83_FR_12583 83 FR 12527 - Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical Amendments

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)

Page Range12527-12529
FR Document2018-05775

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 Issue 56 (Thursday, March 22, 2018)
[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.

-----------------------------------------------------------------------

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 NIOSHregs@cdc.gov.

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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



                                                                        Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Proposed Rules                                          12527

                                                 infrastructure in place to address all                  methods, under Executive Order 12898                  Tusculum Avenue, Cincinnati, OH
                                                 applicable required elements of sections                (59 FR 7629, February 16, 1994).                      45226.
                                                 110(a)(1) and (2) (except otherwise                       The SIP is not approved to apply on                   Instructions: All submissions received
                                                 noted) to ensure that the 2012 PM2.5,                   any Indian reservation land or in any                 must include the agency name (Centers
                                                 NAAQS are implemented in the state.                     other area where EPA or an Indian tribe               for Disease Control and Prevention,
                                                                                                         has demonstrated that a tribe has                     HHS) and docket number (CDC–2018–
                                                 IV. Statutory and Executive Order                       jurisdiction. In those areas of Indian                0003; NIOSH–309) or Regulation
                                                 Reviews                                                 country, the proposed rule does not                   Identifier Number (0920–AA66) for this
                                                    Under the CAA, the Administrator is                  have tribal implications and will not                 rulemaking. All relevant comments,
                                                 required to approve a SIP submission                    impose substantial direct costs on tribal             including any personal information
                                                 that complies with the provisions of the                governments or preempt tribal law as                  provided, will be posted without change
                                                 Act and applicable Federal regulations.                 specified by Executive Order 13175 (65                to http://www.regulations.gov. For
                                                 42 U.S.C. 7410(k); 40 CFR 52.02(a).                     FR 67249, November 9, 2000).                          detailed instructions on submitting
                                                 Thus, in reviewing SIP submissions,                                                                           public comments, see the ‘‘Public
                                                                                                         List of Subjects in 40 CFR Part 52
                                                 EPA’s role is to approve state choices,                                                                       Participation’’ heading of the
                                                 provided that they meet the criteria of                   Environmental protection, Air                       SUPPLEMENTARY INFORMATION section of
                                                 the CAA. Accordingly, this action                       pollution control, Incorporation by                   this document.
                                                 merely proposes to approve state law as                 reference, Particulate matter.                          Docket: For access to the docket go to
                                                 meeting Federal requirements and does                     Authority: 42 U.S.C. 7401 et seq.                   http://www.regulations.gov.
                                                 not impose additional requirements                        Dated: March 16, 2018.                              FOR FURTHER INFORMATION CONTACT:
                                                 beyond those imposed by state law. For                  Anne Idsal,
                                                                                                                                                               Rachel Weiss, Office of the Director,
                                                 that reason, this action:                                                                                     NIOSH; 1090 Tusculum Avenue, MS:C–
                                                                                                         Regional Administrator, Region 6.
                                                    • Is not a ‘‘significant regulatory                                                                        48, Cincinnati, OH 45226; telephone
                                                                                                         [FR Doc. 2018–05767 Filed 3–21–18; 8:45 am]
                                                 action’’ subject to review by the Office                                                                      (855) 818–1629 (this is a toll-free
                                                                                                         BILLING CODE 6560–50–P                                number); email NIOSHregs@cdc.gov.
                                                 of Management and Budget under
                                                 Executive Orders 12866 (58 FR 51735,                                                                          SUPPLEMENTARY INFORMATION:
                                                 October 4, 1993) and 13563 (76 FR 3821,                                                                       I. Public Participation
