Unknown. Final rule

5,418 words·~25 min read·/register/2019/04/30/2019-08700·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2019-04-30.xml --- 84 83 Tuesday, April 30, 2019 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Amendments to the National List of Allowed and Prohibited Substances for 2017 National Organic Standards Board Recommendations (Livestock and Handling), 18133-18136 2019-08700 NOTICES 2019 Rates Charged for AMS Services, 18232-18236 2019-08701 Agricultural Research Agricultural Research Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 18238 2019-08690 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Forms Pertaining to the Scientific Peer Preview of ARS Research Projects, 18236-18238 2019-08689 Agriculture Agriculture Department See Agricultural Marketing Service See Agricultural Research Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 18239 2019-08677 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare and Medicaid Programs:

Risk Adjustment Data Validation, 18215-18216 2019-08691 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 18289-18290 2019-08644 Civil Rights Civil Rights Commission NOTICES Meetings: New York Advisory Committee, 18240 2019-08659 Meetings; Sunshine Act, 18239-18240 2019-08803 Coast Guard Coast Guard RULES Drawbridge Operations: Youngs Bay and Lewis and Clark River, Astoria, OR, 18140-18142 2019-08708 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;

Additions and Deletions, 18267-18268 2019-08693 Community Living Administration Community Living Administration NOTICES Single-Source Supplement: Christopher and Dana Reeve Foundation, 18290 2019-08635 Comptroller Comptroller of the Currency PROPOSED RULES Regulatory Capital Rule: Revisions to the Supplementary Leverage Ratio to Exclude Certain Central Bank Deposits of Banking Organizations Predominantly Engaged in Custody, Safekeeping and Asset Servicing Activities, 18175-18186 2019-08448 Corporation Corporation for National and Community Service NOTICES Privacy Act;

Systems of Records, 18268-18270 2019-08657 Defense Acquisition Defense Acquisition Regulations System RULES Defense Federal Acquisition Regulation Supplement: Contract Closeout Authority, 18153-18155 2019-08482 Restriction on the Acquisition of Certain Magnets and Tungsten, 18156-18160 2019-08485 Small Business Set-Asides for Architect-Engineer and Construction Design Contracts, 18160-18161 2019-08486 Technical Amendments, 18155-18156 2019-08488 Use of the Government Property Clause, 18161-18163 2019-08481 PROPOSED RULES Defense Federal Acquisition Regulation Supplement:

Modification of DFARS Clause “Cancellation or Termination of Orders”, 18225-18228 2019-08483 Modification of DFARS Clause “Orders for Facilities and Services”, 18228-18230 2019-08484 Performance-Based Payments, 18221-18225 2019-08487 Defense Department Defense Department See Defense Acquisition Regulations System See Navy Department NOTICES Meetings: Defense Health Board, 18270-18271 2019-08662 Privacy Act; Systems of Records, 18271-18272 2019-08751 Drug Drug Enforcement Administration RULES Interlocutory Appeals in Administrative Hearings, 18138-18140 2019-08705 NOTICES Decision and Order:

Palafox Pharmacy, 18320-18321 2019-08703 Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 18321-18322 2019-08702 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Public Education Financial Survey 2019-2021: Common Core of Data, 18272-18273 2019-08682 Meetings: National Assessment Governing Board, 18273-18274 2019-08649 Energy Department Energy Department See Federal Energy Regulatory Commission PROPOSED RULES Revisions to the DOE Contractor Employee Protection Program, 18164-18175 2019-08599 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;

Approvals and Promulgations: Maine; Infrastructure State Implementation Plan Requirements for the 2010 Sulfur Dioxide NAAQS, 18142-18144 2019-08650 Texas; Reasonably Available Control Technology in the Houston-Galveston-Brazoria Ozone Nonattainment Area, 18145-18151 2019-08710 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Indiana; Redesignation of the Indianapolis Sulfur Dioxide Nonattainment Area, 18195-18200 2019-08626 Texas; Infrastructure for the 2015 Ozone National Ambient Air Quality Standard, 18186-18191 2019-08711 Wisconsin;

