[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Rules and Regulations]
[Pages 61402-61555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23643]
Vol. 86
Friday,
No. 212
November 5, 2021
Part II
Department of Labor
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Occupational Safety and Health Administration
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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29 CFR Parts 1910, 1915, 1917, et al.
42 Parts 416, 418, 441, et al.
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COVID-19 Vaccination and Testing; Emergency Temporary Standard;
Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff
Vaccination; Interim Final Rules
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 /
Rules and Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928
[Docket No. OSHA-2021-0007]
RIN 1218-AD42
COVID-19 Vaccination and Testing; Emergency Temporary Standard
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Interim final rule; request for comments.
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SUMMARY: The Occupational Safety and Health Administration (OSHA) is
issuing an emergency temporary standard (ETS) to protect unvaccinated
employees of large employers (100 or more employees) from the risk of
contracting COVID-19 by strongly encouraging vaccination. Covered
employers must develop, implement, and enforce a mandatory COVID-19
vaccination policy, with an exception for employers that instead adopt
a policy requiring employees to either get vaccinated or elect to
undergo regular COVID-19 testing and wear a face covering at work in
lieu of vaccination.
DATES: The rule is effective November 5, 2021. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of November 5, 2021.
Compliance dates: Compliance dates for specific provisions are in
29 CFR 1910.501(m).
Comments: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by December 6, 2021 in Docket No. OSHA-2021-0007. Comments on
the information collection determination described in Additional
Requirements (Section V.K. of this preamble) (OMB review under the
Paperwork Reduction Act of 1995) may be submitted by January 4, 2022 in
Docket No. OSHA-2021-0008.
ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
Edmund C. Baird, the Associate Solicitor for Occupational Safety and
Health, Office of the Solicitor, U.S. Department of Labor, to receive
petitions for review of the ETS. Service can be accomplished by email
to zzSOL-Covid19-ETS@dol.gov.
Written comments. You may submit comments and attachments,
identified by Docket No. OSHA-2021-0007, electronically at
www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the online instructions for making electronic submissions.
Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2021-0007). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2021-0007 at www.regulations.gov. All
comments and submissions are listed in the www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number plus a unique four-digit code. OSHA is
identifying supporting information in this ETS by author name and
publication year, when appropriate. This information can be used to
search for a supporting document in the docket at http://www.regulations.gov. Contact the OSHA Docket Office at 202-693-2350
(TTY number: 877-889-5627) for assistance in locating docket
submissions.
FOR FURTHER INFORMATION CONTACT:
General information and press inquiries: Contact Frank Meilinger,
OSHA Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email ETS@dol.gov.
For technical inquiries: Contact Andrew Levinson, OSHA Directorate
of Standards and Guidance, U.S. Department of Labor; telephone (202)
693-1950; email ETS@dol.gov.
SUPPLEMENTARY INFORMATION: The preamble to the ETS on COVID-19
vaccination and testing follows this outline:
Table of Contents
I. Executive Summary and Request for Comment
A. Executive Summary
B. Request for Comment
II. Pertinent Legal Authority
III. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
IV. Feasibility
A. Technological Feasibility
B. Economic Analysis
V. Additional Requirements
VI. Summary and Explanation
A. Purpose
B. Scope and Application
C. Definitions
D. Employer Policy on Vaccination
E. Determination of Employee Vaccination Status
F. Employer Support for Employee Vaccination
G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
H. Employee Notification to Employer of a Positive COVID-19 Test
and Removal
I. Face Coverings
J. Information Provided to Employees
K. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
L. Availability of Records
M. Dates
N. Severability
O. Incorporation by Reference
VII. Authority and Signature
I. Executive Summary and Request for Comment
A. Executive Summary
This ETS is based on the requirements of the Occupational Safety
and Health Act (OSH Act or Act) and legal precedent arising under the
Act. Under section 6(c)(1) of the OSH Act, 29 U.S.C. 655(c)(1), OSHA
shall issue an ETS if the agency determines that employees are subject
to grave danger from exposure to substances or agents determined to be
toxic or physically harmful or from new hazards, and an ETS is
necessary to protect employees from such danger. These legal
requirements are more fully discussed in Pertinent Legal Authority
(Section II. of this preamble). This ETS does not apply to workplaces
subject to E.O. 14042 on Requiring Coronavirus Disease 2019 Vaccination
for Federal Contractors. In addition, OSHA will treat federal agencies'
compliance with E.O. 14043, and the Safer Federal Workforce Task Force
guidance issued under section 4(e) of Executive Order 13991 and section
2 of Executive Order 14043, as sufficient to meet their obligations
under the OSH Act and E.O. 12196.
COVID-19 has killed over 725,000 people in the United States in
less than two years, and infected millions more (CDC, October 18,
2021--Cumulative US Deaths). The pandemic continues to affect workers
and workplaces. While COVID-19 vaccines authorized or
approved by the U.S. Food and Drug Administration (FDA) effectively
protect vaccinated individuals against severe illness and death from
COVID-19, unvaccinated individuals remain at much higher risk of severe
health outcomes from COVID-19. Further, unvaccinated workers are much
more likely to contract and transmit COVID-19 in the workplace than
vaccinated workers. OSHA has determined that many employees in the U.S.
who are not fully vaccinated against COVID-19 face grave danger from
exposure to SARS-CoV-2 in the workplace. This finding of grave danger
is based on the severe health consequences associated with exposure to
the virus along with evidence demonstrating the transmissibility of the
virus in the workplace and the prevalence of infections in employee
populations, as discussed in Grave Danger (Section III.A. of this
preamble).
OSHA has also determined that an ETS is necessary to protect
unvaccinated workers from the risk of contracting COVID-19 at work, as
discussed in Need for the ETS (Section III.B. of this preamble). At the
present time, workers are becoming seriously ill and dying as a result
of occupational exposures to COVID-19, when a simple measure,
vaccination, can largely prevent those deaths and illnesses. The ETS
protects these workers through the most effective and efficient control
available--vaccination--and further protects workers who remain
unvaccinated through required regular testing, use of face coverings,
and removal of all infected employees from the workplace. OSHA also
concludes, based on its enforcement experience during the pandemic to
date, that continued reliance on existing standards and regulations,
the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1), and
workplace guidance, in lieu of an ETS, is not adequate to protect
unvaccinated employees from the grave danger of being infected by, and
suffering death or serious health consequences from, COVID-19.
OSHA will continue to monitor trends in COVID-19 infections and
death as more of the workforce and the general population become fully
vaccinated against COVID-19 and the pandemic continues to evolve. Where
OSHA finds a grave danger from the virus no longer exists for the
covered workforce (or some portion thereof), or new information
indicates a change in measures necessary to address the grave danger,
OSHA will update this ETS, as appropriate.
This ETS applies to employers with a total of 100 or more employees
at any time the standard is in effect. In light of the unique
occupational safety and health dangers presented by COVID-19, and
against the backdrop of the uncertain economic environment of a
pandemic, OSHA is proceeding in a stepwise fashion in addressing the
emergency this rule covers. OSHA is confident that employers with 100
or more employees have the administrative capacity to implement the
standard's requirements promptly, but is less confident that smaller
employers can do so without undue disruption. OSHA needs additional
time to assess the capacity of smaller employers, and is seeking
comment to help the agency make that determination. Nonetheless, the
agency is acting to protect workers now in adopting a standard that
will reach two-thirds of all private-sector workers in the nation,
including those working in the largest facilities, where the most
deadly outbreaks of COVID-19 can occur.
The agency has also evaluated the feasibility of this ETS and has
determined that the requirements of the ETS are both economically and
technologically feasible, as outlined in Feasibility (Section IV. of
this preamble). The specific requirements of the ETS are outlined and
described in Summary and Explanation (Section VI. of this preamble).
B. Request for Comment
Although this ETS takes effect immediately, it also serves as a
proposal under Section 6(b) of the OSH Act (29 U.S.C. 655(b)) for a
final standard. Accordingly, OSHA seeks comment on all aspects of this
ETS and whether it should be adopted as a final standard. OSHA
encourages commenters to explain why they prefer or disfavor particular
policy choices, and include any relevant studies, experiences,
anecdotes or other information that may help support the comment. In
particular, OSHA seeks comments on the following topics:
1. Employers with fewer than 100 employees. As noted above and
fully discussed in the Summary and Explanation for Scope and
Application (Section VI.B. of this preamble), OSHA has implemented a
100-employee threshold for the requirements of this standard to focus
the ETS on companies that OSHA is confident will have sufficient
administrative systems in place to comply quickly with the ETS. The
agency is moving in a stepwise fashion on the short timeline
necessitated by the danger presented by COVID-19 while soliciting
stakeholder comment and additional information to determine whether to
adjust the scope of the ETS to address smaller employers in the future.
OSHA seeks information about the ability of employers with fewer than
100 employees to implement COVID-19 vaccination and/or testing
programs. Have you instituted vaccination mandates (with or without
alternatives), or requirements for regular COVID-19 testing or face
covering use? What have been the benefits of your approach? What
challenges have you had or could you foresee in implementing such
programs? Is there anything specific to your industry, or the size of
your business, that poses particular obstacles in implementing the
requirements in this standard? How much time would it take, what types
of costs would you incur, and how much would it cost for you to
implement such requirements?
2. Significant Risk. If OSHA were to finalize a rule based on this
ETS, it would be a standard adopted under 6(b) of the OSH Act, which
requires a finding of significant risk from exposure to COVID-19. As
discussed more fully in Pertinent Legal Authority (Section II. of this
preamble), this is a lower showing of risk than grave danger, the
finding required to issue a 6(c) emergency temporary standard. How
should the scope of the rule change to address the significant risk
posed by COVID-19 in the workplace? Should portions of the rule, such
as face coverings, apply to fully vaccinated persons?
3. Prior COVID-19 infections. OSHA determined that workers who have
been infected with COVID-19 but have not been fully vaccinated still
face a grave danger from workplace exposure to SARS-CoV-2. This is an
area of ongoing scientific inquiry. Given scientific uncertainty and
limitations in testing for infection and immunity, OSHA is concerned
that it would be infeasible for employers to operationalize a standard
that would permit or require an exception from vaccination or testing
and face covering based on prior infection with COVID-19. Is there
additional scientific information on this topic that OSHA should
consider as it determines whether to proceed with a permanent rule?
In particular, what scientific criteria can be used to determine
whether a given employee is sufficiently protected against reinfection?
Are there any temporal limits associated with this criteria to account
for potential reductions in immunity over time? Do you require
employees to provide verification of infection with COVID-19? If so,
what kinds of verification do you accept (i.e., PCR testing, antigen
testing, etc.)? What challenges have you
experienced, if any, in operationalizing such an exception?
4. Experience with COVID-19 vaccination policies. Should OSHA
impose a strict vaccination mandate (i.e., all employers required to
implement mandatory vaccination policies as defined in this ETS) with
no alternative compliance option? OSHA seeks information on COVID-19
vaccination policies that employers have implemented to protect
workers. If you have implemented a COVID-19 vaccination policy:
(a) When did you implement it, and what does your policy require?
Was vaccination mandatory or voluntary under the policy? Do you offer
vaccinations on site? What costs associated with vaccination did you
cover under the policy? What percentage of your workforce was
vaccinated as a result? Do you offer paid leave for receiving a
vaccination? If vaccination is mandatory, have employees been resistant
and if so what steps were required to enforce the policy?
(b) How did you verify that employees were vaccinated? Are there
other reliable means of vaccination verification not addressed by the
ETS that should be included? Did you allow attestation where the
employee could not find other proof, and if so, have you experienced
any difficulties with this approach? Have you experienced any issues
with falsified records of vaccination, and if so, how did you deal with
them?
(c) Have you experienced a decrease in infection rates or outbreaks
after implementing this policy?
(d) If you have received any requests for reasonable accommodation
from vaccination, what strategies did you implement to address the
accommodation and ensure worker safety (e.g., telework, working in
isolation, regular testing and the use of face coverings)?
5. COVID-19 testing and removal. OSHA seeks information on COVID-19
testing and removal practices implemented to protect workers.
(a) Do you have a testing and removal policy in your workplace and,
if so, what does it require? How often do you require testing and what
types of testing do you use (e.g., at-home tests, tests performed at
laboratories, tests performed at your worksites)? What costs have you
incurred as part of your testing and removal policies? Do you have
difficulty in finding adequate availability of tests? How often? Have
you experienced any issues with falsified test results, and if so, how
did you deal with them? Have you experienced other difficulties in
implementing a testing and removal scheme, including the length of time
to obtain COVID-19 test results? Do you offer paid leave for testing?
(b) How often have you detected and removed COVID-19 positive
employees from the workplace under this policy? Do you provide paid
leave and job protection to employees you remove for this reason?
(c) Should OSHA require testing more often than on a weekly basis?
6. Face coverings. As discussed in the Summary and Explanation for
Face Coverings (Section VI.I. of this preamble), ASTM released a
specification standard on February 15, 2021, to establish a national
standard baseline for barrier face coverings (ASTM F3502-21). Should
OSHA require the use of face coverings meeting the ASTM F3502-21
standard instead of the face coverings specified by the ETS? If so,
should OSHA also require that such face coverings meet the NIOSH
Workplace Performance or Workplace Performance Plus criteria (see CDC,
September 23, 2021)? Are there particular workplace settings in which
face coverings meeting one standard should be favored over another? Are
there alternative criteria OSHA should consider for face coverings
instead of the F3502-21 standard or NIOSH Workplace Performance or
Workplace Performance Plus criteria? Is there sufficient capacity to
supply face coverings meeting F3502-01 and/or NIOSH Workplace
Performance or Workplace Performance Plus criteria to all employees
covered by the ETS? What costs have you incurred as part of supplying
employees with face coverings meeting the appropriate criteria?
7. Other controls. This ETS requires employees to either be fully
vaccinated against COVID-19 or be tested weekly and wear face
coverings, based on the type of policy their employer adopts. It stops
short of requiring the full suite of workplace controls against SARS-
CoV-2 transmission recommended by OSHA and the CDC, including
distancing, barriers, ventilation, and sanitation. As OSHA explained in
Need for the ETS (Section III.B. of this preamble), OSHA has determined
that it needs more information before imposing these requirements on
the entire scope of industries and employers covered by the standard.
OSHA is interested in hearing from employers about their experience in
implementing a full suite of workplace controls against COVID-19.
What measures have you taken to protect employees against COVID-19
in your workplace? Are there controls that you attempted to employ but
found ineffective or infeasible? What are they? Why did you conclude
that they were they ineffective or infeasible; for example, are there
particular aspects of your workplace or industry that make certain
controls infeasible? Do you require both fully vaccinated and
unvaccinated employees to comply with these controls? Have you
experienced a reduction in infection rates or outbreaks since
implementing these controls?
8. Educational materials. Have you implemented any policies or
provided any information that has been helpful in encouraging an
employee to be vaccinated?
9. Feasibility and health impacts. Do you have any experience or
data that would inform OSHA's estimates in its economic feasibility
analysis or any of the assumptions or estimates used in OSHA's
identification of the number of hospitalizations prevented and lives
saved from its health impacts analysis (see OSHA, October 2021c)?
References
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
23). Types of Masks and Respirators. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html.
(CDC, September 23, 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
II. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ``to assure so far as possible every
working man and woman in the Nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
this end, Congress authorized the Secretary of Labor (Secretary) to
promulgate and enforce occupational safety and health standards under
sections 6(b) and (c) of the OSH Act.\1\ 29 U.S.C. 655(b). These
provisions provide bases for issuing occupational safety and health
standards under the Act. Once OSHA has established as a threshold
matter that a health standard is necessary under section 6(b) or (c)--
i.e., to reduce
a significant risk of material health impairment, or a grave danger to
employee health--the Act gives the Secretary ``almost unlimited
discretion to devise means to achieve the congressionally mandated
goal'' of protecting employee health, subject to the constraints of
feasibility. See United Steelworkers of Am. v. Marshall, 647 F.2d 1189,
1230 (D.C. Cir. 1981). A standard's individual requirements need only
be ``reasonably related'' to the purpose of ensuring a safe and
healthful working environment. Id. at 1237, 1241; see also Forging
Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447 (4th Cir. 1985).
OSHA's authority to regulate employers is hedged by constitutional
considerations and, pursuant to section 4(b)(1) of the OSH Act, the
regulations and enforcement policies of other federal agencies. See,
e.g., Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241 (2002).
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\1\ The Secretary has delegated most of his duties under the OSH
Act to the Assistant Secretary of Labor for Occupational Safety and
Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020).
This section uses the terms Secretary and OSHA interchangeably.
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The OSH Act in section 6(c)(1) states that the Secretary ``shall''
issue an emergency temporary standard (ETS) upon a finding that the ETS
is necessary to address a grave danger to workers. See 29 U.S.C.
655(c). In particular, the Secretary shall provide, without regard to
the requirements of chapter 5, title 5, United States Code, for an
emergency temporary standard to take immediate effect upon publication
in the Federal Register if the Secretary makes two determinations: That
employees are exposed to grave danger from exposure to substances or
agents determined to be toxic or physically harmful or from new
hazards, and that such emergency standard is necessary to protect
employees from such danger. 29 U.S.C. 655(c)(1). A separate section of
the OSH Act, section 8(c), authorizes the Secretary to prescribe
regulations requiring employers to make, keep, and preserve records
that are necessary or appropriate for the enforcement of the Act. 29
U.S.C. 657(c)(1). Section 8(c) also provides that the Secretary shall
require employers to keep records of, and report, work-related deaths
and illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1), exempts the Secretary from
procedural requirements contained in the OSH Act and the Administrative
Procedure Act, including those for public notice, comments, and a
rulemaking hearing. See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. 552, 553.
The Secretary must issue an ETS in situations where employees are
exposed to a ``grave danger'' and immediate action is necessary to
protect those employees from such danger. 29 U.S.C. 655(c)(1); Pub.
Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983). The determination of what exact level of risk constitutes a
``grave danger'' is a ``policy consideration that belongs, in the first
instance, to the Agency.'' Asbestos Info. Ass'n, 727 F.2d at 425
(accepting OSHA's determination that eighty lives at risk over six
months was a grave danger); Indus. Union Dep't, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 655 n.62 (1980). However, a ``grave
danger'' represents a risk greater than the ``significant risk'' that
OSHA must show in order to promulgate a permanent standard under
section 6(b) of the OSH Act, 29 U.S.C. 655(b). Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW v. Donovan, 590
F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir.
1985); see also Indus. Union Dep't, AFL-CIO, 448 U.S. at 640 n.45
(noting the distinction between the standard for risk findings in
permanent standards and ETSs).
In determining the type of health effects that may constitute a
``grave danger'' under the OSH Act, the Fifth Circuit emphasized ``the
danger of incurable, permanent, or fatal consequences to workers, as
opposed to easily curable and fleeting effects on their health.'' Fla.
Peach Growers Ass'n, Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 132
(5th Cir. 1974). Although the findings of grave danger and necessity
must be based on evidence of ``actual, prevailing industrial
conditions,'' see Int'l Union, 590 F. Supp. at 751, when OSHA
determines that exposure to a particular hazard would pose a grave
danger to workers, OSHA can assume an exposure to a grave danger
wherever that hazard is present in a workplace. Dry Color Mfrs. Ass'n,
Inc. v. Dep't of Labor, 486 F.2d 98, 102 n.3 (3d Cir. 1973).
In demonstrating whether OSHA had shown that an ETS is necessary,
the Fifth Circuit considered whether OSHA had another available means
of addressing the risk that would not require an ETS. Asbestos Info.
Ass'n, 727 F.2d at 426 (holding that necessity had not been proven
where OSHA could have increased enforcement of already-existing
standards to address the grave risk to workers from asbestos exposure).
Additionally, a standard must be both economically and technologically
feasible in order to be ``reasonably necessary and appropriate'' under
section 3(8) and, by inference, ``necessary'' under section 6(c)(1)(B)
of the Act. Cf. Am. Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490,
513 n.31 (1981) (noting ``any standard that was not economically or
technologically feasible would a fortiori not be `reasonably necessary
or appropriate' '' as required by the OSH Act's definition of
``occupational safety and health standard'' in section 3(8)); see also
Florida Peach Growers, 489 F.2d at 130 (recognizing that the
promulgation of any standard, including an ETS, must account for its
economic effect). However, given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make a feasibility showing with the same rigor as in
ordinary section 6(b) rulemaking. Asbestos Info. Ass'n, 727 F.2d at 424
n.18.
On judicial review of an ETS, OSHA is entitled to great deference
on the determinations of grave danger and necessity required under
section 6(c)(1). See, e.g., Pub. Citizen Health Research Grp., 702 F.2d
at 1156; Asbestos Info. Ass'n, 727 F.2d at 422 (judicial review of
these legislative determinations requires deference to the agency); cf.
Am. Dental Ass'n v. Martin, 984 F.2d 823, 831 (7th Cir. 1993) (``the
duty of a reviewing court of generalist judges is merely to patrol the
boundary of reasonableness''). These determinations are ``essentially
legislative and rooted in inferences from complex scientific and
factual data.'' Pub. Citizen Health Research Grp., 702 F.2d at 1156.
The agency is not required to support its conclusions ``with anything
approaching scientific certainty,'' Indus. Union Dep't, AFL-CIO, 448
U.S. at 656, and has the ``prerogative to choose between conflicting
evidence.'' Asbestos Info. Ass'n, 727 F.2d at 425.
The determinations of the Secretary in issuing standards under
section 6 of the OSH Act, including ETSs, must be affirmed if supported
by ``substantial evidence in the record considered as a whole.'' 29
U.S.C. 655(f). The Supreme Court described substantial evidence as
``such relevant evidence as a reasonable mind might accept as adequate
to support a conclusion.'' Am. Textile Mfrs. Inst., 452 U.S. at 522-23
(quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)). The
Court also noted that ``the possibility of drawing two inconsistent
conclusions from the evidence does not prevent an administrative
agency's finding from being supported by substantial evidence.'' Id. at
523 (quoting Consolo v. FMC, 383 U.S. 607, 620 (1966)). The Fifth
Circuit, recognizing the size and complexity of the rulemaking record
before it in the case of OSHA's ETS for organophosphorus pesticides,
stated that a court's function in reviewing an ETS to determine whether
it meets the substantial evidence standard is ``basically [to]
determine whether the
Secretary carried out his essentially legislative task in a manner
reasonable under the state of the record before him.'' Fla Peach
Growers Ass'n, 489 F.2d at 129.
Although Congress waived the ordinary rulemaking procedures in the
interest of ``permitting rapid action to meet emergencies,'' section
6(e) of the OSH Act, 29 U.S.C. 655(e), requires OSHA to include a
statement of reasons for its action when it issues any standard. Dry
Color Mfrs., 486 F.2d at 105-06 (finding OSHA's statement of reasons
inadequate). By requiring the agency to articulate its reasons for
issuing an ETS, the requirement acts as ``an essential safeguard to
emergency temporary standard-setting.'' Id. at 106. However, the Third
Circuit noted that it did not require justification of ``every
substance, type of use or production technique,'' but rather a
``general explanation'' of why the standard is necessary. Id. at 107.
ETSs are, by design, temporary in nature. Under section 6(c)(3), an
ETS serves as a proposal for a permanent standard in accordance with
section 6(b) of the OSH Act (permanent standards), and the Act calls
for the permanent standard to be finalized within six months after
publication of the ETS. 29 U.S.C. 655(c)(3); see Fla. Peach Growers
Ass'n, 489 F.2d at 124. The ETS is effective ``until superseded by a
standard promulgated in accordance with'' section 6(c)(3). 29 U.S.C.
655(c)(2).
Section 6(c)(1) states that the Secretary ``shall'' provide for an
ETS when OSHA makes the prerequisite findings of grave danger and
necessity. See Pub. Citizen Health Research Grp., 702 F.2d at 1156
(noting the mandatory language of section 6(c)). OSHA is entitled to
great deference in its determinations, and it must also account for
``the fact that `the interests at stake are not merely economic
interests in a license or a rate structure, but personal interests in
life and health.' '' Id. (quoting Wellford v. Ruckelshaus, 439 F.2d
598, 601 (D.C. Cir. 1971)).
When OSHA issues a standard pursuant to section 6--whether
permanent or an ETS--section 18 of the OSH Act provides that OSHA's
standard preempts any state occupational safety or health standard
``relating to [the same] occupational safety or health issue'' as the
Federal standard. 29 U.S.C. 667(b); see also Gade v. Nat'l Solid Wastes
Mgmt. Ass'n, 505 U.S. 88, 97 (1992). A state can avoid preemption only
if it submits, and receives Federal approval for, a state plan for the
development and enforcement of standards pursuant to section 18 of the
Act, which must be ``at least as effective'' as the Federal standards.
29 U.S.C. 667; Indus. Truck Ass'n v. Henry, 125 F.3d 1305, 1311 (9th
Cir. 1997). However, the OSH Act does not preempt state laws of
``general applicability'' that regulate workers and non-workers alike,
so long as they do not conflict with an OSHA standard. Gade, 505 U.S.
at 107.
As discussed in detail elsewhere in this preamble, OSHA has
determined that a grave danger exists necessitating a new ETS (see
Grave Danger and Need for the ETS, Sections III.A. and III.B. of this
preamble), and that compliance with this ETS is feasible for covered
employers (see Feasibility, Section IV. of this preamble). OSHA has
also provided a more detailed explanation of each provision of this ETS
in Summary and Explanation (Section VI. of this preamble). In addition,
OSHA wishes to provide here some general guidance on its legal
authority to regulate COVID-19 hazards, and for particular provisions
of this ETS.
As a threshold matter, OSHA's authority to regulate workplace
exposure to biological hazards like SARS-CoV-2 is well-established.
Section 6(b)(5) of the OSH Act uses similar language to section
6(c)(1)(A): The former sets forth requirements for promulgating
permanent standards addressing ``toxic materials or harmful physical
agents,'' and the latter authorizes OSHA to promulgate an ETS
addressing ``substances or agents determined to be toxic or physically
harmful'' (as well as ``new hazards''). OSHA has consistently
identified biological hazards similar to SARS-CoV-2, as well as SARS-
CoV-2 itself, to be ``toxic materials or harmful physical agents''
under the Act. Indeed, in its exposure and medical records access
regulation, OSHA has defined ``toxic materials or harmful physical
agents'' to include ``any . . . biological agent (bacteria, virus,
fungus, etc.)'' for which there is evidence that it poses a chronic or
acute health hazard. 29 CFR 1910.1020(c)(13). And in addition to
previously regulating exposure to SARS-CoV-2 as a new and physically
harmful agent in the Healthcare ETS (see, e.g., 86 FR at 32381), OSHA
has also previously regulated biological hazards like SARS-CoV-2 as
health hazards under section 6(b)(5), for example in the Bloodborne
Pathogens (BBP) standard, 29 CFR 1910.1030, which addresses workplace
exposure to HIV and Hepatitis B. The BBP standard was upheld (except as
to application in certain limited industries) in American Dental
Association, which observed that ``the infectious character'' of the
regulated bloodborne diseases might warrant ``more regulation than
would be necessary in the case of a noncommunicable disease.'' 984 F.2d
at 826. In addition, in the preamble to the respiratory protection
standard, 29 CFR 1910.134, which was also promulgated under section
6(b)(5), ``OSHA emphasize[d] that [the] respiratory protection standard
does apply to biological hazards.'' Respiratory Protection, 63 FR 1152-
01, 1180 (Jan. 8, 1998) (citing Mahone Grain Corp., 10 BNA OSHC 1275
(No. 77-3041, 1981)).
In addition to being a physically harmful agent covered by section
6(c)(1)(A), SARS-CoV-2 is also, without question, a ``new hazard''
covered by this provision, as discussed in more detail in Grave Danger
(Section III.A. of this preamble). SARS-CoV-2 was not known to exist
until January 2020, and since then more than 725,000 people have died
from COVID-19 in the U.S. alone (CDC, October 18, 2021--Cumulative US
Deaths).
Turning to specific provisions of this standard, the vaccination
requirements in this ETS are also well within the bounds of OSHA's
authority. Vaccination can be a critical tool in the pursuit of health
and safety goals, particularly in response to an infectious and highly
communicable disease. See, e.g., Jacobson v. Commonwealth of Mass., 197
U.S. 11, 27-28 (1905) (recognizing use of smallpox vaccine as a
reasonable measure to protect public health and safety); Klaassen v.
Trustees of Ind. Univ., 7 F.4th 592, 593 (7th Cir. 2021) (citing
Jacobson and noting that vaccination may be an appropriate safety
measure against SARS-CoV-2 as ``[v]accination protects not only the
vaccinated persons but also those who come in contact with them''). And
the OSH Act itself explicitly acknowledges that such treatments might
be necessary, in some circumstances. 29 U.S.C. 669(a)(5) (providing in
the Act's provisions on research and related activities conducted by
the Secretary of Health and Human Services to aid OSHA in its
formulation of health and safety standards that ``[n]othing in this or
any other provision of this Act shall be deemed to authorize or require
medical examination, immunization, or treatment for those who object
thereto on religious grounds, except where such is necessary for the
protection of the health or safety of others.'' (emphasis added)). In
recognition of the health and safety benefits provided by vaccination,
OSHA has previously exercised its authority to promulgate vaccine-
related requirements in the COVID-19 Healthcare ETS (29 CFR
1910.502(m))
and the BBP standard (29 CFR 1910.1030(f)). The BBP standard
illustrates congressional understanding that the statutory delegation
of authority to OSHA to issue standards includes authority for vaccine
provisions, where appropriate. See Public Law 102-170, Title I, Section
100, 105 Stat. 1107 (1991) (directing OSHA to complete the BBP
rulemaking by a date certain, and providing that if OSHA did not do so,
the proposed rule, which included a vaccine provision, would become the
final standard).
Additionally, OSHA's authority to require employers to bear the
costs of particular provisions of a standard is solidly grounded in the
OSH Act. The Act reflects Congress's determination that the costs of
compliance with the Act and OSHA standards are part of the cost of
doing business and OSHA may foreclose employers from shifting those
costs to employees. See Am. Textile Mfrs. Inst., 452 U.S. at 514;
Phelps Dodge Corp. v. OSHRC, 725 F.2d 1237, 1239-40 (9th Cir. 1984);
see also Sec'y of Labor v. Beverly Healthcare-Hillview, 541 F.3d 193
(3d Cir. 2008). Consistent with this authority, OSHA has largely
required employers to bear the costs of the provisions of this ETS,
including the typical costs associated with vaccination. The allocation
of vaccination costs to employers in this ETS is similar to OSHA's
treatment of vaccine-related costs in the COVID-19 Healthcare ETS and
the BBP standards. See 29 CFR 1910.502(m), (p); 29 CFR
1910.1030(f)(1)(ii)(A).
The OSH Act provides OSHA with discretion, however, to decide
whether to impose certain costs--such as those related to medical
examinations or other tests--on employers ``[w]here [it determines that
such costs are] appropriate.'' 29 U.S.C. 655(b)(7). OSHA has determined
that for purposes of this ETS, it would not be ``appropriate'' to
impose on employers any costs associated with COVID-19 testing for
employees who choose not to be vaccinated. For most of the agency's
existing standards containing medical testing and removal provisions,
OSHA has found it necessary to impose the costs of such provisions on
employers in order to remove barriers to employee participation in
medical examinations that are critical to effectuating the standards'
safety and health protections. See United Steelworkers of Am., 647 F.2d
at 1229-31, 1237-38. However, as explained in greater detail elsewhere
in this preamble (see Need for the ETS, Section III.B. of this
preamble), the ETS's safety and health protections are best effectuated
by employee vaccination, not testing. Accordingly, OSHA only requires
employers to bear the costs of employee compliance with the preferred,
and more protective, vaccination provision, but not costs associated
with testing. The agency does not believe it appropriate to impose the
costs of testing on an employer where an employee has made an
individual choice to pursue a less protective option. For the same
reasons, OSHA has also determined that it is not appropriate to require
employers to pay for face coverings for employees who choose not to be
vaccinated.\2\
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\2\ OSHA notes that while the ETS does not impose these testing
or face covering costs on employers, in some circumstances employers
may be required to pay for the costs related to testing and/or face
coverings by other laws, regulations, or collectively negotiated
agreements. OSHA has no authority under the OSH Act to determine
whether such obligations under other laws, regulations, or
agreements might exist.
---------------------------------------------------------------------------
Finally, the Act and its legislative history ``both demonstrate
unmistakably'' OSHA's authority to require employers to temporarily
remove workers from the workplace to prevent exposure to a health
hazard. United Steelworkers of Am., 647 F.2d at 1230. And again, this
is an authority OSHA has repeatedly exercised in prior standards,
including in: COVID-19 Healthcare ETS (29 CFR 1910.502); Lead (29 CFR
1910.1025); Cadmium (29 CFR 1910.1027); Benzene (29 CFR 1910.1028);
Formaldehyde (29 CFR 1910.1048); Methylenedianiline (29 CFR 1910.1050);
Methylene Chloride (29 CFR 1910.1052); and Beryllium (29 CFR
1910.1024). It is equally appropriate to impose that obligation here.
For all of these reasons, as well as those explained more fully in
other areas of this preamble, OSHA has the authority--and obligation--
to promulgate this ETS.
References
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
III. Rationale for the ETS
A. Grave Danger
I. Introduction
Section 6(c)(1) of the OSH Act requires the Secretary to issue an
ETS in situations where employees are exposed to a ``grave danger'' and
immediate action is necessary to protect those employees from such
danger (29 U.S.C. 655(c)(1)). Consistent with its legal duties, OSHA is
issuing this ETS to address the grave danger posed by occupational
exposure to SARS-CoV-2, the virus that causes COVID-19.\3\ OSHA has
determined that occupational exposure to SARS-CoV-2, including the
Delta variant (B.1.617.2 and AY lineages), presents a grave danger to
unvaccinated workers in the U.S., with several exceptions explained
below.\4\ This finding of grave danger is based on the science of how
the virus spreads, the transmissibility of the disease in workplaces,
and the serious adverse health effects, including death, that can be
suffered by those who are diagnosed with COVID-19. The protections of
this ETS--which will apply, with some limitations, to a broad range of
workplace settings where exposure to SARS-CoV-2 may occur--are designed
to protect employees from infection with SARS-CoV-2 and from the dire,
sometimes fatal, consequences of such infection.
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\3\ OSHA is defining the grave danger as workplace exposure to
SARS-CoV-2, the virus that causes the development of COVID-19.
COVID-19 is the disease that can occur in people exposed to SARS-
CoV-2, and that leads to the health effects described in this
section. This distinction applies despite OSHA's use of the terms
SARS-CoV-2 and COVID-19 interchangeably in some parts of this
preamble.
\4\ OSHA refers to the grave danger from occupational exposure
to SARS-CoV-2 throughout this document. Those references are
intended to encompass exposure to SARS-CoV-2 and all variants of
SARS-CoV-2, including the Delta variant.
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The fact that COVID-19 is not a uniquely work-related hazard does
not change the determination that it is a grave danger to which
employees are exposed, nor does it excuse employers from their duty to
protect employees from the occupational transmission of SARS-CoV-2. The
OSH Act is intended to ``assure so far as possible every working man
and woman in the Nation safe and healthful working conditions'' (29
U.S.C. 651(b)), and there is nothing in the Act to suggest that its
protections do not extend to hazards which might occur outside of the
workplace as well as within. Indeed, COVID-19 is not the first hazard
that OSHA has regulated that occurs both inside and outside the
workplace. For example, the hazard of noise is not unique to the
workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise
Exposure standard (29 CFR 1910.95) (Forging Industry Ass'n v. Sec' of
Labor, 773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by
bloodborne pathogens, including HIV/AIDS and hepatitis B, are also not
unique to the workplace, but the Seventh Circuit upheld the majority of
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) (Am. Dental
Ass'n v. Martin, 984 F.2d 823 (7th Cir. 1993)). OSHA's Sanitation
standard, 29 CFR 1910.141, which requires measures such as cleaning,
waste disposal, potable water, toilets, and washing facilities,
addresses hazards that exist everywhere--both within and outside of
workplaces. Moreover, employees have more freedom to control their
environment outside of work, and to make decisions about their behavior
and their contact with others to better minimize their risk of
exposure. However, during the workday, while under the control of their
employer, workers may have little ability to limit contact with
coworkers, clients, members of the public, patients, and others, any
one of whom could represent a source of exposure to SARS-CoV-2. OSHA
has a mandate to protect employees from hazards they are exposed to at
work, even if they may be exposed to similar hazards outside of work.
As described above in Pertinent Legal Authority (Section II. of
this preamble), ``grave danger'' indicates a risk that is more than
``significant'' (Int'l Union, United Auto., Aerospace, & Agr. Implement
Workers of Am., UAW v. Donovan, 590 F. Supp. 747, 755-56 (D.D.C. 1984);
Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 640
n.45, 655 (1980) (stating that a rate of 1 worker in 1,000 workers
suffering a given health effect constitutes a ``significant'' risk)).
``Grave danger,'' according to one court, refers to ``the danger of
incurable, permanent, or fatal consequences to workers, as opposed to
easily curable and fleeting effects on their health'' (Fla. Peach
Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir.
1974)). Fleeting effects were described as nausea, excessive
salivation, perspiration, or blurred vision and were considered so
minor that they often went unreported; these effects are in stark
contrast with the adverse health effects of COVID-19 infections, which
are formally referenced as ranging from ``mild'' to ``critical,'' \5\
but which can involve significant illness, hospital stays, ICU care,
death, and long-term health complications for survivors. Beyond this,
however, ``the determination of what constitutes a risk worthy of
Agency action is a policy consideration that belongs, in the first
instance, to the Agency'' (Asbestos Info. Ass'n/N. Am. v. OSHA, 727
F.2d 415, 425 (5th Cir. 1984)).
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\5\ See the definitions for the different levels of severity of
COVID-19 illness in the National Institutes of Health's COVID-19
treatment guidelines (NIH, October 12, 2021).
---------------------------------------------------------------------------
In the context of ordinary 6(b) rulemaking, the Supreme Court has
said that the OSH Act is not a ``mathematical straitjacket,'' nor does
it require the agency to support its findings ``with anything
approaching scientific certainty,'' particularly when operating on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 655-56 (1980)). Courts reviewing
OSHA's determination of grave danger do so with ``great deference''
(Pub. Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156
(D.C. Cir. 1983)). In one case, the Fifth Circuit, in reviewing an OSHA
ETS for asbestos, declined to question the agency's finding that 80
worker lives at risk nationwide over six months constituted a grave
danger (Asbestos Info. Ass'n/N. Am., 727 F.2d at 424). OSHA estimates
that this ETS would save over 6,500 worker lives and prevent over
250,000 hospitalizations over the course of the next six months (OSHA,
October 2021c). Here, the mortality and morbidity risk to employees
from COVID-19 is so dire that the grave danger from exposures to SARS-
CoV-2 is clear.
SARS-CoV-2 is both a physically harmful agent and a new hazard (see
29 U.S.C. 655(c)(1)(A)). The majority of OSHA's previous ETSs addressed
toxic substances that had been familiar to the agency for many years
prior to issuance of the ETS. OSHA's Healthcare ETS, issued in response
to COVID-19 earlier this year, is one notable exception. In most cases,
OSHA's ETSs were issued in response to new information about substances
that had been used in workplaces for decades (e.g., Vinyl Chloride (39
FR 12342 (April 5, 1974)); Benzene (42 FR 22516 (May 3, 1977)); 1,2-
Dibromo-3-chloropropane (42 FR 45536 (Sept. 9, 1977))). In some cases,
the hazards of the toxic substance were already so well established
that OSHA promulgated an ETS simply to update an existing standard
(e.g., Vinyl cyanide (43 FR 2586 (Jan. 17, 1978))). The COVID-19
Healthcare ETS, which was issued in June 2021, was the sole instance in
which OSHA issued an ETS to address a grave danger from a substance
that had only recently come into existence. Although that action by the
agency was challenged, the case has not gone to briefing (see United
Food & Commercial Workers Int'l Union, AFL-CIO, CLC and AFL-CIO v.
OSHA, Dep't of Labor, D.C. Circuit No. 21-1143). Thus, no court has had
occasion to examine OSHA's authority under section (6)(c) of the OSH
Act (29 U.S.C. 655(c)) to address a grave danger from a ``new hazard.''
Yet by any measure, SARS-CoV-2 is a new hazard. Unlike any of the
hazards addressed in previous ETSs, there were no documented cases of
SARS-CoV-2 infections in the United States until January 2020. Since
then, more than 725,000 people have died in the U.S. alone (CDC,
October 18, 2021--Cumulative US Deaths). The pandemic continues to
affect workers and workplaces, with workplace exposures leading to
further exposures among workers' families and communities. Clearly,
SARS-CoV-2 is both a physically harmful agent and a new hazard that
presents a grave danger to workers in the U.S.
Published on June 21, 2021, OSHA's Healthcare ETS (86 FR 32376) was
written in response to the grave danger posed to healthcare workers in
the United States who faced a heightened risk of infection from COVID-
19. In the healthcare ETS, OSHA described its finding of grave danger
for healthcare and healthcare support service workers (see 86 FR 32381-
32412). OSHA now finds that all unvaccinated workers, with some
exceptions, face a grave danger from the SARS-CoV-2 virus.\6\
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\6\ When OSHA refers to ``unvaccinated'' individuals in its
grave danger finding, it means all individuals who are not fully
vaccinated against COVID-19, i.e., those who are completely
unvaccinated and those who are partially vaccinated.
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II. Nature of the Disease
The health effects of symptomatic COVID-19 illness can range from
mild disease consisting of fever or chills, cough, and shortness of
breath to severe disease. Severe cases can involve respiratory failure,
blood clots, long-term cardiovascular and neurological effects, and
organ damage, which can lead to hospitalization, ICU admission, and
death (see 86 FR 32383-32388; NINDS, September 2, 2021). Even in the
short time since the Healthcare ETS's publication in June 2021, the
risk posed by COVID-19 has changed meaningfully. Since OSHA considered
the impact of COVID-19 when promulgating the Healthcare ETS, over
135,000 additional Americans have died from COVID-19, and over 933,000
have been hospitalized, (CDC, October 18, 2021--Cumulative US Deaths;
CDC, May 28, 2021; CDC, October 18, 2021--Weekly Review). In August
2021, COVID-19 was the third leading cause of death in the United
States, trailing only heart disease and cancer (Ortaliza et al., August
27, 2021). By September 20, 2021, COVID-19 had killed as many Americans
as the 1918-1919 flu pandemic (Johnson, September 20, 2021).
While the Healthcare ETS addresses the risk of illness and death
from
COVID-19 as the SARS-CoV-2 virus continues to change over time, it does
not specifically address the increases in infectiousness and
transmission, and the potentially more severe health effects, related
to the Delta variant. The rapid rise to predominance of the Delta
variant in the U.S. occurred shortly after the ETS was published. At
this time, the widespread prevalence of the Delta variant and its
increased transmissibility have resulted in increased risk of exposure
and disease relative to the previously-dominant strains of the SARS-
CoV-2 virus. Adding to the information covered in the Healthcare ETS,
the following sections provide a brief review of SARS-CoV-2 and
describe the characteristics of the Delta variant that are different
from previous versions of SARS-CoV-2 and have changed the risks posed
by COVID-19. The agency specifically references the material presented
in the Healthcare ETS, which is still relevant to this analysis, to
support OSHA's finding of grave danger. Taken together, the information
available to OSHA demonstrates that SARS-CoV-2 poses a grave danger to
unvaccinated workers across all industry sectors.
a. Variants of SARS-CoV-2
Viral mutations have been a serious concern of scientists, public
health experts, and policymakers from the beginning of the COVID-19
pandemic. Viral mutations can affect how a virus interacts with a
cell--altering the virus's transmissibility, infection severity, and
sensitivity to vaccines. The U.S. government's SARS-CoV-2 Interagency
Group has a variant classification scheme that defines four classes of
SARS-CoV-2 variants: Variants Being Monitored (VBM), Variants of
Interest (VOI), Variants of Concern (VOC), and Variants of High
Consequence (VOHC). These variant designations are based on their
``proportions at the national and regional levels and the potential or
known impact of the constellation of mutations on the effectiveness of
medical countermeasures, severity of disease, and ability to spread
from person to person'' (CDC, October 4, 2021), with VOIs considered
less serious than VOCs and VOCs considered less serious than VOHCs. As
of early October 2021, the CDC was monitoring 10 VBMs--Alpha (B.1.1.7,
Q.1-Q.8), Beta (B.1.351, B.1.351.2, B.1.351.3), Gamma (P.1, P.1.1,
P.1.2), Epsilon (B.1.427 and B.1.429), Eta (B.1.525), Iota (B.1.526),
Kappa (B.1.617.1), B.1.617.3, Mu (B.1.621, B.1.621.1), and Zeta (P.2)--
and one VOC--Delta (B.1.617.2 and AY.1 sublineages)--in the U.S. (CDC,
October 4, 2021). CDC defines a VOC as ``[a] variant for which there is
evidence of an increase in transmissibility, more severe disease (e.g.,
increased hospitalizations or deaths), significant reduction in
neutralization by antibodies generated during previous infection or
vaccination, reduced effectiveness of treatments or vaccines, or
diagnostic detection failures'' (CDC, October 4, 2021).
While the proportions of SARS-CoV-2 variants in the United States
have shifted over time (CDC, May 24, 2021c; CDC, October 18, 2021--
Variant Proportions, July through October 2021), the primary variant
that drove COVID-19 transmission in the late Winter and Spring of 2021
was the Alpha variant. The CDC noted that Alpha is associated with an
increase in transmission, as well as potentially increased incidences
of hospitalization and death, compared to the predominant variants
before its emergence (CDC, October 4, 2021; Pascall et al., August 24,
2021; Julin et al., September 22, 2021). As Alpha transmission subsided
in the United States during the late Spring and early Summer of 2021,
Delta emerged and quickly became the predominant variant in the U.S. by
July 3, 2021 (CDC, October 18, 2021--Variant Proportions, July through
October 2021). Delta now accounts for more than 99% of circulating
virus nationwide (CDC, October 18, 2021--Variant Proportions, July
through October 2021).
FDA authorized and approved COVID-19 vaccines currently work well
against all of these variants; however, there are differences in
various variants' ability to spread and the likelihood of infection to
cause severe illness. Data on the Beta and Gamma variants do not
indicate that infections from these variants caused more severe illness
or death than other VOCs. Data on the Alpha variant does indicate its
ability to cause more severe illness and death in infected individuals.
And some data on the Delta variant suggests that the Delta variant may
cause more severe illness than previous variants, including Alpha, in
unvaccinated individuals (CDC, October 4, 2021).
The emergence of the Delta variant, along with other VOCs, has
resulted in a more deadly pandemic (Fisman and Tuite, July 12, 2021).
While the Delta variant is the most transmissible SARS-CoV-2 variant to
date, the possibility remains for the rise of future VOCs, and even
more dangerous VOHCs, as the virus continues to spread and mutate.
Inadequate vaccination rates and the abundance of transmission create
an environment that can foster the development of new variants that
could be similarly, or even more, disruptive (Liu and Rocklov, August,
4, 2021). In this context, it is critical that OSHA address the grave
danger from COVID-19 that unvaccinated workers are currently facing by
requiring vaccination and the other measures included in this rule, in
order to significantly slow the transmission of COVID-19 in workers and
workplaces and mitigate the rise of future variants.
b. Transmission
SARS-CoV-2 is a highly transmissible virus, regardless of variant.
Since the first case was detected in the U.S., there have been close to
45 million reported cases of COVID-19, affecting every state and
territory, with thousands more infected each day (CDC, October 18,
2021--Cumulative US Cases), and some indication that these numbers
continue to underestimate the full burden of disease (CDC, July 27,
2021). According to the CDC, the primary way the SARS-CoV-2 virus
spreads from an infected person to others is through the respiratory
droplets that are produced when an infected person coughs, sneezes,
sings, talks, or breathes (CDC, May 7, 2021). Infection could then
occur when another person breathes in the virus. Most commonly this
occurs when people are in close contact with one another in indoor
spaces (within approximately six feet for at least fifteen minutes)
(CDC, August 13, 2021). Additionally, airborne transmission may occur
in indoor spaces without adequate ventilation where small respiratory
particles are able to remain suspended in the air and accumulate (CDC,
May 7, 2021; Fennelly, July 24, 2020). While scientists' understanding
of the Delta variant's virology is evolving and remains at the frontier
of science, current data shows that the routes of transmission remain
the same for all currently-identified SARS-CoV-2 variants. In addition,
all variants can be transmitted by people who are pre-symptomatic
(i.e., people who are infected but do not yet feel sick) or
asymptomatic (i.e., people who are infected but never feel any symptoms
of COVID-19), as well as those who are symptomatic. Pre-symptomatic and
asymptomatic transmission continue to pose serious challenges to
containing the spread of COVID-19. For more extensive information on
transmission routes, as well as pre-symptomatic and asymptomatic
transmission, see the preamble to the Healthcare ETS (86 FR
32392-32396), which is hereby included in the record of this ETS.\7\
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\7\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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The Delta variant is transmitted from infectious individuals via
the same routes as previous variants, but is much more transmissible.
Specifically, Delta differs from previous dominant variants of SARS-
CoV-2 in terms of the amplification of viral particles expelled from
infected individuals. Testing of Delta-infected individuals indicates
that their viral loads are--on average--approximately 1,000x greater
than those of the SARS-CoV-2 variants from the first COVID-19 wave in
early 2020. This finding suggests much faster replication of viral
particles during early infection with the Delta variant, resulting in
greater infectiousness (contagiousness) when compared to earlier
versions of SARS-CoV-2 (Li et al., July 12, 2021).
The transmissibility of viruses is measured in part by the average
number of subsequently-infected people (or secondary cases) that are
expected to occur from each existing case (often referred to as
R0). Several comparisons of the transmissibility of the
initial SARS-CoV-2 variants to the Delta variant have shown that Delta
is approximately twice as transmissible (contagious) as previous
versions of SARS-CoV-2 (CDC, August 26, 2021; Riou and Althaus, January
30, 2020; Li et al., July 12, 2021; Liu and Rocklov, August, 4, 2021),
likely the result of higher initial viral loads during the pre-
symptomatic phase (Li et al., July 12, 2021). In addition, as described
further below, data on Delta shows that both unvaccinated and
vaccinated individuals are more likely to transmit Delta than previous
variants (Liu and Rocklov, August, 4, 2021; Eyre et al., September 29,
2021), making it especially dangerous to those who remain unvaccinated.
c. Health Effects
COVID-19 infections can lead to death. As reported in the
Healthcare ETS, by May 24, 2021, there had been 587,432 deaths and
32,947,548 million infections in the U.S. alone (CDC, May 24, 2021a;
CDC, May 24, 2021b). At that point in the pandemic, 1.8 out of every
1,000 people in the U.S. had died from COVID-19 (CDC, May 24, 2021a).
Since then, reported cases have increased to 44,857,861 and the number
of deaths has increased to 723,205 (CDC, October 18, 2021- Cumulative
US Cases; Cumulative US Deaths). By September 2021, an astounding 1 in
500 Americans had died from COVID-19 (Keating, September 15, 2021).
Updated mortality data \8\ currently indicate that people of working
age (18-64 years old) now have a 1 in 202 chance of dying when they
contract the disease, with the risk much higher (1 in 72) for those
aged 50-64 (CDC, October 18, 2021--Demographic Trends, Cases by Age
Group; CDC, October 18, 2021--Demographic Trends, Deaths by Age Group).
For a more in-depth description of the health effects resulting from
SARS-CoV-2 infection, see the preamble to the Healthcare ETS (86 FR
32383-32392), which is hereby included in the record of this ETS.\9\
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\8\ Risk of death is based on averages from reported CDC data.
Risks of hospitalization and death are much higher in unvaccinated
individuals, as discussed further in Grave Danger, Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2.
\9\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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Apart from fatal cases, COVID-19 can cause serious illness,
including long-lasting effects on health. Many patients who become ill
with COVID-19 require hospitalization. Indeed, updated CDC
hospitalization and mortality data indicate that working age Americans
(18-64 years old) now have a 1 in 14 chance of hospitalization when
infected with COVID-19 (CDC, October 18, 2021--Demographic Trends,
Cases by Age; Total Hospitalizations, by Age). Those who are
hospitalized frequently need supplemental oxygen and treatment for the
disease's most common complications, which include pneumonia,
respiratory failure, acute respiratory distress syndrome (ARDS), acute
kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots.
One study, which included 35,502 inpatients nationwide, determined that
the median length of hospital stay was 6 days, unless the cases
required ICU treatment. For those cases, ICU stays were on median 5
days in addition to the time spent hospitalized outside of the ICU
(Rosenthal et al., December 10, 2020). Another study that assessed
hospital length of stay for COVID-19 patients in England estimated that
a non-ICU hospital stay averaged between 8 and 9 days, but those
estimates ranged from approximately 12 to 18 days when patients were
admitted to the ICU (Vekaria et al., July 22, 2021). Moreover, given
that SARS-CoV-2 is still a novel virus, the severity of long-term
health effects--such as ``post-COVID conditions''--are not yet fully
understood.
Many members of the workforce are at increased risk of death and
severe disease from COVID-19 because of their age or pre-existing
health conditions. The comorbidities that further exacerbate COVID-19
infections are common among adults of working age in the U.S. For
instance, 46.1% of individuals with cancer are in the 20-64 year old
age range (NCI, April 29, 2015), and over 40% of working age adults are
obese (Hales et al., February 2020). Disease severity is also likely
exacerbated by long-standing healthcare inequities experienced by
members of many racial and economic demographics (CDC, April 19, 2021).
Recent data suggests that Delta variant infections may result in
even more severe illness and a higher frequency of death than previous
COVID-19 variants due to Delta's increased transmissibility, virulence,
and immune escape (Fisman and Tuite, July 12, 2021). Symptomatic Delta
variant infections do occur in fully vaccinated people (Mlcochova et
al., June 22, 2021; Musser et al., July 22, 2021); however, as reported
by the CDC (CDC, August 26, 2021), the vast majority of the continuing
instances of severe and fatal COVID-19 infections are occurring in
unvaccinated persons (discussed further in Grave Danger, Section
III.A.IV. Vaccines Effectively Reduce Severe Outcomes from and
Transmission of SARS-CoV-2). An assessment of Delta-related hospital
admissions in Scotland found that hospitalizations were approximately
doubled in patients with the Delta variant when compared to the Alpha
variant (Sheikh et al., June 4, 2021). A similar study conducted using
a retrospective cohort in Ontario, Canada compared the virulence of
novel SARS-CoV-2 variants and found that the incidences of
hospitalization, ICU admission, and death were more pronounced with the
Delta variant than any other SARS-CoV-2 variant (Fisman and Tuite, July
12, 2021). A large national cohort study that included all Alpha and
Delta SARS-CoV-2 patients in England between March 29 and May 23, 2021
found a ``higher hospital admission or emergency care attendance risk
for patients with COVID-19 infected with the Delta variant compared
with the Alpha variant,'' suggesting that Delta outbreaks--especially
amongst unvaccinated populations--may lead to more severe health
consequences and an equivalent or greater burden on healthcare services
than the Alpha variant (Twohig et al., August 27, 2021). However, one
more recent study examining data from several U.S. states demonstrated
a significant increase in hospitalization from the pre-Delta to the
Delta period, which may be related to increased transmissibility of
Delta rather than
more severe health outcomes (Taylor et al., October 22, 2021).
III. Impact on the Workplace
SARS-CoV-2 is readily transmissible in workplaces because they are
areas where multiple people come into contact with one another, often
for extended periods of time. When employees report to their workplace,
they may regularly come into contact with co-workers, the public,
delivery people, patients, and any other people who enter the
workplace. Workplace factors that exacerbate the risk of transmission
of SARS-CoV-2 include working in indoor settings, working in poorly-
ventilated areas, and spending hours in close proximity with others.
Full-time employees typically spend 8 hours or more at work each shift,
more time than they spend anywhere else but where they live. Employees
work in proximity to others in workplaces that were not originally
designed to keep people six feet away from other people and that may
make it difficult for employees to perform work tasks while maintaining
a six-foot distance from others. Even in the cases where workers can do
most of their work from, for example, a private office within a
workplace, they share common areas like hallways, restrooms, lunch
rooms and meeting rooms. Furthermore, many work areas are poorly
ventilated (Allen and Ibrahim, May 25, 2021; Lewis, March 30, 2021). An
additional factor that exacerbates the risk of transmission of SARS-
CoV-2 is interacting with or caring for people with suspected or
confirmed COVID-19; this was a primary driver of OSHA's determination
of grave danger for healthcare workers in the Healthcare ETS (see 86 FR
32381-32383). In recent weeks, the majority of states in the U.S. have
experienced what CDC defines as ``high or substantial community
transmission,'' indicating that there is a clear risk of the virus
being introduced into and circulating in workplaces (CDC, October 18,
2021--Community Transmission Rates).
Although COVID-19 is not exclusively an occupational disease, it is
evident from research accrued since the beginning of the pandemic that
SARS-CoV-2 transmission can and does occur in workplaces, affecting
employees and their lives, health, and livelihoods. This continues to
be true for the Delta variant, with its increased transmissibility and
potentially more severe health effects. This section describes some of
the clusters, outbreaks, and other occurrences of workplace COVID-19
cases that government agencies, researchers, and journalists have
described, and the widespread effects of SARS-CoV-2 in industry sectors
across the national economy. While the focus is on more recent data
reflecting the impact of the Delta variant, evidence of workplace
transmission that occurred prior to the emergence of the Delta variant
is also presented.
The workplace-based clusters described below provide evidence that
workplaces in a wide range of industries have been affected by COVID-
19, that many employees face exposure to infected people in their
workspaces, and that SARS-CoV-2 transmission is occurring in the
workplace, including during the recent period where the Delta variant
has predominated. Although the presence of a cluster on its own does
not necessarily establish that the cluster is work-related (i.e., a
result of transmission at the worksite), many state investigation
reports and published studies provide evidence that transmission is
work related by documenting that infections at a workplace occurred
within 14-days (the incubation period for the virus) of each other and
ruling out the possibility that transmission occurred outside the
workplace. In addition, the information below demonstrates that
exposures to SARS-CoV-2 happen regularly in a wide variety of different
types of workplaces.
The basis for OSHA's grave danger finding is that employees can be
exposed to the virus in almost any work setting; that exposure to SARS-
CoV-2 can lead to infection (CDC, September 21, 2021); and that
infection in turn can cause death or serious impairment of health,
especially in those who are unvaccinated (see Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2). The information described in this section
supports OSHA's finding that employees who work in spaces shared by
others are at risk of exposure to SARS-CoV-2. The degree of risk from
droplet-based transmission may vary based on the duration of close
proximity to a person infected with SARS-CoV-2, including the Delta
variant, but the simple and brief act of sneezing, coughing, talking,
or even breathing can significantly increase the risk of transmission
if controls are not in place. SARS-CoV-2, including the Delta variant,
might also be spread through airborne particles under certain
conditions, particularly in enclosed settings with inadequate
ventilation, which are common characteristics of some workplaces.
The peer-reviewed scientific journal articles, government reports,
and news articles described below establish the widespread prevalence
of COVID-19 among employees, beginning with a description of the recent
impact from the Delta variant. OSHA's findings are based primarily on
the evidence from peer-reviewed scientific journal articles and
government reports. However, peer review for scientific journal
articles and the assembly of information for government reports and
other official sources of information take time, and therefore those
sources do not always reflect the most up-to-date information (Chan et
al., December 14, 2010). In addition, while state and local health
departments can report workplace outbreaks to CDC, the agency does not
provide summary statistics by workplace so that those outbreaks can be
tracked on a national level. In the context of the COVID-19 pandemic,
given the recent impacts due to the Delta variant and the emergence of
new information on a daily basis, it is critical for OSHA to rely on
the most up-to-date information available. Therefore, OSHA has
occasionally supplemented peer-reviewed data and government reports
with additional information on occupational outbreaks contained in
other sources of media (e.g., newspapers, digital media, and
information submitted to or obtained by private organizations).\10\ The
reported information from other sources can provide further evidence of
the impact of an emerging and changing disease, especially for
industries that are not well represented in the peer-reviewed
scientific literature. Together, these sources of information represent
the best available evidence of the impact on employees of the pandemic
thus far.
---------------------------------------------------------------------------
\10\ OSHA did not make findings based solely on non-peer-
reviewed sources such as news articles, but the agency found that
those sources can sometimes provide useful information when
considered with more robust sources.
---------------------------------------------------------------------------
The information described herein illustrates a significant number
of infections among employees in a variety of industries, with
virtually every state continuing to experience what CDC defines as high
or substantial community transmission related to the recent surge of
the Delta variant. The industries and types of workplaces described are
not the only ones in which a grave danger exists. The science of
transmission does not vary by industry or by type of workplace. OSHA
therefore expects transmission to occur in diverse workplaces all
across the country (see Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor,
486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines
a substance poses a grave
danger to workers, OSHA can assume an exposure to a grave danger exists
wherever that substance is present in a workplace)). In addition, the
severity of COVID-19 does not depend on where an employee is infected;
an employee exposed to SARS-CoV-2 might die whether exposed while
working at a meat packing facility, a retail establishment, or an
office (see Grave Danger, Section III.A.V.b. Employees Who Work
Exclusively Outside, below, for a discussion of the risk of exposure in
outdoor workplaces).
a. General Impact on Workers
Data on SARS-CoV-2 infections, illnesses, and deaths among
employees in general industry, agriculture, construction, and maritime
support OSHA's finding that COVID-19 poses a grave danger to employees
in these sectors across the U.S. economy. This section summarizes
studies and reports of COVID-19 illness and fatalities in a wide range
of workplaces across those industry sectors. Not all workplace settings
are discussed; nor is the data available to do so. However, the
characteristics of the various affected workplaces--such as indoor work
settings; contact with coworkers, clients, or members of the public;
and sharing space with others for prolonged periods of time--indicate
that exposures to SARS-CoV-2 are occurring in a wide variety of work
settings across all industries. Therefore, most employees who work in
the presence of other people (e.g., co-workers, customers, visitors)
need to be protected.
While there is no comprehensive source of nationwide workplace
infection data, reports from states and communities on outbreaks
related to workplaces provide key, up-to-date data that illustrate the
likelihood of employee exposure to SARS-CoV-2 at workplaces throughout
the U.S. OSHA identified a number of recent reports from various
regions of the country that together demonstrate the impact that SARS-
CoV-2 can have on a variety of workplaces, including in service
industries (e.g., restaurants, grocery and other retail stores, fitness
centers, hospitality, casinos, salons), corrections, warehousing,
childcare, schools, offices, homeless shelters, transportation, mail/
shipping/delivery services, cleaning services, emergency services/
response, waste management, construction, agriculture, food packaging/
processing, and healthcare. Deaths are reported in many studies
performed prior to the emergence of the Delta variant but, because the
Delta outbreak is so recent and deaths can occur weeks after infection,
the number of deaths from recent infections might be underestimated.
Some of the reports include cumulative data representing various phases
of the pandemic, beginning prior to the availability of vaccines and
continuing through the recent surge of the Delta variant. In addition,
some studies report investigations of recent outbreaks, which provide
insight on the impact of the Delta variant as well as impacts
associated with the current vaccination status of workers.
The Washington State Department of Health (WSDH) reports outbreaks
occurring in non-healthcare workplaces (WSDH, September 8, 2021). In
non-healthcare workplaces, outbreaks are defined as two or more
laboratory confirmed cases of COVID-19, with at least two cases
reporting symptom onset within 14 days of each other, and plausible
epidemiological evidence of transmission in a shared location other
than a household. As of September 4, 2021, WSDH reported 5,247
outbreaks in approximately 40 different types of non-healthcare work
settings. During the week of August 29 through September 4, 2021, WSDH
identified 137 separate workplace outbreaks. The types of non-medical
workplace settings that represented more than 5% of the total outbreaks
during that week included food service/restaurants, childcare, schools,
retail, grocery, and shelter/homeless services. Other types of non-
healthcare settings where outbreaks occurred recently included non-food
and food manufacturing, construction, professional services/office
based, agriculture/produce packing, transportation/shipping delivery,
government agencies/facilities, leisure hospitality/recreation,
corrections, utilities, warehousing, facility/domestic cleaning
services, youth sports/activities, camps, and public safety. Over the
course of the pandemic, outbreaks have also been observed at bars/
nightclubs, hotels, and fishing/commercial seafood vessels.
The Oregon Health Authority (OHA) publishes a weekly report
detailing outbreaks directly related to work settings. OHA
epidemiologists consider cases to be part of a workplace outbreak when
clusters form with respect to space and time, within a plausible
incubation period for the virus, and their investigation does not
uncover an alternative source for the outbreak. For privacy reasons,
OHA only reports outbreaks with 5 or more cases in workplaces with 30
or more people. OHA reported a total of 26,013 cases and 135 deaths
related to workplace outbreaks as of September 1, 2021. As of September
1, 2021, OHA was investigating more than 124 active workplace outbreaks
(OHA, September 1, 2021). Those outbreaks occurred in a wide variety of
industries including correctional facilities, emergency services, waste
management, schools and child care, retail and grocery stores,
restaurants, warehousing, agriculture, food processing/packaging,
construction, healthcare, mail and delivery services, office locations,
utilities, transportation, and others.
Tennessee Department of Health was investigating 557 active COVID-
19 clusters as of September 8, 2021 (TDH, September 8, 2021). Clusters
are defined as two or more laboratory confirmed COVID-19 cases linked
to the same location or event that is not a household exposure. The
clusters occurred in 13 types of settings, 10 of which were workplace
settings. Outbreaks at workplaces represented more than half of the
total active outbreaks in the state at that time. Settings comprising
more than 5% of total clusters included assisted care living
facilities, nursing homes, and correctional facilities. Other types of
workplaces where outbreaks occurred included bars, construction, farms,
homeless shelters, and industrial settings.
The North Carolina Department of Health and Human Services reports
cumulative numbers of clusters, cases, and deaths for workers in
poultry processing facilities (beginning in April of 2020) and other
types of workplaces (beginning in May of 2020) (NCDHHS, August 30,
2021). Clusters are defined as a minimum of 5 cases with illness onset
or initial positive results within a 14-day period and plausible
epidemiological linkage between the cases. Plausible epidemiological
linkage means that multiple cases were in the same general setting
during the same time period (e.g., same shift, same physical area) and
that a more likely source of exposure is not identified (e.g.,
household contact or close contact to a confirmed case in another
setting). During that time period of April/May 2020 through August 30,
2021, workplaces \11\ were associated with nearly 80% of the 1,969
clusters and 27,097 cases observed and nearly 40% of the 167 deaths
related to the clusters. Cumulative numbers of cluster-associated
deaths were highest in meat and poultry processing (25 of 5,351 cases),
followed by healthcare (10 of 1,036 cases), government services and
manufacturing (5 of 1,048 cases and 5 of
1,856 cases, respectively), and restaurants and childcare (3 of 421
cases and 3 of 1,943 cases, respectively). Recently, in July of 2021,
the number of cases associated with workplace clusters began increasing
in several different types of work settings, including meat processing,
manufacturing, retail, restaurants, childcare, schools, and higher
education.
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\11\ NCDHHS identifies a ``workplace'' category in their report
(e.g., agriculture, construction), but OSHA includes other settings
where employees would be present (e.g., retail, restaurants,
childcare, healthcare).
---------------------------------------------------------------------------
Colorado Department of Public Health & Environment/Colorado State
Emergency Operations Center (CDPHE/CSEOC, September 8, 2021) reported
5,584 resolved workplace-related outbreaks involving 40,156 employee
cases and 79 employee deaths since May of 2020. The agency's current
investigations, as of September 8, 2021 included 291 active outbreaks
(not defined), with 2,865 staff cases (assumed to be cases in
employees). The majority of active outbreaks were reported in
childcare, schools, healthcare, and corrections. Active outbreaks were
also reported in construction, retail, homeless shelters, casinos,
restaurants, hotels, offices, law enforcement, manufacturing, delivery
services, and warehouses. Other types of work settings that were
affected in resolved outbreaks included warehouses, bars, government
locations, waste management, utilities, salons, emergency services,
meat processing/packaging, and postal services. From June 21, 2021 (the
date the healthcare ETS was published) through September 8, 2021, 1,469
staff cases associated with outbreaks were reported, for an average of
approximately 19 cases per day.
Similar reporting is available from Louisiana's Department of
Health (LDH, August 24, 2021), with 1,347 outbreaks and 9,130 cases
reported as of August 24, 2021. LDH defines an outbreak as 2 or more
cases among unrelated individuals who visited a site within a 14-day
period. More than three quarters of outbreaks through that date were
associated with workplaces. Workplace settings in Louisiana that
experienced more than 5% of outbreaks included day care facilities,
bars, restaurants, retail settings, industrial settings, and office
spaces. Other types of workplace settings or industries where outbreaks
occurred included casinos, gyms/fitness centers, banks, automotive
services, construction, and ships/boats.
In addition to the state data above, some published studies and
government reports provide information on recent workplaces outbreaks.
For example, 47 people, including 3 of 11 staff members, 23 gymnasts,
and 21 household contacts, contracted COVID-19 from an outbreak linked
to an Oklahoma gymnastics facility during April 15 through May 3, 2021
(Dougherty et al., July 16, 2021). All 21 of the virus samples
sequenced were determined to be the Delta variant. The majority of the
infected individuals (85%) were unvaccinated. Infections were reported
in 16 adults aged 20 years or older; two adults were hospitalized and
one required intensive care.
The state of Hawaii defines clusters as three or more confirmed or
probable cases linked to a site or event within 14 days, with no
outside exposure of cases to each other (Hawaii State, August 19,
2021). The state reported a COVID-19 cluster in July associated with a
concert at a bar that affected 16 people, including employees, band
members, and concert attendees; infections also spread to 7 household
members. Band members had performed while sick. Four of the initial 16
people and none of the household members who tested positive for COVID-
19 were fully vaccinated. The concert cluster was linked to clusters at
another workplace and another concert. The report lists additional
clusters investigated in the two weeks prior to the report; those
clusters were observed in workplace locations such as correctional
facilities, bars and nightclubs, restaurants, construction/industrial
sites, travel/lodging/tourism, schools, food suppliers, and gyms.
Additional evidence that employees are at risk of exposure to SARS-
CoV-2 in the workplace is available from published, peer-reviewed
studies that were conducted before the Delta variant emerged. Those
studies demonstrate that employees have been at risk of infection,
illness, and death throughout the COVID-19 pandemic. Because the Delta
variant is more transmissible and likely causes more severe disease
than previous variants, there is even greater potential for
unvaccinated employees to become seriously ill or die as a result of
exposure to the Delta variant.
Contreras et al. (July, 2021) examined workplace outbreaks
(excluding healthcare settings, homelessness services, and emergency
medical services) in Los Angeles county from March 19 through September
30, 2020. Workplace outbreaks were defined as 5 or more suspected or
laboratory confirmed COVID-19 cases (prior to May 29) or 3 or more
laboratory confirmed cases (after May 29) occurring within 14 days.
Nearly 60% of the 698 identified outbreaks occurred in three sectors--
manufacturing (184, 26.4%), retail trade (137, 19.6%), and
transportation and warehousing (73, 10.5%). Also notable were the 71
outbreaks in the accommodation and food services industry, which
represented 10.2% of the outbreaks. The study authors concluded that
outbreaks were larger and lasted longer at facilities with more onsite
staff.
Outbreaks in Wisconsin from March 4 through November 16, 2020 were
also examined (Pray et al., January 29, 2021). Non-household outbreaks
were defined as two or more confirmed COVID-19 cases that occurred
within 14 days in persons who attended the same facility or event and
did not share a household. During the period from March 4 through
November 16, 2020, the largest percentages of cases were associated
with outbreaks in long-term care facilities (26.8% of cases),
correctional facilities (14.9% of cases), and colleges or universities
(15% of cases). Also notable were the substantial number of cases
associated with outbreaks in food production or manufacturing
facilities (including meat processing and warehousing; 14.5% of cases)
and schools and childcare facilities (10.6% of cases).
Bui et al. (August 17, 2020) analyzed data from the Utah Department
of Health's COVID-19 case surveillance system, which included data on
workplace outbreaks. Outbreaks were defined as two or more laboratory
confirmed cases occurring within a 14 day period among coworkers in a
common workplace (e.g., same facility). During the time period between
March 6 and June 5, 2020, 277 COVID-19 outbreaks were reported, of
which 210 (76%) occurred in workplaces. The 210 workplace outbreaks
occurred in 15 of 20 industry sectors, and the industry sectors of
manufacturing (43 outbreaks, 20%), construction (32 outbreaks, 15%),
and wholesale trade (29 outbreaks, 14%) together represented nearly
half of workplace outbreaks. Other sectors that represented more than
10% of total outbreaks were retail trade (28 outbreaks, 13%) and
accommodation and food services (25 outbreaks, 12%). Incidence rates of
COVID-19 over the period of March 6 through June 5, 2020 were 339/
100,000 workers in manufacturing, 122/100,000 workers in construction,
377/100,000 workers in wholesale trade, 68/100,000 workers for retail
trade, and 78/100,000 workers for accommodation and food services. For
COVID-19 cases associated with workplace outbreaks in which
hospitalization and severity status were known (1,382 and 1,155,
respectively), the number in all sectors who were admitted to the
hospital was 85 (6%) and the number with severe outcomes (intensive
care unit admission, mechanical ventilation, or death) was 40 (3%).
The impact of SARS-CoV-2 exposures on employee infection, illness,
and death has also been demonstrated in studies focusing on specific
types of industries, such as those where employees have frequent
contact with each other and the public (e.g., grocery stores, bars,
fitness facilities, schools, and law enforcement/corrections). For
example, a study by Lan et al. (September 26, 2020) demonstrates the
risk of infection in service industries. The cross-sectional study
examined the risks of SARS-CoV-2 exposure and infection for employees
in a Boston, Massachusetts-area retail grocery store market. The study
tested 104 grocery store employees, of whom 20% (21 employees) were
positive for COVID-19; 76% of confirmed cases did not have symptoms.
After adjusting for gender, smoking, age, and the prevalence of COVID-
19 in the employees' residential communities, employees who had direct
customer exposure (e.g., cashiers, sales associates, cart attendants)
were 5.1 times more likely to have a positive test for COVID-19 than
employees without direct face-to-face customer exposure (e.g.,
stockers, backroom, receiving and maintenance). The infection rate of
20% among all employees was significantly higher than the rate in the
surrounding community.
In February of 2021, an event at an Illinois bar that accommodates
approximately 100 people resulted in a COVID-19 outbreak that affected
46 people, including 3 (10%) staff members, 26 (90%) patrons, and 17
secondary cases (Sami et al., April 9, 2021). People at the event
included an asymptomatic person diagnosed with COVID-19 on the previous
day and 4 symptomatic people who were later diagnosed with COVID-19.
The outbreak resulted in a school closure and the hospitalization of a
resident at a long-term care facility.
In Minnesota, 47 COVID-19 outbreaks were detected at fitness
facilities from August through November of 2020 (Suhs et al., July 23,
2021). One outbreak at a fitness facility during October through
November of 2020 resulted in 23 COVID-19 cases including 5 (22%)
employees and 18 (78%) members. A genetic analysis of specimens from 3
employees and 10 members identified 2 distinct genetic subclusters,
indicating two distinct chains of transmission among members and
employees.
School-related outbreaks were examined from December 1, 2020
through January 22, 2021 in eight public elementary schools of a
Georgia school district (Gold et al., February 26, 2021). A COVID-19
case was determined to be school-related if (1) symptom onset or a
positive test was consistent with the incubation period of the virus
following contact with an index case or a school-associated case, (2)
close contact occurred with the index case or school-associated case
while that person was infected, and (3) no known contact occurred with
an infected community or household contact in the two weeks prior to a
positive test for COVID-19. The investigators identified nine clusters
of three or more epidemiologically linked COVID-19 cases that involved
13 educators and 32 students in six of the eight elementary schools.
Approximately half of the school-associated cases involved two clusters
that began with probable transmission between educators, followed by
educator to student transmission. Eighteen of 69 household members
tested received positive results.
A number of studies demonstrate the impact of COVID-19 in law
enforcement and related fields such as corrections. For example, a
study examining COVID-19 antibodies in employees from public service
agencies in the New York City area from May through July of 2020, found
that 22.5% of participants had COVID-19 antibodies (Sami et al., March,
2021). The percentage of correctional officers found to have COVID-19
antibodies (39.2%) was the highest observed among all the occupations.
The percentages of police dispatchers, traffic officers, security
guards, and dispatchers found to have COVID-19 antibodies (29.8 to
37.3%) were among the highest levels observed in all the occupations.
The study authors noted that those jobs involve frequent or close
contact with the public or are done in places where employees work in
close proximity to their coworkers.
Wallace et al. (May 15, 2020) evaluated data on COVID-19 cases and
deaths among correctional facility employees and inmates from January
21 to April 21, 2020. Data were reported to CDC by 37 (69%) of 54 state
and territorial health department jurisdictions. Of these 37
jurisdictions, 32 (86%) reported at least one COVID-19 case from a
correctional facility. Of the 420 facilities with a case, 221 (53%)
reported cases only among staff members. In total, 4,893 COVID-19 cases
among incarcerated or detained persons and 2,778 cases among staff
members were reported (total tested not provided). Among staff member
cases, 79 hospitalizations (3%) and 15 deaths (1%) were reported. The
study authors noted that ``correctional and detention facilities face
challenges in controlling the spread of infectious diseases because of
crowded, shared environments and potential introductions by staff
members and new intakes.''
Ward et al. (June 2021) analyzed COVID-19 prevalence among
prisoners and staff in 45 states from March 31, 2020 through November
4, 2020. During that time period, COVID-19 cases in staff were 3 to 5
times higher compared to the U.S. population. Average daily increases
in cases were 42 per 100,000 prison employees, 61 per 100,000
prisoners, and 13 per 100,000 U.S. residents. On November 4, 2020,
COVID-19 prevalence for prison staff was 9,316 cases per 100,000
employees, which was 3.2 times greater than prevalence in the U.S.
population (2,900 cases per 100,000).
Kirbiyik et al. (November 6, 2020) analyzed movement through a
network-informed approach to identify likely high points of
transmission within the Cook County Jail in Chicago, IL. At that
facility, over 900 COVID-19 cases were reported across 10 housing
divisions in 13 buildings from March 1-April 30, 2020. Staff members
were required to report symptoms of COVID-19 (probable cases) or
receipt of a positive test result (confirmed cases). A total of 2,041
staff members (77% of staff) were included in the network analysis
because information was available about their shift and division
assignments, and 198 (9.7%) of those staff members had COVID-19 during
the two-month study period. Connections between staff members who had
COVID-19 were higher than expected, suggesting likely transmission
among staff members. Fewer connections than expected were observed
among detained persons with SARS-CoV-2 infections, suggesting the
effectiveness of medical isolation at reducing transmission.
The Officer Down Memorial Page, which tracks police officer
fatalities determined to be occupationally related, reported that the
majority of officer deaths for 2021 (157 of 269) were related to COVID-
19 (ODMP, September 14, 2021). For the 269 officers who died, causes of
death were not reported for each month, but the highest numbers of
monthly deaths, 52 in January and 65 in August (compared to 16 to 34
deaths on other reported months), were consistent with the winter surge
of COVID-19 and, more recently, the surge caused by the Delta variant.
The risk of COVID-19 has also been examined in industries where
employees have little contact with the public, such as construction,
and food processing, and where most exposure to
SARS-CoV-2 likely comes from other workers. Pasco et al. (October 29,
2020) examined the association between construction work during the
COVID-19 pandemic and community transmission and construction worker
hospitalization rates in Austin, Texas from March 13 to August 20,
2020. A ``Stay Home-Work Safe'' order enacted on March 24, 2020,
limited construction to only critical infrastructure and excluded
commercial and residential work. One week later, the Texas governor
lifted the restriction for essential workers and allowed all types of
construction work to resume, while keeping the order in place for other
workers. The authors found that resuming construction during the
shelter-in-place order led to an increase in community transmission, an
increase in hospitalizations among community members, and an increase
in hospitalizations of construction workers. By mid-July, Austin Public
Health identified at least 42 clusters (not defined) of COVID-19 cases
in the construction industry; 515 individuals were hospitalized for
COVID-19 illnesses acquired as part of these clusters, and 77 of those
reported working in construction. The study found that construction
workers had a nearly 5-fold increased risk of hospitalization in
central Texas compared with workers in other occupations. The authors'
model predicted that allowing unrestricted construction work would be
associated with an increase in COVID-19 hospitalization rates from 0.38
per 1,000 residents to 1.5 per 1,000 residents overall, and from 0.22
per 1,000 construction workers to 9.3 per 1,000 construction workers
for the construction industry specifically. The authors concluded that
stringent workplace safety measures could significantly mitigate risks
related to COVID-19 in the industry.
The meat packing and processing industries and related agricultural
and food processing sectors have also been impacted by COVID-19.
Waltenburg et al. (January, 2021) reported COVID-19 cases in employees
from meat and poultry processing facilities in 31 states from March 1
through May 31, 2020. As reported in Table 2 of that report, 28,364
employees in those facilities were confirmed to have COVID-19 by
laboratory testing and 132 died. Among the 20 states that reported
total numbers of employees, 11.4% of the workers were diagnosed with
COVID-19 (with a range of 3.1 to 27.7% of workers in individual
states). For states that reported at least one COVID-19-related death,
the percentages of employees who died in each state ranged from 0.1 to
2.4% of those with COVID-19. The authors found a high burden of disease
in persons employed at these facilities who were racial or ethnic
minorities. Higher incidence in these populations might be due to the
likelihood of these employees working in areas in the plant where
transmission risk is higher. Steinberg et al. (August 7, 2020) reported
that attack rates (i.e., the number of individuals who are infected in
comparison to the total number at risk) among production employees in
the Cut (30.2%), Conversion (30.1%), and Harvest (29.4%) departments of
a meat processing plant (where spacing between employees is less than 6
feet) were double that of salaried employees (14.8%) whose workstations
had been modified to increase physical distancing from others.
