Vol. 84 Tuesday, No. 38 February 26, 2019

Pages 6053–6312

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 84, No. 38

Tuesday, February 26, 2019

Agriculture Department Employment and Training Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6127 Submissions, and Approvals: Petition Requirements and Investigative Data Collection: Civil Rights Commission Trade Act of 1974, as Amended, 6174–6175 NOTICES Meetings: New Hampshire Advisory Committee, 6127–6128 Energy Department See Federal Energy Regulatory Commission PROPOSED RULES Coast Guard Energy Conservation Program: RULES Energy Conservation Standards for Direct Heating Safety Zones: Equipment, 6095–6107 Lower Mississippi River, Mile Markers 93 to 96 Above Test Procedure for Direct Heating Equipment, 6088–6095 Head of Passes, New Orleans, LA, 6080–6081 PROPOSED RULES Special Local Regulations: Environmental Protection Agency Choptank River, Cambridge, MD, 6107–6110 RULES Tolerance Exemption: Commerce Department Waxes and Waxy Substances, Rice Bran, Oxidized, 6081– See Foreign-Trade Zones Board 6084 See International Trade Administration NOTICES See National Institute of Standards and Technology Access to Confidential Business Information: See Patent and Trademark Office Abt Associates Inc., 6142–6143 Agency Information Collection Activities; Proposals, Comptroller of the Currency Submissions, and Approvals: PROPOSED RULES Request for the Greenhouse Gas Reporting Program, Standardized Approach for Calculating the Exposure 6143–6144 Amount of Derivatives Contracts; Extension of Proposed CERCLA Administrative Settlement Agreement Comment Period, 6107 and Order on Consent: City of Kalamazoo, MI, and City of Kalamazoo Corporation for National and Community Service Brownfields Redevelopment Authority; Allied Paper NOTICES Portage Creek/Kalamazoo River Superfund Site, Agency Information Collection Activities; Proposals, Operable Unit 1, Panelyte Property, Kalamazoo MI, Submissions, and Approvals: 6144–6145 Application Package for Grantee Progress Report Data Collection, 6136–6137 Federal Aviation Administration Defense Department RULES NOTICES Airworthiness Directives: Availability for Finding of No Significant Impact for the Airbus SAS Airplanes, 6067–6069 Environmental Assessment Addressing Upgrade of the Dassault Aviation Airplanes, 6059–6062 Main Gate Access Control Point at Defense Distribution Embraer S.A. Airplanes, 6064–6067 Depot, San Joaquin, California, and Surrounding Area, Saab AB, Saab Aeronautics (Formerly Known as Saab AB, 6137–6138 Saab Aerosystems) Airplanes, 6062–6064 NOTICES Charter Renewals: Agency Information Collection Activities; Proposals, Federal Advisory Committees, 6138–6139 Submissions, and Approvals: Meetings: Air Carrier Contract Maintenance Requirements, 6192– Defense Policy Board, 6139–6140 6193 Employee Benefits Security Administration NOTICES Federal Communications Commission Exemptions: RULES UBS Assets Management (Americas) Inc.; UBS Realty Memorializing the Significance of the Chief Information Investors LLC; UBS Hedge Fund Solutions LLC; UBS Officer’s Role, 6085 O’Connor LLC; and Certain Future Affiliates in UBS’s NOTICES Asset Management and Global Wealth Management Agency Information Collection Activities; Proposals, U.S. Divisions (collectively, the Applicants or the Submissions, and Approvals, 6145–6148 UBS QPAMs) Located in Chicago, IL; Hartford, CT; Meetings: New York, NY; and Chicago, IL, Respectively, 6163– Communications Security, Reliability, and 6174 Interoperability Council, 6147

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Federal Deposit Insurance Corporation Prescription Drug-Use-Related Software, 6150 PROPOSED RULES Standardized Approach for Calculating the Exposure Foreign Assets Control Office Amount of Derivatives Contracts; Extension of NOTICES Comment Period, 6107 Blocking or Unblocking of Persons and Properties, 6195– 6196 Federal Energy Regulatory Commission RULES Mergers or Consolidations by a Public Utility, 6069–6076 Foreign-Trade Zones Board NOTICES NOTICES Application: Production Activity: City and County of Denver, CO, 6141–6142 DSM Nutritional Products, LLC, Foreign-Trade Zone 149, Green Mountain Power Corp., 6140 Freeport, TX, 6128–6129 Sparhawk, LLC, 6141 Proposed Production Activity: Designation of Commission Staff as Non-Decisional: GlaxoSmithKline, PLC, Foreign-Trade Zone 93, Raleigh/ Total Gas and Power North America, Aaron Hall and Durham, NC, 6128 Therese Tran, 6142 Subzone Application: Environmental Assessments; Availability, etc.: WPG Americas Inc., Foreign-Trade Zone 262, Southaven, New York Power Authority; Blenheim-Gilboa Pumped MS, 6129 Storage Project, 6140–6141 Subzone Expansions; Application: Meetings: Swagelok Co., Foreign-Trade Zone 40, Cleveland, OH, Mid-America Pipeline Co., LLC, Seminole Pipeline Co., 6129 LLC; Technical Conference, 6140 Government Ethics Office Federal Highway Administration RULES NOTICES Civil Monetary Penalties Inflation Adjustments for Ethics in Final Federal Agency Actions: Government Act Violations, 6053–6055 California; Proposed Highway, 6193–6194

Federal Railroad Administration Health and Human Services Department NOTICES See Food and Drug Administration Petition for Waiver of Compliance, 6194–6195 See National Institutes of Health NOTICES Federal Reserve System Opportunity to Co-Sponsor OMH National Minority Health PROPOSED RULES Month Steps Challenge, 6154–6155 Standardized Approach for Calculating the Exposure Amount of Derivatives Contracts; Extension of Homeland Security Department Comment Period, 6107 See Coast Guard NOTICES See U.S. Customs and Border Protection Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 6148 Interior Department Fish and Wildlife Service See Fish and Wildlife Service RULES See National Park Service Endangered and Threatened Species: Listing the Scarlet Macaw, 6278–6311 Internal Revenue Service PROPOSED RULES RULES Endangered and Threatened Species: Low-Income Housing Credit Compliance-Monitoring Removing the Borax Lake Chub from the List of Regulations, 6076–6080 Endangered and Threatened Wildlife, 6110–6126 NOTICES Agency Information Collection Activities; Proposals, Food and Drug Administration Submissions, and Approvals, 6196–6201 PROPOSED RULES Agency Information Collection Activities; Proposals, Sunscreen Drug Products for Over-the-Counter Human Use, Submissions, and Approvals: 6204–6275 NOTICES Regulation Project, 6200 Agency Information Collection Activities; Proposals, Submissions, and Approvals: International Trade Administration Foreign Supplier Verification Programs for Food NOTICES Importers, 6152–6154 Antidumping or Countervailing Duty Investigations, Orders, Guidance: or Reviews: Assessing the Effects of Food on Drugs in Investigational Corrosion-Resistant Steel Products from Taiwan, 6129– New Drug Applications and New Drug 6131 Applications—Clinical Pharmacology Considerations, Large Residential Washers from the Republic of Korea, 6151–6152 6131–6132 Bioavailability Studies Submitted in New Drug Tapered Roller Bearings and Parts Thereof, Finished and Applications or Investigational New Drug Unfinished, from the People’s Republic of China, Applications—General Considerations, 6148–6150 6132–6134

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International Trade Commission Environmental Impact Statements; Availability, etc.: NOTICES United Nuclear Corporation Church Rock Project; Investigations; Determinations, Modifications, and Rulings, Correction, 6175–6176 etc.: Meetings; Sunshine Act, 6183 Certain Batteries and Electrochemical Devices Containing Composite Separators, Components Thereof, and Patent and Trademark Office Products Containing Same, 6158–6159 NOTICES Agency Information Collection Activities; Proposals, Justice Department Submissions, and Approvals: NOTICES Madrid Protocol, 6135 Agency Information Collection Activities; Proposals, Practitioner Conduct and Discipline, 6136 Submissions, and Approvals, 61591–6163 Agency Information Collection Activities; Proposals, Postal Service Submissions, and Approvals: National Criminal Justice Reference Service Online NOTICES Subscription Center, 6160 Meetings; Sunshine Act, 6183 Proposed Consent Decree: CERCLA, 6163 Securities and Exchange Commission NOTICES Labor Department Application: See Employee Benefits Security Administration Acquirers Funds, LLC, et al., 6184–6186 See Employment and Training Administration Monteagle Funds and Nashville Capital Corp., 6183–6184 NOTICES Toroso Investments, LLC and Tidal ETF Trust, 6186–6188 Meetings: Self-Regulatory Organizations; Proposed Rule Changes: Labor Advisory Committee for Trade Negotiation and NYSE American, LLC, 6188–6190 Trade Policy, 6175 Small Business Administration National Institute of Standards and Technology NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6190 Submissions, and Approvals: Generic Clearance for Community Resilience Data Social Security Administration Collections, 6134–6135 NOTICES National Institutes of Health Agreement on Social Security between the United States and Iceland; Entry into Force, 6190–6191 NOTICES Meetings: National Institute on Alcohol Abuse and Alcoholism, State Department 6155 NOTICES Agency Information Collection Activities; Proposals, National Park Service Submissions, and Approvals: NOTICES Local U.S. Citizen Skills/Resources Survey, 6191 Agency Information Collection Activities; Proposals, Request for Entry into Children’s Passport Issuance Alert Submissions, and Approvals: Program, 6191–6192 National Historic Landmarks Nomination Form, 6157 Using Web and Mobile-Based Applications during Transportation Department National Park Service Citizen Science Events, 6157– See Federal Aviation Administration 6158 See Federal Highway Administration See Federal Railroad Administration National Transportation Safety Board NOTICES NOTICES Meetings: Meetings; Sunshine Act, 6175 Advisory Committee on Human Trafficking, 6195

Nuclear Regulatory Commission Treasury Department RULES See Comptroller of the Currency List of Approved Spent Fuel Storage Casks: See Foreign Assets Control Office Holtec International HI-STORM 100 Cask System, See Internal Revenue Service Certificate of Compliance No. 1014, Amendment No. 13, 6055–6059 PROPOSED RULES U.S. Customs and Border Protection List of Approved Spent Fuel Storage Casks: NOTICES Holtec International HI-STORM 100 Cask System, Agency Information Collection Activities; Proposals, Certificate of Compliance No. 1014, Amendment No. Submissions, and Approvals: 13, 6086–6088 Holders or Containers Which Enter the United States NOTICES Duty Free, 6156–6157 Applications and Amendments to Facility Operating Importers of Merchandise Subject to Actual Use Licenses and Combined Licenses Involving No Provisions, 6155–6156 Significant Hazards Considerations, 6176–6183

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Separate Parts In This Issue Reader Aids Consult the Reader Aids section at the end of this issue for Part II phone numbers, online resources, finding aids, and notice Health and Human Services Department, Food and Drug of recently enacted public laws. Administration, 6204–6275 To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/ Part III accounts/USGPOOFR/subscriber/new, enter your e-mail Interior Department, Fish and Wildlife Service, 6278–6311 address, then follow the instructions to join, leave, or manage your subscription.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

5 CFR 2634...... 6053 2636...... 6053 10 CFR 72...... 6055 Proposed Rules: 72...... 6086 430 (2 documents) ...... 6088, 6095 12 CFR Proposed Rules: 3...... 6107 32...... 6107 217...... 6107 324...... 6107 14 CFR 39 (4 documents) ...6059, 6062, 6064, 6067 18 CFR 33...... 6069 21 CFR Proposed Rules: 201...... 6204 310...... 6204 347...... 6204 352...... 6204 26 CFR 1...... 6076 33 CFR 165...... 6080 Proposed Rules: 100...... 6107 40 CFR 180...... 6081 47 CFR 0...... 6085 50 CFR 17...... 6278 Proposed Rules: 17...... 6110

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Rules and Regulations Federal Register Vol. 84, No. 38

Tuesday, February 26, 2019

This section of the FEDERAL REGISTER The Ethics in Government Act of 1978 Applying the formula established by contains regulatory documents having general as amended, 5 U.S.C. appendix (the the 2015 Act and OMB guidance, OGE applicability and legal effect, most of which Ethics Act) provides for five CMPs.1 is amending the Ethics Act CMPs are keyed to and codified in the Code of Specifically, the Ethics Act provides for through this rulemaking to: Federal Regulations, which is published under penalties that can be assessed by an (1) Increase the three penalties 50 titles pursuant to 44 U.S.C. 1510. appropriate United States district court, reflected in 5 CFR 2634.702(a), 5 CFR The Code of Federal Regulations is sold by based upon a civil action brought by the 2634.703, and 5 CFR 2636.104(a)— the Superintendent of Documents. Department of Justice, for the following which were previously adjusted to a five types of violations: maximum of $19,639—to a maximum of (1) Knowing and willful failure to file, $20,134; OFFICE OF GOVERNMENT ETHICS report required information on, or (2) Increase the penalty reflected in 5 falsification of a public financial CFR 2634.702(b)—which was 5 CFR Parts 2634 and 2636 disclosure report, 5 U.S.C. appendix previously adjusted to a maximum of RIN 3209–AA45 104(a), 5 CFR 2634.701(b); $9,819—to a maximum of $10,067; and (2) knowing and willful breach of a (3) Increase the penalty reflected in 5 2019 Civil Monetary Penalties Inflation qualified trust by trustees and interested CFR 2634.701(b)—which was Adjustments for Ethics in Government parties, 5 U.S.C. appendix previously adjusted to a maximum of Act Violations 102(f)(6)(C)(i), 5 CFR 2634.702(a); $59,028—to a maximum of $60,517. (3) negligent breach of a qualified These adjusted penalty amounts will AGENCY: Office of Government Ethics. trust by trustees and interested parties, apply to penalties assessed after January ACTION: Final rule. 5 U.S.C. appendix 102(f)(6)(C)(ii), 5 CFR 15, 2019 (the applicability date of this 2634.702(b); SUMMARY: final rule) whose associated violations In accordance with the (4) misuse of a public report, 5 U.S.C. Federal Civil Penalties Inflation occurred after November 2, 2015. appendix 105(c)(2), 5 CFR 2634.703; OGE will continue to make future Adjustment Act Improvements Act of and 2015, the U.S. Office of Government annual inflationary adjustments to the (5) violation of outside employment/ Ethics Act CMPs in accordance with the Ethics is issuing this final rule to make activities provisions, 5 U.S.C. appendix the 2019 annual adjustments to the statutory formula set forth in the 2015 504(a), 5 CFR 2636.104(a). Act and OMB guidance. Ethics in Government Act civil In compliance with the 2015 Act and monetary penalties. guidance issued by the Office of II. Matters of Regulatory Procedure DATES: Management and Budget (OMB), the Administrative Procedure Act Effective Date: This final rule is U.S. Office of Government Ethics (OGE) effective February 26, 2019. made previous inflationary adjustments Pursuant to 5 U.S.C. 553(b), as Applicability date: This final rule is to the five Ethics Act CMPs, and is Director of the Office of Government applicable January 15, 2019. issuing this rulemaking to effectuate the Ethics, I find that good cause exists for FOR FURTHER INFORMATION CONTACT: 2019 annual inflationary adjustments to waiving the general notice of proposed Kimberly L. Sikora Panza, Associate those CMPs. In accordance with the rulemaking and public comment Counsel, General Counsel and Legal 2015 Act, these adjustments are based procedures as to these technical Policy Division, Office of Government on the percent change between the amendments. The notice and comment Ethics, Telephone: 202–482–9300; TTY: Consumer Price Index for all Urban procedures are being waived because 800–877–8339; FAX: 202–482–9237. Consumers (CPI–U) for the month of these amendments, which concern SUPPLEMENTARY INFORMATION: October preceding the date of the matters of agency organization, procedure and practice, are being I. Background adjustment, and the prior year’s October CPI–U. Pursuant to OMB guidance, the adopted in accordance with statutorily In November 2015, Congress passed cost-of-living adjustment multiplier for mandated inflation adjustment the Federal Civil Penalties Inflation 2019, based on the CPI–U for October procedures of the 2015 Act, which Adjustment Act Improvements Act of 2018, not seasonally adjusted, is specifies that agencies shall adjust civil 2015 (Sec. 701 of Pub. L. 114–74) (the 1.02522. To calculate the 2019 annual monetary penalties notwithstanding 2015 Act), which further amended the adjustment, agencies must multiply the Section 553 of the Administrative Federal Civil Penalties Inflation most recent penalty by the 1.02522 Procedure Act. It is also in the public Adjustment Act of 1990 (Pub. L. 101– multiplier, and round to the nearest interest that the adjusted rates for civil 410). The 2015 Act required Federal dollar. monetary penalties under the Ethics in agencies to make inflationary Government Act become effective as adjustments to the civil monetary 1 OGE has previously determined, after soon as possible in order to maintain penalties (CMPs) within their consultation with the Department of Justice, that their deterrent effect. jurisdiction with an initial ‘‘catch-up’’ the $200 late filing fee for public financial disclosure reports that are more than 30 days Regulatory Flexibility Act adjustment through an interim final rule overdue (see section 104(d) of the Ethics Act, 5 effective no later than August 1, 2016, U.S.C. appendix, 104(d), and 5 CFR 2634.704 of As the Director of the Office of and further mandates that Federal OGE’s regulations thereunder) is not a CMP as Government Ethics, I certify under the agencies make subsequent annual defined under the Federal Civil Penalties Inflation Regulatory Flexibility Act (5 U.S.C. Adjustment Act, as amended. Therefore, that fee is inflationary adjustments of their CMPs, not being adjusted in this rulemaking (nor was it chapter 6) that this final rule would not to be effective no later than January 15 adjusted by OGE in previous CMP rulemakings), have a significant economic impact on of each year. and will remain at its current amount of $200. a substantial number of small entities

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because it primarily affects current Dated: February 21, 2019. which the action is brought may assess Federal executive branch employees. Emory Rounds, against the individual a civil monetary Director, U.S. Office of Government Ethics. penalty in any amount, not to exceed Paperwork Reduction Act For the reasons set forth in the the amounts set forth in Table 1 to this The Paperwork Reduction Act (44 preamble, the U.S. Office of Government section, as provided by section U.S.C. chapter 35) does not apply Ethics is amending 5 CFR parts 2634 102(f)(6)(C)(i) of the Act and as adjusted because this regulation does not contain and 2636 as follows: in accordance with the inflation information collection requirements that adjustment procedures prescribed in the require approval of the Office of PART 2634—EXECUTIVE BRANCH Federal Civil Penalties Inflation Management and Budget. FINANCIAL DISCLOSURE, QUALIFIED Adjustment Act of 1990, as amended. TRUSTS, AND CERTIFICATES OF Unfunded Mandates Reform Act DIVESTITURE TABLE 1 TO § 2634.702 For purposes of the Unfunded ■ 1. The authority citation for part 2634 Date of violation Penalty Mandates Reform Act of 1995 (2 U.S.C. continues to read as follows: chapter 5, subchapter II), this rule Authority: 5 U.S.C. App.; 26 U.S.C. 1043; Violation occurring between Sept. would not significantly or uniquely Pub. L. 101–410, 104 Stat. 890, 28 U.S.C. 29, 1999 and Nov. 2, 2015 ...... $11,000 affect small governments and will not 2461 note, as amended by Sec. 31001, Pub. Violation occurring after Nov. 2, result in increased expenditures by L. 104–134, 110 Stat. 1321 and Sec. 701, Pub. 2015 ...... 20,134 State, local, and tribal governments, in L. 114–74; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. the aggregate, or by the private sector, of (b) The Attorney General may bring a $100 million or more (as adjusted for 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306. civil action in any appropriate United inflation) in any one year. ■ 2. Section 2634.701 is amended by States district court against any Executive Order 13563 and Executive revising paragraph (b) to read as follows: individual who negligently violates the Order 12866 provisions of § 2634.408(d)(1) or (e)(1). § 2634.701 Failure to file or falsifying The court in which the action is brought Executive Orders 13563 and 12866 reports. may assess against the individual a civil direct agencies to assess all costs and * * * * * monetary penalty in any amount, not to benefits of available regulatory (b) Civil action. The Attorney General exceed the amounts set forth in Table 2 alternatives and, if regulation is may bring a civil action in any to this section, as provided by section appropriate United States district court necessary, to select the regulatory 102(f)(6)(C)(ii) of the Act and as against any individual who knowingly approaches that maximize net benefits adjusted in accordance with the and willfully falsifies or who knowingly (including economic, environmental, inflation adjustment procedures of the public health and safety effects, and willfully fails to file or report any Federal Civil Penalties Inflation distributive impacts, and equity). information required by filers of public Adjustment Act of 1990, as amended. Executive Order 13563 emphasizes the reports under subpart B of this part. The importance of quantifying both costs court in which the action is brought TABLE 2 TO § 2634.702 and benefits, of reducing costs, of may assess against the individual a civil monetary penalty in any amount, not to harmonizing rules, and of promoting Date of violation Penalty flexibility. The Office of Management exceed the amounts set forth in Table 1 to this section, as provided by section and Budget has determined that Violation occurring between Sept. rulemakings such as this implementing 104(a) of the Act, as amended, and as 29, 1999 and Nov. 2, 2015 ...... $5,500 annual inflationary adjustments under adjusted in accordance with the Violation occurring after Nov. 2, the 2015 Act are not significant inflation adjustment procedures 2015 ...... 10,067 regulatory actions under Executive prescribed in the Federal Civil Penalties Order 12866. Inflation Adjustment Act of 1990, as amended. ■ 4. Section 2634.703 is revised to read Executive Order 12988 as follows: TABLE 1 TO § 2634.701 As Director of the Office of § 2634.703 Misuse of public reports. Government Ethics, I have reviewed this Date of violation Penalty (a) The Attorney General may bring a rule in light of section 3 of Executive civil action against any person who Order 12988, Civil Justice Reform, and Violation occurring between Sept. 14, 2007 and Nov. 2, 2015 ...... $50,000 obtains or uses a report filed under this certify that it meets the applicable part for any purpose prohibited by standards provided therein. Violation occurring after Nov. 2, 2015 ...... 60,517 section 105(c)(1) of the Act, as List of Subjects incorporated in § 2634.603(f). The court * * * * * in which the action is brought may 5 CFR Part 2634 ■ 3. Section 2634.702 is revised to read assess against the person a civil Certificates of divestiture, Conflict of as follows: monetary penalty in any amount, not to exceed the amounts set forth in Table 1 interests, Financial disclosure, § 2634.702 Breaches by trust fiduciaries Government employees, Penalties, and interested parties. to this section, as provided by section 105(c)(2) of the Act and as adjusted in Privacy, Reporting and recordkeeping (a) The Attorney General may bring a accordance with the inflation requirements, Trusts and trustees. civil action in any appropriate United adjustment procedures prescribed in the 5 CFR Part 2636 States district court against any individual who knowingly and willfully Federal Civil Penalties Inflation Conflict of interests, Government violates the provisions of Adjustment Act of 1990, as amended. employees, Penalties. § 2634.408(d)(1) or (e)(1). The court in

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TABLE 1 TO § 2634.703 NUCLEAR REGULATORY • Mail comments to: Secretary, U.S. COMMISSION Nuclear Regulatory Commission, Date of violation Penalty Washington, DC 20555–0001, ATTN: 10 CFR Part 72 Rulemakings and Adjudications Staff. Violation occurring between Sept. • [NRC–2019–0030] Hand deliver comments to: 11555 29, 1999 and Nov. 2, 2015 ...... $11,000 Rockville Pike, Rockville, Maryland Violation occurring after Nov. 2, RIN 3150–AK28 20852, between 7:30 a.m. and 4:15 p.m. 2015 ...... 20,134 (Eastern Time) Federal workdays; List of Approved Spent Fuel Storage telephone: 301–415–1677. Casks: Holtec International HI–STORM (b) This remedy shall be in addition For additional direction on obtaining 100 Cask System, Certificate of to any other remedy available under information and submitting comments, Compliance No. 1014, Amendment No. statutory or common law. see ‘‘Obtaining Information and 13 Submitting Comments’’ in the PART 2636—LIMITATIONS ON AGENCY: SUPPLEMENTARY INFORMATION section of OUTSIDE EARNED INCOME, Nuclear Regulatory this document. EMPLOYMENT AND AFFILIATIONS Commission. FOR CERTAIN NONCAREER ACTION: Direct final rule. FOR FURTHER INFORMATION CONTACT: EMPLOYEES Christian Jacobs, Office of Nuclear SUMMARY: The U.S. Nuclear Regulatory Material Safety and Safeguards; Commission (NRC) is amending its telephone: 301–415–6825; email: ■ 5. The authority citation for part 2636 spent fuel storage regulations by [email protected] or Gregory R. continues to read as follows: revising the Holtec International HI– Trussell, Office of Nuclear Material Authority: 5 U.S.C. App. (Ethics in STORM 100 Cask System listing within Safety and Safeguards; telephone: 301– Government Act of 1978); Pub. L. 101–410, the ‘‘List of approved spent fuel storage 415–6244; email: Gregory.Trussell@ 104 Stat. 890, 28 U.S.C. 2461 note (Federal casks’’ to include Amendment No. 13 to nrc.gov. Both are staff of the U.S. Civil Penalties Inflation Adjustment Act of Certificate of Compliance No. 1014. Nuclear Regulatory Commission, 1990), as amended by Sec. 31001, Pub. L. Amendment No. 13 revises Appendix B Washington, DC 20555–0001. 104–134, 110 Stat. 1321 (Debt Collection of the technical specifications to update SUPPLEMENTARY INFORMATION: Improvement Act of 1996) and Sec. 701, Pub. the initial uranium weight for the L. 114–74 (Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015); 16x16B and 16x16C assembly classes to Table of Contents E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., match the value for 16x16A. I. Obtaining Information and Submitting p. 215, as modified by E.O. 12731, 55 FR DATES: This direct final rule is effective Comments 42547, 3 CFR, 1990 Comp., p. 306. May 13, 2019, unless significant adverse II. Rulemaking Procedure comments are received by March 28, III. Background ■ 6. Section 2636.104 is amended by 2019. If this direct final rule is IV. Discussion of Changes revising paragraph (a) to read as follows: withdrawn as a result of such V. Voluntary Consensus Standards VI. Agreement State Compatibility § 2636.104 Civil, disciplinary and other comments, timely notice of the withdrawal will be published in the VII. Plain Writing action. VIII. Environmental Assessment and Finding Federal Register. Comments received (a) Civil action. Except when the of No Significant Environmental Impact after this date will be considered if it is IX. Paperwork Reduction Act Statement employee engages in conduct in good practical to do so, but the NRC is able X. Regulatory Flexibility Certification faith reliance upon an advisory opinion to ensure consideration only for XI. Regulatory Analysis issued under § 2636.103, an employee comments received on or before this XII. Backfitting and Issue Finality who engages in any conduct in violation date. Comments received on this direct XIII. Congressional Review Act of the prohibitions, limitations and final rule will also be considered to be XIV. Availability of Documents restrictions contained in this part may comments on a companion proposed I. Obtaining Information and be subject to civil action under 5 U.S.C. rule published in the Proposed Rules Submitting Comments app. 504(a) and a civil monetary penalty section of this issue of the Federal of not more than the amounts set in Register. A. Obtaining Information Table 1 to this section, as adjusted in ADDRESSES: You may submit comments Please refer to Docket ID NRC–2019– accordance with the inflation 0030 when contacting the NRC about adjustment procedures prescribed in the by any of the following methods: • Federal Rulemaking website: Go to the availability of information for this Federal Civil Penalties Inflation http://www.regulations.gov and search action. You may obtain publicly- Adjustment Act of 1990, as amended, or for Docket ID NRC–2019–0030. Address available information related to this the amount of the compensation the questions about NRC dockets to Carol action by any of the following methods: individual received for the prohibited Gallagher; telephone: 301–415–3463; • Federal Rulemaking website: Go to conduct, whichever is greater. email: [email protected]. For http://www.regulations.gov and search technical questions contact the for Docket ID NRC–2019–0030. TABLE 1 TO § 2636.104 individuals listed in the FOR FURTHER • NRC’s Agencywide Documents Access and Management System Date of violation Penalty INFORMATION CONTACT section of this document. (ADAMS): You may obtain publicly- Violation occurring between Sept. • Email comments to: available documents online in the 29, 1999 and Nov. 2, 2015 ...... $11,000 [email protected]. If you ADAMS Public Documents collection at Violation occurring after Nov. 2, do not receive an automatic email reply http://www.nrc.gov/reading-rm/ 2015 ...... 20,134 confirming receipt, then contact us at adams.html. To begin the search, select 301–415–1677. ‘‘Begin Web-based ADAMS Search.’’ For * * * * * • Fax comments to: Secretary, U.S. problems with ADAMS, please contact [FR Doc. 2019–03288 Filed 2–25–19; 8:45 am] Nuclear Regulatory Commission at 301– the NRC’s Public Document Room (PDR) BILLING CODE 6345–03–P 415–1101. reference staff at 1–800–397–4209, 301–

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415–4737, or by email to pdr.resource@ A significant adverse comment is a CFR) entitled ‘‘General License for nrc.gov. For the convenience of the comment where the commenter Storage of Spent Fuel at Power Reactor reader, instructions about obtaining explains why the rule would be Sites’’ (55 FR 29181; July 18, 1990). This materials referenced in this document inappropriate, including challenges to rule also established a new subpart L in are provided in the ‘‘Availability of the rule’s underlying premise or 10 CFR part 72 entitled ‘‘Approval of Documents’’ section. approach, or would be ineffective or Spent Fuel Storage Casks,’’ which • NRC’s PDR: You may examine and unacceptable without a change. A contains procedures and criteria for purchase copies of public documents at comment is adverse and significant if: obtaining NRC approval of spent fuel the NRC’s PDR, Room O1–F21, One (1) The comment opposes the rule and storage cask designs. The NRC White Flint North, 11555 Rockville provides a reason sufficient to require a subsequently issued a final rule on May Pike, Rockville, Maryland 20852. substantive response in a notice-and- 1, 2000 (65 FR 25241), that approved the B. Submitting Comments comment process. For example, a HI–STORM 100 Cask System design and substantive response is required when: added it to the list of NRC-approved Please include Docket ID NRC–2019– (a) The comment causes the NRC staff cask designs in 10 CFR 72.214 as 0030 in your comment submission. to reevaluate (or reconsider) its position Certificate of Compliance No. 1014. The NRC cautions you not to include or conduct additional analysis; identifying or contact information that (b) The comment raises an issue IV. Discussion of Changes you do not want to be publicly serious enough to warrant a substantive On November 19, 2018, Holtec disclosed in your comment submission. response to clarify or complete the International submitted a request to the The NRC will post all comment record; or NRC to amend Certificate of Compliance submissions at http:// (c) The comment raises a relevant No. 1014 by adding Amendment No. 13. www.regulations.gov as well as enter the issue that was not previously addressed Amendment 13 revises Table 2.1–2: comment submissions into ADAMS. or considered by the NRC staff. Pressurized Water Reactor (PWR) Fuel The NRC does not routinely edit (2) The comment proposes a change Assembly Characteristics of Appendix B comment submissions to remove or an addition to the rule, and it is of the technical specifications to update identifying or contact information. apparent that the rule would be the initial uranium weight for the If you are requesting or aggregating ineffective or unacceptable without 16x16B and 16x16C assembly classes to comments from other persons for incorporation of the change or addition. match the value for 16x16A. submission to the NRC, then you should (3) The comment causes the NRC staff As documented in the preliminary inform those persons not to include to make a change (other than editorial) safety evaluation report, the NRC identifying or contact information that to the rule, Certificate of Compliance, or performed a safety review of the they do not want to be publicly technical specifications. proposed Certificate of Compliance disclosed in their comment submission. For detailed instructions on filing amendment request. Based on its Your request should state that the NRC comments, please see the companion review, the staff determined that there is does not routinely edit comment proposed rule published in the reasonable assurance that: (1) The submissions to remove such information Proposed Rules section of this issue of activities authorized by the amended before making the comment the Federal Register. certificate can be conducted without submissions available to the public or endangering the health and safety of the III. Background entering the comment into ADAMS. public, and (2) these activities will be Section 218(a) of the Nuclear Waste conducted in compliance with the II. Rulemaking Procedure Policy Act of 1982, as amended, applicable regulations of 10 CFR part This direct final rule is limited to the requires that ‘‘[t]he Secretary [of the 72. There are no significant changes to changes contained in Amendment No. Department of Energy] shall establish a cask design requirements in the 13 to Certificate of Compliance No. 1014 demonstration program, in cooperation proposed amendment. Considering the and does not include other aspects of with the private sector, for the dry specific design requirements for each the HI–STORM 100 Cask System design. storage of spent nuclear fuel at civilian accident condition, the design of the The NRC is using the ‘‘direct final rule nuclear power reactor sites, with the cask would prevent loss of containment, procedure’’ to issue this amendment objective of establishing one or more shielding, and criticality control in the because it represents a limited and technologies that the [Nuclear event of an accident. The amendment routine change to an existing certificate Regulatory] Commission may, by rule, does not reflect a significant change in of compliance that is expected to be approve for use at the sites of civilian design or fabrication of the cask. In noncontroversial. Adequate protection nuclear power reactors without, to the addition, any resulting occupational of public health and safety continues to maximum extent practicable, the need exposure or offsite dose rates from the be ensured. The amendment to the rule for additional site-specific approvals by implementation of Amendment No. 13 will become effective on May 13, 2019. the Commission.’’ Section 133 of the would remain well within the 10 CFR However, if the NRC receives significant Nuclear Waste Policy Act states, in part, part 20 limits. There will be no adverse comments on this direct final that ‘‘[the Commission] shall, by rule, significant change in the types or rule by March 28, 2019, then the NRC establish procedures for the licensing of amounts of any effluent released, no will publish a document that withdraws any technology approved by the significant increase in the individual or this action and will subsequently Commission under Section 219(a) [sic: cumulative radiation exposure, and no address the comments received in a 218(a)] for use at the site of any civilian significant increase in the potential for, final rule as a response to the nuclear power reactor.’’ or consequences from, radiological companion proposed rule published in To implement this mandate, the accidents. the Proposed Rules section of this issue Commission approved dry storage of This direct final rule revises the of the Federal Register. Absent spent nuclear fuel in NRC-approved Holtec International HI–STORM 100 significant modifications to the casks under a general license by Cask System listing in 10 CFR 72.214 by proposed revisions requiring publishing a final rule which added a adding Amendment No. 13 to Certificate republication, the NRC will not initiate new subpart K in part 72 of title 10 of of Compliance No. 1014. This a second comment period on this action. the Code of Federal Regulations (10 amendment consists of the changes

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previously described, as set forth in the VII. Plain Writing events and the most severe natural revised certificate of compliance and The Plain Writing Act of 2010 (Pub. phenomena reported for the site and technical specifications. The revised L. 111–274) requires Federal agencies to surrounding area. Postulated accidents technical specifications are identified in write documents in a clear, concise, and analyzed for an independent spent fuel the preliminary safety evaluation report. well-organized manner. The NRC has storage installation, the type of facility at which a holder of a power reactor The amended Holtec International written this document to be consistent operating license would store spent fuel HI–STORM 100 Cask System design, with the Plain Writing Act as well as the Presidential Memorandum, ‘‘Plain in casks in accordance with 10 CFR part when used under the conditions 72, include tornado winds and tornado- specified in the Certificate of Language in Government Writing,’’ published June 10, 1998 (63 FR 31885). generated missiles, a design basis Compliance, technical specifications, earthquake, a design basis flood, an and the NRC’s regulations, will meet the VIII. Environmental Assessment and accidental cask drop, lightning effects, requirements of 10 CFR part 72; Finding of No Significant Impact fire, explosions, and other incidents. therefore, adequate protection of public Considering the specific design A. The Action health and safety will continue to be requirements for each accident ensured. When this direct final rule The action is to amend 10 CFR 72.214 condition, the design of the cask would becomes effective, persons who hold a to revise the Holtec International HI– prevent loss of confinement, shielding, general license under 10 CFR 72.210 STORM 100 Cask System listing within and criticality control in the event of an may load spent nuclear fuel into HI– the ‘‘List of approved spent fuel storage accident. If there is no loss of STORM 100 Cask System casks that casks’’ to include Amendment No. 13 to confinement, shielding, or criticality meet the criteria of Amendment No. 13 Certificate of Compliance No. 1014. control, the environmental impacts to Certificate of Compliance No. 1014 Amendment No. 13 revises Table 2.1–2: resulting from an accident would be under 10 CFR 72.212. PWR Fuel Assembly Characteristics of insignificant. This amendment does not Appendix B of the technical reflect a significant change in design or V. Voluntary Consensus Standards specifications to update the initial fabrication of the cask. uranium weight for the 16x16B and Because there are no significant The National Technology Transfer 16x16C assembly classes to match the design or process changes, any resulting and Advancement Act of 1995 (Pub. L. value for 16x16A. occupational exposure or offsite dose 104–113) requires that Federal agencies rates from the implementation of use technical standards that are B. The Need for the Action Amendment No. 13 would remain well developed or adopted by voluntary This direct final rule adds an within the 10 CFR part 20 limits. consensus standards bodies unless the amended Certificate of Compliance for Therefore, the proposed changes will use of such a standard is inconsistent the Holtec International HI–STORM 100 not result in any radiological or non- with applicable law or otherwise Cask System design to the list of radiological environmental impacts that impractical. In this direct final rule, the approved spent fuel storage casks that significantly differ from the NRC will revise the Holtec International power reactor licensees can use to store environmental impacts evaluated in the HI–STORM 100 Cask System design spent fuel at reactor sites under a environmental assessment supporting listed in 10 CFR 72.214, ‘‘List of general license. Specifically, the July 18, 1990 final rule. There will approved spent fuel storage casks.’’ This Amendment No. 13 revises Table 2.1–2: be no significant change in the types or action does not constitute the PWR Fuel Assembly Characteristics of significant revisions in the amounts of establishment of a standard that Appendix B of the technical any effluent released, no significant contains generally applicable specifications to update the initial increase in the individual or cumulative requirements. uranium weight for the 16x16B and radiation exposure, and no significant 16x16C assembly classes to match the increase in the potential for or VI. Agreement State Compatibility value for 16x16A. consequences from radiological accidents. The staff documented its Under the ‘‘Policy Statement on C. Environmental Impacts of the Action Adequacy and Compatibility of safety findings in the preliminary safety On July 18, 1990 (55 FR 29181), the Agreement State Programs’’ approved by evaluation report. NRC issued an amendment to 10 CFR the Commission on June 30, 1997, and part 72 to provide for the storage of D. Alternative to the Action published in the Federal Register on spent fuel under a general license in The alternative to this action is to September 3, 1997 (62 FR 46517), this cask designs approved by the NRC. The deny approval of Amendment No. 13 rule is classified as Compatibility potential environmental impact of using and end the direct final rule. Category ‘‘NRC.’’ Compatibility is not NRC-approved storage casks was Consequently, any 10 CFR part 72 required for Category ‘‘NRC’’ initially analyzed in the environmental general licensee that seeks to load spent regulations. The NRC program elements assessment for the 1990 final rule. The nuclear fuel into the Holtec in this category are those that relate environmental assessment for International HI–STORM 100 Cask directly to areas of regulation reserved Amendment No. 13 tiers off of the System and utilize the technical to the NRC by the Atomic Energy Act of environmental assessment for the July specifications in accordance with the 1954, as amended, or the provisions of 18, 1990 final rule. Tiering on past changes described in proposed 10 CFR. Although an Agreement State environmental assessments is a standard Amendment No. 13, would have to may not adopt program elements process under the National request an exemption from the reserved to the NRC, and the Category Environmental Policy Act of 1969, as requirements of 10 CFR 72.212 and ‘‘NRC’’ does not confer regulatory amended. 72.214. Under this alternative, authority on the State, the State may The Holtec International HI–STORM interested licensees would have to wish to inform its licensees of certain 100 Cask System is designed to mitigate prepare, and the NRC would have to requirements by means consistent with the effects of design basis accidents that review, a separate exemption request, the particular State’s administrative could occur during storage. Design basis thereby increasing the administrative procedure laws. accidents account for human-induced burden upon the NRC and the costs to

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each licensee. Therefore, the plant licensees and Holtec International. with the NRC’s responsibilities for environmental impacts would be the These entities do not fall within the public health and safety and the same, or more likely greater than, the scope of the definition of small entities common defense and security. No other proposed action. set forth in the Regulatory Flexibility available alternative is believed to be as Act or the size standards established by E. Alternative Use of Resources satisfactory, and therefore, this action is the NRC (10 CFR 2.810). recommended. Approval of Amendment No. 13 to XI. Regulatory Analysis Certificate of Compliance No. 1014 XII. Backfitting and Issue Finality would result in no irreversible On July 18, 1990 (55 FR 29181), the commitment of resources. NRC issued an amendment to 10 CFR The NRC has determined that the part 72 to provide for the storage of backfit rule (10 CFR 72.62) does not F. Agencies and Persons Contacted spent nuclear fuel under a general apply to this direct final rule. Therefore, No agencies or persons outside the license in cask designs approved by the a backfit analysis is not required. This NRC were contacted in connection with NRC. Any nuclear power reactor direct final rule revises Certificate of the preparation of this environmental licensee can use NRC-approved cask Compliance No. 1014 for the Holtec assessment. designs to store spent nuclear fuel if it International HI-STORM 100 Cask notifies the NRC in advance, the spent System, as currently listed in 10 CFR G. Finding of No Significant Impact fuel is stored under the conditions 72.214, ‘‘List of approved spent fuel The environmental impacts of the specified in the cask’s Certificate of storage casks.’’ The revision requests action have been reviewed under the Compliance, and the conditions of the changes to Table 2.1–2: PWR Fuel requirements in the National general license are met. A list of NRC- Assembly Characteristics of Appendix B Environmental Policy Act of 1969, as approved cask designs is contained in of the technical specifications to update amended, and the NRC’s regulations in 10 CFR 72.214. On May 1, 2000 (65 FR the initial uranium weight for the subpart A of 10 CFR part 51, 25241), the NRC issued an amendment 16x16B and 16x16C assembly classes to ‘‘Environmental Protection Regulations to 10 CFR part 72 that approved the HI- match the value for 16x16A. for Domestic Licensing and Related STORM 100 Cask System design by Regulatory Functions.’’ Based on the adding it to the list of NRC-approved Amendment No. 13 to Certificate of foregoing environmental assessment, the cask designs in 10 CFR 72.214. Compliance No. 1014 for the Holtec NRC concludes that this direct final rule On November 19, 2018, Holtec International HI-STORM 100 Cask entitled ‘‘List of Approved Spent Fuel International submitted a request to the System was initiated by Holtec Storage Casks: Holtec International HI– NRC to amend Certificate of Compliance International and was not submitted in STORM 100 Cask System, Certificate of No. 1014 by adding Amendment No. 13. response to new NRC requirements, or Compliance No. 1014, Amendment No. Holtec International submitted this an NRC request for amendment. 13,’’ will not have a significant effect on application to amend the Holtec Amendment No. 13 applies only to new the human environment. Therefore, the International HI-STORM 100 Cask casks fabricated and used under NRC has determined that an System as described in Section IV, Amendment No. 13. These changes do environmental impact statement is not ‘‘Discussion of Changes,’’ of this not affect existing users of the Holtec necessary for this direct final rule. document. International HI-STORM 100 Cask The alternative to this action is to System, and the current Amendment IX. Paperwork Reduction Act withhold approval of Amendment No. Statement No. 12 continues to be effective for 13 and to require any 10 CFR part 72 existing users. While current users of This direct final rule does not contain general licensee seeking to load spent this storage system may comply with any new or amended collections of nuclear fuel into the Holtec the new requirements in Amendment information subject to the Paperwork International HI-STORM 100 Cask No. 13, this would be a voluntary System under the changes described in Reduction Act of 1995 (44 U.S.C. 3501 decision on the part of current users. et seq.). Existing collections of Amendment No. 13 to request an information were approved by the exemption from the requirements of 10 For these reasons, Amendment No. 13 Office of Management and Budget, CFR 72.212 and 72.214. Under this to Certificate of Compliance No. 1014 approval number 3150–0132. alternative, each interested 10 CFR part does not constitute backfitting under 10 72 licensee would have to prepare, and CFR 72.62 or 10 CFR 50.109(a)(1), or Public Protection Notification the NRC would have to review, a otherwise represent an inconsistency The NRC may not conduct or sponsor, separate exemption request, thereby with the issue finality provisions and a person is not required to respond increasing the administrative burden applicable to combined licenses in 10 to, a request for information or an upon the NRC and the costs to each CFR part 52. Accordingly, the NRC staff information collection requirement licensee. has not prepared a backfit analysis for unless the requesting document Approval of this direct final rule is this rulemaking. displays a currently valid Office of consistent with previous NRC actions. Management and Budget control Further, as documented in the XIII. Congressional Review Act preliminary safety evaluation report and number. This direct final rule is not a rule as environmental assessment, this direct defined in the Congressional Review X. Regulatory Flexibility Certification final rule will have no adverse effect on Act. Under the Regulatory Flexibility Act public health and safety or the of 1980 (5 U.S.C. 605(b)), the NRC environment. This direct final rule has XIV. Availability of Documents certifies that this direct final rule will no significant identifiable impact or not, if issued, have a significant benefit on other Government agencies. The documents identified in the economic impact on a substantial Based on this regulatory analysis, the following table are available to number of small entities. This direct NRC concludes that the requirements of interested persons through one or more final rule affects only nuclear power this direct final rule are commensurate of the following methods, as indicated.

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ADAMS Accession No./ Document Web link/Federal Register Citation

Letter from Holtec International dated November 19, 2018, Submitting Request for Amendment No. 13 to Cer- tificate of Compliance No. 1014 ...... ML18325A154 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Certificate of Compliance for Spent Fuel Storage Casks ...... ML18351A173 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix A ...... ML18351A174 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix B ...... ML18351A175 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix A–100U ML18351A176 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix B–100U ML18351A177 Certificate of Compliance No. 1014 Amendment No. 13, Preliminary Safety Evaluation Report ...... ML18351A178

The NRC may post materials related 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 Docket Number: 72–1014. to this document, including public note. Certificate Expiration Date: May 31, comments, on the Federal Rulemaking ■ 2. In § 72.214, Certificate of 2020. website at http://www.regulations.gov Compliance 1014 is revised to read as Model Number: HI-STORM 100. under Docket ID NRC–2019–0030. The follows: * * * * * Federal Rulemaking website allows you Dated at Rockville, Maryland, this 14th day to receive alerts when changes or § 72.214 List of approved spent fuel storage casks. of February, 2019. additions occur in a docket folder. To For the Nuclear Regulatory Commission. subscribe: (1) Navigate to the docket * * * * * Certificate Number: 1014. Margaret M. Doane, folder (NRC–2019–0030); (2) click the Executive Director for Operations. ‘‘Sign up for Email Alerts’’ link; and (3) Initial Certificate Effective Date: May enter your email address and select how 31, 2000. [FR Doc. 2019–02886 Filed 2–25–19; 8:45 am] Amendment Number 1 Effective Date: frequently you would like to receive BILLING CODE 7590–01–P July 15, 2002. emails (daily, weekly, or monthly). Amendment Number 2 Effective Date: List of Subjects in 10 CFR Part 72 June 7, 2005. DEPARTMENT OF TRANSPORTATION Amendment Number 3 Effective Date: Administrative practice and May 29, 2007. Federal Aviation Administration procedure, Hazardous waste, Indians, Amendment Number 4 Effective Date: Intergovernmental relations, Nuclear January 8, 2008. 14 CFR Part 39 energy, Penalties, Radiation protection, Amendment Number 5 Effective Date: Reporting and recordkeeping July 14, 2008. [Docket No. FAA–2018–0643; Product requirements, Security measures, Amendment Number 6 Effective Date: Identifier 2018–NM–084–AD; Amendment Whistleblowing. August 17, 2009. 39–19572; AD 2019–03–20] For the reasons set out in the Amendment Number 7 Effective Date: RIN 2120–AA64 preamble and under the authority of the December 28, 2009. Atomic Energy Act of 1954, as amended; Amendment Number 8 Effective Date: Airworthiness Directives; Dassault the Energy Reorganization Act of 1974, May 2, 2012, as corrected on November Aviation Airplanes as amended; the Nuclear Waste Policy 16, 2012 (ADAMS Accession No. AGENCY: Federal Aviation Act of 1982, as amended; and 5 U.S.C. ML12213A170); superseded by 552 and 553; the NRC is adopting the Administration (FAA), Department of Amendment 8, Revision 1 Effective Transportation (DOT). following amendments to 10 CFR part Date: February 16, 2016. 72: Amendment Number 8, Revision 1 ACTION: Final rule. Effective Date: February 16, 2016. PART 72—LICENSING SUMMARY: We are adopting a new Amendment Number 9 Effective Date: airworthiness directive (AD) for certain REQUIREMENTS FOR THE March 11, 2014, superseded by INDEPENDENT STORAGE OF SPENT Dassault Aviation Model FALCON 7X Amendment Number 9, Revision 1, on airplanes. This AD was prompted by a NUCLEAR FUEL, HIGH-LEVEL March 21, 2016. RADIOACTIVE WASTE, AND determination that new and more Amendment Number 9, Revision 1, restrictive maintenance requirements REACTOR-RELATED GREATER THAN Effective Date: March 21, 2016, as CLASS C WASTE and airworthiness limitations are corrected (ADAMS Accession No. necessary. This AD requires revising the ■ ML17236A451). existing maintenance or inspection 1. The authority citation for part 72 Amendment Number 10 Effective continues to read as follows: program, as applicable, to incorporate Date: May 31, 2016, as corrected new and more restrictive maintenance Authority: Atomic Energy Act of 1954, (ADAMS Accession No. ML17236A452). requirements and airworthiness secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, Amendment Number 11 Effective limitations for airplane structures and 183, 184, 186, 187, 189, 223, 234, 274 (42 Date: February 25, 2019. systems. We are issuing this AD to U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, Amendment Number 12 Effective address the unsafe condition on these 2099, 2111, 2201, 2210e, 2232, 2233, 2234, Date: February 25, 2019. 2236, 2237, 2238, 2273, 2282, 2021); Energy Amendment Number 13 Effective products. Reorganization Act of 1974, secs. 201, 202, DATES: This AD is effective April 2, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Date: May 13, 2019. National Environmental Policy Act of 1969 Safety Analysis Report (SAR) 2019. (42 U.S.C. 4332); Nuclear Waste Policy Act Submitted by: Holtec International. The Director of the Federal Register of 1982, secs. 117(a), 132, 133, 134, 135, 137, SAR Title: Final Safety Analysis approved the incorporation by reference 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), Report for the HI-STORM 100 Cask of a certain publication listed in this AD 10152, 10153, 10154, 10155, 10157, 10161, System. as of April 2, 2019.

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ADDRESSES: For service information November 15, 2018 (83 FR 57364). We • Are consistent with the intent that identified in this final rule, contact issued the SNPRM to require the was proposed in the SNPRM for Dassault Falcon Jet Corporation, incorporation of revised and more addressing the unsafe condition; and Teterboro Airport, P.O. Box 2000, South restrictive airworthiness limitations • Do not add any additional burden Hackensack, NJ 07606; phone: 201–440– than those proposed in the NRPM. upon the public than was already 6700; internet: http:// We are issuing this AD to address proposed in the SNPRM. www.dassaultfalcon.com. You may reduced structural integrity and reduced view this service information at the control of airplanes due to the failure of Related Service Information Under 1 FAA, Transport Standards Branch, 2200 system components. CFR Part 51 South 216th St., Des Moines, WA. For The European Aviation Safety Agency Dassault Aviation has issued Chapter information on the availability of this (EASA), which is the Technical Agent 5–40–00, Airworthiness Limitations, material at the FAA, call 206–231–3195. for the Member States of the European DGT 107838, Revision 7, dated August It is also available on the internet at Union, has issued EASA AD 2018–0101, 24, 2018, of the Dassault Falcon 7X http://www.regulations.gov by searching dated May 3, 2018 (referred to after this Maintenance Manual (MM). This service for and locating Docket No. FAA–2018– as the Mandatory Continuing information introduces new and more 0643. Airworthiness Information, or ‘‘the restrictive maintenance requirements MCAI’’), to correct an unsafe condition Examining the AD Docket and airworthiness limitations for for certain Dassault Aviation Model airplane structures and systems. This You may examine the AD docket on FALCON 7X airplanes. The MCAI service information is reasonably the internet at http:// states: available because the interested parties www.regulations.gov by searching for The airworthiness limitations and have access to it through their normal and locating Docket No. FAA–2018– certification maintenance instructions for course of business or by the means 0643; or in person at Docket Operations Dassault Falcon 7X aeroplanes, which are identified in the ADDRESSES section. between 9 a.m. and 5 p.m., Monday approved by EASA, are currently defined and through Friday, except Federal holidays. published in Dassault Falcon 7X AMM Costs of Compliance The AD docket contains this final rule, [airplane maintenance manual], Chapter 5– We estimate that this AD affects 67 40. These instructions have been identified the regulatory evaluation, any airplanes of U.S. registry. We estimate comments received, and other as mandatory for continued airworthiness. Failure to accomplish these instructions the following costs to comply with this information. The address for Docket could result in an unsafe condition [i.e., AD: Operations (phone: 800–647–5527) is reduced structural integrity and reduced We have determined that revising the U.S. Department of Transportation, control of these airplanes due to the failure existing maintenance or inspection Docket Operations, M–30, West of system components]. program takes an average of 90 work- Building Ground Floor, Room W12–140, Previously, EASA issued AD 2015–0095 hours per operator, although we 1200 New Jersey Avenue SE, [which corresponds to FAA AD 2016–16–09, recognize that this number may vary Washington, DC 20590. Amendment 39–18607 (81 FR 52752, August from operator to operator. In the past, 10, 2016) (‘‘AD 2016–16–09’’)] to require FOR FURTHER INFORMATION CONTACT: Tom accomplishment of the maintenance tasks, we have estimated that this action takes Rodriguez, Aerospace Engineer, and implementation of the airworthiness 1 work-hour per airplane. Since International Section, Transport limitations, as specified in Dassault Falcon operators incorporate maintenance or Standards Branch, FAA, 2200 South 7X AMM, Chapter 5–40, at Revision 4. inspection program changes for their 216th St., Des Moines, WA 98198; Since that [EASA] AD was issued, Dassault affected fleet(s), we have determined phone and fax: 206–231–3226. issued the ALS [airworthiness limitations that a per-operator estimate is more section], which introduces new and more SUPPLEMENTARY INFORMATION: accurate than a per-airplane estimate. restrictive maintenance requirements and/or Therefore, we estimate the total cost per Discussion airworthiness limitations. operator to be $7,650 (90 work-hours × For the reason described above, this We issued a notice of proposed [EASA] AD retains the requirements of EASA $85 per work-hour). rulemaking (NPRM) to amend 14 CFR AD 2015–0095, which is superseded, and Authority for This Rulemaking part 39 by adding an AD that would requires accomplishment of the actions apply to certain Dassault Aviation specified in the ALS. Title 49 of the United States Code Model FALCON 7X airplanes. The You may examine the MCAI in the specifies the FAA’s authority to issue NPRM published in the Federal AD docket on the internet at http:// rules on aviation safety. Subtitle I, Register on August 10, 2018 (83 FR www.regulations.gov by searching for section 106, describes the authority of 39630). The NPRM was prompted by a and locating Docket No. FAA–2018– the FAA Administrator. Subtitle VII: determination that new and more 0643. Aviation Programs, describes in more restrictive maintenance requirements detail the scope of the Agency’s and airworthiness limitations are Comments authority. necessary. The NPRM proposed to We gave the public the opportunity to We are issuing this rulemaking under require revising the existing participate in developing this final rule. the authority described in Subtitle VII, maintenance or inspection program, as We received no comments on the Part A, Subpart III, Section 44701: applicable, to incorporate new and more SNPRM or on the determination of the ‘‘General requirements.’’ Under that restrictive maintenance requirements cost to the public. section, Congress charges the FAA with and airworthiness limitations for promoting safe flight of civil aircraft in airplane structures and systems. Conclusion air commerce by prescribing regulations We issued a supplemental NPRM We reviewed the relevant data and for practices, methods, and procedures (SNPRM) to amend 14 CFR part 39 by determined that air safety and the the Administrator finds necessary for adding an AD that would apply to public interest require adopting this safety in air commerce. This regulation certain Dassault Aviation Model final rule as proposed, except for minor is within the scope of that authority FALCON 7X airplanes. The SNPRM editorial changes. We have determined because it addresses an unsafe condition published in the Federal Register on that these minor changes: that is likely to exist or develop on

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products identified in this rulemaking (a) Effective Date (i) No Alternative Actions, Intervals, and action. This AD is effective April 2, 2019. Critical Design Configuration Control This AD is issued in accordance with Limitations (CDCCLs) authority delegated by the Executive (b) Affected ADs After the maintenance or inspection Director, Aircraft Certification Service, This AD affects AD 2014–16–23, program, as applicable, has been revised as as authorized by FAA Order 8000.51C. Amendment 39–17947 (79 FR 52545, required by paragraph (g) of this AD, no In accordance with that order, issuance September 4, 2014) (‘‘AD 2014–16–23’’) and alternative actions (e.g., inspections), intervals, or CDCCLs may be used unless the of ADs is normally a function of the AD 2016–16–09, Amendment 39–18607 (81 FR 52752, August 10, 2016) (‘‘AD 2016–16– actions, intervals, and CDCCLs are approved Compliance and Airworthiness as an alternative method of compliance 09’’). Division, but during this transition (AMOC) in accordance with the procedures period, the Executive Director has (c) Applicability specified in paragraph (j)(1) of this AD. delegated the authority to issue ADs This AD applies to Dassault Aviation (j) Other FAA AD Provisions applicable to transport category Model FALCON 7X airplanes, certificated in airplanes and associated appliances to The following provisions also apply to this any category, with an original certificate of AD: the Director of the System Oversight airworthiness or original export certificate of (1) Alternative Methods of Compliance Division. airworthiness issued on or before August 24, (AMOCs): The Manager, International Regulatory Findings 2018. Section, Transport Standards Branch, FAA, Note 1 to paragraph (c) of this AD: Model has the authority to approve AMOCs for this This AD will not have federalism AD, if requested using the procedures found FALCON 7X airplanes with modifications implications under Executive Order in 14 CFR 39.19. In accordance with 14 CFR M1000 and M1254 incorporated are 13132. This AD will not have a 39.19, send your request to your principal commonly referred to as ‘‘Model FALCON inspector or local Flight Standards District substantial direct effect on the States, on 8X’’ airplanes as a marketing designation. the relationship between the national Office, as appropriate. If sending information directly to the International Section, send it government and the States, or on the (d) Subject to the attention of the person identified in distribution of power and Air Transport Association (ATA) of paragraph (k)(2) of this AD. Information may responsibilities among the various America Code 05, Time limits/maintenance be emailed to: 9-ANM-116-AMOC- levels of government. checks. [email protected]. Before using any For the reasons discussed above, I approved AMOC, notify your appropriate certify that this AD: (e) Reason principal inspector, or lacking a principal (1) Is not a ‘‘significant regulatory This AD was prompted by a determination inspector, the manager of the local flight action’’ under Executive Order 12866, that new and more restrictive maintenance standards district office/certificate holding (2) Is not a ‘‘significant rule’’ under requirements and airworthiness limitations district office. the DOT Regulatory Policies and are necessary. We are issuing this AD to (2) Contacting the Manufacturer: For any Procedures (44 FR 11034, February 26, address reduced structural integrity and requirement in this AD to obtain corrective actions from a manufacturer, the action must 1979), reduced control of airplanes due to the failure of system components. be accomplished using a method approved (3) Will not affect intrastate aviation by the Manager, International Section, in Alaska, and (f) Compliance Transport Standards Branch, FAA; or the (4) Will not have a significant Comply with this AD within the European Aviation Safety Agency (EASA); or economic impact, positive or negative, Dassault Aviation’s EASA Design compliance times specified, unless already on a substantial number of small entities Organization Approval (DOA). If approved by done. under the criteria of the Regulatory the DOA, the approval must include the Flexibility Act. (g) Revise the Existing Maintenance or DOA-authorized signature. Inspection Program List of Subjects in 14 CFR Part 39 (k) Related Information Within 90 days after the effective date of (1) Refer to Mandatory Continuing Air transportation, Aircraft, Aviation this AD, revise the existing maintenance or Airworthiness Information (MCAI) EASA AD safety, Incorporation by reference, inspection program, as applicable, by 2018–0101, dated May 3, 2018, for related Safety. incorporating the information specified in information. This MCAI may be found in the Chapter 5–40–00, Airworthiness Limitations, Adoption of the Amendment AD docket on the internet at http:// DGT 107838, Revision 7, dated August 24, www.regulations.gov by searching for and Accordingly, under the authority 2018, of the Dassault Falcon 7X Maintenance locating Docket No. FAA–2018–0643. delegated to me by the Administrator, Manual (MM). The initial compliance times (2) For more information about this AD, the FAA amends 14 CFR part 39 as for the tasks specified in Chapter 5–40–00, contact Tom Rodriguez, Aerospace Engineer, follows: Airworthiness Limitations, DGT 107838, International Section, Transport Standards Revision 7, dated August 24, 2018, of the Branch, FAA, 2200 South 216th St., Des PART 39—AIRWORTHINESS Dassault Falcon 7X MM are at the applicable Moines, WA 98198; phone and fax: 206–231– DIRECTIVES compliance times specified in Chapter 5–40– 3226. 00, Airworthiness Limitations, DGT 107838, (l) Material Incorporated by Reference ■ 1. The authority citation for part 39 Revision 7, dated August 24, 2018, of the (1) The Director of the Federal Register continues to read as follows: Dassault Falcon 7X MM, or within 90 days approved the incorporation by reference Authority: 49 U.S.C. 106(g), 40113, 44701. after the effective date of this AD, whichever (IBR) of the service information listed in this occurs later. paragraph under 5 U.S.C. 552(a) and 1 CFR § 39.13 [Amended] (h) Terminating Action for Other ADs part 51. ■ (2) You must use this service information 2. The FAA amends § 39.13 by adding (1) Accomplishing the actions required by the following new airworthiness as applicable to do the actions required by paragraph (g) of this AD terminates the this AD, unless this AD specifies otherwise. directive (AD): requirements of paragraph (q) of AD 2014– (i) Chapter 5–40–00, Airworthiness 2019–03–20 Dassault Aviation: 16–23. Limitations, DGT 107838, Revision 7, dated Amendment 39–19572; Docket No. (2) Accomplishing the actions required by August 24, 2018, of the Dassault Falcon 7X FAA–2018–0643; Product Identifier paragraph (g) of this AD terminates all Maintenance Manual (MM). 2018–NM–084–AD. requirements of AD 2016–16–09. (ii) [Reserved]

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(3) For service information identified in Linko¨ping, Sweden; telephone +46 13 Mandatory Continuing Airworthiness this AD, contact Dassault Falcon Jet 18 5591; fax +46 13 18 4874; email Information, or ‘‘the MCAI’’), to correct Corporation, Teterboro Airport, P.O. Box [email protected]; an unsafe condition for all Saab AB, 2000, South Hackensack, NJ 07606; phone: internet http://www.saabgroup.com. Saab Aeronautics Model SAAB 2000 201–440–6700; internet: http:// www.dassaultfalcon.com. You may view this service information airplanes. The MCAI states: (4) You may view this service information at the FAA, Transport Standards Occurrences were reported that certain fuel at the FAA, Transport Standards Branch, Branch, 2200 South 216th St., Des probes, installed on SAAB 2000 aeroplanes, 2200 South 216th St., Des Moines, WA. For Moines, WA. For information on the indicated misleading fuel quantities on the information on the availability of this availability of this material at the FAA, engine indicating and crew alerting system material at the FAA, call 206–231–3195. call 206–231–3195. It is also available (EICAS). The investigation results suggest (5) You may view this service information on the internet at http:// that this may be an aging phenomenon, that is incorporated by reference at the www.regulations.gov by searching for leading to deteriorated capacity of the fuel National Archives and Records probes. Administration (NARA). For information on and locating Docket No. FAA–2018– This condition, if not detected and the availability of this material at NARA, call 0964. corrected, could lead to incorrect fuel 202–741–6030, or go to: http:// Examining the AD Docket www.archives.gov/federal-register/cfr/ibr- reading, possibly resulting in fuel starvation locations.html. You may examine the AD docket on and uncommanded engine in-flight shut- down, with consequent reduced control of Issued in Des Moines, Washington, on the internet at http:// www.regulations.gov by searching for the aeroplane. February 14, 2019. To address this potential unsafe condition, and locating Docket No. FAA–2018– Michael Kaszycki, SAAB issued the SB [service bulletin] to 0964; or in person at Docket Operations Acting Director, System Oversight Division, provide instructions for a functional check. Aircraft Certification Service. between 9 a.m. and 5 p.m., Monday For the reason described above, this through Friday, except Federal holidays. [FR Doc. 2019–03122 Filed 2–25–19; 8:45 am] [EASA] AD requires a one-time functional The AD docket contains this final rule, check of the fuel quantity system and the fuel BILLING CODE 4910–13–P the regulatory evaluation, any low level EICAS warnings to determine comments received, and other whether any affected parts are out of DEPARTMENT OF TRANSPORTATION information. The address for Docket tolerance and, depending on findings, Operations (phone: 800–647–5527) is replacement of those affected parts. Federal Aviation Administration U.S. Department of Transportation, Docket Operations, M–30, West You may examine the MCAI in the AD docket on the internet at http:// 14 CFR Part 39 Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, www.regulations.gov by searching for [Docket No. FAA–2018–0964; Product Washington, DC 20590. and locating Docket No. FAA–2018– Identifier 2018–NM–127–AD; Amendment 0964. 39–19571; AD 2019–03–19] FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace Comments RIN 2120–AA64 Engineer, International Section, Transport Standards Branch, FAA, 2200 We gave the public the opportunity to Airworthiness Directives; Saab AB, participate in developing this final rule. Saab Aeronautics (Formerly Known as South 216th St., Des Moines, WA 98198; telephone and fax 206–231–3220. We received no comments on the NPRM Saab AB, Saab Aerosystems) or on the determination of the cost to SUPPLEMENTARY INFORMATION: Airplanes the public. Discussion AGENCY: Federal Aviation Clarification of Paragraph (g)(2) of This Administration (FAA), Department of We issued a notice of proposed AD Transportation (DOT). rulemaking (NPRM) to amend 14 CFR ACTION: Final rule. part 39 by adding an AD that would We have removed the words ‘‘has apply to all Saab AB, Saab Aeronautics reached’’ from the definition in SUMMARY: We are adopting a new Model SAAB 2000 airplanes. The NPRM paragraph (g)(2) of this AD for clarity airworthiness directive (AD) for all Saab published in the Federal Register on and to match the MCAI. AB, Saab Aeronautics Model SAAB November 26, 2018 (83 FR 60374). The Conclusion 2000 airplanes. This AD was prompted NPRM was prompted by reports that by reports that certain fuel probes certain fuel probes indicated misleading We reviewed the relevant data and indicated misleading fuel quantities on fuel quantities on the EICAS. The NPRM determined that air safety and the the engine indicating and crew alerting proposed to require a functional check public interest require adopting this system (EICAS). This AD requires a of certain fuel probes, and replacement final rule with the change described functional check of certain fuel probes, with a serviceable part if necessary. previously and minor editorial changes. and replacement with a serviceable part We are issuing this AD to address We have determined that these minor if necessary. We are issuing this AD to deteriorated capacity of the fuel probes, changes: address the unsafe condition on these which could lead to incorrect fuel • products. Are consistent with the intent that reading, possibly resulting in fuel was proposed in the NPRM for DATES: This AD is effective April 2, starvation and uncommanded engine in- addressing the unsafe condition; and 2019. flight shutdown, and consequent • The Director of the Federal Register reduced control of the airplane. Do not add any additional burden approved the incorporation by reference The European Aviation Safety Agency upon the public than was already of a certain publication listed in this AD (EASA), which is the Technical Agent proposed in the NPRM. as of April 2, 2019. for the Member States of the European We also determined that these ADDRESSES: For service information Union, has issued EASA Airworthiness changes will not increase the economic identified in this final rule, contact Saab Directive 2018–0187, dated August 29, burden on any operator or increase the AB, Saab Aeronautics, SE–581 88, 2018 (referred to after this as the scope of this final rule.

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Related Service Information Under 1 accuracy and the low level warning, and Costs of Compliance CFR Part 51 for replacing the affected part with a serviceable part if necessary. We estimate that this AD affects 8 Saab AB, Saab Aeronautics has issued This service information is reasonably airplanes of U.S. registry. We estimate Service Bulletin 2000–28–028, dated available because the interested parties the following costs to comply with this April 19, 2018. This service information have access to it through their normal AD: describes procedures for a functional course of business or by the means check of the fuel indicator gauging identified in the ADDRESSES section.

ESTIMATED COSTS FOR REQUIRED ACTIONS

Cost Labor cost Parts cost Cost per on U.S. product operators

8 work-hours × $85 per hour = $680 ...... $0 $680 $5,440

We estimate the following costs to do applicable to transport category § 39.13 [Amended] any necessary on-condition action that airplanes and associated appliances to ■ 2. The FAA amends § 39.13 by adding would be required based on the results the Director of the System Oversight the following new airworthiness of any required actions. We have no way Division. directive (AD): of determining the number of aircraft Regulatory Findings 2019–03–19 Saab AB, Saab Aeronautics that might need this on-condition (Formerly Known as Saab AB, Saab action: This AD will not have federalism Aerosystems): Amendment 39–19571; implications under Executive Order Docket No. FAA–2018–0964; Product ESTIMATED COSTS OF ON-CONDITION 13132. This AD will not have a Identifier 2018–NM–127–AD. ACTION substantial direct effect on the States, on (a) Effective Date the relationship between the national Parts Cost per This AD is effective April 2, 2019. Labor cost cost product government and the States, or on the distribution of power and (b) Affected ADs 2 work-hours × $85 responsibilities among the various None. per hour = $170 .... $6,295 $6,465 levels of government. (c) Applicability For the reasons discussed above, I This AD applies to all Saab AB, Saab Authority for This Rulemaking certify that this AD: Aeronautics (formerly known as Saab AB, Title 49 of the United States Code Saab Aerosystems) Model SAAB 2000 (1) Is not a ‘‘significant regulatory airplanes, certificated in any category. specifies the FAA’s authority to issue action’’ under Executive Order 12866, rules on aviation safety. Subtitle I, (d) Subject (2) Is not a ‘‘significant rule’’ under section 106, describes the authority of the DOT Regulatory Policies and Air Transport Association (ATA) of the FAA Administrator. Subtitle VII: America Code 28, Fuel. Procedures (44 FR 11034, February 26, Aviation Programs, describes in more 1979), (e) Reason detail the scope of the Agency’s authority. (3) Will not affect intrastate aviation This AD was prompted by reports that in Alaska, and certain fuel probes indicated misleading fuel We are issuing this rulemaking under quantities on the engine indicating and crew the authority described in Subtitle VII, (4) Will not have a significant alerting system (EICAS). We are issuing this Part A, Subpart III, Section 44701: economic impact, positive or negative, AD to address deteriorated capacity of the ‘‘General requirements.’’ Under that on a substantial number of small entities fuel probes, which could lead to incorrect section, Congress charges the FAA with under the criteria of the Regulatory fuel reading, possibly resulting in fuel promoting safe flight of civil aircraft in Flexibility Act. starvation and uncommanded engine in- air commerce by prescribing regulations flight shutdown, and consequent reduced for practices, methods, and procedures List of Subjects in 14 CFR Part 39 control of the airplane. the Administrator finds necessary for Air transportation, Aircraft, Aviation (f) Compliance safety in air commerce. This regulation safety, Incorporation by reference, Comply with this AD within the is within the scope of that authority Safety. compliance times specified, unless already because it addresses an unsafe condition done. that is likely to exist or develop on Adoption of the Amendment (g) Definitions products identified in this rulemaking Accordingly, under the authority (1) An affected part is a fuel probe having action. part number (P/N) 20136–0101, P/N 20136– This AD is issued in accordance with delegated to me by the Administrator, the FAA amends 14 CFR part 39 as 0102, P/N 20136–0103, P/N 20136–0104, P/ authority delegated by the Executive N 20136–0105, or P/N 20136–0106; with fuel Director, Aircraft Certification Service, follows: low level sensors having P/N 20137–0101. as authorized by FAA Order 8000.51C. (2) A serviceable part is an affected part PART 39—AIRWORTHINESS In accordance with that order, issuance that has accumulated less than 1,500 total DIRECTIVES of ADs is normally a function of the flight hours or 12 months since first Compliance and Airworthiness installation on an airplane. ■ Division, but during this transition 1. The authority citation for part 39 (h) Functional Check continues to read as follows: period, the Executive Director has Within 1,500 flight hours or 12 months delegated the authority to issue ADs Authority: 49 U.S.C. 106(g), 40113, 44701. after the effective date of this AD, whichever

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occurs first, accomplish a functional check of paragraph under 5 U.S.C. 552(a) and 1 CFR DATES: This AD is effective April 2, the fuel indicator gauging accuracy and the part 51. 2019. low level warning, in accordance with the (2) You must use this service information The Director of the Federal Register Accomplishment Instructions of Saab Service as applicable to do the actions required by approved the incorporation by reference Bulletin 2000–28–028, dated April 19, 2018. this AD, unless this AD specifies otherwise. (i) Saab Service Bulletin 2000–28–028, of certain publications listed in this AD (i) Corrective Action dated April 19, 2018. as of April 2, 2019. If the functional check required by (ii) [Reserved] ADDRESSES: For service information paragraph (h) of this AD is found to be out (3) For service information identified in identified in this final rule, contact of tolerance, within the limits and under the this AD, contact Saab AB, Saab Aeronautics, Embraer S.A., Technical Publications applicable conditions, as specified in the SE–581 88, Linko¨ping, Sweden; telephone Section (PC 060), Av. Brigadeiro Faria operator’s Minimum Equipment List, replace +46 13 18 5591; fax +46 13 18 4874; email the affected part with a serviceable part, in Lima, 2170—Putim—12227–901 Sa˜o [email protected]; Jose dos Campos—SP—Brazil; accordance with the Accomplishment internet http://www.saabgroup.com. Instructions of Saab Service Bulletin 2000– (4) You may view this service information telephone: +55 12 3927–5852 or +55 12 28–028, dated April 19, 2018. at the FAA, Transport Standards Branch, 3309–0732; fax: +55 12 3927–7546; (j) Parts Installation Limitation 2200 South 216th St., Des Moines, WA. For email: [email protected]; internet: information on the availability of this http://www.flyembraer.com. You may As of the effective date of this AD, no material at the FAA, call 206–231–3195. view this service information at the person may install, on any airplane, an (5) You may view this service information FAA, Transport Standards Branch, 2200 affected part, unless it is a serviceable part, that is incorporated by reference at the as defined in paragraph (g)(2) of this AD. South 216th St., Des Moines, WA. For National Archives and Records information on the availability of this (k) Other FAA AD Provisions Administration (NARA). For information on material at the FAA, call 206–231–3195. the availability of this material at NARA, call The following provisions also apply to this 202–741–6030, or go to: http:// It is also available on the internet at AD: http://www.regulations.gov by searching (1) Alternative Methods of Compliance www.archives.gov/federal-register/cfr/ibr- locations.html. for and locating Docket No. FAA–2018– (AMOCs): The Manager, International 0905. Section, Transport Standards Branch, FAA, Issued in Des Moines, Washington, on has the authority to approve AMOCs for this February 14, 2019. Examining the AD Docket AD, if requested using the procedures found Michael Kaszycki, in 14 CFR 39.19. In accordance with 14 CFR You may examine the AD docket on Acting Director, System Oversight Division, 39.19, send your request to your principal the internet at http:// Aircraft Certification Service. inspector or local Flight Standards District www.regulations.gov by searching for Office, as appropriate. If sending information [FR Doc. 2019–03120 Filed 2–25–19; 8:45 am] and locating Docket No. FAA–2018– directly to the International Section, send it BILLING CODE 4910–13–P 0905; or in person at Docket Operations to the attention of the person identified in between 9 a.m. and 5 p.m., Monday paragraph (l)(2) of this AD. Information may through Friday, except Federal holidays. be emailed to: 9-ANM-116-AMOC- DEPARTMENT OF TRANSPORTATION [email protected]. Before using any The AD docket contains this final rule, approved AMOC, notify your appropriate Federal Aviation Administration the regulatory evaluation, any principal inspector, or lacking a principal comments received, and other inspector, the manager of the local flight 14 CFR Part 39 information. The address for Docket standards district office/certificate holding Operations (phone: 800–647–5527) is district office. [Docket No. FAA–2018–0905; Product U.S. Department of Transportation, (2) Contacting the Manufacturer: For any Identifier 2018–NM–115–AD; Amendment Docket Operations, M–30, West requirement in this AD to obtain corrective 39–19573; AD 2019–03–21] Building Ground Floor, Room W12–140, actions from a manufacturer, the action must be accomplished using a method approved 1200 New Jersey Avenue SE, by the Manager, International Section, RIN 2120–AA64 Washington, DC 20590. Transport Standards Branch, FAA; or the FOR FURTHER INFORMATION CONTACT: Airworthiness Directives; Embraer S.A. European Aviation Safety Agency (EASA); or Krista Greer, Aerospace Engineer, Airplanes Saab AB, Saab Aeronautics’s EASA Design International Section, Transport Organization Approval (DOA). If approved by AGENCY: Standards Branch, FAA, 2200 South the DOA, the approval must include the Federal Aviation DOA-authorized signature. Administration (FAA), Department of 216th St., Des Moines, WA 98198; Transportation (DOT). telephone and fax 206–231–3221. (l) Related Information ACTION: Final rule. SUPPLEMENTARY INFORMATION: (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA SUMMARY: We are adopting a new Discussion Airworthiness Directive 2018–0187, dated airworthiness directive (AD) for all We issued a notice of proposed August 29, 2018, for related information. Embraer S.A. Model ERJ 190–100 STD, rulemaking (NPRM) to amend 14 CFR This MCAI may be found in the AD docket on the internet at http://www.regulations.gov –100 LR, –100 IGW airplanes; and part 39 by adding an AD that would by searching for and locating Docket No. Model ERJ 190–200 STD, –200 LR, and apply to all Embraer S.A. Model ERJ FAA–2018–0964. –200 IGW airplanes. This AD was 190–100 STD, –100 LR, –100 IGW, –200 (2) For more information about this AD, prompted by reports of corrosion and STD, –200 LR, and –200 IGW airplanes. contact Shahram Daneshmandi, Aerospace chromium layer chipping of the forward The NPRM published in the Federal Engineer, International Section, Transport and aft pintle pins of the main landing Register on November 5, 2018 (83 FR Standards Branch, FAA, 2200 South 216th gear (MLG) shock struts. This AD 55297). The NPRM was prompted by St., Des Moines, WA 98198; telephone and requires repetitive inspections for reports of corrosion and chromium layer fax 206–231–3220. discrepancies of affected forward and aft chipping of the forward and aft pintle (m) Material Incorporated by Reference pintle pins of the MLG shock struts, and pins of the MLG shock struts. The (1) The Director of the Federal Register corrective actions if necessary. We are NPRM proposed to require repetitive approved the incorporation by reference issuing this AD to address the unsafe inspections for discrepancies of affected (IBR) of the service information listed in this condition on these products. forward and aft pintle pins of the MLG

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shock struts, and corrective actions if Change Made to This Final Rule • Are consistent with the intent that necessary. We are issuing this AD to was proposed in the NPRM for address discrepancies of affected We have changed this final rule to addressing the unsafe condition; and forward and aft pintle pins of the MLG reference Task 32–11–001–1034, ‘‘Main • Do not add any additional burden shock struts, which could result in the Landing Gear Shock Strut Pintle Pins— upon the public than was already pintle pin shearing under normal load Internal,’’ of the Embraer 190/195 proposed in the NPRM. and consequent collapse of the MLG Maintenance Review Board Report MRB–1928, Revision 12, dated We also determined that these during takeoff or landing. changes will not increase the economic Ageˆncia Nacional de Aviac¸a˜o Civil September 27, 2018. In Revision 12, burden on any operator or increase the (ANAC), which is the aviation authority among other changes, the task interval scope of this final rule. for Brazil, has issued Brazilian is extended from 66 months to 72 Airworthiness Directive 2018–07–01, months resulting from findings of an Related Service Information Under 1 effective July 24, 2018 (referred to after MLG sampling program. CFR Part 51 this as the Mandatory Continuing We have also added Embraer 190/195 Embraer has issued Service Bulletin Airworthiness Information, or ‘‘the Maintenance Review Board Report MCAI’’), to correct an unsafe condition 190–32–0065, Revision 02, dated MRB–1928, Revision 12, dated November 1, 2017. This service for all Embraer S.A. Model ERJ 190–100 September 27, 2018, to paragraphs (i)(1) STD, –100 LR, –100 IGW airplanes; and information describes procedures for and (i)(2) of this AD to give credit for repetitive detailed inspection for Model ERJ 190–200 STD, –200 LR, and inspections that have been done before –200 IGW airplanes. The MCAI states: discrepancies of affected forward and aft the effective date of this AD as specified pintle pins of the left- and right-hand This [Brazilian] AD was prompted by in Task 57–50–007–1247, ‘‘Main MLG shock struts, and repair or reports of corrosion and chromium layer Landing Gear Trunnion Fittings—Inside replacement of any discrepant affected chipping on the rearward and forward Pintle Surfaces—Internal,’’ and Task 32–11– Pin of the Main Landing Gear (MLG) Shock pintle pin. Struts. We are issuing this [Brazilian] AD to 00–001, ‘‘Main Landing Gear (MLG)’’ of Embraer has also issued Task 32–11– detect and correct Pintle Pin[s] having Embraer 190/195 Maintenance Review 001–1034, ‘‘Main Landing Gear Shock [discrepancies including] corrosion or Board Report MRB–1928, Revision 12, Strut Pintle Pins—Internal,’’ of the chromium layer chipping, which could cause dated September 27, 2018. Embraer 190/195 Maintenance Review the Pintle Pin[s] to shear under normal load and lead to collapse of the MLG during take- We have also revised paragraph (i)(3) Board Report MRB–1928, Revision 12, off or landing. of this AD to refer to Task 32–11–001– dated September 27, 2018. This service 1034, ‘‘Main Landing Gear Shock Strut information describes procedures for the Corrective actions include repair or Pintle Pins—Internal,’’ Embraer 190/195 inspection of pintle pins of the MLG replacement of affected forward and aft Maintenance Review Board Report shock struts at areas covered by the pintle pins of the left- and right-hand MRB–1928, Revision 11, dated May 10, MLG shock strut and trunnion. MLG shock struts. You may examine the 2017, and we have redesignated This service information is reasonably MCAI in the AD docket on the internet subsequent paragraphs. at http://www.regulations.gov by available because the interested parties searching for and locating Docket No. Conclusion have access to it through their normal FAA–2018–0905. course of business or by the means We reviewed the relevant data and identified in the ADDRESSES section. Comments determined that air safety and the Costs of Compliance We gave the public the opportunity to public interest require adopting this participate in developing this final rule. final rule with the changes described We estimate that this AD affects 96 We received no comments on the NPRM previously and minor editorial changes. airplanes of U.S. registry. We estimate or on the determination of the cost to We have determined that these minor the following costs to comply with this the public. changes: AD:

ESTIMATED COSTS

Labor cost Parts cost Cost per product Cost on U.S. operators

Up to 22 work-hours × $85 per hour = $0 Up to $1,870 per inspection cycle ...... Up to $179,520 per inspection cycle. Up to $1,870.

We estimate the following costs to do of any required inspection. We have no aircraft that might need these on- any necessary on-condition actions that way of determining the number of condition actions: would be required based on the results

ESTIMATED COSTS OF ON-CONDITION ACTIONS

Labor cost Parts cost Cost per product

6 work-hours × $85 per hour = $510 per MLG (replacement) ...... $1,750 per MLG ...... $2,260 per MLG 6 work-hours × $85 per hour = $510 per MLG (repair) ...... $0 ...... $510 per MLG.

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Authority for This Rulemaking Adoption of the Amendment cycles since new: Within 750 flight cycles after the effective date of this AD. Title 49 of the United States Code Accordingly, under the authority specifies the FAA’s authority to issue delegated to me by the Administrator, (h) Corrective Actions rules on aviation safety. Subtitle I, the FAA amends 14 CFR part 39 as If any discrepancy of any pintle pin is section 106, describes the authority of follows: found during any inspection required by the FAA Administrator. Subtitle VII: paragraph (g) of this AD: Before further flight, Aviation Programs, describes in more PART 39—AIRWORTHINESS repair the affected pintle pin or replace it detail the scope of the Agency’s DIRECTIVES with a new pintle pin, as applicable, in authority. accordance with the Accomplishment We are issuing this rulemaking under ■ 1. The authority citation for part 39 Instructions of Embraer Service Bulletin 190– continues to read as follows: 32–0065, Revision 02, dated November 1, the authority described in Subtitle VII, 2017. Part A, Subpart III, Section 44701: Authority: 49 U.S.C. 106(g), 40113, 44701. ‘‘General requirements.’’ Under that (i) Credit for Previous Actions section, Congress charges the FAA with § 39.13 [Amended] This paragraph provides credit for the promoting safe flight of civil aircraft in ■ 2. The FAA amends § 39.13 by adding initial inspection required by paragraph (g) of air commerce by prescribing regulations the following new airworthiness this AD, if that inspection was performed for practices, methods, and procedures before the effective date of this AD using the directive (AD): applicable service information identified in the Administrator finds necessary for 2019–03–21 Embraer S.A.: Amendment 39– paragraphs (i)(1) through (i)(6) of this AD. safety in air commerce. This regulation 19573; Docket No. FAA–2018–0905; (1) Task 57–50–007–1247, ‘‘Main Landing is within the scope of that authority Product Identifier 2018–NM–115–AD. Gear Trunnion Fittings—Inside Surfaces— because it addresses an unsafe condition Internal,’’ Embraer 190/195 Maintenance that is likely to exist or develop on (a) Effective Date Review Board Report MRB–1928, Revision products identified in this rulemaking This AD is effective April 2, 2019. 11, dated May 10, 2017; or Revision 12, dated September 27, 2018. action. (b) Affected ADs This AD is issued in accordance with (2) Task 32–11–00–001, ‘‘Main Landing None. authority delegated by the Executive Gear (MLG),’’ Embraer 190/195 Maintenance (c) Applicability Review Board Report MRB–1928, Revision Director, Aircraft Certification Service, 11, dated May 10, 2017; or Revision 12, dated as authorized by FAA Order 8000.51C. This AD applies to Embraer S.A. Model September 27, 2018. In accordance with that order, issuance ERJ 190–100 STD, –100 LR, and –100 IGW (3) Task 32–11–001–1034, ‘‘Main Landing of ADs is normally a function of the airplanes; and Model ERJ 190–200 STD, –200 Gear Shock Strut Pintle Pins—Internal,’’ Compliance and Airworthiness LR, and –200 IGW airplanes; certificated in Embraer 190/195 Maintenance Review Board Division, but during this transition any category; all serial numbers. Report MRB–1928, Revision 11, dated May period, the Executive Director has (d) Subject 10, 2017. delegated the authority to issue ADs (4) Embraer Service Bulletin 190–32–0002, Air Transport Association (ATA) of Revision 01, dated November 8, 2012. applicable to transport category America Code 32, Landing Gear. (5) Embraer Service Bulletin 190–32–0065, airplanes and associated appliances to (e) Reason dated August 31, 2016. the Director of the System Oversight (6) Embraer Service Bulletin 190–32–0065, Division. This AD was prompted by reports of Revision 01, dated October 24, 2017. corrosion and chromium layer chipping of Regulatory Findings the forward and aft pintle pins of the main (j) Equivalent Inspection This AD will not have federalism landing gear (MLG) shock struts. We are Performing a detailed inspection for implications under Executive Order issuing this AD to address discrepancies of discrepancies of affected forward and aft affected forward and aft pintle pins of the 13132. This AD will not have a pintle pins of the left- and right-hand MLG MLG shock struts, which could result in the shock struts, in accordance with Task 32–11– substantial direct effect on the States, on pintle pin shearing under normal load and 001–1034, ‘‘Main Landing Gear Shock Strut the relationship between the national consequent collapse of the MLG during Pintle Pins—Internal,’’ of the Embraer 190/ government and the States, or on the takeoff or landing. 195 Maintenance Review Board Report MRB– distribution of power and 1928, Revision 12, dated September 27, 2018, (f) Compliance responsibilities among the various at intervals not to exceed 72 months, is levels of government. Comply with this AD within the equivalent to an inspection required by For the reasons discussed above, I compliance times specified, unless already paragraph (g) of this AD. done. certify that this AD: (k) Other FAA AD Provisions (1) Is not a ‘‘significant regulatory (g) Repetitive Inspections The following provisions also apply to this action’’ under Executive Order 12866, At the applicable time specified in AD: (2) Is not a ‘‘significant rule’’ under paragraph (g)(1) or (g)(2) of this AD: Do a (1) Alternative Methods of Compliance the DOT Regulatory Policies and detailed inspection for discrepancies of (AMOCs): The Manager, International Procedures (44 FR 11034, February 26, affected forward and aft pintle pins of the Section, Transport Standards Branch, FAA, 1979), left- and right-hand MLG shock struts, in has the authority to approve AMOCs for this (3) Will not affect intrastate aviation accordance with the Accomplishment AD, if requested using the procedures found in Alaska, and Instructions of Embraer Service Bulletin 190– in 14 CFR 39.19. In accordance with 14 CFR (4) Will not have a significant 32–0065, Revision 02, dated November 1, 39.19, send your request to your principal economic impact, positive or negative, 2017. Repeat the inspection thereafter at inspector or local Flight Standards District on a substantial number of small entities intervals not to exceed 72 months. Office, as appropriate. If sending information (1) For airplanes on which any MLG pintle directly to the International Section, send it under the criteria of the Regulatory pin having part number (P/N) 2821–0067 or to the attention of the person identified in Flexibility Act. 2821–0025 has accumulated fewer than paragraph (l)(2) of this AD. Information may List of Subjects in 14 CFR Part 39 17,000 total flight cycles since new: Before be emailed to: 9-ANM-116-AMOC- the accumulation of 17,750 total flight cycles. [email protected]. Before using any Air transportation, Aircraft, Aviation (2) For airplanes on which any MLG pintle approved AMOC, notify your appropriate safety, Incorporation by reference, pin having P/N 2821–0067 or 2821–0025 has principal inspector, or lacking a principal Safety. accumulated 17,000 or more total flight inspector, the manager of the local flight

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standards district office/certificate holding 2200 South 216th St., Des Moines, WA. For material at the FAA, call 206–231–3195. district office. information on the availability of this It is also available on the internet at (2) Contacting the Manufacturer: For any material at the FAA, call 206–231–3195. http://www.regulations.gov by searching requirement in this AD to obtain corrective (5) You may view this service information for and locating Docket No. FAA–2018– actions from a manufacturer, the action must that is incorporated by reference at the be accomplished using a method approved National Archives and Records 0962. by the Manager, International Section, Administration (NARA). For information on Examining the AD Docket Transport Standards Branch, FAA; or the the availability of this material at NARA, call Ageˆncia Nacional de Aviac¸a˜o Civil (ANAC); 202–741–6030, or go to: http:// You may examine the AD docket on or ANAC’s authorized Designee. If approved www.archives.gov/federal-register/cfr/ibr- the internet at http:// by the ANAC Designee, the approval must locations.html. www.regulations.gov by searching for include the Designee’s authorized signature. Issued in Des Moines, Washington, on and locating Docket No. FAA–2018– (3) Required for Compliance (RC): If any February 14, 2019. 0962; or in person at Docket Operations service information contains procedures or between 9 a.m. and 5 p.m., Monday tests that are identified as RC, those Michael Kaszycki, procedures and tests must be done to comply Acting Director, System Oversight Division, through Friday, except Federal holidays. with this AD; any procedures or tests that are Aircraft Certification Service. The AD docket contains this final rule, not identified as RC are recommended. Those [FR Doc. 2019–03127 Filed 2–25–19; 8:45 am] the regulatory evaluation, any procedures and tests that are not identified BILLING CODE 4910–13–P comments received, and other as RC may be deviated from using accepted information. The address for Docket methods in accordance with the operator’s Operations (phone: 800–647–5527) is maintenance or inspection program without DEPARTMENT OF TRANSPORTATION U.S. Department of Transportation, obtaining approval of an AMOC, provided Docket Operations, M–30, West the procedures and tests identified as RC can Federal Aviation Administration Building Ground Floor, Room W12–140, be done and the airplane can be put back in an airworthy condition. Any substitutions or 1200 New Jersey Avenue SE, changes to procedures or tests identified as 14 CFR Part 39 Washington, DC 20590. RC require approval of an AMOC. [Docket No. FAA–2018–0962; Product FOR FURTHER INFORMATION CONTACT: (l) Related Information Identifier 2018–NM–125–AD; Amendment Kathleen Arrigotti, Aerospace Engineer, 39–19560; AD 2019–03–08] (1) Refer to Mandatory Continuing International Section, Transport Airworthiness Information (MCAI) Brazilian RIN 2120–AA64 Standards Branch, FAA, 2200 South Airworthiness Directive 2018–07–01, 216th St., Des Moines, WA 98198; effective July 24, 2018, for related Airworthiness Directives; Airbus SAS telephone and fax 206–231–3218. information. This MCAI may be found in the Airplanes SUPPLEMENTARY INFORMATION: AD docket on the internet at http:// www.regulations.gov by searching for and AGENCY: Federal Aviation Discussion locating Docket No. FAA–2018–0905. Administration (FAA), Department of (2) For more information about this AD, Transportation (DOT). We issued a notice of proposed contact Krista Greer, Aerospace Engineer, ACTION: Final rule. rulemaking (NPRM) to amend 14 CFR International Section, Transport Standards part 39 by adding an AD that would Branch, FAA, 2200 South 216th St., Des SUMMARY: We are adopting a new apply to all Airbus SAS Model A350– Moines, WA 98198; telephone and fax 206– airworthiness directive (AD) for all 941 airplanes. The NPRM published in 231–3221. Airbus SAS Model A350–941 airplanes. the Federal Register on November 23, (3) Service information identified in this AD that is not incorporated by reference is This AD was prompted by reports of an 2018 (83 FR 59328). The NPRM was available at the addresses specified in overheat failure mode of the hydraulic prompted by reports of an overheat paragraphs (m)(3) and (m)(4) of this AD. engine-driven pump (EDP), and a failure mode of the hydraulic EDP, and determination that the affected EDP a determination that the affected EDP (m) Material Incorporated by Reference needs to be replaced with an improved needs to be replaced with an improved (1) The Director of the Federal Register EDP. This AD requires replacement of a EDP. The NPRM proposed to require approved the incorporation by reference certain EDP with an improved EDP. We replacement of a certain EDP with an (IBR) of the service information listed in this are issuing this AD to address the unsafe improved EDP. paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. condition on these products. We are issuing this AD to address the (2) You must use this service information DATES: This AD is effective April 2, overheat failure mode of the hydraulic as applicable to do the actions required by 2019. EDP, which may cause a fast this AD, unless this AD specifies otherwise. The Director of the Federal Register temperature rise of the hydraulic fluid, (i) Embraer Service Bulletin 190–32–0065, approved the incorporation by reference and, if combined with an inoperative Revision 02, dated November 1, 2017. of a certain publication listed in this AD fuel tank inerting system, could lead to (ii) Task 32–11–001–1034, ‘‘Main Landing as of April 2, 2019. an uncontrolled overheat of the Gear Shock Strut Pintle Pins—Internal,’’ of hydraulic fluid, possibly resulting in the Embraer 190/195 Maintenance Review ADDRESSES: For service information Board Report MRB–1928, Revision 12, dated identified in this final rule, contact ignition of the fuel-air mixture of the September 27, 2018. Airbus SAS, Airworthiness Office— affected fuel tank. (3) For service information identified in EAL, Rond-Point Emile Dewoitine No: The European Aviation Safety Agency this AD, contact Embraer S.A., Technical 2, 31700 Blagnac Cedex, France; (EASA), which is the Technical Agent Publications Section (PC 060), Av. Brigadeiro telephone +33 5 61 93 36 96; fax +33 5 for the Member States of the European Faria Lima, 2170—Putim—12227–901 Sa˜o 61 93 45 80; email continued- Union, has issued EASA AD 2018–0178, Jose dos Campos—SP—Brazil; telephone: +55 [email protected]; dated August 23, 2018 (referred to after 12 3927–5852 or +55 12 3309–0732; fax: +55 12 3927–7546; email: distrib@ internet http://www.airbus.com. You this as the Mandatory Continuing embraer.com.br; internet: http:// may view this service information at the Airworthiness Information, or ‘‘the www.flyembraer.com. FAA, Transport Standards Branch, 2200 MCAI’’), to correct an unsafe condition (4) You may view this service information South 216th St., Des Moines, WA. For for all Airbus SAS Model A350–941 at the FAA, Transport Standards Branch, information on the availability of this airplanes. The MCAI states:

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In the Airbus A350 design, the hydraulic in service through Airbus SB [service Conclusion fluid cooling system is located in the fuel bulletin] A350–29–P012. Consequently, tanks. Recently, an overheat failure mode of EASA issued AD 2017–0200 [which We reviewed the relevant data, the hydraulic EDP was found, which may corresponds to FAA AD 2018–19–19, considered the comment received, and cause a fast temperature rise of the hydraulic Amendment 39–19419 (83 FR 48203, determined that air safety and the fluid. September 24, 2018)], retaining the public interest require adopting this This condition, if not detected and requirements of EASA AD 2017–0180, which corrected, combined with an inoperative fuel was superseded, and requiring modification final rule as proposed, except for minor tank inerting system, could lead to an of the aeroplane by installing HMCA SW editorial changes. We have determined uncontrolled overheat of the hydraulic fluid, S4.2. that these minor changes: possibly resulting in ignition of the fuel-air Since EASA AD 2017–0200 was issued, it • Are consistent with the intent that mixture in the affected fuel tank. was determined that the affected part need to was proposed in the NPRM for To address this potential unsafe condition, be replaced with improved EDP. Airbus issued a Major Event Revision (MER) Consequently, Airbus issued the SB [Service addressing the unsafe condition; and of the A350 Master Minimum Equipment List Bulletin A350–29–P013, dated March 12, • Do not add any additional burden (MMEL) that incorporates restrictions to 2018] to provide instructions to replace the upon the public than was already avoid an uncontrolled overheat of the affected parts with improved EDP, having P/ proposed in the NPRM. hydraulic system. Consequently, EASA N [part number] 53098–06, which are issued Emergency AD 2017–0154–E to embodied in production through Airbus mod Related Service Information Under 1 require implementation of these dispatch 112192. CFR Part 51 restrictions. For the reasons described above, this After EASA AD 2017–0154–E was issued, [EASA] AD retains the requirement of EASA Airbus has issued Service Bulletin following further investigation, Airbus issued AD 2017–0200, which is superseded, and A350–29–P013, dated March 12, 2018. another MER of the A350 MMEL that requires replacement of each affected parts This service information describes expanded the number of restricted MMEL with improved EDP. items. At the same time, Airbus revised procedures for replacing a certain EDP Flight Operation Transmission (FOT) You may examine the MCAI in the with an improved EDP. AD docket on the internet at http:// 999.0068/17, to inform all operators This service information is reasonably www.regulations.gov by searching for accordingly. Consequently, EASA issued AD available because the interested parties 2017–0180, retaining the requirements of and locating Docket No. FAA–2018– have access to it through their normal EASA Emergency AD 2017–0154–E, which 0962. was superseded, and requiring course of business or by the means implementation of the new Airbus A350 Comments identified in the ADDRESSES section. MMEL MER and, consequently, restrictions We gave the public the opportunity to Costs of Compliance for aeroplane dispatch. participate in developing this final rule. After EASA AD 2017–0180 was issued, Airbus developed HMCA [Hydraulic We have considered the comment We estimate that this AD affects 11 Monitoring and Control Application] SW received. Air Line Pilots Association, airplanes of U.S. registry. We estimate [software] S4.2, embodied in production International stated that it supports the the following costs to comply with this through Airbus mod 112090, and introduced NPRM. AD:

ESTIMATED COSTS FOR REQUIRED ACTIONS

Cost on U.S. Labor cost Parts cost Cost per product operators

Up to 25 work-hours × $85 per Up to $224,400 ...... Up to $226,525 ...... Up to $2,491,775. hour = $2,125.

According to the manufacturer, some promoting safe flight of civil aircraft in the Director of the System Oversight or all of the costs of this AD may be air commerce by prescribing regulations Division. covered under warranty, thereby for practices, methods, and procedures Regulatory Findings reducing the cost impact on affected the Administrator finds necessary for individuals. We do not control warranty safety in air commerce. This regulation This AD will not have federalism coverage for affected individuals. As a is within the scope of that authority implications under Executive Order result, we have included all known because it addresses an unsafe condition 13132. This AD will not have a costs in our cost estimate. that is likely to exist or develop on substantial direct effect on the States, on the relationship between the national Authority for This Rulemaking products identified in this rulemaking action. government and the States, or on the Title 49 of the United States Code distribution of power and This AD is issued in accordance with specifies the FAA’s authority to issue responsibilities among the various authority delegated by the Executive rules on aviation safety. Subtitle I, levels of government. section 106, describes the authority of Director, Aircraft Certification Service, For the reasons discussed above, I the FAA Administrator. Subtitle VII: as authorized by FAA Order 8000.51C. certify that this AD: Aviation Programs, describes in more In accordance with that order, issuance (1) Is not a ‘‘significant regulatory detail the scope of the Agency’s of ADs is normally a function of the action’’ under Executive Order 12866, authority. Compliance and Airworthiness (2) Is not a ‘‘significant rule’’ under Division, but during this transition We are issuing this rulemaking under the DOT Regulatory Policies and period, the Executive Director has the authority described in Subtitle VII, Procedures (44 FR 11034, February 26, Part A, Subpart III, Section 44701: delegated the authority to issue ADs 1979), ‘‘General requirements.’’ Under that applicable to transport category (3) Will not affect intrastate aviation section, Congress charges the FAA with airplanes and associated appliances to in Alaska, and

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(4) Will not have a significant Instructions of Airbus Service Bulletin A350– (2) For more information about this AD, economic impact, positive or negative, 29–P013, dated March 12, 2018. contact Kathleen Arrigotti, Aerospace Engineer, International Section, Transport on a substantial number of small entities (h) Parts Installation Prohibition under the criteria of the Regulatory Standards Branch, FAA, 2200 South 216th At the applicable time specified in St., Des Moines, WA 98198; telephone and Flexibility Act. paragraph (h)(1) or (h)(2) of this AD: No fax 206–231–3218. List of Subjects in 14 CFR Part 39 person may install an EDP having P/N 53098–04 on any airplane. (k) Material Incorporated by Reference Air transportation, Aircraft, Aviation (1) For airplanes that, as of the effective (1) The Director of the Federal Register safety, Incorporation by reference, date of this AD, have any EDP having P/N approved the incorporation by reference Safety. 53098–04 installed: After modification of the (IBR) of the service information listed in this airplane as specified by paragraph (g) of this paragraph under 5 U.S.C. 552(a) and 1 CFR Adoption of the Amendment AD. part 51. (2) For airplanes that, as of the effective (2) You must use this service information Accordingly, under the authority date of this AD, are post-Modification 112192 as applicable to do the actions required by delegated to me by the Administrator, and do not have any EDP having P/N 53098– this AD, unless this AD specifies otherwise. the FAA amends 14 CFR part 39 as 04 installed: As of the effective date of this (i) Airbus Service Bulletin A350–29–P013, follows: AD. dated March 12, 2018. (i) Other FAA AD Provisions (ii) [Reserved] PART 39—AIRWORTHINESS (3) For service information identified in DIRECTIVES The following provisions also apply to this this AD, contact Airbus SAS, Airworthiness AD: Office—EAL, Rond-Point Emile Dewoitine ■ 1. The authority citation for part 39 (1) Alternative Methods of Compliance No: 2, 31700 Blagnac Cedex, France; (AMOCs): The Manager, International continues to read as follows: telephone +33 5 61 93 36 96; fax +33 5 61 Section, Transport Standards Branch, FAA, 93 45 80; email continued- Authority: 49 U.S.C. 106(g), 40113, 44701. has the authority to approve AMOCs for this [email protected]; internet AD, if requested using the procedures found http://www.airbus.com. § 39.13 [Amended] in 14 CFR 39.19. In accordance with 14 CFR (4) You may view this service information 39.19, send your request to your principal ■ 2. The FAA amends § 39.13 by adding at the FAA, Transport Standards Branch, inspector or local Flight Standards District 2200 South 216th St., Des Moines, WA. For the following new airworthiness Office, as appropriate. If sending information information on the availability of this directive (AD): directly to the International Section, send it material at the FAA, call 206–231–3195. to the attention of the person identified in 2019–03–08 Airbus SAS: Amendment 39– (5) You may view this service information paragraph (j)(2) of this AD. Information may 19560; Docket No. FAA–2018–0962; that is incorporated by reference at the be emailed to: 9-ANM-116-AMOC- Product Identifier 2018–NM–125–AD. National Archives and Records [email protected]. Before using any Administration (NARA). For information on (a) Effective Date approved AMOC, notify your appropriate the availability of this material at NARA, call This AD is effective April 2, 2019. principal inspector, or lacking a principal inspector, the manager of the local flight 202–741–6030, or go to: http:// (b) Affected ADs standards district office/certificate holding www.archives.gov/federal-register/cfr/ibr- locations.html. None. district office. (2) Contacting the Manufacturer: For any Issued in Des Moines, Washington, on (c) Applicability requirement in this AD to obtain corrective February 8, 2019. This AD applies to Airbus SAS Model actions from a manufacturer, the action must Michael Kaszycki, A350–941 airplanes, certificated in any be accomplished using a method approved Acting Director, System Oversight Division, category, all serial numbers. by the Manager, International Section, Aircraft Certification Service. Transport Standards Branch, FAA; or the (d) Subject European Aviation Safety Agency (EASA); or [FR Doc. 2019–03125 Filed 2–25–19; 8:45 am] Air Transport Association (ATA) of Airbus SAS’s EASA Design Organization BILLING CODE 4910–13–P America Code 29, Hydraulic power. Approval (DOA). If approved by the DOA, the approval must include the DOA- (e) Reason authorized signature. DEPARTMENT OF ENERGY This AD was prompted by reports of an (3) Required for Compliance (RC): If any overheat failure mode of the hydraulic service information contains procedures or Federal Energy Regulatory engine-driven pump (EDP), and a tests that are identified as RC, those determination that the affected EDP needs to procedures and tests must be done to comply Commission be replaced with an improved EDP. We are with this AD; any procedures or tests that are issuing this AD to address the overheat not identified as RC are recommended. Those 18 CFR Part 33 failure mode of the hydraulic EDP, which procedures and tests that are not identified [Docket No. RM19–4–000; Order No. 855] may cause a fast temperature rise of the as RC may be deviated from using accepted hydraulic fluid, and, if combined with an methods in accordance with the operator’s Mergers or Consolidations by a Public inoperative fuel tank inerting system, could maintenance or inspection program without lead to an uncontrolled overheat of the obtaining approval of an AMOC, provided Utility hydraulic fluid, possibly resulting in ignition the procedures and tests identified as RC can AGENCY: Federal Energy Regulatory of the fuel-air mixture of the affected fuel be done and the airplane can be put back in tank. an airworthy condition. Any substitutions or Commission, Department of Energy. changes to procedures or tests identified as ACTION: Final rule. (f) Compliance RC require approval of an AMOC. Comply with this AD within the SUMMARY: Pursuant to ‘‘An Act to amend compliance times specified, unless already (j) Related Information section 203 of the Federal Power Act’’ done. (1) Refer to Mandatory Continuing (Act), the Federal Energy Regulatory Airworthiness Information (MCAI) EASA AD (g) Required Action Commission (Commission) revises its 2018–0178, dated August 23, 2018, for regulations relating to mergers or Before February 6, 2020, replace each EDP related information. This MCAI may be having part number (P/N) 53098–04 with an found in the AD docket on the internet at consolidations by a public utility. improved EDP, having P/N 53098–06, in http://www.regulations.gov by searching for DATES: This rule will become effective accordance with the Accomplishment and locating Docket No. FAA–2018–0962. March 27, 2019.

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FOR FURTHER INFORMATION CONTACT: Eric 2. In section 2 of the Act, Congress merge or consolidate, directly or Olesh (Technical Information), Office of amended section 203(a) to add section indirectly, its facilities subject to the Energy Market Regulation, Federal 203(a)(7) to require notification for jurisdiction of the Commission, or any Energy Regulatory Commission, 888 certain transactions. Section 203(a)(7) part thereof, with the facilities of any First Street NE, Washington, DC 20426, provides that, not later than 180 days other person, or any part thereof, that (202) 502–6524, [email protected]. after the date of the enactment of section are subject to the jurisdiction of the Regine Baus (Legal Information), 203(a)(7), the Commission shall Commission and have a value in excess Office of the General Counsel, Federal promulgate a rule requiring any public of $10 million, by any means Energy Regulatory Commission, 888 utility that is seeking to merge or whatsoever.2 First Street NE, Washington, DC 20426, consolidate, directly or indirectly, its 2. Comments (202) 502–8757, [email protected]. facilities subject to the jurisdiction of the Commission, or any part thereof, 6. American Public Power Association SUPPLEMENTARY INFORMATION: In this with those of any other person, to notify (APPA), Edison Electric Institute (EEI), final rule, the Commission amends its the Commission of such transactions not Idaho Power Company (Idaho Power), regulations to establish that a public later than 30 days after the date on International Transmission Company 3 utility must seek authorization under which the transaction is consummated (ITC), National Rural Electric amended section 203(a)(1)(B) of the if: (1) The facilities, or any part thereof, Cooperative Association (NRECA), and Federal Power Act (FPA) to merge or to be acquired are of a value in excess Transmission Access Policy Study consolidate, directly or indirectly, its of $1 million; and (2) such public utility Group (TAPS) support the proposed facilities subject to the jurisdiction of is not required to secure a Commission changes to part 33 of the Commission’s the Commission, or any part thereof, order under amended section regulations to implement the $10 with the facilities of any other person, 203(a)(1)(B). million dollar threshold in amended or any part thereof, that are subject to 3. The Act also specifies that, not later section 203(a)(1)(B). APPA, EEI, Idaho the jurisdiction of the Commission and than two years after the date of Power, NRECA, and TAPS add that the have a value in excess of $10 million, enactment of this Act, the Commission change appropriately reflects the by any means whatsoever. In addition, shall submit to Congress a report that amended language of section 203, and as required by the Act, the Commission assesses the effects of the amendment Idaho Power states that it will ensure establishes a requirement to submit a made by section 1 and that such report the Commission focuses its time and notification filing for mergers or effort on larger, potentially more shall take into account any information 4 consolidations by a public utility if the collected under section 203(a)(7). The impactful transactions. EEI and ITC facilities to be acquired have a value in Act also requires that the Commission explain that it will also reduce excess of $1 million and such public administrative burdens on regulated provide for public notice and comment 5 utility is not required to secure with respect to the report. entities and the Commission. Commission authorization under 3. Commission Determination amended section 203(a)(1)(B). II. Discussion 7. We will revise the language in 4. As discussed below, commenters I. Background § 33.1(a)(1)(ii) of the Commission’s generally support the proposals in the regulations as proposed in the NOPR. 1. On November 15, 2018, the NOPR, including the proposed changes Commission issued a notice of proposed to implement amended section B. Notification Filing rulemaking (NOPR) 1 implementing ‘‘An 203(a)(1)(B) and to establish a 1. NOPR Act to amend section 203 of the Federal notification filing requirement pursuant Power Act’’ (Act), Public Law 115–247, to section 203(a)(7). Certain commenters 8. The Commission also proposed to 132 Stat. 3152. Section 1 of the Act request clarification of the procedures add § 33.12 to its regulations to require amended section 203(a)(1)(B) to provide associated with the notification filing public utilities whose transactions are that no public utility shall, without first while others recommend that the subject to section 203(a)(7) to file having secured an order of the Commission require additional notification of such transactions with Commission authorizing it to do so, information about the transactions the Commission. In particular, the merge or consolidate, directly or subject to the notification filing. In light Commission proposed that any public indirectly, its facilities subject to the of amended section 203(a)(1)(B), utility that is seeking to merge or jurisdiction of the Commission, or any commenters also request clarification on consolidate, directly or indirectly, its part thereof, with the facilities of any the Commission’s jurisdiction over facilities subject to the jurisdiction of other person, or any part thereof, that acquisitions of facilities from non- the Commission, or any part thereof, are subject to the jurisdiction of the public utilities. Lastly, commenters with those of any other person must Commission and have a value in excess request that the Commission continue to of $10 million, by any means 2 Id. P 3. In the NOPR, the Commission stated that consider and act on other pending public utilities required to maintain their books of whatsoever. Section 3 of the Act Commission rulemakings. We address account in accordance with the Commission’s provides that the amendment to section these issues below. Uniform System of Accounts under 18 CFR part 101 203(a)(1)(B) shall take effect 180 days must continue to file with the Commission after the date of enactment of the Act. A. Section 203(a)(1)(B) Dollar Threshold proposed journal entries for the purchase or sale of electric plant, consistent with the instructions to The primary effect of this amendment is 1. NOPR Account 102, Electric Plant Purchased and Sold. to establish a $10 million threshold on The Commission explained that the dollar 5. In the NOPR, the Commission transactions that will be subject to the threshold proposed in the NOPR does not apply to proposed two changes to part 33 of its Commission’s review and authorization this accounting filing requirement. Id. at n.1. regulations to bring them into 3 ITC filed comments on behalf of itself, Michigan under section 203(a)(1)(B). conformance with the Act. First, the Electric Transmission Company, LLC, ITC Midwest Commission proposed to revise LLC, and ITC Great Plains, LLC. 1 Implementation of Amended Section 4 See APPA Comments at 3; EEI Comments at 5; 203(a)(1)(B) of the Federal Power Act, Notice of § 33.1(a)(1)(ii) to provide that part 33 Idaho Power Comments at 1; NRECA Comments at Proposed Rulemaking, 83 FR 61338 (Nov. 29, 2018), will apply to any public utility seeking 3; TAPS Comments at 3. 165 FERC ¶ 61,091 (2018). authorization under section 203 to 5 See ITC Comments at 1; EEI Comments at 6.

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notify the Commission of such service requirements and notice obtained with an investment of less than transaction not later than 30 days after procedures. EEI requests clarification on $10 million.16 Further, AAI states that, the date on which the transaction is whether the notification filings can be because electricity markets are consummated if: (1) The facilities, or filed in standard word-document susceptible to the exercise of market any part thereof, to be acquired are of formats via eFiling. EEI and ITC also ask power due to the inelasticity of demand a value in excess of $1 million; and (2) whether these filings are purely and supply during times when capacity such public utility is not required to informational. Specifically, they ask that is constrained. AAI also states that even secure an order of the Commission the Commission clarify that: (1) It will small, strategic acquisitions can under section 203(a)(1)(B).6 not notice these proceedings for public incentivize capacity withholding.17 9. The Commission proposed that comment; (2) other persons are not 14. AAI therefore recommends that public utilities subject to section entitled to file responsive comments; the notification filing include: (1) The 203(a)(7) file the following information and (3) the Commission will not take wholesale markets in which the in this notification filing: (1) The exact any action on the filings. EEI and ITC jurisdictional facilities associated with name of the public utility and its request clarification that persons are not or affected by the transaction principal business address; and (2) a obligated to serve copies of these participate; (2) a current, 10-year history narrative description of the transaction, notification filings under 18 CFR of ownership changes involving the including the identity of all parties 385.2010 (Rule 2010 of the jurisdictional facilities associated with involved in the transaction and all Commission’s Rules of Practice and the transaction; and (3) the identity of jurisdictional facilities associated with Procedure).13 In contrast, Public Citizen, all energy affiliates and energy or affected by the transaction, the Inc. requests that the Commission subsidiaries owned by the acquirer of location of such jurisdictional facilities clarify whether the proposed the jurisdictional facilities that are the involved in the transaction, the date on notification filing will be subject to subject of the transaction. AAI also which the transaction was public notice so that the public can encourages the Commission to consummated, the consideration for the track transactions valued between $1 undertake a technical conference to transaction, and the effect of the million but at or below $10 million.14 review how the Commission will transaction on the ownership and 13. Others contend that the analyze these transactions to monitor control of such jurisdictional facilities.7 information proposed to be collected in market changes, given that the 10. The Commission proposed that the notification filing is insufficient. Commission is required to submit a the notification filings be filed in the American Antitrust Institute (AAI) report to Congress within two years first docket for section 203 filings for the suggests that more information should regarding the effects of amended section fiscal year (FY). For example, all be included in the notification filing to 203(a)(1)(B).18 notification filings made in FY2019 account for (1) small, successive 15. APPA, NRECA, and TAPS also would be filed in Docket No. EC19–1– horizontal or vertical acquisitions that request that the notification filing 000; all notification filings made in can result in accretion of market power include a requirement to identify energy FY2020 would be filed in Docket No. over time (serial transactions); (2) affiliates and energy subsidiaries and to EC20–1–000, etc.8 acquisitions of partial ownership shares include pre- and post-transaction organizational charts.19 APPA explains 2. Comments in strategic assets that can raise competitive concerns due to common that the affiliate information is 11. Most commenters support the and cross-ownership issues; and (3) important because it will allow the proposed notification filing.9 NRECA strategic acquisitions. AAI explains that, Commission and other stakeholders to explains that proposed § 33.12(a) through serial transactions, a utility may monitor whether a market participant is implementing the notification enhance its ability and incentive to engaged in multiple accretive requirement tracks the statutory engage in unilateral economic transactions valued at less than $10 language.10 EEI supports the withholding of physical capacity or to million, which APPA notes was a Commission’s proposal regarding the strategically operate its transmission or concern of the Commission in a 2016 notification requirement for transactions fuel transportation assets to frustrate notice of inquiry on requirements for valued between $1 million but at or rivals’ access to or foreclose them from section 203 transactions and section 205 below $10 million, which it states is wholesale markets.15 In addition, AAI market-based rate applications.20 consistent with the legislative goals of states that cross-ownership can facilitate NRECA and TAPS explain that the reducing regulatory burden and the anticompetitive exchange of information will be useful because paperwork burdens while still providing information and common ownership ownership structures and affiliate transparency.11 Idaho Power also can dampen incentives to compete relationships are growing more supports the proposal that there be no because more vigorous competition is complex.21 APPA states that the affiliate filing requirement for transactions less profitable than ‘‘cooperation’’ for information and organizational charts involving facilities with a value of less investors with partial shares in each of will result in only an incremental than $1 million, which it states will those rivals. AAI explains that, for burden to paperwork, but that the streamline the process for utilities and example, private equity firms, which are reduce the oversight burden on the numerous and active in electricity 16 Id. at 5–7. Commission.12 markets, can control or influence 17 Id. at 7–8. 12. Some commenters request managerial decision-making even with a 18 Id. at 9. clarification on associated process and partial or minority ownership share in 19 See APPA Comments at 3–4; NRECA Comments at 5–6; TAPS Comments at 4. an asset, and such influence may be 20 6 NOPR, 165 FERC ¶ 61,091 at P 4. APPA Comments at 4–5 (citing Modifications to Commission Requirements for Review of 7 Id. P 5. 13 See EEI Comments at 7–8; ITC Comments at 3– Transactions under Section 203 of the Federal 8 Id. P 8. 4. Rule 2010 requires, among other things, that Power Act and Market-Based Rate Applications 9 Idaho Power, EEI, APPA, ITC, and NRECA participants in a proceeding must serve copies of under Section 205 of the Federal Power Act, Notice support the proposed notification filing. their documents according to specified guidelines. of Inquiry, 81 FR 66649 (Sept. 28, 2016), 156 FERC 10 NRECA Comments at 4. 18 CFR 385.2010. ¶ 61,214 (2016) (Market Power NOI)). 11 EEI Comments at 7. 14 Public Citizen, Inc. Comments at 1–2. 21 See NRECA Comments at 5–6; TAPS 12 Idaho Power Comments at 2. 15 AAI Comments at 3–4. Comments at 5.

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information will be useful to include in section 203(a)(1) is no longer required. 2. Comments 22 the Commission’s report to Congress. Because the Commission has limited 21. Two commenters, EEI and ITC, NRECA also requests that the authority to review these transactions take issue with the Commission’s Commission require information on the under section 203, we will not hold a clarification on its jurisdiction. wholesale and transmission tariffs on technical conference on how the Specifically, EEI claims that the file with the Commission that are Commission will analyze these amended language of section related to the jurisdictional facilities transactions. Interested persons may 203(a)(1)(B) states that Commission involved in the transaction, which it track these transactions as they are filed approval is required only if the facilities claims will be useful to monitor the in the placeholder dockets described being acquired by the public utility are 23 rates associated with those facilities. above which provide a readily subject to the Commission’s TAPS maintains that the proposed searchable format for doing so. jurisdiction, which is ‘‘plainly read to notification filing includes little 18. However, AAI, APPA, NRECA, mean that the facilities are jurisdictional information compared to full section and TAPS raise a compelling argument before consummation of the proposed 203 applications and, because Congress regarding the transparency of transaction.’’ 28 EEI states that the required these filings, the information information as to energy affiliates. Commission should recognize that, as the Commission receives must be amended, the language of section sufficient for consumer protection Therefore, in addition to the information that the NOPR proposed to 203(a)(1)(B) has materially changed purposes and to produce a meaningful from the language that preceded the report for Congress.24 be collected, we will require notification filings to contain a statement regarding amendment. As a result, EEI explains 3. Commission Determination whether the parties to the transaction that the Duke Power Co. v. FPC case cited by the Commission does not 16. We will add § 33.12 to the are affiliates. This will allow additional squarely address the question raised by Commission’s regulations as proposed transparency as to whether these the amendment. EEI requests that, for in the NOPR to require that public transactions are negotiated at arm’s regulatory certainty, the Commission utilities submit a notification filing for length and whether these transactions reconsider and clarify its interpretation transactions subject to section 203(a)(7). could have an effect on a public utility’s of the types of facilities to which In response to the comments, we first rates. We will add a requirement for such a statement in the description of amended section 203(a)(1)(B) will clarify filing requirements associated 29 the transaction in § 33.12(b)(2)(i). apply. with the notification filings. Each 22. Similarly, ITC argues that the notification filing should be filed in the 19. As to the Commission’s report to plain language of amended section first docket for section 203 filings of the Congress that assesses the effects of 203(a)(1)(B) does not grant the FY. For example, all notification filings amended section 203(a)(1)(B), the Commission authority to review made in FY2019 would be filed in the Commission will provide for public transactions that involve a public Docket No. EC19–1–000; all notification notice and comments on the report prior utility’s acquisition of facilities from filings for FY2020 would be filed in to submitting it to Congress. non-public utilities. ITC asserts that, Docket No. EC20–1–000, etc. The C. Clarification on Jurisdiction of the under amended section 203(a)(1)(B), a notification filings may be filed in any public utility must obtain Commission format accepted in eLibrary as listed on Commission Under Section 203(a)(1)(B) 25 authorization only when proposing to the Commission’s website. In 1. NOPR merge or consolidate its own addition, we clarify that the notification Commission-jurisdictional facilities filings are intended to be informational. 20. In the NOPR, the Commission with another person’s Commission- The Commission will not notice the clarified that, except for mergers or jurisdictional facilities. ITC contends notification filings submitted into the consolidations that are valued at $10 that if the facilities would be placeholder docket (i.e., Docket No. million or less, the Commission will not Commission-jurisdictional if owned by EC19–1–000, etc.) and will not accept change its interpretation of the a jurisdictional entity, or will become so responsive comments from any persons transactions that are subject to the after the transaction is approved by the on the notification filings. The jurisdiction of the Commission under Commission and consummated, is Commission will not act on the the ‘‘merge or consolidate’’ clause of immaterial because the statutory notification filings that it receives. section 203(a)(1)(B). The Commission language requires that the facilities Because the notification filings are further explained that it interprets the ‘‘are’’ within the jurisdiction of the informational in nature, there is no amendment by Congress to section Commission, not that they will be at requirement to serve copies of the 203(a)(1)(B) as establishing a $10 some future time.30 ITC also maintains notification filings under Rule 2010 of million threshold, but not removing the that the Commission’s reliance on Duke the Commission’s Rules of Practice and Commission’s jurisdiction to review Power Co. is unavailing because the case Procedure. transactions with a higher value that involved the interpretation of older, no- 17. With one exception, we decline to involve a public utility’s acquisition of longer effective section 203(a)(1)(B) require additional information as facilities from non-public utilities 26 if requested by certain commenters. language, which conferred upon the those facilities will be subject to the Commission authority to review a Section 203(a)(7) provides the Commission’s jurisdiction after the Commission with limited authority to public utility’s proposed merger or transaction is consummated.27 consolidation of its own facilities with collect information in the notification 31 filings about transactions for which the facilities of ‘‘any other person.’’ In 26 prior Commission authorization under Non-public utilities refers to entities described addition, ITC claims that the court’s in section 201(f) of the FPA. 16 U.S.C. 824(f). observation about the Commission’s 27 See Duke Power Co. v. FPC, 401 F.2d 930, 941 22 APPA Comments at 5–6. (DC Cir. 1968) (Duke Power Co.) (‘‘We have no 28 23 NRECA Comments at 6–7. doubt that any acquisition from [a non-public EEI Comments at 9. 24 TAPS Comments at 4. utility] by a public utility of what would normally 29 Id. at 8–9. 25 FERC, Acceptable File Formats, http:// be a jurisdictional facility, such as a transmission 30 ITC Comments at 2–3. www.ferc.gov/docs-filing/elibrary/accept-file- line conducting interstate energy, would fall within 31 Id. at 3 (citing Duke Power Co., 401 F.2d at formats.asp (last updated Nov. 16, 2015). the purview of the clause under consideration.’’). 933).

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jurisdiction in that case is dicta because Commission under this part,’’ 34 which outstanding rulemakings. AAI argues, the case concerned whether a public means that, if facilities being acquired among other things, that if small utility’s acquisition of unambiguously are subject to the Commission’s transactions are excluded from non-jurisdictional distribution assets jurisdiction prior to the transaction, Commission review under section was within section 203(a)(1)(B)’s their owner by definition is a public 203(a)(1)(B), the Commission should ambit.32 utility. The use of the word ‘‘person,’’ maintain close oversight over the and not ‘‘public utility,’’ when workings of regional transmission 3. Commission Determination describing the facilities to be acquired organization markets and not relieve 23. We disagree with EEI’s and ITC’s suggests that Congress intended the sellers with market-based rate authority interpretation of the language of Commission to have jurisdiction over from filing a competitive analysis with amended section 203(a)(1)(B). Rather, the acquisition of facilities owned both the Commission, as was proposed in the we interpret the new statutory language by public utilities and non-public Notice of Proposed Rulemaking in as codifying the D.C. Circuit’s holding utilities, provided that those facilities Refinements to Horizontal Market Power in Duke Power Co. that the Commission are subject to the Commission’s Analysis for Sellers in Certain Regional has no jurisdiction over the acquisition jurisdiction after their acquisition by the Transmission Organization and of distribution or other facilities that are public utility. Independent System Operator non-jurisdictional even when owned by 25. Our interpretation is reinforced by Markets.38 AAI further notes that the a public utility. In amended section the legislative history of the Act, which Commission has not acted on two 203(a)(1)(B), the phrase ‘‘subject to the indicates that Congress intended critical rulemakings and requests that jurisdiction of the Commission’’ was amended section 203(a)(1)(B) only to the Commission make these a high used twice.33 First, the phrase was used establish a $10 million threshold for priority: Data Collection for Analytics to describe the facilities of a ‘‘public transactions subject to the Commission’s and Surveillance and Market-Based utility’’ that must be involved in a jurisdiction and not to alter any other Rate Purposes in Docket No. RM16–17– transaction in order for the Commission aspect of the Commission’s jurisdiction 000 (Data Collection NOPR) 39 and to have jurisdiction. By adding ‘‘subject over transactions. The House Report Modifications to Commission to the jurisdiction of the Commission’’ described the purpose of the Requirements for Review of to describe the facilities of a ‘‘public amendment as ‘‘amend[ing] the Federal Transactions under Section 203 of the utility,’’ we conclude that Congress Power Act to exempt facilities of a value Federal Power Act and Market-Based intended to exclude facilities, such as of $10,000,000 or less from this Rate Applications under Section 205 of 35 distribution facilities, that are not prohibition.’’ The Senate Report the Federal Power Act in RM16–21– otherwise subject to the jurisdiction of similarly describes the purpose of the 000.40 the Commission when owned by a amendment as to: ‘‘reduce the 27. APPA and TAPS request that, if public utility. When Congress again compliance burden of certain the Commission does not expand the uses the phrase ‘‘subject to the transactions valued under $10 million, information to be collected in the jurisdiction of the Commission’’ to including significant legal and notification filing, it should act on the modify the facilities of a ‘‘person,’’ we regulatory costs which are collected 36 Data Collection NOPR and proceed with interpret the phrase as having the same from customers.’’ Notably, as part of the relational database proposed meaning, rather than removing the its background discussion, the Senate therein.41 Commission’s jurisdiction over a public Report also includes a discussion of the utility’s acquisition of transmission Duke Power Co. decision and its holding 2. Commission Determination facilities previously owned by a non- regarding the Commission’s jurisdiction 28. We acknowledge commenters’ public utility. to approve transactions, but that report support and requests for action on other 24. That Congress did not intend to does not assert that the decision was pending rulemaking proceedings. limit the Commission’s jurisdiction to erroneous or otherwise suggest that the However, we emphasize that this the acquisition of transmission facilities amendment was intended to reverse the proceeding is limited in scope and only subject to the Commission’s jurisdiction Commission’s longstanding reliance on implements the changes specified in prior to the transaction is further Duke Power Co. to assert jurisdiction amended section 203. We will not supported by the fact that Congress over a public utility’s acquisition of address the status of other proceedings retained the language requiring that the transmission facilities from a non-public here. In addition, as explained above, utility.37 That neither the House Report facilities being acquired be owned by a we find that the information we will nor the Senate Report suggests that the ‘‘person,’’ instead of changing the collect under § 33.12 is sufficient to amendment was intended to remove the language to require that the facilities be satisfy the directive in the Act that the Commission’s jurisdiction over the owned by a ‘‘public utility.’’ Under Commission establish a notification acquisition of facilities from non-public section 201(e), a ‘‘public utility’’ is ‘‘any requirement. person who owns or operates facilities utilities also supports the conclusion subject to the jurisdiction of the that the amendment should not be read III. Information Collection Statement to have such an effect. 29. The Paperwork Reduction Act 32 Id. D. Other Pending Proceedings (PRA) 42 requires each federal agency to 33 Amended section 203(a)(1)(B) provides that no public utility shall, without first having secured an 1. Comments 38 AAI Comments at 9–10 (citing Refinements to order of the Commission authorizing it to do so, Horizontal Market Power Analysis for Sellers in ‘‘merge or consolidate, directly or indirectly, its 26. AAI requests that the Commission Certain Regional Transmission Organization and facilities subject to the jurisdiction of the carefully consider whether the revised Independent System Operator Markets, Notice of Commission, or any part thereof, with the facilities regulations for small transactions will Proposed Rulemaking, 165 FERC ¶ 61,268 (2018)). of any other person, or any part thereof, that are have an effect on the questions posed in 39 subject to the jurisdiction of the Commission and Id. at 10. have a value in excess of $10 million, by any means 40 Id. (citing Market Power NOI, 81 FR 66649, 156 34 whatsoever.’’ 16 U.S.C. 824b(a)(1)(B), amended by 16 U.S.C. 824(e). FERC ¶ 61,214). ‘‘An Act to amend section 203 of the Federal Power 35 H.R. Rep. No. 115–167, at 1 (2018). 41 See APPA Comments at 6–7; TAPS Comments Act,’’ Public Law 115–247, 132 Stat. 3152 (2018) 36 S. Rep. No. 115–253, at 2 (2018). at 5–6. (emphasis added). 37 Id. at 3. 42 44 U.S.C. 3501–3520.

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seek and obtain Office of Management indirectly, its facilities subject to the 31. In the NOPR, the Commission and Budget (OMB) approval before jurisdiction of the Commission, or any solicited comments on the undertaking a collection of information part thereof, with the facilities of any Commission’s need for this information, directed to 10 or more persons or other person, or any part thereof, that whether the information will have contained in a rule of general are subject to the jurisdiction of the practical utility, the accuracy of the applicability. OMB’s regulations 43 Commission and have a value in excess burden estimates, ways to enhance the require approval of certain information of $10 million, by any means quality, utility, and clarity of the collection requirements imposed by whatsoever. In addition, this final rule information to be collected or retained, agency rules. Upon approval of a adds § 33.12 to the Commission’s and any suggested methods for collection of information, OMB will regulations to implement the directive minimizing respondents’ burden, assign an OMB control number and an in new section 203(a)(7) that the including the use of automated expiration date. Respondents subject to Commission require a notification filing the filing requirements of an agency rule information techniques. Nonetheless, for mergers or consolidations by a will not be penalized for failing to while we expect that the regulatory public utility if the facilities to be respond to the collection of information revisions discussed herein will reduce unless the collection of information acquired have a value in excess of $1 the burdens on affected entities, we displays a valid OMB control number. million and such public utility is not solicit public comment regarding the 30. The revisions to the Commission’s required to secure Commission accuracy of the burden and cost regulations required in this final rule authorization under amended section estimates below. 203(a)(1)(B). We anticipate that the will bring the regulations in 32. Internal Review: The Commission revisions to the Commission’s conformance with the amendments to has reviewed the changes and has regulations, once effective, would section 203 enacted by Congress. The determined that such changes are reduce regulatory burdens. The first revision would implement necessary. Congress’ amendment to section Commission will submit the proposed 203(a)(1)(B), which provides that a reporting requirements to OMB for its 33. Burden Estimate 45: The estimated public utility must seek authorization to review and approval under section burden and cost for the requirements merge or consolidate, directly or 3507(d) of the PRA.44 contained in this final rule follow.

FERC–519, AS MODIFIED BY THIS FINAL RULE IN DOCKET NO. RM19–4–000

Number of Number and responses Total number Average burden Total burden Requirements type of per of responses hours & cost hours & respondents respondent per response total cost

(1) (2) (1) * (2) = (3) (4) (3) * (4)

FERC–519 (FPA Section 203 26 1 26 1 hr.; $79.00 ...... 26 hrs.; $2,054.00. Filings) 46.

Title: FERC–519, Application under Commission authorization under customers. As a result, the Commission Federal Power Act Section 203. amended section 203(a)(1)(B). must review all jurisdictional OMB Control No.: 1902–0082. Overview of the Data Collection: The dispositions, mergers, and acquisitions Action: Amendment to 18 CFR part FERC–519, ‘‘Application under Federal to evaluate that transaction’s effect on 33. Power Act section 203,’’ is necessary to competition. The Commission also Respondents: Public utilities subject enable the Commission to carry out its evaluates whether such transactions to Federal Power Act. responsibilities in implementing the have an effect on rates and regulation Abstract: Pursuant to ‘‘An Act to statutory provisions of section 203. and whether they result in cross- amend section 203 of the Federal Power Section 203 requires a public utility to subsidization. The Commission Act’’, the Commission will revise part seek Commission authorization of implements the filing requirements 33 of its regulations to establish that transactions in which a public utility associated with this review in the Code mergers or consolidations by a public disposes of jurisdictional facilities, of Federal Regulations (CFR) under 18 utility of facilities subject to the merges such facilities with the facilities CFR part 33. jurisdiction of the Commission that owned by another person, or acquires have a value in excess of $10 million are the securities of another public utility. 35. This final rule is limited to subject to Commission authorization. In The Commission must authorize these implementing amended FPA section addition, the Commission will add transactions if it finds that they will be 203(a)(1)(B) and proposing a notification § 33.12 to its regulations to establish a consistent with the public interest. requirement for certain transactions, notification requirement for mergers or 34. By entering into a certain both of which together represent a consolidations by a public utility if the transaction, a public utility may gain an reduction in the filing requirements for facilities to be acquired have a value in increased incentive and ability to public utilities under section 203. The excess of $1 million and such public exercise market power that can be to the Commission implements these changes utility is not required to secure detriment of effective competition and by mandate of Congress.

43 5 CFR part 1320. of what is included in the information collection complete. The number of respondents and 44 44 U.S.C. 3507(d). burden, refer to 5 CFR 1320.3. responses is based on Commission staff’s estimate 45 ‘‘Burden’’ is the total time, effort, or financial 46 Commission staff estimates that approximately that 13 percent of the approximately 200 section resources expended by persons to generate, 26 section 203 filings will change from full section 203 filings received will be affected by the changes maintain, retain, or disclose or provide information 203 filings to the notification filing described above herein, which represents a significant reduction in to or for a Federal agency. For further explanation and will take respondents one burden hour to burden hours.

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36. Interested persons may obtain that are less burdensome to small List of Subjects in 18 CFR Part 33 information on the reporting entities and an agency explanation of Electric utilities, Reporting and requirements by contacting the why alternatives were rejected. recordkeeping requirements, Securities. following: Federal Energy Regulatory 40. The SBA size standards for Commission, 888 First Street NE, electric utilities is based on the number By the Commission. Washington, DC 20426 [Attention: Ellen of employees, including affiliates. Issued: February 21, 2019. Brown, Office of the Executive Director] Under SBA’s standards, some Nathaniel J. Davis, Sr., Email: [email protected], Phone: transmission owners will fall under the Deputy Secretary. (202) 502–8663; fax: (202) 273–0873. following category and associated size In consideration of the foregoing, the 37. Comments concerning the threshold: Electric bulk power Commission amends part 33, chapter I, collection of information and the transmission and control, at 500 51 title 18, Code of Federal Regulations, as associated burden estimate(s) may also employees. follows: be sent to: Office of Information and 41. The Commission estimates that 26 Regulatory Affairs, Office of respondents could file notification PART 33—APPLICATIONS UNDER Management and Budget, 725 17th filings over the course of a year, with an FEDERAL POWER ACT SECTION 203 Street NW, Washington, DC 20503 estimated burden of 1 hour per [Attention: Desk Officer for the Federal response, at an estimated cost of $79.00 ■ 1. The authority citation for part 33 Energy Regulatory Commission]. Due to per respondent. The Commission continues to read as follows: security concerns, comments should be believes that none of the filers will be Authority: 16 U.S.C. 791a-825r, 2601– sent electronically to the following small entities. Therefore, the 2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352. _ Commission certifies that this final rule email address: oira submission@ ■ 2. Amend § 33.1 by revising paragraph will not have a significant economic omb.eop.gov. Please refer to FERC–519, (a)(1)(ii) to read as follows: OMB Control No. 1902–0082 in your impact on small entities. submission. VI. Document Availability § 33.1 Applicability, definitions, and blanket authorizations. IV. Environmental Analysis 42. In addition to publishing the full (a) * * * 38. The Commission is required to text of this document in the Federal (1) * * * prepare an Environmental Assessment Register, the Commission provides all (ii) Merge or consolidate, directly or or an Environmental Impact Statement interested persons an opportunity to indirectly, its facilities subject to the for any action that may have a view and/or print the contents of this jurisdiction of the Commission, or any significant adverse effect on the human document via the internet through part thereof, with the facilities of any environment.47 We conclude that FERC’s Home Page (http:// other person, or any part thereof, that neither an Environmental Assessment www.ferc.gov) and in FERC’s Public are subject to the jurisdiction of the nor an Environmental Impact Statement Reference Room during normal business Commission and have a value in excess is required for this final rule under hours (8:30 a.m. to 5:00 p.m. Eastern of $10 million, by any means § 380.4(a) of the Commission’s time) at 888 First Street NE, Room 2A, whatsoever; regulations, which provides a Washington DC 20426. 43. From FERC’s Home Page on the * * * * * categorical exemption for ‘‘approval of ■ actions under section[] . . . 203 . . . of internet, this information is available on 3. Add § 33.12 to read as follows: the Federal Power Act relating to . . . eLibrary. The full text of this document § 33.12 Notification requirement for certain acquisition or disposition of property is available on eLibrary in PDF and transactions. ... .’’48 Microsoft Word format for viewing, (a) Any public utility that is seeking printing, and/or downloading. To access V. Regulatory Flexibility Act to merge or consolidate, directly or this document in eLibrary, type the indirectly, its facilities subject to the 39. The Regulatory Flexibility Act of docket number excluding the last three 49 jurisdiction of the Commission, or any 1980 (RFA) generally requires a digits of this document in the docket part thereof, with those of any other description and analysis of final rules number field. person, shall notify the Commission of 44. User assistance is available for that will have significant economic such transaction not later than 30 days eLibrary and the FERC’s website during impact on a substantial number of small after the date on which the transaction normal business hours from FERC entities. The Small Business is consummated if: Administration’s (SBA) Office of Size Online Support at 202–502–6652 (toll (1) The facilities, or any part thereof, free at 1–866–208–3676) or email at Standards develops the numerical to be acquired are of a value in excess [email protected], or the definition of a small entity. These of $1 million; and standards are provided in the SBA Public Reference Room at (202) 502– (2) Such public utility is not required regulations at 13 CFR 121.201.50 The 8371, TTY (202) 502–8659. Email the to secure an order of the Commission RFA does not mandate any particular Public Reference Room at under section 203(a)(1)(B) of the Federal outcome in a rulemaking. It only [email protected]. Power Act. requires consideration of alternatives VII. Effective Date and Congressional (b) Such notification shall consist of Notification the following information: 47 Regulations Implementing the National (1) The exact name of the public 45. These regulations are effective Environmental Policy Act, Order No. 486, 52 FR utility and its principal business 47897 (Dec. 17, 1987), FERC Stats. & Regs. ¶ 30,783 March 27, 2019. The Commission has (1987). determined that this rule is not a ‘‘major address; and 48 (2) A narrative description of the 18 CFR 380.4(a)(16). rule’’ as defined in section 351 of the 49 5 U.S.C. 601–612. transaction, including: Small Business Regulatory Enforcement 50 13 CFR 121.201. See also U.S. Small Business (i) The identity of all parties involved Fairness Act of 1996. Administration, Table of Small Business Size in the transaction, whether such parties Standards Matched to North American Industry are affiliates, and all jurisdictional Classification System Codes (effective Feb. 26, 51 13 CFR 121.201, Sector 22 (Utilities), NAICS 2016), https://www.sba.gov/sites/default/files/files/ code 221121 (Electric Bulk Power Transmission and facilities associated with or affected by Size_Standards_Table.pdf. Control). the transaction;

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(ii) The location of such jurisdictional building are not entitled to the housing the minimum number of low-income facilities involved in the transaction; credit dollar amount that is allocated to units that must undergo physical (iii) The date on which the transaction the building unless, among other inspection is the lesser of 20 percent of was consummated; requirements, the allocation is pursuant the low-income units in the project, (iv) The consideration for the to a qualified allocation plan (QAP). A rounded up to the nearest whole transaction; and QAP provides standards by which a number of units, or the number of low- (v) The effect of the transaction on the State or local housing credit agency or income units set forth in the Low- ownership and control of such its Authorized Delegate within the Income Housing Credit Minimum Unit jurisdictional facilities. meaning of § 1.42–5(f)(1) (Agency) is to Sample Size Reference Chart in the [FR Doc. 2019–03326 Filed 2–25–19; 8:45 am] make these allocations. A QAP also revenue procedure (the REAC numbers). BILLING CODE 6717–01–P provides a procedure that an Agency The revenue procedure also applies the must follow in monitoring for same rule to determine the minimum compliance with the provisions of number of units that must undergo low- section 42. A plan fails to be a QAP income certification review. DEPARTMENT OF THE TREASURY unless, in addition to other The temporary regulations also Internal Revenue Service requirements, it provides a procedure required that Agencies continue to that the agency (or an agent or other comply with the all-buildings 26 CFR Part 1 private contractor of such agency) will requirement unless guidance published follow in monitoring for noncompliance in the Internal Revenue Bulletin [TD 9848] with the provisions of section 42 and in pursuant to § 1.42–5T(a)(iii) provides RIN 1545–BL39 notifying the Internal Revenue Service otherwise. Rev. Proc. 2016–15 provides of such noncompliance which such for such an exception. Under Rev. Proc. Amendments to the Low-Income agency becomes aware of and in 2016–15, the all-buildings requirement Housing Credit Compliance-Monitoring monitoring for noncompliance with does not apply to an Agency that uses Regulations habitability standards through regular the REAC protocol to satisfy the site visits. (Section 42(m)(1)(B)(iii)). physical inspection requirement, AGENCY: Internal Revenue Service (IRS), Section 1.42–5 (the compliance- because the Treasury Department and Treasury. monitoring regulations) describes some the IRS have determined that the REAC ACTION: Final regulations and removal of of the provisions that must be part of protocol is an acceptable method for temporary regulations. any QAP. As part of its compliance- satisfying both § 1.42–5(d) and the monitoring responsibilities, an Agency physical inspection requirement of SUMMARY: This document contains final must perform physical inspections and § 1.42–5T(c)(2)(ii) and (iii). regulations that amend the compliance low-income certification review. Finally, the temporary regulations monitoring regulations concerning the The compliance-monitoring decoupled the physical inspection and low-income housing credit under regulations specifically provide that, for low-income certification review and section 42 of the Internal Revenue Code each low-income housing project, an ended the same-units requirement. (Code). These final regulations revise Agency must conduct on-site Accordingly, an Agency is no longer and clarify the requirement to conduct inspections of all buildings within its required to conduct a physical physical inspections and review low- jurisdiction by the end of the second inspection and low-income certification income certifications and other calendar year following the year the last review of the same unit. Because the documentation. The final regulations building in the project is placed in units no longer needed to be the same, will affect owners of low-income service (the all-buildings requirement). an Agency may choose a different housing projects that claim the credit, Prior to the issuance of the temporary number of units for physical inspection the tenants in those low-income housing regulations, the regulations also and for low-income certification review projects, and the State and local housing provided that, for at least 20 percent of provided the Agency chooses at least credit agencies that administer the the project’s low-income units (the 20- the minimum number of low-income credit. percent rule), the Agency must both units. Further, an Agency may choose to inspect the units and review the low- conduct a physical inspection and low- DATES: Effective date: These regulations income certifications, the income certification review at different are effective on February 26, 2019. documentation supporting the times. Applicability Dates: For dates of certifications, and the rent records for On the same day the temporary applicability see § 1.42–5(h)(2). the tenants in those same units (the regulations were published, the FOR FURTHER INFORMATION CONTACT: same-units requirement). Treasury Department and the IRS also Barbara Campbell or YoungNa Lee, Under the temporary regulations, published a notice of proposed (202) 317–4137 (not a toll-free number). guidance published in the Internal rulemaking (REG–150349–12, 81 FR SUPPLEMENTARY INFORMATION: Revenue Bulletin may provide 9379) (the proposed regulations). The exceptions from, or alternative means of text of the proposed regulations Background satisfying, the inspection provisions of incorporated by cross-reference the text This document amends 26 CFR part 1 § 1.42–5(d). Rev. Proc. 2016–15 (2016– of the temporary regulations. The to finalize rules relating to section 42 of 11 I.R.B. 435) was published Treasury Department and the IRS the Code. On February 25, 2016, the concurrently with the temporary received written comments on the Department of the Treasury (Treasury regulations and provides that the U.S. proposed regulations. No requests for a Department) and the IRS published Housing and Urban Development (HUD) public hearing were made, and no temporary regulations (T.D. 9753) in the Real Estate Assessment Center Protocol public hearing was held. Federal Register (81 FR 9333), which (the REAC protocol) satisfies both The Treasury Department and the IRS amended § 1.42–5 of the Income Tax § 1.42–5(d) and the physical inspection considered the written comments in Regulations. requirements of § 1.42–5T(c)(2)(ii) and light of the questions presented in the Section 42(m)(1) provides that the (iii). The revenue procedure provides preamble of the temporary regulations. owners of an otherwise-qualifying that, in a low-income housing project, The Treasury Department and the IRS

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resolved those comments and questions conduct on-site inspections and low- housing credit income and gross-rent concerning the temporary regulations income certification review of the lesser restrictions. Agencies, however, and the interim guidance as discussed of— continue to have discretion to inspect in this preamble and incorporated in (1) 20 percent of the low-income units and review more units as they see fit. this Treasury Decision. in the low-income housing project, rounded up to the nearest whole II. Whether the Final Regulations Summary of Comments and number of units, or Should Retain the All-Buildings Explanation of Provisions (2) The Minimum Unit Sample Size Requirement I. Whether the REAC Numbers Should set forth in the Low-Income Housing The temporary regulations (§ 1.42– Replace the 20-Percent Rule for Physical Credit Minimum Unit Sample Size 5T(c)(2)(iii)(A)(1) and (2)) require that Inspection and Low-Income Reference Chart. (The numbers in the an Agency physically inspect all Certification Review chart come from the REAC protocol.) buildings in a low-income housing Second, in the preamble to T.D. 9753, project by the end of the second Historically, the Treasury Department the Treasury Department and the IRS calendar year following the year the last and the IRS have not required an expressed concern about application of building in the low-income housing Agency physically to inspect every low- the 20-percent rule for projects with a project is placed in service and at least income residential unit in a low-income relatively small number of low-income once every 3 years thereafter. However, project. Instead, if physical inspection units. The concern is that, in smaller Rev. Proc. 2016–15 excepts from this of a representative random sample of projects, physical inspections and the all-buildings requirement a project units yielded satisfactory results, the low-income certification review of 20 inspection conducted under the REAC Agency was permitted to infer that the percent of units (even a representative protocol. The exception was specifically uninspected units were similar. In such random sample) may not produce a carved out based on confidence in, and an exercise, a critical question is how sufficiently accurate estimate of the deference to, an inspection done under large a sample is needed to support uninspected units’ overall compliance HUD oversight. confidence in that inference. Decades with habitability and low-income Two commenters recommended that ago, the Treasury Department and the requirements. The preamble further the final regulations also dispense with IRS determined that a sample was states that the Treasury Department and the all-buildings requirement for adequate if it included at least 20 the IRS intend to consider replacing Agencies not using the REAC protocol. percent of a project’s low-income units, Rev. Proc. 2016–15 with a requirement The final regulations do not adopt this regardless of the total number of low- that does not permit use of the 20- recommendation. The REAC protocol income units in the project. (T.D. 8430, percent rule for projects with a requires that inspectors be specially 57 FR 40121, September 2, 1992). relatively small number of low-income trained in its use. When an Agency is The REAC protocol requires sample units. Comments were requested. not using that protocol, it may choose sizes that differ from those that the One commenter responded that it was inspectors of diverse expertise to Treasury Department and the IRS had not concerned about ending the 20- conduct inspections. The quality of required. In developing that protocol, percent rule for projects with a these inspections may vary across HUD sought to determine sample sizes relatively small number of low-income projects and jurisdictions. that would yield equally reliable units, because it is among those Under the all-buildings rule, if the inferences regardless of the size of the Agencies whose State or local rules randomly selected minimum number of number of residential units in a project. require them to inspect a minimum low-income units to be inspected fails to HUD’s statistical analysis produced number of units that exceeds the include at least one unit in one or more minimum sample sizes that are much minimum numbers in Rev. Proc. 2016– buildings in a project, then an Agency lower than 20 percent of large projects’ 15. may satisfy the requirement by units but somewhat higher than 20 These final regulations remove the inspecting some aspect of each omitted percent of total units for small projects. rule that allows minimum sample size building. These aspects might include The implication of the HUD conclusions to be the lesser of 20-percent of the total the building exterior, common area, was that the tax regulations’ 20 percent number of low-income units or the HVAC system, etc. In the absence of requirement for low-income housing minimum unit sample size set forth in HUD oversight, requiring that all- credit inspections may have been the Low-Income Housing Credit buildings be inspected serves as a unnecessarily burdensome for large Minimum Unit Sample Size Reference quality control mechanism. projects and may have failed adequately Chart. Instead, under these final to assess habitability in smaller ones. regulations, Agencies must inspect no III. Whether the Final Regulations In the temporary regulations the fewer units than the number specified Should Shorten the Reasonable-Notice Treasury Department and the IRS for projects of the relevant size as set Time Frame responded to that implication with a forth in the Low-Income Housing Credit The temporary regulations require an two-step process—minimum sample Minimum Unit Sample Size Reference Agency to select low-income units to size was reduced for large projects, and Chart. The Treasury Department and the inspect and low-income certifications to taxpayers were asked whether IRS have determined that the REAC review in a manner that will not give analogous statistical considerations numbers produce a statistically valid advance notice that a particular low- should be applied to increase minimum sampling of units, which establishes income unit (or low-income sample sizes for small ones. confidence in the compliance certifications for a particular low- First, under the temporary monitoring results for projects of income unit) will or will not be regulations, the 20-percent rule and the varying size. The Treasury Department inspected (or reviewed) for a particular REAC numbers (if an Agency is using and the IRS have further determined year. The temporary regulations allow the REAC protocol) are used by an that the REAC numbers reasonably an Agency to give an owner reasonable Agency for purposes of conducting balance burden on Agencies, tenants, notice that an inspection of the building physical inspections and the low- and building owners with the need to and low-income units or review of low- income certification reviews. Rev. Proc. adequately monitor habitability and income certifications will occur, 2016–15 provides that an Agency must compliance with the low-income whether or not an Agency is selecting

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the same units for inspection and for IV. Whether the Final Regulations The Treasury Department and the IRS low-income certification review. The Should Allow an Agency To Treat a note that the multiple-building election temporary regulations provide that Scattered Site or Multiple Buildings is a statutory requirement. Other than reasonable notice is generally no more With a Common Owner and Plan of treating these buildings as if such an than 30 days, but they also provide a Financing as One Low-Income Housing election had been made, commenters very limited extension for certain Project Absent a Multiple-Building did not suggest criteria according to extraordinary circumstances beyond an Election Under Section 42(g)(3)(D) which units in buildings in different Agency’s control such as natural Section 42(c)(2)(A) defines ‘‘qualified projects could be treated as statistically disasters and severe weather conditions. low-income building’’ as any building representative of each other. For that reason, the Treasury Department and The Treasury Department and the IRS that is part of a qualified low-income housing project at all times throughout the IRS are not adopting this requested comments on whether the recommendation in the final same maximum amount of notice is the compliance period. Section 42(g)(1) defines ‘‘qualified low-income housing regulations. reasonable for physical inspections as project’’ as any project for residential for low-income certification review. V. Certification and Review Provisions rental property if the project meets the Under § 1.42–5(c) Additionally, the Treasury Department requirements of section 42(g)(1)(A), (B), One commenter recommended that and the IRS requested comments on or (C), whichever is elected by the the regulations clarify that for properties whether, for physical inspections, the taxpayer. Section 42(g)(7) provides for a consisting of two or more separate reasonable-notice time frame should be scattered site project. Under that projects, monitoring Agencies may shortened. For example, under the provision, buildings that would (but for accept one certification form as long as REAC protocol, an inspector provides a their lack of proximity) be treated as a it contains an attachment that identifies 15-day notice of an upcoming HUD project shall be so treated if all of the all of the projects for which the inspection of a project but same-day dwelling units in each of the buildings certification is being made. The identification of the units to be are rent-restricted residential rental Treasury Department and the IRS inspected. No comments were received. units. Section 42(g)(3)(D) provides that decline to adopt the comment, because a project contains only one building These final regulations shorten the it is beyond the scope of the proposed unless, prior to the end of the first reasonable notice requirement to a 15- regulations. day notice that a project will experience calendar year in the project period (as an upcoming physical inspection or defined in section 42(h)(1)(F)(ii)), each Effect on Other Documents review of low-income certification. The building to comprise the project is The temporary regulations authorize Treasury Department and Internal identified in the form and the manner the IRS to provide in guidance that the Secretary provides. Taxpayers Revenue Service believe that the 15-day published in the Internal Revenue make the multiple-building election on notice period gives building owners Bulletin exceptions from, or alternative Form 8609 and by attaching a statement means of satisfying, the inspection reasonable notice that a review of low- identifying each of the buildings in a income certifications will occur and provisions of § 1.42–5(d). Rev. Proc. project subject to the election. 2016–15 was published concurrently gives building owners and tenants Two commenters recommended that, reasonable notice that a project will be with the temporary regulations and for purposes of compliance monitoring provides that the HUD REAC protocol inspected and that low-income units (including determining how many units will be inspected if they are in the satisfies both § 1.42–5(d) and the to inspect), the final regulations provide physical inspection requirements of the random sample that will later be special treatment to a scattered site or temporary regulations. These final selected. multiple buildings with a common regulations contain the guidance that The statistical validity of inspecting owner and plan of financing. The Agencies need and do not rely on the only a sample of the low-income units recommendation was that compliance IRS to provide in the Internal Revenue in a project depends on the sample monitoring be conducted as if the Bulletin exceptions from, or alternative being random and representative. Thus, multiple buildings were part of a single means of satisfying the inspection the validity would be destroyed if a project, even if the owner had not made provisions of § 1.42–5(d) or these final project owner had an opportunity to a multiple-building election under regulations. Accordingly, Rev. Proc. section 42(g)(3)(D). If the low-income selectively prepare the units in the 2016–15 is obsolete with respect to an units in all of the buildings were treated sample for inspection. Consistent with Agency as of the date on which the as potentially representative of each preserving the validity of the inspection Agency’s QAP is amended to reflect other (as would be the case if the these final regulations. In all cases, process, an Agency must select the low- buildings were part of a single project), income units to inspect in a manner that however, Rev. Proc. 2016–15 is obsolete the size of the sample to be inspected after December 31, 2020. will not give advance notice that a would be lower than the aggregate particular low-income unit will or will number of units to be inspected if the Applicability Date not be inspected. Accordingly, the final buildings are considered separately. The Department of Treasury and the regulations clarify that an Agency may Because of this separate treatment, IRS are aware that additional time may notify the owner of the particular low- according to these commenters, the be needed for Agencies’ QAPs to be income units for inspection only on the process of inspecting a number of small, amended. The final regulations allow day of inspection. The Treasury single-building projects (for example, Agencies a reasonable period of time to Department and IRS note that, under the single family, duplex, or triplex amend their QAPs, but QAPs must be REAC protocol, HUD or HUD-Certified buildings) located throughout a amended no later than December 31, REAC inspectors randomly select low- relatively large (possibly rural) 2020. income units for inspection on the day geographic area is unnecessarily Special Analyses of inspection. burdensome. In particular, separate treatment requires at least one unit of This regulation is not subject to each of the building to be inspected. review under section 6(b) of Executive

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Order 12866 pursuant to the low-income certifications (including in TABLE TO PARAGRAPH (c)(2)(iii)— Memorandum of Agreement (April 11, that term the documentation supporting Continued 2018) between the Department of the the low-income certifications and the Treasury and the Office of Management rent records for tenants). Number of low-in- and Budget regarding review of tax (iii) Require that the on-site Number of come units selected inspections that the Agency must for inspection or for regulations. Therefore, a regulatory low-income units in low-income certifi- impact assessment is not required. conduct satisfy both the requirements of the low-income cation review Because these regulations do not impose § 1.42–5(d) and the requirements in housing project (minimum unit sample a collection of information on small paragraph (c)(2)(iii)(A) through (D) of size) entities, the Regulatory Flexibility Act this section, and require that the low- (5 U.S.C. chapter 6) does not apply. income certification review that the 68–81 ...... 20 82–101 ...... 21 Pursuant to section 7805(f) of the Code, Agency must perform satisfies the 102–130 ...... 22 the notice of proposed rulemaking requirements in paragraphs (c)(2)(iii)(A) 131–175 ...... 23 preceding these regulations was through (D) of this section. Paragraph 176–257 ...... 24 submitted to the Chief Counsel for (c)(2)(iii)(A) through (D) of this section 258–449 ...... 25 Advocacy of the Small Business provides rules determining how these 450–1,461 ...... 26 Administration for comment on their on-site inspection requirements and 1,462–9,999 ...... 27 impact on small businesses. No how these low-income certification comments were received from the Small review requirements may be satisfied by (C) Selection of low-income units for Business Administration. an inspection or review, as the case may inspection and low-income be, that includes only a sample of the certifications for review—(1) Random Drafting Information low-income units. selection. The Agency must select in a The principal authors of these (A) Timing. The Agency must conduct random manner the low-income units to regulations are Barbara Campbell and on-site inspections of all buildings in be inspected and the units whose low- YoungNa Lee, Office of the Associate the low-income housing project and income certifications are to be reviewed. Chief Counsel (Passthroughs and must review low-income certifications Agencies generally may not select the Special Industries). However, other of the low-income housing project— same low-income units of a low-income personnel from the IRS and the Treasury (1) By the end of the second calendar housing project for on-site inspections Department participated in their year following the year the last building and low-income certification review, development. in the low-income housing project is because doing so would usually give placed in service; and prohibited advance notice. See List of Subjects in 26 CFR Part 1 (2) At least once every 3 years paragraph (c)(2)(iii)(C)(2) of this section. Income taxes, Reporting and thereafter. An Agency may choose a different recordkeeping requirements. (B) Number of low-income units. The number of units for on-site inspections Agency must conduct on-site and for low-income certification review, Adoption of Amendments to the inspections and low-income provided the Agency chooses at least Regulations certification review of not fewer than the minimum number of low-income Accordingly, 26 CFR part 1 is the minimum number of low-income units in each case. The Agency must amended as follows: units for the corresponding number of select the units for inspections or low- low-income units in the low-income income certification review separately PART 1—INCOME TAXES housing project set forth in the table to and in a random manner. paragraph (c)(2)(iii). (2) Advance notification limited to ■ Paragraph 1. The authority citation reasonable notice. The Agency must for part 1 is amended by removing the TABLE TO PARAGRAPH (c)(2)(iii) select the low-income units to inspect entry for § 1.42–5T to read in part as and low-income certifications to review follows: Number of low-in- in a manner that does not give advance Authority: 26 U.S.C. 7805 * * * Number of come units selected notice that a particular low-income unit low-income units in for inspection or for (or low-income certifications for a § 1.42–0T [Amended] low-income certifi- the low-income cation review particular low-income unit) will or will ■ Par. 2. Section 1.42–0T is amended by housing project (minimum unit sample not be inspected (or reviewed) for a removing the entry for § 1.42–5T. size) particular year. The Agency may notify the owner of the low-income units for ■ Par. 3. Section 1.42–5 is amended by: 1 ...... 1 on-site inspection only on the day of ■ 1. Removing paragraph (a)(2)(iii). 2 ...... 2 inspection. However, the Agency may ■ 2. Revising paragraphs (c)(2)(ii) and 3 ...... 3 give an owner reasonable notice that an (iii). 4 ...... 4 ■ 3. Revising paragraph (c)(3). 5–6 ...... 5 inspection of the project and of not-yet- ■ 4. Revising paragraph (h)(2). 7 ...... 6 identified low-income units or review of ■ 5. Removing paragraph (i). 8–9 ...... 7 low-income certifications will occur. The revisions and additions read as 10–11 ...... 8 The notice serves to enable the owner to follows: 12–13 ...... 9 assemble needed documentation for 14–16 ...... 10 low-income certifications for review and § 1.42–5 Monitoring compliance with low- 17–18 ...... 11 to notify tenants of the possibility of income housing credit requirements. 19–21 ...... 12 physical inspection of their units. 22–25 ...... 13 (3) Meaning of reasonable notice. For * * * * * 26–29 ...... 14 (c) * * * 30–34 ...... 15 purposes of paragraph (c)(2)(iii)(C)(2) of (2) * * * 35–40 ...... 16 this section, reasonable notice is (ii) Require that, with respect to each 41–47 ...... 17 generally no more than 15 days. The low-income housing project, the Agency 48–56 ...... 18 notice period begins on the date the conduct on-site inspections and review 57–67 ...... 19 Agency informs the owner that an on-

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site inspection of a project and low- under the REAC protocol satisfies the DEPARTMENT OF HOMELAND income units or low-income requirements of paragraph (c)(2)(iii)(C) SECURITY certification review will occur. Notice of of this section. more than 15 days, however, may be (6) Income Certification Requirements Coast Guard reasonable in extraordinary for HUD Inspections that comply with circumstances that are beyond an the requirements of the REAC Protocol. 33 CFR Part 165 Agency’s control and that prevent an An agency that conducts on-site Agency from carrying out within 15 inspections under the REAC protocol is [Docket No. USCG–2019–0084] days an on-site inspection or low- not excused from reviewing low-income income certification review. certifications in accordance with Safety Zone; Lower Mississippi River, Extraordinary circumstances include, paragraphs (c)(2)(ii) and (iii) of this Mile Markers 93 to 96 Above Head of but are not limited to, natural disasters section. Passes, New Orleans, LA and severe weather conditions. In the (7) Applicability of reasonable notice event of extraordinary circumstances limitation when the same units are AGENCY: Coast Guard, DHS. that result in a reasonable-notice period chosen for inspection and file review. If ACTION: Notice of enforcement of longer than 15 days, an Agency must the Agency chooses to select the same regulation. select the relevant units and conduct the units for on-site inspections and low- same-day on-site inspection or low- income certification review, the Agency SUMMARY: The Coast Guard will enforce income certification review as soon as must complete both the inspections and a safety zone for a fireworks display practicable. review before the end of the day on located between mile marker (MM) 93 (4) Alternative means of conducting which the units are selected. See on-site inspections—Use of the REAC and MM 96, above Head of Passes, paragraph (c)(2)(iii)(C)(1) and (2) of this Mississippi River. This action is needed protocol. An Agency may satisfy the section. requirements of paragraphs (c)(2)(ii) and to provide for the safety of life on (D) Method of low-income (iii) of this section if the inspection is navigable waterways during the certification review. The Agency may performed under the Department of Riverwalk Marketplace/Lundi Gras review the low-income certifications Housing and Urban Development (HUD) Fireworks event. wherever the owner maintains or stores Real Estate Assessment Center (REAC) DATES: The regulations in 33 CFR the records (either on-site or off-site). protocol and the inspection satisfies the 165.801, Table 5, line 1 will be enforced following requirements: (3) Frequency and form of from 6 p.m. through 7 p.m. on March 4, (i) Both vacant and occupied low- certification. A monitoring procedure 2019. income units in a low-income housing must require that the certifications and project are included in the population of reviews of § 1.42–5(c)(1) and (c)(2)(i) be FOR FURTHER INFORMATION CONTACT: If units from which units are selected for made at least annually covering each you have questions about this notice of inspection; year of the 15-year compliance period enforcement, call or email Lieutenant (ii) The inspection complies with the under section 42(i)(1). The certifications Commander Benjamin Morgan, Sector procedural and substantive must be made under penalties of New Orleans, U.S. Coast Guard; requirements of the REAC protocol, perjury. A monitoring procedure may telephone 504–365–2281, email including the requirements of the most require certifications and reviews more [email protected]. recent REAC Uniform Physical frequently than every 12 months, SUPPLEMENTARY INFORMATION: The Coast Condition Standards (UPCS) inspection provided that all months within each Guard will enforce the safety zone software, or software accepted by HUD; 12-month period are subject to described in 33 CFR 165.801, Table 5, (iii) The inspection is performed by certification. line 1, as the Riverwalk Marketplace/ HUD or HUD-Certified REAC inspectors; * * * * * Lundi Gras Fireworks Display event (iv) The inspection results are sent to (h) * * * from 6 p.m. through 7 p.m. on March 4, HUD, the results are reviewed and (2) Applicability dates. The 2019. This action is being taken to scored within HUD’s secure system requirements in paragraphs (c)(2)(ii) and provide for the safety of life on without any involvement of the (iii) and (c)(3) of this section apply navigable waterways during this event. inspector who conducted the beginning on February 26, 2019. A state Our regulation for marine events within inspection, and HUD makes its housing credit agency is allowed a the Eighth Coast Guard District, inspection report available. reasonable period of time to amend its § 165.801, specifies the location of the (5) HUD Inspections that comply with qualified allocation plan, but must regulated area for the Riverwalk the requirements of the REAC Protocol. amend its qualified allocation plan no Marketplace/Lundi Gras Fireworks If, consistent with the requirements of later than December 31, 2020. Display between mile markers 93 and 96 paragraph (c)(2)(iii)(4) of this section, an on the Mississippi River near New Agency conducts on-site inspections * * * * * Orleans, Louisiana. During the under the REAC protocol, then— § 1.42–5T [Removed] enforcement period, as reflected in (i) Paragraph (c)(2)(iii)(A) of this § 165.801(a)–(d), if you are the operator section is applied as if it did not contain ■ Par. 4. Section 1.42–5T is removed. of a vessel in the safety zone, you must the word ‘‘all’’; (ii) The number of low-income units Kirsten Wielobob, comply with directions from the required to be inspected under the Deputy Commissioner for Services and Captain of the Port or a designated REAC protocol satisfies the Enforcement. representative. requirements of paragraph (c)(2)(iii)(B) Approved: February 13, 2019. In addition to this notice of of this section concerning the number of David J. Kautter, enforcement in the Federal Register, the low-income units an Agency must Assistant Secretary of the Treasury (Tax Coast Guard plans to provide inspect; and Policy). notification of this enforcement period (iii) The manner in which the low- [FR Doc. 2019–03388 Filed 2–22–19; 4:15 pm] via the local notice to mariners and income units are selected for inspection BILLING CODE 4830–01–P marine information broadcasts.

