[Federal Register Volume 86, Number 116 (Monday, June 21, 2021)]
[Rules and Regulations]
[Pages 32376-32628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12428]
Vol. 86
Monday,
No. 116
June 21, 2021
Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Occupational Exposure to COVID-19; Emergency Temporary Standard;
Interim Final Rule
Federal Register / Vol. 86 , No. 116 / Monday, June 21, 2021 / Rules
and Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2020-0004]
RIN 1218-AD36
Occupational Exposure to COVID-19; 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 healthcare and
healthcare support service workers from occupational exposure to COVID-
19 in settings where people with COVID-19 are reasonably expected to be
present. During the period of the emergency standard, covered
healthcare employers must develop and implement a COVID-19 plan to
identify and control COVID-19 hazards in the workplace. Covered
employers must also implement other requirements to reduce transmission
of COVID-19 in their workplaces, related to the following: Patient
screening and management; Standard and Transmission-Based Precautions;
personal protective equipment (PPE), including facemasks or
respirators; controls for aerosol-generating procedures; physical
distancing of at least six feet, when feasible; physical barriers;
cleaning and disinfection; ventilation; health screening and medical
management; training; anti-retaliation; recordkeeping; and reporting.
The standard encourages vaccination by requiring employers to provide
reasonable time and paid leave for employee vaccinations and any side
effects. It also encourages use of respirators, where respirators are
used in lieu of required facemasks, by including a mini respiratory
protection program that applies to such use. Finally, the standard
exempts from coverage certain workplaces where all employees are fully
vaccinated and individuals with possible COVID-19 are prohibited from
entry; and it exempts from some of the requirements of the standard
fully vaccinated employees in well-defined areas where there is no
reasonable expectation that individuals with COVID-19 will be present.
DATES:
Effective dates: The rule is effective June 21, 2021. The
incorporation by reference of certain publications listed in the rule
is approved by the Director of the Federal Register as of June 21,
2021.
Compliance dates: Compliance dates for specific provisions are in
29 CFR 1910.502(s). Employers must comply with all requirements of this
section, except for requirements in paragraphs (i), (k), and (n) by
July 6, 2021. Employers must comply with the requirements in paragraphs
(i), (k), and (n) by July 21, 2021.
Comments due: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by July 21, 2021 in Docket No. OSHA-2020-0004. Comments on
the information collection determination described in Section VII.K of
the preamble (OMB Review under the Paperwork Reduction Act of 1995) may
be submitted by August 20, 2021 in Docket Number OSHA-2021-0003.
ADDRESSES: In accordance with 28 U.S.C. 2112(a), the agency designates
Edmund C. Baird, Associate Solicitor of Labor 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-2020-0004, 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-2020-0004). 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-2020-0004 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,
Director, Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email meilinger.francis2@dol.gov.
For technical inquiries: Contact Andrew Levinson, Directorate of
Standards and Guidance, U.S. Department of Labor; telephone (202) 693-
1950.
SUPPLEMENTARY INFORMATION: The preamble to the ETS on occupational
exposure to COVID-19 follows this outline:
Table of Contents
I. Executive Summary
II. History of COVID-19
III. Pertinent Legal Authority
IV. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
V. Need for Specific Provisions of the ETS
VI. Feasibility
A. Technological Feasibility
B. Economic Feasibility
VII. Additional Requirements
VIII. Summary and Explanation of the ETS
Authority and Signature
I. 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 exposed
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 III of this preamble).
For the first time in its 50-year history, OSHA faces a new hazard
so grave that it has killed nearly 600,000
people in the United States in barely over a year, and infected
millions more (CDC, May 24, 2021a). And the impact of this new illness
has been borne disproportionately by the healthcare and healthcare
support workers tasked with caring for those infected by this disease.
As of May 24, 2021, over 491,816 healthcare workers have contracted
COVID-19, and more than 1,600 of those workers have died (CDC, May 24,
2021b). OSHA has determined that employee exposure to this new hazard,
SARS-CoV-2 (the virus that causes COVID-19), presents a grave danger to
workers in all healthcare settings in the United States and its
territories where people with COVID-19 are reasonably expected to be
present. This finding of grave danger is based on the science of how
the virus spreads and the elevated risk in workplaces where COVID-19
patients are cared for, as well as the adverse health effects suffered
by those diagnosed with COVID-19, as discussed in Grave Danger (Section
IV.A. of this preamble).
OSHA has also determined that an ETS is necessary to protect
healthcare and healthcare support employees in covered healthcare
settings from exposures to SARS-CoV-2, as discussed in Need for the ETS
(Section IV.B. of this preamble). Workers face a particularly elevated
risk of exposure to SARS-CoV-2 in settings where patients with
suspected or confirmed COVID-19 receive treatment or where patients
with undiagnosed illnesses come for treatment (e.g., emergency rooms,
urgent care centers), especially when providing care or services
directly to those patients. Through its enforcement efforts to date,
OSHA has encountered significant obstacles, revealing that existing
standards, regulations, and the OSH Act's General Duty Clause are
inadequate to address the COVID-19 hazard for employees covered by this
ETS. The agency has determined that a COVID-19 ETS is necessary to
address these inadequacies. Additionally, as states and localities have
taken increasingly more divergent approaches to COVID-19 workplace
regulation--ranging from states with their own COVID-19 ETSs to states
with no workplace protections at all--it has become clear that a
Federal standard is needed to ensure sufficient protection for
healthcare employees in all states.
The development of safe and highly effective vaccines and the on-
going nationwide distribution of these vaccines are encouraging
milestones in the nation's response to COVID-19. OSHA recognizes the
promise of vaccines to protect workers, but as of the time of the
promulgation of the ETS, vaccination has not eliminated the grave
danger presented by the SARS-CoV-2 virus to the entire healthcare
workforce. Indeed, approximately a quarter of healthcare workers have
not yet completed COVID-19 vaccination (King et al., April 24, 2021).
Nonetheless, vaccination is critical in combatting COVID-19, and the
standard requires employers to provide paid leave to employees so that
they can be vaccinated and recover from any side effects. Additionally,
certain workplaces and well-defined areas where all employees are fully
vaccinated are exempted from all of the standard's requirements, and
certain fully vaccinated workers are exempted from several of the
standard's requirements. OSHA will continue to monitor trends in COVID-
19 infections and deaths as more of the workforce and the general
population become vaccinated 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 the ETS, as appropriate.
To protect workers in the meantime, however, a multi-layered
approach to controlling occupational exposures to SARS-CoV-2 in
healthcare workplaces is required. As discussed in the Need for
Specific Provisions (Section V of this preamble), OSHA relied on the
best available science for its decisions concerning appropriate
provisions for the ETS and its determinations regarding the kind and
degree of protective actions needed to protect against exposure to
SARS-CoV-2 at work and the feasibility of instituting these provisions.
More specifically, the agency's analysis demonstrates that an effective
COVID-19 control program must utilize a suite of overlapping controls
in a layered approach to protect workers from workplace exposure to
SARS-CoV-2. OSHA emphasizes that the infection control practices
required by the ETS are most effective when used together; however,
they are also each individually protective.
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 VI of
this preamble). Table I.-1, which is derived from material presented in
Section VI of this preamble, provides a summary of OSHA's best estimate
of the costs and benefits of the rule using a discount rate of 3
percent. The specific requirements of the ETS are outlined and
described in the Summary and Explanation (Section VIII of this
preamble). OSHA requests comments on the provisions of the ETS and
whether it should be adopted as a permanent standard.
[GRAPHIC] [TIFF OMITTED] TR21JN21.000
II. History of COVID-19
The global pandemic of respiratory disease (coronavirus disease
2019 or ``COVID-19'') caused by a novel coronavirus (SARS-CoV-2) has
been taking an enormous toll on individuals, workplaces, and
governments around the world since early 2020. According to the World
Health Organization (WHO), as of May 24, 2021, there had been
166,860,081 confirmed cases of COVID-19 globally, resulting in more
than 3,459,996 deaths (WHO, May 24, 2021). In the United States as of
the same date, the CDC reported over 32,947,548 cases in the United
States and over 587,342 deaths due to the disease (CDC, May 24, 2021a;
CDC, May 24, 2021c). Among healthcare workers specifically, as of May
24, 2021, 491,816 healthcare workers in the United States had
contracted COVID-19, and at least 1,611 of those workers had died; both
of those figures are likely an undercount (CDC, May 24, 2021b).
The first confirmed case of COVID-19 was identified in the Hubei
Province of China in December of 2019 (Chen et al., August 6, 2020). On
December 31, 2019, China reported to the WHO that it had identified
several influenza-like cases of unknown cause in Wuhan, China (WHO,
January 5, 2020). Soon, COVID-19 infections had spread throughout Asia,
Europe, and North and South America. By February 2020, 58 other
countries had reported COVID-19 cases (WHO, March 1, 2020). By March
2020, widespread local transmission of the virus was established in 88
countries. Because of the widespread transmission and severity of the
disease, along with what the WHO described as alarming levels of
inaction, the WHO officially declared COVID-19 a pandemic on March 11,
2020 (WHO, March 11, 2020).
The first reported case of COVID-19 in the United States was in the
state of Washington, on January 21, 2020, in a person who had returned
from Wuhan, China on January 15, 2020 (CDC, January 21, 2020). On
January 31, 2020, the COVID-19 outbreak was declared to be a U.S.
public health emergency (US DHHS, January 31, 2020). After the initial
report of the virus in January 2020, a steep increase in COVID-19 cases
in the U.S. was observed though March and early April. In the six weeks
between March 1, 2020 and April 12, 2020, the 7-day moving average of
new cases rose from only 57 to 31,779 (CDC, May 24, 2021d). The
President declared the COVID-19 outbreak a national emergency on March
13, 2020 (The White House, March 13, 2020). As of March 19, 2020, all
50 states and the District of Columbia had declared emergencies related
to the pandemic
(NGA, March 19, 2020; NGA, December 4, 2020; Ayanian, June 3, 2020).
The U.S. Food and Drug Administration (FDA) issued or expanded
emergency use authorizations (EUAs) for three COVID-19 vaccines between
December 2020 and May 2021. Currently, everyone in the United States
age 12 and older is eligible to receive a COVID-19 vaccine. As of May
24, 2021, the CDC reported that 163,907,827 people had received at
least one dose of vaccine and 130,615,797 people were fully vaccinated,
representing 45 percent and 32.8 percent of the total U.S. population,
respectively (CDC, May 24, 2021e). Vaccination rates are higher among
people ages 65 and older than among the rest of the population.
Despite the relatively rapid distribution of vaccines in many areas
of the U.S., a substantial proportion of the working age population
remains unvaccinated and susceptible to COVID-19 infection, including
approximately a quarter of all healthcare and healthcare support
workers (King et al., April 24, 2021). And, as discussed in more detail
in Grave Danger (Section IV.A. of this preamble), because workers in
healthcare settings where COVID-19 patients are treated continue to
have regular exposure to SARS-CoV-2 and any variants that develop, they
remain at an elevated risk of contracting COVID-19 regardless of
vaccination status. Therefore, OSHA has determined that a grave danger
to healthcare and healthcare support workers remains, despite the
fully-vaccinated status of some workers, and that an ETS is necessary
to address this danger (see Grave Danger and Need for the ETS (Sections
IV.A. and IV.B. of this preamble)).
References
Ayanian, JZ. (2020, June 3). Taking shelter from the COVID storm.
JAMA Health Forum. https://jamanetwork.com/channels/health-forum/fullarticle/2766931. (Ayanian, June 3, 2020).
Centers for Disease Control and Prevention (CDC). (2020, January
21). First travel-related case of 2019 novel coronavirus detected in
United States. https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html. (CDC, January 21, 2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a)
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021b)
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Daily Trends in Number
of COVID-19 Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May
24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations. (CDC, May 24, 2021e).
Chen, Y.-T, et al., (2020, August 6). An examination on the
transmission of COVID-19 and the effect of response strategies: A
comparative analysis. International Journal of Environmental
Research and Public Health 17(16):5687. https://www.mdpi.com/1660-4601/17/16/5687. (Chen et al., August 6, 2020).
King, WC, et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
National Governor's Association (NGA). (2020, March 19).
Coronavirus:what you need to know. https://www.nga.org/coronavirus/.
(NGA, March 19, 2020).
National Governor's Association (NGA). (2020, December 4). Summary
of state pandemic mitigation actions. https://www.nga.org/coronavirus-mitigation-actions/. (NGA, December 4, 2020).
The White House. (2020, March 13). Proclamation on declaring a
national emergency concerning the novel coronavirus disease (COVID-
19) outbreak. https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. (The White House, March 13, 2020).
United States Department of Health and Human Services (US DHHS).
(2020, January 31). Determination that a public health emergency
exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx. (US DHHS, January 31, 2020).
World Health Organization (WHO). (2020, January 5). Emergencies
preparedness, response--Pneumonia of unknown cause--China. Disease
outbreak news. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/. (WHO, January 5, 2020).
World Health Organization (WHO). (2020, March 1). Coronavirus
disease 2019 (COVID-19) situation report--41. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200301-sitrep-41-covid-19.pdf?sfvrsn=6768306d_2. (WHO, March 1, 2020).
World Health Organization (WHO). (2020, March 11). Coronavirus
disease 2019 (COVID-19) situation report--51. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-51-covid-19.pdf?sfvrsn=1ba62e57_10. (WHO, March 11, 2020).
World Health Organization (WHO). (2021, May 24). WHO Coronavirus
Disease (COVID-19) Dashboard. https://covid19.who.int/table. (WHO,
May 24, 2021).
III. 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 Industry 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. 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 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., Inc. v. Donovan, 452
U.S. 490, 514 (1981); 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). Furthermore, 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.
The OSH Act states that the Secretary ``shall'' issue an emergency
temporary standard (ETS) if he finds 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 he determines 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.
For that reason, ETSs have been referred to as the ``most dramatic
weapon in [OSHA's] arsenal.'' Asbestos Info. Ass'n/N. Am. v. OSHA, 727
F.2d 415, 426 (5th Cir. 1984).
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, OSHA need not wait
for deaths to occur before promulgating an ETS, see Fla. Peach Growers
Ass'n., 489 F.2d at 130. 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. Department of Labor, 486 F.2d
98, 102 n.3 (3d Cir. 1973). In demonstrating that an ETS is necessary,
the Fifth Circuit considered whether OSHA had shown that there were no
other means of addressing the risk than 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).
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.
American 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'' and has the
``prerogative to choose between conflicting evidence.'' Indus. Union
Dep't, AFL-CIO, 448 U.S. at 656; 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.' '' Am. Textile Mfrs. Inst., 452 U.S. 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).
It is crucial to note that the language of section 6(c)(1) is not
discretionary: The Secretary ``shall'' provide for an ETS when OSHA
makes the prerequisite findings of grave danger and necessity. 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)).
IV. Rationale for the ETS
A. Grave Danger
I. Introduction
On January 31, 2020, the Secretary of Health and Human Services
(HHS) declared COVID-19 to be a public health emergency in the U.S.
under section 319 of the Public Health Service Act. The World Health
Organization declared COVID-19 to be a global health emergency on the
same day. President Donald Trump declared the COVID-19 outbreak to be a
national emergency on March 13, 2020 (The White House, March 13, 2020).
HHS renewed its declaration of COVID-19 as a public health emergency
effective April 21, 2021 (HHS, April 15, 2021).\2\
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\2\ HHS declarations of public health emergencies last for 90
days and then can be considered for renewal (https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx).
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Consistent with these declarations, and in carrying out its legal
duties under the OSH Act, OSHA has determined that healthcare employees
face a grave danger from the new hazard of workplace exposures to SARS-
CoV-2 except under a limited number of situations (e.g., a fully
vaccinated workforce in a breakroom).\3\ The virus is both a physically
harmful agent and a new hazard, and it can cause severe illness,
persistent health effects, and death (morbidity and mortality,
respectively) from the subsequent development of the disease, COVID-
19.\4\ OSHA bases its grave danger determination on evidence
demonstrating the lethality of the disease, the serious physical and
psychiatric health effects of COVID-19 morbidity (in mild-to-moderate
as well as in severe cases), and the transmissibility of the disease in
healthcare settings where people with COVID-19 are reasonably expected
to be present. The protections of this ETS--which will apply, with some
exceptions, to healthcare settings where people may share space with
COVID-19 patients or interact with others who do--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\ References in this preamble to healthcare employees and
healthcare workers indicate those employees covered by the
protections in the ETS, including employees providing healthcare
support services.
\4\ 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 these two
terms interchangeably in some parts of this preamble.
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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. Secretary,
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)). 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, healthcare employees providing
care directly to known or suspected COVID-19 patients are required to
have close contact with infected individuals, and other employees in
those settings also work in an environment in which they have little
control over their ability to limit contact with individuals who may be
infected with COVID-19 even when not engaged in direct patient care.
Accordingly, even though SARS-CoV-2 is a hazard to which employees are
exposed both inside and outside the workplace, healthcare employees in
workplaces where individuals with suspected or confirmed COVID-19
receive care have limited ability to avoid exposure resulting from a
work setting where those individuals are present. OSHA has a mandate to
protect employees from hazards they are exposed to at work, even if
they may be exposed to similar hazards before and after work.
As described above in Section III, Legal Authority, ``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, which is in contrast to the adverse health effects of cases
of COVID-19, which are formally referenced as ranging from ``mild'' to
``critical.'' \5\ 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\ Definitions of severity of COVID-19 illness used in this
document are found in the National Institutes of Health's COVID-19
treatment guidelines (https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/)
(NIH, December 17, 2020).
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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, 656, 100 S. Ct. 2844, 2871, 65 L.
Ed. 2d 1010 (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 over six
months constituted a grave danger (Asbestos Info. Ass'n/N. Am., 727
F.2d at 424). In stark contrast, as of May 24, 2021, 1,611 healthcare
personnel have died (out of 491,816 healthcare COVID-19 cases where
healthcare personnel status and death status is known by the CDC) (May
24, 2021a). This is likely an undercount of cases and deaths as the
healthcare personnel status is not known for 81.63% of cases and death
status is unknown in 20.42% of cases where healthcare personnel status
is known. OSHA estimates that this rule would save almost 800 worker
lives over the course of the next six months as noted in Table I.-1 in
the Executive Summary. 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.
OSHA's previous ETSs addressed physically harmful agents that had
been familiar to the agency for many years prior to the ETS. In most
cases, the 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)). In no case
did OSHA claim that an ETS was required to address a grave danger from
a substance that had only recently come into existence. Thus, no court
has had occasion to separately 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, SARS-CoV-2 was
not known to exist until January 2020. Since then, more than 3 million
people have died worldwide and nearly 600,000 people have died in the
U.S. alone (WHO, May 24, 2021; CDC, May 24, 2021b). This monumental
tragedy is largely handled by healthcare employees who provide care for
those who are ill and dying, leading to introduction of the virus not
only in their daily lives in the community but also in their workplace,
and more than a thousand healthcare workers have died from COVID-19.
Clearly, exposure to SARS-CoV-2 is a new hazard that presents a grave
danger to workers in the U.S.
In the following sections within Grave Danger, OSHA summarizes the
best available scientific evidence on employee exposure to SARS-CoV-2
and shows how that evidence establishes COVID-19 to be a grave danger
to healthcare employees. OSHA's determination that there is a grave
danger to healthcare employees rests on the severe health consequences
of COVID-19, the high risk to employees of developing the disease as a
result of transmission of SARS-CoV-2 in the workplace, and that these
workplace settings provide direct care to known or suspected COVID-19
cases. With respect to the health consequences of COVID-19, OSHA finds
a grave danger to employees based on mortality data showing
unvaccinated people of working age (18-64 years old) have a 1 in 217
chance of dying when they contract the disease (May 24, 2021c; May 24,
2021d). When broken down by age range, that includes a 1 in 788 chance
of dying for those aged 30-39, a 1 in 292 chance of dying for those
aged 40-49, and as much as a 1 in 78 chance of dying for those aged 50-
64 (May 24, 2021c; May 24, 2021d). Furthermore, workers in racial and
ethnic minority groups are often over-represented in many healthcare
occupations and face higher risks for SARS-CoV-2 exposure and
infection, as noted in a study on workers in Massachusetts (Hawkins,
June 15, 2020) and discussed in more detail in the section ``Observed
Disparities in Risk Based on Race and Ethnicity,'' below. While
vaccination greatly reduces adverse health outcomes to healthcare
workers, it does not eliminate the grave danger faced by vaccinated
healthcare workers in settings where patients with suspected or
confirmed COVID-19 receive treatment (CDC, April 27, 2021; Howard, May
22, 2021).
OSHA also finds a grave danger based on the severity and prevalence
of other health effects caused by COVID-19, short of death. While some
SARS-CoV-2 infections are asymptomatic, even the cases labeled ``mild''
by the CDC involve symptoms that far exceed in severity the group of
symptoms dismissed in the Florida Peach Growers Ass'n decision as not
rising to the level of grave danger required by the OSH Act (i.e.,
minor cases of nausea, excessive salivation, perspiration, or blurred
vision) (489 F.2d at 132). Even ``mild'' cases of COVID-19--where
hypoxia (low oxygen in the tissues) is not present--require isolation
and may require medical intervention and multiple weeks of
recuperation, while severe cases of COVID-19 typically require
hospitalization and a long recovery period (see the section on ``Health
Effects,'' below). For example, in a study of 1,733 patients, three
quarters of remaining hospitalized cases and approximately half of all
symptomatic cases resulted in the individual continuing to experience
at least one symptom (e.g., fatigue, breathing difficulties) at least
six months after initial infection (Huang et al., January 8, 2021;
Klein et al., February 15, 2021). These cases might be referred to as
``long COVID'' because symptoms persist long after recovery from the
initial illness, and could potentially be significant enough to
negatively affect an individual's ability to work or perform other
everyday activities.
Finally, OSHA concludes that the serious and potentially fatal
consequences of COVID-19 pose a particular threat to employees, as the
nature of SARS-CoV-2 transmission readily enables the virus to spread
when employees are working in spaces shared with others (e.g., co-
workers, patients, visitors), a common characteristic of healthcare
settings where direct care is provided. While not every setting is
represented in the evidence that OSHA has assembled, the best available
evidence illustrates that clusters and outbreaks \6\ of COVID-19 have
occurred in a wide variety of occupations in healthcare settings. The
scientific
evidence of SARS-CoV-2 transmission, presented below, makes clear that
the virus can be spread wherever an infectious person is present and
shares space with other people, and OSHA therefore expects transmission
across healthcare workplaces where known or suspected COVID-19 patients
are treated (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 wherever that substance is present in a workplace)).
OSHA's conclusion that there is a grave danger to which employees are
specifically exposed is further supported by evidence demonstrating the
widespread prevalence of the disease across the country generally. As
of May 2021, over 32 million cases of COVID-19 have been reported in
the United States (CDC, May 24, 2021e). Over 1 in 11 people of working
age have been reported infected (cases for individuals age 18-64, CDC,
May 24, 2021d; estimated number of people ages 15-64, Census Bureau,
June 25, 2020). And data shows that employees across a myriad of
workplace settings have suffered death and serious illness from COVID-
19 through the duration of the pandemic (WSDH and WLNI, December 17,
2020; Allan-Blitz et al., December 11, 2020; Marshall et al., June 30,
2020).\7\ From May 18, 2021 to May 24, 2021, COVID-19 resulted in 4,216
cases and nine deaths for healthcare personnel each day (CDC, May 18,
2021; CDC, May 24, 2021a). Thus, COVID-19 continues to present a grave
danger to the nation's healthcare employees.
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\6\ ``Outbreaks'' are generally defined as an increase, often
sudden, in the number of cases of a disease above what is normally
expected in a limited geographic area. ``Clusters'' are generally
defined as an unusual number of cases grouped in one place that is
more than expected to occur (CDC, May 18, 2012). Researchers
investigating outbreaks and have to decide how to define the
geographic area, while researchers investigating clusters may use a
variety of strategies to determine what is ``unusual.'' While the
terms are slightly different, their overall significance to the
grave danger discussion is the same. For the studies and reports
relied upon in this section, OSHA will generally use whichever term
is used in the study or report itself.
\7\ Of note, on February 25, 2021, the Superior Court of
California issued a decision denying a motion for a preliminary
injunction seeking to restrain the California Occupational Safety
and Health Standards Board from enforcing a COVID-19 ETS promulgated
on November 30, 2020 (Nat'l Retail Fed'n v. Cal. Dep't of Indus.
Relations, Div. of Occupational Safety & Health, Case Nos. CGC-20-
588367, CPF-21-517344 (Cal. Super. Ct., Feb. 25, 2021)). In its
decision, the court found that COVID-19 presents an emergency to
employees, noting that any argument to the contrary was ``fatuous''
(id. at 17). The court found that ``the virus spreads any place
where persons gather and come into contact with one another--whether
it happens to be an office building, a meatpacking plant, a wedding
reception, a business conference, or an event in the Rose Garden of
the White House. Workplaces, where employees often spend eight hours
a day or more in close proximity to one another, are no exception,
which of course is why the pandemic has emptied innumerable office
buildings, stores, shopping centers, restaurants, and bars around
the world'' (id. at 17-18 (emphasis in original) (footnotes
omitted)).
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References
Allan-Blitz, LT et al., (2020, December 11). High frequency and
prevalence of community-based asymptomatic SARS-CoV-2
infection.medRxivpre-print. https://www.medrxiv.org/content/10.1101/2020.12.09.20246249v1. (Allan-Blitz et al., December 11, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 27).
Updated healthcare infection prevention and control recommendation
in response to COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html.
(CDC, April 27, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 18).
COVID Data Tracker: Cases & deaths among healthcare personnel.
https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
(CDC, May 18, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Deaths by age group. https://covid.cdc.gov/covid-data-tracker/#demographics (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Cases by age group. https://covid.cdc.gov/covid-data-tracker/#demographics (CDC, May 24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021e).
Census Bureau. (2020, June 25). Annual estimates of the resident
population for selected age groups by sex for the United States:
April 2010 to July 1, 2019. https://www2.census.gov/programs-surveys/popest/tables/2010-2019/national/asrh/nc-est2019-agesex.xlsx. (Census Bureau, June 25, 2020).
Hawkins, D. (2020, June 15). Differential occupational risk for
COVID-19 and other infection exposure according to race and
ethnicity. American Journal of Industrial Medicine 63:817-820.
https://doi.org/10.1002/ajim.23145. (Hawkins, June 15, 2020).
Howard, J. (2021). ``Response to request for an assessment by the
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services, of the current hazards facing healthcare workers from
Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22, 2021).
Huang, C et al., (2021, January 8). 6-month consequences of COVID-19
in patients discharged from hospital: A cohort study. The Lancet
397:220-232. https://doi.org/10.1016/S0140-6736(20)32656-8. (Huang
et al., January 8, 2021).
Klein, H et al., (2021, February 15). Onset, duration and unresolved
symptoms, including smell and taste changes, in mild COVID-19
infections: A cohort study in Israeli patients. Clinical
Microbiology and Infection 27(5):769-774. https://doi.org/10.1016/j.cmi.2021.02.008. (Klein et al., February 15, 2021).
Marshall, K et al., (2020, June 30). Exposure before issuance of
stay-at-home orders among persons with laboratory-confirmed COVID-
19--Colorado, March 2020. Morbidity and Mortality Weekly Report:
69(26):847-9. (Marshall et al., June 30, 2020).
United States Department of Health and Human Services (US DHHS).
(2021, April 15). Renewal of Determination That A Public Health
Emergency Exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-15April2021.aspx. (HHS, April 15, 2021).
Washington State Department of Health and Washington State
Department of Labor and Industries (WSDH and WDLI). (2020, December
17). COVID-19 confirmed cases by industry sector. Publication Number
421-002. https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/data-tables/IndustrySectorReport.pdf. (WSDH and WDLI,
December 17, 2020).
The White House. (2020, March 13). Proclamation on declaring a
national emergency concerning the novel coronavirus disease (COVID-
19) outbreak. https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. (The White House, March 13, 2020).
World Health Organization (WHO). (2021, May 24). WHO Coronavirus
Disease (COVID-19) Dashboard. https://covid19.who.int/table. (WHO,
May 24, 2021).
II. Nature of the Disease
a. Health and Other Adverse Effects of COVID-19
Death From COVID-19
COVID-19 is a potentially fatal disease. As of May 24, 2021, there
had been 587,432 deaths from the disease out of 32,947,548 million
infections in the United States alone (CDC, May 24, 2021a; CDC, May 24,
2021b). For the U.S. population as a whole (i.e., unlinked to known
SARS-CoV-2
infections) as of May 24, 2021, 1.8 out of every 1,000 people have died
from COVID-19 (CDC, May 24, 2021a). COVID-19 was the third leading
cause of death in the United States in 2020 among those aged 45 to 84,
trailing only heart disease and cancer (Woolf, January 12, 2021).
During the surges in the spring and fall/winter of 2020, COVID-19 was
the leading cause of death. Despite a decrease in recent weeks, the
death rate remains high (7-day moving average death rate of 500 on May
23, 2021) (CDC, May 24, 2021c). Not only are healthcare employees
included in these staggering figures, they are exposed to COVID-19 at a
much higher frequency than the general population while providing
direct care for both sick and dying COVID-19 patients during their most
infectious moments.
The impact of morbidity and mortality on healthcare employees might
also be underreported. The information associated with cases and deaths
are incomplete. Only 18.37% of cases were reported with information on
whether or not the infected individual was a healthcare employee (CDC,
May 24, 2021d). For those who were identified as healthcare personnel,
only 79.58% of these cases noted whether the individual survived the
illness (CDC, May 24, 2021d). Despite the incomplete data, the toll on
healthcare personal is clear. As of May 24, 2021, CDC reported 491,816
healthcare personnel cases (10% of cases that included information on
healthcare personnel status) and 1,611 fatalities (0.4% of healthcare
employee cases with known death status). This number is staggering when
compared with, for example, the 2018-2019 influenza season, during
which only 0.1% of known influenza infections were estimated to be
fatal for the entire population (CDC, October 5, 2020).
The risk of mortality and morbidity from COVID-19 has changed, and
may continue to change over time. Viruses mutate and those mutations
can result in variants of concern that may be more transmissible, cause
more severe illness, or impact diagnostics, treatments, or vaccines
(CDC, May 5, 2021). For example, the UK's New and Emerging Respiratory
Virus Threats Advisory Group (NERVTAG) issued a report on how risk
might have changed with the development of a new variant there called
``B.1.1.7'' (February 11, 2021). The group determined that analysis
from multiple different datasets indicated that B.1.1.7 infections
resulted in an increased risk of hospitalization and death compared
with the ancestral virus and other variants in circulation. Challen et
al., (March 10, 2021) found that B.1.1.7 increased mortality risk by
64%. As virus mutations result in variants of concern, the
effectiveness of medical countermeasures such as therapeutics and
vaccines might be affected. Lastly, depending on the variant, potential
immune escape properties of the virus may increase a person's
susceptibility to reinfection.
Severe and Critical Cases of COVID-19
Apart from mortality, COVID-19 causes significant morbidity that
can result in incurable, permanent, and non-fleeting consequences. As
discussed below, people who become ill with COVID-19 might require
hospitalization and specialized treatment, and can suffer respiratory
failure, blood clots, long-term cardiovascular effects, organ damage,
and significant neurological and psychiatric effects. Approximately
6.7% of COVID-19 cases are severe and require hospitalization and more
specialized care (total hospitalizations and total cases, CDC, May 24,
2021e; CDC, May 24, 2021f). Given that this is a novel virus, long-term
effects are still unknown. A severe case of COVID-19 is described as
when the patient presents with hypoxia and is in need of oxygen therapy
(NIH, April 21, 2021a). Cases become critical when respiratory failure,
septic shock, and/or multiple organ dysfunction occurs.
The majority of the data currently available on the health outcomes
for hospitalized patients is derived from the first surge of the
pandemic between March and May of 2020. However, newer data indicates
that health outcomes for hospitalized patients have changed over the
course of the pandemic. A study from Emory University reviewed COVID-19
patient data from a large multi-hospital healthcare network and
compared the data from the first surge early in the pandemic (March 1
to May 30, 2020) with the second surge that occurred in the summer of
2020 (June 1 to September 13, 2020) (Meena et al., March 1, 2021). The
study found that during the second surge, ICU admission decreased from
38% to 30%, ventilator use decreased from 26% to 15%, and mortality
decreased from 15% to 9%. The study authors postulated that improved
patient outcomes during the second stage may have resulted in part from
aggressive anticoagulation therapies to prevent venous thromboembolism.
Similar findings were reported in a retrospective study of 20,736
COVID-19 patients admitted to 107 hospitals in 31 states from March
through November 2020 (Roth et al., May 3, 2021). The proportions of
patients placed on mechanical ventilation dropped from 23.3% in March
and April 2020 to 13.9% in September through November 2020. During
those same respective time periods, mortality rates dropped from 19.1%
to 10.8%. The reasons for the reductions in mechanical ventilation and
mortality are not known, but study authors postulated that reductions
in mechanical ventilation may have resulted from increased use of
noninvasive ventilation, high flow nasal oxygen, and prone positioning.
They hypothesized that the high patient count and staff unfamiliarity
with infection control procedures that were being rapidly implemented
in March and April could have accounted for the high mortality rate
during that period. In addition, the authors noted that changes in
pharmacology treatments occurred during that time period, but their
impact on improved outcomes is not known.
This data on improvements in health outcomes between earlier and
later stages of the pandemic is significant, but also demonstrates that
overall health outcomes for hospitalized COVID-19 patients still remain
poor. Even with these improvements in health outcomes, COVID-19 still
results in considerable loss of life and significant adverse health
outcomes for patients hospitalized with COVID-19. The COVID-19-
Associated Hospitalization Surveillance Network (COVID-NET), which
conducts population-based surveillance in select U.S. counties,
reported a cumulative hospitalization rate of 1 in 255 people between
the ages of 18 and 49 as well as 1 in 123 people between the ages of 50
and 64 between March 1, 2020, and May 15, 2021 (CDC, May 24, 2021g).
Patients hospitalized with COVID-19 frequently need supplemental
oxygen and supportive management of the disease's most common
complications, which are discussed in further detail below and include
pneumonia, respiratory failure, acute respiratory distress syndrome
(ARDS), acute kidney injury, sepsis, myocardial injury, arrhythmias,
and blood clots. Among 35,302 inpatients in a nationwide U.S. study,
median length of stay was 6 days overall (Rosenthal, et al., December
10, 2020). When cases required treatment in the ICU, ICU stays were on
median 5 days in addition to time spent hospitalized outside of the
ICU. The Roth et al., (May 3, 2021) study described above reported that
mean length of hospital stays decreased from 10.7 days in April and May
2020 to 7.5 days from September to November 2020, and the respective
values for ICU stays over the same time period decreased from 13.9 days
to 6.6 days. As discussed
in more detail above, improvements in infection control and treatment
interventions might be responsible for the improved outcome, but the
specific reason is not known, and the numbers of individuals
hospitalized with COVID-19 remains high.
The pneumonia associated with the SARS-CoV-2 virus can become
severe, resulting in respiratory failure and ARDS, a life-threatening
lung injury. In a U.S. study of 35,302 COVID-19 inpatients, 55.8%
suffered respiratory failure with 8.1% experiencing ARDS (Rosenthal, et
al., December 10, 2020). Thus, the need for oxygen therapy is a key
reason for hospitalization. The specific therapy received during
hospitalization often depends on the severity of lung distress and can
include supplemental oxygen, noninvasive ventilation, intubation for
invasive mechanical ventilation, and extracorporeal membrane
oxygenation when mechanical ventilation is insufficient (NIH, April 21,
2021a).
Although COVID-19 was initially considered to be primarily a
respiratory disease, adverse effects in numerous organs have now been
reported. For example, in a New York City area study of 9,657 COVID-19
patients, 39.9% of patients developed acute kidney injury (AKI), a
sudden episode of kidney failure or kidney damage; of the approximately
40% of patients who developed AKI, 17% required dialysis (Ng et al.,
September 19, 2020). AKI similarly occurred in 33.9% of 35,302
inpatients in a nationwide U.S. study (Rosenthal et al., December 10,
2020). For patients who experience AKI associated with COVID-19, a
study of patients in the New York area reported a median length of stay
in the hospital of 11.6 days for patients who did not require dialysis,
but for those who did, the median length of stay almost tripled to 29.2
days (Ng et al., September 19, 2020). Many critically ill COVID-19
patients require renal replacement therapy (NIH, April 21, 2021a). For
example, one study including 67 U.S. hospitals found that 20.6% of
critically ill COVID-19 patients developed AKI that requires renal
replacement therapy (Gupta et al., 2021).
COVID-19 is also capable of causing viral sepsis, a condition where
the immune response dysregulates and causes life-threatening harm to
organs (e.g., lungs, brain, kidneys, heart, and liver). In Rosenthal et
al.'s, (December 10, 2020) U.S. study through May 31, 2020, 33.7% of
COVID-19 inpatients developed sepsis. A study of 18-49 year olds in the
COVID-NET surveillance system found that 16.6% of patients in that age
range developed sepsis (Owusu et al., December 3, 2020). In a study of
VA hospitals, sepsis was found to be the most common complication that
resulted in readmission within 60 days of being discharged (Donnelly et
al., January 19, 2020).
COVID-19 patients have also been reported to experience a number of
adverse cardiac complications, including arrhythmias, myocardial injury
with elevated troponin levels, and myocarditis (Caforio, December 2,
2020). Acute ischemic heart disease occurred in 8% of 35,302 inpatients
in a nationwide U.S. study (Rosenthal et al., December 10, 2020).
Patients hospitalized with COVID-19 may also experience shock, a
critical condition caused by a sudden drop in blood pressure that can
lead to fatal cardiac complications. Shock occurred in 4,028 of 35,302
(11.4%) inpatients in a nationwide U.S. study (Rosenthal et al.,
December 10, 2020). And a study of 70 COVID-19 patients in a Freiburg
ICU found that shock was a complicating factor in 24% of fatal cases
(Rieg et al., November 12, 2020). A New York City area study reported
that 21.5% of the study's 9,657 patients experience serious drops in
blood pressure that required medical intervention during their hospital
stay (Ng et al., September 19, 2020).
In addition to its adverse effects on specific organs, COVID-19 may
cause patients to develop a hypercoagulable state, a condition in which
blood clots can develop in someone's legs and embolize to their lungs,
further worsening oxygenation. Blood clots in COVID-19 patients have
also been reported in arteries, resulting in strokes--even in young
people--as well as heart attacks and acute ischemia from lack of oxygen
in limbs in which arterial clots have occurred (Cuker and Peyvandi,
November 19, 2020; Oxley et al., May 14, 2020). Blood clots have been
reported even in COVID-19 patients on prophylactic-dose
anticoagulation. A systematic review of more than 28,000 COVID-19
patients found that venous thromboembolism (deep vein thrombosis,
pulmonary embolism or catheter-related thrombosis) occurred in 14% of
hospitalized patients overall and 22.7% of ICU patients (Nopp et al.,
September 25, 2020). Pulmonary embolism was reported in 3.5% of non-ICU
and 13.7% of ICU patients. Embolism and thrombosis can cause death.
COVID-19 poses such a threat of blood clots that NIH guidelines now
recommend that hospitalized non-pregnant adults with COVID-19 should
receive prophylactic dose anticoagulation (NIH, April 21, 2021a).
These health effects are particularly relevant to healthcare
workers because there is evidence that healthcare workers are more
likely to develop more severe COVID-19 symptoms than workers in non-
healthcare settings. While the reason for this is not certain, one
cause could be that healthcare workers are exposed to higher viral
loads (more viral particles entering the body) because of the nature of
their work often involving frequent and sustained close contact with
COVID-19 patients. For example, a British study compared healthcare
workers to other ``essential'' and ``non-essential'' workers and found
that healthcare workers were more than 7 times as likely to experience
severe COVID-19 disease following infection (i.e., disease requiring
hospitalization) than infected non-essential workers (Mutambudzi et
al., 2020).
Mild to Moderate Cases of COVID-19
Even the less severe health effects of COVID-19 cover a wide range
of symptoms and severity, from serious illness to milder symptomatic
illness to asymptomatic cases. The most common symptoms include fever
or chills, cough, shortness of breath or difficulty breathing, fatigue,
muscle or body aches, headache, developing a loss of taste or smell,
sore throat, congestion or runny nose, nausea, vomiting, and/or
diarrhea (CDC, February 22, 2021).
Approximately 80% of symptomatic COVID-19 cases are mild to
moderate (Wu and McGoogan, April 7, 2020), which is defined as having
any symptom of COVID-19 but without substantially decreased oxygen
levels, shortness of breath, or difficulty breathing (NIH, April 21,
2021b). Moderate cases, however, also show evidence of lower
respiratory disease, although these cases largely do not require
admission into hospitals (CDC, February 16, 2021). While deaths and
severe health consequences of COVID-19 are sufficiently robust in
support of OSHA's finding that COVID-19 presents a grave danger, even
many of the typical mild or moderate cases surpass the Florida Peach
Growers threshold of ``fleeting effects . . . so minor that they often
went unreported'' (supra). Mild and moderate cases can be treated at
home but may still require medical intervention (typically through
telehealth visits) (Wu and McGoogan, April 7, 2020). Individuals with
mild cases often need at least one to two weeks to recover enough to
resume work, but effects can potentially last for months. Fatigue,
headache, and muscle aches are among the most commonly-reported
symptoms in people who are
not hospitalized (CDC, February 16, 2021), and their effects are not
fleeting and often linger. In a multistate telephone survey of 292
adults with COVID-19, the majority of whom did not eventually require
hospitalization, 274 (94%) of the survey respondents were symptomatic
at the time of their SARS-CoV-2 test, reporting illness for a median of
three days prior to the positive test (Tenforde et al., July 24, 2020).
Around one third of symptomatic respondents (95 of 274) reported that
they still had not returned to their usual state of health 2-3 weeks
after testing positive. Even among the young adults (aged 18-34 years)
with no chronic medical conditions, nearly one in five had not returned
to their usual state of health 2-3 weeks after testing.
Even though these cases rarely result in hospitalization,
individuals with mild to moderate cases of COVID-19 are also
significantly impacted by their illness as a result of CDC isolation
recommendations. According to the current CDC criteria, a person with
symptomatic COVID-19 should generally discontinue isolation only when
all three of the following conditions have been met: (1) At least 10
days have passed since symptom onset; (2) at least 24 hours have passed
since experiencing a fever without the use of fever-reducing
medications; and (3) other symptoms have improved (other than loss of
taste or smell) (CDC, February 18, 2021). And the CDC notes with
respect to the first criteria that individuals with severe illness or
with compromised immunity might require up to 20 days of isolation.
Even those with mild or moderate cases of COVID-19 may be prevented by
their illness from working from home during the period of isolation.
Longer-Term Health Effects
Recovery from acute infection with the SARS-CoV-2 virus can be
prolonged. Three categories of patients in particular are known to
require ongoing care after resolution of their acute viral infection:
Those with a severe illness requiring hospitalization (especially ICU
care); those with a specific medical complication from the infection,
such as a stroke; and those with milder acute illnesses who experience
persistent symptoms such as fatigue and breathlessness. The lingering
of, or development of, related health effects after a SARS-CoV-2
infection is known as post-acute sequelae. Dr. Francis Collins,
Director of the National Institutes of Health, testified that recovery
can be prolonged even in previously healthy young adults with milder
infections. Some people experience persistent symptoms for weeks or
even months after the acute infection (Collins, April 28, 2021). Post-
Acute COVID-19 syndrome has been proposed as a diagnostic term for
these patients, although the term ``long COVID'' is more common outside
the medical community. According to the CDC, the most common symptoms
of Post-Acute COVID-19 syndrome are fatigue, shortness of breath,
cough, and joint and chest pain (CDC, April 8, 2020). Other symptoms
reported by these patients include decreased memory and concentration,
depression, muscle pain, headache, intermittent fever, and racing heart
(CDC, April 8, 2021). Additional common symptoms, as reported by Dr.
Collins, are abnormal sleep patterns and persistent loss of taste or
smell (Collins, April 28, 2021). The cause of these long-term effects
and effective treatments have yet to be established. The report from
the Pulmonary Breakout Session of the National Institute of Allergy and
Infectious Diseases (NIAID) Workshop on Post-Acute Sequelae of COVID-19
stated that the ``burden of post-acute sequelae overall could be
enormous'' (NIAID, December 4, 2020). Dr. John Brooks, the chief
medical officer for the CDC's COVID-19 response, said he expected long-
term symptoms would affect ``on the order of tens of thousands in the
United States and possibly hundreds of thousands'' (Belluck, December
5, 2020). Dr. Collins testified that longer-term health impairments may
occur in up to 30% of recovered COVID-19 patients (Collins, April 28,
2021).
Prolonged illness is common in patients who required
hospitalization because of COVID-19, and particularly in those who
required ICU admission. In a large nationwide U.S. study, 18.5% of
hospitalized patients were discharged to a long-term care or
rehabilitation facility (Rosenthal et al., December 10, 2020). Of 1,250
patients in a Michigan study, 12.6% were discharged to a skilled
nursing or rehabilitation facility and 15.1% of hospital survivors were
re-hospitalized within 60 days of discharge (Chopra et al., November
11, 2020). Of the 195 who were employed prior to hospitalization, 23%
were unable to return to work due to health reasons and 26% of those
who returned to work required reduced hours or modified duties (Chopra
et al., November 11, 2020). Those who returned to work did so a median
of 27 days after hospital discharge (Chopra et al., November 11, 2020).
Existing evidence indicates that COVID-19 patients requiring ICU care
and mechanical ventilation may experience Post Intensive Care Syndrome
(PICS), which is a constellation of cognitive dysfunction, psychiatric
conditions, and/or physical disability that persists after patients
leave the ICU (Society of Critical Care Medicine, 2013). In a study at
3 months post-discharge of 19 COVID-19 patients who required mechanical
ventilation while hospitalized, 89% reported pain or discomfort, 47%
experienced decreased mobility, and 42% experienced anxiety/depression
(Valent, October 10, 2020). The authors noted that these results are
similar to those reported in follow-up studies of patients who survived
ARDS due to other viral infections. Many employees hospitalized with
COVID-19 may require a long period of recovery should this trajectory
continue to hold. In a 5-year follow-up of 67 previously-employed ARDS
survivors, 34 had not returned to work within one year of discharge and
21 had not returned at five years (Kamdar, February 1, 2018). ARDS is a
serious complication that may have an impact on employees' ability to
return to work after a COVID-19 diagnosis.
Several studies conducted outside the U.S. have also noted the
persistence of COVID-19 symptoms after hospital discharge. In a study
of 1,733 discharged patients in China, 76% reported at least one
symptom of COVID-19 six months after hospital discharge with 63%
experiencing persistent fatigue or muscle weakness (Huang et al.,
January 8, 2021). Similarly, an Irish study found 52% of 128 patients
reported persistent fatigue a median of 10 weeks after initial symptoms
first appeared (Townsend et al., November 9, 2020). A study of 991
pregnant women (5% hospitalized) in the U.S. found that the median time
for symptoms to resolve was 37 days and that 25% had persistent
symptoms (mainly cough, fatigue, headache, and shortness of breath)
eight weeks after onset (Afshar et al., December, 2020). A study of 86
previously-hospitalized Austrian patients observed that 88% had CT
scans still indicating lung damage at 6 weeks after their hospital
discharge; at 12 weeks, 56% of CT scans still revealed damage (European
Respiratory Society, September 7, 2020). A study of 152 previously-
hospitalized patients with laboratory-confirmed COVID-19 disease who
required at least 6 liters of oxygen during admission found that 30 to
40 days after discharge, 74% reported shortness of breath and 13.5%
still required oxygen at home (Weerahandi et al., August 14, 2020). A
UK study found that among 100
hospitalized patients (32% required ICU care), 72% of the ICU patients
and 60% of the non-ICU patients reported fatigue a mean of 48 days
after discharge (Halpin et al., July 27, 2020). Breathlessness was also
common, affecting 65.6% of ICU patients and 42.6% of non-ICU patients.
In a New York City study, of the 638 COVID-19 patients who required
dialysis for AKI while hospitalized, only 108 survived. Of those 108,
33 still needed dialysis at discharge (Ng et al., September 19, 2020).
A study of Chinese patients reported that 11% of 333 hospitalized
patients with COVID-19 pneumonia developed AKI (Pei et al., June,
2020). Only half (45.7%) experienced complete recovery of kidney
function with a median follow up of 12 days. A similar study in Spain
also found only half (45.72%) experienced complete recovery with a
median follow up of 11 days (Procaccini et al., February 14, 2021). A
Hong Kong study provided a longer follow-up period including 30 and 90
days after the initial AKI event. At 7, 30, and 90 days after the
initial AKI event, recovery was observed in 84.6, 87.3% and 92.1%,
respectively (Teoh et al., 2021). A study in New York City found that
77.1% of patients with AKI experienced complete recovery during the
follow up period, excluding those who died or were sent to hospice
(Charytan et al., January 25, 2021). While 88% of these AKI cases were
in March and April with a final follow-up date of August 25, it is
uncertain how long it took for recovery to occur.
Long-term cardiovascular effects also appear to be common after
SARS-CoV-2 infections, even among those who did not require hospital
care. A German study evaluated the presence of myocardial injury in 100
patients a median of 71 days after COVID-19 diagnosis (Puntmann et al.,
July 27, 2020). While only a third (33%) of study participants required
hospitalization, cardiovascular magnetic resonance (CMR) imaging was
abnormal in 78%. In the U.S., a study of COVID-19 cases in college
athletes, of whom 16 of 54 (30%) were asymptomatic, identified abnormal
findings in 27 (56.3%) of the 48 athletes who completed both imaging
studies, with 39.5% consistent with resolving pericardial inflammation
(Brito et al., November 4, 2020). A small number remained symptomatic
with fatigue and shortness of breath at 5 weeks and were referred to
cardiac rehabilitation (Lowry, November 12, 2020).
A database for clinicians in the UK to report COVID-19 patients
with neurological complications revealed that 62% of the initial 125
patients enrolled presented with a cerebrovascular event including
ischemic strokes and intracerebral hemorrhages (Varatharaj et al., June
25, 2020). A UK study comparing COVID-19 ischemic stroke and
intracerebral cases with similar non-COVID-19 cases found a fatality
rate of 19.8% for COVID-19 patients in comparison to a fatality rate of
6.9% for non-COVID-19 patients (Perry et al., 2021). As discussed
above, PICS, involving prolonged impairments in cognition, physical
health, and/or mental health, may also occur. Other neurologic
diagnoses, including encephalopathy, Guillain-Barre syndrome, and a
range of other less-common diagnoses, may cause morbidity that persists
during recovery (Elkind et al., April 9, 2021; Sharifian-Dorche et al.,
August 7, 2020). A recent autopsy study of brain tissue from 18 COVID-
19 patients reported the presence of small blood vessel inflammation
and damage in multiple different brain areas (Lee et al., February 4,
2021). Persistent abnormalities in brain imaging have also been
reported in patients after discharge (Lu et al., August 3, 2020). A
study of 509 hospitalized patients in the Chicago area early in the
pandemic reported that a third had encephalopathy, resulting in
symptoms such as confusion or decreased levels of consciousness (Liotta
et al., October 5, 2020). Encephalopathy was associated with worse
functional outcomes at discharge (only 32% were able to handle their
own affairs without assistance) and higher deaths in the 30 days post-
discharge.
COVID-19 also impacts mental health, both as a result of the toll
of living and working through such a disruptive pandemic, but also
because of actual medical impacts the virus might have on the brain
itself. As de Erausquin et al., (January 5, 2021) notes, SARS-CoV-2 is
a suspected neurotropic virus and ``neurotropic respiratory viruses
have long been known to result in chronic brain pathology including
emerging cognitive decline and dementia, movement disorders, and
psychotic illness. Because brain inflammation accompanies the most
common neurodegenerative disorders and may contribute to major
psychiatric disorders, the neurological and psychiatric sequelae of
COVID[hyphen]19 need to be carefully tracked.'' An international
consortium guided by WHO is attempting to determine these long-term
neurodegenerative consequences more definitively, with follow up
studies ending in 2022 (de Erausquin et al., January 5, 2021).
In the short term, a number of studies have already demonstrated
the potential mental health effects caused by COVID-19. In the UK
database mentioned above, 21 of 125 COVID-19 patients had new
psychiatric diagnoses, including 10 who became psychotic and others
with dementia-like symptoms or depression (Varatharaj et al., June 25,
2020). An Italian study screened 402 adults with COVID-19 for
psychiatric symptoms with clinical interviews and self-report
questionnaires at one month follow-up after hospital treatment for
COVID-19. Patients rated in the psychopathological range as follows:
28% for post-traumatic stress disorder (PTSD), 31% for depression, 42%
for anxiety, 20% for obsessive-compulsive symptoms, and 40% for
insomnia. Overall, 56% scored in the pathological range in at least one
clinical dimension (Mazza et al., July 30, 2020). The TriNetX analytics
network was used to capture de-identified data from electronic health
records of a total of 69.8 million patients from 54 healthcare
organizations in the United States (Taquet et al., November 9, 2020).
Of those patients, 62,354 adults were diagnosed with COVID-19 between
January 20 and August 1, 2020. Within 14 to 90 days after being
diagnosed with COVID-19, 5.8% of those patients received a first
recorded diagnosis of psychiatric illness, which was measured as
significantly greater than psychiatric onset incidence during the same
time period after diagnoses of other medical issues including influenza
(2.8%), other respiratory diseases (3.4%), skin infections (3.3%),
cholelithiasis (3.2%), urolithiasis (2.5%), and fractures (2.5%). At
the NIAID Workshop on Post-Acute Sequelae of COVID-19, medical
personnel discussed their experiences treating COVID-19 patients in the
Johns Hopkins Post-Acute COVID-19 Team (PACT) Clinic. Among 49 patients
in the Clinic, more than 50% had some form of cognitive impairment 3
months after acute illness (Parker, December 3, 2020). Both ICU and
non-ICU patients were affected, but impairment was more pronounced in
ICU survivors (Parker, December 3, 2020). The medical personnel also
reported mental health impairments among patients treated at the PACT
Clinic.
The studies and evidence discussed above give some indication of
the many serious long-term health effects COVID-19 patients might
experience, including respiratory, cardiovascular, neurological, and
psychiatric complications. However, the full extent of the long-term
health consequences of COVID-19 is unknown because the
virus has only been transmitted between humans since the end of 2019.
Therefore, to fully appreciate the likely long-term risks to
individuals with COVID-19, it is important to consider the long-term
impacts of similar coronaviruses found among human populations where
there has been more time to gather data.
The previous SARS outbreak in 2002 to 2003, caused by the SARS-CoV-
1 virus, is one such example, and it indicates long-term impacts to
infection survivors, which might result from the viral infection,
medications used, or a combination of those factors. Patients who
survived a SARS-CoV-1 infection report that they have a reduced quality
of life at least 6 months after illness (Hui et al., October 1, 2005).
These patients were found to have reduced exercise capacity; some had
abnormal chest radiographs and lung function, and weak respiratory
muscles at least 6 months after illness (Hui et al., October 1, 2005).
Survivors reported experiencing depression, insomnia, anxiety, PTSD,
chronic fatigue, and decreased lung capacity with patient follow up as
long as four years after infection (Lam et al., December 14, 2009; Lee
et al., April 1, 2007; Hui et al., October 1, 2005). Long term studies
have revealed that some survivors of SARS-CoV-1 infections have chronic
pulmonary and skeletal damage after a 15 year follow up (Zhang et al.,
February 14, 2020). Zhang et al., found that approximately half of the
area of ground glass opacities present after infection in a 2003 CT
scan (9.4%) remained after 15 years (4.6%). The study also found
significant femoral head loss (25.52%) remained in 2018. Bone loss was
likely an indirect effect caused by the high pulse steroid therapies
used to treat the infection in many patients with severe disease.
Survivors also suffer long-term neurologic complications, deficits in
cognitive function, musculoskeletal pain, fatigue, depression, and
disordered sleep up to at least three years after infection (Moldofsky
and Patcai, March 24, 2011).
Individuals at Increased Risk From COVID-19
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. Comorbidities are fairly 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).
Furthermore, over a quarter of those between 65 and 74 years old remain
in the workforce, as well as almost 10% of those 75 and older (BLS, May
29, 2019). In hospitals and other health services (e.g., physician
offices, residential care facilities), 1,078,000 workers are employed
who are 65 years old and older (BLS, January 22, 2021). Individuals who
are at increased risk of severe infection (hospitalization, admission
to the ICU, or death) include: Individuals who have cancer, chronic
kidney disease, chronic lung disease (e.g., chronic obstructive
pulmonary disease (COPD), asthma (moderate-to-severe), interstitial
lung disease, cystic fibrosis, and pulmonary hypertension), serious
heart conditions, obesity, pregnancy, sickle cell disease, type 2
diabetes, and individuals who are over 65 years of age,
immunocompromised and/or smokers (CDC, May 13, 2021). Of 5,700 COVID-19
patients hospitalized from March 1 to April 4, 2020 in the New York
City area, the most common comorbidities were hypertension (56.6%),
obesity (41.7%), and diabetes (33.8%), excluding age (Richardson et
al., April 22, 2020).
Observed Disparities in Risk Based on Race and Ethnicity
During the COVID-19 pandemic, research has found that employees in
racial and ethnic minority groups, and especially Black and Latinx
employees, have often faced substantially higher risks of SARS-CoV-2
exposure and infection through the workplace than have non-Hispanic
White employees (Hawkins, June 15, 2020; Hertel-Fernandez et al., June
2020; Roberts et al., November 26, 2020). Among the general U.S.
population, American Indian, Alaskan Native, Latinx, and Black
populations are more likely than White populations to be infected with
SARS-CoV-2 (CDC, April 23, 2021). Once infected, people in these
demographics are also more likely than their White counterparts to be
hospitalized for and/or die from COVID-19 (CDC, April 23, 2021). These
observed disparities in risk of infection, risk of adverse health
consequences, and risk of death may be attributable to a number of
factors, including that people from racial and ethnic minority groups
are often disproportionately represented in essential frontline
occupations that require close contact with the public and that offer
limited ability to work from home or take paid sick days. Disease
severity is also likely exacerbated by long-standing healthcare
inequities (CDC, April 19, 2021).
Hawkins (June 15, 2020) compared data on worker demographics from
the Bureau of Labor Statistics' 2019 Current Population Survey and
O*NET (a Department of Labor database that contains detailed
occupational information on the nature of work for more than 900
occupations across the U.S.) to determine occupation-specific COVID-19
risks. The model found that among O*NET's 57 physical and social
factors related to work, the two predictive variables of COVID-19 risk
were frequency of exposure to diseases and physical proximity to other
people. The author found that Black individuals were overwhelmingly
employed in essential industries and that people of color--which in
this study included Black, Asian, and Hispanic populations--were more
likely than White individuals to work in essential occupations (e.g.,
healthcare and social assistance, personal care aids) that were
identified as having greater disease exposure risk characteristics. A
similar evaluation of workers employed in frontline industries (e.g.,
healthcare) found that people of color--defined in this study to
include individuals who are Black, Hispanic, Asian-American/Pacific
Islander, or some category other than White--are well represented in
these types of work (Rho et al., April 7, 2020). These studies suggest
that people in racial and ethnic minority groups are greatly
represented among the American workforce in jobs associated with
greater risk of exposure to SARS-CoV-2, including those in healthcare
and related industries.
Through April 2021, infection rates compared to White, Non-Hispanic
persons in the United States are 60% greater for American Indian or
Alaskan Native persons, 100% greater for Latinx persons, and 10%
greater for Black persons (CDC, April 23, 2021). This disparity is also
reflected in studies addressing infections by occupation, race, and
ethnicity. In a large study of healthcare employees in Los Angeles,
researchers found that increased risk of infection was significantly
related to whether an employee was Latinx or Black (Ebinger et al.,
February 12, 2021). Another study of frontline healthcare workers in
the U.S. and UK found that Black, Asian, and minority ethnic workers
were more likely to report a positive COVID-19 test than non-Hispanic,
White workers (Nguyen et al., September 1, 2020). The study also found
that Black, Asian, and minority ethnic healthcare workers were more
likely to report reuse of or inadequate PPE, were more likely to work
in higher-risk clinical settings (e.g., in-patient hospitals or nursing
homes), and were more likely to care for patients with
suspected or documented COVID-19. These studies illustrate that racial
and ethnic minorities are likely to be at increased risk of
occupational SARS-CoV-2 exposures and related infections.
In addition to an increased likelihood of exposures and potential
infection, Native American, Alaskan Native, Latinx, and Black
populations all have increased risk of hospitalization and/or death
from COVID-19 in comparison to White populations (CDC, April 23, 2021).
Chen et al., (January 22, 2021) studied increased mortality risk
between different racial and ethnic minority groups and occupations for
working age Californians in pre-pandemic and pandemic time frames.
Measured mortality risks increased during the pandemic for all races
and ethnicities, but White populations had lower increased risk (6%
increase) compared to Asian populations (18%), Black populations (28%)
and Latinx populations (36%). A similar disparity in excess mortality
was also observed between races and ethnicities within the same
occupational sector (Chen et al., January 22, 2021). In the ``health or
emergency'' sector, risk ratios were far greater for Asian (1.40),
Black (1.27), and Latinx (1.32) workers in comparison to White workers
(1.02).
Health equity is a major concern in assessing the pandemic's
effects (CDC, April 19, 2021). Some of the factors that contribute to
increased risk of morbidity and mortality from COVID-19 include:
Discrimination, healthcare access/utilization, economic issues, and
housing (CDC, April 23, 2021). And although racial and ethnic minority
groups are more likely to be exposed to and infected with SARS-CoV-2,
research indicates that testing for the virus is not markedly higher
for these demographic groups (Rubin-Miller et al., September 16, 2020).
Rubin-Miller et al., note that there may be barriers to testing that
decrease access or delay testing to a greater degree than in White
populations. These barriers to testing can delay needed medical care
and lead to worse outcomes. And even when able to seek care, other
barriers may exist. In discussing widespread health inequities, studies
have noted that American Indian communities lacked sufficient
facilities to respond to COVID-19 (Hatcher et al., August 28, 2020; van
Dorn et al., April 18, 2020).
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b. Transmission of SARS-CoV-2
SARS-CoV-2 is a highly transmissible virus. Since the first case
was detected in the U.S., there have been over 32 million reported
cases of COVID-19, affecting every state and territory, with thousands
more infected each day. 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).\8\ 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, May, 2021).
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\8\ On May 7, 2021, the CDC updated its guidance regarding
airborne transmission (CDC, May 7, 2021; https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html). OSHA notes that this change does not alleviate
the need for any of the controls in this ETS. Because OSHA has
determined that the controls in this ETS are necessary to address a
grave danger as quickly as possible, the agency determined that it
was appropriate to issue the ETS while it continues to evaluate the
new evidence to determine whether additional controls may be
necessary at a later date.
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The best available current scientific evidence demonstrates that
the farther a person is away from the source of the respiratory
droplets, the fewer infectious viral particles will reach that person's
eyes, nose, or mouth because gravity pulls the droplets to the ground
(see the Need for Specific Provisions, Section V of the preamble, on
Physical Distancing). For example, a systematic review of SARS-CoV-2
(up to early May 2020) and similar coronaviruses (i.e., SARS-CoV-1 (a
virus related to SARS-CoV-2) and Middle Eastern Respiratory Syndrome
(MERS) (a disease caused by a virus that is similar to SARS-CoV-2 and
spreads through droplet transmission)) found 38 studies, containing
18,518 individuals, to use in a meta-analysis that found that the risk
of viral infection decreased significantly as distance increased (Chu
et al., June 27, 2020). A second COVID-19 study from Thailand reviewed
physical distancing information collected from 1,006 individuals who
had an exposure to infected individuals (Doung-ngern et al., September
14, 2020). The study revealed that the group with direct physical
contact and the group within one meter but without physical contact
were equally likely to become infected with SARS-CoV-2. However, the
group that remained more than one meter away had an 85% lower infection
risk than the other two groups. The studies' findings on physical
distancing combined with expert opinion firmly establish the importance
of droplet transmission as a driver of SARS-CoV-2 infections and COVID-
19 disease.
COVID-19 may also be spread through airborne particles under
certain conditions (Schoen, May 2020; CDC, May 7, 2020; Honein et al.,
December 11, 2020). That airborne transmission can occur during
aerosol-generating procedures (AGPs) in healthcare (such as when
intubating an infected patient) is a reasonable concern (see CDC, March
12, 2020). CDC provides recommendations for infection prevention and
control practices when caring for a patient with suspected or confirmed
SARS-CoV-2 infection that include the use of a respirator (CDC,
February 23, 2021). There are several studies examining the risks
associated with AGPs. For example, a publication detailing one of the
first known SARS-CoV-2 occupational transmission events in U.S.
healthcare providers reported a statistically significant increased
risk from AGPs (Heinzerling et al., April 17, 2020). However, the
currently available information specifically related to SARS-CoV-2
exposure during AGPs is limited (Harding et al., June 1, 2020).
Data from the Respiratory Protection Effectiveness Trial (ResPECT),
designed to assess effectiveness of PPE to prevent respiratory
infections, were analyzed to identify risk factors for endemic
coronavirus infections among healthcare personnel (Cummings et al.,
July 9, 2020). This study found that AGPs may double the risk of
infection among healthcare providers. Although the infectious agents
studied were surrogate coronaviruses and not the SARS-CoV-2 virus, the
study indicates increased risk from such procedures for infections from
the coronavirus family, and thus the study is relevant. In addition, a
systematic review of research on transmission of acute respiratory
infections from patients to healthcare employees focused on
publications from the first SARS virus outbreak (Tran et al., April 26,
2012). Risks of SARS-CoV-1 infection in those performing AGPs were
several times higher than in healthcare workers not exposed to AGPs.
Workers may also be exposed to the SARS-CoV-2 virus during AGPs
conducted outside of the hospital setting, including certain dental
surgical procedures (Leong et al., December 2020), cardiopulmonary
resuscitation (CPR) provided by homecare workers (Payne and Peache,
February 4, 2021), and endoscopy (Teng et al., September 16, 2020;
Sagami et al., January 2021).
Risk from AGPs during autopsies is evident from reports of staff
infections during autopsies on decedents infected with tuberculosis,
which is a well-known airborne infectious agent (Nolte et al., December
14, 2020). Additionally, research that measured airborne particles
released during the use of an oscillating saw with variable saw blade
frequencies and different saw blade contact loads concluded that, even
in the best-case scenario tested on dry bone, the number of aerosol
particles produced was still high enough to provide a potential health
risk to forensic practitioners (Pluim et al., June 6, 2018). Other
reports from healthcare settings have raised the possibility of spread
of airborne particles from suspected or confirmed COVID-19 patients,
absent AGPs. For example, infectious viral particles were collected
from in the room of a COVID-19 patient from distances as far as 4.8
meters away in non-AGP hospital settings (Lednicky et al., September
11, 2020), and transmission via aerosol was suspected in a
Massachusetts hospital (Klompas et al., February 9, 2021). For more
discussion of this subject, see the Need for Specific Provisions
(Section V of the preamble) on Respirators.
The extent to which COVID-19 may spread through airborne particles
in other contexts is less clear. CDC has noted that in some
circumstances airborne particles can remain suspended in the air and be
breathed in by others, and travel distances beyond 6 feet (for example,
during choir practice, in restaurants, or in fitness classes) in
situations that would not be defined as involving close contact:
With increasing distance from the source, the role of inhalation
likewise increases. Although infections through inhalation at
distances greater than six feet from an infectious source are less
likely than at closer distances, the phenomenon has been repeatedly
documented under certain preventable circumstances. These
transmission events have involved the presence of an infectious
person exhaling virus indoors for an extended time (more than 15
minutes and in some cases hours) leading to virus concentrations in
the air space sufficient to transmit infections to people more than
6 feet away, and in some cases to people who have passed through
that space soon after the infectious person left.
(CDC, May 7, 2021).
In general, enclosed environments, particularly those without good
ventilation, increase the risk of airborne transmission (CDC, May 7,
2021; Tang et al., August 7, 2020; Fennelly, July 24, 2020). In one
scientific brief, CDC provides a basic overview of how airborne
transmission occurs in indoor spaces. Once respiratory droplets are
exhaled, CDC explains, they move outward from the source and their
concentration decreases through fallout from the air (largest droplets
first, smaller later) combined with dilution of the remaining smaller
droplets and particles into the growing volume of air they encounter
(CDC, May 7, 2020). Without adequate ventilation, continued exhalation
can cause the amount of infectious smaller droplets and particles
produced by people with COVID-19 to become concentrated enough in the
air to spread the virus to other people (CDC, May 7, 2020). For
example, an investigation of a cluster of cases among meat processing
employees in Germany found that inadequate ventilation within the
facility, including low air exchange rates and constant air
recirculation, was one key factor that led to transmission of SARS-CoV-
2 within the workplace (Gunther et al., October 27, 2020). An
epidemiological investigation of a cluster of COVID-19 cases in an
indoor athletic court in Slovenia demonstrated that the humid and warm
environment of the setting, combined with the turbulent air flow that
resulted from the physical activity of the players, allowed COVID-19
particles to remain suspended in the air for hours (Brlek et al., June
16, 2020). A cluster of cases in a restaurant in China also suggested
transmission of SARS-CoV-2 via airborne particles because of little
mixing of air throughout the restaurant (Li et al., November 3, 2020).
Infections have been observed with as little as five minutes of
exposure in an enclosed room (Kwon et al., November 23, 2020). Outdoor
settings (i.e., open air or structures with one wall) typically have a
lower risk of transmission (Bulfone et al., November 29, 2020), which
is likely due to increased ventilation with fresh air and a greater
ability to maintain physical distancing. For more discussion of this
subject, see the Need for Specific Provisions (Section V of the
preamble) on Ventilation.
