FDA issues final rule on records access rule

04/03/2014 01:39:00 PM
Tom Karst

The Food and Drug Administration is expanding authority to demand access to company records relating to contaminated food that could be a threat to human health.

A final rule issued April 3 adopts, without change, an interim rule issued in February 2012, according to a news release from the FDA.

The regulation, prompted by Congressional authority given in the 2011 Food Safety Modernization Act, allows the FDA to demand access to records beyond those relating to specific suspect food articles if the agency reasonably believes that other food articles are likely to be affected in a similar manner, according to the release. The rule also permits FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals, according to the release.

The agency also said it was issuing a guidance document called “What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide” and another guidance document  that describes FDA’s new authority to access company records.



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