FDA issues recordkeeping rule.

AuthorSwartz, Nikki
PositionUP FRONT: News, Trends & Analysis

The U.S. Food and Drug Administration (FDA) has issued final regulations on the establishment and maintenance of records to protect the security of the U.S. human and animal food supply in the event of bioterrorism and other threats.

The final rule implements section 306 of the Bioterrorism Act, which directs the Health and Human Services secretary to issue regulations requiring people who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records will identify the immediate, previous source of all food received as well as the immediate, subsequent recipient of all food released.

"These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Lester M. Crawford, acting FDA commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable the FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply.

The retention periods for human food records range from six months to two years depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum record retention requirement for transporters of...

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