                                                 January 21, 2011);                                      DEPARTMENT OF HEALTH AND
                                                    • Is not an Executive Order 13771 (82                HUMAN SERVICES                                           Interested parties may participate in
                                                 FR 9339, February 2, 2017) regulatory                                                                         this rulemaking by submitting written
                                                                                                         42 CFR Part 84                                        views, opinions, recommendations, and
                                                 action because SIP approvals are
                                                 exempted under Executive Order 12866;                   [Docket No. CDC–2018–0003; NIOSH–309]                 data. Comments received, including
                                                    • Does not impose an information                                                                           attachments and other supporting
                                                                                                         RIN 0920–AA66
                                                 collection burden under the provisions                                                                        materials, are part of the public record
                                                 of the Paperwork Reduction Act (44                      Clarification of Post-Approval Testing                and subject to public disclosure. Do not
                                                 U.S.C. 3501 et seq.);                                   Standards for Closed-Circuit Escape                   include any information in your
                                                    • Is certified as not having a                       Respirators; Technical Amendments                     comment or supporting materials that
                                                 significant economic impact on a                                                                              you do not wish to be disclosed. You
                                                                                                         AGENCY: Centers for Disease Control and               may submit comments on any topic
                                                 substantial number of small entities                    Prevention, HHS.
                                                 under the Regulatory Flexibility Act (5                                                                       related to this notice of proposed
                                                                                                         ACTION: Notice of proposed rulemaking.                rulemaking.
                                                 U.S.C. 601 et seq.);
                                                    • Does not contain any unfunded                      SUMMARY:   The Department of Health and               II. Statutory Authority
                                                 mandate or significantly or uniquely                    Human Services (HHS) proposes to                         Pursuant to the Occupational Safety
                                                 affect small governments, as described                  modify current language found in Title                and Health (OSH) Act of 1970 (Pub. L.
                                                 in the Unfunded Mandates Reform Act                     42 of the Code of Federal Regulations                 91–596), the Organic Act of 1910 (Pub.
                                                 of 1995 (Pub. L. 104–4);                                which addresses post-approval testing                 L. 179), and the Federal Mine Safety and
                                                    • Does not have Federalism                           of closed-circuit escape respirators                  Health Act of 1977 (Pub. L. 91–173),
                                                 implications as specified in Executive                  (CCERs). The revised language should                  NIOSH is authorized to approve
                                                 Order 13132 (64 FR 43255, August 10,                    clarify that post-approval testing of                 respiratory equipment and to conduct
                                                 1999);                                                  CCERs may exclude human subject                       scientific investigations or tests
                                                    • Is not an economically significant                 testing and environmental conditioning,               concerning the safety and health of
                                                 regulatory action based on health or                    at the discretion of the National Institute           miners and other workers.
                                                 safety risks subject to Executive Order                 for Occupational Safety and Health
                                                 13045 (62 FR 19885, April 23, 1997);                    (NIOSH) within the Centers for Disease                III. Background
                                                    • Is not a significant regulatory action             Control and Prevention, HHS. The                         The provisions in 42 CFR 84.310
                                                 subject to Executive Order 13211 (66 FR                 revision to the text in this paragraph                govern the procedures NIOSH follows in
                                                 28355, May 22, 2001);                                   will clarify the scope of post-approval               conducting post-approval testing of
                                                    • Is not subject to requirements of                  testing conducted by NIOSH.                           closed-circuit escape respirators
                                                 section 12(d) of the National                           DATES: Comments must be received by                   (CCERs) sold and distributed to
                                                 Technology Transfer and Advancement                     May 21, 2018.                                         employees. The post-approval testing
daltland on DSKBBV9HB2PROD with PROPOSALS




