The Food and Drug Administration recently issued a final rule amending its regulations for food facility registration to codify certain provisions mandated by the Food Safety Modernization Act. The rule also allows FDA to collect additional information about food facilities to improve the agency’s use of the registration database, enhance response to food-related emergencies and provide specific focus for FDA’s inspection resources.
The rule will take effect 60 days from tomorrow, July 14, when it will be published in the Federal Register.
Currently, food facilities that manufacture, process, pack or hold food for consumption in the United States must register with FDA. The final rule adds the following provisions:
- Food facility registrations must include an email address for the contact person of a domestic facility or U.S. agent for foreign facility registrations;
- All facilities must renew their registration every two years, between October 1 and December 31 in even-numbered years;
- Food facilities must submit registrations electronically starting in 2020;
- FDA will establish an abbreviated registration renewal process for registrants that have not had any changes to information since the preceding registration;
- Facility registrations must contain an assurance that FDA can inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.
Other important provisions of the rule and changes from the proposal include:
- Facilities are not required to obtain a D-U-N-S number (a unique nine-digit identifier provided by Dun & Bradstreet that is specific for each site), but they must include a unique facility identifier that FDA must verify prior to issuing a registration number;
- Registrations submitted by individuals other than the owner, operator or agent in charge (third-party registrations) must be verified by FDA prior to issuing a registration number. FDA plans to issues guidance on how it will conduct this verification step;
- FDA can cancel a registration if it verifies a facility is no longer in business, has changed owners, fails to cancel its registration, or has not updated its address in a timely fashion;
- FDA can independently cancel a registration if a facility fails to renew the registration, but will provide notice prior to canceling;
- As of July 14, 2016, facilities will be required to identify the type of activity conducted at the facility for each food product category; and
- FDA will establish a U.S. Agent Voluntary Identification System similar to what was included in the proposed rule.
Retail food establishments, farms, restaurants and certain other entities currently are exempt from the registration requirement. As mandated by FSMA, the final rule clarifies the exemptions by redefining “retail food establishments” to include sales by farm operations that occur at direct-to-consumer sales platforms such as roadside stands, farmers markets or through Community Supported Agriculture programs.
FDA will host a webinar on August 3 at 11 a.m. Eastern time to discuss the final rule in more detail. More information about the rule and webinar can be found on the FDA website.
Members with questions may contact Emily Lyons, IDFA director of regulatory affairs and counsel, at email@example.com.