Closed-Circuit Escape Respirators; Extension of Transition Period, 4801-4805 [2015-01057]
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations
State citation
State
effective
date
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Explanations
74:09:01 Contested Case Procedure
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Board member conflict of interest
5/29/2014
74:09:01:21 ..................................
Board member potential conflicts
of interests.
5/29/2014
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1/29/2015, [insert Federal Register citation].
1/29/2015, [insert Federal Register citation].
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74:36:09 Prevention of Significant Deterioration
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Prevention of significant deterioration.
Public participation ......................
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6/25/2013
6/25/2013
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1/29/2015, [insert Federal Register citation].
1/29/2015, [insert Federal Register citation].
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1 In
order to determine the EPA effective date for a specific provision that is listed in this table, consult the Federal Register cited in this column for that particular provision.
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Name of nonregulatory
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area
State submittal date/
adopted date
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XIV. Section 110(a)(2)
Infrastructure Requirements for the
1997 and 2006
PM2.5 NAAQS.
XV. Section 110(a)(2)
Infrastructure Requirements for the
2008 Lead NAAQS.
XVI. Section 110(a)(2)
Infrastructure Requirements for the
2008 8-hour Ozone
NAAQS.
XVII. Section 110(a)(2)
Infrastructure Requirements for the
2010 NO2 NAAQS.
XVIII. SDCL (South
Dakota Codified
Laws), 1–40–25.1.
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Statewide ...................
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Submitted: 5/20/2008
1/29/2015, [insert
and 03/04/2011.
Federal Register
citation].
Statewide ...................
Submitted: 10/10/2012
1/29/2015, [insert
Federal Register
citation].
Statewide ...................
Submitted: 5/21/13 ....
1/29/2015, [insert
Federal Register
citation].
Statewide ...................
Submitted: 10/23/13 ..
1/29/2015, [insert
Federal Register
citation].
Statewide ...................
Submitted: 6/11/2014
1/29/2015, [insert
Federal Register
citation].
EPA approval date
and citation 5
Explanations
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*
Excluding 110(D)(i)(I), interstate transport for
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acted on separately.
Source: SL 1995, ch 318 (Ex. Ord. 95–2),
§ 15.
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[FR Doc. 2015–01613 Filed 1–28–15; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 84
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[Docket Number CDC–2015–0004; NIOSH–
280]
RIN 0920–AA60
Closed-Circuit Escape Respirators;
Extension of Transition Period
Centers for Disease Control and
Prevention, HHS.
AGENCY:
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ACTION:
Interim final rule.
In March 2012, the
Department of Health and Human
Services (HHS) published a final rule
establishing new standards for the
certification of closed-circuit escape
respirators (CCERs) by the National
Institute for Occupational Safety and
Health (NIOSH) within the Centers for
Disease Control and Prevention (CDC).
The new standards were designed to
take effect over a 3-year transition
period. HHS has determined that
SUMMARY:
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extending the concluding date for the
transition is necessary to allow
sufficient time for respirator
manufacturers to meet the demands of
the mining, maritime, railroad, and
other industries. Pursuant to this
interim final rule, NIOSH will extend
the phase-in period until 6 months after
the date that the first approval is granted
to certain CCER models.
DATES: This rule is effective on January
29, 2015. Comments must be received
by March 30, 2015.
ADDRESSES: You may submit comments,
identified by ‘‘RIN 0920–AA60,’’ by any
of the following methods:
• Internet: Access the Federal erulemaking portal at https://
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 or Regulation Identifier
Number (RIN) for this rulemaking. All
relevant comments will be posted
without change to https://
www.regulations.gov including any
personal information provided. For
detailed instructions on submitting
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst; 1090
Tusculum Ave., MS: C–46, Cincinnati,
OH 45226; telephone (855) 818–1629
(this is a toll-free number); email
NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
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Table of Contents
I. Public Participation
II. Background
A. History of Rulemaking
B. Need for Rulemaking
C. Scope
III. Issuance of an Interim Final Rule With
Immediate Effective Date
IV. Summary of Interim Final Rule
V. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement
Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
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I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
J. Plain Writing Act of 2010
Interim Final Rule
I. Public Participation
Interested persons or organizations
are invited to participate in this
rulemaking by submitting written views,
arguments, recommendations, and data.
Comments are invited on any topic
related to this rulemaking. HHS invites
comments specifically on the following
question related to this rulemaking:
1. Will a compliance date 6 months
after the date that the first approval is
granted in each of three categories of
CCER types provide sufficient time for
respirator manufacturers to develop
production capacity to meet expected
market demand, while not causing
undue loss of sales revenue that may be
expected from achieving the first
successful design for the given size?