                                                 Act of 1995 (15 U.S.C. 272 note) because                ADDRESSES: Written comments: You may                  program, known as the long-term field
                                                 application of those requirements would                 submit comments by any of the                         evaluation (LTFE) program, is designed
                                                 be inconsistent with the CAA; and                       following methods:                                    to ensure the CCERs’ continued safety
                                                    • Does not provide EPA with the                         • Federal eRulemaking Portal: http://              and viability as emergency life support
                                                 discretionary authority to address, as                  www.regulations.gov. Follow the                       after having been exposed to harsh
                                                 appropriate, disproportionate human                     instructions for submitting comments.                 environments such as those found in
                                                 health or environmental effects, using                     • Mail: NIOSH Docket Office, Robert                mining. According to the existing
                                                 practicable and legally permissible                     A. Taft Laboratories, MS–C34, 1090                    language in § 84.310(c), post-approval


                                            VerDate Sep<11>2014   18:44 Mar 21, 2018   Jkt 244001   PO 00000   Frm 00024   Fmt 4702   Sfmt 4702   E:\FR\FM\22MRP1.SGM   22MRP1


                                                 12528                   Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Proposed Rules

                                                 testing is conducted pursuant to the                    respirators used in the field. The                    and Budget (OMB) has not reviewed this
                                                 methods promulgated in §§ 84.303                        environmental treatments specified in                 rulemaking.
                                                 through 84.305, which establish general                 NIOSH regulations involve exposing
                                                 testing conditions and requirements,                    respirators to realistically harsh                    B. Executive Order 13771 (Reducing
                                                 including capacity and performance                      conditions representative of industrial               Regulation and Controlling Regulatory
                                                 testing.                                                environments in order to assess that                  Costs)
                                                    In a rulemaking conducted in March                   they are reasonably robust for their                     Executive Order 13771 requires
                                                 2012 to update the standards for the                    intended service. The treatments are
                                                 testing of CCERs,1 NIOSH did not                                                                              executive departments and agencies to
                                                                                                         conducted only during the evaluation of               eliminate at least two existing
                                                 specify that neither the human subject                  a new or modified respirator design
                                                 trials specified in §§ 84.303–84.305, nor                                                                     regulations for every new significant
                                                                                                         submitted to NIOSH for approval.
                                                 the environmental conditioning                                                                                regulation that imposes costs. Because
                                                 specified in § 84.305, would be                         IV. Summary of Proposed Rule                          OMB has determined that this
                                                 conducted on post-market respirators                                                                          rulemaking is not significant, pursuant
                                                                                                            The proposed changes to 42 CFR
                                                 (devices sold and distributed to                                                                              to E.O. 12866, and because it does not
                                                                                                         84.310(c) would reflect current NIOSH
                                                 employees) except at NIOSH’s                                                                                  impose costs, OMB has determined that
                                                                                                         policy by clarifying that neither human
                                                 discretion. A clarification about human                 subject testing nor environmental                     this rulemaking is exempt from the
                                                 subject testing was issued in a                         testing are required to be routinely                  requirements of E.O. 13771. Thus it has
                                                 September 2016 policy statement.2                       conducted on respirators obtained by                  not been reviewed by OMB.
                                                    NIOSH requires human subject testing                 the LTFE program. The revision would
                                                 only when new or modified devices are                                                                         C. Regulatory Flexibility Act
                                                                                                         allow NIOSH to conduct human subject
                                                 presented for approval evaluation. The                  testing or environmental treatments in                  The Regulatory Flexibility Act (RFA),
                                                 human subject trials are included as a                  the LTFE program only when NIOSH                      5 U.S.C. 601 et seq., requires each
                                                 final check of functionality in the as-                 deems those tests to be necessary.                    agency to consider the potential impact
                                                 used (worn by a human being) mode of
                                                                                                            The language in existing paragraph (d)             of its regulations on small entities
                                                 operation. The inclusion of human
                                                                                                         would be unchanged, and moved into a                  including small businesses, small
                                                 subject tests addresses the goal of
                                                                                                         new paragraph (c)(2). The remainder of                governmental units, and small not-for-
                                                 ensuring that no aspect of a design
                                                 found to be in compliance with the                      the paragraphs in § 84.310 would be                   profit organizations. Because no
                                                 bench tests specified in 42 CFR part 84                 redesignated accordingly.                             substantive changes are being made to