Waltenburg et al. (January, 2021) also evaluated COVID-19 incidence
in food manufacturing and agricultural settings (e.g., manufacturing or
farming involving fruits, vegetables, dairy, baked goods, eggs,
prepared foods), as reported in 30 states from March through May 2020.
In food manufacturing and farming of fruits, vegetables, dairy, and
other items, 742 workplaces were affected, including 8,978 infections
and 55 fatalities. For states that reported total numbers of employees,
the proportion of employees who developed COVID-19 in each state ranged
from 2.0 to 43.5%. For states that reported at least one death, the
percentages of deaths among cases ranged from 0.1 to 3.8%.
Porter et al. (April 30, 2021) reported that 13 COVID-19 outbreaks
occurred at Alaska seafood processing facilities and vessels (both of
which were described as high density workplaces) during the Summer and
early Fall of 2020. The 13 outbreaks involved 539 COVID-19 cases, with
2-168 cases per outbreak. Attack rates in facilities and offshore
vessels ranged from less than 5% to 75%. Outbreaks were also reported
in entry quarantine groups. Because of these outbreaks, it was
determined that vaccination of these essential workers is important and
requirements for COVID-19 prevention were updated to include smaller
quarantine groups, serial testing, and testing before transfers from
one facility or vessel to another.
Finally, two published studies analyzed death records to determine
how mortality rates among individuals in various types of workplaces
had changed during the pandemic. Chen et al. (June 4, 2021) analyzed
records of deaths occurring on or after January 1, 2016 in California
and found that mortality rates in working aged adults (18-65 years)
increased 22% during the COVID-19 pandemic period of March through
November 2020 compared to pre-pandemic periods. Relative to pre-
pandemic periods, the groups of employees experiencing the highest,
statistically significant increases in relative excess mortality were
those in food/agriculture (39% increase), transportation/logistics (31%
increase), facilities (23% increase), and manufacturing (24% increase).
Other groups that also experienced excess, statistically significant
mortality compared to pre-pandemic periods were health or emergency
workers (17% increase), retail workers (21% increase), and government
and community workers (17% increase). The study authors concluded that
certain occupational sectors were impacted disproportionally by
mortality during the pandemic and that essential work conducted in-
person is a likely avenue of infection transmission.
Hawkins et al. (January 10, 2021) examined death certificates of
individuals who died in Massachusetts between March 1 and July 31,
2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was
determined from 555 death certificates that had useable occupation
information. Employees in 11 occupational groups had particularly high
mortality rates: healthcare support; transportation and material
moving; food preparation and serving; building and grounds cleaning and
maintenance; production, construction and extraction; installation/
maintenance/repair; protective services; personal care services; arts/
design/entertainment; sports/media; and community and social services.
The study authors noted that occupational groups expected to have
frequent contact with sick people, close contact with the public, and
jobs that are not practical to do from home had particularly elevated
mortality rates.
b. Healthcare Workers
As explained in the Healthcare ETS, COVID-19 presents a grave
danger to workers in all U.S. healthcare settings where people with
COVID-19 are reasonably expected to be present (86 FR 32381).
Healthcare settings covered by the Healthcare ETS primarily include
settings where people with suspected or confirmed COVID-19 are treated,
exacerbating the risk present in most workplaces. To control the higher
level of risk in those settings, OSHA determined that a suite of
workplace controls was necessary to protect all employees, whether they
are vaccinated or unvaccinated. As explained further
below, OSHA now finds that unvaccinated healthcare workers in
healthcare settings not covered by the Healthcare ETS are also at grave
danger from exposure to SARS-CoV-2, just like unvaccinated workers in
other industries. Data continue to be collected and reported for
healthcare workers, and a small number of peer-reviewed studies
demonstrate the potential impact of the Delta variant on healthcare
workers.
CDC continues to provide updates for COVID-19 cases and deaths
among healthcare personnel. However, information on healthcare
personnel status continues to be reported for only a fraction (18.91%)
of total reported cases, and death status was reported for only 82.16%
of healthcare personnel cases as of October 18, 2021 (CDC, October 18,
2021--Healthcare Personnel). Given incomplete reporting, the data from
this source represent only a fraction of actual healthcare cases and
deaths. Nevertheless, CDC reported 666,707 healthcare personnel cases
among the 6,754,306 reported cases that included information on
healthcare personnel status (9.9%) and 2,229 fatalities among the
547,769 cases that included death status (0.4%) for healthcare
employees as of October 18, 2021. This is a 26% increase in the number
of cases and a 27% increase in the number of deaths since the May 24,
2021 data reported in the ETS (CDC, October 18, 2021--Healthcare
Personnel). The Delta variant is likely responsible for the majority of
those deaths. No healthcare worker deaths were reported by CDC during
the weeks of May 30 through June 13, 2021; however, as the Delta
variant's prevalence rose after June 20, healthcare worker deaths began
increasing; they peaked during the period of August 15 through
September 12, 2021, when 34 to 36 healthcare worker deaths were
reported per week (CDC October 18, 2021--Healthcare Personnel, Deaths
by Week). Independent reporting by Kaiser Health News and The Guardian
reported more than 3,600 fatalities in health care workers as of April
2021 (Spencer and Jewett, April 8, 2021). That number is expected to be
higher at this time since the earlier figure did not include the most
recent 5 months of the pandemic, which includes the period of Delta
variant predominance.
Published studies also demonstrate that healthcare workers,
especially those who are unvaccinated, remain at risk of being infected
with SARS-CoV-2 (see Section III.A.IV. Vaccines Effectively Reduce
Severe Health Outcomes from and Transmission of SARS-CoV-2). Routine
testing of health care personnel, first responders, and other frontline
workers in eight U.S. locations in six states from December 14, 2020
through August 14, 2021 revealed 194 infections in 4,136 unvaccinated
participants (89.7% symptomatic) and 34 infections in 2,976 fully
vaccinated participants (80.6% symptomatic) (Fowlkes et al., August 27,
2021). During time periods when the Delta variant represented more than
50% of viruses sequenced, 19 infections were detected in 488
unvaccinated participants (94.7% symptomatic) and 24 infections were
detected in 2,352 vaccinated participants (75% symptomatic).
Monthly COVID-19 cases in healthcare workers were reported during
the period from March 1 to July 31, 2021 at the University of
California San Diego (UCSD) health system, which is a healthcare
provider that includes primary care services such as family medicine
and pediatrics (Keehner et al., September 1, 2021; UCSD, 2021). During
that time period, a total of 227 health care workers tested positive
for COVID-19. One hundred and nine of 130 fully vaccinated workers who
tested positive (83.8%) were symptomatic and 80 of 90 unvaccinated
workers (88.9%) were symptomatic; one unvaccinated person was
hospitalized for COVID-19 symptoms. By July of 2021, after the end of
California's mask mandate on June 15 and after the Delta variant became
dominant, the number of cases detected dramatically increased; the
Delta variant accounted for more than 95% of SARS-CoV-2 viruses
sequenced by the end of that month. During July of 2021, symptomatic
infections were detected in 94 of 16,492 fully vaccinated workers and
31 of 1,895 unvaccinated workers. Attack rates in July of 2021 were 5.7
per 1,000 fully vaccinated workers and 16.4 per 1,000 unvaccinated
workers.
In Finland, a Delta variant infection from a hospitalized patient
spread throughout the hospital and to three primary care facilities,
infecting 103 individuals, including 45 healthcare workers
(Hetem[auml]ki et al., July 29, 2021). Twenty-six of the healthcare
workers were infected at the hospital and 19 were infected at primary
care facilities. The affected health care workers included 28 with
direct patient contact (11 who were not fully vaccinated), 8
unvaccinated healthcare worker students, and 9 other staff, including
hospital cleaners and secretaries (of whom 6 were not fully
vaccinated). According to study authors, ``There was high vaccine
coverage among permanent staff in the central hospital, but lower for
HCW in primary healthcare facilities. . .'' Study authors estimated
that vaccine effectiveness against the Delta variant in healthcare
workers was approximately 88-91%, suggesting how much more extensive
the outbreak could have been if a high percentage of healthcare workers
were not fully vaccinated.
In the UK, a Delta variant infection in a healthcare worker
resulted in an outbreak in a care home that affected 16 of 21 residents
and 8 of 21 staff (Williams et al., July 8, 2021). One staff member was
hospitalized. Attack rates were 35.7% in staff who were partially
vaccinated (i.e., received their second dose of vaccine on the day that
the index case was diagnosed with COVID-19 or had only received one
vaccine dose) and 40% in staff who were not vaccinated.
Recent news stories demonstrate that outbreaks affecting staff
members are still occurring in U.S. healthcare facilities. An outbreak
that began in August, 2021 at a Washington State nursing center
resulted in infections in 22 staff members and 52 residents. In an
unrelated outbreak, a nursing facility in Hawaii reported infections in
24 employees and 54 patients (Wingate, September 24, 2021). Vaccination
rates were reported at 64.5% of residents and 37.1% of staff in the
Washington State facility and 91% of staff and more than 80% of
patients at the Hawaii facility.
COVID-19 cases were also observed in staff at ambulatory care
settings prior to emergence of the Delta variant. Over an 11-week
period beginning on March 20, 2020, 254 tests for SARS-CoV-2 were
performed on employees who had potential exposures at an outpatient
urology center in New York State (Kapoor et al., 2020). Positive test
rates in employees correlated with rates in New York State, declining
over time, from 26.1% in the early stage to 7.3% in the late stage of
the study. According to study authors, the positive test results
coincided with the implementation of infection control procedures
(e.g., symptom screening, masking, distancing, and hygiene). Positivity
rates were similar in administrative and clinical staff and the study
authors concluded that ``administrative staff in an outpatient setting
were equally--if not more--vulnerable to SARS-CoV-2 transmission when
compared with clinical staff who were more directly exposed to
patients.'' The study authors speculated that possible reasons for the
findings were that clinical staff were more familiar with PPE and that
administrative staff, especially in check-in and check-out points, tend
to work close to each other.
c. Conclusion for Employee Impact
The evidence described above provides examples of the impact that
exposures from SARS-CoV-2, including those involving the Delta variant,
have had on employees in general industry, agriculture, construction,
maritime, and healthcare settings. It demonstrates that SARS-CoV-2 has
spread to employees in these industries and, in many cases, infection
was linked to exposure to infected persons at the worksite (WSDH,
September 8, 2021; OHA, September 1, 2021; TDH, September 8, 2021;
NCDHHS, August 30, 2021; Hawaii State, August 19, 2021; Pray et al.,
January 29, 2021; Sami et al., April 9, 2021; Suhs et al., July 23,
2021; Gold et al., February 26, 2021; Porter et al., April 30, 2021;
Hetem[auml]ki et al., July 29, 2021; Williams et al., July 8, 2021).
The documentation of so many workplace clusters suggests that exposures
to SARS-CoV-2 occur regularly in workplaces where employees come into
contact with others. This prevalence of clusters, combined with some
evidence that many infections occurred within the 14-day incubation
period for SARS-CoV-2 and that exposures to infected persons outside
the workplace were frequently ruled out, supports the proposition that
exposures to and transmission of SARS-CoV-2 occur frequently at work.
Multiple studies demonstrate high rates of COVID infections, illnesses,
and fatalities in the wide range of occupations that require frequent
or prolonged close contact with other people, indoor work, and work in
crowded and/or poorly ventilated areas The large numbers of infected
employees suggest that SARS-CoV-2 is likely to be present in a wide
variety of workplaces, placing unvaccinated workers at risk of serious
and potentially fatal health effects.
IV. Vaccines Effectively Reduce Severe Health Outcomes From and
Transmission of SARS-CoV-2
During the course of the SARS-CoV-2 pandemic, different variants
have emerged with different characteristics that better enable
transmission and potentially cause more severe outcomes. However,
vaccines remain very effective at reducing the occurrence of COVID-19-
related severe illness, disability and death.\12\ The Delta variant is
more transmissible than previous variants, might cause more severe
illness than previous variants in unvaccinated people, and has led to
hospitalization of individuals in numbers similar to those of the
November 2020 to February 2021 surge. These changes in characteristics
have provided a clearer realization of the continuing capacity for
SARS-CoV-2 to present a grave danger to workers. However, it is well
evident that even given these changed characteristics of Delta, serious
disease and death continue to occur overwhelmingly in unvaccinated
individuals while the vaccinated are afforded great protection.\13\
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\12\ A discussion of vaccination rates, as well as OSHA's
rationale for why vaccination is a critical means of protecting
workers from the grave danger described in this section, can be
found in Need for the ETS (Section III.B. of this preamble).
\13\ While mild cases of COVID-19 are included in the grave
danger presented by COVID-19, as stated in the Healthcare ETS (see
86 FR 32382), OSHA is focusing on the most severe health effects,
i.e., cases requiring hospitalization and cases resulting in death,
in this new rulemaking effort in order to prevent the gravest of
consequences to workers.
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a. Impact of Vaccination on Severe Health Outcomes
There are currently three vaccines that are approved or authorized
for the prevention of COVID-19 in the U.S.: The Pfizer-BioNTech COVID-
19 vaccine (FDA approved for ages 16 and above; authorized for ages 12
and above), the FDA-authorized Moderna COVID-19 vaccine (authorized for
ages 18 and above), and the FDA-authorized Janssen COVID-19 vaccine
(also known as the Johnson & Johnson vaccine; authorized for ages 18
and above.) Pfizer-BioNTech and Moderna are mRNA vaccines that require
two primary series doses administered three weeks and one month apart,
respectively. Janssen is a viral vector vaccine administered as a
single primary vaccination dose (CDC, September 15, 2021). The vaccines
were shown to greatly exceed minimum efficacy thresholds in preventing
COVID-19 in clinical trial participants (FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26, 2021). Data from clinical trials
for all three vaccines and observational studies for the two mRNA
vaccines clearly establish that fully vaccinated persons have a greatly
reduced risk of SARS-CoV-2 infection compared to unvaccinated
individuals. This includes severe infections requiring hospitalization
and those resulting in death. For more information about the
effectiveness of vaccines as of late Spring 2021, see 86 FR 32397,
which OSHA hereby includes in the record for this ETS.\14\
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\14\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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Vaccines remain highly effective against hospitalization and death.
A study evaluating vaccine effectiveness at preventing hospitalization
among those with SARS-CoV-2 infections in New York found that
effectiveness did not change from May 3 to July 25, 2021 as the Alpha
variant gave way to the Delta variant (91.9-96.2% range; Rosenberg et
al., August 27, 2021). Grannis et al. used data from 187 hospitals in
nine states from June to August 2021 to evaluate the efficacy of
vaccines against hospitalization when Delta had emerged as the
predominant variant causing SARS-CoV-2 infections (September 17, 2021).
This study found that vaccines were 89% effective at preventing
hospitalization in individuals aged 18 to 74. Similarly, vaccines were
also found to be 89% effective in preventing hospitalization in a study
collecting data from five Veteran Affairs Medical Centers from July 1
to August 6, 2021, a time when most transmission was attributed to the
Delta variant (Bajema et al., September 10, 2021).
Two other studies found that, although the level of protection
provided by vaccination has decreased somewhat with the emergence of
the Delta variant, vaccines continue to provide high levels of
protection against hospitalization. In a U.S. study, researchers found
that while the Moderna and Janssen vaccines mostly maintained their
effectiveness at preventing hospitalization (going from 93% to 92%
after more than 120 days post-vaccination and 71% to 68% after more
than 28 days post-vaccination, respectively) from March to August 2021,
the effectiveness of the Pfizer-BioNTech vaccine at preventing those
severe outcomes decreased from 91% to 77% after more than 120 days
post-vaccination (Self et al., September 17, 2021). An Israeli study on
infections documented between July 11 and July 31, 2021 found a
significant decrease in vaccine efficacy for the Pfizer-BioNTech
vaccine against severe outcomes in relation to when an individual was
vaccinated, but the absolute difference was much less than what was
observed in the U.S. study (e.g., 98% effective for 40-59 year olds
vaccinated in March versus 94% effective for those in the same age
group who were vaccinated in January) (Goldberg et al., August 30,
2021).
Vaccines also remain extremely effective at preventing death. A UK
study evaluated the effectiveness of the Pfizer-BioNTech vaccine
against death and found it to be 96.3% effective against the Alpha
strain and 95.2% protective against the Delta strain (Andrews et al.,
September 21, 2021). Two Israeli studies, Haas et al. and Saciuk et
al., performed during time periods where Alpha was predominant, found
the Pfizer-BioNTech vaccine to be 96.7% and 91.1% effective,
respectively, against death (Haas et al., May 15, 2021; Saciuk et al.,
June 25, 2021). A California study found that the Moderna vaccine was
97.9% effective against death (Bruxvoort et al., September 2, 2021). A
study on patients served by the Veterans Health Administration found
that Pfizer-BioNTech and Moderna vaccines provided 99% effectiveness
against death (Young-Xu et al., July 14, 2021).
The risks of hospitalization and death appear to have increased for
unvaccinated individuals since the Delta variant became a common source
of infections. A study of Los Angeles County SARS-CoV-2 infections
found that vaccinations reduced hospitalization risk by a factor of 10
on May 1, 2021, when the Alpha variant was dominant, but that the risk
of hospitalization was even more greatly reduced (by a factor of 29.2)
on July 25, 2021, when the Delta variant was dominant (Griffin et al.,
August 27, 2021). This difference suggests both that vaccines continue
to provide a high level of protection against disease that results in
hospitalization and that risk has increased for those who are
unvaccinated. Similar increased risk for unvaccinated individuals was
reported in a study that evaluated hospitalization and death data from
13 U.S. jurisdictions between June 20 and July 17, 2021, a period when
the Delta variant gained prominence (Scobie et al., September 17,
2021). For unvaccinated 18 to 49 year olds, the risk of hospitalization
was 15.2 times greater, and the risk of death was 17.2 times greater,
than the risks for vaccinated people in the same age range. For
unvaccinated 50 to 64 year olds, the risk of hospitalization was 10.9
times greater, and the risk of death was 17.9 times greater, than for
those who are vaccinated. These studies illustrate that vaccination is
an extremely effective control measure to minimize severe outcomes
resulting from Delta variant infections.
b. Impact of Vaccination on Infection and Transmission
Vaccines continue to provide robust protection for vaccinated
individuals against SARS-CoV-2 infections, even though several studies
indicate that vaccine efficacy against infection may have decreased
somewhat with the emergence of the Delta variant (Fowlkes et al.,
August 27, 2021; Rosenberg et al., August 27, 2021; Nanduri et al.,
August 27, 2021; Seppala et al., September 2, 2021; Bernal et al.,
August 12, 2021). For example, vaccination was observed to reduce the
risk of infection by a factor of 8.4 on May 1, 2021, when the Alpha
variant was predominant in Los Angeles county (Griffin et al., August
27, 2021). However, the level of protection had fallen to a factor of
4.9 by July 25, 2021, when Delta made up 88% of infections in the
county. The findings from this study indicate that while vaccines
maintain robust protection against severe outcomes, protection against
infection has fallen with the increased circulation of the Delta
variant. A broader study using data from 13 U.S. jurisdictions had
similar findings, observing that the protection vaccines afforded
against infection decreased from a factor of 11.1 (i.e., vaccinated
people were 11.1 times less likely than unvaccinated people to become
infected) between April 4 and June 19, 2021, to a factor of 4.6 between
June 20 and July 17, 2021 (Scobie et al., September 17, 2021). An
additional study noted, however, that the decrease in vaccine
protectiveness against symptomatic infection from the Delta variant
could be due to the waning of immunity specifically in older
populations. Andrews et al. (September 21, 2021) found that while the
Pfizer-BioNTech vaccine effectiveness decreased from 94.1% to 67.4% in
those 65 years old and older, vaccine effectiveness for those 40 to 64
years old only decreased from 92.9% to 80.6%.
While infections themselves do not normally result in serious
illness for those who are vaccinated, evidence shows that vaccinated
individuals who become infected with the Delta variant can transmit the
disease more easily to others than with previous variants. This
development poses a great concern for the unvaccinated, who generally
do not have the protections against severe outcomes that vaccination
affords. Before Delta, vaccinated individuals were shown to have lower
estimated viral loads when infected than those who were unvaccinated,
which suggested that infected vaccinated individuals were likely not a
major concern for transmission (Levine-Tiefenbrun et al., March 29,
2021). Transmission studies prior to the emergence of Delta appear to
bear this out. A Scottish study performed during a time period when the
Alpha variant was predominant in the region, showed that a fully
vaccinated individual was 3.2 times less likely than an unvaccinated
individual to transmit the virus to unvaccinated family members (Shah
et al., September 10, 2021; supplementary appendix). A population-based
study from the Netherlands found that vaccination decreased secondary
transmission to household members from 31% to 11% (de Gier et al.,
August 5, 2021). Additionally, a study from the UK found that household
transmission decreased by as much as 50% when the infected individual
was vaccinated (Harris et al., June 23, 2021).
More recent research suggests that the Delta variant may have
reduced the level of protection vaccination affords against
transmission of the virus to others, but still significantly reduces
transmission risk in comparison to infected unvaccinated individuals. A
UK study found that fully vaccinated individuals infected by the Delta
variant are able to transmit the virus to both vaccinated and, to a
greater degree, unvaccinated persons (Singanayagam et al., September 6,
2021). Still, the rate at which transmission to unvaccinated
individuals occurred was nearly double the rate of transmission to
vaccinated individuals (35.7% compared to 19.7%). Similarly, Eyre et
al., (September 29, 2021) found that during the predominance of Alpha,
full vaccination with the Pfizer-BioNTech vaccines resulted in a
significant reduction in transmission to others (an adjusted Odds Ratio
(aOR) of 0.18, meaning that being unvaccinated increased the odds of
transmission by over five times). With the rise of the Delta variant,
that reduction in transmission to others was less than with the Alpha
variant, but still significantly more than for unvaccinated individuals
(aOR of 0.35, meaning that being unvaccinated increased the odds of
transmission by almost three times).
The greater ability for vaccinated individuals to transmit the
Delta variant of SARS-CoV-2 to others (compared to previous variants)
appears to be linked to the generation of similar viral loads (as
estimated by Ct threshold) in the vaccinated compared to the
unvaccinated (Ct threshold is the number of RT-PCR cycles that need to
be run in order to amplify the RNA enough to be detected--fewer cycles
means a greater initial amount of virus was collected) (Singanayagam et
al., September 6, 2021). This observation has been made in several
studies. A study from Israel observed that viral loads among those
infected with the Delta variant were only decreased in people who had
been vaccinated recently (within the past two months) or in those who
had recently received a booster dose (Levine-Tiefenbrun et al.,
September 1, 2021). In a study of SARS-CoV-2 infections in Los Angeles
County, performed when the Delta variant was predominant, vaccination
status did not appear to affect the estimated viral loads, suggesting
that infected individuals who are vaccinated
may be just as likely to transmit the virus (Griffin et al., August 27,
2021). Additionally, estimated viral loads did not appear to be
significantly different with respect to vaccination status in a
Wisconsin study (Riemersma et al., July 31, 2021). Regardless of viral
loads in vaccinated and unvaccinated individuals, the fact remains
clear that unvaccinated people pose a higher risk of transmission to
others than vaccinated people, simply because they are much more likely
to get COVID-19 in the first place.
These studies, however, appear to overstate increases in
transmission risk from vaccinated individuals related to the Delta
variant. From May to July 2021, UK researchers tested individuals at
random to better characterize viral load estimates in people with
asymptomatic as well as symptomatic infections; they found that
vaccination was associated with a significantly lower estimated viral
load (Elliott et al., September 10, 2021). This more comprehensive
study (i.e., Elliott et al., September 10, 2021) may have been able to
better characterize the course of infection and to incorporate
vaccinated individuals whose viral loads were decreasing quickly. The
findings in Elliott et al. are consistent with studies observing that
viral load may fall more quickly in vaccinated individuals, resulting
in a shorter infectious period and possibly fewer transmission events
(Chia et al., July 31, 2021; Eyre et al., September 29, 2021).
c. Conclusion for the Impact of Vaccines
The studies discussed above indicate that vaccines continue to
effectively protect vaccinated individuals against SARS-CoV-2
infections, while the risk of infection, hospitalization, and death
increased among unvaccinated people as the Delta variant became
predominant in the U.S. The Delta variant is even more dangerous to
unvaccinated individuals than previous variants because of the higher
transmission potential from both unvaccinated and vaccinated people.
Because unvaccinated individuals are at much higher risk of severe
health outcomes from infection with SARS-CoV-2, and also pose a greater
transmission risk to those around them, it is critical to assure that
as many people as possible are fully vaccinated in order to prevent
transmission at work.
V. Coverage of OSHA's Grave Danger Finding
Based on the information discussed above, OSHA finds that many
unvaccinated workers across the U.S. economy are facing a grave danger
of severe health effects or death from exposure to SARS-CoV-2. Fully
vaccinated workers are not included in this grave danger finding
because, as described throughout this section, those who are fully
vaccinated are much better protected from the effects of SARS-CoV-2
and, in particular, the most severe effects, than are those who are
unvaccinated.\15\ Beyond that, OSHA's grave danger determination
exempts several categories of workers based on characteristics of their
work or workplace: (1) Workers who do not report to a workplace where
other individuals are present or who telework from home; and (2)
workers who perform their work exclusively outdoors. The basis for
these exemptions is explained below. In this section, OSHA also
addresses the basis for OSHA's grave danger finding for workers who are
unvaccinated yet had a prior COVID-19 infection, and explains the
Agency's more nuanced grave danger finding in the healthcare industry.
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\15\ The exclusion of vaccinated workers from this grave danger
finding does not mean that vaccinated workers face no risk from
exposure to SARS-CoV-2. The best available evidence clearly shows
that vaccination provides great protection from infection and severe
outcomes, but breakthrough infections do occur and vaccinated
individuals can still transmit the virus to others. In some cases,
the level of risk to vaccinated workers may even rise to the level
of a significant risk, the standard OSHA must meet for promulgation
of a permanent standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)).
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a. Employees Who Telework and Employees Who Do Not Report to a
Workplace Where Other People Are Present.
Employees who report to workplaces where no other people are
present face no grave danger from occupational exposure to COVID-19
because such exposure requires the presence of other people. For those
who work from their homes, or from workplaces where no other people are
present (such as a remote worksite), the chances of being exposed to
SARS-CoV-2 through a work activity are negligible. Therefore, OSHA is
exempting those workers who do not come into contact with others for
work purposes from its grave danger finding as well as the scope of the
ETS (for more information, see the Summary and Explanation for Scope
and Application, Section VI.B. of this preamble).
b. Employees Who Work Exclusively Outside
Employees who work exclusively outside face a much lower risk of
exposure to SARS-CoV-2 at work, because their workplaces typically do
not include any of the characteristics that normally enable
transmission to occur (e.g., indoors, lack of ventilation, crowding).
Bulfone et al. attributed the lower risk of transmission in outdoor
settings (i.e., open air or structures with one wall) to increased
ventilation with fresh air and a greater ability to maintain physical
distancing (November 29, 2020). While the best available evidence
firmly establishes a grave danger in indoor settings, the CDC has
stated that the risk of outdoor transmission is ``low'' (CDC, September
1, 2021) and OSHA is unable to establish a grave danger in outdoor
settings from exposure during normal work activities.
OSHA recognizes that outdoor transmission has been identified in a
few specific incidents (e.g., 2 of 7,324 cases, Qian et al., October
27, 2020). However, general reviews of transmission studies that
include large-scale and high-density outdoor gatherings indicate that
indoor transmission overwhelmingly is responsible for SARS-CoV-2
transmission. Additionally, the lack of evidence tied to specific case
studies illustrating outdoor transmission in comparison to the bevy of
case studies on indoor transmission makes it difficult to support a
conclusion that outdoor transmission rises to the level of a grave
danger.
Bulfone et al. reviewed a collection of SARS-CoV-2 studies that
evaluated infections in outdoor and indoor settings (November 29,
2020), and found that transmission is significantly less likely to
occur in outdoor settings than in indoor settings. The studies overall
found that the risk of outdoor transmission was less than 10% of the
risk of transmission in indoor settings, with three of the studies
concluding risk was 5% or less of the risk of transmission in indoor
settings. While acknowledging significant gaps in knowledge, the
authors of a different study suggested that increases in transmission
related to large events such as the Sturgis motorcycle rally may be
related to lack of local efforts to prevent transmission indoors (e.g.,
requiring the wearing of masks, closing indoor dining), rather than the
outdoor setting for the rally (Dave et al., December 2, 2020). In
contrast, transmission rates did not increase as expected following the
Summer 2020 protests on racial injustice. This outcome was attributed,
in part, to participants having been less likely to enter indoor
commercial establishments.
Weed and Foad (September 10, 2020) found that transmission of SARS-
CoV-2 related to large scale outdoor gatherings could be largely
attributed to individual behaviors related to that event, such as
communal travel and indoor congregation at other facilities (e.g.,
restaurants, shared accommodations), rather than to the time spent
outdoors at those gatherings. Similarly, a Public Health England
evaluation of the literature on SARS-CoV-2 and surrogate respiratory
viruses (December 18, 2020) also concluded that when transmission does
occur at outdoor events, outdoor activities were mixed with indoor
setting use. Public Health England concluded that the vast majority of
transmission happens in indoor settings, with very little evidence for
outdoor transmission.
A systemic review of SARS-CoV-2 clusters identified 201 events
through May 26, 2020 (Leclerc et al., April 28, 2021), only 4 of which
occurred at predominantly outdoor settings. For those 4 clusters, the
authors noted that they were not able to evaluate specific transmission
events and attributed it to local health agencies being overwhelmed by
the pandemic. OSHA notes that the designations of settings in this
study are somewhat generic, as outdoor construction sites will often
have indoor locations, such as mobile offices, or locations with
reduced airflow, such as areas with a roof or ceiling and two or more
walls. Regardless, this study illustrates the comparable abundance of
evidence available to evaluate SARS-CoV-2 transmission in indoor
settings versus outdoor settings.
Cevik et al. (August 1, 2021) reviewed studies on the transmission
dynamics of SARS-CoV-2 infections from large scale, contact-tracing
studies. The authors recommended that, based on the evidence that
outdoor transmission dynamics resulted in significantly fewer
infections than in indoor settings, public health entities should
greatly encourage use of outdoor settings. The researchers highlighted
a study by Nishiura et al. (April 16, 2020), who evaluated 110 cases in
Japan at the beginning of the pandemic and found that outdoor settings
reduced transmission risk by 18.7 times and reduced the risk of super-
spreader events by 32.5 times.
Agricultural workplace settings have experienced significant SARS-
CoV-2 infections. However, transmission in these settings is difficult
to characterize because many jobs in this sector include both outdoor
and indoor activities. Miller et al. (April 30, 2021) evaluated an
outbreak among farmworkers in Washington State. The researchers found
that 28% of workers with predominantly indoor tasks where they were
unable to maintain physical distance were infected, compared to 6% of
workers who performed predominantly outdoors tasks in the orchards.
Conversely, a study on farmworkers in Monterey County, California found
a significant correlation between evidence of infection and individuals
who worked in the fields as opposed to indoor work (Mora et al.,
September 15, 2021). The paper noted that infections were predominant
in individuals who lived in crowded conditions, commuted together to
the fields, and spoke at home in indigenous languages, which is
important as written health messages are often not available in all
worker languages. These papers cannot identify where or when infections
occurred in order to discern causation. The associations observed may
indicate that SARS-CoV-2 infections may be more related to aspects
related to indoor exposures outside of the work activities (e.g.,
crowded living conditions) or potentially overlooked indoor aspects
connected to outdoor work (e.g., shared commuting).
Several studies discussed below in more detail have evaluated
outdoors on-field transmission from infected participants during
football, soccer, and rugby matches. These events include repeated
close physical contact between players, without PPE or physical
distancing, over the course of fairly long events, with increased
exertion leading to greater respiratory effort and production of
respiratory droplets. These events also include opposing cohorts who
only interact during on-field activities. Therefore, these studies
provide some evidence for the low likelihood of outdoor transmission in
other workplace activities greatly impacted by the pandemic, such as in
construction.
Mack et al. (January 29, 2021) detailed the National Football
League's complex program to assess and prevent transmission, which
included devices that recorded distance and duration of interactions
with others, for the purpose of improving identification of individuals
with high-risk exposures. Although 329 positive cases were identified
among roughly 11,400 players and staff, there were no reported cases of
on-field transmission by infected players. The results led the NFL to
focus more on reducing transmission in indoor settings, including
transportation.
Egger et al. (March 18, 2021) reviewed three soccer matches
involving 18 players who had SARS-CoV-2; one match involved a team
where 44% of the players were infected. Video analysis was used to
determine the type of contact between players, such as contact to face
or hand slaps. None of the existing cases were associated with on-field
play and no secondary transmission from on-the-field contacts was
observed. Jones et al. (February 11, 2021), evaluated four rugby Super
League matches involving eight players who were found to be infected
with SARS-CoV-2. Using video footage and global positioning data, the
researchers were able to identify 28 players as high-risk contacts with
the infected players. These high-risk players together had as many as
32 tackles and were within two meters of infected players as often as
121 times during the four matches. Of the 28 players noted as high-risk
contacts, one became infected with SARS-CoV-2. However, researchers
determined that the transmission resulted from internal team outbreaks
and not from exposure on the field.
OSHA acknowledges that the risk of transmission of SARS-CoV-2 in
outdoor settings is not zero, and that there may be some low risk to
workers performing general tasks exclusively in outdoor settings.
However, where studies have been able to differentiate between indoor
and outdoor exposures, they indicate that indoor exposures are the much
more significant drivers of SARS-CoV-2 infections. Therefore, the best
available evidence at this time does not provide OSHA with the
information needed to establish SARS-CoV-2 as a grave danger for
general work activities in outdoor settings (see Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW, 590 F. Supp. at
755-56, describing a ``grave danger'' as a risk that is more than
``significant''). Therefore, OSHA has excluded employees who work
exclusively outdoors from the scope of this ETS (see the Summary and
Explanation for Scope and Application, Section VI.B. of this preamble).
c. Employees in Healthcare
Because OSHA issued a separate grave danger determination several
months ago for some healthcare workers, some explanation of how its
current finding applies to healthcare workers is necessary. In June
2021, OSHA issued its Healthcare ETS (86 FR 32376) after determining
that some healthcare workers faced a grave danger of infection from
SARS-CoV-2. This grave danger determination, along with the protections
of the Healthcare ETS, applied to healthcare and healthcare support
workers in settings where
people with suspected or confirmed cases of COVID-19 are treated, and
was based on the increased potential for transmission of the virus in
such settings (see 86 FR 32411-32412). These workers are currently
covered by the protections of the Healthcare ETS (29 CFR 1910.502).
OSHA does not have data to demonstrate that unvaccinated workers in
settings covered by the Healthcare ETS face a grave danger from SARS-
CoV-2 when the requirements of that standard are followed. However, if
the Healthcare ETS were no longer in effect, OSHA would consider the
workers who were covered by it, and who remain unvaccinated, to be at
grave danger for the reasons described in this ETS.
OSHA's new finding of grave danger applies to healthcare and
healthcare support workers who are not covered by the Healthcare ETS,
to the extent they remain unvaccinated. In this ETS, as discussed in
this section, OSHA has made a broader determination of grave danger
that applies to most unvaccinated workers, regardless of industry.
OSHA's current finding of grave danger supporting this ETS does not
depend on whether a workplace is one where people with suspected or
confirmed COVID-19 are expected to be present. Therefore, the finding
of grave danger applies to unvaccinated workers in healthcare settings
that are not covered by 29 CFR 1910.502 to the same extent it applies
to unvaccinated workers in all other industry sectors.
d. Employees Who Were Previously Infected With SARS-CoV-2
OSHA has carefully evaluated the effectiveness of previous SARS-
CoV-2 infections in providing protection against reinfection. This
section provides a detailed description of the current scientific
information in order to ascertain what the best available scientific
evidence on this topic indicates regarding the risk to individuals with
previous COVID-19 infections from exposure to SARS-CoV-2. While the
agency acknowledges that the science is evolving, OSHA finds that there
is insufficient evidence to allow the agency to consider infection-
acquired immunity to allay the grave danger of exposure to, and
reinfection from, SARS-CoV-2.
To determine whether employees with infection-induced immunity from
SARS-CoV-2 (i.e., those who were infected with SARS-CoV-2 but have not
been vaccinated) face a grave danger, OSHA reviewed the scientific
evidence on the protective effects of vaccine-induced SARS-CoV-2
immunity versus infection-induced immunity. Individual immunity to any
infectious disease, including SARS-CoV-2, is achieved through a complex
response to exposure by the immune system. This response consists of
disease-specific antibody production guided and augmented by certain
types of immune cells, such as T and B cells, which work together to
neutralize or destroy the disease-causing agent. Immune responses to
viruses like SARS-CoV-2 can be measured in several ways. For instance,
blood serum can be taken and exposed to specific proteins found on the
SARS-CoV-2 virus, in order to measure the presence of antibodies in the
blood. Another antibody test, the neutralization test, measures the
ability of the antibodies present in a serum to neutralize infectivity
and prevent cells from being infected. T cell immunity can be measured
using techniques that target a specific biomolecule that is specific to
SARS-CoV-2.
A considerable number of individuals who were previously infected
with SARS-CoV-2 do not appear to have acquired effective immunity to
the virus (Psichogiou et al., September 13, 2021; Wei et al., July 5,
2021; Cavanaugh et al., August 13, 2021). The level of protection
afforded by infection-induced immunity appears to depend on the
severity of individuals' infections. In a study from Greece,
immunogenicity was compared between healthcare workers who were
vaccinated with Pfizer-BioNTech and unvaccinated patients who acquired
a natural infection (Psichogiou et al., September 13, 2021). The
researchers found that the immune response in unvaccinated individuals
correlated to the severity of their disease. Fully vaccinated
healthcare workers had immune responses (measured as antibody levels
specific to SARS-CoV-2) that were 1.3 times greater than patients who
had critical cases of COVID-19 cases, 2.5 times greater than patients
who had moderate to severe cases, and 10.5 times greater than patients
who had asymptomatic/mild illnesses. Similarly, another study found
that 24.0% (1,742 of 7,256) of individuals who had a previous SARS-CoV-
2 infection were seronegative (i.e., did not produce antibodies in
response to the virus), suggesting that the previous infection provided
insufficient protection against future infection (Wei et al., July 5,
2021). Individuals who were seronegative were typically older, had
lower viral burdens when infected, and were more likely to be
asymptomatic. The authors posited that the immunity of those who were
seropositive (i.e., did produce antibodies in response to the virus)
would provide some measure of protection, but that these individuals
would benefit from a vaccination booster. This position appears to be
validated by a study that compared the reinfection rates of individuals
in Kentucky based on their post-recovery vaccination status (Cavanaugh
et al., August 13, 2021). Unvaccinated individuals with previous
infection were found to be 2.3 times more likely to be reinfected than
those who were vaccinated after their prior infection. These studies
demonstrate not only that those with milder infections may not be
protected against future infection, but that it is difficult to tell,
on an individual level, which individuals might have had prior
infections that conveyed protection equivalent to that provided by
vaccination.
A number of other studies indicate that fully vaccinated
individuals may be better protected against future infection than those
with previous infections. A study in Massachusetts concluded that the
immunity conveyed from a previous SARS-CoV-2 infection was effectively
equivalent to the immunity of an uninfected individual who has had only
one dose of an mRNA vaccine (Naranbhai et al., October 13, 2021). The
authors found that fully vaccinated individuals have an immune response
(i.e., antibodies and neutralization) well above the levels observed in
unvaccinated, previously-infected individuals. German researchers found
that individuals who were fully vaccinated with Pfizer-BioNTech had a
significantly greater immune response (as measured by antibody levels)
than unvaccinated individuals who had infections, concluding that
vaccination would be needed for those unvaccinated individuals to have
similar protection against infection (Herzberg et al., June 13, 2021).
Similarly, a Dutch study observed that vaccination greatly improved the
immune response (as measured by antibodies and virus-specific T cells)
of individuals who had recovered from COVID-19 (Geers et al., May 25,
2021). Planas et al. (August 12, 2021) also noted that immune response
(as measured by neutralization) to the Alpha, Beta, and Delta
(B.1.617.2) variants in unvaccinated, previously-infected individuals
was considerably less than the immune response in individuals five
weeks after their second Pfizer-BioNTech dose. When unvaccinated,
previously-infected individuals were vaccinated, their immune response
(as measured by neutralization) increased by more than an order of
magnitude. Likewise, Wang
et al. (July 15, 2021) found that the immune response (as measured by
neutralization) of those with previous SARS-CoV-2 infection increased
by more than an order of magnitude against Alpha (B.1.1.7), Beta
(B.1.351), Iota (B.1.526), and Gamma (P.1) variants when they were
vaccinated. These studies show that infection-induced immunity may not
equal the protection afforded by vaccination and that vaccination
greatly improves the immune response of those who were previously
infected.
The aforementioned studies indicate that immunity acquired through
infection appears to be less protective than vaccination. There are
also a number of epidemiological studies that provide some evidence
that infection-acquired immunity has the potential to provide a
significant level of protection against reinfection. As OSHA discusses
in greater detail below, these studies suffer from methodological
limitations that render them inconclusive about the level of immunity
conferred by infection, and therefore OSHA is unable to establish that
such immunity eliminates grave danger. This determination is based in
three parts.
First, the epidemiological literature OSHA reviewed generally
suffers from selection bias to a degree that it serves as an unreliable
basis on which to reach a robust conclusion on whether previous
infection removes workers from grave danger. In general, the studies
described below do not account for people who had mild COVID-19
infections, leading to study findings regarding the level of protection
afforded by prior infection that are not generally applicable. Second,
the tests employed in the studies are being used in ways that they were
not originally designed to be employed. These tests are powerful tools,
but there are limitations to their use in determining if a specific
individual is, in fact, protected from the grave danger of SARS-CoV-2.
Particularly problematic is the lack of established thresholds to
determine full protection from reinfection or even a standardized
methodology to determine infection severity or immune response. Thus,
while these studies broadly establish some increase in protectiveness
against SARS-CoV-2 among the studied populations, they as yet are
unable to provide a reasonable degree of certainty on whether the
degree of protection afforded any particular individual from their
prior infection is sufficient to eliminate the grave danger from
reinfection (see Milne, et al., October 21, 2021.) Third, while the
research methodology itself creates difficulties in the context of
OSHA's grave danger inquiry, the implications of trying to apply
investigative research methodology to clinical practice are even more
challenging. The need for the development of standardized methods and
criteria for establishing sufficient immunity preclude the application
of the studies' findings to robust and reliable clinical practice.
These three rationales for OSHA's finding are described in more detail
below.
Several epidemiological studies used previous RT-PCR positive cases
to define previous infections (Hansen et al., March 27, 2021; Pilz et
al., February 11, 2021; Vitale et al., May 28, 2021; Pouwels et al.,
October 14, 2021; Braeye et al., September 15, 2021; Hall et al., April
17, 2021). RT-PCR tests, particularly in the beginning of the pandemic,
were given high priority to discern who seeking medical care was, in
fact, infected. For instance, the progression of testing from medical
needs to more of a community perspective is illustrated in Denmark
(Vrangbaek et al., April 29, 2021). Denmark, considered one of the gold
standard countries for its comprehensive testing program, missed five
infections for every one it identified in the spring of 2020 (Espenhaim
et al., August 22, 2021). Hansen et al. (March 27, 2021) depended
greatly on these first surge infection definitions to determine that
survivors had protection of 80.5% effectiveness during the second surge
in Denmark from September through December, 2020. By only noting RT-PCR
positives from the spring when testing was limited and highly focused
on health care needs, it seems apparent that the study excluded many
less severe cases (which are less likely to result in an effective
immune response against reinfection), leading to results that may
suggest greater protection is afforded by infection than in actuality.
Even by December of 2020, it appears Denmark's gold standard
comprehensive testing approach was only able to capture roughly half of
all infections. Similar systemic undercounts have also been determined
to be true in the United States where approximately three out of four
infections have never been reported (CDC, July 27, 2021b).
It is important to recognize that RT-PCR testing was not
implemented to find every infection, but was used instead to assist in
determining when medical and community interventions were necessary.
Infections without symptoms or with mild symptoms likely would not
require medical intervention and, therefore, would likely not be
identified via testing. The absence of this population that is more
vulnerable to reinfection, in these studies, undercuts their usefulness
in OSHA's grave danger analysis, because they may overestimate the
protectiveness of immunity acquired through infection.
Several other studies in regions less known for their sampling
approach than Denmark also were heavily dependent on early, limited
pandemic RT-PCR testing. An Austrian study found a roughly ten-fold
decrease in reinfection in survivors of reported infections from
February to April 30, 2020 in comparison with the general public (Pilz
et al., February 11, 2021). The authors noted that ``infections in the
first wave are likely to have been far more common than the documented
ones'' and referred to their results as a ``rough estimate.''
Researchers at the Cleveland Clinic also found a reduced rate of
reinfection in those who had a reported previous infection compared
with those with no prior infection (13.8% infection rate for those
previously uninfected and 4.9% infection rate for those previously
infected), but noted that testing was limited in that the ``Cleveland
Clinic did not test asymptomatic patients unless they were admitted to
hospital or undergoing a procedure/surgery'' (Sheehan et al., March 15,
2021). These criteria for testing create uncertainty in determining the
level of effectiveness previous infection provides against SARS-CoV-2
because many individuals with asymptomatic infections would not have
been tested. Similar issues are also found in studies on populations in
Italy, Belgium, and the UK (Vitale et al., May 28, 2021; Braeye et al.,
September 15, 2021; Pouwels et al., October 14, 2021).
To avoid the well-known problems with RT-PCRs defining previous
infection, other studies have defined previous infection as testing
positive for antibodies specific for SARS-CoV-2 (Lumley et al.,
February 11, 2021; Abu-Raddad et al., April 28, 2021; Hall et al.,
April 17, 2021). As noted above, previous infection does not
necessarily result in a seropositive outcome; one study indicated that
nearly a quarter (24%) of those infected with SARS-CoV-2 subsequently
showed no sign of an immune response in SARS-CoV-2-specific antibody
testing (Wei et al., July 5, 2021). Therefore, studies only considering
seropositive individuals are in essence studying only the individuals
most likely to have protection from reinfection. Lumley et al.
(February 11, 2021) found that those having a seropositive response had
almost an order of magnitude fewer infections (e.g., 0.11 adjusted
incidence rate ratio). Likewise, Abu-Raddad et al. (April 28,
2021) found that seropositive individuals were reinfected less (0.7%)
during their study period in comparison to seronegative individuals
(3.09%). In addition to the bias associated with using antibodies to
determine previous infection, the authors also noted that there may
have been issues with being able to document cases with mild or no
symptoms.
Hall et al. (April 17, 2021) cast a wider net by defining previous
infection to include both positive RT-PCR tests and seropositivity. The
researchers found that those who were considered previously infected
had an 84% lower risk of infection compared to those who were
unvaccinated with no record of infection. While the study does attempt
to capture as many previously-infected individuals as possible, this
does not actually address the weaknesses of each method. Those with
less severe infections were less likely to have sought out or been able
to get an RT-PCR test during the first surge, which is when an
overwhelming number of the previous infections were recorded in this
study (March through May, 2020). Additionally, the less severe
infections that are most likely underrepresented in the study appear to
be the ones that are less likely to produce seropositivity. Shenai et
al. (September 21, 2021) pooled several studies with the above issues
and concluded that immunity acquired through a previous infection from
SARS-CoV-2 may be as protective as, or more protective than, the
immunity afforded by vaccination to an individual without previous
infection. However, authors of several of those underlying studies used
in the analysis noted that their studies were limited by not having the
capability to fully account for asymptomatic infections (the
aforementioned Lumley et al., July 3, 2021; Gazit et al., August 25,
2021; Shrestha et al., June 19, 2021). As noted earlier, infection
severity appears to be correlated with the robustness of immunity
acquired through that infection, so the failure to account for
asymptomatic infections may mean that this finding is related to the
protection afforded by more severe disease. While pooled analyses can
be utilized to make powerful observations, those observations are
highly dependent upon the underlying studies not sharing the same
methodological weakness which, in this case, was the studies' exclusion
of asymptomatic infections.
Moreover, while the evidence suggests that severe infection may
provide significant protection against reinfection in some cases (Milne
et al., October 21, 2021), the level of protection cannot be determined
on an individual basis. The studies discussed above are based on tests
that show only whether a person was or was not infected and provide no
information about the severity of the infection. Because the studies
are likely biased towards those who had a relatively serious infection,
their findings cannot be generalized to all individuals with prior
infections.
RT-PCR and antibody testing are powerful tools with many clinical
and research applications. However, the application of these tools
cannot determine what degree of protection a particular individual has
against SARS-CoV-2 without a great deal of additional study concerning
thresholds establishing individual immunity. Therefore, these tools are
not yet able to assist OSHA in making more nuanced findings about which
workers who had COVID-19 previously are at grave danger. There is no
established threshold to determine full protection from reinfection or
a standardized methodology to determine infection severity or immune
response. Studies use Ct threshold to approximate viral loads and infer
disease severity, but that metric depends on many variables (e.g. time
of collection during infection, quality of collection, handling of
sample, specifics of the test protocol and materials, precision in
performing the protocol) that are often of far less importance when it
is used as a crude diagnostic to determine the presence of an
infection. In other words, it is reasonable to say that the lower the
Ct count, the greater the likelihood that an individual is at a lower
reinfection risk; however, the Ct count is greatly dependent on the RT-
PCR test used, and how different laboratories may run that test, which
cannot be discerned. Similarly, research needs to be done to better
identify the minimum protective threshold of anti-SARS-CoV-2 serum
neutralizing antibodies (Milne et al., October 21, 2021). Thus, these
studies currently do not allow OSHA to determine, with a reasonable
degree of certainty, how much protection employees with prior
infections have against reinfection.
Furthermore, while the research methodology itself raises
challenges in making the grave danger determination, the implications
of trying to apply investigative research methodology to clinical
practice are even more difficult. The lack of standardized methods and
standardized measures for immunity preclude their application to robust
and reliable clinical practice. One major drawback discussed above is
that, in contrast to vaccine studies where researchers know who was
vaccinated with a standardized dosing regime, scientific inquiries
likely will not be able to identify most individuals who were infected,
the degree of disease experienced for those with a confirmed infection,
and the immunity against reinfection. As of October 18, 2021, several
RT-PCR assays have been authorized without standardization or
assessment with respect to measuring disease severity (FDA, October 18,
2021). As noted above, the use of the Ct threshold to approximate viral
loads and infer disease severity is unreliable. As the FDA notes, the
same is true about antibody tests, which are considered to be poor
indicators for individuals to use to determine whether they are
protected from reinfection (FDA, May 19, 2021). There are many
different SARS-CoV-2-specific antibody tests that focus on different
specificity. Not only are the outcomes of these tests not directly
comparable to each other, but the specificity of these tests is not
related to any notion of protection against reinfection. It can be
reasonably said that a greater antibody response means a greater
likelihood of protection against infection, but, again, the science is
not clear what those thresholds are and whether a threshold would be
comparable between laboratories. At this point in time, even if OSHA
determined that some individuals with prior infections are not at grave
danger from exposure to SARS-CoV-2, there is no agreement on what
indicators of infection might be sufficient to confer this level of
immunity or how a healthcare provider or employer could document that a
certain level of immunity had been achieved.
Based on the best available evidence described above, OSHA
concludes that while some individuals who were infected with SARS-CoV-2
may have significant protection from subsequent infections, the level
of protection afforded by infection may be significantly impacted by
the severity of the infection and some previously infected individuals
may have no future protection at all. In addition, given the
limitations of the studies described above, there is considerable
uncertainty as to whether any given individual is adequately protected
against reinfection. Furthermore, the level of protection, if any,
provided by a given person's SARS-CoV-2 infection cannot be ascertained
based on currently-available testing methods. Therefore, OSHA finds
that the requirements of this ETS are necessary to protect unvaccinated
individuals who had prior SARS-CoV-2 infections from the grave danger
from exposure to SARS-CoV-2.
OSHA recognizes that its finding regarding infection-induced
immunity is being made in an area of inquiry that is currently on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 656 (1980)). For these reasons, OSHA
finds that those who have previously been infected with SARS-CoV-2 and
are not yet fully vaccinated are at grave danger from SARS-CoV-2
exposure and that it is necessary to protect these workers via
vaccination, or testing and the use of face coverings, under this
standard. OSHA will continue to follow developments on this issue,
however, and make appropriate adjustments to this ETS if the evidence
warrants.
VI. Conclusion.
OSHA finds that many employees in the U.S. who are not fully
vaccinated against COVID-19 face a grave danger from exposure to SARS-
CoV-2 in the workplace. OSHA's determination is based on the severe
health consequences of exposure to the virus, including death; powerful
lines of evidence demonstrating the transmissibility of the virus in
the workplace; and the prevalence of infections in employee
populations.
With respect to the grave health consequences of exposure to SARS-
CoV-2, OSHA has found that regardless of where and how exposure occurs,
COVID-19 can result in death. Even for those who survive a SARS-CoV-2
infection, the virus can cause serious, long-lasting, and potentially
permanent health effects. Serious cases of COVID-19 require
hospitalization and dramatic medical interventions, and might leave
employees with permanent and disabling health effects. Both death and
serious cases of COVID-19 requiring hospitalization provide independent
bases for OSHA's finding of grave danger. The evidence is clear that
the safe and effective vaccines authorized and/or approved for use in
the United States greatly reduce the likelihood of these severe
outcomes.
The best available evidence on the science of transmission of the
virus makes clear that SARS-CoV-2 is transmissible from person to
person in shared workplace settings. The likelihood of transmission can
be exacerbated by common characteristics of many workplaces, including
working indoors, working with others for extended periods of time, poor
ventilation, and close contact with potentially infectious individuals.
The likelihood of transmission in the workplace is also exacerbated by
the presence of unvaccinated workers, who are more likely than those
who are vaccinated to be infected and transmit the virus to others.
Every workplace SARS-CoV-2 exposure or transmission has the potential
to cause severe illness or even death, particularly in unvaccinated
workers. Taken together, the severe health consequences of COVID-19 and
the evidence of its transmission in environments characteristic of the
workplaces covered by this ETS demonstrate that exposure to SARS-CoV-2
represents a grave danger to unvaccinated employees in many workplaces
throughout the country.
The existence of a grave danger to employees from SARS-CoV-2 is
further supported by the toll the pandemic has already taken on the
nation as a whole and the number of workers who remain unvaccinated.
Although OSHA cannot state with precision the total number of workers
in our nation who have contracted COVID-19 at work and became sick or
died, COVID-19 has killed 723,205 people in the United States as of
October 18, 2021 (CDC, October 18, 2021--Cumulative US Deaths). That
death toll includes 131,478 people who were 18 to 64 years old, prime
working age (CDC, October 18, 2021--Demographic Trends, Deaths by Age
Group). OSHA estimates that there are over 26 million workers subject
to the rule who remain unvaccinated at present and therefore are in
grave danger. As a result of this ETS, the agency estimates that 72% of
them will be vaccinated (see OSHA, October 2021c).
Current mortality data shows that unvaccinated people of working
age have a 1 in 202 chance of dying when they contract COVID-19 (CDC,
October 18, 2021--Demographic Trends, Cases by Age Group; Demographic
Trends, Deaths by Age Group). As of October 18, 2021, close to 45
million people in the United States have been reported to have
infections, and thousands of new cases were being identified daily
(CDC, October 18, 2021--Daily Cases).One in 14 reported cases of COVID-
19 in people ages 18 to 64 becomes severe and requires hospitalization
(CDC, October 18, 2021--Demographic Trends, Cases by Age; Total
Hospitalizations, by Age). Moreover, public health officials agree that
these numbers fail to show the full extent of the deaths and illnesses
from this disease, and racial and ethnic minority groups are
disproportionately represented among COVID-19 cases, hospitalizations,
and deaths (CDC, December 10, 2020; CDC, May 26, 2021; Escobar et al.,
February 9, 2021; Gross et al., October 2020; McLaren, June 2020; CDC,
October 6, 2021). Given this context, OSHA is confident in its finding
that exposure to SARS-CoV-2 poses a grave danger to the employees
covered by this ETS.
The above analysis fully satisfies the OSH Act's requirements for
finding a grave danger. Although OSHA usually performs a quantitative
risk assessment based on extrapolations among exposure levels before
promulgating a health standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)), that type of analysis is not necessary in this
situation. OSHA has most often invoked section 6(b)(5) authority to
regulate exposures to chemical hazards involving much smaller
populations, many fewer cases, extrapolations from animal evidence,
long-term exposure, and delayed effects. In those situations,
mathematical modelling is necessary to evaluate the extent of the risk
at different exposure levels. The gravity of the danger presented by a
disease with acute effects like COVID-19, on the other hand, is made
obvious by a straightforward count of deaths and illnesses caused by
the disease, which reach sums not seen in at least a century. The
evidence compiled above amply supports OSHA's finding that SARS-CoV-2
presents a grave danger in American workplaces. In the context of
ordinary 6(b) rulemaking, the Supreme Court has said that the OSH Act
is not a ``mathematical straitjacket,'' nor does it require the agency
to support its findings ``with anything approaching scientific
certainty,'' particularly when operating on the ``frontiers of
scientific knowledge'' (Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 655-56 (1980)). This is true a fortiori in the
current national crisis, where OSHA must act to ensure employees are
adequately protected from the hazard presented by the COVID-19 pandemic
(see 29 U.S.C 655(c)(1)).The grave danger from SARS-CoV-2 represents
the biggest threat to employees in OSHA's more than 50-year history.
The threat applies to employees in all sectors covered by OSHA,
including general industry, construction, maritime, agriculture, and
healthcare. Having made the determination of grave danger, as well as
the determination that an ETS is necessary to protect employees from
exposure to SARS-CoV-2 (see Need for the ETS, Section III.B. of this
preamble), OSHA is required to issue this standard to protect employees
from getting sick or dying from COVID-19 acquired at work (see 29
U.S.C. 655(c)(1)).
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B. Need for the ETS
This ETS is necessary to protect unvaccinated workers from the risk
of contracting COVID-19, including its more contagious variants, such
as the B.1.617.2 (Delta), at work. The rule protects workers through
the most effective and efficient workplace control available:
Vaccination. Additionally, this ETS is necessary to protect workers who
remain unvaccinated through required regular testing, use of face
coverings, and removal of infected employees from the workplace.
I. Events Leading to the ETS
This section describes the evolution of OSHA's actions to protect
employees from the grave danger posed by COVID-19 and the agency's
reasons for issuing this ETS at this time.
a. OSHA's 2020 Actions Regarding COVID-19
Beginning in early 2020, OSHA began to monitor the growing cases of
the SARS-CoV-2 virus that were occurring around the country. Because
scientific information about the disease, its potential duration, and
ways to mitigate it were undeveloped, OSHA decided to monitor the
situation. As noted below, OSHA subsequently issued numerous guidance
documents advising interested employers of steps they could take to
mitigate the hazard arising from the virus.
Also beginning in early 2020, OSHA received numerous petitions and
supporting letters from members of Congress, unions, advocacy groups,
and one group of large employers urging the agency to take immediate
action by issuing an ETS to protect employees from exposure to the
virus that causes COVID-19 (Scott and Adams, January 30, 2020; NNU,
March 4, 2020; AFL-CIO, March 6, 2020; Menendez et al., March 9, 2020;
Wellington, March 12, 2020; DeVito, March 12, 2020; Carome, March 13,
2020; SMART, March 30, 2020; Blumenthal et al., April 8, 2020; Murray
et al., April 29, 2020; Luong, April 30, 2020; Novoa, June 24, 2020;
Solt, April 28, 2020; Castro et al., April 29, 2020; Talbott and Adely,
May 4, 2020; Public Citizen, March 13, 2020;
LULAC, March 31, 2020; Meuser, May 1, 2020; Raskin, April 29, 2020;
Cartwright et al., May 7, 2020; Frosh et al., May 12, 2020; Pellerin,
March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020; Brown et
al., April 30, 2020; Price et al., May 1, 2020; ORCHSE, October 9,
2020). These petitions and supporting letters argued that many
employees had been infected because of workplace exposures to the virus
that causes COVID-19, and that immediate, legally enforceable action is
necessary for protection. OSHA quickly began issuing detailed guidance
documents and alerts beginning in March 2020 that helped employers to
determine employee risk levels of COVID-19 exposure and made
recommendations for appropriate controls. As explained in detail in
Section IV. of the Healthcare ETS, 86 FR 32376, 32412-13 (June 21,
2021) and hereby included in the record for this ETS,\16\ at the time,
OSHA leadership believed that implementing a combination of enforcement
tools, including guidance, existing OSHA standards, and the General
Duty Clause, would provide the necessary protection for workers. OSHA
also expressed concern that an ETS might unintentionally enshrine
requirements that are subsequently proven ineffective in reducing
transmission.
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\16\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------
When it decided not to issue an ETS in the spring of 2020, OSHA
determined that the agency could provide sufficient employee protection
against COVID-19 through enforcing existing workplace standards and the
General Duty Clause of the OSH Act, coupled with issuing industry-
specific, non-mandatory guidance. However, in doing so OSHA indicated
that its conclusion that an ETS was not necessary was specific to that
time, and that the agency would continue to monitor the situation and
take additional steps as appropriate (see, e.g., OSHA, March 18, 2020
Letter to Congressman Scott (stating ``[W]e currently see no additional
benefit from an ETS in the current circumstances relating to COVID-19.
OSHA is continuing to monitor this quickly evolving situation and will
take the appropriate steps to protect workers from COVID-19 in
coordination with the overall U.S. government response effort.''
(emphasis supplied); DOL May 29, 2020 at 20 (stating ``OSHA has
determined this steep threshold [of necessity] is not met here, at
least not at this time.'' (emphasis supplied))).
In addition to the various petitions for rulemaking that were
submitted to OSHA, the AFL-CIO filed a petition for a writ of mandamus
with the U.S. Court of Appeals for the D.C. Circuit, requesting that
the court compel OSHA to issue an ETS. (AFL-CIO, May 18, 2020). In its
administrative decision and filing in that case, OSHA explained that
the determination not to issue an ETS was based on the conditions and
information available to the agency at that time and was subject to
change as additional information indicated the need for an ETS. On June
11, 2020, the U.S. Court of Appeals for the D.C. Circuit issued a one
paragraph per curiam order denying the AFL-CIO's petition to require
OSHA to issue an ETS. To be clear, nothing in OSHA's prior position or
the D.C. Circuit's decision in In re Am. Fed'n of Labor & Cong. of
Indus. Orgs., No. 20-1158, 2020 WL 3125324 (D.C. Cir. June 11, 2020);
rehearing en banc denied (July 28, 2020) precludes OSHA's decision to
promulgate an ETS now. To the contrary, at an early phase of the
pandemic, when vaccines were not yet available and when it was not yet
known how extensive the impact would be on illness and death, the court
decided not to second-guess OSHA's decision to hold off on regulation
in order to see if its nonregulatory enforcement tools could be used to
provide adequate protection against the virus. ``OSHA's decision not to
issue an ETS is entitled to considerable deference,'' the court
explained, noting ``the unprecedented nature of the COVID-19 pandemic''
and concluding merely that ``OSHA reasonably determined that an ETS is
not necessary at this time.'' (Id., with emphasis added).
Employers do not have a reliance interest in OSHA's prior decision
not to issue an ETS on May 29, 2020, which did not alter the status quo
or require employers to change their behavior. See Dep't of Homeland
Security v. Regents of the Univ. of California, 140 S. Ct. 1891, 1913-
14 (2020). As OSHA indicated when it made the decision, the
determination was based on the conditions and information available to
the agency at that time and was subject to change as additional
information indicated the need for an ETS. In light of the agency's
express qualifications and the surrounding context, any employer
reliance would have been unjustified and cannot outweigh the
countervailing urgent need to protect workers covered by this ETS from
the grave danger posed by COVID-19.
b. OSHA's Decision To Promulgate a Healthcare ETS
OSHA subsequently issued the Healthcare ETS to protect healthcare
workers. 86 FR 32376. (June 21, 2021), codified at 29 CFR 1910.502.
Looking back on a year of experience, OSHA found that its enforcement
efforts had encountered significant obstacles, demonstrating that
existing standards, regulations, and the General Duty Clause were
inadequate to address the grave danger faced by healthcare employees.
86 FR 32415. In promulgating that ETS, OSHA recognized that ``the
impact of [COVID-19] has been borne disproportionately by the
healthcare and healthcare support workers tasked with caring for those
infected by this disease.'' 86 FR 32377. Furthermore, states and
localities had taken increasingly divergent approaches to workplace
protections against COVID-19, making it clear that a federal standard
was needed to ensure sufficient protection in all states. 86 FR 32377.
Therefore, OSHA focused on the unique situation experienced by
healthcare industry workers as the frontline caregivers and support
workers for those suffering from COVID-19. See 86 FR 32376, 32411-12.
The Healthcare ETS requires employers to institute a suite of
engineering controls, administrative controls, work practices, and
personal protective equipment to combat the COVID-19 hazard. In the
Preamble to the Healthcare ETS, OSHA observed that the development of
safe and highly effective vaccines is a critical milestone in the
nation's response to COVID-19, and that fully vaccinated persons have a
greatly reduced risk of death, hospitalization and other health
consequences. 86 FR 32396. The Healthcare ETS therefore includes
provisions intended to encourage employees to become vaccinated,
including a requirement for employers to provide reasonable paid leave
for vaccination and recovery from any side effects. 86 FR 32415, 29 CFR
1910.502(m).
In the Healthcare ETS OSHA found that employees who work in covered
healthcare workplaces are exposed to grave danger. 86 FR 32411. The
agency also stated that in light of the effectiveness of vaccines,
there was ``insufficient evidence in the record to support a grave
danger finding for non-healthcare workplaces where all employees are
vaccinated.'' 86 FR 32396 (emphasis supplied). OSHA made no finding at
that time regarding unvaccinated workers in non-healthcare workplaces.
No employer challenged the Healthcare ETS in court. The United Food
and Commercial Workers Union (UFCW) together with the AFL-CIO filed a
petition for review asserting that the rule should have gone further
and included more industries in its scope (UFCW and AFL-CIO, June 24,
2021). That case is being held in abeyance pending the issuance of this
ETS.
c. Subsequent Developments
The preamble to the Healthcare ETS notes that new COVID-19 variants
might emerge that are more transmissible and cause more severe illness,
but does not specifically mention the Delta Variant. See 86 FR 32384.
Since publication of the Healthcare ETS, the Delta Variant has become
the dominant form of the virus in the United States, causing large
spikes in transmission, and surges of hospitalizations, and deaths,
overwhelmingly among the unvaccinated (CDC, August 26, 2021; CDC,
October 18, 2021--Variant Proportions, July Through October, 2021). As
discussed in more detail in Grave Danger (Section III.A. of this
preamble), the Delta Variant is at least twice as contagious as
previous COVID-19 variants, and research suggests that it also causes
more severe illness in the unvaccinated population (CDC, August 26,
2021). More infections mean more potential for exposures, including in
workplaces (see Grave Danger, Section III.A. of this preamble, for
further discussion on workplace outbreaks, clusters, and the general
impact of transmission in the workplace.). More infections also mean
more opportunities for the virus to undergo mutations to its genetic
code, resulting in genetic variants with the potential to infect or re-
infect people.
Some variability in infection rates in a pandemic is to be
expected. While the curves of new infections and deaths can bend down
after peaks, they often reverse course only to reach additional peaks
in the future (Moore et al., April 30, 2020). Last year experts
expressed concern that one or more subsequent waves of COVID-19 were
possible in 2021 (Moore et al., April 30, 2020), especially with new
variants of COVID-19 in circulation (Doughton, February 9, 2021). That
potential tragically became a reality with the spread of the Delta
Variant.
In June 2021, when the Healthcare ETS was published, COVID-19
transmission rates in the United States were at a low point, with the
7-day moving average of reported cases to be about 12,000. (CDC, August
26, 2021) However, by the end of July, the 7-day moving average reached
over 60,000 as the Delta Variant spread across the country. (CDC,
August 26, 2021). The 7-day moving average of reported cases at the
beginning of September, 2021 exceeded 161,000 (CDC, October 18, 2021--
Daily Cases). The most recent 7-day moving average of reported cases,
while lower than the peak in late August and early September, is still
over 85,000. (CDC, October 18, 2021--Daily Cases). These rates are also
far higher than the rate when OSHA first declined to issue an ETS.
(CDC, August 27, 2020 (20,401 confirmed cases per day on May 29,
2020)). The jump in infections has resulted in increased
hospitalizations and deaths for unvaccinated workers, as discussed in
detail in Grave Danger (Section III.A. of this preamble). While the
most current data reflect a decline in new cases from the peak, the
level of new cases remains high. CDC data shows that, as of October 18,
2021, approximately 85% of U.S. counties were experiencing ``high''
rates of community transmission, and another 10% were experiencing
``substantial'' community transmission (CDC, October 18, 2021--Daily
Cases). Although the number of new detected cases is currently
declining nationwide (see CDC, October 18, 2021--Community Transmission
Rates), the agency cannot assume based on past experience that
nationwide case levels will not increase again. Indeed, many northern
states are currently experiencing increases in their rate of new cases
(see CDC, October 18, 2021--Cases, Deaths, and Laboratory Testing
(NAATS) by State; Slotnik, October 18, 2021), including Vermont, which
set a new record for new COVID-19 cases in mid-October 2021 (Murray,
October 18, 2021). Unless vaccination rates increase, the experience of
northern states during this fall could presage a greater resurgence in
cases this winter as colder weather drives more individuals indoors
(see Firozi and Dupree, October 18, 2021).
While it is important to recognize that the Delta Variant has
caused a spike in hospitalization and death in the United States, the
SARS-CoV-2 virus, and not just a particular variant of that virus, is
the hazard that workers face (see Grave Danger, Section III.A. of this
preamble). Like any virus, SARS-CoV-2 has the ability to mutate over
time and produce variants that may be more or less severe. Indeed, the
World Health Organization and the CDC both track new variants that have
continued to arise, such as the Lamda and Mu Variants (WHO, October 12,
2021; CDC, October 4, 2021). At this time, the CDC is tracking 11
different variants of COVID-19 (CDC, October 4, 2021). The World Health
Organization has classified the Lambda and Mu variants as ``variants of
interest,'' meaning that they have genetic changes that affect
transmissibility, disease severity, immune escape, diagnostic or
therapeutic escape; and have been identified to cause significant
community transmission or multiple COVID-19 clusters, in multiple
countries with increasing relative prevalence alongside increasing
number of cases over time, or other apparent epidemiological impacts to
suggest an emerging risk to global public health (WHO, October 12,
2021). Medical experts have also explained that vaccination reduces the
opportunities for the virus to continue to mutate by reducing
transmission and length of infection. And, there is no indication that
future variants of COVID-19 will not be equally or even more dangerous
than Delta without a higher rate of vaccination (Bollinger and Ray,
July 23, 2021).
Meanwhile, evidence on the power of vaccines to safely protect
individuals from infection and especially from serious disease has
continued to accumulate. (CDC, May 21, 2021). For example, as explained
in more detail in Grave Danger (Section III.A. of this preamble),
multiple studies have demonstrated that vaccines are highly effective
at reducing instances of hospitalization and death. In September the
CDC compiled data from various studies that demonstrated overall
authorized vaccines reduced death and severe case rates by 91 and 92%
respectively in the population studied between April and July (Scobie
et al., September 17, 2021, Table 1.). Additionally, the FDA granted
approval to the Pfizer-BioNTech COVID-19 Vaccine for individuals 16
years of age and older on August 23, 2021 (FDA, August 23, 2021). In
announcing the decision, the FDA Commissioner explained that ``[w]hile
this and other vaccines have met the FDA's rigorous, scientific
standards for emergency use authorization, as the first FDA-approved
COVID-19 vaccine, the public can be very confident that this vaccine
meets the high standards for safety, effectiveness, and manufacturing
quality the FDA requires of an approved product.'' (FDA, August 23,
2021.)
Despite this important milestone, and the demonstrated
effectiveness of the approved and authorized vaccines available to the
public, millions of employees remain unvaccinated, approximately 39% of
workers who are covered by this ETS (See Economic Analysis, Section
IV.B. of this ETS). The rate of vaccination in the United States
has slowed significantly from its peak in April, when the daily number
of vaccination doses administered exceeded three million at one point.
In recent months, daily vaccination rates have hovered around one
million doses administered, or lower (CDC, October 18, 2021--Daily
Vaccination Rate). The shortfall in vaccination leaves the nation's
working population vulnerable to sickness, hospitalization and death,
whether today under the Delta Variant, or under future variants that
may arise (CDC, October 18, 2021--Daily Vaccination Rate); see also
Grave Danger (Section III.A. of this preamble).
Moreover, in recent months, an increasing number of states have
promulgated Executive Orders or statutes that prohibit workplace
vaccination policies that require vaccination or proof of vaccination
status, thus attempting to prevent employers from implementing the most
efficient and effective method for protecting workers from the hazard
of COVID-19 (see, e.g., Texas Executive Order GA-40, October 11, 2021;
Montana H.B. 702, July 1, 2021; Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021; AZ Executive Order 2021-18, August
16, 2021). While some States' bans have focused on preventing local
governments from requiring their public employees to be vaccinated or
show proof of vaccination, the Texas, Montana, and Arkansas
requirements apply to private employers as well. Other states have
banned local ordinances that require employers to ensure that customers
who enter their premises wear masks, thus endangering the employees who
work there, particularly those who are unvaccinated (see, e.g., Florida
Executive Order 21-102, May 3, 2021; Texas Executive Order GA-34, March
2, 2021).
In short, at the present time, workers are becoming sick and dying
unnecessarily as a result of occupational exposures, when there is a
simple and effective measure, vaccination, that can largely prevent
those deaths and illnesses (see Grave Danger, Section III.A. of this
preamble). Congress charged OSHA with responsibility for issuing
emergency standards when they are necessary to protect employees from
grave danger. 29 U.S.C. 655(c). In light of the current situation, OSHA
is issuing this emergency rule.
References
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``COVID-19 ETS Petition.'' (Cartwright et al., May 7, 2020)
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GKC, Garcia J, Gallego R, Escobar V, Vargas J, Trahan L, Torres NJ,
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(CDC, October 18, 2021)
DeVito J. (2020, March 12). ``Grant OSHA emergency standard for
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Doughton S. (2021, February 9). Can a fourth wave of COVID-19 be
prevented? Not likely, says Fred Hutch model--but the curve could be
flattened. The Seattle Times. https://www.seattletimes.com/seattle-news/health/can-a-fourth-wave-of-covid-19-be-prevented-not-likely-says-fred-hutch-model-but-the-curve-could-be-flattened/. (Doughton,
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Firozee P and Dupree J. (2021, October 18). Coronavirus numbers are
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Dupree, October 18, 2021)
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Executive Order 21-102, May 3, 2021)
Food and Drug Administration (FDA) (2021, August 23). FDA Approves
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Ferguson B, Kaul JL. (2020, May 12).
``COVID-19 ETS Petition.'' (Frosh et al., May 12, 2020)
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``COVID-19 ETS Petition.'' (LULAC, March 31, 2020)
Luong M. (2020, April 30). ``Petition for an OSHA Emergency
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Menendez R, Murray P, Baldwin T, Brown S, Duckworth T, Booker CA,
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19.'' (Menendez et al., March 9, 2020)
Meuser D. (2020, May 1). ``COVID-19 ETS Petition.'' (Meuser, May 1,
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(Moore et al., April 30, 2020)
Murray E. (2021, October 18). Vermont sets new positive COVID daily
case record as delta surge continues. Burlington Free Press. https://www.burlingtonfreepress.com/story/news/local/2021/10/18/covid-vermont-new-daily-positive-case-record-set/8505021002/. (Murray,
October 18, 2021)
Murray P, Brown S, Heinrich M, Brown S, Blumenthal R., Markey EJ,
Van Hollen C, Durbin RJ, Smith T, Whitehouse S, Wyden R, King Jr.
AS, Kaine T, Reed J, Menedez R, Gillibrand K, Duckworth T, Warren E,
Hassan MW, Casey Jr. RP, Sanders B, Udall T, Hirono MK, Harris KD,
Feinstein D, Klobuchar A, Booker CA, Shaheen J, Cardin B. (2020,
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4, 2020)
Novoa M. (2020, June 24). ``Direct OSHA to issue an emergency
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ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
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Owen M. (2020, March 19). ``Grant OSHA emergency standard to protect
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Pellerin C. (2020, March 19). ``Grant OSHA emergency standard to
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Public Citizen. (2020, March 13). ``Support for AFL-CIO's Petition
for an OSHA Emergency Temporary Standard for Infectious Disease to
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Raskin J. (2020, April 29). ``COVID-19 ETS Petition.'' (Raskin,
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Scobie HM et al. (2021, September 17). Monitoring Incidence of
COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
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Scott RC and Adams AS. (2020, January 30). ``Prioritize OSHA's Work
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Slotnik D. (2021, October 18). Coronavirus cases rise in the
northern U.S. amid lower temperatures. The New York Times. https://www.nytimes.com/live/2021/10/18/world/covid-delta-variant-vaccine#covid-cases-us-winter. (Slotnik, October 18, 2021)
International Association of Sheet Metal, Air, Rail and
Transportation Workers (SMART). (2020, March 30). ``Petition for
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Solt BE. (2020, April 28). ``COVID-19 ETS Petition'' (Solt, April
28, 2020)
Talbott R and Adely R. (2020, May 4). ``Rulemaking Petition to the
United States Department of Labor Occupational Safety and Health
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(Texas Executive Order GA-34, March 2, 2021)
Texas Executive Order GA-40. (2021, October 11). https://gov.texas.gov/uploads/files/press/EO-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
United Food and Commercial Workers International Union (UFCW) and
American Federation of Labor and Congress of Industrial
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Wellington M. (2020, March 12). ``Grant OSHA emergency standard for
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protect frontline workers from COVID-19.'' (Yborra, March 19, 2020)
II. This ETS Is Necessary To Protect Unvaccinated Employees From Grave
Danger
As explained at length in the preceding section (Grave Danger,
Section III.A. of this preamble), OSHA has determined that most
unvaccinated workers across the U.S. economy are facing a grave danger
posed by the COVID-19 hazard.\17\ This new hazard has taken the lives
of more than 725,000 people--many of them workers--in the United States
since it was first detected in this country in early 2020. As the
federal agency tasked with protecting the safety and health of workers
in the United States, OSHA is required to act when it finds that
workers are exposed to a grave danger. 29 U.S.C. 655(c)(1). OSHA now
finds that this emergency temporary standard is necessary to protect
employees who are unvaccinated. Asbestos Info. Ass'n, 727 F.2d at 423
(``failure to act does not conclusively establish that a situation is
not an emergency . . . [when there is a grave danger to workers,] to
hold that because OSHA did not act previously it cannot do so now only
compounds the consequences of the Agency's failure to act.''). As
explained in detail below, OSHA has determined that vaccination is the
most effective control for abating the grave danger that unvaccinated
employees face from the COVID-19 hazard. And, for workers who are not
vaccinated, the use of testing, face coverings, and removal from the
workplace, while not as effective as vaccination, is still effective
and necessary.
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\17\ As explained in the Grave Danger section, this ETS focuses
on protecting unvaccinated workers from the grave danger that COVID-
19 poses in the workplace. OSHA did not include fully vaccinated
workers in its finding of grave danger because such workers are
generally much better protected from the effects of COVID-19, and,
in particular, the most severe effects, than workers who are
unvaccinated. OSHA's action in adopting this ETS for unvaccinated
workers does not mean that vaccinated workers do not face a
significant risk from COVID-19, or that the OSH Act's general duty
clause poses no obligation on employers to protect their vaccinated
workers from COVID-19. Indeed, symptomatic infections can occur in
fully vaccinated people, and COVID-19 therefore poses at least some
risk to vaccinated workers. OSHA has requested comment on the risks
faced by vaccinated workers from COVID-19, and what additional
measures, if any, should be taken to protect both vaccinated and
unvaccinated workers (see Request for Comments, Section I.B. of this
preamble).
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OSHA has determined that the best method for addressing the grave
danger that COVID-19 poses to unvaccinated workers is to strongly
encourage the use of the single most effective and efficient protection
available: Vaccination. OSHA
has long recognized the importance of vaccinating workers against
preventable illnesses to which they may be exposed on the job. See 56
FR 64004, 64152 (Dec. 6, 1991) (discussing requirement in Bloodborne
Pathogens standard for employer to make hepatitis B vaccine available
to any employees with occupational exposure to blood and other
potentially infectious materials). As explained in Grave Danger
(Section III.A. of this preamble), COVID-19 vaccines do not completely
eliminate the potential for infection, but significantly reduce the
likelihood of infection, and in turn, transmission of the virus to
others. Data from clinical trials for all three vaccines and
observational studies for the two mRNA vaccines clearly establish that
fully vaccinated persons have a greatly reduced risk of SARS-CoV-2
infection compared to unvaccinated individuals (see FDA, December 11,
2020; FDA, December 18, 2020; FDA, February 26, 2021).
More importantly, vaccination is the single most effective method
for protecting workers from the most serious consequences of a COVID-19
infection: Hospitalization and death. Although symptomatic infections
can occur in fully vaccinated people, they are less likely to occur,
and are far less likely to result in severe health outcomes or death.
As discussed in Grave Danger (Section III.A. of this preamble), studies
have established that the available COVID-19 vaccines are highly
effective at preventing hospitalization, and even more effective at
preventing death. For example, one study found that unvaccinated adults
age 18 to 49 were 15.2 times more likely to be hospitalized and 17.2
times more likely to die of COVID-19 than fully vaccinated people in
the same age range, and unvaccinated adults age 50 to 64 were 10.9
times more likely to be hospitalized and 17.9 times more likely to die
than their fully vaccinated peers (Scobie et al., September 17, 2021).
The New York Times reported on October 1, 2021, that of the
approximately 100,000 individuals who died of COVID-19 since mid-June
2021, less than 3% had been identified by the CDC as vaccinated
individuals (Boseman and Leatherby, October 1, 2021).