II. Background
A. History of Rulemaking
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. The Mine Safety and
Health Administration (MSHA) and the
Occupational Safety and Health
Administration (OSHA) require U.S.
employers to supply NIOSH-approved
respirators to their employees whenever
the employer requires the use of
respirators.
A closed-circuit escape respirator
(CCER) is an apparatus in which the
wearer’s exhalation is rebreathed after
the carbon dioxide in the exhaled breath
has been effectively removed and a
suitable oxygen supply has been
restored from sources composed of
compressed, chemical, or liquid oxygen.
CCERs are 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 CCER,
known in the mining industry as a selfcontained self-rescuer, is used by
miners to escape dangerous
atmospheres in mines. It is also used by
certain Navy and Coast Guard
personnel, such as crews working below
decks on vessels, where it is referred to
as an emergency escape breathing
device, and in the railroad industry,
where it is known as an emergency
escape breathing apparatus. To a lesser
extent, it is also used by other workers
who work underground or in confined
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spaces, such as in tunneling operations
in the construction industry.
Standards for the certification of
CCERs were updated in a 2012 final
rule, 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. 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.
The effective date for the new
standards in Subpart O was April 9,
2012. Beginning on that date, any new
application for a certification of
approval for a CCER would be required
to meet the new standards in Subpart O.
Manufacturers were allowed to continue
to manufacture, label, and sell
respirators certified to the prior Subpart
H standard until April 9, 2015.
B. Need for Rulemaking
HHS has determined that extending
the concluding date for the transition is
necessary to allow sufficient time for
respirator manufacturers to meet the
demands of the mining, maritime,
railroad, and other industries. NIOSH
has found that respirator manufacturers
that have submitted applications under
the Subpart O standards have not been
successful in meeting those standards
and obtaining approval of any largecapacity CCERs. While one
manufacturer recently received NIOSH
approval for a small-capacity nonmining respirator, large-capacity units
designed for underground coal mining
and other industries are not likely to
receive NIOSH approval before the
April 9, 2015 deadline. Mining industry
and maritime stakeholders have
expressed concern that an adequate
number of new CCERs will not be
available for purchase by April 2015,
when the grandfather clause is set to
expire, leaving miners, sailors, and
other workers with insufficient
protection.
C. Scope
Pursuant to this interim final rule,
which amends 42 CFR 84.301, NIOSH
will extend the deadline for Subpart O
compliance until 6 months after the date
on which NIOSH approves the first
CCER in each of the following three
categories, described in 42 CFR 84.304:
Cap 1 mining, Cap 3 mining, and Cap
3 non-mining.
CCER Cap 1 non-mining and Cap 2
mining and non-mining categories are
not included in this rulemaking.
Approval TC–13G–0001 was issued to
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Avon Protection Systems, Inc. on July
24, 2014 for its ER–2 emergency escape
breathing device (EEBD). The ER–2
EEBD is certified by NIOSH as a Cap 1,
20-liter, CCER for use in non-mining
applications. The current deadline for
compliance (April 9, 2015) already
provides for more than a 6-month
period for the issuance of additional
approvals for respirators in this
category. Therefore, NIOSH has
determined no further extension of the
existing April 9, 2015 deadline is
required for the Cap 1 non-mining
category. The Cap 2 mining and nonmining categories are not included in
this rulemaking because NIOSH never
approved any respirators under the
former Subpart H requirements that
would be classified within either of
these two categories.
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III. Issuance of an Interim Final Rule
With Immediate Effective Date
Rulemaking under the Administrative
Procedure Act (APA) generally requires
a public notice and comment period and
consideration of the submitted
comments prior to promulgation of a
final rule (5 U.S.C. 553). However, the
APA provides for exceptions to its
notice and comment procedures when
an agency finds that there is good cause
for dispensing with such procedures on
the basis that they are impracticable,
unnecessary, or contrary to the public
interest. In accordance with the
provisions in 5 U.S.C. 553(b)(3)(B), HHS
finds good cause to waive the use of
prior notice and comment procedures
for this IFR and to make this action
effective immediately.
This IFR amends 42 CFR 84.301 to
extend the concluding date for the
Subpart O transition to allow sufficient
time for respirator manufacturers to
meet the supply demands of the mining,
maritime, railroad, and other industries.
