Additional PortaCount® Quantitative Fit-Testing Protocols: Amendment to Respiratory Protection Standard, 69740-69751 [2016-23928]

Agencies

• DEPARTMENT OF LABOR
• Occupational Safety and Health Administration

[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Proposed Rules]
[Pages 69740-69751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23928]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2015-0015]
RIN 1218-AC94


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

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

ACTION: Notice of proposed rulemaking; request for comments.

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SUMMARY: OSHA is proposing to add two modified PortaCount[supreg] 
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[supreg] protocol, but differ from it by the exercise sets, 
exercise duration, and sampling sequence. If approved, the modified 
PortaCount[supreg] 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[supreg] fit test devices 
equipped with the N95-CompanionTM Technology are covered by 
the approved PortaCount[supreg] 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 https://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 
https://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 https://www.regulations.gov or to the OSHA Docket Office at the 
address above. All comments and submissions are listed in the https://

[[Page 69741]]

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 https://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 https://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[supreg] 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[supreg] protocol in paragraphs (a) and (b) of Part I.C.3 of 
appendix A of the Respiratory Protection Standard, except:
     Revised PortaCount[supreg] QNFT protocol 1 reduced the 
duration of the eight fit-testing exercises from 60 seconds to 30 
seconds; and
     Revised PortaCount[supreg] 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[supreg] protocol. The standard 
PortaCount[supreg] protocol and instrumentation was introduced by TSI 
in 1987, and the use of the standard PortaCount[supreg] 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[supreg] quantitative fit test protocols to add to appendix A 
(TSI, 2014a). These three additional protocols are modified versions of 
the standard PortaCount[supreg] 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[supreg] 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[supreg] protocol for both 
full-facepiece and half-mask elastomeric respirators and a modified 
PortaCount[supreg] protocol for filtering-facepiece respirators.
    All three of TSI's modified PortaCount[supreg] protocols use the 
same fit-testing requirements and instrumentation specified for the 
standard PortaCount[supreg] protocol in paragraphs (a) and (b) of Part 
I.C.3 of

[[Page 69742]]

appendix A of the Respiratory Protection Standard, except that they 
differ from the standard PortaCount[supreg] 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[supreg] 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[supreg] 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[supreg],'' 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[supreg] 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 <=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[supreg] 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/cm\3\ (target = 10,000 p/cm\3\).
    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

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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.
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    \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.
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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[supreg],'' 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[supreg] 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[supreg],'' 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

[[Page 69744]]

represent 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[supreg] 
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/cm\3\. 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
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                                                    ANSI Z88.10      Fast-full       Fast-half       Fast-FFR
----------------------------------------------------------------------------------------------------------------
Sensitivity.....................................     [gteqt]0.95            0.98            0.96            1.00
PV Pass.........................................     [gteqt]0.95            0.98            0.97            1.00
Specificity.....................................     [gteqt]0.50            0.98            0.97            0.85
PV Fail.........................................     [gteqt]0.50            0.98            0.93            0.93
Kappa...........................................     [gteqt]0.70            0.97        \1\ 0.89        \1\ 0.89
----------------------------------------------------------------------------------------------------------------
\1\ The 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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

[[Page 69745]]

duration from 7.2 minutes to 2.5 minutes.
    The Agency is proposing to add two modified PortaCount[supreg] 
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-CompanionTM 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[supreg] 
model could only fit test elastomeric respirators (i.e., full-facepiece 
and half-mask) and filtering facepiece respirators equipped with 
[gteqt]99% efficient filter media. In 1998, TSI introduced the N95-
CompanionTM Technology, which enables newer 
PortaCount[supreg] 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-CompanionTM 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[supreg] models with and without the 
N95-CompanionTM 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[supreg] 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[supreg] 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

[[Page 69746]]

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[supreg] protocols provide employees with protections 
comparable to protections afforded them by the standard 
PortaCount[supreg] 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[supreg] 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[supreg] protocol would have a 
choice between the existing standard PortaCount[supreg] 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[supreg] manufacturer, ``[e]xisting 
owners of the PortaCount[supreg] Respirator Fit Tester Pro Model 8030 
and/or PortaCount[supreg] 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[supreg] Models 8030 and 8038 returned for annual service 
will be upgraded without additional charge. Owners of the 
PortaCount[supreg] Plus Model 8020 with or without the N95-
CompanionTM 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[supreg] 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[supreg] protocol for their employees. These 
employers would adopt the proposed protocols because they would take 
less time to administer than the standard PortaCount[supreg] 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[supreg] 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[supreg] 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[supreg]

[[Page 69747]]

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[supreg] 
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[supreg] 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[supreg] 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.
---------------------------------------------------------------------------

    \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[supreg] 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).
---------------------------------------------------------------------------

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 
https://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

[[Page 69748]]

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 https://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.

[[Page 69749]]

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[supreg]) quantitative fit test, which differ substantially 
from the standard PortaCount[supreg] 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[supreg] 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[supreg] protocols meet the 
ANSI/AIHA Annex A2 performance requirements. The Agency believes that 
if the proposed modified PortaCount[supreg] 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. https://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. 
https://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 https://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. https://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[supreg]. 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[supreg]. 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

[[Page 69750]]

filtering facepiece respirators based on the TSI PortaCount[supreg]. 
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[supreg] 
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

0
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.


