Small Entity Compliance Guidance for Human and Animal Food facility registrations issued by FDA, May 25, 2018
The U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The SECG explains which types of food facilities are required to register with the FDA, when and how to register. The guide also outlines the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. Note that it is the food facility that must be registered, not related trading companies.
Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.
The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order.
Here, we answer the most frequently asked questions addressed in the SECG:
Who must register under the food facility registration requirements?
If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA, unless you are exempt under 21 CFR 1.226 from the requirement to register. If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce (21 CFR 1.225(b)). If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf (see 21 CFR 1.225(c) and 1.230(a)). A foreign facility’s U.S. agent may, but is not required to, register the facility (21 CFR 1.230).
Who is Exempt from Registration?
- Farms. Note that Farm Mixed-Type Facility as defined by the FDA are required to register.
- Retail Establishments.
- Nonprofit Food Establishments.
- Private residence.
- Facilities that import food into the United States solely for export from a bonded warehouse.
- Facilities that manufacture food contact substances.
However, all facilities that manufacture food additives and color additives for food are required to register. Food additives and color additives for food use are “food” as defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)). Therefore, many food additive and color additive facilities are required to register because these facilities manufacture/process, pack, or hold food for consumption in the United States. However, if a food additive is not intended to have a technical effect in or on the food and meets the definition of a food contact substance in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), it is excluded from the definition of “food” for purposes of food facility registration (see 21 CFR 1.227). (See, for example, Questions C.2.5, C. 2.6, C.2.10, and C.2.12.).
Here, the FDA addresses unique situations when facilities must also register:
In terms of food facility registration, what is the responsibility of a manufacturer of a chemical, substance X, if the manufacturer sells the substance to a customer who uses substance X to produce an indirect food additive?
The term “indirect food additive” is not defined in the FD&C Act or FDA regulations, but is generally used to refer to a food contact substance. For the purposes of food facility registration, the definition of “food” in 21 CFR 1.227 excludes food contact substances, as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), but includes food additives (see 21 U.S.C. 321(f)). Consequently, facilities that manufacture chemicals used in the production of food contact substances are not required to register with FDA. However, if substance X is intended to have a technical effect in or on the food, it is “food” (i.e., a food additive), as defined in 21 CFR 1.227 and section 201(f) of the FD&C Act, and the facility that manufactures substance X must be registered. In addition, if an owner, operator, or agent in charge of a manufacturing facility for substance X reasonably believes that the substance is reasonably expected to be directed to food use, the owner, operator, or agent in charge must register the facility with FDA.
Are facilities that manufacture gum base substances, such as polyvinyl acetate used to produce chewing gum base, required to register?
Yes. Chewing gum is “food” (section 201(f)(2) of the FD&C Act; 21 CFR 1.227). Because polyvinyl acetate chewing gum base is an ingredient (component) of chewing gum, a facility that manufactures/processes, packs, or holds it is required to register, unless the facility is exempt from registration under 21 CFR 1.226.
Does a facility need to register if it manufactures raw materials for dietary supplements?
Yes. Dietary supplements and dietary supplement components are “food” (sections 201(f) and 201(ff) of the FD&C Act and 21 CFR 1.227). Accordingly, a facility that manufactures/processes, packs, or holds a dietary supplement or a component of dietary supplement (i.e., a raw material) is required to register as a food facility.
Are facilities that manufacture/process, pack, or hold food used in research and development or as food samples required to register with FDA?
Yes. Food used in research and development or as product samples is “food” for purposes of the food facility registration requirements of section 415 of the FD&C Act. Accordingly, a facility Contains Nonbinding Recommendations Draft– Not for Implementation 28 that manufactures/processes, packs, or holds food used in research and development or as product samples is required to register with FDA. However, if the food is not for consumption in the United States by humans or animals, the facility is not required to register.
Are the “secondary direct additives” listed in 21 CFR part 173 considered “food contact substances” as defined in section 409(h)(6) of the FD&C Act?
Are facilities that manufacture/process, pack, or hold secondary direct additives required to register? The answer to these questions depends upon the specific use of the secondary direct additive. The regulations in 21 CFR part 173 stipulate the conditions of safe use for certain additives that are added directly to food (such as enzyme preparations) as well as additives that are food contact substances (such as ion exchange resins). A facility that manufactures/processes, packs, or holds a substance approved in 21 CFR part 173 is exempt from registration only if the substance satisfies the definition of “food contact substance” in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)). Otherwise, a facility that manufactures/processes, packs, or holds a substance approved in 21 CFR part 173 is required to register.
