March 2005                        return to newsletter contents page

Corrections Issued on Bioterrorism Act Regulations

Most manufacturers and distributors of pet foods are aware that the Food & Drug Administration (FDA) issued final regulations on December 9, 2004 regarding record keeping requirements under the Bioterrorism Act. The regulations require those who manufacture, process, pack, transport, distribute, receive, hold or import pet food (including treats and chews) to maintain certain records.  The records must identify the immediate previous source of where the food comes from, as well as the immediate subsequent recipient. The records are to be kept for a minimum of one year and must include the contact information of the source and recipient of the food, a description of the food including lot codes or other identifiers, and the quantity of the food and how it is packaged.

Compliance Date

The corrected notice, published in the February 22, 2005 Federal Register, revises the compliance date for small businesses. Businesses classified as small businesses (employing fewer than 500 but more than 10 full-time equivalent employees) must comply by June 9, 2006. Very small businesses (of less than 10 full time employees) have until December 11, 2006 to come into compliance. Large businesses (500 or more employees) must be in compliance by December 9, 2005.

Records Format

The FDA has not established a standard format or form for the required records. They may be kept in any format, electronic or print. They must be retained at the establishment where the activities covered in the records occurred or at a reasonably accessible location. If the FDA has reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals it will request that the records are made available.

For More Information

Click here to access the regulations online.