US LAWS, STATUTES & CODES ON-LINE

Note: Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working hours 4,512/1,696=266 pct.

(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1 hour, and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than 1/2 hour.

(a) Scope. This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, and cosmetic exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act (the act) or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

(b) Recordkeeping requirements for human drugs, biological products, devices, animal drugs, foods, and cosmetics exported under or subject to section 801(e)(1) of the act. Persons exporting an article under section 801(e)(1) of the act or an article otherwise subject to section 801(e)(1) of the act shall maintain records as enumerated in paragraphs (b)(1) through (b)(4) of this section demonstrating that the product meets the requirements of section 801(e)(1) of the act. Such records shall be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product, except that records pertaining to the export of foods and cosmetics under section 801(e)(1) of the act shall be kept for 3 years after the date of exportation. The records shall be made available to the Food and Drug Administration (FDA), upon request, during an inspection for review and copying by FDA.

(1) Records demonstrating that the product meets the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;

(2) Records demonstrating that the product does not conflict with the laws of the importing country: This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of 18 U.S.C. 1001;

(3) Records demonstrating that the product is labeled on the outside of the shipping package that it is intended for export: This may consist of copies of any labels or labeling statements, such as “For export only,” that are placed on the shipping packages or, if the exported product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and

(4) Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials.

(c) Additional recordkeeping requirements for partially processed biological products exported under section 351(h) of the Public Health Service Act. In addition to the requirements in paragraph (b) of this section, persons exporting a partially processed biological product under section 351(h) of the Public Health Service Act shall maintain, for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product, and make available to FDA, upon request, during an inspection for review and copying by FDA, the following records:

(1) Records demonstrating that the product for export is a partially processed biological product and not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;

(2) Records demonstrating that the partially processed biological product was manufactured in conformity with current good manufacturing practice requirements;

(3) Records demonstrating the distribution of the exported partially processed biological products; and

(4) Copies of all labeling that accompanies the exported partially processed biological product and other records demonstrating that the exported partially processed biological product is intended for further manufacture into a final dosage form outside the United States; this may include a container label with the statement, “Caution: For Further Manufacturing Use Only” and any package insert.

(d) Notification requirements for drugs, biological products, and devices exported under section 802 of the act. (1) Persons exporting a human drug, biological product, or device under section 802 of the act, other than a drug, biological product, or device for investigational use exported under section 802(c) of the act, or a drug, biological product, or device exported in anticipation of marketing authorization under section 802(d) of the act, shall provide written notification to FDA. The notification shall identify:

(i) The product's trade name;

(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;

(iii) If the product is a drug or biological product, a description of the product's strength and dosage form or, if the product is a device, the product's model number; and

(iv) If the export is to a country not listed in section 802(b)(1) of the act, the country that is to receive the exported article. The notification may, but is not required to, identify countries listed in section 802(b)(1) of the act or state that the export is intended for a listed country without identifying the listed country.

(2) The notification shall be sent to the following addresses:

(i) For biological products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case Management (HFM–610), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448.

(ii) For human drug products, biological products, and devices regulated by the Center for Drug Evaluation and Research—Division of New Drugs and Labeling Compliance (HFD–310), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

(iii) For devices—Division of Program Operations (HFZ–305), Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850.

(e) Recordkeeping requirements for products subject to section 802(g) of the act. (1) Any person exporting a product under any provision of section 802 of the act shall maintain records of all drugs, biological products, and devices exported and the countries to which the products were exported. In addition to the requirements in paragraph (b) of this section, such records include, but are not limited to, the following:

(i) The product's trade name;

(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;

(iii) If the product is a drug or biological product, a description of its strength and dosage form and the product's lot or control number or, if the product is a device, the product's model number;

(iv) The consignee's name and address; and

(v) The date on which the product was exported and the quantity of product exported.

(2) These records shall be kept at the site from which the products were exported or manufactured, and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA.

[66 FR 65447, Dec. 19, 2001, as amended at 69 FR 48774, Aug. 11, 2004; 70 FR 14980, Mar. 24, 2005]

Source:  68 FR 58960, Oct. 10, 2003, unless otherwise noted.

