[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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 . . .''
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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,
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[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]
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\13\ See NIOSH National Personal Protective Technology
Laboratory Certified Equipment List, https://www2a.cdc.gov/drds/cel/cel_form_code.asp.
---------------------------------------------------------------------------
Finally, a mining industry representative communicated with NPPTL
to register similar concern about the availability of the SRLD.\14\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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