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Today, the U.S. Food and Drug Administration released is the seventh edition of a guidance which answers several questions around the following topics:

1. Who Must Register
2. Who is Exempt
3. Definitions of Food
4. Holding Facilities
5. Trade Names
6. US Agent for FDA Registrations of foreign food facilities
7. When to register and renew your FDA registration
8. Unique Facility Identifier Number (October 2020)
9. Updates and Changes to FDA Registration
10. Is Food Registration information publicly available?

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?

1. Farms – See the guidance for specific definitions of farms that are exempt from registration. However, if your farm is a “farm mixed-type facility,” you must register. The term “mixed-type facility” means an establishment that engages in both activities that are exempt from registration and activities that require the establishment to be registered.

Below are several examples to help farms determine if they are required to register.

If a farm located in a foreign country ships food directly to the United States, is it required to register?
No. A farm located in a foreign country that ships food directly to the United States is exempt from the registration requirements of section 415 of the FD&C Act (21 U.S.C. 350d; 21 CFR 1.227). However, if prior to shipping to the United States, the farm ships the food to a foreign facility that manufactures/processes, packs, or holds the food, the second facility must register unless the food subsequently undergoes further manufacturing/processing of more than a de minimis nature at another foreign facility (21 CFR 1.226(a)). The de minimis provision (21 CFR 1.226) is discussed further in Question C.3.5 in this document.

Is a mixed-type facility, such as a farm that grows oranges and processes them into orange juice for sale to a distributor, required to register?
Yes. The term “mixed-type facility” means an establishment that engages in both activities that are exempt from registration and activities that require the establishment to be registered. An Contains Nonbinding Recommendations 7 example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but also conducts activities outside the “farm” definition that require the establishment to be registered (21 CFR 1.227). In this example, the farm mixed-type facility is required to register.

Does a farm need to register if it grows its own produce, harvests it, wraps it, and places it into cartons for the sole purpose of transporting the food off the farm?
No. The “farm” definition provides for farms to pack food (21 CFR 1.227 at (1)(i)). Wrapping produce and placing it into cartons for transporting the food off the farm is packing and is within the “farm” definition.

Is a truck-mounted operation required to register if it travels from one vineyard to another and bottles wine made from grapes grown and processed into wine at the vineyard?
Yes. A truck-mounted operation that travels from one vineyard to another and bottles wine is a mobile facility that must be registered. Bottling wine is “packaging,” which is an activity included in the definition of “manufacturing/processing” (21 CFR 1.227).
Manufacturing/processing” is defined as “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.” Bottling wine involves manipulation of the wine because it is preserving the manufactured condition of the wine by vacuum-sealing it and corking it. Thus, the truck-mounted operation that bottles wine is a facility that is required to register. Furthermore, the exception in 21 CFR 1.227 for farms (both primary production farms and secondary activity farms) that perform packaging and labeling without additional manufacturing/processing only applies to packaging and labeling of RACs, and wine is a processed food.

Does a farm need to register if it grows a crop, harvests it, and holds it for a period of time before shipping it to a distributor (e.g., grain elevator) or manufacturer/processor?
No. Holding a harvested crop for a period of time before providing it to a distributor or manufacturer/processor does not result in the farm being required to register.

2. Retail Establishments. A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sale of all food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. See the FDA definition of a retail food establishment, to determine if it is exempt from registration ( 21 CFR 1.227).

Below are two examples to help retail establishments determine if they are required to register.

Does a warehouse club that sells to both consumers and businesses need to register?
A warehouse club is exempt from registration as a retail food establishment if it sells food products directly to consumers as its primary function. A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food Contains Nonbinding Recommendations 13 products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. Businesses are not considered consumers. Thus, if the annual monetary value of sales of food products directly to businesses exceeds the annual monetary value of sales of food products to consumers, the warehouse club must register (21 CFR 1.227).