Transmission of SARS-CoV-2 is also possible via contact
transmission (both direct contact as well as surface contact), though
this risk is generally considered to be low compared to other forms of
transmission (CDC, April 5, 2021). Infectious droplets produced by an
infected person can land on and contaminate surfaces. Surface, or
indirect, transmission can then occur if another person touches the
contaminated surface and then touches their own mouth, nose, or eyes
(CDC, April 5, 2021). Contact transmission can also occur through
direct contact with someone who is infectious. In direct contact
transmission, the hands of a person who has COVID-19 can become
contaminated with the virus when the person touches their face, blows
their nose, coughs, or sneezes. The virus can then spread to another
person through direct contact such as a handshake or a hug.
The risk posed by contact transmission depends on a number of
factors, including airflow and ventilation, as well as environmental
factors (e.g., heat, humidity), time between surface contamination and
a person touching those surfaces, the efficiency of transference of
virus particles, and the dose of virus needed to cause infection.
Studies show that the virus can remain viable on surfaces in
experimental conditions for hours to days, but that under typical
environment conditions 99% of the virus is no longer viable after three
days (Riddell et al., October 7, 2020; van Doremalen, April 16, 2020;
CDC, April 5, 2021). At this time, it is not clear what proportion of
SARS-CoV-2 infection are acquired through contact transmission and
infections can often be attributed to multiple transmission pathways.
In recognition of the potential for contact transmission, CDC
recommends cleaning, hand hygiene, and, under certain circumstances,
disinfection for helping to prevent transmission of SARS-CoV-2 (CDC,
May 17, 2020; CDC, April 5, 2021). These are long established
recommendations to prevent the transmission of viruses that cause
respiratory illnesses (Siegel et al., 2007). The potential for contact
transmission was demonstrated in one study that reviewed cleaning and
disinfection in households (Wang et al., May 11, 2020). The study found
that the transmission of SARS-CoV-2 to family members was 77% lower
when chlorine- or ethanol-based disinfectants were used on a daily
basis compared to use only once in two or more days, irrespective of
other protective measures taken such as mask wearing and physical
distancing. For more discussion of this subject, see the Need for
Specific Provisions (Section V of the preamble) on Cleaning and
Disinfection.
These methods of transmission are not mutually exclusive, and each
can present a risk to employees in healthcare settings. Based on these
methods of transmission, there are a number of factors--often present
in healthcare settings--that can increase the risk of transmission:
Indoor settings, prolonged exposure to respiratory particles, and lack
of proper ventilation (CDC, May 7, 2020). First, and most
significantly, healthcare employees in settings where patients with
suspected or confirmed COVID-19 receive treatment may be required to
have frequent close contact with infectious individuals, these settings
are typically not designed for physical distancing, and many areas in
these facilities are not ventilated for the purpose of minimizing
infectious diseases capable of droplet or airborne transmission.
Employees frequently touch shared surfaces and use shared items. Even
in healthcare settings where employees have their own offices or
equipment, they often share a number of common spaces with other
workers, including bathrooms, break rooms, and elevators. Based on
these characteristics, SARS-CoV-2 appears to be transmissible in
healthcare environments, a conclusion supported by existing data
(Howard, May 22, 2021). COVID-19 incidence rates have increased
significantly for adults of working age as the pandemic has progressed
in comparison with other age groups, with researchers noting that
occupational status might be a driver (Boehmer et al., September 23,
2020). Currently, case rates continue to be predominantly higher in
working age groups in comparison to children and those over the age of
65 (CDC, May 24, 2021).
Given the high transmissibility expected in healthcare
environments, the exposure risk that employees face is high. This risk
is related to some extent to viral prevalence, which refers to the
number of individuals in healthcare settings who may be infectious at
any moment. As explained below, current data indicates that viral
prevalence in the population is based on a number of factors, including
the virus's existing reproductive number, the prevalence of pre-
symptomatic and asymptomatic transmission, and the recent documentation
of mutations of the virus that appear to be more infectious.
The transmissibility of viruses is measured in part by their
reproductive number or ``R0.'' This number represents the average
number of subsequently-infected people (or secondary cases) that are
expected to occur from each existing case, which includes low
transmission events as well as super-spreading phenomenon. Thus, an R0
of ``1'' indicates that on average every one case of infection will
lead to one additional case. As long as a virus has an R0 of more than
1, it is expected to continue to spread throughout the population. The
observed R0 (also known as simply R) must be below 1 to prevent
sustained spread; such a reduction can be achieved through infection
control interventions (e.g., vaccination, non-pharmaceutical
interventions) that either reduce the susceptibility of the population
to the virus or reduce the likelihood of transmission within the
population (Delamater et al., 2019). During the early part of the
COVID-19 outbreak in China, before consistent protective measures were
put into place, the R0 for SARS-CoV-2 was estimated as 2.2 (Riou and
Althaus, January 30, 2020). Higher estimates of the R0 early in China
(5.7) have also been published (Sanche et al., April 7, 2020). R0
ranges from 2 to 5 have been published for earlier MERS and SARS-CoV-1
coronavirus outbreaks (WHO, May 2003; Choi et al., September 25, 2017).
Since the start of the COVID-19 pandemic, the R0 has varied depending
on the natural ebb and flow of rolling infection surges as well as the
fluctuating non-pharmaceutical interventions (NPIs) put in place, such
as face coverings, nonessential business shutdowns, and testing with
follow-up isolation and quarantining. The R0 value in the U.S. early in
the pandemic was estimated to be approximately 2 (Li et al., October
22, 2020), and this value has generally remained above 1 for the
country as a whole throughout the pandemic, with various states well
above and below this value at various times (Harvard Chan School of
Public Health, February 26, 2021; Shi et al., May 18, 2021).
Pre-symptomatic and asymptomatic transmission are significant
drivers of the continued spread of COVID-19 (Johansson et al., January
7, 2021). Individuals are considered most infectious in the 48 hours
before experiencing symptoms and during the first few symptomatic days
(Cevik et al., October 23, 2020). The time it takes for a person to be
infected and then transmit the virus to another individual is called
the serial interval. Several studies have indicated that the serial
interval for COVID-19 is shorter than the time for symptoms to develop,
meaning that many individuals can transmit SARS-CoV-2 before they begin
to feel ill (Nishiura et al., March 4, 2020; Tindale et al., June 22,
2020). It is also possible for individuals to be infected and
subsequently transmit the virus without ever exhibiting symptoms. This
is called asymptomatic transmission. As noted earlier, a recent meta-
analysis reviewed 13 studies in which the asymptomatic prevalence
ranged from 4% to up to 41% (Byambasuren et al., December 11, 2020).
The existence of both pre-symptomatic transmission and asymptomatic
infection and transmission pose serious challenges to containing the
spread of the virus. 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, perhaps because asymptomatic
persons are less likely to be aware of their infection and can
unknowingly continue to spread the disease to others. Similarly, pre-
symptomatic individuals can transmit the virus to others before they
know they are sick and should isolate, assuming they are aware of their
exposure. Existing evidence demonstrates that asymptomatic transmission
is a significant contributor to the spread of COVID-19 in the United
States. Johansson et al., (January 7, 2021) conducted a study 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 found 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 SARS-CoV-2 virus also regularly mutates over time into
different genetic variants. Many of these variants results in no
increase in transmission or disease severity. However, the CDC monitors
for variants of interest, variants of concern, and variants of high
consequence (CDC, May 5, 2021). A variant of interest is one ``with
specific genetic markers that have been associated with changes to
receptor binding, reduced neutralization by antibodies generated
against previous infection or vaccination, reduced efficacy of
treatments, potential diagnostic impact, or predicted increase in
transmissibility or disease severity'' (CDC, May 5, 2021). CDC-listed
variants of interest include strains first identified in the United
States (e.g., B.1.526, B.1.526.1), the United Kingdom (e.g., B.1.525),
and Brazil (e.g., P.2). A variant of concern is one 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, May 5, 2021). CDC-listed variants
of concern include strains first identified in the United States (e.g.,
B.1.427, B.1.429), United Kingdom (e.g., B.1.17), Brazil (e.g., P.1),
and South Africa (e.g., B.1.351). As of April 24, B.1.1.7 made up 60%
of infections in the United States (CDC, May 11, 2021). CDC notes that
B.1.1.7 is associated with a 50% increase in transmission, as well as
potentially increased incidence of hospitalizations and fatalities
(CDC, May 5, 2021). As new strains with increased transmissibility or
more severe effects enter the U.S. population, healthcare workers may
be among the first to be exposed to them when those who are infected
seek medical care (Howard, May 22, 2021).
OSHA also recognizes that reported cases of SARS-CoV-2 likely
undercount actual infections in the U.S. population. This finding is
based on seroprevalence data, which measure the presence of specific
antibodies in the blood that are typically developed when an individual
is infected with SARS-CoV-2. Reported cases, in contrast, are based on
COVID-19 tests that measure active infections. Recent reported case
numbers suggest that approximately 10% of the US population has been
infected. However, only seven states reported seroprevalence below 10%
(i.e., Alaska, Hawaii, Maine, New Hampshire, Oregon, Vermont,
Washington) and 23 states plus Washington DC and Puerto Rico exceeded
20% (CDC, May 14, 2021). The likely reason for this difference is that
serological tests measure antibodies in the blood that can be detected
for a longer period of time than can an active COVID-19 infection. As
such, serological testing may be able to detect past COVID-19
infections in individuals who never sought out a viral test. A sampling
of states from the Nationwide Commercial Laboratory Seroprevalence
Survey illustrates this (CDC, May 14, 2021). On March 30, 2021,
California had reported 3,564,431 cases, but seroprevalence estimates
indicate that there have been 7,986,000 cases in the state (95% CI:
7,023,000-8,965,000). Similarly, Texas has reported 2,780,903 cases,
but seroprevalence data indicate 6,692,000 cases (95% CI: 5,624,000-
7,819,000). Given the very real possibility of higher numbers of cases
than are reported in national case counts, the disease burden discussed
in this document may well be underestimated.
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(WHO, May 2003)
c. The Effect of Vaccines on the Grave Danger Presented by SARS-CoV-2
The development of safe and highly effective vaccines and the on-
going nation-wide distribution of these vaccines are encouraging
milestones in the nation's response to COVID-19. Although there was
initial uncertainty attached to the performance of authorized vaccines
outside of clinical trials, vaccines have been in use for several
months and they have proven effective in reducing transmission as well
as the severity of COVID-19 cases. Data now available clearly establish
that fully-vaccinated persons (defined as two weeks after the second
dose of the mRNA vaccines or two weeks after the single dose vaccine)
have a greatly reduced risk compared to unvaccinated individuals. This
includes reductions in deaths, severe infections requiring
hospitalization, and less severe symptomatic infections. The
combination of data from clinical trials and data from mass vaccination
efforts points increasingly to a significantly lower risk in settings
where all workers are fully vaccinated and are not providing direct
care for individuals with suspected or confirmed COVID-19. OSHA has
therefore determined that there is insufficient evidence in the record
to support a grave danger finding for employees in non-healthcare
workplaces (or discrete segments of workplaces) where all employees are
vaccinated. However, in healthcare settings where workers are
vaccinated, as discussed below, the best available evidence establishes
a grave danger still exists, given the greater potential for
breakthrough cases in light of the greater frequency of exposure to
suspected and confirmed COVID-19 patients in those settings (Birhane et
al., May 28, 2021). In addition, the best available evidence shows that
vaccination has not eliminated the grave danger in mixed healthcare
workplaces (i.e., those where some workers are fully vaccinated and
some are unvaccinated) or in those healthcare workplaces where no one
has yet been vaccinated.
The Effectiveness of Authorized Vaccines
There are currently three vaccines for the prevention of COVID-19
that have received EUAs from the FDA, allowing for their distribution
in the U.S.: The Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19
vaccine, and the Janssen COVID-19 vaccine. Pfizer-BioNTech and Moderna
are mRNA vaccines that require two doses administered three weeks and
one month apart, respectively. Janssen is a viral vector vaccine that
requires a single dose (CDC, April 2, 2021). The vaccines were shown to
greatly exceed minimum efficacy standards 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, as well as less
severe symptomatic infections.
As stated above, the three authorized vaccine were shown to be
highly efficacious in clinical trials. Clinical trial results are
commonly considered a best case scenario (e.g., conducted in relatively
young and healthy populations), while evidence from follow-up
observational studies provides insight on a more diverse population.
This essential data from observational studies in populations who were
vaccinated outside of clinical trials is emerging and shows that the
mRNA vaccines are highly effective. At this time, observational studies
for the single dose, viral vector vaccine are not available. Some of
the studies for mRNA vaccines examined high-risk populations, such as
healthcare workers. Thus, the degree of protection in these studies can
be extrapolated to a wide range of workplace settings in healthcare.
The results from these studies are very encouraging.
A study of 3,950 health care personnel, first responders, and other
essential workers who completed weekly SARS-CoV-2 testing for 13
consecutive weeks reported 90% effectiveness (95% confidence interval
[CI] = 68%-97%) after full vaccination with either mRNA vaccine
(Thompson et al., April 2, 2021). Still, 22.9% of PCR-confirmed
infections required medical care; these included two hospitalizations
but no deaths. A study of more than 8,000 individuals in the U.S.
general population found that two doses of either mRNA vaccine were
88.7% effective in preventing SARS-CoV-2 infection (Pawlowski et al.,
February 27, 2021). Similar to the above results in essential workers,
although breakthrough infection occurred, vaccinated patients in this
study who were subsequently diagnosed with COVID-19 had significantly
lower 14-day hospital admission rates than matched unvaccinated
participants (3.7% vs. 9.2%). Hall et al., (April 23, 2021), in a study
of U.K. healthcare workers with bi-weekly testing, documented an 85%
effectiveness of the Pfizer-BioNTech vaccine, though those authors
required only one week after dose two for classification as fully
vaccinated. Research from Israel provides additional evidence of high
effectiveness for the Pfizer-BioNTech vaccine (Dagan et al., February
24, 2021).
Data available regarding vaccine efficacy against some SARS-CoV-2
variants of concern illustrate that the vaccines remain effective at
reducing symptomatic infections. Two doses of the Pfizer-BioNTech
COVID-19 vaccine was highly effective (85-86%) against SARS-CoV-2
infection and symptomatic COVID-19 during a period when B.1.1.7 was the
predominant circulating strain in the UK (Hall et al., April 23, 2021).
In Israel, the Pfizer-BioNTech vaccine was 92% effective even with the
proportion of cases due to the B.1.1.7 becoming the dominant virus in
circulation towards the end of the evaluation period (Dagan et al.,
February 24, 2021). Another study testing the Pfizer-BioNTech COVID-19
vaccine found that it was equally capable of neutralizing the notable
variants from the United Kingdom and South Africa (Xie et al., February
8, 2021). This finding was then reflected in a Qatari study that found
that the Pfizer-BioNTech vaccine was not only effective at preventing
disease in people infected by those variants, but was observed as 100%
effective in preventing fatalities from COVID-19 (Abu-Raddad et al.,
May 5, 2021). The Janssen vaccine clinical trial was conducted during a
time in which SARS-CoV-2 variants were circulating in South Africa
(B.1.351 variant) and Brazil (P.2 variant). At 28 or more days past
vaccination, efficacy against moderate to severe/critical disease was
72% in the United States; 68% in Brazil; 64% in South Africa (FDA,
February 26, 2021). Although some studies have reported antibodies to
be less effective against the B.1.351 variant, antibody activity in
serum from vaccinated persons was generally higher than activity from
serum of persons who recovered from COVID-19 (CDC, April 2, 2021).
A major question not fully addressed in the original clinical
trials is whether vaccinated individuals can become infected and shed
virus, even if they are asymptomatic. Thompson et al., (April 2, 2021),
reported that 11% of the PCR-confirmed breakthrough infections in their
essential worker population were asymptomatic, indicating a concern for
asymptomatic transmission. However, this concern is based on studies
indicating asymptomatic transmission among unvaccinated individuals and
it is not known if this phenomena occurs in infected vaccinated
individuals. In the Moderna clinical trial, reverse transcription
polymerase chain reaction (RT-PCR) testing was performed on
participants at their second vaccination visit; asymptomatic positives
in the vaccinated group were less than half those in the placebo group
(Baden et al., December 30, 2020, supplemental files Table s18). In a
Mayo clinic study, an 80% reduction in risk of positive pre-procedural
screening tests was observed in patients tested after their second
vaccine dose (Tande et al., March 10, 2021). A study of more than
140,000 healthcare workers and their almost 200,000 household members
reported a 30% reduction in risk of documented COVID-19 cases in the
household members after the healthcare provider was fully vaccinated
(Shah et al., March 21, 2021). In the Israeli general population, the
estimated vaccine effectiveness for the asymptomatic infection proxy
group (infection without documented symptoms, which could have included
undocumented mild symptoms) was 90% at 7 or more days after the second
dose (Dagan et al., February 24, 2021). Preliminary data from Israel
suggest that people vaccinated with the Pfizer-BioNTech COVID-19
vaccine who develop COVID-19 have a four-fold lower viral load than
unvaccinated people (Levine-Tiefenbrun, February 8, 2021). As noted by
CDC (April 2, 2021), this observation may indicate reduced
transmissibility, because viral load is thought to be a major factor in
transmission (Marks et al., February 2, 2021).
The CDC has acknowledged that a ``growing body of evidence suggests
that fully vaccinated people are less likely to have asymptomatic
infection or transmit SARS-CoV-2 to others'' (CDC, April 2, 2021). The
decreased risk for infection, especially serious infection, combined
with decreased risk of transmission to others has allowed the CDC to
relax some recommendations for individuals who are in community or
public settings and who are fully vaccinated with one of the three FDA
authorized vaccines, as follows.
Quarantine is no longer required for fully vaccinated
individuals who remain asymptomatic following exposure to a COVID-19
infected person (CDC, May 13, 2021).
Testing following a known exposure is no longer needed for
a fully vaccinated person, as long as the individual remains
asymptomatic and is not in specific settings such as healthcare (CDC,
April 27, 2021a), non-healthcare congregate facilities (e.g.,
correctional and detention facilities, homeless shelters) or high-
density workplaces (e.g., poultry processing plants) (CDC, May 13,
2021).
In non-healthcare settings, fully vaccinated people no longer need
to wear a mask or physically distance, except where required by
federal, state, local, tribal, or territorial laws, rules, and
regulations, including local business and workplace guidance (CDC, May
13, 2021). In healthcare settings, the picture is more mixed. While the
CDC still recommends source controls for vaccinated healthcare workers
to protect unvaccinated people, it has relaxed several NPIs for health
care providers (HCP) in some circumstances. CDC has stated that ``fully
vaccinated HCP could dine and socialize together in break rooms and
conduct in-person meetings without source control or physical
distancing'' (CDC, April 27, 2021a). The CDC also recommends that fully
vaccinated HCP no longer need to be restricted from work after a high-
risk exposure, as long as they remain symptom-free (CDC, April 27,
2021a). Perhaps more significantly, while acknowledging the growing
body of evidence against SARS-CoV-2 transmission from vaccinated people
to unvaccinated people, the CDC has not identified evidence of a
substantial risk of such transmission even in healthcare settings.
Therefore, pending additional evidence of such transmission, the risk
of transmission from vaccinated healthcare workers to unvaccinated co-
workers does not appear to be high enough to warrant OSHA's imposition
of mandatory controls through an ETS to protect unvaccinated workers
from exposure to vaccinated workers.
On the other hand, HCP treating suspected and confirmed COVID-19
patients are expected to have higher exposures to the SARS-CoV-2 virus
than others in the workforce, because such work involves repeated
instances of close contact with infected patients (Howard, May 22,
2021). Exposure can be even higher in aerosol generating activities.
Indeed, one study reported higher infection rates among vaccinated HCWs
during a regional COVID-19 surge (Keehner et al., Mar. 23, 2021). Thus,
the CDC has not relaxed infection control practices or PPE intended to
protect HCP, including respirator use. (CDC, April 27, 2021a). NIOSH
has stated that the ``available evidence shows that healthcare workers
are continuing to become infected with SARS-CoV-2 . . . including both
vaccinated and unvaccinated workers, and the conditions for the
transmission of the virus exist at healthcare workplaces'' (Howard, May
22, 2021). The CDC has also indicated that it will continue ``to
evaluate the impact of vaccination; the duration of protection,
including in older adults; and the emergence of novel SARS-CoV-2
variants on healthcare infection prevention and control
recommendations'' (CDC, April 27, 2021a). OSHA, too, will continue to
monitor this issue and revise the ETS as appropriate.
Grave Danger Exists in Healthcare Workplaces Where Unvaccinated Workers
Are Present
The evidence shows that the advent of vaccines does not eliminate
the grave danger from exposure to SARS-CoV-2 in healthcare workplaces
where less than 100% of the workforce is fully vaccinated. Unvaccinated
workers can transmit the virus to each other and can become infected as
a result of exposure to persons with COVID-19 who enter the healthcare
facility. An outbreak of COVID-19 due to an unvaccinated, symptomatic
HCP was recently reported in a skilled nursing facility in which 90.4%
of residents had been vaccinated (Cavanaugh, April 30, 2021). The
outbreak, due to the R.1 variant, caused attack rates that were three
to four times higher in unvaccinated residents and HCPs as among those
who were vaccinated. Additionally, unvaccinated persons were
significantly more likely to experience symptoms or require
hospitalization. Therefore, unvaccinated employees at these workplaces
remain at grave danger of infection, along with the serious health
consequences of COVID-19, as discussed in the remainder of this
section.
Although the risk appears to be lower, breakthrough infections of
vaccinated individuals do occur, but the potential for secondary
transmission remains not fully substantiated. For instance, a small yet
significant portion of the population does not respond well to
vaccinations (Agha et al., April 7, 2021; Boyarsky et al., May 5, 2021;
Deepak et al., April 9, 2021; ACI, April 28, 2021) and may be as
vulnerable as unvaccinated individuals. These individuals could
potentially transmit the SARS-CoV-2 infection to unvaccinated
employees. In a California study, seven out of 4,167 fully vaccinated
health care workers experienced breakthrough infections (Keehner et
al., May 6, 2021). A similar study from the Mayo Clinic, included
44,011 fully vaccinated individuals with 30 breakthrough infections
being recorded (Swift et al., April 26, 2021). Of those breakthrough
cases, 73% were symptomatic. Secondary transmission was not evaluated
in the study. A nursing facility in Chicago found 22 possible
breakthrough cases of SARS-COV-2 infection among fully vaccinated staff
and residents (Teran et al., April 30, 2021). Of those cases, 36% were
symptomatic. However, no secondary transmission was observed in the
facility. The lack of secondary transmission was likely due to the
facility's implementation of non-pharmaceutical interventions and high
vaccination rates. The authors concluded that to ensure outbreaks do
not occur from breakthrough infections in workplaces with vaccinated
and unvaccinated workers that the facilities need to maintain high
vaccine coverage and non-pharmaceutical interventions. While these
breakthrough events appear to be uncommon, it is important to remember
how quickly a few cases can result in an outbreak in unvaccinated
populations.
Moreover, even though the U.S. is approaching the time where there
is sufficient vaccine supply for the entire U.S. population,
administering the vaccine throughout the country will still take more
time. As of May 24, 2021, CDC statistics show that 43% of the
population between 18 and 65 has been fully vaccinated (CDC, May 24,
2021a). To this end, there is still a need to strengthen confidence in
the safety and effectiveness of the vaccines for significant portions
of the population, including workers, to reduce vaccine hesitancy. Even
in the healthcare industry, where distribution has enabled entire
worker populations to be completely vaccinated by now, some workers
exhibited reluctance to getting vaccinated. On January 4, 2021, a study
of 1,398 U.S. emergency department health care personnel found that 95%
were offered the vaccine, with 14% declining (Schrading et al.,
February 19, 2021). In February of 2021, the CDC released a study of
initial vaccine efforts at skilled nursing facilities offering long-
term care (Gharpure et al., February 5, 2021). The study found that
only 37.5% of eligible staff were vaccinated, leaving a potentially
significant population vulnerable to SARS-CoV-2 infections and capable
of transmission.
An anonymous survey of employees across the Yale Medicine and Yale
New Haven Health system was used to estimate the prevalence of and
underlying reasons for COVID-19 vaccine hesitancy. The survey was sent
to about 33,000 employees and medical staff across the Yale healthcare
system and included clinical staff and those who support the critical
infrastructure without direct patient contact (e.g., food service
staff). Out of 3,523 responses (an 11% response rate), 85% of
respondents stated they were ``extremely likely'' or ``somewhat
likely'' to receive the COVID-19 vaccine. Of that 85%, 12% expressed
mild hesitancy by stating they would get it within the next 6 months.
But 14.7% of overall respondents expressed reluctance by responding
``neither likely nor unlikely,'' ``somewhat unlikely,'' or ``extremely
unlikely'' to receive the COVID-19 vaccine. Overall, 1 in 6 personnel
in this health system survey expressed at least
some reluctance to get vaccinated (Roy et al., December 29, 2020).
Findings in more recent surveys of the general working population
from 18 to 65 years old show similar rates of people who stated they
would not, probably would not, or would only if required get vaccinated
(18.2%) (Census Bureau, May 5, 2021); 17-26% (KFF, April 22, 2021). In
March 2021, a survey found that healthcare employees reported some of
the highest vaccination percentages of any sector (78.3% and 67.7%,
respectively; King et al., April 24, 2021). However, future growth of
vaccination may be a concern with vaccine hesitation in those sectors
reported as 14.1% and 15.9%, respectively.
That unvaccinated healthcare workers remain in grave danger is
emphasized by the fact that thousands of new hospital admissions still
occur each day (CDC, May 24, 2021b) in the midst of significant
distribution of over three hundred million effective vaccine doses.
These factors indicate that transmission remains robust and significant
portions of the population remain vulnerable to COVID-19. Spread of the
disease within the healthcare workforce may start with a worker
becoming ill through community transmission or an ill patient seeking
treatment. The rate of new cases, hospitalizations, and deaths peaked
in January 2021, just before vaccines became more widely available
outside of healthcare settings. The January to February decline,
however, is likely not attributable in large part to the new vaccines
alone, because only a small portion of the population had received
them. During this time, variants of concern, such as B.1.1.7, that are
more transmissible and may result in worse health outcomes, have become
the majority source of infection (CDC, May 24, 2021c). Hundreds of
people each day are still dying of COVID-19 in early May 2021, many of
them working-age adults (May 24, 2021d).
OSHA will continue to monitor trends as more of the population
becomes vaccinated and the post-vaccine evidence base continues to
grow. If and when OSHA finds a grave danger from the virus no longer
exists for covered healthcare workplaces (or some portion thereof), or
new information necessitates a change in measures necessary to address
the grave danger, OSHA will update the rule as appropriate.
In summary, the availability and use of safe and effective vaccines
for COVID-19 is a critical milestone that has led to a marked decrease
in risk for healthcare employees generally, but grave danger still
remains for those whose jobs require them to work in settings where
patients with suspected or confirmed COVID-19 receive care. CDC has
determined that the remaining risk for fully vaccinated persons outside
of healthcare settings is low enough to justify foregoing other layers
of controls for settings where all persons are fully vaccinated and
asymptomatic (CDC, April 27, 2021), but the CDC continues to recommend
respirators and PPE for fully vaccinated healthcare employees in
settings where patients with suspected or confirmed COVID-19 receive
care. Based on CDC guidance and the best available evidence, OSHA finds
a grave danger in healthcare for vaccinated and unvaccinated HCP
involved in the treatment of COVID-19 patients.
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King, WC et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
Levine-Tiefenbrun, M et al., (2021, February 8). Decreased SARS-CoV-2 viral load following vaccination. medRxiv. 2021; https://www.medrxiv.org/content/10.1101/2021.02.06.21251283v1.full.pdf.
(Levine-Tiefenbrun, February 8, 2021).
Marks, M et al., (2021, February 2). Transmission of COVID-19 in 282
clusters in Catalonia, Spain: A cohort study. Lancet Infect Dis.
21(5): 629-636. doi: 10.1016/S1473-3099(20)30985-3. Epub 2021 Feb 2.
PMID: 33545090; PMCID: PMC7906723. (Marks et al., February 2, 2021).
Pawlowski, C et al., (2021, February 27). FDA-authorized COVID-19
vaccines are effective per real-world evidence synthesized across a
multi-state health system. medRxiv [Preprint posted online February
27, 2021]. https://www.medrxiv.org/content/10.1101/2021.02.15.21251623v3. (Pawlowski et al., February 27, 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. https://catalyst.nejm.org/doi/full/10.1056/CAT.20.0676. (Roy et al., December 29, 2020).
Schrading, WA et al., (2021, February 19). Vaccination rates and
acceptance of SARS-CoV-2 vaccination among U.S. emergency department
health care personnel. Acad Emerg Med 28: 455-458. (Schrading et
al., February 19, 2021).
Shah, ASV et al., (2021, March 21). Effect of vaccination on
transmission of COVID-19: an observational study in healthcare
workers and their households. medRxiv. 2021 https://www.medrxiv.org/content/10.1101/2021.03.11.21253275v1. (Shah et al., March 21,
2021).
Swift, MD et al., (2021, April 26). Effectiveness of mRNA COVID-19
vaccines against SARS-CoV-2 infection in a cohort of healthcare
personnel. Clinical Infectious Diseases DOI: https://doi.org/10.1093/cid/ciab361. (Swift et al., April 26, 2021).
Tande, AJ et al., (2021, March 10). Impact of the COVID-19 Vaccine
on asymptomatic infection among patients undergoing pre-procedural
COVID-19 molecular screening. Clin Infect Dis. 2021 Mar 10: ciab229.
doi: 10.1093/cid/ciab229. Epub ahead of print. PMID: 33704435;
PMCID: PMC7989519. (Tande et al., March 10, 2021).
Teran, RA et al., (2021, April 30). Postvaccination SARS-CoV-2
infections among skilled nursing facility residents and staff
members--Chicago, Illinois, December 2020-March 2021. MMWR 70(17):
632-638. (Teran et al., April 30, 2021).
Thompson, MG et al., (2021, April 2). Interim estimates of vaccine
effectiveness of BNT162b2 and mRNA-1273 COVID-19 vaccines in
preventing SARS-CoV-2 infection among health care personnel, first
responders, and other essential and frontline workers--eight U.S.
locations, December 2020-March 2021. MMWR 70: 495-500. DOI: http://dx.doi.org/10.15585/mmwr.mm7013e3. (Thompson et al., April 2, 2021).
Xie, X et al., (2021, February 8). Neutralization of SARS-CoV-2
spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine
elicited sera. Nature Medicine. DOI: https://doi.org/10.1038/s41591-021-01270-4. (Xie et al., February 8, 2021).
III. Impact on Healthcare Employees
Data on SARS-CoV-2 infections, illnesses, and deaths among
healthcare employees supports OSHA's finding that COVID-19 poses a
grave danger to these employees. Even fairly brief exposure (i.e., 15
minutes during a 24-hour period) can lead to infection, which in turn
can cause death or serious impairment of health. Employees in
healthcare settings include healthcare employees, who provide direct
patient care (e.g., nurses, doctors, and emergency medical technicians
(EMTs)), and healthcare support employees, who provide services that
support the healthcare industry and may have contact with patients
(e.g., janitorial/housekeeping, laundry, and food service employees).
Employees who perform autopsies are also considered to work in
healthcare. Most employees who work in healthcare perform duties that
put them at elevated risk of exposure to SARS-CoV-2.
SARS-CoV-2 is introduced into healthcare settings by infected
patients, other members of the public, or employees. Workers in
healthcare settings that provide treatment to patients with suspected
or confirmed COVID-19 face a particularly elevated risk of contracting
SARS-CoV-2 (Howard, May 22, 2021). Once the virus is introduced into
the worksite, the virus can be transmitted from person-to-person at
close contact through inhalation of respiratory droplets. In limited
scenarios, it might also be transmitted through inhalation of aerosols,
which consists of small droplets and particles that can linger in the
air, especially in enclosed spaces with inadequate ventilation (CDC,
May 7, 2021). Less frequently, transmission is also possible when
someone touches a contaminated item or surface and then touches their
nose, mouth, or eyes (CDC, April 5, 2021).
A 2021 cross-sectional study of 6,510 healthcare employees from the
Northwestern HCW SARS-CoV-2 Serology Cohort Study (conducted May 28-
June 30, 2020 in Illinois) shows that infections among healthcare
workers were not limited to doctors and nurses; healthcare
administrators had similar rates of seropositivity compared to
physicians, and support services had the highest seroprevalence (this
group included healthcare facility workers in
food service, environmental services, security, and patient access/
registration) (Wilkins et al., 2021). A meta-analysis published in the
American Journal of Epidemiologists compared data from 97 separate
studies and found evidence that COVID-19 infections were both common
(11% of the tested cohort of healthcare employees) and spread among
different healthcare worker occupations. In this study, however, nurses
had the highest rate of seroprevalence while most of the COVID-19-
positive medical personnel were working in hospital nonemergency wards
during screening (Gomez-Ochoa et al., January 2021).
Healthcare employees who provide direct patient care are at high
risk of exposure to SARS-CoV-2 because they have close and sometimes
prolonged contact with patients who are infected or potentially
infected with SARS-CoV-2. This contact occurs when conducting physical
examinations and providing treatment and medical support. The risk can
be amplified when examining or treating a COVID-19 patient who has
symptoms such as coughing and difficulty breathing (leading to more
forceful inhalation and exhalation), both of which can result in the
release of more droplets that can be propelled further. Healthcare
employees who conduct, or provide support during, aerosol-generating
procedures on persons with suspected or confirmed COVID-19 also face a
greater risk of infection (Heinzerling et al., April 17, 2020).
Examples of procedures that can produce aerosols include intubation,
suctioning airways, use of high-speed tools during dental work, and use
of power saws during autopsies. A complete list of aerosol-generating
procedures, as defined by this ETS, is included in 29 CFR 1910.502(b).
Employees in healthcare are also at risk of exposure to SARS-CoV-2 if
they have close contact with co-workers while providing patient care or
performing other duties in enclosed areas such as a nursing station,
laundry room, or kitchen. Based on the biological mechanisms of SARS-
CoV-2 transmission, there is no doubt that some employees in healthcare
are at risk of exposure to SARS-CoV-2. Healthcare employees are
performing some job tasks that create an expectation of exposure to
people or human remains infected with COVID-19. The nature of caring
for a patient known to have COVID-19 or performing on autopsy on
someone who had COVID-19 increases the risk to employees performing
that task.
This section summarizes recent studies about U.S. employees in
healthcare that illustrate the impact of COVID-19 in several types of
settings. Because the pandemic is recent and the evidence generated is
on the frontiers of science, studies are not available for every type
of employee in every type of healthcare setting. The peer-reviewed
scientific journal articles, government reports, and journal pre-print
articles described below establish the widespread prevalence of COVID-
19 among healthcare employees. 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). This is critical in the context of the COVID-19
pandemic, where new information is emerging daily. Therefore, OSHA has
supplemented peer-reviewed data and government reports with additional
information on occupational outbreaks contained in other sources of
media (e.g., newspapers). The reported information from newspapers can
provide further evidence of the impact of an emerging and changing
disease, especially for certain workers in healthcare and associated
occupations (e.g., laundry workers, janitors) that are not well
represented in the peer-reviewed scientific literature, and assist OSHA
in protecting these employees from the grave danger posed by
transmission of SARS-CoV-2. OSHA did not make findings based solely on
non-peer-reviewed sources such as pre-prints and news articles, but the
agency found that those sources sometimes provided useful information
when considered in context with more robust sources. Together, these
sources of information represent the best available evidence of the
impact on employees of the pandemic thus far.
The peer-reviewed literature, government reports and, in a limited
number of cases, non-peer-reviewed articles illustrate a significant
number of infections among healthcare employees, but the types of
workplaces or conditions described are not the only ones in which a
grave danger exists. However, the studies add to the evidence that any
healthcare employee is at risk of exposure if they have close contact
with others who are suspected or confirmed to have COVID-19. The
studies also provide evidence that once SARS-CoV-2 is introduced into
the healthcare workplace (e.g., through an infected patient, other
member of the public, or employee), unvaccinated employees in that
workplace are at risk of exposure.
a. General Investigations of Workers or Workplaces
The Washington State Department of Health and the Washington State
Department of Labor and Industries collaborated on a report evaluating
COVID-19 cases and their occupational history (WSDH and WLNI, November
10, 2020). They identified 30,895 confirmed cases of COVID-19 in
Washington State with occupational data, including healthcare settings,
through September 13, 2020. They reported infection rates for 22
occupational groups, and reported that healthcare and social assistance
were among the industry sectors with the highest incidence of
infections (WSDH and WLNI, November 10, 2020). The report states that
some occupations increase the risk to workers of exposure to SARS-CoV-
2, but the data does not demonstrate that all the cases reported
resulted from occupational exposure.
These data were also used to determine how work activities were
related to COVID-19. Zhang used information from a previous Washington
State report with an earlier cutoff date (through June 11, 2020; 10,850
cases) and cross-referenced it with information available from O*NET (a
Department of Labor database that contains detailed occupational
information for more than 900 occupations across the U.S.) to determine
occupation-specific COVID-19 risks (Zhang, November 18, 2020). Zhang
created a model using the O*NET descriptors and correlated it to the
case reports from Washington State to develop a predictive model for
COVID-19 cases. The model found that among O*NET's 57 physical and
social factors related to work, the two predictive variables of COVID-
19 risk were frequency of exposure to diseases and physical proximity
to other people. The author found that healthcare professions in
general had the highest predicted risk for COVID-19. This finding
provides additional evidence that during an active pandemic, healthcare
employees can be exposed to a grave danger during sustained periods in
workspaces where they are working in proximity to others, including
patients with COVID-19.
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 unless their
investigation uncovers an alternative source for the outbreak. In their
May 19, 2021, COVID-19 Weekly Report, OHA reported 71 active clusters,
including at three separate hospitals (OHA, May 19, 2021).
In a May 21, 2021 report, the Tennessee Department of Health
reported 238 active clusters (i.e., 2 or more confirmed cases of COVID-
19 linked by the same location of exposure or exposure event that is
not considered a household exposure), with 6 occurring in assisted care
facilities, 37 in nursing homes, and 3 in other healthcare settings
(Tennessee Department of Health, May 21, 2021).
A study on SARS-CoV-2 testing in Los Angeles from mid-September
through October 2020 evaluated 149,957 symptomatic and asymptomatic
positive cases associated with an occupation (Allan-Blitz et al.,
December 11, 2020). Infection rates were found to be particularly high
for healthcare personnel and first responders.
A Morbidity and Mortality Weekly Report (MMWRs) (a weekly
epidemiological digest published by the CDC) reported on the
occupational status of COVID-19 cases in Colorado. In the Colorado
study, 1,738 COVID-19 cases from nine Colorado counties were evaluated;
these cases occurred before the state lockdown that began on March 26,
2020 (Marshall et al., June 30, 2020). Half of the individuals were
exposed in a workplace setting, with the greatest number of COVID-19-
positive employees coming from healthcare (38%).
Chen et al., (January 22, 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 (March through October 2020) compared to
pre-pandemic periods. Relative to pre-pandemic periods, healthcare or
emergency workers were one occupational group that experienced excess
and statistically significant mortality compared to pre-pandemic
periods (19% increase). The study authors concluded 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 healthcare support, personal care services,
and social services had particularly high mortality rates. The study
authors noted that occupation 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.
The impact of COVID-19 across diverse healthcare sectors is not
limited to the United States. The European Centre for Disease
Prevention and Control investigated clusters in occupational settings
throughout Europe (ECDC, August 11, 2020). The Centre reviewed 1,376
occupational clusters from 16 European countries from March through
July of 2020. Indoor settings contributed to 95% of reported clusters.
Hospitals and long-term care facilities accounted for many of the
clusters.
References
Allan-Blitz, L et al., (2020, December 11). High frequency and
prevalence of community-based asymptomatic SARS-CoV-2 Infection.
medRxix. https://doi.org/10.1101/2020.12.09.20246249. (Allan-Blitz
et al., December 11, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 5).
Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for
Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html. (CDC,
April 5, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Chan, E et al., (2010, December 14). Global capacity for emerging
infectious disease detection. Proceedings of the National Academy of
Sciences of the United States of America, 107(50), 21701-21706.
https://doi.org/10.1073/pnas.1006219107. (Chan et al, December 14,
2010).
Chen, Y et al., (2021, January 22). Excess mortality associated with
the COVID-19 pandemic among Californians 18-65 years of age, by
occupational sector and occupation: March through October 2020.
MedRxiv. doi: 10.1101/2021.01.21.21250266. (Chen et al., January 22,
2021).
European Centre for Disease Prevention and Control (ECDC). (2020,
August 11). COVID-19 clusters and outbreaks in occupational settings
in the EU/EEA and the UK. (ECDC, August 11, 2020).
G[oacute]mez-Ochoa, SA et al., (2021, January). COVID-19 in health-
care workers: a living systematic review and meta-analysis of
prevalence, risk factors, clinical characteristics, and outcomes.
American journal of epidemiology. 2021 Jan; 190(1): 161-75. (Gomez-
Ochoa et al., January 2021).
Hawkins, D et al., (2020, December 21). COVID-19 deaths by
occupation, Massachusetts, March 1-July 31, 2020. American Journal
of Industrial Medicine 64(4): 238-244. DOI: 10.1002/ajim.23227.
(Hawkins et al., December 21, 2021).
Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to
Health Care Personnel During Exposures to a Hospitalized Patient--
Solano County, California, February 2020. MMWR Morb Mortal Wkly Rep
2020; 69: 472-476. DOI: http://dx.doi.org/10.15585/mmwr.mm6915e5.
(Heinzerling et al., April 17, 2020).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
Marshall, K et al., (2020, June 30). Exposure before issuance of
stay-at-home orders among persons with laboratory-confirmed COVID-
19--Colorado, March 2020. MMWR: 69(26): 847-9. (Marshall et al.,
June 30, 2020).
Oregon Health Authority (OHA). (2021, May 19). COVID-19 weekly
outbreak report. https://www.oregon.gov/oha/covid19/Documents/DataReports/COVID-19-Weekly-Outbreak-Report-2021-1-13-FINAL.pdf.
(OHA, May 19, 2021).
Tennessee Department of Health. (2021, May 21). COVID-19 critical
indicators. (Tennessee Department of Health. May 21, 2021).
Washington State Department of Health (WSDH) and Washington State
Department of Labor and Industries (WLNI). (2020, November 10).
COVID-19 confirmed cases by industry sector. Publication Number 421-
002. https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/IndustrySectorReport.pdf. (WSDH and WLNI, November 10, 2020).
Wilkins, JT et al., (2021). Seroprevalence and correlates of SARS-
CoV-2 antibodies in health care workers in Chicago. Open Forum
Infectious Diseases. 8(1): ofaa582. https://doi.org/10.1093/ofid/ofaa582. (Wilkins et al., 2021).
Zhang, M. (2020, November 18). Estimation of differential
occupational risk of COVID-19 by comparing risk factors with case
data by occupational group. American Journal of Industrial Medicine
64(1):39-47. doi: 10.1002/ajim.23199. (Zhang, November 18, 2020).
b. Studies Focusing on Employees in Healthcare
General Surveillance and Surveys Across the U.S.
Burrer et al., (2020) reported surveillance data on COVID-19 cases
and deaths among ``healthcare personnel'' between February 12 and April
9, 2020. ``Healthcare personnel'' were defined as ``paid and unpaid
persons serving in healthcare settings who have the potential for
direct or indirect exposure to patients or
infectious materials.'' \9\ Although only 16% of all surveillance forms
indicated whether the case was healthcare personnel, 19% of the
reported cases occurred in healthcare personnel. Twelve states
indicated whether the case was healthcare personnel for at least 80% of
all reported cases. An estimated 11% of COVID-19 cases from those 12
states were healthcare personnel. Based on reported known contact with
confirmed COVID-19 cases in the 14 days before illness onset, work
exposures likely caused 55% of those infections. Between 8% and 10% of
infected employees were hospitalized, 2%-5% of the infected employees
were admitted to the ICU, and 0.3%-0.6% of those employees died.
---------------------------------------------------------------------------
\9\ The term ``healthcare personnel'' is consistent with OSHA's
use of the terms ``healthcare employees'' and ``healthcare workers''
to include healthcare support workers.
---------------------------------------------------------------------------
CDC continues to provide general updates for COVID-19 cases and
deaths among healthcare personnel. However, information on healthcare
personnel status was reported for only 18.21% of total cases and death
status reported for only 79.57% of healthcare personnel cases as of May
24, 2021 (CDC, May 24, 2021a). CDC reports 491,816 healthcare personnel
cases (10% of the 4,856,885 cases that included information on
healthcare personnel status) and 1,611 fatalities (0.4% of healthcare
employee cases) as of May 24, 2021 (CDC, May 24, 2021a). Independent
reporting by Kaiser Health News and the Guardian in their ongoing
investigative reporting database found 3,607 fatalities among
healthcare personnel in the United States as of April 2021(Kaiser
Health News and the Guardian, April 2021; February 23, 2021). The
reporters for this effort consider even their own count--which is
higher than the official CDC count--to be an undercount due to various
reporting issues, such as a lack of reporting requirements for long-
term care employees for a significant portion of the initial COVID-19
surge.
Hartmann et al., (2020) analyzed case interview data from February
through May 2020 to assess the burden of COVID-19 on healthcare
employees in Los Angeles County, CA, where it is mandated that all
positive cases be reported to the County Department of Public Health,
and all cases are interviewed. Healthcare employees were defined as any
person working or volunteering in healthcare settings including
hospitals and skilled nursing facilities, medical offices, mental
health facilities, and emergency medical services (EMS). The definition
also includes healthcare employees providing care in non-healthcare
settings such as schools, senior living facilities, and correctional
facilities. Healthcare employees included both staff who interacted
directly with patients and staff who do not provide direct clinical
care to patients. Through May 31, 2020, 5,458 COVID-19 cases among
healthcare employees were reported to the County Health Department,
representing 9.6% of all cases during this time period. Of those
healthcare employees, 46.6% worked in a long-term care setting, 27.7%
worked in a hospital, and 6.9% worked in medical offices. Healthcare
employees from all other settings represented less than 4% of total
healthcare employee cases. Nurses represented 49.4% of all healthcare
employee cases; no other group of healthcare employees represented more
than 6% of the total reported healthcare employee cases. Of note is
that some healthcare associated employees who are expected to have less
close contact with patients represented a greater percentage of cases
than some healthcare employee that are expected to have close and
direct patient contact. For example, employees in administration
(4.3%), environmental services (3.2%), and food services (2.9%)
represented a higher percentage of infected healthcare employees than
physicians (2.7%). When asked about known exposures, 44% of those who
tested positive reported exposure to a COVID-19-positive patient or co-
worker in their health facility, 11% reported exposure to a COVID-19-
positive friend or family member or recent travel, and 45.1% had
unknown exposures. At the time of the interviews, 5.3% of COVID-19-
positive healthcare employees in Los Angeles County reported requiring
hospitalization because of COVID-19, and as of May 31, 2020 there were
40 (0.7%) deaths.
Fell et al., (October 30, 2020) reviewed exposure and infection
data for healthcare personnel in Minnesota between March and July of
2020. After the first confirmed case of COVID-19 in Minnesota (on March
6, 2020), the Minnesota Department of Health (MDH) requested that
healthcare facilities provide a list of exposed healthcare personnel.
Healthcare personnel included EMS personnel, nurses/nursing assistants,
physicians, technicians, therapists, phlebotomists, pharmacists,
students and trainees, contractors, and those who do not provide direct
patient care but could be exposed to infectious agents in a healthcare
setting (e.g., clerical, food services, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel). Cases in laboratory
personnel are also reported. The facilities were asked to determine if
each exposure was high-risk, defined as when the healthcare personnel
has close, prolonged contact with a confirmed COVID-19 case or their
secretions/excretions while not wearing PPE, or close, prolonged
contact with persons with COVID-19 in their household or community. MDH
and the 1,217 participating healthcare facilities assessed 17,200
healthcare personnel for 21,406 exposures to COVID-19 cases, of which
5,374 (25%) were classified as higher-risk. It was reported that 373 of
5,374 personnel (6.9%) with high-risk exposures tested positive for
COVID-19 within 14 days of the exposure. The report stated that only
symptomatic personnel were encouraged to get tested for COVID-19, and
therefore it is possible that asymptomatic cases occurred and were not
detected. Of those 373 personnel who tested positive for COVID-19, 242
were exposed to a patient, resident of a congregate setting, in a
congregate setting outbreak, or to another healthcare personnel.
Twenty-one percent of exposures to a confirmed COVID-19 case took place
in acute or ambulatory care settings, 24% of exposures were to
residents in congregate living or long-term care settings, and 25% of
exposures were in congregate setting outbreaks. An additional 25% of
exposures to confirmed COVID-19 cases were exposures to co-workers, and
5% were exposures to household/social contacts.
The Fell study (October 30, 2020) also demonstrated that high risk
exposures can occur to healthcare employees in positions throughout the
healthcare facility. Available data for 4,669 (87%) of the higher risk
exposures in the Fell et al., study indicated that the highest
percentages of high-risk exposures were in nursing assistants or
patient care aides (1,857; 40%) and nursing staff (1,416; 30%). The
proportion of high-risk exposures represented by personnel such as
administrators (247; 5%) and environmental services staff (155; 3%)
were similar to those reported by medical providers, such as physicians
or nurse practitioners (220; 5%). Healthcare personnel working in
congregate living or long-term care settings, including skilled
nursing, assisted living, and group home facilities, were more likely
to receive a positive COVID-19 test result within 14 days of a higher-
risk exposure than were healthcare personnel working in acute care
settings. The study authors note the
potential for employee transmission by cautioning that, in contrast to
the recognized risk associated with patient care, healthcare employees
might have failed to recognize the risk associated with interacting
with co-workers in areas such as breakrooms and nursing stations.
Physical distancing and PPE may therefore not have been used as
consistently in those situations.
The authors of a different study concluded that nurses and EMTs
were, respectively, 26% and 33% more likely to contract COVID-19 than
attending physicians. Nurses and EMTs' job duties require more intense,
close contact with patients compared to physicians, as well as higher
frequency and duration of patient contact. Firew et al., (October 21,
2020) conducted a cross-sectional survey of healthcare employees in May
of 2020 across 48 states, the District of Columbia, and U.S.
territories. The 2,040 respondents who completed at least 80% of the
survey were included in the study. Among included participants, 31.1%
were attending physicians, 26.8% were nurses, 13% were EMTs, 8.82% were
resident physicians or fellows, 3.97% were physician assistants, and
16.32% were other healthcare employees. A total of 598 respondents
(29.3%) reported SARS-CoV-2 infections.
In a prospective study of over 2 million community members and
99,795 frontline healthcare workers that was performed in the U.S. and
UK from March through April 2020, healthcare workers were 3.4 times as
likely to self-report a positive COVID-19 test as the general public,
after adjusting for the increased likelihood of healthcare personnel
receiving a COVID-19 test (Nguyen et al., 2020). In the U.S. alone,
healthcare workers were almost two times more likely to report a
positive test after adjusting for greater likelihood of testing.
Detection of SARS-CoV-2 in Healthcare Employees
OSHA reviewed a number of studies that included hospital employees.
Many hospitals provide short-term and/or long-term care for COVID-19
patients who have symptoms that are severe enough to require
hospitalization. Therefore, close contact with COVID-19 patients is
expected in hospital settings, putting hospital employees at risk of
developing COVID-19. Examples of employees who work in hospitals
include healthcare practitioners, who generally have either licensure
or credentialing requirements (e.g., doctors, nurses, pharmacists,
physical therapists, massage therapists) for the purpose of promoting,
maintaining, monitoring, or restoring health. Individuals who provide
healthcare support services also work at hospitals. Examples of
employees who provide healthcare support services and may have close
contact with COVID-19 patients in some circumstances include patient
intake/admission, patient food services, chaplain services, equipment
and facility maintenance, housekeeping services, healthcare laundry
services, and medical waste handling services. As noted above, hospital
employees are at risk from close contact with patients.
Some of the studies reviewed below were done in employees of
healthcare systems that included both hospitals and ambulatory care
centers such as physician offices, medical clinics (including urgent
care and retail-based clinics), outpatient surgical centers, and
outpatient cancer treatment centers. Although this ETS does not cover
non-hospital ambulatory care settings where all non-employees are
screened prior to entry and people with suspected or confirmed COVID-19
are not permitted to enter, it was not possible to separate out results
for hospital versus ambulatory care employees. Also it is not known to
what extent those ambulatory care centers in the studies reviewed by
OSHA performed screening to identify suspected or confirmed COVID-19.
Risk of exposure and transmission of SARS-CoV-2 is expected to be lower
in ambulatory healthcare settings that perform screening to exclude
persons with suspected or confirmed COVID-19. However some types of
ambulatory medical facilities (e.g., family practice; pediatrics
clinic; urgent care) may choose to test patients for COVID-19 or
examine and treat COVID-19 patients on site. Therefore, healthcare
employees and healthcare support employees in some ambulatory care
centers who do not conduct health screening to identify and exclude
suspected or confirmed COVID-19 patients are at risk of infection due
to close contact with patients who could potentially have COVID-19.
Barrett et al., (2020) conducted a prospective cohort study of
healthcare employees and non-healthcare employees with no known
previous SARS-CoV-2 infection who were recruited and tested for SARS-
CoV-2 from March 24 through April 7, 2020 at Rutgers University and two
of its affiliated university hospitals in New Jersey. As of July 2020,
New Jersey was one of the hardest hit areas, with less than 3% of the
U.S. population but 8.5% of all known U.S. cases. Healthcare employees
were defined as individuals who worked at least 20 hours per week in a
hospital, had occupations with regular patient contact, and were
expected to have contact with at least three patients per shift over
the following three months. Occupations included residents, fellows,
attending physicians, dentists, nurse practitioners, physician
assistants, registered nurses, technicians, respiratory therapists, and
physical therapists. Non-healthcare employees included faculty, staff,
trainees, or students working at Rutgers for at least 20 hours a week
and who had no patient contact. The study reported that 7.3% of
healthcare employees (40 of 546) and 0.4% of non-healthcare employees
(1 of 283) tested positive for SARS-CoV-2 infection. Even after the
authors conducted sensitivity analyses to exclude individuals with
symptoms at baseline and those who had exposure to someone with COVID-
19 or COVID-19 symptoms outside of work, differences between infection
rates in healthcare employees and non-healthcare employees continued to
be observed. OSHA finds this suggests that healthcare employees were
more likely than non-healthcare employees to have developed COVID-19
from a workplace exposure during the early months of the pandemic in
the United States. The study authors concluded that the potential for
workplace exposure is further supported by the fact that only 8% of
infected study subjects reported contact with someone having COVID-19
symptoms outside of work. In addition, higher rates of infection were
observed in healthcare employees who worked in the hospital that had
more COVID-19 patients and was located in the community that had higher
rates of SARS-CoV-2 infections. The study authors noted that because
that hospital was overwhelmed, it was not always possible to separate
COVID-19 vs. non-COVID-19 patients, which may have led to additional
exposures among staff. Among healthcare employees, nurses had the
highest rate of observed infections (11.1% tested positive), and
attending physicians had the lowest rate of observed infection (1.8%
positive). Resident and fellow physicians had a 3.1% positivity rate
and other groups of healthcare employees had a 9% positivity rate.
Increased risk of infection was associated with spending greater
proportions of work time in patients' rooms and higher reported
exposures to patients with suspected or diagnosed COVID-19.
Mani et al., (November 15, 2020) reported results from SARS-CoV-2
testing of 3,477 symptomatic employees in the University of Washington
Medical system and its affiliated organizations in Seattle, WA, between
March 12 and April 23, 2020. During that period, 185 (5.3%) employees
tested positive. Prevalence (i.e., proportion) of SARS-CoV-2 in
frontline healthcare employees (those with face-to-face contact with
patients) was 5.2% and prevalence in non-frontline staff was 5.5%. Some
staff who were asymptomatic also underwent screening as part of
outbreak investigations, and 9 of 151 (6%) tested positive. When
findings from symptomatic and asymptomatic staff were combined, SARS-
CoV-2 prevalence was 5.3% in frontline healthcare employees and 5.3%
among all employees. Of the 174 employees who tested positive and were
followed, six (3.2%) reported COVID-related hospitalization, and one
employee was admitted to the ICU. No deaths were reported. The study
authors suspected that community transmission likely played a major
role in infection among healthcare employees early in the local
epidemic and that similar percentages of infections in frontline and
non-frontline healthcare employees support the PPE protocols
implemented for frontline workers at the institution. In addition,
positive cases were likely underestimated due to the focus on testing
symptomatic employees.
Vahidy et al., (2020) studied asymptomatic infection rates among
staff from a medical center consisting of seven hospitals in Texas and
members of the surrounding community in March through April of 2020.
Healthcare jobs with possible exposure to COVID-19 patients were
classified into five categories, with varying levels of patient
exposure: (1) Nursing (e.g., nurses/nurses aids, emergency medical
technicians), (2) clinicians (e.g., physicians, nurse practitioners),
(3) allied healthcare workers (e.g., therapists, social workers), (4)
support staff (e.g., security, housekeeping), and (5) administrative or
research staff (e.g., managers, research assistants). A total of 2,872
asymptomatic individuals, including 2,787 healthcare personnel and 85
community residents, were tested for SARS-CoV-2 infection. Among the
healthcare personnel tested, the prevalence of SARS-CoV-2 infection was
5.4% among the 1,992 patient-facing staff treating COVID-19 patients
and 0.6% among the 625 patient-facing staff not treating COVID-19
patients. No cases were seen among the 170 nonclinical healthcare staff
that did not interact with patients or in the 85 community residents
(Vahidy et al., 2020). The nonclinical healthcare staff worked in
buildings with separate heating, ventilation, and air conditioning
systems, and with lower population density because of remote work when
compared to clinical healthcare staff. In the different healthcare
categories that cared for COVID-19 patients, prevalence of infection
ranged from 3.6% to 6.5%, with no significant differences in the
different categories of healthcare workers. Therefore, the study
indicates that healthcare workers providing both direct and indirect
care to COVID-19 patients are at risk.
Nagler et al., (June 28, 2020), reported the results of SARS-CoV-2
testing in employees from the New York Langone Health system, an
academic medical center encompassing four hospital campuses and over
250 ambulatory sites, with approximately 43,000 employees. Between
March 25 and May 18, 2020, the health system tested employees who were
symptomatic (4,150), were asymptomatic but exposed to COVID-19 (4,362),
and asymptomatic employees who were returning to work after their
services had been suspended during the peak of the epidemic (6,234).
Among symptomatic employees, the COVID-19 positivity rate across the
duration of the study was 33%. Among asymptomatic employees with self-
reported exposure, the COVID-19 positivity rate was 8%. In asymptomatic
employees returning to work, COVID-19 positivity rate was 3%. In all
groups, the positivity rate in the first week of testing was
substantially higher than in the last week of testing, which occurred
more than a month after the first week. The study authors noted a
temporal correlation of COVID-19 case declines in healthcare employees
and the community, despite continued workplace exposure, and suggested
that infections in healthcare employees may reflect importance of
community transmission and efficacy of stringent infection control and
PPE standards that remained largely unchanged since the start of the
pandemic in March 2020. OSHA finds that the study demonstrates the
potential for COVID-19 to be introduced into the workplace from
uncontrolled community spread and that the effective use of infection
control practices and PPE most likely prevented transmission to
healthcare employees.
Misra-Hebert et al., (September 1, 2020) conducted a retrospective
cohort study to obtain data on rates of COVID-19 and risk factors for
severe disease in healthcare employees and non-healthcare employees
(neither category defined) who were tested for SARS-CoV-2, and listed
in a registry at the Cleveland Clinic Health System, between March 8
and June 9, 2020. The data was drawn from healthcare employees from
different segments of the country. Ninety percent of the healthcare
employees and 75% of non-healthcare employees were from Ohio, and the
remainder were from Florida. Although more healthcare employees than
non-healthcare employees reported exposures to COVID-19 (72% vs. 17%),
similar, and not significantly different, proportions of employees
tested positive for COVID-19 in each group: 9% (551/6145) of healthcare
employees and 6.5% (4353/66,764) of non-healthcare employees. OSHA
finds it difficult to draw conclusions regarding this finding because
the nature of the exposure (e.g., whether it was at close contact) was
not explained. In fact, patient-facing healthcare employees (those
having direct contact with patients) were 1.6 times more likely than
non-patient-facing healthcare employees to test positive. The study
authors suggested that the finding represents an increased risk of
infection with work exposure, however they were not able to confirm if
the exposure occurred 14 days prior to testing or if PPE was worn
during the exposure. Positive cases peaked in early-to-mid April for
both healthcare employees and non-healthcare employees (16% and 12%,
respectively, as estimated from figure 2 of the study), and then
decreased concurrently with the implementation of preventive measures,
such as masking and physical distancing, over the course of the study.
Of those who tested positive, 6.9% of healthcare employees and 27.7% of
non-healthcare employees were hospitalized, and 1.8% and 10.8%
respectively, were admitted to the intensive care unit. The study noted
that the lower rates of hospitalization for the healthcare employee
group could be explained on the basis that the healthcare employee
population was younger and had fewer co-morbidities.
Serology Testing in Employees in Hospitals.
Although most of the studies described in this section relied on
polymerase chain reaction (PCR) tests to detect cases of COVID-19, a
number of studies conducted serology testing to determine how many
individuals had been infected by the SARS-CoV-2 virus in the past.
Serology tests determine if antibodies that respond to the SARS-CoV-2
virus are present in samples of blood serum. Seroprevalence is the
percentage of individuals in a population who have antibodies. Terms
such as seropositive or seroconversion are often used to describe
persons who have tested positive for the SARS-CoV-2 antibody. Most of
the serology tests
conducted looked at a type of antibody known as Immunoglobulin G (IgG).
Seroprevalence studies provide a more complete picture of how many
individuals in a population may have been infected because many
individuals who were infected were not tested for current infections
for reasons such as lack of symptoms and lack of available testing.
Indeed, many individuals who were asymptomatic may be unaware that they
were exposed to SARS-CoV-2 or had COVID-19 (CDC, July 6, 2020). The
studies described below were conducted before vaccination began, and it
is therefore unlikely that the studies are detecting antibodies
produced as a result of vaccination.
Venugopal et al., (2020) conducted a cross-sectional study of
healthcare employees across all hospital services (including
physicians, nurses, ancillary services, and ``others'') who worked at a
level one trauma center in the South Bronx, NY between March 1 and May
1, 2020. The period of analysis included the first few weeks of March,
when New York City experienced a surge of infections that resulted in
strained resources and supplies such as PPE. This hospital was so
highly impacted that it was considered ``the epicenter of the
epicenter.'' Participants were tested for IgG antibodies. They were
also tested for SARS-CoV-2. Of the 500 out of 659 healthcare employees
who completed serology testing, 137 (27%) were positive for SARS-CoV-2
IgG antibodies. Seroprevalence was similar across the different types
of healthcare employees (25% to 28%). The study authors indicated that
seroprevalence in healthcare employees was higher than in the
community, and that seroprevalence likely reflected healthcare and
community exposures.
Sims et al., (November 5, 2020) conducted a prospective cohort
serology study at Beaumont Health, which includes eight hospitals
across the Detroit, MI metropolitan area. In April of 2020, during the
peak of the pandemic's first wave, Michigan had the third highest
number of cases in the U.S. and most cases were in the Detroit
metropolitan area. All 43,000 hospital employees were invited to
participate and seroprevalence was analyzed in 20,614 of them between
April 13 and May 28, 2020. A total of 1,818 (8.8%) of participants were
seropositive. However, when separated according to employees working at
home (n=1,868) versus working in their normal manner, employees working
at home were significantly less likely to be seropositive (5.6%) than
those going into work (9.1%). The authors speculated that the
seropositivity level for employees working at home was representative
of the population sheltering at home and only leaving home when
necessary. Participants involved with direct patient care had a higher
seropositive rate (9.5%) than those who were not (7%). Healthcare
employees with frequent patient contact (phlebotomy, respiratory
therapy, and nursing) had a significantly higher seropositive rate
(11%) than those with intermittent patient contact (physicians or
clinical roles such as physical therapists, radiology technicians,
etc.), who on average had a seropositive rate of 7.4%. The study
authors speculated that the differences in these two groups may have
been based on differences in both duration and proximity of exposure to
patients. Another notable observation is that support personnel such as
facilities/security and administrative support employees had
seropositivity rates of approximately 7% to 8%, which were similar to
rates in physicians (values estimated from Figure 2B). Participants
reporting frequent contact with either 1) non-COVID-19 patients, or 2)
physicians or nurses but not patients, had higher rates of
seropositivity (7.6%) than those reporting no significant contact with
patients, physicians, or nurses (but who handled patient samples)
(6.5%).
Moscola et al., (September 1, 2020) reported the prevalence of
SARS-CoV-2 antibodies in healthcare employees from the Northwell Health
System in the greater New York City area. The healthcare employees were
offered free, voluntary testing at each of the system's 52 sites
between April 20 and June 23, 2020. The analysis included 40,329 of the
system's 70,812 employees and found that 5,523 (13.7%) were
seropositive. The prevalence of SARS-CoV-2 antibodies was similar to
that found in randomly-tested adults in New York State at that time
(14%). Analysis of seropositivity by job type reported the highest
levels of seropositivity (20.9%) in service maintenance staff
(including housekeepers, groundskeepers, medical assistants, and 21
others), followed by 13.1% in nurses, 12.6% in administrative and
clerical staff (including non-clinical professionals such as employees
in information technology, human resources, medical records, and
billing); 11.6% in allied health professionals (including clinical
professionals such as physician assistants, physical therapists/
occupational therapists, social workers, mental health professionals,
pharmacists, and laboratory technicians), and 8.7% in physicians.
Seropositivity rates were highest in employees from the emergency
department and non-ICU hospital units (approximately 17% each),
followed by ``other'' non-specified areas (12.1%), and ICUs (9.9%).
Wilkins et al., (2021) conducted a cross-sectional study to examine
seropositivity rates in 6,510 healthcare workers from a Chicago
healthcare system consisting of hospitals, immediate care centers, and
outpatient practices. Blood samples were collected through July 8,
2020. The study authors then compared the seropositivity rate of
different occupational groups of workers, using administrators as the
referent group to reflect exposure consistent with non-healthcare
workers. Overall seropositivity for all study participants was 4.8%.
Before adjusting for demographics and self-reported out-of-hospital
exposure to COVID-19, the study found that a number of healthcare
occupations had a higher crude prevalence rate than the administrator
group, including: 10.4% for support service healthcare workers; 10.1%
for medical assistants; 9.3% for respiratory technicians; 7.6% for
nurses; and 3.8% for administrators. After adjustment for demographics
and self-reported out-of-hospital exposure to COVID-19, the only type
of healthcare workers that continued to be significantly more likely to
be seropositive than administrators were nurses, who were 1.9 times
more likely to be seropositive. The study authors concluded that the
higher work-related risk in nurses likely occurred as a result of
frequent and close contact with patients. The study also compared
seropositivity rates for different occupational tasks and found that
adjusted seropositivity rates were higher for workers participating in
the care of COVID-19 patients when compared with those who did not
report participating in the care of COVID-19 patients. Being exposed to
patients receiving high-flow oxygen therapy and hemodialysis was
significantly associated with 45% and 57% higher odds for seropositive
status, respectively.
Comparison of Healthcare Worker Serology and the Surrounding Community
Although some serology studies suggest that infections are more
correlated to community transmission than job designation (Jacob et
al., March 10, 2021; Carter et al., May 2021), these studies do not
undermine the robust evidence that healthcare employees with potential
workplace exposure to patients with suspected or confirmed COVID-19 are
exposed to an elevated risk of contracting COVID-19 compared
to the general population. Carter et al., (May 2021) found that
healthcare worker infection rates varied from region to region, noting
the importance of community transmission as a factor in infection
rates. In Jacob et al., (March 10, 2021), health care workers' serology
results were compared to residence location, job designation, and other
characteristics to identify risk factors. The study authors found that
community transmission was a significant factor in acquiring
infections, but were not able to tie in any specific job designation
resulting in increases in infection risk. The authors note, however,
that the study did not show that workplace exposures did not increase
risk; rather it showed that the levels of community transmission
observed may be a greater driver of transmission. It should also be
noted that the non-pharmaceutical interventions for each job
classification are different, so a direct comparison of non-clinical
and clinical personnel may result in conclusions with limited
application.
One might expect that a full shift with fully and properly
implemented non-pharmaceutical interventions should result in lower
infection rates. This appeared evident in a study comparing infection
rates between first and second COVID-19 outbreak surges in Norway
(Magnusson et al., January 6, 2021). For instance, during the first
wave from February 26, 2020 to July 17, 2020, nurses were almost three
times more likely to be infected than those in a similar age range (20
to 70 years old). However, during the second wave from July 18, 2020 to
December 18, 2020, infection rates for nurses were largely
indistinguishable from the population at large of a similar age. The
authors suggested that the decrease in the odds ratio was potentially
due to the implementation of appropriate infection control practices
that were previously lacking.
