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.

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)).

FSIS allows some labels to be generically approved if they bear all applicable mandatory labeling features, 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.

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 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.

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 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.

In March 2023, Perdue Farms, LLC (Perdue) submitted a petition for rulemaking 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.

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 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.

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. 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.

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). 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.

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. 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.

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. 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.

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. 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.

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.

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.

[FR Doc. 2024-19696 Filed 9-9-24; 8:45 am]

BILLING CODE 3410-DM-P