[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Rule Proposal]
[Pages 69740-69751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-0015]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2015-0015]


Additional PortaCount Quantitative Fit-Testing Protocols: Amendment 
to Respiratory Protection Standard

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of proposed rulemaking; request for comments.

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SUMMARY: 
OSHA is proposing to add two modified PortaCount® quantitative
fit-testing protocols to its Respiratory Protection Standard. The proposed 
protocols would apply to employers in general industry, shipyard employment, 
and the construction industry. Both proposed protocols are variations of the 
existing OSHA-accepted PortaCount® protocol, but differ from it by the 
exercise sets, exercise duration, and sampling sequence. If approved, the 
modified PortaCount® protocols would be alternatives to the existing 
quantitative fit-testing protocols already listed in an appendix of the 
Respiratory Protection Standard. In addition, OSHA is proposing to amend an 
appendix to clarify that PortaCount® fit test devices equipped with the 
N95-Companion™ Technology are covered by the approved PortaCount® 
protocols.

DATES: 
Submit comments to this proposal, including comments to the information 
collection (paperwork) requirements, by December 6, 2016.

ADDRESSES:
Written comments. You may submit comments, identified by Docket No. 
OSHA-2015-0015, by any of the following methods:

Electronically: You may submit comments and attachments electronically at 
http://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow 
the instructions online for making electronic submissions.
Fax: If your submissions, including attachments, are not longer than 10 pages, 
you may fax them to the OSHA Docket Office at (202) 693-1648.

Mail, hand delivery, express mail, messenger, or courier service: You must 
submit your comments to the OSHA Docket Office, Docket No. OSHA-2015-0015, U.S. 
Department of Labor, Room N-2625, 200 Constitution Avenue NW., Washington, DC 
20210, telephone (202) 693-2350 (OSHA's TTY number is (877) 889-5627). 
Deliveries (hand, express mail, messenger, or courier service) are accepted 
during the Department of Labor's and Docket Office's normal business hours, 
8:15 a.m.-4:45 p.m., ET.

Instructions: All submissions must include the Agency name and the docket 
number for this rulemaking (Docket No. OSHA-2015-0015). All comments, 
including any personal information you provide, are placed in the public 
docket without change and may be made available online at http://www.regulations.gov. 
Therefore, OSHA cautions you about submitting personal information such as 
social security numbers and birthdates.

If you submit scientific or technical studies or other results of scientific 
research, OSHA requests (but does not require) that you also provide the 
following information where it is available: (1) Identification of the funding 
source(s) and sponsoring organization(s) of the research; (2) the extent to 
which the research findings were reviewed by a potentially affected party prior 
to publication or submission to the docket, and identification of any such 
parties; and (3) the nature of any financial relationships (e.g., consulting 
agreements, expert witness support, or research funding) between investigators 
who conducted the research and any organization(s) or entities having an interest 
in the rulemaking. If you are submitting comments or testimony on the Agency's 
scientific and technical analyses, OSHA requests (but does not require) that you 
disclose: (1) The nature of any financial relationships you may have with any 
organization(s) or entities having an interest in the rulemaking; and (2) the 
extent to which your comments or testimony were reviewed by an interested party 
prior to its submission. Disclosure of such information is intended to promote 
transparency and scientific integrity of data and technical information submitted 
to the record. This request is consistent with Executive Order 13563, issued on 
January 18, 2011, which instructs agencies to ensure the objectivity of any scientific 
and technological information used to support their regulatory actions. OSHA 
emphasizes that all material submitted to the rulemaking record will be considered 
by the Agency to develop the final rule and supporting analyses.

Docket: To read or download comments and materials submitted in response to this 
Federal Register notice, go to Docket No. OSHA-2015-0015 at 
http://www.regulations.gov or to the OSHA Docket Office at the address above. 
All comments and submissions are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted material) 
is not publicly available to read or download through that Web site. All comments 
and submissions are available for inspection and, where permissible, copying at 
the OSHA Docket Office.

Electronic copies of this Federal Register document are available at 
http://www.regulations.gov. Copies also are available from the OSHA Office of 
Publications, Room N-3101, U.S. Department of Labor, 200 Constitution Avenue 
NW., Washington, DC 20210; telephone (202) 693-1888. This document, as well as 
news releases and other relevant information, is also available at OSHA's Web 
site at http://www.osha.gov.

FOR FURTHER INFORMATION CONTACT:
For general information and press inquiries, contact Frank Meilinger, Director, 
Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 
Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1999; email 
Meilinger.francis2@dol.gov. For technical inquiries, contact Natalia Stakhiv, 
Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. Department of 
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2272; 
email stakhiv.natalia@dol.gov.

SUPPLEMENTARY INFORMATION:
Table of Contents

I. Background
II. Summary and Explanation of Proposal
III. Issues for Public Comment
IV. Procedural Determinations
V. References
I. Background

Appendix A of OSHA's Respiratory Protection Standard, 29 CFR 1910.134, 
currently includes four quantitative fit-testing protocols using the following 
challenge agents: A non-hazardous generated aerosol such as corn oil, 
polyethylene glycol 400, di-2-ethyl hexyl sebacate, or sodium chloride; ambient 
aerosol measured with a condensation nuclei counter (CNC), also known as the 
standard PortaCount® protocol; controlled negative pressure; and controlled 
negative pressure REDON. Appendix A of the Respiratory Protection Standard also 
specifies the procedure for adding new fit-testing protocols to this standard. 
Under that procedure, if OSHA receives an application for a new fit-testing 
protocol meeting certain criteria, the Agency must commence a rulemaking 
proceeding to consider adopting the proposal. These criteria include: (1) 
A test report prepared by an independent government research laboratory 
(e.g., Lawrence Livermore National Laboratory, Los Alamos National Laboratory, 
the National Institute for Standards and Technology) stating that the laboratory 
tested the protocol and found it to be accurate and reliable; or (2) an article 
published in a peer-reviewed industrial-hygiene journal describing the protocol 
and explaining how the test data support the protocol's accuracy and reliability. 
OSHA considers such proposals under the notice-and-comment rulemaking procedures 
specified in section 6(b)(7) of the Occupational Safety and Health Act of 1970 
(the "Act") (29 U.S.C. 655(b)(7)). Using this procedure, OSHA added one fit-testing 
protocol (i.e., the controlled negative pressure REDON quantitative fit-testing 
protocol) to appendix A of its Respiratory Protection Standard (69 FR 46986, 
Aug. 4, 2004).

In 2006, TSI Incorporated (hereinafter referred to as TSI) submitted two 
quantitative fit-testing protocols for acceptance under the Respiratory 
Protection Standard. OSHA published a notice of proposed rulemaking (NPRM) 
for those protocols on January 21, 2009 (74 FR 3526-01). The proposed protocols 
used the same fit-testing requirements and instrumentation specified for the 
standard PortaCount® protocol in paragraphs (a) and (b) of Part I.C.3 of 
appendix A of the Respiratory Protection Standard, except:

Revised PortaCount® QNFT protocol 1 reduced the duration of the eight 
fit-testing exercises from 60 seconds to 30 seconds; and

Revised PortaCount® QNFT protocol 2 eliminated two of the eight 
fit-testing exercises, with each of the remaining six exercises having a 
duration of 40 seconds; in addition, this proposed protocol increased the 
minimum pass-fail fit-testing criterion (i.e., reference fit factors) from 
a fit factor of 100 to 200 for half masks, and from 500 to 1000 for full 
facepieces. 

OSHA withdrew the NPRM on January 27, 2010 (75 FR 4323-01). 
In withdrawing the NPRM, the Agency concluded that the study data failed 
to adequately demonstrate that these protocols were sufficiently accurate 
or as reliable as the quantitative fit-testing protocols already listed in 
appendix A. OSHA found that the studies submitted with the application did 
not differentiate between results for half-mask and full-facepiece respirators. 
OSHA also determined that TSI had not demonstrated that these protocols would 
accurately determine fit for filtering facepiece respirators.

II. Summary and Explanation of the Proposal

A. Introduction

One of the OSHA-accepted quantitative fit test protocols listed in appendix A 
is the standard PortaCount® protocol. The standard PortaCount® protocol 
and instrumentation was introduced by TSI in 1987, and the use of the standard 
PortaCount® protocol was originally allowed by OSHA under a compliance 
interpretation published in 1988, until it was incorporated into appendix A in 1998.