Studies Examining Risks After Known Exposures
Heinzerling et al., (April 17, 2020) examined the development of
COVID-19 in 120 healthcare employees who were unknowingly exposed to a
patient with COVID-19. The patient was later identified as one of the
first U.S. community cases of COVID-19, and Heinzerling et al., (April
17, 2020) concluded that the ``investigation presented a unique
opportunity to analyze exposures associated with SARS-CoV-2
transmission in a healthcare setting without recognized community
exposures.'' Of the 120 healthcare employees who were exposed, 43
developed symptoms within 14 days of exposure and were tested for
COVID-19. Three of those employees (7% of those tested) were positive
for COVID-19. Although those three employees represent 2.5% of the
total exposed, it is possible that more employees might have developed
COVID-19 because asymptomatic employees were not tested. The healthcare
employees who became infected, when compared to those who were not
infected, were more commonly present during two aerosol-generating
procedures (nebulizer treatment (67% vs. 9%) and non-invasive
ventilation (67% vs. 12%); more commonly performed physical
examinations of the patient (100% vs. 24%); and were exposed to the
patient for longer durations of time (median 120 minutes vs. 25
minutes). None of the exposed healthcare employees had been wearing the
complete set of PPE recommended for contact with COVID-19 patients.
Long-Term Care Facilities
Long-term care facilities include nursing homes, skilled nursing
facilities, and assisted living facilities. They provide both medical
and personal care services to people unable to live independently.
Because long-term care facilities are a congregate living situation,
infections such as COVID-19 can spread rapidly between patients or
residents and the healthcare staff who care for them. Therefore,
employees who work at these facilities have an elevated risk of
exposure and infection. Like employees who work at hospitals, employees
who work at long-term care facilities include both healthcare
practitioners, who may have direct and close contact with patients and
residents, as well as healthcare support staff who could also be
exposed to patients and residents. See the section on ``Detection of
SARS-CoV-2 in Healthcare Employees'' above for a description of the
types of employees who may work at these facilities.
McMichael et al., (March 27, 2020) investigated a COVID-19 outbreak
affecting patients, employees, and visitors at a long-term care
facility in King County, Washington in February of 2020. SARS-CoV-2
infections were identified in 129 persons, including 81 residents, 34
of 170 staff (20%), and 14 visitors. None of the employees died, but 2
of the 34 infected employees (5.9%) had symptoms severe enough to
require hospitalization. The median age of the employees was 42.5 years
(range 22-79 years). Job titles reported for the employees that were
infected included physical therapist, occupational therapist assistant,
environmental care worker, nurse, certified nursing assistant, health
information officer, physician, and case manager. The study authors
noted that infection prevention procedures at the facility were
insufficient, and they concluded that introduction of SARS-CoV-2 into
long-term care facilities will result in high attack rates among
residents, staff, and visitors.
Weil et al., (September 1, 2020) reported a cross-sectional study
of skilled nursing facilities in the Seattle area between March 29 and
May 13, 2020. Testing was performed by Public Health of Seattle and
King County (testing of both residents and staff) or the Seattle Flu
Study (testing of only employees). The authors described the period of
the study to be at the peak of the pandemic, but the skilled nursing
facilities were not experiencing outbreaks at the time of the study.
Testing of employees for SARS-CoV-2 was voluntary, and 1,583 employees
at 16 skilled nursing facilities were tested. Eleven of the 16 skilled
nursing facilities had at least one resident or employee who tested
positive. Forty-six (2.9%) employees had positive or inconclusive
testing for SARS-CoV-2. Of 1208 residents tested, 110 (9.1%) were
positive. Study authors noted shortages in PPE.
Yi et al., (September 7, 2020) evaluated surveillance data on
COVID-19 for assisted living facilities in 39 states (representing 44%
of the total long-term care facilities in the U.S.). The states began
reporting data at various periods ranging from February 27 to April 30,
2020. As of October 15, 2020, 6,440 of 28,623 (22%) assisted living
facilities had at least one COVID-19 case among residents or staff
(ranging from 1.3% of assisted living facilities in Iowa to 92.8% of
assisted living facilities in Connecticut). In 22 states, 17,799 cases
of COVID-19 were reported in staff (total number of staff not
specified). In 9 states, 46 of 7,128 (0.6%) employees with COVID-19
died.
Bagchi et al., (2021) reported on the CDC's National Healthcare
Safety Network (NHSN) surveillance of nursing homes, which began on
April 26, 2020. As of May 25, 2020, the Centers for Medicare & Medicaid
Services (CMS) began requiring nursing homes to report COVID-19 cases
in residents and staff. The authors analyzed data in residents, nursing
home staff, and facility personnel that was reported from May 25
through November 22, 2020 in all 50 states, the District of Columbia,
Guam, and Puerto Rico. Staff members and facility personnel were
defined as ``all persons working or volunteering in the facility,
including contractors,
temporary staff members, resident caregivers, and staff members who
might work at multiple facilities.'' The study authors reported that
``case count data were aggregated weekly, and resident-weeks were
calculated as the total number of occupied beds on the day data were
reported.'' Data on number of staff members employed were not
collected, and therefore ``resident weeks'' was used as ``a closest
best estimate of the at-risk denominator for staff members.'' The study
authors indicated that ``cases per 1,000 resident-week were calculated
for residents and staff members using the number of COVID-19 cases
reported in a week over the corresponding 1,000 resident-weeks.''
COVID-19 cases in staff members increased during June and July (10.9
cases per 1,000 resident-weeks reported in the week of July 26);
declined during August and September (6.3 per 1,000 resident-weeks in
the week of September 13); and increased again by late November (21.3
cases per 1,000 resident-weeks in the week of November 22). The study
authors noted that COVID-19 rates among nursing home staff followed
similar trends in nursing home residents and the surrounding
communities, thereby indicating a possible association between COVID-19
rates in nursing homes and nearby communities.
Terebuh et al., (September 20, 2020) investigated COVID-19 clusters
in 45 congregate living facilities in Ohio, from March 7 to May 15,
2020. Most of the facilities investigated were healthcare worksites.
More than half of the clusters occurred at medical facilities (51% at
nursing homes, 11% at assisted living facilities, 7% at treatment
facilities, and 2% at intermediate care facilities). The remaining
clusters occurred at corrections facilities (7%), group homes (20%),
and shelters (2%). Of the combined 598 residents and healthcare
employees who were either confirmed to have COVID-19 or identified as a
probable case based on symptoms and close contact with a confirmed
case, healthcare employees represented 167 (28%) of the confirmed and
37 (6%) of the probable cases of COVID-19. None of the healthcare
employees died. The study authors were able to identify the index case
in 25 of the clusters, and 88% of the index cases were determined to be
healthcare employees.
Studies Focusing on Healthcare Support Services
Healthcare support services employees, such as personnel that
provide food, laundry, or waste-handling services, are at risk of
exposure to patients with SARS-CoV-2 and contracting COVID-19.
Employees who provide healthcare support services usually have less
direct contact with patients, but they can have close contact with
COVID-19 patients or contaminated materials when performing tasks such
as cleaning patient rooms, removing waste or dirty laundry from patient
rooms, delivering food and picking up used food trays and utensils, or
repairing equipment in the patient's room. In addition, healthcare
support employees can have close and prolonged contact with their co-
workers while performing their duties.
One study discussed above (Sims et al., November 5, 2020), shows an
infection rate among healthcare support services employees that is
similar to healthcare employees, such as physicians, who have some
patient contact. As noted, support personnel such as facilities/
security and administrative support employees had seropositivity rates
of approximately 7% to 8%, which were similar to rates in physicians
(values estimated from Figure 2B). Both healthcare support employees
and physicians had seropositivity rates that were higher than the rates
among employees working from home.
Hale and Dayot (2020) examined an outbreak of COVID-19 among food
service employees that occurred in an academic medical center before
masking and physical distancing requirements were implemented. After an
employee in the food and nutrition department tested positive, 280
asymptomatic staff were tested. The entire food and nutrition
department that was actively working was considered exposed because
employees shared a common locker room and break area. Therefore,
testing was not limited to employees who worked near the index case as
part of their duties. Ten staff members in the department (including
the index case) tested positive during the investigation. At least
seven of the cases were thought to result from transmission from the
index case.
Outbreaks for support services have not been well documented and
may be encapsulated with incidents for the entire hospital. Local
newspaper reports have identified potential incidents in laundry
facilities that handle linens contaminated with SARS-CoV-2. In a New
Jersey unionized laundry facility, representatives noted that eight
employees had been infected with SARS-CoV-2 and demanded improvements
in infectious disease control implementation (Davalos, December 21,
2020). In Canada, a Regina hospital laundry plant was connected with an
18-employee outbreak (Martin, August 10, 2020). The cause of the
outbreak was not determined.
Emergency Medical Services (EMS)
A limited number of studies have examined the impact of COVID-19 on
employees who provide EMS (e.g., EMTs, paramedics), who are considered
healthcare personnel under this standard. The studies that address EMS
often address personnel such as EMTs along with other types of
emergency responders such as firefighters, who are not considered
healthcare personnel under this standard. EMTs and similar occupations,
such as paramedics, have close contact with patients who are or could
be infected with SARS-CoV-2 when they provide medical care or transport
those patients. The medical care they provide includes intubation and
cardiopulmonary resuscitation, which could generate aerosols and put
them at particularly high risk when performing those procedures on
someone with confirmed or suspected COVID-19.
Prezant et al., (2020) reviewed paid medical leave data for EMS
providers and firefighters using New York City fire department
electronic medical records from October 1, 2017 through May 31, 2020.
The study authors found that as of May 31, 2020, 1,792 of 4,408 EMS
providers (40.7%) had been on leave for suspected or confirmed COVID-
19. When compared with the medical leave data from before the
pandemic--including months during influenza periods in prior years--the
authors found that medical leave for EMS providers was 6.8% above
baseline in March 2020 and peaked at 19.3% above baseline in April
2020. The authors determined that COVID-19 was responsible for this
increase. The medical leave levels for EMS providers were above those
for firefighters. Among firefighters, the data showed that 34.5% had
been on leave for suspected or confirmed COVID-19 as of May 31, 2020,
and there was a peak in medical leave at 13.0% above baseline in April
2020. A total of 66 (1.2%) firefighters and EMS providers with COVID-19
were hospitalized and 4 died. Despite EMS providers having been given
the same PPE (not further specified) as firefighters, EMS providers had
higher rates of COVID-19. The study authors concluded that higher rates
in EMS providers were attributable to greater exposure to COVID-19
patients while administering medical care.
Weiden et al., (January 25, 2021) investigated risk factors for
SARS-CoV-2 infection and severe disease (hospitalization or death) in
New York City first responders (EMS and
firefighters) from March 1 through May 31, 2020, based on medical
records. The study had a total of 14,290 participants (3,501 EMS
personnel and 10,789 firefighters). From March 1 to May 31, 2020, 9,115
(63.8%) responders had no COVID-19 diagnosis, 5,175 (36.2%) were
confirmed or suspected COVID-19 cases, and 62 (0.4%) were hospitalized.
Three participants died in a hospital, and one died at home.
Researchers found that EMS respondents had more cases of severe COVID-
19 than firefighters (42/3501 [1.2%] vs. 21/10,789 [0.19%]). The SARS-
CoV-2 infection rate among New York City first responders overall was
15 times the New York City rate. EMS personnel had a 4-fold greater
risk of severe disease and 26% increased risk of confirmed COVID-19
cases when compared with firefighters. Both firefighters and EMS
personnel responded to the pandemic-related emergency medical calls and
followed the same PPE protocols. However, EMS personnel had greater
COVID-19 exposure than firefighters due to greater COVID-19-related
call volume and being solely responsible for patient transport,
nebulization of bronchodilators, and intubation.
Tarabichi et al., (October 30, 2020) recruited first responders
(from EMS and fire departments) to participate in a study in the
Cleveland, Ohio area. The authors conducted a first serologic survey
and virus test in the period between April 20 through May 19, 2020 and
a second between May 18 and June 2, 2020. A total of 296 respondents
completed a first visit and 260 completed the second visit. Seventy-one
percent of respondents reported exposure to SARS-CoV-2 and 16 (5.4%)
had positive serological testing. No subject had a positive virus test.
Fifty percent (8/16) of those who tested positive were either
asymptomatic or mildly symptomatic. Based on responses to questions
about suspected contacts (it does not appear that the time period of
exposure was considered), the study author concluded that likely
sources of transmission in participants who tested positive were
patients or co-workers.
In a study examining COVID-19 antibodies in employees from public
service agencies in the New York City area from May through July of
2020, 22.5% of participants were found to have COVID-19 antibodies
(Sami et al., March 2021). The percentages of EMTs and paramedics found
to have antibodies (38.3 and 31.1%) were among the highest levels
observed in all the occupations. The study authors noted that risk of
exposures may be increased for employees who provide emergency medical
services because those services are provided in uncontrolled,
unpredictable environments, where space is limited (e.g., ambulances)
and quick decisions must often be made. Both emergency technicians and
paramedics perform procedures such as airway management that involve a
high risk of exposure. In fact, the proportions of employees who had
antibodies were found to be increased with increasing frequency of
aerosol-generating procedures.
In-Home Healthcare Providers
In-home healthcare workers provide medical or personal care
services, similar to those provided in long-term care facilities,
inside the homes of people unable to live independently. Patients
receiving in-home care could receive services from different types of
healthcare providers (e.g., a nurse administering medical care, a
physical therapist assisting with exercise, a personal care services
provider assisting with daily functions such as bathing). In addition,
a number of workers may provide services to the same patient, while
working in shifts over the course of the day. In-home healthcare
providers have a high risk of infection from working close to patients
and possibly their family members or other caregivers in enclosed
spaces (e.g., performing a physical examination, helping the patient
bathe).
The impact of COVID-19 on in-home healthcare workers is not well
studied. In-home healthcare workers might be included in reports of
COVID-19 cases and deaths in healthcare workers, but those reports do
not indicate if any of the affected healthcare workers provided home
care. One report from the UK indicated that an occupational category of
``social care'' which included ``care workers and home carers''
experienced significantly increased rates of death involving COVID-19
(50.1 deaths per 100,000 men and 19.1 deaths per 100,000 women) from
March through May of 2020 (Windsor-Shellard et al., June 26, 2020). And
in a related study from March through December of 2020, it was reported
that nearly three in four deaths involving COVID-19 in social care
operations were in ``care workers and home carers,'' with 109.9 deaths
per 100,000 men and 47.1 deaths per 100,000 women (Windsor-Shellard et
al., January 25, 2021).
Conclusion
The representative studies OSHA described in this section on
healthcare provide examples of the pervasive impact that SARS-CoV-2
exposures have had on employees in those industries before vaccines
were available. Even since vaccines have become widely available,
approximately 20 to 30% of healthcare workers remained unvaccinated as
of March 2021 (King et al., April 24, 2021), and breakthrough cases
among vaccinated healthcare employees are evident. The evidence is
consistent with OSHA's determination that SARS-CoV-2 poses a grave
danger to healthcare employees. Cases or outbreaks in settings such as
hospitals, long-term care facilities, and emergency services
departments have had a clear impact on employees in those types of
workplaces. The evidence establishes that employees in those settings,
whether they provide direct patient care or supporting services, have
been infected with SARS-CoV-2 and have developed COVID-19. Some of
these employees have died and others have become seriously ill.
Employees in healthcare are at elevated risk for transmission in the
workplace. Employees in these industry settings are exposed to these
forms of transmission through in-person interaction with patients and
co-workers in settings where individuals with suspected or confirmed
COVID-19 receive care. In many cases, close contact with people who are
suspected or confirmed to have COVID-19 is required of personnel in
these types of workplaces, and such close contact usually occurs
indoors. These employees, who form the backbone of the nation's medical
response to the COVID-19 public health emergency, clearly require
protection under this ETS.
References
Bagchi, S et al., (2021). Rates of COVID-19 among residents and
staff members in nursing homes--United States, May 25-November 22,
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(Bagchi et al., 2021).
Barrett, ES et al., (2020). Prevalence of SARS-CoV-2 infection in
previously undiagnosed health care workers in New Jersey, at the
onset of the US COVID-19 pandemic. BMC infectious diseases 20(1): 1-
0. doi: 10.1101/2020.04.20.20072470. (Barrett et al., 2020).
Burrer, SL et al., (2020). Characteristics of health care personnel
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69(15): 477-481. https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e6.htm. (Burrer et al., 2020).
Carter, RE et al., (2021, March 26). Prevalence of SARS-CoV-2
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Centers for Disease Control and Prevention (CDC). (2020, July, 6).
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2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021a).
Davalos, J. (2020, December 21). Hospital laundry workers fear their
infection risk is rising. Bloomberg. https://www.bloomberg.com/news/articles/2020-12-21/hospital-laundry-workers-say-every-day-at-work-risks-covid-infection. (Davalos, December 21, 2020).
Fell, A et al., (2020, October 30). SARS-CoV-2 exposure and
infection among health care personnel--Minnesota, March 6-July 11,
2020. MMWR 69(43): 1605-1610. https://www.cdc.gov/mmwr/volumes/69/wr/mm6943a5.htm?s_cid=mm6943a5_x. (Fell et al., October 30, 2020).
Firew, TS et al., (2020). Protecting the front line: A cross-
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the COVID-19 pandemic in the USA. BMJ Open 10(10). doi: 10.1136/
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Hale, M and Dayot, A. (2020). Outbreak investigation of COVID-19 in
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Hartmann, S et al., (2020). Coronavirus 2019 (COVID-19) Infections
among healthcare workers, Los Angeles County, February-May 2020.
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Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to
health care personnel during exposures to a hospitalized patient--
Solano County, California, February 2020. MMWR 69(15): 472-476.
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Jacob, JT et al., (2021, March 10). Risk Factors Associated With
SARS-CoV-2 Seropositivity Among US Health Care Personnel. JAMA Netw
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(Jacob et al., March 10, 2021).
Kaiser Health News and the Guardian. (2021, February 23). Lost on
the Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the
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Kaiser Health News and the Guardian. (2021, April). Lost on the
Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the
Guardian, April 2021).
King, WC et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
Magnusson, K et al., (2021, January 6). Occupational risk of COVID-
19 in the 1st and 2nd wave of infection. medRxiv https://doi.org/10.1101/2020.10.29.20220426. (Magnussen et al., January 6, 2021).
Mani, NS et al., (2020, November 15). Prevalence of COVID-19
infection and outcomes among symptomatic healthcare workers in
Seattle, Washington. Clin Infectious Disease 71(10): 2702-2707. doi:
10.1093/cid/ciaa761. (Mani et al., November 15, 2020).
Martin, A. (2020, August 10). Outbreak at Regina's K-Bro Linens: 18
employees test positive. Regina Leader-Post. https://leaderpost.com/news/local-news/outbreak-at-reginas-k-bro-linens-18-employees-test-positive. (Martin, August 10, 2020).
McMichael, TM et al., (2020, March 27). Epidemiology of Covid-19 in
a long-term care facility in King County, Washington. New England
Journal of Medicine 382(21): 2005-2011. doi: 10.1056/NEJMoa2005412.
(McMichael et al., March 27, 2020).
Misra-Hebert, AD et al., (2020, September 1). Impact of the COVID-19
pandemic on healthcare workers' risk of infection and outcomes in a
large, integrated health system. Journal of General Internal
Medicine 35: 3293-3301. https://doi.org/10.1007/s11606-020-06171-9.
(Misra-Hebert et al., September 1, 2020).
Moscola, J et al., (2020, September 1). Prevalence of SARS-CoV-2
antibodies in health care personnel in the New York City Area. JAMA
324(9): 893-895. doi: 10.1001/jama.2020.14765. (Moscola et al.,
September 1, 2020).
Nagler, AR et al., (2020, June 28). Early results from SARS-CoV-2
PCR testing of healthcare workers at an academic medical center in
New York City. Clinical Infectious Diseases 72(7): 1241-1243. doi:
10.1093/cid/ciaa867. (Nagler et al., June 28, 2020).
Nguyen, LH et al., (2020). Risk of COVID-19 among front-line health-
care workers and the general community: a prospective cohort study.
The Lancet Public Health 5(9): e475-e483. https://doi.org/10.1016/S2468-2667(20)30164-X. (Nguyen et al., 2020).
Prezant, DJ et al., (2020). Medical leave associated with COVID-19
among emergency medical system responders and firefighters in New
York City. JAMA Netw Open 3(7). https://doi.org/10.1001/jamanetworkopen.2020.16094. (Prezant et al., 2020).
Sami, S et al., (2021, March). Prevalence of SARS-CoV-2 antibodies
in first responders and public safety personnel, New York City, New
York, USA, May-July 2020. Emerging Infectious Diseases 27(3).
https://doi.org/10.3201/eid2703.204340. (Sami et al., March 2021).
Sims, MD et al., (2020). COVID-19 seropositivity and asymptomatic
rates in healthcare workers are associated with job function and
masking. Clinical Infectious Diseases. doi: 10.1093/cid/ciaa1684.
(Sims et al., November 5, 2020).
Tarabichi, Y et al., (2020, October 30). SARS-CoV-2 infection among
serially tested emergency medical services workers. Prehospital
Emergency Care 25(1): 39-45. https://doi.org/10.1080/10903127.2020.1831668. (Tarabichi et al., October 30, 2020).
Terebuh et al., (2020, September 20). Characterization of community-
wide transmission of SARS-CoV-2 in congregate living settings and
local public health-coordinated response during the initial phase of
the COVID-19 pandemic. Influenza Other Respir Viruses. doi: 10.1111/
irv.12819. (Terebuh et al., September 20, 2020).
Vahidy, FS et al., (2020) Prevalence of SARS-CoV-2 infection among
asymptomatic health care workers in the greater Houston, Texas,
area. JAMA Network Open 3(7): e2016451. https://doi.org/10.1001/jamanetworkopen.2020.16451. (Vahidy et al., 2020).
Venugopal, U et al., (2020, January). SARS-CoV-2 seroprevalence
among health care workers in a New York City hospital: A cross-
sectional analysis during the COVID-19 pandemic. International
Journal of Infectious Diseases 102: 63-69. https://doi.org/10.1016/j.ijid.2020.10.036. (Venugopal et al., January 2020).
Weiden, M et al., (2021, January 25). Pre-COVID-19 lung function and
other risk factors for severe COVID-19 in first responders. ERJ open
research 7(1): 00610-2020. https://doi.org/10.1183/23120541.00610-2020. (Weiden et al., January 25, 2021).
Weil, A et al., (2020, September 1). Cross-sectional prevalence of
SARS-CoV-2 among skilled nursing facility employees and residents
across facilities in Seattle. J Gen Intern Med 35: 11. doi: 10.1007/
s11606-020-06165-7. (Weil et al., September 1, 2020).
Wilkins, JT et al., (2021). Seroprevalence and correlates of SARS-
CoV-2 antibodies in health care workers in Chicago. Open Forum
Infectious Diseases 8(1). https://doi.org/10.1093/ofid/ofaa582.
(Wilkins et al., 2021).
Windsor-Shellard, B and Butt, A. (2020, June 26). Coronavirus
(COVID-19) related deaths by occupation, England and Wales: deaths
registered between 9 March and 25 May 2020. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/coronaviruscovid19relateddeathsbyoccupationenglandandwales/deathsregisteredbetween9marchand25may2020.
(Windsor-Shellard and Butt, June 26, 2020).
Windsor-Shellard, B and Nasir, R. (2021, January 25). Coronavirus
(COVID-19) related deaths by occupation, England and Wales: deaths
registered between 9 March and 28 December 2020. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/coronaviruscovid19relateddeathsbyoccupationenglandandwales/deathsregisteredbetween9marchand28december2020. (Windsor-Shellard
and Nasir, January 25, 2021).
Yi, H et al., (2020, September 7). Health equity considerations in
COVID-19: geospatial network analysis of the COVID-19 outbreak in
the migrant population in Singapore. J Travel Med. DOI: 10.1093/jtm/
taaa159. (Yi et al., September 7, 2020).
IV. Conclusion
OSHA finds that healthcare employees face a grave danger from
exposure to SARS-CoV-2 in the United States.\10\ OSHA's determination
is based on three separate manifestations of incurable, permanent, or
non-fleeting health consequences of exposure to the virus, each of
which is independently supported by substantial evidence in the record.
The danger to healthcare employees is further supported by powerful
lines of evidence demonstrating the transmissibility of the virus in
the workplace and the prevalence of infections in employee populations
where individuals with suspected or confirmed COVID-19 receive care.
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\10\ The determination that COVID-19 presents a grave danger to
healthcare employees is not based on a determination that workplace
protections previously adopted by any particular employer to address
the risk of infection are necessarily inadequate. As discussed in
the Feasibility section, many such workplace protections are
consistent with the uniform nationwide requirements set forth in the
ETS. The purpose of the ETS is to ensure sufficient protections for
workers are consistently implemented across the country.
---------------------------------------------------------------------------
First, 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. The risk of death from COVID-19
is especially high for employees who have underlying health conditions,
older employees, and employees who are members of racial and ethnic
minority groups, who together make up a significant proportion of the
working population. Second, even for those who survive a SARS-CoV-2
infection, the virus often causes 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. Third, even mild
or moderate cases of COVID-19 that do not require hospitalization can
be debilitating and require medical care and significant time off from
work for recovery and quarantine. People who initially appear to have
mild cases can suffer health effects that continue months after the
initial infection. Furthermore, racial and ethnic minority groups are
at increased risk of SARS-CoV-2 infection, as well as hospitalization
and death from COVID-19.
Each of these categories of health consequences independently poses
a grave danger to individuals exposed to the virus. That danger is
amplified for healthcare employees because of the high potential for
transmission of the virus in healthcare settings where individuals with
suspected or confirmed COVID-19 receive care. 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 these settings,
which can result in large-scale clusters of infections. Transmission is
most prevalent in healthcare settings where individuals with suspected
or confirmed COVID-19 receive care, and can be exacerbated by, for
example, poor ventilation, close contact with potentially infectious
individuals, and situations where aerosols containing SARS-CoV-2
particles are likely to be generated. Importantly, while older
employees and those with underlying health conditions face a higher
risk of dying from COVID-19 once infected, fatalities are certainly not
limited to that group. Every healthcare workplace exposure or
transmission has the potential to cause severe illness or even death,
particularly in unvaccinated healthcare workers in settings where
patients with suspected or confirmed COVID-19 receive care. Taken
together, the multiple, severe health consequences of COVID-19 and the
evidence of its transmission in environments characteristic of the
healthcare workplaces where this ETS requires worker protections
demonstrate that exposure to SARS-CoV-2 represents a grave danger to
employees in these workplaces throughout the country.\11\
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\11\ Note that OSHA has made no determination regarding the
significance of the risk to employees from exposure to SARS-CoV-2,
as would be required in a permanent rulemaking under section 6(b)(5)
of the OSH Act, 29 U.S.C. 655(b)(5). OSHA has only considered
whether exposure to SARS-CoV-2 poses a grave danger, as required for
promulgation of a permanent standard under section 6(c)(1)(A), 29
U.S.C. 655(c)(1)(A).
---------------------------------------------------------------------------
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. Although OSHA cannot estimate the total number of
healthcare workers in our nation who contracted COVID-19 at work and
became sick or died, COVID-19 has killed 587,342 people in the United
States as of May 24, 2021 (CDC, May 24, 2021a). That death toll
includes 91,351 people who were 18 to 64 years old (CDC, May 24,
2021b). Current mortality data shows that unvaccinated people of
working age have a 1 in 217 chance of dying when they contract COVID-
19. As of May 24, 2021, more than 32 million people in the United
States have been reported to have infections, and thousands of new
cases were being identified daily (CDC, May 24, 2021c). One in ten
reported cases of COVID-19 becomes severe and requires hospitalization.
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,
2021; CDC, May 26, 2021; Escobar et al., 2021; Gross et al., 2020;
McLaren, 2020). Given this context, OSHA is confident in its finding
that exposure to SARS-CoV-2 poses a grave danger to the healthcare
employees covered by the protections in 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 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 a century. The evidence
compiled above amply support OSHA's finding that SARS-CoV-2 presents a
grave danger in to the healthcare employees covered by the protections
in this ETS. 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, 656, 100 S. Ct. 2844, 2871, 65 L. Ed. 2d 1010
(1980). This is true a fortiori here in the current national crisis
where OSHA must act to ensure employees are adequately protected from
the new hazard presented by the COVID-19 pandemic (see 29 U.S.C
655(c)(1)).
Having made the determination of grave danger, as well as the
determination that an ETS is necessary to protect these employees from
exposure to SARS-CoV-2 (see Need for the ETS, in Section IV.B. of this
preamble), OSHA is required to issue this standard to protect these
employees from getting sick and dying from COVID-19 acquired at work.
See 29 U.S.C. 655(c)(1).
References
Centers for Disease Control and Prevention (CDC). (2020, December
10). COVID-19 racial and ethnic health disparities. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/index.html. (CDC, December 10, 2020).
Centers for Disease Control and Prevention (CDC). (2021, May 26).
Health disparities: race and Hispanic origin. https://www.cdc.gov/nchs/nvss/vsrr/covid19/health_disparities.htm. (CDC, May 26, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Deaths by age group. https://covid.cdc.gov/covid-data-tracker/#demographics. (CDC, May 24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.(CDC, May 24, 2021c).
Escobar, GJ et al., (2021, February 9). Racial disparities in COVID-
19 testing and outcomes. Annals of Internal Medicine. doi: 10.7326/
M20-6979. (Escobar et al., February 9, 2021).
Gross, CP et al., (2020, October). Racial and ethnic disparities in
population-level COVID-19 mortality. Journal of General Internal
Medicine 35(10): 3097-3099. doi: 10.1007/s11606-020-06081-w. (Gross
et al., October 2020).
McLaren, J. (2020, June). Racial disparity in COVID-19 deaths:
Seeking economic roots with Census data. NBER Working Paper Series.
Working Paper 27407. doi: 10.3386/w27407. (McLaren, June 2020).
B. Need for the ETS
This ETS is necessary to protect the healthcare workers with the
highest risk of contracting COVID-19 at work. Healthcare workers face a
particularly elevated risk of contracting COVID-19 in settings where
patients with suspected or confirmed COVID-19 receive treatment,
especially those healthcare workers providing direct care to patients.
The ETS is necessary to protect these workers through requirements
including patient screening and management, respirators and 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 anti-retaliation provisions and
medical removal protection.
I. Events Leading to the ETS
Since January 2020, OSHA has 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 healthcare 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; Wellington, March 12, 2020;
DeVito, March 12, 2020; Carome, March 13, 2020; Murray et al., April
29, 2020; Solt, April 28, 2020; Public Citizen, March 13, 2020;
Pellerin, March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020;
ORCHSE, October 9, 2020). These petitions and supporting letters
asserted that many employees have been infected because of workplace
exposures to the virus that causes COVID-19 and immediate, legally
enforceable action is necessary for protection. OSHA quickly began
issuing detailed guidance documents and alerts beginning in March 2020
that helped employers determine employee risk levels of COVID-19
exposure and made recommendations for appropriate controls.
On March 18, 2020, then-OSHA Principal Deputy Assistant Secretary
Loren Sweatt responded to an inquiry from Congressman Robert C.
``Bobby'' Scott, Chairman of the House Committee on Education and
Labor, regarding OSHA's response to the COVID-19 outbreak (OSHA, March
18, 2020). In the letter, she stated that OSHA had ``a number of
existing enforcement tools'' it was using to address COVID-19,
including existing standards such as Personal Protective Equipment
(PPE), Respiratory Protection, and Bloodborne Pathogens, as well as the
General Duty Clause, 29 U.S.C. 654(a)(1). She also stated that OSHA was
working proactively to assist employers by developing guidance
documents. And, given the existing enforcement tools, ``we currently
see no additional benefit from an ETS in the current circumstances
relating to COVID-19,'' and ``OSHA can best meet the needs of America's
workers by being able to rapidly respond in a flexible environment.''
However, she noted that OSHA would continue to monitor ``this quickly
evolving situation and will take appropriate steps to protect workers
from COVID-19 in coordination with the overall U.S. government response
effort.''
Shortly after OSHA's announcement that it did not intend to pursue
an ETS at that time, the American Federation of Labor and Congress of
Industrial Organizations (AFL-CIO), the country's largest federation of
labor unions, filed an emergency petition with the U.S. Court of
Appeals for the D.C. Circuit, for a writ of mandamus to compel OSHA to
issue an ETS for COVID-19, arguing that OSHA's failure to issue legally
enforceable COVID-19-specific rules endangered workers (AFL-CIO, May
18, 2020). On May 29, 2020, OSHA denied the AFL-CIO's pending March 6
petition to OSHA for an ETS \12\ and simultaneously filed a response
brief with the D.C. Circuit, arguing the AFL-CIO was not entitled to a
writ of mandamus (DOL, May 29, 2020). The agency stated that the union
had not clearly and indisputably demonstrated that an ETS was necessary
and expressed its view that an ETS was not necessary at that time
because of the agency's two-pronged strategy for addressing COVID-19 in
the workplace:
Enforcement of existing standards and section 5(a)(1) of the OSH Act
(the General Duty Clause), as well as development of rapid guidance to
provide a flexible response to new and evolving information about the
virus. 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,
finding that OSHA's ``decision not to issue an ETS is entitled to
considerable deference,'' and ``[i]n light of the unprecedented nature
of the COVID-19 pandemic, as well as the regulatory tools that the OSHA
has at its disposal to ensure that employers are maintaining hazard-
free work environments, . . . OSHA reasonably determined that an ETS is
not necessary at this time.'' In re Am. Fed'n of Labor & Cong. of
Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO, June 11, 2020),
rehearing en banc denied (AFL-CIO, July 28, 2020).\13\
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\12\ The AFL-CIO had petitioned OSHA on March 6 to issue an ETS
to protect working people from occupational exposure to infectious
diseases broadly, including COVID-19 (AFL-CIO, March 6, 2020). In
OSHA's May 29, 2020 denial, the agency concluded that it lacked
compelling evidence to find that an undefined category of infectious
diseases generally posed a grave danger for which an ETS was
necessary (OSHA, May 29, 2020). With respect to COVID-19
specifically, the agency made no conclusion as to whether the
disease posed a grave danger to workers, but concluded, as it had in
the earlier March 18, 2020 response to congressional inquiry, that a
COVID-19 ETS was not necessary at that time (id.).
\13\ On October 29, 2020, a group of petitioners including the
American Federation of Teachers (AFT), the American Federation of
State, County and Municipal Employees, the Washington State Nurses
Association, and the United Nurses Association of California/Union
of Health Care Professionals filed a separate petition for a writ of
mandamus from the U.S. Court of Appeals for the Ninth Circuit to
compel OSHA to issue a permanent standard to protect healthcare
workers from the risks of infectious diseases (AFT, October 29,
2020). On December 31, 2020, OSHA filed a response brief asserting
that the petitioners were not entitled to the requested writ of
mandamus (DOL, December 31, 2020). OSHA explained that, while the
agency has been considering the need for an infectious disease
standard for healthcare workers since at least 2009, it has not yet
made a final determination on the necessity of such a standard, and
that the agency's limited resources at this time are best directed
toward responding to the broader COVID-19 crisis. The Ninth Circuit
granted the parties' request to stay the case because OSHA now
intends to prioritize the infectious disease rulemaking.
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Following OSHA's decision in May 2020 not to issue an ETS, some
states and local health departments determined enforceable regulation
was necessary, leading to the adoption of a variety of state and local
executive orders and emergency regulations with specific worker
protection requirements. Virginia, Oregon, California, Michigan, and
Washington have issued their own ETSs, (see Section VII, Additional
Requirements, for a full discussion of OSHA-approved State Plans), and
many additional states and localities have issued other kinds of
requirements, guidelines, and protective ordinances for workers. Other
states and localities have not. 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. As a result, on October 9, 2020, ORCHSE
Strategies, LLC (since acquired by the National Safety Council (NSC))--
a group of more than 100 large (mostly Fortune 500) companies in over
28 industries--petitioned OSHA to issue an ETS, recognizing that OSHA
had provided ``very well prepared and thoughtful'' guidance, but
concluding an ETS is still needed and that the lack of a uniform
response has caused confusion and unnecessary burden on already
struggling workplaces (ORCHSE, October 9, 2020).
Notwithstanding the patchwork efforts at the state and local level,
the country experienced a significant increase in COVID-19 deaths and
infections. When OSHA decided not to promulgate an ETS in May 2020, the
COVID-19 death toll in the United States was reaching 100,000 (CDC, May
28, 2020). Since then, an additional 500,000 Americans have died from
COVID-19 (CDC, May 24, 2021a). Despite a decrease in recent weeks, the
death rate remains high (7-day moving average death rate of 500 on May
23, 2021) (CDC, May 24, 2021b), and thousands of Americans are
hospitalized with COVID-19 every day (CDC, May 24, 2021c).
As of May 23, 2021, the agency had issued 689 citations for COVID-
19-related violations of existing OSHA requirements, primarily of
healthcare facilities including nursing homes. Violations have
included, among other things, failure to properly develop written
respiratory protection programs; failure to provide a medical
evaluation, respirator fit test, training on the proper use of a
respirator, and personal protective equipment; failure to report an
injury, illness, or fatality; failure to record an injury or illness on
OSHA recordkeeping forms; and failure to comply with the General Duty
Clause of the OSH Act. In addition, OSHA issued over 230 Hazard Alert
Letters (HALs), including over 100 HALs to employers in healthcare
settings (e.g., hospitals, ambulatory care, and nursing and residential
care facilities), where it found COVID-19-related hazards during
workplace inspections, but did not believe it had sufficient basis to
cite the employer for violating an existing OSHA standard or the
General Duty Clause.
On January 21, 2021, President Biden issued Executive Order 13999,
entitled ``Protecting Worker Health and Safety'' (86 FR 7211). In it,
he declared that:
Ensuring the health and safety of workers is a national priority
and a moral imperative. Healthcare workers and other essential
workers, many of whom are people of color and immigrants, have put
their lives on the line during the coronavirus disease 2019 (COVID-
19) pandemic. It is the policy of my Administration to protect the
health and safety of workers from COVID-19. The Federal Government
must take swift action to reduce the risk that workers may contract
COVID-19 in the workplace.
He further directed OSHA to take a number of steps to better
protect workers from the COVID-19 hazard, including issuing revised
guidance on workplace safety, launching a national emphasis program to
focus OSHA enforcement efforts on COVID-19, conduct a multilingual
outreach program, and evaluate its COVID-19 enforcement policies (id.).
In addition, the President directed OSHA to ``consider whether any
emergency temporary standards on COVID-19, including with respect to
masks in the workplace, are necessary, and if such standards are
determined to be necessary, issue them by March 15, 2021'' (id.). OSHA
began working on the issue at once, and shortly after Secretary Walsh
took office on March 23, he ordered OSHA to ensure its analysis
addressed the latest information regarding the state of vaccinations
and virus variants (Rolfson and Rozen, April 6, 2021). In accordance
with the executive order and Secretary Walsh's directive, OSHA has
reviewed its May 2020 decision not to issue an ETS. For the reasons
explained below, OSHA does not believe its prior approach--enforcement
of existing standards and the General Duty Clause coupled with the
issuance of nonbinding guidance--has proven over time to be adequate to
``reduce the risk that workers may contract COVID-19'' in healthcare
settings. Given the grave danger presented by the hazard, OSHA now
finds that this standard is necessary to protect the healthcare
employees who face the highest risk of contracting COVID-19 at work.
See Nat'l Cable & Telecomm. Ass'n v. Brand X internet Svcs, 545 U.S.
967, 981 (2005) (noting that an agency must ``consider the wisdom of
its policy on a continuing basis . . . for example, in response to
changed factual circumstances, or a change in administrations'');
Asbestos Info. Ass'n, 727 F.2d at 423 (5th Cir. 1984) (``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.'').
References
American Federation of Labor and Congress of Industrial
Organizations. (2020, March 6). ``To Address the Outbreak of COVID-
19: A Petition for an OSHA Emergency Temporary Standard for
Infectious Disease.'' (AFL-CIO, March 6, 2020).
American Federation of Labor and Congress of Industrial
Organizations. (2020, May 18). Emergency Petition For A Writ Of
Mandamus, and Request For Expedited Briefing And Disposition, No.
19-1158. (AFL-CIO, May 18, 2020).
American Federation of Labor and Congress of Industrial
Organizations, USCA Case #20-1158, Document #1846700. (2020, June
11). (AFL-CIO, June 11, 2020).
American Federation of Labor and Congress of Industrial
Organizations. Denial of Petition for Rehearing En Banc on Behalf Of
American Federation of Labor and Congress of Industrial
Organizations. USCA Case #20-1158, Document #1853761. (2020, July
28). (AFL-CIO, July 28, 2020).
American Federation of Teachers, et al., Petition For A Writ Of
Mandamus, No. 20-73203 (9th Cir., October 29, 2020). (2020, October
29). (AFT, October 29, 2020).
Carome, M. (2020, March 13). ``Letter requesting an immediate OSHA
emergency temporary standard for infectious disease.'' (Carome,
March 13, 2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory Daily Trends in Number of
COVID-19 Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May
24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker. New Admissions of Patients with Confirmed COVID-
19, United States. https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions. (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2020, May 28).
United States Coronavirus (COVID-19) Death Toll Surpasses 100,000.
https://www.cdc.gov/media/releases/2020/s0528-coronavirus-death-toll.html. (CDC, May 28, 2020).
DeVito, J. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect frontline workers.'' (DeVito, March 12, 2020).
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, April 29). ``COVID-19 ETS
Petition.''(Murray et al., April 29, 2020).
National Nurses United (NNU). (2020, March 4). ``National Nurses
United Petitions OSHA for an Emergency Temporary Standard on
Emerging Infectious Diseases in Response to COVID-19.'' (NNU, March
4, 2020).
Occupational Safety and Health Administration (OSHA). (2020, March
18). Letter from Loren Sweatt to Congressman Robert C. ``Bobby''
Scott. (OSHA, March 18, 2020).
Occupational Safety and Health Administration (OSHA). (2020, May
29). Letter from Loren Sweatt to AFL-CIO President Richard Trumka.
(OSHA, May 29, 2020).
Owen, M. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Owen, March 19, 2020) .
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).
Pellerin, C. (2020). ``Grant OSHA emergency standard to protect
frontline workers from COVID-19.'' (Pellerin, March 19, 2020).
Public Citizen. (2020, March 13). ``Support for AFL-CIO's Petition
for an OSHA Emergency Temporary Standard for Infectious Disease to
Address the Epidemic of Novel Coronavirus Disease.'' (Public
Citizen, March 13, 2020).
Rolfson, B, Rozen, C. (2021, April 6). Labor Chief Walsh Puts Hold
on OSHA Virus Rule for More Analysis. Bloomberg Law. https://news.bloomberglaw.com/safety/labor-chief-walsh-puts-hold-on-osha-virus-rule-for-more-analysis. (Rolfson and Rozen, April 6, 2021).
Scott, RC and Adams, AS. (2020, January 30). ``Prioritize OSHA's
Work on Infectious Diseases Standard/Immediate Issue of Temporary
Standard.'' (Scott and Adams, January 30, 2020).
Solt, BE. (2020). ``COVID-19 ETS Petition.'' (Solt, April 28, 2020).
United States Department of Labor (DOL). (2020, May 29). In Re:
American Federation Of Labor And Congress Of Industrial
Organizations. Department Of Labor's Response to the Emergency
Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29,
2020). (DOL, May 29, 2020).
United States Department of Labor (DOL). (2020, December 31).
American Federation of Teachers, et al., Department of Labor's
Opposition to the Petition for a Writ of Mandamus, No. 20-73203 (9th
Cir., December 31, 2020). (DOL, December 31, 2020).
Wellington, M. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect front-line workers''. (Wellington, March 12,
2020).
Yborra, G. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Yborra, March 19, 2020).
II. No Other Agency Action Is Adequate To Protect Employees Against
Grave Danger
For the first time in its 50-year history, OSHA faces a ``new
hazard'' so grave that it has killed almost 600,000 people in the
United States in barely over a year, and infected millions more. COVID-
19 can be spread to employees whenever an infected person exhales.
Those employees, once infected, could end up unable to breathe without
ventilators or suffer from failure of multiple body organs, and are at
risk of death or long-term debilitation. The COVID-19 pandemic has
taken a particularly heavy toll on workers in healthcare providing
frontline care to patients with suspected or confirmed COVID-19,
creating the precise situation that section 6(c)(1) of the OSH Act was
enacted to address. This ETS is necessary to protect these employees
from the grave danger posed by COVID-19.
When OSHA decided not to issue an ETS last spring, the agency had
preliminarily determined that sufficient employee protection against
COVID-19 could be provided through enforcement of existing workplace
standards and the General Duty Clause of the OSH Act, coupled with the
issuance of industry-specific, non-mandatory guidance. However, in
doing so OSHA indicated that its conclusion that an ETS was not
necessary was specific to the information available to the agency at
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))). OSHA's subsequent
experience has shown that a new approach is needed to protect
healthcare workers from the grave danger posed by the COVID-19
pandemic.
At the outset, 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 healthcare workers
from the grave danger posed by COVID-19.
Multiple developments support a change in approach. First, as noted
above, although the rates of death and hospitalization from COVID-19
have decreased in recent weeks as vaccines have become more widely
available, COVID-19 continues to pose a grave danger to healthcare
employees in settings where the risk of exposure to an infected person
is elevated because of the nature of the work performed. In addition,
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). Several new mutations--or
variants--of the virus, preliminarily understood to be more contagious
than the original, are now spreading in this country.
Second, as discussed in more detail in Grave Danger (Section IV.A
of this preamble), while vaccines have been authorized for use for
several months, and the nationwide effort to fully vaccinate all
Americans is ongoing, more work is needed to build confidence among
Americans in the vaccines so that enough people are protected to bring
the virus under control, and to ensure that employees can get
vaccinated without the risk of losing their jobs or losing pay. The
standard is therefore necessary to facilitate vaccination among
healthcare workers by requiring employers to ``provid[e] reasonable
time and paid leave . . . to each employee for vaccination and any side
effects experienced following vaccination'' (paragraph (m)).
The standard also further encourages vaccination by fully exempting
``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 (paragraph
(a)(2)(iv)) and ``home healthcare settings where all employees are
fully vaccinated'' and all non-employees at that location are screened
prior to employee entry so that people with suspected or confirmed
COVID-19 are not present (paragraph (a)(2)(v)). In addition, the
standard encourages vaccination by exempting fully vaccinated employees
from the requirements for facemasks, physical distancing, and barriers
``in well-defined areas where there is no reasonable expectation that
any person with suspected or confirmed COVID-19 will be present''
(paragraph (a)(4)).
Further, OSHA's actual enforcement experience over the past year--
which had only just begun when OSHA announced its previous views on the
need for an ETS--has demonstrated that existing enforcement options do
not adequately protect healthcare employees from the grave danger posed
by COVID-19. As of May 23, 2021, OSHA and its State Plan partners have
received more than 67,000 COVID-related complaints since March of 2020
(OSHA, May 23, 2021). OSHA has received more complaints about
healthcare settings than any other industry.\14\ Although the number of
employee complaints has gone down in recent months since COVID-19
vaccines have become more widely available, OSHA continues to receive
hundreds of employee complaints every month, including many that
concern healthcare settings, asking for investigations of workplaces
where employees do not believe they are being adequately protected from
COVID-19 and indicating that their employers do not follow the guidance
issued by the agency and the CDC.
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\14\ As a result of these complaints, federal OSHA has conducted
2,305 inspections (State Plans have conducted 7,203 inspections) as
of May 23, 2021. On March 12, 2021, OSHA issued a National Emphasis
program to ensure that OSHA continues to devote a high percentage of
its inspection resources to COVID-19, with a target of roughly 1,600
inspections a year. These can be the result of complaints or
programmed inspections targeted at high hazard industries. However,
as described below, the effectiveness of the NEP will be hampered
without the ETS given the inadequacy of OSHA's current enforcement
tools.
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The following narratives are just a few recent examples of the
kinds of complaints OSHA continues to receive from healthcare employees
on a regular basis:
5/21/21 Doctor's office failed to remove employee with
COVID-19 symptoms.
5/21/21 Assisted living facility for the elderly failed to
notify employees that they were exposed to residents with COVID-19.
5/19/21 Doctor's office did not maintain distancing for
employees, did not notify employees of exposure to COVID-19, and did
not remove employees with COVID-19 symptoms from the workplace.
5/19/21 Doctor's office did not ensure that technician
wore gloves during COVID-19 treatment.
5/10/21 Clinic did not follow guidance for patient
screening or removal from the workplace of potentially infected
employee.
5/7/21 Psychiatric facility did not properly clean rooms
of COVID-19 positive patients, did not train employees to properly
remove infectious disease PPE when exiting COVID-19 positive areas to
other areas of the facility, and allows employees who have tested
positive for COVID-19 to continue to work at the workplace.
5/6/21 Hospital failed to promptly remove employee with
COVID-19 from the workplace, notify other employees of their exposure
to the COVID-19, and did not require employees to wear facemasks.
5/3/21 Doctor's office required employees to reuse
isolation gowns to an extent not consistent with CDC guidance.
This ETS addresses numerous issues raised in these complaints,
including physical distancing, PPE, cleaning and disinfection, and
measures to keep contagious co-workers away from the workplace.
Based on its thorough review of OSHA's existing approach to
protecting employees from COVID-19, OSHA finds that existing OSHA
standards, the General Duty Clause, and non-mandatory guidance issued
by OSHA are not adequate to protect healthcare employees from COVID-19.
Similarly, the numerous guidance products published by other entities,
such as CDC, are not sufficiently effective at protecting these
employees because such guidance is not enforceable and there is no
penalty for noncompliance. OSHA has determined that each of these
tools, as well any combination of them, is inadequate to address COVID-
related hazards in the settings covered by this standard, thereby
establishing the need for this ETS.
This inadequacy has also been reflected in the number of states and
localities that have issued their own mandatory standards in
recognition that existing measures (including non-mandatory guidance,
compliance assistance, and enforcement of existing standards) have
failed to adequately protect workers from COVID-19. While these state
and local requirements may have had positive effects where they have
been implemented, they are no replacement for a national standard that
would establish definitively that COVID-19 safety measures are no
longer
voluntary for the workers covered by this standard. Without a national
standard, the patchwork of inconsistent requirements has proven both
ineffective at a national level and burdensome to employers operating
across jurisdictions, increasing compliance costs and potentially
limiting the ability to implement protective measures at scale (See
ORCHSE, October 9, 2020). Congress has charged OSHA with protecting
America's workforce, and an ETS is the only measure capable of
providing adequate protection to the workers covered by this standard
from the grave danger posed by COVID-19.
a. The Current Standards and Regulations Are Inadequate
In updated enforcement guidance issued in March 2021 (OSHA, March
12, 2021), OSHA identified a number of current standards and
regulations that might apply when workers have occupational exposure to
SARS-CoV-2 (Interim Enforcement Response Plan) (OSHA, March 12,
2021).\15\ In addition to the standards listed there, OSHA has also
cited the Hazard communication standard (29 CFR 1910.1200) during
COVID-19 investigations. Accordingly, the complete list of potentially
applicable standards and regulations follows:
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\15\ The Interim Enforcement Response Plan also suggests that
while OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) does
not typically apply to respiratory secretions that may contain SARS-
CoV-2, the provisions of the standard offer a framework that may
help control some sources of the virus, including exposures to body
fluids (e.g., respiratory secretions) not covered by the standard.
While this is true for some of the controls required by that
standard, such as laundering and cleaning, it does not contain
requirements to implement necessary controls to protect employees
against airborne transmission of SARS-CoV-2, such as distancing,
barriers, and ventilation. And in any event, it imposes no
obligations unless blood or other potentially infectious materials
(as defined in the standard) are present.
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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 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 notes that, when such chemicals are used in the
workplace, the employer is required to comply with the hazard
communication standard. The agency has not incorporated hazard
communication requirements in the ETS, but has included related
training and notification requirements. Section 1910.1200 compliance is
only peripherally related to protection against SARS-CoV-2 hazards,
employers are generally aware of those requirements, and the
requirements of Sec. 1910.1200 are enforceable without being repeated
in the ETS.
Through its enforcement efforts to date, OSHA has encountered
significant obstacles demonstrating that existing standards and
regulations are inadequate to address the COVID-19 hazard for
healthcare workers, and has determined that a COVID-19 ETS is necessary
to address these inadequacies. As discussed in further detail below,
OSHA has determined that some of the above-listed standards--including
Sanitation at Sec. 1910.141--are in practice too difficult to apply to
the COVID-19 hazard and have never been cited in COVID enforcement;
other standards--such as Respiratory Protection at Sec. 1910.134 and
general PPE at Sec. 1910.132--are more clearly applicable to the
COVID-19 hazard, but for a variety of reasons have offered little
protection to the vast majority of employees who are not directly
caring for patients with suspected or confirmed COVID-19. Current CDC
guidance does not indicate that respirators are generally needed
outside of direct patient care, but CDC does support the protective
measures the ETS would require for the workers it covers (Howard, May
22, 2021).
Finally, the remaining listed standards and regulations--for
recordkeeping and reporting, accident prevention signs and tags, access
to employee records, and hazard communication--while applicable to the
COVID-19 hazard and important in the overall scheme of workplace
safety, do not require employers to implement specific measures to
protect workers from COVID-19. Further, as addressed in more detail
below, even applicable regulations like the reporting requirements did
not contemplate a hazard like COVID-19, and have proven to be difficult
to apply to it. Thus, for the reasons elaborated in further detail
below, OSHA has determined that its existing standards and regulations
are insufficient to adequately address the grave danger posed by COVID-
19 to healthcare workers.
First, most of the safety measures known to reduce the hazard of
COVID-19 transmission are not explicitly required by existing
standards: none expressly requires measures such as facilitating
vaccination, facemasks, physical distancing, physical barriers,
cleaning and disinfection (when appropriate), improved ventilation to
reduce virus transmission, isolation of sick employees, minimizing
exposures in the highest hazard settings such as aerosol-generating
procedures on patients with suspected or confirmed COVID-19, patient
screening and management, notification to employees potentially exposed
to people with COVID-19, or training on these requirements. For
example, although OSHA's existing Respiratory Protection and PPE
standards require respirators and PPE such as gloves and face shields
in some settings covered by the ETS, they do not require all of the
other layers of protection required by the ETS that are necessary to
mitigate the spread of COVID-19 in the workplace. See Need for Specific
Provisions (Section V of the preamble).
Similarly, while the Sanitation standard at Sec. 1910.141(a)(3)
requires places of employment ``to be kept clean to the extent that the
nature of the work allows,'' the standard does not require disinfection
of potentially contaminated surfaces nor does it speak to the level or
frequency with which cleaning is required to protect against an
infectious
disease hazard like COVID-19. Accordingly, OSHA has not yet identified
any instance in which the Sanitation standard could be applied in the
agency's COVID-19 enforcement efforts. Thus, OSHA's efforts to enforce
existing standards to address the COVID-19 hazard have been
significantly hindered by the absence of any specific requirements in
these standards related to some of the most important COVID-19-
mitigation measures. The COVID-19 ETS addresses this issue by clearly
mandating each of these necessary protections.
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. As
explained in more detail in the Need for Specific Provisions (Section V
of the preamble), the infection control practices required to address
COVID-19 are most effective when used together, layering their
protective impact. Because no such layered framework is currently
enforced nationally, the existing standards leave large gaps in
employee protection from COVID-19. An ETS with a national scope that
contains provisions specifically addressing the COVID-19 hazards facing
healthcare workers will provide clearer instructions to the average
employer than the piecemeal application of existing standards. The ETS
bundles all of the relevant requirements, providing a roadmap for
employers and employees to use when developing a plan and implementing
protections, so that employers and employees in the settings covered by
this standard know what is required to protect employees from COVID-19.
More certainty will lead to more compliance, and more compliance will
lead to improved protection of employees.
Third, requirements in some existing standards may be appropriate
for other situations but simply do not contemplate COVID-19 hazards.
For example, as noted above, the Sanitation standard at Sec. 1910.141
requires employers to provide warm water, soap, and towels that can be
used for hand washing, an important protective action against COVID-19,
and generally requires that places of employment be kept ``clean,'' but
it does not specify disinfection as a cleaning procedure, even though
disinfection is an important precaution against COVID-19 transmission.
Nor does it require the provision of hand sanitizer where hand washing
facilities cannot be made readily available. Similarly, existing
standards do not address facemasks for a hazard such as COVID-19, which
protect other workers (source control) as well as provide some degree
of protection to the wearer. The ETS, developed in direct response to
the COVID-19 hazard and associated pandemic, provides this needed
specificity so the employers covered by the ETS understand exactly what
is required during this unprecedented public health emergency.
Fourth, the existing recordkeeping and reporting regulations are
not adequate to help the employer or the agency assess the full scope
of COVID-19 workplace exposures. The 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 workplace, it is critical that the employer has a record 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. The existing regulations are
premised on the assumption that employers can easily identify injuries
or illnesses that are work-related, but COVID-19 transmission can occur
in the workplace, the community, or the household, and it can be
difficult to identify the point of transmission. In numerous
investigations, OSHA has identified employee illnesses or deaths from
COVID-19 that were not reflected in the employer's required
recordkeeping logs because the employer was not able to determine
whether the illness or death was work-related. The COVID-19 log
required by the ETS will provide a fuller picture of the prevalence of
SARS-CoV-2 in the workplace by requiring employers to record employee
cases without a work-relatedness determination.
Furthermore, even where work-relatedness can be determined, the
existing reporting regulations are also inadequate in ensuring OSHA has
the full picture of the impact of COVID-19 in the settings covered by
this standard because the 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. But many COVID-19 infections will not
result in hospitalization or death until well after these limited
reporting periods; consequently they 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. In order to adequately understand and
thereby control the spread of COVID-19 in the workforce, it is critical
that the employer has a record of all cases of COVID-19 occurring among
employees and that OSHA is timely informed of all work-related COVID-19
in-patient hospitalizations and fatalities.
OSHA's existing recordkeeping and reporting requirements are also
inadequate for addressing the COVID-19 hazard in the workplaces covered
by the ETS because the current reporting structure does not require
employers to notify employees of possible exposures in the workplace.
While the recordkeeping requirements require employers to make illness
and injury records available to employees, 29 CFR 1910.35(b)(2), they
do not create an affirmative duty requiring employers to notify
employees when they may have been exposed to another employee with the
disease. Given the transmissibility of COVID-19, timely notification of
an exposure is critical to curbing further spread of COVID-19 and
protecting employees from the COVID-19 hazard.
Thus, OSHA's existing recordkeeping and reporting requirements are
not tailored to address hazards associated with COVID-19 in the
workplaces covered by the ETS. As a result, they do not enable OSHA,
employers, or employees to accurately identify and address such
hazards. The ETS addresses that issue by requiring employers to record
each instance identified by the employer in which an employee is COVID-
19 positive, regardless of whether the instance is connected to
exposure to COVID-19 at work; requiring employers to report work-
related, COVID-19 in-patient hospitalizations and fatalities,
regardless of when the exposure in the work environment occurred; and
imposing an affirmative duty requiring employers to notify employees of
COVID-19 exposure.
In conclusion, OSHA's experience has demonstrated that existing
standards alone are inadequate to address the COVID-19 hazard. The
limitations and inadequacies explained above prevent OSHA from
requiring all of the layers of controls necessary to protect employees
from COVID-19 under these existing standards, even in situations that
are clearly hazardous to employees. Thus, OSHA finds that its existing
standards are not sufficient to protect employees from the grave danger
posed by COVID-19.
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 his employees.'' 29 U.S.C. 654(a)(1). While
OSHA has attempted to use the General Duty Clause to protect employees
from COVID-19-related hazards, OSHA has found that there are
significant challenges associated with this approach and therefore this
ETS is necessary to protect the workers covered by this standard from
the grave danger posed by COVID-19. While the General Duty Clause can
be used in many contexts, in OSHA's experience over the past year, the
clause falls short of the agency's mandate to protect employees from
the hazards of COVID-19 in the settings covered by the standard. As
explained more fully below, OSHA finds the ETS will more efficiently
and effectively address those hazards. Cf. Bloodborne Pathogens, 56 FR
64004, 64007, 64038 (Dec. 6, 1991) (bloodborne pathogens standard will
more efficiently reduce the risk of the hazard than can enforcement
under the general duty clause).
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 COVID-19 plans, facemasks, distancing, barriers,
cleaning, personal protective equipment, and training, among other
things, and identifies the settings in which they are required.
Conveying obligations as clearly and specifically as possible provides
employers with enhanced notice of how to comply with their OSH Act
obligations to protect workers from COVID-19 hazards. See, e.g.,
Integra Health Mgmt., Inc., 2019 WL 1142920, at *7 n.10 (OSHRC 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 limit how effectively OSHA can use the clause to
address hazards associated with COVID-19. Most important, the General
Duty Clause is not a good tool for requiring employers to adopt
specific, overlapping, and complementary abatement measures, like those
required by the ETS, and some important worker-protective elements of
the ETS (such as payment for medical removal) would be virtually
impossible for OSHA to require and enforce 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, the ETS will enable OSHA to issue more meaningful penalties
for willful or egregious violations, thus facilitating better
enforcement and more effective deterrence against employers who
intentionally disregard their obligations under the Act or demonstrate
plain indifference to employee safety. Fourth, the General Duty Clause
does not provide complete protection to employees at multi-employer
worksites, which are common situations in hospitals, where more than
one employer controls hazards at the workplace. The ETS will permit
more thorough enforcement in these situations. Each of these is
discussed in more detail below.
General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
For contested 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).
For the first element of a General Duty Clause case, OSHA must
prove that there is a 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. In the case of COVID-19, 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 performing administrative tasks in a waiting room
setting where patients are seeking treatment for suspected or confirmed
COVID-19, create a 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 in the workplaces covered by this
standard (see Grave Danger, above), the ETS will eliminate the burden
to repeatedly prove the existence of a COVID-19 hazard in each
individual case 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 the cited workplace is hazardous.\16\ In contrast,
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 facial 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). In other words, the
General Duty Clause was not an effective tool because OSHA could not
prove that existing conditions at the cited workplace were hazardous.
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. 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 employee lives and health are unnecessarily
endangered by exposure to COVID-19. The ETS, on the other hand, allows
OSHA to cite employers for each protective requirement they fail to
implement without the need to prove in an enforcement proceeding that
the particular cited workplace was hazardous at the time of citation
without that particular measure in place.
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\16\ ``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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An additional limitation of the General Duty Clause is that it
requires OSHA to show that there was a feasible and effective means of
abating the hazard. To satisfy this element, OSHA is required to prove
that there are abatement measures that will be effective in materially
reducing the hazard. See Integra Health Management, 2019 WL 1142920, at
*12. Proving the existence of feasible abatement measures that will be
effective in materially reducing the hazard usually requires testimony
from an expert witness, which limits OSHA's ability to prosecute these
cases as broadly as needed to protect more workers. See, e.g., id. 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; instead, the employer bears
the burden of proving infeasibility as an affirmative defense. 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). Protecting as many
workers as quickly as possible is especially critical in the context of
COVID-19 because, as explained in Section IV.A, Grave Danger, it can
spread so easily in the workplaces covered by this ETS.
The General Duty Clause Is Ill-Suited to Requiring Employers To Adopt a
Comprehensive Set of Complementary Abatement Measures, Like Those
Required by the ETS
As explained in Section V. Need for the Specific Provisions of the
ETS, effective infection control programs use a suite of overlapping
controls in a layered approach to ensure that no inherent weakness in
any one approach results in an infection incident. Each of the
practices required by the ETS provides some protection from COVID-19 on
its own, but the practices must be used together to ensure adequate
worker protection. However, General Duty Clause enforcement poses key
obstacles that prevent OSHA from requiring the types of overlapping
controls necessary to address COVID-19 hazards. Because the General
Duty Clause requires OSHA to establish the existence and feasibility of
abatement measures that can materially reduce a hazard, it can be
difficult for OSHA to use 5(a)(1) to require a full suite of
overlapping or complementary control measures, or, in other words, to
require additional abatement measures in situations where an employer
is doing something, but not everything the ETS will require, to address
COVID-19 hazards.
In many cases over the past year where OSHA investigated COVID-19-
related complaints, the agency discovered that employers were following
some minimal mitigation strategy while ignoring other crucial
components of employee protection. In such instances, because the
employer had taken some steps to protect workers, successfully proving
a General Duty Clause citation would have required OSHA to show that
additional missing measures would have further materially reduced the
COVID-19 hazard. Although OSHA believes each measure required by this
ETS materially reduces the COVID-19 hazard, there are key challenges
inherent in trying to make such a showing in an individual case, such
as the difficulty of pinpointing exactly when and how employees could
become infected with COVID-19 and establishing the magnitude of the
effect particular abatement measures would have on reducing infection
in the specific conditions present in the employer's workplace. See,
e.g., Pepperidge Farm, Inc., 17 OSH Cas. (BNA) 1993, 1997 WL 212599, at
*51 (OSHRC No. 89-265, Apr. 26, 1997) (finding that additional feasible
abatement measure established by the Secretary to address ergonomic
hazard did not materially reduce the hazard in light of the other steps
the employer had taken). The ETS cures this problem by imposing
separate requirements for, and establishing the general effectiveness
of, each necessary mitigation measure, thereby ensuring employers have
an enforceable obligation to provide the full suite of workplace
protections recommended by the CDC and other expert bodies.
Consider a hospital setting where patients with suspected or
confirmed COVID-19 receive treatment. The employer requires respirators
for employees providing direct care to those patients but little else
to protect those employees or other workers in those settings who are
not directly involved in patient care. Under the ETS, OSHA can cite the
employer for violating the specific requirements necessary to protect
all workers in those settings, such as facemasks for workers who are
not directly caring for patients, physical distancing or barriers
between administrative employees and patients who have not yet been
screened for suspected or confirmed COVID-19, work practice controls
for employees performing aerosol-generating procedures on people with
suspected or confirmed COVID-19, patient screening and management, paid
leave for vaccination, and medical removal protection.
Without the ETS, however, OSHA would have to cite the employer
under the General Duty Clause for the much broader violation of failing
to eliminate the recognized workplace hazard of COVID-19 infection.
This would require OSHA to prove: (1) That the hazard of COVID-19
infection was present and recognized for employees at this particular
healthcare workplace, and (2) that additional abatement methods would
materially reduce the hazard, over and above the reduction achieved by
the use of respirators as already required under 29 CFR 1910.134 for
exposure to people with suspected or confirmed COVID-19. Both of these
elements would likely require expert witness testimony specific to
conditions in this particular workplace, and it may be difficult to
establish that each layer of protection necessary to comprehensively
protect employees would have materially reduced the hazard depending on
the facts of the specific instance.
Further, even where OSHA establishes a violation of the General
Duty Clause, the employer is under no obligation to implement the
precise 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 (OSHRC No. 76-616, Dec. 17, 1983). 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 adding
physical distancing or barriers, for example, could materially reduce
the hazard even further.
Finally, there are some crucial requirements in the ETS that OSHA
would have difficulty enforcing under the General Duty Clause. Of
particular note, OSHA is adopting provisions in the ETS that require
paid time for vaccination and recovery from vaccine side effects, and
removal of COVID-19-positive employees and other workers exposed to
them from the workplace and payment of salary for employees who are
removed (medical removal protection, or ``MRP''). These provisions are
critical to protecting workers because they facilitate vaccination,
which is the preferred means of protecting workers exposed to COVID-19
hazards, and removal of infected employees and their close contacts as
soon as the employer knows they have COVID-19. Additional discussion of
the importance of these provisions can be found in Section V. Need for
the Specific Provisions of the ETS. While it might be possible for OSHA
to establish the value of vaccination as a protective measure and the
need to remove known infected employees in a General Duty Clause case,
it is highly unlikely that OSHA could require payment to those
employees, or other measures to encourage employees to get vaccinated
or to let their employers know when they test positive for COVID-19.
Rather, paid leave for vaccination and MRP are measures better
implemented through OSHA's statutory authority to promulgate standards.
Standards are forward-looking and can be used to create a comprehensive
network of required, and in this case of layered, worker safety
protections. The ETS creates just such a network, and vaccination and
MRP are important layers of that approach.
The ETS Will 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, the ETS will clarify what exactly employers are
required to do to protect employees from COVID-19-related hazards,
making 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. 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, but not all, of the necessary steps to sufficiently address
the COVID-19 hazard. Given the current understanding that multiple
layers of protection are necessary to adequately protect workers from
COVID-19, an ETS will ensure that employers have clearer notice of
their obligations. This will allow the agency to take appropriate steps
to redress the situation where an employer has intentionally
disregarded the requirements necessary to protect employees from the
COVID-19 hazard, or has acted with plain indifference to employee
safety.
Further, OSHA has adopted its ``egregious'' policy to impose
sufficiently large penalties to 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 impact of OSHA's
enforcement ability. This policy uses OSHA's authority to issue a
separate penalty for each instance of willful 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 OSHA may only cite a hazardous condition once
under the General Duty Clause, regardless of its scope. 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 likely could not cite the
employer on a per-instance basis for failing to protect each of its
employees. A COVID-19-specific ETS will clarify the permissible units
of prosecution and thereby 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. Without a willful classification (or
a substantially similar prior violation), the maximum penalty for a
serious General Duty Clause violation is $13,653, regardless of the
scope of the hazard.
The General Duty Clause Provides Incomplete Protection at Multi-
Employer Worksites
Finally, the General Duty Clause has limited application to multi-
employer worksites like hospitals, as it cannot be used to cite an
employer whose own employees were not exposed to a hazard even if that
employer may have created, contributed to, or controlled the hazard.
See Solis v. Summit Contractors, Inc., 558 F.3d 815, 818 (8th Cir.
2009) (``Subsection (a)(1) [the General Duty Clause] creates a general
duty running only to an employer's own employees,
while subsection (a)(2) creates a specific duty to comply with
standards for the good of all employees on a multi-employer
worksite.''). For example, if a janitorial services contractor were to
send one employee who is COVID-19 positive into a healthcare setting
and knowingly allow that employee to work around employees of other
employers, the janitorial services contractor who created the hazard
could not be issued a General Duty Clause citation because none of that
employer's own employees would have been exposed to the hazard. This
limitation of the General Duty Clause can prevent OSHA from citing the
employer on a multi-employer worksite who may be the most responsible
for an existing COVID-19 hazard or best positioned to mitigate that
hazard.
