If you manufacture food and aren’t a farm or a USDA governed facility, it’s likely you’ve registered, or in creating your business may have questions about registering, your facility with the FDA under the requirements for registration in the Bioterrorism Act and Food Safety Modernization Act.

To help in the process of registration, the FDA regularly updates it’s Q&A’s and the 7th Edition of the FDA’s Questions and Answers Regarding Food Facility Registration is on its way; the agency has requested public comment through February. This update will include some helpful question and answer topics regarding registration that will be helpful, such as:

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).

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 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)).

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 at http://www.access.fda.gov

You may also use the electronic system to update your registration information or submit a cancellation (e.g., due to change in ownership or going out of business).

Do I submit registration information about the ingredients used at my facility for manufacturing finished foods, or the finished products that I manufacture?

You are required to provide the applicable food product categories of any food manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537 (21 CFR 1.232(a)(7)). If you are a manufacturer/processor, you should provide food product category information about the foods that you manufacture/process, not the ingredients that you use in your manufacturing/processing. For example, if you manufacture chocolate chip cookies and you use butter as one of the ingredients for the cookies, you should not provide food product category information about the butter. Instead, you should provide food product category information about the cookies. Specifically, you should select the food product category of bakery products, dough mixes, or icings. (See also the Food Product Categories Guidance at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm for more information and updates to the food product categories identified on Form FDA 3537.)

Am I required to provide activity type information in my registration submission?

Yes. Your food facility registration must include information about the type of activity conducted at your facility for each food product category identified (21 CFR 1.232(a)(8)). The activity type options are as follows:

  • Ambient human food storage warehouse/holding facility;
  • Refrigerated human food warehouse/holding facility;
  • Frozen human food warehouse/holding facility;
  • Interstate conveyance caterer/catering point;
  • Contract sterilizer;
  • Labeler/relabeler;
  • Manufacturer/processor;
  • Acidified food processor;
  • Low-acid food processor;
  • Farm mixed-type facility;
  • Packer/repacker;
  • Salvage operator (reconditioner);
  • Animal food warehouse/holding facility;
  • Other activity.

 

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?

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). The United 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).

When must I comply with the requirements of the Amendments to Registration of Food Facilities final rule?

You must comply with the requirements of the Registration Final Rule on September 12, 2016, unless otherwise stated in the final rule.

When must I comply with the UFI requirement?

Beginning October 1, 2020, you must provide the facility’s UFI recognized as acceptable by FDA in your registration submission, as specified in 21 CFR 1.232(a)(2).

When must I comply with the electronic submission requirement?

Beginning January 4, 2020, you must submit your registration, registration renewal, updates, and cancellations to FDA electronically unless FDA has granted a waiver from such requirement (see 21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)). Furthermore, as we stated in the Registration Final Rule, FDA must have already granted a waiver in order for the electronic submission requirement to not apply (see 81 FR 45912 at 45943 to 45944).

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