Vaccines are also uniquely effective when compared to non-
pharmaceutical methods for controlling exposure to COVID-19 at the
workplace. To be sure, non-pharmaceutical controls play an important
role in employers' efforts to prevent exposure to the virus; as
discussed in detail earlier, OSHA has, throughout the pandemic, advised
employers to implement various administrative, engineering, and other
controls to reduce workplace exposure to the virus. And, for certain
work settings in the healthcare industry where people with COVID-19 are
reasonably expected to be present, OSHA both encouraged vaccination and
mandated a suite of protections, many of which involve physical
controls (see 29 CFR 1910.502). Indeed, workers who work indoors and
near others are best protected from COVID-19 when they are fully
vaccinated and their exposure to COVID-19 is reduced (to the extent
possible) by non-pharmaceutical controls.
Non-pharmaceutical controls, however, focus on preventing employee
exposure to the virus, and do not directly affect an employee's immune
response if exposure to the virus does occur. Additionally, non-
pharmaceutical controls often rely on the actions of individuals and/or
the integrity of equipment to be effective; for example, to use PPE to
control exposure, a worker must correctly don appropriate PPE each time
there is potential exposure, must properly clean, store, and maintain
the PPE between uses, and must replace the PPE when it is no longer
effective (see, e.g., 29 CFR 1910.132 (general PPE requirements in
general industry workplaces)). Accordingly, OSHA standards have always
followed the principle of the hierarchy of controls, under which
employers must control hazards by means other than PPE whenever
feasible, and PPE is a supplementary control. See e.g., 29 CFR
1910.134(a); 29 CFR 1910.1030(d)(2).
Physical distancing requires workers to maintain constant awareness
of their environment in order to avoid coming into close proximity with
colleagues, customers, or other individuals, even though the realities
of their jobs and/or the design of the workplace may be unaccommodating
to that effort. Requiring employees to examine themselves for signs and
symptoms consistent with SARS-CoV-2 infection before reporting to work
is prone to human error and entirely ineffective when the employee is
infected but asymptomatic or pre-symptomatic.
In contrast, a worker is considered fully vaccinated after
completing primary vaccination with a COVID-19 vaccine, or the second
dose of any combination of two doses of a COVID-19 vaccine that is
approved, authorized, or listed as a two-dose primary vaccination by
the FDA or WHO (see the Summary and Explanation for paragraph (c),
Section VI.C. of this preamble). Once fully vaccinated, a worker enjoys
automatic and long-lasting benefits; namely, a drastic reduction in the
risk of severe health effects or death. The vaccine works by bolstering
the worker's immune system and does not depend on the worker's acumen
or actions to afford its protection. Moreover, where an employer
implements one or more non-pharmaceutical controls at the workplace,
vaccination provides workers with a backstop of protection that greatly
reduces their risk of serious health effects if they are exposed to the
virus despite the presence of other controls. Vaccination thus ensures
that workers need not rely on other factors, be it the workplace
environment, the effectiveness of equipment, or the actions of other
individuals, to be substantially protected from the worst potential
outcomes of a COVID-19 infection.
This ETS focuses on encouraging vaccination because it is the most
efficient and effective method for addressing the grave danger.
Vaccination is patently appropriate and feasible for almost every
worker in all industries, and will drastically reduce the risk that
unvaccinated workers will suffer the serious health outcomes associated
with SARS-CoV-2 infection. As described in Section III.A. of this
preamble (Grave Danger), employees who are unvaccinated are in grave
danger from the SARS-CoV-2 virus, but employees who are fully
vaccinated are not. Since it is the lack of vaccination that results in
grave danger, vaccination will best allay the grave danger. This ETS,
which is designed to strongly encourage vaccination, is thus
``necessary to protect employees'' from a grave danger. 29 U.S.C.
655(c).
OSHA continues to encourage employers to implement additional
controls that may be appropriate to eliminate exposure to the SARS-CoV-
2 virus at their workplace, but, as discussed further below, OSHA has
not required employers to implement a comprehensive and multilayered
set of COVID-19 exposure controls in this ETS. This decision reflects
the extraordinary and exigent circumstances have required OSHA to
immediately promulgate this emergency temporary standard. Although OSHA
was able to design a comprehensive infection prevention program for the
specific healthcare settings to which the June 2021 Healthcare ETS
applied, this rule encompasses all industries covered by the OSH Act,
and targets unvaccinated workers in any indoor work setting not covered
by the Healthcare ETS where more than one person is present. Crafting a
multi-layered standard that is comprehensive and feasible for all
covered work settings, including mixed settings of vaccinated and
unvaccinated workers, is an extraordinarily challenging and complicated
undertaking, yet the grave danger that COVID-19 poses to unvaccinated
workers obliges the agency to act as quickly possible. As discussed
above, OSHA has identified vaccination as the single most efficient and
effective means for removing an unvaccinated worker from the grave
danger.
Given the urgency of the rulemaking, and the singular effectiveness
of vaccination in removing unvaccinated workers from the grave danger,
OSHA is promulgating this ETS to immediately address the grave danger
that COVID-19 poses to unvaccinated workers by strongly encouraging
vaccination. As discussed in Pertinent Legal Authority (Section II. of
this preamble), a ``grave danger'' represents a risk greater than the
``significant risk'' that OSHA must show in order to promulgate a
permanent standard under section 6(b) of the OSH Act, 29 U.S.C. 655(b).
OSHA will consider whether it is necessary to require additional
controls to avert a significant risk of harm in the rulemaking
proceedings that follow this ETS. OSHA directs employers to its
website, www.osha.gov/coronavirus, and the CDC's website, www.cdc.gov/coronavirus, for guidance on the engineering, administrative, and other
exposure controls that may be effective and appropriate for their
workplace.
OSHA expects that, by strongly encouraging vaccination, this ETS
will have a positive impact on worker health. As discussed above,
millions of workers remain unvaccinated and are presently exposed to
risks of hospitalization and death many times higher than their
vaccinated coworkers. Although predicting the health impact of this ETS
is particularly challenging, given the ever-changing nature of the
pandemic and the many factors that may motivate workers to become fully
vaccinated, OSHA has attempted to quantify the potential number of
hospitalizations and fatalities that this ETS could avert by increasing
workforce vaccination rates (see OSHA, October 2021c). OSHA has
estimated that, as a result of the ETS, over 6,500 fewer currently
unvaccinated workers will die from COVID-19 over the next six months.
OSHA also estimates that this ETS will prevent over 250,000 currently
unvaccinated workers from being hospitalized during that same time
period. Even if OSHA's estimate does not prove to be precisely
accurate, OSHA is confident that this ETS will save hundreds of lives
and prevent thousands of workers from becoming severely ill.
a. OSHA Finds It Necessary To Strongly Encourage Vaccination
Despite the proven safety and efficacy of the available COVID-19
vaccines, many workers remain unvaccinated and are currently exposed to
a grave danger. As discussed in Grave Danger (Section III.A. of this
preamble), countless COVID-19 outbreaks have occurred in myriad work
settings where employees come into contact with others, and in recent
weeks, the majority of states in the U.S. have experienced what CDC
defines as high or substantial community transmission, indicating that
there is a clear risk of the virus being introduced into and
circulating in workplaces (CDC, October 18, 2021--Community
Transmission Rates). As of October 18, 2021, more than 184 million
people in the United States have been fully vaccinated, but only 68.5%
of people ages 18 years or older are fully vaccinated (CDC, October 18,
2021--Fully Vaccinated). OSHA has estimated that approximately 62.4%
percent of adults aged 18-74 within the scope of this ETS are either
fully vaccinated or received their first vaccine dose during the
previous two weeks, leaving approximately 31.7 million unvaccinated
(i.e., not fully vaccinated and did not receive a first dose with in
the past two weeks) (see Economic Analysis, Section IV.B. of this
preamble, Table IV.B.7). Meanwhile, the rate of new vaccinations has
slowed considerably; on October 15, 2021, the 7-day moving average
number of administered vaccine doses reported to the CDC per day was
841,731 doses, a steep reduction from the peak 3,448,156 dose average
that the CDC reported on April 11, 2021 (CDC, October 18, 2021--Weekly
Review).
Given the pervasiveness of the virus in workplaces across the
country and the unparalleled efficacy of vaccines at preventing serious
health effects, OSHA finds it necessary to strongly encourage
vaccination. Encouraging vaccination is principally necessary to reduce
the likelihood that workers who are infected by the SARS-CoV-2 virus
will suffer the worst outcomes of an infection (hospitalization and
death). Put simply, the single best method for protecting an
unvaccinated worker from the serious health consequences of a COVID-19
infection is for that worker to become fully vaccinated.
Additionally, encouraging vaccination is necessary to reduce the
overall prevalence of the SARS-CoV-2 virus at workplaces. Because
vaccinated workers are less likely than unvaccinated workers to be
infected by the virus, they are less likely to spread the virus to
others at their workplace, including to unvaccinated coworkers.
Increasing workforce vaccination rates will therefore reduce the risk
that unvaccinated workers will be infected by a coworker.
Evidence shows that mandating vaccination has proven to be an
effective method for increasing vaccination rates, and that vaccination
mandates have generally been more effective than merely encouraging
vaccination. Significant numbers of workers would get vaccinated if
their employers required it, and many workers who were vaccinated over
the last four months were motivated by their employer requiring
vaccination. The Kaiser Family Foundation (KFF) vaccine monitor, an
ongoing research project tracking the public's attitudes and
experiences with COVID-19 vaccinations, conducted a survey from
September 13 to September 22, 2021, among a nationally representative
random digit dial telephone sample of 1,519 adults ages 18 and older,
and found that those who received their first dose of a COVID-19
vaccine after June 1, 2021 were motivated by mandates of various sorts,
including one in five (19%) who say a major reason was that their
employer required it (KFF, September 2021). A survey conducted by
Change Research from August 30 to September 2, 2021 regarding
Americans' views on COVID-19 vaccines found that among the 1,775
respondents, ``one of the things that was most likely to lead someone
to get vaccinated was if their employer required it'' (Towey, September
27, 2021).
Vaccine mandates imposed by state governments and large employers
have also demonstrated the effectiveness of mandates in increasing
vaccination rates. For example, when Tyson Foods announced its
vaccination requirement in early August 2021, only 45% of its workforce
had received a vaccination dose, but as of September 30, 2021, the New
York Times reported that has increased to 91% (White House, October 7,
2021; Hirsch, September 30, 2021). Similarly, United Airlines reported
that 97% of its U.S.-based employees were fully vaccinated against
COVID-19 within a week of the deadline of the company's vaccination
mandate, and the 3% who were not fully vaccinated included several
employees who sought a medical or religious exemption from vaccination
(The Associated Press, September 22, 2021). In Washington State, the
weekly vaccination rate increased 34% after the Governor announced
vaccine requirements for
state workers (White House, October 7, 2021). The success of these
COVID-19 vaccination mandates comports with the National Safety
Council's recent finding that employers that instituted a COVID-19
vaccination mandate produced a 35% increase in employee vaccination
(NSC, September 2021). Similarly, the White House recently reported
that its analysis of vaccination requirements imposed by healthcare
systems, educational institutions, public-sector agencies, and private
businesses demonstrated that such requirements increased their
vaccination rates by more than 20 percentage points and have routinely
seen their share of fully vaccinated workers rise above 90 percent
(White House, October 7, 2021).
Given the effectiveness of vaccination mandates in increasing
vaccination rates, OSHA expects that, in most instances, an employer
implementing a policy that requires all employees to be vaccinated will
be the most effective approach for increasing the vaccination rate of
its employees and ensuring that they have the best protection available
against the worst consequences of a COVID-19 infection. Although OSHA
may well have the authority to impose a vaccination mandate, OSHA has
decided against pursuing strict vaccination requirement and has instead
crafted the ETS to strongly encourage vaccination. Employers are in the
best position to understand their workforces and the approach that will
work most effectively with them to secure employee cooperation and
protection. OSHA's traditional practice when including medical
procedures, such as medical surveillance testing and vaccinations, in
its health standards has been to require the employer to make the
medical procedure available to employees, and has viewed mandating
those procedures as a measure to avoid if possible. For example, when
the agency promulgated its standard regulating occupational exposure to
lead, OSHA considered mandating that employees participate in physical
examinations and biological monitoring, but ultimately required
employers to make them available to employees (see 43 FR 54354, 54450
(Nov. 21, 1978)). OSHA decided against mandating those procedures in
part because it believed a voluntary approach would elicit more
effective employee participation in the medical program and in part
because of the agency's concerns about the Government intruding into a
private and sensitive area of workers' lives (43 FR at 54450-51). OSHA
has followed that same approach of requiring employers to ``provide''
or ``make available'' medical procedures to employees in numerous
subsequent standards, such as the standards for asbestos (29 CFR
1910.1001), benzene (1910.1028), cotton dust (1910.1043), and
formaldehyde (1910.1048).
OSHA adhered to this approach when it promulgated the Bloodborne
Pathogens standard. The agency considered mandating a Hepatitis B
vaccination, but instead required employers to make the Hepatitis B
vaccination available to employees. 56 FR 64004, 64155 (Dec. 6, 1991);
29 CFR 1910.1030(f)(1)(i), (f)(2)(i). OSHA explained that the agency
may have the legal authority to mandate vaccination, but believed that,
under the circumstances, a voluntary vaccination program would ``foster
greater employee cooperation and trust in the system'' and ``enhance [
] compliance while respecting individuals' beliefs and rights to
privacy.'' 56 FR at 64155.
In keeping with this traditional practice, the agency has stopped
short of including a strict vaccination mandate with no alternative
compliance option in this ETS. OSHA has never done so, and if it were
to take that step, OSHA believes it more prudent to do so where the
agency has ample time to fully assess the potential ramifications of
imposing a vaccination mandate on covered employers and employees.
Here, exigent circumstances demand that OSHA take immediate action to
protect workers from the grave danger posed by COVID-19, but OSHA has
not had a full opportunity to study the potential spectrum of impacts
on employers and employees, including the economic and health impacts,
that would occur if OSHA imposed a strict vaccination mandate with no
alternative compliance option. Moreover, employers in their unique
workplace settings may be best situated to understand their workforce
and the strategies that will maximize worker protection while
minimizing workplace disruptions. These considerations persuade the
agency that this ETS should afford employers some flexibility in the
form of an alternative option to strictly mandating vaccination. In
light of the unique and grave danger posed by COVID-19, OSHA has
requested comment on whether a strict vaccination mandate is warranted
and the agency will consider all the information it receives as it
determines how to proceed with this rulemaking (see Request for
Comment, Section I.B. of this preamble).
Although this ETS does not impose a strict vaccination mandate,
OSHA has determined that, to adequately address the grave danger that
COVID-19 poses to unvaccinated workers, a more proactive approach is
necessary than simply requiring employers to make vaccination available
to employees. None of the standards that OSHA promulgated prior to this
year concerned an infectious agent as readily transmissible as COVID-
19. Standards like the Lead standard do not concern infectious agents
that can be transmitted between individuals at a workplace;
accordingly, the medical procedures that employers are required to make
available under those standards are solely aimed at protecting the
health of the worker who is undergoing the procedure. The Bloodborne
Pathogens standard concerned exposure to infectious biological agents
(Hepatitis B and HIV) that can be transmitted between individuals, but
the potential for those agents to be transmitted between workers is
minimal in comparison to the SARS-CoV-2 virus; Hepatitis B and HIV are
transmitted through blood and certain body fluids, whereas the SARS-
CoV-2 virus spreads through respiratory droplets that can travel
through the air from worker-to-worker (see Grave Danger, Section III.A.
of this preamble). Vaccination against COVID-19 is thus particularly
important in reducing the potential for workers to become infected and
spread the virus to others at the workplace, in addition to protecting
the worker from severe health outcomes if they are infected. Moreover,
the ease with which the SARS-CoV-2 virus spreads between workers makes
it more urgent for workers to be vaccinated, and this urgency
contributes to the agency's decision to strongly encourage vaccination.
Accordingly, to further the goal of increasing workforce
vaccination rates, this ETS requires employers to implement a mandatory
vaccination policy unless they adopt a policy in which employees may
either be fully vaccinated or regularly tested for COVID-19 and wear a
face covering in most situations when they work near other individuals.
Employers have the duty under the OSH Act to provide safe workplaces to
their employees, including protecting employees from known hazards by
complying with occupational safety and health standards (see 29 U.S.C.
654), and this ETS therefore provides employers with two compliance
options for protecting unvaccinated workers from the grave danger posed
by COVID-19. But while this ETS offers employers a choice in how to
comply, OSHA has presented implementation of a vaccination mandate as
the preferred compliance
option; as discussed above, vaccine mandates have proven to be
effective in increasing vaccination rates, and OSHA expects that, in
most instances, implementing a vaccination mandate will be the most
effective method for increasing a workforce's vaccination rate. As
discussed below, OSHA also recognizes that requiring that all employees
be vaccinated provides more protection to vaccinated workers than
regularly testing unvaccinated workers for COVID-19 and requiring them
to wear face coverings when they work near others. This ETS will
preempt inconsistent state and local requirements, including
requirements that ban or limit employers' authority to require
vaccination (see the Summary and Explanation for paragraph (a), Section
VI.A. of this preamble), and will therefore provide the necessary legal
authorization to covered employers to implement mandatory vaccination
policies, if they choose to comply in this preferred manner.
Although the ETS does not require all covered employers to
implement a mandatory vaccination policy, OSHA expects that employers
that choose that compliance option will enjoy advantages that employers
that opt out of the vaccination mandate option will not. Most
obviously, employers with a mandatory vaccination policy will enjoy a
dramatically reduced risk that their employees will become severely ill
or die of a COVID-19 infection. In addition, employers who implement a
vaccination mandate will likely have fewer workers temporarily removed
from the workplace due to a COVID-19 positive test; this rule requires
all covered employers to remove from the workplace any employee who
tests positive for COVID-19 or receives a diagnosis of COVID-19 (see
the Summary and Explanation for paragraph (h), Section VI.H. of this
preamble), and because vaccinated workers are less likely than
unvaccinated workers to be infected by the virus, OSHA expects
employers with a mandatory vaccination policy will be statistically
less likely to be obliged to remove a COVID-positive employee from the
workplace in accordance with paragraph (h)(2). Additionally, only
employers who decline to implement a mandatory vaccination program are
required by the rule to assume the administrative burden necessary to
ensure that unvaccinated workers are regularly tested for COVID-19 and
wear face coverings when they work near others.
Where employers opt out of implementing a mandatory vaccination
program, the ETS encourages employees to elect to be fully vaccinated.
As discussed in the Summary and Explanation for paragraph (f) (Section
VI.F. of this preamble), the ETS requires all covered employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive each vaccination
dose, and reasonable time and paid sick leave to recover from
vaccination side effects. Many workers have been deterred from
receiving vaccination by fears of missing work and/or losing pay to
obtain vaccination and/or recover from side effects (see Section VI.F.
of this preamble; see, e.g., KFF, May 6, 2021; KFF, May 17, 2021), and
OSHA finds that this employer support is necessary to ensure that
employees can become fully vaccinated without concern that they will be
sacrificing pay or their jobs to do so.
All covered employers are required by the ETS to bear the cost of
providing up to four hours of paid time and reasonable paid sick leave
needed to support vaccination, but where an employee chooses to remain
unvaccinated, the ETS does not require employers to pay for the costs
associated with regular COVID-19 testing or the use of face coverings
(see the Summary and Explanation for paragraphs (g) and (i), Sections
VI.G. and VI.I. of this preamble). In some cases, employers may be
required to pay testing and/or face covering costs under other federal
or state laws or collective bargaining obligations, and some may choose
to do so even without such a mandate, but otherwise employees will be
required to bear the costs if they choose to be regularly tested and
wear a face covering in lieu of vaccination.
This ETS more strongly encourages vaccination than the June 2021
Healthcare ETS. OSHA designed the Healthcare ETS, which addresses the
grave danger that COVID-19 poses workers in specific health care
settings where COVID-19-positive individuals are reasonably likely to
be present, to encourage vaccination (see 86 FR at 32415, 32423, 32565,
32597). Specifically, the Healthcare ETS encourages vaccination by
requiring employers to provide employees reasonable and paid time to
receive vaccination doses and recover from side effects (29 CFR
1910.502(m)), and by exempting from its scope ``well-defined hospital
ambulatory care settings where all employees are fully vaccinated'' and
all non-employees are screened and denied entry if they are suspected
or confirmed to have COVID-19 (1910.502(a)(2)(iv)) and ``home
healthcare settings where all employees are fully vaccinated'' and all
nonemployees at that location are screened prior to employee entry so
that people with suspected or confirmed COVID-19 are not present
(1910.502 (a)(2)(v)).
Similar to the Healthcare ETS, this ETS requires employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive vaccination, and
reasonable time and paid sick leave to recover from vaccination side
effects (see discussion above and the Summary and Explanation for
paragraph (f), Section VI.F. of this preamble). However, as discussed
above, this ETS goes further and expressly requires the implementation
of a mandatory vaccination policy, unless the employer implements an
alternative policy that requires unvaccinated workers to be regularly
tested for COVID-19 and to wear face coverings in most situations when
they work near others. While nothing in the Healthcare ETS prohibits
covered employers from implementing a mandatory vaccination policy,
this ETS presents the implementation of a mandatory vaccination policy
as a preferred compliance option, and will preempt inconsistent state
and local requirements that ban or limit employers' authority to
require vaccination. Additionally, where the employer opts out of
implementing a mandatory vaccination policy, and the employee opts out
of vaccination, this ETS places no obligation on the employer to pay
for costs associated with the regular testing of unvaccinated workers
for COVID-19 or their use of face coverings, which will provide a
financial incentive for some employees to be fully vaccinated.
OSHA finds it necessary to more strongly encourage vaccination in
this ETS than in the Healthcare ETS in the manner described above. The
Healthcare ETS's provisions that encouraged vaccination were packaged
with a comprehensive infection prevention program that was tailored to
the specific healthcare work settings to which the ETS applied,
including a suite of layered and overlapping controls. In contrast,
OSHA is promulgating this ETS to address the grave danger that COVID-19
now poses to all unvaccinated workers who work indoors and in the
presence of others. As mentioned above, crafting a comprehensive and
multi-layered standard that is comprehensive and feasible for the
myriad work settings to which this ETS will apply, including workplaces
as diverse as schools, restaurants, retail settings, offices, prisons,
and factories, is an
extraordinarily challenging and complicated undertaking.
Exigent circumstances require OSHA to immediately promulgate this
ETS to protect unvaccinated workers, and vaccination is the single most
efficient and effective method for removing unvaccinated workers from
the grave danger. Given the urgency of the rulemaking and the singular
efficacy of vaccination, OSHA has decided against including
comprehensive and multilayered exposure controls in this ETS, and is
instead focusing the ETS on strongly encouraging vaccination. Strongly
encouraging vaccination is thus critical to the effectiveness of this
ETS at protecting unvaccinated workers from the grave danger. In
Request for Comment (Section I.B. of this preamble), OSHA seeks
information on what additional measures, if any, should be required to
protect employees against COVID-19.
Moreover, stronger encouragement of vaccination is needed in this
ETS than in the Healthcare ETS because workers who are protected by the
Healthcare ETS are more likely to be vaccinated and/or subject to a
vaccination mandate. The Healthcare ETS, 29 CFR 1910.502, focused on
healthcare work settings where COVID-19 is reasonably expected to be
present, and, this ETS does not apply in settings where any employee
provides healthcare services or healthcare support services while they
are covered by the requirements of 29 CFR 1910.502 (see the Summary and
Explanation for paragraph (b), Section VI.B. of this preamble).
Evidence shows that workers in settings covered by Sec. 1910.502
already have a high rate of vaccination. As of July 2021, healthcare
workers had a higher rate of vaccination than non-healthcare workers
(Lazer et al., August, 2021), and many healthcare workers are currently
subject to vaccination mandates. Twenty-two states and the District of
Columbia have instituted vaccination mandates that are applicable to
healthcare workers (NASHP, October 1, 2021), and nearly 300 hospitals
and broader health systems have implemented vaccine mandates for their
employees (Renton et al., October 14, 2021). The White House reported
that almost 2,500 hospitals, 40% of all U.S. hospitals, across all 50
states, the District of Columbia, and Puerto Rico, have announced
vaccination requirements for their workforce, and noted numerous
examples of highly successful mandates in those workplaces (White
House, October 7, 2021). News reports attest that many of these
vaccination mandates have had great success in increasing the
vaccination rate of the targeted healthcare workers (Goldberg, July 9,
2021; Otterman and Goldstein, September 28, 2021; Hubler, September 30,
2021; Beer, October 4, 2021). Even more healthcare workers covered by
29 CFR 1910.502 will be subject to a vaccination mandate under the
Centers for Medicare & Medicaid Services (CMS) rule published elsewhere
in this issue of the Federal Register that requires COVID-19
vaccinations for workers in most healthcare settings that receive
Medicare or Medicaid reimbursement, including but not limited to
hospitals, dialysis facilities, ambulatory surgical settings, and home
health agencies. This CMS rule applies to at least 76,000 providers
(i.e., employers) and covers a majority of healthcare workers across
the country. OSHA expects that the combination of incentives to
vaccination in the Healthcare ETS and vaccination mandates applicable
to healthcare workers will leave few healthcare workers within the
scope of the Healthcare ETS unvaccinated.
b. Unvaccinated Workers Must Be Regularly Tested for COVID-19 and Use
Face Coverings
As discussed above, this ETS presumptively requires employers to
implement a mandatory vaccination policy, but permits employers to opt
out of that requirement. Nonetheless, the grave danger that COVID-19
poses to unvaccinated workers demands that alternative protective
measures be taken at workplaces where the employer does not implement a
mandatory vaccination policy. Given that the SARS-CoV-2 virus is highly
contagious, transmitted easily through the air, and can lead to severe
and/or fatal outcomes in unvaccinated workers, it is critical that
employers who do not require their employees to be vaccinated implement
controls to mitigate the potential for COVID-19 outbreaks to occur. As
discussed above, and in Grave Danger (Section III.A. of this preamble),
unvaccinated workers are more likely than vaccinated workers to be
infected with COVID-19 and transmit the virus to others, and thus pose
a heightened risk of spreading the virus at the workplace, including to
other unvaccinated workers.
To reduce the risk that unvaccinated workers will spread COVID-19
at the workplace, this rule requires employers that do not implement a
mandatory vaccination policy to ensure that unvaccinated workers who
report to a workplace where others are present are tested at least once
a week for COVID-19. As discussed in the Summary and Explanation for
paragraph (g) (Section VI.G. of this preamble), it is well-established
that, by identifying and isolating infected individuals, regularly
testing individuals for COVID-19 infection can be an effective method
for reducing virus transmission. Regularly testing unvaccinated workers
is essential because SARS-CoV-2 infection is often attributable to
asymptomatic or presymptomatic transmission (Bender et al., February
18, 2021; Byambasuren et al., December 11, 2020; Johansson et al.,
January 7, 2021; Klompas et al., September 2021). In accordance with
the CDC's recommendations, OSHA has set the minimum frequency of
testing at 7 days because the agency expects that it will be effective
in slowing the spread of COVID-19, while taking into account associated
cost considerations (see the Summary and Explanation for paragraph (g),
Section VI.G. of this preamble). As noted in the Request for Comment
(Section I.B. of this preamble), OSHA is gathering additional
information about whether OSHA should require testing more often than
on a weekly basis.
The requirement for unvaccinated workers to be regularly tested for
COVID-19 operates in tandem with paragraph (h)(2), which requires that
all employers remove from the workplace any employee who receives a
positive COVID-19 test, or a COVID-19 diagnosis (see the Summary and
Explanation for paragraph (h), Section VI.H. of this preamble).
Paragraph (h)(2) ensures that the COVID-19-positive employee will be
isolated from the workplace until it is safe for the employee to
return, and also allows the employee to seek medical care sooner and
reduce the likelihood that they will suffer the most severe
consequences of an infection (e.g., by seeking monoclonal antibody
treatment). The combination of the testing and medical removal
provisions will reduce the likelihood that an unvaccinated worker who
has been infected with COVID-19, including those who are not
experiencing symptoms of infection, will be permitted to spread the
virus to others at the workplace, including unvaccinated coworkers.
Additionally, OSHA finds it necessary to require employers that do
not implement a mandatory vaccination policy to ensure that
unvaccinated workers wear face coverings in most situations when they
are working near others. This reflects OSHA's recognition that
regularly testing unvaccinated workers for COVID-19 will not be 100%
effective in identifying infected workers before they enter the
workplace. Most obviously, testing employees once a week will not
prevent an unvaccinated
worker from exposing others at the workplace if the worker becomes
infected and reports to the workplace in between their weekly tests.
And, even if the rule required unvaccinated workers to be tested more
frequently than once a week, infected persons may still be missed,
particularly in areas with high community spread (Chin et al.,
September 9, 2020).
Accordingly, requiring unvaccinated workers to wear face coverings
in most situations when they are working near others will further
mitigate the potential for unvaccinated workers to spread the virus at
the workplace. As discussed in the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble), it is well-established
that face coverings provide effective source control; that is, they
largely prevent respiratory droplets emitted by the wearer of the face
covering from spreading to others, and thus make it significantly less
likely that the person wearing the mask will transmit the virus, if
they are infected. Face coverings are also believed to provide the
wearer some limited protection from exposure to the respiratory
droplets of co-workers and others (e.g., customers) (CDC, May 7, 2021),
but the principal benefit of face coverings is to significantly reduce
the wearer's ability to spread the virus. By requiring unvaccinated
workers to wear face coverings, this rule significantly reduces the
likelihood that an infected unvaccinated worker who enters the
workplace despite the testing requirements will spread the virus to
others, including unvaccinated coworkers.
OSHA acknowledges that regularly testing unvaccinated workers for
COVID-19 and requiring them to wear face coverings when they work near
others is less protective of unvaccinated workers than simply requiring
all workers to be vaccinated. To be sure, OSHA strongly prefers that
employers adopt a mandatory vaccination policy, as vaccination is
singularly effective at protecting workers from the severe consequences
that can result from a COVID-19 infection. And, where employers do not
adopt a mandatory vaccination policy, employers may also consider
alternative feasible measures that would remove employees who remain
unvaccinated from the scope of this ETS, such as increasing telework
(see the Summary and Explanation for paragraph (b), Section VI.B. of
this preamble). Nonetheless, as discussed above, OSHA has not imposed a
strict vaccination mandate on all covered employees who work in the
presence of others and not exclusively outdoors, given that the agency
has never previously used its authority to strictly mandate
vaccination, and the exigent and extraordinary circumstances driving
this emergency rulemaking have not afforded OSHA a full opportunity to
assess the potential ramifications of including a strict vaccination
mandate in this rule. Given these circumstances, and employers' unique
understanding of the compliance approaches that will best increase
vaccination rates among their workforce, OSHA has designed a rule that
preserves a limited degree of employer flexibility, and strongly
encourages, but does not strictly require, vaccination. OSHA has
requested comment in this ETS on whether a strict vaccination mandate
would be appropriate and the agency will consider those comments as it
determines how to proceed with this rulemaking.
References
Beer T. (2021, October 4). COVID-19 Vaccine Mandates Are Working--
Here's The Proof. Forbes. https://www.forbes.com/sites/tommybeer/2021/10/04/covid-19-vaccine-mandates-are-working-heres-the-proof/?sh=1a08d2e72305. (Beer, October 4, 2021)
Bender JK et al. (2021, February 18). Analysis of asymptomatic and
presymptomatic transmission in SARS-CoV-2 outbreak, Germany, 2020.
Emerging Infectious Diseases. 27(4). https://doi.org/10.3201/eid2704.204576. (Bender et al., February 18, 2021)
Boseman J and Leatherby L. (2021, October 1). U.S. Coronavirus Death
Toll Surpasses 700,000 Despite Wide Availability of Vaccines. The
New York Times. https://www.nytimes.com/2021/10/01/us/us-covid-deaths-700k.html. (Boseman and Leatherby, October 1, 2021)
Byambasuren O et al., (2020, December 11). Estimating the extent of
asymptomatic COVID-19 and its potential for community transmission:
Systematic review and meta-analysis. Official Journal of the
Association of Medical Microbiology and Infectious Disease Canada.
5(4): 223-234 doi:10.3138/jammi-2020-0030. (Byambasuren et al.,
December 11, 2020)
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Science brief: Community use of cloth masks to control the spread of
SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-SARS-cov2.html. (CDC, May 7, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
Chin E et al. (2020, September 9). Frequency of routine testing for
COVID-19 in high-risk healthcare environments to reduce outbreaks.
https://doi.org/10.1101/2020.04.30.20087015. (Chin et al., September
9, 2020)
Food and Drug Administration (FDA). (2020, December 11). Emergency
use authorization for an unapproved product review memorandum
(Pfizer-BioNTech COVID-19 vaccine/BNT 162b2 mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020, December 18). Emergency
use authorization for an unapproved product review memorandum
(Moderna COVID-19 vaccine/mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021, February 26). Janssen
COVID-19 vaccine. Vaccines and Related Biological Products Advisory
Committee February 26, 2021 Meeting Briefing Document. https://www.fda.gov/media/146219/download. (FDA, February 26, 2021)
Goldberg C. (2021, July 9). Hospital Vaccine Mandates Suggest
Success in Boosting U.S. Shots. Bloomberg News. https://www.bloomberg.com/news/articles/2021-07-09/early-mandates-boost-worker-vaccine-rates-prompt-few-to-quit. (Goldberg, July 9, 2021)
Hirsch L. (2021, September 30). After Mandate, 91% of Tyson Workers
Are Vaccinated. https://www.nytimes.com/2021/09/30/business/tyson-foods-vaccination-mandate-rate.html. (Hirsch, September 30, 2021)
Hubler S. (2021, September 30). `Mandates Are Working': Employer
Ultimatums Life Vaccination Rates, So Far. The New York Times.
https://www.nytimes.com/2021/09/30/us/california-vaccine-mandate-health-care.html. (Hubler, September 30, 2021)
Johansson MA et al., (2021, January 7). SARS-CoV-2 transmission from
people without COVID-19 symptoms. JAMA Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.2020.35057. (Johansson et al., January
7, 2021)
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, September). Does The Public
Want To Get A COVID-19 Vaccine? When? https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/?utm_source=web&utm_medium=trending&utm_campaign=COVID-19-vaccine-monitor#messagesandinformation. (KFF, September 2021)
Klompas M et al. (2021, September). The case for mandating COVID-19
vaccines for health care workers. Annals of Internal Medicine.
https://doi.org/10.7326/M21-2366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID States Project: A 50-State
COVID-19 Survey Report #62: COVID-19 Vaccine Attitudes Among
Healthcare Workers. http://news.northeastern.edu/uploads/COVID19%20CONSORTIUM%20REPORT%2062%20HCW%20August%202021.pdf. (Lazer
et al., August, 2021)
National Academy for State Health Policy (NASHP). (2021, October 1).
State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and
Passports. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/. (NASHP, October 1, 2021)
National Safety Council (NSC). (2021, September). A Year in Review,
and What's Next: COVID-19 Employer Approaches and Worker
Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (NSC, September 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
Otterman S and Goldstein J. (2021, September 28). Thousands of N.Y.
Health Care Workers Get Vaccinated Ahead of Deadline. The New York
Times. https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html. (Otterman and Goldstein, September 28,
2021)
Renton B et al. (2021, October 14). New: Hospital Vaccine Mandate
Tracker. Global Epidemics, Brown School of Public Health. https://globalepidemics.org/2021/07/24/new-hospital-vaccine-mandate-tracker/
. (Renton et al., October 14, 2021)
Scobie HM et al. (2021, September 17). Monitoring Incidence of
COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
The Associated Press. (2021, September 22). United Airlines says 97%
of US employees have been vaccinated. https://www.wifr.com/2021/09/22/united-airlines-say-97-us-employees-have-been-vaccinated/. (The
Associated Press, September 22, 2021)
Towey R. (2021, September 27). CNBC poll shows very little will
persuade unvaccinated Americans to get Covid shots. https://www.cnbc.com/2021/09/10/cnbc-poll-shows-very-little-will-persuade-unvaccinated-americans-to-get-covid-shots.html. (Towey, September
27, 2021)
White House. (2021, October 7). White House Report: Vaccination
Requirements Are Helping Vaccinate More People, Protect Americans
from COVID-19, and Strengthen the Economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
III. No Other Agency Action is Adequate To Protect Employees Against
Grave Danger
OSHA's experience to date shows that the agency's existing tools
are inadequate to meet the grave danger posed by COVID-19 to
unvaccinated workers not covered by the Healthcare ETS. OSHA has
determined that its existing standards, regulations, the OSH Act's
General Duty Clause, and non-mandatory guidance will not adequately
promote the most effective means to protect these workers: Vaccination.
The agency has determined that this ETS is necessary to address these
inadequacies. Multiple developments support this change in approach.
First, large numbers of employees are continuing to contract COVID-19
and die. (See Grave Danger, Section III.A. of this preamble). Further,
based on a thorough review of its existing approach to protecting
employees from COVID-19 and the current state of the pandemic, OSHA
finds that existing OSHA standards, regulations, the General Duty
Clause, and non-mandatory guidance are not adequate to protect
employees outside healthcare from COVID-19. The Preamble to the
Healthcare ETS includes a detailed analysis demonstrating the
inadequacy of existing tools in the healthcare industry. See 86 FR
32414-32423. In general, the same analysis applies here. The reasons
existing tools were inadequate to protect healthcare workers apply in
other industry sectors as well. The Healthcare ETS itself, while
necessary to protect healthcare workers, of course applies only to that
industry. Finally, the numerous guidance products published by other
entities, such as CDC, are not adequate to protect employees because
they are not enforceable; there is no penalty for noncompliance. 86 FR
at 32415. Even as the CDC has increasingly recommended vaccination to
protect from the dangers of transmission and severe illness related to
the SARS-CoV-2 virus, vaccination rates remain uneven around the
country. (CDC, September 9, 2021; Leonhardt, September 7, 2021; KFF,
October 6, 2021; McPhillips and Cohen, May 19, 2021).
The need for this ETS is also reflected in the number of states and
localities that have issued their own mandatory standards in
recognition that OSHA's existing measures (including non-mandatory
guidance, compliance assistance, and enforcement of existing standards)
have failed to prevent the spread of the virus in workplaces.
Additionally, as mentioned previously, other states have banned certain
employers from implementing workplace vaccination mandates or from
verifying an employee's vaccination status or from requiring face
coverings. A national standard is necessary to establish clear
requirements regarding vaccination, testing and face coverings that
will protect employees in all states and preempt state or local
ordinances that prevent employers from implementing necessary
protections.
a. The Current Standards and Regulations Are Inadequate
In the Healthcare ETS, OSHA considered its enforcement efforts with
regard to existing standards and regulations that OSHA had identified
as potentially applicable to occupational exposure to SARS-CoV-2.
OSHA's analysis in Section IV of the Healthcare ETS, 86 FR 32376,
32416-17 and hereby included in the record of this ETS,\18\ is
applicable here in considering the need for this ETS, which covers a
much broader set of employers in all industries. There OSHA found that
none of the existing OSHA standards could sufficiently abate the hazard
posed by COVID-19 in healthcare settings. Here again OSHA concludes
that the potentially applicable existing standards are insufficient to
address the grave danger faced by workers covered by this ETS. None of
the current standards, even if more rigorously enforced, can
sufficiently address this cross-industry hazard of national proportions
to abate the grave danger posed by COVID-19 or lead to the same
benefits that this ETS will achieve. See Asbestos Info. Ass'n/N. Am. v.
Occupational Safety & Health Admin., 727 F.2d 415, 427 (5th Cir. 1984)
(``[M]uch of the claimed benefit could be obtained simply by enforcing
the current standard.'').
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\18\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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Through its enforcement guidance, OSHA identified a number of
current standards and regulations that might apply when workers have
occupational exposure to SARS-CoV-2, most of which are the same
standards OSHA considered in the Healthcare ETS. (Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19))
(OSHA, July 7, 2021). OSHA has also cited the Hazard communication
standard (29 CFR 1910.1200) during COVID-19 investigations.
Accordingly, a list of
potentially applicable standards and regulations follows:
29 CFR part 1904, Recording and Reporting Occupational
Injuries and Illnesses. This regulation requires certain employers to
keep records of work-related fatalities, injuries, and illnesses and
report them to the government in specific circumstances.
29 CFR 1910.132, General requirements--Personal Protective
Equipment (PPE). This standard requires that appropriate PPE, including
PPE for eyes, face, head, and extremities, protective clothing,
respiratory devices, and protective shields and barriers, be provided,
used, and maintained in a sanitary and reliable condition.
29 CFR 1910.134, Respiratory protection. This standard
requires that employers provide, and ensure the use of, appropriate
respiratory protection when necessary to protect employee health.
29 CFR 1910.141, Sanitation. This standard applies to
permanent places of employment and contains, among other requirements,
general housekeeping and waste disposal requirements.
29 CFR 1910.145, Specification for accident prevention
signs and tags. This standard requires the use of biological hazard
signs and tags, in addition to other types of accident prevention signs
and tags.
29 CFR Subpart U--COVID-19 Emergency Temporary Standard.
The Healthcare ETS, promulgated on June 21, 2021 includes various
controls (patient screening and management, respirators and other PPE,
limiting exposure to aerosol-generating procedures, physical
distancing, physical barriers, cleaning, disinfection, ventilation,
health screening and medical management, access to vaccination, anti-
retaliation provisions, and medical removal protection) to address the
grave danger posed by COVID-19 to healthcare workers.
29 CFR 1910.1020, Access to employee exposure and medical
records. This standard requires that employers provide employees and
their designated representatives access to relevant exposure and
medical records.
29 CFR 1910.1200, Hazard communication. This standard
requires employers to keep Safety Data Sheets (SDS) for chemical
hazards, provide SDSs to employees and their representatives when
requested, and train employees about those hazards. The standard does
not apply to biological hazards, but hazard communication becomes an
issue for the SARS-CoV-2 virus when chemicals are used to disinfect
surfaces.
OSHA again finds that none of these existing standards provide for
the types of workplace controls that are necessary to combat the grave
danger addressed by this ETS. First, none of the listed potentially
applicable standards require vaccination against SARS-CoV-2, the most
efficient and effective control to combat the grave danger posed by the
virus. (The Bloodborne Pathogen Standard requires that the hepatitis B
vaccine be made available to certain employees, but that is not that is
not relevant here, since the hepatitis vaccine provides no protection
against COVID-19). Nor are the additional safety measures included in
this ETS--vaccination verification, screening testing, face coverings,
and medical removal of COVID-19 positive workers-- required by existing
standards other than OSHA's Healthcare ETS (covering employees exempted
from this new ETS while the Healthcare ETS is in effect).
Second, because existing standards do not contain provisions
specifically targeted at the COVID-19 hazard, it may be difficult for
employers and employees to determine what particular COVID-19 safety
measures are required by existing standards, or how the separate
standards are expected to work together as applied to COVID-19. An ETS
that contains provisions specifically addressing COVID-19 hazards in
covered workplaces will provide clear instructions. More certainty will
lead to more compliance, and more compliance will lead to improved
protection of employees covered by this standard.
Third, requirements in some standards may be appropriate for other
situations but simply do not contemplate COVID-19 and fail to address
important aspects of the hazard. For example, the general sanitation
standard requires employers to provide warm water, soap, and towels
that can be used in hand washing, but does not require disinfection or
provision of hand sanitizer where handwashing facilities cannot be made
readily available. See 86 FR 32417. Although the sanitation standard
might appear at first glance to be relevant here, it simply does not
require the types of controls that would, even if more rigorously
enforced, sufficiently reduce the threat of COVID-19 in the workplace.
As such, OSHA affirms its previous determination that some of the
above-listed standards--including the sanitation standard--are in
practice too difficult to apply to the COVID-19 hazard and have never
been cited in COVID enforcement. 86 FR 32416.
Fourth, existing recordkeeping and reporting regulations do not
adequately allow the employer or the agency to assess the full scope of
COVID-19 workplace exposures and protection. OSHA's general
recordkeeping regulations were not written with the nature of COVID-19
transmission or illness in mind. In order to adequately understand and
thereby control the spread of COVID-19 in the workforce, it is critical
that the employer has records of employees' vaccination status, and of
the testing undergone by employees who do not receive vaccination, and
that it knows of all cases of COVID-19 occurring among employees.
However, such information is outside of the scope of OSHA's existing
recordkeeping requirements, which are limited to injuries or illnesses
that the employer knows to be work-related.
Moreover, existing reporting regulations do not adequately ensure
that OSHA has the full picture of the impact of COVID-19 because those
regulations only require employers to report in-patient
hospitalizations that occur within 24 hours of the work-related
incident and to report fatalities that occur within thirty days of the
work-related incident. 86 FR at 32417. Many COVID-19 infections will
not result in hospitalization or death until well after these limited
reporting periods. Under existing regulations, such cases are not
required to be reported to OSHA, which limits the agency's ability to
fully understand the impact of COVID-19 on the workforce. 86 FR 32417.
This ETS includes a provision, paragraph (k), that removes the time
limitation on reporting for COVID-19 cases.
In conclusion, OSHA's experience has demonstrated that existing
standards and regulations are inadequate to address the current COVID-
19 hazard.
b. The General Duty Clause Is Inadequate To Meet the Current Crisis
Section 5(a)(1) of the OSH Act, or the General Duty Clause,
provides the general mandate that each employer ``furnish to each of
[its] employees employment and a place of employment which are free
from recognized hazards that are causing or are likely to cause death
or serious physical harm to [its] employees.'' 29 U.S.C. 654(a)(1). For
General Duty Clause citations to be upheld, OSHA must demonstrate
elements of proof that are supplementary to, and can be more difficult
to show than, the elements of proof required for violations of specific
standards, where a hazard is presumed. Specifically, to prove a
violation of the General Duty Clause, OSHA needs to
establish--in each individual case--that: (1) An activity or condition
in the employer's workplace presented a hazard to an employee; (2) the
hazard was recognized; (3) the hazard was causing or was likely to
cause death or serious physical harm; and (4) feasible means to
eliminate or materially reduce the hazard existed. BHC Nw. Psychiatric
Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir. 2020). OSHA
often relies on the General Duty Clause to fill gaps where specific
standards do not address a hazard and OSHA enforces it through case-by-
case adjudicative proceedings. See United States v. Strum, 84 F.3d 1, 5
(1st Cir. 1996).
OSHA has previously found the General Duty Clause to be inadequate
to protect employees from dangers posed by infectious agents. In
promulgating the bloodborne pathogens standard, OSHA explained that
enforcement under the General Duty Clause was insufficient to protect
employees from the serious hazards those pathogens present. 56 FR 64007
(December 6, 1991). In the recently promulgated Healthcare ETS, OSHA
found that the General Duty Clause was insufficient to protect
healthcare workers from the grave danger they faced as well. 86 FR
32418. While OSHA initially attempted to use the General Duty Clause to
protect employees across all industries from COVID-19-related hazards,
OSHA's experience has demonstrated that the Clause is grossly
inadequate to protect employees covered by this ETS from the grave
danger posed by COVID-19 in the workplace. As explained more fully
below, OSHA finds this ETS is necessary to protect employees from the
hazards of COVID-19.
As an initial matter, the General Duty Clause does not provide
employers with specific requirements to follow or a roadmap for
implementing appropriate abatement measures. The ETS, however, provides
a clear statement of what OSHA expects employers to do to protect
workers, thus facilitating better compliance. The General Duty Clause
is so named because it imposes a general duty to keep the workplace
free of recognized serious hazards; the ETS, in contrast, lays out
clear requirements for employers to implement vaccination policies
including vaccination verification, support for employee vaccination,
screening testing and face coverings for unvaccinated workers, and
medical removal of COVID-19 positive employees. Conveying obligations
as clearly and specifically as possible makes it much more likely that
employers will comply with those obligations and thereby protect
workers from COVID-19 hazards. See, e.g., Integra Health Mgmt., Inc.,
2019 WL 1142920, at *7 n.10 (No. 13-1124, 2019) (noting that standards
``give clear notice of what is required of the regulated community'');
56 FR 64007 (``because the standard is much more specific than the
current requirements [general standards and the general duty clause],
employers and employees are given more guidance in carrying out the
goal of reducing the risks of occupational exposure to bloodborne
pathogens'').
Moreover, several characteristics of General Duty Clause
enforcement actions make them an inadequate means to address hazards
associated with COVID-19. First, it would be virtually impossible for
OSHA to require and enforce the most important worker-protective
elements of the ETS (such as vaccination and testing) under the General
Duty Clause. Second, OSHA's burden of proof for establishing a General
Duty Clause violation is heavier than for standards violations. Third,
promulgating an ETS will enable OSHA to issue more meaningful penalties
for willful and egregious violations, thus creating effective
deterrence against employers who intentionally disregard their
obligations under the Act or demonstrate plain indifference to employee
safety. As discussed in more detail below, all of these considerations
demonstrate OSHA's need to promulgate this ETS in order to protect
unvaccinated workers covered by this standard from hazards posed by
COVID-19.
The General Duty Clause is ill-suited to requiring employers to adopt
vaccination and testing policies, like those required by the ETS
Because the General Duty Clause requires OSHA to establish the
existence and feasibility of abatement measures that can materially
reduce a hazard, it is difficult for OSHA to use the clause to require
specific control measures where an employer is doing something, but not
what the Secretary has determined is needed to fully address the
serious hazard. See, e.g., Waldon Health Care Center, 16 BNA OSHC 1052,
1993 WL 119662 at * (No. 89-2804, 1993) (vacating OSHA citation
requiring pre-exposure hepatitis B vaccination under General Duty
Clause by finding that although vaccination would more fully reduce the
hazard, the employer's chosen means of abatement were sufficient);
Brown & Root, Inc., Power Plant Div., 8 BNA OSHC 2140, 1980 WL 10668 at
*5 (No. 76-1296, 1980) (``[T]he employer may defend against a section
5(a)(1) citation by asserting that it was using a method of abatement
other than the one suggested by the Secretary.'').
Further, even where OSHA establishes a violation of the General
Duty Clause, the employer is under no obligation to implement the
feasible means of abatement proven by OSHA as part of its prima facie
case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717, at *4
(No. 76-616, 1983) (``[The employer] is not required to adopt the
abatement method suggested by the Secretary, even one found feasible by
the Commission; it may satisfy its duty to comply with the standard by
using any feasible method that is appropriate to abate the
violation.''); Brown & Root, Inc., Power Plant Div., 1980 WL 10668 at
*5. Thus, even in cases where OSHA prevails, the employer need not
necessarily implement the specific abatement measure(s) OSHA
established would materially reduce the hazard. The employer could
select alternative controls and then it would be up to OSHA, if it
wished to cite the employer again, to establish that the recognized
hazard continued to exist and that its preferred controls could
materially reduce the hazard even further.
Given the severity and pervasiveness of the COVID-19 hazard, OSHA
has determined that the specific abatement measures provided in this
ETS are necessary to protect workers from grave danger. Under the
General Duty Clause alone, it would be nearly impossible to require
employers to provide these specific measures, and even then, it could
only be on a case-by-case enforcement basis. Considering the magnitude
and ubiquity of the danger that SARS-CoV-2 poses to workers across the
country, the case-by-case adjudicatory regime set up through the
General Duty Clause is simply not adequate to combat the risk of severe
illness and death caused by the virus.
General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
Under the General Duty Clause OSHA must prove that there is a
recognized hazard, i.e., a workplace condition or practice to which
employees are exposed, creating the potential for death or serious
physical harm to employees. See SeaWorld of Florida LLC v. Perez, 748
F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management, 2019 WL
1142920, at *5. Whether a particular workplace condition or practice is
a ``recognized hazard'' under the General Duty Clause is a question of
fact that must be decided in each individual case. See SeaWorld of
Florida LLC, 748 F.3d at 1208. In the case of a COVID-19-related
citation, this means showing
not just that the virus is a hazard as a general matter--a fairly
indisputable point--but also that the specific conditions in the cited
workplace, such as unvaccinated, unmasked employees working in close
proximity to other employees for extended periods, create a COVID-19-
related hazard.
In contrast, an OSHA standard that requires or prohibits specific
conditions or practices establishes the existence of a hazard. See
Harry C. Crooker & Sons, Inc. v. Occupational Safety & Health Rev.
Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v. Sec'y of Labor,
638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement proceedings
under OSHA standards, as opposed to the General Duty Clause, ``the
Secretary need not prove that the violative conditions are actually
hazardous.'' Modern Drop Forge Co. v. Sec'y of Labor, 683 F.2d 1105,
1114 (7th Cir. 1982). With OSHA's finding that the hazard of exposure
to COVID-19 can exist for unvaccinated workers in all covered
workplaces (see Grave Danger, Section III.A. of this preamble), the ETS
will eliminate the burden to repeatedly prove, workplace by workplace,
the existence of a COVID-19 hazard under the General Duty Clause.
One of the most significant advantages to standards like the ETS
that establish the existence of the hazard at the rulemaking stage is
that the Secretary can require specific abatement measures without
having to prove that a specific cited workplace is already
hazardous.\19\ In contrast, as discussed above, under the General Duty
Clause the Secretary cannot require abatement before proving in the
enforcement proceeding that an existing condition at the workplace is
hazardous. For example, in a challenge to OSHA's Grain Handling
Standard, which was promulgated in part to protect employees from the
risk of fire and explosion from accumulations of grain dust, the Fifth
Circuit acknowledged OSHA's inability to effectively protect employees
from these hazards under the General Duty Clause in upholding, in large
part, the standard. See Nat'l Grain & Feed Ass'n v. Occupational Safety
& Health Admin., 866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's
difficulty in proving explosion hazards of grain handling under General
Duty Clause). Although OSHA had attempted to address fire and explosion
hazards in the grain handling industry under the General Duty Clause,
``employers generally were successful in arguing that OSHA had not
proved that the specific condition cited could cause a fire or
explosion.'' Id. at 721 & n.6 (citing cases holding that OSHA failed to
establish a fire or explosion hazard under the General Duty Clause).
The Grain Handling Standard, in contrast, established specific limits
on accumulations of grain dust based on its combustible and explosive
nature, and the standard allowed OSHA to cite employers for exceeding
those limits without the need to prove at the enforcement stage that
each cited accumulation was likely to cause a fire or explosion. See
id. at 725-26.
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\19\ ``The Act does not wait for an employee to die or become
injured. It authorizes the promulgation of health and safety
standards and the issuance of citations in the hope that these will
act to prevent deaths and injuries from ever occurring.'' Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also Arkansas-Best
Freight Sys., Inc. v. Occupational Safety & Health Rev. Comm'n, 529
F.2d 649, 653 (8th Cir. 1976) (noting that the ``[OSH] Act is
intended to prevent the first injury'').
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The same logic applies to COVID-19 hazards. Given OSHA's burden
under the General Duty Clause to prove that conditions at the cited
workplace are hazardous, it is difficult for OSHA to ensure necessary
abatement before individual employee lives and health are unnecessarily
endangered by exposure to COVID-19, despite widespread evidence of the
grave danger posed by worker exposure to COVID-19. Indeed, despite
publishing a voluminous collection of COVID-19 guidance online and
receiving and investigating thousands of complaints, OSHA did not
believe it could justify the issuance of more than 20 COVID-19 related
General Duty Clause citations over the entire span of the pandemic so
far, because of the quantum of proof the Secretary must amass under the
General Duty Clause. Unlike enforcement under the General Duty Clause,
this ETS allows OSHA to cite employers for each protective requirement
they fail to implement without the need to wait for employee infection
or death to prove in an enforcement proceeding that the particular
cited workplace was hazardous without that particular measure in place.
Thus, this ETS, which covers millions of workers nation-wide, is
significantly preferable to the General Duty Clause with respect to
such a highly transmissible virus because the inability to prevent a
single exposure can quickly result in an exponential increase in
exposures and illnesses or fatalities even at a single worksite.
An additional limitation of the General Duty Clause is that proving
that there are feasible means to materially reduce a recognized hazard
typically requires testimony from an expert witness in each separate
case, which limits OSHA's ability to prosecute these cases as broadly
as needed to protect workers, in light of the expense involved. See,
e.g., Integra Health Management, 2019 WL 1142920, at *13 (requiring
expert witness to prove proposed abatement measures would materially
reduce hazard). In contrast, where an OSHA standard specifies the means
of compliance, the agency has already made the necessary technical
determinations in the rulemaking and therefore does not need to
establish feasibility of compliance as part of its prima facie case in
an enforcement proceeding. See, e.g., A.J. McNulty & Co. v. Sec'y of
Labor, 283 F.3d 328, 334 (D.C. Cir. 2002); S. Colorado Prestress Co. v.
Occupational Safety & Health Rev. Comm'n, 586 F.2d 1342, 1351 (10th
Cir. 1978). Preventing the initial exposure and protecting as many
workers as quickly as possible is especially critical in the context of
COVID-19 because, as explained in Grave Danger, Section III.A. of this
preamble, it can spread so easily in workplaces.
The ETS will also permit OSHA to achieve meaningful deterrence when
necessary to address willful or egregious failures to protect employees
against the COVID-19 hazard
As described above, in contrast to the broad language of the
General Duty Clause, this ETS will prescribe specific measures
employers covered by this standard must implement. This specificity
will make it easier for OSHA to determine whether an employer has
intentionally disregarded its obligations or exhibited a plain
indifference to employee safety or health. In such instances, OSHA can
classify the citations as ``willful,'' allowing it to propose higher
penalties, with increased deterrent effects. In promulgating the
Healthcare ETS, OSHA noted that early in the pandemic, shifting
guidance on the safety measures employers should take to protect their
employees from COVID-19 created ambiguity regarding employers' specific
obligations. Thus, OSHA could not readily determine whether a
particular employer had ``intentionally'' disregarded obligations that
were not yet clear. And, even as the guidance began to stabilize,
OSHA's ability to determine ``intentional disregard'' or ``plain
indifference'' was difficult, for example, when an employer took some
steps address the COVID-19 hazard. 86 FR 32420. The Healthcare ETS
largely resolved this issue for employers covered by that standard, by
laying out clearly what parameters to put in place to protect
healthcare workers. However, this general challenge persists in OSHA's
attempts at enforcement in other industries.
Further, OSHA has adopted its ``egregious violation'' policy to
impose sufficiently large penalties that achieve appropriate deterrence
against bad actor employers who willfully disregard their obligation to
protect their employees when certain aggravating circumstances are
present, such as a large number of injuries or illnesses, bad faith, or
an extensive history of noncompliance (OSHA Directive CPL 02-00-080
(October 21, 1990)). Its purpose is to increase the deterrent impact of
OSHA's enforcement activity. This policy utilizes OSHA's authority to
issue a separate penalty for each instance of noncompliance with an
OSHA standard, such as each employee lacking the same required
protections, or each workstation lacking the same required controls. It
can be more difficult to use this policy under the General Duty Clause
because the Fifth Circuit and the Occupational Safety and Health Review
Commission have held that, under the General Duty Clause, OSHA may only
cite a hazardous condition once, regardless of its scope or the number
of workers affected. Reich v. Arcadian Corp., 110 F.3d 1192, 1199 (5th
Cir. 1997). Thus, even where OSHA finds that an employer willfully
failed to protect a large number of employees from a COVID-19 hazard,
OSHA might not be able to cite the employer on a per-instance basis for
failing to protect each of its employees. The provisions of this ETS
have been intentionally drafted to make clear OSHA's authority to
separately cite employers for each instance of the employer's failure
to protect employees and for each affected employee, where appropriate.
By providing needed clarity, the ETS will facilitate ``willful''
and ``egregious'' determinations that are critical enforcement tools
OSHA can use to adequately address violations by employers who have
shown a conscious disregard for the health and safety of their workers
in response to the pandemic. Without the necessary clarity, OSHA has
been limited in its ability to impose penalties high enough to motivate
the very large employers who are unlikely to be deterred by penalty
assessments of tens of thousands of dollars, but whose noncompliance
can endanger thousands of workers. Indeed, OSHA has only been able to
issue two COVID-19-related ``willful'' citations and no ``egregious''
citations since the start of the pandemic because of the challenges
described above.
For all of the reasons described above, and after over a year of
attempting to use the General Duty Clause to address this widespread
hazard, OSHA finds that the General Duty Clause is not an adequate
enforcement tool to protect employees covered by this standard from the
grave danger posed by COVID-19.
c. OSHA and Other Entity Guidance Is Insufficient
OSHA has issued numerous non-mandatory guidance products to advise
employers on how to protect workers from SARS-CoV-2 infection (see
https://www.osha.gov/coronavirus). Even the most comprehensive guidance
makes clear, as it must, that the guidance itself imposes no new legal
obligations, and that its recommendations are ``advisory in nature.''
(See OSHA's online guidance, Protecting Workers: Guidance on Mitigating
and Preventing the Spread of COVID-19 in the Workplace (OSHA, Updated
August 13, 2021); and OSHA's earlier 35-page booklet, Guidance on
Preparing Workplaces for COVID-19, (OSHA, March 9, 2020)). This
guidance, as well as guidance products issued by other government
agencies and organizations, including the CDC, the Centers for Medicare
& Medicaid Services (CMS), the Institute of Medicine (IOM), and the
World Health Organization (WHO), help protect employees to the extent
that employers voluntarily choose to implement the practices they
recommend. Unfortunately, OSHA's experience and the continued spread of
COVID-19 throughout the country shows that does not happen consistently
or rigorously enough, resulting in inadequate protection for employees.
For example, the CDC has strongly recommended vaccination since
vaccines became widely available earlier in the year, but many
employees have yet to take this simple step, which would protect
themselves and their co-workers from the danger of COVID-19.
As documented in numerous peer-reviewed scientific publications,
CDC, IOM, and WHO have recognized a lack of compliance with non-
mandatory recommended infection-control practices (Siegel et al., 2007;
IOM, 2009; WHO, 2009). As noted in the preamble to the Healthcare ETS,
OSHA was aware of these findings when it previously concluded that an
ETS was not necessary, but at the time of that conclusion, the agency
erroneously believed that it would be able to effectively use the non-
mandatory guidance as a basis for establishing the mandatory
requirements of the General Duty Clause, and informing employers of
their compliance obligations under existing standards. 86 FR 32421. As
explained above, that has not proven to be an effective strategy.
Moreover, when OSHA made its initial necessity determination at the
beginning of the pandemic, it made an assumption that given the
unprecedented nature of the COVID-19 pandemic, there would be an
unusual level of widespread voluntary compliance by the regulated
community with COVID-19-related safety guidelines. (See, e.g., DOL, May
29, 2020 at 20 (observing that ``[n]ever in the last century have the
American people been as mindful, wary, and cautious about a health risk
as they are now with respect to COVID-19,'' and that many ``protective
measures are being implemented voluntarily, as reflected in a plethora
of industry guidelines, company-specific plans, and other sources'')).
Since that time, however, developments have led OSHA to conclude
that the same uneven compliance documented by CDC, IOM, and WHO is also
occurring for the COVID-19 guidance issued by OSHA and other agencies.
For example, rising ``COVID fatigue'' or ``pandemic fatigue'' has been
reported for nearly a year already--i.e., a decrease in voluntary use
of COVID-19 mitigation measures over time (Meichtry et al., October 26,
2020; Silva and Martin, November 14, 2020; Belanger and Leander,
December 9, 2020; Millard, February 18, 2021). Other reasons that
people have not followed COVID-19 guidance include fear of financial
loss; skepticism about the danger posed by COVID-19; and even a simple
human tendency, called ``psychological reactance,'' to resist curbs on
personal freedoms, i.e., an urge to do the opposite of what somebody
tells you to do (Belanger and Leander, December 9, 2020; Markman, April
20, 2020). OSHA is seeing evidence of these trends in its COVID-19
enforcement. For example, although OSHA has issued guidance since the
spring of 2020 encouraging the use of physical distancing and barriers
as a means of protecting employees at fixed work locations, there have
been a number of news reports indicating that employers ignore that
guidance (Romo, November 19, 2020; Richards, May 5, 2020; Lynch, July
9, 2020). This was evidenced by a cross-sectional study performed from
late summer to early fall of 2020 in New York and New Jersey that found
non-compliance and widespread inconsistencies in COVID-19 response
programs (Koshy et al., February 4, 2021). Indeed, OSHA continues to
receive complaints and referrals attesting to such workplace practices.
(OSHA, October 17, 2021). Worse, some employers must now deal with
employees who not only have yet to be vaccinated but compound the
danger by hiding their unvaccinated status and declining to wear source
protection that would identify them as unvaccinated, even though it
could provide some protection to their coworkers, in workplaces where
there is a stigma attached to being unvaccinated. (Ember and Murphy
Marcos, August 7, 2021). This ETS contains notification and vaccine
verification requirements that address these avoidant behaviors and
mitigate the hazard of undisclosed exposure and transmission (see the
Summary and Explanation for paragraphs (e), (g), and (h), Sections
VI.E., VI.G., and VI.H. of this preamble).
OSHA's more recent guidance update encourages employers to
facilitate employee vaccination by providing paid time off and
encourages testing and masks for unvaccinated workers. However, as
discussed previously, vaccination rates remain inconsistent across the
country and have slowed significantly since the spring of 2021. And
infection rates remain high, especially among the unvaccinated. It is
clear, as discussed previously, that voluntary self-regulation by
employers will not sufficiently reduce the danger that COVID-19 poses
in workplaces covered by this standard. As noted in the White House
Report on vaccination requirements released on October 7, at this time
only 25% of businesses have vaccine mandates in place (White House,
October 7, 2021). Since this ETS and other federal efforts to require
vaccination were announced more private and public sector institutions
have begun to prepare to implement vaccination requirements, further
demonstrating the need for this rule as an impetus for employer action
(White House, October 7, 2021).
The high number of COVID-19-related complaints and reports that
OSHA continues to receive on a regular basis suggests a lack of
widespread compliance with existing voluntary guidance: From March 2020
to October 2021, OSHA has continued to receive hundreds of COVID-19-
related complaints every month, including over 400 complaints during
the month of August 2021, and over 450 complaints to date in the month
of September (OSHA, October 11, 2021). And, as of October 17, OSHA has
received 223 additional COVID-19-related complaints. (OSHA, October 17,
2021). If guidance were followed more strictly, or if there were enough
voluntary compliance with steps to prevent illness, OSHA would expect
to see a significant reduction in COVID-19-related complaints from
employees.
The dramatic increases in the percentage of the population that
contracted the virus during the summer of 2021 indicates a continued
risk of COVID-19 transmission in workplace settings (for more
information on the prevalence of COVID-19 see Grave Danger, Section
III.A. of this preamble) despite OSHA's publication of numerous
specific and comprehensive guidance documents. OSHA has found that
neither reliance on voluntary action by employers nor OSHA non-
mandatory guidance is an adequate substitute for specific, mandatory
workplace standards at the federal level. Public Citizen v. Auchter,
702 F.2d 1150 at 1153 (voluntary action by employers ``alerted and
responsive'' to new health data is not an adequate substitute for
government action).
d. A Uniform Nationwide Response to the Pandemic Is Necessary To
Protect Workers
As the pandemic has continued in the United States, there has been
increasing recognition of the need for a more consistent national
approach (GAO, September, 2020; Budryk, November 17, 2020; Horsley, May
1, 2020; DOL OIG, February 25, 2021). Many employers have advised OSHA
that they would welcome a nationwide ETS. For example, in its October
9, 2020 petition for a COVID-19 ETS, ORCHSE Strategies, LLC explained
that it is ``imperative'' that OSHA issue an ETS to provide employers
one standardized set of requirements to address safety and health for
their workers (ORCHSE, October 9, 2020). This group of prominent
business representatives explained that an ETS would eliminate
confusion and unnecessary burden on workplaces that are struggling to
understand how best to protect their employees in the face of confusing
and differing requirements across states and localities.
The lack of a national standard on this hazard has led to
increasing imbalance in state and local regulation, a problem that OSHA
already identified as concerning in its Healthcare ETS. See 86 FR 32413
(``The resulting patchwork of state and local regulations led to
inadequate and varying levels of protection for workers across the
country, and has caused problems for many employees and businesses.'')
Since the Healthcare ETS was published, states and localities have
taken increasingly more divergent approaches to COVID-19 vaccination,
vaccination verification, screening testing, and the use of face
coverings in the workplace. Currently, the spectrum ranges from states
and localities requiring vaccine mandates and face coverings to states
prohibiting or restricting them, with many states falling somewhere in
between. Due to uneven approaches to vaccination across the country,
states with the lowest rates of vaccination have COVID-19 infection
rates four times as high as in states with the highest vaccine rates.
(Leonhardt, September 7, 2021). Given that thousands of working age
people continue to be infected with COVID-19 each week, many of whom
will become hospitalized or die, OSHA recognizes that a patchwork
approach to worker safety has not been successful in mitigating this
infectious disease outbreak (CDC, October 18, 2021--Cases, By Age). It
has become clear that a Federal standard, by way of this ETS, is
necessary to provide clear and consistent protection to employees
across the country. As explained in Pertinent Legal Authority (Section
II. of this preamble) and the Summary and Explanation for paragraph (a)
(Section VI.A. of this preamble), OSHA has the authority to
comprehensively address the issue(s) described in this ETS, and the
standard is intended to preempt conflicting state and local laws.
In sum, based on its enforcement experience during the pandemic to
date, OSHA concludes that continued reliance on existing standards and
regulations, the General Duty Clause, and guidance, in lieu of an ETS,
is not adequate to protect unvaccinated employees from the grave danger
of being infected by, and suffering death or serious health
consequences from, COVID-19.
References
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Rule Breakers? Scientific American. https://www.scientificamerican.com/article/what-motivates-covid-rule-breakers/. (Belanger and Leander, December 9, 2020)
Budryk Z. (2020, November 17). Fauci calls for `a uniform approach'
to coronavirus pandemic. The Hill. https://thehill.com/policy/healthcare/526378-fauci-calls-for-a-uniform-approach-to-the-coronavirus-pandemic?rl=1. (Budryk, November 17, 2020)
Centers for Disease Control and Prevention (CDC). (2021, September
9). Your COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/your-vaccination.html. (CDC, September 9, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
Ember S and Murphy Marcos C. (2021, August 7). They Don't Want the
Shot. They Don't Want Colleagues to Know. The New York Times.
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2021)
Government Accountability Office (GAO). (2020, September). COVID-19:
Federal Efforts Could Be Strengthened by Timely and Concerted
Actions. https://www.gao.gov/assets/710/709934.pdf. (GAO, September
2020)
Horsley S. (2020, May 1). U.S. Workplace Safety Rules Missing in the
Pandemic. National Public Radio. https://www.npr.org/2020/05/01/849212026/it-s-the-wild-west-u-s-workplace-safety-rules-missing-in-the-pandemic. (Horsley, May 1, 2020)
Institute of Medicine (IOM). (2009). Respiratory Protection for
Healthcare Workers in a Workplace Against Novel H1N1 Influenza A: A
letter report. The National Academies Press. http://www.nap.edu/catalog/12748.html. (IOM, 2009)
Kaiser Family Foundation (KFF). (2021, October 6). Latest Data on
COVID-19 Vaccinations by Race/Ethnicity. https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race-ethnicity/. (KFF, October 6, 2021)
Koshy K et al., (February 4, 2021). Perspectives of region II OSHA
authorized safety and health trainers about initial COVID-19
response programs. Safety Science 138. https://doi.org/10.1016/j.ssci.2021.105193. (Koshy et al., February 4, 2021)
Leonhardt D. (2021, September 7). One in 5,000. The New York Times.
https://www.nytimes.com/2021/09/07/briefing/risk-breakthrough-infections-delta.html. (Leonhardt, September 7, 2021)
Lynch R. (2020, July 9). Orange County to crack down on gyms that
ignore Covid-19 safety guidelines. Orlando Business Journal. https://www.bizjournals.com/orlando/news/2020/07/09/orange-county-gyms-could-face-scrutiny-for-not.html. (Lynch, July 9, 2020)
Markman A. (2020, April 20). Why are there still so many coronavirus
skeptics? Fast Company. https://www.fastcompany.com/90492518/why-are-there-still-so-many-coronavirus-skeptics. (Markman, April 20,
2020)
McPhillips D and Cohen E. (2021, May 19). Uneven vaccination rates
across the US linked to COVID-19 case trends, worry experts. CNN
Health. https://www.cnn.com/2021/05/19/health/uneven-vaccination-rates-covid-19-trends/index.html. (McPhillips and Cohen, May 19,
2021)
Meichtry S et al. (2020, October 26). Pandemic Fatigue is Real--And
It's Spreading; Collective exhaustion with coronavirus restrictions
has emerged as a formidable adversary for governments. The Wall
Street Journal. https://www.wsj.com/articles/pandemic-fatigue-is-realand-its-spreading-11603704601. (Meichtry et al., October 26,
2020)
Millard E. (2021, February 18). How to not let pandemic fatigue turn
into pandemic burnout. Everyday Health. https://www.everydayhealth.com/coronavirus/how-to-not-let-pandemic-fatigue-turn-into-pandemic-burnout/. (Millard, February 18, 2021)
Occupational Safety and Health Administration (OSHA). (2020, March
9). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
March 9, 2020
Occupational Safety and Health Administration (OSHA). (2021, July
7). Updated Interim Enforcement Response Plan for Coronavirus
Disease 2019 (COVID-19). https://www.osha.gov/laws-regs/standardinterpretations/2021-07-07. (OSHA, July 7, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Protecting Workers: Guidance on Mitigating and Preventing the
Spread of COVID-19 in the Workplace. https://www.osha.gov/coronavirus/safework. (OSHA, Updated August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, October
17). Summary Data for Federal and State Programs--Enforcement.
https://www.osha.gov/enforcement/covid-19-data#complaints_referrals.
(OSHA, October 17, 2021)
ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
(OSHA) for an Emergency Temporary Standard (ETS) for Infectious
Disease.'' (ORCHSE, October 9, 2020)
Richards C. (2020, May 5). 2 Utah County businesses told staff to
ignore COVID-19 guidelines, resulting in 68 positive cases. Daily
Herald. https://www.heraldextra.com/news/local/2-utah-county-businesses-told-staff-to-ignore-covid-19-guidelines-resulting-in-68-positive/article_d8426991-a693-5879-9d88-f9e094aef5b5.html.
(Richards, May 5, 2020)
Romo V. (2020, November 19). Tyson managers suspended after
allegedly betting if workers would contract COVID. National Public
Radio. https://www.npr.org/2020/11/19/936905707/tyson-managers-suspended-after-allegedly-betting-if-workers-would-contract-covid.
(Romo, November 19, 2020)
Siegel J, Rhinehart E, Jackson M, Chiarello L, and the Healthcare
Infection Control Practices Advisory Committee. (2007). 2007
Guideline for isolation precautions: Preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007)
Silva C and Martin M. (2020, November 14). U.S. Surgeon General
Blames ``Pandemic Fatigue'' for Recent COVID-19 Surge. NPR. https://www.npr.org/sections/coronavirus-live-updates/2020/11/14/934986232/u-s-surgeon-general-blames-pandemic-fatigue-for-recent-covid-19-surge. (Silva and Martin, November 14, 2020)
United States Department of Labor (DOL) and Office of the Inspector
General (OIG). (2021, February 25). COVID-19: Increased Worksite
Complaints and Reduced OSHA Inspections Leave U.S. Workers' Safety
at Increased Risk. http://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021)
United States Department of Labor (DOL). (2020, May 29). In Re:
American Federation Of Labor And Congress Of Industrial
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Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29,
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requirements are helping vaccinate more people, protect Americans
from COVID-19, and strengthen the economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
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Hygiene in Health Care: A Summary--First Global Patient Safety
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IV. Conclusion
This pandemic continues to take a massive toll on American society,
and addressing it requires a comprehensive national response. This ETS
is part of that response. OSHA shares the nation's hope for the promise
of recovery created by the vaccines. But in the meantime, it recognizes
that we have not yet succeeded in defeating the virus, and that many
workers across the country are in grave danger. Therefore, this ETS,
with mitigation measures emphasizing worker vaccination, is necessary.
Although OSHA finds it necessary to institute specific mitigation
measures for the immediate future, the agency can adjust as conditions
change. Even after issuing an ETS, OSHA retains the flexibility to
update the ETS to adjust to the subsequent evolution of CDC workplace
guidance. This ETS addresses (and incorporates as a main component) the
major development in infection control over the last year--the
development and growing implementation of COVID-19 vaccines. Going
forward, further developments can be addressed through OSHA's
authority to modify the ETS if needed, or to terminate it entirely if
vaccination and other efforts end the current emergency. However, at
this point in time, the available evidence indicates that the ETS is
necessary to protect unvaccinated employees across the country from the
grave danger of COVID-19.
IV. Feasibility
A. Technological Feasibility
This section presents an overview of the technological feasibility
assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19
that requires all employers with 100 or more employees to ensure that
all employees are fully vaccinated unless they implement a policy
requiring employees to undergo testing for COVID-19 at least once every
seven days and wear face coverings.
Technological feasibility has been interpreted broadly to mean
``capable of being done'' (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S.
490, 509-510 (1981)). A standard is technologically feasible if the
protective measures it requires already exist, can be brought into
existence with available technology, or can be created with technology
that can reasonably be expected to be developed, i.e., technology that
``looms on today's horizon'' (United Steelworkers of Am., AFL-CIO-CLC
v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I)); Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3d Cir. 1978)).
Courts have also interpreted technological feasibility to mean that a
typical firm in each affected industry or application group will
reasonably be able to implement the requirements of the standard in
most operations most of the time (see Public Citizen v. OSHA, 557 F.3d
165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at
990).
OSHA issued an ETS in June 2021 to protect healthcare and
healthcare support employees in covered healthcare settings from
exposure to SARS-CoV-2. See 86 FR 32376 (June 21, 2021) (Healthcare
ETS). OSHA found the requirements in that ETS to be technologically
feasible, including a requirement for employers to pay for vaccination
of employees that is very similar to the requirement in this new ETS.
OSHA's finding that the Healthcare ETS was technologically feasible was
primarily based on available evidence showing that most healthcare
employers, and employers across all industry sectors, had already
implemented, or were in process of implementing, procedures similar to
those required by the Healthcare ETS. Similarly, OSHA's feasibility
findings for this ETS are based on evidence that vaccination and
testing policies, along with the use of face coverings consistent with
recommendations from the CDC, have been implemented in multiple
industry sectors as testing and vaccinations were made more widely
available during the course of the pandemic.
As discussed in Summary and Explanation (Section VI. of this
preamble), this ETS for vaccination and testing applies to all
employers with 100 or more employees, except as noted here. It does not
apply to workplaces covered under the Safer Federal Workforce Task
Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors or settings where any employee provides healthcare
services or healthcare support services when subject to the
requirements of the Healthcare ETS (29 CFR 1910.502). It also does not
apply to employees who do not report to a workplace where other
individuals such as coworkers or customers are present, employees while
they are working from home, or employees who work exclusively outdoors.
As noted above, OSHA has the legal duty to demonstrate that the
average employer covered by this ETS can comply with that standard in
most operations most of the time. This legal analysis is therefore
focused solely on whether employers with 100 or more employees can
comply with the standard. OSHA's rationale for that scope threshold of
100 or more employees is explained in the Summary and Explanation for
paragraph (b), Section VI.B. of this preamble.
As discussed below, OSHA finds no technological feasibility
barriers related to compliance with the requirements in the ETS. These
requirements include establishing and implementing a written mandatory
COVID-19 vaccination policy or alternative policy requiring testing and
face coverings; determining employee vaccination status; supporting
employee vaccination by providing paid time for vaccination and time
off for recovery; ensuring that employees who are not fully vaccinated
are tested for COVID-19 at least once every seven days and wear face
coverings; and recordkeeping for employee vaccination status and
testing.
OSHA reviewed numerous large-scale employer surveys and vaccination
and testing policies developed by employers, public health
organizations, trade association, and local, state, and federal
governmental bodies. While OSHA discusses several examples of these
plans and policies below,\20\ OSHA's feasibility determination is based
on all evidence in the rulemaking record. The majority of the survey
data and other publicly available material that OSHA reviewed pertains
to large employers with 100 or more employees.
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\20\ While OSHA references several employers' policies, this is
not intended to serve as an endorsement of those plans or an
indication that those plans comply with the ETS. Rather, the plans
and best practice documents show that developing and implementing
policies to address employee COVID-19 vaccination in various
workplaces is capable of being done in a variety of industries, and
therefore, compliance with the ETS is technologically feasible.
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Additionally, OSHA thoroughly reviewed current and future
projections of the availability of COVID-19 tests, testing supplies,
and laboratory capacity. Based on a review of vaccination and testing
policies among large employers, OSHA has determined that most employers
covered by this standard across a wide range of industries have either
already implemented vaccination and testing programs and require
unvaccinated employees to wear face coverings, or are capable of
implementing programs that comply with the requirements in the ETS most
of the time. OSHA therefore finds that the standard is technologically
feasible.
I. Employer Policy on Vaccination
Paragraph (d)(1) of the ETS requires each covered employer to
establish and implement a written mandatory vaccination policy unless
the employer adopts an alternative policy requiring COVID-19 testing
and face coverings for unvaccinated employees, which is discussed
later. To meet the definition of ``mandatory vaccination policy'' under
paragraph (c), the policy must require: Vaccination of all employees,
including all new employees as soon as practicable, other than those
employees (1) for whom a vaccine is medically contraindicated, (2) for
whom medical necessity requires a delay in vaccination, or (3) those
legally entitled to a reasonable accommodation under federal civil
rights laws because they have a disability or sincerely-held religious
beliefs, practices, or observances that conflict with the vaccination
requirement.
OSHA requires employers to implement a mandatory vaccination
requirement, but provides an exemption for an alternative policy that
allows employees to choose either to be fully vaccinated or to be
regularly tested and wear a face covering. This compliance options mean
that the ETS is
technologically feasible if employers across various industries are
capable of implementing either policy, but nevertheless OSHA analyzes
both employer policy options to demonstrate that there are no
significant technological barriers to either approach.