For all of the reasons described above, OSHA finds that the General
Duty Clause is not an adequate enforcement tool to protect the
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 (January 29,
2021); and OSHA's earlier 35-page booklet, Guidance on Preparing
Workplaces for Covid-19 (March 9, 2020)). This guidance, as well as
guidance materials 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.\17\
Unfortunately, OSHA's experience shows that does not happen
consistently or rigorously enough, resulting in inadequate protection
for employees.
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\17\ Although the Centers for Medicare & Medicaid Services (CMS)
has issued regulations requiring healthcare employers that accept
payment through Medicare and Medicaid to implement nationally
recognized infection control practices (see 42 CFR Pts. 400-699),
those regulations do not obviate the need for this ETS. As a
preliminary matter, not all healthcare workplaces covered by the ETS
accept Medicare and Medicaid, and those that do not are not required
to comply with the CMS regulations. Furthermore, OSHA has important
enforcement tools that CMS lacks: OSHA can enforce a standard by
responding to complaints, conducting random unannounced inspections,
and issuing citations with penalties, whereas compliance with CMS
regulations is generally validated through periodic accreditation
surveys. The joint effect of the CMS regulations and a new ETS would
improve the breadth, quality and implementation of infection control
programs in a manner that the CMS regulations cannot do, and have
not done, alone. Indeed, that has been OSHA's experience in
enforcing its existing standards against healthcare employers that
overlap with CMS requirements, such as the Respirator, PPE, and
Bloodborne Pathogens standards. Thus, the ETS is necessary to
provide additional coverage and enforcement tools above and beyond
the CMS regulations.
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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). 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. 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.
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). Several other factors have also been
found to contribute to uneven implementation of controls to prevent the
spread of COVID-19. For example, there has been a reported rise of
``COVID fatigue'' or ``pandemic fatigue''--i.e., a decrease in
voluntary use of COVID-19 mitigation measures over time (Silva and
Martin, November 14, 2020; Meichtry et al., October 26, 2020; Belanger
and Leander, December 9, 2020). In addition, the 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, may also play a role in the uneven implementation of
COVID-19 mitigation measures (Belanger and Leander, December 9, 2020;
Markman, April 20, 2020).
The high number of COVID-19-related complaints and reports also
suggests a lack of widespread compliance with existing voluntary
guidance. Although the number of employee complaints is declining, OSHA
continues to receive hundreds of complaints every month, including
complaints alleging that healthcare employers are not consistently
following non-mandatory CDC guidance to protect employees. 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 toward the end of 2020 and in early 2021 indicated
a continued risk of COVID-19 spread in workplace settings (for more
information on the prevalence of COVID-19 see Grave Danger (Section
IV.A of the 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). The ETS is one aspect of the national response to the pandemic
that is needed to improve compliance with infection control measures by
establishing clear, enforceable measures that put covered employers on
notice that they must,
rather than should, take action to protect their employees. For these
reasons, OSHA finds that non-mandatory guidance efforts are not
sufficient, by themselves or in conjunction with General Duty Clause
enforcement, to protect employees covered by this ETS from being
infected by, and suffering death or serious health consequences from,
COVID-19.
d. A Uniform Nationwide Response to the Pandemic Is Necessary To
Protect Workers
OSHA is charged by Congress with protecting the health and safety
of American workers. Yet OSHA's previous approach proved ineffective in
meeting that charge. While some states and localities stepped in to
fill the gaps in employee protection, these approaches do not provide
consistent protection to workers and have, in some cases, been relaxed
prematurely, leading to additional outbreaks (Hatef et al., April
2021). In some states there are no workplace requirements at all. OSHA
has determined that a Federal standard is needed to ensure sufficient
protection for employees in all states in the settings covered by this
ETS; clarity and consistency about the obligations employers have to
protect their employees in these settings; and a level playing field
among employers.
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). One of the justifications for OSHA standards has always been
to ``level the playing field'' so that employers who proactively
protect their workforces are not placed at a competitive disadvantage
(Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 521 n.38 (1981)).
Many employers have advised OSHA that they would welcome a nationwide
ETS for that reason. 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. While noting that ``OSHA
could not pre-empt a State from keeping its own rule (assuming it is
`at least as effective' as OSHA's standard),'' they also observed that
``historically, the impact of federal rulemaking in similar situations
(e.g., HazCom) has been that most, if not all, of the States ultimately
adhere to the federal requirements . . . . That can only be
accomplished if OSHA takes the lead'' (id.). ``Without an ETS,'' they
continue, ``employers are left on their own to determine the preventive
measures that need to be undertaken'' (id.).
Given that thousands of healthcare employees each week continue to
be infected with COVID-19, 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, and
that an ETS is necessary to provide clear and consistent protection to
covered employees across the country.
e. OSHA's Other Previous Rationales for Not Promulgating an ETS No
Longer Apply
In addition to asserting that existing standards, guidance, and the
General Duty Clause would provide sufficient tools to address COVID-19
hazards to employees, OSHA had previously cited the need to respond to
evolving scientific knowledge about the virus as part of its rationale
for not issuing an ETS during the late spring of 2020. Knowledge of the
nature of COVID-19 was undoubtedly less certain at the beginning of the
pandemic when OSHA made its initial determination that an ETS was not
necessary. There have been recent changes in CDC recommendations for
vaccinated people outside the healthcare context. However, for
unvaccinated workers, since the summer of 2020 there has been
considerable stability in the guidance from the CDC and other health
organizations regarding the basic precautions that are essential to
protect unvaccinated people from exposure to COVID-19 while indoors.
And the CDC still recommends these precautions to protect vaccinated
workers in healthcare settings. For example, the CDC's COVID-19
guidance on How to Protect Yourself & Others (CDC, March 8, 2021)
includes the same guidance it issued in July 2020 regarding the basic
protections of face coverings, distancing, barriers, and hand hygiene.
Moreover, OSHA's previous concern--that an ETS would unintentionally
enshrine requirements that are subsequently proven ineffective in
reducing transmission--has proven to be overstated. Moreover, even
after issuing an ETS OSHA retains the flexibility to update the ETS to
adjust to the subsequent evolution of CDC workplace guidance. The major
development in infection control over the last year--the development,
authorization, and growing distribution and use of COVID-19 vaccines--
is addressed in the ETS. Going forward, further developments can be
addressed through OSHA's authority to modify the ETS if needed, or to
withdraw it entirely if vaccination and other efforts end the current
emergency. Nothing in the D.C. Circuit's decision in In re Am. Fed'n of
Labor & Cong. of Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO,
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 its most severe effects had not yet been
experienced, the court decided not to second-guess OSHA's decision to
hold off on regulation in order to see if its non-regulatory
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 ``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).
Finally, it is worth noting that OSHA's conclusion as to the
ineffectiveness of the current approach--i.e., relying on existing
enforcement tools and voluntary guidance--is supported by a report
issued by the DOL Office of Inspector General, dated February 25, 2021,
which concluded after an investigation that OSHA's prior approach to
addressing the hazards of COVID-19 leaves employees across the country
at increased risk of COVID-19 infection (DOL OIG, February 25, 2021).
The DOL OIG report specifically recommended that OSHA reconsider its
prior decision not to issue an ETS to provide the necessary protection
to employees from the hazards of COVID-19.
f. Even in Combination, the Guidance and General Duty Clause Are Still
Inadequate
Early in the pandemic, OSHA took the position that existing
standards, together with the combination of non-mandatory guidance and
General Duty Clause citations, would be sufficient to protect employees
so that specific mandatory requirements would not be necessary. In
theory, where existing standards did not address an issue directly, the
remaining regulatory gap could be filled by guidance from OSHA,
which would provide notice of COVID-19 hazards and describe feasible
means of abating them, enabling OSHA to later issue a General Duty
Clause citation to an employer who had failed to follow that guidance.
OSHA's enforcement experience has now disproven that theory. As
explained above, existing standards leave an enormous regulatory gap
that OSHA's guidance, together with the General Duty Clause, cannot
cover for the settings covered by this ETS.
In practice, the combination of guidance and General Duty Clause
authority has done little to protect employees in settings covered by
the standard where employers were not focused on that goal. The
limitations identified above, including the heavy litigation burden for
General Duty Clause citations, remain. Instead of being able to rely on
clear requirements in a standard, employers were left to wade through
guidance not only from OSHA but also from multiple other agencies,
states, media, and other sources without any clarity as to how the
different guidance materials should work together or what to do when
alternative guidance did not square with OSHA's guidance. Perhaps
because OSHA's guidance was not mandatory, it was frequently ignored or
followed only in part. As explained above, the General Duty Clause's
shortcomings as an enforcement tool left OSHA, in most cases,
ultimately unable to impose all of the layers of protection necessary
to protect employees from COVID-19.
In sum, based on its enforcement experience during the pandemic to
date, OSHA concludes that continued reliance on existing standards,
together with the combination of guidance and General Duty Clause
obligations, in lieu of an ETS, will not protect employees covered by
this ETS against the grave danger posed by COVID-19.
g. Recent Vaccine Developments Demonstrate the Importance of the ETS;
They Do Not Obviate the Current Need for an ETS
The development and availability of safe and highly effective
vaccines is an important development in the nation's response to COVID-
19. The very low percentage of breakthrough cases (illness among
vaccinated people) have led to recent updates to CDC guidance
acknowledging vaccination as an effective control to prevent
hospitalization and death from COVID-19 to such an extent that the CDC
has concluded that most other controls are not necessary to protect
vaccinated people outside healthcare settings. In the United States,
all people ages 12 and older are eligible to be vaccinated, and
vaccines are readily available in most parts of the country.
However, despite the remarkable success of our nation's vaccine
program and the substantial promise that vaccines hold, as explained
below, OSHA does not believe they eliminate the need for this standard.
OSHA embraces the value of vaccination and views the ETS as essential
to facilitating access to this critical control for those workers who
wish to receive it while still protecting those who cannot be, or will
not be, vaccinated. And by excluding certain workplaces and well-
defined work areas where all employees are fully vaccinated from all
requirements of the standard (paragraphs (a)(2)(iv) and (v)), and
exempting fully vaccinated workers in certain settings where not all
employees are vaccinated from several requirements of the standard
(paragraph (a)(4)), the ETS encourages vaccination for employers and
employees who do not want to follow those requirements.
In addition, for vaccines to be effective, workers need first to
actually receive them. While the supply of vaccines and their
distribution continues to increase, as of the date of the promulgation
of this standard, approximately a quarter of healthcare workers have
not yet completed COVID-19 vaccination with many of those expressing
vaccine hesitation (King et al., April 24, 2021). Although a majority
of Americans over 65 are vaccinated, the percentage among the working-
age population is much lower (44%) (CDC, May 24, 2021a). There are
several barriers to vaccination for the working-age population. Many
employees who want to be vaccinated may be unable to do so unless the
employer authorizes time off work, or may be financially unable to
absorb a reduced paycheck for taking unpaid leave to be vaccinated or
potentially missing a significantly larger period of time from work
(and a larger financial hit) because of the potential side effects of
the vaccination (SEIU Healthcare, February 8, 2021). A recent Kaiser
Foundation survey of people who expressed reluctance to be vaccinated
indicates that 70% of those respondents (76% and 77% among Black and
Latinx respondents, respectively) were concerned about side effects,
and 45% (57% Black and 54% Latinx) cited fears that they might miss
work if the side effects made them sick (KFF, May 6, 2021). Another
recent study, which surveyed 500 businesses, found that paid time off
for vaccination and recovery was the highest overall motivator for
employees to get vaccinated (51%), which was even higher than employers
offering the vaccine on site (49%) (Azimi et al., April 9, 2021). Yet a
different report indicates that before the pandemic, about 70% 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 (Gould, February 28, 2020).
Despite the American Rescue Plan (ARP) extending tax credits for some
employers to allow this sort of sick leave, such leave is not mandated.
Those surveys are consistent with the experience among healthcare
workers at Yale University and Yale New Haven Hospital. When workers
were surveyed at the time the FDA granted Emergency Use Authorization
of the Pfizer-BioNTech vaccine, the lack of incentives or mitigation of
risk (e.g., not using sick days or pay loss for side effects) was a key
reason stated by people who identified themselves as unlikely to get
the vaccine. (Roy et al., December 29, 2020). Following four months of
vaccination efforts, researchers found that although 75% had been
vaccinated, roughly half of low wage, hourly employees, had not yet
been vaccinated, and based on their previous research, identified the
provision of additional paid sick leave days as a critical barrier for
this population of workers (Roy and Forman, April 7, 2021). Even when
employees can arrange for time off for the first dose, some of the same
difficulties may prevent workers from returning during the designated
time window for the second dose of two-dose vaccines. The ETS addresses
these obstacles with a requirement that employers must authorize paid
leave to cover the time for vaccination and for recovery from side
effects.
Further, there is a need to continue building vaccine confidence in
some parts of the population, making the ETS even more important to
assure safe working conditions during the period before these workers
are vaccinated. Moreover, as discussed in more depth in Grave Danger
(Section IV.A. of the preamble), even though vaccines are now more
readily available, they do not protect all workers. Some workers are
unable to be vaccinated for medical or other reasons, even if they are
willing to be. And in immunocompromised workers, vaccines can be
considerably less effective than in immunocompetent individuals.\18\
And while some
employees may simply elect not to be vaccinated for personal reasons,
OSHA has a statutory duty to ensure that employers protect those
employees from the grave danger of COVID-19 regardless of their basis
for refusing vaccination.
---------------------------------------------------------------------------
\18\ There is concern that vaccines may not be effective for
immunocompromised individuals. A study evaluating 67 individuals
with blood cancers found that 46% of them did not generate an immune
response despite being fully vaccinated (Agha et al., April 7,
2021). Almost three quarters of those with chronic lymphocytic
leukemia were non-responsive. A study on 658 transplant recipients
found that 46% of recipients did not develop an immune response,
including 18% of those not on an immunosuppression regimen and 33%
of those who received their transplant more than 12 years prior
(Boyarsky et al., May 5, 2021). A study on those with chronic
inflammatory disease found a three-fold reduction in immune response
generated by vaccination in comparison to immunocompetent adults,
including a 36 fold reduction for those receiving B cell depletion
therapies (Deepak et al., April 9, 2021). Furthermore, the
Australian Agency for Clinical Innovation issued a summary detailing
significant concerns about the efficacy for vaccination for
immunocompromised persons and need for these individuals to continue
using non-pharmaceutical interventions (ACI, April 28, 2021). While
vaccines are a highly effective tool to minimize infections, it
cannot be overlooked that it is likely not an effective means of
control for all individuals.
---------------------------------------------------------------------------
These factors, along with the uneven vaccination rates among some
sub-populations, make the need for this ETS especially acute. For
example, the Latinx and Black populations who have been
disproportionately harmed by the virus also have the lowest vaccination
rates (Ndugga et al., February 18, 2021; CDC, May 24, 2021a). This ETS
can help facilitate vaccination among those groups, protect those who
cannot or will not be vaccinated, and thereby mitigate the
disproportionate impacts of the virus for workers in these groups.
Even when the ETS helps currently unvaccinated workers overcome the
obstacles to becoming vaccinated, they must still be protected by the
other measures of this standard until they are fully protected by the
vaccine. With the two-dose vaccines in particular, the time from a
first shot to fully effective vaccination is 5 to 6 weeks.
Furthermore, also increasing are new virus variants, the most
prevalent of which, the B.1.1.7 variant first identified in the U.K.,
now appears responsible for almost 66% of the cases in the U.S (CDC,
May 24, 2021b). While the currently authorized vaccines appear
effective against all of the variants now circulating, promoting
vaccination as quickly as possible becomes even more critical because
the variant is not only more transmissible, it also appears to cause
more severe disease.
Finally, while the science continues to develop, the full extent
and duration of the immune response remains unknown. Additional
evidence is also needed to determine the extent to which people who are
vaccinated could still be infected and transmit the disease to others,
even if they themselves are protected from the worst health effects.
Although such cases do not appear to be common, the ETS would help
protect these employees and their co-workers in mixed groups of
vaccinated and unvaccinated people.
These issues, as elaborated further in the discussion of Grave
Danger, demonstrate that the various protections required in this ETS
are still necessary, even for workplaces in which many but not all
members of the workforce have been vaccinated.
This pandemic has taken a devastating toll on all of American
society, and addressing it requires a whole-of-government response
(White House, April 2, 2021). 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 also recognizes that measures to
mitigate the spread of COVID-19, including encouraging and facilitating
vaccination, are still necessary in the settings covered by this
standard. However, although OSHA finds it necessary to continue these
mitigation measures for the immediate future, the agency will adjust as
conditions change. As more of the workforce becomes vaccinated and the
post-vaccination evidence base continues to grow, and the CDC updates
its guidance, OSHA will withdraw or modify the ETS to the extent the
workplace hazard is substantially diminished in the settings covered by
this ETS. However, at this point in time, the available evidence
indicates that the ETS is still necessary to protect employees in the
settings covered by this ETS, and the potential for higher immunity
rates later on does not obviate the need to implement the ETS now.
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at Increased Risk. http://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021).
World Health Organization (WHO). (2009). WHO Guidelines on Hand
Hygiene in Health Care: A Summary--First Global Patient Safety
Challenge Clean Care is Safer Care. (WHO, 2009).
The White House. (2021, April 2). Press Briefing by White House
COVID-19 Response Team and Public Health Officials. https://www.whitehouse.gov/briefing-room/press-briefings/2021/04/02/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-23/. (The White House, April 2, 2021).
V. Need for Specific Provisions of the ETS
Grave Danger (Section IV.A. of the preamble) identifies the danger
of exposure to SARS-CoV-2 for healthcare workers and explains how the
SARS-CoV-2 virus is transmitted. This section, on Need for Specific
Provisions, examines the scientific underpinnings for the controls that
OSHA has identified to stop that transmission in workplaces. In Section
VIII, the Summary and Explanation for the various provisions of the
ETS, OSHA
explains how those controls must be implemented in the workplace. Not
all of the requirements of the ETS are examined in this Need for
Specific Provisions section. Some are addressed fully in the Summary
and Explanation sections.
A. Introduction--Effective Infection Prevention Utilizes Overlapping
Controls
An effective infection prevention program utilizing a suite of
overlapping controls in a layered approach better ensures that no
inherent weakness in any one approach results in an infection incident.
OSHA emphasizes that each of the infection prevention practices
required by the ETS provide some protection from COVID-19 by
themselves, but work best when used together, layering their protective
impact to boost overall effectiveness. A common depiction of this
approach in use is Reason's model of accident causation dynamics, more
commonly referred to as the ``Swiss Cheese Model of Accident
Causation'' (Reason, April 12, 1990). Reason combined concepts of
pathogen transmission and airplane accidents to present a model that
illustrated that accidents are the result of the interrelatedness of
imperfect defenses and unsafe actions that are largely unobservable
until an adverse outcome becomes apparent. Using the Swiss cheese
analogy, each control has certain weaknesses or ``holes.'' The
``holes'' differ between different controls. By stacking several
controls together with different weaknesses, the ``holes'' are blocked
by the strengths of the other controls. In other words, if controls
with different weaknesses are layered, then any unexpected failure of a
single control is protected against by the strengths of other controls.
The model provides a guiding approach to reduce incidents across many
sectors (Reason et al., October 30, 2006) and that perspective is
reflected in widely accepted approaches to controlling infectious
diseases (HICPAC, January 1, 1996; Rusnak et al., July 31, 2004; CDC,
2012; WHO, 2016).
The CDC Healthcare Infection Control Practices Advisory Committee's
(HICPAC) Isolation Guidelines, which apply to healthcare settings, are
an example of established national guidelines that illustrate layered
controls to prevent the transmission of infectious diseases (Siegel et
al., 2007). The Isolation Guidelines recommend two tiers of
precautions: Standard Precautions and Transmission-Based Precautions
(e.g., airborne, droplet, contact). Standard Precautions, under the
Isolation Guidelines, are the minimum infection prevention practices
that apply to patient care, regardless of the suspected or confirmed
infection status of the patient, in any setting where health care is
practiced. They are based on the principle that there is a possible
risk of disease transmission from any patient, patient sample, or
interaction with infectious material. For Standard Precautions,
guidance follows that a certain set of controls should be implemented
to reduce infectious disease transmission regardless of the diagnosis
of the patient, in part because there is always baseline risk that is
not necessarily either obvious or detectable. These precautions include
controls such as improved hand hygiene, use of personal protective
equipment, cleaning of equipment, environmental controls, handling of
bed linens, changing work practices, and patient placement. When used
in concert, these approaches protect workers from potential exposure to
infectious agents.
The Isolation Guidelines' second tier of precautions, Transmission-
Based Precautions, takes into consideration the transmission mechanism
of specific diseases and complements Standard Precautions to better
protect workers from the presence of known or suspected infectious
agents. For instance, SARS-CoV-2, the infectious agent that causes
COVID-19, is considered to be mainly transmissible through the droplet
route in most settings (though there is evidence for airborne
transmission as noted throughout this preamble). Droplet transmission
occurs by the direct spray of large droplets onto conjunctiva or mucous
membranes (e.g., the lining of the nose or mouth) of a susceptible host
when an infected person sneezes, talks, or coughs. Droplet precautions
are a suite of layered controls that are designed to prevent the direct
spray of infectious material and supplement the suite of layered
controls used for Standard Precautions. They are designed to protect
workers from infectious agents that can be expelled in large
respiratory droplets from infected individuals. These added
interventions are implemented when infection is known or suspected and
include placing patients in single rooms or physically distant within
the same room, increased mask usage, and limiting patient movement.
COVID-19 is considered capable of spreading through multiple routes of
transmission, including airborne. Thus, the CDC recommends respiratory
protection, isolation gowns, and gloves in healthcare settings to
protect workers in those settings.
While a suite of layered controls is appropriate for controlling
infectious diseases, it is important to use the hierarchy of controls
when choosing which controls to include and the order in which to
implement them. Briefly, the hierarchy of controls refers to the
concept that the best way to control for hazards is to preferentially
utilize the most effective before complementing with less effective
controls.\19\ Ideally, the hazard is eliminated, which would likely
mean using an option such as conducting a telehealth visit outside of a
patient care setting with respect to COVID-19 to ensure that there is
no shared workspace and thus no potential for employee exposure to
COVID-19. When a telehealth visit is not possible, workers must be
protected through the implementation of controls. Outside the realm of
infection control, the utilization of an engineering control or a
change in on-site work practices could alone effectively minimize a
hazard in many cases. However, infection prevention failures often are
not apparent until an outbreak occurs, resulting in many infected
workers. Therefore, it is important for employers to not only adhere to
the hierarchy of controls when identifying controls to implement, but
also to augment layers of feasible engineering controls (e.g., adequate
ventilation, barriers) with administrative and work practice controls
(e.g., physical distancing, cleaning, disinfection, telework, schedule
modification, health screening). Personal protective equipment (e.g.,
gloves, respirators, and facemasks) can provide the final layer of
control. This approach is consistent with both OSHA and CDC guidance
for protecting workers and the public from COVID-19.
---------------------------------------------------------------------------
\19\ The hierarchy of controls is a longstanding occupational
safety practice and OSHA policy. Under its hierarchy of controls
policy reflected in a number of standards, OSHA typically only
allows employers to rely on respirators or other PPE to the extent
that engineering controls to eliminate the hazard are not feasible.
See, e.g., Sec. Sec. 1910.134(a) (respiratory protection) and
1926.103 (respiratory protection); 1910.1000(e) (air contaminants);
1910.95(b) (occupational noise exposure) and 1926.101 (hearing
protection).
---------------------------------------------------------------------------
In addition to the broad recognition and implementation of layered
controls to protect against infectious diseases, a recent study
elucidated the effectiveness of isolated and layered controls, with
respect to close contacts amidst several community COVID-19 outbreaks
in Thailand (Doung-ngern et al., September 14, 2020). While individual
controls, such as wearing a face covering or maintaining at least a
minimum distance from others, significantly reduced cases (28% and 40%,
respectively), the researchers concluded
that a layered approach would be expected to reduce infections by 84%.
Several similar studies evaluated the importance of layering
controls during the 2002/2003 SARS outbreak caused by SARS-CoV-1, which
is a different strain of the same species of virus as the virus that
causes COVID-19 (SARS-CoV-2) and has some similar characteristics;
importantly, both viruses are strains of the same viral species and
exhibit the same modes of transmission. Researchers assessed five Hong
Kong hospitals on how the utilization of interventions affected SARS
transmission (Seto et al., May 3, 2003). In total, the study evaluated
244 workers on their compliance with wearing masks, gowns, and gloves
as well as adhering to hand hygiene protocols. Among the 69 workers who
fully complied with the layered controls, there were no infections.
However, 13 of 185 workers who used only some of the interventions were
infected. The researchers concluded that the combined practice of
droplet and contact precautions together significantly reduced the risk
of infection from exposures to SARS-infected individuals.
Another study investigated the approaches taken to reduce SARS-CoV-
1 transmission in hospitals in Taiwan during the 2003 portion of the
outbreak (Yen et al., February 12, 2010). Researchers surveyed forty-
eight Taiwanese hospitals that provided care for 664 SARS-CoV-1
patients, including 119 healthcare workers, to determine which controls
each hospital implemented. Control measures included isolation of fever
patients in the Emergency Department (ED), installation of handwashing
stations in the ED, routing patients from the ED to an isolation ward,
installation of fever screen stations in the ED, and installation of
handwashing stations throughout the hospital. Analysis showed that
while early SARS-CoV-1 case identification at fever screening stations
outside the hospital could reduce transmission inside the hospital by
half, combining that intervention with other interventions could almost
double that reduction.
A modeling effort to simulate an epidemic of seasonal influenza at
a hypothetical hospital in Ann Arbor, Michigan, found that different
interventions used in a layered approach would result in a greater
predicted reduction in nosocomial cases (i.e., healthcare-associated
infections) (Blanco et al., June 1, 2016). The study evaluated six
different intervention techniques thought to be effective against
influenza, including hand hygiene, employee vaccination, patient pre-
vaccination, patient isolation, therapies (e.g., antibody treatments,
steroids), and face coverings. The researchers found, based on the
model, that while no individual intervention exceeded a 27% percent
reduction in cases, utilizing all controls would prevent half of all
cases. While this model employed influenza as the vehicle to examine
the effectiveness of layered protections, it gives no reason to believe
that this approach would not be equally effective for other viruses
such as SARS-CoV-2.
In 2016, the World Health Organization, a specialized agency of the
United Nations that is focused on international public health (WHO,
2016), addressed the use of layering interventions to reduce infections
in performed systematic reviews in its ``Guidelines on Core Components
of Infection Prevention and Control Programmes at the National and
Acute Health Care Facility Level.'' OSHA's perspective of layered
interventions (e.g., engineering controls, work practice controls,
personal protective equipment, training) is consistent with what the
WHO Guidelines define as ``multimodality.'' WHO defines multimodality
as follows:
A [layered] strategy comprises several elements or components
(three or more; usually five, http://www.ihi.org/topics/bundles/Pages/default.aspx) implemented in an integrated way with the aim of
improving an outcome and changing behavior. It includes tools, such
as bundles and checklists, developed by multidisciplinary teams that
take into account local conditions. The five most common components
include: (i) System change (availability of the appropriate
infrastructure and supplies to enable infection prevention and
control good practices); (ii) education and training of health care
workers and key players (for example, managers); (iii) monitoring
infrastructures, practices, processes, outcomes and providing data
feedback; (iv) reminders in the workplace/communications; and (v)
culture change within the establishment or the strengthening of a
safety climate.
The WHO guidelines strongly recommend practicing multimodality/
layered interventions to reduce infections based on WHO's systematic
review of implementation efforts at facility-level and national scales.
Based on a systematic review of 44 studies on implementing infection
control practices at the facility level, and another systematic review
of 14 studies on the success of National rollout programs using layered
strategies, WHO concluded that using layered strategies was effective
in improving infection prevention and control practices and reducing
hospital-acquired illnesses (WHO, 2016).
Vaccination does not eliminate the need for layered controls for
healthcare workers exposed to COVID-19 patients, which can result in
exposures that are more frequent and potentially carrying higher viral
loads than those faced in workplaces not engaged in COVID-19 patient
care. The Director of the CDC's National Institute for Occupational
Health (NIOSH) recently wrote to OSHA that layers of control are still
needed for vaccinated healthcare workers who remain at ``particularly
elevated risk of being infected'' while treating COVID-19 patients:
``The available evidence shows that healthcare workers are continuing
to become infected with SARS-CoV-2, the virus that causes COVID-19,
including both vaccinated and unvaccinated workers . . . Regardless of
vaccination status, healthcare workers need additional protections such
as respirators and other personal protective equipment (PPE) during
care of patients with suspected or confirmed COVID-19.'' (Howard, May
22, 2021). Further, a recent CDC study found that despite the positive
impact on the roll-out of large-scale vaccination programs on reducing
the transmission of COVID-19, a decline in non-pharmaceutical
interventions (NPIs; e.g., physical distancing, face covering use) may
result in a resurgence of cases (Borchering, May 5, 2021). The authors
concluded that vaccination coverage in addition to compliance with
mitigation strategies are essential to minimize COVID-19 transmission
and prevent surges in hospitalizations and deaths. Thus, to effectively
control COVID-19 transmission to those who are not vaccinated or
immune, an increase in vaccination coverage in addition to NPIs, such
as physical distancing, are crucial.
Based on the above evidence, OSHA is requiring in the ETS that
healthcare employers must not only implement the individual infection
prevention measures discussed in the following sections, but also layer
their controls to protect workers from the COVID-19 hazard due to the
additional protection provided to workers when multiple control
measures are combined.
References
Blanco, N et al., (2016, June 1). What Transmission Precautions Best
Control Influenza Spread in a Hospital. American Journal of
Epidemiology 183 (11): 1045-1054. https://doi.org/10.1093/aje/kwv293. (Blanco et al., June 1, 2016).
Borchering, RK et al., (2021, May 5). Modeling of Future COVID-19
Cases, Hospitalizations, and Deaths, by Vaccination Rates and
Nonpharmaceutical Intervention Scenarios--United States, April-
September 2021. MMWR Morb Mortal Wkly Rep. ePub: 5 May 2021. doi:
http://dx.doi.org/10.15585/mmwr.mm7019e3. (Borchering, May 5, 2021).
Centers for Disease Control and Prevention (CDC). (2012). An
Introduction to Applied Epidemiology and Biostatistics, Lesson 1:
Introduction to Epidemiology, Section 10: Chain of Infection. In:
Principles of Epidemiology in Public Health Practice, Third Edition:
http://www.cdc.gov/ophss/csels/dsepd/SS1978/Lesson1/Section10.html.
(CDC, 2012).
Doung-ngern, P et al., (2020, September 14). Case-control Study of
Use of Personal Protective Measures and Risk for SARS Coronavirus 2
Infection, Thailand. Emerg In Dis 26, 11: 2607-2616. https://doi.org/10.3201/eid2611.203003. (Doung-ngern et al., September 14,
2020) .
Hospital Infection Control Practices Advisory Committee (HICPAC).
(1996, January 1). Guideline for isolation precautions in hospitals.
Infection Control and Hospital Epidemiology 17(1): 53-80. (HICPAC,
January 1, 1996).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
Reason, J. (1990, April 12). The Contribution of Latent Human
Failures to the Breakdown of Complex Systems. Philosophical
Transactions of the Royal Society London B327475 B327484. https://dol.org/10.1098/rstb.1990.0090. (Reason et al., April 12, 1990).
Reason, J et al., (2006, October 30). Revisiting the Swiss Cheese
Model of Accidents. EUROCONTROL Experimental Centre, Note No. 13/06.
(Reason et al., October 30, 2006).
Rusnak, JM et al., (2004, July 31). Management guidelines for
laboratory exposures to agents of bioterrorism. Journal of
Occupational and Environmental Medicine 46(8): 791-800. doi:
10.1097/01.jom.0000135536.13097.8a. (Rusnak et al., July 31, 2004).
Seto, WH et al., (2003, May 3). Effectiveness of precautions against
droplets and contact in prevention of nosocomial transmission of
severe acute respiratory syndrome (SARS). The Lancet 361(9368):
1519-1520. https://doi.org/10.1016/s0140-6736(03)13168-6. (Seto et
al., May 3, 2003).
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).
World Health Organization (WHO). (2016). Guidelines on Core
Components of Infection Prevention and Control Programmes at the
National and Acute Health Care Facility Level. https://www.who.int/gpsc/ipc-components-guidelines/en/. (WHO, 2016).
Yen, MY et al., (2010, February 12). Quantitative evaluation of
infection control models in the prevention of nosocomial
transmission of SARS virus to healthcare workers: implication to
nosocomial viral infection control for healthcare workers.
Scandinavian Journal of Infectious Diseases 42: 510-515. https://10.3109/00365540903582400. (Yen et al., February 12, 2010).
B. COVID-19 Plan
An effective COVID-19 plan is modeled on the core components of
safety and health programs, which utilize a systematic approach to
reduce injuries and illnesses in the workplace. The occupational safety
and health community uses various names to describe this type of
systematic approach (e.g., safety and health programs, safety and
health management systems, and injury and illness prevention programs)
and uses the terms ``plans'' and ``programs'' interchangeably. An
effective safety and health program involves proactively and
continuously identifying and mitigating hazards, before employees are
injured or develop disease. The approach involves trained employees and
managers working together to identify and address issues before the
issues become a problem. Such an approach helps employers meet their
obligation under the OSH Act to provide employees a place of employment
free from recognized hazards (OSHA, January 2012; OSHA, October 18,
2016). The COVID-19 plan required by this ETS encompasses the core
components of this type of safety and health programs. Developing and
implementing a COVID-19 plan is an essential part of an effective
response to the COVID-19 hazards present in the workplace because the
process involves identifying employees who are at risk of exposure to
the virus and determining how they can be effectively protected from
developing COVID-19 using a multi-layered approach.
Many companies that have received awards for their safety and
health accomplishments have credited safety and health programs for
their success. Because of the value, effectiveness, and feasibility of
such programs, many countries throughout North America, Asia, and
Europe require employers to implement programs to prevent injury and
illness. Numerous studies and data sources provide evidence of such
programs improving safety and health management practices and
performance which leads to reductions in injury, illness, and
fatalities. For example, a review of the impact of implementation of
safety and health programs in eight states showed a reduction of injury
and illness rates ranging from 9% to more than 60% (OSHA, January
2012). In three of these states with mandatory injury and illness
prevention programs, workplace fatality rates were up to 31% lower than
the national average (OSHA, January 2012).
OSHA has traditionally identified seven core elements of successful
safety and health programs including (1) management leadership, (2)
worker participation, (3) hazard identification and assessment, (4)
hazard prevention and controls, (5) evaluation and improvement, (6)
coordination and communication at multi-employer sites, and (7)
education and training (OSHA, January 2012; OSHA, October 18, 2016).
The COVID-19 plan required by this ETS was developed with these
elements in mind. The first core element, management leadership,
involves a demonstrated commitment to establishing a safety and health
culture and continuously improving safety and health in the workplace.
A commitment to health and safety is demonstrated by implementing a
clear plan for preventing illness and injury, and communicating the
plan to all employees (including contractors and temporary staff).
Designating a coordinator to track progress of the plan and ensure that
all aspects of the plan are implemented further demonstrates
management's commitment to employee safety and health (OSHA, 2005;
OSHA, January 2012; OSHA, October 18, 2016).
The second, and one of the most important components of a safety
and health program, is the participation of trained and knowledgeable
employees, including those employed by other employers (e.g.,
contractors, temporary staff). Employees provide unique perspective and
expertise because they are often the most knowledgeable people about
the hazards associated with their jobs and how those hazards can be
controlled. Employees who are trained to recognize hazards and
appropriate controls to address those hazards and know that they can
speak freely to employers, can provide valuable input on hazards that
need to be addressed, which can lead to a reduction in hazards or
exposure to hazards. They can also provide input on improvements that
are needed to protections that have already been implemented. An
emphasis on employee participation is consistent with the OSH Act, OSHA
standards, and
OSHA enforcement policies and procedures, which recognize the rights
and roles of workers and their representatives in matters of workplace
safety and health (OSHA, 2005; OSHA, January 2012; OSHA, October 18,
2016).
The third core element of a safety and health program approach is
hazard identification and assessment. To be most effective, hazard
assessments must be conducted as a team approach with management,
coordinators, and employees involved in the hazard assessment process
(e.g., identifying potential hazards) and the development and
implementation of the COVID-19 plan. An assessment to identify safety
and health hazards can include surveying the facility to observe
employee work habits and evaluating employee input from surveys or
meeting minutes. Specifically, the risk of exposure to biological
hazards, such as the COVID-19 virus, can be assessed by determining if
workers could be exposed (e.g., through close contact with patients,
co-workers, or members of the public; contact with contaminated
surfaces, objects, or waste) and if controls are present to mitigate
those risks (OSHA, 2005; OSHA, October 18, 2016). While a standard can
specify controls applicable to particular hazards, the hazard
assessment can help identify where controls are needed in specific
areas of a particular worksite.
The fourth core element of an effective workplace safety and health
program approach is hazard prevention and control, which involves teams
of managers, coordinators, and employees assessing if a hazard can be
eliminated (e.g., by working at home to eliminate potential virus
exposure in the workplace). When hazards cannot be eliminated, the
hazard prevention process considers which hazards can be controlled by
implementing work practices (e.g., regular cleaning, disinfecting,
physical distancing) or controls (e.g., physical barriers, improvements
to the ventilation system). Additionally, the process of hazard
prevention and control determines if PPE is required as part of a
multi-layered strategy to protect workers from infectious biological
agents (OSHA, 2005; OSHA, October 18, 2016). The controls may function
more effectively when implemented in the most targeted manner following
a hazard assessment and team-based evaluation.
The fifth core element of an effective safety and health program
approach is evaluation and improvement. Safety and health programs
require periodic evaluation to ensure they are implemented as intended
and continue to achieve the goal of preventing injury and illness. This
re-evaluation can reduce hazards, or result in improvements in controls
to help reduce hazards. Managers have the prime responsibility for
ensuring the effectiveness of the program but managers should work as a
team with coordinators and employees to continually monitor the
worksite to identify what is and is not working and make adjustments to
improve worker safety and health measures (OSHA, January 2012; OSHA,
October 18, 2016).
The sixth core element of an effective safety and health program
approach is communication and coordination between host employers,
contractors, and staffing agencies. Because the employees of one
employer may expose employees of a different employer to a hazard, this
communication is essential to protecting all employees. An effective
program ensures that before employees go to a host worksite, both the
host employer and staffing agencies communicate about hazards on the
worksite, procedures for controlling hazards, and how to resolve any
conflicts that could affect employee safety and health (e.g., who will
provide PPE). The exchange of information about each employer's plans
can help reduce exposures by identifying areas where one employer may
need to provide additional protections (barriers, timing of workshifts,
etc.) to its employees. Additionally, exchanging contact information
between employers can facilitate worker protection in case they need to
report hazards or illnesses that may occur (OSHA, October 18, 2016). In
order to reduce COVID-19 transmission in the workplace, it will be
particularly important for employers to have clear plans about how they
can quickly alert other employers if a worker at a multi-employer site
subsequently tests positive for COVID-19 and was in close contact with
workers of other employers.
The seventh core element of an effective safety and health program
is education and training. Education and training ensures that
employees, supervisors, and managers are able to recognize and control
hazards, allowing them to work more safely and contribute to the
development and implementation of the safety and health program (OSHA,
2005; OSHA, January 2012; OSHA, October 18, 2016). Later in this Need
for Specific Provisions section there is a detailed explanation about
the need for training as a separate control to minimize COVID-19
transmission.
The effectiveness of a safety and health program approach in
preventing injury and illnesses is recognized by a number of
authoritative bodies. In its Total Worker Health program, the National
Institute for Occupational Safety and Health (NIOSH) lists a number of
core elements that are consistent with OSHA's safety and health program
approaches, including demonstrating leadership commitment to safety and
health, eliminating or reducing safety and health hazards, and
promoting and supporting employee involvement (NIOSH, December 2016).
The International Organization for Standardization (ISO) developed
ISO 45001, a consensus standard to help organizations implement a
safety and health management system (ISO, 2018). ISO notes that key
potential benefits of the system include reduced workplace incidents,
establishment of a health and safety culture by encouraging active
involvement of employees in ensuring their health and safety,
reinforcement of leadership commitment to health and safety, and
improved ability to comply with regulatory requirements.
The American National Standards Institute (ANSI) and American
Society of Safety Professionals (ASSP) also developed a health and
safety management systems standard for the purpose of reducing hazards
and risk in a systematic manner, based on a team approach that includes
management commitment and employee involvement, with an emphasis on
continual improvement (ANSI/ASSP, 2019). ANSI/ASSP note the widespread
acceptance that safety and health management systems can improve
occupational safety and health performance. (Id.) They further
highlight OSHA reports of improved safety and health performance by
companies who implement programs that rely on management system
principles (e.g., the Voluntary Protection Program), and that major
professional safety and health organizations support management systems
as effective in improving safety and health. As further proof that
safety and health management systems are valuable, they note that many
large and small organizations within the U.S. and internationally are
implementing these systems.
Based on the best available evidence, OSHA concludes that a COVID-
19 plan that is modeled on the safety and health program principles
discussed above, implemented by a COVID-19 coordinator, influenced by
employee input, and continuously evaluated, is an effective tool to
ensure comprehensive identification and mitigation of COVID-19 hazards.
As a result, OSHA concludes that a COVID-19 plan will reduce the
incidence of COVID-19 in
the workplace by helping to ensure that all effective measures are
implemented as part of a multi-layered strategy to minimize employee
exposure to COVID-19.
References
American National Standards Institute (ANSI)/American Society of
Safety Professionals (ASSP). (2019). ANSI/ASSP Z10.0-2019.
Occupational Health and Safety Management Systems. (ANSI/ASSP,
2019).
International Organization for Standardization (ISO). (2018).
Occupational health and safety. ISO 45001. (ISO, 2018).
National Institute for Occupational Safety and Health (NIOSH).
(2016, December). Fundamentals of total worker health approaches:
essential elements for advancing worker safety, health, and well-
being. Publication no. 2017-112. https://www.cdc.gov/niosh/docs/2017-112/pdfs/2017_112.pdf. (NIOSH, December 2016).
Occupational Safety and Health Administration (OSHA). (2005). Small
Business Handbook. Small Business Safety and Health Management
Series. OSHA 2209 02R 2005. https://www.osha.gov/sites/default/files/publications/small-business.pdf. (OSHA, 2005).
Occupational Safety and Health Administration (OSHA). (2012,
January). Injury and Illness Prevention Programs. White Paper.
https://www.osha.gov/dsg/InjuryIllnessPreventionProgramsWhitePaper.html. (OSHA, January
2012).
Occupational Safety and Health Administration (OSHA). (2016, October
18). Recommended Practices for Safety and Health Programs. OSHA
3885. https://www.osha.gov/sites/default/files/publications/OSHA3885.pdf. (OSHA, October 18, 2016).
C. Patient Screening and Management
Limited contact with potentially infectious persons is a
cornerstone of COVID-19 pandemic management. For example, screening and
triage of everyone entering a healthcare setting is an essential means
of identifying those individuals who have symptoms that could indicate
infection with the SARS-CoV-2 virus (CDC, February 23, 2021). Persons
with such symptoms can then be triaged appropriately to minimize
exposure risk to employees. CDC guidance provides a number of
approaches for screening and triage, including screening at entry,
separate triage areas for patients desiring evaluation for COVID-19
concerns, and electronic pre-screening prior to arrival (CDC, February
23, 2021). Once identified, potentially infected individuals can then
be isolated for evaluation, testing, and treatment. Triage increases
the likelihood of implementation of the appropriate level of personal
protective equipment for employees and other protections required for
exposure to potentially infectious patients. Patient segregation in
healthcare settings also reduces nosocomial (healthcare-acquired)
infections for employees. Inpatients continue to require regular re-
evaluation for COVID-19 symptoms.\20\
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\20\ Limiting and monitoring points of entry to the setting will
also help limit contact with potentially infectious persons. For
further discussion, see the Need for Specific Provisions for
Physical Distancing.
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Symptoms-based screening is a standard component of infection
control. This approach was recommended during the 2003 SARS epidemic
(caused by SARS-CoV-1, a different strain of SARS) and is routinely
recommended for airborne infections such as M. tuberculosis and
measles, and as a general practice in infection control programs
(Siegel et al., 2007). Because SARS-CoV-2 can be transmitted by
individuals who are infected but do not have symptoms (asymptomatic and
presymptomatic transmission), symptom-based screening will not identify
all infectious individuals (Viswanathan et al., September 15, 2020).
However, persons with symptoms early in their SARS-CoV-2 infection are
among the most infectious (Cevik et al., November 19, 2020). Therefore,
symptom-based screening will identify some of the highest-risk
individuals for SARS-CoV-2 transmission and thereby reduce the risk to
workers.
References
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Cevik, M. et al., (2020, November). SARS-CoV-2, SARS-CoV, and MERS-
CoV viral load dynamics, duration of viral shedding, and
infectiousness: A systematic review and meta-analysis. Lancet
Microbe 2021; 2: e13-22. https://doi.org/10.1016/S2666-5247(20)30172-5. (Cevik et al., November 19, 2020).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(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).
Viswanathan, M. et al., (2020, September 15). Universal screening
for SARS-CoV-2 infection: A rapid review. Cochrane Database of
Systematic Reviews, Issue 9. Art. No.: CD013718. DOI: 10.1002/
14651858.CD013718. (Viswanathan et al., September 15, 2020).
D. Standard and Transmission-Based Precautions
Standard and Transmission-Based Precautions are well-accepted as
important to controlling disease transmission (HICPAC, December 27,
2018; CDC, January 7, 2016). It should be noted that during times of
significant transmission, such as during this pandemic, additional
protections are needed to supplement the basic level of recommended
precautions and practices in these guidelines. For instance, wearing at
least a facemask regardless of interaction with known or suspected
infectious patients is needed during the pandemic (CDC, February 23,
2021).
Standard Precautions refers to infection prevention practices,
implemented in healthcare settings, where the presence of an infectious
agent is assumed (i.e., without the suspicion or confirmation of
exposure). The use of Standard Precautions thus relies on the
assumption that all patients, patient samples, potentially contaminated
materials (e.g., patient laundry, medical waste), and human remains in
healthcare settings are potentially infected or colonized with an
infectious agent(s). For example, Standard Precautions would include
appropriate hand hygiene and use of personal protective equipment as
well as practices to ensure respiratory hygiene, sharps safety, safe
injection practices, and sterilization and disinfection of equipment
and surfaces (CDC, February 23, 2021).
Transmission-Based Precautions add an additional layer of
protection to Standard Precautions. Transmission-Based Precautions
refers to those good infection prevention practices, used in tandem
with Standard Precautions that are based on the way an infectious
agent(s) may be transmitted. These precautions are needed, for example,
when treating a patient where it is suspected or confirmed that the
patient may be infected or colonized with agents that are infectious
through specific routes of exposure (Siegel et al., 2007). For example,
handwashing and safe handling of sharps (needles, etc.) are routine
Standard Precautions. An infectious agent capable of airborne
transmission through aerosols would require patient care in an airborne
infection isolation room (AIIR), if available, under Transmission-Based
Precautions.
Even before a patient is treated, certain Transmission-Based
Precautions
can be critical to protecting healthcare workers. For example, one
typical precaution is that patients and visitors who enter a waiting
room before being seen or triaged must wear facemasks, or face
coverings, as a source control device to prevent them from spreading
airborne droplets near the employees. These source control devices may
also be critical to reducing the likelihood that COVID-19 is spread as
the patients are transported from the admission area to a treatment
area.
The critical need for implementing Standard and Transmission-Based
Precautions in healthcare settings is evident in the Healthcare
Infection Control Practices Advisory Committee's (HICPAC's) 2017 Core
Infection Prevention and Control Practices for Safe Healthcare Delivery
in All Settings.\21\ The core practices included in that document
include Standard and Transmission-Based Precautions, which, HICPAC
recommended, need to be implemented in all settings where healthcare is
delivered.
---------------------------------------------------------------------------
\21\ HICPAC is a federal advisory committee that provides
guidance to the CDC and the Secretary of the Department of Health
and Human Services (HHS) regarding the practice of infection
control. In March 2013, CDC charged HICPAC with a review of existing
CDC guidelines to identify all recommendations that warrant
inclusion as core practices. In response, a HICPAC workgroup was
formed that contained representatives from the following stakeholder
organizations: America's Essential Hospitals, the Association for
Professionals in Infection Control and Epidemiology (APIC), the
Council of State and Territorial Epidemiologists (CSTE), the Public
Health Agency of Canada (PHAC), the Society for Healthcare
Epidemiology of America (SHEA), and the Society of Hospital Medicine
(SHM) (HICPAC, March 15, 2017). This process resulted in HICPAC's
Core Infection Prevention and Control Practices for Safe Healthcare
Delivery in All Settings.
---------------------------------------------------------------------------
That Standard and Transmission-Based Precautions are a long-
standing and essential element of infection control in healthcare
industries is also evidenced by the CDC's 2007 Guideline for Isolation
Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings, which incorporate Standard and Transmission-Based Precautions
into their recommendations. This 2007 Guideline updated 1996
guidelines, which introduced the concept of Standard Precautions and
also noted the existence of infection control recommendations dating
back to 1970 (Siegel et al., 2007).
Both Standard and Transmission-Based Precautions are recommended by
the CDC for healthcare personnel during the COVID-19 pandemic (CDC,
February 23, 2021). The CDC considers healthcare personnel (HCP) to
include all paid and unpaid persons serving in healthcare settings who
have the potential for direct or indirect exposure to patients or
infectious materials, including body substances (e.g., blood, tissue,
and specific body fluids); contaminated medical supplies, devices, and
equipment; contaminated environmental surfaces; or contaminated air.
HCP include, but are not limited to, emergency medical service
personnel, nurses, nursing assistants, home healthcare personnel,
physicians, technicians, therapists, phlebotomists, pharmacists,
students and trainees, contractual staff not employed by the healthcare
facility, and persons not directly involved in patient care, but who
could be exposed to infectious agents that can be transmitted in the
healthcare setting (e.g., clerical, dietary, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel).
The CDC also has recommendations for protection of workers in
industries associated with healthcare. According to the CDC's Interim
Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic
(incorporated by reference, Sec. 1910.509), on-site management of
laundry, food service utensils, and medical waste should also be
performed in accordance with routine procedures (CDC, February 23,
2021).
The work of the College of American Pathologists (CAP) illustrates
the importance of taking core precautionary measures in healthcare
industries during the pandemic. CAP has provided recommendations for
staff protection during the COVID-19 pandemic. For example, CAP has
provided COVID-19-specific autopsy recommendations which include
biosafety considerations such as performing autopsies on COVID-19-
positive cases in an airborne infection isolation room (College of
American Pathologists, February 2, 2021).\22\
---------------------------------------------------------------------------
\22\ CAP is known for its peer-based Laboratory Accreditation
Program. The Centers for Medicare & Medicaid Services (CMS) allows a
CAP inspection in lieu of a CMS inspection. CAP inspections have a
similar status with a number of other leading healthcare and
biomedical laboratory authorities including the Joint Commission,
United Network for Organ Sharing, the National Marrow Donor Program,
the Foundation for the Accreditation of Cellular Therapies, and many
state agencies (College of American Pathologists, February 1,
2021b). CAP has worked with the CMS to implement virtual laboratory
inspections allowing labs to remain in compliance with Clinical
Laboratory Improvement Amendments regulations (College of American
Pathologists, February 1, 2021a).
---------------------------------------------------------------------------
The Standard and Transmission-Based Precautions required by the ETS
only extend to exposure to SARS-CoV-2 and COVID-19 protection. The
agency does not intend the ETS to apply to other workplace hazards.
References
Centers for Disease Control and Prevention (CDC). (2016, January 7).
Transmission-based precautions. https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html. (CDC,
January 7, 2016).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
College of American Pathologists. (2021, February 2). Amended COVID-
19 autopsy guideline statement from the CAP Autopsy Committee.
https://documents.cap.org/documents/COVID-Autopsy-Statement.pdf.
(College of American Pathologists, February 2, 2021).
Healthcare Infection Control Practices Advisory Committee (HICPAC).
(2018, December 27). Core infection prevention and control practices
for safe healthcare delivery in all settings. https://www.cdc.gov/hicpac/recommendations/core-practices.html. (HICPAC, December 27,
2018).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(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).
E. Personal Protective Equipment (PPE)
As previously discussed in Grave Danger (Section IV.A. of the
preamble), COVID-19 infections occur mainly through exposure to
respiratory droplets (referred to as droplet transmission) when a
person is in close contact with someone who has COVID-19. COVID-19 can
sometimes also be spread by airborne transmission (CDC, May 13, 2021).
As the CDC explains, when people with COVID-19 cough, sneeze, sing,
talk, or breathe, they produce respiratory droplets, which can travel a
limited distance--thereby potentially infecting people within close
physical proximity--before falling out of the air due to gravity.
Facemasks, face coverings, and face shields are all devices used for
their role in reducing the risk of droplet, and potentially airborne,
transmission of COVID-19 primarily at the source. Additional discussion
on the efficacy of each device, and the need for facemasks and face
shields specifically, is explained below. (Respirator use is also
included in the ETS and more information on the
need for respirators to prevent the spread of COVID-19 is discussed in
the Need for Specific Provisions for Respirators, further below.)
Well-fitting facemasks, not face coverings, are the baseline
requirement in healthcare settings because of their fluid resistant
qualities (discussed in detail below). However, the role of facemasks
and face coverings are otherwise similar in source control and personal
protection for the wearer. OSHA's position on the importance of face
coverings and facemasks is supported by a substantial body of evidence.
Consistent and correct use of face coverings and facemasks 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, April
19, 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 (and
facemasks) serve two purposes, to both protect healthy people from
acquiring COVID-19 and to prevent sick people from further spreading it
(WHO, December 1, 2020).
I. Need for Facemasks
Facemasks 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. The term ``facemask,'' as used in
this ETS, is defined as a surgical, medical procedure, dental, or
isolation mask that is FDA-cleared, FDA-authorized, or offered or
distributed as described in an FDA enforcement policy. These are most
commonly referred to as ``surgical masks'' or ``medical procedure
masks.'' As previously mentioned, facemasks reduce the risk of droplet
transmission through their dual function as both source control and
personal protection (OSHA, January 28, 2021; Siegel et al., 2007). In
healthcare settings, facemasks have long been recognized as an
important method of source control for preventing the spread of
infectious agents transmitted via respiratory droplets (e.g., in the
operating room to prevent provider saliva and respiratory secretions
from contaminating the surgical field and infecting patients). However,
facemasks do not filter out very small airborne particles and do not
provide complete protection even from larger particles because the mask
seal is not tight (FDA, December 7, 2020).
Facemasks are designed and regulated through various FDA processes
to protect the person wearing them. Not all devices that resemble
facemasks are FDA-cleared or authorized. To receive FDA clearance,
manufacturers are required to submit an FDA premarket notification
(also known as a 510(k) notification) for new products. Data in the
510(k) submission must show that the facemask is substantially
equivalent to a facemask already on the market in terms of safety and
effectiveness. Facemasks are tested for fluid resistance, filtration
efficiency (particulate filtration efficiency and bacterial filtration
efficiency), differential pressure, flammability and biocompatibility
(FDA, July 14, 2004).\23\
---------------------------------------------------------------------------
\23\ Medical devices are subject to premarket review through
risk-based classification under the Federal Food, Drug, and Cosmetic
Act. Premarket approval (PMA) applies to the highest-risk, Class III
devices, and 510(k) notification applies to most Class II and some
Class I devices. Under the 510(k) notification pathway, FDA
determines whether the device is substantially equivalent to a
lawfully marketed predicate device. Medical device manufacturers are
required to submit a 510(k) notification if they intend to introduce
a device into commercial distribution for the first time or
reintroduce a device that will be significantly changed or modified
to the extent that its safety or effectiveness could be affected.
Such change or modification could relate to the design, material,
chemical composition, energy source, manufacturing process, or
intended use. For more information, see https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device and https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances.
---------------------------------------------------------------------------
Research developed during the current SARS-CoV-2 pandemic provides
evidence of the protection afforded by facemasks. First, a universal
surgical masking requirement for all healthcare workers and patients
was implemented in Spring 2020 in the Mass General Brigham healthcare
system, which is the largest in Massachusetts (Wang et al., July 14,
2020). Based on daily infection rates among healthcare workers, the
authors found that universal masking was associated with a
significantly lower rate of SARS-CoV-2 positivity. Although the authors
noted that other interventions, such as restricting visitors, were also
put in place, they concluded that their results supported universal
masking as part of a multi-pronged infection reduction strategy in
healthcare settings.
Second, a systematic review and meta-analysis evaluated research on
healthcare workers exposed to SARS-CoV-2, as well as the SARS and
Middle East respiratory syndrome (MERS) viruses (Chu et al., June 27,
2020). Six studies compared the odds of infection in those who wore
surgical or similar facemasks compared to those who did not wear any
facemask; four of the six studies were on healthcare workers and all
six were from the 2003 SARS epidemic. Participants who wore surgical or
similar facemasks had only a third of the infection risk of those who
did not wear any facemask.
Third, a review of respiratory protection for healthcare workers
during pandemics noted that surgical mask material has been shown to
protect against more than 95% of viral aerosols under laboratory
conditions (Garcia-Godoy et al., May 5, 2020). The authors also
reviewed research showing that surgical masks reduced aerosolized
influenza exposure by an average of six-fold, depending on mask
design.\24\
---------------------------------------------------------------------------
\24\ For a discussion of the efficacy of respirators over
facemasks for protection against aerosolized particles, please see
the respirator discussion in the Need for Specific Provisions
section, below.
---------------------------------------------------------------------------
Finally, in one epidemiological study, a specialized team of
contact tracers at Duke University Health System in North Carolina
categorized recorded COVID-19 cases among their healthcare workers
(Seidelman et al., June 25, 2020). Of the cases that were categorized
as healthcare-acquired (meaning acquired as a result of either an
unmasked exposure for greater than 10 minutes at less than 6 feet to
another healthcare worker who was symptomatic and tested positive for
the virus, or an exposure to a COVID-19-positive patient while not
wearing all CDC-recommended PPE or while there was a breach in PPE),
70% were linked to an unmasked exposure to another healthcare worker.
Although cloth face coverings have gained widespread use outside of
healthcare settings during this pandemic, OSHA has determined that
cloth face coverings do not offer sufficient protection for covered
healthcare workers for multiple reasons. First, cloth face coverings,
as defined by the CDC, encompass such a wide variety of coverings that
there is no assurance
of any consistent protection to the wearer, and even source protection
can vary significantly depending on the construction and fit of the
face covering. Second, a number of studies suggest that, properly worn
over the nose and mouth, facemasks provide better protection than face
coverings, which is an important consideration in healthcare settings
where there are regular, known exposures to COVID-19-positive persons.
For example, one randomized trial of cloth face coverings compared
rates of clinical respiratory illness, influenza-like illness, and
laboratory-confirmed respiratory virus infections in 1,607 healthcare
workers in 14 hospitals in Vietnam (MacIntyre et al., March 26, 2015).
Infection risks were statistically higher in the cloth face covering
group compared to the facemask group: The risk of influenza-like
illness was 6.6 times higher, and the risk of laboratory-confirmed
respiratory virus infection was 1.7 times higher, in those who wore
cloth face coverings compared to those who wore facemasks. Another
study which reviewed respiratory protection for healthcare workers
during pandemics showed greater protection from surgical masks compared
to face coverings (Garcia-Godoy et al., May 5, 2020). Finally, 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, but that
facemasks and N95s provided better protection than cotton face
coverings. Specifically, the researchers found that when spaced roughly
20 inches apart, if both an infected and uninfected individual were
wearing a cotton face covering, the uninfected person reduced
inhalation of infectious virus by 67%. But if both individuals were
wearing facemasks, exposure was reduced by 76% and when an infected
individual was wearing an N95, exposure was reduced by 96%.
Third, cloth face coverings do not function as a barrier to protect
employees from hazards such as splashes or large droplets of blood or
bodily fluids, which is a common hazard in healthcare settings. And
finally, OSHA has previously established that medical facemasks are
essential PPE for many workers in healthcare, as enforced under both
the PPE standard (29 CFR 1910.132) and more specifically, the
Bloodborne Pathogens standard (29 CFR 1910.1030).
Given the health outcomes related to COVID-19 and the exposure
characteristics found in healthcare settings (e.g., splashes or large
droplets of blood or bodily fluids), OSHA has determined that cloth
face coverings are not appropriate for workers in these settings.
Research clearly indicates that facemasks provide essential protection
for workers in covered healthcare settings.
II. Need for Face Shields
The term ``face shield,'' as used in this ETS, is a device
typically made of clear plastic, that covers the wearer's eyes, nose,
and mouth, wraps around the sides of the wearer's face, and extends
below the wearer's chin. Face shields have long been recognized as
effective in preventing splashes, splatters, and sprays of bodily
fluids and have a role in preventing the primary route of droplet
transmission, although not aerosolized transmission. As explained
above, OSHA has determined based on the best available evidence that
facemask usage is a necessary protective measure to prevent the spread
of COVID-19 for any covered employee. However, the use of face shields,
a less protective barrier, is permitted to either supplement facemasks
where there is a particular risk of droplet exposure, or as an
alternative option in certain limited circumstances where facemask
usage is not feasible.
Face shields are proven to provide some protection to the wearer
from exposure to droplets, and OSHA has long considered face shields to
be PPE under the general PPE standard (29 CFR 1910.132) and the Eye and
Face Protection standard (29 CFR 1910.133) for protection of the face
and eyes from splashes and sprays. The potential protective value of
face shields against droplet transmission is supported by a 2014 study,
in which NIOSH investigated the effectiveness of face shields in
preventing the transmission of viral respiratory diseases. The purpose
of the study was to quantify exposure of cough aerosol droplets and
examine the efficacy of face shields in reducing this exposure.
Although face shields were not found to be effective against smaller
particles, which can remain airborne for extended periods and can
easily flow around a face shield to be inhaled, the face shields were
effective in blocking larger aerosol particles (median size of 8.5
[micro]M). Face shields worn over a respirator also reduced surface
contamination of the respirator by 97%. The study's final conclusion
was that face shields can be a useful complement to respiratory
protections; however, they cannot be used as a substitute for
respiratory protection, when needed (Lindsley et al., June 27, 2014). A
recent update of the Lindsley study (Lindsley et al., January 7, 2021)
found that face shields blocked only 2% of aerosol produced by
coughing. These findings suggest that face shields might be a relevant
form of protection in healthcare settings to protect employees from
droplet exposure when they could have close contact with individuals
who are potentially infected with COVID-19.
Face shields have proven less effective as a method of source
control or a method of personal protection than facemasks. For example,
in considering face shields' value as source control, Verma et al.,
(June 30, 2020) observed the effect of a face shield on respiratory
droplets produced by simulating coughs or sneezes with a manikin. The
face shield initially blocked the forward motion of the droplet stream,
but droplets were then able to flow around the shield and into the
surrounding area. The study authors concluded that face shields alone
may not be as effective in blocking droplets.
In another study, Stephenson et al., (February 12, 2021) evaluated
the effectiveness of face coverings, facemasks, and face shields in
reducing droplet transmission. Breathing was simulated in two manikin
heads (a transmitter and receiver) that were placed four feet apart.
Artificial saliva containing a marker simulating viral genetic material
was used to generate droplets from the transmitter head. The
researchers found that face coverings, facemasks, and face shields all
reduced the amount of surrogate genetic material measured in the
environment and the amount that reached the receiver manikin head at
four feet. While face shields reduced surrogate genetic material by
98.6% in the environment and 95.2% at the receiver, genetic material
was still deposited downward in the immediate area of the transmitter,
suggesting that use of face shields without a facemask could result in
a contamination of shared surfaces. This limits the effectiveness of
face shields alone as a method of source control for shared workspaces.
Additionally, face shields used as personal protective devices showed
that the face shields protected the wearer from large cough aerosols
directed at the face, but were much less effective against smaller
aerosols which were able to flow around the edges of the shield and be
inhaled (Lindsley et al., June 27, 2014).
Based on this evidence, OSHA has determined that face shields are
not
generally appropriate as a substitute for a facemask because they are
less effective at reducing the risk of droplet and potential airborne
transmission. However, face shields do offer some protection from
droplet transmission and are, accordingly, required by the ETS to be
used in any circumstance where, for example, an individual may not be
able to wear a facemask due to a medical condition or due to other
hazards (e.g., heat stress, arc flash fire hazards). In such limited
(and often temporary) situations, a face shield may be the most
effective measure to add a layer of protection to reduce workers'
overall COVID-19 transmission risk, particularly when combined with
other protective measures.
Additionally, OSHA recognizes that face shields can provide some
additional protection when used in addition to a facemask by protecting
the wearer's eyes and preventing their facemask from being contaminated
with respiratory droplets from other persons. This additional
protection may be particularly useful for employees who cannot avoid
close contact with others or are unable to work behind barriers.
Accordingly, the ETS allows employers to require face shields in
addition to facemasks where employment circumstances might warrant the
additional protection.
OSHA has always considered recognized consensus standards, with
design and construction specifications, when determining the PPE
requirements of the agency's standards, as required by the OSH Act (29
U.S.C. 655(b)(8)) and the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).
The agency has already incorporated by reference the ANSI/ISEA
Z87.1, Occupational and Educational Personal Eye and Face Protection
Devices consensus standard for face shields in its Eye and Face
Protection standard (29 CFR 1910.133). In this ETS the agency will
incorporate by reference more recent editions of the ANSI/ISEA standard
than are currently provided for in the existing standard. Additionally,
for the limited purpose of complying with the ETS, the agency will also
allow any face shield that meets the criteria outlined in the
definition of ``face shield'' found in the definition sections of the
ETS. That is: (1) Certified to the ANSI/ISEA Z87.1-2010, 2015, or 2020
standard; or (2) covers the wearer's eyes, nose, and mouth to protect
from splashes, sprays, and spatter of body fluids, wraps around the
sides of the wearer's face (i.e., temple-to-temple), and extends below
the wearer's chin. Any face shield that is worn for the purpose of
complying with any OSHA standard other than Subpart U must still meet
the requirements of 29 CFR 1910.133.
III. Need for Other Types of PPE
Gloves and gowns (overgarments) are the two most common types of
PPE used in healthcare settings. A major principle of Standard
Precautions is that all blood and body fluids, whether from a patient,
patient sample, or infectious material, may contain transmissible
infectious agents (Siegel et al., 2007). Therefore, gloves and gowns
(overgarments) are required for certain examinations and all
procedures. These include everything from venipuncture to removing
medical waste to intubation. Similarly, gowns or similar protective
clothing are necessary for any activities in which splashes or clothing
contamination is possible. This applies as part of Standard Precautions
as well as for care of patients on Contact Precautions where
unintentional contact with contaminated environmental surfaces must be
avoided (Siegel et al., 2007).
Eye protection in the form of goggles or face shields (as discussed
above) can be used with facemasks to protect mucous membranes (eyes,
nose, and mouth) in situations where, for example, sprays of blood or
body fluids are possible. CDC recommends that healthcare workers wear
eye protection during patient care encounters to ensure eyes are
protected from infectious bodily fluids (CDC, February 23, 2021).
IV. Conclusion
In closing, the best available experimental and epidemiological
data support consistent use of facemasks in healthcare work settings to
reduce the spread of COVID-19 through droplet transmission. Adopting
facemask policies is necessary, as part of a multi-layered strategy
combined with other non-pharmaceutical interventions such as physical
distancing, hand hygiene, and adequate ventilation, to protect
employees from COVID-19. Based on the proven effectiveness of facemask
use and the effectiveness of face shields in preventing contamination
of facemasks and protecting the eyes when there is a particular risk of
droplet exposure, OSHA's COVID-19 ETS includes necessary provisions for
required use of facemasks and face shields (e.g., either as a
complementary device or in such circumstances where it is not
appropriate or possible to wear a facemask). The ETS also requires
additional PPE, such as gloves, gowns, and eye protection, in certain
limited circumstances where there is likely exposure to persons with
COVID-19.
References
Centers for Disease Control and Prevention (CDC). (2021, February
2). Order under Section 361 of the Public Health Service Act (42
U.S.C. 264) and 42 Code of Federal Regulations 70.2, 71.31(b),
71.32(b). Federal Register notice: wearing of face masks while on
conveyances and at transportation hubs. https://www.cdc.gov/quarantine/masks/mask-travel-guidance.html. (CDC, February 2, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 19).
Guidance for Wearing Masks. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html. (CDC,
April 19, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks,
and Eye Protection to Prevent Person-to-Person Transmission of SARS-
CoV-2 and COVID-19: a systematic review and meta-analysis. The
Lancet 395: 1973-1987. https://doi.org/10.1016/. (Chu et al., June
27, 2020).
Food and Drug Administration (FDA). (2004, July 14). Guidance for
industry and FDA staff. Surgical masks--premarket notification
[510(k)] submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions. (FDA, July 14, 2004).
Food and Drug Administration (FDA). (2020, December 7). N95
respirators, surgical masks, and face masks. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks#s2. (FDA, December 7,
2020).
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(Garcia-Godoy et al., May 5, 2020).
Lindsley, W. et al., (2014, June 27). Efficacy of face shields
against cough aerosol droplets from a cough simulator. Journal of
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10.1080/15459624.2013.877591. (Lindsley et al., June 27, 2014).
