CFR Subpart H

CFR Subpart H
in effect

21 C.F.R. § 1.240 What other registration requirements apply?

In addition to the requirements of this subpart, you must comply with the registration regulations found in part 108 of this chapter, related to emergency permit control, and any other Federal, State, or local registration requirements that apply to your facility.

21 C.F.R. § 1.241 What are the consequences of failing to register, update, renew, or cancel your registration?

(a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332), the United States can bring a civil action in Federal court to enjoin a person who commits a prohibited act. Under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the United States can bring a criminal action in Federal court to prosecute a person who is responsible for the commission of a prohibited act. Under section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a), FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. Failure of an owner, operator, or agent in charge of a domestic or foreign facility to register its facility, renew the registration of its facility, update required elements of its facility's registration, or cancel its registration in accordance with the requirements of this subpart is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act. (b) FDA will consider a registration for a food facility to be expired if the registration is not renewed, as required by § 1.230(b). Thus, if you previously submitted a registration to FDA, but do not submit a registration renewal to FDA during the period beginning on October 1 and ending on December 31 of each even-numbered year, FDA will consider the registration for the facility to be expired. FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act. (c) FDA will cancel a registration if FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility's address was not updated in a timely manner in accordance with § 1.234(a) or the registration was submitted by a person not authorized to submit the registration under § 1.225. Also, FDA will cancel a registration if the facility's registration has expired because the facility has failed to renew its registration in accordance with § 1.230(b). If FDA cancels a facility's registration, FDA will send a confirmation of the cancellation using contact information submitted by the facility in the registration database. (d) If an article of food is imported or offered for import into the United States and a foreign facility that manufactured/processed, packed, or held that article of food has not registered in accordance with this subpart, the disposition of the article of food shall be governed by the procedures set out in subpart I of this part.

21 C.F.R. § 1.242 What does assignment of a registration number mean?

Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way convey FDA's approval or endorsement of a facility or its products.

21 C.F.R. § 1.243 Is food registration information available to the public?

(a) The list of registered facilities and registration documents submitted under this subpart are not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information Act). 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 (the Freedom of Information Act). (b) Paragraph (a) of this section does not apply to any information obtained by other means or that has previously been disclosed to the public as defined in § 20.81 of this chapter.

21 C.F.R. § 1.245 Waiver request.

Under §§ 1.231(a)(2) and (b), 1.234(d), and 1.235(d), 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. Under § 1.232(a)(6), you must provide the email address of the owner, operator, or agent in charge of the facility unless FDA has granted a waiver from such requirement. In addition, under §§ 1.230(b) and (c), 1.232(a)(10), 1.234(a), and 1.235(b)(5), registration renewals, abbreviated registration renewals, registrations, updates, and cancellations not submitted by the owner, operator, or agent in charge must include the email address for the individual who authorized the submission, unless FDA has granted a waiver. To request a waiver from these requirements, you must submit a written request to FDA that explains why it is not reasonable for you to submit your registration, registration renewal, update, or cancellation to FDA electronically or to provide the email address of the owner, operator, or agent in charge of the facility. You must submit your request to: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740.

21 C.F.R. § 1.230 When must you register or renew your registration?

(a) Registration. You must register before your facility begins to manufacture, process, pack, or hold food for consumption in the United States. You may authorize an individual to register the facility on your behalf. (b) Registration renewal. You must submit a registration renewal containing the information required under § 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. You may authorize an individual to renew a facility's registration on your behalf. If the individual submitting the registration renewal is not the owner, operator, or agent in charge of the facility, the registration renewal must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration renewal, and identifies by name, address, and telephone number, the individual who authorized submission of the registration renewal. In addition, the registration renewal must also identify the individual who authorized submission of the registration renewal by email address, unless FDA has granted a waiver under § 1.245. Each registration renewal must include the name of the individual submitting the registration renewal, and the individual's signature (for the paper option). Each electronic registration renewal must include the name of the individual submitting the renewal. (c) Abbreviated registration renewal process. If you do not have any changes to the information required under § 1.232 since you submitted the preceding registration, registration renewal, or update for your facility, you may use the abbreviated registration renewal process. If you use the abbreviated registration renewal process, you must confirm that no changes have been made to the information required under § 1.232 since you submitted the preceding registration, registration renewal or update, and you must certify that the information submitted is truthful and accurate. Each abbreviated registration renewal must include the name of the individual submitting the abbreviated renewal, and the individual's signature (for the paper option). Each electronic abbreviated registration renewal must include the name of the individual submitting the abbreviated renewal. For abbreviated registration renewals not submitted by the owner, operator, or agent in charge of the facility, the abbreviated renewal must provide the email address of the individual who authorized submission of the abbreviated renewal, unless FDA has granted a waiver under § 1.245. You must use Form FDA 3537 to submit abbreviated registration renewals to FDA.

21 C.F.R. § 1.231 How and where do you register or renew your registration?

(a) Electronic registration and registration renewal. (1) To register or renew a registration electronically, you must go to http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. An individual authorized by the owner, operator, or agent in charge of a facility may also register a facility electronically. (2) Beginning on January 4, 2020, you must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under § 1.245. (3) After you submit your electronic registration, FDA will verify the accuracy of your unique facility identifier (UFI) recognized as acceptable by FDA and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. With respect to electronic registration renewals, after you submit your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update your facility's UFI as part of your electronic registration renewal, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with a confirmation of your registration renewal until FDA verifies the accuracy of your UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. (4) For electronic registrations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration, FDA will verify that the individual identified as having authorized submission of the registration in fact authorized the submission on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the submission. With respect to electronic registration renewals, after completion of the electronic registration renewal, FDA will provide an electronic confirmation of the registration renewal. For electronic registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will verify that the individual identified as having authorized submission of the registration renewal in fact authorized the submission on behalf of the facility. FDA will not provide an electronic confirmation of the registration renewal until that individual confirms that he or she authorized the submission. (5) For a foreign facility, after you submit your electronic registration, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to electronic registration renewals, after you complete your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update information about your U.S. agent as part of your electronic registration renewal, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent. (6) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234. (7) You will be considered registered once FDA electronically sends you your confirmation and registration number. (b) Registration or registration renewal by mail or fax. Beginning January 4, 2020, you must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted you a waiver under § 1.245, you may register or renew a registration by mail or by fax. (1) You must register or renew a registration (including abbreviated registration renewals) using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156. (2) When you receive the form, you must fill it out completely and legibly and either mail it to the address in paragraph (b)(1) of this section or fax it to 301-436-2804. (3) If any required information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax). (4) FDA will enter complete and legible mailed and faxed registration submissions into its registration system, as soon as practicable, in the order FDA receives them. (5) After you submit your registration, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. With respect to registration renewals, after you submit your registration renewal by mail or fax, FDA will provide you with a confirmation of your registration renewal. When you update your facility's UFI as part of your registration renewal, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with a confirmation of your registration renewal until FDA verifies the accuracy of your UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. (6) For registrations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration by mail or fax, FDA will verify that the individual identified as having authorized submission of the registration in fact authorized the submission on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the submission. With respect to registration renewals, after completion of the registration renewal by mail or fax, FDA will provide a confirmation of the registration renewal. For registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will verify that the individual identified as having authorized submission of the registration renewal in fact authorized the submission on behalf of the facility. FDA will not provide a confirmation of the registration renewal until that individual confirms that he or she authorized the submission. (7) For a foreign facility, after you submit your registration by mail or fax, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to registration renewals, after you complete your registration renewal by mail or fax, FDA will provide you with a confirmation of your registration renewal. When you update information about your U.S. agent as part of your registration renewal, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with a confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent. (8) FDA will mail or fax you a copy of the registration as entered, confirmation of registration, and your registration number. When responding to a registration submission, FDA will use the means by which the registration was received by the Agency (i.e., by mail or fax). (9) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234. (10) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number. (c) Fees. No registration fee is required. (d) Language. You must submit all registration information in the English language except an individual's name, the name of a company, the name of a street, and a trade name may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet.

