The Food Safety Modernization Act’s provisions on food facility registration are especially significant from FDA’s perspective because they will enable the agency to know much more about the businesses whose products are covered by the landmark law.
On July 14, 2016, the agency issued a final rule on Amendments to Registration of Food Facilities. The amendments aim to improve the registration, which was first required in December 12, 2003 as part of FDA’s implementation of the Bioterrorism Act of 2002. The expanded registration under Section 102 of FSMA builds on the requirement in Section 415 of the Food Drug & Cosmetic Act (FDCA), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA.
Among other changes, the final rule requires an email address for registration. This may seem to be a small change, but a functioning email contact address will greatly enhance FDA’s ability to contact a registered facility or the registered agent. Similarly, the requirement to renew the registration every two years will help ensure that the on-file information remains reasonably up-to-date. In addition, in order to register, facilities will have to assure the agency that FDA will be allowed to inspect the facility.
FDA believes the changes introduced in the new rule will help it to act more quickly in response to food-related emergencies and will help target its inspection resources more efficiently. Effective July 14, 2016, registrations must specify the type of activity conducted at the facility for each food product category. In addition, all registrations must be submitted electronically starting on January 4, 2020.
The final rule includes a provision allowing a registrant to submit a written request for a waiver explaining why it is “not reasonable to submit the registration, registration renewal, update, or cancellation to FDA electronically or to explain why it is not reasonable to provide the email address of the owner, operator, or agent in charge of the facility.”
Definition of retail establishment expanded
Currently, retail food establishments are not required to register as food facilities. The final rule broadens the definition of a retail establishment, so operations in the newly expanded category will not be required to register.
Section 102(c) of FSMA directs FDA to amend the definition of the term “retail food establishment” to include: the sale of food products or food directly to consumers at a roadside stand or farmers’ market where the stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a community supported agriculture program; and the sale and distribution of such food at any other such direct sales platform.
In addition, the agency is requiring additional data elements in food facility registrations, including a unique facility identifier (UFI) and it is planning to verify information submitted in registrations.
At the proposed rule stage, the agency proposed to amend the regulation to shorten the timeframe for submitting updates and cancellations from 60 calendar days to 30 calendar days. However, in response to comments from stakeholders, it has withdrawn that proposal and the final rule requires updates within 60 days of any change.