Lindsley, W. et al., (2021, January 7). Efficacy of face masks, neck
gaiters and face shields for reducing the expulsion of simulated
cough-generated aerosols. Aerosol Science and Technology, DOI:
10.1080/02786826.2020.1862409. (Lindsley et al., January 7, 2021).
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(MacIntyre et al., March 26, 2015).
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28). Frequently asked questions COVID-19. https://www.osha.gov/coronavirus/faqs. (OSHA, January 28, 2021).
Seidelman, J. et al., (2020, June 25). Universal masking is an
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December 1, 2020).
F. Respirators
I. Respirator Use in Healthcare
As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 might spread through airborne transmission
during aerosol-generating procedures (AGPs) such as intubation.
Moreover, outside of AGP scenarios, CDC has noted growing evidence that
airborne droplets and particles can remain suspended in air, travel
distances beyond 6 feet, and be breathed in by others (CDC, May 13,
2021). Grave Danger (Section IV.A. of the preamble) notes studies
showing that infectious viral particles have been collected at
distances as far as 4.8 meters away from a COVID-19 patient (Lednicky
et al., September 11, 2020), and airborne COVID-19 infection has been
identified in a Massachusetts hospital (Klompas et al., February 9,
2021). Accordingly, the CDC recommends the use of airborne Transmission
Precautions, including the use of respirators, for any healthcare
workers caring for patients with suspected or confirmed COVID-19 (CDC,
March 12, 2020). This airborne transmission risk is in addition to the
risks associated with contact and droplet transmission. Respirators
have long been recognized as an effective and mandatory means of
controlling airborne transmissible diseases and the use of this
personal protective equipment is regulated under OSHA's Respiratory
Protection standard (29 CFR 1910.134).
The CDC has issued core guidelines for when ``healthcare
personnel'' should use respiratory protection against COVID-19
infection (see Interim Infection Prevention and Control Recommendations
for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic (CDC, February 23, 2021)). These recommendations have been
based on the most currently available information about COVID-19, such
as how the virus spreads, and are applicable to all healthcare settings
in the U.S. In the guidance, the CDC defines ``healthcare settings'' as
places where healthcare is delivered, including but not limited to:
acute care facilities, long-term acute care facilities, inpatient
rehabilitation facilities, nursing homes, assisted living facilities,
home healthcare, vehicles where healthcare is delivered (e.g., mobile
clinics), and outpatient facilities (e.g., dialysis centers, physician
offices). In addition, the CDC provides examples of ``healthcare
personnel,'' which include emergency medical service personnel, nurses,
nursing assistants, home healthcare personnel, physicians, technicians,
therapists, phlebotomists, pharmacists, students and trainees,
contractual staff not employed by the healthcare facility, and persons
not directly involved in patient care, but who could be exposed to
infectious agents that can be transmitted in the healthcare setting
(e.g., clerical, dietary, environmental services, laundry, security,
engineering and facilities management, administrative, billing, and
volunteer personnel).
The CDC describes who is at greatest risk for COVID-19 infection in
a set of FAQs designed for healthcare workers (CDC, March 4, 2021). In
the FAQs, the CDC notes that those currently at greatest risk of COVID-
19 infection are persons who have had prolonged, unprotected close
contact (i.e., within 6 feet for a combined total of 15 minutes or
longer in a 24 hour period) with a patient with confirmed COVID-19,
regardless of whether the patient has symptoms. Moreover, according to
the CDC, persons frequently in congregate healthcare settings (e.g.,
nursing homes, assisted living facilities) are at increased risk of
acquiring infection because of the increased likelihood of close
contact. In the FAQs, the CDC also reports that current data suggest
that close-range aerosol transmission by droplet and inhalation, and
contact followed by self-delivery to the eyes, nose, or mouth are
likely routes of transmission for COVID-19, and that long-range aerosol
transmission, has not been a feature of the virus. The CDC further
explains that potential routes of close-range transmission include
splashes and sprays of infectious material onto mucous membranes and
inhalation of infectious virions (i.e., the active, infectious form of
a virus) exhaled by an infected person, but that the relative
contribution of each of these is not known for COVID-19.
As the CDC states in the FAQs (CDC, March 4, 2021), although
facemasks are routinely used for the care of patients with common viral
respiratory infections, N95 filtering facepiece respirators or
equivalent (e.g., elastomeric half-mask respirators) or higher-level
(e.g., full facepiece respirators or PAPRs) respirators are routinely
recommended to protect healthcare workers from emerging pathogens like
the virus that causes COVID-19, which have the potential for
transmission via small particles. The CDC further advises that while
facemasks will provide barrier protection against droplet sprays
contacting mucous membranes of the nose and mouth, they are not
designed to protect wearers from inhaling small particles. Because of
this, the CDC recommends the use of respirators for close-contact care
of patients with suspected or confirmed COVID-19. The CDC recommends
that N95 filtering facepiece respirators (FFRs) and higher-level
respirators, such as other disposable FFRs, powered air-purifying
respirators (PAPRs), and elastomeric respirators, should be used when
both barrier and respiratory protection is
needed for healthcare workers because respirators provide better fit
and filtration characteristics.
The CDC recommendations in Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic are divided into two separate categories.
These include: (1) Recommended infection prevention and control
practices when caring for a patient with suspected or confirmed COVID-
19; and (2) recommended routine infection prevention and control
practices during the COVID-19 pandemic (CDC, February 23, 2021).
A topic of interest related to the selection and use of respirators
is their dual role as both personal protective equipment for the wearer
and also source control to reduce the potential for transmission of
potentially infectious exhaled air to others. While many filtering
facepiece respirators do not have an exhalation valve, other filtering
facepiece respirators do. The other ``higher-level'' respirators
referenced above, and in CDC guidance (e.g., half or full facepiece
elastomeric respirators and PAPRs), do have exhalation valves. An
exhalation valve is a portal in the respirator to allow unfiltered air
to leave the respirator in order to reduce breathing resistance for the
wearer and reduce moisture and heat buildup inside the respirator.
While the exhalation valve does allow some particles to escape through
the valve, it is important to compare the performance of a respirator
with an exhalation valve to other acceptable forms of source control in
order to determine if there are actually reduced levels of
effectiveness. NIOSH studied this issue and released a technical report
entitled ``Filtering Facepiece Respirators with an Exhalation Valve:
Measurements of Filtration Efficiency to Evaluate Their Potential for
Source Control'' (NIOSH, December 2020). In the report, NIOSH concluded
that respirators with exhalation valves were equally effective as
facemasks:
this study found that unmitigated FFRs with an exhalation valve that
were tested in an outward position (with particles traveling in the
direction of exhalation) have a wide range of penetration, emitting
between <1% and 55%. Further testing could measure greater particle
penetration. Even without mitigation, FFRs with exhalation valves
can reduce 0.35-[micro]m MMAD particle emissions more consistently
than surgical masks, procedure masks, cloth face coverings, or
fabric from cotton t-shirts; . . . FFRs with an exhalation valve
provide respiratory protection to the wearer, and this study
demonstrates that they can also reduce 0.35-[micro]m MMAD particle
emissions to levels similar to or better than those provided by
surgical masks and unregulated barrier face coverings.
The results that NIOSH observed can be explained in two ways.
First, the majority of the leakage takes place around the seal by the
nose and mouth, and respirators are designed to provide tight seals
around the face so that there is only minimal leakage. Facemasks, on
the other hand, do not typically seal tightly to the face and thus
significant quantities of unfiltered air with small particles will also
escape through the gaps on the side and at the nose, as well as
potentially through the fabric of less protective filter materials.
Second, the level of filtration in facemasks is highly variable, so a
wide range of filter efficiencies have been acceptable under CDC
guidance. The CDC does not recommend that respirators with exhaust
valves be used as source controls, but the CDC's last updated
recommendation on this subject was published in August of 2020, four
months before the NIOSH study, and cited lack of data as the basis for
the warning against relying on such respirators (CDC, April 9, 2021b).
Therefore, the NIOSH study with its conclusion that respirators with
exhaust valves are not less adequate as source controls than other
acceptable source controls, appears to represent the best available
evidence. OSHA therefore concludes that at this time there is no basis
for OSHA to prohibit any NIOSH-approved filtering facepiece respirator
from serving as both personal protective equipment and as source
control. The NIOSH report also details methods of covering the
filtering facepiece respirator's exhalation valve in various manners to
further improve the effectiveness as source control, which OSHA
considers a recommended practice, but not strictly necessary. There are
also other methods that can be used to cover or filter the exhalation
valve of elastomeric respirators (e.g., place a medical mask over the
respirator).
II. The CDC's Recommended Infection Prevention and Control Practices
When Caring for a Patient With Suspected or Confirmed COVID-19
The CDC recommends that healthcare personnel (including workers
that perform healthcare services and those that perform healthcare
support services) who enter the room or area of a patient with
suspected or confirmed COVID-19 adhere to Standard Precautions plus
gown, gloves, and eye protection, and also use a NIOSH-approved N95
filtering facepiece or equivalent or higher-level respirator. The CDC
notes in a set of FAQs that its recommendation to use NIOSH-approved
N95 disposable filtering facepiece or higher-level respirators when
providing care for patients with suspected or known COVID-19 is based
on the current understanding of the COVID-19 virus and related
respiratory viruses (CDC, March 10, 2021).
As noted above, the CDC recommendations listed in Interim Infection
Prevention and Control Recommendations for Healthcare Personnel During
the Coronavirus Disease 2019 (COVID-19) Pandemic are applicable to all
U.S. settings where healthcare is delivered. To this end, the
recommendations on respirator use are repeated in a variety of
additional CDC guidelines for specific categories of healthcare
settings (e.g., nursing homes, dental settings, assisted living
facilities, home health care settings). For example, in its guidance
for nursing homes, the CDC recommends that residents with known or
suspected COVID-19 be cared for while using all recommended PPE,
including an N95 or higher-level respirator (CDC, March 29, 2021). In
addition, in its guidance for dental settings, the CDC recommends that
dental healthcare personnel who enter the room of a patient with
suspected or confirmed COVID-19 use a NIOSH-approved N95 or equivalent
or higher-level respirator, as well as other PPE (CDC, December 4,
2020). Additionally, in its guidance for assisted living facilities,
the CDC recommends an N95 or higher-level respirator for personnel for
situations where close contact with any (symptomatic or asymptomatic)
resident cannot be avoided, if COVID-19 is suspected or confirmed in a
resident of the assisted living facility (i.e., resident reports fever
or symptoms consistent with COVID-19) (CDC, May 29, 2020). Also, in its
guidance for home healthcare settings, the CDC recommends that when
home health agency personnel are involved in the care of people with
confirmed or suspected COVID-19 at their homes, the personnel adhere to
relevant infection prevention and control practices as described in the
core healthcare guidance Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic (i.e., that they use N95 or higher-level
respirators) (CDC, October 16, 2020).
In addition to its infection prevention and control guidelines for
healthcare personnel in healthcare settings, the CDC has issued
infection prevention and control guidelines for conducting postmortem
procedures on decedents/
human remains during the COVID-19 pandemic in Collection and Submission
of Postmortem Specimens from Deceased Persons with Confirmed or
Suspected COVID-19 (CDC, December 2, 2020). In this guidance, the CDC
recommends respirators while conducting autopsies on decedents in all
cases due to the likelihood of aerosol generation during the
performance of autopsies (CDC, December 2, 2020). The WHO has also
issued guidelines for COVID-19 infection control for aerosol-generating
procedures during autopsies. For example, WHO recommends respirators
for procedures such as the use of power saws (WHO, September 4, 2020).
As supported by the above evidence and guidance from authoritative
bodies, OSHA has concluded that healthcare employees have a heightened
risk of COVID-19 infection when working with patients with known or
suspected COVID-19. Accordingly, in any healthcare setting where
employees are exposed to patients with known or suspected COVID-19,
whether or not AGPs are performed, employers are required to provide
N95s or higher-level respirators and follow all requirements under 29
CFR 1910.134, including medical evaluations and fit testing.
III. Applicability of the Respiratory Protection Standard to COVID-19
OSHA's Respiratory Protection standard (29 CFR 1910.134) has
general requirements for respiratory protection for workers exposed to
respiratory hazards, including the COVID-19 virus. In the context of
the pandemic, the agency has applied the Respiratory Protection
standard to situations in healthcare settings where workers are exposed
to suspected or confirmed sources of COVID-19. OSHA's Respiratory
Protection standard has been in effect since 1998 and the purpose of
those controls have been established for decades (63 FR 1152, January
8, 1998). The standard contains requirements for the administration of
a respiratory protection program, with worksite-specific procedures,
respirator selection, employee training, fit testing, medical
evaluation, respirator use, respirator cleaning, maintenance, and
repair, among other requirements. It is important to note that the
standard applies to ``biological hazards'' (63 FR 1180, January 8,
1998). Accordingly, the agency will continue to apply the Respiratory
Protection standard to work tasks and situations in healthcare as
covered by 29 CFR 1910.502.
IV. Respirator Provisions Tailored to the COVID-19 Pandemic Will
Clarify Employer Responsibilities
Notwithstanding the applicability of the Respiratory Protection
standard, as OSHA will explain in this discussion, it is imperative
that the ETS contain additional provisions related to the employer's
discretion to select respirators beyond what is required by 29 CFR
1910.134. These additional requirements are necessary in order to
appropriately protect workers in healthcare industries. In the Need for
the ETS (Section IV.B. of the preamble), OSHA has addressed why
existing standards in general are inadequate to address the COVID-19
hazard. In this discussion the agency focuses more specifically on how
clarifications regarding respirator need and use will help address
COVID-19 hazards.
Many employers are confused as to when respiratory protection is
required for protection against COVID-19, leaving many unprotected
healthcare workers at high risk of becoming infected with COVID-19.
This confusion has been exacerbated by two factors. First, many
employers that need to provide respirators to protect their workers
from COVID-19 have never needed to provide respirators to their workers
in the past (e.g., many employers in the home health care or nursing
home sector), or have not had to routinely provide respirators to
certain workers in their facilities to protect them against infectious
disease hazards (e.g., the housekeeping or facilities maintenance staff
in some medical facilities). Second, there have been respirator and fit
testing supply shortages and a widespread misinterpretation by
employers of OSHA's temporary enforcement memoranda on respiratory
protection. One issue of great concern to the agency is a
misunderstanding by employers about crisis capacity strategies, which
were initially suggested by the CDC as a means to optimize supplies of
disposable N95 FFRs in healthcare settings when the alternative would
be no respiratory protection at all. Many workers report that their
employers have employed crisis capacity strategies as the de facto
daily practice, even when additional respirators were available for
use. To address these issues, the ETS contains clear mandates on when
respiratory protection is required for protection against COVID-19 and
contains a note encouraging employers to use elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
To address initial N95 FFR shortages, the CDC began to create and
issue a series of strategies to optimize supplies of disposable N95
FFRs in healthcare settings when there is limited supply (CDC, April 9,
2021a). The strategies are based on the three general strata that have
been used to describe surge capacity to prioritize measures to conserve
N95 FFR supplies along the continuum of care (Hick et al., June 1,
2009). Contingency measures (temporary measures during expected N95
shortages), and then crisis capacity measures (emergency strategies
during known shortages that are not commensurate with U.S. standards of
care), augment conventional capacity measures and are meant to be
considered and implemented sequentially. However, as the supply of
respirators for healthcare personnel has increased, the CDC and FDA
have encouraged employers to transition away from the most extreme
measures of respirator conservation, crisis and contingency capacity
strategies, to conventional use (FDA, April 9, 2021; CDC, April 9,
2021a). The use of crisis capacity strategies is likely to increase the
risk of COVID-19 exposure when compared to conventional and contingency
capacity strategies.
The CDC's conventional capacity strategies for optimizing the
supply of N95 FFRs, which the CDC recommends be incorporated into
everyday practices, include a variety of measures, such as training on
use and indications for the use of respirators, just-in-time fit
testing, limiting respirators during training, qualitative fit testing,
and the use of alternatives to FFRs. CDC's conventional capacity
strategy recommendation is to use NIOSH-approved alternatives to N95
FFRs where feasible. These include other classes of disposable FFRs,
reusable elastomeric half-mask and full facepiece air-purifying
respirators, and reusable powered air-purifying respirators (PAPRs).
All of these alternatives provide equivalent or higher-level protection
than N95 FFRs when properly worn. To assist employers in this effort,
NIOSH maintains a searchable, online Certified Equipment List
identifying all NIOSH-approved respirators (NIOSH, n.d., retrieved on
January 11, 2021). Since they are reusable, elastomeric respirators and
PAPRs have the added advantage of being able to be disinfected,
cleaned, and reused according to manufacturers' instructions. As such,
they can be used by workers after the COVID-19 pandemic and during
future pandemics that may again create N95 FFR
shortages. Consistent with this, the ETS provides in a note that, where
possible, employers are encouraged to select elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
Also consistent with this, the ETS provides in the same note that,
when there is a limited supply of filtering facepiece respirators (and
only when there is a limited supply of filtering facepiece
respirators), employers may follow the CDC's Strategies for Optimizing
the Supply of N95 Respirators (April 9, 2021a). This may include the
use of respirators beyond the manufacturer-designated shelf life for
healthcare delivery; use of respirators approved under standards used
in other countries that are similar to NIOSH-approved N95 respirators;
limited re-use of N95 FFRs; and prioritizing the use of N95 respirators
and facemasks by activity type. However, again, the FDA and CDC are
recommending healthcare personnel and facilities transition away from
crisis capacity conservation strategies, such as decontaminating or
bioburden reducing disposable respirators for reuse, due to the
increased domestic supply of new respirators. The FDA and CDC believe
there is an increased supply of respirators to transition away from
these strategies (FDA, April 9, 2021; CDC, April 9, 2021a).
OSHA notes finally that its enforcement of the Respiratory
Protection standard has been complicated by the respirator and fit-
testing supply shortages incurred during the pandemic. In response to
these shortages, the agency issued numerous temporary enforcement
guidance memoranda allowing its Compliance Safety and Health Officers
(CSHOs) to exercise enforcement discretion when considering issuing
citations under the Respiratory Protection standard and/or the
equivalent respiratory protection provisions of other health standards
during the pandemic (OSHA, n.d., Retrieved December 22, 2020). OSHA's
temporary enforcement memoranda are aligned with CDC's Strategies for
Optimizing the Supply of N95 Respirators, which recommend a variety of
conventional, contingency, and crisis capacity control strategies, as
mentioned above (CDC, April 9, 2021a). Unfortunately, these memoranda
have been widely misinterpreted by employers, resulting in additional
confusion about OSHA's respiratory protection requirements during the
pandemic. OSHA bases this conclusion on staff expertise and experience,
as well as on reporting in news media articles (Safety + Health, April
9, 2020; Bailey and Martin, March 19, 2020). (See also Need for the ETS
(Section IV.B. of the preamble).) For example, employers have
misinterpreted the temporary enforcement guidance memoranda as offering
blanket waivers or exemptions for complying with certain provisions of
the Respiratory Protection standard (e.g., annual fit-testing
requirements). In addition, many employers did not understand that
these memoranda allow for enforcement discretion by CSHOs only in
circumstances where an employer can demonstrate that it made
unsuccessful but objectively reasonable efforts to obtain and conserve
supplies of FFRs and fit-testing supplies. While the memoranda were
intended as guidelines for CSHOs, employer misinterpretation of these
memoranda has resulted in fewer protections for workers, particularly
in healthcare industries.
OSHA is therefore clarifying that respirators are required for the
protection of workers exposed to suspected or confirmed sources of
COVID-19 in healthcare settings, and in all of those cases the
respirators must be used in accordance with the Respiratory Protection
standard (29 CFR 1910.134). OSHA also encourages employers, where
possible, to select elastomeric respirators or PAPRs instead of
filtering facepiece respirators to prevent shortages and supply chain
disruption. Because the crisis capacity strategy is less protective,
the employer should only use crisis capacity strategies for a limited
period of time and take immediate steps to purchase and use elastomeric
respirators or PAPRs in order to prevent future shortages and further
expose their workers to the grave danger of COVID-19.
V. Conclusion
The best available evidence demonstrates that respirator use is an
important means of reducing the likelihood of COVID-19 infection of the
wearer when used in accordance with Sec. 1910.134. Respirators are
necessary controls that provide some protection to healthcare workers
and healthcare support service workers when exposed to persons with
known or suspected COVID-19.
Based on the above analysis, the agency concludes that it is
necessary to add into the ETS respiratory protection requirements
tailored specifically to the COVID-19 pandemic. These requirements will
assist employers in identifying when respiratory protection is required
for healthcare workers and will help address and strengthen worker
protection during the pandemic. To this end, the ETS takes a
prioritization approach to the conservation of respirators by requiring
the use of respirators only where airborne transmission is the most
likely (when employees are exposed to persons with suspected or
confirmed COVID-19, or in accordance with Standard and Transmission-
Based Precautions in healthcare settings).
The increased certainty associated with the respirator requirements
in the healthcare section and added flexibility of allowing employers
to follow 29 CFR 1910.504 in some limited circumstances will lead to
more compliance, and more compliance will lead to improved protection
of workers. In addition, a note in the ETS will better inform employers
that they can consider selecting from other NIOSH-approved respirator
options (i.e., elastomeric respirators and PAPRs) as alternatives to
N95 FFRs for protection against COVID-19, as well as other respiratory
infections (e.g., tuberculosis, varicella, etc.) both during the
pandemic and beyond. Knowledge of alternative respiratory protection
options for healthcare employers to consider will help them choose
appropriate alternative respirators and help mitigate respirator supply
shortages.
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Interim Infection Prevention and Control Recommendations to Prevent
SARS-CoV-2 Spread in Nursing Homes. https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html. (CDC, March 29, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, April 9).
Strategies for optimizing the supply of N95 respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, April 9).
Personal Protective Equipment: Questions and Answers. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html. (CDC,
April 9, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Food and Drug Administration (FDA). (2021, April 9). FDA Recommends
Transition from Use of Decontaminated Disposable Respirators--Letter
to Health Care Personnel and Facilities. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and. (FDA, April 9, 2021).
Hick, J. et al., (2009, June 1). Refining surge capacity:
Conventional, contingency, and crisis capacity. Disaster Medicine
and Public Health Preparedness, 3(2 Suppl), S59-S67. https://doi.org/10.1097/DMP.0b013e31819f1ae2. (Hick et al., June 1, 2009).
Klompas, M. et al., (2021). A SARS-CoV-2 cluster in an acute care
hospital. Annals of Internal Medicine. [Epub ahead of print 9
February 2021] https://doi.org/10.7326/M20-7567. (Klompas et al.,
February 9, 2021).
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air of a hospital room with COVID-19 patients. International Journal
of Infectious Diseases, 100, 476-482. doi: 10.1016/
j.ijid.2020.09.025. (Lednicky et al., September 11, 2020).
National Institute for Occupational Safety and Health (NIOSH) (2020,
December). Filtering facepiece respirators with an exhalation valve:
Measurements of filtration efficiency to evaluate their potential
for source control. By Portnoff, L., Schall, J., Brannen, J., Suhon,
N., Strickland, K., Meyers, J. DHHS (NIOSH) Publication No. 2021-
107. https://www.cdc.gov/niosh/docs/2021-107/pdfs/2021-107.pdf?id=10.26616/NIOSHPUB2021107. Retrieved January 10, 2021.
(NIOSH, December, 2020).
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(n.d.) Certified equipment lists. Retrieved January 11, 2021 from
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(NIOSH, n.d., Retrieved January 11, 2021).
Occupational Safety and Health Administration (OSHA). (n.d.). COVID-
19--regulations--enforcement memoranda. Retrieved December 22, 2020
from https://www.osha.gov/coronavirus/standards#temp_enforcement_guidance. (OSHA, n.d., Retrieved December
22, 2020).
Safety + Health. (2020, April 9). OSHA allowing all employers to
suspend annual respirator fit testing. https://www.safetyandhealthmagazine.com/articles/19685-osha-allowing-all-employers-to-suspend-annual-respirator-fit-testing. (Safety +
Health, April 9, 2020).
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prevention and control for the safe management of a dead body in the
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2020).
G. Mini Respiratory Protection Program
I. Introduction
OSHA emphasizes that when respirators are required under the ETS to
protect employees against exposure to suspected or confirmed sources of
COVID-19, they must be used in accordance with the Respiratory
Protection standard (29 CFR 1910.134). Moreover, nothing in the ETS
changes an employer's obligation to identify hazards or provide a
respirator that must be used in accordance with the Respiratory
Protection standard for any other workplace hazard that might require
respiratory protection (e.g., silica, asbestos, airborne infectious
agents such as Mycobacterium tuberculosis).
OSHA's Respiratory Protection standard requires employers to
develop and implement a comprehensive written respiratory protection
program, required worksite-specific procedures and elements that
include, but are not limited to, respirator selection and use, medical
evaluation, fit testing, respirator maintenance and care, and training.
Establishing such a program can take time to establish and require a
level of expertise that some employers do not have, particularly if
they are a covered healthcare employer that did not typically have
respiratory hazards before COVID-19 (e.g., many employers in the home
health care or nursing home sector). In such cases, these regulatory
requirements may have unintentionally prevented employers from
providing their employees with a higher level of respiratory protection
than afforded by a facemask in circumstances where it may have been
beneficial to do so.
The ``mini respiratory protection program'' section of the ETS (29
CFR 1910.504) is designed to strengthen employee protections with a
small set of provisions for the safe use of respirators designed to be
easier and faster to implement than the more comprehensive respiratory
protection program. The ETS is addressing an emergency health crisis,
so it is critical for employers to be able to get more employee
protection in place quickly. OSHA expects that this approach will
facilitate additional employee choice for the additional protection
provided by respirators while reducing disincentives that may have
discouraged employers from allowing or voluntarily providing
respirators. A mini respirator program is therefore an important
control to protect employees from the hazard posed by COVID-19.
The mini respiratory protection program section is primarily
intended to be used for addressing circumstances where employees are
not exposed to suspected or confirmed sources of COVID-19, but where
respirator use could offer enhanced protection to employees. Examples
include when a respirator could offer enhanced protection in
circumstances where a less protective (in terms of filtering and fit)
facemask is required under the ETS. (See 29 CFR 1910.502(f)(4).) The
decision to use a respirator in place of a facemask could be due to the
higher filter efficiency and better sealing characteristics of
respirators when compared to facemasks and/or in consideration of an
employer's determination during their hazard assessment of constraints
on their
ability to implement other ETS provisions (e.g., physical distancing
and barriers).
If an employee uses a respirator in place of a facemask, then the
employer must ensure that the respirator is used in accordance with the
mini respiratory protection program section of the ETS or in accordance
with the Respiratory Protection standard. For example, if an employee
that is required to wear a facemask instead chooses to wear a
respirator when performing an aerosol-generating procedure (AGP) on a
patient who is not suspected or confirmed with COVID-19, the ETS only
requires the employer to ensure that the respirator is used in
accordance with the mini respiratory protection program section, rather
than in accordance with the Respiratory Protection standard, because
there is no exposure to a suspected or confirmed source of COVID-19
(see 29 CFR 1901.502(f)(4)(ii)). In contrast, employees performing AGPs
on patients with suspected or confirmed COVID-19 must be provided with
respirators that are used in accordance with the Respiratory Protection
standard (see 29 CFR 1901.502(f)(3)(i)). Additionally, employers will
still be obligated to provide a respirator that is used in accordance
with the Respiratory Protection standard for any AGPs performed on
patients suspected or confirmed with an airborne disease, such as
tuberculosis or measles.
II. Experience From the Respiratory Protection Standard (29 CFR
1910.134)
In determining the need for a mini respiratory protection program
section, the agency considered its experience with the existing
Respiratory Protection standard. While the majority of the Respiratory
Protection standard pertains to the use of respirators that are
required for the protection of employees against airborne hazards,
there is one provision allowing, but not requiring, employers to permit
employees to wear respirators in situations where respirators are not
required for protection against airborne hazards. (See 29 CFR
1910.134(c)(2).) In establishing the requirements of this provision of
the Respiratory Protection standard, OSHA also establishes some general
concepts to guide respirator use. These concepts include: (1) That the
respirator use will not in itself create a hazard; (2) that the
employer provides the respirator user with information about the safe
use and limitations of respirators; and (3) that the respirator is
cleaned, stored, and maintained so that its use does not present a
health hazard to the user. (29 CFR 1910.134(c)(2)(i) and (ii)).
OSHA has historically imposed a different set of requirements on
employers for when respirators are required to protect employees from
airborne hazards as compared to when they are not required for
protection against airborne hazards but are instead used voluntarily by
employees. More specifically, paragraph (c)(1) of the Respiratory
Protection standard requires employers to develop and implement a
comprehensive written respiratory protection program with required
worksite-specific procedures and elements whenever respirator use is
required by the standard. As noted earlier, these elements include, but
are not limited to, respirator selection and use, medical evaluation,
fit testing, respirator maintenance and care, and training. In
contrast, paragraph (c)(2) of the Respiratory Protection standard
requires employers to implement only a subset of these elements for the
voluntary use of respirators, greatly reducing the obligations of
employers who allow their employees to use respirators when such use is
not required for employee protection. In the 1998 rulemaking, OSHA
determined that paragraph (c)(2) is necessary because the use of
respirators may itself present a health hazard to employees who are not
medically able to wear them, who do not have adequate information to
use and care for respirators properly, and who do not understand the
limitations of respirators. Paragraph (c)(2) is intended to allow
employers flexibility to permit employees to use respirators in
situations where the employees wish to do so, without imposing the
burden of implementing an entire respirator program. At the same time,
it will help ensure that such use does not create an additional hazard
and that employees are provided with enough information to use and care
for their respirators properly (63 FR 1190, January 8, 1998).
The vast majority of voluntary respirator use situations under the
Respiratory Protection standard have historically involved the use of
FFRs, worn merely for an employee's comfort (63 FR 1190, January 8,
1998). Examples include employees who have seasonal allergies
requesting a FFR for comfort when working outdoors and employees
requesting a FFR for comfort while sweeping a dusty floor (63 FR 1190,
January 8, 1998). In contrast, respirator use situations under this
section of the ETS will involve employers who provide a respirator or
employees who want to wear a respirator, out of an abundance of
caution, as enhanced protection against COVID-19. They may also opt to
wear respirators other than FFRs (e.g., elastomeric respirators,
PAPRs), particularly given the supply shortages of N95 FFRs experienced
during the COVID-19 pandemic. Thus, the circumstances of respirator use
in the ETS are not merely to accommodate individual conditions or
comfort, but rather in recognition of some increased risk due to
asymptomatic and pre-symptomatic transmission of COVID-19 that is not
expected to rise to the level where respirators are required for
exposure to suspected or confirmed sources of COVID-19.
OSHA emphasizes that while the new set of requirements for
respirator use under the ETS differ in some aspects from those
specified under the Respiratory Protection standard, their intent
remains the same; that is, employers who provide respirators at the
request of their employees or who allow their employees to bring their
own respirators into the workplace must ensure that the respirator used
does not present a hazard to the health of the employee.
In the 1998 rulemaking, OSHA concluded in the rare case where an
employee is voluntarily using other than a filtering facepiece (dust
mask) respirator (paragraph (c)(2)(ii)), the employer must implement
some of the elements of a respiratory protection program, e.g., the
medical evaluation component of the program and, if the respirator is
to be reworn, the cleaning, maintenance, and storage components. An
exception to this paragraph makes clear that, where voluntary
respirator use involves only filtering facepieces (dust masks), the
employer is not required to implement a written program. While medical
evaluation is required when employees are voluntarily wearing
respirators other than FFRs under the Respiratory Protection standard,
there are no requirements under the ETS to provide medical evaluations
for employees wearing such respirators. The agency concludes that it
would be too onerous and costly for employers to provide medical
evaluations to employees wearing elastomeric respirators or PAPRs in
place of FFRs used in accordance with crisis capacity strategies during
the short period of the ETS. However, OSHA's experience with its
Respiratory Protection standard suggests that respiratory protection
can still be effective even when subject to particular safety
provisions, but not subject to the full range of requirements. In place
of medical evaluations, the agency has included a training requirement
on how to recognize medical signs and symptoms that may
limit or prevent the effective use of employer-provided respirators and
what to do if the employee experiences signs and symptoms (29 CFR
1910.504(d)(1)(v)), as well as a requirement for the discontinuation of
employer-provided respirator use (see 29 CFR 1910.504(d)(4)). This
requirement mandates that employees who wear employer-provided
respirators must discontinue respirator use when the employer or
supervisor reports medical signs or symptoms that are related to their
ability to use a respirator. In addition, any employee who previously
had a medical evaluation and was determined to not be medically fit to
wear a respirator should not be provided with an employer-provided
respirator under the ETS.
The ETS does not require employers to include any of the use
requirements specified under the ETS into a written respiratory
protection program. OSHA concludes that it would be too onerous for
employers to incorporate these requirements into a written respiratory
protection program during the short period of the ETS, particularly for
those employers who have no need to have a written respiratory
protection program in place for required respirator use. OSHA
reemphasizes that the intent of the requirements in the mini
respiratory protection program are to ensure that employees are
provided with information to safely wear respirators, without imposing
the burden of additional requirements for a written respiratory
protection program on employers.
OSHA notes that unlike the voluntary use requirements specified
under the Respiratory Protection standard, there are different
requirements for the use of employee-provided respirators as compared
to those for employer-provided respirators under the mini respiratory
protection program section. This is because the agency is requiring
employers to permit the use of employee-provided respirators. OSHA
concludes that it is necessary to permit employees to wear their own
respirators in healthcare settings given the risk for asymptomatic and
pre-symptomatic transmission and the nature of much of the work that
precludes such control measures as physical distancing and barriers.
However, the agency concludes that it would be too onerous to mandate
as many requirements for such use as are mandated when employers are
given the option of whether or not to provide employees with
respirators for use.
III. Requirements for Employee-Provided Respirators
In the 1998 rulemaking, OSHA determined that complete training is
not required for employees using respirators voluntarily; instead, the
final rule required employers to provide the information contained in
Appendix D to the Respiratory Protection standard, entitled
``Information for Employees Using Respirators When Not Required Under
the Standard,'' to ensure that employees are informed of proper
respirator use and the limitations of respirators (63 FR 1190-1192,
January 8, 1998). Under the ETS, there is only one requirement for the
use of employee-provided respirators. This requirement is for the
employer to provide these employees with a specific notice, as
specified under paragraph (c) of the mini respiratory protection
program section. This notice is almost identical to the notice
contained in Appendix D to the Respiratory Protection standard, with
some minor changes intended only to tailor the information to the
situational needs of the COVID-19 pandemic.
IV. Requirements for Employer-Provided Respirators
As noted above, under the ETS, the requirements for the use of
employer-provided respirators are more expansive under the mini
respiratory protection program section than the requirements for
employee-provided respirators. However, OSHA notes that employers are
not obligated by the ETS to provide employees with respirators for use
under the mini respiratory protection program section, so these
requirements are only mandated when an employer voluntarily provides
employees with respirators for use under the mini program. The
requirements include provisions pertaining to training, user seal
checks, reuse of respirators, and discontinuing use of respirators.
When employers choose to provide respirators to employees, the same
rationale applies as it did in the 1998 rulemaking requiring employers
to undertake these minimal obligations when they allow voluntary
respirator use is consistent with the fact that employers control the
working conditions of employees and are therefore responsible for
developing procedures designed to protect the health and safety of the
employees. Employers routinely develop and enforce rules and
requirements for employees to follow based on considerations of safety.
For example, although an employer allows employees discretion in the
types of clothing that may be worn on site, the employer would prohibit
the wearing of loose clothing in areas where clothing could get caught
in machinery, or prohibit the use of sleeveless shirts where there is a
potential for skin contact with hazardous materials. Similarly, if an
employer determines that improper or inappropriate respirator use
presents a hazard to the wearer, OSHA finds that the employer must
exert control over such respirator use and take steps to see that
respirators are safely used under an appropriate program (63 FR 1190-
1191, January 8, 1998).
The training requirements for the use of employer-provided
respirators expand on the basic respirator awareness notice required
for the use of employee-provided respirators. They require the employer
to provide training on: (a) How to inspect, put on and remove, and use
a respirator; (b) the limitations and capabilities of the respirator,
particularly when the respirator has not been fit tested; (c)
procedures and schedules for storing, maintaining, and inspecting
respirators; (d) how to perform a user seal check as described in
paragraph (e) of this section; and (e) how to recognize medical signs
and symptoms that may limit or prevent the effective use of respirators
and what to do if the employee experiences signs and symptoms. These
training requirements for respirator use are similar to the training
requirements mandated under the Respiratory Protection standard for
required respirator use. (See 29 CFR 1910.134(k)). OSHA concludes that
more extensive training provisions are required for the use of
employer-supplied respirators under the ETS because such use is likely
to be based on other factors related to the risk of COVID-19, including
the ability to implement other control measure (e.g., physical
distancing and barriers).
The user seal check requirements mandate employers to ensure that
employees conduct user seal checks and to ensure the employees correct
any problems discovered during the user seal check. This is similar to
the user seal check provision for required respirator use under the
Respiratory Protection standard. (See 1910.134(g)(1)(iii)). OSHA
concludes that ensuring that user seal checks are conducted is
necessary because employees who wear respirators are not required to be
fit tested under the ETS. OSHA notes that, in the 1998 rulemaking, OSHA
concluded that user seal checks are important in assuring that
respirators are functioning properly, and that although user seal
checks are not as objective a measure of facepiece leakage as a fit
test, they do
provide a quick and easy means of determining that a respirator is
seated properly (63 FR 1239-40, January 8, 1998). Given that employees
who choose to wear employer-provided respirators will likely be doing
so out of an abundance of caution to protect against potential airborne
transmission of SARS-CoV-2 and will not be fit tested, OSHA concludes
that it is necessary for employers to train employees how to conduct a
user seal check and to ensure that they are performed properly in order
to improve the effectiveness of the respirator.
In the 1998 rulemaking, OSHA determined that ``if the respirators
being used voluntarily are reused, it is necessary to ensure that they
are maintained in proper condition to ensure that the employee is not
exposed to any contaminants that may be present in the facepiece, and
to prevent skin irritation and dermatitis associated with the use of a
respirator that has not been cleaned or disinfected'' (63 FR 1190,
January 8, 1998). To this end, and given the potential for supply
shortages of FFRs necessitating their reuse under certain circumstances
during the COVID-19 pandemic, OSHA concludes that it is necessary to
add specific requirements for the reuse of respirators used
voluntarily. These requirements incorporate some CDC recommendations
for the reuse of FFRs used in accordance with crisis capacity
strategies (CDC, April 9, 2021).
References
Centers for Disease Control and Prevention (CDC). (2021, April 9).
Strategies for Optimizing the Supply of N95 Respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021).
H. Aerosol-Generating Procedures on Persons With Suspected or Confirmed
COVID-19
As explained in more detail in Grave Danger (Section IV.A. of the
preamble), aerosol-generating procedures (AGP) are well-known to be
high-risk activities for exposure to respiratory infections. Workers in
a wide range of settings, such as emergency responders, healthcare
providers, and medical examiners performing autopsies, are at risk
during AGPs. For the purposes of the ETS, only the following procedures
are considered AGPs: Open suctioning of airways, sputum induction,
cardiopulmonary resuscitation, endotracheal intubation and extubation,
non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, manual
ventilation, medical/surgical/postmortem procedures using oscillating
bone saws, and dental procedures involving ultrasonic scalers, high-
speed dental handpieces, air/water syringes, air polishing, and air
abrasion. For further information on why these procedures are
considered AGPs under the ETS, please see the discussion of aerosol-
generating procedures in Section VIII, Summary and Explanation.
The CDC provides extensive guidance for performance of AGPs (CDC,
February 23, 2021). First, exposure should be limited where possible.
The CDC recommends that the use of procedures or techniques that might
produce infectious aerosols should be minimized when feasible, as
should the number of people in the room.
CAP has also recognized the risks involved in conducting AGPs by
recommending limiting the use of aerosol-generating tools, such as
oscillating bone saws, during autopsies on COVID-19-positive cases
(College of American Pathologists, February 2, 2021). Post-mortem
procedures using oscillating bone saws have specifically been noted as
a COVID-19-related exposure concern (Nolte et al., December 14, 2020).
The following controls are therefore recommended for autopsies
involving the use of oscillating bone saws: Isolation rooms, limiting
the number of people in the room who are exposed, negative pressure
ventilation, adequate air exchange, double door access, and use of
respirators.
As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 may spread through infectious aerosols
during AGPs. Therefore, where these procedures must be performed, there
are two important controls for these situations: Ventilation (for
example, in the form of air infection isolation rooms (AIIR), if
available) and respiratory protection. Both of these controls are
required for AGPs in the ETS. For more information on why there is a
need to include in this ETS a requirement for respirators during
aerosol-generating procedures, please see Need for Specific Provisions
(Section V of this preamble) on Respirators.
It is well-established that insufficient ventilation increases the
risk of airborne disease transmission; indeed, this is the foundation
for the World Health Organization recommendations on ventilation in
healthcare settings (Atkinson et al., 2009). When air is stagnant or
poorly ventilated, aerosols may increase in concentration and increase
exposure. Both a lack of ventilation and inadequate ventilation are
associated with increased infection rates of airborne diseases.
Increasing ventilation rates has been shown to decrease transmission
risk of airborne disease. Ventilation is able to direct airflow away
from uninfected individuals, which reduces risk of transmission.
The American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE) is the authoritative organization for ventilation
standards in the U.S. The U.S. Army Corps of Engineers (USACE) has been
tasked by the U.S. Federal Emergency Management Agency with the design
and construction of alternative care sites during surges in the COVID-
19 pandemic. USACE requested that ASHRAE provide engineering guidance
for ventilation within alternative care sites. The resulting joint
ASHRAE/USACE document makes recommendations for removal of aerosols
generated by patients during AGPs and other patient care activities in
alternative care sites (ASHRAE and USACE. November 20, 2020).
Additionally, ASHRAE provides specific guidance on source control and
AIIRs related to aerosol-generating procedures during the COVID-19
pandemic (ASHRAE, January 30, 2021).
Airborne infection isolation rooms (AIIR) are specifically designed
to control the spread of aerosols and prevent airborne transmission of
disease (Sehulster and Chinn, June 6, 2003). An AIIR has negative
pressure in comparison to accessible areas outside the room, which
causes air to flow into (rather than out of) the room from the room's
access points when they are open (e.g., an open door). When the access
points (e.g., the door) are closed and ventilation is adequate,
contaminated air cannot escape at all into the rest of the facility.
Air exhaust can be delivered directly outdoors or passed through a
special high-efficiency (HEPA) filter. In this way, AIIRs minimize
potentially contaminated air flow outward into the rest of the
facility.
Because of the risk of airborne transmission, the CDC recommends
the use of AIIRs when AGPs are performed on patients with suspected or
confirmed COVID-19. However, increased protection for workers
performing AGPs is not a new recommendation solely for the COVID-19
pandemic. The CDC and WHO both routinely recommend higher levels of
personal protective equipment for workers performing these procedures
on patients with other respiratory infections (CDC, October 30, 2018).
The CDC recommendations for AGPs performed on influenza patients
specify use of AIIRs when feasible. The
recommendations also specify that the use of portable HEPA filtration
units to further reduce the concentration of contaminants in the air
should be considered. Similarly, the World Health Organization
recommends more protective respirators for AGPs (WHO, April, 2008).
Finally, the National Institute for Occupational Safety and Health
(NIOSH) has developed a ventilated headboard that can be used to reduce
employee exposure to patient-generated aerosols containing respiratory
pathogens (NIOSH, May 26, 2020).
References
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2021, January 30). Guide to the COVID-19 Pages.
https://www.ashrae.org/technical-resources/healthcare. (ASHRAE,
January 30, 2021).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE) and United States Army Corps of Engineers
(USACE). (2020, November 20). Alternate Care Site HVAC Guidebook.
https://www.ashrae.org/about/news/2020/new-alternative-care-site-guidebook-available-to-help-respond-to-the-rising-need-for-hospital-beds-due-to-covid-19. (ASHRAE and USACE, November 20, 2020).
Atkinson, J et al., (2009). Natural Ventilation for Infection
Control in Health-Care Setting World Health Organization Guidelines.
https://www.who.int/water_sanitation_health/publications/natural_ventilation/en/. (Atkinson et al., 2009).
Centers for Disease Control and Prevention (CDC). (2018, October
30). Prevention strategies for seasonal influenza in healthcare
settings. https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm. (CDC, October 30, 2018).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
College of American Pathologists. (2021, February 2). Amended COVID-
19 autopsy guideline statement from the CAP Autopsy Committee.
https://documents.cap.org/documents/COVID-Autopsy-Statement.pdf.
(College of American Pathologists, February 2, 2021).
National Institute for Occupational Safety and Health (NIOSH).
(2020, May 26). Worker protective controls--engineering controls to
reduce airborne, droplet and contact exposures during epidemic/
pandemic response. https://www.cdc.gov/niosh/topics/healthcare/engcontrolsolutions/ventilated-headboard.html. (NIOSH, May 26,
2020).
Nolte, K. et al., (2020, December 14). Design and construction of a
biosafety level-3 autopsy laboratory. Arch Path Lab Med. doi:
10.5858/arpa.2020-0644-SA. (Nolte et al., December 14, 2020).
Sehulster, L. and Chinn, R. (2003, June 6). Guidelines for
Environmental Infection Control in Health-Care Facilities. MMWR
52(RR10); 1-42. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm. (Sehulster and Chinn, June 6, 2003).
World Health Organization (WHO). (2008, April). Epidemic- and
pandemic-prone acute respiratory diseases--Infection prevention and
control in health care. https://www.who.int/csr/resources/publications/aidememoireepidemicpandemid/en/. (WHO, April, 2008).
I. Physical Distancing
The best available current scientific evidence demonstrates that
COVID-19 spreads mainly through transmission between people who are
physically near each other. The basic concept is that the majority of
respiratory droplets expelled from an infected person through talking,
coughing, breathing, or sneezing can travel a limited distance before
falling to the surface below due to gravity. Therefore, the farther a
person is away from the source of the respiratory droplets, the fewer
infectious viral particles are likely to reach that person's eyes,
nose, or mouth. The fewer infectious viral particles that reach that
person, the lower the risk of transmission. Additional explanation of
transmission is discussed in Grave Danger (Section IV.A. of the
preamble). OSHA recognizes that this is a simplification of the complex
issue of how droplets and aerosols moving through space applies to the
transmission of SARS-CoV-2. Nonetheless, the broad scientific
principles described in this preamble enable OSHA to describe to
affected employers and employees why the protective measures required
by this ETS are necessary to protect employees from exposure to the
virus.
The research described below demonstrates that a significant factor
in determining whether a healthy employee will become infected with
COVID-19 is how close that employee is to other people (e.g., co-
workers, patients, visitors, delivery people). Infected individuals can
transmit the virus to others whether or not the infected person is
experiencing symptoms, and symptoms may not be immediately noticeable,
so it is important to keep all employees distanced from other people
whether or not those other people exhibit symptoms. Symptomatic,
asymptomatic, and pre-symptomatic transmission is discussed further in
Grave Danger (Section IV.A. of the preamble). The role that physical
distancing plays in this ETS is thus to ensure that employees are
separated from other people as much as possible so as to reduce the
risk that virus-containing droplets reach employees.
Consistent with CDC guidance, OSHA defines physical distancing as
maintaining a sufficient distance between two people--generally
considered to be at least six feet of separation--such that the risk of
viral transmission through inhalation of virus-containing particles
from an infected individual is significantly reduced. OSHA is aware of
emerging scientific literature that suggests even greater distances may
be beneficial. OSHA is also aware of some literature from other
countries that suggests less than six feet may be appropriate in some
circumstances; however, based on the evidence summarized below, OSHA
believes that anything less than six feet is not sufficient to address
the level of risk established in the studies the agency has reviewed.
While it is likely that a distance of greater than six feet will result
in some lowered risk and OSHA recommends six feet as a minimum
distance, OSHA is not aware of sufficient evidence to justify mandating
a distance farther than the six feet recommended by the CDC. Physical
distancing is a critical component of infectious disease prevention
guidelines and is a key protective measure of the current COVID-19-
specific prevention recommendations from the CDC, WHO, and other public
health entities, as discussed in greater detail below (CDC and OSHA,
March 9, 2020; WHO, June 26, 2020; CalOSHA, 2020; ECDC, March 23, 2020;
PHAC, May 25, 2020).
The importance of physical distancing is evident from CDC's
guidance for determining who qualifies as close contacts of an
individual who is COVID-19 positive. People who have been in close
contact with a COVID-19-positive individual are most likely to become
infected. To become infected with COVID-19, a healthy individual
typically needs to inhale a certain amount of viral particles (i.e., an
infectious dose). The closer that healthy individual is to an infected
person emitting infectious viral particles, the greater their exposure
may be. In practice, a person generally needs to be both close enough
to an infectious person and near them long enough to inhale an
infectious dose. The CDC acknowledges the potential for inhalation at
distances greater than six feet from an infectious source, but notes
that this is less likely than at a closer distance (CDC, May 7, 2021).
This continues to support OSHA's recommendation for a minimum distance
of six feet. It is also important to note that multiple short exposures
over the course of a day can add up to a long enough period of time to
receive an infectious dose of COVID-19. Therefore, CDC's definition of
close contact is dependent on both proximity to one or more infected
people and the time period over which that proximity occurred. The CDC
defines close contact as ``someone who was within 6 feet of an infected
person for a cumulative total of 15 minutes or more over a 24-hour
period starting from 2 days before illness onset (or, for asymptomatic
patients, 2 days prior to test specimen collection) until the time the
patient is isolated'' (CDC, March 11, 2021). The CDC uses this close
contact designation to help determine contact tracing to minimize
transmission spread and to help communicate the risk of transmission to
the public.
The CDC close contact definition describes the likely context for
transmission events under most circumstances. However, it should be
noted that infections can occur from exposures of less than 15 minutes.
For example, one infection event was documented that resulted from only
roughly five minutes of exposure (Kwon et al., November 23, 2020).
Thus, distancing may reduce COVID-19 exposure during even short periods
of exposure.
The notion that physical distancing can protect a healthy
individual from respiratory droplets is well established for droplet-
transmissible diseases and has been a topic of study for well over a
hundred years (Flugge, 1897; Jennison, 1942; Duguid, November 1, 1945;
Wells, November 1, 1955). Carl Flugge (1897) is credited with
originating the concept of droplet transmission. In his study using
settling plates to collect large droplets that were emitted from an
individual, he found that droplets fell to the plates within two meters
(approximately 6.6 feet). Combining this knowledge with the known
presence of infectious materials in respiratory droplets, Flugge
suggested that remaining two meters from infected individuals would be
protective. This understanding of droplet transmission was further
expanded a few decades later, when William F. Wells noted that in
Flugge's study, Flugge was unable to observe a proportion of small
droplets that would evaporate before settling on the plates and that
these evaporated droplets traveled differently, suggesting that some
measure of transmission may happen beyond the large droplet
transmission that Flugge observed (Wells, November 1, 1934).
Subsequently, in the 1940s and 1950s, high-speed photography improved
to the point where it could capture, upon emission, most of the
respiratory droplets--large and small--that formed; this line of study
validated much of the groundwork that Flugge and Wells laid (Jennison,
1942; Duguid, November 1, 1945; Hamburger and Robertson, May 1, 1948;
Wells, November 1, 1955). These studies illustrated that large droplets
can be a major driver of disease transmission, but also that there
might be exceptions to the effectiveness of physical distancing when it
comes to virus-laden small droplets.
Even though COVID-19 is a recent disease, evidence of the
effectiveness of physical distancing in reducing exposures to SARS-CoV-
2 has been illustrated through a variety of scientific approaches,
including an experimental study by Ueki et al., (October 21, 2020), a
modeling study by Li et al., (November 3, 2020), and real world
observational studies by Chu et al., (June 27, 2020) and Doung-ngern et
al., (September 14, 2020). In a controlled laboratory experiment
performed by Ueki et al., (October 21, 2020), researchers developed a
scenario where 6 mL of SARS-CoV-2 viral serum was nebulized from a
mannequin's mouth to form a mist that simulated a cough. Another
mannequin, which was outfitted with an artificial ventilator set to an
average adult ventilation rate, collected a proportion of the mist at
distances of 0.25 meters (approximately 0.8 feet), 0.5 meters
(approximately 1.6 feet), and 1 meter (approximately 3.3 feet). Using
the 0.25-meter distance as a baseline, increasing the distance between
the mannequins reduced viral particle exposure (measured as the number
of viral RNA copies) by 62% at 0.5 meters and 77% at 1 meter. The study
clearly illustrates the increased protection from viral exposure that
results from increasing distance between individuals.
Modeling studies also provide evidence supporting the effectiveness
of physical distancing in preventing exposure to SARS-CoV-2. In Li et
al., (November 3, 2020), researchers modeled exposures resulting from
respiratory droplets dispersed from a simulated typical cough using
simulated saliva with a SARS-CoV-2 viral concentration measured from
infected individuals. The simulated cough emitted 30,558 viral copies
at distances of one meter (approximately 3.3 feet) and two meters
(approximately 6.6 feet) between the infectious person and the person
exposed. At one meter, more than 65% of the droplet volume (about
20,000 viral copies) reached the recipient. However, almost all of the
exposure was deposited below the head, with only 9 viral copies
estimated to land on the area that would normally be covered by a face
covering. When the distance was increased to two meters, 63 viral
copies landed on the recipient, with only 0.6 copies expected to hit
the face covering area. This study illustrates not only the benefit of
distance for reducing inhalation exposure, but also for reducing
contamination of clothing, which can contribute to overall exposure if
a person touches their contaminated clothing and then touches their
eyes, nose, or mouth.
Outside of experimental and modeling scenarios, observations in
real world situations also substantiate the finding that increasing
physical distance protects people from developing infections. A
systematic review of 172 studies on SARS-CoV-2 (up to early May 2020),
SARS-CoV-1 (a viral strain related to SARS-CoV-2), and Middle Eastern
Respiratory Syndrome (MERS) (a disease caused by a virus that is
similar to SARS-CoV-2 and spreads through droplet transmission) found
38 studies, containing 18,518 individuals, to use in a meta-analysis
that evaluated the effectiveness of physical distancing (Chu et al.,
June 27, 2020). The researchers compared the infection rates for
individuals who were within one meter (approximately 3.3 feet) of
infected people versus the infection rates for those who were greater
than one meter away. For individuals who were within one meter, the
chance of viral infection was 12.8%. When distance was greater than one
meter, the chance of viral infection decreased to 2.6%. Furthermore,
researchers projected that with each additional meter of distance the
risk would be reduced by an additional 2.02 times.
The importance of physical distancing even when people are not
exhibiting symptoms was further demonstrated by a COVID-19 study from
Thailand. Researchers reviewed physical distancing information
collected from 1,006 individuals who had an exposure to infected
individuals (Doung-ngern et al., September 14, 2020). At the time of
the exposure, many of the infected individuals were not yet
experiencing symptoms, and none of the exposed individuals included in
the study were experiencing symptoms. The researchers contacted the
individuals 21 days after their exposures to determine if any secondary
infections had occurred. Out of 1,006 participants, 197 tested positive
and 809 either tested
negative or were considered low risk contacts, did not exhibit symptoms
and, therefore, were not tested. The researchers then compared the
incidence of secondary infections to data on how close the exposed
individuals were to the infected individuals. Exposed individuals were
placed into three groups: Those who had direct physical contact with
the infected individual, those who were within one meter (approximately
3.3 feet) but without physical contact, and those who remained more
than one meter away. The study revealed that the group with direct
physical contact and the group within one meter but without physical
contact were equally likely to become infected with SARS-CoV-2.
However, the group that remained more than one meter away had an 85%
lower infection risk than the other two groups.
As noted earlier, there is additional nuance to droplet fate beyond
just the general effects of gravity on large droplets. Studies
evaluating the dispersion of aerosols (i.e., particles that are smaller
than typical droplets) and atypical droplets in the air have created a
more thorough understanding of disease transmission and the limitations
on the effectiveness of physical distancing (Jones et al., August 25,
2020). The distance that droplets may be able to travel depends on
their size, expelled velocity, airflow, and other environmental
considerations (Xie et al., May 29, 2007; Dbouk and Drikakis, May 1,
2020; Li et al., April 22, 2020). Bahl et al., (April 16, 2020)
reviewed ten studies on the horizontal spread of droplets, finding that
seven of the studies observed maximum distances traveled by droplets
that greatly exceeded two meters (approximately 6.6 feet); one of which
suggested the possibility of travel up to eight meters (approximately
26.2 feet). Several case studies have identified incidents where
transmission of SARS-CoV-2 occurred over distances of 15.1 feet (Li et
al., April 22, 2020), 21.3 feet (Kwon et al., November 23, 2020) and
26.2 feet (Gunther et al., October 27, 2020). These studies suggest
that while maintaining a physical distance of two meters reduces
transmission significantly, there is still some risk of transmission
beyond two meters. Thus, these studies illustrate that physical
distancing is an important control, but also why physical distancing
alone is insufficient, and a multi-layered strategy that includes
additional control measures is necessary to protect employees from
contracting COVID-19.
As demonstrated by the studies above, it is widely accepted that
physical distancing reduces transmission of infectious diseases
generally, and COVID-19 specifically. While the specific distance
needed to ensure maximum reduction of COVID-19 transmission can be
debated, six feet has long been used in the U.S. as the minimum
acceptable distance in most situations to prevent transmission of
droplet-transmissible infectious diseases, and the CDC has recommended
that distance to combat COVID-19 since the start of the pandemic (CDC
and OSHA, March 9, 2020).
Physical distancing strategies can be applied on an individual
level (e.g., avoiding coming within six feet of another individual), a
group level (e.g., canceling group activities where individuals would
be in close contact), and an operational level (e.g., promoting
telework, reconfiguring the infrastructure or reducing facility
occupancy levels to allow sufficient space for physical distancing). As
described in further detail in Summary and Explanation (Section VIII of
the preamble), CDC and OSHA have identified various approaches to
maintaining physical distance between employees, such as: Reducing the
number of employees on-site at one time; reducing facility occupancy
levels (both for employees and non-employees); staggering arrival,
break, and departure times to maintain distancing during specific times
at work when adherence is difficult; and holding on-site training or
meeting activities in larger spaces to allow for sufficient distance
between attendees (CDC and OSHA, March 9, 2020).
Physical distancing practices and recommendations are also well-
accepted internationally as an effective measure to reduce the spread
of COVID-19. The World Health Organization (WHO) recommends physical
distance of at least one meter (approximately 3.3 feet) in all
workplace settings, with a preference for two meters (approximately 6.6
feet) (WHO, June 26, 2020). WHO also recommends providing sufficient
work space of at least 10 square meters for each employee where it is
feasible based on work tasks. Some foreign governments have implemented
physical distancing requirements and recommendations varying in
distances of: One meter (e.g., Hong Kong, Singapore, United Kingdom,
Norway), 1.5 meters (e.g., Germany, Spain), and 2 meters (e.g., Japan,
South Korea, Canada) (Han et al., November 7, 2020; PHAC, May 25,
2020). While the required or recommended amount of distance varies
between jurisdictions, it is clear that physical distancing is
considered to be a critical tool in preventing the spread of COVID-19
around the world and that, even where six feet of distance cannot be
maintained, maintaining as much distance as possible can help minimize
the possibility of disease transmission (Chu et al., June 27, 2020;
Doung-ngern et al., September 14, 2020; Li et al., November 3, 2020;
Ueki et al., 2020).
Based on the best available evidence, the agency concludes that
physical distancing of at least six feet is an effective and necessary
tool to protect employees from COVID-19 by reducing incidence of COVID-
19 illness. This conclusion applies to physical distancing on its own
and also when complemented by other measures as part of a multi-layered
strategy to minimize employee exposure to COVID-19.
References
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for Health Workers Treating Coronavirus Disease 2019. The Journal of
Infectious Diseases jiaa189. https://doi.org/10.1093/infdis/jiaa189.
(Bahl et al., April 16, 2020).
California Division of Occupational Safety and Health (CalOSHA).
(2020). COVID-19 Prevention Emergency Standard. OSHSB-98(2/98).
(CalOSHA, 2020).
Centers for Disease Control and Prevention (CDC) and 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. (CDC and OSHA, March 9,
2020).
Centers for Disease Control and Prevention (CDC). (2021, March 11).
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(CDC, March 11, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks,
and Eye Protection to Prevent Person-to-Person Transmission of SARS-
CoV-2 and COVID-19: a systematic review and meta-analysis. The
Lancet 395: 1973-1987. https://doi.org/10.1016/. (Chu et al., June
27, 2020).
Dbouk, T. and Drikakis, D. (2020). On Coughing and Airborne Droplet
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Doung-ngern, P. et al., (2020, September 14). Case-control Study of
Use of Personal Protective Measures and Risk for SARS Coronavirus 2
Infection, Thailand. Emerging Infectious Diseases 26, 11: 2607-2616.
https://doi.org/10.3201/
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Duguid, JP. (1945). The Numbers and the Sites of Origin of the
Droplets Expelled During Expiratory Activities. Edinburgh Medical
Journal 52, 11: 385-401. (Duguid, November 1, 1945).
European Centre for Disease Prevention and Control (ECDC). (2020,
March 23). Considerations related to social distancing measures in
response to COVID-19--second update. https://www.ecdc.europa.eu/en/publications-data/considerations-relating-social-distancing-measures-response-covid-19-second. (ECDC, March 23, 2020).
Flugge, C. (1897). Uber Luftinfection. Zeitschrift fur Hygiene und
Infektionskrankheiten 25: 179-224. (Flugge, 1897).
Gunther, T. et al., (2020, October 27). SARS-CoV-2 Outbreak
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Hamburger, M. and Robertson, OH. (1948, May 1). Expulsion of Group A
Hemolytic Streptococci in Droplets and Droplet Nuclei by Sneezing,
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(Hamburger and Robertson, May 1, 1948).
Han, E. et al., (2020, November 7). Lessons Learned from Easing
COVID-19 Restrictions: An Analysis of Countries and Regions in Asia
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Jennison, MW. (1942). Atomising of Mouth and Nose Secretions into
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Jones, NR et al., (2020, August 25). Two Metres or One: What is the
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Kwon, KS et al., (2020, November 23). Evidence of Long-Distance
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Restaurant in Korea. J Korean Med Sci 35(46): e415. https://jkms.org/DOIx.php?id=10.3346/jkms.2020.35.e415. (Kwon et al.,
November 23, 2020).
Li, H. et al., (2020, November 3). Dispersion of Evaporating Cough
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Ventilated Restaurant. PREPRINT https://doi.org/10.1101/2020.04.16.20067728. (Li, April 22, 2020).
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Ueki, H. et al., (2020, October 21). Effectiveness of Face Masks in
Preventing Airborne Transmission of SARS-CoV-2. mSphere 5: e00637-
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21, 2020).
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Droplets and Droplet Nuclei. American Journal of Epidemiology 20(3):
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Wells, WF. (1955, November 1). Airborne Contagion and Air Hygiene:
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Xie, X. et al., (2007, May 29). How far droplets can move in indoor
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May 29, 2007).
J. Physical Barriers
When people with COVID-19 cough, sneeze, sing, talk, yell, or
breathe, they produce respiratory droplets. Epidemiological research
has found that most COVID-19 transmission occurs via respiratory
droplets that are spread from an infected individual during close
(within 6 feet) person-to-person interactions (CDC, May 7, 2021; CDC,
May 13, 2021a; WHO, July 9, 2020). The amount of respiratory droplets
and particles released when a person breathes is significant, and the
amount increases when someone talks or yells (Asadi et al., February
20, 2019; Alsved et al., September 17, 2020; Abkarian et al., October
13, 2020).
Barriers can be used to minimize occupational exposure to SARS-CoV-
2. Barriers work by preventing droplets from traveling from the source
(i.e., an infected person) to an employee, thus reducing droplet
transmission. When barriers are used properly, they will intercept
respiratory droplets that may contain SARS-CoV-2. Barriers are
particularly critical when physical distancing of six feet is required
but not feasible (AIHA, September 9, 2020; Fischman and Baker, June 4,
2020; CDC, April 7, 2021; CDC, March 8, 2021; WHO, May 10, 2020;
University of Washington, October 29, 2020).
When engineering controls, such as physical barriers, are
appropriately installed and located, they can reduce exposure to
infectious agents, such as SARS-CoV-2, without relying on changes in
employee behavior (OSHA, 2009). Therefore, engineering controls are
often the most effective type of control and can also be a cost-
effective layer of protection (AIHA, September 9, 2020). Physical
barriers are not a stand-alone measure and are only one part of a
multi-layered approach for infection control. To protect employees from
exposure to SARS-CoV-2, engineering controls need to be combined with
work practice controls, administrative controls, and PPE to ensure
adequate protection (CDC, April 7, 2021; CDC, March 8, 2021).
Physical barriers, such as plastic or acrylic partitions, are well-
established and accepted as an infection control approach to containing
droplet transmissible diseases. Recommendations for the use of physical
barriers are commonly made in connection with pandemic events, such as
the 2010 pandemic influenza (see, for example, OSHA, 2009) or avian
influenza pandemics (see, for example, CDC, January 23, 2014). However,
physical barriers are recognized as effective engineering controls for
preventing the transmission of infectious agents and, therefore, have
been commonly used in other workplace settings even under non-pandemic
conditions. For instance, sneeze guards are included in the FDA's 2017
Food Code, which all 50 states use for their food safety regulations
(FDA, 2017). These barriers, typically placed in front of and above
food items, intercept contaminants, such as respiratory droplets, that
may be expelled from a person's mouth or nose (Todd et al., August 1,
2010).
Impermeable barriers intercept respiratory droplets and prevent
them from reaching another individual (Fischman and Baker, June 4,
2020; Ibrahim et al., June 1, 2020; Dehghani et al., December 22, 2020;
University of Washington, October 29, 2020). Thus, physical barriers
can be a practical solution for decreasing the transmission of
infectious viral particles for a wide range of work activities and
locations. Only barriers that keep respiratory droplets out of an
employee's breathing zone will reduce overall exposure to SARS-CoV-2.
The breathing zone is the area immediately around an individual's mouth
and nose from which a person draws air when they breathe and extends 9
inches beyond a person's nose and mouth (OSHA, February 11, 2014).
Additional considerations for the design and implementation of physical
barriers to
properly block face-to-face pathways of breathing zones, including
acceptable materials and installation, is discussed in the Summary and
Explanation (Section VIII of the preamble).
While COVID-19-related research on barriers is fairly limited due
to the recent emergence and ongoing nature of the pandemic, there is
some evidence of the effectiveness of physical barriers in healthcare
settings during the COVID-19 pandemic. Using a surrogate for SARS-CoV-
2, Mousavi et al., (August 13, 2020) designed an experimental study in
which general patient rooms in a healthcare facility were converted
into isolation rooms constructed out of plastic barriers with zipper
doors. The authors found that the use of the barrier alone could stop
the particles that contacted the barrier and prevent 80% of the
surrogate SARS-CoV-2 particles from spreading to adjacent spaces. In
contrast, without the barrier, particles were easily dispersed to other
areas of the facility. The barrier was actually more effective at
containing particles than a solid door, as the barrier did not create
changes in airflow patterns like a door does when it opens and closes.
A simulation study using a double set of plastic drapes as a
barrier around a patient's head and neck during patient intubation
found that the drapes were effective at minimizing contamination to the
healthcare provider and patient (Ibrahim et al., June 1, 2020).
Similarly, a simulation study performed in a dental healthcare setting
evaluated the use of clear, flexible barriers that were fitted over the
patient chair and covered the patient's head, neck, and chest; the
barriers had small openings for the employee's hands. The barriers were
found to reduce the number of dyed water droplets landing on the
provider and in the surrounding work environment during the dental
procedure (Teichert-Filho et al., August 18, 2020). A simulation study
of peroral endoscopy procedures performed through the mouth found that
the use of an acrylic box around a patient's head during the procedure
may reduce the number of droplets transmitted to the providers
performing the procedure (Gomi et al., October 21, 2020).
A separate group of researchers developed a simulation study in an
open work station environment to evaluate how physical barriers may
impact disease transmission. They found that physical barriers were
able to reduce the transmission of simulated 1um aerosolized particles
from a source individual to others who were over 6 feet away by 92%
(Abuhegazy et al., October 20, 2020). OSHA notes that it would be
expected that large droplets, as opposed to aerosolized particles,
would be reduced to a greater extent because they do not remain
airborne for extended periods of time unlike aerosolized particles, as
noted in the Physical Distancing section of the Need for Specific
Provisions analysis.
Researchers found that a COVID-19 outbreak among hospital food
service employees was effectively contained with the prompt
implementation of physical barriers in the workplace where physical
distancing was not implemented (Hale and Dayot, August 13, 2020). This
included installing partitions at cashier stations between employees
and non-employees, as well as in food preparation areas between
workstations (Hale and Dayot, August 13, 2020). While this evidence of
the effectiveness of barriers was not drawn from healthcare settings,
the same concept would be equally applicable to preventing transmission
between people at similarly fixed locations in healthcare facilities,
such as barriers separating a receptionist from a patient in intake or
barriers separating workers sitting side by side at desks in a
hospital's administrative office.
It is not clear, however, that barriers are necessary to separate
fully vaccinated employees from employees who are not fully vaccinated
and are not suspected or confirmed to have COVID-19. As discussed in
the Grave Danger section and in the explanation for the scope exception
in Sec. 1910.501(a)(4), the CDC has acknowledged a ``growing body'' of
evidence that vaccination can reduce the potential that a vaccinated
person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers
(CDC, April 12, 2021; CDC, May 13, 2021b).
