[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC-2018-0068; NIOSH-318]
RIN 0920-AA67
Removal of Compliance Deadline for Closed-Circuit Escape
Respirators
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Notice of proposed rulemaking.
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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.
ADDRESSES:
Written comments: You may submit comments by any of the following
methods:
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].
SUPPLEMENTARY INFORMATION:
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.
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\1\ 77 FR 14168.
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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'' 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.
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\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.
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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\
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\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.
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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
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 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.
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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).
\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.
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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.
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\11\ Supra note 5.
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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.
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\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.
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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
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 NIOSH docket 285.
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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
regulations.\16\
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\15\ 81 FR 95623.
\16\ 82 FR 18002.
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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
expensive.
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
date.
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
effect.
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
follows:
PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
0
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]
0
2. Amend Sec. 84.70 by removing paragraph (a) and redesignating
paragraphs (b) through (e) as (a) through (d).
0
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
75.1714-1.
(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]
BILLING CODE 4163-19-P