[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95623-95625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31393]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Closed-Circuit Escape Respirators; Guidance for Industry; 
Availability

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of availability.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH), within the Centers for Disease Control and Prevention, 
Department of Health and Human Services, announces publication of a 
guidance document which 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. Pursuant to a Federal 
Register notice published on February 10, 2016, beginning on January 4, 
2017, manufacturers are 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 (81 FR 7121). 
This guidance announces that NIOSH does not intend 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 existing NIOSH regulation.

DATES: NIOSH is soliciting public comment, but is implementing this 
guidance immediately because NIOSH has determined that prior public 
participation is not feasible or appropriate. Comments must be received 
by February 27, 2017.

ADDRESSES: You may submit comments, identified by ``CDC-2016-0121'' by 
any of the following methods:
    Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
    Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, 
Cincinnati, OH 45226-1998.
    Instructions: All submissions received must include the agency name 
and docket number for this guidance. All relevant comments will be 
posted without change to http://www.regulations.gov including any 
personal information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

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: Pursuant to the Federal Mine Safety and 
Health Act of 1977, at 30 U.S.C. 957, NIOSH is authorized to promulgate 
regulations to carry out its duties mandated by such Act. Under 42 CFR 
part 84--Approval of Respiratory Protective Devices, NIOSH approves 
respirators used by workers in mines and other workplaces for 
protection against hazardous atmospheres.\1\ The Department of

[[Page 95624]]

Labor's Mine Safety and Health Administration (MSHA) requires U.S. mine 
operators to supply NIOSH/MSHA-approved respirators to miners whenever 
the use of escape respirators is required.
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    \1\ The cited statutory authorities for Part 84 are 29 U.S.C. 
651 et seq. and 657(g), and 30 U.S.C. 3, 5, 7, 811, 842(h), 844.
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    The self-contained self-rescuer (SCSR) approved under 42 CFR part 
84, Subpart H, and closed-circuit escape respirator (CCER) approved 
under 42 CFR part 84, Subpart O reflect two generations of the same 
respirator used in certain industrial and other work settings during 
emergencies to enable users to escape from atmospheres that can be 
immediately dangerous to life and health. The SCSR/CCER is used by 
miners to escape dangerous atmospheres in mines.
    Standards for the approval of CCERs were updated in a final rule 
published March 8, 2012, in which HHS codified a new Subpart O and 
removed only those technical requirements in 42 CFR part 84--Subpart H 
that were uniquely applicable to CCERs (77 FR 14168). All other 
applicable requirements of 42 CFR part 84 were unchanged. The purpose 
of these updated requirements is to enable NIOSH and MSHA to more 
effectively ensure the performance, reliability, and safety of CCERs 
used in underground coal mining. The March 2012 rulemaking was 
conducted in response to decades of reports from the field, 
particularly underground coal mines, documenting user concerns about 
the inability to inspect Subpart H-approved SCSRs for internal damage 
and the damage sustained to such devices in harsh underground 
environments. Furthermore, incidents in which wearers did not receive 
the expected duration of breathing air were common. The former Subpart 
H performance rating system classified SCSRs by the duration of 
breathing air, and was widely known to create confusion among users. 
Performance duration is not fixed and is dependent on a variety of 
factors which might result in less protection time than the wearer 
expects. As HHS said in the March 2012 final rule, ``[t]he . . . 
duration rating is misleading and potentially dangerous to users'' (77 
FR 14168 at 14177). The disaster at the Sago Mine in 2006, in which 12 
miners died and another was critically injured, accelerated the 
promulgation of the Subpart O standards with encouragement from the 
United Mine Workers of America;\2\ with improved respirator 
functionality and a better-applied rating system, the outcome might 
have been different. The need for the rulemaking is discussed in 
greater detail in the March 2012 final rule (see 77 FR 14168 at 14169-
14182), and background documents, including public comments, are 
available in NIOSH Docket 005.
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    \2\ See NIOSH Docket 005 for background materials related to the 
March 2012 rulemaking, http://www.cdc.gov/niosh/docket/archive/docket005.html. According to UMWA, in a January 2, 2006 publication, 
Report on the Sago Mine Disaster, ``[c]urrent SCSR technology is 
almost 20 years old. The federal and state governments, through MSHA 
and NIOSH, should actively pursue new SCSR technology. All 
stakeholders must be closely involved in the design, development and 
testing of these devices. The new generation of SCSRs must be 
longer-lasting, more reliable units . . .''
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    The Subpart O CCER standards established a classification system 
based on the quantity (capacity) of oxygen available in an escape 
respirator. For the purpose of comparing the SCSR to the CCER, a device 
classified as a ``10-minute'' SCSR under Subpart H may be approximately 
equivalent to a ``Cap 1'' CCER under Subpart O, delivering between 20 
and 59 liters of oxygen. A ``1-hour'' SCSR under Subpart H may be 
approximately equivalent to a ``Cap 3'' CCER under Subpart O, 
delivering at least 80 liters of oxygen. CCERs of any capacity used in 
mining are still required to pass the Subpart H ``man test 4.'' This 
test is used to demonstrate that CCERs used in mining will continue to 
meet the criteria established by MSHA in 30 CFR part 75 by providing a 
minimum duration of breathing air.
    Because NIOSH determined that the resulting advances in escape 
respirator performance and reliability warranted accelerated adoption 
of the enhanced standards, manufacturers were authorized to continue to 
manufacture, label, and sell Subpart H-approved SCSRs only until April 
9, 2015. The three-year period between April 9, 2012, and April 9, 
2015, was provided for manufacturers to obtain certificates of approval 
for CCER designs developed under the Subpart O standards. Beginning on 
April 10, 2012, no new applications for approval of Subpart H SCSRs 
have been accepted. However, manufacturers were unable to develop Cap 3 
CCERs in time to meet the April 9, 2015 transition deadline and, as a 
result, NIOSH initiated a rulemaking to extend the deadline. On August 
12, 2015, NIOSH issued a final rule extending the concluding date for 
the transition to the Subpart O standards to 1 year after the date that 
the first approval was granted to certain CCER models (80 FR 48268).\3\ 
On February 10, 2016, NIOSH issued a Federal Register notice announcing 
the first approval of a Cap 3 CCER on January 4, 2016, issued to Ocenco 
Incorporated (Ocenco) of Pleasant Prairie, Wisconsin. In accordance 
with the August 2015 final rule, respirator manufacturers were 
permitted to continue to manufacture, label, and sell, 1-hour Subpart 
H-approved escape respirators until January 4, 2017. The manufacturing, 
labeling, or sale of such devices subsequent to this date, however, 
could result in NIOSH revoking, for cause, the certificate of approval 
under 42 CFR 84.34 or 84.43(c). 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; \4\ however, 
MSHA has recently expressed concern that a market gap is imminent in 
the underground coal mining industry.\5\
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    \3\ See 42 CFR 84.301(a), which states that ``[t]he continued 
manufacturing, labeling, and sale of CCERs previously approved under 
subpart H is authorized for units intended to be used in mining 
applications with durations comparable to Cap 1 (all CCERs with a 
rated service time <=20 minutes), and units intended to be used in 
mining and non-mining applications with durations comparable to Cap 
3 (all CCERs with a rated service time >=50 minutes), until 1 year 
after the date of the first NIOSH approval of a respirator model 
under each respective category specified.''
    \4\ The maritime market, which includes the U.S. Navy, have been 
quick adopters of newly-approved 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.
    \5\ 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 notice and guidance.
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    In November 2016, the NIOSH National Personal Protective Technology 
Laboratory (NPPTL) had a series of communications with representatives 
from MSHA, the underground coal mine industry, and two respirator 
manufacturers concerning the ability of the current supply of person-
wearable escape respirators to allow the mining industry to comply with 
MSHA regulations. Specifically, all but one of the manufacturers 
expressed concern that, without continued authorization to manufacture, 
label, and sell 1-hour, person-wearable SCSRs, manufacturers would be 
unable to fulfill the unmet needs of the underground coal mines that 
require the use of 1-hour person-wearable devices to satisfy MSHA 
regulatory requirements.\6\
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    \6\ NIOSH and MSHA received a letter on December 12, 2016 from 
Ocenco Incorporated stating its opposition to extension of the 
January 4, 2017 deadline for the sale of Subpart H-approved SCSR 
devices. Steven K. Berning, Ocenco Incorporated, letter to Mr. 
Joseph A. Main, Assistant Secretary of Labor, MSHA and [Dr.] John 
Howard, Director, NIOSH, December 12, 2016.
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    MSHA regulations require that two ``approved self-rescue device or

