USDA publishes updated Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims

Last month, the US Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published an updated Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims.

The updated guideline provides information to establishments on what documentation FSIS reviews when approving voluntary claims related to animal-raising techniques, such as “Raised Without Antibiotics,” “Grass-Fed,” and “Free-Range” and claims related to the environment, such as “Raised Using Regenerative Agriculture Practices” and “Climate-Friendly” when they are used on meat and poultry products.¹ Although positioned as a guidance focused on claims substantiation, the document also provides insight into what types of claims FSIS will accept and how FSIS expects those claims to be phrased.

Background

Animal-raising claims and environment-related claims are becoming increasingly popular on labels and point-of-sale retail labeling. Animal-raising claims can include statements about antibiotic use or hormones, specialty feeds or diets, living or raising conditions, animal welfare, and sourcing or traceability. The following are examples of such claims, in FSIS’s view:

“Raised Without Antibiotics/Hormones”
“Grass/Grain Fed”
“Pasture Raised”
“Cage Free”
“Humanely Raised”
“Source Verified and Traceable to [farm]”
“Organic

FSIS views environment-related claims as encompassing a broad category of claims about environmental stewardship, sustainable farming techniques, and carbon output, such as the following:

“Sustainably Farmed”
“Raised with Environmental Stewardship”
“Raised Using Regenerative Agriculture Practices”
“Carbon Neutral/Zero”
“Reduction of Greenhouse Gases”

All of these types of claims are considered “special statements or claims” requiring prior review and sketch approval by FSIS Labeling and Program Delivery Staff (LPDS). FSIS’s guideline addresses how claims should be phrased (including necessary qualifiers or explanatory text) and what type of information the establishment must include with the label application. The guideline is nonbinding and is intended to explain FSIS’s current thinking on label approvals and claims substantiation.

Updated Guideline

The updated compliance guideline expands on the December 2019 version of the guideline and explains what types of documentation LPDS will require to substantiate various claims.² The key changes in the updated guideline include the following:

Negative Antibiotic Claims: FSIS recommends that claims about the absence of antibiotics (e.g., “Raised Without Antibiotics,” “No Antibiotics Ever”) should be supported by routine sampling and testing programs or through third-party certification by a program that includes a testing component. When submitting the claim for approval, the establishment should include a description of the sampling program and documentation of the test results to FSIS.

FSIS’s Constituent Update announcing the updated guideline highlights that FSIS is particularly concerned with the truthfulness of negative antibiotic claims. FSIS worked with the USDA Agricultural Research Service (ARS) to complete a market study in 2023 that found antibiotic residues in approximately 20% of samples it collected in cattle at slaughter that were intended for the “Raised Without Antibiotics” market.³ The notice states, “FSIS will take enforcement action against any establishments found to be making false or misleading negative antibiotic claims.” FSIS and ARS plan to publish a paper with the results of the study in the near future.

Third Party Certification: FSIS strongly recommends substantiating claims by obtaining third-party certification, where available. The guideline notes that where a third party has certified a claim, the certifying entity’s name, website address, and logo should accompany the claim. Where the standards used to define the claim are available on the third-party certifier’s website, the label need not include a statement that fully explains the claim. When submitting the claim for approval, the establishment should include a copy of the certificate from the certifying organization.

FSIS notes that it will evaluate the specific certification program to assess its suitability for substantiating the specific claim. In particular, the organization should be independent from the establishment paying for the certification and have processes in place to address conflicts of interest with the parties it certifies. It should also have credible and reliable standards, routinely audit and verify claims to ensure they meet the standards, and conduct routine sampling and testing as appropriate (e.g., for negative antibiotic use claims).

Breed Claims: FSIS requires that claims about the specific breed of livestock or poultry (e.g., “Angus Beef,” “Berkshire Pork,” “Muscovy Duck”) generally be substantiated by specified information about the establishment’s breed tracing and product segregation programs. However, the updated guideline notes that establishments using a USDA audit-based program like the Process Verified Program (PVP) may rely on this program to substantiate the claim and need not provide the other breeding program documentation listed in the guideline. Under PVP, an establishment’s program is independently administered, verified, and audited by USDA’s Agricultural Marketing Service (AMS).
Living or Raising Conditions Claims: FSIS expanded on its current information for claims regarding living or raising conditions (e.g., “Pasture Grown,” “Cage/Crate Free,” “Free Range”). Importantly, the guideline notes LPDS will only approve this type of claim if a statement is included on the label explaining the meaning of the claim or if the label provides the URL to a website that explains the claim. For instance, a “Cage Free” claim would need to be accompanied by a statement explaining how the company defines “cage free” or noting that the definition of “cage free” can be found on the company’s website and providing the URL. However, where the claim is substantiated by third-party certification and the third-party certification name, website, and logo are included on the label, this type of clarifying statement is not required.

The updated guideline also notes that animal-raising claims about pasture access (e.g., “Pasture Raised/Grown/Fed,” “Meadow Raised”) should include additional written documentation that the animals are raised on pasture “the majority of their life span from birth until slaughter.” The documentation should also show that the land where the animal was raised is rooted in vegetative cover with grass or other plants (i.e., not a feed lot).

Environment-Related Claims: FSIS moved discussion of environment-related claims to a separate section from animal-raising claims and elaborates on the types of claims that would fall into this category, noted above. Consistent with its policy on other types of claims, FSIS states it strongly encourages environmental data or studies to support environment-related claims and promotes using third-party certification given the difficulty FSIS believes establishments often face when collecting substantiation. The agency also recommends establishments seeking to use environment-related claims seek guidance from LPDS before requesting approval to coordinate on what supporting documentation LPDS will require.

Next Steps

FSIS will accept comments on the updated guideline for 60 days following its publication in the Federal Register. Companies making, or considering making, animal-raising and environment-related claims should review the guideline to identify FSIS’s current thinking on substantiation for such claims and assess their substantiating documentation. We are available to assist with any questions regarding animal-raising and environment-related claims for meat and poultry products and required substantiation.

Authored by Brian D. Eyink and Connie Potter.