In a letter dated July 10, 2014, Darrick Niccum of TSI submitted an application 
requesting that OSHA approve three additional PortaCount® quantitative fit 
test protocols to add to appendix A (TSI, 2014a). These three additional protocols 
are modified versions of the standard PortaCount® protocol. Mr. Niccum included 
a copy of three peer-reviewed articles from the industrial-hygiene journal, entitled 
Journal of the International Society for Respiratory Protection, describing the 
accuracy and reliability of these proposed protocols (Richardson et al., 2013; 
Richardson et al., 2014a; Richardson et al., 2014b). The application letter also 
included a copy of the ANSI/AIHA Z88.10-2010 standard (ANSI/AIHA, 2010) and a 
discussion about how the ANSI/AIHA Z88.10-2010, Annex 2 methodology was utilized 
by TSI to conduct a statistical comparison of fit test methods.

For consistency with the terminology used in the three peer-reviewed articles, 
OSHA will, in this section of the NPRM (i.e., Summary and Explanation of the Proposal), 
refer to the three new modified PortaCount® protocols as "Fast-Full method" for 
full-facepiece elastomeric respirators, "Fast-Half method" for half-mask elastomeric 
respirators, and "Fast-FFR method" for filtering-facepiece respirators (FFR). It should 
be noted that the "Fast-Full" method and the "Fast-Half" method are identical protocols, 
but were evaluated for method performance separately in two peer-reviewed articles. 
Since TSI's "Fast-Full" and "Fast-Half" methods are identical protocols, OSHA is proposing 
that only two new protocols be added to appendix A: A modified PortaCount® protocol 
for both full-facepiece and half-mask elastomeric respirators and a modified 
PortaCount® protocol for filtering-facepiece respirators.

All three of TSI's modified PortaCount® protocols use the same fit-testing 
requirements and instrumentation specified for the standard PortaCount® protocol 
in paragraphs (a) and (b) of Part I.C.3 of appendix A of the 
Respiratory Protection Standard, except that they differ from the standard PortaCount® 
protocol by the exercise sets, exercise duration, and sampling sequence. The major 
difference between the proposed Fast-Full and Fast-Half methods and the standard 
PortaCount® protocol is they include only 3 of the 7 current test exercises (i.e., 
bending, head side-to-side, and head up-and-down) plus a new exercise 
(i.e., jogging-in-place), and reduce each exercise duration, thereby reducing the total 
test duration from 7.2 minutes to 2.5 minutes. The peer-reviewed articles describe studies 
comparing the fit factors for the new modified PortaCount® protocols to a reference 
method based on the American National Standards Institute (ANSI/AIHA) Z88.10-2010 
Annex A2 "Criteria for Evaluating New Fit Test Methods" approach. This approach requires 
the performance evaluation study administer sequential paired tests using the proposed 
fit-test method and reference method during the same respirator donning.

B. Evaluation of Fast-Half Method

1. STUDY METHODS

The peer-reviewed article entitled "Evaluation of a Faster Fit Testing Method for 
Elastomeric Half-Mask Respirators Based on the TSI PortaCount®," appeared in a 
2014 issue (Volume 31, Number 1) of the Journal of the International Society for 
Respiratory Protection (Richardson et al., 2014a). The study authors selected three 
models of NIOSH-approved, half-mask air-purifying respirators from "leading U.S. 
mask manufacturers" equipped with P100 filters. Each model was available in three sizes. 
Respirators were probed with a flush sampling probe located between the nose and mouth. 
Twenty-five participants (9 female; 16 male) were included in the study; face sizes were 
predominantly in the smaller and central cells (1, 2, 3, 4, 5, 7, 8) of the NIOSH 
bivariate panel; no subjects were in cells 6, 9 or 10 (those with longer-nose to 
chin-face sizes).

Test subjects donned the respirator for a five-minute comfort assessment and then 
performed two sets of fit-test exercises, either using the Reference method or the 
Fast-Half method. The order of the two sets of fit-test exercises was randomized. 
The Reference method consisted of the eight standard OSHA exercises listed in Section 
I.A.14 of appendix A of the Respiratory Protection Standard, minus the grimace exercise, 
in the same order as described in the standard (i.e., normal breathing, deep breathing, 
head side-to-side, head up-and-down, talking, bending over, normal breathing). 
Each exercise was performed for 60 seconds.

According to TSI, the study authors chose not to include the grimace exercise because 
little or no support was found for the grimace exercise among respirator fit-test 
experts (TSI, 2015a). TSI explained that "[t]he most common fault expressed by a number 
of experienced fit testers and industry experts was that the grimace cannot be 
consistently applied or even defined (TSI, 2015a)." They further commented that 
the grimace is intended to break the face seal and may not reseal in the same way 
for subsequent exercises. As a result, the shift in the respirator can potentially 
confound comparison of the fit-test methods. TSI also noted that the fit factor from 
the grimace (if measured) is not used to calculate the overall fit factor test result 
under the standard PortaCount® method (TSI, 2015a).

The Fast-Half method included four exercises-bending, jogging in place, head 
side-to-side and head up-and-down. Two breaths were taken at each extreme of the 
head side-to-side and head up-and-down exercises and at the bottom of the bend in 
the bending exercise.

Although not discussed in the peer-reviewed journal article, TSI explained their 
rationale for selecting the exercises that were the most rigorous for (i.e., the best at) 
identifying poor fitting respirators in two documents submitted to the Agency 
(TSI, 2014b; TSI, 2015a). TSI selected the exercises based on a literature review, 
informal conversations with industry fit test experts, and in-house pilot studies. 
"Talking out loud," "bending," and "moving head up/down" were determined to be the 
three most critical exercises in determining the overall fit factor for abbreviated 
respirator fit test methods by Zhuang et al. (Zhuang et al., 2004). TSI's in-house 
pilot collected fit-test data on subjects using consecutive sets of the seven-exercise 
Reference method described above (TSI, 2014b). TSI analyzed the frequency with which 
each exercise produced the lowest fit factor. Fit test data was separated into three 
groups: All fit tests, good-fitting fit tests, and poor-fitting fit tests. A 
poor-fitting fit test was defined as any test where at least one exercise failed. 
The results showed that normal breathing, deep breathing, and talking rarely produced 
the lowest fit factor (frequency <e;3 percent) for poor-fitting full-facepiece 
respirators. On this basis, these three less rigorous exercises were eliminated 
for both the Fast-Full and Fast-Half methods. The bending exercise was the most 
rigorous exercise for poor-fitting full-facepiece and half-mask elastomeric respirators. 
Talking was the exercise that most often had the lowest fit factor for good-fitting 
full-facepiece and half-mask respirators in the pilot study. None of the other 
exercises stood out for half-mask respirators, but TSI reasoned that there was a 
lack of data suggesting that half-mask respirator fit tests should use different 
exercises than full-facepiece respirators (TSI, 2015a). The study added 
jogging-in-place for a fourth rigorous test exercise as part of the protocol. 
Jogging is an alternate (i.e., elective as opposed to required) exercise in 
Annex 2-"Criteria for Evaluating New Fit Test Methods of the Respiratory Protection" 
of the ANSI/AIHA Z88.10-2010 standard.

A single CPC instrument, PortaCount® Model 8030 (TSI Incorporated, Shoreview MN), 
was used throughout the Fast-Half method validation experiments. The instrument 
was connected to two equal-length sampling tubes for sampling inside-facepiece 
and ambient particle concentrations. TSI software was used to switch between 
sampling lines and record concentration data. The experiments were conducted in a 
large chamber to which a NaCl aerosol was added to augment particle concentrations, 
which were expected to range between 5,000 and 20,000 particles/cm3 
(target = 10,000 p/cm3).

During the Reference method, for each exercise, the ambient sampling tube was 
first purged for 4 seconds before an ambient sample was taken for 5 seconds, 
followed by an 11-second purge of the in-facepiece sampling tube and a 40-second 
in-facepiece sample. The Reference method took a total of 429 seconds 
(7 minutes 9 seconds) to complete.

During the first exercise of the Fast-Half method (bending over), the ambient 
sampling tube was first purged for 4 seconds before an ambient sample was taken 
for 5 seconds; the in-facepiece sampling tube was then purged for 11 seconds and 
a sample was then taken from inside the mask for 30 seconds. No ambient sample 
was taken during the next two exercises (jogging and head side-to-side)-just 
one 30-second in-facepiece sample was collected for each exercise. For the last 
exercise (head up-and-down), a 30-second in-facepiece sample was taken, after 
which a 4-second ambient purge and 5-second ambient sample were conducted. The 
Fast-Half method took a total of 149 seconds (2 minutes 29 seconds) to complete.

For the Reference method, the authors calculated a fit factor for each exercise 
by dividing the in-facepiece concentration taken during 
that exercise by the mean ambient concentration for that exercise (average of 
the ambient measurements pre- and post-exercise). The overall fit factor was 
determined by taking a harmonic mean of the seven exercise fit factors.

