82 FR 54315 - Total Inward Leakage Requirements for Respirators

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 221 (November 17, 2017)

Page Range		54315-54315
FR Document		2017-24950

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for half- mask, air-purifying particulate respirators approved by NIOSH.

Federal Register, Volume 82 Issue 221 (Friday, November 17, 2017)

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Proposed Rules]
[Page 54315]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket No. HHS-OS-2009-0019; NIOSH-0137]
RIN 0920-AA33


Total Inward Leakage Requirements for Respirators

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking; withdrawal.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS) announces the 
withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 
NPRM proposed to establish total inward leakage requirements for half-
mask, air-purifying particulate respirators approved by NIOSH.

DATES: As of November 17, 2017, the proposed rule published on October 
30, 2009, at 74 FR 56141, is withdrawn.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Office of the Director, 
National Institute for Occupational Safety and Health, 1090 Tusculum 
Avenue, MS-C46, Cincinnati, OH 45226. Telephone: (855) 818-1629 (this 
is a toll-free number); email: [email protected].

SUPPLEMENTARY INFORMATION: On October 30, 2009, HHS published an NPRM 
(74 FR 56141) that proposed to establish total inward leakage 
requirements for half-mask, air-purifying particulate respirators 
approved by NIOSH under regulations found in 42 CFR part 84. The NPRM 
included a 60-day comment period closing on December 29, 2009, which 
was eventually extended to September 30, 2010 (April 20, 2010, 75 FR 
20546).
    In response to the proposed rule, HHS received comments from five 
respirator manufacturers, one manufacturer of laboratory test 
equipment, two labor unions, one trade organization, one state's 
departments of public health and occupational safety and health, three 
consulting firms, and three private individuals in the field of 
respiratory protection. Stakeholders presented evidence that the 
approval decision outcomes could vary significantly between human 
subject panels that would be constituted according to the proposed test 
protocol, and expressed concern that the proposed approval requirements 
would not improve the performance of NIOSH-approved respirators on the 
market and might eliminate good-performing respirators from the market. 
Stakeholders also expressed concern that the cost of conducting inward 
leakage testing using the protocol proposed by NIOSH would be 
prohibitive and that costs would likely outweigh benefits.
    As a result of the stakeholder input submitted to the docket and 
during public meetings, NIOSH decided instead to pursue improved inward 
leakage performance of this class of respirators through participation 
in national and international consensus standard development efforts, 
rather than rulemaking. Thus, HHS finds that the public interest is 
best served by withdrawing the 2009 total inward leakage NPRM. The 
withdrawal of the 2009 total inward leakage NPRM does not preclude HHS 
from initiating future rulemaking concerning total inward leakage 
requirements for half-mask, air-purifying particulate respirators.
    The NPRM published on October 30, 2009 (74 FR 56141) is hereby 
withdrawn.

    Dated: November 13, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-24950 Filed 11-16-17; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Proposed Rules 54315

avian influenza viruses to mitigate the SUMMARY: The National Institute for evidence that the approval decision
risk to public health and safety. Thus, Occupational Safety and Health outcomes could vary significantly
HHS/CDC believes the public interest is (NIOSH), Centers for Disease Control between human subject panels that
best served by the withdrawal of the and Prevention (CDC), located within would be constituted according to the
NPRM identified in this document. The the Department of Health and Human proposed test protocol, and expressed
withdrawal of the proposed rule Services (HHS) announces the concern that the proposed approval
identified in this document does not withdrawal of its 2009 notice of requirements would not improve the
preclude HHS/CDC from initiating proposed rulemaking (NPRM). The 2009 performance of NIOSH-approved
future rulemaking concerning the NPRM proposed to establish total respirators on the market and might
influenza viruses that contain the inward leakage requirements for half- eliminate good-performing respirators
hemagglutinin (HA) from the Goose mask, air-purifying particulate from the market. Stakeholders also
Guangdong/1/96 lineage (the influenza respirators approved by NIOSH.
viruses that contain the hemagglutinin expressed concern that the cost of
DATES: As of November 17, 2017, the conducting inward leakage testing using
(HA) from the A/Gs/Gd/1/96 lineage), proposed rule published on October 30,
including wild-type viruses or influenza the protocol proposed by NIOSH would
2009, at 74 FR 56141, is withdrawn. be prohibitive and that costs would
viruses that contain the HA from the A/
FOR FURTHER INFORMATION CONTACT: likely outweigh benefits.
Gs/Gd/1/96 lineage that were made
Rachel Weiss, Office of the Director,
transmissible among mammals by As a result of the stakeholder input
National Institute for Occupational
respiratory droplets. submitted to the docket and during
The NPRM published on July 16, 2015 Safety and Health, 1090 Tusculum
Avenue, MS–C46, Cincinnati, OH public meetings, NIOSH decided
(82 FR 42079), is hereby withdrawn. instead to pursue improved inward
45226. Telephone: (855) 818–1629 (this
Dated: November 13, 2017. is a toll-free number); email: leakage performance of this class of
Eric D. Hargan, NIOSHregs@cdc.gov. respirators through participation in
Acting Secretary, Department of Health and SUPPLEMENTARY INFORMATION: On national and international consensus
Human Services. standard development efforts, rather
October 30, 2009, HHS published an
[FR Doc. 2017–24952 Filed 11–16–17; 8:45 am] NPRM (74 FR 56141) that proposed to than rulemaking. Thus, HHS finds that
BILLING CODE 4163–18–P establish total inward leakage the public interest is best served by
requirements for half-mask, air- withdrawing the 2009 total inward
purifying particulate respirators leakage NPRM. The withdrawal of the
DEPARTMENT OF HEALTH AND 2009 total inward leakage NPRM does
approved by NIOSH under regulations
HUMAN SERVICES not preclude HHS from initiating future
found in 42 CFR part 84. The NPRM
42 CFR Part 84 included a 60-day comment period rulemaking concerning total inward
closing on December 29, 2009, which leakage requirements for half-mask, air-
[Docket No. HHS–OS–2009–0019; NIOSH– was eventually extended to September purifying particulate respirators.
0137] 30, 2010 (April 20, 2010, 75 FR 20546). The NPRM published on October 30,
RIN 0920–AA33 In response to the proposed rule, HHS
2009 (74 FR 56141) is hereby
received comments from five respirator
Total Inward Leakage Requirements withdrawn.
manufacturers, one manufacturer of
for Respirators laboratory test equipment, two labor Dated: November 13, 2017.
AGENCY: Centers for Disease Control and unions, one trade organization, one Eric D. Hargan,
Prevention (CDC), Department of Health state’s departments of public health and Acting Secretary, Department of Health and
and Human Services (HHS). occupational safety and health, three Human Services.
consulting firms, and three private [FR Doc. 2017–24950 Filed 11–16–17; 8:45 am]
ACTION: Notice of proposed rulemaking;
individuals in the field of respiratory
withdrawal. BILLING CODE 4163–18–P
protection. Stakeholders presented
rmajette on DSKBCKNHB2PROD with PROPOSALS

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Document Created: 2017-11-17 05:14:37
Document Modified: 2017-11-17 05:14:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of proposed rulemaking; withdrawal.
Dates		As of November 17, 2017, the proposed rule published on October 30, 2009, at 74 FR 56141, is withdrawn.
Contact		Rachel Weiss, Office of the Director, National Institute for Occupational Safety and Health, 1090 Tusculum Avenue, MS-C46, Cincinnati, OH 45226. Telephone: (855) 818-1629 (this is a toll-free number); email: [email protected]
FR Citation		82 FR 54315
RIN Number		0920-AA33