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USA - Food and Drug Administration, HHS Interim final rule; request for comments on Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements

FDA issued an interim final rule (IFR) and draft guidance for industry amending FDA’s existing regulation on maintaining records about sources and recipients of food (FSMA Section 101). FDA also published an update to its Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4), to ensure the guidance is consistent with the new FSMA requirements. Note: Food includes animal feed.

March 1, 2012

Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements

Food and Drug Administration, HHS.

Interim final rule; request for comments.

SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. 

FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.

DATES: Effective date: This interim final rule is effective March 1, 2012.

Comment date: Interested persons may submit either electronic or written comments on this interim final rule by May 23, 2012.

FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of Compliance (HFS-607), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,  Phone: 240-402-1611      .

Full Federal Register announcement.

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)   

More information on FDA's Food Safety Modernization Act

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