Revising the “Product of the USA” standard for meat and poultry products has been a long-running priority for the Biden Administration.1 FSIS explains the new proposed rule, entitled “Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims” (the “Proposed Rule”),2 is necessary to “resolve consumer confusion” around U.S.-origin claims, as reflected in a consumer-perception study that FSIS commissioned.3 The agency has also received three petitions since 2018 requesting changes to the requirements for “Product of USA” label claims.4
Proposed Requirements for “Made in USA” Claims
The Proposed Rule would limit “Product of USA” or “Made in USA” claims to products for which:
- The meat, poultry, and egg components are derived from animals born, raised, slaughtered, and processed in the United States, and
- Other ingredients in multi-component products (e.g., FDA-regulated ingredients) are of “domestic origin,” except for spices and flavorings.
In its discussion of the Proposed Rule, FSIS describes “domestic origin” as meaning “all preparation and processing steps of the ingredient are completed in the United States.”
The Proposed Rule would also allow manufacturers to make more focused, voluntary, qualified claims regarding U.S.-origin components of a product, so long as the claims are qualified to include a description of how the claim compares to the requirements for an unqualified “Product of USA” claim, including a description of all preparation and processing steps forming the basis for the claim that occurred in the United States. For example, the proposal notes a qualified claim such as “sliced and packaged in the United States using imported pork” would be appropriate. The proposal also notes that a claim referring to product origin in a U.S. state or region (e.g., “Made in North Carolina”) would need to meet comparable requirements: the meat or poultry component would have to be from animals born, raised, harvested, and processed in the state or region, or be appropriately qualified (e.g., “Packaged in Michigan”). For these qualified U.S.-origin claims, the qualifying language must be at least one third the size of the largest letter in the U.S.-origin claim and must be positioned near the claim.
FSIS’s current policy permits “Product of USA” claims on products that are “processed in the U.S.,” regardless of the origin of the meat-producing animals.5 The Proposed Rule would restrict the scope of products eligible for this claim, and it would more closely align FSIS’s policy for “Made in the USA” claims with the Federal Trade Commission’s policy, which is applied to FDA-regulated foods and other consumer products.
Although the Proposed Rule incorporates concepts from the Agricultural Marketing Service’s (AMS’s) Country of Origin Labeling (COOL) regulations, which require disclosing at retail information regarding the origin of certain covered commodities,6 FSIS’s proposal is distinct. FSIS’s Proposed Rule would apply only to voluntary “Product of USA” or “Made in USA” claims, and it introduces the additional concept of the country in which the meat or poultry component was processed; FSIS-regulated products also subject to AMS COOL would still need to comply with AMS requirements as well. FSIS further explains in its preamble discussion to the proposal that, for FSIS-regulated products subject to mandatory AMS COOL, a voluntary U.S.-origin label claim must follow AMS COOL requirements for identifying the country of origin, including where applicable identifying which production steps occur in which countries.
Under the proposal, the “Product of USA,” “Made in USA,” and modified origin claims would remain eligible for generic label approval, meaning they would not need to be pre-approved by FSIS before being used on regulated meat and poultry products.
The Proposed Rule does not change mandatory country of origin claims that foreign countries might require be applied to labels of U.S. products for export. FSIS indicates it will continue to look to its Export Library requirements for mandatory origin marking for exported products.
FSIS has requested comments on various aspects of its proposal, including whether to allow or require third-party certifications for voluntary U.S.-origin claims.
The proposed rule would require establishments to maintain written documentation supporting the U.S.-origin claim. The proposal does not require any specific documentation, but lists as “[e]xamples of the types of documents that may be maintained”:
- A written description of the controls used in the birthing, raising, harvesting, and processing of the source animals and the preparation and processing of other FDA-regulated ingredients;
- A written description of the controls used to trace and segregate source animals and other ingredients through the supply chain;
- A signed and dated document describing how the claim is not false and misleading.
- A written description of the controls used in each applicable preparation and processing step to support a qualified U.S.-origin claim, including potentially traceability and segregation controls.
The proposal does not specify specific when the above examples would be most appropriate or whether the agency would expect companies to maintain multiple types of documentation, although FSIS indicates it intends to issue guidance if needed.
FSIS has not yet published the proposal in the Federal Register. The agency will accept comments on the proposed rule for 60 days following its publication. Please contact us if you have any questions regarding this proposal.
March 13, 2023, Update: The Proposed Rule has been officially published at 88 Fed. Reg. 15290 (Mar. 13, 2023). Comments are due by May 12, 2023.
Authored by Brian D. Eyink and Connie Potter.
2 USDA has not yet published the proposal in the Federal Register but has made an advance copy available on its website. Advance Copy: Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims, Docket No. FSIS-2022-0015 (May 6, 2023), https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules/voluntary-labeling-fsis-regulated.
6 See, e.g., 7 CFR Part 65. For example, for covered commodity chicken, the statement must declare the country in which the chicken was hatched, raised, and harvested.