83 FR 12527 - Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical Amendments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 56 (March 22, 2018)

The Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS. The revision to the text in this paragraph will clarify the scope of post-approval testing conducted by NIOSH.

[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Proposed Rules]
[Pages 12527-12529]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket No. CDC-2018-0003; NIOSH-309]
RIN 0920-AA66


Clarification of Post-Approval Testing Standards for Closed-
Circuit Escape Respirators; Technical Amendments

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS) proposes to 
modify current language found in Title 42 of the Code of Federal 
Regulations which addresses post-approval testing of closed-circuit 
escape respirators (CCERs). The revised language should clarify that 
post-approval testing of CCERs may exclude human subject testing and 
environmental conditioning, at the discretion of the National Institute 
for Occupational Safety and Health (NIOSH) within the Centers for 
Disease Control and Prevention, HHS. The revision to the text in this 
paragraph will clarify the scope of post-approval testing conducted by 
NIOSH.

DATES: Comments must be received by May 21, 2018.

ADDRESSES: Written comments: You may submit comments by any of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2018-0003; NIOSH-309) or Regulation Identifier Number (0920-AA66) 
for this rulemaking. All relevant comments, including any personal 
information provided, will be posted without change to http://www.regulations.gov. For detailed instructions on submitting public 
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket go to http://www.regulations.gov.

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

SUPPLEMENTARY INFORMATION: 

I. Public Participation

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

II. Statutory Authority

    Pursuant to the Occupational Safety and Health (OSH) Act of 1970 
(Pub. L. 91-596), the Organic Act of 1910 (Pub. L. 179), and the 
Federal Mine Safety and Health Act of 1977 (Pub. L. 91-173), NIOSH is 
authorized to approve respiratory equipment and to conduct scientific 
investigations or tests concerning the safety and health of miners and 
other workers.

III. Background

    The provisions in 42 CFR 84.310 govern the procedures NIOSH follows 
in conducting post-approval testing of closed-circuit escape 
respirators (CCERs) sold and distributed to employees. The post-
approval testing program, known as the long-term field evaluation 
(LTFE) program, is designed to ensure the CCERs' continued safety and 
viability as emergency life support after having been exposed to harsh 
environments such as those found in mining. According to the existing 
language in Sec.  84.310(c), post-approval

[[Page 12528]]

testing is conducted pursuant to the methods promulgated in Sec. Sec.  
84.303 through 84.305, which establish general testing conditions and 
requirements, including capacity and performance testing.
    In a rulemaking conducted in March 2012 to update the standards for 
the testing of CCERs,\1\ NIOSH did not specify that neither the human 
subject trials specified in Sec. Sec.  84.303-84.305, nor the 
environmental conditioning specified in Sec.  84.305, would be 
conducted on post-market respirators (devices sold and distributed to 
employees) except at NIOSH's discretion. A clarification about human 
subject testing was issued in a September 2016 policy statement.\2\
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    \1\ 77 FR 14168, March 8, 2012.
    \2\ See NIOSH National Personal Protective Technology Laboratory 
Document No. POL-NPPTL-2016-01, https://www.cdc.gov/niosh/npptl/resources/certpgmspt/pdfs/LTFEpolicyFinalSigned-012617.pdf.
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    NIOSH requires human subject testing only when new or modified 
devices are presented for approval evaluation. The human subject trials 
are included as a final check of functionality in the as-used (worn by 
a human being) mode of operation. The inclusion of human subject tests 
addresses the goal of ensuring that no aspect of a design found to be 
in compliance with the bench tests specified in 42 CFR part 84 is 
compromised by, or fails to adequately accommodate, the needs of the 
human/device interaction. Once established, there is no need to re-
evaluate the apparatus with the aid of human subjects unless the design 
is changed.
    Bench testing, using a breathing and metabolic simulator, 
eliminates the potential for human subjects to suffer adverse effects 
from defective CCERs. A post-market unit that does not function in 
accordance with the NIOSH approval requirements after potential damage 
from exposure to the deployment environment could pose a health risk to 
a human test subject. Further, requiring human subject testing 
constrains the number of fielded units NIOSH is able to test, due to 
the logistical complexity and higher cost of hiring human subjects.\3\
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    \3\ Historically, NIOSH employed both the human subject testing 
and the breathing and metabolic simulator testing to assess the 
results side-by-side, and to ground the simulator testing to the 
human subject results. NIOSH has determined that the simulator can 
reliably replicate human subject testing.
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    Environmental treatments are not conducted on post-market devices, 
because the intent of the post-market evaluation is to assess the 
actual effects of the deployed environment on respirators used in the 
field. The environmental treatments specified in NIOSH regulations 
involve exposing respirators to realistically harsh conditions 
representative of industrial environments in order to assess that they 
are reasonably robust for their intended service. The treatments are 
conducted only during the evaluation of a new or modified respirator 
design submitted to NIOSH for approval.

IV. Summary of Proposed Rule

    The proposed changes to 42 CFR 84.310(c) would reflect current 
NIOSH policy by clarifying that neither human subject testing nor 
environmental testing are required to be routinely conducted on 
respirators obtained by the LTFE program. The revision would allow 
NIOSH to conduct human subject testing or environmental treatments in 
the LTFE program only when NIOSH deems those tests to be necessary.
    The language in existing paragraph (d) would be unchanged, and 
moved into a new paragraph (c)(2). The remainder of the paragraphs in 
Sec.  84.310 would be redesignated accordingly.

V. Regulatory Assessment Requirements

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

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This proposed rule has been determined not to be a ``significant 
regulatory action'' under section 3(f) of E.O. 12866. The revision 
proposed in this notice would allow NIOSH the discretion to determine 
whether to conduct human subject tests or environmental treatments on 
fielded respirators chosen for post-approval testing. The current 
language requires NIOSH to conduct those tests.
    Because this proposed rule is a technical correction and would not 
affect the cost of the activities authorized by 42 CFR 84.310(c), HHS 
has not prepared an economic analysis. Accordingly, 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. Because OMB has determined 
that this rulemaking is not significant, pursuant to E.O. 12866, and 
because it 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. Because no 
substantive changes are being made to 42 CFR 84.310(c) as a result of 
this action, HHS certifies that this proposed rule has ``no significant 
economic impact upon a substantial number of small entities'' within 
the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

D. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on, and to obtain OMB approval of, 
any regulation that requires 10 or more people to report information to 
the agency or to keep certain records. In accordance with section 
3507(d) of the PRA, HHS has determined that the Paperwork Reduction Act 
does apply to information collection and recordkeeping requirements 
included in this rule. 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 11/30/
2017). NIOSH is currently seeking approval for a renewal of the 
information collection; a 30-day notice was published in the Federal 
Register on February 20, 2018 (83 FR 7188). The proposed amendments in 
this rulemaking would not impact the collection of data.

[[Page 12529]]

E. Small Business Regulatory Enforcement Fairness Act

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

F. Unfunded Mandates Reform Act of 1995

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

G. Executive Order 12988 (Civil Justice Reform)

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

H. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule 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.''

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

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

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

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution or use, 
and has determined that the rule will 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 proposed rule consistent with the Federal 
Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 84

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

Proposed Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR 84.310 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.

0
2. Amend Sec.  84.310 by removing paragraph (d), redesignating 
paragraphs (e)-(g) as (d)-(f), and revising paragraph (c) to read 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 (a)(1) and(a) (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 in 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: March 16, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-05775 Filed 3-21-18; 8:45 am]
 BILLING CODE 4163-19-P