General Provisions

(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.

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.);

(a) The act means the Federal Food, Drug, and Cosmetic Act.

(b) In addition, for the purposes of this subpart:

(1) Calendar day means every day shown on the calendar.

(2) 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.

(i) 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.

(ii) Foreign facility means a facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the United States.

(3) Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes:

(i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and

(ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

(4) Food has the meaning given in section 201(f) of the act (21 U.S.C. 321(f)),

(i) Except for purposes of this subpart, it does not include:

(A) Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)), or

(B) Pesticides as defined in 7 U.S.C. 136(u).

(ii) 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.

(5) Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

(6) 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 are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.

(7) 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)).

(8) Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives.

(9) Packing means placing food into a container other than packaging the food.

(10) 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.

(i) 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

(ii) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.

(11) Retail food establishment means an establishment that sells food products directly to consumers as its primary function. A retail food establishment may 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.

(12) 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.

(13) U.S. agent means a person (as defined in section 201(e) of the 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 cannot 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.

(i) 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 under §1.233(e) another emergency contact.

(ii) 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.

(iii) 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.

(14) 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.

The owner, operator, or agent in charge of a facility that manufactures/processes, packs or holds food for consumption in the United States must register the facility no later than December 12, 2003. 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 on or after December 12, 2003, must register before the facility begins such activities. An owner, operator, or agent in charge of a facility may authorize an individual to register the facility on its behalf.

(a) Electronic registration. (1) To register electronically, you must register at http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week. This website 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) FDA strongly encourages electronic registration for the benefit of both FDA and the registrant.

(3) Once you complete your electronic registration, FDA will automatically provide you with an electronic confirmation of registration and a permanent registration number.

(4) You will be considered registered once FDA electronically transmits your confirmation and registration number.

(b) Registration by mail or fax. If, for example, you do not have reasonable access to the Internet through any of the methods described in paragraph (a) of this section, you may register by mail or fax.

(1) You must register using Form 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857 or by requesting a copy of this 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 301–210–0247.

(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, along with CD-ROM submissions, 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 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).

(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) 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) Registration by CD-ROM for multiple submissions. If, for example, you do not have reasonable access to the Internet through any of the methods provided under paragraph (a) of this section, you may register by CD-ROM.

(1) Registrants submitting their registrations in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format.

(2) These files must be submitted on a portable document format (PDF) rendition of the registration form (Form 3537) and be accompanied by one signed copy of the certification statement that appears on the registration form (Form 3537).

(3) Each submission on the CD-ROM must contain the same preferred mailing address in the appropriate block on Form 3537.

(4) A CD-ROM may contain registrations for as many facilities as needed up to the CD-ROM's capacity.

(5) The registration on the CD-ROM for each separate facility must have a unique file name up to 32 characters long, the first part of which may be used to identify the parent company.

(6) You must mail the CD-ROM to the U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857.

(7) If FDA receives a CD-ROM that does not comply with these specifications, it will return the CD-ROM to the submitter unprocessed.

(8) FDA will enter CD-ROM submissions that comply with these specifications into its registration system, along with the complete and legible mailed and faxed submissions, as soon as practicable, in the order FDA receives them.

(9) For each facility on the CD-ROM, FDA will mail to the preferred mailing address a copy of the registration(s) as entered, confirmation of registration, and each facility's assigned registration number.

(10) 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.

(11) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.

(d) Fees. No registration fee is required.

(e) 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.

[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004]

Each registrant must submit the following information through one of the methods described in §1.231:

(a) The name, full address, and phone number of the facility;

(b) The name, address, and phone number of the parent company, if the facility is a subsidiary of the parent company;

(c) For domestic and foreign facilities, the names, addresses, and phone numbers of the owner, operator, and agent in charge.

(d) For a foreign facility, the name, address, phone number, and, if no emergency contact is designated under §1.233(e), the emergency contact phone number of the foreign facility's U.S. agent;

(e) For a domestic facility, an emergency contact phone number;

(f) All trade names the facility uses;

(g) Applicable food product categories as identified in §170.3 of this chapter, unless you check either “most/all human food product categories,” according to §1.233(j), or “none of the above mandatory categories” because your facility manufactures/processes, packs, or holds a food that is not identified in §170.3 of this chapter;

(h) The name, address, and phone number for the owner, operator, or agent in charge;

(i) 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. Each registration must include the name of the individual registering the facility submitting the registration, and the individual's signature (for the paper and CD-ROM options).

