[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Proposed Rules]
[Pages 53835-53839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22494]



42 CFR Part 84

[Docket No. CDC-2018-0068; NIOSH-318]
RIN 0920-AA67

Removal of Compliance Deadline for Closed-Circuit Escape 

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.


SUMMARY: With this deregulatory action, the Department of Health and 
Human Services (HHS) proposes to revise regulatory language which 
establishes a deadline by which respirator manufacturers must 
discontinue the manufacturing, labeling, and sale of certain self-
contained self-rescuer models. The National Institute for Occupational 
Safety and Health (NIOSH) within the Centers for Disease Control and 
Prevention, HHS, has determined that discontinuing the manufacturing, 
labeling, and sale of certain self-contained self-rescuer models is 
likely to result in a shortage of person-wearable large capacity escape 
respirators for underground coal miners who rely on these devices.

DATES: Comments must be received by November 26, 2018.

    Written comments: You may submit comments by any of the following 
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments to the docket.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2018-0068; NIOSH-318) or Regulation Identifier Number (0920-AA67) 
for this rulemaking. All relevant comments, including any personal 
information provided, will be posted without change to http://www.regulations.gov. For detailed instructions on submitting public 
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Office of the Director, 
NIOSH; 1090 Tusculum Avenue, MS:C-48, Cincinnati, OH 45226; telephone 
(855) 818-1629 (this is a toll-free number); email [email protected].


I. Public Participation

    Interested parties may participate in this rulemaking by submitting 
written views, opinions, recommendations, and data. Comments received, 
including attachments and other supporting materials, are part of the 
public record and subject to public disclosure. Do not include any 
information in your comment or supporting materials that you do not 
wish to be disclosed. You may submit comments on any topic related to 
this notice of proposed rulemaking.

II. Statutory Authority

    Pursuant to the Occupational Safety and Health (OSH) Act of 1970 
(Pub. L.

[[Page 53836]]

91-596), the Organic Act of 1910 (Pub. L. 179), and the Federal Mine 
Safety and Health Act of 1977 (30 U.S.C. 842(h), 844, 957; Pub. L. 91-
173), NIOSH is authorized to approve respiratory equipment used in 
mines and other workplaces for the protection of employees potentially 
exposed to hazardous breathing atmospheres. The Department of Labor's 
Mine Safety and Health Administration (MSHA) requires U.S. coal mine 
operators to supply NIOSH-approved respirators to miners whenever the 
use of respirators is required.

III. Background

    The closed-circuit escape respirator (CCER), one of two types of 
respirator considered ``self-contained breathing apparatus,'' is known 
in the mining industry as a ``self-contained self-rescuer'' (SCSR). In 
order to distinguish closed-circuit devices approved under 42 CFR part 
84, subpart H from those approved under subpart O, the former will be 
identified here as SCSRs and the latter will be identified as CCERs. 
The SCSR approved under subpart H and CCER approved under subpart O 
reflect two generations of the same respirator type 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 and CCER are used by miners and other workers to 
escape dangerous atmospheres.
    Technical requirements for the approval of CCERs were promulgated 
in a final rule published March 8, 2012, in which HHS codified the new 
subpart O, intended to eventually take the place of older requirements 
in 42 CFR part 84, subpart H that were applicable to the SCSR closed-
circuit escape respirators.\1\ The purpose of these updated 
requirements is to enable NIOSH and MSHA to more effectively ensure the 
performance, reliability, and safety of escape respirators used in 
underground coal mining and in other workplaces, such as the maritime 
industry, where these devices are used. 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 check subpart H-approved SCSRs for internal damage and 
the damage sustained to such devices in harsh underground environments. 
Furthermore, incidents in which users did not receive the expected 
duration of breathing air were common. The subpart H performance rating 
system classifies SCSRs by the duration of breathing air, and is widely 
known to create confusion among users because performance duration is 
highly variable, dependent on a variety of factors such as breathing 
rate and physiology of the user which can result in less protection 
time than the wearer expects. The need for the rulemaking was discussed 
in greater detail in the March 2012 final rule; background documents, 
including public comments, are available in NIOSH Docket 005.

    \1\ 77 FR 14168.

    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'' unit 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.\2\ CCERs of any capacity used 
in mining are still required to pass the subpart H ``Man Test 4.'' \3\ 
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.

    \2\ See Metzler R, Rehak T, Szalajda J, Berry Ann R, 
Understanding the Breathing Gas Capacities (Rating) of Escape 
Respirators for Mineworker Use, DHHS (NIOSH) Publication No. 2013-
148, May 2013, https://www.cdc.gov/niosh/docs/2013-148/pdfs/2013-148.pdf.
    \3\ See NIOSH National Personal Protective Technology 
Laboratory, Standard Testing Procedure (STP) to Conduct Man Test 4 
for Closed-Circuit Escape Respirators (CCERs) to be Used in 
Underground Coal Mines, https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-CCER-STP-0615-508.pdf.