Pursuant to this interim final rule,
NIOSH will extend the deadline for
Subpart O compliance until 6 months
after the date on which NIOSH approves
the first CCER in each of three
categories. HHS has determined that it
is impracticable to use prior notice and
comment procedures for this IFR
because the transition period will end
on April 9, 2015, and respirator
manufacturers must have sufficient
notice that they may be granted an
extension. Thus, HHS is waiving the
prior notice and comment procedures in
the interest of protecting the health of
coal miners and workers in other
industries that use CCERs by offering
extensions to manufacturers to ensure
that the supply of new CCERs will not
be depleted after April 9, 2015.
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Stakeholders were given an
opportunity to comment on the CCER
notice of proposed rulemaking,
published on December 10, 2008 (73 FR
75027), in which HHS proposed that all
CCERs submitted to NIOSH for approval
on or after the effective date would
adhere to the new standards; all CCERs
sold after 3 years would adhere to the
new standards; and all certificates of
approval under the former standard
would be rescinded at 6 years. In
response to stakeholder comments, HHS
determined that the products certified
under the former standard could remain
in service through the service time
indicated by the manufacturer
(typically, 10–15 years), rather than
those approvals being rescinded at 6
years, and that retaining the 3-year
transition period would address the
needs of workplace managers to have a
sufficient supply of CCERs while
ostensibly giving respirator
manufacturers sufficient time to develop
new products in accordance with the
new standards. With the April 9, 2015
deadline approaching, manufacturers
and other stakeholders have expressed
concerns that no new products certified
to the Subpart O requirements have yet
become available. During a NIOSH
status update at a MSHA meeting held
on June 19, 2014, participating
stakeholders were given an additional
opportunity to provide input to NIOSH
and MSHA, where they expressed
concern about the manufacturers’
inability to submit respirators to NIOSH
for approval prior to the concluding
date of the transition period. A majority
of manufacturers who have offered
input to NIOSH indicate that they will
not be able to build enough capacity of
units submitted under Subpart O to
meet market demands prior to the April
9, 2015 deadline.
Under 5 U.S.C. 553(d)(3), HHS finds
good cause to make this IFR effective
immediately. As stated above, in order
to protect the health of coal miners and
workers in other industries, it is
necessary that HHS act quickly to
amend 42 CFR 84.301 to allow NIOSH
to offer transition period concluding
date extensions on a case-by-case basis.
While amendments to 42 CFR 84.301
are effective on the date of publication
of this IFR, they are interim and will be
finalized following the receipt and
consideration of any substantive public
comments. (See Section I. Public
Participation, above.)
IV. Summary of Interim Final Rule
This interim final rule amends 42 CFR
84.301 to allow NIOSH to extend the
original 3-year period for continued
manufacturing, labeling, and sale of
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4803
CCERs approved under Subpart H to
allow for the orderly implementation of
the new testing and certification
requirements of Subpart O. This
provision allows NIOSH to extend the
original transition period to allow
manufacturers to obtain NIOSH
certification, establish production
capacity, and complete the modification
of existing CCER designs, if necessary,
or develop entirely new designs that
respond to the new testing and
certification requirements. An extension
also ensures that a constant supply of
approved CCERs will remain available
for purchase. The new Subpart O
standards will continue to be applied to
all new CCER designs that are submitted
for approval.
Paragraph (a) of this section is new,
and authorizes the continued
manufacturing, labeling, and selling of
CCERs approved under the former
standards in Subpart H until either
April 9, 2015 or 6 months after the date
that NIOSH first approves a CCER
model under the capacity rating
categories Cap 1 (for mining
applications) and Cap 3 (mining and
non-mining) described in 42 CFR
84.304, whichever date comes later. In
particular, the compliance deadline may
be extended for only those types of
CCER that are currently approved under
the former standards in Subpart H: 20minute non-mining units and 10-minute
and 1-hour units approved for mining
pursuant to 42 CFR 84.100. As
discussed in the final rule published on
March 8, 2012, 10-minute units are
considered comparable to Cap 1
devices, and 1-hour units are
comparable to Cap 3 devices (77 FR
14168).
A new paragraph (b) clarifies that any
non-major modifications to those
approved devices must continue to meet
the prior Subpart H standards. CCERs
with major modifications that will result
in a new NIOSH approval must conform
to the new Subpart O standards.
Paragraph (c) of this section is
unchanged from the current
requirement that Subpart O applies to
all CCERs submitted to NIOSH for
approval after the effective date of the
final rule, April 9, 2012.
