FSIS Proposes to Further Expand the Types of Labels that Do Not Require Pre-Market Approval

December 8, 2011

By Riëtte van Laack

On December 5, 2011, the Food Safety Inspection Service (“FSIS”) of the USDA proposed to amend its regulations concerning label approval of meat and poultry products.  The proposed rule would further expand the types of labels that do not require pre-market approval, and would streamline the labeling regulations by placing all the label approval regulations for meat and poultry products in one Part of the CFR.

Traditionally, the FSIS has interpreted the Federal Meat Inspection Act (“FMIA”) and Poultry Products Inspection Act (“PPIA”) to require that labels for federally inspected meat and poultry products be approved before the meat and poultry products are marketed.  Generally, except when the label is generically approved, establishments must submit for approval sketches of their labels showing all required label features and any special claims that the establishments intend to make, e.g., quality claims, natural claims, and nutrient content claims.  Generic label approval refers to the prior approval of labels or modification to labels by FSIS without sketches being submitted for approval by FSIS.  Generic label approval requires that all the mandatory label features conform to the applicable FSIS regulations.  Although such labels are not submitted to FSIS for approval, they are deemed to be approved and therefore may be used. 

In 1983, FSIS issued its first regulations providing for generic label approval for some types of labels.  In 1995, FSIS significantly expanded the types of labels eligible for generic label approval to include labels for products with a standard of identity, single ingredient products that do not bear a voluntary statement, labels for meat and poultry products not intended for human food, etc.  Although this expansion resulted in a significant reduction of the number of labels subject to prior approval, the regulations remained restrictive regarding the types of labels subject to generic approval.  For example, a change in the order of predominance of ingredients of a non-standardized product such as meat pizza still required sketch approval by FSIS.  Consequently, a large number of sketches continued to be submitted, burdening the industry and FSIS.  Therefore, 16 years after the first expansion of generic label approval, the Agency proposes to further expand the types of labels that can be generically approved.  The Agency estimates that the proposed amendments will reduce the number of labels requiring approval in the first year by approximately 70%.  The reduced burden on FSIS will allow the Agency to better focus on, and direct its resources to, other consumer protection and food safety activities.

Under the proposed rule, establishments will have the responsibility to ensure that all the basic requirements (i.e., product name, safe handling statement, ingredient listing, address line, net weight, legend, safe handling instructions, nutrition labeling for multi-ingredient products, and the country of origin and mark of inspection of the foreign system for imported meat and poultry products) are met.  Only certain types of labels bearing statements and claims that are likely to present policy issues and have health or economic significance will remain subject to premarket approval (e.g., labels for temporary approval, labels for products produced under religious exemption, labels for export with labeling deviations, and label claims and special statements, including “natural” and “organic” statements).  However, when a product label contains a special statement or claim, FSIS will only evaluate that special statement or claim, not the mandatory statements.  Special statements will not include allergen statements, sell by dates (and other calendar date statements), “fresh” statements on poultry, statements concerning the USDA approved quality control system logo, and statements required on irradiated products; FSIS believes industry has sufficient experience with these special statements, and that the regulations (and guidances) for these special statements clearly prescribe the applicable requirements, such that no review by FSIS is required.  

Comments may be submitted through February 3, 2012.