OSHA reviewed several large-scale employer surveys related to
vaccination policies across the country covering a wide range of
industry sectors. Surveys conducted by Arizona State University (ASU)
and the World Economic Forum (WEF), called COVID-19 Workplace Commons--
Keeping Workers Well, show that most employers already have some type
of vaccination policy, with more than 60 percent of surveyed employers
requiring vaccinations for some or all employees. These survey results
further support OSHA's determination that the vaccination policy
requirement is feasible.
The ASU WEF workplace COVID-19 surveys collected information from
employers across industry sectors about their response to the COVID-19
pandemic. The results and responses from more than 1,400 companies are
publicly available through the ASU College of Health Solutions web page
COVID-19 Diagnostics Commons (ASU, October 5, 2021). Case studies from
employers are also available within the interactive dashboard on that
web page. The surveys consisted of numerous questions about workplace
pandemic response, including questions related to vaccination policies
and testing unvaccinated employees.
The most recent COVID-19 survey data was collected between August
2, 2021 and August 20, 2021 and reported in September 2021 (accessible
through the COVID-19 Workplace Commons). More than 1,400 companies
operating 1143 facilities in 23 industry sectors were part of the
survey, the majority of which are companies of the size covered by the
ETS. Ninety percent of facilities surveyed had 100 or more employees at
their facilities, and 56% had more than 100 but less than 1,000
employees at their facilities. The industry sectors surveyed include:
Technology and software; business and professional services;
manufacturing; construction; healthcare, hospitals, and clinics; retail
stores; retail food stores; consumer retail service; energy and
utilities; nonprofit organizations; education (colleges and
universities); education (pre-K to 12); real estate and property
management; agriculture and food production; healthcare services; media
and entertainment; government and quasi-public; biotech,
pharmaceuticals, and diagnostics; restaurants and food service; hotels
and casinos; transportation, distribution, and logistics; consumer
transportation; and recreation (ASU WEF, September 2021).
The survey responses related to vaccination policies support OSHA's
determination that it is feasible for covered employers to implement
mandatory COVID-19 vaccination policies. The survey results showed that
45% of employers surveyed require all employees to be vaccinated
against COVID-19, and an additional 16% require some of its employees
to be vaccinated against COVID-19. (ASU WEF, September 2021). Only
three percent of employers surveyed did not have a vaccination policy
at the time (ASU WEF, September 2021). While this survey covers a wide
range of industries it may not represent the percentage of companies
implementing mandatory vaccination policies in general populations but
for the feasibility purposes it demonstrates that it has and can be
done.
OSHA also reviewed slightly older survey data, which, even though
it shows somewhat lower rates of employer vaccination mandates, still
supports OSHA's finding that such vaccination polices are feasible. In
late June 2021, the National Safety Council (NSC) conducted three
national surveys, one organizational and two workforce, of private
companies, nonprofits, legal experts, public health professionals,
medical professionals and government agencies that have addressed
workforce COVID-19 vaccinations based on best practices and proven
workplace safety strategies. The survey results show that many
employers and organizations are currently requiring employees to be
vaccinated.
The three surveys were distributed to 300 employers and
organizations across the country and from a wide range of industries to
collect data on pandemic response, including implementation of COVID-19
vaccine policies and testing among their workforce. Of the employers
and organizations surveyed in June 2021, the NSC found that 20% were
implementing some form of a worker vaccination requirement. While OSHA
believes that the ASU WEF surveys (which included more employers and
are more recent) are better indicators of current employer vaccination
policies, the NSC surveys also support the feasibility of employer
vaccination mandates (NSC, September 2021)
The NSC, in partnership with the Health Action Alliance (HAA) and
the Centers for Disease Control and Prevention (CDC), have developed a
multifaceted, comprehensive effort called SAFER, aimed at helping
employers prioritize health and safety as they develop plans and
polices for their employees to return to the workplace (NSC, May 17,
2021). Through SAFER, the NSC and HAA developed a web-based decision
tool to guide employers on health, legal, and other considerations to
prioritize the health and safety of workers. Due to the Delta Variant
surge of new COVID-19 cases across the United States, the NSC and HAA
revised the SAFER resources, including the online tool, to include
information about employer requirements for COVID-19 vaccinations.
These include guides for developing plans and policies to support
employee vaccination through mandates and incentives; the collection
and maintenance of COVID-19 vaccination records; and various
considerations for testing unvaccinated workers. (HAA and NSC,
September 17, 2021). The availability of these publicly-accessible
tools to help employers develop vaccination policies further reduces
any potential barriers for covered employers to establish and implement
a written policy requiring each employee to be fully vaccinated against
COVID-19, or alternatively to establish a policy allowing employees to
choose whether to be fully vaccinated or tested for COVID-19 at least
every seven days and wear face coverings.
The HAA maintains an online list of large companies requiring
vaccinations for all or part of their workforce or customers. OSHA
reviewed the list of companies, drawn from news reports and employer
websites, with requirements for COVID-19 vaccination. Most of the
companies listed require some or all employees to be vaccinated against
COVID-19 while allowing medical exemptions or reasonable accommodations
for disability or religious reasons. There are currently 188 listed
companies across numerous industry sectors, including Amtrak, Deloitte,
Google, The Walt Disney Company, Walmart, and the U.S. Chamber of
Commerce.\21\
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\21\ https://www.healthaction.org/resources/vaccines/covid-19-vaccines-employer-requirements-health-action-alliance?0405d6f4_page=1 (last visited October 2, 2021).
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While healthcare employers subject to 29 CFR 1910.502 are not
covered by this ETS, a number of large healthcare employers have
implemented mandatory vaccine policies. This also shows the feasibility
of the employers implementing mandatory vaccination requirements, often
on large scales. According to the American Hospital Association (AHA),
over 1,800 hospitals
have one or more vaccination requirements in place (Becker's Hospital
Review, October 11, 2021). Large healthcare employers mandating that
their employees be vaccinated include Kaiser Permanente, the nation's
largest integrated, nonprofit health care organization with more than
216,000 employees and more than 23,000 physicians (Kaiser Permanente,
August 2, 2021); Trinity Health, one of the largest multi-institutional
Catholic health care delivery systems in the nation, with more than
123,000 employees and 90 hospitals in 22 states (Trinity Health, July
8, 2021); Sanford Health, which operates in 26 states and employs
nearly 50,000 people (Sanford Health, July 22, 2021); and Genesis
Health Care, a large U.S. nursing home chain with over 40,000 employees
working in more than 250 centers across 23 states (Genesis Health Care,
September 29, 2021).
Under paragraph (d)(2), if employers do not establish and implement
a written mandatory vaccination policy, the employer must establish and
implement a written policy allowing any employees not subject to a
mandatory vaccination policy to either choose to be fully vaccinated or
regularly tested for COVID-19 and wear a face covering. A substantial
number of employers already have such policies in place. For example,
the ASU WEF survey shows that 30% of employers surveyed require
unvaccinated employees to participate in mandatory COVID-19 testing and
30% of employers require face coverings for unvaccinated employees (ASU
WEF, September 2021).
OSHA also notes a number of state COVID-19 vaccination
requirements. In response to the Delta Variant surge, 19 states have
implemented written COVID-19 vaccination and testing policies for state
employees and 23 states have done so for healthcare employees (NASHP,
October 1, 2021). For example, on September 20, 2021, the Colorado
Department of Public Health and Environment (CDPHE) implemented
policies requiring state employees and personnel at health care
facilities and hospitals to be fully vaccinated against COVID-19. All
state employees must either be fully vaccinated against COVID-19 or
participate in twice-weekly testing. Employees are allowed work time to
get tested and administrative or Public Health Emergency Leave to get
vaccinated. Employees who are not fully vaccinated must wear masks
inside state facilities when they are around others. On August 30,
2021, the State Board of Health approved a vaccine requirement for
personnel in health care settings with high-risk patients. All
personnel affected by this rule needed to receive their first dose of
COVID-19 vaccine by September 30, 2021, and must be fully vaccinated by
October 31, 2021 (CDPHE, September 17, 2021).
A number of local governments have also implemented policies
requiring COVID-19 vaccination or testing for employees. For example,
the Fulton County Board of Commissioners in Georgia recently approved a
``Vax or Test'' policy requiring employees to get vaccinated or tested
for COVID-19 each week. Since September 6, 2021, Fulton County has
required all County employees, as a condition of employment, to either
be vaccinated against COVID-19 or be tested weekly for COVID-19 unless
an employee is granted a reasonable accommodation (Fulton County
Government, September 03, 2021). The multitude of local, state, and
employer vaccination or testing mandates across the country support
OSHA's finding that such policies are feasible.
II. Determining Employee Vaccination Status
Paragraph (e) of the ETS requires employers to determine the
vaccination status of each employee. Employers must require employees
to provide an acceptable proof of vaccination status, including whether
they are fully or partially vaccinated. As discussed in Summary and
Explanation (Section VI. of this preamble), acceptable proof of
vaccination status is: (i) The record of immunization from a health
care provider or pharmacy; (ii) a copy of the COVID-19 Vaccination
Record Card; (iii) a copy of medical records documenting the
vaccination; (iv) a copy of immunization records from a public health,
state, or tribal immunization information system; or a copy of any
other official documentation that contains the type of vaccine
administered, date(s) of administration, and the name of the health
care professional(s) or clinic site(s) administering the vaccine(s). A
signed and dated employee attestation is acceptable in instances when
an employee is unable to produce proof of vaccination. Given the
attestation option, there are no technological barriers to the
provision for proof of vaccination status. As discussed below, many
employers requiring proof of vaccination have successfully implemented
such policies even without allowing the flexibility of the attestation
option.
The employer must maintain a record and a roster of each employee's
vaccination status. This information is subject to applicable legal
requirements for confidentiality of medical information. These records
must be preserved while the ETS is in effect. OSHA is not aware of any
technological challenges that the large employers covered by this ETS
would face with respect to collecting and maintaining records. This is
a performance-based requirement, meaning that employers have the
flexibility to structure their systems to fit within current systems,
such as those relating to personnel records, tax records, and other
sensitive or confidential records gathered and maintained by large
employers.
A number of the surveys discussed above also show that most
employers with vaccine mandates require proof of vaccination. For
example, ASU WEF workplace COVID-19 survey from fall 2021 found that
60% of employers that required vaccinations also required proof of
vaccination from employees. The NSC study from June 2021 found that 45%
of employers with COVID-19 vaccination requirements required proof of
vaccination, such as submitting a copy of the COVID-19 vaccination
card. An additional 30% of employers surveyed verify employee
vaccination status through self-reporting based on the honor system.
Additionally, a large-scale survey conducted by the Willis Towers
Watson consulting firm between August 18 and 25, 2021, showed that a
majority of employers currently track their employees' vaccination
status. Nearly one thousand employers responded to this survey, and
they collectively employ 9.7 million workers from industries across the
public and private sectors including manufacturing, general services,
wholesale and retail, IT and telecom, healthcare, financial services,
energy and utilities, and public sector and education (Willis Towers
Watson, June 23, 2021). Nearly six in 10 (59%) currently track their
workers' vaccination status and another 19% are planning or considering
doing so later this year. A majority (62%) of those employers who
currently track their workers' vaccination status require proof of
vaccination, such as CDC vaccination cards, while 36% rely on employees
to self-report (Willis Towers Watson, September 1, 2021).
Other evidence in the record also supports the feasibility both of
gathering proof of vaccination and determining employees' vaccination
status. Many large employers with vaccination policies require
employees to submit proof of vaccination. For example, Tyson Foods
requires employees to submit proof of vaccination to Tyson
Foods Vaccination Verification Program in order to qualify for the
company's vaccination incentive (Tyson Foods, August 3, 2021).
Similarly, Capital One bank requires all employees, contractors,
vendors, and visitors to Capital One facilities to show proof of
vaccination. (Capital One, August 11, 2021). The International Union of
Painters and Allied Trades (IUPAT), which represents 140,000
craftspeople in the U.S. and Canada and has implemented vaccine
requirements for its members, also requires all of its own non-
bargaining unit office and field employees to show proof of
vaccination. (IUPAT, May 10, 2021).
CVS Health, a health conglomerate with more than 300,000 employees,
including more than 40,000 physicians, pharmacists, nurses and nurse
practitioners, has mandated COVID-19 vaccination for its nurses,
pharmacists and other employees who interact with patients and requires
proof of vaccination for those employees (CVS Health, August 23, 2021).
The surveys and employer policies reviewed by OSHA all support the
agency's finding that it is feasible for employers to determine their
employees' vaccination status and collect proof of vaccination.
III. Providing Support for Vaccination
Paragraph (f) of the ETS requires employers to support COVID-19
vaccination for each employee by providing a reasonable amount of time
to each employee for vaccination and reasonable time and paid sick
leave to each employee for side effects experienced following
vaccination. The feasibility of paying for the time is addressed in
OSHA's economic analysis.
This technological feasibility determination focuses on whether
employers would encounter obstacles in implementing payment policies
that would make this requirement infeasible for the large employers
covered by this ETS. OSHA has determined that there are no such
obstacles. Most significantly, OSHA has already required this type of
system for employers covered by the Healthcare ETS and nearly four
months after that ETS took effect, OSHA is not aware that employers
covered by that ETS experienced any technological compliance
difficulties with respect to that requirement. In addition, many
employers have already implemented policies such as those required to
comply with this new ETS as a way of incentivizing employee
vaccination. For example, the ASU WEF workplace COVID-19 survey from
fall 2021 found that 60% of employers surveyed offered incentives for
employees to be vaccinated. These incentives ranged from additional
paid time off, cash, the ability to bypass regular testing and/or daily
health screening requirements, and gifts. Eighteen percent of surveyed
employers already provide additional time off for COVID-19 vaccination.
Moreover, the NSC survey found that 86% of surveyed organizations had
implemented policies such as paid time off, assistance with scheduling
and transportation, and/or onsite vaccination.
OSHA's review of plans and best practice documents from the HAA
registry and from other publicly-available sources also inform OSHA's
finding that it is feasible for large employers to support employee
vaccination (HAA, October 10, 2021). As part of this review, OSHA
analyzed the ways that employers are currently supporting employee
vaccination. One employer in the restaurant industry, the Fifty/50
Group, a Chicago-based restaurant group comprised of 14 establishments
that requires employees to be fully vaccinated, offers paid time off
for anyone getting a vaccine or feeling the mild after-effects. (Fifty/
50 Group, May 18, 2021). Another employer in the animal slaughtering
and processing industry, Tyson Foods, requires COVID-19 vaccinations
for its U.S. workforce and also offers $200 and up to four hours of
regular pay if employees are vaccinated outside of their normal shift
or through an external source (Tyson Foods, August 3, 2021). In
addition, Tyson Foods supports onsite vaccination events in
collaboration with local health departments and healthcare providers to
improve accessibility to vaccination. Tyson Foods has hosted more than
100 vaccination events at its locations across the country.
The evidence in the record demonstrates that many employers are
already offering the types of vaccination support required by paragraph
(f). Combined with OSHA's previous finding for a similar provision in
the Healthcare ETS and the lack of compliance difficulties reported
while that ETS has been in effect, OSHA therefore finds this
requirement is technologically feasible.
IV. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
Paragraph (g) of the ETS requires employers to ensure that
employees who are not fully vaccinated and who report at least once
every seven days to a workplace where other individuals such as
coworkers or customers are present are: (1) Tested for COVID-19 at
least once every seven days; and (2) provide documentation of the most
recent COVID-19 test result to the employer no later than the seventh
day following the date the employee last provided a test result.
Employers must also ensure that employees who are not fully vaccinated
and do not report during a period of seven or more days to a workplace
where other individuals are present are: (1) Tested for COVID-19 within
seven days prior to returning to the workplace; and (2) provide
documentation of that test result upon return to the workplace.
Employees who are not fully vaccinated must be tested with a COVID-
19 test, which is a test for SARS-CoV-2 that is: (i) Cleared, approved,
or authorized, including in an Emergency Use Authorization (EUA) by the
U.S. Food and Drug Administration (FDA) to detect current infection
with the SARS-CoV-2 virus (e.g., a viral test); (ii) administered in
accordance with the authorized instructions; and (iii) not both self-
administered and self-read unless observed by the employer or an
authorized telehealth proctor. Examples of tests that satisfy this
requirement include tests with specimens that are processed by a
laboratory (including home or on-site collected specimens which are
processed either individually or as pooled specimens), proctored over-
the-counter tests, point of care tests, and tests where specimen
collection is either done or observed by an employer.
COVID-19 testing has become more widely available throughout the
pandemic and as of September 2021, the FDA has authorized approximately
250 tests and collection kits that diagnose current infection with the
SARS- CoV-2 virus and may be acceptable under the ETS (FDA, September
10, 2021), and by October 1, 2021, the number of EUAs issued had grown
to 324 (FDA, October 1, 2021). The ETS permits compliance through use
of a wide range of FDA-authorized tests that are readily available, so
there is little doubt that testing itself is technologically feasible.
This technological feasibility analysis therefore focuses on
whether testing will continue to be readily available in quantities
sufficient to meet the potential increase in testing demand while this
ETS is in place. Given the wide variety of tests that can be used to
comply with this ETS and OSHA's review of information about the
existing manufacturing and distribution capabilities of test
manufacturers, the agency does not anticipate feasibility issues
related to ensuring that
employees can get access to one of the acceptable tests within the time
frames required by the ETS.
a. Brief Overview of Testing and Administration
COVID-19 tests that are cleared, approved, or authorized, including
in an Emergency Use Authorization (EUA), by the FDA to detect current
infection with the SARS-CoV-2 virus (e.g., a viral test) satisfy the
ETS. FDA-cleared, approved, or authorized molecular diagnostic tests
and antigen tests are permitted under the ETS when used as authorized
by the FDA and with a Clinical Laboratory Improvement Amendments of
1988 (CLIA) certification when appropriate. As described in the Summary
and Explanation for paragraph (g) (Section VI.G. of this preamble),
NAATs are a type of molecular test that detect genetic material. As of
October 14, 2021, the FDA had issued EUAs for 264 molecular COVID-19
tests including tests specified to be used ``with certain conditions of
authorization required of the manufacturer and authorized
laboratories'', 81 of which are authorized for home collection.
Additionally, the FDA has issued EUAs for 2 OTC molecular COVID-19 test
kits available without a prescription (FDA, October 14, 2021b).
NAATs, such as real-time reverse transcription-polymerase chain
reaction (RT-PCR), have greater accuracy than antigen tests. However,
most FDA-authorized NAATs need to be processed in a laboratory
certified under the Clinical Laboratory Improvement Amendments of 1988
(referred to as a ``CLIA-certified laboratory'') with variable time to
results (~1-2 days). While the NAAT test is a more reliable test, the
antigen test is faster and less expensive.
An antigen test is an in vitro diagnostic test used to detect
active SARS-CoV-2 infection. As of October 14, 2021, the FDA had issued
37 EUAs for COVID-19 antigen tests, including eight EUAs for over-the-
counter (OTC) antigen tests that can be used without a prescription
(FDA, October 14, 2021a).
Administration of an antigen test that meets the definition of
COVID-19 test under this ETS falls into one of several categories: OTC
employee self-tests that are observed by employers or authorized
telehealth proctors; point-of-care (POC) or OTC tests performed by
employers with a CLIA certificate of waiver; and other FDA cleared,
approved, or authorized antigen tests that are analyzed in a CLIA
certified laboratory setting (FDA, October 14, 2021a). The FDA has
authorized POC tests that can be used at a place of employment when the
facility is operating under a CLIA certificate of waiver. A CLIA
certificate of waiver can be issued by CMS and may, when consistent
with FDA's authorization, allow a laboratory to run a SARS-CoV-2 test
outside a high or moderate complexity traditional clinical laboratory
setting (CDC, September 9, 2021). In accordance with the CLIA
certificate of waiver, the laboratory or POC testing site must use a
test authorized for that location, like an FDA EUA POC test, and must
adhere to the authorized test instructions to avoid human error.
Certain COVID-19 antigen diagnostic tests can be analyzed on-site
(where the person took the nasal swab) when that facility is operating
under a CLIA certificate of waiver, while others must be analyzed in a
CLIA certified high or moderate complexity laboratory setting. Some
COVID-19 antigen diagnostic tests are authorized for use at home,
without the need to send a sample to a laboratory. Antigen tests
generally return results in approximately 15-30 minutes. The CDC
provides training materials created by test manufacturers for POC
antigen testing and reading of results for SARS-CoV-2 (CDC, July 8,
2021).
COVID-19 antigen diagnostic tests are found at physician offices;
urgent care facilities; pharmacies, such as CVS or Walgreens; school
health clinics; long-term care facilities and nursing homes; temporary
locations, such as drive-through sites managed by local organizations;
and other locations across the country (CDC, July 8, 2021; CVS Health,
October 2021; Walgreens, October 8, 2021). The availability of
government-offered antigen tests varies by state, and may be free or
subsidized and accessible without a prescription or physician note
(RiteAid, October 2021; Walgreens, October 2021; HHS, June 11, 2021).
The Department of Health and Human Services (HHS) provides a publicly-
available list of community-based testing locations in each state that
offer free COVID-19 testing for insured and uninsured residents (HHS,
August 17, 2021). Pharmacies and other locations often provide antigen
tests by appointment, although some will allow testing for walk-ins
(CVS Health, September 2021; Walgreens, October 8, 2021). COVID test
kits are currently available from several on-line retailers (Amazon,
October 12, 2021).
b. Testing Frequency
The ASU WEF survey data also supports OSHA's finding that the
requirement for employees who are not fully vaccinated to be tested at
least every seven days is feasible. The ASU WEF found that 73% of
survey surveyed employers (797 employers) had testing policies for
their workforce, and 76% of those employers had implemented mandatory
testing requirements. Additionally, 25% of employers with testing
polices had implemented requirements for routine testing of a portion
of or the entire workforce, and 41% no longer require testing for fully
vaccinated employees. Of the employers that test employees, 27% of
those perform viral testing daily and 46% perform viral test once a
week. Finally, 38% of companies exclusively administer polymerase chain
reaction (PCR) tests (PCR tests are a type of NAAT), 17% exclusively
administer antigen tests, and 45% administer both. Companies administer
a range of COVID-19 tests and conduct testing at a variety of locations
(some companies use more than one location). Forty-two percent of
companies test workers at health testing laboratories, 35% test onsite
at work, 28% test at hospitals, 23% test at retail pharmacies, 13% test
at universities, 9% test at home to be sent a lab for evaluation, and
5% test at home for immediate results (ASU WEF, September 2021).
OSHA also evaluated evidence of employers' current testing efforts
by reviewing existing COVID-19 practices developed by employers, trade
associations, and other organizations. Based on its review, OSHA
concludes that it is feasible for most covered employees (and therefore
their employers) to be tested in compliance with the ETS requirements
for frequency of testing.
OSHA notes that there are several options for large employers to
consider if they want to help facilitate testing for employees who are
not vaccinated. Delta Airlines, for example, currently requires weekly
COVID-19 testing for all of its employees who are not vaccinated, and
the company has engaged the Mayo Clinic Laboratories to help design the
employee testing program, assist in administering diagnostic and
serology tests, and analyze the results to determine broader trends and
provide recommendations to Delta's existing policies and procedures
(Mayo Clinic Laboratories, June 30, 2020). Delta Airlines also operates
onsite testing in cities with large employee populations including
Atlanta, Minneapolis, and New York. It recently extended an at-home
specimen collection option to all U.S. employees, through which Quest
Diagnostics will send self-collection kits directly to an employee's
doorstep upon request and support complete laboratory confirmation for
results (Delta, August 25, 2021).
c. Availability of COVID-19 Tests
In the spring and early summer months of 2021, demand for tests
decreased as vaccinations began to increase and the number of COVID-19
cases declined before the Delta surge and some manufacturers slowed
production of COVID-19 tests. However, the number of tests performed
daily has grown considerably over the summer due to the Delta Variant
surge and re-openings of workplaces and schools. In parallel with the
Delta surge, COVID-19 testing has increased from a daily average of
about 450,000 in early July 2021 to about 1.8 million by mid-September
2021, or roughly 12.6 million per week (JHU, October 8, 2021). This
data does not include any self-administered OTC tests, which will be
discussed below.
OSHA's review of the evidence shows that the increasing rate of
production of COVID-19 tests is more than adequate to meet rising
demand related to compliance with the ETS testing option before the 60-
day delayed testing compliance date (see paragraph (m)(2)(ii)). This
determination is largely based on the number of tests with FDA EUAs
actively being produced through the National Institutes of Health (NIH)
Rapid Acceleration of Diagnostics (RADx) initiative described below.
According to the Johns Hopkins University of Medicine Coronavirus
Resource Center, the total tests administered in August 2021 was
approximately 44.4 million (or approximately 11.1 million per week).
Id. During that same month, the total tests produced by the NIH RADx
contracts was approximately 121 million (which would average to 30.25
million per week), resulting in a substantial surplus of available
tests (NIBIB, September 28, 2021). As discussed in Economic Analysis,
Section IV.B. of this preamble, Table IV.B.8, OSHA estimates that as
many as 7.2 million tests may be administered weekly under this
standard; however, 7.2 million is almost certainly an overestimate
because it does not exclude employees who are already required to be
tested by their employers and would continue to be tested at the same
frequency after the ETS. Even if testing is increased by 7.2 million
tests per week because of the ETS, that would still mean a surplus of
nearly 12 million tests per week beyond what would be need to continue
at current testing levels with the addition of ETS-related tests (30.25
- 11.1 - 7.2 = 11.95 million surplus per week).
The total number of tests administered during June, July, and
August 2021, the period of the summer including the Delta Variant surge
and other reasons for substantial testing increases such as re-opening
of schools, was approximately 87 million tests, an average of
approximately 6.7 million per week (JHU, October 8, 2021). During that
period, more than 400 million COVID-19 tests were produced through the
NIH RADx initiative, or roughly 33 million per week. OSHA anticipates
that this surplus of tests will continue to increase the availability
of tests that can be used to comply with the ETS.
The data from the Johns Hopkins Coronavirus Resource Center is
collected from state and county government sources, so it does not
include any self-administered OTC tests. Additionally, while all states
report PCR testing, not all states report antigen testing.
Nevertheless, the data from Johns Hopkins Coronavirus Resource Center
is the best available evidence from which to estimate the total number
of tests administered during a given period of time. Even though the
number of administered tests reported through the Johns Hopkins
Coronavirus Resource Center does not include unreported OTC tests, the
NIH RADx program data shows a large surplus and sufficient additional
COVID-19 test capacity relative to the number of administered tests
reported. Additionally, the NIH RADx program will further allow for
increased test distribution through retail markets and will address any
increase in demand due to companies that may stockpile tests. This
increased availability will strengthen test capacity, further enabling
compliance with the ETS testing provision (NIBIB, September 28, 2021).
OSHA has determined that even with an estimated additional 7.2 million
tests administered weekly due to the ETS (see Economic Analysis
(Section IV.B. of this preamble)), there are sufficient COVID-19 tests
available to allow for both employers and employees to obtain COVID-19
tests through a variety of retail sources (e.g., local pharmacies, on-
line purchasing as discussed above).
Determinations of testing capacity are aggregate measures of
domestic and global market and supply chains. Throughout the pandemic,
diagnostic testing capacity has been stressed by the increased demand,
as some products that are part of a global market cannot adapt by
simply increasing manufacturing in one country (e.g., laboratory
instruments), and other products manufactured domestically require
capital investments to address rising demands (e.g., extraction kits)
(CRS, February 25, 2021). As discussed below, because of the
substantial investments made, OSHA projects that the diagnostic testing
capacity can meet the increased demand due to this ETS.
OSHA evaluated multiple projections of current and future testing
capacity and determined that projections related to the NIH initiatives
discussed below are the most reliable estimates of current and future
testing capacity for its technological feasibility assessment. Test
manufacturers receiving NIH, FDA, and Biomedical Advanced Research and
Development Authority (BARDA) (a component of HHS) funding as part of
these programs undergo a submission and authorization process where
their production capacity and pipeline are assessed and production
quantities are validated. As explained below, as of August 2021, the
NIH data indicates testing capacity stands at about 30 million tests
per week, and capacity continues to grow (NIBIB, September 28, 2021).
OSHA notes that this number underestimates the total number of tests
available each week, as it only includes companies that have received
funding for tests and testing supplies through the NIH initiatives
described below.
The NIH has identified constraints on testing capacity as an area
of focus and investment since the beginning of the COVID-19 pandemic,
and OSHA examined potential constraints on testing capacity as part of
its feasibility analysis. As described below, massive investments in
testing capabilities, particularly in underserved areas, have largely
mitigated issues with the availability of COVID-19 tests. Further,
testing capacity continues to grow as new tests are developed and
brought to market and manufacturers can ramp up supply to meet any
future testing demands if need be.
The FDA has authorized more than 320 tests and collection kits that
diagnose current infection with the SARS-CoV-2 virus and may be
acceptable under the ETS (FDA, October 1, 2021). Among other criteria,
the standard allows for the use of tests with specimens that are
processed by a CLIA certified laboratory (including home or on-site
collected specimens which are processed either individually or as
pooled specimens), proctored over-the-counter tests, point of care
tests, and tests where specimen collection and processing is either
done or observed by an employer. As explained above, many employers
across various industry sectors have already implemented policies for
onsite testing. The use of FDA-authorized POC tests by these employers
would be compliant with the testing provision of the ETS if the entity
administering the test holds a CLIA
certificate as required by the EUA. COVID-19 OTC tests that are both
self-administered and self-read by employees do not satisfy the testing
requirement unless observed by the employer or an authorized telehealth
proctor. In the event that the employer is merely observing the
employee conduct a test, a CLIA certificate would not be needed.
There have been extensive investments, including by the federal
government, to help ensure that COVID-19 tests are widely available.
Section 2401 of the American Rescue Plan appropriated $47,800,000 to
the Secretary of the HHS, to remain available until expended, to carry
out activities to detect, diagnose, trace, and monitor SARS-CoV-2 and
COVID-19 infections and related strategies to mitigate the spread of
COVID-19. Funds were made available to implement a national testing
strategy; provide technical assistance, guidance, support, and awards
grants or cooperative agreements to State, local, and territorial
public health departments; and support the development, manufacturing,
procurement, distribution, and administration of tests to detect or
diagnose SARS-CoV-2 and COVID-19; and establish federal, state, local
and territorial testing capabilities.
On April 29, 2020, the NIH established the RADx initiative with a
$1.5 billion investment. The RADx initiative has used this funding to
speed development of rapid and widely-accessible COVID-19 testing (NIH,
April 29, 2020). On October 6, 2020, the NIH and BARDA established the
RADx Technology (RADx-Tech) and RADx Advanced Technology Platforms
(RADx-ATP) programs to speed innovation in the development,
commercialization, and implementation of technologies for COVID-19
testing specifically for late-stage scale-up projects. Through the RADx
Tech and RADx-ATP programs, the NIH and BARDA have awarded a total of
$476.4 million in manufacturing expansion contracts supporting a
combined portfolio of 22 companies in the U.S. (NIH, October 6, 2020).
These programs have significantly increased testing capacity
throughout the country. Since being established, RADx has worked
closely with the FDA, the CDC, and BARDA to move more advanced
diagnostic technologies swiftly through the development pipeline toward
commercialization and broad availability. On April 28, 2021, the
Institute of Electrical and Electronic Engineers (IEEE) dedicated a
special issue in the Journal of Engineering in Medicine and Biology
exploring the innovative structure and operation of the RADx Tech
program and determined that the initiatives had succeeded in
dramatically increasing COVID-19 testing capacity in the United States.
The IEEE report found that the RADx Tech/ATP programs, in conjunction
with BARDA and the FDA, had streamlined and bolstered the national
COVID-19 testing capacity. At the time of the report, the RADx Tech/ATP
programs had increased the number of testing makers to 150 companies
that, as a result of the NIH/BARDA investments, had the capacity to
produce up to 1.9 million tests per day (IEEE, April 28, 2021).
The NIH RADx-TECH/ATP initiative entered its second phase on
September 28, 2021, and at that time the supported companies had
collectively produced over 500 million tests, received 27 FDA
authorizations, and developed the first OTC COVID-19 test for use at
home. These September 2021 investments are supporting late stage
development of innovative point-of-care and home-based tests, as well
as improved clinical laboratory tests that will increase the capacity
of testing in the U.S. A full list of active contracts and supported
U.S. COVID-19 testing manufacturers can be found on the NIH RADx-TECH/
ATP programs: Phase 2 awards (NIBIB, October 14, 2021).
The following example shows the NIH RADx EUA pipeline process. On
May 9, 2020, the FDA authorized the first EUA for a COVID-19 antigen
test, a new category of tests for use in the ongoing pandemic. Quidel
was awarded a contract under the NIH RADx TECH/ATP phase 1 initiative
for the Sofia 2 SARS Antigen FIA for use in high and moderate
complexity laboratories certified by CLIA, as well as for point-of-care
testing by facilities operating under a CLIA certificate of waiver
(FDA, May 9, 2020). On July 31, 2020, Quidel announced that it had
received a contract for $71 million under the NIH RADx TECH/ATP
program, phase 1, to accelerate the expansion of its manufacturing
capacity for production of the SARS-CoV-2 rapid antigen test and
quickly exceeded that capacity (Quidel Corp., July 31, 2020). On March
31, 2021, the FDA then authorized a second EUA from Quidel under
contract with the NIH RADx initiative for the QuickVue At-Home OTC
COVID-19 Test, another antigen test where certain individuals can
rapidly collect and test their sample at home, without needing to send
a sample to a CLIA certifed laboratory for analysis (FDA, March 31,
2021). Furthermore, based on the success of the Quidel for the Sofia 2
SARS Antigen FIA increasing production capacity, the NIH granted
another $70 million contract for manufacturing Capacity Scale-Up for
Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs on June 11, 2021
(FDA, June 11, 2021).
The RADx-TECH/ATP initiative maintains a dashboard of manufacturer
testing data from supported U.S. firms. OSHA reviewed the data
available on the dashboard as part of its determination of feasibility.
In August 2021, the data showed that U.S. manufacturers supported by
the NIH RADx-TECH/ATP were producing approximately 30 million tests per
week (NIBIB, September 28, 2021).
While consumers in some parts of the country have encountered
difficulty obtaining rapid at-home tests, on October 4, 2021, the FDA
granted EUA for the ACON Laboratories Flowflex COVID-19 Home Test,
which is anticipated to double rapid at-home testing capacity in the
United States within weeks (and well before compliance dates for
testing required by this ETS) (FDA, October 4, 2021). By the end of the
2021 (ahead of the paragraph (g) compliance date), the manufacturer
plans to produce more than 100 million tests per month and plans to
produce more than 200 million tests per month by February 2022 (FDA,
October 4, 2021). On October 6, 2021, the Administration announced a
plan to buy $1 billion worth of rapid at-home COVID-19 tests; this
purchase, coupled with the October 4 authorization of the Flowflex
COVID-19 test, is expected to increase the number of available at-home
COVID-19 tests to 200 million per month by December 2021 (Washington
Post, October 6, 2021).
These investments have had a pronounced impact on the availability
of testing and employers' use of testing in the workplace. ASU's recent
report, How Work has Changed: The Lasting Impact of COVID-19 on the
Workplace, ascribed the jump in the percentage of employers that test
their employees from 17% in the fall of 2020 to 70% in the fall of 2021
in large part to the increased availability of testing. In particular,
the report noted that by the spring of 2021, ``it became relatively
easy to acquire tests and hire testing service providers. There are
more labs and companies with EUA's and most have enough capacity that
there are few shortages.'' (ASU WEF, September 2021).
Moreover, to ensure a broad, sustained capacity for COVID-19 test
production, multiple COVID-19 test manufacturers have been mobilized by
authority of the Defense Production Act. Under the Administration's
plan to increase COVID-19 testing, the federal
government will directly purchase and distribute 280 million- rapid
point-of-care and over-the-counter at-home COVID-19 tests, sending 25
million free at-home rapid tests to community health centers and food
banks. These actions will provide tests for use by communities to build
adequate stockpiles, as well as the sustained production to be able to
scale up production as needed in the future. Additionally, to ensure
convenient access to free testing, 10,000 pharmacies will be added to
the Department of Health and Human Services free testing program.
In response to rising demands for testing, U.S. manufacturers have
increased production of COVID-19 test kit, reagents, and supplies.
Advanced Medical Technology Association (AdvaMed), a trade group for
testing manufacturers, reported that its members are ramping up
production of rapid point-of-care test supplies to meet demand and that
laboratory-based testing capacity for test confirmation is strong.
AdvaMed has created a national COVID-19 Diagnostic Supply Registry of
COVID-19 test manufacturers that support state and federal governments
in their pandemic responses. Registry participants are thirteen leading
diagnostic manufacturers whose tests together comprise approximately
75-80% of the COVID-19 in vitro diagnostic devices (IVD) on the market
in the U.S. While these manufacturers produce a majority of molecular
COVID-19 tests, they do not produce a majority of the total COVID-19
tests manufactured. These COVID-19 test manufacturers collectively
shipped approximately 3.8 million tests in July 2021, 8.2 million tests
in August 2021, and 9.4 million molecular tests for the week ending
September 4th, 2021 (AdvaMed, September 10, 2021). While these figures
are not representative of the total weekly testing capacity in the
U.S., this data demonstrates that testing capacity has grown
significantly over the past few months and reflects the success
manufacturers have had in ramping up production of tests.
While current test availability is sufficient to meet the increased
testing demands due to the ETS, OSHA is also confident that the RADx-
TECH/ATP initiatives will continue to spur testing capacity and growth.
The RADx-TECH/ATP initiatives have focused on moving test makers'
products through the late stage pipeline and securing FDA authorization
for entry into the market. So far, there have been 27 such
authorizations. As of September 2021, there were 824 eligible late-
stage scale up proposals from various test makers up for review for
NIH/BARDA funding. Furthermore, 517 of these submissions are for the
authorization and production of multiple types of COVID-19 tests
including one or more of the following: Blood, sputum, nasal swab, oral
swab, fecal, saliva, or other types. OSHA considers this to be further
support for its determination that testing capacity will continue to
grow and that increased COVID-19 testing supplies are on the horizon
(NIBIB, September 28, 2021).
Based on data from the Johns Hopkins Coronavirus Resource Center,
which examined publicly-available data from multiple sources,
approximately 12.4 million tests were conducted during the week of
August 26-September 2, 2021. As noted earlier, in the economic analysis
of this ETS, OSHA projects testing rates to increase by approximately
7.2 million tests per week starting 60 days after publication of the
ETS. As described above, many employers are currently testing their
workforce. This 7.2 million is almost certainly an overestimate because
it does not exclude employees who are already required to be tested by
their employers and would continue to be tested at the same frequency
after the ETS. The data reviewed by OSHA on the RADx-TECH/ATP Dashboard
shows that the manufacturers supported by the initiative are producing
approximately 30 million tests per week, and capacity continues to
grow. As explained above, it is expected that roughly 50 million at-
home COVID-19 tests will be available each week by December 2021. OSHA
therefore finds that there are (and will continue to be) sufficient
COVID-19 tests available to meet the anticipated demand related to
compliance with paragraph (g) by the 60-day delayed compliance date.
d. Availability of COVID-19 Test Supplies
OSHA has also analyzed the availability of COVID-19 test supplies
for use by COVID-19 test kit manufacturers, diagnostic laboratories,
and determined that there are sufficient supplies to allow compliance
with the ETS testing option. The COVID-19 pandemic and recent Delta
Variant surge have caused some disruptions in the availability of
testing supplies such as swabs, viral transport medium, RNA extraction
kits, serology consumables, diagnostic reagents, plastic consumables,
and diagnostic instruments. The COVID-19 testing supply market is
driven by the need to rapidly screen large segments of the population
and deliver test results. The data presented throughout this assessment
has shown demand for laboratory COVID-19 tests is rising across the
country.
Testing for COVID-19 involves many different components that are
manufactured, transported, and used independently (e.g., bulk solvents,
extracting reagents, packaging) or semi-independently (e.g., test
kits). Most of the supplies used in COVID-19 testing are disposable,
requiring a constant sustained capacity for new supplies. Some
distribution channels move supplies directly to medical and laboratory
end-users and others move supplies through distributors. In either
case, the combination of increased testing demand and the established
supply chains indicate that testing kits will be available in
sufficient quantities throughout the country, including in rural areas
where large employers may be located.
There have been substantial investments from federal and state
programs and private industry to stimulate the production and
distribution of testing supplies to bolster testing capacity across the
country. Many products, such as swabs and reagents for RNA extraction
kits, exhibited rising demand and, at some point during the pandemic,
were subject to shortages that threatened continued testing capacity.
For example, there was only one domestic manufacturer of medical grade
flocked swabs, Puritan Medical Products Company of Guilford, Maine, and
the company's pre-pandemic capacity was insufficient to meet demand of
increased testing in the early period of the COVID-19 pandemic (Puritan
Products, April 20, 2020). On July 29, 2020, the Department of Defense
(DOD), in coordination with the Department of Health and Human
Services, awarded $51.15 million to Puritan to expand industrial
production capacity of flock tip testing swabs (DOD, July 31, 2020). On
March 26, 2021, Puritan was awarded another $146.77 million to increase
the company's total production capacity to 250 million foam tip swabs
per month at its Tennessee facility by February 2022 (DOD, March 29,
2021).
Other private sector companies were mobilized to change the
products they manufactured to accelerate production of COVID-19 test
components, such as swabs, reagents, and solvents for RNA extraction
kits. For example, Microbrush, a U.S.-based manufacturer of sterile
applicators for the dental industry, began production of a
nasopharyngeal test swab to meet the growing demand for COVID-19
testing requirements in July 2020. The Microbrush test swabs are
sterilized and individually packaged in a medical-
grade pouch intended for nasopharyngeal sample collection such as in
dental procedures and also COVID-19 testing (Microbrush, July 1, 2020).
RNA extraction kits are used by the majority of NAAT protocols.
These kits are sets of consumable plastic laboratory materials (small
centrifuge tubes, filters, and collection vials) and chemical reagents
(solutions for breaking the virus apart and purification) assembled by
a manufacturer. Each kit has enough materials to process several dozen
samples. The use of RNA extraction kits is not exclusive to COVID-19
testing, meaning that a market existed pre-COVID-19, and manufacturers
were able to adapt to fluctuations in demand spurred by the pandemic.
There are multiple companies with facilities in the United States
that produce RNA extraction kits for the domestic market that have been
awarded federal grants to increase the supply of COVID-19 test kits and
reagent supplies. For example, in December 2020, the DOD and HHS
identified several key reagents with the potential for supply chain
bottlenecks and awarded a $4.8 million Indefinite Delivery/Indefinite
Quantity contract to Anatrace Products, LLC to support increased
production of key reagents for sample processing; Polyadenylic Acid
(Poly A), Guanidinium Thiocyanate (GTC), and Proteinase K (Pro K) to
process samples (DOD, December 21, 2020). Additionally, QIAGEN (based
in Germany with U.S. manufacturing in Germantown, Maryland) produces
extraction kits for authorized COVID-19 tests and has responded to the
pandemic by scaling their production to around the clock production to
strengthen testing kit capacity (Qiagen, October 2, 2021). On August
23, 2021, DOD, on behalf of and in coordination with HHS, awarded a
$600,000 contract to QIAGEN to expand manufacturing capacity of
enzymatic reagents and reagent kits used in COVID-19 molecular
diagnostic tests, thereby allowing QIAGEN to increase its monthly
production of reagent kits by 7,000 and enzymes by 5,100 milligrams by
the end of February 2022 to support domestic laboratory testing for
COVID-19 (DOD, August 23, 2021).
Additionally, manufacturers of raw materials and solvents for
COVID-19 test kits have implemented strategies to strengthen their
portions of the COVID-19 test supply chain. Millipore Sigma, a large
producer of solvents and raw materials for tests, has created a global
task force to actively evaluate the overall supply chain of products
and key raw material suppliers to mitigate any potential disruption of
COVID-19 testing capacity (Millipore Sigma, October 2021). In light of
the foregoing, OSHA believes that there is sufficient--and increasing--
availability of COVID-19 testing supplies to enable compliance with the
ETS testing option.
e. Sufficiency of Laboratory Capacity
As noted above, a wide range of tests are acceptable under the ETS,
including those that can be observed by employers without laboratory
processing. Moreover, there has been rapid growth in the availability
of OTC tests that do not require laboratory processing. Authorized OTC
tests self-administered by employees and proctored by the employer do
not require a CLIA certificate of waiver.
The Association of Public Health Laboratories (APHL) has conducted
weekly surveys of its membership to monitor their current and projected
capability and capacity to test for COVID-19. Data from this survey is
used to inform HHS, FEMA, CDC, and other federal partners to support
public health laboratory supply and reagent needs. OSHA reviewed the
weekly COVID-19 survey results through the APHL COVID-19 Lab Testing
Capacity and Capability Data Dashboard. The data comes from voluntary
participation in the weekly surveys collected from approximately 100
state, local and territorial public health laboratories (PHLs) and
reported to the CDC. The APHL weekly survey data supports OSHA's
feasibility determination and demonstrates that COVID-19 testing demand
will be met. For example, from August 15, 2021 to September 12, 2021,
the APHL weekly survey data found that 96-100% of PHLs are meeting
their current testing demand since the Delta Variant surge began (APHL,
September 27, 2021).
Laboratory capacity for processing and confirmation of at-home
COVID-19 rapid tests provided by manufacturer retailers such as Walmart
has also increased. Laboratory and diagnostic service providers have
implemented parallel strategies to strengthen laboratory capacity for
confirmation of at-home COVID-19 rapid tests available on the market
for employers and employees to utilize. For example, Quest Diagnostics,
which is the laboratory processing the samples and delivering results
to those tested at Walmart's drive-through and curbside testing sites,
has scaled up laboratory testing capacity and rapid antigen test
inventory should demand increase (Walmart, July 9, 2021). Quest
Diagnostics has added COVID-19 testing platforms in laboratories in
regions where demand is comparatively high and has implemented an
online consumer-initiated test service for individuals and small
businesses to request COVID-19 testing. In August 2021, Quest
Diagnostics began to offer clinician-guided rapid COVID-19 antigen
testing to employers through a guided telehealth visit using a self-
administered, nasal swab antigen test that provides results in 15
minutes that is then shipped to a Quest Diagnostics lab for
confirmation (Quest Diagnostics, September 28, 2021).
Based on the evidence reviewed, OSHA has determined that there is
adequate laboratory capacity to enable compliance with the ETS testing
option.
f. Access to Testing in Underserved Communities
Individuals in underserved communities (including Black, Latino,
and Indigenous and Native American persons, Asian Americans and Pacific
Islanders and other persons of color; members of religious minorities;
lesbian, gay, bisexual, transgender, and queer persons; persons with
disabilities; persons who live in rural areas; and persons otherwise
adversely affected by persistent poverty or inequality) are
disproportionately burdened by the COVID-19 pandemic as many
individuals in these communities are essential workers who cannot work
from home, increasing their risk of being exposed to the virus. Access
to COVID-19 testing in these communities has been identified as
contributing factor to COVID-19 related health disparities in these
communities. For example, the NSC June 2021 survey found that the most
common barrier to testing for rural employers and workers is access to
vaccination and testing sites (NSC, September 2021).
Several federal efforts have recently been implemented to
strengthen testing capabilities in underserved communities. The NIH has
invested heavily to improve COVID-19 testing in underserved communities
throughout the COVID-19 pandemic. On September 30, 2020, the NIH
received nearly $234 million to improve COVID-19 testing for
underserved and vulnerable populations that have been
disproportionately affected by this pandemic and launched the RADx
Underserved Populations (RADx-UP) program (NIH, September 30, 2020).
The RADx-UP program has primary components supported by these NIH
grants to increase availability, accessibility, and acceptance of
testing among underserved and vulnerable populations. The RADx-UP
program also provides overarching support and
guidance on administrative operations and logistics, facilitating
effective use of COVID-19 testing technologies, supporting community
and health system engagement, and providing overall infrastructure for
data collection, integration, and sharing from a coordination and data
collection center (NIH, September 30, 2021). Through the RADx-UP
program, the NIH has continued to support the needs of underserved
populations and is currently funding 70 community-based projects across
the country (NIH, September 30, 2021).
The CDC has also focused its efforts to improve COVID-19 testing in
underserved communities throughout the COVID-19 pandemic. For example,
on September 20, 2021, Maine Health, the largest health care
organization in Maine and also serving northern New Hampshire, was
awarded nearly $1 million for COVID-19 testing in higher risk
communities (Maine Health, September 20, 2021). In March 2021, the CDC
implemented a plan to invest $2.25 billion over two years to address
COVID-19 related health disparities and advance health equity among
populations that are at high-risk and underserved, including racial and
ethnic minority groups and people living in rural areas. Since that
time, the CDC has awarded grants to public health departments to
improve testing capabilities; improve data collection and reporting;
and build, leverage, and expand infrastructure support for testing
(CDC, March 17, 2021). On September 30, 2021, the CDC awarded an $8.1
million grant to the Arizona Center for Rural Health (ACRH) to address
COVID-19 disparities across Arizona by improving the delivery of COVID-
19 testing to rural and underserved communities (ASU CRH, September 30,
2021). A number of other federal and state government agencies have
been expanding support for COVID-19 testing in underserved communities
as well. On June 11, 2021, HHS through the Health Resources and
Services Administration (HRSA) provided $424.7 million in American
Rescue Plan funding to over 4,200 Rural Health Clinics (RHCs) for
COVID-19 testing (HHS, June 11, 2021).
Private industry has also mobilized considerably to increase access
and testing capacity in rural and other underserved communities. The
NSC June 2021 survey found that a common barrier to employers and
employees in rural and other underserved communities is transportation
and access to vaccination and testing sites (NSC, September 2021). In
its final report, the NSC recommended employers in these communities
host on-site vaccinations to increase worker access. Applications for
mobile vaccination are available on most local and state health
department websites (NSC, September 2021; ASU WEF, September 2021).
CVS has collaborated with several organizations, including the
National Medical Association, to increase access to testing in
underserved communities and has developed mobile solutions that allow
health care professionals to bring testing capabilities to businesses
in these communities as they re-open (CVS Health, September 2021).
Walgreens has implemented efforts to increase access in underserved
communities such as rural and/or lower socioeconomic communities as
well, with now more than half of Walgreens testing sites currently
located in areas the CDC has identified as socially vulnerable and
underserved (Walgreens, October 2021). Because of these investments,
OSHA concludes that employers and their employees in underserved
communities, including those in rural areas, will have sufficient
access to COVID-19 tests and will be able to comply with the ETS's
testing requirements for employees who are not fully vaccinated.
V. Management of Confidential Medical Records, Including Employee
COVID-19 Vaccination and Testing Records
The ETS requires employers to maintain a record of each employee's
vaccination status. Employers must also maintain a record of each test
result provided by each employee. These records must be maintained as
confidential medical records and must not be disclosed except as
required or authorized by this ETS or other federal law. The records
are not subject to the retention requirements of 29 CFR
1910.1020(d)(1)(i) but must be maintained and preserved while the ETS
is in effect.
Other OSHA rules have a similar requirement to maintain employee
medical records, which could include vaccination records. See, e.g.,
Bloodborne Pathogens (29 CFR 1910.1030), Respiratory Protection (29 CFR
1910.134), Respirable Crystalline Silica (29 CFR 1910.1053), Beryllium
(29 CFR 1910.1024), Lead (29 CFR 1910.1025), and OSHA's requirements
for employee access to medical and exposure records (29 CFR 1910.1020).
OSHA is not aware of any potential technological feasibility issues
related to recordkeeping.
The requirement under this ETS to maintain records of employees'
COVID-19 vaccination status and COVID-19 test results is similar to
requirements in the aforementioned OSHA standards, and OSHA therefore
concludes that compliance is feasible. Employers subject to the ETS
will be able to comply with the provisions in the ETS using
straightforward recordkeeping systems that are already widely used by
large employers as part of their usual and customary business
practices. OSHA concludes that it is feasible for such employers to
comply with the requirements in the ETS for maintaining records related
to COVID-19 vaccination status and COVID-19 test results.
VI. Other Provisions
There are no technological feasibility barriers related to
compliance with other requirements in the ETS (e.g., face coverings,
employee notification). As explained above, many of the employer plans
and best practice documents reviewed by OSHA indicate that employers
have implemented the measures in these provisions across industry
sectors. OSHA highlights two of the ETS's other requirements below,
which are explored in more depth in other sections of this preamble.
Face Coverings. Paragraph (i) of the ETS requires the
employer to ensure that all employees who are not fully vaccinated wear
a face covering when indoors and when occupying a vehicle with another
person for work purposes, except: (i) When an employee is alone in a
room with floor to ceiling walls and a closed door; (ii) for a limited
time while the employee is eating or drinking at the workplace or for
identification purposes in compliance with safety and security
requirements; (iii) when employees are wearing respirators or face
masks; or (iv) where the employer can show that the use of face
coverings is infeasible or creates a greater hazard. The definition of
face covering allows various different types of masks, including clear
face coverings or cloth face coverings with a clear plastic panel which
may be used to facilitate communication with people who are deaf or
hard-of-hearing or others who need to see a speaker's mouth or facial
expressions to understand speech or sign language respectively. The
types of face coverings permitted under this ETS are widely used and
readily available. The results of the ASU WEF June 2021 survey found
that 30% of employers required face coverings for unvaccinated
employees, which demonstrates that this provision of the ETS is
currently being implemented by a substantial number of employers and is
``capable of being done.'' (ASU WEF, September 2021). OSHA identifies
no technological
feasibility issues with this provision of the ETS.
Notification. Paragraph (h) of the ETS contains COVID-19
notification requirements for both the employer and the employee. Under
this provision, the employer must require each employee to promptly
notify the employer if they receive a positive COVID-19 test or are
diagnosed with COVID-19 by a licensed healthcare provider and must
immediately remove any employee from the workplace who receives a
positive COVID-19 test or is diagnosed with COVID-19 by a licensed
healthcare provider. OSHA identifies no technological feasibility
issues in connection with the ETS's notification requirements. It is
the employer's responsibility to ensure that appropriate instructions
and procedures are in place so that designated representatives of the
employer (e.g., managers, supervisors) and employees conform to the
rule's requirements.
VII. Conclusion
OSHA has determined that complying with this ETS is technologically
feasible for typical firms covered by this standard, at least most of
the time (see Public Citizen v. OSHA, 557 F.3d 165 (3d Cir. 2009); Lead
I, 647 F.2d at 1272; Lead II, 939 F.2d at 990). OSHA reviewed extensive
evidence across industries and did not identify any industry-specific
compliance barriers. Evidence in the record that shows that the written
workplace COVID-19 vaccination policy requiring each employee to be
fully vaccinated against COVID-19 unless they establish and implement a
written policy that permits an employee to choose to be tested for
COVID-19 at least every seven days and wear a face covering is
feasible. In fact, such policies have already been implemented by
hundreds of large companies across industry sectors. OSHA has also
determined that there are sufficient COVID-19 tests available and
adequate laboratory capacity to meet the anticipated increased testing
demand related to compliance with the ETS testing option.
Additionally, the ETS's requirements to determine employee
vaccination status, support employee vaccination by providing time off
for vaccination and time off for recovery, and maintain records of
employee COVID-19 vaccination status and COVID-19 test results are also
technologically feasible. As discussed above, that many employers and
organizations have already implemented such requirements demonstrates
that they are ``capable of being done.'' Moreover, the recordkeeping
requirements in this ETS largely mirror the requirements for the
collection and maintenance of similar employee medical records in
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) and the
Respiratory Protection standard (29 CFR 1910.134). The ETS provides a
flexible compliance option for employers to tailor their procedures and
practices to the needs of their workplace. OSHA finds that employers in
typical firms in all industry sectors can comply with the requirements
of the ETS, and compliance with the ETS is therefore technologically
feasible.
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(2021, September 17). COVID-19 Employer Policies: A Decision Tool
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International Union of Painters and Allied Trades (IUPAT). (2021,
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Johns Hopkins University. (2021, October 8). Coronavirus Resource
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Kaiser Permanente. (2021, August 2). Protecting health and safety
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(Kaiser Permanente, August 2, 2021)
MaineHealth. (2021, September 20). MaineHealth awarded nearly $1M by
National Institutes of Health to study COVID-19 testing in higher
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(Maine Health, September 20, 2021)
Mayo Clinic Laboratories. (2020, June 30). Mayo Clinic experts to
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(Microbrush, July 1, 2020)
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October 2021)
National Academy for State Health Policy (NASHP). (2021, October 1).
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National Institutes of Health (NIH) National Institute of Biomedical
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2021)
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National Institutes of Health (NIH). (2020, September 30). NIH to
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National Institutes of Health (NIH). (2020, April 29). NIH mobilizes
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National Safety Council (NSC). (2021, May 17). SAFER: Safe Actions
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2021)
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Year in Review, and What's Next. https://www.nsc.org/workplace/safety-topics/safer/state-of-the-response-state-actions-to-address-the. (NSC, September 2021)
Puritan Products. (2020, April 20). Puritan Blog: Puritan at the
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Qiagen. (2021, October 2). COVID-19 Latest News. https://www.qiagen.com/us/customer-stories/latest-news-on-the-fight-against-coronavirus. (Qiagen, October 2, 2021)
Quest Diagnostics. (2021, September 28). Quest Diagnostics Media
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Quidel Corporation. (2020, July 31). Press release, Quidel Corp.
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Corp., July 31, 2020)
RiteAid. (2021, October). Free* COVID-19 Testing. https://www.riteaid.com/pharmacy/services/covid-19-testing. (RiteAid,
October 2021)
Sanford Health. (2021, July 22). Sanford Health to require COVID-19
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July 22, 2021)
Trinity Health. (2021, July 8). Trinity Health Announces COVID-19
Vaccine Requirement for All Colleagues. https://www.trinity-
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requirement-for-all-colleagues. (Trinity Health, July 8, 2021)
Tyson Foods. (2021, August 3) Tyson Foods to Require COVID-19
Vaccinations for its U.S. Workforce. https://www.tysonfoods.com/news/news-releases/2021/8/tyson-foods-require-covid-19-vaccinations-its-us-workforce. (Tyson Foods, August 3, 2021)
University of Arizona Center for Rural Health (ASU CRH). (2021,
September 30). ADHS-CDC COVID Disparities Initiative. https://crh.arizona.edu/programs/covid-disparities-initiative. (ASU CRH,
September 30, 2021)
U.S. Department of Defense (DOD). (2021, March 29) DOD Awards
$146.77 Million Contract to Puritan Medical Products to Increase
Domestic Production Capacity of Foam Tip Swabs. https://www.defense.gov/News/Releases/Release/Article/2554073/dod-awards-14677-million-contract-to-puritan-medical-products-to-increase-domes/. (DOD, March 29, 2021)
U.S. Department of Defense (DOD). (2021, July 31). DOD Awards $51.15
Million Undefinitized Contract Action to Puritan Medical Products
Company LLC to Increase Domestic Production Capacity of Flock Tip
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U.S. Department of Defense (DOD). (2021, August 23). DOD Awards $0.6
Million Contract to QIAGEN to Increase Domestic Production Capacity
of COVID-19 Diagnostic Test Kits and Reagents. https://www.defense.gov/News/Releases/Release/Article/2742967/dod-awards-06-million-contract-to-qiagen-to-increase-domestic-production-capaci/.
(DOD, August 23, 2021)
U.S. Department of Defense (DOD). (2021, December 21). DOD Awards
$4.8 Million Indefinite Delivery/Indefinite Quantity to a Calibre
Scientific Subsidiary, Anatrace, to Increase Domestic Production
Capacity of COVID-19 Testing Reagents. https://www.defense.gov/News/Releases/Release/Article/2454163/dod-awards-48-million-indefinite-deliveryindefinite-quantity-to-a-calibre-scien/. (DOD, December 21,
2020)
U.S. Department of Health and Human Services. (HHS). (2021, June
11). HHS Provides $424.7 Million to Rural Health Clinics for COVID-
19 Testing and Mitigation in Rural Communities. https://www.hhs.gov/about/news/2021/06/11/hhs-provides-424-million-to-rural-health-clinics-for-covid-19-testing.html. (HHS, June 11, 2021)
U.S. Department of Health and Human Services (HHS). (2021, August
17). Community based testing sites. https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html. (HHS, August 17, 2021)
Walgreens. (2021, October). Free Drive-Thru COVID-19 Testing for
Ages 3+. https://www.walgreens.com/findcare/covid19/testing?ban=covid_hp_cause2. (Walgreens, October 2021)
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Walmart. (2021, July 9). Supporting COVID-19 Testing. https://corporate.walmart.com/covid19testing. (Walmart, July 9, 2021)
Washington Post. (2021, October 6). White House announces $1 billion
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Willis Towers Watson. (2021, June 23) COVID-19 Vaccination and
Reopening the Workplace Survey press release. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
Watson, June 23, 2021)
Willis Towers Watson. (2021, September 1) Workplace vaccine mandates
expected to accelerate, Willis Towers Watson survey finds. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
Watson, September 1, 2021)
B. Economic Analysis
I. Introduction
This section presents OSHA's estimates of the costs and impacts,
anticipated to result from the COVID-19 Vaccination and Testing ETS, 29
CFR 1910.501. The purpose of this ETS is to address the grave danger of
COVID-19 in the workplace by promoting vaccination, while allowing an
alternative for face covering and testing requirements, and also to
remove COVID-19 positive workers from the workplace regardless of
vaccination status. The estimated costs are based on employers
achieving full compliance with the requirements of the ETS. They do not
include prior costs associated with firms whose current practices are
already in compliance with the ETS requirements. The purpose of this
analysis is to:
Identify the entities/establishments and industries
affected by the ETS;
Estimate and evaluate the costs and economic impacts that
regulated entities/establishments will incur to achieve compliance with
the ETS; and
Evaluate the economic feasibility of the rule for affected
industries.
In this analysis, OSHA is fulfilling the requirement under the OSH
Act to show the economic feasibility of this ETS. This analysis is
different from the cost portion of a regulatory impact analysis
prepared in accordance with Executive Order 12866 in that the agency is
focused only on costs to employers when evaluating economic
feasibility. In a regulatory impact analysis, the costs to all parties
(e.g., employers, employees, and governments) are included. While this
is not the case for an economic feasibility analysis, it does not
necessarily mean that the ETS imposes no costs or burdens on parties
other than employers. For example, the rule imposes certain costs on
employees who choose not to become vaccinated (e.g., for face coverings
and testing. While these costs are not relevant for the purpose of
establishing economic feasibility, these costs would be attributable to
the ETS in a regulatory impact analysis. In addition, these costs are
not mandatory because any employee who does not wish to pay them may
choose to become vaccinated or leave employment (see discussion below
on turnover), after which the costs would not be incurred. Some
employees may also be entitled to a reasonable accommodation that may
avoid additional cost (e.g., telework).
``[T]he Supreme Court has conclusively ruled that economic
feasibility [under the OSH Act] does not involve a cost-benefit
analysis.'' Pub. Citizen Health Research Grp. v. U.S. Dept. of Labor,
557 F.3d 165, 177 (3d Cir. 2009); see also Asbestos Info. Ass'n, 727
F.2d at 424 n.18 (noting that formal cost benefit is not required for
an ETS, and indeed may be impossible in an emergency). The OSH Act
``place[s] the `benefit' of worker health above all other
considerations save those making attainment of this `benefit'
unachievable.'' Cotton Dust, 452 U.S. at 509. Therefore, ``[a]ny
standard based on a balancing of costs and benefits by the Secretary
that strikes a different balance than that struck by Congress would be
inconsistent with the command set forth in'' the statute. Id. While
this case law arose with respect to health standards issued under
section 6(b)(5) of the Act, which specifically require feasibility,
OSHA finds the same concerns applicable to emergency temporary
standards issued under section 6(c) of the Act. An ETS ``serve[s] as a
proposed rule'' for a section 6(b)(5) standard, and therefore the same
limits on any requirement for cost-benefit analysis should apply.
Indeed, OSHA has also rejected the use of formal cost benefit analysis
for safety standards, which are not governed by section 6(b)(5). See 58
FR 16,612, 16,622-23 (Mar. 30, 1993) (``in OSHA's judgment, its
statutory mandate to achieve safe and healthful workplaces for the
nation's employees limits the role monetization of benefits and
analysis of extra-
workplace effects can play in setting safety standards.'').\22\ A
standard must be economically feasible in order to be ``reasonably
necessary and appropriate'' under section 3(8) and, by inference,
``necessary'' under section 6(c)(1)(B) of the OSH Act. Cf. Am. Textile
Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 513 n.31 (1981) (noting
``any standard that was not economically . . . feasible would a
fortiori not be `reasonably necessary or appropriate' '' as required by
the OSH Act's definition of ``occupational safety and health standard''
in section 3(8)); see also Florida Peach Growers, 489 F.2d at 130
(recognizing that the promulgation of any standard, including an ETS,
must account for its economic effect). A standard is economically
feasible when industries can absorb or pass on the costs of compliance
without threatening industry's long-term profitability or competitive
structure, Cotton Dust, 452 U.S. at 530 n.55, or ``threaten[ing]
massive dislocation to, or imperil[ing] the existence of, the
industry.'' United Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1272
(D.C. Cir. 1981) (Lead I). Given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make the showing with the same rigor as in ordinary section
6(b) rulemaking. Asbestos Info. Ass'n/N. Am. v. OSHA, 727 F.2d 415, 424
n.18 (5th Cir. 1984). In Asbestos Information Association, the Fifth
Circuit concluded that the costs of compliance were not unreasonable to
address a grave danger where the costs of the ETS did not exceed 7.2%
of revenues in any affected industry. Id. at 424.
---------------------------------------------------------------------------
\22\ To support its Asbestos ETS, OSHA conducted an economic
feasibility analysis on these terms. 48 FR 51086, 51136-38 (Nov. 4,
1983). In upholding that analysis, the Fifth Circuit said that OSHA
was required to show that the balance of costs to benefits was not
unreasonable. Asbestos Info. Ass'n, 727 F.2d at 423. As explained
above, OSHA does not believe that is a correct statement of the
economic feasibility test. However, even under that approach this
ETS easily passes muster.
---------------------------------------------------------------------------
The scope of judicial review of OSHA's determinations regarding
feasibility (both technological and economic) ``is narrowly
circumscribed.'' N. Am.'s Bldg. Trades Unions v. OSHA, 878 F.3d 271,
296 (D.C. Cir. 2017) (Silica). ``OSHA is not required to prove economic
feasibility with certainty, but is required to use the best available
evidence and to support its conclusions with substantial evidence.''
Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980-81 (D.C. Cir. 1991)
(Lead II); 29 U.S.C. 655(b)(5), (f). ``Courts, [moreover], `cannot
expect hard and precise estimates of costs.' '' Silica, 878 F.3d at 296
(quoting Lead II, 939 F.2d at 1006). Rather, OSHA's estimates must
represent ``a reasonable assessment of the likely range of costs of its
standard, and the likely effects of those costs on the industry.'' Lead
I, 647 F.2d at 1266. The ``mere `possibility of drawing two
inconsistent conclusions from the evidence,' or deriving two divergent
cost models from the data `does not prevent [the] agency's finding from
being supported by substantial evidence.' '' Silica, 878 F.3d at 296
(quoting Cotton Dust, 452 U.S. at 523).
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of the intended regulation and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, and public health and
safety effects; distributive impacts; and equity). Executive Order
13563 emphasized the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
Because of the continued impact of the pandemic on occupational safety
and health, OSHA has prepared this ETS and the accompanying economic
analysis on an extremely condensed timeline. Thus, in light of the
Secretary's conclusion that the COVID-19 pandemic constitutes an
emergency situation, the Secretary has notified OIRA that it is
necessary for OSHA to promulgate this regulation more quickly than
normal review procedures allow, pursuant to E.O. 12866 Sec. 6
(a)(3)(D). OIRA has waived compliance with Sec. 6(a)(3)(B) and (C) for
this economically significant rule.
II. COVID-19 ETS Industry Profile
a. Introduction
In this section, OSHA provides estimates of the number of affected
entities, establishments, and employees for the industries that have
settings covered by this ETS. The term ``entity'' describes a legal
for-profit business, a non-profit organization, or a local governmental
unit, whereas the term ``establishment'' describes a particular
physical site of economic activity. Some entities own and operate more
than one establishment.
Throughout this analysis, where estimates were derived from
available data those sources have been noted in the text. Estimates
without sources noted in the text are based on agency expertise.
b. Scope of the COVID-19 ETS
This ETS applies to all employers with a total of 100 or more
employees at any time this ETS is in effect. However, the requirements
of this ETS do not apply to: (1) Workplaces covered under the Safer
Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for
Federal Contractors and Subcontractors (Contractor Guidance); or (2)
settings where any employee provides healthcare services or healthcare
support services when subject to the requirements of 29 CFR 1910.502
(i.e., the Healthcare ETS). Furthermore, the requirements of this ETS
do not apply to the employees of covered employers: (1) Who do not
report to a workplace where other individuals, such as coworkers or
customers, are present; or (2) while working from home; or (3) who work
exclusively outdoors. Based on this scope, employers in nearly every
sector are expected to be covered by this ETS.
OSHA's assumptions may result in an overestimate of the number of
employees affected by the ETS. First, OSHA is not estimating the number
and type of workplaces covered by the Safer Federal Workforce Task
Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors or removing them from the profile of employers affected
by this ETS. OSHA assumes for the purpose of this analysis that
employers covered under the Contractor Guidance will also have
contracts to perform work in workplaces where they are not covered
under that Guidance (i.e., where the employer contracts with an entity
other than the federal government), and so those employers are included
in the scope here.
Second, OSHA estimates that all employers in all private sector
industries are affected by this ETS to some extent. Although this ETS
imposes no compliance burden on employers whose employees work remotely
100 percent of the time, in OSHA's analysis, no employers with 100 or
more employees have all of their employees working remotely 100 percent
of the time (i.e., at least some employees in each affected firm do not
work remotely). Moreover, OSHA's analysis does not take into account
that some employees may engage in part-time telework (i.e., it assumes
that employees either work remotely full-time or do not work remotely
at all). Finally, OSHA's analysis does not fully take into account the
exemption for employees who do not report to a workplace where other
individuals are present, meaning that this analysis may overestimate
the number of employees affected by the rule.
As stated, the requirements of this ETS do not apply to the
employees of covered employers who work
exclusively outdoors. To determine the percentage of employees in
occupations for which the exception is relevant, the agency uses data
from the BLS's 2020 Occupational Requirements Survey (ORS) (BLS, 2020).
This survey looks at various aspects of job requirements. In
particular, the survey lists occupations where workers are outdoors
``constantly,'' which OSHA interprets as being nearly continuously
outdoors. Because the majority of workers who work outdoors
``constantly'' likely work indoors at least some of the time, the
agency judges that no more than 10 percent of the workers who are
primarily outdoors are actually there exclusively. See Table IV.B.1 for
the occupations, the ORS percentages, and final percentages for workers
OSHA estimates are exempt from the scope of this ETS based on the
outdoor work exemption.
[GRAPHIC] [TIFF OMITTED] TR05NO21.000
OSHA's estimate of employees who work exclusively outdoors does not
account for employers who only need to make slight adjustments to their
current work practices to ensure that their employees qualify for the
outdoor exemption, such as by holding tool box talks outdoors instead
of in a traditional indoor location. This may result in more employees
falling within the exemption than estimated by OSHA; therefore, OSHA's
cost analysis likely overestimates costs.
The requirements of the ETS also do not apply to settings where any
employee provides healthcare services or healthcare support services
when subject to the requirements of 29 CFR 1910.502 (the Healthcare
ETS). The Healthcare ETS is a temporary standard that may not remain in
effect for the entire period that 29 CFR 1910.501 remains in effect.
This means that some employers or employees covered by the Healthcare
ETS, those in firms that have 100 or more employees, may ultimately be
covered by 29 CFR 1910.501 (because the exception in 29 CFR 1910.501 is
limited to when employers are subject to the requirements of the
Healthcare ETS). This potentially impacts two types of costs: Employer-
based costs (e.g., employer policy on vaccination) and employee-based
(periodic) costs (e.g., recordkeeping).
Employer-Based Costs: For the purpose of the economic analysis
only, OSHA treats the Healthcare ETS as though it will no longer be in
effect after December, 2021, because at that point the Healthcare ETS
will have been in effect for the six months that OSHA had calculated
costs for that ETS. Therefore, OSHA estimates that some employers
including those with 100 or more employees subject to the 29 CFR
1910.502 exemption, will need to take employer-based costs because all
these employers will ultimately be subject to 29 CFR 1910.501 under
this assumption.
Employee-Based Costs: OSHA's estimates incorporate two assumptions
for the purposes of this analysis only. First, for the purposes of
assumptions for this analysis only, Sec. 1910.501 will remain in
effect for 6 months. Second, many employers and employees currently
covered only by the Healthcare ETS will be subject to the requirements
of 29 CFR 1910.501 for approximately 4 months (4 months of the 6 month
estimated lifespan of 29 CFR 1910.501). OSHA's estimate of those
employees exempted by the Healthcare ETS was based on the Industry
Profile of employees in firms with 100 employees or more covered by the
Healthcare ETS, as estimated in Table VI.B.3 in the economic analysis
for that rulemaking (see 86 FR 32488).
OSHA notes that some employees currently covered by the Healthcare
ETS might also be currently covered by 29 CFR 1910.501 (albeit at
different times or in different locations) because the Healthcare ETS
is settings-based. For example, a pharmacist would normally not need to
comply with the requirements of Sec. 1910.502 when just filling
prescriptions in a retail pharmacy store (see 29 CFR
1910.502(a)(2)(ii)), but would need to comply when administering
vaccinations within an embedded clinic inside that retail pharmacy.
Thus, there are a number of variables that could impact the extent to
which the pharmacist's employer might
incur any costs. However, even to the extent that such costs might
occur (e.g., recordkeeping for testing if the pharmacist works for an
employer covered by 29 CFR 1910.501 and is unvaccinated), OSHA judges
that they would be de minimis for several reasons. First, this pool of
workers is likely to be very small, especially when compared to the
population of workers covered by the Healthcare ETS. Second, most
employees subject to both standards will have been fully vaccinated
before OSHA takes costs for these employees under 29 CFR 1910.501 by
operation of the CMS rule mandating vaccination or as a result of the
voluntary vaccination incentives promoted by OSHA's Healthcare ETS
(therefore negating most of the costs associated with vaccination and
testing under 29 CFR 1910.501). Third, any underestimate of periodic
costs will only apply during the first two months after 29 CFR 1910.501
goes into effect and the standard has a delayed compliance date of 30
days after the effective date for most provisions, except for testing,
which has a delayed compliance date of 60 days. This will further
lessen the periodic costs associated with any potential underestimate.
In all respects (other than the \4/6\ share of employee-based
costs), OSHA is taking the same approach in the Industry Profile and
Cost Estimates for employers and employees currently covered by the
Healthcare ETS as it does for all other industries. These employers and
employees are fully integrated into Table IV.B.5, below, which contains
a summary of covered entities and employees. Moreover, the same
assumptions on outdoor work and other scope exemptions that OSHA
explains earlier holds for these employers and employees. In addition,
OSHA makes the same downward adjustment in telework for these employers
and employees in accordance with the methodology it sets out below.
Thus, the Healthcare ETS profile used in this ETS to account for
employees exempted by the Healthcare ETS into the Profile in the event
the Healthcare ETS expires (i.e., in Table IV.B.5, below) is an updated
version of Table VI.B.3 in the Healthcare ETS (see 86 FR 32488).\23\
OSHA notes that some firms may decide to proactively comply with
certain 29 CFR 1910.501 requirements (such as mandating vaccination for
all employees that were removed from the Industry Profile) before the
end date of the Healthcare ETS based on the conclusion that 29 CFR
1910.501 will ultimately apply in full to them. Since these costs still
occur due to 29 CFR 1910.501, OSHA is appropriately including them in
this cost analysis.
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\23\ The CMS rule published elsewhere in this issue of the
Federal Register mandates vaccination for employees in facilities
that receive Medicare or Medicaid. OSHA is ignoring this for the
purpose of its cost analysis and taking costs into account as if the
CMS rule were not promulgated. This creates a substantial
overestimate.
---------------------------------------------------------------------------
There are 9.9 million employees who will newly be covered by 29 CFR
1910.501 starting in December whose employers will incur an additional
$318 million in costs. These costs are integrated into the agency's
main cost analysis, which is described later in this economic analysis.
Only some state- and local-government entities are included in this
analysis. State- and local-government entities are specifically
excluded from coverage under the OSH Act (29 U.S.C. 652(5)). Workers
employed by these entities only have OSH Act protections if they work
in states that have an OSHA-approved State Plan. (29 U.S.C. 667).
Consequently, this analysis excludes public entities in states that do
not have OSHA-approved State Plans. Table IV.B.2 presents the states
that have OSHA-approved State Plans and their public entities are
included in the analysis.
[GRAPHIC] [TIFF OMITTED] TR05NO21.001
OSHA notes, finally, that the percentage of employers mandating
vaccination, and hence the employee vaccination rate, would likely rise
to some degree absent this ETS due to other federal actions, such as
the vaccination mandate for federal contractors, the CMS rule published
elsewhere in this issue of the Federal Register, and as a result of
vaccination mandates that have been adopted at state and local levels.
This analysis does not account for increases in vaccination that would
occur absent the standard, resulting in a likely overestimate of the
costs.
c. Teleworking
Dingel-Neiman Approach for Estimating Who Can Work Remotely
OSHA uses the estimates in a paper by J.I. Dingel and B. Neiman,
``How Many Jobs Can be Done at Home?,'' published in July 2020, as a
starting point to determine the percentage of employees, by occupation,
who are not expected to work remotely (i.e., the percentage of workers
for whom employers have employee-based costs under this ETS) (Dingel
and Neiman, July 2020).
In Dingel and Neiman's paper, the authors estimate the number of
jobs in the U.S. economy that workers can feasibly perform remotely.
The authors use two different surveys from the
Occupational Information Network (O*Net) \24\ to evaluate which
occupations can be performed remotely and combine the O*Net estimates
with the Bureau of Labor Statistics' (BLS) Occupational Employment and
Wage Statistics (OEWS) data on employment by occupation to estimate the
total number of workers nationally who can work remotely.
---------------------------------------------------------------------------
\24\ 24 The O*Net Program is a major source of occupational
information for the U.S. The O*NET database surveys ask both
specific occupational experts and workers in those occupations
questions covering multiple aspects of almost 1,000 occupations
covering the entire U.S. economy. See https://www.onetonline.org/
for more information. The occupation definitions in the O*NET data
are Standard Occupation Codes--the same definitions that are used in
the BLS OEWS data. Dingel and Neiman use the responses to two
surveys included in release 24.2 of the database administered by
O*NET, the Worker Context Questionnaire and the Generalized Work
Activities Questionnaire. The occupation with the median number of
respondents had 26 respondents for each work context question and 25
respondents for each generalized work activities question per
detailed-level SOC occupation code.
In the O*Net Questionnaires, survey respondents responded to
statements about the nature and requirements of the daily tasks
associated with their job on a 1-5 ordinal scale, where 5 represents
the strongest agreement and 1 represents the strongest disagreement
(see Table IV.B.3). The O*Net data contain the average response to
each question for each occupation code. For instance, for occupation
``Chief Executives'' (SOC 11-1011), the average response to the
prompt ``Performing General Physical Activities is very important''
was 1.39, indicating that performing general physical activity is
not, on average, critical to the work of chief executives. The
average responses by occupation for other prompts in the relevant
surveys utilized by Dingel and Neiman are contained in those
surveys.
---------------------------------------------------------------------------
To evaluate the survey responses, Dingel and Neiman first
determined the occupations for which the average response to a given
prompt met a preset threshold. Table IV.B.3 presents the Dingel and
Neiman response threshold for each survey question as well as the
percent of occupations that meet each respective predetermined
threshold. For example, in 10.8 percent of occupations, the average
response to the ``Performing general physical activities'' (4.A.3.a.1)
question met the threshold, falling in the range of 4 to 5.
Dingel and Neiman determined that employees in a given occupation
can telework full time if they did not meet the predetermined threshold
for any of the questions highlighted in grey and denoted with a ``Yes''
in the column that reports whether that activity is used in determining
whether a job can be done remotely in Table IV.B.3.
[GRAPHIC] [TIFF OMITTED] TR05NO21.002
Source: (Dingel and Neiman, July 2020).
Adjusting Dingel and Neiman To Reflect Current Conditions
While many employees can and are working remotely, many have
returned to their places of employment. This conclusion is borne out by
BLS's Current Population Survey (CPS) (BLS, 2021c). To address the
tendency toward employees returning to work on site and more accurately
reflect current remote work conditions, OSHA made two adjustments to
Dingel and Neiman's estimates. In the COVID-19 Healthcare ETS, OSHA
also used Dingel and Neiman's paper to estimate the number of workers
who teleworked in response to the pandemic and the ETS under the
assumption that anyone who could work remotely would do so in response
to the pandemic and the Healthcare ETS. Dingel and Neiman's estimates
are therefore framed as the upper-bound of potential teleworking.
The adjustments OSHA made reflect changing circumstances. First,
based on agency expertise, OSHA changed the status of certain
occupations in its occupational list from working remotely to not
working remotely. For example, when Dingel and Neiman published their
study, many schools were operating virtually so the Dingel and Neiman
finding that teachers were able to work remotely lined up with the
situation where teachers were working remotely. At this point in the
pandemic, on the other hand, in-person learning has mostly recommenced.
To this end, OSHA changed the status of teachers and other employees in
the education sector from working remotely to not working remotely in
this analysis. As another example, many activities that ceased or were
reduced significantly have now resumed and many locations that were
closed to the public have reopened (e.g., athletic events, shows, gyms,
casinos and places of worship), and, since more people have returned to
the office, there is more need for childcare. Therefore, OSHA also
changed the status of these employees and others from telework to non-
telework. This has the ultimate effect of increasing costs estimates
for the rule.
