Prior Label Approval System: Expansion of Generic Label Approval rule (2023)

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The Prior Label Approval System: Expansion of Generic Label Approval rule is a significant rule issued by the Food Safety and Inspection Service (FSIS) and the U.S. Department of Agriculture (USDA) effective March 20, 2023, that expanded the circumstances under which the FSIS will approve labels of meat, poultry, and egg products, pursuant to the Federal Meat Inspection Act (FMIA), Poultry Products Inspection, and Egg Products Inspection Act (EPIA).[1]

HIGHLIGHTS
  • Name: Prior Label Approval System: Expansion of Generic Label Approval rule
  • Code of Federal Regulations: 9 CFR 352, 9 CFR 354, 9 CFR 362, 9 CFR 412
  • Agency: Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA)
  • Action: Final rule
  • Type of significant rule: Economically significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    The Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA) require the Secretary of Agriculture to ensure the safety and proper labeling of meat, poultry, and egg products, with approval needed for labels before distribution. The labeling regulations encompass various features, such as accurate product names, ingredient statements, net quantity, inspection legends, handling instructions, nutrition labeling, and country of origin for imports. The USDA's prior approval program involves both sketch approval and generic approval, the latter allowing compliant labels to be used without prior review, and a recent proposed rule aims to expand circumstances for generically approved labels to reduce the regulatory burden on official establishments and enhance focus on other food safety activities.

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:[1]

    “ The Food Safety and Inspection Service (FSIS) is proposing to amend its inspection regulations to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products. FSIS is also proposing to cease evaluating generically approved labels submitted to FSIS for review.[2] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    “ First, FSIS is proposing to extend generic label approval to products only intended for export that deviate from domestic labeling requirements, by removing 9 CFR 412.1(c)(2). FSIS maintains an Export Library that lists requirements for exported products that foreign authorities have officially communicated to FSIS, including labeling requirements. At times, foreign country labeling requirements conflict with domestic requirements. FSIS regulations (9 CFR 317.7 and 381.128) permit export product labels to deviate from FSIS's domestic labeling requirements in order to comply with foreign country requirements or to be marketed more easily in a foreign country. FSIS IPP verify whether product for export meets requirements listed in the Export Library, including labeling, when certifying products for export. Verification of foreign requirements is ultimately determined by each foreign country's competent authority.

    Second, FSIS is proposing to revise the types of 'special statements and claims' requiring label submission by providing for generic approval of three additional types of claims. FSIS has observed through its prior label approval system that errors, omissions, and misrepresentations are rare on these types of labels. The proposed changes are to be made by amending 9 CFR 412.1(e) and 412.2(b).

    The following types of claims would be generically approved:

    a. 'Organic' claims that appear in a product label's ingredients statement, which designate an ingredient as certified 'organic' under AMS's National Organic Program. The ingredients statement on these product labels designates specific ingredients as organic (e.g., organic garlic). FSIS would no longer require the submission and evaluation of supporting documentation to verify that such ingredients are indeed certified as organic by an AMS-recognized third-party certifier. However, FSIS would continue to require that labels certifying a total product as organic to be submitted for FSIS evaluation.

    b. 'Geographic landmarks' displayed on a product label, such as a foreign country's flag, monument, or map. For example, the following claims displayed on a product label would no longer require sketch approval: A polish flag depicted on a Polish sausage product label, or an outline of the State of Nevada depicted on a product label for beef produced in Nevada.

    c. 'Negative' claims made on product labels that identify the absence of certain ingredients or types of ingredients. For example, statements such as 'No MSG Added,' 'Preservative Free,' 'No Milk,' 'No Pork,' or 'Made Without Soy,' on product labels that do not list these ingredients in the ingredients statement would no longer have to be evaluated by FSIS before use. However, FSIS evaluation of labels that bear negative claims relating to the raising of the animal from which the product is derived (e.g., 'no antibiotics administered') or negative claims relating to the use of genetically modified ingredients would continue to be required.

    Third, FSIS is proposing to permit generic approval of the labels of products that receive voluntary FSIS inspection. FSIS provides several types of voluntary inspection services under the authority of the Agricultural Marketing Act (AMA) (7 U.S.C. 1621 et seq.), including inspection for: Rabbits (9 CFR part 354), certain non-amenable species of livestock and poultry animals, such as elk, bison, and migratory water fowl (9 CFR part 352, subpart A, and 9 CFR part 362); and products containing meat or poultry but are not under FSIS jurisdiction, e.g., closed-faced sandwiches (9 CFR 350(c)). At present, labels for some products produced under these voluntary inspection programs are not covered under the Agency's generic approval regulations at 9 CFR 412. FSIS is proposing to permit generic approval for them on the same basis as amenable meat, poultry, and egg products by amending the relevant program regulations where needed to include references to 9 CFR part 412. For clarity, FSIS will also modify 9 CFR 352.1 to update the section heading and remove unnecessary language.

    Finally, FSIS is proposing to cease evaluating generically approved labels submitted voluntarily to LPDS for review. In the 2013 rulemaking that expanded the categories of labels eligible for generic approval, commenters requested to be allowed to continue submitting generic labels for FSIS guidance, evaluation, and approval. FSIS agreed to continue evaluating generic labels that were submitted, giving such labels secondary priority after labels requiring evaluation. Since the 2013 final rule, producers have become more familiar with FSIS's generic labeling requirements, and FSIS has provided additional guidance to assist them in designing compliant labels. Therefore, FSIS's evaluation of otherwise generic labels no longer represents an efficient use of Agency resources.[2]

    		”

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the Prior Label Approval System: Expansion of Generic Label Approval states that OMB deemed this rule economically significant under E.O. 12866:

    “ This final rule has been designated by the Office of Information and Regulatory Affairs a 'significant' regulatory action under section 3(f) of E.O. 12866.[2] ”

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 Federal Register, "Prior Label Approval System: Expansion of Generic Label Approval," September 14, 2020
    2. ↑ 2.0 2.1 2.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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