If a bakery primarily sells its food directly to consumers, but 40% of its annual sales are to wholesale facilities, does the bakery have to register?
No. The bakery is a “retail food establishment” and does not need to register. A retail food establishment is exempt from registration if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers (21 CFR 1.226(c) and 1.227).

If I supply food directly to consumers via the Internet or mail-order, am I a retail food establishment?
Maybe. Facilities that sell food directly to consumers via the Internet or mail-order may be retail food establishments, provided they meet the other criteria of the “retail food establishment” definition in 21 CFR 1.227 (see Comment 82 in the Interim Final Rule; 68 FR 58894 at 58914 to 58915).

3. Restaurants
4. Non-profit food establishments
5. Fishing vessels
6. Facilities Regulated Exclusively by the United States Department of Agriculture (USDA)
7. Human and Animal Food brokers

How does the FDA define food?

The FDA clarifies certain items in the seventh addition such as:

Are dietary supplements and components of dietary supplements considered “food” for purposes of the food facility registration requirement?
Yes. Under section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)), a dietary supplement and a component of a dietary supplement are “foods.” Accordingly, a facility that manufactures/processes, packs, or holds a dietary supplement or a component of a dietary supplement is required to register as a food facility unless it qualifies for an exemption from registration (21 CFR 1.226). Products marketed as nutritional supplements or feed supplements for animals are considered to be “foods” or “new animal drugs” depending on the intended use. Facilities manufacturing/processing, packing, or holding animal food for consumption in the United States must 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, Contains Nonbinding Recommendations 26 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.

We produce enzymes that can be used to manufacture food additives. Are the facilities in which these enzymes are manufactured/processed, packed or held subject to these regulations?
The answer to this question depends upon the use of the enzymes in question. As explained in Question C.2.5 in this document, for the purposes of food facility registration, the definition of “food” excludes food contact substances (21 CFR 1.227). If an enzyme produced by the facility is added to food and is intended to have a technical effect in the food, the facility is required to register. If the manufactured enzymes are used to manufacture a substance that will be a food contact substance (or component of a food contact substance), the facility is not required to register.

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 Contains Nonbinding Recommendations 27 201(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 food packaging required to register as food facilities?
No. The definition of “food” in 21 CFR 1.227, for the purposes of food facility registration, excludes food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)). Consequently, a facility that manufactures/processes, packs, or holds food contact substances, including food packaging or bottled water containers or closures, is not required to register.

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 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.

Do holding facilities need to register?

If finished food products for consumption in the United States are held at a third party facility before consolidation for import into the United States, must this facility register?
Yes. The facility is holding food for consumption in the United States, and therefore is required to register, unless an exemption applies (21 CFR 1.225 and 1.226).

Are foreign storage facilities that hold finished food products prior to export to the United States required to register?
Yes. Generally, a foreign storage facility that holds food prior to export to the United States is required to register with FDA. However, if the food subsequently undergoes manufacturing/processing of more than a de minimis nature in another foreign facility, the foreign storage facility prior to that manufacturing/processing facility is not required to register.

Do the facilities of both the exporter and the importer of food for consumption in the United States need to register if they each hold food?
Yes. The facilities of both the exporter and the importer are required to register if they hold food for consumption in the United States. However, as indicated in the response to Question C.3.5 in this document, the foreign facility need not register if all of the food held by that facility undergoes further manufacturing/processing of more than a de minimis nature in another facility outside the United States (21 CFR 1.226(a)).

Must I register my facility as a warehouse if we only hold food for a short period of time (i.e., a few hours to one day before food is transported)?
There is no timeframe (maximum or minimum) associated with holding. Consequently, a facility that holds food for consumption in the United States is not exempt from food facility registration requirements based on how long it holds food.

What is considered a trade name?

Does a distributor of food products need to register the trade names of all products it distributes, or repacks and then distributes, or only the trade names of those products manufactured at its facility?
Under 21 CFR 1.227, a “trade name” is a name under which a facility conducts business, as opposed to a “brand name,” which is a name associated with a product. A distributor is required to include in a facility’s registration all trade names under which the facility conducts business (21 CFR 1.232(a)(5)). A facility’s registration is not required to include all brand names for products manufactured/processed, packed, or held at the facility.