Infrastructure SIP Requirements for the 2012 PM <sup>2.5</sup> NAAQS; Interstate Transport, 18191-18195 2019-08627 Updates to National Pollutant Discharge Elimination System eRule Data Elements to Reflect Municipal Separate Storm Sewer Systems General Permit Remand Rule, 18200-18215 2019-08733 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities, 18278-18279 2019-08643 Identification of Non-Hazardous Secondary Materials that are Solid Waste, 18279-18280 2019-08645 Implementation of Title I of the Marine Protection, Research, and Sanctuaries Act, 18277-18278 2019-08728 National Emission Standards for Hazardous Air Pollutants for Taconite Iron Ore Processing, 18282-18283 2019-08715 NESHAP for Mercury Cell Chlor-Alkali Plants (Renewal), 18282 2019-08717 NESHAP for Primary Magnesium Refining, 18280-18281 2019-08642 NSPS for Storage Vessels for Petroleum Liquids for Which Construction, Reconstruction or Modification Commenced After June 11, 1973 and Prior to May 19, 1978 (Renewal), 18281-18282 2019-08718 Approval of the Primacy Revision Application for the Public Water System Supervision Program from the State of Iowa, 18279 2019-08732 Pesticide Experimental Use Permit;

Application, 18283-18284 2019-08678 Federal Aviation Federal Aviation Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Carbon Offsetting and Reduction Scheme for International Aviation Monitoring, Reporting, and Verification Program, 18333-18334 2019-08684 Safety Statement Requirement for Manufacturers of Small Unmanned Aircraft, 18335-18336 2019-08739 Petition for Exemption; Summary: Erickson Aero Tanker, LLC, 18334-18335 2019-08737 Jonathan Dill, 18336 2019-08736 Midwest Turbine Service, 18337 2019-08735 Zee Aero, 18336-18337 2019-08738 Federal Deposit Federal Deposit Insurance Corporation PROPOSED RULES Regulatory Capital Rule:

Revisions to the Supplementary Leverage Ratio to Exclude Certain Central Bank Deposits of Banking Organizations Predominantly Engaged in Custody, Safekeeping and Asset Servicing Activities, 18175-18186 2019-08448 Federal Emergency Federal Emergency Management Agency NOTICES Flood Hazard Determinations; Changes, 18293-18294 2019-08697 Flood Hazard Determinations; Proposals, 18294-18298 2019-08698 2019-08730 2019-08731 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 18275-18277 2019-08679 2019-08680 Filing:

Western Area Power Administration, 18274-18275 2019-08681 Meetings; Sunshine Act, 18276 2019-08770 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions: Proposed Highway in Washington, 18337-18339 2019-08634 2019-08636 Federal Maritime Federal Maritime Commission NOTICES Controlled Carriers under the Shipping Act of 1984, 18284-18285 2019-08692 Federal Reserve Federal Reserve System PROPOSED RULES Regulatory Capital Rule: Revisions to the Supplementary Leverage Ratio to Exclude Certain Central Bank Deposits of Banking Organizations Predominantly Engaged in Custody, Safekeeping and Asset Servicing Activities, 18175-18186 2019-08448 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 18285-18289 2019-08714 2019-08716 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 18289 2019-08754 Fish Fish and Wildlife Service PROPOSED RULES Bald and Golden Eagle Protection Act and Migratory Bird Treaty Act; Religious Use of Feathers, 18230-18231 2019-08280 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Fish and Wildlife Permit Applications and Reports—Law Enforcement, 18309-18311 2019-08672 Foreign Assets Foreign Assets Control Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Remittance Forwarding Services and Travel and Carrier Services to Cuba, 18341-18342 2019-08647 Foreign Trade Foreign-Trade Zones Board NOTICES Authorization of Production Activity: Bloom Energy Corp., Foreign-Trade Zone 18, San Jose, CA, 18240 2019-08713 Driftwood LNG, LLC, Foreign-Trade Zone 87, Lake Charles, LA, 18240 2019-08712 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

USGS Water Use Data and Research Program Announcement, 18311-18312 2019-08632 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Community Living Administration See National Institutes of Health RULES Enforcement Discretion Regarding HIPAA Civil Money Penalties, 18151-18153 2019-08530 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 18291-18292 2019-08651 Meetings: Health Information Technology Advisory Committee; 2019 Schedule, 18290-18291 2019-08727 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.

