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FDA issues final BT Act ruling

January 8, 2005
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The Food and Drug Administration (FDA) issued final regulations on the establishment and maintenance of records last month to protect the US food and animal feed supply. The agency also issued a draft guidance which details the internal procedures the agency will follow before requesting access to records.



This final regulation implements section 306 of the Bioterrorism Act and covers records that 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 Dr. Lester M. Crawford, acting FDA commissioner. The records enable FDA to trace forward to remove adulterated foods that pose a significant health threat in the food supply, Crawford stated.

The record retention period for human foods ranges 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 all types of food is one year.

Records must be retained at the establishment where the activities occurred or at a reasonable, accessible location. Food companies may keep the required information in paper or electronic format. All businesses covered by this rule must comply within 12 months from the date the rule is published in the Federal Register, except for small and very small businesses. Small businesses (11-499 full-time equivalent employees (FTEs)) must comply within 18 months from this date, and very small businesses (10 or fewer FTEs) within 24 months from this date.



When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious health consequences or death to humans or animals, any records or other information to which FDA has access must be available for inspection and copying as soon as possible, or within 24 hours from time of receipt of the request.

"Many companies expressed serious concerns about their ability to deliver so much detailed information in a short time when an investigation takes place," said Jim Brown, sales manager for Wonderware eCompliance Solutions. According to Brown, Wonderware provides a solution that is affordable, secure, paperless, easy-to-use and quick to deploy, regardless of a processor's existing business or operations systems.

FDA will hold seven public meetings in January and February to explain the requirements of the final rule. More information is available at www.fda.gov/oc/bioterrorism/bioact.html.

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