What is a U.S. agent for the purposes of the FDA registration?

Who can be a U.S. agent and what are the roles and responsibilities of the U.S. agent?
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.

For foreign facilities, may the U.S. agent for the facility also serve as the facility’s emergency contact?
Yes. The U.S. agent will be considered the emergency contact for a registered foreign facility unless another name is provided in the facility’s registration as the emergency contact (21 CFR 1.227 and 1.232(c)).

I am a foreign facility that does business with several different brokers. May I use more than one of these as my U.S. agent?
No. 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).

May a foreign food processor change U.S. agents after registration?
Yes. A foreign facility may change its U.S. agent at any time. Under 21 CFR 1.234(a), updates to required information, including the U.S. agent designation by foreign facilities, must be made within 60 calendar days of the change. At this time, updates may be submitted electronically at https://www.access.fda.gov. If you do not have access to the Internet, you also may update the U.S. agent information through the paper system, as explained in section II.E.3 in this document. After January 4, 2020, you must submit updates electronically, unless FDA has granted a waiver under 21 CFR 1.245 (see also section II.N of this document for a discussion on waivers).

What information must the U.S. agent have on the foreign facility?
For example, does the U.S. agent need to know and understand the company and product? Or is it sufficient for the U.S. agent to be able to contact the manufacturer quickly in case of emergency, as well as serve as a conduit for the general information flow to and from FDA? Under 21 CFR 1.227, there are two qualifications for a U.S. agent. The agent: (1) must reside or maintain a place of business in the United States; and (2) must be physically present in the United States. Although the U.S. agent is not required to know and understand the facility’s company and product, the U.S. agent must be able to serve as the communication link between FDA and the foreign facility because FDA will contact the foreign facility’s U.S. agent when an emergency occurs (unless the registration specifies another emergency contact). Thus, at a minimum, the U.S. agent needs to know whom to contact at the facility if any emergency arises.

How does a foreign facility “authorize” someone in the United States to be their agent (e.g., letter to FDA, notarized document)?
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).

May a foreign facility appoint one U.S. agent for part of the year and another U.S. agent for the rest of the year?
Yes. However, any change in a facility’s U.S. agent must be communicated to FDA through an update of the registration information within 60 days of the change (21 CFR 1.234).

Under 21 CFR 1.232(c), the registration for a foreign facility is required to include the “name, full address, phone number, and e-mail address of the foreign facility’s U.S. agent. . . .” “U.S. agent” is defined in 21 CFR 1.227 as a “person . . . residing or maintaining a place of business in the United States whom a foreign facility designates as its agent” for purposes of registration of food facilities. As used in this definition, what does a facility need to do to “designate” a person as a U.S. agent?
A foreign facility’s U.S. agent must reside or maintain a place of business in the United States and must be physically present in the United States (21 CFR 1.227). FDA expects the facility management to contact the person and confirm that the person is willing and able to serve as the facility’s U.S. agent. The facility should “designate” a person as the facility’s U.S. agent only if the person has affirmatively agreed to serve in that capacity. The person’s name and other identifying information must be given in section 7 of Form FDA 3537 or in response to the appropriate prompt when a facility is registered electronically. As previously stated in our response to Question C.7.10, 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).

What will happen to an article of food that is offered for import into the United States from a facility that does not provide a U.S. agent?
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.

What will happen to an article of food that is offered for import into the United States from a facility that does not provide a U.S. agent?
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.

Can the U.S. agent for food facility registration and the U.S. agent for purposes of the FSVP be the same person?
Yes. There is no prohibition on the same person serving as both the U.S. agent for purposes of food facility registration and the U.S. agent for purposes of satisfying the FSVP “importer” requirements–provided that such person meets the relevant requirements of both the FSVP Contains Nonbinding Recommendations 36 regulation (21 CFR part 1, subpart L) and the food facility registration regulation.