                                                 is compromised by, or fails to                                                                                42 CFR 84.310(c) as a result of this
                                                                                                         V. Regulatory Assessment
                                                 adequately accommodate, the needs of                                                                          action, HHS certifies that this proposed
                                                                                                         Requirements
                                                 the human/device interaction. Once                                                                            rule has ‘‘no significant economic
                                                 established, there is no need to re-                    A. Executive Order 12866 (Regulatory                  impact upon a substantial number of
                                                 evaluate the apparatus with the aid of                  Planning and Review) and Executive                    small entities’’ within the meaning of
                                                 human subjects unless the design is                     Order 13563 (Improving Regulation and                 the Regulatory Flexibility Act (5 U.S.C.
                                                 changed.                                                Regulatory Review)                                    601 et seq.).
                                                    Bench testing, using a breathing and                    Executive Orders 12866 and 13563                   D. Paperwork Reduction Act
                                                 metabolic simulator, eliminates the                     direct agencies to assess all costs and
                                                 potential for human subjects to suffer                  benefits of available regulatory                        The Paperwork Reduction Act (PRA),
                                                 adverse effects from defective CCERs. A                 alternatives and, if regulation is                    44 U.S.C. 3501 et seq., requires an
                                                 post-market unit that does not function                 necessary, to select regulatory                       agency to invite public comment on,
                                                 in accordance with the NIOSH approval                   approaches that maximize net benefits                 and to obtain OMB approval of, any
                                                 requirements after potential damage                     (including potential economic,                        regulation that requires 10 or more
                                                 from exposure to the deployment                         environmental, public health and safety               people to report information to the
                                                 environment could pose a health risk to                 effects, distributive impacts, and                    agency or to keep certain records. In
                                                 a human test subject. Further, requiring                equity). E.O. 13563 emphasizes the                    accordance with section 3507(d) of the
                                                 human subject testing constrains the                    importance of quantifying both costs                  PRA, HHS has determined that the
                                                 number of fielded units NIOSH is able                   and benefits, of reducing costs, of                   Paperwork Reduction Act does apply to
                                                 to test, due to the logistical complexity               harmonizing rules, and of promoting                   information collection and
                                                 and higher cost of hiring human                         flexibility.                                          recordkeeping requirements included in
                                                 subjects.3                                                                                                    this rule. The Office of Management and
                                                    Environmental treatments are not                        This proposed rule has been
                                                                                                         determined not to be a ‘‘significant                  Budget (OMB) has already approved the
                                                 conducted on post-market devices,
                                                                                                         regulatory action’’ under section 3(f) of             information collection and
                                                 because the intent of the post-market
                                                                                                         E.O. 12866. The revision proposed in                  recordkeeping requirements under OMB
                                                 evaluation is to assess the actual effects
                                                                                                         this notice would allow NIOSH the                     Control Number 0920–0109,
                                                 of the deployed environment on
                                                                                                         discretion to determine whether to                    Information Collection Provisions in 42
                                                   1 77 FR 14168, March 8, 2012.
                                                                                                         conduct human subject tests or                        CFR part 84—Tests and Requirements
                                                   2 See  NIOSH National Personal Protective             environmental treatments on fielded                   for Certification and Approval of
                                                 Technology Laboratory Document No. POL–                 respirators chosen for post-approval                  Respiratory Protective Devices
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                                                 NPPTL–2016–01, https://www.cdc.gov/niosh/npptl/         testing. The current language requires                (expiration date 11/30/2017). NIOSH is
                                                 resources/certpgmspt/pdfs/LTFEpolicyFinalSigned-        NIOSH to conduct those tests.
                                                 012617.pdf.
                                                                                                                                                               currently seeking approval for a renewal
                                                   3 Historically, NIOSH employed both the human            Because this proposed rule is a                    of the information collection; a 30-day
                                                 subject testing and the breathing and metabolic         technical correction and would not                    notice was published in the Federal
                                                 simulator testing to assess the results side-by-side,   affect the cost of the activities                     Register on February 20, 2018 (83 FR
                                                 and to ground the simulator testing to the human                                                              7188). The proposed amendments in
                                                 subject results. NIOSH has determined that the
                                                                                                         authorized by 42 CFR 84.310(c), HHS
                                                 simulator can reliably replicate human subject          has not prepared an economic analysis.                this rulemaking would not impact the
                                                 testing.                                                Accordingly, the Office of Management                 collection of data.