0
2. Amend appendix A to Sec.  1910.134 as follows:
0
a. Revise the introductory text of paragraph 14(a) in Part I.A.
0
b. In Part I.C.3, revise the introductory paragraph and remove the 
terms ``PortacountTM'' and ``Portacount'' and add in their 
place the term ``PortaCount[supreg]'' wherever they occur.
0
c. In Part I.C, redesignate protocol 4, ``Controlled negative pressure 
(CNP) quantitative fit testing protocol.'' as protocol 6.
0
d. In Part I.C, redesignate protocol 5, ``Controlled negative pressure 
(CNP) REDON quantitative fit testing protocol.'' as protocol 7.
0
e. Add new protocols 4 and 5.
0
f. Revise paragraphs (a) and (b) in newly redesignated Part I.C.7.
    The revisions and additions read as follows:


Sec.  1910.134  Respiratory protection.

* * * * *

Appendix A to Sec.  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[supreg]) 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[supreg] 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-
CompanionTM 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.

[[Page 69751]]



   Table A-1--Modified CNC Quantitative Fit Testing Protocol for Full
             Facepiece and Half-Mask Elastomeric Respirators
------------------------------------------------------------------------
                                                           Measurement
         Exercises \1\            Exercise procedure        procedure
------------------------------------------------------------------------
Bending Over..................  The test subject shall  A 20 second
                                 bend at the waist, as   ambient sample,
                                 if going to touch his/  followed by a
                                 her toes for 50         30 second mask
                                 seconds and inhale 2    sample.
                                 times at the bottom
                                 \2\.
Jogging-in Place..............  The test subject shall  A 30 second mask
                                 jog in place            sample.
                                 comfortably for 30
                                 seconds.
Head Side-to-Side.............  The test subject shall  A 30 second mask
                                 stand in place,         sample.
                                 slowly turning his/
                                 her head from side to
                                 side for 30 seconds
                                 and inhale 2 times at
                                 each extreme \2\.
Head Up-and-Down..............  The test subject shall  A 30 second mask
                                 stand in place,         sample followed
                                 slowly moving his/her   by a 9 second
                                 head up and down for    ambient sample.
                                 39 seconds and inhale
                                 2 times at each
                                 extreme \2\.
------------------------------------------------------------------------
\1\ Exercises are listed in the order in which they are to be
  administered.
\2\ It 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
------------------------------------------------------------------------
                                                           Measurement
         Exercises \1\            Exercise procedure        procedure
------------------------------------------------------------------------
Bending Over..................  The test subject shall  A 20 second
                                 bend at the waist, as   ambient sample,
                                 if going to touch his/  followed by a
                                 her toes for 50         30 second mask
                                 seconds and inhale 2    sample.
                                 times at the
                                 bottom.\2\
Talking.......................  The test subject shall  A 30 second mask
                                 talk out loud slowly    sample.
                                 and loud enough so as
                                 to be heard clearly
                                 by the test conductor
                                 for 30 seconds. He/
                                 she will either read
                                 from a prepared text
                                 such as the Rainbow
                                 Passage, count
                                 backward from 100, or
                                 recite a memorized
                                 poem or song.
Head Side-to-Side.............  The test subject shall  A 30 second mask
                                 stand in place,         sample.
                                 slowly turning his/
                                 her head from side to
                                 side for 30 seconds
                                 and inhale 2 times at
                                 each extreme.\2\
Head Up-and-Down..............  The test subject shall  A 30 second mask
                                 stand in place,         sample followed
                                 slowly moving his/her   by a 9 second
                                 head up and down for    ambient sample.
                                 39 seconds and inhale
                                 2 times at each
                                 extreme.\2\
------------------------------------------------------------------------
\1\ Exercises are listed in the order in which they are to be
  administered.
\2\ It 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
------------------------------------------------------------------------
                                                           Measurement
         Exercises \1\            Exercise procedure        procedure
------------------------------------------------------------------------
Facing Forward................  Stand and breathe       Face forward,
                                 normally, without       while holding
                                 talking, for 30         breath for 10
                                 seconds.                seconds.
Bending Over..................  Bend at the waist, as   Face parallel to
                                 if going to touch his   the floor,
                                 or her toes, for 30     while holding
                                 seconds.                breath for 10
                                                         seconds.
Head Shaking..................  For about three         Face forward,
                                 seconds, shake head     while holding
                                 back and forth          breath for 10
                                 vigorously several      seconds.
                                 times while shouting.
REDON 1.......................  Remove the respirator   Face forward,
                                 mask, loosen all        while holding
                                 facepiece straps, and   breath for 10
                                 then redon the          seconds.
                                 respirator mask.
REDON 2.......................  Remove the respirator   Face forward,
                                 mask, loosen all        while holding
                                 facepiece straps, and   breath for 10
                                 then redon the          seconds.
                                 respirator mask again.
------------------------------------------------------------------------
\1\ Exercises are listed in the order in which they are to be
  administered.

* * * * *
[FR Doc. 2016-23928 Filed 10-6-16; 8:45 am]
 BILLING CODE 4510-26-P