Can the U.S. agent for a foreign food facility access the facility’s registration via FDA Unified Registration and Listing Systems (FURLS)/Food Facility Registration Module (FFRM) and help desk on behalf of the foreign facility?
Yes. The U.S. agent of a foreign facility can view the information submitted in the foreign facility’s registration (21 CFR 1.227). The U.S. agent will be able to view the information electronically via FURLS/FFRM. U.S. agents can contact FDA’s help desk with questions about foreign facilities that they represent. In addition, a U.S. agent may contact FDA’s help desk on behalf of the foreign facility (see Comment 25 in the Registration Final Rule; 81 FR 45912 at 45927).

When must the facility register and renew their FDA registration?

When must you register initially under the food facility registration requirements?
If you are required to register with FDA, you must register before your facility begins manufacturing/processing, packing, or holding operations.

When does a facility that is required to register with FDA need to submit a registration renewal to FDA?
Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations every other year, during the period beginning on October 1 and ending Contains Nonbinding Recommendations 37 on December 31 of each even-numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required (21 CFR 1.241(b)). FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 (21 CFR 1.241(b)). The failure to register a food facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)).

Do new food facilities need to wait until October 1 of a biennial renewal year to register?
No. The owner, operator, or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the United States must register before the facility begins such activities (21 CFR 1.230). An owner, operator, or agent in charge of a facility may authorize an individual to register the facility on its behalf (21 CFR 1.230). If the initial registration is submitted prior to October 1 of a biennial renewal year, a renewal still must be submitted for the facility during the period beginning on October 1 and ending on December 31.

Does FDA intend to inform food facilities about the registration renewal period?
Prior to the beginning of the biennial registration renewal (or “registration renewal”) period on October 1, FDA intends to communicate with all registered facilities and U.S. agents for the facilities notifying them of the upcoming registration renewal period. In these communications, 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 communications 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.

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).

How can I submit my registration or registration renewal electronically?
You, or an individual you authorize, can submit a facility’s registration or registration renewal electronically via FURLS Food Facility Registration Module (FFRM) at https://www.access.fda.gov. You will need an FDA Industry Systems (FIS) account ID and password in order to access the electronic system.

Unique facility identifier number

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. As outlined in 21 CFR 1.231(a)(3) and (b)(5), beginning October 1, 2020, FDA intends to conduct the verification process for the UFI as follows:

Which UFI or UFIs are recognized as acceptable to FDA for food facility registration purposes?
At this time, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet. However, as stated previously in this document, the requirement to submit a UFI will not begin until October 1, 2020. If FDA recognizes as acceptable any additional UFIs before the October 1, 2020 date, we will update the response to this question.

How do I obtain a UFI recognized as acceptable by FDA?
At this time, the DUNS number is the preferred UFI recognized as acceptable to FDA for food facility registration. The DUNS number is assigned and managed by Dun & Bradstreet and is available free of charge. Information on how to obtain a DUNS number will be available on the FDA Web site. https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006832.htm

You can obtain a DUNS number through the Internet or by phone. However, the requirement to submit a UFI will not begin until October 1, 2020. If FDA recognizes as acceptable additional UFIs before the October 1, 2020 date, we will update the response to this question.

How and when do you update your facility’s registration information?

When must I update the information submitted in a food facility’s registration?
You, or an individual you authorize, must submit an update to the facility’s registration within 60 calendar days of any change to any of the required information (21 CFR 1.234(a)). If the reason for an update is a change in ownership, the former owner must cancel the facility’s registration within 60 calendar days. The new owner must submit a new registration for the facility before the facility begins to manufacture/process, pack, or hold food for consumption in the United States (21 CFR 1.234(b)).