For the Fast-Half method, the ambient concentration was calculated by taking 
the mean of two measurements-one before the first exercise and one after the 
last exercise. The authors calculated fit factors for each exercise by 
dividing the in-facepiece concentration taken during that exercise by the mean 
ambient concentration. As with the Reference method, the harmonic mean of the 
four exercise fit factors represented the overall fit factor. A minimum fit 
factor of 100 is required in order to be regarded as an acceptable fit for 
half-mask respirators under appendix A of the Respiratory Protection Standard.

To ensure that respirator fit was not significantly altered between the two 
sets of exercises, a 5-second normal breathing fit factor assessment was 
included before the first exercise set, between the two sets of exercises 
and at the completion of the second exercise set. If the ratio of the 
maximum to minimum of these three fit factors was greater than 100, this 
experimental trial was excluded from data analysis.

2. STUDY RESULTS

The ANSI/AIHA standard specifies that an exclusion zone within one coefficient 
of variation for the Reference method must be determined. The exclusion zone 
is the range of measured fit factors around the pass/fail fit factor of 100 
which cannot be confirmed to be greater than 100 or less than 100 with 
adequate confidence and, therefore, should not be included in evaluating 
performance. TSI determined the variability associated with the Reference 
method using 48 pairs of fit factors from 16 participants. The exclusion zone 
was defined as fit factor measurements within one standard deviation of the 
100 pass/fail value. Six pairs of fit factors were omitted because the normal 
breathing fit factor ratio exceeded 100 and 5 pairs of fit factors were 
omitted because they were identified as outliers (>3 standard deviations 
from the mean of the remaining data points). The exclusion zone calculated 
by the study authors ranged from 82-123 and did not include the five outliers. 
During review of the study methods, OSHA felt that omitting outliers to define 
a variability-based exclusion zone deviated from the usual scientific practice. 
Therefore, OSHA recalculated the exclusion zone with the outlier data included 
in the analysis (Brosseau and Jones, 2015). The recalculated exclusion zone was 
somewhat wider, ranging from 68 to 146.

The final dataset for the ANSI/AIHA Fast-Half performance evaluation included 
134 pairs of fit factors from 25 participants. Equivalent fractions of each 
respirator and model were included. Eleven pairs were omitted because the 
ratio of maximum to minimum normal breathing fit factors was greater than 
100 and 1 pair was omitted due to a methodological error; 122 pairs were 
included in the data analysis.

According to the statistical procedures utilized in the study, the Fast-Half 
method, even utilizing the wider OSHA-recalculated exclusion zone, met the 
required acceptance criteria for test sensitivity, predictive value of a pass, 
predictive value of a fail, test specificity, and kappa statistic[1] as defined 
in ANSI/AIHA Z88.10-2010 (see Table 1). The study authors concluded that the 
results demonstrated that the new Fast-Half method can identify poorly fitting 
respirators as well as the reference method.

C. Evaluation of Fast-Full Method

1. STUDY METHODS

The peer-reviewed article entitled "Evaluation of a Faster Fit Testing Method 
for Full-Facepiece Respirators Based on the TSI PortaCount®," appeared 
in a 2013 issue (Volume 30, Number 2) of the Journal of the International 
Society for Respiratory Protection (Richardson et al., 2013). The study authors 
selected three models of NIOSH-approved, full-facepiece air-purifying 
respirators from "leading U.S. mask manufacturers" equipped with P100 
filters. Each model was available in three sizes. Respirators were probed 
with a non-flush sampling probe inside the nose cup, extending 0.6 into the 
breathing zone. Twenty-seven participants (11 female; 16 male) were included 
in the study; face sizes were predominantly in the central cells 
(2, 3, 4, 5, 7, 8 and 9) of the NIOSH bivariate panel; 1 subject had a face 
size in cell 6 and none were in cells 1 (very small) or 10 (very large). 
The Reference method, choice of exercises, PortaCount® instrument, 
test aerosol, and sampling sequence were exactly the same as those used 
for the Fast-Half method. A minimum fit factor of 500 is required in order 
to be regarded as an acceptable fit for full-facepiece respirators under 
appendix A of the Respiratory Protection Standard.

2. STUDY RESULTS

TSI determined the variability associated with the Reference method using 
54 pairs of fit factors from 17 participants. The exclusion zone was defined 
as fit factor measurements within one standard deviation of the 500 
pass/fail value. Five pairs of fit factors were omitted because the normal 
breathing fit factor ratio exceeded 100, and three pairs of fit factors 
were omitted because they were identified as outliers (>3 standard deviations 
from the mean of the remaining data points). The exclusion zone calculated 
by the study authors ranged from 345-726 and did not include the three 
outliers. OSHA recalculated the exclusion zone with the outlier data included 
in the analysis (Brosseau and Jones, 2015). The recalculated exclusion zone 
determined by OSHA was somewhat wider ranging from 321-780.

The final dataset for the ANSI/AIHA Fast-Full performance evaluation included 
148 pairs of fit factors from 27 participants. Equivalent fractions of each 
respirator and model were included. Eleven pairs were omitted because the 
ratio of maximum to minimum normal breathing fit factors was greater than 100; 
1 pair was omitted due to an observational anomaly; 136 pairs were included 
in the data analysis.

According to the statistical procedures utilized in the study, the Fast-Full 
method, even utilizing the wider OSHA-recalculated exclusion zone, met the 
required acceptance criteria for test sensitivity, predictive value of a 
pass, predictive value of a fail, test specificity, and kappa statistic as 
defined in ANSI/AIHA Z88.10-2010 (see Table 1). The authors concluded that 
the results demonstrated that the new Fast-Full method can identify poorly 
fitting respirators as well as the reference method.

D. Evaluation of Fast-FFR Method

1. STUDY METHODS

The peer-reviewed article, entitled "Evaluation of a Faster Fit Testing 
Method for Filtering Facepiece Respirators Based on the TSI PortaCount®," 
appeared in a 2014 issue (Volume 31, Number 1) of the Journal of the 
International Society for Respiratory Protection (Richardson et al., 2014b). 
Ten models of NIOSH-approved N95 FFRs from six "leading U.S. mask manufacturers" 
were selected for study. The different models were selected to Start Printed 
Page 69744represent a range of styles-6 cup-shaped, 2 horizontal flat-fold, 
and 2 vertical flat-fold models. No information was provided in the publication 
about whether models were available in different sizes. However, at the 
Agency's request, TSI submitted additional information regarding the choice 
of respirators via a letter (TSI, 2015b). The letter states:

The study plan for FFR called for 10 N95 FFR. Unlike elastomeric respirators, 
FFR designs vary widely and are typically not offered in different sizes. 
The authors felt it was important to use a variety of designs that represent 
the styles currently available in the US. Of the 10 models used, 6 were 
cup-shaped, 2 were vertical-fold, and 2 were horizontal-fold designs. 
The cup-shaped style is by far the most common, which is why 6 of the 10
model selected have that fundamental design. Four flat-fold designs 
(2 vertical-fold and 2 horizontal-fold) models are also included.

Respirators were probed with a flush sampling probe located between the 
nose and mouth. Lightweight sample tubing and neck straps were used to 
ensure the tubing did not interfere with respirator fit. Twenty-nine 
participants (11 female; 18 male) were included in the study; face sizes 
were predominantly in the smaller and central cells (1, 2, 3, 4, 5, 7, 8) 
of the NIOSH bivariate panel; 1 subject was in cell 6 and no subjects were 
in cells 9 or 10 (those with longer-nose to chin-face sizes). The Reference 
method, test aerosol, and most other study procedures were analogous to 
those used for the Fast-Half and Fast-Full methods. However, the Fast-FFR 
method employed these four exercises: Bending, talking, head side-to-side 
and head up-and-down with the same sampling sequence and durations as the 
other test protocols. The talking exercise replaces the jogging exercise used 
in the Fast-Half and Fast-Full methods. TSI decided not to eliminate the 
talking exercise for FFRs even though their pilot study indicated that it 
rarely produces the lowest fit factor (TSI, 2015a). They felt from their own 
experience that jogging does not represent the kind of motions that FFR 
wearers do when using the respirator (TSI, 2015a). TSI also indicated that 
the sampling probe configured on lightweight FFR respirators caused the 
respirator to pull down and away from the face during jogging creating 
unintentional leakage. A PortaCount® Model 8038 operated in the N95 
mode (TSI Inc., Shoreview MN), was used to measure aerosol concentrations 
throughout the experiments. The particle concentrations in the test chamber
 were expected to be greater than 400 p/cm3. A minimum fit factor of 100 is 
 required in order to be regarded as an acceptable fit for these types of 
 respirators under appendix A of the Respiratory Protection Standard.

