81_FR_95872 81 FR 95623 - Closed-Circuit Escape Respirators; Guidance for Industry; Availability

81 FR 95623 - Closed-Circuit Escape Respirators; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 249 (December 28, 2016)

Page Range95623-95625
FR Document2016-31393

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.

Federal Register, Volume 81 Issue 249 (Wednesday, December 28, 2016)
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95623-95625]
From the Federal Register Online  [www.thefederalregister.org]
[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.
---------------------------------------------------------------------------

    \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]
---------------------------------------------------------------------------

    \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\
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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



                                                                         Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices                                                      95623

                                                are led by Regional Managers who                        in developing negotiation, enforcement,               Register notice published on February
                                                report to the Deputy Director for ORD                   and litigation strategies; promulgates                10, 2016, beginning on January 4, 2017,
                                                and are responsible for civil rights and                regulations, policies, and guidance and               manufacturers are no longer authorized
                                                HIPAA complaint investigations,                         provides technical assistance to assist               to manufacture, label, and sell 1-hour
                                                enforcement, and outreach. ORD is                       covered entities with compliance; and                 escape respirators, known in the mining
                                                responsible for responding to                           provides subject matter expertise for                 community as self-contained self-
                                                stakeholder calls and triaging civil                    public education and outreach activities              rescuers (SCSRs), approved in
                                                rights and HIPAA complaints at intake.                  to stakeholders nationwide. The                       accordance with the certification testing
                                                   C. Civil Rights Division (ATB). The                  Division also identifies OCR training                 standards in Part 84, Subpart H (81 FR
                                                Civil Rights Division is headed by the                  needs and designs HIPAA and PSQIA                     7121). This guidance announces that
                                                Deputy Director for Civil Rights, who                   specific training programs for OCR staff;             NIOSH does not intend to revoke any
                                                reports to the Director. The Civil Rights               reviews challenges to OCR’s regional                  certificate of approval for 1-hour escape
                                                Division oversees OCR’s national civil                  offices’ HIPAA investigative findings;                respirators, approved in accordance
                                                rights program, including Section 1557                  leads national HIPAA compliance                       with 42 CFR part 84, Subpart H, that are
                                                of the Affordable Care Act, as well as                  reviews, including audits; and liaises                manufactured, labeled, or sold prior to
                                                other federal civil rights statutes and                 with and provides technical assistance                January 4, 2018, provided that there is
                                                regulations that prohibit non-                          and advisory services to HHS OPDIVS,                  no cause for revocation under existing
                                                discrimination on the basis of race,                    as well as national advocacy,                         NIOSH regulation.
                                                color, national original, sex, disability,              beneficiary, and provider groups, and to              DATES: NIOSH is soliciting public
                                                and age; the Division also enforces                     other Federal departments and agencies                comment, but is implementing this
                                                provider conscience laws. The Civil                     with respect to health information                    guidance immediately because NIOSH
                                                Rights Division provides national                       privacy, security, and breach initiatives             has determined that prior public
                                                leadership in OCR’s enforcement and                     and mandates, including serving on                    participation is not feasible or
                                                compliance activities, including                        intra- and interagency workgroups.                    appropriate. Comments must be
                                                advising OCR staff nationwide on case                     III. Delegation of Authority. Pending               received by February 27, 2017.
                                                development and quality and assisting                   further delegation, directives or orders
                                                in developing negotiation, enforcement,                                                                       ADDRESSES: You may submit comments,
                                                                                                        by the Secretary or by the Director of the            identified by ‘‘CDC–2016–0121’’ by any
                                                and litigation strategies; promulgates                  Office for Civil Rights, all delegations
                                                regulations, policies, and guidance and                                                                       of the following methods:
                                                                                                        and re-delegations of authority made to                 Internet: Access the Federal e-
