Unknown. Notification of availability and request for comments

6,762 words·~31 min read·/register/2024/09/10/2024-19696·

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-2024-09-10.xml --- 89 175 Tuesday, September 10, 2024 Contents Agricultural Marketing Agricultural Marketing Service NOTICES Hearings, Meetings, Proceedings, etc.: Fruit and Vegetable Industry Advisory Committee, 73350-73351 2024-20419 Agricultural Research Agricultural Research Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 73351 2024-20412 Agriculture Agriculture Department See Agricultural Marketing Service See Agricultural Research Service See Food Safety and Inspection Service See Forest Service See National Agricultural Statistics Service Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 73420-73421 2024-20400 Coast Guard Coast Guard RULES Safety Zone: Hurricanes, Tropical Storms, and other Storms with High Winds; Captain of the Port Zone Sector Delaware Bay, 73291-73293 2024-20391 Key West Paddleboard Classic, Key West, FL, 73289-73291 2024-20384 NOTICES Hearings, Meetings, Proceedings, etc.: National Boating Safety Advisory Committee, 73426-73427 2024-20284 Request for Membership Application: National Boating Safety Advisory Committee, 73425-73426 2024-20283 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Consumer Product Consumer Product Safety Commission PROPOSED RULES Revision to the Voluntary Standard for Soft Infant and Toddler Carriers, 73320-73321 2024-20066 NOTICES Filing of Certificate of Compliance Data:

Expansion of Partner Government Agency Message Set Test and Collection of Information Burden Estimate, 73392-73397 2024-20367 Defense Nuclear Defense Nuclear Facilities Safety Board RULES Freedom of Information Act: Revised Fee Schedule, 73258-73260 2024-19527 Energy Department Energy Department See Federal Energy Regulatory Commission PROPOSED RULES Privacy Act; Implementation of Exemptions, 73312-73316 2024-20152 NOTICES Change in Control: Driftwood LNG LLC, 73398-73399 2024-20394 Privacy Act;

Systems of Records, 73399-73402 2024-20376 Environmental Protection Environmental Protection Agency RULES Reclassification of Major Sources as Area Sources under the Clean Air Act, 73293-73308 2024-20074 NOTICES Hearings, Meetings, Proceedings, etc.: 2024 Workshops to Obtain Input on Initial Draft Materials for the Integrated Science Assessment for Oxides of Nitrogen—Health Criteria, 73414-73415 2024-20350 Proposed Consent Decree: Clean Air Act Citizen Suit, 73413-73414 2024-20386 Export Import Export-Import Bank NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Export-Import Bank Letter of Interest Application, 73415 2024-20379 Federal Aviation Federal Aviation Administration RULES Airman Certification Standards and Practical Test Standards for Airmen: Incorporation by Reference; Correction, 73271-73272 2024-20216 Airspace Designations and Reporting Points: Beloit, KS, 73272-73273 2024-20207 Fort Worth, TX, 73273-73274 2024-20209 Airworthiness Directives: Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP);

Bombardier, Inc.) Airplanes, 73262-73264 2024-20307 Airbus Helicopters, 73267-73269 2024-20343 Dassault Aviation Airplanes, 73264-73267 2024-20315 The Boeing Company Airplanes, 73260-73262, 73269-73271 2024-20389 2024-20390 PROPOSED RULES Airworthiness Directives: Airbus SAS Airplanes, 73316-73320 2024-20258 Federal Communications Federal Communications Commission PROPOSED RULES Implications of Artificial Intelligence Technologies on Protecting Consumers from Unwanted Robocalls and Robotexts, 73321-73330 2024-19028 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 73406-73407 2024-20311 Application: Dominion Energy South Carolina, Inc., 73404-73405 2024-20402 Combined Filings, 73402-73409 2024-20309 2024-20404 2024-20406 2024-20411 Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status: Liberty 1 Solar, LLC, Callisto I Energy Center LLC, Goose Prairie Solar LLC, et al., 73407 2024-20409 Filing: Pacific Gas and Electric Co., 73407 2024-20308 Southeastern Power Administration, 73403 2024-20401 Hearings, Meetings, Proceedings, etc.:

Innovations and Efficiencies in Generator Interconnection, et al.; Workshop, 73409-73412 2024-20306 Service of Order to Show Cause: Ketchup Caddy, LLC, Philip Mango, 73412-73413 2024-20410 Federal Highway Federal Highway Administration NOTICES Adoption of Cyber Security Evaluation Tool, 73488-73489 2024-20331 Federal Motor Federal Motor Carrier Safety Administration NOTICES Exemption Application: Commercial Driver's License Standards; State of Hawaii Department of Transportation, 73489-73491 2024-20303 Parts and Accessories Necessary for Safe Operation;

Great Lakes Timber Professionals Association, 73492-73494 2024-20377 Federal Reserve Federal Reserve System NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 73418 2024-20395 Request for Information: Operational Aspects of Federal Reserve Bank Extensions of Discount Window and Intraday Credit, 73415-73418 2024-20418 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Seven Species on the List of Endangered and Threatened Wildlife and Six Species on the List of Endangered and Threatened Plants;