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Dated: February 20, 2019. Docket is (703) 305–5805. Please review any Confidential Business Information K.M. Luttrell, the visitor instructions and additional (CBI)) for inclusion in the public docket. Captain, U.S. Coast Guard, Captain of the information about the docket available Information not marked confidential Port Sector New Orleans. at http://www.epa.gov/dockets. pursuant to 40 CFR part 2 may be [FR Doc. 2019–03253 Filed 2–25–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: disclosed publicly by EPA without prior BILLING CODE 9110–04–P Michael Goodis, Registration Division notice. Submit the non-CBI copy of your (7505P), Office of Pesticide Programs, objection or hearing request, identified Environmental Protection Agency, 1200 by docket ID number EPA–HQ–OPP– ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW, Washington, DC 2018–0032, by one of the following 20460–0001; main telephone number: methods: AGENCY • (703) 305–7090; email address: Federal eRulemaking Portal: http:// 40 CFR Part 180 [email protected]. www.regulations.gov. Follow the online instructions for submitting comments. SUPPLEMENTARY INFORMATION: [EPA–HQ–OPP–2018–0032; FRL–9987–83] Do not submit electronically any I. General Information information you consider to be CBI or Waxes and Waxy Substances, Rice other information whose disclosure is Bran, Oxidized; Exemption From the A. Does this action apply to me? restricted by statute. Requirement of a Tolerance You may be potentially affected by • Mail: OPP Docket, Environmental AGENCY: Environmental Protection this action if you are an agricultural Protection Agency Docket Center (EPA/ Agency (EPA). producer, food manufacturer, or DC), (28221T), 1200 Pennsylvania Ave. pesticide manufacturer. The following ACTION: Final rule. NW, Washington, DC 20460–0001. list of North American Industrial • Hand Delivery: To make special SUMMARY: This regulation establishes an Classification System (NAICS) codes is arrangements for hand delivery or exemption from the requirement of a not intended to be exhaustive, but rather delivery of boxed information, please tolerance for residues of waxes and provides a guide to help readers follow the instructions at http:// waxy substances, rice bran, oxidized determine whether this document www.epa.gov/dockets/contacts.html. when used as an inert ingredient in applies to them. Potentially affected Additional instructions on pesticide formulations applied to entities may include: commenting or visiting the docket, growing crops and raw agricultural • Crop production (NAICS code 111). along with more information about commodities after harvest, on animals, • Animal production (NAICS code 112). dockets generally, is available at http:// and in antimicrobial formulations (food- • Food manufacturing (NAICS code 311). www.epa.gov/dockets. • contact surface sanitizing solutions). Pesticide manufacturing (NAICS code II. Petition for Exemption Spring Trading Company, on behalf of 32532). Clariant Corporation, submitted a In the Federal Register of April 11, B. How can I get electronic access to 2018 (83 FR 15528) (FRL–9975–57), petition to EPA under the Federal Food, other related information? Drug, and Cosmetic Act (FFDCA), EPA issued a document pursuant to requesting establishment of an You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, exemption from the requirement of a electronic version of 40 CFR part 180 announcing the filing of a pesticide tolerance. This regulation eliminates the through the Government Printing petition (PP IN–11074) by Spring need to establish a maximum Office’s e-CFR site at http:// Trading Company, 203 Dogwood Trail, www.ecfr.gov/cgi-bin/text-idx?& Magnolia, TX 77354, on behalf of permissible level for residues of waxes _ and waxy substances, rice bran, c=ecfr&tpl=/ecfrbrowse/Title40/40tab Clariant Corporation. The petition oxidized in accordance with the terms 02.tpl. requested that 40 CFR 180.910, 180.930, and 180.940(a) be amended by of the exemptions. C. How can I file an objection or hearing establishing an exemption from the request? DATES: This regulation is effective requirement of a tolerance for residues February 26, 2019. Objections and Under FFDCA section 408(g), 21 of waxes and waxy substances, rice requests for hearings must be received U.S.C. 346a, any person may file an bran, oxidized (CAS Reg. No. 1883583– on or before April 29, 2019, and must objection to any aspect of this regulation 80–9) (‘‘rice bran wax oxidized’’), when be filed in accordance with the and may also request a hearing on those used as an inert ingredient as a flow aid, instructions provided in 40 CFR part objections. You must file your objection surface protection, film-forming, carrier, 178 (see also Unit I.C. of the or request a hearing on this regulation coating agent, and adjuvant in pesticide SUPPLEMENTARY INFORMATION). in accordance with the instructions formulations applied on growing crops ADDRESSES: The docket for this action, provided in 40 CFR part 178. To ensure and raw agricultural commodities after identified by docket identification (ID) proper receipt by EPA, you must harvest, to animals, and in antimicrobial number EPA–HQ–OPP–2018–0032, is identify docket ID number EPA–HQ– formulations (food-contact surface available at http://www.regulations.gov OPP–2018–0032 in the subject line on sanitizing solutions). That document or at the Office of Pesticide Programs the first page of your submission. All referenced a summary of the petition Regulatory Public Docket (OPP Docket) objections and requests for a hearing prepared by Spring Trading Company in the Environmental Protection Agency must be in writing, and must be on behalf of Clariant Corporation, the Docket Center (EPA/DC), West William received by the Hearing Clerk on or petitioner, which is available in the Jefferson Clinton Bldg., Rm. 3334, 1301 before April 29, 2019. Addresses for docket, http://www.regulations.gov. One Constitution Ave. NW, Washington, DC mail and hand delivery of objections comment was received on the notice of 20460–0001. The Public Reading Room and hearing requests are provided in 40 filing. EPA’s response to these is open from 8:30 a.m. to 4:30 p.m., CFR 178.25(b). comments is discussed in Unit V.C. Monday through Friday, excluding legal In addition to filing an objection or holidays. The telephone number for the hearing request with the Hearing Clerk III. Inert Ingredient Definition Public Reading Room is (202) 566–1744, as described in 40 CFR part 178, please Inert ingredients are all ingredients and the telephone number for the OPP submit a copy of the filing (excluding that are not active ingredients as defined

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in 40 CFR 153.125 and include, but are occur as a result of pesticide use in Rice ban wax oxidized was shown to not limited to, the following types of residential settings. If EPA is able to have low acute oral toxicity. There were ingredients (except when they have a determine that a finite tolerance is not no acute dermal or inhalation studies pesticidal efficacy of their own): necessary to ensure that there is a submitted; however, dermal and eye Solvents such as alcohols and reasonable certainty that no harm will irritation studies showed the rice bran hydrocarbons; surfactants such as result from aggregate exposure to the wax oxidized was not an irritant. Rice polyoxyethylene polymers and fatty inert ingredient, an exemption from the bran wax oxidized was also not acids; carriers such as clay and requirement of a tolerance may be considered a skin sensitizer in related diatomaceous earth; thickeners such as established. studies. carrageenan and modified cellulose; Consistent with FFDCA section No endpoint of concern was wetting, spreading, and dispersing 408(c)(2)(A), and the factors specified in identified for any of the acute, agents; propellants in aerosol FFDCA section 408(c)(2)(B), EPA has subchronic, chronic, or reproductive/ dispensers; microencapsulating agents; reviewed the available scientific data developmental studies conducted at any and emulsifiers. The term ‘‘inert’’ is not and other relevant information in dose level including the limit dose of intended to imply nontoxicity; the support of this action. EPA has 1000 mg/kg/day. There was also no ingredient may or may not be sufficient data to assess the hazards of evidence of carcinogenicity in any of the chemically active. Generally, EPA has and to make a determination on studies including chronic studies and exempted inert ingredients from the aggregate exposure for rice bran wax studies on mutagenicity and requirement of a tolerance based on the oxidized including exposure resulting cytotoxicity. In addition, no low toxicity of the individual inert from the exemption established by this neuropathological changes or effects ingredients. action. EPA’s assessment of exposures were reported in any of the studies. There is also no indication in the IV. Aggregate Risk Assessment and and risks associated with rice bran wax database that rice bran wax oxidized Determination of Safety oxidized follows. will be immunotoxic. Section 408(c)(2)(A)(i) of FFDCA A. Toxicological Profile Furthermore, the potential for allows EPA to establish an exemption EPA has evaluated the available absorption of rice bran wax via the from the requirement for a tolerance (the toxicity data and considered their gastrointestinal (GI) tract is limited. The legal limit for a pesticide chemical validity, completeness, and reliability as long-chain fatty acid esters present in residue in or on a food) only if EPA plant-based waxes are generally thought determines that the tolerance is ‘‘safe.’’ well as the relationship of the results of the studies to human risk. EPA has also to be poorly absorbed in the GI tract as Section 408(c)(2)(A)(ii) of FFDCA uptake is thought to decrease as chain defines ‘‘safe’’ to mean that ‘‘there is a considered available information concerning the variability of the length and hydrophobicity increase. reasonable certainty that no harm will Rice bran wax is being used as a result from aggregate exposure to the sensitivities of major identifiable subgroups of consumers, including surrogate for rice bran wax oxidized pesticide chemical residue, including based on its similar physical and all anticipated dietary exposures and all infants and children. Specific information on the studies received and chemical properties and expected other exposures for which there is potential for toxicity. Similar to rice reliable information.’’ This includes the nature of the adverse effects caused by rice bran wax oxidized, as well as the bran wax, which is poorly absorbed, it exposure through drinking water and in is unlikely that rice bran wax oxidized residential settings, but does not include no-observed-adverse-effect-level (NOAEL) and the lowest-observed- would be systemically available for GI occupational exposure. Section absorption, as both substance are 408(c)(2) requires EPA to take into adverse-effect-level (LOAEL) from the toxicity studies are discussed in this comprised of very long carbon chain account the factors specified in lengths which are not absorbed. subparagraphs (b)(2)(C) and (D) in unit. making this safety determination. Available studies on rice bran wax B. Toxicological Points of Departure/ Section 408(b)(2)(C) of FFDCA requires oxidized include an acute oral toxicity Levels of Concern EPA to give special consideration to study, a dermal irritation study, an eye Available toxicity studies on rice bran exposure of infants and children to the irritation study, a dermal sensitization wax oxidized indicate that it has a very pesticide chemical residue in study, and an Ames assay. No low acute, subchronic, and chronic establishing a tolerance and to ‘‘ensure subchronic or chronic studies are toxicity. No adverse effects were seen in that there is a reasonable certainty that available for rice bran wax oxidized. any of the studies presented at the limit no harm will result to infants and Because data on rice bran wax oxidized dose of 1000 mg/kg/day; therefore, no children from aggregate exposure to the is limited, surrogate data on various endpoint of concern has been identified pesticide chemical residue . . . .’’ other long chain fatty acids, long chain for acute, subchronic, or chronic EPA establishes exemptions from the fatty alcohols, and long chain fatty toxicity. requirement of a tolerance only in those esters were used to support the safety cases where it can be clearly finding for rice bran wax oxidized as C. Exposure Assessment demonstrated that the risks from rice bran wax oxidized is a natural 1. Dietary exposure from food and aggregate exposure to pesticide substance comprised predominantly of feed uses. In evaluating dietary chemical residues under reasonably long chain fatty acids, long chain fatty exposure to rice bran wax oxidized, EPA foreseeable circumstances will pose no alcohols, and long chain fatty esters. considered exposure under the appreciable risks to human health. In Submitted data consisted of numerous proposed exemption from the order to determine the risks from subchronic, chronic, and reproductive/ requirement of a tolerance and other aggregate exposure to pesticide inert developmental studies on substances natural sources of rice bran wax. EPA ingredients, the Agency considers the including carnauba wax, rice bran wax, assessed dietary exposures from rice toxicity of the inert in conjunction with a mixture of beeswax long chain bran wax oxidized in food as follows: possible exposure to residues of the alcohols, a mixture of sugar cane wax Dietary exposure to rice bran wax inert ingredient through food, drinking fatty acids, docosanol, docosanoic acid, oxidized may occur from eating foods water, and through other exposures that and policosanol. naturally containing rice bran wax

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(which is metabolized by the body to oxidized which does not use safety adjuvant) in pesticide formulations rice bran wax oxidized) and foods factors for assessing risk, and no applied to growing crops and raw treated with pesticide formulations additional safety factor is needed for agricultural commodities after harvest, containing rice bran wax oxidized as an assessing risk to infants and children. to animals, and in antimicrobial inert ingredient. Because no formulations (food-contact surface E. Aggregate Risks and Determination of toxicological endpoint of concern was sanitizing solutions). Safety identified for rice bran wax oxidized, a VII. Statutory and Executive Order quantitative dietary exposure Taking into consideration all available Reviews assessment for rice bran wax oxidized information on rice bran wax oxidized, was not conducted. EPA has determined that there is a This action establishes an exemption 2. Dietary exposure from drinking reasonable certainty that no harm to any from the requirement of a tolerance water. Although drinking water population subgroup will result from under FFDCA section 408(d) in exposures from use of pesticide aggregate exposure to rice bran wax response to a petition submitted to the formulations containing rice bran wax oxidized under reasonably foreseeable Agency. The Office of Management and oxidized on food crops is possible, an circumstances. Therefore, the Budget (OMB) has exempted these types endpoint of concern was not identified establishment of exemptions from the of actions from review under Executive for the acute or chronic dietary requirement of a tolerance under 40 CFR Order 12866, entitled ‘‘Regulatory assessment; therefore, a quantitative 180.910, 180.930, and 180.940(a) for Planning and Review’’ (58 FR 51735, dietary exposure risk assessment for residues of waxes and waxy substances, October 4, 1993). Because this action drinking water was not conducted. rice bran, oxidized when used as an has been exempted from review under 3. From non-dietary exposure. The inert ingredient in pesticide Executive Order 12866, this action is term ‘‘residential exposure’’ is used in formulations applied pre- and post- not subject to Executive Order 13211, this document to refer to non- harvest, on animals, and in entitled ‘‘Actions Concerning occupational, non-dietary exposure antimicrobial formulations (food-contact Regulations That Significantly Affect (e.g., textiles (clothing and diapers), surface sanitizing solutions), is safe Energy Supply, Distribution, or Use’’ (66 carpets, swimming pools, and hard under FFDCA section 408. FR 28355, May 22, 2001) or Executive surface disinfection on walls, floors, Order 13045, entitled ‘‘Protection of V. Other Considerations tables). Rice bran wax oxidized may be Children from Environmental Health used as inert ingredient in pesticide A. Analytical Enforcement Methodology Risks and Safety Risks’’ (62 FR 19885, products that are registered for specific An analytical method is not required April 23, 1997), nor is considered a uses that may result in indoor or for enforcement purposes since the regulatory action under Executive Order outdoor residential exposures. Since Agency is establishing an exemption 13771, entitled ‘‘Reducing Regulations there are no toxicological effects of from the requirement of a tolerance and Controlling Regulatory Costs’’ (82 concern at the limit dose in available without any numerical limitation. FR 9339, February 3, 2017). This action studies, a quantitative assessment of does not contain any information residential (non-occupational) B. Response to Comments collections subject to OMB approval exposures and risks is not necessary. One comment was received in under the Paperwork Reduction Act 4. Cumulative effects from substances response to the Notice of Filing, (PRA) (44 U.S.C. 3501 et seq.), nor does with a common mechanism of toxicity. generally stating that exposure to it require any special considerations Section 408(b)(2)(D)(v) of FFDCA unnecessary pesticides needs to be under Executive Order 12898, entitled requires that, when considering whether decreased. The Agency recognizes that ‘‘Federal Actions to Address to establish, modify, or revoke a some individuals believe that pesticides Environmental Justice in Minority tolerance, the Agency consider should be limited or banned on Populations and Low-Income ‘‘available information’’ concerning the agricultural crops. However, the existing Populations’’ (59 FR 7629, February 16, cumulative effects of a particular legal framework provided by section 1994). pesticide’s residues and ‘‘other 408 of the Federal Food, Drug and Since tolerances and exemptions that substances that have a common Cosmetic Act (FFDCA) states that are established on the basis of a petition mechanism of toxicity.’’ tolerances may be set when persons under FFDCA section 408(d), such as Rice bran wax oxidized does not have seeking such tolerances or exemptions the tolerance in this final rule, do not toxic mode of action and therefore, have demonstrated that the pesticide require the issuance of a proposed rule, cumulative risk assessment is not meets the safety standard imposed by the requirements of the Regulatory necessary. that statute. This citizen’s comment Flexibility Act (RFA) (5 U.S.C. 601 et appears to be directed at the underlying seq.), do not apply. D. Safety Factor for Infants and This action directly regulates growers, Children statute and not EPA’s implementation of it; the citizen has provided no food processors, food handlers, and food Section 408(b)(2)(C) requires EPA to information that would support a retailers, not States or tribes, nor does retain an additional tenfold margin of conclusion that these exemptions are this action alter the relationships or safety in the case of threshold effects to not safe. distribution of power and ensure that there is a reasonable responsibilities established by Congress certainty that no harm will result to VI. Conclusions in the preemption provisions of FFDCA infants and children from aggregate Therefore, exemptions from the section 408(n)(4). As such, the Agency exposure to the pesticide chemical requirement of a tolerance are has determined that this action will not residue. As noted in Unit IV.B., there is established under 40 CFR 180.910, have a substantial direct effect on States no indication of threshold effects being 180.930, and 180.940(a) for residues of or tribal governments, on the caused by rice bran wax oxidized at the waxes and waxy substances, rice bran, relationship between the national limit dose. Therefore, due to the lack of oxidized (CAS Reg. No. 1883583–80–9) government and the States or tribal any toxicological endpoints of concern when used as an inert ingredient (flow governments, or on the distribution of at the limit dose, EPA is conducting a aid, surface protectant, film-forming power and responsibilities among the qualitative assessment of rice bran wax agent, carrier, coating agent, or various levels of government or between

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the Federal Government and Indian VIII. Congressional Review Act Dated: December 21, 2018. tribes. Thus, the Agency has determined Donna Davis, that Executive Order 13132, entitled Pursuant to the Congressional Review Acting Director, Registration Division, Office ‘‘Federalism’’ (64 FR 43255, August 10, Act (5 U.S.C. 801 et seq.), EPA will of Pesticide Programs. 1999) and Executive Order 13175, submit a report containing this rule and Therefore, 40 CFR chapter I is entitled ‘‘Consultation and Coordination other required information to the U.S. amended as follows: with Indian Tribal Governments’’ (65 FR Senate, the U.S. House of 67249, November 9, 2000) do not apply Representatives, and the Comptroller PART 180—[AMENDED] to this action. In addition, this action General of the United States prior to ■ 1. The authority citation for part 180 does not impose any enforceable duty or publication of the rule in the Federal continues to read as follows: contain any unfunded mandate as Register. This action is not a ‘‘major described under Title II of the Unfunded rule’’ as defined by 5 U.S.C. 804(2). Authority: 21 U.S.C. 321(q), 346a and 371. Mandates Reform Act (UMRA) (2 U.S.C. List of Subjects in 40 CFR Part 180 ■ 2. In § 180.910, add alphabetically the 1501 et seq.). inert ingredient ‘‘Waxes and waxy This action does not involve any Environmental protection, substances, rice bran, oxidized (CAS technical standards that would require Administrative practice and procedure, Reg. No. 1883583–80–9)’’ to the table to Agency consideration of voluntary Agricultural commodities, Pesticides read as follows: consensus standards pursuant to section and pests, Reporting and recordkeeping requirements. § 180.910 Inert ingredients used pre- and 12(d) of the National Technology post-harvest; exemptions from the Transfer and Advancement Act requirement of a tolerance. (NTTAA) (15 U.S.C. 272 note). * * * * *

Inert ingredients Limits Uses

******* Waxes and waxy substances, rice bran, oxidized (CAS Reg...... Flow aid, surface protectant, film-forming agent, carrier, coat- No. 1883583–80–9). ing agent, or adjuvant.

*******

■ 3. In § 180.930, add alphabetically the Reg. No. 1883583–80–9)’’ to the table to § 180.930 Inert ingredients applied to inert ingredient ‘‘Waxes and waxy read as follows: animals; exemptions from the requirement substances, rice bran, oxidized (CAS of a tolerance. * * * * *

Inert ingredients Limits Uses

******* Waxes and waxy substances, rice bran, oxidized (CAS Reg...... Flow aid, surface protectant, film-forming agent, carrier, coat- No. 1883583–80–9). ing agent, or adjuvant.

*******

■ 4. In § 180.940(a), add alphabetically § 180.940 Tolerance exemptions for active (a) * * * the inert ingredient ‘‘Waxes and waxy and inert ingredients for use in substances, rice bran, oxidized’’ to the antimicrobial formulations (Food-contact table to read as follows: surface sanitizing solutions). * * * * *

Pesticide chemical CAS Reg. No. Limits

******* Waxes and waxy substances, rice bran, oxidized ...... 1883583–80–9 None.

*******

* * * * * [FR Doc. 2019–03295 Filed 2–25–19; 8:45 am] BILLING CODE 6560–50–P

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FEDERAL COMMUNICATIONS from 8:00 a.m. to 4:30 p.m. and Friday List of Subjects in 47 CFR Part 0 COMMISSION from 8:00 a.m. to 11:30 a.m. Authority delegations (Government 47 CFR Part 0 Synopsis agencies), Organization and functions (Government agencies). Section 502 of the Repack Airwaves Federal Communications Commission. [MD Docket No. 18–397; FCC 19–4] Yielding Better Access for Users of Modern Services Act of 2018 (RAY Katura Jackson, Memorializing the Significance of the Federal Register Liaison Officer, Office of the FCC’s Chief Information Officer’s Role BAUM’S Act), Division P of Public Law 115–141, provides the Commission’s Secretary. AGENCY: Federal Communications CIO with enhanced responsibilities. The Final Rules purpose of this Order is to amend 47 Commission. For the reasons discussed in the CFR 0.11 of the Commission’s ACTION: Final rule. preamble, the Federal Communications organizational rules to reflect the Commission amends 47 CFR part 0 as SUMMARY: In this document, the Federal specific CIO functions included in the follows: Communications Commission (FCC or RAY BAUM’S Act. Section 0.11 relates Commission) adopted a change to a rule to the functions of the FCC’s Office of PART 0—COMMISSION to incorporate a statutory update to the the Managing Director. The text of the ORGANIZATION authorities of the FCC’s Chief language that is being added to 47 CFR Information Officer (CIO) into the FCC’s 0.11 is the same as the language in ■ 1. The authority citation for part 0 organizational rules. The purpose of this Section 502 of the RAY BAUM’S Act. continues to read as follows: rule change is to demonstrate the FCC’s Section 502 is codified at 47 U.S.C. Authority: Sec. 5, 48 Stat. 1068, as commitment to ensuring that the FCC’s 155a. This update to the Commission’s amended; 47 U.S.C. 155, 225, unless CIO has a significant role in advancing organizational rules is not required by otherwise noted. the Commission’s overall information law. However, this update demonstrates ■ technology capabilities. the FCC’s commitment to ensuring that 2. Section 0.11 is amended by adding paragraph (c) to read as follows: DATES: Effective February 26, 2019. the CIO has a significant role in FOR FURTHER INFORMATION CONTACT: For advancing the Commission’s overall § 0.11 Functions of the Office. additional information, contact Daniel information technology capabilities. * * * * * Daly, [email protected], of the FCC’s Paperwork Reduction Act (c) The Chief Information Officer shall Office of the Managing Director, (202) have a significant role in: The decision- 418–1832. This document does not contain new making process for annual and multi- SUPPLEMENTARY INFORMATION: This is a or modified information collection year planning, programming, budgeting, summary of the Commission’s Order, requirements subject to the Paperwork and execution decisions, related FCC 19–4, adopted January 29, 2019 and Reduction Act of 1995 (PRA), Public reporting requirements, and reports released on January 30, 2019. The full Law 104–13. In addition, therefore, it related to information technology; the text of this document is available does not contain any new or modified management, governance, and oversight electronically via the FCC’s Electronic information collection burden for small processes related to information Document Management System business concerns with fewer than 25 technology; and the hiring of personnel (EDOCS) website at http://www.fcc.gov/ employees, pursuant to the Small with information technology edocs_public/ or via the FCC’s Business Paperwork Relief Act of 2002, responsibilities. The Chief Information Electronic Comment Filing System Public Law 107–198, see 44 U.S.C. Officer, in consultation with the Chief (ECFS) website at https://www.fcc.gov/ 3506(c)(4). Financial Officer and budget officials, shall specify and approve the allocation ecfs/. (Documents will be available Congressional Review Act electronically in ASCII, Microsoft Word, of amounts appropriated to the and/or Adobe Acrobat.) This document The Commission will not send a copy Commission for information technology, is also available for public inspection of this Order to Congress and the consistent with the provisions of and copying during regular business Government Accountability Office appropriations Acts, budget guidelines, hours in the FCC Reference Information pursuant to the Congressional Review and recommendations from the Director Center, which is located in Room CY– Act, see 5 U.S.C. 801(a)(1)(A), because of the Office of Management and A257 at FCC Headquarters, 445 12th the adopted rules are rules of agency Budget. Street SW, Washington, DC 20554. The organization, procedure, or practice that * * * * * Reference Information Center is open to do not ‘‘substantially affect the rights or [FR Doc. 2019–03277 Filed 2–25–19; 8:45 am] the public Monday through Thursday obligations of non-agency parties.’’ BILLING CODE 6712–01–P

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Proposed Rules Federal Register Vol. 84, No. 38

Tuesday, February 26, 2019

This section of the FEDERAL REGISTER • Fax comments to: Secretary, U.S. 415–4737, or by email to pdr.resource@ contains notices to the public of the proposed Nuclear Regulatory Commission at 301– nrc.gov. For the convenience of the issuance of rules and regulations. The 415–1101. reader, instructions about obtaining purpose of these notices is to give interested • Mail comments to: Secretary, U.S. materials referenced in this document persons an opportunity to participate in the Nuclear Regulatory Commission, are provided in the ‘‘Availability of rule making prior to the adoption of the final rules. Washington, DC 20555–0001, ATTN: Documents’’ section. Rulemakings and Adjudications Staff. • NRC’s PDR: You may examine and • Hand deliver comments to: 11555 purchase copies of public documents at NUCLEAR REGULATORY Rockville Pike, Rockville, Maryland the NRC’s PDR, Room O1–F21, One COMMISSION 20852, between 7:30 a.m. and 4:15 p.m. White Flint North, 11555 Rockville (Eastern Time) Federal workdays; Pike, Rockville, Maryland 20852. 10 CFR Part 72 telephone: 301–415–1677. B. Submitting Comments For additional direction on obtaining [NRC–2019–0030] information and submitting comments, Please include Docket ID NRC–2019– RIN 3150–AK28 see ‘‘Obtaining Information and 0030 in your comment submission. Submitting Comments’’ in the The NRC cautions you not to include List of Approved Spent Fuel Storage SUPPLEMENTARY INFORMATION section of identifying or contact information that Casks: Holtec International HI–STORM this document. you do not want to be publicly 100 Cask System, Certificate of disclosed in your comment submission. FOR FURTHER INFORMATION CONTACT: Compliance No. 1014, Amendment No. The NRC will post all comment Christian Jacobs, Office of Nuclear 13 submissions at http:// Material Safety and Safeguards; www.regulations.gov as well as enter the AGENCY: Nuclear Regulatory telephone: 301–415–6825; email: comment submissions into ADAMS. Commission. [email protected] or Gregory R. The NRC does not routinely edit ACTION: Proposed rule. Trussell, Office of Nuclear Material comment submissions to remove Safety and Safeguards; telephone: 301– identifying or contact information. SUMMARY: The U.S. Nuclear Regulatory 415–6244; email: Gregory.Trussell@ If you are requesting or aggregating Commission (NRC) is proposing to nrc.gov. Both are staff of the U.S. comments from other persons for amend its spent fuel storage regulations Nuclear Regulatory Commission, submission to the NRC, then you should by revising the Holtec International HI– Washington, DC 20555–0001. inform those persons not to include STORM 100 Cask System listing within SUPPLEMENTARY INFORMATION: identifying or contact information that the ‘‘List of approved spent fuel storage they do not want to be publicly Table of Contents casks’’ to include Amendment No. 13 to disclosed in their comment submission. Certificate of Compliance No. 1014. I. Obtaining Information and Submitting Your request should state that the NRC Amendment No. 13 would revise Comments does not routinely edit comment Appendix B of the technical II. Rulemaking Procedure submissions to remove such information specifications to update the initial III. Background before making the comment uranium weight for the 16x16B and IV. Plain Writing V. Availability of Documents submissions available to the public or 16x16C assembly classes to match the entering the comment into ADAMS. value for 16x16A. I. Obtaining Information and DATES: Submit comments by March 28, Submitting Comments II. Rulemaking Procedure 2019. Comments received after this date Because the NRC considers this action will be considered if it is practical to do A. Obtaining Information to be non-controversial, the NRC is so, but the NRC is able to ensure Please refer to Docket ID NRC–2019– publishing this proposed rule consideration only for comments 0030 when contacting the NRC about concurrently with a direct final rule in received on or before this date. the availability of information for this the Rules and Regulations section of this ADDRESSES: You may submit comments action. You may obtain publicly- issue of the Federal Register. The direct by any of the following methods: available information related to this final rule will become effective on May • Federal Rulemaking Website: Go to action by any of the following methods: 13, 2019. However, if the NRC receives http://www.regulations.gov and search • Federal Rulemaking Website: Go to significant adverse comments on this for Docket ID NRC–2019–0030. Address http://www.regulations.gov and search proposed rule by March 28, 2019, then questions about NRC dockets to Carol for Docket ID NRC–2019–0030. the NRC will publish a document that Gallagher; telephone: 301–415–3463; • NRC’s Agencywide Documents withdraws the direct final rule. If the email: [email protected]. For Access and Management System direct final rule is withdrawn, the NRC technical questions contact the (ADAMS): You may obtain publicly- will address the comments received in individuals listed in the FOR FURTHER available documents online in the response to these proposed revisions in INFORMATION CONTACT section of this ADAMS Public Documents collection at a subsequent final rule. Absent document. http://www.nrc.gov/reading-rm/ significant modifications to the • Email comments to: adams.html. To begin the search, select proposed revisions requiring [email protected]. If you ‘‘Begin Web-based ADAMS Search.’’ For republication, the NRC will not initiate do not receive an automatic email reply problems with ADAMS, please contact a second comment period on this action confirming receipt, then contact us at the NRC’s Public Document Room (PDR) in the event the direct final rule is 301–415–1677. reference staff at 1–800–397–4209, 301– withdrawn.

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A significant adverse comment is a Regulations section of this issue of the Storage of Spent Fuel at Power Reactor comment where the commenter Federal Register. Sites’’ (55 FR 29181; July 18, 1990). This explains why the rule would be rule also established a new subpart L in III. Background inappropriate, including challenges to 10 CFR part 72 entitled, ‘‘Approval of the rule’s underlying premise or Section 218(a) of the Nuclear Waste Spent Fuel Storage Casks,’’ which approach, or would be ineffective or Policy Act of 1982, as amended, contains procedures and criteria for unacceptable without a change. A requires that ‘‘[t]he Secretary [of the obtaining NRC approval of spent fuel comment is adverse and significant if: Department of Energy] shall establish a storage cask designs. The NRC (1) The comment opposes the rule and demonstration program, in cooperation subsequently issued a final rule on May provides a reason sufficient to require a with the private sector, for the dry 1, 2000 (65 FR 25241), that approved the substantive response in a notice-and- storage of spent nuclear fuel at civilian HI–STORM 100 Cask System design and comment process. For example, a nuclear power reactor sites, with the added it to the list of NRC-approved substantive response is required when: objective of establishing one or more cask designs in 10 CFR 72.214 as (a) The comment causes the NRC staff technologies that the [Nuclear Certificate of Compliance No. 1014. to reevaluate (or reconsider) its position Regulatory] Commission may, by rule, or conduct additional analysis; approve for use at the sites of civilian IV. Plain Writing (b) The comment raises an issue nuclear power reactors without, to the The Plain Writing Act of 2010 (Pub. serious enough to warrant a substantive maximum extent practicable, the need L. 111–274) requires Federal agencies to response to clarify or complete the for additional site-specific approvals by write documents in a clear, concise, record; or the Commission.’’ Section 133 of the well-organized manner. The NRC has (c) The comment raises a relevant Nuclear Waste Policy Act states, in part, written this document to be consistent issue that was not previously addressed that ‘‘[the Commission] shall, by rule, with the Plain Writing Act as well as the or considered by the NRC staff. establish procedures for the licensing of (2) The comment proposes a change any technology approved by the Presidential Memorandum, ‘‘Plain or an addition to the rule, and it is Commission under Section 219(a) [sic: Language in Government Writing,’’ apparent that the rule would be 218(a)] for use at the site of any civilian published June 10, 1998 (63 FR 31885). ineffective or unacceptable without nuclear power reactor.’’ The NRC requests comment on the incorporation of the change or addition. To implement this mandate, the proposed rule with respect to the clarity (3) The comment causes the NRC staff Commission approved dry storage of and effectiveness of the language used. to make a change (other than editorial) spent nuclear fuel in NRC-approved V. Availability of Documents to the rule, certificate of compliance, or casks under a general license by technical specifications. publishing a final rule which added a The documents identified in the For procedural information and the new subpart K in part 72 of title 10 of following table are available to regulatory analysis, see the direct final the Code of Federal Regulations (10 interested persons through one or more rule published in the Rules and CFR) entitled ‘‘General License for of the following methods, as indicated.

ADAMS Accession Document No./web link/ Federal Register citation

Letter from Holtec International dated November 19, 2018, Submitting Request for Amendment No. 13 to Certificate of Com- ML18325A154 pliance No. 1014. Proposed Certificate of Compliance No. 1014 Amendment No. 13, Certificate of Compliance for Spent Fuel Storage Casks .. ML18351A173 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix A ...... ML18351A174 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix B ...... ML18351A175 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix A–100U ...... ML18351A176 Proposed Certificate of Compliance No. 1014 Amendment No. 13, Technical Specifications, Appendix B–100U ...... ML18351A177 Certificate of Compliance No. 1014 Amendment No. 13, Preliminary Safety Evaluation Report ...... ML18351A178

The NRC may post materials related Intergovernmental relations, Nuclear PART 72—LICENSING to this document, including public energy, Penalties, Radiation protection, REQUIREMENTS FOR THE comments, on the Federal Rulemaking Reporting and recordkeeping INDEPENDENT STORAGE OF SPENT website at http://www.regulations.gov requirements, Security measures, NUCLEAR FUEL, HIGH-LEVEL under Docket ID NRC–2019–0030. The Whistleblowing. RADIOACTIVE WASTE, AND Federal Rulemaking website allows you REACTOR-RELATED GREATER THAN to receive alerts when changes or For the reasons set out in the CLASS C WASTE additions occur in a docket folder. To preamble and under the authority of the subscribe: (1) Navigate to the docket Atomic Energy Act of 1954, as amended; ■ 1. The authority citation for part 72 folder (NRC–2019–0030); (2) click the the Energy Reorganization Act of 1974, continues to read as follows: ‘‘Sign up for Email Alerts’’ link; and (3) as amended; the Nuclear Waste Policy Authority: Atomic Energy Act of 1954, enter your email address and select how Act of 1982, as amended; and 5 U.S.C. secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, frequently you would like to receive 552 and 553; the NRC is proposing to 183, 184, 186, 187, 189, 223, 234, 274 (42 emails (daily, weekly, or monthly). adopt the following amendments to 10 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, CFR part 72: 2099, 2111, 2201, 2210e, 2232, 2233, 2234, List of Subjects in 10 CFR Part 72 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, Administrative practice and 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); procedure, Hazardous waste, Indians, National Environmental Policy Act of 1969

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(42 U.S.C. 4332); Nuclear Waste Policy Act For the Nuclear Regulatory Commission. 3. Postal Mail: Appliance and of 1982, secs. 117(a), 132, 133, 134, 135, 137, Margaret M. Doane, Equipment Standards Program, U.S. 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), Executive Director for Operations. Department of Energy, Building 10152, 10153, 10154, 10155, 10157, 10161, Technologies Office, Mailstop EE–5B, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 [FR Doc. 2019–02887 Filed 2–25–19; 8:45 am] note. BILLING CODE 7590–01–P Test Procedure RFI for Direct Heating Equipment, Docket No. EERE–2019–BT– ■ 2. In § 72.214, Certificate of TP–0003, 1000 Independence Avenue Compliance 1014 is revised to read as DEPARTMENT OF ENERGY SW, Washington, DC, 20585–0121. If follows: possible, please submit all items on a compact disc (‘‘CD’’), in which case it is § 72.214 List of approved spent fuel 10 CFR Part 430 storage casks. not necessary to include printed copies. [EERE–2019–BT–TP–0003] 4. Hand Delivery/Courier: Appliance * * * * * Energy Conservation Program: Test and Equipment Standards Program, U.S. Certificate Number: 1014. Department of Energy, Building Initial Certificate Effective Date: May Procedure for Direct Heating Equipment Technologies Office, 950 L’Enfant Plaza 31, 2000. SW, Suite 600, Washington, DC, 20024. Amendment Number 1 Effective Date: AGENCY: Office of Energy Efficiency and Telephone: (202) 287–1445. If possible, July 15, 2002. Renewable Energy, Department of please submit all items on a CD, in Amendment Number 2 Effective Date: Energy. which case it is not necessary to include June 7, 2005. ACTION: Request for information. printed copies. Amendment Number 3 Effective Date: No telefacsimilies (faxes) will be May 29, 2007. SUMMARY: The U.S. Department of accepted. For detailed instructions on Amendment Number 4 Effective Date: Energy (‘‘DOE’’) is initiating a data submitting comments and additional January 8, 2008. collection process through this request information on this process, see section for information (‘‘RFI’’) to consider Amendment Number 5 Effective Date: III of this document. whether to amend DOE’s test procedure July 14, 2008. Docket: The docket for this activity, for direct heating equipment. To inform Amendment Number 6 Effective Date: which includes Federal Register interested parties and to facilitate this notices, comments, and other August 17, 2009. process, DOE has gathered data, Amendment Number 7 Effective Date: supporting documents/materials, is identifying several issues associated available for review at http:// December 28, 2009. with the currently applicable test www.regulations.gov. All documents in Amendment Number 8 Effective Date: procedures on which DOE is interested the docket are listed in the http:// May 2, 2012, as corrected on November in receiving comment. The issues www.regulations.gov index. However, 16, 2012 (ADAMS Accession No. outlined in this document mainly some documents listed in the index, ML12213A170); superseded by concern the evaluation of additional such as those containing information Amendment 8, Revision 1 Effective calculations relevant to the unvented that is exempt from public disclosure, Date: February 16, 2016. direct heating equipment test procedure, may not be publicly available. Amendment Number 8, Revision 1 updates to applicable industry The docket web page can be found at Effective Date: February 16, 2016. standards incorporated by reference in [http://www.regulations.gov/ Amendment Number 9 Effective Date: the vented direct heating equipment test docket?D=EERE-2019-BT-STD-0002]. March 11, 2014, superseded by procedure, and any additional topics The docket web page contains Amendment Number 9, Revision 1, on that may inform DOE’s decisions in a instructions on how to access all March 21, 2016. future test procedure rulemaking, documents, including public comments, Amendment Number 9, Revision 1, including methods to reduce regulatory in the docket. See section III of this Effective Date: March 21, 2016, as burden while ensuring the procedure’s document for information on how to corrected (ADAMS Accession No. accuracy. DOE welcomes written submit comments through http:// ML17236A451). comments from the public on any www.regulations.gov. Amendment Number 10 Effective subject within the scope of this Date: May 31, 2016, as corrected document (including topics not raised FOR FURTHER INFORMATION CONTACT: Dr. (ADAMS Accession No. ML17236A452). in this RFI). Stephanie Johnson, U.S. Department of Amendment Number 11 Effective DATES: Written comments and Energy, Office of Energy Efficiency and Date: February 25, 2019. information are requested and will be Renewable Energy, Building Amendment Number 12 Effective accepted on or before April 12, 2019. Technologies Office, EE–5B, 1000 Date: February 25, 2019. ADDRESSES: Interested persons are Independence Avenue SW, Washington, Amendment Number 13 Effective encouraged to submit comments using DC, 20585–0121. Telephone: (202) 287– Date: May 13, 2019. the Federal eRulemaking Portal at 1943. Email: Safety Analysis Report (SAR) http://www.regulations.gov. Follow the ApplianceStandardsQuestions@ Submitted by: Holtec International. instructions for submitting comments. ee.doe.gov. SAR Title: Final Safety Analysis Alternatively, interested persons may Mr. Eric Stas, U.S. Department of Report for the HI–STORM 100 Cask submit comments, identified by docket Energy, Office of the General Counsel, System. number EERE–2019–BT–TP–0003, by GC–33, 1000 Independence Avenue SW, Washington, DC, 20585–0121. Docket Number: 72–1014. any of the following methods: Telephone: (202) 586–5827. Email: Certificate Expiration Date: May 31, 1. Federal eRulemaking Portal: http:// [email protected]. 2020. www.regulations.gov. Follow the instructions for submitting comments. For further information on how to Model Number: HI–STORM 100. 2. Email: To DHE2019TP0003@ submit a comment or review other * * * * * ee.doe.gov. Include docket number public comments and the docket, Dated at Rockville, Maryland, this 14th day EERE–2019–BT–TP–0003 in the subject contact the Appliance and Equipment of February 2019. line of the message. Standards Program staff at (202) 287–

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1445 or by email: Part B 2 of EPCA established the Energy present oral and written comments on ApplianceStandardsQuestions@ Conservation Program for Consumer them. (42 U.S.C. 6293(b)(2)) ee.doe.gov. Products Other Than Automobiles, In addition, EPCA requires that DOE which sets forth a variety of provisions amend its test procedures for all covered SUPPLEMENTARY INFORMATION: designed to improve energy efficiency. products to integrate measures of Table of Contents These products include DHE, the standby mode and off mode energy subject of this RFI. (42 U.S.C. 6292(a)(9)) consumption into the overall energy I. Introduction Under EPCA, DOE’s energy efficiency, energy consumption, or other A. Authority and Background conservation program consists B. Rulemaking History energy descriptor, taking into essentially of four parts: (1) Testing, (2) consideration the most current versions II. Request for Information labeling, (3) Federal energy conservation A. Scope and Definitions of Standards 62301 and 62087 of the 1. Unvented Heaters standards, and (4) certification and International Electrotechnical 2. Vented Heaters enforcement procedures. Relevant Commission (‘‘IEC’’), unless the current B. Updates to Industry Standards provisions of the Act specifically test procedure already incorporates the 1. ANSI/ASHRAE 103 include definitions (42 U.S.C. 6291), standby mode and off mode energy 2. ANSI Z21.86 energy conservation standards (42 consumption, or if such integration is C. Test Method for Unvented Heaters U.S.C. 6295), test procedures (42 U.S.C. technically infeasible. (42 U.S.C. D. Test Method for Vented Heaters 6293), labeling provisions (42 U.S.C. E. Performance and Utility 6295(gg)(2)(A)) If an integrated test 6294), and the authority to require procedure is technically infeasible, DOE F. Other Test Procedure Topics information and reports from III. Submission of Comments must prescribe separate standby mode manufacturers (42 U.S.C. 6296). and off mode energy use test procedures I. Introduction Federal energy efficiency for the covered product, if a separate requirements for covered products test is technically feasible. (Id.) Direct heating equipment (DHE) is established under EPCA generally EPCA also requires that, at least once included in the list of ‘‘covered supersede State laws and regulations every 7 years, DOE evaluate test products’’ for which DOE is authorized concerning energy conservation testing, procedures for each type of covered to establish and amend energy labeling, and standards. (42 U.S.C. 6297) product, including DHE, to determine conservation standards and test DOE may, however, grant waivers of whether amended test procedures procedures. (42 U.S.C. 6292(a)(9)) The Federal preemption for particular State would more accurately or fully comply definition of ‘‘direct heating equipment’’ laws or regulations, in accordance with with the requirements for the test includes vented home heating the procedures and other provisions of procedures to not be unduly equipment and unvented home heating EPCA. (42 U.S.C. 6297(d)) equipment. 10 Code of Federal The Federal testing requirements burdensome to conduct and be Regulations (CFR) 430.2. (Hereafter in consist of test procedures that reasonably designed to produce test this notice, the terms ‘‘vented heater’’ manufacturers of covered products must results that reflect energy efficiency, and ‘‘unvented heater’’ are used to use as the basis for: (1) Certifying to energy use, and estimated operating describe the two types of direct heating DOE that their products comply with costs during a representative average equipment). DOE’s test procedures for the applicable energy conservation use cycle or period of use. (42 U.S.C. unvented heaters are prescribed at 10 standards adopted pursuant to EPCA (42 6293(b)(1)(A)) If the Secretary CFR part 430, subpart B, appendix G U.S.C. 6295(s)), and (2) making determines, on his own behalf or in (‘‘Appendix G’’). DOE’s test procedures representations about the efficiency of response to a petition by any interested for vented heaters are prescribed at 10 those consumer products (42 U.S.C. person, that a test procedure should be CFR part 430, subpart B, appendix O 6293(c)). Similarly, DOE must use these prescribed or amended, the Secretary (‘‘Appendix O’’). DOE prescribes energy test procedures to determine whether shall promptly publish in the Federal conservation standards for vented the products comply with relevant Register proposed test procedures and heaters at 10 CFR 430.32(i). DOE does standards promulgated under EPCA. (42 afford interested persons an opportunity not currently prescribe energy U.S.C. 6295(s)) to present oral and written data, views, conservation standards for unvented Under 42 U.S.C. 6293, EPCA sets forth and arguments with respect to such heaters. The following sections discuss the criteria and procedures DOE must procedures. The comment period on a DOE’s authority to establish and amend follow when prescribing or amending proposed rule to amend a test procedure test procedures for DHE, as well as test procedures for covered products. shall be at least 60 days and may not relevant background information EPCA requires that any test procedures exceed 270 days. In prescribing or regarding DOE’s consideration of test prescribed or amended under this amending a test procedure, the procedures for this product. section be reasonably designed to Secretary shall take into account such produce test results which measure information as the Secretary determines A. Authority and Background energy efficiency, energy use, or relevant to such procedure, including technological developments relating to The Energy Policy and Conservation estimated annual operating cost of a energy use or energy efficiency of the Act of 1975 (‘‘EPCA’’ or ‘‘the Act’’),1 covered product during a representative type (or class) of covered products Public Law 94–163 (42 U.S.C. 6291– average use cycle or period of use and involved. (42 U.S.C. 6293(b)(2)) If DOE 6317, as codified), among other things, requires that the test procedure not be determines that test procedure revisions authorizes DOE to regulate the energy unduly burdensome to conduct. (42 are not appropriate, DOE must publish efficiency of a number of consumer U.S.C. 6293(b)(3)) its determination not to amend the test products and industrial equipment. (42 If DOE determines that a test procedures. (42 U.S.C. 6293(b)(1)(A)(ii)) U.S.C. 6291–6317, as codified) Title III, procedure amendment is warranted, it must publish proposed test procedures DOE is publishing this RFI to collect data and information to inform its 1 and offer the public an opportunity to All references to EPCA in this document refer decision in satisfaction of the 7-year to the statute as amended through America’s Water Infrastructure Act of 2018, Public Law 115–270 2 For editorial reasons, upon codification in the review requirement specified in EPCA. (Oct. 23, 2018). U.S. Code, Part B was redesignated Part A. (42 U.S.C. 6293(b)(1)(A))

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B. Rulemaking History incorporated by reference six industry A. Scope and Definitions DOE’s existing test procedures for test standards to replace the outdated The test procedures for DHE cover unvented heaters and vented heaters test standards referred to in the then those products that meet the definitions appear at Appendix G and Appendix O, existing DOE test procedure. 80 FR 792 of ‘‘direct heating equipment’’ and respectively. DOE originally established (Jan. 6, 2015) (‘‘January 6, 2015 Final ‘‘home heating equipment,’’ as codified Appendix G in a final rule published in Rule’’). DOE determined at that time not at 10 CFR 430.2 and defined as follows: the Federal Register on May 10, 1978. to amend the test procedures for 1. ‘‘Direct heating equipment’’ means 43 FR 20128, 20132–20146. DOE unvented heaters. Id. at 793. vented home heating equipment and amended the test procedures for For unvented electric heaters that are unvented home heating equipment. unvented home heating equipment on the primary heating source for the 2. ‘‘Home heating equipment, not March 28, 1984 (‘‘March 28, 1984 final home, Appendix G includes provisions including furnaces’’ means vented home heating equipment and unvented home rule’’) to prescribe test procedures for for measuring electric power and heating equipment. fossil-fuel-fired unvented heaters and to calculating annual energy consumption. add a calculation of the estimated For all electric and gas unvented 1. Unvented Heaters operational cost per million British heaters, Appendix G includes The unvented heaters test procedure thermal unit (Btu) of output. 49 FR provisions for determining the rated covers those products that meet the 12148, 12157–12158. DOE most recently output. Appendix G does not contain definitions for ‘‘unvented home heating updated Appendix G in a final rule provisions for determining energy equipment,’’ as codified at 10 CFR published December 17, 2012 efficiency, as all unvented heaters are 430.2. DOE defines unvented heaters (‘‘December 17, 2012 final rule’’) to generally considered to be 100-percent and the various sub-types of unvented establish procedures for measuring efficient. Accordingly, DOE has not heaters as follows: energy consumption in standby mode established energy conservation 1. ‘‘Unvented home heating and off mode, pursuant to EPCA. 77 FR standards for unvented heaters. equipment’’ means a class of home 74559. 74571–74572. In the December heating equipment, not including 17, 2012 final rule, DOE did not For vented heaters, Appendix O includes provisions for determining furnaces, used for the purpose of incorporate standby mode and off mode furnishing heat to a space proximate to energy into the annual energy annual fuel utilization efficiency (‘‘AFUE’’), which is the efficiency such heater directly from the heater and consumption calculations for unvented without duct connections and includes metric used for determining compliance heaters because it determined that a electric heaters and unvented gas and with the energy conservation standards. detailed annual energy consumption oil heaters. accounting was not appropriate for Appendix O also specifies provisions 2. ‘‘Electric heater’’ means an electric unvented heaters, as described further for determining annual energy appliance in which heat is generated in section II.C of this document. 77 FR consumption. Manufacturers must use from electrical energy and dissipated by 74559, 74561. the test procedures at Appendix O to convection and radiation and includes DOE originally established Appendix demonstrate compliance with the baseboard electric heaters, ceiling O in a final rule published in the current energy conservation standards electric heaters, floor electric heaters, Federal Register on May 10, 1978. 43 for vented home heating equipment. portable electric heaters, and wall FR 20147, 20182–20205. DOE amended II. Request for Information electric heaters. the test procedures for vented home 3. ‘‘Primary heater’’ means a heating heating equipment in the March 28, In the following sections, DOE has device that is the principal source of 1984 final rule to include a simplified identified a variety of issues on which heat for a structure and includes procedure for heaters with modulating it seeks input to aid in the development baseboard electric heaters, ceiling controls, and to address manually of the technical and economic analyses electric heaters, and wall electric controlled vented heaters, vented regarding whether amended test heaters. heaters equipped with thermal stack procedures for DHE may be warranted. 4. ‘‘Supplementary heater’’ means a dampers, and floor furnaces. 49 FR Specifically, DOE is requesting heating device that provides heat to a 12148, 12169–12178. DOE amended the comment on any opportunities to space in addition to that which is test procedure for vented heaters again streamline and simplify testing supplied by a primary heater. on May 12, 1997 to add calculations for requirements for DHE. Supplementary heaters include portable electrical energy consumption, to clarify electric heaters. the pilot light energy measurement for Additionally, DOE welcomes 5. ‘‘Baseboard electric heater’’ means manually-controlled vented heaters, and comments on other issues relevant to an electric heater which is intended to to update the provisions for determining the conduct of this process that may not be recessed in or surface mounted on the efficiency of manually-controlled be specifically identified in this walls at floor level, which is heaters with variable input rates. 62 FR document. In particular, DOE notes that characterized by long, low physical 26140, 26156–26157. In the December under Executive Order 13771, dimensions, and which transfers heat by 17, 2012 final rule, DOE established ‘‘Reducing Regulation and Controlling natural convection and/or radiation. procedures for measuring power Regulatory Costs,’’ Executive Branch 6. ‘‘Ceiling electric heater’’ means an consumption in standby mode and off agencies such as DOE are directed to electric heater which is intended to be mode and for calculating the energy manage the costs associated with the recessed in, surface mounted on, or consumption associated with operation imposition of expenditures required to hung from a ceiling, and which transfers in standby mode and off mode. 77 FR comply with Federal regulations. See 82 heat by radiation and/or convection 74559, 74561. FR 9339 (Feb. 3, 2017). Pursuant to that (either natural or forced). In the most recent test procedure Executive Order, DOE encourages the 7. ‘‘Floor electric heater’’ means an rulemaking for DHE, DOE added public to provide input on measures electric heater which is intended to be provisions for testing vented home DOE could take to lower the cost of its recessed in a floor, and which transfers heating equipment that utilize regulations applicable to DHE consistent by radiation and/or convection (either condensing technology and with the requirements of EPCA. natural or forced).

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8. ‘‘Portable electric heater’’ means an taking air for combustion from outside • ‘‘UL 729–2003’’ means the test electric heater which is intended to this space. The vented floor furnace standard published by Underwriters stand unsupported, and can be moved supplies heated air circulated by gravity Laboratories, Inc. titled, ‘‘Standard for from place to place within a structure. or by a fan directly into the space to be Safety for Oil-Fired Floor Furnaces.’’ It is connected to electric supply by heated through openings in the casing. • ‘‘UL 730–2003’’ means the test means of a cord and plug, and transfers 3. ‘‘Vented room heater’’ means a self- standard published by Underwriters heat by radiation and/or convention contained, free standing, non-recessed, Laboratories, Inc. titled, ‘‘Standard for (either natural or forced). vented heater for furnishing warmed air Safety for Oil-Fired Wall Furnaces.’’ • 9. ‘‘Wall electric heater’’ means an to the space in which it is installed. The ‘‘UL 896–1993’’ means the test electric heater (excluding baseboard vented room heater supplies heated air standard published by Underwriters electric heaters) which is intended to be circulated by gravity or by a fan directly Laboratories, Inc. titled, ‘‘Standard for recessed in or surface mounted on into the space to be heated through Safety for Oil-Burning Stoves.’’ walls, which transfers heat by radiation openings in the casing. DOE conducted a preliminary and/or convection (either natural or 4. ‘‘Vented wall furnace’’ means a examination of the available industry forced) and which includes forced self-contained vented heater complete test standards and found that updates convectors, natural convectors, radiant with grilles or the equivalent, designed exist for all the incorporated standards except for ASTM D2156–09 and IEC heaters, high wall or valance heaters. for incorporation in, or permanent 62301 (Second Edition). DOE reviewed 10. ‘‘Unvented gas heater’’ means an attachment to, a wall of a residence and all of those updated industry test unvented, self-contained, free-standing, furnishing heated air circulated by standards. non-recessed gas-burning appliance gravity or by a fan directly into the which furnishes warm air by gravity or However, when reviewing the revised space to be heated through openings in versions of UL 729–2003 (last revised fan circulation. the casing. 11. ‘‘Unvented oil heater’’ means an November 22, 2016), 730–2003 (last Issue A.2 DOE requests comment on unvented, self-contained, free-standing, revised November 22, 2016), and 896– the definitions currently applicable to non-recessed oil-burning appliance 1993 (last revised November 22, 2016), vented heaters and whether any of the which furnishes warm air by gravity or DOE found that no revisions have been definitions should be revised, and if so, fan circulation. made to the sections incorporated by Issue A.1 DOE requests comment on how. Please provide a rationale for any reference to the vented heaters test the definitions currently applicable to suggested change. procedure. unvented heaters and whether any of B. Updates to Industry Standards Issue B.1 DOE requests any the definitions should be revised, and if information in relation to the revisions DOE’s current test procedures for DHE so, how. Please provide a rationale for to the existing standards that have been reference industry standards for various any suggested change. DOE notes that incorporated by reference, including the aspects of the test procedures. All floor electric heaters are not currently purpose of the updates and whether any materials incorporated by reference are listed among the other types of heaters of the updates would be expected to listed at 10 CFR 430.3 and within included in the definition of a ‘‘primary impact the test burden or measured Appendices G and O. DOE intends to heater.’’ DOE understands that floor energy consumption under the DOE test fully review all the referenced standards electric heaters have similar heat output procedures for vented and unvented in the DHE test procedures as part of as the types of heaters listed in the heaters. this evaluation. The following is a list definition of ‘‘primary heater’’ and may of the shorthand titles and full titles of 1. ANSI/ASHRAE 103 provide the primary source of heat in all the referenced industry standards small dwellings. DOE requests comment DOE is aware that ANSI/ASHRAE currently used in the DHE test on whether floor electric heaters should 103–2007 has been superseded by procedures. be specifically defined and also ANSI/ASHRAE 103–2017. DOE • ‘‘ANSI/ASHRAE 103–2007’’ means included in the definition of ‘‘primary examined both versions of the ANSI/ the test standard published by the heater.’’ ASHRAE 103 standard and found American Society of Heating, several changes to sections incorporated 2. Vented Heaters Refrigerating, and Air-Conditioning by reference within the vented heater The vented heaters test procedure Engineers titled, ‘‘Method of Test for test procedure. DOE understands many covers those products that meet the Annual Fuel Utilization Efficiency of of the changes to be minor clarifications, definitions for ‘‘vented home heating Residential Central Furnaces and such as adding metric units or changing equipment,’’ as codified at 10 CFR Boilers.’’ the order of a sentence without affecting • 430.2. DOE defines vented heaters and ‘‘ANSI Z21.86–2008’’ means the its intent. However, other changes could the various sub-types of vented heaters standard published by the American have a noticeable effect on the vented as follows: National Standards Institute titled, heater test procedure, if adopted by 1. ‘‘Vented home heating equipment’’ ‘‘Vented Gas-Fired Space Heating DOE. Specifically, in section 6.3, titled or ‘‘vented heater’’ means a class of Appliances.’’ ‘‘Pressure,’’ the allowable error value for home heating equipment, not including • ‘‘ASTM D2156–09’’ means the oil pressure measurement was removed, furnaces, designed to furnish warmed standard published by the American although the introductory text in the air to the living space of a residence, Society of Testing and Materials sections still states that it applies to oil. directly from the device, without duct International titled, ‘‘Standard Test In section 6.8, titled ‘‘Smoke,’’ the connections (except that boots not to Method for Smoke Density in Flue referenced standard ASTM D2156–94 exceed 10 inches beyond the casing may Gases from Burning Distillate Fuels.’’ was updated to ASTM D2156–09, which be permitted) and includes: Vented wall • ‘‘IEC 62301 (Second Edition)’’ is the standard that is currently furnace, vented floor furnace, and means the standard published by the incorporated by reference in the vented vented room heater. International Electrotechnical heater test procedure. In section 8.6, 2. ‘‘Vented floor furnace’’ means a Commission titled, ‘‘Household titled ‘‘Jacket Loss Measurement,’’ self-contained vented heater suspended electrical appliances—Measurement of figures 12 and 13 were replaced by a set from the floor of the space being heated, standby power’’ (Edition 2.0 2011–01). of equations. In section 9.10, titled

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‘‘Optional Test Procedures for the maximum electrical power, and of Appendix G specifies that the Condensing Furnaces and Boilers That section 3.2 specifies a calculation for the measurement of pilot light energy Have No Off-Period Flue Losses,’’ the annual energy consumption by consumption is not required. Similarly, maximum post-purge period to use a geographic region. The calculation of if the heater is designed to be turned off value of 0.05 for DF and DP increased national average annual energy when not in use, if turning the control from less than 5 seconds to less than or consumption in section 3.1 of Appendix to ‘‘off’’ will shut off the electrical equal to 30 seconds for units with no G is based on several assumptions, supply, and if an instruction to turn off measurable airflow through the including the national average annual the unit is provided on a label on the combustion chamber and heat heating load hours of 2080, an heater, then section 2.4.1 of Appendix G exchanger. adjustment factor of 0.77,3 and a typical specifies that the standby electrical Issue B.2 DOE requests comment on oversizing factor for primary electric power does not need to be measured. whether removing the allowable error in heaters of 1.2.4 The calculation of In the December 17, 2012 final rule, the oil pressure measurement value regional annual energy consumption in DOE determined not to include standby from section 6.3 of the ANSI/ASHRAE section 3.2 of Appendix G is based on mode and off mode energy use in the 103–2017 standard was intentional. If the same assumptions as the national annual energy consumption calculations so, DOE requests comment on what value, except that regional heating load for unvented heaters because a detailed allowable error measurement should be hours are provided by a figure depicting annual energy consumption accounting used within the vented heater test geographic regions the United States was not deemed appropriate for this procedure (Note: ANSI/ASHRAE 103– and the associated heating load hours product type (i.e., there is no annual ± 2007 stated 0.5 psi). for each region. accounting at all for supplemental Issue B.3 DOE requests comment on Issue C.1 DOE requests comment on heaters and only a simplified assigned whether the replacement of figures 12 whether the assumptions for calculating value for primary heaters). 77 FR 74559, and 13 with a set of equations in section the national and regional values of 74561. In the August 30, 2010 NOPR 8.6 of ANSI/ASHRAE 103–2017 is annual fuel energy consumption are still that preceded the December 17, 2012 appropriate for the vented heater test appropriate. final rule, DOE explained that the procedure. For unvented natural gas, propane, integration of standby mode and off Issue B.4 DOE requests comment on and oil heaters, section 2.2 of Appendix mode energy was not necessary or G specifies measuring the maximum whether the maximum post-purge time appropriate for the following reasons: should be increased from less than 5 fuel input rate of the heater over the seconds to less than or equal to 30 course of one hour. Section 2.1 of 1. The test procedure does not include seconds for vented heaters with no Appendix G requires the maximum energy efficiency or energy use metrics that measurable airflow through the auxiliary electrical power to be recorded would allow for the integration of standby mode and off mode energy use. combustion chamber and heat for unvented gas and oil heaters that use 2. Standby mode energy use (defined as exchanger. auxiliary electrical energy. Section 3.4 energy use during the heating season when of Appendix G provides calculations to 2. ANSI Z21.86 the heater is not on) is as effective in heating determine the rated output for unvented the space as active mode energy use. DOE is aware that ANSI Z21.86–2008 gas and oil heaters based on the 3. Off mode energy consumption (defined has been superseded by ANSI Z21.86– measurements of the hourly input rate as non-heating-season energy consumption) 2016. DOE examined both versions of and maximum electrical power. DOE could be considered ineffective energy use the ANSI Z21.86 standard and only notes that Appendix G currently does and, accordingly, could be minimized by found minor changes to sections not specify calculating annual fuel prescribing a separate energy conservation incorporated by reference within the energy consumption for unvented gas standard. However, DOE lacked data on vented heater test procedure. Section 6 consumer use that would be needed to define and oil heaters. a representative off mode for unvented was moved to section 9, and section 8 Issue C.2 DOE requests comment on heaters.5 whether annual fuel energy was moved to section 11. The figures See 75 FR 52892, 52898–52899 (Aug. consumption should be calculated for and tables referenced in these sections 30, 2010). were moved from the ‘‘Tables unvented natural gas, propane, and oil Issue C.3 DOE requests comment on Referenced In Part 1, Part II and heaters. If annual fuel energy whether annual fuel energy Exhibits’’ and ‘‘Figures Referenced In consumption should be calculated, DOE consumption for unvented heaters Part 1, Part II and Exhibits’’ sections at requests comment on what equations should include standby mode and off the end of the standard to throughout and assumptions should be used. mode energy use. DOE is also interested the standard where they are first For unvented heaters equipped with a in detailed information on any referenced. Accordingly, DOE expects pilot light and/or that use electrical additional test burden that would result that these changes would not energy, sections 2.3 and 2.4 of from calculating annual fuel energy substantively impact the test burden or Appendix G specify measuring the fossil consumption with standby mode and off measured energy consumption under fuel input rate and/or standby electrical mode energy use and if so, the nature the DOE test procedures. power, respectively. These values are not used in any calculations. If the pilot and extent of that burden. C. Test Method for Unvented Heaters light is designed to be turned off by the Issue C.4 DOE requests any For electric heaters, section 2.1 of user when not in use, and the heater has information in relation to annual and/or Appendix G specifies measuring and instructions for turning the unit off regional heating season data, heating recording the maximum electrical provided on a label on the heater near mode operating hours, standby mode power consumed when heating, in the gas control valve, then section 2.3.1 hours, and off mode hours for unvented terms of kilowatts, and section 3.3 heaters. specifies calculating a rated output. For 3 The adjustment factor is a multiplier to adjust primary electric heaters only, section the heating load hours to the approximate burner 5 For example, DOE lacked information on the operating hours actually experienced by the system. fraction of the year unvented heaters might be 3.1 of Appendix G specifies the 4 The oversizing factor accounts for space heating unplugged or otherwise disconnected from the calculation for the national average products generally being oversized when compared energy source, and the extent to which pilot lights annual energy consumption based on to the actual heating load. are turned off during the non-heating season.

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D. Test Method for Vented Heaters opposed to only those ‘‘without different results, especially in AFUE, For vented heaters, Appendix O thermostats.’’ and if so, the extent of such differences. Issue D.2 DOE requests comment on specifies provisions for determining the If any such difference in results would whether the definition for ‘‘Manually product’s AFUE, which is the efficiency occur, DOE requests comment on controlled vented heater’’ should be descriptor established by EPCA for whether any of these variables should amended, and if so, how. be obtained using equations instead of direct heating equipment. (42 U.S.C. Issue D.3 DOE also requests Table 3 or Figures 1 and 2. 6291(22)(A)) comment on whether the other In a notice of proposed rulemaking As discussed above, section 3.8 of definitions provided in section 1.0 of published October 24, 2013, DOE Appendix O contains provisions for Appendix O are all still appropriate, or proposed an optional use of a default testing vented heaters that utilize if other updates are needed. jacket loss value of 1 percent for vented condensing technology. Condensing Within section 4.0 of Appendix O, floor furnaces, as an alternative to technology is a design strategy that titled ‘‘Calculations,’’ the balance point performing a jacket loss test. 78 FR increases the efficiency of a heating temperature (TC) can be determined 63410, 63415. In the January 6, 2015 appliance by extracting additional either with an equation or using the 6 final rule, DOE decided not to adopt the thermal energy from the flue gases. values provided in Table 3 of Appendix 1 percent default jacket loss value for These provisions are essentially the O. DOE recognizes that a value of TC vented floor furnaces after reviewing same as those contained in ANSI/ derived from the equation may not be test data that revealed an average jacket ASHRAE 103–2007 that are applicable the same as that obtained from Table 3. loss of 3.05 percent. 80 FR 792, 794. to condensing furnaces and boilers. Similarly, values for the fraction of Issue D.6 DOE requests comment However, because of the numerous the heating load and average outdoor and test data on whether a higher additions and modifications needed to temperature at the reduced and default jacket loss value should be apply the condensing technology maximum operating modes (variables considered for vented floor furnaces. provisions to vented heaters, DOE X1, X2, TOA, and TOA*) are determined DOE previously stated that DHE that includes the condensing provisions in using either Table 3 or Figure 1 of can operate in manual or automatic Appendix O, rather than incorporating Appendix O (which provides a graph modes should be tested in automatic by reference the relevant provisions of showing TOA, and TOA* variables for any mode. 80 FR 792, 795 (Jan. 6, 2015). ANSI/ASHRAE 103–2007. balance point temperature between Issue D.7 DOE requests comment on Issue D.1 DOE requests comment 16 °F and 62 °F), or Figure 2 of whether DHE that have multiple and data on manufacturers’ and test Appendix O (which provides a graph automatic operation modes exist, and if laboratories’ experience with the showing variables X1 and X2 for any so, whether further direction regarding condensing provisions in Appendix O. balance point temperature between 0 °F the tested operating mode is necessary. DOE requests detailed information and 62 °F). DOE recognizes that Table 3, Section 3.6.1 of Appendix O specifies regarding any test burden associated Figure 1, and Figure 2 may yield that on units with no measurable with conducting the condensing different results because Table 3 airflow through the unit when not in provisions, including the nature and provides discreet values for X1, X2, TOA, heating mode (as determined by a extent of any such burden. DOE also and TOA*, whereas Figure 1 and Figure smoke stick test defined in section 3.6.2 requests comment on ways to 2 provide continuous graphical curves of Appendix O), both the off-cycle flue potentially reduce any test burden of the for determining the relevant variables. gas draft factor (DF) and the ratio of flue provisions specific to condensing DOE reviewed a limited amount of test gas mass flow during the off-period to technology. data in an effort to estimate the impact the flue gas mass flow during the on- DOE has identified several areas of of the different methods for determining period (DP) may be set equal to 0.05. the vented heater test procedure that the aforementioned variables on the DOE is considering whether to allow may warrant further review to measured AFUE value. DOE found that models using condensing or induced determine whether additional detail or the different methods resulted in a draft technology to automatically be specification may be needed to improve difference on the order of hundredths of considered to have no measurable the readability and ease of a percentage point of AFUE, which DOE airflow, and, thus, be able to use the implementation of the test procedure. would not expect to affect the measured defined value of 0.05 for DF and DP In the definitions in section 1.0 of AFUE in most cases when rounded to a without performing the smoke stick test. Appendix O, section 1.21 defines whole number. However, DOE seeks to Issue D.8 DOE requests comment on ‘‘manually controlled vented heaters’’ as further understand this issue and the extent to which vented heaters either gas or oil fueled vented heaters whether there are any known or currently use the provisions in 3.6.1 and equipped without thermostats. DOE potential impacts from the difference in 3.6.2 of Appendix O, whether models believes some vented heaters could values. with induced draft or condensing potentially be designed to operate with Issue D.4 DOE requests comment on technology are always capable of timers or electronic controls without whether the differences in the balance meeting the conditions to use the being equipped with thermostats, but point temperature (TC) produced by the default draft factor, and whether that are not manually controlled. DOE equation and as obtained from Table 3 provisions should be added to the questions whether ‘‘manually controlled can result in different results in the vented heater test procedure to allow vented heaters’’ should be defined to values for the fraction of the heating condensing or induced draft DHE to be exclude those ‘‘without automatic load (X1 and X2) and average outdoor considered to have no measurable means of control or operation,’’ as temperature at the reduced and airflow and to use a constant value of maximum operating modes (TOA and 0.05 for DF and DP without confirmation 6 In a condensing system, water vapor contained TOA*), and if so, the extent of any such testing. within the flue gas (as a byproduct of the difference. combustion process) is condensed and drained out Issue D.5 DOE requests comment on E. Performance and Utility of the system. The process of condensing water vapor into liquid water releases latent heat, which whether any differences in the values of DHE provides space heating (warm is transferred to the air stream, thereby increasing X1, X2, TOA, and TOA* within Table 3 air) directly to the consumer’s living the heating efficiency. and Figures 1 and 2 could produce space without the use of duct

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connections. Relevant to DHE may also procedures may be appropriate for these not include it in your comment or any be the ability to provide ‘‘quiet’’ products. accompanying documents. Instead, operation, non-heating air circulation, Submitting comments via http:// provide your contact information in a and space humidification, as well as the www.regulations.gov. The http:// cover letter. Include your first and last aesthetic appearance of the unit. www.regulations.gov web page will names, email address, telephone Issue E.1 DOE requests comment require you to provide your name and number, and optional mailing address. whether the test procedures impact the contact information. Your contact The cover letter will not be publicly availability of such features on DHE. information will be viewable to DOE viewable as long as it does not include Building Technologies staff only. Your any comments. F. Other Test Procedure Topics contact information will not be publicly Include contact information each time In addition to the issues identified viewable except for your first and last you submit comments, data, documents, earlier in this document, DOE welcomes names, organization name (if any), and and other information to DOE. If you comment on any other aspect of the submitter representative name (if any). submit via postal mail or hand delivery, existing test procedures for DHE not If your comment is not processed please provide all items on a CD, if already addressed by the specific areas properly because of technical feasible. It is not necessary to submit identified in this document. DOE difficulties, DOE will use this printed copies. No telefacsimiles (faxes) particularly seeks information that information to contact you. If DOE will be accepted. would improve the repeatability, cannot read your comment due to Comments, data, and other reproducibility, and consumer technical difficulties and cannot contact information submitted to DOE representativeness of the test you for clarification, DOE may not be electronically should be provided in procedures. DOE also requests able to consider your comment. PDF (preferred), Microsoft Word or information that would help DOE create However, your contact information Excel, WordPerfect, or text (ASCII) file a procedure that would limit will be publicly viewable if you include format. Provide documents that are not manufacturer test burden through it in the comment or in any documents secured, written in English, and free of streamlining or simplifying testing attached to your comment. Any any defects or viruses. Documents information that you do not want to be should not contain special characters or requirements. Comments regarding the publicly viewable should not be any form of encryption and, if possible, repeatability and reproducibility are included in your comment, nor in any they should carry the electronic also welcome. document attached to your comment. signature of the author. DOE also requests feedback on any Persons viewing comments will see only Campaign form letters. Please submit potential amendments to the existing first and last names, organization campaign form letters by the originating test procedure(s) that could be names, correspondence containing organization in batches of between 50 to considered to address impacts on comments, and any documents 500 form letters per PDF or as one form manufacturers, including small submitted with the comments. letter with a list of supporters’ names businesses. Regarding the Federal test Do not submit to http:// compiled into one or more PDFs. This method, DOE seeks comment on the www.regulations.gov information for reduces comment processing and degree to which the DOE test procedure which disclosure is restricted by statute, posting time. should consider and be harmonized such as trade secrets and commercial or Confidential Business Information. with the most recent relevant industry financial information (hereinafter Pursuant to 10 CFR 1004.11, any person standards for DHE and whether any referred to as Confidential Business submitting information that he or she changes to the Federal test method Information (‘‘CBI’’)). Comments believes to be confidential and exempt would provide additional benefits to the submitted through http:// by law from public disclosure should public. DOE also requests comment on www.regulations.gov cannot be claimed submit via email, postal mail, or hand the benefits and burdens of adopting as CBI. Comments received through the delivery two well-marked copies: One any industry/voluntary consensus-based website will waive any CBI claims for copy of the document marked or other appropriate test procedure, the information submitted. For ‘‘confidential’’ including all the without modification. information on submitting CBI, see the information believed to be confidential, Additionally, DOE requests comment Confidential Business Information and one copy of the document marked on whether the existing test procedures section. ‘‘non-confidential’’ with the information limit a manufacturer’s ability to provide DOE processes submissions made believed to be confidential deleted. additional features to consumers of through http://www.regulations.gov Submit these documents via email or on DHE. DOE particularly seeks before posting. Normally, comments a CD, if feasible. DOE will make its own information on how the test procedures will be posted within a few days of determination about the confidential could be amended to reduce the cost of being submitted. However, if large status of the information and treat it new or additional features and make it volumes of comments are being according to its determination. more likely that such features are processed simultaneously, your Factors of interest to DOE when included on DHE. comment may not be viewable for up to evaluating requests to treat submitted information as confidential include: (1) III. Submission of Comments several weeks. Please keep the comment tracking number that http:// A description of the item; (2) whether DOE invites all interested parties to www.regulations.gov provides after you and why such items are customarily submit in writing by April 12, 2019, have successfully uploaded your treated as confidential within the comments and information on matters comment. industry; (3) whether the information is addressed in this notice and on other Submitting comments via email, hand generally known by or available from matters relevant to DOE’s consideration delivery, or postal mail. Comments and other sources; (4) whether the of amended test procedures for DHE. documents submitted via email, hand information has previously been made These comments and information will delivery, or postal mail also will be available to others without obligation aid in the development of a test posted to http://www.regulations.gov. If concerning its confidentiality; (5) an procedure NOPR for DHE if DOE you do not want your personal contact explanation of the competitive injury to determines that amended test information to be publicly viewable, do the submitting person which would

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result from public disclosure; (6) when existing standards do not need to be that is exempt from public disclosure, such information might lose its amended. This request for information may not be publicly available. confidential character due to the (‘‘RFI’’) solicits information from the The docket web page can be found at passage of time, and (7) why disclosure public to help DOE determine whether http://www.regulations.gov/ of the information would be contrary to amended standards for direct heating #!docketDetail;D=EERE-2019-BT-STD- the public interest. equipment would result in significant 0002. The docket web page contains It is DOE’s policy that all comments energy savings and whether such instructions on how to access all may be included in the public docket, standards would be technologically documents, including public comments, without change and as received, feasible and economically justified. DOE in the docket. See section III of this including any personal information welcomes written comments from the document for information on how to provided in the comments (except public on any subject within the scope submit comments through http:// information deemed to be exempt from of this document (including topics not www.regulations.gov. public disclosure). raised in this RFI). FOR FURTHER INFORMATION CONTACT: Dr. DOE considers public participation to DATES: Written comments and Stephanie Johnson, U.S. Department of be a very important part of the process information are requested and will be Energy, Office of Energy Efficiency and for developing test procedures and accepted on or before April 12, 2019. Renewable Energy, Building energy conservation standards. DOE ADDRESSES: Interested persons are Technologies Office, EE–5B, 1000 actively encourages the participation encouraged to submit comments using Independence Avenue SW, Washington, and interaction of the public during the the Federal eRulemaking Portal at DC, 20585–0121. Telephone: (202) 287– comment period in each stage of this http://www.regulations.gov. Follow the 1943. Email: process. Interactions with and between instructions for submitting comments. ApplianceStandardsQuestions@ members of the public provide a Alternatively, interested persons may ee.doe.gov. balanced discussion of the issues and submit comments, identified by docket Mr. Eric Stas, U.S. Department of assist DOE in the process. Anyone who number EERE–2019–BT–STD–0002, by Energy, Office of the General Counsel, wishes to be added to the DOE mailing any of the following methods: GC–33, 1000 Independence Avenue SW, list to receive future notices and 1. Federal eRulemaking Portal: http:// Washington, DC 20585–0121. information about this process should www.regulations.gov. Follow the Telephone: (202) 586–5827. Email: contact Appliance and Equipment instructions for submitting comments. [email protected]. Standards Program staff at (202) 287– 2. Email: DHE2019STD0002@ For further information on how to 1445 or via email at ee.doe.gov. Include the docket number submit a comment or review other ApplianceStandardsQuestions@ EERE–2019–BT–STD–0002 in the public comments and the docket, ee.doe.gov. subject line of the message. contact the Appliance and Equipment Signed in Washington, DC, on February 13, 3. Postal Mail: Appliance and Standards Program staff at (202) 287– 2019. Equipment Standards Program, U.S. 1445 or by email: Steven Chalk, Department of Energy, Building ApplianceStandardsQuestions@ Acting Deputy Assistant Secretary for Energy Technologies Office, Mailstop EE–5B, ee.doe.gov. Efficiency, Energy Efficiency and Renewable Energy Conservation Standards RFI for SUPPLEMENTARY INFORMATION: Energy. Direct Heating Equipment, Docket No. Table of Contents [FR Doc. 2019–03269 Filed 2–25–19; 8:45 am] EERE–2019–BT–STD–0002, 1000 Independence Avenue SW, Washington, I. Introduction BILLING CODE 6450–01–P DC, 20585–0121. If possible, please A. Authority and Background submit all items on a compact disc B. Rulemaking Process II. Request for Information and Comments DEPARTMENT OF ENERGY (‘‘CD’’), in which case it is not necessary to include printed copies. A. Products Covered by This Process 4. Hand Delivery/Courier: Appliance 1. Unvented Heaters 10 CFR Part 430 2. Vented Heaters and Equipment Standards Program, U.S. [EERE–2019–BT–STD–0002] B. Market and Technology Assessment Department of Energy, Building 1. Product Classes Energy Conservation Program: Energy Technologies Office, 950 L’Enfant Plaza 2. Technology Assessment Conservation Standards for Direct SW, 6th Floor, Washington, DC, 20024. C. Screening Analysis Heating Equipment Telephone: (202) 287–1445. If possible, D. Engineering Analysis please submit all items on a CD, in 1. Baseline Efficiency Levels AGENCY: Office of Energy Efficiency and which case it is not necessary to include 2. Maximum Available and Maximum Renewable Energy, Department of printed copies. Technologically Feasible Levels Energy. No telefacsimilies (faxes) will be 3. Manufacturer Production Costs and Manufacturing Selling Price ACTION: Request for information. accepted. For detailed instructions on E. Mark-Up Analysis submitting comments and additional 1. Distribution Channels SUMMARY: The U.S. Department of information on this process, see section 2. Mark-Ups Energy (‘‘DOE’’) is initiating an effort to III of this document. F. Energy Use Analysis determine whether to amend the current Docket: The docket for this activity, 1. Sample Development energy conservation standards for direct which includes Federal Register 2. Energy Use Calculations heating equipment. Under the Energy notices, comments, and other G. Life-Cycle Cost and Payback Period Policy and Conservation Act of 1975, as supporting documents/materials, is Analysis amended (‘‘EPCA’’), DOE must available for review at http:// 1. Total Installed Cost 2. Operating Costs periodically review these standards and www.regulations.gov. All documents in H. Shipments Analysis publish either a notice of proposed the docket are listed in the http:// I. Manufacturer Impact Analysis rulemaking (‘‘NOPR’’) to propose new www.regulations.gov index. However, J. Other Energy Conservation Standards standards for direct heating equipment some documents listed in the index, Topics or a notice of determination that the such as those containing information 1. Market Failures

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2. Market-Based Approaches to Energy equipment) manufactured on or after DOE must make the analysis on which Conservation Standards April 16, 2013. 75 FR 20112. In the the determination is based publicly III. Submission of Comments April 2010 final rule, DOE did not issue available and provide an opportunity for I. Introduction standards for unvented home heating written comment. (42 U.S.C. 6295(m)(2)) equipment, a subset of DHE, finding that In making a determination, DOE must A. Authority and Background such standards would produce evaluate whether more-stringent The Energy Policy and Conservation insignificant energy savings. Id at standards would: (1) Yield a significant Act of 1975, as amended (‘‘EPCA’’ or 20130. Additionally, DOE completed a savings in energy use and (2) be both ‘‘the Act’’),1 Public Law 94–163 (42 second rulemaking cycle for DHE by technologically feasible and U.S.C. 6291–6317, as codified), among issuing a final determination to not economically justified. (42 U.S.C. other things, authorizes DOE to regulate amend standards for vented home 6295(m)(1)(A)) DOE is publishing this the energy efficiency of a number of heating equipment and to not to adopt RFI to collect data and information to consumer products and industrial standards for unvented home heating inform its decision consistent with its equipment. (42 U.S.C. 6291–6317, as equipment on October 17, 2016 obligations under EPCA. codified) Title III, Part B 2 of EPCA (‘‘October 2016 final determination’’). B. Rulemaking Process established the Energy Conservation 81 FR 71325. The current energy Program for Consumer Products Other conservation standards for DHE are DOE must follow specific statutory Than Automobiles, which sets forth a located in title 10 of the Code of Federal criteria for prescribing new or amended variety of provisions designed to Regulations (‘‘CFR’’) part 430, section standards for covered products. EPCA improve energy efficiency. These 32(i)(2). The currently applicable DOE requires that any new or amended products include direct heating test procedures for unvented and vented energy conservation standard be equipment (DHE), the subject of this DHE appear at 10 CFR part 430, subpart designed to achieve the maximum document. (42 U.S.C. 6292(a)(9)) EPCA B, appendix G and appendix O, improvement in energy or water prescribed energy conservation respectively. efficiency that is technologically standards for these products and In the October 2016 final feasible and economically justified. (42 directed DOE to conduct two cycles of determination, DOE concluded that U.S.C. 6295(o)(2)(A)) To determine rulemakings to determine whether to energy conservation standards should whether a standard is economically amend these standards. (42 U.S.C. not be amended for DHE. DOE justified, EPCA requires that DOE 6295(e)(3) and (4)) determined that the DHE market determine whether the benefits of the Under EPCA, DOE’s energy characteristics at the time were largely standard exceed its burdens by, to the conservation program consists similar to those during the analysis for greatest extent practicable, considering essentially of four parts: (1) Testing, (2) the April 2010 final rule, and that the the following seven factors: labeling, (3) Federal energy conservation technologies available for improving standards, and (4) certification and DHE energy efficiency had not advanced (1) The economic impact of the enforcement procedures. Relevant significantly since the publication of the standard on the manufacturers and provisions of the Act specifically April 2010 final rule. In addition, DOE consumers of the affected products; include definitions (42 U.S.C. 6291), test determined that the conclusions (2) The savings in operating costs procedures (42 U.S.C. 6293), labeling reached in the April 2010 final rule throughout the estimated average life of provisions (42 U.S.C. 6294), energy regarding the benefits and burdens of the product compared to any increases conservation standards (42 U.S.C. 6295), more stringent standards for DHE were in the initial cost, or maintenance and the authority to require information still relevant to the DHE market. expenses; and reports from manufacturers (42 Therefore, DOE concluded that (3) The total projected amount of U.S.C. 6296). amended energy conservation standards energy and water (if applicable) savings Federal energy efficiency would not be economically justified. 81 likely to result directly from the requirements for covered products FR 71325, 71325 (Oct. 17, 2016). standard; established under EPCA generally EPCA also requires that, not later than supersede State laws and regulations 6 years after the issuance of any final (4) Any lessening of the utility or the concerning energy conservation testing, rule establishing or amending a performance of the products likely to labeling, and standards. (42 U.S.C. 6297) standard, DOE evaluate the energy result from the standard; DOE may, however, grant waivers of conservation standards for each type of (5) The impact of any lessening of Federal preemption in limited instances covered product, including those at competition, as determined in writing for particular State laws or regulations, issue here, and publish either a notice by the Attorney General, that is likely to in accordance with the procedures and of determination that standards do not result from the standard; other provisions of EPCA. (42 U.S.C. need to be amended, or a NOPR (6) The need for national energy and 6297(d)) including new proposed energy water conservation; and DOE completed the first of the conservation standards (proceeding to a required rulemaking cycles in 2010 by final rule, as appropriate). (42 U.S.C. (7) Other factors the Secretary of publishing a final rule on April 16, 2010 6295(m)(1)) EPCA further provides that, Energy (Secretary) considers relevant. (‘‘April 2010 final rule’’) that adopted not later than 3 years after the issuance (42 U.S.C. 6295(o)(2)(B)(i)(I)–(VII)) amended performance standards for of a final determination not to amend certain DHE (i.e., vented home heating standards, DOE must publish either a DOE fulfills these and other notice of determination that standards applicable requirements by conducting 1 All references to EPCA in this document refer for the product do not need to be a series of analyses throughout the to the statute as amended through America’s Water amended, or a NOPR including new rulemaking process. Table I.1 shows the Infrastructure Act of 2018, Public Law 115–270 (Oct. 23, 2018). proposed energy conservation standards individual analyses that are performed 2 For editorial reasons, upon codification in the (proceeding to a final rule, as to satisfy each of the requirements U.S. Code, Part B was redesignated Part A. appropriate). (42 U.S.C. 6295(m)(3)(B)) within EPCA.

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TABLE I.1—EPCA REQUIREMENTS AND CORRESPONDING DOE ANALYSIS

EPCA requirement Corresponding DOE analysis

Technological Feasibility ...... • Market and Technology Assessment. • Screening Analysis. • Engineering Analysis. Economic Justification: 1. Economic impact on manufacturers and consumers ...... • Manufacturer Impact Analysis. • Life-Cycle Cost and Payback Period Analysis. • Life-Cycle Cost Subgroup Analysis. • Shipments Analysis. 2. Lifetime operating cost savings compared to increased cost for • Mark-ups for Product Price Determination. the product. • Energy and Water Use Determination. • Life-Cycle Cost and Payback Period Analysis. 3. Total projected energy savings ...... • Shipments Analysis. • National Impact Analysis. 4. Impact on utility or performance ...... • Screening Analysis. • Engineering Analysis. 5. Impact of any lessening of competition ...... • Manufacturer Impact Analysis. 6. Need for national energy and water conservation ...... • Shipments Analysis. • National Impact Analysis. 7. Other factors the Secretary considers relevant ...... • Employment Impact Analysis. • Utility Impact Analysis. • Emissions Analysis. • Monetization of Emission Reductions Benefits. • Regulatory Impact Analysis.

As detailed throughout this RFI, DOE A. Products Covered by This Process (2) ‘‘Electric heater’’ means an electric is publishing this document seeking appliance in which heat is generated The definitions for DHE were most from electrical energy and dissipated by input and data from interested parties to recently amended in a test procedure convection and radiation and includes aid in the development of the technical final rule. 80 FR 792 (Jan. 6, 2015). This baseboard electric heaters, ceiling analyses on which DOE will ultimately RFI covers those products that meet the electric heaters, floor electric heaters, rely to determine whether (and if so, definitions of ‘‘direct heating portable electric heaters, and wall how) to amend the standards for direct equipment’’ and ‘‘home heating heating equipment. 3 electric heaters. equipment,’’ as codified at 10 CFR (3) ‘‘Primary heater’’ means a heating II. Request for Information and 430.2 and defined as follows: device that is the principal source of Comments (1) ‘‘Direct heating equipment’’ means heat for a structure and includes vented home heating equipment and baseboard electric heaters, ceiling In the following sections, DOE has unvented home heating equipment. electric heaters, and wall electric identified a variety of issues on which (2) ‘‘Home heating equipment, not heaters. it seeks input to aid in the development including furnaces’’ means vented home (4) ‘‘Supplementary heater’’ means a of the technical and economic analyses heating equipment and unvented home heating device that provides heat to a regarding whether amended standards heating equipment. space in addition to that which is for DHE may be warranted. 1. Unvented Heaters supplied by a primary heater. Additionally, DOE welcomes comments Supplementary heaters include portable on other issues relevant to this request Unvented heaters are those products electric heaters. for information that may not specifically that meet the definitions for ‘‘unvented (5) ‘‘Baseboard electric heater’’ means be identified in this document. In home heating equipment,’’ as codified at an electric heater which is intended to particular, DOE notes that under 10 CFR 430.2. DOE defines unvented be recessed in or surface mounted on Executive Order 13771, ‘‘Reducing heaters and the various sub-types of walls at floor level, which is Regulation and Controlling Regulatory unvented heaters as follows: characterized by long, low physical Costs,’’ Executive Branch agencies such (1) ‘‘Unvented home heating dimensions, and which transfers heat by as DOE are directed to manage the costs equipment’’ means a class of home natural convection and/or radiation. (6) ‘‘Ceiling electric heater’’ means an associated with the imposition of heating equipment, not including electric heater which is intended to be expenditures required to comply with furnaces, used for the purpose of recessed in, surface mounted on, or Federal regulations. See 82 FR 9339 furnishing heat to a space proximate to hung from a ceiling, and which transfers (Feb. 3, 2017). Pursuant to that such heater directly from the heater and heat by radiation and/or convection Executive Order, DOE encourages the without duct connections and includes electric heaters and unvented gas and (either natural or forced). public to provide input on measures oil heaters. (7) ‘‘Floor electric heater’’ means an DOE could take to lower the cost of its electric heater which is intended to be energy conservation standards 3 DOE notes that DHE is defined at 10 CFR 430.2 recessed in a floor, and which transfers rulemakings, recordkeeping and as ‘‘vented home heating equipment’’ and by radiation and/or convection (either reporting requirements, and compliance ‘‘unvented home heating equipment’’; however, the natural or forced). and certification requirements existing energy conservation standards apply only (8) ‘‘Portable electric heater’’ means applicable to DHE while remaining to product classes of vented home heating equipment. There are no existing energy an electric heater which is intended to consistent with the requirements of conservation standards for unvented home heating stand unsupported, and can be moved EPCA. equipment. from place to place within a structure.

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It is connected to electric supply by (3) ‘‘Vented room heater’’ means a industry publications, and company means of a cord and plug, and transfers self-contained, free standing, non- websites, as well as information from heat by radiation and/or convention recessed, vented heater for furnishing trade journals, government agencies, (either natural or forced). warmed air to the space in which it is and trade organizations. Additionally, (9) ‘‘Wall electric heater’’ means an installed. The vented room heater DOE routinely conducts interviews with electric heater (excluding baseboard supplies heated air circulated by gravity manufacturers to improve its assessment electric heaters) which is intended to be or by a fan directly into the space to be of the market and available technologies recessed in or surface mounted on heated through openings in the casing. for DHE. walls, which transfers heat by radiation (4) ‘‘Vented wall furnace’’ means a and/or convection (either natural or self-contained vented heater complete 1. Product Classes forced) and which includes forced with grilles or the equivalent, designed When evaluating and establishing convectors, natural convectors, radiant for incorporation in, or permanent energy conservation standards, DOE heaters, high wall or valance heaters. attachment to, a wall of a residence and may divide covered products into (10) ‘‘Unvented gas heater’’ means an furnishing heated air circulated by product classes by the type of energy unvented, self-contained, free-standing, gravity or by a fan directly into the used, or by capacity or other non-recessed gas-burning appliance space to be heated through openings in performance-related features that justify which furnishes warm air by gravity or the casing. a different standard. (42 U.S.C. 6295(q)) fan circulation. (5) ‘‘Unvented home heating In making a determination whether (11) ‘‘Unvented oil heater’’ means an equipment’’ means a class of home unvented, self-contained, free-standing, heating equipment, not including capacity or another performance-related non-recessed oil-burning appliance furnaces, used for the purpose of feature justifies a different standard, which furnishes warm air by gravity or furnishing heat to a space proximate to DOE must consider such factors as the fan circulation. such heater directly from the heater and utility of the feature to the consumer Issue A.1 DOE requests comment on without duct connections and includes and other factors DOE deems the definitions currently applicable to electric heaters and unvented gas and appropriate. Id. unvented heaters and whether any of oil heaters. For DHE, the current energy the definitions should be revised, and if Issue A.2 DOE requests comment on conservation standards specified in 10 so, how. Please provide a rationale for whether the definitions applicable to CFR 430.32(i)(2) are based on 11 any suggested change. DOE notes that DHE require any revisions, and if so, product classes divided by equipment floor electric heaters are not currently how those definitions should be revised. type (i.e., wall, floor, or room), heat listed among the other types of heaters Please provide a rationale for any circulation type (i.e., fan or gravity), and included in the definition of a ‘‘primary suggested change. DOE also requests input capacity. Table II.1 lists the heater.’’ DOE understands that floor feedback on whether the sub-category current product classes for DHE. electric heaters have similar heat output definitions currently in place are as the types of heaters listed in the appropriate or whether further TABLE II.1—CURRENT DIRECT HEAT- definition of ‘‘primary heater’’ and may modifications are needed. If these sub- ING EQUIPMENT PRODUCT CLASSES provide the primary source of heat in category definitions need modifying, DOE seeks specific input on how to small dwellings. DOE requests comment DHE Heat on whether floor electric heaters should define these terms. type circulation Input rate, Btu/h be specifically defined and also Issue A.3 DOE requests comment on type whether additional product definitions included in the definition of ‘‘primary Wall .. Fan ...... ≤42,000. heater.’’ are necessary to close any potential gaps >42,000. in coverage between product types. DOE ≤ 2. Vented Heaters Gravity ...... 27,000. also seeks input on whether such >27,000 and ≤46,000. Vented heaters are those products that products currently exist in the market or >46,000. meet the definitions for ‘‘vented home whether they are being planned for Floor All ...... ≤37,000. heating equipment,’’ as codified at 10 introduction. >37,000. CFR 430.2. DOE defines vented heaters Room All ...... ≤20,000. B. Market and Technology Assessment >20,000 and ≤27,000. and the various sub-types of vented ≤ heaters as follows: The market and technology >27,000 and 46,000. (1) ‘‘Vented home heating equipment’’ assessment that DOE routinely conducts >46,000. or ‘‘vented heater’’ means a class of when analyzing the impacts of a home heating equipment, not including potential new or amended energy Issue B.1 DOE requests feedback on furnaces, designed to furnish warmed conservation standard provides the current DHE product classes and air to the living space of a residence, information about the DHE industry that whether changes to these individual directly from the device, without duct will be used in DOE’s analysis product classes and their descriptions connections (except that boots not to throughout the rulemaking process. should be made or whether certain exceed 10 inches beyond the casing may DOE uses qualitative and quantitative classes should be merged or separated. be permitted) and includes: vented wall information to characterize the structure DOE further requests feedback on furnace, vented floor furnace, and of the industry and market. DOE whether combining certain classes vented room heater. identifies manufacturers, estimates could impact product utility by (2) ‘‘Vented floor furnace’’ means a market shares and trends, addresses eliminating any performance-related self-contained vented heater suspended regulatory and non-regulatory initiatives features or impact the stringency of the from the floor of the space being heated, intended to improve energy efficiency current energy conservation standard for taking air for combustion from outside or reduce energy consumption, and these products. DOE also requests this space. The vented floor furnace explores the potential for efficiency comment on separating any of the supplies heated air circulated by gravity improvements in the design and existing product classes and whether it or by a fan directly into the space to be manufacturing of the subject products. would impact product utility by heated through openings in the casing. DOE also reviews product literature, eliminating any performance-related

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features or reduce any compliance TABLE II.2—PREVIOUSLY CONSIDERED (2) Practicability to manufacture, burdens. TECHNOLOGY OPTIONS FOR DIRECT install, and service. If it is determined Issue B.2 DOE seeks information HEATING EQUIPMENT FROM THE that mass production of a technology in regarding any other new product classes APRIL 2010 FINAL RULE AND OCTO- commercial products and reliable it should consider for inclusion in its BER 2016 FINAL DETERMINATION 4— installation and servicing of the analysis. Specifically, DOE requests Continued technology could not be achieved on the information on the performance-related scale necessary to serve the relevant features (e.g., input capacity, equipment Technology options market at the time of the compliance type, heater type, etc.) that provide date of the standard, then that unique consumer utility and data Two-stage and modulating operation technology will not be considered detailing the corresponding impacts on Improved fan or blower motor efficiency further. energy use that would justify separate Increased insulation (3) Impacts on equipment utility or product classes (i.e., explanation for Condensing equipment availability. If a technology Condensing Pulse Combustion why the presence of these performance- is determined to have significant related features would increase energy Air circulation fan Sealed combustion adverse impact on the utility of the consumption). equipment for significant subgroups of 2. Technology Assessment Issue B.3 DOE seeks information on consumers, or result in the the technologies listed in Table II.2 unavailability of any covered equipment In analyzing the feasibility of regarding their applicability to the type with performance characteristics potential new or amended energy current market and how these (including reliability), features, sizes, conservation standards, DOE uses technologies may impact the efficiency capacities, and volumes that are information about existing and past of DHE as measured according to the substantially the same as equipment technology options and prototype DOE test procedure. DOE also seeks generally available in the United States designs to help identify technologies information on how these technologies at the time, it will not be considered that manufacturers could use to meet may have changed since they were further. and/or exceed a given set of energy considered in the October 2016 Final (4) Adverse impacts on health or conservation standards under Determination analysis. Specifically, safety. If it is determined that a consideration. In consultation with DOE seeks information on the range of technology will have significant adverse interested parties, DOE intends to efficiencies or performance impacts on health or safety, it will not develop a list of technologies to characteristics that are currently be considered further. consider in its analysis. That analysis available for each technology option. will likely include a number of the 10 CFR part 430, subpart C, appendix A, Issue B.4 DOE seeks comment on sections 4(a)(4) and 5(b). technology options DOE previously other technology options that it should considered during its most recent consider for inclusion in its analysis. Technology options identified in the rulemaking for DHE. A complete list of DOE is particularly interested in technology assessment are evaluated those prior options appears in Table II.2. information for any potential new against these criteria using DOE DOE has conducted a preliminary technology options regarding their analyses and inputs from interested review and did not identify any new market adoption, costs, and any parties (e.g., manufacturers, trade options. concerns with incorporating them into organizations, and energy efficiency products (e.g., impacts on consumer advocates). Technologies that pass TABLE II.2—PREVIOUSLY CONSIDERED utility, potential safety concerns, through the screening analysis are TECHNOLOGY OPTIONS FOR DIRECT manufacturing/production/ referred to as ‘‘design options’’ in the HEATING EQUIPMENT FROM THE implementation issues). engineering analysis. Technology APRIL 2010 FINAL RULE AND OCTO- options that fail to meet one or more of BER 2016 FINAL DETERMINATION 4 C. Screening Analysis the four criteria are eliminated from The purpose of the screening analysis consideration. Technology options is to evaluate the technologies that Additionally, DOE notes that the four improve equipment efficiency to screening criteria do not directly Increased heat exchanger surface area determine which technologies will be address the proprietary status of Multiple flues technology options. DOE only considers Multiple turns in flue eliminated from further consideration Direct vent (concentric) and which will be passed to the potential efficiency levels achieved Increased heat transfer coefficient engineering analysis for further through the use of proprietary designs Electronic ignition consideration. in the engineering analysis if they are Thermal vent damper DOE determines whether to eliminate not part of a unique pathway to achieve Electrical vent damper certain technology options from further the efficiency level (i.e., if there are Power burner consideration based on the following other non-proprietary technologies Induced draft criteria: capable of achieving the same efficiency (1) Technological feasibility. level). 4 See chapter 3, section 3.3.2.2 in the April 2010 Technologies that are not incorporated Table II.3 summarizes the technology final rule technical support document (TSD) published during the rulemaking process, in commercial products or in working options that DOE screened out in the document #149 on https://regulations.gov in docket prototypes will not be considered April 2010 final rule, and the applicable ID EERE–2006–STD–0129. further. screening criteria.

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TABLE II.3—PREVIOUSLY SCREENED OUT TECHNOLOGY OPTIONS FROM THE APRIL 2010 FINAL RULE 5

EPCA Criteria (X = basis for screening out) Screened technology option Practicability to Adverse impacts Technological manufacture, Adverse impact on on health and feasibility install, and service product utility safety

Increased heat transfer coefficient ...... X Power burner ...... X Condensing Pulse Combustion ...... X Improved fan or blower motor efficiency ...... X

Issue C.1 DOE requests feedback on costs of achieving increases in energy appropriate. If this approach is not what impact, if any, the screening efficiency levels, without regard to the appropriate, what alternative criteria described in this section would particular design options used to approaches should DOE consider using have on each of the technology options achieve such increases; and (3) the cost- and why? 6 listed in Table II.2 with respect to DHE. assessment (or reverse engineering) 1. Baseline Efficiency Levels Similarly, DOE seeks information approach, which provides ‘‘bottom-up’’ regarding how these same criteria would manufacturing cost assessments for For each product class that is affect any other technology options not achieving various levels of increased analyzed, DOE selects a baseline model already identified in this document with efficiency, based on detailed cost data as a reference point against which any respect to their potential use in DHE. for parts and material, labor, shipping/ changes resulting from new or amended Issue C.2 With respect to the packaging, and investment for models energy conservation standards can be screened out technology options listed that operate at particular efficiency measured. The baseline model in each in Table II.3, DOE seeks information on levels. product class represents the whether these options should, based on In the analysis for the April 2010 final characteristics of common or typical current and projected assessments rule, DOE analyzed four product classes products in that class. Typically, a regarding each of them, remain screened that were representative of the 11 total baseline model is one that just meets the out under the screening criteria classes. Specifically, for each type of current minimum energy conservation described in this section. With respect DHE (i.e., wall fan, wall gravity, floor, standards and provides basic consumer to each of these technology options, room), DOE selected one utility. what steps, if any, could be (or have ‘‘representative’’ input range for DOE uses baseline models for already been) taken to facilitate the analysis and applied that analysis across comparison in several phases of the introduction of each option as a means all other input rate ranges for the given analyses, including the engineering to improve the energy performance of type of DHE. DOE developed a cost- analysis, life-cycle cost (‘‘LCC’’) DHE? efficiency relationship for each of these analysis, payback period (‘‘PBP’’) analyzed representative product classes analysis, and national impact analysis D. Engineering Analysis that were used as the input for the (‘‘NIA’’). In the engineering analysis, to The engineering analysis estimates downstream analyses conducted in determine the changes in price to the the cost-efficiency relationship of support of that rulemaking. See chapter consumer that result from amended products at different levels of increased 5 of the April 2010 final rule TSD for standards, DOE compares the price of a energy efficiency (‘‘efficiency levels’’). the cost-efficiency curves developed in baseline model to the price of a model This relationship serves as the basis for that rulemaking. at each higher efficiency level. the cost-benefit calculations for Issue D.1 DOE requests comment on If it determines that a rulemaking is consumers, manufacturers, and the whether it is necessary to individually necessary, consistent with this Nation. In determining the cost- analyze all 11 product classes, or analytical approach, DOE tentatively efficiency relationship, DOE estimates whether the approach of analyzing a plans to consider the current minimum the change in manufacturer production representative sub-set of product classes energy conservations standards (which cost (‘‘MPC’’) associated with increasing is appropriate for any potential future went into effect April 16, 2013) to the efficiency of products above the DHE energy conservation standards establish the baseline efficiency levels baseline, up to the maximum rulemaking. For example, analysis on for each product class. The current technologically feasible (‘‘max-tech’’) the gas wall fan less than or equal to standards for each product class are efficiency level for each product class. 42,000 Btu/h product classes may not be based on DHE type (wall, floor, or DOE historically has used the necessary if the analysis on the room), heat circulation type (fan or following three methodologies to corresponding gas wall fan greater than gravity), and input capacity. The current generate incremental manufacturing 42,000 Btu/h product classes is standards for DHE are found at 10 CFR costs and establish efficiency levels applicable to both product classes. 430.32(i)(2). (‘‘ELs’’) for analysis: (1) The design- Additionally, DOE welcomes comment Issue D.2 DOE requests feedback on option approach, which provides the on potential approaches to apply the whether using the current established incremental costs of adding to a baseline analyzed representative product class energy conservation standards for DHE model design options that will improve results to the other product classes, are appropriate baseline efficiency its efficiency; (2) the efficiency-level including the approach used for the levels for DOE to apply to each product approach, which provides the relative April 2010 final rule. If it is necessary class in evaluating whether to amend to individually analyze each of the 11 6 5 See chapter 4, section 4.2.2 in the April 2010 product classes (or more than the 11 See chapter 5, section 5.3 in the April 2010 final final rule TSD published during the rulemaking rule TSD published during the rulemaking process, process, document #149 on https://regulations.gov classes), please provide information on document #149 on https://regulations.gov in docket in docket ID EERE–2006–STD–0129. why aggregating certain products is not ID EERE–2006–STD–0129.

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the current energy conservation relationship between energy use and incorporated in a model. In some cases, standards for these products. DOE input capacity. models at the max-tech efficiency level requests data and suggestions to 2. Maximum Available and Maximum are not commercially available because, evaluate the baseline efficiency levels in Technologically Feasible Levels although the level is technically order to better evaluate the potential for achievable, manufacturers have amending energy conservation As part of DOE’s analysis when determined that it is not economically considering potential amended standards for these products. feasible (either for the manufacturer to standards, DOE determines the produce or for consumers to purchase). Issue D.3 DOE requests feedback on maximum available efficiency level and the appropriate baseline efficiency the maximum technologically feasible However, DOE seeks to determine the levels for any newly analyzed product (‘‘max-tech’’) efficiency level for each max-tech level for purposes of its classes that are not currently in place or product class analyzed. The maximum analyses. The current maximum for any contemplated combined or available efficiency level is the highest- available efficiencies for the 11 existing separated product classes, as discussed efficiency model currently available on product classes are included in Table in section II.B.1 of this document. For the market for that class. The max-tech II.4, along with the maximum available product classes that would be newly efficiency level represents the efficiencies from the April 2010 final analyzed (if any), DOE requests energy theoretical maximum possible efficiency rule and the October 2016 final use data to develop a baseline if all available design options are determination.

TABLE II.4—MAXIMUM AVAILABLE EFFICIENCY LEVELS—CURRENT AND PREVIOUS RULEMAKINGS

AFUE

DHE type Heat circulation type Input rate, Btu/h October April 2010 * 2016 ** Current ***

Wall ...... Fan ...... ≤42,000 ...... 83 92 93 >42,000 ...... † 80 80 80 Gravity ...... ≤27,000 ...... 80 80 72 >27,000 and ≤46,000 ...... † 69 69 69 >46,000 ...... 69 70 70 Floor ...... All ...... ≤37,000 ...... 57 57 57 >37,000 ...... † 58 58 58 Room ...... All ...... ≤20,000 ...... 59 71 71 >20,000 and ≤27,000 ...... 63 66 66 >27,000 and ≤46,000 ...... † 81 68 68 >46,000 ...... 70 70 70 * Gas Appliance Manufacturers Associated Directory for Direct Heating Equipment downloaded March 2, 2009. ** Combination of Air-Conditioning, Heating, & Refrigeration Institute (AHRI) and DOE’s Compliance Certification Management System (CCMS) databases downloaded on July 16, 2015. *** Combination of AHRI and CCMS databases download on September 10, 2018. † Representative product classes analyzed in the April 2010 final rule.

In the April 2010 final rule, DOE improved heat exchanger. 75 FR 20112, manufacturing cost increase for determined max-tech efficiency levels 20145–20146 (April 16, 2010). condensing units. Manufacturers also using the technology options available In the October 2016 final indicated that shipments were so low as at that time. For gas wall fan DHE with determination, DOE noted that to be negligible, and DOE noted that an input rate over 42,000 Btu/h, DOE condensing gas wall fan DHE models only one manufacturer produced a identified a max-tech efficiency level with input rates at or below 42,000 Btu/ condensing gas wall fan DHE at that design with induced draft combustion, h had become available, and DOE time. DOE stated in the final resulting in an AFUE of 80 percent. For considered this the max-tech level for determination that manufacturers would gas wall gravity DHE with an input rate gas wall fan DHE. Based on information need to make substantial investments in over 27,000 Btu/h and up to 46,000 Btu/ obtained during manufacturer order to produce these units on a scale h, DOE identified 70 percent AFUE as interviews and a manufacturer large enough to support a Federal a theoretical max-tech level, which was production cost found through a minimum standard and that severe manufacturer impacts would be achievable with an improved heat teardown analysis performed for the expected if an energy conservation exchanger design and electronic proposed determination (81 FR 21276, standard were adopted at a level met ignition. For gas floor DHE with an 21280 (April 11, 2016)), DOE determined that condensing technology through use of condensing technology. input rate over 37,000 Btu/h, DOE Therefore, DOE concluded the identified the max-tech efficiency level was not economically justified for gas wall fan DHE at that time. 81 FR 71325, condensing technology option would as 58 percent AFUE, which DOE stated not be economically justified at that could be reached using an improved 71328 (Oct. 17, 2016). During manufacturer interviews conducted time when analyzed for the Nation as a heat exchanger design. For gas room leading up to the proposed whole. Id. In DOE’s preliminary DHE with an input rate over 27,000 Btu/ determination, manufacturers indicated research for this RFI, it found that 2 out h and up to 46,000 Btu/h, DOE that condensing models are significantly of the 4 manufacturers of gas wall fan identified a theoretical max-tech more expensive to produce than non- DHE currently make products efficiency level of 83 percent AFUE, condensing models, which DOE incorporating condensing technology. which manufacturers could achieve confirmed through its teardown Issue D.4 DOE seeks input on using an electronic ignition and analysis, which showed a 23 percent whether the maximum available

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efficiency levels are appropriate and development efforts to implement each go through distributors to contractors, technologically feasible for design option, and manufacturing/ and then to consumers as follows: consideration as possible energy production impacts. Manufacturer → Wholesaler → conservation standards for the products Issue D.8 DOE requests comment on Mechanical Contractor → Consumer at issue, and if not, why not. DOE also whether certain design options may not In new home applications, most sales seeks input on whether other maximum be applicable to (or incompatible with) go through distributors to contractors efficiency levels are possible with specific product classes. hired by the builder as follows: technologies, or combinations of To account for manufacturers’ non- → → technologies, not currently incorporated Manufacturer Wholesaler production costs and profit margin, DOE → in available designs. Mechanical Contractor General → Issue D.5 DOE seeks feedback on applies a non-production cost multiplier Contractor Consumer what design options would be (the manufacturer mark-up) to the MPC. Issue E.1 DOE requests information incorporated at a max-tech efficiency The resulting manufacturer selling price on the existence of any distribution level, and the efficiencies associated (‘‘MSP’’) is the price at which the channels that are used to distribute the with those levels. As part of this manufacturer distributes a unit into products at issue into the market. DOE request, DOE also seeks information as commerce. For the April 2010 final rule, also requests data on the fraction of DHE to whether there are limitations on the DOE used a manufacturer mark-up of sales in the residential sector that go use of certain combinations of design 1.35 for all DHE. See chapter 5 of the through any identified channels. options. April 2010 final rule TSD. Issue D.9 DOE requests feedback on 2. Mark-Ups 3. Manufacturer Production Costs and whether a manufacturer mark-up of 1.35 To develop mark-ups for the parties Manufacturing Selling Price is appropriate for all DHE. involved in the distribution of the As described at the beginning of this E. Mark-Up Analysis equipment, DOE plans to primarily section, the main outputs of the utilize: (1) The Heating, Air engineering analysis are cost-efficiency The mark-ups analysis develops Conditioning & Refrigeration relationships that describe the estimated appropriate mark-ups (e.g., for Distributors International (‘‘HARDI’’) increases in manufacturer production wholesalers, mechanical contractors, 2013 Profit Report 9 (for wholesalers) cost (MPC) associated with higher- general contractors) in the distribution and 3. U.S. Census Bureau 2012 efficiency products for the analyzed chain (i.e., how the products are Economic Census data 10 on the product classes. For the April 2010 final distributed from the manufacturer to the residential building construction rule, DOE developed the cost-efficiency consumer) and sales taxes to convert the industry (for general contractors and relationships by estimating the manufacturer sales prices (‘‘MSP’’) mechanical contractors). DOE also plans efficiency improvements and costs derived in the engineering analysis to to use the 2005 Air Conditioning associated with incorporating specific consumer prices, which are then used in Contractors of America’s (‘‘ACCA’’) design options into the assumed the LCC and PBP analyses and other Financial Analysis on the Heating, baseline model for each analyzed analyses. At each step in the Ventilation, Air-Conditioning, and product class. 75 FR 20112, 20147– distribution channel, companies mark Refrigeration (‘‘HVACR’’) contracting 20149 (April 16, 2010). up the price of the equipment to cover industry 11 to disaggregate the Issue D.6 DOE requests feedback on business costs and profit margin. mechanical contractor mark-ups into how manufacturers would incorporate replacement and new construction 1. Distribution Channels the technology options listed in Table markets. DOE will also consider updates II.2 to increase energy efficiency in DHE In generating end-user price inputs for to any of these materials that may beyond the baseline. This includes the LCC analysis and NIA, DOE must publish during DOE’s evaluation. information on the order in which identify distribution channels (i.e., how In addition to the mark-ups, DOE will manufacturers would incorporate the the products are distributed from the derive State and local taxes from data different technologies to incrementally manufacturer to the consumer) and provided by the Sales Tax improve the efficiencies of products. estimate relative sales volumes through Clearinghouse.12 These data represent DOE also requests feedback on whether each channel. Two different markets weighted-average taxes that include the increased energy efficiency would exist for DHE: (1) Replacements and county and city rates. DOE will derive lead to other design changes that would new owners,7 and (2) new construction. shipment-weighted-average tax values not occur otherwise. DOE is also DOE intends to use similar distribution for each region considered in the interested in information regarding any channels in its analysis as found in the analysis. potential impact of design options on a April 2010 final rule. DHE is mainly a Issue E.2 DOE requests recent data manufacturer’s ability to incorporate replacement product.8 For replacement and recommendations regarding data additional functions or attributes in and new owner applications, most sales sources to establish the mark-ups for the response to consumer demand. Issue D.7 DOE also seeks input on 7 9 Heating, Air Conditioning & Refrigeration the change in MPC associated with New owners are defined as existing buildings that acquire a DHE for the first time during the Distributors International (HARDI), 2013 HARDI incorporating each particular design analysis period. An example of new owner for DHE Profit Report (Available at: http://hardinet.org/) option. Specifically, DOE is interested would be someone with an addition to an existing (Last accessed Oct. 2, 2018). in whether and how the costs estimated house where it would not be feasible to extend the 10 U.S. Census Bureau, 2012 Economic Census for design options in the April 2010 house’s primary heating system to the new space. Data (Available at: http://www.census.gov/econ/) 8 The Air-Conditioning, Heating, and (Last accessed Sept. 12, 2018). final rule have changed since the time Refrigeration Institute (AHRI) stated that less than 11 Air Conditioning Contractors of America of that analysis. DOE also requests 5 percent of DHE sales are for new construction (ACCA), Financial Analysis for the HVACR information on the investments projects. AHRI, Comment #7 for RFI for Energy Contracting Industry (2005) (Available at: http:// necessary to incorporate specific design Conservation Standards for Energy Conservation www.acca.org/store/) (Last accessed Oct. 2, 2018). Standards for Direct Heating Equipment and Pool 12 Sales Tax Clearinghouse Inc., State Sales Tax options, including, but not limited to, Heaters (April 27, 2015) (Available at: https:// Rates Along with Combined Average City and costs related to new or modified tooling www.regulations.gov/document?D=EERE-2015-BT- County Rates. 2018 (Available at; http://thestc.com/ (if any), materials, engineering, and STD-0003-0007) (Last accessed Oct. 2, 2018). STrates.stm) (Last accessed Oct. 2, 2018).

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parties involved with the distribution of Northwest,17 2015 Residential of the blower (when applicable), DHE. Statewide Baseline Study of New York because heat from the blower State,18 2006 California Commercial contributes to heating the housing unit. F. Energy Use Analysis End-Use Survey,19 and 2009 Residential A large fraction of DHE are used as DOE conducts an energy use analysis Appliance Saturation Study 20) to secondary heating equipment; therefore, to identify how products are used by compare these to the RECS 2015 and DOE intends to adjust the house heating consumers, and thereby determine the CBECS 2012 data for the corresponding load for households that use the direct energy savings potential of energy region. heating equipment as secondary heating efficiency improvements. DOE uses the Issue F.1 DOE requests comment on equipment by using the reported annual energy consumption and energy- the overall method to determine the fraction of heating energy consumption savings potential in the LCC and PBP building sample for direct heating attributable to secondary heating analysis to establish the operating costs equipment and whether other factors products in RECS 2015. To complete the savings at various product efficiency should be considered in developing the analysis, DOE plans to calculate the levels. DOE will estimate the annual building sample. In addition, DOE energy consumption of more energy energy consumption of direct heating requests information on the installation efficient DHE alternatives replacing the equipment at specified energy efficiency applications of DHE, including, but not existing DHE. levels across a range of applications, limited to the fraction of DHEs that are Issue F.2 DOE requests comment on household types, and climate zones. installed in residential and commercial the overall method to determine energy The annual energy consumption applications, as well as how many DHE use of direct heating equipment and if includes use of natural gas, liquefied are typically installed per building. other factors should be considered in petroleum gas (LPG (i.e., propane)), and 2. Energy Use Calculations developing the energy use methodology. electricity. To determine the site energy G. Life-Cycle Cost and Payback Period 1. Sample Development consumption by the DHEs installed in Analysis DOE intends to base the energy use the building, DOE intends to use a DOE plans to conduct LCC and PBP analysis on key characteristics from the methodology based on the energy use analyses to evaluate the economic Energy Information Administration’s equations from the DOE test procedure impacts on residential and commercial (‘‘EIA’’) 2015 Residential Energy for DHEs (10 CFR part 430, subpart B, consumers of potential standards for Consumption Survey (‘‘RECS’’) 13 for the appendix O, section 4.6). For each DHEs. The effect of new or amended subset of residential buildings that use household or building in the sample, standards on residential and DHEs. DOE also plans to include in its DOE plans to use RECS 2015 and commercial consumers usually involves analysis DHE used in the commercial CBECS 2012 reported heating energy a reduction in operating cost and an sector using EIA’s 2012 Commercial consumption to estimate the heating increase in purchase cost. Building Energy Consumption Survey load of the housing unit or building.21 DOE intends to analyze the potential (‘‘CBECS’’).14 The estimation of heating loads requires for variability by performing the LCC RECS and CBECS data include data on the existing DHE characteristics and PBP calculations on a information on the DHE type, physical (such as DHE type, fuel type, equipment representative sample of residential and characteristics of buildings, fuels used, size, and efficiency of the DHE). DOE commercial consumers. DOE plans to energy consumption and expenditures, intends to assign DHE characteristics of utilize the sample of buildings and other relevant characteristics.15 existing systems based on the developed for the energy use analysis. Based on RECS 2015 and CBECS 2012 distributions of DHE provided in DOE plans to model uncertainty in data, DOE will develop a representative historical versions of the AHRI model many of the inputs to the LCC and PBP population of buildings for DHE. In certification directory 22 and any other analysis using Monte Carlo simulation addition, DOE intends to review other available historical data. The estimation and probability distributions. As a data sets (e.g., data from the 2016 of heating loads also requires result, the LCC and PBP results will be Residential Building Stock Assessment calculating the electricity consumption presented as distributions of impacts for the Northwest,16 2014 Commercial compared to the no-new-standards case Building Stock Assessment for the 17 Northwest Energy Efficiency Alliance (NEEA), (i.e., the case without amended Commercial Building Stock Assessment (2014) (Available at: https://dev.neea.org/data/ standards). 13 Energy Information Administration (EIA), 2015 commercial-building-stock-assessments) (Last Inputs to the LCC and PBP analysis Residential Energy Consumption Survey (RECS) accessed Oct. 2, 2018). are categorized as: (1) Inputs for (Available at: https://www.eia.gov/consumption/ 18 New York State Energy Research and establishing the purchase expense, residential/) (Last accessed Oct. 2, 2018). Development Authority (NYSERDA), Residential 14 Energy Information Administration (EIA), 2012 Statewide Baseline Study of New York State (July otherwise known as the total installed Commercial Building Energy Consumption Survey 2015) (Available at: https://www.nyserda.ny.gov/ cost, and (2) inputs for calculating the (CBECS) (Available at: http://www.eia.gov/ About/Publications/Building-Stock-and-Potential- operating costs. Each type of input is consumption/commercial/) (Last accessed Oct. 2, Studies/Residential-Statewide-Baseline-Study-of- discussed in the paragraphs that follow. 2018). New-York-State) (Last accessed Oct. 2, 2018). 15 From RECS 2015, DOE intends to use 19 California Energy Commission (CEC), 2006 1. Total Installed Cost households listed as using primary gas heating California Commercial End-Use Survey (2006) equipment from ‘‘built-in room heater burning gas, (Available at: http://www.energy.ca.gov/ceus/2006_ The primary inputs for establishing oil, or kerosene’’ (138 home sample is estimated to enduse.html) (Last accessed Oct. 2, 2018). the total installed cost are the baseline represent 2.8 million homes in 2015) and ‘‘built-in 20 California Energy Commission (CEC), 2009 customer price, incremental customer floor/wall pipeless furnace’’ (41 home sample is Residential Appliance Saturation Study (RASS) price increases resulting from a estimated to represent 0.8 million homes in 2015) (2009) (Available at: http://www.energy.ca.gov/ and as secondary gas heating equipment from appliances/rass/) (Last accessed Oct. 2, 2018). potential standard, and installation ‘‘some other equipment’’ (221 home sample is 21 The heating load represents the amount of costs. Baseline prices and standard-level estimated to represent 4.2 million homes in 2015). heating required to keep a housing unit comfortable price increases will be determined by 16 Northwest Energy Efficiency Alliance (NEEA), throughout an average year. applying mark-ups to manufacturer Residential Building Stock Assessment (2016) 22 AHRI, Directory of Certified Product (Available at: https://dev.neea.org/data/residential- Performance for Direct Heating Equipment selling price estimates and sales tax. building-stock-assessment) (Last accessed Oct. 2, (Available at: https://www.ahridirectory.org/) (Last The installation cost is added to the 2018). accessed Oct. 2, 2018). customer price to arrive at a total

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installed cost. DOE intends to develop is not aware of any information about a develop a Weibull probability installation costs using the most recent rebound effect for DHE. distribution to characterize DHE RS Means data available.23 DOE also Issue G.2 DOE seeks comments and lifetime.25 intends to use regional labor costs to data on any rebound effect that may be Issue G.6 DOE requests product more accurately estimate installation associated with more-efficient DHE. lifetime data and information on costs by applying the appropriate The repair cost is the expense to whether product lifetime varies based regional labor cost from RS Means to repair or replace components of the on DHE product class, application, or each sampled DHE installation. covered product that have failed. The efficiency. In conducting its analyses, DOE maintenance cost is the expense of DOE measures LCC and PBP impacts intends to utilize an installation cost regular scheduled product maintenance of potential standard levels relative to a methodology that is customized for each to ensure the continued operation of the no-new-standards case that reflects the DHE product class. For DHEs in new covered product over time. These costs likely market in the absence of amended owner installations or new construction, cover all labor and material costs standards. DOE plans to develop DOE plans to include costs such as associated with the repair or efficiency market shares (i.e., the adding gas piping, putting the DHE in maintenance. DOE intends to develop distribution of product shipments by place, and additional set-up. For repair and maintenance costs using the efficiency) for DHEs, for the anticipated replacement cases, in addition to the most recent RS Means data available 24 year in which compliance with any costs considered for new installations, and manufacturer literature. potential amended standards would be DOE also plans to include the DOE intends to assess whether repair required. DOE is not aware of any installation cost associated with or maintenance costs vary with shipment data to estimate the market disconnecting and removing the old equipment efficiency and product class. shares of different DHE energy DHE, as well as removal/disposal and In addition, DOE plans to consider the efficiency levels in the no-new- permit fees, if applicable. In addition, cases in which the equipment is covered standards case. DOE is particularly DOE intends to assess whether by warranty, service, and/or interested in receiving such data. If no installation costs vary with equipment maintenance agreements. More market share data become available, efficiency, including design options that specifically, DOE intends to account for DOE intends to use data on the number require a new electrical outlet (many the maintenance cost associated with of DHE models at different energy existing DHE installations currently do the manufacturer-recommended annual efficiency levels, as reported in DOE’s not have electrical power input) or maintenance prior to the heating season. compliance certification database,26 condensing DHE units that require new DOE will determine the repair cost historical versions of the AHRI model PVC venting and condensate using an approach that reflects the cost certification directory,27 and from withdrawal. and the service life of the components manufacturer literature. Issue G.1 DOE seeks input on any that are likely to fail. DOE plans to Issue G.7 DOE requests information available installation cost data for DHEs. consider component repair costs that on the DHE market, including but not DOE also seeks input on the approach might fail during the lifetime of the limited to, the current market share by it intends to use to develop DHE product, including the pilot ignition, different efficiency level and by product installation costs, specifically, its electronic ignition, circulating blower, class, similar historical data, and intention to use the most recent RS and induced draft fan. information on expected future trends Means Mechanical Cost Data. Issue G.3 DOE requests feedback and in the efficiency of DHEs. data on whether maintenance costs 2. Operating Costs differ in comparison to the baseline H. Shipments Analysis The primary inputs for calculating the maintenance costs for any of the specific DOE develops shipments forecasts of operating costs of DHEs are energy technology options listed in Table II.2 DHE to calculate the national impacts of consumption, equipment efficiency, and Table II.3. To the extent that these potential amended energy conservation energy prices, maintenance and repair costs differ, DOE seeks supporting data standards on energy consumption, net costs, equipment lifetime, and discount and the reasons for those differences. present value (‘‘NPV’’), and future rates. Both equipment lifetime and Issue G.4 DOE requests information manufacturer cash flows. DOE discount rates are used to calculate the and data on the frequency of repair and shipments projections are based on present value of future operating costs. repair costs by product class for the available historical data broken out by The product energy consumption is technology options listed in Table II.2 product class, input capacity, and the site energy use associated with and Table II.3. DOE is also interested in efficiency. Current sales estimates allow providing space heating to the room of whether consumers simply replace the for a more accurate model that captures a building. DOE intends to utilize the products when they fail as opposed to recent trends in the market. From the site energy use calculation methodology repairing them. April 2010 final rule, DOE has DHE described in section II.F of this Issue G.5 DOE also seeks comment historical shipment data from AHRI for document to determine product energy on the extent to which repair or use. DOE also plans to assess the maintenance costs are covered by 25 A Weibull probability distribution is a potential applicability of the ‘‘rebound warranty, service, and/or maintenance continuous distribution function typically used in effect’’ in the energy consumption for reliability engineering and equipment failure agreements. analysis. If the data are available, DOE also plans DHE. A rebound effect occurs when a Equipment lifetime is the age at to take into account differences in DHE lifetime product that is made more efficient is which a unit is retired from service. based on usage and application. used more intensively, so that the DOE intends to conduct a literature 26 U.S. Department of Energy, Compliance expected energy savings from the review of DHE lifetime data together Certification Database: Unfired Hot Water Storage efficiency improvement may not fully Tanks—Commercial (Available at: https:// with any stakeholder lifetime data to www.regulations.doe.gov/certification-data/ materialize. However, at this time, DOE products.html) (Last accessed Oct. 2, 2018). 24 RS Means, 2018 Facilities Maintenance & 27 AHRI, Directory of Certified Product 23 RS Means, 2018 Mechanical Cost Data Repair Cost Data (Available at: https:// Performance for Direct Heating Equipment (Available at: https://www.rsmeans.com/products/ www.rsmeans.com/products/books.aspx) (Last (Available at: https://www.ahridirectory.org/) (Last books.aspx) (Last accessed Oct. 2, 2018). accessed Oct. 2, 2018). accessed Oct. 2, 2018).

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wall furnaces from 1990 to 1998 and gravity wall furnaces and by input An example table of the types of data from 2000 to 2006, for floor furnaces capacity.30 requested for 2008–2018 shipments can from 1990 to 2007, and for room heaters Issue H.1 DOE requests annual sales be found in Table II.5. Interested parties from 1990 to 2005.28 29 DOE has limited data (i.e., number of shipments) for each are also encouraged to provide disaggregated shipments for fan and DHE product class from 2008–2018. additional shipment data as may be relevant including data before 2008. TABLE II.5—SUMMARY TABLE OF SHIPMENTS—RELATED DATA REQUESTS

Annual shipments Heat circulation (number sold) Equipment type type Input rate, Btu/h 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Wall ...... Fan ...... ≤42,000. >42,000. Gravity ...... ≤27,000. >27,000 and ≤46,000. >46,000. Floor ...... All ...... ≤37,000. >37,000. Room ...... All ...... ≤20,000. >20,000 and ≤27,000. >27,000 and ≤46,000. >46,000.

If disaggregated fractions of annual energy conservation standards on burden. In addition to energy sales are not available at the product subgroups of manufacturers of covered conservation standards, other type level, DOE requests more products, including small business regulations can significantly affect aggregated fractions of annual manufacturers. DOE uses the Small manufacturers’ financial operations. shipments at the category level. Business Administration’s (‘‘SBA’’) Multiple regulations affecting the same Issue H.2 If available, DOE requests small business size standards to manufacturer can strain profits and lead the same information in Table II.5 by determine whether manufacturers companies to abandon product lines or efficiency. qualify as small businesses, which are markets with lower expected future I. Manufacturer Impact Analysis listed by the applicable North American returns than competing products. For Industry Classification System these reasons, DOE conducts an analysis The purpose of the manufacturer (‘‘NAICS’’) code.31 Manufacturing of of cumulative regulatory burden as part impact analysis (‘‘MIA’’) is to estimate consumer DHE is classified under of its rulemakings pertaining to the financial impact of new or amended NAICS 333414, ‘‘Heating Equipment appliance efficiency. energy conservation standards on (except Warm Air Furnaces) manufacturers of DHE, and to evaluate Issue I.1 To the extent feasible, DOE Manufacturing,’’ and the SBA sets a the potential impact of such standards seeks the names and contact threshold of 500 employees or less for on direct employment and information of any domestic or foreign- a domestic entity to be considered as a manufacturing capacity. The MIA based manufacturers that distribute DHE small business. This employee includes both quantitative and in the United States. threshold includes all employees in a qualitative aspects. The quantitative Issue I.2 DOE identified small business’s parent company and any part of the MIA primarily relies on the businesses as a subgroup of other subsidiaries. Government Regulatory Impact Model manufacturers that could be (‘‘GRIM’’), an industry cash-flow model One aspect of assessing manufacturer disproportionally impacted by amended adapted for each product in this burden involves examining the energy conservation standards. DOE analysis, with the key output being the cumulative impact of multiple DOE requests the names and contact industry net present value (‘‘INPV’’), standards and the product-specific information of small business which is used to assess the financial regulatory actions of other Federal manufacturers, as defined by the SBA’s impacts of a potential standard. The agencies that affect the manufacturers of size threshold, that distribute DHE qualitative part of the MIA addresses the a covered product or equipment. While products in commerce in the United potential impacts of energy conservation any one regulation may not impose a States. In addition, DOE requests standards on manufacturing capacity significant burden on manufacturers, comment on any other manufacturer and industry competition, as well as the combined effects of several existing subgroups that could be factors such as product characteristics, or impending regulations may have disproportionally impacted by amended impacts on particular subgroups of serious consequences for some energy conservation standards for DHE. firms, and important market and manufacturers, groups of manufacturers, DOE requests feedback on any potential product trends. or an entire industry. Assessing the approaches that could be considered to As part of the MIA, DOE intends to impact of a single regulation may address impacts on manufacturers, analyze impacts of potential amended overlook this cumulative regulatory including small businesses.

28 AHRI, AHRI Shipments Data, March 3, 2008. 29 AHRI, AHRI Floor Furnace Supplemental kBtu/h and wall fan furnace above over 42 kBtu/ (Note: 1990–2006 Wall furnaces data disaggregated Shipments Data, March 11, 2008. h only). by vented wall furnaces and direct-vent wall 30 AHRI, AHRI Wall Furnace Supplemental 31 Available online at: http://www.sba.gov/sites/ furnaces). Shipments Data, May 19, 2008. (Note: 2002–2006 default/files/Size_Standards_Table.pdf. shipments for wall gravity furnace over 27 to 46

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Issue I.3 DOE requests information Technologies Office staff only. Your viewable as long as it does not include regarding the cumulative regulatory contact information will not be publicly any comments. burden impacts on manufacturers of viewable except for your first and last Include contact information each time DHE associated with: (1) Other DOE names, organization name (if any), and you submit comments, data, documents, standards applying to different products submitter representative name (if any). and other information to DOE. If you that these manufacturers may also make If your comment is not processed submit via postal mail or hand delivery, and (2) product-specific regulatory properly because of technical please provide all items on a CD, if actions of other Federal agencies. DOE difficulties, DOE will use this feasible, in which case it is not also requests comment on its information to contact you. If DOE necessary to submit printed copies. No methodology for computing cumulative cannot read your comment due to telefacsimilies (faxes) will be accepted. regulatory burden and whether there are technical difficulties and cannot contact Comments, data, and other any flexibilities it can consider that you for clarification, DOE may not be information submitted to DOE would reduce this burden while able to consider your comment. electronically should be provided in remaining consistent with the However, your contact information PDF (preferred), Microsoft Word or requirements of EPCA. will be publicly viewable if you include Excel, WordPerfect, or text (ASCII) file it in the comment or in any documents J. Other Energy Conservation Standards format. Provide documents that are not attached to your comment. Any Topics secured, written in English, and free of information that you do not want to be any defects or viruses. Documents 1. Market Failures publicly viewable should not be should not contain special characters or In the field of economics, a market included in your comment, nor in any any form of encryption, and, if possible, failure is a situation in which the document attached to your comment. they should carry the electronic market outcome does not maximize Persons viewing comments will see only signature of the author. societal welfare. Such an outcome first and last names, organization Campaign form letters. Please submit would result in unrealized potential names, correspondence containing campaign form letters by the originating welfare. DOE welcomes comment on comments, and any documents organization in batches of between 50 to any aspect of market failures, especially submitted with the comments. 500 form letters per PDF or as one form those in the context of amended energy Do not submit to http:// letter with a list of supporters’ names conservation standards for DHE. www.regulations.gov information for compiled into one or more PDFs. This which disclosure is restricted by statute, reduces comment processing and 2. Market-Based Approaches to Energy such as trade secrets and commercial or posting time. Conservation Standards financial information (hereinafter Confidential Business Information. As part of its regulatory reform efforts, referred to as Confidential Business Pursuant to 10 CFR 1004.11, any person DOE published a request for information Information (‘‘CBI’’)). Comments submitting information that he or she discussing key issues and requesting submitted through http:// believes to be confidential and exempt feedback on market-based approaches to www.regulations.gov cannot be claimed by law from public disclosure should energy conservation standards. 82 FR as CBI. Comments received through the submit via email, postal mail, or hand 56181 (Nov. 28, 2017). DOE requests website will waive any CBI claims for delivery two well-marked copies: one comment on how market-based the information submitted. For copy of the document marked approaches to energy conservation information on submitting CBI, see the ‘‘confidential’’ including all the standards might impact standards for Confidential Business Information information believed to be confidential, these products, and specifically seeks section. and one copy of the document marked comment on any considerations with DOE processes submissions made ‘‘non-confidential’’ with the information respect to DHE. through http://www.regulations.gov believed to be confidential deleted. In addition to the issues identified before posting. Normally, comments Submit these documents via email or on earlier in this document, DOE welcomes will be posted within a few days of a CD, if feasible. DOE will make its own comment on any other aspect of energy being submitted. However, if large determination about the confidential conservation standards for DHE not volumes of comments are being status of the information and treat it already addressed by the specific areas processed simultaneously, your according to its determination. identified in this document. comment may not be viewable for up to Factors of interest to DOE when several weeks. Please keep the comment evaluating requests to treat submitted III. Submission of Comments tracking number that http:// information as confidential include: (1) DOE invites all interested parties to www.regulations.gov provides after you A description of the items; (2) whether submit in writing by April 12, 2019, have successfully uploaded your and why such items are customarily comments and information on matters comment. treated as confidential within the addressed in this notice and on other Submitting comments via email, hand industry; (3) whether the information is matters relevant to DOE’s consideration delivery, or postal mail. Comments and generally known by or available from of amended energy conservations documents submitted via email, hand other sources; (4) whether the standards for DHE. After the close of the delivery, or postal mail also will be information has previously been made comment period, DOE will review the posted to http://www.regulations.gov. If available to others without obligation public comments received and may you do not want your personal contact concerning its confidentiality; (5) an begin collecting data and conducting the information to be publicly viewable, do explanation of the competitive injury to analyses discussed in this RFI. not include it in your comment or any the submitting person which would Submitting comments via http:// accompanying documents. Instead, result from public disclosure; (6) when www.regulations.gov. The http:// provide your contact information on a such information might lose its www.regulations.gov web page requires cover letter. Include your first and last confidential character due to the you to provide your name and contact names, email address, telephone passage of time, and (7) why disclosure information. Your contact information number, and optional mailing address. of the information would be contrary to will be viewable to DOE Building The cover letter will not be publicly the public interest.

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It is DOE’s policy that all comments ACTION: Notice; extension of comment Corporation, 550 17th Street NW, may be included in the public docket, period. Washington, DC 20429. without change and as received, SUPPLEMENTARY INFORMATION: On SUMMARY: including any personal information On December 17, 2018, the December 17, 2018, the Board, FDIC, provided in the comments (except Board of Governors of the Federal and OCC published in the Federal information deemed to be exempt from Reserve System (Board), the Federal Register a proposal to amend the public disclosure). Deposit Insurance Corporation (FDIC), agencies’ capital rule to implement the DOE considers public participation to and the Office of the Comptroller of the Standardized Approach for Calculating be a very important part of the process Currency (OCC) (collectively, the the Exposure Amount of Derivatives for developing energy conservation agencies) published in the Federal Contracts.1 The notice of proposed standards. DOE actively encourages the Register a proposal to amend the rulemaking stated that the comment participation and interaction of the agencies’ capital rule to implement the period would close on February 15, public during the comment period in Standardized Approach for Calculating 2019. The agencies have received each stage of the process. Interactions the Exposure Amount of Derivatives requests to extend the comment period. with and between members of the Contracts. The agencies have An extension of the comment period public provide a balanced discussion of determined that an extension of the will provide additional opportunity for the issues and assist DOE in the process. comment period until March 18, 2019, the public to consider the proposal and Anyone who wishes to be added to the is appropriate. prepare comments, including to address DOE mailing list to receive future DATES: Comments must be received by the questions posed by the agencies. notices and information about this March 18, 2019. Therefore, the agencies are extending process or would like to request a public ADDRESSES: You may submit comments the end of the comment period for the meeting should contact Appliance and by any of the methods identified in the proposal from February 15, 2019, to Equipment Standards Program staff at proposal. March 18, 2019. (202) 287–1445 or via email at FOR FURTHER INFORMATION CONTACT: Dated: February 19, 2019. ApplianceStandardsQuestions@ OCC: Guowei Zhang, Risk Expert, ee.doe.gov. Joseph M. Otting, Capital Policy, (202) 649–7106; Kevin Comptroller of the Currency. Signed in Washington, DC, on February 13, Korzeniewski, Counsel, (202) 649–5490; By order of the Board of Governors of the 2019. or Ron Shimabukuro, Senior Counsel, Federal Reserve System, acting through the Steven Chalk, (202) 649–5490, or, for persons who are Secretary of the Board under delegated Acting Deputy Assistant Secretary for Energy deaf or hearing impaired, TTY, (202) authority, February 14, 2019. Efficiency, Energy Efficiency and Renewable 649–5597, Chief Counsel’s Office, Office Ann E. Misback, Energy. of the Comptroller of the Currency, 400 Secretary of the Board. [FR Doc. 2019–03270 Filed 2–25–19; 8:45 am] 7th Street SW, Washington, DC 20219. Dated at Washington, DC, on February 15, BILLING CODE 6450–01–P Board: Constance M. Horsley, Deputy Associate Director, (202) 452–5239; 2019. By order of the Board of Directors. David Lynch, Deputy Associate Federal Deposit Insurance Corporation. DEPARTMENT OF TREASURY Director, (202) 452–2081; Elizabeth MacDonald, Manager, (202) 475–6316; Valerie J. Best, Office of the Comptroller of the Michael Pykhtin, Manager, (202) 912– Assistant Executive Secretary. Currency 4312; Mark Handzlik, Senior [FR Doc. 2019–03249 Filed 2–25–19; 8:45 am] Supervisory Financial Analyst, (202) BILLING CODE P 12 CFR Parts 3 and 32 475–6636; Sara Saab, Supervisory [Docket ID OCC–2018–0030] Financial Analyst, (202) 872–4936; or Noah Cuttler, Senior Financial Analyst, DEPARTMENT OF HOMELAND RIN 1557–AE44 (202) 912–4678; Division of Supervision SECURITY and Regulation; or Benjamin W. FEDERAL RESERVE SYSTEM McDonough, Assistant General Counsel, Coast Guard (202) 452–2036; Gillian Burgess, Senior 12 CFR Part 217 Counsel, (202) 736–5564; Mark Buresh, 33 CFR Part 100 [Docket R–1629] Counsel, (202) 452–5270; Andrew [Docket Number USCG–2019–0051] Hartlage, Counsel, (202) 452–6483; RIN 7100–AF22 Legal Division, Board of Governors of RIN 1625–AA08 FEDERAL DEPOSIT INSURANCE the Federal Reserve System, 20th and C Special Local Regulation; Choptank CORPORATION Streets NW, Washington, DC 20551. For the hearing impaired only, River, Cambridge, MD 12 CFR Part 324 Telecommunication Device for the Deaf, AGENCY: Coast Guard, DHS. (202) 263–4869. ACTION: Notice of proposed rulemaking. RIN 3064–AE80 FDIC: Bobby R. Bean, Associate Notice, Extension of Comment Period; Director, [email protected]; Irina Leonova, SUMMARY: The Coast Guard proposes to Standardized Approach for Calculating Senior Policy Analyst, ileonova@ establish special local regulations for the Exposure Amount of Derivatives fdic.gov; Peter Yen, Senior Policy certain waters of the Choptank River. Contracts Analyst, [email protected], Capital Markets This action is necessary to provide for Branch, Division of Risk Management the safety of life on these navigable AGENCY: The Board of Governors of the Supervision, (202) 898–6888; or Michael waters located at Cambridge, MD, Federal Reserve System; the Federal Phillips, Counsel, [email protected]; during a swim event on the morning of Deposit Insurance Corporation, and the Catherine Wood, Counsel, cawood@ May 11, 2019. This proposed Office of the Comptroller of the fdic.gov; Supervision Branch, Legal Currency, Treasury. Division, Federal Deposit Insurance 1 83 FR 64660 (December 17, 2018).

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rulemaking would prohibit persons and to participate in this event or for vessels assigned as official patrols would be vessels from entering the regulated area that operate within specified waters of considered a spectator. Official Patrols unless authorized by the Captain of the the Choptank River. are any vessel assigned or approved by Port Maryland-National Capital Region The purpose of this rulemaking is to the Commander, Coast Guard Sector or the Coast Guard Patrol Commander. protect event participants, spectators Maryland-National Capital Region with We invite your comments on this and transiting vessels on certain waters a commissioned, warrant, or petty proposed rulemaking. of the Choptank River before, during, officer on board and displaying a Coast DATES: Comments and related material and after the scheduled event. The Coast Guard ensign. must be received by the Coast Guard on Guard proposes this rulemaking under authority in 33 U.S.C. 1231, which If permission is granted by the COTP or before March 28, 2019. or PATCOM, a person or vessel would ADDRESSES: You may submit comments authorizes the Coast Guard to establish and define special local regulations. be allowed to enter the regulated area or identified by docket number USCG– pass directly through the regulated area 2019–0051 using the Federal III. Discussion of Proposed Rule as instructed. Vessels would be required eRulemaking Portal at http:// The COTP Maryland-National Capital to operate at a safe speed that minimizes www.regulations.gov. See the ‘‘Public Region proposes to establish special wake while within the regulated area. Participation and Request for local regulations from 8 a.m. through 11 Official patrol vessels will direct Comments’’ portion of the a.m. on May 11, 2019. There is no spectator vessels while within the SUPPLEMENTARY INFORMATION section for alternate date planned for this event. regulated area. Vessels would be further instructions on submitting The regulated area would cover all prohibited from loitering within the comments. navigable waters of the Choptank River, navigable channel. Only participant FOR FURTHER INFORMATION CONTACT: If from shoreline to shoreline, within an vessels and official patrol vessels would you have questions about this proposed area bounded on the east by a line be allowed to enter the race area. rulemaking, call or email Mr. Ron drawn from latitude 38°35′14.2″ N, Houck, U.S. Coast Guard Sector ° ′ ″ The regulatory text we are proposing longitude 076 02 33.0 W, thence south appears at the end of this document. Maryland-National Capital Region; to latitude 38°34′08.3″ N, longitude telephone 410–576–2674, email 076°03′36.2″ W, and bounded on the IV. Regulatory Analyses [email protected]. west by a line drawn from latitude SUPPLEMENTARY INFORMATION: 38°35′32.7″ N, longitude 076°02′58.3″ We developed this proposed rule after W, thence south to latitude 38°34′24.7″ considering numerous statutes and I. Table of Abbreviations N, longitude 076°04′01.3″ W, located at Executive orders related to rulemaking. CFR Code of Federal Regulations Cambridge, MD. The regulated area is Below we summarize our analyses COTP Captain of the Port approximately 2,800 yards in length and based on a number of these statutes and DHS Department of Homeland Security 900 yards in width. Executive orders and we discuss First FR Federal Register The proposed duration special local Amendment rights of protestors. NPRM Notice of proposed rulemaking regulations and size of the regulated PATCOM Coast Guard Patrol Commander A. Regulatory Planning and Review § Section area are intended to ensure the safety of U.S.C. United States Code life on these navigable waters before, Executive Orders 12866 and 13563 during, and after the open water swim, direct agencies to assess the costs and II. Background, Purpose, and Legal scheduled from 9 a.m. to 10:45 a.m. on Basis benefits of available regulatory May 11, 2019. The COTP and the Coast alternatives and, if regulation is The TCR Event Management of St. Guard Patrol Commander (PATCOM) necessary, to select regulatory Michaels, MD, notified the Coast Guard would have authority to forbid and approaches that maximize net benefits. that it will be conducting the Maryland control the movement of all vessels and Executive Order 13771 directs agencies Freedom Swim on the morning of May persons, including event participants, in to control regulatory costs through a 11, 2019. The open water swim consists the regulated area. When hailed or budgeting process. This NPRM has not of approximately 250 participants signaled by an official patrol, a vessel or been designated a ‘‘significant competing on a designated 1.75-mile person in the regulated area would be regulatory action,’’ under Executive linear course. The course starts at the required to immediately comply with Order 12866. Accordingly, the NPRM beach of Bill Burton Fishing Pier State the directions given by the COTP or has not been reviewed by the Office of Park at Trappe, MD, proceeds across the PATCOM. If a person or vessel fails to Management and Budget (OMB), and Choptank River along and between the follow such directions, the Coast Guard pursuant to OMB guidance it is exempt fishing piers and the Senator Frederick may expel them from the area, issue from the requirements of Executive C. Malkus, Jr. Memorial (US–50) Bridge, them a citation for failure to comply, or Order 13771. and finishes at the beach of the both. Dorchester County Visitors Center at Except for Maryland Freedom Swim This regulatory action determination Cambridge, MD. Hazards from the swim participants and vessels already at is based on size, time of day and competition include participants berth, a vessel or person would be duration of the regulated area, which swimming within and adjacent to the required to get permission from the would impact a small designated area of designated navigation channel and COTP or PATCOM before entering the the Choptank River for 3 hours. The interfering with vessels intending to regulated area. Vessel operators can Coast Guard would issue a Broadcast operate within that channel, as well as request permission to enter and transit Notice to Mariners via VHF–FM marine swimming within approaches to local through the regulated area by contacting channel 16 about the status of the public and private marinas and public the PATCOM on VHF–FM channel 16. regulated area. Moreover, the rule boat facilities. The Captain of the Port Vessel traffic would be able to safely would allow vessels to seek permission (COTP) Maryland-National Capital transit the regulated area once the to enter the regulated area, and vessel Region has determined that potential PATCOM deems it safe to do so. A traffic would be able to safely transit the hazards associated with the swim would person or vessel not registered with the regulated area once the PATCOM deems be a safety concern for anyone intending event sponsor as a participant or it safe to do so.

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B. Impact on Small Entities federalism principles and preemption G. Protest Activities The Regulatory Flexibility Act of requirements described in Executive The Coast Guard respects the First 1980, 5 U.S.C. 601–612, as amended, Order 13132. Amendment rights of protesters. requires Federal agencies to consider Also, this proposed rule does not have Protesters are asked to contact the the potential impact of regulations on tribal implications under Executive person listed in the FOR FURTHER small entities during rulemaking. The Order 13175, Consultation and INFORMATION CONTACT section to term ‘‘small entities’’ comprises small Coordination with Indian Tribal coordinate protest activities so that your businesses, not-for-profit organizations Governments, because it would not have message can be received without that are independently owned and a substantial direct effect on one or jeopardizing the safety or security of operated and are not dominant in their more Indian tribes, on the relationship people, places, or vessels. fields, and governmental jurisdictions between the Federal Government and V. Public Participation and Request for with populations of less than 50,000. Indian tribes, or on the distribution of Comments The Coast Guard certifies under 5 U.S.C. power and responsibilities between the 605(b) that this proposed rule would not Federal Government and Indian tribes. We view public participation as have a significant economic impact on If you believe this proposed rule has essential to effective rulemaking, and a substantial number of small entities. implications for federalism or Indian will consider all comments and material While some owners or operators of tribes, please contact the person listed received during the comment period. Your comment can help shape the vessels intending to transit the safety in the FOR FURTHER INFORMATION outcome of this rulemaking. If you zone may be small entities, for the CONTACT section. reasons stated in section IV.A above, submit a comment, please include the this proposed rule would not have a E. Unfunded Mandates Reform Act docket number for this rulemaking, significant economic impact on any indicate the specific section of this vessel owner or operator. The Unfunded Mandates Reform Act document to which each comment If you think that your business, of 1995 (2 U.S.C. 1531–1538) requires applies, and provide a reason for each organization, or governmental Federal agencies to assess the effects of suggestion or recommendation. jurisdiction qualifies as a small entity their discretionary regulatory actions. In We encourage you to submit and that this rule would have a particular, the Act addresses actions comments through the Federal significant economic impact on it, that may result in the expenditure by a eRulemaking Portal at http:// please submit a comment (see State, local, or tribal government, in the www.regulations.gov. If your material ADDRESSES) explaining why you think it aggregate, or by the private sector of cannot be submitted using http:// qualifies and how and to what degree $100,000,000 (adjusted for inflation) or www.regulations.gov, contact the person this rule would economically affect it. more in any one year. Though this in the FOR FURTHER INFORMATION Under section 213(a) of the Small proposed rule would not result in such CONTACT section of this document for Business Regulatory Enforcement an expenditure, we do discuss the alternate instructions. Fairness Act of 1996 (Pub. L. 104–121), effects of this rule elsewhere in this We accept anonymous comments. All we want to assist small entities in preamble. comments received will be posted understanding this proposed rule. If the without change to http:// F. Environment rule would affect your small business, www.regulations.gov and will include organization, or governmental We have analyzed this proposed rule any personal information you have jurisdiction and you have questions under Department of Homeland provided. For more about privacy and concerning its provisions or options for Security Directive 023–01 and the docket, visit http:// compliance, please contact the person Commandant Instruction M16475.1D, www.regulations.gov/privacyNotice. listed in the FOR FURTHER INFORMATION which guide the Coast Guard in Documents mentioned in this NPRM CONTACT section. The Coast Guard will complying with the National as being available in the docket, and all public comments, will be in our online not retaliate against small entities that Environmental Policy Act of 1969 (42 docket at http://www.regulations.gov question or complain about this U.S.C. 4321–4370f), and have made a and can be viewed by following that proposed rule or any policy or action of preliminary determination that this website’s instructions. Additionally, if the Coast Guard. action is one of a category of actions that you go to the online docket and sign up do not individually or cumulatively C. Collection of Information for email alerts, you will be notified This proposed rule would not call for have a significant effect on the human when comments are posted or a final a new collection of information under environment. This proposed rule rule is published. the Paperwork Reduction Act of 1995 involves implementation of regulations List of Subjects in 33 CFR Part 100 (44 U.S.C. 3501–3520). within 33 CFR part 100 applicable to organized marine events on the Marine safety, Navigation (water), D. Federalism and Indian Tribal navigable waters of the United States Reporting and recordkeeping Governments that could negatively impact the safety requirements, Waterways. A rule has implications for federalism of waterway users and shore side For the reasons discussed in the under Executive Order 13132, activities in the event area lasting for 3 preamble, the Coast Guard proposes to Federalism, if it has a substantial direct hours. Normally such actions are amend 33 CFR part 100 as follows: effect on the States, on the relationship categorically excluded from further between the national government and review under paragraph L[61] of PART 100—SAFETY OF LIFE ON the States, or on the distribution of Appendix A, Table 1 of DHS Instruction NAVIGABLE WATERS power and responsibilities among the Manual 023–01–001–01, Rev. 01. We various levels of government. We have seek any comments or information that ■ 1. The authority citation for part 100 analyzed this proposed rule under that may lead to the discovery of a continues to read as follows: Order and have determined that it is significant environmental impact from Authority: 33 U.S.C. 1233; 33 CFR 1.05– consistent with the fundamental this proposed rule. 1.

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■ 2. Add § 100.501T05–0051 to read as event, or a participant’s operations at DEPARTMENT OF THE INTERIOR follows: any time the COTP Maryland-National Capital Region or PATCOM believes it Fish and Wildlife Service § 100.501T05–0051 Special Local necessary to do so for the protection of Regulation; Choptank River, Cambridge, 50 CFR Part 17 MD. life or property. (a) Definitions. As used in this (2) Except for participants and vessels [Docket No. FWS–R1–ES–2017–0035; section: already at berth, a person or vessel FXES11130900000–189–FF09E30000] Captain of the Port (COTP) Maryland- within the regulated area at the start of RIN 1018–BA43 National Capital Region means the enforcement of this section must Commander, U.S. Coast Guard Sector immediately depart the regulated area. Endangered and Threatened Wildlife and Plants; Removing the Borax Lake Maryland-National Capital Region or (3) A spectator must contact the any Coast Guard commissioned, warrant Chub From the List of Endangered and PATCOM to request permission to or petty officer who has been authorized Threatened Wildlife either enter or pass through the by the COTP to act on his behalf. AGENCY: Coast Guard Patrol Commander regulated area. The PATCOM, and Fish and Wildlife Service, (PATCOM) means a commissioned, official patrol vessels enforcing this Interior. warrant, or petty officer of the U.S. regulated area, can be contacted on ACTION: Proposed rule. Coast Guard who has been designated marine band radio VHF–FM channel 16 SUMMARY: We, the U.S. Fish and by the Commander, Coast Guard Sector (156.8 MHz) and channel 22A (157.1 MHz). If permission is granted, the Wildlife Service (Service or USFWS), Maryland-National Capital Region. propose to remove the Borax Lake chub Official Patrol means any vessel spectator must pass directly through the (currently listed as Gila boraxobius), a assigned or approved by Commander, regulated area as instructed by fish native to Oregon, from the Federal Coast Guard Sector Maryland-National PATCOM. A vessel within the regulated List of Endangered and Threatened Capital Region with a commissioned, area must operate at safe speed that Wildlife on the basis of recovery. This warrant, or petty officer on board and minimizes wake. A spectator vessel proposal is based on a review of the best displaying a Coast Guard ensign. must not loiter within the navigable available scientific and commercial Participants means all persons and channel while within the regulated area. information, which indicates that the vessels registered with the event (4) A person or vessel that desires to threats to the Borax Lake chub have sponsor as participating in the Flying transit, moor, or anchor within the been eliminated or reduced to the point Point Park Outboard Regatta or where the species no longer meets the otherwise designated by the event regulated area must obtain authorization definition of an endangered or sponsor as having a function tied to the from the COTP Maryland-National threatened species under the event. Capital Region or PATCOM. A person or Spectators means all persons and vessel seeking such permission can Endangered Species Act of 1973, as vessels not registered with the event contact the COTP Maryland-National amended (Act). We are seeking sponsor as participants or assigned as Capital Region at telephone number information and comments from the official patrols. 410–576–2693 or on Marine Band public regarding this proposed rule. (b) Location. All coordinates reference Radio, VHF–FM channel 16 (156.8 DATES: We will accept comments Datum NAD 1983. MHz) or the PATCOM on Marine Band received or postmarked on or before (1) Regulated area. All navigable Radio, VHF–FM channel 16 (156.8 April 29, 2019. Please note that if you waters of the Choptank River, from MHz). are using the Federal eRulemaking shoreline to shoreline, within an area Portal (see ADDRESSES, below), the (5) The Coast Guard will publish a deadline for submitting an electronic bounded on the east by a line drawn notice in the Fifth Coast Guard District from latitude 38°35′14.2″ N, longitude comment is 11:59 p.m. Eastern time on Local Notice to Mariners and issue a 076°02′33.0″ W, thence south to latitude this date. We must receive requests for marine information broadcast on VHF– 38°34′08.3″ N, longitude 076°03′36.2″ public hearings, in writing, at the W, and bounded on the west by a line FM marine band radio announcing address shown in FOR FURTHER drawn from latitude 38°35′32.7″ N, specific event date and times. INFORMATION CONTACT by April 12, 2019. longitude 076°02′58.3″ W, thence south (d) Enforcement officials. The Coast ADDRESSES: You may submit comments to latitude 38°34′24.7″ N, longitude Guard may be assisted with marine by one of the following methods: 076°04′01.3″ W, located at Cambridge, event patrol and enforcement of the (1) Electronically: Go to the Federal MD. regulated area by other Federal, State, eRulemaking Portal: http:// (2) Reserved. and local agencies. www.regulations.gov. In the Search box, (c) Special local regulations: (1) The enter FWS–R1–ES–2017–0035, which is (e) Enforcement period. This section COTP Maryland-National Capital the docket number for this rulemaking. will be enforced from 8 a.m. to 11 a.m. Region or PATCOM may forbid and Then, click on the Search button. On the on May 11, 2019. control the movement of all vessels and resulting page, in the Search panel on persons, including event participants, in Dated: February 19, 2019. the left side of the screen, under the the regulated area. When hailed or Joseph B. Loring, Document Type heading, click on the signaled by an official patrol, a vessel or Captain, U.S. Coast Guard, Captain of the Proposed Rule box to locate this person in the regulated area shall Port Maryland-National Capital Region. document. You may submit a comment immediately comply with the directions [FR Doc. 2019–03254 Filed 2–25–19; 8:45 am] by clicking on ‘‘Comment Now!’’ Please given by the patrol. Failure to do so may ensure that you have found the correct BILLING CODE 9110–04–P result in the Coast Guard expelling the rulemaking before submitting your person or vessel from the area, issuing comment. a citation for failure to comply, or both. (2) By hard copy: Submit by U.S. mail The COTP Maryland-National Capital or hand-delivery to: Public Comments Region or PATCOM may terminate the Processing, Attn: FWS–R1–ES–2017–

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0035, U.S. Fish and Wildlife Service, the inadequacy of existing regulatory Borax Lake chub due to changes in the MS: BPHC, 5275 Leesburg Pike, Falls mechanisms; or (E) other natural or climate or other reasons (including any Church, VA 22041–3803. manmade factors affecting its continued modeling data and projections for the We request that you send comments existence. We have determined that the Alvord Basin); only by the methods described above. Borax Lake chub is no longer at risk of (5) Information regarding potential for We will post all comments on http:// extinction, and the following criteria for geothermal energy development in the www.regulations.gov. This generally delisting described in the species vicinity of Borax Lake, and any means that we will post any personal recovery plan have been met or information useful for determining the information you provide us (see Public exceeded: extent of potential effects to Borax Lake; Comments, below, for more • The presence of a naturally and information). reproducing population of Borax Lake (6) Any information relevant to Document availability: This proposed chub in Borax Lake that is free of exotic whether the species falls within the rule is available on http:// species; definition of either an endangered www.regulations.gov. In addition, the • Permanent protection of the 160- species under section 3(6) of the Act (16 supporting file for this proposed rule acre (ac) (65-hectare (ha)) parcel of land U.S.C. 1531 et seq.) or a threatened will be available for public inspection, surrounding and including Borax Lake; species under section 3(20) of the Act, by appointment, during normal business • Removal of threats to subsurface including information on the five listing hours, at our Oregon Fish and Wildlife waters from geothermal energy factors under section 4(a)(1) of the Act Office, 2600 SE 98th Avenue, Suite 100, exploration or development; and any other factors meeting the Portland, OR 97266; telephone 503– • Reestablishment of ponds and criteria to support the recovery and 231–6179. natural marshes adjacent to Borax Lake removal of the species from the List of Endangered and Threatened Wildlife FOR FURTHER INFORMATION CONTACT: Paul in order to create more chub habitat; • A viable, self-sustaining population (List; 50 CFR 17.11(h)). Henson, State Supervisor, telephone: Please include sufficient information 503–231–6179. Direct all questions or of Borax Lake chub; • with your submission (such as scientific requests for additional information to: Permanent protection of the 160-ac (65-ha) parcel of land to the north of journal articles or other publications) to BORAX LAKE CHUB QUESTIONS, U.S. allow us to verify any scientific or Fish and Wildlife Service, Oregon Fish Borax Lake; • commercial information you include. and Wildlife Office, 2600 SE 98th Withdrawal of Borax Lake waters from appropriation (i.e., diversion and Please note that submissions merely Avenue, Suite 100, Portland, OR 97266. stating support for or opposition to the Persons who use a telecommunications use under water right); • Establishment of a fence around the action under consideration without device for the deaf (TDD) may call the providing supporting information, Federal Relay Service at 800–877–8339. 640-ac (259-ha) critical habitat area to prevent vehicle entry; although noted, will not be considered SUPPLEMENTARY INFORMATION: • Establishment of monitoring in making a determination, as section Executive Summary programs to survey habitat and fish 4(b)(1)(A) of the Act directs that determinations as to whether any Why we need to publish a rule. Under population status; and • Lack of any new threats to the species is an endangered or threatened the Act, a species may warrant removal species must be made ‘‘solely on the from the List of Endangered and species or ecosystem for 5 consecutive years. basis of the best scientific and Threatened Wildlife (i.e., ‘‘delisting’’) if commercial data available.’’ it no longer meets the definition of Information Requested We will take into consideration all endangered or threatened. A species is comments and any additional Public Comments an ‘‘endangered species’’ for purposes of information we receive. Such the Act if it is in danger of extinction We intend that any final rule resulting information may lead to a final rule that throughout all or a significant portion of from this proposal will be based on the differs from this proposal. All its range and is a ‘‘threatened species’’ best available scientific and commercial comments, including commenters’ if it is likely to become an endangered data and will be as accurate and names and addresses, if provided to us, species within the foreseeable future effective as possible. Therefore, we will become part of the administrative throughout all or a significant portion of invite Tribal, State, and governmental record. its range. The Borax Lake chub is agencies; the scientific community; You may submit your comments and currently listed as endangered, and we industry; and other interested parties to materials concerning this proposed rule are proposing to delist the species submit comments or recommendations by one of the methods listed in because we have determined it no concerning any aspect of this proposed ADDRESSES. We will not consider longer meets the definition of rule. Comments should be as specific as comments sent by email, by fax, or to an endangered and is not likely to become possible. We are specifically requesting address not listed in ADDRESSES. If you endangered in the foreseeable future. comments on: submit your comments electronically, We can only delist a species by issuing (1) Biological information concerning your comments must be submitted a rule to do so. the Borax Lake chub and information on through the Federal eRulemaking Portal The basis for our action. A species the Borax Lake ecosystem; (http://www.regulations.gov) before may be determined to be an endangered (2) Relevant data concerning presence 11:59 p.m. Eastern time on the date species or threatened species because of or absence of current or future threats to specified in DATES. We will not consider any one or a combination of the five the Borax Lake chub and its habitat; hand-delivered comments that we do factors described in section 4(a)(1) of the (3) Information regarding management not receive by the date specified in Act: (A) The present or threatened plans or other mechanisms that provide DATES, or mailed comments that are not destruction, modification, or protection to the Borax Lake chub and postmarked by that date. curtailment of its habitat or range; (B) its habitat; We will post your entire comment— overutilization for commercial, (4) Information on the potential for including your personal identifying recreational, scientific, or educational changes in precipitation levels and air information—on http:// purposes; (C) disease or predation; (D) and water temperatures to affect the www.regulations.gov. If you provide

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personal identifying information in your boraxobius) as an endangered species Management (BLM), Oregon Department comment, you may request at the top of and to designate critical habitat (45 FR of Fish and Wildlife (ODFW), and The your document that we withhold this 68886). The distribution of the Borax Nature Conservancy (TNC) have information from public review. Lake chub is limited to Borax Lake, its continued to implement recovery However, we cannot guarantee that we outflow, and Lower Borax Lake in actions; the CMP has been finalized; a will be able to do so. Harney County, Oregon. The proposed fence to eliminate vehicle access to Comments and materials we receive, listing action was taken because critical habitat has been completed as well as supporting documentation we proposed geothermal development in around Borax Lake; and monitoring of used in preparing this proposed rule, and around Borax Lake, and human Borax Lake chub and the Borax Lake will be available for public inspection modification of the lake, threatened the ecosystem has been conducted. on http://www.regulations.gov, or by integrity of the species’ habitat and, Although the recovery plan did not call appointment, during normal business hence, its survival. for acquisition of groundwater and hours at the U.S. Fish and Wildlife On October 5, 1982, we published a surface rights to geothermal Service, Oregon Fish and Wildlife Office final rule in the Federal Register (47 FR development on private lands outside (see Document availability under 43957) listing the Borax Lake chub (as the two 160-ac (65-ha) parcels ADDRESSES, above). Gila boraxobius) as endangered and eventually acquired by TNC and designating areas totaling 640 acres (ac) designated critical habitat, the Service’s Public Hearing (259 hectares (ha)) in and around Borax 2012 5-year review and CMP make that Section 4(b)(5)(E) of the Act provides Lake as critical habitat for the Borax conservation recommendation. for one or more public hearings on this Lake chub. A recovery plan for the Although we will continue to work with proposal, if requested. We must receive species was completed on February 4, our partners to seek opportunities to requests for public hearings, in writing, 1987 (USFWS 1987). reduce potential risk from geothermal at the address shown in FOR FURTHER A 5-year review of the Borax Lake development on private lands in INFORMATION CONTACT within 45 days chub’s status was completed on August proximity to Borax Lake, we no longer after the date of this Federal Register 23, 2012 (USFWS 2012); this review view geothermal development as an publication (see DATES, above). We will concluded that the Borax Lake chub’s operative threat such that the Borax schedule at least one public hearing on status had substantially improved since Lake chub meets the definition of an this proposal, if any are requested, and listing, and that the Borax Lake chub no endangered or a threatened species announce the date, time, and place of longer met the definition of an under the Act. The Pueblo Valley the hearing(s), as well as how to obtain endangered species, but may meet the Geothermal LLC (Limited Liability reasonable accommodations, in the definition of a threatened species Company), the last entity showing Federal Register at least 15 days before throughout all of its range, under the interest in geothermal development in any first hearing. Act. Therefore, the review the Alvord Basin, did not file a formal recommended the Borax Lake chub be permit application with the BLM or the Peer Review reclassified from endangered to State of Oregon’s Department of Geology In accordance with our policy, threatened (i.e., ‘‘downlisted’’). and Mineral Industries (DOGAMI), and ‘‘Notice of Interagency Cooperative However, this proposed rule, which is the LLC was dissolved in 2013. We are Policy for Peer Review in Endangered based on information contained in the unaware of any current proposals to Species Act Activities,’’ which was 5-year review as well as additional develop geothermal energy production published on July 1, 1994 (59 FR information that has become available in the Alvord Basin. since completion of the 5-year review, 34270), we will seek the expert opinion Species Information of at least three appropriate proposes to remove the Borax Lake chub independent specialists regarding from the List (i.e., to ‘‘delist’’ the At the time of listing, the genus Gila scientific data and interpretations species). was considered to include three Although we acknowledged in the 5- contained in this proposed rule. We will subgenera: Gila, Siphateles (including year review that recovery criteria had send copies of this proposed rule to the the Borax Lake chub), and largely been met, we recommended peer reviewers immediately following Snyderichthys (Uyeno 1961, pp. 84–85; downlisting instead of delisting due to publication in the Federal Register. Bailey and Uyeno 1964, pp. 238–239). the potential threat of geothermal Since our final listing determination (47 This assessment will be completed development that, at the time, was FR 43957; October 5, 1982), analysis of during the public comment period. The represented by a 2012 proposed lepidological (scale morphology and purpose of such review is to ensure that geothermal development on private arrangement) and osteological (structure our decisions are based on scientifically lands within 1 to 3 miles (mi) (1.6 to 4.8 and function of bones) characters sound data, assumptions, and analysis. kilometers (km)) of Borax Lake. In (Coburn and Cavender 1992, pp. 344– Accordingly, the final decision may addition to the recommendation to 347) and mitochondrial ribosomal RNA differ from this proposal. reclassify, the 5-year review further sequences (Simons and Mayden 1997, p. Background recommended three remaining actions: 194; 1998, p. 315; Simons et al. 2003, (1) Completion of the Borax Lake Chub pp. 71–76) have indicated that the genus Previous Federal Actions Cooperative Management Plan (CMP); Gila in the broad sense was not On May 28, 1980, we published a rule (2) acquisition of groundwater and descended from a common ancestor not in the Federal Register to emergency- surface rights to geothermal shared with other groups. Therefore, the list the Borax Lake chub (as Gila sp.) as development on private lands to three subgenera were elevated to genera. endangered and to designate critical complement the Federal land mineral The American Fisheries Society (Page et habitat for the species (45 FR 35821). withdrawal within the Alvord Known al. 2013, p. 78) has also followed this The emergency rule provided protection Geothermal Resource Area; and (3) approach and classified the Borax Lake to this species for 240 days, until monitoring of the Borax Lake chub and chub within the genus Siphateles. January 23, 1981. the Borax Lake ecosystem. Consequently, the current scientific On October 16, 1980, we proposed to Since completion of the 2012 5-year name of the Borax Lake chub is list the Borax Lake chub (as Gila review, the Service, Bureau of Land Siphateles boraxobius. This taxonomic

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revision changed the name of the listed clear, but Scheerer et al. (2012, p. 16) whether that information differs from entity from Gila boraxobius to surmised that because Borax Lake chub the recovery plan. Siphateles boraxobius, but did not alter experience water temperatures that are Recovery plans may be revised to the description, distribution, range, or at or near their thermal critical address continuing or new threats to the listing status of the species from what it maximum (Williams and Bond 1983, p. species as new substantive information was at the time of listing. Based on this 412), survival and recruitment are likely becomes available. The recovery plan revision, we consider Siphateles higher during years when water identifies site-specific management boraxobius to be the most appropriate temperatures are cooler in the lake. actions that will achieve recovery of the scientific name for this taxon. Because Water temperatures in Borax Lake are species, measurable criteria that set a we are proposing to remove the species influenced both by air temperatures and trigger for review of the species’ status, from the List, we are not proposing to by the water temperature of the lake’s and methods for monitoring recovery amend the species’ scientific name on primary source of inflow, a deep progress. Recovery plans are intended to the List, but future documents, such as geothermal aquifer. establish goals for long-term the post-delisting monitoring plan for conservation of listed species and define the species, should reflect this usage. Recovery criteria that are designed to indicate The Borax Lake chub is a small Recovery Planning when the threats facing a species have minnow (Family: Cyprinidae) endemic been removed or reduced to such an to Borax Lake and its outflows. Borax Section 4(f) of the Act directs us to extent that the species may no longer Lake is a 10.2-ac (4.1-ha) geothermally develop and implement recovery plans need the protections of the Act. heated, alkaline spring-fed lake in for the conservation and survival of There can be many paths to southeastern Oregon. The lake is endangered and threatened species accomplishing recovery of a species, perched 30 feet (ft) (10 meters (m)) unless we determine that such a plan and because a status determination must above the desert floor on large sodium- will not promote the conservation of the be based on a current analysis of the five borate deposits (Williams and Bond species. Under section 4(f)(1)(B)(ii), threat factors under section 4(a)(1), it 1980, p. 297). Water depth averages recovery plans must, to the maximum may be possible to achieve recovery approximately 3.3 ft (1.0 m), with a extent practicable, include objective, without fully meeting the recovery maximum measured depth of 88.6 ft (27 measurable criteria which, when met, criteria that were identified at the time m) at the thermal vent (Scheerer and would result in a determination, in the recovery plan was completed. For Jacobs 2005, p. 6). The lake bottom accordance with the provisions of example, a five-factor analysis may includes patches of bedrock and fine section 4 of the Act, that the species be determine that current information on gravel, with a sparse growth of aquatic removed from the List. However, threats and species status indicates the plants, and is covered with thick, fluffy revisions to the List (i.e., adding, threats have been minimized silt. Average lake temperatures range removing, or reclassifying a species) sufficiently to delist or downlist while ° from a high of 39.2 degrees Celsius ( C) must reflect determinations made in the recovery criteria have been partially ° (102.6 degrees Fahrenheit ( F)) to a low accordance with sections 4(a)(1) and or fully met or exceeded in various ° ° of 22 C (71.6 F) near the shoreline 4(b) of the Act. Section 4(a)(1) requires combinations. In other cases, recovery (Scheerer et al. 2013, pp. 3–6). Borax that the Secretary determine whether a opportunities may be discovered that Lake chub prefer the shallow habitats species is endangered or threatened (or were not known when the recovery plan along the margins of the lake (Perkins et not) because of one or more of five was finalized. These opportunities may al. 1996, p. 8). threat factors. Section 4(b) of the Act be used instead of methods identified in The Borax Lake chub is an requires that the determination be made the recovery plan. Likewise, information opportunistic omnivore. The diets of ‘‘solely on the basis of the best scientific on the species may be learned that was juveniles and adults are very similar and commercial data available.’’ not known at the time the recovery plan and include aquatic and terrestrial Therefore, recovery criteria should help was finalized. The new information may insects, algae, mollusks and mollusk indicate when we would anticipate that change the extent that earlier criteria eggs, aquatic worms, fish scales, spiders, an analysis of the five threat factors need to be met for recognizing recovery and seeds (Williams and Williams 1980, under section 4(a)(1) would result in a of the species. Recovery of a species is p. 113). Males, and some females, reach determination that the species is no a dynamic process requiring adaptive reproductive maturity within one year. longer an endangered species or management that may, or may not, fully Spawning occurs primarily in the spring threatened species (see Summary of follow the guidance provided in a but can occur year-around (Williams Factors Affecting the Species, below). recovery plan. and Bond 1983, pp. 412–413). The The Borax Lake Chub Recovery Plan reproductive behavior and length of While recovery plans provide (USFWS 1987, pp. 27–30) described an incubation is unknown. important guidance to the Service, ‘‘interim objective’’ for potential Population abundance estimates for States, and other partners on methods of reclassification to threatened status, as the Borax Lake chub were conducted minimizing threats to listed species and well as a ‘‘primary objective’’ for annually from 1986 to 1997, from 2005 measurable objectives against which to recovery that could result in removal of to 2012, and from 2015 to 2017. Over measure progress towards recovery, they the species from the List (i.e., delisting). this period, the population abundance are not regulatory documents and It established the following four has shown a high degree of variability, cannot substitute for the determinations conditions as criteria for reclassification ranging from a low of 1,242 in 2015, to and promulgation of regulations from endangered to threatened status a record high of 76,931 in 2017 required under section 4(a)(1) of the (i.e., downlisting): (Scheerer et al. 2015, p. 3; M. Meeuwig Act. A decision to revise the status of a (1) The presence of a naturally in litt. 2017). A pattern of population species or remove it from the List is reproducing population of the Borax reduction followed by a 1- to 5-year ultimately based on an analysis of the Lake chub in Borax Lake that is free of period of rebuilding has been observed best scientific and commercial data exotic species; multiple times during the period of available to determine whether a species (2) Permanent protection of the 160- record. The mechanisms contributing to is no longer an endangered species or a ac (65-ha) parcel of land surrounding variability in abundance are not entirely threatened species, regardless of and including Borax Lake (T37S, R33E,

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sec. 14) by TNC or other appropriate or aquarium-raised fish. The Borax Lake plan for the Andrews Resource Area public resource agency; chub population has never been added 80 ac (32 ha), for a total 600-ac (3) Removal of threats to subsurface supplemented with hatchery- or (243-ha) Borax Lake ACEC (BLM 2005a, waters from geothermal energy aquarium-raised fish and continues to p. 70). Following this designation, the exploration or development; and reproduce naturally on an annual basis. area was fenced to exclude livestock (4) Reestablishment of ponds and In the 3 decades Borax Lake chub have grazing. The lake is now completely natural marshes adjacent to Borax Lake been monitored, there has been only one enclosed by fencing, including most of in order to create more chub habitat, documented occurrence of an exotic fish the 640 ac (259 ha) of designated critical and reestablishment of Lower Borax species. In 2013, an ODFW biologist habitat, except for a small portion that Lake by waters from Borax Lake in order observed a nonnative fish that was serves as a parking area for pedestrian to create more habitat. believed to be a bass given observed access to the lake. The recovery plan stated that morphology (Scheerer et al. 2013, pp. 2– Downlisting Criterion 3: Removal of conditions to meet the primary objective 3, 9–10). Subsequent efforts to capture threats to subsurface waters from of recovery (i.e., delisting) include the or observe this fish or other nonnative geothermal energy exploration or above four downlisting conditions as fishes were unsuccessful, and none has development. This criterion has been well as the following six additional been seen in subsequent monitoring. met. While this criterion does not conditions: The survival in Borax Lake of this identify a geographic area for which (1) A viable, self-sustaining nonnative fish, or of any other threats of geothermal energy exploration population of Borax Lake chub, which commonly introduced nonnative fishes, or development should be removed, the is defined as a naturally sustaining is unlikely given the geothermally recovery plan’s step-down outline and population that is free of exotic species heated high water temperatures. narrative describing recovery actions and fluctuates in size within the We consider this criterion met based clearly identify this criterion as seasonal ranges observed in 1986–1987; on the lack of need for conservation pertaining to Borax Lake and two 160- (2) Permanent protection of the 160- actions supporting the species’ ac (65-ha) parcels of private land ac (65-ha) parcel of land to the north of reproductive success and the fact that surrounding Borax Lake (USFWS 1987, Borax Lake (T37S, R33E, sec. 11) by only a single occurrence of a nonnative pp. 30–45). These lands were eventually TNC or another appropriate public species has been documented. As noted purchased by TNC and designated resource agency; above, we determined the likelihood of critical habitat for Borax Lake chub, (3) Withdrawal of Borax Lake waters survival of this nonnative fish was low, thereby removing the threat of from appropriations (i.e., diversion and and no observations or detections of this geothermal development within close use under water right); or other nonnative fishes have been proximity to Borax Lake. Although the (4) Establishment of a fence around made during subsequent surveys. See recovery plan did not explicitly call for the 640-ac (259-ha) critical habitat area Delisting Criterion 1 and C. Disease or removal of potential geothermal to prevent vehicle entry; Predation for additional discussion development threats outside of (5) Establishment of monitoring regarding the potential for exotic species designated critical habitat, the Service programs to survey habitat and fish introduction into Borax Lake. has acknowledged that geothermal population status; and Downlisting Criterion 2: Permanent development outside critical habitat, but (6) Lack of any new threats to the protection for the 160-acre parcel of in proximity to Borax Lake, may species or ecosystem for 5 consecutive land surrounding and including Borax constitute a potential threat (USFWS years. Lake (T37S, R33E, sec. 14) by TNC or 2012, p. 24). other appropriate public resource Numerous geologic studies have been Recovery Plan Implementation agency. This criterion has been met. In conducted in the vicinity of Borax Lake, Significant conservation objectives 1983, TNC leased two 160-ac (65-ha) yet there is limited detailed information that address the primary threats to the private land parcels, one surrounding regarding the extent of the geothermal Borax Lake chub have been Borax Lake and the other immediately aquifer and the configuration of accomplished through implementing to the north. In 1993, TNC acquired both geothermal fluid flow pathways the 1987 recovery plan, including parcels. TNC also acquired subsurface surrounding Borax Lake (Schneider and protection of the Borax Lake ecosystem mineral rights to the land surrounding McFarland 1995, entire; Fairley et al. from disturbances through acquisition Borax Lake. TNC designated the land 2003, entire; Fairley and Hinds 2004, of key private lands, protection of surrounding Borax Lake, and the 160-ac pp. 827–828; Cummings 1995, pp. 12– subsurface and surface waters, closure (65-ha) parcel to the north, as a preserve 19). As such, the best available scientific of fragile lands to vehicle access, for the purpose of conserving the Borax information does not allow us to removal of livestock grazing, Lake ecosystem. With the purchase of determine the precise geographic monitoring, and other recovery actions. the two parcels by TNC, all lands distance over which geothermal The following discussion summarizes designated as critical habitat are in development may represent a threat to information on recovery actions that public or conservation ownership. The the Borax Lake chub and the Borax Lake have been implemented under each diversion of water for irrigation and ecosystem. Given the lack of scientific downlisting and delisting criterion. livestock grazing within designated information (i.e., depth, extent, source critical habitat ceased. TNC no longer of water, etc.) on the Borax Lake aquifer, Downlisting Criteria permits vehicular access to the preserve a reasonable position is that geothermal Downlisting Criterion 1: The presence except for access for people with development outside of critical habitat of a naturally reproducing population of disabilities or for scientific research. may represent a potential threat to Borax Lake chub in Borax Lake that is In addition to the above, in 1983, the Borax Lake chub and that the closer the free of exotic species. This criterion has BLM designated 520 ac (210 ha) of development is to critical habitat, the been met. To be considered naturally public land surrounding Borax Lake as greater the likelihood that development reproducing, Borax Lake chub need to an ‘‘area of critical environmental could affect the Borax Lake chub and reproduce in their natural habitat in concern’’ (ACEC) to protect Borax Lake the Borax Lake ecosystem. Borax Lake with no human intervention, chub and its habitat. In 2005, the record With the passage of the Steens such as supplementation with hatchery- of decision for the resource management Mountain Cooperative Management and

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Protection Act of 2000 (Steens Act; 16 including: (1) Difficulties in proposing Numerous actions to maintain lake U.S.C. 460nnn et seq.) and the and mitigating a project that would alter levels and restore natural outflows have completion of the Steens Andrews land designated as Visual Resource occurred at Borax Lake since the Borax Resource Management Plan, the BLM Management Class 2 (the visual resource Lake chub was listed. Begun in 1983, has withdrawn the Alvord Known management objective for class 2 is to TNC, with assistance from the BLM and Geothermal Resource Area from mineral retain the existing character of the the ODFW, repaired holes in the and geothermal exploration and landscape, and the level of change to the northern and eastern shorelines of the development (BLM 2005a, p. 49). The characteristic landscape should be low); lake, and deepened the outflow channel Steens Act congressionally designated a (2) the lack of time and staffing to on the southwestern shoreline to ‘‘mineral withdrawal area’’ complete a feasibility analysis; and (3) promote flow to Lower Borax Lake encompassing approximately 900,000 ac the BLM’s requirement that the (USFWS 1987, p. 23). In 1984, the (364,217 ha) on BLM-administered exchange demonstrate a clear public Service and TNC manually constructed lands. The mineral withdrawal area benefit. The BLM suggested the best several channels diverting water from contains the majority of the Alvord route would be to find a geothermal the southwestern outflow channel into Known Geothermal Resource Area resource outside of the mineral the adjacent marsh (USFWS 1987, p. (Alvord KGRA), including Borax Lake withdrawal area and pursue exploration 25). By 2003, there was no open-water and surrounding public lands, with the and development there. Pueblo Valley connection between Borax Lake and exception of 332 ac (134 ha) of BLM- Geothermal LLC subsequently has Lower Borax Lake, but Lower Borax administered land located become inactive and filed to dissolve Lake did contain water at that time approximately 4.5 mi (7.2 km) from their LLC status in the State of Oregon (Williams and Macdonald 2003, p. 7). Borax Lake (BLM 2005a, p. I–2; BLM on December 26, 2013. The only habitat outside of Borax 2005b, p. 4). As stated previously, although the Lake that provides habitat for Borax Private lands within the vicinity of passage of the Steens Act designated a Lake chub is the wetland (referred to as Borax Lake are not affected by the mineral withdrawal area on public ‘‘the marsh’’ in the 1982 listing rule (47 mineral withdrawal. Approximately lands surrounding Borax Lake, it does FR 43957; October 5, 1982)) to the south 2,000 ac (809 ha) of privately owned not include 322 ac (134 ha) of BLM- of Borax Lake, the overflow channel that lands occur within a radius of administered lands and 2,000 ac (809 connects the wetland to Borax Lake, and approximately 1 to 3 mi (1.6 to 4.8 km) ha) of private land located within a a second overflow channel on the from Borax Lake. Based on geothermal radius of approximately 1 to 4.5 mi (1.6 northern end of the lake. Although the development investigated by various to 7.24 km) from Borax Lake. Therefore, entities over the last 3 decades, it is wetland at times maintains water year- while we view this downlisting round, water levels are variable and are reasonable to assume that future criterion as having been met, we geothermal development may be influenced by a groundwater vent in the acknowledge there remains a potential explored on private land in the vicinity wetland and overflow from Borax Lake. for geothermal development on lands of Borax Lake. However, as of 2018 The seasonal pattern and overall not formally withdrawn from there are no active proposals in place for contribution of groundwater inputs to geothermal or mineral development in such development (A. Mauer, in litt. the wetland are not understood. In the Alvord Basin and that future 2018). September 2015, the wetland was dry, The most recent exploration for development of these resources due in part from reduced flow from geothermal resource development constitutes a potential threat to Borax Borax Lake caused by a vegetation plug occurred in 2008, when the BLM Lake chub. That said, we have in the overflow channel and presumably received an inquiry from Pueblo Valley determined the likelihood of this threat no or reduced contribution from Geothermal LLC regarding permitting becoming operative in the foreseeable groundwater. Later that fall, the wetland processes for geothermal exploratory future is low. was observed to be full, presumably due drilling and the potential for developing See Delisting Criterion 3 and D. The to increased groundwater inputs. In a geothermal electrical generation plant Inadequacy of Existing Regulatory response to the reduced flow in the in the Alvord Lake basin potentially Mechanisms for additional discussion overflow channel, the ODFW manually within 3 to 5 mi (4.8 to 8.0 km) of Borax regarding the threat of geothermal removed vegetation in spring 2016, to Lake. Pueblo Valley Geothermal LLC resource development. provide a more consistent flow through submitted a proposal to the BLM on Downlisting Criterion 4: the overflow channel (P. Scheerer 2016, January 31, 2012, for a binary Reestablishment of ponds and natural pers. comm.). Therefore, while geothermal plant that would produce 20 marshes adjacent to Borax Lake in order groundwater inputs to the wetland are to 25 megawatts. Pueblo Valley to create more chub habitat, and unpredictable, the increased flow Geothermal LLC also sought to acquire reestablishment of Lower Borax Lake by through the overflow channel due to approximately 3,360 ac (1,360 ha) of waters from Borax Lake in order to manual vegetation removal by the BLM land via land exchange in order to create more habitat. This criterion has ODFW is anticipated to increase the develop their project. The BLM been met with the exception of the likelihood of maintaining habitat in the responded with a letter (Karges in litt. reestablishment of Lower Borax Lake. wetland for the Borax Lake chub. While 2012) explaining that the BLM-managed However, the 5-year review (USFWS the wetland and several overflow lands surrounding the private lands 2012, pp. 7, 26) concluded that Lower channels do not represent a large under lease are part of the Leasable and Borax Lake does not provide suitable amount of habitat for the Borax Lake Saleable mineral withdrawal enacted by habitat for Borax Lake chub due to chub, they are potentially important the Steens Act and implemented under desiccation during summers with low cool-water refuge habitats during the Steens Mountain Cooperative precipitation and to unsuitable habitat periods of above-average air Management and Protection Area in the winter due to freezing. As a temperatures when suitable cool-water Resource Management Plan. The BLM result, we no longer consider habitat in Borax Lake may be reduced. informed Pueblo Valley Geothermal LLC reestablishment of Lower Borax Lake to An associated discussion can be found that they would not be able to complete be a necessary action for Borax Lake under Delisting Criterion 1 and A. The an exchange for various reasons, chub recovery. Present or Threatened Destruction,

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Modification, or Curtailment of Its on an assessment of the need for annual demographic resilience, is relatively Habitat or Range in this proposed rule. population data in relation to potential common for small desert fishes Delisting Criteria take associated with monitoring.) The (Winemiller 2005, pp. 878–879). In the population is naturally sustaining case of the Borax Lake chub, population In addition to the four downlisting without the need for supplementation, variation likely results from a criteria, the recovery plan also such as propagation in a hatchery or in combination of short life span and identified six additional criteria for aquaria. occurrence in water temperatures at the delisting. Delisting Criterion 1: A viable, self- The Borax Lake chub is a species that edge of the species’ thermal tolerance. sustaining population of Borax Lake demonstrates high annual variability in Given our improved knowledge of chub, which is defined as a naturally population abundance, ranging from a natural variability as described above, sustaining population that is free of low of 1,242 estimated fish in 2015, to we have concluded that the portion of exotic species and fluctuates in size a high of 76,931 in 2017 (see table, this delisting criterion that called for within the seasonal ranges observed in below). As recently as 2010 and 2011, population levels to fluctuate within the 1986 to 1987. This criterion has been the population estimates were 25,489 narrow range of population estimates met. Data collected from 1986 through and 26,571, respectively. Prior to 2015, conducted in 1986 and 1987 is 2017 show a self-sustaining population the lowest population estimate was unrealistic, and is no longer reasonable persists at Borax Lake. (In 2013 and 4,132 in 1988. Such population to maintain as a recovery goal for this 2014, surveys were not conducted based variability, with opportunistic species.

