Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical Amendments, 12527-12529 [2018-05775]

Download as PDF Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Proposed Rules infrastructure in place to address all applicable required elements of sections 110(a)(1) and (2) (except otherwise noted) to ensure that the 2012 PM2.5, NAAQS are implemented in the state. daltland on DSKBBV9HB2PROD with PROPOSALS IV. Statutory and Executive Order Reviews Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA’s role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: • Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011); • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866; • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible VerDate Sep<11>2014 18:44 Mar 21, 2018 Jkt 244001 methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Particulate matter. Authority: 42 U.S.C. 7401 et seq. Dated: March 16, 2018. Anne Idsal, Regional Administrator, Region 6. [FR Doc. 2018–05767 Filed 3–21–18; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket No. CDC–2018–0003; NIOSH–309] RIN 0920–AA66 Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical Amendments Centers for Disease Control and Prevention, HHS. ACTION: Notice of proposed rulemaking. AGENCY: 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: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 1090 SUMMARY: PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 12527 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 https://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 https://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 § 84.310(c), post-approval 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 methods promulgated in §§ 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 §§ 84.303–84.305, nor the environmental conditioning specified in § 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 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 asused (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 reevaluate 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 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 1 77 FR 14168, March 8, 2012. NIOSH National Personal Protective Technology Laboratory Document No. POL– NPPTL–2016–01, https://www.cdc.gov/niosh/npptl/ resources/certpgmspt/pdfs/LTFEpolicyFinalSigned012617.pdf. 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. daltland on DSKBBV9HB2PROD with PROPOSALS 2 See VerDate Sep<11>2014 18:44 Mar 21, 2018 Jkt 244001 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 § 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 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 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-forprofit 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. E:\FR\FM\22MRP1.SGM 22MRP1 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Proposed Rules 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. daltland on DSKBBV9HB2PROD with PROPOSALS 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, VerDate Sep<11>2014 18:44 Mar 21, 2018 Jkt 244001 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 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. 2. Amend § 84.310 by removing paragraph (d), redesignating paragraphs (e)–(g) as (d)–(f), and revising paragraph (c) to read as follows: ■ § 84.310 Post-approval testing. * * * * * (c) NIOSH will conduct such testing pursuant to the methods specified in §§ 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 §§ 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 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 12529 DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 107, 171, 172, 173, 174, 177, 178, 179, and 180 [Docket No. PHMSA–2018–0001; Notice No. 2018–01] Request for Information on Regulatory Challenges to Safely Transporting Hazardous Materials by Surface Modes in an Automated Vehicle Environment Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT). ACTION: Request for information. AGENCY: The Pipeline and Hazardous Materials Safety Administration (PHMSA) requests information on matters related to the development and potential use of automated technologies for surface modes (i.e., highway and rail) in hazardous materials transportation. In anticipation of the development, testing, and integration of Automated Driving Systems in surface transportation, PHMSA is issuing this request for information on the factors the Agency should consider to ensure continued safe transportation of hazardous materials without impeding emerging surface transportation technologies. SUMMARY: Interested persons are invited to submit comments on or before May 7, 2018. Comments received after that date will be considered to the extent practicable. DATES: You may submit comments identified by Docket Number PHMSA– 2018–0001 via any of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting comments. • Fax: 1–202–493–2251. • Mail: Docket Operations, U.S. Department of Transportation, West Building, Ground Floor, Room W12– 140, Routing Symbol M–30, 1200 New Jersey Avenue SE, Washington, DC 20590. • Hand Delivery: To Docket Operations, Room W12–140 on the ground floor of the West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Instructions: All submissions must include the agency name and docket number for this notice. Internet users ADDRESSES: E:\FR\FM\22MRP1.SGM 22MRP1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Proposed Rules]
[Pages 12527-12529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05775]


=======================================================================
-----------------------------------------------------------------------

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: https://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 https://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 https://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\
---------------------------------------------------------------------------

    \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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.