Removal of Compliance Deadline for Closed-Circuit Escape Respirators and Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators, 16408-16412 [2019-07935]
Download as PDF
<![CDATA[
16408
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R04–RCRA–2018–0529; FRL–9992–
49–Region 4]
Alabama: Final Authorization of State
Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Final authorization.
AGENCY:
The Environmental Protection
Agency (EPA) is granting Alabama final
authorization for changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). The Agency published a
proposed rule on December 10, 2018
and provided for public comment. The
Agency received three comments in
support of authorizing the Alabama
program changes. These comments can
be reviewed in the docket for this action
under Docket ID No. EPA–R04–RCRA–
2018–0529. No further opportunity for
comment will be provided.
DATES: This final authorization is
effective April 19, 2019.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R04–RCRA–2018–0529. All
documents in the docket are listed on
the https://www.regulations.gov website.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Audrey E. Baker, Materials and Waste
Management Branch, RCR Division, U.S.
Environmental Protection Agency,
Atlanta Federal Center, 61 Forsyth
Street SW, Atlanta, Georgia 30303–8960;
telephone number: (404) 562–8562; fax
number: (404) 562–9964; email address:
baker.audrey@epa.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with RULES
A. What changes to Alabama’s
hazardous waste program is EPA
authorizing with this action?
Alabama submitted final complete
program revision applications, dated
November 2, 2016 and May 11, 2018,
seeking authorization of changes to its
hazardous waste program in accordance
with 40 CFR 271.21. EPA now makes a
final decision that Alabama’s hazardous
waste program revisions that are being
authorized are equivalent to, consistent
with, and no less stringent than the
VerDate Sep<11>2014
15:46 Apr 18, 2019
Jkt 247001
Federal program, and therefore satisfy
all of the requirements necessary to
qualify for final authorization. For a list
of State rules being authorized with this
Final Authorization, please see the
proposed rule published in the
December 10, 2018 Federal Register at
83 FR 63461.
B. What is codification and is EPA
codifying Alabama’s hazardous waste
program as authorized in this rule?
Codification is the process of placing
citations and references to the State’s
statutes and regulations that comprise
the State’s authorized hazardous waste
program into the Code of Federal
Regulations. EPA does this by adding
those citations and references to the
authorized State rules in 40 CFR part
272. EPA is not codifying the
authorization of Alabama’s revisions at
this time. However, EPA reserves the
ability to amend 40 CFR part 272,
subpart B for the authorization of
Alabama’s program changes at a later
date.
C. Statutory and Executive Order
Reviews
This final authorization revises
Alabama’s authorized hazardous waste
management program pursuant to
Section 3006 of RCRA and imposes no
requirements other than those currently
imposed by State law. For further
information on how this authorization
complies with applicable executive
orders and statutory provisions, please
see the Proposed Rule published in the
December 10, 2018 Federal Register at
83 FR 63461. The Congressional Review
Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory
Enforcement Fairness Act of 1996,
generally provides that before a rule
may take effect, the agency
promulgating the rule must submit a
rule report, which includes a copy of
the rule, to each House of the Congress
and to the Comptroller General of the
United States. EPA will submit a report
containing this document and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication in the
Federal Register. A major rule cannot
take effect until 60 days after it is
published in the Federal Register. This
action is not a ‘‘major rule’’ as defined
by 5 U.S.C. 804(2). This final action will
be effective April 19, 2019.
List of Subjects in 40 CFR Part 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous waste, Hazardous waste
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
transportation, Indian lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements.
Authority: This action is issued under the
authority of sections 2002(a), 3006, and
7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, and
6974(b).
Dated: March 30, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019–07922 Filed 4–18–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC–2018–0003; NIOSH–309]
RIN 0920–AA66
[Docket No. CDC–2018–0068; NIOSH–318]
RIN 0920–AA67
Removal of Compliance Deadline for
Closed-Circuit Escape Respirators and
Clarification of Post-Approval Testing
Standards for Closed-Circuit Escape
Respirators
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
AGENCY:
With this deregulatory action,
the Department of Health and Human
Services (HHS) revises regulatory
language to remove a deadline by which
respirator manufacturers must
discontinue the manufacturing, labeling,
and sale of certain self-contained selfrescuer 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. In addition
to removing the compliance deadline,
HHS is also modifying regulatory
language to clarify that post-approval
testing of closed-circuit escape
respirators may exclude human subject
testing and environmental conditioning,
at the discretion of NIOSH.