TABLE OF POPULATION MARK—RECAPTURE ESTIMATES FOR BORAX LAKE CHUB FROM 1986 TO 2017, INCLUDING ADJUSTED LINCOLN-PETERSON AND HUGGINS CLOSED CAPTURE MODELS (1)

Lower 95% Upper 95% Year (2) Estimate confidence confidence limit limit

1986 ...... 15,276 13,672 17,068 1987 ...... 8,578 7,994 9,204 1988 ...... 4,132 3,720 4,589 1989 ...... 14,052 13,016 15,172 1990 ...... 19,165 18,117 20,273 1991 ...... 33,000 31,795 34,251 1992 ...... 25,255 24,170 26,388 1993 ...... 35,650 34,154 37,212 1994 ...... 13,421 12,537 14,368 1995 ...... 35,465 33,533 37,510 1996 ...... 8,259 7,451 9,153 1997 ...... 10,905 10,377 11,459 2005 ...... 14,680 12,585 17,120 2006 ...... 8,246 6,715 10,121 2007 ...... 9,384 7,461 11,793 2008 ...... 12,401 10,681 14,398 2009 ...... 14,115 12,793 15,573 2010 ...... 25,489 23,999 27,071 2011 ...... 26,571 24,949 28,301 2012 ...... 9,702 9,042 10,452 2015 ...... 1,242 1,077 1,456 2016 ...... 9,003 8,045 10,560 2017 ...... 76,931 68,444 86,952 (1) Adjusted Lincoln-Peterson and Huggins closed capture models are referenced in Scheerer et al. 2012, p. 7. See Salzer 1992, p. 17; Salzer 1997, no pagination; Scheerer and Bangs 2011, p. 4; Scheerer et al. 2012, pp. 6–7; Scheerer et al 2015, p. 3; Scheerer et al. 2016, p. 5; and M. Meeuwig in litt. 2017. (2) Surveys were not conducted from 1998 to 2004, and from 2013 to 2014.

In the summer of 2015, above-average Borax Lake chub survival and temperatures may have contributed to air temperatures may have influenced recruitment appear to be higher during the substantial decline in Borax Lake water temperatures in Borax Lake, years when lake temperatures are chub abundance observed between 2012 causing a population decline. In 2016, cooler. In prior years, when Borax and 2015 (Scheerer et al. 2016, p. 9). In however, perhaps supported by cooler Lake’s daily maximum water late July through the rest of the summer air and water temperatures, the temperatures were substantially cooler 2015, and in the mid to late summer of population estimate rebounded to over than the 12-year average (for example, 2016, water temperatures in the lake 9,000 individuals (Scheerer et al. 2016, in 2010 and 2011, there were fewer days were typically at or below the 12-year p. 3). These observations indicate that above the 12-year mean), Borax Lake average, which may have contributed to temperature may annually affect Borax chub abundance estimates exceeded improved Borax Lake chub survival and Lake chub survival and abundance in 25,000 fish and were some of the the significant increase in abundance Borax Lake. Borax Lake chub frequently highest abundance estimates recorded (625 percent) observed in 2016 experience water temperatures that are (Scheerer et al. 2016, p. 8). Borax Lake (Scheerer et al. 2016, p. 8). The at or near their thermal critical water temperatures were substantially population estimate in 2017 was 76,931, maximum of 34.5 °C (94.1 °F) (Williams higher than the 12-year average in June the largest count on record (M. Meeuwig and Bond 1983, p. 412). Therefore, and July of 2015. The elevated in litt. 2017). While air and water

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temperature information for 2017 has Delisting Criterion 4: Establishment of hydrologic information, substrate not been analyzed, given the recent a fence around the 640-acre critical mapping, outflow monitoring, tracking trend of increasing abundance and prior habitat area to prevent vehicle entry. of water levels, and geological and slope observations, we speculate lake This criterion has been mostly met. The stability, were gathered in the 1990s temperatures were likely cooler than the Andrews/Steens Resource Area, Burns (Scoppettone et al. 1995; Wilson 2000). 12-year average during 2017. Thus, District BLM, has constructed facilities The Service, ODFW, and BLM while the 2015 estimate of 1,242 fish to modify public access and enhance collaboratively developed the Borax represents the lowest estimate on public understanding of the Borax Lake Lake Chub CMP to outline individual record, the pattern of variability area. The Burns District BLM closed agency roles and responsibilities, and observed over 3 decades of monitoring access roads in the vicinity of Borax commitments into the future, regarding population abundance underscores the Lake, realigned the fence surrounding Borax Lake chub, the Borax Lake resiliency of this species and its ability Borax Lake to limit vehicle access, and ecosystem, and surrounding lands to rebound quickly (see table, above). designated visitor parking. Partial (USFWS et al. 2018). While this With one exception, periodic surveys funding for the fencing project came proposed rule does not rely on the CMP, since 2005 have not identified any from the BLM’s Threatened and the CMP significantly enhances progress exotic species within Borax Lake Endangered Species Recovery Fund, an made towards meeting this delisting (Scheerer and Jacobs 2005, 2006, 2007, initiative started in 2010 that supports criterion and other delisting criteria, 2008, 2009, and 2010; Scheerer and projects targeting key recovery actions including ongoing conservation actions. Bangs 2011; Scheerer et al. 2012, 2015, for federally listed and candidate Delisting Criterion 6: Lack of any new and 2016). However, in 2013, during species occurring on BLM lands. The threats to the species or ecosystem for shoreline surveys conducted by the BLM plans to install interpretive signs 5 consecutive years. This criterion has ODFW, biologists noted a large fish with at the designated parking area (USFWS been met. Although this proposed rule paired dorsal fins (presumably a bass) et al. 2018, p. 7). The lake is now identifies climate change as a new potential stressor in the future, we have (Scheerer et al. 2013, p. 10). No completely enclosed by fencing, determined it is not operative on the additional sightings of the bass occurred although approximately 30 ac (12 ha) of species or its habitat currently, and is during the ODFW surveys (S. Hurn in critical habitat remains outside the not anticipated to negatively affect the litt. 2014, unpaginated) or during fenced portion of the critical habitat, species in the foreseeable future. While subsequent efforts to capture the bass leaving approximately 0.6 mi (1 km) of potential increases in ambient air (see C. Disease or Predation, below). road accessible to vehicles within temperatures may cause warming of Survival of the bass is believed to be designated critical habitat. The Borax Lake water or, more accurately, unlikely given the high water remaining area of the critical habitat slow the cooling of the geothermal temperatures in Borax Lake. No known will remain unfenced to provide for waters, we anticipate that thermal vehicle access, parking, and occurrence of disease or predation refuge associated with shallow margin interpretative signs, while still affecting the population of Borax Lake habitat and cool and cold water vents in protecting the Borax Lake environment. chub has occurred since the time of the lake along with the species’ ability The BLM and ODFW will continue to listing (47 FR 43957; October 5, 1982). to rebound quickly following periods of assess the effectiveness of the vehicle The best available scientific data higher than normal air and water closure for protection of the Borax Lake indicate Borax Lake chub are a viable, temperatures, will provide resilience area. Barring any new information self-sustaining population in habitat against any future potential effects of indicating that the existing fencing is currently free from exotic species. climate change. See our discussion Delisting Criterion 2: Permanent insufficient to protect the Borax Lake under A. The Present or Threatened protection for the 160-acre parcel of chub, fencing of the remaining critical Destruction, Modification, or land to the north of Borax Lake (T37S, habitat appears to be unnecessary. Curtailment of Its Habitat or Range, R33E, sec. 11) by TNC or other Delisting Criterion 5: Establishment of below, for a more detailed description appropriate public resource agency. monitoring programs to survey habitats on potential effects of climate change. This criterion has been met. In 1983, and fish population status. This TNC leased two 160-ac (65-ha) private criterion has been met. Numerous Summary of Factors Affecting the land parcels, one surrounding Borax studies of the ecology and habitat of Species Lake and the other immediately to the Borax Lake have been conducted (Salzer Section 4 of the Act and its north of the lake. TNC purchased these 1992; Scoppettone et al. 1995; Furnish implementing regulations (50 CFR part two parcels in 1993, placing both et al. 2002; Scheerer and Jacobs 2005, 424) set forth the procedures for listing parcels in public or conservation 2006, 2007, 2008, 2009, 2010; Scheerer species, reclassifying species, or ownership and protection. and Bangs 2011; Scheerer et al. 2012, removing species from listed status. Delisting Criterion 3: Withdrawal of 2013). TNC conducted abundance ‘‘Species’’ is defined by the Act as Borax Lake waters from appropriations. estimates from 1986 through 1997. The including any species or subspecies of This criterion has been met. With the ODFW conducted mark-recapture fish or wildlife or plants, and any acquisition of Borax Lake by TNC, population surveys from 2005 through distinct vertebrate population segment surface waters on their land cannot be 2012, and again in 2015 and 2016; of fish or wildlife that interbreeds when appropriated by others. Additionally, in developed a survey protocol; and mature (16 U.S.C. 1532(16)). A species 1991, the ODFW filed an application for recommended a long-term monitoring may be determined to be an endangered the water rights to Borax Lake for strategy (Scheerer and Jacobs 2005, or threatened species because of any one conservation purposes. The water right 2006, 2007, 2008, 2009, 2010; Scheerer or a combination of the five factors was certified and issued to the Oregon and Bangs 2011; Scheerer et al. 2012, described in section 4(a)(1) of the Act: Water Resources Department on 2013, 2015, 2016). The ODFW also (A) The present or threatened December 16, 1998, for the purpose of conducted surveys to monitor the destruction, modification, or providing habitat for the Borax Lake condition of the lake shoreline, curtailment of its habitat or range; (B) chub (Oregon Water Resources outflows, and adjacent wetlands. overutilization for commercial, Department in litt. 2018). Additional physical data, including recreational, scientific, or educational

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purposes; (C) disease or predation; (D) upwards of 30 years which, when A. The Present or Threatened the inadequacy of existing regulatory combined with our knowledge of factors Destruction, Modification, or mechanisms; or (E) other natural or affecting the species, allows us to Curtailment of Its Habitat or Range human made factors affecting its reasonably predict future conditions, continued existence. We must consider albeit with diminishing precision over At the time of listing in 1982 (47 FR these same five factors in delisting a time. Given the best available scientific 43957; October 5, 1982), the primary species. We may delist a species and commercial information, for the threats to the Borax Lake chub consisted according to 50 CFR 424.11(d) if the best purposes of this proposed rule we of potential impacts from geothermal available scientific and commercial data consider the foreseeable future for Borax energy development on BLM and indicate that the species is neither Lake chub to be a range of 20 to 30 private lands near Borax Lake, diversion endangered nor threatened for the years. of the lake’s outflows by alteration of the shoreline crust, and potential following reasons: (1) The species is We also expect the ODFW, BLM, and extinct; (2) the species has recovered development of a recreation facility. TNC to continue to manage Borax Lake Since the time of listing, actions have and is no longer endangered or and to conserve Borax Lake chub for the threatened; and/or (3) the original been taken to reduce or eliminate these foreseeable future. This expectation is threats, as discussed below. We also scientific data used at the time the based on the fact that for over 3 decades, species was classified were in error. include an analysis of the effects of the ODFW, BLM, and TNC have taken A recovered species is one that no climate change as a potential threat in actions benefiting the Borax Lake chub longer meets the Act’s definition of the foreseeable future. and the Borax Lake ecosystem. endangered or threatened. Determining Recreation, Water Diversion, and In considering what factors might whether a species is recovered requires Shoreline Habitat Alteration consideration of the same five categories constitute threats, we must look beyond of threats specified in section 4(a)(1) of the exposure of the species to a The recreation facility discussed in the Act. For species that are already particular factor to evaluate whether the the 1982 listing rule was never listed as endangered or threatened, this species may respond to the factor in a developed, and acquisition of the analysis of threats is an evaluation of way that causes actual impacts to the property by TNC eliminated the both the threats currently facing the species. If there is exposure to a factor potential for development of a species and the threats that are and the species responds negatively, the recreation facility at the Borax Lake site reasonably likely to affect the species in factor may be a threat, and during the (Williams and Macdonald 2003, p. 12). the foreseeable future following status review, we attempt to determine The ODFW filed for water rights at delisting or downlisting (i.e., how significant a threat it is. The threat Borax Lake in 1991, and that water right reclassification from endangered to is significant if it drives or contributes is now certified to the Oregon Water threatened) and the removal or to the risk of extinction of the species, Resources Department, to prevent reduction of the Act’s protections. such that the species warrants listing as further attempts at diverting the water A species is ‘‘endangered’’ for endangered or threatened as those terms and to ensure maintenance of the water purposes of the Act if it is in danger of are defined by the Act. However, the elevation in Borax Lake (see Delisting extinction throughout all or a identification of factors that could Criterion 3 discussion, above). The ‘‘significant portion of its range’’ and is impact a species negatively may not be purpose of the water right is to provide ‘‘threatened’’ if it is likely to become sufficient to compel a finding that the the required habitat conditions for endangered within the foreseeable species warrants listing. The Borax Lake chub. The right is future throughout all or a ‘‘significant information must include evidence established under Oregon Revised portion of its range.’’ The word ‘‘range’’ sufficient to suggest that the potential Statute 537.341, with a priority date of in the significant portion of its range threat is likely to materialize and that it August 21, 1991. The right is limited to phrase refers to the general geographical has the capacity (i.e., it should be of the amount of water necessary to area in which the species occurs at the sufficient magnitude and extent) to maintain a surface water elevation of time a status determination is made. For affect the species’ status such that it the purposes of this analysis, we will 4,081 ft (1,244 m) above mean sea level. meets the definition of endangered or For purposes of water distribution, the evaluate whether the currently listed threatened under the Act. species, the Borax Lake chub, should be instream right shall not have priority In examining threats to narrowly considered endangered or threatened. over human or livestock consumption. The Act does not define the term distributed endemic species such as The right has been recorded in the State ‘‘foreseeable future.’’ For the purpose of Borax Lake chub, we must also consider record of Water Right Certificates as this proposed rule, we define the that natural rarity (i.e., a species that 75919 (Oregon Water Resources ‘‘foreseeable future’’ to be the extent to only exists in one or a few locations, Department in litt. 2018). which, given the amount and substance thought it may be abundant there), in The 160-ac (65-ha) private land parcel of available data, we can anticipate and of itself, does not constitute a threat containing Borax Lake was purchased events or effects, or reliably extrapolate under the Act. Natural rarity may by TNC in 1993. Subsurface mineral threat trends, such that we reasonably increase risk or vulnerability if threats rights are included. Since TNC believe that reliable predictions can be are operative on the species or its acquisition, surface waters on their made concerning the future as it relates habitat now or in the foreseeable future, land, upon which Borax Lake is located, to the status of the Borax Lake chub. In but rarity alone, in the absence of an can no longer be appropriated by others. considering the foreseeable future as it operative threat, does not warrant Additionally, TNC ended the practice of relates to the status of the Borax Lake protection to a species under the Act. actively diverting surface water from the chub, we consider the factors affecting In the following analysis, we evaluate eastern side of the lake to reduce the the Borax Lake chub, historical the status of the Borax Lake chub impact from prior water diversions. The abundance trends, and ongoing through the five-factor analysis of BLM designated the adjacent 600 ac conservation efforts. Our period of threats currently affecting, or that are (243 ha) of public lands as an ACEC for record for monitoring the Borax Lake likely to affect, the species within the the conservation of Borax Lake chub, chub and its associated habitat extends foreseeable future. and the area was fenced to exclude

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livestock grazing (see Downlisting developer, Pueblo Valley Geothermal not active (P. Hall 2014, pers. comm.). Criterion 2 discussion, above). LLC, met with the BLM in 2008, to The Oregon Secretary of State Office Off-road vehicle damage along the discuss their interest in obtaining an maintains an online business registry of lake shoreline has been documented in ROW permit to access private land and Limited Liability Company (LLC) the past (Scheerer and Jacobs 2005, p. 6; construct a power plant. Although the companies. The list was consulted, and 2006, p. 7; 2007, p. 6; 2008, p. 6; 2009, Steens Act and subsequent RMP we found that the company, Pueblo p. 8; 2010, p. 4; Scheerer and Bangs withdrew the Alvord Known Valley Geothermal LLC, filed an article 2011, p. 9; Scheerer et al. 2012, p. 13; Geothermal Resource Area from of dissolution on December 26, 2013. A Scheerer et al. 2013, p. 6). As a result, geothermal development, the RMP review of the Harney County Assessor’s in 2011, the BLM and TNC completed could allow a ROW permit because the property records show that 320 ac (129 a perimeter fence surrounding the lake area in question is not within the ha) of land previously leased by Pueblo and most of the associated critical Cooperative Management and Protection Valley LLC, which is approximately 1 habitat to exclude unauthorized Area boundary. ROWs are a valid use of mi (1.6 km) west of Borax Lake, is now vehicles, and in 2013, they installed public lands under sections 302 and 501 owned by Oregon Geothermal LLC. We locks on all access gates. Due to the of the Federal Land Policy and do not have any new information on completion of the perimeter fence, the Management Act of 1976 (43 U.S.C. permit applications from Oregon threat to Borax Lake chub and its habitat 1701 et seq.), as amended (BLM 2005a, Geothermal LLC or any other new from shoreline habitat alteration by p. 59). The BLM would be responsible geothermal proposals that may arise in vehicles has been addressed. under the National Environmental the foreseeable future. Potential impacts resulting from Geothermal Development Policy Act (42 U.S.C. 4321 et seq.) to analyze any proposed ROW project, geothermal development that were Geothermal exploration and including the connected actions, such as identified at the time of listing include development has been pursued in the exploratory well drilling and power line effects to water elevation in Borax Lake Alvord Known Geothermal Resource construction. due to the interconnecting aquifers or Area and specifically in the vicinity of The proposed power plant was springs. Drilling could disrupt the hot Borax Lake from the early 1970s anticipated to generate 1 to 10 water aquifer that supplies Borax Lake. (Wassinger and Koza 1980, p. 1) to 2013. megawatts. Pueblo Valley Geothermal Potential impacts from geothermal The Alvord Known Geothermal LLC acquired a 53-year lease on energy drilling could include changes to Resource Area is a 176,835-ac (71,563- approximately 2,000 ac (809 ha) from the aquifer pressure or temperature and ha) area within the Alvord Basin landowners located south of Alvord the potential to lessen or eliminate (Wassinger and Koza 1980, p. 7). Lake, and within 3 mi (4.8 km) and as inflows to the lake from the geothermal Development of geothermal resources close as 1 mi (1.6 km) from Borax Lake aquifer. Changes to water flow and was considered in 1980, and exploratory (P. Hall 2009, pers. comm.). Pueblo water temperature may have an adverse wells were drilled in 1982 (47 FR 43957; Valley Geothermal LLC also placed an impact on the Borax Lake chub. October 5, 1982). In 1994, Anadarko advertisement in the publication Although the species tolerates thermal proposed additional geothermal ‘‘Geothermal Energy Weekly’’ seeking waters, excessive warming of the lake’s exploration and development, and the investors for a 20- to 25-megawatt water could cause adverse effects, and, BLM prepared a notice of intent to geothermal facility (Geothermal Energy at extremes, would be lethal to the prepare an environmental impact Association 2010, no pagination). The Borax Lake chub. statement (EIS). After receiving public developer indicated in 2011 that they In summary, proposals to develop scoping comments, Anadarko withdrew were progressing with resource geothermal energy resources in the its development proposal, and no EIS assessments regarding the total Borax Lake vicinity have occurred was written (T. Geisler 2009, pers. megawatt and economic potential (P. sporadically in the 1970s, in the 1980s, comm.). Hall 2011, pers. comm.). No formal in 1994, and in 2008 through 2012. The passage of the Steens Act in 2000, permit applications were received by However, none of these proposals has and the finalization of the BLM the BLM or DOGAMI in 2011 (R. moved forward with permitting and Resource Management Plan (RMP) (BLM Houston 2008, pers. comm.; 2010, pers. implementation over a 4-decade period, 2005a, p. 71), withdrew mineral and comm.; R. Houston in litt. 2011), and as and this history leads us to conclude geothermal resources from development of 2018 we are not aware of such (A. that the likelihood of geothermal energy on Federal lands within the Alvord Mauer, in litt. 2018). development now and in the foreseeable Known Geothermal Resource Area. The Pueblo Valley Geothermal LLC future is low. Furthermore, while BLM retained 332 ac (134 ha) of land submitted an informal proposal to the geothermal development in the vicinity with high potential for geothermal BLM on January 31, 2012, seeking to of Borax Lake has been considered a resources west of Fields and within 4.5 acquire 3,360 ac (1,360 ha) of BLM land potential threat to the Borax Lake chub, mi (7.2 km) of Borax Lake open for in the vicinity of the Borax Lake the precise effects of possible leasable mineral and geothermal geothermal aquifer in the interest of geothermal development on the species development (BLM 2005a, p. I–2). developing an air-cooled binary are uncertain and unpredictable. The Private lands within this area are not geothermal plant to produce 20 to 25 potential effects to the species would affected by the mineral withdrawal. megawatts of electricity (T. McLain in depend upon the specifics, such as the In 2008, the BLM and DOGAMI litt. 2012). The BLM responded with a scale of the project and proximity to received inquiries on behalf of private letter on March 14, 2012, explaining Borax Lake, of any geothermal energy landowners in Alvord Basin regarding that due to various reasons including development that might proceed to the the development of geothermal resource concerns, funding, and staffing implementation phase. Depending on resources. The BLM was contacted priorities, such a land exchange was not the particular circumstances of any regarding electrical transmission and feasible at that time (Karges in litt. particular project, such development right-of-way (ROW) access to cross BLM 2012). Pueblo Valley Geothermal LLC could potentially have a negative effect lands in order to explore and develop indicated to us that the proposal to on the species, or it might have no or commercial geothermal electrical power develop geothermal energy on private negligible effects. The effects of any (K. Bird 2008, pers. comm.). The land in the vicinity of Borax Lake was future geothermal project proposal on

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Borax Lake chub would be assessed impacts from, climate-associated temperatures since 2012 and lower based on specific project details and changes in environmental conditions population abundance during this time other data available at the time. If an can be used to help devise appropriate provide additional evidence towards assessment suggested a future strategies for its recovery. this potential relationship between geothermal project would likely cause Global climate projections are water temperatures and annual survival significant risk to Borax Lake and the informative and, in some cases, the only rates (Scheerer et al. 2015, p. 8). The well-being of Borax Lake chub, and or the best scientific information lowest estimated population abundance existing regulatory mechanisms did not available for us to use. However, on record (1,242) for Borax Lake chub deter or result in modifications to the projected changes in climate and related occurred in 2015, following development to minimize or eliminate impacts can vary substantially across unseasonably warm air and water likelihood of impacts to the chub, we and within different regions of the temperatures in June and July of that have the discretion to use the world (e.g., IPCC 2007, pp. 8–12). year in conjunction with reduced access emergency listing authorities under Therefore, we use ‘‘downscaled’’ to cool water refugia through the section 4(b)(7) of the Act, such as we projections when they are available and overflow channel (Scheerer et al. 2016, used in the May 28, 1980, emergency have been developed through p. 8). A similar die-off was suspected to listing of Borax Lake chub (45 FR appropriate scientific procedures, have occurred in July 1987, during a 35821). The possibility of geothermal because such projections provide higher period of unseasonably warm development in the vicinity of Borax resolution information that is more temperatures when mortalities were Lake will continue to represent a relevant to spatial scales used for documented and fish were observed potential threat to Borax Lake chub and analyses of a given species (see Glick et congregating in the coolest portions of its habitat, but we have determined the al. 2011, pp. 58–61, for a discussion of the lake (Scheerer et al. 2015, pp. 6–7). likelihood of this threat becoming downscaling). In 2016, water temperatures and air operative in the foreseeable future is With regard to our analysis for the temperatures were cooler than average low. Borax Lake chub, we evaluated and the overflow channel had been downscaled projections from the cleared; the population of Borax Lake Effects of Climate Change National Climate Change Viewer (Alder chub then rebounded to an estimated The terms ‘‘climate’’ and ‘‘climate and Hostetler 2014, 2017). These 9,003 individuals (Scheerer et al. 2016, change’’ are defined by the projections are based on the mean of 30 p. 3), similar to previous rebounds Intergovernmental Panel on Climate models that can be used to predict following population declines. Change (IPCC). ‘‘Climate’’ refers to the changes in air temperature for the Although a specific analysis has not mean and variability of different types Alvord Lake basin in Harney County, been conducted to determine the of weather conditions over time, with 30 Oregon. The models predict that during amount and suitability of thermal refuge years being a typical period for such the period from 2025 to 2049, the July habitat that may be available under measurements, although shorter or mean maximum air temperature will various lake temperature conditions, longer periods also may be used (IPCC increase by 2.4 °C (4.3 °F) from the information presented in Scheerer and 2007, p. 78). The term ‘‘climate change’’ historical mean, and the January mean Bangs 2011, pp. 5–8, and Scheerer et al. thus refers to a change in the mean or minimum air temperature will increase 2012, pp. 7–11, suggest the availability variability of one or more measures of by 2.3 °C (4.1 °F). The model predicts of shallow margin habitat around the climate (e.g., temperature or very little change in the mean annual perimeter of the lake, along with the precipitation) that persists for an precipitation and runoff for the Alvord outflow channel and wetland, likely extended period, typically decades or Lake basin (Alder and Hostetler 2014, provide thermal refuge (i.e., cooler longer, whether the change is due to pp. 3–5; 2017, unpaginated). water) habitat for the species during natural variability, human activity, or Increases in ambient air temperatures these events. In addition, monitoring by both (IPCC 2007, p. 78). Various types may cause warming of Borax Lake water the ODFW in 2011 and 2012 of changes in climate can have direct or or, more accurately, slow the cooling of documented cool and cold water vents indirect effects on species. These effects the geothermal waters. During the within portions of the lake that likely may be positive, neutral, or negative and warmest times of the year, this may contribute to moderating lake they may change over time, depending reduce the amount and suitability of temperatures and provide additional on the species and other relevant habitat available for Borax Lake chub areas of thermal refuge (P. Scheerer, considerations, such as the effects of because Borax Lake chub use the edges pers. comm. 2018). While there is interactions of climate with other of the lake, areas around cool and cold evidence these cool and cold water variables (e.g., habitat fragmentation) water vents within the lake, several vents, as well as warm and hot vents (IPCC 2007, pp. 8–14, 18–19). In our overflow channels, and a wetland where within the lake (in addition to the analysis, we use expert judgment to waters are shallower and the primary vent) vary in temperature year weigh relevant information, including temperatures have cooled from the to year, the aggregate of these thermal uncertainty, in our consideration of geothermal source to suitable water refuge habitats, along with the species’ various aspects of climate change. temperatures for Borax Lake chub ability to rebound quickly following As is the case with all stressors we survival. Scheerer et al. (2015, p. 9) periods of higher than normal air and assess, even if we conclude that a suggested there is likely a correlation water temperatures, are anticipated to species is currently affected or is likely between water temperatures and chub provide resilience against potential to be affected in a negative way by one population abundance. Monitoring of future effects of climate change. or more climate-related impacts, it does lake temperatures since 2005 indicates Changes to precipitation, drought, not necessarily follow that the species that high population abundance in 2010 aquifer recharge, or vegetative meets the definition of an ‘‘endangered and 2011 (greater than 25,000 community around Borax Lake as a species’’ or a ‘‘threatened species’’ individuals) correspond with lake result of climate change would not under the Act. If a species is listed as temperatures that were cooler during likely have an impact on the Borax Lake endangered or threatened, knowledge this period when compared to chub. Borax Lake is perched above the regarding the vulnerability of the temperatures recorded in 2006 to 2009 valley floor, there is no inflow of water species to, and known or anticipated and 2012 to 2016. Higher water from above-ground sources, and the

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vegetative community is not likely to margin habitat and cool and cold water of the Act requires that the Service take change due to the temperature increases vents in the lake along with the species’ into account ‘‘those efforts, if any, being predicted. ability to rebound quickly following made by any State or foreign nation, or periods of higher than normal air and any political subdivision of a State or Summary of Factor A water temperatures, will provide foreign nation, to protect such species Since the time of listing in 1982 (47 resilience against potential future effects . . .’’ In relation to Factor D under the FR 43957; October 5, 1982), actions of climate change. Act, we interpret this language to have been taken to reduce or eliminate require the Service to consider relevant B. Overutilization for Commercial, the destruction and modification of Federal, State, and Tribal laws, Recreational, Scientific, or Educational Borax Lake chub habitat. This includes regulations, and other such binding Purposes the acquisition of Borax Lake and legal mechanisms that may ameliorate surrounding lands by TNC, the BLM’s Overutilization for commercial, or exacerbate any of the threats we designation of adjacent lands as an recreational, scientific, or educational describe in threat analyses under the ACEC, protection of subsurface and purposes was not a factor in listing (47 other four factors or otherwise enhance surface waters, protection from mineral FR 43957; October 5, 1982) and is the species’ conservation. Our withdrawal, and closure of fragile lands currently not known to be a threat to the consideration of these mechanisms is to livestock grazing and unauthorized Borax Lake chub, nor is it likely to described in detail within each of the vehicle access. Although these measures become so in the foreseeable future. threats or stressors to the species (see have removed and minimized various C. Disease or Predation full discussion under this section, threats to Borax Lake and surrounding Summary of Factors Affecting the lands, the potential for geothermal Disease was not a factor in listing of Species). development, and consequent possible the Borax Lake chub (47 FR 43957; The following provides an overview impacts to Borax Lake chub and its October 5, 1982) and is currently not of the existing regulatory protections habitat, remains. The possibility of known to be a threat to Borax Lake that protect the Borax Lake ecosystem geothermal development in the vicinity chub, nor is it likely to become so in the and Borax Lake chub. of Borax Lake will continue to represent foreseeable future. a potential threat to Borax Lake chub Likewise, predation was not noted as The Nature Conservancy and its habitat, but we have determined a factor in the listing of Borax Lake chub The 160-ac (65-ha) private land parcel the likelihood of this threat becoming (47 FR 43957; October 5, 1982). containing Borax Lake and the 160-ac operative in the foreseeable future is Although we do not believe predation is parcel to the north were purchased by low. a threat currently or in the foreseeable TNC in 1993. Subsurface mineral rights Increase in the ambient air future, a single observation of an exotic are included. Since TNC acquisition, temperature from climate change could fish did occur in 2013 (see Delisting surface waters on their land, upon slow the cooling of the geothermal Criterion 1, above, for more discussion). which Borax Lake is located, can no waters that create Borax Lake. Cooling Exotic fish were not observed in longer be appropriated by others. of the waters of Borax Lake, especially repeated surveys, and no known Additionally, TNC ended the practice of the shallow margin areas including impacts to Borax Lake chub occurred. actively diverting surface water from the several overflow channels and the The high water temperatures in Borax eastern side of the lake to reduce the wetland, is important to the Borax Lake Lake, which likely limited the long-term impact from prior water diversions. chub during warm times of the year survival of this exotic fish, also limit the BLM—Federal Land and Rights-of-Way given that temperatures in some areas of overall likelihood of establishment of the lake often exceed the thermal exotic species in Borax Lake. The The passage of the Steens Act of 2000 maximum for this species (Scheerer and establishment of a perimeter fence and the completion of the Steens Bangs 2011, p. 8) reported as 34.5 around Borax Lake by the BLM and TNC Andrews Resource Management Plan degrees Celsius (94 degrees Fahrenheit) in 2011 further reduced the likelihood (RMP) withdrew the Alvord KGRA from (Williams and Bond 1983, p. 412). of purposeful or accidental mineral and geothermal exploration and Above-average air temperatures in the introductions of exotic species to the development (BLM 2005). The Steens summer of 2015 correlate with the extent that we conclude that the threat Act congressionally designated a above-average water temperatures of predation has been addressed. mineral withdrawal area encompassing documented in Borax Lake during the As noted previously in this proposed 900,000 ac (364,217.1 ha) of the same time frame and may have rule, the BLM, ODFW, and the Service planning area on BLM-administered contributed to the low population developed a CMP that will guide future lands. The mineral withdrawal area estimate that fall (Scheerer et al. 2016, monitoring for nonnative species, contains the majority of the Alvord p. 9). In the future, changes in water monitoring of Borax Lake chub, vehicle KGRA, including Borax Lake and temperature due to increases in ambient access restrictions, and public outreach surrounding public lands, with the air temperatures caused by climate and education (USFWS et al. 2018). exception of 332 ac (134.4 ha) located change could result in a reduction in the While the CMP provides agency approximately 4.5 mi (7.242 km) from amount of habitat available at suitable commitments for long-term stewardship Borax Lake (BLM 2005). Private lands water temperatures, thus reducing the of Borax Lake and Borax Lake chub, this within this area are not affected by the overall amount of habitat available for proposed rule does not rely on the mineral withdrawal. Approximately the Borax Lake chub during warm actions described in the CMP. 2,000 ac (809.4 ha) of privately owned periods of the year. It is reasonable to land occur within a 3-mi (4.83-km) assume the frequency of these events D. The Inadequacy of Existing radius of Borax Lake and are not subject due to climate change may increase Regulatory Mechanisms to BLM’s withdrawal. The BLM has such that there is a possibility for Under this factor, we examine the responsibility to review all applications consecutive year events of drought and stressors identified within the other for geothermal development within the associated abnormally warm air and factors as ameliorated or exacerbated by Alvord KGRA that occur on BLM lands water temperatures. We anticipate that any existing regulatory mechanisms or and some applications for development thermal refuge associated with shallow conservation efforts. Section 4(b)(1)(A) on private lands if the development

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requires ROW for access or transmission developer is required by DOGAMI to ‘‘take’’ (killing or obtaining possession lines across BLM-managed lands. ROWs provide baseline information needed to or control) of listed species without an are a valid use of public lands under show there would be no connection to incidental take permit. The State of sections 302 and 501 of the Federal geothermal or groundwater continuity Oregon determined that Borax Lake Land Policy and Management Act of in areas of environmental concern (i.e., chub fit the definition of threatened 1976 (BLM 2005). The BLM would be Borax Lake or the BLM’s designated rather than endangered due to responsible under the National ACEC near Borax Lake). Therefore, the substantial progress in conservation and Environmental Policy Act to analyze DOGAMI is required to accept recovery of the species. The State any proposed ROW project including comment, and consider protective criteria for recovery of Borax Lake chub the connected action (i.e., energy measures. This additional review is met due to (1) the protected development on private lands). through the DOGAMI process may ownership by TNC; (2) natural In 1983, the BLM designated 520 ac benefit the Borax Lake chub through the reproductive potential is not (210 ha) of public land surrounding addition of conservation measures endangered; (3) primary habitat is Borax Lake as an ACEC to protect Borax necessary to obtain a permit for protected; (4) habitat is protected from Lake chub and its habitat. In 2005, the geothermal exploration. commercial use; (5) public access is record of decision for the RMP for the restricted to foot traffic; (6) no harvest State of Oregon, Oregon Department of Andrews Resource Area added 80 ac (32 is allowed; (7) only infrequent scientific Energy’s Energy Facility Siting Council ha), for a total 600-ac (243-ha) Borax or educational use occurs; (8) most (EFSC) Lake ACEC (BLM 2005a, p. 70). surrounding land is protected from Off-road vehicle damage along the The EFSC has regulatory and siting geothermal development on Federal lake shoreline has been documented in responsibility for proposed generating lands; and (9) water rights of the lake the past (Scheerer and Jacobs 2005, p. 6; facilities greater than 35 megawatts in were obtained by the ODFW for the 2006, p. 7; 2007, p. 6; 2008, p. 6; 2009, Oregon. The OAR–345–022–0040 purpose of conserving Borax Lake chub. p. 8; 2010, p. 4; Scheerer and Bangs prohibits the EFSC from issuing site The Oregon ESA applies to actions of 2011, p. 9; Scheerer et al. 2012, p. 13; certificates for energy development in State agencies on State-owned or leased Scheerer et al. 2013, p. 6). As a result, protected areas such as BLM ACECs and land, and does not impose any in 2011, the BLM and TNC completed State natural heritage areas such as additional restrictions on the use of a perimeter fence surrounding the lake TNC’s Borax Lake Preserve. For private lands (ORS 496.192). The and most of the associated critical proposed energy developments in Oregon ESA is implemented by the habitat to exclude unauthorized unprotected areas, the EFSC applies State independently from the Federal vehicles, and in 2013, they installed Division 22 siting standards for fish and Endangered Species Act; thus, if locks on all access gates. Due to the wildlife habitat (OAR 345–022–0060), finalized, this proposed rule would not completion of the perimeter fence, the threatened and endangered species directly impact the current State listing threat to the Borax lake chub from (OAR 345–022–0070), and general of Borax Lake chub. Under the Oregon shoreline habitat alteration by vehicles standards of review (OAR 345–022– ESA, State agencies (other than State has been addressed. 000). Specific to Borax Lake chub, OAR land-owning or land-managing agencies) 345–022–0060 requires that a proposed State of Oregon, Department of Geology determine the role they may serve in facility comply with the habitat and Mineral Industries (DOGAMI) contributing toward conservation or mitigation goals and standards of the take avoidance (OAR 635–100–0150). In Oregon, Oregon Revised Statute ODFW as defined in OAR 635–415– The Oregon Endangered Species List is (ORS) chapter 522 authorizes DOGAMI 0025. The ODFW defines Borax Lake a nonregulatory tool that helps focus to control drilling, re-drilling, and chub habitat as a Habitat Category 1 wildlife management and research with deepening of wells for the discovery and under the habitat mitigation standard. the goal of preventing species from production of geothermal resources. The mitigation goal for Habitat Category declining to the point of extinction Under this authority, a developer 1 is no loss of either habitat quantity or (ORS 496.171, 496.172, 496.176, undertaking geothermal exploration on quality. The ODFW is required to 496.182, and 496.192). all land (public and private) must first protect habitats in Category 1 by Per OAR 635–415–0025 (Habitat obtain a permit from DOGAMI (Oregon recommending or requiring: (1) Mitigation Policy), the ODFW would Administrative Rule (OAR) 632–020– Avoidance of impacts through provide comments and 0028). DOGAMI process requires alternatives to the proposed recommendations on risks to all native circulation of any permit application to development action, or (2) no fish and wildlife from a proposed other State agencies that manage natural authorization of the proposed geothermal development project in the resources such as the Water Resources development action if impacts cannot be Alvord Basin through all State and Department, ODFW, Department of avoided. To issue a site certificate, the county permitting processes. If there Environmental Quality, State Parks and EFSC must find that the design, was any indication that a proposed Recreation Department, Department of construction, and operation of the geothermal development project would Land Conservation and Development, facility, taking into account mitigation, have a geothermal or groundwater Department of State Lands, and the are consistent with the fish and habitat connection with Borax Lake, the ODFW governing body of the county and mitigation goals and standards of OAR would recommend that alternatives be geothermal heating district in which the 635–415–0025 (OAR 345–022–0060 developed or that the action not be well will be located (ORS 522.125(1)). Fish and Wildlife Habitat). permitted (ODFW 2012, p. 9). Any of these agencies can suggest The ODFW filed for water rights at conditions under which a permit should State of Oregon, Oregon Department of Borax Lake in 1991, and that right is be granted or denied. DOGAMI is Fish and Wildlife now certified to the Oregon Water required to take State agency comments The Borax Lake chub was listed as Resources Department, to prevent into consideration when deciding to endangered in 1987, and then further attempts at diverting the water grant a permit (OAR 632–020–0170). As reclassified to threatened in 2017 under and to ensure maintenance of the water part of the conditions for geothermal the Oregon Endangered Species Act elevation in Borax Lake (see Delisting development on private land, a (Oregon ESA), which prohibits the Criterion 3 discussion, above). The

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purpose of the water right is to provide the Borax Lake chub from geothermal and their behavior deep underground. the required habitat conditions for the development, but they do reduce the The response of the species would Borax Lake chub. The right is likelihood of impact from development depend upon the specifics of any established under Oregon Revised on private lands in the vicinity of Borax geothermal energy development that Statute 537.341, with a priority date of Lake. might proceed to the implementation August 21, 1991. The right is limited to E. Other Natural or Manmade Factors phase (e.g., scale of the project and the amount of water necessary to Affecting Its Continued Existence proximity to Borax Lake). Depending on maintain a surface water elevation of the circumstances of any particular 4,081 ft (1,244 m) above mean sea level. The 1982 listing rule (47 FR 43957; project, such development could For purposes of water distribution, the October 5, 1982) did not identify any potentially have a negative effect on the other natural or human-made factors instream right shall not have priority species or it might have no or negligible affecting Borax Lake chub or its habitat. over human or livestock consumption. effects. The possibility of geothermal No threats have arisen under this threat The right has been recorded in the State development in the vicinity of Borax record of Water Right Certificates as factor since that time, and none is anticipated in the foreseeable future. Lake will continue to represent a 75919. potential threat to Borax Lake chub and Thus, the protections of the Oregon Potential impacts of climate change are its habitat, but we have determined the ESA, ODFW policy on geothermal addressed in this proposed rule under likelihood of this threat becoming development permitting, and the A. The Present or Threatened establishment of a dedicated water right Destruction, Modification, or operative in the foreseeable future is for conservation at Borax Lake provide Curtailment of Its Habitat or Range, low. for significant ongoing protection and above. An increase in ambient air allow for critical review of future Overall Summary of Factors Affecting temperatures due to climate change may development projects. the Borax Lake Chub reduce the amount and suitability of habitat for Borax Lake chub during the Summary of Factor D The primary factors that threatened warmest times of the year (June through Conservation ownership of Borax the Borax Lake chub at the time of August) due to water temperatures that Lake and surrounding lands by TNC listing (47 FR 43957; October 5, 1982) can meet or sometimes exceed thermal (320 ac; 129 ha), withdrawal of Borax were potential impacts from geothermal maximums for the species. However, Lake waters from appropriation, the energy development, diversion of the shallow-water thermal refuge habitats lake’s outflows by alteration of the mineral withdrawal within the Alvord around the margins of Borax Lake (the shoreline crust, and potential KGRA under the 2000 Steens Act, and overflow channel and wetland), cool development of a recreation facility. the mineral withdrawal and and cold water vents within the lake, management guidelines under the Most of these threats or potential threats along with the species’ ability to BLM’s ACEC around Borax Lake (600 have been removed or ameliorated by rebound quickly following periods of ac; 243 ha) provide significant implementing actions identified in the low population abundance, are expected regulatory protections to the Borax Lake Borax Lake Chub Recovery Plan (see the ecosystem that would remain discussion of downlisting criteria under to provide resilience against potential unchanged should this proposal to Recovery, above). Actions that have future effects of climate change to the delist the Borax Lake chub be finalized. been taken to reduce or eliminate the Borax Lake chub. While State and Federal regulatory destruction and modification of Borax Factor B (overutilization for mechanisms exist that would protect the Lake chub habitat (Factor A) include commercial, recreational, scientific, or Borax Lake ecosystem from potential acquisition of Borax Lake by TNC, the educational purposes), Factor C (disease effects of development of geothermal BLM’s designation of adjacent lands as and predation), and Factor E (other resources on 2,000 ac (809 ha) of private an ACEC, protection of subsurface and natural or manmade factors affecting its land in proximity to Borax Lake, these surface waters, protection from mineral continued existence) were not identified regulatory mechanisms do not guarantee withdrawal, and closure of fragile lands as threat factors in the listing of Borax a development proposal would not to livestock grazing and unauthorized Lake chub in 1982 (47 FR 43957; legally proceed to implementation. vehicle access. October 5, 1982), and these factors are However, these regulatory mechanisms Proposals to develop geothermal currently not known to be threats to the ensure State and Federal natural energy resources in the Borax Lake Borax Lake chub now or in the resource agencies will be made aware of vicinity have occurred sporadically over foreseeable future. any proposals moving forward for the last 4 decades, and for that reason, permitting (e.g., DOGAMI) and that it is reasonable to expect additional We conclude that existing regulatory comments by applicable State and proposals to develop geothermal energy mechanisms (Factor D) provide Federal resource agencies will be are likely in the foreseeable future. significant protections to Borax Lake considered. As noted previously, However, none of these proposals has chub and its habitat, especially on DOGAMI requires geothermal moved forward with implementation Federal lands, and address most of the developers to provide baseline over a 4-decade period, and this history reasons that the species was listed. No information to show there would be no leads us to conclude that the likelihood regulatory mechanisms are in place that connection to geothermal or of geothermal energy development in fully prevent geothermal development groundwater in areas of environmental the vicinity of Borax Lake in the on private lands in the vicinity of Borax concern (e.g., Borax Lake or the BLM’s foreseeable future is low. Furthermore, Lake. However, we determined that this designated ACEC near Borax Lake). while geothermal development in the potential threat is not likely to manifest Similarly, the EFSC requires that a vicinity of Borax Lake is considered a in the foreseeable future; therefore, no proposed facility comply with the potential threat to Borax Lake chub, the threats remain that require regulatory habitat mitigation goals and standards of precise effects of possible geothermal mechanisms to address them in the the ODFW as defined in OAR 635–415– development on the species are event that the species were delisted and 0025. These regulatory mechanisms do uncertain and unpredictable given the the protections of the Act were no not completely remove potential risk to unknown nature of geothermal fluids longer in place.

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Proposed Determination of Species (overutilization for commercial, portion. Therefore, for a particular Status recreational, scientific, or educational portion, if we determine that there is not purposes) and Factor C (disease or substantial information that one of these Introduction predation) are not threats to Borax Lake statements is true, then the species does Section 4 of the Act (16 U.S.C. 1533), chub. We conclude that under Factor D not warrant listing because of its status and its implementing regulations at 50 (the inadequacy of existing regulatory in that portion of its range. CFR part 424, set forth the procedures mechanisms), the existing regulatory We evaluated the range of the Borax for determining whether a species is an mechanisms provide significant Lake chub to determine if any area may endangered species or threatened protections to Borax Lake chub and its be a significant portion of the range. The species and should be included on the habitat, especially on Federal lands, but Borax Lake chub is a narrow endemic Federal Lists of Endangered and they do not address potential impacts of that occurs in Borax Lake in the Alvord Threatened Wildlife and Plants (listed). geothermal development on private Basin. The historical known natural The Act defines an endangered species lands. However, as discussed above, we range of the Borax Lake chub is limited as any species that is ‘‘in danger of have determined that the likelihood of to Borax Lake and associated outflows extinction throughout all or a significant the threat of geothermal development in and wetlands. Based on the small range portion of its range’’ and a threatened the vicinity of Borax Lake becoming of the Borax Lake chub, approximately species as any species ‘‘that is likely to operative in the foreseeable future is 10.2-ac (4.1-ha), we determined that the become an endangered species within low; therefore, no regulatory species is a single, contiguous the foreseeable future throughout all or mechanisms are needed to address this population and that there are no a significant portion of its range.’’ The potential threat. All of these threats separate areas of the range that are likely Act requires that we determine whether apply similarly throughout the range of to be of greater biological or a species meets the definition of the species in Borax Lake. conservation importance than any other ‘‘endangered species’’ or ‘‘threatened Thus, after assessing the best available areas due to natural biological reasons species’’ because of any of the following information, we conclude that the Borax alone. Therefore, there is not substantial factors: Lake chub is not currently in danger of information that logical, biological (A) The present or threatened extinction, and is not likely to become divisions exist that would support destruction, modification, or so within the foreseeable future delineating one or more portions within curtailment of its habitat or range; throughout all of its range. the species’ range. (B) Overutilization for commercial, Because we have determined that the Based on our determination that no recreational, scientific, or educational Borax Lake chub is not in danger of natural biological divisions are purposes; extinction or likely to become so in the delineating separate portions of the (C) Disease or predation; foreseeable future throughout all of its Borax Lake chub population, we (D) The inadequacy of existing range, we will consider whether there conclude that there are no portions of regulatory mechanisms; or are any significant portions of its range the species’ range for which both (1) the (E) Other natural or manmade factors in which the species is in danger of portions are likely to be significant and affecting its continued existence. extinction or likely to become so in the (2) the species is likely to be in danger Determination of Status Throughout All foreseeable future. of extinction or likely to become so in the foreseeable future in those portions. of the Species’ Range Determination of Status Throughout a This makes it unnecessary for us to Significant Portion of Its Range As required by section 4(a)(1) of the undertake any further consideration or Act, we conducted a review of the status Under the Act and our implementing analysis of whether this species is of the Borax Lake chub and assessed the regulations, a species may warrant endangered or threatened throughout an five factors to evaluate whether it is listing if it is in danger of extinction or SPR. We conclude therefore that there is endangered or threatened throughout all likely to become so in the foreseeable no significant portion of the species’ of its range. We examined the best future throughout all or a significant range where it is an endangered species scientific and commercial information portion of its range (SPR). Having or a threatened species. Our approach to available regarding the past, present, determined that the Borax Lake chub is analyzing SPR in this determination is and future threats faced by the species. not in danger of extinction now or likely consistent with the court’s holding in Significant threats identified at the time to become so in the foreseeable future Desert Survivors v. Department of the of listing (47 FR 43957; October 5, 1982) throughout all of its range, we now Interior, No. 16–cv–01165–JCS, 2018 have been eliminated or reduced. We consider whether it may be in danger of WL 4053447 (N.D. Cal. Aug. 24, 2018). conclude that under Factor A (the extinction or likely to become so in the Our review of the best available present or threatened destruction, foreseeable future in an SPR. The range scientific and commercial information modification, or curtailment of its of a species can theoretically be divided indicates that the Borax Lake chub is habitat or range), the possibility of into portions in an infinite number of not in danger of extinction nor likely to geothermal development in the vicinity ways, so we first screen the potential become endangered within the of Borax Lake will continue to represent portions of the species’ range to foreseeable future throughout all or a a potential threat to Borax Lake chub determine if there are any portions that significant portion of its range. and its habitat, but we have determined warrant further consideration. To do Therefore, we find that the Borax Lake the likelihood of this threat becoming this, we look for portions of the species’ chub does not meet the definition of a operative in the foreseeable future is range for which there is substantial threatened species, and we propose to low. We did not identify any other information indicating that: (1) The remove the Borax Lake chub from the threats from development on private portion may be significant, and (2) the List. lands in the vicinity of Borax Lake. We species may be in danger of extinction have identified climate change as a new or likely to become so in the foreseeable Effects of the Proposed Rule potential threat to Borax Lake chub, but future in that portion. A portion only This proposal, if made final, would the magnitude and frequency of this warrants further consideration if there is revise 50 CFR 17.11(h) by removing the potential threat is generally unknown at substantial information that both of Borax Lake chub from the Federal List this time. We conclude that Factor B these statements are true for that of Endangered and Threatened Wildlife.

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The prohibitions and conservation ODFW prior to delisting. Monitoring (c) Use clear language rather than measures provided by the Act, would consist of three components: jargon; particularly through sections 7 and 9, Borax Lake chub abundance, potential (d) Be divided into short sections and would no longer apply to this species. adverse changes to Borax Lake chub sentences; and Federal agencies would no longer be habitat due to environmental or (e) Use lists and tables wherever required to consult with the Service anthropogenic factors, and monitoring possible. under section 7 of the Act in the event DOGAMI for drilling applications. The If you feel that we have not met these that activities they authorize, fund, or PDM would consist of surveys to requirements, send us comments by one carry out may affect the Borax Lake estimate population abundance of the methods listed in ADDRESSES. To chub. Critical habitat for Borax Lake conducted once every 3 years over a better help us revise the rule, your chub at 50 CFR 17.95(e) would be 9-year period (four population surveys comments should be as specific as removed if this proposal is made final. total), which would begin after the final possible. For example, you should tell State laws related to Borax Lake chub delisting rule is published. Given the us the numbers of the sections or would remain in place, be enforced, and Borax Lake chub is a short lived fish paragraphs that are unclearly written, continue to provide protection for this (few survive beyond 1 year; Scoppettone which sections or sentences are too species. et al. 1995, p. 36), periodic monitoring long, the sections where you feel lists or tables would be useful, etc. Post-Delisting Monitoring over this time period would allow us to address any possible negative effects to National Environmental Policy Act Section 4(g)(1) of the Act requires the the Borax Lake chub. Additionally, the Secretary of the Interior, through the chub experienced wide fluctuation in its We have determined that Service and in cooperation with the population year-to-year. Limited data environmental assessments and States, to implement a system to points for a widely fluctuating environmental impact statements, as monitor for not less than 5 years for all population can lead to weak defined under the authority of the species that have been recovered and information. Therefore, we chose to National Environmental Policy Act of delisted. The purpose of this extend the time sequence to ensure we 1969 (42 U.S.C. 4321 et seq.), need not requirement is to develop a program can accurately measure changes in be prepared in connection with that detects the failure of any delisted trends. regulations pursuant to section 4(a) of species to sustain populations without The draft PDM plan identifies the Act. We published a notice outlining the protective measures provided by the measurable management thresholds and our reasons for this determination in the Act. If, at any time during the responses for detecting and reacting to Federal Register on October 25, 1983 monitoring period, data indicate that significant changes in the Borax Lake (48 FR 49244). protective status under the Act should chub’s protected habitat, distribution, be reinstated, we can initiate listing Government-to-Government and persistence. If declines are detected Relationship With Tribes procedures, including, if appropriate, equaling or exceeding these thresholds, emergency listing. In accordance with the President’s the Service, in combination with other A draft post-delisting monitoring memorandum of April 29, 1994, PDM participants, would investigate (PDM) plan has been developed for the Government-to-Government Relations causes of these declines, including Borax Lake chub, building on and with Native American Tribal considerations of habitat changes, continuing the research that was Governments (59 FR 22951), Executive substantial human persecution, conducted during the listing period. The Order 13175, and the Department of the stochastic events, or any other draft PDM plan will be peer reviewed by Interior’s manual at 512 DM 2, we significant evidence. The result of the specialists and will be available for readily acknowledge our responsibility investigation would be to determine if public comment upon the publication of to communicate meaningfully with the Borax Lake chub warrants expanded this proposed rule at http:// recognized Federal Tribes on a monitoring, additional research, www.regulations.gov, under docket government-to-government basis. In additional habitat protection, or number FWS–R1–ES–2017–0035. Public accordance with Secretarial Order 3206 relisting as an endangered or a and peer review comments submitted in of June 5, 1997 (American Indian Tribal threatened species under the Act. If response to the draft PDM plan will be Rights, Federal-Tribal Trust such monitoring data or an otherwise addressed within the body of the plan Responsibilities, and the Endangered updated assessment of threats (such as and summarized in an appendix to the Species Act), we readily acknowledge specific information on proposed plan. The draft PDM plan was our responsibilities to work directly geothermal development projects) developed by the Service and is based with Tribes in developing programs for indicate that relisting the Borax Lake on actions outlined in the CMP healthy ecosystems, to acknowledge that chub is warranted, emergency developed by the Service, BLM, and Tribal lands are not subject to the same procedures to relist the species may be ODFW. The draft PDM plan consists of: controls as Federal public lands, to followed, if necessary, in accordance (1) A summary of the species’ status at remain sensitive to Native American with section 4(b)(7) of the Act. the time of proposed delisting; (2) an culture, and to make information outline of the roles of PDM cooperators; Required Determinations available to Tribes. (3) a description of monitoring methods; We do not believe that any Tribes (4) an outline of the frequency and Clarity of This Proposed Rule would be affected if we adopt this rule duration of monitoring; (5) an outline of We are required by Executive Orders as proposed. However, we have data compilation and reporting 12866 and 12988 and by the contacted the Burns Paiute Tribe to procedures; and (6) a definition of Presidential Memorandum of June 1, coordinate with them regarding this thresholds or triggers for potential 1998, to write all rules in plain proposed rule. monitoring outcomes and conclusions language. This means that each rule we of the PDM. publish must: References Cited The draft PDM plan proposes to (a) Be logically organized; A complete list of all references cited monitor Borax Lake chub following the (b) Use the active voice to address in this proposed rule is available at same sampling protocol used by the readers directly; http://www.regulations.gov at Docket

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No. FWS–R1–ES–2017–0035 or upon Proposed Regulation Promulgation § 17.11 [Amended] request from the Oregon Fish and ■ 2. Amend § 17.11(h) by removing the Wildlife Office (see FOR FURTHER Accordingly, we hereby propose to entry for ‘‘Chub, Borax Lake’’ under INFORMATION CONTACT). amend part 17, subchapter B of chapter FISHES from the List of Endangered and I, title 50 of the Code of Federal Threatened Wildlife. Authors Regulations, as set forth below: § 17.95 [Amended] The primary authors of this proposed PART 17—ENDANGERED AND ■ 3. Amend § 17.95(e) by removing the rule are staff members of our Oregon THREATENED WILDLIFE AND PLANTS entry for ‘‘BORAX LAKE CHUB (Gila Fish and Wildlife Office. boraxobius).’’ ■ List of Subjects in 50 CFR Part 17 1. The authority citation for part 17 Dated: December 7, 2018. continues to read as follows: Margret E. Everson, Endangered and threatened species, Authority: 16 U.S.C. 1361–1407; 1531– Exports, Imports, Reporting and Principal Deputy Director, U.S. Fish and 1544; and 4201–4245, unless otherwise Wildlife Service, Exercising the Authority of recordkeeping requirements, noted. the Director, U.S. Fish and Wildlife Service. Transportation. [FR Doc. 2019–02979 Filed 2–25–19; 8:45 am] BILLING CODE 4333–15–P

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Notices Federal Register Vol. 84, No. 38

Tuesday, February 26, 2019

This section of the FEDERAL REGISTER potential persons who are to respond to development of new and additional contains documents other than rules or the collection of information that such markets, marketing facilities, and uses proposed rules that are applicable to the persons are not required to respond to for such commodities. public. Notices of hearings and investigations, the collection of information unless it Need and Use of the Information: The committee meetings, agency decisions and displays a currently valid OMB control information collection is needed to rulings, delegations of authority, filing of petitions and applications and agency number. provide assistance through the MFP with respect to commodities that have statements of organization and functions are Farm Service Agency examples of documents appearing in this been significantly impacted by actions section. Title: Biofuels Infrastructure of foreign governments resulting in the Partnership (BIP). loss of traditional exports. In order to OMB Control Number: 0560–0284. determine whether a producer is eligible DEPARTMENT OF AGRICULTURE Summary of Collection: The Farm for MFP and to calculate a payment, a Service Agency (FSA) announced the producer is required to submit the Submission for OMB Review; availability of competitive grants to following forms: CCC–901—MFP Comment Request fund States, the Commonwealth of Application, CCC–902—Farm Operating Puerto Rico, and Washington, DC with February 21, 2019. Plans for an Individuall, CCC–941— respect to activities designed to expand Average Adjusted Gross Income (AGI) The Department of Agriculture has the infrastructure for renewable fuels. submitted the following information Certification and Consent to Disclosure The goal is for grantees to provide funds of Tax Information, FSA 578—Report of collection requirement(s) to OMB for on a one-to-one basis to receive review and clearance under the Acreage, and AD–1026—Highly matching Commodity Credit Erodible Land Conservation (HELC) and Paperwork Reduction Act of 1995, Corporation (CCC) funds under the Public Law 104–13. Comments are Wetland Conservation Certification. authority in section 5Ö of CCC Charter Lack of adequate information to make required regarding (1) whether the Act (15 U.S.C. 714c(e)). This collection of information is necessary the determination could result in the information collection is needed for improper administration and for the proper performance of the FSA to identify eligible States for functions of the agency, including appropriation of CCC funds. blender pump funding to encourage Description of Respondents: Farms. whether the information will have increased ethanol use. FSA requires practical utility; (2) the accuracy of the Number of Respondents: 898,600. each State interested to apply for BIP Frequency of Responses: Reporting; agency’s estimate of burden including grant through www.grants.gov. the validity of the methodology and Other (one-time). Need and Use of the Information: FSA Total Burden Hours: 669,850. assumptions used; (3) ways to enhance will use the collected information to the quality, utility and clarity of the determine whether participants meet Ruth Brown, information to be collected; and (4) the eligibility requirements to be a Departmental Information Collection ways to minimize the burden of the recipient of grant funds. Lack of Clearance Officer. collection of information on those who adequate information to make the [FR Doc. 2019–03239 Filed 2–25–19; 8:45 am] are to respond, including through the determination could result in the BILLING CODE 3410–05–P use of appropriate automated, improper administration and electronic, mechanical, or other appropriation of Federal grants funds. technological collection techniques or Description of Respondents: State, COMMISSION ON CIVIL RIGHTS other forms of information technology. Local and Tribal Government. Comments regarding this information Number of Respondents: 19. Notice of Public Meeting of the New collection received by March 28, 2019 Frequency of Responses: Hampshire Advisory Committee will be considered. Written comments Recordkeeping; Reporting: Other (once). should be addressed to: Desk Officer for Total Burden Hours: 109. AGENCY: Commission on Civil Rights. Agriculture, Office of Information and ACTION: Announcement of meeting. Regulatory Affairs, Office of Farm Service Agency Management and Budget (OMB), New Title: Market Facilitation Program. SUMMARY: Notice is hereby given, Executive Office Building, 725 17th OMB Control Number: 0560–0292. pursuant to the provisions of the rules Street NW, Washington, DC 20502. Summary of Collection: This and regulations of the U.S. Commission Commenters are encouraged to submit information collection is required for on Civil Rights (Commission), and the their comments to OMB via email to: the Farm Service Agency (FSA) to make Federal Advisory Committee Act [email protected] or Market Facilitation Program (MFP) (FACA), thata meeting of the New fax (202) 395–5806 and to Departmental payments to domestic crop and Hampshire Advisory Committee to the Clearance Office, USDA, OCIO, Mail commodity producers. Specifically, the Commission will convene by conference Stop 7602, Washington, DC 20250– Commodity Credit Corporation (CCC) call at 3:00 p.m. (EST) on Thursday, 7602. Copies of the submission(s) may Charter Act (15 U.S.C. 714c) authorizes February 28, 2019. The purpose of the be obtained by calling (202) 720–8958. CCC to assist in the disposition of meeting is for project planning. An agency may not conduct or surplus commodities and to increase the DATES: Thursday, February 28, 2019, at sponsor a collection of information domestic consumption of agricultural 3:00 p.m. (EST). unless the collection of information commodities by expanding or aiding in Public Call-In Information: displays a currently valid OMB control the expansion of domestic markets or by Conference call-in number: 1–800–667– number and the agency informs developing or aiding in the 5617 and conference call 7737084.

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FOR FURTHER INFORMATION CONTACT: Agenda viral); dolutegravir/lamivudine tablets Evelyn Bohor, at [email protected] or by (anti-viral); Dovato tablets® (anti-viral); February 28, 2019, Thursday; 3:00 p.m. umeclidinium bromide/vilanterol phone at 202–376–7533. (EST) trifenatate ellipta (respiratory inhaler); SUPPLEMENTARY INFORMATION: Interested • Roll Call Anoro Ellipta® (respiratory inhaler); members of the public may listen to the • Project Planning umeclidinium bromide ellipta discussion by calling the following toll- • Open Comment (respiratory inhaler); Incruse Ellipta® free conference call-in number: 1–800– • Adjourn (respiratory inhaler); fluticasone 667–5617 and conference call 7737084. Dated: February 21, 2019. furoate/umeclidinium bromide/ Please be advised that before placing David Mussatt, vilanterol trifenatate ellipta (respiratory them into the conference call, the ® Supervisory Chief, Regional Programs Unit. inhaler); and, Trelegy Ellipta conference call operator will ask callers (respiratory inhaler). GlaxoSmithKline [FR Doc. 2019–03281 Filed 2–25–19; 8:45 am] to provide their names, their would be able to avoid duty on foreign- organizational affiliations (if any), and BILLING CODE P status components which become scrap/ email addresses (so that callers may be waste. Customs duties also could notified of future meetings). Callers can possibly be deferred or reduced on DEPARTMENT OF COMMERCE expect to incur charges for calls they foreign-status production equipment. initiate over wireless lines, and the Foreign-Trade Zones Board Public comment is invited from Commission will not refund any interested parties. Submissions shall be incurred charges. Callers will incur no [B–05–2019] addressed to the Board’s Executive charge for calls they initiate over land- Secretary at the address below. The Foreign-Trade Zone (FTZ) 93—Raleigh/ closing period for their receipt is April line connections to the toll-free Durham, North Carolina, Notification of conference call-in number. 8, 2019. Proposed Production Activity, A copy of the notification will be Persons with hearing impairments GlaxoSmithKline, PLC (Pharmaceutical available for public inspection at the may also follow the discussion by first Products), Zebulon, North Carolina Office of the Executive Secretary, calling the Federal Relay Service at 1– The Triangle J Council of Foreign-Trade Zones Board, Room 800–877–8339 and providing the Governments, grantee of FTZ 93, 21013, U.S. Department of Commerce, operator with the toll-free conference submitted a notification of proposed 1401 Constitution Avenue NW, call-in number: 1–800–667–5617 and production activity to the FTZ Board on Washington, DC 20230–0002, and in the conference call 7737084. behalf of GlaxoSmithKline, PLC ‘‘Reading Room’’ section of the Board’s Members of the public are invited to (GlaxoSmithKline), located in Zebulon, website, which is accessible via make statements during the open North Carolina. The notification www.trade.gov/ftz. comment period of the meeting or conforming to the requirements of the For further information, contact Diane submit written comments. The regulations of the FTZ Board (15 CFR Finver at [email protected] or comments must be received in the 400.22) was received on February 13, (202) 482–1367. regional office approximately 30 days 2019. Dated: February 19, 2019. after each scheduled meeting. Written GlaxoSmithKline already has Andrew McGilvray, comments may be mailed to the Eastern authority to produce certain Executive Secretary. Regional Office, U.S. Commission on pharmaceutical products within Site 6 [FR Doc. 2019–03236 Filed 2–25–19; 8:45 am] of FTZ 93. The current request would Civil Rights, 1331 Pennsylvania BILLING CODE 3510–DS–P Avenue, Suite 1150, Washington, DC add finished products and a foreign- 20425, faxed to (202) 376–7548, or status material/component to the scope of authority. Pursuant to 15 CFR emailed to Evelyn Bohor at ero@ DEPARTMENT OF COMMERCE 400.14(b), additional FTZ authority usccr.gov. Persons who desire would be limited to the specific foreign- Foreign-Trade Zones Board additional information may contact the status material/component (dolutegravir Eastern Regional Office at (202) 376– sodium) and specific finished products [B–57–2018] 7533. described in the submitted notification Foreign-Trade Zone (FTZ) 149— Records and documents discussed (as described below) and subsequently Freeport, Texas, Authorization of during the meeting will be available for authorized by the FTZ Board. Production Activity, DSM Nutritional public viewing as they become available Production under FTZ procedures Products, LLC (Vinylol), Freeport, at https://www.facadatabase.gov/FACA/ could exempt GlaxoSmithKline from Texas FACAPublicViewCommittee customs duty payments on the foreign- Details?id=a10t0000001gzlXAAQ; click status material/component used in On September 11, 2018, the Port of the ‘‘Meeting Details’’ and ‘‘Documents’’ export production. On its domestic Freeport, grantee of FTZ 149, submitted links. Records generated from this sales, for foreign-status dolutegravir a notification of proposed production meeting may also be inspected and sodium (duty rate, 6.5%) and foreign- activity to the FTZ Board on behalf of reproduced at the Eastern Regional status components in the existing scope DSM Nutritional Products, LLC, within Office, as they become available, both of authority, GlaxoSmithKline would be Subzone 149B, in Freeport, Texas. before and after the meetings. Persons able to choose the duty-free rate during The notification was processed in customs entry procedures that applies accordance with the regulations of the interested in the work of this advisory to: Dolutegravir sodium/rilpivirine HCl; FTZ Board (15 CFR part 400), including committee are advised to go to the Juluca tablets® (anti-viral); dolutegravir notice in the Federal Register inviting Commission’s website, www.usccr.gov, sodium tablets (anti-viral); Tivicay public comment (83 FR 47131, or to contact the Eastern Regional Office tablets® (anti-viral); abacavir sulfate/ September 18, 2018). On February 19, at the above phone numbers, email or dolutegravir sodium/lamivudine tablets 2019, the applicant was notified of the street address. (anti-viral); Triumeq tablets® (anti- FTZ Board’s decision that no further

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review of the activity is warranted at In accordance with the FTZ Board’s Staff is designated examiner to review this time. The production activity regulations, Elizabeth Whiteman of the the application and make described in the notification was FTZ Staff is designated examiner to recommendations to the Executive authorized, subject to the FTZ Act and review the application and make Secretary. the FTZ Board’s regulations, including recommendations to the Executive Public comment is invited from Section 400.14. Secretary. interested parties. Submissions shall be Public comment is invited from Dated: February 19, 2019. addressed to the Board’s Executive interested parties. Submissions shall be Secretary at the address below. The Andrew McGilvray, addressed to the FTZ Board’s Executive closing period for their receipt is April Executive Secretary. Secretary at the address below. The 8, 2019. Rebuttal comments in response [FR Doc. 2019–03238 Filed 2–25–19; 8:45 am] closing period for their receipt is April to material submitted during the BILLING CODE 3510–DS–P 8, 2019. Rebuttal comments in response foregoing period may be submitted to material submitted during the during the subsequent 15-day period to foregoing period may be submitted April 22, 2019. DEPARTMENT OF COMMERCE during the subsequent 15-day period to A copy of the application will be April 22, 2019. Foreign-Trade Zones Board available for public inspection at the A copy of the application will be Office of the Executive Secretary, [S–21–2019] available for public inspection at the Foreign-Trade Zones Board, Room Office of the Executive Secretary, 21013, U.S. Department of Commerce, Foreign-Trade Zone 40—Cleveland, Foreign-Trade Zones Board, Room 1401 Constitution Avenue NW, Ohio, Application for Subzone 21013, U.S. Department of Commerce, Washington, DC 20230–0002, and in the Expansion, Swagelok Company, 1401 Constitution Avenue NW, ‘‘Reading Room’’ section of the Board’s Ravenna, Ohio Washington, DC 20230–0002, and in the website, which is accessible via ‘‘Reading Room’’ section of the FTZ An application has been submitted to www.trade.gov/ftz. Board’s website, which is accessible via For further information, contact the Foreign-Trade Zones (FTZ) Board by www.trade.gov/ftz. the Cleveland Cuyahoga County Port Qahira El-Amin at Qahira.El-Amin@ For further information, contact trade.gov or (202) 482–5928. Authority, grantee of FTZ 40, requesting Elizabeth Whiteman at an expansion of Subzone 40I on behalf [email protected] or (202) Dated: February 19, 2019. of Swagelok Company (Swagelok). The 482–0473. Andrew McGilvray, application was submitted pursuant to Executive Secretary. the provisions of the Foreign-Trade Dated: February 19, 2019. Andrew McGilvray, [FR Doc. 2019–03237 Filed 2–25–19; 8:45 am] Zones Act, as amended (19 U.S.C. 81a– BILLING CODE 3510–DS–P 81u), and the regulations of the FTZ Executive Secretary. Board (15 CFR part 400). It was formally [FR Doc. 2019–03235 Filed 2–25–19; 8:45 am] docketed on February 19, 2019. BILLING CODE 3510–DS–P DEPARTMENT OF COMMERCE Subzone 40I currently consists of the following sites: Site 1 (70 acres) 29500 International Trade Administration Solon Rd & 29495 FA Lennon Dr., DEPARTMENT OF COMMERCE [A–583–856] Solon, Cuyahoga County; Site 2 (13.3 Foreign-Trade Zones Board acres) 31400 Aurora Rd., Solon, Corrosion-Resistant Steel Products Cuyahoga County; Site 3 (5 acres) 29500 [S–23–2019] From Taiwan: Notice of Court Decision Ambina Dr., Solon, Cuyahoga County; Not in Harmony With Final Foreign-Trade Zone 262—Southaven, Site 4 (7.82 acres) 26651 & 26653 Curtiss Determination of Antidumping Duty Mississippi; Application for Subzone; Wright Parkway, Willoughby Hills, Investigation and Notice of Amended WPG Americas Inc.; Southaven, Cuyahoga County; Site 5 (16.8 acres) Final Determination of Investigation 318,348, & 358 Bishop Rd., Highland Mississippi Heights, Cuyahoga County; Site 6 (23.95 An application has been submitted to AGENCY: Enforcement and Compliance, acres) 6050, 6060, & 6100 Cochran Rd., the Foreign-Trade Zones Board (the International Trade Administration, Solon, Cuyahoga County; Site 7 (3 acres) Board) by the Northern Mississippi FTZ, Department of Commerce. 29900 Solon Industrial Parkway, Solon, Inc., grantee of FTZ 262, requesting SUMMARY: On December 20, 2018, the Cuyahoga County; Site 8 (5 acres) 32550 subzone status for the facility of WPG United States Court of International Old South Miles Rd., Solon, Cuyahoga Americas Inc., located in Southaven, Trade (Court) issued a final judgment in County; and, Site 9 (9.5 acres) 15400 Mississippi. The application was Prosperity Tieh Enterprise Co., Ltd. et al. Foltz Parkway, Strongsville, Cuyahoga submitted pursuant to the provisions of v. United States, Consol. Court No. 16– County. the Foreign-Trade Zones Act, as 00138; Slip Op. 18–175 (CIT Dec. 20, The proposed expanded subzone amended (19 U.S.C. 81a–81u), and the 2018), sustaining the Department of would include the following additional regulations of the Board (15 CFR part Commerce’s (Commerce) remand results site: Site 10 (8.87 acres), 935 N Freedom 400). It was formally docketed on for the final determination of the St., Ravenna, Portage County. Because February 19, 2019. antidumping investigation of certain the proposed site is outside FTZ 40’s The proposed subzone (1.25 acres) is corrosion-resistant steel products Alternative Site Framework (ASF) located at 481 Airport Industrial Drive, (CORE) from Taiwan, covering the service area, authorization of the Suite 102, Southaven, Mississippi. No period of investigation (POI) April 1, expanded subzone would not be under authorization for production activity has 2014, through March 31, 2015. the ASF. No authorization for expanded been requested at this time. The Commerce is notifying the public that production activity has been requested proposed subzone would be subject to the Court has made a final judgment at this time. The proposed subzone the existing activation limit of FTZ 262. that is not in harmony with Commerce’s would be subject to the existing In accordance with the Board’s amended final determination of the activation limit of FTZ 40. regulations, Qahira El-Amin of the FTZ antidumping investigation, and that

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Commerce is amending the final Prosperity based on Commerce’s finding constitutes a final decision of the Court determination. that Prosperity misclassified certain of that is not in harmony with Commerce’s DATES: Applicable December 30, 2018. its products in reporting sales in the Final Determination and Amended databases by placing these products in Final Determination and Order. As FOR FURTHER INFORMATION CONTACT: the wrong yield strength category.5 The such, Commerce has published this Shanah Lee, AD/CVD Operations Office Court held that, in reporting its yield notice in fulfillment of the publication III, Enforcement and Compliance, strength, ‘‘Prosperity complied with the requirement of Timken. International Trade Administration, instructions as Commerce wrote U.S. Department of Commerce, 1401 them.’’ 6 The Court ruled that Amended Final Determination and Constitution Avenue NW, Washington, ‘‘Commerce may not use facts otherwise Amended Order DC 20230; telephone: (202) 482–6386. available as a substitute for information Because there is now a final court SUPPLEMENTARY INFORMATION: that is now on the administrative record decision, Commerce is amending the Background of the investigation, but indicated that Final Determination and Amended ‘‘the type of corrective action is a matter Final Determination and Order with On June 2, 2016, Commerce published for Commerce to decide’’ as to this respect to the weighted-average its Final Determination, and on July 25, remanded issue.7 dumping margin for the Yieh Phui/ 2016, Commerce published its In its Final Results Redetermination, Prosperity/Synn entity. Furthermore, in Amended Final Determination and Commerce: (1) Granted, under protest, the Amended Final Determination and Order concerning the antidumping downward price adjustments to the Order, and in accordance with section investigation of CORE from Taiwan.1 home market sales price equal to the 735(c)(5)(A) of the Act, for companies The plaintiffs in this litigation, amount of Yieh Phui’s post-sale rebates not individually investigated, we consisting of the two-mandatory granted to the company’s home market applied an ‘‘all-others’’ rate of 10.34 respondents, Prosperity Tieh Enterprise customers; (2) continued to treat percent.14 This rate was determined Co., Ltd. (Prosperity) and Yieh Phui Prosperity, Yieh Phui, and Synn as a based on assigning the Yieh Phui/ Enterprise Co., Ltd. (Yieh Phui) timely single-entity consistent with 19 CFR Prosperity/Synn entity’s rate as the all- filed complaints with the Court 351.401(f); and (3) revised, under others rate.15 As noted above, the Yieh challenging certain aspects of protest, the Yieh Phui/Prosperity/Synn Phui/Prosperity/Synn’s amended Commerce’s investigation. The entity’s weighted-average dumping weighted-average dumping margin is petitioners in the investigation, AK margin by using Prosperity’s reported now 3.66 percent. Therefore, for Steel Corporation, Nucor Corporation, yield strength data.8 After accounting purposes of this amended Final Steel Dynamics, Inc., California Steel for all such changes and issues in the Determination, Commerce will instruct Industries, Inc., ArcelorMittal USA LLC, Final Results Redetermination, the CBP that the all-others rate is to be and United States Steel Corporation resulting antidumping margin for the amended to 3.66 percent.16 intervened as defendant-intervenors. Yieh Phui/Prosperity/Synn entity is Accordingly, the revised weighted- On January 23, 2018, the Court 3.66 percent.9 On December 20, 2018, average dumping margin for the remanded three aspects of Commerce’s the Court sustained the Final Results collapsed Yieh Phui/Prosperity/Synn 2 findings, in Prosperity Tieh I. First, the Redetermination, in Prosperity II.10 entity and for all-others is as follows: Court held that Commerce’s Timken Notice determination to deny Yieh Phui’s and Weighted- Synn Industrial Co., Ltd.’s post-sale In its decision in Timken,11 as average rebate adjustments ‘‘violated its own clarified by Diamond Sawblades,12 the Producer dumping Court of Appeals for the Federal Circuit margin regulations,’’ and remanded to (percent) Commerce to ‘‘correct this error.’’ 3 (Federal Circuit) held that, pursuant to Second, the Court remanded section 516A of the Tariff Act of 1930, Prosperity Tieh Enterprise Co., Commerce’s determination to collapse as amended (Act), Commerce must Ltd., Yieh Phui Enterprise Co., Prosperity, Yieh Phui, and Synn publish a notice of a court decision that Ltd., and Synn Industrial Co., pursuant to its analysis under 19 CFR is not ‘‘in harmony’’ with a Commerce Ltd ...... 3.66 351.401(f), because ‘‘the collapsing determination and must suspend All-Others ...... 3.66 decision was based on erroneous liquidation of entries pending a findings of fact.’’ 4 Third, the Court ‘‘conclusive’’ court decision.13 The Cash Deposit Requirements remanded Commerce’s application of Court’s December 20, 2018, judgment Since the Final Determination, partial adverse facts available to Commerce has established a new cash 5 Id. at 20–31. 6 Id. at 28. deposit rate for Prosperity and Yieh 1 Certain Corrosion-Resistant Steel Products from 17 7 Phui/Synn. Therefore, this amended Taiwan: Final Determination of Sales at Less Than Id. at 30–31. Fair Value and Final Affirmative Determination of 8 See Final Results of Redetermination Pursuant final determination does not change the Critical Circumstances, in Part, 81 FR 35313 (June to Prosperity Tieh Enterprise Co., Ltd. et al. v. 2, 2016), and accompanying Issues and Decision United States, Consol. Court No. 16–00138; Slip. 14 See Amended Final Determination and Order, Memorandum (IDM) (Final Determination), as Op. 18–5, dated May 23, 2018 (Final Results 81 FR at 48391; Final Determination, 81 FR at amended by Certain Corrosion-Resistant Steel Redetermination). 35314. Products from India, Italy, the People’s Republic of 9 Id. at 31. 15 See Final Determination, 81 FR at 35314. China, the Republic of Korea and Taiwan: 10 See Prosperity Tieh Enterprise Co., Ltd. et al. 16 See United States Steel Corp. v. United States, Amended Final Affirmative Antidumping v. United States, Consol. Court No. 16–00138, Slip. Slip Op. 18–139, at 8 (CIT October 17, 2018). Determination for India and Taiwan, and Op. 18–175 (CIT December 20, 2018) (Prosperity II) 17 See Certain Corrosion-Resistant Steel Products Antidumping Duty Orders, 81 FR 48390 (July 25, (this opinion was made public on February 11, from Taiwan: Final Results of Antidumping 2016) (Amended Final Determination and Order). 2019). Administrative Review; 2016–2017, 83 FR 64527 2 See Prosperity Tieh Enterprise Co., Ltd. et al. v. 11 See Timken Co. v. United States, 893 F.2d 337 (December 17, 2018) (First Administrative Review United States, Consol. Court No. 16–00138; Slip (Fed. Cir. 1990) (Timken). Final Results). As a result of this administrative Op. 18–5, at 2, 31–32 (CIT January 23, 2018) 12 See Diamond Sawblades Mfrs. Coalition v. review, Commerce continued to treat Yieh Phui and (Prosperity Tieh I). United States, 626 F.3d 1374 (Fed. Cir. 2010) Synn as a single entity and determined that 3 Id. at 6–15. (Diamond Sawblades). Prosperity should no longer be collapsed with Yieh 4 Id. at 15–20. 13 See sections 516A(c) and (e) of the Act. Phui and Synn.

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later-established cash deposit rates for International Trade Administration, Assessment Rates those producers and/or exporters. For U.S. Department of Commerce, 1401 Pursuant to section 751(a)(2)(C) of the all-other producers and/or exporters, Constitution Avenue NW, Washington, Act, and 19 CFR 351.212(b)(1), except for companies that subsequently DC, 20230; telephone: (202) 482–4136. Commerce determined, and U.S. received their own rates in the first SUPPLEMENTARY INFORMATION: On 18 Customs and Border Protection (CBP) administrative review, Commerce will November 5, 2018, Commerce published shall assess, antidumping duties on all issue revised cash deposit instructions the Preliminary Results and invited appropriate entries of subject to U.S. Customs and Border Protection, 1 comments from interested parties. No merchandise in accordance with the adjusting the cash deposit rate for all- interested party submitted comments. final results of this review. Commerce other producers and/or exporters to 3.66 Commerce conducted this intends to issue appropriate assessment percent, effective December 30, 2018. administrative review in accordance Lastly, we note that, at this time, instructions directly to CBP 15 days with sections 751(a)(1) and (2) of the after publication of the final results of Commerce remains enjoined by Court Tariff Act of 1930, as amended (the Act). order from liquidating entries that were this administrative review. Commerce exercised its discretion to Because we calculated a zero margin produced and/or exported by Prosperity toll all deadlines affected by the partial and imported by Prosperity Tieh USA, for LGE in the final results of this federal government closure from review, we intend to instruct CBP to that were the subject of the First December 22, 2018, through the Administrative Review Final Results, liquidate without regard to antidumping resumption of operations on January 28, duties all shipments of subject and that were entered, or withdrawn 2 2019. If the new deadline falls on a merchandise manufactured and from warehouse, on or after June 2, non-business day, in accordance with exported by LGE, entered or withdrawn 2016, up to and including June 30, 2017. Commerce’s practice, the deadline will from warehouse, for consumption, These entries will remain enjoined become the next business day. The during the POR. In accordance with pursuant to the terms of the injunction revised deadline for the final results of Commerce’s ‘‘automatic assessment’’ during the pendency of any appeals this review is now April 15, 2019. process. practice, for entries of subject Scope of the Order merchandise during the POR produced Notification to Interested Parties The products covered by the order are by LGE for which it did not know that This notice is issued and published in all large residential washers and certain the merchandise was destined for the accordance with sections 516A(e), subassemblies thereof from Korea. The United States, we will instruct CBP to 751(a)(1), and 777(i)(1) of the Act. products are currently classifiable under liquidate those entries at the all-others Dated: February 19, 2019. subheadings 8450.20.0040 and rate if there is no rate for the intermediate company(ies) involved in Gary Taverman, 8450.20.0080 of the Harmonized Tariff the transaction.4 Deputy Assistant Secretary for Antidumping System of the United States (HTSUS). and Countervailing Duty Operations, Products subject to this order may also Cash Deposit Requirements performing the non-exclusive functions and enter under HTSUS subheadings duties of the Assistant Secretary for 8450.11.0040, 8450.11.0080, The following cash deposit Enforcement and Compliance. 8450.90.2000, and 8450.90.6000. requirements will be effective upon [FR Doc. 2019–03240 Filed 2–25–19; 8:45 am] Although the HTSUS subheadings are publication of the final results of this administrative review for all shipments BILLING CODE 3510–DS–P provided for convenience and customs purposes, the written description of the of the subject merchandise entered, or merchandise subject to this scope is withdrawn from warehouse, for DEPARTMENT OF COMMERCE dispositive.3 consumption on or after the publication date, as provided for by section International Trade Administration Changes Since the Preliminary Results 751(a)(2)(C) of the Act: (1) The cash deposit rate for merchandise produced [A–580–868] As no parties submitted comments on the Preliminary Results, we made no and/or exported by LGE will be zero; (2) Large Residential Washers From the changes in the final results of this for previously reviewed or investigated Republic of Korea: Final Results of review. companies not covered by this review, the cash deposit rate will continue to be Antidumping Duty Administrative Final Results of the Review Review; 2017–2018 the company-specific rate published for As a result of this review, Commerce the most recent period; (3) if the AGENCY: Enforcement and Compliance, determines that a weighted-average exporter is not a firm covered in this International Trade Administration, dumping margin of 0.00 percent exists review, a prior review, or the less-than- Department of Commerce. for LGE for the period February 1, 2017, fair-value (LTFV) investigation, but the SUMMARY: The Department of Commerce through January 31, 2018. manufacturer is, the cash deposit rate (Commerce) determines that LG will be the rate established for the most Electronics, Inc. (LGE), a producer/ 1 See Large Residential Washers From the recent period for the manufacturer of exporter of large residential washers Republic of Korea: Preliminary Results of the Antidumping Duty Administrative Review; 2017– the merchandise; and (4) the cash from the Republic of Korea (Korea), did 2018, 83 FR 55346 (November 5, 2018) (Preliminary deposit rate for all other manufacturers not make sales at prices below normal Results). or exporters will continue to be 11.80 value during the February 1, 2017, 2 See Memorandum, ‘‘Deadlines Affected by the percent, the all-others rate established through January 31, 2018, period of Partial Shutdown of the Federal Government,’’ in the LTFV investigation.5 These review (POR). dated January 28, 2019. All deadlines in this segment of the proceeding have been extended by DATES: Applicable February 26, 2019. 40 days. 4 See Antidumping and Countervailing Duty FOR FURTHER INFORMATION CONTACT: 3 For a full descripition of the scope of the order, Proceedings: Assessment of Antidumping Duties, 68 David Goldberger, AD/CVD Operations, see Memorandum, ‘‘Decision Memorandum for the FR 23954 (May 6, 2003) for a full discussion of this Preliminary Results of the 2017–2018 practice. Office II, Enforcement and Compliance, Administrative Review of the Antidumping Duty 5 See Large Residential Washers from Mexico and Order on Large Residential Washers from the the Republic of Korea: Antidumping Duty Orders, 18 Id., at 64528. Republic of Korea,’’ dated October 29, 2018. 78 FR 11148 (February 15, 2013).

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deposit requirements, when imposed, Bearing Technology (Suzhou) Co., Ltd. and parts thereof. The subject shall remain in effect until further (GGB) sold tapered roller bearings and merchandise is currently classifiable notice. parts thereof, finished and unfinished under Harmonized Tariff Schedule of (TRBs) from the People’s Republic of the United States (HTSUS) subheadings: Notification to Importers China (China) at less than normal value 8482.20.00, 8482.91.00.50, 8482.99.15, This notice also serves as a final (NV) during the period of review (POR), 8482.99.45, 8483.20.40, 8483.20.80, reminder to importers of their June 1, 2016, through May 31, 2017. 8483.30.80, 8483.90.20, 8483.90.30, responsibility under 19 CFR DATES: Applicable February 26, 2019. 8483.90.80, 8708.70.6060, 8708.99.2300, 351.402(f)(2) to file a certificate FOR FURTHER INFORMATION CONTACT: 8708.99.4850, 8708.99.6890, regarding the reimbursement of Andrew Medley or Alex Wood, AD/CVD 8708.99.8115, and 8708.99.8180. The antidumping duties prior to liquidation Operations, Office II, Enforcement and HTSUS subheadings are provided for of the relevant entries during this Compliance, International Trade convenience and customs purposes review period. Failure to comply with Administration, U.S. Department of only; the written description of the this requirement could result in the Commerce, 1401 Constitution Avenue scope of the order is dispositive.6 Secretary’s presumption that NW, Washington, DC 20230; telephone: Analysis of Comments Received reimbursement of antidumping duties (202) 482–4987 or (202) 482–1959, occurred and the subsequent assessment respectively. In the Issues and Decision of double antidumping duties. SUPPLEMENTARY INFORMATION: Memorandum, we addressed all issues Administrative Protective Order raised in parties’ case and rebuttal Background briefs. Appendix I to this notice This notice also serves as a reminder Commerce published the Preliminary provides a list of the issues raised by to parties subject to administrative Results on July 12, 2018.1 For events parties. The Issues and Decision protective order (APO) of their subsequent to the Preliminary Results, Memorandum is a public document and responsibility concerning the return or see Commerce’s Issues and Decision is on file electronically via Enforcement destruction of proprietary information Memorandum.2 On August 2, 2018, in and Compliance’s Antidumping and disclosed under APO in accordance accordance with section 751(a)(3)(A) of Countervailing Duty Centralized with 19 CFR 351.305(a)(3), which the Tariff Act of 1930, as amended (the Electronic Service System (ACCESS). continues to govern business Act), Commerce extended the deadline ACCESS is available to registered users proprietary information in this segment for issuing the final results until January at https://access.trade.gov and is of the proceeding. Timely written 8, 2019.3 Commerce exercised its available to all parties in the Central notification of the return/destruction of discretion to toll all deadlines affected Records Unit, room B8024 of the main APO materials or conversion to judicial by the partial Federal government Department of Commerce building. In protective order is hereby requested. closure from December 22, 2018, addition, a complete version of the Failure to comply with the regulations through the resumption of operations on Issues and Decision Memorandum can and terms of an APO is a violation, January 29, 2019.4 If the tolled deadline be accessed directly at http:// which is subject to sanction. falls on a non-business day, in enforcement.trade.gov/frn/index.html. Notification to Interested Parties accordance with Commerce’s practice, The signed Issues and Decision the deadline will become the next Memorandum and the electronic We are issuing and publishing this business day. The revised deadline for version of the Issues and Decision notice in accordance with sections the final results is now February 19, Memorandum are identical in content. 751(a)(1) and 777(i)(1) of the Act, and 19 2019. CFR 351.221(b)(5). Changes Since the Preliminary Results Scope of the Order Dated: February 13, 2019. Based on our review of the record and Gary Taverman, The merchandise covered by the comments received from interested 5 Deputy Assistant Secretary for Antidumping Order includes tapered roller bearings parties regarding our Preliminary and Countervailing Duty Operations, Results, we made certain revisions to performing the non-exclusive functions and 1 See Tapered Roller Bearings and Parts Thereof, the margin calculations for GGB,7 and to Finished and Unfinished, from the People’s duties of the Assistant Secretary for the rate assigned to the non-examined, Enforcement and Compliance. Republic of China: Preliminary Results and Intent to Rescind the Review in Part; 2016–2017, 83 FR separate rate respondents.8 [FR Doc. 2019–03309 Filed 2–25–19; 8:45 am] 32263 (July 12, 2018) (Preliminary Results) and BILLING CODE 3510–DS–P accompanying Preliminary Decision Memorandum Separate Rate Respondents (PDM). 2 See Memorandum, ‘‘Issues and Decision In the Preliminary Results, we Memorandum for the Antidumping Duty determined that GGB and six other DEPARTMENT OF COMMERCE Administrative Review: Tapered Roller Bearings companies demonstrated their eligibility and Parts Thereof, Finished and Unfinished, from International Trade Administration the People’s Republic of China; 2016–2017,’’ dated for separate rates. We received no concurrently with, and hereby adopted by, this comments or argument since the [A–570–601] notice (Issues and Decision Memorandum). issuance of the Preliminary Results that 3 See Memorandum, ‘‘Tapered Roller Bearings provide a basis for reconsideration of Tapered Roller Bearings and Parts and Parts Thereof, Finished and Unfinished, from these determinations. Therefore, for Thereof, Finished and Unfinished, the People’s Republic of China: Extension of Deadline for the Final Results of Antidumping Duty these final results, we continue to find From the People’s Republic of China: Administrative {Review},’’ dated October 16, 2018. that each of the companies listed in the Final Results of Antidumping Duty 4 See Memorandum, ‘‘Deadlines Affected by the Administrative Review; 2016–2017 Partial Shutdown of the Federal Government,’’ dated January 28, 2019. All deadlines in this 6 See Issues and Decision Memorandum for a AGENCY: Enforcement and Compliance, segment of the proceeding have been extended by complete description of the scope of the Order. International Trade Administration, 40 days. 7 See Memorandum ‘‘Calculations for GGB 5 See Notice of Antidumping Duty Order; Tapered Bearing Technology (Suzhou) Co., Ltd. for the Final Department of Commerce. Roller Bearings and Parts Thereof, Finished or Results,’’ dated concurrently with this notice. SUMMARY: The Department of Commerce Unfinished, From the People’s Republic of China, 8 See Issues and Decision Memorandum for a (Commerce) determines that GGB 52 FR 22667 (June 15, 1987) (Order). summary of these revisions.

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table in the ‘‘Final Results’’ section of calculating the rate for respondents not 92.84 percent and is not subject to this notice is eligible for a separate rate. individually examined in an change as a result of this review. Further, we determined in the administrative review. Section For companies subject to this review, Preliminary Results that each of 12 735(c)(5)(A) of the Act articulates a which established their eligibility for a companies failed to demonstrate an preference for not calculating an all- separate rate, Commerce determines that absence of de facto government control, others rate using rates which are zero, the following weighted-average and, thus, Commerce did not grant them de minimis, or based entirely on facts dumping margins exist for the period a separate rate.9 No party provided available.13 Accordingly, we generally June 1, 2015, through May 31, 2016: comments with respect to 10 of the 12 will determine the weighted-average companies, and, thus, we continue to dumping margin for companies not Weighted- find that those 10 companies listed are individually examined by weight average not eligible for separate rates.10 Further, Exporter dumping averaging the weighted-average margin we received comments from the dumping margins for the individually (percent) remaining two companies, Zhejiang examined respondents, excluding rates Machinery Import & Export Corp. that are zero, de minimis, or based GGB Bearing Technology (Zhejiang Machinery) and Zhejiang entirely on facts available.14 (Suzhou) Co., Ltd ...... 7.04 Zhaofeng Mechanical & Electronic Co., For the final results, we calculated a CNH Industrial Italia SpA ...... 7.04 Ltd. (Zhaofeng) with regards to their rate only for GGB. Therefore, for these GSP Automotive Group separate rate claims. We continue to Wenzhou Co. Ltd ...... 7.04 final results, following the practice Hangzhou Hanji Auto Parts find, based on record evidence, that described above, we have assigned to Zhejiang Machinery failed to Co., Ltd ...... 7.04 the companies that have not been Hangzhou Radical Energy-Sav- demonstrate an absence of de facto individually examined, but have ing Technology Co., Ltd ...... 7.04 government control; accordingly, we demonstrated their eligibility for a Ningbo Xinglun Bearings Import also are not granting a separate rate to separate rate, the weighted-average & Export Co., Ltd ...... 7.04 11 Zhejiang Machinery. With respect to dumping margin calculated for GGB. Zhejiang Sihe Machine Co., Ltd 7.04 Zhaofeng, we have further considered Zhejiang Zhaofeng Mechanical the information on the record and find Final Results of the Administrative & Electronic Co., Ltd ...... 7.04 that Zhaofeng has demonstrated the Review absence of de jure and de facto Because Zhejiang Machinery and 11 Assessment Rates government control, and thus, we are other companies did not demonstrate granting Zhaofeng a separate rate for Pursuant to section 751(a)(2)(C) of the that they are entitled to a separate rate, Act, and 19 CFR 351.212(b)(1), these final results.12 Commerce finds these 12 companies Finally, one additional company, Commerce has determined, and U.S. (listed in Appendix II of this notice) to Customs and Border Protection (CBP) Dingli, could not demonstrate that it 15 be part of the China-wide entity. shall assess, antidumping duties on all had a suspended entry during the POR. Because no party requested a review of In the Preliminary Results, we appropriate entries covered by this the China-wide entity, and Commerce review. Commerce intends to issue erroneously stated that we were no longer considers the China-wide rescinding the review with respect to assessment instructions to CBP 15 days entity as an exporter conditionally after the date of publication of these Dingli because it failed to provide 16 subject to administrative reviews, we final results of review. evidence of a suspended entry during did not conduct a review of the China- the POR. However, rather than rescind For GGB, we calculated importer- wide entity. The rate previously specific ad valorem duty assessment the review with respect to Dingli, we established for the China-wide entity is have determined that it is ineligible for rates based on the ratio of the total a separate rate, and thus is part of the amount of dumping calculated for the 13 See Ball Bearings and Parts Thereof from China-wide entity. France, Germany, Italy, Japan, and the United importer’s examined sales to the total entered value of those sales, in Rate for Non-Examined Separate-Rate Kingdom: Final Results of Antidumping Duty Administrative Reviews and Rescission of Reviews accordance with 19 CFR 351.212(b)(1). Respondents in Part, 73 FR 52823, 52824 (September 11, 2008), Where an importer-specific assessment The statute and our regulations do not and accompanying Issues and Decision Memorandum at Comment 16. rate is zero or de minimis, we will address the rate to be assigned to 14 See, e.g., Preliminary Determination of Sales at instruct CBP to liquidate the appropriate respondents not selected for individual Less Than Fair Value and Partial Affirmative entries without regard to antidumping examination when we limit our Determination of Critical Circumstances: Certain duties.17 examination of companies subject to the Polyester Staple Fiber from the People’s Republic of Pursuant to Commerce’s assessment administrative review pursuant to China, 71 FR 77373, 77377 (December 26, 2006), unchanged in Final Determination of Sales at Less practice, for entries that were not section 777A(c)(2)(B) of the Act. Than Fair Value and Partial Affirmative reported in the U.S. sales data submitted Generally, we look to section 735(c)(5) Determination of Critical Circumstances: Certain by GGB, we will instruct CBP to of the Act, which provides instructions Polyester Staple Fiber from the People’s Republic of China, 72 FR 19690 (April 19, 2007). liquidate such entries at the China-wide for calculating the all-others rate in an 18 15 rate. investigation, for guidance when In the Preliminary Results, we erroneously stated that we preliminarily were rescinding the For the respondents which were not review with respect to Dingli because it failed to selected for individual examination in 9 See Appendix II of this notice for a list of the provide evidence of a suspended entry during the 11 companies which Commerce continues to find POR. However, rather than rescind the review with this administrative review and which ineligible for a separate rate. Note that this list also respect to Dingli, we have determined that it is qualified for a separate rate, the includes a twelfth company, Hangzhou Xiaoshan ineligible for a separate rate. assessment rate will be equal to the Dingli Machinery Co., Ltd. (Dingli), which is 16 See Antidumping Proceedings: Announcement weighted-average dumping margin discussed further below. of Change in Department Practice for Respondent 10 Id. Selection in Antidumping Duty Proceedings and 11 For further discussion, see Comment 1 of the Conditional Review of the Nonmarket Economy 17 See 19 CFR 351.106(c)(2). accompanying Issues and Decision Memorandum. Entity (NME) in NME Antidumping Duty 18 See Non-Market Economy Antidumping 12 For further discussion, see Comment 2 of the Proceedings, 78 FR 65963, 65970 (November 4, Proceedings: Assessment of Antidumping Duties, 76 accompanying Issues and Decision Memorandum. 2013). FR 65694 (October 24, 2011).

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determined for GGB in the final results Notifications to Interested Parties DEPARTMENT OF COMMERCE of this administrative review. This notice serves as the only National Institute of Standards and For the companies identified in reminder to parties subject to Technology Appendix II as part of the China-wide administrative protective order (APO) of entity, because Commerce determined their responsibility concerning the that these companies did not qualify for Proposed Information Collection; disposition of proprietary information Comment Request; National Institute a separate rate, we will instruct CBP to disclosed under APO in accordance assess dumping duties on the of Standards and Technology (NIST), with 19 CFR 351.305(a)(3). Timely companies’ entries of subject Generic Clearance for Community written notification of return or merchandise at the rate of 92.84 percent. Resilience Data Collections destruction of APO materials, or Cash Deposit Requirements conversion to judicial protective order, AGENCY: National Institute of Standards The following cash deposit is hereby requested. Failure to comply and Technology, Commerce. requirements will be effective upon with the regulations and the terms of an ACTION: Notice. APO is a sanctionable violation. publication of the final results of this SUMMARY: The Department of administrative review for all shipments We are issuing and publishing these results of review in accordance with Commerce, as part of its continuing of the subject merchandise entered, or effort to reduce paperwork and withdrawn from warehouse, for sections 751(a)(1) and 777(i)(1) of the Act. respondent burden, invites the general consumption on or after the publication public and other Federal agencies to date, as provided for by section Dated: February 19, 2019. take this opportunity to comment on 751(a)(2)(C) of the Act: (1) For the Gary Taverman, proposed and/or continuing information exporters listed above, the cash deposit Deputy Assistant Secretary for Antidumping collections, as required by the rate will be equal to the weighted- and Countervailing Duty Operations, Paperwork Reduction Act of 1995. average dumping margin established in performing the non-exclusive functions and DATES: Written comments must be the final results of this review; (2) for duties of the Assistant Secretary for submitted on or before April 29, 2019. previously investigated or reviewed Enforcement and Compliance. ADDRESSES: Direct all written comments China and non-China exporters not Appendix I listed above that currently have a to Jennifer Jessup, Departmental separate rate, the cash deposit rate will List of Topics Discussed in the Issues and Paperwork Clearance Officer, Decision Memorandum continue to be the exporter-specific rate Department of Commerce, Room 6616, published for the most recently Summary 1401 Constitution Avenue NW, completed segment of this proceeding Background Washington, DC 20230 (or via the Scope of the Order where the exporter received that internet at [email protected]). Changes Since the Preliminary Results FOR FURTHER INFORMATION CONTACT: separate rate; (3) for all China exporters Discussion of the Issues of subject merchandise that have not 1. Zhejiang Machinery’s Separate Rate Requests for additional information or been found to be entitled to a separate Status copies of the information collection rate, the cash deposit rate will be the 2. Zhaofeng’s Separate Rate Status instrument and instructions should be rate for the China-wide entity, 92.84 3. Irrecoverable Value Added Taxes directed to Jennifer Helgeson, percent; and (4) for all non-China 4. Alleged Ministerial Error Economist, NIST, 100 Bureau Drive, MS exporters of subject merchandise which 5. GGB’s ‘‘Supplier Quality Issue’’ Parts 8603, Gaithersburg, MD 20899–1710, 6. TRB Parts from GGB’s Suppliers have not received their own separate telephone 301–975–6133, or via email to 7. Rollers from GGB’s Suppliers [email protected]. rate, the cash deposit rate will be the 8. Surrogate Values for Steel Plate rate applicable to the China exporter 9. Surrogate Values for Packing Materials SUPPLEMENTARY INFORMATION: that supplied that non-China exporter. 10. Surrogate Financial Ratios I. Abstract These deposit requirements, when Conclusion Through acts such as the National imposed, shall remain in effect until Appendix II further notice. Construction Safety Team Act (NCSTA) Companies Not Eligible for a Separate Rate and the NIST Organic Act, among Disclosure and To Be Treated as Part of the China-Wide others, as well as the President’s We intend to disclose the calculations Entity Climate Action Plan (2013), NIST performed to parties in this proceeding Company conducts research and develops guidance and other related tools to within five days of the date of 1. Apex Maritime Shanghai Co., Ltd. publication of this notice, in accordance 2. Crossroads Global Trading Co., Ltd. promote and enhance the safety and with 19 CFR 351.224(b). 3. Hangzhou Xiaoshan Dingli Machinery Co., well-being of people in the face of a hazard event. With this in mind, NIST Notifications to Importers Ltd. 4. Honour Lane Shipping Ltd. proposes to conduct a number of data This notice also serves as a final 5. Kinetsu World Express China Co., Ltd. collection efforts within the topic areas reminder to importers of their 6. Luoyang Bearing Corporation (Group) of disaster and failure studies and responsibility under 19 CFR 351.402(f) 7. Pacific Link Intl Freight Forwarding Co., community resilience and to file a certificate regarding the Ltd. sustainability, including studies of reimbursement of antidumping duties 8. Shanghai Dizhao Industrial Trading Co., specific disaster events (e.g., wildfire, prior to liquidation of the relevant Ltd. 9. Thi Group Shanghai Ltd. urban fire, structure collapse, hurricane, entries during this review period. 10. Weifang Haoxin-Conmet Mechanical earthquake, tornado, and flood events), Failure to comply with this requirement Products Co., Ltd. assessments of community resilience could result in the Secretary’s 11. Yantai Huilong Machinery Parts Co., Ltd. and sustainability, and evaluations of presumption that reimbursement of 12. Zhejiang Machinery Import & Export the usability and utility of NIST antidumping duties occurred and the Corp. guidance or other products. subsequent assessment of double [FR Doc. 2019–03308 Filed 2–25–19; 8:45 am] These data collection efforts may be antidumping duties. BILLING CODE 3510–DS–P either qualitative or quantitative in

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nature or may consist of mixed method used. The possible response Number of Respondents: 14,691 methods. Additionally, data may be time to complete a questionnaire may be responses per year. collected via a variety of means, 15 minutes or 2 hours to participate in Average Hours Per Response: The including but not limited to electronic an interview. USPTO estimates that it will take the or social media, direct or indirect Estimated Total Annual Burden public approximately between 20 observation (i.e., in person, video and Hours: 15,000. minutes (0.33 hours) and seventy-five audio collections), interviews, Estimated Total Annual Cost to minutes (1.25 hours) to complete the questionnaires, and focus groups. NIST Public: $0. information in this collection. This will limit its inquiries to data includes the time to gather the IV. Request for Comments collections that solicit strictly voluntary necessary information, prepare the opinions or responses. The results of the NIST invites comments on: (a) forms or documents, and submit the data collected will be used to decrease Whether the proposed collection of completed request to the USPTO. negative impacts of disasters on society, information is necessary for the proper Burden Hours: 4878.97 hours per and, in turn, increase community performance of the functions of the year. resilience within the U.S. communities. agency, including whether the Cost Burden: $12,182,379.50 per year. Steps will be taken to ensure anonymity information will have practical utility; Needs and Uses: of respondents in each activity covered (b) the accuracy of the agency’s estimate by this request. of the burden (including hours and cost) The public uses this collection to This notice pertains to both a revision of the proposed collection of submit applications for international and an extension of a previously information; (c) ways to enhance the registration and related requests to the approved submission. The NIST quality, utility, and clarity of the USPTO under the Madrid Protocol. The Engineering Laboratory utilizes this information to be collected; and (d) information in this collection is a matter clearance to conduct research in support ways to minimize the burden of the of public record and is used by the of topic areas of disaster and failure collection of information on public for a variety of private business studies, community resilience respondents, including through the use purposes related to establishing and (including studies of specific disaster of automated collection techniques or enforcing international trademark rights. events such as wildfire, urban fire, other forms of information technology. The information is available at USPTO structure collapse, hurricane, Comments submitted in response to facilities and is also accessible through earthquake, tornado, and flood events). this notice will be summarized and/or the USPTO website. This type of research is directly included in the request for OMB Frequency: On occasion. related to a range of disasters which are approval of this information collection; Respondent’s Obligation: Mandatory unpredictable in their number during a they also will become a matter of public to Obtain or Retain Benefits given year. Additionally, some disasters record. OMB Desk Officer: Nicholas A. Fraser, may require multiple studies resulting email: [email protected] in multiple collections. Therefore, in Sheleen Dumas, Once submitted, the request will be preparation of the upcoming disaster Departmental Lead PRA Officer, Office of the publicly available in electronic format season, NIST is requesting to increase Chief Information Officer, Commerce through www.reginfo.gov. Follow the the ICR Annual Response allotment Department. instructions to view Department of from 15,000 to 20,000 Responses; and [FR Doc. 2019–03243 Filed 2–25–19; 8:45 am] Commerce collections currently under the ICR Annual Hours allotment from BILLING CODE 3510–13–P review by OMB. 12,000 to 15,000. NIST assures that no changes will be made to any the Further information can be obtained individual information collection DEPARTMENT OF COMMERCE by: requests that have been approved for • Email: InformationCollection@ United States Patent and Trademark use. uspto.gov. Include ‘‘0651–00## Office information request’’ in the subject line II. Method of Collection of the message. Submission for OMB Review; • NIST will collect this information by Comment Request; ‘‘Madrid Protocol’’ Mail: Marcie Lovett, Records and electronic means when possible, as well Information Governance Branch Chief, as by mail, fax, telephone, technical The United States Patent and Office of the Chief Technology Officer, discussions, and in-person interviews. Trademark Office (USPTO) will submit United States Patent and Trademark NIST may also utilize observational to the Office of Management and Budget Office, P.O. Box 1450, Alexandria, VA techniques to collect this information. (OMB) for clearance the following 22313–1450. III. Data proposal for collection of information Written comments and under the provisions of the 1995 recommendations for the proposed OMB Control Number: 0693–0078. Paperwork Reduction Act. information collection should be sent on Form Number(s): None. Agency: United States Patent and or before March 28, 2019 to Nicholas A. Type of Review: Revision. Trademark Office, Commerce. Fraser, OMB Desk Officer, via email to Affected Public: Individuals or Title: Madrid Protocol. [email protected], or by households; first responders; businesses OMB Control Number: 0651–0051. fax to 202–395–5167, marked to the or other for-profit organizations; not-for- Form Number(s): attention of Nicholas A. Fraser. profit institutions; State, local or tribal • government; Federal government; PTO–1663 Marcie Lovett, • Standards-making bodies; Universities. PTO–1683 Chief, Records and Information Governance Estimated Number of Respondents: • PTO–2132 Branch, Office of the Chief Administrative 20,000. • PTO–2133 Officer, USPTO. Estimated Time per Response: Varied, • TEAS Global Form [FR Doc. 2019–03224 Filed 2–25–19; 8:45 am] dependent upon the data collection Type of Request: Regular. BILLING CODE 3510–16–P

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DEPARTMENT OF COMMERCE request’’ in the subject line of the Comments submitted in response to message. this notice may be made available to the United States Patent and Trademark • Mail: Marcie Lovett, Chief, Records public through regulations.gov. For this Office and Information Governance Branch, reason, please do not include in your Office of the Chief Administrative comments information of a confidential Submission for OMB Review; Officer, United States Patent and nature, such as sensitive personal Comment Request; Practitioner Trademark Office, P.O. Box 1450, information or proprietary information. Conduct and Discipline Alexandria, VA 22313–1450. If you send an email comment, your The United States Patent and Written comments and email address will be automatically Trademark Office (USPTO) will submit recommendations for the proposed captured and included as part of the to the Office of Management and Budget information collection should be sent on comment that is placed in the public (OMB) for clearance the following or before March 28, 2019 to Nicholas A. docket and made available on the Fraser, OMB Desk Officer, via email to internet. Please note that responses to proposal for collection of information _ _ under the provisions of the Paperwork Nicholas A. [email protected], or by this public comment request containing Reduction Act. fax to 202–395–5167, marked to the any routine notice about the Agency: United States Patent and attention of Nicholas A. Fraser. confidentiality of the communication will be treated as public comment that Trademark Office, Commerce. Marcie Lovett, Title: Practitioner Conduct and may be made available to the public, Chief, Records and Information Governance notwithstanding the inclusion of the Discipline. Branch, Office of the Chief Administrative OMB Control Number: 0651–0017. Officer, USPTO. routine notice. Form Number(s): ;No forms [FR Doc. 2019–03223 Filed 2–25–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: associated. BILLING CODE 3510–16–P Sarah Yue, 202–606–6894, or by email Type of Request: Regular. at [email protected]. Number of Respondents: 11,145. SUPPLEMENTARY INFORMATION: Average Hours Per Response: The CORPORATION FOR NATIONAL AND Title of Collection: Grantee Progress USPTO estimates that it will take the COMMUNITY SERVICE Report (GPR) Data Collection. public between 1 and 20 hours, OMB Control Number: [3045–0175]. depending upon the complexity of the Agency Information Collection Type of Review: Renewal. situation, to gather the necessary Activities; Submission to the Office of Respondents/Affected Public: information, prepare, and submit the Management and Budget for Review Businesses and Organizations; State, requirements in this collection. and Approval; Comment Request; Local or Tribal Governments. Burden Hours: 12,465 hours annually. Application Package for Grantee Total Estimated Number of Annual Cost Burden: $1,630.80. Progress Report (GPR) Data Collection Responses: 300 total respondents for Needs and Uses: This information is AmeriCorps State and National. 52 required by 35 U.S.C. 2, 32, and 33 and AGENCY: Corporation for National and respondents each for Commission administered by the USPTO through 37 Community Service (CNCS). Support Grants and Commission CFR 11.101–11.901 and 37 CFR 11.19– ACTION: Notice of information collection; Investment Funds. 20 respondents for 11.61. The information is used by the request for comment. Volunteer Generation Fund. Director of the Office of Enrollment and Total Estimated Number of Annual Discipline (OED) to investigate and, SUMMARY: In accordance with the Burden Hours: 4,540. where appropriate, prosecute Paperwork Reduction Act of 1995, Abstract: CNCS uses information practitioners for violations of the CNCS is proposing to renew an collected via the Grantee Progress USPTO Rules of Professional Conduct. information collection. Reports to assess grantee progress Registered practitioners are required to DATES: Written comments must be toward meeting approved objectives; to maintain proper documentation so that submitted to the individual and office identify areas of challenge and they can fully cooperate with an listed in the ADDRESSES section by April opportunity; to guide the allocation of investigation in the event of a report of 29, 2019. training and technical assistance an alleged violation. There are no forms ADDRESSES: You may submit comments, resources; and to compile portfolio-wide associated with this collection of identified by the title of the information data to report to external stakeholders. information. collection activity, by any of the CNCS seeks to continue using the Affected Public: Individuals or following methods: currently approved information households; businesses or other for- (1) By mail sent to: Corporation for collection until the revised information profits; and not-for-profit institutions. National and Community Service, collection is approved by OMB. The Frequency: On occasion. Attention Sarah Yue, 250 E Street SW, currently approved information Respondent’s Obligation: Required to Washington, DC, 20525. collection is due to expire on April 30, Obtain or Retain Benefits. (2) By hand delivery or by courier to 2020. OMB Desk Officer: Nicholas A. Fraser, the CNCS mailroom at the mail address Comments submitted in response to email: Nicholas_A._ given in paragraph (1) above, between this notice will be summarized and/or [email protected]. Once submitted, 9:00 a.m. and 4:00 p.m. Eastern Time, included in the request for OMB the request will be publicly available in Monday through Friday, except federal approval. Comments are invited on: (a) electronic format through reginfo.gov. holidays. Whether the collection of information is Follow the instructions to view (3) Electronically through necessary for the proper performance of Department of Commerce collections www.regulations.gov. the functions of the agency, including currently under review by OMB. Individuals who use a whether the information shall have Further information may be requested telecommunications device for the deaf practical utility; (b) the accuracy of the by: (TTY–TDD) may call 1–800–833–3722 agency’s estimate of the burden of the • Email: InformationCollection@ between 8:00 a.m. and 8:00 p.m. Eastern collection of information; (c) ways to uspto.gov. Include ‘‘0651–0017 copy Time, Monday through Friday. enhance the quality, utility, and clarity

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of the information to be collected; (d) normal business hours Monday through Purpose and Need for Action: The ways to minimize the burden of the Friday, from 8:00 a.m. to 4:30 p.m. purpose of the Proposed Action is to collection of information on (EST) or by email: ira.silverberg@ provide the Defense Distribution Depot, respondents, including through the use dla.mil. San Joaquin with a safe and secure ACP of automated collection techniques or at the Main Gate for light vehicles (e.g., other forms of information technology; SUPPLEMENTARY INFORMATION: DLA standard dual-axle trucks and cars), and (e) estimates of capital or start-up completed an EA to address the bicycles, and pedestrians that is costs and costs of operation, potential environmental consequences compliant with DoD Unified Facilities maintenance, and purchase of services associated with the Proposed Action. Criteria (UFC) 4–022–01, Security to provide information. Burden means This Finding of No Significant Impact Engineering: Entry Control Facilities/ the total time, effort, or financial (FONSI) incorporates the EA by Access Control Points, and UFC 4–010– resources expended by persons to reference, summarizes the results of the 01, DoD Minimum Antiterrorism generate, maintain, retain, disclose or analyses in the EA, and documents Standards for Buildings, under all force- provide information to or for a Federal DLA’s decision to upgrade the Main protection conditions. The Proposed agency. This includes the time needed Gate ACP at Defense Distribution Depot, Action would also provide adequate to review instructions; to develop, San Joaquin and surrounding area. DLA space on installation property for acquire, install and utilize technology has determined that the Proposed vehicle queuing entering the ACP, so and systems for the purpose of Action is not a major federal action that that queuing does not occur on collecting, validating and verifying significantly affects the quality of the Chrisman Road. The Proposed Action is information, processing and human environment within the context needed because the existing 58-year-old maintaining information, and disclosing of NEPA, and that no significant Main Gate ACP does not meet current and providing information; to train impacts on the human environment are DoD UFC requirements. Additionally, personnel and to be able to respond to associated with this decision. the Proposed Action is needed to reduce a collection of information, to search DLA consulted with the California existing queuing issues along Chrisman data sources, to complete and review State Historic Preservation Officer Road during high-volume employee the collection of information; and to (SHPO) at the California Department of shift changes. transmit or otherwise disclose the Parks and Recreation, Office of Historic Proposed Action and Alternatives: information. All written comments will Preservation, and the Buena Vista Under the Proposed Action, DLA would be available for public inspection on Rancheria of Me-Wuk Indians, Ione demolish and remove existing buildings regulations.gov. Band of Miwok Indians, North Valley and infrastructure within the proposed Dated: January 30, 2019. Yokuts Tribe, Southern Sierra Miwuk ACP footprint; construct a new, Sarah Yue, Nation, Wilton Rancheria, and United permanent ACP at the Main Gate on the Auburn Indian Community of the Senior Program and Project Specialist, installation; and implement off- AmeriCorps State and National. Auburn Rancheria for this Proposed installation road improvements. The Action. The SHPO concurred that the proposed ACP would consist of a visitor [FR Doc. 2019–03273 Filed 2–25–19; 8:45 am] Proposed Action would not affect BILLING CODE 6050–28–P center, identification check point, historic properties. The Buena Vista vehicle inspection area, gatehouse, Rancheria of Me-Wuk Indians provided overwatch building, active and passive a response indicating the Tribe was not DEPARTMENT OF DEFENSE vehicle barriers and security fencing, aware of any cultural resources, but utilities, and ancillary components. The Office of the Secretary requested notification if any issues arise existing Main Gate ACP, a warehouse, during the Proposed Action and if roadways and other pavements would [Docket ID DOD–2018–OS–0042] undeveloped soil would be disturbed. be demolished; two fabric tent DLA did not receive responses to the Notice of Availability for Finding of No structures would be relocated; and consultation requests with the other infrastructure (i.e., utilities, fencing, and Significant Impact for the tribes. The SHPO and tribal consultation Environmental Assessment asphalt pavement) would be removed documents and the responses from the and replaced. The Proposed Action Addressing Upgrade of the Main Gate SHPO and the Buena Vista Rancheria of Access Control Point at Defense would also require the installation of a Me-Wuk Indians are in Appendix A of traffic signal at the intersection of Distribution Depot, San Joaquin, the revised EA. California, and Surrounding Area Chrisman and Valpico Road, and the On July 12, 2018, a Federal Register restriping of one lane of Chrisman Road AGENCY: Defense Logistics Agency NOA was published announcing the leading to the intersection. After (DLA), Department of Defense (DoD). availability of the EA for a 30-day public completion of construction, the ACTION: Notice of availability (NOA). comment period that ended August 13, proposed ACP would operate as a 2018. One comment letter, from the San secondary ACP (i.e., an ACP that SUMMARY: This NOA documents DLA’s Joaquin County Department of Public operates during regular hours, but less decision to proceed with the proposed Works, was received during the EA than 24 hours per day), similar to the action to upgrade the Main Gate Access public comment period. The San existing Main Gate ACP. Light vehicles Control Point at Defense Distribution Joaquin County Department of Public would continue to have access to the Depot, San Joaquin California, and Works had no comments, but requested installation via the Truck Gate, which is Surrounding Area following the to be included on the distribution list currently open and would remain open completion of an Environmental for future project documents. The 24 hours per day, during the hours the Assessment (EA). The EA was prepared comment letter was added to Appendix proposed ACP is closed. Gate 2 and the as required under the National A of the revised EA. The revised EA is Employee Gate, which are currently Environmental Policy Act (NEPA) of available electronically at the Federal used under limited circumstances, 1969. eRulemaking Portal at http:// would be permanently closed. No new FOR FURTHER INFORMATION CONTACT: Ira www.regulations.gov within Docket ID: DLA personnel would be required to Silverberg at 571–767–0705 during DOD–2018–OS–0042. operate the proposed ACP.

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Description of the No Action NEPA. Therefore, an environmental recommendations to the Secretary of Alternative: Under the No Action impact statement for the Proposed Defense regarding: i. Which countries Alternative, DLA would not upgrade the Action is not required. are not emphasized in other U.S. study Main Gate ACP at Defense Distribution Dated: February 20, 2019. abroad programs, such as countries in Depot, San Joaquin. The ACP Shelly E. Finke, which few U.S. students are studying enhancements would not be provided, Alternate OSD Federal Register Liaison and countries which are of importance and operational conditions would not Officer, Department of Defense. to the national security interests of the be improved. Gate 2 and the Employee [FR Doc. 2019–03208 Filed 2–25–19; 8:45 am] United States, and are, therefore, critical Gate would remain open. Compliance countries for the purpose of 50 U.S.C. BILLING CODE 5001–06–P with DoD UFCs 4–010–01 and 4–022–01 1902(a)(1)(A); ii. which areas within the would not be met. Critical logistic and disciplines described in 50 U.S.C. security operations at Defense DEPARTMENT OF DEFENSE 1902(a)(1)(B) relating to the national Distribution Depot, San Joaquin would security interests of the United States be vulnerable to disruption and Office of the Secretary are areas of study in which U.S. potentially long-term denial of service, students are deficient in learning and which could have an immediate impact Charter Renewal of Department of are, therefore, critical areas within those on the command and control of these Defense Federal Advisory Committees disciplines for the purposes of that operations. DLA police would continue AGENCY: Department of Defense. section; iii. which areas within the to use inadequate facilities to inspect disciplines described in 50 U.S.C. incoming light vehicles. The No Action ACTION: Renewal of federal advisory committee. 1902(a)(1)(C) are areas in which U.S. Alternative would not meet the purpose students, educators, and Government of and need for the Proposed Action. SUMMARY: The Department of Defense is employees are deficient in learning and Potential Environmental Impacts: No publishing this notice to announce that in which insubstantial numbers of U.S. significant effects on environmental it is renewing the charter for the institutions of higher education provide resources would be expected from the National Security Education Board (‘‘the training and are, therefore, critical areas Proposed Action. Insignificant adverse Board’’). within those disciplines for the purpose effects on noise, air quality, geological FOR FURTHER INFORMATION CONTACT: Jim of that section; iv. how students desiring resources, water resources, biological Freeman, Advisory Committee scholarships or fellowships can be resources, health and safety, Management Officer for the Department infrastructure and transportation, and encouraged to work for an agency or of Defense, 703–692–5952. hazardous materials and wastes would office of the Federal Government be expected. Insignificant beneficial SUPPLEMENTARY INFORMATION: The involved in national security affairs or effects on geological resources, water Board’s charter is being renewed national security policy upon resources, health and safety, pursuant to 50 U.S.C. 1903(a) and in completion of their education; and v. infrastructure and transportation, and accordance with the Federal Advisory which foreign languages are critical to hazardous materials and wastes would Committee Act (FACA) of 1972 (5 the national security interests of the be expected. No impacts on land use or U.S.C., App) and 41 CFR 102–3.50(a). United States for purposes of 50 U.S.C. environmental justice would be The Board’s charter and contact 1902(a)(1)(D) (relating to grants for the expected. Details of the environmental information for the Board’s Designated National Flagship Language Initiative) consequences are discussed in the EA, Federal Officer (DFO) can be found at and 50 U.S.C. 1902(a)(1)(E) (relating to which is hereby incorporated by https://www.facadatabase.gov/FACA/ the scholarship program for advanced reference. apex/FACAPublicAgencyNavigation. English language studies by heritage Determination: DLA has determined The Board, pursuant to 50 U.S.C. community citizens). e. Encourage that implementation of the Proposed 1903(d) and, shall perform the following applications for fellowships under 50 Action will not have a significant effect functions: a. Develop criteria for U.S.C. Ch. 37 from graduate students on the human environment. Human awarding scholarships, fellowships, and having an educational background in environment was interpreted grants under 50 U.S.C. Ch. 37, including any academic discipline, particularly in comprehensively to include the natural an order of priority in such awards that the areas of science or technology. f. and physical environment and the favors individuals expressing an interest Provide the Secretary of Defense relationship of people with that in national security issues or pursuing biennially with a list of scholarship environment. Specifically, no highly a career in national security positions. b. recipients and fellowship recipients, uncertain or controversial impacts, Provide for wide dissemination of including an assessment of their foreign unique or unknown risks, or information regarding the activities area and language skills, who are cumulatively significant effects were assisted under 50 U.S.C. Ch. 37. c. available to work in a national security identified. Implementation of the Establish qualifications for students position. g. Not later than 30 days after Proposed Action will not violate any desiring scholarships or fellowships, a scholarship or fellowship recipient federal, state, or local laws. Based on the and institutions of higher education completes the study or education for results of the analyses performed during desiring grants, under 50 U.S.C. Ch. 37, which assistance was provided under preparation of the EA and consideration including, in the case of students the Program, provide the Secretary of of comments received during the public desiring a scholarship or fellowship, a Defense with a report fully describing comment period, Mr. Gordon B. Hackett requirement that the student have a the foreign area and language skills III, Director, DLA Installation demonstrated commitment to the study obtained by the recipient as a result of Management, concludes that of the discipline for which the the assistance. h. Review the implementation of the Proposed Action scholarship or fellowship is to be administration of the Program required at Defense Distribution Depot, San awarded. d. After taking into account under 50 U.S.C. Ch. 37. i. To the extent Joaquin does not constitute a major the annual analyses of trends in provided by the Secretary of Defense, federal action that would significantly language, international, area, and oversee and coordinate the activities of affect the quality of the human counter-proliferations studies under 50 the national Language Service Corps environment within the context of U.S.C. 1906(b)(1), make (‘‘the Corps’’) under 50 U.S.C. 1913,

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including: i. Assessing on a periodic perform the function of the Chair of the Committee Act (FACA) (5 U.S.C., App.), basis whether the Corps is addressing Board while the USD(P&R) is the Government in the Sunshine Act the needs identified by the head of unavailable. The authority to chair the (‘‘the Sunshine Act’’) (5 U.S.C. 552b), departments and agencies of the Federal Board may not be further delegated. and the General Services Government for personnel with skills in Pursuant to 50 U.S.C. 1903(c), Administration’s Federal Advisory various foreign languages; ii. individuals appointed by the President Committee Management; Final Rule Recommending plans for the Corps to shall receive no compensation for (‘‘the FACA Final Rule’’). (41 CFR 101– address foreign language shortfalls and service on the Board. All members shall 6 and 102–3). requirements of the departments and receive reimbursement of official Board- Purpose of the Meeting: To obtain, agencies of the Federal Government; iii. related travel and per diem. review, and evaluate classified Recommending effective ways to The public or interested organizations information related to the DPB’s mission increase public awareness of the need may submit written statements to the to advise on (a) issues central to for foreign languages skills and career Board membership about the Board’s strategic DoD planning; (b) policy paths in the Federal Government that mission and functions. Written implications of U.S. force structure and use those skills; and, iv. Overseeing the statements may be submitted at any force modernization and on DoD’s Corps efforts to work with Executive time or in response to the stated agenda ability to execute U.S. defense strategy; agencies and State and local of planned meeting of the Board. All (c) U.S. regional defense policies; and governments to respond to interagency written statements shall be submitted to (d) other research and analysis of topics plans and agreements to address overall the DFO for the Board, and this raised by the Secretary of Defense, the foreign language shortfalls and to utilize individual will ensure that the written Deputy Secretary of Defense, or the personnel to address the various types statements are provided to the Under Secretary of Defense for Policy. of crises that warrant foreign language membership for their consideration. Agenda: On March 13th and 14th, the skills. DPB will have Secret level or higher Dated: February 13, 2019. The Secretary of Defense, pursuant to discussions on national security issues 50 U.S.C. 1906, shall submit to the Shelly Finke, regarding 5G Technology. On March President and to the Congressional Alternate OSD Federal Register, Liaison 13th, Topics and speakers include (1) intelligence committees an annual Officer, Department of Defense. 5G Telecommunications from a National report of the conduct of the Program [FR Doc. 2019–03227 Filed 2–25–19; 8:45 am] Security Perspective, Kristen Baldwin required by 50 U.S.C. Ch. 37. During BILLING CODE 5001–06–P (Department of Defense) and Jeffrey preparation of this annual report, the Baum (Department of Defense); (2) Secretary of Defense shall consult with Intelligence Community Threat, the members of the Board, who shall DEPARTMENT OF DEFENSE Raymond Gabany (National Security each submit to the Secretary an Agency); (3) Spectrum, Standards, Office of the Secretary assessment of their hiring needs in the Supply Chain, and Technology areas of language and area studies and Defense Policy Board; Notice of Leadership, Honorable Dana Deasy projection of the deficiencies in such Federal Advisory Committee Meeting (Department of Defense) and Earl areas. The Secretary shall include all Comstock (Department of Commerce); assessments in the annual report. AGENCY: Under Secretary of Defense for (4) Warfighter Perspectives, General Pursuant to 50 U.S.C. 1903(b), the Policy, Defense Policy Board, Paul Nakasone (Department of Defense) Board shall be composed of the Department of Defense. and Lt General Bradford Shwedo following 15 individuals or the ACTION: Notice of federal advisory (Department of Defense) (5); 5G Industry representative of such individuals: i. committee meeting. Panel, Nate Tibbets (Qualcomm), Andre The Secretary of Defense, who shall Fuetsch (AT&T) and Chandra McMahon serve as the Chair of the Board. ii. The SUMMARY: The Department of Defense (Verizon); Government to Industry Secretary of Education. iii. The (DoD) is publishing this notice to Partnering, Mr. David Redl (Department Secretary of State. iv. The Secretary of announce that the following Federal of Commerce) and Ajit Pai (Federal Commerce. v. The Secretary of Advisory Committee meeting of the Communications Commission). On Homeland Security. vi. The Secretary of Defense Policy Board (DPB) will take March 14th the DPB will deliberate and Energy. vii. The Director of National place. report out to the John Rood, Under Intelligence. viii. The Chair of the DATES: Secretary of Defense for Policy. National Endowment for the Day 1—Closed to the public Meeting Accessibility: Pursuant to the Humanities. ix. Six individuals Wednesday, March 13, 2019 from 8:00 Sunshine Act, the FACA, and the FACA appointed by the President, who shall a.m. to 5:00 p.m. Final Rule (41 CFR 101–6), the DoD has be experts in the fields of international, Day 2—Closed to the public Thursday, determined that this meeting shall be language, area, and counter-proliferation March 14, 2019 from 8:00 a.m. to closed to the public. The Under studies education and who shall be 12:00 p.m. Secretary of Defense (Policy), in experts in the fields of international, consultation with the DoD FACA ADDRESSES: language, area, and counter-proliferation The closed meeting will be Attorney, has determined in writing that studies education who may not be held at The Pentagon, 2000 Defense this meeting be closed to the public officers or employees of the Federal Pentagon, Washington, DC 20301–2000. because the discussions fall under the Government. FOR FURTHER INFORMATION CONTACT: purview of Section 552b(c)(1) of the Consistent with 50 U.S.C. 1903, the Marcus Bonds, (703) 571–0854 (Voice), Sunshine Act and are so inextricably Secretary of Defense designates the 703–697–8606 (Facsimile), intertwined with unclassified material Under Secretary of Defense for [email protected] (Email). that they cannot reasonably be Personnel and Readiness (USD(P&R)) as Mailing address is 2000 Defense segregated into separate discussions the Chair of the Board. If the USD(P&R) Pentagon, Washington, DC 20301–2000. without disclosing secret or higher is unavailable to chair a specific session SUPPLEMENTARY INFORMATION: This classified material. of the Board, then the Assistant meeting is being held under the Committee’s Designated Federal Secretary of Defense for Readiness shall provisions of the Federal Advisory Officer or Point of Contact: Marcus

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Bonds, osd.pentagon.ousd- DEPARTMENT OF ENERGY and consultation pursuant to section [email protected]. 106 of the National Historic Federal Energy Regulatory Written Statements: Pursuant to 41 Preservation Act. Commission CFR 102–3.105(j) and 102–3.140(c) and m. Green Mountain filed a Pre- section 10(a)(3) of the FACA, the public [Project No. 2445–027] Application Document (PAD; including a proposed process plan and schedule) or interested organizations may submit with the Commission, pursuant to 18 written statements to the membership of Notice of Intent To File License Application, Filing of Pre-Application CFR 5.6 of the Commission’s the DPB at any time regarding its Document, and Approving Use of the regulations. mission or in response to the stated Traditional Licensing Process: Green n. A copy of the PAD is available for agenda of a planned meeting. Written Mountain Power Corporation review at the Commission in the Public statements should be submitted to the Reference Room or may be viewed on DPB’s Designated Federal Officer (DFO), a. Type of Filing: Notice of Intent to the Commission’s website (http:// which is listed in this notice or can be File License Application and Request to www.ferc.gov), using the eLibrary link. obtained from the GSA’s FACA Use the Traditional Licensing Process. Enter the docket number, excluding the Database—http:// b. Project No.: 2445–027. last three digits in the docket number www.facadatabase.gov/. Written c. Date Filed: December 21, 2018. field to access the document. For d. Submitted By: Green Mountain statements that do not pertain to a assistance, contact FERC Online Power Corporation (Green Mountain). scheduled meeting of the DPB may be Support at FERConlineSupport@ e. Name of Project: Center Rutland submitted at any time. However, if ferc.gov, (866) 208–3676 (toll free), or Project. individual comments pertain to a f. Location: On Otter Creek in the (202) 502–8659 (TTY). A copy is also specific topic being discussed at a Town of Rutland, Rutland County, available for inspection and planned meeting, then these statements Vermont. No federal lands are occupied reproduction at 2152 Post Road, must be submitted no later than five by the project works or located within Rutland, VT 05701. business days prior to the meeting in the project boundary. o. The licensee states its unequivocal question. The DFO will review all g. Filed Pursuant to: 18 CFR 5.3 and intent to submit an application for a submitted written statements and 5.5 of the Commission’s regulations. subsequent license for Project No. 2445. provide copies to all members. h. Potential Applicant Contact: Jason Pursuant to 18 CFR 16.20, each application for a subsequent license and Dated: February 21, 2019. Lisai, Director of Generation Operations, Green Mountain Power Corporation, 163 any competing license applications Shelly E. Finke, Acorn Lane, Colchester, VT 05446; (802) must be filed with the Commission at Alternate OSD Federal Register Liaison 655–8723; email at Jason.Lisai@ least 24 months prior to the expiration Officer, Department of Defense. greenmountainpower.com. of the existing license. All applications [FR Doc. 2019–03287 Filed 2–25–19; 8:45 am] i. FERC Contact: John Baummer at for license for this project must be filed BILLING CODE 5001–06–P (202) 502–6837; or email at by December 31, 2021. [email protected]. p. Register online at http:// j. Green Mountain filed its request to www.ferc.gov/docs-filing/ use the Traditional Licensing Process on esubscription.asp to be notified via DEPARTMENT OF ENERGY December 21, 2018, and provided public email of new filings and issuances notice of the request on December 20, related to this or other pending projects. Federal Energy Regulatory 2018. In a letter dated February 19, For assistance, contact FERC Online Commission 2019, the Director of the Division of Support. Hydropower Licensing approved Green Dated: February 19, 2019. [Docket Nos. IS18–766–000; IS18–767–000] Mountain’s request to use the Kimberly D. Bose, Traditional Licensing Process. Secretary. Mid-America Pipeline Company, LLC, k. With this notice, we are initiating [FR Doc. 2019–03265 Filed 2–25–19; 8:45 am] Seminole Pipeline Company LLC; informal consultation with the U.S. Fish BILLING CODE 6717–01–P Notice Rescheduling Technical and Wildlife Service and NOAA Conference Fisheries under section 7 of the Endangered Species Act and the joint DEPARTMENT OF ENERGY The technical conference that has agency regulations thereunder at 50 CFR been rescheduled for February 20, 2019, part 402; and NOAA Fisheries under Federal Energy Regulatory is hereby postponed due to the forecast section 305(b) of the Magnuson-Stevens Commission Fishery Conservation and Management of inclement weather. Information [Project No. 2685–029] regarding the new date for this Act and implementing regulations at 50 conference will be forthcoming in CFR 600.920. We are also initiating New York Power Authority; Notice of subsequent notice.1 consultation with the Vermont State Availability of Final Environmental Historic Preservation Officer, as Assessment Dated: February 19, 2019. required by section 106 of the National Kimberly D. Bose, Historic Preservation Act, and the In accordance with the National Secretary. implementing regulations of the Environmental Policy Act of 1969 and [FR Doc. 2019–03261 Filed 2–25–19; 8:45 am] Advisory Council on Historic the Federal Energy Regulatory BILLING CODE 6717–01–P Preservation at 36 CFR 800.2. Commission’s (Commission) l. With this notice, we are designating regulations, 18 CFR part 380, the Office Green Mountain as the Commission’s of Energy Projects has reviewed the 1 See the Notice of Technical Conference issued non-federal representative for carrying application for a new license for the on December 12, 2018, for additional details out informal consultation pursuant to Blenheim-Gilboa Pumped Storage regarding this conference. section 7 of the Endangered Species Act; Project, located on Schoharie Creek, in

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the Towns of Blenheim and Gilboa in Dated: February 19, 2019. 208–3676 (toll free), or (202) 502–8659 Schoharie County, New York, and has Kimberly D. Bose, (TTY). In lieu of electronic filing, please prepared a final Environmental Secretary. send a paper copy to: Secretary, Federal Assessment (EA) for the project. [FR Doc. 2019–03275 Filed 2–25–19; 8:45 am] Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The final EA contains Commission BILLING CODE 6717–01–P staff’s analysis of the potential The first page of any filing should environmental effects of the project, and include docket number P–6916–011. k. Description of Request: City and concludes that relicensing the project, DEPARTMENT OF ENERGY County of Denver proposes to upgrade with appropriate environmental Federal Energy Regulatory its turbine generator unit, which would protective measures, would not Commission increase the total installed capacity of constitute a major federal action that the project to 1.25–MW, and to convert [Project No. 6916–011] would significantly affect the quality of its license to an exemption. Denver the human environment. Notice of Application Accepted for Water is also proposing to construct a A copy of the final EA is available for Filing, Soliciting Motions To Intervene new switchyard adjacent to the review at the Commission in the Public and Protests, Ready for Environmental powerhouse, and to adjust the existing Reference Room, or may be viewed on Analysis, and Soliciting Comments, project boundary to include the primary the Commission’s website at http:// Recommendations, and Terms and power line. During construction, the www.ferc.gov, using the eLibrary link. Conditions: City and County of Denver, project would continue to operate Enter the docket number, excluding the Colorado normally, without any changes to the last three digits in the docket number surface area, surface elevation, or field, to access the document. For Take notice that the following existing impoundment. The assistance, contact FERC Online hydroelectric application has been filed construction activities are expected to Support at FERCOnlineSupport@ with the Commission and is available take approximately three years to ferc.gov, (866) 208–3676 (toll free), or for public inspection: complete. (202) 502–8659 (TTY). a. Application Type: Application for l. Locations of the Application: This You may also register online at http:// Non-capacity Amendment and filing may be viewed on the www.ferc.gov/docs-filing/ Conversion of License to an Exemption Commission’s website at http:// esubscription.asp to be notified via of Small Hydroelectric Power Project www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number P–6916 in the email of new filings and issuances from Licensing. docket number field to access the related to this or other pending projects. b. Project No: P–6916–011. c. Date Filed: January 4, 2019. documents. You may also register For assistance, contact FERC Online d. Applicant: City and County of online at http://www.ferc.gov/docs- Support. Denver, Colorado (Denver Water). filing/esubscription.asp to be notified For further information, contact Andy e. Name of Project: Strontia Springs via email of new filings and issuances Bernick at (202) 502–8660. Hydroelectric Project. related to this or other pending projects. Dated: February 14, 2019. f. Location: The project is located on For assistance, call 1–866–208–3676 or the South Platte River, in Douglas and Kimberly D. Bose, email [email protected], for Jefferson Counties, Colorado. TTY, call (202) 502–8659. A copy is also Secretary. g. Filed Pursuant to: Federal Power available for inspection and [FR Doc. 2019–03259 Filed 2–25–19; 8:45 am] Act, 16 U.S.C. 791(a)–825(r). reproduction at the address in item (h) BILLING CODE 6717–01–P h. Applicant Contact: Brian Gogas, above and at the Commission’s Public Denver Water, 1600 West 12th Avenue, Reference Room, located at 888 First Denver, Colorado 80204, (303) 628– Street NE, Room 2A, Washington, DC DEPARTMENT OF ENERGY 6000. 20426, or by calling (202) 502–8371. i. FERC Contact: Zeena Aljibury, (202) m. Individuals desiring to be included Federal Energy Regulatory 502–6065, [email protected]. on the Commission’s mailing list should Commission j. Deadline for filing comments, so indicate by writing to the Secretary motions to intervene, and protests: 60 of the Commission. [Project No. 8417–004] days from the issuance date of this n. Comments, Protests, or Motions to notice by the Commission; reply Intervene: Anyone may submit Sparhawk, LLC; Notice of Comment comments are due 105 days from the comments, a protest, or a motion to Period Extension issuance date of this notice by the intervene in accordance with the Commission. requirements of Rules of Practice and On November 27, 2018, the The Commission strongly encourages Procedure, 18 CFR 385.210, .211, .214, Commission issued a notice setting electronic filing. Please file motions to respectively. In determining the December 27, 2019, as the end of the intervene, protests, comments, or appropriate action to take, the formal period to file comments, motions recommendations using the Commission will consider all protests or to intervene, and protests on the Commission’s eFiling system at http:// other comments filed, but only those surrender application for the Old www.ferc.gov/docs-filing/efiling.asp. who file a motion to intervene in Sparhawk Mill Hydroelectric Project Commenters can submit brief comments accordance with the Commission’s No. 8417. The document published in up to 6,000 characters, without prior Rules may become a party to the the Federal Register on December 3, registration, using the eComment system proceeding. Any comments, protests, or 2018, at 83 FR 62317. Due to the at http://www.ferc.gov/docs-filing/ motions to intervene must be received funding lapse at certain federal agencies ecomment.asp. You must include your on or before the specified comment date between December 22, 2018 and January name and contact information at the end for the particular application. 25, 2019, the Commission is extending of your comments. For assistance, o. Filing and Service of Responsive the comment period until March 26, please contact FERC Online Support at Documents: Any filing must (1) bear in 2019. [email protected], (866) all capital letters the title COMMENTS,

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PROTEST, or MOTION TO INTERVENE of settlement. Likewise, as non- I. General Information as applicable; (2) set forth in the decisional staff, pursuant to 18 CFR A. Does this action apply to me? heading the name of the applicant and 385.2201 (2018), they are prohibited the project number of the application to from communicating with advisory staff This action is directed to the public which the filing responds; (3) furnish concerning any deliberations in this in general. This action may, however, be the name, address, and telephone docket. of interest to all who manufacture, number of the person protesting or Exceptions to this designation as non- process, or distribute industrial intervening; and (4) otherwise comply decisional are: chemicals. Since other entities may also with the requirements of 18 CFR Reudi Abersold be interested, the Agency has not attempted to describe all the specific 385.2001 through 385.2005. All Demetra Anas entities that may be affected by this comments, motions to intervene, or Jeffrey Fang action. protests must set forth their evidentiary Martin Lawera basis and otherwise comply with the Lisa Owings B. How can I get copies of this document requirements of 18 CFR 4.34(b). All Eric Primosch and other related information? comments, motions to intervene, or Felice Richter protests should relate to project works The docket for this action, identified Derek Shiau by docket identification (ID) number which are the subject of the license Nicholas Stavlas amendment. Agencies may obtain EPA–HQ–OPPT–2003–0004, is available Andrew Tamayo at http://www.regulations.gov or at the copies of the application directly from David Zlotnick the applicant. A copy of any protest or Office of Pollution Prevention and motion to intervene must be served Dated: February 19, 2019. Toxics Docket (OPPT Docket), upon each representative of the Kimberly D. Bose, Environmental Protection Agency applicant specified in the particular Secretary. Docket Center (EPA/DC), West William application. If an intervener files [FR Doc. 2019–03258 Filed 2–25–19; 8:45 am] Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. comments or documents with the BILLING CODE 6717–01–P Commission relating to the merits of an The Public Reading Room is open from issue that may affect the responsibilities 8:30 a.m. to 4:30 p.m., Monday through of a particular resource agency, they Friday, excluding legal holidays. The must also serve a copy of the document ENVIRONMENTAL PROTECTION telephone number for the Public on that resource agency. A copy of all AGENCY Reading Room is (202) 566–1744, and other filings in reference to this the telephone number for the OPPT application must be accompanied by [EPA–HQ–OPPT–2003–0004; FRL–9986–69] Docket is (202) 566–0280. Please review proof of service on all persons listed in the visitor instructions and additional the service list prepared by the Access to Confidential Business information about the docket available Commission in this proceeding, in Information by Abt Associates Inc. at http://www.epa.gov/dockets. accordance with 18 CFR 4.34(b) and II. What action is the Agency taking? 385.2010. AGENCY: Environmental Protection Agency (EPA). Under EPA contract number GS–00F– Dated: February 19, 2019. ACTION: Notice. 252CA, order number EP–G18H–01464, Kimberly D. Bose, contractor Abt of 4550 Montgomery Secretary. SUMMARY: EPA has authorized its Avenue, Suite 800 North, Bethesda, MD [FR Doc. 2019–03266 Filed 2–25–19; 8:45 am] contractor, Abt Associates Inc. (Abt) of and 55 Wheeler Street, Cambridge, MA BILLING CODE 6717–01–P Rockville, MD, to access information will assist the Office of Pollution which has been submitted to EPA under Prevention and Toxics (OPPT) by all sections of the Toxic Substances providing support to the methodological DEPARTMENT OF ENERGY Control Act (TSCA). Some of the development of a uniform data output information may be claimed or and analytics of TRI/TSCA data Federal Energy Regulatory determined to be Confidential Business information; developing chemical Commission Information (CBI). profiles that focus on TSCA workplan [Docket No. IN12–17–000] DATES: Access to the confidential data chemicals, or on sets of chemicals based will occur no sooner than March 5, on commercial or industrial use; Total Gas & Power North America, 2019. provide support for the updates to the Aaron Hall and Therese Tran; Updated EasyRSEI the internal EPA and public FOR FURTHER INFORMATION CONTACT: Notice of Designation of Commission Qlik applications; create any new For technical information contact: Staff as Non-Decisional applications, as directed, including but Recie Reese, Environmental Assistance not limited to a RSEI-related pollution With respect to an order issued by the Division (7408M), Office of Pollution prevention Qlik App and expanded Commission on April 28, 2016 in the Prevention and Toxics, Environmental 1 TSCA Qlik application; and explore above-captioned docket, with the Protection Agency, 1200 Pennsylvania feasibility of integrating novel data exceptions noted below, the staff of the Ave. NW, Washington, DC 20460–0001; streams in support of TRI and TSCA- Office of Enforcement are designated as telephone number: (202) 564–8276; related efforts. non-decisional in deliberations by the email address: [email protected]. Commission in this docket. In accordance with 40 CFR 2.306(j), For general information contact: The EPA has determined that under EPA Accordingly, pursuant to 18 CFR TSCA-Hotline, ABVI-Goodwill, 422 385.2202 (2018), they will not serve as contract number GS–00F–252CA, order South Clinton Ave., Rochester, NY number EP–G18H–01464, Abt will advisors to the Commission or take part 14620; telephone number: (202) 554– in the Commission’s review of any offer require access to CBI submitted to EPA 1404; email address: TSCA-Hotline@ under all sections of TSCA to perform epa.gov. 1 Total Gas & Power North America, Aaron Hall successfully the duties specified under and Therese Tran, 155 FERC 61,105 (2016). SUPPLEMENTARY INFORMATION: the contract. Abt contractors will be

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given access to information submitted to displays a currently valid OMB control responses. EPA will consider the EPA under all sections. Some of the number. comments received and amend the ICR information may be claimed or DATES: Comments must be received on as appropriate. The final ICR package determined to be CBI. or before April 29, 2019. will then be submitted to OMB for EPA is issuing this notice to inform ADDRESSES: Submit your comments, review and approval. At that time, EPA all submitters of information under all referencing Docket ID No. EPA–HQ– will issue another Federal Register sections of TSCA that EPA may provide OAR–2019–0027, online using notice to announce the submission of Abt access to these CBI materials on a www.regulations.gov (our preferred the ICR to OMB and the opportunity to need-to-know basis only. All access to method), by email to A-and-R-Docket@ submit additional comments to OMB. TSCA CBI under this contract will take epa.gov; or by mail to EPA Docket Abstract: In response to the FY2008 place at EPA Headquarters and Abt’s Center, Environmental Protection Consolidated Appropriations Act (H.R. sites located in Bethesda, MD and Agency, Mail Code 28221T, 1200 2764; Pub. L. 110–161) and under Cambridge, MA in accordance with Pennsylvania Ave. NW, Washington, DC authority of the Clean Air Act, the EPA EPA’s TSCA CBI Protection Manual. 20460. finalized the Mandatory Reporting of Access to TSCA data, including CBI, EPA’s policy is that all comments Greenhouse Gases Rule (GHG Reporting will continue until December 28, 2022. received will be included in the public Rule) (74 FR 56260; October 30, 2009). If the contract is extended, this access docket without change including any The GHG Reporting Rule, which became will also continue for the duration of the personal information provided, unless effective on December 29, 2009, extended contract without further the comment includes profanity, threats, establishes reporting requirements for notice. information claimed to the Confidential certain large facilities and suppliers. It Abt’s contractor personnel will be Business Information (CBI) or other does not require control of greenhouse required to sign nondisclosure information whose disclosure is gases. Instead, it requires that sources agreements and will be briefed on restricted by statute. emitting GHGs above certain threshold appropriate security procedures before FOR FURTHER INFORMATION CONTACT: levels of carbon dioxide equivalent they are permitted access to TSCA CBI. Rachel Schmeltz, Climate Change (CO2e) monitor and report emissions. Authority: 15 U.S.C. 2601 et seq. Division, Office of Atmospheric Subsequent rules have promulgated Programs (MC–6207A), Environmental requirements for additional facilities, Dated: December 12, 2018. Protection Agency, 1200 Pennsylvania suppliers, and mobile sources; provided Pamela Myrick, Ave. NW, Washington, DC 20460; clarification and corrections to existing Director, Information Management Division, telephone number: (202) 343–9124; fax requirements; finalized confidentiality Office of Pollution Prevention and Toxics. number: (202) 343–2342; email address: business information (CBI) [FR Doc. 2019–03293 Filed 2–25–19; 8:45 am] [email protected]. determinations, amended recordkeeping BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: requirements, and implemented an Supporting documents which explain in alternative verification approach. detail the information that the EPA will Collectively, the GHG Reporting Rule ENVIRONMENTAL PROTECTION and its associated rulemakings are AGENCY be collecting are available in the public docket for this ICR. The docket can be referred to as the Greenhouse Gas viewed online at www.regulations.gov Reporting Program (GHGRP). [EPA–HQ–OAR–2019–0027; FRL–9989–96– or in person at the EPA Docket Center, The purpose for this ICR is to renew OAR] WJC West, Room 3334, 1301 and revise the GHG Reporting Rule ICR Constitution Ave. NW, Washington, DC. to update the burdens and costs. Proposed Information Collection Form Numbers: None. Request; Comment Request; The telephone number for the Docket Respondents/affected entities: Entities Information Collection Request for the Center is 202–566–1744. For additional potentially affected by this action are Greenhouse Gas Reporting Program information about EPA’s public docket, visit http://www.epa.gov/dockets. suppliers of certain products that will AGENCY: Environmental Protection Pursuant to section 3506(c)(2)(A) of emit GHG when released, combusted, or Agency. the PRA, the EPA is soliciting comments oxidized; facilities in certain industrial ACTION: Notice. and information to enable it to: (i) categories that emit greenhouse gases; Evaluate whether the proposed and facilities that emit 25,000 metric SUMMARY: The Environmental Protection collection of information is necessary tons or more of carbon dioxide Agency is planning to submit an for the proper performance of the equivalent (CO2e) per year. Information Collection Request (ICR), functions of the Agency, including Respondent’s obligation to respond: ‘‘Information Collection Request for the whether the information will have Mandatory (Section 114 of the Clean Air Greenhouse Gas Reporting Program’’ practical utility; (ii) evaluate the Act provides EPA authority to require (EPA ICR No. 2300.18, OMB Control No. accuracy of the Agency’s estimate of the the information mandated by the 2060–0629) to the Office of Management burden of the proposed collection of Greenhouse Gas Reporting Program and Budget (OMB) for review and information, including the validity of because such data will inform and are approval in accordance with the the methodology and assumptions used; relevant to future policy decisions). Paperwork Reduction Act. Before doing (iii) enhance the quality, utility, and Estimated number of respondents: so, EPA is soliciting public comments clarity of the information to be 13,654 (total). on specific aspects of the proposed collected; and (iv) minimize the burden Frequency of response: Annual. information collection request as of the collection of information on those Total estimated burden: 726,577 described below. This is a proposed who are to respond, including through hours (per year). Burden is defined at 5 extension of the ICR, which is currently the use of appropriate automated CFR 1320.03(b). approved through September 30, 2019. electronic, mechanical, or other Total estimated cost: $86,958,000 (per An Agency may not conduct or sponsor technological collection techniques or year), includes $28,802,000 annualized and a person is not required to respond other forms of information technology, capital or operation and maintenance to a collection of information unless it e.g., permitting electronic submission of costs.

