[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)]
[Notices]
[Pages 18002-18004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07587]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket Number CDC-2016-0121; NIOSH-285]


Closed-Circuit Escape Respirators; Final Guidance for Industry; 
Availability

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of availability.

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SUMMARY: On December 28, 2016, the National Institute for Occupational 
Safety and Health (NIOSH), within the Centers for Disease Control and 
Prevention, Department of Health and Human Services, published a notice 
in the Federal Register announcing the availability of an interim 
guidance document addressing the availability of closed-circuit escape 
respirators (CCERs) for purchase, and the readiness of respirator 
manufacturers to comply with the regulatory provisions

[[Page 18003]]

addressing these respirators. After consideration of public comments, 
NIOSH has revised the guidance and now announces that NIOSH does not 
intend to revoke any certificate of approval for any escape respirator 
approved for use in mining in accordance with NIOSH regulations, that 
are manufactured, labeled, or sold prior to June 1, 2019, provided that 
th.ere is no cause for revocation under existing NIOSH regulation.

DATES: The final guidance announced in this Federal Register notice is 
effective on April 14, 2017.

FOR FURTHER INFORMATION CONTACT: Maryann D'Alessandro, NIOSH National 
Personal Protective Technology Laboratory, 626 Cochrans Mill Road, 
Pittsburgh, PA 15236; 1-888-654-2294 (this is a toll-free phone 
number); [email protected].