[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004]

FDA encourages, but does not require, you to submit the following items in your facility's registration. These data will enable FDA to communicate more quickly with facilities that may be the target of a terrorist threat or attack, or otherwise affected by an outbreak of foodborne illness. This information includes:

(a) Fax number and e-mail address of the facility;

(b) Preferred mailing address, if different from that of the facility;

(c) Fax number and e-mail address of the parent company, if the facility is a subsidiary of the parent company;

(d) For a domestic facility, emergency contact name, title, and e-mail address;

(e) For a foreign facility, an emergency contact name, title, phone number and e-mail address. FDA will consider the facility's U.S. agent the facility's emergency contact unless the facility chooses to designate another person to serve as an emergency contact under this section;

(f) For a foreign facility, title, fax number, and e-mail address of the U.S. agent;

(g) Type of activity conducted at the facility (e.g., manufacturing/processing or holding);

(h) Food categories not identified in §170.3 of this chapter, which are provided in Form 3537 sections 11a (e.g., infant formula, animal byproducts and extracts) and 11b (e.g., grain products, amino acids);

(i) Type of storage, if the facility is primarily a holding facility;

(j) A food product category of “most/all human food product categories,” if the facility manufactures/processes, packs, or holds foods in most or all of the categories identified in §170.3 of this chapter;

(k) Approximate dates of operation, if the facility's business is seasonal;

(l) The fax number and e-mail address of the owner, operator, or agent in charge; and

(m) The fax number and e-mail address of the individual who authorized submission of the registration.

(a) Update requirements. The owner, operator, or agent in charge must submit an update to 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. The owner, operator, or agent in charge may authorize an individual to update a facility's registration.

(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 re-register 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) Once you complete your electronic update, FDA will automatically provide you with an electronic confirmation of your update.

(3) Your registration will be considered updated once FDA transmits your update confirmation, unless notified otherwise.

(d) Update by mail or fax. If, for example, you do not have reasonable access to the Internet through any of the methods described in §1.231(a)), you may update your facility's registration by mail or by fax:

(1) You must update your registration using Form 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857 or by requesting the form by phone at 1–877–FDA–3882 (1–877–332–3882).

(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 301–210–0247.

(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, along with CD-ROM submissions, 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).

(6) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.

(7) 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.

(e) Update by CD-ROM for multiple submissions. If, for example, you do not have reasonable access to the Internet through any of the methods provided under §1.231(a), you may update your facilities' registrations by CD-ROM.

(1) Registrants submitting their updates in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format.

(2) Update files must be submitted on a PDF rendition of FDA's registration form (Form 3537) and be accompanied by one signed copy of the certification statement on the registration form (Form 3537).

(3) Each submission on the CD-ROM must contain the same preferred mailing address in the appropriate block on Form 3537.

(4) The CD-ROM may contain updates for as many facilities as needed up to the CD-ROM's capacity.

(5) The update for each facility on the CD-ROM must have a unique file name up to 32 characters long, the first part of which may be used to identify the parent company.

(6) You must mail the CD-ROM to U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857.

(7) If FDA receives an update CD-ROM that does not comply with these specifications, it will return the CD-ROM to the registrant unprocessed.

(8) FDA will enter CD-ROM update submissions into its registration system, along with the complete and legible mailed and faxed update submissions, as soon as practicable, in the order FDA receives them.

(9) For each facility on the CD-ROM, FDA will mail to the preferred mailing address a copy of the update(s) as entered and confirmation of the update.

(10) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.

(11) 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.

(a) Notification of registration cancellation. A facility canceling its registration must do so within 60 calendar days of the reason for cancellation (e.g., facility ceases operations, ceases providing food for consumption in the United States, or the facility 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 e-mail address (if available) of the individual submitting the cancellation; and

(5) 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 automatically provide you with an electronic confirmation of your cancellation.