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Changes in Estimates: There is a response actions include: Cooperation control, will assist EPA in obtaining decrease of 12,608 hours in total with periodic reviews; compliance with institutional controls on other estimated respondent burden compared and performance of activities related to properties, and will assist EPA with with the ICR currently approved by institutional controls; assistance with future review and maintenance of the OMB. The decrease reflects an community relations activities; property institutional controls. The settling adjustment in the number of clearance activities; oversight of traffic parties will assist EPA in performing respondents from the previous ICR, an management issues; and to cooperate community relation activities related to adjustment of labor rates and capital with OU1 remedy component the Panelyte Property and OU1, will costs to reflect 2017 dollars, and a placement on the Panelyte Property and assist in performing property clearing complete re-evaluation of the activities the performance of inspections of such activities (trees, brush, undergrowth) at and costs associated with all subparts of remedy components. the Panelyte Property related to OU1 the GHGRP. This decrease also reflects DATES: Comments must be post marked remedy components, and will perform the removal of burden hours from or received on or before March 28, 2019. inspections of OU1 remedy components collection of GHG-related data for ADDRESSES: The proposed Settlement placed on the Panelyte Property. The mobile sources, which are now captured and related site documents can be settling parties shall prepare and in other EPA ICR vehicles including viewed at the Superfund Records oversee implementation of the traffic OMB Control Nos. 2060–0287, 2060– Center, (SRC–7J), United States management plan related to 0292, 2060–0338, 2060–0641, 2060– Environmental Protection Agency, construction activities under the OU1 0680, and 2060–0710. Region 5, 77 W Jackson Blvd., Chicago, remedy. Dated: February 14, 2019. IL 60604, (312) 886–4465. Electronic The Settlement includes a covenant Paul M. Gunning, copies online will be found at by the United States not to sue the www.epa.gov/superfund/allied-paper- settling parties, pursuant to Sections Director, Climate Change Division, Office of Air and Radiation. kalamazoo. 106 and Section 107(a) of CERCLA, 42 U.S.C. 106 and 107(a). [FR Doc. 2019–03292 Filed 2–25–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 6560–50–P Further information or a copy of the II. Opportunity To Comment Settlement may be obtained from Diane Russell, Community Involvement A. General Information ENVIRONMENTAL PROTECTION Coordinator, U.S. EPA Region 5 For thirty (30) days following the date AGENCY Superfund Division Community of publication of this notice, the Agency Information Office, 1300 Bluff St., Suite will receive written comments relating [EPA–CERCLA Docket No. V–W–19–C–003; 140, Flint, MI 48504. Telephone: 989– to the Settlement. The Agency will FRL–9989–94–Region 5] 395–3493. Email: [email protected]. consider all comments received and Proposed CERCLA Administrative SUPPLEMENTARY INFORMATION: may modify or withdraw its consent to the Settlement if comments received Settlement Agreement and Order on I. Background Information Consent; City of Kalamazoo, Michigan, disclose facts or considerations which and City of Kalamazoo Brownfields In accordance with Section 122(i) of indicate that the Settlement is Redevelopment Authority; Allied Paper the Comprehensive Environmental inappropriate, improper, or inadequate. Portage Creek/Kalamazoo River Response, Compensation, and Liability Act, as amended (‘‘CERCLA’’), 42 U.S.C. B. Where do I send my comments or Superfund Site, Operable Unit 1, view responses? Panelyte Property, Kalamazoo 9622(i), notice is hereby given of a Michigan proposed Settlement pertaining to the Your comments should be mailed to Panelyte Property, a 22-acre parcel of Diane Russell, Community Involvement AGENCY: Environmental Protection land located in Kalamazoo, Michigan. Coordinator, U.S. EPA Region 5 Agency. The Panelyte Property is located Superfund Division Community ACTION: Notice of proposed Settlement adjacent to, and is partially Information Office, 1300 Bluff St., Suite Agreement and request for public contaminated by hazardous substances 140, Flint, MI 48504. Telephone: 989– comment. from, Operable Unit 1 (OU1) of the 395–3493. Email: [email protected]. Allied Paper Portage Creek/Kalamazoo Be sure to label the comments with the SUMMARY: The Environmental Protection River Superfund Site. The Settlement is Docket Number at the top of this notice Agency (EPA) hereby gives notice of a with the following settling parties: The and/or the property name. The Agency’s proposed Administrative Settlement City of Kalamazoo, Michigan and the response to any comments received will Agreement and Order on Consent City of Kalamazoo Brownfield be available for public inspection at the (Settlement) pertaining to a 22-acre Redevelopment Authority. The Superfund Records Center. parcel of land (the Panelyte Property) Settlement requires the settling parties located in Kalamazoo, Michigan. The to perform certain work and to comply C. What should I consider as I prepare Panelyte Property is located adjacent to, with property requirements. The settling my comments for EPA? and is partially contaminated by waste parties will cooperate with EPA in 1. Submitting Confidential Business from, Operable Unit 1 (OU1) of the potentially placing components of the Information (CBI). Do not submit ANY Allied Paper/Portage Creek/Kalamazoo EPA-selected remedy for OU1 on the information you think or know is CBI to River Superfund Site. EPA invites Panelyte Property. The settling parties EPA through an agency website or via public comment on the Settlement for will cooperate with EPA’s periodic email. Clearly mark on your written thirty (30) days following publication of reviews of the OU1 remedy, including comments all the information that you this notice. The Settlement requires the the compilation, reporting, and the claim to be CBI. If you mail EPA your City of Kalamazoo and the City of review and analysis of data, reports, and comments on a disk or CD–ROM (CD), Kalamazoo Brownfield Redevelopment other information in their possession. mark the outside of the CD as CBI and Authority to conduct certain short-term The settling parties will also place and then identify electronically within the and long-term response actions at the comply with any necessary institutional CD the specific information that is Panelyte Property and at OU1. These controls on properties they presently claimed as CBI. In addition to one

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complete version of your comments that and other Federal agencies to take this in Sections 4(i), 303 and 308 of the includes all the information claimed as opportunity to comment on the Communications Act of 1934, as CBI, you must submit for inclusion in following information collections. amended. the public docket a second copy of your Comments are requested concerning: Nature and Extent of Confidentiality: comments that does not contain the Whether the proposed collection of There is no need for confidentiality with information claimed as CBI. Information information is necessary for the proper this collection of information. marked as CBI will not be disclosed performance of the functions of the Privacy Impact Assessment: No except in accordance with procedures Commission, including whether the impact(s). set forth in 40 CFR part 2. information shall have practical utility; Needs and Uses: The information 2. Tips for Preparing Your Comments. the accuracy of the Commission’s collection requirements contained in 47 When submitting comments, remember burden estimate; ways to enhance the CFR 76.1713 state cable system to: quality, utility, and clarity of the operators shall establish a process for • Identify the subject of your information collected; ways to minimize resolving complaints from subscribers comments by the docket number and the burden of the collection of about the quality of the television signal the site name in the title of this notice information on the respondents, delivered. Commission and franchising or the Federal Register publication date including the use of automated authorities, upon request. These records and page number. collection techniques or other forms of shall be maintained for at least a one- • Follow directions—the agency may information technology; and ways to year period. Prior to being referred to ask you to respond to specific questions further reduce the information the Commission, complaints from or organize comments by referencing a collection burden on small business subscribers about the quality of the Code of Federal Regulations (CFR) part concerns with fewer than 25 employees. television signal delivered must be or section number. The FCC may not conduct or sponsor referred to the local franchising • Explain why you agree or disagree a collection of information unless it authority and the cable system operator. with the terms of the Settlement; suggest displays a currently valid Office of Federal Communications Commission. alternatives and substitute language for Management and Budget (OMB) control Marlene Dortch, your requested changes. number. No person shall be subject to Secretary, Office of the Secretary. • Describe any assumptions and any penalty for failing to comply with provide any technical information and/ a collection of information subject to the [FR Doc. 2019–03231 Filed 2–25–19; 8:45 am] or data that you used. PRA that does not display a valid OMB BILLING CODE 6712–01–P • If you estimate potential costs or control number. burdens, explain how you arrived at DATES: Written comments should be your estimate in sufficient detail to FEDERAL COMMUNICATIONS submitted on or before April 29, 2019. COMMISSION allow for it to be reproduced. If you anticipate that you will be • Provide specific examples to submitting comments but find it [OMB 3060–0600 and OMB 3060–0995] illustrate your concerns and suggest difficult to do so within the period of alternatives. Information Collections Being • time allowed by this notice, you should Explain your views as clearly as advise the contacts below as soon as Reviewed by the Federal possible, avoiding the use of profanity possible. Communications Commission Under or personal threats. Delegated Authority • Make sure to submit your ADDRESSES: Direct all PRA comments to AGENCY: comments by the identified comment Cathy Williams, FCC, via email: PRA@ Federal Communications period deadline. fcc.gov and to [email protected]. Commission. FOR FURTHER INFORMATION CONTACT: For ACTION: Notice and request for Dated: February 7, 2019. additional information about the comments. Thomas R. Short, information collection, contact Cathy Acting Director, Superfund Division. Williams at (202) 418–2918. SUMMARY: As part of its continuing effort [FR Doc. 2019–03291 Filed 2–25–19; 8:45 am] to reduce paperwork burdens, and as SUPPLEMENTARY INFORMATION: required by the Paperwork Reduction BILLING CODE 6560–50–P OMB Control Number: 3060–0500. Act of 1995 (PRA), the Federal Title: Section 76.1713, Resolution of Communications Commission (FCC or Complaints. FEDERAL COMMUNICATIONS Form Number: N/A. Commission) invites the general public COMMISSION Type of Review: Extension of a and other Federal agencies to take this opportunity to comment on the [OMB 3060–0500] currently approved collection. Respondents: Business or other for- following information collections. Comments are requested concerning: Information Collection Being Reviewed profit entities. Whether the proposed collection of by the Federal Communications Number of Respondents and information is necessary for the proper Commission Responses: 10,750 respondents and 21,500 responses. performance of the functions of the AGENCY: Federal Communications Estimated Hours per Response: 1–17 Commission, including whether the Commission. hours. information shall have practical utility; ACTION: Notice and request for Frequency of Response: the accuracy of the Commission’s comments. Recordkeeping and third-party burden estimate; ways to enhance the disclosure requirements; annual quality, utility, and clarity of the SUMMARY: As part of its continuing effort reporting requirement. information collected; ways to minimize to reduce paperwork burdens, and as Total Annual Burden: 193,500 hours. the burden of the collection of required by the Paperwork Reduction Total Annual Cost: None. information on the respondents, Act of 1995 (PRA), the Federal Obligation to Respond: Required to including the use of automated Communications Commission (FCC or obtain or retain benefits. The statutory collection techniques or other forms of Commission) invites the general public authority for this collection is contained information technology; and ways to

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further reduce the information Privacy Act Impact Assessment: No Estimated Number of Respondents collection burden on small business impact(s). and Responses: 10 respondents and 10 concerns with fewer than 25 employees. Needs and Uses: A request for responses. The FCC may not conduct or sponsor extension of this information collection Estimated Time per Response: 1.5 a collection of information unless it (no change in requirements) will be hours to 2 hours. displays a currently valid Office of submitted to the Office of Management Frequency of Response: On occasion Management and Budget (OMB) control and Budget (OMB) after this 60-day reporting requirement. number. No person shall be subject to comment period in order to obtain the Obligation to Respond: Required to any penalty for failing to comply with full three year clearance from OMB. obtain or retain benefits. Statutory a collection of information subject to the authority for this information collection The Commission’s auction rules and is contained in sections 154(i), 309(j), PRA that does not display a valid OMB related requirements are designed to control number. and 1452(a)(3) of the Communications ensure that the competitive bidding Act, as amended, 47 U.S.C. 4(i), DATES: Written comments should be process is limited to serious qualified 309(j)(5), 1452(a)(3), and sections submitted on or before April 29, 2019. applicants, deter possible abuse of the If you anticipate that you will be 1.2105(c) and 1.2205 of the bidding and licensing process, and Commission’s rules, 47 CFR 1.2105(c), submitting comments but find it enhance the use of competitive bidding difficult to do so within the period of 1.2205. to assign Commission licenses in Estimated Total Annual Burden: 50 time allowed by this notice, you should furtherance of the public interest. The hours. advise the contacts below as soon as information collected on FCC Form 175 Total Annual Costs: $9,000. possible. is used by the Commission to determine Nature and Extent of Confidentiality: ADDRESSES: Direct all PRA comments to if an applicant is legally, technically, The Commission will take all reasonable Cathy Williams, FCC, via email: PRA@ and financially qualified to participate steps to protect the confidentiality of all fcc.gov and to [email protected]. in a Commission auction. Additionally, Commission-held data of a reverse FOR FURTHER INFORMATION CONTACT: For if an applicant applies for status as a broadcast incentive auction applicant additional information about the particular type of auction participant consistent with the confidentiality information collection, contact Cathy pursuant to Commission rules, the requirements of the Spectrum Act and Williams at (202) 418–2918. Commission uses information collected the Commission’s rules. See 47 U.S.C. on FCC Form 175 to determine whether SUPPLEMENTARY INFORMATION: 1452(a)(3); 47 CFR 1.2206. In addition, OMB Control Number: 3060–0600. the applicant is eligible for the status to the extent necessary, auction Title: Application to Participate in an requested. Commission staff reviews the applicants and other covered parties FCC Auction, FCC Form 175. information collected on FCC Form 175 may request confidential treatment Form Number: FCC Form 175. for a particular auction as part of the pursuant to section 0.459 of the Type of Review: Extension of a pre-auction process, prior to the auction Commission’s rules, 47 CFR 0.459, for currently approved collection. being held. Staff determines whether any report of a prohibited Respondents: Business or other for- each applicant satisfies the communication submitted to the profit entities, not-for-profit institutions, Commission’s requirements to Commission that is not already being and state, local or tribal governments. participate in the auction and, if treated as confidential. Estimated Number of Respondents applicable, is eligible for the status as a Privacy Act Impact Assessment: No and Responses: 500 respondents and particular type of auction participant it impact(s). 500 responses. requested. Without the information Needs and Uses: A request for Estimated Time per Response: 90 collected on FCC Form 175, the extension of this information collection minutes. Commission will not be able to (no change in requirements) will be Frequency of Response: On occasion determine if an applicant is legally, submitted to the Office of Management reporting requirement. technically, and financially qualified to and Budget (OMB) after this 60-day Obligation to Respond: Required to participate in a Commission auction and comment period in order to obtain the obtain or retain benefits. Statutory has complied with the various full three year clearance from OMB. authority for this information collection applicable regulatory and statutory The Commission’s rules prohibiting is contained in sections 154(i) and auction requirements for such certain communications in Commission 309(j)(5) of the Communications Act, as participation. The Commission plans to auctions are designed to reinforce amended, 47 U.S.C. 4(i), 309(j)(5), and continue to use the FCC Form 175 for existing antitrust laws, facilitate sections 1.2105, 1.2110, 1.2112 of the its upcoming non-reverse spectrum detection of collusive conduct, and Commission’s rules, 47 CFR 1.2105, auctions, including the forward auction deter anticompetitive behavior, without 1.2110, 1.2112. component of any incentive auction, being so strict as to discourage pro- Estimated Total Annual Burden: 750 collecting only the information competitive arrangements between hours. necessary for each particular auction. auction participants. They also help Total Annual Costs: None. OMB Control Number: 3060–0995. assure participants that the auction Nature and Extent of Confidentiality: process will be fair and objective, and Information collected on FCC Form 175 Title: Section 1.2105(c), Bidding not subject to collusion. The is made available for public inspection, Application and Certification information collected under this and the Commission is not requesting Procedures; Sections 1.2105(c) and information collection allows the that respondents submit confidential 1.2205, Prohibition of Certain Commission to enforce the prohibition information on FCC Form 175. Communications. on auction applicants and other covered Respondents seeking to have Form Number: N/A. parties by making clear the information collected on FCC Form 175 Type of Review: Extension of a responsibility of parties who receive withheld from public inspection may currently approved collection. information that potentially violates the request confidential treatment of such Respondents: Business or other for- rules to promptly report to the information pursuant to section 0.459 of profit entities, not-for-profit institutions, Commission. It also enables the the Commission’s rules, 47 CFR 0.459. and state, local or tribal governments. Commission to ensure that no bidder

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gains an unfair advantage over other meeting on March 8, 2019, will be the Comments are requested concerning: bidders in its auctions, thereby eighth and final meeting of the CSRIC Whether the proposed collection of enhancing the competitiveness and under the current charter. The FCC will information is necessary for the proper fairness of Commission spectrum attempt to accommodate as many performance of the functions of the auctions. The information collected will attendees as possible; however, Commission, including whether the be reviewed and, if warranted, referred admittance will be limited to seating information shall have practical utility; to the Commission’s Enforcement availability. The Commission will the accuracy of the Commission’s Bureau for possible investigation and provide audio and/or video coverage of burden estimate; ways to enhance the administrative action. The Commission the meeting over the internet from the quality, utility, and clarity of the may also refer allegations of FCC’s web page at http://www.fcc.gov/ information collected; ways to minimize anticompetitive auction conduct to the live. The public may submit written the burden of the collection of Department of Justice for investigation. comments before the meeting to Jeffery information on the respondents, Federal Communications Commission. Goldthorp, CSRIC Designated Federal including the use of automated Marlene Dortch, Officer, by email to jeffery.goldthorp@ collection techniques or other forms of fcc.gov or U.S. Postal Service Mail to information technology; and ways to Secretary, Office of the Secretary. Jeffery Goldthorp, Associate Bureau further reduce the information [FR Doc. 2019–03232 Filed 2–25–19; 8:45 am] Chief, Public Safety and Homeland collection burden on small business BILLING CODE 6712–01–P Security Bureau, Federal concerns with fewer than 25 employees. Communications Commission, 445 12th The FCC may not conduct or sponsor Street SW, Room 7–A325, Washington, a collection of information unless it FEDERAL COMMUNICATIONS DC 20554. displays a currently valid Office of COMMISSION Open captioning will be provided for Management and Budget (OMB) control Federal Advisory Committee Act; this event. Other reasonable number. No person shall be subject to Communications Security, Reliability, accommodations for people with any penalty for failing to comply with and Interoperability Council disabilities are available upon request. a collection of information subject to the Requests for such accommodations PRA that does not display a valid OMB AGENCY: Federal Communications should be submitted via email to control number. Commission. [email protected] or by calling the DATES: Written comments should be ACTION: Notice of public meeting. Consumer & Governmental Affairs submitted on or before April 29, 2019. Bureau at (202) 418–0530 (voice), (202) If you anticipate that you will be SUMMARY: In accordance with the 418–0432 (tty). Such requests should submitting comments but find it Federal Advisory Committee Act, this include a detailed description of the difficult to do so within the period of notice advises interested persons that accommodation needed. In addition, time allowed by this notice, you should the Federal Communications please include a way the FCC can advise the contacts below as soon as Commission’s (FCC or Commission) contact you if it needs more possible. Communications Security, Reliability, information. Please allow at least five ADDRESSES: Direct all PRA comments to and Interoperability Council (CSRIC) VI days’ advance notice; last-minute Cathy Williams, FCC, via email: PRA@ will hold its eighth and final meeting. requests will be accepted, but may be fcc.gov and to [email protected]. DATES: March 8, 2019. impossible to fill. FOR FURTHER INFORMATION CONTACT: ADDRESSES: Federal Communications For Federal Communications Commission. additional information about the Commission, Room TW–C305 Marlene Dortch, (Commission Meeting Room), 445 12th information collection, contact Cathy Secretary. Street SW, Washington, DC 20554. Williams at (202) 418–2918. [FR Doc. 2019–03233 Filed 2–25–19; 8:45 am] SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: BILLING CODE 6712–01–P OMB Control No.: 3060–0999. Jeffery Goldthorp, Designated Federal Title: Hearing Aid Compatibility Officer, (202) 418–1096 (voice) or Status Report and Section 20.19, [email protected] (email); or FEDERAL COMMUNICATIONS Hearing Aid-Compatible Mobile Suzon Cameron, Deputy Designated COMMISSION Handsets (Hearing Aid Compatibility Federal Officer, (202) 418–1916 (voice) [OMB 3060–0999] Act). or [email protected] (email). Form Number: FCC Form 655. SUPPLEMENTARY INFORMATION: The Information Collections Being Type of Review: Revision of a meeting will be held on March 8, 2019, Reviewed by the Federal currently approved collection. from 1:00 p.m. to 5:00 p.m. in the Communications Commission Respondents: Business or other for- Commission Meeting Room of the profit entities. Federal Communications Commission, AGENCY: Federal Communications Number of Respondents: 934 Room TW–C305, 445 12th Street SW, Commission. respondents; 934 responses. Washington, DC 20554. ACTION: Notice and request for Estimated Time per Response: The CSRIC is a Federal Advisory comments. 13.9710921 hours per response Committee that will provide (average). recommendations to the FCC regarding SUMMARY: As part of its continuing effort Frequency of Response: On occasion best practices and actions the FCC can to reduce paperwork burdens, and as and annual reporting requirements, take to help ensure the security, required by the Paperwork Reduction Recordkeeping requirement and third- reliability, and interoperability of Act of 1995 (PRA), the Federal party disclosure requirement. communications systems. On March 19, Communications Commission (FCC or Obligation to Respond: Required to 2017, the FCC, pursuant to the Federal Commission) invites the general public obtain or retain benefits. Statutory Advisory Committee Act, renewed the and other Federal agencies to take this authority for this information collection charter for the CSRIC for a period of two opportunity to comment on the is contained in 47 U.S.C. Sections 151, years through March 18, 2019. The following information collections. 154(i), 157, 160, 201, 202, 214, 301, 303,

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308, 309(j), 310 and 610 of the and its instructions implement the new with Hamilton Bancorp, Townson, MD, Communications Act of 1934, as certification compliance requirement for and thereby indirectly acquire Hamilton amended. service providers and maintain the Bank, Townson, Maryland. Total Annual Burden: 13,049 hours. existing compliance requirements for B. Federal Reserve Bank of Atlanta Total Annual Cost: No cost. device manufacturers. These changes to (Kathryn Haney, Assistant Vice Privacy Impact Assessment: No the form reduce service providers’ President) 1000 Peachtree Street NE, impact. regulatory burden while continuing to Atlanta, Georgia 30309. Comments can Nature and Extent of Confidentiality: allow the Commission to monitor also be sent electronically to Information requested in the reports compliance with the hearing aid [email protected]: may include confidential information. compatibility rules. 1. LexPark Holdings—STC, LLC, However, covered entities can request SouthernTrust Group, LP & that such materials submitted to the Federal Communications Commission. Marlene Dortch, SouthernTrust Holdings, Inc., Orlando, Commission be withheld from public Florida; to become a bank holding Secretary, Office of the Secretary. inspection. company by acquiring voting shares of Needs and Uses: After the 60-day [FR Doc. 2019–03234 Filed 2–25–19; 8:45 am] First City Bank of Florida, Fort Walton comment period expires, the BILLING CODE 6712–01–P Beach, Florida. Commission will submit the revised information collection to the Office of Board of Governors of the Federal Reserve Management and Budget (OMB) to FEDERAL RESERVE SYSTEM System, February 21, 2019. obtain a full three-year clearance. The Yao-Chin Chao, changes being made to the information Formations of, Acquisitions by, and Assistant Secretary of the Board. collect concern the Commission’s Mergers of Bank Holding Companies [FR Doc. 2019–03297 Filed 2–25–19; 8:45 am] wireless hearing aid combability rules BILLING CODE P The companies listed in this notice as they relate to the obligations of have applied to the Board for approval, wireless service providers to post pursuant to the Bank Holding Company certain information on their websites, Act of 1956 (12 U.S.C. 1841 et seq.) DEPARTMENT OF HEALTH AND retain information and to file annual (BHC Act), Regulation Y (12 CFR part HUMAN SERVICES compliance certifications. No changes 225), and all other applicable statutes are being made to the website posting Food and Drug Administration and regulations to become a bank and reporting burdens of wireless holding company and/or to acquire the [Docket No. FDA–2018–D–4367] handset manufacturers. Further, no assets or the ownership of, control of, or changes are being made to the the power to vote shares of a bank or Bioavailability Studies Submitted in information collection as related to bank holding company and all of the New Drug Applications or standards development, labeling and banks and nonbanking companies Investigational New Drug disclosure requirements, and the owned by the bank holding company, Applications—General Considerations; approved number of estimated including the companies listed below. Draft Guidance for Industry; respondents/responses. The applications listed below, as well Availability The revisions to the information as other related filings required by the AGENCY: Food and Drug Administration, collection are necessitated by a Report Board, are available for immediate HHS. and Order in WT Docket No. 17–228, inspection at the Federal Reserve Bank FCC 18–167, adopted on November 15, indicated. The applications will also be ACTION: Notice of availability. 2018. In this Report and Order, the available for inspection at the offices of SUMMARY: The Food and Drug Commission revised its rules requiring the Board of Governors. Interested service providers to post on their Administration (FDA or Agency) is persons may express their views in announcing the availability of a draft publicly accessible websites information writing on the standards enumerated in regarding the hearing aid compatibility guidance for industry entitled the BHC Act (12 U.S.C. 1842(c)). If the ‘‘Bioavailability Studies Submitted in of their offered handsets and required proposal also involves the acquisition of NDAs or INDs—General them to retain certain information a nonbanking company, the review also Considerations.’’ This draft guidance regarding the hearing aid compatibility includes whether the acquisition of the provides recommendations to sponsors of handsets they previously offered. nonbanking company complies with the planning to include bioavailability (BA) Through this information, consumers standards in section 4 of the BHC Act information for drug products in will have access to the most recent data (12 U.S.C. 1843). Unless otherwise investigational new drug applications about hearing aid-compatible handsets noted, nonbanking activities will be (INDs), new drug applications (NDAs), and the Commission will be able to conducted throughout the United States. ensure compliance with the hearing aid Unless otherwise noted, comments and NDA supplements. This draft compatibility rules and requirements. In regarding each of these applications guidance revises and replaces FDA’s addition, the Commission determined must be received at the Reserve Bank March 2014 draft guidance for industry that service providers are no longer indicated or the offices of the Board of entitled ‘‘Bioavailability and required to file FCC Form 655 on an Governors not later than March 25, Bioequivalence Studies Submitted in annual basis. Instead, providers must 2019. NDAs or INDs—General file an annual certification indicating A. Federal Reserve Bank of Considerations,’’ which addresses BA or whether they are compliant with the Philadelphia (William Spaniel, Senior bioequivalence (BE) studies for INDs, hearing aid compatibility rules. Vice President) 100 North 6th Street, NDAs, and NDA supplements. As part of these revisions to the Philadelphia, Pennsylvania 19105– DATES: Submit either electronic or wireless hearing aid compatibility 1521. Comments can also be sent written comments on the draft guidance information collection, the Commission electronically to by May 28, 2019 to ensure that the is requesting approval of certain [email protected]: Agency considers your comment on this changes to the form and the related 1. Orrstown Financial Services, draft guidance before it begins work on instructions. These changes to the form Shippensburg, Pennsylvania; to merge the final version of the guidance.

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ADDRESSES: You may submit comments information you claim to be confidential Considerations.’’ Determining the BA of on any guidance at any time as follows: with a heading or cover note that states formulations is critical during the life ‘‘THIS DOCUMENT CONTAINS cycle of drug products and aids in Electronic Submissions CONFIDENTIAL INFORMATION.’’ The FDA’s evaluation of the safety and Submit electronic comments in the Agency will review this copy, including effectiveness of a product in an IND, following way: the claimed confidential information, in NDA, or NDA supplements. This draft • Federal eRulemaking Portal: its consideration of comments. The guidance provides recommendations to https://www.regulations.gov. Follow the second copy, which will have the sponsors planning to include BA instructions for submitting comments. claimed confidential information information for drug products in INDs, Comments submitted electronically, redacted/blacked out, will be available NDAs, and NDA supplements. This including attachments, to https:// for public viewing and posted on draft guidance contains www.regulations.gov will be posted to https://www.regulations.gov. Submit recommendations on how to meet the the docket unchanged. Because your both copies to the Dockets Management BA requirements set forth in 21 CFR comment will be made public, you are Staff. If you do not wish your name and part 320 as they apply to dosage forms solely responsible for ensuring that your contact information to be made publicly intended for oral administration. The comment does not include any available, you can provide this draft guidance is also applicable to non- confidential information that you or a information on the cover sheet and not orally administered drug products when third party may not wish to be posted, in the body of your comments and you it is appropriate to rely on systemic such as medical information, your or must identify this information as exposure measures to determine the BA anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked of a drug (e.g., transdermal delivery confidential business information, such as ‘‘confidential’’ will not be disclosed systems and certain rectal and nasal as a manufacturing process. Please note except in accordance with 21 CFR 10.20 drug products). The draft guidance that if you include your name, contact and other applicable disclosure law. For provides recommendations on information, or other information that more information about FDA’s posting conducting relative BA studies during identifies you in the body of your of comments to public dockets, see 80 the IND period for an NDA and BE comments, that information will be FR 56469, September 18, 2015, or access studies during the postapproval period posted on https://www.regulations.gov. • the information at: https://www.gpo.gov/ for certain changes to drug products. If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- with confidential information that you 23389.pdf. This draft guidance is being issued do not wish to be made available to the Docket: For access to the docket to consistent with FDA’s good guidance public, submit the comment as a read background documents or the practices regulation (21 CFR 10.115). written/paper submission and in the electronic and written/paper comments The draft guidance, when finalized, will manner detailed (see ‘‘Written/Paper received, go to https:// represent the current thinking of FDA Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the on ‘‘Bioavailability Studies in NDAs or INDs—General Considerations.’’ It does Written/Paper Submissions docket number, found in brackets in the heading of this document, into the not establish any rights for any person Submit written/paper submissions as ‘‘Search’’ box and follow the prompts and is not binding on FDA or the public. follows: You can use an alternative approach if • Mail/Hand delivery/Courier (for and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, it satisfies the requirements of the written/paper submissions): Dockets applicable statutes and regulations. This Management Staff (HFA–305), Food and Rockville, MD 20852. You may submit comments on any guidance is not subject to Executive Drug Administration, 5630 Fishers guidance at any time (see 21 CFR Order 12866. Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments 10.115(g)(5)). II. Paperwork Reduction Act of 1995 submitted to the Dockets Management Submit written requests for single Staff, FDA will post your comment, as copies of the draft guidance to the This draft guidance refers to well as any attachments, except for Division of Drug Information, Center for previously approved collections of information submitted, marked and Drug Evaluation and Research, Food information found in FDA regulations. identified, as confidential, if submitted and Drug Administration, 10001 New These collections of information are as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, subject to review by the Office of Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– Management and Budget (OMB) under must include the Docket No. FDA– 0002. Send one self-addressed adhesive the Paperwork Reduction Act of 1995 2018–D–4367 for ‘‘Bioavailability label to assist that office in processing (44 U.S.C. 3501–3520). The collection of Studies Submitted in NDAs or INDs— your requests. See the SUPPLEMENTARY information submitted under 21 CFR General Considerations.’’ Received INFORMATION section for electronic part 312 (INDs) has been approved comments will be placed in the docket access to the draft guidance document. under OMB control number 0910–0014; and, except for those submitted as FOR FURTHER INFORMATION CONTACT: and the collection of information ‘‘Confidential Submissions,’’ publicly Dakshina Chilukuri, Center for Drug submitted under 21 CFR part 314 viewable at https://www.regulations.gov Evaluation and Research, Food and (NDAs) has been approved under OMB or at the Dockets Management Staff Drug Administration, 10903 New control number 0910–0001. between 9 a.m. and 4 p.m., Monday Hampshire Ave., Silver Spring, MD III. Electronic Access through Friday. 20993–0002, 301–796–1515. • Confidential Submissions—To SUPPLEMENTARY INFORMATION: Persons with access to the internet submit a comment with confidential may obtain the draft guidance at either information that you do not wish to be I. Background https://www.fda.gov/Drugs/ made publicly available, submit your FDA is announcing the availability of GuidanceCompliance comments only as a written/paper a draft guidance for industry entitled RegulatoryInformation/Guidances/ submission. You should submit two ‘‘Bioavailability Studies Submitted in default.htm or https:// copies total. One copy will include the NDAs or INDs—General www.regulations.gov.

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Dated: February 20, 2019. • If you want to submit a comment FR 56469, September 18, 2015, or access Lowell J. Schiller, with confidential information that you the information at: https://www.gpo.gov/ Acting Associate Commissioner for Policy. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- [FR Doc. 2019–03246 Filed 2–25–19; 8:45 am] public, submit the comment as a 23389.pdf. written/paper submission and in the BILLING CODE 4164–01–P Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments DEPARTMENT OF HEALTH AND Written/Paper Submissions received, go to https:// HUMAN SERVICES Submit written/paper submissions as www.regulations.gov and insert the Food and Drug Administration follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for heading of this document, into the ‘‘Search’’ box and follow the prompts [Docket No. FDA–2018–N–3017] written/paper submissions): Dockets Management Staff (HFA–305), Food and and/or go to the Dockets Management Prescription Drug-Use-Related Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Software; Establishment of a Public Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. • Docket; Request for Comments; For written/paper comments Submit written requests for single Reopening of Comment Period submitted to the Dockets Management copies of the notice to the Division of Staff, FDA will post your comment, as Drug Information, Center for Drug AGENCY: Food and Drug Administration, well as any attachments, except for Evaluation and Research, Food and HHS. information submitted, marked and Drug Administration, 10001 New ACTION: Notice of availability; reopening identified, as confidential, if submitted Hampshire Ave. Hillandale Building, as detailed in ‘‘Instructions.’’ of comment period. 4th Floor, Silver Spring, MD 20993– Instructions: All submissions received 0002. Send one self-addressed adhesive SUMMARY: must include the Docket No. FDA– The Food and Drug label to assist that office in processing Administration (FDA or Agency) is 2018–N–3017 for ‘‘Prescription Drug- your requests. See the SUPPLEMENTARY reopening the comment period for the Use-Related Software; Establishment of INFORMATION section for electronic notice entitled ‘‘Prescription Drug-Use- a Public Docket; Request for access to the draft guidance document. Related Software; Establishment of a Comments.’’ Received comments will be Public Docket; Request for Comments’’ placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: that appeared in the Federal Register of those submitted as ‘‘Confidential Chris Wheeler, Center for Drug November 20, 2018. The Agency is Submissions,’’ publicly viewable at Evaluation and Research, Food and taking this action to allow interested https://www.regulations.gov or at the Drug Administration, 10903 New persons additional time to submit Dockets Management Staff between 9 Hampshire Ave. Bldg. 51, Rm. 3330, comments. a.m. and 4 p.m., Monday through Silver Spring, MD 20993, 301–796– Friday. 0151, [email protected]. DATES: FDA is reopening the comment • Confidential Submissions—To period for the notice published on submit a comment with confidential SUPPLEMENTARY INFORMATION: November 20, 2018 (83 FR 58574). information that you do not wish to be Submit either electronic or written made publicly available, submit your I. Background comments by April 29, 2019. comments only as a written/paper In the Federal Register of November ADDRESSES: You may submit comments submission. You should submit two 20, 2018 (83 FR 58574), FDA published as follows: copies total. One copy will include the a notice with a 60-day comment period information you claim to be confidential Electronic Submissions to request comments on the notice with a heading or cover note that states entitled ‘‘Prescription Drug-Use-Related Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Software; Establishment of a Public following way: CONFIDENTIAL INFORMATION.’’ The Docket; Request for Comments.’’ FDA is • Federal eRulemaking Portal: Agency will review this copy, including reopening the comment period until https://www.regulations.gov. Follow the the claimed confidential information, in April 29, 2019. The Agency believes instructions for submitting comments. its consideration of comments. The that an additional 60 days will allow Comments submitted electronically, second copy, which will have the adequate time for interested persons to including attachments, to https:// claimed confidential information submit comments. www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on II. Electronic Access comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management Persons with access to the internet comment does not include any Staff. If you do not wish your name and may obtain the notice at either https:// confidential information that you or a contact information to be made publicly www.fda.gov/Drugs/ third party may not wish to be posted, available, you can provide this GuidanceCompliance such as medical information, your or information on the cover sheet and not RegulatoryInformation/Guidances/ anyone else’s Social Security number, or in the body of your comments and you default.htm or https:// confidential business information, such must identify this information as www.regulations.gov. as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Dated: February 20, 2019. that if you include your name, contact as ‘‘confidential’’ will not be disclosed information, or other information that except in accordance with 21 CFR 10.20 Lowell J. Schiller, identifies you in the body of your and other applicable disclosure law. For Acting Associate Commissioner for Policy. comments, that information will be more information about FDA’s posting [FR Doc. 2019–03241 Filed 2–25–19; 8:45 am] posted on https://www.regulations.gov. of comments to public dockets, see 80 BILLING CODE 4164–01–P

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DEPARTMENT OF HEALTH AND comments, that information will be of comments to public dockets, see 80 HUMAN SERVICES posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • If you want to submit a comment the information at: https://www.gpo.gov/ Food and Drug Administration with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- do not wish to be made available to the 23389.pdf. [Docket No. FDA–2018–D–4368] public, submit the comment as a Docket: For access to the docket to written/paper submission and in the Assessing the Effects of Food on read background documents or the manner detailed (see ‘‘Written/Paper Drugs in Investigational New Drug electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). Applications and New Drug received, go to https:// Applications—Clinical Pharmacology Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the Considerations; Draft Guidance for Submit written/paper submissions as Industry; Availability heading of this document, into the follows: ‘‘Search’’ box and follow the prompts • Mail/Hand delivery/Courier (for AGENCY: Food and Drug Administration, and/or go to the Dockets Management HHS. written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and ACTION: Notice of availability. Rockville, MD 20852. Drug Administration, 5630 Fishers You may submit comments on any SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR • For written/paper comments Administration (FDA or Agency) is 10.115(g)(5)). submitted to the Dockets Management announcing the availability of a draft Submit written requests for single Staff, FDA will post your comment, as guidance for industry entitled copies of the draft guidance to the well as any attachments, except for ‘‘Assessing the Effects of Food on Drugs Division of Drug Information, Center for information submitted, marked and in INDs and NDAs—Clinical Drug Evaluation and Research, Food identified, as confidential, if submitted Pharmacology Considerations.’’ This as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New draft guidance provides Instructions: All submissions received Hampshire Ave., Hillandale Building, recommendations to sponsors planning must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– to conduct food-effect trials for orally 2018–D–4368 for ‘‘Assessing the Effects 0002. Send one self-addressed adhesive administered products as part of of Food on Drugs in INDs and NDAs— label to assist that office in processing investigational new drug applications Clinical Pharmacology Considerations.’’ your requests. See the SUPPLEMENTARY (INDs), new drug applications (NDAs), Received comments will be placed in INFORMATION section for electronic and supplements to these applications. the docket and, except for those access to the draft guidance document. This draft guidance, when final, revises submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: and replaces part of the 2002 FDA Submissions,’’ publicly viewable at Vikram Arya or Brian Booth, Center for guidance for industry entitled ‘‘Food- https://www.regulations.gov or at the Drug Evaluation and Research, Food Effect Bioavailability and Fed Dockets Management Staff between 9 and Drug Administration, 10903 New Bioequivalence Studies’’ (2002 Food a.m. and 4 p.m., Monday through Hampshire Ave., Silver Spring, MD Effect Guidance). Friday. 20993–0002, 301–796–1499 or 301– DATES: Submit either electronic or • Confidential Submissions—To 796–1508. written comments on the draft guidance submit a comment with confidential SUPPLEMENTARY INFORMATION: by April 29, 2019 to ensure that the information that you do not wish to be Agency considers your comment on this made publicly available, submit your I. Background draft guidance before it begins work on comments only as a written/paper FDA is announcing the availability of the final version of the guidance. submission. You should submit two a draft guidance for industry entitled ADDRESSES: You may submit comments copies total. One copy will include the ‘‘Assessing the Effects of Food on Drugs on any guidance at any time as follows: information you claim to be confidential in INDs and NDAs—Clinical with a heading or cover note that states Pharmacology Considerations.’’ Food- Electronic Submissions ‘‘THIS DOCUMENT CONTAINS drug interactions can significantly Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The impact patient outcomes by affecting the following way: Agency will review this copy, including pharmacokinetics and • Federal eRulemaking Portal: the claimed confidential information, in pharmacodynamics of some drugs. https://www.regulations.gov. Follow the its consideration of comments. The These interactions can potentially lead instructions for submitting comments. second copy, which will have the to reduced drug absorption and Comments submitted electronically, claimed confidential information decreased efficacy or increased drug including attachments, to https:// redacted/blacked out, will be available absorption and increased efficacy. Food www.regulations.gov will be posted to for public viewing and posted on can also have either a positive or the docket unchanged. Because your https://www.regulations.gov. Submit negative effect on the incidence and comment will be made public, you are both copies to the Dockets Management severity of adverse events associated solely responsible for ensuring that your Staff. If you do not wish your name and with drug use. The timely conduct of comment does not include any contact information to be made publicly well-designed food-effect studies is confidential information that you or a available, you can provide this critical to optimize the safety and third party may not wish to be posted, information on the cover sheet and not efficacy of the drug product. This draft such as medical information, your or in the body of your comments and you guidance provides recommendations on anyone else’s Social Security number, or must identify this information as the following items: (1) When and how confidential business information, such ‘‘confidential.’’ Any information marked to conduct food-effect studies; (2) how as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed to report the study results; and (3) how that if you include your name, contact except in accordance with 21 CFR 10.20 to include appropriate language information, or other information that and other applicable disclosure law. For regarding administration of the drug identifies you in the body of your more information about FDA’s posting with food in the labeling.

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FDA is specifically seeking feedback approved under OMB control number North Bethesda, MD 20852, 301–796– on the following issues: 0910–0572. The collections of 3794, [email protected]. • Please comment on the definition of information related to SUPPLEMENTARY INFORMATION: In the meal content. Should meal types be pharmacogenomic data have been compliance with 44 U.S.C. 3507, FDA defined solely by the calorie and fat approved under OMB control number has submitted the following proposed content, or should carbohydrates and 0910–0557. collection of information to OMB for proteins also be included? review and clearance. • Please comment on the definition of III. Electronic Access the low-fat meal. Are the 400–500 Persons with access to the internet Foreign Supplier Verification Programs calories and 25 percent fat a sufficient may obtain the draft guidance at either (FSVP) for Food Importers definition of a low-fat meal (refer also to https://www.fda.gov/Drugs/ OMB Control Number 0910–0752— table 2)? GuidanceCompliance • Extension Please comment on the RegulatoryInformation/Guidances/ Biopharmaceutics Classification default.htm or https:// This information collection supports System-based waiver for food-effect www.regulations.gov. FDA regulations at 21 CFR part 1, trials. Does current science support this Dated: February 20, 2019. subpart L—Foreign Supplier biowaiver? Verification Programs for Food Lowell J. Schiller, Information on fed bioequivalence Importers, as well as associated (BE) studies to be submitted in Acting Associate Commissioner for Policy. guidance. As amended by the FDA Food abbreviated new drug applications [FR Doc. 2019–03247 Filed 2–25–19; 8:45 am] Safety Modernization Act (FSMA) (Pub. (ANDAs) can be found in the FDA draft BILLING CODE 4164–01–P L. 111–353), the Federal Food, Drug, guidance for industry entitled and Cosmetic Act (FD&C Act) enables ‘‘Bioequivalence Studies with the Agency to better protect the public Pharmacokinetic Endpoints for Drugs DEPARTMENT OF HEALTH AND health by helping to ensure the safety Submitted Under an ANDA.’’ Specific HUMAN SERVICES and security of the food supply. The recommendations concerning fed Food and Drug Administration regulations are intended to help ensure comparability trials are now found in that food imported into the United the FDA draft guidance for industry [Docket No. FDA–2011–N–0143] States is produced in compliance with entitled ‘‘Bioavailability Studies specific processes and procedures, Submitted in NDAs or INDs—General Agency Information Collection including reasonably appropriate risk- Considerations.’’ When finalized these Activities; Submission for Office of based preventive controls. The guidances will represent the current Management and Budget Review; regulations establish that importers of thinking of FDA on these topics. Comment Request; Foreign Supplier foods must develop, maintain, and This draft guidance is being issued Verification Programs for Food follow an FSVP that provides adequate consistent with FDA’s good guidance Importers assurances that a foreign supplier is practices regulation (21 CFR 10.115). producing the food in compliance with The draft guidance, when finalized, will AGENCY: Food and Drug Administration, processes and procedures that provide represent the current thinking of FDA HHS. at least the same level of public health on ‘‘Assessing the Effects of Food on ACTION: Notice. protection as those required under Drugs in INDs and NDAs—Clinical section 418 of the FD&C Act (21 U.S.C. SUMMARY: Pharmacology Considerations.’’ It does The Food and Drug 350g) (regarding hazard analysis and not establish any rights for any person Administration (FDA) is announcing risk-based preventive controls for and is not binding on FDA or the public. that a proposed collection of certain foods) or 419 (21 U.S.C. 350h) You can use an alternative approach if information has been submitted to the (regarding standards for produce safety), it satisfies the requirements of the Office of Management and Budget if either is applicable, and the applicable statutes and regulations. This (OMB) for review and clearance under implementing regulations, and is guidance is not subject to Executive the Paperwork Reduction Act of 1995. producing the food in compliance with Order 12866. DATES: Fax written comments on the sections 402 (21 U.S.C. 342) (regarding II. Paperwork Reduction Act of 1995 collection of information by March 28, adulteration) and 403(w) (21 U.S.C. 2019. This draft guidance refers to 343(w)) (if applicable) (regarding previously approved collections of ADDRESSES: To ensure that comments on misbranding with respect to labeling for information that are subject to review by the information collection are received, the presence of major food allergens) of the Office of Management and Budget OMB recommends that written the FD&C Act. The regulations also (OMB) under the Paperwork Reduction comments be faxed to the Office of provide for certain exemptions. Act of 1995 (44 U.S.C. 3501–3520). The Information and Regulatory Affairs, To assist respondents with OMB, Attn: FDA Desk Officer, Fax: 202– understanding the regulatory collections of information in part 314 _ (21 CFR part 314), including §§ 314.50 395–7285, or emailed to oira requirements, we have developed and 314.94, have been approved under [email protected]. All Agency guidance, which is available at: OMB control number 0910–0001. The comments should be identified with the https://www.fda.gov/Food/Guidance collections of information in part 312 OMB control number 0910–0752. Also Regulation/FSMA/ucm253380.htm. (21 CFR part 312), including § 312.23, include the FDA docket number found In the Federal Register of October 22, have been approved under OMB control in brackets in the heading of this 2018 (83 FR 53271), we published a 60- number 0910–0014. The collection of document. day notice requesting public comment information in 21 CFR parts 50 and 56 FOR FURTHER INFORMATION CONTACT: on the proposed collection of have been approved under OMB control JonnaLynn Capezzuto, Office of information. No comments were numbers 0910–0755 and 0910–0130. Operations, Food and Drug received. The collections of information in 21 Administration, Three White Flint We estimate the burden for the CFR 201.56 and 201.57 have been North, 10A–12M, 11601 Landsdown St., information collection as follows:

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 21 CFR section(s) Number of responses per Total annual Average burden Total hours respondents respondent responses per response

Exemption for food for research 1.501(c) ...... 36,360 40 1,454,400 0.083 (5 minutes) ... 120,715 DUNS number for filing with U.S. Customs and Bor- 56,800 157 8,917,600 0.02 (1.2 minutes) .. 178,352 der Protection 1.509, 1.511, 1.512.

Total ...... 299,067 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Information collection activity; 21 CFR section(s) Number of records per Total annual Average burden Total hours recordkeepers recordkeeper records per recordkeeping

Controls for low-acid canned foods; 1.502(b) ...... 2,443 4 9,772 1 ...... 9,772 FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and corrective actions: Determine and document hazards; 1.504(a) ...... 11,701 1 11,701 3.5 ...... 40,954 Review hazard analysis; 1.504(d) ...... 11,701 7 81,907 0.33 (20 minutes) ... 27,029 Evaluation of food and foreign supplier; 11,701 1 11,701 4...... 46,804 1.505(a)(2), 1.511(c)(1). Approval of suppliers; 1.505(b), 1.512(c)(1)(iii) ... 8,191 1 8,191 12 ...... 928,292 Reevaluation of food and foreign supplier; 11,701 365 4,270,865 0.25 (15 minutes) ... 1,067,716 1.505(c), 1.512(c)(1)(ii)(A). Confirm or change requirements of foreign sup- 2,340 1 2,340 2...... 4,680 plier verification activity; 1.505(c), 1.512(c)(1)(ii)(A). Review of other entities assessments; 1.505(d), 3,510 1 3,510 1.2...... 4,212 1.512(c)(1)(iii). Written procedures for use of approved foreign 11,701 1 11,701 8...... 93,608 suppliers; 1.506(a)(1), 1.511(c)(2), 1.512(c)(3)(i). Review of written procedures; 1.506(a)(2), 11,701 1 11,701 1...... 11,701 1.511(c)(2)(ii), 1.512(c)(3)(ii). Written procedures for conducting verification ac- 11,701 1 11,701 2...... 23,402 tivities; 1.506(b), 1.511(c)(3). Determination and documentation of appropriate 11,701 4 46,804 3.25...... 152,113 supplier verification activities; 1.506(d)(1)–(2) 1.511(c)(5)(i). Review of appropriate supplier verification activi- 11,701 2 23,402 0.33 (20 minutes) .. 7,723 ties determined by another entity; 1.506(d)(3) 1.511(c)(5)(iii). Conduct/review audits; 1.506(e)(1)(i), 11,701 2 23,402 3...... 70,206 1.511(c)(4)(ii)(A). Conduct periodic sampling/testing; 11,701 2 23,402 1...... 23,402 1.506(e)(1)(ii), 1.511(c)(4)(ii)(B). Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C) 11,701 2 23,402 1.6 ...... 37,443 Document your review of supplier verification ac- 11,701 6 70,206 0.25 (15 minutes) .. 17,552 tivity records; 1.506(e)(3), 1.511(c)(4)(iii). Document hazard controls; 1.507(a)(1) ...... 11,701 3.17 37,092 1.25 ...... 46,365 Written assurances; 1.507(a)(2), (a)(3), and 11,701 8.72 102,038 0.50 (30 minutes) ... 51,019 (a)(4). Disclosures that accompany assurances; 102,038 1 102,038 0.50 (30 minutes) .. 51,019 1.507(a)(2), (a)(3), and (a)(4). Document assurances from customers; 1.507(c) 36,522 2.8 102,262 0.25 (15 minutes) .. 25,566 Document corrective actions; 1.508(a), 2,340 1 2,340 2...... 4,680 1.512(b)(4). Investigate and determine FSVP adequacy; 2,340 1 2,340 5...... 11,700 1.508(b), 1.511(c)(1).

Subtotal for FSVP Recordkeeping Itemized ...... 4,984,046 ...... 1,917,186 Above. Written assurances for food produced under die- 11,701 2.88 33,699 2.25...... 75,823 tary supplement current good manufacturing practices; 1.511(b). Document very small importer/certain small for- 50,450 1 50,450 1...... 50,450 eign supplier status; 1.512(b)(1). Written assurances associated with very small 50,450 2.8 141,260 2.25...... 317,835 importer/certain small foreign supplier 1.512(b)(3).

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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Number of Information collection activity; 21 CFR section(s) Number of records per Total annual Average burden Total hours recordkeepers recordkeeper records per recordkeeping

Total ...... 2,361,294 1 There are no capital costs or operating and maintenance costs associated with the information collection.

We are retaining the currently FOR FURTHER INFORMATION CONTACT: Mr. an active lifestyle. Activities and approved burden estimates. The FSVP Anthony Welch, HHS Office of Minority materials throughout the month will requirements became effective May 30, Health Quality, 1101 Wootton Parkway, highlight the overall message that 2017, and we continue to evaluate Suite 600, Tower Building, Rockville, physical activity promotes health and associated burden. Maryland 20852; (240) 453–2882. reduces the risk of chronic disease. Dated: February 21, 2019. SUPPLEMENTARY INFORMATION: The Eligibility for Co-Sponsorship Lowell J. Schiller, mission of the Office of Minority Health To be eligible, a potential co-sponsor Acting Associate Commissioner for Policy. (OMH) at the U.S. Department of Health and Human Services (HHS) is to shall: (1) Have a demonstrated [FR Doc. 2019–03282 Filed 2–25–19; 8:45 am] improve the health of racial and ethnic understanding, commitment, and BILLING CODE 4164–01–P minority populations through the experience in conducting large-scale development of health policies and steps challenges; (2) be knowledgeable programs that will help eliminate health about strategies to promote health & DEPARTMENT OF HEALTH AND active lifestyles; (3) have a track record HUMAN SERVICES disparities. Key strategies of the OMH mission include: and the ability to manage an online • Notice of Opportunity To Co-Sponsor Developing and promoting policies, platform to host multiple teams in the OMH National Minority Health Month programs and practices to achieve challenge; (4) participate substantively Steps Challenge health equity; in the co-sponsored activity, not just • Funding demonstration programs at provide logistical support; and (5) have AGENCY: Office of the Secretary, Office the regional, state and local level that an organizational mission that is of the Assistant Secretary for Health, can contribute to health policy and the consistent with OMH and HHS. The Office of Minority Health (OMH), effectiveness of strategies for improving selected co-sponsoring organization Department of Health and Human health; shall furnish the necessary personnel, Services. • Improving data collection, reporting materials, services, and facilities to administer its proposed portion of the ACTION: Notice. and sharing for ethnic and racial minority populations; responsibility for the Challenge. These • SUMMARY: OMH announces the Fostering research and evaluation; duties will be outlined in a co- opportunity for public and non-profit and sponsorship agreement with OMH that • entities to co-sponsor the National Establishing and strengthening will set forth the details of the co- Minority Health Month National Steps networks, coalitions and partnerships to sponsored activity. identify and solve health problems. Challenge for April 2019. Potential co- Co-Sponsorship Proposal sponsors must have a demonstrated OMH observes National Minority interest in reducing health disparities Health Month every year in April to Each co-sponsorship proposal shall among minority communities, highlight the health disparities that contain a description of: (1) The entity advancing the HHS Physical Activity persist among racial and ethnic minority or organization’s background and Guidelines and improving the health of populations and the ways in which history; (2) its ability to satisfy the co- Americans through promoting regular policies, programs and partnerships can sponsorship criteria detailed above; and physical activity. help advance health equity. The HHS (3) its proposed involvement in the co- OMH establishes the national theme and sponsored activity. The co-sponsorship DATES: To receive consideration for this serves as the lead HHS office for the proposal should not exceed two (2) opportunity, a two-page proposal to observance of National Minority Health pages in length and should be double- participate as a co-sponsor must be Month. spaced in Times New Roman. received by OMH by 5 p.m. EST on The theme for 2019 is Active & March 7, 2019 at the address listed Healthy and is intended to help promote Evaluation Criteria below. Co-sponsorship proposals will the second edition of the HHS Physical After engaging in exploratory meet the deadline if they are either (1) Activity Guidelines and the Move Your discussions with potential co-sponsors received or (2) postmarked on or before Way Campaign from the HHS Office of that respond to this notice, the deadline. Privately metered Disease Prevention and Health representatives of OMH will select the postmarks will not be accepted as proof Promotion, especially among racial and co-sponsor using the following of timely mailing. Proposals received ethnic minorities. OMH’s main activity evaluation criteria: after the established deadline will not for this year’s observance is the National (1) Qualifications and capability to be considered. Minority Health Month Steps Challenge fulfill co-sponsorship responsibilities; ADDRESSES: Proposals for co- (Challenge). The Challenge will occur (2) Creativity related to enhancing the sponsorship should be sent to Mr. throughout the month of April and National Minority Health Month event; Anthony Welch, HHS Office of Minority OMH will enlist teams and individuals (3) Potential for reaching and Health, 1101 Wootton Parkway, Suite to participate from federal, state and generating participants from among key 600, Tower Building, Rockville, local governments, community-based stakeholders, including federal, state Maryland 20852. Requests may also be organizations and tribal communities, and local organizations, member-based emailed to [email protected]. who want to show their commitment to organizations and the general public.

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(4) Experience operating steps Career Development Awards for Scientists Branch, U.S. Customs and Border challenges; and Clinicians; 93.272, Alcohol National Protection, Office of Trade, Regulations (5) Past or current work specific to Research Service Awards for Research and Rulings, 90 K Street NE, 10th Floor, health equity and physical activity Training; 93.273, Alcohol Research Programs; Washington, DC 20229–1177, promotion; 93.891, Alcohol Research Center Grants; Telephone number (202) 325–0056 or (6) Professional qualifications and 93.701, ARRA Related Biomedical Research _ and Research Support Awards., National via email CBP [email protected]. Please specific expertise with promoting Institutes of Health, HHS) note that the contact information physical activity; provided here is solely for questions (7) Availability and description of Dated: February 20, 2019. regarding this notice. Individuals online platform to support the Melanie J. Pantoja, seeking information about other CBP challenge; and Program Analyst, Office of Federal Advisory programs should contact the CBP (8) Proposed plan for managing the Committee Policy. National Customer Service Center at co-sponsorship with OMH. [FR Doc. 2019–03207 Filed 2–25–19; 8:45 am] 877–227–5511, (TTY) 1–800–877–8339, Dated: February 15, 2019. BILLING CODE 4140–01–P or CBP website at https://www.cbp. Felicia Collins, gov/. Capt., Deputy Assistant Secretary for Minority SUPPLEMENTARY INFORMATION: CBP Health, (HHS Office of Minority Health). DEPARTMENT OF HOMELAND invites the general public and other [FR Doc. 2019–03296 Filed 2–25–19; 8:45 am] SECURITY Federal agencies to comment on the BILLING CODE 4150–29–P proposed and/or continuing information U.S. Customs and Border Protection collections pursuant to the Paperwork [1651–0032] Reduction Act of 1995 (44 U.S.C. 3501 DEPARTMENT OF HEALTH AND et seq.). This process is conducted in HUMAN SERVICES Agency Information Collection accordance with 5 CFR 1320.8. Written Activities: Importers of Merchandise comments and suggestions from the National Institutes of Health Subject to Actual Use Provisions public and affected agencies should address one or more of the following National Institute on Alcohol Abuse AGENCY: U.S. Customs and Border four points: (1) Whether the proposed and Alcoholism; Notice of Closed Protection (CBP), Department of collection of information is necessary Meeting Homeland Security. for the proper performance of the Pursuant to section 10(d) of the ACTION: 60-Day notice and request for functions of the agency, including Federal Advisory Committee Act, as comments; extension of an existing whether the information will have amended, notice is hereby given of a collection of information. practical utility; (2) the accuracy of the meeting of the Board of Scientific agency’s estimate of the burden of the SUMMARY: The Department of Homeland Counselors, National Institute on proposed collection of information, Security, U.S. Customs and Border Alcohol Abuse and Alcoholism. including the validity of the The meeting will be closed to the Protection will be submitting the methodology and assumptions used; (3) public as indicated below in accordance following information collection request suggestions to enhance the quality, with the provisions set forth in section to the Office of Management and Budget utility, and clarity of the information to 552b(c)(6), Title 5 U.S.C., as amended (OMB) for review and approval in be collected; and (4) suggestions to for the review, discussion, and accordance with the Paperwork minimize the burden of the collection of evaluation of individual intramural Reduction Act of 1995 (PRA). The information on those who are to programs and projects conducted by the information collection is published in respond, including through the use of NATIONAL INSTITUTE ON ALCOHOL the Federal Register to obtain comments appropriate automated, electronic, ABUSE AND ALCOHOLISM, including from the public and affected agencies. mechanical, or other technological consideration of personnel DATES: Comments are encouraged and collection techniques or other forms of qualifications and performance, and the must be submitted (no later than April information technology, e.g., permitting competence of individual investigators, 29, 2019) to be assured of consideration. electronic submission of responses. The the disclosure of which would ADDRESSES: Written comments and/or comments that are submitted will be constitute a clearly unwarranted suggestions regarding the item(s) summarized and included in the request invasion of personal privacy. contained in this notice must include for approval. All comments will become a matter of public record. Name of Committee: Board of Scientific the OMB Control Number 1651–0032 in Counselors, National Institute on Alcohol the subject line and the agency name. Overview of This Information Abuse and Alcoholism. To avoid duplicate submissions, please Collection Date: September 18, 2019. use only one of the following methods Time: 8:30 a.m. to 3:30 p.m. to submit comments: Title: Importers of Merchandise Agenda: To review and evaluate personal (1) Email. Submit comments to: CBP_ Subject to Actual Use Provisions. OMB Number: 1651–0032. qualifications and performance, and [email protected]. competence of individual investigators. Current Actions: CBP proposes to Place: National Institutes of Health, (2) Mail. Submit written comments to extend the expiration date of this Building 10, Conference Room I–2330, 10 CBP Paperwork Reduction Act Officer, information collection with no change Center Drive, Bethesda, MD 20892. U.S. Customs and Border Protection, to the burden hours or to the Contact Person: George Kunos, M.D., Ph.D., Office of Trade, Regulations and information collected. Scientific Director, Office of the Scientific Rulings, Economic Impact Analysis Director, National Institute on Alcohol Abuse Type of Review: Extension (without Branch, 90 K Street NE, 10th Floor, change). and Alcoholism, National Institutes of Washington, DC 20229–1177. Health, 5625 Fishers Lane, Room 2S–24A, Affected Public: Businesses. Rockville, MD 20852, 301–443–2069, FOR FURTHER INFORMATION CONTACT: Abstract: In accordance with 19 CFR [email protected]. Requests for additional PRA information 10.137, importers of goods subject to the (Catalogue of Federal Domestic Assistance should be directed to Seth Renkema, actual use provisions of the Harmonized Program Nos. 93.271, Alcohol Research Chief, Economic Impact Analysis Tariff Schedule of the United States

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(HTSUS) are required to maintain (1) Email. Submit comments to: CBP_ Overview of This Information detailed records to establish that these [email protected]. Collection goods were actually used as (2) Mail. Submit written comments to Title: Holders or Containers Which contemplated by the law, and to support CBP Paperwork Reduction Act Officer, Enter the United States Duty Free. the importer’s claim for a free or U.S. Customs and Border Protection, OMB Number: 1651–0035. reduced rate of duty. The importer shall Office of Trade, Regulations and Current Action: CBP proposes to maintain records of use or disposition extend the expiration date of this for a period of three years from the date Rulings, Economic Impact Analysis Branch, 90 K Street NE, 10th Floor, information collection with no change of liquidation of the entry, and the to the burden hours or to the Washington, DC 20229–1177. records shall be available at all times for information collected. examination by CBP. FOR FURTHER INFORMATION CONTACT: Type of Review: Extension (with no Estimated Number of Respondents: Requests for additional PRA information change). 12,000. should be directed to Seth Renkema, Affected Public: Businesses. Estimated Number of Responses per Chief, Economic Impact Analysis Abstract: Items 9801.00.10 and Respondent: 1. Branch, U.S. Customs and Border 9803.00.50 under the Harmonized Tariff Estimated Number of Total Annual Schedules of the United States Protection, Office of Trade, Regulations Responses: 12,000. (HTSUS), codified as 19 U.S.C. 1202, and Rulings, 90 K Street NE, 10th Floor, Estimated Time per Response: 65 provides for the duty-free entry of minutes. Washington, DC 20229–1177, substantial holders or containers of Estimated Total Annual Burden Telephone number (202) 325–0056 or _ foreign manufacture if duty had been Hours: 13,000. via email CBP [email protected]. Please paid upon a previous importation Dated: February 20, 2019. note that the contact information pursuant to the provisions of 19 CFR Seth D. Renkema, provided here is solely for questions 10.41b. Branch Chief, Economic Impact Analysis regarding this notice. Individuals 19 CFR 10.41b provides that Branch, U.S. Customs and Border Protection. seeking information about other CBP substantial holders or containers are to [FR Doc. 2019–03211 Filed 2–25–19; 8:45 am] programs should contact the CBP have prescribed markings in clear and BILLING CODE 9111–14–P National Customer Service Center at conspicuous letters of such a size that 877–227–5511, (TTY) 1–800–877–8339, they will be easily discernable. Section or CBP website at https://www.cbp.gov/ 10.41b of the CBP regulations eliminates DEPARTMENT OF HOMELAND . the need for an importer to file entry SECURITY documents by instead requiring the SUPPLEMENTARY INFORMATION: CBP marking of the containers or holders to U.S. Customs and Border Protection invites the general public and other indicate the HTSUS numbers that Federal agencies to comment on the [1651–0035] provide for duty free treatment of the proposed and/or continuing information containers or holders. Agency Information Collection collections pursuant to the Paperwork In order to comply with 19 CFR Activities: Holders or Containers Reduction Act of 1995 (44 U.S.C. 3501 10.41b in the case of serially numbered Which Enter the United States Duty et seq.). This process is conducted in holders or containers of United States Free accordance with 5 CFR 1320.8. Written manufacture for which free clearance comments and suggestions from the under 9801.00.10 HTSUS is claimed, AGENCY: U.S. Customs and Border public and affected agencies should the owner of the holder or container is Protection (CBP), Department of address one or more of the following required to place the markings on a Homeland Security. four points: (1) Whether the proposed metal tag or plate containing the ACTION: 60-Day notice and request for collection of information is necessary following information: 9801.00.10, comments; extension of an existing HTSUS; the name of the owner; and the collection of information. for the proper performance of the functions of the agency, including serial number assigned by the owner. In SUMMARY: The Department of Homeland whether the information will have the case of serially numbered holders or Security, U.S. Customs and Border practical utility; (2) the accuracy of the containers of foreign manufacture for Protection will be submitting the agency’s estimate of the burden of the which free clearance under 9803.00.50 HTSUS is claimed, the owner must following information collection request proposed collection of information, place markings containing the following to the Office of Management and Budget including the validity of the information: 9803.00.50 HTSUS; the (OMB) for review and approval in methodology and assumptions used; (3) accordance with the Paperwork port code numbers of the port of entry; suggestions to enhance the quality, the entry number; the last two digits of Reduction Act of 1995 (PRA). The utility, and clarity of the information to information collection is published in the fiscal year of entry covering the be collected; and (4) suggestions to importation of the holders and the Federal Register to obtain comments minimize the burden of the collection of from the public and affected agencies. containers on which duty was paid; the information on those who are to name of the owner; and the serial DATES: Comments are encouraged and respond, including through the use of number assigned by the owner. must be submitted (no later than April appropriate automated, electronic, Estimated Number of Respondents: 29, 2019) to be assured of consideration. mechanical, or other technological 20. ADDRESSES: Written comments and/or collection techniques or other forms of Estimated Number of Responses per suggestions regarding the item(s) information technology, e.g., permitting Respondent: 18. contained in this notice must include electronic submission of responses. The Estimated Number of Total Annual the OMB Control Number 1651–0035 in comments that are submitted will be Responses: 360. the subject line and the agency name. summarized and included in the request Estimated Time per Response: 15 To avoid duplicate submissions, please for approval. All comments will become minutes. use only one of the following methods Estimated Total Annual Burden to submit comments: a matter of public record. Hours: 90.

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Dated: February 20, 2019. A Federal Register notice with a 60- (7) major bibliographic references; and Seth D. Renkema, day public comment period soliciting (8) name, organization, address, phone Branch Chief, Economic Impact Analysis comments on this collection of number, and email of the person Branch, U.S. Customs and Border Protection. information was published on completing the form. [FR Doc. 2019–03210 Filed 2–25–19; 8:45 am] November 23, 2018 (83 FR 59413). No Title of Collection: National Historic BILLING CODE 9111–14–P comments were received. Landmarks Nomination Form. We are again soliciting comments on OMB Control Number: 1024–0276. the proposed IC that is described below. Form Number: NPS Form 10–934. We are especially interested in public Type of Review: Extension of a DEPARTMENT OF THE INTERIOR comment addressing the following currently approved collection. Respondents/Affected Public: Private National Park Service issues: (1) Is the collection necessary to the proper functions of the NPS, (2) will individuals; state, tribal and local [NPS–WASO–CR–NR–NHL PPWOCRADI0, this information be processed and used governments; businesses; educational PCU00RP14.50000; OMB Control Number in a timely manner; (3) is the estimate institutions; and nonprofit 1024–0276] of burden accurate; (4) how might the organizations. NPS enhance the quality, utility, and Total Estimated Number of Annual Agency Information Collection clarity of the information to be Respondents: 50. Activities; National Historic Landmarks collected; and (5) how might the NPS Total Estimated Number of Annual Nomination Form minimize the burden of this collection Responses: 50. Estimated Completion Time per AGENCY: National Park Service, Interior. on the respondents, including through the use of information technology. Response: Varies from 256 hours to 603 ACTION: Notice of information collection Comments that you submit in hours, depending on respondent and/or request; request for comment. response to this notice are a matter of activity. Total Estimated Number of Annual SUMMARY: In accordance with the public record. Before including your Burden Hours: 10,360. Paperwork Reduction Act of 1995, we, address, phone number, email address, Respondent’s Obligation: Required to the National Park Service (NPS) are or other personal identifying information in your comment, you obtain or retain benefits. proposing to renew an information Frequency of Collection: On occasion. collection. should be aware that your entire comment—including your personal Total Estimated Annual Nonhour DATES: Interested persons are invited to identifying information—may be made Burden Cost: None. submit comments on or before March publicly available at any time. While An agency may not conduct or 28, 2019. you can ask us in your comment to sponsor and a person is not required to ADDRESSES: Send written comments on withhold your personal identifying respond to a collection of information this information collection (IC) to the information from public review, we unless it displays a currently valid OMB Office of Management and Budget’s cannot guarantee that we will be able to control number. Desk Officer for the Department of the do so. The authority for this action is the Interior by email at OIRA_Submission@ Abstract: The NPS is authorized by Paperwork Reduction Act of 1995 (44 omb.eop.gov; or via facsimile to (202) Historic Sites Act of 1935 (54 U.S.C. U.S.C. 3501 et seq.). 395–5806. Please provide a copy of your 320101 et seq.); 36 CFR part 65; the Phadrea D. Ponds, National Historic Preservation Act of comments to Phadrea D. Ponds, Acting NPS Information Collection Clearance Information Collection Clearance 1966 (54 U.S.C. 300101 et seq.) to Officer, National Park Service. Officer, National Park Service, 1201 collect this information on behalf of the Secretary of the Interior. In accordance [FR Doc. 2019–03226 Filed 2–25–19; 8:45 am] Oakridge Drive, Fort Collins, CO 80525; BILLING CODE 4312–52–P or by email to [email protected]. with the law and 36 CFR part 65, private Please reference OMB Control Number citizens, businesses, and organizations; Federal agencies (FPO); State and local 1024–0276 in the subject line of your DEPARTMENT OF THE INTERIOR comments. public agencies; State Historic Preservation Officers (SHPOs); National Park Service FOR FURTHER INFORMATION CONTACT: To territories; and Indian tribes (THPO) request additional information about may submit nominations for National [NPS–NRSS–BRD–FR00000039; this ICR, contact Patty Henry by email Historic Landmark (NHL) designation. PPWONRADB0PPMRSNR1Y.NM0000]; OMB _ at patty [email protected], or by telephone All interested parties must inquire by Control Number 1024–0275] at 202–354–2216. You may also view letter or email about the eligibility of Agency Information Collection the IC at http://www.reginfo.gov/public/ properties to be considered for NHL do/PRAMain. Activities; Using Web and Mobile- designation. The inquiry will include Based Applications During NPS Citizen SUPPLEMENTARY INFORMATION: In the name, location, brief description and Science Events accordance with the Paperwork historical summary of property. Reduction Act of 1995, we provide the If determined eligible for AGENCY: National Park Service, Interior. general public and other Federal consideration the respondent will use ACTION: Notice of Information Collection agencies with an opportunity to NPS Form 10–934 (National Historic Request; request for comment. comment on new, proposed, revised, Landmarks Nomination Form) to and continuing collections of nominate a property. The form is used SUMMARY: In accordance with the information. This helps us assess the to collect the following information Paperwork Reduction Act of 1995, we, impact of our information collection related to the property: (1) Name and the National Park Service (NPS) are requirements and minimize the public’s location (2) significance data; (3) any proposing to renew an information reporting burden. It also helps the withholding of sensitive information; (4) collection with revisions. public understand our information geographical data; (5) significance DATES: Interested persons are invited to collection requirements and provide the statements and discussions (6) submit comments on or before March requested data in the desired format. description and statement of integrity; 28, 2019.

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ADDRESSES: Send written comments on comment, you should be aware that INTERNATIONAL TRADE this information collection request (ICR) your entire comment—including your COMMISSION to the Office of Management and personal identifying information—may [Investigation No. 337–TA–1087] Budget’s Desk Officer for the be made publicly available at any time. Department of the Interior by email at While you can ask us in your comment Certain Batteries and Electrochemical _ OIRA [email protected]; or via to withhold your personal identifying Devices Containing Composite facsimile to (202) 395–5806. Please information from public review, we Separators, Components Thereof, and provide a copy of your comments to cannot guarantee that we will be able to Products Containing Same; Phadrea D. Ponds, Information do so. Commission Determination Not To Abstract: The NPS is authorized by Collection Clearance Officer, National Review an Initial Determination the National Park Service Protection Park Service, 1201 Oakridge Drive, Fort Granting a Joint Motion To Terminate Interpretation and research in System Collins, CO 80525; or by email to the Investigation Based Upon _ (54 U.S.C. 100701) to collect this phadrea [email protected]. Please Settlement; Termination of the information. The NPS is requesting reference Information Collection Investigation Request 1024–0275 in the subject line. approval to use mobile and web-based FOR FURTHER INFORMATION CONTACT: To applications (e.g., iNaturalist, eBird, etc) AGENCY: U.S. International Trade request additional information about as a means to collect natural history Commission. this IC, contact Kriston Barnes, Natural observational information from park ACTION: Notice. Resource Stewardship and Science visitors during citizen science events. Directorate, National Park Service, 1201 The information will be used to SUMMARY: Notice is hereby given that Oakridge Dr. Suite 200 Fort Collins, CO substantiate the occurrence of plant, the U.S. International Trade 80525 (mail); [email protected] wildlife and invertebrate species within Commission has determined not to NPS units during these events. By using (email); or: 970–658–6013 (phone). You review an initial determination (‘‘ID’’) citizen science applications, this may also view the IC at http:// (Order No. 42) of the presiding information will be immediately www.reginfo.gov/public/do/PRAMain. administrative law judge (‘‘ALJ’’) available to all parks and others granting a joint motion to terminate the SUPPLEMENTARY INFORMATION: In interested in species identification and investigation based upon settlement. accordance with the Paperwork advancing the knowledge of the natural The investigation is terminated. Reduction Act of 1995, we provide the world. Using mobile and web-based FOR FURTHER INFORMATION CONTACT: general public and other Federal applications will enable parks to agencies with an opportunity to Houda Morad, Office of the General increase the number of natural history Counsel, U.S. International Trade comment on new, proposed, revised, observation records that will contribute and continuing collections of Commission, 500 E Street SW, to greater understanding of the Washington, DC 20436, telephone (202) information. This helps us assess the biodiversity within the park systems. impact of our information collection 708–4716. Copies of non-confidential Title of Collection: Using web and documents filed in connection with this requirements and minimize the public’s mobile-based applications during NPS reporting burden. It also helps the investigation are or will be available for Citizen Science events. inspection during official business public understand our information OMB Control Number: 1024–0275. collection requirements and provide the Form Number: None. hours (8:45 a.m. to 5:15 p.m.) in the requested data in the desired format. Type of Review: Revision of a Office of the Secretary, U.S. A Federal Register notice with a 60- currently approved collection. International Trade Commission, 500 E day public comment period soliciting Respondents/Affected Public: General Street SW, Washington, DC 20436, comments on this collection of public, individual households, and non- telephone (202) 205–2000. General information was published on federal scientists. information concerning the Commission November 23rd, 2018. (83 FR 59413). Total Estimated Number of Annual may also be obtained by accessing its No comments were received. Respondents: 7,500. internet server at https://www.usitc.gov. We are soliciting comments on the Total Estimated Number of Annual The public record for this investigation proposed ICR that is described below. Responses: 112,500. may be viewed on the Commission’s We are especially interested in public Estimated Completion Time per electronic docket (EDIS) at https:// comment addressing the following Response: 5 minutes. edis.usitc.gov. Hearing-impaired issues: (1) Is the collection necessary to Total Estimated Number of Annual persons are advised that information on the proper functions of the NPS; (2) will Burden Hours: 9,375 hours. this matter can be obtained by this information be processed and used Respondent’s Obligation: Voluntary. contacting the Commission’s TDD in a timely manner; (3) is the estimate Frequency of Collection: One time. terminal on (202) 205–1810. Total Estimated Annual Nonhour of burden accurate; (4) how might the SUPPLEMENTARY INFORMATION: The Burden Cost: None. NPS enhance the quality, utility, and An agency may not conduct or Commission instituted this investigation clarity of the information to be sponsor and a person is not required to on November 28, 2017, based on a collected; and (5) how might the NPS respond to a collection of information complaint, as supplemented, filed by LG minimize the burden of this collection unless it displays a currently valid OMB Chem, Ltd. of South Korea; LG Chem on the respondents, including through control number. Michigan Inc. of Holland, Michigan; LG the use of information technology. The authority for this action is the Chem Power Inc. of Troy, Michigan; and Comments that you submit in Paperwork Reduction Act of 1995 (44 Toray Industries, Inc. of Japan. See 82 response to this notice are a matter of U.S.C. 3501 et seq). FR 56265 (Nov. 28, 2017). The public record. We will include or complaint alleges violations of section summarize each comment in our request Phadrea Ponds, 337 of the Tariff Act of 1930, as to OMB to approve this IC. Before Acting NPS Information Collection Clearance amended (19 U.S.C. 1337), based upon including your address, phone number, Officer, National Park Service. the importation into the United States, email address, or other personal [FR Doc. 2019–03225 Filed 2–25–19; 8:45 am] the sale for importation, and the sale identifying information in your BILLING CODE 4312–52–P within the United States after

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importation of certain batteries and DEPARTMENT OF JUSTICE e.g., permitting electronic submission of electrochemical devices containing responses. composite separators, components [OMB Number 1122–0021] (1) Type of Information Collection: thereof, and products containing same, Extension of a currently approved by reason of infringement of certain Agency Information Collection collection. claims of U.S. Patent No. 7,662,517; U.S. Activities; Proposed eCollection (2) Title of the Form/Collection: Semi- Patent No. 7,638,241; and U.S. Patent eComments Requested; Extension of a Annual Progress Report for Grantees Currently Approved Collection No. 7,709,152. See id. The notice of from Grants to Enhance Culturally and Linguistically Specific Services for investigation names Amperex AGENCY: Office on Violence Against Technology Limited of Hong Kong; DJI Women, Department of Justice. Victims of Domestic Violence, Dating Violence, Sexual Assault, and Stalking Technology Co., Ltd. of Shenzhen, ACTION: 30-Day notice. China; DJI Technology, Inc. of Burbank, Program (Culturally and Linguistically California; Guangdong OPPO Mobile, SUMMARY: The Department of Justice, Specific Services Program). Telecommunications Corp., Ltd. of Office on Violence Against Women (3) Agency form number, if any, and the applicable component of the Guangdong, China; and OPPO Digital, (OVW) will be submitting the following Department of Justice sponsoring the Inc. of Menlo Park, California, as information collection request to the collection: Form Number: 1122–0021. respondents in this investigation. See Office of Management and Budget (OMB) for review and approval in U.S. Department of Justice, Office on id. The Office of Unfair Import Violence Against Women. Investigations is not a party to this accordance with the Paperwork Reduction Act of 1995. (4) Affected public who will be asked investigation. See id. or required to respond, as well as a brief DATES: Comments are encouraged and On January 30, 2019, the parties filed abstract: The affected public includes will be accepted for 30 days until March a joint motion to terminate the the approximately 50 grantees of the 28, 2019. investigation based on settlement. On Culturally and Linguistically Specific February 4, 2019, the ALJ issued the FOR FURTHER INFORMATION CONTACT: Services Program. The program funds subject ID (Order No. 42) granting the Written comments and/or suggestion projects that promote the maintenance regarding the items contained in this joint motion. The ID finds that and replication of existing successful notice, especially the estimated public ‘‘[c]onsistent with Commission rule domestic violence, dating violence, burden and associated response time, 210.21(b), the parties have filed sexual assault, and stalking community- should be directed to Cathy Poston, based programs providing culturally confidential and public versions of the Office on Violence Against Women, at settlement agreement’’ and that ‘‘the and linguistically specific services and 202–514–5430 or Catherine.poston@ other resources. The program also parties state that ‘[t]here are no other usdoj.gov. Written comments and/or agreements, written or oral, express or supports the development of innovative suggestions can also be sent to the culturally and linguistically specific implied, between the parties concerning Office of Management and Budget, strategies and projects to enhance access the subject matter of the Investigation.’ ’’ Office of Information and Regulatory to services and resources for victims of See ID at 1–2 (citing 19 CFR Affairs, Attention Department of Justice violence against women. 210.2l(b)(1)). The ID also considers the Desk Officer, Washington, DC 20530 or _ (5) An estimate of the total number of public interest under Commission Rule sent to OIRA submissions@ respondents and the amount of time 210.50(b)(2), 19 CFR 210.50(b)(2), and omb.eop.gov. estimated for an average respondent to finds ‘‘no evidence . . . indicating that SUPPLEMENTARY INFORMATION: Written respond/reply: It is estimated that it will terminating this investigation on the comments and suggestions from the take the approximately 50 respondents basis of settlement would adversely public and affected agencies concerning (Culturally and Linguistically Specific affect the public health and welfare, the proposed collection of information Services Program grantees) competitive conditions in the United are encouraged. Your comments should approximately one hour to complete a States economy, the production of like address one or more of the following semi-annual progress report. The semi- or directly competitive articles in the four points: annual progress report is divided into United States, or United States (1) Evaluate whether the proposed sections that pertain to the different consumers.’’ See ID at 2. collection of information is necessary types of activities in which grantees No petition for review of the subject for the proper performance of the may engage. A Culturally and ID was filed. The Commission has functions of the agency, including Linguistically Specific Services Program determined not to review the ID. The whether the information will have grantee will only be required to investigation is terminated. practical utility; complete the sections of the form that (2) Evaluate the accuracy of the pertain to its own specific activities. The authority for the Commission’s agency’s estimate of the burden of the (6) An estimate of the total public determination is contained in section proposed collection of information, burden (in hours) associated with the 337 of the Tariff Act of 1930, as including the validity of the collection: The total annual hour burden amended (19 U.S.C. 1337), and in part methodology and assumptions used; to complete the data collection forms is 210 of the Commission’s Rules of (3) Enhance the quality, utility, and 100 hours, that is 50 grantees Practice and Procedure (19 CFR part clarity of the information to be completing a form twice a year with an 210). collected; and estimated completion time for the form By order of the Commission. (4) Minimize the burden of the being one hour. Issued: February 21, 2019. collection of information on those who If additional information is required are to respond, including through the contact: Melody Braswell, Deputy Lisa Barton, use of appropriate automated, Clearance Officer, United States Secretary to the Commission. electronic, mechanical, or other Department of Justice, Justice [FR Doc. 2019–03294 Filed 2–25–19; 8:45 am] technological collection techniques or Management Division, Policy and BILLING CODE 7020–02–P other forms of information technology, Planning Staff, Two Constitution

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Square, 145 N Street NE, 3E, 405B, proposed collection of information, subscriptions by making the sign-up Washington, DC 20530. including the validity of the process less cumbersome for users and Dated: February 21, 2019. methodology and assumptions used; collect meaningful customer —Enhance the quality, utility, and Melody Braswell, information to assist segmentation clarity of the information to be strategies for targeted outreach and Department Clearance Officer, PRA, U.S. Department of Justice. collected; and upselling of Bureau and Program Office —Minimize the burden of the collection products and services. [FR Doc. 2019–03305 Filed 2–25–19; 8:45 am] of information on those who are to BILLING CODE 4410–FX–P (5) An estimate of the total number of respond, including through the use of respondents and the amount of time appropriate automated, electronic, estimated for an average respondent to DEPARTMENT OF JUSTICE mechanical, or other technological respond/reply: An estimated 75 End collection techniques or other forms Users use the NCJRS online subscription [OMB Number 1121–NEW] of information technology, e.g., center on a monthly basis to register. permitting electronic submission of Based on pilot testing, an average of 2– Agency Information Collection responses. Activities; Proposed eCollection; 4 minutes per respondent is needed to eComments Requested Extension With Overview of This Information complete form 1121–NEW. The Change, of a Previously Approved Collection estimated range of burden for respondents is expected to be between Collection National Criminal Justice (1) Type of Information Collection: 2 minutes to 4 minutes for completion. Reference Service (NCJRS) Online Revision of a currently approved Subscription Center collection. (6) An estimate of the total public (2) Title of the Form/Collection: burden (in hours) associated with the AGENCY: Office of Justice Programs’ National Criminal Justice Reference collection: It is estimated that Office of Communications, Department Service (NCJRS) online subscription respondents will take 2–4 minutes to of Justice. center: https://www.ncjrs.gov/App/ complete their profile. The estimated ACTION: 30-Day notice. Secure/Registration/Register.aspx/. public burden hours associated for End (3) Agency form number, if any, and Users to subscribe is 5 hours per month SUMMARY: The Department of Justice × (DOJ), Office of Justice Programs (OJP), the applicable component of the (75 respondents 4 minutes = 300 Department sponsoring the collection: minutes/60 minutes = 5 hours) or 60 Office of Communications (OCOM) will × be submitting the following information Agency form number: 1121–NEW. hours per year (5 hours 12 months = collection request to the Office of Sponsoring component: Department 60 hours). Management and Budget (OMB) for of Justice, Office of Justice Programs, If additional information is required review and approval in accordance with Office of Communications. contact: Melody Braswell, Department (4) Affected public who will be asked the Paperwork Reduction Act of 1995. Clearance Officer, United States or required to respond, as well as a brief DATES: Comments are encouraged and Department of Justice, Justice abstract: Currently, constituents can Management Division, Policy and will be accepted for 30 days until March sign-up for communications, such as 28, 2019. Planning Staff, Two Constitution new publications, funding Square, 145 N Street NE, 3E.405A, FOR FURTHER INFORMATION CONTACT: opportunities, events, and other news Washington, DC 20530. Written comments and/or suggestions and announcements from NCJRS and regarding the items contained in this the NCJRS federal sponsors, place Dated: February 21, 2019. notice, especially the estimated public online orders, and track their order Melody Braswell, burden and associated response time, status by creating a detailed profile on Department Clearance Officer for PRA, U.S. should be directed to U.S. Department NCJRS.gov. End Users can also Department of Justice. of Justice, Office of Justice Programs, subscribe to specific Bureau, Program [FR Doc. 2019–03302 Filed 2–25–19; 8:45 am] Office of Communications, 810 Seventh Office, and shared email notification BILLING CODE 4410–FX–P Street NW, Washington, DC 20531. lists and newsletters when creating an Written comments and/or suggestions NCJRS account. This action can also be can also be sent to the Office of accomplished on various Bureau, DEPARTMENT OF JUSTICE Management and Budget, Office of Program Office, or GovDelivery web Information and Regulatory Affairs, pages. [OMB Number 1122–0028] Attention Department of Justice Desk However, the NCJRS online Officer, Washington, DC 20503 or sent subscription center is more than 14 Agency Information Collection _ to OIRA [email protected]. years old and subscription form Activities; Proposed eCollection SUPPLEMENTARY INFORMATION: Written selections have remained relatively eComments Requested; Extension of a comments and suggestions from the unchanged for more than 20 years. Currently Approved Collection public and affected agencies concerning Moreover, the subscription process the proposed collection of information includes 19 required fields and 7 AGENCY: Office on Violence Against are encouraged. Your comments should different screens, creating an undue Women, Department of Justice. address one or more of the following burden for End Users. ACTION: 30-Day Notice. four points: An evaluation of the current use of —Evaluate whether the proposed the information collected through the SUMMARY: The Department of Justice, collection of information is necessary form and its impact to End Users was Office on Violence Against Women for the proper performance of the conducted to see where updates can be (OVW) will be submitting the following functions of the agency, including made to make for a better user information collection request to the whether the information will have experience while enabling customer Office of Management and Budget practical utility; segmentation strategies for targeted (OMB) for review and approval in —Evaluate the accuracy of the agencies outreach. The goals for revising the accordance with the Paperwork estimate of the burden of the subscription process are to increase Reduction Act of 1995.

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DATES: Comments are encouraged and Consolidated Grant Program to Address Square, 145 N Street NE, 3E, 405B, will be accepted for 30 days until March Children and Youth Experiencing Washington, DC 20530. 28, 2019. Domestic and Sexual Assault and Dated: February 21, 2019. Engage Men and Boys as Allies FOR FURTHER INFORMATION CONTACT: Melody Braswell, Written comments and/or suggestions (hereafter referred to as the Consolidated Youth Program) enacted in Department Clearance Officer, PRA, U.S. regarding the items contained in this Department of Justice. the FY 2012–2018 appropriation acts, notice, especially the estimated public [FR Doc. 2019–03306 Filed 2–25–19; 8:45 am] burden and associated response time, which consolidated four previously BILLING CODE 4410–FX–P should be directed to Cathy Poston, authorized and appropriated programs Office on Violence Against Women, at into one comprehensive program. The four programs included in these 202–514–5430 or Catherine.poston@ DEPARTMENT OF JUSTICE usdoj.gov. Written comments and/or consolidations were: Services to suggestions can also be sent to the Advocate for and Respond to Youth [OMB Number 1122–0001] Office of Management and Budget, (Youth Services), Grants to Assist Office of Information and Regulatory Children and Youth Exposed to Agency Information Collection Affairs, Attention Department of Justice Violence (CEV), Engaging Men and Activities; Proposed eCollection Desk Officer, Washington, DC 20530 or Youth in Preventing Domestic Violence eComments Requested; Extension of a sent to OIRA_submissions@ (EMY), and Supporting Teens through Currently Approved Collection omb.eop.gov. Education and Prevention (STEP). The Consolidated Youth Program AGENCY: Office on Violence Against SUPPLEMENTARY INFORMATION: Written supports projects designed to provide Women, Department of Justice. comments and suggestions from the coordinated community responses that ACTION: 30-Day notice. public and affected agencies concerning support child, youth and young adult the proposed collection of information victims through direct services, training, SUMMARY: The Department of Justice, are encouraged. Your comments should coordination and collaboration, effective Office on Violence Against Women address one or more of the following intervention, treatment, response, and (OVW) will be submitting the following four points: prevention strategies. The Consolidated information collection request to the (1) Evaluate whether the proposed Youth Program creates a unique Office of Management and Budget collection of information is necessary opportunity for communities to increase (OMB) for review and approval in for the proper performance of the collaboration among non-profit victim accordance with the Paperwork functions of the agency, including service providers; violence prevention, Reduction Act of 1995. whether the information will have and children (0–10), youth (11–18), DATES: Comments are encouraged and practical utility; young adult (19–24) and men-serving will be accepted for 30 days until March (2) Evaluate the accuracy of the organizations; tribes and tribal 28, 2019. agency’s estimate of the burden of the governments; local government FOR FURTHER INFORMATION CONTACT: proposed collection of information, agencies; schools; and programs that Written comments and/or suggestion including the validity of the support men’s role in combating sexual regarding the items contained in this methodology and assumptions used; assault, domestic violence, dating notice, especially the estimated public (3) Enhance the quality, utility, and violence and stalking. burden and associated response time, clarity of the information to be (5) An estimate of the total number of should be directed to Cathy Poston, collected; and respondents and the amount of time Office on Violence Against Women, at (4) Minimize the burden of the estimated for an average respondent to 202–514–5430 or Catherine.poston@ collection of information on those who respond/reply: It is estimated that it will usdoj.gov. Written comments and/or are to respond, including through the take the approximately 25 respondents suggestions can also be sent to the use of appropriate automated, (grantees from the Consolidated Youth Office of Management and Budget, electronic, mechanical, or other Program) approximately one hour to Office of Information and Regulatory technological collection techniques or complete a semi-annual progress report. Affairs, Attention Department of Justice other forms of information technology, The semi-annual progress report is Desk Officer, Washington, DC 20530 or e.g., permitting electronic submission of divided into sections that pertain to the sent to OIRA_submissions@ responses. different types of activities in which omb.eop.gov. grantees may engage. A Consolidated Overview of This Information Youth Program grantee will only be SUPPLEMENTARY INFORMATION: Written Collection required to complete the sections of the comments and suggestions from the (1) Type of Information Collection: form that pertain to its own specific public and affected agencies concerning Extension of a Currently Approved activities. the proposed collection of information Collection. (6) An estimate of the total public are encouraged. Your comments should (2) Title of the Form/Collection: Semi- burden (in hours) associated with the address one or more of the following annual Progress Report for Children and collection: The total annual hour burden four points: Youth Exposed to Violence Program. to complete the data collection forms is (1) Evaluate whether the proposed (3) Agency form number, if any, and 50 hours, that is 25 grantees completing collection of information is necessary the applicable component of the a form twice a year with an estimated for the proper performance of the Department of Justice sponsoring the completion time for the form being one functions of the agency, including collection: Form Number: 1122–0028. hour. whether the information will have U.S. Department of Justice, Office on If additional information is required practical utility; Violence Against Women. contact: Melody Braswell, Deputy (2) Evaluate the accuracy of the (4) Affected public who will be asked Clearance Officer, United States agency’s estimate of the burden of the or required to respond, as well as a brief Department of Justice, Justice proposed collection of information, abstract: The affected public includes Management Division, Policy and including the validity of the the approximately 25 grantees under the Planning Staff, Two Constitution methodology and assumptions used;

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(3) Enhance the quality, utility, and Eligibility Requirements of the Violence address one or more of the following clarity of the information to be Against Women Act, as Amended. four points: collected; and (6) An estimate of the total public (1) Evaluate whether the proposed (4) Minimize the burden of the burden (in hours) associated with the collection of information is necessary collection of information on those who collection: The total annual hour burden for the proper performance of the are to respond, including through the to complete the Certification is less than functions of the agency, including use of appropriate automated, 56 hours. whether the information will have electronic, mechanical, or other If additional information is required practical utility; technological collection techniques or contact: Melody Braswell, Deputy (2) Evaluate the accuracy of the other forms of information technology, Clearance Officer, United States agency’s estimate of the burden of the e.g., permitting electronic submission of Department of Justice, Justice proposed collection of information, responses. Management Division, Policy and including the validity of the methodology and assumptions used; Overview of This Information Planning Staff, Two Constitution (3) Enhance the quality, utility, and Collection Square, 145 N Street NE, 3E, 405B, Washington, DC 20530. clarity of the information to be (1) Type of Information Collection: collected; and Extension of a currently approved Dated: February 21, 2019. (4) Minimize the burden of the collection. Melody Braswell, collection of information on those who (2) Title of the Form/Collection: Department Clearance Officer, PRA, U.S. are to respond, including through the Certification of Compliance with the Department of Justice. use of appropriate automated, Statutory Eligibility Requirements of the [FR Doc. 2019–03303 Filed 2–25–19; 8:45 am] electronic, mechanical, or other Violence Against Women Act as BILLING CODE 4410–FX–P technological collection techniques or Amended. other forms of information technology, (3) Agency form number, if any, and e.g., permitting electronic submission of the applicable component of the DEPARTMENT OF JUSTICE responses. Department of Justice sponsoring the collection: Form Number: 1122–0001. [OMB Number 1122–0022] Overview of This Information U.S. Department of Justice, Office on Collection Agency Information Collection Violence Against Women. Activities; Proposed eCollection (1) Type of Information Collection: (4) Affected public who will be asked Extension of a currently approved or required to respond, as well as a brief eComments Requested; Extension of a Currently Approved Collection collection. abstract: The affected public includes (2) Title of the Form/Collection: STOP formula grantees (50 states, the AGENCY: Office on Violence Against Annual Progress Report for the Sexual District of Columbia and five territories Women, Department of Justice. Assault Services Formula Grant Program (Guam, Puerto Rico, American Samoa, ACTION: 30-Day notice. (SASP). Virgin Islands, Northern Mariana (3) Agency form number, if any, and Islands). The STOP Violence Against SUMMARY: The Department of Justice, the applicable component of the Women Formula Grant Program was Office on Violence Against Women Department of Justice sponsoring the authorized through the Violence Against (OVW) will be submitting the following collection: Form Number: 1122–0022. Women Act of 1994 and reauthorized information collection request to the U.S. Department of Justice, Office on and amended in 2000, 2005, and 2013. Office of Management and Budget Violence Against Women. The purpose of the STOP Formula Grant (OMB) for review and approval in (4) Affected public who will be asked Program is to promote a coordinated, accordance with the Paperwork or required to respond, as well as a brief multi-disciplinary approach to Reduction Act of 1995. abstract: The affected public includes improving the criminal justice system’s DATES: Comments are encouraged and the approximately 606 administrators response to violence against women. It will be accepted for 30 days until March and subgrantees of the SASP. SASP envisions a partnership among law 28, 2019. grants support intervention, advocacy, enforcement, prosecution, courts, and accompaniment, support services, and FOR FURTHER INFORMATION CONTACT: victim advocacy organizations to related assistance for adult, youth, and Written comments and/or suggestion enhance victim safety and hold child victims of sexual assault, family regarding the items contained in this offenders accountable for their crimes of and household members of victims, and notice, especially the estimated public violence against women. The those collaterally affected by the sexual burden and associated response time, Department of Justice’s Office on assault. The SASP supports the should be directed to Cathy Poston, Violence Against Women (OVW) establishment, maintenance, and Office on Violence Against Women, at administers the STOP Formula Grant expansion of rape crisis centers and 202–514–5430 or Catherine.poston@ Program funds which must be other programs and projects to assist usdoj.gov. Written comments and/or distributed by STOP state those victimized by sexual assault. The suggestions can also be sent to the administrators according to statutory grant funds are distributed by SASP Office of Management and Budget, formula (as amended in 2000, 2005 and state administrators to subgrantees as Office of Information and Regulatory 2013). outlined under the provisions of the Affairs, Attention Department of Justice (5) An estimate of the total number of Violence Women Act. Desk Officer, Washington, DC 20530 or respondents and the amount of time _ (5) An estimate of the total number of estimated for an average respondent to sent to OIRA submissions@ respondents and the amount of time respond/reply: It is estimated that it will omb.eop.gov. estimated for an average respondent to take the approximately 56 respondents SUPPLEMENTARY INFORMATION: Written respond/reply: It is estimated that it will (state administrators from the STOP comments and suggestions from the take the approximately 606 respondents Formula Grant Program) less than one public and affected agencies concerning (SASP administrators and subgrantees) hour to complete a Certification of the proposed collection of information approximately one hour to complete an Compliance with the Statutory are encouraged. Your comments should annual progress report. The annual

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progress report is divided into sections Inc., D.J. Ref. No. 90–11–3–11525. All transaction restrictions of the Employee that pertain to the different types of comments must be submitted no later Retirement Income Security Act of 1974 activities in which subgrantees may than thirty (30) days after the (ERISA or the Act) and/or the Internal engage. A SASP subgrantee will only be publication date of this notice. Revenue Code of 1986 (the Code). The required to complete the sections of the Comments may be submitted either by exemption affects the ability of certain form that pertain to its own specific email or by mail: entities with specified relationships to activities. UBS, UBS Securities Japan, and UBS (6) An estimate of the total public To submit Send them to: France to continue to rely upon relief burden (in hours) associated with the comments: provided by Prohibited Transaction collection: The total annual hour burden Exemption 84–14. to complete the data collection form is By email ...... pubcomment-ees.enrd@ usdoj.gov. DATES: This exemption will be in effect 606 hours, that is 606 administrators By mail ...... Assistant Attorney General, for one year from the date of the and subgrantees completing a form once U.S. DOJ—ENRD, P.O. judgment in the French First Instance a year with an estimated completion Box 7611, Washington, DC Court against UBS and/or UBS France in time for the form being one hour. 20044–7611. case number 1105592033. If additional information is required FOR FURTHER INFORMATION CONTACT: contact: Melody Braswell, Deputy During the public comment period, Mr. Brian Mica of the Department at Clearance Officer, United States the Consent Decree may be examined (202) 693–8402. (This is not a toll-free Department of Justice, Justice and downloaded at this Justice number.) Management Division, Policy and Department website: https:// Planning Staff, Two Constitution www.justice.gov/enrd/consent-decrees. SUPPLEMENTARY INFORMATION: On Square, 145 N Street NE, 3E, 405B, We will provide a paper copy of the February 13, 2019, the Department Washington, DC 20530. Consent Decree upon written request published a notice of proposed Dated: February 21, 2019. and payment of reproduction costs. exemption in the Federal Register at 84 Melody Braswell, Please mail your request and payment FR 3818, for certain entities with specified relationships to UBS to Department Clearance Officer, PRA, U.S. to: Consent Decree Library, U.S. DOJ— Department of Justice. ENRD, P.O. Box 7611, Washington, DC continue to rely upon the relief provided by PTE 84–14 for a period of [FR Doc. 2019–03304 Filed 2–25–19; 8:45 am] 20044–7611. one year,1 notwithstanding certain BILLING CODE 4410–FX–P Please enclose a check or money order for $9.50 (25 cents per page criminal convictions, as described reproduction cost), payable to the herein (the Convictions) and the 2019 DEPARTMENT OF JUSTICE United States Treasury. French Judgment Against UBS/UBS France. Notice of Lodging of Proposed Robert Maher, The Department is granting this Consent Decree Under the Assistant Section Chief, Environmental exemption to ensure that Covered Comprehensive Environmental Enforcement Section, Environment & Natural Plans 2 with assets managed by an asset Response, Compensation, and Liability Resources Division. manager within the corporate family of Act [FR Doc. 2019–03276 Filed 2–25–19; 8:45 am] UBS may continue to benefit from the BILLING CODE 4410–15–P relief provided by PTE 84–14. This On February 13, 2019, the Department exemption will be in effect for one year of Justice lodged a proposed Consent from the date of the judgment in the Decree (‘‘Consent Decree’’) with the DEPARTMENT OF LABOR French First Instance Court against UBS United States District Court for the and/or UBS France. No inference should Western District of New York in the Employee Benefits Security be drawn from the Department’s lawsuit entitled United States v. Administration granting of this one-year exemption that Hillcrest Industries, Inc., Civil Action the Department will grant additional No. 1:18–cv–99. In the filed Complaint, [Prohibited Transaction Exemption 2019– 01; Exemption Application No. D–11988] relief for UBS QPAMs to continue to the United States, on behalf of the U.S. rely on the relief in PTE 84–14 Environmental Protection Agency Exemption Involving UBS Assets following the end of the one-year (‘‘EPA’’), alleges that Hillcrest Management (Americas) Inc.; UBS period. Industries, Inc. (‘‘Hillcrest’’) is liable Realty Investors LLC; UBS Hedge No relief from a violation of any other under the Comprehensive Fund Solutions LLC; UBS O’Connor law is provided by this exemption, Environmental Response, LLC; and Certain Future Affiliates in including any criminal convictions or Compensation, and Liability Act, 42 UBS’s Asset Management and Global U.S.C. 9607(a), for the response costs Wealth Management U.S. Divisions 1 49 FR 9494, March 13, 1984, as corrected at 50 EPA incurred to respond to the releases (Collectively, the Applicants or the FR 41430 (October 10, 1985), as amended at 70 FR and/or threatened releases of hazardous UBS QPAMs) Located in Chicago, 49305 (August 23, 2005) and as amended at 75 FR substances into the environment from a 38837 (July 6, 2010), hereinafter referred to as PTE Illinois; Hartford, Connecticut; New 84–14 or the QPAM exemption. parcel of property Hillcrest owns and York, New York; and Chicago, Illinois, 2 ‘‘Covered Plan’’ is a plan subject to Part 4 of operates. The Consent Decree requires Respectively Title 1 of ERISA (‘‘ERISA-covered plan’’) or a plan Hillcrest to pay $350,000 in quarterly subject to section 4975 of the Code (‘‘IRA’’) with installment payments of $20,000 each. AGENCY: Employee Benefits Security respect to which a UBS QPAM relies on PTE 84– 14, or with respect to which a UBS QPAM (or any The publication of this notice opens Administration, Labor. UBS affiliate) has expressly represented that the a period for public comment on the ACTION: Notice of exemption. manager qualifies as a QPAM or relies on the Consent Decree. Comments should be QPAM class exemption (PTE 84–14). A Covered addressed to the Assistant Attorney SUMMARY: This document contains a Plan does not include an ERISA-covered plan or notice of exemption issued by the IRA to the extent the UBS QPAM has expressly General, Environment and Natural disclaimed reliance on QPAM status or PTE 84–14 Resources Division, and should refer to Department of Labor (the Department) in entering into its contract, arrangement, or United States v. Hillcrest Industries, from certain of the prohibited agreement with the ERISA-covered plan or IRA.

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criminal conduct described in the expiration of this exemption without within 60 days of the Potential 2019 proposed exemption. Furthermore, the additional relief, or a determination that French Judgment Against UBS/UBS Department cautions that the relief in it is otherwise prudent for a plan to France if the Department has not issued this exemption will terminate terminate its relationship with an entity an Advisory Opinion within 60 days of immediately if, among other things, an covered by the exemption. the French First Instance Court’s entity within the UBS corporate judgment.3 The UBS QPAMs argue that Written Comments structure is convicted of a crime the notice should be required by the described in Section I(g) of PTE 84–14 The Department invited all interested later of 60 days from the date of (other than the Convictions or the 2019 persons to submit written comments judgment in the French First Instance French Judgment Against UBS/UBS and/or requests for a public hearing Court or 30 days after an advisory France) during the Exemption Period. with respect to the notice of proposed opinion is issued by the Department The terms of this exemption are exemption, published in the Federal that is adverse to the UBS QPAMs designed to promote adherence to basic Register at 84 FR 3818 on February 13, advisory opinion request. The UBS fiduciary standards under ERISA and 2019. All comments and requests for a QPAMs argue this would avoid the the Code. This exemption also aims to hearing were due by February 19, 2019. necessity of requiring the UBS QPAMs ensure that Covered Plans can terminate The Department received written to spend a significant amount of time relationships in an orderly and cost comments from the Applicant, the and resources notifying plans of an effective fashion in the event the National Federation of Independent exemption that would be inoperative fiduciary of a Covered Plan determines Business (NFIB), the Securities Industry and avoid disclosure of information that it is prudent to terminate the and Financial Markets Association would ultimately be superseded by an relationship with a UBS QPAM. The (SIFMA), and two members of the advisory opinion and require correction. Department notes that its determination public. After considering the entire The UBS QPAMs also request similar that the requisite findings under ERISA record developed in connection with revisions to the notice provision in section 408(a) have been met is the Applicant’s exemption request, the Section I(j)(7).4 premised on adherence to all of the Department has determined to grant the Department’s Response to Comment conditions of the exemption. exemption, with revisions, as described A. The Department declines to revise Accordingly, affected parties should be below. the proposed exemption as requested by aware that the conditions incorporated the UBS QPAMs. The Department has in this exemption are, taken as a whole, UBS QPAMs Comments construed Section I(g) as extending to necessary for the Department to grant 1. Effective Date and Notification the relief requested by the Applicant. Requirement 3 Absent these or similar conditions, the Proposed Section I(k) provides that: Within 60 A. The UBS QPAMs have also days of the judgment against UBS or UBS France Department would not have granted this requested that the Department issue an by the French First Instance Court, each UBS exemption. QPAM will provide a notice of the exemption, The Applicants requested an Advisory Opinion stating that an along with a separate summary describing the facts individual exemption pursuant to adverse judgment in the French First that led to the Convictions and the Potential 2019 section 408(a) of ERISA and section Instance Court would not constitute a French Judgment Against UBS/UBS France (the conviction within the meaning of Summary), which have been submitted to the 4975(c)(2) of the Code, and in Department, and a prominently displayed statement accordance with the procedures set Section I(g) of PTE 84–14. The UBS (the Statement) (collectively, Initial Notice) that the forth in 29 CFR part 2570, subpart B (76 QPAMs argue that if the Department Convictions and the Potential 2019 French FR 66637, 66644, October 27, 2011). determines that the French First Judgment Against UBS/UBS France, each separately Instance Court judgment does not result in a failure to meet a condition in PTE 84– Effective December 31, 1978, section 14 and PTE 2017–07, to each sponsor and beneficial 102 of the Reorganization Plan No. 4 of constitute a conviction under Section owner of a Covered Plan, or the sponsor of an 1978, 5 U.S.C. App. 1 (1996), transferred I(g) of PTE 84–14 either because investment fund in any case where a UBS QPAM the authority of the Secretary of the convictions in a foreign jurisdiction acts as a sub-advisor to the investment fund in generally are not covered by Section which such ERISA-covered plan and IRA invests. Treasury to issue administrative Effective as of the date that is 60 days after the exemptions under section 4975(c)(2) of I(g), or because the French First Instance Potential 2019 French Judgment Against UBS/UBS the Code to the Secretary of Labor. Court’s judgment, in particular, would France Date, all Covered Plan clients that enter into Accordingly, this exemption is being not constitute a conviction under a written asset or investment management Section I(g), then the one year agreement with a UBS QPAM after that date must granted solely by the Department. receive a copy of the exemption, the Summary, and exemption will have been unnecessary the Statement prior to, or contemporaneously with, Department’s Comment as there would be no conviction for the Covered Plan’s receipt of a written asset The Department cautions that the which an exemption is required. In that management agreement from the UBS QPAM. relief in this exemption will terminate case, the UBS QPAMs state that the Disclosures may be delivered electronically. 4 Section I(j)(7) requires: Within six months of the immediately if an entity within the UBS conditions of PTE 2017–07 should date of the judgment against UBS or UBS France by corporate structure is convicted of a continue to be effective. The UBS the French First Instance Court, each UBS QPAM crime described in Section I(g) of PTE QPAMs request that the Department must provide a notice of its obligations under this 84–14 (other than the Convictions and revise the exemption to make clear that Section I(j) to each Covered Plan. For prospective Covered Plans that enter into a written asset or the 2019 French Judgment Against UBS/ the exemption will expire automatically investment management agreement with a UBS UBS France) during the Exemption to the extent the Department issues an QPAM on or after the date of such a judgment, the Period. Although the UBS QPAMs could Advisory Opinion stating that the UBS QPAM will agree to its obligations under this apply for a new exemption in that Potential 2019 French Judgment Against Section I(j) in an updated investment management agreement between the UBS QPAM and such circumstance, the Department would UBS/UBS France does not constitute a clients or other written contractual agreement. This not be obligated to grant the exemption. conviction for purposes of Section I(g) condition will be deemed met for each Covered The terms of this exemption have been of PTE 84–14. Plan that received a notice pursuant to PTE 2016– specifically designed to permit plans to B. Additionally, the UBS QPAMs 17 and/or PTE 2017–07 that meets the terms of this condition. Notwithstanding the above, a UBS terminate their relationships in an request that section I(k) of the QPAM will not violate the condition solely because orderly and cost effective fashion in the exemption be revised so that the UBS a Plan or IRA refuses to sign an updated investment event of an additional conviction, or the QPAMs are not required to send notice management agreement.

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foreign convictions 5 and granted new aware and informed, at the soonest jurisdiction for a crime described in exemptions to convicted entities on the possible date, of the circumstances that Section I(g) of PTE 84–14.’’ (Emphases basis that foreign convictions were caused UBS to submit its request for this added.) disqualifying under I(g).6 In addition, exemption, along with the terms of this The Applicant requests the removal of although UBS asserts that the judgment exemption.7 Moreover, the sudden loss the reference to foreign convictions in of the French First Instance Court of an asset manager’s status as a QPAM Section I(l). In support of its request the should not count as a conviction for could, in some circumstances, be Applicant states the following: purposes of Section I(g) until such time disruptive, harmful, and/or expensive (A) The Department has not included as all appeals have been exhausted, for plans and IRAs with assets managed foreign convictions in any prior Section I(g) expressly provides that ‘‘a by the QPAM. Notice of the conviction, exemption, and should not do so for the person shall be deemed to have been the new exemption, its terms, and first time in a short-term, temporary ‘convicted’ from the date of the duration, enable plans and IRAs to exemption at a time when an advisory judgment of the trial court, regardless of protect their interests and to plan for opinion request has been made on the whether that judgment remains under future contingencies. question of whether foreign convictions appeal.’’ Notwithstanding the foregoing, should be disqualifying under PTE 84– The Department notes, however, that however, the Department recognizes 14; if UBS/UBS France is ultimately that the UBS QPAMs do not agree that (B) the inclusion of foreign exonerated on appeal, or if the the French First Instance Judgment convictions within Section I(l) is Department were to reverse its view on resulted in violation of Section I(g). problematic and not administratively the significance of the judgment of the Accordingly, the Department has feasible, as it would require the French First Instance Court or on modified Section I(k) so that the UBS Department to interpret and apply whether Section I(g) covers foreign QPAMs do not have to expressly foreign law with which it is not familiar convictions—the subject of the UBS acknowledge that the 2019 French and has no expertise; QPAMs’ advisory opinion request—the Judgment Against UBS/UBS France (C) the Department is exceeding its UBS QPAMs could continue to rely resulted in a failure to meet a condition authority by imposing a per se upon PTE 2017–07, irrespective of this in PTE 84–14 and PTE 2017–07, but disqualification that is more sweeping separate exemption, assuming they meet rather may simply recite that the than the disqualification Congress the other conditions of PTE 2017–07, Department of Labor has reached that enacted in Section 411 of ERISA; and and there are no subsequent conclusion (D) there are superior alternatives convictions. No change in exemption 2. The Condition Making Future Foreign available to the Department that are text is necessary for the UBS QPAMs in Convictions Disqualifying Should Be better suited to address concerns that that circumstance. Omitted may arise from a foreign conviction, including a case-by-case approach Department’s Response to Comment Section I(l) of the Proposed B. The Department declines to make the whereby the Department could assess Exemption provides that the exemption whether to modify or revoke the requested revision. Before granting an will ‘‘immediately terminate’’ in the exemption under Section 408(a) of exemption. event that ‘‘an entity within the UBS Department’s Response to A. As noted ERISA, the Department must conclude corporate structure’’ is ‘‘convicted of a that its conditions are protective of above, it is the Department’s view that crime described in Section I(g) of PTE Section I(g) of PTE 84–14 is not limited affected plans and IRAs. The 84–14 ..., or convicted in a foreign Department does not believe the to crimes committed in the United States, and extends to crimes committed exemption is sufficiently protective if 7 PTE 2015–15, for example, required each in foreign jurisdictions.8 UBS is permitted to delay required Deutsche Bank QPAM to provide a notice of the The quoted notification until after the Department exemption, along with a separate summary text in Section I(l) was merely intended resolved the pending advisory opinion describing the facts that led to the Convictions (the to remove any doubt as to the effect of Summary), which were submitted to the any future foreign conviction, not to cast request. In order to make informed Department, and a prominently displayed statement decisions, Plans and IRAs with assets (the Statement) that each Conviction separately doubt upon the Department’s past managed by UBS QPAMs should be resulted in a failure to meet a condition in PTE 84– application of Section I(g) to such 14, to each sponsor and beneficial owner of a convictions. After consideration of the Covered Plan that entered into a written asset or 5 comment, the Department has revised The purpose and intent of Section I(g) is investment management agreement with a DB explained in the Preamble to Proposed Prohibited QPAM on or before June 16, 2018, or the sponsor the condition to make it clear that the Transaction Exemption 84–14, 47 FR 56945, 56947 of an investment fund in any case where a DB exemption will ‘‘immediately (Dec. 21, 1982). That explanation provides: ‘‘A QPAM acts as a subadvisor to the investment fund QPAM, and those who may be in a position to terminate’’ if ‘‘an entity within the UBS in which such ERISA-covered plan and IRA invests. corporate structure’’ is ‘‘convicted of a influence its policies, are expected to maintain a In that exemption, the ‘‘term ‘Convictions’ means high standard of integrity. Accordingly, the (1) the judgment of conviction against DB Group crime described in Section I(g) of PTE proposed exemption does not cover transactions if Services that was entered on April 18, 2017, in case 84–14 . . . , including a conviction in the QPAM or various affiliates have been convicted number 3:15–cr–00062–RNC in the United States of various crimes (outlined in section I(g) of the a foreign jurisdiction.’’ District Court for the District of Connecticut to a The Department stresses that a key proposal), that involve abuse or misuses of a single count of wire fraud, in violation of 18 U.S.C. position of trust, or felonies generally described in 1343 and (2) the judgment of conviction against purpose of Section I(g) is to ensure that ERISA section 411.’’ The Department notes that, in DSK entered on January 25, 2016, in Seoul Central a ‘‘QPAM, and those who may be in a relevant part, neither the language nor the intent of District Court, relating to charges filed against DSK position to influence its policies, are the provision in Section I(g) changed between the under Articles 176, 443, and 448 of South Korea’s expected to maintain a high standard of proposed exemption and the final Prohibited Financial Investment Services and Capital Markets Transaction Exemption 84–14. Act for spot/futures-linked market price 6 See, for example, the following exemptions manipulation. For all purposes under this 8 See, for example, the following exemptions issued by the Department, involving foreign exemption, ‘conduct’ of any person or entity that is issued by the Department, involving foreign convictions: Citigroup Inc., PTE 2012–08, 77 FR the ‘subject of [a] Conviction’ encompasses the convictions: Citigroup Inc., PTE 2012–08, 77 FR 19344 (March 30, 2012); Royal Bank of Canada, PTE factual allegations described in Paragraph 13 of the 19344 (March 30, 2012); Royal Bank of Canada, PTE 2016–10, 81 FR 75147 (October 28, 2016); Northern Plea Agreement filed in the District Court in case 2016–10, 81 FR 75147 (October 28, 2016); Northern Trust Corporation, PTE 2016–11, 81 FR 75150 number 3:15–cr–00062–RNC, and in the ‘Criminal Trust Corporation, PTE 2016–11, 81 FR 75150 (October 28, 2016); Deutsche Bank, PTE 2015–15 80 Acts’ section pertaining to ‘Defendant DSK’ in the (October 28, 2016); Deutsche Bank, PTE 2015–15 80 FR 53574, (September 4, 2015). Decision of the Seoul Central District Court.’’ FR 53574, (September 4, 2015).

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integrity.’’ 9 Particularly in light of the reference to foreign convictions is Comment 3—Proposed Modifications to 2019 French Judgment Against UBS/ necessary to safeguard the interests of the Conditions in PTE 2017–07—Section UBS France, the Department believes it plan participants and IRA owners. I(a), I(b) and I(h)(2) is important to make clear when the Department’s response to Comment C. The UBS QPAMs state that the UBS QPAMs would not be permitted to Section 411 of ERISA enumerates exemption should contain the same continue to rely on this exemption if specific crimes that disqualify convicted conditions as PTE 2017–07 and those any entity in the QPAM corporate persons from acting as service providers conditions should not have been structure is convicted of another serious modified for purposes of this one-year foreign crime. In that circumstance, the and fiduciaries to ERISA-covered plans. The exemption condition, in contrast, exemption. In the UBS QPAMs’ view, Department would have significant the Department should not impose cause for concern about the QPAMs’ conditions a QPAM’s ability to engage in otherwise prohibited transactions on additional conditions, without first standards of integrity. Accordingly, they resolving whether the adverse judgment would be expected to submit a new the QPAM’s avoidance of serious criminal misconduct, so that the in the French First Instance Court application for an exemption based on constitutes a conviction under Section Department can have an appropriate full disclosure of the relevant facts and I(g) of PTE 84–14. Additionally, the UBS level of confidence that the institution the Department’s full evaluation of the QPAMs state that the modifications to maintains a standard of high integrity. significance of those facts. the conditions of PTE 2017–07 do not Department’s Response to Comment In other words, Section 411 prohibits take into account the UBS QPAMs’ B. The Department does not agree that conduct that would otherwise be legal, record of compliance with the terms of a condition that requires the UBS while the exemption permits conduct their prior exemptions. QPAMs to avoid covered foreign that would otherwise be illegal. Section Section I(a) of the proposed convictions results in an exemption that I(g) of the QPAM exemption has always exemption provides in part that ‘‘[t]he is not administratively feasible for the covered crimes that are not expressly UBS QPAMs (including their officers, Department to implement. Although covered by Section 411 of ERISA; it directors, agents other than UBS, UBS foreign laws and legal structures can be Securities Japan, and UBS France), and complex, the Department can draw serves a related, but different, purpose than Section 411. employees of such UBS QPAMs and any upon a variety of resources (including other party engaged on behalf of such submissions by the applicant) to Section 408(a) of ERISA requires the UBS QPAMs who had responsibility for, determine if a conviction falls within Department to limit the availability of or exercised authority in connection Section I(g), as well as to determine the administrative exemptions to with the management of plan assets did weight that the Department should give transactions and arrangements that are not know of, did not have reason to the conviction in deciding whether to protective of, and in the interest of, know of, or participate in: (1) The FX grant a new exemption and how to affected plans and IRAs, and Misconduct; (2) the criminal conduct of structure the exemption. administratively feasible. As discussed UBS Securities Japan and UBS that is As noted above, the Department has above, the condition on foreign the subject of the Convictions; or (3) the previously granted exemptions convictions is critical to the criminal conduct of UBS and UBS following foreign convictions, without Department’s determination that the France that is the subject of the significant difficulty in administration. exemption at issue here meets the Potential 2019 French Judgment Against The question of whether a foreign statutory test. UBS/UBS France.’’ Section I(b) of the conviction falls within such categories proposed exemption provides that as a ‘‘felony arising out of the conduct Department’s Response to Comment ‘‘[t]he UBS QPAMs (including their of the business of a broker, dealer, D. The Department disagrees with the officers, directors, agents other than investment adviser, bank, insurance comment. Another serious foreign UBS, UBS Securities Japan, and UBS company, or fiduciary’’ or ‘‘income tax conviction would call into question the France, and employees of such UBS evasion’’, within the meaning of the basis for permitting the UBS QPAMs to QPAMs and any other parties engaged exemption, is not inherently more engage in prohibited transactions. If a on behalf of such UBS QPAMs) did not difficult or less administrable than trial court makes a determination of receive direct compensation, or many of the questions that the criminal misconduct, it would be knowingly receive indirect Department routinely considers in the appropriate to place the burden of compensation, in connection with (1) exemption process (e.g., questions seeking a new exemption on the UBS the FX Misconduct; (2) the criminal relating to complex and unfamiliar QPAMs. At that time, the Department conduct of UBS Securities Japan and financial transactions). would expect full disclosure of the UBS that is the subject of the A service provider’s conviction for a wrongdoing that resulted in the Convictions; or (3) the criminal conduct serious foreign crime is relevant to a conviction; the reasons (if any) that the of UBS and UBS France that is the fiduciary’s analysis of whether to retain Department should not be concerned subject of the Potential 2019 French the service provider, and it is similarly about granting the QPAMs continued Judgment Against UBS/UBS France.’’ relevant to the Department’s relief from ERISA’s prohibited The UBS QPAMs state that requiring determination of whether to grant the these conditions to apply to third service provider relief from otherwise transaction provisions; and the basis for parties effectively conditions the prohibited transactions.10 The express concluding that the UBS QPAMs will perform their fiduciary responsibilities exemption on facts regarding third parties that the UBS QPAMs are not in 9 Preamble to Proposed Prohibited Transaction with a high standard of integrity. The Exemption 84–14, 47 FR 56945, 56947 (Dec. 21, Department could then conduct a full a position to know or confirm, and that 1982). analysis of whether and how to grant the conditions, therefore, are not in the 10 In this regard, when selecting or monitoring an any further relief. This approach is both interest of participants and asset manager, plan fiduciaries should not disregard administrable and appropriately beneficiaries. The UBS QPAMs foreign crimes committed by an entity within the additionally claim that the Department asset manager’s corporate structure, merely because protective of the interests of plans, plan the crimes may be complicated or difficult to participants, and IRA owners. previously had found that the interpret. conditions described in PTE 2017–07

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were sufficient to isolate the investment Japan and UBS that is the subject of the Given the requirement of the and compliance operations of the Convictions; or (3) the criminal conduct independent audit and the public QPAMs from the influence of bad of UBS and UBS France that is the availability of the audit report, the actors. The UBS QPAMs also argue that subject of the 2019 French Judgment Department has determined not to modifications to existing conditions that Against UBS/UBS France. Further, any include the additional requirement of are specific to the conduct underlying other party engaged on behalf of such separate notice to ‘‘a fiduciary of any prior convictions runs afoul of the UBS QPAMs who had responsibility for, affected Covered Plan.’’ The Department Department’s regulations at 29 CFR or exercised authority in connection has modified section I(h)(2) accordingly. 2570.50. According to the UBS QPAMs, with the management of plan assets did Comment 4(a)—Definition of ‘‘Conduct’’ this regulation requires the Department not receive direct compensation, or That Is the ‘‘Subject Of’’ an Adverse notify the applicant of its proposed knowingly receive indirect First Instance Judgment—Section II(b) actions and reasons prior to publication compensation, in connection with the of a notice proposing a modification or criminal conduct of UBS and UBS Section II(b) of the proposed revocation. If the Department declines France that is the subject of the 2019 exemption provides in part ‘‘[f]or all to delete the third party language French Judgment Against UBS/UBS purposes under this exemption, entirely, the UBS QPAMs request that France.’’ ‘‘conduct’’ of any person or entity that the language apply only to the Potential Section I(h)(2) of the proposed is the ‘‘subject of the alleged criminal 2019 French Judgment Against UBS/ exemption provides that ‘‘Any violation conduct that may be the subject of the UBS France. of, or failure to comply with an item in Potential 2019 French Judgment Against Today the Department is granting a subparagraphs (h)(1)(ii) through UBS/UBS France’’ encompasses any new exemption based on the application (h)(1)(vi), is corrected as soon as conduct of UBS, its affiliates, or UBS from the UBS QPAMs and is not reasonably possible upon discovery, or France and/or their personnel that is modifying PTE 2017–07. The as soon after the QPAM reasonably described in any such judgment.’’ The Department has determined to modify should have known of the UBS QPAMs argue that unlike in prior section I(a) and I(b) from the language noncompliance (whichever is earlier), exemptions that used a similar of the proposed exemption to reflect and any such violation or compliance formulation of ‘‘conduct’’, UBS does not that the language ‘‘any other party failure not so corrected is reported, know at this time the specific conduct engaged on behalf of such UBS QPAMs upon the discovery of such failure to so that will be described in any adverse who had responsibility for, or exercised correct, in writing. Such report shall be judgment by the French First Instance authority in connection with the made to the head of compliance and the Court. The UBS QPAMs claim that management of plan assets’’ will be General Counsel (or their functional under French criminal procedure the applicable only for purposes of the equivalent) of the relevant UBS QPAM description of the conduct would not be criminal conduct of UBS and UBS that engaged in the violation or failure, finalized until after the date of the France that is the subject of the 2019 and, the independent auditor adverse judgment, and possibly months French Judgment Against UBS/UBS responsible for reviewing compliance later. The UBS QPAMS state they have France. with the Policies, and a fiduciary of any no reason to believe they will unable to Accordingly, Section I(a) is revised in affected Covered Plan where such satisfy conditions in the exemption to part as follows: ‘‘I(a) The UBS QPAMS fiduciary is independent of UBS.’’ which the definition in Section II(b) (including their officers, directors, The UBS QPAMs request that the would apply, but that they believe those agents other than UBS, UBS Securities, language regarding reporting conditions should only be operative Japan and UBS France, and the uncorrected policy violations or after the written description of the employees of such UBS QPAMs), did compliance failures to ‘‘a fiduciary of judgment has been issued and the UBS not have reason to know of, or any affected Covered Plan’’ should be QPAMs have opportunity to review the participate in: (1) The FX Misconduct; omitted from the exemption. The UBS description. Therefore, the UBS QPAMS (2) the criminal conduct of UBS QPAMs state that the Department request that Section II(b) be revised to Securities Japan and UBS that is the previously proposed this requirement in provide that any conditions based on subject of the Convictions; or (3) the other exemptions but omitted the the conduct described in any adverse criminal conduct of UBS and UBS requirement from the final exemptions First Instance Judgment only become France that is the subject of the 2019 due to the concerns of the applicants. effective 60 days after the final written French Judgment Against UBS/UBS The UBS QPAMs claim it will be description for the judgment is issued. France. Further, any other party engaged problematic to comply with this The Department is not making the on behalf of such UBS QPAMs who had requirement because: It is uncertain requested revision to the definition in responsibility for, or exercised authority when the uncorrected violations or Section II(b). The Department believes in connection with the management of failures must be reported to the plan that UBS has sufficient information of plan assets did not know of, did not fiduciaries; due to a lack of materiality the conduct at issue to comply with the have reason to know of, or participate in threshold, this requirement may prompt exemption condition. However, the the criminal conduct of UBS and UBS frequent reports of technical or Department has revised Section II(b) to France that is the subject of the 2019 insignificant violations requiring the provide more clarity. To make the French Judgment Against UBS/UBS expenditure of time and resources required findings under section 408(a) France.’’ Section I(b) is revised as without any benefit to plans; and the of ERISA, the Department concludes follows: (b) The UBS QPAMs (including condition is unclear on how many that the conditions relating to criminal their officers, directors, agents other fiduciaries of a plan must receive the conduct should be applied as of the than UBS, UBS Securities Japan, and report. Moreover, the UBS QPAMs argue effective date of the exemption. UBS France, and employees of such that requirement is unnecessary given UBS QPAMs) did not receive direct the requirement that the independent Comment 4(b)—Structure of UBS compensation, or knowingly receive auditor will evaluate any uncorrected Compliance Function—Section indirect compensation, in connection violations or compliance failures and I(m)(1)(ii) with the (1) the FX Misconduct; (2) the the violations will be addressed in audit The UBS QPAMs requested that criminal conduct of UBS Securities reports which are publically available. Section I(m)(1)(ii) of the exemption be

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modified to correctly reflect the current exemption to be immediately condition in section I(l) and the structure of UBS’s compliance function. unavailable. comment has been addressed above. Accordingly, the Department has SIFMA argues that all the Comments From the Public deleted the phrase ‘‘the Global Head of considerations described in Small v. C&ORC, who will report directly to United States 11 in support of the The Department received two UBS’s Chief Risk Officer’’ from Section Court’s construction of a statute are also comments from the public. One I(m)(1)(ii). relevant in determining whether commenter stated that he thought the exemption conditions based on foreign exemption was a ‘‘good rule.’’ A second National Federation of Independent commenter noted that he agreed with Business convictions meet the administratively feasible requirement of ERISA section the Department that performance of the The Department received a comment 408(a). According to SIFMA, in order to exemption audit on less than an annual from the National Federation of make a determination that any foreign basis will weaken an important plan Independent Business (NFIB) stating the conviction should be disqualifying, the protection. This commenter also stated that he agreed that an annual review by Department should afford interested Department would have to understand an independent auditor of a QPAM’s persons a longer time period to view and apply the criminal laws and written policies and procedures and a files with respect to proposed criminal procedures of any one of representative sample of plan exemptions, and to comment on the hundreds of foreign countries, as well as transactions is necessary to address the exemptions. The NFIB states that longer the cases decided under those laws. In lack of QPAM independence. Lastly, time periods are necessary to afford SIFMA’s view, the reasons cited by the this commenter noted that he agreed them the notice and opportunity to be Supreme Court in Small as weighing with the Department’s assessment of heard to which the law entitles them, against asking prosecutors or judges to costs associated with the exemption and would give the Department the time ‘‘refine’’ these ‘‘definitional audit and expressed approval for the necessary to make better-informed distinctions’’ on the facts of that case ‘‘proposed amendments.’’ decisions. NFIB also claims that the equally weigh against the Department’s Department should take greater care to finding that an exemption referencing General Information ensure compliance with the procedural foreign convictions is administratively The attention of interested persons is requirements set by statute for the grant feasible within the meaning of ERISA directed to the following: of exemptions in order to avoid the risk section 408(a)(1). This is especially true, (1) The fact that a transaction is the of successful legal challenges to its according to SIFMA, where the subject of an exemption under section exemptions. likelihood of ‘‘getting it wrong’’ is high, 408(a) of the Act or section 4975(c)(2) of In response to these assertions, the in light of the complexities and vagaries the Code does not relieve a fiduciary or Department stresses that the comment of foreign law.’’ The Department’s other party in interest or disqualified period was appropriate under the response to UBS’s comments above, person from certain other provisions of circumstances of this particular particularly UBS’s comments on the Act and/or the Code, including any proposed exemption. The period was whether the exemption is prohibited transaction provisions to necessarily limited because of the administratively feasible, effectively which the exemption does not apply potential for an adverse judgment in the address these points. and the general fiduciary responsibility French First Instance Court on February In light of the 2019 French Judgment provisions of section 404 of the Act, 20, 2019, which could prevent the UBS Against UBS/UBS France, the which, among other things, require a QPAMs from continuing to rely upon Department believes it is important to fiduciary to discharge his duties the relief provided by PTE 84–14 and make clear when the UBS QPAMs respecting the plan solely in the interest potentially cause harm to participants would not be permitted to continue to of the participants and beneficiaries of and beneficiaries. This exemption is for rely on this exemption if a member of the plan and in a prudent fashion in a temporary one-year period and if the the UBS corporate family is convicted of accordance with section 404(a)(1)(B) of UBS QPAMs apply for longer term another serious foreign crime. In that the Act; nor does it affect the exemptive relief, the Department will circumstance, the Department would requirement of section 401(a) of the consider and afford a longer comment have still greater cause for concern Code that the plan must operate for the period for such relief, as appropriate. about whether the UBS QPAMs and exclusive benefit of the employees of SIFMA Comment those in a position to influence their the employer maintaining the plan and policies, maintain high standards of their beneficiaries; The Department received a comment integrity and about the appropriateness (2) In accordance with section 408(a) from the Securities Industry and of relief from the prohibited transaction of ERISA and section 4975(c)(2) of the Financial Markets Association (SIFMA) provisions, which were enacted to Code, the Department makes the urging the Department to issue an protect plans, participants, and IRA following determinations: The advisory opinion that section I(g) does owners from potentially abusive exemption is administratively feasible, not encompass foreign crimes. SIFMA transactions. In that circumstance, the the exemption is in the interests of states that if the Department does not Department has concluded that it would affected plans and of their participants issue the requested advisory opinion to be appropriate for the UBS QPAMs to and beneficiaries, and the exemption is SIFMA that section I(g) does not seek a new exemption based upon a full protective of the rights of participants encompass foreign crimes, and declines consideration of the record and the and beneficiaries of such plans; to issue an advisory opinion to UBS on misconduct at issue, rather than to rely (3) The exemption is supplemental to, the effect of the French judgment on upon an exemption that predates the and not in derogation of, any other section I(g), and instead moves forward new misconduct and the Department’s provisions of ERISA, including statutory with this proposed temporary consideration of that misconduct. The or administrative exemptions and exemption application, it should delete Applicants have also commented on the transitional rules. Furthermore, the fact the condition in section 1(l) that adds that a transaction is subject to an foreign convictions to the type of 11 See Small v. United States, 544 U.S. 385, 388– administrative or statutory exemption is convictions that would cause the 89 (2005). not dispositive of whether the

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transaction is in fact a prohibited ‘‘participate in’’ refers not only to active 2019 French Judgment Against UBS/ transaction; and participation in the FX Misconduct, the UBS France; (4) The availability of this exemption misconduct underlying the Convictions, (f) A UBS QPAM did not exercise is subject to the express condition that and the misconduct underlying the 2019 authority over the assets of any plan the material facts and representations French Judgment Against UBS/UBS subject to Part 4 of Title I of ERISA (an contained in the application accurately France, but also to knowing approval of ERISA-covered plan) or section 4975 of describe all material terms of the that misconduct, or knowledge of such the Code (an IRA) in a manner that it transaction which is the subject of the misconduct without taking active steps knew or should have known would: exemption. to prohibit such conduct, such as Further the FX Misconduct, the criminal Accordingly, the following exemption reporting the conduct to supervisors, conduct that is the subject of the is granted under the authority of section including the Board of Directors; Convictions, or the criminal conduct of 408(a) of ERISA and section 4975(c)(2) (b) The UBS QPAMs (including their UBS and UBS France that is the subject of the Code and in accordance with the officers, directors, agents other than of the 2019 French Judgment Against procedures set forth in 29 CFR part UBS, UBS Securities Japan, and UBS UBS/UBS France; or cause the UBS 2570, subpart B (76 FR 66637, 66644, France, and employees of such UBS QPAM or its affiliates to directly or October 27, 2011): QPAMs) did not receive direct indirectly profit from the FX Exemption compensation, or knowingly receive Misconduct, the criminal conduct that indirect compensation, in connection is the subject of the Convictions, or the Section I. Covered Transactions with the (1) the FX Misconduct; (2) the criminal conduct of UBS and UBS Certain entities with specified criminal conduct of UBS Securities France that is the subject of the 2019 relationships to UBS (hereinafter, the Japan and UBS that is the subject of the French Judgment Against UBS/UBS UBS QPAMs, as defined in Sections Convictions; or (3) the criminal conduct France; II(e)) will not be precluded from relying of UBS and UBS France that is the (g) Other than with respect to on the exemptive relief provided by subject of the 2019 French Judgment employee benefit plans maintained or Prohibited Transaction Class Exemption Against UBS/UBS France. Further, any sponsored for its own employees or the 84–14 (PTE 84–14 or the QPAM other party engaged on behalf of such employees of an affiliate, UBS, UBS Exemption),12 notwithstanding the 2013 UBS QPAMs who had responsibility for, Securities Japan, and UBS France will Conviction of UBS Securities Japan Co., or exercised authority in connection not act as fiduciaries within the Ltd., the 2018 Conviction of UBS with the management of plan assets did meaning of section 3(21)(A)(i) or (iii) of (collectively the Convictions, as defined not receive direct compensation, or ERISA, or section 4975(e)(3)(A) and (C) in Section II(a)), and the 2019 French knowingly receive indirect of the Code, with respect to ERISA- compensation, in connection with the Judgment Against UBS/UBS France (as covered plan and IRA assets; provided, criminal conduct of UBS and UBS defined in Section II(b)) during the however, that UBS, UBS Securities France that is the subject of the 2019 Exemption Period, provided that the Japan, and UBS France will not be 13 French Judgment Against UBS/UBS following conditions are satisfied: treated as violating the conditions of (a) The UBS QPAMS (including their France; (c) The UBS QPAMs will not employ this exemption solely because it acted as officers, directors, agents other than an investment advice fiduciary within UBS, UBS Securities, Japan and UBS or knowingly engage any of the individuals who participated in: (1) The the meaning of section 3(21)(A)(ii) of France, and the employees of such UBS ERISA or section 4975(e)(3)(B) of the QPAMs, did not have reason to know of, FX Misconduct; (2) the criminal conduct of UBS Securities Japan and Code; or participate in: (1) The FX (h)(1) Each UBS QPAM must continue Misconduct; (2) the criminal conduct of UBS that is the subject of the Convictions; or (3) the criminal conduct to maintain, adjust (to the extent UBS Securities Japan and UBS that is necessary), implement, and follow the subject of the Convictions; or (3) the of UBS and UBS France that is the subject of the 2019 French Judgment written policies and procedures (the criminal conduct of UBS and UBS Policies). The Policies must require, and France that is the subject of the 2019 Against UBS/UBS France; must be reasonably designed to ensure French Judgment Against UBS/UBS (d) At all times during the Exemption that: France. Further, any other party engaged Period, no UBS QPAM will use its (i) The asset management decisions of on behalf of such UBS QPAMs who had authority or influence to direct an the UBS QPAM are conducted responsibility for, or exercised authority ‘‘investment fund’’ (as defined in independently of UBS’s corporate in connection with the management of Section VI(b) of PTE 84–14) that is plan assets did not know of, did not subject to ERISA or the Code and management and business activities, have reason to know of, or participate in managed by such UBS QPAM with including the corporate management the criminal conduct of UBS and UBS respect to one or more Covered Plans (as and business activities of the Investment France that is the subject of the 2019 defined in Section II(c)) to enter into Bank division, UBS Securities Japan, French Judgment Against UBS/UBS any transaction with UBS, UBS and UBS France; this condition does not France. For purposes of this exemption, Securities Japan, or UBS France or to preclude a UBS QPAM from receiving engage UBS, UBS Securities Japan, or publicly available research and other 12 49 FR 9494 (March 13, 1984), as corrected at UBS France to provide any service to widely available information from a 50 FR 41430, (October 10, 1985), as amended at 70 such investment fund, for a direct or UBS affiliate; FR 49305(August 23, 2005), and as amended at 75 indirect fee borne by such investment (ii) The UBS QPAM fully complies FR 38837 (July 6, 2010), hereinafter referred to as fund, regardless of whether such with ERISA’s fiduciary duties, and with ‘‘PTE 84–14’’ or the ‘‘QPAM Exemption.’’ 13 Section I(g) of PTE 84–14 generally provides transaction or service may otherwise be ERISA and the Code’s prohibited that ‘‘[n]either the QPAM nor any affiliate thereof within the scope of relief provided by transaction provisions, in each case as . . . nor any owner . . . of a 5 percent or more an administrative or statutory applicable with respect to each Covered interest in the QPAM is a person who within the exemption; Plan, and does not knowingly 10 years immediately preceding the transaction has been either convicted or released from (e) Any failure of the UBS QPAMs to participate in any violation of these imprisonment, whichever is later, as a result of’’ satisfy Section I(g) of PTE 84–14 arose duties and provisions with respect to certain criminal activity therein described. solely from the Convictions and the Covered Plans;

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(iii) The UBS QPAM does not not complying with the conditions of transactional data; workplace locations; knowingly participate in any other this exemption (including any loss of training materials; and personnel. Such person’s violation of ERISA or the Code exemptive relief provided herein), and access is limited to information relevant with respect to Covered Plans; prompt reporting of wrongdoing; and to the auditor’s objectives as specified (iv) Any filings or statements made by (ii) Be conducted by a professional by the terms of this exemption; the UBS QPAM to regulators, including, who has been prudently selected and (3) The auditor’s engagement must but not limited to, the Department, the who has appropriate technical training specifically require the auditor to Department of the Treasury, the and proficiency with ERISA and the determine whether each UBS QPAM has Department of Justice, and the Pension Code; developed, implemented, maintained, Benefit Guaranty Corporation, on behalf (i)(1) Each UBS QPAM submits to an and followed the Policies in accordance of or in relation to Covered Plans, are audit conducted by an independent with the conditions of this exemption, materially accurate and complete, to the auditor, who has been prudently and has developed and implemented best of such QPAM’s knowledge at that selected and who has appropriate the Training, as required herein; time; technical training and proficiency with (4) The auditor’s engagement must (v) To the best of the UBS QPAM’s ERISA and the Code, to evaluate the specifically require the auditor to test knowledge at that time, the UBS QPAM adequacy of, and each UBS QPAM’s each UBS QPAM’s operational does not make material compliance with, the Policies and compliance with the Policies and misrepresentations or omit material Training described herein. The audit Training. In this regard, the auditor information in its communications with requirement must be incorporated in the must test, for each UBS QPAM, a such regulators with respect to Covered Policies. The audit must cover the sample of such UBS QPAM’s Plans, or make material Exemption Period and must be transactions involving Covered Plans, misrepresentations or omit material completed no later than six (6) months sufficient in size and nature to afford information in its communications with after the end of the exemption period. the auditor a reasonable basis to Covered Plans; For time periods ending prior to the determine such UBS QPAM’s (vi) The UBS QPAM complies with judgment against UBS or UBS France by operational compliance with the the terms of this exemption; the French First Instance Court and Policies and Training; (2) Any violation of, or failure to covered by the audit required pursuant (5) For the audit, on or before the end comply with an item in subparagraphs to PTE 2017–07,14 the audit of the relevant period described in (h)(1)(ii) through (h)(1)(vi), is corrected requirements in Section I(i) of PTE Section I(i)(1) for completing the audit, as soon as reasonably possible upon 2017–07 will remain in effect. The audit the auditor must issue a written report discovery, or as soon after the QPAM under PTE 2017–07 covering the time (the Audit Report) to UBS and the UBS reasonably should have known of the period from January 10, 2018 until the QPAM to which the audit applies that noncompliance (whichever is earlier), date of the judgment against UBS or describes the procedures performed by and any such violation or compliance UBS France by the French First Instance the auditor in connection with its failure not so corrected is reported, Court must be completed within six (6) examination. The auditor, at its upon the discovery of such failure to so months of the date of any such discretion, may issue a single correct, in writing. Such report shall be judgment, and the corresponding consolidated Audit Report that covers made to the head of compliance and the certified Audit Report must be all the UBS QPAMs. The Audit Report General Counsel (or their functional submitted to the Department no later must include the auditor’s specific equivalent) of the relevant UBS QPAM than 45 days following the completion determinations regarding: that engaged in the violation or failure, of such audit; 15 (i) The adequacy of each UBS QPAM’s and the independent auditor (2) Within the scope of the audit and Policies and Training; each UBS responsible for reviewing compliance to the extent necessary for the auditor, QPAM’s compliance with the Policies with the Policies. A UBS QPAM will not in its sole opinion, to complete its audit and Training; the need, if any, to be treated as having failed to develop, and comply with the conditions for strengthen such Policies and Training; implement, maintain, or follow the relief described herein, and only to the and any instance of the respective UBS Policies, provided that it corrects any extent such disclosure is not prevented QPAM’s noncompliance with the instance of noncompliance as soon as by state or federal statute, or involves written Policies and Training described reasonably possible upon discovery, or communications subject to attorney in Section I(h) above. The UBS QPAM as soon as reasonably possible after the client privilege, each UBS QPAM and, must promptly address any QPAM reasonably should have known if applicable, UBS, will grant the auditor noncompliance. The UBS QPAM must of the noncompliance (whichever is unconditional access to its business, promptly address or prepare a written earlier), and provided that it adheres to including, but not limited to: Its plan of action to address any the reporting requirements set forth in computer systems; business records; determination as to the adequacy of the this subparagraph (vii); Policies and Training and the auditor’s (3) Each UBS QPAM will maintain, 14 82 FR 61903 (December 29, 2017). PTE 2017– recommendations (if any) with respect adjust (to the extent necessary) and 07 is an exemption that permits UBS QPAMs to rely to strengthening the Policies and implement a program of training during on the exemptive relief provided by PTE 84–14, Training of the respective UBS QPAM. notwithstanding the 2013 and 2018 Convictions. the Exemption Period, to be conducted 15 Pursuant to PTE 2017–07, the initial audit Any action taken or the plan of action during the Exemption Period, for all period begins on January 10, 2018 and ends on to be taken by the respective UBS relevant UBS QPAM asset/portfolio March 9, 2019, and the corresponding Audit Report QPAM must be included in an management, trading, legal, compliance, must be completed by September 9, 2019 and the addendum to the Audit Report (such Audit Report submitted to the Department within and internal audit personnel. The 45 days after completion. Accordingly, the last addendum must be completed prior to Training must: audit performed pursuant to PTE 2017–07 will the certification described in Section (i) At a minimum, cover the Policies, cover the period beginning January 10, 2018 and I(i)(7) below). In the event such a plan ERISA and Code compliance (including ending on the date of judgment against UBS or UBS of action to address the auditor’s France by the French First Instance Court. The applicable fiduciary duties and the corresponding Audit Report must be completed recommendation regarding the prohibited transaction provisions), within six months of the judgment and submitted adequacy of the Policies and Training is ethical conduct, the consequences for to the Department within 45 days of completion. not completed by the time of

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submission of the Audit Report, the (9) Each UBS QPAM provides its applicable, and of the prohibited following period’s Audit Report must certified Audit Report, by regular mail transaction provisions of ERISA and the state whether the plan was satisfactorily to: Office of Exemption Determinations Code, as applicable; a breach of contract completed. Any determination by the (OED), 200 Constitution Avenue NW, by the QPAM; or any claim arising out auditor that a UBS QPAM has Suite 400, Washington, DC 20210; or by of the failure of such UBS QPAM to implemented, maintained, and followed private carrier to: 122 C Street NW, qualify for the exemptive relief provided sufficient Policies and Training must Suite 400, Washington, DC 20001–2109. by PTE 84–14 as a result of a violation not be based solely or in substantial part This delivery must take place no later of Section I(g) of PTE 84–14 other than on an absence of evidence indicating than 45 days following completion of the Convictions and the 2019 French noncompliance. In this last regard, any the Audit Report. The Audit Report will Judgment Against UBS/UBS France. finding that a UBS QPAM has complied be made part of the public record This condition applies only to actual with the requirements under this regarding this exemption. Furthermore, losses caused by the UBS QPAM’s subparagraph must be based on each UBS QPAM must make its Audit violations. evidence that the particular UBS QPAM Report unconditionally available, (3) Not to require (or otherwise cause) has actually implemented, maintained, electronically or otherwise, for the Covered Plan to waive, limit, or and followed the Policies and Training examination upon request by any duly qualify the liability of the UBS QPAM required by this exemption. authorized employee or representative for violating ERISA or the Code or Furthermore, the auditor must not of the Department, other relevant engaging in prohibited transactions; solely rely on the Exemption Report regulators, and any fiduciary of a (4) Not to restrict the ability of such created by the compliance officer (the Covered Plan; Covered Plan to terminate or withdraw Compliance Officer), as described in (10) Any engagement agreement with from its arrangement with the UBS Section I(m) below, as the basis for the an auditor to perform the audit required QPAM with respect to any investment auditor’s conclusions in lieu of under the terms of this exemption that in a separately managed account or independent determinations and testing is entered subsequent to the date of the pooled fund subject to ERISA and performed by the auditor as required by judgment against UBS or UBS France by managed by such QPAM, with the Section I(i)(3) and (4) above; and the French First Instance Court must be exception of reasonable restrictions, (ii) The adequacy of the Exemption submitted to OED no later than two (2) appropriately disclosed in advance, that Review described in Section I(m); months after the execution of such are specifically designed to ensure (6) The auditor must notify the agreement; equitable treatment of all investors in a respective UBS QPAM of any instance (11) The auditor must provide the pooled fund in the event such of noncompliance identified by the Department, upon request, for withdrawal or termination may have auditor within five (5) business days inspection and review, access to all the adverse consequences for all other after such noncompliance is identified workpapers created and utilized in investors. In connection with any such by the auditor, regardless of whether the connection with the audit, provided arrangements involving investments in audit has been completed as of that such access and inspection is otherwise pooled funds subject to ERISA entered date; permitted by law; and into after the effective date of PTE 2017– (7) With respect to the Audit Report, (12) UBS must notify the Department 07, the adverse consequences must the General Counsel, or one of the three of a change in the independent auditor relate to a lack of liquidity of the most senior executive officers of the no later than two (2) months after the underlying assets, valuation issues, or UBS QPAM to which the Audit Report engagement of a substitute or regulatory reasons that prevent the fund applies, must certify in writing, under subsequent auditor and must provide an from promptly redeeming an ERISA- penalty of perjury, that the officer has explanation for the substitution or covered plan’s or IRA’s investment, and reviewed the Audit Report and this change including a description of any such restrictions must be applicable to exemption; that, to the best of such material disputes between the all such investors and be effective no officer’s knowledge at the time, such terminated auditor and UBS; longer than reasonably necessary to UBS QPAM has addressed, corrected, (j) As of the date of the judgment avoid the adverse consequences; remedied any noncompliance and against UBS or UBS France by the (5) Not to impose any fees, penalties, inadequacy or has an appropriate French First Instance and throughout or charges for such termination or written plan to address any inadequacy the Exemption Period, with respect to withdrawal with the exception of regarding the Policies and Training any arrangement, agreement, or contract reasonable fees, appropriately disclosed identified in the Audit Report. Such between a UBS QPAM and a Covered in advance, that are specifically certification must also include the Plan, the UBS QPAM agrees and designed to prevent generally signatory’s determination, that, to the warrants to Covered Plans: recognized abusive investment practices best of such officer’s knowledge at the (1) To comply with ERISA and the or specifically designed to ensure time, the Policies and Training in effect Code, as applicable with respect to such equitable treatment of all investors in a at the time of signing are adequate to Covered Plan; to refrain from engaging pooled fund in the event such ensure compliance with the conditions in prohibited transactions that are not withdrawal or termination may have of this exemption and with the otherwise exempt (and to promptly adverse consequences for all other applicable provisions of ERISA and the correct any inadvertent prohibited investors, provided that such fees are Code; transactions); and to comply with the applied consistently and in like manner (8) The Risk Committee of UBS’s standards of prudence and loyalty set to all such investors; and Board of Directors is provided a copy of forth in section 404 of ERISA with (6) Not to include exculpatory the Audit Report; and a senior executive respect to each such ERISA-covered provisions disclaiming or otherwise officer of UBS’s Compliance and plan and IRA to the extent that section limiting liability of the UBS QPAM for Operational Risk Control function must 404 is applicable; a violation of such agreement’s terms. review the Audit Report for each UBS (2) To indemnify and hold harmless To the extent consistent with Section QPAM and must certify in writing, the Covered Plan for any actual losses 410 of ERISA, however, this provision under penalty of perjury, that such resulting directly from: A UBS QPAM’s does not prohibit disclaimers for officer has reviewed the Audit Report; violation of ERISA’s fiduciary duties, as liability caused by an error,

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misrepresentation, or misconduct of a amended, with the sole exception of the and Training and of the following: Any plan fiduciary or other party hired by violations of Section I(g) of PTE 84–14 compliance matter related to the the plan fiduciary who is independent that are attributable to the Convictions Policies or Training that was identified of UBS and its affiliates, or damages and the 2019 French Judgment Against by, or reported to, the Compliance arising from acts outside the control of UBS/UBS France. If, during the Officer or others within the C&ORC the UBS QPAM; Exemption Period, an entity within the function during the previous year; the (7) Within six months of the date of UBS corporate structure is convicted of most recent Audit Report issued the judgment against UBS or UBS a crime described in Section I(g) of PTE pursuant to this exemption or PTE France by the French First Instance 84–14, (other than the 2013 Conviction, 2017–07; any material change in the Court, each UBS QPAM must provide a 2018 Conviction, and the 2019 French relevant business activities of the UBS notice of its obligations under this Judgment Against UBS/UBS France), QPAMs; and any change to ERISA, the Section I(j) to each Covered Plan. For including a conviction in a foreign Code, or regulations related to fiduciary prospective Covered Plans that enter jurisdiction for a crime described in duties and the prohibited transaction into a written asset or investment Section I(g) of PTE 84–14, relief in this provisions that may be applicable to the management agreement with a UBS exemption would terminate activities of the UBS QPAMs; QPAM on or after the date of the immediately; (ii) The Compliance Officer prepares judgment, the UBS QPAM will agree to (m)(1) UBS continues to designate a a written report for the Exemption its obligations under this Section I(j) in senior compliance officer (the Review (an Exemption Report) that (A) an updated investment management Compliance Officer) who will be summarizes his or her material activities agreement between the UBS QPAM and responsible for compliance with the during the Exemption Period; (B) sets such clients or other written contractual Policies and Training requirements forth any instance of noncompliance agreement. This condition will be described herein. The Compliance discovered during the Exemption deemed met for each Covered Plan that Officer must conduct a review for the Period, and any related corrective received a notice pursuant to PTE 2016– Exemption Period (the Exemption action; (C) details any change to the 17 and/or PTE 2017–07 that meets the Review),16 to determine the adequacy Policies or Training to guard against any terms of this condition. and effectiveness of the implementation similar instance of noncompliance Notwithstanding the above, a UBS of the Policies and Training. With occurring again; and (D) makes QPAM will not violate the condition respect to the Compliance Officer, the recommendations, as necessary, for solely because a Plan or IRA refuses to following conditions must be met: additional training, procedures, sign an updated investment (i) The Compliance Officer must be a monitoring, or additional and/or management agreement. professional who has extensive changed processes or systems, and (k) Within 60 days of the judgment experience with, and knowledge of, the management’s actions on such against UBS or UBS France by the regulation of financial services and recommendations; French First Instance Court, each UBS products, including under ERISA and (iii) In the Exemption Report, the QPAM will provide a notice of the the Code; and Compliance Officer must certify in exemption, along with a separate (ii) The Compliance Officer must have writing that to the best of his or her summary describing the facts that led to a reporting line within UBS’s knowledge at the time: (A) The report is the Convictions and the 2019 French Compliance and Operational Risk accurate; (B) the Policies and Training Judgment Against UBS/UBS France (the Control (C&ORC) function to the Head are working in a manner which is Summary), which have been submitted of Compliance and Operational Risk reasonably designed to ensure that the Policies and Training requirements to the Department, and a prominently Control, Asset Management. The displayed statement (the Statement) described herein are met; (C) any known C&ORC function is organizationally (collectively, Initial Notice) that the instance of noncompliance during the independent of UBS’s business Convictions and, in the Department’s Exemption Period and any related divisions—including Asset view, the 2019 French Judgment Against correction taken to date have been Management, the Investment Bank, and UBS/UBS France, each separately result identified in the Exemption Report; and Global Wealth Management—and is led in a failure to meet a condition in PTE (D) the UBS QPAMs have complied by the head of Group Compliance, 84–14 and PTE 2017–07, to each with the Policies and Training, and/or Regulatory and Governance, or another sponsor and beneficial owner of a corrected (or are correcting) any known appropriate member of the Group Covered Plan, or the sponsor of an instances of noncompliance in Executive Board; investment fund in any case where a (2) With respect to the Exemption accordance with Section I(h) above; UBS QPAM acts as a sub-advisor to the (iv) The Exemption Report must be Review, the following conditions must investment fund in which such ERISA- provided to appropriate corporate be met: covered plan and IRA invests. Effective officers of UBS and each UBS QPAM to (i) The Exemption Review includes a as of the date that is 60 days after the which such report relates, and to the review of the UBS QPAMs’ compliance 2019 French Judgment Against UBS/ head of compliance and the General with and effectiveness of the Policies UBS France Date, all Covered Plan Counsel (or their functional equivalent) clients that enter into a written asset or of the relevant UBS QPAM; and the 16 Pursuant to PTE 2017–07 the Compliance investment management agreement with Officer must conduct an exemption review (annual report must be made unconditionally a UBS QPAM after that date must review) for each period corresponding to the audit available to the independent auditor receive a copy of the exemption, the periods set forth in Section I(i)(1) of PTE 2017–07 described in Section I(i) above; Summary, and the Statement prior to, or and the Compliance officer’s written report (v) The Exemption Review, including submitted to the Department within three (3) contemporaneously with, the Covered months of the end of the period to which it relates. the Compliance Officer’s written Plan’s receipt of a written asset Accordingly, the final exemption review pursuant Exemption Report, must be completed management agreement from the UBS to PTE 2017–07 must cover the period January 10, within three (3) months following the QPAM. Disclosures may be delivered 2018 through the date of the judgment against UBS end of the period to which it relates; or UBS France by the French First Instance Court, electronically; and the corresponding Compliance Officer’s written (n) UBS imposes its internal (l) The UBS QPAMs must comply report must be submitted within three (3) months procedures, controls, and protocols on with each condition of PTE 84–14, as of the judgment. UBS Securities Japan to: (1) Reduce the

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likelihood of any recurrence of conduct because a different UBS QPAM fails to (an ‘‘IRA’’), in each case, with respect to that that is the subject of the 2013 satisfy a condition for relief described in which a UBS QPAM relies on PTE 84– Conviction, and (2) comply in all Sections I(c), (d), (h), (i), (j), (k), (l), (p), 14, or with respect to which a UBS material respects with the Business or (r); or if the independent auditor QPAM (or any UBS affiliate) has Improvement Order, dated December described in Section I(i) fails a provision expressly represented that the manager 16, 2011, issued by the Japanese of the exemption other than the qualifies as a QPAM or relies on the Financial Services Authority; requirement described in Section QPAM class exemption (PTE 84–14). A (o) UBS complies in all material I(i)(11), provided that such failure did Covered Plan does not include an respects with the audit and monitoring not result from any actions or inactions ERISA-covered plan or IRA to the extent procedures imposed on UBS by the U.S. of UBS or its affiliates. the UBS QPAM has expressly Commodity Futures Trading Section II. Definitions disclaimed reliance on QPAM status or Commission Order, dated December 19, PTE 84–14 in entering into a contract, 2012; (a) The term ‘‘Convictions’’ means the arrangement, or agreement with the (p) Each UBS QPAM will maintain 2013 Conviction and the 2017 ERISA-covered plan or IRA. records necessary to demonstrate that Conviction. The term ‘‘2013 (d) The term ‘‘FX Misconduct’’ means the conditions of this exemption have Conviction’’ means the judgment of the conduct engaged in by UBS been met, for six (6) years following the conviction against UBS Securities Japan personnel described in Exhibit 1 of the date of any transaction for which such Co. Ltd. in case number 3:12–cr–00268– Plea Agreement (Factual Basis for UBS QPAM relies upon the relief in the RNC in the U.S. District Court for the Breach) entered into between UBS and exemption; District of Connecticut for one count of the Department of Justice Criminal (q) During the Exemption Period, UBS wire fraud in violation of Title 18, Division, on May 20, 2015 in connection must: (1) Immediately disclose to the United States Code, sections 1343 and 2 with Case Number 3:15–cr–00076–RNC Department any Deferred Prosecution in connection with submission of YEN filed in the U.S. District Court for the Agreement (a DPA) or Non-Prosecution London Interbank Offered Rates and District of Connecticut. Agreement (an NPA) with the U.S. other benchmark interest rates. The term (e) The term ‘‘UBS QPAM’’ means Department of Justice, entered into by ‘‘2018 Conviction’’ means the judgment UBS Asset Management (Americas) Inc., UBS or any of its affiliates (as defined of conviction against UBS in case UBS Realty Investors LLC, UBS Hedge in Section VI(d) of PTE 84–14) in number 3:15–cr–00076–RNC in the U.S. Fund Solutions LLC, UBS O’Connor connection with conduct described in District Court for the District of LLC, and any future entity within the Section I(g) of PTE 84–14 or section 411 Connecticut for one count of wire fraud Asset Management or the Global Wealth of ERISA; and (2) immediately provides in violation of Title 18, United States Management Americas U.S. divisions of the Department any information Code, Sections 1343 and 2 in UBS that qualifies as a ‘‘qualified requested by the Department, as connection with UBS’s submission of professional asset manager’’ (as defined permitted by law, regarding the Yen London Interbank Offered Rates in Section VI(a) of PTE 84–14) 18 and agreement and/or conduct and and other benchmark interest rates that relies on the relief provided by PTE allegations that led to the agreement; between 2001 and 2010. For all 84–14, and with respect to which UBS (r) Within six months from the date of purposes under this exemption, is an ‘‘affiliate’’ (as defined in Part VI(d) the judgment against UBS or UBS ‘‘conduct’’ of any person or entity that of PTE 84–14). The term ‘‘UBS QPAM’’ France by the French First Instance is the ‘‘subject of the Convictions’’ excludes UBS securities Japan, the Court, each UBS QPAM, in its encompasses any conduct of UBS and/ entity implicated in the criminal agreements with, or in other written or their personnel, that is described in conduct that is the subject of the 2013 disclosures provided to Covered Plans, (i) Exhibit 3 to the Plea Agreement Conviction, UBS, the entity implicated will clearly and prominently inform entered into between UBS and the in the criminal conduct that is the Covered Plan clients of their right to Department of Justice Criminal Division, subject of the 2018 Conviction and obtain a copy of the Policies or a on May 20, 2015, in connection with implicated in the criminal conduct of description (Summary Policies) which case number 3:15–cr–00076–RNC, and UBS and UBS France that is the subject accurately summarizes key components (ii) Exhibits 3 and 4 to the Plea of the 2019 French Judgment Against of the UBS QPAM’s written Policies Agreement entered into between UBS UBS/UBS France, and UBS France, the developed in connection with this Securities Japan and the Department of entity implicated in the criminal exemption. If the Policies are thereafter Justice Criminal Division, on December conduct of UBS and UBS France that is changed, each Covered Plan client must 19, 2012, in connection with case the subject of the 2019 French Judgment receive a new disclosure within six (6) number 3:12–cr–00268–RNC; Against UBS/UBS France. months following the end of the (b) The term ‘‘2019 French Judgment (f) The term ‘‘UBS’’ means UBS AG. calendar year during which the Policies Against UBS/UBS France’’ includes any (g) The term ‘‘UBS France’’ means 17 were changed. With respect to this adverse judgment against UBS or UBS ‘‘UBS (France) S.A.,’’ a wholly-owned requirement, the description may be France regarding case Number subsidiary of UBS incorporated under continuously maintained on a website, 1105592033. For all purposes under this the laws of France. provided that such website link to the exemption, ‘‘conduct’’ of any person or (h) The term ‘‘UBS Securities Japan’’ Policies or Summary Policies is clearly entity that is the ‘‘criminal conduct that means UBS Securities Japan Co. Ltd, a and prominently disclosed to each is the subject of the 2019 French wholly-owned subsidiary of UBS Covered Plan; and Judgment Against UBS/UBS France’’, incorporated under the laws of Japan. (s) A UBS QPAM will not fail to meet includes any conduct of UBS, its the terms of this exemption, solely affiliates, or UBS France and/or their 18 In general terms, a QPAM is an independent personnel that is described in any such fiduciary that is a bank, savings and loan 17 In the event the Applicant meets this disclosure judgment; association, insurance company, or investment requirement through Summary Policies, changes to (c) The term ‘‘Covered Plan’’ means a adviser that meets certain equity or net worth the Policies shall not result in the requirement for requirements and other licensure requirements and a new disclosure unless, as a result of changes to plan subject to Part IV of Title I of that has acknowledged in a written management the Policies, the Summary Policies are no longer ERISA (an ‘‘ERISA-covered plan’’) or a agreement that it is a fiduciary with respect to each accurate. plan subject to section 4975 of the Code plan that has retained the QPAM.

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(i) All references to ‘‘the date of the may be obtained free by contacting Secretary to determine to what extent, if judgment by the French First Instance Timothy Theberge, Office of Trade any, increased imports or shifts in either Court’’ refer to any judgment against Adjustment Assistance, Room N–5428, service or production have impacted the UBS or UBS France in case number Employment and Training petitioning worker group: 1105592033; Administration, U.S. Department of • ETA Form 9043a, Business Data (j) The term ‘‘Exemption Period’’ Labor, 200 Constitution Avenue NW, Request—Article means one year beginning on the date of Washington, DC 20210. Telephone • ETA Form 9043b, Business Data the French First Instance judgment number: 202–693–3401 (this is not a Request—Service against UBS or UBS France regarding toll-free number). Individuals with • ETA Form 9118, Business case Number 1105592033; hearing or speech impairments may Information Request (k) The term ‘‘Plea Agreement’’ means access the telephone number above via • ETA Form 8562a, Business the Plea Agreement (including Exhibits TTY by calling the toll-free Federal Customer Survey • 1 and 3 attached thereto) entered into Information Relay Service at 1–877– ETA Form 8562a1, Business Second between UBS and the Department of Tier Customer Survey 889–5627 (TTY/TDD). Fax: 202–693– • Justice Criminal Division, on May 20, 3584. Email: [email protected]. ETA Form 8562b, Business Bid 2015 in connection with Case Number A copy of the proposed information Survey 3:15–cr–00076–RNC filed in the US collection request (ICR) can be obtained This information collection is subject District Court for the District of by contacting the office listed above. to the PRA. A Federal agency generally cannot conduct or sponsor a collection Connecticut. Authority: 44 U.S.C. 3506(c)(2)(A). Effective Date: This exemption will be of information, and the public is in effect for one year from the date of SUPPLEMENTARY INFORMATION: DOL, as generally not required to respond to an the judgment in the French First part of continuing efforts to reduce information collection, unless it is Instance Court against UBS and/or UBS paperwork and respondent burden, approved by OMB under the PRA and France in case number 1105592033. conducts a pre-clearance consultation displays a currently valid OMB Control program to provide the general public Number. In addition, notwithstanding Signed at Washington, DC, this 21st day of and Federal agencies an opportunity to any other provisions of law, no person February, 2019. comment on proposed and/or Lyssa Hall, shall generally be subject to penalty for continuing collections of information failing to comply with a collection of Director, Office of Exemption Determinations before submitting them to the OMB for information that does not display a Employee Benefits Security Administration, final approval. This program helps to U.S. Department of Labor. valid Control Number. See 5 CFR ensure requested data can be provided [FR Doc. 2019–03339 Filed 2–22–19; 11:15 am] 1320.5(a) and 1320.6. in the desired format, reporting burden Interested parties are encouraged to BILLING CODE 4510–29–P (time and financial resources) is provide comments to the contact shown minimized, collection instruments are in the ADDRESSES section. Comments clearly understood, and the impact of DEPARTMENT OF LABOR must be written to receive collection requirements can be properly consideration, and they will be Employment and Training assessed. summarized and included in the request Administration Section 221(a) of Title II, Chapter 2 of for OMB approval of the final ICR. In the Trade Act of 1974, as amended by order to help ensure appropriate Agency Information Collection the Trade Adjustment Assistance consideration, comments should Activities; Comment Request; Petition Reauthorization Act of 2015, authorizes mention OMB control number 1205– Requirements and Investigative Data the Secretary of Labor and the Governor 0342. Collection: Trade Act of 1974, as of each state to accept petitions for Submitted comments will also be a Amended certification of eligibility to apply for matter of public record for this ICR and adjustment assistance. The petitions posted on the internet, without ACTION: Notice. may be filed by a group of workers, their redaction. DOL encourages commenters certified or recognized union or duly SUMMARY: The Department of Labor’s not to include personally identifiable authorized representative, employers of (DOL’s), Employment and Training information, confidential business data, such workers, one-stop operators, or Administration is soliciting comments or other sensitive statements/ one-stop partners. ETA Form 9042, concerning a proposed extension for the information in any comments. Petition for Trade Adjustment authority to conduct the information DOL is particularly interested in Assistance, and its Spanish translation, collection request (ICR) titled, ‘‘Petition comments that: ETA Form 9042A, Solicitud De • Requirements and Investigative Data Evaluate whether the proposed Asistencia Para Ajuste, establish a Collection: Trade Act of 1974, as collection of information is necessary format that may be used for filing such Amended.’’ This comment request is for the proper performance of the petitions. part of continuing Departmental efforts functions of the agency, including Sections 222, 223, and 249 of the whether the information will have to reduce paperwork and respondent Trade Act of 1974, as amended, require burden in accordance with the practical utility; the Secretary of Labor to issue a • Evaluate the accuracy of the Paperwork Reduction Act of 1995 determination for groups of workers as agency’s estimate of the burden of the (PRA). to their eligibility to apply for proposed collection of information, DATES: Consideration will be given to all adjustment assistance. After reviewing including the validity of the written comments received by April 29, all of the information obtained for each methodology and assumptions used; 2019. petition for Trade Adjustment • Enhance the quality, utility, and ADDRESSES: A copy of this ICR with Assistance filed with the Department, a clarity of the information to be applicable supporting documentation, determination is issued as to whether collected; and including a description of the likely the statutory criteria for certification are • Minimize the burden of the respondents, proposed frequency of met. The information collected via the collection of information on those who response, and estimated total burden, following forms will be used by the are to respond, including through the

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use of appropriate automated, International Labor Affairs, U.S. Schedule updates, including weather- electronic, mechanical, or other Department of Labor; Phone: (202) 693– related cancellations, are also available technological collection techniques or 4890. at www.ntsb.gov. other forms of information technology, SUPPLEMENTARY INFORMATION: The U.S. FOR MORE INFORMATION CONTACT: Candi e.g., permitting electronic submission of Department of Labor and the Office of Bing at (202) 314–6403 or by email at responses. the U.S. Trade Representative are co- [email protected]. Agency: DOL–ETA. sponsors of this Federal Advisory FOR MEDIA INFORMATION CONTACT: Keith Type of Review: Extension without Committee. The meeting will include a Holloway at (202) 314–6100 or by email changes. review and discussion of current issues at [email protected]. Title of Collection: Petition which influence U.S. trade policy. Dated: February 22, 2019. Requirements and Investigative Data Potential U.S. negotiating objectives and Collection: Trade Act of 1974, as bargaining positions in current and LaSean McCray, Amended. anticipated trade negotiations will be Assistant Federal Register Liaison Officer. Form(s): ETA 9042A, Petition for discussed. Pursuant to 19 U.S.C. [FR Doc. 2019–03456 Filed 2–22–19; 4:15 pm] Trade Adjustment Assistance, and its 2155(f)(2)(A), it has been determined BILLING CODE 7533–01–P Spanish translation ETA 9042A; ETA that the meeting will be concerned with 9043a, Business Data Request—Article; matters the disclosure of which would ETA 9043b, Business Data Request— seriously compromise the Government’s NUCLEAR REGULATORY Service; ETA 8562a, Business Customer negotiating objectives or bargaining COMMISSION Survey; ETA 85622a–1, Business positions. Therefore, the meeting is [Docket No. 40–8907; NRC–2019–0026] Second Tier Customer Survey; ETA– exempt from the requirements of 8562b, Business Bid Survey; and ETA subsections (a) and (b) of sections 10 United Nuclear Corporation (UNC) 9118, Business Information Request. and 11 of the Federal Advisory Church Rock Project; Correction OMB Control Number: 1205–0342. Committee Act (relating to open Affected Public: Individuals or meetings, public notice, public AGENCY: Nuclear Regulatory Households, Businesses, State participation, and public availability of Commission. Governments. documents). 5 U.S.C. app. Accordingly, ACTION: Intent to prepare an Estimated Number of Respondents: the meeting will be closed to the public. environmental impact statement (EIS) 5,280. Signed at Washington, DC. and conduct a scoping process; request Frequency: Once. for comment; correction. Total Estimated Annual Responses: Martha E. Newton, 5,460. Deputy Undersecretary, Bureau of SUMMARY: The U.S. Nuclear Regulatory Estimated Average Time per International Labor Affairs. Commission (NRC) is correcting a notice Response: 2.0805 Hours. [FR Doc. 2019–03307 Filed 2–25–19; 8:45 am] that was published in the Federal Estimated Total Annual Burden BILLING CODE 4510–28–P Register (FR) on February 8, 2019, Hours: 11,360. regarding UNC’s request to amend its Total Estimated Annual Other Cost license (SUA–1475) to excavate Burden: $0.00. NATIONAL TRANSPORTATION approximately 1 million cubic yards of SAFETY BOARD mine spoil from the Northeast Church Molly E. Conway, Rock Mine Site and dispose of it at the Acting Assistant Secretary for Employment Sunshine Act Meeting existing mill site in Church Rock, New and Training, Labor. Mexico. This action is necessary to TIME AND DATE: [FR Doc. 2019–03209 Filed 2–25–19; 8:45 am] 9:30 a.m., Tuesday, correct a document that was referenced BILLING CODE 4510–FN–P March 12, 2019. in the Background and Availability of PLACE: NTSB Conference Center, 429 Documents section as ‘‘ADAMS Package L’Enfant Plaza SW, Washington, DC Accession No. ML18360A424 DEPARTMENT OF LABOR 20594. (Package)’’ to read ‘‘ADAMS Accession STATUS: The one item is open to the Meeting of the Labor Advisory No. ML19007A126.’’ public. Committee for Trade Negotiation and DATES: February 26, 2019. Trade Policy MATTERS TO BE CONSIDERED: 58039 ADDRESSES: You may submit comments Aircraft Accident Report—Departure by any of the following methods: AGENCY: Bureau of International Labor From Controlled Flight Trans-Pacific • Federal Rulemaking website: Go to Affairs, U.S. Department of Labor, and Air Charter, LLC Learjet 35A, N452DA, http://www.regulations.gov and search Office of the United States Trade Teterboro, New Jersey, May 15, 2017. for Docket ID NRC–2019–0026. Address Representative. NEWS MEDIA CONTACT: Telephone: (202) questions about Docket IDs in ACTION: Meeting notice. 314–6100. Regulations.gov to Krupskaya Castellon; The press and public may enter the telephone: 301–287–9221; email: SUMMARY: Notice is hereby given of a NTSB Conference Center one hour prior [email protected]. For meeting of the Labor Advisory to the meeting for set up and seating. technical questions, contact the Committee for Trade Negotiation and Individuals requesting specific individual listed in the FOR FURTHER Trade Policy. accommodations should contact INFORMATION CONTACT section of this DATES: March 25, 2019, 10:30 a.m. to Rochelle McCallister at (202) 314–6305 document. 12:00 p.m.; U.S. Department of Labor, or by email at Rochelle.McCallister@ • Mail comments to: Office of Secretary’s Conference Room, 200 ntsb.gov by Wednesday, March 6, 2019. Administration, Mail Stop: TWFN–7– Constitution Ave. NW, Washington, DC. The public may view the meeting via A60M, U.S. Nuclear Regulatory FOR FURTHER INFORMATION CONTACT: a live or archived webcast by accessing Commission, Washington, DC 20555– Anne M. Zollner, Chief, Trade Policy a link under ‘‘News & Events’’ on the 0001, ATTN: Program Management, and Negotiations Division, Bureau of NTSB home page at www.ntsb.gov. Announcements and Editing Staff.