2. STUDY RESULTS

The study administered sequential paired fit tests using the Fast-FFR 
method and a reference method according to the ANSI/AIHA standard. TSI 
determined the variability associated with the Reference method using 63 
pairs of fit factors from 14 participants. The exclusion zone was defined 
as fit factor measurements within one standard deviation of the 500 
pass/fail value. Two pairs of fit factors were omitted because the normal 
breathing fit factor ratio exceeded 100, and six pairs of fit factors 
were omitted because they were identified as outliers (>3 standard deviations 
from the mean of the remaining data points). The exclusion zone calculated 
by the study authors ranged from 78-128 and did not include the six outliers. 
OSHA recalculated the exclusion zone with the outlier data included in the 
analysis (Brosseau and Jones, 2015). The recalculated exclusion zone was 
somewhat wider ranging from 69-144.

The final dataset for the ANSI/AIHA Fast-FFR performance evaluation included 
114 pairs from 29 participants. Equivalent fractions of each respirator and 
model were included. Two pairs were omitted because the ratio of maximum to 
minimum normal breathing fit factors was greater than 100; 112 pairs were 
included in the data analysis.

According to the statistical procedures utilized in the study, the Fast-FFR 
method, even utilizing the wider OSHA-recalculated exclusion zone, met the 
required acceptance criteria for test sensitivity, predictive value of a 
pass, predictive value of a fail, test specificity, and kappa statistic as 
defined in ANSI/AIHA Z88.10-2010 (see Table 1). The authors concluded that 
the results demonstrated that the new Fast-FFR method can identify poorly 
fitting respirators as well as the reference method.

Table 1-Comparison of TSI Fit Test Protocols With ANSI Criteria

1The kappa values in the table are those determined 
using the OSHA recalculated exclusion zone. The kappa values reported 
by the journal authors using a narrower exclusion zone were 
0.90 and 0.87, respectively, for the Fast-Half and Fast-FFR methods. 
Other statistical values were the same for both OSHA and study 
author exclusion zone determinations.

E. Conclusions

OSHA believes that the information submitted by TSI in the July 10, 2014 
letter from Mr. Niccum in support of the modified PortaCount® 
quantitative fit test protocols meets the criteria for determining 
whether OSHA must publish fit-test protocols for notice-and-comment 
rulemaking established by the Agency in Part II of appendix A of its 
Respiratory Protection Standard. Therefore, the Agency is initiating 
this rulemaking to determine whether to approve these proposed protocols 
for inclusion in Part I.C of appendix A of its Respiratory Protection Standard.

Each proposed protocol is a variation of the standard OSHA-accepted 
PortaCount® protocol, but differs from it by the exercise sets, 
exercise duration, and sampling sequence. The major difference between 
the proposed Fast-Full and Fast-Half methods and the standard OSHA-accepted 
PortaCount® protocol is they include only 3 of the 7 current test 
exercises (i.e., bending, head side-to-side, and head up-and-down) plus 
a new exercise (i.e., jogging-in-place), and reduce the total test duration 
from 7.2 minutes to 2.5 minutes. The major difference between the proposed 
Fast-FFR method and the standard OSHA-accepted PortaCount® protocol is 
it includes 4 of the 7 current test exercises (i.e., bending, talking, head 
side-to-side, and head up-and-down), and it reduces the total test Start 
Printed Page 69745duration from 7.2 minutes to 2.5 minutes.

The Agency is proposing to add two modified PortaCount® protocols to 
appendix A (see section V of this preamble titled "Proposed Amendment to 
the Standard"). If approved, the new protocols would be alternatives to the
 existing quantitative fit-testing protocols already listed in the Part I.C 
 of appendix A of the Respiratory Protection Standard; employers would be 
 free to select these alternatives or to continue using any of the other 
 protocols currently listed in the appendix.

F. N95-Companion™ Technology

OSHA is also taking the opportunity of this rulemaking to make a clarifying 
change to appendix A of the Respiratory Protection Standard to reflect a 
technological development. The original PortaCount® model could only 
fit test elastomeric respirators (i.e., full-facepiece and half-mask) and 
filtering facepiece respirators equipped with ≥99% efficient filter media. 
In 1998, TSI introduced the N95-Companion™ Technology, which enables 
newer PortaCount® models to quantitatively fit test elastomeric 
respirators (i.e., full-facepiece and half-mask) and filtering facepiece 
respirators equipped with <99% efficient filter media (e.g., N95 filters). 
The N95-Companion™ Technology does not alter the fit-testing protocol; 
it merely enables the fit testing of respirators with <99% efficient filter 
media. Therefore, OSHA has proposed text to appendix A, Part I.C.3 to clarify 
the difference between the existing PortaCount® models with and without 
the N95-Companion™ Technology.

III. Issues for Public Comment

OSHA invites comments from the public regarding the accuracy and reliability 
of the proposed protocols, their effectiveness in detecting respirator 
leakage, and their usefulness in selecting respirators that will protect 
employees from airborne contaminants in the workplace. Specifically, the 
Agency invites public comment on the following issues:

• Were the three studies described in the peer-reviewed journal articles well 
controlled and conducted according to accepted experimental design practices 
and principles?

• Were the results of the three studies described in the peer-reviewed 
journal articles properly, fully, and fairly presented and interpreted?

• Did the three studies treat outliers appropriately in determination 
of the exclusion zone?

• Will the two proposed protocols generate reproducible fit-testing 
results?

• Will the two proposed protocols reliably identify respirators with 
unacceptable fit as effectively as the quantitative fit-testing protocols, 
including the OSHA-approved standard PortaCount® protocol, already 
listed in appendix A of the Respiratory Protection Standard?

• Did the protocols in the three studies meet the sensitivity, 
specificity, predictive value, and other criteria contained in the 
ANSI/AIHA Z88.10-2010, Annex A2, Criteria for Evaluating Fit Test 
Methods?

• Are the specific respirators selected in the three studies described 
in the peer-reviewed journal articles representative of the respirators 
used in the United States?

• Does the elimination of certain fit-test exercises (e.g., normal 
breathing, deep breathing, talking) required by the existing OSHA-approved 
standard PortaCount® protocol impact the acceptability of the proposed 
protocols?

• Is the test exercise, jogging-in-place, that has been added to 
the Fast-Full and Fast-Half protocols appropriately selected and adequately 
explained? Should the jogging exercise also be employed for the Fast-FFR 
protocol? Is the reasoning for not replacing the talking exercise with the 
more rigorous jogging exercise in the Fast-FFR protocol (as was done in 
Fast-Full and Fast-Half) adequately explained?

• Was it acceptable to omit the grimace from the Reference method 
employed in the studies evaluating performance of the proposed fit-testing 
protocols? Is it appropriate to exclude the grimace completely from the 
proposed protocols, given that it is not used in the calculation of the fit 
factor result specified under the existing or proposed test methods? If not, 
what other criteria could be used to assess its inclusion or exclusion?

• The protocols in the three studies specify that participants take 
two deep breaths at the extreme of the head side-to-side and head up-and-down 
exercises and at the bottom of the bend in the bend-forward exercise. 
According to the developers of these protocols, the deep breaths are included 
to make the exercises more rigorous and reproducible from one subject to the 
next. Are these additional breathing instructions adequately explained in the 
studies and in the proposed amendment to the standard? Are they reasonable 
and appropriate?

• Does OSHA's proposed regulatory text for the two new protocols offer 
clear instructions for implementing the protocols accurately?

IV. Procedural Determinations

A. Legal Authority

The purpose of the Occupational Safety and Health Act of 1970 
("the 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 
 achieve this goal, Congress authorized the Secretary of Labor to promulgate
  and enforce occupational safety and health standards (29 U.S.C. 655(b)).

Under the Act, a safety or health standard is a standard that "requires 
conditions, or the adoption or use of one or more practices, means, methods, 
operations, or processes, reasonably necessary or appropriate to provide 
safe or healthful employment or places of employment" (29 U.S.C. 652(8)). 
A standard is reasonably necessary or appropriate within the meaning of 
section 652(8) of the Act when it substantially reduces or eliminates a 
significant workplace risk, and is technologically and economically 
feasible, cost effective, consistent with prior Agency action or supported 
by a reasoned justification for departing from prior Agency action, and 
supported by substantial evidence; it also must effectuate the Act's 
purposes better than any national consensus standard it supersedes (see 
International Union, UAW v. OSHA (LOTO II), 37 F.3d 665 (D.C. Cir. 1994); 
and 58 FR 16612-16616 (March 30, 1993)). Rules promulgated by the Agency 
must be highly protective (see 58 FR 16612, 16614-15 (March 30, 1993); 
LOTO II, 37 F.3d 665, 669 (D.C. Cir. 1994)). Moreover, section 8(g)(2) 
of the Act authorizes OSHA "to prescribe such rules and regulations as 
[it] may deem necessary to carry out its responsibilities under the Act" 
(see 29 U.S.C. 657(g)(2)). OSHA adopted the respirator standard in 
accordance with these requirements (63 FR 1152).