(3) Your registration will be considered cancelled once FDA transmits your cancellation confirmation.

(d) Cancellation by mail or fax. If, for example, you do not have reasonable access to the Internet through any of the methods described in §1.231(a), you may cancel your facility's registration by mail or fax.

(1) You must cancel your registration using Form 3537a. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857, or by requesting the form by phone at 1–877–FDA–3882 (1–877–332–3882).

(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 301–210–0247.

(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, along with CD-ROM cancellations, 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 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) If any information you previously submitted was incorrect at the time of submission, you must immediately resubmit your cancellation.

(7) Your registration will be considered cancelled once FDA enters your facility's cancellation data into the registration system and the system generates a confirmation.

(e) Cancellation by CD-ROM for multiple submissions. If, for example, you do not have reasonable access to the Internet through any of the methods described in §1.231(a), you may cancel your facilities' registrations using a CD-ROM.

(1) Registrants submitting their cancellations in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format.

(2) Cancellation files must be submitted on a PDF rendition of the cancellation form (Form 3537a) and be accompanied by one signed copy of the certification statement on the cancellation form.

(3) Each submission on the CD-ROM must contain the same preferred mailing address in the appropriate block on Form 3537.

(4) The CD-ROM may contain cancellations for as many facilities as needed up to the CD-ROM's capacity.

(5) The cancellation for each facility on the CD-ROM must have a unique file name up to 32 characters long, the first part of which may be used to identify the parent company.

(6) You must mail the CD-ROM to U.S. Food and Drug Administration (HFS–681), 5600 Fishers Lane, Rockville, MD 20857.

(7) If FDA receives a CD-ROM that does not comply with these specifications, it will return the CD-ROM to the registrant unprocessed.

(8) FDA will enter CD-ROM submissions that meet the specifications into its registration system, along with complete and legible mailed and faxed submissions, as soon as practicable, in the order FDA receives them.

(9) For each facility on the CD-ROM, FDA will mail to the preferred mailing address a copy of the cancellation(s) as entered and confirmation of the cancellation.

(10) If any information you previously submitted was incorrect at the time of submission, you must immediately resubmit your cancellation.

(11) Your registration will be considered cancelled once FDA enters your facility's cancellation data into the registration system and the system generates a confirmation.

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.

(a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done. Under section 302 of the 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 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 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, to update required elements of it's facility's registration, or to cancel its registration in accordance with the requirements of this subpart is a prohibited act under section 301(dd) of the act.

(b) FDA will cancel a registration if the agency 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. If FDA cancels a facility's registration, FDA will mail a confirmation of the cancellation to the facility at the address provided in the facility's registration.

(c) 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.

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.

(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.

Source:  68 FR 59070, Oct. 10, 2003, unless otherwise noted.

General Provisions

(a) The act means the Federal Food, Drug, and Cosmetic Act.

(b) The definitions of terms in section 201 of the act (21 U.S.C. 321) apply when the terms are used in this subpart, unless defined below.

(1) Calendar day means every day shown on the calendar.

(2) Country from which the article originates means FDA Country of Production.

(3) Country from which the article is shipped means the country in which the article of food is loaded onto the conveyance that brings it to the United States or, in the case of food sent by international mail, the country from which the article is mail.

(4) FDA Country of Production means:

(i) For an article of food that is in its natural state, the country where the article of food was grown, including harvested or collected and readied for shipment to the United States. If an article of food is wild fish, including seafood that was caught or harvested outside the waters of the United States by a vessel that is not registered in the United States, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is in its natural state was grown, including harvested or collected and readied for shipment, in a Territory, the FDA Country of Production is the United States.

(ii) For an article of food that is no longer in its natural state, the country where the article was made; except that, if an article of food is made from wild fish, including seafood, aboard a vessel, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is no longer in its natural state was made in a Territory, the FDA Country of Production is the United States.

(5) Food has the meaning given in section 201(f) of the act,

(i) Except for purposes of this subpart, it does not include:

(A) Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)); or

(B) Pesticides as defined in 7 U.S.C. 136(u).

