- FDA intends to exercise FSMA enforcement discretion with respect to registration renewals submitted to FDA after Dec. 31, 2012 for a period of 31 days -- until Jan. 31, 2013.
As a part of the Food Safety Modernization Act (FSMA), all facilities (including cotton gins and cottonseed storage) that manufacture, process, pack or hold food for human or animal consumption within the United States or foreign facilities that export to the United States must re-register in even numbered years beginning with 2012.
However, the Food & Drug Administration (FDA) issued a guidance document stating that because there was a delay in FDA’s implementation of biennial registration renewal for the ’12 cycle, and registration renewal did not become available until Oct. 22, ’12, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after Dec. 31, ’12 for a period of 31 days -- until Jan. 31, ’13. The guidance document can be found by going to www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htmand finding the recently-added link: Questions and Answers Regarding Food Facility Registration (Fifth Edition).
National Cotton Ginners Assoc. Executive Vice President Harrison Ashley reiterated that there is no cost for gins or cottonseed storage facilities, which this year and biennially thereafter must re-register (or register this year if not previously registered).
Gins and cottonseed storage facilities were required to register in '03 under the FDA Food/Feed Bioterrorism Rule. The FSMA will incorporate the existing FDA Food/Feed Bioterrorism Rule. Details are at www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm. Registration instructions and forms are at: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/ucm073728.htm.