    Because NIOSH determined that the resulting advances in CCER 
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 this 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 technical requirements to 1 year after the date that the 
first approval was granted to certain CCER models.\4\ 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, sell, and label 1-hour Subpart H-
approved SCSRs until January 4, 2017. The manufacturing, sale, or 
labeling 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; however, MSHA has recently 
expressed concern that a market gap is imminent in the underground coal 
mining industry.\5\

    \4\ The regulatory text, promulgated at 42 CFR 84.301(a), reads: 
``The 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.'' See 80 FR 48268.
    \5\ Joe Main, Assistant Secretary of Labor, MSHA, letter to John 
Howard, Director, NIOSH, December 14, 2016. This letter is available 
in NIOSH docket 285.

    In November 2016, the NIOSH National Personal Protective Technology 
Laboratory had a series of communications with representatives from 
MSHA, the underground coal mine industry, and two respirator 
manufacturers concerning the current supply of person-wearable escape 
respirators. 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 

    \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 53837]]

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 effectively person-wearable.\10\ Ocenco offers an 
approved Cap 1 mining CCER which is person-wearable, but provides 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).
    \10\ Although the CSE respirator, the SR2000, is designed to be 
person-wearable, MSHA has asserted that the size and weight prevent 
them from being worn in underground coal mines.

    According to MSHA,\11\ 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 a subpart H-
approved, 1-hour device called the ``SRLD,'' the only 1-hour, belt-
wearable escape respirator currently available on the market, 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 was expected to reach the end of its 
service life in 2017 and 2018. According to MSHA, these would need to 
be replaced with additional belt-wearable 1-hour SRLDs since the Cap 3 
CCERs approved by NIOSH that are belt or person-wearable are heavier 
and bulkier than their subpart H counterparts. Accordingly, MSHA asked 
that NIOSH extend the deadline.

    \11\ Supra note 5.

    In a letter to the NIOSH National Personal Protective Technology 
Laboratory, CSE Corporation, manufacturer of the 1-hour belt-wearable 
SCSR model named ``SRLD,'' reported similar concerns among its mining 
industry customers.\12\ 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 planned to be in full production in May 
2017. CSE informed NIOSH that it had a backlog of orders for subpart H 
SCSRs, which it was unable to fill before the January 4, 2017 
manufacturing deadline.

    \12\ Scott Shearer, CSE Corporation, letter to Maryann 
D'Alessandro, Director, NIOSH National Personal Protective 
Technology Laboratory, Subject: Cap 3 Closed-Circuit Escape 
Respirators Transition Plan, November 4, 2016. This letter is 
available in NIOSH docket 285.
    \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 NIOSH 
National Personal Protective Technology Laboratory to register similar 
concern about the availability of the 60-minute belt-wearable CSE model 

    \14\ Allen Dupree, Contura Energy, letter to Maryann 
D'Alessandro, November 23, 2016, Subject: Concerns regarding SCSR 
Rule. This letter is available in NIOSH docket 285.

    In response to the requests from MSHA, the mine industry, and 
respirator manufacturers, NIOSH announced an interim guidance document 
and requested public comment in a Federal Register document published 
on December 28, 2016.\15\ In a final guidance document published on 
April 14, 2017, NIOSH announced our intent not to revoke any 
certificate of approval for 1-hour escape respirators, approved under 
subpart H, that are manufactured, labeled, or sold prior to June 1, 
2019, provided that no cause for revocation exists under NIOSH 

    \15\ 81 FR 95623.
    \16\ 82 FR 18002.

    Since the publication of the guidance document, no new CCER 
approvals have been issued by the NIOSH National Personal Protective 
Technology Laboratory. Accordingly, NIOSH has determined that removing 
further restrictions on manufacturers' abilities to manufacture, label, 
or sell subpart H SCSRs is necessary for the safety of underground coal 
miners who rely on these devices. Therefore, HHS proposes to allow the 
continued manufacturing, labeling, and sale of subpart H SCSRs with 
current certificates of approval, indefinitely. No new approvals under 
subpart H will be issued.

IV. Summary of Proposed Rule

    In order to remove administrative barriers to an adequate market 
supply of SCSRs and CCERs, HHS proposes to make revisions to part 84, 
including revising Sec. Sec.  84.70 and 84.301. Section 84.70 would be 
revised by removing paragraph (a), which was added in 2012 to limit the 
scope of subpart H to open-circuit escape respirators and those closed-
circuit escape respirators approved under subpart H. Removing this 
paragraph will alleviate any confusion about the applicability of 
subpart H. The remainder of the section would be unchanged but for the 
remaining paragraphs being redesignated (a) through (d).
    Paragraph Sec.  84.301(c) would be redesignated as paragraph (a) 
and revised to state plainly that any CCER approvals issued after April 
9, 2012, the original effective date for the subpart O standards, must 
comply with the technical requirements of subpart O. Paragraph Sec.  
84.301(a) would be redesignated as paragraph (b) and would be revised 
to indicate that the manufacturing, labeling, and sale of SCSRs already 
holding a subpart H approval for units intended to be used in mining 
may continue indefinitely. Finally, paragraph Sec.  84.301(b) would be 
redesignated as paragraph (c) and revised to strike the word 
``former,'' to indicate that the subpart H technical requirements would 
still be used for maintenance of subpart H approvals. The paragraph 
would continue to state that major modifications to a design approved 
under subpart H must meet the technical requirements of subpart O and 
be issued a new approval accordingly.

