FDA Updates FAQ on FSMA Re-Registration and Suspension of Registration
The Food and Drug Administration updated its frequently asked questions on the Food Safety Modernization Act (FSMA) registration requirements, which require facilities that are required to register to re-register every two years, and provide for the suspension of facilities’ registration by the FDA. The re-registrations will begin in October -- December 2012. FDA has been able to suspend registration of facilities since July 3, 2011. New sections of the FAQ include:
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What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Form 3537 is being updated to meet registration renewal needs. The next registration renewal cycle begins Oct. 1, 2012. Facilities may register online via the Internet at www.fda.gov/furls (here), which operates during business hours from 7:00 am to 11:00 p.m. ET.
What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA updated this guidance document (see the new draft version Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories here) to specify additional food categories to be included as mandatory fields in the food facility registration form, as provided by Section 102 of the FSMA). The updated guidance notes that the list of additional food categories includes food categories that are currently included on the food facility registration form as optional fields, including food categories for animal consumption. This guidance also describes certain FSMA amendments to Section 415(a) of the Federal Food, Drug, and Cosmetic Act, which provide that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. This guidance was renamed “Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registration and Updates to Food Categories.”
Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA believes that information about the food categories of foods manufactured, processed, packed or held at food facilities is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. The proposed additional food categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency. See the updated guidance, Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, for more information.
(See ITT's Online Archives 11071915 for summary of other sections of the FDA's FAQ. See also ITT's Online Archives 11080916 for summary of FSMA import safety mandates.)