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September 21, 2006
The Food and Drug Administration (FDA) has issued the fourth 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 had 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 and persons excluded from the regulation, including additional guidance on the farm exclusion. In addition, we are amending the response to question 4.2 to clarify that while post-harvesting activities related to hay are subject to the rule, certain activities that are part of harvesting remain within the farm exemption. This guidance is intended to help the industry better understand and comply with the regulation in 21 CFR Part 1, Subpart J. The FDA is issuing this guidance as a Level 1 guidance. The guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public.
Written or electronic comments on this 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), Center for Food Safety and Applied Nutrition (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 CFSAN at 1-888-SAFEFOOD, (Fax) 1-877-366-3322, or by e-mail: .