(ii) Examples of food include fruits, vegetables, fish, including seafood, 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.

(6) Grower means a person who engages in growing and harvesting or collecting crops (including botanicals), raising animals (including fish, which includes seafood), or both.

(7) International mail means foreign national mail services. International mail does not include express carriers, express consignment operators, or other private delivery services.

(8) No longer in its natural state means that an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.

(9) Port of arrival means the water, air, or land port at which the article of food is imported or offered for import into the United States, i.e., the port where the article of food first arrives in the United States. This port may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the United States Bureau of Customs and Border Protection (CBP).

(10) Port of entry, in sections 801(m) and 801(l) of the act, means the port of entry as defined in 19 CFR 101.1.

(11) Registration number refers to the registration number assigned by FDA under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1, subpart H.

(12) Shipper means the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States.

(13) United States means the Customs territory of the United States (i.e., the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico), but not the Territories.

(14) You means the person submitting the prior notice, i.e., the submitter, or the person transmitting prior notice information on behalf of the submitter, i.e., the transmitter.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]

(a) This subpart applies to all food for humans and other animals that is imported or offered for import into the United States for use, storage, or distribution in the United States, including food for gifts and trade and quality assurance/quality control samples, food for transshipment through the United States to another country, food for future export, and food for use in a U.S. Foreign Trade Zone.

(b) Notwithstanding paragraph (a), this subpart does not apply to:

(1) Food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States;

(2) Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States;

(3) Food that is imported then exported without leaving the port of arrival until export;

(4) Meat food products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);

(5) Poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and

(6) Egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

A prior notice for an article of food may be submitted by any person with knowledge of the required information. This person is the submitter. The submitter also may use another person to transmit the required information on his/her behalf. The person who transmits the information is the transmitter. The submitter and transmitter may be the same person.

(a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must be confirmed by FDA for review as follows:

(1) If the article of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival;

(2) If the article of food is arriving by land by rail, no less than 4 hours before arriving at the port of arrival;

(3) If the article of food is arriving by air, no less than 4 hours before arriving at the port of arrival; or

(4) If the article of food is arriving by water, no less than 8 hours before arriving at the port of arrival.

(b) Except in the case of an article of food imported or offered for import by international mail, you may not submit prior notice more than 5 calendar days before the anticipated date of arrival of the food at the anticipated port of arrival.

(c) Notwithstanding paragraphs (a) and (b) of this section, if the article of food is arriving by international mail, you must submit the prior notice before the article of food is sent to the United States.

(d) FDA will notify you that your prior notice has been confirmed for review with a reply message that contains a Prior Notice (PN) Confirmation Number. Your prior notice will be considered submitted and the prior notice time will start when FDA has confirmed your prior notice for review.

(e) The PN Confirmation Number must accompany any article of food arriving by international mail. The PN Confirmation Number must appear on the Customs Declaration that accompanies the package.

(f) A copy of the confirmation, including the PN Confirmation Number, must accompany any article of food that is subject to this subpart when it is carried by or otherwise accompanies an individual when arriving in the United States. The copy of the confirmation must be provided to CBP or FDA upon arrival.

(g) The PN Confirmation Number must accompany any article of food for which the prior notice was submitted through the FDA Prior Notice System Interface (FDA PN System Interface) when the article arrives in the United States and must be provided to CBP or FDA upon arrival.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]

(a) You must submit the prior notice electronically to FDA. You must submit all prior notice information in the English language, except that an individual's name, the name of a company, and the name of a street may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet. Unless paragraphs (c) and (d) of this section apply, you must submit prior notice through:

(1) The CBP Automated Broker Interface of the Automated Commercial System (ABI/ACS); or

(2) The FDA PN System Interface at http://www.access.fda.gov. You must submit prior notice through the FDA PN System Interface for articles of food imported or offered for import by international mail, other transaction types that cannot be made through ABI/ACS, and articles of food that have been refused under section 801(m)(1) of the act and this subpart.

(b) If a custom broker's or self-filer's system is not working or if the ABI/ACS interface is not working, prior notice must be submitted through the FDA PN System Interface.

