[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]


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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.

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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.
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    \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).
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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.
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    \3\ Notice of availability, Closed-Circuit Escape Respirators; 
Final Guidance for Industry; Availability, 82 FR 18002 (April 14, 
2017).
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    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 $]
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                                                 # deployed EBA
                                                6.5 units to be    Undiscounted    Discounted 3%   Discounted 7%
                     Year                      replaced with EBA        ($)             ($)             ($)
                                                   7.5 units
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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
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    Total cost savings.......................  .................   24,194,386.65   19,475,327.54   14,935,657.85
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                 Table 3--Cost of Replacing Subpart H 10-Minute SCSRs With Subpart O Cap 1 CCERs
                                                    [2018 $]
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                                               # deployed M 20.2
                                                  units to be      Undiscounted    Discounted 3%   Discounted 7%
                     Year                       replaced with M         ($)             ($)             ($)
                                                   20.3 units
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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
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Total cost savings...........................  .................    1,867,779.00    1,407,897.86      982,781.41
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    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