V. Regulatory Assessment
Requirements
A. Executive Order 12866 and Executive
Order 13563
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
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(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 interim final rule is not being
treated as a ‘‘significant’’ action under
E.O. 12866. It amends existing 42 CFR
84.301 to allow NIOSH to extend the
deadline for respirator certification
standards established in 2012, and does
not result in any costs to affected
stakeholders. Accordingly, HHS has not
prepared an economic analysis and the
Office of Management and Budget
(OMB) has not reviewed this
rulemaking.
The rule does not interfere with State,
local, or tribal governments in the
exercise of their governmental
functions.
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B. 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-forprofit organizations. The Department of
Health and Human Services (HHS)
certifies that this interim final rule will
not have a significant economic impact
on a substantial number of small
entities, including both small
manufacturers of CCERs and the small
mining operators that are required to
purchase them, within the meaning of
the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44
U.S.C. 3501 et seq., requires an agency
to invite public comment on and to
obtain OMB approval of any rule of
general applicability that requires
recordkeeping, reporting, or disclosure
requirements.
NIOSH has obtained approval from
OMB to collect information from
respirator manufacturers under
‘‘Information Collection Provisions in
42 CFR Part 84—Tests and
Requirements for Certification and
Approval of Respiratory Protective
Devices’’ (OMB Control No. 0920–0109,
exp. November 30, 2017), which covers
information collected under 42 CFR part
84. This rulemaking does not increase
the reporting burden on respirator
manufacturers.
D. Small Business Regulatory
Enforcement Fairness Act
As required by Congress under the
Small Business Regulatory Enforcement
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Fairness Act of 1996 (5 U.S.C. 801 et
seq.), the Department will report the
promulgation of this rule to Congress
prior to its effective date. The report
will state that the Department has
concluded that this rule is not a ‘‘major
rule’’ because it is not likely to result in
an annual effect on the economy of $100
million or more.
E. Unfunded Mandates Reform Act of
1995
I. 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 rule on energy supply, distribution
or use, and has determined that the rule
will not have a significant adverse
effect.
J. Plain Writing Act of 2010
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 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. For 2014, the
inflation-adjusted threshold is $152
million.
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal Government
administers or enforces. HHS has
attempted to use plain language in
promulgating the interim final rule
consistent with the Federal Plain
Writing Act guidelines.
F. Executive Order 12988 (Civil Justice)
For the reasons discussed in the
preamble, the Department of Health and
Human Services amends 42 CFR part 84
as follows:
This rule has been drafted and
reviewed in accordance with Executive
Order 12988, ‘‘Civil Justice Reform,’’
and will not unduly burden the Federal
court system. NIOSH has provided clear
deadline extension requirements that
will be applied uniformly to all
applications from manufacturers of
CCERs. This rule has been reviewed
carefully to eliminate drafting errors and
ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this
rule in accordance with Executive Order
13132 regarding federalism, and has
determined that it does not have
‘‘federalism implications.’’ The rule
does 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.’’
H. 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 rule on children. HHS has
determined that the rule would have no
effect on children.
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List of Subjects in 42 CFR Part 84
Incorporation by reference, Mine
safety and health, Occupational safety
and health, Personal protective
equipment, Respirators.
Interim Final Rule
PART 84—APPROVAL OF
RESPIRATORY PROTECTIVE DEVICES
1. The authority citation for Part 84 is
revised to read as follows:
■
Authority: 29 U.S.C. 651 et seq., 30 U.S.C.
3, 5, 7, 811, 842(h), 844.
■
2. Revise § 84.301 to read as follows:
§ 84.301 Applicability to new and
previously approved CCERs.
(a) The continued manufacturing,
labeling, and sale of CCERs previously
approved under Subpart H is authorized
for units with durations comparable to
Cap 1 (for mining applications) and Cap
3 (mining and non-mining applications)
until either April 9, 2015 or 6 months
after the date of the first NIOSH
approval of a respirator model under
each respective category specified,
whichever date comes later.
(b) Any manufacturer-requested
modification to a device approved
under the former subpart H standards
must comply with the former subpart H
standards 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 number must meet and be
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issued approvals under the
requirements of this subpart O.
(c) This subpart O applies to all
CCERs submitted to NIOSH for a
certificate of approval after April 9,
2012.
Ms.
Amy G. Williams, telephone 571–372–
6106.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Dated: January 14, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2015–01057 Filed 1–28–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC–2013–0004; NIOSH–216]
RIN 0920–AA42
Respirator Certification Fees
Correction
In rule document 2015–01046,
appearing on pages 3891–3913 in the
issue of Monday, January 26, 2015,
make the following correction:
On page 3894, in the second column,
in the third paragraph, the entry reading
‘‘[INSERT DATE 120 DAYS AFTER
PUBLICATION IN THE Federal
Register]’’ should read May 26, 2015.