DATES: This final rule is effective on
May 20, 2019.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Office of the Director,
NIOSH; 1090 Tusculum Avenue, MS:C–
48, Cincinnati, OH 45226; telephone
SUMMARY:
E:\FR\FM\19APR1.SGM
19APR1
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Rules and Regulations
(855) 818–1629 (this is a toll-free
number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
I. Public Participation
Interested persons or organizations
were invited to participate in this
rulemaking by submitting written views,
recommendations, and data. Substantive
comments supportive of this action
were submitted by three interested
parties to the rulemaking docket for the
closed-circuit escape respirator (CCER)
compliance deadline notice of proposed
rulemaking (NPRM), RIN 0920–AA67.1
Commenters included a mining industry
trade association, a mining company,
and a respirator manufacturer. No
comments were received on the postapproval testing standards NPRM, RIN
0920–AA66.2 The public comments are
described in section IV, below.
II. Statutory Authority
Pursuant to the Occupational Safety
and Health (OSH) Act of 1970 (Pub. L.
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
khammond on DSKBBV9HB2PROD with RULES
As discussed in the October 2018
NPRM, NIOSH uses the terms ‘‘selfcontained self-rescuer’’ (SCSR) and
‘‘closed-circuit escape respirator’’
(CCER) to distinguish closed-circuit
devices approved under 42 CFR part 84,
subpart H from those approved under
subpart O, respectively. The SCSRs
approved under subpart H and CCERs
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. SCSRs and CCERs are
1 Notice of proposed rulemaking: Removal of
Compliance Deadline for Closed-Circuit Escape
Respirators, 83 FR 53835 (October 25, 2018). See
Docket No. CDC–2018–0068; NIOSH–318 to read
public comments.
2 Notice of proposed rulemaking: Clarification of
Post-Approval Testing Standards for Closed-Circuit
Escape Respirators; Technical Amendments, 83 FR
12527 (March 22, 2018).
VerDate Sep<11>2014
15:46 Apr 18, 2019
Jkt 247001
used by miners and other workers to
escape dangerous atmospheres.
Since the publication of an April 2017
guidance document in which NIOSH
announced its intent not to revoke any
certificate of approval for subpart H
1-hour SCSRs manufactured, labeled, or
sold prior to June 1, 2019,3 no new
CCER approvals have been issued by the
NIOSH National Personal Protective
Technology Laboratory. Accordingly,
NIOSH 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. HHS published an
NPRM in October 2018 to propose
revising 42 CFR part 84 to allow the
continued manufacturing, labeling, and
sale of subpart H SCSRs with current
certificates of approval, indefinitely.
The need for this rulemaking is
discussed in greater detail in the NPRM,
available in the docket for this action.
HHS also published a March 2018
NPRM to propose the clarification of
regulatory text that failed to specify that
neither the human subject trials
described in 42 CFR 84.303–84.305, nor
the environmental conditioning
described in § 84.305, would be
conducted on post-market respirators
(through the NIOSH National Personal
Protective Technology Laboratory’s
Long-Term Field Evaluation program)
except at NIOSH’s discretion.
IV. Summary of Public Comments and
HHS Response
Three comments were received on the
CCER compliance deadline NPRM. All
three commenters support the HHS
proposal to revise the regulatory
language in §§ 84.70 and 84.301 to allow
the indefinite manufacturing, labeling,
and sale of approved subpart H SCSRs.
One of the commenters expressed
concern about whether subpart H SCSRs
were available in sufficient quantity to
replenish the portion of the inventory
that reached the end of its service life
in 2017 and 2018. The commenter asked
that NIOSH coordinate with MSHA to
determine whether a sufficient number
of SCSRs will be produced to replace
retiring units.