[[Page 53838]]

V. Regulatory Assessment Requirements

A. Executive Order 12866 (Regulatory Planning and Review) and Executive 
Order 13563 (Improving Regulation and Regulatory Review)

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This proposed rule has been determined not to be a ``significant 
regulatory action'' under section 3(f) of E.O. 12866. The revision 
proposed in this notice would allow respirator manufacturers to 
continue the indefinite manufacturing, labeling, and sale of SCSRs 
approved under subpart H of 42 CFR part 84 and co-approved by MSHA 
pursuant to 30 CFR 75.1714-1. In accordance with current NIOSH 
guidance, manufacturers are currently expected to discontinue the 
manufacturing, labeling, and sale of subpart H SCSRs after June 2019.
    Because this proposed rule is intended to remove a restriction on 
the future sale of subpart H SCSRs, HHS expects that manufacturers 
holding approvals under subpart H will continue making and selling 
these devices without the uncertainty caused by the sunset clause in 42 
CFR 84.301 and the NIOSH guidance document. Manufacturers will not be 
forced to stop making and selling previously approved subpart H 
devices, nor will they need to develop new respirators under subpart O. 
Mine operators will be able to choose between purchasing subpart H 
devices, some of which are belt-wearable, and subpart O devices, some 
of which are also belt-wearable but may be larger, heavier, and more 
    This deregulatory action will not impose costs on either 
manufacturers or mine operators. Accordingly, HHS has not prepared an 
economic analysis and the Office of Management and Budget (OMB) has not 
reviewed this rulemaking.

B. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)

    Executive Order 13771 requires executive departments and agencies 
to eliminate at least two existing regulations for every new 
significant regulation that imposes costs. HHS has determined that this 
rulemaking is cost-neutral because it does not require any new action 
by stakeholders. The rulemaking ensures that mine operators who rely on 
subpart H respirators can continue to purchase them as needed, which is 
likely to be more economical than switching to the subpart O devices. 
Because OMB has determined that this rulemaking is not significant, 
pursuant to E.O. 12866, and because it is both a deregulatory action 
and does not impose costs, OMB has determined that this rulemaking is 
exempt from the requirements of E.O. 13771. Thus it has not been 
reviewed by OMB.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. HHS 
certifies that this proposed rule has ``no significant economic impact 
upon a substantial number of small entities'' within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

D. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on, and to obtain OMB approval of, 
any regulation that requires 10 or more people to report information to 
the agency or to keep certain records. In accordance with section 
3507(d) of the PRA, HHS has determined that the Paperwork Reduction Act 
does apply to information collection and recordkeeping requirements 
included in this rulemaking. The Office of Management and Budget (OMB) 
has already approved the information collection and recordkeeping 
requirements under OMB Control Number 0920-0109, Information Collection 
Provisions in 42 CFR part 84--Tests and Requirements for Certification 
and Approval of Respiratory Protective Devices (expiration date 4/30/
2021). The proposed amendments in this rulemaking would not impact the 
collection of data.

E. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 

F. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local, or Tribal governments in the 
aggregate, or by the private sector.

G. Executive Order 12988 (Civil Justice Reform)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988 and will not unduly burden the Federal court 
system. This rule has been reviewed carefully to eliminate drafting 
errors and ambiguities.

H. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule would not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

I. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this proposed rule on 
children. HHS has determined that the rule would have no environmental 
health and safety effect on children.

J. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution or use, 
and has determined that the rule would not have a significant adverse 

K. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to

[[Page 53839]]

the public how to comply with a requirement the Federal government 
administers or enforces. HHS has attempted to use plain language in 
promulgating the proposed rule consistent with the Federal Plain 
Writing Act guidelines.

List of Subjects in 42 CFR Part 84

    Mine safety and health, Occupational safety and health, Personal 
protective equipment, Respirators.

Proposed Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR 84.70 and 84.301 as 


1. The authority citation for part 84 continues to read as follows:

     Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3, 5, 7, 811, 
842(h), 844.

Sec.  84.70  [Amended]

2. Amend Sec.  84.70 by removing paragraph (a) and redesignating 
paragraphs (b) through (e) as (a) through (d).
3. Revise Sec.  84.301 to read as follows:

Sec.  84.301  Applicability to new and previously approved CCERs.

    (a) Any CCER approval issued after April 9, 2012 must comply with 
the technical requirements of subpart O.
    (b) The continued manufacturing, labeling, and sale of closed-
circuit apparatus previously approved under subpart H is authorized for 
units required for use in underground coal mines pursuant to 30 CFR 
    (c) Any manufacturer-requested modification to a device approved 
under the subpart H technical requirements must comply with the subpart 
H technical requirements and address an identified worker safety or 
health concern to be granted an extension of the NIOSH approval. Major 
modifications to the configuration that will result in a new approval 
must meet and be issued approvals under the requirements of this 
subpart O.

    Dated: October 9, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-22494 Filed 10-24-18; 8:45 am]