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June 7, 2006
FDA has issued the third edition of its guidance entitled "Questions and Answers Regarding Establishment and Maintenance of Records." The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing final rule at 21 CFR Part 1, Subpart J, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation who employ 500 or more full-time equivalent employees (FTEs) had to be in compliance by December 9, 2005, and those who employ 11-499 FTEs have to be in compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have until December 11, 2006 to be in compliance. "Person" includes an individual, partnership, corporation, and association.
The updated Questions and Answers are available online, and provide additional guidance regarding persons covered by the regulation; persons excluded from the regulation, including additional guidance on the farm and restaurant exclusions; and what information is required in the records established and maintained by warehouse distribution facilities. Written or electronic comments on the agency guidance may be submitted at any time. Submit written comments on the guidance to the Division of Documents Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Dockets Open for Comment. Written requests for single copies of the guidance may be made to Gerona Berry, Office of Regulations and Policy (HFS-24), CFSAN, FDA, 5100 Paint Branch Pkwy., College Park, MD 20740. Requests should include the guidance title and one self-addressed adhesive label to assist that office in processing your request. For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 1-888-SAFEFOOD, (Fax) 1-877-366-3322, or by e-mail:
