[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Proposed Rules]
[Page 54315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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30, 2009, at 74 FR 56141, is withdrawn.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