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FSIS Rule Expanding Generic Label Approval Should Benefit Industry, but at What Cost?

Last week, the Food Safety and Inspection Service (FSIS) published a final rule to significantly expand the categories of meat and poultry labels that may be generically approved without formally submitting them to FSIS for approval, as well as a Labeling Compliance Guidance regarding the final rule.  Currently, labels that are applied to meat and poultry products must be submitted to FSIS for label approval unless the type of label, or a type of modification to a previously approved label, is specifically listed as “generically approved” in FSIS regulations.  Beginning on January 6, 2014, all meat and poultry labels and any modifications to such labels will be considered generically approved, unless they fall into one of the following four categories:

  • Labels for temporary label approval;
  • Labels for products produced under a religious exemption;
  • Labels for products for export with labeling deviations (other than printing in foreign language and quantity of contents statements); and
  • Labels with “special statements and claims”, defined as:
    • Natural claims;
    • Negative claims;
    • Additional claims, logos, trademarks, and other symbols that are not defined in the FSIS meat and poultry regulations or the FSIS Food Standards and Labeling Policy Book (except for Child Nutrition (CN) boxes).

FSIS predicts in the final rule that it will experience a 69 percent reduction in the volume of labels submitted for review and approval due to the final rule.  This estimate may be artificially high because the final rule still allows firms to voluntarily submit to FSIS labels that qualify for generic approval (these labels will receive less priority for label review).  Notwithstanding, the final rule is expected to significantly reduce the amount of labels that FSIS will have to review, thereby reducing the turnaround time for reviewing and approving labels that are required to be submitted (currently at 7 weeks).  It should also allow many establishments to get their products to the market in a more timely fashion.

This is not to say there will be no costs associated with the final rule.  Establishments that previously submitted labels to FSIS for approval, but now take advantage of the new generic approval regulations, will no longer have a formal approval from the FSIS’ Labeling and Program Delivery Staff (LPDS) in case there is a labeling dispute with in-plant inspection personnel.  Without such approval, inspection program personnel may be more inclined to retain product when they believe that a label does not meet FSIS labeling requirements or is otherwise false or misleading (at least until the establishment can appeal the decision, convince the LPDS to intervene or obtain a temporary label approval).  Based on our discussions with FSIS officials, it is our understanding that FSIS will conduct training and issue guidance to inspection personnel instructing them to focus on labeling issues of public health significance and to check with the LPDS in situations were there is a valid dispute on label compliance.  However, FSIS will not deter inspection personnel from retaining product when they believe labels do not meet FSIS requirements.   This could result in unnecessary costs to the industry.

For the above reasons, establishments that choose to generically approve their labels should be extra diligent in reviewing their labels for compliance with FSIS requirements.  Special attention should be paid to ensuring that:

  • The product meets any applicable standard of identity;
  • The label bears all required features;
  • All ingredients listed on raw materials and used in the product formulation (especially ingredients of public health significance) are identified on the label unless FSIS has expressly determined the substance qualifies as an incidental additive; and
  • Claims comply with requirements set forth in the FSIS regulations or the Policy Book.

Should inspection personnel still retain product in error, establishments should immediately contact the LPDS staff for assistance, or if not available, appeal the regulatory control action to their Front Line Supervisor and/or District Office.

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