                                                provides technical assistance to assist                 officials and employees of affected
                                                covered entities with compliance; and                                                                         rulemaking portal at http://
                                                                                                        organizational components will                        www.regulations.gov. Follow the
                                                provides subject matter expertise for                   continue in them or their successors
                                                public education and outreach activities                                                                      instructions for submitting comments.
                                                                                                        pending further re-delegations, provided                Mail: NIOSH Docket Office, 1090
                                                to stakeholders nationwide. The Civil                   they are consistent with this
                                                Rights Division also leads national civil                                                                     Tusculum Avenue, MS C–34,
                                                                                                        reorganization.                                       Cincinnati, OH 45226–1998.
                                                rights compliance reviews; identifies
                                                and designs civil rights specific training                Dated: December 12, 2016.                             Instructions: All submissions received
                                                programs for OCR staff; reviews                         Colleen Barros,                                       must include the agency name and
                                                challenges to OCR’s regional civil rights               Acting Assistant Secretary for                        docket number for this guidance. All
                                                findings; coordinates OCR’s                             Administration.                                       relevant comments will be posted
                                                government-wide responsibilities for                    [FR Doc. 2016–31394 Filed 12–27–16; 8:45 am]          without change to http://
                                                implementation of Age Discrimination                    BILLING CODE 4153–01–P
                                                                                                                                                              www.regulations.gov including any
                                                Act requirements; and liaises with and                                                                        personal information provided.
                                                provides civil rights technical assistance                                                                      Docket: For access to the docket to
                                                and advisory services to HHS Operating                  DEPARTMENT OF HEALTH AND                              read background documents or
                                                Divisions, as well as national advocacy,                HUMAN SERVICES                                        comments received, go to http://
                                                beneficiary, and provider groups, and to                                                                      www.regulations.gov.
                                                                                                        [Docket Number CDC–2016–0121; NIOSH–
                                                other Federal departments and agencies,                 285]                                                  FOR FURTHER INFORMATION CONTACT:
                                                including serving on intra- and                                                                               Maryann D’Alessandro, NIOSH National
                                                interagency workgroups.                                 Closed-Circuit Escape Respirators;                    Personal Protective Technology
                                                   D. Health Information Privacy                        Guidance for Industry; Availability                   Laboratory, 626 Cochrans Mill Road,
                                                Division (ATC). The Health Information                                                                        Pittsburgh, PA 15236; 1–888–654–2294
                                                Privacy Division is headed by the                       AGENCY: Centers for Disease Control and               (this is a toll-free phone number);
                                                Deputy Director for Health Information                  Prevention, HHS.                                      PPEconcerns@cdc.gov.
                                                Privacy, who reports to the Director.                   ACTION: Notice of availability.                       SUPPLEMENTARY INFORMATION: Pursuant
                                                The Health Information Privacy                                                                                to the Federal Mine Safety and Health
                                                Division oversees OCR’s enforcement of                  SUMMARY:   The National Institute for                 Act of 1977, at 30 U.S.C. 957, NIOSH is
                                                the HIPAA Privacy, Security and Breach                  Occupational Safety and Health                        authorized to promulgate regulations to
                                                Notification Rules, as well as the                      (NIOSH), within the Centers for Disease               carry out its duties mandated by such
                                                confidentiality provisions of Section                   Control and Prevention, Department of                 Act. Under 42 CFR part 84—Approval of
                                                922 of the Public Health Service Act, as                Health and Human Services, announces                  Respiratory Protective Devices, NIOSH
                                                                                                        publication of a guidance document
sradovich on DSK3GMQ082PROD with NOTICES