Immigration and Customs Enforcement Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: HUD Standard Grant Application Forms, 18300-18301 2019-08750 Public Housing Flat Rent Exception Request Market Analysis, 18299-18300 2019-08749 Housing Notice for Revitalization Area Designation Criteria, 18307-18309 2019-08746 Tenant Protection Voucher Funding Awards for Fiscal Year 2018 for the Housing Choice Voucher Program, 18301-18307 2019-08747 Inter-American Inter-American Foundation NOTICES Meetings;

Sunshine Act, 18309 2019-08832 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See National Park Service Internal Revenue Internal Revenue Service NOTICES Request for Nominations: Electronic Tax Administration Advisory Committee, 18342-18343 2019-08648 International Trade Adm International Trade Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 18241 2019-08654 Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Hot-Rolled Steel Flat Products from Australia, 18241-18242 2019-08707 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Large Residential Washers from Korea and Mexico, 18319-18320 2019-08671 Justice Department Justice Department See Drug Enforcement Administration Land Land Management Bureau NOTICES Request for Nominations: Resource Advisory Councils, 18313-18315 2019-08723 Site-specific Advisory Councils, 18312-18313 2019-08724 Maritime Maritime Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 18339 2019-08525 NASA National Aeronautics and Space Administration NOTICES Charter Reestablishment: Federal Advisory Committee, 18322 2019-08688 National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 18322-18323 2019-08673 National Endowment for the Humanities National Endowment for the Humanities PROPOSED RULES Implementation of the Privacy Act of 1974, 18216-18220 2019-08753 National Foundation National Foundation on the Arts and the Humanities See National Endowment for the Humanities National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Fatality Analysis Reporting System; Correction, 18340 2019-08729 National Driver Register, 18339-18340 2019-08676 National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 18292 2019-08683 National Oceanic National Oceanic and Atmospheric Administration NOTICES Endangered and Threatened Species: Listing and Recovery Priority Guidelines, 18243-18259 2019-08656 Meetings: Evaluation of State Coastal Management Programs, 18265-18266 2019-08658 Fisheries of the Gulf of Mexico;

Southeast Data, Assessment, and Review, 18264-18265 2019-08663 Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review, 18266 2019-08665 Hydrographic Services Review Panel, 18264 2019-08661 Pacific Fishery Management Council, 18242-18243 2019-08664 South Atlantic Fishery Management Council, 18266 2019-08667 Takes of Marine Mammals Incidental to Specified Activities: Construction of the Vineyard Wind Offshore Wind Project, 18346-18381 2019-08666 National Wildlife Refuge Complex Research, Monitoring, and Maintenance Activities in Massachusetts, 18259-18264 2019-08744 National Park National Park Service NOTICES Inventory Completions:

Bureau of Land Management, Alaska State Office, Anchorage, AK, 18318 2019-08743 Native American Human Remains and Associated Funerary Objects in the Possession of the University of Denver Department of Anthropology and Museum of Anthropology, Denver Colorado, CO; Correction, 18318-18319 2019-08741 Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA, 18315-18316 2019-08740 University of South Alabama, Center for Archaeological Studies, Mobile, AL, 18316-18317 2019-08742 National Register of Historic Places:

Pending Nominations and Related Actions, 18317-18318 2019-08694 Navy Navy Department NOTICES Meetings: Board of Visitors of Marine Corps University, 18272 2019-08725 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemption and Combined License Amendment: Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4, Editorial and Consistency Changes, 18326-18327 2019-08721 Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4;