21 C.F.R. § 1.232 What information is required in the registration?

(a) For a domestic and foreign facility, the following information is required: (1) The name, full address, and phone number of the facility; (2) Beginning October 1, 2020, the facility's UFI recognized as acceptable by FDA; (3) The preferred mailing address, if different from that of the facility; (4) The name, full address, and phone number of the parent company, if the facility is a subsidiary of the parent company; (5) All trade names the facility uses; (6) The name, full address, and phone number of the owner, operator, or agent in charge of the facility. In addition, the email address of the owner, operator, or agent in charge is required, unless FDA has granted you a waiver under § 1.245; (7) The applicable food product categories of any food manufactured/processed, packed, or held at the facility as identified on Form FDA 3537; (8) The type of activity conducted at the facility for each food product category identified. You may select more than one activity type for each food product category identified. The activity type options are as follows: (i) Ambient human food storage warehouse/holding facility; (ii) Refrigerated human food warehouse/holding facility; (iii) Frozen human food warehouse/holding facility; (iv) Interstate conveyance caterer/catering point; (v) Contract sterilizer; (vi) Labeler/relabeler; (vii) Manufacturer/processor; (viii) Acidified food processor; (ix) Low-acid food processor; (x) Farm mixed-type facility; (xi) Packer/repacker; (xii) Salvage operator (reconditioner); (xiii) Animal food warehouse/holding facility; (xiv) Other activity. (9) A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act; (10) A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. In addition, the registration must identify the individual who authorized submission of the registration by email address, unless FDA has granted a waiver under § 1.245. Each registration must include the name of the individual submitting the registration, and the individual's signature (for the paper option). (b) For a domestic facility, the following additional information is required: (1) The email address for the contact person of the facility; (2) An emergency contact phone number and email address if different from the email address for the contact person in paragraph (b)(1) of this section. (c) For a foreign facility, the following additional information is required: (1) The name, full address, phone number, and email address of the foreign facility's U.S. agent; (2) An emergency contact phone number and email address.

21 C.F.R. § 1.233 Are there optional items included in the registration form?

Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.

21 C.F.R. § 1.234 How and when do you update your facility's registration information?

(a) Update requirements. You must update a facility's registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. You may authorize an individual to update a facility's registration on your behalf. For updates not submitted by the owner, operator, or agent in charge of the facility, the update must provide the email address of the individual who authorized submission of the update, unless FDA has granted a waiver under § 1.245. (b) Cancellation due to ownership changes. If the reason for the update is that the facility has a new owner, the former owner must cancel the facility's registration as specified in § 1.235 within 60 calendar days of the change and the new owner must submit a new registration for the facility as specified in § 1.231. The former owner may authorize an individual to cancel a facility's registration. (c) Electronic update. (1) To update your registration electronically, you must update at http://www.fda.gov/furls. (2) After you submit your electronic update, FDA will provide you with an electronic confirmation of your update. When updating UFI information, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with an electronic confirmation of your registration update until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. For foreign facilities, when updating information about your U.S. agent, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration update until that person confirms that the person agreed to serve as your U.S. agent. (3) For electronic updates not submitted by the owner, operator, or agent in charge of the facility, after submission of the electronic update, FDA will verify that the individual identified as having authorized submission of the update in fact authorized the submission on behalf of the facility. FDA will not confirm the update to the registration until that individual confirms that he or she authorized the submission. (4) Your registration will be considered updated once FDA sends you your update confirmation, unless notified otherwise. (d) Update by mail or fax. Beginning January 4, 2020, you must submit your update electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted you a waiver under § 1.245, you may update your facility's registration by mail or by fax. (1) You must update your registration using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156. (2) When you receive the form, you must legibly fill out the sections of the form reflecting your updated information and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804. (3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the registration was received by the Agency (i.e., by mail or fax). (4) FDA will enter complete and legible updates into its registration system as soon as practicable, in the order FDA receives them. (5) FDA will then mail to the address or fax to the fax number on the registration form a copy of the update as entered and confirmation of the update. When responding to an update submission, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax). After you submit your update by mail or fax, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide a confirmation of your registration update until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. For foreign facilities, when updating information about your U.S. agent, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with a confirmation of your registration update until that person confirms that the person agreed to serve as your U.S. agent. (6) For registration updates not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration update by mail or fax, FDA will verify that the individual identified as having authorized submission of the update in fact authorized the submission on behalf of the facility. FDA will not confirm the registration update until that individual confirms that he or she authorized the update. (7) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update. (8) Your registration will be considered updated once FDA enters your facility's update data into the registration system and the system generates an update confirmation.