Corrections, 73308-73311 2024-20314 PROPOSED RULES Endangered and Threatened Species: Status for Black Creek Crayfish and Designation of Critical Habitat, 73512-73554 2024-20106 Status for the Alabama Hickorynut and Obovaria cf. unicolor, 73330-73349 2024-20158 Food Safety Food Safety and Inspection Service RULES Guidance: Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims, 73253-73257 2024-19696 Foreign Assets Foreign Assets Control Office NOTICES Sanctions Action, 73497-73501 2024-20280 Forest Forest Service NOTICES Environmental Impact Statements;

Availability, etc.: Ouachita National Forest, Scott and Sebastian Counties, AK, Heavener Coal Leasing Project; Withdrawal, 73353 2024-20341 Hearings, Meetings, Proceedings, etc.: Modoc Resource Advisory Committee, 73351-73352 2024-18414 Proposed Settlement Agreement, Stipulation, Order, and Judgment, etc.: Consent for the Cabin 29/East Area of the Mammoth Stamp Mill Site, Inyo National Forest, Mono County, CA, 73352-73353 2024-20340 General Services General Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Acquisition Regulation; Contract Administration and Quality Assurance, 73418-73419 2024-20387 Government Ethics Government Ethics Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 73419-73420 2024-20352 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See National Institutes of Health Homeland Homeland Security Department See Coast Guard See U.S.

Customs and Border Protection Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: FOIAXpress (FMS2), 73428-73429 2024-20279 Semi-Annual Labor Standards Enforcement Report-Local Contracting Agencies, 73427-73428 2024-20278 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Trust and Estate Income Tax Returns and Related Forms, 73501-73507 2024-20407 International Trade Adm International Trade Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Surveys for User Satisfaction, Impact and Needs, 73357 2024-20345 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Low Speed Personal Transportation Vehicles from the People's Republic of China, 73371 2024-20348 Circular Welded Carbon Steel Standard Pipe and Tube Products from the Republic of Turkiye, Welded Line Pipe from the Republic of Turkiye, etc., 73374-73377 2024-20396 Circular Welded Carbon Steel Standard Pipe and Tube Products from the Republic of Turkiye;

Welded Line Pipe from the Republic of Turkiye; etc., 73361-73364 2024-20397 Ferrosilicon from Brazil, 73371-73374 2024-20363 Ferrosilicon from Malaysia, 73364-73366 2024-20364 Ferrosilicon from the Republic of Kazakhstan, 73369-73371 2024-20365 Mattresses from India, Kosovo, Mexico, and Spain, 73357-73361 2024-20346 Stainless Steel Bar from India, 73367-73369 2024-20399 Sales at Less Than Fair Value; Determinations, Investigations, etc.: Certain High Chrome Cast Iron Grinding Media from India, 73366-73367 2024-20347 International Trade Com International Trade Commission NOTICES Investigations;

Determinations, Modifications, and Rulings, etc.: Certain Aerosol Fire Extinguishing Technology, Components Thereof, and Products Containing Same, 73447 2024-20415 Certain Hydrodermabrasion Systems and Components Thereof, 73446-73447 2024-20417 Certain Icemaking Machines and Components Thereof, 73445-73446 2024-20337 Justice Department Justice Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Census of Public Defender Offices, 73448-73449 2024-20378 Proposed Consent Decree:

CERCLA, 73447-73448 2024-20336 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Proposed Greenlink North Transmission Project in White Pine, Eureka, Lander, Churchill, and Lyon Counties, NV; Proposed Resource Management Plan Amendments, 73429-73431 2024-19544 Maritime Maritime Administration NOTICES Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: Khaleesi (Motor), 73494-73495 2024-20360 Pirate Cat (Sail), 73496-73497 2024-20361 West Wind (Motor), 73495-73496 2024-20359 National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 73353-73356 2024-20403 2024-20405 Charter Amendments, Establishments, Renewals and Terminations: Advisory Committee on Agriculture Statistics, 73354-73355 2024-20408 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.: Center for Scientific Review, 73421-73424 2024-20334 2024-20371 National Center for Advancing Translational Sciences, 73422, 73424-73425 2024-20369 2024-20370 2024-20372 National Institute of General Medical Sciences, 73424 2024-20335 National Institute on Alcohol Abuse and Alcoholism, 73423 2024-20368 National Labor National Labor Relations Board NOTICES Meetings;

Sunshine Act, 73449 2024-20572 National Oceanic National Oceanic and Atmospheric Administration NOTICES Permits; Applications, Issuances, etc.: Marine Mammals; File No. 28223, 73380-73381 2024-20414 Taking of Threatened or Endangered Marine Mammals: Commercial Fishing Operations, 73377-73380 2024-20342 Taking or Importing of Marine Mammals: Ferndale Pier Maintenance Activities in Ferndale, WA, 73381-73392 2024-20392 National Park National Park Service NOTICES Inventory Completion:

California State University, Sacramento, Sacramento, CA, 73433-73434, 73441 2024-20288 2024-20296 Office of the State Archaeologist, University of Iowa, Iowa City, IA, 73437-73438 2024-20281 Tennessee Department of Environment and Conservation Division of Archaeology, Nashville, TN, 73436-73437 2024-20300 U.S. Department of the Interior, Bureau of Land Management, Alaska State Office, Anchorage, AK, 73440 2024-20290 University of Texas at San Antonio, Center for Archaeological Research, San Antonio, TX, 73435-73436 2024-20293 University of Wisconsin Oshkosh, Oshkosh, WI, 73434-73435, 73441-73442, 73444-73445 2024-20287 2024-20298 2024-20301 Western Washington University, Department of Anthropology, Bellingham, WA, 73431, 73438, 73442-73443 2024-20292 2024-20297 2024-20286 National Register of Historic Places:

Pending Nominations and Related Actions, 73433, 73438-73439 2024-20351 2024-20362 Repatriation of Cultural Items: California State University, Sacramento, Sacramento, CA, 73431-73432, 73439 2024-20291 2024-20294 University of Georgia, Laboratory of Archaeology, Athens, GA, 73432, 73443-73444 2024-20289 2024-20295 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Non-Academic Research Internships for Graduate Students Program, 73450-73451 2024-20375 Request for Information:

Merit Review Policy and Processes; Correction, 73450 2024-20318 Nuclear Regulatory Nuclear Regulatory Commission RULES Regulatory Guide: Physical Security Event Notifications, Reports, and Records, 73257-73258 2024-20353 NOTICES Licenses; Exemptions, Applications, Amendments, etc.: North Anna Power Station, Units 1 and 2, Virginia Electric and Power Co.; Record of Decision, 73451-73452 2024-20277 Peace Peace Corps NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 73453 2024-20422 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 73453-73454 2024-20282 Postal Service Postal Service NOTICES International Product Change:

Priority Mail Express International, Priority Mail International and First-Class Package International Service Agreement, 73454 2024-20420 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Days of Prayer and Remembrance (Proc. 10803), 73249-73250 2024-20603 ADMINISTRATIVE ORDERS Ethiopia; Continuation of National Emergency (Notice of September 6, 2024), 73251 2024-20604 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 73465-73466 2024-20366 Self-Regulatory Organizations; Proposed Rule Changes: BOX Exchange, LLC;, 73456 2024-20324 Cboe C2 Exchange, Inc.; Cboe Exchange, Inc.; Cboe BYX Exchange, Inc., et al., 73454-73455 2024-20325 Financial Industry Regulatory Authority, Inc., 73457-73463 2024-20323 Investors' Exchange LLC, 73455 2024-20327 Long-Term Stock Exchange, Inc., 73485-73486 2024-20326 MEMX, LLC, 73456-73457 2024-20328 New York Stock Exchange LLC, 73463-73465 2024-20321 The Nasdaq Stock Market LLC;

Nasdaq BX, Inc.; Nasdaq GEMX, LLC; et al., 73455-73456 2024-20322 The Options Clearing Corp., 73466-73485 2024-20329 Small Business Small Business Administration NOTICES Disaster Declaration: Florida, 73486 2024-20354 Florida; Public Assistance Only, 73486 2024-20355 State Department State Department NOTICES Certification Pursuant to the Department of State, Foreign Operations, and Related Program Appropriations Act, 2024 with respect to Gabon, 73487 2024-20313 Certification Pursuant to the Department of State, Foreign Operations, and Related Programs Appropriations Act, 73488 2024-20317 Culturally Significant Objects Imported for Exhibition:

Kingdom of David and Solomon Discovered, 73487-73488 2024-20304 Manet: A Model Family, 73487 2024-20382 Tacita Dean: Blind Folly, 73486-73487 2024-20305 Wifredo Lam, 73487 2024-20383 Surface Transportation Surface Transportation Board NOTICES Hearings, Meetings, Proceedings, etc.: Rail Energy Transportation Advisory Committee, 73488 2024-20332 Performance Review Board and Executive Resources Board Members, 73488 2024-20374 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Maritime Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service RULES Emergency Import Restrictions:

Categories of Archaeological and Ethnological Material of Ukraine, 73280-73289 2024-20385 Import Restrictions: Archaeological and Ethnological Material of Yemen, 73274-73280 2024-20388 Customs U.S. Customs and Border Protection RULES Emergency Import Restrictions: Categories of Archaeological and Ethnological Material of Ukraine, 73280-73289 2024-20385 Import Restrictions: Archaeological and Ethnological Material of Yemen, 73274-73280 2024-20388 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Application for Cash Surrender or Policy Loan, 73507-73508 2024-20316 Claim for One Sum Payment Government Life Insurance, Claim for Monthly Payments Government Life Insurance, and Claim for One Sum Payment Government Life Insurance (DocuSign), 73508-73509 2024-20356 Industry Standard Forms for Completing an Appraisal Required by VA, 73508 2024-20320 Information for Veteran Readiness and Employment Entitlement Determination, 73509 2024-20302 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 73512-73554 2024-20106 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. 89 175 Tuesday, September 10, 2024 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317, 381, and 412 [Docket No. FSIS-2024-0010] Availability of FSIS Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims AGENCY:

Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA). ACTION: Notification of availability and request for comments. SUMMARY: FSIS is announcing the availability of an updated version of its guideline on documentation needed to support animal-raising or environment-related claims on meat or poultry product labeling. Official establishments submit this documentation to the Agency when they apply for approval of labels with animal-raising or environment-related claims.

The updated guideline includes changes made in response to updated scientific information, FSIS sampling data, askFSIS questions, public comments, petitions, and other meetings with Agency stakeholders. DATES: Submit comments on or before November 12, 2024. ADDRESSES: FSIS invites interested persons to submit comments on this **Federal Register** document. Submit comments by one of the following methods: • *Federal eRulemaking Portal:* This website allows commenters to type short comments directly into the comment field on the web page or to attach a file for lengthier comments.

Go to *https://www.regulations.gov.* Follow the online instructions at that site for submitting comments. • *Mail:* Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700. • *Hand- or courier-delivered submittals:* Deliver to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. *Instructions:* All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2024-0010.

Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to *https://www.regulations.gov.* *Docket:* For access to background documents or comments received, call 202-720-5046 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Washington, DC 20250-3700. FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development;

Telephone:

(202)205-0495. SUPPLEMENTARY INFORMATION: Background Under the Federal Meat Inspection Act and Poultry Products Inspection Act (21 U.S.C. 601-695, at 601(n), 607; 21 U.S.C. 451-470, at 453(h), 457) (the Acts), FSIS develops and implements regulations to require that the labels of meat and poultry products are truthful and not misleading. Under the Acts, the Secretary of Agriculture, who has delegated this authority to FSIS, must approve the labels of meat and poultry products before the products can enter commerce (21 U.S.C. 601(d); 21 U.S.C. 457(c)). 1 1 FSIS has similar authority over egg products under the Egg Products Inspection Act, 21 U.S.C. 1036(b). FSIS allows some labels to be generically approved if they bear all applicable mandatory labeling features, 2 do not contain special statements or claims as defined at 9 CFR 412.1(e)(1), and otherwise comply with the Agency's labeling regulations (see 9 CFR 412.2). Generically approved labels do not need to be submitted to FSIS for approval before they can be used on products in commerce. However, a label with a special statement or claim (9 CFR 412.1(c)(3) and (e)) must be submitted to FSIS for approval before it may be used on a product distributed in commerce. 2 Mandatory labeling features include the product name, handling statement, ingredients statement, name and place of business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition labeling. Animal-raising and environment-related claims are voluntary “special statements and claims” (9 CFR 412.1(e)). Special statements and claims are statements, claims, logos, trademarks, and other symbols as defined in 9 CFR 412.1(e). Special statements and claims include those claims not defined in the Federal meat and poultry products inspection regulations or the Food Standards and Labeling Policy Book; “Natural” claims; health claims; ingredient and processing method claims; structure-function claims; claims regarding the raising of animals ( *e.g.,* “no antibiotics administered”; products labeled as organic; and instructional or disclaimer statements concerning pathogens). FSIS does not require such claims to appear on product labels. However, establishments may voluntarily add animal-raising or environment-related claims to their labels if they do not render the product misbranded. Examples of animal-raising claims include but are not limited to: “Raised Without Antibiotics,” “Grass Fed,” “Free-Range,” and “Raised Without the Use of Hormones.” Examples of environment-related claims include but are not limited to: “Raised using Regenerative Agriculture Practices,” and “Environmentally Responsible.” FSIS evaluates labels bearing such claims on a case-by-case basis by reviewing the animal production protocol submitted with the label approval application. FSIS approves the label if the documentation supports the claim made, if the claim is otherwise truthful and not misleading, if the claim (including any qualifying information) is prominently and conspicuously displayed on the label, and if the claim does not otherwise render the product misbranded under the Acts. At establishments that label products with animal-raising or environment-related claims, FSIS inspectors routinely verify that establishments maintain compliant label records on file. In addition, inspectors may also take appropriate regulatory control action, such as product retention, when they identify misbranded product. FSIS could also rescind approval of false or misleading labels per 9 CFR 500.8. On October 5, 2016, FSIS announced the availability of and requested comments on its “Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submission” (81 FR 68933). FSIS published the guideline to advise establishments on the type of documentation they should submit to support animal-raising claims on meat or poultry product labels. FSIS uses this documentation to determine whether these claims are truthful and not misleading. On December 27, 2019, FSIS announced the availability of an updated version of the guideline (84 FR 71359). FSIS updated the guideline in response to public comments on the 2016 version and a petition for rulemaking. In the 2019 **Federal Register** notification, FSIS specifically requested comments on the label claim “free range” for poultry products in response to the petition. The comments and FSIS' responses are summarized below. After reviewing updated scientific information, FSIS sampling data, askFSIS questions, public comments, petitions, and other meetings with Agency stakeholders, FSIS has revised the guideline to improve readability, better assist establishments with substantiating animal-raising or environment-related claims, and reduce consumer confusion regarding such claims. As discussed below, FSIS strongly encourages the use of third-party certification to substantiate animal-raising or environment-related claims, given the limits of FSIS jurisdiction. Third-party certification of animal-raising or environment-related claims helps ensure that such claims are truthful and not misleading by having an independent organization verify that standards are being met on the farm for the raising of animals and the use of environmentally supportive practices. This guidance document identifies criteria that ensures a third-party certification organization is credible and reliable. The Agency evaluates each third-party certification program to assess its suitability for substantiating these types of claims. The revised guideline is posted at *https://www.fsis.usda.gov/policy/fsis-guidelines.* FSIS Responses to Comments on the 2019 Guideline, Petitions, and Other Information Free Range and Pasture-Raised Claims FSIS received over nine thousand comments in response to the previous guideline from individuals, animal advocacy groups, and industry groups on the previous version of this guideline that argued that living or raising conditions claims ( *e.g.,* “free range” and “pasture-raised”) could be considered misleading because they do not always match consumer expectations. Many commenters suggested that to avoid being considered misleading and to better align with consumer expectations, FSIS should define these claims. Lastly, many of the commenters stated that claims like “free range” should not be considered synonymous with other claims ( *i.e.,* “free-roaming,” “pasture-fed,” “pasture grown,” “pasture-raised,” and “meadow raised”). Many commenters argued that the production practices associated with these claims are fundamentally different and have different animal welfare implications. FSIS also received three petitions for rulemaking requesting changes to the Agency's guidance on animal-raising claims. In January 2016, the Animal Welfare Institute