                                                amended by the Patient Safety and                                                                             approves respirators used by workers in
                                                Quality Improvement Act of 2005                         which addresses the availability of                   mines and other workplaces for
                                                (PSQIA). The Health Information                         closed-circuit escape respirators                     protection against hazardous
                                                Privacy Division provides national                      (CCERs) for purchase and the readiness                atmospheres.1 The Department of
                                                leadership in OCR’s enforcement and                     of respirator manufacturers to comply
                                                compliance activities, including                        with the provisions in Part 84, Subpart                  1 The cited statutory authorities for Part 84 are 29
                                                advising OCR staff nationwide on case                   O, of Title 42 of the Code of Federal                 U.S.C. 651 et seq. and 657(g), and 30 U.S.C. 3, 5,
                                                development and quality and assisting                   Regulations. Pursuant to a Federal                    7, 811, 842(h), 844.



                                           VerDate Sep<11>2014   18:54 Dec 27, 2016   Jkt 241001   PO 00000   Frm 00069   Fmt 4703   Sfmt 4703   E:\FR\FM\28DEN1.SGM   28DEN1


                                                95624                    Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices

                                                Labor’s Mine Safety and Health                          improved respirator functionality and a                2016, NIOSH issued a Federal Register
                                                Administration (MSHA) requires U.S.                     better-applied rating system, the                      notice announcing the first approval of
                                                mine operators to supply NIOSH/                         outcome might have been different. The                 a Cap 3 CCER on January 4, 2016, issued
                                                MSHA-approved respirators to miners                     need for the rulemaking is discussed in                to Ocenco Incorporated (Ocenco) of
                                                whenever the use of escape respirators                  greater detail in the March 2012 final                 Pleasant Prairie, Wisconsin. In
                                                is required.                                            rule (see 77 FR 14168 at 14169–14182),                 accordance with the August 2015 final
                                                   The self-contained self-rescuer (SCSR)               and background documents, including                    rule, respirator manufacturers were
                                                approved under 42 CFR part 84, Subpart                  public comments, are available in                      permitted to continue to manufacture,
                                                H, and closed-circuit escape respirator                 NIOSH Docket 005.                                      label, and sell, 1-hour Subpart H-
                                                (CCER) approved under 42 CFR part 84,                      The Subpart O CCER standards                        approved escape respirators until
                                                Subpart O reflect two generations of the                established a classification system based              January 4, 2017. The manufacturing,
                                                same respirator used in certain                         on the quantity (capacity) of oxygen                   labeling, or sale of such devices
                                                industrial and other work settings                      available in an escape respirator. For the             subsequent to this date, however, could
                                                during emergencies to enable users to                   purpose of comparing the SCSR to the                   result in NIOSH revoking, for cause, the
                                                escape from atmospheres that can be                     CCER, a device classified as a ‘‘10-                   certificate of approval under 42 CFR
                                                immediately dangerous to life and                       minute’’ SCSR under Subpart H may be                   84.34 or 84.43(c). The deadline
                                                health. The SCSR/CCER is used by                        approximately equivalent to a ‘‘Cap 1’’                extensions have contributed to the
                                                miners to escape dangerous                              CCER under Subpart O, delivering                       availability of new escape respirator
                                                atmospheres in mines.                                   between 20 and 59 liters of oxygen. A                  designs which conform to the Subpart O
                                                   Standards for the approval of CCERs                  ‘‘1-hour’’ SCSR under Subpart H may be                 requirements, and have addressed the
                                                were updated in a final rule published                  approximately equivalent to a ‘‘Cap 3’’                needs of certain broad segments of the
                                                March 8, 2012, in which HHS codified                    CCER under Subpart O, delivering at                    market for such devices; 4 however,
                                                a new Subpart O and removed only                        least 80 liters of oxygen. CCERs of any                MSHA has recently expressed concern
                                                those technical requirements in 42 CFR                  capacity used in mining are still                      that a market gap is imminent in the
                                                part 84—Subpart H that were uniquely                    required to pass the Subpart H ‘‘man                   underground coal mining industry.5
                                                applicable to CCERs (77 FR 14168). All                  test 4.’’ This test is used to demonstrate                In November 2016, the NIOSH
                                                other applicable requirements of 42 CFR                 that CCERs used in mining will                         National Personal Protective
                                                part 84 were unchanged. The purpose of                  continue to meet the criteria established              Technology Laboratory (NPPTL) had a
                                                these updated requirements is to enable                 by MSHA in 30 CFR part 75 by                           series of communications with
                                                NIOSH and MSHA to more effectively                      providing a minimum duration of                        representatives from MSHA, the
                                                ensure the performance, reliability, and                breathing air.                                         underground coal mine industry, and
                                                safety of CCERs used in underground                        Because NIOSH determined that the                   two respirator manufacturers
                                                coal mining. The March 2012                             resulting advances in escape respirator                concerning the ability of the current
                                                rulemaking was conducted in response                    performance and reliability warranted                  supply of person-wearable escape
                                                to decades of reports from the field,                   accelerated adoption of the enhanced                   respirators to allow the mining industry
                                                particularly underground coal mines,                    standards, manufacturers were                          to comply with MSHA regulations.
                                                documenting user concerns about the                     authorized to continue to manufacture,                 Specifically, all but one of the
                                                inability to inspect Subpart H-approved                 label, and sell Subpart H-approved                     manufacturers expressed concern that,
                                                SCSRs for internal damage and the                       SCSRs only until April 9, 2015. The                    without continued authorization to
                                                damage sustained to such devices in                     three-year period between April 9, 2012,               manufacture, label, and sell 1-hour,
                                                harsh underground environments.                         and April 9, 2015, was provided for                    person-wearable SCSRs, manufacturers
                                                Furthermore, incidents in which                         manufacturers to obtain certificates of                would be unable to fulfill the unmet
                                                wearers did not receive the expected                    approval for CCER designs developed                    needs of the underground coal mines
                                                duration of breathing air were common.                  under the Subpart O standards.                         that require the use of 1-hour person-
                                                The former Subpart H performance                        Beginning on April 10, 2012, no new                    wearable devices to satisfy MSHA
                                                rating system classified SCSRs by the                   applications for approval of Subpart H                 regulatory requirements.6
                                                duration of breathing air, and was                      SCSRs have been accepted. However,                        MSHA regulations require that two
                                                widely known to create confusion                        manufacturers were unable to develop                   ‘‘approved self-rescue device or
                                                among users. Performance duration is                    Cap 3 CCERs in time to meet the April
                                                not fixed and is dependent on a variety                 9, 2015 transition deadline and, as a                  mining applications with durations comparable to
                                                of factors which might result in less                   result, NIOSH initiated a rulemaking to                Cap 3 (all CCERs with a rated service time ≥50
                                                                                                        extend the deadline. On August 12,                     minutes), until 1 year after the date of the first
                                                protection time than the wearer expects.                                                                       NIOSH approval of a respirator model under each
                                                As HHS said in the March 2012 final                     2015, NIOSH issued a final rule                        respective category specified.’’
                                                rule, ‘‘[t]he . . . duration rating is                  extending the concluding date for the                     4 The maritime market, which includes the U.S.

