By Jeffrey H. Brochin, J.D.
Proposed food rule aims to expand the prior approval program for labels used on federally inspected meat, poultry, and egg products that are intended for export, and for certain organic products.
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued a notice of proposed rulemaking that will reduce label approval submissions to the agency by 33.8 percent and reduce label approval costs for industry by $468,864 annually. The proposal is estimated to result in annual savings to the agency of $235,690. The proposed rule will expand the existing "generically approved label program" that permits generic label approval for numerous meat, poultry, and egg products (Notice, 85 FR 56538, September 14, 2020).
Statutory and regulatory background. The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) direct the Secretary of Agriculture to maintain inspection programs designed to ensure that meat, poultry, and egg products are safe, wholesome, not adulterated, and that they are properly marked, labeled, and packaged. The laws prohibit the sale of products under any false or misleading name, marking, or labeling and require the Secretary to approve product marking and labeling. The USDA’s interpretation of those provisions is that they require the Secretary or his or her representative to approve all labels to be used on federally inspected and passed domestic and imported, meat, poultry and egg products, before the products may be distributed in commerce.
Current label requirements. The meat, poultry and egg products labeling regulations require that such products are truthfully labeled, and that the labeling provides the necessary information for consumers to make informed purchasing decisions. There are up to eight features required on the labels, including: (1) the standardized, common or usual, or descriptive name of the product; (2) an ingredients statement containing the common or usual name of each ingredient; (3) the name and place of business of the manufacturer, packer, or distributor; (4) an accurate statement of the net quantity of contents; (5) the inspection legend, including the number of the official establishment; (6) a handling statement if the product is perishable; (7) nutrition labeling; and (8) safe handling instructions if the meat or poultry component of the product is not ready-to-eat. Furthermore, imported products must bear the country of origin under the product name.
Existing generic label approval. Under the existing generic label approval program, FSIS allows certain meat, poultry, and egg product labels that bear all required labeling features and that comply with the agency’s labeling regulations to be generically approved, meaning, that the labels do not need to be submitted to FSIS for sketch approval before they can be used on products in commerce. Generic label approval requires that all mandatory label features are prominent and conform to FSIS regulations. Even though such labels are not submitted to FSIS for approval, they are deemed to be approved and, therefore, may be applied to products in accordance with the agency’s prior label approval system. Generic label approval has been in place in some form since 1983 when FSIS promulgated regulations that granted limited label approval authority to Inspectors-In-Charge (IICs) at official establishments and provided generic approval to limited types of labels.
Proposed expansion rule. FSIS has proposed expanding the categories of meat, poultry, and egg product labels that it will deem generically approved and therefore not be required to be submitted to FSIS. Specifically, under the proposed rule, the following labels would no longer need to be submitted to FSIS for approval: (1) labels on products for export that deviate from FSIS requirements; (2) labels that list ingredients in the ingredients statement as being certified ‘organic’ 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. "No MSG Added," "Preservative Free," "No Milk," etc); and (5) labels of products that receive voluntary FSIS inspection (e.g., exotic species). FSIS is also proposing to cease evaluating labels submitted to FSIS that are eligible for generic approval.
The reforms would result in an estimated 33.8 percent reduction in label submissions (based on fiscal year 2019 data) and reduce agency costs expended to evaluate the labels by $235,690, and, yield a cost savings to industry of $468,864.
Industry stakeholders wishing to comment on the proposed rule may submit comments on or before November 13, 2020.
MainStory: TopStory FDCActNews FoodNews FoodStandardsNews LabelingNews
Interested in submitting an article?
Submit your information to us today!Learn More
Health Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.