Appendix A (Table A-1), in the accompanying document in the docket,
``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
Appendices'' (OSHA, October 2021b), presents Dingel and Neiman's (July
2020) unmodified percentages of workers that can work remotely in each
detailed occupation (based on BLS's Standard Occupation Code
(SOC)).\25\ Appendix A also presents, in separate columns, percentages
reflecting the modifications OSHA made in those occupations where OSHA
changed the results from telework to non-telework for the reasons
stated, as well as percentages reflecting the modifications made in
occupations where employees work exclusively outdoors.
---------------------------------------------------------------------------
\25\ Except for the adjustments to Dingel and Neiman discussed
above, OSHA used the Dingel and Neiman estimates for telework by
occupation without change. The agency recognizes that the authors'
methodology (i.e., the use of 0-1 thresholds) led to a small number
of results that may appear not to reflect real-world experiences
within an occupation. However, Dingel and Neiman represents the best
available evidence for determining the percentage of employees, by
occupation, who are expected to work remotely. OSHA is aware of no
other source for this information that contains the level of detail
necessary to conduct this analysis. Moreover, as explained above,
OSHA modified the results for individual occupations when it had a
reasoned basis for doing so. In any event, every NAICS industry is
comprised of many occupations, so for every occupation where OSHA
suspects remote work is overestimated in Dingel and Neiman's
results, there may be another where remote work is underestimated.
---------------------------------------------------------------------------
According to the OSHA-adjusted Dingel and Neiman estimates, 14
percent of the jobs in the United States are performed entirely at
home, with significant variation across cities and industries. It
should be noted that the Dingel and Neiman analysis does not specify a
proportion of jobs that can be performed at home part of the time;
under the analysis, employees are either working remotely full-time or
are working on site full time.
The second adjustment OSHA made used monthly COVID-specific
teleworking data from telework questions added during the pandemic to
the CPS to estimate the reduction in teleworking since its peak and
applied those estimates to further adjust downward the number of
workers currently teleworking (BLS, 2021c). Specifically, the CPS
questions asked respondents whether they were teleworking due to COVID-
19 (as opposed to teleworking for other reasons) and OSHA estimated the
difference in teleworking from the peak of COVID-related teleworking in
all industries, which occurred in May 2020, through August 2021 (see
Table IV.B.4).\26\ The reduction in teleworking was then applied as the
change in percentage points to the estimated overall level of employees
covered by the ETS in each NAICS code estimated based on data from
Dingel and Neiman (July 2020). OSHA's final teleworking estimates are
provided in Appendix B in the accompanying document in the docket,
``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
Appendices'' (OSHA, October 2021b). Reductions due to employees working
exclusively outdoors were applied to reduce the percentage of covered
employees in Appendix B as well.
---------------------------------------------------------------------------
\26\ The CPS data were available only at the 2-digit NAICS level
as shown in Table IV.B.4.
---------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TR05NO21.003
Other Teleworking Literature
A number of companies have announced plans to allow employees to
work from home at least through the end of 2021--suggesting that the
levels of remote work will not be returning to pre pandemic levels in
the near future. Many technology and internet based companies, such as
Dropbox, Coinbase, VMWare, and Slack, have announced a complete,
permanent move to fully remote work (Courtney, September 27, 2021).
Large employers such as Facebook, Amazon, and Siemens plan to maintain
some physical workspace but now offer their employees who are telework
eligible the option to work from home at least part of the time on a
permanent basis (Id.). Google, Ford, Amazon, Apple and other large
employers are expecting their telework eligible workers to return to
on-site work (in some capacity) no earlier than January 2022 with Lyft
anticipating a February 2022 return (Cerullo, August 31, 2021). As a
final example, a survey of businesses in Massachusetts found that about
40 percent of teleworkers anticipate they will not be returning to the
office in January 2022 or earlier (Chesto, June 22, 2021).
Additional studies provide qualitative support for the conclusion
that a range of employees will ``predictably'' work from home both
during the pandemic and beyond. In Bick, Blandin, and Martens's paper,
``Work from Home Before and After the COVID-19 Outbreak'' the authors
use the following information to establish the physical location of
employment (home or workplace) of workers: Data from the Real-Time
Population Survey (RPS), a
national labor market survey of adults between ages 18-64 that mirrors
the Current Population Survey (CPS) and collects information used in
pandemic analysis, such as commuting behavior before and after the
World Health Organization declared a global pandemic; mobility data on
commuting; and information from the CPS since May 2020 on `pandemic-
related' telework (Bick et al., February 2021).
Based on these data, Bick et al., found that there was a sudden
decline in commuting trips in the U.S. after the initial COVID-19
outbreak, and that even when these trips subsequently began increasing
back toward the original number of commuting trips, the overall number
of trips did not return to normal at the end of 2020 because many
teleworking employees continued working from home. The authors found
that the surge in work from home came almost entirely from employees
working from home every workday in the reference week. The authors also
suggest that, for some occupations, especially those occupations with
more educated workers, the change to increased work from home appears
to be a long-term change; the data showed that, as of December 2020,
12.5 percent of these workers reported they expect to be working from
home full-time in the future, and 24.5 percent reported they expect to
be working from home part-time.
In ``COVID-19 and Remote Work: An Early Look At U.S. Data,''
Brynjolfsson et al., noted that some of the shift to working from home
seems to be a long-term phenomenon (Brynjolfsson et al., June 2020).
The authors found, using an online survey, that 35.2 percent of workers
had switched to working from home. Additionally, 15 percent of workers
reported they were already working from home before COVID-19.
Therefore, this study finds that about half of workers are now working
from home--an even greater percentage than estimated by Dingel and
Neiman.
Finally, in ``Why Working from Home Will Stick,'' Barrero et al.
predict that 22 percent of all full workdays will be performed from
home after the pandemic ends, compared to 5 percent before (Barrero et
al., April 2021). The authors highlight five factors contributing
towards the more permanent shift to telework: Diminished stigma,
better-than-expected experiences working from home, investments in
physical and human capital enabling work from home, reluctance to
return to pre-pandemic activities, and innovation supporting work from
home.
d. Affected Entities and Employees
OSHA used data from the U.S. Census' 2017 Statistics of U.S.
Businesses (SUSB) to identify private sector entities and employees
affected by this section of the ETS (U.S. Census Bureau, 2019), and
used the BLS 2017 Quarterly Census of Employment and Wages (QCEW) to
characterize state and local government entities (BLS, 2017). SUSB
provides estimates of entities and employees by employer size range,
which OSHA used to exclude employers with fewer than 100 employees.\27\
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\27\ SUSB with revenue data is only collected every 5 years.
While OSHA could attempt to extrapolate these data to more recent
years, the results would be imprecise because they would change the
revenue-employee size distributions. Those distributions are crucial
for measuring impacts so the agency has opted to use the data as is.
The total number of employees in OSHA's estimate is fairly close to
that of SUSB. The 2017 SUSB data includes a total of 128.6 million
employees, while the more recent 2018 SUSB data includes a total of
130.9 million.
---------------------------------------------------------------------------
For rail transportation (NAICS 482), which is not included in SUSB
or QCEW data, OSHA relied on Federal Railroad Administration and
Association of American Railroads statistics reported in OSHA's 2020
final rule, Cranes and Derricks in Construction: Railroad Roadway Work.
See 85 FR 57109 (September 15, 2020). OSHA used these data sources to
identify public and private railroad employers with more than 100
employees. For agricultural NAICS (111 and 112), OSHA relies on the
National Agricultural Statistics Service, 2017 Census of Agriculture
(NASS, 2017) to obtain estimates of total entities, employees, and
revenues. Since these data do not indicate the number of entities with
more than 100 employees, OSHA assumes it is the same as the average
proportion as the support activity sectors for crop and animal
production (NAICS 114 and 115). OSHA similarly specifies teleworking
conditions for NAICS 111 and 112 using the average result for support
activities for agriculture (NAICS 114 and 115). For the postal service
industry, NAICS 491110, which is not included in SUSB, OSHA obtains
total entity and employment data for private postal services from the
QCEW. Since these data do not indicate the number of entities with more
than 100 employees, OSHA assumes it is the same as the average
proportion as the related industries, couriers and express delivery
(NAICS 492110), and local delivery (NAICS 492120).
OSHA used the BLS 2020 Occupational Employment and Wage Statistics
(OEWS), which provides NAICS-specific estimates of employment and wages
by occupation, along with the data in Appendix B (discussed earlier),
to determine the subset of non-teleworking employees affected by the
ETS.
Table IV.B.5 summarizes the set of entities covered by the ETS.
OSHA estimates a total of approximately 263,879 entities and
approximately 1.9 million establishments incur costs under the ETS.\28\
OSHA estimates these entities employ approximately 102.7 million
employees, and of these, OSHA estimates approximately 84.2 million
employees are covered by the ETS and are not excluded from coverage by
working remotely 100 percent of the time or exclusively outside.\29\
For the purpose of this analysis, OSHA estimates that all employees
that OSHA estimated will work remotely will continue to do so for the
duration of this ETS.\30\
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\28\ This includes public entities only in states with an
approved OSHA State Plan. See Table IV.B.2 above for further
discussion of state plans.
\29\ OSHA's estimate of covered employees is based on the
discussion in the text. For example, as OSHA writes above: OSHA
assumes for the purpose of its analysis that employers covered under
the Contractor Guidance will conduct work at least some of the time
in workplaces not covered under that Guidance and so are fully
integrated into the scope of the ETS; and the employers and
employees covered by the Healthcare ETS are also fully integrated
into the scope of the ETS.
\30\ Conditions are changing rapidly, and though many firms are
planning to keep expanded telework to some extent, as the rate of
vaccinated workers increases, there may be increased movement back
to the workplace beyond what OSHA has estimated here.
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[GRAPHIC] [TIFF OMITTED] TR05NO21.005
[GRAPHIC] [TIFF OMITTED] TR05NO21.006
III. Baseline Vaccine Status for Covered Employees
To estimate the cost of the ETS, OSHA must first estimate the
baseline vaccination status for the 84.2m covered employees (those who
work for employers with 100 or more employees and are not otherwise
excluded from coverage). OSHA recognizes that employees' current
vaccination status continues to change on a daily basis. When
specifying baseline vaccination rates, OSHA used the most recently
available vaccination data from CDC, reflecting current conditions. For
the remaining set of unvaccinated employees covered by the ETS, after
accounting for baseline vaccinations, OSHA estimates the number of
these employees who will be vaccinated and the number who will test
under the ETS. OSHA's methodology for this analysis is detailed below.
a. Estimate the Current Vaccination Rate for Covered Employees
To estimate the current vaccinate rate for covered employees, OSHA
obtained recent vaccination data by age group from the CDC COVID Data
Tracker (CDC, October 4, 2021a).\31\ For age groups covering 18-74
years old, these data include the number of people who are fully-
vaccinated as well as the number of people of who have initiated their
first shot in the past two weeks (relative to the October 4, 2021
data).\32\ OSHA estimates the vaccination rate for each group (percent
of total population in the age group who are vaccinated) based on the
total number of people who are fully-vaccinated and had their first
shot in the past two weeks, as a fraction of the population in each age
group, obtained from the BLS Current Population Survey (CPS) (BLS,
2021d). Then, to estimate the overall average vaccination rate across
age groups 18-74 years old, OSHA weighted each group based on the
distribution of the labor force by age, also obtained from the BLS CPS
(BLS, 2021d). As shown in Table IV.B.6, OSHA estimates an overall
vaccination rate of 61.3 percent for covered employees (and 38.7
percent unvaccinated). The healthcare sector had an earlier push to get
healthcare workers vaccinated and has a higher current rate, estimated
to be 70 percent.\33\
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\31\ The data from the CDC website was retrieved on October 4,
2021.
\32\ Age groups included: 18-24, 25-39, 40-49, 50-64, and 65-74.
OSHA had not included the group 65-74 in the economic analysis of
the Healthcare ETS this past spring because for the healthcare
sector, using the population wide average of workers in this age
bracket was felt would overcount the number of such workers in this
sector. OSHA is including this group now that more of the other age
populations have been vaccinated and those concerns are no longer as
relevant. This ETS will therefore indicate that a slightly higher
percentage of universe of covered employees is vaccinated than if
that age group of 65-74 was excluded altogether, but it also
increases the number of employees for which additional compliance
costs are factored in. OSHA interprets the ultimate result as a more
accurate reflection of the workplace and notes that more costs are
included than if the age group had been excluded from the analysis.
\33\ The agency takes a recent survey (Lazer et al., August 16,
2021) which breaks out rates for healthcare vaccination and non-
healthcare, and rather than replacing the CDC base vaccination rate
uses the CDC rate to make an adjustment upwards to the healthcare
rate of 70 percent.
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[GRAPHIC] [TIFF OMITTED] TR05NO21.007
Based on the above, OSHA estimates that the 84.2m covered employees
includes 52.5 million (62 percent) vaccinated employees and 31.7
million unvaccinated employees (38 percent).
b. Adjust Baseline Vaccination for Continuing Trends
OSHA adjusts the current vaccination rate to account for continuing
trends in vaccinations among covered employees due to employers'
continued implementation of vaccine mandates and other policies
(described below), under the ETS. To make this adjustment, OSHA
requires 1) further characterization of the set of unvaccinated
employees in terms of their likelihood to receive the vaccine, and 2)
specification of the extent of employer-mandated and other employer
vaccination policies.
Based on vaccine confidence data from CDC (CDC, October 2021a),
13.8 percent of the population ``probably or definitely will not'' get
the vaccine; hereafter referred to as ``vaccine-hesitant''. Since this
group is by definition part of the currently unvaccinated, OSHA
characterizes the currently unvaccinated (37.6 percent) as being
comprised of those who are vaccine--hesitant (13.8 percent) and the
remainder, who while unvaccinated, are not hesitant because they are
not in the ``probably or definitely will not'' group (23.8 percent).
Among those who are vaccine-hesitant, OSHA estimates that 5 percent
of covered employees (or about 36 percent of the vaccine-hesitant), are
hesitant due to a religious (4 percent) or medical (1 percent)
exemption. The remaining 8.8 percent include those who are vaccine-
hesitant for other reasons. For the 4 percent estimate for religious
exemptions, OSHA relies on data from Vermont, which removed its vaccine
exemption for nonreligious personal beliefs in 2016 and saw the
proportion of kindergarten students with a religious exemption rise to
about 4 percent (Graham, September 15, 2021). In analyzing this issue,
the agency also reviewed other religious exemption data concerning
state workers in Oregon and Washington; the agency decided not to rely
on these data because the Vermont data is a more accurate measure of
the correct religious exemption rate, although the data does represent
parents deciding on whether to claim an exemption for their child, not
for themselves. This is because, unlike the Vermont data, the Oregon
and Washington data contain workers that have applied, but not yet been
accepted, for a religious exemption (O'Sullivan, September 18, 2021;
KEZI News, September 25, 2021). In Oregon, 5 percent and in Washington
8 percent of the employees have requested accommodations though only a
fraction so far have been accepted. However, the data are not
inconsistent with the Vermont data even though the process in both
Oregon and Washington are not yet complete. For the 1 percent estimate
for medical exemptions, OSHA relied on the Household Pulse Survey (HPS)
conducted by the U.S. Census (U.S. Census Bureau, 2021). In Table 6a of
the Health Tables for Week 31, September 1, 2021 through September 13,
2021, about 1% of the US population said they would not get the vaccine
because ``Doctor has not recommended it,'' and OSHA uses this response
as a proxy for all medical conditions.\34\
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\34\ Table 6a presents that 3,884,902 of the population will not
take the vaccine because the ``doctor has not recommended it'' out
of a total of 38,936,606 who will not get the vaccine for any
reason. Medical reasons are then about 10% of the general population
that will not get the vaccine, and the ones who won't get the
vaccine are about 10% of the whole population, giving 1% (.10 *
.10).
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Table IV.B.7 presents the number of employees in each vaccination
category, which informs OSHA's subsequent estimates of which currently
unvaccinated employees may be vaccinated by employer-mandates,
vaccinated under the ETS, or tested under the ETS.
[GRAPHIC] [TIFF OMITTED] TR05NO21.008
Next, OSHA estimates the number of currently unvaccinated employees
that are likely to become vaccinated while the ETS is in effect, based
on their employers' policies. Based on limited data on current vaccine
mandate implementation and forecasts for future implementation (Mishra
and Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons,
October 6, 2021), OSHA estimates that 25 percent of firms in scope
currently have a mandate, and assumes that this will rise to 60 percent
of employers after the ETS is in place. The baseline of 25 percent is
based on recent surveys showing a range of approximately 13-45 percent
of employers currently requiring or planning to require vaccination
among employees (see Willis Towers Watson, June 23, 2021; Mishra and
Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
2021). Absent the ETS, OSHA assumes that the percentage of firms would
remain 25 percent (with some measure of upward adjustment due to other
federal vaccine mandates affecting select populations, as discussed
above). To the extent more firms than OSHA estimates would mandate
vaccination independent of the ETS and thereby increase the vaccination
rate (again because of factors such as other federal vaccine mandates),
then the agency's costs are overestimated because the agency's baseline
vaccination rate is too low. The assumption of an increase from 25 to
60 percent is based on the same set of surveys that indicate that the
share of employers who will mandate vaccinations after the ETS
(including those that already mandate vaccinations) range from 25-75
percent, see above references. The agency also assumes that employees
are distributed in the same proportion across employers with and
without a vaccine mandate (e.g., if 60 percent of firms mandate
vaccination, 60 percent of employees will be vaccinated due to the
mandate (less those who remain unvaccinated due to religious or medical
exemptions).
OSHA assumes that all unvaccinated employees subject to an employer
mandate will be vaccinated under that employer mandate, except for
those seeking a medical or religious exemption. For unvaccinated
employees not subject to an employer mandate, OSHA assumes that they
will also be vaccinated at their employer's request, except for
employees who are vaccine-hesitant, which includes not only those who
remain unvaccinated for medical and religious reasons, but also those
who are hesitant for any other reason. OSHA carries through its
assumptions and estimates into its total cost estimates. For example,
OSHA estimates that the 25 percent of firms in scope that currently
have a vaccination mandate will not need to implement a new written
policy on vaccination in response to the ETS since they will already
have implemented a policy that meets the requirements of the ETS.
In total, OSHA estimates that 27 percent of covered employees (22.7
million) will be vaccinated based on employer policies under the ETS;
or 72 percent of covered employees who are currently unvaccinated. The
resulting vaccination rate, adjusted for the ETS, is estimated based on
the total of those who are currently vaccinated and those who will be
vaccinated under employer policies, 89.4 percent as shown in Table
IV.B.8. Calculations of this nature, while not discussed in more detail
in this analysis, are contained fully in the spreadsheets supporting
this analysis (OSHA, October 2021a).\35\
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\35\ OSHA notes that these estimates differ for employees
covered by the Healthcare ETS. OSHA calculated these estimates
separately because, as stated above, OSHA is only taking costs for
these employees in the last four months of the assumed 6-month
period while the ETS remains in effect. While OSHA does not describe
in detail how it derived estimates for employees covered by the
Healthcare ETS in this analysis, the derivation of those estimates
run parallel to those described above. For more information, please
see the spreadsheets supporting this analysis. (OSHA, October
2021a).
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[GRAPHIC] [TIFF OMITTED] TR05NO21.009
From Table IV.B.8, OSHA estimates that approximately 75.3 million
(89.4 percent) of covered employees will be vaccinated when the ETS is
in full effect, and that approximately 8.9 million employees (10.6
percent, made up of approximately 6.3 million covered employees who
will be tested for COVID under the ETS and approximately 2.6 million
employees who return to telework (see next paragraph)) will remain
unvaccinated. This final set of unvaccinated employees includes all
employees not vaccinated because of religious or medical accommodations
or medical contraindication, plus the portion of those who are vaccine-
hesitant for any other reason, who were not vaccinated because their
employer has opted for a voluntary vaccination policy.
From the above, OSHA estimates that about 5 percent of all covered
employees will seek and receive religious or medical accommodations or
exemption for medical contraindication. While the agency encourages
employers to consider the most protective accommodations such as
telework, which would prevent the employee from being exposed at work
or from transmitting the virus at work, for cost analysis purposes the
agency assumes these workers will largely be tested in order for their
employers to comply with the ETS. Consistent with the overall average
22 percent of those who returned to work after teleworking earlier in
the pandemic (see teleworking discussion above), OSHA assumes for this
cost analysis that only 22 percent of workers needing a reasonable
accommodation will return to full time telework as a reasonable
accommodation. OSHA also assumes that the 78 percent remainder will
follow the testing/masking protocols in the ETS as a reasonable
accommodation.
For hesitant employees who will not seek a religious or medical
accommodation, and who work in a firm with a testing option, the agency
assumes as above that those who were teleworking before (again on
average 22 percent) will return to telework rather than being tested.
c. Cost of Absenteeism to Employers
Even mild cases of Covid-19 can be costly to employers as they can
induce productivity losses due to work absences, both among those
infected and their close contacts who may be subject to quarantine
requirements. While many workers were able to engage in telework in
March-April 2020, several occupational groups deemed essential,
including childcare workers, personal care aids, healthcare support
occupations, and food processing workers, exhibited significantly
higher rates of absenteeism during that period, which the authors
attributed to some workers contracting COVID-19 (Groenewold et al.,
July 10, 2020). Absenteeism can also affect the productivity of workers
who are present, similar to how turnover can impose costs on incumbent
workers (Kuhn and Yu, April 2021).
In aggregate, productivity losses from absences can be costly, as
evidenced by the economic losses from seasonal influenza. One estimate
found that the United States loses 20.1 million days of economic
productivity every year due to influenza, an ongoing loss equivalent to
80,400 full-time worker-years (Putri et al., June 22, 2018). Another
recent study found that higher influenza vaccination rates result in
both fewer deaths and significantly reduced illness-related work
absences (White, 2021).
OSHA recognizes that absenteeism has been a problem. However, as
explained in other sections of the preamble, the ETS vaccination and
testing and face covering requirements are necessary to reduce the
spread of COVID-19 in the workplace, which may in part reduce
absenteeism. The ETS might in a limited sense also increase absenteeism
because the rule requires employers to temporarily remove from the
workplace any employee who receives a positive COVID-19 test or is
diagnosed with COVID-19 by a licensed healthcare provider. However,
this provision will also help to further reduce absenteeism because,
when an
infected employee is promptly removed from the workplace, that can
prevent one employee from infecting other employees in the workplace
and potentially causing an outbreak or a super-spreader event. Thus,
OSHA concludes that the ETS may, on net, help ameliorate absenteeism by
reducing illnesses, but in any event will not increase absenteeism (see
OSHA, October 2021c).
d. The Effect of Employee Turnover
One of the primary concerns among employers in imposing vaccination
mandates is loss of staff, with 60 percent of employers selecting it as
a concern with regard to mandating COVID-19 vaccination, according to
one survey (Mishra and Hartstein, August 23, 2021).\36\ To this end,
employer vaccination mandates could lead to employee turnover;
employees could either leave on their own volition or employers who
have instituted strict vaccination policies may fire workers who are
not vaccinated, or place them on unpaid leave.
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\36\ This survey done in August, 2021, has 1,630 responses,
reported by HR staff, attorneys, and executives. Described as being
``from a variety of industries,'' 83 percent of respondents were
from companies with more than 100 employees.
---------------------------------------------------------------------------
On the other hand, there is countervailing evidence to suggest that
employers who implement a vaccine mandate will be met with an influx of
potential workers. Many employees would prefer a mandate in place, and
would be more likely to stay with, or apply to, a firm that had a
vaccine mandate in place. For example, although Inova health system in
Northern Virginia, lost 89 workers for noncompliance with the system's
vaccination mandate, that loss amounted to less than 0.5 percent of its
workforce, (Portnoy, October 3, 2021), and, in any event, Inova's CEO
stated that the vaccine mandate has helped with recruitment, and that
its workers are concerned for their own safety and want to know they
are working with vaccinated colleagues. This same article listed some
other Virginia healthcare systems with higher rates of loss in
connection with vaccine mandates. Valley Health terminated 1 percent of
its employees, while Luminis Health had about 2 percent of its workers
still unvaccinated at the time of its mandate deadline. As another
example, although United Airlines had 593 employees (out of the
company's 67,000 U.S. employees) who had not complied with the
company's vaccination mandate at the end of September (a number that
dropped below 240 employees by October 1), the company reported it has
received 20,000 applications for 2,000 flight attendant positions, a
much higher ratio than before the pandemic (Chokshi and Scheiber,
October 2, 2021). In addition, one survey reports that among employee
resignations due to COVID-19 workplace policies, 42 percent reported
lack of workplace safety policies, 17 percent reported that existing
workplace policies were not stringent enough, and only 39 percent
reported overly restrictive workplace policies, suggesting that many
employees will welcome vaccine mandates (ASU COVID-19 Diagnostic
Commons, October 6, 2021).\37\
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\37\ This August 2021 global survey (all results presented here
are for the US only) has 1,143 responses. It covers 28 industries,
including: Technology and Software, Business and Professional
Services, Manufacturing, Construction, and Healthcare. Ninety
percent of respondents were from companies with more than 100
employees.
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While employee turnover is a natural part of business in any
industry, higher employee turnover rate than normal can have a direct
impact on profit and revenue. The normal range of employee turnover
differs widely by industry, with an average turnover rate of about 50
percent per year overall for the private sector.\38\ For example,
between 2016 and 2020, employee turnover ranged from 55 percent to 70
percent in the retail industry and from 40 percent to 60 percent in the
transportation industry (the industry sectors with the highest
employment).\39\
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\38\ BLS (March 11, 2021).
\39\ Id.
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OSHA acknowledges that a vaccine mandate may result in increased
employee turnover, but one recent survey \40\ suggests it is very
unlikely that this potential increase in employee turnover will exceed
the ranges that industries have experienced over time. The survey,
though limited because many respondents did not have mandates in place
at that time, shows that there was no impact on turnover for 71 percent
of those with mandates in place. Only 25 percent saw a slight increase
in turnover (1 percent to 5 percent above normal) and only 4 percent
saw a significant increase (more than 5 percent above normal). As such,
OSHA does not anticipate that the potentially increased employee
turnover attributable to vaccine mandates will be substantial enough to
negate normal profit and revenue.
---------------------------------------------------------------------------
\40\ Umland, October 13, 2021. This October 2021 survey has
1,059 total respondents, though only 365 have implemented a
vaccination mandate and answered this turnover question.
---------------------------------------------------------------------------
To this end, an important factor to consider in examining turnover
in connection with vaccine mandates is the unquantified cost savings
and other positive economic impacts accruing to employers that
institute vaccine mandates. These include reduced absenteeism due to
fewer COVID-19 illnesses and quarantines, as discussed above. Other
positive economic impacts of a vaccine mandate are increased retail
trade from customers that feel less at risk and better relations with
suppliers and other business partners. These all would contribute to
improved business and increased profits.
The existence of these cost savings and other positive economic
impacts accruing to employers that comply with the ETS suggests that
the actual net costs of the ETS could be much lower than the costs
reported in this section of the economic analysis. As OSHA discusses
above, OSHA has provided evidence to support its estimate that 25
percent of covered employers already voluntarily require that their
employees be vaccinated and a much larger percentage are considering a
vaccine mandate. This supports the conclusion that these businesses
agree that doing so will ultimately save costs.
In addition, under the ETS, employers may implement a policy that
allows for testing and face covering instead. Firms will have a
tendency to self-select: If a large proportion of its work force has
indicated concern about a vaccine mandate, the firm is more likely to
choose the testing option to retain their workers. This is one factor
that led the agency to estimate that approximately 40 percent of
employers will allow employees to choose testing and face coverings in
lieu of vaccination. To the extent employers are concerned about
employee testing costs, employers can generally absorb testing costs or
help employees reduce those costs through low-cost assistance such as
employer proctoring of tests (even though that is not required by this
ETS). Departure of personnel because of vaccine mandates is also likely
to be less common when vaccine mandates are more prevalent across
employers in a region or industry. One survey reports that 65 percent
of employers state that actions of other companies in their industry
are very, or at least moderately, important in deciding to mandate
vaccination (Mishra and Hartstein, August 23, 2021).
Mandatory vaccinations for COVID-19 are still relatively new
because vaccines only became available in quantities sufficient to
support such mandates only about 6 months ago, and the FDA has only
recently moved past emergency clearance to final clearance. While there
is not an abundance of evidence about whether employees have actually
left or joined an employer based on a vaccine mandate,
particularly one with an alternative allowing for testing in lieu of
vaccination, OSHA has examined the best available evidence it could
locate in the timeline necessary to respond with urgency to the grave
danger addressed in this ETS. Based on that, OSHA is persuaded that the
net effect of the OSHA ETS on employee turnover will be relatively
small, given the option for employers to implement a testing and face
covering policy and the countervailing forces surrounding turnover that
will limit those effects, as discussed above.
Finally, OSHA finds one line of evidence particularly persuasive
because it involves data instead of polls: While different surveys may
suggest different levels of worker intentions (joining or remaining
with a safer employer versus leaving an employer to avoid
vaccination),\41\ the data suggests that the number of employees who
actually leave an employer is much lower than the number who claimed
they might: 1% to 3% or less actually leave, compared to the 48-50% who
claimed they would.\42\ As discussed earlier, this turnover number is
well below the average turnover rate in most industries. Thus, OSHA
concludes that whether or not the ETS proves helpful to recruitment
efforts for some employers, it will not, on balance, add significant
new costs to covered employers or threaten the economic feasibility of
any industry during a six month period.
---------------------------------------------------------------------------
\41\ Two polls from June 2021, when the number of COVID-19 cases
had dropped dramatically just before the Delta Variant led to a
surge in cases, indicated that 50% of unvaccinated employees
surveyed said that they would leave their job rather than accept a
vaccination mandate from their employer. (KFF et al., June 30, 2021)
(the same percentage also responded that ``The number of cases is so
low that there is no need for more people to get the vaccine.''). A
separate poll from the same time also stated that 48% of ``vaccine
hesitant'' employees claimed they would quit their jobs rather than
be vaccinated. (Barry et al., September 24, 2021--citing yet
unpublished June 2021 poll). In a more recent poll, about 44% of
workers said that they would consider leaving their jobs if they
were forced to get vaccinated, while around 38% of workers would
consider leaving their current employer if the organization did not
enact a vaccine mandate. (Kelly August 12, 2021). Interestingly, in
that survey there was a direct correlation between the age of the
worker and the desire to have a vaccinated workplace: Younger
workers, usually the most mobile portion of the workforce, had a
much higher desire for a vaccinated workforce (50% of Generation Z
employees, as compared to 33% of Baby Boomers).
\42\ An article titled ``Unvaccinated Workers Say They'd Rather
Quit Than Get a Shot, but Data Suggest Otherwise'' noted the 48%-50%
threat to leave, but included hard data showing nothing close to
those levels actually occurred: Houston Methodist Hospital required
its 25,000 workers (including its 3,580 unvaccinated employees) to
get a vaccine by June 7, and only 153 resigned or were fired (4% of
the 3,580 unvaccinated employees; 0.6% of the total number of
employees); other examples of the numbers of employees who left in
response to their employers' mandatory vaccine policy involved 5 out
of 527 (0.9%), 2 out of 250 (0.8%), 6 out of 260 (3%), and 125 out
of 35,800 (0.3%). (Barry et al., September 24, 2021).
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OSHA seeks comments on these estimates and conclusions, as well as
further data that it could use to refine its estimates.
IV. Cost Analysis for COVID-19 Vaccination and Testing ETS, Sec.
1910.501
In this section, OSHA provides estimates of the per-entity and
total costs for the requirements of this ETS. Section 6(c)(3) of the
OSH Act states that the Secretary will publish a final standard ``no
later than six months after publication of the emergency standard.''
Costs are therefore estimated over a six-month time period. Note that
the estimates are presented in this section at the 3-digit NAICS level,
but the analysis was conducted at the 6-digit NAICS level and
aggregated to the 3-digit level for presentation purposes. The 6-digit
NAICS level data is accessible in the supporting spreadsheet. It should
be noted that this analysis deals strictly with averages. For any given
entity, actual costs may be higher or lower than the point estimate
shown here, but using an average allows OSHA to evaluate feasibility by
industry as required by the OSH Act. In addition, OSHA has limited data
on many of the parameters needed in this analysis and has estimated
them based on the available data, estimates for similar requirements
for other OSHA standards, consultation with experts in other government
agencies, and internal agency judgment where necessary. OSHA's
estimates are therefore based on the best evidence available to the
agency at the time this analysis of costs and feasibility was
performed.
As mentioned above, OSHA estimates that approximately 264,000
entities have employees who will be subject to the requirements of the
ETS, including approximately 84.2 million employees. Many ETS
requirements result in labor burdens that are monetized using the labor
rates described next.
a. Wage Rates
OSHA used occupation-specific wage rates from BLS 2020 OEWS data
(BLS, 2021a). Within each affected 6-digit NAICS industry, OSHA
calculated the employee-weighted average wage to be used in the
analysis. OSHA estimated loaded wages using the BLS' Employer Cost for
Employee Compensation data (BLS, 2021b), as well as OSHA's standard
estimate for overhead of 17 percent times the base wage.
Costs are estimated using three labor rates for each NAICS
industry: The average labor rate for all employees, the labor rate for
General and Operations Managers (SOC code 11-1021), and the labor rate
for Office Clerks, General (SOC 43-9060). Industry-specific wage rates
are presented in Appendix C in the accompanying document in the docket,
``Vaccination and Testing ETS: Economic Profile and Cost Chapter
Appendices (OSHA, October, 2021b).''
b. Rule Familiarization, Employer Policy on Vaccination, and
Information Provided to Employees
ETS Requirements
Section 1910.501(d)(1) of the ETS specifies that the employer must
establish and implement a written mandatory vaccination policy. The
employer is exempted from the requirement in paragraph (d)(1) only if
the employer establishes and implements a written policy allowing any
employee not subject to a mandatory vaccination policy to either choose
to be fully vaccinated against COVID-19 or to provide proof of regular
testing for COVID-19 in accordance with paragraph (g) of the ETS and to
wear a face covering in accordance with paragraph (i) of the ETS.\43\
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\43\ Note to paragraph (d): Under federal law, including the
Americans with Disabilities Act (ADA) and Title VII of the Civil
Rights Act of 1964, some workers may be entitled to a reasonable
accommodation from their employer, absent undue hardship. If the
worker requesting a reasonable accommodation cannot be vaccinated
against COVID-19 and/or wear a face covering because of a
disability, as defined by the ADA, or if the vaccination, testing,
and/or wearing a face covering conflicts with the worker's sincerely
held religious belief, practice or observance, the worker may be
entitled to a reasonable accommodation. For more information about
evaluating requests for these types of reasonable accommodations for
disability or sincerely held religious belief, employers should
consult the Equal Employment Opportunity Commission's regulations,
guidance, and technical assistance including at: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
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In addition, under Sec. 1910.501(j), information provided to
employees, the ETS requires the employer to inform each employee, in a
language and at a literacy level the employee understand about: (1) The
requirements of the ETS as well as any employer policies and procedures
established to implement the ETS; (2) COVID-19 vaccine efficacy,
safety, and the benefits of being vaccinated; (3) the requirements of
29 CFR 1904.35(b)(1)(iv) and Section 11(c) of the OSH Act; and (4) the
prohibitions of 18 U.S.C. 1001 and Section 17(g) of the OSH Act.
As stated, the ETS face covering requirements are contained in
paragraph
(i) of the ETS. Under that paragraph, the employer, with certain
exceptions specified in the ETS, must ensure that each employee who is
not fully vaccinated wears a face covering when indoors and when
occupying a vehicle with another person for work purposes. The ETS does
not require, nor does it prohibit, the employer to pay for any costs
associated with face coverings (although employer payment for face
coverings may be required by other laws, regulations, or collective
bargaining agreements or other collectively negotiated agreements).
However, the employer must permit the employee to wear a respirator
instead of a face covering whether required or not. In addition, the
employer may provide respirators or face coverings to the employee,
even if not required. In such circumstances, where the employer
provides respirators, the employer must also comply with Sec.
1910.504, Mini respiratory protection program.
OSHA estimates no costs associated with an employee voluntarily
bringing in their own respirator to use instead of a face covering
other than those costs that OSHA is estimating below in connection with
29 CFR 1910.501(j), information provided to employees. That section
provides, again, that the employer must inform each employee, in a
language and at a literacy level the employee understands about the
requirements of the ETS as well as any employer policies and procedures
established to implement the ETS. One policy the employer would need to
establish to implement the ETS is a policy to comply with the
requirements of 29 CFR 1910.504 when an employee voluntarily brings in
their own respirator. Those requirements require only that the employer
provide certain information to the employee (see 29 CFR 1910.504(c)).
OSHA is also estimating no costs in connection with the employer
providing respirators to the employee. The ETS does not require the
employer to provide respirators to employees. Therefore, any such
provision is voluntary and not relevant to economic feasibility of this
rule.
The face covering provisions in paragraph (i) contain several other
requirements, none of which have costs associated with them.
Cost Analysis Assumptions
In this section, OSHA estimates the cost for establishing the
employer policy on vaccination, providing required information to
employees, and rule familiarization. OSHA assumes each entity will
require an average one-time labor burden of 1 hour of management labor
for rule familiarization. OSHA based this unit cost on that taken for
rule familiarization in the Healthcare ETS (86 FR at 32496), but
adjusted the time downward by a half-hour because this ETS is a simpler
standard than the Healthcare ETS.
To establish a written policy in accordance with paragraph (d) of
the ETS, OSHA assumes a one-time average labor burden of 5 hours of
manager time per firm. OSHA bases this estimate on its cost estimates
in the Healthcare ETS, where OSHA estimated that development of the
COVID-19 Plan required by that standard would take between 5 and 40
hours (see 86 FR at 32496-32497). OSHA concludes that 5 hours is a
reasonable estimate because the development of a written policy on
vaccination will be much simpler than the development of the written
COVID-19 Plan required by the Healthcare ETS (see 29 CFR
1910.502(c)).\44\ OSHA notes, that like the Healthcare ETS (id.), the
cost of implementing the plan for this ETS are included in the costs of
implementing the corresponding requirements in the ETS, which are
discussed below.
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\44\ The estimates for the time to create the written vaccine
policy plan under this ETS may differ from the time to create the
various processes under the CMS rule published elsewhere in this
issue of the Federal Register since the requirements of what is
needed to be included in the plans differ. For example, the CMS plan
requires a process for ensuring the implementation of additional
precautions to mitigate the transmission and spread of COVID-19
while OSHA's vaccination policy requirements do not include this
requirement.
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To provide information to employees in accordance with paragraph
(j) of the ETS, OSHA assumes a one-time average labor burden per firm
of 10 minutes of manager time. The agency expects activities like
posting the information on a community board, mass emailing, etc., will
satisfy this requirement.
The total cost for rule familiarization, establishing an employer
policy on vaccination and providing required information to employees
is calculated as the product of:
One-time labor burden for rule familiarization and
establishing a policy (a total of 6 hours of manager time per entity)
plus a one-time labor burden for providing information to employees (10
minutes of manager time per entity);
The labor rate for General and Operations Managers (SOC
code 11-1021, NAICS-specific wages); and,
The total number of covered entities.
Cost for Employer Policy on Vaccination and Information Provided to
Employees
Costs per entity and total costs for employer policy on vaccination and
information provided to employees are shown below in Table IV.B.9.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
c. Determining Employee Vaccination Status
ETS Requirements
Under Sec. 1910.501(e):
Paragraph (e)(1). The employer must determine the vaccination
status of each employee. This determination must include whether the
employee is fully vaccinated, which is 2 weeks after the full required
vaccine course is completed.
Paragraph (e)(2). The employer must require each vaccinated
employee to provide acceptable proof of vaccination status, including
whether they are fully or partially vaccinated. Acceptable proof of
vaccination status is:
The record of immunization from a health care provider or
pharmacy;
A copy of the COVID-19 Vaccination Record Card;
A copy of medical records documenting the vaccination;
A copy of immunization records from a public health,
state, or tribal immunization information system; or
A copy of any other official documentation that contains
the type of vaccine administered, date(s) of administration, and the
name of the health care professional(s) or clinic site(s) administering
the vaccine(s).
In instances where an employee is unable to produce acceptable
proof of vaccination, per above, a signed and dated statement by the
employee, subject to criminal penalties for knowingly providing false
information:
Attesting to their vaccination status (fully vaccinated or
partially vaccinated); and
Attesting that they have lost and are otherwise unable to
produce proof required by the ETS.
Paragraph (e)(3). Any employee who does not provide one of the
acceptable forms of proof of vaccination status in paragraph (e)(2) of
the ETS to the employer must be treated as not fully vaccinated for the
purpose of the ETS.
Paragraph (e)(4). The employer must maintain a record of each
employee's vaccination status and must preserve acceptable proof of
vaccination for each employee who is fully or partially vaccinated. The
employer must maintain a roster of each employee's vaccination status.
These records and roster are considered to be employee medical records
and must be maintained as such records in accordance with 29 CFR
1910.1020 and must not be disclosed except as required or authorized by
the ETS or other federal law. These records and roster are not subject
to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the ETS remains in effect.
Paragraph (e)(5). Finally, when an employer has ascertained
employee vaccination status prior to the effective date of this section
through another form of attestation or proof, and retained records of
that ascertainment, the employer is exempt from the requirements in
paragraphs (e)(1)-(e)(3) only for each employee whose fully vaccinated
status has been documented prior to the effective date of this section.
For purposes of paragraph (e)(4), the employer's records of
ascertainment of vaccination status for each such person constitute
acceptable proof of vaccination.
The full costs for these provisions are taken under the costs for
recordkeeping, discussed below, because determining vaccination status,
providing acceptable proof of vaccination status, and creating and
maintaining a roster of each employee's vaccination status will be part
and parcel of the recordkeeping process.
d. Employer Support for Employee Vaccination
ETS Requirements
Under 29 CFR 1910.501(f):
The employer must support COVID-19 vaccination by providing:
Time for vaccination. The employer must: (i) Provide a
reasonable amount of time to each employee for each of their primary
vaccination series dose(s); and (ii) provide up to 4 hours paid time,
including travel time, at the employee's regular rate of pay for this
purpose.
Time for recovery. The employer must provide reasonable
time and paid sick leave to recover from side effects experienced
following any primary vaccination series dose to each employee for each
dose.
Under the ETS, fully vaccinated means (i) a person's status 2 weeks
after completing primary vaccination with a COVID-19 vaccine with, if
applicable, at least the minimum recommended interval between doses in
accordance with the approval, authorization, or listing that is: (A)
Approved or authorized for emergency use by the FDA; (B) listed for
emergency use by the World Health Organization (WHO); or (C)
administered as part of a clinical trial at a U.S. site, if the
recipient is documented to have primary vaccination with the ``active''
(not placebo) COVID-19 vaccine candidate, for which vaccine efficacy
has been independently confirmed (e.g., by a data and safety monitoring
board), or if the clinical trial participant from the U.S. site had
received a COVID-19 vaccine that is neither approved nor authorized for
use by FDA but is listed for emergency use by WHO; or (ii) a person's
status 2 weeks after receiving the second dose of any combination of
two doses of a COVID-19 vaccine that is approved or authorized by the
FDA, or listed as a two-dose series by the WHO (i.e., heterologous
primary series of such vaccines, receiving doses of different COVID-19
vaccines as part of one primary series). The second dose of the series
must not be received earlier than 17 days (21 days with a 4-day grace
period) after the first dose.
Cost Analysis Assumptions
OSHA assumes there will be no costs to employers or employees
associated with the vaccine itself.\45\ However, to provide support for
vaccination of employees, OSHA estimates that it will take an average
of 15 minutes of travel time, each way, per employee to travel to a
vaccination site (for a total of 30 minutes). OSHA then estimates 5
minutes to wait, fill out any necessary paperwork, and receive the
shot, and a post-shot wait time of 20 minutes, per employee. Some
firms, particularly larger ones, will find it cheaper to have vaccines
administered on site. They may have an on-site health clinic or may
hire a 3rd party purveyor to come to the facility.\46\ This will
minimize travel and also allow the companies to mitigate some of the
logistical issues that may be preventing employees from receiving a
vaccine (finding a convenient appointment time, etc.). OSHA estimates
that 10 percent of firms with employees between 100 to 500 employees
will select this option, while, given decreased average costs
associated with economies of scale, 25 percent of firms with over 500
employees will select this option. OSHA was unable to obtain an
estimate of the cost savings associated with on-site vaccination in the
time allotted to issue this emergency standard, so it is assuming that
the costs for off-site vaccination are the same as the costs for on-
site vaccination. This results in a likely over-estimate of costs given
that the entities that choose the on-site option will do so as a cost-
saving measure.
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\45\ While there may be some administrative costs borne by the
government, such costs are not germane to this analysis of whether
the ETS is economically feasible for covered employers.
\46\ Prior to the effective date of this rule, some companies
offered on-site vaccination according to a limited survey. (Willis
Towers Watson, June 23, 2021). See also CDC on creating an on-site
program (CDC, March 25, 2021; CDC, October 4, 2021b).
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In OSHA's cost analysis, OSHA assumes that all employees will be
vaccinated during working hours and employers would adjust the employee
work schedule to ensure that the employee would not become eligible for
overtime pay as a result of the vaccination time. However, it should be
noted that, if an employee chooses to receive the vaccine outside of
work hours, OSHA does not require employers to grant paid time to the
employee for the time spent receiving the vaccine during non-work hours
(although other laws may include additional requirements for employers,
such as those addressing reasonable accommodations or exemptions).
OSHA's analysis may be an overestimate as it reflects an assumption
that all vaccinations are received during work hours.
CDC data indicated that 5 percent of employees vaccinated have
received the Johnson & Johnson vaccine, and 95 percent have received
either Pfizer or Moderna (CDC, October 2021b). OSHA applies the same
allocation to employees being vaccinated under the ETS. For those
receiving Pfizer or Moderna, the labor burden outlined
above occurs twice, since vaccination requires two shots.
The employer must provide reasonable time and paid sick leave to
recover from side effects experienced following any vaccination dose to
each employee for each vaccination dose. Employers may require
employees to use paid sick leave benefits otherwise provided by the
employer to offset these costs, if available. The average amount of
time off an employee may need for side effects while receiving the
vaccine doses necessary to achieve full vaccination (one or two doses,
depending on the vaccine) depends on several factors. First, the
percentage of people who will have side effects that are severe enough
to require time. Second, the average time duration for those who have
such a severe reaction. For estimates of these parameters OSHA is using
a recent study (Levi et al., September 29, 2021) which surveyed workers
at a state-wide health care system who had been vaccinated. The study
found that, for the first dose, 4.9% needed administrative leave, with
an average length of absence of 1.66 days. For the second dose, 19.79%
needed leave and their average length of absence was 1.39 days.
Together, the average time on leave is .36 days (.049 * 1.66 + .1979 *
1.39) for a person receiving two doses, which reflects the fact that
many people who receive the vaccine do not have any side effects for
either dose while others have more severe side effects.
In order to determine the amount of paid sick leave that would be
available to employees, OSHA relied on data from BLS (BLS, 2021e). BLS
estimates that for civilian workers in establishments with 100+
employees, 88% have access to paid sick leave (Table 33). BLS states
that the average number of paid sick leave available is 9 days (Table
36). Because there is the same number of days across all levels of
employee tenure (1 year, 5 years, 10 years, and 20 years), OSHA used 9
days for all covered employees. The agency assumes that 75% of the
available paid sick leave has been used by the current 4th quarter of
the calendar year. So the average number of days available is 1.98
days: 9 (days) * 88% (employees with available paid sick leave) * 25%
(amount of leave remaining in the year) = 1.98 days available. Given
that the average overall time out due to side effects is 0.36 days (see
above), OSHA concludes that, on average, employees should have
sufficient existing paid sick leave available to cover the time needed
as a result of vaccine-related side effects. As a result, OSHA is
taking no costs to employers in connection with the ETS's requirement
to provide time for recovery from vaccination (except as provided
below), as these costs will have been incurred by the employer
independent of the ETS.
While this analysis is entirely consistent with OSHA's standard
procedure of strictly using averages in cost analysis, it nonetheless
masks some significant effects resulting from the time for recovery
requirements. From the BLS data, OSHA knows there are 12% of
establishments that have 100+ employees and do not provide paid sick
leave. Correspondingly, there is a group of entities with no paid sick
leave that will obviously incur costs that result directly from these
requirements. In addition, some employees may not have, or some other
entities may not offer, sufficient paid sick leave to cover these
costs.
To account for the 12 percent of firms that do not offer paid sick
leave, the agency uses the above estimate of average days for two
doses, 0.36 days, and multiplies the average employee wage by NAICS to
calculate the cost per employee. Since OSHA does not know which firms
make up the 12 percent, the agency spreads this total cost across all
firms by employee. Since firms without any sick leave are likely to be
lower-wage firms, this will likely lead to a cost overestimate.
Therefore, the total cost for paid time off for vaccination is
based on the costs for providing paid sick leave for the 12 percent of
firms that do not offer paid sick leave and:
Travel time per employee of covered firms of 15 minutes
each way per vaccination dose (total of 30 minutes).
Pre-shot wait time per employee of covered firms of 5
minutes per vaccination dose.
Post-shot wait time per employee of covered firms of 20
minutes per vaccination dose.\47\
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\47\ According to the CDC, people with allergies require a wait
time of 30 minutes, but they are a small group, and, in any event,
the CDC recommends that routine wait time is 15 minutes, so the
agency considers that its average of 20 minutes is probably an
overestimate. (See CDC, October 4, 2021a; CDC, March 3,2021.)
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The average labor rate for employees (NAICS-specific
wages).
Total number of employees at covered firms getting
vaccinated due to the ETS with the Johnson & Johnson vaccine.
Total number of employees at covered firms getting
vaccinated due to the ETS with the Pfizer and Moderna vaccines,
multiplied by two to account for two shots.
Cost for Support for Employee Vaccination
Costs per firm and total costs for vaccination are shown below in
Table IV.B.10.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
e. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
ETS Requirements
Section 1910.501(g)(1) of the ETS requires the employer to ensure
that each employee who is not fully vaccinated do the following:
An employee who reports at least once every 7 days to a workplace
where other individuals, such as coworkers or customers, are present:
Must be tested for COVID-19 at least once every 7 days;
and
Must provide documentation of the most recent COVID-19
test result to the employer no later than the 7th day following the
date on which the employee last provided a test result.
An employee who does not report during a period of 7 or more days
to a workplace where other individuals, such as coworkers or customers,
are present (e.g., teleworking for two weeks prior to reporting to a
workplace with others):
Must be tested for COVID-19 within 7 days prior to
returning to the workplace; and
Must provide documentation of that test result to the
employer upon return to the workplace.
Furthermore, if an employee does not provide documentation of a
COVID-19 test result as required by paragraph (g)(1) of the ETS, the
employer must keep that employee removed from the workplace until they
provide a test result. In addition, when an employee has received a
positive COVID-19 test, or has been diagnosed with COVID-19 by a
licensed healthcare provider, the employer must not require that
employee to undergo COVID-19 testing as required under paragraph (g) of
this section for 90 days following the date of their positive test or
diagnosis. Finally, the employer must maintain a record of each test
result provided by each employee under paragraph (g)(1) of this section
or obtained during tests conducted by the employer. These records are
considered to be employee medical records and must be maintained as
such records in accordance with 29 CFR 1910.1020 and must not be
disclosed except as required or authorized by this section or other
federal law. These records are not subject to the retention
requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
preserved while this section remains in effect.
OSHA addresses the costs associated with testing in the next
section. The remaining costs required by paragraph (g) are taken under
the costs for recordkeeping, discussed below, because providing
documentation of test results to the employer will be part and parcel
of the recordkeeping process.
Employees who are partially vaccinated are also required to be
tested weekly until they are fully vaccinated. Those receiving the J&J
vaccine will require two weeks of testing after the single shot,
employees who received the Pfizer-BioNTech Vaccine will require 5 weeks
of testing (3 weeks between shots and 2 weeks following the second
shot), and Moderna recipients require 6 weeks of testing (4 weeks
between shots and 2 weeks following the second shot) (CDC, October 4,
2021b). Notwithstanding this, in the agency's total cost estimate OSHA
accounts for the fact that employers need not comply with the
requirements of this section in paragraph (g) by 60 days after the
rule's effective date, and that employees who have completed the entire
primary vaccination series by that date do not have to be tested, even
if they have not yet completed the 2 week waiting period.
There is no requirement in the rule that the employer pay for this
testing so these testing-related costs are not included in the main
analysis (although, as discussed below OSHA takes into account costs
for testing in connection with the ETS's recordkeeping requirements).
The agency estimates that 6.3 million weekly tests will need to be
given due to this ETS (see Table IV.B.8). This 6.3 million is likely an
overestimate of new costs because it encompasses tests for employees
who were already required to conduct testing by their employers prior
to this ETS.
OSHA also notes that its cost estimates for testing do not take
into account the 90-day break in testing that occurs following the date
of a positive test or diagnosis. OSHA's cost estimates are also
potentially overcounting costs in that OSHA does not take into account
that not all employees for whom testing is required will report at
least once every 7 days to a workplace where other individuals, such as
coworkers or customers, are present. Thus, OSHA's estimate assumes that
employees for whom testing is required will need to be tested at least
once every 7 days and not less frequently as will often be the case.
OSHA notes, in addition, that there are no costs associated with
paragraph (g)'s removal provision. The ETS does not require the
employer to provide paid time off to any employee for removal as a
result of the employee's refusal/failure to provide documentation of a
COVID-19 test result as required by paragraph (g)(1) of the ETS.
Finally, OSHA notes that a COVID-19 test under the ETS is a test
for SARS-CoV-2 that is: (i) Cleared, approved, or authorized, including
in an Emergency Use Authorization (EUA), by the FDA to detect current
infection with the SARS-CoV-2 virus (e.g., a viral test); (ii)
Administered in accordance with the authorized instructions; and (iii)
Not both self-administered and self-read unless observed by the
employer or an authorized telehealth proctor. Examples of tests that
satisfy this requirement include tests with specimens that are
processed by a laboratory (including home or on-site collected
specimens which are processed either individually or as pooled
specimens), proctored over-the-counter tests, point of care tests, and
tests where specimen collection and processing is either done or
observed by an employer. Employers may have costs associated with
doing, observing or proctoring employee testing, if employers choose to
do so. However, for economic feasibility purposes, OSHA does not
account for these costs in its estimates because they are not required
for compliance with the ETS.
Costs Associated with Reasonable Accommodation: Testing, Face
Coverings, and Determinations
The ETS does not require the employer to pay for any costs
associated with testing; however employer payment for testing may be
required by other laws, regulations, or collective bargaining
agreements. Thus, while OSHA does not include any costs for reasonable
accommodation requests in its main cost analysis in recognition that
such costs would result from the application of other laws, OSHA notes
that even if employers were to agree to pay for COVID-19 testing as
part of a reasonable accommodation or some other reason required by
law, such costs would not alter OSHA's findings regarding the economic
feasibility of the rule.\48\ OSHA reached this conclusion after
conducting a separate analysis of reasonable accommodation costs that
an employer might assume if they do not represent an undue hardship for
the employer. This analysis is available in the docket at OSHA, October
2021d.
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\48\ OSHA notes that while the testing required under this
standard might be an option for employees who request a reasonable
accommodation to avoid vaccination, other alternatives such as
telework would be more protective to the employee by preventing
COVID-19 exposure. These alternatives may also be available at no
additional cost to the employer or employee.
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OSHA notes that this separate analysis is limited to employees who
request accommodation, and accounts for costs of reviewing medical and/
or religious accommodation requests, as
well as costs for COVID-19 testing and face coverings that would
satisfy the requirements of this ETS. OSHA expects a reasonable
accommodation request could lead to a review of the employee's request
by a manager and then a conference between the manager and the
employee. OSHA concludes that the combination of these costs would not
alter OSHA's findings regarding the economic feasibility of the ETS.
f. Employee Notification to Employer of a Positive COVID-19 Test and
Removal
ETS Requirements
Under Sec. 1910.501(h):
Regardless of COVID-19 vaccination status or any COVID-19 testing
required under paragraph (g) of the ETS, the employer must:
Require each employee to promptly notify the employer when
they receive a positive COVID-19 test or are diagnosed with COVID-19 by
a licensed healthcare provider; and
Immediately remove from the workplace any employee who
receives a positive COVID-19 test or is diagnosed with COVID-19 by a
licensed healthcare provider and keep the employee removed until the
employee: (i) Receives a negative result on a COVID-19 nucleic acid
amplification test (NAAT) following a positive result on a COVID-19
antigen test if the employee chooses to seek a NAAT test for
confirmatory testing; (ii) meets the return to work criteria in CDC's
``Isolation Guidance'' (incorporated by reference, Sec. 1910.509); or
(iii) receives a recommendation to return to work from a licensed
healthcare provider.
Costs Analysis Assumptions
The ETS does not require employers to provide paid time off to any
employee for removal from the workplace as a result of a positive
COVID-19 test or diagnosis of COVID-19; however paid time off may be
required by other laws, regulations, or collective bargaining
agreements or other collectively negotiated agreements. Therefore,
there are no costs associated with paragraph (h)'s removal provision.
With respect to notification, to the extent employee notification
is connected to the ETS's testing and documentation requirements in
paragraph (g), those costs to the employer are taken under the costs
for recordkeeping, discussed below, because, as explained above,
receiving documentation of test results under paragraph (g) will be
part and parcel of the recordkeeping process.
OSHA notes also that the costs associated with employee
notification by vaccinated employees (not required by this ETS to
undergo testing) should also be negligible because it will not occur
with any real frequency. The very low breakthrough rates of infection
among vaccinated persons suggests that the overwhelming majority of
COVID-19 cases reported to a covered employer will be in the pool of
unvaccinated employees.
g. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
ETS Requirements
Under Sec. 1910.501(j):
The employer must report to OSHA:
Each work-related COVID-19 fatality within 8 hours of the
employer learning about the fatality.
Each work-related COVID-19 in-patient hospitalization
within 24 hours of the employer learning about the in-patient
hospitalization.
When reporting COVID-19 fatalities and in-patient hospitalizations
to OSHA in accordance with paragraph (j)(1) of the ETS, the employer
must follow the requirements in 29 CFR part 1904.39, except for 29 CFR
part 1904.39(a)(1) and (2) and (b)(6).
Cost Analysis Assumptions
OSHA estimates a total of 1,464 fatalities and 59,570
hospitalizations for employees of covered firms.\49\ This analysis is
broadly consistent, using updated data, with OSHA's analysis of a
nearly identical provision in 29 CFR 1910.502, the Healthcare ETS. OSHA
also estimates, based on the Healthcare ETS, that reporting of each
fatality and hospitalization will require 45 minutes of an employer's
time (86 FR at 32516). This includes hospitalizations and fatalities
for employees that remain unvaccinated, as well as a small percentage
of hospitalizations and fatalities of vaccinated employees due to
breakthrough cases. Because of the timing requirements in the rule, the
agency assumes that a hospitalization followed by a death will need two
reports from the employer (i.e., the agency assumes that reporting for
hospitalizations will occur within 8 hours, before reporting for
fatalities occurs, within 24 hours). This will result in a slight over-
estimate.
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\49\ These counts represent hospitalizations and fatalities that
would occur to the in-scope labor force despite the ETS. The numbers
are derived using methodology similar to that used in Health Impacts
to generate hospitalizations and fatalities prevented. An infection
rate and case fatality rate are multiplied by the number of
unvaccinated workers to derive a total number of fatalities. That
number is used to derive hospitalizations. The number of
hospitalizations and fatalities to vaccinated employees is
calculated in a similar fashion, but with a lower infection rate
because vaccination makes it considerably less likely that an
individual will be tested and found to be infected. See (OSHA,
October 2021a and OSHA, October 2021c). One difference in
methodology between these counts and the Health Impacts analysis is
that these counts use a baseline of the last 19 months of CDC data
to estimate the case fatality rate (similar to Alternative C in the
Health Impacts analysis), rather than a baseline of the last 6
months (which OSHA used for the main Health Impacts analysis). This
results in an estimate toward the upper bound for these counts
(i.e., an overestimate of costs).
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The total cost for reporting COVID-19 fatalities and
hospitalizations to OSHA is calculated as the product of:
One-time labor burden of 45 minutes per report of
hospitalization or fatality.
Wage range for General and Operations Managers (SOC code
11-1021, NAICS-specific wages).
Total number of fatalities for employees at covered firms.
Total number of hospitalizations for employees at covered
firms.
Cost for Reporting COVID-19 Fatalities and Hospitalizations to OSHA
Costs per entity and total costs for vaccination are shown below in
Table IV.B.11.
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h. Recordkeeping
ETS Requirements
As discussed above, the full costs for the requirements in
paragraph (e) of the ETS are taken under the costs for recordkeeping
because determining vaccination status, providing acceptable proof of
vaccination status, and creating and maintaining a roster of each
employee's vaccination status will be part and parcel of the
recordkeeping process. Under paragraph (e)(4) of the ETS, the employer
must maintain a record of each employee's vaccination status and must
preserve acceptable proof of vaccination for each employee who is fully
or partially vaccinated. The employer must also maintain a roster of
each employee's vaccination status. These records and roster are
considered to be employee medical records and must be maintained in
accordance with 29 CFR 1910.1020 as such records and must not be
disclosed except as required or authorized by the ETS or other federal
law. These records and roster are not subject to the retention
requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
preserved while the ETS remains in effect.
With respect to vaccination, it should be noted that, under
paragraph (e)(5) of the ETS, when an employer has ascertained employee
vaccination status prior to the effective date of this section through
another form of attestation or proof, and retained records of that
ascertainment, the employer is exempt from the determination of
vaccination requirements in paragraphs (e)(1)-(e)(3)
only for each employee whose fully vaccinated status has been
documented prior to the effective date of this section. For purposes of
the recordkeeping requirements in paragraph (e)(4), the employer's
records of ascertainment of vaccination status for each such person
constitute acceptable proof of vaccination. OSHA estimates, based on
this provision, that 60% of employees who were vaccinated prior to the
promulgation of the ETS will not need to document vaccination status in
connection with paragraph (e) (ASU COVID-19 Diagnostic Commons, October
6, 2021).
As also discussed above, the costs for the requirements for
documenting test results in paragraph (g), including the timing for
when recordkeeping costs for testing accrue under the ETS, are taken
under the costs for recordkeeping because providing documentation of
test results to the employer will be part and parcel of the
recordkeeping process. Under paragraph (g)(4) of the ETS, the employer
must maintain a record of each test result provided by each employee
under paragraph (g)(1) of the ETS or obtained during tests conducted by
the employer. These records must be maintained in accordance with 29
CFR 1910.1020 and must not be disclosed except as required or
authorized by this section or other federal law. These records are not
subject to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but
must be maintained and preserved while this section remains in effect.
With respect to testing, it should be noted that, under paragraph
(m) of the ETS, employers are not required to comply with the
requirements in paragraph (g) of the ETS until 60 days after the
effective date of the ETS, meaning that for cost analysis purposes OSHA
assumes that employers would not receive any testing records until the
end of that 60-day period.
Finally, under paragraph 1910.501(l)(1) of the ETS, availability of
records, by the end of the next business day after a request, the
employer must make available, for examination and copying, the
individual COVID-19 vaccine documentation and any COVID-19 test results
for a particular employee to that employee and to anyone having written
authorized consent of that employee. In addition, under paragraph
1910.501(l)(2) of the ETS, by the end of the next business day after a
request by an employee or an employee representative, the employer must
make available to the requester the aggregate number of fully
vaccinated employees at a workplace along with the total number of
employees at that workplace. Under paragraph 1910.501(l)(3) of the ETS,
the employer must also provide to the Assistant Secretary for
examination and copying: (i) Within 4 business hours of a request, the
employer's written policy required by paragraph (d) of the ETS, and the
aggregate numbers described in paragraph (l)(2) of the ETS; and (ii) By
the end of the next business day after a request, all other records and
other documents required to be maintained by the ETS.
Cost Analysis Assumptions
To fulfill the recordkeeping requirements in the ETS, OSHA
estimates that it will take an average of 5 minutes of clerical time
per employee record. OSHA bases this cost estimate on the estimate for
recordkeeping in the Healthcare ETS (86 FR at 32515). While OSHA
estimated an average of 10 minutes of clerical time per employee record
in the Healthcare ETS, that standard includes more extensive
recordkeeping requirements than what is being required under this ETS.
See 29 CFR 1910.502(q)(2)(ii) (Healthcare ETS record must contain, for
each instance, the employee's name, one form of contact information,
occupation, location where the employee worked, the date of the
employee's last day at the workplace, the date of the positive test
for, or diagnosis of, COVID-19, and the date the employee first had one
or more COVID-19 symptoms, if any were experienced).
In addition, OSHA includes in this estimate 5 minutes of employee
time to provide documentation of vaccination status or testing, as
applicable, to the employer. OSHA notes that, for an employee who is
vaccinated, the employer will determine the vaccination status of that
employees and obtain acceptable proof of vaccination status at the same
time, thus negating the need to create two separate records for these
requirements.
OSHA notes that there will be a cost associated with setting up the
recordkeeping system (e.g., a spreadsheet) used to comply with the ETS.
OSHA takes these costs in connection with the costs for the employer
policy on vaccination, which are described above.
Given the relative complexity of recordkeeping in the Healthcare
ETS, OSHA has simplified its assumptions to reflect a variety of small
costs in a combined estimate. As in the Healthcare ETS, the cost
estimate of 5 minutes per event is likely much higher than necessary to
account for just the actions of receiving and maintaining copies of
records, so retaining this time will yield a tendency toward
overestimation. However, this cost also reflects a margin to encompass
additional outlier costs such as a second documentation of vaccination
status for all employees who need to submit documentation twice (first
for partial vaccination and then for full vaccination) under the ETS.
This 5 minutes for recordkeeping also encompasses the marginal time for
creating and maintaining a roster of each employee's vaccination status
(paragraph (e)) and making aggregate employee data available (paragraph
(l)). Since normally the system used for recordkeeping will be
electronic in businesses with more than 100 employees, the time to
create an aggregate report and a roster should be de minimis. Finally,
this inflated recordkeeping cost encompasses time for employee
notification to the employer of a positive COVID-19 test connected to
the ETS's testing and documentation requirements in paragraph (g),which
is a notification under paragraph (h). Finally, the burden of making
available, for examination and copying, the individual COVID-19 vaccine
documentation and any COVID-19 test results for a particular employee
are included in this estimate because this documentation will normally
be pulled from the electronic recordkeeping system described above.\50\
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\50\ The cost of providing to the Assistant Secretary for
examination and copying the employer's written policy required by
paragraph (d) of the ETS will be de minimis.
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The total cost for these requirements is calculated based on:
One-time labor burden of 5 minutes of employee labor to
provide documentation and 5 minutes of clerk labor per employee record
(one record per test administered and one record per documentation of
vaccination status).
The average labor rate for Office Clerks, General (SOC 43-
9060, NAICS-specific wages) and employees providing documentation
(average wage over all employees, NAICS-specific wages)
Total number of employees at covered firms getting
vaccinated due to the ETS with the Johnson & Johnson vaccine, who
receive one shot.
Total number of employees at covered firms getting
vaccinated due to the ETS with the Pfizer-BioNTech and Moderna
vaccines, multiplied by two to account for two shots.
Total number of tests for employees at covered firms who
are unvaccinated and will get vaccinated by receiving the Johnson and
Johnson vaccine.
Total number of tests for employees at covered firms who
are unvaccinated and will get vaccinated by receiving the Pfizer and
Moderna vaccines.
Total number of employees at covered firms who are
unvaccinated and will be tested weekly.
Cost for Recordkeeping
Costs per entity and total costs for recordkeeping are shown below
in Table IV.B.12.
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i. Summary of Total Cost
Total Cost and Total Cost per Entity
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j. Sensitivity Analysis
As stated above, based on limited data on current vaccine mandate
implementation and forecasts for future implementation (Mishra and
Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
2021), OSHA estimates that 25 percent of firms in scope currently have
a vaccination mandate, and assumes that this will rise to 60 percent of
covered employers after the ETS is in place. Because the agency has no
historic reference on which to base its assumptions regarding vaccine
mandates, the agency adjusted the percentage of firms that will
institute a vaccine mandate because of the ETS as part of a sensitivity
analysis. Along with
the baseline estimate of 60 percent of firms having a mandate, the
agency looked at a vaccine mandate rate of 40 percent and 80 percent
for covered firms, which OSHA judged to be a reasonable range based on
the data available. The total costs associated with a 40 percent
vaccine mandate are $2.998 billion, and the total costs associated with
an 80 percent vaccine mandate are $2.964 billion. This compares to the
baseline costs associated with a 60 percent vaccine mandate of $2.981
billion. A higher vaccine mandate increases the share of employees who
get vaccinated while reducing the share that must get weekly testing.
It is this shift in shares that causes the costs to change because the
total costs associated with weekly testing (recordkeeping) are more
expensive than the total costs associated with vaccination under the
ETS (employer support for vaccination, recordkeeping).
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Barry J et al. (2021, September 24). Unvaccinated Workers Say They'd
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Bick A et al. (2021, February). Work from Home Before and After the
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Brynjolfsson E et al. (2020, June). COVID-19 and Remote Work: An
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Cerullo M. (2021, August 31). The New Return Office Date for Google?
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Chesto J. (2021, June 22). Almost 40 percent of remote workers in
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Chokshi N and Scheiber N. (2021, October 2). Inside United Airlines'
Decision to Mandate Coronavirus Vaccines. The New York Times.
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Courtney E. (2021, September 27). 30 Companies Switching to Long-
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Dingel J and Neiman B. (2020, July). How many jobs can be done at
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Graham R. (2021, September 15). Vaccine Resistors Seek Exemptions.
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Groenewold M et al., (2020, July 10). Increases in Health-Related
Workplace Absenteeism Among Workers in Essential Critical
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Kaiser Family Foundation (KFF). (2021, June 30). KFF COVID-19
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30, 2021)
Kelly J. (2021, August 12) Study Shows That 44% Of Employees Would
Quit If Ordered To Get Vaccinated. https://www.forbes.com/sites/jackkelly/2021/08/12/study-shows-that-44-of-employees-would-quit-if-ordered-to-get-vaccinated/. (Kelly, August 12, 2021)
KEZI News. (2021, September 25). Here's How Many Oregon State
Employees Have Requested a COVID Vaccine Exemption. https://www.kezi.com/content/news/Heres-how-many-Oregon-state-employees-have-requested-a-COVID-vaccine-exemption-575395141.html. (KEZI News,
September 25, 2021)
Kuhn P and Yu L. (2021, April). How Costly is Turnover? Evidence
from Retail. Journal of Labor Economics 39(2), 461-496. https://doi.org/10.1086/710359. (Kuhn and Yu, April, 2021)
Lazer D et al. (2021, August 16). The COVID States Project: A 50-
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Levi M et al. (2021, September 29). COVID-19 mRNA vaccination,
reactogenicity, work-related absences and the impact on operating
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Mishra D and Hartstein B. (2021, August 23). Littler COVID-19
Vaccine Employer Survey Report--Delta Variant Update. https://www.littler.com/publication-press/press/littler-survey-employers-increasingly-consider-vaccine-mandates-covid-19. (Mishra and
Hartstein, August 23, 2021)
National Agricultural Statistics Service (NASS). (2017). Census of
Agriculture. https://www.nass.usda.gov/Quick_Stats/CDQT/chapter/1/table/1. (NASS, 2017)
O'Sullivan J. (2021, September 18). Washington state workers are
getting exemptions to avoid the COVID-19 vaccine--but will they keep
their jobs? Seattle Times. https://www.seattletimes.com/seattle-news/politics/washington-state-workers-are-getting-exemptions-to-avoid-the-covid-19-vaccine-but-will-they-keep-their-jobs/.
(O'Sullivan, September 18, 2021).
Occupational Safety and Health Administration (OSHA). (2021,
September 25). State Plans. https://www.osha.gov/stateplans/faqs.
(OSHA, September 25, 2021)
Occupational Safety and Health Administration (OSHA). (2021a,
October). Analytical Spreadsheets in Support of the COVID-19
Vaccination and Testing ETS. (OSHA, October 2021a)
Occupational Safety and Health Administration (OSHA). (2021b,
October). COVID-19 Vaccination and Testing ETS: Economic Profile and
Cost Chapter Appendices. (OSHA, October 2021b)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
Occupational Safety and Health Administration (OSHA). (2021d,
October). Costs Associated with Reasonable Accommodation: Testing,
Face Coverings, and Determinations. (OSHA, October 2021d)
Portnoy J. (2021, October, 3). Several hundred Virginia health-care
workers have been suspended or fired over coronavirus vaccine
mandates. The Washington Post. https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. (Portnoy, October 3, 2021)
Putri W et al. (2018, June, 22). Economic burden of seasonal
influenza in the United States. Vaccine 36(27), 3960-3966. https://www.sciencedirect.com/science/article/pii/S0264410X18306777?via%3Dihub. (Putri et al., June 22, 2018)
Umland B. (2021, October 13). Survey Looks at Vaccine Mandates and
Employee Turnover. Mercer. https://www.mercer.us/our-thinking/healthcare/survey-looks-at-vaccine-mandates-and-employee-turnover.html. (Umland, October 13, 2021)
U.S. Census Bureau. (2019). Statistics of U.S. Businesses (SUSB).
https://www.census.gov/programs-survey/susb.html. (U.S. Census
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U.S. Census Bureau. (2021). Household Pulse Survey (HPS), Week 37
Table 6A. https://www.census.gov/programs-surveys/household-pulse-survey/data.html. (U.S. Census Bureau, 2021)
White C. (2021). Measuring Social and Externality Benefits of
Influenza Vaccination. Journal of Human Resources Vol 56 Number 3,
pp. 749-785. https://muse.jhu.edu/article/798143. (White, 2021)
Willis Towers Watson. (2021, June 23). COVID-19 Vaccination and
Reopening the Workplace Survey. https://www.willistowerswatson.com/en-US/Insights/2021/06/covid-19-vaccination-and-reopening-the-workplace-survey. (Willis Towers Watson, June 23, 2021)
V. ETS Economic Feasibility Determination
a. OSHA's Screening Tests for Economic Feasibility
As noted in the introduction to the economic analysis, an OSHA
standard is economically feasible when industries can absorb or pass on
the costs of compliance without threatening industry's long-term
profitability or competitive structure, Cotton Dust, 452 U.S. at 530
n.55, or ``threaten[ing] massive dislocation to, or imperil[ing] the
existence of, the industry.'' United Steelworkers of Am. v. Marshall
(Lead I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
To determine whether a rule is economically feasible, OSHA
typically begins by using two screening tests to determine whether the
costs of the rule are beneath the threshold level at which the economic
feasibility of an affected industry might be threatened. The first
screening test is a revenue test. While there is no hard and fast rule
on which to base the threshold, OSHA generally considers a standard to
be economically feasible for an affected industry when the annualized
costs of compliance are less than one percent of annual revenues. The
one-percent revenue threshold is intentionally set at a low level so
that OSHA can confidently assert that the rule is economically feasible
for industries that are below the threshold (i.e., industries for which
the costs of compliance are less than one percent of annual revenues).
To put the one-percent threshold into perspective, OSHA calculated the
average compounded annual rate of growth or decay in average revenues
over the 15-year period from 2002 to 2017 (inflated to 2005 to 2020
dollars) for firms with 100 or more employees in the 479 NAICS (out of
546) industries covered by this ETS for which Census data were
available and found that the average annual real rate of change in
revenues in absolute terms for the average firm was 2.2 percentage
points a year.\51\ In other words, revenues are generally observed to
change by well more than one percent per year, on average, for firms
with 100 or more employees in covered industries, indicating that
changes of this magnitude are normal in these industries and that
covered firms are typically able to withstand such changes over the
course of a year, much less six months. As discussed below, the average
percentage change due to this ETS for all covered NAICS is a fraction
of this fluctuation in revenues.
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\51\ These results are presented in the Excel ETS Revenue
Threshold Test Tables available in the Docket for this ETS. The data
used for six-digit NAICS were from the Bureau of the Census,
available every five years (2002, 2007, 2012, 2107).
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The second screening test that OSHA traditionally uses to consider
whether a standard is economically feasible for an affected industry is
if the costs of compliance are less than ten percent of annual profits
(see, e.g., OSHA's economic analysis of its Silica standard, 81 FR
16286, 16533 (March 25, 2016); upheld in N. Am.'s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 300 (D.C. Cir. 2017)). The ten-percent profit
test is also intended to be at a sufficiently low level so as to allow
OSHA to identify industries that might require further examination.
Specifically, the profit screen is primarily used to alert OSHA to
potential impacts on industries where the price elasticity of demand
does not allow for ready absorption of new costs in higher prices
(e.g., industries with foreign competition where the American firms
would incur costs that their foreign competitors would not because they
are not subject to OSHA requirements). In addition, setting the
threshold for the profit test low permits OSHA to reasonably conclude
that the rule would be economically feasible for industries below the
threshold. To put the ten-percent profit threshold test into
perspective, evidence used by OSHA in its 2016 OSHA silica rule
indicates that, for the combined affected manufacturing industries in
general industry and maritime from 2000 through 2012, the average year-
to-year fluctuation in profit rates (both up and
down) was 138.5 percent (81 FR 16545).\52\
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\52\ Profits are subject to the dynamics of the overall economy.
Many factors, including a national or global recession, a downturn
in a particular industry, foreign competition, or the increased
competitiveness of producers of close domestic substitutes are all
easily capable of causing a decline in profit rates in an industry
of well in excess of ten percent in one year or for several years in
succession (See OSHA, March 24, 2016).
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When an industry ``passes'' both the ``cost-to-revenue'' and
``cost-to-profit'' screening tests, OSHA is assured that the costs of
compliance with the rule are economically feasible for that industry.
The vast majority of the industries covered by the ETS fall into this
category.
A rule is not necessarily economically infeasible, however, for the
industries that do not pass the initial revenue screening test (i.e.,
those for which the costs of compliance with the rule are one percent
or more of annual revenues), the initial profit screening test (i.e,
those for which the costs of compliance are ten percent or more of
annual profits), or both. Instead, OSHA normally views those industries
as requiring additional examination as to whether the rule would be
economically feasible (see N. Am.'s Bldg. Trades Unions v. OSHA, 878
F.3d at 291). OSHA therefore conducts further analysis of the
industries that ``fail'' one or both of the screening tests in order to
evaluate whether the rule would threaten the existence or competitive
structure of those industries (see United Steelworkers of Am., AFL-CIO-
CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)).
Time Parameters for Analysis
OSHA's economic analyses almost always measure the costs of a
standard on an annual basis, conducting the screening tests by
measuring the cost of the standard against the annual profits and
annual revenues for a given industry. One year is typically the minimum
period for evaluating the status of a business; for example, most
business filings for tax or financial purposes are annual in nature.
Some compliance costs are up-front costs and others are spread over
the duration of the ETS; regardless, the costs of the rule overall will
not typically be incurred or absorbed by businesses all at once.
However, OSHA does not expect that the ETS will require employers to
incur initial capital costs for equipment to be used over many years
(which would typically be addressed through installments over a year or
a longer period to leverage loans or payment options to allow more time
to marshal revenue and minimize impacts on reserves).
The compliance costs for this ETS are for a temporary rule for a
period of six months (which, again, is the time period that OSHA
assumes this ETS will last, solely for economic purposes). While OSHA
believes the most appropriate screens would be based on annual profits
and revenue, it has followed the more cautious route of basing the
screens on 6 months of profits and revenues to avoid any potential
uncertainty about whether the ETS is economically feasible for the
industries covered by this ETS. Using one year of revenues and profits
as the denominators in the cost-to-revenue and cost-to-profit ratios
would have resulted in ratios that are half of the estimated ratios
presented in this analysis. It is therefore unsurprising that
businesses in some number of NAICs have edged above the profit-
thresholds using a 6 month screen (as will be discussed later), and
OSHA believes that edging above the screening thresholds is less of an
indicator of economic peril in this context than in the context of a
permanent rulemaking analysis. Nevertheless, OSHA has examined each of
the NAICS that did not clear either of these conservative screening
tests and has concluded that the ETS is economically feasible for each
one.
Data Used for the Screening Tests
The estimated costs of complying with the ETS, which OSHA relied
upon to examine feasibility is based on the two tests described above
(see OSHA, October 2021a). The revenue numbers used to determine cost-
to-revenue ratios were obtained from the 2017 Economic Census for firms
with 100 or more employees in covered industries. This is the most
current information available from this source, which OSHA considers to
be the best available source of revenue data for U.S. businesses.\53\
OSHA adjusted these figures to 2020 dollars using the Bureau of
Economic Analysis's GDP deflator, which is OSHA's standard source for
inflation and deflation analysis.
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\53\ For information regarding the standards and practices used
by the Census Bureau to ensure the quality and integrity of its
data, see (US Census Bureau, October 8, 2021a; US Census Bureau,
October 8, 2021b).
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The profit screening test for feasibility (i.e., the cost-to-profit
ratio) was calculated as ETS costs divided by profits. Profits were
calculated as profit rates multiplied by revenues. The before-tax
profit rates that OSHA used were estimated using corporate balance
sheet data from the Internal Revenue Service (IRS), 2013 Corporation
Source Book (IRS, 2013). The IRS discontinued the publication of these
data after 2013, and therefore the most current years available are
2000-2013.\54\ The most recent version of the Source Book represents
the best available evidence for these data on profit rates.\55\
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\54\ See IRS, 2013.
\55\ OSHA also investigated Bizminer and RMA as potential
sources of profit information and determined that they do not
represent adequate and random samples of the affected industries.
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For each of the years 2000 through 2013, OSHA calculated profit
rates by dividing the ``net income'' from all firms (both profitable
and unprofitable) by total receipts from all firms (both profitable and
unprofitable) for each NAICS.\56\ OSHA then averaged these rates across
the 14-year (2000 through 2013) period. Since some data provided by the
IRS were not available at disaggregated levels for all industries and
profit rates, data at more highly aggregated levels were used for some
industries; that is, where data were not available for each six-digit
NAICS code, data for the corresponding four- or five-digit NAICS codes
were used. Data were used for all firms in the NAICS (as opposed to
just firms with 100 or more employees) since data disaggregated by
employment size-class were not available. Profit rates are expressed as
a percentage (see OSHA, October 2021a). Profits themselves were used to
calculate the cost-to-profit estimates for all firms contained in a
particular NAICS code (see OSHA, October 2021a).
