Well Done


Law clerk Angela M. Silva contributed to this post.

The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims (Animal-Raising Claims Guideline) discusses the current requirements for substantiating a variety of animal-raising claims (e.g., Raised without Antibiotics, Grass Fed, Raised Without the Use of Hormones). Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products (Animal Ingredient/Feed Claims Guideline) specifically focuses on claims that state bioengineered or genetically modified ingredients or feed were not fed to animals being raised for human consumption (i.e., negative claims).

The Animal-Raising Claims Guideline specifies the various types of supporting documentation that establishments should provide when substantiating certain animal-raising claims on product labels. In general, for most animal-raising claims, FSIS requires at least the first four of the following documents:

  1. A detailed written description explaining the controls used for ensuring that the raising claim is valid from birth to harvest or the period of raising being referenced by the claim
  2. A signed and dated document describing how the animals are raised, which may include feed formulations (e.g., vegetarian fed, raised without antibiotics, grass fed), to support that the specific claim made is truthful and not 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
  4. A written description for the identification, control, and segregation of nonconforming animals/products
  5. If a third party certifies a claim, a current copy of the certificate from the certifying organization

The exact documentation required depends on the specific type of animal-raising claim.  Please refer to the Animal Raising Claims Guideline for additional clarification.

One point to emphasize is that under the Animal-Raising Claims Guideline, third-party certification is optional for establishments to substantiate an array of animal-raising claims. Consequently, if the establishment decides to submit substantiation that does not involve a third-party certifying organization, FSIS must rely exclusively on information, data, and statements from the establishment (and the establishment only) in ensuring that the animal-raising claim is truthful and not misleading.

This contrasts with the updated Animal Ingredient/Feed Claims Guideline, which requires establishments that make specific “negative claims” that (1) bioengineered or genetically modified ingredients were not used in meat, poultry, or egg products, or (2) a product was produced from livestock or poultry that were not fed bioengineered or genetically modified feed to submit the following:

  1. A current copy of a third-party certificate
  2. A written description for the identification, control, and segregation of conforming and nonconforming animals or products, except when these activities are a condition of examples of negative claims for the meat or poultry certification

While the Guidelines will likely be helpful to industry as they provide clear substantiation checklists for many types of label claims, it is important to recognize the distinction that third-party certification is optional for those claims identified in the Animal-Raising Claims Guideline, but is required for claims under the Animal Ingredient/Feed Claims Guideline. FSIS has received some criticism for this distinction and, as these claims continue to proliferate in the marketplace, it will be of interest to see if this important distinction will be sustained in the agency’s review and acceptance process.