[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Proposed Rules]
[Pages 54432-54434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket No. CDC-2013-0017; NIOSH-250]


Development of Inward Leakage Standards for Half-Mask Air-
Purifying Particulate Respirators

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Request for comment and notice of public meeting.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces a public meeting concerning inward leakage performance 
requirements for the class of NIOSH-certified non-powered air-purifying 
particulate respirators approved as half-facepiece respirators for 
protection from particulate-only hazards. The purpose of this meeting 
is to share information and to seek stakeholder feedback, in identified 
topic areas, concerning the development of inward leakage performance 
standards. Questions concerning the identified topics of specific 
interest are included in this document. Attendance at the public 
meeting is not required to submit written responses to the questions in 
this notice.

DATES: The public meeting will be held September 17, 2013, 1:00 p.m.-
5:00 p.m. ET, or after the last public commenter has spoken. 
Stakeholder comments to the questions included in this document must be 
received by 11:59 p.m. ET on October 18, 2013.

ADDRESSES: Meeting location: Bruceton Research Center, NIOSH National 
Personal Protective Technology Laboratory (NPPTL), 626 Cochrans Mill 
Road, Building 140, Multi-purpose Room, Pittsburgh, PA 15236. This 
meeting will also be available by remote access.
    Written Comments: You may submit comments by either of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2013-0017; NIOSH-250). All relevant comments, including any 
personal information provided, will be posted without change to http://www.regulations.gov.
    Docket: For access to the docket to read background documents and 
submitted comments, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Colleen Miller, NIOSH National 
Personal Protective Technology Laboratory (NPPTL), 626 Cochrans Mill 
Road, Pittsburgh, PA 15236 (412) 386-4956 or (412) 386-5200 (these are 
not toll free numbers).

SUPPLEMENTARY INFORMATION: 

I. Background

    Testing, quality control, and other requirements under 42 CFR Part 
84 are intended to ensure that respirators supplied to U.S. workers 
provide effective protection when properly employed within a complete 
respiratory protection program, as specified under MSHA and OSHA 
regulations. NIOSH requirements governing approval of half-mask air-
purifying particulate respirators, those defined in this notice, are 
principally specified in Part 84, under Subpart K--Non-Powered Air-
Purifying Particulate Respirators. The performance of the respirator's 
facepiece-to-face seal and other potential sources of inward leakage 
for this type of respirator are important to determine how much 
unfiltered contaminated air the worker might inhale. The facepiece-to-
face seal leakage can be substantial in the case of a poorly fitting 
respirator. Effective fit testing technology and procedures exist to 
ensure that half-mask respirators approved by NIOSH under Subpart K of 
Part 84 have adequately performing facepiece-to-face seals. The purpose 
of this notice is to solicit stakeholder feedback regarding standards 
for inward leakage testing.
    NIOSH believes that the employee is more likely to achieve a good 
fit from a respirator design that has been demonstrated to achieve a 
specified minimum level of performance during certification testing. 
Accordingly, NIOSH initiated rulemaking activities to establish inward 
leakage performance requirements for NIOSH-approved particulate 
filtering respirators by publishing a notice of proposed rulemaking 
(NPRM) in the Federal Register on October 30, 2009 [74 FR 56141]. The 
public comment period for the rulemaking closed originally on December 
28, 2009 but was subsequently extended upon request by stakeholders to 
September 30, 2010. Public meetings were held on December 3, 2009 and 
July 29, 2010 to allow stakeholders to share feedback on the proposed 
rule, including preliminary results of their independently completed or 
ongoing research. NIOSH reviewed all comments submitted by stakeholders 
and is considering them in the development of a revised inward leakage 
standard.

II. Test Panel History

    Although NIOSH requires adequate facepiece-to-face seals for other 
types of respirators under Part 84, such requirements have not been 
applied to

[[Page 54433]]