Administrative Changes to Align Initial Test Program with Regulatory Guide 1.68, 18323-18324 2019-08720 Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Clarification of ASME Code Section III Compliance and Alternative Requirements for ASME Section III Pressure Tests Conducted Following the Completion of ASME Section III Construction Activities, 18324-18326 2019-08719 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Invention Promoters/Promotion Firms Complaints, 18266-18267 2019-08674 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Qualifying District of Columbia Service, 18327-18328 2019-08655 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 18328 2019-08726 Postal Service Postal Service NOTICES Product Change: Priority Mail Negotiated Service Agreement, 18328-18329 2019-08646 Securities Securities and Exchange Commission RULES Disclosure of Order Handling Information, 18136-18138 2019-08675 NOTICES Meetings;

Sunshine Act, 18329 2019-08795 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 18329-18332 2019-08652 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Courier Drop-Off List for U.S. Passport Applications, 18332-18333 2019-08745 Office of Language Services Contractor Application Form, 18332 2019-08752 Surface Transportation Surface Transportation Board NOTICES Meetings:

Rail Energy Transportation Advisory Committee, 18333 2019-08709 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Maritime Administration See National Highway Traffic Safety Administration See Transportation Statistics Bureau Transportation Statistics Transportation Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Passenger Origin-Destination Survey Report, 18340-18341 2019-08706 Treasury Treasury Department See Comptroller of the Currency See Foreign Assets Control Office See Internal Revenue Service Immigration U.S.

Immigration and Customs Enforcement NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic bonds Online Access, 18299 2019-08641 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Disability Compensation, 18343 2019-08685 Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 18344 2019-08695 Research Advisory Committee on Gulf War Veterans' Illnesses, 18343-18344 2019-08696 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 18346-18381 2019-08666 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 84 83 Tuesday, April 30, 2019 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-17-0080; NOP-17-09] RIN 0581 AD78 National Organic Program: Amendments to the National List of Allowed and Prohibited Substances for 2017 NOSB Recommendations (Livestock and Handling) AGENCY:

Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: This final rule amends the National List of Allowed and Prohibited Substances (National List) section of the United States Department of Agriculture's (USDA's) organic regulations to implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule adds elemental sulfur to the National List for use in organic livestock production and reclassifies potassium acid tartrate from a non-agricultural substance to an agricultural substance and requires the organic form of the ingredient when commercially available.

This rule also corrects the amendatory instructions to ensure proper placement of the regulatory text. DATES: This final rule is effective May 30, 2019. FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, National Organic Program. Telephone:

(202)720-3252. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established the National List within part 205 of the USDA organic regulations (7 CFR 205.600 through 205.607). The National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990, as amended, (7 U.S.C. 6501-6522) (OFPA), and § 205.105 of the USDA organic regulations specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural and any nonsynthetic nonagricultural substance used in organic handling be on the National List. Under the authority of OFPA, the National List can be amended by the Secretary based on recommendations presented by the NOSB. Since the final rule establishing the National Organic Program

