Q.01

Which meat labels need USDA approval?

Under USDA FSIS rules (9 CFR Part 412), you only have to send three kinds of meat and poultry label to FSIS before use: sketch labels for products made under a religious exemption, labels with "special statements and claims", and requests to use a deficient final label temporarily. All other labels are "generically approved", so you can use them without sending them in, as long as they meet the conditions below.

Approach: I read the current 9 CFR Part 412 (Label Approval) on the official eCFR. The meat inspection regulations aren't in the datasets I can search, and I couldn't check the FSIS directives and guidelines collection this time.

The basic rule: 9 CFR 412.1(a) A final label "may" not be used on any product unless the FSIS Labeling and Program Delivery Staff has approved it, with an application on FSIS Form 7234-1. The only exception is generically approved labels under §412.2. Either way, the establishment "must" keep a copy of every label it uses and show it to USDA on request.

Labels you must submit: §412.1(c)

  1. Sketch labels for products made under a religious exemption. A "sketch" is the concept of a label, such as a printer's proof or a hand-drawn or computer-made mock-up. It must clearly show every labeling feature, its size and its location (§412.1(d)).

  2. Labels with special statements and claims (§412.1(e)(1)), shown on a final label. These are:

    • claims not defined in the federal meat and poultry inspection regulations or the Food Standards and Labeling Policy Book;
    • "Natural" claims, even where the Policy Book defines them;
    • health claims, including heart graphics;
    • ingredient and processing-method claims (e.g. high-pressure processing);
    • structure-function claims;
    • animal-raising claims (e.g. "no antibiotics administered");
    • products labeled organic, unless only individual ingredients are labeled organic;
    • instructions or disclaimers about pathogens (e.g. "for cooking only", "not tested for E. coli O157:H7").

  3. Requests to use a deficient final label temporarily (§412.1(f)). Approval lasts no more than 180 calendar days and needs all four of these:

    • the label would not misrepresent the product;
    • it raises no health, safety or dietary problem;
    • refusing would cause undue economic hardship;
    • approving it would not give an unfair competitive advantage.

    An extension needs new circumstances that meet the same criteria.

Not special claims, so generic approval still applies (§412.1(e)(2))

  • Allergen statements made under the Food Allergen Labeling and Consumer Protection Act (FALCPA), e.g. "contains soy".
  • Negative claims about ingredients that are not in the ingredients list (e.g. "No MSG Added", "Preservative Free", "No Pork").
  • Nutrient content claims that comply with Title 9 of the CFR (e.g. "low fat").
  • Geographic claims (e.g. "German Brand Made in the US"), country-of-origin statements on covered commodities, and images of landmarks, flags or maps.

Generically approved labels: §412.2

  • A label qualifies if it carries every applicable mandatory feature and no special statements or claims. The mandatory features are product name, handling statement, ingredients, name and place of business, net weight, legend, safe handling instructions and nutrition labeling (§412.2(b)).
  • It "must" also show those features prominently under Part 317 (meat) or Part 381 (poultry), and must not be false or misleading (§412.2(a)(1)).
  • FSIS checks samples from establishment records. If it finds a false or misleading label, it will start revocation under §500.8 (§412.2(a)(2)).

U.S.-origin claims: §412.3

  • "Product of USA" and "Made in the USA" "may" be used under generic approval only on these conditions:
    • Single-ingredient products: the animals were born, raised, slaughtered and processed in the US.
    • Multi-ingredient products: inspected ingredients come from such animals, all other ingredients are domestic (spices and flavorings excepted), and preparation and processing happened in the US.
  • Other U.S.-origin claims "may" also be used under generic approval if they describe the steps that took place in the US. The same applies to State, territory or locality claims and to U.S. or State flags.
  • In every case, the establishment "must" keep records that support the claim (§412.3(f)–(g)).

Sources: eCFR 9 CFR Part 412, Label Approval (current)

Q.02