Based on the best available evidence, the agency concludes that
physical barriers are an effective and necessary means of, and play a
vital role in, reducing transmission of SARS-CoV-2 when complemented by
other measures as part of a multi-layered strategy to minimize the
risks of employee exposure to SARS-CoV-2 by employees who are not fully
vaccinated or from non-employees.
References
Abkarian, M. et al., (2020, October 13). Speech can produce jet-like
transport relevant to asymptomatic spreading of virus. PNAS 117: 41,
25237-25245. https://www.pnas.org/cgi/doi/10.1073/pnas.2012156117.
(Abkarian et al., October 13, 2020).
Abuhegazy, A. et al., (2020, October). Numerical investigation of
aerosol transport in a classroom with relevant to COVID-19. Physics
of Fluids 32, 103311. https://doi.org/10.1063/5.0029118. (Abuhegazy
et al., October 20, 2020).
Alsved, M. et al.,(2020, September 17). Exhaled respiratory
particles during singing and talking. Aerosol Science and Technology
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(Alsved et al., September 17, 2020).
American Industrial Hygiene Association (AIHA). (2020, September 9).
Reducing the Risk of COVID-19 Using Engineering Controls: Guidance
Document. https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Guidance-Documents/Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9,
2020).
Asadi, S et al., (2019, February 20). Aerosol emission and
superemission during human speech increase with voice loudness.
Scientific Reports 9: 2348. https://doi.org/10.1038/s41598-019-38808-z. (Asadi et al., February 20, 2019).
Centers for Disease Control and Prevention (CDC). (2014, January
23). Interim Guidance for Infection Control Within Healthcare
Settings When Caring for Confirmed Cases, Probable Cases, and Cases
Under Investigation for Infection with Novel Influenza A Viruses
Associated with Severe Disease. https://www.cdc.gov/flu/avianflu/novel-flu-infection-control.htm. Accessed January 28, 2021. (CDC,
January 23, 2014).
Centers for Disease Control and Prevention (CDC). (2021, April 12).
Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. (CDC, April
12, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 13).
How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 13).
Interim Public Health Recommendations for Fully Vaccinated People.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, May 13, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 7).
COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/office-buildings.html.
(CDC, April 7, 2021).
Dehghani, F. et al., (2020, December 22). The hierarchy of
preventive measures to
protect workers against the COVID-19 pandemic: A review. Work 67:
771-777. DOI: 10.3233/WOR-203330. (Dehghani et al., December 22,
2020).
Fischman, ML and Baker, B. (2020, June 4). COVID-19 Resource Center.
American College of Occupational and Environmental Medicine [ACOEM].
https://acoem.org/COVID-19-Resource-Center/COVID-19-Q-A-Forum/Could-you-provide-guidance-on-the-use-of-plexiglass-barriers-for-workplaces-for-sneeze-guard%E2%80%9D-dropl. (Fischman and Baker,
June 4, 2020).
Food and Drug Administration (FDA). (2017). Food Code: 2017
Recommendations of the United States Public Health Service, Food and
Drug Administration. (FDA, 2017).
Gomi, K. et al., (2020, October 21). Peroral endoscopy during the
COVID-19 pandemic: Efficacy of the acrylic box (Endo-Splash
Protective (ESP) box) for preventing droplet transmission. Journal
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jgh3.12438. (Gomi et al., October 21, 2020).
Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in
Hospital Food Service Workers. American Journal of Infection
Control. S0196-6553(20)30777-X. https://doi.org/10.1016/j.ajic.2020.08.011. (Hale and Dayot, August 13, 2020).
Ibrahim, M. et al., (2020, June 1). Comparison of the effectiveness
of different barrier enclosure techniques in protection of
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Anesthesia and Analgesia Practice 14: 3. DOI: 10.1213/
XAA.0000000000001252. (Ibrahim et al., June 1, 2020).
Mousavi, ES et al., (2020, August 13). Performance analysis of
portable HEPA filters and temporary plastic anterooms on the spread
of surrogate coronavirus. Building and Environment 183: 107186.
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August 13, 2020).
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Occupational Safety and Health Administration (OSHA). (2014,
February 11). OSHA Technical Manual, Section II: Chapter 1--Personal
Sampling for Air Contaminants. https://www.osha.gov/dts/osta/otm/otm_ii/otm_ii_1.html. (OSHA, February 11, 2014).
Teichert-Filho, R. et al., (2020, August 18). Protective device to
reduce aerosol dispersion in dental clinics during the COVID-19
pandemic. International Endodontic Journal. doi: 10.1111/iej.13373.
(Teichert-Filho et al., August 18, 2020).
Todd, ECD et al., (2010, August 1). Outbreaks where food workers
have been implicated in the spread of foodborne disease. Part 7.
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Prevention Efforts. University of Washington Environmental Health &
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October 29, 2020).
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public health and social measures in the workplace context of COVID-
19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO,
May 10, 2020).
World Health Organization (WHO). (2020, July 9). Transmission of
SARS-CoV-2: Implications for infection prevention precautions.
https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO,
July 9, 2020).
K. Hygiene and Cleaning
COVID-19 can also be spread through contact transmission, which
occurs when a person touches another person who has COVID-19 (e.g.,
during a handshake) or a surface or item contaminated with the virus
(e.g., workstations, shared equipment or products) and then touches
their own eyes, nose, or mouth (CDC, May 13, 2021; CDC, April 5,
2021d). Contact transmission via inanimate objects is also known as
fomite transmission. While contact transmission is less common than
droplet transmission, and the risk of infection from touching a surface
is low, contracting COVID-19 via contact transmission remains a concern
in the workplace. Contact transmission is discussed in greater detail
in Grave Danger (Section IV.A. of the preamble).
To protect against COVID-19 transmission, the CDC has recommended
cleaning and situational disinfecting of high-touch surfaces, as well
as frequent handwashing, as key prevention methods (CDC, April 5,
2021a, and CDC, May 17, 2020, respectively). Cleaning means the removal
of dirt and impurities, including germs, from surfaces using soap and
water or other cleaning agents (i.e., not Environmental Protection
Agency (EPA)-registered disinfectants). Cleaning alone reduces germs on
surfaces by removing contaminants and may also weaken or damage some of
the virus particles, which decreases risk of infection from surfaces.
Disinfection means using an EPA-registered List N disinfectant in
accordance with manufacturers' instructions to kill germs on surfaces
or objects. Disinfection further lowers the risk of spreading infection
and the CDC recommends disinfection in indoor community settings where
there has been a suspected or confirmed COVID-19 case in the previous
24 hours (CDC, April 5, 2021d).
I. Cleaning and Hand Hygiene Are Most Effective in Combination
Based on the best available evidence, OSHA has determined that
proper hand hygiene, cleaning, and situational disinfection of high-
touch surfaces and surfaces touched by someone with COVID-19 are
critical provisions of the ETS, both on their own and also when
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to this grave COVID-19 danger. Practicing
proper hand hygiene combined with routine cleaning of contact surfaces,
minimizes the risk of contracting COVID-19 through contact with
contaminated surfaces, followed by touching the mouth, nose, or eyes
(Honein et al., December 11, 2020). Cleaning surfaces removes harmful
contaminants from surfaces, reducing the risk of COVID-19 transmission
following hand contact with those surfaces. Disinfection of surfaces
and equipment in indoor community settings should be done if a
suspected or confirmed COVID-19 case was utilizing those areas within
the past 24 hours (CDC, April 5, 2021d). Cleaning, disinfection, and
hand hygiene are foundational components of Standard and Transmission-
Based Precautions for infection control and prevention (Siegel et al.,
2007).
II. Cleaning and Disinfection
Respiratory secretions or droplets expelled by infected individuals
can contaminate surfaces and objects (WHO, July 9, 2020). Evidence
suggests that the virus that causes COVID-19 may remain viable on
surfaces for hours to days (Riddell et al., October 7, 2020; van
Doremalen et al., April 16, 2020; CDC, April 5, 2021b), depending on
the ambient environment and the type of surface (WHO, July 9, 2020).
Although fomites and contaminated surfaces are not a common
transmission mode of COVID-19, demonstration of surface contamination
and experiences with surface contamination linked to subsequent
infection transmission with other coronaviruses, have informed the
development of cleaning and situational
disinfection recommendations to mitigate the potential of fomite
transmission of COVID-19 (WHO, May 14, 2020; CDC, April 5, 2021d).
Cleaning of visibly dirty surfaces is a best practice measure for
prevention of COVID-19 and other viral respiratory illnesses in all
settings, including healthcare. Disinfection of these surfaces may be
appropriate if it is reasonable to assume that individuals with COVID-
19 may have been present. Cleaning and disinfection reduces the risk of
spreading infection by removing and killing germs on surfaces people
frequently touch, and in areas that were occupied or visited by a
person confirmed to have COVID-19 (CDC, April 5, 2021a; WHO, May 14,
2020; CDC, April 5, 2021c; CDC, April 5, 2021d).
Scientific evidence and guidelines from the CDC and WHO support
cleaning and situational disinfection of surfaces as an effective
practice to prevent the transmission of infectious viruses. Human
coronaviruses, including MERS coronavirus or endemic human
coronaviruses (HCoV), can be efficiently inactivated by surface
disinfection procedures (Kampf et al., February 6, 2020). A study of
124 Beijing households with one or more laboratory-confirmed COVID-19
positive family members demonstrated the efficacy of disinfection in
preventing the transmission of COVID-19. The study found that disease
transmission to family members was 77% less with use of chlorine- or
ethanol-based disinfectants every day compared to use of disinfectants
once in two or more days, irrespective of other protective measures
taken such as mask wearing and physical distancing (Wang et al., May
11, 2020).
The World Health Organization recommends thoroughly cleaning
environmental surfaces with water and detergent and applying commonly
used hospital-level disinfectants, such as sodium hypochlorite (i.e.,
the active ingredient in chlorine bleach), for effective cleaning and
disinfection (WHO, May 14, 2020). Surface disinfection with 0.1% sodium
hypochlorite or 62-71% ethanol significantly reduces coronavirus
infectivity on surfaces within 1 minute of exposure time (Kampf et al.,
February 6, 2020). The Environmental Protection Agency (EPA) has
compiled List N, a list of disinfectant products that can be used
against the virus that causes COVID-19, including ready-to-use sprays,
concentrates, and wipes (EPA, April 9, 2021). EPA includes products on
List N if they have demonstrated efficacy against the COVID-19 virus,
or a germ that is harder to kill than SARS-CoV-2 virus, or another
human coronavirus that is similar to the SARS-CoV-2 virus (EPA,
February 17, 2021).
III. Hand Hygiene
In all settings, including settings where regular cleaning may be
difficult, frequent hand washing and avoiding touching of the face
should be considered the primary prevention approach to mitigate COVID-
19 transmission associated with surface contamination (WHO, May 14,
2020). Hand hygiene is generally recognized as an effective
intervention at preventing respiratory illnesses and infectious disease
transmission (Rabie and Curtis, March 7, 2006; Haque, July 12, 2020;
Rundle et al., July 22, 2020). The CDC and the WHO have determined that
frequent handwashing, plus sanitization, are essential control measures
for COVID-19 prevention within the workplace, and HICPAC identifies
hand hygiene as an essential element of Standard Precautions (CDC, May
17, 2020; WHO, July 9, 2020; WHO, May 14, 2020; Siegel et al., 2007).
To prevent virus transmission, the CDC recommends that healthcare
workers engage in frequent handwashing with soap and water for at least
20 seconds, or use an alcohol-based hand sanitizer with at least 60%
alcohol (CDC, May 17, 2020). Alcohol-based hand sanitizers are the most
effective products for reducing the number of germs on the hands of
healthcare providers and are the preferred method for cleaning hands in
most clinical situations, while handwashing is necessary whenever hands
are visibly soiled (CDC, January 8, 2021). Handwashing with soap and
water mechanically removes pathogens (Burton et al., January 6, 2011),
and laboratory data demonstrates that hand sanitizers that contain at
least 60% alcohol are effective at killing the virus that causes COVID-
19 (Kratzel et al., July 2020; Siddharta et al., March 15, 2017).
Experience with work settings shows that flexible hand hygiene
approaches are effective to address unique scenarios in various work
environments. For example, handwashing is usually emphasized over hand
sanitizing, but CDC recommends the use of alcohol-based hand sanitizers
as the primary method for hand hygiene in most healthcare situations
(CDC, October 14, 2020). In healthcare settings, alcohol-based hand
sanitizers with 60-95% alcohol effectively reduce the number of
pathogens that may be present on the hands of healthcare providers,
particularly after interacting with patients (CDC, May 17, 2020). In
most clinical settings, unless hands are visibly soiled, an alcohol-
based hand rub is preferred over soap and water due to evidence of
better compliance compared to soap and water. However, CDC does
recommend healthcare workers wash their hands for at least 20 seconds
with soap and water when hands are visibly dirty, before eating, and
after using the restroom (CDC, May 17, 2020). Alcohol-based hand
sanitizers are also important as an alternative to soap and water for
workers who do not have ready access to handwashing facilities (e.g.,
emergency responders).
References
Burton, M. et al., (2011, January 6). The effect of handwashing with
water or soap on bacterial contamination of hands. International
Journal of Environmental Research and Public Health, 8(1), 97-104.
https://doi.org/10.3390/ijerph8010097. (Burton et al., January 6,
2011).
Centers for Disease Control and Prevention (CDC). (2020, May 17).
Hand hygiene recommendations: Guidance for healthcare providers
about hand hygiene and COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html. (CDC, May 17, 2020).
Centers for Disease Control and Prevention (CDC). (2020, October
14). Frequent questions about hand hygiene. https://www.cdc.gov/handwashing/faqs.html. (CDC, October 14, 2020).
Centers for Disease Control and Prevention (CDC). (2021, January 8).
Hand Hygiene in Healthcare Settings. https://www.cdc.gov/handhygiene/providers/index.html. (CDC, January 8, 2021).
Centers for Disease Control and Prevention (CDC) and Environmental
Protection Agency (EPA). (2021a, April 5). Reopening guidance for
cleaning and disinfecting public spaces, workplaces, businesses,
schools, and homes. https://www.cdc.gov/coronavirus/2019-ncov/community/reopen-guidance.html. (CDC, April 5, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, April 5).
Cleaning and disinfection for households: Interim recommendations
for U.S. households with suspected or confirmed COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cleaning-disinfection.html. (CDC, April 5, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, April 5).
Cleaning and disinfecting your facility. https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-facility.html.
(CDC, April 5, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, April 5).
Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for
Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html. (CDC,
April 5, 2021d).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Environmental Protection Agency (EPA). (2021, February 17). How does
EPA know that the products on List N work on SARS-CoV-2? https://www.epa.gov/coronavirus/how-does-epa-know-products-list-n-work-sars-cov-2. (EPA, February 17, 2021).
Environmental Protection Agency (EPA). (2021, April 9). List N tool:
COVID-19 disinfectants. https://cfpub.epa.gov/giwiz/disinfectants/index.cfm. (EPA, April 9, 2021).
Haque, M. (2020). Handwashing in averting infectious diseases:
Relevance to COVID-19. Journal of Population Therapeutics and
Clinical Pharmacology, 27(S Pt 1), e37-e52. https://doi.org/10.15586/jptcp.v27SP1.711. (Haque, July 12, 2020).
Honein, MA et al., (2020, December 11). Summary of Guidance for
Public Health Strategies to Address High Levels of Community
Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR
Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/10.15585/mmwr.mm6949e2. (Honein et al., December 11, 2020).
Kampf, G. et al., (2020). Persistence of coronaviruses on inanimate
surfaces and their inactivation with biocidal agents. The Journal of
Hospital Infection, 104(3), 246-251. https://doi.org/10.1016/j.jhin.2020.01.022. (Kampf et al., February 6, 2020).
Kratzel, A. et al., (2020, July). Inactivation of SARS-CoV-2 by
WHO--recommended hand rub formulations and alcohols. Emerging
Infectious Diseases, 26(7), 1592-1595. https://doi.org/10.3201/eid2607.200915. (Kratzel et al., July 2020).
Rabie, T. and Curtis, V. (2006). Handwashing and risk of respiratory
infections: A quantitative systematic review. Tropical Medicine &
International Health, 11(3), 258-267. https://doi.org/10.1111/j.1365-3156.2006.01568.x. (Rabie and Curtis, March 7, 2006).
Riddell, S. et al., (2020, October 7). The effect of temperature on
persistence of SARS-CoV-2 on common surfaces. Virology journal,
17(1), 145. https://doi.org/10.1186/s12985-020-01418-7. (Riddell et
al., October 7, 2020).
Rundle, C. et al., (2020, July 22). Hand hygiene during COVID-19:
Recommendations from the American Contact Dermatitis Society.
Journal of the American Academy of Dermatology, 83(6), 1730-1737.
https://doi.org/10.1016/j.jaad.2020.07.057. (Rundle et al., July 22,
2020).
Siddharta, A. et al., (2017, March 15). Virucidal activity of World
Health Organization--recommended formulations against enveloped
viruses, including Zika, Ebola, and Emerging Coronaviruses. The
Journal of Infectious Diseases, 215(6), 902-906. https://doi.org/10.1093/infdis/jix046. (Siddharta et al., March 15, 2017).
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).
van Doremalen, N. et al., (2020, April 16). Aerosol and surface
stability of SARS-CoV-2 as compared with SARS-CoV-1. The New England
Journal of Medicine, 382(16), 1564-1567. https://doi.org/10.1056/NEJMc2004973. (van Doremalen et al., April 16, 2020).
Wang, Y., Tian, H., Zhang, L., Zhang, M., Guo, D., Wu, W. (2020).
Reduction of secondary transmission of SAR-CoV-2 in households by
face mask use, disinfection and social distancing: A cohort study in
Beijing, China. BMJ Global Health, 5, e002794. doi: 10.1136/bmjgh-
2020-002794. (Wang et al., May 11, 2020).
World Health Organization (WHO). (2020, May 14). Coronavirus disease
2019 (COVID-19): Situation report, 115. https://apps.who.int/iris/handle/10665/332090. (WHO, May 14, 2020).
World Health Organization (WHO). (2020, July 9). Transmission of
SARS-CoV-2: Implications for infection prevention precautions.
https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO,
July 9, 2020).
L. Ventilation
Improving existing ventilation and ensuring optimal performance of
ventilation is an effective way to reduce viral transmission in
occupational populations. Work sites with existing heating,
ventilation, and air conditioning (HVAC) systems can utilize
improvements to, and maintenance of, high performance ventilation as
part of a layered response for infectious disease control. The
effectiveness of ventilation in controlling disease transmission is
based on scientific research and the recommendations of well-respected
occupational safety and health organizations, including government
agencies.
As explained in Grave Danger (Section IV.A. of the preamble), there
is evidence of airborne COVID-19 transmission within enclosed spaces
with inadequate ventilation. As a result, there is considerable support
for ensuring adequate ventilation through maintenance and improvements.
Federal agencies, international organizations, industry associations,
and scientific researchers agree that ensuring adequate ventilation is
important in reducing potential airborne transmission of COVID-19
(ASHRAE, April 14, 2020; Schoen, May 2020; WHO, May 10, 2020; AIHA,
September 9, 2020; CDC, May 7, 2021; CDC, April 7, 2021; CDC, March 23,
2021; Tang et al., August 7, 2020; Morawska et al., May 27, 2020).
In one scientific brief, the CDC provides a basic overview of how
ventilation can reduce the transmission of COVID-19 in indoor spaces.
Once respiratory droplets are exhaled, the CDC explains, they move
outward from the source and their concentration decreases through
fallout from the air (largest droplets first, smaller later) combined
with dilution of the remaining smaller droplets and particles into the
growing volume of air they encounter (CDC, May 7, 2021). Without
adequate ventilation, continued exhalation can lead to the amount of
infectious smaller droplets and particles produced by people with
COVID-19 to become concentrated enough in the air to spread the virus
to other people (CDC, May 13, 2021).
Ventilation controls the transmission of COVID-19 in two ways.
First, improving indoor ventilation by appropriately maximizing air
exchanges and by maintaining and improving heating, ventilation, and
air-conditioning (HVAC) systems can disperse and decrease the
concentration of COVID-19-containing small droplets and particles
suspended in the air. The lower the concentration, the less likely some
of those viral particles can be inhaled into an employee's lungs;
contact their eyes, nose, or mouth; or fall out of the air to
accumulate on surfaces. Protective ventilation practices and
interventions can reduce the airborne concentration, which reduces the
overall viral dose to occupants (CDC, March 23, 2021). Improved
ventilation can also significantly reduce the airborne time of
respiratory droplets (Somsen et al., May 27, 2020; CDC, March 23,
2021). As a result, the risk of transmission of COVID-19 indoors is
reduced, which makes workplaces safer (Schoen, May 2020; CDC, April 7,
2021; CDC, March 23, 2021; Honein et al., December 11, 2020).
Ventilation systems alone cannot completely prevent airborne
transmission (EPA, July 16, 2020; CDC, March 23, 2021), but are
particularly effective when implemented in conjunction with additional
control measures in a layered approach, including other engineering
controls and other protections required in this ETS.
Second, air filters in HVAC systems remove particles, including
aerosolized particles containing COVID-19, from
recirculated air streams before returning the air to workspaces.
Increased filter efficiency is a component of the HVAC system which can
be adjusted to reduce the risk of COVID-19 transmission (Schoen, May
2020; ASHRAE, April 14, 2020; CDC, May 7, 2021; CDC, March 8, 2021;
CDC, March 23, 2021; Morawska et al., May 27, 2020). Minimum Efficiency
Reporting Values (MERV) report a filter's ability to capture larger
particles between 0.3 and 10 microns ([micro]m). MERV ratings range
from 1 to 16, and a higher rating indicates a more efficient filter.
The virus that causes COVID-19 is approximately 0.125 [micro]m in
diameter; however, the virus is contained in infectious particles,
droplets, and droplet nuclei (dried respiratory droplets) that are
predominantly 1 [micro]m in size and larger.
The CDC recommends increasing filtration to the highest extent
possible that is compatible with the design of the HVAC system (CDC,
March 23, 2021). The American Society of Heating, Refrigeration, and
Air-Conditioning Engineers (ASHRAE) recommends using filters with a
MERV rating of at least 13, where feasible, or the highest level
compatible with the specified HVAC system, to help capture the
infectious aerosols containing COVID-19 (Schoen, May 2020; ASHRAE,
December 8, 2020). The use of filtration has also been supported by
others, including Mousavi et al., August 26, 2020. A MERV rating of 13
is at least 85-percent efficient at capturing particles from 1 [micro]m
to 3 [micro]m in size (Schoen, May 2020; CDC, March 8, 2021; CDC, March
23, 2021), which is the size of the particles carrying COVID-19. A
MERV-14 filter is at least 90% efficient at capturing particles of this
same size, and efficiencies for MERV-15 and MERV-16 filters are even
greater. As such, filters with MERV ratings of 13 or greater are much
more efficient at capturing particles of this size than a MERV 8 filter
(CDC, March 23, 2021).
The ability of HVAC systems to reduce the risk of exposure depends
on many factors, including design features, operation and maintenance
practices, and the quality and quantity of outdoor air supplied to the
space. The CDC has emphasized that building owners and operators should
ensure that ventilation systems are functioning properly and providing
acceptable levels of indoor air quality for the occupancy level of the
given space. Consultation with an HVAC professional will help ensure
that improvements to ventilation systems are implemented in accordance
with the capacity and design of the HVAC system, according to state and
local building codes and guidelines, and to avoid imbalances that could
negatively alter other indoor air quality parameters (e.g.,
temperature, humidity, moisture) (EPA, July 16, 2020; CDC, March 23,
2021).
The CDC has also recommended increasing airflow (CDC, March 23,
2021) to occupied spaces, if possible. One way to achieve this is by
opening windows and doors (Howard-Reed et al., February 2002; CDC,
March 23, 2021), where feasible and as weather conditions permit.
However, decisions to open windows and doors should be done after
evaluating other safety and health risks for occupants, such as risk of
falling or breathing outdoor environmental contaminants (e.g., carbon
monoxide, molds, and pollens) (CDC, April 7, 2021; CDC, March 8, 2021;
CDC, March 23, 2021). In order for this type of ventilation to serve as
an effective COVID-19 control, the air flow must be directed so that
contaminated air is not funneled through workspaces toward another
person.
Based on the best available evidence, the agency concludes that
implementation of improved ventilation and maintaining HVAC system
performance is an effective and necessary approach to reduce incidence
of COVID-19 both on its own and also when complemented by other
measures as part of a multi-layered strategy to minimize employee
exposure to the grave COVID-19 danger.
References
American Industrial Hygiene Association (AIHA). (2020, September 9).
Reducing the Risk of COVID-19 Using Engineering Controls: Guidance
Document. https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Guidance-Documents/Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9,
2020).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020, April 14). ASHRAE Position Document on
Infectious Aerosols. https://www.ashrae.org/file%20library/about/position%20documents/pd_infectiousaerosols_2020.pdf. (ASHRAE, April
14, 2020).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020, December 8). Debunking myths about MERV,
air filtration. https://www.ashrae.org/news/ashraejournal/debunking-myths-about-merv-air-filtration. (ASHRAE, December 8, 2020).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 23).
Ventilation. https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html. (CDC, March 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 7).
COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/office-buildings.html.
(CDC, April 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Environmental Protection Agency (EPA). (2020, July 16). Ventilation
and Coronavirus (COVID-19). https://www.epa.gov/coronavirus/ventilation-and-coronavirus-covid-19. (EPA, July 16, 2020).
Honein, MA et al., (2020, December 11). Summary of Guidance for
Public Health Strategies to Address High Levels of Community
Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR
Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/10.15585/mmwr.mm6949e2. (Honein et al., December 11, 2020).
Howard-Reed, C. et al., (2002, February). The effect of opening
windows on air change rates in two homes. Journal of Air and Waste
Management Association 52: 147-159. (Howard-Reed et al., February
2002).
Morawska, L. et al, (2020, May 27). How can airborne transmission of
COVID-19 indoors be minimized? Environmental International 142:
105832. https://doi.org/10.1016/j.envint.2020.105832. (Morawska et
al., May 27, 2020).
Mousavi, ES et al., (2020, August 26). COVID-19 Outbreak and
Hospital Air Quality: A Systematic Review of Evidence on Air
Filtration and Recirculation. Environmental Science and Technology.
acs.est.0c03247. https://doi.org/10.1021/acs.est.0c03247. (Mousavi
et al., August 26, 2020).
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COVID-19 pandemic. ASHRAE Journal. (Schoen, May 2020).
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ventilated spaces and SARS-CoV-2 transmission. The Lancet 8: 658-
659. https://doi.org/10.1016/. (Somsen et al., May 27, 2020).
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al., August 7, 2020).
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19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO,
May 10, 2020).
M. Health Screening and Medical Management
As discussed in more detail in Grave Danger (Section IV.A. of the
preamble), COVID-19 is a disease that is primarily transmitted from
person to person through respiratory droplets that are produced when
someone breaths, talks, sneezes, or coughs, and the droplets contact
the eyes, nose, or mouth of another person. It may also infrequently be
transmitted by someone touching a contaminated surface and then
touching their eyes, nose, or mouth. Consequently, to effectively
reduce the transmission of COVID-19 in the workplace, it is necessary
to have a medical management program that identifies and removes
infected or likely infected employees from the workplace, and notifies
employees about possible exposures to COVID-19 so they can take
appropriate steps to further reduce transmission.
I. Employee Screening
Regular health screening for possible indications of COVID-19 is a
first step in detecting employees who might be COVID-19-positive so
those employees can seek medical care or testing, or inform the
employer if they have certain symptoms. While pre-symptomatic and
asymptomatic infections and the non-specificity of COVID-19 symptoms
make it difficult to quantify the accuracy of symptom screening in
predicting COVID-19, health screening is a strategy supported by the
CDC and the American College of Occupational and Environmental Medicine
(ACOEM). ACOEM recommends that employers implement a medical
surveillance program that includes educating and training employees on
how to recognize when they may have COVID-19, in order to prevent
employees with infections from entering the workplace (ACOEM, August
19, 2020).
The CDC recommends that employers conduct screening at the
worksite, or train employees to be aware of and recognize the signs and
symptoms of COVID-19 and to follow CDC recommendations to self-screen
for symptoms before coming to work (CDC, March 8, 2021). Screening for
employee symptoms, particularly when combined with their recent
activities (e.g., the likelihood they have had a recent exposure to
COVID-19), can help determine if the employee is suspected to have
COVID-19 or should be tested. Testing can be useful in guiding the
treatment that employees receive for their illness as well as
triggering isolation to prevent exposure to others (NASEM, November 9,
2020). The FDA (March 11, 2021) has issued a number of emergency use
authorizations for COVID-19 tests that detect infections with the SARS-
CoV-2 virus. CDC recommends prompt COVID-19 testing of anyone who has
had a known exposure to someone with COVID-19, has had a possible
exposure to someone with COVID-19, or has symptoms of COVID-19, as a
strategy to reduce SARS-CoV-2 transmission (Honein et al., December 11,
2020). Based on medical advice and information provided by testing,
employees can learn if they are suspected or confirmed to have COVID-
19. The earlier employees learn whether they are infected, the more
likely that workplace exposures can be prevented.
As explained below, it is necessary that employees who are
suspected or confirmed to have COVID-19 be removed from the workplace
to prevent transmission to other employees. However, because COVID-19
symptoms are non-specific and common with other infectious and non-
infectious conditions, not all individuals experiencing these symptoms
will necessarily have COVID-19. Thus, Struyf et al., (2021) concluded
that using a single sign or symptom of COVID-19 will result in low
diagnostic accuracy and that combinations of symptoms increase
specificity while decreasing sensitivity (explained in further detail
below); however the authors also noted that studies are lacking on
diagnostic accuracy of combinations of signs and symptoms.
The success of a screening strategy in identifying whether an
employee has COVID-19 is based on two factors: Sensitivity and
specificity for identifying COVID-19. Sensitivity refers to the ability
of the symptom screening strategy to correctly identify persons who
have COVID-19. Specificity refers to the ability of the symptom
screening strategy to correctly identify persons who do not have COVID-
19. As an example, a systematic review and meta-analysis by Pang et
al., (2020) determined a sensitivity of 0.48 and specificity of 0.93
for smell disorders in identifying COVID-19. This means that under the
scenarios in which the studies were conducted, screening for smell
disorders would correctly identify around 48% of individuals who have
COVID-19 (sensitivity), and would correctly identify 93% of individuals
who do not have COVID-19 (specificity).
A number of studies have been conducted to determine common
symptoms associated with COVID-19, along with their sensitivity and
specificity. In addition to the Pang et al., (2020) study, there have
been several other studies strongly linking smell and taste disorders
as a symptom indicative of COVID-19. In a review of 18 studies of
COVID-19 patients, Printza and Constantidis (2020) reported that loss
of either smell or smell and taste was reported in most studies, and
that that symptom is more prevalent in COVID-19 patients than in
patients suffering from other respiratory infections. The report also
found that the loss of smell was more prevalent among patients with a
less severe case of COVID-19 disease. Four systematic reviews, three of
which included meta-analyses, reported that for smell or taste
disorders, sensitivity ranged from 0.41 to 0.65 and specificity ranged
from 0.90 to 0.93 (Pang et al., 2020; Printza and Constantidis, 2020;
Kim et al., 2021; Struyf et al., 2021).
A systematic review found that while loss of taste or smell is the
most specific symptom of COVID-19, the most commonly reported symptoms
of COVID-19 were fever, cough, fatigue, shortness of breath, and sputum
production (Alimohamadi et al., 2020). In another review of a
convenience sample (i.e., a non-randomly selected sample based on
availability, opportunity, or convenience) of COVID-19 patients in the
United States, 96% of patients reported having a fever, a cough, or
shortness of breath (Burke et al., 2020). The review also found that
68% of hospitalized patients experienced all three of those symptoms,
but only 31% of non-hospitalized patients reported all three symptoms.
A systematic review by Kim et al., (2021) determined sensitivity and
specificity, respectively, for fever (0.6, 0.55), cough (0.59, 0.39),
and difficulty breathing (0.18, 0.84).
Although not intended to identify individuals who could potentially
have COVID-19, and the diagnostic accuracy of the approach is not
known, the surveillance definition used by the Council of State and
Territorial Epidemiologists (CSTE) provides insight on an approach to
using symptoms to identify possible cases of COVID-19 in the absence of
a more likely determination by a healthcare provider. The CSTE
surveillance definition for COVID-19 includes: (1) At least two of
the following symptoms: Fever (measured or subjective), chills, rigors
(i.e., shivering), myalgia (i.e., muscle aches), headache, sore throat,
nausea or vomiting, diarrhea, fatigue, congestion or runny nose; or (2)
any one of the following symptoms: Cough, shortness of breath,
difficulty breathing, new olfactory (i.e., smell) disorder, new taste
disorder; or (3) severe respiratory illness with a least one of the
following: Clinical or radiographic evidence of pneumonia, acute
respiratory distress syndrome (ARDS) (CSTE, 2020).
Given the non-specificity of COVID-19 symptoms, consultation with a
licensed healthcare provider can provide more insight on the likelihood
that an employee with certain symptoms has COVID-19. A licensed
healthcare provider can elicit key clinical information, such as
timing, frequency, intensity, and other factors in diagnosing the
patient, after considering different medical explanations. A licensed
healthcare provider can also elicit additional clinical information
(e.g., pre-existing medical conditions), elicit epidemiologic
information (e.g., exposure to COVID-19, travel history, rates of
community transmission), and order laboratory testing to assist with
the diagnosis of COVID-19 and differentiation from other medical
conditions.
In general, the presence of COVID-19 symptoms can alert employees
that they may have COVID-19, which will allow them to take appropriate
next steps. Thus, by monitoring for COVID-19 symptoms through regular
health screening, employees can better address their personal health
and avoid potentially infecting other people by seeking medical
attention and getting tested for COVID-19 as appropriate; informing
their employer if they are suspected or confirmed to have COVID-19,
including concerning symptoms; and remaining away from the workplace
where appropriate. Therefore, health screening is an effective strategy
for preventing the transmission of COVID-19 in the workplace.
II. Employee Notification to Employer of COVID-19 Illness or Symptoms
Employers can reduce workplace exposures by preventing employees
who are, or could be, COVID-19 positive from entering the workplace and
transmitting the disease to others. But to do so, employers must be
aware that an employee is suspected or confirmed to have COVID-19 or is
symptomatic. The Summary and Explanation (Section VIII of the preamble)
includes more discussion of the precise criteria and rationale for when
an employee is required to notify an employer that they are suspected
or confirmed to have COVID-19 or are experiencing certain types of
symptoms. It is critical that employees make their employers aware
promptly after the employee is suspected or confirmed to have COVID-19
through test, medical diagnosis, or the specific symptoms of concern
discussed in the Summary and Explanation (Section VIII of the
preamble). With this information the employer can act to help prevent
transmission in the workplace.
III. Employer Notification to Employees of COVID-19 Exposure in the
Workplace
Notifying employees of a possible exposure to someone confirmed to
have COVID-19 is an important and effective intervention to reduce
transmission. Under the ETS, this includes any employee who was not
wearing a respirator and any other required PPE while in close contact
with the individual with COVID-19 or while working in the same physical
space around the same time as the individual with COVID-19 and
consequently may have had contact with that individual or touched a
contaminated surface. As the CDC has recognized, notification is
important because it allows for an exchange of information with the
person exposed to someone with COVID-19 and helps ensure that person
can pursue quarantine, timely testing, medical evaluation, and other
necessary support services (CDC, February 26, 2021). Notification also
acts as a complement to an employer's regular health screening program
by informing employees who may have been exposed to COVID-19 in the
workplace, so that they can appropriately assess and monitor their
health and report any symptoms that may develop to their employer. It
is also important for employers to notify other employers whose
employees may have had close contact or been in the same area as those
infected individuals while not wearing required PPE so those employers
can notify their employees.
The impact that notification of possible COVID-19 exposures can
have in reducing COVID-19 transmission was demonstrated in a study by
Kucharski et al., (2020), which found that when location-specific
contact tracing and notification was used to make decisions on
isolation and home quarantine, transmission of COVID-19 was reduced by
64% when contact tracing was performed manually and 47% when performed
by an app. However, the authors found that while notification is
effective in helping to decrease the spread of COVID-19 by making
individuals aware of potential infections, it is not a standalone
measure. Notification must be used in a layered approach in order to
create an effective infection control plan.
IV. Medical Removal From the Workplace
Employers can substantially reduce disease transmission in the
workplace by removing employees who are suspected or confirmed to have
COVID-19 based on a COVID-19 test or diagnosis by a healthcare
provider, or who have developed certain symptoms or combinations of
symptoms associated with COVID-19. Employers can also reduce the risk
of COVID-19 in the workplace by removing employees who are at risk of
developing COVID-19 because they were recently exposed to someone with
COVID-19 in the workplace. According to the CDC, a major mitigation
effort for COVID-19 is ``to reduce the rate at which someone infected
comes in contact with someone not infected. . . .'' (CDC, February 16,
2021b).
The ETS focuses on removing employees from the workplace, rather
than specifying requirements for quarantine or isolation that are
typically outside the control of the employer because they would occur
away from the workplace, but the concept of separating infected or
potentially infected individuals from others is the same. Both the CDC
and ACOEM endorse the use of isolation and quarantine as measures
needed to reduce this rate of contact and consequently slow the spread
of COVID-19. Isolation ensures that persons known or suspected to be
infected with the virus stay away from all healthy individuals.
Isolating contagious, or potentially contagious, employees from their
co-workers can prevent further spread at the workplace and safeguard
the health of other employees. Quarantine is used to keep persons at
risk of developing COVID-19 away from all other people until it can be
determined whether the individual is infected following an exposure to
someone with suspected or confirmed COVID-19 (Honein et al., 2020).
The first two categories of employees who should be removed from
the workplace are those employees who are suspected to be or are
confirmed to have COVID-19 based on a COVID-19 test or diagnosis by a
healthcare provider and those employees who develop certain
COVID-19 symptoms.\25\ Removal of these two categories of employees is
consistent with isolation guidance from the CDC (February 11, 2021).
Employers also prevent further transmission of COVID-19 in the
workplace by providing employees a place to isolate from other workers
until they can go home if they arrive with, or develop, COVID-19
symptoms at work (CDC, February 16, 2021a; CDC, March 8, 2021). ACOEM
(August 19, 2020) also recommends that symptomatic employees stay home
to protect healthy workers. 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 an R0 of 2.5 to an
R0 of 1.6. However, the study authors noted that when assuming low
levels of asymptomatic transmission the R0 never fell below one,
meaning there is a need for isolation to be used in concert with a more
robust and layered infection control program, as is required by other
provisions in the ETS.
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\25\ Evidence on the sensitivity and specificity of certain
symptom triggers is discussed above. The Summary and Explanation
(Section VIII of the preamble) includes more discussion of the
symptoms that trigger removal from the workplace and the rationale
for selection of those symptoms.
---------------------------------------------------------------------------
The third category of employees who should be removed from the
workplace to further reduce disease transmission are those who are at
risk of developing COVID-19 because they have had recent close contact
in the workplace with someone who is COVID-19-positive while not
wearing a respirator and all required PPE (CDC, March 12, 2021). The
need for removal of these employees is based on quarantine guidance
from CDC (December 2, 2020) and is consistent with CDC recommendations
for quarantine as a means of reducing workplace transmission (CDC,
February 16, 2021a). Such removal is important because infected
individuals are capable of transmitting the virus before they start
experiencing symptoms and are aware that they are ill, and many
(estimated to be 17% in one analysis) may never experience symptoms at
all (Byambasuren et al., December 11, 2020). Therefore, ensuring that
exposed employees are removed from work until it is unlikely that they
have developed COVID-19 is critical for preventing the transmission of
infections. CDC defines exposure through unprotected close contact as
being within 6 feet of an infected person for a cumulative total of at
least 15 minutes over a 24-hour period starting at 2 days before
illness onset (or 2 days before samples are collected for testing in
asymptomatic patients) and until the infected person meets the criteria
for ending isolation (CDC, March 1, 2021). The risk level of the
exposure depends on factors such as whether the healthcare provider was
wearing a facemask or respirator, if an AGP was being performed without
all recommended PPE, or if the patient had source control in place.
However, CDC does not recommend quarantine following close contact
with someone who is suspected or confirmed to have COVID-19, if the
person who had close contact meets all of the following criteria: (1)
They have been fully vaccinated for COVID-19; (2) it has been at least
2 weeks since the full vaccination was completed; and (3) they do not
develop any symptoms (CDC, May 13, 2021; CDC, March 12, 2021). CDC also
has analyzed accumulating evidence indicating that persons who have
recovered from laboratory-confirmed COVID-19 and remain symptom-free
may not have to quarantine again if exposed within three months of the
illness. CDC (March 16, 2021) concluded that although the evidence does
not definitively demonstrate the absence of reinfection within a three-
month period, the benefits of avoiding unnecessary quarantine likely
outweigh the risks of reinfection as long as other precautions such as
physical distancing, facemasks, and hygiene continue to be implemented.
CDC's recommendation was based on a review of more than 40 studies
examining evidence of re-infection in recovered individuals (complete
reference list included in CDC, (March 16, 2021). While many studies
demonstrated that reinfection can occur at least 90 days after
infection (e.g., Colson et al., 2020; Van Elslande et al., 2021), other
studies suggest re-infection is possible as early as 45 days after
infection (e.g., Abu-Raddad et al., 2020; Larson et al., 2020; Tillet
et. al., 2020). Although antibodies to the virus that causes COVID-19
have not been definitively correlated with protection from reinfection
and it is not clear what level of antibodies would be required for
protection, increasing numbers of studies are suggesting that the
majority of recovered patients develop antibodies specific for the
virus that causes COVID-19 (e.g., Deeks et al., 2020; Gudbjartsson et
al., 2020). Antibody responses have been reported to last for six
months or more in some studies (e.g., Choe et al., 2021; Dan et al.,
2021), but other studies suggested lower levels of antibodies or
detection of antibodies for shorter periods of time (e.g., Ibarrondo et
al., 2020; Seow et al., 2020). In addition to the production of
antibodies, immunity can be achieved through virus-specific T- and B-
cells (e.g., Kaneko et al., 2020), and some studies show that T- and B-
cell immunity can last for 6 months or more (e.g., Dan et al., 2021;
Hartley et al., 2020). Some studies suggest that T- and B-cell
responses could be higher in symptomatic versus asymptomatic adults
(e.g., Zuo et al., 2021). Results from animal challenge studies (e.g.,
Chandrashekar et al., 2020; Deng et al., 2020), and seropositive adults
in outbreak settings (Abu-Raddad et al., 2020; Lumley et al., 2021)
provide additional evidence that initial infection might protect
against reinfection.
In addition to the uncertainty noted above, CDC notes that risk of
reinfection may be increased in the future, with the circulation of
variants (e.g., CDC, March 16, 2021; Nonaka et al., 2021; Harrington et
al., 2021; Zucman et al., 2021). Because of the uncertainty regarding
reinfection and increased possibility of reinfection following exposure
to variants, the CDC recommends that employees be removed from the
workplace if they develop symptoms after close contact with someone who
has COVID-19, even if the employee is fully vaccinated or was confirmed
to have COVID-19 in the previous three months (CDC, May 13, 2021; CDC,
April 2, 2021).
V. Medical Removal Protection Benefits
Notification and removal will be most effective if the employees
responsible for reporting do not face potential financial hardships for
accurate reporting of symptoms and illnesses. As noted above, employers
must know that an employee is suspected or confirmed to have COVID-19
or has certain symptoms of COVID-19 before they can remove those
employees from the workplace. But removing employees from the workplace
based on their own reports is likely to prove an effective control for
COVID-19 only if the employees are not afraid they will be penalized
for making those reports. OSHA's experience demonstrates that employees
will self-report at a sufficient level to make removal program
effective only when removed employees do not face a significant
financial penalty--
such as lost income during the removal period--and when employees may
return to work after their removal period without any adverse action or
deprivation of rights or benefits because of the removal. Because the
employer will often have no other way to learn whether an employee is
suspected or confirmed to have COVID-19, or has certain symptoms of
COVID-19, medical removal protections are necessary to ensure that
employees are not disincentivized to report suspected or confirmed
COVID-19 or symptoms of COVID-19. Because infectious employees pose a
direct hazard to their co-workers, removing barriers to reporting
symptoms or confirmed diagnoses protects not only the reporting
employee but also every other employee who would otherwise be exposed
to infection.
OSHA's experience shows that the threat of lost earnings, benefits,
and/or seniority protection provides a significant disincentive for
employees to participate in workplace medical screening and reporting
programs (see United Steelworkers of America v. Marshall, 647 F.2d
1189, 1237 (D.C. Cir. 1981) (recognizing the importance of removing
financial disincentives for workers exposed to lead)). In the lead
rulemaking, OSHA adopted a medical removal protection benefits
provision in part due to evidence that employees were using chelating
agents to achieve a rapid, short-term reduction in blood lead levels
because they were desperate to avoid economic loss, despite the
possible hazard to their health from the use of chelating agents (43 FR
54354, 54446 (November 21, 1978)). OSHA's standards for cotton dust and
lead contain testimony from numerous employees indicating that workers
would be reluctant to report symptoms and participate in medical
surveillance if they fear economic consequences (43 FR at 54442-54443;
50 FR at 51154-51155). A major reason that OSHA included medical
removal protection benefits in the formaldehyde standard is because the
standard does not have a medical examination trigger, such as an action
level, but instead relies on annual medical questionnaires and employee
reports of signs and symptoms. Thus, the approach is completely
dependent on employee cooperation (57 FR at 22293). Literature reviews
have similarly reported that lack of compensation is one reason why
employees might go into work while sick (Heymann et al., 2020; Kniffen
et al., 2021). Based on this evidence, OSHA concludes that protection
of benefits for removed employees is necessary to maximize employee
reporting of suspected or confirmed COVID-19 and symptoms associated
with COVID-19. This in turn maximizes protection for all employees at
the workplace.
VI. Return to Work
After employees have been removed from the workplace as required by
this standard, the employer must ensure that they do not return to the
workplace until there is no longer a risk of disease transmission.
Scientific evidence is available to determine the appropriate duration
of isolation for COVID-19, which can be used to determine the
appropriate duration of removal from the workplace. As general
guidance, CDC recommends isolating symptomatic people with COVID-19 for
at least 10 to 20 days after symptom onset, dependent on factors such
as the severity of infection and health of the immune system. In most
cases, the CDC states that a person can end isolation when (i) 10 days
have passed since symptom onset; (ii) fever has been resolved (without
fever-reducing medications) for at least 24 hours; and (iii) other
symptoms (except loss of taste and smell) have improved. In cases of
severe illness, the decision to end isolation may require consultation
with an infection control expert. For persons who are confirmed
positive but never develop symptoms, CDC recommends ending isolation at
10 days after the first positive test (CDC, March 16, 2021). These
recommendations are based on scientific evidence reviewed by CDC which
suggest that levels of viral RNA in upper respiratory tract samples
begin decreasing after the onset of symptoms (CDC, March 16, 2021; CDC,
unpublished data, 2020, as cited in CDC, March 16, 2021; Midgley et
al., 2020; Young et al., 2020; Zou et al., 2020; W[ouml]lfel et al.,
2020; van Kampen et al., 2021). Levels of replication-competent viruses
(i.e., viruses that are able to infect cells and produce more
infectious viral particles) also decrease over time; with only two
possible exceptions, no replication-competent virus was detected after
10 days of symptom onset in individuals with mild-to-moderate disease
(CDC, unpublished data, 2020, as cited in CDC, March 16, 2021;
W[ouml]lfel et al., 2020; Arons et al., 2020; Bullard et al., 2020; Liu
et al., 2020a; Lu et al., 2020; personal communication with Young et
al., 2020, as cited in CDC, March 16, 2021; Korea CDC, May 19, 2020;
Quicke et al., 2020). In a study of persons with severe disease
(possibly complicated in some individuals by an immunocompromised
status), the median duration of shedding infectious virus was 8 days
after onset of symptoms, and the probability of shedding virus after 15
days was estimated at 5% or less (van Kampen et al., 2021). In severely
immunocompromised patients, ``sub-genomic virus RNA'' or replication
competent virus was detected beyond 20 days and as much as 143 days
after a positive virus test (e.g., Avanzato et al., 2020; Choi et al.,
2020). A large contact-tracing study found no evidence of infections in
individuals who had contact with infectious individuals in a household
or hospital when exposure occurred at least 6 days after illness onset
(Cheng et al., 2020). Accordingly, these studies support the CDC's
recommended isolation guidance (CDC, February 16, 2021a; CDC, February
18, 2021a; CDC, February 18, 2021b). However, as noted, CDC's
recommendations for isolation are broad guidance; the appropriate
duration for any given individual may differ depending on factors such
as disease severity or the health of the employee's immune system.
As a general rule, CDC does not recommend a testing strategy as a
means for determining when to end isolation, with the possible
exception of severely immunocompromised persons (CDC, March 16, 2021).
This is because tests to detect viral genetic material may yield
positive results after a person is no longer infectious. Except in a
very limited number of cases, studies have demonstrated that although
some individuals were observed to persistently shed virus (for up to 12
weeks), replication-competent virus has not been recovered at three
weeks past illness (Korea CDC, May 19, 2020; CDC, March 16, 2021; Li et
al., 2020; Xiao et al, 2020; Liu et al., 2020a; Quicke et al., 2020).
In addition, a study of 285 persons with persistent virus shedding,
including 126 who experienced recurrent symptoms, found no evidence
that any of the 790 contacts were infected from exposures to the people
with persistent virus shedding (Korea CDC, May 19, 2020; CDC, March 16,
2021).
On the other hand, testing conducted after onset of sensitive
symptoms associated with COVID-19 can identify individuals who are not
infected. Peak virus shedding has been reported to occur just before
and as symptoms are developing (Beeching et al., 2020; He et al.,
2020). Testing for COVID-19 soon after the onset of symptoms has been
estimated to result in a low false-negative rate of 10%, based on the
reported Polymerase Chain Reaction test sensitivity (Grassley et al.,
2020).
Return-to-work criteria for employees who are removed from the
workplace because they are at risk of developing COVID-19 after
exposure to someone with COVID-19 in the workplace, but have not yet
developed symptoms or tested positive themselves, are based on the
CDC's quarantine guidance. Based on available scientific evidence, the
CDC generally recommends a 14-day quarantine period for individuals who
have been exposed to a confirmed case of COVID-19 and are therefore at
risk of developing COVID-19 (CDC, December 2, 2020; CDC, March 12,
2021). The 14-day quarantine period is based on the conclusion that the
upper bound of the incubation period (the period between the point of
infection and symptom onset) for COVID-19 is 14 days, and that there is
a possibility that an unknowingly infected person can transmit the
disease if quarantine is discontinued before 14 days (CDC, December 2,
2020). The scientific community agrees that a 14-day quarantine period
is ideal. Linton et al., (2020) recommended a quarantine period of at
least 14 days, based on a mean incubation period of 5 days, with a
range of 2-14 days, in patients from and outside of Wuhan, China. Lauer
et al., (2020) concluded that the CDC recommendation to monitor for
symptoms for 14 days is supported by the evidence, including their
study of patients outside the Hubei province that reported a mean
incubation period of 5.1 days and symptom development within 11.5 days
in 97.5% of those who develop symptoms.
Although a 14-day quarantine is ideal and generally recommended,
the CDC has recognized that a shorter quarantine period may be less
burdensome and result in increased compliance. Therefore, the CDC
reviewed emerging scientific evidence to provide shorter quarantine
options that employers can consider if allowed by local public health
authorities (Oran and Topol, 2020; Johansson et al., 2020; Kucirka et
al., 2020; Clifford et al., 2020; Quilty et al., 2021; Wells et al.,
2021; Khader et al., 2020, as cited in CDC, December 2, 2020; Liu et
al., 2020b; Ng et al., 2021; Grijalva et al., 2020). One of those
options is testing for the virus at five days after exposure and ending
quarantine at seven days after exposure if results are negative.
Importantly, this option is only appropriate for individuals who do not
develop symptoms over the quarantine period (as such individuals should
instead be managed according to the CDC's isolation strategies). Based
on the evidence reviewed, CDC concluded that ending quarantine after a
negative test and seven days with no symptoms would result in a
residual transmission risk of about 5%, with an upper limit of about
12% (CDC, December 2, 2020).
VII. Conclusion
As demonstrated above, the best available evidence strongly
supports OSHA's conclusion that implementation of a comprehensive
medical management program which includes health screening;
notifications of potential exposures; removing employees who are COVID-
19 positive, suspected to be positive, have certain symptoms, or have
been exposed to a person with COVID-19 from the workplace until there
is no longer a risk of disease transmission; and protection of removed
employees' compensation, rights, and benefits are necessary measures to
reduce incidence of COVID-19 exposure in the workplace. Because the
virus that causes COVID-19 is spread through exposure to infected
individuals or surfaces contaminated by infected individuals, quickly
identifying and removing employees from the workplace who have
developed, likely developed, or are at heightened risk of developing
COVID-19 will allow employers to significantly reduce the spread of
COVID-19 in the workplace. The prompt identification and removal of
these employees can prevent transmission of the virus to others in the
workplace. In addition, medical removal protection provisions that
ensure compensation and protection of rights and benefits during
removal will encourage employees to report diagnoses of suspected or
confirmed-positive COVID-19 and symptoms. However, as noted above, some
employees with COVID-19 will not have symptoms, and testing to allow
employees to return to work after exposures to COVID-19 or experiencing
symptoms associated with COVID-19 will likely result in some false
negatives. Therefore, a medical management program should be
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to the grave danger of COVID-19.
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PMC7801729. (van Kampen et al., 2021).
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).
W[ouml]lfel, R. et al., (2020). Virological assessment of
hospitalized patients with COVID-2019. Nature. 2020 May; 581(7809):
465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum
in: Nature. 2020 Dec; 588(7839): E35. PMID: 32235945. (W[ouml]lfel
et al., 2020).
Xiao, F. et al., (2020). Infectious SARS-CoV-2 in Feces of Patient
with Severe COVID-19. Emerging Infectious Diseases. 2020 Aug; 26(8):
1920-1922. doi: 10.3201/eid2608.200681. Epub 2020 May 18. PMID:
32421494; PMCID: PMC7392466. (Xiao et al., 2020).
Young, BE. et al., (2020). Epidemiologic Features and Clinical
Course of Patients Infected With SARS-CoV-2 in Singapore. Journal of
the American Medical Association. 2020 Apr 21; 323(15): 1488-1494.
doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21; 323(15):
1510. PMID: 32125362; PMCID: PMC7054855. (Young et al., 2020).
Zou, L. et al., (2020). SARS-CoV-2 Viral Load in Upper Respiratory
Specimens of Infected Patients. New England Journal of Medicine.
2020 Mar 19; 382(12): 1177-1179. doi: 10.1056/NEJMc2001737. Epub
2020 Feb 19. PMID: 32074444; PMCID: PMC7121626. (Zou et al., 2020).
Zucman, N. et al., (2021). Severe reinfection with South African
SARS-CoV-2 variant 501Y.V2: A case report. Clinical Infectious
Diseases. 2021 Feb 10: ciab129. doi: 10.1093/cid/ciab129. Epub ahead
of print. PMID: 33566076; PMCID: PMC7929064. (Zucman et al., 2021).
Zuo, J. et al., (2021). Robust SARS-CoV-2-specific T cell immunity
is maintained at 6 months following primary infection. Nature
Immunology. 2021 Mar 5. doi: 10.1038/s41590-021-00902-8. Epub ahead
of print. PMID: 33674800. (Zuo et al., 2021).
N. Vaccination
Vaccines are an important tool to reduce the transmission of COVID-
19 in the workplace. A vaccine serves three critical functions: First,
it can reduce the likelihood that a vaccinated person will develop
COVID-19 after exposure to SARS-CoV-2; second, it can lessen the
symptoms and effects in cases where the vaccinated person does contract
COVID-19; and third, although the CDC still recommends source controls
for vaccinated healthcare workers, it also acknowledges a growing body
of evidence that vaccination can reduce the potential that a vaccinated
person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers
(CDC, April 12, 2021; CDC, April 27, 2021). Vaccination also serves an
important role in reducing health disparities in employees of certain
demographics, who may be especially vulnerable to severe health effects
or death from COVID-19 (Dooling et al., December 22, 2020). Below OSHA
provides a general explanation of the need for vaccination measures in
the ETS; however, a fuller explanation of the efficacy of existing
vaccines and their impact on the risk of COVID-19 infection and
transmission is discussed in Grave Danger (Section IV.A. of the
preamble).
OSHA has long recognized the importance of vaccinating employees
against preventable illnesses to which they may be exposed on the job.
The Bloodborne Pathogens standard, for example, requires the hepatitis
B vaccine be made available to any employees with occupational exposure
to blood and other potentially infectious materials, in order to reduce
the risk of hepatitis B infection and subsequent illness and death (56
FR 64004, 64152 (Dec. 6, 1991)). A number of professional health
organizations have similarly long recognized the importance of
vaccinating employees to prevent illness. This is particularly true in
healthcare industries, where employees are more regularly at risk of
occupational exposure to transmissible diseases. For example, the
Advisory Committee on Immunization Practices (ACIP), which reviews
evidence of risk and vaccine effectiveness, recommends vaccinating
healthcare employees against numerous diseases, including influenza,
another viral disease spread through droplet transmission (Shefer et
al., November 25, 2011). Similarly, both HICPAC and the American
Hospital Association have encouraged and endorsed vaccination programs
or policies for healthcare workers. CDC, WHO, and the National
Academies of Science, among others, have all acknowledged that broad
vaccination of all people for COVID-19, in combination with other
public health measures, is a critical tool that can be used to address
the pandemic (CDC, April 29, 2021; WHO, January 8, 2021; NASEM, 2020).
Any vaccines offered to employees must be demonstrated to be safe
and effective. Fortunately, over the course of the pandemic, there have
been extensive efforts to develop COVID-19 vaccines. As discussed in
greater detail in Grave Danger (Section IV.A. of the preamble), there
are presently three COVID-19 vaccines authorized for emergency use by
the FDA in the United States: the Pfizer-BioNTech COVID-19 vaccine, the
Moderna COVID-19 vaccine, and the Janssen Biotech, Inc. Johnson and
Johnson COVID-19 vaccine, each recommended for use by ACIP in persons
at least 12 years of age and older for the Pfizer-BioNTech vaccines or
18 years of age and older for the Moderna and Johnson and Johnson
(Janssen) vaccines (Oliver et al., December 18, 2020; Oliver et al.,
January 1, 2021; FDA, April 9, 2021; FDA, April 1, 2021; FDA, February
26, 2021; FDA, May 10, 2021). In determining whether to grant EUA for a
new COVID-19 vaccine, the FDA considers several statutory criteria
provided in section 564 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3). In evaluating an EUA request, FDA considers, among
other things, the totality of scientific evidence available to
determine if it is reasonable to believe that the vaccine may be
effective (i.e., an efficacy of at least 50%) in preventing COVID-19
and that the known and potential benefits of the vaccine, when used to
prevent COVID-19, outweigh the known and potential risks of the vaccine
(FDA, April 9, 2021; FDA, April 1, 2021; FDA, February 26, 2021). The
product manufacturer must also demonstrate quality and consistency in
manufacturing. Accordingly, any COVID-19 vaccine that receives an EUA
from the FDA--including the Pfizer-BioNTech vaccine, Moderna vaccine,
the Johnson and Johnson (Janssen) vaccine, and any future vaccine that
receives such an authorization after the issuance of this ETS--has been
shown to be sufficiently safe and effective.
All three vaccines that have been authorized to date, including the
Pfizer-BioNTech, Moderna, and Johnson & Johnson (Janssen) vaccines,
have been found to be highly effective for the appropriate ages (Oliver
et al., December 18, 2020; Oliver et al., January 1, 2021; Polack et
al., December 31, 2020; FDA, December 17, 2020; FDA, December 10, 2020;
FDA, February 26, 2021). The vaccines were also found to be effective
in preventing disease that is severe or requires hospitalization. The
evidence
available at this time, however, does not yet establish that the
vaccines eliminate the potential for asymptomatic COVID-19 development;
rather, fully vaccinated people are less likely to have asymptomatic
infection or transmit SARS-CoV-2 to others (CDC, May 14, 2021). All
three authorized vaccines have met the authorization standard for
safety, with the majority of adverse effects observed to be mild or
moderate in severity and transient, including: fatigue; headache;
chills; muscle pain; joint pain; lymphadenopathy (swelling or
enlargement of lymph nodes) on the same side as the injection; and
injection site pain, redness, and swelling (CDC, December 13, 2020;
CDC, December 20, 2020; CDC, May 14, 2021; Oliver et al., December 18,
2020; Oliver et al., January 1, 2021; Polack et al., December 31, 2020;
FDA, December 17, 2020; FDA, December 10, 2020; FDA, February 26,
2021).
Further, as discussed more extensively in the Summary and
Explanation (Section VIII of the preamble) requirement for paid time
off for vaccination, vaccination can only function as an effective
control if workers have access to it. Additional explanation of the
importance of removing barriers to controls is also discussed in
Summary and Explanation (see discussion of requirements that employees
receive protections of the ETS at no cost, as well as requirements for
paid time off for vaccination, both in Section VIII of the preamble).
Vaccination References
Centers for Disease Control and Prevention (CDC). (2020, December
13). Local reactions, systemic reactions, adverse events, and
serious adverse events: Pfizer-BioNTech COVID-19 vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html. (CDC, December 13, 2020).
Centers for Disease Control and Prevention (CDC). (2020, December
20). Local reactions, systemic reactions, adverse events, and
serious adverse events: Moderna COVID-19 vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html. (CDC, December 20, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 12).
Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. (CDC, April
12, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 27).
Updated Healthcare Infection Prevention and Control Recommendations
in Response to COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html.
(CDC, April 27, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 29).
FAQ ``Why would a vaccine be needed when we can do other things . .
.?. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
(CDC, April 29, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 14).
Interim clinical considerations for use of COVID-19 vaccines
currently authorized in the United States. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fpfizer%2Fclinical-consideratio%E2%80%A6. (CDC, May 14, 2021).
Dooling, K et al., (2020, December 22). The Advisory Committee on
Immunization Practices' updated interim recommendation for
allocation of COVID-19 vaccine--United States, December 2020. MMWR
Rep 2021; 69: 1657-1660. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e2. (Dooling et al., December 22, 2020).
Food and Drug Administration (FDA). (2020, December 10). FDA
briefing document. Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/media/144245/download. (FDA, December 10, 2020).
Food and Drug Administration (FDA). (2020, December 17). MRNA-1273
sponsor briefing document (Moderna). https://www.fda.gov/media/144453/download. (FDA, December 17, 2020).
Food and Drug Administration (FDA). (2021, February 26). FDA
Briefing Document: Janssen Ad.COV2.S Vaccine for the Prevention of
COVID-19. (FDA, February 26, 2021)
Food and Drug Administration (FDA). (2021, April 1). Moderna COVID-
19 vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA,
April 1, 2021).
Food and Drug Administration (FDA). (2021, April 9). Pfizer-BioNTech
COVID-19 vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, April 9, 2021).
Food and Drug Administration (FDA). (2021, May 10). Pfizer-BioNTech
COVID-19 vaccine EUA Letter of Authorization Reissued. https://www.fda.gov/media/144412/download. (FDA, May 10, 2021).
National Academy of Sciences, Engineering, and Medicine (NASEM).
(2020). Framework for equitable allocation of COVID-19 vaccine.
https://www.nap.edu/download/25917. (NASEM, 2020).
Oliver, S et al., (2020, December 18). The Advisory Committee on
Immunization Practices' interim recommendation for use of Pfizer-
BioNTech COVID-19 vaccine--United States, December 2020. MMWR Rep
2020; 69: 1922-1924. DOI: http://dx.doi.org/10.15585/mmwr.mm6950e2.
(Oliver et al., December 18, 2020).
Oliver, S et al., (2020, December 20). The Advisory Committee on
Immunization Practices' interim recommendation for use of Moderna
COVID-19 vaccine--United States, December 2020. MMWR Rep 2021; 69:
1653-1656. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e1. (Oliver
et al., January 1, 2021).
Polack, F et al., (2020). Safety and efficacy of the BNT162b2 mRNA
Covid-19 vaccine. New England Journal of Medicine, 383(27), 2603-
2615. doi: 10.1056/nejmoa2034577. (Polack et al., December 31,
2020).
Shefer, A. et al., (2011, November 25). Immunization of health-care
personnel: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR Recommendations and Reports 60(RR07); 1-45.
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm. (Shefer et
al., November 25, 2011).
World Health Organization (WHO). (2021, January 8). COVID-19
vaccine. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines. (WHO, January 8, 2021).
O. Training
The CDC has determined that training is a necessary component of a
comprehensive control plan for COVID-19. The WHO has also determined
that training is an important control strategy for COVID-19 (WHO, May
10, 2020). When providing guidance for employers, the CDC has said that
employees need to be educated on steps they can take to protect
themselves from potential COVID-19 exposures at work. Employers
informing employees of the hazards to which employees may be exposed
while working is a cornerstone of occupational health and safety (OSHA,
2017). Employees play a particularly important role in reducing
exposures because appropriate application of work practices and
controls limit exposure levels. Employees therefore need to be informed
of the grave danger of COVID-19, as well as the workplace measures
included in their employers' COVID-19 plans because those measures are
necessary to reduce risk and provide protection to employees. Employees
must know what protective measures are being utilized and be trained in
their use so that those measures can be effectively implemented.
Training has been shown to be an effective tool to reduce injury
and illness (Burke et al., February 2006), but training is even more
critical when the workplace hazard includes the potential transmission
of the potentially deadly SARS-CoV-2 virus from one employee to
another: One improperly trained employee could increase risk for that
employee and for all of that employee's contacts, including coworkers.
Therefore, training is an essential component of a layered approach to
minimizing the risk of contracting COVID-19 in the workplace.
Training and education provide employees and managers an increased
understanding of existing safety and health programs. A thorough
understanding of these programs is necessary so employees can more
effectively contribute to their development and implementation.
Training provides employers, managers, supervisors, and employees with
the knowledge and skills needed to do their work safely and to avoid
creating hazards that could place themselves or others at risk, as well
as awareness and understanding of workplace hazards and how to
identify, report, and control them. Specialized training can address
unique hazards.
Because OSHA has long recognized the importance of training in
ensuring employee safety and health, many OSHA standards require
employers to train employees (e.g., the Bloodborne Pathogen standard at
29 CFR 1910.1030(g)(2)). When required as a part of OSHA standards,
such as is required by this ETS, training helps to ensure that
employees are able to conduct work in a safe and healthful manner
(OSHA, April 28, 2010). Training is essential to ensure that both
employers and employees understand the sources of potential exposure to
COVID-19 and control measures to reduce exposure to the hazard.
Employee comprehension is critical to ensuring that training is an
effective control. If training information is not presented in a way
that all employees understand, the training will not be effective.
Employers must thus consider language, literacy, and social and
cultural appropriateness when designing and implementing training
programs for employees (O'Connor et al., 2014). Additionally, if
employers do not offer training to employees in a convenient manner,
employees may be less likely to participate in the training. Therefore,
to be effective, training must be offered during scheduled work times
and at no cost to the employee. This will ensure that all employees
will have the time and financial resources to receive training. This is
also consistent with other OSHA standards. For example, the Bloodborne
Pathogen standard requires training be provided at no cost and during
working hours (Sec. 1910.1030(g)(2)(i)) and in a manner employees
understand (Sec. 1910.1030(g)(2)(vi)).
Research dating back to the 1980s has found ``overwhelming
evidence'' of the effectiveness of training programs on employee
knowledge (NIOSH, 1998), as well as employee behaviors (NIOSH, January
2010). With enhanced knowledge of safety and health hazards and
controls, employees can implement safer work practices. This can result
in reductions in workplace-related illnesses (Burke et al., February
2006).
The CDC has stated that information on workplace policies should be
communicated clearly, frequently, and via multiple messages (CDC, March
8, 2021). Training and education on safe work practices and controls
should be used to raise awareness among employees. Emphasizing the
effectiveness of these workplace controls helps to counteract
misinformation. Additional training, such as on PPE and infection
control policies and procedures, should be given to employees in those
workplaces where there is a high risk of exposure to COVID-19 (WHO, May
10, 2020).
Scientific research and case studies have further reinforced the
importance of training in responding to the COVID-19 pandemic.
Researchers found that a COVID-19 outbreak was effectively contained as
a result of prompt implementation of infection control measures,
including early in-person education of employees on the signs,
symptoms, and transmission of COVID-19 (Hale and Dayot, August 13,
2020). Knowledge of PPE was markedly improved following training on PPE
for healthcare employees in China during the COVID-19 pandemic (Tan et
al., June, 2020).
Training has been widely recognized as a key component of
occupational safety and health. Even though the body of scientific
evidence on the importance of training during the COVID-19 pandemic is
limited given its ongoing nature, the evidence that does exist only
further emphasizes the important role of training in protecting the
health and safety of employees. As such, OSHA has concluded that
training is necessary to ensure proper implementation of the employer's
COVID-19 plan and all other control measures, and that such training
will reduce incidence of COVID-19 illness both on its own and when
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to the grave COVID-19 danger.
References
Burke, M.J. et al., (2006, February). Relative effectiveness of
worker safety and health training methods. American Journal of
Public Health 96: 315-324. (Burke et al., February 2006).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in
Hospital Food Service Workers. American Journal of Infectection
Control. S0196-6553(20)30777-X. https://doi.org/10.1016/j.ajic.2020.08.011. (Hale and Dayot, August 13,2020).
National Institute for Occupational Safety and Health (NIOSH).
