Summary. Meat and poultry establishments are now required to notify their Food Safety and Inspection Service (FSIS) District Office within twenty-four (24) hours of learning or determining that an “adulterated or misbranded” product has entered commerce, according to a final rule passed by the Department of Agriculture (USDA) on May 8, 2012. [See 77 Federal Register No. 89, 26929 – 26937 (Tuesday, May 8, 2012) (the “Final Rule”)]. The Final Rule also requires these establishments to prepare and maintain written procedures for the recall of all meat and poultry products produced and shipped by them and to maintain a record of each reassessment of their Hazard Analysis and Critical Control Point (HACCP) plans. The rule interprets existing provisions of the Food Conservation and Energy Act of 2008 (the Act).1
24 Hour Notice Requirement. Under the Act, an establishment subject to inspection “that believes, or has reason to believe, that an adulterated or misbranded” meat/poultry or meat/poultry food product “received by or originating from the establishment has entered into commerce shall promptly notify the Secretary with regard to the type, amount, origin, and destination” of the meat/poultry or meat/poultry food product. [See 21 U.S.C. §§612; 459(b)]. The Final Rule defines “promptly” to mean within 24 hours of “learning or determining” that such a condition exists.
The preamble to the Final Rule suggests FSIS will strictly interpret this 24 hour period. FSIS rejected comments to the draft rule requesting that holidays, weekends, and microbial test data recovery times be included as factors that would toll the notice period from running. In explaining its rejection of these comments, FSIS noted that in the absence of laboratory results, epidemiological evidence alone may provide “reason to believe” a product is adulterated. FSIS also considered and rejected comments asking that an exception be made to the notice requirement for minor issues that would not pose a safety hazard. This means that any labeling error, however minor, triggers the notice requirement.
Prepare and Maintain Written Recall Procedures. The Act requires establishments to prepare and maintain “current procedures” for the recall of all meat/poultry and meat/poultry food products they produce and ship. The Final Rule interprets the Act to require that establishments put these recall procedures in writing. While establishments must have written recall procedures, at present FSIS does not have legal authority to require a recall. FSIS can detain and seize adulterated or misbranded products in commerce that are not voluntarily recalled.
Variations from Proposed Rule and Compliance Dates. The Final Rule differs from the proposed rule published by FSIS on March 25, 2010, in three significant respects. First, the rule reduced the notice period to 24 hours from the 48 hours initially proposed by FSIS. Second, the rule requires new establishments to prepare their recall procedures contemporaneously with their HACCP plans as a condition of receiving a Federal Grant of Inspection. Finally, for existing establishments, the rule staggers the effective dates for required written recall procedures, based on the size of the producer.
Large producers with 500 or more employees must prepare written recall procedures within six months of May 8, 2012. Smaller establishments with between 10 and 499 employees, and very small establishments with less than 10 employees or less than $2.5 million in annual sales, have one year to prepare their written recall procedures. The notice requirement is effective immediately.
Gray Plant Mooty is a full-service law firm with specialized practices in agribusiness and food safety. Contact Nancy Burke, Susan Gaertner, or Jeff Peterson if you have any questions regarding this alert.
1 These provisions of the Food Conservation and Energy Act of 2008 are codified at 21 U.S.C §§ 612, 613 (meat); §459(poultry).
This article is provided for general informational purposes only and should not be construed as legal advice or legal opinion on any specific facts or circumstances. You are urged to consult a lawyer concerning any specific legal questions you may have.
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