Appendix A, part II of the respirator standard requires OSHA to commence
a rulemaking to adopt an alternative fit test protocol where an applicant 
provides a detailed description the protocol supported by a test report 
from an independent laboratory or a published study in a peer-reviewed 
industrial hygiene journal showing that the protocol is accurate and reliable. 
In such cases, OSHA relies on the authority in section 6(b)(7) of the OSH 
Act. This provision allows the Agency to make updates to technical monitoring, 
measuring, and medical examination requirements in a standard to reflect newly 
developed information using the informal rulemaking notice and comment procedures 
of section 553 of the Administrative Procedure Act, rather than the more 
elaborate procedures of section 6(b) of the Act. In this case, TSI's proposed
protocols are supported by three articles in a peer-reviewed industrial hygiene 
journal. Each article described one of the proposed protocols and explained how
test data support the protocol's accuracy and reliability. Section 6(b)(7) also
requires consultation with the Secretary of Health and Human Services, and here
OSHA has consulted informally with NIOSH about TSI's proposed protocols. 
OSHA anticipates that NIOSH will submit formal comments in response to 
this proposal.

Based on all the submitted information, and after consultation with NIOSH, 
OSHA has preliminarily determined that the modified PortaCount® protocols 
provide employees with protections comparable to protections afforded them by 
the standard PortaCount® protocol already approved by the Agency. OSHA has 
also made a preliminary finding that the proposed rule is technologically 
feasible because the protective measures it requires already exist.

As OSHA has explained before, Congress adopted section 6(b)(7) to provide a 
simple, expedited process to update technical requirements in Agency standards 
to ensure that they reflect current experience and technological developments 
(see 77 FR 17602). OSHA believes that the provision of an expedited process to
provide technical updates to existing standards shows Congress's intent that 
new findings of significant risk are unnecessary in such circumstances (see id.). 
But even if OSHA was proceeding under its normal standard setting requirements, 
it would need to make no new showing of significant risk because the new 
protocols would not replace existing fit-testing protocols, but instead would be 
alternatives to them. OSHA believes that the proposal would not directly increase 
or decrease the protection afforded to employees, nor would it increase employers' 
compliance burdens. As demonstrated in the following section, the proposal may 
reduce employers' compliance burdens by decreasing the time required to fit test 
respirators for employee use.

B. Preliminary Economic Analysis and Regulatory Flexibility Certification

The proposal is not economically significant within the context of 
Executive Order 12866 (58 FR 51735), or a "major rule" under Section 804 
of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 804). 
The proposal would impose no additional costs on any private- or public-sector 
entity, and does not meet any of the criteria for a significant or major rule 
specified by Executive Order 12866 or other relevant statutes. This rulemaking 
allows employers increased flexibility in choosing fit-testing methods for 
employees, and the final rule does not require an employer to update or replace 
its current fit-testing method(s) as a result of this rule if the fit-testing 
method(s) currently in use meets existing standards. Furthermore, as discussed, 
because the proposed rule offers additional options that employers would select 
only if those options imposed no net cost burden on them, the proposed rule 
would not have a significant economic impact on a substantial number of small 
entities.

The Agency is proposing to supplement the quantitative fit-testing (QNFT) 
protocols currently in appendix A of the Respiratory Protection Standard, 
including the standard PortaCount® protocol, with the proposed modified 
protocols. This would provide employers additional options to fit test their 
employees for respirator use. Employers already using the standard 
PortaCount® protocol would have a choice between the existing standard 
PortaCount® protocol, which consists of eight exercises lasting one minute 
each, or the proposed protocols, which OSHA estimates would save 4.8 minutes per 
fit test. This time saving would provide a corresponding cost saving to the 
employer.

According to TSI, the PortaCount® manufacturer, "[e]xisting owners of 
the PortaCount® Respirator Fit Tester Pro Model 8030 and/or PortaCount® 
Pro+ Model 8038 will be able to utilize the new protocols without additional 
expense. It will be necessary to obtain a firmware and FitPro software upgrade, 
which TSI will be providing as a free download. As an alternative to the free 
download, PortaCount® Models 8030 and 8038 returned for annual service will 
be upgraded without additional charge. Owners of the PortaCount® Plus Model 
8020 with or without the N95-Companion™ Technology (both discontinued in 
2008) will be limited to the current 8-exercise OSHA fit test protocol" (TSI, 
2015b). There are approximately 12,000 Model 8030 or 8038 units in the field, 
significantly more than the discontinued Model 8020. The time required to adopt 
the new proposed protocols is expected to be minimal for existing PortaCount® 
users. The users will be able to update the firmware and software, which is 
estimated to take less than 5 minutes, and the fit tester would be able to select 
the proposed protocol or the currently existing test in 29 CFR 1910.134. The 
updates can be installed at the establishment's location; they do not need to be 
sent into the manufacturer to load. For the individual being fit tested, it is also 
likely to take minimal time to gain an understanding of the new protocols. The 
existing respiratory protection rule contains an annual training component, and 
information about the new protocol could be imparted during that time, thus adding 
no additional burden to the employer or employee (TSI, 2015c). OSHA anticipates that 
the proposed protocols would be adopted by many employers who currently use the 
standard PortaCount® protocol for their employees. These employers would adopt 
the proposed protocols because they would take less time to administer than the 
standard PortaCount® protocol, thereby decreasing the labor cost required 
for fit testing their employees.

Other establishments use either some other form of quantitative fit testing or 
qualitative fit testing. The Agency expects that the proposed protocols are less 
likely to be adopted by employers who currently perform fit testing using other 
quantitative or qualitative fit tests because of the significant equipment and 
training investment they already will have made to administer these fit tests. 
For example, it is estimated that switching from qualitative to quantitative fit 
testing would require an upfront investment of between $8,000 and $12,000 
(TSI, 2015c).

While the Agency has estimates of the number of users of the PortaCount® 
technology at the establishment level, both from the manufacturer and from the 
2001 NIOSH Respirator Survey, what is not known is how many respirator wearers, 
that is, employees, are fit tested using a PortaCount® device. The Agency 
expects that economies of scale would apply in this situation-larger establishments 
would be more likely to encounter situations needing QNFT, but would also have 
more employees over which to spread the capital costs. Once employers have 
invested capital in a quantitative fit-testing device, they are likely to perform 
QNFT on a number of other devices and users, even if not all those devices require 
QNFT. If sufficiently large, some employers apparently choose to invest in a QNFT 
device, even though none of the respirator users may technically be required to 
use a QNFT. Also, some QNFT devices are acquired by third parties, or 
"fit-testing houses," that provide fit-testing services to employers. In short, 
employers using PortaCount® QNFT will not be average size establishments for 
the purpose of estimating the number of respirator wearers. Some of these 
establishments might use them for hundreds or possibly thousands of respirator 
wearers in the course of a year. Alternately, one could look at the number of 
respirator users estimated to be using respirators that would presumably 
require QNFT, although it is uncertain what percentage of the QNFT market 
utilizes the PortaCount® technology currently; also uncertain is the 
percentage of users of optional QNFT devices using QNFT currently.

Nonetheless, it is possible to develop a plausible estimate of the number of 
potentially affected respirator wearers, in which these two sets of data converge. 
For example, if one starts with an estimate of 12,000 establishments using PortaCount® 
models 8030 and 8038 annually for all of their employees and assumes an average of 100 
respirator wearers fit tested annually per establishment, this would yield an estimate 
of 1.2 million respirator wearers that could potentially benefit from the new QNFT 
protocol.[2] Alternately, a similar estimate can be obtained if one assumes that 50 
percent of the devices requiring QNFT (such as full-facepiece elastomeric negative 
pressure respirators) use PortaCount® currently, as well as 25 percent of half-mask 
elastomeric respirators, and 10 percent of filtering facepieces.[3] At a loaded wage 
rate of $33.81 and assuming savings of 5 minutes per respirator wearer per year, this
 would imply an annual savings for respirator wearers of approximately $3.4 million.[4] 
 There would also likely be some time savings for the person administering the fit tests. 
 The time saved may potentially be as much as a one-to-one ratio between the tester and 
 those being tested. The Agency solicits comment on the practical experience of 
 employers and others administering fit tests as to the likely effects on total labor 
 productivity (or potentially other cost elements) from being able to expedite the 
 fit-testing process. As discussed, this does not include potential conversions from 
 other types of fit-testing methods currently being used. Alternately, it is possible 
 that some of these assumptions could be overestimates or that some employers are 
 simply comfortable with the existing method and would continue to use the existing 
 protocol despite the potential time savings.