[[Page 95625]]

devices'' each sufficient to provide at least one hour of protection be 
available to every person underground in a coal mine; \7\ at least one 
escape respirator of any size must be ``worn or carried at all times by 
each person when underground.'' \8\ Mine operators are allowed the 
discretion to determine whether to require miners to carry a 1-hour 
respirator and cache at least one additional 1-hour respirator per 
miner, or carry a 10-minute respirator and cache two additional 1-hour 
units.\9\ MSHA and others argue that although both CSE Corporation, of 
Export, Pennsylvania, and Ocenco hold approvals for Cap 3 CCERs for 
mining, neither is person-wearable. Both Ocenco and Avon Polymer 
Products, Ltd., of Cadillac, Michigan offer approved Cap 1 mining CCERs 
which are person-wearable, but provide only 10 minutes of oxygen under 
the current approval requirements.
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    \7\ 30 CFR 75.1714(a), 75.1714-4.
    \8\ 30 CFR 75.1714-2(b).
    \9\ 30 CFR 75.1714-1(a) and (b).
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    According to MSHA,\10\ in many underground coal mines, miners 
traveling to multiple stations underground during their shift may not 
presently have access to caches with 1-hour respirators (as required by 
MSHA regulations), and therefore must be provided with a 1-hour or Cap 
3 person-wearable escape respirator to be in compliance and ensure 
their safety. MSHA also indicates that miners may have to search for a 
cache of escape respirators during an emergency, and if so, the lack of 
a person-worn, 1-hour SCSR or Cap 3 CCER would constitute a reduction 
in protection since they would have less time to find a cache. 
Accordingly, although the newly-approved Subpart O CCERs meet the 
higher performance requirements of the new standard, MSHA is concerned 
that the protection offered to miners currently wearing the 1-hour SRLD 
would be diminished if they were required to switch to a 10-minute 
person-wearable Subpart O CCER. MSHA further asserts that data on 
escape respirators deployed in underground coal mines indicate that in 
mines that rely on 1-hour person-wearable respirators, a substantial 
portion of their respirator inventory will reach the end of its service 
life in 2017 and 2018. According to MSHA, these will need to be 
replaced with additional belt-wearable 1-hour SRLDs since there are 
currently no available Cap 3 CCERs that are belt or person-wearable. 
Accordingly, MSHA has asked that NIOSH extend the deadline.
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    \10\ Supra note 5.