[FR Doc. C1–2015–01046 Filed 1–28–15; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 225
RIN 0750–AI49
Defense Federal Acquisition
Regulation Supplement: Updated
Descriptions of Product Service
Groups Subject to Trade Agreements
(DFARS Case 2015–D004)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
AGENCY:
DoD is issuing a final rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to update the descriptions of
Federal supply groups (now identified
as product service groups) subject to
trade agreements to conform to the
current Federal Procurement Data
System Product and Service Codes
Manual.
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SUMMARY:
DATES:
Effective January 29, 2015.
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I. Background
This final rule amends DFARS
225.401–70 to update the descriptions
of the Federal supply groups, now
identified as product service groups
(PSGs), to conform to the Federal
Procurement Data System Product and
Service Codes Manual, August 2011
Edition. DFARS 225.401–70 lists end
products that are subject to trade
agreements when acquired by DoD.
There are no changes to the groups
covered; however, a number of the PSG
descriptions are updated in order to
better reflect product coverage. The
World Trade Organization Government
Procurement Agreement, Free Trade
Agreement, and other designated
countries will continue to have
guaranteed access to the goods
committed under U.S. international
agreements. The revised descriptions
more clearly include some new items
that were not previously mentioned in
the descriptions, even though included
in the product service group.
II. Publication of This Final Rule for
Public Comment Is Not Required by
Statute
‘‘Publication of proposed
regulations’’, 41 U.S.C. 1707, is the
statute which applies to the publication
of the Federal Acquisition Regulation.
Paragraph (a)(1) of the statute requires
that a procurement policy, regulation,
procedure or form (including an
amendment or modification thereof)
must be published for public comment
if it relates to the expenditure of
appropriated funds, and has either a
significant effect beyond the internal
operating procedures of the agency
issuing the policy, regulation, procedure
or form, or has a significant cost or
administrative impact on contractors or
offerors. This final rule is not required
to be published for public comment,
because it does not change the Federal
supply groups covered, but just updates
the descriptions of the listed product
service groups to reflect the current
Product and Service Codes Manual. It
does not impact which products are
subject to trade agreements.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 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,
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
4805
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 is not a significant
regulatory action and, therefore, was not
subject to review under section 6(b) of
E.O. 12866, Regulatory Planning and
Review, dated September 30, 1993. This
rule is not a major rule under 5 U.S.C.
804.
IV. Regulatory Flexibility Act
The Regulatory Flexibility Act does
not apply to this rule because this final
rule does not constitute a significant
DFARS revision within the meaning of
FAR 1.501–1, and 41 U.S.C. 1707 does
not require publication for public
comment.
V. Paperwork Reduction Act
The rule does not contain any
information collection requirements that
require the approval of the Office of
Management and Budget under the
Paperwork Reduction Act (44 U.S.C.
chapter 35).
List of Subjects in 48 CFR Part 225
Government procurement.
Manuel Quinones,
Editor, Defense Acquisition Regulations
System.
Therefore, 48 CFR part 225 is
amended as follows:
PART 225—FOREIGN ACQUISITION
1. The authority citation for 48 CFR
part 225 continues to read as follows:
■
Authority: 41 U.S.C. 1303 and 48 CFR
chapter 1.
225.401–70
[Amended]
2. Amend section 225.401–70 by—
a. In the introductory text, removing
‘‘Federal supply groups (FSG)’’ and
adding ‘‘product service groups (PSGs)’’
in its place;
■ b. In the table column heading,
removing ‘‘FSG’’ and adding ‘‘PSG’’ in
its place;
■ c. In newly redesignated entry PSG 23,
removing ‘‘(except 2350 and buses
under 2310)’’ and adding ‘‘(except 2305,
2350, and buses under 2310)’’ in its
place;
■ d. In newly redesignated entry PSG
40, adding a comma after ‘‘chain’’;
■ e. In newly redesignated entry PSG 41,
removing ‘‘Refrigeration and air
conditioning equipment’’ and adding
‘‘Refrigeration, air conditioning, and air
circulating equipment’’ in its place;
■ f. In newly redesignated entry PSG 42,
removing ‘‘Fire fighting, rescue and
■
■
E:\FR\FM\29JAR1.SGM
29JAR1
]]>Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Rules and Regulations]
[Pages 4801-4805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01057]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
[Docket Number CDC-2015-0004; NIOSH-280]
RIN 0920-AA60
Closed-Circuit Escape Respirators; Extension of Transition Period
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Interim final rule.