SUPPLEMENTARY INFORMATION: The final guidance announced in this notice 
addresses the availability of closed-circuit escape respirators (CCERs) 
for purchase and the readiness of respirator manufacturers to comply 
with the provisions in Part 84, Subpart O, of Title 42 of the Code of 
Federal Regulations (CFR). Pursuant to a Federal Register notice 
published on February 10, 2016, beginning on January 4, 2017, 
manufacturers were no longer authorized to manufacture, label, and sell 
1-hour escape respirators, known in the mining community as self-
contained self-rescuers (SCSRs), approved in accordance with the 
certification testing standards in Part 84, Subpart H.\1\ Beginning on 
May 14, 2016, manufacturers were no longer authorized to manufacture, 
label, or sell 10-minute escape respirators for use in mining approved 
pursuant to Subpart H.\2\
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    \1\ 81 FR 7121.
    \2\ See NIOSH final rule, Closed-Circuit Escape Respirators; 
Extension of Transition Period, 80 FR 48268 (August 12, 2015).
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    In an interim guidance document published on December 28, 2016,\3\ 
NIOSH announced its intention not to revoke any certificate of approval 
for 1-hour escape respirators approved in accordance with 42 CFR part 
84, Subpart H, that are manufactured, labeled, or sold prior to January 
4, 2018, provided that there is no cause for revocation under 42 CFR 
84.34 or 84.43(c). Upon consideration of public comments submitted to 
the docket for this action, NIOSH has reconsidered the scope of the 
guidance as well as the compliance deadline.\4\ The final guidance is 
summarized below. The full final guidance, entitled ``Closed-Circuit 
Escape Respirators Approved for Use in Mining, 42 CFR part 84, Subpart 
O Compliance; Guidance for Industry; Final'' is available on the NIOSH 
National Personal Protective Technology Web site at www.cdc.gov/niosh/npptl.
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    \3\ The December 2016 guidance was announced in a Federal 
Register notice published on December 28, 2016 (81 FR 95623).
    \4\ One public commenter asked that we extend the comment period 
for this action. Although we are closing the comment period for this 
final guidance, we are considering additional steps, such as a 
public meeting, to continue a dialog with stakeholders concerning 
the implementation of the CCER standards in 42 CFR part 84, Subpart 
O.
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    Standards for the approval of CCERs were updated in a final rule 
published March 8, 2012, in which HHS codified the new Subpart O and 
removed only those technical requirements in 42 CFR part 84, Subpart H 
that were uniquely applicable to CCERs.\5\ All other applicable 
requirements of 42 CFR part 84 were unchanged. The purpose of these 
updated requirements is to enable NIOSH and the Mine Safety and Health 
Administration (MSHA), which co-approves respirators used in 
underground coal mining, respirator manufacturers, and ultimately, 
respirator users, to more effectively ensure the performance, 
reliability, and safety of CCERs used in all workplace applications.\6\ 
The March 2012 final rule established a sunset provision for the 
Subpart H standards on April 9, 2015, three years after the final 
rule's effective date; the three-year period was intended to provide 
sufficient time for manufacturers to obtain certificates of approval 
for CCER designs developed under the Subpart O standards. Since April 
10, 2012, no new applications for approval of Subpart H SCSRs have been 
accepted.
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    \5\ 77 FR 14168.
    \6\ See 77 FR 14168 at 14169-14182 to read the background for 
this rulemaking; additional background materials as well as public 
comments are available in NIOSH Docket 005.
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    However, manufacturers did not develop small capacity CCERs 
approved for use in mining or large capacity CCERs approved for use in 
non-mining and mining in time to meet the April 2015 transition 
deadline and, as a result, NIOSH ultimately extended the deadline to 
one year after the date that the first approval was granted to those 
CCER models.\7\ Under this deadline extension formula, manufacturers 
were authorized to continue the manufacturing, labeling, and sale of 
10-minute Subpart H escape respirators approved for use in mining until 
May 13, 2016 and 1-hour Subpart H escape respirators for use in mining 
until January 4, 2017.
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    \7\ 80 FR 4801 (January 29, 2015).
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    The deadline extensions have contributed to the availability of new 
escape respirator designs which conform to the Subpart O requirements, 
and have addressed the needs of certain broad segments of the market 
for such devices; \8\ however, MSHA has recently expressed concern that 
a market gap is imminent in the underground coal mining industry.\9\ 
Further communications with stakeholders, including the underground 
coal mine industry and respirator manufacturers, some of whom submitted 
comments to the docket for this action, have indicated that the supply 
of Subpart O CCERs approved for use in mining are insufficient to meet 
the current needs of the mining industry.
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    \8\ The maritime market, which includes the U.S. Navy, have been 
quick adopters of newly-approved small capacity (Cap 1) CCERs (often 
referred to in that market as emergency escape breathing devices or 
EEBDs). Cap 1 CCERs which were available to replace Subpart H, 10-
minute approved apparatus are being deployed in that market segment 
in great numbers.
    \9\ Joe Main, Assistant Secretary of Labor, MSHA, letter to John 
Howard, Director, NIOSH, December 14, 2016. This letter is available 
in the docket for this guidance and corresponding Federal Register 
notice.
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    In order to allow mine operators access to all of the tools 
necessary to protect miners, to give respirator manufacturers time to 
develop a solution to the mine industry's desire for person-wearable 
Subpart O CCERs, and to ensure a smooth transition from the Subpart H 
to Subpart O approval standards, NIOSH does not intend to revoke any 
certificate of approval for escape respirators approved for use in 
mining in accordance with 42 CFR part 84, Subpart H, that are 
manufactured, labeled, or sold prior to June 1, 2019, provided that 
there is no cause for revocation under 42 CFR 84.34 or 84.43(c), 
including misuse of approval labels and markings, misleading 
advertising, and failure to maintain or cause to be maintained the 
applicable quality control requirements.
    The final guidance, available on the NIOSH National Personal 
Protective Technology Web site, does not create any new deadlines or 
waive any existing deadlines. The final guidance is not an 
interpretation of 42 CFR 84.301(a), it is a policy statement regarding 
NIOSH's intent to not revoke, except for cause, any certificate of 
approval for escape respirators approved for use in mining in 
accordance with 42 CFR part 84,

[[Page 18004]]

Subpart H, that are manufactured, labeled, or sold prior to June 1, 
2019.

Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-07587 Filed 4-13-17; 8:45 am]
 BILLING CODE 4163-19-P