Throughout the history of this action,
at no time was the manufacturing,
labeling, or sale of 1-hour SCSRs for
mining prohibited by the changing
compliance deadline. HHS is not aware
that either SCSR manufacturer stopped
production because of the compliance
deadline extensions, and neither
3 Notice of availability, Closed-Circuit Escape
Respirators; Final Guidance for Industry;
Availability, 82 FR 18002 (April 14, 2017).
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
16409
company has indicated to NIOSH that it
was unable to fill orders to replace outof-date units. NIOSH has and will
continue to work closely with respirator
manufacturers and other industry
stakeholders to ensure the
uninterrupted supply of NIOSHapproved escape respirators.
V. Summary of Final Rule
For the reasons discussed in the
NPRM published in October 2018,
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, with
this final rule HHS now allows 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. Accordingly, § 84.70 is 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
alleviates any confusion about the
applicability of subpart H. The
remainder of the section is unchanged
but for the remaining paragraphs being
redesignated (a) through (d).
Paragraph § 84.301(c) is 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 § 84.301(a) is
redesignated as paragraph (b) and is
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 § 84.301(b) is
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 continues to state that
major modifications to a design
approved under subpart H will render
that approval obsolete. In that case, the
entire resulting redesign must fully meet
the technical requirements of subpart O
and the manufacturer will be issued a
new approval accordingly.
For the reasons discussed in the
March 2018 NPRM, HHS is revising 42
CFR 84.310 to clarify that neither
human subject testing nor
environmental testing is required to be
routinely conducted on respirators
obtained by the NIOSH National
E:\FR\FM\19APR1.SGM
19APR1
16410
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Rules and Regulations
Personal Protective Technology
Laboratory’s Long-Term Field
Evaluation program. The revision allows
NIOSH to forego human subject testing
or environmental treatments in the
Program when NIOSH deems either or
both of those tests to be unnecessary.
The language in existing paragraph (d)
is unchanged, and moved into a new
paragraph (c)(2). The remainder of the
paragraphs in § 84.310 are redesignated
accordingly.
VI. 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 final rule has been determined
not to be a ‘‘significant regulatory
action’’ under section 3(f) of E.O. 12866.
The revision finalized in this notice
allows 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.
Because this final 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
aforementioned 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. Thus,
operators may experience cost-savings,
as discussed below.
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)
eliminate at least two existing
regulations for every new significant
regulation that imposes costs. HHS has
determined that this rulemaking is costsaving because it does not require any
new action by stakeholders and because
mine operators who rely on subpart H
respirators can continue to purchase
them as needed, which is likely to be
more economical for some than
switching to the subpart O devices.
HHS has determined that for most of
the respirator models currently
deployed in underground coal mines,
the cost of a new subpart O CCER is
presently greater than the cost of a
comparable subpart H SCSR. Assuming
that mine operators will replace subpart
H SCSRs that have reached the end of
their service life (10 or 15 years,
depending on the model) with an
identical subpart H SCSR, rather than a
more expensive subpart O CCER, HHS
expects mine operators to experience
cost savings as a result of not being
required to purchase the more costly
units.
To estimate potential cost savings,
HHS reviewed the 2018 inventory of all
SCSRs and CCERs currently used in
underground coal mines. Of the six
models of subpart H SCSRs and three
models of subpart O CCERs in use, HHS
was able to obtain current pricing on six
models (see Table 1).
Executive Order 13771 requires
executive departments and agencies to
TABLE 1—CURRENT PRICES OF SUBPART H SCSRS AND SUBPART O CCERS
Respirator type
Respirator model
Subpart H 1-hour ..........................................................................................................
SRLD ........................................................
EBA 6.5 .....................................................
SR 2000 ....................................................
EBA 7.5 .....................................................
M 20.2 .......................................................
M 20.3 .......................................................
Subpart O Cap 3 ..........................................................................................................
khammond on DSKBBV9HB2PROD with RULES
Subpart H 10-minute ....................................................................................................
Subpart O Cap 1 ..........................................................................................................