the half-mask air-purifying particulate respirators approved under 
subpart K. A new test panel, based on the bivariate distribution of 
face width and face length, was developed by NIOSH in 2007, based on 
research completed in 2003.\1\ The bivariate panel was developed 
following an anthropometric survey of 3,997 respirator users to better 
represent the U.S. civilian workforce by weighting subjects to match 
the age and race distribution of the U.S. population as determined from 
the 2000 census. In the rulemaking published in October 2009, NIOSH 
proposed to incorporate the bivariate panel into the standard testing 
procedures for inward leakage testing of these respirators.\2\
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    \1\ Zhuang Z, Bradtmiller B, and Shaffer R.E. New Respirator Fit 
Test Panels Representing the Current U.S. Civilian Workforce. 
Journal of Occupational and Environmental Hygiene 2007;4:647-659.
    \2\ NIOSH. Total Inward Leakage Test for Half-mask Air-purifying 
Particulate Respirators. Procedure No. RCT-APR-STP-0068. Available 
at http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-137/0137-081209-DraftTIL.pdf.
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    In response to stakeholder comments, specifically those addressing 
concerns about the potential for inter-panel variability when comparing 
panels comprising different test subjects, NIOSH researchers developed 
a peer-reviewed protocol to investigate the inter-panel variability. 
The study began in July 2012 and was recently completed. Data analysis 
is ongoing and public webinars to share preliminary results were held 
on July 23, 2013 and August 20, 2013.\3\
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    \3\ Presentation slides for both webinars are found in the 
dockets for this action.
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    During the inter-panel variability study, potential issues with the 
implementation of the proposed performance requirement were carefully 
considered by NIOSH leadership, researchers, standard and policy 
developers, and the technical experts responsible for NIOSH 
certification testing. This Federal Register notice includes questions 
for stakeholders to better understand and resolve potential 
implementation issues.

III. Public Meeting

    NIOSH will hold a public meeting on September 17, 2013 to discuss 
the development of inward leakage performance standards for the class 
of NIOSH-certified, non-powered half-facepiece respirators approved 
under the provisions of Subpart K of 42 CFR Part 84. The format of the 
meeting will be informal to encourage stakeholders to share information 
and responses regarding the information presented by NIOSH, the 
questions included in this notice, and any questions that may be 
identified during the meeting.
    This meeting will also be using Audio/LiveMeeting Conferencing 
remote access capabilities so that interested parties may listen in and 
view the presentations simultaneously over the Internet. Parties 
remotely accessing the meeting will have the opportunity to comment 
during the open comment period.
    Registration is required for both in-person and video conferencing 
participation. Because this meeting is being held at a Federal site, 
preregistration is required on or before September 10, 2013 and a 
government-issued photo ID will be required to obtain entrance to the 
facility. Non[hyphen]U.S. citizens must register on or before August 
30, 2013 to allow sufficient time for mandatory facility security 
clearance procedures to be completed. Non-U.S. citizens registered for 
another meeting at the site on September 17, 2013, will be considered 
to be registered for this meeting. NIOSH encourages all others to 
attend remotely.
    An email confirming registration will be sent from NIOSH for both 
in-person participation and video conferencing participation. 
Information regarding participation via the video conferencing will be 
provided in a separate email. This option will be available to 
participants on a first come, first served basis.
    Registration information is available on the NIOSH NPPTL Web site 
at http://www.cdc.gov/niosh/npptl/resources/pressrel/letters/lttr-09172013.html.

IV. Questions for Stakeholders

A. Inward Leakage Performance Standard Test Method

    1. Which of the following test method(s) would you recommend 
including in the standard test procedure for an inward leakage 
performance standard test method: Condensation nuclei counter (CNC) 
with differential mobility analyzer with supplemental aerosol, as 
needed; or general aerosol in a chamber with a quantitative detection 
method? Please provide your rationale and information that supports 
your recommendation including experiences, data, analyses, studies, 
published articles, and standard professional practices.
    2. In light of published data indicating that particle penetration 
through the filter media is negligible, in your opinion, if the CNC 
method is used:
    (a) Is the differential analyzer needed? Explain why or why not, 
providing your rationale and any supporting data or information, 
including references or sources of technical expert opinion.
    (b) What other detection method for ambient aerosol could be used? 
Provide any supporting documents, references, or data.
    (c) Is corn oil an acceptable method for evaluating N-series 
respirators (those restricted to use in workplaces free of oil 
aerosols) for certification purposes? Why or why not? Are there issues 
associated with corn oil degradation of the media during the time 
required to complete a typical OSHA fit test protocol? Please explain 
your answer. Would your concerns regarding the effects of corn oil be 
eliminated if the number of exposures to corn oil (i.e., repeated 
donnings) is limited? Please explain your answer.
    (d) What additional information or issues should NIOSH consider 
regarding the use of corn oil as an aerosol challenge during 
performance testing for filtering facepiece respirators? Please include 
specific information that supports your recommendation including 
experiences, data, analyses, studies, published articles, and standard 
professional practices.
    3. Should NIOSH allow the option of multiple inward leakage test 
methods?
    4. Should NIOSH define and establish inward leakage standards for 
quarter-masks? If you represent a respirator manufacturer, do you 
currently market quarter-mask respirators? If you are a purchaser, do 
you currently use quarter-mask respirators? Please include a 
description of the occupational use of the quarter-mask respirators you 
are manufacturing or using.