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\56\ There is one code reported per tax entity and it may not be
representative to the six-digit level. See Corporation Sourcebook on
limitations of the industry classification for details. (IRS, 2013).
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OSHA has estimated costs over a 6-month timeframe for this ETS. As
discussed above, OSHA has therefore used six months of revenue to
conduct the cost-to-revenue tests and six months of profit to conduct
the cost-to-profit tests.
General Use of Revenues and Profits To Measure Economic Feasibility
As with other OSHA rulemaking efforts, the agency relies on the two
screening tests (costs less than one percent of revenue and costs less
than ten percent of profit) as an initial indicator of economic
feasibility. OSHA has generally found that the cost-to-revenue test is
a more reliable indicator of feasibility simply because the revenue
data are more accurate than the profit data. There are several reasons
for this.
First, OSHA has been using corporate balance sheet data from the
IRS as the best available evidence for estimating
corporate profits for years.\57\ Nevertheless, because firms typically
have an incentive to minimize their tax burden, it is reasonable to
expect that some of the reported accounting data may have been
strategically adjusted to reduce reported profits and their associated
tax implications. Business profits are much more likely to reflect such
strategic accounting than business revenues; accordingly, revenues are
a more accurate measure than profits for evaluating economic
feasibility for a multitude of reasons.\58\
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\57\ OSHA funded and accepted a final report by Contractor Henry
Beale (Beale Report, 2003) that reviewed alternative financial data
sources and concluded that the IRS data were the best. Since then
OSHA has been relying on IRS data to provide the financial data to
support its rulemaking analyses. See, for example, Occupational
Safety and Health Administration (OSHA) (2016), Final Economic and
Regulatory Flexibility Analysis for OSHA's Rule on Occupational
Exposure to Respirable Crystalline Silica, Chapter VI, pp. VI-2 to
VI-3, Docket No. OSHA-2010-0034-4247 (OSHA, March 24, 2016), which
includes a more recent review of data sources for corporate
financial profit data and further support for OSHA's choice of IRS
data.
\58\ In fact, all other Department of Labor agencies rely solely
on revenues to assess economic impacts, such as Regulatory
Flexibility Act certifications, in their rulemakings (see, e.g.,
Employment and Training Administration, Final Rule on Strengthening
Wage Protections for the Temporary and Permanent Employment of
Certain Aliens in the United States, https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and Hour
Division, Tip Regulations Under the Fair Labor Standards Act (FLSA),
https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28555.pdf).
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Second, because OSHA is using data from both profitable and
unprofitable firms, the average profit rate for a small number of
industries is negative (as described above, using 14 years of data that
predate the pandemic). This result could have occurred because of the
way profits are calculated, which unnaturally skews average profit
rates downward by including firms that have large losses (negative
profits) or subnormal profits and have already closed or are in the
process of closing, irrespective of any action by OSHA. The negative
rates could also be the result of macroeconomic fluctuations during the
14-year period used to determine the average, a period in which some of
these industries may have experienced unusually adverse financial
impacts (see, e.g., the explanation in Chapter VI, pp. VI-20 of the
Final Economic and Regulatory Flexibility Analysis for OSHA's Rule on
Occupational Exposure to Respirable Crystalline Silica, Docket No.
OSHA-2010-0034-4247, which notes the skew from negative impacts during
recession years (OSHA, March 24, 2016)). Or they could result from tax-
related incentives, as previously noted.
Whatever the reason, the cost-to-profit calculations for NAICS with
negative profit rates fail to provide reliable information about the
long-term profitability of these industries, independent of the ETS.
Companies and industries that consistently lose money do not typically
stay in business, and would almost certainly not still be in business
in 2021 if that loss continued at the same level for each of the 8
years since the profit data was published in 2012. Revenue streams are
a more dependable measure for those firms because those streams tend to
be more stable and more indicative of the actual capabilities of
sustainable firms than reported negative profit margins. As a result,
for the purposes of this analysis, OSHA has relied more heavily on its
cost-to-revenue estimates, in lieu of cost-to-profit estimates, as the
more reliable indicator for economic feasibility for the industries
with negative profit rates.
Third, and similarly, profit rates that are only slightly positive
(i.e., less than one percent) are inconclusive and not useful for the
purpose of OSHA's cost-to-profit test. In economics terms, profit
entails a reasonable rate of return on investment, and long-term
profits of less than one percent a year are not generally reasonable
for firms that expect to remain in business. Thus data showing
industry-wide profits in this range do not measure the true ability of
companies to pay for the ETS costs. As previously stated, revenue
streams tend to be more stable and more indicative of the actual
capabilities of sustainable firms. Therefore, where possible, OSHA
prefers to rely on the cost-to-revenue test to evaluate economic
feasibility for industries that have a less than one percent profit
rate.
The qualification, and by far the most important reason for the
general primacy of revenues versus profits as the appropriate metric
for determining economic feasibility, for most OSHA rules, is that the
regulated firms are able to pass on the costs of the rule in the form
of higher prices. When they cannot, the profit test functions primarily
as a screen for a limited purpose: Alerting OSHA to potential impacts
where unregulated competitors can prevent firms from passing costs
along to customers.
To understand this point, some economic background is needed. The
price elasticity of demand refers to the relationship between the price
charged for a product or service and the quantity demanded for that
product or service: The more elastic the relationship, the larger the
decrease in the quantity demanded for a product when the price goes up.
When demand is elastic, establishments have less ability to pass
compliance costs on to customers in the form of a price increase and
must absorb such costs in the form of reduced profits. In contrast,
when demand is relatively inelastic, the quantity demanded for the
product or service will be less affected by a change in price. In such
cases, establishments can recover most of the variable costs of
compliance (i.e., costs that are highly correlated with the amount of
output) by raising the prices they charge; under this scenario, if
costs are variable rather than fixed, business activity and profit
rates are largely unchanged for small changes in costs. Ultimately,
where demand is relatively inelastic, any impacts are primarily borne
by those customers who purchase the relevant product or service for a
slightly higher price. Most of the costs of this ETS are variable costs
because they depend primarily on the level of production or the number
of employees at an establishment. For example, under the ETS, a firm
with 500 employees must determine and record the vaccination status of
500 employees, while a firm with 250 employees need determine and
record the vaccination status of only 250 employees.\59\
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\59\ While fixed cost can be more limiting in terms of options
for businesses, most of the costs of this rule are not fixed.
Instead, most of the compliance costs vary with the level of output
or employment at a facility.
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In general, ``[w]hen an industry is subjected to a higher cost, it
does not simply swallow it; it raises its price and reduces its output,
and in this way shifts a part of the cost to its consumers and a part
to its suppliers'' (Am. Dental Ass'n v. Sec'y of Labor, 984 F.2d 823,
829 (7th Cir. 1993)). A reduction in output could happen in a variety
of ways: Individual establishments could reduce their levels of service
(e.g., retail firms) or production (e.g., manufacturing), both of which
could take the form of a reduction of worker hours; some marginal
establishments could close; or, in the case of an industry with high
turnover of establishments, new entry could be delayed until demand
equals supply. In many cases, a decrease in overall output for an
industry will be a combination of all three kinds of reductions. The
primary means of achieving the reduction in output most likely depends
on the rate of turnover in the industry and on the form that the costs
of the regulation take. Further, the temporary nature of the ETS and
its associated
costs suggests that firms may have more flexibility to respond than
when facing a permanent increase in costs. For example, firms may be
able to temporarily increase prices or temporarily defer planned
capital expenditures or other maintenance to cover compliance costs.
There are two situations typically mentioned when an industry
subject to regulatory costs might be unable to pass those costs on: (1)
Foreign competition not subject to the regulation, or (2) domestic
competitors in other industries, not subject to the regulation, that
produce goods or services that are close substitutes. Otherwise, when
all affected domestic industries are covered by a rule and foreign
businesses must also comply with the rule or are unable to compete
effectively, the ability of a competing industry to offer a substitute
product or service at a lower price is greatly diminished.
There is a third situation that is relevant to this ETS--when only
some firms in a domestic industry (in this case, only employers with
100 or more employees) are subject to the ETS and its regulatory costs.
In principle, competition from smaller employers in a NAICS could
prevent the larger employers from passing on their costs in the form of
higher prices and instead require them to absorb the costs in the form
of lost profits. There are, however, several important caveats:
1. As a practical matter, it is implausible to expect that covered
employers (with 100 or more employees) would feel constrained by
smaller competitors in their industry so as not to pass on costs for a
rule lasting 6 months that imposes costs equal to 0.02 percent of
revenues, on average across all NAICS, over that time period (see OSHA,
October 2021a). This time period would likely be too short for small
firms to expand to take business away from the larger firms or for new
firms to form to take advantage of such minor and transitory business
opportunities. Furthermore, smaller firms (particularly very small
firms--those with fewer than 20 employees) typically can't compete on
price with large firms that have cost advantages due to various
economies of scale; as a result, smaller firms often serve a
specialized niche market rather than compete directly with larger
firms. To the extent that this ETS creates new business opportunities
for these smaller uncovered firms, they would also be covered by the
ETS as soon as they reached 100 employees.\60\
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\60\ This cost advantage may be exaggerated or non-existent in
many cases (see the discussion directly below in the text in Caveat
2).
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2. An important factor to consider in calculating the costs and
impacts and economic feasibility of this ETS is the unquantified and
unmonetized cost savings and other positive economic impacts accruing
to employers that comply with the ETS. These include reduced
absenteeism due to COVID-19 illnesses \61\ and quarantine.\62\ Other
positive economic impacts that compliant employers would enjoy from a
safer business environment are increased retail trade from customers
that feel less at risk and better relations with suppliers and other
business partners. These all would contribute to improved business and
increased profits.
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\61\ Several occupational groups less able to avoid exposure to
SARS-CoV-2 infection exhibited significantly higher rates of
absenteeism in March-April 2020 compared to earlier periods
(Groenewold et al., July 10, 2020).
\62\ For a discussion of turnover (i.e. whether the ETS could
affect the likelihood that an employee will remain with an employer,
either because the imposition of a vaccine requirement will lead
some employees to leave and find employment at an establishment not
subject to the ETS, or, alternatively, to stay due to a preference
for enhanced COVID-19 safety procedures), please see the cost
section (Section III.d.) of this economic analysis.
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3. The existence of these cost savings and other positive economic
impacts accruing to employers that comply with the ETS suggests that
the actual net costs of the ETS will be much lower than the costs
reported in the supporting economic analysis for this ETS used to
estimate cost impacts and demonstrate economic feasibility. In fact,
for some share of covered employers, the net costs of the ETS may well
be negative. Indeed, this is being confirmed by revealed preference in
the market. Elsewhere in the economic analysis for this ETS (Cost
Analysis section 4.2), OSHA has provided evidence to support its
estimate that 25 percent of covered employers already voluntarily
require that their employees be vaccinated and a much larger percentage
are considering a vaccine mandate. This strongly supports the
conclusion that these businesses agree that doing so will ultimately
save costs.
b. Economic Feasibility Analysis and Determination
This section summarizes OSHA's feasibility findings for industries
covered by the ETS. As stated previously, the agency uses two screening
tests (costs less than one percent of revenue and costs less than ten
percent of profit) as an initial indicator of economic feasibility. In
this section, OSHA discusses the industries that fall above the
threshold level for either screening test.
The overall effect of compliance with the general section of the
ETS on covered industries is very small (see OSHA, October 2021a). The
vast majority of the covered NAICS have very low cost-to-revenue and
cost-to-profit ratios, with the overall averages being 0.02 percent of
revenues and 0.49 percent of profits. To put this into perspective, if
the average firm decided to raise prices to cover the costs of the ETS,
the price of a $100 product or service, for example, would have to be
increased by 2 cents (during the six-month period).
Based on the information presented here, the costs of the ETS are
below both the threshold revenue test (1 percent of revenues) and the
threshold profit test (10 percent of profits) for the vast majority of
NAICS industries.\63\ This indicates that the average firm in these
industries will be able either to raise prices to cover ETS costs or to
absorb the costs of the ETS out of available profits. In either case,
OSHA concludes that the ETS is economically feasible for all of these
industries.
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\63\ By OSHA's calculation, 524 out of the 546 six-digit NAICS
covered by the ETS.
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Critically, there are no industries covered by the general section
of the ETS that are above OSHA's cost-to-revenue threshold level of one
percent and most are a small fraction of this level. Because OSHA is
using data from both profitable and unprofitable firms, the average
profit rate for a small number of industries is negative. There are 14
NAICS with negative cost-to-profit ratios, resulting from negative
average profit rates. These industries with negative profit rates are
domestic service industries that are not subject to international
competition.
There are eight six-digit NAICS industries, covering all
establishments in those industries covered by the general section of
the ETS, with cost-to-profit ratios above 10 percent:
1. NAICS 221118--Other Electric Power Generation, 23.97 percent;
2. NAICS 488119--Other Airport Operations, 18.41 percent;
3. NAICS 488410--Motor Vehicle Towing, 15.75 percent;
4. NAICS 488490--Other Support Activities for Road Transportation,
14.32 percent;
5. NAICS 713920--Skiing Facilities, 13.16 percent; and
6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33
percent;
7. NAICS 713120--Amusement Arcades, 11.18 percent; and
8. NAICS 488320--Marine Cargo Handling, 10.03 percent.
The average profit rate reported over the 14 years for which OSHA
has profit data for all the NAICS affected by the ETS is 4.2 percent.
All of the eight NAICS industries with a cost-to-profit ratio above the
10 percent threshold report an annual profit rate below one percent--75
percent or more below the overall average for all NAICS covered by the
ETS. These eight industries all provide domestic services and are not
subject to international competition.
The fact that the covered firms in these 22 NAICS industries (the
14 with negative cost-to-profit ratios and the 8 with more sustainable
cost-to-profit ratios) exceeded the profit screen suggests that they
might in theory have difficulty paying for the costs of the ETS out of
profits gained over the six-month duration of the ETS if they had no
savings or access to capital, but even if that were true it would be
highly unlikely to place the firms in financial jeopardy. OSHA examines
these industries more closely below, but before even considering the
reasons in NAICs-specific analysis it is important to consider the
larger context. For the ETS to threaten the economic solvency of these
firms, the following 3 conditions must apply:
1. These firms must not enjoy certain cost savings and positive
economic impacts from the ETS that would partially or totally offset
their costs. This condition is questionable because of the estimated 25
percent of employers sampled that reported voluntarily imposing a
vaccine mandate and the substantial number more contemplating the
voluntary adoption of such a mandate. They can be expected to base
their decisions, partly or entirely, on anticipated cost savings or
positive economic impacts (which would reduce or eliminate their risk
of insolvency due to the ETS).
2. These firms (all with 100 or more employees) must not be able to
raise prices to cover ETS costs because of the threat that smaller
firms in their NAICS industry, not covered by the ETS, could underprice
them and take away their business. This condition is unlikely or
limited because of the economies of scale the larger firms enjoy and
the fact that the smaller firms out of necessity tend to serve a market
niche not in direct competition with the larger firms. Also, there is a
severe limit to the extent that firms with fewer than 100 employees can
take away significant portions of business from the larger firms
without becoming subject to the requirements of the rule themselves. If
the larger firms do not feel threatened by being underpriced by smaller
firms in these NAICS industries, then they could raise prices an
average of less than 0.05 percent \64\ to cover the cost of the ETS--a
small fraction of the 1.0 percent of revenues threshold (beneath which
OSHA has determined that economic feasibility is not a concern).
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\64\ If not underpriced by smaller firms, covered firms in the 8
NAICS industries reporting ETS costs above 10 percent of profits
could cover these costs by raising prices an average of 0.08 percent
(highest, 0.11 percent); covered firms in the 14 NAICS industries
reporting negative profits could cover ETS costs with a price
increase of 0.01 percent (highest, 0.02 percent).
---------------------------------------------------------------------------
3. These firms must not generate sufficient profits or have
adequate borrowing capacity during the six months the ETS is in force
to cover the costs of the ETS. There are several reasons to doubt that
this condition broadly applies. First, the estimates of business
profits come from corporate balance sheet data that firms report to the
IRS. But, as previously noted, it is generally the case that firms have
an incentive to minimize their tax burden, and it is reasonable to
expect that some of the reported accounting data may have been
strategically adjusted to reduce reported profits and their associated
tax implications. Another point concerning the IRS data is that they
include the negative profits of firms that are going out of business or
have since gone out of business. To the extent that these points are
true, many or most of the covered firms in these NAICS industries
(still in business) actually would generate sufficient profit to cover
the cost of the ETS. A related point is that for this condition to
apply, the firms must not be able to borrow the money to pay for the
costs of the ETS. Recall, however, that these are all large firms with
100+ employees. It is reasonable to expect that many or most firms of
this size in the 22 NAICS industries at issue either have available
funds or could obtain a short-term loan to cover costs equal to the
0.01 to 0.11 percent of revenues that these firms would incur over the
six-month period that OSHA assumes the ETS will remain in effect. Firms
of this size normally have banking relationships and some unencumbered
assets. They also have access to national and international capital
markets. If these firms can borrow funds to pay for the ETS, then the
profit restriction doesn't matter.
Finally, OSHA anticipates concern that limiting the scope of the
ETS to employers with 100 or more employees will somehow put these
larger firms in economic jeopardy from the smaller firms to which the
ETS does not currently apply. This is highly improbable for several
reasons discussed earlier, including the fact that these are large
employers with advantages of economies of scale and access to capital
and the fact that this is a temporary standard that would result, at
most, in marginal impacts over 6 months (on average, equal to costs of
0.02 percent of revenues, which, again, translates to a cost increase
of a penny on a fifty dollar item).
But even that misses the main point: Economic feasibility refers to
the industry, not to the firm. OSHA must construct a reasonable
estimate of compliance costs and demonstrate a reasonable likelihood
that these costs will not threaten the existence or competitive
structure of an industry, even if it does portend disaster for some
marginal firms (Lead I, 647 F.2d at 1272). In the (again) highly
unlikely event that individual firms exit an industry and are replaced
by other firms in the industry, then the ETS would preserve the
economic feasibility of the covered industries. If an employer covered
by this standard actually had to increase its prices slightly to
account for the cost of this standard, there are two potential groups
of smaller businesses that could seek to supplant the covered firms.
The first group of businesses are much smaller than the covered firms.
Those businesses, however, will typically have higher costs and prices
to begin with due to their scale disadvantages to the larger firms. The
larger firm's small price increases attributable to this ETS would not
be likely to create an actionable competitive advantage for this group
of smaller businesses. The second group of businesses are those closer
in size to the 100-employee cutoff. If the marginal price increases did
actually cause some of the larger firms to fail and the slightly
smaller firms to take their place, the industry itself would not suffer
a massive dislocation or be imperiled. And, of course, if all of the
firms in an industry are large employers with 100 or more employees, no
competitive disadvantage from within the industry would exist (even
hypothetically), and there would be no question that they could cover
the cost of ETS by raising prices to customers accordingly.
Although the preceding discussion demonstrates that the ETS is
economically feasible, OSHA has provided an additional examination of
each of the NAICS that have crossed the profit screen (again noting
that none of
these failed the revenue screen): The eight NAICS industries with
positive profit ratios but profit rates below 1 percent.
1. NAICS 221118--Other Electric Power Generation, 23.97 Percent
This U.S. industry comprises establishments primarily engaged in
operating electric power generation facilities (except hydroelectric,
fossil fuel, nuclear, solar, wind, geothermal, biomass). These
facilities convert other forms of energy, such as tidal power, into
electric energy. The electric energy produced in these establishments
is provided to electric power transmission systems or to electric power
distribution systems.
Using tides to generate power is not yet economically viable,
according to one source, because ``[t]otal availability of tidal power
is restricted by its relatively high cost and limited number of sites
having high flow velocities and tidal ranges,'' although ``with [ ]
recent advancements in tidal technologies, the total availability of
tidal power in terms of turbine technology as well as design may be
higher than before, and the economic costs may be reduced significantly
to competitive levels.'' In support, in the same article, ``recent
reports state that the UK, which has the largest tidal and wave
resource in Europe, is capable of harnessing up to 153GW of tidal power
capacity with the help of three types of technologies and thus meeting
20% of current UK electricity demand and reducing carbon emissions.
Hence it is evident that wave and tidal energy could contribute more to
the increasing electricity demands across the globe.'' \65\
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\65\ See Walker, January 22, 2013.
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At the time OSHA obtained the most recent NAICS data, there were 7
affected entities in this NAICS industry. The entities in this NAICS
industry include firms like Berkshire Hathaway Energy Company, (with
annual sales of $19.8 billion, whose ``portfolio consists of locally
managed business that share a vision for a secure and sustainable
energy future''); Dominion Energy (with annual sales of $13.4 billion);
and other leading firms in this industry including some of the largest
power generation companies in the US (See NAICS Association, 2018a;
NAICS Association 2018d; and NAICS Association 2018e).
As this NAICS industry is not yet viable, (in the United States, at
least), it is to be expected that revenues and profits would be low. In
fact, OSHA believes the best way to view this industry is as a series
of incredibly well-funded start-up companies during the investment
phase of the business, where short-term losses are expected and offset
with the anticipation of enormous revenue growth potential (in an
acknowledged very limited energy market.) Given these factors, OSHA's
typical revenue and profit screen are a poor predictor of future
viability with respect to this NAICS industry (although, as pointed
out, this NAICS industry, like all other NAICS industries, falls well
below the revenue screen threshold). The estimated cost of this ETS per
firm is $866 in this NAICS industry, which equals about 11 cents per
hundred dollars of revenue over a limited six-month duration. OSHA
concludes that this industry will be able to withstand this small cost
in order to keep its workers protected during the pandemic.
2. NAICS 488119--Other Airport Operations, 18.41 Percent 66
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\66\ This U.S. industry comprises establishments primarily
engaged in (1) operating international, national, or regional
airports, or public flying fields or (2) supporting airport
operations, such as rental of hangar space, and providing baggage
handling and/or cargo handling services.
---------------------------------------------------------------------------
The services this industry offers are integrated into a particular
geographic location and entail specific tasks, such as parking and
baggage handling services, that must be done to ensure the proper
functioning of airports, thus negating the potential for substitution
during the 6 month period that OSHA is assuming the ETS will be in
effect for economic purposes. In addition, because these are services
that need to be done in particular domestic locations (i.e., airports),
there is no risk of international competition.
3. NAICS 488410--Motor Vehicle Towing, 15.75 Percent 67
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\67\ This industry comprises establishments primarily engaged in
towing light or heavy motor vehicles, both local and long-distance.
These establishments may provide incidental services, such as
storage and emergency road repair services.
---------------------------------------------------------------------------
The actual cost impacts on this industry are likely significantly
overstated to the extent that most employees performing towing services
ride alone in their trucks and their services do not typically require
exposure to others. In the event that individual large towing firms are
concerned about economic impacts, it would not be difficult to
structure their employee interactions with the company and customers to
take advantage of the scope restrictions. Moreover, the primary
services this industry offers involve the use of specialized vehicles
designed uniquely for towing, thus lowering the risk of substitution.
In addition, because these services are geographically based, there is
no risk of international competition.
4. NAICS 488490--Other Support Activities for Road Transportation,
14.32 Percent 68
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\68\ This industry comprises establishments primarily engaged in
providing services (except motor vehicle towing) to road network
users.
---------------------------------------------------------------------------
This industry offers services that must be done to ensure proper
operation of roadways (for example, bridge, tunnel, and highway
operations, pilot car services (i.e., wide load warning services),
driving services (e.g., automobile, truck delivery), and truck or
weighing station operations), thus negating the potential for
substitution. In addition, because these services need to be done in
particular domestic locations (i.e., roadways), there is no risk of
international competition.
5. NAICS 713920--Skiing Facilities, 13.16 Percent 69
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\69\ This industry comprises establishments engaged in (1)
operating downhill, cross country, or related skiing areas and/or
(2) operating equipment, such as ski lifts and tows. These
establishments often provide food and beverage services, equipment
rental services, and ski instruction services. Four season resorts
without accommodations are included in this industry.
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This industry caters to a wealthy clientele who ensure an inelastic
demand easily capable of absorbing any fractional increases
attributable to this ETS.\70\ In addition, skiing is done outdoors,
which will incentivize clientele to continue engaging in this
particular activity in lieu of indoor substitutions, during the
pandemic. Finally, there is little to no risk of international
competition from foreign ski resorts because the added and substantial
costs of international travel outweigh the costs associated with
marginally higher prices resulting from the ETS.
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\70\ See Brown, January 19, 2017, ``[o]f the 9.4 million skiers
in the U.S., more than half earn a salary higher than $100,000. For
some context, only 20 percent of American households have a combined
income of $100K. . . .'')
---------------------------------------------------------------------------
6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33 Percent
71
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\71\ This industry comprises establishments primarily engaged in
operating fitness and recreational sports facilities featuring
exercise and other active physical fitness conditioning or
recreational sports activities, such as swimming, skating, or
racquet sports.
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As these settings are generally located close to where clients live
or work, there is no risk of international competition. Some of the
largest employers in this industry have already responded to customer
feedback by not only requiring employees to be vaccinated, but also
members.\72\ This suggests both that the costs estimates attributed to
the ETS are overstated for these employers because higher levels of
compliance may have already occurred than projected in OSHA's analysis,
and that the ETS requirements reflect more of an industry trend than a
threat to the existence of the industry.
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\72\ See Jackson, August 2, 2021 ``Equinox also noted in the
press release that `an overwhelming majority of members' have
expressed support for a vaccination requirement for entry to Equinox
clubs.''
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7. NAICS 713120--Amusement Arcades, 11.18 Percent 73
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\73\ This industry comprises establishments primarily engaged in
operating amusement (except gambling, billiard, or pool) arcades and
parlors.
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This industry caters to a select clientele who have chosen to
engage in leisure activities in the unique settings offered by the
industry, thus negating the likelihood for substitution. In addition,
because these settings are localized, there is no risk of international
competition.
8. NAICS 488320--Marine Cargo Handling, 10.03 Percent 74
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\74\ This industry comprises establishments primarily engaged in
providing stevedoring and other marine cargo handling services
(except warehousing).
---------------------------------------------------------------------------
The services this industry offers are integrated into a particular
location and entail specific tasks, such as loading and unloading
services at ports and harbors, longshoremen services, marine cargo
handling services, ship hold cleaning services, and stevedoring
services, that must be done to ensure the proper movement of cargo off
of and onto ships, thus negating the potential for substitution. In
addition, because these are services that need to be done in particular
domestic locations (e.g., docks), there is no risk of international
competition.
As with towing, the actual cost impacts on this industry are likely
significantly overstated to the extent that some of the employees may
be able to perform their work exclusively outdoors.
The Fourteen NAICS Industries With Negative Profit Ratios
1. Air Transportation 75
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\75\ NAICS 481111 (Scheduled Passenger Air Transportation)
provides air transportation of passengers or passengers and freight
over regular routes and on regular schedules, including commuter and
helicopter carriers (except scenic and sightseeing). NAICS 481112
(Scheduled Freight Air Transportation) provides air transportation
of cargo without transporting passengers over regular routes and on
regular schedules, including scheduled air transportation of mail on
a contract basis. NAICS 481211 (Nonscheduled Chartered Passenger Air
Transportation) provides air transportation of passengers or
passengers and cargo with no regular routes and regular schedules.
NAICS 481212 (Nonscheduled Chartered Freight Air Transportation)
provides air transportation of cargo without transporting passengers
with no regular routes and regular schedules. NAICS 481219 (Other
Nonscheduled Air Transportation) provides air transportation with no
regular routes and regular schedules (except nonscheduled chartered
passenger and/or cargo air transportation). These establishments
provide a variety of specialty air transportation or flying services
based on individual customer needs using general purpose aircraft.
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NAICS 481111 (Scheduled Passenger Air Transportation), NAICS 481112
(Scheduled Freight Air Transportation), NAICS 481211 (Nonscheduled
Chartered Passenger Air Transportation), NAICS 481212 (Nonscheduled
Chartered Freight Air Transportation), NAICS 481219 (Other Nonscheduled
Air Transportation).
This group of NAICS industries is comprised of U.S. industries that
primarily engage in providing air transportation. There is little to no
risk of substitution for this group of NAICS industries. Air
transportation provides unique and important benefits that cannot be
substituted via other forms of transportation (e.g., rail, freight,
bus). (See ATAG, September 2005). To this end, air transportation is
often the speediest means of transporting passengers and cargo, giving
it a unique purpose that cannot be met by other forms of transport. It
should be noted that the five NAICS in this group of industries are the
only NAICS in NAICS 4811 (Scheduled Air Transportation) and 4812
(Nonscheduled Air Transportation). The other industries in NAICS 48
(Transportation) do not provide air transportation (See NAICS
Association, 2018b). This further reduces the risk of substitution, as
all five NAICS at issue have a negative profit ratio and therefore face
similar challenges that appear to be endemic to air transportation.
Firms in this industry that have been able to weather the pandemic this
long are typically highly capitalized or have access to loans, so it is
highly likely that they could also weather the temporary marginal costs
of OSHA's ETS.
There is also no risk of international competition with respect to
this group of NAICS industries because any workers, whether they work
for an international company or not, who are in the US, are subject to
US laws, including the ETS, and foreign air carriers will need to
follow the ETS for those workers. In addition, OSHA suspects that any
smaller foreign air carriers will not have an incentive to expand their
routes significantly or change their routes to domestic US routes to
take advantage of the 100-employee cutoff in the ETS in the 6-months
the ETS is assumed to be in effect.
2. Telecommunications 76
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\76\ NAICS 517311 (Wired Telecommunications Carriers) comprises
establishments primarily engaged in operating and/or providing
access to transmission facilities and infrastructure that they own
and/or lease for the transmission of voice, data, text, sound, and
video using wired telecommunications networks. Establishments in
this industry use the wired telecommunications network facilities
that they operate to provide a variety of services, such as wired
telephony services, including VoIP services; wired (cable) audio and
video programming distribution; wired broadband internet services;
and, by exception, establishments providing satellite television
distribution services using facilities and infrastructure that they
operate are included in this industry. NAICS 517312 (Wireless
Telecommunications Carriers (except Satellite)) comprises
establishments primarily engaged in operating and maintaining
switching and transmission facilities to provide communications via
the airwaves. Establishments in this industry have spectrum licenses
and provide services using that spectrum, such as cellular phone
services, paging services, wireless internet access, and wireless
video services. NAICS 517410 (Satellite Telecommunications)
comprises establishments primarily engaged in providing
telecommunications services to other establishments in the
telecommunications and broadcasting industries by forwarding and
receiving communications signals via a system of satellites or
reselling satellite telecommunications. NAICS 517911
(Telecommunications Resellers) comprises establishments engaged in
purchasing access and network capacity from owners and operators of
telecommunications networks and reselling wired and wireless
telecommunications services (except satellite) to businesses and
households. Establishments in this industry resell
telecommunications; they do not operate transmission facilities and
infrastructure. NAICS 517919 (All Other Telecommunications)
comprises establishments primarily engaged in providing specialized
telecommunications services, such as satellite tracking,
communications telemetry, and radar station operation, and also
includes establishments primarily engaged in providing satellite
terminal stations and associated facilities connected with one or
more terrestrial systems and capable of transmitting
telecommunications to, and receiving telecommunications from,
satellite systems, as well as establishments providing internet
services or Voice over internet protocol (VoIP) services via client-
supplied telecommunications connections.
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NAICS 517311 (Wired Telecommunications Carriers), NAICS 517312
(Wireless Telecommunications Carriers (except Satellite), NAICS 517410
(Satellite Telecommunications), NAICS 517911 (Telecommunications
Resellers), NAICS 517919 (All Other Telecommunications).
This group of NAICS industries is entirely comprised of U.S.
industries, except for NAICS 517410 (Satellite Telecommunications). All
of these industries provide specialized unique services in the
telecommunications industry that require specialized unique knowledge
and are thus resistant to substitution. While it is perhaps
possible that different forms of telecommunications might be
substituted for one another (e.g., the substitution of wired
telecommunications carriers for wireless telecommunications carriers),
the reality is that these different forms exist separately and feed
different markets and customer needs that are independent of the ETS.
Moreover, the five NAICS in this group of industries are the only NAICS
in NAICS 5173 (Wired and Wireless Telecommunications Carriers), NAICS
5174 (Satellite Telecommunications), and NAICS 5179 (Other
Telecommunications). The other industries in NAICS 51 (Information) are
not engaged in telecommunications (NAICS Association, 2018c). This
further reduces the risk of one industry substituting for the others,
as all five NAICS at issue have a negative profit ratio and therefore
face similar challenges that appear to be endemic to
telecommunications.
Moreover, three of the five NAICS industries in this group (NAICS
517311, 517312, 517410) operate or control the infrastructure needed
for engaging in the particular type of telecommunications in which
those industries engage. This not only fully negates the risk of
substitution, but also negates the risk of international competition
for these industries.
The other two industries in the group apparently do not operate or
control the infrastructure needed for telecommunications. However, the
telecommunications industry faces strict state and federal licensing
requirements, which severely limit the risk of competition both
internationally and from smaller firms seeking to take advantage of the
ETS's 100-employee cutoff. (See FCC, 2014; FCC, October 12, 2021a; FCC,
October 12, 2021b; Caltrans, October 12, 2021; and UTC, October 12,
2021).
3. Car and Equipment Rental 77
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\77\ NAICS 532111 (Passenger Car Rental) comprises
establishments primarily engaged in renting passenger cars without
drivers, generally for short periods of time. NAICS 532112
(Passenger Car Leasing) comprises establishments primarily engaged
in leasing passenger cars without drivers, generally for long
periods of time. NAICS 532120 (Truck, Utility Trailer, and RV
(Recreational Vehicle) Rental and Leasing comprises establishments
primarily engaged in renting or leasing, without drivers, one or
more of the following: Trucks, truck tractors, buses, semi-trailers,
utility trailers, or RVs (recreational vehicles). NAICS 532310
(General Rental Centers) comprises establishments primarily engaged
in renting a range of consumer, commercial, and industrial
equipment. Establishments in this industry typically operate from
conveniently located facilities where they maintain inventories of
goods and equipment that they rent for short periods of time. The
type of equipment that establishments in this industry provide often
includes, but is not limited to: Audio visual equipment,
contractors' and builders' tools and equipment, home repair tools,
lawn and garden equipment, moving equipment and supplies, and party
and banquet equipment and supplies.
---------------------------------------------------------------------------
NAICS 532111 (Passenger Car Rental), NAICS 532112 (Passenger Car
Leasing), NAICS 532120 (Truck, Utility Trailer), and RV (Recreational
Vehicle) Rental and Leasing) NAICS 532310 (General Rental Centers).
This group of industries rent motor vehicles (NAICS 532111, 532112,
532120) or equipment (NAICS 532310), for example, audio visual
equipment, contractors' and builders' tools and equipment, home repair
tools, lawn and garden equipment, moving equipment and supplies, and
party and banquet equipment and supplies, to individuals and
businesses, for personal and professional use. There is no risk of
substitution with respect to these industries, as these industries rent
specific items to those who want to use them. There is also no risk of
foreign competition with respect to these industries, as consumers and
businesses rent and pick up vehicles, as well as the type of equipment
offered for rent by NAICS 532310, from specific locations, including
car rental and other rental centers.
These industries have not been hard hit by the pandemic, as many
consumers have turned from group travel to individual transportation.
For example, RV rentals and leasing has soared during the pandemic,
which is not reflected in the pre-pandemic profit and revenue data
available for this analysis.\78\
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\78\ See Park, January 23, 2021.
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References
Air Transport Action Group (ATAG). (2005, September). The economic &
social benefits of air transport. https://www.icao.int/meetings/wrdss2011/documents/jointworkshop2005/atag_socialbenefitsairtransport.pdf. (ATAG, September 2005)
Beale HBR. (2003). Financial Data Sources. Microeconomic
Applications Inc. (Beale Report, 2003)
Brown J. (2017, January 19). Bring More Diversity to Skiing. https://www.powder.com/stories/opinion/extend-the-family/. (Brown, January
19, 2017)
Caltrans. (2021, October 12). Wireless Licensing Program, California
Department of Transportation. https://dot.ca.gov/programs/right-of-way/wireless-licensing-program. (Caltrans, October 12, 2021)
Federal Communications Commission (FCC). (2021, October 12a)
Licensing. https://www.fcc.gov/licensing-databases/licensing. (FCC,
October 12, 2021a)
Federal Communications Commission (FCC). (2021, October 12b)
Satellite. https://www.fcc.gov/general/satellite. (FCC, October 12,
2021b)
Groenewold M et al., (2020, July 10). Increases in Health-Related
Workplace Absenteeism Among Workers in Essential Critical
Infrastructure Occupations During the COVID-19 Pandemic--United
States, March-April 2020. Centers for Disease Control and Prevention
MMWR Vol. 69, No. 27. (Groenewold et al., July 10, 2020)
Internal Revenue Service (IRS). (2013). 2013 Corporation Source
Book. https://www.irs.gov/statistics/soi-tax-stats-corporation-source-book-us-total-and-sectors-listing. (IRS, 2013)
Jackson S. (2021, August 2). Gyms like Equinox and SoulCycle will
soon require members to show proof of vaccination to use their clubs
and studios. https://www.businessinsider.com/equinox-soulcycle-will-require-covid-19-vaccines-for-members-staff-2021-8. (Jackson, August
2, 2021)
NAICS Association. (2018a). NAICS Codes Description, 2018: 221118--
Other Electric Power Generation. https://www.naics.com/naics-code-description/?code=221118. Last accessed October 12, 2021. (NAICS
Association, 2018a)
NAICS Association. (2018b). Six Digit NAICS Codes and Titles, 2018:
Codes 48-49. https://www.naics.com/six-digit-naics/?code=48-49. Last
accessed October 12, 2021. (NAICS Association, 2018b)
NAICS Association. (2018c). Six Digit NAICS Codes and Titles, 2018:
Code 51. https://www.naics.com/six-digit-naics/?code=51. Last
accessed October 12, 2021. (NAICS Association, 2018c)
NAICS Association. (2018d). NAICS Profile Page, 2018: Berkshire
Hathaway Energy Co. https://www.naics.com/company-profile-page/?co=4973. Last accessed October 12, 2021. (NAICS Association, 2018d)
NAICS Association. (2018e). NAICS Profile Page, 2018: Dominion
Energy Inc. https://www.naics.com/company-profile-page/?co=11715.
Last accessed October 12, 2021. (NAICS Association, 2018e)
Occupational Safety and Health Administration (OSHA). (2016, March
24). Final Economic and Regulatory Flexibility Analysis for OSHA's
Rule on Occupational Exposure to Respirable Crystalline Silica,
Chapter VI, pp. VI-20. Docket No. OSHA-2010-0034-4247. (OSHA, March
24, 2016)
Occupational Safety and Health Administration (OSHA). (2021a,
October). Analytical Spreadsheets in Support of the COVID-19
Vaccination and Testing ETS. (OSHA, October 2021a)
Park S. (2021, January 23). RV sales soar during coronavirus
pandemic. https://www.foxbusiness.com/lifestyle/rv-sales-soar-during-pandemic-travel-road-trip. (Park, January 23, 2021)
U.S. Census Bureau. (2021, October 8a). Scientific Integrity.
https://www.census.gov/about/policies/quality/
scientific_integrity.html. (US Census Bureau, October 8, 2021a)
U.S. Census Bureau. (2021, October 8b). Statement of Commitment to
Scientific Integrity by Principal Statistical Agencies. https://www.census.gov/content/dam/Census/about/about-the-bureau/policies_and_notices/scientificintegrity/Scientific_Integrity_Statement_of_the_Principal_Statistical_Agencies.pdf. (US Census Bureau, October 8, 2021b)
Walker C. (2013, January 22). Is Tidal Power a Viable Source of
Energy? https://www.azocleantech.com/article.aspx?ArticleID=350.
(Walker, January 22, 2013)
Washington Utilities and Transportation Commission (UTC). (2021,
October 12). Eligible Telecommunications Carriers. https://www.utc.wa.gov/regulated-industries/utilities/telecommunications/federal-universal-service-funds/eligible-telecommunications-carriers. (UTC, October 12, 2021)
V. Additional Requirements
A. Regulatory Flexibility Act
Whenever an agency is required by the Administrative Procedure Act,
5 U.S.C. 553, or another law, to publish a general notice of proposed
rulemaking, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires the agency to prepare an initial regulatory flexibility
analysis (IRFA). 5 U.S.C. 601(2), 603(a). Since this ETS ``shall serve
as a proposed rule'' for a final standard under section 6(c)(3) of the
OSH Act, it is treated as a general notice of proposed rulemaking under
the RFA. An agency may waive or defer the IRFA in the event a rule is
promulgated in response to an emergency that makes compliance with the
requirements of section 603 impracticable. 5 U.S.C. 608(a). The agency
hereby certifies that compliance with the IRFA requirement is
impracticable under the circumstances. OSHA prepared this ETS on an
expedited basis in response to a national emergency affecting the lives
and health of the nation's workers; the IRFA is inherently a relatively
lengthy process that would be impracticable to undertake for a standard
of such broad applicability in the limited time available. Because OSHA
is not preparing an IRFA for the ETS, the agency is also not required
to convene a small entity panel under section 609(b).
B. Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1501 et seq.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1532, requires agencies to assess the anticipated costs and
benefits of a rule before issuing ``any general notice of proposed
rulemaking'' that includes a Federal mandate that may result in
expenditures in any one year by state, local, or Tribal governments, or
by the private sector, of at least $100 million, adjusted annually for
inflation. The assessment requirement also applies to ``any final rule
for which a general notice of proposed rulemaking was published.''
Although no general notice of proposed rulemaking was published, the
agency has analyzed the ETS's economic feasibility and health impacts
in Section IV.B. of this preamble (Economic Analysis) and Health
Impacts Appendix (OSHA, October 2021c).
C. Executive Order 13175
Section 5 of E.O. 13175, on Consultation and Coordination with
Indian Tribal Governments, requires agencies to consult with tribal
officials early in the process of developing regulations that: (1) Have
tribal implications, that impose substantial direct compliance costs on
Indian governments, and that are not required by statute; or (2) have
tribal implications and preempt tribal law. 65 FR 67249, 67250 (Nov. 6,
2000). E.O. 13175 requires that such consultation occur to the extent
practicable. Given the expedited nature of issuing the ETS, it was not
practicable for OSHA to consult and incorporate non-federal input prior
to promulgation of the standard. OSHA commits to meaningful
consultation with tribal representatives after publication of the ETS
and during the comment period before finalizing any permanent standard.
Such consultation will be consistent with the Administrative Procedure
Act.
D. National Environmental Policy Act
OSHA has reviewed this ETS according to the National Environmental
Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq., the regulations of
the Council on Environmental Quality, 40 CFR chapter V, subchapter A,
and the Department of Labor's NEPA procedures, 29 CFR part 11. As a
result of this review, the agency has determined that the rule will
have no significant impact on air, water, or soil quality; plant or
animal life; the use of land; or other aspects of the external
environment. Although the ETS contains testing requirements, and test
kits and supplies can generate some additional materials that will
enter the waste stream, the impact of this ETS will be minimal. As
discussed in more detail in Technological Feasibility (Section IV.A. of
this preamble), there is already a surplus of available tests, and
projected production of COVID-19 tests will be more than sufficient to
meet demands for testing created as a result of the rule. Therefore,
tests used for purposes of or for compliance with this ETS are not
being produced as a result of this standard, and the standard will not
generate significant new streams of waste beyond what would be
generated in the absence of the standard.
E. Congressional Review Act
This ETS is considered a major rule under the Congressional Review
Act (CRA), 5 U.S.C. 801 et seq. Section 801(a)(3) of the CRA normally
requires a 60-day delay in the effective date of a major rule. 5 U.S.C.
801(a)(3), 804(2). However, section 808(2) of the CRA allows the
issuing agency to make a rule effective sooner than otherwise provided
by the CRA if the agency makes a good cause finding that notice and
public procedure are impracticable, unnecessary, or contrary to the
public interest. 5 U.S.C. 808(2). OSHA finds that there is good cause
to make this rule effective upon publication because notice and public
procedure with respect to this ETS are both impracticable and contrary
to the public interest, given the expedited timeline on which this
standard was developed and the grave danger threatening workers' lives
and health (see Grave Danger and Need for the ETS, both in Section III.
of this preamble). Congress authorized OSHA to take swift action in
promulgating an ETS to address this type of grave danger, and provided
explicitly that an ETS is effective upon publication, 29 U.S.C.
655(c)(1); delaying the effective date of such an expedited process
would thwart that purpose. It is specifically because of the emergency
nature of this rulemaking that the OSH Act allows for OSHA to proceed
without the extensive public input the agency normally solicits in
issuing occupational safety and health standards. 29 U.S.C. 655(c)(1).
For rules to which section 808(2) applies, the agency may set the
effective date. In this case, consistent with the OSH Act requirement
cited above, the ETS takes immediate effect upon publication in the
Federal Register.
F. Administrative Procedure Act
The Administrative Procedure Act (APA) normally requires notice and
comment, and a 30-day delay of the effective date of a final rule, for
recordkeeping and reporting regulations promulgated under section 8(c)
of the OSH Act. 29 U.S.C. 657(c); 5 U.S.C. 553(b), (d). This ETS
contains recordkeeping and reporting requirements tailored to address
COVID-19 illness. To the extent that these requirements are not already
exempt from the APA's requirements for notice and comment under section
6(c) of the Act (29 U.S.C. 655(c)), OSHA invokes the ``good cause''
exemption to the APA's notice requirement because the agency finds that
notice and public procedure are impracticable and contrary to the
public interest under 5 U.S.C. 553(b)(B). As explained in more detail
in Grave Danger and Need for the ETS (both in Section III. of this
preamble), this finding is based on the critical importance of
implementing the requirements in this ETS, including the recordkeeping
and reporting provisions, as soon as possible to address the grave
danger that COVID-19 presents to workers.
As noted above, the ETS is required by the OSH Act to take
immediate effect upon publication. 29 U.S.C. 655(c)(1). For that
reason, and the underlying public health emergency that prompted this
ETS as discussed above, OSHA finds good cause to waive the normal 30-
day delay in the effective date of a final rule from the date of its
publication in the Federal Register. See 5 U.S.C. 553(d)(3). OSHA
notes, however, that OSHA does not require compliance with any
provision of the ETS within the first 30 days after it becomes
effective.
G. Consensus Standards
OSHA must consider adopting an existing national consensus standard
that differs substantially from OSHA's standard if the consensus
standard would better effectuate the purposes of the Act. See section
12(d)(1) of the National Technology Transfer and Advancement Act of
1995 (15 U.S.C.A. 272 Note); see also 29 U.S.C. 655(b)(8).
OSHA considered incorporation of ASTM F3502-21 in this ETS, as
required. However, the agency has insufficient evidence to make a
general finding of feasibility at this time. The agency notes that face
coverings that meet ASTM F3502-21 criteria also meet the definition of
``face coverings'' in this ETS (see the discussion of this issue in
Summary and Explanation, Section VI. of this preamble). The agency has
asked questions about this topic to gather additional information.
H. Executive Order 13045
Executive Order 13045, on Protection of Children from Environmental
Health Risks and Safety Risks, requires that Federal agencies
submitting covered regulatory actions to OIRA for review pursuant to
Executive Order 12866 must provide OIRA with (1) an evaluation of the
environmental health or safety effects that the planned regulation may
have on children, and (2) an explanation of why the planned regulation
is preferable to other potentially effective and reasonably feasible
alternatives considered by the agency (62 FR 19885 (April 23, 1997)).
Executive Order 13045 defines ``covered regulatory actions'' as rules
that may (1) be economically significant under Executive Order 12866,
and (2) concern an environmental health risk or safety risk that an
agency has reason to believe may disproportionately affect children.
Because OSHA has no reason to believe that the risk from COVID-19
disproportionately affects children, the ETS is not a covered
regulatory action and OSHA is not required to provide OIRA with further
analysis under section 5 of the executive order. However, to the extent
children are exposed to COVID-19 either as employees or at home as a
result of family members' workplace exposures to COVID-19, the ETS
should provide some protection for children.
I. Federalism
The agency reviewed this ETS according to Executive Order 13132, on
Federalism, which requires that Federal agencies, to the extent
possible, refrain from limiting State policy options, consult with
States before taking actions that would restrict States' policy
options, and take such actions only when clear constitutional authority
exists and the problem is of national scope. 64 FR 43255 (August 10,
1999). The Executive Order generally allows Federal agencies to preempt
State law only as provided by Congress or where State law conflicts
with Federal law. In such cases, Federal agencies must limit preemption
of State law to the extent possible.
The Occupational Safety and Health Act is an exercise of Congress's
Commerce Clause authority, and under Section 18 of the Act, 29 U.S.C.
667, Congress expressly provided that States may adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards. OSHA refers to States that obtain Federal
approval for such plans as ``State Plans.'' Occupational safety and
health standards developed by State Plans must be at least as effective
in providing safe and healthful employment and places of employment as
the Federal standards. As discussed below, State Plans must submit to
Federal OSHA for approval, standards that differ from Federal standards
addressing the same issues, in order for such standards to become part
of the OSHA-approved State Plan. Subject to these requirements, State
Plans are free to develop and enforce their own occupational safety and
health standards.
This ETS complies with E.O. 13132. The problems addressed by this
ETS for COVID-19 are national in scope. As explained in Grave Danger
(Section III.A. of this preamble), employees face a grave danger from
exposure to COVID-19 in the workplace. Employees across the country
face the danger of exposure to COVID-19 at work, and as explained in
Need for the ETS (Section III.B. of this preamble), a national standard
is needed to protect workers from the grave danger of COVID-19 by
strongly encouraging vaccination and limiting the presence of COVID-19
positive workers in the workplace through testing and to ensure that a
clear and consistent baseline approach is taken across the country to
protect them. The SARS-CoV-2 virus is highly communicable and infects
workers without regard to state borders, making a national approach
necessary. Accordingly, the ETS establishes minimum requirements for
employers in every State to protect employees from the risks of
exposure to COVID-19.
In States without OSHA-approved State Plans, Congress provides for
OSHA standards to preempt State occupational safety and health
standards for issues addressed by the Federal standards. In these
States, this ETS limits State policy options in the same manner as
every standard promulgated by the agency. Furthermore, as discussed in
the Summary and Explanation for Purpose, nothing in the ETS is intended
to limit generally applicable public health measures instituted by
state or local governments that go beyond, and are not inconsistent
with, the requirements of the ETS. (See Summary and Explanation for
Purpose, Section VI.A. of this preamble); Gade v. National Solid Wastes
Management Ass'n, 505 U.S. 88, 107 (1992). In States with OSHA-approved
State Plans, this ETS does not significantly limit State policy
options. Any special workplace problems or conditions in a State with
an OSHA-approved State Plan may be dealt with by that State's standard,
provided the standard is at least as effective as this ETS.
As discussed in the Summary and Explanation for Purpose in this
preamble, OSHA has included a provision that states the purpose of this
ETS, as well as OSHA's intent to preempt all inconsistent State and
local requirements that relate to the issues addressed by this ETS.
(See section 1910.501(a); Summary and Explanation for Purpose, Section
VI.A. of this preamble). This includes State and local
requirements banning or limiting the authority of employers to require
vaccination, face covering, or testing. As discussed in that section,
such State and local bans would be preempted by this ETS, even in
States with OSHA-approved State Plans, because such bans are not
approved by federal OSHA as part of the State Plan and could not be
approved, because such bans are clearly not as effective--and, indeed,
are contrary to--the federal ETS. See Indust. Truck Ass'n v. Henry, 125
F.3d 1305, 1311 (9th Cir. 1997).
J. State Plans
When Federal OSHA promulgates an emergency temporary standard,
States and U.S. Territories with their own OSHA-approved occupational
safety and health plans (``State Plans'') must either amend their
standards to be identical or ``at least as effective as'' the new
standard, or show that an existing State Plan standard covering this
area is ``at least as effective'' as the new Federal standard. 29 CFR
1953.5(b). This ETS imposes new requirements to protect workers across
the nation from COVID-19. Adoption of this ETS, or an ETS that is at
least as effective as this ETS, by State Plans must be completed within
30 days of the promulgation date of the final Federal rule, and State
Plans must notify Federal OSHA of the action they will take within 15
days. The State Plan standard must remain in effect for the duration of
the Federal ETS. As noted above in Federalism (Section V.I. of this
preamble), this ETS preempts all State and local requirements,
including in States with State Plans, that ban or limit the authority
of employers to require vaccination, face covering, or testing. (See
also the Summary and Explanation for Purpose, Section VI.A. of this
preamble). As with all non-identical State Plan standards, OSHA will
review any comparable State standards to determine whether they are at
least as effective as this ETS. A State Plan standard that prohibits
employers from requiring vaccination would not be at least as effective
as this ETS because OSHA has recognized in this ETS that vaccination is
the most protective policy choice for employers to adopt to protect
their workplaces.
Of the 28 States and Territories with OSHA-approved State Plans, 22
cover both public and private-sector employees: Alaska, Arizona,
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
Wyoming. The remaining six States and Territories cover only state and
local government employees: Connecticut, Illinois, Maine, New Jersey,
New York, and the Virgin Islands.
K. Paperwork Reduction Act
I. Overview
The Emergency Temporary Standard (ETS) for COVID-19 Vaccination and
Testing contains collection of information requirements that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501, et seq., and
OMB's regulations at 5 CFR part 1320. The PRA defines a collection of
information to mean the obtaining, causing to be obtained, soliciting,
or requiring the disclosure to third parties or the public, of facts or
opinions by or for an agency, regardless of form or format (44 U.S.C.
3502(3)(A)). OSHA has determined an ETS is necessary to protect workers
from the grave danger posed by COVID-19 and is issuing an ETS that
amends 29 CFR 1910 subpart U to provide COVID-19 protections to workers
of employers with 100 or more employees. Section 1910.501 contains
collections of information necessary to effectuate the purpose of the
ETS. The collections of information appear in paragraphs 1910.501(d),
(e)(2), (e)(4), (f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1), (k)(2),
(l)(1), and (l)(2). For a more comprehensive discussion of these
provisions, see the sectional analysis earlier in this preamble. These
information collections are applied by cross reference to other
industries in regulations 29 CFR 1915.1501 (Shipyard Employment),
1917.31 (Marine Terminals), 1918.110 (Longshoring), 1926.58
(Construction), 1928.21 (Agriculture).\79\
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\79\ The ETS applies to agricultural establishments with 11 or
more employees engaged on any day in hand-labor occupations in the
field and agricultural establishments that maintain a temporary
labor camp, regardless of how many employees are engaged on any day
in hand-labor occupations in the field).
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Under the PRA, a Federal agency cannot conduct or sponsor a
collection of information unless OMB approves it and the agency
displays a currently valid OMB control number (44 U.S.C. 3507).
Notwithstanding any other provision of law, if a collection of
information does not display a currently valid control number, an
employer shall not be subject to penalty for failing to comply with the
collection of information (44 U.S.C. 3512). The PRA has special
provisions for emergency situations that are applicable to this ETS.
OMB may authorize a collection of information without regard to the
normal clearance procedures if either (a) the relevant agency
determines that the collection of information is essential to the
mission of the agency and public harm is reasonably likely to result if
normal clearance procedures are followed, or (b) the use of normal
clearance procedures is reasonably likely to cause a statutory or court
ordered deadline to be missed (44 U.S.C. 3507(j) and 5 CFR 1320.13).
Because COVID-19 presents an ongoing public health threat to workers
and American businesses, OSHA has requested the use of these emergency
procedures for this ETS. In accordance with 44 U.S.C. 3507(j)(1), OMB
approved the request and assigned this ETS an OMB control number that
is valid for 180 days. Therefore, the information collection provisions
contained within this ETS will take effect at the same time as all
other provisions.
II. Summary of Information Collection Requirements
This information collection is summarized as follows.
1. Title: COVID-19 Vaccination and Testing Emergency Temporary
Standard (29 CFR 1910, subpart U; 1915, subpart Z; 1917, subpart B;
1918, subpart K; 1926, subpart D; 1928, subpart B).
2. Type of Review: Emergency.
3. OMB Control Number: 1218-0278.
4. Affected Public: This rule applies to employers with a total of
100 or more employees except where the workplace is covered under the
Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance
for Federal Contractors and Subcontractors; or in setting where the
employee provides healthcare services or healthcare support services
that falls under the requirements of 29 CFR 1910.502. This rule does
not apply to employees of covered employers who work from home,
exclusively outdoors, or who do not report to a workplace where other
individuals such as coworkers or customers are present.
5. Description of the ICR. This ICR contains collections of
information requirements for employers with 100 or more employees. The
employer must establish, implement, and enforce a written mandatory
vaccination policy that requires each employee to be fully vaccinated
against COVID-19 unless the employer implements a policy that allows
employees to choose between being fully vaccinated or both tested and
wearing a face covering. Employers must determine employee vaccination
status, and must require than any employees who are not vaccinated be
tested for COVID-19 at least once every
7 days. Employers must provide specified information to employees
regarding COVID-19 vaccine efficacy, safety, and the benefits of being
vaccinated, and must maintain a record of the COVID-19 vaccination
status, proof of vaccination, and copies of employee COVID-19 test
results, and the aggregate number of fully vaccinated employees at a
workplace along with the total number of employees at that workplace.
6. Number of respondents: 1,858,935.
7. Frequency: Varies.
8. Number of Responses: 205,262,803.
9. Estimated Burden Hours: 79,720,444.
10. Estimated Cost (Capital-operation and maintenance):
$1,383,751,520.
These totals are explained and supported in the agency's Supporting
Statement as required by the PRA.
III. Request for Comment
Although the ETS takes effect immediately, with implementation
dates specified in the Dates provision of this publication, it also
serves as a temporary standard that can only be made permanent
following an opportunity for public notice and comment. OSHA therefore
invites the public to submit comments to OSHA on the proposed
collections of information with regard to the following.
Whether the proposed collections of information are
necessary for the proper performance of the Agency's functions,
including whether the information is useful.
The accuracy of OSHA's estimate of the burden (time and
cost) of the collections of information, including the validity of the
methodology and assumptions used.
The quality, utility, and clarity of the information
collected.
Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
Please submit comments related to the Paperwork Act analysis to
OSHA in the PRA docket (Docket Number OSHA-2021-0008). Comments related
to other parts of the ETS should be submitted to the rulemaking docket
(Docket Number OSHA-2021-0007). OSHA will accept comments for 60 days
on the information collection aspects of the rule. For instructions on
submitting these comments to the rulemaking and/or PRA docket, see the
sections of this Federal Register notice titled DATES and ADDRESSES.
References
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
VI. Summary and Explanation
A. Purpose
The ETS includes a sentence that states the purpose of the rule.
The first part of the sentence in the paragraph indicates that the
standard addresses the grave danger of COVID-19 in the workplace by
establishing workplace vaccination, vaccination verification, face
covering and testing requirements.
The second part of the sentence addresses the preemption of State
and local laws, regulations, executive orders, and other requirements,
by this Federal standard. It indicates OSHA's intention that the ETS
address comprehensively the occupational safety and health issues of
vaccination, wearing face coverings, and testing for COVID-19, and thus
that the standard is intended to preempt States, and political
subdivisions of States, from adopting and enforcing workplace
requirements relating to these issues, except under the authority of a
Federally-approved State Plan. In particular, OSHA intends to preempt
any State or local requirements that ban or limit an employer's
authority to require vaccination, face covering, or testing.
Preemption of such State and local requirements derives from
section 18 of OSH Act and general principles of conflict preemption.
See Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88
(1992).\80\ Gade clarified two important principles. First, section 18
expresses Congress' intent to preempt State workplace safety or health
laws relating to issues on which Federal OSHA has promulgated
occupational safety and health standards. Under section 18, a State can
avoid preemption of such laws only if it submits and receives Federal
approval for a State Plan for the development and enforcement of
standards. OSHA-approved State Plans operate under authority of State
law and must adopt occupational safety and health standards which,
among other things, must be at least as effective in providing safe and
healthful employment and places of employment as Federal standards. 29
U.S.C. 667.
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\80\ The Court held that the dual impact licensing statutes were
preempted; however, no rationale commanded a majority. A four-
justice plurality found that supplementary State regulation is
impliedly preempted. Id. at 98-99. Justice Kennedy's concurrence
would have found express preemption rather than implied preemption,
Id. at 110-111, but otherwise agreed that ``in the OSH statute
Congress intended to pre-empt supplementary state regulation.'' Id.
at 113.
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Second, State and local laws that do not constitute occupational
safety or health laws because they are ``laws of general
applicability'' that regulate workers and nonworkers alike are
preempted only if they conflict with the federal standard. Laws of
general applicability that are consistent with the federal standard are
not preempted. Gade, 505 U.S. at 107.
While section 18 applies to every occupational safety and health
standard that OSHA promulgates, this ETS raises particular concerns
because of the current landscape of existing State and local
requirements that may overlap with, or directly conflict with, the
requirements of this ETS. As discussed in Need for the ETS (Section
III.B. of this preamble), OSHA is adopting this ETS in response to an
unprecedented health crisis that has resulted in a global pandemic
severely impacting the health and wellbeing of people in the United
States, and globally. This ETS is issued based on OSHA's determination
that employees in the United States face a grave danger from workplace
exposures to SARS-CoV-2, that the ETS is necessary to protect those
workers, and that the measures for vaccination, vaccine verification,
face coverings, and testing that this ETS requires will help ensure
that workers covered by the ETS are protected from severe illness and
death resulting from contracting COVID-19 in the workplace.
As explained in Need for the ETS (Section III.B. of this preamble),
the lack of a national standard on this hazard has led to disparate
State and local requirements, and this underscores the need for OSHA's
ETS to provide clear and consistent protection to employees across the
country. Over the past months, an increasing number of States have
passed laws or enacted other requirements banning workplace vaccination
policies that would mandate vaccination or require proof of vaccination
status, thus prohibiting employers operating in those jurisdictions
from implementing this proven method of protecting workers from the
hazard of COVID-19 that is at the core of this ETS (see, e.g., Texas
Executive Order GA-40, October 11, 2021; Montana H.B. 702, July 1,
2021; Arkansas S.B. 739, October 4, 2021 and Arkansas H.B. 1977,
October 1, 2021; AZ Executive Order 2021-18, Aug. 16, 2021). While some
States' bans have focused on preventing local governments from
requiring their public employees to be vaccinated or show proof of
vaccination, the Texas, Montana, and Arkansas requirements apply to
private employers as well. Likewise, some States and localities
have enacted requirements that prohibit businesses, government offices,
schools or other public spaces from requiring that face coverings be
worn (see, e.g., Florida Executive Order 21-102, May 3, 2021; Texas
Executive Order GA-34, March 2, 2021; Texas Executive Order GA-36, May
18, 2021). State and local requirements that prohibit employers from
implementing employee vaccination mandates, or from requiring face
coverings in workplaces, serve as a barrier to OSHA's implementation of
this ETS, and to the protection of America's workforce from this deadly
virus.
As discussed below, state restrictions of this kind are clearly
preempted whether they take the form of direct workplace regulation or
are part of a law of general applicability because they relate to the
issues addressed by this standard and conflict with it. Gade, 505 U.S.
at 99, 107. As is also discussed below, this is true even for State or
local requirements that may not prevent employers from compliance with
the ETS, but that prescribe or limit the employer's ability to mandate
vaccination for its workforce as the employer's chosen means of
compliance. See Gade, 505 at 107; see also Geier v. American Honda, 529
U.S. 861, 869, 875-886 (2000) (finding Department of Transportation
(DOT) regulations preempted a State tort action where the state action
``upset the careful regulatory scheme established by federal law'' and
placing weight on DOT's interpretation that such tort suit would be
``an obstacle to the accomplishment and execution'' of Agency
objectives). An employer's choice to mandate vaccination is a critical
aspect of this ETS, and state laws that remove that choice conflict
with it.
Thus, to ensure that the ETS supplants the existing State and local
vaccination bans and other requirements that could undercut its
effectiveness, and to foreclose the possibility of future bans, OSHA
has clearly defined the issues addressed by this section to encompass
vaccination, face covering, and testing needed to protect against
transmission of COVID-19 to employees in the workplace. To avoid
ambiguity, OSHA has stated expressly that it intends this ETS to
preempt all State and local workplace requirements that ``relate'' to
these issues, except pursuant to a State Plan. 29 U.S.C. 667(b).
The ``unavoidable implication'' of section 18 is that because OSHA
has adopted this ETS, States may no longer regulate these issues except
with OSHA's approval and the authority of a Federally-approved State
Plan. Gade, 505 U.S. at 99. As the Court explained, section 18 preempts
States without approved plans from adopting or enforcing any laws that
constitute, ``in a direct, clear and substantial way regulation of
worker health and safety'' relating to an issue addressed by an OSHA
standard. Id. at 107.
State and local requirements that ban or otherwise limit workplace
vaccination, face covering, or testing clearly ``relate'' to the
occupational safety and health ``issues'' that OSHA is regulating in
this ETS. 29 U.S.C. 667(b). Such bans regulate key workplace COVID-19
protections that are encompassed by this ETS ``in a direct, clear and
substantial way.'' Gade, 505 U.S. at 107. The direct effect of such
bans is to prohibit employers from requiring employees to implement
measures, such as vaccination requirements, face coverings, or testing.
These workplace protective measures are covered by, and, in many
circumstances required by, this ETS. For example, vaccination mandate
bans directed at employers specifically bar them from requiring
employee vaccination requirements for the purposes of protecting their
workforce. Prohibitions on face covering mandates likewise directly
prohibit individuals in positions of authority, including employers,
from requiring face covering use.
Although the expressly stated purposes for State and local
requirements banning or limiting employers from requiring vaccinations,
face coverings, or testing may not be occupational safety and
health,\81\ this does not control their preemption under section 18 of
the OSH Act. In assessing State and local requirements' impact on a
federal statutory scheme, courts ``have refused to rely solely on the
legislature's professed purpose and have looked as well to the effects
of the law.'' Gade, 505 U.S. at 105; see also, e.g., Perez v. Campbell,
402 U. S. 637, 651-652 (1971) (``[A]ny state legislation which
frustrates the full effectiveness of federal law is rendered invalid by
the Supremacy Clause''); Napier v. Atlantic Coast Line R. Co., 272 U.S.
605, 612 (1926) (pre-emption analysis does not depend on whether
federal and State laws ``are aimed at distinct and different evils''
but whether they ``operate upon the same object'').
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\81\ The express purposes of such requirements banning or
limiting employers from requiring vaccination, face coverings, or
testing may often not relate to occupational safety and health. For
example, Governor Greg Abbott's Texas face covering mandate ban in
Executive Order GA-16, is based on alleged decreasing COVID-19 rates
and the need to alleviate ``confusion,'' (Texas Executive Order GA-
36, May 18, 2021); the stated purpose of Montana's vaccination
mandate ban is to address health care privacy interests (Montana
H.B. 702, July 1, 2021).
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That a State has articulated a purpose other than, or in addition
to, workplace health and safety would not divest the OSH Act of its
preemptive force, because preemption law looks to the effects as well
as the purpose of a State law, and thus a dual-impact State law cannot
avoid OSH Act preemption simply because the regulation serves several
objectives. Gade, 505 U.S. at 107 (holding ``a law directed at
workplace safety is not saved from pre-emption simply because the State
can demonstrate some additional effect outside of the workplace'' and
``[t]hat such law may also have a nonoccupational impact does not
render it any less of an occupational standard for purposes of pre-
emption analysis''). Thus, to the extent that the stated purpose of a
requirement that bans or limits employers from requiring vaccinations,
face coverings, or testing is something other than, or in addition to,
occupational health, such laws, which have a specific and direct impact
on worker health, are nevertheless preempted.
Further, section 18 preempts even ``nonconflicting'' State and
local occupational safety and health requirements relating to the
issues addressed by this standard. Gade, 505 U.S. at 98-99, 103; see
id. at 100 (``state laws regulating the same issue as federal laws are
not saved, even if they merely supplement the federal standard''). This
is because OSHA ``'pre-empts the field' for any nonapproved State law
regulating the same safety and health issue.'' See Gade, 505 U.S. at
104, n. 2, citing English v. General Electric. Co., 496 U.S. 72, 79-80,
n.5 (``[F]ield preemption may be understood as a species of conflict
pre-emption: A State law that falls within a pre-empted field conflicts
with Congress' intent (either express or plainly implied) to exclude
state regulation''); see also id. at 105 (discussing effect of field
preemption). See generally Geier, 529 U.S. at 869, 875-886 (finding
State law preemption where it ``upset the careful regulatory scheme
established by federal law''); Williamson v. Mazda Motor of Am., Inc.,
562 U.S. 323, 330-36 (2011) (affirming the conflict pre-emption
principle that ``a state law that stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of a
federal law is pre-empted'' and finding preemption where State law
interfered with ``significant objective'' of the federal regulation).
For example, the ETS would preempt State or local governments from
dictating that employers adopt a scheme of testing and face coverings
that complies with 1910.501(g) and (i) of the ETS, but that bars
employers from electing the preferred vaccine mandate alternative in
paragraph (d), because this interferes with OSHA's significant
regulatory objectives and its preemption of the field.\82\ (See Need
for the ETS (Section III.B. of this preamble) discussing that
vaccination is the preferred compliance option under this rule because
it is the most effective method of protecting workers from COVID-19).
Likewise, the ETS would preempt such State or local occupational
requirements, even to the extent that they may regulate employers with
fewer than 100 employees, notwithstanding that the requirements in this
ETS only apply to employers with more than 100 employees.
---------------------------------------------------------------------------
\82\ OSHA is aware that some States have adopted or are
considering adopting such requirements, which this ETS would preempt
(see, e.g., Arkansas S.B. 739, October 4, 2021 and Arkansas H.B.
1977, October 1, 2021, which Arkansas Governor Asa Hutchinson
allowed to became law without his signature, and which require
employers in Arkansas to allow employees to opt out of vaccination
for purposes of complying with federal vaccination requirements; see
also Governor Hutchinson, October 13, 2021; Marr, October 7, 2021
(describing the Arkansas legislation and noting that other states
may contemplate similar legislation)).
---------------------------------------------------------------------------
Case law is instructive on this point. In Gade, the Supreme Court
found regulations implementing a State statute that required training
for workers handling hazardous waste that went beyond, but did not
conflict with, OSHA's hazardous waste training requirements to be
preempted by the OSHA requirements. Id. Likewise, in Industrial Truck
Association Incorporated v. Henry, the Ninth Circuit found that OSHA's
hazard communication standard preempted California's Hazard
Communication regulations that were not submitted to OSHA for approval
through its State Plan, even to the extent that California's Hazard
Communication rule regulated manufacturers and distributers who were
excluded from coverage under federal OSHA's rule. Indust. Truck Ass'n
v. Henry, 125 F.3d 1305, 1311-14 (9th Cir. 1997). In the same way, the
ETS preempts all State and local requirements that bar or limit the
ability of an employer to require workplace vaccination, testing, and
face coverings to protected employees against COVID-19 in any respect,
since OSHA has occupied the entire field of regulation on these issues.
OSHA's definition of the ``issue'' in this rule should be afforded
weight, since the OSH Act vests OSHA with standard-setting
responsibility and, therefore, the authority to determine which
``issues'' to address with occupational safety and health standards.
See Indust. Truck, 125 F.3d at 1311 (relying on OSHA's regulation and
statements in the preamble to identify the relevant ``issue'' for
preemption purposes in OSHA's Hazard Communication standard).
Importantly, although OSHA's stated intention is to preempt
conflicting State and local requirements relating to the issues
addressed by this standard, OSHA recognizes that the OSH Act does not
allow, and OSHA does not intend, for the ETS to preempt non-conflicting
State or local requirements of general applicability. In Gade, the
Supreme Court qualified its ruling by saving from preemption non-
conflicting State and local ``laws of general applicability (such as
laws regarding traffic safety or fire safety) that do not conflict with
OSHA standards and that regulate the conduct of workers and nonworkers
alike.'' Gade, 505 U.S. at 107. The Majority reasoned that,
``[a]lthough some laws of general applicability may have a `direct and
substantial' effect on worker safety, they cannot fairly be
characterized as `occupational' standards, because they regulate
workers simply as members of the general public.'' Id.
During the pandemic, many States and municipal governments have
adopted requirements intended to protect public health by helping to
prevent the spread of COVID-19 in public spaces. These have included
requirements mandating face coverings in indoor public spaces,
including businesses, government buildings, and schools (see, e.g.,
Baltimore City Health Department, August 10, 2021; Illinois Executive
Order 2021-20, August 26, 2021; Hawai'i Emergency Proclamation, October
1, 2021). In addition, in recent months, some States and municipal
governments have adopted requirements mandating that members of the
public provide proof of vaccination or recent COVID-19 testing in order
to enter restaurants, bars, or other businesses or public spaces (see,
e.g., NYC Emergency Executive Order 225, August 16, 2021 (mandating
COVID-19 vaccination for most individuals for indoor entertainment,
recreation, dining and fitness settings)). Requirements such as these
apply to ``workers and nonworkers alike'' and ``regulate workers simply
as member of the general public'' and are accordingly not preempted.
Gade, 505 U.S.at 107.
Based on OSHA's observations and experience during the past year
and a half that the pandemic has been ongoing, OSHA is confident that
protective State and local regulations of general applicability that
mandate face coverings or vaccination will complement, rather than
interfere with OSHA's enforcement of the ETS, and also does not intend
to preempt such requirements. Indeed, OSHA believes that such measures
have significantly reduced the harmful effects of the pandemic and
total fatalities. See Steel Institute of NY v. The City of NY, 716 F.3d
31, 38 (affording some weight to OSHA's view that municipal regulations
governing construction cranes did not interfere with OSHA's regulatory
scheme in its crane standards and ultimately adopted OSHA's view in
finding these municipal regulations were not preempted by OSHA crane
standards).\83\
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\83\ OSHA's Cranes and Derricks in Construction rule directly
discussed its expectations and intent regarding the preemptive
effect of the rule, including that it was not intended to preempt
generally applicable municipal regulations, such as building codes,
which serve public safety purposes. Cranes and Derricks in
Construction, 75 FR 47,906, 48,128 (August 9, 2010). This rule also
includes a provision that requires employers to comply with State
crane operator licensing requirements that meet the federal floor
for crane operator certification in the rule. 29 CFR
1926.1427(c)(1). OSHA has also indicated that its rule would not
preempt State or local requirements in other rulemakings. See e.g.,
72 FR 7136, 7188 (Feb. 14, 2007) (Preamble to OSHA's most recent
electrical safety standard) (``State and local fire and building
codes, which are designed to protect a larger group of persons than
employees,'' are not preempted); 29 CFR 1910.134(e) (requiring
compliance with State and local laws by requiring ``a licensed
health care professional'' to perform a medical evaluation of an
employee's ability to use a respirator).
---------------------------------------------------------------------------
In Steel Institute, the Second Circuit held that OSHA's crane
regulations did not preempt New York City municipal regulations
governing construction cranes, finding that such regulations were
requirements of general applicability, notwithstanding their direct
bearing on worker safety, because their primary purpose and effect was
to preserve the safety of the general public, and they regulated
workers and nonworkers alike. Id. The Steel Institute court noted the
``strong presumption against preemption when states and localities
``exercise[ ] their police powers to protect the health and safety of
their citizens.'' Id. at 36, citing Medtronic, Inc. v. Lohr, 518 U.S.
470, 475 (1996). The Second Circuit was also influenced by the clear
danger presented to the public by unsafe crane operation. This is
analogous to the situation here, because exposure to COVID-19 is a
hazard that directly impacts everyone. Thus, generally applicable State
and local mandates requiring face coverings or vaccination should not
be preempted and should
remain in effect, notwithstanding this ETS.\84\
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\84\ In addition, some State and local governments have adopted
vaccination mandates directed at State and/or local government
employees. The OSH Act and OSHA's standards would not preempt such
requirements since State or local government employers and employees
are exempt from OSHA coverage under the OSH Act. 29 U.S.C. 652 (5)
(defining employer to exclude ``any State or political subdivision
of a State''). However, many State and local government employers in
States with OSHA-approved State Plans will be covered by State
occupational safety and health requirements, and State Plans must
adopt requirements for State and local government employers, as well
as covered private sector employers, that are at least as effective
as federal OSHA's requirements; State Plans may also choose to adopt
more protective occupational safety and health requirements. 29
U.S.C. 667(c).
---------------------------------------------------------------------------
On the other hand, as noted above, this standard will preempt
requirements that conflict with it, regardless of whether the
requirements are part of a law of general applicability.\85\
---------------------------------------------------------------------------
\85\ As previously discussed, bans on mandating vaccinations or
face coverings have not typically been generally applicable, but
even the least workplace-specific, most generally applied bans will
not survive preemption because they directly interfere with the
ETS's regulatory scheme.
---------------------------------------------------------------------------
The effect of the ETS on State law requirements in State Plan
States works somewhat differently. As previously noted, under section
18 of the OSH Act States that wish to assume responsibility for the
development and enforcement of ``occupational safety and health
standards relating to any occupational safety or health issue with
respect to which a Federal standard has been promulgated'' may submit a
State Plan to OSHA for approval. Id. section 667(b); see also id.
section 667(c) (describing requirements for OSHA approval of State
Plans on issues for which OSHA has adopted standards). There are 22
States and territories that have OSHA-approved State Plans for private
employers, and 6 additional States and territories that have OSHA-
approved State Plans for public employers only.
Under section 18(c)(2) of the OSH Act, State Plans are required to
adopt and enforce occupational safety and health standards that are at
least as effective as federal OSHA's requirements. Id. section
667(c)(2). In addition, the OSH Act requires that State Plans must
cover State and local government employees (including, e.g., State and
local school systems within the scope of this rule), even though
federal OSHA does not have coverage over such employees in States
without OSHA-approved State Plans.
Once OSHA promulgates an ETS, OSHA's regulations provide that those
States have ``30 days after the date of promulgation of the Federal
standard to adopt a State emergency temporary standard,'' or to
demonstrate ``that promulgation of an emergency temporary standard is
not necessary because the State standard is already the same or at
least as effective as the Federal standard change.'' 29 CFR
1953.5(b)(1). The new ETS becomes part of the OSHA-approved State Plan
through the State Plan's submission to OSHA documentation showing it
adopted an identical ETS or a ``Plan Change Supplement'' showing that
it has adopted requirements that are ``at least as effective'' as
federal OSHA's ETS. 29 CFR 1953.5(b)(3); 1953.4.
Even in States with OSHA-approved State Plans, any State law
relating to an occupational safety and health issue that OSHA regulates
is preempted unless it is submitted for OSHA's approval as a supplement
to the State Plan. Indust. Truck Ass'n, 125 F.3d at 1311 (``If a State
wishes to regulate an issue of worker safety for which a federal
standard is in effect, its only option is to obtain the prior approval
of the Secretary of Labor . . . [and] [i]t would make the state plan
approval requirement superfluous if a state could pick and choose which
occupational health and safety regulations to submit to OSHA''). Thus,
a State or local requirement banning or limiting employer vaccine
mandates would similarly be preempted because it has not been approved
by federal OSHA as part of the State Plan. And, indeed, it could not be
approved by federal OSHA, because such bans or limitations undercut the
ETS's requirements and are clearly not as effective as the federal ETS.
See 29 U.S.C. 667(c)(2).\86\
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\86\ For example, Arizona has an OSHA-approved State Plan, but
its vaccination ban, which is not part of its State Plan, is
preempted by this ETS (see AZ Executive Order 2021-18, Aug. 16,
2021).
---------------------------------------------------------------------------
Finally, this provision includes a note that this section
establishes minimum requirements for employers, that nothing in this
section prevents employers from agreeing with their employees to
implement additional measures, and that this section does not supplant
collective bargaining agreements or other collectively negotiated
agreements in effect that may have negotiated terms that exceed the
requirements herein. It also references the National Labor Relations
Act of 1935, which protects most private-sector employees' right to
take collective action. The purpose of this note is to remind employers
and employees that OSHA's ETS establishes a floor for protections, and
that it does not preclude bargaining for additional protective
measures. For example, employers might agree to cover the costs of face
coverings or medical removal, or to a requirement that all employees,
regardless of vaccination status, wear face coverings while working
indoors.
References
An Act Prohibiting Discrimination Based on a Person's Vaccination
Status or Possession of an Immunity Passport; Montana H.B. 702.
(2021, July 1). https://leg.mt.gov/bills/2021/billpdf/HB0702.pdf.
(Montana H.B. 702, July 1, 2021)
Arizona Executive Order 2021-18. (2021, August 16). https://azgovernor.gov/sites/default/files/eo_2021-18.pdf. (AZ Executive
Order 2021-18, August 16, 2021)
Arkansas H.B. 1977. (2021, October 1). To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); and to Declare an Emergency. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FAMEND%2F2021R%2FPublic%2FHB1977-H1.pdf.
