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Draft FDA Compliance Policy Guide on Food Facility Registration Open for Comment

Thursday, April 04, 2013
By Shawn McCausland
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has made available for public comment a draft compliance policy guide on food facility registration. This draft is intended to provide guidance for FDA staff on enforcement of the food facility registration requirements of section 415 of the Federal Food, Drug and Cosmetic Act and also contains information that may be useful to the regulated industry and the public. Comments should be submitted no later than May 6 to be considered as the FDA begins work on the final version of the guide.

Section 415 of the FD&C Act requires owners, operators or agents in charge of domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register their facilities with the FDA. The Food Safety Modernization Act amended section 415 to require registrants for food facilities to submit additional registration information and renew such registrations biennially. FSMA also amended section 415 to provide that if the FDA determines that food manufactured, processed, packed, received or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals it FDA may suspend the registration of a facility that (1) created, caused or was otherwise responsible for such reasonable probability or (2) knew of, or had reason to know of, such reasonable probability and packed, received or held such food.

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