(NOP)became effective on October 21, 2002, USDA's Agricultural Marketing Service

(AMS)has published multiple rules amending the National List. This final rule amends the National List to implement NOSB recommendations on two amendments to the National List that were submitted to the Secretary on November 2, 2017. The amendments in this final rule are discussed in the section on Overview of Amendments below. II. Overview of Amendments The following provides an overview of the amendments to designated sections of the National List regulations. The background information on each substance and the basis for the NOSB recommendation were addressed in the proposed rule (83 FR 18744) and have not been included in this final rule. The NOSB evaluated each substance by applying the OFPA substance evaluation criteria to determine if the substance is compatible with organic production and handing. For each substance, AMS reviewed the recommendation submitted to the Secretary to determine if the OFPA evaluation criteria had been appropriately applied and whether the addition to or amendment of the National List would not supersede other federal regulations. Our review determined that the substances described in this final rule meet these conditions. Therefore, AMS accepted each NOSB recommendation and initiated this rulemaking. AMS received five comments on the proposed rule. After considering the received comments, AMS has determined that the addition of elemental sulfur to the National List for organic livestock production and amendment of potassium acid tartrate described in the proposed rule will be finalized without change. Section E of this final rule provides an overview of the received comments and AMS's response to these comments. § 205.603 Synthetic Substances Allowed for Use in Organic Livestock Production This final rule adds one substance, elemental sulfur, to § 205.603, synthetic substances allowed for use in organic livestock production. Elemental Sulfur This final rule amends § 205.603(b) of the National List to add elemental sulfur for use as a parasiticide to treat livestock and livestock housing as paragraph (b)(2). Elemental sulfur is added to the National List as a topical pesticide treatment in organic livestock production to repel mites, fleas, and ticks from livestock and livestock living quarters. Mites, fleas, and ticks are vectors of livestock diseases and may heavily infest livestock and livestock living quarters. Elemental sulfur is dusted on and rubbed into the feathers and hair of livestock and applied to interior surfaces of livestock housing. Elemental sulfur is also on the National List for use in organic crop production as an insecticide (including mite control), § 205.601(e); as a plant disease control, § 205.601(i); and as a plant or soil amendment, § 205.601(j). Organic livestock or poultry producers can use elemental sulfur as a topical treatment when preventive practices are inadequate to prevent mite, flea, or tick infestation. When organic livestock producers plan to use elemental sulfur as a topical pest control, certifying agents must ensure that preventive pest control practices along with the possible use of elemental sulfur are included in the producer's organic system plan. Agents must also verify implementation of preventive practices before approving the use of elemental sulfur during onsite inspection. § 205.605 Nonagricultural (Nonorganic) Substances Allowed as Ingredients In or On Processed Products Labeled as “Organic” or “Made With Organic (Specified Ingredients or Food Group(s))” This rule removes one substance, potassium acid tartrate, from § 205.605 and relists this substance in § 205.606. Potassium Acid Tartrate This final rule amends the National List to reclassify potassium acid tartrate from a nonagricultural substance listed in § 205.605(b) to an agricultural substance listed in § 205.606(q). Potassium acid tartrate is currently allowed as a synthetic substance for use in organic handling. Potassium acid tartrate has been on the National List in § 205.605(b) since October 2002. A 2017 technical report reviewed by the NOSB indicates that potassium acid tartrate is a byproduct of the wine making process and is extracted with water. Based upon this information, the NOSB during its October 31-November 2, 2017 meeting recommended reclassifying potassium acid tartrate as an agricultural substance and moving it to § 205.606 of the National List. This amendment to the USDA organic regulations requires organic handlers who use potassium acid tartrate to source an organic form of the ingredient. Only when organic potassium acid tartrate is not commercially available 1 can nonorganic potassium acid tartrate be used in organic handling. When certifying agents review handling organic system plans that include the use of potassium acid tartrate, they must ensure that organic potassium acid tartrate is used unless it is documented that organic potassium acid tartrate is not commercially available. Sourcing of potassium acid tartrate must also be verified during inspection. 1 See 7 CFR 205.606 and 7 CFR 205.2 for definition of “Commercially available.” III. Related Documents The NOSB proposal to add elemental sulfur to the National List and to re-designate the listing of potassium acid tartrate as a non-organic agricultural product on the National List was published on April 30, 2018. In addition, on May 30, 2017, a Notice was published in the **Federal Register** (82 FR 24659) announcing the fall 2017 NOSB meeting. One purpose of the meeting was to deliberate on substances either petitioned or recommended as amendments to the National List. IV. Statutory and Regulatory Authority The OFPA authorizes the Secretary to make amendments to the National List based on recommendations developed by the NOSB. Sections 6518(k) and 6518(n) of the OFPA authorize the NOSB to develop recommendations for submission to the Secretary to amend the National List and establish a process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. Section 205.607 of the USDA organic regulations sets forth the National List petition process. The current petition process (81 FR 12680, March 10, 2016) can be accessed through the NOP Program Handbook on the NOP website at *https://www.ams.usda.gov/rules-regulations/organic/handbook* . A. Executive Orders 12866 and 13771, and Regulatory Flexibility Act This rulemaking falls within a category of regulatory actions that the Office of Management and Budget

(OMB)has exempted from Executive Order 12866. Additionally, because this final rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. *See* OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs'” (February 2, 2017). The Regulatory Flexibility Act

