IC.3.16 Why wait until October 1, 2012 to start the registration renewal process?
The FDA Food Safety Modernization Act (FSMA) mandates that all food facilities that are required to register must renew their registrations every other year during the period beginning on October 1st and ending on December 31st of each even-numbered year. The first registration renewal cycle will occur from October 1 to December 31, 2012.
IC.3.17 What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”? NEW
FDA updated this guidance document (see the new draft verion Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories) to specify additional food categories to be included as mandatory fields in the food facility registration form, as provided by section 102 of the FDA Food Safety Modernization Act (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.”
IC.3.18 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”? NEW
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.