On May 8, 2012, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published a final rule regarding adulterated or misbranded meat and poultry products. FSIS’s new rule implements provisions of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill), which amended the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).

Specifically, the new rule imposes the following requirements on official establishments:

  • Within 24 hours, an official establishment must notify the appropriate USDA District Office if it believes or has reason to believe that an adulterated or misbranded product received by or originating from that entity’s establishment has entered into commerce;
  • Prepare and maintain written procedures for the recall of all products produced and shipped by the establishment;
  • Document each reassessment of its Hazard Analysis and Critical Control Point (HACCP) plans, including documentation regarding the reason for changing or not changing the HACCP plan based on the reassessment; and
  • Upon request, make the HACCP plan available to FSIS inspectors to review and copy.

In promulgating the new rule, FSIS rejected a suggestion to model notification requirements on the Food and Drug Administration notification standard, which only requires notification when there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death. Under FSIS’s rules, all covered entities will have to notify the appropriate USDA District Office anytime it believes or has reason to believe a product is adulterated or misbranded under FMIA or PPIA and has entered into commerce. Based on this standard minor labeling errors could trigger notification. The new rule became effective on May 8, 2012, but entities will not have to comply with certain provisions, such as written recall procedure requirements, for six months to a year from the effective date depending on the size of the entity.