(Arkansas H.B. 1977, October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act Concerning Employment
Issues Related to Coronavirus 2019 (COVID-19); To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); To Declare and Emergency; and For Other
Purposes. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FBills%2F2021R%2FPublic%2FSB739.pdf. (Arkansas
S.B. 739, October 4, 2021)
Arkansas Governor Asa Hutchinson. (2021, October 13). Press Release:
Governor Hutchinson Allows Vaccine Mandate, Redistricting Bills to
Become Law Without His Signature. https://governor.arkansas.gov/news-media/press-releases/governor-hutchinson-allows-vaccine-mandate-redistricting-bills-to-become-la. (Governor Hutchinson,
October 13, 2021)
Baltimore City Health Department. (2021, August 10). Health
Commissioner Updated Directive and Order for Face Coverings. https://www.baltimorecity.gov/sites/default/files/HEALTH%20COMMISSIONER%20AUGUST%2010,%202021%20DIRECTIVE%20AND%20ORDER%20FOR%20FACE%20COVERINGS_FINAL.pdf. (Baltimore City Health
Department, August 10, 2021)
Emergency Executive Order 225. (2021, August 16). Key to NYC:
Requiring COVID-19 Vaccination for Indoor Entertainment, Recreation,
Dining and Fitness Settings. https://www1.nyc.gov/office-of-the-mayor/news/225-001/emergency-executive-order-225. (NYC Emergency
Executive Order 225, August 16, 2021)
Florida Executive Order 21-102. (2021, May 3). https://
www.flgov.com/wp-content/
uploads/orders/2021/EO_21-102.pdf. (Florida Executive Order 21-102,
May 3, 2021)
Hawai'i Emergency Proclamation Related to the State's COVID-19 Delta
Response. (2021, October 1). https://governor.hawaii.gov/wp-content/uploads/2021/10/2109152-ATG_Emergency-Proclamation-Related-to-the-States-COVID-19-Delta-Response-distribution-signed.pdf. (Hawai'i
Emergency Proclamation, October 1, 2021)
Illinois Executive Order 2021-20. (2021, August 26). https://www.illinois.gov/government/executive-orders/executive-order.executive-order-number-20.2021.html. (Illinois Executive Order
2021-20, August 26, 2021)
Marr C. (2021, October 7). Workplace Vaccine Exemption Bills Sent to
Arkansas Governor. Bloomberg Law. https://news.bloomberglaw.com/daily-labor-report/workplace-vaccine-exemption-bills-sent-to-arkansas-governor. (Marr, October 7, 2021)
Texas Executive Order GA-34. (2021, March 2). Executive Order No.
GA-34 relating to the opening of Texas in response to the COVID-19
disaster. https://open.texas.gov/uploads/files/organization/opentexas/E.O.-GA-34-opening-Texas-response-to-COVID-disaster-IMAGE-03-02-2021.pdf. (Texas Executive Order GA-34, March 2, 2021)
Texas Executive Order GA-36. (2021, May 18). Executive Order No. GA-
36 relating to the prohibition of governmental entities and
officials from mandating face coverings or restricting activities in
response to the COVID-19 disaster. https://gov.texas.gov/uploads/files/press/E.O.-GA-36_prohibition_on_mandating_face_coverings_response_to_COVID-19_disaster_IMAGE_05-18-2021.pdf. (Texas Executive Order GA-36, May
18, 2021)
Texas Executive Order GA-40. (2021, October 11). Executive Order No.
GA-40 relating to prohibiting vaccine mandates, subject to
legislative action. https://gov.texas.gov/uploads/files/press/E.O.-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
B. Scope and Application
Paragraph (b)(1) of this ETS provides that the ETS applies to all
employers that have a total of at least 100 employees at any time the
ETS is in effect. OSHA has determined that the unvaccinated employees
of these employers face a grave danger of exposure to SARS-CoV-2,
including the Delta variant, while they are at work (see Grave Danger,
Section III.A. of this preamble). Because this grave danger finding
applies to all unvaccinated employees who come into contact with other
people in indoor work settings as part of their employment, this ETS is
not limited by industrial sector or NAICS code. Therefore, this
standard generally covers employers in all workplaces that are under
OSHA's authority and jurisdiction, including industries as diverse as
manufacturing, retail, delivery services, warehouses, meatpacking,
agriculture, construction, logging, maritime, and healthcare.
I. Decision To Limit Coverage of This ETS to Employers With 100 or More
Employees
This ETS applies to employers with a total of 100 or more employees
at any time the standard is in effect. In light of the unique
occupational safety and health dangers presented by COVID-19, and
against the backdrop of the uncertain economic environment of a
pandemic, OSHA established this coverage threshold for four reasons.
First, OSHA is confident that employers with 100 or more employees will
be able to meet the standard's requirements promptly, as the emergency
addressed by the standard necessitates. OSHA is less confident that
smaller employers can do so without undue disruption. Second, this
coverage threshold will enable the standard to reach two-thirds of all
private-sector workers in the nation, providing them with prompt
protection. Third, the standard will reach the largest facilities,
where the most deadly outbreaks of COVID-19 can occur. Fourth, the 100-
employee threshold in this standard is comparable with the size
thresholds established by congressional and agency decisions in
analogous contexts.
a. Challenges to Feasibility Analysis for Small Businesses
An OSHA standard, including an ETS, must be both economically and
technologically feasible. A standard is economically feasible under the
OSH Act if it neither threatens ``massive dislocation to'' nor upsets
the ``competitive stability of'' the regulated industries. United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1265 (D.C.
Cir. 1980). Technological feasibility has been interpreted broadly to
mean ``capable of being done'' Am. Textile Mfrs. Inst. v. Donovan, 452
U.S. 490, 509-510 (1981).
As shown in Economic Analysis, Section IV.B. of this preamble, OSHA
is confident that this standard is feasible for employers with 100 or
more employees. OSHA is not at this time making any determination about
whether it would be appropriate to extend the ETS to cover smaller
employers. Put simply, the agency is requiring that employers it is
confident can implement the provisions of the standard without delay do
so. At the same time, the agency is soliciting public comment and
seeking additional information to assess the ability of smaller
employers to do so in the rulemaking commenced by this ETS. OSHA will
determine the issue on the basis of the record, after receiving public
comment.\87\ The SARS-CoV-2 virus continues to spread rapidly, and each
day that passes, tens of thousands more people are infected. The
employees of larger firms should not have to wait for the protections
of this standard while OSHA takes the additional time necessary to
assess the feasibility of the standard for smaller employers.
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\87\ If OSHA receives information suggesting that a broader
scope would be appropriate, the agency could expand the scope of the
ETS quickly through a supplemental action. Fla. Peach Growers Ass'n,
Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 127 (5th Cir. 1974)
(``It is inconceivable that Congress, having granted the Secretary
the authority to react quickly in fast-breaking emergency
situations, intended to limit his ability to react to developments
subsequent to his initial response.'')
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The pandemic has presented special challenges for small businesses.
According to a survey conducted during its early stages, 66% of
businesses with fewer than 100 employees had suffered revenues losses
exceeding 30%. (SHRM, May 6, 2020a). By contrast, only 27% of larger
businesses with more than 100 employees had seen revenue drops of more
than 30% (SHRM, May 6, 2020b). More recently, 61% of the members of the
National Federation of Independent Businesses, mostly very small
businesses, responded to a survey reported that they were experiencing
staff shortages, with half of that group reporting a moderate to
significant loss of sales because of unfilled positions (NFIB, July 12,
2021).
The requirements of the ETS could have a differential impact on
small businesses compared with larger firms. Many small businesses lack
separate human resources departments and struggle to carry out HR
functions. A study found that some 70% of small businesses (with 5 to
49 employees) handle HR tasks in an ad hoc way. (ADP, December 2016).
Only 23% of ad hoc managers believed they had the tools and resources
necessary to perform HR tasks well, and only 19% were fully confident
in their ability to handle HR tasks without making mistakes (ADP,
December 2016). Another survey found that HR functions are
proportionally far more expensive for smaller firms than for larger
(small firms defined as up to 250 workers) (SHRM, 2015). The ETS
requires employers to establish new systems to track vaccination status
among workers, to keep related records, and for firms that allow the
testing option, to keep records of each test.
These records must be treated as confidential medical records subject
to detailed regulations, which is not something most smaller employers
typically need to do or have existing systems in place to address. 29
CFR 1910.1020. While OSHA has imposed similar requirements on smaller
employers before, it has typically done so in highly regulated
industries, such as healthcare, or in industries involving complicated
industrial processes, which already require a certain degree of
administrative capacity even when not responding to a grave danger,
through a rulemaking process that provides additional time for notice
and implementation, and when there is more time to assess the impact
that the standard would have on small business. This emergency standard
by contrast applies across the board to all industries, including less
regulated retail and service sectors.
Moreover, OSHA estimates that some 5% of employees may have a
medical contraindication or request an accommodation from the rule's
requirements for disability or sincerely held religious belief reasons.
(Please see Economic Analysis, Section IV.B. of this preamble).
Assessing these requests may require more resources for smaller firms
with less experience in this area, particularly if they lack HR staff.
By the same token, a delay in applying the ETS to businesses with fewer
than 100 employees would allow those businesses the benefit of learning
from the models established by larger businesses with respect to
accommodations. Similarly, implementing the ETS's testing provisions in
a stepwise fashion will allow OSHA the time necessary to assess any
impact the new requirements may have on the testing infrastructure and
related supply chains before considering extending those requirements
to additional employers.
b. The ETS Provides Prompt Protection for Most of America's Workforce
The 100 employee threshold means the ETS will reach two-thirds of
the nation's private sector workforce, providing protection to millions
of workers while issues regarding smaller firms are reviewed. OSHA
considered that a 100 employee threshold was superior to a 150 employee
threshold in this respect, because it would protect more employees: 67%
rather than 63%, which is a difference of 4.856 million workers. (U.S.
Census Bureau, May 2021). And while a 50 employee threshold would have
covered more employees (78%), it would have required additional
feasibility analysis, while still leaving many employees outside the
standard. (U.S. Census Bureau, May 2021).
c. The ETS Will Help Prevent Large Outbreaks of COVID-19
The ETS's focus on employers with more than 100 employees will also
help prevent large-scale outbreaks. As addressed in more detail in the
discussion of Grave Danger (Section III.A. of this preamble), all
unvaccinated employees who work in indoor settings face a grave danger
from COVID-19, which is why the scope of the ETS is not limited to
worksites of a specific size. The standard is based on employer size
primarily because administrative capacity is more closely related to
employer size. In addition, employer size provides a clear measure that
is easy for employers (and OSHA) to track, as opposed to an alternative
such as a workplace-based approach, which could fluctuate from day to
day and mean more places and information for the employer to track. But
OSHA also chose the 100 employee size threshold in recognition of the
fact that larger employers are more likely to have many employees
gathered in the same location. For employers with 100 or more
employees, the median number of employees at any one location is
approximately 50 (the average is also 50). (U.S. Census Bureau, May
2021). For employers with fewer than 100 employees, the median number
of any one location is approximately 2 (with an average number of 7)
(U.S. Census Bureau, May 2021).
Employees at larger locations are statistically more likely to be
exposed to someone with COVID-19 during the course of their shifts, and
thus face a heightened risk of virus transmission. Studies indicate
that introduction of infection and the risk of infection transmission
is increased with the size of a gathering (Champredon et al., April,
2021), and with larger populations (Shacham et al., July 5, 2021). See
also (Contreras et al., July, 2021) (concluding that outbreaks were
larger and lasted longer at facilities with more onsite staff). It is
therefore not surprising that significant COVID-19 outbreaks have
occurred at large facilities of employers with 100 or more employees
\88\ (Oregon Health Authority, October 6, 2021; CDPHE, October 6,
2021). A study of outbreaks in Los Angeles County found that the median
number of employees in an establishment in which an outbreak occurred
was 95, well above the 50 employee median for locations of employers
covered by this rule, indicating that the rule will protect employees
in the places where outbreaks are most likely to occur. (Contreras et
al., July, 2021). And those outbreaks occurred even before the
emergence of the SARS-CoV-2 Delta variant, which the CDC says ``causes
more infections and spreads faster than early forms of SARS-CoV-2.''
(CDC, August 26, 2021) In fact, the studies noted earlier in this
paragraph were published just as the Delta variant was emerging,
meaning that the risk of transmission cited in those studies has likely
increased.
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\88\ See, e.g., Oregon Health Authority, October 6, 2021,
(publishing data on outbreaks in large workplaces including two
Amazon facilities, several hospitals, and a Walmart distribution
center); CDPHE, Oct. 6, 2021, (identifying an active Covid outbreak
in Cargill's Fort Morgan, CO meat processing plant, which employs
more than 2,000 workers). While some have speculated that clusters
of infections among employees at the same facility might result
initially from shared exposures outside of work, the original source
of the infection would have little bearing on the statistical
probability of exposure and transmission once the infected people
are together in the workplace with unvaccinated co-workers. The most
effective way to prevent further transmission is to protect the
other workers through vaccination or, when that is not possible,
identify and remove the infected workers from the workplace as
quickly as possible.
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While virus transmission is certainly not limited to large
facilities, the potential scope of an outbreak is inherently more
limited when fewer employees are present. In limiting the scope of the
ETS to employers with 100 or more employees, OSHA is prioritizing
coverage of those businesses in which the spread of the virus could
potentially affect the largest number of employees and for which the
agency is most confident that it is feasible to apply the standard.
d. Analogous Regulatory Regimes Use Comparable Employee Size Thresholds
Congress and federal agencies have frequently recognized that an
employee size threshold may be appropriate in different regulatory
contexts. They have not settled on any one number as the most
appropriate, presumably because that depends on balancing different
considerations that are relevant to the particular context, as OSHA has
done here. But several analogous regulatory regimes use employee size
thresholds comparable to the one selected here, in light of similar
concerns about administrative feasibility.
For example, the EEOC has issued regulations requiring employers
with 100 or more employees to submit annual reports related to equal
employment opportunity in their workforce, in recognition that larger
employers are better equipped to absorb the types of administrative
burdens
imposed by surveying, tracking and recordkeeping requirements. See 42
U.S.C. 2000e-8(c), 29 CFR 1602.7-.14 and 41 CFR 60-1.7(a). In earlier
measures adopted in response to the COVID-19 pandemic, Congress adopted
special protections and exemptions based on employee counts. The
Families First Coronavirus Response Act, Public Law 116-127 (2020),
sections 7001 and 7003 provided tax credits to businesses with fewer
than 500 employees to assist compliance with the Act's expansion of
paid sick and family leave, in recognition of the challenges facing
smaller employers. Congress again relied on the same 500 employee
threshold when it later extended tax credits only to employers who
granted employees paid time off to be vaccinated, implicitly
acknowledging the financial obstacles that can exist for smaller
employers for the same activity that this ETS promotes (and without the
vaccine policy and verification requirement in this ETS). American
Rescue Plan Act, Public Law 117-2, Sec. 9641 (2021).
In the Affordable Care Act, Congress set the maximum size of a
``small employer'' at 100 employees for purposes of allowing greater
flexibility to these employers. 42 U.S.C.A. 18024(b)(3). Likewise,
private employers with fewer than 50 employees are exempt from
complying with the Family and Medical Leave Act, in recognition of
smaller employers' decreased administrative capacity, as well as their
inability to easily accommodate employee absences. 29 U.S.C.A.
2611(2)(b)(2).
e. The 100 Employee Coverage Provision Is a Reasonable Exercise of the
Secretary's Authority
OSHA's choice of a 100 employee threshold is based on balancing the
fundamentally incommensurable considerations described above. Under the
statute OSHA ``shall'' issue an ETS when employees are exposed to grave
danger, and is not to follow normal notice and comment procedures to
build a record. 29 U.S.C. 655(e). But OSHA may not issue an ETS unless
it shows that the rule is feasible for the employers covered, and it
has not yet made a feasibility determination for smaller employers. In
the circumstances of this case, OSHA considered that an ETS was
urgently needed to protect employees, that a 100 employee threshold
would protect the great majority of them and prevent the largest
outbreaks, that it would avoid the delays that would be needed if the
agency were required to gather information and analyze feasibility for
smaller employers, and that a comparable size threshold has been found
appropriate in similar contexts. Where employees are dying every day,
it is not unreasonable for the agency to prioritize doing what it can
to address the problem quickly, regardless of whether there are further
actions it might be able to take later.
Doing so implements the statutory delegation of authority to the
agency to establish priorities for issuing standards by giving ``due
regard to the urgency of the need'' for standards for particular
workplaces. 29 U.S.C. 655(g). The courts have recognized that this
provision authorizes the Secretary to make reasonable decisions
limiting the scope of a standard, particularly where as here the agency
has said it will address the reserved issue in subsequent rulemaking.
Forging Indus. Assoc. v. Donovan, 773 F.2d 1436, 1454 (4th Cir. 1985)
(hearing conservation standard); United Steelworkers of Am. v.
Marshall, 647 F.2d 1189, 1309-1310 (D.C. Cir. 1980) (lead standard).
Where competing considerations are in play and there is no clear
perfect choice, OSHA has a degree of discretion to draw a reasonable
line. Courts have consistently recognized that agencies have discretion
to draw reasonable lines. As the D.C. Circuit has explained: An agency
has ``wide discretion'' in making line-drawing decisions and ``[t]he
relevant question is whether the agency's numbers are within a zone of
reasonableness, not whether its numbers are precisely right.''
WorldCom, Inc. v. FCC, 238 F.3d 449, 462 (D.C. Cir. 2001) (quotation
marks omitted). An agency ``is not required to identify the optimal
threshold with pinpoint precision. It is only required to identify the
standard and explain its relationship to the underlying regulatory
concerns.'' Id. at 461-62. Nat'l Shooting Sports Found. v. Jones, 716
F.3d. 200, 214-215 (D.C. Cir 2013). See also Providence Yakima Med.
Ctr. v. Sebelius, 611 F.3d 1181, 1190-1191 (9th Cir. 2010).
For the reasons discussed above, the balance the agency struck here
falls well within this zone of reasonableness.
II. Explanation of Who Is Included in the 100-Employee Threshold
The applicability of this ETS is based on the size of an employer,
in terms of number of employees, rather than on the type or number of
workplaces. In determining the number of employees, employers must
include all employees across all of their U.S. locations, regardless of
employees' vaccination status or where they perform their work. Part-
time employees do count towards the company total, but independent
contractors do not. As discussed above, OSHA has not found that the
standard is feasible for firms with fewer than 100 employees, because
it needs additional time to assess the impact of the standard on these
employers, particularly as many smaller firms lack separate human
resources departments and may face additional challenges when carrying
out human resources functions. In contrast, OSHA has determined that
the standard is feasible for firms with 100 or more employees,
regardless of where those employees report to work. These firms
generally have greater administrative capacities, and including all
such employers in the scope of this ETS ensures that OSHA can cover
two-thirds of all workers in the private sector as quickly as possible.
For a single corporate entity with multiple locations, all
employees at all locations are counted for purposes of the 100-employee
threshold for coverage under this ETS. In a traditional franchisor-
franchisee relationship in which each franchise location is
independently owned and operated, the franchisor and franchisees would
be separate entities for coverage purposes, such that the franchisor
would only count ``corporate'' employees, and each franchisee would
only count employees of that individual franchise. In other situations,
two or more related entities may be regarded as a single employer for
OSH Act purposes if they handle safety matters as one company, in which
case the employees of all entities making up the integrated single
employer must be counted.
In scenarios in which employees of a staffing agency are placed at
a host employer location, only the staffing agency would count these
jointly employed workers for purposes of the 100-employee threshold for
coverage under this ETS. Although the staffing agency and the host
employer would normally share responsibility for these workers under
the OSH Act, this ETS raises unique concerns in that OSHA has set the
threshold for coverage based primarily on administrative capacity for
purposes of protecting workers as quickly as possible, as discussed
above, and the staffing agency would typically handle administrative
matters for these workers. Thus, for purposes of the 100-employee
threshold, only the staffing agency would count the jointly employed
employees. The host employer, however, would still be covered by this
ETS if it has 100 or more employees in addition to the employees of the
staffing agency. For enforcement purposes, traditional joint employer
principles would apply where both employers are covered by the ETS, as
illustrated further by the examples below. See also https://www.osha.gov/temporaryworkers/.
On a typical multi-employer worksite such as a construction site,
each company represented--the host employer, the general contractor,
and each subcontractor--would only need to count its own employees, and
the host employer and general contractor would not need to count the
total number of workers at each site. That said, each employer must
count the total number of workers it employs regardless of where they
report for work on a particular day. Thus, for example, if a general
contractor has more than 100 employees spread out over multiple
construction sites, that employer is covered under this ETS even if it
does not have 100 or more employees present at any one worksite.
Covering the employees of larger employers at multi-employer worksites
would mitigate the spread of COVID-19 at the workplace even where not
all employees are covered by this ETS because fully vaccinated
employees (or unvaccinated employees wearing face coverings and
submitting to weekly testing) would be less likely to spread the virus
to unvaccinated workers at the site who are not covered by this ETS.
The determination as to whether a particular employer is covered by
the standard should be made separately from whether individual
employees are covered by the standard's requirements, as described by
paragraph (b)(3) (e.g., some employers may be covered but have no
duties with respect to some of their employees under this standard).
Some additional examples include:
If an employer has 75 part-time employees and 25 full-time
employees, the employer would be within the scope of this ETS because
it has 100 employees.
If an employer has 150 employees, 100 of whom work from
their homes full-time and 50 of whom work in the office at least part
of the time, the employer would be within the scope of this ETS because
it has more than 100 employees.
If an employer has 102 employees and only 3 ever report to
an office location, that employer would be covered.
If an employer has 150 employees, and 100 of them perform
maintenance work in customers' homes, primarily working from their
company vehicles (i.e., mobile workplaces), and rarely or never report
to the main office, that employer would also fall within the scope.
If an employer has 200 employees, all of whom are
vaccinated, that employer would be covered.
If an employer has 125 employees, and 115 of them work
exclusively outdoors, that employer would be covered.
If a single corporation has 50 small locations (e.g.,
kiosks, concession stands) with at least 100 total employees in its
combined locations, that employer would be covered even if some of the
locations have no more than one or two employees assigned to work
there.
If a host employer has 80 permanent employees and 30
temporary employees supplied by a staffing agency, the host employer
would not count the staffing agency employees for coverage purposes and
therefore would not be covered. (So long as the staffing agency has at
least 100 employees, however, the staffing agency would be responsible
for ensuring compliance with the ETS for the jointly employed workers.)
If a host employer has 110 permanent employees and 10
temporary employees from a small staffing agency (with fewer than 100
employees of its own), the host employer is covered under this ETS and
the staffing agency is not.
If a host employer has 110 permanent employees and 10
employees from a large staffing agency (with more than 100 employees of
its own), both the host employer and the staffing agency are covered
under this standard, and traditional joint employer principles apply.
Generally, in a traditional franchisor-franchisee
relationship, if the franchisor has more than 100 employees but each
individual franchisee has fewer than 100 employees, the franchisor
would be covered by this ETS but the individual franchises would not be
covered.
As explained earlier, part of OSHA's rationale in adopting the 100-
employee threshold is to focus the ETS on companies that OSHA is
confident will have sufficient administrative systems in place to
comply quickly with the ETS. Thus, the ETS applies to all employers who
have the requisite number of employees at any time this ETS is in
effect. Along with employers that always have more than 100 employees,
OSHA intends to cover employers that fluctuate above and below the 100-
employee threshold during the term of the ETS because those employers
will typically have already developed systems and capabilities for
compliance; a decrease in the number of employees is therefore unlikely
to make them less capable of compliance.
The determination of whether an employer falls within the scope of
this ETS based on number of employees should initially be made as of
the effective date of the standard, as set out in paragraph (m)(1). If
the employer has 100 or more employees on the effective date, this ETS
applies for the duration of the standard. If the employer has fewer
than 100 employees on the effective date of the standard, the standard
would not apply to that employer as of the effective date. However, if
that same employer subsequently hires more workers and hits the 100-
employee threshold for coverage, the employer would then be expected to
come into compliance with the standard's requirements. Once an employer
has come within the scope of the ETS, the standard continues to apply
for the remainder of the time the standard is in effect, regardless of
fluctuations in the size of the employer's workforce. For example, an
employer that has 103 employees on the effective date of the standard,
but then loses four within the next month, would continue to be covered
by the ETS. OSHA is confident that employers with 100 or more employees
at any point while this ETS is in effect have the administrative
capacity to comply with the ETS, even if the number of employees
fluctuates somewhat above and below 100.
Paragraph (b)(2) of this ETS sets forth two exemptions to the
standard.\89\ Under paragraph (b)(2)(i), this ETS does not apply to
workplaces covered by the Safer Federal Workforce Task Force COVID-19
Workplace Safety: Guidance for Federal Contractors and Subcontractors
(see Safer Federal Workforce Task Force, September 24, 2021). With
limited exceptions, such as where a medical contraindication,
disability, or sincerely held religious belief would prevent an
employee from complying with certain provisions, those guidelines
require covered
contractors to ensure that all covered contractor employees (1) are
fully vaccinated by December 8, 2021; (2) follow CDC guidelines for
masks and physical distancing, including masking and distancing
requirements based on the employee's vaccination status and the level
of community transmission of COVID-19 where the workplace is located;
and (3) designate a person to coordinate COVID-19 workplace safety
efforts at covered workplaces. Because covered contractor employees are
already covered by the protections in those guidelines, OSHA has
determined that complying with this standard in addition to the federal
contractor guidelines is not necessary to protect covered contractor
employees from a grave danger posed by COVID-19. Although there may be
some respects in which the OSHA standard is somewhat more protective,
such as providing paid leave for vaccination, the federal contractor
guidelines are somewhat more protective in other respects, such as
requiring vaccination for everyone who does not have a right to an
accommodation rather than allowing employees to submit to testing in
lieu of vaccination. In essence, they are similar but slightly
different schemes that provide roughly equivalent protection, and OSHA
has determined that imposing a second set of similar protections on
covered federal contractors by subjecting them to this ETS in addition
to the federal contractor guidance is not necessary at this time to
reduce a grave danger to covered contractor employees from COVID-19.
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\89\ Note that, in addition to the scope exceptions contained in
the ETS itself, which are discussed in this section, there may be
situations where the ETS does not apply by operation of the OSH Act.
For example, the OSH Act does not apply to working conditions of
employees with respect to which other Federal agencies have
exercised their statutory authority to prescribe or enforce
standards or regulations affecting occupational safety or health
(see 29 U.S.C. 653(b)(1)). Moreover, the ETS does not apply where
states with OSHA-approved occupational safety and health programs
(``State Plans'') have coverage (see 29 U.S.C. 667). State Plans
must adopt and enforce COVID-19 requirements that are at least as
effective as this ETS. Finally, the ETS does not apply to state and
local government employers in states without State Plans (see 29
U.S.C. 652(5)).
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Under Executive Order 14043, every federal agency must implement a
program requiring each of its federal employees to be vaccinated
against COVID-19, except as required by law. 86 FR 50989. OSHA will
regard a federal agency's compliance with this requirement, and the
related Safer Federal Workforce Task Force guidance issued under
section 4(e) of Executive Order 13991 and section 2 of Executive Order
14043 (including guidance on employer support in the form of paid time
for vaccination and paid leave for post-vaccination recovery), as
sufficient to meet its obligation to comply with this ETS under Section
19 of the OSH Act and Executive Order 12196. In essence, the federal
government has chosen the mandatory vaccination option of this rule,
and all federal employees are required to be fully vaccinated by the
compliance date of this standard, except where entitled to a reasonable
accommodation. The Safer Federal Workforce Task Force's guidelines for
vaccination verification are consistent with the ETS's (see Safer
Federal Workforce Task Force, October 11, 2021). Note, however, that
under the OSH Act, the U.S. Postal Service is treated as a private
employer, see 29 U.S.C. 652(5), and it is therefore required to comply
with this ETS in the same manner as any other employer covered by the
Act.
For similar reasons, paragraph (b)(2)(ii) provides that this ETS
does not apply in settings where any employee provides healthcare
services or healthcare support services while they are covered by the
requirements of 29 CFR 1910.502. Section 1910.502 requires a multi-
layered suite of protections for employees covered by its requirements,
including patient screening and management, facemasks or respirators,
other personal protective equipment (PPE), limiting exposure to
aerosol-generating procedures, physical distancing, physical barriers,
cleaning, disinfection, ventilation, health screening and medical
management, access to vaccination, and medical removal protection.
Section 1910.502 was carefully tailored to the healthcare workplaces it
covers and, given the full suite of protections it requires, including
(like this ETS) the provision of paid time for vaccination, OSHA has
determined that it adequately protects the employees covered by its
requirements from the grave danger posed by COVID-19. Therefore,
complying with the additional requirements of this ETS is not necessary
to protect those employees while they are covered by that standard's
protections.
OSHA's intent was to leave no coverage gaps between section
1910.502 and this ETS. In other words, the purpose of paragraph
(b)(2)(ii) is to ensure that all workers in healthcare and healthcare
support jobs who are at grave danger from exposure to SARS-CoV-2 are
protected by either section 1910.502 or this ETS while performing their
jobs. Therefore, it will be necessary for employers with employees
covered by section 1910.502 to determine if they also have employees
covered by this ETS. For example, a healthcare employer with more than
100 employees that has non-hospital ambulatory care facilities that are
exempt under section 1910.502(a)(2)(iii) (for non-hospital ambulatory
care settings where all non-employees are screened prior to entry and
those with suspected or confirmed COVID-19 are prohibited from entry)
would be required to protect the employees in those ambulatory care
facilities under this ETS. Similarly, a retail pharmacy chain that
operates a series of ambulatory care clinics embedded in its stores,
where those embedded clinics are the only areas in the store that are
covered under 1910.502 (see section 1910.502(a)(3)(i)), would have to
ensure that the remainder of its employees in other parts of its stores
are protected under this ETS if the company has 100 or more employees
company-wide, including those covered under 1910.502.
Paragraph (b)(3) provides that, even where the standard applies to
a particular employer, its requirements do not apply to employees: (i)
Who do not report to a workplace where other individuals such as
coworkers or customers are present; (ii) while working from home; or
(iii) who work exclusively outdoors. OSHA intends these provisions to
exempt workplace settings where workers do not interact indoors with
other individuals, and to exempt work performed in the employee's home
regardless of whether other individuals may be present in the home.
OSHA has determined that the provisions of this ETS are not
necessary to protect employees from COVID-19 when they are working
alone, or when they are working from home (see Grave Danger, Section
III.A. of this preamble). These two provisions may overlap in some
cases, but also can apply to slightly different situations. Paragraph
(b)(3)(i) would apply to work in a solitary location, such as a
research station where only one person (the employee) is present at a
time. In that situation, the employee is not exposed to any potentially
infectious individuals at work. Paragraph (b)(3)(ii) would apply to
employees working in their homes, regardless of whether other
individuals who are not employees of the same employer are present. In
a home telework environment, many factors--such as the presence of
family members and other individuals unrelated to the employee's work,
who may not be fully vaccinated or wearing face coverings--may be
beyond the employer's control. Employees are typically in the best
position to manage COVID-19 risks in their homes. Note that the
exemption in paragraph (b)(3)(ii) only applies to employees while they
are working from home. An employee who switches back and forth from
teleworking to working in a setting where other people are present
(e.g., an office) is covered by this ETS and must be vaccinated if
required by the employer. If the employer does not require vaccination,
the teleworking employee must either be vaccinated or complete testing
and wear a face covering in accordance with their
employer's policy under paragraph (d). How often such an employee must
be tested for COVID-19 and wear a face covering, however, depends on
how often they report to the office (see, e.g., paragraph (g)(1)(ii)).
Paragraph (b)(3)(iii) provides that, even if a particular employer
is covered by the standard, the requirements of the standard do not
apply to employees who work exclusively outdoors. OSHA has determined
that COVID-19 does not pose a grave danger to employees who work
exclusively outdoors because of the significantly reduced likelihood of
transmission in outdoor settings. As discussed in more detail in Grave
Danger (Section III.A. of this preamble), the record contains very
little evidence of COVID-19 transmission in outdoor settings. And, in
studies where clusters were identified in worksites characterized as
being outdoors, the study authors were not able to identify specific
incidents that led to transmission. In addition, workplaces
characterized as ``outdoors'' may in fact involve significant time
spent indoors. For example, on a construction site, workers inside a
partially complete structure are not truly outdoors, and some
individuals on a construction site may spend significant amounts of
time in a construction trailer where other individuals are present.
Workers at outdoor locations may also routinely share work vehicles.
These indoor exposures could account for COVID-19 clusters among
employees at worksites otherwise characterized as being outdoors. And
employees whose outdoor time is interrupted by the indoor periods will
still be subject to the requirements in this ETS.
Studies of athletic teams further indicate that evidence of COVID-
19 clusters among workers characterized as working outdoors could
actually be caused by indoor exposures. Even where athletes were in
very close contact during outdoor exposures on the playing field, the
study authors could not identify a single case of COVID-19 transmission
between teams that occurred outdoors (see Mack et al., January 29,
2021; Egger et al., March 18, 2021; Jones et al., February 11, 2021).
For all of these reasons, and as discussed more fully in Grave Danger
(Section III.A. of this preamble), OSHA has determined that COVID-19
does not pose a grave danger to employees who work exclusively
outdoors.
As a practical matter, determining the applicability of paragraph
(b)(3)(iii) depends on the working conditions of individual employees.
For example, if a landscaping contractor has at least 100 employees and
is not covered by the exemptions in paragraph (b)(2), the standard
applies to that employer even if a majority of the company's employees
work exclusively outdoors. The standard's protections would only apply
to employees working in indoor settings around other individuals (other
than telework in their own homes), not to those employees working
exclusively outdoors. In some cases, it may be true that the standard
applies to an employer but the employer would not have to implement its
provisions at all because all of its employees fall within exemptions
in paragraph (b)(3). Going back to the example of the large landscaping
contractor, if all indoor workers either work from home or in locations
where no other individuals are present, and all outdoors workers work
exclusively outdoors and do not drive to worksites together in a
company vehicle, the employer would be covered by the ETS but not
required to comply with its provisions.
An employee will only be covered by the exemption in paragraph
(b)(3)(iii) if the employee works exclusively outdoors. Thus, an
employee who works indoors on some days and outdoors on other days
would not be exempt from the requirements of this ETS. Likewise, if an
employee works primarily outdoors but routinely occupies vehicles with
other employees as part of work duties, that employee is not covered by
the exemption in paragraph (b)(3)(iii). However, if an employee works
outdoors for the duration of every workday except for de minimis use of
indoor spaces where other individuals may be present--such as a multi-
stall bathroom or an administrative office--that employee would be
considered to work exclusively outdoors and covered by the exemption
under paragraph (b)(3)(iii) as long as time spent indoors is brief, or
occurs exclusively in the employee's home (e.g., a lunch break at
home). Extremely brief periods of indoor work would not normally expose
employees to a high risk of contracting COVID-19; however, OSHA will
look at cumulative time spent indoors to determine whether that time is
de minimis. Thus, if there are several brief periods in a day when an
employee goes inside, OSHA will total those periods of time when
determining whether the exception for exclusively outdoors work
applies.
Finally, to qualify for this exception, the employee's work must
truly occur ``outdoors,'' which would not include buildings under
construction where substantial portions of the structure are in place,
such as walls and ceiling elements that would impede the natural flow
of fresh air at the worksite. Workplaces that are truly outdoors
typically do not include any of the characteristics that normally
enable transmission of SARS-CoV-2 to occur, such as poor ventilation,
enclosed spaces, and crowding. As discussed in Bulfone et al. (November
29, 2020), the lower risk of transmission in outdoor settings (i.e.,
open air or structures with only one wall) is likely due to increased
ventilation with fresh air and a greater ability to maintain physical
distancing (see Grave Danger, Section III.A. of this preamble, for more
information on risk of transmission outdoors).
References
Always Designing for People (ADP). (2016, December). Opportunity is
calling. Answer it. Insights and solutions for moving beyond risky
ad hoc HR management. (ADP, December 2016)
Bulfone TC et al. (2020, November 29). Outdoor Transmission of SARS-
CoV-2 and Other Respiratory Viruses: A Systematic Review. (2020).
The Journal of Infectious Diseases 223: 550-561. https://doi.org/10.1093/infdis/jiaa742. (Bulfone et al., November 29, 2020)
Centers for Disease Control and Prevention (CDC). (2021, August 26).
Delta Variant: What We Know About the Science. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11512:cdc%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21. (CDC, August 26, 2021)
Champredon D et al. (2021, May 12). Modelling approach to assessing
risk of transmission of SARS-CoV-2 at gatherings. https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2021-47/issue-4-april-2021/assessing-risk-transmission-sars-cov-2-gatherings.html.
(Champredon et al., May 12, 2021)
Colorado Department of Public Health and Environment (CDPHE). (2021,
October 6). CDPHE COVID-19 outbreak map updated October 6, 2021.
https://cdphe.maps.arcgis.com/apps/webappviewer/index.html?id=dcc0b993632a4bc68dc7b9a1dd015cfe. (CDPHE, October 6,
2021)
Contreras Z et al. (2021, July). Industry Sectors Highly Affected by
Worksite Outbreaks of Coronavirus Disease, Los Angeles County,
California, USA, March 19-September 30, 2020. Emerg Infect Dis.
2021; 27(7): 1769-1775. doi:10.3201/eid2707.210425. (Contreras et
al., July, 2021)
Egger F et al. (2021, March 18). Does playing football (soccer) lead
to SARS-CoV-2 transmission?--a case study of 3 matches with 19
infected football players. Science and Medicine in Football.
doi:10.1080/24733938.2021.1895442. (Egger et al., March 18, 2021)
Jones B et al. (2021, February 11). SARS-CoV-2 transmission during
rugby league matches: do players become infected after participating
with SARS-CoV-2
positive players? Br J Sports Med doi:10.1136/bjsports-2020-103714.
(Jones et al., February 11, 2021)
Mack CD et al. (2021, January 29). Implementation and evolution of
mitigation measures, testing, and contact tracing in the national
football league, August 9-November 21, 2020. MMWR 70: 130-135.
doi:http://dx.doi.org/10.15585/mmwr.mm7004e2. (Mack et al., January
29, 2021)
National Federation of Independent Business (NFIB) Research Center.
(2021, July 12). Covid-19 small business survey (18): federal small
business programs, the vaccine, labor shortage, and supply chain
disruptions. https://assets.nfib.com/nfibcom/Covid-19-18-Questionnaire.pdf. (NFIB, July 12, 2021)
Oregon Health Authority. (2021, October 6). COVID-19 weekly outbreak
report--October 6, 2021. https://www.oregon.gov/oha/covid19/Documents/DataReports/Weekly-Outbreak-COVID-19-Report.pdf. (Oregon
Health Authority, October 6, 2021)
Safer Federal Workforce Task Force. (2021, September 24). COVID-19
Workplace Safety: Guidance for Federal Contractors and
Subcontractors. https://www.saferfederal/workforce./gov/downloads/Draft%/20contractor%/20guidance%/20doc_20210922.pdf. (Safer Federal
Workforce Task Force, September 24, 2021)
Safer Federal Workforce Task Force. (2021, October 11).
Vaccinations: Vaccination Documentation and Information. https://www.saferfederalworkforce.gov/faq/vaccinations/. (Safer Federal
Workforce Task Force, October 11, 2021)
Shacham E et al. (2021, July 5). Examining the relationship between
COVID-19 vaccinations and reported incidence. doi:https://doi.org/10.1101/2021.06.30.21259794. (Shacham et al., July 5, 2021)
Society for Human Resource Management (SHRM). (2015). How
organizational staff size influences HR metrics. https://www.shrm.org/resourcesandtools/business-solutions/documents/organizational%20staff%20size.pdf. (SHRM, 2015)
Society for Human Resource Management (SHRM). (2020a, May 6).
Navigating COVID-19: impact of the pandemic on small businesses.
https://shrm.org/hr-today/trends-and-forecasting/research-andsurveys/Documents/SHRM%20CV19%20SBO%20Research%20Presentation%20v1.1.pdf. (SHRM, May
6, 2020a)
Society for Human Resource Management (SHRM). (2020b, May 6).
Survey: COVID-19 could shutter most small businesses. https://www.shrm.org/about-shrm/press-room/press-releases/pages/survey-covid-19-could-shutter-most-small-businesses.aspx. (SHRM, May 6,
2020b)
United States (US) Census Bureau. (2021, May). 2017 SUSB Annual Data
Tables by Establishment Industry, The annual data table titled
``U.S. & states, NAICS, detailed employment sizes U.S., 6-digit and
states, NAICS sector,'' https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html. (US Census Bureau, May 2021)
C. Definitions
Paragraph (c) of the ETS provides definitions of terms used in the
section.
``Assistant Secretary'' means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
This definition provides clarification about who can request and
receive records specified in paragraph (l)(3) of this section. A
designee includes a representative conducting an inspection or an
investigation.
``COVID-19 (Coronavirus Disease 2019)'' means the disease caused by
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). SARS-CoV-
2 is a highly transmissible virus that spreads primarily through the
respiratory droplets that are produced when an infected person coughs,
sneezes, sings, talks, or breathes. The nature of the disease, variants
of SARS-CoV-2, disease transmission, and associated health effects are
all described in great detail in Grave Danger (Section III.A. of this
preamble). For clarity and ease of reference, the ETS also uses the
term ``COVID-19'' when describing exposures or potential exposures to
SARS-CoV-2. The requirements of the ETS are intended to address the
grave danger of exposure to COVID-19 in the workplace.
A ``COVID-19 test'' means a test for SARS-CoV-2 that is: (1)
Cleared, approved, or authorized, including in an Emergency Use
Authorization (EUA), by the U.S. Food and Drug Administration (FDA) to
detect current infection with the SARS-CoV-2 virus (e.g., a viral
test); (2) administered in accordance with the authorized instructions;
and (3) not both self-administered and self-read unless observed by the
employer or an authorized telehealth proctor. Examples of tests that
satisfy this requirement include tests with specimens that are
processed by a laboratory (including home or on-site collected
specimens which are processed either individually or as pooled
specimens), proctored over-the-counter tests, point of care tests, and
tests where specimen collection and processing is either done or
observed by an employer.
Under paragraph (g), employees who are not fully vaccinated must be
tested for COVID-19. When an employee must be tested, the test is
considered acceptable only if the test and the administration of the
test satisfy the definition of COVID-19 test in this standard.
COVID-19 tests can broadly be divided into two categories,
diagnostic tests and antibody tests. Diagnostic tests detect parts of
the SARS-CoV-2 virus and can be used to diagnose current infection. On
the other hand, antibody tests look for antibodies in the immune system
produced in response to SARS-CoV-2, and are not used to diagnose an
active COVID-19 infection. Antibody tests do not meet the definition of
COVID-19 test for the purposes of this ETS.
Diagnostic tests for current infection fall into two categories:
Nucleic acid amplification tests (NAATs) and antigen tests. NAATs are a
type of molecular test that detect genetic material (nucleic acids);
NAATs for COVID-19 identify the ribonucleic acid (RNA) sequences that
comprise the genetic material of the virus. NAATs can reliably detect
small amounts of SARS-CoV-2 and are unlikely to return a false-negative
result. NAATs use many different methods to detect the virus, including
reverse transcription-polymerase chain reaction (RT-PCR), which is a
high-sensitivity, high-specificity \90\ test for diagnosing SARS-CoV-2
infection. Other types of NAATs that use isothermal amplification
methods include nicking endonuclease amplification reaction (NEAR),
transcription mediated amplification (TMA), loop-mediated isothermal
amplification (LAMP), helicase-dependent amplification (HDA), clustered
regularly interspaced short palindromic repeats (CRISPR), and strand
displacement amplification (SDA) (CDC, June 14, 2021).
---------------------------------------------------------------------------
\90\ Test sensitivity indicates the ability of a test to
correctly identify people who have a disease. Test specificity
indicates the ability of a test to correctly identify people who do
not have a disease. A test with high sensitivity and high
specificity minimizes inaccurate results.
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Most NAATs need to be processed in a laboratory with variable time
to receive results (approximately 1-2 days), but some NAATs are point-
of-care tests with results available in about 15-45 minutes. As of
October 14, 2021, 264 molecular tests (NAATs) and collection devices
have EUA from the FDA for COVID-19 (FDA, October 14, 2021b). These
tests may be acceptable under the ETS.
Antigen tests may also meet the definition of COVID-19 test under
this standard. Antigen tests indicate current infection by detecting
the presence of a specific viral antigen. Most can be processed at the
point of care with results available in about 1530 minutes. Antigen
tests generally have similar specificity to, but are less sensitive
than, NAATs (CDC, October 7, 2021). As of October 14, 2021, thirty-
seven antigen
tests have EUA from the FDA for COVID-19 (FDA, October 14, 2021a).
These tests may be acceptable under the ETS.
Most antigen tests and some NAATs are conducted at the point of
care, which means the test processing and result reading is performed
at or near the place where a specimen is collected so that results can
be obtained within minutes rather than hours or days. Rapid point-of-
care tests are administered in various settings operating under a
Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate
of waiver, such as physician offices, urgent care facilities,
pharmacies, school health clinics, workplace health clinics, long-term
care facilities and nursing homes, and at temporary locations, such as
drive-through sites managed by local health organizations (FDA,
November 16, 2020).
To be a valid COVID-19 test under this standard, a test may not be
both self-administered and self-read unless observed by the employer or
an authorized telehealth proctor. OSHA included the requirement for
some type of independent confirmation of the test result in order to
ensure the integrity of the result given the ``many social and
financial pressures for test-takers to misrepresent their results''
(Schulte et al., May 19, 2021). This independent confirmation can be
accomplished in multiple ways, including through the involvement of a
licensed healthcare provider or a point-of-care test provider. If an
over-the-counter (OTC) test is being used, it must be used in
accordance with the authorized instructions. The employer can validate
the test through the use of a proctored test that is supervised by an
authorized telehealth provider. Alternatively, the employer could
proctor the OTC test itself.
Employers have the flexibility to select the testing scenario that
is most appropriate for their workplace. Some employees and employers
may rely on testing that is conducted by a healthcare provider (e.g.,
doctor or nurse) who arranges for the specimen to be analyzed at a
laboratory or at a point-of-care testing location (e.g., a pharmacy).
The involvement of licensed or accredited healthcare providers allows
employers to have a high degree of confidence in the suitability of the
test and the test results. Some large employers who set up their own
on-site testing program may partner with a healthcare organization
(e.g., a local hospital or clinic) or rely on a licensed healthcare
provider to help obtain a CLIA certificate of waiver. Other employers
may simply require that employees perform and read their own OTC test
while an authorized employee observes the administration and reading of
the test to ensure that a new test kit was used and that the test was
administered properly (e.g., nostrils were swabbed), and to witness the
test result.
Due to the potential for employee misconduct (e.g., falsified
results), tests that are both self-administered and self-read are not
acceptable unless they are observed by the employer or an authorized
telehealth proctor. Some COVID-19 tests are authorized by the FDA to be
performed only with the supervision of a telehealth proctor, which is
someone who is trained to observe sample collection and provide
instructions and result interpretation assistance to individuals using
the test. The term ``authorized telehealth proctor'' refers to proctors
who follow the requirements for proctoring specified by the FDA
authorization. For a more detailed discussion on COVID-19 testing
requirements under this ETS, see the Summary and Explanation for
paragraph (g) (Section VI.G. of this preamble).
A ``face covering'' means a covering that: (1) Completely covers
the nose and mouth; (2) is made with two or more layers of a breathable
fabric that is tightly woven (i.e., fabrics that do not let light pass
through when held up to a light source); (3) is secured to the head
with ties, ear loops, or elastic bands that go behind the head. If
gaiters are worn, they should have two layers of fabric or be folded to
make two layers; (4) fits snugly over the nose, mouth, and chin with no
large gaps on the outside of the face; and (5) is a solid piece of
material without slits, exhalation valves, visible holes, punctures, or
other openings. This definition includes clear face coverings or cloth
face coverings with a clear plastic panel that, despite the non-cloth
material allowing light to pass through, otherwise meet this definition
and which may be used to facilitate communication with people who are
deaf or hard-of-hearing or others who need to see a speaker's mouth or
facial expressions to understand speech or sign language respectively.
Face coverings can be manufactured or homemade, and they can
incorporate a variety of designs, structures, and materials. Face
coverings provide variable levels of protection based on their design
and construction.
As explained in paragraph (i), face covering use is required based
on an employee's vaccination status. The criteria in the definition
help to ensure that face coverings that are worn by workers who are not
fully vaccinated will provide effective source control and some degree
of personal protection. Source control means reducing the spread of
large respiratory droplets to others by covering a person's mouth and
nose. The personal protection afforded by face coverings, as well as
the benefits and necessity, are described in the Summary and
Explanation for paragraph (i) (Section VI.I. of this preamble).
Face coverings differ from facemasks and respirators, which are
also defined in paragraph (c) of this section. Face coverings, unlike
facemasks and respirators, are not considered to be personal protective
equipment (PPE) under OSHA's general PPE standard (29 CFR 1910.132), as
discussed in the Summary and Explanation for paragraph (i) (Section
VI.I. of this preamble).
Lastly, face coverings as required by this standard do not have to
meet a consensus standard, although face coverings that adhere to such
consensus standards, with design and construction specifications, meet
the definition and may offer both greater protection and the confidence
that at least a minimum level of protection has been provided. The
National Institute for Occupational Safety and Health (NIOSH)
recommends that employers and workers who want a face covering that
provides a known level of protection use face coverings that meet a new
standard, called Workplace Performance and Workplace Performance Plus
masks, for workplaces. As discussed in the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble), the new NIOSH criteria
and the ASTM Specification for Barrier Face Coverings, F3502-21 (ASTM
Standard) provide a greater level of source control performance for
workers when wearing the face covering according to manufacturer's
instructions. The NIOSH criteria require that face coverings conform to
the ASTM Standard and meet additional quantitative leakage criteria.
Although not required by the standard, OSHA notes that face coverings
that meet ASTM F3502-21 requirements and the new NIOSH criteria may
offer a higher level of source control and wearer protection than those
face coverings that do not meet a consensus standard.
A ``facemask'' means a surgical, medical procedure, dental, or
isolation mask that is FDA-cleared, authorized by an FDA EUA, or
offered or distributed as described in an FDA enforcement policy.
Facemasks may also be referred to as ``medical procedure masks.'' This
definition provides clarification about the exception to the face
covering
requirement under paragraph (i)(1)(iii) that permits facemask use in
lieu of face coverings. OSHA notes that facemasks are not respirators,
which are also defined in this section.
Facemasks provide protection against exposure to splashes, sprays,
and spatter of body fluids. Facemasks offer both source control, as
defined in this section under face coverings, and protection for the
wearer. OSHA has previously established that facemasks are essential
PPE for employees in healthcare, under both the general PPE standard
(29 CFR part 1910.132) and the Bloodborne Pathogens standard (29 CFR
part 1910.1030). Although not required, the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble) addresses their
inclusion in this standard. Additional information on such facemasks
can be found in relevant FDA guidance.
``Fully vaccinated'' means (i) a person's status 2 weeks after
completing primary vaccination with a COVID-19 vaccine with, if
applicable, at least the minimum recommended interval between doses in
accordance with the approval, authorization, or listing that is: (A)
Approved or authorized for emergency use by the FDA; (B) listed for
emergency use by the World Health Organization (WHO); or (C)
administered as part of a clinical trial at U.S. site, if the recipient
is documented to have of primary vaccination with the ``active'' (not
placebo) COVID-19 vaccine candidate, for which vaccine efficacy has
been independently confirmed (e.g., by a data and safety monitoring
board) or if the clinical trial participant from the U.S. sites had
received a COVID-19 vaccine that is neither approved nor authorized for
use by the FDA but is listed for emergency use by the WHO. Currently-
authorized FDA vaccines include Janssen (Johnson & Johnson), which is a
single-dose primary vaccination, and Pfizer-BioNTech and Moderna, which
have a two-dose primary vaccination series. This definition is
consistent with the CDC definition of fully vaccinated (CDC, September
16, 2021).
The definition of ``fully vaccinated'' also means a person's status
2 weeks after receiving the second dose of any combination of two doses
of a COVID-19 vaccine that is approved or authorized by the FDA, or
listed as a two-dose series by the WHO (i.e., heterologous primary
series of such vaccines, receiving doses of different COVID-19 vaccines
as part of one primary series). The second dose of the series must not
be received earlier than 17 days (21 days with a 4-day grace period)
after the first dose (CDC, October 15, 2021). OSHA has included this
because people who have received a heterologous primary vaccination
series (including mixing of mRNA, adenoviral, and mRNA plus adenoviral
products) are considered by the CDC to also meet this definition. OSHA
considers a vaccination series that meets the definition in
subparagraph (ii) to be a primary vaccination for purposes of the
requirements to support vaccination in paragraph (f).
The employer obligations under the ETS differ based on whether each
employee is fully vaccinated. This definition is relevant to the
definition of mandatory vaccination policy, in this paragraph (c), as
well as the provisions under paragraph (d) regarding written
vaccination policy requirements and relevant procedures for workers who
are fully vaccinated. Paragraph (e)(2) also addresses fully vaccinated
employees, including the determination of vaccination status and
acceptable forms of proof. Lastly, the definition provides clarity with
regard to the requirements of paragraphs (g) and (i) respectively,
which contain requirements for regular COVID-19 testing and face
covering use among employees who are not fully vaccinated.
Paragraph (e) requires employers to determine each employee's
vaccination status, including whether they are fully or partially
vaccinated. By ``partially vaccinated,'' OSHA means someone who has
started a primary vaccination series but not completed it (e.g., has
received one dose of a two-dose series) or has completed their primary
vaccination and two weeks have not elapsed since the last dose of the
primary vaccination.
A ``mandatory vaccination policy'' is an employer policy requiring
each employee to be fully vaccinated. To meet the definition of a
mandatory vaccination policy, the policy must require: Vaccination of
all employees, including vaccination of all new employees as soon as
practicable, other than those employees (1) for whom a vaccine is
medically contraindicated, (2) for whom medical necessity requires a
delay in vaccination,\91\ or (3) who are legally entitled to a
reasonable accommodation under federal civil rights laws because they
have a disability or sincerely held religious beliefs, practices, or
observances that conflict with the vaccination requirement. OSHA
intends that ``employee,'' as used in this definition, includes only
employees that are covered by this ETS and does not include employees
who are excluded from coverage under paragraph (b)(3).
---------------------------------------------------------------------------
\91\ As defined by CDC's informational document, Summary
Document for Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Authorized in the United States (CDC, September
29, 2021).
---------------------------------------------------------------------------
Paragraph (d)(1) of the standard requires an employer to establish,
implement, and enforce a written mandatory vaccination policy that
meets this definition. The benefits of vaccination, including the
effectiveness of vaccination mandates, are discussed in Grave Danger
(Section III.A. of this preamble) and Need for the ETS (Section III.B.
of this preamble).
OSHA recognizes that vaccination policies may vary, as indicated in
paragraph (d)(2). Any policy that permits the employee to choose
between vaccination and COVID-19 testing and face covering use would
not be considered a mandatory vaccination policy under paragraph
(d)(1), although such policy is permissible under paragraph (d)(2). In
some cases, employers may implement vaccination policies that differ by
location or type of business operation and thus the application of
paragraph (d)(2) might vary across an employer's workforce. This is
discussed in greater detail in the Summary and Explanation for
paragraph (d) (Section VI.D. of this preamble).
A ``respirator'' is a type of PPE that is certified by NIOSH under
42 CFR part 84 or is authorized under an EUA by the FDA. These
specifications are intended to ensure some consistent level of testing,
approval, and protection and to prevent the use of counterfeit
respirators that will not offer adequate protection, which is important
because respirators are intended to protect the wearer when directly
exposed to hazards. Respirators protect against airborne hazards by
removing specific air contaminants from the ambient (surrounding) air
or by supplying breathable air from a safe source. Common types of
respirators include filtering facepiece respirators (e.g., N95),
elastomeric respirators, and powered air-purifying respirators (PAPRs).
Face coverings, facemasks, and face shields are not respirators.
As stated above, there are various types of respirators that would
fall within this definition. A filtering facepiece respirator (FFR) is
a negative-pressure particulate respirator with a non-replaceable
filter as an integral part of the facepiece or with the entire
facepiece composed of the non-replaceable filtering medium. N95 FFRs
are the most common type of FFR and are the type of respirator most
often used to control exposures to infections transmitted via the
airborne route. When properly worn, N95 FFRs filter at least 95% of
airborne particles. An
elastomeric respirator is a tight-fitting respirator with a facepiece
that is made of synthetic or rubber material that permits it to be
disinfected, cleaned, and reused according to the manufacturer's
instructions. Elastomeric respirators are equipped with replaceable
cartridges, canisters, or filters. Lastly, a powered air-purifying
respirator (PAPR) is an air-purifying respirator that uses a blower to
force the ambient air through air-purifying elements to the inlet
covering.
This standard does not require the use of respirators. This
definition is included because it relates to paragraph (i)(1)(iii),
which exempts employees from wearing face coverings when they are
wearing respirators or facemasks. In addition, paragraph (i)(4)
requires employers to permit employees to wear a respirator instead of
a face covering and permits employers to provide respirators to their
employees, instead of face coverings. When respirators are used
pursuant to paragraph (i)(4), the employer must also comply with Sec.
1910.504, the Mini Respiratory Protection Program.
NIOSH has developed a set of regulations in 42 CFR part 84 for
testing and certifying non-powered, air-purifying, particulate-filter
respirators. To help address concerns about availability during the
COVID-19 pandemic, the FDA has issued EUAs for certain PPE products,
including respiratory protective devices such as respirators. For the
purposes of this standard, respirators certified by NIOSH, under 42 CFR
part 84 or authorized under an EUA by the FDA meet the definition.
Additional information on such respirators can be found in relevant FDA
and NIOSH guidance.
A ``workplace'' is a physical location (e.g., fixed, mobile) where
the employer's work or operations are performed. It does not include an
employee's residence, even if the employee is teleworking from their
residence. Examples of fixed locations include: Offices, retail
establishments, co-working facilities, and factories or manufacturing
facilities. A workplace includes the entire site (including outdoor and
indoor areas, a structure or a group of structures) or an area within a
site where work or any work-related activity occurs (e.g., taking
breaks, going to the restroom, eating, entering or exiting work). The
workplace includes the entirety of any space associated with the site
(e.g., workstations, hallways, stairwells, breakrooms, bathrooms,
elevators) and any other space that an employee might occupy in
arriving, working, or leaving. Examples of employees who have mobile
workplaces include maintenance and repair technicians who go to homes
or businesses to provide repair services, or those who provide delivery
services.
References
Centers for Disease Control and Prevention (CDC). (2021, June 14).
Nucleic Acid Amplification Tests. https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html. (CDC, June 14, 2021).
Centers for Disease Control and Prevention (CDC). (2021, September
16). When You've Been Fully Vaccinated: How to Protect Yourself and
Others. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. (CDC, September 16, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
29). Summary Document for Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October 7).
Interim Guidance for SARS-CoV-2 Testing in Non-Healthcare
Workplaces. https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-workplaces.html. (CDC, October
7, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
15). Interim Public Health Recommendations for Fully Vaccinated
People. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, October 15, 2021)
Equal Employment Opportunity Commission (EEOC). (2021, October 25).
What You Should Know About COVID-19 and the ADA, the Rehabilitation
Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
(EEOC, October 25, 2021)
Food and Drug Administration (FDA). (2020, November 16). COVID-19
Test Settings: FAQs on Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2. (FDA, November 16, 2020)
Food and Drug Administration (FDA). (2021a, October 14). In Vitro
Diagnostics EUAs--Antigen Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021a)
Food and Drug Administration (FDA). (2021b, October 14)). In Vitro
Diagnostics EUAs--Molecular Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021b)
Schulte P et al. (2021, May 19). Proposed Framework for Considering
SARS-CoV-2 Antigen Testing of Unexposed Asymptomatic Workers in
Selected Workplaces. J Occup Environ Med. 2021 Aug; 63(8): 646-656.
Published online 2021, May 19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327768/. (Schulte et al., May 19, 2021)
D. Employer Policy on Vaccination
Vaccination is a vital tool to reduce the presence and severity of
COVID-19 cases in the workplace, in communities, and in the nation as a
whole. Despite the robust protection against COVID-19 that vaccination
affords, millions of eligible individuals have not yet been vaccinated.
Current efforts to increase the proportion of the U.S. population that
is fully vaccinated against COVID-19 are critical to ending the COVID-
19 pandemic (CDC, September 15, 2021). As described more fully in Need
for the ETS (Section III.B. of this preamble), mandatory vaccination
policies work. Therefore, OSHA has determined that requiring or
strongly encouraging vaccination--the most effective and efficient
control for reducing COVID-19--is key to ensuring the protection of
workers against the grave danger of exposure to SARS-CoV-2 in the
workplace (see Grave Danger, Section III.A. of this preamble).
Therefore, this ETS requires employers to adopt mandatory vaccination
policies for their workplaces, with an exception for employers that
instead adopt a policy allowing employees to elect to undergo regular
COVID-19 testing and wear a face covering at work in lieu of
vaccination. In Need for the ETS (Section III.B of this preamble), OSHA
explains its rationale for providing the exception.
Paragraph (d) of this ETS is a critical element in ensuring
employees' protection, as it requires covered employers to develop,
implement, and enforce written policies on COVID-19 vaccination for
their workforces. Paragraph (d)(1) requires the employer to establish,
implement, and enforce a written mandatory vaccination policy. As
defined in paragraph (c), a mandatory vaccination policy is an employer
policy requiring each employee to be fully vaccinated. Such a policy
must require vaccination of all employees, other than those employees
who fall into one of three categories: (1) Those for whom a vaccine is
medically contraindicated, (2) those for whom medical necessity
requires a delay in
vaccination, or (3) those who are legally entitled to a reasonable
accommodation under federal civil rights laws because they have a
disability or sincerely held religious beliefs, practices, or
observances that conflict with the vaccination requirement. The policy
must also require all new employees to be vaccinated as soon as
practicable.
Paragraph (d)(2) is a limited exemption from the mandatory
vaccination policy requirement. As discussed in Need for the ETS
(Section III.B. of this preamble), vaccination mandates are effective
at increasing overall vaccination rates and protecting employees and,
therefore, the agency encourages all employers to implement a mandatory
vaccination policy. Under paragraph (d)(2), however, employers can
avoid the mandate in paragraph (d)(1) if the employer establishes,
implements, and enforces a written policy allowing any employee not
subject to a mandatory vaccination policy to choose either to: (1) Be
fully vaccinated against COVID-19 or (2) provide proof of regular
testing for COVID-19 in accordance with paragraph (g) of this section
and wear a face covering in accordance with paragraph (i). An employer
who chooses to operate under paragraph (d)(2), however, must still
offer the support for vaccination required under paragraph (f) and may
not prevent employees from getting vaccinated. Adopting a policy under
paragraph (d)(2) simply means that employees themselves may choose not
to get vaccinated, in which case they must get tested and wear face
coverings per the requirements of the standard.
OSHA recognizes there may be employers who develop and implement
partial mandatory vaccination policies, i.e., that apply to only a
portion of their workforce. An example might be a retail corporation
employer who has a mixture of staff working at the corporate
headquarters, performing intermittent telework from home, and working
in stores serving customers. In this type of situation, the employer
may choose to require vaccination of only some subset of its employees
(e.g., those working in stores), and to treat vaccination as optional
for others (e.g., those who work from headquarters or who perform
intermittent telework). This approach would comply with the standard so
long as the employer complies in full with paragraph (d)(1) and (d)(2)
for the respective groups.
OSHA uses the terms establish, implement, and enforce in paragraph
(d) to emphasize that it is necessary for an employer to first
determine its policy and create a written record of that policy. After
determining the policy, an employer must then ensure that it is
following the policy, as laid out in its written plan. Finally,
employers must ensure that they enforce the requirements of their
policies with respect to their workforce, through training and the use
of such mechanisms as work rules and the workplace disciplinary system,
if necessary. These requirements apply to the written policy required
under paragraph (d), whether employers choose to implement the
mandatory vaccination policy under paragraph (d)(1) or utilize the
exemption under paragraph (d)(2) for all or a portion of their
workforce.
To ensure that employers' vaccination policies under paragraph (d)
are comprehensive and effective, the policies should address all of the
applicable requirements in paragraphs (e)-(j) of this standard,
including: Requirements for COVID-19 vaccination; applicable exclusions
from the written policy (e.g., medical contraindications, medical
necessity requiring delay in vaccination, or reasonable accommodations
for workers with disabilities or sincerely held religious beliefs);
information on determining an employee's vaccination status and how
this information will be collected (as described in paragraph (e));
paid time and sick leave for vaccination purposes (as described in
paragraph (f)); notification of positive COVID-19 tests and removal of
COVID-19 positive employees from the workplace (as described in
paragraph (h)); information to be provided to employees (pursuant to
paragraph (j)--e.g., how the employer is making that information
available to employees); and disciplinary action for employees who do
not abide by the policy. In addition to addressing the requirements of
paragraphs (e)-(j) of this standard, the employer should include all
relevant information regarding the policy's effective date, who the
policy applies to, deadlines (e.g., for submitting vaccination
information, for getting vaccinated), and procedures for compliance and
enforcement, all of which are necessary components of an effective
plan. Having a comprehensive written policy will provide a solid
foundation for an effective COVID-19 vaccination program, while making
it easier for employers to inform employees about the program-related
policies and procedures, as required under paragraph (j)(1).
If an employer utilizes the exemption under paragraph (d)(2), its
workplace may contain employees who are vaccinated and unvaccinated.
This might be the case even for employers who establish a mandatory
vaccination policy under paragraph (d)(1); for example, an employer
with a mandatory vaccination policy might have employees who cannot be
vaccinated for medical reasons. Given the additional safety protocols
under this standard for individuals who are not fully vaccinated (see
paragraphs (g) and (i)), an employer who has both vaccinated and
unvaccinated employees will have to develop and include the relevant
procedures for two sets of employees in the written policy. The
procedures for those who are fully vaccinated should contain all the
information previously discussed relevant to establishing,
implementing, and enforcing a comprehensive written policy. However,
the procedures applicable to employees who are not fully vaccinated
(i.e., those who decline vaccination, those who are unable to receive
vaccination and are, absent undue hardship to their employers, entitled
to reasonable accommodation) and those who are unable to provide proof
of vaccination as required by paragraph (e) (who must be treated as not
fully vaccinated), must include COVID-19 testing and face covering use
as required by paragraphs (g) and (i), respectively, unless the
reasonable accommodation from vaccination removes the employee from the
scope of Sec. 1910.501 (e.g., full time telework consistent with one
of the exceptions in Sec. 1910.501(b)(3)). OSHA intends that such an
employer will develop one written plan that includes different policies
and procedures for vaccinated and unvaccinated employees. The
requirements of paragraphs (e), (f), (h), and (j) should be addressed
in the policy regardless of the vaccination requirements adopted by the
employer.
As with all elements of the written plan, an effective written plan
will explain the testing requirements contained in paragraph (g) for
unvaccinated employees, and how the employer will implement and enforce
those policies. As described in paragraph (g)(1), the testing
requirements differ for employees who report at least once every 7 days
to a workplace compared to those who do not. Thus, the policy may
describe different testing procedures for those different groups of
employees, depending on how often they physically report to a workplace
where other individuals are present. As described in paragraph (g)(3),
the testing requirements are temporarily suspended for 90 days
following a positive COVID-19 test or diagnosis. Thus, the employer's
policy and procedures to implement this temporary suspension of
testing should be included in their written workplace policy. In
addition to the testing requirements in paragraph (g), an effective
policy must address mandatory face covering use as described in
paragraph (i), including procedures for employee compliance. Employers
can get more information on the requirements for paragraphs (e) through
(j), and what they must do to comply with those provisions of the
standard, in the relevant Summary and Explanation sections (see Section
VI. of this preamble).
As an employer develops their written policy, they must address how
the policy will apply to new employees. Although many new hires will be
fully vaccinated, there should be procedures within the plan to collect
information about the new employee's vaccination status, and determine
when an unvaccinated new hire must be vaccinated and, for employers
using a plan under paragraph (d)(2), when COVID-19 testing and face
covering use will commence if an employee remains unvaccinated. All new
hires should be treated similarly to any employee who has not entered
the workplace in the last seven days and will need to be fully
vaccinated or provide proof of a negative COVID-19 test within the last
seven days prior to entering the workplace for the first time. It is
not OSHA's intention to discourage employers from hiring new employees,
but rather to ensure that new employees are as well-protected from
COVID-19 hazards in the workplace as current employees and are less
likely to spread the virus to other employees.
An employer may have already developed and implemented a written
policy on vaccination, testing, and/or face covering use to protect
employees from COVID-19. It is not OSHA's intent for employers to
duplicate current effective policies covering the requirements of this
ETS; however, each employer with a current policy must evaluate that
policy to ensure it satisfies all of the requirements of this rule.
Employers with existing policies must modify and/or update their
current policies to incorporate any missing required elements, and must
provide information on these new updates or modifications to all
employees in accordance with paragraph (j)(1). Once the employer has
developed its policy pursuant to paragraph (d), the policy must be
reduced to writing in order to be compliant with paragraph (d).
The note to paragraph (d) was included in recognition that, under
federal law, some employees may be entitled to a reasonable
accommodation from their employer, absent undue hardship. If the worker
requesting a reasonable accommodation cannot be vaccinated and/or wear
a face covering because of a disability, as defined by the Americans
with Disabilities Act (ADA), that worker may be entitled to a
reasonable accommodation. In addition, if the vaccination, and/or
testing for COVID-19, and/or wearing a face covering conflicts with a
sincerely held religious belief, practice or observance, a worker may
be entitled to a reasonable accommodation. Such accommodations exist
independently of the Occupational Safety and Health Act and, therefore,
OSHA does not administer or enforce these laws. Examples of relevant
federal laws under which an accommodation can be requested include the
Americans with Disabilities Act (ADA) and Title VII of the Civil Rights
Act of 1964.
For more information, the note refers to a resource produced by the
Equal Employment Opportunity Commission (EEOC), which is responsible
for enforcing federal laws that prohibit employment-related
discrimination based on a person's race, color, religion, sex
(including pregnancy, gender identity, and sexual orientation),
national origin, age (40 or older), disability, or genetic information.
The EEOC resource listed in the note, What You Should Know About COVID-
19 and the ADA, the Rehabilitation Act, and Other EEO Laws, available
at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws, should be helpful to
employers in navigating employees' requests for accommodations,
including the process for determining a reasonable accommodation and
information on undue hardship (EEOC, October 25, 2021). An additional
resource that might be helpful is the CDC's informational document,
Summary Document for Interim Clinical Considerations for Use of COVID-
19 Vaccines Currently Authorized in the United States (CDC, September
29, 2021), which lists the recognized clinical contraindications to
receiving a COVID-19 vaccine.
References
Centers for Disease Control and Prevention (CDC). (2021, September
15). Science Brief: Background rationale and evidence for public
health recommendations for fully vaccinated people. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. (CDC, September 15, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
29). Summary Document for Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
Equal Employment Opportunity Commission (EEOC). (2021, October 25).
What You Should Know About COVID-19 and the ADA, the Rehabilitation
Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
(EEOC, October 25, 2021)
E. Determination of Employee Vaccination Status
To comply with the requirements of the standard, it is essential
that employers are aware of each employee's vaccination status. As
discussed in the Summary and Explanation for paragraph (d) (Section
VI.D. of this preamble), effective implementation and enforcement of a
written vaccination policy requires the employer to know the
vaccination status of all employees. Furthermore, the employer must
know each employee's vaccination status in order to ensure that the
vaccination, testing, and face covering requirements of the standard
are met. As such, paragraph (e) includes provisions for determining
each employee's vaccination status. The standard requires employers to
determine the vaccination status of each employee (paragraph (e)(1)),
and also to maintain records of each employee's vaccination status,
preserve acceptable proof of vaccination for each employee who is fully
or partially vaccinated, and maintain a roster of each employee's
vaccination status (paragraph (e)(4)). As discussed more fully below,
maintenance of records in accordance with this paragraph is subject to
applicable legal requirements for confidentiality of medical
information. Additional provisions in paragraph (e) define acceptable
proof of vaccination status for vaccinated employees (paragraph (e)(2))
and provide that any employee who does not submit an acceptable form of
proof of vaccination status must be treated as not fully vaccinated
(paragraph (e)(3)).
Paragraph (e)(1) requires the employer to determine the vaccination
status of each employee, including whether the employee is fully
vaccinated. Under paragraph (e)(2), the employer must require each
vaccinated employee to provide acceptable proof of vaccination status,
including whether they are fully or partially vaccinated. This is an
ongoing requirement for the employer (i.e., the employer needs to
update this information as employees proceed through the vaccination
process).
Paragraph (e)(2) defines what ``acceptable proof of vaccination
status'' means for purposes of the ETS, and
employers must accept any of the proofs listed in accordance with the
terms of the standard and as explained more fully below. Under
paragraph (e)(2), the following are acceptable for proof of
vaccination: (i) The record of immunization from a health care provider
or pharmacy; (ii) a copy of the U.S. CDC COVID-19 Vaccination Record
Card (CDC Form MLS-319813_r, published on September 3, 2020) (CDC,
October 5, 2021); (iii) a copy of medical records documenting the
vaccination; (iv) a copy of immunization records from a public health,
state, or tribal immunization information system; or (v) a copy of any
other official documentation that contains the type of vaccine
administered, date(s) of administration, and the name of the health
care professional(s) or clinic site(s) administering the vaccine(s).
To be acceptable as proof of vaccination, any documentation should
generally include the employee's name, type of vaccine administered,
date(s) of administration, and the name of the health care
professional(s) or clinic site(s) administering the vaccine(s). In some
cases, state immunization records may not include one or more of these
data fields, such as clinic site; in those circumstances, an employer
can still rely upon the State immunization record as acceptable proof
of vaccination. OSHA notes that clinic sites can include temporary
vaccination facilities used during large vaccine distribution
campaigns, such as schools, churches, or sports stadiums. Copies,
including digital copies, of the listed forms of proof are acceptable
means of documentation so long as they clearly and legibly display the
necessary information. Digital copies can include, for example, a
digital photograph, scanned image, or PDF of an acceptable form of
proof. Some state governments are utilizing digital COVID-19 vaccine
records showing the same information as the U.S. CDC COVID-19
Vaccination Record Card (CDC Form MLS-319813_r, published on September
3, 2020) and providing quick response (QR) codes that when scanned will
provide the same information (see, e.g., New York State Government,
n.d., Retrieved October 4, 2021). In certain states, the QR code
confirms the vaccine record as an official record of the state (see,
e.g., State of California, n.d., Retrieved October 7, 2021) and
therefore would provide acceptable proof of vaccination under the ETS
(see paragraph (e)(2)(iv)). However, as discussed later, the employer
must retain a copy of the vaccination information retrieved when the QR
code is scanned, not just the QR code itself, to comply with paragraph
(e)(4). In requesting proof of vaccination, the employer must take care
to comply with any applicable Federal laws, including requirements
under the Privacy Act, 5 U.S.C. 552a, and the Americans with
Disabilities Act (ADA), 42 U.S.C. 12101 et seq.
Each employee who has been partially or fully vaccinated should be
able to provide one of the forms of acceptable proof listed above
(paragraphs (e)(2)(i)-(e)(2)(v)). An employee who does not possess
their COVID-19 vaccination record (e.g., because it was lost or stolen)
should contact their vaccination provider (e.g., local pharmacy,
physician's office) to obtain a new copy or utilize their state health
department's immunization information system. In instances where an
employee is unable to produce acceptable proof of vaccination under
paragraphs (e)(2)(i)-(e)(2)(v), paragraph (e)(2)(vi) provides that a
signed and dated statement by the employee will be acceptable. The
employee's statement must: (A) Attest to their vaccination status
(fully vaccinated or partially vaccinated); (B) attest that they have
lost or are otherwise unable to produce proof required by the standard;
and (C) include the following language: ``I declare (or certify,
verify, or state) that this statement about my vaccination status is
true and accurate. I understand that knowingly providing false
information regarding my vaccination status on this form may subject me
to criminal penalties.'' The note to paragraph (e)(2)(vi) explains that
an employee who attests to their vaccination status should, to the best
of their recollection, include the following information in their
attestation: The type of vaccine administered; date(s) of
administration; and the name of the health care professional(s) or
clinic site(s) administering the vaccine(s). For example, some of the
information may be easier to recall, such as receiving a vaccine at a
mass vaccination site or local pharmacy, while the dates of
administration might only be remembered as falling within a particular
month or months. OSHA understands that employees may not be able to
recall certain information, such as the type of vaccine received.
Employees providing attestations should include as much of this
information as they can remember to the best of their ability.
Any statement provided under paragraph (e)(2)(vi) must include an
attestation that the employee is unable to produce another type of
proof of vaccination (paragraph (e)(2)(vi)(B)). Thus, before an
employee statement will be acceptable for proof of vaccination under
paragraph (e)(2)(vi), the employee must have attempted to secure
alternate forms of documentation via other means (e.g., from the
vaccine administrator or their state health department) and been
unsuccessful in doing so. The agency recognizes that securing
vaccination documentation may be challenging for some members of the
workforce, such as migrant workers, employees who do not have access to
a computer, or employees who may not recall who administered their
vaccines (e.g., if the vaccination was provided at a temporary
location, such as a church, or during a state or local mass vaccination
campaign). Thus, for employees who have no other means of obtaining
proof of vaccination, the standard permits employers to accept
attestations meeting the requirements in paragraph (e)(2)(vi) as proof
of vaccination. However, employers should explain to their employees
that they need to produce vaccination proof through the other means
listed in paragraph (e)(2), such as by contacting the vaccination
administrator, if they are able to do so. Once the employee has
provided a signed and dated attestation that meets the requirements of
paragraph (e)(2)(vi), the employer no longer needs to seek out one of
the other forms of vaccination proof for that employee and, depending
on the content of the attestation, the employer may consider that
employee either fully or partially vaccinated for purposes of the ETS.
Recently, there has been evidence of fraud associated with people
attesting to their vaccination status (Bergal, September 16, 2021).
While employers may not invite or facilitate fraud, the ETS does not
require employers to monitor for or detect fraud. By defining what
constitutes acceptable proof of vaccination under the ETS, OSHA is
ensuring that employers can accept proof meeting the requirements of
paragraph (e) for purposes of compliance with the standard. However,
the standard's requirements for proof of vaccination are integral to
ensuring that employees are protected appropriately, either through
vaccination (the preferred and most effective workplace control in this
ETS), or through regular testing and use of face coverings. Thus, it is
paramount that employees provide truthful information regarding their
vaccination status.
As discussed in more detail in the Summary and Explanation for
paragraph (j) (Section VI.J. of this section), 18 U.S.C. 1001(a), which
provides for fines or imprisonment of generally up to 5 years for any
person who ``in any matter within the
jurisdiction'' of the executive branch U.S. Government ``knowingly and
willfully'' engages in any of the following:
(1) Falsifies, conceals, or covers up by any trick, scheme, or
device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement
or representation; or
(3) makes or uses any false writing or document knowing the same to
contain any materially false, fictitious, or fraudulent statement or
entry.
Similarly, the OSH Act recognizes that OSHA's ability to protect
workers' safety and health hinges on truthful reporting. For that
reason section 17(g) of the OSH Act subjects anyone who ``knowingly
makes any false statement, representation, or certification in any
application, record, report, plan, or other document filed or required
to be maintained pursuant to this chapter'' to criminal penalties. 29
U.S.C. 666(g). False statements made in any proof submitted under
paragraph (e)(2) of the standard could fall under either or both of 18
U.S.C. 1001 or section 17(g) of the OSH Act. And by requiring a
specific declaration about the truth and accuracy of employee
statements provided under paragraph (e)(2)(vi), employees who are
unable to provide any means of proof other than their own attestation
are being made aware that their words are being held to the same
standard of truthfulness as any other record presented for proof of
vaccination.
OSHA notes that these same prohibitions on false statements and
documentation can apply to employers. If an employer knows that proof
submitted by an employee is fraudulent, and even with this knowledge,
accepts and maintains the fraudulent proof as a record of compliance
with this ETS, it may be subject to the penalties in 18 U.S.C. 1001 and
17(g) of the OSH Act.
Paragraph (e)(3) provides the mechanism for employers to determine
vaccination status for employees who do not submit any of the
acceptable forms of proof of vaccination status. Under paragraph
(e)(3), any employee who does not provide their employer with one of
the acceptable forms of proof of vaccination status in paragraph (e)(2)
must be treated as not fully vaccinated for the purpose of the
standard. An unvaccinated employee does not need to provide any
documentation regarding vaccination status under this ETS; however,
failing to provide acceptable proof of vaccination status will signal
the employer to consider the employee as not fully vaccinated and to
note that as their status in the roster. For employers that include
COVID-19 testing in their written policies under paragraph (d),
employees without acceptable proof of vaccination status must submit to
weekly tests (as required by paragraph (g)) and wear a face covering
(as required by paragraph (i)).
Paragraph (e)(4) requires the employer to maintain a record of each
employee's vaccination status and preserve acceptable proof of
vaccination for each employee who is fully or partially vaccinated. As
discussed previously, the employer has various options for acquiring
proof of vaccination from each employee. An employer may allow
employees to provide a digital copy of acceptable records, including,
for example, a digital photograph, scanned image, or PDF of such a
record that clearly and legibly displays the necessary vaccination
information. However, to be in compliance with paragraph (e)(4), the
employer must ensure they are able to maintain a record of each
employee's vaccination status. Therefore, obtaining an employee's
vaccination information verbally would not comply with paragraph (e)(2)
or satisfy the record maintenance requirements of the standard.
Similarly, the record maintenance requirements of paragraph (e)(4)
cannot be fulfilled by an employee merely showing the employer their
vaccination status (e.g., by bringing the CDC COVID-19 vaccination card
to the workplace and showing it to an employer representative or
showing an employer representative a picture of the immunization
records on a personal cellphone). To satisfy paragraph (e)(4), the
employer must retain a copy of the documentation. As mentioned above,
some states and local governments utilize QR codes to facilitate proof
of vaccination. This can be an acceptable form of proof for compliance
with the standard so long as the employer retains a copy of the
information retrieved by scanning the QR code and maintains that
record. Required records of vaccination status can be maintained
physically or electronically, but the employer must ensure they have
access to the records at all times.
In addition to obtaining and maintaining individual records of each
employee's vaccination status and preserving acceptable proof of
vaccination for each employee who is partially or fully vaccinated,
under paragraph (e)(4) the employer must maintain a roster of each
employee's vaccination status, subject to applicable confidentiality
requirements. The roster must list all employees and clearly indicate
for each one whether they are fully vaccinated, partially (not fully)
vaccinated, not fully vaccinated because of a medical or religious
accommodation (see Note to paragraph (d)), or not fully vaccinated
because they have not provided acceptable proof of their vaccination
status. As noted previously, any employee that has not provided
acceptable proof of their vaccination status must be treated as not
fully vaccinated. Although unvaccinated employees will not have proof
of vaccination status, the standard requires the employer to include
all employees, regardless of vaccination status, on the roster.