(1998, June). Assessing Occupational Safety and Health Training: A
literature review, June 1998. https://www.cdc.gov/niosh/docs/98-145/pdfs/98-145.pdf?id=10.26616/NIOSHPUB98145. (NIOSH, June 1998).
National Institute for Occupational Safety and Health (NIOSH) (2010,
January). A systematic review of the effectiveness of training and
education for the protection of workers, January 2010.https://
www.cdc.gov/niosh/docs/2010-127/pdfs/2010-127.pdf. (NIOSH, January
2010).
O'Connor, T. et al., (2014). Occupational safety and health
education and training for underserved populations. New
Solutions24(1): 83-106. (O'Connor et al., 2014).
Occupational Safety and Health Administration (OSHA). (2010, April
28). Training Standards Policy Statement. https://www.osha.gov/dep/standards-policy-statement-memo-04-28-10.html.(OSHA, April 28,
2010).
Occupational Safety and Health Administration (OSHA). (2017).
Workers' Rights. https://www.osha.gov/sites/default/files/publications/osha3021.pdf.(OSHA, 2017).
Tan, W. et al., (2020, June). Whole-process emergency training of
personal protective equipment helps healthcare workers against
COVID-19: Design and effect. Journal of Occupational and
Environmental Medicine 62: 420-423. DOI: 10.1097/
JOM.0000000000001877. (Tan et al., June, 2020).
World Health Organization(WHO).(2020, May 10). Considerations for
public health and social measures in the workplace context of COVID-
19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19.(WHO,
May 10, 2020).
VI. Feasibility
A. Technological Feasibility
This section presents an overview of the technological feasibility
assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19.
The ETS has four sections: Healthcare (29 CFR 1910.502); Mini
Respiratory Protection Program (29 CFR 1910.504); Severability (29 CFR
1910.505); and Incorporation by
Reference (29 CFR 1910.509). The ETS applies to all settings where any
employee provides healthcare services or performs healthcare support
services. The settings covered by the ETS are listed in Table VI.A.-1.
[GRAPHIC] [TIFF OMITTED] TR21JN21.001
The mini respiratory protection program section supplements the ETS
to provide additional protection to workers in appropriate cases. The
healthcare and mini respiratory protection program sections of the ETS
will be discussed below. It is not necessary to discuss the
severability or incorporation by reference sections, as those sections
do not by their own terms impose any requirements that raise issues of
technological feasibility.
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 (3rd 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's assessment focuses on the controls required by the ETS that
stakeholders may believe raise issues of technological feasibility.
These controls include the implementation of a COVID-19 plan and
healthcare-specific good infection control practices, as well the
following controls: Physical distancing; physical barriers; and
ventilation.\26\ As discussed below, OSHA's finding of technological
feasibility is supported by a large number of COVID-19 transmission
prevention plans and best practice documents it reviewed, as well as
physical distancing scenarios and a job matrix it developed, across the
healthcare sector.
---------------------------------------------------------------------------
\26\ As will be discussed later in this assessment, there are no
technological feasibility barriers related to compliance with other
requirements in the ETS (e.g., facemasks, respirators, cleaning and
disinfection, health screening and medical management, employee
notification).
---------------------------------------------------------------------------
While OSHA focuses on certain types of evidence in specific parts
of the analysis, much of the evidence supports other discrete findings
made by OSHA. Thus, for example, while OSHA focuses on its review of
plans and best practice documents in establishing the feasibility of
developing and implementing a COVID-19 plan, that evidence also
supports the feasibility of implementing healthcare-specific good
infection control practices, physical distancing and physical barriers,
and ventilation.
In addition, this analysis discusses only a few examples of the
plans and best practice documents it reviewed, does not recount every
element of the
plans and best practice documents that it reviewed, and does not
recount all details of the scenarios and job matrix it developed. OSHA
based its technological feasibility assessment on all the evidence in
the docket, and not just the select portions discussed here. The
discussion below is merely illustrative of the full complement of
evidence reviewed to demonstrate that employers have implemented the
controls required by the ETS.
Finally, OSHA's finding of technological feasibility should not be
read to indicate that individual plans or best practice documents OSHA
reviewed are ETS-compliant, that lack of inclusion of a control in a
plan or document indicates the control is infeasible, that the use of a
barrier by employers in a given situation indicates that physical
distancing was not feasible in that situation, or that a particular
control used (e.g., a plastic sheet or curtain used as a physical
barrier) is compliant with the ETS's requirements. The plans and best
practice documents are intended to show two things: (1) That developing
plans to address COVID-19 in various workplaces is both common and
feasible, and (2) that the controls required by the ETS have been
implemented and are feasible in the healthcare settings. The specifics
of the plans may vary, but the ETS COVID-19 plan requirements are
written as performance requirements that provide sufficient flexibility
to ensure that it is feasible for employers to develop and implement
such a plan, including appropriate controls, for any given healthcare
workplace.
I. The ETS's Approach to Employee Protection
The ETS generally includes provisions that are based on and in
accordance with applicable CDC and other well-established guidelines
for good infection control practices relevant to the exposures
encountered by employees during their job tasks. For example, the ETS
requires the employer to develop and implement policies and procedures
to adhere to Standard and Transmission-Based Precautions. As discussed
in detail in the Need for Specific Provisions (Section V of the
preamble, these requirements are consistent with well-established CDC
and other guidelines that are routinely followed by employers subject
to the ETS. That the ETS is based on CDC and other guidelines or
practices that are well established and have been routinely followed by
many employers both before and during the pandemic is compelling
evidence supporting OSHA's finding of technological feasibility.
Moreover, as described in more detail in the Need for Specific
Provisions (Section V of the preamble), COVID-19 transmission control
practices work best when used together, overlapping their protective
impact. To this end, the COVID-19 ETS provides a multilayered approach
in which a combination of control measures must be implemented to
minimize the risks of exposure to COVID-19. Thus, to effectively reduce
the risk, employers must ensure that they follow all requirements of
the ETS that are feasible. As discussed in the Need for Specific
Provisions (Section V of the preamble), the OSHA regulatory text
reflects a multilayered strategy by requiring employers to implement
multiple mitigation strategies with several layers of controls to lower
the risks of exposure and reduce the spread of disease. Utilizing
overlapping controls in a layered approach better ensures that no
inherent weakness in any one approach results in an infection incident.
OSHA emphasizes that the infection control practices required by the
ETS work best when used together, layering their protective impact
(Garner, 1996; Rusnak et al., September 2004; Miller et al., 2012; WHO,
2016). For example, in addition to requiring employers to ensure that
employees engage in physical distancing, wear facemasks and follow
healthy hand hygiene practices, employers must ensure the use of
physical barriers at fixed work locations outside of direct patient
care areas where 6 feet of physical distancing is not feasible and
ensure adequate building ventilation. No one measure can prevent
transmission by itself, but several layers combined can significantly
reduce the overall risk of COVID-19 transmission (e.g., a facemask
alone will not be enough to prevent the spread of COVID-19 without
physical distancing and other controls (Akhtar et al., December 22,
2020)).
Implementing multiple mitigation strategies is even more necessary
to reduce the risk, because it will not be feasible to apply every
control in every workplace situation. Thus, the ETS employs strategies
to ensure that employees will be protected even when a particular
control is not feasible. As discussed below, OSHA concludes that this
multilayered approach to employee protection is feasible based on its
review of commonly implemented healthcare-specific good infection
control practices contained in nationally recognized infection control
practices like CDC guidelines, employer plans, best practice documents,
scenarios, and a job matrix that show these precautions are already in
place or can be readily implemented by typical firms in the healthcare
sector.
OSHA emphasizes, finally, that although the ETS takes a
multilayered approach to employee protection, it also establishes how
and when controls must be used. For example, physical barriers are
required only where physical distancing is not feasible because, as
OSHA discusses in depth in Need for Specific Provisions (Section V of
the preamble), physical barriers work by preventing droplets from
traveling from the source (i.e., an infected person) to an employee,
and are particularly critical when physical distancing of 6 feet is not
feasible because most COVID-19 transmission occurs via respiratory
droplets that are spread from an infected individual during close
(within 6 feet) person-to-person interactions.
a. COVID-19 Plans
Paragraph (c) of the ETS requires the employer to develop and
implement a COVID-19 plan that includes policies and procedures to
minimize the risk of transmission of COVID-19, as reflected in
paragraphs (d) through (n) in the ETS. These provisions are summarized
in Table VI.A.-2 below, and are discussed in detail in Need for
Specific Provisions and Summary and Explanation (Sections V and VIII of
the preamble, respectively).
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OSHA conducted a search for existing COVID-19 plans and best
practices developed by employers, trade associations, and other
organizations and posted on their publicly available websites. OSHA's
search revealed 77 plans and best practice documents from companies and
trade associations in the Health Care and Social Assistance industry
sector that address COVID-19 hazards using the multilayered approach
and controls required by the ETS. To the extent individual plans are
not discussed specifically below, a breakdown with the name of the
company or organization, a description of the contents, and a link to
the plan can be found in the COVID-19 Plans by NAICS spreadsheet (ERG,
February 9, 2021).
Based on its review of these plans, OSHA concludes that it is
feasible for employers in typical firms in the healthcare sector to
comply with the requirements in the ETS for a COVID-19 plan.\27\ Below,
OSHA highlights the elements of a few of the plans and best practice
documents it reviewed. In each case, OSHA presumes that an organization
believes that the particular approaches contained in the organization's
own documents are technologically feasible.
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\27\ As stated, OSHA located 77 plans in the Health Care and
Social Assistance industry sector. Some of these plans do not
address protections that are covered by the ETS (i.e., they do not
cover settings where any employee provides healthcare services or
healthcare support services). OSHA relied on these particular plans
to draw its conclusion that it is feasible for employers in typical
firms in the healthcare sector to comply with the requirements in
the ETS for a COVID-19 plan, but only to the extent they address the
implementation of controls to protect workers in job categories
commonly found in workplaces where healthcare services and
healthcare support services are provided (e.g., public facing
employees, general office workers).
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ETS Workplace-Specific Hazard Assessments Required by Different
Healthcare Organizations
Paragraph (c)(4)(i) of the ETS requires healthcare employers to
conduct a workplace-specific hazard assessment to identify potential
workplace hazards related to COVID-19. The workplace-specific hazard
assessment requirements are discussed in detail in Need for Specific
Provisions and Summary and Explanation (Sections V and VIII of the
preamble, respectively).
OSHA conducted a search for existing COVID-19 plans and best
practices developed by employers, trade associations, and other
organizations and posted on their publicly available websites and found
that many required employers to conduct a workplace hazard assessment
to determine the COVID-19 exposure risks to employees. While the
specifics of the assessments may not mirror the full requirements for
OSHA's COVID-19 plans, those hazard assessments indicate and provide
additional support for OSHA's determination that it is feasible for
healthcare employers to design and implement COVID-19 plans. The best
practices also indicate that it is feasible for healthcare employers to
have policies and procedures to regularly check on the proper
implementation of
controls, which corresponds to OSHA's requirement that employers
regularly re-assess the COVID-19 plan to ensure that it is updated and
useful.
The Santa Clara Valley Medical Center (SCVMC) is a 574-bed acute
care, fully accredited public teaching hospital affiliated with
Stanford University Medical School and provides a full range of
inpatient, emergency rehabilitation, neonatal, intensive care, high-
risk maternity care, psychiatry, pediatric intensive care, and burn
intensive care services. The ambulatory outpatient services include
both primary and specialty clinics located not only at SCVMC, but also
at satellite facilities located throughout the area (SCVMC, December 1,
2020).
The SCVMC plans reviewed includes guidelines for COVID-19 exposure
and risk assessment, contact tracing, testing, and return to work for
their employees (SCVMC, December 1, 2020). Furthermore, the COVID-19
plan includes a policy outlining the worker exposure evaluation process
to be conducted by each department and each ambulatory care clinic that
is part of the SCVMC network. The assessment of exposure risk is
required for all individuals working in the SCVMC hospitals and clinics
including employees, volunteer, staff, physicians, contract personnel,
or other workers. The assessment required by the COVID-19 plan should
evaluate physical distancing, period or duration of exposure, as well
as the implementation of controls such as facemasks and respiratory
protection, and other PPE necessary to protect employees from COVID-19
exposure.
OSHA also reviewed the COVID-19 plan for Michigan Medicine, one of
the largest fully accredited academic medical centers in Michigan made
up of the University of Michigan health system and medical school. The
Michigan Medicine COVID-19 plan includes specific requirements for each
department to conduct employee COVID-19 job hazard assessments to
evaluate and mitigate the risk of COVID-19 for University of Michigan
workers (Michigan Medicine U-M, May 18, 2021).
The U-M COVID-19 plan also requires each department to create a
departmental specific COVID-19 work plan for its area to document their
COVID-19 employee job hazard assessment and plan. The plan also
provides departments with resources to develop and implement the
required COVID-19 employee job hazard assessment as well as a
departmental COVID-19 work plan including blank templates for both. The
hazard assessment and subsequent plan required by each department must
evaluate and address for each employee, the ability to maintain
physical distance from all other persons, employee requirements for
facemasks, respiratory protection, and other PPE, hand hygiene and
respiratory etiquette, workplace cleaning and disinfection within the
department or unit. The requirements of the job hazard assessment cover
employees, vendors, contractors, and all other workers performing task
in the department.
Additionally, OSHA reviewed the COVID-19 plan of Johns Hopkins
Medicine, which is made up of the Johns Hopkins University Health
System with six academic and community hospitals, four suburban health
care and surgery centers, over 40 patient care locations, and a home
care group that offers an array of health care services. The Johns
Hopkins Medicine COVID-19 plan includes requirements that assess the
COVID-19 transmission hazards in the workplace to determine the proper
implementation of controls (Johns Hopkins Medicine, 2021). The plan
also includes policies and procedures to implement a daily COVID-19
safety audit program. Each day, the COVID-19 safety auditor ensures
every hospital, outpatient clinic and care center is practicing proper
masking, physical distancing, handwashing and disinfection of
frequently touched surfaces. As with the SCVMC example, this supports
the feasibility of regular reassessments that employers will need to
conduct for their COVID-19 plans.
Based on its review of these plans, OSHA concludes that it is
feasible for employers in typical firms in the healthcare sector to
comply with the requirements in the ETS for a COVID-19 workplace-
specific hazard assessment.
ETS Controls Are Included in Best Practices Recommended by Healthcare
Professional Associations
Some of OSHA's evidence that the COVID-19 plan, distancing,
barriers, and ventilation modifications are feasible for healthcare
employers is that such measures, or substantially similar measures, are
already recommended by some of the largest professional associations in
the healthcare industry.
The American Society for Health Care Engineering (ASHE) is the
largest professional membership group of the American Hospital
Association. The ASHE is comprised of over 12,000 professionals who
design, build, maintain, and operate healthcare facilities. ASHE
members include health care facility managers, control specialists, and
others. ASHE has developed best practices for minimizing the risk from
COVID-19. These best practices can be, and have been, used by ASHE
members' organizations to develop their individual plans. (ASHE,
December 23, 2020)
The ASHE best practices are a collection of strategies which can be
implemented to reduce the spread of COVID-19. The ASHE best practices
recommend a multilayered control strategy. ASHE states that healthcare
organizations are working to maintain physical distance of at least six
feet and one way that this has been achieved is by scheduling check-in
times to limit occupancy as well as other controls such as floor
markings. When physical distancing is not feasible, employers have
installed physical barriers, such as clear, acrylic plexiglass or
vinyl, along with requiring face masks. ASHE also states that
healthcare organizations have taken a combination of approaches for
cleaning and disinfection, such as cleaning workstations including
high-touch surfaces daily. ASHE also discusses health screening and
medical management. According to ASHE, some healthcare organizations
have implemented self-screening policies and procedures, including, for
example, having employees certify that they have not displayed symptoms
or been in recent contact with someone that has tested positive for
COVID-19. Finally, the ASHE best practices recommend ensuring that
ventilation systems are working properly, including ensuring that all
negative pressure spaces including AIIRs are properly maintained, and
that the circulation of outdoor air is increased as much as possible.
The ASHE best practices also provide employers with steps to verify
that CDC recommended guidelines for air changes and time required for
contaminate removal based on air changes are followed.
The American Health Care Association and the National Center for
Assisted Living (AHCA/NCAL), an association representing long term and
post-acute care providers, with more than 14,000 member facilities
including non-profit and proprietary skilled nursing centers, assisted
living communities, sub-acute centers and homes for individuals with
intellectual and development disabilities, has also developed best
practices for minimizing the risk from COVID-19 (AHCA/NCAL, 2021).
Similar to the ASHE best practices and other plans and best practice
documents that were reviewed, the AHCA/NCAL best practices contain many
of the controls that are required
by the ETS. Also similar to the ASHE and other best practice documents,
the AHCA/NCAL membership can use the AHCA/NCAL best practices to
develop their individual plans. For example, the AHCE/NCAL best
practices recommend implementing controls to maintain physical distance
including rearranging offices and workstations as needed, posting signs
and floor markers, and limiting the number of individuals permitted in
the workplace. In addition, the AHCA/NCAL best practices recommend the
use of facemasks and increased cleaning and disinfection. The best
practices also contain recommendations on health screening and medical
management. Members have implemented recommendations on self-
questionnaire policies and procedures for employees and all other
individuals before they can enter the site, including, for example,
recommendations on having employees certify that they have not
displayed symptoms or been in recent contact with someone that has
tested positive for COVID-19. The AHCE/NCAL best practices also contain
recommendations on conducting contact tracing while protecting the
employee's identity, and engaging in facility-wide protocols to protect
other employees.
The New Mexico EMT Association (NMEMTA) is a professional
organization supporting emergency medical technicians and others
serving the public in the emergency services sector (NMEMTA, March 29,
2020). Similar to other best practice documents that were reviewed, the
NMEMTA best practices contain many of the controls that are required by
the ETS and recommend a multilayered approach to infection control.
Furthermore, NMEMTA members can use this guidance to develop their
individual plans. The NMEMTA best practices recommend implementing
physical distancing controls when responding to an emergency as well as
when transporting patients. For example, NMEMTA provides guidance on
limiting the number of responders by implementing policies for
coordinating with dispatchers prior to initial assessment, and
additional work practices such as using radio communications to
minimize the number of responders on scene. Additionally, the NMEMTA
best practices recommend policies and procedures to limit the number of
EMS workers in the ambulance and provide guidance on installing
physical barriers to separate the driver from the treatment area of the
ambulance. The NMEMTA best practices also recommend policies for
requiring the proper PPE and respiratory protection for EMS employees
as well as for placing facemasks on patients and family members
traveling in the ambulance.
The National Association for Home Care & Hospice (NAHC) is a
nonprofit organization that represents the nation's 33,000 home care
and hospice organizations. NAHC also advocates for the more than two
million nurses, therapists, aides, and other caregivers employed by
such organizations to provide in-home services to some 12 million
Americans each year who are infirm, chronically ill, or disabled (NAHC,
March 3, 2020). NAHC developed best practices for home health and
hospice employers. The NAHC best practices recommend a multilayered
infection control plan to protect employees from COVID-19. These best
practices include strategies for maintaining physical distance,
including ways to limit instances where caregivers are within 6 feet of
other persons. For example, the NAHC best practices contain policies
for requiring household members to stay in separate rooms of the home
as much as possible and to maintain at least 6 feet of distance from
the caregiver when they must be in the same room. In addition, the best
practices recommend procedures to ensure the home space has good air
flow via an HVAC system or by opening windows and doors during the
visit. The best practices also provide guidance on implementing
protocols for performing hand hygiene and cleaning and disinfection of
the workspace, tools, equipment and other high touch surfaces. The best
practices also recommend requirements for the use of facemasks,
respirators, and other PPE for home health and hospice caregivers,
patients, and members of the household during the home visit.
Additionally, the best practices provide strategies for the
implementation of patient telehealth, as well as self-screening before
visits to prevent employee exposure to known or suspected COVID-19
patients without taking appropriate precautions (e.g., PPE and
respirators).
Examples of Existing Healthcare Employer Plans and Controls
OSHA also reviewed a number of existing plans prepared by hospitals
and other healthcare providers that also illustrate that employers in
the healthcare sector have implemented a multilayered approach to
protect their workers from COVID-19. MedStar Health, a not-for-profit
community health system comprised of physician offices, urgent care
centers, regional ambulatory care centers, and 10 community hospitals,
has developed and implemented a COVID-19 plan (MedStar, May 5, 2021).
The plan adopts a multilayered approach to protect workers from COVID-
19 across MedStar's facilities and contains many of the provisions also
required by the ETS. For example, MedStar requires controls to ensure
physical distancing, including, for example, restricting the entry of
visitors and non-essential employees to reduce occupancy. Additionally,
MedStar requires the use of facemasks by employees, patients, and
visitors. MedStar also requires employees to self-screen and monitor
for signs and symptoms of COVID-19 and for visitors to utilize the
telephone triage system when scheduling visits to isolate known or
suspected cases of COVID-19 infection. Finally, MedStar requires
cleaning and disinfection of the workplace daily, as well as hand
hygiene protocols before, during, and after all appointments and
procedures.
Other employer plans reviewed also adopt a multilayered approach to
COVID-19 protection (see, e.g., Cambridge Health Alliance, 2021; Johns
Hopkins Medicine, 2021; HCA Healthcare, 2021; Dignity Healthcare,
2021). With respect to physical distancing, employer plans include
strategies to reduce and restrict occupancy at facilities. For example,
employers have implemented staggered shifts for employees, as well as
teleworking arrangements, to help reduce occupancy and ensure physical
distancing. Employers have also expanded remote telemedicine
consultations so fewer patients with non-emergency conditions need to
visit hospitals and other facilities where patient care occurs to
receive medical care. In this respect, where video conferencing systems
cannot be used, employers have used other virtual options, such as
online secured patient portals with chat and messaging features, to
reduce the occupancy of healthcare facilities. Employers have also
implemented telephone triage systems, and, in this way, patients
identified as low risk for COVID-19 can be cared for virtually, if
appropriate, while patients identified as higher risk for COVID-19 can
be routed to the appropriate care. In addition, employers have reduced
or completely eliminated patient visiting hours for those patients with
suspected or confirmed COVID-19. Finally, employers have installed
floor markings as visual cues to stay six feet apart throughout the
facility, including common areas such as waiting rooms and cafeterias,
spaced public seating six
feet apart, and limited the number of people in a space, whenever
possible.
The employer plans cited above also include policies and procedures
for the installation of physical barriers to protect workers outside of
direct patient care areas when physical distancing may not be possible
at all times. For example, some hospitals have installed physical
barriers at checkpoints, to protect security guards, as well as at
reception desks and patient/visitor information counters, to protect
the employees working there, from exposure to visitors, patients, and
co-workers.
The employer plans reviewed also include policies and procedures
for the use of facemasks. Moreover, the plans include policies on
increased cleaning and disinfection. For example, the plans include
requirements that surfaces and equipment are thoroughly cleaned and
disinfected daily using products that are effective against COVID-19.
The plans also include policies on maintaining HVAC systems and using
system filters with a MERV rating of 13 or higher, as well as polices
for pre-screening patients and employees for COVID-19 (including
requirements for self-questionnaires designed to identify anyone who
has or is suspected to have COVID-19 before their arrival at the
facility).
OSHA has determined that developing a COVID-19 plan, as required by
the ETS, is feasible based on the evidence that employers in the health
care sector have developed plans that address many of the requirements
of the ETS. Additionally, national trade associations and other
organizations in the health care sector have developed best practices
to aid in the development of these plans (ERG, February 9, 2021). As
discussed in the Summary and Explanation (section [VIII]), the plan
must address the hazards identified per the hazard assessment required
by paragraph (c)(4) of the ETS and the employer must do regular
inspections to ensure ongoing effectiveness of the plan and update as
needed.
b. Implementation of Good Infection Control Practices
The ETS contains four provisions for good infection control
practices, each of which is discussed in detail in Need for Specific
Provisions and Summary and Explanation (Sections V and VIII of the
preamble, respectively):
Sec. 1910.502(d)--Patient screening and management. The purpose of
this provision is to limit contact with potentially infectious persons
by, for example, requiring screening and triage of everyone entering a
healthcare setting and limiting and monitoring points of entry to the
setting.
Sec. 1910.502(e)--Standard and transmission-based precautions. The
ETS requires that, in settings where healthcare services, healthcare
support services, are provided, the employer must develop and implement
policies and procedures to adhere to Standard and Transmission-Based
Precautions. Standard and Transmission-Based Precautions are
established and commonly used practices for reducing the risk of
transmission of infectious agents such as COVID-19.
Sec. 1910.502(f)--Personal protective equipment (PPE). The ETS
requires employers to provide and ensure employees use facemasks or
respirators in specified situations, and also requires the use of other
PPE, such as gloves and eye protection, in appropriate circumstances.
Sec. 1910.502(g)--Aerosol-generating procedures on a person with
suspected or confirmed COVID-19. Because aerosol-generating procedures
are known to be high risk activities for exposure to respiratory
infections such as COVID-19, the ETS contains special requirements to
address this hazard. For example, the employer must limit the number of
employees present during the procedure to only those essential for
patient care and procedure support.
Some of these controls are obviously feasible simply because of the
nature of the control. The process of screening, for example, can
typically be accomplished simply through questioning, so there are no
technological feasibility barriers to implementing those controls. To
support its assessment of the technological feasibility of other
controls in the ETS, OSHA reviewed evidence that shows that the
healthcare-specific good infection control practices identified in
Sec. 1910.502(d) through (g) are commonly implemented by employers who
have employees in healthcare settings. This evidence includes: CDC
infection control guidance documents, many of which are COVID-19
specific; regulations issued by the Centers for Medicare & Medicaid
Services (CMS); and accreditation of these settings by The Joint
Commission; and OSHA's Bloodborne Pathogens (BBP) Standard, 29 CFR
1910.1030. For example, Sec. 1910.502(e) requires compliance with the
CDC's Standard and Transmission-Based Precautions. As detailed below,
OSHA can show that this is technologically feasible by demonstrating
that at least some hospitals and other healthcare settings follow these
precautions (thereby showing it is capable of being done and can be
implemented in other healthcare settings).
To demonstrate that, OSHA points to two reasons why healthcare
employers comply with these precautions. First, OSHA's BBP standard
already requires hospitals and other healthcare facilities to implement
a parallel framework, often with similar systems and controls, to
comply with many of the same precautions. Even where the requirements
for some controls must be implemented somewhat differently under this
ETS than under the BBP standard, OSHA is not aware of technological
feasibility challenges that arise from these differences. For example,
a hospital's COVID-19 plan will be different from its BBP Exposure
Plan, but the planning process will already be familiar to the hospital
and there should be enough similarities in the construction of plans
identifying and addressing hazards that there will not be any
feasibility issues with formulating the COVID-19 plan.
Second, healthcare employers must have an infection control program
that includes Standard and Transmission-Based Precautions to be
eligible for certain government funds (CMS distribution of Medicare and
Medicaid funds) or accreditation (The Joint Commission). CMS
regulations only cover providers that accept or collect payments from
Medicare or Medicaid. Compliance with the CMS regulations is generally
validated through periodic accreditation surveys of facilities by CMS-
approved accreditation organizations, including The Joint Commission,
state survey agencies, and other accrediting organizations (e.g.,
Accreditation Association for Ambulatory Health Care (AAAHC)). CMS and
The Joint Commission reliance on largely the same criteria as this ETS
means that the technological feasibility of the ETS is supported by
those hospitals and other healthcare settings who do have to comply by
proving that the requirements are capable of being done.\28\
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\28\ OSHA notes that its assessment in this section addresses
only whether the ETS is technologically feasible. The fact that many
health care facilities have already implemented some version of the
controls required by the ETS does not mean that there is no need for
the ETS to apply to healthcare. Again, CMS regulations only cover
providers that accept or collect payments from Medicare or Medicaid.
In addition, OSHA has in place enforcement mechanisms that CMS does
not have and that would work in concert with CMS to achieve a
greater level of compliance. For example, OSHA can respond to
complaints, conduct random unannounced inspections, and conduct
worksite inspections in response to complaints filed by workers. As
described elsewhere in this preamble, the ETS is necessary to
address the grave danger posed by COVID-19. See Rationale for the
ETS, Grave Danger and Need for the ETS (Section IV of the preamble).
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CDC Infection Control Guidance Documents
The CDC has issued infection control guidance, listed in Table
VI.A.-3, that apply to the following settings and industry groups:
Hospitals and ambulatory care, plasma and blood collection facilities
and dialysis facilities, home health care, emergency responders and
prehospital care, autopsies, long-term care, and dental and oral care.
These guidelines provide infection-control recommendations for use in
the settings covered by the ETS (listed in Table VI.A.-3). The guidance
provides recommendations for implementing policies and practices to
minimize the risk of exposure to respiratory pathogens, and many are
recently issued guidelines specific to COVID-19.
BILLING CODE 4510-26-P
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BILLING CODE 4510-26-C
The CDC guidelines in Table VI.A.-3 are commonly implemented,
longstanding, and essential elements of infection control in healthcare
settings (i.e., the settings listed in Table VI.A.-1), evidenced by the
CDC's 2007 Guideline for Isolation Precautions: Preventing Transmission
of Infectious Agents in Healthcare Settings (Item 8 in Table VI.A.-3,
above), which incorporates Standard and Transmission-Based Precautions
into its recommendations. This 2007 Guideline updated 1996 guidelines,
which introduced the concept of Standard Precautions, and also noted
the existence of infection control recommendations dating back to 1970.
The implementation of the CDC guidelines is also evidenced by
regulations issued by the Centers for Medicare & Medicaid Services
(CMS) that apply to settings in Table VI.A.-1 and the accreditation of
settings in Table VI.A.-1 by The Joint Commission, as described below.
OSHA notes that guidelines that are grouped with one setting in
Table VI.A.-1 may apply to other settings as well. For example, the
Interim Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (Item
1 in Table VI.A.-3) applies to Emergency Medical Personnel, Home Health
Care, and Long-Term Care, in addition to applying to Hospitals and
Ambulatory Care.\29\
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\29\ The guidance is applicable to all U.S. settings where
healthcare is delivered, and defines ``healthcare setting'' as
places where healthcare is delivered. According to the guidance,
this includes acute care facilities, long-term acute care
facilities, inpatient rehabilitation facilities, nursing homes and
assisted living facilities, home healthcare, vehicles where
healthcare is delivered (e.g., mobile clinics), and outpatient
facilities, such as dialysis centers, physician offices, and
others.'' Moreover, the guidance defines ``healthcare personnel,''
or HCP, as all paid and unpaid persons serving in healthcare
settings who have the potential for direct or indirect exposure to
patients or infectious materials, including body substances (e.g.,
blood, tissue, and specific body fluids); contaminated medical
supplies, devices, and equipment; contaminated environmental
surfaces; or contaminated air. According to the guidance, HCP
include emergency medical service personnel, nurses, nursing
assistants, home healthcare personnel, physicians, technicians,
therapists, phlebotomists, pharmacists, students and trainees,
contractual staff not employed by the healthcare facility, and
persons not directly involved in patient care, but who could be
exposed to infectious agents that can be transmitted in the
healthcare setting (e.g., clerical, dietary, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel).
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CMS Regulations That Condition Participation in Medicare and Medicaid
on Implementation of Nationally Recognized Infection Control Guidelines
The Centers for Medicare & Medicaid Services (CMS) administers
healthcare programs for the elderly (Medicare) and needs-based state
programs that help with medical costs (Medicaid). As a condition for
participation in Medicare or Medicaid, medical providers must comply
with regulations issued by the Department of Health and Human Services
(DHHS), 42 CFR Pts. 400-699. A number of these regulations, which apply
to a broad spectrum of the settings listed in Table VI.A.-1, condition
participation in Medicare and Medicaid on the implementation of
nationally recognized infection control practices like the CDC
guidelines listed in Table VI.A.-3. The applicable CMS regulations are
summarized in Table VI.A.-4.
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Accreditation by The Joint Commission
Founded in 1951, The Joint Commission is an independent, not-for-
profit organization that accredits and certifies more than 22,000
healthcare organizations and programs in the United States (The Joint
Commission, 2021a). Joint Commission accreditation and certification is
recognized nationwide as a symbol of quality that reflects an
organization's commitment to meeting certain performance standards.
Joint Commission standards are the basis of an objective evaluation
process that can help healthcare organizations measure, assess and
improve performance. The standards focus on important patient,
individual, or resident care and organization functions that are
essential to providing safe, high-quality care (The Joint Commission,
2021b). To maintain accreditation, organizations undergo an on-site
survey by a Joint Commission survey team at least every three years
(laboratories are surveyed every two years). In these surveys, The
Joint Commission monitors compliance with its standards for the
implementation of good infection control and biosafety practices
(including, for example, adherence to Standard and Transmission-Based
Precautions, as recommended by the CDC Guidelines in Table VI.A.-3)
(The Joint Commission, 2021c). The Joint Commission offers
accreditation for the following settings (many of which are contained
in Table VI.A.-1) (The Joint Commission, 2021c):
Ambulatory care facilities;
Critical access hospitals;
Behavioral health care;
Hospitals;
Home care services;
Nursing care centers; and
Office-based surgery centers.
OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030
Employers subject to the ETS have also been subject to requirements
in the Bloodborne Pathogens (BBP) standard for 30 years, since it was
promulgated in 1991. As the BBP standard was promulgated, OSHA found
``with
respect to the technological feasibility of the standard that its
provisions permit practical means to reduce the risk now faced by those
employees working with blood and other infectious materials and that
there do not appear to be any major obstacles to implementing the
rule.'' (56 FR 64004, 64039 (Dec. 6, 1991)). OSHA's finding of
technological feasibility during the BBP standard rulemaking is
additional evidence that there are no technological feasibility
barriers to complying with the ETS.
For example, Standard Precautions, which are required by the ETS,
are similar to, but more extensive than, ``Universal Precautions'',
which are required by the BBP standard to prevent contact with blood or
other potentially infectious materials (see definitions in the BBP
standard). The BBP standard defines ``Universal Precautions'' as an
approach to infection control wherein all human blood and certain human
body fluids are treated as if known to be infectious for HIV, HBV, and
other bloodborne pathogens. Standard Precautions were developed to
integrate principles of Universal Precautions into broader principles
pertaining to routes of exposure other than the bloodborne route, such
as via the contact, droplet, or airborne routes. For example, although
the BBP standard might not apply, Standard Precautions would be
utilized when workers are exposed to urine, feces, nasal secretions,
sputum, vomit, and other body fluids, and also when workers are exposed
to mucous membranes and non-intact skin. Using Standard Precautions
when there is exposure to these materials, it should be assumed that
the materials potentially contain infectious agents that could be
transmitted via the contact, droplet, or airborne routes. Standard
Precautions not only include the infection control methods specified as
Universal Precautions (e.g., hand hygiene, the use of certain types of
PPE based on anticipated exposure, safe injection practices, and safe
management of contaminated equipment and other items in the patient
environment), but also include, for example, respiratory and cough
etiquette. The respiratory and cough etiquette and other additional
controls for Standard Precautions are minor expansions on the Universal
Precautions already applicable to most healthcare facilities, and OSHA
is not aware of any technological barriers for employers subject to the
ETS.
In addition to the above requirements, the BBP standard contains
requirements for an exposure control plan, engineering and work
practice controls, hand hygiene, personal protective equipment,
housekeeping (e.g., cleaning and decontamination), and vaccination,
which all have corollaries in the ETS. While there are differences
between the BBP standard and the ETS, there is overlap. For example,
although the requirements for a COVID-19 plan in the ETS are different
than those for the exposure control plan required by the BBP standard,
the process for developing and implementing these plans should be
similar. Based on this overlap, there should not be any technological
feasibility barriers to complying with the corollary provisions in the
ETS.
c. Physical Distancing and Physical Barriers
Physical Distancing: The ETS (paragraph (h)) requires the employer
to ensure that each employee is separated from all other people by at
least 6 feet unless the employer can demonstrate that such physical
distancing is not feasible for a specific activity, and that, when the
employer establishes it is not feasible for an employee to maintain a
distance of at least 6 feet from all other people, the employer must
ensure that the employee is as far apart from all other people as
feasible.
Physical Barriers: The ETS (paragraph (i)) requires that at each
fixed work location outside of direct patient care areas where an
employee is not separated from all other people by at least 6 feet of
distance, the employer must install cleanable or disposable solid
barriers, except where the employer can demonstrate it is not feasible
(or the paragraph (a)(4) exception for vaccinated employees applies).
As discussed above, OSHA reviewed a number of plans and best
practice documents developed and employed by the healthcare sector to
reduce the risk of COVID-19 exposure. These plans included
recommendations and requirements for the implementation of physical
distancing and physical barriers in the settings covered by the ETS.
These plans and best practice documents provide strong evidence that it
is technologically feasible to implement these controls in the
healthcare sector. Moreover, OSHA developed physical distancing
scenarios and a job matrix spreadsheet, discussed below, which also
provide strong evidence that the implementation of physical distancing
and physical barriers is technologically feasible in the healthcare
sector.
Physical Distancing Scenarios
OSHA developed ``physical distancing'' scenarios for a variety of
workplaces covering a wide range of situations to describe the controls
that have been put in place to maintain not only physical distancing
but also physical barriers at each fixed work location outside of
direct patient care areas (e.g., entryway/lobby, check-in desks,
triage, hospital pharmacy windows, bill payment), as well as other
controls required by the ETS as part of a multilayered strategy to
reduce or eliminate the transmission of SARS-CoV-2. As OSHA discusses
in more depth below, these scenarios are based primarily on COVID-19
plans developed by employers.
OSHA uses these scenarios (and by extension the plans on which they
are based) to support its feasibility determination regarding the
physical distancing and physical barrier requirements of the ETS, and
also to show that other controls required by the ETS are being, or can
be implemented, by typical employers across affected workplaces.
OSHA also uses these scenarios to explore ways to mitigate the
remaining risk of exposure when it is infeasible to comply with the
requirements for physical distancing. While this portion of the
analysis falls outside the pure examination of the technological
feasibility of the required controls, it is intended to demonstrate the
steps that employers are expected to take to reduce exposure risk. Some
of the plans that OSHA consulted in developing these scenarios include
examples of controls that would not meet the requirements of the ETS,
but OSHA has attempted to incorporate some of these examples into the
scenarios while noting that some of the controls may only be used when
the other controls are infeasible.
Thus, for example, some scenarios describe the use of both physical
distancing and physical barriers by employers. OSHA's description of
the scenarios below should not be read to mean that OSHA sanctions the
use of physical barriers in lieu of physical distancing, when physical
distancing is feasible. For an in-depth discussion on the rationale
underlying OSHA's rulemaking decisions, please see Need for Specific
Provisions (Section V of the preamble).
As another example, some scenarios describe facemasks, ventilation,
and other controls required by the ETS as additional controls when
physical distancing is not feasible. But these controls are not
alternatives to physical distancing under the ETS. Again, physical
distancing (or physical barriers at fixed workstations outside of
direct patient care areas, when physical distancing is not feasible)
must be
implemented alongside these controls under the ETS as part of a
multilayered approach to infection control.
Finally, OSHA emphasizes that physical distancing is feasible for
the vast majority of situations employers may face in their daily job
duties. There are a select number of situations where physical
distancing is not feasible, and for these situations, employers must
implement physical barriers if feasible at fixed work locations outside
of direct patient care areas. And, again, employers must implement the
other controls as required by the standard (e.g., facemasks, and
respirators, cleaning and disinfection, health screening and medical
management, employee notification).
In reviewing the record, OSHA found that, while exposure to COVID-
19 can occur from contact with co-workers or the public as part of
healthcare workers' job duties in a wide range of workplaces covered by
the ETS, many of the processes and controls used to minimize risk are
the same or similar.
The physical distancing scenarios OSHA's contractor--a safety and
health subject matter expert--developed include examples of policies
and procedures implemented to maintain physical distancing, physical
barriers, and other controls based on a review of guidance and existing
pandemic plans and other sources. This information was supplemented
where needed with additional internet searches, for instance, from news
articles, industry surveys, or articles in industry publications that
demonstrate how companies in different industries have been
implementing physical distancing. The contractor also relied on its
professional expert judgment (ERG, February 25, 2021). The scenarios
identify groups of workers who face similar work situations with regard
to physical proximity (within 6 feet) of another person (e.g.,
visitors, members of the public), and for whom the same or similar
precautions to limit physical proximity can be implemented. In this
respect, some of the evidence on which OSHA relies in this assessment
(with respect to the offices, law enforcement, security guards, and
protective services, home healthcare, personal care, and companion
service providers, and postmortem services scenarios) rely on plans and
best practices from both industries affected by this ETS and other
industries not affected by the ETS. In analyzing the evidence of
physical distancing and barriers across multiple industry sectors, OSHA
observed that the feasible methods of implementing physical distancing
and physical barriers for employees with similar exposures was similar
regardless of industry (for example, employing physical distancing and
barriers to protect administrative and clerical staff, receptionists,
those who are exposed to human remains, and those who enter personal
residences to provide care). To this end, OSHA's assessment of the
feasibility of implementing physical distancing and physical barriers
in the healthcare section is based on evidence from other industries to
the extent that workers share similar job roles and perform similar job
tasks such that the feasibility of distancing and barriers would be the
same in either case.
OSHA also developed a job matrix spreadsheet to identify groups of
workers facing similar work situations. To develop this spreadsheet,
OSHA first found and reviewed 418 plans from employers representing
various separate 3-digit North Industry Classification System (NAICS)
codes, and 286 best practice documents from trade associations and
other organizations covering 46 3-digit NAICS codes (ERG, February 9,
2021). As part of the review, OSHA included plans and best practices
from industries outside of healthcare to clearly demonstrate the
feasibility of implementing a multilayered approach to COVID-19
infection control (including facemasks and the installation of physical
barriers where distancing is not feasible) for similar work situations.
Next, OSHA identified unique job categories across the industry
sectors with many categories present across multiple NAICS codes. These
job categories were cross-referenced with the scenarios to develop the
job matrix spreadsheet (February 25, 2021). This job matrix spreadsheet
was used to identify job categories facing similar situations regarding
the ability to maintain physical distance with coworkers and/or members
of the public. OSHA expects that, for these situations, employers can
implement the same or similar precautions, for not only limiting
physical proximity, but also for the other multilayered controls
required by the ETS. Workers with public-facing job duties, such as
receptionists and security guards, share many of the same or similar
exposure control challenges, and employers of these job categories over
a wide variety of industry sectors have implemented similar
multilayered controls such as physical distancing, the installation of
barriers, requirements for face masks, and hand hygiene, among others,
as discussed below (February 25, 2021). OSHA concludes, based on the
job matrix that evidence of feasibility for one scenario also
establishes feasibility for other scenarios to the extent job
categories cut across scenarios.
The scenarios OSHA developed for the healthcare sector are listed
in Table VI.A.-5.
[GRAPHIC] [TIFF OMITTED] TR21JN21.008
Below, OSHA highlights some of the elements of these scenarios and
portions of the job matrix on which it relied. In the discussion below,
OSHA will first describe some of the types of jobs workers conduct in
most workplaces in the scenarios discussed (or across scenarios to the
extent this is supported by the job matrix), and identify some of the
unique work processes that are already conducted in a physically
distanced manner or that can be easily modified to avoid or reduce
physical proximity for each scenario discussed (or, as applicable,
across scenarios). OSHA then describes some of the discrete activities
where physical contact with others (i.e., the public or other workers)
may be necessary or unavoidable, along with the precautions and
controls that can still feasibly be implemented for the scenarios (or,
as applicable, across scenarios) as part of a multilayered approach to
protection, such as facemasks, ventilation, and the use of physical
barriers.
In this respect, OSHA's analysis found employers have implemented
physical barriers at fixed work locations outside of direct patient
care areas (e.g., entryway/lobby, check-in desks, triage, hospital
pharmacy windows, bill payment). Physical barriers are required as part
of the multi-layered approach to infection control that is at the heart
of the ETS. As discussed more fully in the Need for Specific Provisions
(Section V of the preamble), physical barriers, when properly
installed, are effective at intercepting respiratory droplets and
minimizing the risk of exposure to COVID-19, especially in areas where
employees cannot maintain a minimum of 6 feet of distance from
coworkers, customers, and members of the general public.
The ETS does not specify the type of material that must be used for
physical barriers, but the material must be impermeable to infectious
droplets that are transmitted when an infected individual is sneezing,
coughing, breathing, talking, or yelling. In addition, physical
barriers must be made from materials that can be easily cleaned and
disinfected unless in lieu of cleaning the employer may opt to replace
the barrier. Using replaceable materials would allow an employer to
dispose of and replace barriers between uses, instead of cleaning and
disinfecting more permanent barriers. The effective design and
implementation of physical barriers will differ among workplaces based
on job tasks, work processes, and even potential users. Physical
barriers must be designed, constructed, and installed to prevent
droplets from reaching employees when they are in their normal sitting
or standing location relative to the workstation. For example, under
the provision, plastic sheeting can qualify as a physical barrier only
in situations where it is fixed in place and blocks face-to-face
pathways of air between the users on either side while those workers
are performing all of their assigned tasks.
Examples of physical barriers across a variety of workplaces are
discussed in the scenarios below. Further considerations for the design
and implementation of physical barriers to properly block face-to-face
pathways of breathing zones, including whether plastic sheeting, films,
curtains, and other non-rigid materials are acceptable materials, as
well as installation, are discussed in the summary and explanation of
Physical Barriers.
Employers subject to the ETS share a common challenge: Finding ways
to limit physical proximity (of less than 6 feet) between each worker
and other workers, as well as visitors and other non-employees in the
workplace. In the limited situations where physical distancing is not
feasible, employers often face similar challenges and employ similar
solutions in designing and installing physical barriers to help protect
their employees, even though the types of products or services they
offer or the work they do vary. For example, employers often install
physical barriers with a pass-through space at the bottom.
A barrier is thus an effective tool in helping to protect a
security guard at a check point at a hospital's entrance, a
receptionist in the billing department, and any other public-facing
employee. Physical barriers have also been installed to shield
healthcare workers and others from individuals with suspected or
confirmed COVID-19 (for example in triage areas of an emergency
department). Employers have also installed barriers between urinals and
sinks in restrooms both as separations between persons using the
facility and as a splash guard (ERG, February 9, 2021; ERG, February
25, 2021).
As the assessment below makes clear, OSHA has found no feasibility
issues with the implementation of physical distancing or physical
barriers in typical operations in the healthcare sector.
General Office Settings
General office settings are common across a number of industry
sectors, and many healthcare facilities have areas
with administrative offices similar to general office settings. OSHA
developed a physical distance scenario for offices by identifying
industry sectors where office worksites are common. OSHA found that
employers have successfully implemented a variety of physical
distancing measures (measures to keep people 6 feet apart) by
incorporating administrative and engineering controls for the various
job categories that work in offices such as supervisors and managerial
staff, administrative and clerical staff, and receptionists.
Administrative and clerical workers are a common job category
within office worksites across a wide variety of industries. In
addition to the offices scenario, administrative and clerical workers
were identified in a number of other physical distancing scenarios
including: Law enforcement, security guards, and protective services;
postmortem care; and long-term care (although OSHA believes
administrative and clerical workers likely work within most scenarios,
given that administrative and clerical work is usually necessary
regardless of industry sector).
A number of strategies for maintaining physical distancing as part
of a multilayered approach have been implemented for administrative and
clerical staff, including establishing remote work, altering the work
environment to limit the number of chairs and workstations, relocating
workers to locations that ensure proper physical distancing, and
arranging visitor seating areas to be at least 6 feet away from
employees' desks. Employers can also adopt telehealth services to
completely isolate clerical and administrative staff from the patients,
clients, and other people they might otherwise be interacting with in
person. Meetings can be conducted virtually, or conference tables and
chairs can be relocated to areas of the office where physical
distancing can be ensured. Employers may also establish occupancy
limits for certain rooms (e.g., bathrooms, breakrooms, elevators,
lunchrooms, and changing areas), stagger breaks to limit the number of
workers on break at the same time, and use signs and markings to
communicate occupancy limits and to remind workers to keep 6 feet
apart. Shared equipment, such as copiers or printers, can also be
located more than 6 feet apart so that different employees can use that
equipment at the same time without having to be close to each other.
OSHA notes that many supervisors and managers (e.g., hospital
administrators) have many of the same types of exposures as
administrative and clerical staff. They commonly work in communal
office areas, engage in collaborative group work, and hold office
meetings in conference rooms. Moreover, as supervisors and managers,
they implement the physical distancing strategies described above for
the facilities where they work, and not just to apply to administrative
and clerical staff.
While receptionists are a common job category within office
worksites, they are also employed in a variety of industry sectors.
Receptionists are public-facing employees and their jobs include tasks
which routinely put them in contact with the public, such as greeting
and directing patients and families appropriately, responding to
inquiries, coordinating with first responders or law enforcement,
working with patients to process medical billing and paperwork, and
maintaining security and telecommunications systems.
OSHA identified a number of physical distancing strategies that
have been commonly used to increase physical distancing for
receptionists. When telework is not possible, employers have eliminated
reception seating areas, closed lobbies, and required patients and
visitors to phone or text ahead for entry into the workplace. In
addition, signs and floor marks indicating 6-foot spaces where lines
can form in reception areas have been found to help maintain physical
distance between visitors and receptionists. When limiting access to
reception areas is difficult, employers have reduced occupancy by only
allowing seating at every other chair in waiting areas. Touchless or
remote payment and scheduling options have been successfully used to
limit face-to-face interactions with customer clients.
As discussed above there are many options of potential controls to
provide physical distancing for supervisors and managers,
receptionists, administrative and clerical workers, and other office
workers who work in office settings. However, there may be limited
instances where employees might be unable to physically distance all of
the time. As part of a multilayered approach to transmission control,
physical barriers have been installed in office settings across all
industry sectors. For example, workers in office settings (e.g.,
medical billing and financial service, transcription, and medical
records departments) often spend the majority of the day at their desks
or other fixed workstations. For these situations, employers have
installed plexiglass barriers or partitions between workstations and
between public-facing staff and patients, families, customers, clients,
and other non-employees. At public facing workstations, physical
barriers with small openings have been installed to enable the passing
of paperwork and payment machines, for example. Under the ETS, when it
is not feasible for employees to be properly distanced from each other,
barriers must also be installed between the employees.
Law Enforcement, Security Guards, and Protective Services
A physical distance scenario developed particularly for law
enforcement, security guards, and protective services identified a
number of industry sectors where job categories within the scenario are
common. OSHA found that employers of security guards have successfully
implemented a variety of physical distancing controls to maintain 6
feet of physical distance from other people.
Common physical distancing controls for security guards include
staggering work shifts and limiting or ending in-person meetings. The
use of walk-through metal detectors instead of hand-held wands and
electronic mobile credentials to avoid the need for security officers
to physically check individuals have also been implemented (if wands
are used, the person being wanded should face away from the security
guard). Electronic mobile credentials can also be centrally managed
from a remote location, limiting the need for personnel to visit
badging offices. Employers have utilized signs, floor markings, and
ropes to mark a 6-foot distance around security guard stations to
remind people who are standing in line to maintain appropriate distance
from the security officer and other people in line.
As part of a multilayered approach to transmission control,
employers have also installed physical barriers to protect these
workers when they are at fixed workstations. Across healthcare
workplaces, employees working in security checkpoints are commonly
unable to maintain physical distance from non-employees who need to be
checked-in or are waiting in line (for example, during identification
screenings at hospital entrances). In such circumstances, the
installation of barriers helps protect security personnel interacting
with the public.
Emergency Medical Services
OSHA developed a physical distancing scenario for Emergency Medical
Service (EMS) organizations. EMS workers cover a number of job
categories including emergency medical
technicians (EMTs), paramedics, and cross-trained firefighters serving
in the capacity of paramedics or EMTs.
OSHA identified a number of common physical distancing controls
implemented by EMS providers, which limit the number of onsite workers
within physical proximity of patients and others, and also limit crowd
size during emergency response. First, to limit the number of EMS
workers that respond to a call to those absolutely necessary, EMS
employers have implemented polices to coordinate with the emergency
response operator (e.g., the 911 operator/dispatcher) on how many EMS
responders are needed. Also, employers have implemented policies to
ensure that the emergency response operator coordinates with law
enforcement to disburse or move unnecessary people before the ambulance
arrives. Additionally, employers have instituted work practices where
one EMS worker conducts the initial patient evaluation and performs
medical treatment, remaining in radio communication with the other EMS
worker, who will enter to assist only if necessary. EMS employers have
also instituted policies to limit the number of workers in the
ambulance to those who are medically necessary and to encourage family
members to follow the ambulance in their own vehicle rather than riding
in the ambulance.
EMS workers cannot always avoid proximity to coworkers or patients
during some operations including, for example, engaging in emergency
medical care, transporting patients in ambulances, and transferring
patients to healthcare facilities. When EMS workers respond to an
emergency, they are involved in evaluating and treating the patient
onsite before transporting the patient as necessary. EMS workers may
need to work as a team in order to perform some tasks (e.g., while
performing cardiopulmonary resuscitation (CPR) and using a bag valve
mask also known as an Ambu bag). In addition, arriving EMS workers
could be within 6 feet of people at the site, including family members
and the general public who may have gathered.
Employers of emergency medical services (EMS) workers have
installed physical barriers to protect their workers in at least some
of these situations. For example, physical barriers are often installed
between the workstations of emergency response operators, who assist in
coordinating the response to emergency situations (e.g., for the EMS
system or the public health system, and in 911 call centers or
healthcare facilities). Employers have also installed physical barriers
between the treatment compartment of ambulances and the driver's
compartment to protect drivers and other workers who need not be
exposed to patients.
OSHA also identified a number of strategies that have been used by
EMS providers as part of a multilayered approach to infection control.
Employers have implemented policies for requiring employees to wear
appropriate respiratory protection and other PPE, placing a face
covering or facemask on the patient when possible, and requiring family
members to wear face coverings or leave the area while EMS workers
respond to emergencies in patient homes. In addition, employers have
instituted protocols for moving a patient with confirmed or suspected
COVID-19 outside or in a more ventilated area for treatment where
medically possible (note that the ETS requires healthcare workers to
wear respirators when treating a patient who is confirmed or suspected
to have COVID-19 as well as when they are exposed to aerosol-generating
procedures conducted on a patient who is confirmed or suspected to have
COVID-19).
In some situations, EMS workers might need to ride in the cab
within 6 feet of each other as well as the patient being transported.
In these situations, overlapping controls, such as requiring all EMS
workers in the patient compartment to wear appropriate PPE and to wash
their hands or use an alcohol-based hand sanitizer that contains at
least 60% alcohol, have been implemented. Moreover, as stated, where
feasible, physical barriers can be constructed to isolate the driver's
cab from the rear patient care area. In addition, patients riding in
the rear compartment can wear a face covering and face shield, when
possible, or at least a face shield when a face covering is not
possible. Employers have also established procedures to open outside
air vents in the cab and turn on the rear exhaust ventilation fans to
the highest setting to create a pressure gradient toward the patient
area.
It is also common that EMS operations must quickly return an
ambulance to service after responding to an emergency involving, or
transporting patients who are, COVID-19 positive. In such
circumstances, multiple EMS workers must often concurrently participate
in cleaning and disinfection of the patient area in the ambulance. In
these situations, employers have used outdoor cleaning areas or indoor
exhaust ventilation, in addition to following widely-established
polices requiring PPE and face coverings.
Long-Term Care
Long-term care employers operate nursing homes, retirement
communities, assisted living facilities, and intermediate and
continuing care facilities. There are a wide range of job titles for
workers in this industry including healthcare providers (e.g.,
physicians, nurses, nurses' assistants, orderlies, physical,
occupational, and speech therapists, personal care aides, and
psychiatric aides), as well as support staff (e.g., facility
administration, reception, engineering and maintenance, housekeeping,
laundry, food service, transportation, pharmacy, and security).
OSHA identified a number of physical distancing strategies that
have been implemented in various areas of long-term care facilities
such as reception areas, waiting rooms, dining rooms, and common areas.
These strategies include: Restricting the number of visitors; limiting
access to the residential area to essential workers (i.e., maintenance
workers performing non-critical tasks and staff performing billing
services would not be granted access); increasing the number of meal
services; limiting the number of residents in the dining area at one
time; and providing room service.
Although physical distancing can be feasibly maintained most of the
time, there are some situations where workers in long-term care
facilities cannot always avoid physical proximity with residents,
visitors, or co-workers. Long-term care employers have installed
physical barriers to protect employees in many of these situations. For
example, resident care and front desk staff may need to be within 6
feet of visitors during visitor check-in or when providing information
or assistance, and administrative staff may have a central counter for
information and resources for residents. In these situations, employers
have installed physical barriers between workstations and visitor or
resident areas. Food servers and aides may need to be within 6 feet of
a resident when serving food, servicing or clearing buffet food lines,
and when providing assistance. In these situations as well, employers
have installed physical barriers between employees and residents.
Healthcare providers may also need to provide care or therapy in
resident rooms or other care/therapy areas. As part of a multilayered
approach to infection control, some employers have required workers
caring for residents to wear a gown, safety glasses, gloves, and either
a surgical mask or N95 respirator (depending on whether the worker is
providing care to residents with suspected or confirmed COVID-19, for
example). Also, in accordance with American Health Care Association/
National Center for Assisted Living (AHCA/NCAL) recommendations,
employers have, to the extent possible, reduced the frequency of
routine procedures, such as taking vital signs and weights, and have
also required residents to wear a face covering when staff enter their
rooms or when receiving care/therapy from a healthcare provider, unless
they are medically unable to do so. Many employers have also
implemented cohorting procedures for staff and patients (i.e.,
assigning staff to specific residents and only those residents) while
minimizing staff working across units (AHCA and NCAL, April 21, 2020).
Home Healthcare, Personal Care, and Companion Service Providers
OSHA developed a physical distancing scenario for organizations
that visit private residences to provide healthcare services and health
care support services. Employers in this industry use a wide range of
job titles for their workers including professional home healthcare
practitioners (e.g., physicians, nurses, medical technicians); personal
care providers (e.g. self-care aides); and other workers who offer
companion services for disabled persons, the elderly, and persons
diagnosed with intellectual and developmental disabilities.
To help ensure physical distancing, employers in this industry have
switched to virtual services when possible by determining whether some
clients' needs can be met through telehealth or with online technology,
such as video conferencing. Many physical distancing strategies have
also been implemented by employers of this sector when services must be
conducted at a patient's private residence. These include implementing
protocols for workers to maintain 6 feet of distance from clients and
other household members, and for workers providing service in teams to
maintain 6 feet of distance from each other, as much as possible while
they perform their work. Employers have also implemented procedures to
instruct all people within the household (other than the direct client
receiving services) to go to another room, or at a minimum, maintain at
least 6 feet of distance from workers.
Workers performing in-home healthcare or personal care services
cannot always feasibly maintain 6 feet of physical distance from their
clients or co-workers. In these situations, companies have successfully
implemented a multi-layered suite of controls such as requiring all
workers to wear facemasks, respiratory protection, or other PPE, and
requiring patients and members of households to self-screen for COVID-
19 before the visit. Also employers have required all workers to wash
their hands or use an alcohol-based hand sanitizer that contains at
least 60% alcohol before and after each visit, and have implemented
administrative controls such as assigning workers to ``bubbles'' or
cohorts to reduce the number of other individuals with whom a worker
comes in physical proximity. Finally, employers have taken steps to
ensure that private residences have adequate airflow by way of either
an HVAC system or open windows and doors.
Postmortem Services
OSHA developed a physical distancing scenario to address the
conduct of autopsies. Jobs involved in conducting medical autopsies
generally fall within the following categories; medical examiners,
forensic pathologists, and autopsy technicians who examine bodies
postmortem; and administrative and clerical staff who may be essential
for support purposes.
The postmortem care industry has implemented a variety of physical
distancing controls to prevent physical proximity (within 6 feet) of
other people when performing autopsies. Physical distancing controls
for these situations are meant to keep professional healthcare
practitioners and, in some cases guests (e.g., law enforcement, family
members of the deceased), at least 6 feet apart. These strategies
include posting reminders of the need to maintain at least 6 feet of
physical distance from other persons, where possible, training workers
on proper physical distancing relative to other workers and guests, and
establishing work schedules (e.g., alternating days, extra shifts) that
reduce the total number of workers in a facility at any given time. In
addition, many employers require workers to limit the number of staff
in the prep/exam room at any given time to the minimum number
necessary.
In workplaces where autopsies are performed, physical proximity
cannot always be avoided. In these situations, facilities have
successfully implemented a multi-layered suite of controls, such as
wearing appropriate PPE, to protect workers from other people (e.g.,
guests or other staff) during postmortem medical examination, for
example. Physical barriers have also been installed in other areas
where physical distancing may be difficult to maintain including, at
reception counters, in restrooms, in consultation rooms, and in
offices, for example.
Summary of Feasibility Challenges for Distancing and Physical Barriers
While OSHA strongly emphasizes the use of physical distancing and
physical barriers, it recognizes that there are a few situations where
employers have found that it is not feasible to implement either or
both. Physical distancing and physical barriers may not be feasible
during direct patient care, including the conduct of Emergency Medical
Services (EMS) while treating a patient in the back of an ambulance,
for example. Physical barriers may also be infeasible where they
obstruct an emergency egress path or interfere with a facility's fire
safety systems (e.g., fire alarm notification devices, fire sprinklers,
fire pull stations).
OSHA emphasizes a multilayered approach for employers to protect
their workers: Physical distancing and, if necessary, physical barriers
at fixed work locations outside of direct patient care areas must be
used in conjunction with other controls, such as facemasks, hand
hygiene, and ventilation, and not as the sole means of control. When
confronting the rare situations where both physical distancing and
physical barriers are not feasible, employers can still implement the
remaining layers of overlapping controls, including facemasks, hand
hygiene, and ventilation, required by the standard to reduce the risk
of COVID-19 transmission.
Based on the evidence that physical distancing and physical
barriers are already being implemented across a broad range of
healthcare settings, OSHA concludes that it is feasible to implement
the ETS's requirements for physical distancing and for physical
barriers at fixed work locations outside of direct patient care areas
(e.g., entryway/lobby, check-in desks, triage, hospital pharmacy
windows, bill payment). In the few cases where physical distancing and
physical barriers are both not feasible, work can be conducted to
maintain as much distance as possible, and the additional controls such
as facemasks, ventilation, and hygiene required by the ETS will still
provide some measure of protection.
d. Ventilation
Ventilation systems are another necessary part of a multilayered
strategy to control transmission of COVID-19 (CDC, March 23, 2021). As
will be discussed in more detail below, the
ability of heating, ventilation, and air conditioning (HVAC) systems to
reduce the risk of exposure depends on many factors, including design
features, operation and maintenance practices, and the quality and
quantity of outdoor air supplied to the space. Paragraph (k) of the ETS
require employers who own or control buildings or structures with
existing heating, ventilation, and air conditioning (HVAC) systems to
ensure that: (1) Each HVAC system is used in accordance with the HVAC
manufacturer's instructions and its design-specifications; (2) the
amount of outside air circulated through its HVAC system and the number
of air changes per hour (ACHs) are maximized to the extent appropriate;
(3) all air filters are rated Minimum Efficiency Reporting Value (MERV)
13 or higher, if compatible with the HVAC system (or, alternatively,
rated at the highest compatible filtering efficiency); (4) all air
filters are maintained and replaced as necessary; and (5) all outside
air intake ports are clean, maintained, and cleared of any debris that
may affect the function and performance of the HVAC system. Moreover,
where an employer has an existing airborne infection isolation room
(AIIR), the employer must maintain and operate it in accordance with
its design and construction criteria.
In the remainder of this section, OSHA discusses how employers can
comply with these requirements and then draws its conclusion on
technological feasibility.
Using HVAC Systems in Accordance With Manufacturer's Instructions and
Design Specifications
To meet the ETS's requirements, employers must verify that the
system is functioning as designed. Because each building and its
existing HVAC systems will be different, the employer might need to
consult a professional engineer or HVAC specialist to determine the
best way to maximize the system's ventilation and air filtration
capabilities for each specific room in the building and thereby ensure
the system is operating according to design specifications.
The American Society of Heating, Refrigeration and Air Conditioning
Engineers (ASHRAE) Standard 180-2018 Standard Practice for Inspection
and Maintenance of Commercial Building HVAC Systems provides guidance
on preventive maintenance for HVAC systems, including checklists that
employers can use to verify the system is operating as designed
(ASHRAE, June 11, 2018). Additional guidance can be found in CDC's
Guidance for Businesses and Employers Responding to Coronavirus Disease
2019 (COVID-19) (CDC, March 8, 2021), and the ASHRAE Guidance for Re-
Opening Buildings (ASHRAE, October 5, 2020).
Healthcare settings have additional HVAC design parameters for
meeting specifications for directional airflow and relative pressure
differentials. For example, according to ASHRAE's Standard 170
Ventilation of Health Care Facilities, ventilation systems that provide
air movement from clean areas (e.g., nursing stations) to potentially
contaminated areas (e.g., patient airborne infection isolation rooms)
are recommended for preventing airborne transmission. Thus, the air
pressure of the room or space would be maintained at a negative
pressure relative to the hallways and surrounding spaces. This means
that when the door is opened, potentially contaminated air or other
dangerous particles from inside the room will not flow outside into
non-contaminated areas. (ASHRAE, 2017). Normally functioning existing
isolation rooms should already be able to serve this function because
Joint Commission accreditation and Centers for Medicare & Medicaid
Services (CMS) regulations have requirements for negative pressure
airborne infection isolation rooms design.
Using AIIRS in Accordance With Design and Construction Criteria
AIIRs are designed to prevent the transmission of airborne
transmissible agents to areas outside a patient's room. These rooms
have a high air exchange rate and are under negative air pressure,
meaning that the room air has a slight negative pressure compared to
the surrounding rooms. The high air exchange rate (at least 12 air
changes per hour (ACH) for new construction or renovation, 6 ACH
otherwise) helps change the room air frequently and reduces (but does
not eliminate) buildup of airborne disease agents, such as the virus
that causes COVID-19. The negative air pressure differential (0.01 inch
of water [2.5 Pa]) helps reduce the chance that the remaining airborne
virus will exit the room door and contaminate air in adjacent hallways.
An anteroom is a beneficial room feature that helps further isolate the
AIIR from the adjacent hallway. When the AIIR has an anteroom, the
AIIR's air pressure should be negative to the anteroom, while the
anteroom air pressure should be negative to the adjacent hallway. This
arrangement means air from the hallway will flow into the anteroom each
time the door is opened, and air from the anteroom will flow into the
AIIR--minimizing the amount of airborne disease agents (virus) that
exits the room. ASHRAE Standard 170, Ventilation of Health Care
Facilities offers detailed guidance for designing and operating AIIRs
(ASHRAE, 2017).
Maximizing Outside Air Circulated Through HVAC System(s) and the Number
of Air Changes per Hour (ACHs) to the Extent Appropriate
Building HVAC systems are designed to draw in a certain amount of
outdoor air into the building to maintain indoor air quality. By
introducing fresh air into the building, HVAC systems can prevent the
buildup of airborne contaminants through dilution.
The introduction of outdoor air into the building can also help
limit the potential for the virus that causes COVID-19 to accumulate in
the building. The more outdoor air the HVAC system is capable of
drawing into the building, the greater the impact may be on limiting
the potential for the virus to accumulate. Maximizing the amount of
outdoor air introduced to the system can be achieved by fully opening
the building's outdoor air intake dampers; however, this may introduce
other indoor air quality or comfort concerns resulting from humidity,
temperature extremes, or outdoor pollution. Employers should work with
building managers or HVAC professionals to adjust the HVAC system to
bring in as much outdoor air as possible, while taking into
consideration outdoor pollution levels and ensuring that the HVAC
system is capable of maintaining building temperature and humidity
levels within acceptable occupant comfort ranges. OSHA notes that it
does not expect employers to reconfigure duct work to comply with this
provision. When maximizing the outside air, employers should take into
account not to draw in air from potential pollution sources such as
smoking areas, loading docks, vehicle traffic areas, or active
construction zones, or air being re-entrained from the building exhaust
itself.
Balancing refers to the process of measuring the air flow through
the supply ducts and adjusting the dampers to provide an even
distribution of air through the HVAC system duct work and supply vents.
According to ASHRAE Standard 111 Measurement, Testing, Adjusting, and
Balancing of Building HVAC Systems, testing and balancing an HVAC
system provides the means to determine and monitor system performance.
Proper balancing ensures that outdoor air brought into the building
will be evenly supplied to all areas of the building and limit the
potential for ventilation dead zones or stagnant air to accumulate
(ASHRAE, October 31, 2017).
In addition to considering the factors discussed above with respect
to maximizing outside air, employers must also consider how to maximize
ACHs. ACHs are a measure of the air volume that is added to or removed
from a space in one hour divided by the volume of the space. The more
frequently the air within that space is replaced per hour, or the more
ACHs, the more the overall potential concentration of COVID-19 in the
work environment will be reduced. Building owner/operators or employers
can seek assistance from HVAC professionals on maximizing ACHs based on
the workspace and the design capabilities of the HVAC system(s)
(ASHRAE, 2017).
Using Air Filters Rated MERV 13 or Higher, if Compatible With the HVAC
System(s), or, Alternatively, to the Highest Compatible Filtering
Efficiency
Building HVAC systems are equipped with air filters that remove
particles from recirculated air streams before returning the air to
occupied spaces. Air filters are available in a variety of materials
such as pleated paper, cloth, woven fiberglass, and polyester. A
filter's efficiency is measured by the fraction of particles the filter
is able to remove from the air stream. The higher the filter's
efficiency the better it is at removing particles from the air. There
are several systems for rating filter efficiencies. The most common is
the MERV rating system, which was developed by ASHRAE.