Because the price of a subpart H 1hour SRLD is greater than the price of
a comparable subpart O Cap 3 SR 2000,
the portion of the coal mining respirator
market relying on the SRLD models is
not affected and hence was not included
in this analysis. HHS found that,
because the subpart H 1-hour SCSR
manufactured by Ocenco Inc., the EBA
6.5, costs less than the subpart O Cap 3
CCER, the EBA 7.5, mine operators
would save $179.15 per unit by not
VerDate Sep<11>2014
15:46 Apr 18, 2019
Jkt 247001
purchasing the subpart O CCER. By not
replacing the subpart H 10-minute SCSR
manufactured by Ocenco, the M 20.2,
with the subpart O Cap 1 CCER, the M
20.3, mine operators would save $81.00
per unit. By eliminating the compliance
deadline requiring coal mine operators
to purchase newer Subpart O Cap 3
CCERs to replace older Subpart H 1hour SCSRs that have reached the end
of their service life, HHS estimates that
mine operators may experience a cost
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
Per unit cost
($)
$854.05
673.00
831.25
852.15
408.00
489.00
savings between approximately $16
million and $20 million over the course
of the 15 years that subpart H SCSRs
must be replaced (see Tables 2 and 3).
This is likely an over-estimate, since it
is foreseeable that the cost of subpart O
CCERs and the number of coal miners
who must be supplied with escape
respirators will both decrease in future
years.
E:\FR\FM\19APR1.SGM
19APR1
16411
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Rules and Regulations
TABLE 2—COST SAVED BY NOT REPLACING SUBPART H 1-HOUR SCSRS WITH SUBPART O CAP 3 CCERS
[2018 $]
# deployed EBA
6.5 units to be
replaced with EBA
7.5 units
Year
2019
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
2033
Undiscounted
($)
Discounted
3%
($)
Discounted
7%
($)
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
266
439
4,101
11,865
12,131
7,843
12,781
24,943
15,908
14,429
6,795
4,114
9,130
8,531
1,775
47,653.90
78,646.85
734,694.15
2,125,614.75
2,173,268.65
1,405,073.45
2,289,716.15
4,468,538.45
2,849,918.2
2,584,955.35
1,217,324.25
737,023.10
1,635,639.50
1,528,328.65
317,991.25
........................
76,358.23
692,522.71
1,945,150.06
1,930,949.20
1,212,016.36
1,917,637.28
3,633,368.61
2,249,725.48
1,981,109.78
905,810.97
532,425.49
1,147,237.55
1,040,791.81
210,224.01
........................
73,503.35
641,681.87
1,735,139.32
1,657,986.65
1,001,817.37
1,525,637.87
2,782,558.89
1,658,652.39
1,405,957.21
618,765.92
350,159.67
726,223.94
634,256.39
123,317.01
Total cost savings ...............................................................................
..............................
24,194,386.65
19,475,327.54
14,935,657.85
TABLE 3—COST OF REPLACING SUBPART H 10-MINUTE SCSRS WITH SUBPART O CAP 1 CCERS
[2018 $]
# deployed M 20.2
units to be
replaced with M
20.3 units
Year
2019
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
2033
Discounted
3%
($)
Discounted
7%
($)
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
16
35
653
1,070
874
462
1,504
3,647
2,551
2,076
2,412
3,180
2,659
1,318
602
1,296.00
2,835.00
52,893.00
86,670.00
70,794.00
37,422.00
121,824.00
295,407.00
206,631.00
168,156.00
195,372.00
257,580.00
215,379.00
106,758.00
48,762.00
1,258.29
2,672.27
48,402.38
77,066.30
61,066.90
31,340.93
99,055.09
233,194.29
158,362.00
125,124.88
141,136.73
180,666.61
146,673.10
70,577.71
31,300.38
1,211.24
2,476.09
43,176.56
66,120.54
43,540.70
24,934.28
75,871.99
171,926.87
112,386.60
85,490.51
92,821.24
114,365.52
89,382.29
41,400.75
17,676.23
Total cost savings ......................................................................................
..............................
1,867,779.00
1,407,897.86
982,781.41
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
khammond on DSKBBV9HB2PROD with RULES
Undiscounted
($)
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. HHS certifies that
VerDate Sep<11>2014
16:26 Apr 18, 2019
Jkt 247001
this 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
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
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
revisions in this rulemaking would not
impact the collection of data.