I have changes to my registration information. Must I update my registration now, or can I wait until the beginning of the biennial registration renewal period beginning on October 1 of each even-numbered year?
The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s registration to FDA within 60 calendar days of a change to any of the required registration information previously submitted under 21 CFR 1.232 (21 CFR 1.234(a)). If a change occurs to a facility’s previously submitted required registration information before the start of or during the biennial registration renewal period, a registrant may submit an update for such change as part of the facility’s registration renewal by including the update information in the registration renewal, provided that such update is submitted within 60 calendar days of the change. If a facility submits an update to FDA before the start of the next biennial registration renewal period, which takes place from October 1 – December 31 of each even-numbered year, the facility will still be required to submit a registration renewal to FDA during the biennial registration renewal period.

If I am the owner, operator, or agent in charge of a facility, may I authorize another individual to update the facility’s registration?
Yes. Under 21 CFR 1.234(a), the owner, operator, or agent in charge of a facility may authorize an individual to update a facility’s registration. The authorized individual may be, but is not required to be, the U.S. agent for the facility. For updates not submitted by the owner, operator, or agent in charge, the update must include the email address of the individual who authorized the update, unless FDA has granted a waiver under 21 CFR 1.235 (21 CFR 1.234(a)). FDA will verify that the individual identified as having authorized submission of the update in fact authorized the submission on behalf of the facility and will not confirm the registration update until that individual confirms that he or she authorized the update (21 CFR 1.234(c)(3); 21 CFR 1.234(d)(6)).

How and when must a facility cancel its registration?
The owner, operator, or agent in charge of the facility, or an individual authorized by one of them, must cancel the registration within 60 calendar days of the reason for the cancellation (e.g., if a facility goes out of business or comes under new ownership, the owner, operator, or agent in charge must cancel the registration within 60 days (21 CFR 1.235)).

Can FDA cancel my registration?
Yes. As described in 21 CFR 1.241(c), FDA may cancel registrations in certain circumstances. Specifically, 21 CFR 1.241(c) provides that FDA will cancel a registration if FDA independently verifies:

  • the facility is no longer in business;
  • the facility has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration;
  • the registration is for a facility that does not exist;
  • the facility is not required to register;
  • the information about the facility’s address was not updated in a timely manner in accordance with 21 CFR 1.234(a); or
  • the registration was submitted to FDA by a person not authorized to submit the registration under 21 CFR 1.225.

If FDA cancels my registration, will I be informed before the registration is canceled?
We anticipate that in many cases it will be appropriate for FDA to send notices to facilities facing potential cancellation indicating our intent to cancel their registrations and the basis for such cancellations. We also anticipate that, when appropriate, if the circumstances meriting possible cancellation are corrected within 30 days after notice is provided, we will not cancel the registration. We further anticipate that if facilities do not respond within 30 days, or if corrective action is otherwise not taken within that time period, we will consider the lack of response or lack of corrective action as independent verification that the facility should no longer be registered and will then cancel the registration. If a facility believes its registration was cancelled in error, the facility may contact FDA. We also anticipate that it will generally not be appropriate to provide the 30-day window for corrective action if the basis for cancellation is an expired registration due to failure to renew a registration in accordance with 21 CFR 1.230(b). In those circumstances, a facility would have already received notice of its obligation to renew. Leading up to and throughout the registration renewal period, we plan to notify registrants of their obligation to renew registrations and the deadline for doing so. We also plan to notify registrants that failure to renew their registrations in accordance with 21 CFR 1.230(b) will cause FDA to consider the registrations expired. Additionally, we plan to notify registrants that we will consider a food facility with an expired registration to have failed to register in accordance with section 415 of the FD&C Act. If FDA cancels a facility’s registration, FDA will send a confirmation of the cancellation to the facility (see 21 CFR 1.241(c)).