(RFA)(5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The Small Business Administration

(SBA)sets size criteria for each industry described in the North American Industry Classification System (NAICS), to delineate which operations qualify as small businesses. The SBA has classified small agricultural producers that engage in crop and animal production as those with average annual receipts of less than $750,000. Handlers are involved in a broad spectrum of food production activities and fall into various categories in the NAICS Food Manufacturing sector. The small business thresholds for food manufacturing operations are based on the number of employees and range from 500 to 1,250 employees, depending on the specific type of manufacturing. Certifying agents fall under the NAICS subsector, “All other professional, scientific and technical services.” For this category, the small business threshold is average annual receipts of less than $15 million. AMS has considered the economic impact of this rulemaking on small agricultural entities. Data collected by the USDA National Agricultural Statistics Service

(NASS)and the NOP indicate most of the certified organic production operations in the U.S. would be considered small entities. According to the 2016 Certified Organic NASS Survey, 13,954 certified organic farms in the U.S. reported sales of organic products and total farm gate sales in excess of $7.5 billion. 2 Based on that data, organic sales average $541,000 per farm. Assuming a normal distribution of producers, we expect that most of these producers would fall under the $700,000 sales threshold to qualify as a small business. 2 U.S. Department of Agriculture, National Agricultural Statistics Service. September 2017. Certified Organic Survey, 2016 Summary. *http://usda.mannlib.cornell.edu/usda/current/OrganicProduction/OrganicProduction-09-20-2017_correction.pdf* . According to the NOP's Organic Integrity Database there are 9,633 certified handlers in the U.S. 3 The Organic Trade Association's 2017 Organic Industry Survey has information about employment trends among organic manufacturers. The reported data are stratified into three groups by the number of employees per company: Less than 5; 5 to 49; and 50 plus. These data are representative of the organic manufacturing sector and the lower bound

(50)of the range for the larger manufacturers is significantly smaller than the SBA's small business thresholds (500 to 1,250). Therefore, AMS expects that most organic handlers would qualify as small businesses. 3 Organic Integrity Database: *https://organic.ams.usda.gov/Integrity/.* Accessed on March 23, 2018. The USDA has 80 accredited certifying agents who provide organic certification services to producers and handlers. The certifying agent that reports the most certified operations, nearly 3,500, would need to charge approximately $4,200 in certification fees in order to exceed the SBA's small business threshold of $15 million. The costs for certification generally range from $500 to $3,500, depending on the complexity of the operation. Therefore, AMS expects that most of the accredited certifying agents would qualify as small entities under the SBA criteria. The economic impact on entities affected by this rule would not be significant. The effect of this rule, if implemented as final, would be to allow the use of additional substances in organic crop or livestock production and organic handling. This action would increase regulatory flexibility and would give small entities more tools to use in day-to-day operations. AMS concludes that the economic impact of this addition, if any, would be minimal and beneficial to small agricultural service firms. Accordingly, USDA certifies that this rule would not have a significant economic impact on a substantial number of small entities. B. Executive Order 12988 Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect. Accordingly, to prevent duplicative regulation, states and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or state officials who want to become certifying agents of organic farms or handling operations. A governing state official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA from creating certification programs to certify organic farms or handling operations unless the state programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 6507(b)(2) of the OFPA, a state organic certification program that has been approved by the Secretary may, under certain circumstances, contain additional requirements for the production and handling of agricultural products organically produced in the state and for the certification of organic farm and handling operations located within the state. Such additional requirements must

(a)further the purposes of the OFPA,

(b)not be inconsistent with the OFPA,

(c)not be discriminatory toward agricultural commodities organically produced in other States, and