(AWI)submitted a petition for rulemaking 3 requesting that FSIS amend its poultry products labeling regulations to define “free range” and to establish substantiation requirements for approval of the claim. The petition specifically asked that FSIS prescribe standards for “free range” claims to require that the birds are provided with

(1)outdoor access during daylight hours daily for at least 51 percent of their lives;

(2)outdoor space where at least half of the area has a vegetative cover;

(3)multiple, large access points to the outdoors; and

(4)natural or artificial shelter in the outdoor area. The petition also requested that FSIS require that applications for “free range,” “free-roaming,” and “range grown” labels include a signed affidavit accompanied by a detailed animal care protocol and photographs that illustrate that the birds were raised under conditions that qualify for a “free range,” “free-roaming,” or “range grown” claim. 3 See *https://www.fsis.usda.gov/federal-register/petitions/petition-define-free-range-and-equivalent-terms-use-labeling-poultry.* AWI argued that improperly labeled products could enter the market because FSIS does not define “free range” and its synonymous terms. AWI claimed that the free-range claim can be used in false and misleading ways that may be injurious to individual consumers and the broader market for properly packaged poultry products. The petition included 23 exhibits, consumer expectation data, askFSIS questions, and “free-range” labels approved by FSIS that AWI believed should not have been approved. In December 2019, FSIS issued an interim response to the petition 4 explaining that it updated the guideline to add information on the types of documentation typically needed to substantiate a “free range” claim on a poultry product. FSIS also explained that it requested comments on the Agency's approach for approving “free range” claims in the labeling of poultry products in the 2019 **Federal Register** notification accompanying the updated guideline. 4 See: *https://www.fsis.usda.gov/sites/default/files/media_file/2020-08/16-01-response-123019.pdf.* In March 2023, Perdue Farms, LLC (Perdue) submitted a petition for rulemaking 5 requesting that FSIS remove “pasture-raised” as a claim synonymous with “free range.” Perdue's petition also requested that FSIS define “pasture-raised” to apply only to chickens that spend the majority of their lives physically on “pasture,” and “pasture” as a majority of rooted-in-soil vegetative cover. 5 See *https://www.fsis.usda.gov/policy/petitions/petition-submitted-perdue-farms-llc.* Perdue's petition argued that consumers and industry actors perceive “pasture-raised” and “free range” as separate classifications, with the former as a more premium claim. In addition, the petition argued that making these changes would avoid false and misleading marketing of “free range” chickens that have only access to the outdoors and “pasture-raised” chickens that physically spend their life on a pasture. The petition contained consumer survey data to support their arguments. FSIS received 15 comments from third-party certifying organizations, establishments, industry groups, consumer groups, and members of Congress in support of the petition. Additionally, in July 2022, the People for the Ethical Treatment of Animals