What are the consequences if an owner, operator, or agent in charge of a facility does not register, renew, update, or cancel the facility’s registration, as required in section 415 of the FD&C Act and 21 CFR part 1, subpart H?
If a facility is required to register under section 415 of the FD&C Act, then the failure of an owner, operator, or agent in charge of a facility to register its facility, renew the registration of its facility, update required registration elements of its facility’s registration, or to cancel its registration in accordance with the requirements in 21 CFR part 1, subpart H is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). See 21 CFR 1.241(a). 55 States can bring a civil action in Federal court to enjoin a person who commits a prohibited act. The United States also can bring a criminal action in Federal court to prosecute a person who is responsible for the commission of a prohibited act (21 CFR 1.241(a)). In addition, under section 306 of FD&C Act, FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. If food being imported or offered for import into the United States is from a foreign facility for which registration has not been submitted, the food must be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered. However, the food may be directed to a secure facility by FDA and/or U.S. Customs and Border Protection (CBP) (section 801(l) of the FD&C Act).

If a foreign facility has not renewed its registration by December 31 of a biennial renewal period, will the facility still be able to import food into the United States?
If a foreign facility required to register does not renew its registration by December 31 of a biennial renewal period, the registration for the facility will be considered expired and FDA will cancel the registration. FDA will enforce the registration requirements of section 415 of the FD&C Act and implementing regulations in 21 CFR part 1, subpart H as appropriate in each situation. FDA’s prior notice for imported foods system is the agency’s primary tool for ensuring that foreign facilities that offer food for import into the United States are registered under section 415 of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002). If FDA determines that a foreign food facility is not registered in accordance with section 415 and 21 CFR part 1, subpart H, including because the facility has failed to renew its registration as required, the food being imported or offered for import into the United States from the foreign facility is subject to being held at the port of entry (as defined in 19 CFR 101.1), in accordance with section 801(l) of the FD&C Act, unless CBP concurrence is obtained for the export of the food and the food is immediately exported from the port of arrival (as defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this circumstance shall not be entered and shall not be delivered to the importer, owner, or ultimate consignee until the foreign facility is registered in accordance with section 415 and 21 CFR part 1, subpart H, and the appropriate registration number is provided in prior notice as specified in 21 CFR 1.285(i). FDA may allow the food held at the port of entry to be moved to a secure facility, as appropriate (21 CFR 1.285(c)(2)). However, FDA ordinarily will not allow the food to be transferred by any person from the port of entry into the United States or from the secure facility.

Is my food registration information available to the public?

Is the information included in a food facility’s registration or relating to such registrations (e.g., list of registered facilities) available to the public?
Section 415(a)(5) of the FD&C Act provides that the list of registered facilities and registration documents, including information provided in those documents, that is submitted under 21 CFR part 1, subpart H, are not subject to public disclosure under the Freedom of Information Act (FOIA) (5 U.S.C. 552). In addition, any information derived from such list or registration documents that would disclose the identity or location of a specific registered person is not subject to disclosure under 5 U.S.C. 552.

Is a registered facility responsible for ensuring that the companies with which they deal are registered?
There are no direct penalties for doing business with a company that is not registered. However, if a company offers food for import into the United States and the food is from a foreign manufacturing facility that is not registered, the company may be unable to complete the prior notice for the shipment (21 CFR 1.281(a)(6)), which is required to import the shipment.

FDA also released a supplemental draft guidance to the seventh edition which includes questions and answers that clarify the FDA’s position about the registration requirements in situations in which multiple entities are involved in the use of shared physical space. These situations include when manufacturers lease their facility, store food at self-storage warehouses, or use commercial communal kitchens that are also used by other manufacturers to process food. FDA intends to incorporate the questions and answers in this supplemental draft guidance into future editions of the food facility registration guidance.

In addition to these documents the FDA also released a small entity compliance guidance in May 2018 to help smaller facilities understand and meet their registration requirements under the FD&C Act.

As a reminder, the 2018 biennial registration renewal period begins October 1st and concludes December 31st. To register or find more information about registration, owners and operators of facilities should visit the Registration of Food Facilities page at FDA.gov.

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