On July 14, FDA issued a final rule amending the requirements for the registration of food facilities (Final Rule).1 The Final Rule was issued as part of the implementation of the Food Safety Modernization Act (FSMA) to help improve the accuracy of the food facility registration database.
Background of FSMA
FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.
New Provisions for Registration of Food Facilities
The Final Rule adds new provisions to the current registration regulations to codify provisions of FSMA that were self-implementing and effective upon enactment of FSMA. FDA states that the new requirements improve the utility of the food facility registration database to further enhance FDA’s capabilities with respect to responding to food-related emergencies, and in addition, provide FDA with information to focus and better utilize FDA’s limited inspection resources.
The Final Rule provides for the following:
- Registrations for domestic food facilities are required to provide the email address for the contact person of the facility, and registrations for foreign food facilities are required to provide the email address of the US agent for the facility.2
- All food facility registrations are required to be submitted to FDA electronically (although this requirement does not take effect until January 4, 2020).3 Renewals must be submitted every two years between October 1 and December 31 of each even-numbered year.4
- Registrations are now required to indicate the type of activity conducted at the facility for each food product category.5 Importantly, this became a requirement when the Final Rule became effective on July 14, 2016, which is prior to the October–December 2016 registration renewal period.
- Beginning October 1, 2020, food facilities will need to provide a unique facility identifier (UFI) as part of the registration process.6
Definition of “Retail Food Establishment”
The Final Rule also amends the definition of a “retail food establishment” in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with FDA as food facilities.7 In determining the primary function of an establishment (which is required to register) or a retail food establishment (which is exempt), the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include
- the sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such 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 as determined by the Secretary [of Health and Human Services].8
These new requirements bring the food registration requirements and database more closely aligned with FDA’s requirements for other registration and listing databases (e.g., drug registration and listing, and device registration and listing).
We will continue to monitor FDA administrative requirements as FDA continues to expand and implement FSMA requirements.
1Amendments to Registration of Food Facilities; Final Rule, 81 Fed, Reg, 45912 (July 14, 2016) https://www.gpo.gov/fdsys/pkg/FR-2016-07-14/pdf/2016-16531.pdf.
2FSMA § 102(a)(1)(A).
3FSMA § 102(b).
4FSMA § 102(a)(3).
5FSMA § 102(c).
681 Fed. Reg. 45950.
781 Fed. Reg. 45913.
8FSMA § 102(c) (to be codified at 21 C.F.R. § 1.227).