                                                misleading and potentially dangerous to                 transition to the Subpart O standards to               Navy, have been quick adopters of newly-approved
                                                users’’ (77 FR 14168 at 14177). The                     1 year after the date that the first                   Cap 1 CCERs (often referred to in that market as
                                                                                                                                                               emergency escape breathing devices or EEBDs). Cap
                                                disaster at the Sago Mine in 2006, in                   approval was granted to certain CCER                   1 CCERs which were available to replace Subpart
                                                which 12 miners died and another was                    models (80 FR 48268).3 On February 10,                 H, 10-minute approved apparatus are being
                                                critically injured, accelerated the                                                                            deployed in that market segment in great numbers.
                                                promulgation of the Subpart O                           and NIOSH, should actively pursue new SCSR                5 Joe Main, Assistant Secretary of Labor, MSHA,

                                                                                                        technology. All stakeholders must be closely           letter to John Howard, Director, NIOSH, December
                                                standards with encouragement from the                   involved in the design, development and testing of     14, 2016. This letter is available in the docket for
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                                                United Mine Workers of America;2 with                   these devices. The new generation of SCSRs must        this notice and guidance.
                                                                                                        be longer-lasting, more reliable units . . .’’            6 NIOSH and MSHA received a letter on
                                                   2 See NIOSH Docket 005 for background materials         3 See 42 CFR 84.301(a), which states that ‘‘[t]he   December 12, 2016 from Ocenco Incorporated
                                                related to the March 2012 rulemaking, http://           continued manufacturing, labeling, and sale of         stating its opposition to extension of the January 4,
                                                www.cdc.gov/niosh/docket/archive/docket005.html.        CCERs previously approved under subpart H is           2017 deadline for the sale of Subpart H-approved
                                                According to UMWA, in a January 2, 2006                 authorized for units intended to be used in mining     SCSR devices. Steven K. Berning, Ocenco
                                                publication, Report on the Sago Mine Disaster,          applications with durations comparable to Cap 1        Incorporated, letter to Mr. Joseph A. Main, Assistant
                                                ‘‘[c]urrent SCSR technology is almost 20 years old.     (all CCERs with a rated service time ≤20 minutes),     Secretary of Labor, MSHA and [Dr.] John Howard,
                                                The federal and state governments, through MSHA         and units intended to be used in mining and non-       Director, NIOSH, December 12, 2016.