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• Email comments to: UNC- such amendment involves no significant (ADAMS): You may obtain publicly- [email protected] hazards consideration, notwithstanding available documents online in the For additional direction on obtaining the pendency before the Commission of ADAMS Public Documents collection at information and submitting comments, a request for a hearing from any person. http://www.nrc.gov/reading-rm/ see ‘‘Obtaining Information and This biweekly notice includes all adams.html. To begin the search, select Submitting Comments’’ in the notices of amendments issued, or ‘‘Begin Web-based ADAMS Search.’’ For SUPPLEMENTARY INFORMATION section of proposed to be issued, from January 29, problems with ADAMS, please contact this document. 2019, to February 11, 2019. The last the NRC’s Public Document Room (PDR) FOR FURTHER INFORMATION CONTACT: biweekly notice was published on reference staff at 1–800–397–4209, 301– Ashley Waldron, Office of Nuclear February 12, 2019. 415–4737, or by email to pdr.resource@ Material Safety and Safeguards, U.S. DATES: Comments must be filed by nrc.gov. The ADAMS accession number Nuclear Regulatory Commission, March 28, 2019. A request for a hearing for each document referenced (if it is Washington, DC 20555–0001; telephone: must be filed by April 29, 2019. available in ADAMS) is provided the 301–415–7317; email: Ashley.Waldron@ Comments received after this date will first time that it is mentioned in this nrc.gov. be considered if it is practical to do so, document • SUPPLEMENTARY INFORMATION: In the FR but the Commission is able to ensure NRC’s PDR: You may examine and on February 8, 2019, in FR Doc. 2019– consideration only for comments purchase copies of public documents at 01642, on page 2935, in the third received before this date. the NRC’s PDR, Room O1–F21, One column, under the last paragraph, last ADDRESSES: You may submit comments White Flint North, 11555 Rockville line in Section II, ‘‘Background,’’ correct by any of the following methods: Pike, Rockville, Maryland 20852. • Federal Rulemaking Website: Go to ‘‘ADAMS Package Accession No. B. Submitting Comments ML18360A424’’ to read ‘‘ADAMS http://www.regulations.gov and search Accession No. ML19007A126.’’ The for Docket ID INSERT: NRC–2019–0058. Please include Docket ID NRC–2019– document is also referenced in the last Address questions about Docket IDs in 0058, facility name, unit number(s), line of the Document table in Section Regulations.gov to Krupskaya Castellon; plant docket number, application date, VII, Availability of Documents, correct telephone: 301–287–9221; email: and subject in your comment ‘‘ML18360A424 (Package)’’ to read [email protected]. For submission. ‘‘ML19007A126.’’ technical questions, contact the The NRC cautions you not to include individual(s) listed in the FOR FURTHER identifying or contact information that Dated at Rockville, Maryland, on February INFORMATION CONTACT section of this 21, 2019. you do not want to be publicly document. disclosed in your comment submission. For the U.S. Nuclear Regulatory • Mail comments to: Office of Commission. The NRC will post all comment Administration, Mail Stop: TWFN–7– submissions at http:// Michael F. King, A60M, U.S. Nuclear Regulatory www.regulations.gov as well as enter the Director, Division of Fuel Cycle Safety, Commission, Washington, DC 20555– comment submissions into ADAMS. Safeguards, and Environmental Review, 0001, ATTN: Program Management, The NRC does not routinely edit Office of Nuclear Material Safety, and Announcements and Editing Staff. Safeguards. comment submissions to remove For additional direction on obtaining identifying or contact information. [FR Doc. 2019–03300 Filed 2–25–19; 8:45 am] information and submitting comments, If you are requesting or aggregating BILLING CODE 7590–01–P see ‘‘Obtaining Information and comments from other persons for Submitting Comments’’ in the submission to the NRC, then you should SUPPLEMENTARY INFORMATION section of inform those persons not to include NUCLEAR REGULATORY this document. COMMISSION identifying or contact information that FOR FURTHER INFORMATION CONTACT: they do not want to be publicly [NRC–2019–0058] Lynn Ronewicz, Office of Nuclear disclosed in their comment submission. Reactor Regulation, U.S. Nuclear Your request should state that the NRC Biweekly Notice; Applications and Regulatory Commission, Washington DC does not routinely edit comment Amendments To Facility Operating 20555–0001; telephone: 301–415–1927, submissions to remove such information Licenses and Combined Licenses email: [email protected]. before making the comment Involving No Significant Hazards SUPPLEMENTARY INFORMATION: submissions available to the public or Considerations I. Obtaining Information and entering the comment into ADAMS. AGENCY: Nuclear Regulatory Submitting Comments II. Background Commission. A. Obtaining Information ACTION: Biweekly notice. Pursuant to Section 189a.(2) of the Please refer to Docket ID INSERT: Atomic Energy Act of 1954, as amended SUMMARY: Pursuant to the Atomic NRC–2019–0058, facility name, unit (the Act), the U.S. Nuclear Regulatory Energy Act of 1954, as amended (the number(s), plant docket number, Commission (NRC) is publishing this Act), the U.S. Nuclear Regulatory application date, and subject when regular biweekly notice. The Act Commission (NRC) is publishing this contacting the NRC about the requires the Commission to publish regular biweekly notice. The Act availability of information for this notice of any amendments issued, or requires the Commission to publish action. You may obtain publicly- proposed to be issued, and grants the notice of any amendments issued, or available information related to this Commission the authority to issue and proposed to be issued, and grants the action by any of the following methods: make immediately effective any Commission the authority to issue and • Federal Rulemaking Website: Go to amendment to an operating license or make immediately effective any http://www.regulations.gov and search combined license, as applicable, upon a amendment to an operating license or for Docket ID INSERT: NRC–2019–0058. determination by the Commission that combined license, as applicable, upon a • NRC’s Agencywide Documents such amendment involves no significant determination by the Commission that Access and Management System hazards consideration, notwithstanding

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the pendency before the Commission of for a hearing and petition for leave to limitations in the order granting leave to a request for a hearing from any person. intervene (petition) with respect to the intervene. Parties have the opportunity action. Petitions shall be filed in to participate fully in the conduct of the III. Notice of Consideration of Issuance accordance with the Commission’s hearing with respect to resolution of of Amendments to Facility Operating ‘‘Agency Rules of Practice and that party’s admitted contentions, Licenses and Combined Licenses and Procedure’’ in 10 CFR part 2. Interested including the opportunity to present Proposed No Significant Hazards persons should consult a current copy evidence, consistent with the NRC’s Consideration Determination of 10 CFR 2.309. The NRC’s regulations regulations, policies, and procedures. The Commission has made a are accessible electronically from the Petitions must be filed no later than proposed determination that the NRC Library on the NRC’s website at 60 days from the date of publication of following amendment requests involve http://www.nrc.gov/reading-rm/doc- this notice. Petitions and motions for no significant hazards consideration. collections/cfr/. Alternatively, a copy of leave to file new or amended Under the Commission’s regulations in the regulations is available at the NRC’s contentions that are filed after the § 50.92 of title 10 of the Code of Federal Public Document Room, located at One deadline will not be entertained absent Regulations (10 CFR), this means that White Flint North, Room O1–F21, 11555 a determination by the presiding officer operation of the facility in accordance Rockville Pike (first floor), Rockville, that the filing demonstrates good cause with the proposed amendment would Maryland 20852. If a petition is filed, by satisfying the three factors in 10 CFR not (1) involve a significant increase in the Commission or a presiding officer 2.309(c)(1)(i) through (iii). The petition the probability or consequences of an will rule on the petition and, if must be filed in accordance with the accident previously evaluated; or (2) appropriate, a notice of a hearing will be filing instructions in the ‘‘Electronic create the possibility of a new or issued. Submissions (E-Filing)’’ section of this different kind of accident from any As required by 10 CFR 2.309(d) the document. accident previously evaluated; or (3) petition should specifically explain the If a hearing is requested, and the involve a significant reduction in a reasons why intervention should be Commission has not made a final margin of safety. The basis for this permitted with particular reference to determination on the issue of no proposed determination for each the following general requirements for significant hazards consideration, the amendment request is shown below. standing: (1) The name, address, and Commission will make a final The Commission is seeking public telephone number of the petitioner; (2) determination on the issue of no comments on this proposed the nature of the petitioner’s right under significant hazards consideration. The determination. Any comments received the Act to be made a party to the final determination will serve to within 30 days after the date of proceeding; (3) the nature and extent of establish when the hearing is held. If the publication of this notice will be the petitioner’s property, financial, or final determination is that the considered in making any final other interest in the proceeding; and (4) amendment request involves no determination. the possible effect of any decision or significant hazards consideration, the Normally, the Commission will not order which may be entered in the Commission may issue the amendment issue the amendment until the proceeding on the petitioner’s interest. and make it immediately effective, expiration of 60 days after the date of In accordance with 10 CFR 2.309(f), notwithstanding the request for a publication of this notice. The the petition must also set forth the hearing. Any hearing would take place Commission may issue the license specific contentions which the after issuance of the amendment. If the amendment before expiration of the 60- petitioner seeks to have litigated in the final determination is that the day period provided that its final proceeding. Each contention must amendment request involves a determination is that the amendment consist of a specific statement of the significant hazards consideration, then involves no significant hazards issue of law or fact to be raised or any hearing held would take place consideration. In addition, the controverted. In addition, the petitioner before the issuance of the amendment Commission may issue the amendment must provide a brief explanation of the unless the Commission finds an prior to the expiration of the 30-day bases for the contention and a concise imminent danger to the health or safety comment period if circumstances statement of the alleged facts or expert of the public, in which case it will issue change during the 30-day comment opinion which support the contention an appropriate order or rule under 10 period such that failure to act in a and on which the petitioner intends to CFR part 2. timely way would result, for example in rely in proving the contention at the A State, local governmental body, derating or shutdown of the facility. If hearing. The petitioner must also Federally-recognized Indian Tribe, or the Commission takes action prior to the provide references to the specific agency thereof, may submit a petition to expiration of either the comment period sources and documents on which the the Commission to participate as a party or the notice period, it will publish in petitioner intends to rely to support its under 10 CFR 2.309(h)(1). The petition the Federal Register a notice of position on the issue. The petition must should state the nature and extent of the issuance. If the Commission makes a include sufficient information to show petitioner’s interest in the proceeding. final no significant hazards that a genuine dispute exists with the The petition should be submitted to the consideration determination, any applicant or licensee on a material issue Commission no later than 60 days from hearing will take place after issuance. of law or fact. Contentions must be the date of publication of this notice. The Commission expects that the need limited to matters within the scope of The petition must be filed in accordance to take this action will occur very the proceeding. The contention must be with the filing instructions in the infrequently. one which, if proven, would entitle the ‘‘Electronic Submissions (E-Filing)’’ petitioner to relief. A petitioner who section of this document, and should A. Opportunity To Request a Hearing fails to satisfy the requirements at 10 meet the requirements for petitions set and Petition for Leave To Intervene CFR 2.309(f) with respect to at least one forth in this section, except that under Within 60 days after the date of contention will not be permitted to 10 CFR 2.309(h)(2) a State, local publication of this notice, any persons participate as a party. governmental body, or Federally- (petitioner) whose interest may be Those permitted to intervene become recognized Indian Tribe, or agency affected by this action may file a request parties to the proceeding, subject to any thereof does not need to address the

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standing requirements in 10 CFR is participating; and (2) advise the exemption request, in accordance with 2.309(d) if the facility is located within Secretary that the participant will be 10 CFR 2.302(g), with their initial paper its boundaries. Alternatively, a State, submitting a petition or other filing stating why there is good cause for local governmental body, Federally- adjudicatory document (even in not filing electronically and requesting recognized Indian Tribe, or agency instances in which the participant, or its authorization to continue to submit thereof may participate as a non-party counsel or representative, already holds documents in paper format. Such filings under 10 CFR 2.315(c). an NRC-issued digital ID certificate). must be submitted by: (1) First class If a hearing is granted, any person Based upon this information, the mail addressed to the Office of the who is not a party to the proceeding and Secretary will establish an electronic Secretary of the Commission, U.S. is not affiliated with or represented by docket for the hearing in this proceeding Nuclear Regulatory Commission, a party may, at the discretion of the if the Secretary has not already Washington, DC 20555–0001, Attention: presiding officer, be permitted to make established an electronic docket. Rulemaking and Adjudications Staff; or a limited appearance pursuant to the Information about applying for a (2) courier, express mail, or expedited provisions of 10 CFR 2.315(a). A person digital ID certificate is available on the delivery service to the Office of the making a limited appearance may make NRC’s public website at http:// Secretary, 11555 Rockville Pike, an oral or written statement of his or her www.nrc.gov/site-help/e-submittals/ Rockville, Maryland 20852, Attention: position on the issues but may not getting-started.html. Once a participant Rulemaking and Adjudications Staff. otherwise participate in the proceeding. has obtained a digital ID certificate and Participants filing adjudicatory A limited appearance may be made at a docket has been created, the documents in this manner are any session of the hearing or at any participant can then submit responsible for serving the document on prehearing conference, subject to the adjudicatory documents. Submissions all other participants. Filing is limits and conditions as may be must be in Portable Document Format considered complete by first-class mail imposed by the presiding officer. Details (PDF). Additional guidance on PDF as of the time of deposit in the mail, or regarding the opportunity to make a submissions is available on the NRC’s by courier, express mail, or expedited limited appearance will be provided by public website at http://www.nrc.gov/ delivery service upon depositing the the presiding officer if such sessions are site-help/electronic-sub-ref-mat.html. A document with the provider of the scheduled. filing is considered complete at the time service. A presiding officer, having the document is submitted through the B. Electronic Submissions (E-Filing) granted an exemption request from NRC’s E-Filing system. To be timely, an using E-Filing, may require a participant All documents filed in NRC electronic filing must be submitted to or party to use E-Filing if the presiding adjudicatory proceedings, including a the E-Filing system no later than 11:59 officer subsequently determines that the request for hearing and petition for p.m. Eastern Time on the due date. reason for granting the exemption from leave to intervene (petition), any motion Upon receipt of a transmission, the E- use of E-Filing no longer exists. or other document filed in the Filing system time-stamps the document Documents submitted in adjudicatory proceeding prior to the submission of a and sends the submitter an email notice proceedings will appear in the NRC’s request for hearing or petition to confirming receipt of the document. The electronic hearing docket which is intervene, and documents filed by E-Filing system also distributes an email available to the public at https:// interested governmental entities that notice that provides access to the adams.nrc.gov/ehd, unless excluded request to participate under 10 CFR document to the NRC’s Office of the pursuant to an order of the Commission 2.315(c), must be filed in accordance General Counsel and any others who or the presiding officer. If you do not with the NRC’s E-Filing rule (72 FR have advised the Office of the Secretary have an NRC-issued digital ID certificate 49139; August 28, 2007, as amended at that they wish to participate in the as described above, click ‘‘Cancel’’ 77 FR 46562; August 3, 2012). The E- proceeding, so that the filer need not when the link requests certificates and Filing process requires participants to serve the document on those you will be automatically directed to the submit and serve all adjudicatory participants separately. Therefore, NRC’s electronic hearing dockets where documents over the internet, or in some applicants and other participants (or you will be able to access any publicly cases to mail copies on electronic their counsel or representative) must available documents in a particular storage media. Detailed guidance on apply for and receive a digital ID hearing docket. Participants are making electronic submissions may be certificate before adjudicatory requested not to include personal found in the Guidance for Electronic documents are filed so that they can privacy information, such as social Submissions to the NRC and on the NRC obtain access to the documents via the security numbers, home addresses, or website at http://www.nrc.gov/site-help/ E-Filing system. personal phone numbers in their filings, e-submittals.html. Participants may not A person filing electronically using unless an NRC regulation or other law submit paper copies of their filings the NRC’s adjudicatory E-Filing system requires submission of such unless they seek an exemption in may seek assistance by contacting the information. For example, in some accordance with the procedures NRC’s Electronic Filing Help Desk instances, individuals provide home described below. through the ‘‘Contact Us’’ link located addresses in order to demonstrate To comply with the procedural on the NRC’s public website at http:// proximity to a facility or site. With requirements of E-Filing, at least 10 www.nrc.gov/site-help/e- respect to copyrighted works, except for days prior to the filing deadline, the submittals.html, by email to limited excerpts that serve the purpose participant should contact the Office of [email protected], or by a toll- of the adjudicatory filings and would the Secretary by email at free call at 1–866–672–7640. The NRC constitute a Fair Use application, [email protected], or by telephone Electronic Filing Help Desk is available participants are requested not to include at 301–415–1677, to (1) request a digital between 9 a.m. and 6 p.m., Eastern copyrighted materials in their identification (ID) certificate, which Time, Monday through Friday, submission. allows the participant (or its counsel or excluding government holidays. For further details with respect to representative) to digitally sign Participants who believe that they these license amendment applications, submissions and access the E-Filing have a good cause for not submitting see the application for amendment system for any proceeding in which it documents electronically must file an which is available for public inspection

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in ADAMS and at the NRC’s PDR. For The proposed change does not involve a reactor building sump and the actions to be additional direction on accessing physical alteration to the plant (i.e., no new taken when the reactor building sump is information related to this document, or different type of equipment will be inoperable with the exception of adding new see the ‘‘Obtaining Information and installed) or a change to the methods actions to be taken when the reactor building governing normal plant operation. sump is inoperable due to reactor building Submitting Comments’’ section of this Furthermore, the change does not alter the accident generated and transported debris document. assumptions made in the safety analysis. exceeding the analyzed limits. The new Duke Energy Progress, LLC, Docket Nos. Therefore, the proposed change does not action provides time to evaluate and correct the condition instead of requiring an 50–325 and 50–324, Brunswick Steam create the possibility of a new or different kind of accident from any accident immediate plant shutdown. Electric Plant, Units 1 and 2, Brunswick previously evaluated. The reactor building sump is not an County, North Carolina 3. Does the proposed change involve a initiator of any accident previously Date of amendment request: significant reduction in a margin of safety? evaluated. The reactor building sump is a Response: No. passive component and the proposed change December 14, 2018. A publicly-available does not increase the likelihood of the version is in ADAMS under Accession The proposed change will not affect operation of plant equipment or the function malfunction. As a result, the probability of an No. ML18353A951. accident is unaffected by the proposed Description of amendment request: of any equipment assumed in the accident analysis. Affected containment penetrations change. The amendments would modify will continue to be isolated as required by The reactor building sump is used to requirements for repetitive verification the existing TSs. Therefore, the proposed mitigate accidents previously evaluated by of the status of locked, sealed, or change does not involve a significant providing a borated water source for the Emergency Core Cooling System (ECCS) and secured components to allow the reduction in safety margin. verification to be done by use of Reactor Building Spray (RBS) System. The The NRC staff has reviewed the design of the reactor building sump and the administrative means consistent with licensee’s analysis and, based on this capability of the reactor building sump Technical Specifications Task Force review, it appears that the three assumed in the accident analysis is not (TSTF) Traveler 269, Revision 2, ‘‘Allow standards of 10 CFR 50.92(c) are changed. The proposed action requires Administrative Means of Position implementation of mitigating actions while satisfied. Therefore, the NRC staff Verification for Locked or Sealed the reactor building sump is inoperable and proposes to determine that the Valves.’’ more frequent monitoring of reactor coolant Basis for proposed no significant amendment request involves no leakage to detect any increased potential for hazards consideration determination: significant hazards consideration. an accident that would require the reactor Attorney for licensee: Kathryn B. building sump. The consequences of an As required by 10 CFR 50.91(a), the accident during the proposed action are no licensee has provided its analysis of the Nolan, Deputy General Counsel, Duke Energy Corporation, 550 South Tryon different than the current consequences of an issue of no significant hazards accident if the reactor building sump is Street, Mail Code DEC45A, Charlotte, consideration, which is presented inoperable. below: NC 28202. The proposed change clarifies the SFDP [Safety Function Determination Program] 1. Does the proposed change involve a Entergy Operations, Inc., Docket No. 50– 313, Arkansas Nuclear One, Unit 1 when a supported system is made inoperable significant increase in the probability or by the inoperability of a single TS support consequences of an accident previously (ANO–1), Pope County, Arkansas system. The SFDP directs the appropriate use evaluated? Date of amendment request: of TS actions and the proposed change does Response: No. not alter the current intent of the TS. The The proposed change modifies Technical December 19, 2018. A publicly-available version is in ADAMS under Accession actions taken when a system is inoperable are Specification (TS) 3.6.1.3, ‘‘Primary not an assumption in the initiation or Containment Isolation Valves (PCIVs)’’ and No. ML18353B044. mitigation of any previously evaluated TS 3.6.4.2, ‘‘Secondary Containment Description of amendment request: accident. Isolation Dampers (SCIDs).’’ These The amendment would revise the ANO– Therefore, the proposed change does not specifications require penetration flow paths 1 Technical Specifications (TSs) to involve a significant increase in the with inoperable isolation devices be isolated adopt Technical Specifications Task probability or consequences of an accident and periodically verified to be isolated. Force (TSTF) Traveler TSTF–567, previously evaluated. Consistent with TSTF–269–A, Revision 2, 2. Does the proposed amendment create notes are proposed to be added to TS 3.6.1.3, Revision 1, ‘‘Add Containment Sump TS to Address GSI [Generic Safety the possibility of a new or different kind of Required Actions A.2 and C.2, and TS accident from any accident previously 3.6.4.2, Required Action A.2, to allow Issue]–191 Issues.’’ evaluated? isolation devices that are locked, sealed, or Basis for proposed no significant Response: No. otherwise secured to be verified using hazards consideration determination: The proposed change adds a new administrative means. As required by 10 CFR 50.91(a), the specification to the TS for the reactor The proposed change does not affect any licensee has provided its analysis of the building sump. An existing SR on the reactor plant equipment, test methods, or plant issue of no significant hazards building sump is moved to the new operation, and is not an initiator of any consideration, which is presented specification and a duplicative requirement analyzed accident sequence. The inoperable below: to perform the SR in TS 3.5.3 is removed. containment penetrations will continue to be The new specification retains the existing isolated, and hence perform their isolation 1. Does the proposed amendment involve requirements on the reactor building sump function. Operation in accordance with the a significant increase in the probability or and the actions to be taken when the reactor proposed TSs will ensure that all analyzed consequences of an accident previously building sump is inoperable with the accidents will continue to be mitigated as evaluated? exception of adding new actions to be taken previously analyzed. Therefore, the proposed Response: No. when the reactor building sump is inoperable change does not involve a significant The proposed change adds a new due to reactor building accident generated increase in the probability or consequences specification to the TS for the reactor and transported debris exceeding the of an accident previously evaluated. building sump. An existing SR [surveillance analyzed limits. The new action provides 2. Does the proposed change create the requirement] on the reactor building sump is time to evaluate and correct the condition possibility of a new or different kind of moved to the new specification and a instead of requiring an immediate plant accident from any accident previously duplicative requirement to perform the SR in shutdown. evaluated? TS 3.5.3 is removed. The new specification The proposed change does not alter the Response: No. retains the existing requirements on the design or design function of the reactor

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building sump or the plant. No new systems Susquehanna Nuclear, LLC, Docket Nos. Additionally, Susquehanna proposes an are installed or removed as part of the 50–387 and 50–388, Susquehanna administrative change to remove the TOC proposed change. The reactor building sump Steam Electric Station, Units 1 and 2, from the TS and place it under licensee is a passive component and cannot initiate a Luzerne County, Pennsylvania control. This has no impact on the design or malfunction or accident. No new credible operation of the plant and cannot impact the accident is created that is not encompassed Date of amendment request: January probability of an accident in any way. by the existing accident analyses that assume 9, 2019. A publicly-available version is Therefore, the proposed change does not involve a significant increase in the the function of the reactor building sump. in ADAMS under Accession No. probability or consequences of an accident The proposed change clarifies the SFDP ML19009A431. previously evaluated. when a supported system is made inoperable Description of amendment request: by the inoperability of a single TS support The amendments would temporarily 2. Does the proposed change create the system. The SFDP directs the appropriate use change Technical Specification (TS) TS possibility of a new or different kind of of TS actions and the proposed change does 3.7.1, ‘‘Residual Heat Removal Service accident from any accident previously not alter the current intent of the TS. The Water (RHRSW) System and the evaluated? Response: No. proposed change to the Safety Function Ultimate Heat Sink (UHS),’’ and TS The proposed change is to permit a Determination Program will not result in any 3.7.2, ‘‘Emergency Service Water (ESW) temporary extension to existing TS change to the design or design function of the System,’’ to allow one division of the Completion Times to allow for ESW system reactor building sump or a method of ESW and RHRSW systems to be piping replacement. The change does not operation of the plant. inoperable for a total of 14 days to involve a physical alteration of the plant (i.e., Therefore, the proposed change does not address piping degradation. The no different equipment will be installed) or create the possibility of a new or different amendments would also remove the a change in the methods governing normal kind of accident from any accident Table of Contents (TOC) from the TSs plant operations. The proposed change does previously evaluated. and place it under licensee control. not alter assumptions made in the safety 3. Does the proposed amendment involve analysis. During the replacement evolution, Basis for proposed no significant one division of the ESW and RHRSW systems a significant reduction in a margin of safety? hazards consideration determination: Response: No. will not be capable of performing their safety As required by 10 CFR 50.91(a), the The proposed change adds a new function. However, the other division of ESW specification to the TS for the reactor licensee has provided its analysis of the and RHRSW are capable of providing the building sump. An existing SR on the reactor issue of no significant hazards necessary cooling in the event of an accident. building sump is moved to the new consideration, which is presented Furthermore, the ability to perform the safety function for the impacted division can specification and a duplicative requirement below: always be recovered within the existing TS to perform the SR in TS 3.5.3 is removed. 1. Does the proposed change involve a Completion Times and the systems will be The new specification retains the existing significant increase in the probability or fully restored to OPERABLE status following requirements on the reactor building sump consequences of an accident previously the pipe replacement. The proposed change and the actions to be taken when the reactor evaluated? does not introduce new failure mechanisms, building sump is inoperable with the Response: No. malfunctions, or accident initiators not exception of adding new actions to be taken The proposed change is to permit a considered in the design and licensing basis. when the reactor building sump is inoperable temporary extension to existing TS Additionally, Susquehanna proposes an due to reactor building accident generated Completion Times to allow for ESW system administrative change to remove the TOC and transported debris exceeding the piping replacement. The division of the ESW from the TS and place it under licensee analyzed limits. The new action provides and RHRSW systems that are not being control. This has no impact on the design or worked on will remain fully OPERABLE time to evaluate and correct the condition operation of the plant and cannot create a during the 14 day Completion Time. instead of requiring an immediate plant new or different kind of accident. Although it would not be able to be restored shutdown. Therefore, the proposed change does not to a fully OPERABLE status, the impacted The proposed change does not affect the create the possibility of a new or different division of ESW and RHRSW will be capable kind of accident from any accident controlling values of parameters used to of being restored to perform its safety avoid exceeding regulatory or licensing previously evaluated. function within the limiting 72 hour 3. Does the proposed change involve a limits. No Safety Limits are affected by the Completion Time. The ESW and RHRSW proposed change. The proposed change does significant reduction in a margin of safety? systems and their supported equipment Response: No. not affect any assumptions in the accident function as accident mitigators. Removing analyses that demonstrate compliance with The proposed change is to permit a one division from service for a limited period temporary extension to existing TS regulatory and licensing requirements. of time does not affect any accident initiator Completion Times to allow for ESW system Therefore, the proposed change does not and, therefore, cannot change the probability piping replacement. The proposed change involve a significant reduction in a margin of of an accident. The proposed changes and the does not alter the manner in which safety safety. ESW repair evolution have been evaluated to limits, limiting safety settings, or limiting assess their impact on the systems affected conditions for operation are determined. The The NRC staff has reviewed the and ensure design basis safety functions are licensee’s analysis and, based on this safety analysis assumptions and acceptance preserved. There is a slight increase in risk criteria are not affected by this change. The review, it appears that the three associated with having the ESW and RHRSW change will ultimately result in an increase standards of 10 CFR 50.92(c) are systems and their supported systems out of in a margin of safety due to installation of the satisfied. Therefore, the NRC staff service for longer than currently allowed by new piping. proposes to determine that the the SSES [Susquehanna] TS. However, Additionally, Susquehanna proposes an amendment request involves no Susquehanna will maintain the non- administrative change to remove the TOC significant hazards consideration. impacted division of ESW and RHRSW fully from the TS and place it under licensee OPERABLE throughout the repair evolution control. This has no impact on the design or Attorney for licensee: Anna Vinson and will protect required equipment in operation of the plant and cannot impact any Jones, Senior Counsel, Entergy Services, accordance with its protected equipment safety margins. Inc., 101 Constitution Avenue NW, program. The non-impacted division is Therefore, the proposed change does not Suite 200 East, L–ENT–WDC, capable of serving 100 percent of the heat involve a significant reduction in a margin of Washington, DC 20001. loads for both the online and outage units safety. during an accident. As such, there is no NRC Branch Chief: Robert J. impact on consequence mitigation for any The NRC staff has reviewed the Pascarelli. transient or accident. licensee’s analysis and, based on this

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review, it appears that the three Indiana Michigan Power Company, Cavity and Spent Fuel Pool Cooling standards of 10 CFR 50.92(c) are Docket Nos. 50–315 and 50–316, Donald System (SFS) Isolation. Additional satisfied. Therefore, the NRC staff C. Cook Nuclear Plant, Unit Nos. 1 and changes added TS operability proposes to determine that the 2, Berrien County, Michigan requirements for the SFS containment amendment request involves no Date of amendment request: isolation valves in MODES 5 and 6. Date of issuance: January 15, 2019. significant hazards consideration. September 5, 2018. Effective date: As of the date of Brief description of amendments: The Attorney for licensee: Damon D. Obie, issuance and shall be implemented amendments revised the Donald C. Cook Associate General Counsel, Talen within 30 days of issuance. Energy Supply, LLC, 835 Hamilton St., Nuclear Plant, Unit Nos. 1 and 2, Amendment Nos.: 150 (Unit 3) and Suite 150, Allentown, PA 18101. Technical Specification 5.5.15, ‘‘Battery 149 (Unit 4). A publicly-available Monitoring and Maintenance Program,’’ NRC Branch Chief: James G. Danna. version is in ADAMS under Package to align with the latest Institute of Accession No. ML18351A189; IV. Notice of Issuance of Amendments Electrical and Electronics Engineers documents related to these amendments to Facility Operating Licenses and (IEEE) Standard (Std.) for maintenance are listed in the Safety Evaluation Combined Licenses and testing of the safety-related enclosed with the amendments. batteries. Specifically, the amendments Facility Combined License Nos. NPF– During the period since publication of replaced all the references of the IEEE 91 and NPF–92: The amendments the last biweekly notice, the Std. 450–1995, ‘‘IEEE Recommended revised the facility Combined Licenses. Commission has issued the following Practice for Maintenance, Testing, and Date of initial notice in Federal amendments. The Commission has Replacement of Vented Lead-Acid Register: September 11, 2018 (83 FR determined for each of these Batteries for Stationary Applications,’’ 45986). The supplement dated amendments that the application with the updated IEEE Std. 450–2010, as December 3, 2018, provided additional complies with the standards and endorsed, with certain regulatory information that clarified the requirements of the Atomic Energy Act positions, in Regulatory Guide 1.129, application, did not expand the scope of of 1954, as amended (the Act), and the Revision 3, ‘‘Seismic Design the application as originally noticed, Commission’s rules and regulations. Classification.’’ and did not change the NRC staff’s The Commission has made appropriate Date of issuance: February 5, 2019. original proposed no significant hazards findings as required by the Act and the Effective date: As of the date of consideration determination. Commission’s rules and regulations in issuance and shall be implemented The Commission’s related evaluation within 90 days of issuance. 10 CFR chapter I, which are set forth in of the amendments is contained in a Amendment Nos.: 343 (Unit No. 1) the license amendment. Safety Evaluation dated January 15, and 325 (Unit No. 2). A publicly- 2019. A notice of consideration of issuance available version is in ADAMS under No significant hazards consideration of amendment to facility operating Accession No. ML18346A358; comments received: No. license or combined license, as documents related to these amendments applicable, proposed no significant are listed in the Safety Evaluation Southern Nuclear Operating Company, hazards consideration determination, enclosed with the amendments. Docket Nos. 52–025 and 52–026, Vogtle and opportunity for a hearing in Facility Operating License Nos. DPR– Electric Generating Plant, Units 3 and 4, connection with these actions, was 58 and DPR–74: The amendments Burke County, Georgia published in the Federal Register as revised the Renewed Facility Operating Date of amendment request: August indicated. Licenses and Technical Specifications. 10, 2018. Date of initial notice in Federal Brief description of amendments: The Unless otherwise indicated, the Register: November 6, 2018 (83 FR amendments consisted of changes to Commission has determined that these 55574). Combined License Appendix A, amendments satisfy the criteria for The Commission’s related evaluation Technical Specifications (TSs), and categorical exclusion in accordance of the amendments is contained in a revised TS Limiting Condition for with 10 CFR 51.22. Therefore, pursuant Safety Evaluation dated February 5, Operation (LCO) 3.1.8, ‘‘Physics Tests to 10 CFR 51.22(b), no environmental 2019. Exception—Mode 2,’’ to include impact statement or environmental No significant hazards consideration Function 4 as one of the LCO 3.3.1, assessment need be prepared for these comments received: No. ‘‘Reactor Trip System (RTS) amendments. If the Commission has Instrumentation,’’ functions where the Southern Nuclear Operating Company, prepared an environmental assessment number of required channels may be Docket Nos. 52–025 and 52–026, Vogtle under the special circumstances reduced to three during the performance Electric Generating Plant, Units 3 and 4, provision in 10 CFR 51.22(b) and has of physics tests. Additionally, LCO Burke County, Georgia made a determination based on that 3.8.3, ‘‘Inverters—Operating,’’ was assessment, it is so indicated. Date of amendment request: July 20, revised to make an editorial 2018, as supplemented by letter dated For further details with respect to the nomenclature change from ‘‘constant December 3, 2018. action see (1) the applications for voltage source transformer’’ to ‘‘voltage Brief description of amendments: The amendment, (2) the amendment, and (3) regulating transformer.’’ amendments consisted of changes to Date of issuance: January 30, 2019. the Commission’s related letter, Safety Combined License Appendix A, Effective date: As of the date of Evaluation and/or Environmental Technical Specifications (TSs), and issuance and shall be implemented Assessment as indicated. All of these revised operability requirements for the within 30 days of issuance. items can be accessed as described in Engineered Safety Feature Actuation Amendment Nos.: 153 (Unit 3) and the ‘‘Obtaining Information and System Spent Fuel Pool Level—Low 2 152 (Unit 4). A publicly-available Submitting Comments’’ section of this and In-Containment Refueling Water version is in ADAMS under Package document. Storage Tank Wide Range Level—Low Accession No. ML18354B207; instrumentation functions for Refueling documents related to these amendments

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are listed in the Safety Evaluation V. Notice of Issuance of Amendments to days, the Commission may provide an enclosed with the amendments. Facility Operating Licenses and opportunity for public comment. If Facility Combined Licenses Nos. NPF– Combined Licenses and Final comments have been requested, it is so 91 and NPF–92: The amendments Determination of No Significant stated. In either event, the State has revised the facility Combined Licenses. Hazards Consideration and been consulted by telephone whenever Opportunity for a Hearing (Exigent possible. Date of initial notice in Federal Public Announcement or Emergency Under its regulations, the Commission Register: September 25, 2018 (83 FR Circumstances) may issue and make an amendment 48467). During the period since publication of immediately effective, notwithstanding The Commission’s related evaluation the last biweekly notice, the the pendency before it of a request for of the amendments is contained in a Commission has issued the following a hearing from any person, in advance Safety Evaluation dated January 30, amendments. The Commission has of the holding and completion of any 2019. determined for each of these required hearing, where it has determined that no significant hazards No significant hazards consideration amendments that the application for the amendment complies with the consideration is involved. comments received: No. The Commission has applied the standards and requirements of the standards of 10 CFR 50.92 and has made Tennessee Valley Authority, Docket Atomic Energy Act of 1954, as amended a final determination that the Nos. 50–390 and 50–391, Watts Bar (the Act), and the Commission’s rules amendment involves no significant Nuclear Plant, Units 1 and 2 (Watts and regulations. The Commission has hazards consideration. The basis for this Bar), Rhea County, Tennessee made appropriate findings as required determination is contained in the by the Act and the Commission’s rules documents related to this action. Date of amendment request: January and regulations in 10 CFR chapter I, Accordingly, the amendments have 5, 2018. which are set forth in the license been issued and made effective as amendment. Brief description of amendments: The indicated. Because of exigent or emergency amendments revised Technical Unless otherwise indicated, the circumstances associated with the date Specification (TS) 3.6.3, ‘‘Containment Commission has determined that these the amendment was needed, there was Isolation Valves,’’ and Surveillance amendments satisfy the criteria for not time for the Commission to publish, Requirement 3.6.3.5 to change the categorical exclusion in accordance for public comment before issuance, its frequency in accordance with the Watts with 10 CFR 51.22. Therefore, pursuant usual notice of consideration of Bar Containment Leakage Rate Testing to 10 CFR 51.22(b), no environmental issuance of amendment, proposed no Program, which is described in TS impact statement or environmental significant hazards consideration 5.7.2.19. The changes allow leak rate assessment need be prepared for these determination, and opportunity for a testing of the containment purge system amendments. If the Commission has hearing. prepared an environmental assessment containment isolation valves to be For exigent circumstances, the under the special circumstances performed at least once every 30 Commission has either issued a Federal provision in 10 CFR 51.12(b) and has months, as prescribed in Regulatory Register notice providing opportunity made a determination based on that Guide 1.163, ‘‘Performance-Based for public comment or has used local Containment Leak-Test Program.’’ assessment, it is so indicated. media to provide notice to the public in For further details with respect to the Date of issuance: January 28, 2019. the area surrounding a licensee’s facility action see (1) The application for Effective date: As of the date of of the licensee’s application and of the amendment, (2) the amendment to issuance and shall be implemented Commission’s proposed determination Facility Operating License or Combined within 30 days of issuance. of no significant hazards consideration. License, as applicable, and (3) the The Commission has provided a Amendment Nos.: 123 (Unit 1) and 24 Commission’s related letter, Safety reasonable opportunity for the public to Evaluation and/or Environmental (Unit 2). A publicly-available version is comment, using its best efforts to make in ADAMS under Accession No. Assessment, as indicated. All of these available to the public means of items can be accessed as described in ML18327A005; documents related to communication for the public to the ‘‘Obtaining Information and these amendments are listed in the respond quickly, and in the case of Submitting Comments’’ section of this Safety Evaluation enclosed with the telephone comments, the comments document. amendments. have been recorded or transcribed as Facility Operating License Nos. NPF– appropriate and the licensee has been Northern States Power Company— 90 and NPF–96: The amendments informed of the public comments. Minnesota, Docket No. 50–306, Prairie In circumstances where failure to act Island Nuclear Generating Plant, Unit 2, revised the Facility Operating Licenses in a timely way would have resulted, for Goodhue County, Minnesota and TSs. example, in derating or shutdown of a Date of amendment request: January Date of initial notice in Federal nuclear power plant or in prevention of 29, 2019. Register: March 13, 2018 (83 FR either resumption of operation or of Description of amendment: The 10924). increase in power output up to the amendment revised Technical The Commission’s related evaluation plant’s licensed power level, the Specification 3.8.1, Condition E, to of the amendments is contained in a Commission may not have had an allow a one-time extension to the Safety Evaluation dated January 28, opportunity to provide for public completion time for two diesel 2019. comment on its no significant hazards generators out of service. consideration determination. In such Date of issuance: January 29, 2019. No significant hazards consideration case, the license amendment has been Effective date: January 29, 2019. comments received: No. issued without opportunity for Amendment No: 213. A publicly- comment. If there has been some time available version is in ADAMS under for public comment but less than 30 Accession No. ML19029A094;

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documents related to this amendment Week of March 18, 2019—Tentative Dated at Rockville, Maryland, this 21st day are listed in the Safety Evaluation of February, 2019. Wednesday, March 20, 2019 enclosed with the amendment. For the Nuclear Regulatory Commission. Renewed Facility Operating License 10:00 a.m. Meeting with the Denise L. McGovern, No. DPR–60: The amendment revised Organization of Agreement States Policy Coordinator, Office of the Secretary. the Renewed Facility Operating License and the Conference of Radiation [FR Doc. 2019–03337 Filed 2–22–19; 11:15 am] and Technical Specifications. Control Program Directors (Public), BILLING CODE 7590–01–P Public comments requested as to (Contact: Paul Michalak: 301–415– proposed no significant hazards 5804) consideration: No. This meeting will be webcast live at POSTAL SERVICE the Web address—http://www.nrc.gov/. The Commission’s related evaluation of the amendment, finding of emergency Week of March 25, 2019—Tentative Temporary Emergency Committee of the Board of Governors; Sunshine Act circumstances, State consultation, and Thursday, March 28, 2019 final no significant hazards Meeting consideration determination are 9:00 a.m. Transformation at the NRC: Innovation (Public Meeting), DATES AND TIMES: Monday, March 4, contained in a Safety Evaluation dated 2019, at 9:30 a.m. January 29, 2019. (Contact: June Cai: 301–415–1771) PLACE: Washington, DC. Attorney for licensee: Peter M. Glass, This meeting will be webcast live at STATUS: Assistant General Counsel, Xcel Energy the Web address—http://www.nrc.gov/. Closed. Services, Inc., 414 Nicollet Mall, Week of April 1, 2019—Tentative MATTERS TO BE CONSIDERED: Minneapolis, MN 55401. Thursday, April 4, 2019 Monday, March 4, 2019, at 9:30 a.m. NRC Branch Chief: David J. Wrona. 10:00 a.m. Meeting with the Advisory 1. Strategic Items. Dated at Rockville, Maryland, this 15th day 2. Administrative Matters. of February, 2019. Committee on the Medical Uses of Isotopes (Public Meeting), (Contact: GENERAL COUNSEL CERTIFICATION: The For the Nuclear Regulatory Commission. Kellee Jamerson: 301–415–7408) General Counsel of the United States Craig G. Erlanger, Postal Service has certified that the Additional Information: The meeting Director, Division of Operating Reactor meeting may be closed under the scheduled on March 28, 2019 at 9:00 Licensing, Office of Nuclear Reactor Government in the Sunshine Act. Regulation. a.m., Transformation at the NRC: CONTACT PERSON FOR MORE INFORMATION: [FR Doc. 2019–02934 Filed 2–25–19; 8:45 am] Innovation, was postponed from the originally scheduled date of January 31, Michael J. Elston, Acting Secretary of BILLING CODE 7590–01–P 2019. the Board, U.S. Postal Service, 475 L’Enfant Plaza SW, Washington, DC CONTACT PERSON FOR MORE INFORMATION: 20260–1000. Telephone: (202) 268– For more information or to verify the NUCLEAR REGULATORY 4800. COMMISSION status of meetings, contact Denise McGovern at 301–415–0681 or via email Michael J. Elston, [NRC–2019–0001] at [email protected]. The Acting Secretary. schedule for Commission meetings is [FR Doc. 2019–03460 Filed 2–22–19; 4:15 pm] Sunshine Act Meetings subject to change on short notice. BILLING CODE 7710–12–P The NRC Commission Meeting TIME AND DATE: Weeks of February 25, Schedule can be found on the internet March 4, 11, 18, 25, April 1, 2019. at: http://www.nrc.gov/public-involve/ SECURITIES AND EXCHANGE public-meetings/schedule.html. PLACE: Commissioners’ Conference COMMISSION The NRC provides reasonable Room, 11555 Rockville Pike, Rockville, [Investment Company Act Release No. Maryland. accommodation to individuals with disabilities where appropriate. If you 33379; 812–14881] STATUS: Public and Closed. need a reasonable accommodation to Monteagle Funds and Nashville Capital MATTERS TO BE CONSIDERED: participate in these public meetings, or Corporation need this meeting notice or the Week of February 18, 2019 transcript or other information from the February 21, 2019. There are no meetings scheduled for public meetings in another format (e.g., AGENCY: Securities and Exchange the week of February 18, 2019. Braille, large print), please notify Commission (‘‘Commission’’). Kimberly Meyer-Chambers, NRC ACTION: Notice. Week of February 25, 2019—Tentative Disability Program Manager, at 301– There are no meetings scheduled for 287–0739, by videophone at 240–428– Notice of an application under section the week of February 25, 2019. 3217, or by email at Kimberly.Meyer- 6(c) of the Investment Company Act of [email protected]. Determinations on 1940 (‘‘Act’’) for an exemption from Week of March 4, 2019—Tentative requests for reasonable accommodation section 15(a) of the Act and rule 18f–2 Tuesday, March 5, 2019 will be made on a case-by-case basis. under the Act, as well as from certain Members of the public may request to disclosure requirements in rule 20a–1 10:00 a.m. Briefing on NRC receive this information electronically. under the Act, Item 19(a)(3) of Form N– International Activities (Closed— If you would like to be added to the 1A, Items 22(c)(1)(ii), 22(c)(1)(iii), Ex. 1 & 9) distribution, please contact the Nuclear 22(c)(8) and 22(c)(9) of Schedule 14A Week of March 11, 2019—Tentative Regulatory Commission, Office of the under the Securities Exchange Act of Secretary, Washington, DC 20555, (301– 1934, and sections 6–07(2)(a), (b), and There are no meetings scheduled for 415–1969), or by email at (c) of Regulation S–X (‘‘Disclosure the week of March 11, 2019. [email protected]. Requirements’’). The requested

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exemption would permit an investment Summary of the Application other than Affiliated Subadvisers. For adviser to hire and replace certain 1. The Adviser will serve as the any Fund that employs an Affiliated subadvisers without shareholder investment adviser to the Funds Subadviser, the Fund will provide approval and grant relief from the pursuant to an investment advisory separate disclosure of any fees paid to Disclosure Requirements as they relate agreement with the Trust (the ‘‘Advisory the Affiliated Subadviser. to fees paid to the subadvisers. Agreement’’).1 The Adviser will provide 3. Applicants agree that any order Applicants: Monteagle Funds (the each Fund with overall investment granting the requested relief will be ‘‘Trust’’), a Delaware statutory trust management services and will subject to the terms and conditions registered under the Act as an open-end continuously review, supervise and stated in the application. Such terms management investment company, and administer each Fund’s investment and conditions provide for, among other Nashville Capital Corporation (the program, subject to the supervision of, safeguards, appropriate disclosure to ‘‘Adviser’’), a Tennessee corporation and policies established by, each Fund’s Fund shareholders and notification registered as an investment adviser board of trustees (‘‘Board’’). The about subadvisory changes and under the Investment Advisers Act of Advisory Agreement permits the enhanced Board oversight to protect the 1940 (collectively with the Trust, the Adviser, subject to the approval of the interests of the Funds’ shareholders. ‘‘Applicants’’). Board, to delegate to one or more 4. Section 6(c) of the Act provides that the Commission may exempt any Filing Dates: The application was subadvisers (each, a ‘‘Subadviser’’ and person, security, or transaction or any filed on February 27, 2018 and amended collectively, the ‘‘Subadvisers’’) the class or classes of persons, securities, or on June 11, 2018, October 23, 2018, and responsibility to provide the day-to-day transactions from any provisions of the December 21, 2018. portfolio investment management of each Fund, subject to the supervision Act, or any rule thereunder, if such Hearing or Notification of Hearing: An and direction of the Adviser.2 The relief is necessary or appropriate in the order granting the application will be primary responsibility for managing the public interest and consistent with the issued unless the Commission orders a Funds will remain vested in the protection of investors and purposes hearing. Interested persons may request Adviser. The Adviser will hire, fairly intended by the policy and a hearing by writing to the evaluate, allocate assets to and oversee provisions of the Act. Applicants Commission’s Secretary and serving the Subadvisers, including determining believe that the requested relief meets applicants with a copy of the request, whether a Subadviser should be this standard because, as further personally or by mail. terminated, at all times subject to the explained in the application, the Hearing requests should be received authority of the Board. Advisory Agreements will remain by the Commission by 5:30 p.m. on 2. Applicants request an exemption to subject to shareholder approval while March 18, 2019, and should be permit the Adviser, subject to Board the role of the Subadvisers is accompanied by proof of service on the approval, to hire certain Subadvisers substantially similar to that of Applicants, in the form of an affidavit pursuant to subadvisory agreements and individual portfolio managers, so that or, for lawyers, a certificate of service. materially amend existing subadvisory requiring shareholder approval of Pursuant to rule 0–5 under the Act, agreements without obtaining the subadvisory agreements would impose hearing requests should state the nature shareholder approval required under unnecessary delays and expenses on the of the writer’s interest, any facts bearing section 15(a) of the Act and rule 18f–2 Funds. Applicants believe that the upon the desirability of a hearing on the under the Act.3 Applicants also seek an requested relief from the Disclosure matter, the reason for the request, and exemption from the Disclosure Requirements meets this standard the issues contested. Persons who wish Requirements to permit a Fund to because it will improve the Adviser’s to be notified of a hearing may request disclose (as both a dollar amount and a ability to negotiate fees paid to the notification by writing to the percentage of the Fund’s net assets): (a) Subadvisers that are more advantageous Commission’s Secretary. The aggregate fees paid to the Adviser for the Funds. ADDRESSES: Secretary, U.S. Securities and any Affiliated Subadviser; and (b) For the Commission, by the Division of and Exchange Commission, 100 F Street the aggregate fees paid to Subadvisers Investment Management, under delegated NE, Washington, DC 20549–1090. authority. Applicants: Monteagle Funds, 8000 1 Applicants request relief with respect to any Eduardo A. Aleman, existing or future series of the Trust or any other Town Centre Drive, Suite 400, registered open-end management company that: (a) Deputy Secretary. Broadview Heights, OH 44147; Is advised by the Adviser, or any person [FR Doc. 2019–03311 Filed 2–25–19; 8:45 am] Nashville Capital Corporation, 2506 controlling, controlled by or under common control BILLING CODE 8011–01–P Winford Avenue, Nashville, TN 37211. with the Adviser or its successors (each, an ‘‘Adviser’’); (b) uses the manager of managers FOR FURTHER INFORMATION CONTACT: structure described in the application; and (c) SECURITIES AND EXCHANGE Zeena Abdul-Rahman, Senior Counsel, complies with the terms and conditions of the requested order (any such series, a ‘‘Fund’’ and COMMISSION at (202) 551–4099, or Andrea collectively, the ‘‘Funds’’). For purposes of the Ottomanelli Magovern, Branch Chief, at requested order, ‘‘successor’’ is limited to an entity [Investment Company Act Release No. (202) 551–6821 (Division of Investment that results from a reorganization into another 33380; 812–14954] Management, Chief Counsel’s Office). jurisdiction or a change in the type of business organization. Acquirers Funds, LLC, et al. SUPPLEMENTARY INFORMATION: The 2 The Trust currently has six series. The Adviser following is a summary of the has hired a Subadviser for each of these Funds in February 21, 2019. compliance with section 15(a) of the Act. application. The complete application 3 The requested relief will not extend to any AGENCY: Securities and Exchange may be obtained via the Commission’s Subadviser that is an affiliated person, as defined Commission (‘‘Commission’’). website by searching for the file in section 2(a)(3) of the Act, of the Trust, a Fund, ACTION: Notice. number, or an applicant using the or the Adviser, other than solely by reason of serving as a Subadviser to one or more of the Funds, Company name box, at http:// or as an adviser or subadviser to any series of the Notice of an application for an order www.sec.gov/search/search.htm or by Trust other than the Funds (‘‘Affiliated under section 6(c) of the Investment calling (202) 551–8090. Subadviser’’). Company Act of 1940 (the ‘‘Act’’) for an

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exemption from sections 2(a)(32), ADDRESSES: Secretary, Securities and (‘‘Affiliated Person’’), or an affiliated 5(a)(1), 22(d), and 22(e) of the Act and Exchange Commission, 100 F Street NE, person of an Affiliated Person (‘‘Second- rule 22c–1 under the Act, under Washington, DC 20549–1090; Tier Affiliate’’), of the Trust or a Fund, sections 6(c) and 17(b) of the Act for an Applicants: Acquirers Funds, LLC, 415 of the Adviser, of any sub-adviser to or exemption from sections 17(a)(1) and North Camden Drive, Suite 223, Beverly promoter of a Fund, or of the Distributor 17(a)(2) of the Act, and under section Hills, CA 90210; ETF Series Solutions, will compile, create, sponsor or 12(d)(1)(J) for an exemption from 615 East Michigan Street, Milwaukee, maintain the Underlying Index.2 sections 12(d)(1)(A) and 12(d)(1)(B) of Wisconsin 53202; Quasar Distributors, 3. Shares will be purchased and the Act. The requested order would LLC, 777 East Wisconsin Avenue, 6th redeemed in Creation Units and permit (a) index-based series of certain Floor, Milwaukee, Wisconsin 53202. generally on an in-kind basis. Except open-end management investment FOR FURTHER INFORMATION CONTACT: where the purchase or redemption will companies (‘‘Funds’’) to issue shares Christine Y. Greenlees, Senior Counsel, include cash under the limited redeemable in large aggregations only at (202) 551–6990, or Andrea circumstances specified in the (‘‘Creation Units’’); (b) secondary market Ottomanelli Magovern, Branch Chief, at application, purchasers will be required transactions in Fund shares to occur at (202) 551–6821 (Division of Investment to purchase Creation Units by negotiated market prices rather than at Management, Chief Counsel’s Office). depositing specified instruments net asset value (‘‘NAV’’); (c) certain SUPPLEMENTARY INFORMATION: The (‘‘Deposit Instruments’’), and Funds to pay redemption proceeds, following is a summary of the shareholders redeeming their shares under certain circumstances, more than application. The complete application will receive specified instruments seven days after the tender of shares for may be obtained via the Commission’s (‘‘Redemption Instruments’’). The redemption; (d) certain affiliated website by searching for the file Deposit Instruments and the persons of a Fund to deposit securities number, or for an applicant using the Redemption Instruments will each into, and receive securities from, the Company name box, at http:// correspond pro rata to the positions in Fund in connection with the purchase www.sec.gov/search/search.htm or by the Fund’s portfolio (including cash and redemption of Creation Units; and calling (202) 551–8090. positions) except as specified in the (e) certain registered management application. investment companies and unit Summary of the Application 4. Because shares will not be investment trusts outside of the same 1. Applicants request an order that individually redeemable, applicants group of investment companies as the would allow Funds to operate as index request an exemption from section Funds (‘‘Funds of Funds’’) to acquire exchange traded funds (‘‘ETFs’’).1 Fund 5(a)(1) and section 2(a)(32) of the Act shares of the Funds. shares will be purchased and redeemed that would permit the Funds to register Applicants: Acquirers Funds, LLC at their NAV in Creation Units only. All as open-end management investment (the ‘‘Initial Adviser’’), a California orders to purchase Creation Units and companies and issue shares that are limited liability company that is all redemption requests will be placed redeemable in Creation Units only. registered as an investment adviser by or through an ‘‘Authorized 5. Applicants also request an under the Investment Advisers Act of Participant’’, which will have signed a exemption from section 22(d) of the Act 1940, ETF Series Solutions (the participant agreement with the and rule 22c–1 under the Act as ‘‘Trust’’), a Delaware statutory trust secondary market trading in shares will registered under the Act as an open-end Distributor. Shares will be listed and traded individually on a national take place at negotiated prices, not at a management investment company with current offering price described in a multiple series, and Quasar Distributors, securities exchange, where share prices will be based on the current bid/offer Fund’s prospectus, and not at a price LLC, a Delaware limited liability based on NAV. Applicants state that (a) company and broker-dealer registered market. Any order granting the requested relief would be subject to the secondary market trading in shares does under the Securities Exchange Act of not involve a Fund as a party and will 1934 (‘‘Exchange Act’’). terms and conditions stated in the application. not result in dilution of an investment Filing Dates: The application was in shares, and (b) to the extent different filed on September 17, 2018. 2. Each Fund will hold investment positions selected to correspond prices exist during a given trading day, Hearing or Notification of Hearing: An or from day to day, such variances occur order granting the requested relief will generally to the performance of an Underlying Index. In the case of Self- as a result of third-party market forces, be issued unless the Commission orders such as supply and demand. Therefore, a hearing. Interested persons may Indexing Funds, an affiliated person, as defined in section 2(a)(3) of the Act applicants assert that secondary market request a hearing by writing to the transactions in shares will not lead to Commission’s Secretary and serving 1 discrimination or preferential treatment applicants with a copy of the request, Applicants request that the order apply to The among purchasers. Finally, applicants personally or by mail. Hearing requests Acquirers Fund (the ‘‘Initial Fund’’), a new series of the Trust, and any additional series of the Trust, represent that share market prices will should be received by the Commission and any other open-end management investment be disciplined by arbitrage by 5:30 p.m. on March 18, 2019 and company or series thereof (‘‘Future Funds’’ and opportunities, which should prevent should be accompanied by proof of together with the Initial Fund, ‘‘Funds’’), each of shares from trading at a material service on applicants, in the form of an which will operate as an ETF and will track a specified index comprised of domestic and/or discount or premium from NAV. affidavit, or for lawyers, a certificate of foreign equity securities and/or domestic and/or 6. With respect to Funds that effect service. Pursuant to rule 0–5 under the foreign fixed income securities (each, an creations and redemptions of Creation Act, hearing requests should state the ‘‘Underlying Index’’). Each Fund will (a) be advised by the Initial Adviser or an entity controlling, nature of the writer’s interest, any facts controlled by, or under common control with the 2 Each Self-Indexing Fund will post on its website bearing upon the desirability of a Initial Adviser (each such entity and any successor the identities and quantities of the investment hearing on the matter, the reason for the thereto, an ‘‘Adviser’’) and (b) comply with the positions that will form the basis for the Fund’s request, and the issues contested. terms and conditions of the application. For calculation of its NAV at the end of the day. purposes of the requested order, ‘‘successor’’ is Applicants believe that requiring Self-Indexing Persons who wish to be notified of a limited to an entity that results from a Funds to maintain full portfolio transparency will hearing may request notification by reorganization into another jurisdiction or a change help address, together with other protections, writing to the Commission’s Secretary. in the type of business organization. conflicts of interest with respect to such Funds.

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Units in kind and that are based on Fund of Funds directly from a Fund will open-end management investment certain Underlying Indexes that include be accomplished in accordance with the companies (‘‘Funds’’) to issue shares foreign securities, applicants request policies of the Fund of Funds and will redeemable in large aggregations relief from the requirement imposed by be based on the NAVs of the Funds. (‘‘Creation Units’’); (b) secondary market section 22(e) in order to allow such 9. Section 6(c) of the Act permits the transactions in Fund shares to occur at Funds to pay redemption proceeds Commission to exempt any persons or negotiated market prices rather than at within fifteen calendar days following transactions from any provision of the net asset value (‘‘NAV’’); (c) certain the tender of Creation Units for Act if such exemption is necessary or Funds to pay redemption proceeds, redemption. Applicants assert that the appropriate in the public interest and under certain circumstances, more than requested relief would not be consistent with the protection of seven days after the tender of shares for inconsistent with the spirit and intent of investors and the purposes fairly redemption; (d) certain affiliated section 22(e) to prevent unreasonable, intended by the policy and provisions of persons of a Fund to deposit securities undisclosed or unforeseen delays in the the Act. Section 12(d)(1)(J) of the Act into, and receive securities from, the actual payment of redemption proceeds. provides that the Commission may Fund in connection with the purchase 7. Applicants request an exemption to exempt any person, security, or and redemption of Creation Units; (e) permit Funds of Funds to acquire Fund transaction, or any class or classes of certain registered management shares beyond the limits of section persons, securities, or transactions, from investment companies and unit 12(d)(1)(A) of the Act; and the Funds, any provision of section 12(d)(1) if the investment trusts outside of the same and any principal underwriter for the exemption is consistent with the public group of investment companies as the Funds, and/or any broker or dealer interest and the protection of investors. Funds (‘‘Funds of Funds’’) to acquire registered under the Exchange Act, to Section 17(b) of the Act authorizes the shares of the Funds; and (f) certain sell shares to Funds of Funds beyond Commission to grant an order Funds to issue Shares in less than the limits of section 12(d)(1)(B) of the permitting a transaction otherwise Creation Unit size to investors Act. The application’s terms and prohibited by section 17(a) if it finds participating in a distribution conditions are designed to, among other that (a) the terms of the proposed reinvestment program. things, help prevent any potential (i) transaction are fair and reasonable and Applicants: Tidal ETF Trust (the undue influence over a Fund through do not involve overreaching on the part ‘‘Trust’’), a Delaware statutory trust, control or voting power, or in of any person concerned; (b) the which will register with the connection with certain services, proposed transaction is consistent with Commission as a series open-end transactions, and underwritings, (ii) the policies of each registered management investment company, and excessive layering of fees, and (iii) investment company involved; and (c) Toroso Investments, LLC (the ‘‘Initial overly complex fund structures, which the proposed transaction is consistent Adviser’’), a Delaware limited liability are the concerns underlying the limits with the general purposes of the Act. company registered as an investment in sections 12(d)(1)(A) and (B) of the For the Commission, by the Division of adviser under the Investment Advisers Act. Act of 1940. 8. Applicants request an exemption Investment Management, under delegated authority. Filing Dates: The application was from sections 17(a)(1) and 17(a)(2) of the filed on August 9, 2018 and amended on Act to permit persons that are Affiliated Eduardo A. Aleman, Deputy Secretary. December 4, 2018. Persons, or Second-Tier Affiliates, of the Hearing or Notification of Hearing: An Funds, solely by virtue of certain [FR Doc. 2019–03310 Filed 2–25–19; 8:45 am] order granting the requested relief will ownership interests, to effectuate BILLING CODE 8011–01–P be issued unless the Commission orders purchases and redemptions in-kind. The a hearing. Interested persons may deposit procedures for in-kind SECURITIES AND EXCHANGE request a hearing by writing to the purchases of Creation Units and the Commission’s Secretary and serving redemption procedures for in-kind COMMISSION applicants with a copy of the request, redemptions of Creation Units will be [Investment Company Act Release No. personally or by mail. Hearing requests the same for all purchases and 33378; 812–14939] should be received by the Commission redemptions and Deposit Instruments by 5:30 p.m. on March 18, 2019 and and Redemption Instruments will be Toroso Investments, LLC and Tidal should be accompanied by proof of valued in the same manner as those ETF Trust service on applicants, in the form of an investment positions currently held by affidavit, or for lawyers, a certificate of the Funds. Applicants also seek relief February 21, 2019 service. Pursuant to rule 0–5 under the from the prohibitions on affiliated AGENCY: Securities and Exchange Act, hearing requests should state the transactions in section 17(a) to permit a Commission (‘‘Commission’’). nature of the writer’s interest, any facts Fund to sell its shares to and redeem its ACTION: Notice. shares from a Fund of Funds, and to bearing upon the desirability of a engage in the accompanying in-kind Notice of an application for an order hearing on the matter, the reason for the transactions with the Fund of Funds.3 under section 6(c) of the Investment request, and the issues contested. The purchase of Creation Units by a Company Act of 1940 (the ‘‘Act’’) for an Persons who wish to be notified of a exemption from sections 2(a)(32), hearing may request notification by 3 The requested relief would apply to direct sales 5(a)(1), 22(d), and 22(e) of the Act and writing to the Commission’s Secretary. of shares in Creation Units by a Fund to a Fund of rule 22c–1 under the Act, under ADDRESSES: Secretary, Securities and Funds and redemptions of those shares. Applicants Exchange Commission, 100 F Street NE, are not seeking relief from section 17(a) for, and the sections 6(c) and 17(b) of the Act for an requested relief will not apply to, transactions exemption from sections 17(a)(1) and Washington, DC 20549–1090; where a Fund could be deemed an Affiliated 17(a)(2) of the Act, and under section Applicants: The Trust and the Initial Person, or a Second-Tier Affiliate, of a Fund of 12(d)(1)(J) for an exemption from Adviser, 898 N Broadway, Suite 2, Funds because an Adviser or an entity controlling, Massapequa, New York 11758. controlled by or under common control with an sections 12(d)(1)(A) and 12(d)(1)(B) of Adviser provides investment advisory services to the Act. The requested order would FOR FURTHER INFORMATION CONTACT: that Fund of Funds. permit (a) index-based series of certain Benjamin Kalish, Attorney-Adviser, at

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(202) 551–7361, or Parisa Haghshenas, 3. Shares will be purchased and the tender of Creation Units for Branch Chief, at (202) 551–6723 redeemed in Creation Units and redemption. Applicants assert that the (Division of Investment Management, generally on an in-kind basis, or issued requested relief would not be Chief Counsel’s Office). in less than Creation Unit size to inconsistent with the spirit and intent of SUPPLEMENTARY INFORMATION: The investors participating in a distribution section 22(e) to prevent unreasonable, following is a summary of the reinvestment program. Except where the undisclosed or unforeseen delays in the application. The complete application purchase or redemption will include actual payment of redemption proceeds. may be obtained via the Commission’s cash under the limited circumstances 7. Applicants request an exemption to website by searching for the file specified in the application, purchasers permit Funds of Funds to acquire Fund number, or for an applicant using the will be required to purchase Creation shares beyond the limits of section Company name box, at http:// Units by depositing specified 12(d)(1)(A) of the Act; and the Funds, www.sec.gov/search/search.htm or by instruments (‘‘Deposit Instruments’’), and any principal underwriter for the calling (202) 551–8090. and shareholders redeeming their shares Funds, and/or any broker or dealer will receive specified instruments registered under the Exchange Act, to Summary of the Application (‘‘Redemption Instruments’’). The sell shares to Funds of Funds beyond 1. Applicants request an order that Deposit Instruments and the the limits of section 12(d)(1)(B) of the would allow Funds to operate as index Redemption Instruments will each Act. The application’s terms and exchange traded funds (‘‘ETFs’’).1 Fund correspond pro rata to the positions in conditions are designed to, among other shares will be purchased and redeemed the Fund’s portfolio (including cash things, help prevent any potential (i) at their NAV in Creation Units (other positions) except as specified in the undue influence over a Fund through than pursuant to a distribution application. control or voting power, or in reinvestment program, as described in 4. Because shares will not be connection with certain services, the application). All orders to purchase individually redeemable, applicants transactions, and underwritings, (ii) Creation Units and all redemption request an exemption from section excessive layering of fees, and (iii) requests will be placed by or through an 5(a)(1) and section 2(a)(32) of the Act overly complex fund structures, which ‘‘Authorized Participant,’’ which will that would permit the Funds to register are the concerns underlying the limits have signed a participant agreement as open-end management investment in sections 12(d)(1)(A) and (B) of the with the distributor. Shares will be companies and issue shares that are Act. listed and traded individually on a redeemable in Creation Units (other 8. Applicants request an exemption national securities exchange, where than pursuant to a distribution from sections 17(a)(1) and 17(a)(2) of the share prices will be based on the current reinvestment program). Act to permit persons that are Affiliated bid/offer market. Any order granting the 5. Applicants also request an Persons, or Second Tier Affiliates, of the requested relief would be subject to the exemption from section 22(d) of the Act Funds, solely by virtue of certain terms and conditions stated in the and rule 22c–1 under the Act as ownership interests, to effectuate application. secondary market trading in shares will purchases and redemptions in-kind. The 2. Each Fund will hold investment take place at negotiated prices, not at a deposit procedures for in-kind positions selected to correspond closely current offering price described in a purchases of Creation Units and the to the performance of an Underlying Fund’s prospectus, and not at a price redemption procedures for in-kind Index. In the case of Self-Indexing based on NAV. Applicants state that (a) redemptions of Creation Units will be Funds, an affiliated person, as defined secondary market trading in shares does the same for all purchases and in section 2(a)(3) of the Act (‘‘Affiliated not involve a Fund as a party and will redemptions, and Deposit Instruments Person’’), or an affiliated person of an not result in dilution of an investment and Redemption Instruments will be Affiliated Person (‘‘Second-Tier in shares, and (b) to the extent different valued in the same manner as those Affiliate’’), of the Trust or a Fund, of the prices exist during a given trading day, investment positions currently held by Adviser, of any sub-adviser to or or from day to day, such variances occur the Funds. Applicants also seek relief promoter of a Fund, or of the distributor as a result of third-party market forces, from the prohibitions on affiliated will compile, create, sponsor or such as supply and demand. Therefore, transactions in section 17(a) to permit a maintain the Underlying Index.2 applicants assert that secondary market Fund to sell its shares to and redeem its transactions in shares will not lead to shares from a Fund of Funds, and to 1 Applicants request that the order apply to the discrimination or preferential treatment engage in the accompanying in-kind 3 Initial Fund and any additional series of the Trust, among purchasers. Finally, applicants transactions with the Fund of Funds. and any other existing or future open-end The purchase of Creation Units by a management investment company or existing or represent that share market prices will be disciplined by arbitrage Fund of Funds directly from a Fund will future series thereof (each, included in the term be accomplished in accordance with the ‘‘Fund’’), each of which will operate as an ETF and opportunities, which should prevent will track a specified index comprised of domestic shares from trading at a material policies of the Fund of Funds and will and/or foreign equity securities and/or domestic be based on the NAVs of the Funds. and/or foreign fixed income securities (each, an discount or premium from NAV. 6. With respect to Funds that effect 9. Section 6(c) of the Act permits the ‘‘Underlying Index’’). Any Fund will (a) be advised Commission to exempt any persons or by the Initial Adviser or an entity controlling, creations and redemptions of Creation controlled by, or under common control with the Units in kind and that are based on transactions from any provision of the Initial Adviser (each of the foregoing and any certain Underlying Indexes that include successor thereto, an ‘‘Adviser’’) and (b) comply 3 The requested relief would apply to direct sales with the terms and conditions of the application. foreign securities, applicants request of shares in Creation Units by a Fund to a Fund of For purposes of the requested order, a ‘‘successor’’ relief from the requirement imposed by Funds and redemptions of those shares. Applicants, is limited to an entity or entities that result from section 22(e) in order to allow such moreover, are not seeking relief from section 17(a) a reorganization into another jurisdiction or a Funds to pay redemption proceeds for, and the requested relief will not apply to, change in the type of business organization. transactions where a Fund could be deemed an 2 Each Self-Indexing Fund will post on its website within fifteen calendar days following Affiliated Person, or a Second-Tier Affiliate, of a the identities and quantities of the investment Fund of Funds because an Adviser or an entity positions that will form the basis for the Fund’s Funds to maintain full portfolio transparency will controlling, controlled by or under common control calculation of its NAV at the end of the day. help address, together with other protections, with an Adviser provides investment advisory Applicants believe that requiring Self-Indexing conflicts of interest with respect to such Funds. services to that Fund of Funds.

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Act if such exemption is necessary or I. Self-Regulatory Organization’s Orders, MPL Orders, Non-Displayed appropriate in the public interest and Statement of the Terms of Substance of Primary Pegged Orders, and consistent with the protection of the Proposed Rule Change Discretionary Pegged Orders with an investors and the purposes fairly The Exchange proposes to amend MTS Modifier will trade against contra- intended by the policy and provisions of Rule 7.31E relating to the Minimum side orders in the Exchange Book that in the Act. Section 12(d)(1)(J) of the Act Trade Size Modifier. The proposed rule the aggregate or individually, meet the MTS.9 Once resting, MPL Orders, provides that the Commission may change is available on the Exchange’s Tracking Orders, Non-Displayed exempt any person, security, or website at www.nyse.com, at the Primary Pegged Orders, and transaction, or any class or classes of principal office of the Exchange, and at Discretionary Pegged Orders with an persons, securities, or transactions, from the Commission’s Public Reference MTS Modifier function similarly: If a any provision of section 12(d)(1) if the Room. exemption is consistent with the public contra-side order does not meet the interest and the protection of investors. II. Self-Regulatory Organization’s MTS, the incoming order will not trade Section 17(b) of the Act authorizes the Statement of the Purpose of, and with and may trade through the resting Commission to grant an order Statutory Basis for, the Proposed Rule order with the MTS Modifier. In permitting a transaction otherwise Change addition, MPL Orders, Tracking Orders, Non-Displayed Primary Pegged Orders, prohibited by section 17(a) if it finds In its filing with the Commission, the and Discretionary Pegged Orders with that (a) the terms of the proposed self-regulatory organization included an MTS Modifier will be cancelled if transaction are fair and reasonable and statements concerning the purpose of, such orders are traded in part or do not involve overreaching on the part and basis for, the proposed rule change reduced in size and the remaining of any person concerned; (b) the and discussed any comments it received proposed transaction is consistent with quantity is less than the MTS. on the proposed rule change. The text First, the Exchange proposes to the policies of each registered of those statements may be examined at investment company involved; and (c) amend its rules to make MTS Modifier the places specified in Item IV below. functionality available for an additional the proposed transaction is consistent The Exchange has prepared summaries, with the general purposes of the Act. non-displayed order that does not route, set forth in sections A, B, and C below, i.e., Non-Displayed Limit Orders.10 This For the Commission, by the Division of of the most significant parts of such proposed change is based on the rules Investment Management, under delegated statements. authority. of both the Nasdaq Stock Market LLC (‘‘Nasdaq’’) and Investors Exchange LLC Eduardo A. Aleman, A. Self-Regulatory Organization’s Statement of the Purpose of, and the (‘‘IEX’’), which both offer minimum Deputy Secretary. Statutory Basis for, the Proposed Rule trade size functionality for orders that [FR Doc. 2019–03312 Filed 2–25–19; 8:45 am] Change are not displayed and that do not BILLING CODE 8011–01–P route.11 1. Purpose Second, the Exchange proposes to The Exchange proposes to amend allow ETP Holder to elect that Limit IOC SECURITIES AND EXCHANGE Rule 7.31E relating to the Minimum Orders with an MTS Modifier trade on COMMISSION Trade Size (‘‘MTS’’) Modifier. arrival against contra-side orders in the The MTS Modifier is currently Exchange Book that individually meet [Release No. 34–85168; File No. SR– available for Limit IOC Orders,4 such order’s MTS. Rule 7.31E(i)(3)(B) NYSEAMER–2019–01] Midpoint-Liquidity (‘‘MPL’’) Orders,5 requires an ETP Holder to specify Tracking Orders,6 Non-Displayed whether an order with an MTS Modifier Self-Regulatory Organizations; NYSE Primary Pegged Orders,7 and would trade on arrival against contra- American LLC; Notice of Filing and Discretionary Pegged Orders.8 As such, side orders in the Exchange Book that in Immediate Effectiveness of Proposed the MTS Modifier is currently available the aggregate or individually meet such Rule Change To Amend Rule 7.31E only for orders that are not displayed order’s MTS. Currently, an ETP Holder Relating to the Minimum Trade Size and do not route. On arrival, Limit IOC cannot elect that a Limit IOC Order with Modifier an MTS Modifier trade only with February 20, 2019. 4 See Rule 7.31E(b)(2)(A). In sum, a Limit Order designated IOC is to be traded in whole or in part 9 Tracking Orders, including Tracking Orders Pursuant to Section 19(b)(1) 1 of the on the Exchange as soon as such order is received, with an MTS Modifier, are passive orders that do Securities Exchange Act of 1934 (the and the quantity not so traded is cancelled. Id. not trade on arrival. 5 ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 See Rule 7.31E(d)(3). In sum, an MPL Order is 10 See Rule 7.31E(d)(2). In sum, a Non-Displayed a ‘‘Limit Order that is not displayed and does not Limit Order is a Limit Order that is not displayed notice is hereby given that on February route, with a working price at the midpoint of the and does not route. Id. The Exchange understands 11, 2019, NYSE American LLC (the PBBO.’’ Id. that its affiliated exchanges, the New York Stock ‘‘Exchange’’ or ‘‘NYSE American’’) filed 6 See Rule 7.31E(d)(4). In sum, a Tracking Order Exchange, Inc. (‘‘NYSE’’), NYSE National, Inc. with the Securities and Exchange is an order to buy (sell) with a limit price that is (‘‘NYSE National’’), and NYSE Arca, Inc. (‘‘NYSE not displayed, does not route, must be entered in Arca’’, together with the Exchange, NYSE National Commission (the ‘‘Commission’’) the round lots and designated Day, and will trade only and NYSE, the ‘‘Affiliate SROs’’) have either filed proposed rule change as described in with an order to sell (buy) that is eligible to route. or intend to file similar proposes rule changes with Items I and II below, which Items have 7 See Rule 7.31E(h)(2). In sum, a Non-Displayed the Commission to extend the availability of their been prepared by the self-regulatory Pegged Order is a Pegged Order to buy (sell) with respective MTS Modifiers to Non-Displayed Limit a working price that is pegged to the PBB (PBO), Orders. See SR–NYSE–2019–01 (filed for immediate organization. The Commission is with no offset allowed. All Pegged Orders are not effectiveness on January 28, 2019) and SR– publishing this notice to solicit displayed and do not route. See Rule 7.31E(h). NYSEArca–2019–03 (filed for immediate comments on the proposed rule change 8 See Rule 7.31E(h)(3). In sum, a Discretionary effectiveness on January 28, 2019). from interested persons. Pegged Order is a Pegged Order to buy (sell) that 11 See Nasdaq Rule 4703(e) (Nasdaq’s ‘‘Minimum upon entry to the Exchange is assigned a working Quantity Order’’ may not be displayed and will be price equal to the lower (higher) of the midpoint of rejected if it includes an instruction to route) and 1 15 U.S.C. 78s(b)(1). the PBBO (‘‘Midpoint Price’’) or the limit price of IEX Rule 11.190(b)(11)(A) (IEX’s ‘‘Minimum 2 15 U.S.C. 78a. the order. All Pegged Orders are not displayed and Quantity Order’’ or ‘‘MQTY’’ is a non-displayed, 3 17 CFR 240.19b–4. do not route. See Rule 7.31E(h). non-routable order’’).

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individual order(s) in the Exchange permitted Limit IOC Orders with an prior to 30 days from the date on which Book that each meets such order’s MTS. MTS Modifier to trade against it was filed, or such shorter time as the The Exchange proposes to remove this individual orders that each meet such Commission may designate, if restriction from Rule 7.31E(i)(3)(B)(ii). order’s MTS. The Exchange has since consistent with the protection of * * * * * made the necessary technology changes investors and the public interest, the Because of the technology changes and, therefore, proposes to remove this proposed rule change has become associated with this proposed rule restriction from Rule 7.31E(i)(3)(B)(ii) as effective pursuant to Section 19(b)(3)(A) change, the Exchange will announce the it is no longer necessary. Furthermore, of the Act and Rule 19b–4(f)(6)(iii) implementation date of this proposed the Exchange’s affiliates, NYSE and thereunder.18 rule change by Trader Update. The NYSE Arca recently filed proposed rule At any time within 60 days of the Exchange anticipates that the changes with the Commission to modify filing of such proposed rule change, the implementation date will be in the their respective MTS Modifiers to align Commission summarily may second quarter of 2019. with that of NYSE American and allow temporarily suspend such rule change if orders with an MTS Modifier to execute it appears to the Commission that such 2. Statutory Basis against individual orders that each meet action is necessary or appropriate in the The proposed rule change is the incoming order’s MTS and the public interest, for the protection of consistent with Section 6(b) of the NYSE and NYSE Arca proposals did not investors, or otherwise in furtherance of Securities Exchange Act of 1934 (the include a similar restriction on Limit the purposes of the Act. If the ‘‘Act’’),12 in general, and furthers the IOC Orders.15 The Exchange notes that Commission takes such action, the objectives of Section 6(b)(5),13 in similar minimum trade size Commission shall institute proceedings particular, because it is designed to functionality on Nasdaq and IEX does under Section 19(b)(2)(B) 19 of the Act to prevent fraudulent and manipulative not prohibit Limit IOC Orders with an determine whether the proposed rule acts and practices, to promote just and MTS Modifier from being able to change should be approved or equitable principles of trade, to foster execute only against individual orders disapproved. cooperation and coordination with that meet the order’s MTS. IV. Solicitation of Comments persons engaged in facilitating transactions in securities, to remove B. Self-Regulatory Organization’s Interested persons are invited to impediments to, and perfect the Statement on Burden on Competition submit written data, views, and mechanism of, a free and open market The Exchange does not believe that arguments concerning the foregoing, and a national market system and, in the proposed rule change will impose including whether the proposed rule general, to protect investors and the any burden on competition that is not change is consistent with the Act. public interest. necessary or appropriate in furtherance Comments may be submitted by any of The Exchange believes that the of the purposes of the Act. The the following methods: proposal to expand the availability of Exchange believes that the proposed Electronic Comments the Exchange’s existing MTS Modifier to rule change is designed to increase • Use the Commission’s internet an additional non-displayed, non- competition by making available on the routable order, e.g., Non-Displayed comment form (http://www.sec.gov/ Exchange functionality that is already rules/sro.shtml); or Limit Orders, would remove available on Nasdaq and IEX. The • impediments to, and perfect the Send an email to rule-comments@ Exchange also believes that the sec.gov. Please include File Number SR– mechanism of, a free and open market proposed rule change would promote and a national market system and, in NYSEAMER–2019–01 on the subject competition by providing market line. general, to protect investors and the participants with an additional venue to public interest, because the proposed which to route non-displayed, non- Paper Comments rule change is based on similar routable orders with an MTS Modifier. • Send paper comments in triplicate minimum trade size functionality on to Secretary, Securities and Exchange Nasdaq and IEX, which both similarly C. Self-Regulatory Organization’s Statement on Comments on the Commission, 100 F Street NE, make minimum trade size functionality Washington, DC 20549–1090. available to non-displayed, non-routable Proposed Rule Change Received From All submissions should refer to File orders.14 Members, Participants, or Others Number SR–NYSEAMER–2019–01. This The Exchange also believes that the No written comments were solicited file number should be included on the proposal to allow ETP Holder to elect or received with respect to the proposed subject line if email is used. To help the that Limit IOC Orders with an MTS rule change. Commission process and review your Modifier trade on arrival against contra- comments more efficiently, please use side orders in the Exchange Book that III. Date of Effectiveness of the only one method. The Commission will individually meet such order’s MTS Proposed Rule Change and Timing for post all comments on the Commission’s would remove impediments to, and Commission Action internet website (http://www.sec.gov/ perfect the mechanism of, a free and The Exchange has filed the proposed rules/sro.shtml). Copies of the open market and a national market rule change pursuant to Section submission, all subsequent system and, in general, to protect 19(b)(3)(A)(iii) of the Act 16 and Rule amendments, all written statements investors and the public interest, 19b–4(f)(6) thereunder.17 Because the because the proposed rule change proposed rule change does not: (i) 18 17 CFR 240.19b–4(f)(6). In addition, Rule 19b- would provide ETP Holders greater Significantly affect the protection of 4(f)(6)(iii) requires a self-regulatory organization to control over the execution of their Limit investors or the public interest; (ii) give the Commission written notice of its intent to IOC Orders. The Exchange did not impose any significant burden on file the proposed rule change, along with a brief previously support functionality that competition; and (iii) become operative description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time 12 15 U.S.C. 78f(b). 15 See supra note 10. as designated by the Commission. The Exchange 13 15 U.S.C. 78f(b)(5). 16 15 U.S.C. 78s(b)(3)(A)(iii). has satisfied this requirement. 14 See supra note 11. 17 17 CFR 240.19b–4(f)(6). 19 15 U.S.C. 78s(b)(2)(B).

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with respect to the proposed rule FOR FURTHER INFORMATION CONTACT: DATES: Submit comments on or before change that are filed with the Joseph Eitel, Director, Office of April 29, 2019. Commission, and all written Personnel Security, joseph.eitel@ ADDRESSES: Send all comments to communications relating to the sba.gov, 303–844–7750, or Curtis B. Jermanne Perry, Management Analyst, proposed rule change between the Rich, Management Analyst, 202–205– Office of Surety Guarantee, Small Commission and any person, other than 7030, [email protected]. Business Administration, 409 3rd Street, those that may be withheld from the SUPPLEMENTARY INFORMATION: Small 6th Floor, Washington, DC 20416. public in accordance with the Business Administration SBA Form 912 FOR FURTHER INFORMATION CONTACT: provisions of 5 U.S.C. 552, will be is used to collect information needed to Jermanne Perry, Management Analyst, available for website viewing and make character determinations with Office of Surety Guarantee, printing in the Commission’s Public respect to applicants for monetary loan [email protected] 202–401–8275, Reference Room, 100 F Street NE, assistance or applicants for participation or Curtis B. Rich, Management Analyst, Washington, DC 20549 on official in SBA programs. The information 202–205–7030, [email protected]. business days between the hours of collected is used as the basis for SUPPLEMENTARY INFORMATION: Small 10:00 a.m. and 3:00 p.m. Copies of the conducting name checks at national filing also will be available for Business Administration (SBA) Surety Federal Bureau of Investigation (FBI) Bond Guarantee Program was created to inspection and copying at the principal and local levels. office of the Exchange. All comments encourage surety companies to provide received will be posted without change. Solicitation of Public Comments bonding for small contractors. The Persons submitting comments are information collected on this form from SBA is requesting comments on (a) small businesses and surety companies cautioned that we do not redact or edit Whether the collection of information is personal identifying information from will be used to evaluate the eligibility of necessary for the agency to properly applicants for contracts up to $250,000. comment submissions. You should perform its functions; (b) whether the submit only information that you wish burden estimates are accurate; (c) Solicitation of Public Comments to make available publicly. All whether there are ways to minimize the SBA is requesting comments on (a) submissions should refer to File burden, including through the use of Whether the collection of information is Number SR–NYSEAMER–2019–01 and automated techniques or other forms of necessary for the agency to properly should be submitted on or before March information technology; and (d) whether perform its functions; (b) whether the 19, 2019. there are ways to enhance the quality, burden estimates are accurate; (c) For the Commission, by the Division of utility, and clarity of the information. whether there are ways to minimize the Trading and Markets, pursuant to delegated burden, including through the use of 20 Summary of Information Collection authority. automated techniques or other forms of Eduardo A. Aleman, Title: Statement of Personal History. information technology; and (d) whether Deputy Secretary. Description of Respondents: there are ways to enhance the quality, [FR Doc. 2019–03218 Filed 2–25–19; 8:45 am] Applicants participating in SBA utility, and clarity of the information. BILLING CODE 8011–01–P programs. Form Number: SBA Form 912. Summary of Information Collection Total Estimated Annual Responses: Title: Quick Bond Guarantee SMALL BUSINESS ADMINISTRATION 142,000. Application and Agreement. Total Estimated Annual Hour Burden: Description of Respondents: Surety Data Collection Available for Public 35,500. Companies. Comments Curtis Rich, Form Number: SBA Form 990A. Management Analyst. Total Estimated Annual Responses: ACTION: 60-Day notice and request for 21,046. comments. [FR Doc. 2019–03230 Filed 2–25–19; 8:45 am] Total Estimated Annual Hour Burden: BILLING CODE 8025–01–P 3,065. SUMMARY: The Small Business Administration (SBA) intends to request Curtis Rich, approval, from the Office of SMALL BUSINESS ADMINISTRATION Management Analyst. Management and Budget (OMB) for the Data Collection Available for Public [FR Doc. 2019–03229 Filed 2–25–19; 8:45 am] collection of information described BILLING CODE 8025–01–P below. The Paperwork Reduction Act Comments (PRA) requires federal agencies to ACTION: 60-Day notice and request for publish a notice in the Federal Register SOCIAL SECURITY ADMINISTRATION concerning each proposed collection of comments. information before submission to OMB, SUMMARY: The Small Business [Docket No. SSA–2019–0005] and to allow 60 days for public Administration (SBA) intends to request Agreement on Social Security Between comment in response to the notice. This approval, from the Office of notice complies with that requirement. the United States and Iceland; Entry Management and Budget (OMB) for the Into Force DATES: Submit comments on or before collection of information described April 29, 2019. below. The Paperwork Reduction Act AGENCY: Social Security Administration. ADDRESSES: Send all comments to (PRA) requires federal agencies to ACTION: Notice. Joseph Eitel, Director, Office of publish a notice in the Federal Register Personnel Security, Small Business concerning each proposed collection of SUMMARY: We are giving notice that an Administration, 721 19th Street, Room information before submission to OMB, agreement coordinating the United 392, Denver, CO 80202. and to allow 60 days for public States (U.S.) and Icelandic social comment in response to the notice. This security programs will go into force 20 17 CFR 200.30–3(a)(12). notice complies with that requirement. effective on March 1, 2019. The

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Agreement with Iceland, which was DEPARTMENT OF STATE • Average Time per Response: 15 signed on September 27, 2016, is similar minutes. [Public Notice: 10673] to U.S. social security agreements • Total Estimated Burden Time: 600 already in force with 29 other hours. 30-Day Notice of Proposed Information • countries—Australia, Austria, Belgium, Collection: Local U.S. Citizen Skills/ Frequency: On occasion. • Obligation to Respond: Voluntary. Brazil, Canada, Chile, the Czech Resources Survey Republic, Denmark, Finland, France, We are soliciting public comments to Germany, Greece, Hungary, Ireland, ACTION: Notice of request for public permit the Department to: • Evaluate whether the proposed Italy, Japan, Korea (South), Luxembourg, comment and submission to OMB of information collection is necessary for the Netherlands, Norway, Poland, proposed collection of information. the proper functions of the Department. Portugal, the Slovak Republic, Slovenia, • Spain, Sweden, Switzerland, the United SUMMARY: The Department of State has Evaluate the accuracy of our Kingdom, and Uruguay. Section 233 of submitted the information collection estimate of the time and cost burden for the Social Security Act authorizes described below to the Office of this proposed collection, including the agreements of this type. Management and Budget (OMB) for validity of the methodology and approval. In accordance with the assumptions used. • SUPPLEMENTARY INFORMATION: Like the Paperwork Reduction Act of 1995 we Enhance the quality, utility, and other agreements, the U.S.-Icelandic are requesting comments on this clarity of the information to be Agreement eliminates dual social collected. collection from all interested • security coverage. This situation exists individuals and organizations. The Minimize the reporting burden on when a worker from one country works purpose of this Notice is to allow 30 those who are to respond, including the in the other country and has coverage days for public comment. use of automated collection techniques under the social security systems of or other forms of information DATES: Submit comments directly to the both countries for the same work. technology. Office of Management and Budget Without such agreements in force, when Please note that comments submitted (OMB) up to March 28, 2019. dual coverage occurs, the worker, the in response to this Notice are public worker’s employer, or both may be ADDRESSES: Direct comments to the record. Before including any detailed required to pay social security Department of State Desk Officer in the personal information, you should be contributions to the two countries Office of Information and Regulatory aware that your comments as submitted, simultaneously. Under the U.S.- Affairs at the Office of Management and including your personal information, Icelandic Agreement, a worker who is Budget (OMB). You may submit will be available for public review. comments by the following methods: sent by an employer in one country to • _ Abstract of Proposed Collection work in the other country for 5 or fewer Email: oira submission@ years remains covered only by the omb.eop.gov. You must include the DS The Local U.S. Citizen Skills/ sending country. The Agreement form number, information collection Resources Survey is a systematic includes additional rules that eliminate title, and the OMB control number in method of gathering information about the subject line of your message. skills and resources from U.S. citizens dual U.S. and Icelandic coverage in • other work situations. Fax: 202–395–5806. Attention: Desk that will assist in improving the well- Officer for Department of State. being of other U.S. citizens affected or The Agreement also helps eliminate FOR FURTHER INFORMATION CONTACT: potentially affected by a crisis. situations where workers suffer a loss of Direct requests for additional Methodology benefit rights because they have divided information regarding the collection their careers between the two countries. listed in this notice, including requests This information collection can be Under the Agreement, workers may for copies of the proposed collection completed by the respondent qualify for partial U.S. benefits or partial instrument and supporting documents, electronically or manually. The Icelandic benefits based on combined to Derek A. Rivers, Bureau of Consular information will be collected on-site at (totalized) work credits from both Affairs, Overseas Citizens Services (CA/ a U.S. Embassy/Consulate, by mail, fax, countries. OCS/PMO), U.S. Department of State, or email. Persons who wish to receive copies of 2201 C St. NW, Washington, DC 20522, Michelle Bernier-Toth, the Agreement or who want more who may be reached at RiversDA@ Managing Director, Bureau of Consular information about its provisions may state.gov and 202–485–6332. Affairs, Department of State. write to the Social Security SUPPLEMENTARY INFORMATION: [FR Doc. 2019–03274 Filed 2–25–19; 8:45 am] Administration, Office of Data • Title of Information Collection: BILLING CODE 4710–06–P Exchange, Policy Publications, and Local U.S. Citizen Skills/Resources International Negotiations, 4700 Annex Survey. Building, 6401 Security Boulevard, • OMB Control Number: OMB No. DEPARTMENT OF STATE Baltimore, MD 21235, or visit the Social 1405–0188. Security website at • Type of Request: Revision of a [Public Notice: 10672] www.socialsecurity.gov/international. Currently Approved Collection. The full text of the Agreement and its • 30-Day Notice of Proposed Information Originating Office: Bureau of Collection: Request for Entry Into accompanying Administrative Consular Affairs, Overseas Citizens Arrangement are available at https:// Children’s Passport Issuance Alert Services (CA/OCS). Program www.ssa.gov/international/Agreement_ • Form Number: DS–5506. • Texts/iceland.html. Respondents: United States ACTION: Notice of request for public Citizens. comment and submission to OMB of Nancy A. Berryhill, • Estimated Number of Respondents: proposed collection of information. Acting Commissioner of Social Security. 2,400. [FR Doc. 2019–03271 Filed 2–25–19; 8:45 am] • Estimated Number of Responses: SUMMARY: The Department of State has BILLING CODE 4191–02–P 2,400. submitted the information collection

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described below to the Office of this proposed collection, including the DEPARTMENT OF TRANSPORTATION Management and Budget (OMB) for validity of the methodology and approval. In accordance with the assumptions used. Federal Aviation Administration Paperwork Reduction Act of 1995 we • Enhance the quality, utility, and Agency Information Collection are requesting comments on this clarity of the information to be collection from all interested Activities: Requests for Comments; collected. Clearance of Renewed Approval of individuals and organizations. The • purpose of this Notice is to allow 30 Minimize the reporting burden on Information Collection: Air Carrier days for public comment. those who are to respond, including the Contract Maintenance Requirements use of automated collection techniques DATES: Submit comments directly to the AGENCY: or other forms of information Federal Aviation Office of Management and Budget technology. Administration (FAA), DOT. (OMB) up to March 28, 2019. ACTION: Notice and request for ADDRESSES: Direct comments to the Please note that comments submitted comments. Department of State Desk Officer in the in response to this Notice are public Office of Information and Regulatory record. Before including any detailed SUMMARY: In accordance with the Affairs at the Office of Management and personal information, you should be Paperwork Reduction Act of 1995, FAA Budget (OMB). You may submit aware that your comments as submitted, invites public comments about our comments by the following methods: including your personal information, intention to request the Office of • Email: oira_submission@ will be available for public review. Management and Budget (OMB) approval to renew an information omb.eop.gov. You must include the DS Abstract of Proposed Collection form number, information collection collection. The Federal Register Notice title, and the OMB control number in The information requested will be with a 60-day comment period soliciting the subject line of your message. used to support entry of the name of a comments on the following collection of • Fax: 202–395–5806. Attention: Desk minor (an unmarried, unemancipated information was published on December Officer for Department of State. person under 18 years of age) into the 20, 2018. The information to be collected is necessary because the FAA FOR FURTHER INFORMATION CONTACT: Children’s Passport Issuance Alert Direct requests for additional Program (CPIAP). CPIAP provides a needs accurate and up to date data information regarding the collection mechanism for parents or other persons indicating who is performing listed in this notice, including requests with legal custody of a minor to obtain maintenance on behalf of air carriers, for copies of the proposed collection information regarding whether the what type of maintenance is being instrument and supporting documents, Department has received a passport performed, and where the maintenance to Derek A. Rivers, Bureau of Consular application for the minor. This program is being performed. This collected Affairs, Overseas Citizens Services (CA/ was developed as a means to prevent information will be used by the FAA to OCS/PMO), U.S. Department of State, international parental child abduction adequately target its inspection 2201 C. St. NW, Washington, DC 20522, and to help prevent other travel of a resources for surveillance and make who may be reached at mailto: minor without the consent of a parent accurate risk assessments. [email protected] and 202–485–6332. or legal guardian. If a minor’s name and DATES: Written comments should be submitted by March 28, 2019. SUPPLEMENTARY INFORMATION: other identifying information has been • Title of Information Collection: entered into the CPIAP, when the ADDRESSES: Interested persons are Request for Entry into Children’s Department receives an application for invited to submit written comments on Passport Issuance Alert Program. a new, replacement, or renewed the proposed information collection to • OMB Control Number: 1405–0169. passport for the minor, the application the Office of Information and Regulatory • Type of Request: Revision of a may be placed on hold for up to 90 days Affairs, Office of Management and previously approved information and the Office of Children’s Issues may Budget. Comments should be addressed collection. attempt to notify the requestor of receipt to the attention of the Desk Officer, • Originating Office: Bureau of of the application. Form DS–3077 will Department of Transportation/FAA, and _ Consular Affairs, Overseas Citizens be primarily submitted by a parent or sent via electronic mail to oira Services (CA/OCS). legal guardian of a minor. This [email protected], or faxed to • Form Number: DS–3077. collection is authorized by 22 CFR (202) 395–6974, or mailed to the Office • Respondents: Concerned parents or 51.28, which is the regulation that of Information and Regulatory Affairs, their agents, institutions, or courts. implements the statutory two-parent Office of Management and Budget, • Estimated Number of Respondents: consent requirement and prescribes the Docket Library, Room 10102, 725 17th 4,000. bases for an exception to the Street NW, Washington, DC 20503. • Estimated Number of Responses: requirement. Public Comments Invited: You are asked to comment on any aspect of this 4,000. Methodology • Average Time per Response: 30 information collection, including (a) minutes. The completed Form DS–3077 can be Whether the proposed collection of • Total Estimated Burden Time: 2,000 filled out online and printed or information is necessary for FAA’s hours. completed by hand. The form must be performance; (b) the accuracy of the • Frequency: On Occasion. manually signed and submitted to the estimated burden; (c) ways for FAA to • Obligation to Respond: Voluntary. Office of Children’s Issues by email, fax enhance the quality, utility and clarity We are soliciting public comments to or mail with supporting documentation. of the information collection; and (d) permit the Department to: ways that the burden could be • Evaluate whether the proposed Michelle Bernier-Toth, minimized without reducing the quality information collection is necessary for Managing Director, Bureau of Consular of the collected information. The agency the proper functions of the Department. Affairs, Department of State. will summarize and/or include your • Evaluate the accuracy of our [FR Doc. 2019–03272 Filed 2–25–19; 8:45 am] comments in the request for OMB’s estimate of the time and cost burden for BILLING CODE 4710–06–P clearance of this information collection.

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FOR FURTHER INFORMATION CONTACT: Estimated Total Annual Burden: State of California: The Westbound State Barbara Hall at (940) 594–5913, or by 22,464 hours. Route 91 Improvement Project will email at: [email protected]. widen and improve approximately 4 Barbara Hall, miles (mi) of freeway along westbound SUPPLEMENTARY INFORMATION: FAA Information Collection Clearance State Route 91 (SR–91) between OMB Control Number: 2120–0766. Officer, IT Enterprises Business Services Division, ASP–110. approximately Shoemaker Avenue and Title: Air Carrier Contract the Interstate 605 (I–605) interchange, [FR Doc. 2019–03228 Filed 2–25–19; 8:45 am] Maintenance Requirements. and at the I–605 northbound exit to BILLING CODE 4910–13–P Form Numbers: There are no forms Alondra Boulevard. Caltrans approved associated with this collection. the construction of the Build Alternative DEPARTMENT OF TRANSPORTATION with Design Option 1 (Reduced Lane/ Type of Review: This is a renewal of Shoulder Width) and Design Option 3 an information collection. Federal Highway Administration (Pioneer Boulevard Westbound Ramps/ Background: The Federal Register 168th Alignment). Also, as part of the Notice with a 60-day comment period Notice of Final Federal Agency Actions project, the Gridley Road Overcrossing soliciting comments on the following on Proposed Highway in California will be improved to a two-lane road collection of information was published with standard shoulders and sidewalks on December 20, 2018 (83 FR 65391). AGENCY: Federal Highway on both sides. The actions by the Air carrier maintenance has evolved Administration (FHWA), DOT. Federal agencies, and the laws under from mostly an ‘‘in-house’’ operation to ACTION: Notice of Limitation on Claims which such actions were taken, are an extended network of maintenance for Judicial Review of Actions by the described in the Environmental providers that fulfill contracts with air California Department of Transportation Assessment/Finding of No Significant carriers to perform their aircraft (Caltrans), pursuant to 23 U.S.C. 327. Impact (EA/FONSI) for the project, maintenance. Any person performing approved on January 17, 2019, and in maintenance for an air carrier must SUMMARY: The FHWA, on behalf of other documents in Caltrans project follow the air carrier’s maintenance Caltrans, is issuing this notice to records. The EA/FONSI and other manual. announce actions taken by Caltrans that project records are available by The FAA has found that, although an are final. The actions relate to a contacting Caltrans at the addresses air carrier is required to list its proposed highway project on State provided above. The Caltrans EA/FONSI maintenance providers and a general Route 91 (Post Miles 16.9–19.8) and on can be viewed and downloaded from description of the work to be done in its Interstate 605 (Post Miles 5.0–5.8) in the the project website at http:// maintenance manual, these lists are not Cities of Cerritos and Artesia, in the www.dot.ca.gov/d7/env-docs/. County of Los Angeles, State of always kept up to date, are not always This notice applies to all Federal California. Those actions grant licenses, complete, and are not always in a format agency decisions as of the issuance date permits, and approvals for the project. that is readily useful for FAA oversight of this notice and all laws under which and analysis purposes. Without accurate DATES: By this notice, the FHWA, on such actions were taken, including but and complete information on the work behalf of Caltrans, is advising the public not limited to: being performed for air carriers, the of final agency actions subject to 23 FAA cannot adequately target its U.S.C. 139(l)(1). A claim seeking 1. General: National Environmental inspection resources for surveillance judicial review of the Federal agency Policy Act (NEPA) (42 U.S.C. 4321– and make accurate risk assessments. actions on the highway project will be 4351) 2. Clean Air Act (42 U.S.C. 7401– This collection of information barred unless the claim is filed on or 7671(q)) supports regulatory requirements before July 26, 2019. If the Federal law necessary under 14 CFR part 121 and that authorizes judicial review of a 3. Migratory Bird Treaty Act (16 U.S.C. part 135 to ensure safety of flight by claim provides a time period of less 703–712) than 150 days for filing such claim, then requiring air carriers to provide a list to 4. Historic and Cultural Resources: that shorter time period still applies. the FAA of all persons with whom they Section 106 of the National Historic contract their maintenance. The list FOR FURTHER INFORMATION CONTACT: For Preservation Act of 1966, as must be updated with any changes, Caltrans: Jinous Saleh, Senior amended (16 U.S.C. 470(f) et seq.) Environmental Planner, Caltrans District including additions or deletions, and 5. Clean Water Act (Section 401) (33 7, 100 South Main Street, Suite MS 16A, the updated list provided to the FAA in U.S.C. 1251–1377) a format acceptable to the FAA by the Los Angeles, California, 90012, (213) last day of each calendar month. 897–0683, [email protected]. For 6. Federal Endangered Species Act of 1973 (16 U.S.C. 1531–1543) This collection also supports the FHWA, Larry Vinzant at (916) 498–5040 7. Executive Order 11990—Protection of FAA’s strategic goal to provide to the or email [email protected]. Wetlands next level of safety, by achieving the SUPPLEMENTARY INFORMATION: Effective lowest possible accident rate and always July 1, 2007, the Federal Highway 8. Department of Transportation Act of improving safety, so all users of our Administration (FHWA) assigned, and 1966, Section 4(f) (49 U.S.C. 303) aviation system can arrive safely at their the California Department of 9. Executive Order 13112—Invasive destinations. Transportation (Caltrans) assumed, Species Respondents: 312 air carriers (110 environmental responsibilities for this project pursuant to 23 U.S.C. 327. (Catalog of Federal Domestic Assistance large air carriers and 202 small air Program Number 20.205, Highway Planning carriers). Notice is hereby given that the Caltrans and Construction. The regulations and the FHWA have taken final agency Frequency: Monthly. implementing Executive Order 12372 actions subject to U.S.C. 139(l)(1) by regarding intergovernmental consultation on Estimated Average Burden per issuing licenses, permits, and approvals Federal programs and activities apply to this Response: 6 hours. for the following highway project in the program.)

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Authority: 23 U.S.C. 139(l)(1). scheduling a public hearing in document provides the public notice Tashia J. Clemons, connection with these proceedings since that by a document dated January 25, the facts do not appear to warrant a 2019, the Logansport and Eel River Director, Planning and Environment, Federal hearing. If any interested parties desire Highway Administration, Sacramento, Railroad Short Line, Inc. (LERR) California. an opportunity for oral comment and a petitioned the Federal Railroad public hearing, they should notify FRA, Administration (FRA) for a waiver of [FR Doc. 2019–03250 Filed 2–25–19; 8:45 am] in writing, before the end of the compliance from certain provisions of BILLING CODE 4910–RY–P comment period and specify the basis the Federal railroad safety regulations for their request. contained at 49 CFR part 234. FRA All communications concerning these DEPARTMENT OF TRANSPORTATION assigned the petition Docket Number proceedings should identify the FRA–2019–0013. Federal Railroad Administration appropriate docket number and may be Specifically, LERR seeks relief from submitted by any of the following the Emergency Notification System [Docket Number FRA–2009–0078] methods: regulations in 49 CFR part 234, subpart • Website: http:// Petition for Waiver of Compliance E, Requirements for Emergency www.regulations.gov. Follow the online Notification for Telephonic Reporting of Under part 211 of Title 49 Code of instructions for submitting comments. Unsafe Condition at Highway-Rail and • Fax: 202–493–2251. Federal Regulations (CFR), this • Pathway Grade Crossings. LERR document provides the public notice Mail: Docket Operations Facility, explains that the trackage involved is that on January 31, 2019, the American U.S. Department of Transportation, 1200 currently out of service and that they are Short Line and Regional Railroad New Jersey Avenue SE, W12–140, in the process of selling the trackage to Washington, DC 20590. Association (ASLRRA) petitioned the • the Indiana Transportation Museum. Federal Railroad Administration (FRA) Hand Delivery: 1200 New Jersey Avenue SE, Room W12–140, A copy of the petition, as well as any for an amended waiver of compliance written communications concerning the from certain provisions of the Federal Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, petition, is available for review online at hours of service laws contained at 49 www.regulations.gov and in person at U.S.C. 21103(a)(4), which, in part, except Federal Holidays. Communications received by April the Department of Transportation’s require a train employee to receive 48 12, 2019 will be considered by FRA Docket Operations Facility, 1200 New hours off duty after initiating an on-duty before final action is taken. Comments Jersey Ave. SE, W12–140, Washington, period for 6 consecutive days. FRA received after that date will be DC 20590. The Docket Operations assigned the petition Docket Number considered if practicable. Facility is open from 9 a.m. to 5 p.m., FRA–2009–0078. Anyone can search the electronic Monday through Friday, except Federal Specifically, ASLRRA seeks to amend form of any written communications Holidays. its existing waiver to add seven member and comments received into any of our Interested parties are invited to railroads that did not participate in the dockets by the name of the individual participate in these proceedings by original waiver, but in the fourth quarter submitting the comment (or signing the submitting written views, data, or of 2018 determined that they now wish document, if submitted on behalf of an comments. FRA does not anticipate to participate. ASLRRA states the association, business, labor union, etc.). scheduling a public hearing in following railroads expressed a desire to Under 5 U.S.C. 553(c), DOT solicits connection with these proceedings since participate in the waiver, and maintain comments from the public to better the facts do not appear to warrant a at their headquarters supporting inform its processes. DOT posts these hearing. If any interested party desires documentation of employee support as comments, without edit, including any an opportunity for oral comment, they required: personal information the commenter should notify FRA, in writing, before • Camp Chase Railway, LLC provides, to www.regulations.gov, as the end of the comment period and • Chesapeake and Indiana Railroad described in the system of records specify the basis for their request. Company notice (DOT/ALL–14 FDMS), which can All communications concerning these • D&I Railroad be reviewed at https:// proceedings should identify the • Foster Townsend Rail Logistics www.transportation.gov/privacy. See appropriate docket number and may be (FTRL) also https://www.regulations.gov/ submitted by any of the following • San Pedro Valley Railroad privacyNotice for the privacy notice of methods: • • Vermillion Valley Railroad Co, Inc. regulations.gov. Website: http://www.regulations.gov • Youngstown & Southeastern Railroad Follow the online instructions for Issued in Washington, DC. Company, Inc. submitting comments. Robert C. Lauby, A copy of the petition, as well as any • Fax: 202–493–2251. written communications concerning the Associate Administrator for Railroad Safety • Mail: Docket Operations Facility, Chief Safety Officer. petition, is available for review online at U.S. Department of Transportation, 1200 www.regulations.gov and in person at [FR Doc. 2019–03244 Filed 2–25–19; 8:45 am] New Jersey Avenue SE, W12–140, the U.S. Department of Transportation’s BILLING CODE 4910–06–P Washington, DC 20590. (DOT) Docket Operations Facility, 1200 • Hand Delivery: 1200 New Jersey Avenue SE, Room W12–140, New Jersey Avenue SE, W12–140, DEPARTMENT OF TRANSPORTATION Washington, DC 20590. The Docket Washington, DC 20590, between 9 a.m. Operations Facility is open from 9 a.m. Federal Railroad Administration and 5 p.m., Monday through Friday, to 5 p.m., Monday through Friday, except Federal Holidays. except Federal Holidays. [Docket Number FRA–2019–0013] Communications received by April Interested parties are invited to Petition for Waiver of Compliance 12, 2019 will be considered by FRA participate in these proceedings by before final action is taken. Comments submitting written views, data, or Under part 211 of Title 49 of the Code received after that date will be comments. FRA does not anticipate of Federal Regulations (CFR), this considered as far as practicable.

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Anyone is able to search the accordance with Section 5 of the 26, 2019, to ensure transmission to electronic form of any written Combating Human Trafficking in ACHT members prior to the meeting. communications and comments Commercial Vehicles Act (Pub. L. 115– Comments received after that date and received into any of our dockets by the 99) to make recommendations to the time will be distributed to the members name of the individual submitting the Secretary of Transportation on actions but may not be reviewed prior to the comment (or signing the document, if the Department can take to help combat meeting. submitted on behalf of an association, human trafficking, and to develop Copies of the meeting minutes will be business, labor union, etc.). In recommended best practices for States available on the ACHT internet website accordance with 5 U.S.C. 553(c), DOT and State and local transportation at https://www.transportation.gov/ solicits comments from the public to stakeholders in combatting human stophumantrafficking/acht. better inform its processes. DOT posts trafficking. * * * * * these comments, without edit, including II. Agenda Dated: February 8, 2019. any personal information the Joel Szabat, commenter provides, to At the March 12, 2019, meeting, the agenda will cover the following topics: Assistant Secretary, Office for Aviation and www.regulations.gov, as described in International Affairs. the system of records notice (DOT/ALL– • Welcome [FR Doc. 2019–03280 Filed 2–25–19; 8:45 am] 14 FDMS), which can be reviewed at • Subcommittee Reports BILLING CODE 4910–9x–P www.dot.gov/privacy. See also http:// • Discussion and Deliberation www.regulations.gov/#!privacyNotice • Public Participation for the privacy notice of regulations.gov. • Next Steps and Closing DEPARTMENT OF THE TREASURY Issued in Washington, DC. A final agenda will be posted on the Robert C. Lauby, ACHT internet website at https:// Office of Foreign Assets Control Associate Administrator for Railroad Safety www.transportation.gov/stophuman Chief Safety Officer. trafficking/acht at least one week in Notice of OFAC Sanctions Actions [FR Doc. 2019–03245 Filed 2–25–19; 8:45 am] advance of the meeting. AGENCY: Office of Foreign Assets BILLING CODE 4910–06–P III. Public Participation Control, Department of the Treasury. The meeting will be open to the ACTION: Notice. DEPARTMENT OF TRANSPORTATION public on a first-come, first served basis, SUMMARY: The U.S. Department of the as space is limited. Members of the Treasury’s Office of Foreign Assets Department of Transportation Advisory public who wish to attend in-person are Control (OFAC) is publishing the names Committee on Human Trafficking; asked to register via email by submitting of persons that have been placed on Notice of Public Meeting their name and affiliation to trafficking@ OFAC’s Specially Designated Nationals dot.gov by February 26, 2019. and Blocked Persons List based on AGENCY: Office of the Secretary of Individuals requesting accessibility OFAC’s determination that one or more Transportation, Department of accommodations, such as sign language, Transportation. applicable legal criteria were satisfied. interpretation, or other ancillary aids, All property and interests in property ACTION: Notice of public meeting. may do so by submitting their request subject to U.S. jurisdiction of these via email to [email protected] by SUMMARY: This notice announces a persons are blocked, and U.S. persons February 26, 2019. meeting of the Department of are generally prohibited from engaging There will be 30 minutes allotted for Transportation Advisory Committee on in transactions with them. oral comments from members of the Human Trafficking. DATES: See SUPPLEMENTARY INFORMATION public joining the meeting. To section for effective date. DATES: The meeting will be held on accommodate as many speakers as FOR FURTHER INFORMATION CONTACT: March 12, 2019, from 10:00 a.m. to 4:30 possible, the time for each commenter p.m. EDT. OFAC: Associate Director for Global may be limited. Individuals wishing to Targeting, tel.: 202–622–2420; Assistant ADDRESSES: The meeting will be held at reserve speaking time during the Director for Licensing, tel.: 202–622– the U.S. Department of Transportation, meeting must submit a request at the 2480; Assistant Director for Regulatory 1200 New Jersey Avenue SE, time of registration, as well as the name, Affairs, tel.: 202–622–4855; Assistant Washington, DC 20590. Individuals address, and organizational affiliation of Director for Sanctions Compliance & wishing for audio participation, and any the proposed speaker. If the number of Evaluation, tel.: 202–622–2490; or the person requiring accessibility registrants requesting to make Department of the Treasury’s Office of accommodations, should contact the statements is greater than can be the General Counsel: Office of the Chief Official listed in the next section. reasonably accommodated during the Counsel (Foreign Assets Control), tel.: FOR FURTHER INFORMATION CONTACT: meeting, the Office of the Secretary may 202–622–2410. Nicole L. Bambas, Senior Advisor, conduct a lottery to determine the SUPPLEMENTARY INFORMATION: Office of International Transportation speakers. Speakers are requested to and Trade, U.S. Department of submit a written copy of their prepared Electronic Availability Transportation, at [email protected] or remarks by 5:00 p.m. EST on February The Specially Designated Nationals (202) 366–5058. Also visit the ACHT 26, 2019, for inclusion in the meeting and Blocked Persons List (SDN List) and internet website at https:// records and for circulation to ACHT additional information concerning www.transportation.gov/ members. All prepared remarks OFAC sanctions programs are available stophumantrafficking/acht. submitted on time will be accepted and on OFAC’s website (https:// SUPPLEMENTARY INFORMATION: considered as part of the record. www.treasury.gov/ofac). Persons who wish to submit written I. Background comments for consideration by ACHT Notice of OFAC Actions The Advisory Committee on Human during the meeting must submit them On February 20, 2019, OFAC Trafficking (ACHT) was created in no later than 5:00 p.m. EST on February determined that the property and

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interests in property subject to U.S. Linked To: HAKIMZADA, Harmohan). Company Number jurisdiction of the following persons are Designated pursuant to section 805(b)(2) U51900DL2012PLC230619 (India) blocked under the relevant sanctions of the Kingpin Act for materially [SDNTK] (Linked To: HAKIMZADA, authorities listed below. assisting in, or providing financial or Jasmeet; Linked To: HAKIMZADA, technological support for or to, or Harmohan). Designated pursuant to Individuals providing goods or services in support section 805(b)(3) of the Kingpin Act for 1. HAKIMZADA, Jasmeet (a.k.a. of, the international narcotics trafficking being owned, controlled, or directed by, SINGH, Jasmeet), Flat 17, 2nd FL Atlas activities of the Jasmeet HAKIMZADA, or acting for or on behalf of Jasmeet Tower, Jamal Abdud Nasir Rd., Sharjah, a significant foreign narcotics trafficker HAKIMZADA, a significant foreign United Arab Emirates; DOB 26 Jun 1979; designated by the Secretary of the narcotics trafficker designated by the nationality India; Gender Male; Passport Treasury pursuant to the Kingpin Act, Secretary of the Treasury pursuant to Z2030393 (India) (individual) [SDNTK]. and Harmohan HAKIMZADA, a foreign the Kingpin Act, and Harmohan Identified as a significant foreign person designated by the Secretary of HAKIMZADA, a foreign person narcotics trafficker pursuant to section the Treasury pursuant to the Kingpin designated by the Secretary of the 805(b)(1) of the Foreign Narcotics Act; also designated pursuant to section Treasury pursuant to the Kingpin Act. Kingpin Designation Act, 21 U.S.C. 805(b)(3) of the Kingpin Act for being Dated: February 20, 2019. 1904(b)(1) (Kingpin Act). owned, controlled, or directed by, or 2. HAKIMZADA, Harmohan Singh acting for or on behalf of, Jasmeet Andrea M. Gacki, (a.k.a. SING, Har Mohan), Flat 17, 2nd HAKIMZADA, a significant foreign Director, Office of Foreign Assets Control. FL Atlas Tower, Jamal Abdud Nasir Rd., narcotics trafficker designated by the [FR Doc. 2019–03314 Filed 2–25–19; 8:45 am] Sharjah, United Arab Emirates; DOB 23 Secretary of the Treasury pursuant to BILLING CODE 4810–AL–P Jun 1953; nationality India; Gender the Foreign Narcotics Kingpin Male; Passport 1850327 (India); alt. Designation Act, and Harmohan Passport Z1432933 (India) (individual) HAKIMZADA, a foreign person DEPARTMENT OF THE TREASURY [SDNTK] (Linked To: HAKIMZADA, designated by the Secretary of the Internal Revenue Service Jasmeet) Designated pursuant to section Treasury pursuant to the Foreign 805(b)(2) of the Kingpin Act, for Narcotics Kingpin Designation Act. materially assisting in, or providing Proposed Information Collection; 2. MAIWAND EXIM PRIVATE Comment Request financial or technological support for or LIMITED, F–1129, Chitranjan Park, New to, or providing goods or services in Delhi 110019, India; Company Number AGENCY: Internal Revenue Service (IRS), support of, the international narcotics U51909DL2006PTC14620 (India); alt. Treasury. trafficking activities of Jasmeet Company Number ACTION: Notice and request for HAKIMZADA, a significant foreign U51909DL2006PTC146202 (India) comments. narcotics trafficker designated by the [SDNTK] (Linked To: HAKIMZADA, Secretary of the Treasury pursuant to Jasmeet; Linked To: HAKIMZADA, SUMMARY: The Internal Revenue Service, the Kingpin Act; also designated Harmohan). Designated pursuant to as part of its continuing effort to reduce pursuant to section 805(b)(3) of the section 805(b)(3) of the Kingpin Act for paperwork and respondent burden, Kingpin Act for being owned, being owned, controlled, or directed by, invites the general public and other controlled, or directed by, or acting for or acting for or on behalf of Jasmeet Federal agencies to take this or on behalf of, Jasmeet HAKIMZADA, HAKIMZADA, a significant foreign opportunity to comment on proposed a significant foreign narcotics trafficker narcotics trafficker designated by the and/or continuing information designated by the Secretary of the Secretary of the Treasury pursuant to collections, as required by the Treasury pursuant to the Kingpin Act. the Kingpin Act, and Harmohan Paperwork Reduction Act of 1995. 3. KAUR, Eljeet (a.k.a. HAKIMZADA HAKIMZADA, a foreign person DATES: Written comments should be KAUR, Eljeet), Flat 17, 2nd FL Atlas designated by the Secretary of the received on or before April 29, 2019 to Tower, Jamal Abdud Nasir Rd., Sharjah, Treasury pursuant to the Kingpin Act. be assured of consideration. United Arab Emirates; DOB 03 May 3. MAIWAND TOBACCO LIMITED, ADDRESSES: Direct all written comments 1959; nationality India; Gender Female; E–70 1st Floor Greater Kailash Part II, to Laurie Brimmer, Internal Revenue Passport Z2525822 (India) (individual) New Delhi 110048, India; Company Service, Room 6526, 1111 Constitution [SDNTK] (Linked To: HAKIMZADA, Number Ul6003DL2005PLC140650 Avenue NW, Washington, DC 20224. Jasmeet). Designated pursuant to section (India); alt. Company Number Please send separate comments for each 805(b)(3) of the Kingpin Act for being U16003DL200PLC140650 (India) specific information collection listed owned, controlled, or directed by, or [SDNTK] (Linked To: HAKIMZADA, below. You must reference the acting for or on behalf of, Jasmeet Jasmeet; Linked To: HAKIMZADA, information collection’s title, form HAKIMZADA, a significant foreign Harmohan). Designated pursuant to number, reporting or record-keeping narcotics trafficker designated by the section 805(b)(3) of the Kingpin Act for requirement number, and OMB number Secretary of the Treasury pursuant to being owned, controlled, or directed by, (if any) in your comment. the Kingpin Act, and Harmohan or acting for or on behalf of Jasmeet HAKIMZADA, a foreign person HAKIMZADA, a significant foreign FOR FURTHER INFORMATION CONTACT: To designated by the Secretary of the narcotics trafficker designated by the obtain additional information, or copies Treasury pursuant to the Kingpin Act. Secretary of the Treasury pursuant to of the information collection and the Kingpin Act, and Harmohan instructions, or copies of any comments Entities HAKIMZADA, a foreign person received, contact LaNita Van Dyke, at 1. MAIWAND GENERAL TRADING designated by the Secretary of the (202) 317–6009, at Internal Revenue CO LLC, API Building, 2nd Floor, Suite Treasury pursuant to the Kingpin Act. Service, Room 6526, 1111 Constitution 202, Deira, Dubai, United Arab 4. MAIWAND BEVERAGES LIMITED, Avenue NW, Washington, DC 20224, or Emirates; Business Registration Number S–439, Greater Kailash Part II, New through the internet, at 229172 (United Arab Emirates) [SDNTK] Delhi 110048, India; Company Number [email protected]. (Linked To: HAKIMZADA, Jasmeet; U51900DL2012PLC23061 (India); alt. SUPPLEMENTARY INFORMATION:

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Request for Comments: Comments in the administration of any internal Affected Public: Individuals or submitted in response to this notice will revenue law. Generally, tax returns and households, business or other for-profit be summarized and/or included in our tax return information are confidential, organizations, and farms. request for Office of Management and as required by 26 U.S.C. 6103. Estimated Number of Respondents: Budget (OMB) approval of the relevant Approved: February 19, 2019. 300,000. Estimated Time per Respondent: 7 hr., information collection. All comments Laurie Brimmer, will become a matter of public record. 53 min. Senior Tax Analyst. Please do not include any confidential Estimated Total Annual Burden or inappropriate material in your [FR Doc. 2019–03216 Filed 2–25–19; 8:45 am] Hours: 2,370,600. comments. BILLING CODE 4830–01–P The following paragraph applies to all We invite comments on: (a) Whether of the collections of information covered the collection of information is by this notice: necessary for the proper performance of DEPARTMENT OF THE TREASURY An agency may not conduct or sponsor, and a person is not required to the agency’s functions, including Internal Revenue Service whether the information has practical respond to, a collection of information utility; (b) the accuracy of the agency’s Proposed Collection; Comment unless the collection of information estimate of the burden of the collection Request for Form 8582–CR displays a valid OMB control number. of information; (c) ways to enhance the Books or records relating to a collection quality, utility, and clarity of the AGENCY: Internal Revenue Service (IRS), of information must be retained as long information to be collected; (d) ways to Treasury. as their contents may become material minimize the burden of the collection of ACTION: Notice and request for in the administration of any internal information on respondents, including comments. revenue law. Generally, tax returns and the use of automated collection tax return information are confidential, techniques or other forms of information SUMMARY: The Internal Revenue Service, as required by 26 U.S.C. 6103. technology; and (e) estimates of capital as part of its continuing effort to reduce Request for Comments: Comments or start-up costs and costs of operation, paperwork and respondent burden, submitted in response to this notice will maintenance, and purchase of services invites the general public and other be summarized and/or included in the to provide the requested information. Federal agencies to take this request for OMB approval. All Currently, the IRS is seeking opportunity to comment on proposed comments will become a matter of comments concerning the following and/or continuing information public record. Comments are invited on: form, and reporting and record-keeping collections, as required by the (a) Whether the collection of requirements: Paperwork Reduction Act of 1995. information is necessary for the proper 1. Title: Notification of Distribution Currently, the IRS is soliciting performance of the functions of the From a Generation-Skipping Trust. comments concerning Form 8582–CR, agency, including whether the OMB Number: 1545–1143. Passive Activity Credit Limitations. information shall have practical utility; Form Number: 706–GS(D–1). DATES: Written comments should be (b) the accuracy of the agency’s estimate Abstract: Form 706–GS(D–1) is used received on or before April 29, 2019. to of the burden of the collection of by trustees to provide information to the be assured of consideration. information; (c) ways to enhance the IRS and to distributees regarding ADDRESSES: Direct all written comments quality, utility, and clarity of the generation-skipping distributions from to Laurie Brimmer, Internal Revenue information to be collected; (d) ways to trusts. The information is needed by Service, Room 6526, 1111 Constitution minimize the burden of the collection of distributees to compute the generation- Avenue NW, Washington, DC 20224. information on respondents, including skipping tax imposed by Internal through the use of automated collection FOR FURTHER INFORMATION CONTACT: Revenue Code section 2601. The IRS techniques or other forms of information Requests for additional information or uses the information to verify that the technology; and (e) estimates of capital copies of the form and instructions tax has been properly computed. or start-up costs and costs of operation, should be directed to LaNita Van Dyke, Current Actions: There are no changes maintenance, and purchase of services at (202)317–6009, at Internal Revenue being made to the form at this time. to provide information. Type of Review: Extension of a Service, Room 6526, 1111 Constitution Approved: February 19, 2019. currently approved collection. Avenue NW, Washington, DC 20224, or Affected Public: Individuals or through the internet at Laurie Brimmer, households. [email protected]. Senior Tax Analyst. Estimated Number of Respondents: SUPPLEMENTARY INFORMATION: [FR Doc. 2019–03219 Filed 2–25–19; 8:45 am] 80,000. Title: Passive Activity Credit BILLING CODE 4830–01–P Estimated Time per Respondent: 4 Limitations. hours, 22 minutes. OMB Number: 1545–1034. Estimated Total Annual Burden Form Number: 8582–CR. DEPARTMENT OF THE TREASURY Hours: 348,800. Abstract: Under Internal Revenue The following paragraph applies to all Code section 469, credits from passive Internal Revenue Service of the collections of information covered activities, to the extent they do not Proposed Collection: Comment by this notice: exceed the tax attributable to net passive Request for Form 4669 An agency may not conduct or income, are not allowed, Form 8582–CR sponsor, and a person is not required to is used to figure the passive activity AGENCY: Internal Revenue Service (IRS), respond to, a collection of information credit allowed and the amount of credit Treasury. unless the collection of information to be reported on the tax return. ACTION: Notice and request for displays a valid OMB control number. Current Actions: There are no changes comments. Books or records relating to a collection being made to the form at this time. of information must be retained as long Type of Review: Extension of a SUMMARY: The Internal Revenue Service, as their contents may become material currently approved collection. as part of its continuing effort to reduce

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paperwork and respondent burden, Books or records relating to a collection FOR FURTHER INFORMATION CONTACT: invites the general public and other of information must be retained as long Requests for additional information or Federal agencies to take this as their contents may become material copies of this regulation should be opportunity to comment on proposed in the administration of any internal directed to Sara Covington, (202) 317– and/or continuing information revenue law. Generally, tax returns and 6038, at Internal Revenue Service, Room collections, as required by the tax return information are confidential, 6526, 1111 Constitution Avenue NW, Paperwork Reduction Act of 1995. as required by 26 U.S.C. 6103. Washington, DC 20224, or through the Currently, the IRS is soliciting Request for Comments: Comments internet, at [email protected]. comments concerning Form 4669, submitted in response to this notice will SUPPLEMENTARY INFORMATION: Statement of Payments Received. be summarized and/or included in the Title: Section 6662—Imposition of the DATES: Written comments should be request for OMB approval. All Accuracy-Related Penalty. received on or before April 29, 2019. to comments will become a matter of OMB Number: 1545–1426. be assured of consideration. public record. Comments are invited on: Regulation Project Number: TD 8656. ADDRESSES: Direct all written comments (a) Whether the collection of Abstract: These regulations provide to Laurie Brimmer, Internal Revenue information is necessary for the proper guidance on the accuracy-related Service, Room 6526, 1111 Constitution performance of the functions of the penalty imposed on underpayments of Avenue NW, Washington, DC 20224. agency, including whether the tax caused by substantial and gross information shall have practical utility; FOR FURTHER INFORMATION CONTACT: valuation misstatements as defined in (b) the accuracy of the agency’s estimate Requests for additional information or Internal Revenue Code sections 6662(e) of the burden of the collection of copies of the form and instructions and 6662(h). Under section 1.6662–6(d) information; (c) ways to enhance the should be directed to LaNita Van Dyke, of the regulations, an amount is quality, utility, and clarity of the at (202) 317–6009 at Internal Revenue excluded from the penalty if certain information to be collected; (d) ways to Service, Room 6526, 1111 Constitution requirements are met and a taxpayer minimize the burden of the collection of Avenue NW, Washington DC 20224, or maintains documentation of how a information on respondents, including through the internet, at transfer price was determined for a through the use of automated collection [email protected]. transaction subject to Code section 482. techniques or other forms of information Current Actions: There is no changes SUPPLEMENTARY INFORMATION: technology; and (e) estimates of capital Title: Statement of Payments in the paperwork burden previously or start-up costs and costs of operation, approved by OMB. Received. maintenance, and purchase of services OMB Number: 1545–0364. Type of Review: Extension of a to provide information. Form Number: 4669. currently approved collection. Abstract: Form 4669 is used by payors Approved: February 19, 2019. Affected Public: Business or other for- in specific situations to request relief Laurie Brimmer, profit organizations. from payment of certain required taxes. Senior Tax Analyst. Estimated Number of Respondents: 2,500. A payor who fails to withhold certain [FR Doc. 2019–03220 Filed 2–25–19; 8:45 am] Estimated Time per Respondent: 8 required taxes from a payee may be BILLING CODE 4830–01–P entitled to relief, under sections hours, 3 minutes. 3402(d), 3102(f)(3), 1463 or Regulations Estimated Total Annual Burden section 1.1474–4. To apply for relief, a DEPARTMENT OF THE TREASURY Hours: 20,125. payor must show that the payee The following paragraph applies to all reported the payments and paid the Internal Revenue Service of the collections of information covered corresponding tax. To secure relief as by this notice: described above, a payor must obtain a Proposed Collection; Comment An agency may not conduct or separate, completed Form 4669 from Request for TD 8656 sponsor, and a person is not required to each payee for each year relief is respond to, a collection of information AGENCY: Internal Revenue Service (IRS), unless the collection of information requested. Treasury. Current Actions There are no changes displays a valid OMB control number. ACTION: being made to the Omnibus Survey at Notice and request for Books or records relating to a this time. comments. collection of information must be retained as long as their contents may Type of Review: Extension without SUMMARY: The Internal Revenue Service, change of a currently approved become material in the administration as part of its continuing effort to reduce of any internal revenue law. Generally, collection. paperwork and respondent burden, Affected Public: Business or other for- tax returns and tax return information invites the general public and other are confidential, as required by 26 profit organizations. Federal agencies to take this Estimated Number of Respondents: U.S.C. 6103. opportunity to comment on information Request for Comments: Comments 85,000. collections, as required by the Estimated Time per Response: 15 submitted in response to this notice will Paperwork Reduction Act of 1995. The minutes. be summarized and/or included in the IRS is soliciting comments concerning Estimated Total Annual Burden request for OMB approval. All final regulation TD 8656, Imposition of Hours: 21,250. comments will become a matter of the Accuracy-Related Penalty. The following paragraph applies to all public record. Comments are invited on: of the collections of information covered DATES: Written comments should be (a) Whether the collection of by this notice: received on or before April 29, 2019 to information is necessary for the proper An agency may not conduct or be assured of consideration. performance of the functions of the sponsor, and a person is not required to ADDRESSES: Direct all written comments agency, including whether the respond to, a collection of information to L. Brimmer, Internal Revenue information shall have practical utility; unless the collection of information Service, Room 6526, 1111 Constitution (b) the accuracy of the agency’s estimate displays a valid OMB control number. Avenue NW, Washington, DC 20224. of the burden of the collection of

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information; (c) ways to enhance the individual retirement account trust to be DEPARTMENT OF THE TREASURY quality, utility, and clarity of the used by their employees. The information to be collected; (d) ways to application is also used by banks and Internal Revenue Service minimize the burden of the collection of insurance companies that want to information on respondents, including establish approved prototype individual Proposed Collection; Comment through the use of automated collection retirement accounts or annuities. The Request for Revenue Ruling 2000–35 techniques or other forms of information data collected is used to determine if the AGENCY: Internal Revenue Service (IRS), technology; and (e) estimates of capital individual retirement account trust or Treasury. or start-up costs and costs of operation, annuity contract meets the requirements ACTION: Notice and request for maintenance, and purchase of services of Code section 408(a), 408(b), or 408(c) comments. to provide information. so that the IRS may issue an approval Approved: February 20, 2019. letter. SUMMARY: The Internal Revenue Service, Current Actions: There are no changes Laurie Brimmer, as part of its continuing effort to reduce being made to the form at this time. Senior Tax Analyst. paperwork and respondent burden, Type of Review: Extension of a invites the general public and other [FR Doc. 2019–03213 Filed 2–25–19; 8:45 am] currently approved collection. Federal agencies to take this BILLING CODE 4830–01–P Affected Public: Business or other for- opportunity to comment on proposed profit organizations. and/or continuing information Estimated Number of Respondents: DEPARTMENT OF THE TREASURY collections, as required by the 600. Paperwork Reduction Act of 1995. Estimated Time Per Respondent: 13 Internal Revenue Service Currently, the IRS is soliciting hr., 45 min. comments concerning Revenue Ruling Proposed Collection; Comment Estimated Total Annual Burden 2000–35, Automatic Enrollment in Request for Form 5306 Hours: 8,244. Section 403(b) Plans. The following paragraph applies to all DATES: Written comments should be AGENCY: Internal Revenue Service (IRS), of the collections of information covered received on or before April 29, 2019 to Treasury. by this notice: be assured of consideration. ACTION: Notice and request for An agency may not conduct or ADDRESSES: Direct all written comments comments. sponsor, and a person is not required to respond to, a collection of information to Laurie Brimmer, Internal Revenue SUMMARY: The Internal Revenue Service, unless the collection of information Service, Room 6526, 1111 Constitution as part of its continuing effort to reduce displays a valid OMB control number. Avenue NW, Washington, DC 20224. paperwork and respondent burden, Books or records relating to a collection FOR FURTHER INFORMATION CONTACT: invites the general public and other of information must be retained as long Requests for additional information or Federal agencies to take this as their contents may become material copies of the form and instructions opportunity to comment on proposed in the administration of any internal should be directed to LaNita Van Dyke, and/or continuing information revenue law. Generally, tax returns and at (202) 317–6009, at Internal Revenue collections, as required by the tax return information are confidential, Service, Room 6526, 1111 Constitution Paperwork Reduction Act of 1995. as required by 26 U.S.C. 6103. Avenue NW, Washington, DC 20224, or Currently, the IRS is soliciting Request for Comments: Comments through the internet at comments concerning Form 5306, submitted in response to this notice will [email protected]. Application for Approval of Prototype be summarized and/or included in the SUPPLEMENTARY INFORMATION: or Employer Sponsored Individual request for OMB approval. All Title: Automatic Enrollment in Retirement Account. comments will become a matter of Section 403(b) Plans. DATES: Written comments should be public record. Comments are invited on: OMB Number: 1545–1694. received on or before April 29, 2019] to (a) Whether the collection of Form Number: Revenue Ruling 2000– be assured of consideration. information is necessary for the proper 35. performance of the functions of the Abstract: Revenue Ruling 2000–35 ADDRESSES: Direct all written comments to Laurie Brimmer, Internal Revenue agency, including whether the describes certain criteria that must be Service, Room 6526, 1111 Constitution information shall have practical utility; met before an employee’s compensation Avenue NW, Washington, DC 20224. (b) the accuracy of the agency’s estimate can be reduced and contributed to an of the burden of the collection of employee’s section 403(b) plan in the FOR FURTHER INFORMATION CONTACT: information; (c) ways to enhance the absence of an affirmative election by the Requests for additional information or quality, utility, and clarity of the employee. copies of the form and instructions information to be collected; (d) ways to Current Actions: There is no change should be directed to LaNita Van Dyke, minimize the burden of the collection of in the paperwork burden previously at (202) 317–6009, at Internal Revenue information on respondents, including approved by OMB. This form is being Service, Room 6526, 1111 Constitution through the use of automated collection submitted for renewal purposes only. Avenue NW, Washington, DC 20224, or techniques or other forms of information Type of Review: Extension of a through the internet, at technology; and (e) estimates of capital currently approved collection. [email protected]. or start-up costs and costs of operation, Affected Public: Not-for-profit SUPPLEMENTARY INFORMATION: maintenance, and purchase of services institutions, and state, local or tribal Title: Application for Approval of to provide information. governments. Prototype or Employer Sponsored Estimated Number of Respondents: Approved: February 19, 2019. Individual Retirement Account (IRA). 200. OMB Number: 1545–0390. Laurie Brimmer, Estimated Time per Respondent: 53 Form Number: 5306. Senior Tax Analyst. minutes. Abstract: This application is used by [FR Doc. 2019–03222 Filed 2–25–19; 8:45 am] Estimated Total Annual Burden employers who want to establish an BILLING CODE 4830–01–P Hours: 175.

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The following paragraph applies to all DATES: Written comments should be information shall have practical utility; of the collections of information covered received on or before April 29, 2019 to (b) the accuracy of the agency’s estimate by this notice: be assured of consideration. of the burden of the collection of An agency may not conduct or ADDRESSES: Direct all written comments information; (c) ways to enhance the sponsor, and a person is not required to to Laurie Brimmer, Internal Revenue quality, utility, and clarity of the respond to, a collection of information Service, Room 6529, 1111 Constitution information to be collected; (d) ways to unless the collection of information Avenue NW, Washington, DC 20224. minimize the burden of the collection of displays a valid OMB control number. FOR FURTHER INFORMATION CONTACT: information on respondents, including Books or records relating to a collection Requests for additional information or through the use of automated collection of information must be retained as long copies of the form should be directed to techniques or other forms of information as their contents may become material Kerry Dennis, at (202) 317–5751 or technology; and (e) estimates of capital in the administration of any internal Internal Revenue Service, Room 6529, or start-up costs and costs of operation, revenue law. Generally, tax returns and 1111 Constitution Avenue NW, maintenance, and purchase of services tax return information are confidential, Washington DC 20224, or through the to provide information. as required by 26 U.S.C. 6103. internet, at [email protected]. Approved: February 20, 2019. Request for Comments: Comments submitted in response to this notice will SUPPLEMENTARY INFORMATION: Laurie Brimmer, be summarized and/or included in the Title: Taxable Distributions Received Senior Tax Analyst. request for OMB approval. All From Cooperatives. [FR Doc. 2019–03221 Filed 2–25–19; 8:45 am] comments will become a matter of OMB Number: 1545–0118. BILLING CODE 4830–01–P public record. Comments are invited on: Form Number: 1099–PATR. (a) Whether the collection of Abstract: Form 1099–PATR is used to information is necessary for the proper report patronage dividends paid by DEPARTMENT OF THE TREASURY performance of the functions of the cooperatives in accordance with Internal Revenue Service agency, including whether the Internal Revenue Code section 6044. information shall have practical utility; The information is used by IRS to verify reporting compliance on the part of the Proposed Collection; Comment (b) the accuracy of the agency’s estimate Request for Form 706–GS(T) of the burden of the collection of recipient. Current Actions: There have been no information; (c) ways to enhance the AGENCY: Internal Revenue Service (IRS), changes to the form that would affect quality, utility, and clarity of the Treasury. burden. However, the agency has information to be collected; (d) ways to ACTION: Notice and request for updated the estimated number of minimize the burden of the collection of comments. responses based on its most recent filing information on respondents, including data. through the use of automated collection SUMMARY: The Internal Revenue Service Type of Review: Revision of a techniques or other forms of information (IRS), as part of its continuing effort to currently approved collection. technology; and (e) estimates of capital reduce paperwork and respondent Affected Public: Business or other for- or start-up costs and costs of operation, burden, invites the general public and profit organizations. maintenance, and purchase of services other Federal agencies to take this Estimated Number of Respondents: to provide information. opportunity to comment on information 1,820,000. collections, as required by the Approved: February 20, 2019 Estimated Time per Respondent: 15 Paperwork Reduction Act of 1995. The Laurie Brimmer, minutes. IRS is soliciting comments concerning Senior Tax Analyst. Estimated Total Annual Burden Generation-Skipping Transfer Tax [FR Doc. 2019–03214 Filed 2–25–19; 8:45 am] Hours: 455,000. Return For Terminations. The following paragraph applies to all BILLING CODE 4830–01–P DATES: Written comments should be of the collections of information covered received on or before April 29, 2019 to by this notice. be assured of consideration. DEPARTMENT OF THE TREASURY An agency may not conduct or sponsor, and a person is not required to ADDRESSES: Direct all written comments Internal Revenue Service respond to, a collection of information to Laurie Brimmer, Internal Revenue unless the collection of information Service, Room 6526, 1111 Constitution Proposed Collection; Comment displays a valid OMB control number. Avenue NW, Washington, DC 20224. Request for Regulation Project Books or records relating to a collection FOR FURTHER INFORMATION CONTACT: AGENCY: Internal Revenue Service (IRS), of information must be retained as long Requests for additional information or Treasury. as their contents may become material copies of the form and instructions should be directed to Martha R. Brinson, ACTION: Notice and request for in the administration of any internal at (202)317–5753, or at Internal Revenue comments. revenue law. Generally, tax returns and tax return information are confidential, Service, Room 6526, 1111 Constitution SUMMARY: The Internal Revenue Service, as required by 26 U.S.C. 6103. Avenue NW, Washington, DC 20224, or as part of its continuing effort to reduce Request for Comments: Comments through the internet at paperwork and respondent burden, submitted in response to this notice will [email protected]. invites the general public and other be summarized and/or included in the SUPPLEMENTARY INFORMATION: Federal agencies to take this request for OMB approval. All Title: Generation-Skipping Transfer opportunity to comment on continuing comments will become a matter of Tax Return For Terminations. information collections, as required by public record. Comments are invited on: OMB Number: 1545–1145. the Paperwork Reduction Act of 1995. (a) Whether the collection of Form Number: 706–GS(T). The IRS is soliciting comments information is necessary for the proper Abstract: Form 706–GS(T) is used by concerning taxable distributions performance of the functions of the trustees to compute and report the tax received from cooperatives. agency, including whether the due on generation-skipping transfers

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that result from the termination of An agency may not conduct or performance of the functions of the interests in a trust. The IRS uses the sponsor, and a person is not required to agency, including whether the information to verify that the tax has respond to, a collection of information information has practical utility; (b) the been properly computed. unless the collection of information accuracy of the agency’s estimate of the Current Actions: There are no changes displays a valid OMB control number. burden of the collection of information; being made to the form at this time. Books or records relating to a collection (c) ways to enhance the quality, utility, Type of Review: Extension of a of information must be retained as long and clarity of the information to be currently approved collection. as their contents may become material collected; (d) ways to minimize the Affected Public: Individuals or in the administration of any internal burden of the collection of information households. revenue law. Generally, tax returns and on or other forms of information Estimated Number of Respondents: tax return information are confidential, technology; and (e) estimates of capital 500. as required by 26 U.S.C. 6103. or start-up costs and costs of operation, maintenance, and purchase of services Estimated Number of Responses: 1 Request for Comments: Comments to provide information. hour, 22 minutes. submitted in response to this notice will Estimated Total Annual Burden be summarized and/or included in the Approved: February 19, 2019. Hours: 684. request for OMB approval. Comments Laurie Brimmer, The following paragraph applies to all will be of public record. Comments are Senior Tax Analyst. of the collections of information covered invited on: (a) Whether the collection of [FR Doc. 2019–03212 Filed 2–25–19; 8:45 am] by this notice: information is necessary for the proper BILLING CODE 4830–01–P

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Part II

Department of Health and Human Services

Food and Drug Administration 21 CFR Parts 201, 310, 347, et al. Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Rule

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DEPARTMENT OF HEALTH AND the public. Similarly, if your submission 1978–N–0018 (formerly Docket No. HUMAN SERVICES includes safety and effectiveness data or FDA–1978–N–0038) for ‘‘Sunscreen information marked as confidential by a Drug Products for Over-the-Counter Food and Drug Administration third party (such as a contract research Human Use.’’ Received comments, those organization or consultant), you should filed in a timely manner (see 21 CFR Parts 201, 310, 347, and 352 either include a statement that you are ADDRESSES), will be placed in the docket [Docket No. FDA–1978–N–0018] (Formerly authorized to make the information and, except for those submitted as Docket No. FDA–1978–N–0038) publicly available or include an ‘‘Confidential Submissions,’’ publicly authorization from the third party viewable at https://www.regulations.gov RIN 0910–AF43 permitting the information to be or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday Sunscreen Drug Products for Over-the- publicly disclosed. If you submit data through Friday. Counter Human Use without confidential markings in response to this document and such • Confidential Submissions—To AGENCY: Food and Drug Administration, data includes studies or other submit a comment with confidential HHS. information that were previously information that you do not wish to be made publicly available, submit your ACTION: Proposed rule. submitted confidentially (e.g., as part of a new drug application), FDA intends to comments only as a written/paper SUMMARY: The Food and Drug presume that you intend to make such submission. You should submit two Administration (FDA or Agency) is data publicly available. copies total. One copy will include the issuing this proposed rule to put into information you claim to be confidential effect a final monograph for Electronic Submissions with a heading or cover note that states nonprescription, over-the-counter (OTC) Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS sunscreen drug products. This proposed following way: CONFIDENTIAL INFORMATION.’’ The rule describes the conditions under • Federal eRulemaking Portal: Agency will review this copy, including which FDA proposes that OTC https://www.regulations.gov. Follow the the claimed confidential information, in sunscreen monograph products are instructions for submitting comments. its consideration of comments. The generally recognized as safe and Comments submitted electronically, second copy, which will have the effective (GRASE) and not misbranded. including attachments, to https:// claimed confidential information It is being published as part of the www.regulations.gov will be posted to redacted/blacked out, will be available ongoing review of OTC drug products the docket unchanged. Because your for public viewing and posted on conducted by FDA. It is also being comment will be made public, you are https://www.regulations.gov. Submit published to comply with the Federal solely responsible for ensuring that your both copies to the Dockets Management Food, Drug, and Cosmetic Act (FD&C comment does not include any Staff. If you do not wish your name and Act), as amended by the Sunscreen confidential information that you or a contact information to be made publicly Innovation Act (SIA). third party may not wish to be posted, available, you can provide this information on the cover sheet and not DATES: Submit either electronic or such as medical information, your or in the body of your comments and you written comments. on the proposed rule anyone else’s Social Security number, or must identify this information as by May 28, 2019. Electronic comments confidential business information, such ‘‘confidential.’’ Any information marked must be submitted on or before May 28, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed 2019. The https://www.regulations.gov that if you include your name, contact except in accordance with 21 CFR 10.20 electronic filing system will accept information, or other information that and other applicable disclosure law. For comments until 11:59 p.m. Eastern Time identifies you in the body of your comments, that information will be more information about FDA’s posting at the end of May 28, 2019. See section of comments to public dockets, see 80 XII for proposed effective and posted on https://www.regulations.gov. • If you want to submit a comment FR 56469, September 18, 2015, or access compliance dates of a final rule based the information at: https://www.gpo.gov/ on this document. with confidential information that you do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- ADDRESSES: You may submit comments public, submit the comment as a 23389.pdf. as follows. Please note that late, written/paper submission and in the Docket: For access to the docket to untimely filed comments will not be manner detailed (see ‘‘Written/Paper read background documents or the considered. Comments received by Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments mail/hand delivery/courier (for written/ received, go to https:// paper submissions) will be considered Written/Paper Submissions www.regulations.gov and insert the timely if they are postmarked or the Submit written/paper submissions as docket number, found in brackets in the delivery service acceptance receipt is on follows: heading of this document, into the or before the closing date. • Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts Please be advised that safety and written/paper submissions): Dockets and/or go to the Dockets Management effectiveness data that are not available Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, to the public cannot be relied on to Drug Administration, 5630 Fishers Rockville, MD 20852. establish conditions under which the Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information OTC drugs described in this document • For written/paper comments collection issues under the Paperwork of proposed rulemaking are generally submitted to the Dockets Management Reduction Act of 1995 to the Office of recognized as safe and effective. Staff, FDA will post your comment, as Management and Budget (OMB) in the Accordingly, you should not submit, well as any attachments, except for following ways: and FDA generally does not intend to information submitted, marked and • Fax to the Office of Information and rely on, any evidence of safety and identified, as confidential, if submitted Regulatory Affairs, OMB, Attn: FDA effectiveness that bears a confidential as detailed in ‘‘Instructions.’’ Desk Officer, Fax: 202–395–7285, or mark unless you include a statement Instructions: All submissions received email to [email protected]. that the information may be released to must include the Docket No. FDA– All comments should be identified with

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the title, ‘‘Sunscreen Drug Products for B. Regulatory Status of Testing Entities changed conditions, including Over-the-Counter Human Use.’’ C. Generating and Maintaining Records of substantially increased sunscreen usage The Agency encourages commenters SPF and Broad Spectrum Testing and exposure and evolving information XVI. Federalism also to submit their comments on these XVII. Consultation and Coordination With about the potential risks associated with paperwork requirements to the Indian Tribal Governments these products since they were rulemaking docket (Docket No. FDA– XVIII. References originally evaluated. While these 1978–N–0018), along with their additional data are being developed and comments on other parts of the I. Executive Summary reviewed, FDA generally intends to proposed rule. A. Purpose and Coverage of the follow the enforcement approach FOR FURTHER INFORMATION CONTACT: Proposed Rule discussed in section III.B with regard to sunscreen products that contain those Kristen Hardin, Center for Drug The Food and Drug Administration Evaluation and Research, Food and (FDA or Agency) is publishing this sunscreen active ingredients included in Drug Administration, 10903 New proposed rule as part of the regulatory the Stayed 1999 Final Monograph. This proposed rule is also being Hampshire Ave., Bldg. 22, Rm. 5443, proceeding to put into effect a final published to comply with section 586E Silver Spring, MD 20993, 240–402– monograph 1 for nonprescription, OTC of the FD&C Act (21 U.S.C. 360fff–5), as 4246. sunscreen drug products under the OTC amended by the SIA (21 U.S.C. ch. 9, Drug Review. In 2011, FDA announced SUPPLEMENTARY INFORMATION: sub. 5, part I, enacted November 26, that ‘‘we are considering certain active Table of Contents ingredient safety issues further . . . In 2014). The SIA calls for FDA to issue a a forthcoming rulemaking, we intend to final OTC sunscreen monograph to be I. Executive Summary effective within 5 years of enactment of A. Purpose and Coverage of the Proposed request additional data regarding the Rule safety of the individual sunscreen active the SIA, or by November 26, 2019 B. Summary of the Major Provisions of the ingredients.’’ (‘‘Revised Effectiveness (section 586E(a) of the FD&C Act). If the Proposed Rule Determination; Sunscreen Drug final OTC sunscreen monograph does C. Legal Authority Products for Over-the-Counter Human not include provisions related to the D. Costs and Benefits Use’’ (Max SPF PR), 76 FR 35672 at effectiveness of various sun protection II. Table of Abbreviations/Commonly Used 35673, June 17, 2011). As described in factor (SPF) levels and address all Acronyms in This Document dosage forms known to FDA to be used III. Background further detail below, changed conditions in the nearly 20 years since publication in sunscreens marketed in the United A. FDA’s Current Regulatory Framework States without approved new drug B. History of This Rulemaking of the final rule ‘‘Sunscreen Drug IV. Scope of This Rulemaking Products for Over the Counter Human applications (NDAs), the SIA requires V. Legal Authority Use’’ (64 FR 27666, May 21, 1999) (now FDA, among other things, to submit a VI. Need for Additional Safety Information stayed) (Stayed 1999 Final Monograph) report to Congress explaining these A. Increased Consumer Exposure to have meant that additional safety data omissions (section 586E(b) of the FD&C Sunscreen Active Ingredients are now needed to establish that certain Act). As explained in section I.B, in this B. Emerging Safety Concerns of the active ingredients listed in the proposed rule, FDA is addressing VII. Framework for Evaluation of Safety Data multiple conditions of use applicable to A. General Stayed 1999 Final Monograph are GRASE for use in sunscreen products.2 sunscreen monograph products, B. Clinical Safety Testing including both the effectiveness of C. Nonclinical Safety Testing As detailed below, we emphasize that D. Postmarketing Safety Data this proposed rule does not represent a various SPF values and all marketed E. Sunscreens Containing Nanomaterials conclusion by FDA that the sunscreen sunscreen dosage forms (and intends to VIII. Existing Safety Data for Sunscreen active ingredients included in the do so in the final rule as well). Active Ingredients Stayed 1999 Final Monograph but This proposed rule does not address A. Ingredients Proposed as Category I proposed here as Category III are unsafe the sunscreen active ingredients that B. Ingredients Proposed as Category II for use in sunscreens. Rather, we are were originally submitted under the C. Ingredients Proposed as Category III requesting additional information on procedures established in FDA’s time D. Anticipated Final Formulation In Vitro these ingredients so that we can and extent application (TEA) regulation Permeation Testing evaluate their GRASE status in light of (§ 330.14 (21 CFR 330.14)) (67 FR 3074, IX. Additional Proposed Conditions of Use January 23, 2002), and are now being A. Proposed Requirements Related to Dosage Form 1 An OTC monograph establishes conditions addressed through a process set forth in B. Proposed Maximum SPF and Broad under which certain OTC drugs may be marketed the SIA. without approved new drug applications because Spectrum Requirements they are generally recognized as safe and effective B. Summary of the Major Provisions of C. Proposed PDP Labeling Requirements (GRASE) and not misbranded. The proposed rule the Proposed Rule D. Proposed Requirements Related to Final classifies active ingredients and other conditions as Formulation Testing and Recordkeeping Category I (proposed to be GRASE and not 1. Proposed GRASE Status of Active E. Proposed Status of Sunscreen-Insect misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III Ingredients Listed in the Stayed 1999 Repellent Combination Products Final Monograph X. Proposed Actions To Effectuate Lifting of (additional data needed). 2 Stay and Harmonize Impacted Unless otherwise noted, references in this a. Framework for evaluation of safety proposed rule to sunscreen active ingredients and/ Regulations or sunscreen products are to sunscreen active data. As previously noted, changed XI. Comment Period ingredients or products marketed pursuant to the conditions in the time since issuance of XII. Proposed Effective/Compliance Dates OTC monograph system and subject to 21 CFR the Stayed 1999 Final Monograph have XIII. Preliminary Economic Analysis of 201.327. Unless specifically noted, references to meant that additional safety data are sunscreen active ingredients and/or sunscreen Impacts now needed to establish that certain of A. Introduction products in this notice do not refer to those B. Summary of Costs and Benefits marketed pursuant to a new drug application (NDA) the active ingredients listed in the or an abbreviated new drug application (ANDA). XIV. Analysis of Environmental Impact Stayed 1999 Final Monograph are They also do not refer to sunscreen active GRASE for use in sunscreen products in XV. Paperwork Reduction Act of 1995 ingredients being evaluated under the new A. Labeling for Sunscreen Products and procedures set out in the SIA (21 U.S.C. 360fff et accordance with the standards Associated Clinical Testing seq). established in § 330.10(a)(4) (21 CFR

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330.10(a)(4)). FDA’s approach to the proposing that these two ingredients are 3. Proposed Maximum Sun Protection clinical safety evaluation of OTC Category II. Factor and Broad Spectrum sunscreen active ingredients is based on Because the public record does not Requirements our current scientific understanding currently contain sufficient data to In the Stayed 1999 Final Monograph, support positive GRASE determinations regarding the safety evaluation of FDA established SPF 30+ as the for cinoxate, dioxybenzone, ensulizole, topical drug products for chronic use, maximum labeled SPF value for homosalate, meradimate, octinoxate, and is therefore generally consistent sunscreen monograph products, and octisalate, octocrylene, padimate O, with the safety data needed to meet the subsequently proposed (in 2011) to raise sulisobenzone, oxybenzone, or requirements for approval of an NDA for this value to SPF 50+. Because of avobenzone, we are proposing that these a chronic-use topical drug product (e.g., evidence showing additional ingredients are Category III. For topical safety studies (irritation, meaningful clinical benefit associated sensitization, and photosafety); example, the available literature with broad spectrum sunscreen bioavailability (absorption); and includes studies indicating that products with an SPF of 60, we are now evaluation of adverse events observed in oxybenzone is absorbed through the proposing to raise the maximum labeled clinical studies). Postmarketing safety skin to a greater extent than previously SPF value to SPF 60+. Given the lack of information is also relevant to our safety understood and can lead to significant data showing that sunscreens with SPF evaluation. systemic exposure, as well as data Our current approach to the showing the presence of oxybenzone in values above 60 provide additional nonclinical safety evaluation of these human breast milk, amniotic fluid, meaningful clinical benefit, we are active ingredients takes into account urine, and blood plasma. The significant proposing not to allow labeled SPF their lengthy marketing history in the systemic availability of oxybenzone, values higher than 60+. United States. Unlike the nonclinical coupled with a lack of data evaluating While our proposed cap for SPF data required to meet the standard for the full extent of its absorption labeling is SPF 60+, we are proposing to approval of chronic-use topical NDA potential, is a concern, among other permit the marketing of sunscreen products (which include comprehensive reasons, because of questions raised in products formulated with SPF values up nonclinical pharmacology and the published literature regarding the to 80. This formulation margin is toxicology safety testing), the approach potential for endocrine activity in intended to provide manufacturers with to nonclinical safety testing reflected in connection with systemic oxybenzone formulation flexibility that we hope this proposed rule is largely focused on exposure. Nearly all of these sunscreen will: (1) Help facilitate the development potential long-term adverse effects or active ingredients also have limited or of products with greater Ultraviolet A effects not otherwise readily detected no data characterizing their absorption. (UVA) protection and (2) more fully from human use (i.e., carcinogenicity account for the range of variability in 2. Proposed Requirements Related to and reproductive toxicity). SPF test results (discussed further in b. Existing safety data for ingredients Dosage Forms sections IX.B.4.b–c) for sunscreen listed in Stayed 1999 Final Monograph. In 2011, FDA published an Advance products labeled SPF 60+. We are In section VIII, we discuss our review of Notice of Proposed Rulemaking (ANPR) proposing not to allow the marketing the scientific literature, submissions to that identified sunscreen dosage forms (without an approved NDA) of the sunscreen monograph docket, and considered either eligible or ineligible sunscreen products with SPF values adverse event reports submitted to for inclusion in the sunscreen above SPF 80. FDA’s Adverse Event Reporting System monograph, and specifically requested In addition, since publication of the (FAERS) for the ingredients listed in the comments on the safety and efficacy of 2011 ‘‘Labeling and Effectiveness Stayed 1999 Final Monograph and spray sunscreens. After considering Testing; Sunscreen Drug Products for identify any existing gaps. Because our comments received in response (and Over-the-Counter Human Use’’ (L&E review of this evidence has produced other available data), we are proposing Final Rule) (76 FR 35620, June 17, 2011) sufficient safety data on both zinc oxide the following dosage forms as Category and Max SPF PR, the body of scientific and titanium dioxide to support a I: Oils, lotions, creams, gels, butters, evidence linking UVA exposure to skin proposal that sunscreen products pastes, ointments, and sticks. We are cancers and other harms has grown containing these ingredients (at also proposing Category I status for significantly. This evidence raises concentrations of up to 25 percent) spray sunscreens, subject to testing concerns about the potential for would be GRASE, we are proposing that necessary to minimize potential risks inadequate UVA protection in marketed these ingredients are Category I. Our from unintended inhalation (particle sunscreen products—particularly in evaluation of the available safety data size restrictions) and flammability high SPF sunscreen products that either for aminobenzoic acid (PABA) and (flammability and drying time testing), do not pass the current broad spectrum trolamine salicylate, however, has together with related labeling test or (though they pass our current caused us to conclude that the risks requirements. We are proposing to add broad spectrum test) have inadequate associated with use of these active sunscreen powders to the list of those uniformity in their UVA protection. ingredients in sunscreen products eligible for inclusion in the monograph Consumers using these products may, outweigh their benefits. In the case of and proposing that this dosage form is while successfully preventing sunburn, trolamine salicylate, these risks include Category III; we expect that powders accumulate excessively large doses of the potential for serious detrimental would also be subject to particle size UVA radiation—thereby exposing health effects (including bleeding) restrictions if found to be GRASE in the themselves to additional risks related to caused by the anti-coagulation effects of final monograph. Finally, we are skin cancer and early skin aging. salicylic acid and increased risk of proposing that sunscreens in all other To address these concerns, we are salicylate toxicity when this ingredient dosage forms—including wipes, making a number of proposals designed is used in sunscreens. For PABA, the towelettes, body washes, and to couple a greater magnitude of UVA risks include significant rates of allergic shampoos—are new drugs because we protection to increases in SPF values. and photoallergic skin reactions, as well did not receive data showing that they We are proposing to require that all as cross-sensitization with structurally were marketed prior to 1972, as required sunscreen products with SPF values of similar compounds. Accordingly, we are for inclusion in the monograph. 15 and above satisfy broad spectrum

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requirements. Among other things, this labeled in increments of 5 (i.e., SPF 15, to ensure that the testing of marketed proposal eliminates the potential SPF 20, SPF 25), and that the sunscreen products is conducted in a confusion permitted by the current requirement that labeled SPF values manner that both protects human labeling regime, in which a higher correspond to ranges (rather than subjects and produces reliable results. numbered product (for example, one precise numerical values) is not 6. Proposed Status of Sunscreen-Insect labeled SPF 30) may provide inferior necessary below SPF 15. Repellent Combination Products protection against UVA radiation than a 4. Proposed PDP Labeling Requirements lower numbered product (for example, The proposed rule also addresses one labeled broad spectrum SPF 15). We We are also proposing to partially sunscreen-insect repellent products, are also proposing to add to the current revise the current requirements for which are jointly regulated by FDA as broad spectrum test a requirement that information that must appear on the sunscreen drugs and by the broad spectrum products meet a UVA I/ principal display panel (PDP) of Environmental Protection Agency (EPA) UV ratio of 0.7 or higher. Given how sunscreen products. The PDP is the part as pesticides under the Federal much of the UVA portion of the of a product label that is most likely to Insecticide, Fungicide and Rodenticide ultraviolet (UV) spectrum is composed be viewed or examined when the Act (FIFRA). In 2007, FDA and EPA of UVA I radiation, and given what we product is displayed for retail sale. A both issued ANPRs requesting comment now know about the skin cancer risks major feature of the PDP is the statement on the appropriate regulatory status of associated with UVA exposure, ensuring of identity (SOI). We are proposing that these products. We are proposing to that sunscreen products provide the SOI consist of an alphabetical listing classify these products as Category II adequate protection in the UVA I of the sunscreen active ingredients in because incompatibilities between FDA portion of the spectrum is critical.3 the product, followed by ‘‘Sunscreen’’ and EPA labeling requirements prevent Because sunscreens with SPF 2 to 14 and the product’s dosage form (such as these products from being labeled in a have not been demonstrated to help lotion or spray). This information would manner that sufficiently ensures safe reduce the risk of skin cancer and early supplement other important elements of and effective use of the sunscreen skin aging caused by the sun, whether the PDP (e.g., SPF, broad spectrum, and component and provides adequate or not they provide protection against water resistance information) to provide directions for use. In addition, there are UVA radiation as well as ultraviolet B a succinct summary of the product’s key data suggesting that combining some (UVB) radiation, we are not proposing to characteristics on the front of the sunscreen active ingredients with the require that they pass the revised broad package or container, permitting insecticide DEET may increase spectrum test. However, we seek consumers to more readily compare absorption of either or both comment on whether these low SPF products and either select or avoid a components. given product accordingly. For products should remain in the market. 7. Proposed Actions To Effectuate Finally, we are proposing to require sunscreen products that have not been Lifting of Stay and Harmonize Impacted that sunscreen products with SPF shown to help prevent skin cancer or Regulations values of 15 or above be labeled with an early skin aging caused by the sun, the SPF number corresponding to the SPF statement would be followed by an Finally, we are proposing to lift the lowest number in a range of tested SPF asterisk (*) directing consumers to see stay on the 1999 Final Monograph results. For example, sunscreens testing the ‘‘Skin Cancer/Skin Aging alert’’ (subject to the revisions to parts 201, at SPF 15–19 would be labeled ‘‘SPF elsewhere on the label. Finally, to 310, 347, and 352 (21 CFR parts 201,4 15’’; those testing at 40–49 would be prevent required information from being 310, 347, and 352) described in this labeled ‘‘SPF 40.’’ We are making this obscured or overwhelmed by other document), and have proposed revisions proposal because new evidence has labeling features, we are revising the to these regulations necessary to caused us to reexamine the variability format requirements for the SPF, broad effectuate the lifting of the stay and to inherent in the SPF test (which relies on spectrum, and water resistance harmonize any impacted regulations. statements on the PDP. visual assessments of erythema in C. Legal Authority human subjects). The data we reviewed 5. Proposed Requirements Related to suggests that the clinical evaluation We are issuing this proposed rule Final Formulation Testing Processes under sections 201, 301, 501, 502, 503, undertaken during SPF testing creates and Recordkeeping variability that justifies the use of SPF 505, 510, 586E, 701, 702, 703, 704, and To ensure that FDA can assess ranges. As explained further in sections 721 of the FD&C Act (21 U.S.C. 321, compliance with our regulations, we are IX.B.4.b–c, because this variability is 331, 351, 352, 353, 355, 360, 360fff–5, proposing to require records of required exacerbated at high SPFs, we are 371, 372, 373, 374, and 379e) and under final formulation testing of sunscreen proposing that sunscreens testing at SPF section 351 of the Public Health Service products to be maintained for 1 year 30 or more be labeled in increments of Act (42 U.S.C. 262). after the product expiration date, or, if 10 (i.e., SPF 30, SPF 40, SPF 50, with D. Costs and Benefits the product is exempt from expiration a proposed maximum of SPF 60+), that dating (as most sunscreens are), for 3 If finalized, the proposed rule would sunscreens testing at SPF 15 to 29 be years after distribution of the last lot update and make effective regulations to ensure the safety and effectiveness of 3 We note that because our proposal to raise the labeled in reliance on that testing. In maximum labeled SPF value to 60+ is based on addition, we are proposing to require sunscreen products marketed under the studies that all used broad spectrum sunscreens, the responsible persons (defined in section OTC drug monograph. The rule would additional clinical benefit we are proposing to IX.D.2.b) to keep records of sunscreen update sunscreen product labeling recognize in sunscreen products with SPF values standards, address the safety of greater than 50 cannot be decoupled from the broad formulation testing, and clarifying that spectrum protection provided by those products. As required records would be subject to sunscreen active ingredients, revise and a result, our proposal to raise the maximum labeled FDA inspection. We are also proposing SPF value to SPF 60+ is both consistent with and a number of revisions to our labeling 4 We note that, for ease of comprehension, we dependent upon our proposal to require that all have included in this document the current sunscreen monograph products with SPF values of and testing regulations designed to provisions of 21 CFR 201.327 that we are not 15 and above satisfy our broad spectrum clarify FDA expectations about clinical proposing to revise along with the provisions of that requirements. final formulation testing processes and regulation that we are proposing to revise.

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clarify our expectations for testing and Abbreviation/ What it means a period of public comment, FDA recordkeeping by entities that conduct acronym publishes a tentative final monograph sunscreen testing, and address other NTP ...... National Toxicology Program of (TFM) (in the form of a proposed rule, sunscreen safety or efficacy concerns, the National Institutes of proposing conditions under which OTC like combination sunscreen-insect Health. drugs in the therapeutic class being repellents and alternative dosage forms. OMB ...... Office of Management and Budg- considered are GRASE and not et. Consumers would benefit from less OTC ...... Over-the-counter. misbranded (see § 330.10(a)(7)). exposure to sunscreen products PABA ...... Aminobenzoic acid. Following public comment on the TFM, containing active ingredients about ROS ...... Reactive oxygen species. FDA publishes a final monograph in which safety questions remain, less SIA ...... Sunscreen Innovation Act. FDA’s regulations (see 21 CFR chapter SPF ...... Sun protection factor. exposure to sunscreen products labeled TEA ...... Time and extent application. I, subchapter D) codifying the with potentially misleading sun TFM ...... Tentative final monograph. conditions under which products in the protection information, increased U.S.C...... United States Code. OTC therapeutic drug category are USP ...... United States Pharmacopeia. consumption of products with better UVA ...... Ultraviolet A. GRASE and not misbranded (see UVA protection, less exposure to UVB ...... Ultraviolet B. § 330.10(a)(9)). An OTC drug may be flammable spray sunscreens, and less legally marketed without an approved exposure to spray and powder III. Background NDA or abbreviated new drug sunscreen products posing inhalation application (ANDA) if it meets each of risks. Consumers would also experience A. FDA’s Current Regulatory Framework the conditions contained in an transaction cost savings. The costs of the In the following sections, we provide applicable final monograph, the rule to sunscreen manufacturers include a brief description of terminology used conditions contained in part 330, and administrative costs, costs to fill data in the OTC Drug Review regulations as any other applicable regulatory and gaps for active ingredients and powder well as an overview of OTC sunscreen statutory requirements for OTC drugs, dosage forms, product formulation products, their intended uses, and including the labeling requirements in testing costs, and costs to reformulate FDA’s regulation of them. part 201. d. Category I, II, and III and relabel sunscreen products. Finally, 1. Terminology testing entities would incur classifications. In the course of recordkeeping costs if they do not a. OTC drug review. The OTC Drug establishing an OTC monograph, active already maintain adequate records of Review is the process established by ingredients and other OTC drug testing equipment, methods, and FDA to evaluate the safety and conditions are classified in one of three observations in final formulation effectiveness of OTC drug products categories: Category I (conditions under testing. marketed in the United States before which a nonprescription drug in the May 11, 1972, and to establish the therapeutic category would be GRASE II. Table of Abbreviations/Commonly conditions under which they are and not misbranded), Category II Used Acronyms in This Document considered to be GRASE and not (conditions that would result in the misbranded. As described further Abbreviation/ drug being classified as not GRASE and/ acronym What it means below, the OTC Drug Review is or misbranded) and Category III generally conducted via a multiphase (conditions proposed to be excluded ANDA ...... Abbreviated new drug applica- public rulemaking process (each phase from the final monograph because tion. ANPR ...... Advance notice of proposed rule- requiring a Federal Register available data are insufficient to classify making. publication), resulting in the them as either Category I or Category II) CFR ...... Code of Federal Regulations. establishment of a monograph for an (see § 330.10(a)(6)). DART ...... Developmental and reproductive OTC therapeutic drug category. toxicity. b. Generally recognized as safe and 2. OTC Sunscreen Products Regulated DEET ...... N,N-Diethyl-meta-toluamide. Under the OTC Drug Review and Their EPA ...... Environmental Protection Agen- effective (GRASE). An OTC drug is cy. ‘‘generally recognized as safe and Intended Uses FAERS ...... FDA’s Adverse Event Reporting effective’’ if it meets each of the OTC sunscreen drugs regulated under System. FDA or Agency .. Food and Drug Administration. conditions contained in an applicable the OTC Drug Review are topically FD&C Act ...... Federal Food, Drug, and Cos- OTC final monograph, the conditions applied products indicated to help metic Act. contained in part 330 (21 CFR part 330), prevent sunburn; some are also FIFRA ...... Federal Insecticide, Fungicide, and any other applicable regulatory and indicated to decrease the risk of skin and Rodenticide Act. FR ...... Federal Register. statutory requirements for OTC drugs, cancer and early skin aging caused by GRASE ...... Generally recognized as safe including the labeling requirements in exposure to the sun’s UV radiation and effective (or general rec- part 201. (when used as directed with other sun ognition of safety and effective- c. Proposed, tentative final, and final protection measures) (see § 201.327(c)). ness). ICH ...... International Council for monographs. The proposed monograph, The active ingredients in sunscreen Harmonisation of Technical which is typically published in the form products achieve these protective effects Requirements for Pharma- of an ANPR, is the end product of the by absorbing, reflecting, and/or ceuticals for Human Use. first phase of the rulemaking process scattering radiation in the UV range IND ...... Investigational new drug applica- tion. described above. After reviewing the (from 290 to 400 nanometers (nm)) (see IRB ...... Institutional Review Board. report and recommendations of an section 586(10) of the FD&C Act (21 mL ...... Milliliter. expert advisory review panel U.S.C. 360fff(10)); see also § 352.3(c) (21 MUsT ...... Maximal usage trial. responsible for initially reviewing the NDA ...... New drug application. CFR 352.3(c)), stayed). NDAC ...... Nonprescription Drugs Advisory safety, effectiveness, and labeling of Sunscreen products must be labeled Committee. products in a given therapeutic with an SPF value calculated using a Ng ...... Nanogram. category, FDA publishes a proposed standardized SPF testing procedure set Nm ...... Nanometer. NOAEL ...... No observed adverse effect level. monograph (together with the report forth in FDA regulations (in NPIC ...... National Pesticide Information and recommendations of the expert § 201.327(i)). As discussed in further Center. review panel) (see § 330.10(a)(6)). After detail in section IX.B.1, the SPF test

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measures the amount of UV radiation sunscreen active ingredients 6 that the TABLE 1—SUNSCREEN ACTIVE INGRE- exposure it takes to cause sunburn when panel recommended for classification as DIENTS INCLUDED IN THE STAYED a person is using a sunscreen when GRASE when used under the conditions 1999 FINAL MONOGRAPH compared with how much UV exposure described in the panel’s report (43 FR it takes to cause sunburn when the 38206 at 38219). In 1993, having Maximum person is not using a sunscreen. Because reviewed the panel’s report and related Active ingredient concentration SPF values represent a sunscreen’s level public comments, FDA published a (%) of sunburn protection, they are TFM (58 FR 28194, May 12, 1993) which (with one exception—padimate Aminobenzoic acid (PABA) .. 15 primarily (though not exclusively) an Avobenzone ...... 3 indicator of expected protection from A) proposed as GRASE all of the active Cinoxate ...... 3 UVB radiation (see section IX.B.1 for a ingredients that had been included in Dioxybenzone ...... 3 discussion of both UVB and UVA the ANPR. The TFM also included Ensulizole ...... 4 radiation). specified maximum concentrations at Homosalate ...... 15 which the proposed ingredients would Meradimate ...... 5 To pass FDA’s current test for the be considered GRASE for use in Octinoxate ...... 7.5 inclusion of the term ‘‘broad spectrum’’ sunscreens. Octisalate ...... 5 in labeling (which was established in In the years following the publication Octocrylene ...... 10 the 2011 L&E Final Rule), sunscreen of the 1993 TFM, FDA removed several Oxybenzone ...... 6 products must demonstrate that, in additional ingredients from the TFM Padimate O ...... 8 addition to UVB protection, they also (see 59 FR 29706, June 8, 1994), as Sulisobenzone ...... 10 provide UVA protection. Further, only Titanium dioxide ...... 25 described at 64 FR 27666 at 27681, and Trolamine salicylate ...... 12 products that have been demonstrated 7 proposed the inclusion of two more. In Zinc oxide ...... 25 both to provide broad spectrum 1999, FDA published a final sunscreen protection and to have a minimum SPF monograph, which included the Among other things, the Stayed 1999 value of 15 have been shown to reduce following 16 sunscreen active Final Monograph established a the risk of skin cancer and early skin ingredients along with the conditions minimum SPF value of 2, and an SPF aging caused by the sun (when used as (including maximum concentrations) of 30+ as the maximum labeled SPF directed with other sun protection under which these ingredients would be value (64 FR 27666). FDA concluded measures). By contrast, sunscreens that considered GRASE for use in that the above-listed ingredients (at the have not been demonstrated to provide 8 sunscreens: listed concentrations) could also be both broad spectrum protection and an used in combination, with limited SPF value of at least 15 have only been 6 The ingredients were: Aminobenzoic acid, exceptions, provided that each active demonstrated to help prevent sunburn.5 digalloyl trioleate, 2-ethylhexyl 2-cyano-3,3- ingredient contributed a minimum SPF Thus, under the 2011 L&E Final Rule, diphenylacrylate, glyceryl aminobenzoate, menthyl anthranilate, padimate O, sulisobenzone, cinoxate, of 2 to the finished product (64 FR passing the broad spectrum test in dioxybenzone, ethylhexyl p-methoxycinnamate, 27666).9 § 201.327(j) (21 CFR 201.327(j)) is homosalate, oxybenzone, 2-phenylbenzimidazole-5- The effective date for complying with necessary, but not itself sufficient, to sulfonic acid, titanium dioxide, diethanoloamine p- methoxycinnamate, ethyl 4-[bis (hydroxylpropyl)] the Stayed 1999 Final Monograph was support inclusion of a skin cancer aminobenzoate, 2-ethylhexyl salicylate, lawsone May 21, 2001. This deadline was indication in labeling, although any with dihydroxyacetone, padimate A, red extended (65 FR 36319, June 8, 2000) product that passes the broad spectrum petrolatum, and triethanolamine salicylate. 7 and then stayed until further notice (66 test may be labeled with the term In 61 FR 48645 (September 16, 1996) (proposing that avobenzone is GRASE up to 3 percent alone FR 67485, December 31, 2001) to ‘‘Broad Spectrum’’ in conjunction with and 2 to 3 percent when in combination with provide additional time to resolve its SPF value. cinoxate, diethanolamine methoxycinnamate, dioxybenzone, homosolate, octocrylene, octyl various outstanding issues, such as the B. History of This Rulemaking methoxycinnamate, octyl salicylate, oxybenzone, labeling and testing of finished OTC sulisobenzone, and/or trolamine salicylate) and 63 sunscreen products. As a result, the 1. The OTC Sunscreen Drug Review and FR 56584 (October 22, 1998) (proposing that zinc FDA’s Regulation of OTC Sunscreen oxide is GRASE alone or in combination with any Drug Products previously proposed GRASE active ingredient ingredients, and the current compendial names are except avobenzone). The list of active ingredients used throughout this document. Because the 2002 was (and would continue to be) modified because final rule that changed those names was published Our initial call for safety and efficacy of, among other things, a lack of interest in after part 352 was stayed, however, those data for sunscreen products was issued developing United States Pharmacopeia (USP) amendments have not yet been incorporated into in 1972 (37 FR 26456, December 12, compendial monographs for certain of the active the published monograph regulation. 1972). The resulting data submissions ingredients originally proposed (see 64 FR 27666 at 9 An exception to this rule involving avobenzone was retained from the TFM: The Stayed 1999 Final were reviewed by the Advisory Review 27681). 8 See § 352.10, now stayed; 64 FR 27666. The Monograph stated that avobenzone may not be Panel on OTC Topical Analgesic, active ingredient names used in that regulation, as combined with PABA, phenylbenzimidazole Antirheumatic, Otic, Burn, and Sunburn originally published, differ from those used in table sulfonic acid, menthyl anthranilate, padimate O, Prevention and Treatment Products, 1, which are the current established names for these titanium dioxide, or zinc oxide. In 2007, we active ingredients. We note that subsequent to the proposed to include in the monograph a condition whose panel report and recommended publication of the Stayed 1999 Final Monograph, permitting the marketing of sunscreens containing monograph were published as an ANPR we issued another final rule in 2002 amending the avobenzone in combination with either zinc oxide in 1978 (43 FR 38206, August 25, 1978). names used for four of those ingredients to make or ensulizole based on safety and effectiveness data The ANPR contained a list of the 21 them consistent with the renaming of those about these combinations provided to the docket ingredients in the corresponding USP monographs (‘‘Sunscreen Drug Products for Over-the-Counter (67 FR 41821 at 41823, June 20, 2002). Under Human Use: Proposed Amendment of Final 5 As described in further detail in section IXB.2, section 502(e) of the FD&C Act, drug labels are Monograph’’, 72 FR 49070 at 49074, August 27, in the time since the L&E Final Rule was issued in required to bear the established name of each active 2007). As described in section VII.A, we now 2011, the body of evidence about the role of UVA ingredient, and if FDA has not designated an anticipate finalizing a monograph that would radiation in the development of skin cancer has official name under section 508 of the FD&C Act (21 permit all listed active ingredients to be combined grown. As a result, FDA is making a number of U.S.C. 358), the compendial name is the established without limitation. This approach is consistent with proposals designed (among other things) to couple name. To comply with section 502(e) of the FD&C the approach to sunscreen combinations generally a greater magnitude of UVA protection to increases Act, sunscreen drug products must therefore bear taken throughout the OTC Drug Review for in SPF values. the current compendial names for their active sunscreens.

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Stayed 1999 Final Monograph has never poses a potential health hazard to the in the FD&C Act (see section 760 (21 been in effect. consumer, FDA generally does not U.S.C. 379aa)), and the provisions of the In 2011, FDA published a draft intend to object to the marketing of OTC FD&C Act addressing adulteration; and guidance for industry, ‘‘Enforcement sunscreen products that do not have an (4) follow applicable labeling and Policy—OTC Sunscreen Drug Products approved NDA or ANDA provided that testing requirements for OTC sunscreens Marketed Without an Approved they: (1) Contain as sunscreen active set forth in § 201.327. Application,’’ addressing the ingredients only the active ingredients 2. Recent Significant Rulemakings circumstances under which FDA or combinations of active ingredients Relevant to This Proposed Rule intended to exercise its enforcement listed in 21 CFR 352.10 and 352.20 discretion with respect to certain (both currently stayed); (2) do not make Since publishing the Stayed 1999 marketed OTC sunscreen products in claims addressed in §§ 201.327(c)(3) and Final Monograph, FDA has issued a the period until a final OTC sunscreen (g) and 310.545(a)(29)(ii); (3) comply number of Federal Register notices monograph becomes effective. This with the requirements for OTC drugs set relating to OTC sunscreens. Major guidance was finalized in May 2018 forth in part 201 and § 330.1 (21 CFR notices pertinent to today’s proposed (2018 Final Guidance) (Ref. 1). Unless 330.1), the requirements for adverse rule are summarized briefly in table 2 the failure to pursue regulatory action event reporting for OTC drugs set forth below: TABLE 2—RECENT SIGNIFICANT Federal Register NOTICES PERTINENT TO THIS RULE

Federal Register notice Information in notice

Insect Repellent-Sunscreen Drug Prod- We issued a notice stating that we were considering amending the Stayed 1999 Final Monograph to include conditions for ucts for Over-the-Counter Human Use: marketing insect repellent-sunscreen drug products and requested information to form a regulatory position on these Request for Information and Com- products. The Environmental Protection Agency, which regulates the insect repellent component of insect repellent-sun- ments; 72 FR 7941, February 22, 2007. screen combinations, published a similar notice concurrently with ours, also seeking information and comment on these products. Sunscreen Drug Products for Over-the- We proposed to amend the Stayed 1999 Final Monograph to address, among other things, formulation, labeling, and test- Counter Human Use: Proposed ing requirements for both UVA and UVB radiation protection. Amendment of Final Monograph; 72 FR 49070, August 27, 2007. Labeling and Effectiveness Testing: Sun- We issued a final rule establishing labeling and testing requirements for sunscreen products. Among other things, the L&E screen Drug Products for Over-the- Final Rule established optional broad spectrum labeling, created an optional indication relating to decreasing the risk of Counter Human Use (L&E Final Rule); skin cancer and early skin aging for broad spectrum products with an SPF of 15 or higher, and required a labeling 76 FR 35620, June 17, 2011. warning for sunscreens that did not both satisfy the broad spectrum test and provide an SPF of at least 15. 2011 Proposed Rule: Revised Effective- We proposed to raise the limit on the maximum permissible labeled SPF value for sunscreen products to ‘‘50+.’’ Among ness Determination (Max SPF PR); 76 other things, we sought comment on the appropriateness of a formulation cap for sunscreen products. FR 35672, June 17, 2011. 2011 ANPR and Request for Data and We issued an ANPR describing the sunscreen dosage forms that we considered to be part of the OTC Drug Review and Information on Certain Dosage Forms; thus eligible for potential inclusion in a sunscreen monograph, as well as those dosage forms that we did not consider 76 FR 35669, June 17, 2011. eligible. We requested data to enable us to ensure that the administrative record would be adequate to support GRASE determinations for the eligible sunscreen dosage forms. In particular, we emphasized that additional safety and efficacy data would be needed to support final monograph status for spray dosage forms. We also announced that we were issuing a draft guidance document (discussed above) explaining the Agency’s intended enforcement policy for sun- screens marketed pursuant to the monograph system, including with respect to dosage forms. The Agency’s approach to enforcement of spray sunscreens is now described in the 2018 Final Guidance.

IV. Scope of This Rulemaking containing active ingredients listed in suggesting that it is necessary to revisit the Stayed 1999 Final Monograph. It its prior decision about the effectiveness Eligibility for inclusion in an OTC does not address the pending sunscreen of the active ingredients at this time. monograph was originally limited to active ingredients that were originally active ingredients and other conditions submitted under the procedures V. Legal Authority that had been used in drugs marketed in established in the TEA regulation and the United States prior to the inception We are issuing this proposed rule are now being addressed through the of the OTC Drug Review in 1972. After under sections 201, 301, 501, 502, 503, SIA process.10 As discussed further in publication of the final sunscreen 505, 510, 586E, 701, 702, 703, 704, and section VII, however, the safety data we monograph in 1999, FDA published its 721 of the FD&C Act and under section described as necessary to evaluate the TEA regulation (§ 330.14), (67 FR 3060 351 of the Public Health Service Act (42 safety and effectiveness of sunscreen at 3074, January 23, 2002), which sets U.S.C. 262). forth criteria and procedures by which products containing those active OTC drugs initially marketed in the ingredients are the same as what we are VI. Need for Additional Safety United States after the OTC Drug now describing as needed to establish Information Review began and OTC drugs without that the active ingredients listed in the Stayed 1999 Final Monograph are A. Increased Consumer Exposure to any U.S. marketing experience can be Sunscreen Active Ingredients considered for inclusion in the OTC GRASE for use in sunscreen products. drug monograph system. Congress later We are not revisiting the contribution Consumer exposure to sunscreen passed the SIA, which, among other that the active ingredients listed in the active ingredients has increased Stayed 1999 Final Monograph make to things, supplements FDA’s TEA dramatically since FDA began its initial the effectiveness of sunscreens. The regulations for OTC sunscreen drug safety evaluations of the sunscreen Agency has not received information products (21 U.S.C. 360fff through active ingredients at issue in this 360fff–7) (2014). proposed rule. Many factors have 10 FDA’s proposed sunscreen orders on each of This proposed rule addresses the these ingredients can be found at https:// influenced this increase, including the GRASE status (and conditions of use www.fda.gov/drugs/guidancecompliance following: applicable to) sunscreen drug products regulatoryinformation/ucm434843.htm.