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                                                                        Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Proposed Rules                                          12529

                                                 E. Small Business Regulatory                            distribution or use, and has determined               DEPARTMENT OF TRANSPORTATION
                                                 Enforcement Fairness Act                                that the rule will not have a significant
                                                    As required by Congress under the                    adverse effect.                                       Pipeline and Hazardous Materials
                                                 Small Business Regulatory Enforcement                                                                         Safety Administration
                                                                                                         K. Plain Writing Act of 2010
                                                 Fairness Act of 1996 (5 U.S.C. 801 et
                                                 seq.), HHS will report the promulgation                                                                       49 CFR Parts 107, 171, 172, 173, 174,
                                                                                                            Under Public Law 111–274 (October
                                                 of this rule to Congress prior to its                                                                         177, 178, 179, and 180
                                                                                                         13, 2010), executive Departments and
                                                 effective date.                                         Agencies are required to use plain                    [Docket No. PHMSA–2018–0001; Notice No.
                                                                                                         language in documents that explain to                 2018–01]
                                                 F. Unfunded Mandates Reform Act of
                                                 1995                                                    the public how to comply with a
                                                                                                                                                               Request for Information on Regulatory
                                                                                                         requirement the Federal government
                                                    Title II of the Unfunded Mandates                                                                          Challenges to Safely Transporting
                                                 Reform Act of 1995 (2 U.S.C. 1531 et                    administers or enforces. HHS has                      Hazardous Materials by Surface Modes
                                                 seq.) directs agencies to assess the                    attempted to use plain language in                    in an Automated Vehicle Environment
                                                 effects of Federal regulatory actions on                promulgating the proposed rule
                                                 State, local, and Tribal governments,                   consistent with the Federal Plain                     AGENCY:  Pipeline and Hazardous
                                                 and the private sector ‘‘other than to the              Writing Act guidelines.                               Materials Safety Administration
                                                 extent that such regulations incorporate                                                                      (PHMSA), Department of Transportation
                                                                                                         List of Subjects in 42 CFR Part 84                    (DOT).
                                                 requirements specifically set forth in
                                                 law.’’ For purposes of the Unfunded                       Mine safety and health, Occupational                ACTION: Request for information.
                                                 Mandates Reform Act, this proposed                      safety and health, Personal protective                SUMMARY:   The Pipeline and Hazardous
                                                 rule does not include any Federal                       equipment, Respirators.                               Materials Safety Administration
                                                 mandate that may result in increased
                                                                                                         Proposed Rule                                         (PHMSA) requests information on
                                                 annual expenditures in excess of $100
                                                                                                                                                               matters related to the development and
                                                 million by State, local or Tribal
                                                                                                           For the reasons discussed in the                    potential use of automated technologies
                                                 governments in the aggregate, or by the
                                                                                                         preamble, the Department of Health and                for surface modes (i.e., highway and
                                                 private sector.
                                                                                                         Human Services proposes to amend 42                   rail) in hazardous materials
                                                 G. Executive Order 12988 (Civil Justice                 CFR 84.310 as follows:                                transportation. In anticipation of the
                                                 Reform)                                                                                                       development, testing, and integration of
                                                   This proposed rule has been drafted                   PART 84—APPROVAL OF                                   Automated Driving Systems in surface
                                                 and reviewed in accordance with                         RESPIRATORY PROTECTIVE DEVICES                        transportation, PHMSA is issuing this
                                                 Executive Order 12988 and will not                                                                            request for information on the factors
                                                 unduly burden the Federal court                         ■ 1. The authority citation for part 84               the Agency should consider to ensure
                                                 system. This rule has been reviewed                     continues to read as follows:                         continued safe transportation of
                                                 carefully to eliminate drafting errors and                                                                    hazardous materials without impeding