The roster allows the employer to easily access the vaccination
status for any employee quickly and easily. This will be useful should
the employer need to respond to a request from an employee or employee
representative for the aggregate number of fully vaccinated employees
at a workplace (along with the total number of employees at that
workplace), as required under paragraph (l)(2). Additionally, the
roster will help the employer implement the written policy developed in
accordance with paragraph (d) and comply with other requirements of the
ETS. And finally, the roster, which must be provided to OSHA on request
(paragraph (l)(3)), will aid OSHA's ability to effectively and
efficiently enforce this ETS.
The records and roster required by paragraph (e)(4) are considered
to be employee medical records and must be maintained as such records
in accordance with 29 CFR 1910.1020 and must not be disclosed except as
required or authorized by this ETS or other federal law, including the
Americans with Disabilities Act (ADA), 42 U.S.C. 12101 et seq. These
records and roster are not subject to the retention requirements of 29
CFR 1910.1020(d)(1)(i) but must be maintained and preserved while this
ETS remains in effect. OSHA considers vaccination records required by
paragraphs (e)(2) and (e)(4) of the ETS to be employee medical records
concerning the health status of an employee and is requiring this
personally identifiable medical information to be maintained in a
confidential manner. OSHA notes that under paragraph (e)(4),
vaccination records and rosters are employee medical records, and must
be treated as employee medical records under 29 CFR 1910.1020, without
regard to whether the records satisfy the definition of employee
medical record at 29 CFR 1910.1020(c)(6)(i).
Paragraph (e) in 29 CFR 1910.1020 includes requirements for access
to employee medical records by
employees, their designated representatives, and OSHA. However, as
discussed in more detail below, paragraph (l) of the ETS includes
specific timeframes within which employers must make vaccine records
available to employees, OSHA, and other specified individuals.
Accordingly, the timeframes for providing access to employee medical
records in 29 CFR 1910.1020(e) do not apply, and employers must follow
the specific timeframes set forth in paragraph (l) of the ETS for
providing access to vaccination records.
Additionally, 29 CFR 1910.1020(d) addresses the preservation of
employee exposure and medical records. Paragraph (d)(1)(i) in section
1910.1020 generally provides that unless a specific occupational safety
and health standard provides a different period of time, each employer
must preserve and maintain employee medical records for at least the
duration of employment plus thirty (30) years. Paragraph (e)(4) of the
ETS specifically provides that the vaccination records required by the
ETS are not subject to the retention requirements of 29 CFR
1910.1020(d)(1)(i). Instead, paragraph (e)(4) states that vaccination
records must be maintained and preserved only so long as the ETS
remains in effect.
Finally, while the provisions on timeframes for access to records
and the retention provisions of 29 CFR 1910.1020 do not apply to
vaccine records required by the ETS, other provisions in that
regulation can still apply. For example, 29 CFR 1910.1020(h) includes
requirements for the transfer of employee medical records when an
employer ceases to do business.
OSHA recognizes the possibility that an employer may have already
collected information about the vaccination status of employees,
including proof of vaccination, prior to the effective date of this
ETS. Under paragraph (e)(5), when an employer has ascertained employee
vaccination status prior to the effective date of the ETS through
another form of attestation or proof, and retained records of that
ascertainment, the employer is exempt from the requirements in
paragraphs (e)(1)-(e)(3). The exemption applies only for each employee
whose fully vaccinated status has been documented prior to the
effective date of the standard. For example, an employer may have asked
each employee to self-report their vaccination status without requiring
the employee to provide any form of proof. If that self-reporting was
through oral conversation only, and not documented in some way, the
employer is not considered to have retained records of that
ascertainment for the purposes of this ETS. However, if, for example,
the employer had the employees provide their vaccine information on a
dated form, or through individual emails retained by the employer, or
on an employer portal specifically created for employees to provide
documentation status, or the employer created and retained some other
means of documentation, the employer is considered to have retained
records of ascertainment for the purposes of this ETS. Even if the
record does not have all of the elements of the acceptable forms of
proof listed in paragraph (e)(2), so long as the employer has
ascertained employee vaccination status prior to the effective date of
the ETS through another form of attestation or proof, and retained
records of that ascertainment, the employer does not need to re-
determine vaccination status (paragraph (e)(1)) or obtain proof of
vaccination status (paragraph (e)(2)) for fully vaccinated employees.
For purposes of paragraph (e)(4), the employer's records of vaccination
status for each employee whose fully vaccinated status was previously
documented constitute acceptable proof of vaccination. However, the
employer must still develop a roster of each employee's vaccination
status and include on that roster the employees for whom it had
previously determined and retained records of vaccination status. OSHA
notes that if the employer has not ascertained employee vaccination
status for employees prior to the effective date of the ETS, then all
requirements of paragraph (e) would apply. And all requirements of
paragraph (e) also apply with respect to employees for whom the
employer ascertained only partial vaccination status prior to the
effective date of the ETS.
References
Bergal J. (2021, September 16). Fake Vaccine Card Sales Have
Skyrocketed Since Biden Mandate. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/09/16/fake-vaccine-card-sales-have-skyrocketed-since-biden-mandate. (Bergal, September 16,
2021).
Centers for Disease Control and Prevention (CDC). (2021, October 5).
Getting Your CDC COVID-19 Vaccination Record Card. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccination-card.html.
(CDC, October 5, 2021).
New York State Government. (n.d.) Excelsior Pass and Excelsior Pass
Plus. Retrieved October 4, 2021 from https://covid19vaccine.health.ny.gov/excelsior-pass-and-excelsior-pass-plus.
(New York State Government, n.d., Retrieved October 4, 2021).
State of California. (n.d.) Frequently Asked Questions. Retrieved
October 7, 2021 from https://myvaccinerecord.cdph.ca.gov/faq. (State
of California, n.d., Retrieved October 7, 2021).
F. Employer Support for Employee Vaccination
As discussed in the Summary and Explanation for paragraph (d)
(Section VI.D. of this preamble), as well as in Grave Danger and Need
for the ETS (Sections III.A. and III.B. of this preamble), vaccination
is the single most efficient and effective method for protecting
unvaccinated workers from the grave danger posed by COVID-19. This
emergency temporary standard is therefore designed to strongly
encourage vaccination. As discussed in detail below, paragraph (f)
requires employers to support vaccination by providing employees
reasonable time, including up to four hours of paid time, to receive
each primary vaccination dose, and reasonable time and paid sick leave
to recover from side effects experienced following each primary
vaccination dose. For purposes of the requirements to support
vaccination in paragraph (f), OSHA considers a vaccination series that
meets the criteria in subparagraph (ii) of the definition of ``fully-
vaccinated'' (i.e., a heterologous primary series of such vaccines,
receiving doses of different COVID-19 vaccines as part of one primary
series) to be a primary vaccination series, along with the primary
vaccination described in subparagraph (i) of that definition (see the
Summary and Explanation for paragraph (c), Section VI.C. of this
preamble, for more information on the definition of fully vaccinated).
Removing logistical barriers to obtaining vaccination is essential
to increasing workforce vaccination rates, and one such barrier for
many employees is their lack of time off of work to receive the vaccine
and recover from any potential side effects (SEIU Healthcare, February
8, 2021). Employees' concerns about missing work to obtain and recover
from a COVID-19 vaccination dose are well documented. In a McKinsey
survey, 12% of respondents stated that the time spent away from work to
get vaccinated or due to vaccine side effects was a barrier to
vaccination (Azimi et al., April 9, 2021). In a survey conducted of
unvaccinated adults in April 2021, a fifth of respondents said they
were very or somewhat concerned that they may need to take time off to
go and get the vaccine, and 48% of respondents said that they were very
or somewhat concerned that they might miss work if
the vaccine side effects make them feel sick (KFF, May 6, 2021). Black
and Hispanic adults were particularly worried about the potential time
necessary to receive the vaccine and to recover from vaccine side
effects; 64% of unvaccinated Hispanic adults and 55% of unvaccinated
Black adults expressed concern that they might have to miss work due to
the side effects of a COVID-19 vaccine, and 30% of Hispanic adults and
23% of Black adults were concerned that they might need to take time
off work to get a COVID-19 vaccine (KFF, May 6, 2021; KFF, May 17,
2021). News and journal articles further evince this concern (Roy et
al., December 29, 2020; Cleveland Documenters, 2021; Rosenberg and
Stein, August 18, 2021).
This concern reflects the fact that many workers do not have access
to paid time off to receive vaccination or to recover from side
effects. A KFF survey found that only half of all workers reported that
their employer provided them with paid time off either to get a COVID-
19 vaccine or to recover from any side effects (KFF, June 30, 2021). A
subsequent KFF survey found that only about one-third of workers were
sure that their employer offered them paid time off to get a COVID-19
vaccine and recover from side effects (KFF, September 28, 2021).
Although employee access to paid sick leave is less of a concern for
employers with 100 or more employees, approximately 12% of employees in
these situations do not have paid sick leave (BLS, September 2021) and
in some cases, employees may have already exhausted paid sick leave
they have received and would need additional time from their employers
to recover from vaccine side effects.
The scarcity of paid time off for vaccination and side effect
recovery is particularly acute for certain demographic groups. The June
2021 KFF survey found that only 38% of Black workers reported getting
either paid time off to get a COVID-19 vaccine or to recover from side
effects, and that only 41% of workers with household incomes less than
$40,000 annually had access to such paid time off (KFF, June 30, 2021).
Similarly, the September 2021 KFF survey found that lower-wage workers
were particularly unlikely to report access to paid time off for
vaccination or recovery, with only 23% of workers whose household
incomes was less than $40,000 reporting that they could take paid time
off to get vaccinated, and only 28% of that group reporting that they
could take paid time off to recover from side effects (KFF, September
28, 2021). Lower-wage workers' lack of access to paid time off for
vaccination comports with a different report indicating that, before
the pandemic, about 65% of the lowest-wage workers had no access to
paid sick leave, meaning that any time off for vaccination or recovery
would result in lost wages for those who can least afford those losses
(BLS, September 2021). The need for paid time off to receive
vaccination is also particularly important for workers with
disabilities and workers in rural areas because travel to and from
vaccination sites may take more time or be more logistically difficult
for those populations (National Safety Council, 2021).
Paying workers for the time spent to receive vaccination and to
recover from side effects has proven to be an effective method for
increasing vaccination rates. In June 2021, KFF found that
approximately 75% of employed adults surveyed who received paid time
off to get the vaccine or to recover from side effects had received at
least one dose of the vaccine compared to only 51% of those surveyed
who did not receive paid time off from their employer (KFF, June 30,
2021). KFF also found that employees who are provided paid time off and
are encouraged by their employers to get vaccinated are more likely to
get vaccinated, even after controlling for demographic characteristics
that may impact vaccination uptake (KFF, June 30, 2021). Another KFF
survey found that 28% of unvaccinated respondents who did not want to
get the vaccine as soon as possible said that they would be more likely
to obtain vaccination if their employer gave them paid time off to get
vaccinated and recover from any side effects (KFF, May 6, 2021). KFF
has also found that increasing access to paid leave for vaccination or
recovery from side effects can also help further reduce disparities in
vaccination by age and income (KFF, September 28, 2021).
In a different survey, paid time off for vaccination and the
recovery period post-vaccination was the single most-influential action
for encouraging employee vaccination, with 75% of respondents
indicating that such paid time off would significantly or moderately
increase the likelihood that they would get vaccinated (Azimi et al.,
April 9, 2021). Another survey of nearly 9,000 service workers across
large grocery, retail, food service, pharmacy, and delivery firms,
found that vaccination rates were lower than other frontline workers
who also regularly work in-person and indoors, and when employers
supported and facilitated vaccination, such as through providing paid
time off or paid sick leave for vaccination or for recovery from side
effects, employee vaccination rates were higher than if no support was
provided, and in May 2021, workers with paid sick leave were 15% more
likely to have gotten the vaccine than workers without such leave
(Bellew et al., June 2021).
To address this barrier to vaccination, paragraph (f) requires
employers to support COVID-19 vaccination by providing each employee
with reasonable time, including up to four hours of paid time, to
receive each primary vaccination dose, and reasonable time and paid
sick leave to recover from side effects experienced following any
primary vaccination dose. Providing this time is essential for all
unvaccinated employees who are covered by this rule to ensure that they
can receive primary vaccination dose(s) and recover from side effects
without sacrificing pay or their jobs. In workplaces where employers
implement a mandatory vaccination policy in accordance with paragraph
(d)(1) of this rule, the requirements of paragraph (f) ensure that
employees are able to comply with the mandatory vaccination policy
without concern about missing work to do so. In workplaces where the
employer opts out of implementing a mandatory vaccination policy in
accordance with paragraph (d)(2), the requirements of paragraph (f)
encourage employees to choose vaccination, and ensure that employees
who choose to obtain vaccination, rather than be regularly tested for
COVID-19 and wear a face covering in most situations when they work
near others, are not penalized for making that choice.
Paragraph (f)(1) requires employers to support COVID-19 vaccination
for each employee by providing reasonable time to each employee during
work hours for each of their primary vaccination dose(s), including up
to four hours of paid time, at the employee's regular rate of pay, for
the purposes of vaccination. Reasonable time may include, but is not
limited to, time spent during work hours related to the vaccination
appointment(s), such as registering, completing required paperwork, all
time spent at the vaccination site (e.g., receiving the vaccination
dose, post-vaccination monitoring by the vaccine provider), and time
spent traveling to and from the location for vaccination (including
travel to an off-site location (e.g., a pharmacy), or situations in
which an employee working remotely (e.g., telework) or in an alternate
location must travel to the workplace to receive the vaccine).
Employers are not, however, obligated by this ETS to reimburse
employees for transportation costs (e.g., gas money,
train/bus fare, etc.) incurred to receive the vaccination. This could
include the costs of travel to an off-site vaccination location (e.g.,
a pharmacy) or travel from an alternate work location (e.g., telework)
to the workplace to receive a vaccination dose.
Because employers are required to provide reasonable time for
vaccination during work hours, if an employee chooses to receive a
primary vaccination dose outside of work hours, employers are not
required to grant paid time to the employee for the time spent
receiving the vaccine during non-work hours. However, even if employees
receive a primary vaccination dose outside of work hours, employers
must still afford them reasonable time and paid sick leave to recover
from side effects that they experience during scheduled work time in
accordance with paragraph (f)(2).
An employer may make other efforts to facilitate vaccination of its
employees by, for example, hosting a vaccine clinic at the workplace
(e.g., mobile trailer) or partnering with another entity, such as a
pharmacy or healthcare provider, so that employees can be vaccinated at
the workplace or at an off-site location. If an employer chooses to
make the vaccine available to its employees, it must support full
vaccination (i.e., provide all doses in a primary vaccination, as
applicable), and assure the availability of reasonable time and paid
time to each employee to receive the full primary vaccination, and
reasonable time and paid sick leave to recover from side effects that
they may experience. Any additional costs incurred by the employer to
bring vaccination on-site would be covered by the employer, though such
an approach would likely reduce the amount of paid time needed for
vaccine administration (but not side effects) because of reduced
employee travel time.
Paragraph (f)(1) specifies that the amount of paid time that an
employer is required to provide each employee to receive each primary
vaccination dose is capped at four hours. OSHA has determined that four
hours would provide reasonable time for most employees to get each
vaccination dose. Vaccines are widely available to the public at
clinics, pharmacies, and other locations across the country (see CDC,
October 8, 2021). Providing four hours of paid time to receive each
primary vaccination dose is consistent with OSHA's presumption of the
amount of time needed to receive a vaccination dose in the June 2021
Healthcare ETS (86 FR 32598), and with the U.S. Office of Personnel
Management's guidance to federal government agencies on the use of the
emergency paid leave created for federal employees in the American
Rescue Plan Act of 2021 (Public Law 117-2), which encouraged agencies
to offer up to four hours of administrative leave per dose to cover
time spent getting a vaccine dose, plus additional time if reasonably
necessary, instead of having employees use emergency paid leave (OPM,
April 29, 2021). OSHA expects that most employees will need less than
four hours to receive a vaccination dose.
The maximum of four hours of paid time that employers must provide
under paragraph (f)(1)(ii) for the administration of each primary
vaccination dose cannot be offset by any other leave that the employee
has accrued, such as sick leave or vacation leave. OSHA is concerned
that employees forced to use their sick leave or vacation leave for
vaccination would have a disincentive to gaining the health protection
of vaccination. Employers must pay employees for up to four hours of
time at the employee's regular rate of pay. This may be achieved by
paying for the time to be vaccinated as work hours for up to four
hours. Requiring employers to pay for vaccine administration is
consistent with OSHA's normal approach of requiring employers to bear
the costs of compliance with safety and health standards.
OSHA understands that employees may need much less than four hours
to receive a primary vaccination dose, for example, if vaccinations are
offered on-site. However, OSHA also understands that, in some
circumstances, an employee may need more than four hours to receive a
primary vaccination dose, in which case the additional time, as long as
it is reasonable, would be considered unpaid but protected leave. The
employer cannot terminate the employee if they use a reasonable amount
of time to receive their primary vaccination doses. The employee may
use other leave time that they have available (e.g., sick leave or
vacation time) to cover the additional time needed to receive a
vaccination dose that would otherwise be unpaid.
Paragraph (f)(2) also requires employers to support COVID-19
vaccination for each employee by providing reasonable time and paid
sick leave to recover from side effects experienced following any
primary vaccination dose to each employee for each dose. The paid sick
leave can be in the form of an employee's accrued sick leave, if
available. If the employee does not have available sick leave, leave
must be provided for this purpose.
Although some individuals experience no side effects from COVID-19
vaccination doses, the CDC has identified a range of side effects that
other individuals may experience following a vaccination dose (CDC,
April 2, 2021; CDC, September 30, 2021). Side effects may affect
individuals' ability to engage in daily activities, are typically mild-
to-moderate in severity, and usually go away in a few days. Common side
effects include pain, redness, and swelling at the site of injection,
and systemic side effects throughout the body, including tiredness,
headache, muscle pain, chills, fever, and nausea. Side effects may be
sufficiently severe to require the employee to take sick leave from
work, but will rarely extend beyond a few days. One study found that
``unanticipated paid administrative leave was only required for 4.9%
and 19.79% of individuals after the first and second doses of vaccine,
respectively'' (Levi et al., September 25, 2021). Employees would not
typically be expected to need leave solely to address redness or
swelling at the site of injection, but it is not uncommon for vaccine
recipients to require some recovery time for many of the other side
effects. The CDC notes, however, that cough, shortness of breath, runny
nose, sore throat, or loss of taste or smell are not consistent with
post-vaccination symptoms and instead may be symptoms of COVID-19 or
another infection (CDC, April 2, 2021).
If an employee already has accrued paid sick leave, an employer may
require the employee to use that paid sick leave when recovering from
side effects experienced following a primary vaccination dose.
Additionally, if an employer does not specify between different types
of leave (i.e., employees are granted only one type of leave), the
employer may require employees to use that leave when recovering from
vaccination side effects. If an employer provides employees with
multiple types of leave, such as sick leave and vacation leave, the
employer can only require employees to use the sick leave when
recovering from vaccination side effects. Employers cannot require
employees to use advanced sick leave to cover reasonable time needed to
recover from vaccination side effects under paragraph (f)(2). An
employer may not require an employee to accrue negative paid sick leave
or borrow against future paid sick leave to recover from vaccination
side effects. In other words, the employer cannot require an employee
to go into the negative for paid sick leave if the employee does not
have accrued paid
sick leave when they need to recover from side effects experienced
following a primary vaccination dose. Neither the paid time required to
receive any vaccine dose(s) nor the paid sick leave required to recover
from side effects experienced following any vaccination dose are
retroactive requirements for vaccine dose(s) received prior to the
promulgation of this ETS.
Paragraph (f)(2) requires employers to provide reasonable time and
paid sick leave to employees to recover from side effects experienced
following a primary vaccination dose, but does not specify the amount
of paid sick leave that the employer is required to provide for that
purpose. Employers may set a cap on the amount of paid sick leave
available to employees to recover from any side effects, but the cap
must be reasonable. CDC notes that although some people have no side
effects, side effects, if experienced, should go away in a few days
(CDC, September 30, 2021). Another study found that the average
unanticipated paid administrative leave required by individuals
experiencing side effects was around two days (1.66 days for the first
dose and 1.39 days for the second dose) (Levi et al., September 25,
2021). Generally, OSHA presumes that, if an employer makes available up
to two days of paid sick leave per primary vaccination dose for side
effects, the employer would be in compliance with this requirement.
When setting the cap, an employer would not be expected to account for
the unlikely possibility of the vaccination resulting in a prolonged
illness in the vaccinated employee (e.g., a severe allergic reaction).
OSHA is aware that other federal, state, or local laws, or
collective bargaining agreements, may require employers to provide
employees additional paid time for vaccination and/or paid sick leave
to recover from vaccination side effects. Where such an overlap exists,
the requirements of this standard are satisfied so long as the employer
provides each employee reasonable time and four hours of paid time to
receive each primary vaccination dose, and reasonable time and paid
sick leave to recover from side effects experienced following a primary
vaccination dose.
References
Azimi T et al. (2021, April 9). Getting to work: Employers' role in
COVID-19 vaccination.\1\(Azimi et al., April 9, 2021)
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\1\ Azimi T et al. (2021, April 9). Getting to work: Employers'
role in COVID-19 vaccination. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/getting-to-work-employers-role-in-covid-19-vaccination# (Azimi et al., April 9,
2021)
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Bellew E et al. (2021, June). Half of service sector workers are not
yet vaccinated for COVID-19: What gets in the way? The Shift
Project: Research Brief. https://shift.hks.harvard.edu/wp-content/uploads/2021/06/Vax_Brief_6.28.21-2.pdf. (Bellew et al., June 2021)
Centers for Disease Control and Prevention (CDC). (2021, April 2).
Post-vaccination considerations for workplaces. https://www.cdc.gov/coronavirus/2019-ncov/community/workplaces-businesses/vaccination-considerations-for-workplaces.html. (CDC, April 2, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
30). Possible side effects after getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. (CDC,
September 30, 2021)
Centers for Disease Control and Prevention (CDC). (2021, accessed
October 8). We can do this: Vaccines.gov website. https://www.vaccines.gov/. (CDC, October 8, 2021)
Cleveland Documenters. (2021). Why some Clevelanders are still on
the fence or not getting vaccinated: Voices on the vaccine. The
Cleveland Observer. https://www.freshwatercleveland.com/street-level/VaccineVoice050521.aspx. (Cleveland Documenters, 2021)
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, June 30). KFF COVID-19
Vaccine Monitor: June 2021. https://www.kff.org/report-section/kff-covid-19-vaccine-monitor-june-2021-findings/. (KFF, June 30, 2021)
Kaiser Family Foundation (KFF). (2021, September 28). KFF COVID-19
Vaccine Monitor: September 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2021/.
(KFF, September 28, 2021)
Levi ML et al. (2021, September 25). COVID-19 mRNA vaccination,
reactogenicity, work-related absences and the impact on operating
room staffing: A cross-sectional study. Perioperative Care and
Operating Room Management preprint. https://doi.org/10.1016/j.pcorm.2021.100220. (Levi et al., September 25, 2021)
National Safety Council. (2021). A Year in Review, and What's Next:
COVID-19 Employer Approaches and Worker Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (National Safety
Council, 2021)
Rosenberg E and Stein J. (2021, August 18). America's failure to pay
workers time off undermines vaccine campaign, according to surveys,
policy experts. Washington Post. https://www.washingtonpost.com/us-policy/2021/08/16/paid-leave-covid-vaccine/. (Rosenberg and Stein,
August 18, 2021)
Roy B et al. (2020, December 29). Health Care Workers' Reluctance to
Take the COVID-19 Vaccine: A Consumer-Marketing Approach to
Identifying and Overcoming Hesitancy.NEJM Catalyst. https://catalyst.nejm.org/doi/pdf/10.1056/CAT.20.0676. (Roy et al., December
29, 2020)
SEIU Healthcare. (2021, February 8). Research shows 81% of
healthcare workers willing to take COVID-19 vaccines but personal
financial pressures remain a significant barrier for uptake. https://www.newswire.ca/news-releases/research-shows-81-of-healthcare-workers-willing-to-take-covid-19-vaccines-but-personal-financial-pressures-remain-a-significant-barrier-for-uptake-888810789.html.
(SEIU Healthcare, February 8, 2021)
United States Bureau of Labor Statistics (BLS). (2021, September).
National Compensation Survey: Employee Benefits in the United
States, March 2021. https://www.bls.gov/ncs/ebs/benefits/2021/employee-benefits-in-the-united-states-march-2021.pdf. (BLS,
September, 2021)
United States Office of Personnel Management (OPM). (2021, April
29). American Rescue Plan: COVID-19 Emergency Paid Leave for Federal
Employees. https://chcoc.gov/sites/default/files/Attachment%205%20COVID-19%20Emergency%20Paid%20Leave%20Questions%20and%20Answers_0.pdf.
(OPM, April 29, 2021)
G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
Paragraph (g) of this ETS addresses employers' obligations with
respect to employees who are not fully vaccinated, including the
requirement to ensure unvaccinated employees are tested for COVID-19.
As explained in Need for the ETS (Section III.B. of this preamble),
OSHA strongly prefers that employers implement written mandatory
vaccination policies because that is the most effective and efficient
workplace control available for preventing the spread of COVID-19.
However, this ETS is also necessary to protect workers who remain
unvaccinated through required regular testing, use of face coverings,
and removal of infected employees from the workplace, and to protect
other workers from the greater likelihood that unvaccinated workers may
spread COVID-19 in the workplace. People who are unvaccinated are at
increased risk of becoming infected with COVID-19 and are more likely
to spread the disease when compared to people who
are fully vaccinated (CDC, September 15, 2021). Additionally, people
who are unvaccinated are more likely to experience severe clinical
outcomes if they become infected than people who are vaccinated (Lopez
Bernal et al., July 21, 2021). Therefore, routine COVID-19 testing of
unvaccinated employees is necessary to identify employees with COVID-19
so they can be removed from the workplace to prevent transmission to
other employees and to facilitate early medical intervention for
infected employees when appropriate.
Routine testing of unvaccinated employees is necessary regardless
of whether the unvaccinated employees have symptoms because SARS-CoV-2
infection is often attributable to asymptomatic and/or pre-symptomatic
transmission (i.e., individuals who are not exhibiting symptoms)
(Bender et al., February 18, 2021; Klompas, September 2021; Johansson
et al., January 7, 2021; Byambasuren et al., December 11, 2020).
Although less effective and efficient than vaccination, the CDC has
recognized regularly testing unvaccinated employees for COVID-19 as a
useful tool for identifying asymptomatic and/or pre-symptomatic
infected individuals so that they can be isolated (CDC, May 4, 2021;
CDC, October 7, 2021). In contrast, the CDC recommends that fully
vaccinated employees with no symptoms and no known exposure should be
exempt from routine testing programs (CDC, May 4, 2021). Additional
information about the risks of COVID-19 transmission in vaccinated and
unvaccinated workers is discussed in Grave Danger (Section III.A. of
this preamble).
Testing for COVID-19 can broadly be divided into two categories:
diagnostic testing and screening testing. The purpose of diagnostic
testing is to identify current infection when a person has signs or
symptoms consistent with COVID-19, or when a person is asymptomatic but
has recent known or suspected exposure to SARS-CoV-2. The information
provided by diagnostic testing can be used by a healthcare provider to
diagnose or treat a patient. The purpose of screening testing is to
identify infected people who are asymptomatic and do not have known,
suspected, or reported exposure to COVID-19. Screening testing helps to
identify unknown cases both so that measures can be taken to prevent
further transmission to others (e.g., removal from the workplace and
home isolation) and also to allow infected, but asymptomatic, people to
begin medical treatment, as appropriate, so they can better avoid the
most severe outcomes of COVID-19 (e.g., high risk individuals seeking
monoclonal antibody treatment or anti-viral medication). Although the
testing required in paragraph (g)(1) of this ETS is screening testing,
both screening and diagnostic testing can help prevent the spread of
COVID-19. Paragraph (g) does not preclude additional diagnostic testing
if an employee shows signs or symptoms consistent with COVID-19 or has
recent known or suspected exposure to SARS-CoV-2.
Both screening and diagnostic testing involve the use of viral
COVID-19 tests to detect current infection, as opposed to antibody
COVID-19 tests, which are used to detect whether a person has
antibodies for COVID-19. A positive antibody test indicates someone has
antibodies to SARS-CoV-2, the virus that causes COVID-19, which could
either be the result of a prior infection with the virus or vaccination
against COVID-19 (FDA, May 19, 2021; CDC, September 10, 2021). Viral
tests for current infection fall into two categories: Nucleic acid
amplification tests (NAATs) and antigen tests. The Food and Drug
Administration (FDA) (October 6, 2021) has issued a number of Emergency
Use Authorizations (EUAs) for viral COVID-19 tests. It is important to
note that OSHA's definition of ``COVID-19 test'' requires that COVID-19
tests be cleared, approved, or authorized by the FDA and administered
in accordance with authorized instructions, with the noted exception of
not allowing tests that are both self-administered and self-read by the
employee unless observed by the employer or an authorized telehealth
proctor. In this regard, OSHA recognizes that it is within FDA's
authority and jurisdiction to help to assure the appropriate safety,
efficacy, and accuracy of COVID-19 tests. The definition of ``COVID-19
test'' has previously been discussed in the Summary and Explanation for
paragraph (c) (Section VI.C. of this preamble). Additional information
about the type of COVID-19 tests that would satisfy the requirements of
paragraph (g) are available in that section of this preamble.
As explained above, the most effective and efficient workplace
control for preventing the spread of COVID-19 is vaccination and OSHA
strongly prefers that employers implement written mandatory vaccination
policies. However, where employers have unvaccinated employees, regular
COVID-19 screening tests are necessary so infected employees can be
identified and removed from the workplace to prevent workplace
transmission and to facilitate early medical intervention, when
appropriate. In addition to being more likely to become infected with
COVID-19, people who are unvaccinated are more likely to experience
severe clinical outcomes from COVID-19 than fully vaccinated people
(see Grave Danger, Section III.A. of this preamble). In a recent CDC
Morbidity and Mortality Weekly Report (MMWR) out of Los Angeles County,
the SARS-CoV-2 infection rate among unvaccinated persons was 4.9 times
and the hospitalization rate was 29.2 times the rates among fully
vaccinated persons (Griffin et al., August 27, 2021). As explained
below, regular screening testing of individuals for COVID-19 is an
effective method of identifying asymptomatic and pre-symptomatic
infections. Screening testing of unvaccinated employees is necessary
because symptom and temperature checks will miss both asymptomatic and
pre-symptomatic infections, which is a serious problem because pre-
symptomatic and asymptomatic transmission are significant drivers of
the continued spread of COVID-19 (Johansson et al., January 7, 2021).
Once infected employees are identified, they can be removed from the
workplace, thereby reducing virus transmission to other employees.
Several studies have indicated that the time from exposure to
becoming contagious for COVID-19 is shorter than the time for symptoms
to develop (incubation period), meaning that individuals can transmit
SARS-CoV-2 before they begin to feel ill (i.e., pre-symptomatic
transmission) (Nishiura et al., March 4, 2020; Tindale et al., June 22,
2020). Pre-symptomatic individuals can transmit the virus to others
before they know they are sick. These individuals should isolate but
would not know to do so if they are unaware of their infection. It is
also possible for individuals to be infected and subsequently transmit
the virus without ever exhibiting symptoms. This is called asymptomatic
transmission. A meta-analysis of 351 studies from January 1, 2020, to
April 2, 2021, estimated that 42.8% of those infected with the SARS-
CoV-2 virus exhibited no symptoms at the time of testing and so had
either asymptomatic or pre-symptomatic infections (Sah et al., August
10, 2021). In another meta-analysis of studies, which included people
of all ages at risk of contracting COVID-19 who were tested regardless
of presence or absence of symptoms, seventeen percent of cases never
developed symptoms during entire COVID-19 infection (i.e., asymptomatic
infection). In those studies, a diagnosis was confirmed with
a positive result on a RT-PCR and all positive cases had a follow-up
period of at least seven days to distinguish asymptomatic cases from
pre-symptomatic cases (Byambasuren et al., December 11, 2020). In
another study, researchers used a decision analytical model to assess
the proportion of SARS-CoV-2 transmission from pre-symptomatic, never
symptomatic, and symptomatic individuals in the community. Based on
their modeling, they predicted that 59% of transmission came from
asymptomatic transmission, including 35% from pre-symptomatic
individuals and 24% from individuals who never develop symptoms
(Johansson et al., January 7, 2021).
The existence of pre-symptomatic and asymptomatic infections pose
serious challenges to containing the spread of SARS-CoV-2. Although the
risk of asymptomatic transmission is 42% lower than from symptomatic
COVID-19 patients (Byambasuren et al., December 11, 2020), asymptomatic
transmission may result in more transmissions than symptomatic cases
because asymptomatic persons are less likely to be aware of their
infection and can unknowingly continue to spread the disease to others
(Sah et al., August 10, 2021). The challenge of containing pre-
symptomatic and asymptomatic SARS-CoV-2 transmission is amplified among
unvaccinated individuals because, as explained above, they are more
likely to become infected with COVID-19 in the first place.
Because unvaccinated employees are at higher risk of COVID-19
infection and COVID-19 transmission among individuals without symptoms
is a significant driver of the spread of COVID-19, OSHA has determined
it is necessary to prevent the pre-symptomatic and asymptomatic
transmission of COVID-19 from unvaccinated workers, through a
requirement for weekly screening testing. Screening testing with
antigen tests is a rapidly evolving and important tool that can be used
to reduce the spread of SARS-CoV-2 in the workplace, particularly when
coupled with other COVID-19 prevention and control measures (e.g.,
workplace removal of infected persons, proper use of face coverings)
(Schulte et al., May 19, 2021). The CDC recommends screening testing of
unvaccinated asymptomatic workers as a useful tool to detect COVID-19
and stop transmission quickly. Screening testing is particularly useful
in areas with moderate to high community transmission of COVID-19,
which is currently the overwhelming majority of the United States (CDC,
October 7, 2021). In a study with a well-defined population of SARS-
CoV-2 infected individuals, researchers found that frequent testing
(i.e., at least twice per week) maximizes the likelihood of detecting
infected individuals. However, even when used weekly, rapid antigen
tests still had a 76% probability of detection (i.e., weekly rapid
antigen tests correctly identified 76% of true positive infected COVID-
19 individuals) (Smith et al., September 15, 2021). By identifying pre-
symptomatic and asymptomatic unvaccinated employees, employers can
remove them from the workplace to prevent those employees from
spreading SARS-CoV-2 to other employees. More information about the
removal requirements in this ETS is available in the Summary and
Explanation for paragraph (h) (Section VI.H. of this preamble).
Since the incubation period for COVID-19 can be up to 14 days, the
CDC recommends that screening testing be conducted at least weekly in
non-healthcare workplaces (CDC, October 7, 2021; CDC, May 4, 2021).
Other researchers also recognize the effectiveness of weekly screening
testing to control surges of COVID-19 infections (Larremore, January 1,
2021). Consequently, in workplaces with unvaccinated employees, OSHA
has set the minimum frequency of testing unvaccinated workers at seven
days because the agency expects that it will be effective in slowing
the spread of COVID-19 in those workplaces, when used in tandem with
face coverings (paragraph (i)) and removal of infected individuals
(paragraph (h)). OSHA emphasizes that each of these infection controls
provides some protection from COVID-19 by itself, but that they work
best when used together, layering their protective impact to boost
overall effectiveness. Although some studies have shown that more
regular screening testing (e.g., twice weekly) would identify even more
cases, OSHA has decided to require testing only on a weekly basis. This
is in line with the CDC recommendations, and as noted above the
evidence shows that this frequency is effective in detecting
asymptomatic and pre-symptomatic cases. A more frequent testing
schedule would result in significant additional costs, and OSHA is
hesitant to impose these costs and depart from CDC recommendations
without a fuller record generated through the benefit of notice and
comment rulemaking. OSHA seeks comment on this issue. Nonetheless, it
should be noted that nothing in this rule prevents screening testing
from being conducted more frequently based on factors such as the level
of community transmission, workplace experience with outbreaks, and
type of workplace (e.g., specific workplace factors such as high volume
retail or critical infrastructure sector).
Early detection of COVID-19-positive employees through screening
testing of unvaccinated employees also facilitates early medical
intervention, when appropriate, to avoid the most severe health
outcomes associated with COVID-19. Early effective treatment of disease
can help avert progression to more serious illness, especially for
patients at high risk of disease progression and severe illness, with
the additional benefit of reducing the burden on healthcare systems
(CDC, December 4, 2021). For example, anti-SARS-CoV-2 monoclonal
antibodies have been shown to reduce the risk of hospitalization and
death in the outpatient setting in those with mild to moderate COVID-19
symptoms and certain risk factors for disease progression. Treatment
should be started as soon as possible after the patient receives a
positive result on a COVID-19 test and within 10 days of symptom onset
(NIH, September 24, 2021). Any COVID-19 medical treatment should be
used in accordance with a licensed healthcare provider. The screening
tests required by this rule will facilitate such treatment.
Pursuant to paragraph (g)(1)(i), covered employers must ensure that
each employee who is not fully vaccinated and reports at least once
every seven days to a workplace where other individuals (e.g.,
coworkers, customers) are present: (A) Is tested for COVID-19 at least
once every seven days; and (B) provides documentation of the most
recent COVID-19 test result to the employer no later than the 7th day
following the date on which the employee last provided a test result.
Employers must ensure these unvaccinated employees are tested at least
once every seven calendar days, regardless of their work schedule. For
example, an unvaccinated part-time employee who is scheduled to work
only every Monday and Tuesday must still be tested at least once every
seven days. Because employees must provide documentation of their most
recent COVID-19 test results to their employers no later than the 7th
day following the date on which they last provided a test result,
employees may want to set a schedule for their testing (e.g., get a
COVID-19 test every Wednesday). A consistent testing day may help
employees ensure their documentation is provided every seven calendar
days.
Paragraph (g)(1)(ii) addresses situations where an employee does
not report to a workplace where other individuals, such as coworkers or
customers, are present during a period of seven or more days (e.g.,
when an employee is teleworking for an extended period of time). In
such cases, the employer must ensure the employee is tested for COVID-
19 within seven days prior to returning to the workplace and provides
documentation of that test result to the employer upon return to the
workplace. For example, if an unvaccinated office employee has been
teleworking for two weeks but must report to the office, where other
employees will be present (e.g., coworkers, security officers, mailroom
workers), on a specific Monday to copy and fax documents, that employee
must receive a COVID-19 test within the seven days prior to the Monday
and provide documentation of that test result to the employer upon
return to the workplace. The employee's test must occur within the
seven days before the Monday the employee is scheduled to report to the
office, but it also must happen early enough to allow time for the
results to be received before returning to the workplace. Similarly,
unvaccinated new hires would need to be tested for COVID-19 within
seven days prior to reporting to a workplace where other employees will
be present and provide documentation of their test results no later
than arrival on their first day of work. Since point-of-care testing
that uses an antigen test allows for results within minutes, OSHA does
not expect that scheduling tests or providing results to employers will
be an impediment.
OSHA chose the seven-day period for employees returning to work
after more than a week away from the workplace based on the evidence
noted above about the effectiveness of testing at seven-day intervals.
While it considered using a shorter time period in this situation, OSHA
concluded that it would be less confusing for employers to use a
uniform time period for both situations. OSHA was concerned that
requiring different time periods in the two situations would cause
confusion among both employees and supervisors implementing the program
that would undermine the effectiveness of the testing scheme. OSHA
seeks comment on this issue.
An employer has some discretion regarding how to satisfy its
obligations under paragraph (g)(1), but those policies and procedures
must be detailed in the employer's written policy pursuant to paragraph
(d)(2) of this ETS. For example, the employer must specify how testing
will be conducted (e.g., testing provided by the employer at the
workplace, employees independently scheduling tests at point-of-care
locations, etc.). The employer must also specify in their policy how
employees should provide their COVID-19 test results to the employer
(e.g., an online portal, to the human resources department). The
Summary and Explanation for paragraph (d) (Section VI.D. of this
preamble) provides additional information regarding the requirements of
paragraph (d)(2) of this ETS. Test results given to the employer must
contain information that identifies the worker (i.e., full name plus at
least one other identifier, such as date of birth), the specimen
collection date, the type of test, the entity issuing the result (e.g.,
laboratory, healthcare entity), and the test result.
If an employer is notified that an employee has a positive
screening test, the employer must remove that employee from the
workplace pursuant to paragraph (h)(2) of this ETS. The employee should
quarantine and the employer must not allow the employee to return to
the workplace until they meet the requirements in paragraphs (h)(2)(i)
through (iii). More discussion of employee notification to their
employer of a COVID-19 positive status and removal requirements is
available in the Summary and Explanation for paragraph (h) (Section
VI.H. of this preamble).
OSHA expects that most screening testing will be antigen testing
that is conducted at point-of-care locations due to the reduced cost
and faster processing time when compared to NAAT testing in
laboratories. Most NAATs need to be processed in a laboratory with
variable time to results (approximately 1-2 days). In contrast, most
antigen tests can be processed at the point of care with results
available in about 15-30 minutes (CDC, October 7, 2021). Rapid point-
of-care tests are administered in various settings, such as: Physician
offices, urgent care facilities, pharmacies, school health clinics,
workplace health clinics, long-term care facilities and nursing homes,
and at temporary locations, such as drive-through sites managed by
local organizations. As explained above, COVID-19 tests that are both
self-administered and self-read do not meet the definition of ``COVID-
19 test'' in this ETS (unless observed by the employer or an authorized
telehealth proctor) and therefore do not satisfy the testing
requirements of paragraph (g).
Because antigen testing in point-of-care locations will typically
produce results within minutes, the use of antigen testing should not
result in an inability to provide the employer with test results in a
timely fashion. However, the agency recognizes that where the employee
or employer uses an off-site laboratory for testing, there may be
delays beyond the employee's or employer's control. In the event that
there is a delay in the laboratory reporting results and the employer
permits the employee to continue working, OSHA will look at the pattern
and practice of the individual employee or the employer's testing
verification process and consider refraining from enforcement where the
facts show good faith in attempting to comply with the standard.
OSHA has determined that employers may use pooling procedures to
satisfy the requirements of screening testing under paragraph (g)(1).
Pooling (also referred to as pool testing or pooled testing) means
combining the same type of specimen from several people and conducting
one laboratory test on the combined pool of specimens to detect SARS-
CoV-2 (e.g., four samples may be tested together, using only the
resources needed for a single test). The advantages of pooling include
preserving testing resources, reducing the amount of time required to
test large numbers of specimens (increasing throughput), and lowering
the overall cost of testing (CDC, June 30, 2021).
If pooling procedures are used and a pooled test result comes back
negative, then all the specimens can be presumed negative with the
single test. In other words, all of the employees who provided
specimens for that pool test can be assumed to have a negative test
result for SARS-CoV-2 infection. Therefore, documentation of the
negative pooled test result would satisfy the paragraph (g)(1)
documentation requirement for each employee in the pool and no
additional testing is necessary. However, if the pooled test result is
positive, immediate additional testing would be necessary to determine
which employees are positive or negative. Each of the original
specimens collected in the pool must be tested individually to
determine which specimen(s) is (are) positive. If original specimens
from the workers in a pooled test with a positive result are
insufficient to be subsequently tested individually, those workers in
the positive pool would need to be immediately re-swabbed and tested.
The individual employee test results would be necessary to satisfy the
employee documentation requirements of paragraph (g)(1). Where pooled
testing is used (in accordance with paragraph (g)(1)), CDC and FDA
procedures and
recommendations for implementing screening pooled tests should be
followed (CDC, June 30, 2021; FDA, August 24, 2020). OSHA notes that
only some tests are authorized for pooled testing, and should be
performed per the authorization.
In a note to paragraph (g)(1), OSHA explains that this section does
not require the employer to pay for any costs associated with testing.
As explained in Pertinent Legal Authority, Section II. of this
preamble, the OSH Act authorizes OSHA to require employers to bear the
costs of compliance with occupational safety and health standards, but
OSHA has discretion to decide whether to impose certain costs--such as
those related to medical examinations or other tests--on employers
``[w]here [it determines that such costs are] appropriate.'' 29 U.S.C.
655(b)(7). OSHA has commonly required employers to bear the costs of
compliance with standards as a cost of doing business, including
requiring employers to bear the costs of medical examinations and
procedures (see, e.g., 29 CFR 1910.1018(n)(1)(i) (inorganic arsenic
standard requires employers to ensure that medical examinations and
procedures are provided ``without cost to the employee''); see also
United Steelworkers, 647 F.2d at 1229-31 (discussing Lead standard's
medical removal provisions and OSHA's authority for imposing cost of
medical removal on employers)). Requiring employers to bear the costs
of compliance makes it more likely that employees will take advantage
of workplace protections (see 86 FR 32605). For example, employees are
more likely to use personal protective equipment (PPE) when employers
provide the PPE to their employees at no cost (see 72 FR 64342, 64344).
In this ETS, OSHA has largely required employers to bear the costs
of compliance, including the typical costs associated with vaccination,
but has determined that it would not be appropriate to impose on
employers any costs associated with COVID-19 testing for employees who
choose not to be vaccinated. As explained in Need for the ETS, Section
III.B. of this preamble, this ETS is designed to strongly encourage
vaccination because vaccination is the most efficient and effective
control for protecting unvaccinated workers from the grave danger posed
by COVID-19. COVID-19 testing is only required under the ETS where an
employee has made an individual choice to forgo vaccination and pursue
a less protective option. Given the superior protectiveness of
vaccination, and OSHA's intent for this ETS to strongly encourage
vaccination, requiring employers to bear the costs of COVID-19 testing
would be counter-productive. As mentioned above, requiring employers to
pay for workplace protections makes it more likely that employees will
take advantage of that protection, and in this ETS, OSHA intends to
strongly encourage employees to choose vaccination, not regular COVID-
19 testing. Because employees who choose to remain unvaccinated will
generally be required to pay for their own COVID-19 testing, this
standard creates a financial incentive for those employees to become
fully vaccinated and avoid that cost.
Although this ETS does not require employers to pay for testing,
employer payment for testing may be required by other laws,
regulations, or collective bargaining agreements or other collectively
negotiated agreements. This section also does not prohibit the employer
from paying for costs associated with testing required by paragraph
(g)(1) of this section. Otherwise, the agency leaves the decision
regarding who pays for the testing to the employer. Because OSHA does
not specify who pays for the testing, OSHA expects that some workers
and/or their representatives will negotiate the terms of payment. OSHA
has also considered that some employers may choose to pay for some or
all of the costs of testing as an inducement to keep employees in a
tight labor market. Other employers may choose to put the full cost of
testing on employees in recognition of the employee's decision not to
become fully vaccinated. It is also possible that some employers may be
required to cover the cost of testing for employees pursuant to other
laws or regulations. OSHA notes, for instance, that in certain
circumstances, the employer may be required, under the Fair Labor
Standards Act, to pay for the time it takes an employee to be tested
(e.g., if employee testing is conducted in the middle of a work shift).
The subject of payment for the costs associated with testing pursuant
to other laws or regulations not associated with the OSH Act is beyond
OSHA's authority and jurisdiction. As explained in a note to paragraph
(d) of this ETS, under various anti-discrimination laws, workers who
cannot be tested because of a sincerely held religious belief may ask
for a reasonable accommodation from their employer. For more
information about evaluating requests for reasonable accommodation for
a sincerely held religious belief, employers should consult the Equal
Employment Opportunity Commission's website: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
Pursuant to paragraph (g)(2), if an employee does not provide the
result of a COVID-19 test as required by paragraph (g)(1), the employer
must keep the employee removed from the workplace until the employee
provides a test result. This provision is imperative because workers
with asymptomatic or pre-symptomatic SARS-CoV-2 infection are
significant contributors to COVID-19 transmission, and screening
testing will help to identify and remove those individuals from the
workplace. Employees providing accurate and weekly test results to
their employer is of utmost importance for preventing and reducing the
transmission of COVID-19 in the workplace.
Paragraph (g)(3) provides that when an employee has received a
positive COVID-19 test, or has been diagnosed with COVID-19 by a
licensed healthcare provider, the employer must not require that
employee to undergo COVID-19 testing for 90 days following the date of
their positive test or diagnosis. This provision is specifically
intended to prohibit screening testing for 90 days because of the high
likelihood of false positive results that do not indicate active
infection but are rather a reflection of past infection. Studies of
patients who were hospitalized and recovered indicate that SARS-CoV-2
RNA can be detected in upper respiratory tract specimens for up to
three months (90 days) after symptom onset (CDC, August 2, 2021; CDC,
September 14, 2021). If employees were to be subjected to screening
tests in such a situation it would both undermine the confidence in the
COVID-19 screening tests and could result in a harm to the worker of
being unnecessarily removed from the workplace and subjected to the
additional burden of unnecessary tests. Where employers implement a
vaccination policy that allows employees to choose to provide proof of
regular testing and wear a face covering rather than getting
vaccinated, the employer's policy and procedures to implement this
temporary suspension of testing must be included in their written
workplace policy as required by paragraph (d)(2) of this ETS.
Paragraph (g)(4) provides that the employer must maintain a record
of each test result required to be provided by each employee under
paragraph (g)(1) of this ETS or obtained during tests conducted by the
employer. These records must be maintained in
accordance with 29 CFR 1910.1020 as an employee medical record and must
not be disclosed except as required by this ETS or other federal law.
However, these records are not subject to the retention requirements of
29 CFR 1910.1020(d)(1)(i) (Employee medical records), but must be
maintained and preserved while this ETS remains in effect.
Additionally, paragraph (l) of this ETS includes specific
timeframes for providing access to records, including the COVID-19 test
results required by paragraph (g)(1). As a result, the timeframes for
providing access to employee medical records in 29 CFR 1910.1020(e) do
not apply. Instead, when providing access to an employee, anyone with
written authorized consent from that employee, and OSHA, employers must
follow the access timeframes set forth in paragraph (l) of this ETS.
The Summary and Explanation for paragraph (l) (Section VI.L. of this
preamble) contains additional information about accessing records
gathered pursuant to paragraph (g)(1).
Finally, while the access timeframes in 29 CFR 1910.1020(e) and
retention requirements of 29 CFR 1910.1020(d)(1)(i) do not apply to
test result records required by this ETS, the other provisions in 29
CFR 1910.1020 do apply. For example, 29 CFR 1910.1020(h) includes
requirements for the transfer of employee medical records when an
employer ceases to do business. Like the vaccine records required by
paragraph (e)(4) of this ETS, and because they concern the health
status of an employee, test result records required by paragraph (g)(1)
are employee medical records for purposes of 29 CFR 1910.1020. These
test result records contain personally identifiable medical information
and must be maintained in a confidential manner. The Summary and
Explanation for paragraph (e) (Section VI.E. of this preamble) contains
additional information about the interplay between this ETS and OSHA's
regulation at 29 CFR 1910.1020.
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Griffin JB et al. (2021, August 27). SARS-CoV-2 infections and
hospitalizations among persons aged >=16 years, by vaccination
status--Los Angeles County, California, May 1-July 25, 2021. MMWR
70: 1170-1176. http://dx.doi.org/10.15585/mmwr.mm7034e5. (Griffin et
al., August 27, 2021).
Johansson MA et al. (2021, January 7). SARS-CoV-2 transmission from
people without COVID-19 symptoms. JAMA Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.2020.35057. (Johansson et al., January
7, 2021).
Klompas M et al., (2021, September). The case for mandating COVID-19
vaccines for health care workers. Annals of Internal Medicine.
https://doi.org/10.7326/M21-2366. (Klompas et al., September 2021).
Larremore DB et al. (2021, January 1). Test sensitivity is secondary
to frequency and turnaround time for COVID-19 screening. Sci Adv
2021; 7(1): eabd5393. https://doi.org/10.1126/sciadv.abd5393.
(Larremore, January 1, 2021).
Lopez Bernal et al. (2021, July 21). Effectiveness of COVID-19
vaccines against the B.1.617.2 (Delta) variant. The New England
Journal of Medicine, 385(7), 585-594. https://doi.org/10.1056/NEJMoa2108891. (Lopez Bernal, July 21, 2021).
National Institutes of Health (NIH). (2021, September 24).
Therapeutic Management of Nonhospitalized Adults With COVID-19.
https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/. (NIH,
September 24, 2021).
Nishiura H et al. (2020, March 4). Serial interval of novel
coronavirus (COVID-19) infections. Int J Infect Dis. 2020 Apr; 93:
284-286. doi:10.1016/j.ijid.2020.02.060. Epub 2020 Mar 4. PMID:
32145466; PMCID: PMC7128842. (Nishiura et al., March 4, 2020).
Sah P et al. (2021, August 10). Asymptomatic SARS-COV-2 infection: A
systematic review and meta-analysis. Proceedings of the National
Academy of Sciences, 118(34), 1-12. https://doi.org/10.1073/pnas.2109229118. (Sah et al., August 10, 2021).
Schulte P et al. (2021, May 19). Proposed Framework for Considering
SARS-CoV-2 Antigen Testing of Unexposed Asymptomatic Workers in
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Smith R et al. (2021, September 15). Longitudinal assessment of
diagnostic test performance over the course of acute SARS-CoV-2
infection. The Journal of Infectious Diseases; 224(6), 976-982.
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Tindale LC et al. (2020, June 22). Evidence for transmission of
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2020).
H. Employee Notification to Employer of a Positive COVID-19 Test and
Removal
Employers can substantially reduce disease transmission in the
workplace by removing employees who are confirmed to have COVID-19
based on a COVID-19 test or diagnosis by a healthcare provider. It is
necessary that employees who are confirmed to have COVID-19 be removed
from the workplace to prevent transmission to other employees. Several
studies have focused on the impact of isolating persons with COVID-19
from others during their likely known infectious period, and those
studies show that isolation is a strategy that reduces the transmission
of infections. For example, Kucharski et al. (2020) found that
transmission of SARS-CoV-2 would decrease by 29% with self-isolation
within the household, which would extend to 37% if the entire household
quarantined. Similarly, Wells et al. (2021) found that isolation of
individuals at symptom onset would decrease the reproductive rate (R0)
of COVID-19 from 2.5 to 1.6. Lastly, Moghadas et al. (2020) reported
results that highlight the role of silent transmission, from a
combination of the pre-symptomatic stage and asymptomatic infections,
as the primary driver of COVID-19 outbreaks and underscore the need for
mitigation strategies, including those that detect and isolate
infectious individuals prior to the onset of symptoms. Isolating
contagious employees from their co-workers can prevent further spread
at the workplace and safeguard the health of other employees.
Paragraph (h) provides that employers must require each employee to
promptly notify the employer when the employee receives a positive
COVID-19 test or is diagnosed with COVID-19 by a licensed healthcare
provider. This notification must occur regardless of employee
vaccination status. As discussed in Grave Danger (Section III.A. of
this preamble), exposure to SARS-CoV-2 in the workplace presents a
grave danger to employees; removing those who are confirmed to have
COVID-19 from the workplace mitigates that grave danger. This is true
even for fully vaccinated employees since they also have the potential
to transmit COVID-19 to other individuals, including other employees.
Because the goal of this ETS, and the notification requirements in this
paragraph, is to reduce transmission of COVID-19 in the workplace,
employees are required to notify the employer of any COVID-19 positive
test or diagnosis that they receive, not just positive results that are
received from testing required under paragraph (g) of this ETS.
Paragraph (h)(1) states that the employer must require each
employee who is COVID-19 positive to notify the employer of their
COVID-19 test result or diagnosis ``promptly.'' For employees who are
not at the workplace when they receive a positive COVID-19 test result
or diagnosis, ``promptly'' notifying the employer means notifying the
employer as soon as practicable before the employee is scheduled to
start their shift or return to work. In the event that the employee is
in the workplace when they receive a positive COVID-19 test result or
diagnosis of COVID-19, ``promptly'' notifying the employer means
notifying the employer as soon as safely possible while avoiding
exposing any other individuals in the workplace.
The employer should establish notification procedures and inform
employees about these procedures (see paragraph (j)(1)), so that
employees are aware of the appropriate method for providing this
notification to their employer. These notification procedures can be
based on the employer's current protocols for employees to notify the
employer if they are not able to come to work or need to leave work
because of illness or injury. However the employer chooses to implement
its notification procedures, it must ensure that an employee
notification of a positive COVID-19 test or diagnoses results in the
employee's immediate removal from the workplace, as required under
paragraph (h)(2). For example, the employer may require employees to
report any positive COVID-19 test or diagnosis to a company supervisor
with the authority to temporarily remove the employee from the
workplace. If an employer takes all steps required under this paragraph
but an employee fails to report required information, the ETS does not
dictate that any disciplinary action be taken against the employee. If
an employer is cited by OSHA under this provision under such
circumstances, the employer is entitled to contest the citation if it
can establish an employee misconduct defense in accordance with
applicable case law.
The notification requirement in paragraph (h)(1) is an important
measure to ensure employers can take adequate steps to protect their
employees from the hazard of COVID-19 because it is connected to a
parallel requirement in paragraph (h)(2) to remove, from the workplace,
any employee who receives a positive COVID-19 test or is diagnosed with
COVID-19. It is important to remove employees who test positive or are
diagnosed with COVID-19 from the workplace as soon as possible to
prevent the transmission of COVID-19 to other employees. Therefore, the
requirement that employees promptly inform their employer of a positive
COVID-19 test result or COVID-19 diagnosis is necessary because this
information allows the employer to take actions to protect other
employees, including most critically by removing employees whose
illness poses a direct threat of infection to other employees in the
workplace.
Paragraph (h)(2) requires employers to immediately remove from the
workplace any employee, regardless of vaccination status, who receives
a positive COVID-19 test or is diagnosed with COVID-19 by a licensed
healthcare provider. OSHA determined that directing an employee who
tests positive or is diagnosed with COVID-19 to stay home until return
to work criteria are achieved is critical to preventing the
transmission of COVID-19 in the workplace. Similar to the notification
required in paragraph (h)(1), this removal must occur regardless of
employee vaccination status since someone who is fully vaccinated can
still transmit COVID-19 to others, including other employees (see Grave
Danger, Section III.A. of this preamble).
OSHA notes that, in most circumstances, any positive COVID-19 test
would result in removal. However, this is not necessarily the case
where an employer uses pooled COVID-19 testing, a method where one
laboratory test is conducted using the specimens of several people to
detect the virus that causes COVID-19 (CDC, June 30, 2021). If an
employer conducts pooled testing for COVID-19, a positive pooled test
result would trigger a need to immediately re-test those employees in
the pool using an individual COVID-19 test because the positive pooled
result would not satisfy the requirements of paragraph (g). Only those
employees who test positive on their individual re-test would need to
be removed from the workplace.
OSHA intends ``removal'' under paragraph (h)(2) to refer only to
the temporary removal from the workplace of an employee while that
employee is infectious. The requirement in paragraph (h)(2) to
temporarily remove a COVID-19 positive employee from the workplace does
not mean permanent removal of an employee from their position. Any time
an employee is
required to be removed from the workplace under paragraph (h)(2) of
this section, the employer can require the employee to work remotely or
in isolation if suitable work is available and if the employee is not
too ill to work. In cases where working remotely or in isolation is not
possible, OSHA encourages employers to consider flexible and creative
solutions, such as a temporary reassignment to a different position
that can be performed by telework. However, if an employee is too ill
to work, remote work should not be required, and sick leave or other
leave should be made available as consistent with the employer's
general policies and practices, and as may be required under applicable
laws.
After an employee has been removed from the workplace as required
by paragraph (h)(2), the employer must ensure that they do not return
to the workplace until the employee meets one of three criteria
outlined in paragraphs (h)(2)(i) through (h)(2)(iii). The purpose of
these provisions is to ensure that an employee who has COVID-19 does
not return to work until the risk that they will transmit the disease
to others in the workplace has been minimized. Each of these provisions
is based on the best scientific evidence available on when a person
with COVID-19 is no longer likely to transmit the virus.
Under paragraph (h)(2)(i), the employee can return to work if they
receive a negative result on a COVID-19 nucleic acid amplification test
(NAAT) following a positive result on a COVID-19 antigen test (the most
common screening test). There is a small possibility for employees to
receive false positive test results when conducting regular screening
with an antigen test. Positive results are usually highly accurate at
moderate-to-high peak viral load, but false positives can occur,
depending on the course of infection (FDA, April 2021). OSHA recognizes
that an employee might choose to seek a NAAT test for confirmatory
testing. NAATs are considered the ``gold standard'' for clinical
diagnosis of SARS-CoV-2 and may have a higher sensitivity (i.e.,
ability to correctly generate a positive result) than antigen tests
(CDC, September 9, 2021). If an employee tested positive for COVID-19
via an antigen test, but then received follow-up confirmatory testing
via a NAAT and the NAAT was negative, the positive antigen test can be
considered a false positive and the employee can return to work (CDC,
September 9, 2021). For a more detailed discussion of COVID-19 tests,
see the Summary and Explanation for paragraph (c) (Section VI.C. of
this preamble).
The employee may also return to work if they meet the return to
work criteria in CDC's ``Isolation Guidance'' (incorporated by
reference, Sec. 1910.509) (CDC, February 18, 2021) as described in
paragraph (h)(2)(ii). CDC's guidance states that a COVID-19 positive
person can stop isolating when three criteria are met: (1) At least ten
days have passed since the first appearance of the person's symptoms;
(2) the person has gone at least 24 hours without a fever (without the
use of fever-reducing medication); and (3) the person's other symptoms
of COVID-19 are improving (excluding loss of taste and smell). If a
person has tested positive but never experiences symptoms, then the
person can stop isolating after ten days from the date of their
positive test. These recommendations are based on scientific evidence
reviewed by CDC, which indicates that levels of viral RNA in upper
respiratory tract samples begin decreasing after the onset of symptoms
(CDC, September 14, 2021). The rationale for including CDC's
``Isolation Guidance'' in the ETS was addressed in detail in Need for
Specific Provisions in the agency's prior rulemaking on 1910.502 (see
86 FR 32376, 32455).
Finally, the employee may return to work, per paragraph
(h)(2)(iii), if the employee receives a return-to-work recommendation
from a licensed healthcare provider. The appropriate duration of
removal from work for any given individual may differ depending on
factors such as disease severity or the health of the employee's immune
system. For this reason, the ETS permits employers to make decisions
about an employee's return to work in accordance with guidance from a
licensed healthcare provider (who would be better acquainted with a
particular employee's condition). If a licensed healthcare provider
recommends a longer period of isolation for a particular employee than
the CDC's ``Isolation Guidance'' would otherwise recommend, then the
employer would need to abide by that longer period rather than
returning the employee to work after ten days.
OSHA's removal requirements as outlined in paragraph (h)(2) are
intended to set the floor for what is required; however, OSHA
encourages employers who are able to do so to have a more robust
program of medical removal, as indeed some employers have already done.
In addition to removal from the workplace based on a positive COVID-19
test or diagnosis of COVID-19, employers may consider removal based on
COVID-19 symptoms or certain exposure or close contacts employees have
had outside of the workplace. Similarly, employers may consider
removing employees from the workplace if the employer learns that the
employee was notified by a state or local public health authority to
quarantine or isolate; the employer might even be contacted by such an
authority directly. Although this ETS does not require removal from the
workplace in those situations, the employer might choose to remove
employees from the workplace, above and beyond what is required by this
ETS.
Finally, the note to paragraph (h)(2) clarifies that this ETS does
not require employers to provide paid time to any employee for removal
as a result of a positive COVID-19 test or diagnosis of COVID-19;
however, paid time may be required by other laws, regulations, or
collective bargaining agreements or other collectively negotiated
agreements. On the other hand, the ETS does not preclude employers from
choosing to pay employees for time required for removal under this
standard. Additionally, employers should allow their employees to make
use of any accrued leave in accordance with the employer's policies and
practices on use of leave. This provision, while not placing the burden
on the employer to provide paid time, should not be read as depriving
employees of the benefits they are normally entitled to as part of
their employment.
Because it does not require employers to provide paid time to
employees who are removed for a positive COVID-19 test or diagnosis of
COVID-19, this ETS differs from OSHA's COVID-19 Healthcare ETS, which
applies to employees in the healthcare industry who are expected to be
exposed to COVID-19, and requires paid medical removal protection
benefits (Sec. 1910.502(l)(5)) for most employees. This difference
reflects the structure and focus of this ETS relative to the Healthcare
ETS. The Healthcare ETS requires employees to report symptoms of COVID-
19 to their employers, as well as positive COVID-19 tests or diagnoses
(see Sec. 1910.502(l)(2)), but does not require employees to be
regularly tested for COVID-19. A primary function of the payment for
medical removal in that standard is, therefore, to remove the potential
for financial disincentives that might deter employees from reporting
any signs or symptoms of COVID-19 that they experience. Because this
ETS already requires testing for unvaccinated workers, which should
result in employers learning of cases of COVID-19 in unvaccinated
workers, and does not otherwise require
employees to report signs and symptoms of COVID-19 to their employers,
OSHA found that requiring employer payment for removal was not
necessary in this standard.
As the note to paragraph (h) indicates, the employer may be
required to follow other laws or regulations that would require paid
medical removal. For example, if an employee covered by this ETS
believes they were exposed to COVID-19 in the workplace and then tested
positive, that employee may be entitled to workers' compensation
benefits. Workers' compensation is a system already in place to provide
benefits to employees who get sick or injured on the job from
occupational disease or a work-related injury. Some states have
expressly clarified or expanded their workers compensation rules to
allow for COVID-19 claims during the pandemic (see, e.g., Industrial
Commission of Arizona, May 15, 2020; Connecticut Executive Order No.
7JJJ, July 24, 2020; Minn. Stat. Ann. Sec. 176.011 Subd. (15)(f),
2020)).
Finally, the ETS does not contain specific requirements under this
paragraph for the employer to establish or maintain records of employee
notifications of a positive COVID-19 test or diagnosis of COVID-19 by a
licensed healthcare provider. However, should an employer determine
that a reported case of COVID-19 is work-related, the employer must
continue to record that information on the OSHA Forms 300, 300A, and
301, or on equivalent forms, if required to do so under 29 CFR part
1904. This also includes confirmed cases of COVID-19 identified under
paragraph (h) that an employer determines are work-related. Under 29
CFR part 1904, COVID-19 is a recordable illness and employers are
responsible for recording cases of COVID-19 if: (1) The case is a
confirmed case of COVID-19 as defined by the Centers for Disease
Control and Prevention (CDC); (2) the case is work-related as defined
by 29 CFR part 1904.5; and (3) the case involves one or more of the
general recording criteria in set forth in 29 CFR part 1904.7 (e.g.,
medical treatment beyond first aid, days away from work). Under 29 CFR
part 1904, employers must generally provide access to the 300 log to
employees, former employees, and their representatives with the names
of injured or ill employees included on the form. If, however, the
employee requests that their name not be entered on the 300 log, the
employer must treat their illness as a privacy concern case and may not
enter their name on the log (see 29 CFR 1904.29(b)(6), (b)(7)(vi)).
References
Centers for Disease Control and Prevention (CDC). (2021, February
18). Isolate if you are sick. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html. (CDC, February 18, 2021).
Centers for Disease Control and Prevention (CDC). (2021, June 30).
Interim Guidance for Use of Pooling Procedures in SARS-CoV-2
Diagnostic and Screening Testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html. (CDC, June 30, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
9). Interim Guidance for Antigen Testing for SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html. (CDC, September 9, 2021).
Centers for Disease Control and Prevention (CDC). (2021, September
14). Ending Isolation and Precautions for People with COVID-19:
Interim Guidance. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. (CDC, September 14, 2021).
Connecticut Executive Order No. 7JJJ. (2020, July 24). Executive
Order No. 7JJJ Protection of public health and safety during COVID-
19 pandemic and response--rebuttable presumption regarding workers
compensation benefits related to contraction of COVID-19. https://portal.ct.gov/-/media/Office-of-the-Governor/Executive-Orders/Lamont-Executive-Orders/Executive-Order-No-7JJJ.pdf. (Connecticut
Executive Order No. 7JJJ, July 24, 2020).
Food and Drug Administration (FDA). (2021, April). Coronavirus
Disease 2019 Testing Basics. https://www.fda.gov/media/140161/download. (FDA, April 2021).
Industrial Commission of Arizona. (2020, May 15). COVID-19 Workers'
Compensation Claims. https://www.azica.gov/sites/default/files/SPS%20-COVID-19%20FINAL.pdf. (Industrial Commission of Arizona, May
15, 2020).
Kucharski AJ et al. (2020). Effectiveness of isolation, testing,
contact tracing, and physical distancing on reducing transmission of
SARS-CoV-2 in different settings: a mathematical modelling study.
The Lancet Infectious Disease. 2020 Oct; 20(10): 1151-1160.
doi:10.1016/S1473-3099(20)30457-6. Epub 2020 Jun 16. PMID: 32559451;
PMCID: PMC7511527. (Kucharski et al., 2020)
Minnesota Statutes Annotated, Section 176.011 Definitions. Subd.
15(f). (2020). https://www.revisor.mn.gov/statutes/cite/176.011/pdf.
(Minn. Stat. Ann. Sec. 176.011 Subd. (15)(f), 2020)
Moghadas S et al. (2020, July 6). The implications of silent
transmission for the control of COVID-19 outbreaks. Proceedings of
the National Academy of Sciences of the United States of America,
117(30), 17513-17515. doi:https://doi.org/10.1073/pnas.2008373117.
(Moghadas et al., July 6, 2020)
Wells CR et al. (2021). Optimal COVID-19 quarantine and testing
strategies. Nature Communications 2021 Jan 7; 12(1): 356.
doi:10.1038/s41467-020-20742-8. PMID: 33414470; PMCID: PMC7788536.
(Wells et al., 2021)
I. Face Coverings
Paragraph (i) of this standard addresses the use of face coverings.
As previously discussed in Grave Danger (Section III.A. of this
preamble), COVID-19 spreads when an infected person breathes out
droplets and very small particles that contain the virus. These
droplets and particles can be breathed in by other people or land on
their eyes, noses, or mouth. Face coverings reduce the risk of droplet
transmission of COVID-19. The CDC recommends that people who are not
fully vaccinated wear a face covering (e.g., a mask) in indoor public
places. (CDC, July 14, 2021). Additional discussion on the efficacy of
face coverings is provided below.
Face coverings are simple bi-directional barriers that tend to keep
droplets, and to a lesser extent airborne particulates, on the side of
the filter from which they originate. An explanation of the term ``face
covering'', as used in this ETS, can be found in the Summary and
Explanation for paragraph (c) (Section VI.C. of this preamble). The CDC
(August 13, 2021) recommends unvaccinated people wear face coverings
when indoors to prevent getting and spreading COVID-19 mostly by
blocking large respiratory droplets from either leaving the face
covering of the wearer (source control) or by preventing someone else's
droplets from reaching the wearer (personal protection). The need for
face coverings in workplaces applies particularly to unvaccinated
workers due to their increased potential for asymptomatic and pre-
symptomatic transmission of COVID-19.
The CDC Healthcare Infection Control Practices Advisory Committee's
(HICPAC) ``Isolation Guidance'' for healthcare settings has long
recommended facemasks, among other controls, to prevent the
transmission of viruses that cause respiratory illnesses (Siegel et
al., 2007). Face coverings play an important dual role in protecting
workers from droplet transmission of COVID-19. One of their key
purposes is to function as source control. In this role, the face
covering helps protect people around the wearer by reducing the number
of infectious droplets released into the air by the wearer and limiting
the distance traveled by any particles that are released. As a result,
anyone near the wearer is exposed to fewer (if any) droplets and the
transmission risk is lowered (OSHA,
January 28, 2021; Siegel et al., 2007). Face coverings also provide a
degree of particulate filtration to reduce the amount of inhaled
particulate matter, meaning face coverings can help protect the wearer
themselves, by reducing their inhalation of droplets produced by an
infected person nearby (CDC, May 7, 2021; Brooks et al., February 10,
2021).
The efficacy of any given face covering in either functioning as
source control or protecting the wearer will depend on the
construction, design, and material used for the face covering. The CDC
has stated that ``masks are primarily intended to reduce the emission
of virus-laden droplets (``source control''), which is especially
relevant for asymptomatic or presymptomatic infected wearers who feel
well and may be unaware of their infectiousness to others, and who are
estimated to account for more than 50% of transmissions'' (CDC, May 7,
2021). The CDC has also stated that: ``Multi-layer cloth masks block
release of exhaled respiratory particles into the environment, along
with the microorganisms these particles carry. Cloth masks not only
effectively block most large droplets (i.e., 20-30 microns and larger)
but they can also block the exhalation of fine droplets and particles
(also often referred to as aerosols) smaller than 10 microns; which
increase in number with the volume of speech and specific types of
phonation. Multi-layer cloth masks can both block up to 50-70% of these
fine droplets and particles and limit the forward spread of those that
are not captured. Upwards of 80% blockage has been achieved in human
experiments that have measured blocking of all respiratory droplets,
with cloth masks in some studies performing on par with surgical masks
as barriers for source control'' (CDC, May 7, 2021). Thus, the
construction of the face covering is a significant factor in
determining its efficacy at reducing COVID-19 transmission.
While face coverings are generally effective as source control,
because of the potential variations in protective properties, OSHA has
not considered face coverings that are not certified to a consensus
standard to be personal protective equipment (PPE) under OSHA's general
PPE standard (29 CFR 1910.132), as there is insufficient assurance that
any given face covering is of safe design and construction for the work
to be performed, which is required by the PPE standard. Despite these
limitations, many of the available face coverings have proven to be
effective at providing source control, and where a face covering is
also effective in providing personal protection, the wearer will be at
reduced risk of, and could be protected from, infection. Accordingly,
over the course of the pandemic, through its guidance, OSHA has
strongly encouraged workers to wear face coverings when they are in
close contact with others to reduce the risk of spreading COVID-19
despite the shortcomings that have prevented the agency from
considering them to be PPE that complies with the requirement of the
PPE standard. To enhance the effectiveness of any face covering
required by this standard, this ETS imposes certain minimum design
criteria, consistent with CDC recommendations. Thus, the face covering
must consist of at least two layers of material that is either tightly
woven or non-woven, and the face covering must not have visible holes
or openings. CDC has found face coverings that are tightly woven and
made with at least two layers are more effective at filtering droplets
than face coverings that are loosely woven or consist of a single layer
of fabric (CDC, May 7, 2021; Ueki et al., June 25, 2020).
OSHA's determination on the importance of face coverings is
supported by a substantial body of evidence. As described in further
detail below, consistent and correct use of face coverings is widely
recognized and scientifically supported as an important evidence-based
strategy for COVID-19 control. Accordingly, with specific exceptions
relevant to outdoor areas and vaccinated persons, the CDC recommends
everyone two years of age and older wear a face covering in public
settings and when around people outside of their household (CDC, August
13, 2021). And, on January 21, 2021, President Biden issued Executive
Order 13998, which recognizes the use of face coverings or facemasks as
a necessary, science-based public health measure to prevent the spread
of COVID-19, and therefore directed regulatory action to require that
they be worn in compliance with CDC guidance while traveling on public
transportation (e.g., buses, trains, subway) and while at airports
(Executive Order 13998, 86 FR 7205, 7205 (Jan. 21, 2021); CDC, February
2, 2021). Similarly, the World Health Organization (WHO) has recognized
face coverings as a key measure in suppressing COVID-19 transmission,
and thus, saving lives. The WHO observes that face coverings serve two
purposes, to both protect healthy people from acquiring COVID-19 and to
prevent sick people from further spreading it. Since December of 2020,
the WHO has recommended that the general public wear face coverings in
indoor settings and in outdoor settings where physical distancing
cannot be maintained (WHO, December 1, 2020).
In the United States, several states have imposed statewide face
covering mandates in order to mitigate the spread of COVID-19. One
study examined data on statewide face covering mandates during March 1-
October 22, 2020, and found that statewide face covering mandates were
associated with a decline in weekly COVID-19-associated hospitalization
growth rates by up to 5.6 percentage points for adults aged 18-64 years
after mandate implementation, compared with growth rates during the 4
weeks preceding implementation of the mandate (Joo et al., February 12,
2021). Similarly, another study examined the association of state-
issued face covering mandates with COVID-19 cases and deaths during
March 1-December 31, 2020, and found mandating face coverings was
associated with a decrease in daily COVID-19 case and death growth
rates within 20 days of implementation (Guy et al., March 12, 2021).
School face covering policies for students, staff members, faculty,
and visitors are associated with a reduction in COVID-19 outbreaks.
Between July 15 and August 31, 2021, schools in Arizona were analyzed
for school mask policies, which provided that all persons, regardless
of vaccination status, were required to wear a mask indoors. The odds
of a school-associated COVID-19 outbreak in schools without a mask
requirement were 3.5 times higher than those in schools with an early
mask requirement (Odds Ratio = 3.5; 95% Confidence Interval = 1.8-6.9)
(Jehn et al., October 1, 2021).
The effectiveness of face coverings in limiting the emission and
spread of droplets has also been demonstrated in numerous studies. For
example, multiple studies in which droplets were visualized while
individuals were talking or a manikin was used to simulate coughs and
sneezes demonstrated that two-layer face coverings limited the number
of droplets released into the air, and limited the forward spread of
those not captured (Fischer et al., September 2, 2020; Verma et al.,
June 30, 2020; CDC, May 7, 2021).
The effectiveness of face coverings in preventing infections was
also observed in a number of epidemiological studies. For example, in
June of 2020 an outbreak was studied aboard the USS Theodore Roosevelt,
an environment notable for congregate living quarters, close working
environments, and a sample of mostly young, healthy adults. The
investigation found that use of face
coverings on board was associated with a 70% reduced risk of
transmission, which demonstrates that the use of face coverings,
especially among asymptomatic cases, can help mitigate future
transmission (Payne et al., June 12, 2020). Another publication,
released in July of 2020, included an investigation of a high-exposure
event among 139 clients exposed to two symptomatic hair stylists with
confirmed cases of COVID-19. Both of the stylists and all of their
clients wore face coverings during their interactions. Among 67 clients
subsequently tested for COVID-19, all test results were negative; no
symptomatic secondary cases were reported by any clients, including
those who were not tested. The study concluded that the strict use of
face coverings likely mitigated the spread of COVID-19 (Hendrix et al.,
July 17, 2020).
Several other observational epidemiological studies have reviewed
data regarding the ``real-world'' effectiveness of face covering usage.
First, in a study of 124 Beijing households with one or more
laboratory-confirmed case of COVID-19, face covering use by both the
index patient and all family contacts before the index patient
developed symptoms reduced secondary transmission (i.e., infections
occurring within two weeks of symptom onset in the index case) within
the households by 79% (Wang et al., May 11, 2020). Second, a
retrospective case-control study from Thailand documented that, among
more than 1,000 persons interviewed as part of contact tracing
investigations, those who reported having always worn a face covering
during high-risk exposures experienced a greater than 70% reduced risk
of infection compared with persons who did not wear face coverings
under these circumstances. The risk for infection was not significantly
lower in those who reported only sometimes wearing face coverings
compared to those who did not wear face coverings at all. This evidence
supports the conclusion that face coverings must be worn consistently
and correctly to meaningfully reduce the risk of infection (Doung-ngern
et al., September 14, 2020).
Community-level analyses have also confirmed the benefit of
universal face covering use in: A unified hospital system (Wang et al.,
July 14, 2020); a German city (Mitze et al., June 1, 2020); a U.S.
state (Gallaway et al., October 6, 2020); a panel of 15 U.S. states and
Washington, DC (Lyu and Wehby, June 16, 2020; Hatzius et al., June 29,
2020); as well as both Canada (Karaivanov et al., October 1, 2020) and
the U.S. (Chernozhukov et al., September 15, 2020) nationally. Each
community analysis demonstrated that, following universal face covering
directives from both organizational and political leadership, new
infections were shown to fall significantly. These analyses have also
shown reductions in mortality and the need for lockdowns, with their
associated monetary/gross domestic product losses (Leffler et al.,
December 2, 2020; Hatzius et al., June 29, 2020). Additionally,
multiple investigations involving infected passengers aboard flights
longer than ten hours strongly suggest that face covering usage
prevented in-flight transmissions, as demonstrated by the absence of
infection developing in other passengers and crew in the 14 days
following exposure (Schwartz et al., April 14, 2020; Freedman and
Wilder-Smith, September 25, 2020).
Researchers from the COVID-19 Systematic Urgent Review Group Effort
investigated the effects of face coverings and eye protection on virus
transmission in both healthcare and non-healthcare settings. They
identified 172 observational studies for their systematic review and 44
comparative studies for their meta-analysis, including data on 25,697
COVID-19, SARS, or MERS patients. They concluded for the general
public, based mainly on evidence from face covering use within
households and among contacts of cases, that disposable surgical masks
or face coverings (reusable multi-layer cotton face coverings) are
associated with protection from viral transmission. Through the meta-
analysis, combining 39 of the studies' results, they found a 14.3%
reduction in the difference of anticipated absolute effect (e.g., the
chance of viral infection or transmission) between no face covering and
face covering groups (Chu et al., June 27, 2020).
Ueki et al. (June 25, 2020) evaluated the effectiveness of cotton
face coverings, facemasks, and N95s (a commonly used respirator) in
preventing transmission of SARS-CoV-2 using a laboratory experimental
setting with manikins. The researchers found that all offerings
provided some measure of protection as source control, limiting
droplets expelled from both infected and uninfected wearers. For
instance, when spaced roughly 20 inches apart, an uninfected person can
reduce inhalation of infectious virus by 37% by wearing a cotton face
covering. If only the infected person wears a cotton face covering, the
amount breathed in by the uninfected recipient is reduced by 57%.
However, if both individuals wear a cotton face covering, the exposure
is reduced 67%. If both are wearing facemasks, exposure is reduced by
76%. When an infected individual wore an N95 respirator, exposure was
reduced by 96% or, w