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• Significant increases in the number more active ingredients combined general recognition of safety and and types of consumers using together in higher concentrations than effectiveness as set forth in § 330.10. sunscreen products (Refs. 2 and 3) were generally combined in products VII. Framework for Evaluation of • Sunscreen products containing a when FDA’s review of OTC sunscreens Safety Data greater number of active ingredients at began. Increased knowledge about the greater concentrations (Ref. 4) role of UVA radiation in causing skin In light of these safety concerns, FDA • Increased awareness of the risks of damage has also encouraged the held a meeting of its Nonprescription sun exposure and encouragement of formulation of broad spectrum products Drugs Advisory Committee (NDAC) on routine sunscreen use by medical and with combinations of active ingredients September 4 and 5, 2014, to discuss the public health authorities (see, e.g., designed to achieve protection against scope of safety testing that should be Ref. 5) both UVA and UVB radiation. In conducted to support general • Evolving directions for use on addition, other widely used products, recognition of safety and effectiveness sunscreen products instructing such as facial makeup, moisturizing for active ingredients for use in consumers to use greater amounts of creams, and lipsticks, have had nonprescription sunscreen products. sunscreen per application and to sunscreen active ingredients added to FDA proposed the following safety reapply sunscreen products more their formulations. These trends are testing paradigm: frequently (76 FR 35672 at 35678), reflected in the evolution of the current Clinical data: codified as § 201.327) labeling provisions for sunscreen • Dermal irritation and sensitization • Expanding availability and use of products regulated under the OTC testing many different types of sunscreen monograph system. • Phototoxicity and products, including daily-use Changes in the instructions for using photoallergenicity testing products such as facial makeup, these sunscreen products have also • Human maximal use bioavailability moisturizing creams, and lipstick contributed to increased use of, and studies Relatively few sunscreen products exposure to, sunscreen active • Postmarketing adverse event reports were in use when the U.S. Army ingredients. The labeling recommended Nonclinical (toxicology) data: initially funded research into the by the advisory panel in 1978 simply • Dermal carcinogenicity development of effective sunscreen instructed consumers to apply • Systemic carcinogenicity products for use by military personnel sunscreen products liberally and to • Developmental and reproductive on aircraft carriers (and others routinely reapply after swimming or excess toxicity (DART) exposed to long periods of intense perspiration (43 FR 38206 at 38215). • Toxicokinetics sunlight) during World War II (Ref. 2). The labeling currently required, by • Additional testing when data The reach of sunscreen products began contrast, encourages consumers to suggest a concern about other long- to broaden when they were later always use a broad spectrum SPF 15 or term effects, such as endocrine marketed for use specifically by higher product, to use sunscreen effects consumers who sunburned readily (i.e., products regularly, and to apply them There was consensus among the fair-skinned individuals) in situations of generously/liberally 15 minutes before committee members that FDA’s intentional sun exposure, such as sun exposure and at least every 2 hours proposed framework was a good starting sunbathing on a beach (Ref. 6). or more frequently when swimming or point (Ref. 10). In November 2015, FDA Sunscreen products are now routinely sweating (§ 201.327(e)). published a draft guidance for industry, used by a much broader range of B. Emerging Safety Concerns ‘‘Over-the-Counter Sunscreens: Safety consumers for protection against many and Effectiveness Data’’ (Draft Safety types of sun-induced skin damage, not In recent years, a growing body of and Effectiveness Data Guidance) (see just sunburn. Accumulating data data has suggested that the transdermal 80 FR 72975, November 23, 2015), demonstrate that increased sun absorption of some sunscreen active which described and requested exposure increases the risk of ingredients is greater than previously comment on the safety and effectiveness developing skin cancers and premature thought, and thus may raise previously data necessary to determine whether an skin aging (Ref. 2). To help reduce the unevaluated safety concerns, including OTC sunscreen active ingredient or risk of these types of sun-induced skin the potential for reproductive, combination of active ingredients damage, public health organizations developmental, or carcinogenic effects. evaluated under the SIA was GRASE (including FDA) have for years urged As discussed in further detail in section when used under specified conditions. consumers to use sunscreen products VIII.C.1.a, newly available information FDA finalized this guidance in along with other sun-protective suggests, for example, that there is the November 2016, after considering behaviors like limiting time in the sun potential for toxicity associated with the public comment on its draft and wearing protective clothing (Refs. 7, transdermal absorption and systemic recommendations (Ref. 11).11 The 8, and 9). availability of oxybenzone. This new recommendations in this guidance Another factor driving increased information about absorption and reflect FDA’s scientific expertise, consumer exposure to sunscreen active potential safety risks is inadequate, by existing technical guidance, experience ingredients has been the introduction itself, to support an affirmative from reviewing safety and efficacy data and widespread adoption of sunscreen conclusion that products containing the submitted for GRASE review of products with higher labeled SPF active ingredients at issue are not safe. sunscreen active ingredients under the values. The maximum SPF value Coupled with the lack of clinical OTC Drug Review, and input from and proposed for sunscreen labeling has pharmacology and nonclinical safety progressively increased from SPF 15 in data for certain sunscreen active 11 FDA’s recommendations regarding the safety the 1978 panel report, to SPF 30+ in the ingredients, however, it leads us to and effectiveness data necessary to determine Stayed 1999 Final Monograph, to SPF conclude that, for some sunscreen active whether an OTC sunscreen active ingredient (or ingredients, the current record does not combination of ingredients) evaluated under the 50+ in the 2011 Max SPF PR. To achieve SIA was GRASE when used under specified these higher SPFs, many currently include adequate evidence of safety to conditions generally remained unchanged in the marketed products are formulated with satisfy the applicable legal standards for final guidance.

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concurrence by outside scientific important for FDA to balance the toxicity). Additional testing beyond experts. potential benefits of these sunscreen what is described below may be All sunscreens marketed without an products to consumers against their recommended for active ingredients for NDA are subject to the same standard: potential risks. Providing an adequate which data suggest a concern about General recognition of safety and safety margin for OTC sunscreen active other long-term effects, such as effectiveness. Accordingly, as noted ingredients and finished sunscreen hormonal disruption. previously, the data that we expect to be products is a key element of FDA’s risk In addition, although sunscreen necessary to evaluate the safety and assessment. A safety margin calculation products are typically formulated with effectiveness of the sunscreen takes the highest animal NOAEL and two or more active ingredients, the monograph active ingredients are the estimates a maximum safe level of framework described below same as those we recommended as exposure for humans. Because animal contemplates that testing will be necessary to evaluate the safety and studies do not always predict effects in performed using formulations that effectiveness of sunscreen active humans, the actual threshold for an include one active ingredient. ingredients previously considered under effect in humans may be different (i.e., Generally, unless data suggest that there the procedures established in the TEA higher or lower) than in the species may be a safety or efficacy concern with regulation and now being considered tested. The human sensitivity to a drug a particular combination of active pursuant to the framework established is often unknown. To account for this, ingredients, we anticipate that an active by the SIA (see Safety and Effectiveness the predicted safe exposure level in ingredient that is found to be GRASE for Data Guidance (Ref. 11)). humans that is reflected in the safety use in sunscreens could be combined The studies described in this section margin is well below where toxicities with other active ingredients that are are generally needed for FDA to were seen in animals. also GRASE for use in sunscreens. If determine that a sunscreen active In determining the specific testing data suggest that there may be a safety ingredient is GRASE for use in and other data needed to adequately or efficacy concern with a particular nonprescription sunscreens. Specific demonstrate that an OTC sunscreen combination of active ingredients (or data gaps for individual active active ingredient is safe, FDA considers active and inactive ingredients), ingredients depend on the quality and both the circumstances under which additional data may be necessary to quantity of available safety data, and are OTC sunscreen products are intended to support a positive GRASE identified in section VIII. As described be used by consumers (i.e., the determination for sunscreens containing in that section, those active ingredients conditions of use) and current scientific that combination. for which the existing public record knowledge and assessment technology. The following sections describe the contains sufficient data to support a FDA’s approach to the clinical safety specific safety data that FDA expects the positive GRASE finding are proposed as evaluation of OTC sunscreen active Agency will need to determine whether Category I. Those for which additional ingredients is based on our current an active ingredient is GRASE for use in data are necessary are proposed as scientific understanding regarding sunscreens. Category III. In addition, in evaluating safety evaluation of topical drug the existing safety data for the active products for chronic use, and thus is B. Clinical Safety Testing ingredients listed in the Stayed 1999 generally consistent with the safety data 1. Human Dermal Safety Studies Final Monograph, FDA determined that requirements that would apply to an Human dermal safety studies for the risks associated with two of these NDA for a chronic-use topical drug topical products in which exposure to ingredients outweigh their benefits. As product (i.e., topical safety studies light after application is anticipated discussed in further detail in section (irritation, sensitization, and generally consist of two sets of studies— VIII.B, FDA is therefore proposing that photosafety); bioavailability those conducted without specific these two ingredients are Category II (absorption); and evaluation of adverse exposure to light and those conducted because sunscreens containing these events observed in clinical studies).12 In to assess reactions after UV exposure ingredients would not be GRASE. addition, the evaluation of adverse (photosafety studies) (Ref. 12). The events reported during the commercial A. General studies usually consist of dermal marketing of sunscreen products FDA’s OTC drug regulations identify irritation patch testing, dermal containing the ingredient and other the general types of safety information sensitization patch testing, dermal postmarketing safety information is also that should be submitted as evidence phototoxicity testing, and dermal relevant to safety. that an OTC drug is GRASE for use as FDA’s approach to the nonclinical photoallergenicity testing. Because marketed sunscreen products labeled (§ 330.10(a)(2)) and the standard safety evaluation of these active typically contain a combination of by which safety is to be judged ingredients takes into account their active ingredients, and product (§ 330.10(a)(4)(i)). When applying these lengthy marketing history in the United formulations frequently change, it is regulations to each drug, FDA uses its States. In contrast to nonclinical data difficult to determine causal links scientific expertise to determine what requirements for a chronic-use topical between individual active ingredients constitutes ‘‘adequate tests by methods drug product NDA, which include and reported irritation and reasonably applicable to show the drug results from comprehensive nonclinical hypersensitivity adverse events is safe under the prescribed, pharmacology and toxicology safety associated with a particular product. recommended, or suggested conditions testing, the approach to nonclinical Therefore, FDA generally expects to use of use’’ (§ 330.10(a)(4)(i)). safety testing in this proposed rule is FDA recognizes the contribution that data from human dermal irritation largely focused on potential long-term broad spectrum sunscreens with an SPF studies, human dermal sensitization adverse effects or effects not otherwise value of 15 or higher can make to studies, and human dermal photosafety readily detected from human use (i.e., decreasing the risk of skin cancer and studies, in conjunction with carcinogenicity and reproductive early skin aging caused by the sun if postmarketing adverse event data, to used as directed with other sun 12 Chronic use is defined as continuous or inform GRASE determinations and protection measures. To protect the intermittent use for at least 6 months during the labeling. Nonetheless, in some cases, it public health, however, it is also course of a lifetime. may be reasonable to omit human

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dermal irritation studies, human dermal sufficient number of subjects are enhancement by solvent effects on the sensitization studies, and/or human included for sensitization evaluation. lipids in the stratum corneum. Products dermal photosafety studies, depending b. Human photosafety studies. absorbed through the skin have the on the rigor of available postmarketing Topically applied dermatologic drug potential to cause systemic adverse safety information. For example, if FDA products should be tested for effects, affecting the safety assessment. concludes that there is a positive risk- photosafety if they absorb light in the Because sunscreens are intended to benefit profile for a sunscreen active UVA, UVB, or visible spectra. work at the skin’s surface, systemic ingredient, but that it is known to be a Photosafety evaluations of sunscreen absorption may also lower efficacy, sensitizer, it may be possible to develop active ingredients that absorb light affecting the efficacy assessment. Such safety labeling to address this risk should consist of skin considerations ultimately weigh into the without data generated in the human photoallergenicity and skin risk-benefit calculus FDA uses to dermal safety studies described below phototoxicity testing. Photoallergy is an determine whether an OTC sunscreen (see, e.g., section VIII.C.1.a). immunologically mediated reaction to a containing a given active ingredient is a. Human dermal irritation and chemical, initiated by the formation of GRASE. sensitization studies. Studies of dermal photoproducts (e.g., protein adducts) Since the mid-1990s, topical product irritation and sensitization, using the following a photochemical reaction. NDAs have included a Maximal Usage repeat insult patch test or other relevant Similar to dermal sensitivity testing Trial (MUsT) as part of the clinical tests, are elements in the safety described above, photoallergy tests use pharmacology/bioavailability evaluation of topical drug products that, an induction/rest/challenge/rechallenge assessment. A MUsT is designed to like sunscreens, are applied to the skin multiphase design to assess erythema, capture the effect of maximal use on repeatedly over long periods of time. edema, and vesiculation. Phototoxicity absorption into the blood with standard Designed to detect the potential for local (or photoirritation) is an acute light- pharmacokinetic assessments (e.g., Cmax, 13 dermatologic events with fewer subjects induced tissue response to a Tmax, area under the curve, half-life, than might be observed in larger clinical photoreactive chemical. Phototoxicity clearance, and volume of distribution) trials, these tests often employ product testing typically includes a test patch, a (for further information about conduct application that is more frequent and/or vehicle patch, and a sham patch of a MUsT, see Ref. 13). For a topical for longer duration than proposed application for 24 hours, followed by product NDA, the MUsT is usually clinical dosing. In dermal irritation UV light exposure of the test area. A conducted in subjects with the disease studies, a test substance is applied to a second set of patch application areas not of interest, where disrupted skin is a small pad (patch) and affixed to the test irradiated with light serves as a control. feature. In situations where disrupted subject’s skin, usually on the back, to FDA expects that, to support a GRASE skin is not a feature of the condition determine whether the ingredient finding, photosafety studies of being treated or the topical product is causes direct skin toxicity. Dermal sunscreen active ingredients that absorb intended for prevention of disease (e.g., sensitization studies are conducted light will need to be conducted using sunscreens), the MUsT for a topical similarly but are designed to detect the active ingredient at the highest product NDA should be conducted in immunologically mediated reactions, concentration for which a GRASE subjects with healthy, intact skin. The which require prior exposure to the determination is sought in an MUsT for a topical product NDA is allergen. appropriate vehicle, using the vehicle conducted with the specific product Nonprescription sunscreens regulated alone, and with a negative control. formulation for which approval is under the OTC monograph system may sought applied at the upper limit of be used in many product formulations, 2. Human Absorption Studies/Maximal Usage Trial surface area involvement that is studied including those yet unknown. in the phase 3 clinical trials and is Therefore, cumulative irritation studies Because nonprescription sunscreens proposed for labeling. For example, if that evaluate the sunscreen active are topically applied, a critical safety the proposed labeling of an acne ingredient at the highest concentration consideration is whether dermal product permits the product to be used for which a GRASE determination is application results in skin penetration on up to 30 percent of body surface area, sought should be conducted using the and systemic exposure to their active that would be the coverage evaluated in ingredient in an appropriate vehicle, ingredients and, if so, to what extent. the MUsT. using the vehicle alone, and using both This information helps identify We expect that data from a MUsT will negative and positive controls. The potential safety concerns and helps be needed to support an adequate evaluation should include scoring of determine whether an adequate safety assessment of safety for most sunscreen erythema, edema, and a papular margin exists within which an active active ingredients (Ref. 10). Because response or skin erosion. ingredient is GRASE for use in sunscreen products regulated pursuant Dermal sensitization studies, sunscreens. to the OTC monograph system may conducted to detect immunologically The principal barrier to topical drug include active ingredients in a variety of mediated reactions, should be product penetration is the multilayered, formulations, FDA recommends that a conducted in three phases: (1) The lipid-rich stratum corneum. The passage MUsT be conducted under maximal use induction phase (3 weekly applications of any drug product through this layer conditions employing a minimum of for 3 weeks); (2) the rest phase (no is influenced by many factors, including four formulations, containing the product application for 10 to 14 days); the drug product’s physicochemical sunscreen active ingredient as the only and (3) the challenge phase (patch features, molecular weight, and vehicle/ active ingredient.14 These formulations applications to new sites for 48 hours formulation properties. Vehicle/

formulation properties are particularly 13 with a confirmatory rechallenge to Cmax is the peak plasma concentration and Tmax exclude false positives). important because the choice of vehicle is the time to peak plasma concentration. Although FDA recommends separate can markedly affect the permeation 14 We note, however, as described in section dermal irritation and sensitization potential of a drug product. Effects can VIII.C.1.b, that because of avobenzone’s potential for photodegradation, we recommend that a MUsT studies, it may be appropriate to range from simple hydration of the for avobenzone evaluate avobenzone in combine irritation and sensitization stratum corneum by occlusive vehicles/ combination with a photostabilizer. In some cases, studies in the same study as long as a formulations to direct permeation Continued

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should be prepared using vehicle/ penetration of the ingredient has taken within an acceptable range for this formulation systems that are appropriate place and to optimize the chances of the population. for sunscreen topical products (e.g., they ingredient being detected. Thus, for C. Nonclinical Safety Testing are deployable and spreadable) that sunscreen active ingredients, FDA represent real-world marketed expects that single application studies 1. Carcinogenicity Studies: Dermal and formulations, and that are expected to would be inadequate. Because the Systemic produce the highest in vivo absorption. subjects in a MUsT represent an FDA generally recommends Justification for the formulations enriched dataset in the upper range of carcinogenicity studies for any chosen, including results of in vitro exposures, safety-related data (such as pharmaceutical with an expected testing using a human cadaver skin vital signs, adverse events) from the clinical use (either intermittent or permeation system (e.g., static cell, also study’s regularly scheduled physical continuous) of at least 6 months (Ref. known as vertical diffusion cell) (Refs. examinations should also be collected. 17). The animal carcinogenicity studies 14 and 15), should be included in the We strongly encourage consultation help characterize the potential tumor study protocol. The protocol should with FDA about MUsT protocols before risks associated with use of a sunscreen contain sufficient detail for others to beginning the trial. active ingredient in human beings by Finally, as discussed further in reproduce the formulations and identifying any observed tumors by 15 section VIII.D, if the sunscreen active manufacturing process. type, the level of exposure at which FDA anticipates that the use of ingredient is determined to be GRASE tumors occur, and the highest level of multiple formulations will help identify for use in sunscreens, the sunscreen exposure at which no adverse effects the overall absorption potential of the monograph, when finalized, must set occur, referred to as the NOAEL. As sunscreen active ingredient of interest. out the conditions under which any The MUsT should be conducted in future sunscreen containing that active noted earlier, FDA intends to use the subjects with healthy, intact skin 16 at ingredient will be GRASE and not NOAEL in determining the safety the highest concentration of the misbranded. As such a condition, FDA margin for human exposure to ingredient for which a GRASE is considering certain final formulation sunscreens containing the active determination is sought. Based on testing to address the potential for ingredient. In addition to detecting recommended sunscreen use on all transdermal absorption and its impact carcinogenic potential, carcinogenicity exposed skin, the exposed area should on safety. FDA anticipates that the studies in animals can also help to include at least 75 percent of the body formulation that produces the highest in identify other systemic or organ surface area. Data from the formulation vivo absorption in the MUsT would be toxicities that may be associated with that produces the highest in vivo appropriate to designate as a standard the sunscreen active ingredient. absorption would then be used to control formulation for future in vitro FDA expects that a dermal determine the safety margin. human cadaver skin permeation system carcinogenicity study involving The assay used in the MUsT should testing (e.g., a static or vertical diffusion application of the test article to the skin be properly validated according to cell) of each final sunscreen formulation of mice or rats for 2 years will thus need current good laboratory practices (21 that includes that active ingredient. If to be conducted to support a GRASE CFR part 58). Additionally, the Agency’s such testing were included as a finding for the active ingredient unless most current guidance on bioanalytical condition in a final sunscreen the ingredient has been demonstrated method validation may be found by monograph, and if in vitro permeation not to reach the viable layers of the skin searching at https://www.fda.gov/ of the sunscreen active ingredient in the where it could impact skin tumor RegulatoryInformation/Guidances/ final product formulation were equal to development. FDA also considers it default.htm. The assay’s limit of or less than the value from in vitro important to study the effects of quantitation-limit of detection should be testing of the standard control systemic exposure if human sufficiently low to allow a signal-to- formulation (that was shown by the bioavailability data show that dermal noise ratio that ensures confidence in MUsT to have the highest degree of application of a particular formulation detection of a concentration of 0.5 systemic absorption), FDA anticipates results in skin penetration and systemic nanogram (ng)/milliliter (mL) for the that the safety margin previously exposure to the active ingredient. compound of interest in the receptor calculated would be considered Therefore, we expect that a second fluid. adequate to support the safety of the carcinogenicity study by a route that An important consideration for finished formulation. produces systemic exposure will also be designing a MUsT is that it should needed to support the safety of a include testing for a duration that 3. Pediatric Considerations sunscreen active ingredient, if systemic allows for the attainment of steady state Young children have a larger ratio of exposure is observed in the levels to ensure that maximum skin surface to body volume than adults, bioavailability data. This can be a 2-year which can increase a child’s systemic study or a shorter (usually 6 months) sunscreen active ingredients (e.g., octocrylene) can exposure to topically applied drug alternative carcinogenicity model, and it serve as photostabilizers. In such cases, we expect products. In addition, growing children should be conducted in a species that the MUsT could include such ingredients. have greater potential to experience different from that used in the dermal 15 FDA has issued draft guidance with recommendations for the conduct of MUsT studies deleterious developmental effects from carcinogenicity study. FDA notes that to support the safety of active ingredients that are drug exposure. If the calculated safety the absence of a carcinogenicity signal candidates for inclusion in a topical drug product margin for an active ingredient (based from an alternative transgenic under an OTC Drug monograph (Ref. 16). When on nonclinical results and human carcinogenicity study (e.g., TgRasH2 finalized, this guidance will represent FDA’s current thinking on this topic. FDA also encourages MUsT) is relatively small, FDA will mouse) would likely support the safety persons who are interested in conducting a MUsT exercise its scientific judgment to of a sunscreen active ingredient. If a to support the safety of an active ingredient to determine whether a sunscreen active carcinogenicity signal were observed in discuss proposed protocols with the Agency. ingredient MUsT in young children or such a study, however, the study could 16 As discussed infra, the MUsT should be conducted on healthy, intact skin because other studies are warranted to ensure not be used to support the safety of a sunscreens are intended for prevention rather than that the safety margin for marketed sunscreen active ingredient because treatment. products containing the ingredient is there would be no basis for calculating

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a safety margin with this study (Ref. 18). conducted toxicology program produces applications in a wide range of All carcinogenicity studies, regardless of no signals indicating that the ingredient products, including OTC sunscreens. route, should assess a full panel of (including its clinically relevant Such materials generally have tissues.17 metabolites) or any known structurally dimensions between approximately 1 FDA expects that a systemic similar compound interacts with related and 100 nm (Ref. 23). Materials at such carcinogenicity study would not be pathways.18 We expect that effects on small sizes can have different chemical needed to support a GRASE embryofetal development will need to or physical properties or biological determination for a sunscreen active be assessed in rats and rabbits in all effects compared to larger-scale ingredient if an adequately conducted cases. counterparts, making possible a variety human pharmacokinetic MUsT resulted Gestational and neonatal stages of of functional effects, and also in a steady state blood level less than development may be particularly potentially affecting the safety, 0.5 ng/mL, and an adequately sensitive to active ingredients with effectiveness, or regulatory status of conducted toxicology program did not hormonal activity (endocrine FDA-regulated products. reveal any other safety signals for the disruption). For this reason, these FDA has not established regulatory ingredient or any known structurally studies should include assessments of definitions of nanotechnology, similar compound indicating the endpoints such as vaginal patency, nanomaterial, nanoscale, or other potential for adverse effects at lower preputial separation, anogenital related terms. As described in FDA’s levels. The threshold value of 0.5 ng/mL distance, and nipple retention, which guidance for industry ‘‘Considering is based on the assessment that the level can be incorporated into traditional Whether an FDA-Regulated Product would approximate the highest plasma DART study designs to assess potential Involves the Application of level below which the carcinogenic risk hormonal effects on the developing Nanotechnology’’ (Nanotechnology of any unknown compound would be offspring. Behavioral assessments (e.g., Considerations Guidance) (Ref. 24), at less than 1 in 100,000 after a single mating behavior) of offspring, which this time, when considering whether an dose. This threshold value is consistent may detect neuroendocrine effects, FDA-regulated product involves the with the Threshold of Toxicological should also be performed (Ref. 21). application of nanotechnology, FDA Concern concept, which was applied to asks impurities in the ICH guidance for 3. Toxicokinetics (Ref. 22) (1) Whether a material or end product industry ‘‘M7 Assessment and Control Animal toxicokinetic data should also is engineered to have at least one of DNA Reactive (Mutagenic) Impurities be collected for sunscreen active external dimension, or an internal or in Pharmaceuticals to Limit Potential ingredients, as these data provide an surface structure, in the nanoscale range Carcinogenic Risk’’ (Ref. 19). FDA important bridge between toxic levels (approximately 1 nm to 100 nm). expects that the 0.5 ng/mL seen in animal studies and any potential In addition, because materials or end concentration will be sufficiently above human adverse events associated with products can also exhibit related the assay’s limit of quantitation—limit systemic exposure to the sunscreen’s properties or phenomena attributable to a dimension(s) outside the nanoscale of detection to allow a signal-to-noise active ingredient. Toxicokinetic range of approximately 1 nm to 100 nm ratio that ensures confidence in either measurements are usually obtained that are relevant to evaluations of safety, the derived concentrations (in the case during the course of ongoing nonclinical effectiveness, performance, quality, of ‘‘exaggerated’’ values) or lack of toxicity studies, such as carcinogenicity public health impact, or regulatory concentrations. or DART studies, rather than through status of products, we will also ask: separate studies. 2. Developmental and Reproductive (2) Whether a material or end-product Toxicity Studies D. Postmarketing Safety Data is engineered to exhibit properties or FDA expects that DART studies will In addition to the active ingredient phenomena, including physical or need to be conducted to evaluate the safety data already described, FDA’s chemical properties or biological effects, potential effects that exposure to the GRASE evaluation also takes into that are attributable to its dimension(s), sunscreen active ingredient may have consideration publicly available even if these dimensions fall outside the on developing offspring throughout information about serious adverse drug nanoscale range, up to 1 micrometer gestation and postnatally until sexual m experiences and known or expected ( m) (1,000 nm). maturation, as well as on the We will apply these considerations adverse effects associated with reproductive competence of sexually broadly to all FDA-regulated products, commercially marketed products that mature male and female animals (Ref. including sunscreen products. For the contain the active ingredient(s) under 20). As with systemic carcinogenicity purpose of this proposed rule, we use consideration. studies, we expect that studies to assess the term ‘‘nanomaterial’’ generally to fertility and early embryonic E. Sunscreens Containing refer to materials falling within either development, and pre- or postnatal Nanomaterials point 1 or 2 above. The use of this term toxicity in rats will not be needed if an We note that FDA is not proposing to in this manner is consistent with its use adequately conducted human MUsT categorically classify sunscreen in FDA’s nanotechnology-related shows a steady state blood level less products manufactured using guidances, including FDA’s than 0.5 ng/mL, and an adequately nanotechnology (or containing Nanotechnology Considerations nanomaterials) as GRASE or not GRASE Guidance. 17 FDA recommends submitting the Nanomaterial forms of the active solely based on this characteristic. carcinogenicity study protocol(s) for review by ingredients zinc oxide and titanium Nanotechnology is used to create, FDA’s Center for Drug Evaluation and Research’s dioxide have been used in marketed (CDER’s) Executive Carcinogenicity Assessment explore, or manipulate materials OTC sunscreens. In addition to Committee before initiating the studies. For further measured in nanometers (nm) guidance regarding carcinogenicity studies, see the nanomaterial forms of zinc oxide and (billionths of a meter), and has FDA guidance for industry ‘‘Carcinogenicity Study titanium dioxide, other nanomaterials Protocol Submissions,’’ May 2002 (available at https://www.fda.gov/ucm/groups/fdagov-public/ 18 Examples of such pathways could include are also reported to have been used, or @fdagov-drugs-gen/documents/document/ endocrine function and signaling pathways related promoted or studied for possible use, in ucm078924.pdf). to growth and development. sunscreen products (Ref. 25).

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As discussed in further detail in outweigh their benefits, the ingredients penetration—regardless of particle section VIII.A, having examined the are proposed as Category II. size—is primarily limited to the upper scientific information in the record, layers of the non-living stratum A. Ingredients Proposed as Category I including for nanomaterial forms of zinc corneum, with most penetration oxide and titanium dioxide, FDA is not Based on our review of the publicly occurring only into skin folds and now proposing conditions of use for available data for these ingredients, both furrows or hair follicles. These studies these two active ingredients under the zinc oxide and titanium dioxide are show that zinc oxide particles do not sunscreen monograph that distinguish proposed as Category I. penetrate down into the viable dermis to nanomaterials from other forms of these 1. Zinc Oxide any significant extent. Any de minimis ingredients. As indicated above, FDA transdermal penetration that may occur also does not propose to categorically Our review of the scientific literature, does not result in adverse health effects, submissions to the sunscreen classify sunscreen products that are because the tiny amount of zinc oxide monograph docket, and adverse event manufactured using nanotechnology or particles that achieve transdermal reports submitted to FAERS has contain nanomaterials as GRASE or not, absorption, if any, would dissociate into produced sufficient safety data on zinc solely on that basis. Manufacturers of zinc and oxygen ions, both of which are oxide to support a proposal that a products containing nanomaterials naturally occurring elements in the sunscreen containing up to 25 percent marketed under the OTC sunscreen human body (Ref. 30). Zinc is the 14th zinc oxide would be GRASE under the monograph remain responsible for most common element in the human conditions proposed in this rulemaking ensuring that the product satisfies all body and is essential for all living and the general conditions required in applicable legal requirements. FDA things; the average human body part 330. This proposal is based in encourages manufacturers of such contains about 2.0 to 2.5 grams of zinc, products to consult with FDA to significant part on the existing, substantial evidence that zinc oxide and normal dietary intake of zinc is facilitate a mutual understanding of about 15 milligram (mg) per day (Refs. specific scientific or regulatory issues (including particles on the nanoscale, i.e., approximately 1 to 100 nm) does 30 and 31). Homeostatic mechanisms in relevant to their product. the body regulate zinc’s absorption, FDA invites comment on the not penetrate into or through human skin to any great extent and, to the distribution, cellular uptake, and following topics: excretion (Ref. 31). Similarly, any • Specific nanomaterials or types of extent any de minimis penetration occurs, does not result in adverse health oxygen absorbed through the skin is nanomaterials that have been used or nonharmful, as oxygen is plentiful in proposed for use in OTC sunscreen effects, given the high levels of endogenous zinc in the human system. the human body and essential for life. products Our search of the literature on zinc • Concerns about sunscreen product a. Background. Zinc oxide is an oxide revealed four recent studies about safety, effectiveness, or quality inorganic, mineral compound. Because zinc oxide’s penetration into human associated with the use of of its ability to reflect UVA wavelengths, skin, which confirm our expectations nanomaterials in OTC sunscreen zinc oxide is frequently used in products, with supporting data sunscreens to help establish broad based on the physical properties of this • Need for, and proposals of, spectrum protection (Ref. 26). While compound. The first two studies specifications or limitations for larger particles of zinc oxide used in (conducted by Leite-Silva et al. and particular nanomaterials for use in sunscreens (greater than approximately Darvin et al.) examined the penetration OTC sunscreen products 100 nm) may impart an opaque, white of zinc oxide into the skin using • Any particular nanomaterials that you color to the product, zinc oxide is also multiphoton tomography (Refs. 32 and believe should not be permitted for manufactured in smaller particle sizes 33). Both studies showed a lack of use in OTC sunscreen products, along (less than approximately 100 nm) to overall permeation of zinc oxide beyond with supporting scientific information reduce this white/opaque appearance a few cell layers, except in the case of • FDA’s proposed regulatory approach (Refs. 27 and 28). In addition to its use furrows and wrinkles (Refs. 32 and 33). and/or alternative regulatory in sunscreens, zinc oxide is also used in The second two studies—a pilot and approaches to the use of non-sunscreen ointments, pastes, and subsequent full trial conducted by nanomaterials in OTC sunscreen lotions for various skin disorders Gulson et al.—evaluated the penetration products because of its protective, astringent, and of nanoscale zinc oxide into the skin antiseptic properties (Ref. 29). and the bloodstream using a stable VIII. Existing Safety Data for Sunscreen b. Discussion. Zinc oxide is insoluble isotope tracing method (Refs. 34 and Active Ingredients in water and largely insoluble in 35). Although the Gulson studies found In the remainder of this section, we biological fluids.19 This insolubility that a minimal amount of topically discuss the existing data and data gaps precludes the possibility of its systemic applied zinc was absorbed, the for each of the sunscreen monograph absorption from topical application of absorption observed was at levels that active ingredients and explain why we sunscreen products beyond a de are orders of magnitude less than daily propose that these active ingredients are minimis amount, even if zinc oxide is nutritional intake and well below what GRASE or not GRASE for use in included at its maximum eligible would be of concern for a naturally sunscreens. Those ingredients for which concentration of 25 percent and occurring element in the body subject to the existing data are sufficient to regardless of the formulation of the homeostatic mechanisms (Ref. 36). An support a positive GRASE product. The available studies on the additional porcine study found (as determination are proposed as Category dermal penetration of zinc oxide, discussed in our 2012 response to a I. Those ingredients for which further discussed below, confirm that its citizen petition submitted by the additional data are necessary before a International Center for Technology GRASE determination can be made are 19 We note that nanoscale zinc oxide can be Assessment and others (Docket No. proposed as Category III. In cases where solubilized to a small extent in the presence of FDA–2006–P–0213–0003) (ICTA phosphate and lecithin at pH’s that are achievable FDA’s evaluation of the existing safety on the skin. Even under these conditions, however, Petition Response)), that although data caused us to determine that the the amount potentially absorbed is de minimis and sunburn caused by UVB rays increased risks associated with the ingredients far lower than daily nutritional intake of zinc. the penetration of zinc oxide into the

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non-living stratum corneum, there more active ingredients, making it c. Conclusion. Our review of the remained minimal penetration of zinc difficult to attribute causation to a available data from both animal and oxide into the epidermal and dermal specific active ingredient. Unlike other human studies and data on physical layers of the skin (Ref. 37). Because sunscreen ingredients with a known properties such as solubility leads us to topically applied zinc oxide particles do hypersensitivity risk, we did not conclude that the transdermal not enter systemic circulation to any identify any reports in FAERS or in the absorption of zinc oxide—regardless of meaningful extent, we do not consider literature with features suggestive of a particle size—from any topically a MUsT to be necessary to support the causative link, such as skin test results applied sunscreen formulation is safety of this ingredient. positive for zinc oxide. In addition, extremely unlikely, and that any de In addition to the studies described there is an extremely large safety minimis absorption that may occur above, we also located two studies database of zinc oxide use in other would not result in adverse health evaluating the clinical safety of topically topical products, including for the effects, given the high levels of applied zinc oxide in which zinc oxide treatment of diaper rash in infants. This endogenous zinc. The very low (25 percent) was used as a medicated corroborates the negative results in likelihood of any systemic absorption of occlusive dressing on the lower arms of human studies for irritation, zinc oxide in turn indicates that the healthy volunteers (Refs. 38 and 39). In photoirritation, allergy, and safety margin for zinc oxide is large; these studies (which were designed to photoallergy that support our proposed accordingly, consistent with our maximize potential absorption and finding regarding the safety of approach to pediatric studies discussed identify any resulting adverse events), sunscreens containing this ingredient in section VII.B.5, we do not consider even with the increased dermal or under the conditions proposed. Reports pediatric studies to be needed for this epidermal zinc levels resulting from of non-hypersensitivity-related clinical ingredient. We propose to find that the occlusion, there still were no adverse safety issues with zinc oxide were currently available safety data provide skin events. Our review of the available infrequent and not serious. For these sufficient evidence to demonstrate the human dermal safety studies on zinc reasons, we do not consider additional minimal absorption, low dermal oxide 20 also identified data showing clinical studies (including photosafety, irritation, low allergenic sensitization that test material containing up to 25 irritation, or sensitization studies) to be and photoallergenicity, and low percent zinc oxide did not induce necessary for this ingredient. phototoxic potential of zinc oxide— human irritant, photoirritant, allergic, or Dermal carcinogenicity studies have regardless of particle size—up to 25 photoallergic reactions. No human not been conducted for zinc oxide. In percent, and that these data support a pathological phototoxicity or significant general, as discussed in section VII.C.1, finding that zinc oxide up to 25 percent human photosensitization reaction adequate tests for safety of an active is GRASE for use in sunscreens under indicative of skin irritation were noted ingredient for use in topical products for the proposed conditions. Accordingly, either. The literature supporting the chronic use (such as a sunscreen) would we propose that zinc oxide is a Category safety of skin protectant drug products need to include dermal carcinogenicity I active ingredient. containing zinc oxide 21 reinforce these studies if the active ingredient reaches clinical safety findings. Our review in the viable layers of skin where it could 2. Titanium Dioxide this area is also consistent with the have a biological effect. Given the For similar reasons, we propose that conclusion of the European minimal penetration of zinc oxide titanium dioxide is also a Category I Commission’s Scientific Committee on below the non-living stratum corneum, active ingredient. Our review of Consumer Safety that the use of there is no plausible mechanism by information publicly available in the nanoscale zinc oxide in sunscreens at a which zinc oxide could have an effect scientific literature, submissions to the concentration of up to 25 percent does on skin tumor development. We are sunscreen monograph docket, and not pose a risk of adverse effects in therefore proposing to find that zinc FAERS has produced sufficient humans after topical application (Ref. oxide is GRASE for use in sunscreens information to support a proposal that a 40). despite the lack of dermal sunscreen product containing up to 25 A very small number of rash and carcinogenicity studies studying this percent titanium dioxide would be hypersensitivity reports for sunscreens ingredient. GRASE under the conditions proposed containing zinc oxide were located in Based on the minimal systemic in this rulemaking and the general FAERS. With a single exception, the exposure resulting from dermally conditions required in part 330. sunscreens involved contained two or applied zinc oxide, in particular when a. Background. Titanium dioxide is compared to endogenous zinc levels, we an inorganic mineral compound 20 This literature included three clinical safety see no need for further nonclinical consisting of small, crystalline- studies conducted by Hill Top Research, Inc. for studies to support the safety of structured or amorphous particles. It is Procter & Gamble regarding (a) human sensitization widely used as an excipient and is (Study Reports 96–6635–76a and 96–6635–76b); (b) sunscreens containing zinc oxide, human photoirritation/phototoxicity (Study Report including systemic carcinogenicity currently listed as an inactive ingredient 96–6634–76); and (c) human photoallergenicity studies, developmental and in more than 60 approved drug products (Study Report 96–6633–76). See Citizen Petition reproductive toxicity studies, or (including topical, oral, and inhalation submitted by Proctor & Gamble, June 24, 1997 22 products, among others) (Ref. 46). (FDA–1978–N–0018–0639) and the ‘‘Opinion toxicokinetic studies. concerning Zinc Oxide’’ drafted by the European Titanium dioxide particles can be Commission, Scientific Committee on Cosmetic 22 Our review of the available nonclinical safety manufactured to have a variety of Products and Non-Food Products Intended for literature on zinc oxide included references for a different dimensions, shapes (such as Consumers (SCCNFP), which included five 90-day dermal toxicity study, genotoxicity, and spheres or rods), and crystal summaries of human clinical safety studies, all limited developmental and reproductive toxicity evaluating zinc oxide 25 percent (Ref. 40). information. The review of this literature suggests polymorphs (such as anatase or rutile). 21 See, e.g., Beeckman et al. (Ref. 41); 43 FR 34628 that genotoxicity, findings for zinc oxide are mixed, Titanium dioxide (typically with at 34641(August 4, 1978) (discussing use of zinc and that there is minimal dermal toxicity in rodents particle dimensions ranging from 200 to oxide 1 percent to 25 percent as a skin protectant after 90 days. (See Refs. 42 and 43.) Oral rat 300 nm) is manufactured as a white active ingredient: ‘‘Zinc oxide is widely recognized embryofetal toxicity studies showed some adverse as a skin protectant’’ and ‘‘No reports of topical maternal and fetal effects, but only at very high powder for use as a white color pigment toxicity were found in the literature’’ on zinc doses (≤200 mg/kg/day) significantly higher than in pharmaceuticals. Manufacturers have oxide). what is at issue here (Refs. 44 and 45). also introduced processes that produce

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titanium dioxide with particle toxicity, or toxicokinetic) to be Coating titanium dioxide particles has dimensions ranging from 15 to 50 nm to necessary to support the safety of this also been shown to minimize reduce its white/opaque appearance. ingredient.23 Because titanium dioxide photocatalytic activity (and to limit Titanium dioxide particles used in penetration beyond the non-living particle clumping, which can have an sunscreens are also now often treated stratum corneum and into the viable impact on how products blend).25 with chemical coatings (such as layers of the skin is also minimal, as In theory, if photocatalytic activity silicones, metal oxides, or organic acids) with zinc oxide, we do not consider occurred when sunscreen products that are bonded to the exterior surface dermal carcinogenicity studies to be containing nanoscale titanium dioxide of the particles to, among other things, needed for titanium dioxide either. were exposed to light, it could result in improve the aesthetic characteristics of The inability of more than an the breakdown of other sunscreen active the final formulation. extremely minimal amount of titanium ingredients in these products. We have b. Discussion. Titanium dioxide is dioxide to reach viable tissues that no evidence, however, that this in fact essentially insoluble in water and in could have an immunologic reaction occurs in sunscreen products containing biologic fluids (Ref. 47). As with zinc also prevents dermal irritation, titanium dioxide or that there are any oxide, this lack of solubility prevents sensitization reactions, and photosafety other negative impacts resulting from the transdermal absorption of more than issues for this ingredient. Our search of such photocatalytic activity. a de minimis amount of titanium the available literature on titanium Accordingly, its potential for dioxide, regardless of either the dioxide identified nonclinical data photocatalytic activity does not concentration of titanium dioxide or the reinforcing this, showing that dermal undermine our conclusion that titanium formulation of the product (Refs. 48 and toxicity after dermal application of dioxide is GRASE for use in sunscreen 49). Further, unlike zinc oxide, which, titanium dioxide in rodents is minimal products. Nonetheless, we invite if dissolved, would dissociate into zinc (Refs. 57 to 60). Accordingly, we do not comment (including supporting data) on and oxygen (Ref. 50), the chemical consider additional clinical photosafety, whether sunscreens containing titanium stability of titanium dioxide is such that irritation, or sensitization studies to be dioxide are negatively impacted by the it does not dissociate under the necessary to support the safety of this potential photocatalytic effects of that conditions that exist in (or on) the ingredient. We note that the available ingredient and, if so, to what extent; and human body (Ref. 51). Even if titanium studies on titanium dioxide evaluate on additional regulatory conditions, if dioxide were to dissociate into titanium products with titanium dioxide any, that are necessary to address this and oxygen, titanium is unreactive in concentrations up to 10 percent. Given potential issue. physiologic conditions, and (for this, that the physical properties of titanium We note, as well, that it is the among other, reasons) is frequently used dioxide both preclude its penetration responsibility of manufacturers to in medical devices and structures into or through the human skin ensure that any inactive ingredients implanted in the human body (Refs. 51 regardless of concentration and make it used in a drug product marketed and 52). unlikely that there would be dermal pursuant to the OTC Drug Review, The available studies on the photosafety, irritation, or sensitization including coatings used to address transdermal absorption of titanium associated with titanium dioxide photocatalytic activity or for other dioxide confirm that the skin is an exposure (and that there is no data to purposes, are safe and suitable for their effective barrier to the penetration of suggest such photosafety, irritation, or intended use (see § 330.1(e)). FDA titanium dioxide, regardless of particle sensitization would exist at higher encourages manufacturers to contact the size—including those on the nanoscale concentrations), we propose that Agency regarding any specific coatings (Refs. 53, 54, and 55). In our 2012 titanium dioxide—regardless of particle that they are considering for use in a response to the ICTA Petition size—is GRASE for use in sunscreens at topical sunscreen. mentioned earlier, we described the concentrations up to 25 percent, c. Conclusion. Given the chemical then available information about the consistent with the level set in the properties of titanium dioxide as absorption of titanium dioxide Stayed 1999 Final Monograph. insoluble and unreactive under nanomaterials and concluded that the In evaluating whether titanium physiologic conditions and the available ‘‘currently available literature indicates dioxide is GRASE for use in sunscreen studies showing that titanium dioxide that insoluble nanomaterials of titanium products, we have considered published does not penetrate into the skin or enter dioxide used in sunscreens do not literature indicating that nanoscale into systemic circulation to any penetrate into or through human skin to titanium dioxide can exhibit meaningful extent, we consider the produce adverse health effects when photocatalytic properties (Ref. 61). The available safety data adequate to support applied topically’’ (ICTA Petition literature indicates that the crystalline a proposal that titanium dioxide is Response at 26). Since that time, our structure of titanium dioxide particles GRASE for use in sunscreens. As with search of the available literature has not plays a role in this photocatalytic zinc oxide, our proposal rests in revealed anything that would change activity, and that the anatase crystalline significant part on the data showing that this conclusion. Because topically polymorph is associated with greater absorption of titanium dioxide into or applied titanium dioxide particles do photocatalytic activity than the rutile through the skin is very unlikely and not enter systemic circulation to any polymorph (Ref. 61). The European meaningful extent, we do not consider Commission has established limitations Consumer Safety gave its opinion that titanium a MUsT to be necessary for this on the percentage of anatase crystalline dioxide particles consisting, among other things, of ingredient. polymorph in titanium dioxide to up to 5 percent anatase crystal ‘‘can be considered to not pose any risk of adverse effects in humans Given the lack of transdermal 24 minimize photocatalytic activity. after application on healthy, intact or sunburnt absorption of titanium dioxide beyond a skin’’ (Ref. 62). In 2016, this physicochemical de minims amount and, as a result, the 23 We note that the available literature also parameter was incorporated by the European very low likelihood of any systemic includes data showing that oral administration of Commission into its Regulation on Cosmetic effects, we also do not consider relatively high doses of titanium dioxide did not Products (Regulation (EC) No. 1223/2009 11/30/ produce adverse fetal effects in rats. (See Ref. 56.) 2009) permitting the use of titanium dioxide as a additional nonclinical studies 24 In a July 2013 opinion addressing the safe use UV filter or as a colorant in cosmetics. See (including systemic carcinogenicity, of titanium dioxide in sunscreen products, the Regulation (EC) No 1143/2016 July 13, 2016. developmental and reproductive European Commission’s Scientific Committee on 25 Id.

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that any de minimis absorption that number one recommended treatment for salicylate would not be GRASE. We note could theoretically occur would not hypertension for certain communities), that, as with PABA, our review of more result in adverse health effects. As a certain local anesthetics (such as than 700 sunscreen brands sold in the result, the safety margin here is large, benzocaine and procaine), and dyes United States suggests that trolamine and consistent with our approach to (including para-phenylenediamine (a salicylate is no longer being marketed in pediatric studies discussed in section hair dye) and aniline dyes (used in sunscreens sold in the United States VII.B.5, we therefore consider pediatric medical products)) (Refs. 70, 71, and (Ref. 63). studies to be unnecessary for this 72). Cross-sensitization to these a. Background. Trolamine salicylate is ingredient. products is a serious concern, as comprised of trolamine and salicylic widespread PABA use could result in a acid. Salicylic acid is a non-steroidal B. Ingredients Proposed as Category II significant increase in cross-reactivity anti-inflammatory drug (NSAID); it is FDA’s review of the available safety with these agents and the incidence of the active moiety in aspirin, and has data for PABA and trolamine salicylate allergic and photoallergic dermatitis, been widely used as an analgesic (i.e., have caused us to conclude that the some of which are likely to be severe. pain relieving), anti-pyretic (i.e., fever risks associated with use of these These safety issues alone are reason reducing), and anti-inflammatory agent. ingredients in sunscreen products enough to find PABA not GRASE for use In addition to these properties, salicylic outweigh their benefits. Accordingly, in sunscreens. In addition, however, acid inhibits platelet aggregation, which we are proposing that these two data obtained from the urine samples of in turn inhibits blood coagulation. For ingredients are Category II. human subjects receiving topical PABA this reason, some salicylic acid- 1. Para-Aminobenzoic Acid application shows that PABA also containing products (such as aspirin) penetrates the skin and enters systemic are used by consumers to help reduce PABA use has decreased significantly circulation (Ref. 73). Because full MUsT cardiovascular adverse events, in recent years because of, among other studies for PABA have not been done, including myocardial infarction, stent things, its adverse effects on skin and its it is unclear to what degree such thrombosis, and transient ischemic discoloring and staining effect on transdermal absorption takes place. attacks. clothing. Our review of more than 700 However, one article in the published Trolamine salicylate was included in sunscreen brands sold in the United literature suggests that there is an the Stayed 1999 Final Monograph for States (Ref. 63) indicates that PABA is association between autoimmune sunscreens at a concentration of up to in fact no longer being marketed in the disorder and PABA use (Ref. 71), and 12 percent. It was also proposed as a United States. we found one report each of Category III active ingredient in the A search of the scientific literature, hepatotoxicity (Ref. 74) and chronic tentative final monograph for OTC submissions to the sunscreen interstitial nephritis (Ref. 75) after oral external analgesic drug products monograph docket, drug approval PABA administration. Although it is (External Analgesic TFM) (‘‘External documents from FDA and the European difficult to determine causality on the Analgesic Drug Products for Over-the- Medicines Agency, adverse event basis of such single reports, if a MUsT Counter Human Use; Tentative Final reports submitted to FAERS, and FDA were to show absorption of PABA, these Monograph,’’ 48 FR 5852 at 5855 Advisory Committee meeting reports reports could represent an additional (February 8, 1983)). The mechanisms of (among other sources) has produced safety concern. action for trolamine salicylate for these clinical safety data on PABA that In addition, genotoxicity findings two drug categories are very different; to supports a conclusion that a sunscreen with PABA use have been largely be effective as an external analgesic, containing PABA would not be GRASE. negative in the absence of UV trolamine salicylate must penetrate the The available clinical information irradiation. Adequate assessments of the skin and reach the relevant sites of includes significant numbers of reports dermal carcinogenicity potential of action. The available evidence clearly of allergic and photoallergic skin PABA are unavailable, as are DART establishes that trolamine salicylate is reactions to PABA, with rates of PABA- studies. If a MUsT were to show transdermally absorbed (Refs. 76 and induced skin reactions potentially 8 absorption of PABA, therefore, 77). To be effective as a sunscreen, percent or higher (Refs. 64 to 67). An 8 necessary studies would include dermal however, trolamine salicylate must be percent incidence is a serious concern: and systemic carcinogenicity studies, present on the surface of the skin so that By comparison, only 34 hypersensitivity DART studies, and toxicokinetic it can reflect, scatter, or absorb UV reactions associated with sunscreen studies. However, given that the above- radiation. products have been identified in FAERS described safety concerns associated The directions for use for the two 26 since 1969. with PABA are significant enough to product categories differ significantly as Further, PABA has the ability to cause place PABA in Category II, conducting well. The current requirements for cross-sensitization to structurally such testing is neither appropriate nor sunscreen labeling include directions similar aromatic amines and nitro ethical. We propose that PABA is not that the product should be applied to all compounds (i.e., it can cause GRASE for use in sunscreens. skin exposed to the sun, that it should individuals exposed to it to develop be used ‘‘regularly’’ to decrease the risk sensitivity reactions to similar 2. Trolamine Salicylate of skin cancer and early skin aging,27 compounds) (Ref. 69). The list of We also propose that trolamine and that it should be reapplied at least compounds at issue includes a variety salicylate is not GRASE for use in every 2 hours (21 CFR 201.327). In of widely used products, such as sunscreens, and is, like PABA, a contrast, currently marketed external sulfonamide antibiotics (commonly Category II active ingredient. As analgesic products containing trolamine used to treat a variety of infections, from described in further detail below, there salicylate include directions for use urinary tract infections to certain types are significant safety concerns of pneumonia), thiazide diuretics (the stating that they should be applied to associated with the use of trolamine ‘‘affected areas,’’ that they should be salicylate in sunscreen products. We reapplied no more than three to four 26 Total sunscreen sales since 1969 are not readily propose that these concerns are available. However, in 2016 a total of 161,882,779 sunscreen units were sold in the United States (Ref. sufficient to support a conclusion that a 27 This direction applies to sunscreens with an 68). sunscreen containing trolamine SPF of 15 or greater that are also broad spectrum.

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times a day, and that use should be subsequent symptoms suggesting a more (including the potential for salicylism discontinued after 7 days.28 severe intoxication include altered associated with exposure to high doses b. Significant safety concerns mental status (ranging from agitation to of trolamine salicylate) would raise associated with use of trolamine lethargy), hyperpyrexia, noncardiac significant ethical concerns about the salicylate as a sunscreen. FDA is pulmonary edema, and coma.29 conduct of a MUsT in these concerned that use of trolamine If trolamine salicylate were to be circumstances. Were it possible to salicylate as an active ingredient in applied to all skin exposed to the sun ethically conduct a MUsT for this sunscreens could cause serious and reapplied every 2 hours as directed ingredient, and if such a MUsT showed detrimental health effects due to the in sunscreen labeling, the potential for significant transdermal absorption of anti-coagulation effects of salicylic acid. transdermal absorption and systemic trolamine salicylate, this would raise FDA located two case reports of serious availability of substantial amounts of questions about whether enough of this coagulation-related adverse events salicylic acid raises significant concerns ingredient remains present on the associated with liberal dermal about the potential for increased surface of the skin for it to function application of trolamine salicylate. The occurrence of the above-described effectively as a sunscreen. As we noted first case involved a surgical patient adverse events. This is a particular in section VII.B.4, such considerations who experienced coagulopathy concern given the widespread use of ultimately weigh into the risk-benefit (impairment of the blood’s ability to other OTC NSAID products with anti- calculus FDA uses to determine whether coagulate) at surgical sites in connection inflammatory, analgesic, or anti-pyretic an active ingredient would be GRASE with use of topical trolamine salicylate effects, which, combined with the use of for use in sunscreens. (Ref. 76). Although the patient sunscreens containing trolamine Although we have data addressing the discontinued aspirin use 2 weeks before salicylate, may raise the anti-platelet toxicology profile of salicylate, surgery per her doctor’s instructions, effects experienced by consumers to adequately detailed nonclinical DART she was unaware that use of a topical problematic levels. Concerns relating to studies for trolamine and toxicokinetic cream containing trolamine salicylate transdermal absorption may be data to interpret DART studies were also should have been stopped as well, and especially acute for children, who have not found in the public record. continued liberal application of the a higher surface-area-to-body-weight Adequate DART information, if it were product to her knees for arthritis pain in ratio than adults. FDA proposes that the available, might reveal additional data the period leading up to her surgery. above-described safety concerns are needs (for example, to address any Four hours after surgery, the patient enough, by themselves, to support a potential hormonal effects that may be returned to the operating room bleeding finding that trolamine salicylate is not identified). Dermal carcinogenicity data profusely from all surfaces that had GRASE for use in sunscreens, and are available from the National been operated on and experiencing therefore, is a Category II active Toxicology Program for trolamine in massive bilateral hematomas. She lost ingredient. acetone and trolamine alone (applied more than 900 mL of blood. c. Data gaps. In addition, there are neat).30 In the absence of toxicokinetic In the second case, a patient taking several categories of data about data to interpret existing carcinogenicity warfarin (an anticoagulant) for atrial trolamine salicylate that FDA expects studies, we cannot determine how the fibrillation and stroke prevention would be necessary to support a exposure in the animal studies relates to experienced a considerable increase in positive GRASE determination for its human exposure to trolamine from the prothrombin time (i.e., the time it takes use in sunscreen products that are use of trolamine salicylate as a for blood to coagulate) after liberal currently missing from the public sunscreen active ingredient. application of trolamine salicylate to his record. For example, there is d. Conclusion. For the reasons neck and shoulders for pain relief (Ref. insufficient clinical dermal described above, FDA proposes that 78). The patient’s prothrombin time had sensitization, irritation, and photosafety trolamine salicylate is not GRASE for previously been in the therapeutic range data for trolamine salicylate. Although use in sunscreens. The safety concerns of 1.3 to 1.5 times the control, but the transdermal absorption of trolamine associated with the use of trolamine increased to 2.5 times the control during salicylate is well established, the record salicylate as an active ingredient in trolamine salicylate use. When currently lacks a MUsT that would sunscreens are significant enough to trolamine salicylate use was allow us to evaluate the extent of support classification of trolamine discontinued, the patient’s prothrombin exposure to this ingredient when it is salicylate as a Category II ingredient. In time returned to 1.3 times the control. used as a sunscreen. Such data is particular, the potential for transdermal FDA is also concerned that important because it would allow FDA absorption and systemic availability of sunscreens containing trolamine to interpret systemic toxicity findings in substantial amounts of salicylic acid in salicylate could lead to other adverse animal toxicology studies in the context connection with the exposure resulting effects associated with salicylic acid of the amount likely to be absorbed from from the use of trolamine salicylate in exposure. These include gastrointestinal sunscreen use. Given the FDA sunscreens raises concerns about distress and hemorrhage, ototoxic recommendation that a MUsT for increased occurrence of the above- effects (i.e., impacts on hearing), sunscreen use include application to a described serious adverse events hypersensitivity reactions, asthma majority (75 percent at a minimum) of (including salicylism and serious exacerbations, acid-base imbalance, salt the body surface of each test subject, the coagulation-related issues). The record and water retention, liver injury, and above described safety concerns also contains several significant data Reye’s Syndrome (in children). At high gaps that would need to be addressed to 29 doses, acute salicylate toxicity The symptoms associated with both acute and support a positive GRASE chronic salicylate toxicity are well established. determination for trolamine salicylate. (salicylism) may occur. Early symptoms Descriptions are available from many sources, of salicylism include tinnitus, vertigo, including: National Library of Medicine’s 30 nausea, vomiting, and diarrhea; Toxicology Data Network (ToxNet), ‘‘Salicylic In mice, liver tumors were identified, providing Acid,’’ September 2008, available at https:// evidence of systemic absorption of trolamine, but toxnet.nlm.nih.gov/cgi-bin/sis/search/ the suspected mechanism of action is likely not 28 Based on an evaluation of product labeling a?dbs+hsdb:@term+@DOCNO+672 (accessed March relevant to humans (Refs. 79 and 80). A causal link available at https://labels.fda.gov (accessed April 4, 27, 2018). FDA also included a comprehensive between the proposed mechanism and tumor 2018). See also External Analgesic TFM. summary of salicylism in 21 CFR 343.80. formation in mice is lacking.

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Given the safety concerns described similar to many of these 10 sunscreen positive GRASE findings for above, however, conducting the clinical active ingredients are among those oxybenzone and avobenzone, we have absorption testing recommended to successfully delivered transdermally— significantly more data for these two address these gaps for use as a and therefore available systemically ingredients than for the ingredients sunscreen raises ethical concerns. (Ref. 85). This reinforces the potential discussed in the preceding section. To for transdermal absorption of and help facilitate submission of the C. Ingredients Proposed as Category III systemic exposure to these sunscreen remaining data, we describe the data The public record does not contain ingredients. The potential for such gaps for these two ingredients in greater sufficient data to support a positive systemic exposure is a concern because detail below. GRASE determination for cinoxate, the available data are inadequate to a. Oxybenzone data. Although we dioxybenzone, ensulizole, homosalate, determine either the level of systemic located substantially more data on meradimate, octinoxate, octisalate, exposure to these active ingredients or oxybenzone than on the ingredients octocrylene, padimate O, sulisobenzone, the potential unintended consequences discussed in section VIII.C.1, our review oxybenzone or avobenzone at this time. of such exposure. Given the lack of of the scientific literature, submissions Accordingly, these ingredients are being chronic exposure toxicology data for to the sunscreen monograph docket, and proposed as Category III. In the sections these 10 ingredients—which makes an postmarket safety data publicly that follow, we discuss our review of the evaluation of the dermal and systemic available through FAERS revealed available safety evidence for these effects of chronic use impossible—this significant gaps in the data we expect to ingredients and identify the existing is especially concerning. A number of be necessary to support a positive data gaps. these active ingredients have also GRASE finding for use of oxybenzone at 1. Ingredients for Which the Record shown hormonal effects in mammalian a concentration of up to 6 percent in Contains Significant Data Gaps: assays (homosalate (Refs. 86 to 92)) and sunscreen products. The available Cinoxate, Dioxybenzone, Ensulizole, padimate O (64 FR 27666 at 27671) and literature includes studies indicating Homosalate, Meradimate, Octinoxate, in in vitro and in vivo assays that oxybenzone is absorbed through the Octisalate, Octocrylene, Padimate O, (homosalate (Refs. 86 to 92), octinoxate skin and can lead to significant systemic and Sulisobenzone (Refs. 93 and 94),and octocrylene (Ref. exposure, as well as data showing the 95). Although these findings are only presence of oxybenzone in human The most significant gaps in the preliminary, we do not have adequate breast milk, amniotic fluid, urine, and administrative record exist for the DART studies to enable us to assess the blood plasma. The significant systemic following active ingredients: Cinoxate, impact of these potential hormonal availability of oxybenzone (and, as dioxybenzone, ensulizole, homosalate, effects on development and discussed further below, the lack of data meradimate, octinoxate, octisalate, reproduction. evaluating the full extent of its octocrylene, padimate O, and In addition, several of these 10 absorption potential) is a concern, sulisobenzone. We expect that data from ingredients (homosalate (Refs. 81 and among other reasons, because of all the types of studies described in 84), octinoxate (Refs. 81 and 96 to 101), questions raised in the published section VII will need to be submitted to octisalate (Refs. 81, 84, and 101 to literature regarding the potential for support general recognition of safety 105),octocrylene (Refs. 95 and 106), endocrine activity with systemic and effectiveness for each of these padimate O (Ref. 100), and oxybenzone exposure. Accordingly, we ingredients. sulisobenzone (Refs. 107 and 108)) have expect that a positive GRASE finding for Only three of these active ingredients been studied in dermal penetration oxybenzone-containing sunscreens (homosalate (Ref. 81)), octinoxate (Refs. studies, which show (in general, with would require, among other things, both 81 to 84), and octisalate (Ref. 81), for the exception of homosalate) that these a MUsT showing the degree of example, appear to have been evaluated ingredients permeate into the epidermis oxybenzone absorption under maximal in human absorption studies, and most and/or dermis. The studies show that usage conditions and DART studies that of the available absorption studies for there are several factors (including fully investigate its potential endocrine- these three ingredients had significant vehicle composition and the presence of disrupting effects. We found neither in limitations. For example, the studies use other active ingredients) that can the existing record. a limited number of subjects or are influence, and potentially increase, the The record also lacks systemic and based on only a single application of the permeation and/or penetration of these dermal carcinogenicity studies for sunscreen active ingredient to a limited ingredients. oxybenzone; these (and toxicokinetic area of the body. Even with this limited Because the record does not currently data) should also be provided to support sunscreen exposure, some of these contain sufficient data to support their a positive GRASE finding for this studies showed systemic availability of safety, we are proposing that cinoxate, ingredient. Finally, the available the active ingredient (octinoxate (Refs. dioxybenzone, ensulizole, homosalate, literature also raises questions about the 83 and 84)). None of these 10 meradimate, octinoxate, octisalate, safety of use of oxybenzone-containing ingredients has been studied in an octocrylene, padimate O, and sunscreens in young children because of adequate and well-controlled MUsT that sulisobenzone are Category III the potential for higher absorption and would determine the amount of ingredients. As previously noted, we bioaccumulation of oxybenzone in this systemic exposure to the active expect that data from all the types of population. As discussed in further ingredients under conditions of studies described in section VII will be detail in the sections that follow, we maximal use. needed to support general recognition of invite input and comment on We note that a recent publication safety and effectiveness for these appropriate studies and/or age examining the relationship between ingredients. restrictions to address these pediatric melting point, molecular weight, and issues. the transdermal delivery rates of the 2. Ingredients for Which the Record b. Background of oxybenzone. Unlike active ingredients in approved drug Contains Fewer Data Gaps: Oxybenzone zinc oxide and titanium dioxide, both of products shows that products and Avobenzone which are inorganic (or physical) UV containing active ingredients with While the record does not currently filters consisting of metal oxides that melting points and molecular weights contain sufficient data to support primarily reflect or scatter UV radiation,

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oxybenzone is an organic (or chemical) 110). As discussed below, however, of oxybenzone is high (Refs. 82, 115, filter, which absorbs UV radiation. It evidence shows that oxybenzone also and 116). One study involving sampling belongs to a class of aromatic ketones has contact allergenic and of plasma and urine following topical known as benzophenones and has a UV photoallergenic potential (Ref. 111). In application of an oxybenzone- absorption profile covering both UVA addition to its use as a sunscreen active containing formulation showed and UVB wavelengths (Ref. 109). ingredient, oxybenzone is used in, absorption and significant systemic Because of its superior UVA coverage, among other things, perfumes, lipsticks, availability of oxybenzone (Ref. 82). In oxybenzone was increasingly used hair sprays, and conditioners as a this study, 15 men and 17 women were through the early 1990s and ultimately photostabilizer and/or fragrance dosed once daily, applying a 10 percent enhancer (Refs. 112 to 114). replaced PABA in sunscreen products oxybenzone cream formulation to (Ref. 110). Use of oxybenzone in c. Data showing transdermal approximately 90 percent of the body’s sunscreens increased when ‘‘PABA- absorption and significant systemic surface area for 4 days. The figures free’’ sunscreens were introduced into availability of oxybenzone. Data that the market because of recognition that have become available since publication below illustrate the plasma and urine PABA and its esters induced contact of the Stayed 1999 Final Monograph levels observed. and photocontact allergic reactions (Ref. suggest that the transdermal absorption BILLING CODE 4164–01–P

BILLING CODE 4164–01–C

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BILLING CODE 4164–01–C UV radiation on oxybenzone absorption, d. Inadequate data on oxybenzone’s Although this study provides the sunscreen was applied to study developmental and reproductive important information about the subjects twice daily for 5 days. toxicity. The significant systemic significant absorption potential of Although the study concluded that UV availability of oxybenzone following oxybenzone, it does not obviate the exposure did not significantly affect the topical application and the lack of data need for a MUsT. Among other things, urinary excretion of oxybenzone, it fully characterizing its absorption levels once-daily application may result in provided further evidence of the are concerns, among other reasons, substantially lower systemic exposure systemic availability of oxybenzone because of literature suggesting that than application at least every 2 hours following topical application and oxybenzone may have endocrine (as sunscreen labeling directs). This showed that renal excretion of activity (see, e.g., Refs. 88, 92, and 117). difference in application frequency is a oxybenzone continued for 5 days after Dermal exposure to oxybenzone (in particular concern given that the data the last application of the sunscreen. acetone) in rats and mice and oral show oxybenzone levels would still be Although the use of a commercial feeding of oxybenzone to rats and mice increasing at the time of reapplication if sunscreen formulation, and twice- resulted in reduced sperm density in a 2-hour application window were rather than once-daily sunscreen males in 13-week general toxicity observed. Additionally, the cream application are improvements over the studies conducted by the National formulation used in the study was not formulation and application frequency Toxicology Program (NTP) (Ref. 118). In formulated as a sunscreen product and used in the previous study, twice-daily female rats and mice, increased estrous may have contained ingredients not application remains insufficient to cycle length was observed in 13-week typically used in sunscreen approximate the recommended oral feeding studies.31 Importantly, the formulations, and/or lacked other application frequency of sunscreen actual effects of oxybenzone on female ingredients typically present. Because products in real-world use. fertility were not evaluated. In a the formulation can have an impact on Furthermore, because the study used a preliminary dose range-finding pre- and absorption, the absorption results sunscreen with 4 percent rather than the postnatal development study in rats, produced by the study may not reflect full 6 percent concentration of findings in male offspring indicated that absorption levels that would result from oxybenzone eligible for the sunscreen cells in the testes undergoing actual use of oxybenzone-containing monograph, its results may not fully programmed cell death were increased sunscreen products. reflect the absorption that would result in all oxybenzone-exposed animals and Another study, which evaluated the from use of a 6 percent oxybenzone- that numbers of spermatocytes in the transdermal absorption of a marketed containing product. To properly testes were markedly reduced after oral sunscreen containing 4 percent characterize the potential for absorption feeding at oxybenzone (Ref. 119). oxybenzone in 16 women and 9 men, of oxybenzone in sunscreen products Although these findings are notable, showed prolonged systemic availability and to determine a margin of safety for they are all derived from dermal studies of oxybenzone following topical use of oxybenzone at up to 6 percent in exposure (Ref. 116). In this study, which sunscreen products, we expect that a 31 These changes could potentially be addressed was designed to evaluate the effects of MUsT will be needed. with historical control data (Ref. 88).

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with oxybenzone in acetone and oral interest (Ref. 115) to support a positive 2010 (see, e.g., Ref. 125). From 2001 to feeding studies of oxybenzone; these GRASE finding for this ingredient. The 2008, oxybenzone was tested at 3 methods of exposure could potentially results from the metabolite study will percent; from 2009 to 2010, the lead to higher levels of systemic inform whether additional nonclinical concentration used for the test was exposure to oxybenzone than with studies assessing oxybenzone’s increased to 10 percent. Of the 23,908 sunscreen use. Accordingly, a MUsT metabolites should be conducted to patients patch tested, only 82 patients and toxicokinetic data are needed to support its safety. We note that the NTP (0.34 percent) had positive test patch determine the relevance of these is currently conducting additional results with oxybenzone. In addition, a findings to human use of oxybenzone as DART studies on oxybenzone (although search of FAERS for case reports of a sunscreen active ingredient. their embryofetal studies do not appear hypersensitivity reactions to In humans, the endocrine effects of to include an assessment in a nonrodent oxybenzone-containing sunscreen oxybenzone have been studied with species) (Ref. 122).33 products resulted in only 31 cases (4 inconclusive results (see, e.g., Refs. 83, e. Inadequate carcinogenicity and with anaphylaxis) between 1988 and 120, and 121). In biomonitoring studies toxicokinetic data for oxybenzone. High 2011. Because sufficient data exist to of pregnant and lactating women, population exposure to oxybenzone, make a determination, we do not oxybenzone has been detected in breast coupled with a lack of carcinogenicity consider additional dermal irritation or milk, amniotic fluid, and urine samples testing for this ingredient, caused the sensitization studies to be necessary to (Ref. 83, 120, and 121). High levels of National Cancer Institute to nominate support a positive GRASE finding for oxybenzone in the urine of mothers oxybenzone for toxicology testing in oxybenzone up to 6 percent. As is have been associated with: (1) 1979 (Ref. 123). The NTP reports that customary in clinical trials, however, Decreased birth weight in girls and (2) 2-year oral (dosed feed) carcinogenicity we recommend that dermal safety data increased birth weight and head studies in rats and mice are in a draft for oxybenzone be collected during circumference in boys, both of which report stage, but results are not yet MUsT studies. can be indications of endocrine effects publicly available (Ref. 122). In Nevertheless, the overwhelming (Ref. 83). This association is particularly addition, no reports of either ongoing or majority of results from available concerning given the widespread planned dermal carcinogenicity studies studies (see, e.g., Refs. 125 to 136) exposure of the U.S. population to for oxybenzone have been published. To addressing allergic contact dermatitis oxybenzone. Estimates suggest that support a positive GRASE finding for for oxybenzone show that oxybenzone is oxybenzone (from all sources) is present oxybenzone, carcinogenicity data from an allergen for persons with preexisting in the urine of 97 percent of the U.S. well-conducted dermal and systemic skin conditions. Because the evidence population, and that oxybenzone carcinogenicity studies should be establishing oxybenzone as a concentrations are higher in women provided. Toxicokinetic data in rodents photoallergen in individuals with than in men (possibly because women (oral and dermal) and rabbits (oral) are photosensitivity is clear, no further are more likely to use sunscreen and also recommended; these data could be dermal photosafety studies to other personal care products containing obtained from either stand-alone studies characterize this risk are needed. oxybenzone, leading to greater or as part of DART and dermal However, if we were to receive adequate cumulative exposure) (Ref. 83 and 115). carcinogenicity studies. data to support a positive GRASE Because current data suggest that Our search of the available literature finding for oxybenzone, we would oxybenzone may affect the human also revealed information suggesting consider requiring labeling language to endocrine system, FDA believes that a that oxybenzone may generate reactive address the risk of allergic reactions positive GRASE determination for oxygen species (ROS) 34 in the presence associated with oxybenzone use. We oxybenzone would require that its of UV light, but that this issue, and the invite comment on whether such potential toxicities have been fully harms associated with it, have not been labeling should be required for explored, including through DART fully explored (Ref. 124). We invite sunscreens containing oxybenzone and, studies (fertility and early embryonic comment and input on the extent to if so, what that labeling should entail. studies in rodents, embryofetal which ROS generation is a concern for g. Safety questions regarding use of development studies in rodent and sunscreens containing oxybenzone and oxybenzone in pediatric populations. nonrodent species, and pre- and whether additional data on this topic Sunscreens are currently labeled for use postnatal development studies in are needed. in children as young as 6 months old. rodents). In addition, as noted below, f. Dermal safety of oxybenzone. The The available literature, however, toxicokinetic data are needed to available data indicate that oxybenzone includes several publications that raise interpret these studies. We note that, if (at concentrations up to 6 percent) has concerns about the use of sunscreens the results of DART studies do not a favorable safety profile with respect to containing oxybenzone in young resolve the concerns raised in the irritation and sensitization potential. children. Among these publications is a literature relating to potential endocrine For example, the North American 2006 report from the Swedish Research disruption, it may still be possible to Contact Dermatitis Group conducted an Council noting that children under the resolve these concerns through analysis of patients who were patch age of 2 years old have not fully additional testing.32 In addition, tested for allergies between 2001 and developed the enzymes believed to because of the potential risk posed by metabolize oxybenzone (Ref. 137), metabolites of oxybenzone (existing 33 As a reminder, such data must be generally which suggests, in theory, that small reports suggest that some oxybenzone available to be considered as part of this rulemaking children may not be able to eliminate process. Once available, FDA intends to review oxybenzone as easily as adults. The metabolites are more hormonally active such data to determine whether it resolves than the parent drug (Ref. 109)), we particular data concerns we have in this area. possibility for bioaccumulation in recommend that the analytical method 34 Reactive oxygen species are ‘‘a type of unstable children, taken together with the used in the MUsT be validated for both molecule that contains oxygen and that easily reacts potential increased absorption of with other molecules in a cell. A buildup of ROS oxybenzone in young children (due to the parent and the metabolites of in cells may cause damage to DNA, RNA, and proteins, and may cause cell death.’’ https:// their greater body surface-area-to-weight 32 For examples of the type of studies that could www.cancer.gov/publications/dictionaries/cancer- ratio) and the potential harms associated be explored at that juncture see Ref. 21. terms?cdrid=687227. with absorption discussed above,

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militates in favor of caution when using h. Conclusion. Given the available bridge between animal and human data. oxybenzone products in young children. data showing significant transdermal We seek any existing data on the Accordingly, we are seeking any absorption and systemic availability of pediatric safety of oxybenzone. We also existing pediatric data on the safety of oxybenzone, as well as the potential for seek comment on whether additional oxybenzone use in children under 2 endocrine activity, we propose that safety data are needed to support the years old. We are also requesting input oxybenzone is not GRASE for use in use of sunscreens containing on: (1) Whether additional data on the sunscreens without further data. As oxybenzone on children under 2 years safety of oxybenzone use in young described above, a MUsT should be of age, as well as comment on whether children is necessary to support the use conducted to fully characterize the these sunscreens should be of oxybenzone-containing sunscreens in absorption of oxybenzone and to contraindicated for use in this children under 2 years of age (taking calculate a margin of safety for human population. We note that, because of the into consideration the practical hurdles use. As part of the MUsT, we believe risk of allergic reactions associated with that a study of oxybenzone’s metabolites oxybenzone use, if we receive adequate involved in conducting studies in in humans is also necessary; the results data to support a positive GRASE children of this age) or (2) whether of this study will inform whether finding for oxybenzone, we may require sunscreen products containing additional nonclinical studies with labeling to address this risk. We seek oxybenzone should instead be metabolites are needed to address comment on whether such labeling contraindicated for use in children potential endocrine effects. Given that should be required for sunscreens younger than 2 years (given, among oxybenzone demonstrates significant containing oxybenzone and, if so, what other things, the availability for use as systemic absorption, FDA believes that such labeling language should entail. sunscreen active ingredients of physical data on carcinogenicity (both systemic In summary, table 3 shows the UV filters like titanium dioxide and zinc and dermal) and developmental/ additional studies that FDA anticipates oxide, which do not raise the same reproductive toxicity are likely to be would be necessary to support a questions about safe use in young needed to support the safety of this positive GRASE finding for sunscreens children). ingredient, as are toxicokinetic data to containing oxybenzone.

TABLE 3—SUMMARY OF RECOMMENDATIONS: STUDIES FOR OXYBENZONE UPTO6 PERCENT

Safety studies FDA proposes are necessary to support a GRASE determination Additional studies or data necessary?

Pharmacological Studies: Human absorption (MUsT) (including metabolite study in humans) Yes. Nonclinical Safety Studies: Toxicokinetics ...... Yes. Dermal Carcinogenicity ...... Yes. Systemic Carcinogenicity ...... Yes. DART: 1 ...... Yes. Fertility and early embryonic development. Embryofetal development in two species (rodent and non-rodent). Prenatal and postnatal development. Clinical Safety Testing: Skin irritation and sensitization ...... No. Skin photoallergenicity and phototoxicity ...... No. Pediatric studies ...... Seeking input on whether additional studies or contraindication are necessary to support the safety of sunscreens containing oxybenzone for children under 2 years of age. 1 As noted above, if DART studies do not resolve the concerns raised in the literature relating to potential endocrine disruption, it may be pos- sible to resolve these concerns through additional testing.

i. Avobenzone data. Our review of the avobenzone’s chemical properties sunscreen active ingredient that available scientific literature, suggest that sunscreen products provides protection in the UVB range. submissions to the sunscreen containing avobenzone have a potential Avobenzone exhibits greater monograph docket, and publicly for absorption. There are also other gaps photoinstability than other UV available FAERS data also revealed in the record, including (as discussed absorbers; the available evidence shows significant gaps in the data we expect to below) dermal carcinogenicity data, that avobenzone degrades quickly upon be necessary to support a finding that toxicokinetic data, and—potentially, exposure to sunlight, which can cause avobenzone (at up to either 3 percent or depending on the outcome of MUsT its efficacy to be decreased by between 5 percent, as discussed below) is GRASE studies assessing the absorption of 50 and 90 percent after 60 minutes of for use in sunscreens. Most critically, avobenzone—systemic carcinogenicity exposure to sunlight (Refs. 138 and we encountered no studies examining and additional DART studies. 139).35 To address this, avobenzone is the absorption of avobenzone in vivo, Accordingly, we propose to find that typically combined with a and those in vitro studies we located avobenzone is Category III. photostabilizer to prevent rapid had several weaknesses that limit their j. Background of avobenzone. photodegradation (Refs. 138 and 139). usefulness in assessing the potential Avobenzone, like oxybenzone, is an absorption of avobenzone from organic (chemical) UV filter. Because 35 Avobenzone’s photodegradation also results in formulated sunscreen products. This is the formation of free radicals, which could, in avobenzone primarily absorbs radiation theory, create sensitization and irritation responses a concern given that, as explained in in the UVA portion of the UV spectrum, and increase long-term risk of skin cancers and further detail below, certain of it is typically combined with another photoaging (Ref. 139).

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k. Potential for absorption of adhesive tape to the skin samples. expected (Refs. 142 and 143)). In avobenzone. Although avobenzone is However, it is unclear whether the addition, the study’s use of not soluble to any great extent in water, receptor phase of the study created commercially marketed sunscreen it is soluble in organic solvents. These adequate sink conditions. In addition, formulations (which, as discussed include oils (which are present on the formulations used in the study above, typically contain multiple human skin), alcohols, and other (which, as noted previously, consisted permeation/absorption-enhancing substances regularly included in of only water, mineral oil, and the excipients) more accurately reflects the sunscreen product formulations. sunscreen ingredient) did not contain absorption potential of marketed Although this solubility is not enough, any of the other types of excipients sunscreen products. by itself, to determine whether (such as emollients, stabilizers, or Despite these improvements, the transdermal absorption will take place, solubilizers) that can also function as usefulness of the study was limited by it is a necessary precondition (Ref. 140). permeation/absorption enhancers and its use of an analytical method that In addition, like the 10 active that are typically present in sunscreen prevented the detection of any ingredients described in section product formulations. The study results avobenzone absorption below 100 ng/ VIII.C.1, avobenzone’s melting point showed that there was avobenzone mL. This level of absorption is hundreds and molecular weight are similar to present in the stratum corneum, the of times higher than what is relevant for those of active ingredients in approved epidermis, and the viable dermis of the our considerations in assessing the drug products that are successfully skin used as the membrane, but not in acceptable absorption level from a delivered transdermally and therefore the receptor fluid. Although the lack of topically applied product. The available systemically (Ref. 85). As with avobenzone in the receptor fluid is concentration of avobenzone used in the the 10 sunscreen active ingredients encouraging, the other characteristics of study (ranging from 0.2 percent to 1 previously discussed, this suggests a the study limit its value in assessing the percent) is also significantly lower than potential for transdermal absorption of actual absorption potential of what is relevant for our current avobenzone. avobenzone used in sunscreen products. consideration of maximum l. Lack of adequate data on The second in vitro study (Ref. 141) concentration of this ingredient. transdermal absorption of avobenzone. we located suffered from similar Although avobenzone was only Nevertheless, our review of the available limitations. This study assessed the absorbed to a very small extent (between literature on avobenzone failed to avobenzone permeation observed using 3 percent and 3.96 percent) under these produce any studies evaluating the in a static cell (as generally described study conditions, these weaknesses in vivo absorption of avobenzone at 3 above), and then took the skin from the the study’s design significantly limit the percent or higher under (or even static cell and subjected it to multiple conclusions that can be reached from its approaching) maximal usage conditions. rounds of tape stripping to assess the results. While we were able to locate a few presence of avobenzone at various levels Given that avobenzone’s chemical studies evaluating avobenzone’s of the skin. Following tape stripping, properties suggest that it has a potential absorption in vitro, these studies had a the skin was subjected to digestion (i.e., for transdermal absorption in sunscreen number of weaknesses that significantly the skin sample was subjected to a products, the lack of adequate data limited the conclusions that could be chemical treatment that breaks down assessing its absorption in realistic drawn from them. the cell membranes to release any sunscreen formulations is a concern. We The first in vitro study we located sunscreen that might be either bound to therefore expect that a MUsT evaluated the penetration—through proteins or bound up in the cells). demonstrating the degree of absorption excised human skin—of five sunscreen The study results showed significant of avobenzone into the human body ingredients (including avobenzone) that retention of avobenzone in the stratum under maximal use conditions will be had been diluted in mineral oil and corneum, a lesser amount in the needed to support a positive GRASE water (Ref. 100). The study used a static epidermis, and none in the dermis or determination for sunscreens containing cell technique. As discussed in section receptor fluid. Like the previous study, avobenzone. Further, in light of the VIII.D, in a static cell study, the test however, the test material used in this above-described data showing product (here, a sunscreen/mineral oil/ study did not include any of the avobenzone’s photoinstability, we also water formulation) is placed on the permeation enhancers typically expect that, if sufficient data are upper side of a membrane (here, the included in commercial sunscreen provided to support the safety of excised skin) in the open donor formulations. It is also unclear whether avobenzone, any future sunscreen chamber of a static cell, and a sampling sink conditions existed in the receptor monograph including avobenzone as an fluid is placed on the other side of the phase of the study. active ingredient will include the membrane in a receptor cell. Diffusion The final in vitro study used a static limitation that avobenzone is not of the ingredient (here the avobenzone) cell to evaluate the transdermal GRASE for use in sunscreen products from the topically applied product to penetration of six sunscreen unless it has been photostabilized (via and across the membrane is monitored formulations collected from a health spa use of a photostabilizing UV filter or by examining sequentially collected that marketed its own line of skin care other photostabilizing ingredient/ samples of the receptor fluid. To ensure products (Ref. 96). This study improved mechanism) to prevent its that all transdermal penetration of the on the design of the previous two photodegradation and (among other ingredient that takes place is fully studies in several respects. First, the concerns) the attendant reduction in reflected in the receptor fluid, the receptor fluid contained ethanol, a avobenzone efficacy. receptor fluid must be optimized for permeation enhancer often used in Because photodegradation can reduce absorption (in other words, sink sunscreen products, which produced the amount of avobenzone absorbed conditions must be created in the fluid). sink conditions in the receptor phase. transdermally, we also expect that a In this study, the use of skin as the Secondly, to create favorable conditions MUsT sufficient to support the general membrane in the system allowed for an for absorption, the products were recognition of safety of avobenzone for evaluation of the presence and depth of applied at a thickness of 20 mg/square sunscreen use would need to test permeation via skin stripping—the centimeters (cm2) on the skin’s surface formulations of avobenzone that include sequential application and removal of (i.e., 10 times the skin loading typically a photostabilizer. Including

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photostabilizers in MUsT formulations (including photosafety, irritation, or have targeted evidence to support the will allow for accurate assessment of sensitization studies) to be necessary to safety and effectiveness of avobenzone absorption levels in final formulated support the safety of this ingredient for when combined with the remaining sunscreen products containing sunscreen use at up to 5 percent. As is active ingredients. We believe this avobenzone. This proposal is consistent customary in clinical trials, however, limitation was inconsistent with the with our general recommendation that we recommend that dermal safety data approach to evaluating sunscreen materials evaluated under the MUsT for avobenzone be collected during combinations that the Agency has paradigm represent real-world MUsT studies. generally taken throughout the OTC sunscreen formulations, rather than n. Other nonclinical safety studies for Drug Review for sunscreens. For this overly simplified solutions that fail to avobenzone. Dermal carcinogenicity reason, unless evidence is submitted to replicate the absorption potential of studies have not been conducted for suggest that there is a safety or efficacy marketed formulations. As noted in avobenzone. The available data on the concern associated with the section VII.B.4, we encourage sunscreen permeation of avobenzone suggest that combination of avobenzone with manufacturers to discuss their MUsT it may permeate into at least the dermis another active ingredient, we expect to protocol with FDA before beginning the and epidermis, which means that it is conclude that a positive GRASE trial. possible for avobenzone to impact skin determination for avobenzone will m. Data supporting dermal safety of tumor development. We therefore support its use in sunscreens either avobenzone. The available clinical expect that dermal carcinogenicity alone or in combination with all other dermal studies indicate that avobenzone studies will be necessary to support a sunscreen active ingredients. at concentrations up to 5 percent have positive GRASE finding for sunscreens p. L’Oreal request to increase a favorable safety profile with respect to containing this ingredient. Available concentration of avobenzone to 5 potential irritation, sensitization, and embryofetal development studies in rats percent. Avobenzone is currently listed photosafety. In 2009, in conjunction and rabbits did not reveal any findings in the Stayed 1999 Final Monograph at with a citizen petition 36 (L’Oreal of concern. However, our review of the 38 concentrations up to 3 percent. As Petition, Docket No. FDA–1978–N– nonclinical data for avobenzone also described earlier, in 2009 FDA received 0018–0675) asking FDA to take action to revealed that toxicokinetic data a citizen petition from L’Oreal permit the marketing of sunscreen following repeat-dose exposure will be requesting, among other things, that we products containing avobenzone up to 5 needed to interpret pivotal nonclinical amend the sunscreen monograph to percent, L’Oreal USA Products, Inc. safety studies (including the increase the allowable level of (L’Oreal) submitted nine human repeat embryofetal development studies in rats avobenzone to 5 percent (L’Oreal insult patch, phototoxicity, and and rabbits) once the MUsT data Petition at 1). In the Stayed 1999 Final photoallergy studies with six different become available. (As explained in Monograph, the Agency determined that sunscreen formulations containing section VII.B.4, these data are used to avobenzone at concentrations up to 3 avobenzone (3.4 percent, 4 percent, or 5 compare drug levels achieved in animal percent is an effective sunscreen active percent). The studies showed that the studies with those observed in humans ingredient. We now likewise conclude formulations were well tolerated for under maximal exposure conditions.) In that the record contains sufficient topical use (i.e., essentially non- addition, if results of a MUsT information to satisfy the effectiveness allergenic, non-irritating, and non- demonstrate that there is significant prong of the GRASE standard for sensitizing, with mild to moderate systemic absorption of avobenzone, sunscreens containing avobenzone at reactions occurring only rarely) (L’Oreal additional fertility and early embryonic concentrations up to 5 percent. Petition).37 A separate search of the development and prenatal and postnatal available scientific literature on the development studies in rats will be As described above, data submitted clinical safety of avobenzone did not needed to support a positive GRASE with that L’Oreal Petition were reveal anything to undermine these finding. Depending on the results of the sufficient to establish that avobenzone findings. Although the available MUsT, systemic carcinogenicity studies at a concentration of up to 5 percent has literature included a small number of may also be needed. a favorable safety profile with respect to reports of contact irritation and o. Avobenzone in combination with potential irritation, sensitization, and photosensitization in connection with other sunscreen active ingredients. As photosafety. To support a finding that avobenzone-containing products, details noted in section III.B, our finding in the avobenzone at concentrations up to 5 about the composition of the Stayed 1999 Final Monograph that percent is GRASE for use in sunscreens, formulations at issue (and the avobenzone was GRASE for use in however, FDA expects that a MUsT concentrations of avobenzone) were sunscreens would have allowed its evaluating the transdermal absorption of frequently missing from the literature, combination only with certain other avobenzone up to 5 percent, as well as making it difficult to determine the sunscreen active ingredients (64 FR dermal carcinogenicity studies and cause of these responses. A small 27666 at 27688) because we did not toxicokinetic data for avobenzone at a number of serious hypersensitivity concentration of at least 5 percent, will reports for sunscreens containing 38 The available nonclinical data for avobenzone also be needed. Depending on the avobenzone were also located in include acute oral and dermal toxicity studies in outcome of the MUsT, we may also need rats; a 13-week oral toxicity study in rats; a 28-day systemic carcinogenicity data and FAERS. Because the sunscreens at issue dermal toxicity study in rats; a 21-day dermal usually contained three or more active toxicity study in rabbits; several in vitro additional DART studies, including ingredients, however, it is difficult to genotoxicity tests; an in vivo micronucleus test in fertility and early embryonic mice, as well as a sensitization test in guinea pigs; determine what caused the reaction. development, and pre- and postnatal a primary skin irritation test in rabbits; an ocular development studies in rats for Because sufficient data exist to make a irritation test in rabbits; a phototoxicity study in determination, we do not consider guinea pigs; a photoallergenicity study in guinea avobenzone at 5 percent. The record additional dermal clinical studies pigs; and embryofetal development studies in rats does not currently include any of these and rabbits (Givaudan-Roure Petition, Docket No. data. However, if FDA were to receive FDA–1978–N–0018–0751). Importantly, (except for 36 FDA–1978–N–0018–0675, two volume the embryofetal development studies) these studies sufficient data to support a positive submission (February 20, 2009) (L’Oreal Petition). are not sufficient to resolve safety concerns for a GRASE finding for avobenzone up to 5 37 Id., volume I, pp. 5–8. chronically used product. percent, we would expect to include

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avobenzone at this percentage in a final and we therefore expect that any future containing avobenzone. Depending on sunscreen monograph. sunscreen monograph including the outcome of a MUsT assessing the q. Conclusion. Given that: (1) avobenzone as an active ingredient will absorption of avobenzone, systemic Avobenzone’s organic solubility, include the limitation that avobenzone carcinogenicity testing and additional molecular weight, and melting point is not GRASE for use in sunscreen DART studies, including fertility and suggest it has a potential for transdermal products unless it has been early embryonic development and pre- absorption; (2) there is a lack of photostabilized to prevent its and postnatal development studies in available data on the transdermal photodegradation. In addition, we rats may be needed as well. We will also absorption of avobenzone in vivo believe that an adequate MUsT determine the extent to which (including under maximal use evaluating the absorption potential of additional DART studies may be needed conditions); and (3) there are limitations avobenzone will need to include a based on the results of the MUsT. in the available in vitro studies photostabilizer to ensure that the Depending on the results of the assessing avobenzone absorption, we potential transdermal absorption of expect that a properly designed MUsT avobenzone from avobenzone- nonclinical and pharmacology studies will be necessary to support a positive containing sunscreens is accurately for this ingredient and the safety margin GRASE finding for avobenzone use in assessed. that is calculated from these results, sunscreens. We expect that, to be We also expect that dermal pediatric studies for avobenzone may GRASE for sunscreen use, avobenzone carcinogenicity and toxicokinetic data also be needed to support the use of will need to be photostabilized to will be necessary to support a positive sunscreens containing avobenzone in address its potential for degradation, GRASE finding for sunscreens pediatric populations.

TABLE 4—SUMMARY OF RECOMMENDATIONS: STUDIES FOR AVOBENZONE UPTO3 (OR 5) PERCENT

Safety studies FDA proposes are necessary to support a GRASE determination Additional studies or data necessary?

Pharmacological Studies: Human absorption (MUsT) (including metabolite study in humans) Yes. Nonclinical Safety Studies: Toxicokinetics ...... Yes. Dermal Carcinogenicity ...... Yes. Systemic Carcinogenicity ...... Dependent on results of the MUsT. DART: Fertility and early embryonic development ...... Dependent on results of the MUsT. Embryofetal development in two species (rodent and non-rodent) .. No. Prenatal and postnatal development ...... Dependent on results of the MUsT. Clinical Safety Testing: Skin irritation and sensitization ...... No. Skin photoallergenicity and phototoxicity ...... No. Pediatric studies ...... Pediatric studies may be required depending on the outcome of the MUsT.

D. Anticipated Final Formulation In purposes of this proposed rule, we use final formulations, which we anticipate Vitro Permeation Testing the term final formulation testing to requiring in the future for sunscreen refer to testing conducted on the products marketed under the sunscreen As noted earlier, a final sunscreen sunscreen product formulation to be monograph (unless FDA determines that monograph will need to set out the marketed. Our expectation is that final the ingredient or ingredients contained conditions under which any product formulation testing would also generally in the product are unlikely to be marketed pursuant to it would be be necessary to ensure that the active absorbed through the skin). Because this GRASE and not misbranded. Variations ingredient in any given sunscreen testing would not be required for among individual sunscreen product formulation permitted under the sunscreens containing only those active formulations—in particular, monograph would not be systemically ingredients proposed here as Category I characteristics of the specific vehicle absorbed beyond the amount FDA (zinc oxide and titanium dioxide), FDA (e.g., the cream, lotion, or oil) in which determined to be safe. has not yet reached a final active ingredients are delivered—can The discussion that follows provides determination as to the particular affect the transdermal absorption of FDA’s thinking about such testing of parameters that might be required for sunscreens, and thus, have an impact on such final formulation testing. We their safety and effectiveness. To ingredients that are addressed in this rulemaking, anticipate that we may specify final address this, FDA currently requires for use in products marketed without approved formulation testing requirements in the NDAs. OTC sunscreens marketed under NDAs final formulation testing of OTC monograph in the future, however, as sunscreen products to support labeled provide similar information in their product- specific applications to substantiate their labeling. active ingredients that we are now claims regarding their effectiveness— For proposed changes to § 201.327, see codified proposing as Category III may be namely, testing for SPF value as well as section of this document. The Stayed 1999 Final included in the monograph in the future broad spectrum protection and water Monograph also required SPF testing of final if FDA receives data supporting their resistance where those attributes are formulations as a GRASE condition. Elsewhere in this proposed rule, we propose to establish GRASE status. Final formulation testing claimed in product labels.39 For monograph conditions in 21 CFR part 352 that requirements applicable to such ensure that all sunscreens are tested for SPF in ingredients would be established on an 39 See § 201.327 for the current labeling accordance with § 201.327(i) and achieve a requirements, and underlying testing, for OTC minimum SPF of 2, and that certain sunscreens ingredient-specific basis, taking into sunscreens containing one or more of the 16 active pass the broad spectrum test in § 201.327(j). consideration the data provided to

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support a positive GRASE diffusion cell is comprised of three conduct in vitro permeation testing to determination for the specific ingredient major units: (1) An upper chamber (into establish that the reformulated product (for example, whether any safety signals which the sunscreen formulation is satisfies the final formulation in vitro are detected in well-conducted placed); (2) the rate-limiting membrane permeation testing requirements set out nonclinical carcinogenicity and DART (the prepared human skin); (3) and the in the sunscreen monograph or (2) seek studies). We encourage interested lower chamber/fluid channel NDA approval for the new formulation. parties to provide information and (containing a receptor fluid that is comment for each sunscreen active evaluated to determine how much of the IX. Additional Proposed Conditions of ingredient that is relevant to sunscreen it ‘‘receives’’) (Refs. 145 to Use establishing this kind of final 147). The vertical diffusion cell system A. Proposed Requirements Related to formulation testing for each active has been commercialized and is Dosage Form ingredient. available as both single and multiple OTC sunscreens have been marketed FDA’s expectation is that this testing unit models that can be automated. in a variety of dosage forms over the would not generally call for an in vivo Other relevant parameters FDA study. Instead, FDA expects that the expects to consider in establishing years. Responding in part to the growing conditions of marketing specified for future requirements for in vitro market acceptance of spray sunscreens, sunscreens containing a given active permeation testing include (among other on June 17, 2011, FDA issued an ANPR ingredient would require manufacturers things) the thickness and integrity of addressing sunscreen dosage forms to perform in vitro permeation testing collected skin, storage conditions used (Dosage Forms ANPR) (76 FR 35669, before marketing each sunscreen for collected skin, receptor fluid June 17, 2011). The ANPR identified formulation containing that ingredient. composition, skin and receptor fluid dosage forms considered eligible or Consistent with the approach for SPF temperature, the number of skin ineligible for review and potential and broad spectrum final formulation samples (and donors) used, study inclusion in the OTC sunscreen testing set forth in § 201.327 (for duration, sampling period, application monograph, based on FDA’s knowledge, proposed changes to § 201.327, see method, and number of experimenters. at that time, of their history of marketing codified section of this document), FDA We note that if a final sunscreen before the OTC Drug Review began in anticipates that it would not review the formulation contains a combination of 1972. It also solicited specific results of the in vitro permeation testing sunscreen active ingredients, FDA information about the safety, before product marketing. Rather, FDA anticipates requiring that this final effectiveness, and directions for use of expects that any future conditions formulation be tested against the spray sunscreens. pertaining to final formulation in vitro standard control formulations for each 1. Summary of Eligible and Ineligible permeation testing in the sunscreen of the sunscreen active ingredients it Dosage Forms monograph would include a contains. As noted above, a standard requirement that manufacturers control formulation might not be In this proposed rule, FDA is maintain records of this testing, and that specified for (and final formulation in confirming that the following dosage those records be available for FDA vitro permeation testing might not be forms identified in the Dosage Forms inspection upon request. necessary to establish safety for) a ANPR are eligible for review and FDA anticipates establishing a sunscreen containing a particular active potential inclusion in the OTC standard control formulation for each ingredient if FDA determines that the sunscreen monograph based on their sunscreen active ingredient to be used ingredient is unlikely to be absorbed history of sunscreen marketing before in the in vitro permeation testing of through the skin. As mentioned above, 1972: Oil, lotion, cream, gel, butter, products containing that ingredient. The we therefore do not propose to require paste, ointment, stick, spray, and standard control formulation would be final formulation in vitro permeation powder. With the exception of powder, the formulation that produces the testing for sunscreen formulations FDA proposes that sunscreens in these highest in vivo absorption in the MUsT. containing only zinc oxide and/or dosage forms are GRASE subject to The results of in vitro permeation titanium dioxide. certain conditions described below and testing using this control formulation In cases in which such testing is elsewhere in this proposed rule. We would then be used as a bridge to a required, FDA anticipates that if the in note that sunscreen powders were corresponding level of in vivo vitro permeation of each sunscreen classified as ineligible for review in the absorption from the MUsT that is used active ingredient in the final formulated Dosage Forms ANPR because, at that to establish the safety margin for the product is equal to or less than the value time, we were unable to identify any ingredient. Then, FDA anticipates obtained from in vitro permeation sunscreen products in powder form that establishing conditions to ensure that testing of the standard control were marketed before the OTC Drug final formulation in vitro permeation formulation for that active ingredient, Review began. Based on marketing data testing would be conducted for each the product’s safety margin would be submitted to the ANPR docket and in a formulation intended to be marketed, considered to fall within the parameters related citizen petition (Docket No. using the specified vertical diffusion judged to be GRASE, and thus to 1978–N–0018–0741), we have cell described below. The results of the support marketing of the formulation. determined that the powder dosage form in vitro permeation testing of each final However, if the in vitro permeation of is eligible to be considered for inclusion formulation would be compared to the the active ingredient from the specific in the OTC sunscreen monograph. absorption found in the standard control final formulation is greater than the However, as described in section IX.A.4, formulation for the active ingredient it value obtained from in vitro permeation we tentatively conclude that additional contains. testing of the standard control safety and efficacy data will be In vitro permeation testing is a formulation for that active ingredient, necessary to classify sunscreens in the methodology that has been used in FDA anticipates that the drug product(s) powder dosage form as GRASE and dermal formulation development for using that formulation would not be include them in the final monograph. over 30 years and, as used here, considered GRASE. In that situation, the We are proposing that sunscreens in all specifically refers to use of the ‘‘Vertical sponsor would have the option to either: dosage forms other than those identified Diffusion Cell’’ (Ref. 144). A vertical (1) Reformulate the product and as eligible for consideration above—

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including wipes, towelettes, body fine droplets or particles. In some spray to compare directly, but—taken washes, and shampoos—are new drugs products, the sunscreen formulation is together—they suggest a high degree of because we did not receive data mixed in a canister with a liquefied gas uniformity between sprays and lotions showing that they were marketed prior propellant that supplies the force to in coverage of exposed skin, as well as to 1972. generate an aerosol containing both between different spray application dissolved sunscreen formulation and scenarios such as spraying directly on 2. Overview of Comments on the Dosage propellant upon activation of a valve skin or spraying followed by rubbing. Forms ANPR system. There are also pump spray Information submitted indicated that FDA received a total of 14 comments sunscreen products that are not the amount of spray sunscreen on the Dosage Forms ANPR. Six of the packaged under pressure but generate dispensed is higher than the amount comments provided no new data, but spray by applied mechanical force dispensed for sunscreen lotions, and generally supported the advantages of without the need for a propellant. Many that consumers are more likely to spray sunscreens, agreed with the need currently marketed spray sunscreen reapply sprays than lotions. There was to address concerns about spray products use a delivery technology no response from any stakeholder sunscreens’ performance and/or safety referred to as a bag-on-valve system, in regarding consumers’ compliance with (especially when used on children), which the sunscreen formulation is directions to rub a spray sunscreen into opined that existing SPF methods contained in a bag with an attached the skin. However, data was provided would not need to be modified for valve inside a canister filled with suggesting that rubbing spray sprays, or (in most cases) agreed with propellant, so as not to mix the sunscreens into the skin did not FDA’s suggested directions for use. sunscreen formulation and propellant enhance effectiveness. Based on these Other comments argued for the ingredients. For purposes of this comments and the available data, we are inclusion of additional dosage forms document, a spray sunscreen product is not proposing to require that labeling identified as ineligible in the Dosage one discharged from either a provide instructions to rub spray Forms ANPR, but failed to provide pressurized or nonpressurized sunscreens into the skin. supporting marketing data. One container, with the understanding that Comments on the Dosage Forms comment contained marketing the degree of atomization will likely ANPR also agreed, and we concur, that information showing that sunscreen vary according to the formulation, the the current FDA-required SPF and broad products in powder form, which we had container system used, and the design of spectrum tests are appropriate for previously identified as ineligible for the spray actuator, among other factors. evaluating the efficacy of sunscreens in the monograph, had been marketed in b. Spray sunscreen performance and spray dosage forms. SPF testing requires the United States before 1972. The effectiveness. The Dosage Form ANPR application of a set amount of sunscreen remaining comments (all from industry) asked a series of questions relating to (2 mg/cm2 on each test subject), which provided data and information that the performance and effectiveness of can readily be done for spray sunscreen directly or indirectly addressed spray sunscreens, including questions formulations. For example, comments questions raised in the Dosage Forms about the amount of spray sunscreen on the Dosage Form ANPR stated that ANPR concerning the safety, typically applied by consumers, the SPF testing of sunscreen spray effectiveness, and labeling of spray uniformity of coverage, how frequently products can be conducted following sunscreens. These comments are consumers reapply spray sunscreens, the method described in the current rule discussed in sections IX.A.3 and IX.A.4 whether consumers rub spray by weighing out the liquid form and below. sunscreens into the skin when directed applying it to the skin. This premise is 3. Safety and Effectiveness of Spray to do so and the resulting effect on supported by data from SPF testing Sunscreens effectiveness, and whether—and if so, submitted in the comments. For how—the SPF and/or broad spectrum example, one comment submitted five As we recognized in the Dosage tests need to be modified to address SPF testing reports conducted on sprays Forms ANPR, compared to traditional sunscreen sprays. The Dosage Forms using the FDA-required methods, in lotions, oils, and the like, spray ANPR also solicited studies comparing which the expected SPF values for the sunscreens raise potential concerns of spray sunscreens to other eligible test formulations were almost identical both safety and efficacy that FDA must dosage forms to see whether the dosage to the SPF testing results. The same consider in determining whether forms are comparable. logic applies to broad spectrum testing, sunscreens in the spray dosage form Four comments provided data from which also uses a defined amount of would be GRASE. With respect to multiple studies examining and sunscreen by weight. Based on this efficacy, FDA must consider factors comparing the performance of spray and information, we conclude that the such as whether spraying sunscreen lotion sunscreens on a variety of current and proposed SPF and broad rather than applying it by hand provides parameters, including amounts applied, spectrum testing methods are also effective coverage on exposed skin, how uniformity of coverage as measured appropriate for spray dosage forms. consumers use spray products, and with UV filter photography, c. Spray sunscreen safety. FDA has whether current test methods for SPF comparative SPF results, and consumer identified two primary safety concerns and broad spectrum protection can be ratings of ease and effectiveness of specific to spray sunscreen dosage relied on for adequate labeling of spray application, among others. FDA’s forms: (1) The potential risk of products. With respect to safety, spray evaluation of the information submitted respiratory harm from inhaling sunscreens raise the question of indicated that key questions asked in sunscreen ingredients and (2) the potential harm from inhalation of the Dosage Forms ANPR were directly potential flammability risk when sunscreen components as well as or indirectly addressed by these studies. consumers are exposed to flame or heat potential flammability risks. These studies indicated that consumers before spray solvents have completely a. Characteristics of sunscreen spray like the convenience of spray dried. For the reasons described below, products. Spray sunscreens use varying sunscreens and adapt their use of these we believe that both potential risks can technologies to package and deliver a products to achieve effective coverage. be acceptably mitigated by proposed sunscreen formulation as an aerosol Data provided on application uniformity formulation limitations, labeling spray, i.e., an airborne suspension of lacked study reports and were difficult requirements, and adequate testing, and

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thus propose to establish these as while only particles smaller than 4 mm information in the record to support a additional conditions in the monograph reach the unciliated airways and positive finding about their safety. We to ensure that sunscreen products in a alveolar region of the lungs (see believe that, taken together, these two spray dosage form would be GRASE. generally Refs. 148 to 153). Thus, limitations would significantly reduce d. Inhalational toxicity. Broadly although there are little or no data on inhalation risk from spray sunscreens by speaking, the human respiratory system the potential inhalation toxicity of reducing particle exposure to the larynx consists of the upper respiratory tract particular spray sunscreen ingredients, and deeper lung tissues. The particle (i.e., the airways of the nose to the we are proposing that exposure to size data submitted in response to the larynx) and lower respiratory tract (the harmful levels of such ingredients can Dosage Forms ANPR also suggest that trachea and branching airways of the effectively be minimized by imposing these limitations would be readily lung, including bronchi, bronchioles, particle size limitations on spray achievable without unduly burdening and alveoli) (see generally Refs. 148 and sunscreen products. sunscreen spray manufacturers. 149). Much of the respiratory system is Several comments on the Dosage With the establishment of these two lined with a layer consisting of mucus Forms ANPR submitted results of limits, FDA believes that the risks of cells and cilia that mechanically propel particle size distribution testing using adverse events related to unintentional inhaled particles out of the lower available methods and apparatus, with inhalation of spray sunscreens will be respiratory tract toward the mouth, the aim of showing that exposure to minimal. Stakeholders asserted that the where they may be swallowed or inhaled sunscreen products or risk of inhalation toxicity is already low, expectorated (Refs. 148 and 149). The ingredients would be minimal and thus primarily based on particle size of most significant concern associated with unlikely to cause adverse effects. The marketed sprays. Limited data on any product that may be accidentally data submitted were similar and in adverse event reports and animal inhaled is the potential risk of adverse some cases overlapping. In an analysis toxicity studies were also submitted in effects associated with deep lung of pooled particle size distribution data a few comments on the Dosage Forms deposition, which occurs when particles from all submissions, representing 50 ANPR, but were inadequate to support in an aerosol (i.e., a suspension of U.S.-marketed spray sunscreen the safety of spray sunscreens in the airborne particles such as a sunscreen products, 32 had particles smaller than absence of particle size limitations. If spray) reach the unciliated airways in 4 mm in diameter and thus within the the particle size limitations proposed the lung. Particles that can reach the respirable portion of the total particle here are adopted, however, we do not unciliated airways of the deep lung are size distribution. However, the great believe that additional animal toxicity described as respirable and may be majority of the particle sizes observed or other safety data need to be provided associated with serious adverse effects were nonrespirable. The highest to support a GRASE finding for spray such as asthma, emphysema, percentage that any product had of sunscreens. bronchospasm, or chronic obstructive particles smaller than 4 mm in diameter We are proposing that particle size pulmonary disease; particles that do not was 0.43 percent and the mean was 0.22 testing to demonstrate compliance with reach the deep lung may be associated percent, which is extremely low. the proposed limitations must be with less harmful adverse events such In addition to reviewing information conducted on spray products as they are as local irritation of the upper airway, from comments on the Dosage Forms dispensed from the consumer container coughing, or sneezing (Refs. 149 to 151). ANPR, FDA conducted its own analysis as part of the lot release testing that The potential health risk associated of particle size distribution for 14 would be routinely completed as part of with inhalation of hazardous aerosols marketed spray sunscreens. In those current good manufacturing practice depends on how much of a toxic tests, no sunscreen had more than 10 (CGMP) compliance under part 211 (21 substance is deposited in a given region percent of particles in sizes less than 10 CFR part 211). It is necessary to test the of the respiratory tract and how much mm in diameter and only three had size of particles dispensed from the remains after physiological clearance particles smaller than 5 mm (Ref. 154). consumer container to ensure that occurs through mechanisms such as To limit the risks of unintentional particle size requirements are met under coughing, sneezing, mechanical exposure and potential associated conditions of use by consumers. transport, or, in the deep lung, adverse events to respirable particles in For purposes of these proposed engulfment by specialized cells or other spray sunscreens, we are proposing particle size requirements, we are using protective action (Refs. 148 and 152). limits on the size of particles dispensed the term particle size broadly to mean The pathogenic potential of inhaled from the consumer container for the discrete unit emitted from the spray aerosols depends on where in the finished spray sunscreens in order for container that is available for inhalation respiratory tract a particle is deposited those products to be GRASE. We by a consumer when the product is (Ref. 152). Whether spray particles that propose that 90 percent of the particles applied. If the particle dispensed from enter the body through inhalation at the dispensed from the consumer container the consumer container is a droplet that nose or mouth will be deposited in the must be at least 10 mm or greater in meets the size requirements, the lung depends largely on their physical order to limit exposure beyond the consumer will not accidentally inhale it characteristics: Most notably particle larynx, and to prevent deposition in the into the deep lung. However, if that size, with the likelihood of respirability deep lung, the minimum particle size same droplet breaks apart into smaller increasing as particle size decreases dispensed from the consumer container fractions when it is dispensed from the (Refs. 148 to 153). The effects of particle must be no less than 5 mm. This limit consumer container, those fractions size on respirability of inhaled particles was chosen because it is the lowest would be the particles that must meet is well studied. There is general whole number above the generally the size requirement to ensure that agreement that particles greater than 10 accepted threshold (4 mm) at which consumers will not inadvertently inhale micrometers (mm) in diameter may enter particles enter the unciliated airway and them past the larynx. the mouth and the airway up to the because it allows for experimental error We are not proposing a specific test larynx. Approximately 50 percent of that may be inherent in particle size methodology for spray sunscreen particles up to 10 mm in diameter can measurements. Sunscreen products that particle size. Rather, sunscreen penetrate beyond the larynx to the do not meet both limitations would not manufacturers would be obligated to thoracic region of the respiratory tract, be GRASE because there is not sufficient ensure that particle size testing for their

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sunscreen sprays would be conducted e. Flammability risk. In July 2013, regulating and labeling sunscreens: (1) on each lot of the final product as FDA issued a Consumer Update Extremely flammable, (2) flammable, dispensed from the consumer container regarding persons catching on fire while and (3) combustible. These definitions in accordance with adequate written wearing spray sunscreen products near refer to flash point testing to be specifications. USP General Chapter 601 an open flame: performed using the method described part B provides methodology and The Food and Drug Administration (FDA) in 16 CFR 1500.43a. These definitions requirements for sprays, aerosols, and has become aware of five separate incidents are analogous to certain CPSC powders that include methodology to in which people wearing sunscreen spray definitions located at 16 CFR 1500.3. determine droplet/particle size near sources of flame suffered significant Given the conditions under which distribution, and we expect to consider burns that required medical treatment. The sunscreens may be used, we are testing done in accordance with the USP specific products reported to have been used proposing that spray sunscreens found as adequate to meet this proposed in these cases were voluntarily recalled from to meet the definition of extremely requirement (Ref. 155). the market, so should no longer be on store flammable in proposed § 352.3(f) are not shelves.... In the five incidents reported to We note that several comments on the GRASE and may not be marketed under FDA, however, the burns occurred after the the OTC sunscreen monograph. Dosage Forms ANPR expressed concern sunscreen spray had been applied. The about the potential inhalation risk from ignition sources were varied and involved Products found to meet the definition of exposure to spray sunscreens that lighting a cigarette, standing too close to a lit flammable or combustible in proposed contain nanomaterials (as both active citronella candle, approaching a grill, and in § 352.3(g) or (h) would be required to and inactive ingredients). One comment one case, doing some welding (Ref. 156). include the following language in the ‘‘Warnings’’ section of the drug facts also recommended that FDA require the These cases all involved a single labeling: [bullet] ‘‘Flammable’’ or presence of such ingredients to be manufacturer’s product that has since ‘‘Combustible’’ [as applicable] followed disclosed on spray sunscreen labels. been voluntarily recalled. Review of by a colon and the statement ‘‘Keep FDA’s approach to nanotechnology and adverse event reports since the away from fire or flame’’. nanomaterials in sunscreen products is voluntary recall of this product discussed in section VII.E. FDA is not A further concern related to indicates that no additional cases flammability is the time required for now proposing conditions of use, involving spray sunscreens have been including labeling, for spray sunscreens volatile solvents in a spray product to reported. However, sunscreens are often dry on the skin before a consumer can that distinguish based on the presence used in very hot outdoor environments of nanomaterials because we are safely approach a source of heat or with high ambient air temperatures. flame or can smoke without danger of proposing that any sunscreen spray that Sunscreens are also frequently used contains any particles smaller than 5 mm fire. Typical sunscreen spray around sources of flame or sparks, such formulations contain 50 to 80 percent of when it is dispensed from the consumer as grills, bonfires, smoking, or other container would not be GRASE. With a volatile carrier, most commonly ethyl ignition sources. To ensure safe use of alcohol. These volatile solvents are respect to nanomaterials in spray spray sunscreens and to better inform sunscreens, we note that the primary necessary to the formulation to allow consumers about potential flammability the product to be sprayed onto the skin. determinant of inhalation risk is the size risks, we are proposing to limit the After spraying, the solvents are intended of the particles in emitted sprays, which flammability and require flammability to rapidly evaporate leaving a film of may be larger than individual labeling of spray sunscreens under the UV filters on the skin surface as the formulation components. Nanoscale OTC sunscreen monograph. product dries. Once a spray product is ingredients would not pass the particle FDA’s general labeling regulations for dry, the solvent is no longer present so size limitations for spray sunscreens; OTC drugs provide for OTC monographs the flammability risk is low. However, therefore, if they were to be detected to require flammability labeling in prior to this point, the flammability risk when sprayed from the consumer suitable cases (§ 201.66(c)(5)(ii)(C)) (21 would be higher. container during particle size testing, CFR 201.66(c)(5)(ii)(C))), and we have We think that consumers should be the sunscreen could not be marketed done so for products such as topical warned to stay away from sources of under the OTC monograph. antitussives (21 CFR 341.74) and wart flame while a flammable or combustible In addition to the proposed removers (21 CFR 358.150). As we did sunscreen spray dries. For this reason, limitations on particle size for for those products, we are proposing to we propose to require that each batch of sunscreen sprays and related testing, we require each spray sunscreen a sunscreen spray product that meets are proposing to require that the formulation to be labeled for the definition of flammable or following labeling be included in the flammability in accordance with the combustible at § 352.3(g) or (h) be tested directions for sunscreen sprays to testing methodology described in a for drying time in accordance with minimize unintended inhalation: regulatory provision issued by the written specifications. If the drying time • Hold container 4 to 6 inches from Consumer Product Safety Commission is less than 5 minutes, we propose to skin to apply. (CPSC) (see 16 CFR 1500.43a). We have require that the labeling state, ‘‘Wait 5 • Do not spray directly into face. proposed to incorporate this flash point minutes after application before Spray on hands then apply to face. testing methodology to address our approaching a source of heat or flame, • Do not apply in windy conditions. concern regarding the flammability of or before smoking.’’ If the drying time is • Use in a well-ventilated area and sunscreen in the spray dosage form after at least 5 minutes but less than 10 avoid inhalation. it has been dispensed onto the skin. We minutes, we propose that the labeling This language is the same as that therefore propose that all batches of would state, ‘‘Wait 10 minutes after published in the Dosage Forms ANPR. sunscreen spray products be tested for application before approaching a source Its adoption was supported by flammability in accordance with 16 CFR of heat or flame, or before smoking.’’ We comments on the Dosage Forms ANPR, 1500.43a as part of batch release testing propose that a sunscreen spray that is and the language is widely used on conducted in accordance with CGMP flammable or combustible and that takes currently marketed spray sunscreens requirements. 10 minutes or more to dry would not be consistent with the 2018 Final We are also proposing to define three GRASE because of the possibility of Guidance. flammability categories for use in consumers approaching sources of fire

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during such an extended drying period. • How frequently do consumers to SPF 50+ (76 FR 35672, June 17, We invite comment on this approach. reapply the product? 2011). • Does rubbing a powder into the skin In the time since these 2011 4. Powder Dosage Forms change sunscreen effectiveness? publications, the body of evidence in Although we have found powder • Are powder dosage forms water- the published literature on UVA sunscreens to be eligible for resistant? If they are not water-resistant, radiation (particularly UVA I radiation) consideration in the OTC sunscreen is a direction to reapply every 2 hours and its role in the development of skin rulemaking, we have tentatively sufficient to assure their safe and cancer has grown. This new data about determined that additional data as effective use? the harms of UVA exposure is a outlined below will be needed to • Can the powder dosage form be significant concern given, among other support a conclusion that sunscreens in used safely and effectively over all areas things, that with currently available this dosage form are GRASE and to of skin exposed to the sun, or should sunscreens, consumers may support consideration of appropriate this dosage form be limited to the face? unknowingly accumulate excessively labeling. Also, like sprays, powder • What factors, if any, should FDA large UVA doses by using sunscreens sunscreens pose the potential for consider in connection with particle with high SPF values that either: (1) Do unintended inhalation, and for this size limitations or test methods for not pass FDA’s current critical reason, if admitted to the sunscreen sunscreen powders? wavelength-based broad spectrum test monograph, the same limitations as to • Are there important differences or (2) have inadequate uniformity in particle size here proposed for sprays among powder types (e.g., loose, their UVA protection. Because of these would be expected to apply. For powder compact) or applicators that would concerns, we are making a number of sunscreens that meet the particle size affect particle size testing? proposals designed, among other things, limitations proposed for sprays, we do to couple a greater magnitude of UVA FDA will evaluate data and information protection to increases in SPF values. not expect that additional toxicology submitted in response to these data would be needed to address the questions, as well as any other 1. Background potential health risks associated with submitted or available data, to UV radiation includes both UVA and inhalation. determine whether additional data are UVB rays. UVB rays (i.e., those with One comment on the Dosage Forms needed to support a final GRASE wavelengths from 290 to 320 nm) are ANPR provided data on SPF and broad determination for this dosage form. higher energy, are much more effective spectrum performance of five powder at producing sunburn, and produce formulations, as well as data from B. Proposed Maximum SPF and Broad Spectrum Requirements greater amounts of cellular damage repeated insult patch tests and (including DNA lesions, which can photosensitivity studies that were In the Stayed 1999 Final Monograph, result in gene mutations linked to skin asserted not to show any safety issues. FDA established SPF 30+ as the cancers) (Refs. 157 and 158). UVA rays FDA has conducted particle distribution maximum labeled SPF value for (i.e., those with wavelengths from 320 to testing on five powder sunscreens. The sunscreen monograph products, and 400 nm) are lower energy and less powder sunscreens tested had a larger required that each sunscreen effective at producing sunburn, but proportion of relatively small particles monograph active ingredient contribute make up the majority of UV radiation, compared to the sprays. Only one of the a minimum SPF of 2 to finished and penetrate much deeper into the five powder sunscreens would have sunscreen products (64 FR 27666 at skin, potentially causing oxidative complied with the requirement we are 27672, 27674 and 27675). The final damage (through formation of ROS) to considering that no more than 10 monograph did not include any broad skin pigment cells (Ref. 159). UVA rays percent of the particles could be smaller spectrum protection provisions. In its also contribute to photo-aging (Ref. 157 than 10 mm in diameter, and that 2001 decision to stay the final and 160). Although the current product was also the only one that monograph, however, FDA indicated scientific literature attributes UV- would have met the prospective that it was issuing the stay because the signature DNA lesions primarily to UVB limitation of no particles smaller than 5 Agency intended to amend the wavelengths, UVA wavelengths can also mm in diameter (Refs. 153 and 154). sunscreen monograph to address produce DNA lesions. Although UVA Based on the data submitted, we believe requirements for both UVA and UVB wavelengths produce DNA lesions to a that (current and proposed) SPF and radiation protection (66 FR 67485). FDA significantly lesser degree than UVB broad spectrum test methods are later addressed these issues in the 2011 wavelengths do, DNA lesions produced appropriate for use with powder L&E Final Rule, which, among other by UVA rays have been reported to have sunscreens, and we are not requesting things: (1) Established optional broad slower repair rates (Ref. 157). UVA rays additional respiratory safety information spectrum labeling based on satisfaction are comprised of UVA I rays (340 to 400 for powders that meet the same particle of a critical wavelength test, (2) created nm) and UVA II rays (320 to 340 nm). size limitations proposed for spray an optional indication relating to skin As discussed below, until recently, UVA sunscreens. cancer and early skin aging risk I rays were generally not considered to FDA invites comments and data on reduction for broad spectrum products contribute significantly to the harms the following topics related to powder with an SPF of 15 or higher, and (3) associated with UV exposure. sunscreens: required a labeling warning for Sunscreen products must be labeled • What amounts of powder sunscreens that did not both satisfy the with an SPF value calculated using a sunscreens do consumers typically broad spectrum test and provide an SPF standardized SPF testing procedure set dispense? of at least 15 (76 FR 35620 at 35626– forth in FDA regulations (see • What amounts of powder 35628) (L&E Final Rule). Concurrently § 201.327(i)). ISO 17166 CIE S 007/E sunscreens are effectively transferred to with publication of the L&E Final Rule, was approved for incorporation by the skin? FDA issued a proposed rule to raise the reference into § 201.327(i) as of June 18, • How uniform is the sunscreen maximum labeled SPF value for 2012 (76 FR 35619, June 17, 2011). The application across the sun-exposed area sunscreen products containing SPF test measures the amount of UV of the skin? sunscreen monograph active ingredients radiation exposure it takes to cause

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sunburn when a person is using a less efficient DNA lesion repair in the couple a greater magnitude of UVA sunscreen compared with how much basal layer (Refs. 166 and 167). protection to increases in SPF values. UV exposure it takes to cause sunburn Damage to cells in the basal layer (if As discussed in further detail below, we when the person is not using a left unrepaired or if inefficiently are also making proposals designed to sunscreen. Sunscreens with increasing repaired) can lead to mutations in address evidence of variability in SPF SPF values (up to a certain point) have critical genes that increase the values and evidence showing additional been demonstrated to provide increased possibility that normal cells will clinical benefits associated with SPF 60 sunburn protection. Because SPF values transform into cancer cells. While sunscreens. represent a sunscreen’s level of sunburn inefficient DNA repair is a concern for protection, they are primarily (though all individuals exposed to UV radiation, 3. Broad Spectrum Proposals this concern is particularly acute in not exclusively) an indicator of a. UVA I/UV ratio required to pass the those with xeroderma pigmentosum (a expected protection from UVB broad spectrum test. We are proposing disease caused by a disorder of the DNA radiation. To pass FDA’s current test for certain changes to the requirements to broad spectrum labeling (§ 201.327(j)), repair system), who have extreme sensitivity to UV radiation, and who pass the broad spectrum test. however, sunscreens must demonstrate Specifically, we are proposing to add to that, in addition to UVB protection, they develop both nonmelanoma skin cancer the current broad spectrum test a also provide some UVA protection. and melanoma with a high frequency and very early in life (Ref. 168). In requirement that products meet a UVA Only products that have been addition to the skin cancer-related risks I/UV ratio of 0.7 or higher. We note that determined to have a minimum SPF associated with UVA exposure, the current broad spectrum test value of 15 and to pass our broad 40 increasing evidence shows that UVA I procedure would remain unchanged spectrum test may include statements in radiation also produces and that this new ratio would be their labeling indicating that they immunosuppression (Refs. 169 and calculated using data from the existing decrease the risk of skin cancer and 170). This, too, is a general concern for test, which should help minimize early skin aging caused by the sun when all individuals, but is especially burden on manufacturers. used as directed with other sun dangerous for certain at-risk populations protection measures (§ 201.327(c)(2)). In The current labeling regulation (such as organ transplant recipients and contrast, sunscreens that have not been requires that sunscreens labeled as others on immunosuppressive drugs). broad spectrum achieve a critical determined to provide both broad Given the above-described evidence, spectrum protection and an SPF value wavelength of 370 nm or greater we are concerned about the existing (§ 201.327(j)). A sunscreen product’s UV of at least 15 must include a skin potential for inadequate UVA protection cancer/skin aging alert warning to protection is often displayed as a curve in marketed sunscreen products. This is on a graph showing the amount of UV consumers that ‘‘[s]pending time in the a particular concern with respect to high sun increases your risk of skin cancer absorbance the product provides at each SPF sunscreen products that do not pass wavelength in the UV spectrum (i.e., and early skin aging’’ and that ‘‘[t]his FDA’s current critical wavelength-based product has been shown only to help from 290 to 400 nm). The ‘‘critical broad spectrum test or that (though they wavelength’’ of the product is the prevent sunburn, not skin cancer or pass our current broad spectrum test) early skin aging’’ (§ 201.327(d)(2)). wavelength corresponding to 90 percent have inadequate uniformity in their of the area under this curve. Higher 2. Increased Evidence of Harms UVA protection. Consumers using these critical wavelengths, therefore, illustrate Associated With Exposure to UVA products may, while successfully greater breadths of UV protection across Radiation preventing sunburn, accumulate the 290 to 400 nm spectrum. excessively large doses of UVA Since publication of the 2011 L&E radiation, thereby exposing themselves Most sunscreen products—even if Final Rule and Max SPF PR, the to additional risks related to skin cancer they achieve a critical wavelength of strength of scientific evidence linking and early skin aging. The International 370 nm or greater and therefore meet the UVA exposure to skin cancers and other Agency for Research on Cancer has current criteria for broad spectrum harms has increased. This evidence found that high SPF sunscreen products labeling—have historically covered the suggests that UVA wavelengths are associated with longer intentional UVB and UVA II ranges preferentially. continue generating DNA lesions hours UV exposures (Ref. 171), raising the Given how much of the UVA portion of after UV exposure (Ref. 161) and that if concern that use of these products may the UV spectrum is composed of UVA left unrepaired, these DNA lesions can result in significant doses of UVA I radiation (see Figure 3 below) and form UV-induced mutations in many radiation. We note that concerns given what we now know about the genes that have been detected in both relating to inadequate UVA protection risks associated with UVA exposure, melanoma and nonmelanoma skin came up in several comments we and with UVA I exposure in particular, cancers (Refs. 162 to 165). Further, received in response to the 2011 Max ensuring that sunscreen products unlike UVB-induced DNA lesions, SPF PR, and that these comments raised provide adequate protection in the UVA which attenuate with skin depth, recent particular concerns about inadequate I portion of the spectrum is critical. evidence indicates that DNA lesions UVA protection in high SPF products. induced by UVA I exposure show the This concern has also grown over time 40 We note that, as described in section IX.D.2.i, opposite pattern, with both increased in the published literature (Refs. 172 to we are proposing a minor revision in equipment specifications for the broad spectrum test to DNA lesions in the basal layer of the 175). respond to feedback that FDA received on this issue epidermis (where melanocytes and For all of these reasons, we are and proposing some minor revisions to current proliferating keratinocytes reside) and proposing a number of steps designed to language to make clear our existing expectations.

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We are therefore proposing to require particular combination of active indicating that ‘‘[t]he proposed ratio that in order to pass the broad spectrum ingredients used in the product and places too much emphasis on the UVA test, a product must demonstrate that it which parts of the UV spectrum they I region, which is not generally provides a UVA I/UV ratio of 0.7 or absorb). For example, under the current considered to contribute significantly to higher, indicating that the product testing regime, a sunscreen that is the harmful effects of exposure to UV provides a minimum measure of UVA I labeled ‘‘broad spectrum SPF 30’’ could radiation’’ (76 FR 35620 at 35650), we radiation absorbance relative to total UV provide less UVA protection than a made a number of changes to our 2007 radiation (i.e., UVB + UVA) absorbance, sunscreen labeled ‘‘broad spectrum SPF proposal in the 2011 L&E Final Rule. in addition satisfying to the 370 nm 15.’’ Those changes included elimination of critical wavelength requirement. We note that FDA first raised the UVA I/UV ratio and adoption of the Requiring a UVA I/UV ratio of 0.7 or concerns relating to the adequacy of above-described critical wavelength test higher for broad spectrum products UVA protection in sunscreen products for establishing broad spectrum would mean that these products would in 2007 (see 72 FR 49070 at 49104 to protection instead. As we noted in the have a more uniform amount of 49107). At that time, we proposed a preamble to the L&E Final Rule, our radiation protection across the UVA I, similar ratio to the one we are proposing decision not to require the UVA I/UV UVA II, and UVB ranges. This improved today as part of a different, more ratio at that time was based, in part, on fidelity across the UV spectrum is complex proposal for testing and our agreement with comments stating especially important for high SPF labeling to address broad spectrum that the scientific evidence available at products which, as discussed above, are protection that, among other things, that time indicated that UVA I exposure associated with longer intentional sun included both in vitro did not pose sufficient risk of harm to exposure, which in turn can result in (spectrophotometric) and in vivo justify the emphasis placed on it by the significant doses of UVA radiation. This (clinical) testing for UVA radiation, as ratio, and that the critical wavelength proposed UVA I/UV ratio would also well as a four-tier UVA star rating test provided a superior measure of help eliminate the current potential for labeling system. In response to broad spectrum protection (id. at a product labeled as broad spectrum comments describing purported 35650). that has a higher SPF value to provide disadvantages of that proposal, As described above, in the time since (unbeknownst to the consumer) poorer including general comments that the issuance of the L&E Final Rule, the body broad spectrum protection than a proposal was overcomplicated, specific of evidence showing the harms of UVA product labeled as broad spectrum with comments on the proposed in vitro exposure, and of UVA I exposure, in a lower SPF value (depending on the testing method, and comments particular, has grown significantly (Refs.

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159, 161, 162, 166, 167, and 169). It is higher levels of UVA radiation than if current labeling regime, in which a now clear that in addition to producing they had not been protected from higher numbered product (for example, the immunosuppression described sunburn. Given the increasing evidence one labeled SPF 30) may provide above, UVA I exposure also results in of major health risks associated with inferior protection against UVA increasing DNA damage with increasing UVA exposure, we propose to find that radiation than a lower numbered skin depth (in contrast to UVB-induced such products (those with SPF values of product (for example, one labeled Broad DNA damage, which is reduced as skin 15 and greater that do not provide Spectrum SPF 15). depth increases). In addition, given that sufficient protection across the UV c. Sunscreen products with SPFs <15. UVA I is the predominant portion of spectrum (as demonstrated by satisfying As noted above and in section III.A.2, UVA radiation, new evidence FDA’s revised broad spectrum sunscreen products with SPF values (discussed in section IX.B.2) requirement)) are not GRASE. At the below 15 have not been shown to strengthening the link between UVA same time, we conclude that the reduce the risk of skin cancer or early radiation and skin cancer development evidence described above regarding the skin aging caused by the sun, whether raises our concerns about the potential contribution of UVA I to skin or not they provide broad spectrum for inadequate protection in the UVA I carcinogenesis, coupled with the protection. Because of this limitation, portion of the UV spectrum. evidence reviewed in the 2011 L&E we considered proposing to remove Accordingly, we no longer agree with Final Rule (see 76 FR 35620 at 35630– from the monograph sunscreen products the earlier comments suggesting that 35634), supports the proposal to include with SPF values lower than 15. UVA I does not contribute significantly sunscreen products that have an SPF of However, as the Surgeon General has to the harmful effects of exposure to UV 15 or higher and also pass the revised acknowledged (Ref. 5), some consumers radiation, or with our 2011 conclusion broad spectrum test in the sunscreen may seek intentional sun exposure that a UVA I/UV ratio requirement monograph with indications both for because (for example) they associate would therefore place too much use to help prevent sunburn and for use, tanned skin with attractiveness and emphasis on this portion of the UV as directed with other sun protection health. These consumers may seek some spectrum. measures, to reduce the risk of skin protection from sunburns and therefore, We emphasize that we are not cancer and early skin aging caused by select a low SPF product (i.e., one with proposing to replace the existing critical the sun. As we indicated in the L&E an SPF value below 15). If such wavelength test, and that the proposed Final Rule, the whole range of UV products are removed from the market, ratio would supplement (and be radiation, and not specific wavelengths, these consumers may choose not to use calculated using data from) the existing is a human carcinogen, and the exact a sunscreen product at all rather than broad spectrum test. We also note that wavelengths most responsible for these use a broad spectrum product with an the UVA I/UV ratio we are proposing harmful effects are not known (see id. at SPF of 15 or above. would result in a level of UVA 35631, 35633). To assure that a Although the benefits of sunscreen protection similar to what is achieved clinically meaningful reduction in the products with SPFs below 15 (which are via the European Union’s recommended risks of skin cancer and early skin aging not indicated to reduce the risk of skin 1 minimum UVA protection factor of ⁄3 of is achieved, then, a product must cancer or early skin aging) are limited, the labeled SPF and via the United contribute to substantially limiting FDA believes that the use of such Kingdom’s Boots 3-star rating (the overall UVB and UVA exposure (see id. products is preferable to the use of no United Kingdom has for decades used a at 35630, 35631–35632), as will be sunscreen at all. Thus, to provide sunburn protection for these consumers, tiered star rating system based on an assured by our proposal to couple the FDA is proposing that sunscreens with alternative ratio method) (Refs. 173 and enhanced breadth of protection across SPF 2 to 14 that bear prominent labeling 174). We note that data collected in the UVA spectrum provided by the regarding their limited use for sunburn 2009 about 330 sunscreen products revised pass criteria for the broad prevention and the risks associated with commercially available in the United spectrum test with the magnitude of spending time in the sun (see sections States showed that, at that time, more protection assured by requiring a IX.B.1 and IX.C) may remain on the than half of these products already minimum SPF of 15. satisfied the broad spectrum test we are By requiring that all sunscreens with market without approved NDAs. now proposing (see Comment, Docket SPF values of 15 or more satisfy the Because products with SPFs below 15 No. FDA–1978–N–0018–0690). (new) broad spectrum standard have not been demonstrated to reduce b. Broad spectrum requirement for all (including the new ratio requiring the risk of skin cancer, FDA is not products that are ≥SPF 15. We are also proportionate protection), this proposal proposing to require products with SPF proposing to require that all sunscreen will also enable consumers to select a values under 15 to pass the broad products with SPF values of 15 and product primarily by numerical (SPF) spectrum test. However, we seek above demonstrate that they provide value on the label, having assurance comment on whether the limited more uniform protection across the that, when used as directed, a product benefits such sunscreen products confer UVA I, UVA II, and UVB ranges of the labeled with a higher numerical SPF outweigh the risks of sunscreen drug UV spectrum by satisfying FDA’s value provides proportionately more exposure and the potential false sense of revised broad spectrum test. This security provided regarding UV proposal is designed to link increases in protection not only against sunburn, but also against skin cancer and skin aging protection (i.e., whether such sunburn- SPF value not only to increases in UVB only sunscreen products are GRASE and than lower numbered products 41 protection, but to increases in the should remain on the market without (provided that the product provides an magnitude of UVA protection as well. approved NDAs). We note that a consumer using a SPF of at least 15). In doing so, this sunscreen that provides robust proposal also eliminates another source 4. Maximum SPF Value Proposals protection against sunburn but that does of potential confusion permitted by the a. Maximum labeled SPF value would not pass FDA’s revised broad spectrum be SPF 60+. In conjunction with the 41 As noted in section III.A.2, only those broad test—and therefore provides inadequate spectrum sunscreen products that have an SPF of broad spectrum proposals described UVA protection—may fail to get out of 15 or higher have been shown to help prevent skin above, we are also proposing to raise the the sun, thereby exposing themselves to cancer and early skin aging. maximum labeled SPF value for

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products containing sunscreen light eruption in subjects using broad on the subject’s back. Because the monograph active ingredients to SPF spectrum SPF 60 versus SPF 50 administered UV dose series for the 60+. Under this proposal, sunscreen products (Ref. 179)). Based on the final minimal erythema dose (MED) 43 of products with SPF values of 60 or additional meaningful clinical benefit a sunscreen with an expected SPF of 60 greater would be labeled ‘‘SPF 60+.’’ provided by broad spectrum SPF 60 increases by 15 percent with each FDA has proposed to raise the sunscreens shown in these studies, we successive dose (see § 201.327(i)(5)(iii)), maximum SPF value that sunscreens are proposing to raise the maximum a difference in judgment of one site in marketed pursuant to the OTC labeled SPF value to SPF 60+. opposing directions would result in up Monograph System can display on their Because the studies demonstrating the to approximately 30 percent variability labeling several times. In the 1978 additional meaningful clinical benefit in the assessment of the amount of notice of proposed rulemaking, we provided by SPF 60 sunscreens all used exposure that resulted in the proposed that such sunscreens be sunscreens that also provided broad erythema.44 labeled with a maximum SPF value of spectrum protection, however, the Allowing the marketing of sunscreen 15 (43 FR 38206 at 38213 to 38214). In additional clinical benefit shown to monograph products with determined the 1999 final monograph, we exist at SPF 60 cannot be decoupled SPF test results up to 80 would, determined that that cap should be from the broad spectrum protection therefore, more fully account for the increased to SPF 30+ (64 FR 27666 at provided by those products. That is, the range of variability in SPF test results 27675). In 2007 (72 FR 49070 at 49085 additional meaningful clinical benefit for sunscreen products labeled SPF 60+. to 49087) and then in 2011 (Max SPF shown in these studies may have been We are also proposing this formulation PR), we tentatively concluded that data the result of the sunscreens’ protection margin to provide manufacturers with existed to show that sunscreens with against rays in the UVB range or in the additional formulation flexibility that labeled SPF values of up to 50+ provide UVA range, or both. For this reason, our we hope will help facilitate the additional clinical benefit to consumers. proposal to recognize the additional development of products with greater Our proposal today to increase the meaningful clinical benefit provided by UVA protection, given our expectation maximum labeled SPF value to 60+ is sunscreens with SPF values above 50 is that active ingredients added for the similarly based on data showing the consistent with, and dependent upon, primary purpose of increasing UVA additional clinical benefit provided by our proposal that all sunscreen products protection would contribute to a SPF 60 sunscreen products when those with SPF values of 15 and above be sunscreen’s determined SPF value as products also provide broad spectrum required to provide broad spectrum well. We seek comment on whether SPF protection. protection. 80 is the appropriate formulation cap to In the 2011 Max SPF PR proposing an Given the lack of data showing that accomplish these objectives. SPF 50+ cap, we noted that the record, sunscreens with SPF values above 60 We are proposing not to allow the at that time, lacked adequate data provide additional meaningful clinical marketing (without an approved NDA) demonstrating that sunscreen products benefit, however, we are proposing not of sunscreen products with determined with SPF values above 50 provided to allow labeled SPF values higher than SPF values above SPF 80. This proposal additional meaningful clinical benefit 60+. Labeling sunscreen products with follows from the principle that if the over and above what was provided by SPF values higher than what has been addition of ingredients to a drug does SPF 50 protection (76 FR 35672 at shown to provide additional meaningful not provide additional clinical benefit 35672 to 35674). We requested data clinical benefit could have unintended but potentially increases the risk showing that such clinical benefits negative consequences. For example, as associated with the drug, this shifts the existed (id.). In response to both the discussed above, such products may benefit-risk calculation and renders the 2007 and 2011 proposals, we received inadvertently promote extended solar drug not GRASE (see, e.g., 76 FR 35673 comments providing citations to data exposures because consumers feel at 35675). In light of this principle, we showing the additional meaningful protected and assume that the higher solicited comments in 2011 on the clinical benefit provided by sunscreen SPF value implies that greater UV appropriateness of a formulation cap for products with SPF values of 60 for exposure is safe (see, e.g., Autier, et al., sunscreen products (id.). certain at-risk populations when those 2007 (Ref. 171)). Some of the comments that we sunscreens also included broad b. Formulation cap for sunscreen received in response to the 2011 Max spectrum protection. (See, e.g., Ulrich et products of SPF 80. Although we are SPF PR expressed concerns (in general) al. (showing statistically significant proposing that the maximum labeled about the safety of unnecessary protection of organ transplant SPF value will be SPF 60+, we are exposure to sunscreen active recipients, who are highly susceptible to proposing to permit the marketing of ingredients. We received only one nonmelanoma skin cancer, from sunscreen products formulated with comment, however, directly addressing squamous cell carcinoma with use of determined 42 SPF values up to 80. We the question of an SPF formulation cap. broad spectrum SPF 60 sunscreen) (Ref. are proposing to permit this additional That comment emphasized that there 176); see also Comment FDA–1978–N– formulation margin in part because of was no formulation limit in other 0018–0710, August 31, 2011, citing the inherent variability in SPF test countries using an SPF labeling cap, and Kuhn et al. (showing statistically results. A sunscreen product’s SPF significant prevention of skin lesions in value is calculated from measurements 43 The minimal erythema dose (MED) is the topical lupus erythematosus patients that are based on an investigator’s visual smallest UV dose that produces perceptible redness with use of broad spectrum SPF 60 evaluation of an individual test subject’s of the skin (erythema) with clearly defined borders sunscreen after exposure to either UVA erythema response to a series of UV at 16 to 24 hours after UV exposure (§ 201.327(i)(5)(i)). I source or UVA II/UVB source) (Ref. doses administered in successive sites 44 The determination of SPF for each subject is 177); Faurschou et al. (showing calculated via a ratio of the MED of protected skin prevention of urticarial reaction in 42 As used in this preamble, the determined SPF over the final MED of unprotected skin. In a subjects with idiopathic solar urticaria value is the SPF value that equals the largest whole scenario in which the final MED of unprotected number less than SPF¥(t*SE), determined for a skin is underestimated by 15 percent and the MED with use of broad spectrum SPF 60 sunscreen product in accordance with § 201.327(i). of protected skin is overestimated by 15 percent, sunscreen) (Ref. 178); Fourtanier et al. See also section IX.D.2.b, where we propose to this would present approximately 30 percent (showing lower levels of polymorphous define this term in the regulation. variability for the individual subject.

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that the list of permitted active This proposal is designed to avoid lab was not told the target SPF, but was ingredients in the monograph itself misleading consumers about the relative rather given a range of SPF 20 to 100 for establishes an SPF ceiling for the efficacy of sunscreen products, given a product with an expected SPF of 100. formulation as a whole. FDA rejects the the lack of clinical data showing The results showed that it was premise that the list of permitted active meaningful efficacy differences between extremely difficult for labs to reproduce ingredients establishes an adequate SPF closely grouped SPF values. We note the labeled SPF 100, with mean SPF cap for sunscreen formulations, as this that in the 2011 L&E Final Rule, FDA values ranging from 37 to 75. In a theory does not take into account the declined a request that SPF be labeled second study with multiple panels of 25 potential addition of new GRASE in multiples of five, stating that there subjects that was controlled and ingredients to the list of active was no mathematical or statistical basis randomized, the determined SPF of two ingredients under the monograph. This for this labeling approach because SPF sunscreen formulations tested across comment also appears to imply that the values could generally be determined four labs ranged from 63 to 69 for a maximum concentration of each active with a precision that allowed for SPF target SPF 70 and from 82 to 89 for a ingredient correlates specifically to a values to be labeled in intervals of less target SPF 90 (Ref. 182). Although the particular numerical contribution to the than five units. New data showing magnitude of the differences observed total SPF value of the product. This has variability both between tested SPF in this second study were not not been established (see 64 FR 27666 values for individual study subjects and statistically significant, the fact that at 27674 and 27675 (noting that for determined SPF results achieved multiple labs determined different formulation techniques may enable across multiple labs testing the same specific numerical values for a single increases in SPF without use of higher sunscreen formulation (i.e., variability formulation suggests that the use of concentrations of active ingredients)). In inherent in a clinical test that relies on labeled values representing ranges more addition, as mentioned in 2011 in the visual assessments) (FDA–1978–N– accurately represents the sun protection Max SPF PR (76 FR 35672 at 35674), the 0018–0740, 2011; Ref. 182), however, provided by a product, and therefore is theoretical increase in protection has caused us to reexamine this issue. appropriate to avoid misleading implied by higher SPF values generated As described above, the clinical SPF consumers. in a laboratory does not necessarily test is conducted using a solar simulator We note that variability in SPF values correspond to meaningful additional to administer several specified doses of is exacerbated at high SPFs. For sunburn protection for consumers in UV radiation that increase by 15 to 25 example, individual test results with 30 actual use conditions. Given that a solar percent with each successive dose to a percent variability from a determined simulator in a lab can produce much human subject’s back in both sunscreen- SPF value of 20 would range from SPF higher UV doses than a consumer would treated and untreated areas (with the 14 to SPF 26; individual test results receive from the sun (even in the most specific UV doses being derived from with 30 percent variability from a extreme situations), it is unlikely that a the expected SPF of the product and a determined SPF value of 50 would consumer could ever actually reach the determination of the individual range from SPF 35 to SPF 65. theoretical ceiling created by the list of subject’s UV sensitivity). The clinical Accordingly, as shown in table 5, we permitted active ingredients. investigator then visually evaluates both propose that the range of tested values Given the lack of demonstrated the sunscreen-treated and untreated reflected in the labeled SPF number clinical benefit for sunscreens with areas of the subject’s back to identify the should be wider at higher SPF values determined SPF values above SPF 60, areas with perceptible skin redness and narrower at lower ones, and that the and the potential for risks—discussed (erythema) that has clearly defined requirement that labeled SPF values elsewhere in this document—associated borders. Determining which of several correspond to ranges rather than precise with exposure to sunscreen active areas on a single subject’s back should numerical values is not necessary below ingredients, we propose not to permit be considered to meet this ‘‘clearly SPF 15. the marketing (without an approved defined borders’’ criteria is an exercise NDA) of sunscreen products with of clinical judgment. Once the TABLE 5—PROPOSED SPF LABELING determined SPF values above SPF 80 investigator has made this judgment, he RANGES (which reflects a formulation margin or she then records the smallest dose of intended both to give full effect to the UV radiation it took to create an area Range of SPF 60 limit and to enable formulation with the observed skin reaction of Associated labeled SPF determined value flexibility). erythema with clearly defined borders. SPF values c. Proposal for ≥SPF 15 labeling. After assessing multiple individual test Finally, we are proposing to require that subjects this way, the resulting UV 60–80 ...... 60+. 50–59 ...... 50. sunscreen monograph products with exposure information is used in determined SPF values of 15 or above be 40–49 ...... 40. calculating the determined SPF value of 30–39 ...... 30. labeled with an SPF number the sunscreen being tested. The data we 25–29 ...... 25. corresponding to the lowest number in reviewed suggest that the clinical 20–24 ...... 20. a range of tested SPF results, as shown evaluation undertaken during this 15–19 ...... 15. in table 5.45 For example, sunscreens process creates variability that justifies 2–14 ...... Determined SPF Value. testing at SPF 15 to 19 would be labeled the use of SPF ranges. ‘‘SPF 15’’; those testing at 40 to 49 For example, in a study using panels C. Proposed PDP Labeling Requirements would be labeled ‘‘SPF 40.’’ 46 of five subjects, the mean SPF values We are also proposing some revisions observed across multiple labs ranged to the principal display panel (PDP) for 45 We note that the use of ranges to represent SPF from 54 to 82 for a target SPF 80 (FDA– sunscreen products (the PDP is the values on product labeling is already in use in 1978–N–0018–0740, 2011). This same Australia and the European Union (Refs. 180 and portion of an OTC drug product label study also evaluated a scenario where a 181). that is most evident when the product 46 The proposed labeled values are expressed in is displayed for retail sale (§ 201.60)). In increments of 5 for products with determined SPF proposed labeled values are expressed in results of 15 to 29.9 (i.e., SPF 15, SPF 20, SPF 25), increments of 10 (i.e., SPF 30, SPF 40, SPF 50, with addition to satisfying general OTC drug but for determined SPF results of 30 or more, the a proposed maximum of SPF 60+.). labeling requirements found in part 201,

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sunscreen product PDPs are currently given product accordingly. As an with no intervening text or graphic. To required to satisfy specific labeling indication that consumers value further ensure the prominence and requirements in § 201.327. We are information about a sunscreen’s active readability of information that is proposing to amend these requirements ingredients, an analysis of top-rated important for consumers to evaluate and for sunscreen PDP labeling (currently sunscreen product reviews on compare sunscreen products, we codified in § 201.327(a) and (b), and (for Amazon.com found that product propose that these statements must also the statement of identity of products ingredients were listed as a positive appear in bold typeface at least one- that also include skin protectants) in factor in 17 percent of responses, and a fourth the size of the most prominent § 201.327(h)) to help consumers better negative factor in 10 percent of printed matter on the PDP, and as text understand, evaluate, and compare responses (Ref. 183). generally parallel to the base of the sunscreen products by providing Based on a review of marketed packaging. additional information on the PDP, and sunscreen product labels, FDA is The proposed new ‘‘*See Skin by ensuring the prominence and concerned that the SOI may currently be Cancer/Skin Aging Alert’’ statement readability of information required to obscured by the inclusion and would also be required to appear in bold appear on the front of the container or prominence of other printed or graphic typeface at least one-fourth the size of package. We are also proposing to information on the PDP. For this reason, the most prominent printed matter on renumber and consolidate provisions on we also propose to require the SOI to the PDP, and as text generally parallel PDP labeling and the statement of appear in direct conjunction with the to the base of the packaging. In addition, identity (SOI) in § 201.327(b) to most prominent display of the the entire statement would appear in the incorporate new proposed provisions in proprietary name, in a boldface font at same font style, size, and color with the § 201.327(a), as described in section least one-fourth the size of the most same background color, and as IX.D.2.b of this preamble. In addition, prominent printed matter on the PDP, continuous text with no intervening text we are proposing that labeling a and displayed so that the text is or graphic. sunscreen product in accordance with generally parallel to the base of the Finally, because water resistance is proposed § 201.327(b) would be a packaging. We propose that the entire also an important characteristic for condition for marketing a sunscreen SOI appear in the same font style, size, consumers when choosing a sunscreen, under the OTC sunscreen monograph in and color with the same background we also propose to apply comparable part 352. color, and as continuous text with no format requirements to the current We are proposing to revise the current intervening text or graphic material ‘‘Water Resistant’’ statement. The SOI, which is required to appear on the other than text provided in accordance statement would also be required to PDP by both current and proposed with the requirements for the SOI for a appear in bold typeface at least one- § 201.327. Currently, the SOI for product that also includes a skin fourth the size of the most prominent sunscreens under this regulation protectant, where applicable. These printed matter on the PDP, and contains ‘‘the established name of the requirements would supplement, and displayed so that the text is generally drug, if any’’ and identifies the product not replace, the general requirements parallel to the base of the packaging. In as a ‘‘sunscreen.’’ The revised SOI regarding the PDP and SOI for all addition, the entire statement would would consist of an alphabetical listing nonprescription products in §§ 201.60 appear in the same font style, size, and of all sunscreen active ingredients in the and 201.61. color with the same background color, product using the names shown in Proposed § 201.327(b) would and as continuous text with no § 201.327, followed by ‘‘Sunscreen’’ and incorporate the ‘‘Broad Spectrum SPF,’’ intervening text or graphic. the product’s dosage form (such as ‘‘SPF,’’ and ‘‘Water Resistant’’ lotion or spray). In light of these statements that already must appear on D. Proposed Requirements Related to proposed changes to the SOI for the PDP as described in current Final Formulation Testing and sunscreens, we are also proposing § 201.327(a). Additionally, for all Recordkeeping harmonizing changes to the provisions products with SPF values below 15, we We are also proposing a number of that address the SOI for products that propose to require that the SPF revisions in § 201.327: (1) To ensure that combine sunscreen and skin protectant statement be followed by an asterisk (*) efficacy testing of the sunscreen active ingredients (proposed directing the consumer to the statement formulation to be marketed is conducted § 201.327(h) and cross-referenced in the ‘‘*See Skin Cancer/Skin Aging Alert.’’ in a way that protects human subjects sunscreen monograph in § 352.60 (21 We propose that the quoted statement and produces reliable results and (2) to CFR 352.60) and in the skin protectant must appear in the bottom 30 percent of enable FDA to assess compliance with monograph in § 347.60 (21 CFR the PDP. This statement is intended to this section’s provisions going forward. 347.60)). draw the consumer’s attention to the We also propose to make compliance The proposal to list all active Skin Cancer/Skin Aging Alert that with these requirements a monograph ingredients as part of the SOI is would continue to be required for these condition in part 352. generally consistent with SOI labeling of products as part of the ‘‘Warnings’’ in other OTC and prescription drugs. the Drug Facts portion of the label 1. General Approach to Final Providing information about a product’s (§ 301.327(d)), because there is evidence Formulation Testing active ingredients and dosage form that some sunscreen consumers are not Current § 201.327 includes technical would supplement other important reading this information in its current instructions for conducting the final elements of the PDP (SPF, broad location (Refs. 184 and 185). formulation testing required to support spectrum, and water resistance Under the current regulation, the the SPF values, water resistance information) to provide a succinct entirety of the ‘‘Broad Spectrum SPF’’ or statements, and broad spectrum summary of the product’s key ‘‘SPF’’ statement, as applicable, must statements shown in sunscreen product characteristics on the front of the appear on the sunscreen PDP in the labeling. However, the current package or container. We expect that same font style, size, and color and with regulation does not explicitly address this approach would enable consumers the same background color, and, if used, important broader considerations that to more readily compare differing the ‘‘Broad Spectrum SPF’’ statement are essential to ensure that final products and either select or avoid a must also appear as continuous text formulation testing is conducted and

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documented in a way that verifiably actions to verify the reliability of final test reports are accurate and valid. This provides for protection of human formulation testing under the current is also true with respect to subjects in SPF and water resistance provisions of § 201.327 have raised documentation of emission spectrum, testing, as well as ensuring the some questions about current practices. the percentage of erythema-effective reliability of all the testing data that For example, FDA’s observations have radiation contribution, and changes to underlies sunscreen labeling. We expect raised questions about whether and how solar simulator components and the UV that persons responsible for conducting entities conducting final formulation meter/dose controller system. Failure to final formulation testing should already testing have put in place protocols and accurately calibrate and maintain be following best practices in their IRB oversight to ensure that test subjects equipment at one testing entity may current testing programs. However, we do not repeat participation in testing affect data across multiple clinical SPF are concerned that many entities may with a frequency that could both testing studies and/or broad spectrum not uniformly observe such practices compromise the ability to distinguish testing for multiple different final and/or may not maintain the records erythemic reactions to the test article formulations that are ultimately sold needed to document compliance with and raise other questions about human under different labels. Inadequate the final formulation testing procedures subject protection. We are concerned recordkeeping may interfere with set forth in § 201.327. FDA’s experience that the lack of explicit requirements efficient enforcement. We propose to in conducting inspections and other with regard to IRB oversight, as well as address these concerns and align the actions to verify testing under the the cursory nature of the informed regulation with our existing current provisions of § 201.327 have consent requirement in the current expectations through revised regulatory suggested latent problems in these areas. sunscreen labeling regulation, may provisions that are described further in Although limited, this experience result in inconsistent practices in the the following sections. reinforces FDA’s belief that further conduct of SPF testing that would 2. Specific Regulatory Proposals clarification of regulatory expectations compromise the reliability of results. is necessary given the public health Among other things, IRB review is a. Consequences of failure to observe importance of ensuring that sunscreen critical to verify the adequacy of best practices. We propose to clarify in products are effective and accurately informed consent and to ensure that the introductory paragraph of § 201.327 labeled, and the broad range of entities study protocols incorporate appropriate that a product is deemed misbranded if that may be involved in bringing inclusion/exclusion criteria for subject its labeling relies on the results of final sunscreen products to market. Thus, we selection (both to protect test subjects formulation testing that was not are proposing to incorporate FDA’s and to ensure the accuracy of results). conducted in compliance with all of the current expectations more explicitly in b. Qualifications of study personnel. applicable provisions of § 201.327. the revised provisions. The proposed In some instances, it may not be clear Unless testing is conducted in provisions are broadly consistent with upon inspection whether all aspects of compliance with all applicable current best practices for efficacy testing a study were conducted by provisions of § 201.327, FDA does not conducted in human subjects, and are appropriately qualified personnel. For have adequate assurance that the not expected to require significant example, FDA would not consider it labeling reliably reflects the properties changes by reputable and experienced adequate for a technician, rather than an of the sunscreen product. Therefore, if testing establishments. Key areas of appropriately trained medical final formulation testing is not properly concern that are addressed by the professional (such as, for example, a conducted in accordance with this proposed revisions include the nurse or dermatologist), to perform a section, labeling a sunscreen with an following. physical examination for potential nevi, SPF value or representation of water a. Protection of human subjects and moles, or other dermal lesions. As with resistance or broad spectrum properties oversight of clinical final formulation all clinical and nonclinical testing done based on that testing is a testing. Ensuring that clinical final to support labeling, the use of properly misrepresentation to the consumer that formulation testing is both designed and trained and appropriately qualified the labeling reliably states the product’s conducted in a manner that will yield personnel is essential to ensure the properties, which should also be reliable results is critical, as is ensuring reliability and accuracy of test results. consistent with a system of standardized the protection of the human subjects on Documentation of the qualifications and sunscreen labeling that can be used to whom SPF and water resistance testing training of personnel is also necessary to make cross-product comparisons. We are conducted. Existing provisions enable FDA’s efficient enforcement of propose to incorporate the provisions of within the SPF test in § 201.327(i)(3)(iv) the FD&C Act. § 201.327(a) through (l) into part 352 as require that informed consent be c. Documentation of equipment conditions under which a sunscreen is obtained, but do not otherwise specify maintenance, study methods, and GRASE and not misbranded. If these what this should involve or how clinical observations. Failure to maintain provisions are finalized, failure to final formulation testing should be adequate records of testing equipment, comply with these conditions would overseen. Across disciplines, testing methods, and observations can raise make a drug subject to regulatory action involving human subjects is ordinarily broad questions about the reliability of as misbranded and an unapproved new conducted under institutional review final formulation testing. In FDA’s drug. board (IRB) oversight as a means of experience since the promulgation of b. General obligations of responsible ensuring that informed consent and current § 201.327, there has been a lack persons. We are aware that many other human subject protections are of uniformity in testing entities’ different business relationships provided and ensuring the integrity of approaches to recordkeeping for final involving numerous entities are study design and execution. FDA formulation testing, raising concerns commonly used in the manufacturing, likewise expects that IRB review is about the adequacy of recordkeeping testing, and labeling of nonprescription already routinely being obtained by procedures. Failure of testing entities to sunscreen drug products. To clarify the many establishments for SPF and water keep adequate records to support final locus of responsibility for ensuring that resistance testing. formulation testing may leave FDA adequate final formulation testing Nonetheless, our experience in unable to verify that the UV doses procedures are in place, and to clearly conducting inspections and other provided in SPF and water resistance delineate responsibility for

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recordkeeping related to final ensure that investigators and other matter of good clinical practice, IRB formulation testing, FDA proposes a personnel conducting investigations approval should already be routinely new defined term, responsible person. under § 201.327(i) comply with currently obtained for clinical final We propose to define the term requirements related to human subject formulation testing under current responsible person in a way that is protection and the appropriate conduct § 201.327 because it is essential to consistent with FDA’s treatment of of clinical testing. We believe that this producing results that are scientifically regulatory responsibilities for other OTC better reflects the employer/employee sound and ethically appropriate. drug products and that is in alignment relationships that are more common in Because clinical final formulation with requirements for adverse event connection with final formulation testing required to support labeling reporting for over-the-counter drug testing rather than with clinical testing under current § 201.327 is not products, in section 760(b)(1) of the conducted under an IND. These conducted under an IND or in support FD&C Act. The proposed definition for proposed provisions regarding selection of a GRASE determination in the OTC responsible person is ‘‘the manufacturer, of personnel are also consistent with the sunscreen monograph, it was not packer, or distributor whose name existing obligations of manufacturers previously included explicitly in the appears on the labeling of a sunscreen under parts 210 and 211 (21 CFR parts scope of testing covered by parts 50 and product covered by this section.’’ 210 and 211), both of which govern 56. We propose to rectify this omission Defining responsible person in this way compliance with CGMPs. by explicitly cross-referencing parts 50 will enable FDA to better assess The proposed revision of and 56 in revised § 201.327(i). This will compliance with § 201.327 because it § 201.327(a)(1) permits a responsible clarify that both of these parts apply to creates a chain of responsibility that is person to transfer some or all of its clinical final formulation testing and immediately apparent from the obligations to another entity, consistent will resolve any inconsistency in product’s labeling. The responsible with current industry practice, except current practice. person, as identified on the labeling, is for obligations with respect to The proposed reference to part 50 ultimately responsible for ensuring that recordkeeping. The recordkeeping clarifies FDA’s position that legally the product bearing its name is labeled proposal is discussed in section IX.D. effective written informed consent to in accordance with the requirements of Failure of an entity to comply with participate in clinical final formulation § 201.327. provisions of this part governing testing should share the same properties The proposed revision of § 201.327(a) responsibilities it has assumed would as informed consent required for all would broadly set forth the general subject that entity to the same regulatory other clinical testing covered by FDA’s obligations of responsible persons with action as if it were a responsible person regulations in part 50. Similarly, by respect to final formulation testing who had failed to comply with those referencing part 56, the proposal under § 201.327(i) and (j), and it would obligations. This provision is analogous ensures that final formulation testing is make clear that the responsible person to the provision in FDA’s regulations at held to the same standards for IRB is charged with ensuring that sunscreen part 312 allowing for transfer of review as other clinical testing covered products are appropriately tested. The obligations of IND sponsors. by FDA’s regulations. In reviewing obligations of responsible persons as c. Adequate clinical testing clinical protocols, IRBs have the ability enumerated in § 201.327 are modeled procedures and conditions. Although to determine whether the protocol is after those of investigational new drug current § 201.327 requires ‘‘legally adequately designed to study the application (IND) sponsors under part effective written informed consent from endpoints sought, and to ensure that 312 (21 CFR part 312), but are somewhat all test subjects’’ (§ 201.327(i)(3)(iv)), it protocol elements, such as enrollment modified to accommodate unique does not address broader underlying criteria, adequately protect both human aspects of clinical and nonclinical requirements for conducting clinical subjects and the scientific rigor of the sunscreen formulation testing. Because testing. In light of the concerns we experiment. final formulation testing under identified regarding current clinical d. Control of personnel. We propose § 201.327(i) and (j) is intended to verify testing procedures and conditions, we to place responsibility on the the claimed properties of a final propose to amend § 201.327 by adding responsible person to ensure that formulation, and because this purpose is paragraph (i)(1), ‘‘Adequate Clinical investigators and other personnel narrower in scope and duration than Testing Procedures and Conditions.’’ conducting clinical final formulation most clinical testing performed under We expect that final formulation testing testing adhere to the investigational FDA’s IND regulations in part 312, a conducted in compliance with the plan, the signed investigator statement, responsible person under proposed proposals in this paragraph will be more and all applicable regulations. We also § 201.327 would have responsibilities likely to ensure protection of human propose to place responsibility on the that incorporate some of the traditional subjects while also more reliably responsible person for ensuring human responsibilities of investigators as well determining the SPF value and water subjects’ protection, including through as those of sponsors under part 312. For resistance properties of the final appropriately reporting changes in the example, FDA proposes to clarify that formulations being tested. Unless testing to IRBs, and by appropriately responsible persons must select appropriate clinical testing procedures seeking prior IRB approval for any appropriately qualified personnel to and conditions are adhered to, FDA changes to the testing, except where conduct testing, ensure compliance with cannot have confidence in the resulting necessary to eliminate apparent the requirements for IRB review and labeled SPF and water resistance immediate hazards to human subjects. obtaining informed consent, and properties of the product. Under the proposed rule, responsible monitor the compliance of personnel Proposed § 201.327(i)1(B) and (C) persons are also expected to obtain from with investigators’ statements. have been added to make clear that each investigator, and retain for their This proposed approach accounts for FDA’s regulations governing informed records, a signed investigator statement. situations in which investigators and consent (part 50 (21 CFR part 50)) and This is similar to what is required of other personnel conducting final IRB approval of research (part 56 (21 sponsors of INDs, and it helps to ensure formulation testing are employees of the CFR part 56)) apply to clinical final that the investigator is qualified, responsible person. We also propose to formulation testing that is conducted understands his or her obligations, and clarify that the responsible person must under § 201.327(i). In our view, as a will comply with the requirements of

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this paragraph and with the protocol. It individuals who have participated in parts 210 and 211 includes compliance also enables better oversight of clinical sunbathing, tanning bed use, or another with the requirements to keep certain investigations by FDA because it creates SPF clinical study for at least the past records and to have appropriately a record of the investigator’s relevant 4 weeks or perhaps longer if UV- trained and qualified personnel. Failure experience and qualifications. induced responses remain. The to comply with CGMPs results in a e. Research monitoring. A number of proposed clarification regarding product being adulterated under section changes in § 201.327(i)(1) are being conduct of physical examinations of test 501(a)(2)(B) of the FD&C Act. proposed to ensure adequate monitoring subjects reflects this consideration, and h. Recordkeeping. To enable FDA to of clinical final formulation testing. our additional proposal for IRB review, better monitor compliance with the Revised § 201.327(i)(1) would require addressed elsewhere, will help ensure it requirements of § 201.327, we propose that responsible parties inform all is appropriately acted on. to include specific recordkeeping investigators testing a formulation if g. Applicability of registration and requirements for final formulation there are new observations about the CGMP requirements. Proposed testing. Accordingly, proposed drug, particularly with regard to adverse § 201.327(k) reflects FDA’s existing view § 201.327(l) clarifies what records of events or safe use. This is necessary to that final formulation testing conducted testing performed under this section ensure proper communication between under § 201.327 constitutes the must be kept, by whom, and for how study personnel and protection of ‘‘manufacture’’ of a drug. As such, this long. This provision also allocates human subjects. Responsible persons testing must be conducted in an responsibility for records maintenance must also monitor the conduct of establishment registered in accordance and specifies what records must be investigations to ensure that clinical with part 207 (21 CFR part 207) and made available to FDA for inspection. testing is being conducted in accordance section 510 of the FD&C Act. This Recordkeeping is essential for FDA to with the protocol and with applicable interpretation is consistent with the evaluate whether required testing of regulations. If a responsible person definition of manufacture in part 207, final formulations is being conducted in discovers noncompliance by study which includes ‘‘each step in the accordance with § 201.327(i) and (j), and personnel, then the responsible person manufacture, preparation, propagation, to enable the Agency to investigate must either secure compliance or compounding, or processing of a drug postmarketing product failures or remove the noncompliant personnel . . . .’’ (§ 207.1). The definition of adverse events. Appropriate from conducting testing. manufacture as used in part 207 also recordkeeping also enables FDA to Finally, we propose to require that ‘‘includes manipulation, sampling, conduct better and more efficient investigators report adverse events and/ testing, or control procedures applied to inspections of entities conducting final or safety concerns to the responsible the final product or to any part of the formulation testing. person, and that investigators also process, including, for example, These recordkeeping requirements are provide responsible persons with final analytical testing of drugs for another in alignment with what is required for reports at the conclusion of testing. We registered establishment’s drug’’ (id). other types of manufacturing under believe that this will ensure there is Accordingly, a sunscreen product CGMPs as set forth in parts 210 and 211. appropriate documentation and labeled in reliance on final formulation The proposed provisions are intended to communication of adverse events and/ testing done in an unregistered clarify how, and for how long, records or safety concerns that arise during establishment is misbranded under must be kept to substantiate required testing. It will also ensure there is a section 502(o) of the FD&C Act. This final formulation testing. We are record of SPF testing conducted under interpretation is also consistent with proposing that records of testing must § 201.327(i) that can be relied upon FDA’s regulations in § 330.1, which be kept by the responsible person (as should questions related to a particular require that OTC monograph drug newly defined in § 201.327(a), discussed formulation arise when the sunscreen products be manufactured in a previously), as well as by any other formulation is marketed. The proposed registered establishment in order to be entity that actually performs testing requirements are consistent with generally recognized as safe and (under a transfer of obligations per reporting required in the IND context, effective and not misbranded. The § 201.327(a)(1) or otherwise). Requiring although, because of the short duration incorporation of this provision in that records be kept by both the of the clinical final formulation testing § 201.327, therefore, is intended to responsible person and the testing entity conducted under § 201.327(i), we are clarify an existing requirement for (if different) will enable FDA to more not proposing to require annual facilities performing this type of testing. easily identify records supporting the reporting. We also propose to clarify that, as a labeling of any given final formulation f. Test subject selection. We propose manufacturing activity, final even when the product is labeled with additional language regarding the formulation testing conducted under the responsible person’s information, selection of test subjects in this paragraph is expected to be done in but testing and manufacturing was § 201.327(i)(4). This is an area in which accordance with CGMPs as set forth in completed by a third party. FDA’s inspections of testing entities parts 210 and 211 (see § 210.3(b)(12), The proposed recordkeeping have suggested a lack of consistency. indicating that for the purposes of parts requirements reflect FDA’s experience We are particularly concerned that 210 and 211, ‘‘Manufacture, processing, in interacting with regulated industry. inclusion/exclusion criteria provide for packing or holding of a drug product By requiring that records be kept by adequate time between study and includes packaging and labeling both the responsible person and any enrollment and prior UV exposure, such operations, testing, and quality control other entity that performs final as from participation in a previous SPF of drug products’’). This is consistent formulation testing, the proposed rule test, sunbathing, or sunlamp use. with FDA’s regulations in § 330.1, will enable more efficient enforcement Erythemal responses can remain for which require compliance with CGMPs of the FD&C Act by, for example, days after sunbathing, and it is known as a condition for OTC drug products to allowing FDA to identify the source of that pigmentation development takes up be GRASE and not misbranded when formulation failures or apparent to a week after initial exposure and otherwise marketed consistent with inconsistencies between the product remains for weeks to months (Ref. 186). conditions in a final monograph. labeling and consumer experience. The SPF clinical studies should not include Adherence to CGMP requirements in proposed recordkeeping requirements

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will also assist FDA when it is identity and strength, and meets the unprotected skin (initial MEDu); (2) a conducting inspections of entities that quality and purity characteristics, which final MED for unprotected skin (final perform final formulation testing for a it purports or is represented to possess. MEDu); (3) an MED for skin to which number of different responsible persons This proposal also elaborates on the SPF standard has been applied and products, as we believe is the norm recordkeeping necessary to document (ssMEDp); and (4) an MED for skin to in this industry. Having ready access to compliance with the requirements of which the sunscreen test product has records reflecting the overall conduct of proposed § 201.327 regarding conduct of been applied (tpMEDp). The initial final formulation testing during an final formulation testing. MEDu is used to set the UV exposures inspection of such an entity is important Proposed required records for SPF administered to determine final MEDu, because it will enable FDA to identify testing include records that: (1) Identify ssMEDp, and tpMEDp (see potential systemic problems in final the facility conducting the testing; (2) § 201.327(i)(5)(iii)). formulation testing that may have an identify the equipment used; (3) identify Although the regulation already impact on the reliability of results product samples and lots; (4) requires that each of the MED values be supporting the labeling of multiple characterize the SPF standard that is determined 16 to 24 hours after UV different sunscreen products marketed used; (5) document parameters for water exposure, it merely notes that the final by a variety of responsible persons. We resistance testing; and (6) demonstrate MEDu, ssMEDp, and tpMEDp are note that these recordkeeping compliance with the provisions ‘‘typically determined the day following requirements should not be understood governing adequate clinical testing determination of the initial MEDu’’ (see to mandate duplicative records within procedures and conditions. For current § 201.327(i)(5)(iv)). Because the the files of a single testing entity or example, these would include skin reactivity of a test subject changes single responsible party. For example, if documentation of IRB review, case over time, we propose to clarify that the one investigator is responsible for histories for each human subject (which initial MEDu of a person’s unprotected testing multiple final formulations, one must document protocol deviations or skin must be determined no more than copy of the signed investigator injuries), administration of the 1 day before the UV exposures for final statement and Curriculum Vitae (CV) sunscreen, and reading of test results. MEDu, ssMEDp, and tpMEDp are would be sufficient to support all These proposed recordkeeping administered. We are also clarifying that formulations tested by that investigator. obligations are consistent with those to calculate the SPF value for each test required of parties engaged in human subject, under proposed paragraph Consistent with FDA’s view that final subjects testing governed by other § 201.327(i)(6), it is the subject’s final formulation testing is manufacturing, portions of FDA’s regulations. MEDu that should be used. and thus is subject to CGMPs, Required records of broad spectrum In our review of the testing equipment maintenance records and testing conducted under proposed requirements as part of this rulemaking, other records documenting compliance § 201.327(j) would include those records we also revisited our position on the with CGMPs are expected to be necessary for identifying the facility input slit bandwidth specification in the maintained as required by parts 210 and conducting the testing, providing in vitro broad spectrum test. In the 2011 211. Accordingly, we clarify in information associated with the sample, L&E Final Rule, we modified the in vitro proposed § 201.327(l) that records identifying equipment used, and broad spectrum test that was proposed documenting proper maintenance of documenting sunscreen product in the 2007 proposed rule to change the equipment used in final formulation application. These proposed input slit spectrometer bandwidth testing must be kept, consistent with requirements provide greater specificity specification from ≤5 nm to ≤1 nm. existing obligations in 21 CFR 211.68. In than existing requirements in FDA’s After the 2011 final rule published, FDA our view, this clarification will promote CGMP regulations, and are expected to received a comment from a spectrometer uniformity in adherence to best increase uniformity in current practice. manufacturer arguing that the 1 nm practices and will help ensure more We propose to clarify FDA’s input slit bandwidth specification was accurate and reliable labeling of expectations regarding access to records unreasonable. The manufacturer argued sunscreen products based on final that responsible persons and other that common spectrometer models that formulation testing. Additional testing entities are required to keep are currently used to test sunscreens specificity has been proposed here to under this paragraph. These provisions cannot comply with the ≤1 nm input slit clarify how the more general are consistent with FDA’s inspection bandwidth specification, and those that recordkeeping provisions of part 211 authorities in section 704 of the FD&C can are more expensive, more difficult apply to final formulation testing. To Act. to use, and take more time to use. The provide assurance that the test results i. Minor proposed revisions to test manufacturer provided data that are not compromised by faulty procedures. In addition to the changes indicate that spectrometers with ≤1 nm equipment maintenance or equipment discussed in section IX.D, we are input slit bandwidths do not produce failure, FDA proposes that testing proposing several modifications to the more reliable results than spectrometers entities must keep documentation technical instructions for sunscreen with larger input slit bandwidths (see demonstrating that equipment used for final formulation testing (§ 201.327(i) Comment, Docket No. FDA–2010–D– final formulation testing has been and (j)) to clarify how the testing should 0509–0004). In light of this submission, maintained in accordance with be conducted. FDA reassessed the input slit bandwidth established written specifications. This We are concerned that manufacturers parameters and concluded that ≤5 nm requirement will enable FDA to more conducting the SPF test procedure may will be sufficient for the broad spectrum efficiently monitor compliance. Failure be relying on determinations of the procedure. Although decreasing to keep required records of final initial minimal erythema dose of bandwidth improves the ability to formulation testing will render a unprotected skin (MEDu) generated too resolve closely spaced peaks (i.e., the product whose labeling relies on that far in advance of testing the sunscreen spectral resolution), this is not a testing adulterated under section product. The current regulation in significant consideration for in vitro 501(a)(2)(B) of the FD&C Act. Without § 201.327(i)(5) addresses four different broad spectrum testing of sunscreen recordkeeping, there is no assurance determinations of MED for each test products because transmittance/ that a sunscreen drug product has the subject: (1) An initial MED for absorbance curves for sunscreen

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products are typically smooth with no solar simulator. We propose to resolve insect repellent active ingredients are individual sharp peaks. Accordingly, we this error by clarifying that the exempt from registration because EPA propose to revise § 201.327(j)(1)(iv) to handheld radiometer measures the solar has determined they present minimum require that spectrometer input slits be simulator radiation intensity rather than risk potential to humans (Ref. 189). ≤ set to provide a bandwidth that is 5 the emission spectrum. Finally, we have Sunscreen-insect repellent nm. proposed edits to certain provisions combination products have been Establishing standardized testing describing final formulation testing marketed in the United States since procedures for sunscreen products and procedures to clarify our long-standing before the OTC review began, but they basing the products’ labeling on this intention that these provisions of the have not previously been addressed in testing not only helps assure the safety test are requirements, not merely the rulemaking for the OTC sunscreen and effectiveness of each product, it also suggestions. monograph (72 FR 7941 at 7943). Both provides consumers with consistent FDA and EPA have historically declined information about the sun protection E. Proposed Status of Sunscreen-Insect Repellent Combination Products to object to the marketing of these properties of sunscreen products across products pending the issuance of a final brands, which in turn facilitates 1. Background sunscreen monograph, provided that the consumer comparisons when selecting Sunscreen-insect repellent sunscreen active ingredient(s) is listed products. Accordingly, we propose to in the stayed final monograph and the delete the provision in § 352.77 (21 CFR combination drugs are products used on human skin that contain both a insect repellent component is registered 352.77) addressing test modifications or with the EPA (79 FR 7941 at 7943). In alternative testing procedures. Section sunscreen drug component and an 2011, FDA issued a draft enforcement 352.77 indicates that such test insect repellent component. A list of guidance intended for manufacturers modifications or alternative testing insect repellent products on the EPA who market OTC sunscreen products procedures require submission of a website identified a number of such without an approved application, which petition in accordance with § 10.30 (21 products as of November 2017 recommended that manufacturers of CFR 10.30). The proposed removal of (including multiple products within a 47 sunscreen-insect repellent combination § 352.77 does not alter the existing single brand line). Among those products should comply as closely as ability of a firm or individual to petition products, the majority contained either possible with FDA’s sunscreen testing the Agency to amend the monograph N,N-Diethyl-meta-toluamide (also called and labeling requirements in § 201.327. (see §§ 330.10(a)(12) and 10.30) to DEET) or IR3535 as the insect repellant, change the conditions that apply to and a few contained oil of citronella as This guidance was finalized in May products marketed under its provisions, the insect repellent. Combination insect 2018 (Ref. 1). such as to modify testing procedures for repellent-sunscreen products have been In the Federal Register of February all products having some particular set marketed in a variety of dosage forms 22, 2007 (72 FR 7941), FDA issued a of characteristics. Rather, the proposed (see section IX.A for a discussion of notice seeking public comments on deletion will clarify that the sunscreen dosage forms), with labeled SPF levels sunscreen-insect repellent combination monograph does not permit variation for ranging from 15 to 30 (Ref. 187). Some products, and, in particular, whether individual products from the products are also labeled as water FDA should amend the OTC sunscreen standardized testing procedures that are resistant or very water resistant (Ref. monograph to add conditions for monograph conditions, because such 187). The products are generally labeled marketing insect repellent-sunscreen variation could undermine important for use without regard to age (Ref. 187). drug products (FDA Call for Data or call values supported by standardization. FDA regulates sunscreens as drug for data). The call for data summarized We are also proposing to correct a products under the FD&C Act, and EPA the regulatory status and history of both minor inaccuracy in the existing concurrently regulates insect repellents sunscreens and insect repellents, and regulatory language describing testing as pesticides under FIFRA.48 FIFRA sought public input on a number of procedures. Specifically, defines a ‘‘pesticide’’ in relevant part as issues (see table 6). On that same date § 201.327(i)(1)(ii)(C) currently states that ‘‘any substance . . . intended for (February 22, 2007, 79 FR 7979), EPA ‘‘emission spectrum must be determined repelling . . . any pest,’’ including published a similar notice announcing using a handheld radiometer.’’ As insects (7 U.S.C. 136)(u)). Before they that it was also seeking information to written, this statement is inaccurate can be marketed, most skin-applied determine how insect repellent- because a handheld radiometer cannot insect repellents must be registered by sunscreen combination products should determine the emission spectrum of a EPA, although a few plant-derived be regulated. TABLE 6—KEY ISSUES AND INFORMATION REQUESTS IN FDA’S 2007 CALL FOR DATA

General issue Key concerns and information requests

Possible manufacturing conflicts ...... Requested information about whether there are known conflicts between FDA and EPA manufacturing requirements and, if so, how to resolve them. Asked how FDA should address EPA-registered insect repellents in finalizing the OTC sunscreen monograph; which re- quirements should FDA retain, revise, or eliminate? Inquired about manufacturer testing of sunscreen-insect repellent combination products and whether any problems were encountered. Possible formulation conflicts ...... Requested comments on the significance of published research suggesting a potential formulation conflict.

