12527 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 PM
2.5, 
NAAQS are implemented in the state. 
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 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 
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 § 84.310(c), post-approval 
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177 FR 14168, March 8, 2012. 
2See NIOSH National Personal Protective 
Technology Laboratory Document No. POL– 
NPPTL–2016–01, https://www.cdc.gov/niosh/npptl/ 
resources/certpgmspt/pdfs/LTFEpolicyFinalSigned- 012617.pdf. 
3Historically, 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. 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,
1NIOSH 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 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 
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 § 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. 
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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 
■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 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 
AGENCY : Pipeline and Hazardous 
Materials Safety Administration (PHMSA), Department of Transportation (DOT). 
ACTION : Request for information. 
SUMMARY : 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. 
DATES : 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. 
ADDRESSES : You may submit comments 
identified by Docket Number PHMSA– 2018–0001 via any of the following methods: 
•Federal eRulemaking Portal: Go to 
http://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 
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