FDA Issues Interim Rule, Guidance on its Expanded FSMA Access to Food Records

The Food and Drug Administration has issued an interim final rule, effective March 1, 2012, regarding its expanded access to the records of persons that manufacture, process, pack, transport, distribute, receive, hold, or import food, as authorized by the Food Safety Modernization Act (FSMA). Comments on the interim final rule are due by May 23, 2012. The FDA intends to finalize the interim rule one year from the close of the comment period.

Regulations Amended to Reflect FDA’s Expanded Records Access Authority

The interim rule modifies FDA regulations to reflect the FMSA's January 4, 2011 extension of its authority to access records beyond situations where it reasonably believes that an article of food is adulterated and presents a threat of serious health consequences or death, to include situations where: (1) the FDA reasonably believes an article of food to be affected in a similar manner to an adulterated article of food that presents a threat of serious health consequences or death; (2) the FDA believes there is reasonable probability that use of or exposure to an article of food will cause serious health consequences or death; or (3) the FDA reasonably believes that an article of food is affected in a similar manner to an article that will probably cause serious health consequences or death in case of use or exposure.

According to the FDA, decisions regarding whether the FDA “reasonably believes” a food is affected in a similar manner to an article that may cause adverse health consequences or death would be made on a case-by-case basis because such decisions are fact-specific.

FDA Food Industry Guidance Updated to Reflect Changes

In conjunction with its release of the interim final rule, the FDA announced the availability of the fifth edition of its guidance entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food.” The new edition updates the guidance document to reflect the changes made by the interim final rule. According to the FDA, much of the document remains the same as the fourth edition of this guidance, issued in September 2006.

FDA has also announced the availability of a draft guidance for industry entitled “FDA Records Access Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.” The draft guidance is intended for persons who manufacture, process, pack, transport, distribute, receive, hold, or import food, and provides updated information pertaining to the FDA’s authority to access and copy records relating to food, as expanded by FSMA. The FDA is seeking comments on the draft, which is a revision of an FDA guidance document published in November 2005.

21 CFR 1.361 Amended to Implement Change

The interim final rule makes the following changes to 21 CFR 1.361 (deletions struck, additions underlined):

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the actthe Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.

(See ITT’s Online Archives 11010426 for a comprehensive summary of FSMA, including new record keeping requirements.

See ITT’s Online Archives 11030720 for summary of an FDA press release providing background on the FSMA.

See ITT’s Online Archives 12010524 for summary of a January 2012 FDA progress report on FSMA.)

See guidance titled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)” here. See FDA notice announcing the guidance here.

See draft guidance titled “Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act” here. See FDA notice announcing the draft guidance here.

FDA press release on interim rule (dated 02/23/12) available here.