E:\FR\FM\19APR1.SGM
19APR1
16412
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Rules and Regulations
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 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 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 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.’’
khammond on DSKBBV9HB2PROD with RULES
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 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 rule on energy supply, distribution
or use, and has determined that the rule
VerDate Sep<11>2014
15:46 Apr 18, 2019
Jkt 247001
would not have a significant adverse
effect.
K. Plain Writing Act of 2010
List of Subjects in 42 CFR Part 84
Mine safety and health, Occupational
safety and health, Personal protective
equipment, Respirators.
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
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.
[Amended]
2. Amend § 84.70 by removing
paragraph (a) and redesignating
paragraphs (b) through (e) as (a) through
(d).
■ 3. Revise § 84.301 to read as follows:
■
§ 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.
■ 4. Amend § 84.310 by revising
paragraph (c), removing paragraph (d),
and redesignating paragraphs (e)
through (g) as (d) through (f).
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
§ 84.310
Post-approval testing.
*
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 rule consistent with
the Federal Plain Writing Act
guidelines.
§ 84.70
The revision reads as follows:
*
*
*
*
(c) NIOSH will conduct such testing
pursuant to the methods specified in
§§ 84.303 through 84.305, except as
provided under paragraphs (c)(1) and (2)
of this section:
(1) Post-approval tests may exclude
human subject testing and
environmental conditioning at the
discretion of NIOSH.
(2) The numbers of units of an
approved CCER to be tested under this
section may exceed the numbers of
units specified for testing in §§ 84.304
and 84.305.
*
*
*
*
*
Dated: April 9, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–07935 Filed 4–18–19; 8:45 am]
BILLING CODE 4163–19–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[WC Docket No. 17–84, WT Docket No. 17–
79; FCC 18–111]
Accelerating Wireline Broadband
Deployment by Removing Barriers to
Infrastructure Investment
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, the
information collection associated with
the Commission’s revised pole
attachment access rules. This document
is consistent with Accelerating Wireline
Broadband Deployment by Removing
Barriers to Infrastructure Investment,
Third Report and Order and Declaratory
Ruling, FCC 18–111, which stated that
the Commission would publish a
document in the Federal Register
announcing the effective date of the
revised rules.
DATES: The amendments to 47 CFR
1.1411, 1.1412, and 1.1415 published at
83 FR 46812, September 14, 2018, are
effective May 20, 2019.
FOR FURTHER INFORMATION CONTACT:
Michael Ray, Attorney Advisor,
Wireline Competition Bureau, at (202)
418–0357, or by email at Michael.Ray@
fcc.gov. For additional information
SUMMARY:
E:\FR\FM\19APR1.SGM
19APR1
]]>Agencies
[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Rules and Regulations]
[Pages 16408-16412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07935]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC-2018-0003; NIOSH-309]
RIN 0920-AA66
[Docket No. CDC-2018-0068; NIOSH-318]
RIN 0920-AA67
Removal of Compliance Deadline for Closed-Circuit Escape
Respirators and Clarification of Post-Approval Testing Standards for
Closed-Circuit Escape Respirators
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With this deregulatory action, the Department of Health and
Human Services (HHS) revises regulatory language to remove 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. In addition to removing the
compliance deadline, HHS is also modifying regulatory language to
clarify that post-approval testing of closed-circuit escape respirators
may exclude human subject testing and environmental conditioning, at
the discretion of NIOSH.
DATES: This final rule is effective on May 20, 2019.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Office of the Director,
NIOSH; 1090 Tusculum Avenue, MS:C-48, Cincinnati, OH 45226; telephone
[[Page 16409]]
(855) 818-1629 (this is a toll-free number); email [email protected].
SUPPLEMENTARY INFORMATION:
I. Public Participation
Interested persons or organizations were invited to participate in
this rulemaking by submitting written views, recommendations, and data.
