FDA Finalizes Bioterrorism Rules

Federal rules finalized in December require people who manufacture, process, pack, transport, distribute, receive, hold or import pet food, treats and chews to establish and maintain records on the products, according to the American Pet Products Manufacturers Association (Greenwich, Conn.).

In accordance with the Bioterrorism Act, the Food and Drug Administration will require parties to keep records for a minimum of one year for animal feed, including pet food. The records must be retained at the establishment where the activities covered in the records occurred, or at a reasonable accessible location. The records must include:

  • Identification of the immediate previous source of the food as well as the immediate subsequent recipient.
  • Contact information for the source and recipient of the food.
  • A description of the food, including lot codes or other identifiers.
  • The quantity of the food and how it is packaged.

The FDA may demand to see the records if it has reason to believe that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

The FDA also issued draft guidelines detailing internal procedures the agency will follow before requesting access to records.

Persons who fail to comply with the regulations can face civil and criminal action in federal court.

Most businesses must comply with the regulations within 12 months of their Dec. 9, 2004, publication date. Businesses with 11 to 499 full-time employees have 18 months to comply; businesses with fewer than 11 full-time employees have 24 months.
For more information, visit www.cfsan.fda.gov/~dms/secgui12.html. [February 2005 PET AGE]


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