In terms of appointing a US Agent, the FDA provides the following guidance:
A U.S. agent may be an individual, partnership, corporation, or association. A U.S. agent must have a place of business or residence in the United States and be physically present in the United States. For example, a foreign facility may use its U.S. importer as its U.S. agent. As established in 21 CFR 1.227, the U.S. agent acts as a communications link between FDA and a foreign facility for both routine and emergency communications. The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact. In functioning as the communications link with FDA, a U.S. agent may choose to initiate communications with FDA, and FDA may likewise choose to initiate communications with the U.S. agent. Further, as stated in the definition for “U.S. agent” in 21 CFR 1.227, FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information or documents to the foreign facility.
Under 21 CFR 1.227, each foreign facility is required to have only one U.S. agent for food facility registration purposes. However, having a single U.S. agent for FDA registration purposes does not preclude a facility from having multiple brokers for other business purposes. A foreign facility is not required to conduct all of its business in the U.S. through the U.S. agent designated for purposes of registration (see 21 CFR 1.227 and Comment 86 in the preamble to the Interim Final Rule; 68 FR 58894 at 58915).
From FDA’s perspective, for registration purposes, listing the name and contact information for the U.S. agent in the registration is sufficient to “authorize” the agent, as long as the U.S. agent has agreed to serve as the U.S. agent for the foreign facility. For its own business reasons, however, a facility may want to formalize its relationship with the agent with some sort of written agreement. Regardless of whether there is a formalized relationship between the facility and its U.S. agent, FDA will verify that the person identified as the U.S. agent for the foreign facility has agreed to serve as the U.S. agent (see 21 CFR 1.231). (See also section II.E.6 of this document for a discussion of the verification procedures for U.S. agents).
When FDA determines a foreign food facility has not registered in accordance with section 415 of the FD&C Act because it does not provide a U.S. agent, FDA may hold shipments offered for import from that facility at the U.S. port of arrival until the facility amends their registration to list a U.S. agent who has affirmatively agreed to serve as such.
2018 is a biennial renewal year for all FDA registered Food Facilities. All facilities must renew their FDA registration with the FDA between October 1 and December 31, 2018.
The FDA addresses the following questions in the guidance document regarding this process:
Does FDA intend to inform food facilities about the registration renewal period?
Yes. Prior to the beginning of the biennial registration renewal (or “registration renewal”) period on October 1, FDA intends to send an email to all registered facilities and U.S. agents for the facilities notifying them of the upcoming registration renewal period. In these emails, we plan to provide general information about the registration renewal process, including the deadline for renewals. Once the renewal period begins, if a facility has not submitted a renewal, we plan to continue to send emails reminding the facility of the upcoming deadline through the end of the registration renewal period on December 31.
Will a food facility be issued a new registration number during the registration renewal process?
No. A food facility will not be issued a new registration number when it renews a current registration.
Am I required to provide my registration number and pin number when I submit my registration renewal?
When you submit a registration renewal via mail or fax, you are asked to provide your facility registration number and pin number (or PIN). For electronic submissions, Account holders in FURLS will not need to provide a registration number or pin because that information is linked to the Account.
Does FDA consider a registration renewal expired if it was properly submitted on or prior to the December 31 deadline but was not timely administered or accepted by FDA on or prior to the December 31 deadline?
In the Registration Final Rule, we added 21 CFR 1.241(b) to specify that FDA will consider a registration for a food facility to be expired if the registration is not renewed, as required by 21 CFR 1.230(b). If a food facility registration or renewal registration is submitted (or postmarked, for paper submissions) on or before the renewal deadline and includes all required information, we will not consider such a registration to be expired. Furthermore, 21 CFR 1.241(c) provides that FDA will cancel a registration if the facility’s registration has expired because the facility has failed to renew its registration in accordance with 21 CFR 1.230(b). For registrations that we do not consider to be expired, we will not cancel the registrations under 21 CFR 1.241(c) (see Comment 26 in the Registration Final Rule; 81 FR 45912 at 45927 to 45928).
Will facilities be required to submit the unique facility identifier (UFI) required in the facility’s registration?
Under 21 CFR 1.232(a)(2), domestic and foreign facilities must submit a unique facility identifier (UFI) recognized as acceptable to FDA in the facility’s registration (see also section F.2 of this document for further discussion of the UFI requirement). Please note, however, that the requirement for providing a UFI in food facility registration submissions will not begin until October 1, 2020.