Many existing HVAC systems are designed and installed to operate
with filters ranging from MERV 6 to MERV 8. MERV 8 filters are only
about 20 percent efficient in removing particles in the 1 [micro]m to 3
[micro]m size range (the size range of concern for aerosol droplets
containing the virus that causes COVID-19). Employers and building
managers can improve this efficiency by upgrading to MERV 13 or higher
filters, to the extent those filters are currently compatible with
system components (e.g., filter housing slot type, size, and shape).
MERV 13 filters are at least 85 percent efficient at capturing
particles in the 1 [micro]m to 3 [micro]m size range. Increasing filter
efficiency, however, can increase pressure drop across the filters
leading to increased fan energy use, reduced airflow rates, and or/
issues controlling indoor temperature and humidity levels. As a result,
employers and building owners may need to consult an HVAC professional
to optimize filter efficiency consistent with their HVAC system's
capabilities.
Maintaining and Replacing All Air Filters as Necessary
The required frequency for changing filters will vary depending on
the characteristics of the HVAC system, and therefore the ETS does not
specify a frequency for filter changing.
Ensuring All Outside Air Intake Ports Are Clean, Maintained, and
Cleared of Any Debris That May Affect the Function and Performance of
the HVAC System(s)
To comply with this provision, a visual inspection of the outside
air intakes, which can be accomplished as part of a routine maintenance
program, is required.
Additional Ventilation Measures
A note to the ETS's ventilation requirements provides that, in
addition to the requirements for existing HVAC systems and AIIRs, all
employers should also consider other measures to improve ventilation in
accordance with CDC guidance. Below are some additional measures that
an employer should consider to increase total airflow supply to
occupied spaces:
Disabling demand-control ventilation (DCV) controls that
reduce air-supply based on temperature or occupancy;
Using natural ventilation (i.e., opening windows if
possible and safe to do so) to increase outdoor air dilution of indoor
air when environmental conditions and building requirements allow;
Running the HVAC system at maximum outside airflow for 2
hours before and after occupied times;
Generating clean-to-less-clean air movements, re-
evaluating the positioning of supply and exhaust air diffusers and/or
dampers, and adjusting zone supply and exhaust flow rates to establish
measurable pressure differentials;
Requiring that staff work in ``clean'' ventilation zones
and not in higher-risk areas (e.g., visitor reception) to the extent
feasible;
Using portable high-efficiency particulate air (HEPA) fan/
filtration systems to help enhance air cleaning especially in higher-
risk areas; and
Ensuring exhaust fans in restroom facilities are
functional and operating at full capacity when the building is
occupied.
The terms of the ETS make clear that there are no technological
hurdles to compliance with its ventilation requirements. First, the
ventilation requirements apply only to existing systems. A note in the
ETS emphasizes that the requirements do not require installation of new
HVAC systems or AIIRS, or upgrades of existing systems to replace or
augment functioning systems. Therefore, the ventilation requirements do
not raise the questions of feasibility typically associated with
employers needing to install new engineering controls to come into
compliance with a new standard.
Second, the HVAC requirements apply only to employers who own or
control buildings or structures. Thus, for example, the requirements do
not apply to employers who lease space and do not control the building
or structure, and the ETS does not raise questions as to how these
employers would comply with the ventilation requirements.
Third, employers covered by the general section are required only
to ensure that HVAC systems operate with a sufficient filter (MERV-13
where possible) in accordance with manufacturer's instructions and
design specifications, and only in a manner that is appropriate for the
system using methods that are compatible with the system, and that
AIIRs are maintained and operated in accordance with their design and
construction criteria. As such employers are not required by the ETS to
modify their HVAC systems or AIIRs in any manner, only to ensure that
they are operating as designed, which negates questions as to how the
employer would make modifications.
Fourth, a number of the plans, best practice documents, and
scenarios discussed above reference HVAC systems and ventilation. The
use of HVAC systems to manage building air filtration and circulation
of fresh air as part of overlapping controls to address the COVID-19
hazard illustrate that there is no technological feasibility barrier to
compliance with the ETS's ventilation requirements in typical firms in
all affected industries. The ETS's filter requirements are inherently
technologically feasible because they only require the installation of
the
maximum filter that is compatible with the applicable HVAC system.
The design and complexity of HVAC systems can vary widely depending
on a range of factors including the use, size, and age of the building,
and, as discussed, deciding on the maximum appropriate amount of
outside air to circulate through the HVAC system(s) and number of ACHs
can be a complex task. However, larger buildings have dedicated
facilities management staff who are responsible for regular ventilation
system maintenance and adjustment and will have the prerequisite
experience to evaluate the capabilities of the HVAC system, while in
other cases, employers may need to consult with an HVAC professional to
ensure that facilities HVAC is functioning in accordance with the HVAC
manufacturer's instructions and the design specifications of the HVAC
system(s). Based on these factors, OSHA concludes that there are no
technological barriers to compliance with the ETS's ventilation
requirements.
e. Other Provisions
There are no technological feasibility barriers related to
compliance with other requirements in the ETS (e.g., facemasks, and
respirators, cleaning and disinfection, health screening and medical
management, employee notification). Indeed, as explained above, many of
the plans, best practice documents, and scenarios reviewed by OSHA
indicate that these controls have been implemented by employers across
industry sectors as part of a multilayered approach to protecting
workers from the COVID-19 hazard. OSHA highlights a few of the ETS's
other requirements below, but only to point out administrative issues
that will be explored in more depth in other sections of the preamble.
Facemasks. The ETS requires employers to provide, and
ensure that employees wear, facemasks that are FDA-cleared, authorized
by an FDA EUA, or offered or distributed as described in an FDA
enforcement policy. Facemasks that meet these requirements are
currently widely available.
There may be situations where wearing a facemask presents
a hazard to an employee of serious injury or death (e.g., arc flash,
heat stress, interfering with the safe operation of equipment). The
relevant section of the Summary and Explanation provides further
discussion on this topic.
Respirators. As noted in Need for Specific Provisions and
Summary and Explanation (Sections V and VIII of the preamble,
respectively), the increased need for respirators by healthcare workers
during the pandemic has resulted in shortages of N95 filtering
facepiece respirators (FFRs). The ETS addresses these shortages by
encouraging employers to use not only N95 FFRs, but also other
respirators such as elastomeric respirators and powered air-purifying
respirators (PAPRs), where feasible. For further details, see paragraph
(f) of the ETS, as well as relevant sections of Need for Specific
Provisions and Summary and Explanation.
Notification. Paragraphs (l)(2) and (l)(3) of the ETS
contain COVID-19-connected notification requirements for both the
employer and the employee. 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.
There are also no technological barriers to compliance with the
mini respiratory protection program section of the ETS. That section
requires employers, many of whom have never developed or implemented a
respiratory protection program under the Respiratory Protection
standard, 29 CFR 1910.134, to develop and implement one if their
employees wear respirators. However, the mini respiratory protection
program section will require a program that is far less extensive, and
thus easier to comply with, than what is required under 29 CFR
1910.134. For example, the mini respiratory protection program section
will not require quantitative fit testing or medical evaluations
regarding employees' ability to use respirators, both of which are
required under 29 CFR 1910.134. Therefore, OSHA concludes that
compliance with the mini respiratory protection program section does
not raise issues of technological feasibility. OSHA discusses the
administrative cost of complying with the mini respiratory protection
program section in its economic feasibility analysis.
II. Conclusions
OSHA has reviewed the requirements imposed by the ETS and has
determined that achieving compliance with the rule is technologically
feasible for typical operations in the settings that are covered by the
ETS. In reaching this determination, OSHA reviewed evidence that shows
that healthcare-specific good infection control practices are routinely
implemented by employers who have employees in covered settings. This
evidence includes: Readily available CDC infection control guidance
documents, many of which are COVID-19 specific; regulations issued by
the Centers for Medicare & Medicaid Services (CMS), compliance with
which is typically required for accreditation of these settings by The
Joint Commission; and the application of similar requirements in OSHA's
Bloodborne Pathogens Standard, 29 CFR 1910.1030.
OSHA's assessment also analyzed the technological feasibility of
complying with the requirements of the ETS for developing a COVID-19
Plan: Maintaining physical distancing; installing physical barriers;
and ensuring existing ventilation systems are operating as designed. As
noted, the ETS requires employers to develop and implement a COVID-19
plan through a multilayered approach to addressing the spread of COVID-
19 by taking feasible measures to reduce or eliminate the transmission
of COVID-19. This includes requirements for employers to implement
procedures to ensure employees maintain at least 6 feet of physical
distancing from others to the extent feasible and, when distancing is
not feasible, to install physical barriers, again to the extent
feasible. It also allows flexibility in the material of barriers.
OSHA recognizes that sometimes it may not be feasible to implement
either physical distancing or physical barriers for particular work
activities, but even if this is the case, employers must still protect
their employees through the other provisions of the flexible
multilayered approach required by the ETS. The regulatory text allows
for alternatives in some situations, and OSHA has identified a variety
of alternatives that it believes would be technologically feasible in
those situations most of the time. As explained, there are no
technological feasibility barriers related to compliance with
requirements in the ETS for facemasks and respirators, cleaning and
disinfection, health screening and medical management, or employee
notification. Based on the combination of OSHA's evaluation of
technological feasibility of controls in the various scenarios
examined, OSHA finds that the ETS is technologically feasible.
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Garner, J. (1996). Guideline for isolation precautions in hospitals.
The Hospital Infection Control Practices Advisory Committee.
Infection Control and Hospital Epidemiology 17(1): 53-80. https://doi.org/10.1086/647190. (Garner, 1996).
HCA Healthcare. (2021). Our COVID-19 response. https://hcahealthcare.com/covid-19/index.dot. (HCA Healthcare, 2021).
The Joint Commission. (2021a). About our Standards. https://www.jointcommission.org/standards/about-our-standards/. (The Joint
Commission, 2021a).
The Joint Commission. (2021b). Facts about the Joint Commission.
https://www.jointcommission.org/about-us/facts-about-the-joint-commission/. (The Joint Commission, 2021b).
The Joint Commission. (2021c). Accreditation and Certification.
https://www.jointcommission.org/accreditation-and-certification/.
(The Joint Commission, 2021c).
Johns Hopkins Medicine. (2021). Coronavirus (COVID-19) Information
and Updates: COVID-19 Testing and Care. https://www.hopkinsmedicine.org/coronavirus/testing-and-care.html. (Johns
Hopkins Medicine, 2021).
MedStar Health. (2021, May 5). Information from MedStar Health on
COVID-19. https://www.medstarhealth.org/mhs/about-medstar/covid-19-info/. (MedStar, May 5, 2021).
Michigan Medicine, University of Michigan (Michigan Medicine U-M).
(2021, May 18). U-M COVID-19 Preparedness and Response Plan. https://ehs.umich.edu/wp-content/uploads/2020/05/UM-COVID-19-Preparedness-and-Response-Plan.pdf. (Michigan Medicine U-M, May 18, 2021).
Miller, J et al., (2012, January 6).Guidelines for Safe Work
Practices in Human and Animal Medical Diagnostic Laboratories. MMWR
2012; 61(01); 1-101. https://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm. (Miller et al., January 6, 2012).
National Association for Home Care & Hospice (NAHC). (2020, March
3). Guide for Household Members, Intimate Partners, and Caregivers.
https://www.nahc.org/wp-content/uploads/2020/03/Coronavirus-Caregiver-Guide-Customizable.docx. (NAHC, March 3, 2020).
New Mexico EMT Association (NMEMTA). (2020, March 29). Coronavirus
Guidelines. http://www.nmemta.org/CoronavirusGuideline03-29-2020.pdf. (NMEMTA, March 29, 2020).
Rusnak, J et al., (2004, September). Laboratory exposures to
staphylococcal enterotoxin B. Emerging Infectious Diseases, 10(9):
1544-1549. https://doi.org/10.3201/eid1009.040250. (Rusnak et al.,
September 2004).
Santa Clara Valley Medical Center (SCVMC). (2020, December 1).
COVID-19 Exposure, Risk Assessment, Contact Tracing, Testing, and
Return to Work Guidelines for Healthcare Workers (HCWs). https://www.scvmc.org/COVID19/Employee/12012020%20COVID%20Exposure%20Policy.pdf. (SCVMC, December 1, 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).
World Health Organization (WHO). (2016). Guidelines on Core
Components of Infection Prevention and Control Programmes at the
National and Acute Health Care Facility Level. (WHO, 2016).
B. Economic Feasibility
I. Introduction
This section presents OSHA's estimates of the costs, benefits, and
other impacts anticipated to result from the ETS. 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 establishments and industries affected by the
ETS;
Estimate and evaluate the costs and economic impacts that
regulated establishments will incur to achieve compliance with the ETS;
Evaluate the economic feasibility of the rule for affected
industries; and
Estimate the benefits resulting from employers coming into
compliance with the rule in terms of the reduction in COVID-19 disease
and resulting fatalities.
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 a benefit-cost analysis prepared in accordance with E.O.
12866 in that the agency is focused only on costs to employers when
evaluating economic feasibility. In a true benefit-cost analysis, the
costs to all parties (e.g., employees,
governments) are included. Throughout this analysis, there are places
where OSHA estimates there are no costs borne by employers. This does
not necessarily mean that there are no costs or burdens imposed on
others but, from the standpoint of establishing feasibility, these are
not being assessed as part of OSHA's analysis of economic
feasibility.\30\
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\30\ For example, there are places in the analysis where OSHA
specifically accounts for costs being shifted away from employers
through tax credits and other programs aimed at responding to the
pandemic. While the direct costs to employers are reduced for
purposes of evaluating feasibility, those costs would be
attributable to the ETS in a true benefit-cost analysis.
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A standard must be economically feasible in order to be
``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) (Cotton
Dust) (``any standard that was not economically . . . feasible would a
fortiori not be `reasonably necessary or appropriate' under the Act'');
Nat'l Maritime Safety Ass'n v. Occupational Safety & Health Admin., 649
F.3d 743, 752 (D.C. Cir. 2011). 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.
OSHA's evaluation of the overall costs and benefits of the ETS has
been performed for the purposes of complying with requirements outside
of the OSH Act (e.g., Executive Orders 12866 and 13563, the Unfunded
Mandates Reform Act). ``[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 16612, 16622-23 (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.'').\31\
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\31\ 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.
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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.
OSHA has prepared this ETS and the accompanying economic analysis on an
extremely condensed timeline and has complied with E.O. 12866 and E.O.
13563 only to the extent practicable under the circumstances (see Exec.
Order No. 13999, Jan. 21, 2021, 86 FR 7211 (Jan. 26, 2021)). This rule
is an economically significant regulatory action under Sec. 3(f) of
Executive Order 12866 and has been reviewed by the Office of
Information and Regulatory Affairs in the Office of Management and
Budget, as required by executive order.
II. Healthcare 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 29 CFR 1910.502. 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 ETS
The ETS applies to all settings where any employee provides
healthcare or healthcare support services except:
The provision of first aid by an employee who is not a
licensed healthcare provider;
the dispensing of prescriptions by pharmacists in retail
settings;
non-hospital ambulatory care settings where all non-
employees are screened prior to entry and people with suspected or
confirmed COVID-19 are not permitted to enter those settings;
well-defined hospital ambulatory care settings where all
employees are fully vaccinated and all non-employees are screened prior
to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings;
home healthcare settings where all employees are fully
vaccinated and all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not present;
healthcare support services not performed in a healthcare
setting (e.g., off-site laundry, off-site medical billing); or
telehealth services performed outside of a setting where
direct patient care occurs.
In well-defined areas of covered settings where there is no
reasonable expectation that any person with suspected or confirmed
COVID-19 will be present, paragraphs (f), (h), and (i) do not apply to
employees who are fully vaccinated.
Healthcare services are delivered through various means including,
but not limited to: Hospitalization, long-term care, ambulatory care
(e.g., treatment in physicians' offices, dentists' offices, and medical
clinics), home health and hospice care, and emergency medical response.
Healthcare support services include, but are not limited to, patient
intake/admission, patient food services, equipment and facility
maintenance, housekeeping, healthcare laundry services, medical waste
handling services, and medical equipment cleaning/reprocessing
services.
In order to determine which employers are covered by the ETS, OSHA
identified both the occupations where workers would be providing
healthcare and healthcare support services and the setting where those
tasks would be done. For example, a social worker in a hospital may be
working in conjunction with healthcare providers and therefore
providing healthcare or healthcare support services. However, a social
worker working for a children and family services or social advocacy
organization would not be covered by the ETS since neither they nor
anyone else at their organization would be providing healthcare or
healthcare support services.
OSHA's methodology for determining which establishments and
employees are covered by the ETS focuses on job tasks and settings.
OSHA did not assign costs to certain categories of job tasks because
they are excluded from the scope of the ETS by paragraph (a). These
include: Employees who are teleworking; employees who are providing
services via telehealth; employees providing healthcare support
services at off-site locations; employees who are in uncovered portions
of settings (e.g., retail stores with health clinics, schools with
school nurses) that are not fully covered by the ETS; and employees who
work in parts of hospitals that would meet the ambulatory care
exemption in paragraph (a)(2)(iv). Numerous employees of hospitals,
long-term care facilities, and nursing homes are likely to fall into
one of these categories. While these workers are included in Table
VI.B.3 as employees of covered establishments, OSHA has not assigned
employee-based costs to their employers in this analysis.
Furthermore, OSHA has not determined how many non-hospital
ambulatory care providers will screen patients for COVID-19 infections
and symptoms, and therefore be fully exempt from this rule under
paragraph (a)(2)(iii). To the extent that providers meet these
exemption criteria, they will incur no costs for compliance with
respect to these settings. Therefore, for this subset of
establishments, the costs presented in OSHA's analysis will be dramatic
overestimates (i.e., OSHA assumes full costs where costs should be
zero). Overall, however, OSHA believes that the number of workers
estimated to be covered by the ETS is reasonable and leads to
reasonable aggregate estimates of the average costs of compliance for
employers in covered settings.
Table VI.B.1 summarizes the individual North American Industry
Classification System (NAICS) codes, along with OSHA's estimated
percentage of entities and employees, covered by the ETS. The
percentage of entities covered were generally estimated as the
percentage of firms reporting having employees whose occupation would
have them providing healthcare and healthcare support services (see
Appendix VI.B.A). In some healthcare industries (e.g., many of those in
NAICS 62 Health Care and Social Assistance), 100 percent of entities
are estimated to be affected, but for industries outside of the
healthcare sector, no more than 25 percent of entities were estimated
to be covered by the ETS. The percent of employees covered by the ETS
in covered, non-healthcare entities is estimated based on the
percentage of employees in those industries who are reported to be
employed in the occupation categories identified in Appendix VI.B.A.
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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 VI.B.2 presents the states that have OSHA-approved State Plans
and their public entities are included in the analysis.
[GRAPHIC] [TIFF OMITTED] TR21JN21.010
c. Affected Entities and Employees
OSHA used data from the U.S. Census' 2017 County Business Patterns
(CBP) to identify private sector entities and employees, including for-
profit and non-profit entities affected by the ETS (U.S. Census Bureau,
November 21, 2019, U.S. Census Bureau, March, 2020); and uses the
Bureau of Labor Statistics' (BLS) 2017 Quarterly Census of Employment
and Wages (QCEW) to characterize state and local government entities
(BLS, May 23, 2018). For covered public fire departments and
firefighters cross-trained as EMTs, OSHA relied on data from the U.S.
Fire Administration (USFA) National Fire Department Registry (USFA,
2018).
OSHA similarly obtained estimates of the number of employees in
entities from CBP and QCEW. OSHA used the BLS 2018 Occupational
Employment Statistics (OES), which provides NAICS-specific estimates of
employment by occupation, to determine the subset of employees
performing the tasks outlined in the scope of the ETS (BLS, March 29,
2019). Within the affected NAICS industries, OES includes approximately
700 unique occupations. Of these, OSHA identified 90 occupations
representing jobs where workers would perform healthcare or healthcare
support services (see Appendix VI.B.A). OSHA then calculated the
proportion of total employees that these occupations represented for
the NAICS industries that reported employing these occupations in OES
data, and applied those proportions to the CBP and QCEW employee
estimates for the covered entities. This results in an estimate of the
subset of employees by NAICS industry where workers are covered by the
ETS.
For many regulatory economic analyses, the agency uses the most up-
to-date economic data as its baseline to describe the current state of
the economy. It then applies the anticipated changes due to the new
OSHA standard or regulation to that baseline. However, even the most
current data OSHA uses in a typical economic analysis--including
employment, number of establishments, revenue, etc.--represent economic
conditions from at least one calendar year in the past. Even with that
lag in the data due to reporting and compilation time, the idea is that
the basic structure of the economy changes slowly, so the recent past
is a good predictor of the near future.
Given the unique circumstances of the pandemic and its economic
disruption, OSHA's usual approach is inappropriate for the present
analysis. The agency has therefore also made adjustments to the
baseline industry profile to account for the economic conditions that
are expected to persist during the time period in which this ETS will
be in effect. Specifically, OSHA takes the above data as the baseline
for 2019, the last full year before the onset of the pandemic.\32\ Then
the agency adjusted employment and revenue by industry in order to
capture the current adverse conditions and provide better estimates of
employment and revenue both currently and over the period in which the
ETS will be in effect. The detailed methodology for these adjustments
is presented in Appendix VI.B.D.
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\32\ This includes updating revenue numbers for inflation to
2019 using the GDP deflator.
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Table VI.B.3 summarizes the entities and employees covered by the
ETS. OSHA estimates a total of approximately 563,000 entities,
including approximately 749,000 establishments, and approximately 18.1
million total employees who are employed by establishments covered by
the ETS. All affected establishments are assumed to incur the
establishment-based costs of compliance. In addition, OSHA estimates
that there are approximately 10.3 million employees in those
establishments who would not meet any of the exemptions in paragraph
(a) and whose employers would therefore incur per-employee costs of
compliance as well. However, as shown in Table VI.B.3, the portion of
employees for whom OSHA took per-employee costs varies considerably by
NAICS industry.
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d. Affected Small Entities and Employees
While OSHA has determined that it is impracticable to comply fully
with the requirements of the Regulatory Flexibility Act (RFA) (see
Additional Requirements, Section VII of the preamble), the agency has
nevertheless examined the impact of the ETS on small and very small
entities as part of OSHA's analysis of feasibility. There are three
types of small entities under the
RFA: (1) Small businesses; (2) small non-profit organizations; and (3)
small governmental jurisdictions. The Small Business Administration
(SBA) uses characteristics of businesses classified using the NAICS as
a basis for determining whether businesses are small within a given
industry. SBA small entity size criteria vary by industry, but are
usually based on either number of employees or revenue (Table of Small
Business Size Standards (SBA, August 19, 2019)). A small non-profit
organization is any not-for-profit enterprise that is independently
owned and operated and not dominant in its field. A small governmental
jurisdiction is a government of a city, county, town, township,
village, school district, or special district with a population of less
than 50,000.
To determine the number of private SBA-defined small entities, OSHA
relies on 2017 CBP data, which report total revenues by entity and
employment size. For those industries with a revenue criterion, OSHA
calculated the average revenue for each employment size class in the
Census data and identified the largest size class where average revenue
is less than the SBA-defined small entity threshold. For those
industries with employment criterion, OSHA calculated the average
employees per entity by employment size class and included all entities
below the SBA threshold.
To estimate the subset of local government entities that are small,
OSHA uses additional QCEW data that are specified geographically by
county at the 4-digit NAICS level along with 2017 county-level
population data from the U.S. Census Bureau's (December 6, 2018)
American Community Survey. Using these data, OSHA estimates the
percentage of local government entities, by county, that are small
local governments (i.e., in counties with a population less than
50,000), for each affected setting. OSHA then applies these proportions
to the prior national estimates of all local government entities, by
NAICS industry. The RFA's definition of small nonprofits is those not
``dominant in their field.'' As OSHA customarily does, it assumes all
nonprofits are small based on this definition.\33\
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\33\ While the RFA definition suggests that some nonprofits
might not be small entities, there is no set definition for the term
``dominant'' or delineation of what should be considered a
nonprofit's ``field.'' A nonprofit that is the main entity of its
type in a given city is still unlikely to be the dominant nonprofit
of its type in its state or region and even less likely to be
dominant if the ``field'' encompasses the whole U.S. Given these
ambiguities, OSHA has opted to include all non-profits as small
entities.
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Lastly, Table VI.B.5 presents estimates for very small entities
(those with fewer than 20 employees) affected by the ETS. OSHA
estimates that the ETS affects approximately 472,000 very small
entities, employing approximately 2.2
million workers. Of those, approximately 1.2 million are estimated to
be workers who are in scope and covered by the ETS.
[GRAPHIC] [TIFF OMITTED] TR21JN21.013
BILLING CODE 4510-26-C
e. Summary of Affected Firms, Establishments, and Employees by NAICS
Industry and Setting
Table VI.B.6 presents a summary of the number of affected entities,
establishments, and employees by NAICS industry and setting. The cost
estimates presented in this analysis rely on assumptions that are
specific to the type of services provided in various healthcare
settings in each affected NAICS industry. Table VI.B.6 provides the
mapping between the affected NAICS industries and their typical setting
based on the type of services provided.
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[GRAPHIC] [TIFF OMITTED] TR21JN21.015
BILLING CODE 4510-26-C
III. Cost Analysis for the COVID-19 ETS
In this section, OSHA provides estimates of the per-establishment
costs for the requirements of the 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. However, during that
period, to the extent OSHA finds that 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 the ETS, as appropriate.
In developing the cost estimates, OSHA estimates that some
establishments are already following at least some of the ETS's
requirements. The extent to which firms are already meeting the
requirements of this ETS is estimated based, in part, on data presented
in ERG (August 9, 2013), the infectious disease expert panel report
prepared for OSHA. Because the expert panel was conducted pre-pandemic,
OSHA determined that some compliance rates were likely too low given
the heightened awareness of infection control practices, the amount of
time since the pandemic started, and, especially, the outbreaks in
healthcare settings and recognition of the importance of infection
control measures for protecting workers and patients. In those limited
circumstances, OSHA constrained compliance to be no less than 75
percent for large and SBA-defined small entities and 50 percent for
very small entities. Where establishments are already meeting ETS
requirements, those costs are not attributable to the ETS. Throughout
this analysis, where OSHA provides no other estimate, the agency
assumes baseline compliance rates of 50 percent for very small entities
and 75 percent for all other entities.34 35 OSHA recognizes
that the estimated compliance rates are somewhat imprecise, but they
are intended to reflect the relatively widespread adoption by employers
of some of the practices required by the ETS in response to state OSHA
standards, state and local government ordinances, and CDC, OSHA or
other guidance. Exceptions to the 50 percent/75 percent compliance
rates have been made for a few requirements that are highly specific to
OSHA's ETS (like recordkeeping requirements, rule familiarization, and
paid medical removal). While it is likely that levels of current
compliance vary among the elements of this ETS, OSHA lacks data to make
such specific determinations for each provision in the limited time
available under these emergency circumstances. OSHA examined the impact
of lower levels of baseline compliance on costs in a sensitivity
analysis (see section VI.B.III.q).
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\34\ The term ``baseline compliance'' is used to describe
protective workplace measures that would be conducted in the absence
of this ETS, the issuance of which establishes the meaning of and
the parameters for ``compliance.''
\35\ Note that the lower assumed compliance rate for very small
entities sometimes results in the presentation of higher costs for
very small entities than for larger entities. This result seems
counter-intuitive given that very small entities have fewer
employees than larger ones, and many of the costs in this analysis
are based on an average number of employees per entity. The very
small entities do, in fact, have lower costs when baseline
compliance rates are not taken into account. However, because OSHA
estimates that these employers are starting from a lower level of
current compliance, the tables, which incorporate baseline
compliance rates in their estimates, sometimes show higher (or only
negligibly lower) per-establishment costs for very small entities.
Another point on the tables which can seem counter-intuitive is that
average costs per establishment for the category ``all,'' which
includes large and very large entities (along with small and very
small entities) can be smaller (or not much larger) than for, say,
SBA-defined small entities. This is due, again, to the differing
compliance rates which can swamp, in the average, the higher costs
incurred by large and very large entities. Furthermore, because
there are often fewer large entities relative to the number of SBA-
defined small and very small entities in an industry, the average
costs for the smaller entities tend to result in lower average per
entity costs over ``all'' establishments than one might expect.
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Despite this estimated baseline compliance, employer compliance is
not so widespread, nor does it incorporate enough of the practices
required by this ETS, as to render this ETS unnecessary. As discussed
in Section V. Need for Specific Provisions of the ETS, OSHA emphasizes
that each of the infection control practices required by the ETS
provides some protection from COVID-19 by itself, but the controls work
best when used together, layering their protective impact to boost
overall effectiveness. The ``Swiss Cheese Model of Accident Causation''
(Reason, April 12, 1990) argues that each control has certain
weaknesses or ``holes.'' The ``holes'' differ between different
controls. By stacking several controls with different weaknesses on top
of one another, the ``holes'' are blocked by the strengths of the other
controls. In other words, if the controls are layered, then any
unexpected failure of a single control is protected against by the
strengths of other controls. This model also demonstrates the necessity
for high levels of compliance with all requirements of this ETS, since
failure to follow the requirements may leave the ``holes'' exposed and
lead to an increased risk of disease transmission in the workplace.
It should be noted that this analysis deals strictly with averages
and estimates. For any given establishment, 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.
Many ETS requirements result in labor burdens that are monetized
using the labor rates described in Section VI.B.III.a OSHA
differentiates per-establishment burden by establishment size for
large, SBA-defined small, and very small entities with fewer than 20
employees (which are a subset of SBA-defined small entities). In doing
so, OSHA accounts for the fact that, in most industries, a substantial
portion of the SBA-defined small entity population is also very small.
In most cases, OSHA assigned different unit cost burdens to entities
with fewer than 20 employees and to other SBA-defined small entities
(with 20 or more employees). Both of these groups are combined when
calculating average costs for all SBA-defined small entities.
OSHA estimates that approximately 563,000 entities have employees
who provide healthcare and healthcare support services and would be
subject to the requirements of the ETS, including approximately 749,000
establishments, and 10.3 million employees (see Table VI.B.3).
Section VI.B.III.a describes the wage rates used to estimate the
labor costs incurred by affected entities. Sections VI.B.III.b through
VI.B.III.o present the estimated costs for each of the requirements of
the ETS. Finally, section VI.B.III.p summarizes the total per-
establishment costs and total costs of the ETS.
a. Wage Rates
OSHA estimated occupation-specific wage rates from BLS 2018
Occupational Employment Statistics data (BLS, March 29, 2019). For each
affected NAICS industry, OSHA used the BLS (March 29, 2019) data to
estimate the average wages across the workers in the affected
occupations listed in Appendix VI.B.A. OSHA estimated loaded wages
using a fringe benefit rate of 44.4 percent, the average rate for all
civilian workers in the healthcare and social assistance industries in
the BLS (December 14, 2018) Employer Costs for Employee Compensation
data, as well as OSHA's standard estimate for overhead of 17 percent
times the base wage. The loaded wage rate averages by NAICS industry
and setting are presented in Appendix VI.B.B.
In addition to the wages of the healthcare providers and employees
in other covered occupations in the affected NAICS industries, the cost
analysis also uses an estimated wage rate for occupational health
specialists, training development specialists, and a blended wage rate
that reflects the mix of doctors and nurse practitioners.
[GRAPHIC] [TIFF OMITTED] TR21JN21.016
b. Rule Familiarization and COVID-19 Plan
ETS Requirements--Under Sec. 1910.502(c).
The employer must develop, implement, and update a COVID-19 plan
that addresses the hazards identified in the hazard assessment required
by this paragraph. The COVID-19 plan must include policies and
procedures that minimize the risk of transmission of COVID-19 for each
employee. This provision also requires employers to coordinate and
communicate with other employers at sites with multiple employers in
order to ensure that each employee is protected. Employers must have
policies and procedures to ensure that employees who enter into private
residences or other physical locations controlled by those not covered
by the OSH Act are protected. Non-managerial employees must be given
the opportunity to provide input into the hazard assessment and the
COVID-19 plan. The plan must be written if the employer has more than
10 employees. In order for an employer to be exempt from providing
certain controls for fully-vaccinated employees in a well-defined area
of a workplace where there is no reasonable expectation that any person
with suspected or confirmed COVID-19 will be present, the COVID-19 plan
must include policies and procedures to determine employees'
vaccination status.
This section of the feasibility analysis presents the estimated
costs for developing the plan, while the costs of implementing the plan
are presented in the subsequent sections (VI.B.III.c through
VI.B.III.o) of this report.\36\
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\36\ Estimates were based on the Infectious Diseases Panel
Report (ERG, August 9, 2013).
---------------------------------------------------------------------------
Cost Analysis Assumptions
As part of the Infectious Diseases Small Business Advisory Review
(SBAR) Panel, OSHA estimated that the development of a full Worker
Infection Control Plan (WICP) that included written standard operating
procedures for all infectious disease transmission routes would take
between 20 and 40 hours to develop, depending on the setting (OSHA,
2014). For this ETS, which applies specifically to COVID-19, OSHA
estimates that the written plan, including the hazard assessment, would
take 25 percent of the time needed to develop a full WICP. The
exception is hospitals, which are assumed to need 40 hours to develop
their plans. OSHA has not included additional time for employee
participation and assumes that the time estimated to develop the COVID-
19 plan is extensive enough to account for this activity. In addition
to the costs for developing the COVID-19 plan, OSHA assumes that
establishments with fewer than 20 employees will incur a labor burden
of 1 hour for rule familiarization and larger establishments will incur
a labor burden of 1.5 hours for rule familiarization.
OSHA also assumes an additional recurring daily labor burden to
monitor each workplace to ensure the ongoing effectiveness of the
COVID-19 plan. OSHA estimates this will take 10 minutes per day of
labor per large establishment on average, with 5 minutes per day for
SBA-defined small and very small entities. This burden is incurred
daily, seven days a week,\37\ for six months. OSHA notes that
surveillance on the efficacy of an infection control plan is not a
wholly new activity for healthcare settings (CDC, March 15, 2017). The
Core Infection Prevention and Control Practices for Safe Healthcare
Delivery in All Settings from the Healthcare Infection Control
Practices Advisory Committee (the federal advisory committee appointed
to provide advice and guidance to the Department of Health and Human
Services and CDC regarding the practice of infection control in
healthcare settings) includes performance monitoring as one of its core
elements. Specifically, healthcare providers should ``monitor adherence
to infection control practices'' and ``monitor the incidence of
infections . . . to detect transmission of infectious agents in the
facility'' (CDC, March 15, 2017). OSHA estimates that there will be
some additional burden due to the requirements of this ETS, but that it
would be a small amount of additional time added on to what is a
regular activity that would be undertaken regardless of the ETS.
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\37\ To the extent that businesses are open fewer than seven
days a week or do not have employees on the premises seven days a
week, there will be some tendency toward overestimating the cost of
complying with this provision.
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As part of the planning and on-going monitoring, some employers
will need to communicate with other employers whose employees are at
the site (e.g., contractors, vendors) about the specifics of their plan
and additional information as necessary on an on-going basis. OSHA
estimates that hospitals, nursing homes, and other long-term care
facilities will spend 30 minutes one time after the promulgation of
this ETS
to communicate with contractors and others regarding expectations for
their activities under the requirements of this ETS. Additionally, OSHA
estimates that hospitals, nursing homes, and other long-term care
facilities will spend, on average, 15 minutes every week engaging in
on-going communication with contractors under this provision. Other
settings are estimated to only rarely use contractors, and so their
time burden is set to zero for both initial and on-going communication.
The total cost for this communication for hospitals, long-term care
facilities, and nursing homes is a product of:
One-time labor burden (half an hour for applicable settings)
plus the on-going labor burden (0.25 hours weekly for 26 weeks)
Wage rate (NAICS-specific wages)
Cost per Establishment, Rule Familiarization and COVID-19 Plan
Table VI.B.8 presents a summary of the per-establishment rule
familiarization and COVID-19 plan development, daily monitoring, and
host employer communication time burdens and costs for all
establishments. The baseline compliance estimates in Table VI.B.8 are
based on the estimated compliance rates in ERG (August 9, 2013), the
infectious disease expert panel report prepared for OSHA, and adjusted
so that baseline compliance is no less than 50 percent for
establishments with fewer than 20 employees and no less than 75 percent
for larger establishments. The expert panel survey was done during non-
pandemic conditions, so OSHA assumes compliance may be higher in health
care settings today. See the introduction to this section for more
discussion. OSHA assumes zero current compliance for rule
familiarization. Table VI.B.9 presents the same costs as Table VI.B.8
by establishment size.
[GRAPHIC] [TIFF OMITTED] TR21JN21.017
[GRAPHIC] [TIFF OMITTED] TR21JN21.018
c. Patient Screening and Management
ETS Requirements--Under Sec. 1910.502(d)
In settings where direct patient care is provided, employers must
limit and monitor points of entry, screen and triage all non-employees
entering the setting, and implement other applicable patient management
strategies.
Cost Analysis Assumptions
As noted in Summary and Explanation (Section VIII of the preamble),
screening is a standard part of infection control practices. OSHA
expects that healthcare settings will ask about COVID-19 infections and
perform a quick check of existing symptoms or assessment for newly
emerged symptoms that might suggest the presence of a COVID-19
infection. This screening does not need to be a highly involved
procedure and can be completed through verbal questions and answers.
OSHA estimates the six-month incremental time burden per facility for
screening and triaging non-employees for COVID-19 illness and symptoms
of COVID-19 (for all establishments) as follows:
General Hospitals: An incremental burden of 385.1 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 1 patient per employee \38\ and a baseline compliance rate
of 81 percent. [385.1 = (1-0.81) * (666.3/60) * (365/2); where 81% is
the compliance rate, 666.3 is the number of patients (estimated as
being equal to the average number of employees per establishment),\39\
60 is the number of minutes in an hour (which allows OSHA to calculate
the burden in hours per day), and 365/2 is the number of days of
burden]
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\38\ According to AHA Data Hub 2015-2019 data, there were
785,235,256 outpatient visits, 19,418,138 outpatient surgeries, and
34,078,100 admissions in 2019 (AHA, 2021). These data came from
5,141 community hospitals, which results in an average of 447 visits
per day for each hospital. Thus, since OSHA estimates there are 492
healthcare workers per hospital across all types of hospitals, that
is approximately 1 patient per employee per day.
\39\ The estimated average number of workers per hospital for
General Hospitals is greater than the average number across all
types of hospitals derived from the AHA data cited above.
---------------------------------------------------------------------------
Other Hospitals: An incremental burden of 60.4 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 1 patient per employee \38\ and a baseline compliance rate
of 81 percent. [60.4 = (1-0.81) * (104.5/60) * (365/2); where 81% is
the compliance rate, 104.5 is the number of patients (equal to the
average number of employees per establishment), 60 is the number of
minutes in an hour (which allows OSHA to calculate the burden in hours
per day), and 365/2 is the number of days of burden]
Nursing Homes: An incremental burden of 20.4 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 32 patients per facility \40\ and a baseline compliance rate
of 79 percent. [20.4 = (1-0.79) * (32/60) * (365/2); where 79% is the
compliance rate, 32 is the number of patients, 60 is the number of
minutes in an hour (which allows OSHA to calculate the burden in hours
per day), and 365/2 is the number of days of burden]
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\40\ The number of patients per facility for Nursing Homes and
other Long Term Care is estimated using a 2019 National Center for
Health Statistics study on long term care facilities and their
patients (Harris-Kojetin et al., February, 2019) and OSHA's
estimated number of facilities (estimated using BLS (May 23, 2018),
BLS (March 29, 2019), and U.S. Census Bureau (March, 2020)).
---------------------------------------------------------------------------
Long Term Care (excluding nursing homes): An incremental
burden of 14.7 hours is estimated based on a burden of 1 minute per
patient each day for an average of 23 patients per facility
40 and a baseline compliance rate of 79 percent. [14.7 = (1-
0.79) * (23/60) * (365/2); where 79 percent is the compliance rate, 23
is the number of patients, 60 is the number of minutes in an hour
(which allows OSHA to calculate the burden in hours per day), and 365/2
is the number of days of burden]
Other Patient Care: An incremental burden of 39.9 hours is
estimated as 30 minutes per day \41\ and a baseline compliance rate of
56 percent [39.9 = (1-0.56) * (30/60) * (365/2); where 56 percent is
the compliance rate, 30 is the minutes of burden per day, 60 is the
number of minutes in an hour (which allows OSHA to calculate the burden
in hours per day), and 365/2 is the number of days of burden]
---------------------------------------------------------------------------
\41\ The number of patients at hospitals and ambulatory care was
estimated using AHA Data Hub 2015-2019 data (AHA, 2021).
---------------------------------------------------------------------------
Correctional Facility Clinics: An incremental burden of 18.25
hours is estimated as 30 minutes per day and a baseline compliance rate
of 80 percent [18.25 = (1-0.80) * (30/60) * (365/2); where 80 percent
is the compliance rate, 30 is the minutes of burden per day, 60 is the
number of minutes in an hour (which allows OSHA to calculate the burden
in hours per day), and 365/2 is the number of days of burden]
The baseline compliance estimates are based on ERG (August 9,
2013), the infectious disease expert panel report prepared for OSHA. As
noted above, the rate of compliance with the patient screening and
management requirements was estimated to be relatively high prior to
the COVID pandemic. It is possible that these compliance rates are even
higher now, given the emphasis on screening for symptoms over the
course of the pandemic. However, while OSHA has estimated that those
settings that were judged to have very low compliance pre-COVID are
likely complying with screening requirements more thoroughly now, the
agency has not adjusted those settings with higher rates of patient
screening pre-COVID since the agency lacks data to make these
adjustments. The estimated time spent to screen patients is based on
the agency's evaluation of the time necessary to ask standard COVID
screening questions.
Cost per Establishment, Patient Screening and Management
Table VI.B.10 shows the average cost per establishment for patient
screening and management by setting and size and incorporates the
compliance rates as detailed above.
[GRAPHIC] [TIFF OMITTED] TR21JN21.019
d. Standard and Transmission-Based Precautions
ETS Requirements--Under Sec. 1910.502(e)
Employers must develop and implement policies and procedures that
adhere to standard and transmission-based precautions.
Cost Analysis Assumptions
OSHA estimates that any time spent on the development of policies
and procedures that are in accordance with standard and transmission-
based precautions is included in the cost of developing the COVID-19
plan discussed earlier. OSHA does not expect that employers will need
to deviate significantly from existing practice to account for these
precautions and practices, and any costs associated with following
standard and transmission-based precautions are covered under the cost
estimates for the other sections of this ETS (PPE, hygiene and
cleaning, etc.). Therefore, OSHA did not estimate the costs associated
with compliance with this provision separately.
e. Personal Protective Equipment
ETS Requirements--Under Sec. 1910.502(f)
Employers are required to provide facemasks and ensure those
facemasks are worn by each employee over the nose and mouth when
indoors and when occupying a vehicle with other people for work
purposes. Employers must ensure that each employee changes their
facemask at least once per day, whenever the facemask is soiled or
damaged, and more frequently as necessary (e.g., patient care reasons).
Employers must provide respirators and other PPE for workers exposed to
people with suspected or confirmed COVID-19, for employees involved in
aerosol-generating healthcare procedures on people with suspected or
confirmed COVID-19, and as necessary to comply with standard and
transmission-based precautions under paragraph (e). Required PPE
includes gloves, an isolation gown or protective clothing, and eye
protection.
Cost Analysis Assumptions
The total cost to establishments to provide PPE will vary based on
the type of care provided in a facility and the number of encounters
workers will have with patients during a given period. The cost of
implementing this PPE provision will also vary by the number of
employees and the number of patients that the facility sees, as well as
by whether employees are working with people who are suspected or
confirmed to have COVID-19. A small practice with few employees and low
patient volume may have very low costs for PPE while a large hospital
with hundreds of workers and patients on any given day will likely have
much higher costs for PPE.
For the purposes of estimating costs for this provision, OSHA is
assuming that 25 percent of covered employees in hospitals and nursing
homes (which corresponds roughly with the percent of covered workers
estimated to work in areas of a hospital where patients with suspected
or confirmed COVID-19 infections would be seen) and three percent of
in-scope employees in other covered settings (identified in section
VI.B.II.b as being in the scope) will be provided with, and use,
disposable N95 respirators. These estimates are based on OSHA's best
professional judgment. All other workers in covered settings are
estimated to use two disposable facemasks (surgical masks) per shift.
The general approach for estimating the total cost of PPE used by
employees who have exposure to persons with suspected or confirmed
COVID-19 involves the following steps:
1. Estimate the percentage of healthcare providers and employees
providing healthcare or healthcare support services in each setting
that will use each given type of PPE;
2. For each given type of PPE, estimate how many pieces of
equipment an employee will use over six months (e.g., estimate that
hospital workers need 1 N95 respirator per shift, work 3 shifts per
week on average, so they will need 78 N95 respirators over 6 months);
3. Estimate the unit cost for each PPE item; and
4. Calculate the product of (a) the number of covered employees,
(b) the percent that will use a given type of PPE (step 1), (c) the
number of items needed per affected worker over six months (step 2),
and (d) the unit cost (step 3).
Table VI.B.11 presents the estimated percentages of employees who
will need the required PPE by setting.
[GRAPHIC] [TIFF OMITTED] TR21JN21.020
Table VI.B.12 presents estimates for the units of PPE needed per
employee shift for the employees using a given type of PPE. OSHA
assumes that one N95 respirator and either one disposable face shield
\42\ or protective eyewear will be used per shift. The estimated number
of gowns and gloves needed per shift are based on estimates from Carias
et al., (April 10, 2015) and Swaminathan et al., (October, 2007).
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\42\ Employers may provide reusable face shields which may be
less costly on a per-use basis but require cleaning and storage
which are additional costs. As a simplifying assumption, OSHA has
assumed employers will provide disposable face shields which may
represent a source of overestimation of compliance costs.
[GRAPHIC] [TIFF OMITTED] TR21JN21.021
For general hospital, nursing homes, and long-term care facilities,
OSHA estimates that employees work three twelve-hour shifts per week,
or 78 shifts over six months. For other settings, OSHA estimates that
employees work five eight-hour shifts per week, or 130 shifts over six
months. Table VI.B.13 presents the total units of PPE per establishment
that would need to be used over a six-month period, by setting and
worker type. These estimates combine the numbers of covered workers by
setting with the percentages presented in Table VI.B.11, the pieces of
equipment needed from Table VI.B.12, and the number of shifts per
worker that occur over 6 months, and were adjusted for baseline
compliance (80 percent for general hospitals and nursing home
respirator costs, 90 percent for all other PPE in general hospitals and
nursing homes, and 72 percent for other settings).
[GRAPHIC] [TIFF OMITTED] TR21JN21.022
Table VI.B.14 presents the estimated PPE unit costs. Note that
these unit costs reflect typical costs when there is not a PPE
shortage.
[GRAPHIC] [TIFF OMITTED] TR21JN21.023
Cost per Establishment, Personal Protective Equipment
The results from Table VI.B.14 and Table VI.B.13 are combined to
estimate the per-establishment compliance costs of additional PPE
presented in Table VI.B.15.
[GRAPHIC] [TIFF OMITTED] TR21JN21.024
Cost Analysis Assumptions, Respiratory Protection Program
Under this section of the ETS, where employers are required to
provide respirators, they must be provided and used in accordance with
OSHA's Respiratory Protection standard (29 CFR 1910.134). Note that
costs related to optional respirator use under the mini respiratory
protection program (29 CFR 1910.504) are discussed in sections VI.B.IV
and VI.B.V below but are included in the total average costs presented
below in Table VI.B.20 below.
OSHA estimates that 15 percent of nursing home employers and 50
percent of employers in NAICS 621111 Offices of Physicians who do not
currently have a respirator program would either be required by the ETS
to implement a respiratory protection program or would voluntarily
determine that their employees need additional respiratory
protection.\43\ Of those establishments, OSHA estimates that, at most,
25 percent would, as a result of the requirements in this ETS, need to
establish a full program under Sec. 1910.134 and the remainder would
be able to take advantage of the mini respiratory protection program
under Sec. 1910.504 (see section VI.B.IV.b Scope of the Mini
Respiratory Protection section of the ETS below for additional detail).
In establishments that already have a respirator program, OSHA
estimates that the ETS will cause more employees to be wearing
respirators and their employers will incur the additional costs related
to medical evaluation, fit testing, and training for those employees.
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\43\ While OSHA has no hard data on how many establishments have
or will need to develop a respiratory protection program, the agency
has been assisting numerous nursing homes to establish programs over
the course of the pandemic. OSHA expects that some additional
nursing homes and long term care facilities will still need to
establish a program after the promulgation of this ETS but that most
will have done so already. While most offices of physicians would
not have needed a respiratory protection program prior to the
pandemic, OSHA's estimate for this element reflects an assumption
that healthcare providers may decide to be cautious given the close
proximity to others that is required in order to provide healthcare
services.
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In this section, OSHA is evaluating the costs for program
development, medical evaluation, fit testing, and training related to
respiratory protection. As stated above, OSHA is estimating costs
assuming that all affected employees will use disposable N95
respirators only.
Workers who need respiratory protection (i.e., those assumed to be
using N95 respirators) will need to have a medical evaluation, fit
testing, and training. These are one-time costs per affected worker.
That is, total costs are simply calculated as the number of affected
workers multiplied by the one-time per worker cost.
The estimated average numbers of workers per establishment affected
by respiratory protection requirements under the ETS are presented
below in Table VI.B.16.
[GRAPHIC] [TIFF OMITTED] TR21JN21.025
Table VI.B.17 presents the estimated percentage of baseline
compliance with the respiratory protection requirements by setting. The
baseline estimates are based on ERG (August 9, 2013), the infectious
disease expert panel report prepared for OSHA, but as explained in the
introduction to this section, are assumed to be at least 50 percent for
establishments with fewer than 20 employees and at least 75 percent for
larger establishments.
[GRAPHIC] [TIFF OMITTED] TR21JN21.026
The per worker labor burdens and costs include those associated
with the medical examination and the fit testing, which are described
below.
Respiratory Protection Plan Development
The respiratory protection standard requires employers to develop
and maintain a written respiratory protection program. OSHA estimates
that a physician or other licensed healthcare professional will spend 4
hours for establishments with fewer than 20 employees and 8 hours for
larger establishments (OSHA, 2018) to develop this plan.
Medical Evaluation
The Respiratory Protection standard requires employers to provide a
medical evaluation to determine the employee's ability to use a
respirator before the employee is fit tested or required to use the
respirator in the workplace. 29 CFR 1910.134(e)(1); (OSHA, 2018).
While OSHA's respiratory protection standard requires medical re-
evaluation under certain circumstances, OSHA believes that, given the
limited time this ETS will be in effect, there will not be sufficient
time for conditions to change and trigger the requirement for the re-
evaluation and therefore OSHA did not estimate any costs associated
with medical re-evaluation in this analysis.
The preliminary medical evaluation (medical questionnaire) is
estimated to take 15 minutes of the worker's time and 5 minutes of a
physician or other licensed health care professional's (PLHCP) time.
OSHA estimates that a follow-up medical evaluation is needed 23 percent
of the time (OSHA, 2018). When a follow-up medical evaluation is
needed, OSHA estimates that this has a cost of $391 plus the cost
burden for the 1 hour of the worker's time (OSHA, 2018). In addition,
it is estimated that a travel cost of $5 plus a half hour of the
worker's time is incurred for all settings
except for hospitals (since the follow-up is assumed to occur off-site
for employees in settings other than hospitals).
Fit Testing and Training
The Respiratory Protection standard requires that, before a worker
is required to use a respirator with a negative or positive pressure
tight-fitting face piece, the employee must be fit tested with the same
make, model, style, and size of respirator that will be used. Fit
testing costs and training are estimated as one hour of the workers
time, plus one half hour of the fit tester's time for fit testing, one
half hour per 10 employees of the fit tester's time for training, and
the cost of two N95 respirators (OSHA, 2018).
Summary of per Worker Respiratory Protection Costs
Table VI.B.18 summarizes how the per worker respiratory protection
costs are estimated.
[GRAPHIC] [TIFF OMITTED] TR21JN21.027
Cost per Establishment, Respiratory Protection
Table VI.B.19 presents a summary of the respiratory protection
costs per establishment, including plan development, fit testing,
training, and medical evaluation costs.
[GRAPHIC] [TIFF OMITTED] TR21JN21.028
Table VI.B.20 presents a summary of the average per establishment
combined cost for PPE and respiratory protection. The costs included in
Table VI.B.20 also include the costs associated with the
Mini Respiratory Protection Program described in section VI.B.V.0
[GRAPHIC] [TIFF OMITTED] TR21JN21.029
f. Aerosol-Generating Healthcare Procedures on a Person With Suspected
or Confirmed COVID-19
ETS Requirements--Under Sec. 1910.502(g)
When an aerosol-generating procedure is performed on a person with
suspected or confirmed COVID-19, the employer must limit the number of
employees present during the procedure to only those essential for
patient care and procedure support and ensure that the procedure is
performed in an existing airborne infection isolation room (AIIR), if
available. After the procedure is completed, the employer must clean
and disinfect the surfaces and equipment in the room or area where the
procedure was performed.
Cost Analysis Assumptions
Any costs associated with PPE or enhanced cleaning required under
this provision are included in the sections addressing PPE and cleaning
and disinfection. Costs associated with assuring properly functioning
AIIRs are considered in section VI.B.III.j on ventilation, below.
g. Physical Distancing
ETS Requirements--Under Sec. 1910.502(h)
The employer must ensure that each employee is separated from all
other people by at least six feet when indoors unless the employer can
demonstrate that such physical distancing is not feasible for a
specific activity. When six feet of distancing is not feasible, the
employer must ensure that the employees are as far apart as is
feasible. This provision does not apply to momentary exposure while
people are in movement (e.g., passing in hallways or aisles).
Cost Analysis Assumptions
To implement physical distancing requirements, OSHA assumes
employers post signage encouraging physical distancing: 25 Signs on
average per large establishment, with 15 and 10 signs for SBA-defined
small and very small establishments, respectively. OSHA estimated a
unit cost per sign of $0.10, with the assumption that employers will
use free downloadable signs from the CDC and self-print those signs.
OSHA also includes costs for floor markings, based on the unit cost for
a roll of masking tape ($4.39 (Office Depot, 2020)), and assuming 3
rolls per large establishments, 2 rolls per SBA-defined small
establishment, and 1 roll per very small establishments. OSHA also
assumes 2 minutes of labor per sign, including printing and
installation by an employee.
Cost per Establishment, Physical Distancing
Table VI.B.21 presents a summary of the physical distancing costs
per healthcare establishment, incorporating the baseline compliance
rates of 50 percent for very small entities and 75 percent for all
other entities. These include costs of the signs, the floor markings,
and the labor of installing them (calculated using the average loaded
wage shown in Appendix VI.B.B).
[GRAPHIC] [TIFF OMITTED] TR21JN21.030
h. Physical Barriers
ETS Requirements--Under Sec. 1910.502(i)
The employer must install cleanable or disposable, solid barriers
at each fixed work location outside of direct patient care areas where
each employee is not separated from all other people by at least 6
feet. An exception is made for where the employer can demonstrate that
it is not feasible.
Cost Analysis Assumptions
OSHA estimates that the ETS will result in additional clear plastic
barriers installed in 10 percent of general hospital, other hospital,
first aid and emergency care, and other patient care settings. Other
facilities in these settings are assumed to have installed these
barriers or an equivalent barrier prior to the ETS. OSHA estimates that
each setting will install 3 clear plastic barriers with a cost of $300
per barrier.\44\ This is an average. OSHA also assumes 15 minutes of
labor for 2 maintenance workers for the installation of each barrier.
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\44\ The cost of installing clear plastic barriers in response
to COVID-19 has been reported in the following news articles: (1)
Altoona company starts installing plexiglass cashier shields (Lim,
April 2, 2020)--$300 per barrier, and (2) Franklin County to get
prices on spit/sneeze shields, doors (Perry, April 21, 2020)--$140
per barrier. The higher cost estimate is utilized in the analysis.
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While OSHA has no data on the number of barriers that have been
purchased and installed or how many additional barriers will need to be
made, the agency has included what it has determined, based on agency
judgment, to be a reasonable estimate for this requirement. It is
likely that some workplaces will need more barriers than others; it is
also likely that many establishments will reevaluate their current
barrier set up as a result of this ETS and determine that they need
additional barriers. This is an average, so it also accounts for the
likelihood that some establishments will not need any barriers because
the nature of the work makes spacing feasible, or because barriers are
infeasible.
Cost per Establishment, Physical Barriers
Table VI.B.22 presents the average total physical barrier costs for
establishments covered by the ETS by setting and incorporates the
baseline compliance rate of 90 percent as discussed above for
hospitals, first aid and emergency care, and other patient care.
[GRAPHIC] [TIFF OMITTED] TR21JN21.031
i. Cleaning and Disinfection
ETS Requirements--Under Sec. 1910.502(j)
In patient care areas and resident rooms, and for medical devices
and equipment, the employer must follow standard practices for cleaning
and disinfection of surfaces and equipment in accordance with
applicable CDC guidelines. In other areas, the employer must clean
high-touch surfaces and equipment at least once per day. When an
employer is aware that a person who is COVID-19 positive has been in
the workplace within the last 24 hours, the employer must clean and
disinfect any areas, materials, and equipment under the employer's
control that have likely been contaminated by that person. The employer
must also provide alcohol-based hand rub or readily accessible hand
washing facilities.
Cost Analysis Assumptions
In settings other than hospitals, nursing homes, and long-term care
facilities, OSHA assumes establishments will, in addition to their
current cleaning product purchases, need to purchase a six-month supply
of multipurpose cleaners and disinfectants, at a cost of $4.54 for each
(i.e., a supply of multipurpose cleaner and a supply of disinfectants/
virucides), for a total of about $9 per establishment (W.B. Mason,
2020).
Hospitals are estimated to spend a total of $56 million annually on
soaps and cleaning products, and nursing homes and long-term care
settings are estimated to spend $60 million annually on these supplies
(BEA, November, 2018). OSHA estimates that spending on cleaning
products will increase by 5 percent as a result of the ETS, and
accounts for these increased cleaning product costs on a per employee
basis, which is equivalent to an additional $0.37 per hospital employee
and an additional $0.69 per nursing home and long-term care setting
employee. This increased spending also covers the costs of cleaning
associated with aerosol-generating procedures under paragraph (g) of
the ETS.
OSHA expects that the majority of cleaning that would need to be
done to comply with this provision is already being done in response to
CDC guidelines or could be completed in nonproductive downtime without
affecting worker productivity. Given the emphasis on cleaning and
disinfection in healthcare settings (those in NAICS 622), the agency
believes that all necessary cleaning is being done at healthcare
establishments. However, outside of NAICS 622, OSHA has included a time
burden of 2 additional minutes per shift for 25 percent of covered
workers, for cleaning, in order to err on the side of being overly
inclusive of costs.
This provision of the ETS also requires that the employer provide
alcohol-based hand rub (ABHR) or readily accessible hand washing
facilities. OSHA estimates that this ETS will result in a 10 percent
increase in the use of ABHR or an average incremental increase of
0.0067 ounces \45\ of hand sanitizer per use of ABHR (assumed to be 10
percent of the ABHR needed per use, which translates into a 10 percent
increase in use overall), with an estimated incremental cost of 0.335
cents per use.\46\ The estimated number of uses of ABHR is based on the
estimate for the number of gloves used (see Table VI.B.13), assuming
that there are two ABHR uses per pair of gloves used (i.e., using ABHR
before putting on and after taking off each pair of gloves).
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\45\ According to the makers of Purell, ``If used as directed,
which is to apply enough PURELL[supreg] Hand Sanitizer to thoroughly
cover hands, a consumer can get 29-30 uses out of a 2 fl. oz.
bottle''. Thus, OSHA assumes that each use of hand sanitizer would
be 2/30 = 0.067066667 fl oz. (GOJO US, 2020). Ten percent of
0.067066667 fl oz, is 0.0067 fl oz, which is the incremental
increase in ABHR use per use assumed to be attributable to the rule.
\46\ The cost of bulk hand sanitizer is estimated as $0.50 per
ounce (W.B. Mason, 2020).
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Cost per Establishment, Cleaning and Disinfection
Table VI.B.23 presents the average cleaning and disinfection costs
for healthcare establishments by setting and establishment size and
incorporates the baseline compliance rates of 50 percent for very small
entities and 75 percent for all other entities.
[GRAPHIC] [TIFF OMITTED] TR21JN21.032
j. Ventilation
ETS Requirements--Under Sec. 1910.502(k)
Employers who own or control buildings or structures with an
existing heating, ventilation, and air conditioning (HVAC) system, must
ensure that: The system is used in accordance with the manufacturer's
instructions and the design specifications; the amount of outside air
circulated through the system and the number of air changes per hour
are maximized to the extent appropriate; air filters are rated Minimum
Efficiency Reporting Value (MERV) 13 or higher, if compatible, or the
highest compatible filtering efficiency for the HVAC system(s); air
filters are maintained and replaced as needed; and intake ports are
cleaned, maintained, and cleared of debris. This provision does not
require installation of new HVAC systems or AIIRs to replace or augment
functioning systems. However, where an employer has an existing AIIR,
the AIIR must be maintained and operated in accordance with its design
and construction criteria. The regulatory text does include a note
encouraging additional ventilation measures; however, as they are not a
mandatory component of the ETS, costs have not been taken for those
additional measures.
Cost Analysis Assumptions
For all settings, OSHA assumes each establishment will need an
average of 3 MERV 13 air filters for large establishments, with 2 for
SBA-defined small businesses, and 1 for very small establishments. The
unit cost is $21.50 per filter (Home Depot, 2020).\47\ OSHA assumes
filters are replaced every three months, and this replacement requires
10 minutes of labor per filter for an Installation, Maintenance, and
Repair (SOC 49-0000) employee every three months. For hospitals with 20
or more employees OSHA assumed that a larger filter would be used, with
a unit cost of $79 (HD Supply, 2021) and a replacement labor burden of
20 minutes of labor per filter.
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\47\ Employers will need to upgrade to the highest efficiency
filter compatible with their existing system. To the extent
employers are upgrading to something less efficient than a MERV 13
filter, there will be some tendency toward overestimating costs.
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While it is a good business practice to maintain the HVAC system in
good working order and OSHA believes that most establishments have HVAC
systems that meet the requirements of the ETS, OSHA estimates that some
small amount will need to have their HVAC systems serviced. In addition
to the cost of purchasing and installing new air filters, OSHA
estimates that large hospitals, nursing homes, and long-term care
settings will require four hours of a general maintenance and repair
worker's time to evaluate the condition of the HVAC system and to
complete any necessary maintenance. In all other settings, 30 percent
of large employers who need this maintenance will need 2 hours of
maintenance work and SBA-defined small employers who need this
maintenance will need 1 hour of maintenance work. OSHA assumes that
very small entities will be less likely to control the HVAC system in
their facility and therefore assigns no additional maintenance costs to
those establishments. Any necessary HVAC work could be done by an
outside source like an HVAC maintenance contractor or could be done by
in-house maintenance workers if they are available.
The draft infectious disease cost analysis prepared for SBREFA
included engineering control costs for hospitals to maintain AIIRs to
manufacturer's specifications (OSHA, 2014). These costs were updated to
current dollars for the analysis of this ETS. And while the infectious
disease cost analysis included both initial costs and annual
maintenance costs, since the ETS is only effective for six months, OSHA
included in this analysis only maintenance costs to bring existing
AIIRs up to the manufacturer's specifications where they are not
already being maintained properly. OSHA estimates that most hospitals
(83 percent) that have AIIRs properly maintain them (ERG, August 9,
2013).
Based on analyses performed in conjunction with OSHA's (1997)
proposed rule addressing occupational exposure to tuberculosis, 64 FR
54160 (Oct. 17, 1997), the agency estimates that there would be a one-
time cost of $8,143 to perform maintenance on an AIIR so that it
functions properly (e.g., maintains negative air pressure relative to
the surrounding areas, completes the recommended number of hourly air
exchanges) (WCG, November 14, 1994; updated to 2020 dollars). This is
based on an estimated cost per square foot to purchase and install
material, including ducting, fans, and HEPA filters, in an average
isolation room measuring 150 square feet (WCG, November 14, 1994;
updated to 2020 dollars). Note that since the analysis timeframe is 6
months, there are no on-going maintenance costs attributable to the
ETS.
Cost per Establishment, Ventilation
Table VI.B.24 presents the average ventilation costs for healthcare
establishments by setting and size. These estimates incorporate the
baseline compliance rates of 50 percent for very small entities and 75
percent for all other entities, and a baseline compliance rate of 83
percent for maintenance of AIIRs in hospitals.
[GRAPHIC] [TIFF OMITTED] TR21JN21.033
k. Health Screening and Medical Management
ETS Requirements--Under Sec. 1910.502(l)
The employer must screen each employee before each work day or
shift for COVID-19 symptoms and require employees to promptly notify
the employer when they are COVID-19 positive, have been told by a
healthcare provider that they are suspected to be COVID-19 positive, or
are experiencing certain specified symptoms of COVID-19. When an
employer is notified that a person who has been in the workplace is
COVID-19 positive, the employer must notify each employee who had, and
other employers whose employees had, close contact with that person in
the workplace. The employer must also notify any employee who worked
in, and any other employers whose employees worked in, a well-defined
portion of a workplace in which the COVID-positive person was present
during the potential transmission period.
This paragraph also contains a requirement that the employer
immediately remove any employee who is positive for COVID-19. Removal,
which in the ETS refers to temporary removal from the workplace, must
continue until that employee meets the criteria for return to work. In
addition, the employer must remove any employee who has been told by
their healthcare provider that they are suspected to have COVID-19 and
any employee who is experiencing certain COVID-19 symptoms. The
employer must ensure that any such employee is kept out of the
workplace until they either meet the return to work criteria or they
test negative for COVID-19 based on a polymerase chain reaction (PCR)
test, which the employer must provide at no cost to the employee. In
addition, the employer must remove any employee who has had close
contact with someone in the workplace who is COVID-19 positive (unless
the employee has either been fully vaccinated or has recently recovered
from COVID-19). Employees who had close contact must be removed for 14
days or until they test negative for COVID-19 via a test provided at
least 5 days after the exposure and paid for by the employer. Employees
who had symptoms or were informed by a licensed healthcare provider
they are suspected to have COVID-19, but did not have close contact,
can return to work immediately if they test negative. Employees removed
because of close contact must stay away from work for at least 7
calendar days from the date of exposure, even if they test negative.
When an employee is removed under the above criteria the employer
must continue to pay the employee's normal earnings, as though the
employee were still at their regular job, up to $1,400 a week for the
first two weeks. If employees remain sick after that first two-week
period and must stay out longer, employers with fewer than 500
employees are only required to pay two thirds of regular pay, up to
$200 per day, after the initial 10 working days. Pay during removal can
be offset with any employer or public benefits, such as paid leave or
workers' compensation, until the employee meets the return to work
criteria.\48\ The requirement to pay the employee terminates if the
employer offers a COVID-19 test at least five days after the exposure
and the employee refuses to take it. Employers may also require
employees who are removed from the workplace under this paragraph to
work remotely or in isolation when suitable work is available. These
employees would be paid as usual for their work. Employers with 10 or
fewer employees are required to remove employees from the workplace
under this paragraph but are not required to pay them during the time
they are removed.
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\48\ Recent legislation, the American Rescue Plan Act, Public
Law 117-2, section 9641, extends tax credits to many employers for
paid leave provided to employees through September 30, 2021 for
COVID-19 related reasons. These tax credits will cover leave
provided to employees removed from work under this ETS. This reduces
costs to employers by shifting those costs to taxpayers.
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The ETS does not require notification or removal of employees who
were wearing respirators, along with other required PPE, at the time
they had close contact with a person with COVID-19. In addition, an
employee's close contact with a patient with COVID-19 does not trigger
the notification requirements (and therefore does not trigger removal
requirements) if the patient with COVID-19 was in an area where such
patients are normally expected, such as an emergency room or COVID-19
clinic (as opposed to a maternity unit of a hospital, a physician's
office that screens out COVID-19 patients, a physical therapist's
office, etc.).
Cost Analysis Assumptions
The health screening activities could include instructing employees
to perform a self-assessment for symptoms before they arrive to work.
The training on the elements of this self-assessment are included under
the cost of training and there is no cost to the employer for this
activity because it can be completed by the employee concurrent with
other
daily activities without taking time from those activities. Although
employers are not required to use temperature screening for employee
screening, OSHA assumes for purposes of this analysis that this may be
done as part of screening and estimates that it will take an average of
15 seconds per employee per day. OSHA also estimates that
establishments will purchase no-touch thermometers at a rate of 1 per
100 employees, on average, with a minimum of 1 per establishment and
unit cost of $29.50 per thermometer (Rice et al., December 18, 2020).
OSHA also includes 5 minutes of General and Operations Manager (OES
11-1020) labor per case (i.e., each employee required to notify their
employer) to make arrangements for the employee per above, and an
additional 40 minutes per case to notify other potentially exposed
employees. This includes the time to identify which of the exposed
employees would be excluded from the notification and removal
requirements because they were wearing respirators and required PPE at
the time of the exposure.
Cost per Establishment, Health Screening and Notification
In order to estimate the feasibility of the ETS and due to the
highly uncertain path of the pandemic over the period this ETS will be
in effect, OSHA examined feasibility based on historic numbers of cases
and fatalities from two periods: March 19, 2021 through April 19, 2021,
inclusive of the cases on the start and end dates (designated as the
``primary'' scenario) and a monthly average over April 1, 2020 through
April 1, 2021
