FDA Releases Final Food Bio-Terrorism Rule

December 10, 2004

December 10, 2004 -- The U.S. Food and Drug Administration (FDA) has issued final regulations on the establishment and maintenance of records meant to protect the U.S. food supply in the event of credible threats to the health of humans and animals.

The regulations require people who manufacture, process, pack, transport, distribute, receive, hold or import food to establish and maintain records. The records identify the immediate source of all food received, as well as the immediate recipient of all goods released.

Businesses with 500 full-time employees or more that are covered by this rule must comply within 12 months from the date the rule is published in the Federal Register. Smaller businesses will have more time to comply.

The record retention period for human food ranges from six months to two years depending on the shelf life of the food. Records for animal food must be retained for one year, which is the same retention requirement for transporters of all food types.

FDA will conduct seven public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and to answer questions. Additional information regarding the meetings and information about the rules designed to protect the U.S. food supply are available at: Meeting Information on the World Wide Web.



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