Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators, 54432-54434 [2013-21430]

Download as PDF 54432 Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Proposed Rules Item name Testing frequency, allowable leakage rates, and other requirements (ii) USVs .................................................. Tested quarterly, not to exceed 120 days. If the device does not function properly, or if a liquid leakage rate > 400 cubic centimeters per minute or a gas leakage rate > 15 cubic feet per minute is observed, the valve must be removed, repaired and reinstalled, or replaced. (iii) BSDVs ............................................... Tested monthly, not to exceed 6 weeks. Valves must be tested for both operation and leakage. You must test according to API RP 14H for SSVs (incorporated by reference as specified in § 250.198). If a BSDV does not operate properly or if any fluid flow is observed during the leakage test, the valve must be immediately repaired or replaced. (iv) Electronic ESD logic .......................... Tested monthly, not to exceed 6 weeks. (v) Electronic ESD function ..................... Tested quarterly, not to exceed 120 days. Shut-in at least one well during the ESD function test. If multiple wells are tied back to the same platform, a different well should be shut-in with each quarterly test. [FR Doc. C1–2013–19861 Filed 9–3–13; 8:45 am] BILLING CODE 1505–01–D 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 Centers for Disease Control and Prevention, HHS. ACTION: Request for comment and notice of public meeting. AGENCY: 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 NIOSHcertified non-powered air-purifying particulate respirators approved as halffacepiece 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 tkelley on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 18:08 Sep 03, 2013 Jkt 229001 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: https:// 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 https:// www.regulations.gov. Docket: For access to the docket to read background documents and submitted comments, go to https:// 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- PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 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 E:\FR\FM\04SEP1.SGM 04SEP1 Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Proposed Rules 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 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 peerreviewed 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 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. tkelley on DSK3SPTVN1PROD with PROPOSALS 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 halffacepiece 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. 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 Halfmask Air-purifying Particulate Respirators. Procedure No. RCT–APR–STP–0068. Available at https://www.cdc.gov/niosh/docket/archive/pdfs/ NIOSH-137/0137-081209-DraftTIL.pdf. 3 Presentation slides for both webinars are found in the dockets for this action. VerDate Mar<15>2010 18:08 Sep 03, 2013 Jkt 229001 54433 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 inperson 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 governmentissued photo ID will be required to obtain entrance to the facility. Non-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 https:// www.cdc.gov/niosh/npptl/resources/ pressrel/letters/lttr-09172013.html. (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 quartermasks? If you represent a respirator manufacturer, do you currently market quarter-mask respirators? If you are a purchaser, do you currently use quartermask respirators? Please include a description of the occupational use of the quarter-mask respirators you are manufacturing or using. IV. Questions for Stakeholders 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 halffacepiece panel 4)? Please explain your answer. 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)), 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. PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 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 https://www.cdc.gov/niosh/npptl/stps/pdfs/TEBAPR-STP-0005-05a-06.pdf. E:\FR\FM\04SEP1.SGM 04SEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 54434 Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Proposed Rules 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 halfmask 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 VerDate Mar<15>2010 18:08 Sep 03, 2013 Jkt 229001 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] BILLING CODE P OFFICE OF PERSONNEL MANAGEMENT 5 CFR Parts 300, 315, 335, 410, 537, and 900 RIN 3206–AM77 Nondiscrimination Provisions U.S. Office of Personnel Management. ACTION: Proposed rule. AGENCY: The Office of Personnel Management (OPM) is proposing to update various nondiscrimination provisions appearing in title 5, Code of Federal Regulations, to provide greater consistency and reflect current law. DATES: Comments must be received on or before November 4, 2013. ADDRESSES: Send or deliver comments to U.S. Office of Personnel Management, Office of Diversity & Inclusion, 1900 E SUMMARY: PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 Street NW., Washington, DC 20415; email to diversityandinclusion@ opm.gov; or fax to (202) 606–6042. Comments may also be sent through the Federal eRulemaking Portal at https:// www.regulations.gov. All submissions received through the Portal must include the agency name and docket number or the Regulation Identifier Number (RIN) for this rulemaking. Please specify the section number for each comment. FOR FURTHER INFORMATION CONTACT: Contact Sharon Wong by telephone at (202) 606–7140; by TTY at 1–800–877– 8339; by fax at (202) 606–6042; or by email at diversityandinclusion@ opm.gov. SUPPLEMENTARY INFORMATION: Executive Order 13563 directs agencies to promote ‘‘retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.’’ Pursuant to that direction and OPM’s plan for conducting retrospective review (see https://www.opm.gov/Open/ Resources/RetrospectiveRegReview.pdf), OPM has been reviewing a number of existing regulations to determine whether they should be changed or eliminated. Among the regulations OPM has decided to review are those that contain nondiscrimination provisions. OPM chose these regulations for retrospective review to further respond to a separate instruction issued by President Obama in a June 17, 2009, Memorandum on Federal Benefits and Nondiscrimination. That memorandum directed OPM to issue guidance ‘‘regarding compliance with, and implementation of, the civil service laws, rules, and regulations, including 5 U.S.C. 2302(b)(10), which make it unlawful to discriminate against Federal employees or applicants for Federal employment on the basis of factors not related to job performance.’’ See https://www.whitehouse.gov/the-pressoffice/memorandum-heads-executivedepartments-and-agencies-federalbenefits-and-non-discri. Our review revealed that the nondiscrimination provisions are inconsistently worded and most have not been updated to reflect recent legal developments, including enactment of the Genetic Information Nondiscrimination Act of 2008 (GINA), Pub. L. 110–233, which prohibits discrimination on the basis of genetic information. Accordingly, we are issuing these proposed regulations to update the nondiscrimination provisions to reflect current law and to E:\FR\FM\04SEP1.SGM 04SEP1

Agencies

[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Proposed Rules]
[Pages 54432-54434]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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: https://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 https://www.regulations.gov.
    Docket: For access to the docket to read background documents and 
submitted comments, go to https://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\
---------------------------------------------------------------------------

    \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 https://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-137/0137-081209-DraftTIL.pdf.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \3\ Presentation slides for both webinars are found in the 
dockets for this action.
---------------------------------------------------------------------------

    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 https://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.
---------------------------------------------------------------------------

    \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 https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0005-05a-06.pdf.
---------------------------------------------------------------------------

    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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