21 C.F.R. § 1.235 How and when do you cancel your facility's registration information?

(a) Notification of registration cancellation. You must cancel a registration within 60 calendar days of the reason for cancellation (e.g., your facility ceases operations, ceases providing food for consumption in the United States, or is sold to a new owner). (b) Cancellation requirements. The cancellation of a facility's registration must include the following information: (1) The facility's registration number; (2) Whether the facility is domestic or foreign; (3) The facility name and address; (4) The name, address, and email address (if available) of the individual submitting the cancellation; (5) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, the email address of the individual who authorized submission of the registration cancellation, unless FDA has granted a waiver under § 1.245; and (6) A statement certifying that the information submitted is true and accurate, and that the person submitting the cancellation is authorized by the facility to cancel its registration. (c) Electronic cancellation. (1) To cancel your registration electronically, you must cancel at http://www.fda.gov/furls. (2) Once you complete your electronic cancellation, FDA will provide you with an electronic confirmation of your cancellation. (3) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration cancellation, FDA will verify that the individual identified as having authorized submission of the cancellation in fact authorized the submission on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation. (4) Your registration will be considered cancelled once FDA sends you your cancellation confirmation. (d) Cancellation by mail or fax. Beginning January 4, 2020, you must cancel your registration electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted a waiver under § 1.245, you may cancel your facility's registration by mail or fax. (1) You must cancel your registration using Form FDA 3537a. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156. (2) When you receive the form, you must completely and legibly fill out the form and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804. (3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a cancellation form for revision, FDA will use the means by which the cancellation was received by the Agency (i.e., by mail or fax). (4) FDA will enter complete and legible mailed and faxed cancellations into its registration system as soon as practicable, in the order FDA receives them. (5) FDA will mail to the address or fax to the fax number on the cancellation form a copy of the cancellation as entered and confirmation of the cancellation. When responding to a cancellation, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax). (6) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration cancellation by mail or fax, FDA will verify that the individual identified as having authorized submission of the cancellation in fact authorized the submission on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation. (7) Your registration will be considered cancelled once FDA enters your facility's cancellation data into the registration system. FDA will send you your cancellation confirmation.

21 C.F.R. § 1.225 Who must register under this subpart?

(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for one of the exemptions in § 1.226. (b) 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. (c) 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.

21 C.F.R. § 1.226 Who does not have to register under this subpart?

This subpart does not apply to the following facilities: (a) A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. A facility is not exempt under this provision if the further manufacturing/processing (including packaging) conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature; (b) Farms; (c) Retail food establishments; (d) Restaurants; (e) Nonprofit food establishments in which food is prepared for, or served directly to, the consumer; (f) Fishing vessels, including those that not only harvest and transport fish but also engage in practices such as heading, eviscerating, or freezing intended solely to prepare fish for holding on board a harvest vessel. However, those fishing vessels otherwise engaged in processing fish are subject to this subpart. For the purposes of this section, “processing” means handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, holding, or heading, eviscerating, or freezing other than solely to prepare fish for holding on board a harvest vessel; (g) Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

21 C.F.R. § 1.227 What definitions apply to this subpart?

The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart: Calendar day means every day shown on the calendar. Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Nonbottled water drinking water collection and distribution establishments and their structures are not facilities. (1) Domestic facility means any facility located in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico that manufactures/processes, packs, or holds food for consumption in the United States. (2) Foreign facility means a facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the United States. Farm means: (1) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term “farm” includes operations that, in addition to these activities: (i) Pack or hold raw agricultural commodities; (ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1) of this definition; and (iii) Manufacture/process food, provided that: (A) All food used in such activities is consumed on that farm or another farm under the same management; or (B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of: (1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing); (2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and (3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or (2) Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in paragraphs (1)(ii) and (iii) of this definition. Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act: (1) Except for purposes of this subpart, it does not include: (i) Food contact substances as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act; or (ii) Pesticides as defined in 7 U.S.C. 136(u). (2) Examples of food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm. Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding. Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An 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. Nonprofit food establishment means a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)). Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives. Packing means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. “Restaurant” does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers. (1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and (2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants. Retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers 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. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations. A “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function. (1) Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers: (i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers); (ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and (iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs. (2) Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers: (i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers); (ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and (iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs. (3) For the purposes of this definition, “farm-operated business” means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s). Trade name means the name or names under which the facility conducts business, or additional names by which the facility is known. A trade name is associated with a facility, and a brand name is associated with a product. U.S. agent means a person (as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(e))) residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of this subpart. A U.S. agent may not be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's agent is not physically present. (1) The U.S. agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications. The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact. (2) 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. FDA will consider the U.S. agent the equivalent of the registrant for purposes of sharing information and communications. The U.S. agent of a foreign facility may view the information submitted in the foreign facility's registration. (3) Having a single U.S. agent for the purposes of this subpart does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. A firm's commercial business in the United States need not be conducted through the U.S. agent designated for purposes of this subpart. You or registrant means the owner, operator, or agent in charge of a facility that manufactures/processes, packs, or holds food for consumption in the United States.

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