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                                                                         Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices                                                       95625

                                                devices’’ each sufficient to provide at                 Accordingly, MSHA has asked that                      Industry,’’ on the NIOSH National
                                                least one hour of protection be available               NIOSH extend the deadline.                            Personal Protective Technology
                                                to every person underground in a coal                     In a letter to NPPTL, CSE Corporation,              Laboratory Web site, at www.cdc.gov/
                                                mine; 7 at least one escape respirator of               manufacturer of the 1-hour belt-                      niosh/npptl. The guidance explains the
                                                any size must be ‘‘worn or carried at all               wearable SCSR model SRLD, reported                    conditions under which NIOSH does
                                                times by each person when                               similar concerns among its mining                     not intend to revoke any certificate of
                                                underground.’’ 8 Mine operators are                     industry customers.11 According to CSE,               approval for 1-hour escape respirators,
                                                allowed the discretion to determine                     [a] large portion of the previous generation          approved in accordance with 42 CFR
                                                whether to require miners to carry a 1-                 SCSR population utilized by the mining                part 84, Subpart H, that are
                                                hour respirator and cache at least one                  industry will reach their Service Life Date           manufactured, labeled, or sold prior to
                                                additional 1-hour respirator per miner,                 (Expire) between 2017 through to 2019.                January 4, 2018, provided that there is
                                                                                                        Numerous individuals from the mining                  no cause for revocation under 42 CFR
                                                or carry a 10-minute respirator and
                                                                                                        industry have expressed concerns that an              84.34 or 84.43(c), including misuse of
                                                cache two additional 1-hour units.9                     adequate supply of Cap 3 CCERs will NOT
                                                MSHA and others argue that although                                                                           approval labels and markings,
                                                                                                        be available to replace the expiring SCSRs.12
                                                both CSE Corporation, of Export,                        [emphasis in original]                                misleading advertising, and failure to
                                                Pennsylvania, and Ocenco hold                                                                                 maintain or cause to be maintained the
                                                                                                           On behalf of its customers, CSE                    applicable quality control
                                                approvals for Cap 3 CCERs for mining,                   expressed two primary concerns: (1)
                                                neither is person-wearable. Both Ocenco                                                                       requirements.15
                                                                                                        ‘‘how to implement the new Cap 3                         This policy does not extend to any
                                                and Avon Polymer Products, Ltd., of                     CCER technology under the current                     other NIOSH regulatory requirement for
                                                Cadillac, Michigan offer approved Cap 1                 budgetary constraints,’’ and (2) ‘‘the Cap            respirator approval in 42 CFR part 84.
                                                mining CCERs which are person-                          3 CCER technology is so new that many                    To ensure that underground coal
                                                wearable, but provide only 10 minutes                   in the mining industry have not had the               miners have sufficient MSHA-required
                                                of oxygen under the current approval                    opportunity to evaluate it as related to              protection during escape from
                                                requirements.                                           their operational needs let alone even                hazardous atmospheres, the guidance is
                                                   According to MSHA,10 in many                         see a new Cap 3 CCER.’’ CSE concluded                 effective immediately. The guidance
                                                underground coal mines, miners                          that, ‘‘[a]s a result of these concerns,              represents the current thinking of
                                                traveling to multiple stations                          many in the mining industry have not                  NIOSH on this topic. It does not
                                                underground during their shift may not                  fully issued purchase orders for either               establish any rights for any person and
                                                presently have access to caches with 1-                 technology SCSR or Cap 3 CCER to                      is not binding on NIOSH or the public.
                                                hour respirators (as required by MSHA                   replace the expiring SCSRs.’’ CSE                     You can use an alternative approach if
                                                regulations), and therefore must be                     received NIOSH approval for its Cap 3                 it satisfies the requirements of the
                                                provided with a 1-hour or Cap 3 person-                 mining CCER on March 28, 2016,13 and                  applicable statutes and regulations. To
                                                wearable escape respirator to be in                     plans to be in full production in May                 discuss an alternative approach, contact
                                                compliance and ensure their safety.                     2017. CSE has since informed NIOSH                    the NIOSH staff responsible for this
                                                MSHA also indicates that miners may                     that it has a backlog of orders for                   guidance.
                                                have to search for a cache of escape                    Subpart H SCSRs, which it is unable to                  Dated: December 21, 2016.