REGULATORY FLEXIBILITY CERTIFICATION

In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (as amended), 
OSHA has examined the regulatory requirements of the proposed rule to determine whether 
these proposed requirements would have a significant economic impact on a substantial 
number of small entities. This proposed rule would impose no required costs and could 
provide a cost savings in excess of $3 million per year to regulated entities. The 
Assistant Secretary for Occupational Safety and Health therefore certifies that the 
proposed rule, if adopted, would not have a significant economic impact on a substantial 
number of small entities.

C. Paperwork Reduction Act

The purposes of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., 
include enhancing the quality and utility of information the Federal government requires 
and minimizing the paperwork burden on affected entities. The PRA requires certain 
actions before an agency can adopt or revise a collection of information (paperwork), 
including publishing a summary of the collection of information and a brief description 
of the need for and proposed use of the information.

A Federal agency may not conduct or sponsor a collection of information unless it is 
approved by the Office of Management and Budget (OMB) under the PRA and displays a currently 
valid OMB control number; the public is not required to respond to a collection of 
information unless it displays a currently valid OMB control number. When a NPRM includes
an information collection, the sponsoring agency must submit a request to the OMB in order 
to obtain PRA approval. OSHA is submitting an Information Collection Request (ICR), 
concurrent with the publication of this NPRM. A copy of this ICR with applicable supporting 
documentation, including a description of the likely respondents, proposed frequency of 
response, and estimated total burden, may be obtained free of charge from the RegInfo.gov 
Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201511-1218-005 (this link 
will only become active on the day following publication of this notice) or by contacting 
Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of 
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.

The proposed protocols of this NPRM would revise the information collection in a way 
that reduces existing burden hours and costs. In particular, the paperwork requirement 
specified in paragraph (m)(2) of OSHA's Respiratory Protection Standard, at 29 CFR 1910.134, 
specifies that employers must document and maintain the following information on quantitative 
fit tests administered to employees: The name or identification of the employee tested; the 
type of fit test performed; the specific make, model, style, and size of respirator tested; 
the date of the test; and the test results. The employer must maintain this record until 
the next fit test is administered. While the information on the fit-test record remains the 
same, the time to obtain the necessary information for the fit-test record could be reduced 
since some of the proposed protocols would take an employer less time to administer that 
those currently approved in appendix A. OSHA accounts for this burden under the Information 
Collection Request, or paperwork analysis, for the Respiratory Protection Standard 
(OMB Control Number 1218-0099).

OSHA has estimated that the addition of a new protocol, which takes less time to administer, 
will result in a burden hour reduction of 150,432 hours. OSHA has submitted a revised 
Respiratory Protection ICR reflecting this reduction to OMB. As required by 5 
CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), OSHA is providing the following summary information 
about the Respiratory Protection information collection:

Title: Respiratory Protection Standard (29 CFR 1910.134).

Number of respondents: 616,035.

Frequency of responses: Various.

Number of responses: 23,443,707.

Average time per response: Various.

Estimated total burden hours: 6,971,401.

Estimated costs (capital-operation and maintenance): $296,098,562.

The Agency solicits comments on these determinations. In addition, the Agency is 
particularly interested in comments that:

• Evaluate whether the collections of information are necessary for the proper
performance of the Agency's functions, including whether the information is useful;

• Evaluate the accuracy of OSHA's estimate of the burden (time and cost) of the 
information collection requirements, including the validity of the methodology and 
assumptions used;

• Evaluate the quality, utility and clarity of the information collected; and

• Evaluate ways to minimize the compliance burden on employers, for example, 
by using automated or other technological techniques for collecting and transmitting information.

Members of the public who wish to comment on the Agency's collection of information 
may send their written comments to the Office of Information and Regulatory Affairs, 
Attn: Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 
Washington DC 20503. You may also submit comments to OMB by email at 
OIRA.submission@omb.gov (please reference control number 1218-0099 in order to help 
ensure proper consideration). The Agency encourages commenters also to submit their 
comments related to the Agency's clarification of the collection of information 
requirements to the rulemaking docket (Docket Number OSHA-2015-0006) along with their 
comments on other parts of the proposed rule. For instructions on submitting these 
comments to the rulemaking docket, see the sections of this Federal Register notice 
titled DATES and ADDRESSES. You also may obtain an electronic copy of the complete ICR 
by visiting the Web page at http://www.reginfo.gov/public/do/PRAMain and scrolling under 
"Currently Under Review" to "Department of Labor (DOL)" to view all of the DOL's ICRs, 
including those ICRs submitted for proposed rulemakings. To make inquiries, or to request 
other information, contact Todd Owen, Directorate of Standards and Guidance, OSHA, 
Room N-3609, U.S. Department of Labor, 200 Constitution Avenue NW., Washington DC 20210; 
telephone (202) 693-2222; email owen.todd@dol.gov.

D. Federalism

OSHA reviewed the proposal according to the Executive Order on Federalism (E.O. 13132, 
64 FR 43255, Aug. 10, 1999), which requires that Federal agencies, to the extent possible, 
refrain from limiting state policy options, consult with states before taking actions that 
would restrict states' policy options and take such actions only when clear constitutional 
authority exists and the problem is of national scope. The Executive Order provides for 
preemption of state law only with the expressed consent of Congress. Federal agencies must 
limit any such preemption to the extent possible.

Under section 18 of the Occupational Safety and Health Act (the "Act," 29 U.S.C. 651 et 
seq.), Congress expressly provides that states may adopt, with Federal approval, a plan 
for the development and enforcement of occupational safety and health standards 
(29 U.S.C. 667). OSHA refers to states that obtain Federal approval for such a plan as 
"State Plan states." Occupational safety and health standards developed by State Plan 
states must be at least as effective in providing safe and healthful employment and 
places of employment as the Federal standards. Subject to these requirements, State Plan 
states are free to develop and enforce under state law their own requirements for 
occupational safety and health standards.

With respect to states that do not have OSHA-approved plans, the Agency concludes 
that this proposed rule conforms to the preemption provisions of the Act. 
Section 18 of the Act prohibits states without approved plans from issuing citations 
for violations of OSHA standards. The Agency finds that the proposed rulemaking does 
not expand this limitation. Therefore, for States that do not have approved 
occupational safety and health plans, this proposed rule would not affect the 
preemption provisions of Section 18 of the Act.

OSHA's proposal for additional fit-testing protocols under its Respiratory Protection 
Standard at 29 CFR 1910.134 is consistent with Executive Order 13132 because the 
problems addressed by these fit-testing requirements are national in scope. The Agency 
preliminarily concludes that the fit-testing protocols proposed by this rulemaking would 
provide employers in every state with procedures that would assist them in protecting 
their employees from the risks of exposure to atmospheric hazards. In this regard, the 
proposal offers thousands of employers across the nation an opportunity to use additional 
protocols to assess respirator fit among their employees. Therefore, the proposal would 
provide employers in every state with an alternative means of complying with the fit-testing 
requirements specified by paragraph (f) of OSHA's Respiratory Protection Standard.

Should the Agency adopt a proposed standard in a final rulemaking, Section 18(c)(2) of the 
Act (29 U.S.C. 667(c)(2)) requires State Plan states to adopt the same standard, or to 
develop and enforce an alternative standard that is at least as effective as the OSHA 
standard. However, the new fit-testing protocols proposed in this rulemaking would only 
provide employers with alternatives to the existing fit-testing protocols specified in 
the Respiratory Protection Standard; therefore, the alternative is not, itself, a 
mandatory standard. Accordingly, states with OSHA-approved State Plans would not be 
obligated to adopt the final provisions that may result from this proposed rulemaking. 
Nevertheless, OSHA strongly encourages them to adopt the final provisions to provide 
additional compliance options to employers in their states.

In summary, this proposal complies with Executive Order 13132. In states without 
OSHA-approved State Plans, this proposed rule limits state policy options in the same 
manner as other OSHA standards. In State Plan states, this rulemaking does not 
significantly limit state policy options.

