The USDA’s Food Safety and Inspection Service (FSIS) updated its guidance on how to substantiate animal-raising or environment-related claims on meat or poultry product labeling.

The guideline provides recommendations for animal welfare, breed, diet, living or raising conditions, negative antibiotic use, negative hormone use, source and traceability, organic, and environment-related claims.

Specifically, the revised guideline:

• added language to help establishments make animal-raising or environment-related claims on multi-ingredient products;
• separated “Animal Welfare” and “Environmental Stewardship” and renamed “Environmental Stewardship” to “Environment-Related” to better clarify the claims and the documentation recommended for each type of claim;
• added additional examples of common diet claims, such as “Acorn Fed,” “Grain Fed,” and “Corn Fed”;
• clarified “Vegetarian Fed” and “No Animal Byproducts” claims;
• “strongly encouraged” establishments to submit to substantiate living or raising condition claims, such as “Pasture Raised,” “Pasture Fed,” “Pasture Grown,” and “Meadow Raised”;
• recommended establishments using negative antibiotics use claims institute sampling programs themselves or use a third-party certifier that samples for antibiotic residues as part of their certification standards to ensure that negative antibiotics use claims are truthful;
• stated establishments using environment-related claims are “strongly encouraged” to provide FSIS with data or studies to support environment-related claims on their label;
• recommended establishments coordinate with the FSIS Labeling and Program Delivery Staff (LPDS) to discuss the development of environment-related claims and supporting documentation;
• encouraged the use of third-party certification based on the complexity and difficulty to substantiate claims; and
• recommended criteria for third-party organizations that certify animal-raising and environment-related claims.

In addition, throughout the guideline, FSIS added language “to emphasize that it strongly recommends use of a third-party certifying organization to substantiate claims, and that establishments should provide FSIS with a copy of their current third-party certification certificate.” The guideline also emphasized that if a claim was certified by a third-party organization, FSIS 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.

In reviewing the revised guidance, the Animal Welfare Institute (AWI) contended FSIS “should require — not merely ‘strongly encourage’ — companies to use independent third-party certifiers to substantiate claims such as ‘humanely raised,’ ‘pasture raised,’ and ‘raised without antibiotics.’”

“While the revised guidelines are a small step in the right direction, they remain insufficient to combat misleading label claims used to market meat and poultry products,” said Zack Strong, acting director and senior attorney for AWI’s Farmed Animal Program. “The USDA continues to allow companies to essentially make up their own definitions with no repercussions — harming animals, consumers, and higher-welfare farmers.”

AWI noted the revised guideline does “more clearly define ‘pasture raised’” as meaning the majority of an animal’s life was spent on “pasture” (i.e., land mostly “rooted in vegetative cover with grass or other plants”). “However, the FSIS still does not require companies to submit specific documentation demonstrating compliance with the new definition. Instead, the agency only strongly encourages producers to do so,” AWI said.

AWI added that “similarly, companies are only strongly encouraged — not required — to support ‘raised without antibiotics’ claims by instituting their own sampling program to test for antibiotics or using a third-party certifier. “Overall, the updated guidelines continue to allow companies to use their own documentation to substantiate claims instead of using independent third-party certifiers,” AWI said. “The USDA’s updated guidelines are largely meaningless in effecting real change,” Strong concluded.

However, in announcing the revised guideline, Agriculture Secretary Tom Vilsack noted “these updates will help to level the playing field for businesses who are truthfully using these claims and ensure people can trust the labels when they purchase meat and poultry products.”

FSIS said the updated guideline recommendation that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing “were informed by sampling data, petitions, public comments to those petitions and feedback received from a wide range of stakeholders.”

“In light of concerns about negative antibiotic claims, FSIS announced last year that the agency would be conducting a study in partnership with USDA’s Agricultural Research Service (ARS) to assess the veracity of these claims,” the agency said.

FSIS collected liver and kidney samples from 196 eligible cattle at 84 slaughter establishments in 34 states, and ARS analyzed the samples using a method that targeted more than 180 veterinary drugs including various major classes of antibiotics. The study found antibiotic residues in approximately 20 percent of samples tested from the “Raised Without Antibiotics” market.

“The action FSIS is taking through the publishing of this guidance today addresses these concerning findings and makes clear that FSIS will take enforcement action against any establishments found to be making false or misleading negative antibiotic claims,” the agency said.

FSIS said it “informed the establishments with positive results from the ARS-FSIS study and advised them to conduct a root cause analysis and implement corrective actions. FSIS has also advised these establishments to determine how antibiotics were introduced into the animal and to take appropriate measures to ensure that future products are not misbranded.”

FSIS added “the study findings underscore the need for more rigorous substantiation of such claims. These sampling results may lead to additional testing by the agency. FSIS has the authority to collect samples any time it believes a product is mislabeled with any claim covered by the guidance. Moreover, FSIS may consider future additional actions, including random sampling and rulemaking, to further strengthen the substantiation of animal-raising and environment-related claims.”

According to the guideline, establishments must submit labels bearing animal-raising or environment-related claims to LPDS with documentation that substantiates the claims. Typically, the documentation recommended to substantiate such claims includes:

• A written description explaining the controls used for ensuring that the raising claim is valid from birth to slaughter, or the period of raising being referenced by the claim;
• A signed and dated document describing how the animals are raised which may include feed formulations or tags to support that the specific claim made is truthful and not misleading;
• A written description of the product tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution;
• A written description for the identification, control and segregation of nonconforming animals/product;
• A written description, including environmental data or studies, explaining and supporting the meaning of the environment-related claim and the controls used to ensure that the environment-related claim is valid; and
• If a third-party organization certifies a claim, a current annual copy of the certificate from the certifying organization.

The guideline said third-party certification should be performed by an organization independent of the establishment paying for the certification. In addition, the third party certifying the organization and its standards needs to be credible and reliable.

“The organization should routinely audit, validate, and verify claims on the label to ensure they continue to meet related standards,” the guideline said, adding “if applicable, the certifier should also conduct routine sampling and testing to verify relevant claims, such as negative antibiotic use claims.”

Third-party certification programs also should employ auditors who have relevant knowledge and experience to complete a certification and have written measures to protect against conflicts of interest with the entities they are certifying or auditing. “These programs should have the resources necessary to fully implement its certification program and the authority to:

• review any relevant records;
• conduct onsite audits of an eligible entity; and
• suspend or withdraw certification for failure to comply with applicable standards.”

Submit comments by Nov. 12 to Docket No. FSIS-2024-0010 via www.regulations.gov.