(PETA)submitted a petition for rulemaking 6 requesting that FSIS stop its review and approval of animal-raising claims on food products. Specifically, PETA requested that FSIS amend 9 CFR 412.1 to no longer allow for approval of claims regarding the raising of animals on product labels. PETA also asked FSIS to rescind its guidelines regarding FSIS' approval of animal-raising claims on labels. 6 See: *https://www.fsis.usda.gov/policy/petitions/petition-submitted-people-ethical-treatment-animals.* PETA argued that FSIS lacks jurisdiction to regulate on-farm, animal-raising activities; therefore, FSIS' review, approval, and allowance of animal-raising labels exceeds its statutory authority. According to PETA, because FSIS does not have on-farm jurisdiction, establishments can make misleading or false claims concerning how animals are raised, leading to consumer confusion. The petition included examples of what PETA argued were misleading animal-raising claims that FSIS approved. FSIS didn't receive any public comments on the petition. FSIS' Response FSIS has updated its animal-raising claims guidance in response to the concerns raised by commenters and petitioners. FSIS has, however, determined not to codify in its regulations any specific animal-raising claims definitions at this time. 7 FSIS maintains that animal production practices vary and are continuously developing and that keeping a current list of codified allowable labeling claims would be impractical. 7 The Office of the Federal Register has published this document under the category “Rules and Regulations” pursuant to 1 CFR 5.9(b). The categorization is solely for purposes of publication in the **Federal Register** and does not change the nature of the document and is not intended to affect the validity, content, or intent of the document. See 1 CFR 5.1(c). Codifying definitions for animal-raising claims could also hinder the development of new or improved animal production practices. Producers consistently innovate practices to improve the raising of livestock or poultry from birth to slaughter. Likewise, consumer expectations of animal-raising claims consistently evolve. If animal-raising claims are codified, producers that improve their animal-raising practices could lose the benefit of making certain claims, even if the improved practices better align with changing consumer expectations for such claims. For example, producer and consumer understanding of the animal welfare claim “humanely raised” have changed over time. Continued changes in on-farm practices, animal care prior to slaughter, and evolving consumer expectations mean that the understanding of this claim will continue to evolve in the future. Codifying such claims could, therefore, stifle innovation. Under FSIS' current policy, FSIS Labeling and Program Delivery Staff

(LPDS)generally only approves animal welfare or living or raising conditions claims if establishments define their animal welfare or living conditions claims directly on the label. Alternatively, if the establishment has a website where the claim is defined, it may provide the website address on the label rather than directly define the claim. Also under current policy, for poultry products, establishments do not need to include additional explanation for the living or raising conditions claims “Free Range,” “Free Roaming,” “Pasture Fed,” “Pasture Grown,” “Pasture Raised,” or “Meadow Raised” on the product labels. However, establishments must provide specific documentation to substantiate such claims. This policy helps ensure that consumers are not confused or misled by such claims. FSIS has updated the guidance to strongly encourage the use of third-party certifiers to substantiate animal-raising claims. As stated in the revised guideline, labels that truthfully display a third-party certifier's name, logo, and website do not need to further define their certified animal-raising claims on the product label as discussed above, provided that an explanation of the claim and the relevant standards and definitions are clearly posted on the certifier's website. Additionally, the guideline now strongly encourages establishments to provide additional documentation to the LPDS to substantiate label claims like “pasture-raised,” “pasture-fed,” “pasture grown,” and “meadow-raised.” Specifically, FSIS encourages establishments to provide written documentation describing that animals are raised on pasture, *i.e.,* land where the majority is rooted in vegetative cover with grass or other plants, for the majority of their life span from birth until slaughter. FSIS is not revising the guideline or its regulations to require applications for “free range,” “free-roaming,” and “range grown” labels to include a signed affidavit, accompanied by a detailed animal care protocol and photographs that illustrate that the birds were raised under conditions that qualify for a “free range,” “free-roaming,” or “range grown” claim. To substantiate an animal-raising claim, establishments provide LPDS with documentation that supports the claim. The kind and amount of supporting documentation depends on the claim and could vary according to circumstances. For example, an establishment would need to submit the following documentation to substantiate a “cage free” labeling claim for LPDS approval:

(1)A detailed written description explaining controls for ensuring that the animals are raised in a manner consistent with the meaning of the living or raising conditions claim that is valid from birth to slaughter or the period of raising being referenced by the claim;

(2)A signed and dated document describing how the animals are raised to support that the claims are not false or misleading;

(3)A written description of the product tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution; and

(4)A written description of the identification, control, and segregation of non-conforming animals/product. FSIS comprehensively evaluates these label applications on a case-by-case basis. FSIS will continue to evaluate animal-raising claims and approve labeling that complies with the Acts. Stopping FSIS review and approval of all animal-raising claims, as suggested by one petitioner, would effectively prohibit the display of such claims, including those that are truthful and not misleading. This action would, therefore, raise significant free speech issues and could be considered unconstitutional. Negative Antibiotic Use Claims In April 2022, *Science* magazine published an article entitled “Policy Reform for antibiotic use claims in livestock,” co-authored by the Antibiotic Resistance Action Center at the George Washington University

