USDA-FSIS Updates Substantiation Guideline for Animal-Raising and Environment-Related Claims

On August 28, 2024, USDA’s Food Safety and Inspection Service (FSIS) released an updated Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims for meat and poultry product labeling. Animal-raising and environment-related claims must be reviewed by FSIS before a meat or poultry product bearing such claims may be sold, offered for sale, or otherwise distributed in interstate commerce. FSIS explains that this nonbinding, updated Guideline builds on the significant work the agency has undertaken to date to protect consumers from false and misleading labels and to implement President Biden’s Executive Order on Promoting Competition in the American Economy.

FSIS Regulatory Framework

FSIS derives its legal authority to oversee the labeling of meat and poultry products from the Federal Meat Inspection Act and the Poultry Products Inspection Act. Under the FSIS framework (and unlike the FDA’s food regulatory framework), FSIS implements a “prior approval” review program for labels intended to be used on federally inspected meat and poultry products. FSIS approves labels through two pathways: (1) the sketch approval process and (2) generic label approval.

Labels subject to sketch approval must be submitted to FSIS for review and approval before use and include labels containing special statements and claims, such as animal-raising claims. From a FSIS perspective, animal-raising claims (such as “Raised Without Antibiotics,” “Grass-Fed,” and “Free-Range”) and environment-related claims (such as “Raised using Regenerative Agriculture Practices” and “Climate-Friendly”) are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices. FSIS reviews the documentation submitted by companies to support these claims, and the claims can only be lawfully included on the labels of meat and poultry products sold to consumers after they are approved by FSIS.

The Guideline in a Nutshell

This Guideline, last updated in 2019, provides information on how to substantiate animal-raising or environment-related claims displayed on meat or poultry product labels. It provides general recommendations on how to substantiate such claims and provides specific guidance with regard to:

• Animal welfare claims.
• Breed claims.
• Diet claims.
• Living or raising conditions claims.
• Negative antibiotic use claims.
• Negative hormone use claims.
• Source and traceability claims. 
• Organic claims.
• Environment-related claims.

Notable Updates to the 2024 Guideline

In the updated Guideline, FSIS:

• Separates “Animal Welfare” and “Environmental Stewardship” into two sections and renames “Environmental Stewardship” to “Environment-Related” to further clarify the claims and the documentation recommended.
• Strongly encourages the use of third-party certification and more robust documentation to substantiate animal-raising and environment-related claims and recommends that establishments provide FSIS with a copy of their current third-party certification certificate.
• Emphasizes 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).
• Recommends 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. 
• Adds examples of common diet claims, such as “Acorn Fed,” “Grain Fed,” and “Corn Fed.”

For environment-related claims, in particular, FSIS has added language: 

• Stating that establishments are strongly encouraged to provide FSIS with data or studies to support environment-related claims on their label. 
• Recommending that establishments coordinate with the FSIS Labeling and Program Delivery Staff (LPDS) to discuss the development of environment-related claims and supporting documentation. 
• Encouraging the use of third-party certification based on the complexity and difficulty of substantiating these claims.

Practical Impact for Industry

The updated Guideline reflects FSIS’ current thinking regarding substantiation requirements for animal-raising and environment-related claims and reflects FSIS’ review and accounting of FSIS sampling data, askFSIS questions, public comments, petitions, meetings with FSIS stakeholders, and scientific information. The Guideline is not binding and does not have the force of law. Nevertheless, it is a useful guidepost to facilitate streamlined label reviews for meat and poultry labels bearing animal-raising and environment-related claims. 

FSIS specifically notes in the updated Guideline that the agency has authority to collect meat and poultry samples “any time it believes a product is mislabeled with any claim covered by the guidance” and points out that “FSIS may consider future additional actions, including random sampling and rulemaking, to further strengthen the substantiation of animal-raising and environment-related claims.”

FSIS will accept comments for 60 days following publication of the updated Guideline in the Federal Register.

If you have any questions concerning the material discussed in this Update or wish to prepare comments, please contact the authors.