(c) If FDA determines that FDA PN System Interface is not working, FDA will issue notification at http://www.access.fda.gov or http://www.cfsan.fda.gov/˜furls/fisstat.php, whichever FDA determines is available. Once FDA issues this notification, if you intended to use the FDA PN System Interface to submit a prior notice, you must submit prior notice information by e-mail or by fax to FDA. The location for receipt of submission by e-mail or fax will be listed at http://www.access.fda.gov or http://www.cfsan.fda.gov/˜furls/fisstat.php, whichever FDA determines is available.

(d) If FDA determines that the Operational and Administration System for Import Support (OASIS) is not working, FDA will issue notification at http://www.cfsan.fda.gov/˜fulrs/fisstat.php, on the FDA Web site at http://www.fda.gov, and through messages in ABI/ACS. Once FDA issues this notification, all prior notices must be submitted to FDA by e-mail or by fax. The location for receipt of submission by e-mail or fax will be listed at http://www.access.fda.gov or http://www.cfsan.fda.gov/˜furls;fisstat.php, whichever FDA determines is available.

(e) Prior notice information will only be accepted at the listed e-mail or fax locations if FDA determines that the FDA PN System Interface or OASIS is not working.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2003; 69 FR 8330, Feb. 24, 2004]

(a) General. For each article of food that is imported or offered for import into the United States, except by international mail, you must submit the information for the article that is required in this paragraph.

(1) The name of the individual submitting the prior notice and his/her business address, and phone number, fax number, and e-mail address, and the name and address of the submitting firm, if applicable. If a registration number is provided, city and country may be provided instead of the full address;

(2) If different from the submitter, the name of the individual and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her business address, and phone number, fax number, and e-mail address. If a registration number is provided, city and country may be provided instead of the full address;

(3) The entry type;

(4) The CBP entry identifier (e.g., CBP entry number or in-bond number), if available;

(5) The identity of the article of food being imported or offered for import, as follows:

(i) The complete FDA product code;

(ii) The common or usual name or market name;

(iii) The estimated quantity of food that will be shipped, described from largest container to smallest package size; and

(iv) The lot or code numbers or other identifier of the food if required by the act or FDA regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant formula, by 21 CFR 106.90;

(6) For an article of food that is no longer in its natural state, the name and address of the manufacturer and the registration number assigned to the facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If the article of food is sent by an individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States, you may provide the name and address of the firm that appears on the label under 21 CFR 101.5 instead of the name, address, and registration number of the manufacturer. If a registration number is provided, city and country may be provided instead of the full address;

(7) For an article of food that is in its natural state, the name and growing location address of the grower, if known. If the submitter does not know the identity of the grower or, if the article has been consolidated and the submitter does not know the identity of any of the growers, you may provide the name and address of the firm that has consolidated the articles of food from different growers or different growing locations;

(8) The FDA Country of Production;

(9) The name and address of the shipper and, if the shipper is required to register under 21 CFR part 1, subpart H, the registration number assigned to the shipper's facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If a registration number is provided, city and country may be provided instead of the full address;

(10) The country from which the article is shipped;

(11) Anticipated arrival information about the article of food being imported or offered for import, as follows:

(i) The anticipated port of arrival and, if the anticipated port of arrival has more than one border crossing, the specific anticipated border crossing where the food will be brought into the United States;

(ii) The anticipated date on which the article of food will arrive at the anticipated port of arrival; and

(iii) The anticipated time of that arrival;

(12) The name and address of the importer. If a registration number is provided, city and country may be provided instead of the full address. The identity of the importer is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(13) The name and address of the owner if different from the importer or ultimate consignee. If a registration number is provided, city and country may be provided instead of the full address. The identity of the owner is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(14) The name and address of the ultimate consignee. If a registration number is provided, city and country may be provided instead of the full address. The identity of the ultimate consignee is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(15) The mode of transportation;

(16) The Standard Carrier Abbreviation Code (SCAC) or International Air Transportation Association (IATA) code of the carrier which is, or will be, carrying the article of food from the country from which the article is shipped to the United States, or if codes are not applicable, then the name and country of the carrier;

