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FSIS Proposes to Expand Eligibility for Generic Label Approval and to Discontinue FSIS Evaluation of Voluntarily Submitted Labels That are Eligible for Generic Approval

Meat, poultry, and egg products may not be sold, offered for sale, or otherwise distributed in commerce without prior approval of labels by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  Prior approval is granted in one of two ways: (1) “Sketch approval,” which entails Agency review of food labels; and (2) “Generic approval,” which is label approval obtained by virtue of the label being in compliance with applicable regulations.  Generic label approval has been in place in some form since 1983.  In a 2013 rulemaking, FSIS expanded the categories of labels eligible for generic approval and agreed to continue evaluating generic labels that are voluntarily submitted.

In a new Proposed Rule published in the September 14, 2020 Federal Register, FSIS announced plans to cease evaluating labels voluntarily submitted to FSIS that are eligible for generic approval and to expand the types of labels that are eligible for generic approval.  Under this proposal, the following labels would be eligible for generic approval, would no longer be required to be submitted to FSIS for prior approval, and could no longer be voluntarily submitted to FSIS for evaluation:

(1) Labels on products for export that deviate from FSIS requirements;

(2) labels that list ingredients in the ingredients statement as being certified ‘‘organic’’ (e.g., organic garlic) under the Agricultural Marketing Service (AMS) National Organic Program;

(3) labels that display geographic landmarks, such as a foreign country’s flag, monument, or map;

(4) labels that make ‘‘negative’’ claims identifying the absence of certain ingredients or types of ingredients (e.g., statements such as ‘‘No MSG Added,’’ ‘‘Preservative Free,’’ ‘‘No Milk,’’ ‘‘No Pork,’’ or ‘‘Made Without Soy’’); and

(5) labels of all products that receive voluntary FSIS inspection (e.g., rabbits; elk, bison, and migratory water fowl; and closed-faced sandwiches), some of which are not covered under the Agency’s current generic approval regulations.

FSIS has opened a 60-day period (ending November 13, 2020) for submitting comments on the proposed rule.  In addition to fully adopting the proposed rule, FSIS will also consider either taking no action, or adopting the proposed rule in part by continuing to provide industry the option to have FSIS evaluate labels that would otherwise be generically approved.  FSIS will also consider the alternative of having all labels to be generically approved.  No timeline was provided for promulgating a final rule with associated dates for compliance and enforcement actions.

Notably, FSIS states it does not believe this new proposal for expanding eligibility for generic approval and discontinuing evaluation of voluntarily submitted labels that are eligible for generic approval is affected by any of the findings of a June 2020 Audit Report by the Office of Inspector General (OIG) on Controls Over Meat, Poultry, and Egg Product Labels or FSIS’s responses to these findings.  OIG’s June 2020 report includes a finding, disputed by FSIS, of reduced assurance that establishments’ generic labels used in commerce meet requirements because FSIS does not have an adequate process to determine whether establishments’ generic labels meet requirements.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 258

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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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