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SUMMARY: In March 2012, the Department of Health and Human Services
(HHS) published a final rule establishing new standards for the
certification of closed-circuit escape respirators (CCERs) by the
National Institute for Occupational Safety and Health (NIOSH) within
the Centers for Disease Control and Prevention (CDC). The new standards
were designed to take effect over a 3-year transition period. HHS has
determined that
[[Page 4802]]
extending the concluding date for the transition is necessary to allow
sufficient time for respirator manufacturers to meet the demands of the
mining, maritime, railroad, and other industries. Pursuant to this
interim final rule, NIOSH will extend the phase-in period until 6
months after the date that the first approval is granted to certain
CCER models.
DATES: This rule is effective on January 29, 2015. Comments must be
received by March 30, 2015.
ADDRESSES: You may submit comments, identified by ``RIN 0920-AA60,'' by
any of the following methods:
Internet: Access the Federal e-rulemaking portal at https://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 or Regulation Identifier Number (RIN) for this
rulemaking. All relevant comments will be posted without change to
https://www.regulations.gov including any personal information provided.
For detailed instructions on submitting comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090
Tusculum Ave., MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629
(this is a toll-free number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Public Participation
II. Background
A. History of Rulemaking
B. Need for Rulemaking
C. Scope
III. Issuance of an Interim Final Rule With Immediate Effective Date
IV. Summary of Interim Final Rule
V. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
Interim Final Rule
I. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments are invited on any topic related to
this rulemaking. HHS invites comments specifically on the following
question related to this rulemaking:
1. Will a compliance date 6 months after the date that the first
approval is granted in each of three categories of CCER types provide
sufficient time for respirator manufacturers to develop production
capacity to meet expected market demand, while not causing undue loss
of sales revenue that may be expected from achieving the first
successful design for the given size?
II. Background
A. History of Rulemaking
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. The Mine
Safety and Health Administration (MSHA) and the Occupational Safety and
Health Administration (OSHA) require U.S. employers to supply NIOSH-
approved respirators to their employees whenever the employer requires
the use of respirators.
A closed-circuit escape respirator (CCER) is an apparatus in which
the wearer's exhalation is rebreathed after the carbon dioxide in the
exhaled breath has been effectively removed and a suitable oxygen
supply has been restored from sources composed of compressed, chemical,
or liquid oxygen. CCERs are 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 CCER, known
in the mining industry as a self-contained self-rescuer, is used by
miners to escape dangerous atmospheres in mines. It is also used by
certain Navy and Coast Guard personnel, such as crews working below
decks on vessels, where it is referred to as an emergency escape
breathing device, and in the railroad industry, where it is known as an
emergency escape breathing apparatus. To a lesser extent, it is also
used by other workers who work underground or in confined spaces, such
as in tunneling operations in the construction industry.
Standards for the certification of CCERs were updated in a 2012
final rule, 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. 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.
The effective date for the new standards in Subpart O was April 9,
2012. Beginning on that date, any new application for a certification
of approval for a CCER would be required to meet the new standards in
Subpart O. Manufacturers were allowed to continue to manufacture,
label, and sell respirators certified to the prior Subpart H standard
until April 9, 2015.
B. Need for Rulemaking
HHS has determined that extending the concluding date for the
transition is necessary to allow sufficient time for respirator
manufacturers to meet the demands of the mining, maritime, railroad,
and other industries. NIOSH has found that respirator manufacturers
that have submitted applications under the Subpart O standards have not
been successful in meeting those standards and obtaining approval of
any large-capacity CCERs. While one manufacturer recently received
NIOSH approval for a small-capacity non-mining respirator, large-
capacity units designed for underground coal mining and other
industries are not likely to receive NIOSH approval before the April 9,
2015 deadline. Mining industry and maritime stakeholders have expressed
concern that an adequate number of new CCERs will not be available for
purchase by April 2015, when the grandfather clause is set to expire,
leaving miners, sailors, and other workers with insufficient
protection.
C. Scope
Pursuant to this interim final rule, which amends 42 CFR 84.301,
NIOSH will extend the deadline for Subpart O compliance until 6 months
after the date on which NIOSH approves the first CCER in each of the
following three categories, described in 42 CFR 84.304: Cap 1 mining,
Cap 3 mining, and Cap 3 non-mining.