47 EPA Product List (Ref. 187); a similar list of scabicides intended to control parasites on humans) Department of Health, Education and Welfare Food insecticide products on the National Pesticide or animal drugs (e.g., pesticide products for oral and Drug Administration,’’ (available at https:// Information Center (NPIC) website produced similar administration to animals) (7 U.S.C. 136 et seq.); see www.fda.gov/aboutfda/partnershipscollaborations/ results (Ref. 188). also ‘‘MOU 225–73–8010 Memorandum of memorandaofunderstandingmous/domesticmous/ 48 Some insect repellents are also regulated by Understanding Between the Environmental ucm115873.htm (accessed April 17, 2018). FDA as human drugs (e.g., pediculicides and Protection Agency and the United States

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TABLE 6—KEY ISSUES AND INFORMATION REQUESTS IN FDA’S 2007 CALL FOR DATA—Continued

General issue Key concerns and information requests

Possible labeling conflicts between OTC Labeling differences noted: sunscreen monograph and EPA reg- • FDA uses ‘‘warning’’; EPA uses ‘‘caution’’ (and only uses the word ‘‘warning’’ to indicate toxicity levels). istration requirements. • Many differences in required warning/caution section headings. Note: Since publication of the call for • Directions for sunscreen use call for liberal application and frequent reapplication; EPA directions may limit where data, FDA has established additional and how to apply product and restrict frequency of application. labeling regulations for certain OTC Asked whether different directions for use can be integrated without leading to improper application, overexposure to in- sunscreen products marketed without sect repellent, and/or underexposure to sunscreen. approved applications. However, the FDA requires the outside container or wrapper of the retail package or the immediate container label to list all active and labeling concerns expressed in the call inactive ingredients (see section 502(e)(1)(A)(iii) of the FD&C Act; § 201.66(c)). EPA requires listing of the percentage of for data remain relevant. each active ingredient, and the total percentage of all ‘‘inert’’ or ‘‘other’’ ingredients, in the pesticide. Inert ingredients are not required to be identified individually on the product except in certain cases (in which case all inert ingredients are listed). Asked whether there is a way to label combination sunscreen-insect repellent drug products in a way that satisfies both the requirements of the FD&C Act and the FIFRA, and whether ‘‘inert’’ ingredients under the FIFRA are equivalent to ‘‘inactive’’ ingredients under the FD&C Act. Safety issues ...... More safety data needed given published animal studies indicating increased absorption of DEET and various sunscreens active ingredients when the components are combined. Asked for more safety data on combined products. Requested data on whether increased absorption of a sunscreen ingredient occurs when combined with an insect repel- lent. Information needed about incidence of skin irritation from combination products. Effectiveness issues ...... Requested information on: • Possible effects of insect repellent on sunscreen SPF; possible decreased sunscreen efficacy or increased expo- sure to insect repellent without greater efficacy resulting from inconsistent reapplication intervals. • Potential chemical or physical incompatibilities between particular sunscreens and insect repellents. • Potential need to specify minimum SPF for these combinations. • Any potential performance benefits of these combination products other than convenience. • Possible adjustments to formulations to minimize application time disparities.

2. FDA’s Evaluation of Sunscreen-Insect conclusions are detailed in the than using separate products. Two Repellent Combination Products discussion that follows. comments stated that properly a. Public comments on the 2007 call formulated, tested, and labeled, FDA has reviewed the comments for data. FDA received six submissions combination products are better than submitted in response to FDA’s and in response to the 2007 call for data. the unpredictable effects that could EPA’s calls for data, as well as pertinent None of the comments included arise when consumers use two different scientific literature and publicly substantive data, although some cited products. Regarding safety, one available EPA regulatory documents. published scientific and medical comment asserted various flaws in the Based on that review, we have literature, which is addressed in the studies cited in the call for data that tentatively concluded that sunscreen- following section of this document. Five questioned the safety of these insect repellent combination products, of the six comments were from combination products. (These studies as a class, are not GRASE (i.e., are manufacturers or a trade association. are discussed in section IX.E.2.d.) Category II) and are misbranded because Industry comments generally favored In general, the comments that we conflicting labeling requirements for retaining joint regulation between EPA their sunscreen and insect repellent and FDA (perhaps with enhanced received in response to the 2007 call for components cannot be reconciled to coordination and information-sharing) data were not accompanied or create labeling that will sufficiently and amending the stayed OTC corroborated by data. Although the ensure safe and effective use of the sunscreen monograph to address comments did not identify further sunscreen component, as well as sunscreen-insect repellent concerns relating to product adequate directions for use as a combinations. Several industry manufacturing or formulation, they did sunscreen, as required by section 502(f) comments claimed there was an absence not adequately address FDA’s concerns of the FD&C Act. Also, if we did not of conflicting requirements relating to about safety, effectiveness, and labeling have this labeling concern, we would manufacturing, formulation, and/or of these products. FDA renews its still tentatively determine that available labeling. Others suggested approaches request for data to support labeling and data regarding the safety and for minimizing labeling conflicts, such safety for sunscreens with insect effectiveness of these products for their as permitting exemptions to FDA’s Drug repellent added. use as sunscreens are insufficient to Facts labeling requirements to b. Pesticide-related information. classify these sunscreen products as accommodate EPA-required Pesticides that are or have been used in GRASE for such use (i.e., Category III). information, or placing FDA- and EPA- combination products that also contain Specifically, evidence suggests that required information in separate areas of sunscreens include DEET, IR3535, and interactions between some sunscreen the label. The remaining comment was oil of citronella. In evaluating active ingredients and insect repellents submitted by a medical association that combination insect repellent-sunscreen may decrease safety by increasing opposed continued marketing of products for the purposes of this rule, systemic absorption of one or both sunscreen-insect repellent products, FDA defers to EPA’s expertise and components, and potential synergistic emphasizing concerns about children’s authority regarding insect repellent effects on the efficacy of sunscreen exposure to DEET. Industry comments ingredients. We have not independently active ingredients apparently have not favoring the continued marketing of evaluated these pesticides, but instead been studied. Although the available combination sunscreen-insect repellent have focused on potential sunscreen- data are limited and not conclusive, drug products also contended that insect repellent ingredient interactions they give rise to questions about the combining sunscreen and insect and the feasibility of effectively labeling safety and effectiveness of these repellent ingredients in a single product these combination products for their use products. Our reasons for these tentative is more convenient and cost-effective as sunscreens.

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As of June 2017, DEET was by far the DEET does not pose a significant health regulations in subpart A of part 201; the most commonly used insect repellent. risk to the U.S. population.50 ‘‘Drug Facts’’ format and other OTC According to the EPA Product list, the IR3535 is classified by EPA as a drug labeling requirements in subpart B amount of DEET in combination biopesticide because it is biochemically, of part 201; and the sunscreen-specific sunscreen-insect repellent products functionally identical to beta-alanine, a labeling requirements that apply to ranged from 10 to 20 percent. DEET naturally occurring substance that sunscreens marketed without an product labels recommend that users repels insects (Ref. 194). IR3535 is approved NDA, including those based avoid over-application, use just enough classified in Toxicity Category IV on the current requirements for SPF and repellent to cover exposed skin and/or (practically nontoxic) for acute oral, broad spectrum testing in § 201.327. The clothing, and not apply to hands or near dermal, and inhalation toxicity and labeling of registered insect repellents is Category III (slightly toxic) for eye the eyes or mouth of young children subject to EPA labeling requirements irritation (Ref. 195). Overall, EPA has (Ref. 190). DEET-containing products under FIFRA (40 CFR 156), as well as assessed IR3535 as not harmful when specific language specified in individual listed on the EPA website in 2017 had ingested, inhaled, or used on skin (Ref. product registration documents. concentrations ranging from 5 percent to 195). Eye irritation could occur if the Although the FDA and EPA labeling 98 percent and provided protection chemical enters a person’s eyes (Ref. requirements for nonprescription from mosquitos for 2 to 12 hours, with 195). IR3535 is used at concentrations of sunscreens and registered pesticides many products having protection times 7.5 percent to 20 percent in a popular cover some of the same information of 4 hours or more (Ref. 187). The line of sunscreen-insect repellent (such as ingredient lists, net quantity American Academy of Pediatrics combination products (EPA Product statements, and warnings/precautions), recommends that repellents should List) (Ref. 187). Products containing there is considerable variation in the contain no more than 30 percent DEET IR3535 identified on EPA’s website in language, format, and placement of when used on children, and that insect summer 2017 had concentrations common label elements between the repellent should not be used on ranging from 7.5 percent to two Agencies, while other elements do children younger than 2 months (Ref. approximately 20 percent and listed not overlap. 191). protection time against mosquitoes of 2 Furthermore, both Agencies limit the EPA classifies the acute toxicity of to 8 hours (EPA Product List) (Ref. 187). degree to which a drug manufacturer or insect repellents and other pesticides Oil of citronella is a plant-derived pesticide registrant may depart from the into one of four toxicity categories biochemical insect repellent (72 FR prescribed text, format, and/or location of required labeling elements. This is (ranging from Category I, highly toxic, to 7979 at 7981). Depending on its source, particularly true for the wording and Category IV, practically nontoxic) (see it may be categorized as ‘‘Ceylon’’ type or ‘‘Java’’ type. It is currently listed by format of ‘‘drug facts’’ information for 40 FR 156.62). DEET is classified in EPA as a minimum risk pesticide OTC drugs (see § 201.66). Similarly, Category III based on EPA’s review of (registration generally not required if EPA regulations state that although a available animal studies, indicating formulated only with EPA-permitted registrant may choose to place non- slight acute toxicity for acute oral, inert ingredients and not labeled as FIFRA-required information on a dermal, ocular, and inhalation tests in effective against disease-causing pests) pesticide label, it may not replace, animals, and low acute toxicity for the (40 FR 152.25(f)). Oil of citronella is also obscure, conflict with, or supersede the human health risk assessment (Ref. an approved food additive for use as a FIFRA-required text (Ref. 199). 192). Although DEET is registered for flavoring agent in foods and beverages The intended uses of sunscreens and use in humans of any age, adverse (Ref. 196). EPA has designated oil of insect repellents are quite different, as events related to DEET toxicity have citronella as Toxicity Category III are the associated labeling requirements; been documented and these events (slightly toxic) for acute oral toxicity in particular, the instructions for using primarily relate to the central nervous (Java type only), dermal toxicity, dermal the two types of products are different. system. As summarized by Katz et al., irritation, and acute eye irritation (both Required labeling for OTC sunscreens DEET has been associated with seizures types), and Category IV (practically marketed without approved NDAs calls and other central nervous system nontoxic) for acute oral toxicity (Ceylon for reapplication at least every 2 hours symptoms, cardiovascular symptoms, type) and acute inhalation (Ref. 197). (see § 201.327(e)(3) through (e)(4)). The and topical and allergic symptoms (Ref. The National Pesticide Information duration of protection for insect 193). Most reported cases of adverse or Center (NPIC) fact sheet on oil of repellents varies according to the active lethal events involved overuse or citronella states that oil of citronella ingredient and strength. Based on otherwise incorrect use of the product products should not be used on children information from the EPA product list, (Ref. 193), and EPA concluded that less than 6 months old (Ref. 198). many insect repellent-sunscreen available data were insufficient to c. Disparities in required labeling of products provide protection against identify DEET as the cause of the sunscreens and insect repellents. FDA mosquitoes and/or ticks for more than 2 reported adverse events (Ref. 192). EPA and EPA regulate the format and content hours, and some provide protection for is currently in the process of updating of the labeling of nonprescription as many as 6 to 10 hours. EPA has stated its registration of a number of older sunscreen products and pesticides, that it is ‘‘concerned about consumer pesticides, including DEET, and is respectively. FDA regulations on use of products that contain sunscreens deferring decision on the regulatory nonprescription sunscreen labeling and DEET, since directions to reapply status of combination DEET/sunscreen include the general drug labeling generally and frequently may promote products as described in the EPA Call greater use of DEET than needed for 50 pesticidal efficacy and thus pose for Data.49 However, EPA has stated that Id. In June 2014, EPA issued an interim review of DEET and did not identify any specific new unnecessary exposure to DEET.51 The concerns. The proposed interim registration review Centers for Disease Control and 49 DEET 2014 reregistration interim review final decision became final on September 24, 2014. DEET decision (EPA–HQ–OPP–2012–0162) (available at 2014 reregistration interim review final decision Prevention (CDC) advises consumers https://www3.epa.gov/pesticides/chem_search/reg_ (EPA–HQ–OPP–2012–0162) (available at https:// actions/reregistration/red_PC-080301_1-Apr-98.pdf www.regulations.gov/document?D=EPA-HQ-OPP- 51 DEET 2014 reregistration interim review final (accessed April 17, 2018). 2012-0162-0012 (accessed April 17, 2018). decision, supra note 49, v.

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that ‘‘products that combine sunscreen establishment numbers (40 CFR review raise potential safety concerns and repellent are not recommended, 156.10(a)). about products that combine sunscreen because sunscreen may need to be • FDA labeling for sunscreens uses and insect repellent active ingredients. reapplied more often and in larger the word ‘‘warning’’ (see §§ 201.66(c)(5) The available data suggest that the amounts than needed for the repellent and 201.327(d)), while the EPA dermal penetration and systemic component to provide protection from requirements specify that pesticide absorption of at least one combination biting insects.’’ (Ref. 200). Similarly, the products that, like DEET, IR3535, and of a sunscreen active ingredient and an American Academy of Pediatrics oil of citronella, meet the criteria of insect repellent is increased when both advises consumers not to use products Toxicity Category III or IV as the highest are present. that combine DEET with sunscreen, in category by any route of exposure bear There have been some studies part because ‘‘[t]hese products can on the front panel either no signal word assessing the penetration of DEET and overexpose your child to DEET because or only the signal word ‘‘CAUTION’’ (40 the effects of DEET combined with the sunscreen needs to be reapplied CFR 156.64). In EPA labeling the word sunscreen (particularly the active often’’ (Ref. 201). Additionally, DEET is ‘‘WARNING’’ is used as a signal word ingredient oxybenzone) on dermal approved for use on children with no only for toxicity category II, which is a penetration. Ross et al. tested for age restriction (Ref. 202), whereas FDA higher toxicity category than that synergistic effects between DEET and labeling states ‘‘[bullet] children under applicable to any insect repellent oxybenzone using an in vitro mouse 6 months of age, ask a doctor’’ (see ingredients used in sunscreen-insect skin diffusion model and showed § 201.327(e)(1)(iv)). repellent combination products (40 CFR substantial penetration of a 20 percent 156.64(a)(2)). DEET standard in ethanol, while The recommended manner of • application also differs for sunscreens FDA labeling uses the term penetration of sunscreen active and insect repellents. For example, the ‘‘directions’’ (see §§ 201.66(c)(6) and ingredients was not found (Ref. 205). directions on the label for all insect 201.327(e)), while EPA regulations use Despite a lower DEET content (10 repellent products containing DEET say the term ‘‘directions for use’’ (see 40 percent), a commercially marketed CFR 156.10(i)(2)). to apply just enough to cover exposed sunscreen formulation had a 6-fold • FDA calls for ingredients to be skin, and avoid over-application (Ref. more rapid detection and a 3- to 4-fold listed as ‘‘active’’ and ‘‘inactive’’ (see 190), whereas the labeling of greater penetration of DEET than the 20 § 201.66(b) through (c)), while EPA percent standard. Other diffusion tests nonprescription sunscreens marketed labeling uses the term ‘‘inert’’ or ‘‘other’’ without approved NDAs calls for liberal using pigskin or artificial membranes instead of ‘‘inactive’’ for all non- and various combinations of DEET and or generous application (see pesticide ingredients (40 CFR 156.10(g)). § 201.327(e)(1)(ii)). The EPA-mandated oxybenzone in different media Given the extent of the disparities suggested an enhancing effect on dermal directions on the labels of DEET discussed above, FDA tentatively penetration of both DEET and products also state, ‘‘Do not apply near concludes that attempting to merge the oxybenzone (Refs. 206 and 207). The eyes and mouth; apply sparingly around required labeling for monograph same investigators obtained similar ears; do not use under clothing’’ (Ref. sunscreens and insect repellents in a results in a later in vitro study using 190). Such statements are potentially way that would comply with both human skin (Ref. 207). troublesome from the standpoint of sun Agencies’ requirements and permit Kasichayanula et al. assessed the protection in light of surveillance data adequate consumer understanding and dermal absorption of DEET and from Australia, which suggest that the proper use would be impracticable. In oxybenzone using an in vivo piglet incidence of certain skin cancers is this regard, we specifically disagree model, in which samples were collected more frequent on highly exposed areas with comments made in response to the from plasma, urine, and under the skin. of the body such as ears and the backs 2007 FDA Call for Data suggesting that Their results indicated that the of hands (Refs. 203 and 204). The CDC acceptable ‘‘merged’’ labeling could be enhanced dermal penetration evidenced advises consumers who need protection crafted by varying the OTC sunscreen in the in vitro studies translated to from both sun and insects to apply drug facts to include insect-repellent- increased systemic exposure to both sunscreen product first, followed by an related information, and/or by providing oxybenzone and DEET (Refs. 208 and insect repellent (Ref. 200). EPA-required labeling outside the drug 209). Finally, a study by Yiin et al. Additional disparities in the content facts box. We are particularly concerned suggests that enhanced systemic and format of labeling elements for that consumers would be confused by absorption would also occur in humans sunscreens and registered insect the juxtaposition of two sets of different (Ref. 210). Yiin et al. used human repellents include the following: and, in some cases, contradictory urinary metabolites of DEET and • EPA pesticide labeling includes information in the labeling about these oxybenzone to evaluate the mutual required elements that generally must products’ dual intended uses. We are enhancing effect on absorption of these appear on the front panel of the label, also concerned that the sheer amount of ingredients and concluded that their such as the ingredient statement (40 required information would result in findings confirm that concurrent use of CFR 156.10(g)(2)), specified signal word crowded, difficult-to-read labels lacking DEET-containing insect repellent and such as ‘‘CAUTION’’ (40 CFR 156.64), in the clarity and prominence of oxybenzone-containing sunscreen and child hazard warning (40 CFR important safety and use information results in the enhancement of dermal 156.66), which could crowd or detract that are both required by FDA absorption of DEET when insect from drug information required to regulations and vital to consumer repellent (DEET) was applied first and appear on the principal display panel comprehension. We solicit comment then covered by sunscreen (Ref. 210). for drugs (see § 201.60 (‘‘The principal and data about how to reconcile the The study authors suggested that display panel shall be large enough to labeling of suncreens and insect placing repellent spray on top of accommodate all the mandatory label repellents such that a combined product sunscreen lotion with no mixing seems information required to be placed could meet FD&C Act requirements for to be the best approach to diminish thereon by this part.’’)). Other labeling OTC sunscreen drugs. DEET penetration through the skin. elements that only EPA requires include d. FDA’s review of published medical Although insect repellents and registration numbers and manufacturing literature. The results of FDA’s literature sunscreens are designed to exert their

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protective effects on the surface of the would affect the determined SPF value addressed by further studies on both skin, the studies described above of combination sunscreen-insect combinations of individual sunscreen suggest that combining a sunscreen and repellent products. Montemarano et al. and insect repellent ingredients and insect repellent in a single product may reported a reduction in sunscreen final formulations. result in unintended systemic exposure efficacy because of concomitant use Existing data indicates there is a risk to the sunscreen ingredient oxybenzone with insect repellent. However, in that of systemic absorption of insect and the insect repellent ingredient study, the sunscreen and insect repellent and/or a sunscreen active DEET. We acknowledge the study repellent ingredients were applied ingredient when both are present. limitations cited by comments to the separately and were not part of a Additional data would be needed to FDA Call for Data, and that in vitro combination product (Ref. 211). identify any interactions between diffusion studies have their limitations With respect to efficacy, we recognize specific sunscreen active ingredients in terms of reflecting clinical use. We that the testing required by § 201.327 and insect repellents, in particular, to also note that many of the studies tested (both the current regulation and the characterize any enhancement of skin formulated commercial products with regulation if amended as proposed penetration and/or systemic absorption multiple sunscreen ingredients and elsewhere in this proposed rule) to if the resulting data presents safety or excipients for which details were not support labeled SPF levels and other effectiveness concerns. As stated above, given, and it is unclear how this may efficacy claims that may be made for FDA would need adequate human have influenced the results. Although certain OTC sunscreen products could absorption studies, such as a MUsT, as we, therefore, do not view these data as potentially mitigate concerns about the part of the clinical safety assessment (for conclusory, we have determined that impact of insect repellent active more discussion on assessment of they raise a valid safety concern that ingredients on sunscreen effectiveness. dermal absorption of sunscreen active warrants a tentative conclusion that, However, we are not aware of any data ingredients using MUsT, see section even if one could overcome the evaluating the reliability of SPF testing VII.B.4). The effectiveness of sunscreen- misbranding and associated safety and for sunscreen formulations that contain insect repellent combination products is effectiveness concerns created by the insect repellent ingredients. There also also a continuing concern. For all of inconsistent application directions for is the possibility that increasing the those reasons, we tentatively determine sunscreens and insect repellants, there amount of the sunscreen active that these products are not GRASE for would not be sufficient evidence to ingredient to compensate for any loss in nonprescription sunscreen use. We conclude that combination sunscreen efficacy because of the presence of the solicit comment on this tentative and insect repellent products are insect repellent could result in determination. unnecessarily high exposure to the GRASE for sunscreen use without X. Proposed Actions To Effectuate sunscreen active ingredient. For these further investigation. Lifting of Stay and Harmonize Regarding future investigations that additional reasons, we tentatively Impacted Regulations could assist FDA in determining conclude that even if other concerns whether these products have sufficient could be overcome, there is not In the 2011 L&E Final Rule, FDA evidence of safety to be GRASE for use currently sufficient evidence to explained that although we were not yet as sunscreen, we are not aware of any conclude that combination sunscreen- lifting the stay on the 1999 final data that define the extent of systemic insect repellent products are GRASE for monograph, the provisions set forth in exposure to either DEET or oxybenzone use as sunscreens. We solicit comment the L&E Final Rule reflected the that would occur with maximal on the data needs identified above and Agency’s position on the appropriate exposure to a sunscreen-insect repellent tentative conclusions, including testing and labeling of sunscreen combination product. There also are few supporting data and analysis. We also products that were previously identified data from which to assess whether there solicit data and information to address as falling within the Stayed 1999 Final would be a similar enhancement of skin these data needs. Monograph (76 FR 35620 at 35621). We penetration for other combinations of explained that § 201.327 would 3. Conclusion sunscreen and insect repellent active therefore supersede the prior approach ingredients. Moreover, without adequate FDA tentatively concludes that the to labeling and effectiveness testing human absorption studies under inherent disparity in labeling described in the never-effective maximal use conditions of particular requirements that apply to sunscreens provisions of part 352, subparts C sunscreen-insect repellent combinations marketed under the OTC monograph and D. (i.e., a MUsT, as discussed in section and insect repellents prevent the We are now proposing to lift the stay VII.B.4), it is difficult to evaluate creation of labeling that will sufficiently on the 1999 final monograph (21 CFR potential risks associated with the use of ensure safe and effective use of the part 352) while making certain changes such combination products. Because of sunscreen component of sunscreen- in its provisions. To fully effectuate this the potential synergistic interaction insect repellent combination products, proposal, we are proposing several between the sunscreen active ingredient particularly in connection with duration harmonizing revisions to part 352 and and the insect repellent active of action. We also conclude that these § 201.327. These changes remove certain ingredient, human absorption data for conflicting requirements prevent these provisions from part 352 that were the individual components would not products from having adequate superseded by the 2011 L&E Final Rule provide adequate data to estimate the directions for use as a sunscreen, and and, where applicable, replace them level of systemic absorption. Likewise, thus these products would be with appropriate cross references to the in vitro data would not be able to misbranded under section 502(f) of the applicable testing and labeling provide a reliable estimate of the FD&C Act. In addition, even if these provisions in § 201.327, as we propose systemic exposure that would occur issues could be overcome, existing to amend these regulations in this with such products’ use. safety concerns about potential document. We also have made minor In terms of sunscreen active enhanced systemic absorption resulting revisions in parts 347, 352 and ingredient effectiveness, we have little from combining individual sunscreen § 201.327 to improve readability and to data from which to determine whether active ingredients and insect repellent correct certain typographical errors and the presence of an insect repellent ingredients would also need to be erroneous internal cross references.

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We are also proposing revisions to Finally, we propose to add to remaining in retail outlets. Our current certain provisions describing § 310.549 new characteristics that thinking on implementation is informed requirements for products containing would render a product a new drug. in part by our understanding there are both sunscreen active ingredients and These characteristics include: (1) no currently marketed sunscreen skin protectant active ingredients to Containing the ingredients we propose products that contain the active avoid duplication between § 201.327 to classify as categories II and III (see ingredients we propose here as Category and part 352 and to harmonize the sections VIII.B–C); (2) being labeled, II. We solicit comment on this proposed requirements set forth in those represented, or promoted for use as a approach. provisions. As in the past, the proposed combined sunscreen-insect repellant XIII. Preliminary Economic Analysis of sunscreen monograph would include (see section IX.E); (3) failing to comply Impacts conditions under which a single with provisions relating to maximum product could include certain sunscreen SPF values and broad spectrum A. Introduction active ingredients as well as certain requirements (see section IX.B); and (4) ingredients determined to be GRASE for failing to conform to certain other We have examined the impacts of the use in skin protectants under part 347 sunscreen formulation and dosage form proposed rule under Executive Order (see proposed § 352.20(b), as well as conditions (see sections IX.A and D). 12866, Executive Order 13563, Executive Order 13771, the Regulatory current § 347.20(e) (21 CFR 347.20(e)). XI. Comment Period Current § 201.327(h) allows for such Flexibility Act (5 U.S.C. 601–612), and products to combine certain labeling We are providing a comment period the Unfunded Mandates Reform Act of statements applicable to each ingredient of 90 days (see DATES). FDA will also 1995 (Pub. L. 104–4). Executive Orders in the product to eliminate duplicative consider requests to defer further 12866 and 13563 direct us to assess all words or phrases. The stayed provisions rulemaking with respect to a specific costs and benefits of available regulatory of part 352 contain similar allowances sunscreen active ingredient to allow the alternatives and, when regulation is for products that contain both sunscreen submission of new safety and/or necessary, to select regulatory and skin protectant active ingredients, effectiveness data to the record if such approaches that maximize net benefits but also outline more detailed requests are submitted to the docket (including potential economic, requirements for presenting such a within the initial 90-day comment environmental, public health and safety, product’s statement of identity, period. FDA will review all data and and other advantages; distributive indications, warnings, and directions. information submitted to the record in impacts; and equity). Executive Order conjunction with all timely and We propose to relocate the labeling 13771 requires that the costs associated complete requests to extend. In requirements for such products from with significant new regulations ‘‘shall, assessing whether to extend the § 352.60 to § 201.327(h), thereby to the extent permitted by law, be offset comment period to allow for additional consolidating labeling conditions for by the elimination of existing costs time for studies to generate new data these products in one section of the associated with at least two prior and information, FDA will consider the regulations. We also propose to retain regulations.’’ We believe that this data already in the docket along with compliance with these labeling proposed rule is a significant regulatory any information that is provided in any provisions as a monograph condition for action as defined by Executive Order requests to extend. FDA will determine sunscreen/skin protectant products 12866. whether the sum of the data, if timely The Regulatory Flexibility Act under both parts 352 (the sunscreen submitted, is likely to be adequate to requires us to analyze regulatory options monograph) and 347 (the skin provide all the data that are necessary that would minimize any significant protectant monograph) by incorporating to make a determination of general impact of a rule on small entities. cross references to § 201.327(h) in recognition of safety and effectiveness. § 352.20(b)(4), and § 352.60, and Because many sunscreen manufacturers incorporating cross references to XII. Proposed Effective/Compliance are small entities and the one-time costs §§ 352.20 and 352.60 in §§ 347.20(e), Dates of the proposed rule represent a and 347.60. The proposed effective date of final significant fraction of annual revenue to Additionally, we propose to regulations resulting from the proposals sunscreen manufacturers, we find that consolidate under new § 310.549 (21 described in this rulemaking is the proposed rule will have a significant CFR 310.549) certain properties that November 26, 2019 (see FD&C Act economic impact on a substantial render an OTC drug product offered for section 586E). We recognize that number of small entities. use as sunscreen a new drug for which industry will need time after The Unfunded Mandates Reform Act an approved NDA is required prior to publication of any final regulations to of 1995 (section 202(a)) requires us to marketing. Section 310.545 (21 CFR comply with their provisions. To allow prepare a written statement, which 310.545) currently contains several such for orderly implementation of final includes an assessment of anticipated provisions addressing specific regulations and help assure continued costs and benefits, before proposing ingredients and efficacy claims. We product availability to consumers, we ‘‘any rule that includes any Federal propose to relocate these provisions would not expect full compliance with mandate that may result in the from § 310.545 to § 310.549. In addition, such final regulations for units of expenditure by State, local, and tribal in the interest of completeness, we are sunscreen product initially introduced governments, in the aggregate, or by the clarifying in § 310.549 that labeling a or initially delivered for introduction private sector, of $100,000,000 or more product with claims that it decreases the into interstate commerce, until 1 year (adjusted annually for inflation) in any risk of skin cancer or early skin aging after the effective date of the final rule. one year.’’ The current threshold after caused by the sun if that product has an We also would not expect full adjustment for inflation is $150 million, SPF of less than 15 when tested in compliance, even after that date, for using the most current (2017) Implicit accordance with § 201.327(i) and/or units of product that were initially Price Deflator for the Gross Domestic does not pass the broad spectrum test in introduced or initially delivered for Product. This proposed rule would § 201.327(j) renders the product a new introduction into interstate commerce result in an expenditure in any year that drug. before that date, such as those meets or exceeds this amount.

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We have developed a comprehensive containing active ingredients about observations in final formulation preliminary regulatory impact analysis which safety questions remain, less testing. that assesses the impacts of the exposure to sunscreen products labeled Table 7 summarizes the costs and proposed rule. We present a summary of with potentially misleading sun benefits of the proposed rule, if this analysis below. protection information, increased finalized. The annualized benefits of the proposed rule, if finalized, would range B. Summary of Costs and Benefits consumption of products with better UVA protection, less exposure to from $0.00 million to $3.72 million at a If finalized, the proposed rule would flammable spray sunscreens, and less 7 percent discount rate and from $0.00 update and make effective regulations to exposure to spray and powder million to $3.62 million at a 3 percent ensure the safety and effectiveness of sunscreen products posing inhalation discount rate. Our primary estimate of sunscreen products marketed under the risks. Consumers would also experience annualized benefits would equal $0.91 OTC drug monograph. The rule would transaction cost savings. The costs of the million at a 7 percent discount rate and update sunscreen product labeling $0.88 million at a 3 percent discount rule to sunscreen manufacturers include standards, address the safety of rate. The annualized costs of the administrative costs, costs to fill data sunscreen active ingredients, revise and proposed rule, if finalized, would range clarify our expectations for testing and gaps for active ingredients and powder from $15.57 million to $75.84 million at recordkeeping by entities that conduct dosage forms, product formulation a 7 percent discount rate and from sunscreen testing, and address other testing costs, and costs to reformulate $12.40 million to $60.42 million at a 3 sunscreen safety or efficacy concerns, and relabel sunscreen products. Finally, percent discount rate. Our primary like combination sunscreen-insect testing entities would incur estimate of annualized costs would be repellents and alternative dosage forms. recordkeeping costs if they do not $47.55 million at a 7 percent discount Consumers would benefit from less already maintain adequate records of rate and $37.79 million at a 3 percent exposure to sunscreen products testing equipment, methods, and discount rate.52

TABLE 7—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE

Units Category Primary Low High Discount Period Notes estimate estimate estimate Year rate covered dollars (%) (years)

Benefits: Annualized Monetized ($m/ $0.91 $0.00 $3.72 2017 7 20 year). 0.88 0.00 3.62 2017 3 20 Annualized Quantified (mil oz/ 201.79 98.16 286.26 Increased use of products with year) 1. improved UVA protection. Annualized Quantified (mil oz/ 51.42 19.43 83.41 Less exposure to sunscreens year) 2. containing active ingredients about which safety questions remain. Annualized Quantified (mil oz/ 161.04 159.88 162.20 Less exposure to sunscreens with year) 3. potentially misleading sun pro- tection information. Annualized Quantified (mil oz/ 386.44 384.86 388.02 Less exposure to spray and pow- year) 4. der sunscreens posing inhala- tion risks.

Qualitative ...... Quicker responses to adverse events, improved inspections, and better protection of human subjects. Potential transaction cost savings re- lated to changes in the effort required to choose a sunscreen.

Costs: Annualized Monetized ($m/ 47.55 15.57 75.84 2017 7 20 year). 37.79 12.40 60.42 2017 3 20 Annualized Quantified.

Qualitative ...... Recordkeeping costs to testing entities that do not already maintain adequate records.

Transfers: Federal Annualized Mone- tized ($m/year).

52 The primary estimate of the costs is not the average of the lower bound costs and the upper bound costs.

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TABLE 7—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE—Continued

Units Category Primary Low High Discount Period Notes estimate estimate estimate Year rate covered dollars (%) (years)

From: To:

Other Annualized Monetized ($m/year).

From: To:

Effects: State, Local, or Tribal Government: None. Small Business: Some small businesses could exit the sunscreen market by discontinuing their products or going out of business. Wages: None. Growth: None. 1 Values represent the 2016 consumption of sunscreens that would provide improved UVA protection under the proposed rule. 2 Value represent the 2016 consumption of sunscreens that contain active ingredients about which safety questions remain. 3 Values represent the 2016 consumption of sunscreens with potentially misleading sun protection information. 4 Values represent the 2016 consumption of potentially inhalable spray sunscreens and powder sunscreens.

Table 8 shows the Executive Order would end after 20 years. We estimate Based on these costs, this proposed rule 13771 summary over an infinite time that this rule generates $29.85 million in would be considered a regulatory action horizon. In this analysis we assume that net annualized costs, discounted at 7 under E.O. 13771. the costs and cost savings of the rule percent, over a perpetual time horizon.

TABLE 8—E.O. 13771 SUMMARY TABLE [In $ millions 2016 dollars, over an infinite time horizon) 1

Primary Lower Upper Primary Lower Upper estimate bound bound estimate bound bound (7%) (7%) (7%) (3%) (3%) (3%)

Present Value of Costs ...... $456.33 $149.22 $730.46 $618.16 $201.53 $1,002.22 Present Value of Cost Savings ...... 0.00 0.00 0.00 0.00 0.00 0.00 Present Value of Net Costs ...... 456.33 149.22 730.46 618.16 201.53 1,002.22 Annualized Costs...... 29.85 9.76 47.79 40.44 13.18 65.57 Annualized Cost Savings ...... 0.00 0.00 0.00 0.00 0.00 0.00 Annualized Net Costs ...... 29.85 9.76 47.79 40.44 13.18 65.57 1 We assume that the benefits and costs of the proposed rule would diminish after 20 years. Negative values denoted in parentheses.

We have developed a comprehensive (44 U.S.C. 3501–3520). A description of burden of the collection of information Economic Analysis of Impacts that these provisions is given in the on respondents, including through the assesses the impacts of the proposed Description section of this document use of automated collection techniques, rule. The full preliminary analysis of with an estimate of the annual when appropriate, and other forms of economic impacts is available in the reporting, recordkeeping, and third- information technology. docket for this proposed rule (Ref. 63) party disclosure burden. Included in the Title: Sunscreen Drug Products for and at https://www.fda.gov/AboutFDA/ estimate is the time for reviewing OTC Human Use. ReportsManualsForms/Reports/ instructions, searching existing data Description: The proposed rule would EconomicAnalyses/default.htm. sources, gathering and maintaining the amend FDA’s current sunscreen labeling data needed, and completing and regulation (§ 201.327) and sunscreen XIV. Analysis of Environmental Impact reviewing each collection of products monograph (part 352) We have determined under 21 CFR information. regarding product labeling, testing, and 25.31(c) that this action is of a type that FDA invites comments on these recordkeeping requirements. We note does not individually or cumulatively topics: (1) Whether the proposed that existing regulations (e.g., current have a significant effect on the human collection of information is necessary § 201.327) already require SPF testing environment. Therefore, neither an for the proper performance of FDA’s and labeling. The information environmental assessment nor an functions, including whether the collections associated with current environmental impact statement is information will have practical utility; testing, labeling, and recordkeeping required. (2) the accuracy of FDA’s estimate of the requirements have previously been burden of the proposed collection of approved in accordance with the PRA XV. Paperwork Reduction Act of 1995 information, including the validity of under OMB control numbers 0910– This proposed rule contains the methodology and assumptions used; 0139, 0910–0717, and 0910–0755. For information collection provisions that (3) ways to enhance the quality, utility, more information about current are subject to review by OMB under the and clarity of the information to be regulations and their history, see the Paperwork Reduction Act of 1995 (PRA) collected; and (4) ways to minimize the Background and Scope sections of the

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proposed rule (sections III and IV, SPF or broad spectrum testing. Thus, we accordance with § 201.327(b)(1)(ii). respectively). The proposed rule would estimate that there are approximately 20 Proposed § 352.60(a) requires that the also amend parts 310 and 347. entities that conduct covered sunscreen product bear a statement of identity as While the proposed provisions are testing; we estimate these entities have set forth in § 201.327(h)(1). Proposed broadly consistent with current best approximately 20 lead clinical § 352.20(b)(4) requires that the product practices for testing conducted in investigators to whom certain must be labeled in accordance with human subjects and are not expected to information collection obligations (e.g., §§ 201.327(h) and 352.60. Proposed require significant changes by reputable reporting) may apply. § 347.60(a)(3) requires that the labeling and experienced testing establishments, of the product bear the statement of the proposed rule clarifies and confirms A. Labeling for Sunscreen Products and Associated Clinical Testing identity set forth in proposed the application of existing requirements § 352.60(a). to sunscreens and adds certain new The proposed rule includes third- We note that current regulations requirements, particularly for labeling party disclosure obligations for already include a requirement that OTC and recordkeeping. The purpose of responsible persons. The provisions products bear a statement of identity these changes is to help ensure that may also apply to entities to which the (see § 201.66). This proposed rule would sunscreen testing is conducted and responsible persons transfer their set forth the specific requirements just documented in a way that verifiably responsibilities under section described for sunscreen drug products provides for protection of human 201.327(a)(1) (‘‘transferees’’), depending and sunscreen drug products that also subjects and increases the reliability of on the scope of transferred obligations. contain skin protectant active the testing data that underlies sunscreen There are labeling-related information ingredients. We believe this analysis labeling, and to update the labeling collections (requirements include reflects the additional burden beyond requirements. certain information on product labels) current statement of identity and a related testing burden Description of Respondents: Affected requirements. entities include: (1) ‘‘responsible (requirements for certain clinical testing b. SPF value. Proposed § 201.327(b)(2) persons,’’ as defined in proposed to determine and support labeling requires, among other things, that the § 201.327(a); (2) entities to which the information). labeling display certain statements responsible person transfers its 1. Labeling-Related Information regarding the product’s SPF value; the obligations as permitted under proposed Collection and Burden § 201.327(a)(1) (e.g., contract statements must be supported by the manufacturers, contract testing entities, Proposed § 201.327(b) and testing required by proposed contract research organizations); and (3) § 201.327(h)(1) amend certain labeling § 201.327(i) and referenced in proposed clinical investigators conducting the requirements applicable to the PDP. § 352.70. As previously noted, certain testing (the investigator(s) required to Among other things, proposed SPF testing and labeling is already submit investigator statements and other § 201.327(b) sets forth labeling required under current regulations. This materials to the responsible person). requirements for the statement of analysis reflects the estimated FDA estimates that up to 772 entities identity and SPF value claims discussed additional burden of the proposed could meet the proposed definition of in this section. Proposed § 201.327(h)(1) changes to SPF testing and labeling responsible person (equivalent to applies to the statement of identity for requirements. ‘‘brands’’ in the economic analysis sunscreen products that also contain c. Burden for proposed statement of found in section XIII, Preliminary skin protectant active ingredients. identity and SPF value information Analysis of Economic Impacts). The Proposed § 352.50 requires that the PDP collections. The estimated burden for estimate of 772 entities also includes labeling comply with the requirements the statement of identity and SPF value nearly all entities to which a responsible of § 201.327(b). The SPF value information collections just described is person might transfer its obligations statements set forth in proposed provided in table 11 (Estimated Annual (‘‘transferees’’), such as contract § 201.327(b) and referenced in proposed Third-Party Disclosure Burden). For manufacturers, contract repackagers, § 352.50 are based on the results of the currently marketed OTC sunscreen contract distributors. For example, a testing required in proposed § 201.327(i) products, FDA believes that responsible manufacturer may be a responsible and proposed part 352 (§ 352.70). persons need only complete the testing person for one brand and a contract a. Statement of identity. Proposed (or reanalyze existing testing data) and manufacturer for another. However, in § 201.327(b)(1) requires that sunscreen relabel the product as required by the addition to the 772 entities and drug products bear a statement of rule one time, and may then continue to potential transferees already described, identity consisting of the name of each utilize the resultant labeling going we estimate that there are sunscreen active ingredient listed in forward without additional burden. We approximately 10 U.S.-based contract alphabetical order, followed by estimate that 772 respondents would testing entities used by multiple ‘‘Sunscreen’’ and ‘‘[Dosage form]’’ (e.g., need to complete this relabeling and responsible persons to conduct ‘‘Lotion’’, ‘‘Spray’’). Proposed related testing (if not already done) or sunscreen testing (e.g., contract § 352.52(a) requires the labeling to reanalysis of existing test results one laboratories and contract research contain a statement of identity in time for up to 4,078 total products. In organizations). These 10 potential accordance with § 201.327(b). addition, there may be new products transferees are not included in the 772 Proposed § 201.327(h)(1) applies to introduced each year. We estimate that figure. Thus, for certain information sunscreen drug products that also as many as 1,500 new OTC sunscreen collections, the estimated respondent contain skin protectant active product stock keeping units (SKUs) may number may be 782. We note that this ingredients; it requires that the product be introduced each year by up to 772 estimate does not include non-U.S.- bear a statement of identity consisting of respondents. These new products must based contract testing entities. the name of all sunscreen and skin be tested and labeled with the SPF value In addition to the 10 contract testing protectant active ingredients in and broad spectrum results determined entities, FDA estimates that alphabetical order, followed by in the tests. We estimate that the 1,500 approximately 10 of the estimated 772 ‘‘Sunscreen/Skin Protectant’’ and new sunscreen SKUs represent 975 new responsible persons conduct their own ‘‘[Dosage form],’’ presented in formulations.

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Table 11, row 1 provides FDA’s of the part 352 monograph), there is no reflected in the estimates regarding the estimate that 772 respondents will need additional burden. number of respondents below. to create PDP labeling for currently b. Investigator statements, CVs, and 2. Clinical Testing-Related Information marketed sunscreen formulations in related burden. Proposed Collection and Burden accordance with the statement of § 201.327(i)(1)(i) requires responsible identity and SPF value requirements of Proposed § 201.327(i) contains persons to, among other things, obtain a proposed § 201.327(b)(1), (b)(2), and requirements for clinical testing of SPF signed investigator statement from each (h)(1). This would be a one-time burden, values for inclusion on sunscreen investigator. Proposed and FDA estimates 5.2824 responses per product labeling. As previously noted, § 201.327(i)(1)(iv)(B) requires respondent for a total of 4,078 current regulations already require SPF responsible persons to obtain a signed responses. FDA estimates a burden of testing. While FDA expects that SPF investigator statement and CV. In FDA’s 0.5 hours per response. We estimate the testing and some of the proposed experience, investigators for SPF testing total burden of this recordkeeping to be recordkeeping is already being done, the are most often employed by the testing 2,039 hours. proposed changes are intended to clarify entities, and we therefore believe this is Table 11, row 2 provides FDA’s existing requirements applicable to a recordkeeping requirement rather than estimate that up to 772 respondents will sunscreen drug products and set forth a third-party reporting requirement. We need to create PDP labeling for new certain new requirements intended to request comment on this assumption. formulations each year in accordance improve the reliability of SPF testing As noted above, we estimate that with the statement of identity and SPF and ensure the protection of human responsible persons will typically value requirements of proposed subjects. Proposed § 352.70 references delegate this obligation to the § 201.327(b)(1), (b)(2), and (h)(1). FDA the § 201.327(i) testing requirements approximately 20 entities conducting estimates 1.943 responses per and makes the referenced testing final formulation testing. We estimate respondent for a total of 1,500 requirements part of the monograph that each testing entity employs one responses. FDA estimates a burden of conditions of use. clinical investigator to run the SPF 0.5 hours per response. We estimate the Across disciplines, testing involving testing they conduct. One investigator total burden of this recordkeeping to be human subjects is ordinarily conducted may run multiple SPF tests, and so long 750 hours. under IRB oversight as a means of as the responsible person (or testing Table 11, row 3 provides FDA’s ensuring that adequate human subject entity) has the investigator statement estimate that 20 respondents will protections are provided and to ensure and CV on file for each investigator, conduct SPF testing in accordance with the integrity of study design and there need not be a separate copy for § 201.327(i) (to determine the SPF value execution. Thus, in this proposed each investigation. required by § 201.327(b)(2)) for regulation, FDA is proposing to apply Table 10, row 1 provides FDA’s currently marketed sunscreen certain human subject protection estimate that approximately 20 formulations, if this has not already requirements to sunscreens, with the respondents will need to obtain and been done. This would be a one-time aim of having a framework similar to keep a signed investigator statement and burden. The estimated number of that used in the IND context, but CV in accordance with § 201.327(i)(1)(i) respondents reflects FDA’s assumption tailored to sunscreen testing. and (i)(1)(iv)(B). FDA estimates 2 based on its knowledge of the existing Information collections related to responses per respondent (1 CV and 1 market that, of the 772 responsible proposed § 201.327(i) are addressed in investigator statement) for a total of 40 persons, approximately 10 will conduct detail in the sections that follow. annual responses. FDA estimates a their own final formulation testing Regarding proposed § 352.70, as in the burden of 0.6 hours per response. We under § 201.327(i), while most will previous section, because the proposed estimate the total burden of this delegate the responsibility for change does not add any additional recordkeeping to be 24 hours. conducting final formulation testing to labeling or testing-related information c. Notifications and related burden. the approximately 10 independent collections not already addressed Proposed § 201.327(i)(1)(i) requires testing entities that FDA believes elsewhere (it cross-references the responsible persons to, among other conduct most final formulation testing. proposed § 201.327(i) testing things, ensure that FDA and all FDA estimates 111 responses per requirements as a condition of the part participating investigators are promptly respondent for a total of 2,220 352 monograph), there is no additional informed of significant new adverse responses. FDA estimates a burden of 24 burden. effects or risks with respect to the drug. hours per response. We estimate the a. Investigator statements and Proposed § 201.327(i)(1)(v) requires total burden to be 53,280 hours. notifications. Proposed § 201.327(i), responsible persons to keep each Table 11, row 4 provides FDA’s among other things, requires responsible participating investigator informed of estimate that 20 respondents will persons to obtain a signed investigator new observations about the drug, conduct SPF testing in accordance with statement and an investigator CV, and to particularly with respect to adverse § 201.327(i) (to determine the SPF value provide certain notifications (e.g., effects and safe use. As mentioned required by § 201.327(b)(2)) for new notification of adverse drug above, like other obligations associated sunscreen formulations. FDA estimates experiences). These may result in third- with testing under proposed 48.75 responses per respondent for a party disclosure or reporting § 201.327(i), we anticipate that this total of 975 responses. FDA estimates a requirements for responsible persons obligation will be delegated in most burden of 24 hours per response. We (and entities to which they have instances to the approximately 20 estimate the total burden to be 23,400 transferred relevant obligations) as well entities that currently conduct SPF hours. as for clinical investigators. As noted testing on behalf of responsible persons. Regarding proposed § 352.70, because above, our experience leads us to Table 9, row 1 provides FDA’s that section does not add any additional believe that most responsible persons estimate that approximately 20 labeling or testing-related information will transfer their obligations under respondents will need to inform FDA collections not already addressed § 201.327(i) to the approximately 20 and participating investigators of elsewhere (it incorporates the proposed entities that currently conduct clinical significant new adverse effects or risks SPF testing requirements as a condition SPF testing. This assumption is in accordance with § 201.327(i)(1)(i) and

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of new safety and other observations in responses. FDA estimates a burden of 3 publication of the final rule, FDA plans accordance with § 201.327(i)(1)(v). FDA hours per response. We estimate the to amend its approved information estimates up to 40 responses per total burden of this recordkeeping to be collection 0910–0139, if necessary, to respondent for a total of up to 800 2,925 hours. adjust the respective burden estimate(s) annual responses. FDA estimates a Proposed § 352.40(i)(1) references to account for any change. We request burden of 0.5 hours per response. We limitations on particle size for comment on the accuracy of our estimate the total burden of this sunscreens in a spray dosage form. assumptions and the resulting burden recordkeeping to be 400 hours. Proposed § 352.40(i)(2) and (3) proposes estimate. d. Informed consent, IRB review, and limitations on flammability and drying related burden. Proposed time for spray sunscreen formulations. B. Regulatory Status of Testing Entities § 201.327(i)(1)(ii) requires responsible These proposed sections (§ 352.40(i)(1) Proposed § 201.327(k) clarifies the persons to obtain informed consent, as through (3)) make the referenced regulatory status of final formulation defined in part 50, before clinical final limitations on flammability and particle testing, including that final formulation formulation testing and proposed size requirements part of the monograph testing conducted pursuant to § 201.327 § 201.327(i)(1)(iii) requires that clinical conditions of use. Proposed constitutes ‘‘manufacture’’ of a drug. As testing under § 201.327(i) be reviewed § 352.40(i)(5) states that applicable such, this testing must be conducted in and approved by an IRB meeting the requirements for particle size, an establishment registered in requirements of part 56. These two flammability, and drying time for spray accordance with part 207 and section proposed provisions make clear that sunscreens must be verified through 510 of the FD&C Act, and entities FDA’s regulations governing informed batch and lot testing as part of CGMP conducting final formulation testing consent (part 50) and IRB approval of compliance under part 211. Entities required by this section must comply research (part 56) apply to clinical final conducting testing required by these with CGMP and associated formulation testing conducted pursuant sections must also comply with recordkeeping requirements, including to § 201.327(i). associated recordkeeping requirements, those set forth in § 201.327(l) and in Regarding proposed § 201.327(i)(1)(ii) including those set forth in parts 210 parts 210 and 211. As this provision is and (iii), the information collections and 211. intended only to clarify an existing associated with FDA’s regulations The recordkeeping associated with requirement, it does not create a new governing informed consent (part 50) ensuring compliance with § 352.40(i)(5) information collection. and IRB approval of research (part 56) (batch and lot testing to ensure Entities covered by this provision are have previously been approved in compliance with particle size, already included in the burden accordance with the PRA under OMB flammability, and drying time estimates for the information collections control number 0910–0755. FDA does limitations) is considered to be part of associated with registration and listing not expect that proposed the manufacturers’ CGMP requirements requirements. Recordkeeping § 201.327(i)(1)(ii) or (iii) would affect under parts 210 and 211 (OMB control obligations related to registration and the number of recordkeepers, records, number 0910–0139). While FDA listing under part 207 and section 510 reports, or associated burdens included believes that sunscreen manufacturers of the FD&C Act are part of FDA’s in the existing approval (0910–0755), are already included among the approved information collection for part but we invite stakeholders to comment respondents counted for that collection, 207 (OMB control number 0910–0829). if they have a different view. and that many of those manufacturers CGMP recordkeeping obligations are Proposed § 201.327(i)(1)(vii) requires who have spray dosage products may part of FDA’s approved information investigators to provide safety reports already be conducting flammability and collection for part 211 (OMB control and a final study report to the drying time testing (e.g., many are number 0910–0139). responsible person. Although including flammability statements and C. Generating and Maintaining Records investigators are often employees of information about drying time in of SPF and Broad Spectrum Testing testing entities, we are basing our current product labeling), the proposed estimate on our assumption the inclusion of these requirements in the FDA is proposing specific respondents in this case are the sunscreen regulations is new. The recordkeeping requirements for SPF and investigators themselves because of the proposed rule specifies the particle size, broad spectrum testing to enable FDA to framing of the duty proposed by the flammability, and drying time better monitor responsible persons’ regulation. limitations that would be required for compliance with the requirements of Table 9, row 2 provides FDA’s sunscreens in spray dosage forms to be § 201.327. Recordkeeping is essential for estimate that up to 20 respondents will GRASE under the monograph. The FDA to evaluate whether required need to provide safety reports in proposed rule also specifies that testing of final formulations is being accordance with § 201.327(i)(1)(vii)(A). compliance with these limitations must conducted properly (both as to human FDA estimates 24.4 responses per be verified through batch and lot testing. subject protection and as to study respondent for a total of 488 annual While this greater specificity as to design) and to enable the Agency to responses. FDA estimates a burden of required testing might have a marginal investigate postmarketing product 0.5 hours per response. We estimate the effect on the burden associated with failures or adverse events. Appropriate total burden of this recordkeeping to be recordkeeping for manufacturing recordkeeping also enables FDA to 244 hours. facilities that are not already conducting conduct better and more efficient Table 9, row 3 provides FDA’s such testing, FDA believes that the total inspections of entities conducting final estimate that up to 20 respondents will change would be minimal in light of the formulation testing. The proposed need to provide a final report in total recordkeeping burden under parts recordkeeping requirements are in accordance with § 201.327(i)(1)(vii)(B). 210 and 211, which is estimated across alignment with the records required for This will occur one time per study, with thousands of manufacturers of a wide other types of manufacturing under each of the 20 investigators conducting variety of drugs. We request comment CGMPs as set forth in parts 210 and 211. multiple studies per year. FDA on these assumptions. If FDA Failure to maintain adequate records estimates 48.75 responses per determines that the assumptions are of testing equipment, methods, and respondent for a total of 975 annual incorrect, then, concurrent with observations can raise broad questions

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about the reliability of final formulation addresses maintenance records. The final formulation testing on behalf of testing. In FDA’s experience, there has proposed rule clarifies that, as multiple responsible persons, an error at been a lack of uniformity in testing manufacturing, final formulation testing one testing entity may affect data across entities’ approaches to recordkeeping must comply with CGMPs, and, multiple clinical SPF testing studies for for final formulation testing, raising accordingly, records documenting multiple different final formulations concerns about the Agency’s ability to proper maintenance of equipment used that are ultimately sold under different assess the reliability of the results of in final formulation testing must be labels. final formulation testing. The proposed generated and maintained by testing In particular, proposed § 201.327(l)(2) regulation would address these entities, consistent with existing requires that, in addition to any records concerns, clarify FDA’s expectations, obligations in part 211. required to be kept pursuant to parts and align the regulation with current Regarding proposed § 201.327(l)(1), 210 and 211, records of SPF testing best practices. the existing maintenance record must include: (1) Identification of the a. Potential transfer of obligations. obligations are part of FDA’s approved testing entity; (2) the product identifier Proposed § 201.327(a)(1) permits a information collection for part 211 and expected SPF; (3) characterization responsible person (defined in (OMB control number 0910–0139), and of the SPF standard sunscreen required § 201.327(a)) to transfer some or all of its FDA believes that most of the by proposed § 201.327(i)(3) (lot number, obligations to another entity (a respondents for this collection of manufacturing date, and results of high ‘‘transferee’’), except for obligations information (the approximately 20 performance liquid chromatography with respect to recordkeeping under entities we believe are conducting final (HPLC) SPF standard assay); (4) § 201.327(l). We note that this could formulation testing) are already documentation linking any blinded create some situations in which both the included among the recordkeepers samples with the product lot number responsible person and the transferee counted for that collection. The and formulation tested; (5) specific would be required to comply with proposed rule provides greater testing records for each human subject applicable recordkeeping requirements. specificity regarding what information (identification of the UV source used for The proposed provision would also should be included in maintenance testing and various specific test results require a written record of the transfer records maintained by facilities and the individual(s) who determined of obligations to be maintained by both conducting final formulation testing. the values); (6) the mean and standard parties to the transfer. While this greater specificity might have deviation from SPFi values, standard Regarding the record of an obligation a marginal effect on the burden error and determined SPF value derived transfer, FDA believes that it is usual associated with recordkeeping for these as set forth in proposed § 201.327(i)(7); and customary business practice for a facilities, and the number of (7) records for water resistance testing of written record of a transfer of respondents for this requirement may pool temperature, air temperature, and obligations to be maintained by both need to be increased by 10 (to reflect relative humidity as required by parties to the transfer. FDA does not contract testing entities that may not be proposed § 201.327(i)(8); and (8) records believe this requirement would incur currently registered as manufacturers), demonstrating compliance with any additional recordkeeping burden FDA believes that the total change proposed § 201.327(i)(1) requirements and believes it would meet the would be minimal in light of the total for adequate clinical testing procedures exception at 5 CFR 1320.3(b)(2). recordkeeping burden under parts 210 and conditions (e.g., individual case Regarding the potential for some and 211, which is estimated across histories and documentation of IRB recordkeeping obligations to fall on both thousands of manufacturers of a wide review). responsible persons and transferees, variety of drugs. We request comment Table 10, row 2 provides FDA’s although proposed § 201.327(a)(1) does on these assumptions. If FDA estimate that approximately 20 not itself impose a specific requirement determines that the assumptions are respondents will need to generate SPF to generate records, it does create the incorrect, then, concurrent with testing records in accordance with potential for some recordkeeping publication of the final rule, FDA plans proposed § 201.327(l)(2) for existing obligations to fall on both responsible to amend its approved information products that will be reformulated. FDA persons and transferees. In particular, if collection under OMB control number estimates 85.5 records per recordkeeper a responsible person has delegated all 0910–0139 as necessary to adjust the for a total of 1,710 records. This is a other responsibilities under § 201.327(i) respective burden estimate(s) in order to one-time burden. FDA estimates a and (j), they would nonetheless need to account for any change. burden of 24 hours per recordkeeping. maintain a copy of the records of final c. SPF testing records and related We estimate the total burden of this formulation testing required by burden. Proposed § 201.327(l)(2) recordkeeping to be 41,040 hours. § 201.327(l)(2) and (3). We have addresses SPF testing records and Table 10, row 3 provides FDA’s included the burden associated with requires that respondents keep records estimate that up to 20 respondents will keeping this copy in our assumption related to the identification of the entity need to generate SPF testing records in that there are 782 respondents for conducting the testing, the formulation accordance with proposed recordkeeping obligations as described being tested, equipment used, § 201.327(l)(2) for new formulations. below (20 entities that conduct testing, investigators, SPF standards, specific FDA estimates 48.75 records per 10 of whom are also responsible subject and test result data, and records recordkeeper for a total of 975 records. persons, plus 762 responsible persons demonstrating compliance with FDA estimates a burden of 24 hours per that delegate their responsibility for § 201.327(i)(1) governing the recordkeeping. We estimate the total conducting testing (e.g., to one of the 10 establishment of adequate clinical burden of this recordkeeping to be independent testing entities that are not testing procedures and conditions. This 23,400. themselves responsible persons)). We is important because failure of testing Table 10, row 4 provides FDA’s invite comment on whether our entities to keep adequate records to estimate that up to 782 respondents will estimates properly reflect the support final formulation testing may need to keep SPF testing records in recordkeeping obligations. leave FDA unable to verify the accordance with proposed b. Maintenance records and related reliability of the results of SPF testing. § 201.327(l)(2) for existing products that burden. Proposed § 201.327(l)(1) Because one testing entity may conduct will be reformulated. This is a one-time

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burden. FDA estimates 2.1867 records testing must include: (1) Identification Table 10, row 8 provides FDA’s per recordkeeper for a total of 1,710 of the testing entity; (2) records of estimate that up to 782 respondents will records. FDA estimates a burden of 0.33 sample information (product identifier need to keep broad spectrum testing hours per recordkeeping. We estimate and expected SPF, master key for records in accordance with proposed the total burden of this recordkeeping to blinded samples, sample number and § 201.327(l)(3) for existing products. be 564.3 hours. identifier code, polymethylmethacrylate This is a one-time burden. FDA Table 10, row 5 provides FDA’s (PMMA) plate surface topography estimates 5.215 records per estimate that up to 782 respondents will measurement, and sample holder recordkeeper for a total of 4,078 records. need to keep SPF testing records in orientation); (3) identification of each FDA estimates a burden of 0.17 hours accordance with proposed UV source used for sunscreen product per recordkeeping. We estimate the total § 201.327(l)(2) for new formulations. pre-irradiation; (4) records of sunscreen burden of this recordkeeping to be 693.3 FDA estimates 1.2468 records per product application (sample weights, hours. recordkeeper for a total of 975 records. equipment identification); (5) Table 10, row 9 provides FDA’s FDA estimates a burden of 0.33 hours measurements required by proposed estimate that up to 782 respondents will per recordkeeping. We estimate the total § 201.327(j)(4) to (6)); (6) records of need to keep broad spectrum testing burden of this recordkeeping to be critical wavelength and UVA1/UV ratio records in accordance with proposed 321.75 hours. values; (7) for each sample: The identity § 201.327(l)(3) for new formulations. With regard to the testing-related of the individual(s) conducting specific FDA estimates 1.2468 records per estimates, we note that the requirements testing steps; and (8) test dates for the recordkeeper for a total of 975 records. for obtaining certain medical history broad spectrum test conducted pursuant FDA estimates a burden of 0.17 hours information from test subjects are not to § 201.327(j), and sample report forms per recordkeeping. We estimate the total considered collections of information and supporting data. burden of this recordkeeping to be because information collected from Table 10, row 6 provides FDA’s 165.75 hours. subjects of clinical testing does not estimate that approximately 20 The recordkeeping burden is constitute information under 5 CFR respondents will need to generate broad estimated as described in the tables at 1320.3(h)(5), and that the referenced spectrum testing records in accordance the end of the PRA discussion. informed consent and IRB requirements with proposed § 201.327(l)(3) for With the exceptions noted above, we under parts 50 and 56 are covered by existing products. As with records of conclude that the other provisions of existing approvals, as previously SPF testing, this number of respondents this rule are not subject to OMB review discussed. reflects FDA’s assumption that most under the PRA. d. Broad spectrum testing records and responsible persons will delegate The proposed changes to part 310 do related burden. Proposed § 201.327(l)(3) responsibility for conducting testing not include any collections of addresses broad spectrum testing under § 201.327(j) to the approximately information subject to the PRA. records. The proposed rule requires 20 testing entities. FDA estimates 203.9 The remaining sections of part 347 do records related to the identification of records per recordkeeper for a total of not include any collections of the entity conducting the testing, the 4,078 records. This is a one-time information not already addressed in formulation being tested, equipment burden. FDA estimates a burden of 1.5 this analysis. used, investigators, UV standards, hours per recordkeeping. We estimate Section 201.327 and the remaining sunscreen application, and specific test the total burden of this recordkeeping to sections of part 352 either do not result data. This is important because be 6,117 hours. contain an information collection failure of testing entities to keep Table 10, row 7 provides FDA’s subject to PRA, or contain specific adequate records to support broad estimate that up to 20 respondents will labeling information, including spectrum testing may leave FDA unable need to generate broad spectrum testing directions and warnings, which are a to verify the reliability of testing results. records in accordance with proposed ‘‘public disclosure of information Failure at one testing entity may affect § 201.327(l)(3) for new formulations. originally supplied by the Federal data across multiple broad spectrum FDA estimates 48.75 records per Government to the recipient for the testing studies for multiple different recordkeeper for a total of 975 records. purpose of disclosure to the public’’ (5 final formulations that are ultimately FDA estimates a burden of 1.5 hours per CFR 1320.3(c)(2)) and, therefore, are not sold under different labels. recordkeeping. We estimate the total collections of information. In particular, proposed § 201.327(l)(3) burden of this recordkeeping to be FDA estimates the burden of this requires that records of broad spectrum 1,462.5 hours. information collection as follows:

TABLE 9—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Activity and 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response

Inform FDA and investigators of significant new ad- 20 40 800 0.5 (30 minutes) ..... 400 verse effects or risks (§ 201.327(i)(1)(i)) and new safety and other observations (§ 201.327(i)(1)(v)). Investigators provide safety reports in accordance 20 24.4 488 0.5 (30 minutes) ..... 244 with § 201.327(i)(1)(vii)(A). Investigators provide a final report in accordance with 20 48.75 975 3...... 2,925 § 201.327(i)(1)(vii)(B) (one time per study).

Total ...... 3,569 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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TABLE 10—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Activity and 21 CFR section Number of records per Total annual Average burden Total hours recordkeepers recordkeeper records per recordkeeping

Obtain and keep a signed investigator statement and 20 2 40 0.6 (36 minutes) ..... 24 CV in accordance with § 201.327(i)(1)(i) and (iv)(B). Generate SPF testing records for existing products 20 85.5 1,710 24...... 41,040 (§ 201.327(l)(2)) (one-time). Generate SPF testing records for new formulations 20 48.75 975 24...... 23,400 (§ 201.327(l)(2)). Keep SPF testing records for existing products 782 2.1867 1,710 0.33 (20 minutes) ... 564.3 (§ 201.327(l)(2)) (one-time). Keep SPF testing records for new formulations 782 1.2468 975 0.33...... 321.75 (§ 201.327(l)(2)). (20 minutes) ...... Generate Broad Spectrum testing records for existing 20 203.9 4,078 1.5...... 6,117 products (§ 201.327(l)(3)). Generate Broad Spectrum testing records for new 20 48.75 975 1.5...... 1,462.5 formulations (§ 201.327(l)(3). Keep Broad Spectrum testing records for existing 782 5.215 4,078 0.17 (10 minutes) .. 693.3 products (§ 201.327(l)(3)). Keep Broad Spectrum testing records for new formu- 782 1.2468 975 0.17 (10 minutes) .. 165.75 lations (§ 201.327(l)(3)).

Total ...... 773,788.6 1 There are no capital costs or operating or maintenance costs associated with this collection of information.

TABLE 11—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Number of disclosures Total annual Average burden Activity and 21 CFR section respondents per disclosures per disclosure Total hours respondent

Create PDP labeling in accordance with statement of 772 5.2824 4,078 0.5 (30 minutes) ..... 2,039 identity and SPF value requirements (§ 201.327(b)(1), (b)(2) and (h)(1)) for currently marketed sunscreen formulations (one-time bur- den). Create PDP labeling in accordance with statement of 772 1.943 1,500 0.5 (30 minutes) ..... 750 identity and SPF value requirements (§ 201.327(b)(1), (b)(2), and (h)(1)) for new formu- lations. Conduct SPF testing in accordance with § 201.327(i) 20 111 2,220 24...... 53,280 to determine SPF value for currently marketed sunscreen formulations (if not already done) (one- time burden). Conduct SPF testing in accordance with § 201.327(i) 20 48.75 975 24...... 23,400 to determine SPF value for new sunscreen formu- lations.

Total ...... 79,469 1 There are no capital costs or operating or maintenance costs associated with this collection of information.

In compliance with the PRA (44 the statute contains an express proposed rule, we are providing notice U.S.C. 3407(d)), the Agency has preemption provision or there is some and an opportunity for State and local submitted the information collection other clear evidence that the Congress officials to comment on this rulemaking. provisions of this proposed rule to OMB intended preemption of State law, or XVII. Consultation and Coordination for review. These requirements will not where the exercise of State authority With Indian Tribal Governments be effective until FDA obtains OMB conflicts with the exercise of Federal approval. FDA will publish a notice authority under the Federal statute.’’ We have analyzed this proposed rule concerning OMB approval of these The sole statutory provision giving in accordance with the principles set requirements in the Federal Register. preemptive effect to this proposed rule forth in Executive Order 13175. We is section 751 of the FD&C Act (21 have tentatively determined that the XVI. Federalism U.S.C. 379r). We have complied with all rule does not contain policies that We have analyzed this proposed rule of the applicable requirements under would have a substantial direct effect on in accordance with the principles set the Executive order and have one or more Indian Tribes, on the forth in Executive Order 13132. Section determined that the preemptive effect of relationship between the Federal 4(a) of the Executive order requires this proposed rule, if finalized, would Government and Indian Tribes, or on Agencies to ‘‘construe . . . a Federal be consistent with Executive Order the distribution of power and statute to preempt State law only where 13132. Through publication of this responsibilities between the Federal

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Authority: 21 U.S.C. 321, 331, 351, 352, transfer for the time period set forth in (i) SPF Broad Spectrum Statement. 353, 355, 358, 360, 360b, 360gg–360ss, 371, paragraph (l) of this section. For a product that has been shown to 374, 379e; 42 U.S.C. 216, 241, 262, 264. (ii) An entity that assumes any pass the broad spectrum test in ■ 2. Revise § 201.327 to read as follows: obligation(s) of a responsible person paragraph (j) of this section, the labeling must comply with the provisions of this states ‘‘Broad Spectrum SPF [insert the § 201.327 Over-the-counter sunscreen section applicable to the assumed labeled SPF value associated with the drug products; required labeling based on obligation and will be subject to the range into which the determined SPF effectiveness testing. same regulatory action as a responsible value falls, as set forth in the following The following provisions apply to an person for failure to comply with any table.]’’ over-the-counter (OTC) sunscreen drug obligation assumed under this section. product that is intended for application Thus, all references to ‘‘responsible TABLE 1 TO PARAGRAPH (b)(2)(i)— to the skin of humans for purposes of person’’ in this section apply to another SPF LABELING RANGES absorbing, reflecting, or scattering entity (e.g., a contract research radiation in the ultraviolet (UV) range at organization or testing laboratory) to the Range of Associated labeled wavelengths from 290 to 400 extent that it assumes one or more determined SPF values SPF value nanometers (nm), and that contains one obligations of a responsible person. or more of the following as an active (2) Personnel. A responsible person 60–80 ...... 60+. ingredient: Avobenzone, cinoxate, must select only investigators and other 50–59 ...... 50. dioxybenzone, ensulizole, homosalate, personnel qualified by appropriate 40–49 ...... 40. meradimate, octinoxate, octisalate, training and/or experience to conduct 30–39 ...... 30. octocrylene, oxybenzone, padimate O, final formulation testing pursuant to 25–29 ...... 25. sulisobenzone, titanium dioxide, or zinc this section. Personnel engaged in 20–24 ...... 20. oxide, alone or in combination. The testing under this section must have the 15–19 ...... 15. 2–14 ...... Determined SPF Value. provisions do not apply to OTC education, training, and experience, or sunscreen drug products marketed any combination thereof, to enable that under approved new drug applications person to adequately perform their (ii) SPF Statement. For a product that or abbreviated new drug applications. assigned functions. has not been shown to pass the broad The failure of a product covered by this (b) Principal display panel. The spectrum test in paragraph (j) of this section to comply with any provision of following labeling must be prominently section, the labeling states ‘‘SPF [insert this section, including the labeling of placed on the principal display panel: labeled SPF value associated with the such a product with any effectiveness (1) Statement of identity—(i) range into which the determined SPF claim based on testing that fails to Placement. The principal display panel value falls, as set forth in the table in comply with any provision of this of an over-the-counter sunscreen drug paragraph (b)(2)(i) of this section]’’. section, renders that product product bears a statement of identity as (iii) For a product with a determined misbranded under section 502 of the one of its principal features. Except as SPF value of at least 2 but less than 15. Federal Food, Drug, and Cosmetic Act. set forth in paragraph (h) of this section, The SPF statement is immediately (a) General obligations of responsible the statement of identity consists of the followed by an asterisk (‘‘*’’), and the persons. As used in this section, a name of each sunscreen active associated statement ‘‘*See Skin Cancer/ ‘‘responsible person’’ is the ingredient in the product as identified Skin Aging Alert’’ appears in the bottom manufacturer, packer, or distributor in this section, listed in alphabetical 30 percent of the principal display whose name appears on the labeling of order and followed by ‘‘Sunscreen’’ and panel. a product covered by this section. A ‘‘[Dosage form]’’ (e.g., ‘‘Lotion’’ (iv) Prominence of required responsible person must assure that ‘‘Spray’’). statements. The SPF Broad Spectrum final formulation testing conducted on (ii) Prominence. The statement of statement, SPF statement, and ‘‘*See its product(s) pursuant to paragraphs (i) identity must appear on the principal Skin Cancer/Skin Aging Alert’’ and (j) of this section complies with all display panel in boldface type at least statement, as applicable, must appear in applicable provisions of this section. one-quarter as large as the size of the boldface type at least one-quarter as (1) Transfer of obligations. (i) A most prominent printed matter on the large as the most prominent printed responsible person may transfer principal display panel, in lines matter on the principal display panel responsibility for any or all of its generally parallel to the base on which and in lines generally parallel to the obligations set forth in this section to the package rests as it is designed to be base on which the package rests as it is another entity (e.g., a contract research displayed and in direct conjunction designed to be displayed. The entire text organization and/or testing laboratory), with the most prominent display of the of the Broad Spectrum SPF or SPF except as set forth in paragraph (l) proprietary name or designation. The statement, as applicable, must appear in (recordkeeping) of this section. Any entire text of the statement of identity the same font style, size, and color with such transfer must be described in must appear in the same font style, size, the same background color and must writing. If not all obligations are and color with the same background appear as continuous text with no transferred, the writing is required to color, and as continuous text with no intervening text or graphic. The entire describe each of the obligations being intervening text or graphic, other than text of the ‘‘See Skin Cancer/Skin Aging assumed by the transferee. If all additional text provided in accordance Alert’’ statement, as applicable, must obligations are transferred, a general with paragraph (h) of this section. appear in the same font style, size, and statement that all obligations have been (2) Effectiveness claim. For purposes color with the same background color transferred is acceptable. Any obligation of this section, the term ‘‘determined and must appear as continuous text not covered by the written description SPF value’’ refers to the SPF value that with no intervening text or graphic. will be deemed not to have been equals the largest whole number less (3) Water resistance statements—(i) transferred. A written record of the than SPF¥(t*SE), determined for a For products that provide 40 minutes of transfer of obligations must be sunscreen product in accordance with water resistance according to the test in maintained by both parties to the paragraph (i) of this section. paragraph (i)(8)(i) of this section. The

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labeling states ‘‘Water Resistant (40 (1) For all sunscreen products. (i) The have a determined SPF value of 15 or minutes).’’ labeling states ‘‘Do not use [bullet] on higher. The labeling states ‘‘[bullet] Sun (ii) For products that provide 80 damaged or broken skin.’’ Protection Measures. [in bold font] minutes of water resistance according to (ii) The labeling states ‘‘When using Spending time in the sun increases your the test in paragraph (i)(8)(ii) of this this product [bullet] keep out of eyes. risk of skin cancer and early skin aging. section. The labeling states ‘‘Water Rinse with water to remove.’’ To decrease this risk, regularly use a Resistant (80 minutes).’’ (iii) The labeling states ‘‘Stop use and sunscreen with a Broad Spectrum SPF (iii) Prominence of water resistance ask a doctor if [bullet] rash occurs.’’ value of 15 or higher and other sun statement. For all products bearing a (2) For sunscreen products that are protection measures including: [bullet] water resistance statement, the broad spectrum with determined SPF limit time in the sun, especially from 10 statement must appear in boldface type values of at least 2 but less than 15 a.m.–2 p.m. [bullet] wear long-sleeved at least one-quarter as large as the most according to the SPF test in paragraph shirts, pants, hats, and sunglasses’’. prominent printed matter on the (i) of this section or that have not been (3) For products that satisfy the water principal display panel and in lines shown to pass the broad spectrum test resistance test in paragraph (i)(8) of this generally parallel to the base on which in paragraph (j) of this section. The first section. The labeling states ‘‘[bullet] the package rests as it is designed to be statement under the heading reapply: [bullet] after [select one of the displayed. The entire text of the water ‘‘Warnings’’ states ‘‘Skin Cancer/Skin following determined by water resistance statement must appear in the Aging Alert [in bold font]: Spending resistance test: ‘40 minutes of’ or ‘80 same font style, size, and color with the time in the sun increases your risk of minutes of’] swimming or sweating same background color, and as skin cancer and early skin aging. This [bullet] immediately after towel drying continuous text with no intervening text product has been shown only to help [bullet] at least every 2 hours’’. or graphic. prevent sunburn, not [in bold font] skin (4) For products that do not satisfy the (c) Indications. The labeling of the cancer or early skin aging.’’ water resistance test in paragraph (i)(8) product states, under the heading (3) For products in a spray dosage of this section. The labeling states ‘‘Uses,’’ the phrases listed in this form that meet the definition of either ‘‘[bullet] reapply at least every 2 hours paragraph, as appropriate. Other the term ‘‘flammable’’ or the term [bullet] use a water resistant sunscreen truthful and nonmisleading statements, ‘‘combustible’’ as defined in § 352.3(g) if swimming or sweating’’. describing only the uses that have been or (h) of this chapter, as applicable, (5) For sunscreen products in a spray established and listed in this paragraph, when tested in accordance with 16 CFR dosage form. The labeling states may also be used, as provided in 1500.43a—(i) Labeling statement. The ‘‘[bullet] Hold container 4 to 6 inches § 330.1(c)(2) of this chapter, subject to labeling states [bullet] ‘‘Flammable’’ or from the skin to apply. [bullet] Do not the provisions of section 502 of the ‘‘Combustible’’ (as applicable) followed spray directly into face. Spray on hands Federal Food, Drug, and Cosmetic Act by a colon and the statement ‘‘Keep then apply to face. [bullet] Do not apply relating to misbranding and the away from fire or flame.’’ in windy conditions. [bullet] Use in a prohibition in section 301(d) of the (ii) For products that have a drying well-ventilated area and avoid Federal Food, Drug, and Cosmetic Act time of less than 5 minutes. The labeling inhalation’’. against the introduction or delivery for states [bullet] ‘‘Wait 5 minutes after (f) Other information. The labeling of introduction into interstate commerce of application before approaching a source the product contains the following unapproved new drugs in violation of of heat or flame, or before smoking.’’ statement under the heading ‘‘Other section 505(a) of the Federal Food, Drug, (iii) For products that have a drying information:’’ ‘‘[bullet] protect the and Cosmetic Act. time of at least 5 minutes but less than product in this container from excessive (1) For all sunscreen products, the 10 minutes. The labeling states [bullet] heat and direct sun’’. following indication statement must be ‘‘Wait 10 minutes after application (g) False or misleading claims. There included under the heading ‘‘Uses’’: before approaching a source of heat or are claims that would be false and/or ‘‘[bullet] helps prevent sunburn’’. See flame, or before smoking.’’ misleading on sunscreen products. § 201.66(b)(4) for definition of bullet. (e) Directions. The labeling of the These claims include but are not limited (2) For sunscreen products that have product contains the following to the following: ‘‘Sunblock,’’ been shown to pass the broad spectrum statements, as appropriate, under the ‘‘sweatproof,’’ and ‘‘waterproof.’’ These test in paragraph (j) of this section and heading ‘‘Directions.’’ More detailed or similar claims will cause the product have a determined SPF value of 15 or directions applicable to a particular to be misbranded under section 502 of higher, the labeling may include the product formulation may also be the Federal Food, Drug, and Cosmetic following statement in addition to the included. Act. indication in paragraph (c)(1) of this (1) For all sunscreen products. (i) As (h) Labeling of products containing a section: ‘‘[bullet] if used as directed an option, the labeling may state ‘‘For combination of sunscreen and skin with other sun protection measures (see sunscreen use:’’. protectant active ingredients. Directions [in bold italic font]), (ii) The labeling states ‘‘[bullet] apply Statements of identity, indications, decreases the risk of skin cancer and [select one of the following: ‘liberally’ or warnings, and directions for use, early skin aging caused by the sun’’. ‘generously’] [and, as an option: ‘and respectively, applicable to each (3) Any labeling or promotional evenly’] 15 minutes before sun ingredient in the product may be materials that suggest or imply that the exposure’’. combined to eliminate duplicative use, alone, of any sunscreen reduces the (iii) As an option, the labeling may words or phrases so that the resulting risk of or prevents skin cancer or early state ‘‘[bullet] apply to all skin exposed information is clear and understandable. skin aging will cause the product to be to the sun’’. Labeling provisions in § 347.50(e) of this misbranded under section 502 of the (iv) The labeling states ‘‘[bullet] chapter do not apply to these products. Federal Food, Drug, and Cosmetic Act children under 6 months of age: Ask a (1) Statement of identity. The (21 U.S.C. 352). doctor’’. statement of identity of a sunscreen (d) Warnings. The labeling of the (2) For sunscreen products that have product that also contains one or more product contains the following warnings been shown to pass the broad spectrum skin protectant active ingredients, under the heading ‘‘Warnings’’. test in paragraph (j) of this section and identified in §§ 347.10(a), (d), (e), (g), h),

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(i), (k), (l), (m), and (r) of this chapter, engaged in SPF testing with the responsible person and the IRB, except consists of the names of all sunscreen information they need to conduct an when necessary to protect the safety, the and skin protectant active ingredients in investigation properly; must obtain a rights, or welfare of subjects; alphabetical order followed by signed investigator statement from each (ii) Will comply with all requirements ‘‘Sunscreen/Skin Protectant’’ and investigator; must ensure proper regarding the obligations of clinical ‘‘[Dosage form].’’ The statement of monitoring of the investigation(s); must investigators and all other pertinent identity must be prominently placed on ensure that the investigation(s) is requirements in this subpart; the principal display panel and conducted in accordance with written (iii) Will personally conduct or presented in accordance with paragraph general investigational plan(s) and supervise the described investigation(s); (b)(1)(ii) of this section. protocol(s); must ensure compliance (iv) Will inform any potential subjects (2) Indications. The labeling of the with paragraphs (i)(1)(ii) and (iii) of this that the drugs are being used for product states, under the heading section; and must ensure that FDA and investigational purposes and will ‘‘Uses,’’ any or all of the applicable all participating investigators are comply with the requirements relating indication(s) included in § 347.50(b) of promptly informed of significant new to obtaining informed consent (part 50 this chapter or in paragraph (c) of this adverse effects or risks with respect to of this chapter) and institutional review section. Other truthful and the drug. board review and approval (part 56 of nonmisleading statements, describing (ii) Informed consent. Effective this chapter); only the indications for use that have informed consent, as defined in part 50 (v) Will report to the responsible been established in § 347.50(b) of this of this chapter, must be obtained from person adverse experiences that occur chapter or listed in paragraph (c) of this all human subjects before initiating during the investigation(s); section, may also be used, as provided clinical final formulation testing under (vi) Will ensure that all personnel by § 330.1(c)(2) of this chapter, subject this paragraph (i). assisting in the conduct of the testing to the provisions of section 502 of the (iii) Institutional review board (IRB) are informed about their obligations in Federal Food, Drug, and Cosmetic Act approval. Clinical testing under this meeting the above commitments. relating to misbranding and the paragraph (i), must be reviewed and (2) Curriculum vitae. A curriculum prohibition in section 301(d) of the approved by an IRB meeting the vitae or other statement of qualifications Federal Food, Drug, and Cosmetic Act requirements of FDA’s regulations in of the investigator showing the against the introduction or delivery for part 56 of this chapter. education, training, and experience that introduction into interstate commerce of (iv) Control of personnel—(A) General qualifies the investigator to conduct the unapproved new drugs in violation of obligations. A responsible person is final formulation testing pursuant to section 505(a) of the Federal Food, Drug, responsible for ensuring that this paragraph (i). and Cosmetic Act. investigators and other personnel (v) Informing investigators. The (3) Warnings. The labeling of the conducting any testing under this responsible person must, as the overall product states, under the heading paragraph (i), conduct all investigations investigation proceeds, keep each ‘‘Warnings,’’ the applicable warnings for in accordance with the signed participating investigator informed of sunscreens in paragraph (d) of this investigator statement, the new observations discovered by or section and for skin protectants in investigational plan, and applicable reported to the responsible person on § 347.50(c) of this chapter. regulations. Responsible persons must the drug, particularly with respect to (4) Directions. The labeling of the ensure the implementation of adequate adverse effects and safe use. product states, under the heading safeguards to protect the rights, safety, (vi) Review of ongoing investigations. ‘‘Directions,’’ any or all of the applicable and welfare of subjects under he (A) The responsible person must directions for sunscreens, as set forth in investigator’s care. The responsible monitor the progress of all clinical paragraph (e) of this section, and for person must also ensure that testing being conducted on its final skin protectants, as set forth in investigators or other study personnel formulation pursuant to this paragraph §§ 347.50(d) and 347.60(d) of this will promptly report to the IRB all (i). chapter, unless otherwise stated in this changes in the clinical final formulation (B) A responsible person who paragraph. When the time intervals or testing and all unanticipated problems discovers noncompliance by an age limitations for administration of the involving risk to human subjects or investigator or other personnel with the individual ingredients differ, the others, and that investigators or other signed agreement, the general directions for the product may not personnel will not make any changes in investigational plan, or the requirements contain any dosage that exceeds those the clinical final formulation testing of this paragraph (i) or other applicable established for any individual without IRB approval, except where regulations (e.g., parts 50 and 56 of this ingredient in the applicable OTC drug necessary to eliminate apparent chapter) must promptly either secure monograph(s), and may not provide for immediate hazards to human subjects. compliance or end the investigator’s or use by any age group lower than the (B) Obtaining information from the other personnel’s participation in highest minimum age limit established investigator. Before permitting an testing conducted under this for any individual ingredient. When the investigator to begin participating in paragraph (i). directions for administration of the clinical final formulation testing under (C) The responsible person must sunscreen and skin protectant differ in this paragraph (i), the responsible review and evaluate the evidence any other way, the directions for person must obtain the following: relating to the safety and effectiveness of sunscreens in paragraph (e) of this (1) Investigator statement. A signed the final formulation as it is obtained section should be used. investigator statement containing the from the investigator. (i) Sun Protection Factor (SPF) name and address of the investigator (vii) Investigator reports—(A) Safety testing—(1) Adequate clinical testing and a commitment by the investigator reports. An investigator must procedures and conditions—(i) General that he or she— immediately report to the responsible obligations of responsible persons for (i) Will conduct the testing in person any serious adverse event, testing under this paragraph. accordance with the relevant, current whether or not considered related to the Responsible persons must provide protocol(s) and will only make changes final formulation, including those listed investigators and other personnel in a protocol after notifying the in the protocol, and must include an

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assessment of whether there is a I(l) = irradiance (Watts per square meter) at radiation intensity should be monitored reasonable possibility that the final each wavelength l with a broadband radiometer with a formulation being tested caused the t = exposure time (seconds) response weighted to match the Erythema-effective dose (E) is expressed as erythema action spectrum in ISO 17166 adverse event. The investigator must effective Joules per square meter (J/m2- record nonserious adverse events and eff). CIE S 007/E entitled ‘‘Erythemal report them to the responsible person reference action spectrum and standard according to the timetable specified in (C) The solar simulator radiation erythema dose,’’ which is incorporated the protocol. intensity must be determined using a by reference in paragraph (i)(2)(ii)(C) of (B) Final report. An investigator must handheld radiometer with a response this section. If a lamp must be replaced provide the responsible person with an weighted to match the spectrum in ISO due to failure or aging during a adequate report shortly after completion 17166 CIE S 007/E entitled ‘‘Erythemal phototest, broadband device readings of each investigation conducted by that reference action spectrum and standard consistent with those obtained for the investigator for the responsible person erythema dose,’’ dated 1999 (First original calibrated lamp will suffice edition, 1999–12–15; corrected and under this paragraph (i). until measurements can be performed reprinted 2000–11–15), which is (2) UV source (solar simulator)—(i) with the spectroradiometer at the incorporated by reference in accordance Emission spectrum. Filter a single port earliest possible opportunity. with 5 U.S.C. 552(a) and 1 CFR part 51. or multiport solar simulator so that it (3) SPF standard—(i) Preparation. You may obtain a copy from the ISO provides a continuous emission The SPF standard must be a formulation Copyright Office, Case Postale 56, CH– spectrum from 290 to 400 nanometers containing 7-percent padimate O and 1211, Geneva 20, Switzerland, (nm) with a limit of 1,500 watts per 3-percent oxybenzone. telephone +41–22–749–01–11 or fax square meter (W/m2) on total irradiance +41–22–74–09–47. https://www.iso.org. TABLE 3 TO PARAGRAPH (i)(3)(i)— for all wavelengths between 250 and You may inspect a copy at the Center for COMPOSITION OF THE PADIMATE O/ 1,400 nm. Drug Evaluation and Research, 10903 (A) The solar simulator must have the New Hampshire Ave., Bldg. 22, Silver OXYBENZONE SPF STANDARD following percentage of erythema- Spring, MD 20993, call 301–796–2090, effective radiation in each specified Percent by or at the National Archives and Records Ingredients weight range of wavelengths: Administration (NARA). For information on the availability of this Part A: TABLE 2 TO PARAGRAPH (I)(2)(I)(A)— material at NARA, call 202–741–6030, Lanolin ...... 4.50 SOLAR SIMULATOR EMISSION SPEC- or go to: https://www.archives.gov/ Cocoa butter ...... 2.00 TRUM federal-register/cfr/ibr-locations.html. Glyceryl monostearate .. 3.00 The solar simulator output should be Stearic acid ...... 2.00 Percent measured before and after each Padimate O ...... 7.00 Wavelength range Oxybenzone ...... 3.00 (nm) erythemal contribution 1 phototest or, at a minimum, at the Part B: beginning and end of each test day. This Purified water USP ...... 71.60 <290 ...... <0.1 radiometer should be calibrated using Sorbitol solution ...... 5.00 290–300 ...... 1.0–8.0 side-by-side comparison with the Triethanolamine, 99 per- 290–310 ...... 49.0–65.0 spectroradiometer (using the weighting cent ...... 1.00 290–320 ...... 85.0–90.0 factors determined according to Methylparaben ...... 0.30 290–330 ...... 91.5–95.5 paragraph (i)(2)(ii)(A) of this section) at Propylparaben ...... 0.10 290–340 ...... 94.0–97.0 the time of the annual Part C: 290–400 ...... 99.9–100.0 Benzyl alcohol ...... 0.50 spectroradiometric measurement of the Part D: 1 Calculation of erythema action spectrum solar simulator as described in Purified water USP ...... QS 1 described in paragraph (i)(2)(ii) of this section. paragraph (i)(2)(iv) of this section. 1 (B) In addition, UVA II (320–340 nm) (iii) Operation. A solar simulator must Quantity sufficient to make 100 grams. irradiance must equal or exceed 20 have no significant time-related (A) Step 1. Add the ingredients of Part percent of the total UV (290–400 nm) fluctuations (within 20 percent) in A into a suitable stainless steel kettle irradiance. UVA I (340–400 nm) radiation emissions after an appropriate equipped with a propeller agitator. Mix irradiance must equal or exceed 60 warm-up time and demonstrate good at 77 to 82 °C until uniform. percent of the total UV irradiance. beam uniformity (within 20 percent) in (B) Step 2. Add the water of Part B (ii) Erythema action spectrum. (A) the exposure plane. The delivered dose into a suitable stainless steel kettle Calculate the erythema action spectrum to the UV exposure site must be within equipped with a propeller agitator and ° weighting factor (Vi) at each 10 percent of the expected dose. begin mixing at 77 to 82 C. Add the wavelength l: (iv) Periodic measurement. To ensure remaining ingredients of Part B and mix that the solar simulator delivers the until uniform. (1) Vi (l) = 1.0 (250

Vi(l) = erythema action spectrum weighting mirrors, lenses, collimating devices, or Mix until uniform. Cool batch to 27 to factor at each wavelength l focusing devices). Daily solar simulator 32 °C.

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(ii) HPLC assay. Use the following verify the concentrations of padimate O (A) Instrumentation—(1) Equilibrate a high performance liquid and oxybenzone in the SPF standard: suitable liquid chromatograph to the chromatography (HPLC) procedure to following or equivalent conditions:

(i) Column ...... C–18, 250 millimeters (mm) length, 4.6 mm inner diameter (5 microns). (ii) Mobile Phase ...... 85:15:0.5 methanol: water: acetic acid. (iii) Flow Rate ...... 1.5 milliliters (mL) per minute. (iv) Temperature ...... Ambient. (v) Detector ...... UV spectrophotometer at 308 nano- meters. (vi) Attenuation ...... As needed.

(2) Use HPLC grade reagents for this section). The relative standard standard according to the following mobile phase. deviation in peak areas should not be steps: (B) Preparation of the HPLC reference more than 2 percent for either (i) Step 1. Weigh 1 g of the SPF standard. (1) Weigh 0.5 gram (g) of oxybenzone or padimate O. standard (described in paragraph (i)(3)(i) oxybenzone USP reference standard into (2) Calculate the resolution (R) of this section) into a 50-mL volumetric a 250-mL volumetric flask. Dissolve and between the oxybenzone and padimate flask. dilute to volume with isopropanol. Mix O peaks from one chromatogram as (ii) Step 2. Add approximately 30 mL well. follows: of isopropanol and heat with swirling (2) Weigh 0.5 g of padimate O USP until contents are evenly dispersed. reference standard into a 250-mL (iii) Step 3. Cool to room temperature volumetric flask. Dissolve and dilute to (15 to 30 °C) and dilute to volume with volume with isopropanol. Mix well. Where isopropanol. Mix well.

(3) Pipet 3 mL of the oxybenzone to = retention time for oxybenzone (iv) Step 4. Pipet 5.0 mL of the solution and 7 mL of the padimate O tp = retention time for padimate O preparation into a 50-mL volumetric solution into a 100-mL volumetric flask. Wo = oxybenzone peak width at baseline flask and dilute to volume with Dilute to volume with isopropanol and Wp = padimate O peak width at baseline isopropanol. Mix well. mix well. If the resolution (R) is less than 3, adjust the (2)(i) Inject 10-microliter of diluted (C) HPLC system suitability. (1) Make mobile phase or replace the column. SPF standard from paragraph three replicate 10-microliter injections (D) SPF standard assay. (1) The SPF (i)(3)(ii)(D)(1) of this section and of the HPLC reference standard standard is diluted to the same calculate the amount of oxybenzone and (described in paragraph (i)(3)(ii)(B) of concentration as the HPLC reference padimate O as follows:

(ii) The percent of oxybenzone and (5) Rarely burns; tans profusely (dark test subject has no preexisting skin padimate O in the SPF standard must be brown) (insensitive). pigmentation at the time of enrollment. between 95 and 105. (6) Never burns; deeply pigmented A suitable source of low power UVA, (4) Test subjects—(i) Number of (insensitive). such as a Woods lamp, is helpful in this subjects. A test panel should include (B) Skin type is based on first 30 to process. If any of these conditions are enough subjects to produce a minimum 45 minutes of sun exposure after a present, the subject is not qualified to of 10 valid test results. A maximum of winter season of no sun exposure. participate in the study. The presence of three subjects may be rejected from this Determine that each subject is not taking nevi, blemishes, or moles will be panel based on paragraph (i)(6)(v) of this topical or systemic medication that is acceptable if, in the physician’s section. known to alter responses to UV judgment, they will neither compromise (ii) Medical history. (A) Obtain a radiation. Determine that each subject the study nor jeopardize a subject’s medical history from each subject with has no history of sensitivities to topical safety. Subjects with dysplastic nevi emphasis on the effects of sunlight on products and/or abnormal responses to should not be enrolled. Excess hair on the subject’s skin. Determine that each sunlight, such as a phototoxic or the back is acceptable if the hair is subject is in good general health with photoallergic response. clipped. Shaving is unacceptable skin type I, II, or III as follows: (iii) Physical examination. Conduct a because it may remove a significant (1) Always burns easily; never tans physical examination to determine the portion of the stratum corneum and (sensitive). presence of sunburn, suntan, scars, temporarily alter the skin’s response to (2) Always burns easily; tans active dermal lesions, and uneven skin UV radiation. minimally (sensitive). tones on the areas of the back to be (3) Burns moderately; tans gradually tested. Adequate time must have passed (iv) Informed consent. Obtain legally (light brown) (normal). following any previous UV exposure effective written informed consent from (4) Burns minimally; always tans well (e.g., participation in a prior SPF all test subjects as required by paragraph (moderate brown) (normal). clinical study, tanning, etc.) so that the (i)(1)(ii) of this section.

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(5) Sunscreen application—(i) Test using an accurately calibrated solar doses administered; or the subject was site. Test sites are locations on each simulator. Select doses that are a noncompliant (e.g., the subject subject’s back, between the beltline and geometric series represented by 1.25n withdraws from the test due to illness the shoulder blades (scapulae) and (i.e., each dose is 25 percent greater than or work conflicts or does not shield the lateral to the midline, where skin the previous dose). exposed testing sites from further UV responses to UV radiation are (iii) UV exposure for final MEDu, radiation until the MED is determined). determined. Responses on unprotected ssMEDp, and tpMEDp. For each subject, (7) Determination of SPF. (i) Calculate skin (no test material applied) and determine the final MEDu, ssMEDp, and an SPF value for each test subject (SPFi) protected skin (sunscreen test product(s) tpMEDp by administering a series of five as follows: or SPF standard applied) are determined UV doses to the appropriate test sites. at separate unprotected and protected The middle dose (X) in each of these test sites, respectively. Test sites should dose series (i.e., the third dose) should be randomly located in a blinded equal the initial MEDu times the (ii) Calculate the mean manner. Each test site should be a expected SPF. Note that the expected minimum of 30 square centimeters and SPF equals 1 and 16.3 for the final outlined with indelible ink. MEDu and ssMEDp, respectively. The (ii) Test subsite. Test subsites are the remaining UV doses in the series and the standard deviation(s) from the locations to which UV radiation is depend upon the expected SPF value of SPFi values. Calculate the standard error administered within a test site. the sunscreen test product(s). For (SE), which equals s/√n (where n equals Administer UV doses to at least five test products with an expected SPF less than the number of subjects who provided subsites within each test site. Test 8, administer UV doses that increase by valid test results). Obtain the t value subsites must be at least 0.5 square 25 percent with each successive dose from Student’s t distribution table centimeters (cm2) in area and must be (i.e., 0.64X, 0.80X, 1.00X, 1.25X, and corresponding to the upper 5-percent separated from each other by at least 0.8 1.56X). For products with an expected point with n ¥ 1 degrees of freedom. cm. Each test subsite must be outlined SPF from 8 to 15, administer UV doses Determine the SPF value that is equal to with indelible ink. that increase by 20 percent with each the largest whole number less than (iii) Applying test materials. Apply successive dose (i.e., 0.69X, 0.83X, the sunscreen test product and the SPF 1.00X, 1.20X, and 1.44X). For products standard at 2 milligrams per square with an expected SPF higher than 15, In order for the SPF determination of a centimeter (mg/cm2) to their respective administer UV doses that increase by 15 test product to be considered valid, the test sites. Use a finger cot compatible percent with each successive dose (i.e., SPF value of the SPF standard must fall with the sunscreen to spread the 0.76X, 0.87X, 1.00X, 1.15X, and 1.32X). within the standard deviation range of product as evenly as possible. (iv) Evaluation of test subsites. In the expected SPF (i.e., 16.3 ± 3.43). (iv) Waiting period. Wait at least 15 order that the study personnel who (8) Determination of water resistance. minutes after applying a sunscreen evaluates the test subsites is not biased, To support labeling claims of water product before exposing the test sites to he/she should not be the same study resistance in accordance with paragraph UV radiation as described in paragraph personnel who applied the sunscreen (b) of this section, the following (i)(6) of this section. For water resistant product to the test site or administered procedure must be performed in an sunscreen products, proceed with the the UV doses. After UV doses are indoor fresh water pool, whirlpool, and/ water resistance testing procedure administered, record all immediate or hot tub maintained at 23 to 32 °C. described in paragraph (i)(8) of this responses. These may include an Fresh water is clean drinking water that section after waiting at least 15 minutes. immediate darkening or tanning, meets the standards in 40 CFR part 141. (6) UV exposure and erythema typically grayish or purplish in color, The pool and air temperature and the reading—(i) Definition of minimal which fades in 30 to 60 minutes; an relative humidity must be recorded. erythema dose (MED). The minimal immediate reddening at the subsite, due (i) Water resistance (40 minutes). erythema dose (MED) is the smallest UV to heating of the skin, which fades Determine the SPF value after 40 dose (quantity of erythema-effective rapidly; and an immediate generalized minutes of water immersion using the energy expressed as Joules per square heat response, spreading beyond the following procedure: meter) that produces perceptible subsite, which fades in 30 to 60 (A) Step 1: Apply the sunscreen test redness of the skin (erythema) with minutes. After the immediate responses product as described in paragraph (i)(5) clearly defined borders at 16 to 24 hours are noted, each subject should shield of this section. after UV exposure. The MED for the exposed area from further UV (B) Step 2: Perform moderate activity unprotected skin (MEDu) is determined radiation until the MED is determined. in water for 20 minutes. on a test site that does not have Determine the final MEDu, ssMEDp, and (C) Step 3: Rest out of water for 15 sunscreen applied. The MED for tpMEDp 16 to 24 hours after UV minutes. Do not towel test site(s). protected skin (MEDp) is determined on exposure. Evaluate the erythema (D) Step 4: Perform moderate activity a test site that has sunscreen applied. responses of each test subsite using in water for 20 minutes. An MEDp is determined for the SPF either tungsten or warm white (E) Step 5: Allow test sites to dry standard (ssMEDp). An MEDp is fluorescent lighting that provides at completely without toweling. determined for the sunscreen test least 450 lux of illumination at the test (F) Step 6: Apply the SPF standard as product (tpMEDp). site. For the evaluation, the test subject described in paragraph (i)(5) of this (ii) UV exposure for initial MEDu. For should be in the same position as when section. each test subject, no more than 1 day the test site was irradiated. (G) Step 7: Expose test sites to UV before testing a product, determine the (v) Invalid test data. Reject test data doses as described in paragraph (i)(6) of initial MEDu by administering a series of for a test subject if erythema is not this section. UV radiation doses expressed as J/m2-eff present on either the unprotected or (ii) Water resistance (80 minutes). (as determined according to paragraph protected test sites; or erythema is Determine the SPF value after 80 (i)(2)(ii)(B) of this section) to the test present at all subsites; or the responses minutes of water immersion using the subsites within an unprotected test site are inconsistent with the series of UV following procedure:

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(A) Step 1: Apply the sunscreen test (v) Dynamic range of the (5) Calculation of mean absorbance product as described in paragraph (i)(5) spectrometer. The dynamic range of the values. (i) Mean transmittance values, of this section. spectrometer should be sufficient to (B) Step 2: Perform moderate activity measure transmittance accurately in water for 20 minutes. through a highly absorbing sunscreen are converted into mean absorbance (C) Step 3: Rest out of water for 15 product at all terrestrial solar UV values, minutes. Do not towel test site(s). wavelengths (290 to 400 nm). (D) Step 4: Perform moderate activity (2) Sunscreen product application to in water for 20 minutes. PMMA plate. The accuracy of the test at each wavelength by taking the (E) Step 5: Rest out of water for 15 depends upon the application of a negative logarithm of the mean minutes. Do not towel test site(s). precisely controlled amount of transmittance value as follows: (F) Step 6: Perform moderate activity sunscreen product with a uniform in water for 20 minutes. distribution over the PMMA plate. The (G) Step 7: Rest out of water for 15 product is applied at 0.75 mg per square (ii) The calculation yields 111 minutes. Do not towel test site(s). centimeter to the roughened side of the monochromatic absorbance values in 1 (H) Step 8: Perform moderate activity PMMA plate. The sunscreen product nanometer increments from 290 to 400 in water for 20 minutes. should be applied in a series of small nanometers. (I) Step 9: Allow test sites to dry amounts over the entire PMMA plate (6) Number of plates. For each completely without toweling. and then spread evenly using a gloved sunscreen product, determine mean (J) Step 10: Apply the SPF standard as finger. Spreading should be done with absorbance values from at least three described in paragraph (i)(5) of this a very light spreading action for individual PMMA plates. Because section. approximately 30 seconds followed by paragraph (j)(4) of this section requires (K) Step 11: Expose test sites to UV spreading with greater pressure for at least 5 measurements per plate, there doses as described in paragraph (i)(6) of approximately 30 seconds. The plate must be a total of at least 15 this section. should then be allowed to equilibrate measurements. (j) Broad spectrum testing—(1) UV for 15 minutes in the dark before the (7) Calculation of the critical Spectrometry—(i) Plate. Use optical- pre-irradiation described in paragraph wavelength. The critical wavelength is grade polymethylmethacrylate (PMMA) (j)(3) of this section. identified as the wavelength at which plates suitable for UV transmittance (3) Sunscreen product pre-irradiation. the integral of the spectral absorbance measurements. The plate should be To account for lack of photostability, curve reaches 90 percent of the integral roughened on one side to a three- irradiate the PMMA plate with a solar over the UV spectrum from 290 to 400 dimensional surface topography simulator described paragraph (i)(2) of nm. The following equation defines the measure (Sa) between 2 and 7 this section. The irradiation dose must critical wavelength: micrometers and must have a be 4 MEDs which is equivalent to an rectangular application area of at least erythemal effective dose of 800 J/m2 16 square centimeters (with no side (i.e., 800 J/m2-eff). shorter than 4 cm). (4) Calculation of mean transmittance (ii) Sample holder. The sample holder values. (i) After pre-irradiation, Where should hold the PMMA plate in a determine the mean transmittance lc = critical wavelength horizontal position to avoid flowing of values for each wavelength l over the A(l) = mean absorbance at each wavelength the sunscreen product from one edge of full UV spectrum (290 to 400 dl = wavelength interval between the PMMA plate to the other. Mount the nanometers). Measure the transmittance measurements PMMA plate as close as possible to the values at 1 nanometer intervals. (8) Calculation of the UVA I/UV ratio. input optics of the spectrometer to Measurements of spectral irradiance The ratio of UVA I/UV is calculated as maximize capture of forward scattered transmitted for each wavelength l the area (per unit wavelength) under the radiation. The sample holder should be through control PMMA plates coated UVA I portions of a plot of wavelength a thin, flat plate with a suitable aperture with 15 microliters of glycerin (no versus A(l), divided by the area (per through which UV radiation can pass. sunscreen product) must be obtained unit wavelength) under the total curve, Place the PMMA plate on the upper from at least five different locations on as follows: surface of the sample holder with the the PMMA plate [C1(l), C2(l), C3(l), roughened side facing up. C4(l), and C5(l)]. In addition, a (iii) Light source. The light source minimum of five measurements of must produce a continuous spectral spectral irradiance transmitted for each distribution of UV radiation from 290 to wavelength l through the PMMA plate Where 400 nanometers. covered with the sunscreen product will A(l) = effective absorbance given as -log (iv) Input optics. Unless the be similarly obtained after pre- T(l)mean absorbance at each spectrometer is equipped with an wavelength, irradiation of the sunscreen product d(l) = wavelength interval between integrating sphere, an ultraviolet [P1(l), P2(l), P3(l), P4(l), and P5(l)]. measurements radiation diffuser should be placed (ii) The mean transmittance for each B(l) = any biological action spectrum factor between the sample and the input optics wavelength is the ratio of the mean of Because no appropriate biological action of the spectrometer. The diffuser will be the C(l) values to the mean of the P(l) spectrum for UVA radiation damage has constructed from any UV radiation values, as follows: been universally accepted, no action transparent material (e.g., Teflon or spectrum is specified. The value of B(l) quartz). The diffuser ensures that the is, therefore, equal to 1.0 for all radiation received by the spectrometer wavelengths. is not collimated. Set the spectrometer (9) Determination of broad spectrum input slits to provide a bandwidth that Where protection. A product that has both a is less than or equal to 5 nanometers. n ≥5 mean critical wavelength of 370 nm or

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greater, calculated in accordance with (A) Record of emission spectrum, total (vi) Records of the mean and standard paragraph (j)(7) of this section, and a irradiance, and percent of erythema- deviation from SPFi values, standard mean UVA I/UV ratio of 0.70 or greater, effective radiation contribution required error, and determined SPF value calculated in accordance with paragraph by paragraph (i)(2)(i) of this section; derived as set forth in paragraph (i)(7) (j)(8) of this section, is determined to (B) Record of each periodic of this section. pass the broad spectrum test. measurement required by paragraph (vii) Records for water resistance (k) Regulatory status of final (i)(2)(iv) of this section for each solar testing of pool temperature, air formulation testing and related simulator; temperature, and relative humidity as requirements. Final formulation testing (C) Record of each calibration, required by paragraph (i)(8) of this required under this section is realignment, or change in components section. considered a part of the manufacture of of each solar simulator, or any changes (viii) Records demonstrating a sunscreen product. Therefore, final to the broadband radiometer (or UV compliance with paragraph (i)(1) of this formulation testing required under this meter/dose control system), required by section governing the establishment of section must be performed in an paragraph (i)(2)(iv) of this section; and adequate clinical testing procedures and establishment registered in accordance (D) Record of each solar simulator conditions, including, but not limited with part 207 of this chapter and section output measurement required by to: 510 of the Federal Food, Drug, and paragraph (i)(2)(ii)(C) of this section. (A) Case histories. Responsible (2) SPF testing records. In addition to Cosmetic Act. Entities conducting final persons are required to prepare and any records required to be kept pursuant formulation testing required by this maintain adequate and accurate case to parts 210 and 211 of this chapter, section must also comply with current histories on each individual participant records of SPF testing performed good manufacturing practices (CGMPs) enrolled in SPF testing performed under and associated recordkeeping pursuant to paragraph (i) of this section must include: paragraph (i) of this section. Case requirements including those set forth histories must record all observations in paragraph (l) of this section and in (i) Identification of the entity that conducted the final formulation testing, and other data pertinent to the parts 210 and 211 of this chapter. investigation. Case histories include the Failure to comply with CGMPs or including the name and address of the establishment(s) at which testing was case report forms and supporting data recordkeeping requirements will mean (for example, signed and dated consent that any product labeled in reliance on carried out; (ii) The sunscreen test product forms, medical records including that testing will be adulterated. progress notes of the physician, the (l) Recordkeeping. Records required to identifier and characterization of the individual’s hospital chart(s), and the be kept under this section must be formulation being tested, including lot nurses’ notes (if applicable)). The case maintained for at least 1 year after the number, manufacture date, and history for each individual participant expiration date of all products labeled expected SPF; must document that informed consent in reliance on that testing or, in the case (iii) Characterization of the SPF was obtained pursuant to part 50 before of certain OTC drug products lacking standard sunscreen required by each individual’s participation in the expiration dating because they meet the paragraph (i)(3) of this section, criteria for exemption under § 211.137 including: study. Case histories as required by this of this chapter, 3 years after distribution (A) Lot number; section must include: (B) Manufacturing date; and of the last lot of drug product bearing (1) Protocol deviations or injuries, if (C) Results of HPLC SPF standard any; and labeling that relies on the testing. assay that verify compliance with the Recordkeeping requirements under this (2) Identification, by subject, of the concentrations of padimate O and study personnel who: Examined the section may not be transferred. oxybenzone in the SPF standard. Maintenance records required to be kept potential study site areas, who weighed (iv) Documentation linking any and applied the sunscreen, and who under (l)(1) must be kept by the testing blinded samples with the product entity. Records of final formulation provided the UV irradiation. identifier. (B) IRB review. Documentation that testing as described in paragraphs (l)(2) (v) For each human subject, records and (3) of this section must be kept by clinical research conducted pursuant to of: paragraph (i) of this section was the responsible person and any entity (A) The identification of the UV reviewed and approved by a registered that is performing final formulation source used for testing on that subject, IRB as required by paragraph (i)(1)(iii) of testing required by this section on including make, model, and serial this section. behalf of a responsible person pursuant number; to a transfer of obligations. (B) Initial and final individual MED (3) Broad spectrum testing records. Records of broad spectrum testing (1) Maintenance records. Entities for unprotected skin (MEDu), and the performing final formulation testing are identity of the study personnel who conducted pursuant to paragraph (j) of expected to maintain equipment in determined that value; this section must include: accordance with paragraph (k) of this (C) Final MED for sunscreen test (i) Identification of the entity that section and, as applicable, parts 210 and product protected skin (tpMEDp), and the conducted the final formulation testing, 211 of this chapter. Maintenance identity of the study personnel who including the name and address of the records must be kept for all equipment determined that value; establishment(s) at which testing was used for final formulation testing under (D) Final MED for SPF standard carried out; this section and must include: sunscreen protected skin (ssMEDp), and (ii) Records of sample information, (i) Documentation that equipment has the identity of the study personnel who including: been maintained in accordance with determined that value; and (A) A sunscreen test product established written specifications as (E) Individual SPFi values, including identifier and expected SPF. If the required by paragraph (k) of this section all valid test data and invalid test data samples used in testing under paragraph and parts 210 and 211 of this chapter; for the test product and for the SPF (j) of this section are blinded, then and standard sunscreen, and the identity of records must include a master key that (ii) Documentation of characterization the study personnel who determined enables samples to be re-identified. In of UV sources including: that value. all other cases, records must include a

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master key that links samples used to a access to and copy and verify any (3) Ethyl 4-[bis(hydroxypropyl)] sunscreen test product identifier. records and reports relating to final aminobenzoate (B) Sample number; formulation testing conducted under (4) Glyceryl aminobenzoate (C) Identifier code; this section. Upon written request by (5) Lawsone with dihydroxyacetone (D) Measurement of PMMA plate FDA, the responsible person must (6) Red petrolatum surface topography in micrometers; and submit the records or reports (or copies (7) Trolamine salicylate (E) Sample holder orientation (vertical of them) to FDA. The responsible person (8) Aminobenzoic acid or horizontal). must discontinue from further (9) Avobenzone (iii) Identification of each UV source participation in final formulation testing (10) Cinoxate used for sunscreen product pre- required by this section any investigator (11) Dioxybenzone irradiation, including make, model, and who has failed to maintain or make (12) Ensulizole serial number. available records or reports of the (13) Homosalate (iv) Records of sunscreen product investigation as required by this (14) Meradimate application, including: paragraph (l). (15) Octinoxate (A) A record of all sample weights, (16) Octisalate including analytical balance; and PART 310—NEW DRUGS (17) Octocrylene (B) For all equipment used; make, (18) Oxybenzone model, and serial number; ■ 3. The authority citation for part 310 (19) Padimate O (v) For each sample, all measurements continues to read as follows: (20) Sulisobenzone required by paragraphs (j)(4) to (6) of Authority: 21 U.S.C. 321, 331, 351, 352, (c) A sunscreen drug product that has this section. 353, 355, 360b–360f, 360j, 360hh–360ss, a determined sun protection factor (SPF) (vi) For each sample, records of 361(a), 371, 374, 375, 379e, 379k–l; 42 U.S.C. value, as defined in § 352.3(d) of this critical wavelength and the UVA I/UV 216, 241, 242(a), 262. chapter, of at least 15 when tested in ratio values required by paragraphs (j)(7) accordance with § 201.327(i) of this and (8) of this section. § 310.545 [Amended] chapter, but that has not been shown to (vii) For each sample: The identity of ■ 4. Amend § 310.545 by removing and pass the broad spectrum test in the study personnel who weighed and reserving paragraphs (a)(29) and § 201.327(j) of this chapter. applied the sunscreen to the PMMA (d)(31),and (40). (d) A sunscreen drug product that has plates; the identity of the study ■ 5. Add § 310.549 to subpart E to read a determined sun protection factor (SPF) personnel who provided the pre- as follows: value, as defined in § 352.3(d) of this irradiation; and the identity of the study chapter, of less than 2 or greater than 80 personnel, or, if calculated by software, § 310.549 Drug products offered over-the- counter (OTC) for use as sunscreen. when tested in accordance with what software, calculated the mean § 201.327(i) of this chapter. transmittance, mean absorbance values, (a) Any drug product offered OTC for (e) A sunscreen drug product that has critical wavelength, and UVA I/UV. use as sunscreen and identified in any a determined sun protection factor (SPF) (viii) For each sample, the test dates of paragraphs (b) through (i) of this value, as defined in § 352.3(d) of this for the broad spectrum test conducted section is not generally recognized as chapter, of less than 15 when tested in pursuant to paragraph (j) of this section, safe and effective and is regarded as a accordance with § 201.327(i) of this and sample report forms and supporting new drug within the meaning of section chapter and/or that does not pass the data including, for example, spectral 201(p) of the Federal Food, Drug, and broad spectrum test in § 201.327(j) of data, Excel files containing Cosmetic Act, for which an approved this chapter, and labeled with any of the transmittance or absorbance values, or new drug application under section 505 following or similar claims: any notes from the lab investigator. of the Federal Food, Drug, and Cosmetic (1) Decreases the risk of skin cancer (4) Food and Drug Administration Act and part 314 of this chapter is caused by the sun; or (FDA) inspection of records—(i) Testing required for marketing. In the absence of (2) Decreases the risk of early skin entity. Anentity performing final an approved new drug application, such aging caused by the sun. formulation testing under this section, product is also misbranded under (f) A sunscreen drug product labeled including a responsible person or an section 502 of the Federal Food, Drug, with any of the following or similar entity that has been transferred any and Cosmetic Act. Products offered OTC claims: obligations of a responsible person for use as sunscreen include those (1) Instant protection or protection under this section, must, upon request represented, labeled, or promoted as immediately upon application; or from any properly authorized officer or sunscreen, or for use to help prevent (2) Claims for ‘‘all-day’’ protection or employee of FDA, at reasonable times, sunburn, skin cancer, and/or skin aging extended wear claims citing a specific permit such officer or employee to have caused by the sun, or with similar number of hours of protection that is access to, and copy and verify any claims or representations. Clinical inconsistent with the directions for records or reports of testing pursuant to investigations designed to obtain application in § 201.327 of this chapter. this section. The testing entity is not evidence that any sunscreen drug (g) A sunscreen drug product that is required to divulge subject names product covered by this section is safe labeled, represented, or promoted for unless the records of particular and effective for the purpose intended use as a combined sunscreen-insect individuals require a more detailed must comply with the requirements and repellant. study of the cases, or unless there is procedures governing the use of (h) A sunscreen drug product that is reason to believe that the records do not investigational new drugs set forth in in any dosage form other than the represent actual case studies, or do not part 312 of this chapter. following: Oil, lotion, cream, gel, butter, represent actual results obtained. (b) A sunscreen drug product that paste, ointment, stick, or spray. (ii) Responsible persons. A contains any of the following (i) A sunscreen drug product in a responsible person must upon request ingredients: spray dosage form that has any of the from any properly authorized officer or (1) Diethanolamine following properties: employee of FDA, at reasonable times, methoxycinnamate (1) The product meets the definition permit such officer or employee to have (2) Digalloyl trioleate of the term ‘‘extremely flammable’’ as

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defined at § 352.3(f) of this chapter (2) Except as set forth in paragraph the largest whole number less than SPF when tested in accordance with 16 CFR (a)(3) of this section, for a combination ¥ (t * SE), determined for a sunscreen 1500.43a; drug product that does not have an product in accordance with § 201.327(i) (2) More than 10 percent of the established name, the labeling of the of this chapter. particles dispensed from the consumer product states the statement of identity (e) Labeled sun protection factor (SPF) container are smaller than 10 for each ingredient in the combination, value. The SPF value associated with micrometers; as established in the statement of the range into which the determined (3) Any of the particles dispensed identity sections of the applicable OTC SPF value falls, as set forth in the table from the consumer container are smaller drug monographs. in § 201.327(b)(2)(i) of this chapter. than 5 micrometers; or (3) For a product containing a (f) Extremely flammable. The term (4) The product meets the definition combination of skin protectant and ‘‘extremely flammable’’ applies to any of either the term ‘‘flammable’’ or the sunscreen active ingredients, the product that has a flashpoint at or below term ‘‘combustible’’ as defined at labeling of the product bears the 20 °F (¥6.7 °C) as determined by the §§ 352.3(g) or (h) of this chapter, as statement of identity set forth in test method described at 16 CFR applicable, when tested in accordance § 352.60(a) of this chapter. 1500.43a, except that any product with 16 CFR 1500.43a and has a (b) * * * having one component or more with a measured drying time of 10 minutes or (3) Combinations of skin protectant flashpoint higher than 20 °F (¥6.7 °C) more. and sunscreen active ingredients in that comprises at least 99 percent of the § 347.20(e). In addition to any or all of PART 347—SKIN PROTECTANT DRUG total volume of the product is not the indications for skin protectant drug PRODUCTS FOR OVER-THE- considered to be extremely flammable. products in § 347.50(b)(2)(i) of this COUNTER HUMAN USE (g) Flammable. The term ‘‘flammable’’ chapter, the required indications for applies to any product that has a ■ 6. The authority citation for part 347 sunscreen drug products in § 352.60(b) flashpoint above 20 °F (¥6.7 °C) and continues to read as follows: of this chapter must be used and any or below 100 °F (37.8 °C) as determined by Authority: 21 U.S.C. 321, 351, 352, 353, all of the additional indications for the test method described at 16 CFR 355, 360, 371. sunscreen drug products may be used. 1500.43a, except that: (c) * * * ■ (1) Any product having one 7. Amend § 347.20 by lifting the stay (1) For combinations containing a component or more with a flashpoint at on paragraph (e) (previously paragraph skin protectant and a sunscreen or above 100 °F (37.8 °C) that comprises (d), redesignated at 74 FR 9765, March identified in §§ 347.20(e) and 352.20(b). at least 99 percent of the total volume 6, 2009) and revising paragraph (e) to The warnings in § 352.60(c) of this of the product is not considered to be read as follows: chapter are used. flammable; and § 347.20 Permitted combinations of active * * * * * (2) Any product containing 24 percent ingredients. (d) * * * or less of water miscible alcohols, by * * * * * (1) For combinations containing a volume, in aqueous solution is not (e) Combinations of skin protectant skin protectant and a sunscreen considered to be flammable if the and sunscreen active ingredients. Any identified in §§ 347.20(e) and 352.20(b). product does not present a significant one (two when required to be in The directions in § 352.60(d) of this flammability hazard when used by combination) or more of the skin chapter are used. consumers. protectant active ingredients identified * * * * * (h) Combustible. The term in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), ‘‘combustible’’ applies to any product (m), and (r) of this chapter may be PART 352—SUNSCREEN DRUG having a flashpoint at or above 100 °F combined with any single sunscreen PRODUCTS FOR OVER-THE- (37.8 °C) to and including 150 °F (65.6 active ingredient identified in § 352.10 COUNTER HUMAN USE °C) as determined by the test method of this chapter, or any permitted ■ described at 16 CFR 1500.43a, except combination of these ingredients 9. The authority citation for part 352 that: identified in § 352.20 of this chapter, continues to read as follows: provided the product meets the Authority: 21 U.S.C. 321, 351, 352, 353, (1) Any product having one conditions in § 352.20(b) of this chapter 355, 360, 371. component or more with a flashpoint higher than 150 °F (65.6 °C) that and is labeled according to §§ 347.60 ■ 10. Lift the stay of 21 CFR part 352. and 352.60 of this chapter. comprises at least 99 percent of the total ■ 8. Amend § 347.60 by revising § 352.1 [Amended] volume of the product is not considered paragraphs (a), (b)(3), (c)(1), and (d)(1) to ■ 11. In paragraph (a), remove the words to be combustible; and read as follows: ‘‘in a form suitable for topical (2) Any product containing 24 percent administration’’. or less of water miscible alcohols, by § 347.60 Labeling of permitted ■ 12. Revise § 352.3 to read as follows: volume, in aqueous solution is not combinations of active ingredients. considered to be combustible if the * * * * * § 352.3 Definitions. product does not present a significant (a) Statement of identity. (1) Except as As used in this part: flammability hazard when used by set forth in paragraph (a)(3) of this (a) [Reserved] consumers. section, for a combination drug product (b) [Reserved] ■ 13. Add § 352.5 to subpart A to read that has an established name, the (c) Sunscreen active ingredient. An as follows: labeling of the product states the active ingredient listed in § 352.10 that established name of the combination absorbs, reflects, or scatters radiation in § 352.5 Sun protection factor related drug product, followed by the statement the ultraviolet (UV) range at conditions. of identity for each ingredient in the wavelengths from 290 to 400 (a) The product has a determined SPF combination, as established in the nanometers. value of at least 2 but no greater than 80. statement of identity sections of the (d) Determined sun protection factor (b) If the product has a determined applicable OTC drug monographs. (SPF) value. The SPF value that equals SPF value of at least 15, it also passes

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the broad spectrum test in § 201.327(j) (4) The product must be labeled when tested accordance with 16 CFR of this chapter. according to § 201.327(h) of this chapter 1500.43a, drying time for each lot of ■ 14. Revise § 352.10 to read as follows: and § 352.60. product must be conducted in (c) [Reserved] accordance with adequate written § 352.10 Sunscreen active ingredients. ■ 16. Add § 352.30 to subpart B to read specifications. The active ingredient of the product as follows: ■ 18. Revise § 352.50 to read as follows: consists of any of the following, under the conditions specified, including § 352.30 Route of administration. § 352.50 Principal display panel of all being within the concentration specified The product is intended for topical sunscreen drug products. for each ingredient: administration. The principal display panel labeling (a) through (o) [Reserved] ■ 17. Add § 352.40 to subpart B to read must comply with § 201.327(b) of this (p) Titanium dioxide up to 25 percent as follows: chapter. (q) [Reserved] ■ 19. Revise § 352.52 to read as follows: § 352.40 Dosage forms. (r) Zinc oxide up to 25 percent. § 352.52 Labeling of products containing ■ The product is in one of the following 15. Revise § 352.20 to read as follows: one or more sunscreen active ingredients. dosage forms and meets any additional § 352.20 Permitted combinations of active conditions specified: (a) Statement of identity. The labeling ingredients. (a) Oil. of the product contains the statement of The determined SPF of any product (b) Lotion. identity, in accordance with containing a sunscreen active ingredient (c) Cream. § 201.327(b) of this chapter. is measured by the testing procedures (d) Gel. (b) Indications. The labeling of the established in § 201.327(i) of this (e) Butter. product contains the indication chapter. (f) Paste. statements identified in § 201.327(c) of (a) Combinations of sunscreen active (g) Ointment. this chapter, as appropriate, and subject ingredients. Two or more sunscreen (h) Stick. to the conditions stated therein. active ingredients identified in § 352.10 (i) Spray, provided that all of the (c) Warnings. The labeling of the may be combined with each other in a following conditions are satisfied: product contains the warnings in single sunscreen product if all of the (1) Size of particles as dispensed from § 201.327(d) of this chapter, as following conditions are met: the consumer container: applicable, under the heading (1) Each sunscreen active ingredient (i) No more than 10 percent of the ‘‘Warnings:’’ in the product must satisfy the particles dispensed from the consumer (d) Directions. The labeling of the conditions established for its use in container are smaller than 10 product contains the statements in § 352.10. micrometers; and § 201.327(e) of this chapter, as (2) The concentration of each (ii) None of the particles dispensed applicable, under the heading sunscreen active ingredient must be from the consumer container are smaller ‘‘Directions.’’ sufficient to contribute a minimum than 5 micrometers. (e) Other information. The labeling of determined SPF of not less than 2 to the (2) The product does not meet the the product contains the statement in finished product. definition of the term ‘‘extremely § 201.327(f) of this chapter under the (3) The finished product must have a flammable’’ as defined in § 352.3(f). heading ‘‘Other information.’’ minimum determined SPF of not less (3) If the product meets the definition (f) False or misleading claims. The than the number of sunscreen active of either the term ‘‘flammable’’ or the labeling of the product must not contain ingredients used in the product term ‘‘combustible’’ as defined at any claims that would be false and/or multiplied by 2. §§ 352.3(g) or (h), as applicable, when misleading on sunscreen products, as outlined in § 201.327(g) of this chapter. (b) Combinations of sunscreen and tested in accordance with 16 CFR ■ skin protectant active ingredients. Any 1500.43a, the product also has a 20. Revise § 352.60 to read as follows: single sunscreen active ingredient measured drying time of less than 10 § 352.60 Labeling of products containing a identified in § 352.10 or any minutes. combination of sunscreen and skin combination of sunscreen active (4) The product is labeled as required protectant active ingredients. ingredients permitted under paragraph by §§ 201.327(d) and (e)(5) of this Statements of identity, indications, (a) of this section may be combined with chapter. warnings, and directions for use, one or more skin protectant active (5) Testing in accordance with part respectively, applicable to each ingredients identified in §§ 347.10(a), 211 of this chapter must confirm that ingredient in the product may be (d), (e), (g), (h), (i), (k), (l), (m), and (r) the product meets the conditions for combined to eliminate duplicative of this chapter when all of the following particle size, flammability, and drying words or phrases so that the resulting conditions are met: time as required by this section and information is clear and understandable. (1) Each sunscreen active ingredient reflected in the product labeling. Labeling provisions in § 347.50(e) of this in the product must satisfy the (i) Testing of each lot of product for chapter shall not apply to these conditions established for its use in size of particles dispensed from the products. § 352.10. consumer container must be conducted (a) Statement of identity. The labeling (2) The concentration of each in accordance with adequate written of the product bears the statement of sunscreen active ingredient must be specifications. identity, as set forth in § 201.327(h)(1) of sufficient to contribute a minimum (ii) Flammability testing for each this chapter. determined SPF of not less than 2 to the batch of product must be conducted in (b) Indications. The labeling of the finished product. accordance with the specifications set product states, under the heading (3) The finished product must have a forth in 16 CFR 1500.43a. ‘‘Uses,’’ the applicable indication minimum determined SPF of not less (iii) If the product meets the statements, as set forth in than the number of sunscreen active definition of either the term § 201.327(h)(2) of this chapter. ingredients used in the product ‘‘flammable’’ or ‘‘combustible’’ as (c) Warnings. The labeling of the multiplied by 2. defined at § 352(g) or (h), as applicable, product states, under the heading

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‘‘Warnings,’’ the applicable warning Subpart D—Final Formulation Testing § 352.80 Broad spectrum testing. statements, as set forth in Sec. If the product’s determined SPF value § 201.327(h)(3) of this chapter. 352.70 SPF testing. is at least 15, the product is tested and (d) Directions. The labeling of the 352.80 Broad spectrum testing. shown to pass the broad spectrum test product states, under the heading in § 201.327(j) of this chapter. Subpart D—Final Formulation Testing ‘‘Directions,’’ the applicable direction Dated: February 14, 2019. statements, as set forth in § 352.70 SPF testing. Scott Gottlieb, § 201.327(h)(4) of this chapter. Commissioner of Food and Drugs. The product is tested in accordance ■ [FR Doc. 2019–03019 Filed 2–21–19; 8:45 am] 21. Revise subpart D to read as with § 201.327(i) of this chapter. follows: BILLING CODE 4164–01–P

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Part III

Department of the Interior

Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Listing the Scarlet Macaw; Final Rule

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DEPARTMENT OF THE INTERIOR finding on a petition to list the scarlet prohibitions provided for endangered macaw. We determined the scarlet species under section 9 of the Act. For Fish and Wildlife Service macaw (A. m. macao) did not warrant threatened species, section 4(d) of the listing under the Act at the species level Act gives the Service discretion to 50 CFR Part 17 but found the northern subspecies of specify the prohibitions and any [Docket No. FWS–R9–ES–2012–0039; scarlet macaw (Ara macao cyanoptera) exceptions to those prohibitions that are 4500030113] and the northern distinct population appropriate for the species, as well as segment (DPS) of the southern include provisions that are necessary RIN 1018–BC81 subspecies (A. m. macao) warranted and advisable to provide for the listing and issued a proposed rule to list conservation of the species. A rule Endangered and Threatened Wildlife those entities as endangered under the issued under section 4(d) of the Act and Plants; Listing the Scarlet Macaw Act (77 FR 40222). On April 7, 2016, we allows us to include provisions that are AGENCY: Fish and Wildlife Service, published a revised proposed rule (81 tailored to the specific conservation Interior. FR 20302) maintaining the proposed needs of that threatened species. endangered status for A. m. cyanoptera, Our implementing regulations for ACTION: Final rule. but (1) revising the proposed listing threatened wildlife found at 50 CFR SUMMARY: We, the U.S. Fish and determination for the northern DPS of 17.31 incorporate the section 9 Wildlife Service (Service), determine the southern subspecies (A. m. macao) prohibitions for endangered wildlife, the northern subspecies of scarlet from endangered to threatened; and (2) except where a species-specific rule is macaw (Ara macao cyanoptera) is an proposing to treat the southern DPS of promulgated under 4(d) of the Act. endangered species under the A. m. macao and subspecies crosses as While we proposed to rescind this Endangered Species Act of 1973 (Act), threatened based on similarity of provision last summer (83 FR 35174; as amended; the northern distinct appearance to A. m. cyanoptera and the July 25, 2018), that proposal has not population segment (DPS) of the northern DPS of A. m. macao. We also been finalized at this time. Peer review and public comment. We southern subspecies of scarlet macaw proposed a rule under section 4(d) of sought comments from independent (A. m. macao) is a threatened species the Act (a ‘‘4(d) rule’’) that incorporated specialists to ensure that our under the Act, and the southern DPS of the prohibitions and provisions of 50 designation is based on scientifically the southern subspecies of scarlet CFR 17.31 and 17.32 that we found sound data, assumptions, and analyses. macaw (A. m. macao) and subspecies necessary and advisable for the species’ We invited peer reviewers and the crosses (A. m. cyanoptera and A. m. conservation. This rule lists the northern subspecies public to comment on our listing macao) to be threatened species based of scarlet macaw (A. m. cyanoptera) as proposals. All substantive information on similarity of appearance. We are also an endangered species, the northern from peer review and public comments establishing a rule pursuant to section DPS of the southern subspecies of was fully considered and is 4(d) of the Act for the A. m. macao scarlet macaw (A. m. macao) as a incorporated into this final rule, where subspecies and subspecies crosses to threatened species, and the southern appropriate. provide for its further conservation. DPS of the southern subspecies of Previous Federal Actions DATES: This rule is effective March 28, scarlet macaw (A. m. macao) and 2019. subspecies crosses (A. m. cyanoptera Please refer to the proposed listing ADDRESSES: Comments and materials we and A. m. macao) as a threatened rule, published in the Federal Register received, as well as supporting species due to similarity of appearance on July 6, 2012 (77 FR 40222), for more documentation used in preparation of under the Act. This rule also establishes comprehensive information on previous this rule, are available for public a 4(d) rule for those listed as threatened Federal actions for the scarlet macaw. inspection at http:// species to further provide for the The publication of the proposed listing www.regulations.gov. species’ conservation. rule opened a 60-day public comment The basis for our action. Under period, which closed on September 4, FOR FURTHER INFORMATION CONTACT: Don section 4(a)(1) of the Act, we determine 2012. Based on new information, we Morgan, Chief, Branch of Delisting and that a species is an endangered or published a revised proposed rule (81 Foreign Species, Ecological Services threatened species based on any of the FR 20302; April 7, 2016) to make the Program, U.S. Fish and Wildlife Service, following factors: (A) The present or following changes to our proposed rule: 5275 Leesburg Pike, MS:ES, Falls threatened destruction, modification, or (1) Revise the location of what we Church, VA 22041; telephone 703–358– curtailment of its habitat or range; (B) consider to be the boundary between the 2444. If you use a telecommunications overutilization for commercial, two subspecies of A. macao; (2) provide device for the deaf (TDD), you may call recreational, scientific, or educational additional information on the species in the Federal Relay Service at 800–877– purposes; (C) disease or predation; (D) northeast Costa Rica, southeast 8339. the inadequacy of existing regulatory Nicaragua, and Panama, and SUPPLEMENTARY INFORMATION: mechanisms; or (E) other natural or reevaluating the status of A. m. manmade factors affecting its continued cyanoptera; (3) provide additional Executive Summary existence. The primary causes attributed information on the northern DPS of Why we need to publish a rule. Under to the decline of the scarlet macaw A. m. macao, reevaluating the status of the Act, a species may warrant (A. m. cyanoptera and A. m. macao) this DPS, and revise our proposed protection through listing if it is include habitat loss and forest listing of this DPS from endangered endangered or threatened throughout all degradation (Factor A), poaching for the status to threatened status; (4) add a or a significant portion of its range. pet trade (Factor B), lack of enforcement proposal to treat the southern DPS of A. Listing a species as an endangered or of existing regulations (Factor D), and m. macao and subspecies crosses (A. m. threatened species can only be small population size (Factor E). macao and A. m. cyanoptera) as completed by issuing a rule. Section 4(d) of the Act authorizes the threatened based on similarity of On July 6, 2012, we published in the Secretary of the Interior (Secretary) to appearance to A. m. cyanoptera and to Federal Register (FR) a 12-month extend to threatened species the the northern DPS of A. m. macao; and

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(5) add a proposed rule pursuant to of the best scientific and commercial are not harmed by international trade section 4(d) of the Act (16 U.S.C. 1531 data available. Therefore, we may not and encourages wild bird conservation et seq.) to define the prohibitions and consider economic impacts when programs in countries of origin. Under exceptions that apply to scarlet macaws determining the status of a species. We the WBCA and our implementing listed as threatened. That revised understand that listing the scarlet regulations (50 CFR 15.11), it is proposed rule also opened a 60-day macaw will have an effect on those unlawful to import into the United public comment period, which closed involved in the pet bird industry, States any exotic bird species listed on June 6, 2016. especially bird breeders. The 4(d) rule under CITES except under certain that we are putting in place streamlines circumstances. The Service may issue Summary of Changes From the Revised the permitting process by extending permits to allow import of listed birds Proposed Rule certain prohibitions but deferring to for scientific research, zoological In this final rule, and based on public existing laws (CITES and the Wild Bird breeding or display, cooperative comments, we incorporate additional Conservation Act (WBCA) that are breeding, or personal pet purposes, information regarding the distribution of protective of scarlet macaws (A. m. when the applicant meets certain scarlet macaws in Mesoamerica (Mexico macao and subspecies crosses) in the criteria (50 CFR 15.22–15.25). Under the and Central America). Specifically, we course of import and export and by not Lacey Act, in part, it is unlawful: (1) To include information pertaining to requiring permits under the Act for import, export, transport, sell, receive, reintroduction programs occurring certain types of activities. Additionally, acquire, or purchase any fish, or wildlife throughout the range of Ara macao we are not prohibiting the interstate taken, possessed, transported, or sold in cyanoptera, and we include information commerce of scarlet macaws (A. m. violation of any law, treaty, or that indicates the populations in Costa macao and subspecies crosses) within regulation of the United States or in Rica in the northern DPS of the southern the United States (see 4(d) Rule, below). violation of any Indian tribal law; or (2) subspecies of scarlet macaw (A. m. Comment (2): Several commenters to import, export, transport, sell, macao) are likely increasing. stated that reducing the availability of receive, acquire, or purchase in We also took into account the relevant captive birds by listing the species interstate or foreign commerce any fish information from eBird into our analysis under the Act may lead to an increase or wildlife taken, possessed, regarding the distribution of the species. of wild-caught birds for the pet trade. transported, or sold in violation of any Our Response: We do not anticipate law or regulation of any State or in Summary of Comments and that listing the scarlet macaw under the violation of any foreign law. Similarly, Recommendations Act will further reduce the availability under the Lacey Act it is unlawful to We reviewed all comments we of captive birds or lead to an increase of import, export, transport, sell, receive, received from peer reviewers and the wild-caught birds for the pet trade. The acquire, or purchase specimens of this public for substantive issues and new scarlet macaw is listed in Appendix I of species traded contrary to CITES. information. All substantive information CITES, which is an international Based in large part on the protection from peer review and public comments agreement among governments to from illegal and legal trade afforded to has been fully considered and is ensure that the international trade of the scarlet macaw by CITES, the WBCA, incorporated into this final rule, where CITES-listed plants and animals does and the Lacey Act, the best available appropriate. not threaten the survival of the species data indicate that the current threat We received 282 public comments in the wild. Trade must be authorized from trade to the scarlet macaw stems combined on the proposed and revised through a system of permits and mainly from illegal trade in the proposed rules to list the scarlet macaw certificates that are issued by the domestic markets within Central and under the Act during their respective designated CITES Scientific and South America (Weston and Memon comment periods. Some of the Management Authorities of each CITES 2009, pp. 77–80; Shanee 2012, pp. 4–9). comments we received were similar to Party. For species included in CITES Additionally, interstate commerce comments that we received previously Appendix I, international trade is within the United States is not a current for the proposed rule; therefore, we only permitted only under exceptional threat to the scarlet macaw and will not address these comments once in this circumstances, which generally affect any efforts to recover wild final rule. See the Substantive Changes precludes commercial trade. The United populations. Therefore, we do not to the Proposed Rule section in the States implements CITES through the anticipate that listing the scarlet macaw revised proposed rule (81 FR 20302; Act and our implementing regulations at under the Act will further reduce the April 7, 2016). 50 CFR part 23. It is unlawful for any availability of captive-bred birds or lead The following section summarizes person subject to the jurisdiction of the to an increase of wild-caught birds since information and issues raised in the United States to engage in any trade in those birds are already regulated by public comments and provides our any specimens contrary to the existing laws. This 4(d) rule, in large responses. provisions of CITES, or to possess any part, adopts the framework of those Comment (1): Several commenters specimens traded contrary to the laws. stated that listing the scarlet macaw will provisions of CITES, the Act, or our Comment (3): Several commenters hurt U.S. businesses such as aviculture, implementing regulations at 50 CFR part stated that at least 25 States adopt the pet food and supply companies, and 23. Protections for CITES-listed species Federal Lists of Endangered and veterinarians. are provided independently of whether Threatened Wildlife and Plants to their Our Response: Determinations on a species is an endangered species or a State list, which they claim would make whether a species should be added to threatened species under the Act. it illegal to possess scarlet macaws or its the Federal Lists of Endangered and Two other laws in the United States feathers. The commenters stated that Threatened Wildlife and Plants are apart from the Act also already provide these laws do not include based on whether the species meets the protection from the illegal import of ‘‘grandfathering,’’ which means that definition of ‘‘endangered species’’ or of wild-caught birds into the United States: those who have scarlet macaws prior to ‘‘threatened species’’ in section 3 of the The WBCA and the Lacey Act (18 U.S.C. the listing and live in one of these States Act. The Act directs the Service to make 42–43; 16 U.S.C. 3371–3378). The would be in violation of the law these determinations solely on the basis WBCA ensures that exotic bird species immediately once the listing is effective.

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Our Response: Ownership of a listed Permits for prohibited activities, such as international trade in plants and species is not prohibited by the Act and interstate sale, import and export, can animals does not threaten their survival therefore, does not require a permit. We be issued for endangered species if the in the wild. Protection provided by further note that, under section 9(b)(1) activities enhance the propagation or other laws, such as CITES and WBCA, it is not unlawful to import or export a survival of the species in the wild. is taken into consideration when scarlet macaw that was held in captivity Additionally, a breeder could obtain a determining the status of the species. prior to the date of this final rule Captive-bred Wildlife Registration However, simply being protected by provided that its holding was not in the (CBW), which would authorize these other laws does not preclude the course of commercial activity. Further, interstate commerce. However, it must requirement to list and provide while we have certainly not conducted be shown that the sale enhances the additional protections under the Act an in-depth study on the various propagation or survival of the affected where the species meets the definition provisions of state law, we observe that species and the principal purpose is to of a threatened or endangered species. under Article I of the United States facilitate conservation breeding and not Further, the standards for listing under Constitution, retroactive application of a for the sale of protected species as pets. each legal regime are different, and the law is permitted only in extraordinary Comment (5): Several commenters protections afforded to species listed cases. Ex post facto laws (or laws that stated that the Endangered Species Act under each legal regime are different, criminalize conduct that was legal when is designed to protect domestic species though they can overlap in some originally performed) are generally only, and listing scarlet macaws under respects. While CITES regulates the prohibited. However, we acknowledge the Act does not address the main cause international trade of certain wildlife, it that we have no discretion over of decline for the species, which is has limited regulatory authority once regulations that certain States habitat destruction in the species’ native the species enters the United States for implement regarding federally listed countries. activities that take place within the wildlife and plants. Our Response: The broad definitions United States, though there are Comment (4): A few commenters of ‘‘species,’’ ‘‘fish or wildlife,’’ and restrictions on use after import for some stated that breeders and pet owners in ‘‘plant’’ in section 3 of the Act do not specimens, especially Appendix I the United States have been supplying differentiate between species native to specimens. Listing under the Act helps feathers through sales or trade to Native the United States, species native to both ensure that the United States and its American artisans, and the Service the United States and one or more other citizens do not contribute to the further should find a way to accommodate countries, and species not native to the decline of the species. feather and art sales within the United United States. Further, sections Conservation measures or benefits States because these artisans make 4(b)(1)(A) and 4(b)(1)(B)(i) expressly provided to foreign species listed as ceremonial products to support require the Service to consider efforts by endangered or threatened under the Act themselves and their tribes. a foreign nation prior to making a listing include recognition, requirements for Our Response: The 4(d) rule will determination. Additionally, the Federal protection, and prohibitions apply to all commercial and findings and purposes at sections against certain practices. Recognition noncommercial international shipments 2(a)(4), 2(a)(5), and 2(b) also speak to the through listing results in public of live and dead scarlet macaws, the application of the Act to meet the awareness, and may encourage and southern subspecies of A. m. macao and United States international result in conservation actions by foreign subspecific crosses (A. m. macao and commitments under treaties and governments, Federal and State A. m. cyanoptera), and their parts and conventions, and numerous provisions governments, private agencies and products, including the import and of the Act and the implementing interest groups, and individuals. export of personal pets and research regulations refer to foreign jurisdictions Comment (7): Several commenters samples. In most instances, the 4(d) rule (e.g., sections 8 and 8A of the Act, 50 noted that the International Union for adopts existing regulatory requirements CFR 424.11(e)). As such, we have no Conservation of Nature (IUCN) classifies of CITES and the WBCA as the basis to determine the protections of the the scarlet macaw as ‘‘least concern;’’ appropriate regulatory provisions for the Act only apply to domestic species. and therefore, listing under the Act is import and export of scarlet macaws. However, we acknowledge that we do not warranted. Under the 4(d) rule, a person may not have authority to directly regulate Our Response: The decision to list a deliver, receive, carry, transport, or ship activities in a foreign country that may species under the Act is based on A. m. macao and subspecies crosses in cause the species to be endangered or whether the species meets the definition interstate commerce in the course of a threatened. of an endangered or threatened species commercial activity, or sell or offer to Comment (6): Several commenters as defined under section 3 of the Act sell in interstate commerce without a stated that there is no benefit to listing and is made solely on the basis of the permit under the Act (see 4(d) rule, scarlet macaws under the Act because best scientific and commercial data below). Therefore, the 4(d) rule would the species is already sufficiently available. The IUCN uses different allow individuals to engage in certain protected by CITES and the WBCA. standards and criteria and the commercial activities with A. m. macao Our Response: The decision to list a designations are not interchangeable. and subspecies crosses that could species under the Act is based on Within certain countries, particularly in provide Tribal artisans materials to whether the species meets the definition the range of A. m. cyanoptera, the make their products. of an endangered or threatened species subspecies is considered in danger of The 4(d) rule does not include as defined under section 3 of the Act extinction or on a country’s list of subspecies A. m. cyanoptera that is and is made solely on the basis of the threatened or endangered species listed as endangered, and therefore, all best scientific and commercial data (Government of Mexico 2010a, p. 64; the prohibitions of 50 CFR 17.31 apply available. The purpose of the WBCA is (Biodiversity and Environmental to this subspecies. While the Act does to ensure that exotic bird species are not Resource Data System of Belize 2012, not prohibit intrastate (within a state) harmed by international trade and unpaginated; Meerman 2005, p. 30; sale of a listed species, it does prohibit encourages wild bird conservation (Government of Guatemala 2001, p. 15; interstate (between states) commercial programs in countries of origin. The Secretaria de Recursos Naturales y sale, unless a buyer obtains a permit. purpose of CITES is to ensure that Ambiente. 2008, p. 62). However,

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because of the relatively good status of are small and their total range bred for potential release into the wild the species in the Amazon, which represents only a portion of the range. and that are not in trade. We are not accounts for the majority of the species Northwest Colombia has large tracts of aware of any evidence indicating that range and population, and the scarlet suitable habitat capable of supporting a release of pet or pet-trade scarlet macaw’s relative tolerance of degraded population (although we have no macaws benefits wild populations. Pet and fragmented habitat (BLI 2011c, information about the current scarlet macaws are poor candidates for unpaginated), we found the scarlet population estimate for northwest reintroduction programs because those macaw did not warrant listing under the Colombia). However, because current bred for the pet trade are bred with little Act rangewide at the species level (A. m. threats to scarlet macaws are ongoing, regard for genetics and include an macao). The IUCN classified this enforcement of existing regulations is unknown number of subspecies crosses entity—the overall species—as ‘‘Least inadequate, and the population sizes of (Schmidt 2013, pp. 74–75), pets Concerned.’’ scarlet macaws in this region are small, socialized with humans fail to act Comment (8): A few commenters we reaffirm our determination that the appropriately with wild individuals questioned our decision in the revised northern DPS of A. m. macao is when released, and individuals held as proposed rule to change the northern threatened in accordance with the pets may pose a disease risk to wild DPS of the southern subspecies of definition in the Act. populations (Brightsmith et al. 2005, p. scarlet macaw (A. m. macao) from Comment (9): Several commenters 471). However, scarlet macaws bred in endangered to threatened. The stated that by listing the northern captivity for soft-release programs are commenters assert that because we subspecies of scarlet macaw (A. m. more appropriate than pet scarlet revised the boundaries and now cyanoptera) as endangered, bird owners macaws to contribute to the wild attribute the population on Isla Coiba, will not be able to sell birds, and if they population because of the breeding Panama, to be part of the northern cannot sell birds they will not breed techniques, decreased level of human subspecies (A. m. cyanoptera), the birds or will breed hybrids to get around interaction, disease testing, and training decline in the number of known the listing. Thus, the gene pool for A. m. of these birds to survive on their own populations for the northern DPS of cyanoptera will be reduced, if not be in the wild upon release. Refer to A. m. macao does not warrant a reversal eliminated. ‘‘Reintroduction of Scarlet Macaws,’’ of the Service’s prior determination. It Our Response: Commenters below, for examples of captive-bred indicates a reduction in the number of responding to the 2012 proposed rule birds raised and released into the wild populations; therefore, the DPS is now (77 FR 40222; July 6, 2012) noted that to integrate with the wild populations of at a greater risk of extinction. aviculturists have bred the species scarlet macaws. These birds released Our Response: The northern DPS of without regard for taxa, resulting in back into their native range and nearby the southern subspecies, A. m. macao, crosses of the two subspecies (A. m. existing populations may increase the consists of two main populations in cyanoptera and A. m. macao). overall population and contribute to the Costa Rica, the Central Pacific Costa Therefore, the best available information long-term conservation of the species. Rica (A´ rea de Conservacio´n Pacı´fico indicates that pet scarlet macaws may Comment (11): A few commenters Central (ACOPAC)) and South Pacific be bred with little regard for genetics stated that the information used in the Costa Rica (A´ rea de Conservacio´n Osa and include an unknown number of proposed rule was outdated. (ACOSA)) populations that are likely subspecies crosses, regardless of Our Response: The Service is required stable or increasing Vaughan et al. 2005, whether the species is listed under the by the Act to make determinations p. 128; Dear et al. 2010, p. 20; Act (Schmidt 2013, pp. 74–75). The Act solely on the basis of the best scientific Brightsmith 2016, in litt., pp. 10–13) does not prohibit intrastate (within a and commercial data available. We use and consist of 1,000 to 2,000 birds; a state) sale of a listed species so bird the existing information and are not group of at least 14–25 birds in Palo owners could sell birds within state, but required to develop new data. We based Verde (Brightsmith 2016, in litt., p. 14; because A. m. cyanoptera is listed as the proposed rule on all the information Dear et al. 2010, p. 8) in northwest Costa endangered, interstate (between states) we received following the initiation of Rica, along with scattered sightings of commercial sale is prohibited without a the status review for the scarlet macaw, scarlet macaws from Palo Verde permit. We do not believe that the gene as well as all of the information we National Park south to Carara National pool will be reduced or eliminated found during our own research and that Park and throughout western because while some scarlet macaws in received during the comment periods of Guanacaste (Brightsmith 2016, in litt., p. captivity in the United States will be a the 2012 proposed rule and 2016 14); small groups of captive-released mixture of subspecies, it is possible to revised proposed rule. The ‘‘best birds in some locations within the Costa determine with genetic techniques available’’ information depends on Rica portion of the DPS; small where individual scarlet macaws have research being conducted in the field populations in northwestern Panama in come from and whether or not they are and the availability of information and the Chiriquı´ province (Brightsmith from one pure single subspecies or a may be more, or less, recent depending 2016, in litt., p. 17; Sullivan et al. 2009, mix of subspecies (Brightsmith 2016, in on the efforts being conducted. After unpaginated), and an unknown number litt., p. 23). publishing the proposed rule, we found on the southern end of the Azuero Comment (10): Several commenters additional information that had become Peninsula of Veraguas, near Cerro Hoya stated that we dismiss the benefit of available since the publication of the National Park (Brightsmith 2016, in litt., captive-bred scarlet macaws, which may proposed rule and reviewed information p. 17; Sullivan et al. 2009, unpaginated; be used to repopulate the population if that was submitted by the public, Rodriguez and Hinojosa 2010, in a major natural, biological, or manmade including studies from a species expert McReynolds 2011, in litt., unpaginated); disaster occurs in the native habitat of and conservation organizations within and an unknown but likely small the species, and to educate and raise the scarlet macaw’s range countries. number of birds in northwest Colombia. awareness for the species. Comment (12): One commenter Thus, although the two largest Our Response: We find that there is a claimed that the Service violated populations currently appear to be difference in conservation value mandatory statutory deadlines by increasing and appear stable even with between captive-bred scarlet macaws waiting nearly 4 years to take further ongoing poaching pressure, they both that are bred for the pet trade and those action on its original listing proposal

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and never formally invoking the legally similarity of appearance and will international trade is permitted only allowable 6-month extension. therefore be treated at threatened. We under exceptional circumstances, which Our Response: We acknowledge that opened a new comment period to allow generally precludes commercial trade. we failed to meet the statutory deadline the public the opportunity to submit Any scarlet macaws or parts in for this rulemaking. However, we are additional comments in light of the new international trade to the United States obligated to make listing determinations information and our revised would require documentation that under the Act based on the best determinations. Thus, we have used this indicates the source and purpose of the available scientific and commercial time to consider and incorporate specimen or parts, and we identify information. In our proposed rule (77 complex data so that we may ensure our which countries the southern FR 40222; July 6, 2012), we found that rulemaking is based on the best subspecies (A. m. macao) and potential the northern subspecies of scarlet available information. subspecies crosses (A. m. macao and macaw, A. m. cyanoptera, and the Comment (13): A few commenters A. m. cyanoptera) are located in the northern DPS of the southern claimed that the Service offers no wild. Birds from the two extremes of the subspecies, A.m. macao, were in danger explanation on how the proposed 4(d) range (Mexico and the Amazon) are of extinction (an endangered species) rule allowing all commercial and morphologically discernable (Schmidt based on their populations sizes and the noncommercial international shipments 2011, pers. comm.). However, we magnitude of threats, such as loss of of live or dead members of the southern recognize that it can be difficult to habitat and poaching, within the subspecies (A. m. macao) and differentiate between subspecies and subspecies crosses (A. m. macao and determine whether the specimen is part subspecies’ respective ranges. We also A. m. cyanoptera) can be effectively of A. m. cyanoptera, and also requires found the southern DPS of the southern limited to only those entities given the a permit under the Act. Over the last 20 subspecies, A. m. macao, not to be similarity of appearance. The proposed years less than 200 entries in the LEMIS warranted for listing under the Act. 4(d) rule depends entirely on the ability (Law Enforcement Management During the public comment period on to differentiate between birds and Information System) database were the proposed rule, we received several products made from their bodies, which scarlet macaw parts or unspecified, and requests from the public to extend the the Service has previously stated cannot 38 percent of the overall entries were comment period. Additionally, be done without genetic analysis. seized. Therefore, even if some parts are subsequent to the proposed rule, we Our Response: Scarlet macaw difficult to determine which subspecies received new information from the subspecies, A. m. macao and A. m. of scarlet macaw without genetic public and peer review, and we issued cyanoptera, primarily differ in the analysis, which would add considerable a revised proposed rule (81 FR 20302; coloration of their wing coverts (a type cost and effort to law enforcement, the April 7, 2016). As a result of this of feather) and wing size. We recognize quantity of scarlet macaw imports into information, we made five substantive that differences between A. m. the United States is not extensive. changes to our July 6, 2012, proposed cyanoptera and A. m. macao are not Comment (14): One commenter cited rule. Specifically, we: (1) Revised the always apparent, particularly in birds Matuzak et al. (2008) for evidence that location of what we consider to be the from the middle of the species’ range, scarlet macaws are willing to feed on boundary between the northern and evidence in trade is usually in the introduced species, which makes the subspecies, A. m. cyanoptera, and the form of partial remains, detached species less susceptible to loss of native northern DPS of the southern feathers, and artwork incorporating their habitat. The commenter asserts that this subspecies, A. m. macao; (2) provided feathers. Additionally, aviculturists is one reason why we should not list additional information on A. m. often breed species without regard to A. m. cyanoptera as endangered. cyanoptera in northeast Costa Rica, their taxa. Thus, identification of the Our Response: The fact that scarlet southeast Nicaragua, and Panama, and subspecies or the geographic origin of macaws consume nonnative species reevaluated the status of the subspecies; birds can be difficult or improbable does not change our determination that (3) provided additional information on without genetic analysis. A. m. cyanoptera is in danger of the northern DPS of A. m. macao, The 4(d) rule allows a person to extinction because of the extent of the reevaluated the status of this DPS, and import or export certain scarlet macaws decline in the range and numbers of Ara revised our proposed listing of this DPS (A. m. macao and subspecies crosses macao cyanoptera due to ongoing from endangered status to threatened (A. m. macao and A. m. cyanoptera)) habitat destruction and degradation, status; (4) added a proposal to treat the without a permit issued under the Act. poaching for the pet trade, the lack of southern DPS of A. m. macao and However, to import and export scarlet enforcement of existing regulatory subspecies crosses (A. m. cyanoptera macaws a person must follow mechanisms addressing these threats, and A. m. macao) as threatened based procedures and requirements of CITES and the small population sizes that on similarity of appearance to A. m. and the WBCA, as the 4(d) rule adopts work in combination with the other cyanoptera and to the northern DPS of existing conservation regulatory threats. A. m. macao; and (5) added a proposed requirements of CITES as the Comment (15): A few commenters rule under section 4(d) of the Act to appropriate regulatory provisions for the stated that threats to A. m. cyanoptera define activities that are necessary and import and export of certain scarlet have been reduced over the past decade advisable for the conservation of scarlet macaws (see 4(d) Rule, below). Both due to ongoing conservation efforts. The macaws listed as threatened and crosses subspecies of the scarlet macaw are commenters also assert that our of the two scarlet macaw subspecies. We listed in Appendix I of CITES, which description of ‘‘extreme fragmentation then revised our determination for the ensures that the international trade of of habitat and population’’ is an southern subspecies of A. m. macao in CITES-listed species does not threaten overstatement and habitat loss and consideration of the new information the survival of the species in the wild. fragmentation do not threaten the and comments we received to conclude Trade must be authorized through a survival of A. m. cyanoptera. They that the northern DPS of A. m. macao’s system of permits and certificates that claim scarlet macaws can fly dozens to risk of extinction is not as imminent as are issued by the designated CITES hundreds of kilometers in a day and previously determined and that the Authorities of each CITES country. For generally overcome fragmentation of southern DPS of A. m. macao has species included in CITES Appendix I, populations; scarlet macaws use small

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protected areas with sufficient large Our Response: We are not aware of scarlet macaws presently exist there, trees; and large areas of undisturbed any information indicating that disease and is undercut by the finding that habitat exist in Northern Central poses a significant threat to the species, deforestation is ongoing and expected to America. Thus, A. m. cyanoptera should especially in northern Central America. continue in this area. not be listed as endangered. The risk of introducing diseases into Our Response: The scarlet macaw was Our Response: Reintroduction wild populations increases when a large reported to occur in relatively small programs to introduce captive-bred number of birds are introduced areas outside the Amazon, including scarlet macaws into wild populations annually, but this is cost-prohibitive west of the Andes in northwest have proven successful, especially and unlikely (Boyd and McNab 2008, p. Colombia (Hilty and Brown 1986, p. within the range of A. m. cyanoptera vii). Generally speaking, disease risk is 200). The best available information (see ‘‘Reintroduction of Scarlet small because the probable frequency of indicates that the population in Macaws,’’ below). Information provided occurrence is low (Clum 2008, p. 79). As northwest Colombia faces significant by a peer reviewer of the revised long as adequate disease testing is ongoing threats and may be potentially proposed rule (81 FR 20302; April 7, performed, and there are existing extirpated from this region (Donegan 2016) indicates that the scarlet macaw is protocols for minimizing the threat of 2013, in litt.; Ellery 2013, in litt.; likely increasing in numbers in the introducing exogenous diseases (i.e., McMullen 2010, p. 60). However, border region on the Caribbean slope of diseases that originate outside of the although no current population southeastern Nicaragua and organism) into wild populations, the estimates are available, this region is northeastern Costa Rica, as well as birds for release could come from reported to have large tracts of forest showing an ability to inhabit human- multiple suitable sources (Boyd and suitable for supporting scarlet macaws disturbed habitats. However, McNab 2008, p. vii, Boyd et al. 2008, p. (Ortega and Lagos 2011, p. 82; Salaman destruction of forest habitat is one of the 112). et al. 2009, p. 21). While the commenter main causes of the decline of the scarlet Comment (17): Some commenters did not provide any additional macaw in Mesoamerica (Comisio´n disagreed with proposing a 4(d) rule information to their concern, the Nacional Para el Conocimiento y Uso de that would allow the import and export information that this region is reported la Biodiversidad (CONABIO) 2011, p. 5; of captive-bred scarlet macaws and to have large tracts of suitable habitat Lezama 2011, pers. comm.; McGinley et interstate commerce without a permit. was not a focus of our status al. 2009, p. 11; Garcia et al. 2008, p. 50; Our Response: The Act does not determination regarding the status of the Hansen and Florez 2008, pp. 48–50; prohibit these activities for threatened population of A. m. macao. Snyder et al. 2000, p. 150; Collar 1997, species. However, under 4(d), we may Comment (19): A few commenters p. 421; Forshaw 1989, p. 406; Ridgely extend some or all of the prohibitions of provided new information concerning 1981, pp. 251–253). The remaining 9(a)(1) to threatened species and are reintroduction efforts in the native range forest is fragmented and includes few exercising our authority to do so here. of A. m. cyanoptera and the northern large tracts of forest habitat (Bray 2010, We assessed the conservation needs of DPS of A. m. macao. These commenters pp. 92–93; Snyder et al. 2000, p. 150; the scarlet macaw in light of the broad encouraged us to incorporate Wiedenfeld 1994, p. 101). Although protections provided to the species information about reintroduction deforestation rates have declined in under CITES and the WBCA. The best programs into our final rule. The Mesoamerica since 1990, they are still available data indicate that the current commenters claimed that positive very high (FAO 2010a, pp. 232–233; threat of trade to the scarlet macaw information, such as captive-breeding Kaimowitz 2008, p. 487). Deforestation stems mainly from illegal trade in the and release programs that are occurring is occurring in many areas within the domestic markets of Central and South throughout the species’ range, are range of A. m. cyanoptera, including, America (Weston and Memon 2009, pp. discounted compared to negative but not limited to, in Chiapas, Mexico, 77–80; Shanee 2012, pp. 4–9). information, such as threats, on western Pete´n in Guatemala; in the Accordingly, we find that adopting the population status. They encouraged the Mosquitia region in eastern Honduras import and export prohibitions of Service to equally consider information and Nicaragua; and southeastern 9(a)(1), which extend only to the for and against endangerment, including Nicaragua (Kaimowitz 2008, p. 487; jurisdiction of the United States, would the potential uses of captive birds in Fagan et al. 2013, unpaginated; Chassot not regulate such activity and is not conservation. and Monge-Arias 2012, p. 63; Chassot likely to impact the species status. Our Response: Captive-bred birds and Monge-Arias 2011, p. 1; Chassot et Additionally, because interstate released back into their native ranges al. 2009, p. 9). Therefore, as discussed commerce within the United States has and nearby existing populations have in our July 6, 2012, and April 7, 2016, not been found to threaten the scarlet the potential to increase the overall proposed rules, and reaffirmed herein, macaw or affect efforts at recovery of population in the wild and contribute to the low numbers of individuals of this wild populations, and international the long-term conservation of the subspecies, fragmentation of its habitat trade of this species is regulated under species, although the success of and population, and the substantial CITES, we do not find it necessary to reintroduced scarlet macaws partly threats of habitat loss and poaching regulate such activity for this species. depends on the methods used to raise acting on this subspecies throughout its Therefore, we find the 4(d) rule contains and release captive-bred birds into the range place it in danger of extinction at all the prohibitions and authorizations wild. We have incorporated this this time. necessary and advisable for the information in our analysis and Comment (16): One commenter conservation of the species. included a description of the disagrees with our determination that Comment (18): One commenter reintroduction efforts for A. m. disease could be introduced through asserts that the Service’s statement that cyanoptera and A. m. macao in their reintroduction programs that may affect northwest Colombia has large tracts of respective ranges. See ‘‘Reintroduction wild populations of scarlet macaws. The forest suitable for supporting a presently of Scarlet Macaws,’’ below. commenter stated that disease does not unknown scarlet macaw population and Comment (20): One commenter claims pose a risk to wild populations, could contribute to the resiliency and that listing of the southern DPS of A. m. especially in northern Central America, redundancy of the DPS is both macao based on similarity of and cited Boyd and McNab 2008. speculative, because it is unknown if appearance alone is not warranted in

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the absence of any potential threat to throughout all or a significant portion of separating the yellow and blue as in wild populations. The movement of the its range (16 U.S.C. 1532(20)). A. m. macao. southern DPS of A. m. macao would be We summarize below the information The subspecies classification subjected to extensive permitting and on which we based our final described by Wiedenfeld (1994, entire) reviews under CITES and the WBCA, so determination and evaluation of the five is used in the scientific community and listing it under the Act would provide factors provided in section 4(a)(1) of the the subspecies are recognized by the little extra protection. Act. We are also adopting a rule Integrated Taxonomic Information Our Response: During the public authorized under section 4(d) of the Act System (ITIS) as valid taxa (ITIS 2011, unpaginated). The subspecies comment period for the proposed rule for the scarlet macaw to further its classification is supported by genetic (77 FR 40222; July 6, 2012), we received conservation. We find this rule contains analyses (Schmidt 2011, pers. comm.; additional information supporting a the prohibitions and authorizations similarity of appearance listing for the Schmidt and Amato 2008, pp. 135–137). necessary and advisable for the Schmidt (2013) represents the only southern DPS of A. m. macao and conservation of the scarlet macaw. scarlet macaw subspecies crosses spatial analysis of scarlet macaw genetic between A. m. cyanoptera and A. m. Species Information variation across the historical range of the species, and we consider this study macao, which we incorporated into the Species Description to be the best available information on revised proposed rule (81 FR 20302; the range of the two subspecies. April 7, 2016) and carry forward in this The scarlet macaw (Ara macao) is one Therefore, the mainland Central final rule. Because it can be difficult to of several large neotropical parrot America boundary between A. m. visually differentiate between the two species commonly referred to as cyanoptera and A. m. macao is the subspecies and this difficulty is an macaws. They measure 84–89 central mountain range of Costa Rica, additional threat for the northern DPS of centimeters (33–35 inches) in length, with A. m. cyanoptera found on the A. m. macao, we determined that weigh 900–1490 grams (2.0–3.3 Caribbean (eastern) slope of the country treating the southern DPS of A. m. pounds), and are one of the larger and A. m. macao on the Pacific macao under the Act’s section 4(e) macaws (Collar 1997, p. 421). Scarlet macaws are brilliantly colored and (western) slope. Additionally, scarlet similarity of appearance provisions will macaws on Isla Coiba are likely to be the substantially facilitate law enforcement predominantly scarlet red; most of the head, body, tail, and underside of the subspecies A. m. cyanoptera. actions to protect and conserve scarlet Consequently, we consider scarlet macaws. Extending the protections of wings are red. Color on the upper side of the wing appears generally as bands macaws in Mexico, Guatemala, the Act to the similar entities through Nicaragua, Honduras, the Caribbean this listing of those entities due to of red, yellow, and blue, with varying amounts of green occurring between the slope of Costa Rica, and Isla Coiba in similarity of appearance under section Panama to be A. m. cyanoptera. We 4(e) of the Act and providing applicable yellow and blue band. Lower back, rump, and tail coverts (upper tail consider birds on the Pacific slope of prohibitions and exceptions in a rule Costa Rica and southward through the issued under section 4(d) of the Act will feathers) are blue. The species has large white, mostly bare facial patches on remainder of the species’ range in South provide greater protection to A. m. America to be A. m. macao (see Figure cyanoptera and the northern DPS of either side of its bill. The upper bill is a light, whitish color, whereas the lower 1, below). A. m. macao. For these reasons, we are The data also show genetic bill is black. The sexes are similar, and treating the southern DPS of A. m. differentiation between A. m. macao immature birds are similar to adults, macao as threatened due to the that occur on either side of the Andes except immature birds have shorter tails similarity of appearance to the northern in South America, indicating two (Collar 1997, p. 421; Wiedenfeld 1994, DPS of A. m. macao, pursuant to section populations: One consisting of birds p. 100; Forshaw 1989, pp. 404, 406). 4(e) of the Act. Furthermore, simply west of the Andes in northwest being protected by CITES and the Taxonomy Colombia, mainland Panama, and WBCA does not preclude the need to Pacific slope of Costa Rica; and the list and provide additional protections The scarlet macaw was first described other population consisting of birds east under the Act. Listing under the Act in 1758, by Linnaeus (Collar 1997, and south of the Andes and throughout helps ensure that the United States and p. 421; Wiedenfeld 1994, p. 99). In 1994, the species’ South American range its citizens do not contribute to the the subspecies Ara macao cyanoptera, (Schmidt 2011, pers. comm.). further decline of the species. was separated from the originally described taxon (or nominate form), Range Background A. m. macao (Wiedenfeld 1994, entire). The range of the scarlet macaw is the Section 4 of the Act (16 U.S.C. 1533) Ara macao cyanoptera occurs from broadest of all the macaw species and the implementing regulations in southern Mexico south to central (Ridgely 1981, p. 250). Extending from part 424 of title 50 of the Code of Nicaragua. Birds from southern Mexico southward to central Bolivia Federal Regulations (50 CFR part 424) Nicaragua to northern Costa Rica and Brazil, it covers an estimated set forth procedures for adding species represent a zone of intergradation 7,030,975–10,200,000 square kilometers to, removing species from, or between the two forms; the nominate (km2) (2,714,675–3,938,242 square miles reclassifying species on the Federal form (A. m. macao) occurs from this (mi2)) (BirdLife International (BLI) 2018, Lists of Endangered and Threatened zone southward through the South unpaginated; Vale 2007, p. 112). The Wildlife and Plants. The Act defines American range of the species majority (83 percent) of the species’ ‘‘endangered species’’ as any species (Wiedenfeld 1994, pp. 100–101). Ara range lies within the Amazon Biome of that is in danger of extinction macao cyanoptera is different from A. South America (BLI 2011a, unpaginated; throughout all or a significant portion of m. macao in size and wing color; A. m. BLI 2011b, unpaginated; BLI 2011c, its range (16 U.S.C. 1532(6)), and cyanoptera is larger than A. m. macao, unpaginated). ‘‘threatened species’’ as any species that with significantly longer wing lengths; Historically, the range of the scarlet is likely to become an endangered and the yellow wing coverts that are macaw included the southern portion of species within the foreseeable future tipped in blue have no green band the Mexico state of Tamaulipas

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southward through the states of (Forshaw 1989, p. 407; French 1973, p. and Chiquibil, in southwest Belize; in Veracruz, Oaxaca, Tabasco, Chiapas, 76). The species may occur in that the Mosquitia region of eastern and Campeche; all of Belize; the Pacific country as a very occasional vagrant or Honduras and Nicaragua; in the border and Caribbean slopes of Guatemala, an escapee from captivity (Forshaw region of southeastern Nicaragua and Honduras, Nicaragua, El Salvador, and 1989, p. 407). northeastern Costa Rica near the Rio San Costa Rica; the Pacific slope of Panama The scarlet macaw’s range in Juan (San Juan River); the A. m. macao and Costa Rica; the Magdalena Valley in Mesoamerica (Mexico and Central occurs in Palo Verde in northwestern Colombia; and that part of South America) has been reduced and Costa Rica; Carara National Park and fragmented over the past several America within Colombia, Ecuador, surrounding area, in west-central Costa decades primarily as a result of habitat Peru, Venezuela, Suriname, Guyana, Rica; the Osa Peninsula and destruction and harvesting the species surrounding area, Costa Rica; and in French Guiana, and Bolivia and Brazil for the pet trade (Vaughan et al. 2003, as far south as Santa Cruz and northern pp. 2–3; Collar 1997, p. 421; Wiedenfeld western border region of Panama and Mato Grosso, respectively (Wiedenfeld 1994, p. 101; Snyder et al. 2000, p. 150). Costa Rica in the Chiriquı´ province and 1994, pp. 100–101; Forshaw 1989, p. It has been extirpated from almost all of on the southern end of the Azuero 406; Ridgely 1981, p. 250; In˜ igo-Elias its former range in Mexico, all of its Peninsula and Isla Coiba, Panama. In 2010, p. 8). Some authors report the former range in El Salvador, and much South America, the A. m. macao occurs native range of the species to include of its former range throughout Central in small areas outside the Amazon west Trinidad and Tobago (BLI 2011d, America. of the Andes in northwest Colombia and unpaginated; Forshaw 1989, p. 406). Currently, in Mesoamerica, the A. m. in parts of several northern Venezuelan However, the historical record consists cyanoptera occurs in the Maya Forest states. Within the Amazon, the scarlet of only two questionable site records of region of eastern Chiapas, in Mexico, macaw still occurs over much of its the species in Trinidad and Tobago western Pete´n, in northern Guatemala, historical range (see Figure 1, below).