E. State-Plan States

Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-Plan states to adopt 
mandatory standards promulgated by OSHA. However, as noted in the previous section of this 
preamble, states with OSHA-approved State Plans would not be obligated to adopt the final 
provisions that may result from this proposed rulemaking. Nevertheless, OSHA strongly 
encourages them to adopt the final provisions to provide compliance options to employers 
in their States. In this regard, OSHA preliminarily concludes that the fit-testing protocols 
proposed by this rulemaking would provide employers in the State-Plan states with procedures 
that would protect the safety and health of employees who use respirators against hazardous 
airborne substances in their workplace at least as well as the existing quantitative 
fit-testing protocols in appendix A of the Respiratory Protection Standard.

There are 28 states and U.S. territories that have their own OSHA-approved occupational 
safety and health programs called State Plans. The following 22 State Plans cover state 
and local government employers and private-sector employers: Alaska, Arizona, California, 
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, 
Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, 
and Wyoming. The following six State Plans cover state and local government employers only: 
Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin Islands.

F. Unfunded Mandates Reform Act

OSHA reviewed this notice of proposed rulemaking according to the Unfunded Mandates 
Reform Act of 1995 (UMRA) 2 U.S.C. 1501-1507 and Executive Order 12875, 58 FR 58093 (1993). 
As discussed above in section B of this preamble ("Preliminary Economic Analysis and 
Regulatory Flexibility Certification"), OSHA preliminarily determined that the proposed rule 
imposes no additional costs on any private-sector or public-sector entity. The substantive 
content of the proposed rule applies only to employers whose employees use respirators for 
protection against airborne contaminants, and compliance with the protocols contained in the 
proposed rule would be strictly optional for these employers. Accordingly, the proposed rule 
would require no additional expenditures by either public or private employers. Therefore, 
this proposal is not a significant regulatory action within the meaning of Section 202 of 
the UMRA, 2 U.S.C. 1532.

As noted above under Section E ("State Plan States") of this preamble, OSHA standards do not 
apply to state or local governments except in states that have voluntarily elected to adopt 
an OSHA-approved State Plan. Consequently, this notice of proposed rulemaking does not meet 
the definition of a "Federal intergovernmental mandate" (see 2 U.S.C. 658(5)). Therefore, 
for the purposes of the UMRA, the Assistant Secretary for Occupational Safety and Health 
certifies that this proposal does not mandate that state, local, or tribal governments adopt 
new, unfunded regulatory obligations, or increase expenditures by the private sector of more 
than $100 million in any year.

G. Applicability of Existing Consensus Standards

Section 6(b)(8) of the Act (29 U.S.C. 655(b(8)) requires OSHA to explain "why a rule promulgated
by the Secretary differs substantially from an existing national consensus standard," by 
publishing "a statement of the reasons why the rule as adopted will better effectuate the 
purposes of the Act than the national consensus standard." In this regard, when OSHA promulgated 
its original respirator fit-testing protocols under appendix A of its final Respiratory 
Protection Standard (29 CFR 1910.134), no national consensus standards addressed these protocols. 
Later, the American National Standards Institute (ANSI) developed a national consensus 
standard on fit-testing protocols ("Respirator Fit Testing Methods," ANSI Z88.10-2001) as 
an adjunct to its national consensus standard on respiratory protection programs. ANSI/AIHA 
updated the Z88.10 standard in 2010 ("Respirator Fit Testing Methods," ANSI Z88.10-2010).

Paragraph 7.2 of ANSI/AIHA Z88.10-2010 specifies the requirements for conducting a 
particle-counting instrument (e.g., PortaCount®) quantitative fit test, which differ 
substantially from the standard PortaCount® protocol provided in appendix A of OSHA's 
Respiratory Protection Standard. These protocols differ in terms of both the fit-testing 
exercises required and the duration of these exercises. The proposed modified PortaCount® 
protocols are variations of the ANSI/AIHA particle-counting instrument quantitative fit test 
protocol, in that they require the same 30 second duration for fit-testing exercises, but 
they do not require the same exercises required by ANSI/AIHA. However, Annex A2 of ANSI/AIHA 
Z88.10-2010 recognizes that a universally accepted measurement standard for respirator fit 
testing does not exist and provides a specific procedure and criteria for evaluating new 
fit-testing methods. The Agency is requiring that in order to be adopted by the Agency, TSI 
statistically show that its proposed modified PortaCount® protocols meet the ANSI/AIHA 
Annex A2 performance requirements. The Agency believes that if the proposed modified 
PortaCount® protocols meet the criteria outlined in ANSI/AIHA Z88.10-2010, Annex A2, 
then they would be as accurate and reliable as the ANSI/AIHA protocol, but shorter in 
duration and less costly to administer.

H. Advisory Committee for Construction Safety and Health (ACCSH) Review of the Proposed Standard

The proposal to add two quantitative fit-test protocols to appendix A of OSHA's Respiratory
Protection Standard would affect the construction industry because it revises the fit-testing 
procedures specified by the standard, which is applicable to the construction industry 
(see 29 CFR 1926.103). Whenever the Agency proposes a rule involving construction activities, 
the Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3704), 
OSHA regulations governing the Advisory Committee for Construction Safety and Health (ACCSH) 
(i.e., 29 CFR 1912.3), and provisions governing OSHA rulemaking (i.e., 29 CFR 1911.10) require 
OSHA to consult with the ACCSH. Specifically, 29 CFR 1911.10 requires that the Assistant 
Secretary provide the ACCSH with "any proposal of his own," together with "all pertinent 
factual information available to him, including the results of research, demonstrations, 
and experiments." Accordingly, OSHA provided the ACCSH members with copies of Mr. Niccum's 
application letter and its supporting documents, along with other relevant information, prior 
to the December 4, 2014 ACCSH meeting. OSHA staff presented a slide presentation to the ACCSH 
at that meeting to explain the proposal. At the end of this session, the ACCSH unanimously 
recommended to proceed with the initiation of a notice-and comment rulemaking under 
Section 6(b)(7) of the OSH Act to seek public comment on adding proposed new fit-test 
protocols into appendix A of the Respiratory Protection Standard.

V. References

[ANSI/AIHA] American National Standards Institute, Inc./American Industrial Hygiene Association. 
(2010). ANSI/AIHA Z88.10-2010. American National Standard-Respirator Fit Testing Methods. 
American Industrial Hygiene Association, Fairfax, VA.
[BLS] Bureau of Labor Statistics. (2016a). News Release, March 30, 2016. 
Occupational Employment and Wages-May 2015. http://www.bls.gov/news.release/pdf/ocwage.pdf [See Table 1].
[BLS] Bureau of Labor Statistics. (2016b). News Release, March 10, 2016. 
Employer Costs for Employee Compensation, December 2015. 
http://www.bls.gov/news.release/archives/ecec_03102016.pdf [See Table A]
Brosseau, LM and Jones RM. (2015). Evaluation of three new condensation nuclei 
counter (CNC) fit testing protocols. February 22, 2015.
Census Bureau. (2012). County Business Patterns. File downloaded 6/3/2014 
http://www.census.gov/​econ/​cbp/​download/​ [See 2012 See "Complete U.S. File"]
[NIOSH] National Institute for Occupational Safety and Health. (2003). 
Respirator Usage in Private Sector Firms, 2001. Bureau of Labor Statistics, 
National Institute for Occupational Safety and Health, September 2003. http://www.cdc.gov/niosh/docs/respsurv/pdfs/respsurv2001.pdf
Richardson, AW, Hofacre, KC, Weed, J, Holm, R, and Remiarz, R. (2013). 
Evaluation of a faster fit testing method for full-facepiece respirators based 
on the TSI PortaCount®. Journal of the International Society for Respiratory Protection. 30(2): 116-128.
Richardson, AW, Hofacre, KC, Weed, J, Holm, R, and Remiarz, R. (2014a). Evaluation 
of a faster fit testing method for elastomeric half-mask respirators based on the 
TSI PortaCount®. Journal of the International Society for Respiratory Protection. 31(1): 9-22.
Richardson, AW, Hofacre, KC, Weed, J, Holm, R, and Remiarz, R. (2014b). Evaluation of a 
faster fit testing method for filtering facepiece respirators based on the TSI PortaCount®. 
Journal of the International Society for Respiratory Protection. 31(1): 43-56.
TSI. (2014a). Application letter submitted to OSHA by Darrick Niccum of TSI, July 10, 2014a.
TSI. (2014b). TSI White Paper: Analysis of the talking exercise used for respirator fit 
testing, July 10, 2014b.
TSI. (2015a). Exercise Rational Cover Letter and Exercise Selection Rationale White Paper 
submitted to OSHA by Gregory Olson of TSI, February 6, 2015.
TSI. (2015b). Letter submitted to OSHA by TSI (Gregory Olson), April 2, 2015.
TSI. (2015c). Phone conversation between TSI and Labor Department employees, April 6, 2015.
Zhuang, Z, Coffey, CC and Lawrence, RB. (2004). The effect of ambient aerosol concentration 
and exercise on PortaCount® quantitative fit factors. Journal of the International Society 
for Respiratory Protection 21: 11-20.