(17) Planned shipment information, as applicable:

(i) The Airway Bill number(s) or Bill of Lading number(s). This information is not required for an article of food when carried by or otherwise accompanying an individual when entering the United States;

(ii) For food arriving by ocean vessel, the vessel name and voyage number;

(iii) For food arriving by air carrier, the flight number;

(iv) For food arriving by truck, bus, or rail, the trip number;

(v) For food arriving as containerized cargo by water, air, or land, the container number(s). This information is not required for an article of food when carried by or otherwise accompanying an individual when entering the United States;

(vi) For food arriving by rail, the car number. This information is not required for an article of food when carried by or otherwise accompanying an individual;

(vii) For food arriving by privately owned vehicle, the license plate number and State or province; and

(viii) The 6-digit Harmonized Tariff Schedule (HTS) code.

(b) Articles arriving by international mail. For each article of food that is imported or offered for import into the United States by international mail, you must submit the information for the article that is required in this paragraph.

(1) The name of the individual submitting the prior notice and his/her business address, and phone number, fax number, and e-mail address, and the name and address of the submitting firm, if applicable. If a registration number is provided, city and country may be provided instead of the full address;

(2) If different from the submitter, the name of the individual and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her business address and phone number, fax number, and e-mail address. If a registration number is provided, city and country may be provided instead of the full address;

(3) The entry type (which will be a mail entry);

(4) The identity of the article of food being imported or offered for import, as follows:

(i) The complete FDA product code;

(ii) The common or usual name or market name;

(iii) The estimated quantity of food that will be shipped, described from largest container to smallest package size; and

(iv) The lot or code numbers or other identifier of the food if required by the act or FDA regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant formula, 21 CFR 106.90;

(5) For an article of food that is no longer in its natural state, the name and address of the manufacturer and the registration number assigned to the facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If the article of food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the United States, you may provide the name and address of the firm that appears on the label under 21 CFR 101.5 instead of the name, address, and registration number of the manufacturer. If a registration number is provided, city and country may be provided instead of the full address;

(6) For an article of food that is in its natural state, the name and growing location address of the grower, if known. If the submitter does not know the identity of the grower or, if the article has been consolidated and the submitter does not know the identity of any of the growers, you may provide the name and address of the firm that has consolidated the articles of food from different growers or different growing locations;

(7) The FDA Country of Production;

(8) The name and address of the shipper and, if the shipper is required to register under 21 CFR part 1, subpart H, the registration number assigned to the shipper's facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If a registration number is provided, city and country may be provided instead of the full address;

(9) The country from which the article is shipped (i.e., mailed);

(10) The anticipated date of mailing; and

(11) The name and address of the U.S. recipient.

(c) Refused articles. If the article of food has been refused under section 801(m)(1) of the act and this subpart, you must submit the information for the article that is required in this paragraph. However, if the refusal is based on §1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to re-submit any information previously submitted unless it has changed or the article has been exported and the original prior notice was submitted through ABI/ACS. If the refusal is based on §1.283(a)(1)(ii), you should cancel the previous submission per §1.282(b) and (c).

(1) The name of the individual submitting the prior notice and his/her business address, and phone number, fax number, and e-mail address, and the name and address of the submitting firm, if applicable. If a registration number is provided, city and country may be provided instead of the full address;

(2) If different from the submitter, the name of the individual and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her business address, and phone number, fax number, and e-mail address. If the registration number is provided, city and country may be provided instead of the full address;

(3) The entry type;

(4) The CBP entry identifier (e.g., CBP entry number or in-bond number), if available;

(5) The identity of the article of food being imported or offered for import, as follows:

(i) The complete FDA product code;

(ii) The common or usual name or market name;

(iii) The quantity of food that was shipped, described from largest container to smallest package size; and

(iv) The lot or code numbers or other identifier of the food if required by the act or FDA regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant formula, by 21 CFR 106.90;

(6) For an article of food that is no longer in its natural state, the name and address of the manufacturer and the registration number assigned to the facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If the article of food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the United States, you may provide the name and address of the firm that appears on the label under 21 CFR 101.5 instead of the name, address, and registration number of the manufacturer. If a registration number is provided, city and country may be provided instead of the full address;