Distribution and Abundance cyanoptera (occurring from southern recently, the current population of A. m. Mexico to Nicaragua and Isla Coiba, cyanoptera was estimated to be fewer Using 1992 estimates from Honduras, Panama), and 1,000 A. m. macao than 1,000 birds (McNab 2009, p. 1). and extrapolating from these estimates, (northern DPS and occurring in Costa The known populations of scarlet the total number of scarlet macaws in Rica and mainland Panama) macaw in their range countries are Mesoamerica is approximately 5,000 (Wiedenfeld 1994, p. 102). More described below (see Table 1). All the birds, consisting of 4,000 A. m.

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population estimates are of birds, except Mexico, in which breeding pairs were estimated.

TABLE 1—SCARLET MACAW POPULATIONS THROUGHOUT ITS RANGE [Estimates are individuals unless otherwise stated]

Population range country Population name Population estimates

Ara macao cyanoptera: Southeast Mexico ...... upper Rio Uxpanapa region; Usamacinto Wa- ∼50; < 200 breeding pairs. tershed—Eastern Chiapas, Mexico, Lacando´n Forest. Guatemala ...... Northern Pete´n ...... 150–250. Belize ...... Chiquibul ...... 60–219. Eastern Honduras, Northeastern Nicaragua Mosquitia Region ...... Honduras: 1,000–1,500; Nicaragua: <100– 700. Southeast Nicaragua Border and Northeast Rio San Juan (San Juan-La Selva/San Juan- possibly >200. Costa Rica. El Castillo). Isla Coiba, Panama ...... Isla Coiba ...... 100–200.

Total A. m. cyanoptera ...... 2,000–3,000. Ara macao macao Northern DPS: Cerro Hoya National Park ...... Mainland Panama ...... <25. Costa Rica ...... Central Pacific Conservation Area (ACOPAC) ∼450. Costa Rica ...... Osa Conservation Area (ACOSA) ...... 800–1,200; up to 2,000. Northwest Colombia ...... Northwest Colombia ...... unknown.

Total A. m. macao Northern DPS ...... 1,000–2,000.

Total Mesoamerica ...... 3,000–5,000. Ara macao macao Southern DPS: Amazon, south and east of the Andes Amazon ...... 15,000–45,000. Mountains (Colombia, Ecuador, Peru, Venezuela, Suriname, Guyana, French Guiana, and Bolivia and Brazil).

Total Ara macao ...... ∼20,000–50,000.

Mesoamerica Forest, which is the largest remaining 2011, in litt., unpaginated; McNab 2009, expanse of tropical rainforest in the p. 1). Estimates from Belize vary from 60 Mexico, Guatemala, and Belize (Maya Americas (The Nature Conservancy to 219 individuals, but based on field Forest) (A. m. cyanoptera) 2018, unpaginated), and includes the observations in 2009, the current Belize Described as previously abundant in Montes Azules Biosphere Reserve population is estimated at 200 Mexico (CONABIO 20l1, p. 2) and (approximately 3,000 km2 (1,158 mi2), individuals (McReynolds 2011, in litt., numbering in the many thousands several smaller protected areas, and the unpaginated). However, the total (Patten et al. 2010, p. 30), the A. m. municipality of Maques de Commillas population in the tri-national Maya cyanoptera is now reported to occur in (United Nations Educational, Scientific, region (Mexico, Guatemala, and Belize), only two small populations in Mexico. and Cultural Organization (UNESCO) based on habitat modeling and current One population occurs in the upper Rio 2012a, unpaginated; McReynolds 2011, threats, was estimated to be 399 Uxpanapa region near San Francisco La in litt.; Enriquez et al. 2009, p. 13; individuals—137 in Mexico, 159 in Paz in Oaxaca (Inigo-Elias 1996, pp. 16– Castillo-Santiago et al. 2007, pp. 1215, Guatemala, and 103 in Belize (Garcia et 17). Citing several sources, Inigo-Elias 1217; Inigo-Elias 1996, pp. 16–17, 23); al. 2008, pp. 52–53). (2010, unpaginated) and McReynolds (2) in the western Department of Pete´n Populations in Mexico, Guatemala, (2011, in litt., unpaginated) indicate that in northern Guatemala, primarily in the and Belize are described as not being the upper Uxpanapa River population Maya Biosphere Reserve (MBR) (Garcia completely isolated from one another. It consists of possibly 50 scarlet macaws. et al. 2008, pp. 49–64; McNab 2009, p. is likely that the population in western It is possible that the species may occur 1); and (3) in southwest Belize, where it Pete´n, Guatemala, and the population in seasonally in this area (Peterson et al. is known to breed only in the Chiquibul southeastern Mexico are connected 2003, p. 232). The second population region, which includes Chiquibul because there is continuous habitat and that occurs in Mexico is along the National Park and other protected areas the birds from Guatemala, when they southern Mexico and Guatemala border (Salas and Meerman 2008, p. 42). disperse in the non-breeding season, are area of eastern Chiapas, and is discussed Based on field studies conducted from known to go to the west of their below. 1989 to 1993, it was estimated that breeding grounds (Brightsmith 2016, in Within the tri-national region of probably fewer than 200 breeding pairs litt. p. 8). In a radio telemetry study, a southern Mexico, northern Guatemala, exist within Mexico’s Usamacinto fledgling radio-tagged in Guatemala flew and Belize, the species occurs in three watershed (In˜ igo-Elias 1996, pp. 96–97). 130 km (81 mi) to Mexico in one day small populations or subpopulations: (1) In Guatemala, the population is (McReynolds 2011, in litt., In the Usamacinto watershed in eastern estimated at 150 to 250 birds (McNab unpaginated). In addition, studies Chiapis, Mexico, located in the 2008, p. 7; Wildlife Conservation provide evidence of gene flow between Lacandon forest that is within the Maya Society Guatemala 2005, in McReynolds nest sites in Guatemala and Belize, and

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high levels of genetic diversity in the tri- the species in this region (Portillo Reyes was conducted on both sides of the Rı´o national region (Schmidt and Amato 2005, in Portillo Reyes et al. 2010, p. 6; San Juan as part of a larger study to 2008, p. 137). However, the Belize Brightsmith in litt. 2016, p. 8). quantify and characterize nests of both population may be more isolated from scarlet and great green macaws (Monge Nicaragua (A. m. cyanoptera) the Guatemala and Mexico populations et al. 2012, entire). They found six because the area between these Scarlet macaws in eastern Nicaragua scarlet macaw nests (five in Costa Rica, populations is well covered by eBird along the Caribbean slope were one in Nicaragua). The scarlet macaw observers and no scarlet macaws have estimated to be 1,500 to 2,500 birds in has recently expanded its range been seen even though there is high- 1995 (Wiedenfeld 1995, in Snyder et al. southward to La Selva Biological quality habitat (Brightsmith in litt. 2016, 2000, p. 150). However, the species was Station, which is approximately 35–40 unpaginated). not detected during either of two km (15–18 miles) south of the Rı´o San national surveys of parrots conducted in Juan, and sightings of scarlet macaws Honduras (A. m. cyanoptera) 1999 and 2004 (Lezama et al. 2004, p. have increased in the region The scarlet macaw was widespread in 102; McReynolds 2011, in litt., (Brightsmith 2016, in litt., p. 5; Sullivan Honduras, occurring in the arid unpaginated). Some estimates predict et al. 2009, unpaginated). Scarlet lowlands of the Pacific slope and the up to 700 birds in this region of macaws were absent from this station interior below 1,100 m (3,609 ft), as well Nicaragua; groups of 30 to 40 scarlet since it was established in the 1960s, as in the Caribbean lowland rainforest macaws are frequently reported in the but they have been observed breeding (Monroe 1968, p. 139). The scarlet Rı´o Coco area (Lezama 2011, pers. on adjacent land since the mid-2000s macaw may have had a distribution over comm., in McReynolds 2011, in litt., (Brightsmith 2012, in litt., unpaginated). 60 percent of the national territory at the unpaginated), which forms the border Approximately 50 scarlet macaws occur end of the 19th century (Monroe 1968, with Honduras. Others consider the in Maquenque National Wildlife Refuge p. 139; Portillo Reyes et al. 2010, p. 69). number in eastern Nicaragua to be fewer in northeast Costa Rica (Penard et al. Currently, the scarlet macaw is than 100 birds (Feria and de los 2008, in McReynolds 2011 in litt., restricted to the Mosquitia region, Monteros 2007, in McReynolds 2011, in unpaginated). There are no density which is a region of extensive forest litt., unpaginated)). The only scarlet estimates of scarlet macaws from this straddling the southeastern Honduras- macaws on the Pacific slope of area, but based on the density reported northeastern Nicaragua border Nicaragua are confined to Cosigu¨ ina for great green macaws (0.07 birds per (Wiedenfeld 1994, pp. 101–102; Portillo Volca´n Nature Preserve, with km2) in an area of 3,000 km2 (1,158 Reyes 2005, p. 71). This region includes approximately 20 to 50 birds (Bjork mi2), there could be more than 200 several thousand square kilometers in 2008, p. 15; Lezama 2011, pers. comm., scarlet macaws in northeastern Costa protected areas, such as the Pla´tano in McReynolds 2011, in litt., Rica (Brightsmith in litt. 2016, p. 6; Biosphere Reserve (5,000 km2 (1,931 unpaginated). Brightsmith 2012, in litt., unpaginated). mi2)) Reserva de la Biosfera Tawahka Costa Rica (A. m. cyanoptera and A. m. Scarlet macaws were described as (Tawahka Biosphere Reservation) (2,500 macao) having previously occurred in tropical km2 (965 mi2)), the Parque Nacional wet and dry forests throughout most of Patuca (Patuca National Park) (3,755 Scarlet macaws (A. m. cyanoptera) Costa Rica (Vaughan et al. 1991, km2 (1,450 mi2)) in Honduras, and the occur in southeastern Nicaragua and abstract), while Ridgely (1981, p. 252) Bosawa´s Biosphere Reserve (21,815 km2 northeastern Costa Rica on both sides of describes the species as having always (8,423 mi2)) in neighboring Nicaragua the border. This region consists of the El occurred primarily on the Pacific slope (UNESCO 2012b, unpaginated; UNESCO Castillo-San Juan-La Selva Biological of the country. Aside from the birds in 2012c, unpaginated; Vallely et al. 2010, Corridor that is located on both sides of northeastern Costa Rica, the scarlet p. 52). the Rı´o San Juan (San Juan River) macaw (A. m. macao) occurs in two The total population of Honduras was (Monge et al. 2012, p. 6), which viable populations on the Pacific slope: estimated at 1,000 to 1,500 birds in separates Nicaragua and Costa Rica. In In the ACOPAC in the region of Carara 1992, reportedly occurring in the Colo´n 2004, several groups of scarlet macaws National Park, which contains area and provinces of Olancho and were reported in the Rı´o San Carlos area approximately 450 birds (Arias et al. Gracias a Dios that are in the Mosquitia close to the border with Nicaragua, in 2008, in McReynolds 2011, in litt.); and region of Honduras (Wiedenfeld 1994, what is now designated as Maquenque in Costa Rica’s Osa Conservation Area pp. 101–102). An estimate of scarlet National Wildlife Refuge (Refugio (ACOSA) in the region of Corcovado macaws in the Rus Rus area of the Nacional de Vida Silvestre mixto National Park and the Osa Peninsula, Honduran Mosquitia (Rus Rus is in the Maquenque), which also abuts the Indio which contains between 800 and 1,200, province of Gracias a Dios) was 1,000 to Maı´z Biological Reserve in Nicaragua but possibly up to 2,000 birds (Dear et 1,500 birds (McReynolds 2011, in litt., (Chassot and Monge-Arias 2004, pp. 12– al. 2005 and Guzman 2008, in unpaginated). However, this estimate 13; Chassot 2011, pers. comm.). McReynolds 2011, in litt.). However, was based on the assumption that all the Multiple scarlet macaws were observed based on plausible regional estimates, chicks reported as poached by Portillo flying from Nicaragua over the Rı´o San the population for the entire country is Reyes et al. (2004, in McReynolds 2011, Juan into Costa Rica (Chassot and approximately 1,800 birds (McReynolds in litt., unpaginated) would fledge and Monge-Arias 2004, pp. 12–13). 2011, in litt., unpaginated). assumed a 20 percent reproductive Evidence of scarlet macaws in By all indications, the scarlet macaw success rate. There are no population northeast Costa Rica obtained during (A. m. macao) has been expanding from estimates for the Rı´o Patuca and Rı´o several years of research on great green the traditional stronghold in and around Pla´tano areas, though there have been macaws (Ara ambiguus) indicates that Carara National Park (Brightsmith 2016, flocks as large as eight counted on the scarlet macaws in this region are in litt., p. 11). Since 2013, scarlet Rı´o Pla´tano (Gallardo 2002, in increasing (Chassot and Monge-Arias macaws in groups of up to 30, along McReynolds 2011, in litt., unpaginated). 2004, pp. 12–13; Brightsmith 2012, in with pairs during the height of the The most recent information indicates litt., unpaginated). During the 2009 breeding season, were observed that loss of habitat and demand for the scarlet macaw breeding season, an hundreds of times down the coast and pet trade pose a substantial threat for intensive search for scarlet macaw nests approximately 70 km (43 mi) south of

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the point where the census is usually unpaginated). In 1998, there were Tambopata population was calculated to conducted. In addition, scarlet macaws sporadic sightings of scarlet macaws in number from 4,734–24,332 individuals. from the areas immediately to the the western border region of Panama The population of scarlet macaws in northwest of Carara have been reported. and Costa Rica, in the area of the upper Peru is adjacent to large populations in Scarlet macaws may frequently pass Rı´o Corotu (or Rı´o Bartolo Arriba) near adjacent Ecuador, Brazil, Bolivia, and through these areas but may not be Puerto Armuelles in the Chiriquı´ Colombia (Brightsmith 2009, in litt., present continuously or at high province (Burica Press 2007, unpaginated). Therefore, the total densities (Brightsmith 2016, in litt., p. unpaginated; McReynolds 2011, in litt., individuals could represent scarlet 12). The nearest areas with repeated unpaginated). A few (fewer than 10) macaws from more than just Peru. sightings of the species are Ensenada scarlet macaws were observed in 2015, The remaining information on the Lodge at 60 km (37 mi) north of the in northwestern Panama, near species’ populations in South America census location for Carara; 40 km (25 Querevalo and also in the Chiriquı´ is qualitative. In Colombia, the species mi) from the small population of 14–25 province (Brightsmith in litt. 2016, p. is believed to occur west of the Andes birds in Palo Verde (Brightsmith 2016, 17; Sullivan et al. 2009, unpaginated), in the Magdalena Valley and in gallery in litt., p. 12; Dear et al. 2010, p. 8); and but it is uncertain if these birds were forest and partially cleared rainforest 60 km (37 mi) from the core of the wild or escaped captively-raised birds where large trees have been left (Hilty ACOPAC population. This site has 16 dispersing south from a reintroduction and Brown 1986, p. 200; Forshaw 1989, sightings, with 13 since 2012, and group program at Tiskita, Costa Rica p. 407); their presence may be the result sizes have been small (1 to 4). But it is (Brightsmith 2016, in litt., p. 17) (see of seasonal movements for food unclear what the source of these birds ‘‘Reintroduction of Scarlet Macaws,’’ resources (Juniper and Parr 1998, p. may be; they could be escaped or below). Additionally, there is a small, 425). The species is also common east released birds, or could be natural but unknown, number on the southern of the Andes and in the Orinoco and dispersers from either the Palo Verde or end of the Azuero Peninsula of Amazon Basins in Colombia, but there ACOPAC populations (Brightsmith Veraguas, near Cerro Hoya National are no current population estimates 2016, in litt., p. 14). Because there have Park, Tonosi Forest Reserve, and farther (Hilty and Brown 1986, p. 200; In˜ igo- been scattered sightings of scarlet to the east (Brightsmith 2016, in litt., p. Elias 2010, unpaginated). In Venezuela, macaws from Palo Verde National Park 17; Sullivan et al. 2009, unpaginated; the species is becoming rare with patchy south to Carara National Park and Rodriguez and Hinojosa 2010, in distribution in the states of Bolı´var, throughout western Guanacaste, the McReynolds 2011, in litt., unpaginated). Monagas, Apure, and Amazonas (In˜ igo- birds near Palo Verde are no longer The current population of scarlet Elias 2010, unpaginated; Meyer de considered completely isolated macaws in Panama is likely less than Schauensee and Phelps, Jr. 1978, p. 99; (Brightsmith 2016, in litt., p. 14). 200, with the vast majority of the Juniper and Parr 1998, p. 425); there are However, evidence to support population occurring on Isla Coiba no current population estimates. The successful expansion and establishment (Keller and Schmitt 2008, in species has been described as occurring to the north is weak (Brightsmith 2016, Brightsmith 2012, in litt. and widely throughout the Amazon basin of in litt., p. 13). McReynolds 2011, in litt., unpaginated). The ACOSA population is Brazil, eastern Ecuador, and eastern simultaneously expanding up the coast South America (A. m. macao) Peru (Juniper and Parr 1998, p. 425). from the south, so sightings of scarlet Within South America, the scarlet However, more recently it was macaws between the ACOPAC and macaw occurs primarily in the Amazon described as uncommon, locally ACOSA may represent individuals from Biome, which overlaps eastern extirpated in areas, and declining in either of the populations. In fact, birds Colombia, Venezuela, Guyana, eastern Peru (Inigo-Elias 2010, were reported to occur in a 50-km (31- Suriname, French Guyana, northeast unpaginated). Citing several published mi) area, which is the midpoint between Ecuador, eastern Peru, northern Bolivia, works from the 1970s and 1980s, scarlet the two populations (Brightsmith 2016, and most of Brazil (collectively referred macaws were described as locally in litt., p. 11). Moreover, 85 percent of to as the Amazon in this document) (BLI extirpated from areas with a history of residents interviewed in 2005 believed 2011a, unpaginated; In˜ igo-Elias 2010, ornithological study in northeastern scarlet macaws were more abundant unpaginated; Juniper and Parr 1998, p. Ecuador and northeastern Bolivia than 5 years prior, suggesting this 425; Collar 1997, p. 421; Forshaw 1989, (Forshaw 1989, p. 407), although it has population may be increasing (Dear et pp. 406–407). The Amazon comprises also been described as occurring in al. 2010, p. 10). However, it is difficult approximately 83 percent of the species’ northern and eastern Bolivia in Santa to distinguish between expansion of the entire range (BLI 2011c, unpaginated). Cruz (Juniper and Parr 1998, p. 425). ACOPAC population to the south and The scarlet macaw is also reported to Other authors reported that in recent the expansion of the ACOSA population occur in relatively small areas outside decades scarlet macaws have rapidly to the north (Brightsmith 2016, in litt., the Amazon, including west of the declined in the lowland Ecuadorian p. 11). Andes in northwest Colombia (Hilty and Amazon in Ecuador (Ridgely and Brown 1986, p. 200) and in parts of Greenfield 2001, in Karubian et al. 2005, Panama (A. m. macao) several northern Venezuelan states p. 618). The scarlet macaw occurs The scarlet macaw was once (Hilty 2003, p. 327). widely in the Guianas, which includes described as almost extinct on the We are aware of little recent Guyana, Suriname, and French Guiana mainland of Panama, but abundant and information on local (country, region) (Juniper and Parr 1998, p. 425), occurring in substantial numbers on Isla populations within South America. The although the species may be uncommon Coiba, which once was a penal colony only local population estimate we are in the vicinity of settlements (Forshaw where settlement and most hunting was aware of includes the Tambopata 1989, p. 407). In Suriname, scarlet prohibited (Ridgely 1981, p. 253). More Province of Peru (Lloyd 2004, p. 270). macaws are common in the interior recent information on distribution and Using density estimates calculated from rainforest but seldom seen in the coastal abundance in the country indicates that field counts in different forest types, area and are rare in the eastern part of mainland Panama has very few scarlet and area of forest cover presented in the country (Spaans et al. 2018, macaws (McReynolds 2011, in litt., Kratter (1995, in Lloyd 2004, p. 269), the unpaginated). Other sources indicate

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that the species is found along tropical remnant patches of rainforest (Vaughn Collar 1997, pp. 296, 298; Munn 1992, riparian evergreen forests in western et al. 2009, p. 396; Forshaw 89, p. 407); pp. 53–56). and central Suriname (Haverschmidt and areas of human settlement (towns) Scarlet macaws are secondary cavity- and Mees 1994, in In˜ igo-Elias 2010, (Guittar et al. 2009, p. 390). However, nesting birds, meaning they do not unpaginated). In Brazil, the species is the species occurs at lower densities in create their own cavities but rely upon widely distributed throughout the disturbed or secondary (recovering) natural or abandoned cavities for Amazon, but there are no current forest habitat than in primary nesting; their breeding success is population estimates (In˜ igo-Elias 2010, (undisturbed) forest (Cowen 2009, pp. dependent upon the availability and unpaginated; Juniper and Parr 1998, p. 11–15; Karubian et al. 2005, pp. 622– quality of nesting sites. They nest in 425). 623; Lloyd 2004, pp. 269, 272). both live and dead trees and in a variety Overall, the scarlet macaw is of tree species, including, but not Diet and Foraging generally considered common and limited to, Ceiba pentandra (kapok widespread over much of its range in Scarlet macaws, like most parrots, tree), Schizolobium parahybum the Amazon (Hilty 2003, p. 327; Angehr feed primarily in the canopy (Vaughan (Brazilian firetree), Vatairea lundellii et al. 2001, p. 161; Juniper and Parr et al. 2006, p. 920; Renton 2006, p. 282; (bitter angelim), Caryocar costaricense 1998, p. 425; Collar 1997, p. 421; Lee 2010, p. 20) and display a wide (no common name), Acacia glomerosa Forshaw 1989, p. 406; Hilty and Brown dietary breadth. They have been (white tamarind), Dipteryx micrantha 1986, p. 200; Ridgely 1981, p. 251). reported to consume up to 52 plant (Brazilian teak), Iriartea deltoidea (stilt Using the estimate of 20,000–50,000 species in the Amazon of Peru (Gilardi palm), and Erythrina spp. (coral tree) birds for the total population, and the 1996, in Matuzak et al. 2008, p. 361) and (Guittar et al. 2009, pp. 389–399; Renton estimate of 5,000 birds in Mesoamerica, up to 43 different plant species in Costa and Brightsmith 2009, pp. 3–4; the South American population of the Rica (Vaughan et al. 2006, p. 920; Brightsmith 2005, p. 297; Vaughan et al. scarlet macaw can be very roughly Matuzak et al. 2008, p. 355). Fruits and 2003, p. 8; In˜ igo-Elias 1996, p. 57; estimated to be 15,000–45,000 birds. seeds comprise the majority of a scarlet Marineros and Vaughan 1995, p. 456; macaw’s diet, but they also consume, to Nycander et al. 1995, p. 431). Due to Essential Needs of the Species a lesser degree, fruit pulp, flowers, their large size, scarlet macaws require Habitat leaves, bark, lichen, and bromeliads large cavities, which are usually found (Lee 2010, pp. 153–160; Matuzak et al. in older trees. The average height of The scarlet macaw inhabits various 2008, p. 355; Renton 2006, p. 281; scarlet macaw nests ranges from about habitat types throughout its range, Vaughan et al. 2006, pp. 920, 924; 16 to 24 m (52.5 to 79 ft) above the including tropical humid evergreen Marineros and Vaughan 1995, pp. 451– ground (Guittar et al. 2009, pp. 389–391; forest, deciduous and humid forest, 452; Nycander et al. 1995, p. 424). Anleu et al. 2005, p. 44; Inigo-Elias intact and partially cleared lowland rain Plant species consumed by scarlet 1996, p. 59; Marineros and Vaughn forest, mixed pine and broad-leaved macaws are both seasonal and available 1995, p. 455). In addition to cavity size woodlands, open areas and edges with year round (Abramson et al. 1995, p. and height parameters, scarlet macaws scattered stands of tall trees, gallery 24). Changes in local abundance appear to select nest sites with a clear forest, mangroves, and savannas, with patterns of parrots can be triggered by understory or isolated from surrounding many of the areas that scarlet macaw seasonal availability of food resources vegetation, possibly to reduce predation inhabit near rivers (Juniper and Parr within habitat mosaics (Renton 2002, p. rates (Inigo-Elias 1996, p. 93; 1998, p. 425; Wiedenfeld 1994, p. 101; 17; Haugaasen and Peres 2007, p. 4179). Brightsmith 2005, p. 302). The species Forshaw 1989, p. 407; Meyer de Fluctuations in food abundance are will also nest in previously used Schauensee and Phelps, Jr. 1978, p. 99). likely to result in seasonal movements cavities (Renton and Brightsmith 2009, The species generally occurs from sea of scarlet macaws to areas with greater pp. 4–5; Nycander et al. 1995, p. 428), level to about 500 meters (m) (1,640 feet food availability (Karubian et al. 2005, and will readily investigate and nest in (ft)) elevation, but has been reported p. 624; Haugaasen and Peres 2007, pp. artificial (human-made) cavities when ranging up to 1,500 m (4,921 ft) in 4179–4180; Renton 2002, pp. 17–18; supplied (Brightsmith 2005, p. 297; Central America (Juniper and Parr 1998, Juniper and Parr 1998, p. 425). Vaughan et al. 2003, p. 10; Nycander et p. 425; Vaughan 1983, in Vaughan et al. Additionally, in some areas of the al. 1995, pp. 435–436). 2006, p. 919). scarlet macaw’s range, they regularly Scarlet macaws are frequently The scarlet macaw is considered visit claylicks (naturally forming wall of observed competing for nest cavities somewhat tolerant of degraded or clay on a riverbank) where they with other macaws, including other fragmented habitat (BLI 2011c, consume soil or minerals; it is unclear species and other scarlet macaw pairs unpaginated; Forshaw 1989, p. 406; whether this provides a nutritional or (Renton and Brightsmith 2009, p. 5; Brightsmith in litt. 2016, pp. 4–7). If not other benefit to the species such as Vaughan et al. 2003, p. 10; Inigo-Elias hunted or captured for the pet trade, counteracting toxins in food sources 1996, pp.79, 96; Nycander 1995, p. 428). they can survive in human-modified (Brightsmith et al. 2010, entire; Thus, intense competition for nest landscapes provided sufficient large Brightsmith 2004, pp. 136–137; Lee cavities suggests suitable nesting sites trees remain for nesting and feeding 2010, p. 141). may be limited in some areas (Vaughan requirements (BLI 2011c, unpaginated; et al. 2003, pp. 10–12; Inigo-Elias 1996, Nesting and Reproduction Forshaw 1989, p. 406; Ridgely 1981, p. p. 92; Nycander et al. 1995, p. 428; 251). Landscapes may include a Reproductive biology of large parrots, Munn 1992, pp. 55–56). combination of agricultural land, including the scarlet macaw, is pastureland, timber harvesting areas, generally characterized by low rates of Conservation Status and remnant forest patches (Vaughn et reproduction, small clutch sizes, low The scarlet macaw has been included al. 2006, p. 920; Vaughan et al. 2005, p. survival of nestlings and fledglings, late in Appendix I of CITES since 1985 120; Vaughan et al. 2003, p. 7); partially age to first reproduction, a large (United Nations Environment cleared forest where large trees have proportion of nonbreeding adults in any Programme–World Conservation been left standing (Forshaw 89, p. 407); given year, and restrictive nesting Monitoring Center (UNEP–WCMC) pastureland with scattered woodlots or requirements (Wright et al. 2001, p. 711; 2012, unpaginated). The species is

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currently classified as ‘‘Least Concern’’ Factors Affecting the Species also contribute significantly and to by the IUCN. In 2011, BLI proposed Section 4 of the Act (16 U.S.C. 1533), varying degrees in different areas of the reclassifying the scarlet macaw in the and its implementing regulations in title species’ range (Blaser et al. 2011, pp. IUCN Red List of Threatened Species 50 of the Code of Federal Regulations at 263, 290, 299, 310, 319, 334, 343–344, from ‘‘Least Concern’’ to ‘‘Threatened,’’ 50 CFR part 424, set forth the 354, 363–364, 375, 393–394; Boucher et based on the area of Amazon habitat procedures for adding species to the al. 2011, entire; Clark and Aide 2011, projected to be lost to deforestation by Federal Lists of Endangered and entire; FAO 2011a, pp. 17–18; May et al. 2050 (BLI 2011b, unpaginated; BLI Threatened Wildlife and Plants. Under 2011, pp. 7–13; Pacheco 2011, entire; 2011e, unpaginated). However, based on section 4(a)(1) of the Act, we may list a Government of Costa Rica 2010, pp. 38– 39; Belize Ministry of Natural Resources review and recommendations from species based on (A) The present or and Environment 2010, pp. 40–45; regional experts, a current revision of threatened destruction, modification, or Armenteras and Morales 2009, pp. 133– the proposal recommends the species curtailment of its habitat or range; (B) 145, 176–191; Kaimowitz 2008, p. 487; remain classified as ‘‘Least Concern’’ overutilization for commercial, Mosandl et al. 2008, pp. 38–40; Nepstad due to its level of tolerance of degraded recreational, scientific, or educational et al. 2008, entire; Foley et al. 2007, pp. and fragmented habitat (BLI 2011c, purposes; (C) disease or predation; (D) 26–27; Fearnside 2005, pp. 681–683). unpaginated) and the relatively good the inadequacy of existing regulatory status of the species in the Amazon, The construction of roads are an mechanisms; or (E) other natural or important driver of deforestation which accounts for the majority of the manmade factors affecting its continued species range and population. because they provide access to existence. previously remote areas and allow In Mesoamerica, the northern In considering what factors may further expansion of activities that subspecies of scarlet macaw (A. m. constitute threats, we must look beyond result in additional areas of cyanoptera) is considered in danger of the mere exposure of the species to the deforestation and degradation (Davidson extinction in Mexico (Government of factor to determine whether the species et al. 2012, p. 323; Lambin and Mexico 2010a, p. 32), Belize responds to the factor in a way that Meyfroidt 2011, pp. 3468–3469; May et (Biodiversity and Environmental causes actual impacts to the species. If al. 2011, pp. 6, 9–11; Foley 2007, pp. Resource Data System of Belize 2012, there is exposure to the factor, but no 26–27; Soares-Filho et al. 2006, p. 520; unpaginated; Meerman 2005, p. 30), response, or only a positive response, Fearnside 2005, pp. 681–683; Laurance Costa Rica (Costa Rica Sistema Nacional that factor is not a threat. If there is et al. 2004, entire). Historically, large de Areas de Conservacion 2012, exposure and the species responds areas of forest have been removed unpaginated), and Panama (Fundacio´n negatively, the factor may be a threat throughout Mesoamerica, and the large de Parques Nacionales y Medio and we then attempt to determine if it tracts of forest that remain, such as the Ambiente 2007, p. 125). This subspecies may drive or contribute to the risk of Maya and Lacandon Forests, the is also on Guatemala’s Listado de extinction of the species such that the transnational forest in the Mosquitia Especies de Fauna Silvestre species warrants listing as an region, and the major transnational Amenazadas de Extincio´ n (Lista Roja de endangered or threatened species as forest on the Atlantic border of Costa Fauna) (list of species threatened with those terms are defined by the Act. In Rica and Panama, have almost been cut extinction (red list of fauna)) 2016, we revised our proposal to list the off from each other by deforestation (Government of Guatemala 2001, p. 15), northern subspecies of the scarlet (Bray 2010, p. 93). Honduras’s Listado Oficial de Especies macaw (Ara macao cyanoptera) as an Activities that lead to deforestation de Animales Silvestres de Preocupacio´ n endangered species under the Act, the and forest degradation pose a threat to Especial en Honduras (Official List of northern DPS of the southern subspecies the scarlet macaw because they directly Species of Wild Animals of Special Ara macao macao as a threatened eliminate the species’ tropical forest Concern in Honduras) (Secretaria de species under the Act, and the southern habitat by removing the trees that Recursos Naturales y Ambiente. 2008, p. DPS of the southern subspecies Ara support the species’ essential needs for 62), and Nicaragua’s list of species for macao macao as threatened due to nesting, roosting, and food (see Essential which the season of use (e.g., for harvest similarity of appearance under the Act Needs of the Species, above). Removing or capture) is indefinitely closed (81 FR 20302, April 7, 2016). Please see large sections of forest habitat may our analysis of those entities and the (Nicaragua Ministerio del Ambiente y fragment the landscape and reduce and factors affecting their status below. Los Recursos Naturales 2010, entire). isolate populations. As the size of the habitat is reduced, it is less likely to Factor A. The Present or Threatened In South America, the subspecies A. provide the essential resources for Destruction, Modification, or m. macao is listed as vulnerable in Peru species that require large ranges—such Curtailment of Its Habitat or Range (Government of Peru 2004, p. 276855), as scarlet macaws—and small patches of but a more recent evaluation of the One of the two main threats to habitat retain far fewer species and species categorizes it at the lower threat neotropical parrot species is loss of populations than large patches (Ibarra- level of ‘‘near threatened’’ (Brightsmith forest habitat (Snyder et al. 2000, p. 98). Macias 2009, p. 6; Lees and Peres 2006, 2009, in litt., unpaginated). The species Deforestation, which includes clear- pp. 203–205). Scarlet macaws use is also categorized as ‘‘near threatened’’ cutting forests to convert them to other partially cleared and cultivated in Ecuador (Ridgely and Greenfield land uses such as agriculture and cattle landscapes if the landscape provides 2001, in Karubian et al. 2005, p. 618) ranching, as well as forest degradation, dietary requirements and maintains and as ‘‘near threatened’’ on which is the reduction in forest biomass enough large trees. This species is Venezuela’s red list (Rodriguez and such as through selective logging or fire, dependent on larger, older trees that Rojas-Suarez 2008, p. 50). We are occurs throughout much of the scarlet have large nesting cavities. However, unaware of the scarlet macaw having macaw’s range. The primary cause of scarlet macaws have a better chance of official conservation status in any other forest loss is conversion to agriculture surviving in large tracts of forest where of the species’ range countries (e.g., (crop and pasture), although other land suitable cavities are more common than Colombia, the Guianas, Brazil, and uses such as infrastructure, logging, in open and small forest remnants Bolivia). fires, oil and gas extraction, and mining (Inigo-Elias 1996, p. 91). Selective

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logging can lead to forest degradation 1217; Oglethorpe et al. 2007, p. 85). (CCMSS 2007, in Enriquez et al. 2009, because this practice generally targets From 1990 to 2015, Mexico lost p. 57). older and larger trees, thus decreasing approximately 3.7 million hectares (ha) We are unaware of information on suitable nesting sites, increasing (9.2 million acres (ac)) of total forest projected future rates of deforestation competition, and causing the loss of (FAO 2015, p. 12) (see Tables 2a and 2b, specifically in the Lacandon Forest current generations through an increase below), and had one of the largest region, but a loss of approximately in infanticide and egg destruction (Lee decreases in primary forests worldwide 20,000 km2 (7,722 mi2) between 2000 2010, pp. 2, 12). Indirectly, clearing or (FAO 2010a, pp. 56, 233), although the and 2015 in the southeastern States degrading forests often provides people rate slowed toward the latter part of that (which include Chiapas) was projected, with easier access to previously period (FAO 2015, p. 12). assuming the same rate of loss that inaccessible areas inhabited by scarlet In southeastern Mexico, the area of occurred during the period 1987–2000 macaws, which in turn increases the land devoted to cattle ranching has (Diaz-Gallegos et al. 2010, p. 194). By vulnerability of species to increased dramatically due to the 2030, forest area in Mexico as a whole overexploitation by humans (Peres increase of regional meat prices and a is projected to decrease, with anywhere 2001, entire; Putz et al. 2000, pp. 16, 23) decrease in the economy of staple crop from about 10 to 60 percent of mature (see Factor B discussion, below). cultivation (Jimenez-Ferrer et al. 2008, forests lost, and up to 54 percent of Additionally, gaining access is also pp. 195–196; Soberanes 2018, regrowth forests lost (Commission for often followed by full deforestation and unpaginated). Most of Mexico’s Environmental Cooperation 2010, pp. lands cleared for agricultural use remaining scarlet macaws occur in the 45, 75). Mexico implements several forest (Kaimowitz and Angelsen 1998, in Putz Lacandon Forest of the southeastern conservation measures and has made et al. 2000, p. 16). state of Chiapas. This state encourages Below, we provide a summary of significant progress in conserving forest cattle ranching through subsidies, and information on deforestation and forest within its boundaries (Blaser et al. 2011, clearing of forest for pasture in the state degradation within the range countries pp. 344–346; Center for International is ongoing (Enriquez et al. 2009, pp. 48– of the A. m. cyanoptera and northern Forestry Research (CIFOR) 2010, pp. 34– 49, 58). In fact, Chiapas had the second DPS of A. m. macao. 36; Masek et al. 2011, p. 17; FAO 2010a, highest rate of deforestation of Mexico’s p. 233; Enriquez et al. 2009, pp. 4, 36– Mesoamerica 31 states, with forest losses averaging 41). However, deforestation and forest 2 2 Destruction of forest habitat is one of approximately 600 km (232 m ) per degradation continue to be a threat to the main causes of the decline of the year (Masek et al. 2011, p. 10). Within the subspecies in Mexico because the scarlet macaw in Mesoamerica the Lacandon Forest, cattle ranching is clearing of forest for agriculture, cattle (CONABIO 2011, p. 5; Lezama 2011, the most profitable activity, and it is ranching, and illegal logging is ongoing pers. comm.; McGinley et al. 2009, p. extensive in the region (Jimenez-Ferrer in Chiapas and projected to continue, 11; Garcia et al. 2008, p. 50; Hansen and et al. 2008, pp. 195–196). Outside of and illegal logging is ongoing in the Florez 2008, pp. 48–50; Snyder et al. protected areas in the Lacandon Forest, largest reserve in the Lacandon Forest in 2000, p. 150; Collar 1997, p. 421; the deforestation risk is primarily conjunction with the high risk of Forshaw 1989, p. 406; Ridgely 1981, pp. categorized as high to very high; inside deforestation in protected areas outside 251–253). Habitat destruction is protected areas the risk of deforestation of the forest. occurring rapidly in many areas within is categorized as low to very low the range of the scarlet macaw in this (Secretarı´a de Medio Ambiente y Guatemala, Belize, Honduras, and region, including in Chiapas, Mexico; Recursos Naturales de Me´xico— Nicaragua (A. m. cyanoptera) western Pete´n in Guatemala; eastern SEMARNAT 2011, unpaginated). Monte The countries of Guatemala, Olancho in Honduras; and eastern Azules Biosphere Reserve is the largest Honduras, and Nicaragua have the Nicaragua (Kaimowitz 2008, p. 487; protected area in the Lacandon Forest, highest deforestation rate in Latin Hansen et al. 2013, entire). This region and it has been relatively successful at America (FAO 2010a, p. 232; FAO 2015, has deforestation rates that are among conserving the resources within its pp. 9–14). Guatemala lost 483 km2 the highest rates in the world (Bray boundaries (Castillo-Santiago et al. (186.5 mi2 or 1.2 percent), Honduras 2010, pp. 92–95; Kaimowitz 2008, p. 2007, pp. 1223–1224; Figueroa and lost 1,418 km2 (547.5 mi2 or 2.3 487; Carr et al. 2006, pp. 10–11; FAO Sanchez-Cordero 2008, p. 3231). percent), and Nicaragua lost, 560 km2 2015, pp. 9–14); the remaining forest is However, according to Mexico’s Federal (216 mi2 or 1.5 percent) of total forest, fragmented and includes few large tracts Environmental Protection Agency per year between 1990 and 2015 (FAO of forest habitat (Bray 2010, pp. 92–93; (Procuradurı´a Federal de Proteccio´ n al 2015, pp. 9–14) (see Tables 2a and 2b, Snyder et al. 2000, p. 150; Wiedenfeld Ambiente (Profepa)) more than 60 below). Belize has a lower deforestation 1994, p. 101). Although deforestation percent of illegal logging in the country rate of 100 km2 (39 mi2 or 0.7 percent) rates have declined in Mesoamerica occurs in 32 priority forest regions, per year (FAO 2015, pp. 9), but since 1990, they are still very high (FAO including the reserve (Enriquez et al. deforestation is increasing in the 2010a, pp. 232–233; Kaimowitz 2008, p. 2009, pp. 28, 57). While illegal logging Chiquibul region, which is the only 487; FAO 2015, pp. 9–14) and include has received more attention from region scarlet macaws are known to nest the loss of significant amounts of Mexico’s policy makers, efforts to in the country (Belize Ministry of primary forest (FAO 2010a, pp. 55, 259). address the problem have had limited Natural Resources and Environment success due to insufficient human and 2010, pp. 44–45; Salas and Meerman Mexico (A. m. cyanoptera) financial resources to enforce laws, and 2008, pp. 22, 42). The main drivers of deforestation and poorly designed control efforts (Blaser et The main causes of deforestation and forest degradation in Mexico are al. 2010, p. 346; Enriquez et al. 2009, p. forest degradation within the range of conversion of forest to pasture and 57; Kaimowitz 2008, p. 491) (see Factor the scarlet macaw in these countries agriculture, and uncontrolled logging D discussion, below). From 2001 to include clearing for agriculture and (Government of Mexico 2010b, pp. 22– 2007, Profepa secured about 0.13 cattle ranching, illegal human 24; Jimenez-Ferrer et al. 2008, pp. 195– percent of the calculated total of timber settlements in protected areas, illegal 196; Castillo-Santiago et al. 2007, p. illegally extracted in the country logging, purposefully set fires, and in

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some areas, activities related to drug Considerable efforts have been made (7,725 ac) by 2007 (FCD 2007, in Belize trafficking. Some or all of these since the start of the 21st century to Ministry of Natural Resources and activities are ongoing in areas occupied reorganize the control and management Environment 2010, p. 45). Additionally, by the species, including in the MBR in of forest resources in Guatemala (Blaser more than 405 ha (1,000 ac) of freshly Guatemala; Rı´o Pla´tano Biosphere in et al. 2011, p. 317). In the rainforests of cultivated area was reported in the CNP Honduras; Bosawas Biosphere Reserve the Pete´n, large community-run timber and incursions into Belize by in Nicaragua; and the Chiquibul region concessions allow local people to Guatemalan armed forces have also been in Belize. improve their livelihoods on the basis of observed (FCD 2007, in Belize Ministry forest resources. However, forest of Natural Resources and Environment Guatemala (A. m. cyanoptera) management is hindered by high rates of 2010, p. 45). Unlike legal extraction, Guatemala has lost approximately 1.2 deforestation and forest degradation which can be regulated, illegal million ha (3 million ac) of forest area driven by agricultural expansion, extraction and particularly illegal over the past 25 years (FAO 2015, p. 11). mining, illegal logging, drug-trafficking, extraction by non-Belizean nationals Approximately 38 percent of and other threats (Blaser et al. 2011, p. continues to escalate, which poses a Guatemala’s remaining forest area is 317; Reynolds 2008, pp. 6–7). greater threat to forests than legal primary forest (FAO 2015, p. 36). extraction (Belize Ministry of Natural Belize (A. m. cyanoptera) Deforestation is the dominant trend Resources and Environment 2010, pp. nationally, but rates of loss appear to be Belize has a lower deforestation rate 42–45). Transboundary incursions, much higher in tropical over temperate (100 km2 (39 mi2, or 0.7 percent)) per while temporary, can have a severe areas. The most significant threat to the year than the other countries in impact on the forest because of the conservation of biodiversity and tropical Mesoamerica (FAO 2015, p. 9), but increase in demand for land for housing forests is habitat loss, degradation, and deforestation is increasing in the and farms, as well as the introduction or fragmentation from wildfires, Chiquibul region, which is the only reinforcement of unsustainable agriculture and cattle ranching, mineral region scarlet macaws are known to nest agricultural practices (Belize Ministry of and petroleum development, and drug in the country (Belize Ministry of Natural Resources and Environment trafficking (Tolisano and Lopez-Selva Natural Resources and Environment 2010, p. 42). 2010, p. 3). Deforestation in the conifer 2010, pp. 44–45; Salas and Meerman forests of the highlands has existed for 2008, pp. 22, 42). Belize lost 250,000 ha Honduras (A. m. cyanoptera) centuries, but today it mostly takes (618,000 ac) of total forest area over the Honduras lost approximately 3.5 place in the Pete´n (Blaser et al. 2011, p. past 25 years (FAO 2015, pp. 9, 40). million ha (8.7 million ac) of forest area 310) where a population of A. m. The Chiquibul National Park (CNP) is over the past 25 years (FAO 2015, p. 11) cyanoptera occurs. Approximately 65 Belize’s largest protected area, and had the highest rate of deforestation percent of the deforestation in measuring approximately 161,874 ha in the Americas (see Tables 2a and 2b, Guatemala occurs in the Pete´n region, (400,000 ac). It is located in the Cayo below). The Honduran forest landscape with most (approximately 60 percent) District and within a larger forest region is characterized by relative stability in occurring outside protected areas known as the Chiquibul Forest, which temperate areas with localized areas of (IARNA 2006, in Tolisana and Lopez- abuts the Belize-Guatemala border and variability in forest cover but with Selva 2010, p. 22). Additionally, the is contiguous to the Chiquibul- continuing deforestation in tropical Pete´n of Guatemala is one of the few Montan˜ as Mayas Biosphere Reserve that areas (Bray 2010, p. 104), especially in areas in the entire region that is still is located in the Department of Pete´n, the eastern tropical broadleaved forest undergoing intensive tropical Guatemala (Salas and Meerman 2008, p. (Blaser et al. 2011, p. 334; Humphries et colonization resulting in forest loss from 10). This region also includes the al. 1998, p. 99; Hansen and Florez 2008, agriculture and represents the most Chiquibul Forest Reserve and the p. 12). The most dramatic losses have intense deforestation threats to the Maya Caracol Archaeological Reserve. The been in the forests of the Atlantic Coast, Forest (Bray 2010, pp. 100–102). most significant pressure on the CNP, which declined by approximately 73 Colonization pressure in the MBR is the Chiquibul Forest, and biodiversity percent between 1962 and 1990, strong in the western and central within this region includes compared to only 30 percent loss for regions; the human population deforestation from urban encroachment, other broadleaf forests in the same increased 20-fold since 1960 and was agriculture expansion, wildfires, legal period (Humphries 1998, p. 99). predicted to double from 2008 to 2018 and illegal logging, illegal hunting, The high level of deforestation is due in the Pete´n (Bray et al. 2008, mining and oil exploration, and dam to illegal logging, infrastructure (e.g., unpaginated). construction (Salas and Meerman 2008, roads), institutionalized forest sector Habitat destruction is particularly pp. 45–46; Belize Ministry of Natural corruption, production of biofuels, and severe in two protected areas, Laguna Resources and Environment 2010, expanding agricultural frontiers del Tigre National Park and Sierra del p. 42). (although some of the latter may be Lacando´n National Park; both of these The border areas of Belize, including regarded as socially desirable) (Richards areas were former strongholds of scarlet the Chiquibul Maya Mountain that et al. 2003, p. 282). In the past, macaws (Garcia et al. 2008, p. 50). contains the CNP, Chiquibul Forest deforestation was due to agro-industrial Furthermore, some parks that compose Reserve, and Caracoal Archaeological development, mainly for banana the MBR lost approximately 10 percent Reserve, are vulnerable because plantations. However, more recently of forest cover between 1986 and 2004, insufficient enforcement resources are demand for land by small-scale farmers with forest loss thought to be available, particularly for Guatemalans is thought to be the major cause (ITTO accelerating (Bray 2010, p. 100). who are impacting forested areas on the 2006, in Blaser et al. 2011, p. 334); Between 1974 and 1997, the MBR lost Belize side of the border. Satellite often, such small-scale farmers 65 percent of its buffer zone, and areas imagery showed 113 ha (280 ac) in the ultimately sell the deforested land to near roads showed increasing CNP had been cleared as of 1987 by larger farmers and agro-industrial deforestation pressures in 1995–1997 Guatemalans for agricultural use, this owners (Blaser et al. 2011, p. 334). In (Hayes et al. 2002, p. 305; Bray et al. increased six-fold to 692 ha (1,710 ac) addition, the country has a high 2008, unpaginated). by 1994, and to approximately 3,126 ha dependence on wood as an energy

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source for poor households; thirty-eight and lead to uncontrollable wildfires that around the reserve, a result of the percent of the population uses firewood result in forest and other biodiversity continuous arrival of families from other for domestic purposes, which is degradation and loss (McGinley 2009, parts of the country into the region in considered a very high consumption p. 35). search of cheap land (Ravnborg 2010, rate (Government of Honduras 2009, The Nicaraguan Mosquitia (on the pp. 12–13; Ravnborg et al. 2006, pp. unpaginated). Caribbean slope), which is one area 4–5). Between 1998 and 2005, the The Mosquitia region has been where the scarlet macaw is known to population increased more than 100 characterized by relatively low occur in the country, is considered an percent in the municipality of El population density and inaccessibility, important area of extensive lowland Castillo, which is composed entirely of and its indigenous inhabitants have tropical forest that it is threatened by IMBR buffer zone and core area maintained the forest cover for rapid deforestation due to colonization (Ravnborg 2010, p. 10). The expansion centuries. However, the Honduran and the advancement of the agricultural of African palm plantations, pasture Mosquitia appears to be under frontier (Kaimowitz 2008, p. 487; lands, human settlements, and logging significant deforestation pressure and McGinley 2009, p. 31; Bray 2010, p. have contributed to an estimated 60 continues to suffer from colonization, 105). The bulk of Nicaragua’s forests on percent deforestation of the buffer zones agricultural expansion, and illegal the Caribbean slope are in indigenous surrounding IMBR and these activities logging, which has led to deforestation territories that hold rights to own their are expanding in the reserve (Fundacion and degradation in this region and parts own forests, but most lack formal titles del Rio and IUCN 2011, pp. 7–8; of the Rı´o Pla´tano Biosphere Reserve and tenure conflicts are widespread Ravnborg 2010, pp. 12–13; Nygren 2004, (Bray 2010, p. 102; Anderson and (Kaimowitz 2008, p. 487; McGinley pp. 193–194; Ravnborg et al. 2006, p. 2). Devenish 2009, pp. 256–257; Hayes 2009, p. 13). For example, Mosquitia Forest conservation efforts in the 2007, pp. 733–734). Recent information residents contend that public Nicaragua-Costa Rica border region have indicates that loss of habitat and management of protected areas fails to resulted in lower deforestation rates demand for the pet trade (see Factor B control agricultural expansion and within the San Juan-La Selva Biological discussion, below) are significant violates indigenous ancestral rights to Corridor, which includes the IMBR threats in this region (Portillo Reyes the land and its resources (Hayes 2007, along with other protected areas 2005, in Portillo Reyes et al. 2010, p. 6; p. 734). Illegal logging is a threat to (Chassot et al. 2010a, in Chassot and Brightsmith in litt. 2016, p. 8). forests in the Caribbean region and the Monge-Arias 2012, p. 67), although both Mosquitia (Bray 2010, p. 105). Illegal Nicaragua (A. m. cyanoptera) primary and regrowth forest within the logging in broadleaf forests was corridor and within the larger border In terms of total forest loss, Nicaragua estimated to be 30,000 to 50,000 m3/ region continue to decrease due to has lost more forest than all other year (1.1 to 1.8 million ft3/year), or timber extraction and agricultural Central American countries except approximately 50 percent of the total expansion (Fagan et al. 2013, Honduras. Nicaragua has lost production (Richards et al. 2003, p. unpaginated; Chassot and Monge-Arias approximately 1.4 million ha (3.5 284). However, with respect to the 2012, p. 63; Chassot and Monge-Arias million ac) of forest area over the past binational Mosquitia region, the 2011, p. 1; Chassot et al. 2009, p. 9). 25 years (FAO 2015, pp. 11, 41) (see pressures appear to be greater on the Thus, despite the existence of protected Tables 2a and 2b, below). Honduran side, although areas outside areas, deforestation continues to occur Much of the historic deforestation in the core of the Bosawas Biosphere and is a serious threat to biodiversity in Nicaragua was due to the expansion of Reserve area are also under pressure this region (Fundacion del Rio 2012a, cattle ranching and cotton farming until (Bray 2010, p. 106). The indigenous pp. 2–3; Fundacion del Rio 2012b, pp. both industries declined in the 1980s, occupied core zones of Bosawas are 2–3; Fundacion del Rio and IUCN 2011, resulting in abandonment of much showing virtually no deforestation, with pp. 34, 37, 73–74; Chassot et al. 2006, pasture land that left almost 1 million one such area having 97 percent forest p. 84). According to eBird (Sullivan et ha (2.5 million ac) in forest fallow (Bray cover in 2003 (Hayes 2007, p. 741). In al. 2009, unpaginated), many sightings 2010, p. 106). More recently, forest loss contrast, the Rı´o Pla´tano Biosphere of scarlet macaws exist in southeastern and degradation in Nicaragua was due Reserve on the Honduran side of the Nicaragua and northeastern Costa Rica to the expansion of agricultural and Mosquitia is under great deforestation since the issuance of our proposed rules grazing land, slash-and-burn pressures because of failed efforts to (77 FR 40222, July 6, 2012; 81 FR 20302, agricultural practices that create a centralize management in the April 7, 2016), indicating that the mosaic of forest and cultivated patches government, while protection is much species has continued to expand its across an increasing expanse of the more effective in the Bosawas core area range in this region. However, landscape (Global Witness 2007, in due to the decentralization of expansion of scarlet macaws in this McGinley 2009, p. 13). Illegal logging management in the hands of the region will likely be limited due to high and institutionalized forest sector indigenous inhabitants (Bray 2010, p. rates of deforestation (Brightsmith 2016, corruption have also led to forest loss 106). in litt., pp. 4–8). and degradation (Richards et al. 2003, Deforestation is ongoing in southeast p. 282). Deforestation and forest Nicaragua and resulted in forest cover Costa Rica (A. m. cyanoptera and A. m. degradation has also been attributed to loss from 2000–2017 (Hansen et al. macao Northern DPS) forest fires, pests (e.g., pine bark beetle 2013, entire). Southeast Nicaragua Costa Rica experienced some of the (Dendroctonus sp.)) and hurricanes, includes the Indio Maı´z Biological highest rates of deforestation in the though to a much lesser degree than to Reserve (IMBR) and its buffer zone. The world historically (Bray 2010, p. 107; anthropogenic factors (Rodrı´guez Quiros reserve is situated at the southeastern Government of Costa Rica 2010, p. 68), 2005, in McGinley 2009, p. 13). Farmers border of the country (Chassot and and as a result, the country’s forest often use fire to clear forest and Monge-Arias 2012, p. 63) and is one of cover declined from 67 percent in 1940, scrubland in preparation for crops, and Nicaragua’s best preserved forested to 17–20 percent in 1983 (Bray 2010, p. though these practices are typically areas (Ravnborg et al. 2006, p. 2). 107). Much of this deforestation was intended to be limited to a specific area, However, the reserve is threatened by driven by agriculture and cattle they can spread to adjacent vegetation the growing human population in or ranching; however, agriculture

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expansion was not as prevalent as National Park, the largest protected area Most of Panama’s scarlet macaw livestock expansion (Government of in ACOSA, is one of the protected areas population occurs on Isla Coiba, which Costa Rica 2010, p. 38). Cattle ranching in Costa Rica most affected by was used by the government of Panama underwent a serious contraction after deforestation close to its boundaries as a penal colony until 2004, thus 1989 (Arroyo-Mora et al. 2005, p. 28). In (Sanchez-Azofeifa et al. 2003, pp. 128– limiting human access and development 1993, only 20 percent of original scarlet 129). A comprehensive study of on the island (Government of Panama macaw habitat remained, all within deforestation in Costa Rica’s park 2005, p. 23; Steinitz et al. 2005, p. 26). protected areas (Marineros and Vaughan system found that deforestation inside Consequently, forests on the island 1995, pp. 445–446). However, during protected areas was negligible from remain largely intact. The Panamanian the 1990s, Costa Rica implemented 1987 to 1997, and that 1-km (0.62-mi) Tourism Authority has developed a several forest conservation strategies, buffer zones around the protected areas master plan for sustainable tourism for including new laws protecting forests had a net forest gain for the same Isla Coiba (2007–2020), which includes and mechanisms of payment for period. However, a 1 percent annual strategic guidelines for tourism ecosystem services (Bray 2010, pp. 107– deforestation rate was found in 10-km management. Further details on these 109; Kaimowitz 2008, pp. 488–491; (6.2-mi) buffer zones, suggesting guidelines are not provided, but the Pagiola 2008, entire; Sanchez-Azofeifa increased isolation of protected areas plan does not include infrastructure or et al. 2003, entire). (Sanchez-Azofeifa et al. 2003, pp. 128– high-impact development (UNESCO Costa Rica is the only country in 134). Additionally, in the ACOPAC 2011c, p. 60). Available information Mesoamerica to experience a positive population region, more deforestation is indicates that deforestation is not change in forest cover from 1990 to 2015 ongoing northwest of Carara than to the occurring on Isla Coiba (Brightsmith (FAO 2015, p. 10) (see Tables 2a and 2b, south (Brightsmith 2016, in litt., p. 12). 2016, in litt., p. 1; Hansen et al. 2013, below). Total forest cover in 2005 was The scarlet macaw occurs in entire), although some level of estimated to be 53 percent (Government northeastern Costa Rica, near Palo Verde degradation on the island may occur by of Costa Rica 2010, p. 68), more than and surrounding areas in northwest a herd of approximately 2,500 to 3,500 double the country’s forest cover in the Costa Rica, and in the two main feral cattle (UNESCO 2011c, pp. 23, 43; 1980s. Between 1990 and 2015, Costa populations of the ACOPAC and Suman et al. 2010, p. 25). However, the Rica gained 192,000 ha (474,442 ac) of ACOSA. Overall, Costa Rica is both extent of the cattle’s impact is unknown. total forest area, with an annual rate of losing and gaining forest cover The complete eradication of the cattle approximately 7,700 ha (19,000 ac or 0.3 throughout the country (Hansen et al. from Coiba National Park was classified percent) (FAO 2015, p. 10). as a priority issue (Suman et al. 2010, Even though Costa Rica has an 2013, entire; Brightsmith 2016, in litt. p. 1). However, the best available p. 25), but we are not aware of increase in total forest over the past 25 information indicating that the removal information indicates that the scarlet years (1990–2015), some level of of cattle has occurred. While cattle on macaw population in Costa Rica appears deforestation still occurs in parts of the Isla Coiba may be inhibiting the to be increasing, and Costa Rica is the country due to expansion of agriculture regrowth of former pasture to secondary only country in Central America to and livestock activities, and to illegal forest, they are probably not having a experience a positive change in forest logging in private forests, national significant impact on the larger forest cover over the past 25 years (1990– parks, and reserves (Government of trees on which scarlet macaws depend 2015). We conclude that deforestation or Costa Rica 2011, p. 2; Government of (Angehr 2012, in litt., unpaginated). Costa Rica 2010, pp. 10–11, 38, 52–54; forest degradation in the current range On the mainland of Panama, in the Parks in Peril 2008, unpaginated). Fifty of the scarlet macaw in Costa Rica is not area of the upper Rı´o Corotu´ near Puerto percent of forests in Costa Rica are occurring at a level that is causing a Armuelles and Quere´valo in the found in individual rural private further decline in the species; however, Chiriquı´ province where there have properties (Government of Costa Rica this area is not enough to sustain the been sporadic sightings of scarlet 2011, p. 1). The major driver of northern DPS of A. m. macao in the macaws, we are unaware of information deforestation on private lands is the future in given the threats occurring in indicating that deforestation and forest conversion of forest to livestock and the remainder of the range. degradation are impacting scarlet agricultural uses. In many cases, land Panama (A. m. macao Northern DPS) macaws. We are also unaware of users generate a higher annual income information indicating that with agriculture or livestock-raising Deforestation in Panama is relatively deforestation is occurring near the small than with forests. In protected areas, low for the Mesoamerica region; the (but unknown) number of scarlet underfunding and lack of human annual decrease from 1990–2015 was macaws on the southern end of the resources allows the penetration of 169 km2 (65 mi2 or 0.4 percent) (FAO Azuero Peninsula of Veraguas, near squatters and illegal loggers. 2015, p. 12) (see Tables 2a and 2b, Cerro Hoya National Park and in the Additionally, land tenure issues below). Drivers of deforestation include forest reserves just to the east. Less than contribute to forest loss because urbanization, cattle ranching, agro- 15 percent of the peninsula is covered indigenous communities have industrial development, unregulated by mature forest, but most of the difficulties keeping nonindigenous shifting cultivation, open mining, poor remaining forest can be found in Cerro farmers from encroaching onto their logging practices, charcoal-making, and Hoya National Park and the Tronosa lands (Government of Costa Rica 2011, fire (ITTO 2005, in Blaser et al. 2011, p. Forest Reserve to the east (Miller et al. p. 1) 354). Deforestation in the country 2015, p. 1). National Parks on the Caribbean slope currently occurs primarily in the Darien, We are aware of little information on are experiencing higher deforestation on Colon, Ngabe Bugle, and Bocas del Toro the magnitude and extent of surrounding lands than those on the provinces (Blaser et al. 2011, p. 354), deforestation and forest degradation on Pacific slopes, which is attributed to the which are outside the range in which Panama’s mainland and Isla Coiba, intensification and expansion of scarlet macaw currently occurs in although the most recent information agricultural cash crops such as banana Panama. Illegal logging is widespread in indicates that deforestation is not and pineapple (Sanchez-Azofeifa et al. the humid forests, even in protected occurring on Isla Coiba or any areas 2003, p. 129). However, Corcovado areas (Blaser et al. 2011, p. 361). where the scarlet macaw remains in

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very small populations on the mainland. concerns (i.e., cattle) on Isla Coiba Summary Tables The World Heritage Centre and IUCN remain poorly addressed (UNESCO concluded that the main conservation 2011c, p. 61).

TABLE 2a—TOTAL FOREST AREA IN MESOAMERICA 1990–2015

Forest area (1,000 ha) 1990 2000 2005 2010 2015

Belize ...... 1,616 1,459 1,417 1,391 1,366 Costa Rica...... 2,564 2,376 2,491 2,605 2,756 Guatemala ...... 4,748 4,208 3,938 3,722 3,540 Honduras ...... 8,136 6,392 5,792 5,192 4,592 Mexico ...... 69,760 67,856 67,083 66,498 66,040 Nicaragua ...... 4,514 3,814 3,464 3,114 3,114 Panama ...... 5,040 4,867 4,782 4,699 4,617

TABLE 2b—PERCENT CHANGE OF TOTAL FOREST AREA IN MESOAMERICA 1990–2015

Annual change rate

1990–2000 2000–2010 2010–2015 1990–2015 1,000 ha/yr % change 1,000 ha/yr % change 1,000 ha/yr % change 1,000 ha/yr % change

Belize ...... ¥15.7 ¥1.0 ¥6.8 ¥0.5 ¥5.0 ¥0.4 ¥10.0 ¥0.7 Costa Rica ...... ¥18.8 ¥0.8 22.9 0.9 30.2 1.1 7.7 0.3 Guatemala ...... ¥54.0 ¥1.2 ¥48.6 ¥1.2 ¥36.4 ¥1.0 ¥48.3 ¥1.2 Honduras ...... ¥174.4 ¥2.4 ¥120.0 ¥2.1 ¥120.0 ¥2.4 ¥141.8 ¥2.3 Mexico ...... ¥190.4 ¥0.3 ¥135.8 ¥0.2 ¥91.6 ¥0.1 ¥148.8 ¥0.2 Nicaragua ...... ¥70.0 ¥1.7 ¥70.0 ¥2.0 0.0 0.0 ¥56.0 ¥1.5 Panama ...... ¥17.3 ¥0.3 ¥16.8 ¥0.4 ¥16.4 ¥0.4 ¥16.9 ¥0.4

South America and Reserva Forestal de Montes de removing the trees that support the Maria (Montes Maria Forest Reserve) species’ nesting, roosting, and food Northwest Colombia (A. m. macao (7,460 ha (18,500 ac)) have lost 42, 71, requirements. Further, clearing or Northern DPS) and 70 percent of their forest, degradation of forests, including Colombia has lost approximately 5.9 respectively, since they were created in selective logging and the development million ha (14.6 million ac) of forest the late 1970s and early 1980s (Millet et of roads, provides additional over the past 25 years, with a steady rate al. 2004, p. 454). The Caribbean region opportunities for humans to expand into of change over that time frame (FAO of northwest Colombia showed the previously inaccessible areas, which in 2015, p. 10). In northwest Colombia, highest projected rate of change of forest turn creates easier access and forest loss is due primarily to cover by the year 2030 of all regions opportunity to exploit previously conversion of land to pasture and evaluated (Gonza´les et al. 2011, p. 45). undisturbed areas. Subsequent agriculture, but also mining, illicit Deforestation is ongoing in northwest encroachment is often followed by crops, and logging (Ortega and Lagos Colombia (Colombia Gold Letter 2012, additional deforestation as lands are 2011, pp. 85–86). Scarlet macaws in pp. 1–2; Ortega and Lagos 2011, pp. 81– cleared for cattle ranching and northwest Colombia are believed to be 82). Few large tracts of forest remain agriculture. Although scarlet macaws affected primarily by habitat loss, and to within the range of the scarlet macaw in are known to use partially cleared and a lesser extent trade (Donegan 2013, in this region, for instance, in the areas of cultivated landscapes, they are only able litt., unpaginated). Serrania de San Lucas and PNN to do so if the landscape maintains The Magdalena and Caribbean regions Paramillo, but these areas in northwest enough large, older trees that provide of northwest Colombia have Colombia are also deforestation hotspots the essential needs of the species. approximately 7 percent and 23 percent (Ortega and Lagos 2011, p. 82; Salaman Deforestation rates in Mesoamerica, (respectively) of their land area in et al. 2009, p. 21). excluding Costa Rica, are the highest in original vegetation, with the remainder Latin America due to expanding converted primarily to grazing land Summary of Factor A agriculture, cattle ranching, and (Etter et al. 2006, p. 376). The The destruction and modification of selective and often illegal logging. Magdalena region lost 40 percent of its the scarlet macaw’s habitat because of Destruction of forest habitat is one of the forest cover between 1970 and 1990, deforestation and forest degradation is a main causes of the decline of scarlet and an additional 15 percent between threat to the scarlet macaw throughout macaw subspecies Ara macao 1990 and 1996 (Restrepo and Syvitski parts of its current range, although the cyanoptera. Throughout the range of the 2006, pp. 69, 72). Within the Caribbean magnitude of this impact varies across northern subspecies (A. m. cyanoptera) region, Parque Nacional Natural (PNN) its range. Deforestation has fragmented where most of the species’ historical Paramillo (460,000 ha (1,136,680 ac)), habitat and continues to reduce and habitat has been eliminated, evidence Santuario de Fauna y Flora Los isolate areas that support populations of indicates that deforestation is ongoing. Colorados (Los Colorados Fauna and scarlet macaws. It directly eliminates We consider deforestation and forest Flora Sanctuary) (1,000 ha (2,500 ac)), the species’ tropical forest habitat by degradation to be an immediate threat to

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the subspecies because clearing of forest in the region. The Caribbean region of et al. 2000, p. 150; Wiedenfeld 1994, p. for agriculture, cattle ranching, and northwest Colombia showed the highest 102). Poaching of parrots from the wild illegal logging that leads to the loss of projected rate of change of forest cover is driven by demand from the pet scarlet macaw habitat are ongoing in of all regions evaluated. Forest loss in industry and rural poverty where wild Mexico in the Lacandon Forest and the region is due primarily to parrot populations exist. Capture for Chiapas, in the western Pete´n of conversion of land to pasture and sale in local markets can provide a Guatemala, and in the Chiquibul region agriculture, mining, illicit crops, and significant source of supplemental of Belize. The Honduran Mosquitia logging. The number of scarlet macaws income in rural areas (Huson 2010, p. appears to be under significant in northwest Colombia is unknown, but 58; Gonza´lez 2003, p. 438). Overall, deforestation pressure and continues to habitat loss has caused the decline of capture for the pet trade, along with suffer from rapid colonization, the species there, such that the species habitat loss as described above, are the agricultural expansion, and illegal has been all but extirpated from large main factors impacting the existence of logging. Nicaragua lost more forest than areas in the region. However, the region scarlet macaws in the wild (In˜ igo-Elias all other Central American countries is reported to have large tracts of in litt. 1997, in Snyder et al. 2000, p. except Honduras. With respect to the suitable forest habitat. 150; Guedes 2004, p. 280). binational Mosquitia region, pressure The scarlet macaw subspecies (Ara Because the scarlet macaw is a long- appears to be greater on the Honduran macao cyanoptera and A. m. macao) in lived species with a low reproductive side, but Nicaragua suffers rapid Mesoamerica are significantly impacted rate, low survival of chicks and deforestation due to colonization and by deforestation in many countries in fledglings, late age to first reproduction, illegal logging. The border region (Rı´o this region, which comprises less than and large proportions of nonbreeding San Juan (San Juan River) of 17 percent of the species’ range. Because adults, this species is particularly southeastern Nicaragua and deforestation is ongoing and the vulnerable to overexploitation from northeastern Costa Rica has sections of populations of the scarlet macaw harvesting (Munn 1992, p. 57; Wright et contiguous forests; however, subspecies A. m. cyanoptera are small, al. 2001, p. 712). Capture of parrots deforestation continues to occur and is we consider habitat destruction and decreases the population, inhibits future a serious threat to biodiversity in this modification to be a substantial threat to breeding by removing reproductive age area. the northern subspecies A. m. adults, causes mortality of eggs or Throughout the range of the northern cyanoptera throughout its range in chicks, causes the loss of or damage to DPS of the southern subspecies (Ara Mexico, Guatemala, Belize, Honduras, nesting sites, and can stop population macao macao) evidence indicates that Nicaragua, and Costa Rica (Atlantic growth and cause local extirpations if Costa Rica is both losing and gaining slope). But even though deforestation individuals are removed year after year forest cover throughout the country. continues in parts of Costa Rica, we do (Cantu-Guzman et al. 2007, p. 14). Costa Rica experienced some of the not find that it is occurring at a level When chicks are targeted, the effects on highest rates of deforestation in the that is an immediate threat to A. m. the population may be difficult to detect world historically. More recently, Costa macao on the Pacific Coast of Costa because scarlet macaws are long-lived Rica has an increase in total forest over Rica, especially because the data and it would take time to show a the 25-year period from 1990–2015 and indicate that the species is likely decline (Wright 2001, p. 717). When is the only country in Central America increasing within the two main adults are targeted, the population is to experience a positive change in forest populations on the Pacific Coast. depleted more rapidly because cover. But some level of deforestation Similarly, the data indicate that reproductive individuals are removed still occurs in parts of the country due deforestation is not impacting the from the population and the impact is to expansion of agriculture and scarlet macaw in Panama where it immediate (Collar et al. 1992, p. 6). livestock activities, and illegal logging currently occurs. Therefore, we do not Legal International Trade in private forests and in national parks consider deforestation to be as and reserves. The available information significant of a stressor to A. m. macao The United States and Europe were indicates that the scarlet macaw in Costa Rica and Panama. However, in historically the main markets for wild population in Costa Rica appears to be Colombia, habitat loss has caused the birds in international trade (FAO 2011b, increasing, and we are unaware of any decline of the species from large areas p. 3). Trade in parrots was particularly information indicating that in the region, and many of the areas in high in the 1980s, due to a huge demand deforestation or forest degradation in northwest Colombia are deforestation from developed countries (Rosales et al. the current range of the scarlet macaw hotspots, even though the region is 2007, pp. 85, 94; Best et al. 1995, p. in Costa Rica is occurring at a level that reported to have large tracts of suitable 234). However, in the years following is causing or likely to cause a further forest habitat. the enactment of the WBCA in 1992 (16 decline in the species. U.S.C. 4901 et seq.), poaching levels In Panama, we are aware of little Factor B: Overutilization for were lower than in prior years, information on the magnitude and Commercial, Recreational, Scientific, or suggesting that import bans in extent of deforestation and forest Educational Purposes developed countries reduced poaching degradation on the mainland, although Parrots and macaws have been levels in exporting countries (Wright et the scarlet macaw was described as captured and traded for centuries in the al. 2001, pp. 715, 718). A massive almost extinct from mainland Panama. Neotropics (Cantu-Guzman et al. 2007, reduction occurred in the number of Currently, deforestation is concentrated p. 9; Guedes 2004, p. 279; Snyder et al. wild-caught parrots imported to the in provinces outside the range of where 2000, pp. 98–99). Because they are United States, both from Central and scarlet macaws occur in Panama. On colorful, adapt to captivity, and can South America and the rest of the Isla Coiba, where most of the population imitate language, they are captured for world, following the enactment of the in Panama occurs, evidence indicates their feathers and used as pets (Guedes WBCA (Pain et al. 2006, p. 327). The large-scale deforestation is not a threat 2004, p. 279). The scarlet macaw is a European Union, which was the largest to the species. popular pet species within its range market for wild birds following Much of northwest Colombia has been countries, and the majority of birds sold enactment of the WBCA, banned the deforested and it is expected to continue as pets remain within country (Snyder import of wild birds in 2006 due to

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disease concerns (FAO 2011b, p. 21), income, and as a result, scarlet macaws McNab 2008, p. vi; Garcia et al. 2008, thus eliminating another market for are still captured throughout the region p. 51). wild birds and further reducing and traded illegally (TRAFFIC NA 2009, In the Chiquibul Forest in Belize, international trade. pp. 23–24). Due to the high mortality poaching is a threat to scarlet macaws, The scarlet macaw was initially listed rate associated with capture and but the situation has improved in recent in Appendix II of CITES (June 6, 1981), transport, the number of birds actually years. In 2011, the poaching rate was 89 but effective January 8, 1985, was sold or exported for the pet trade percent (Breaking Belize News 2017, included in Appendix I. Species represents only a portion of those unpaginated). Nests were being poached included in Appendix I are considered removed from the wild. Cumulative by guaceros and xateros, which are threatened with extinction, and mortality rates before parrots reach Guatemalans who illegally cross the international trade is permitted only customers have been estimated to be as border into Belize for economic reasons. under exceptional circumstances, which high as 77 percent; for nestlings, Thus, with this high percentage of generally precludes commercial trade. approximately 80 percent died before poached chicks, scarlet macaws Of the total live specimens reported in reaching a pet store (Inigo and Ramos essentially had no productivity trade between 1985 and 2016, 1991 and Enkerlin 2000, in Cantu- (Harbison 2017, unpaginated). Of the approximately 95 percent of the total Guzman et al. 2007, p. 60). nests monitored in 2013, approximately live, wild-sourced scarlet macaws that 30 percent of the failed nests were were in trade during 1985 to 2016 were Mexico, Guatemala, and Belize (A. m. attributed to poaching; these nests exported from Suriname, which is one cyanoptera) contained 33 percent of the total of only two countries in South America Poaching has occurred at significant hatchlings (The Guardian Belize 2014, that still legally export significant levels in the Maya Forest region of unpaginated). Incidences of poaching quantities of wildlife (Duplaix 2001, p. Mexico, Guatemala, and Belize, and is were reduced to an average of 35 ii) and the only scarlet macaw range one of the most important factors percent between 2012 and 2015 country that entered a reservation to the influencing population growth of the (Breaking Belize News 2017, Appendix I listing of the species. A scarlet macaw in this region, indicating unpaginated). Over the past 5 years, the reservation means that these countries that even relatively low levels of Scarlet Six team (see Conservation are treated as a country not party to poaching could result in population Measures, below) has reduced overall CITES with respect to the species declines (Clum 2008, pp. 76–80). nest poaching from higher than 90 concerned. However, if a country with Poaching is a persistent problem and percent to less than 30 percent, and a reservation to a listing in the CITES the second largest threat to scarlet 2017 is the second year in a row that no Appendices wishes to trade that species macaws in Mexico after deforestation, known nests were poached (Harbison with a country that has not taken the although information on the extent of 2017, unpaginated). same reservation, then that trade must poaching in Mexico is largely Honduras and Nicaragua (A. m. follow the CITES permit requirements unavailable (Inigo-Elias 1996, p. 62; cyanoptera) (CITES 2018, unpaginated). Wildlife Boyd and McNab 2008, p. xiii). In many exports generate significant income and instances, poachers damage trees to Poaching of the scarlet macaw occurs jobs in Suriname, and the country has reach the birds. During the 1993 in both Honduras and Nicaragua, set an annual voluntary export quota of breeding season, four nest trees from a although little quantitative information 100 live specimens per year since 1998. total of 41 were cut down and another is available (TRAFFIC NA 2009, p. 5). The quota includes a notation that was burned (Inigo-Elias 1996, p. 62). In Honduras, the scarlet macaw Parties may not authorize import for Detained traffickers reported that parrot population has decreased and is primarily commercial purposes (CITES populations in Chiapas (the primary experiencing severe reproductive limits 2018, unpaginated). Suriname’s wildlife state in which the species occurs in due to poaching (Lafeber Conservation export quotas are reported to be Mexico) have decreased so much that and Wildlife 2011, unpaginated). Nest ‘‘realistic’’ in that they are based on the trapping is now conducted in protected monitoring indicated 5 of 6 nests active belief that larger parrots cannot sustain areas in Chiapas (Cantu-Guzman et al. in February 2003 were poached by large harvests (Duplaix 2001, pp. 10, 65, 2007, p. 14). Fewer than 50 scarlet August (McReynolds 2016, in litt., 68). Actual exports of CITES listed macaws are captured annually in unpaginated). In 2003, an estimated 200 species are often lower than Suriname’s Mexico (Cantu-Guzman et al. 2007, p. to 300 chicks were poached just in the allowed quotas (FAO 2010b, p. 42; 35). Rus Rus area of the Honduran Mosquitia Duplaix 2001, p. 10). However, in a Much of the scarlet macaw population (Portillo Reyes et al. 2004, in number of recent years, Suriname has in Guatemala is currently protected McReynolds 2011, in litt., unpaginated). also reported exports in excess of its through conservation efforts. Prior to the In a 2010–2011 survey of 20 nests quota of 100 live specimens. Wildlife Conservation Society (WCS) previously used by parrots, 16 of which monitoring nests in 2002, poaching was were scarlet macaws, 17 showed Poaching Within Mesoamerica a serious concern. Between 1992 and evidence of poaching including all the The scarlet macaw is protected by 2002, citing Proyecto Guacamaya of scarlet macaw nests (Lafeber domestic laws within all countries in ProPeten data, 115 chicks were poached Conservation and Wildlife 2011, Mesoamerica (see Factor D discussion, from the Laguna del Tigre area (Moya unpaginated). below). However, enforcement of and Castillo Villeda 2002, in In Nicaragua, capture of parrots for wildlife laws in these countries is McReynolds 2016, in litt., unpaginated). the pet trade is described as common generally lacking because they often do However, since 2003, the severity of (Herrera 2004, p. 1). Scarlet macaws are not have the resources, personnel, or poaching has greatly decreased because one of the three most preferred species both to adequately enforce their laws of WCS’s conservation efforts (Garcia et in Nicaragua’s parrot trade and are (TRAFFIC NA 2009, p. 20; Valdez et al. al. 2008, p. 51). Although in areas where among the main CITES-species 2006, p. 276; Mauri 2002, entire). the WCS is not working and protection harvested for illegal trade in the country Additionally, low salaries and high is lacking, which is up to 25 percent of (McGinley et al. 2009, p. 16; Lezama unemployment in the region drives the population in Guatemala, it is likely 2008, abstract; Nicaragua Ministerio del people to search for extra sources of that these nests are poached (Boyd and Ambiente y Los Recursos Naturales

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(MARENA) 2008, p. 25). Based on residents interviewed believed that Isla Coiba National Park, poaching is not interviews with locals, Nicaraguan scarlet macaws were still being poached a known problem on the island poachers bring chicks into Honduras in the ACOSA, although 85 percent of (McReynolds 2016, in litt. unpaginated). from Nicaragua, where they more easily the interviewees believed numbers of The island has no permanent enter into trade (Portillo-Reyes et al. scarlet macaws were increasing (Dear et habitations except a police base and the 2004, in McReynolds 2016, in litt., al. 2010, pp. 10–13). Forty-three percent ranger base; the island has no roads and unpaginated). Confiscations and of the interviewees mentioned that less very few maintained trails, which are all prosecutions by government authorities poaching occurs now than before, and short; and access is by boats that are occurred in 2009 in the Caribbean none said the activity had increased boarded and checked regularly region of the county and in 2010 in (Dear et al. 2010, p. 13). Therefore, it is (McReynolds 2016, in litt. p. 8). Managua where a dozen scarlet macaws believed that poaching is ongoing but Summary of Factor B were for sale (McReynolds 2016, in litt., has decreased and the ACOSA unpaginated). Parrot populations in population is increasing (Dear et al. Parrots and macaws have been Nicaragua have declined by as much as 2010, p. 19). Based on interviews, it was captured and traded for centuries in the 60 percent since the mid-1990s, estimated that 25 to 50 chicks are Neotropics. Despite regulation of although the loss of habitat has also poached each year (Dear et al. 2005, p. international scarlet macaw trade contributed to the decline (MARENA 19). In 2006, 11 of 57 (19 percent) through CITES, the WBCA, and similar 2008, p. 51). Additionally, the small potential nest cavities found in ACOSA stricter measures by the European population in the Cosigu¨ ina Nature were reported by local residents as Union, some level of international trade Reserve on the Pacific Coast suffers from recently poached, but the actual number occurs with wild scarlet macaws. poaching of both chicks and adults of poached nests is likely greater However, most scarlet macaws reported (Boyd and McNab 2008, p. x). (Guittar et al. 2009, pp. 390, 392). in trade are from non-wild sources; were captive-bred; or were parts, feathers, or Costa Rica (A. m. cyanoptera and A. m. Panama (A. m. macao) scientific specimens rather than live macao) Little information is available on birds. Of the wild-sourced, live birds, Historically, scarlet macaws in Costa capture of scarlet macaws in Panama, the vast majority were exported from Rica experienced heavy poaching although it was a factor leading to the Suriname, which is reported to set pressure. Of 56 known nest cavities in virtual extirpation of this species from realistic quotas. Therefore, international the ACOPAC studied from 1992 to 2000, the country (McReynolds 2016, in litt. trade of scarlet macaws is not a current 64 percent were considered at high risk unpaginated). Trade in rare and threat to the species. and 23 percent were at medium risk endangered species is a constant threat The scarlet macaw is a popular pet (Vaughan et al. 2003, p. 8; McReynolds in the country due to the high prices species within its range countries and 2016, in litt., unpaginated). In studies paid for these animals and their parts overutilization as a result of poaching conducted in the 1990s in Carara (Parker et al. 2004, p. II–6; Keller and for the pet trade is a significant threat National Park, which is the traditional Schmitt 2008, abstract). Additionally, to the scarlet macaw in some areas of its stronghold of the ACOPAC population poaching is a common occurrence in current range. The scarlet macaw is of scarlet macaws, 56 to 64 percent of rural areas because wild game is a susceptible to overharvest because it is evaluated nest sites showed signs of traditional source of protein for a long-lived species with a low being poached with some nests poached residents (Parker et al. 2004, p. II–6). reproductive rate and it is slow to yearly (Vaughan et al. 2003, pp. 6, 8; Cerro Hoya National Park is located recover from harvesting pressures; thus, Snyder et al. 2000, p. 150; Marineros within Panama’s most impoverished removal of individuals year after year and Vaughan 1995, p. 460). However, province, and thus the capture of scarlet can stop population growth and cause anti-poaching efforts in ACOPAC during macaws is a potential threat because local extirpation. Most harvested birds 1995–1996 may have increased campesinos (a Latin American Indian likely remain within the species’ range recruitment into the population farmer or farm laborer) invade countries. (Vaughan et al. 2005, p. 127). From 2004 unoccupied lands and poaching for The subspecies Ara macao to 2009, most of the poached animals sustenance and monetary gain is cyanoptera occurs mainly in small were paca (Cuniculus paca), but scarlet common (Government of Panama 2005, populations; thus, poaching wild birds macaws were also poached and were p. 36). Moreover, despite a program to for the pet trade is detrimental to among the top four species identified by use captive scarlet macaw feathers to sustaining these populations. Evidence park officials as most at risk of cut down on hunting of wild birds for suggests poaching occurs at significant poaching, local extinction, or both their feathers, hunting still occurs and levels in the Maya Forest region, where (Huson 2010, pp. 19–20). Hunting is poaching of chicks for pets remains a even moderate levels of poaching could important in the communities for both problem at Cerro Hoya National Park cause a decline in these already small subsistence and monetary gain; with (Rodriquez and Hinojosa 2010, in populations. Many of the scarlet low-income communities surrounding McReynolds 2016, in litt., unpaginated). macaws nesting sites in Guatemala are the park, the incentives to poach are While scarlet macaws may currently protected through great (Huson 2010, p. 66). A significant occasionally be illegally captured on conservation efforts compared to nesting effort to control poaching in the Carara Isla Coiba, we are not aware of any sites in Mexico; therefore, success rates area is ongoing because poaching information that poaching is currently a in Mexico are almost certainly lower continues to be a serious problem threat to the species on the island. The than in Guatemala, even though about (Vaughan 2005, pers. comm., in scarlet macaw primarily occurs on the 25 percent of Guatemala’s population is McReynolds 2016, in litt., unpaginated). south end where poaching is a unprotected. In Belize, nest poaching However, the ACOPAC population of possibility. However, based on has been dramatically reduced over the scarlet macaws was believed to be self- interviews with the owner of Bird Coiba past 5 years but continues. Although sustaining, even with heavy poaching (the bird guide service for the island), quantitative data from Honduras and pressure (Vaughan et al. 2005, p. 128). two rangers with many years of Nicaragua are lacking, poaching is In 2005, in the ACOSA, experience on the island, and a recognized as a significant threat to the approximately half (48 percent) of discussion with the superintendent of scarlet macaws in these countries.

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The subspecies Ara macao macao in laws supporting national forest policy in scarlet macaw in Costa Rica is occurring Costa Rica and Panama has experienced Colombia are incorporated within other at a level that is causing a decline in the heavy poaching pressure historically. laws (FAO 2010a, pp. 302–303). All species. Forest area has increased over Efforts to control poaching are ongoing range countries except Belize also have 25 years and the range of scarlet macaws in Costa Rica, but it continues to be a National Forest programs that provide on the Pacific slope of Costa Rica has substantial problem. Little information the framework to develop and increased. In Panama, although large- is available regarding poaching of implement their forest policies, scale deforestation is not occurring scarlet macaws in Panama. It is one although the status of Panama’s program where the small populations of scarlet factor that led to the near extirpation of is unknown (for information on macaws are currently known to exist, this species from mainland Panama and regulatory mechanisms pertaining to small-scale logging continues with little remains a concern at Cerro Hoya forest management in scarlet macaw oversight and significantly contributes National Park. Poaching is not a threat range countries see: Pen˜ a-Claros et al. to ongoing forest degradation. In on Isla Coiba. 2011, entire; Espinosa et al. 2011, pp. northwest Colombia, even though the The scarlet macaw in Mesoamerica 21–26; FAO 2011c, p. 78; Government region is reported to have large tracts of consists mostly of small populations, of Colombia 2011, pp. 89–91, 203–211; suitable forest, many of the areas in and it is reasonable to conclude that any Guignier 2011, pp. 12–22; Larson and northwest Colombia are deforestation level of poaching poses a significant Petkova 2011, entire; May et al. 2011, hotspots. Habitat loss has caused the threat to the species in this portion of pp. 16–55; Stern and Kernan 2011, pp. decline of the species from large areas its range, especially considering the 52–54, 88– 90; United Nations in the region, and existing regulations susceptibility of scarlet macaws because Collaborative Programme on Reducing have not been sufficient to reverse the of its reproductive traits. The available Emissions from Deforestation and Forest transformation of natural ecosystems. information indicates that poaching of Degradation in Developing Countries Major forest reserves have been Ara macao cyanoptera chicks and (UN–REDD) 2011, unpaginated; Belize degraded from their original condition. adults is a significant stressor Ministry of Natural Resources and Therefore, the existing regulatory throughout its range. Populations of A. Development 2010, pp. 54, 57–58; mechanisms addressing this threat in m. macao in Costa Rica on the Pacific Blaser et al. 2010, pp. 263– 267, 277– Panama and Colombia are not adequate slope are likely increasing even with 281, 291–293, 300–302, 311– 312, 320– to protect forested land that the species poaching pressure, indicating that 323, 334–337, 345–346, 365– 367, 376– depends on. 377, 394–396; CIFOR 2010, p. 45; FAO poaching may not be a major threat in Illegal Capture and Trade Costa Rica. However, poaching 2010a, pp. 150–158, 302–303; continues and remains a concern. Little Government of Belize 2010, pp. 27–34; The scarlet macaw is protected under information exists regarding poaching of Sparovek 2010, pp. 6046–6047; Tolisano CITES, an international agreement among governments to ensure that the scarlet macaws in Panama, but because and Lopez-Selva 2010, pp. 24–28; Bauch international trade of CITES-listed plant poaching was one of the reasons for the et al. 2009, entire; McGinley et al. 2009, and animal species does not threaten species’ almost extirpation on the pp. 18–30; Patriota 2009, pp. 612–615; species’ survival in the wild. Under this mainland and the remaining Trevin and Nasi 2009, entire; Byers and treaty, CITES Parties (member countries populations are very small and Israel 2008, pp. 29–34; Torres-Lezama et or signatories) regulate the import, susceptible to poaching, we consider al. 2008, entire; Hopkins 2007, pp. 398– export, and re-export of specimens, poaching to be a stressor to scarlet 405; Playfair 2007, entire; Portilla and parts, and products of CITES-listed macaws on mainland Panama. We are Eguren 2007, pp. 19–32; World Bank plant and animal species. Trade under not aware of information regarding the 2007, pp. 10–28, 71–76; Clark 2006, pp. 19–29; Grenand et al. 2006, pp. 49, 54– CITES is authorized through a system of level of poaching in northwest permits and certificates that are issued Colombia. 56; Baal 2005, unpaginated; Parker et al. 2004, pp. III–1–III–8, Annex H, Annex by the designated CITES Management Factor C. Disease or Predation I; Government of Belize 2003, entire; Authority of each CITES Party (CITES 2018, unpaginated). All the countries In our proposed rule (77 FR 40237– Bevilacqua et al. 2002, pp. 6–9; Mauri within the range of the scarlet macaw 40238; July 6, 2012), we concluded that 2002, entire; Vreugdenhil et al. 2002, are Parties to CITES. However, when the disease and predation are not threats to pp. 6–10). species was included in Appendix I in the northern subspecies of scarlet Habitat destruction or modification 1985, Suriname (along with three macaw or the northern DPS of the from deforestation and forest European countries: Austria, southern subspecies. We received no degradation occurs in most portions of Switzerland, and Liechtenstein) entered additional information indicating the range of the A. m. cyanoptera. a reservation to the listing (Austria otherwise. Many, if not all, of these countries have regulations aimed at conserving forested withdrew its reservation in 1989) Factor D: Inadequacy of Existing area, but for the most part they are not (UNEP–WCMC 2012, unpaginated). A Regulatory Mechanisms able to adequately enforce their reservation means that a country is regulations due to lack of financial, treated as not a party to CITES with Forest Conservation Regulations personnel, and technical resources; respect to the species concerned. With the exception of Belize, all conflicts over land ownership, which However, if a country with a reservation countries in the range of A. m. can lead to illegal logging and to a listing in the CITES Appendices cyanoptera and the northern DPS of A. expansion of agriculture and pasture; wishes to trade that species with a m. macao have a national or subnational and lack of oversight or coordination country that has not taken the same policy framework on forests and their with a governing body. reservation, then that trade is subject to management, although Belize has a In the northern DPS of the southern the CITES permit requirements since the variety of regulations that protect their subspecies A. m. macao, Costa Rica is non-reserving Party is bound by the natural resources. Of those countries both losing and gaining forested land, CITES requirements (CITES 2018, with a policy framework, all but but we are unaware of any information unpaginated). Colombia have specific national forest indicating that deforestation or forest The import of scarlet macaws into the laws in support of these policies, but degradation in the current range of the United States is also regulated by the

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WBCA, which was enacted on October Mexico (A. m. cyanoptera) National and municipal agencies 23, 1992. The purpose of the WBCA is The General Law of Wildlife for generally have insufficient human to promote the conservation of exotic Mexico establishes that no bird resources, have insufficient training, birds by ensuring that all imports of specimen corresponding to the family and lack the necessary equipment to exotic birds to the United States are Psittacidae or psittacid (including Ara effectively monitor or mitigate hunting biologically sustainable and not macao cyanoptera), whose natural impacts, and much of the monitoring detrimental to the species in the wild. distribution is within the national that does occur is done on a relatively The WBCA restricts the import of most territory, may be subject to extractive haphazard basis by different research CITES-listed live or dead exotic birds. exploitation for subsistence or institutions and nongovernmental organizations (Tolisano and Lopez-Selva Import of dead specimens is allowed for commercial purposes, especially species 2010, p. 44). scientific purposes and museum that are endemic, threatened, A similar situation to unregulated specimens. Permits may be issued to endangered, or protected by allow import of listed birds for various hunting exists for the capture and sale international treaties (Official Mexican of live animals to supply the pet trade, purposes, such as scientific research, Standard NOM–059–SEMARNAT–1994; zoological breeding or display, or research institutions, and zoological Animal Legal and Historical Center collections. Scarlet macaws are personal pets, when certain criteria are 2018, unpaginated; Cantu-Guzman met. The Service may also approve overexploited; nestlings are taken from 2007, p. 45). Mexico considers the their tree cavity nests prior to fledging cooperative breeding programs and scarlet macaw to be in danger of subsequently issue import permits to and sold on the local market in the extinction within the country Pete´n (Tolisano and Lopez-Selva 2010, allow the import of birds for use in such (Government of Mexico 2010a, p. 32). p. 44). Guatemalan authorities do a programs. The United States may also The Secretariat may only grant relatively good job of trying to control approve foreign sustainable use authorizations for extractive use for this traffic, but rumors that scarlet management plants under the WBCA. conservation or scientific research macaw chicks can fetch $300–$600 USD At this time, the scarlet macaw is not purposes. Responsibility for on the black market continue to fuel part of a Service-approved cooperative implementation lies with Profepa, the illegal trade within the country (Muccio breeding program, and very few wild- agency of the Environment Ministry in 2009, p. 14). caught birds have been recorded for charge of policing environmental laws importation. (Cantu-Guzman et al. 2007, p. 45). The Belize (A. m. cyanoptera) The Lacey Act (18 U.S.C. 42; 16 most serious difficulty Profepa faces in Belize’s Wildlife Protection Act U.S.C. 3371–3378) was originally passed the combat against illegal bird trade is provides for the regulation of hunting in 1900, and was the first Federal law the limited number of inspectors it has and the commercial dealing in wildlife. protecting wildlife. Today, it provides for the whole country (Profepa 2002, in It prohibits hunting of specific species, civil and criminal penalties for the Cantu-Guzman et al. 2007, p. 45). in closed areas, and of immature illegal trade of animals and plants. Seizures by Profepa was estimated at wildlife or females accompanied by Under the Lacey Act, in part, it is approximately 2 percent of the annual their young. It is administered by the unlawful to import, export, transport, illegal trade, which represents a very Forest Department of the Ministry of sell, receive, acquire, or purchase any small portion of the number of parrots Natural Resources and the Environment fish or wildlife taken, possessed, captured each year (Cantu-Guzman et (Government of Belize 2010, p. 29). This transported, or sold: (1) In violation of al. 2007, p. 49). Of the 65,000 parrots law prohibits hunting of the scarlet any law, treaty, or regulation of the that were captured annually, data macaw and prohibits hunting wildlife in United States or in violation of any indicate as few as up to 50 scarlet a forest reserve without a license Indian tribal law; or (2) in interstate or macaws (or less than 0.1 percent of the (Wildlife Protection Act 2000, entire). foreign commerce, any fish or wildlife total parrots) were captured annually in Scarlet macaws have been poached by taken, possessed, transported, or sold in Mexico, even though some of these may Guatemalans (guaceros and xateros) that violation of any law or regulation of any be from Central American countries illicitly cross the border into Belize for State or in violation of any foreign law. (Cantu-Guzman et al. 2007, p. 35). From economic reasons. Most poaching is The Lacey Act covers all fish and 1995 to 2005, 144 scarlet macaws were opportunistic. Past incidences of wildlife and their parts or products, seized by Profepa (Cantu-Guzman et al. conflict between law enforcement and plants protected by CITES. 2007, p. 52). Guatemalan nationals have occurred (Harbison 2017, unpaginated). The Although illegal trapping for the pet Guatemala (A. m. cyanoptera) Belize Defense Force cooperates with trade occurred at high levels during the National hunting legislation was first the Scarlet Six team to deter poaching 1980s, international trade has decreased passed in Guatemala in 1970, with the scarlet macaw chicks (see Conservation significantly as a result of tighter mandates of this national policy Measures, below). enforcement of CITES regulations, reinforced in the legislation passed on adoption of the WBCA, and similar protected areas in 1989. Hunting is Honduras (A. m. cyanoptera) stricter measures under European Union widely used by most rural residents in Three institutions are charged with legislation, along with adoption of Guatemala to supplement food and biodiversity conservation in Honduras: national legislation in range countries income needs, and is largely The Secretariat of Natural Resources (Snyder et al. 2000, p. 99). Based on the unregulated and inconsistently and Environment (SERNA); the best available data, we found no monitored (Tolisano and Lopez-Selva Secretariat of Agriculture and Cattle information indicating international 2010, p. 44). Ranching (SAG); and the ICF who trade is currently a threat to the scarlet Most of the data on hunting has not develops programs, regulations, or macaw populations. been published or systematically projects for biodiversity conservation The laws and regulations that govern organized to indicate the magnitude or with an emphasis on species in danger capture and trade of scarlet macaw in intensity of local and national hunting of extinction (Hansen and Florez 2008, the range countries are briefly discussed pressures (CECON–PROBIOMA 2005, in p. 17). Internal legislation concerning below. Tolisano and Lopez-Selva 2010, p. 44). biodiversity centered on a 1990

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government decree prohibiting the Costa Rica (A. m. cyanoptera and A. m. rare species (Parker et al. 2004, p. III– capture and sale of wildlife within macao) 2; Blaser et al. 2011, p. 355). The Panamanian national police force Honduras. However, it has been Costa Rica’s Wildlife Conservation is responsible for preventing all criticized for contributing to illegal Law and its amendments prohibit the infractions of the law, such as hunting trafficking of wildlife through hunting, collection, and extraction of violations (Parker et al. 2004, p. III–8). neighboring countries, particularly species, except in certain cases for ANAM counts on police support, which through the sparsely populated border subsistence by indigenous groups, is often more concerned about major with Nicaragua (Anderson and Devenish scientific purposes, or species control crime, and routinely treats 2009, p. 257). A National Biodiversity (Costa Rican Embassy 2013, environmental infractions as minor Strategy was published in 2000 unpaginated; NOVA 2013, unpaginated; (Anderson and Devenish 2009, p. 257). nuisances. Local corregidores (i.e., local Tico Times 2017, unpaginated). administrative officials) often have little However, no specific legislation to The Biodiversity Law has the knowledge of environmental laws and manage biodiversity exists (World Bank objective of conserving biodiversity and little impact on their enforcement, but 2007, p. 12).Wildlife is sold openly in the sustainable use of the resources, as the streets, and families maintain scarlet these local officials are important links well as to distribute in an equitable in the enforcement of environmental macaws as pets (Hansen and Florez manner the benefits and derived costs. 2008, p. 22). Also, despite the Rı´o laws, and have influence on resident’s The law includes the obligation of the behavior (Parker et al. 2004, p. V–10). Pla´tano Biosphere Reserve’s status, state to avoid and prevent damage or poaching occurs within its boundaries. Training officials adjacent to or within destruction, present or future, to human, protected areas results in less illegal Nicaragua (A. m. cyanoptera) animal, or plant health, or to the hunting and harvesting in protected integrity of the ecosystems, and to avoid areas (Parker et al. 2004, pp. III–2, V– Historically, wildlife in Nicaragua has any risk or danger which threatens the been used as food for poor rural and 10). Nonetheless, sport and commercial permanence of ecosystems (Hopkins hunting without regulation and indigenous populations, for sport 2007, p. 404). hunting, for medicinal and cultural use, subsistence hunting in the country Costa Rica has protected its resources continue. and as pets (MARENA 2008, p. 22). through an ambitious national parks and Illegal capture and trade of wildlife biological reserves system, but they are Colombia (A. m. macao Northern DPS) species is also a source of income inadequately funded and insufficiently Under Colombian wildlife legislation, (McGinley et al. 2009, p. 16). Despite controlled (Government of Costa Rica all wildlife belongs to the State; the scarcity of records, laws to regulate 2010, p. 34). Poaching by local although local communities (e.g., wildlife trade in Nicaragua have existed communities is a problem of great mayors, regional autonomous since the late 19th century. concern; hunting within national park corporations, indigenous reserves) have MARENA is a key agency responsible boundaries is illegal, but such activities the right to participate in decisions for conservation of endangered species are difficult to monitor and enforce with regarding resources under their in Nicaragua. In 2008, 123 species were limited funds and supervision (Huson jurisdictions and to enjoy a healthy permanently banned from harvest or 2010, p. 18; Government of Costa Rica environment (International Institute for use, and another 61 species were 2010, p. 52). This limitation is reported Environment and Development 2018, partially banned; many of these banned in Carara National Park, in which park unpaginated; Blaser et al. 2011, p. 297). species are also listed by the IUCN or by officials believe that they do not have Wildlife legislation stipulates a general CITES. Hunting of the scarlet macaw is enough enforcement staff to effectively ban on hunting, but subsistence hunting prohibited (Nicaraguan laws 559 and control poaching (Huson 2010, p. 8). and fishing are allowed provided no ban 641; FAOLEX 2018, unpaginated). Panama (A. m. macao) is in place for a particular species. In Nonetheless, these national species 1994, illegal hunting was established as protection bans are rarely applied and To protect and regulate the use of a crime in the penal code, which enforced (McGinley et al. 2009, p. 22). wildlife, flora and fauna, the includes penalties for poaching and The scarlet macaw is a principal species Panamanian government has created illicit use of renewable natural resources involved in illegal trade (McGinley et al. numerous laws. The initial legislation (Gomez et al. 2015, unpaginated). Trade 2009 p. 16; MARENA 2008, p. 25). On protecting Panama’s biological diversity of scarlet macaws taken from the wild the Caribbean coast, commercial was Law 23 (1967) on the protection is forbidden in Colombia, although harvesting occurs of species such as and conservation of wildlife (Parker et regulations are not always followed and scarlet macaws, which is not currently al. 2004, p. III–2). Another important scarlet macaws are involved in illegal subject to a harvesting quota and are piece of legislation is Resolution DIR– trade in the country (CITES 2001, p. 8). sold on the local market (MARENA 002–80 (1980) that identifies 82 species The Colombian National Army and 2008, p. 25). in danger of extinction and bans National Police are cooperating with the Nicaragua’s adoption of CITES has led hunting, capturing, buying, selling, or Ministry of the Environment to protect to improvement in the management and exporting of all species included in this the country’s wildlife and combat illegal regulation of domestic and international list (Parker et al. 2004, p. III–2). Scarlet wildlife trafficking, much of that wildlife trade. Nonetheless, the existing macaw is one of these species. Other illegally acquired wildlife is intercepted legal framework is inadequate for the important regulatory mechanisms near the northern Colombian coasts protection and sustainability of include Resolution DIR–003–80 (1980) (Pedraza 2015, unpaginated). domestic wildlife trade (McGinley et al. that regulates wildlife in captivity and 2009, p. 22). Furthermore, its importation and exportation, and the Summary of Illegal Capture and Trade nonregulatory instruments, such as Wildlife Law 24 (1995), which Legal international trade is not a monitoring, research, education, and establishes that wildlife is part of the current threat because of international information, are poorly, if at all, used in natural heritage of Panama and provides laws such as CITES, the WBCA, and the oversight of commercial wildlife for the protection, restoration, research, similar stricter measures under trade in Nicaragua (McGinley et al. management and development of the European Union legislation that restrict 2009, p. 22). country’s genetic resources, including the trade of wild scarlet macaws. All

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range countries have laws and policies birds from the Chiquibul Forest Reserve Scarlet macaws may use partially that aim to prevent illegal capture and in Belize (Schmidt 2013, abstract). Gene cleared and cultivated landscapes if the trade of scarlet macaws, although some flow occurs between nest sites in landscape provides dietary hunting and capture continues. Guatemala and Belize, and levels of requirements and maintains enough However, illegal capture for the genetic diversity are high in the tri- large trees because this species is domestic pet trade within most range national region (Schmidt and Amato dependent on larger, older trees that countries occurs at a level that is likely 2008, p. 137), but the Belize population have large nesting cavities. However, to negatively impact the species may be more isolated from the scarlet macaws have a better chance of throughout all of the range of subspecies Guatemala and Mexico populations surviving in large tracts of forest where A. m. cyanoptera, and in the range of (Brightsmith 2016, in litt., p. 8). The suitable cavities are more common than the subspecies A. m. macao in Costa isolation of populations and subsequent in open and small forest remnants Rica and Panama. Because capture for loss of genetic exchange would impact (Inigo-Elias 1996, p. 91). the pet trade is ongoing and poses a the population at different timescales. In Commercial exploitation of scarlet threat to scarlet macaws in these the short term, populations may suffer macaw chicks may further contribute to regions, we conclude that the regulatory the deleterious consequences of inbreeding depression and loss of mechanisms addressing this threat in inbreeding; over the long term, the loss genetic diversity. However, other large, these regions are inadequate. of genetic variability diminishes a long-lived avian species have species’ capacity to adapt to changes in demonstrated significant retention of Summary of Factor D the environment (Blomqvist et al. 2010, molecular diversity after marked We found threats discussed under entire; Reed and Frankham 2003, pp. declines, thus indicating that longevity Factors A and B to be threats to the 233–234; Nunney and Campbell 1993, of the species may act as an intrinsic species throughout all of the range of pp. 236–237; Soule´ and Simberloff buffer against the rapid loss of genetic subspecies A. m. cyanoptera, except on 1986, pp. 28–29; Franklin 1980, pp. variation (Schmidt 2013, pp. 132–133). Isla Coiba, Panama; and in the range of 140–144). But the presence of high genetic the subspecies A. m. macao in Costa Negative impacts associated with variation in long-lived species may Rica (Factor B only), Panama, and small population size and vulnerability mask demographic instability Colombia west of the Andes (Factor A to random demographic fluctuations or introduced by habitat alteration and only). The existing regulatory natural catastrophes may be further overexploitation, resulting in a sudden mechanisms do not appear to be magnified by synergistic interactions and marked loss of diversity (Schmidt adequate to address threats, primarily with other threats, such as those 2013, p. 133). Systematic removal of because these countries lack resources discussed in Factors A and B. scarlet macaw nestlings over extended to effectively enforce all their laws. Small populations that are declining periods of time has likely produced an Therefore, we conclude that the existing can be especially vulnerable to habitat unstable age distribution in the tri- regulatory mechanisms are not adequate loss (O’Grady et al. 2004, pp. 513–514). national region (Mexico, Guatemala, and to protect subspecies A. m. cyanoptera As bird assemblages in forest habitat are Belize), heavily skewed toward older throughout all of its range, and the reduced because the size of the habitat individuals with low recruitment (Clum northern DPS of A. m. macao from the is reduced, smaller areas are less likely 2008, p. 79). threats of deforestation and to provide the essential resources for Historically, the scarlet macaw in overutilization. species such as scarlet macaw that have Mesoamerica existed in much higher large ranges. Thus, deforestation in numbers in more continuous habitat. Factor E: Other Natural or Manmade combination with other negative Currently, the scarlet macaw occurs in Factors Affecting the Species’ Continued impacts can have profound effects and relatively small and fragmented Existence potentially reduce a species’ effective populations within Mesoamerica; most Small Population Size and Synergistic population (the proportion of the actual populations in this region are believed Effects of Threats population that contributes to future to contain approximately 100 to 700 generations) by orders of magnitude individuals, with only two populations Small, isolated populations place (Gilpin and Soule´ 1986, p. 31). For potentially containing more than 1,000 species at greater risk of local example, an increase in habitat individuals. The total population size extirpation or extinction due to a variety fragmentation can separate populations for scarlet macaws in Mesoamerica is of factors, including loss of genetic to the point where individuals can no likely no greater than 5,000 individuals. variability, demographic and longer disperse and breed among habitat Overall, suitable habitat is becoming environmental stochasticity, and natural patches, causing a shift in the increasingly limited and is not likely to catastrophes (Lande 1995, entire; demographic characteristics of a expand in the future. Therefore, the Lehmkuhl and Ruggiero 1991, p. 37; population and a reduction in genetic species’ reproductive and life-history Gilpin and Soule´ 1986, pp. 25–33; Soule´ fitness (Gilpin and Soule´ 1986, p. 31). traits, combined with its limited and and Simberloff 1986, pp. 28–32; Shaffer This risk is especially applicable for fragmented habitat, increases the 1981, p. 131; Franklin 1980, entire). scarlet macaws in Mesoamerica, where species’ vulnerability to deforestation Stochastic events that put small the species was once wide-ranging but and overutilization in the A. m. populations at risk include, but are not has lost a significant amount of its cyanoptera and northern DPS of A. m. limited to, variation in birth and death historical range due to habitat loss and macao subspecies due to the small size rates, fluctuations in gender ratio, degradation. Large forests areas have of the species’ populations. inbreeding depression, and random been removed throughout Mesoamerica environmental disturbances such as fire and the large tracts of forest that remain, Competition for Nest Cavities and climatic shifts (Blomqvist et al. such as the Maya and Lacandon Forests, Competition for suitable nest cavities 2010, entire; Gilpin and Soule´ 1986, p. the transnational forest in the Mosquitia limits reproductive success by limiting 27; Shaffer 1981, p. 131). region, and the transnational forest on the available nesting sites and thus Overall levels of genetic variation in the border of Costa Rica and Panama, limiting the number of pairs that can the scarlet macaw remain high, but a have almost been cut off from each other breed, or by causing nest mortality as a decrease in diversity was noted among by deforestation (Bray 2010, p. 93). result of agonistic interactions.

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Intraspecific competition between and Costa Rica reported bees attacking project changes in habitat in areas of the different pairs of scarlet macaws, and nests with eggs and chicks and that the species’ range, either from the effects of competition with pairs of other macaw bees usurped nesting cavities, resulting climate change or from the effects of species, is reported to be intense in in the failure of the scarlet macaw nest climate change in combination with some areas (Renton and Brightsmith (Inı´go-Elias 1996, p. 61; Garcia et al. deforestation (Imbach et al. 2011, 2009, p. 5; Inigo-Elias 1996, p. 96; 2008, p. 52). Additionally, breeding abstract; Marengo et al. 2011, entire; Nycander 1995, p. 428). pairs of scarlet macaws were attacked Asner et al. 2010, entire; Vergara and Competition for nesting sites occurs when they approached the nest cavity Scholz 2010, entire; Malhi et al. 2009, throughout the scarlet macaw’s range. In (Inı´go-Elias 1996, p. 61; Garcia et al. entire; Malhi et al. 2008, entire; Nepstad Mexico, species including other 2008, p. 52). Because these bees occur et al. 2008, entire). However, high levels psittacines (Amazona farinosa, throughout the scarlet macaw’s range in of uncertainty remain in projecting Amazona autumnalis), toucans Central and South America and have habitat changes within the species’ (Ramphastos sulfuratus), and demonstrated a negative effect on scarlet range (see review by Davidson et al. falconiforms (Herpetotheres macaw nesting, we assume these bees 2012, entire), and there is no consensus cachinnans) breed synchronously with are competitors for nest cavities on the type or extent of habitat changes scarlet macaws and compete to use the throughout the scarlet macaw’s range, that will occur. Therefore, because the same nest cavities (Inı´go-Elias 1996, p. but we are unaware of any other data or scarlet macaw is tolerant of a relatively 61). In Costa Rica, quality nest sites information regarding the magnitude of broad range of ecological conditions; appear to be in demand because at least these impacts on scarlet macaw nesting occurs in a variety of habitat types four pairs of scarlet macaws were seen success. including wet forest, dry forest, and competing for the same nest cavity, savanna provided they contain suitable Climate Change which may be a limiting factor in the nest cavities and roosting sites; has a successful fledgling in the population Our analyses under the Act include broad diet including nonnative species; (Vaughan et al. 2003, p. 10). Additional consideration of ongoing and projected and is known to inhabit patchworks of avian nest competitors include changes in climate and the effects of any forest and human-modified landscapes, chestnut-mandibled toucan such change. Described in general we assume the scarlet macaw is likely (Ramphastos swainsonii), barred forest terms, climate refers to the mean and to adapt to some level of change in its falcon (Micrastur semitorquatus), and variability of different types of weather environment provided its essential yellow-napped parrot (Amazona conditions over a long period of time, needs are met. Overall, we are unaware auropalliata) (Vaughan et al. 2003, p. which may be reported as decades, of any information indicating that the 10). At a remote site in southeastern centuries, or thousands of years. The effects of climate change are now Peru, approximately 70 percent of the term ‘‘climate change’’ thus refers to a causing, or will in the future cause, nesting attempts involved competition change in the mean or variability of one declines in the scarlet macaw over nests (Brightsmith 2010, or more measures of climate (e.g., population. unpaginated). Competition for nest sites temperature, precipitation) that persists with other macaws was found to be the for an extended period, typically Summary of Factor E primary cause of failure of nests with decades or longer, and whether the Small population size and chicks. Scarlet macaws and red-and- change is due to natural variability, competition for next cavities may be green macaws (Ara chloropterus) human activity, or both threats to the scarlet macaw in some frequently compete for nest cavities, (Intergovernmental Panel on Climate parts of its range in Mesoamerica and which have been recorded annually. Change (IPCC) 2007, p. 78). Various northwest Colombia. Populations have a The smaller and less competitive scarlet types of changes in climate can have high level of genetic diversity, but they macaws are at a disadvantage, perhaps direct or indirect effects on species, and remain vulnerable to stochastic contributing to their use of a wider these may be positive or negative demographic and environmental events range of cavity resources (Renton and depending on the species and other because of their small populations. Brightsmith 2009, p. 5). relevant considerations, such as the Competition for nest cavities may be a Africanized honey bees (Apis effects of interactions with non-climate limiting factor and likely reduces mellifera scutellata) are also reported to conditions (e.g., habitat fragmentation). reproductive success. The general be a serious competitor with scarlet We use our expert judgment to weigh consensus is that the scarlet macaw’s macaws for nest cavities (Garcia et al. information, including uncertainty, in range is going to become hotter and 2008, p. 52; Vaughan et al. 2003, p. 13; our consideration of various aspects of drier; however, the scarlet macaw is Inigo-Elias 1996, p. 61). Africanized the effects of climate change that are tolerant of a relatively broad range of honey bees are an exotic species relevant to the scarlet macaw. ecological conditions. Because the originally introduced in Brazil in 1956 Several studies project various species persists in small and mostly (Whitfield et al. 2006, p. 644). They changes in climate in Mesoamerica and isolated populations, threats often subsequently spread throughout South the Amazon by the mid- to late century operate synergistically, particularly and Central America, displacing or sooner (Karmalkar et al. 2011, entire; when populations of a species are naturalized European honey bees (Apis Kitoh et al. 2011, entire; Giorgi and Bi decreasing. Thus, the initial effects of mellifera), and arriving in Mexico, 2009, entire; Anderson et al. 2008, one threat factor can exacerbate the Guatemala, and Belize around 1986 entire; Cook and Vizy 2008, entire; Li et effects of other threats (Gilpin and Soule´ (Whitfield et al. 2006, pp. 643–644; al. 2008, entire; Christensen et al. 2007, 1986, pp. 25–26). Clarke et al. 2002 and Rogel et al. 1991, pp. 892–896). Although there are Within the preceding review of the in Berry et al. 2010, p. 486; Fierro et al. uncertainties in these models and five factors, we have identified threat 1987, unpaginated). Africanized honey variation in projections, the general factors A and B that may have bees occur at higher densities and are trajectory under most scenarios is one of interrelated impacts on this species, more aggressive than naturalized increased warming in Mesoamerica and particularly in Mesoamerica. The European honey bees (Rogel 1991 and the Amazon, and decreased species’ productivity in Mesoamerica Clarke et al. 2002, in Berry et al. 2010, precipitation in Mesoamerica and some may be reduced because of any of these p. 486). Studies in Mexico, Guatemala, areas of the Amazon. Several studies threats, either singularly or in

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combination. For example, deforestation reintroduction programs to conserve Veracruz, Mexico, was assessed by reduces the amount of nesting cavities, scarlet macaw throughout its range in obtaining data on abundance, habitat which increases competition among Mesoamerica. use, and date of pet trade. Only three pairs of scarlet macaws and other species out of the nine species Reintroduction of Ara macao species for nesting sites. Deforestation previously reported remain in this area cyanoptera and the infrastructure that may (De Labra et al. 2010, p. 599). Scarlet accompany it creates access to Mexico macaw was not recorded, and there is a previously inaccessible areas, thereby In 1993, Xcaret began a program of consensus of local and historical opening up new areas of the species’ scarlet macaw reproduction in captivity, extinction of the Ara macao in this range to the threat of poaching and developing and using the best protocols region (Schaldach and Escalante 1997 further habitat loss. Therefore, because for hand rearing, and establishing new and Winker 1997, in De Labra et al. the populations of scarlet macaw are procedures to facilitate parental rearing 2010, p. 607). Since that time, La Otra Opcio´n is a small and mostly isolated in of the chicks without human 336-ac (136-ha) private ecological Mesoamerica, and these small intervention (Raigoza Figueras 2014, p. reserve and breeding center for populations are subject to a combination 51). The aim is to rear captive-bred endangered species in the Los Tuxtlas of threats, we believe that small macaws that will adapt to the wild Biosphere Reserve buffer zone has population size is a contributing stressor successfully and not require post-release worked to reintroduce scarlet macaws in to scarlet macaws throughout supplemental feeding (Raigoza Figueras the Los Tuxtlas region. In 2014, scarlet Mesoamerica, including the entire range 2014, p. 48). The release program began macaws were reintroduced to this area of subspecies A. m. cyanoptera and the in 2013. Xcaret supplies captive scarlet after disappearing for 40 years, and to range of A. m. macao in Costa Rica, macaws for reintroduction at two sites Panama, and northwest Colombia. date, more than 100 scarlet macaws in Mexico: (1) Palenque, Chiapas; and have been released (Raigosa et al 2016, Conservation Measures (2) Los Tuxtlas, Veracruz (Xcaret 2014, in Defenders of Wildlife 2016, in litt., p. unpaginated). Reintroduction of Scarlet Macaws 4; Mexico Daily News 2017, The Palenque, Chiapas, release site is unpaginated; Escalante 2016, Reintroduction efforts for the scarlet located in forested habitat of Aluxes unpaginated). Many captive-bred scarlet macaw have occurred throughout the Ecopark of Palenque, a wildlife rescue macaws remain in the wild with pairing range of A. m. cyanoptera and the and rehabilitation center that observed and potential nesting (Mexico northern DPS of the southern subspecies encompasses 44 ha (108 ac). This site is Daily News 2017, unpaginated; A. m. macao. We briefly discussed some approximately 0.5 km (0.3 mi) from Escalante 2016, unpaginated). Thus, this of the reintroduction efforts in our July Palenque National Park (Amaya et al. reintroduction effort appears moderately 6, 2012, and April 7, 2016, proposed 2015, p. 457) and more than 100 km (62 successful integrating scarlet macaws rules to list the scarlet macaw (77 FR mi) away from the nearest current wild into the wild population in Mexico. 40222 and 81 FR 20302, respectively). population (Brightsmith in litt. 2016, p. The reintroduction programs in However, based on public and peer 21). All scarlet macaws used for Palenque and Los Tuxtlas were aligned reviewer comments we received, we are reintroduction were captive bred at with the IUCN guidelines and the incorporating additional information Xcaret Ecopark. recommendations made by White et al. regarding these conservation efforts and In the April 7, 2016, proposed rule (81 2012. After the first year of programs that reintroduce captive-bred FR 20302), we identified the program in implementation in Palenque, the and confiscated scarlet macaws back Palenque, Chiapas, Mexico, in which 96 number of reintroduced and surviving into the wild within their respective scarlet macaws were released between macaws raises the number of extant historical ranges. We received April 2013 and June 2014, with a 91 macaws in the wild in Mexico by about information on some of the release sites percent survival rate as of May 2015, 34 percent (Estrada 2014, p. 360). and reintroduction programs and including nine nesting events and Considering Palenque and Los Tuxtlas describe many of them, although we successful use of wild foods by released together, the population of scarlet may not have information on every birds (Estrada 2014, p. 345). Results of macaws in Mexico has increased up to reintroduction program occurring for the reintroduction program in Palenque, 82 percent in 3 years (Rodriguez 2016, scarlet macaws. Most, if not all, of the Chiapas, show that the dietary diversity unpaginated; Lopez 2018, unpaginated). reintroduction sites are within, adjacent and breadth of the reintroduced scarlet to, or at least within flight distance of macaws closely approaches that of wild Guatemala currently existing populations. macaws; the reintroduced birds have the The Wildlife Conservation Society Because of the increasing number of capacity to find and track wild food (WCS) started working in Guatemala in reintroduction projects involving sources; they have very low mortality in 1992, with the mission of conserving the various species worldwide, the IUCN the released population (9 percent); they MBR as one of Mesoamerica’s most Species Survival Commission published have had nine successful nesting events, important wildlife conservation areas. guidelines for reintroductions to help including seven in natural cavities The MBR is the last stronghold for ensure that reintroduction efforts (Estrada, unpublished, in Amaya et al. scarlet macaws in Guatemala and achieve intended conservation benefits 2015, p. 471); and they have expanded contains the most important nesting and do not cause adverse side effects of their foraging and activity range outside area for the species in the country. The greater impact (IUCN/SSC 2013, entire; of the release site (Amaya et al. 2015, WCS has worked to reduce poaching, IUCN/SSC 1998, entire). Additionally, pp. 466–471). This reintroduction protect nesting sites from deforestation, recommendations were made specific to appears successful at integrating monitor nesting success and parrot reintroductions based on a review captive-reared scarlet macaws into the distribution, construct artificial nests, of previous releases and reintroductions wild and could be a model for provide environmental education in of psittacines worldwide (White et al. reintroduction efforts throughout the local communities, and create a captive- 2012, entire). We considered these range. release program (WCS 2016, pp. 6–16). guidelines and recommendations when During the years of 2008–2010, the In addition, they started a veterinarian evaluating the effectiveness of the status of parrot species in Los Tuxtlas, evaluation program, supplementary

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feeding, and management of wild chicks animals, particularly scarlet macaw Pacifico 2017, unpaginated; Boyd and during nesting season (WCS 2018, chicks. McNab 2008, p. x). Isla Zacate Grande unpaginated). In June 2016, WCS placed The FCD rangers patrol the Chiquibul is approximately 35 km (22 mi) six rehabilitated chicks in safe scarlet Forest, collaborate with the Scarlet Six, (overwater) from the Cosigu¨ ina macaw nests (Boyd 2016, in litt., p. 9). and receive support from the Belize Peninsula, an overland flight distance With these interventions, they have Defense Force. Their goal is to conserve within documented range for scarlet increased the number of fledglings per the natural and cultural resources of the macaws (Boyd and McNab 2008, p. x). nest (WCS 2018, unpaginated; WCS western Chiquibul-Maya Mountains Although no formal records are kept, 2016, p. 11). WCS Guatemala is also (FCD 2016, p. 4). In addition to nesting activity has been observed in working in collaboration to eradicate protecting scarlet macaws in the wild, artificial nests placed in natural hollows wildlife trafficking between Belize and the FCD also started a captive-rearing (Raigoza Figueras 2014, p. 50). However, Guatemala. program modeled after successful as a model, there are concerns about the The Wildlife Rescue and Conservation programs in Mexico and Guatemala reintroduction at this site because Association (Asociacio´n Rescate y (Harbison 2017, unpaginated). If a nest disease testing was not performed; there Conservacio´n de Vida Silvestre cannot be effectively protected by the was no documentation of the project; (ARCAS)) is a rehabilitation and rangers while the chicks are growing, or the birds have no fear of humans and breeding-for-release center for if a nest produces a third chick that will continue to depend on regular Guatemalan wildlife that has been not survive, FCD removes the chicks supplemental food; and the birds appear confiscated from the black market by the from the nest and brings them to the lab. to have been conditioned to nest in Guatemalan government. Since its All eight macaws in 2015’s cohort inappropriate situations (i.e., low to the establishment, the ARCAS Rescue successfully fledged, but it took until ground), which makes them highly Center has grown into one of the largest January 2016 before they left the area for vulnerable to human and non-human and most complex wildlife good (Harbison 2017, unpaginated). The predators alike. High security and long- FCD also signed an agreement with rehabilitation centers in the world and term daily maintenance is required WCS in Guatemala and Natura y a leader in training programs for other (Boyd and McNab 2008, p. x; Bjork Ecosistemas Mexicanos A.C. in July to wildlife rescue groups and veterinary 2008, pp. 17–18). coordinate research, management, and A reintroduction of scarlet macaw at students (Oakland Zoo 2018, conservation efforts of scarlet macaws in the Copa´n archaeological site (Parque unpaginated). In October 2015, in Pete´n, the Maya Forest (FCD 2016, p. 13). In Arqueolo´gico Copa´n Ruinas) in ARCAS released nine captive-bred January 2016, FCD signed an extended Honduras began in 2011. The World scarlet macaws into the wild in agreement of cooperation with Parrot Trust, the Macaw Mountain Bird Guatemala, which was the first time Asociacio´n Balam for the protection of Park and Nature Reserve, the Institute of captive-bred scarlet macaws were the Chiquibul ecosystem for the period Anthropology and History of Honduras released into the wild in Guatemala. At 2016–2020. This agreement primarily and the Association Copa´n have least 60 percent of the released birds seeks to jointly promote the protection organized a long-running program to survived more than 10 months on their of the Chiquibul Maya Mountains return the scarlet macaw to the Parque own, showing that they successfully ecosystem and reduce conflict among Arqueolo´gico Copa´n Ruinas, a national adapted to the environment and were communities located on the Belize and park (Raigoza Figueras 2014, pp. 50–51). able to feed and fly on their own. This Guatemala adjacency zone (FCD 2016, The Macaw Mountain scarlet macaw program for rehabilitation and release p. 9). breeding program is releasing birds into has generated quantifiable results that the forests surrounding the Copa´n Ruins Honduras can be used to prove the viability of (Boyd 2016, in litt., p. 6). Most of the such a strategy in the reinforcement of In Honduras, scarlet macaws have birds come from private donations of the depleted scarlet macaw population been released into multiple sites. pet birds; others were confiscated by the of the Sierra del Lacando´n National Releasing scarlet macaws at the Isla Environment Office of the Public Park, which is where the scarlet macaws Zacate Grande biological station in Ministry (Macaw Mountain 2017, were released and is one of the largest Honduras began around 1996–1997 unpaginated). In 2018, scarlet macaws and best protected natural areas in the (Raigoza Figueras 2014, p. 50; Boyd and released produced seven chicks (World MBR (ARCAS 2016, pp. 5–6). In 2016, McNab 2008, p. x). A private reserve Parrot Trust 2019, unpaginated). We are they planned to release 10 more scarlet released scarlet macaws on the island. not aware of the release methods or if macaws (Boyd 2016, in litt., p. 10), but This reintroduction effort started with this program takes into account the we do not have any information four chicks; a few years later, they IUCN guidelines and White et al. (2012) regarding the results of this release. received and released another five recommendations. However, this Belize scarlet macaws (adults and chicks) of program has been judged a resounding unknown origin (Boyd and McNab success (Macaw Mountain 2019, In Belize, the protection of the scarlet 2008, p. x). About 20 scarlet macaws unpaginated; Asociacio´n Copan 2017, macaw in the Chiquibul region is have been released at the site (Bjork unpaginated). provided by numerous organizations, 2008, pp. x, 17–18; Raigoza Figueras A macaw conservation and local some of which have joined efforts to 2014, p. 50). Some of the reintroduced development program was started in the improve protection with the goal of birds have ranged outside the release Mosquitia region of Honduras by the increasing the chance of survival for this point to nearby communities and the Lafeber Company, Dr. Kim Joyner, species (Hagen Avicultural Research adjacent island of Amapala, Honduras. indigenous peoples of several villages, Institute 2015, unpaginated). For Released birds have been observed the Forestry Service of Honduras, example, the Scarlet Six Biomonitoring around the Gulf of Fonseca, where Paso Universidad Nacional Auto´noma Team (Scarlet Six), Friends for Pacifico is conducting a scarlet macaw Honduras, and the Universidad Conservation and Development (FCD), conservation program on the Cosigu¨ ina Nacional de Agricultura (Boyd 2016, in and the Belize Self-Defense Forces work Peninsula, Nicaragua (see ‘‘Nicaragua,’’ litt., p. 7; Lafeber 2018, unpaginated). together to reduce illegal gold mining; below), which hosts a small wild This program started in 2010, and in timber extraction; and poaching of population of 20 to 50 birds (Paso 2011 through 2012, confiscated scarlet

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macaws were released at the village Wildlife Refuge, which are all within 50 unpaginated). This reintroduction Mabita. Once these birds grew large km (31 mi) of each other. It is difficult program has ceased because a viable enough to fly, they were released from to determine how these populations will population has been established that is their cages, slowly learning to fly fare over time because these populations large enough to potentially connect with around the village. Government officials are fairly isolated, but these three populations in the ACOSA that are have released more birds, for a total of release sites could help repopulate the farther north along the coast (Tiskita 22, and approximately 16 regularly visit Nicoya Peninsula (Brightsmith 2016, in Jungle Lodge 2018, unpaginated). Thus, the village, coming in every morning to litt., p. 15). The Punta Islita release site releases could potentially aid in feed. The earliest birds released in is situated in the tropical moist forest of recolonization of the macaw Mabita (in 2011) have an active nest; Costa Rica’s North Pacific coast; wild population’s original range, to the extent they have produced two chicks, which scarlet macaws had been locally extinct that the habitat within that range demonstrates that the program can in this area for decades. Between 2011 remains suitable. successfully raise birds to reproduce in and 2018, 37 scarlet macaws were In total, the past and ongoing the wild (Lafeber 2018, unpaginated). released at this site (Ara Project 2017, reintroduction efforts have added However, it is not ideal that the birds unpaginated). We have no data hundreds of scarlet macaws to the wild are so dependent on humans for food. concerning the current status of the in Costa Rica. Additionally, most We are not aware of the release methods released birds. At Curu´ , scarlet macaws reintroduction projects conduct or if this program takes into account the were released starting in January 1999. environmental education at a local level IUCN guidelines and White et al. (2012) Ten of the 13 birds released were still and attract additional media attention at recommendations. alive after 4 years, and pairs have the local and national level. As a result, attempted to nest in natural tree cavities each reintroduction project educates the Nicaragua in two different years, but no chicks public about the importance of scarlet Paso Pacifico works throughout have been produced (Brightsmith et al. macaws and of conservation and the Nicaragua, focusing on the natural 2005, p. 468). At Playa Tambor, we do environment in general (Brightsmith ecosystems of Central America’s Pacific not have information on the number of 2016, in litt., p. 22). slope (Boyd 2016, in litt., p. 5). In 2015, scarlet macaws released into the wild or Impacts of Reintroducing Captive-Bred they launched a scarlet macaw the success of the releases at this site. Scarlet Macaws Into the Wild conservation program in the Cosigu¨ ina Within the scarlet macaw’s range in Volcano area of northern Nicaragua Releases of captive scarlet macaws southwestern Costa Rica, a few could increase the wild populations (Paso Pacifico 2017, unpaginated). With reintroduction programs exist around financial support from the Loro Parque because many of the reintroduced the Gulf (Golfo Dulce) and the Osa captive-raised and confiscated birds are Fundacio´n, among others, community Peninsula. These include Santuario released adjacent to existing rangers protect and monitor the Silvestre de Osa (SSO), which releases populations or at least within the range remaining scarlet macaws. Their birds close to Piedras Blancas National that scarlet macaws are known to objectives are to establish accurate Park; Zoo Ave, which releases birds in disperse, and some of the release birds baseline information about the the Golfito area; Amigos de las Aves, have adapted to surviving in the wild by population, focusing on demographics, which releases offspring of confiscated finding mates and food and nesting nesting success, and habitat use in the birds in Alajuela, Punta Banco (Dear et resources similar to what wild scarlet reserve; to strengthen the ability of the al. 2010, pp. 15–17; Forbes 2005, p. 97); macaws use. In addition, releases of Nicaraguan army to deter poachers; to and Tiskita Lodge and the Ara project, scarlet macaws could potentially aid in involve and empower the local which releases birds in Tiskita Jungle recolonization of the population’s community to protect nesting scarlet Lodge’s private reserve also in Punta original range in Mesoamerica, to the macaws; and to increase awareness Blanco (Ara Project 2018, unpaginated). extent that the habitat within that range among Ministry of Environment officials These organizations receive and release remains suitable and programs are and the Nicaraguan environmental birds confiscated from poachers from all available to protect scarlet macaws in community (Loro Parque Fundacio´n parts of the country (Dear et al. 2010, p. the wild from poachers. Conversely, 2015, unpaginated). They have also 15). Seventy-seven scarlet macaws were releases of captive scarlet macaws could been working closely with families from released in 1997; as of 2002, almost 90 potentially pose a threat to wild La Salvia, the village nearest to the percent of the released birds were still populations by exposing wild birds to scarlet macaw nesting area, through an alive (Dear et al. 2010, p. 16). diseases for which wild populations educational program involving Additionally, the range of birds released have no resistance, invoking behavioral birdwatching and other field-based at Punta Banco has grown to reach 84 changes in wild macaws that negatively activities that highlight the significance 2 2 km (32 mi ) (Forbes 2005, in Dear et al. affect their survival, or compromising of the scarlet macaw and the dry 2010, p. 17). The breeding center in the genetic integrity of wild populations tropical forests at Cosigu¨ ina Alajuela has since closed and moved to (Dear et al. 2010, p. 20; Schmidt 2013, (pasopacifico 2017, unpaginated). Two Tiskita (Tiskita Jungle Lodge 2018, pp. 74–75; also see IUCN 2013, pp. 15– scarlet macaw chicks have safely unpaginated). Between 2002 and 2014, 17). However, generally speaking, fledged, which was the first successful nine groups of birds were released in disease risks are small because the macaw nest documented in this area in Tiskita, most of which are thriving and probable frequency of occurrence is low over 20 years (pasopacifico 2017, reproducing in the wild (Ara Project (see Factor C discussion in 77 FR unpaginated). 2018, unpaginated; Tiskita Jungle Lodge 40237–40238; July 6, 2012). Reintroduction of Ara macao macao 2018, unpaginated). To date, the survival rate is close to 90 percent, and Other Conservation Programs Costa Rica at least five pairs have successfully Conservation programs operate in On the Nicoya Peninsula in fledged chicks in natural cavities since some areas of the scarlet macaw’s range northwestern Costa Rica, scarlet macaws 2008. Over 75 scarlet macaws have been but not throughout its entire range. are currently released at Punta Islita, released into the wild at this site Many partner organizations work Playa Tamboor, and Curu´ National (Tiskita Jungle Lodge 2018, together to implement these

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conservation programs that study and considered the five factors in assessing The scarlet macaw is a popular pet aim to increase the viability of scarlet whether the scarlet macaw meets the species within its range countries, and macaw populations in the wild. To the definition of an endangered species or overutilization as a result of poaching is extent that we have information threatened species. We examined the a significant threat to A. m. cyanoptera indicating the effects of these programs best scientific and commercial (except on Isla Coiba, Panama). The on the scarlet macaw’s status, we information available regarding factors scarlet macaw is susceptible to included information in the Factors affecting the status of the scarlet macaw. overharvest because it is a long-lived Affecting the Species, above. In We reviewed the petition, information species with a low reproductive rate and addition, general conservation measures available in our files, information slow to recover from harvesting such as education, use of artificial nest provided by peer review and public pressures. Thus, removal of individuals boxes, and nest monitoring are comments, and other available year after year can inhibit population discussed below. Because too many published and unpublished growth and cause local extirpation. organizations exist to list them all here, information. Evidence suggests poaching occurs at we summarize the general actions taken. significant levels in the Maya Forest Final Determination for the Northern Organizations in certain regions where region, even with conservation Subspecies (Ara macao cyanoptera) scarlet macaws persist conduct the measures such as monitoring and following conservation efforts: The northern subspecies of scarlet protecting nesting sites in Guatemala (1) Implement education programs macaw, Ara macao cyanoptera, exists in and Belize, and is a significant threat in that promote the scarlet macaw, as well Mexico, Guatemala, Belize, Honduras, Honduras and Nicaragua. Poaching is as sustainable forest management, Nicaragua, eastern Costa Rica, and Isla exacerbated by habitat removal because because much of the territory in the Coiba in Panama. Little quantitative it increases access to previously scarlet macaw’s range is held by local data on historical populations are inaccessible areas, thereby opening up communities or indigenous people (Ara available, but evidence indicates that new areas to poaching. Project 2017, unpaginated; Vaughan et the range of this subspecies has been Most if not all of the countries within al. 1999, entire; WCS 2010, entire; FAO greatly reduced and the total current the range of A. m. cyanoptera have 2010a, pp. 238–239, Blaser et al. 2011, population of A. m. cyanoptera, based regulations aimed at conserving forested pp. 312, 346; Marineros and Vaughan on available data (see Table 1), is lands, biodiversity, and prohibit 1995, pp. 462–463); estimated to be approximately 2,000 to poaching of scarlet macaws. However, (2) Protect and monitor nests to 3,000 individuals. these countries are not able to reduce poaching, which has reduced The primary threats we identified to adequately enforce their regulations due overall nest poaching in Belize from A. m. cyanoptera are habitat loss due to to lack of resources, conflicts over land higher than 90 percent to less than 30 activities that cause deforestation and ownership that lead to illegal logging percent, with 2017 the second year in a forest degradation (Factor A), poaching and expansion of agriculture and row that no known nests were poached, for the pet trade and sustenance (Factor pasture, and lack of oversight or a and has greatly decreased the severity of B), and small population size that works governing body to enforce the poaching in Guatemala (Harbison 2017, in combination with the other threats regulations. unpaginated; Garcia et al. 2008, p. xii); (Factor E). The existing regulatory Some range countries employ (3) Construct artificial nest boxes, mechanisms are not adequate to protect conservation measures such as which increases nesting sites and the species from these threats to the protecting nesting sites from poachers ultimately recruitment (Vaughan et al. level that the species is not in danger of and reintroducing captive-bred scarlet 2003, p. 10; Brightsmith 2000a, entire; extinction (Factor D). macaws into the wild. While these Brightsmith 2000b, entire; Brightsmith Destruction of forest habitat is one of programs have had success protecting 2005, p. 297; Nycander et al. 1995, pp. the main causes of the decline of A. m. nests from poachers and slightly 435–436); and cyanoptera. Deforestation rates in increasing the number of scarlet macaws (4) Use local conservation Mesoamerica, excluding Costa Rica, are in the wild in some populations (see organizations to coordinate conservation the highest in Latin America due to Conservation Measures, above), many of activities with stakeholders (Vaughan et expanding agriculture, cattle ranching, the reintroduction programs do not have al. 2005, p. 123; WCS 2008, entire). and selective and often illegal logging. data to show long-term viability of Throughout the range of the subspecies reintroduced birds. Therefore, while Finding where most of the species’ historical conservation measures have had a Section 4 of the Act (16 U.S.C. 1533) habitat has been eliminated, positive impact on the populations of A. and the implementing regulations in deforestation is rapidly occurring, m. cyanoptera, these conservation part 424 of title 50 of the Code of including in all the forested areas where actions occur in small sections of the Federal Regulations (50 CFR part 424) scarlet macaws currently exist (except range of the subspecies and the threats set forth procedures for adding species Isla Coiba, Panama). Activities that lead identified above are ongoing. to, removing species from, or to deforestation and forest degradation Scarlet macaws in Mesoamerica reclassifying species on the Federal directly eliminate the scarlet macaw’s maintain a high level of genetic Lists of Endangered and Threatened tropical forest habitat by removing the diversity, but because of the few Wildlife and Plants. Section 3 of the Act trees that support the species’ essential populations and the small numbers in defines an ‘‘endangered species’’ as needs for nesting, roosting, and food. each of the populations, and their ‘‘any species which is in danger of Scarlet macaws are known to use virtual isolation from other populations extinction throughout all or a significant partially cleared and cultivated due to deforestation, they remain portion of its range,’’ and a ‘‘threatened landscapes, but they are only able to do vulnerable to extirpation and extinction. species’’ as ‘‘any species which is likely so if the landscape maintains enough Fewer than 5,000 scarlet macaws remain to become an endangered species within large, older trees that provide the in this relatively large geographic area. the foreseeable future throughout all or essential needs of the species. Because of the extent of the decline in a significant portion of its range.’’ As Poaching, mainly for the pet trade but the range and numbers of Ara macao required by the Act, we conducted a also for sustenance, is the other main cyanoptera due to ongoing habitat review of the status of the species and cause of decline of A. m. cyanoptera. destruction and degradation, poaching,

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the lack of enforcement of existing which is one of the only locations where unlisted species will substantially regulatory mechanisms addressing these a very small population of scarlet facilitate the enforcement and further threats, and the small population sizes macaws exists on mainland Panama. the policy of this [Act].’’ All applicable that work in combination with the other Additionally, the best available prohibitions and exceptions for species threats, we find that these threats place information indicates that the treated as threatened under section 4(e) A. m. cyanoptera in danger of population in northwest Colombia faces of the Act due to similarity of extinction. Therefore, on the basis of the significant ongoing threats from appearance to a threatened or best scientific and commercial deforestation within the foreseeable endangered species will be set forth in information available, we find that A. m. future. No current population estimates a rule issued under section 4(d) of the cyanoptera meets the definition of an are available for northwest Colombia, Act. ‘‘endangered species’’ in accordance and this region is reported to have large Several factors make differentiating with the definition in the Act. tracts of suitable forest habitat, but between scarlet macaw listable entities many areas in northwest Colombia are difficult. First, the scarlet macaw Final Determination for the Northern considered deforestation hotspots. Thus, subspecies, Ara macao macao and Ara DPS of Southern Subspecies (Ara macao macao cyanoptera, primarily differ in macao) although the two largest populations currently appear to be increasing, they the coloration of their wing coverts (a The range of Ara macao macao north both are small and their total range type of feather) and wing size. But these and west of the Andes has been greatly represents only a portion of the range of differences are not always apparent, reduced and fragmented. The scarlet the northern DPS. Therefore, we find especially in birds from the middle of macaw has been almost extirpated from that the best available information the species’ range (which may include mainland Panama and much of its indicates that current threats to scarlet crosses between A. m. cyanoptera and former range in Costa Rica. Its macaws in northwest Colombia A. m. macao), sometimes making it remaining distribution is on the Pacific (deforestation); ongoing poaching of difficult to visually differentiate slope of Costa Rica, in the Chiriquı´ scarlet macaws in Costa Rica and between subspecies (Schmidt 2011, province and at the southern end of the mainland Panama; ongoing, small-scale, pers. comm.; Weidenfeld 1994, pp. 99– Azuero Peninsula of Veraguas, near subsistence logging in Panama; 100). According to information received Cerro Hoya National Park in Panama, inadequate enforcement of existing from the Service’s Forensics Laboratory, and in northwest Colombia. regulations; and the small population many scarlet macaw remains submitted Because information indicates that the sizes of scarlet macaws in this region for examination by Office of Law ACOPAC and ACOSA populations in put this DPS in danger of extinction in Enforcement special agents and wildlife Costa Rica, which make up the bulk of the foreseeable future. On the basis of inspectors do not consist of intact the northern DPS of A. m. macao, may the best scientific and commercial carcasses; rather, evidence is usually in be stable and likely increasing and information available, we find that the the form of partial remains, detached expanding their range on the Pacific northern DPS of A. m. macao meets the feathers, and artwork incorporating their slope of Costa Rica, it is reasonable to definition of a ‘‘threatened species’’ in feathers. Therefore, identification of the conclude that the northern DPS of A. m. accordance with the definition in the subspecies or the geographic origin of macao is not currently in danger of Act. these birds is difficult or improbable extinction and does not meet the without genetic analysis, which would definition of an ‘‘endangered species’’ Similarity of Appearance add considerable difficulties and cost under the Act. A threatened species’’ is Final Determination for Southern DPS for law enforcement. ‘‘any species which is likely to become of Southern Subspecies (Ara macao Second, we are not aware of any an endangered species within the macao) information indicating that foreseeable future throughout all or a distinguishing morphological significant portion of its range.’’ The Act In our proposed rule we found that differences between the northern and does not define the phrase ‘‘foreseeable the southern DPS of the southern southern DPSs of A. m. macao would future,’’ but we interpret it to describe subspecies A. m. macao did not warrant allow for visual identification of the the extent to which we can reasonably listing as an endangered species or a origin of a bird of this subspecies. rely on the predictions about the future threatened species based on its status. Lastly, aviculturists have bred the in making determinations about the However, we determined that it is species without regard for taxa, future conservation status of the species. advisable to treat the southern DPS as a resulting in crosses of the two We conclude that it is reasonable to rely threatened species based on its subspecies (A. m. cyanoptera and A. m. on the information contained in the similarity of appearance to the northern macao) that maintain a combination of studies discussed above under ‘‘Factors DPS of A. m. macao and subspecies characteristics of either parent being Affecting the Species’’ involving land- crosses of A. m. cyanoptera and A. m. present in trade (Wiedenfeld 1994, p. use trends and population sizes, as well macao. Section 4(e) of the Act 103). As a result, the similarity of as the information regarding authorizes the treatment of a species, appearance between an unlisted enforcement of existing regulations and subspecies, or distinct population southern DPS of A. m. macao and other factors that negatively influence segment as endangered or threatened if: subspecies crosses to the listed northern the species, to make a determination ‘‘(A) [S]uch species so closely resembles DPS of A. m. macao and A. m. about the future conservation status of in appearance, at the point in question, cyanoptera may result in the ability to the northern DPS of A. m. macao. a species which has been listed pass off a protected specimen as an Poaching continues and remains a pursuant to [section 4 of the Act] that unlisted DPS or unlisted subspecies concern for the future viability of the enforcement personnel would have cross and poses an additional threat to species for the foreseeable future. In substantial difficulty in attempting to the northern DPS of A. m. macao and Panama, poaching of scarlet macaws differentiate between the listed and subspecies A. m. cyanoptera. Therefore, was one factor that led to the virtual unlisted species; (B) the effect of this we consider this difficulty in discerning extirpation of this species from the substantial difficulty is an additional an unlisted southern DPS and unlisted mainland, and poaching remains a threat to an endangered or threatened subspecies crosses from the listed concern at Cerro Hoya National Park, species; and (C) such treatment of an northern DPS of A. m. macao and

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subspecies A.m. cyanoptera as an and our regulations at 50 CFR 17.21. authorization for an otherwise additional threat to the listed entities. These include, among others, prohibited activity would need to be The close resemblance between the prohibitions on take within the United obtained under the general permit listed and the unlisted entities would States, within the territorial seas of the provisions for threatened species found make differentiating the listed scarlet United States, or upon the high seas; at 50 CFR 17.32. For activities otherwise macaws (the subspecies Ara macao import; export; and shipment in prohibited under the 4(d) rule involving cyanoptera and the northern DPS of the interstate or foreign commerce in the specimen of the northern DPS of the subspecies Ara macao macao) from course of a commercial activity. scarlet macaw (A. m. macao), such those that are not listed (individuals of Exceptions to the prohibitions for activities would require authorization the southern DPS of A. m. macao and endangered species may be granted in pursuant to the general permit subspecies crossings (A. m. cyanoptera accordance with section 10 of the Act provisions for threatened species found and A. m. macao)) difficult for law and our regulations at 50 CFR 17.22. at 50 CFR 17.32. enforcement to enforce. Therefore, we The Act does not specify particular determine that treating the southern prohibitions and exceptions to those Import and Export DPS of A. m. macao and subspecies prohibitions for threatened species. The 4(d) rule will apply to all crosses (A. m. cyanoptera and A. m. Instead, under section 4(d) of the Act, commercial and noncommercial macao) under the 4(e) similarity of the Secretary, as well as the Secretary of international shipments of live and dead appearance provisions of the Act will Commerce depending on the species, southern subspecies of scarlet macaws substantially facilitate law enforcement was given the discretion to issue such and subspecific crosses of A. m. macao actions to protect and conserve scarlet regulations as deemed necessary and and A. m. cyanoptera and their parts macaws. If the southern DPS of A. m. advisable to provide for the and products, including the import and macao or subspecies crosses (A. m. conservation of such species. The export of personal pets and research cyanoptera and A. m. macao) were not Secretary also has the discretion to samples. In most instances, the rule will listed, importers and exporters could prohibit by regulation with respect to adopt the existing conservation inadvertently or purposefully any threatened species any act regulatory requirements of CITES and misrepresent a specimen of A. m. prohibited under section 9(a)(1) of the the WBCA as the appropriate regulatory cyanoptera or the northern DPS of A. m. Act. For the scarlet macaw, the Service provisions for the import and export of macao as a specimen of the unlisted is exercising our discretion to issue a certain scarlet macaws. The import into entity, creating a loophole in enforcing 4(d) rule. By adopting the existing the Act’s protections for listed species of parrot 4(d) rule for the scarlet macaw, the United States and export from the scarlet macaw. Thus, the listing will we are incorporating all prohibitions United States of birds taken from the facilitate Federal and State law- and provisions of 50 CFR 17.31 and wild after the date this species is listed enforcement efforts to curtail 17.32. However, import and export of under the Act; conducting an activity unauthorized import and trade in A. m. certain scarlet macaws into and from the that could take or incidentally take cyanoptera or the northern DPS of A. m. United States and certain acts in scarlet macaws; and foreign commerce macao. interstate commerce are allowed must meet the requirements of 50 CFR Extending the prohibitions of the Act without a permit under the Act, as 17.31 and 17.32, including obtaining a to the similar entities through this explained below. permit under the Act. However, the 4(d) listing of those entities due to similarity The 4(d) rule will apply to the rule allows a person to import or export of appearance under section 4(e) of the southern subspecies of scarlet macaw without a permit issued under that Act Act and providing applicable (Ara macao macao) and to crosses of the if the specimen either: (1) Was held in prohibitions and exceptions in a rule two scarlet macaw subspecies, A. m. captivity prior to the date this species is issued under section 4(d) of the Act will macao and A. m. cyanoptera. We are listed under the Act; or (2) is a captive- provide greater protection to A. m. including subspecies crosses in this rule bred specimen, provided the export is cyanoptera and the northern DPS of A. because aviculturists have bred the authorized under CITES and the import m. macao. Although the 4(e) provisions species without regard to their taxa, is authorized under CITES and the of the Act do not contain criteria as to resulting in crosses of the two WBCA. If a specimen was taken from whether a species listed under the subspecies being present in trade. All the wild and held in captivity prior to similarity of appearance provisions prohibitions of 50 CFR 17.31 will apply the date this species is listed under the should be treated as endangered or to A. m. macao and subspecies crosses Act, the importer or exporter must threatened, we find that treating the of A. m. macao and A. m. cyanoptera, provide documentation to support that southern DPS of A. m. macao and except that import and export of certain status, such as a copy of the original subspecies crosses (A. m. cyanoptera A. m. macao and subspecies crosses into CITES permit indicating when the bird and A. m. macao) as threatened is and from the United States and certain was removed from the wild or museum appropriate because the 4(d) rule, for acts in interstate commerce will be specimen reports. For captive-bred the reasons mentioned in our finding allowed without a permit under the Act, birds, the importer must provide either below, provides adequate protection for as explained below. For activities a valid CITES export/re-export these entities. For these reasons, we are otherwise prohibited under the 4(d) rule document issued by a foreign proposing to treat the southern DPS of involving specimens of the southern Management Authority that indicates A. m. macao and subspecies crosses (A. DPS of the scarlet macaw and that the specimen was captive-bred by m. cyanoptera and A. m. macao) as subspecies crosses, such activities will using a source code on the face of the threatened due to the similarity of require authorization pursuant to the permit of either ‘‘C,’’ ‘‘D,’’ or ‘‘F.’’ appearance pursuant to section 4(e) of similarity-of-appearance permit Exporters of captive-bred birds must the Act. regulations at 50 CFR 17.52. If an provide a signed and dated statement applicant is unable to meet the issuance from the breeder of the bird confirming 4(d) Rule criteria for a similarity-of-appearance its captive status, and documentation on When a species is listed as permit and demonstrate that the scarlet the source of their breeding stock. The endangered, certain actions are macaw in question is a subspecific cross source codes of C, D, and F for CITES prohibited under section 9 of the Act or originated from the southern DPS, permits and certificates are as follows:

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(C) Animals bred in captivity in markets of Central and South America. Required Determinations accordance with Resolution Conf. 10.16 Thus, the general prohibitions on National Environmental Policy Act (42 (Rev.), as well as parts and derivatives import and export contained in 50 CFR U.S.C. 4321 et seq.) thereof, exported under the provisions 17.31, which extend only within the of Article VII, paragraph 5 of the jurisdiction of the United States, would We have determined that we do not Convention. not regulate such activities. need to prepare an environmental (D) Appendix-I animals bred in Accordingly, we find that the import assessment, as defined under the captivity for commercial purposes in and export requirements of the 4(d) rule authority of the National Environmental operations included in the Secretariat’s provide the necessary and advisable Policy Act of 1969, in connection with Register, in accordance with Resolution conservation measures for this species. regulations adopted under section 4(a) Conf. 12.10 (Rev. CoP15), and This 4(d) rule streamlines the permitting of the Endangered Species Act. We Appendix-I plants artificially published a notice outlining our reasons process by deferring to existing laws propagated for commercial purposes, as for this determination in the Federal that are protective of scarlet macaws in well as parts and derivatives thereof, Register on October 25, 1983 (48 FR the course of import and export and not exported under the provisions of Article 49244). VII, paragraph 4, of the Convention. requiring permits under the Act for (F) Animals born in captivity (F1 or certain types of activities. References Cited subsequent generations) that do not Interstate Commerce A complete list of references cited in fulfill the definition of ‘‘bred in this rulemaking is available on the captivity’’ in Resolution Conf. 10.16 Under the 4(d) rule, a person may internet at http://www.regulations.gov (Rev.), as well as parts and derivatives deliver, receive, carry, transport, or ship and upon request from the U.S. Fish and thereof. Ara macao macao and subspecies Wildlife Service, Ecological Services, The 4(d) rule’s provisions regarding crosses (A. m. macao and A. m. Branch of Delisting and Foreign Species captive-bred birds apply to birds bred in cyanoptera) in interstate commerce in (see FOR FURTHER INFORMATION CONTACT). the United States and abroad. The terms the course of a commercial activity, or Authors ‘‘captive-bred’’ and ‘‘captivity’’’ used in sell or offer to sell in interstate the 4(d) rule are defined in the commerce A. m. macao and subspecies The primary authors of this rule are regulations at 50 CFR 17.3 and refer to crosses without a permit under the Act. staff members of the Branch of Delisting wildlife produced in a controlled At the same time, the prohibitions on and Foreign Species, Ecological Services environment that is intensively take under 50 CFR 17.21, as presently Program, U.S. Fish and Wildlife Service. manipulated by man from parents that mated or otherwise transferred gametes extended to threatened species under 50 List of Subjects in 50 CFR Part 17 CFR 17.31, will apply under this 4(d) in captivity. Although the 4(d) rule Endangered and threatened species, requires a permit under the Act to rule, and any interstate commerce Exports, Imports, Reporting and ‘‘take’’ (including harm and harass) a activities that could incidentally take A. recordkeeping requirements, scarlet macaw, our regulations at 50 m. macao and subspecies crosses or Transportation. CFR 17.3 establish that ‘‘take’’ when otherwise prohibited acts in foreign applied to captive wildlife does not commerce will require a permit under Regulation Promulgation include generally accepted animal- 50 CFR 17.32. Accordingly, we amend part 17, husbandry practices; breeding We have no information that suggests subchapter B of chapter I, title 50 of the procedures; or provisions of veterinary current interstate commerce activities Code of Federal Regulations, as set forth care for confining, tranquilizing, or are associated with threats to the scarlet below: anesthetizing, when such practices, macaw or would negatively affect any procedures, or provisions are not likely PART 17—ENDANGERED AND efforts aimed at the recovery of wild THREATENED WILDLIFE AND PLANTS to result in injury to the wildlife. populations of the species. Therefore, We assessed the conservation needs of we are not placing into effect any the scarlet macaw in light of the broad ■ 1. The authority citation for part 17 prohibitions on interstate commerce of protections provided to the species continues to read as follows: scarlet macaw within the United States. under CITES and the WBCA. The scarlet Authority: 16 U.S.C. 1361–1407; 1531– macaw is included in Appendix I of Because the species will be otherwise 1544; 4201–4245, unless otherwise noted. protected in the course of interstate CITES, a treaty that contributes to the ■ 2. Amend § 17.11(h) by adding entries commercial activities under the take conservation of the species by regulating for ‘‘Macaw, scarlet’’, ‘‘Macaw, scarlet provisions and foreign commerce international trade and ensuring that [Northern DPS]’’, ‘‘Macaw, scarlet provisions contained in 50 CFR 17.31 as trade in Appendix-I species is not [Southern DPS]’’, and ‘‘Macaw, scarlet detrimental to the survival of the applied to this species, and [Subspecies crosses]’’ in alphabetical species. The purpose of the WBCA is to international trade of this species is order under BIRDS to the List of promote the conservation of exotic birds regulated under CITES, we find this 4(d) Endangered and Threatened Wildlife, to and to ensure that imports of exotic rule contains all the prohibitions and read as follows: birds into the United States do not harm authorizations necessary and advisable them. The best available data indicate for the conservation of the scarlet § 17.11 Endangered and threatened that the current threat of trade of the macaw. wildlife. scarlet macaw stems mainly from illegal * * * * * trade that stays within the domestic (h) * * *

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Listing citations and Common name Scientific name Where listed Status applicable rules

******* BIRDS

******* Macaw, scarlet ...... Ara macao cyanoptera ...... Wherever found ...... E 84 FR [insert Federal Register page where the document begins], 2/26/2019. Macaw, scarlet [Northern DPS] Ara macao macao ...... Colombia (northwest of the T 84 FR [insert Federal Register Andes), Costa Rica (Pacific page where the document slope), Panama (mainland). begins], 2/26/2019; 50 CFR 17.41(c).4d Macaw, scarlet [Southern DPS] Ara macao macao ...... Bolivia, Brazil, Colombia T(S/A) 84 FR [insert Federal Register (southeast of the Andes), Ec- page where the document uador, French Guiana, Guy- begins], 2/26/2019; 50 CFR ana, Peru, Suriname, Ven- 17.41(c).4d ezuela. Macaw, scarlet [Subspecies Ara macao macao X Ara Costa Rica, Nicaragua (Atlantic T(S/A) 84 FR [insert Federal Register crosses]. macao cyanoptera. slope border region). page where the document begins], 2/26/2019; 50 CFR 17.41(c).4d

*******

■ 3. Amend § 17.41 by revising (Ara macao macao and Ara macao (E) For scarlet macaws: March 28, paragraphs (c) introductory text and cyanoptera)). 2019 (the date this species was listed (c)(2)(ii) introductory text and by adding * * * * * under the Endangered Species Act of paragraph (c)(2)(ii)(E) to read as follows: (2) * * * 1973, as amended (Act) (16 U.S.C. 1531 (ii) Specimens held in captivity prior et seq.)). § 17.41 Special rules—birds. to certain dates: You must provide * * * * * * * * * * documentation to demonstrate that the Dated: February 4, 2019. (c) The following species in the parrot specimen was held in captivity prior to the dates specified in paragraph family: Salmon-crested cockatoo Margaret E. Everson, (c)(2)(ii)(A), (B), (C), (D), or (E) of this (Cacatua moluccensis), yellow-billed Principal Deputy Director Exercising the section. Such documentation may parrot (Amazona collaria), white Authority of the Director for the U.S. Fish include copies of receipts, accession or and Wildlife Service. cockatoo (Cacatua alba), hyacinth veterinary records, CITES documents, or [FR Doc. 2019–03165 Filed 2–25–19; 8:45 am] macaw (Anodorhynchus hyacinthinus), wildlife declaration forms, which must BILLING CODE P and scarlet macaw (Ara macao macao be dated prior to the specified dates. and scarlet macaw subspecies crosses * * * * *

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701...... 1601 48...... 3669 872...... 4998 154...... 2799 702...... 1601 71 ...... 961, 2718, 3095, 3097, 1308...... 2448 155...... 2800 703...... 1601 3098, 3101, 3673, 3674, Proposed Rules: 165...... 2479 704...... 1601 3676, 3677, 3679, 4991, 50...... 5968 328...... 2483, 4154 705...... 1601 4993, 5352, 5951 201...... 6204 334...... 3739 708a...... 1601 73...... 3299 310...... 6204 708b...... 1601 95...... 963 312...... 5968 34 CFR 709...... 1601 97 ...... 2441, 2443, 2719, 2720, 347...... 6204 36...... 971 710...... 1601 3973, 3975, 3977, 3978, 352...... 6204 668...... 971 715...... 1601 4994, 4996 812...... 5968 Proposed Rules: 717...... 1601 Proposed Rules: 1305...... 5395 106...... 4018 723...... 1601 13...... 3614 725...... 1601 21...... 5605 22 CFR 37 CFR 741...... 1601 39 ...... 2465, 2467, 2791, 2793, Proposed Rules: 201...... 3693 745...... 1601 2796, 3131, 4012, 4387, 171...... 1419 202...... 3693, 3698 746...... 1601 5609, 5611, 5614, 5617, 203...... 3351 203...... 3699 747...... 1601, 2052 5620, 5960 385...... 1918 748...... 1601 71 ...... 3349, 3730, 5014, 5016, 23 CFR Proposed Rules: 749...... 1601 5017, 5019, 5392, 5622 1270...... 2731 2...... 4393 750...... 1601 107...... 3732, 3856 1275...... 2731 11...... 4393 760...... 1601, 4953 Proposed Rules: 201...... 1661 790...... 1601 15 CFR 658...... 2071 791...... 1601 6...... 2445 38 CFR 792...... 1601 902...... 2725 25 CFR 930...... 5308 950...... 3101 3...... 2449, 4336 Proposed Rules: 932...... 5308 8...... 2449, 4336 16 CFR 30...... 3135 1026...... 1356 14...... 2449, 4336 19...... 2449, 4336 1277...... 5308 1...... 3980 26 CFR 1411...... 2437 Proposed Rules: 20...... 2449, 4336 1 ...... 1838, 2952, 6076 1610...... 4975 Ch. II ...... 3134 21...... 2449, 4336 Proposed Rules: 38...... 5952 Proposed Rules: 17 CFR 1...... 1014, 3015 39...... 5952 1...... 3062 54...... 5969 3...... 3062, 6107 143...... 3103 Proposed Rules: 200...... 5202 4...... 1678, 3354 5...... 3062 27 CFR 6...... 3062 201...... 4906 17...... 5629 23...... 3062 229...... 2402 Proposed Rules: 38...... 2093 240...... 2402, 4906 9...... 3353 24...... 3062 39...... 2093 242...... 5202 32...... 3062, 6107 29 CFR 39 CFR 34...... 3062 Proposed Rules: 44...... 2778 Ch. I ...... 3350 30...... 3301 20...... 3107 46...... 3345 9...... 3350 4022...... 3983 3035...... 974 36...... 3350 160...... 3062 Proposed Rules: Proposed Rules 37...... 3350 192...... 3062 1404...... 1420 3020...... 1420 38...... 3350 206...... 3062 1601...... 5624 39...... 3350 40 CFR 208...... 3062 1614...... 4015 43...... 3350 211...... 3062 1626...... 5624 19...... 2056, 5955 75...... 2778 2590...... 5969 52 ...... 976, 1610, 1615, 2060, 215...... 3062 230...... 5393 217...... 3062, 6107 4001...... 2075 2063, 2449, 2738, 3302, 232...... 5393 4204...... 2075 3305, 3701, 3703, 3705, 223...... 3062 239...... 5393 4206...... 2075 3708, 3711, 3986, 3991, 225...... 3062 240...... 4614, 5393 4207...... 2075 4338, 5000, 5004, 5598, 238 ...... 3062, 4002, 5014 255...... 2778 4211...... 2075 5601 248...... 2778 270...... 1286, 5393 4219...... 2075 60 ...... 3108, 3985, 3986 251...... 3062 274...... 1286, 5393 61...... 3108 252...... 4002, 5014 31 CFR 303...... 3062 18 CFR 62...... 3712 27...... 3105 324...... 3062, 6107 11...... 1359 63 ...... 2742, 3108, 3308 327...... 5380 70...... 1615, 3108 33...... 6069 32 CFR 337...... 2366, 3062 250...... 966 80...... 2453 347...... 3062 385...... 966, 3982 75...... 3681 122...... 3324 100...... 968 351...... 2778 Proposed Rules: 124...... 3324 362...... 3062 7...... 2469 101...... 968 125...... 3324 365...... 1653, 3062 35...... 993 162...... 4710 180 ...... 2456, 4340, 4345, 6081 390...... 1653, 3062 141...... 1412, 5968 199...... 4326 261...... 5816 614...... 5389 385...... 1412, 5968 279...... 969 262...... 5816 715...... 5957 807...... 5353 264...... 5816 1041...... 4252, 4298 20 CFR 809a...... 2734 265...... 5816 30...... 3026 813...... 5353 266...... 5816 14 CFR 404...... 4323 884...... 5354 268...... 5816 39 ...... 2437, 2707, 2709, 2713, 408...... 4323 270...... 5816 33 CFR 2715, 3285, 3288, 3290, 416...... 4323 271...... 5603 3297, 4310, 4313, 4315, Proposed Rules: 100...... 3301 273...... 5816 4318, 4320, 4685, 4686, 404...... 1006 117...... 1401, 2735 Proposed Rules: 4692, 4694, 4987, 5350, 416...... 1006 165 ...... 969, 2736, 4333, 5354, Ch. I ...... 3396 5584, 5587, 5589, 5592, 6080 49...... 1690 5595, 6059, 6062, 6064, 21 CFR Proposed Rules: 52 ...... 1015, 1016, 1021, 1025, 6067 216...... 4696 100...... 4390, 6107 1037, 1690, 2109, 2801,

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3354, 3358, 3369, 3373, 45 CFR 54...... 2132 49 CFR 3376, 3381, 3384, 3387, 1149...... 1402 65...... 2132 107...... 3993 3389, 3740, 3742, 3744, 73...... 2485 1158...... 1402 110...... 3993 4019, 4021, 4025, 4403, 1607...... 1404 76...... 4039 Proposed Rules: 4407, 4411, 4422, 4426, 1611...... 1408 97...... 4742 5020, 5032 10...... 2137, 5403 60...... 2484, 2485 Proposed Rules: 48 CFR 144...... 5969 563...... 2804 62...... 1039 146...... 5969 Ch. 2 ...... 4360 1002...... 1046 63...... 1570, 2670 147...... 5969 204...... 4362 1312...... 1046 70...... 5032 206...... 4364 81 ...... 4029, 4422, 4426 46 CFR 211...... 4366 110...... 2483, 4154 50 CFR 506...... 2459 212 ...... 4362, 4368, 4370 112...... 2483, 4154 Proposed Rules: 215...... 4364, 4368 17...... 6278 116...... 2483, 4154 234...... 4364 229...... 5356 117...... 2483, 4154 515...... 2125 235...... 4364 600...... 4733 122...... 2483, 4154 47 CFR 236...... 4371 622 .....1631, 2759, 3723, 4733, 131...... 3395 239...... 4368 151...... 4741 0...... 2753, 6085 5955 247...... 4370 174...... 2115 1 ...... 1618, 2460, 2461, 2753, 635...... 3724, 5358 252 ...... 4362, 4368, 4370 180...... 1691, 2115 5008 648 .....1632, 2463, 2760, 3341, 501...... 1410, 3714 230...... 4154 5...... 2753 4373, 5377 511...... 3714 232...... 2483, 4154 25...... 2462 665...... 2767, 5378 30...... 1618 517...... 3714 271...... 5650 679 .....2067, 2068, 2723, 2776, 300 .....2116, 2122, 2483, 4033, 32...... 4711 519...... 1410 36...... 4351 532...... 3714 3342, 3726, 3727 4054 680...... 2723 302...... 2483, 4154 54...... 4711 536...... 3714 697...... 4733 401...... 2483, 4154 64...... 1409 543...... 3714 65...... 4711 546...... 3714 Proposed Rules: 42 CFR 73...... 2753 552...... 1410, 3714 17...... 6110 Proposed Rules: 74...... 2753 5215...... 3112 216...... 5977 88...... 5972 Proposed Rules: 5242...... 3113 217...... 3136 5252...... 3113 493...... 1536 1...... 2485, 4035 300...... 3403, 4758 1001...... 2340 2...... 5654 Proposed Rules: 622...... 4758 5...... 4742 215...... 4429 648...... 5035 44 CFR 25 ...... 2126, 4742, 5654 217...... 4429 64...... 978, 3338 32...... 2132 806...... 1014

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Register but may be ordered H.R. 439/P.L. 116–7 enacted public laws. To in ‘‘slip law’’ (individual National FFA Organization’s subscribe, go to http:// LIST OF PUBLIC LAWS pamphlet) form from the Federal Charter Amendments listserv.gsa.gov/archives/ Superintendent of Documents, Act (Feb. 21, 2019; 133 Stat. publaws-l.html This is a continuing list of U.S. Government Publishing 478) public bills from the current Office, Washington, DC 20402 Last List February 20, 2019 session of Congress which Note: This service is strictly have become Federal laws. (phone, 202–512–1808). The for E-mail notification of new This list is also available text will also be made Public Laws Electronic laws. The text of laws is not online at http:// available on the Internet from Notification Service available through this service. www.archives.gov/federal- GPO’s Federal Digital System (PENS) PENS cannot respond to register/laws. (FDsys) at http://www.gpo.gov/ specific inquiries sent to this fdsys. Some laws may not yet The text of laws is not PENS is a free electronic mail address. be available. published in the Federal notification service of newly

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