The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend and improve its regulations on food facility registration. Facilities that manufacture, process, pack, or hold food for consumption in the U.S. must register with FDA, but “retail food establishments,” farms, restaurants and certain other entities are exempt from the requirement. The proposed rule would amend the definition of a retail food establishment to expand the number of facilities that wouldn’t have to register. FDA estimates that there are about 71,000 farms that only sell food directly to consumers through roadside stands, farmers markets, and Community Supported Agriculture (CSA) programs, and these would fall under the expanded exemption. The additional establishments would then also not be subject to the requirements of the Food Safety Modernization Act (FSMA) preventive controls rule, which applies to facilities that are required to register. “One of the most concerning aspects of the FSMA rules for farmers has been the confusion surrounding when FDA will consider a farm to also be a food facility,” said Sophia Kruszewski, policy specialist with the National Sustainable Agriculture Coalition. “This clarification is critical to understanding and avoiding FSMA’s adverse impacts on the growing local and regional food sector.” For facilities that are not exempt from registration, FDA’s new rule would codify certain provisions of FSMA:
- Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
- Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
- All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.
FDA is accepting public comments on the proposed rule beginning April 9.