B. Subject Test Panels

    1. What are the advantages and/or disadvantages of using the NIOSH 
bivariate panel in assessing the facepiece-to-face seal as a regulatory 
requirement for respirators?
    (a) What are key implementation issues you foresee and how do you 
recommend addressing these issues?
    (b) Would you support the use of another panel, if so, which one 
(e.g., Los Alamos National Laboratory (LANL) full-facepiece panel, LANL 
half-facepiece panel \4\)? Please explain your answer.
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    \4\ Use of the LANL panels is established in Procedure No. TEB-
APR-STP-0005-05a-06, Determination of Qualitative Isoamyl Acetate 
(IAA) Facepiece Fit, Air-Purifying Respirators. Available at http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0005-05a-06.pdf.
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    2. Which panel(s) is your company currently using to develop new 
respirator models or to modify existing respirators? Please identify or 
define the panel (e.g., LANL full-facepiece, LANL half-facepiece, NIOSH 
bivariate, or Principal Component Analysis (PCA)),

[[Page 54434]]

the number of test subjects generally used, the distribution of the 
subjects within the panel cells, the sizing basis, and the 
representation of male and female test subjects. What pass/fail 
criteria are you currently using to approve proto-types for further 
development or production?
    (a) As a manufacturer, do you use facepiece-to-face seal criteria 
to qualify a design for production? Please include details about the 
criteria in your answer.
    (b) As a purchaser, what are the attributes you use to determine 
which brand(s) or model(s) of respirators to buy (e.g., price point, 
size, supplier, availability)?
    3. Does your company use a panel or portion of a panel to develop 
respirators for a defined user group (e.g., users with smaller facial 
features, users with larger facial features)? If so, please define the 
user group, the panel used, the cells included, and the number of 
subjects generally needed.
    (a) Could the LANL half-facepiece panel be used to test respirators 
for defined user groups? Please explain why or why not and include 
related implementation issues.
    (b) What issues do you foresee in the implementation of fit testing 
standards for defined user groups?
    4. Does your company use a panel or a portion of a panel to ensure 
the quality of a manufactured product line? If so, what test method and 
panel are used? How many subjects are included? Please explain how you 
maintain your pool of subjects.
    5. NIOSH currently uses the LANL half-facepiece panel (lip length, 
which is actually the lip width, and face length) for categorizing 
human subjects to evaluate those half-mask respirators evaluated for 
fit. What are the advantages and/or disadvantages of using the LANL 
half-facepiece panel for an inward leakage requirement for half-mask 
air-purifying particulate respirators, approved under subpart K, which 
are currently not evaluated for fit?
    6. What panel size would be sufficient for conducting a facepiece-
to-face seal certification test?
    (a) Given the recommended number of test subjects, should the pass/
fail criteria be specific and include a minimum of one pass per member 
cell? More than one per cell?
    (b) Given the recommended number of test subjects, should the pass/
fail criteria be panel based (e.g., 20/25, 28/35) and not specific to 
panel cells?
    (c) Should the pass/fail criteria require an overall high pass rate 
and allow for a percentage of failures or a lower fit factor pass 
criteria and a 100 percent pass rate?

C. Future Utility of the NIOSH Bivariate Panel for All NIOSH-Approved 
Respirators

    1. Based on your experience with the NIOSH bivariate panel, what 
implementation issues must NIOSH consider in order to use the NIOSH 
bivariate panel for certification testing of all classes of 
respirators?
    2. Should NIOSH develop a second NIOSH bivariate panel based on 
face length and lip length? Please explain why or why not and any 
implementation concerns or specific recommendations concerning future 
implementation of a new panel utilizing subject lip length and face 
length.

D. Inter-Panel Variability

    1. What is an appropriate pass/fail criterion? Assuming the CNC is 
used, should the subject pass with a fit factor of 20? 50? 75? 100?
    2. If a corn oil chamber is used, what inward leakage pass/fail 
criteria should be used?
    3. What other strategies do you suggest to address the inter-panel 
variability? Please provide specific information that supports your 
recommendation including experiences, data, analyses, studies, 
published articles, and standard professional practices.

    Dated: August 27, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-21430 Filed 9-3-13; 8:45 am]
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