Payton Ramsey, Research Fellow
Elizabeth Rumley, Senior Staff Attorney
The United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) recently released new guidelines addressing the documentation needed to support “animal-raising,” “negative use antibiotic,” and “environment-related” claims appearing on meat and poultry product labeling. The notice of availability—which further discusses the comments and findings which spurred the update—is here.
The guidelines serve as agency guidance. They provide additional information, which can help clarify existing agency rules or educate regulated entities on how best to comply. However, unlike rules or regulations, the guidelines lack the force of law. However, they do provide essential insight into how an agency operates, which is important for companies that rely on agency interactions to make business decisions.
While the U.S. Food and Drug Administration (FDA) oversees most food products, FSIS generally has jurisdiction over meat, poultry, and processed egg products. Under the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA), FSIS is granted the authority to develop and implement regulations requiring that meat and poultry product labels are truthful and not misleading. In order to ensure that product labels are accurate and not misleading, FSIS engages in processes to approve the labels before they enter commerce.
Some labels are “generically approved” by FSIS and do not need to be submitted for specific approval. For example, labels that only include specifically required information are eligible for generic approval. However, a label containing a “special statement or claim,” must be submitted for FSIS approval.
Animal-raising, negative antibiotic use, and environment-related claims are considered special statements and claims. These can include not only outright statements, but also logos, trademarks, and other symbols. Examples of animal-raising claims include “Raised Without Antibiotics,” “Grass-Fed,” and “Free-Range.” Examples of negative antibiotic use claims include “Raised Without Antibiotics” and “No Antibiotics Ever.” Finally, examples of environment-related claims include “Environmentally Responsible” and “Sustainably Raised.” Claims or logos indicating approval by some type of organization, known as “third party certification claims,” also fall into this special statement category. A recent NALC article discussing these claims generally is available here.
FSIS has always evaluated these “special statements or claims” on a case-by-case basis, after reviewing the documentation accompanying the label approval application. Ultimately, FSIS will approve the label if: (1) the documentation provided supports the claim made, (2) the claim is otherwise truthful and not misleading, (3) the claim is prominently and conspicuously displayed on the product label, and (4) the claim does not otherwise cause the product to be misbranded under the FMIA or PPIA.
In 2016, FSIS released a guidance document describing the supporting documentation required when submitting a label including an animal raising claim. In response to the comments received regarding the 2016 guidelines, updated guidelines were released in 2019. Since then, various organizations have requested updates and clarifications to the policy.
For example, FSIS received three petitions for rulemaking from groups asking for specific regulations to be promulgated. The Animal Welfare Institute asked that FSIS define “free range” and implement stricter standards for approval of the claim. Perdue Farms submitted a petition to define “pasture-raised” and distinguish it from “free range.” Finally, People for the Ethical Treatment of Animals (PETA) submitted a petition requesting that FSIS outright stop its review and approval of animal-raising claims. Based on these petitions, along with “askFSIS questions, petitions, interactions with stakeholders, FSIS sampling data, and comments on the previous version,” FSIS created and published the 2024 version.
In the new guidance, where a seller seeks approval for a label containing an animal-raising claim, the seller is strongly encouraged to use a third-party certifier in substantiating the claim. If the label displays the third-party certifier’s name, logo (when the organization has a logo), and website the label will not need to include a further definition of the claim, provided the website provides the definition and any applicable standards. However, if the seller doesn’t utilize a third-party certifier, the label will need to include the name of the entity that established the standard and explain the meaning of the claim for consumers. For example, the seller “ABC Ranch” might include a statement reading “ABC Ranch Defines Humanely Raised as [explanation of meaning].” This is generally true for claims FSIS has not defined.
Further, the guidelines now strongly encourage that label approval applications submitted by sellers for claims like “pasture-raised,” “pasture-fed,” and “meadow-raised” include additional written documentation to substantiate the claim. Generally, the 2019 guidelines recommended that living condition claim applications be accompanied by: (1) a detailed written description explaining that the manner the animals are raised in is consistent with the claim, (2) a signed and dated document portraying that how the animals are raised is not false and misleading under the claim, (3) a written description of the product tracing and segregation mechanisms, and (4) a written description of identification, control, and segregation of any non-conforming animals or products.
The 2024 guidelines include these recommendations, but in addition to recommending third-party certification, now also encourage “pasture raised” or similar claim applications to include further documentation that the majority of each animal’s life was spent on land where the majority is rooted in vegetative cover such as grass or other plants. This requirement for additional documentation suggests that FSIS may be stricter in approving these types of animal-raising claims.
FSIS also updated its guidelines to include recommendations for “negative antibiotic use claims.” The changes to the guidelines were considered in response to a recent research study that found evidence of antibiotic use in beef cattle destined for a “No Antibiotics Ever” program. FSIS and the USDA Agricultural Research Service followed this study with one of their own, where liver and kidney samples of cattle intended for the raised without antibiotics market also showed evidence of antibiotic use.
In response to these findings, the FSIS guidelines now strongly recommend negative antibiotic use claims to be substantiated by routine sampling and testing programs that test for antibiotic use in the animals prior to slaughter. If routine sampling or testing isn’t utilized by the seller, FSIS strongly recommends the use of a third-party certifier that undertakes its own routine testing and sampling. While testing and sampling are not required by the guidelines, it is unclear what additional documentation FSIS might accept in place of sampling and whether sellers lacking a sampling protocol will continue to obtain approval.
Additionally, FSIS updated environment-related claims guidance to strongly encourage sellers to provide additional documentation like environmental data or studies to help ensure claims are truthful and not misleading. As with other claims, sellers seeking approval for their environment-related claim are strongly encouraged to use third-party certifiers. As with the guidelines released for animal-raising claims, this suggests a steeper hurdle for sellers to overcome when submitting labels for approval.
Throughout the guidelines, FSIS encourages sellers to seek third-party certification for their claims. This independent verification can help ensure that claims are truthful and not misleading. However, it is also important to consider the credibility of the organization making the certification. As such, FSIS outlines the way in which it will evaluate each third-party certifier. According to the guidelines, third-party certifiers should be organizations independent of the entity or establishment paying for the certification. Both the certifier and the standards applied should be credible and reliable. Further, the certifier should routinely audit and validate any claims it certifies. The certifier should also employ experienced and knowledge auditors, have written measures protecting against conflicts of interest, and possess the resources needed to fully implement its certification program.
If a third-party certifier is utilized, FSIS will only approve the label bearing the claim 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).
Additional changes to the guidelines included requiring clarifying language such as “used,” “raised,” or “made with” when establishments carry forward an animal-raising claim to a multi-ingredient. FSIS also provided additional guidance on the use of claims like “Vegetarian Fed,” and added a FSIS email which sellers can use when submitting written requests to add new supplier documentation for previously approved product labels.
Comments in response to the new guidelines can be submitted until November 12, 2024, either online or by mail.