Substantive comments supportive of this action were submitted by three
interested parties to the rulemaking docket for the closed-circuit
escape respirator (CCER) compliance deadline notice of proposed
rulemaking (NPRM), RIN 0920-AA67.\1\ Commenters included a mining
industry trade association, a mining company, and a respirator
manufacturer. No comments were received on the post-approval testing
standards NPRM, RIN 0920-AA66.\2\ The public comments are described in
section IV, below.
---------------------------------------------------------------------------
\1\ Notice of proposed rulemaking: Removal of Compliance
Deadline for Closed-Circuit Escape Respirators, 83 FR 53835 (October
25, 2018). See Docket No. CDC-2018-0068; NIOSH-318 to read public
comments.
\2\ Notice of proposed rulemaking: Clarification of Post-
Approval Testing Standards for Closed-Circuit Escape Respirators;
Technical Amendments, 83 FR 12527 (March 22, 2018).
---------------------------------------------------------------------------
II. Statutory Authority
Pursuant to the Occupational Safety and Health (OSH) Act of 1970
(Pub. L. 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
As discussed in the October 2018 NPRM, NIOSH uses the terms ``self-
contained self-rescuer'' (SCSR) and ``closed-circuit escape
respirator'' (CCER) to distinguish closed-circuit devices approved
under 42 CFR part 84, subpart H from those approved under subpart O,
respectively. The SCSRs approved under subpart H and CCERs 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. SCSRs and CCERs are used by miners and
other workers to escape dangerous atmospheres.
Since the publication of an April 2017 guidance document in which
NIOSH announced its intent not to revoke any certificate of approval
for subpart H 1-hour SCSRs manufactured, labeled, or sold prior to June
1, 2019,\3\ no new CCER approvals have been issued by the NIOSH
National Personal Protective Technology Laboratory. Accordingly, NIOSH
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.
HHS published an NPRM in October 2018 to propose revising 42 CFR part
84 to allow the continued manufacturing, labeling, and sale of subpart
H SCSRs with current certificates of approval, indefinitely. The need
for this rulemaking is discussed in greater detail in the NPRM,
available in the docket for this action.
---------------------------------------------------------------------------
\3\ Notice of availability, Closed-Circuit Escape Respirators;
Final Guidance for Industry; Availability, 82 FR 18002 (April 14,
2017).
---------------------------------------------------------------------------
HHS also published a March 2018 NPRM to propose the clarification
of regulatory text that failed to specify that neither the human
subject trials described in 42 CFR 84.303-84.305, nor the environmental
conditioning described in Sec. 84.305, would be conducted on post-
market respirators (through the NIOSH National Personal Protective
Technology Laboratory's Long-Term Field Evaluation program) except at
NIOSH's discretion.
IV. Summary of Public Comments and HHS Response
Three comments were received on the CCER compliance deadline NPRM.
All three commenters support the HHS proposal to revise the regulatory
language in Sec. Sec. 84.70 and 84.301 to allow the indefinite
manufacturing, labeling, and sale of approved subpart H SCSRs.
One of the commenters expressed concern about whether subpart H
SCSRs were available in sufficient quantity to replenish the portion of
the inventory that reached the end of its service life in 2017 and
2018. The commenter asked that NIOSH coordinate with MSHA to determine
whether a sufficient number of SCSRs will be produced to replace
retiring units.
Throughout the history of this action, at no time was the
manufacturing, labeling, or sale of 1-hour SCSRs for mining prohibited
by the changing compliance deadline. HHS is not aware that either SCSR
manufacturer stopped production because of the compliance deadline
extensions, and neither company has indicated to NIOSH that it was
unable to fill orders to replace out-of-date units. NIOSH has and will
continue to work closely with respirator manufacturers and other
industry stakeholders to ensure the uninterrupted supply of NIOSH-
approved escape respirators.
V. Summary of Final Rule
For the reasons discussed in the NPRM published in October 2018,
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, with this final rule HHS now allows 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. Accordingly, Sec. 84.70 is 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
alleviates any confusion about the applicability of subpart H. The
remainder of the section is unchanged but for the remaining paragraphs
being redesignated (a) through (d).