    In a letter to NPPTL, CSE Corporation, manufacturer of the 1-hour 
belt-wearable SCSR model SRLD, reported similar concerns among its 
mining industry customers.\11\ According to CSE,
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    \11\ Scott Shearer, CSE Corporation, letter to Maryann 
D'Alessandro, Director, NPPTL, Subject: Cap 3 Closed-Circuit Escape 
Respirators Transition Plan, November 4, 2016. This letter is 
available in the docket for this notice and guidance.
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[a] large portion of the previous generation SCSR population 
utilized by the mining industry will reach their Service Life Date 
(Expire) between 2017 through to 2019. Numerous individuals from the 
mining industry have expressed concerns that an adequate supply of 
Cap 3 CCERs will NOT be available to replace the expiring SCSRs.\12\ 
[emphasis in original]
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    \12\ Id.

    On behalf of its customers, CSE expressed two primary concerns: (1) 
``how to implement the new Cap 3 CCER technology under the current 
budgetary constraints,'' and (2) ``the Cap 3 CCER technology is so new 
that many in the mining industry have not had the opportunity to 
evaluate it as related to their operational needs let alone even see a 
new Cap 3 CCER.'' CSE concluded that, ``[a]s a result of these 
concerns, many in the mining industry have not fully issued purchase 
orders for either technology SCSR or Cap 3 CCER to replace the expiring 
SCSRs.'' CSE received NIOSH approval for its Cap 3 mining CCER on March 
28, 2016,\13\ and plans to be in full production in May 2017. CSE has 
since informed NIOSH that it has a backlog of orders for Subpart H 
SCSRs, which it is unable to fill before the January 4, 2017 
manufacturing deadline.
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    \13\ See NIOSH National Personal Protective Technology 
Laboratory Certified Equipment List, https://www2a.cdc.gov/drds/cel/cel_form_code.asp.
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    Finally, a mining industry representative communicated with NPPTL 
to register similar concern about the availability of the SRLD.\14\
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    \14\ Allen Dupree, Contura Energy, letter to Maryann 
D'Alessandro, November 23, 2016, Subject: Concerns regarding SCSR 
Rule. This letter is available in the docket for this notice and 
guidance.
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    After consideration of the concerns described above, NIOSH agrees 
that allowing the continued manufacturing, labeling, and sale of 1-hour 
Subpart H SCSRs is important for the continued respiratory protection 
of certain underground coal miners and necessary until such time as a 
person-wearable Cap 3 CCER is developed to replace it. Accordingly, 
NIOSH has published a guidance document, entitled ``Closed-Circuit 
Escape Respirators; 42 CFR part 84, Subpart O Compliance; Guidance for 
Industry,'' on the NIOSH National Personal Protective Technology 
Laboratory Web site, at www.cdc.gov/niosh/npptl. The guidance explains 
the conditions under which NIOSH does not intend 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), including misuse 
of approval labels and markings, misleading advertising, and failure to 
maintain or cause to be maintained the applicable quality control 
requirements.\15\
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    \15\ See 42 CFR 84.34, which states that ``[t]he Institute 
reserves the right to revoke, for cause, any certificate of approval 
issued pursuant to the provisions of this part. Such causes include, 
but are not limited to, misuse of approval labels and markings, 
misleading advertising, and failure to maintain or cause to be 
maintained the quality control requirements of the certificate of 
approval.''). See also 42 CFR 84.43(c), which states that ``[t]he 
Institute reserves the right to revoke, for cause, any certificate 
of approval where it is found that the applicant's quality control 
test methods, equipment, or records do not ensure effective quality 
control over the respirator for which the approval was issued.''
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    This policy does not extend to any other NIOSH regulatory 
requirement for respirator approval in 42 CFR part 84.
    To ensure that underground coal miners have sufficient MSHA-
required protection during escape from hazardous atmospheres, the 
guidance is effective immediately. The guidance represents the current 
thinking of NIOSH on this topic. It does not establish any rights for 
any person and is not binding on NIOSH or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. To discuss an alternative approach, contact 
the NIOSH staff responsible for this guidance.

    Dated: December 21, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-31393 Filed 12-27-16; 8:45 am]
 BILLING CODE 4163-19-P