(d)not be effective until approved by the Secretary. In addition, pursuant to section 6519(c)(6) of the OFPA, this final rule would not supersede or alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 *et seq.* ), nor the authority of the Administrator of the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 *et seq.* ). C. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. D. Executive Order 13175 This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on tribal governments and will not have significant tribal implications. E. Comments Received on Proposed Rule AMS-NOP-17-0080; NOP-17-09 During a 60-day comment period that closed on June 29, 2018, AMS received five comments on proposed rule AMS-NOP-17-0080. These comments were submitted by a certifying agent, a dairy producers' association, an egg producer, a trade association, and a dairy operation. The received comments can be viewed at *https://www.regulations.gov/* by searching for the document AMS-NOP-17-0080. Comments Received on Additions to § 205.603 All comments received by AMS indicated support for the addition of elemental sulfur to § 205.603(b) for use as an external parasiticide to treat organic livestock and poultry for the control of mites, fleas, and ticks when preventive practices are ineffective. The certifying agent's comment noted that elemental sulfur is effective when dusted on or rubbed into the feathers of poultry or hair of livestock and applied to appropriate surfaces of livestock housing. The egg producer stated that elemental sulfur is the only effective substance for removing or repelling mite infestation in cage-free poultry. The dairy operation commented that elemental sulfur works as a repellant to mites, fleas, and ticks that may be vectors of disease that can be transmitted to livestock. The comment from the membership-based trade association supported adding elemental sulfur to the National List for topical pest control since current available alternative topical control substances are limited to specific livestock species, such as dairy, or have limited efficacy in controlling lice or mites. Comments on elemental sulfur did not propose amending the elemental sulfur annotation to further restrict its application when use in organic production. Also, AMS did not receive comments that opposed the addition of elemental sulfur to § 205.603. Comments Received on Amendment to § 205.606 AMS received only one comment on reclassifying potassium acid tartrate, also known as cream of tartar, as a synthetic substance listed in § 205.605 to a nonorganic agricultural substance included in § 205.606. In its comment, the member-based trade association noted that potassium acid tartrate's prior classification as a synthetic nonagricultural substance in § 205.605 was not accurate given that potassium acid tartrate is produced through mechanical and natural processes utilizing hot water, filtering, cooling and precipitation associated with the winemaking process. The trade association also stated that the reclassification of potassium acid tartrate to § 205.606 provides incentive for the development of organic potassium acid tartrate, because organic sources for this substance are currently scarce given the limited production of USDA certified organic wine. AMS Response to Comments AMS agrees with the received comments supporting the addition of elemental sulfur to § 205.603 and the reclassification of potassium acid tartrate for § 205.605 to § 205.606. AMS determined that the addition of elemental sulfur to the National List as a topical livestock treatment and the reassignment of potassium acid tartrate as a non-organic agricultural product met the OFPA substance evaluation criteria. AMS also determined that these amendments to the National List did not supersede other federal regulations. The comments received on the proposal supported the amendments and did not provide any basis for reconsidering the amendments. Consequently, this final rule makes no changes to the respective listings that were described in the proposed rule. On December 27, 2018, AMS published a rule amending §§ 205.603 and 205.606, effective January 28, 2019 (83 FR 66559). Therefore, the amendatory instructions in this final rule have been updated from those set out in the proposed rule that was published April 30, 2018. F. General Notice of Public Rulemaking This final rule reflects recommendations submitted by the NOSB to the Secretary to add one substance to the National List and to reclassify one substance on the National List. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Animals, Archives and records, Imports, Labeling, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. For the reasons set forth in the preamble, 7 CFR part 205, subpart G, is amended as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for 7 CFR part 205 continues to read as follows: Authority: 7 U.S.C. 6501—6522. 2. Amend § 205.603 by redesignating paragraphs (b)(2) through

(10)as (b)(3) through

(11)and adding new paragraph (b)(2) to read as follows: § 205.603 Synthetic substances allowed for use in organic livestock production.

(b)* * *

(2)Elemental sulfur—for treatment of livestock and livestock housing. § 205.605 [Amended] 3. Amend § 205.605(b) by removing “Potassium acid tartrate.” 4. Amend § 205.606 by redesignating paragraphs

(q)through

(v)as

(r)through

(w)and adding new paragraph

(q)to read as follows: § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”

(q)Potassium acid tartrate. Dated: April 25, 2019. Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2019-08700 Filed 4-29-19; 8:45 am]

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