                                                                                                            Authority: 29 U.S.C. 651 et seq.; 30 U.S.C.
                                                 ambiguities.                                                                                                  emerging surface transportation
                                                                                                         3, 5, 7, 811, 842(h), 844.
                                                                                                                                                               technologies.
                                                 H. Executive Order 13132 (Federalism)
                                                                                                         ■ 2. Amend § 84.310 by removing                       DATES:  Interested persons are invited to
                                                    HHS has reviewed this proposed rule                  paragraph (d), redesignating paragraphs               submit comments on or before May 7,
                                                 in accordance with Executive Order                      (e)–(g) as (d)–(f), and revising paragraph            2018. Comments received after that date
                                                 13132 regarding federalism, and has                     (c) to read as follows:                               will be considered to the extent
                                                 determined that it does not have                                                                              practicable.
                                                 ‘‘federalism implications.’’ The rule                   § 84.310    Post-approval testing.
                                                 does not ‘‘have substantial direct effects                                                                    ADDRESSES:  You may submit comments
                                                                                                         *      *     *    *     *                             identified by Docket Number PHMSA–
                                                 on the States, on the relationship
                                                                                                           (c) NIOSH will conduct such testing                 2018–0001 via any of the following
                                                 between the national government and
                                                 the States, or on the distribution of                   pursuant to the methods specified in                  methods:
                                                 power and responsibilities among the                    §§ 84.303 through 84.305, except as                     • Federal eRulemaking Portal: Go to
                                                 various levels of government.’’                         provided under paragraphs (a)(1) and(a)               http://www.regulations.gov. Follow the
                                                                                                         (2) of this section:.                                 online instructions for submitting
                                                 I. Executive Order 13045 (Protection of                                                                       comments.
                                                                                                           (1) Post-approval tests may exclude
                                                 Children From Environmental Health
                                                                                                         human subject testing and                               • Fax: 1–202–493–2251.
                                                 Risks and Safety Risks)                                                                                         • Mail: Docket Operations, U.S.
                                                                                                         environmental conditioning at the
                                                    In accordance with Executive Order                                                                         Department of Transportation, West
                                                                                                         discretion of NIOSH.
                                                 13045, HHS has evaluated the                                                                                  Building, Ground Floor, Room W12–
                                                 environmental health and safety effects                   (2) The numbers of units in an                      140, Routing Symbol M–30, 1200 New
                                                 of this proposed rule on children. HHS                  approved CCER to be tested under this                 Jersey Avenue SE, Washington, DC
                                                 has determined that the rule would have                 section may exceed the numbers of                     20590.
                                                 no environmental health and safety                      units specified for testing in §§ 84.304                • Hand Delivery: To Docket
                                                 effect on children.                                     and 84.305.                                           Operations, Room W12–140 on the
daltland on DSKBBV9HB2PROD with PROPOSALS




                                                                                                           Dated: March 16, 2018.                              ground floor of the West Building, 1200
                                                 J. Executive Order 13211 (Actions                                                                             New Jersey Avenue SE, Washington, DC
                                                 Concerning Regulations That                             Alex M. Azar II,
                                                                                                                                                               20590, between 9 a.m. and 5 p.m.,
                                                 Significantly Affect Energy Supply,                     Secretary, Department of Health and Human             Monday through Friday, except Federal
                                                 Distribution, or Use)                                   Services.                                             holidays.
                                                    In accordance with Executive Order                   [FR Doc. 2018–05775 Filed 3–21–18; 8:45 am]             Instructions: All submissions must
                                                 13211, HHS has evaluated the effects of                 BILLING CODE 4163–19–P                                include the agency name and docket
                                                 this proposed rule on energy supply,                                                                          number for this notice. Internet users


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Document Created: 2018-03-22 01:24:48
Document Modified: 2018-03-22 01:24:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking.
DatesComments must be received by May 21, 2018.
ContactRachel 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]
FR Citation83 FR 12527 
RIN Number0920-AA66
CFR AssociatedMine Safety and Health; Occupational Safety and Health; Personal Protective Equipment and Respirators

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