Paragraph Sec. 84.301(c) is 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) is redesignated as paragraph (b) and is 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) is 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 continues to state
that major modifications to a design approved under subpart H will
render that approval obsolete. In that case, the entire resulting
redesign must fully meet the technical requirements of subpart O and
the manufacturer will be issued a new approval accordingly.
For the reasons discussed in the March 2018 NPRM, HHS is revising
42 CFR 84.310 to clarify that neither human subject testing nor
environmental testing is required to be routinely conducted on
respirators obtained by the NIOSH National
[[Page 16410]]
Personal Protective Technology Laboratory's Long-Term Field Evaluation
program. The revision allows NIOSH to forego human subject testing or
environmental treatments in the Program when NIOSH deems either or both
of those tests to be unnecessary. The language in existing paragraph
(d) is unchanged, and moved into a new paragraph (c)(2). The remainder
of the paragraphs in Sec. 84.310 are redesignated accordingly.
VI. 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 final rule has been determined not to be a ``significant
regulatory action'' under section 3(f) of E.O. 12866. The revision
finalized in this notice allows 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.
Because this final 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 aforementioned 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. Thus, operators may experience cost-savings, as discussed
below.
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-saving because it does not require any new action by
stakeholders and because mine operators who rely on subpart H
respirators can continue to purchase them as needed, which is likely to
be more economical for some than switching to the subpart O devices.
HHS has determined that for most of the respirator models currently
deployed in underground coal mines, the cost of a new subpart O CCER is
presently greater than the cost of a comparable subpart H SCSR.
Assuming that mine operators will replace subpart H SCSRs that have
reached the end of their service life (10 or 15 years, depending on the
model) with an identical subpart H SCSR, rather than a more expensive
subpart O CCER, HHS expects mine operators to experience cost savings
as a result of not being required to purchase the more costly units.
To estimate potential cost savings, HHS reviewed the 2018 inventory
of all SCSRs and CCERs currently used in underground coal mines. Of the
six models of subpart H SCSRs and three models of subpart O CCERs in
use, HHS was able to obtain current pricing on six models (see Table
1).
Table 1--Current Prices of Subpart H SCSRs and Subpart O CCERs
------------------------------------------------------------------------
Per unit cost
Respirator type Respirator model ($)
------------------------------------------------------------------------
Subpart H 1-hour.................. SRLD................ $854.05
EBA 6.5............. 673.00
Subpart O Cap 3................... SR 2000............. 831.25
EBA 7.5............. 852.15
Subpart H 10-minute............... M 20.2.............. 408.00
Subpart O Cap 1................... M 20.3.............. 489.00
------------------------------------------------------------------------
Because the price of a subpart H 1-hour SRLD is greater than the
price of a comparable subpart O Cap 3 SR 2000, the portion of the coal
mining respirator market relying on the SRLD models is not affected and
hence was not included in this analysis. HHS found that, because the
subpart H 1-hour SCSR manufactured by Ocenco Inc., the EBA 6.5, costs
less than the subpart O Cap 3 CCER, the EBA 7.5, mine operators would
save $179.15 per unit by not purchasing the subpart O CCER. By not
replacing the subpart H 10-minute SCSR manufactured by Ocenco, the M
20.2, with the subpart O Cap 1 CCER, the M 20.3, mine operators would
save $81.00 per unit. By eliminating the compliance deadline requiring
coal mine operators to purchase newer Subpart O Cap 3 CCERs to replace
older Subpart H 1-hour SCSRs that have reached the end of their service
life, HHS estimates that mine operators may experience a cost savings
between approximately $16 million and $20 million over the course of
the 15 years that subpart H SCSRs must be replaced (see Tables 2 and
3). This is likely an over-estimate, since it is foreseeable that the
cost of subpart O CCERs and the number of coal miners who must be
supplied with escape respirators will both decrease in future years.
[[Page 16411]]
Table 2--Cost Saved by Not Replacing Subpart H 1-Hour SCSRs With Subpart O Cap 3 CCERs
[2018 $]
----------------------------------------------------------------------------------------------------------------
# deployed EBA
6.5 units to be Undiscounted Discounted 3% Discounted 7%
Year replaced with EBA ($) ($) ($)
7.5 units
----------------------------------------------------------------------------------------------------------------
2019......................................... 266 47,653.90 .............. ..............
