Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

February 2012

Contains Nonbinding Recommendations

Available in PDF (304KB) only.

Docket Folder FDA-2011-D-0598 for commenting

FDA is announcing the availability of a guidance entitled “Questions and Answers Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5),” which replaces the fourth edition of a guidance of the same title issued in September 2006. The guidance is intended for persons who manufacture, process, pack, hold, or import human or animal foods intended for distribution to consumers, institutions, or food processors.

In the Federal Register of December 9, 2004 (69 FR 71562), FDA published a final rule implementing sections 414 and 704 of FD&C Act (21 U.S.C. 350c and 374) as amended by section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The final rule 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. FSMA, signed into law on January 4, 2011 (Pub. L. 111-353), amended sections 414 and 704 of the FD&C Act by expanding FDA's access to records relating to foods that may cause serious adverse health consequences or death to humans or animals. In February 2012, FDA issued an interim final rule that revises § 1.361 (21 CFR 1.361) to reflect the FSMA amendments to the FD&C Act. This guidance document has been updated to reflect these changes.

On September 12, 2005, FDA issued the first edition of a guidance entitled “Questions and Answers Regarding the Establishment and Maintenance of Records.” This document is the fifth edition of that guidance and is updated to reflect changes to the FD&C Act made by FSMA. This guidance is intended to provide individuals in the human and animal food industries with an updated overview of FDA's access to records. It provides practical information by answering common questions that cover a range of topics, including who is subject to records requirements, the scope of records retention and availability requirements, and the consequences of failing to establish and maintain required records or failing to make required records available to FDA. This guidance is being issued consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115) as a level 1 guidance. The Agency will accept comments, but it is implementing this document immediately, in accordance with § 10.115(g)(2) because the Agency has determined that prior public participation is not feasible or appropriate. The Agency made this determination because this guidance simply reflects the statutory changes made by section 101 of FSMA to sections 414 and 704 of the FD&C Act and seeks to remove any confusion that might arise due to the existence of a guidance document that is inconsistent with the FD&C Act and its implementing regulations. In addition, much of this guidance remains the same as the guidance issued in September 2006.

This guidance represents the Agency's current thinking on its authority to access and copy records. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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