(GWU)School of Public Health and Food In-Depth (FoodID). 8 The article reported on a study, where the urine of beef cattle designated for the raised without antibiotics market, specifically for a “No Antibiotics Ever” program, was tested for 17 antibiotics commonly administered in feed and water using the FoodID rapid immunoassay. According to the article, the study showed that 15 percent of the cattle feedlots sampled had one or more positive result. A subset of the urine samples that screened positive were subsequently tested in a third-party reference lab. Drug residues were confirmed and quantified in 24 of the 26 samples. 8 Lance B. Price *et al.,* Policy reforms for antibiotic use claims in livestock. Science 376, 130-132 (2022). DOI: 11.1126/science.abj1823. In June 2023, USDA announced that it would be implementing a multi-step effort aimed at strengthening the substantiation of animal-raising and environment-related claims. 9 FSIS and the Agricultural Research Service

(ARS)announced that the two Agencies would be conducting a sampling project to assess antibiotic residues in cattle destined for the raised without antibiotics market. 9 See: *https://www.usda.gov/media/press-releases/2023/06/14/usda-launches-effort-strengthen-substantiation-animal-raising.* In September 2023, FSIS and ARS announced that the Agencies began exploratory sampling to assess whether antibiotics residues are detected in cattle intended for the raised without antibiotics market. 10 FSIS collected liver and kidney samples from 189 eligible cattle at 79 slaughter establishments in 34 States, and ARS analyzed the samples using a method that targeted more than 180 veterinary drugs from various major classes of antibiotics. For the majority (74%) of these drugs, the method used by ARS is capable of detecting the drug at levels as low as 1 part per billion

(ppb)in the animal tissue, with almost all drugs (95%) being detectable at or below 10 ppb. 10 See: *https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-september-22-2023.* The exploratory sampling study found residues of antibiotic drugs in the liver or kidney of 37 raised without antibiotics cattle (equivalent to 20% of the total number of animals sampled) originating from 27 slaughter establishments. There were 46 residue detections in these 37 animals. Residues from 10 different types of drugs were detected (tulathromycin, monensin, chlortetracycline, oxytetracycline, tetracycline, penicillin, tildipirosin, tilmicosin, gamithromycin, and sulfamethazine). FSIS sent letters to establishments where antibiotic residues were found in cattle during the study. The letters notified the establishments about the positive test results, noted that the establishments may have produced misbranded products, and recommended that the establishments take actions to prevent further misbranded product from entering commerce. FSIS also notified the establishments that the results from the study would inform future policy changes, and that the Agency may elect to collect and analyze future samples that could be used to take a regulatory action. FSIS is still considering these issues and will inform the public of any future changes to label policy or Agency sampling. FSIS' Response In response to the *GWU/FoodID* study in *Science* magazine and the FSIS/ARS sampling program results, FSIS has updated its recommendations in the guideline on how establishments substantiate negative antibiotic use claims. Specifically, the guideline now strongly encourages meat and poultry establishments to substantiate such claims by implementing a routine sampling and testing program to test for the use of antibiotics in animals prior to slaughter. In the alternative, the guideline strongly encourages that establishments obtain third party certification for negative antibiotic use claims from certifiers that routinely perform antibiotic sampling and testing as a condition of certification. Environment-Related Claims The Environmental Working Group

(EWG)submitted petitions for rulemaking in April and July 2023. 11 EWG requested that FSIS:

(1)reject climate-related and environment-related labeling claims like “low-carbon beef” and “climate-friendly” made directly by establishments,

(2)require third-party certification for climate claims, and

(3)require a numerical carbon disclosure whenever such claims are made. 11 See *https://www.fsis.usda.gov/policy/petitions/petition-submitted-environmental-working-group.* EWG argued that many environmental welfare climate claims ( *e.g.,* Low-Carbon Beef, Net-Zero, Carbon Neutral, Carbon Negative, Climate Neutral, Net-Zero Carbon, Climate Positive, Climate Neutral, and Carbon Positive) are inherently misleading. According to EWG, most consumers believe these claims reflect reductions in actual greenhouse gas emissions in-house, not offsets of these emissions through changes in farming practices by others. The petitioner stated that when consumers are told that claims could be made by reliance on offsets instead of actual emissions reductions, most consumers report feeling misled. 12 12 See *https://www.asa.org.uk/static/6830187f-cc56-4433-b53a4ab0fa8770fc/CCE-Consumer-Understanding-Research-2022Final-090922.pdf.* FSIS' Response In response to this petition, FSIS has updated the guideline to explain that establishments are strongly encouraged to provide additional documentation, such as environmental data or studies, to FSIS to support and substantiate their environment-related claims. This change to the environment-related claims guidance will help ensure that claims are truthful and not misleading. FSIS recommends that establishments contact LPDS to discuss potential environment-related claims and the documentation needed to support such claims before submitting a label application for prior approval. Under FSIS' current policy, establishments define their environment-related claims directly on the label. Alternatively, if the establishment has a website where the claim is defined, it may provide the website address (where the relevant standards are posted) on the label rather than directly define the claim. This policy helps ensure that consumers are not confused or misled by such claims. FSIS also updated the guideline to strongly encourage establishments using environment-related claims to use third-party certifiers. When label claims are certified by a third-party organization, which posts the standards used to define the claim conspicuously on its website, establishments do not need to include statements that fully explain their claims on their labels. Third Party Certification FSIS' guideline now strongly encourages establishments to use a third-party organization to substantiate animal-raising or environment-related claims. For example, FSIS recommends that third party certification should be performed by an organization independent of the establishment paying for the certification, that the third-party organization should routinely audit, validate, and verify claims on the label to ensure they meet related standards. Moreover, FSIS recommends that the third-party certifier conducts testing for raised without antibiotics claims. In response to concerns that third-party certification is costly for small and very small establishments, FSIS is exploring options to determine whether there are lower-cost third-party certification programs, including those offered by the Agricultural Marketing Service (AMS), that meet the recommended criteria for third-party certifiers included in the revised guideline. Summary of Changes to the Guideline FSIS made the following minor changes to the guideline in response to askFSIS questions and meetings with stakeholders: • FSIS clarified that when establishments carry forward an animal-raising claim to a multi-ingredient product, the claim needs to include qualifying language such as “used,” “raised,” or “made with” to make clear that the animal-raising claim is specific to the meat or poultry component in the multi-ingredient product. • FSIS added examples of common diet claims and added further guidance on the use of “Vegetarian Fed” and “No Animal Byproducts” claims to clarify that these claims mean that animals are solely fed plant-based feeds and no animal products. • FSIS created a new email address for establishments to use when submitting requests to add new supplier documentation for a previously approved label without having to resubmit the label for another sketch approval. • FSIS separated “Animal Welfare” and “Environmental Stewardship” sections and renamed “Environmental Stewardship” to “Environment-Related” to better clarify the claims and the documentation to be submitted for each type of claim. • FSIS made several changes to the formatting, language, and organizational structure of the guideline to improve readability. As explained above, FSIS also made some significant changes to the guideline in response to petitions and public comments on the last version of the guideline. • FSIS updated documentation that establishments are strongly encouraged to submit to LPDS to substantiate claims like “Pasture Raised,” “Pasture Fed,” “Pasture Grown,” and “Meadow Raised.” • FSIS recommended criteria for third-party organizations that certify animal-raising or environment-related claims. • FSIS further emphasized that, to substantiate a third-party certification claim, establishments should provide FSIS with a copy of their current certificate. • FSIS further emphasized that if a claim was certified by a third-party organization, the Agency will approve the label bearing the claim only if it includes the certifying entity's name, website address (where the relevant standards can be found), and logo, when the organization has a logo. • FSIS added language strongly encouraging establishments to substantiate negative antibiotic use claims by instituting a routine sampling program to test for the use of antibiotics in animals prior to slaughter or by using a third-party certifier who performs routine antibiotic sampling and testing as part of their certification standards. • FSIS added language stating that establishments are strongly encouraged to provide FSIS with relevant data or studies ( *e.g.,* soil/land variation or air quality studies and results) to substantiate environment-related claims. • FSIS added language strongly encouraging establishments to use third-party certification to substantiate animal-raising or environment-related claims, given the limits of FSIS jurisdiction. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this **Federal Register** publication online through the FSIS web page located at *http://www.fsis.usda.gov/federal-register.* FSIS will also make copies of this publication available through the FSIS *Constituent Update,* which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The *Constituent Update* is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service that provides automatic and customized access to selected food safety news and information. This service is available at: *https://www.fsis.usda.gov/subscribe.* Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password-protect their accounts. USDA Non-Discrimination Statement In accordance with Federal civil rights law and U.S. Department of Agriculture

(USDA)civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident. Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information ( *e.g.,* Braille, large print, audiotape, American Sign Language) should contact the responsible Mission Area, agency, or staff office; the USDA TARGET Center at

(202)720-2600 (voice and TTY); or the Federal Relay Service at

(800)877-8339. To file a program discrimination complaint, a complainant should complete Form AD-3027, *USDA Program Discrimination Complaint Form,* which can be obtained online at *https://www.usda.gov/forms/electronic-forms,* from any USDA office, by calling

(866)632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant's name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights

(ASCR)about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

(1)*Mail:* U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; or

(2)*Fax:*

(833)256-1665 or

(202)690-7442; or

(3)*Email: program.intake@usda.gov.* USDA is an equal opportunity provider, employer, and lender. Done at Washington, DC. Paul Kiecker, Administrator. [FR Doc. 2024-19696 Filed 9-9-24; 8:45 am]

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