FDA has finalized an earlier released draft guidance providing additional information regarding food facility registrations required by section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA). The guidance establishes new categories for food facilities as mandatory fields in the food facility registration form. At the same time, FDA announced that its biennial registration renewal program for food facilities will begin on October 22, 2012. Both the guidance and biennial registration renewal program implement provisions of the Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011 and expanded FDA authority over the global food supply chain to minimize the risks of unsafe food.
Section 415 of the FDCA, as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, requires that “any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States” must register with FDA by providing contact information along with “the general food category” of food manufactured, processed, packed, or held at the facility. Section 102 of FSMA provided FDA with new authority by expanding required information for food facility registration to include submission of “any other food categories as determined appropriate by the Secretary, including by guidance.” Section 102 of FSMA also requires that “[t]he registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.”
FDA explained in the new food facility registration guidance that “[b]ecause of Congress’s explicit statutory authorization [in section 102 of FSMA] to effectuate a binding requirement based on findings in guidance,” the guidance is not subject to ordinary restrictions and establishes binding requirements that food facilities must comply with when registering with FDA. In support of the need for new categories, FDA explained that food category registration “helps FDA conduct investigations and surveillance operations in response to food-related emergencies” and “enable[s] FDA to quickly alert facilities potentially affected by such an incident if FDA received information indicating the type of food affected.” FDA also plans to use information submitted regarding new food categories to assess whether a facility is high-risk for inspection purposes and has explained in the FSMA Domestic Facility Risk Categorization (FY 2012) that “[i]f a facility manufactures food commodity categories associated with foodborne outbreaks AND class I recalls, then they are placed in the [high-risk] facility category.” Section 201 of FSMA requires the frequency of inspections for domestic food facilities to be based on risk.
The additional food categories that will be included in food facility registrations going forward are the same as those initially proposed in the August 2012 draft guidance. Those categories both break down existing food categories into more detailed subcategories and establish entirely new product categories. The guidance expands on the draft guidance by providing a catch-all so that “[i]f none of the human food categories listed in the registration form apply, [the food facility should] print the applicable food category or categories.”
FDA simultaneously announced that updated biennial registration renewal system for food facilities became available at 12:01 a.m. October 22, 2012. Section 102 of FSMA requires food facilities to submit a registration renewal “[d]uring the period beginning on October 1 and ending on December 31 of each even-numbered year.” Instructions for biennial registration renewal are available here. FSMA instructs that the registration period is to end on December 31, however, the FDA has indicated it may extend this deadline for this period due to delays in implementing the system.
If a facility fails to renew its registration or the FDA suspends a facility’s registration, that facility is prohibited from importing or exporting food in the U.S., or otherwise introducing food into interstate or intrastate commerce. Under FSMA, the FDA can suspend facility registration if the FDA determines “that food manufactured, processed, packed, received, or held by a facility registered under [section 102] has a reasonable probability of causing serious adverse health consequences or death to humans or animals.”