                                                respirators during an emergency, and if                 fill before the January 4, 2017
                                                                                                                                                              Sylvia M. Burwell,
                                                so, the lack of a person-worn, 1-hour                   manufacturing deadline.
                                                                                                           Finally, a mining industry                         Secretary, Department of Health and Human
                                                SCSR or Cap 3 CCER would constitute                                                                           Services.
                                                a reduction in protection since they                    representative communicated with
                                                                                                        NPPTL to register similar concern about               [FR Doc. 2016–31393 Filed 12–27–16; 8:45 am]
                                                would have less time to find a cache.
                                                                                                        the availability of the SRLD.14                       BILLING CODE 4163–19–P
                                                Accordingly, although the newly-                           After consideration of the concerns
                                                approved Subpart O CCERs meet the                       described above, NIOSH agrees that
                                                higher performance requirements of the                  allowing the continued manufacturing,                 DEPARTMENT OF HOMELAND
                                                new standard, MSHA is concerned that                    labeling, and sale of 1-hour Subpart H                SECURITY
                                                the protection offered to miners                        SCSRs is important for the continued
                                                currently wearing the 1-hour SRLD                       respiratory protection of certain                     Coast Guard
                                                would be diminished if they were                        underground coal miners and necessary                 [Docket No. USCG–2016–1000]
                                                required to switch to a 10-minute                       until such time as a person-wearable
                                                person-wearable Subpart O CCER.                         Cap 3 CCER is developed to replace it.                Information Collection Request to
                                                MSHA further asserts that data on                       Accordingly, NIOSH has published a                    Office of Management and Budget;
                                                escape respirators deployed in                          guidance document, entitled ‘‘Closed-                 OMB Control Number: 1625–0025
                                                underground coal mines indicate that in                 Circuit Escape Respirators; 42 CFR part
                                                mines that rely on 1-hour person-                                                                             AGENCY:     Coast Guard, DHS.
                                                                                                        84, Subpart O Compliance; Guidance for
                                                wearable respirators, a substantial
                                                                                                                                                                15 See 42 CFR 84.34, which states that ‘‘[t]he
                                                portion of their respirator inventory will                 11 Scott Shearer, CSE Corporation, letter to
                                                                                                                                                              Institute reserves the right to revoke, for cause, any
                                                reach the end of its service life in 2017               Maryann D’Alessandro, Director, NPPTL, Subject:       certificate of approval issued pursuant to the
                                                and 2018. According to MSHA, these                      Cap 3 Closed-Circuit Escape Respirators Transition    provisions of this part. Such causes include, but are
                                                                                                        Plan, November 4, 2016. This letter is available in   not limited to, misuse of approval labels and
                                                will need to be replaced with additional                the docket for this notice and guidance.              markings, misleading advertising, and failure to
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                                                belt-wearable 1-hour SRLDs since there                     12 Id.
                                                                                                                                                              maintain or cause to be maintained the quality
                                                are currently no available Cap 3 CCERs                     13 See NIOSH National Personal Protective
                                                                                                                                                              control requirements of the certificate of
                                                that are belt or person-wearable.                       Technology Laboratory Certified Equipment List,       approval.’’). See also 42 CFR 84.43(c), which states
                                                                                                        https://www2a.cdc.gov/drds/cel/cel_form_code.asp.     that ‘‘[t]he Institute reserves the right to revoke, for
                                                                                                           14 Allen Dupree, Contura Energy, letter to         cause, any certificate of approval where it is found
                                                  7 30 CFR 75.1714(a), 75.1714–4.                       Maryann D’Alessandro, November 23, 2016,              that the applicant’s quality control test methods,
                                                  8 30 CFR 75.1714–2(b).                                Subject: Concerns regarding SCSR Rule. This letter    equipment, or records do not ensure effective
                                                  9 30 CFR 75.1714–1(a) and (b).
                                                                                                        is available in the docket for this notice and        quality control over the respirator for which the
                                                  10 Supra note 5.                                      guidance.                                             approval was issued.’’



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Document Created: 2016-12-28 02:16:52
Document Modified: 2016-12-28 02:16:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesNIOSH 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.
ContactMaryann 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]
FR Citation81 FR 95623 

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