Correction - FDA Final Rule on Recordkeeping Under the Bioterrorism Act Takes Effect February 7, 2005
The Food and Drug Administration (FDA) has issued a final rule that will require the establishment and maintenance of records by persons (except farms, restaurants, and certain others) who manufacture, import, process, pack, transport, distribute, receive, or hold food in the U.S. This final rule takes effect February 7, 2005.
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According to the FDA, such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food.
The final rule will be published in the December 9, 2004 Federal Register, and will implement section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
According to the FDA, under the final rule, 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.
The FDA also states that records must be retained at the establishment where the activities covered in the records occurred, or at a reasonably accessible location.
To minimize the burden on food companies affected by the final rule, the FDA states that companies may keep the required information in any format, paper or electronic.
In addition, the FDA states that when it has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse 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, not to exceed 24 hours from the time of receipt of the official request.
FDA states that once it makes the necessary determination, an investigator or other FDA personnel will submit a written notice, FDA-482- Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and the FDA's legal authority to obtain these records. FDA may request additional records related to the implicated food article at a later time under the same authority.
Final Rule is Effective February 7, 2005, But Compliance Date Depends on Size of Business
The FDA's final rule is effective 60 days after December 9, 2004 (i.e., February 7, 2005), and has several different compliance dates, depending on the size of the business.
According to the FDA, all businesses covered by this rule must comply within 12 months from the date the rule is published in the Federal Register, except 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) have to comply within 24 months from this date.
FDA states that it will be holding seven public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and answer questions.
FDA contact - Nega Beru (301) 436-1400
FDA draft of final rule available at http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0277-nfr0001.pdf.
FDA press release announcing final rule (No. P04-109, dated 12/06/04) available at http://www.fda.gov/bbs/topics/news/2004/NEW01143.html.
FDA fact sheet on final rule (dated December 2004) available at http://www.cfsan.fda.gov/dms/fsbtac23.html.
FDA announcement of public meeting, proposed schedule, and registration instructions (dated December 2004) available at http://www.cfsan.fda.gov/dms/fsbtac24.html.
FDA Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (dated December 2004) available at http://www.cfsan.fda.gov/dms/secgui12.html,
(See ITT's Online Archives or 05/13/03 news, 03051305, for BP summary of FDA's Bioterrorism proposed rule on recordkeeping.)
BP Note
The December 8, 2004 ITT summary in the Online Archives and Current News, 04120810, has also been corrected to reflect a February 7, 2005 (not February 7, 2004) effective date.