CCER Cap 1 non-mining and Cap 2 mining and non-mining categories
are not included in this rulemaking. Approval TC-13G-0001 was issued to
[[Page 4803]]
Avon Protection Systems, Inc. on July 24, 2014 for its ER-2 emergency
escape breathing device (EEBD). The ER-2 EEBD is certified by NIOSH as
a Cap 1, 20-liter, CCER for use in non-mining applications. The current
deadline for compliance (April 9, 2015) already provides for more than
a 6-month period for the issuance of additional approvals for
respirators in this category. Therefore, NIOSH has determined no
further extension of the existing April 9, 2015 deadline is required
for the Cap 1 non-mining category. The Cap 2 mining and non-mining
categories are not included in this rulemaking because NIOSH never
approved any respirators under the former Subpart H requirements that
would be classified within either of these two categories.
III. Issuance of an Interim Final Rule With Immediate Effective Date
Rulemaking under the Administrative Procedure Act (APA) generally
requires a public notice and comment period and consideration of the
submitted comments prior to promulgation of a final rule (5 U.S.C.
553). However, the APA provides for exceptions to its notice and
comment procedures when an agency finds that there is good cause for
dispensing with such procedures on the basis that they are
impracticable, unnecessary, or contrary to the public interest. In
accordance with the provisions in 5 U.S.C. 553(b)(3)(B), HHS finds good
cause to waive the use of prior notice and comment procedures for this
IFR and to make this action effective immediately.
This IFR amends 42 CFR 84.301 to extend the concluding date for the
Subpart O transition to allow sufficient time for respirator
manufacturers to meet the supply demands of the mining, maritime,
railroad, and other industries. Pursuant to this interim final rule,
NIOSH will extend the deadline for Subpart O compliance until 6 months
after the date on which NIOSH approves the first CCER in each of three
categories. HHS has determined that it is impracticable to use prior
notice and comment procedures for this IFR because the transition
period will end on April 9, 2015, and respirator manufacturers must
have sufficient notice that they may be granted an extension. Thus, HHS
is waiving the prior notice and comment procedures in the interest of
protecting the health of coal miners and workers in other industries
that use CCERs by offering extensions to manufacturers to ensure that
the supply of new CCERs will not be depleted after April 9, 2015.
Stakeholders were given an opportunity to comment on the CCER
notice of proposed rulemaking, published on December 10, 2008 (73 FR
75027), in which HHS proposed that all CCERs submitted to NIOSH for
approval on or after the effective date would adhere to the new
standards; all CCERs sold after 3 years would adhere to the new
standards; and all certificates of approval under the former standard
would be rescinded at 6 years. In response to stakeholder comments, HHS
determined that the products certified under the former standard could
remain in service through the service time indicated by the
manufacturer (typically, 10-15 years), rather than those approvals
being rescinded at 6 years, and that retaining the 3-year transition
period would address the needs of workplace managers to have a
sufficient supply of CCERs while ostensibly giving respirator
manufacturers sufficient time to develop new products in accordance
with the new standards. With the April 9, 2015 deadline approaching,
manufacturers and other stakeholders have expressed concerns that no
new products certified to the Subpart O requirements have yet become
available. During a NIOSH status update at a MSHA meeting held on June
19, 2014, participating stakeholders were given an additional
opportunity to provide input to NIOSH and MSHA, where they expressed
concern about the manufacturers' inability to submit respirators to
NIOSH for approval prior to the concluding date of the transition
period. A majority of manufacturers who have offered input to NIOSH
indicate that they will not be able to build enough capacity of units
submitted under Subpart O to meet market demands prior to the April 9,
2015 deadline.
Under 5 U.S.C. 553(d)(3), HHS finds good cause to make this IFR
effective immediately. As stated above, in order to protect the health
of coal miners and workers in other industries, it is necessary that
HHS act quickly to amend 42 CFR 84.301 to allow NIOSH to offer
transition period concluding date extensions on a case-by-case basis.
While amendments to 42 CFR 84.301 are effective on the date of
publication of this IFR, they are interim and will be finalized
following the receipt and consideration of any substantive public
comments. (See Section I. Public Participation, above.)
IV. Summary of Interim Final Rule
This interim final rule amends 42 CFR 84.301 to allow NIOSH to
extend the original 3-year period for continued manufacturing,
labeling, and sale of CCERs approved under Subpart H to allow for the
orderly implementation of the new testing and certification
requirements of Subpart O. This provision allows NIOSH to extend the
original transition period to allow manufacturers to obtain NIOSH
certification, establish production capacity, and complete the
modification of existing CCER designs, if necessary, or develop
entirely new designs that respond to the new testing and certification
requirements. An extension also ensures that a constant supply of
approved CCERs will remain available for purchase. The new Subpart O
standards will continue to be applied to all new CCER designs that are
submitted for approval.