• List of Subjects in 29 CFR Part 1910
• Fit testing
• Hazardous substances
• Health
• Occupational safety and health
• Respirators
• Respiratory protection
• Toxic substances

Authority and Signature

David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety 
and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 
20210 directed the preparation of this notice. Accordingly, the Agency issues this 
notice under the following authorities: 29 U.S.C. 663, 655 and 656, 40 U.S.C. 3701, 
et seq., Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR part 1911.

Signed at Washington, DC, on September 26, 2016.

David Michaels,

Assistant Secretary of Labor for Occupational Safety and Health.

Proposed Amendment to the Standard

For the reasons stated in the preamble, the Agency proposes to amend 29 CFR part 1910 as follows:

PART 1910-OCCUPATIONAL SAFETY AND HEALTH STANDARDS
Subpart I-Personal Protective Equipment
1. Revise the authority citation for subpart I of part 1910 to read as follows:

Authority: 29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 
(41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 
5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as 
applicable, and 29 CFR part 1911.

2. Amend appendix A to §1910.134 as follows:

a. Revise the introductory text of paragraph 14(a) in Part I.A.

b. In Part I.C.3, revise the introductory paragraph and remove the terms "Portacount tm" and 
"Portacount" and add in their place the term "PortaCount®" wherever they occur.

c. In Part I.C, redesignate protocol 4, "Controlled negative pressure (CNP) quantitative fit 
testing protocol." as protocol 6.

d. In Part I.C, redesignate protocol 5, "Controlled negative pressure (CNP) REDON quantitative 
fit testing protocol." as protocol 7.

e. Add new protocols 4 and 5.

f. Revise paragraphs (a) and (b) in newly redesignated Part I.C.7.

The revisions and additions read as follows:

§1910.134 Respiratory protection.
* * * * *
Appendix A to §1910.134-Fit Testing Procedures (Mandatory)
Part I. OSHA-Accepted Fit Test Protocols

A. Fit Testing Procedures-General Requirements

* * * * *
14. * * *

(a) Employers must perform the following test exercises for all fit testing methods prescribed in 
this appendix, except for the two modified CNC quantitative fit testing protocols, the CNP 
quantitative fit testing protocol, and the CNP REDON quantitative fit testing protocol. For the 
modified CNC quantitative fit testing protocols, employers shall ensure that the test subjects 
(i.e., employees) perform the exercise procedure specified in Part I.C.4(b) of this appendix for 
full facepiece and half-mask elastomeric respirators, or the exercise procedure specified in 
Part I.C.5(b) of this appendix for filtering facepiece respirators. Employers shall ensure that 
the test subjects (i.e., employees) perform the exercise procedure specified in Part I.C.6(b) of 
this appendix for the CNP quantitative fit testing protocol, or the exercise procedure described 
in Part I.C.7(b) of this appendix for the CNP REDON quantitative fit testing protocol. For the 
remaining fit testing methods, employers shall ensure that the test exercises are performed in 
the appropriate test environment in the following manner:

* * * * *
C. Quantitative Fit Test (QNFT) Protocols

* * * * *
3. AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC) QUANTITATIVE FIT TESTING PROTOCOL

The ambient aerosol condensation nuclei counter (CNC) quantitative fit testing (PortaCount®) 
protocol quantitatively fit tests respirators with the use of a probe. The probed respirator is 
only used for quantitative fit tests. A probed respirator has a special sampling device, 
installed on the respirator, that allows the probe to sample the air from inside the mask. 
A probed respirator is required for each make, style, model, and size that the employer uses 
and can be obtained from the respirator manufacturer or distributor. The CNC instrument 
manufacturer, TSI Incorporated, also provides probe attachments (TSI mask sampling adapters) 
that permit fit testing in an employee's own respirator. A minimum fit factor pass level of at 
least 100 is necessary for a half-mask respirator (elastomeric or filtering facepiece), and a 
minimum fit factor pass level of at least 500 is required for a full facepiece elastomeric 
respirator. Two PortaCount® Respirator Fit Tester models are available. One model is used 
to fit test elastomeric respirators (i.e., full facepiece and half-mask) and filtering facepiece 
respirators using ≥99% efficient filter media, and another model, with the N95-Companion™ 
Technology capability, is used to fit test elastomeric respirators (i.e., full facepiece and half-mask) 
and filtering facepiece respirators with any type of filter media, including those equipped with 
<99% efficient filter media. The entire screening and testing procedure shall be explained to 
the test subject prior to the conduct of the screening test.

* * * * *
4. MODIFIED AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC) QUANTITATIVE FIT TESTING PROTOCOL FOR 
FULL FACEPIECE AND HALF-MASK ELASTOMERIC RESPIRATORS

(a) When administering this protocol to test subjects, employers shall comply with the requirements 
specified in Part I.C.3 of this appendix (ambient aerosol condensation nuclei counter (CNC) quantitative 
fit testing protocol), except they shall use the test exercises described below in paragraph (b) of this 
protocol instead of the test exercises specified in section I.C.3(a)(6) of this appendix.

(b) Employers shall ensure that each test subject being fit tested using this protocol follows the 
exercise and duration procedures, including the order of administration, described below in 
Table A-1 of this appendix.

Table A-1-Modified CNC Quantitative Fit Testing Protocol for Full Facepiece and Half-Mask 
Elastomeric Respirators

1Exercises are listed in the order in which they are to be administered.
2It is optional for test subjects to take additional breaths at other times during this exercise.

5. MODIFIED AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC) QUANTITATIVE FIT TESTING PROTOCOL 
FOR FILTERING FACEPIECE RESPIRATORS

(a) When administering this protocol to test subjects, employers shall comply with the requirements 
specified in Part I.C.3 of this appendix (Ambient aerosol condensation nuclei counter (CNC) quantitative 
fit testing protocol), except they shall use the test exercises described below in paragraph (b) of 
this protocol instead of the test exercises specified in section I.C.3(a)(6) of this appendix.

(b) Employers shall ensure that each test subject being fit tested using this protocol follows the 
exercise and duration procedures, including the order of administration, described below in 
Table A-2 of this appendix.

Table A-2-Modified CNC Quantitative Fit Testing Protocol for Filtering Facepiece Respirators

1Exercises are listed in the order in which they are to be administered.
2It is optional for test subjects to take additional breaths at other times during this exercise.

* * * * *

7. CONTROLLED NEGATIVE PRESSURE (CNP) REDON QUANTITATIVE FIT TESTING PROTOCOL

(a) When administering this protocol to test subjects, employers must comply with the requirements 
specified in paragraphs (a) and (c) of part I.C.6 of this appendix ("Controlled negative pressure 
(CNP) quantitative fit testing protocol,") as well as use the test exercises described below in 
paragraph (b) of this protocol instead of the test exercises specified in paragraph (b) of 
part I.C.6 of this appendix.

(b) Employers must ensure that each test subject being fit tested using this protocol follows the 
exercise and measurement procedures, including the order of administration described below in 
Table A-3 of this appendix.

Table A-3-CNP REDON Quantitative Fit Testing Protocol

1Exercises are listed in the order in which they are to be administered.

* * * * *

Footnotes

1. The kappa statistic is a measure of agreement between the proposed and reference fit-test methods. 
It compares the observed proportion of fit tests that are concordant with the proportion expected 
if the two tests were statistically independent. Kappa values can vary from -1 to +1. Values close 
to +1 indicate good agreement. ANSI/AIHA recommends kappa values >0.70.
2. TSI estimated the number of users of their devices at over 12,000 establishments (TSI, 2015c). 
This is consistent with data from the 2001 NIOSH respirator survey (NIOSH, 2003), which, if benchmarked 
to a 2012 count of establishments (Census Bureau, 2012) and containing fit-testing methods to include 
ambient aerosol, generated aerosol, and a proportionally allocated percentage of the "don't know" 
respondents, would provide an estimate of 12,458 establishments using PortaCount® currently. 
Based on information from TSI, the large majority of these are estimated to be the newer 8030 and 
8038 devices.
3. NIOSH respirator survey (NIOSH, 2003), benchmarked to 2012 County Business Patterns 
(Census Bureau, 2012). These estimates are based only on private employers. Governmental 
entities would account for an even larger number of respirator users.
4. Mean wage rate of $23.23 (BLS, 2016a), assuming fringe benefits are 31.3 percent of total 
compensation (BLS, 2016b).
[FR Doc. 2016-23928 Filed 10-6-16; 8:45 am]

BILLING CODE 4510-26-P