2020......................................... 439 78,646.85 76,358.23 73,503.35
2021......................................... 4,101 734,694.15 692,522.71 641,681.87
2022......................................... 11,865 2,125,614.75 1,945,150.06 1,735,139.32
2023......................................... 12,131 2,173,268.65 1,930,949.20 1,657,986.65
2024......................................... 7,843 1,405,073.45 1,212,016.36 1,001,817.37
2025......................................... 12,781 2,289,716.15 1,917,637.28 1,525,637.87
2026......................................... 24,943 4,468,538.45 3,633,368.61 2,782,558.89
2027......................................... 15,908 2,849,918.2 2,249,725.48 1,658,652.39
2028......................................... 14,429 2,584,955.35 1,981,109.78 1,405,957.21
2029......................................... 6,795 1,217,324.25 905,810.97 618,765.92
2030......................................... 4,114 737,023.10 532,425.49 350,159.67
2031......................................... 9,130 1,635,639.50 1,147,237.55 726,223.94
2032......................................... 8,531 1,528,328.65 1,040,791.81 634,256.39
2033......................................... 1,775 317,991.25 210,224.01 123,317.01
------------------------------------------------------------------
Total cost savings....................... ................. 24,194,386.65 19,475,327.54 14,935,657.85
----------------------------------------------------------------------------------------------------------------
Table 3--Cost of Replacing Subpart H 10-Minute SCSRs With Subpart O Cap 1 CCERs
[2018 $]
----------------------------------------------------------------------------------------------------------------
# deployed M 20.2
units to be Undiscounted Discounted 3% Discounted 7%
Year replaced with M ($) ($) ($)
20.3 units
----------------------------------------------------------------------------------------------------------------
2019......................................... 16 1,296.00 1,258.29 1,211.24
2020......................................... 35 2,835.00 2,672.27 2,476.09
2021......................................... 653 52,893.00 48,402.38 43,176.56
2022......................................... 1,070 86,670.00 77,066.30 66,120.54
2023......................................... 874 70,794.00 61,066.90 43,540.70
2024......................................... 462 37,422.00 31,340.93 24,934.28
2025......................................... 1,504 121,824.00 99,055.09 75,871.99
2026......................................... 3,647 295,407.00 233,194.29 171,926.87
2027......................................... 2,551 206,631.00 158,362.00 112,386.60
2028......................................... 2,076 168,156.00 125,124.88 85,490.51
2029......................................... 2,412 195,372.00 141,136.73 92,821.24
2030......................................... 3,180 257,580.00 180,666.61 114,365.52
2031......................................... 2,659 215,379.00 146,673.10 89,382.29
2032......................................... 1,318 106,758.00 70,577.71 41,400.75
2033......................................... 602 48,762.00 31,300.38 17,676.23
------------------------------------------------------------------
Total cost savings........................... ................. 1,867,779.00 1,407,897.86 982,781.41
----------------------------------------------------------------------------------------------------------------
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 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 revisions in this rulemaking would not impact the collection
of data.
[[Page 16412]]
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 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 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 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 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 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 the public how to comply with a requirement the Federal
government administers or enforces. HHS has attempted to use plain
language in promulgating the 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.
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 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.
0
4. Amend Sec. 84.310 by revising paragraph (c), removing paragraph
(d), and redesignating paragraphs (e) through (g) as (d) through (f).
The revision reads as follows:
Sec. 84.310 Post-approval testing.
* * * * *
(c) NIOSH will conduct such testing pursuant to the methods
specified in Sec. Sec. 84.303 through 84.305, except as provided under
paragraphs (c)(1) and (2) of this section:
(1) Post-approval tests may exclude human subject testing and
environmental conditioning at the discretion of NIOSH.
(2) The numbers of units of an approved CCER to be tested under
this section may exceed the numbers of units specified for testing in
Sec. Sec. 84.304 and 84.305.
* * * * *
Dated: April 9, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-07935 Filed 4-18-19; 8:45 am]
BILLING CODE 4163-19-P