Paragraph (a) of this section is new, and authorizes the continued
manufacturing, labeling, and selling of CCERs approved under the former
standards in Subpart H until either April 9, 2015 or 6 months after the
date that NIOSH first approves a CCER model under the capacity rating
categories Cap 1 (for mining applications) and Cap 3 (mining and non-
mining) described in 42 CFR 84.304, whichever date comes later. In
particular, the compliance deadline may be extended for only those
types of CCER that are currently approved under the former standards in
Subpart H: 20-minute non-mining units and 10-minute and 1-hour units
approved for mining pursuant to 42 CFR 84.100. As discussed in the
final rule published on March 8, 2012, 10-minute units are considered
comparable to Cap 1 devices, and 1-hour units are comparable to Cap 3
devices (77 FR 14168).
A new paragraph (b) clarifies that any non-major modifications to
those approved devices must continue to meet the prior Subpart H
standards. CCERs with major modifications that will result in a new
NIOSH approval must conform to the new Subpart O standards.
Paragraph (c) of this section is unchanged from the current
requirement that Subpart O applies to all CCERs submitted to NIOSH for
approval after the effective date of the final rule, April 9, 2012.
V. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
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
[[Page 4804]]
(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 interim final rule is not being treated as a ``significant''
action under E.O. 12866. It amends existing 42 CFR 84.301 to allow
NIOSH to extend the deadline for respirator certification standards
established in 2012, and does not result in any costs to affected
stakeholders. Accordingly, HHS has not prepared an economic analysis
and the Office of Management and Budget (OMB) has not reviewed this
rulemaking.
The rule does not interfere with State, local, or tribal
governments in the exercise of their governmental functions.
B. 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. The
Department of Health and Human Services (HHS) certifies that this
interim final rule will not have a significant economic impact on a
substantial number of small entities, including both small
manufacturers of CCERs and the small mining operators that are required
to purchase them, within the meaning of the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an
agency to invite public comment on and to obtain OMB approval of any
rule of general applicability that requires recordkeeping, reporting,
or disclosure requirements.
NIOSH has obtained approval from OMB to collect information from
respirator manufacturers under ``Information Collection Provisions in
42 CFR Part 84--Tests and Requirements for Certification and Approval
of Respiratory Protective Devices'' (OMB Control No. 0920-0109, exp.
November 30, 2017), which covers information collected under 42 CFR
part 84. This rulemaking does not increase the reporting burden on
respirator manufacturers.
D. 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.), the Department
will report the promulgation of this rule to Congress prior to its
effective date. The report will state that the Department has concluded
that this rule is not a ``major rule'' because it is not likely to
result in an annual effect on the economy of $100 million or more.
E. 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 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. For 2014, the inflation-adjusted threshold is
$152 million.
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. NIOSH has provided clear deadline
extension requirements that will be applied uniformly to all
applications from manufacturers of CCERs. This rule has been reviewed
carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The rule does 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.''
H. 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 rule on children. HHS
has determined that the rule would have no effect on children.
I. 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 rule on energy supply, distribution or use, and has
determined that the rule will not have a significant adverse effect.
J. 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 the public how to comply with a requirement the Federal
Government administers or enforces. HHS has attempted to use plain
language in promulgating the interim final rule consistent with the
Federal Plain Writing Act guidelines.
List of Subjects in 42 CFR Part 84
Incorporation by reference, Mine safety and health, Occupational
safety and health, Personal protective equipment, Respirators.
Interim Final Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 42 CFR part 84 as follows:
PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
0
1. The authority citation for Part 84 is revised to read as follows:
Authority: 29 U.S.C. 651 et seq., 30 U.S.C. 3, 5, 7, 811,
842(h), 844.
0
2. Revise Sec. 84.301 to read as follows:
Sec. 84.301 Applicability to new and previously approved CCERs.
(a) The continued manufacturing, labeling, and sale of CCERs
previously approved under Subpart H is authorized for units with
durations comparable to Cap 1 (for mining applications) and Cap 3
(mining and non-mining applications) until either April 9, 2015 or 6
months after the date of the first NIOSH approval of a respirator model
under each respective category specified, whichever date comes later.
(b) Any manufacturer-requested modification to a device approved
under the former subpart H standards must comply with the former
subpart H standards 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
number must meet and be
[[Page 4805]]
issued approvals under the requirements of this subpart O.
(c) This subpart O applies to all CCERs submitted to NIOSH for a
certificate of approval after April 9, 2012.
Dated: January 14, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-01057 Filed 1-28-15; 8:45 am]
BILLING CODE 4163-18-P