(7) For an article of food that is in its natural state, the name and growing location address of the grower, if known. If the submitter does not know the identity of the grower or, if the article has been consolidated and the submitter does not know any of the growers, you may provide the name and address of the firm that has consolidated the articles of food from different growers or different growing locations;

(8) The FDA Country of Production;

(9) The name and address of the shipper and, if the shipper is required to register under 21 CFR part 1, subpart H, the registration number assigned to the shipper's facility that is associated with the article of food. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export, or further manipulation and export. If a registration number is provided, city and country may be provided instead of the full address;

(10) The country from which the article is shipped;

(11) The port of arrival;

(12) The name and address of the importer. If a registration number is provided, city and country may be provided instead of the full address. The identity of the importer is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(13) The name and address of the owner, if different from the importer or ultimate consignee. If a registration number is provided, city and country may be provided instead of the full address. The identity of the importer is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(14) The name and address of the ultimate consignee. If a registration number is provided, city and country may be provided instead of the full address. The identity of the ultimate consignee is not required for an article of food that is imported or offered for import for transshipment through the United States under a Transportation and Exportation entry;

(15) The mode of transportation;

(16) The Standard Carrier Abbreviation Code (SCAC) or International Air Transportation Association (IATA) code of the carrier which carried the article of food from the country from which the article is shipped to the United States, or if codes are not applicable, then the name and country of the carrier;

(17) Shipment information, as applicable:

(i) The Airway Bill number(s) or Bill of Lading number(s); however, this information is not required for an article of food when carried by or otherwise accompanying an individual when entering the United States;

(ii) For food that arrived by ocean vessel, the vessel name and voyage number;

(iii) For food that arrived by air carrier, the flight number;

(iv) For food that arrived by truck, bus, or rail, the trip number;

(v) For food that arrived as containerized cargo by water, air, or land, the container number(s); however, this information is not required for an article of food when carried by or otherwise accompanying an individual when entering the United States;

(vi) For food that arrived by rail, the car number; however, this information is not required for an article of food when carried by or otherwise accompanying an individual;

(vii) For food that arrived by privately owned vehicle, the license plate number and State or province;

(viii) The 6-digit HTS code; and

(18) The location and address where the article of refused food will be or is being held, the date the article has arrived or will arrive at that location, and identification of a contact at that location.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]

(a)(1) If any of the information required in §1.281(a) except the information required in:

(i) §1.281(a)(5)(iii) (quantity),

(ii) §1.281(a)(11) (anticipated arrival information), or

(iii) §1.281(a)(17) (planned shipment information) changes after you receive notice that FDA has confirmed your prior notice submission for review, you must resubmit prior notice in accordance with this subpart unless the article of food will not be offered for import or imported into the United States.

(2) If any of the information required in §1.281(b), except the information required in §1.281(b)(10) (the anticipated date of mailing), changes after you receive notice that FDA has confirmed your prior notice submission for review, you must resubmit prior notice in accordance with this subpart, unless the article of food will not be offered for import or imported into the United States.

(b) If you submitted the prior notice via the FDA PN System Interface, you should cancel the prior notice via the FDA PN System Interface.

(c) If you submitted the prior notice via ABI/ACS, you should cancel the prior notice via ACS by requesting that CBP delete the entry.

(a) For each article of food that is imported or offered for import into the United States, except for food arriving by international mail or food carried by or otherwise accompanying an individual, the consequences are:

(1) Inadequate prior notice—(i) No prior notice. If an article of food arrives at the port of arrival and no prior notice has been submitted and confirmed by FDA for review, the food is subject to refusal of admission under section 801(m)(1) of the act (21 U.S.C. 381(m)(1)). If an article of food is refused for lack of prior notice, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.

(ii) Inaccurate prior notice. If prior notice has been submitted and confirmed by FDA for review, but upon review of the notice or examination of the article of food, the notice is determined to be inaccurate, the food is subject to refusal of admission under section 801(m)(1) of the act (21 U.S.C. 381(m)(1)). If the article of food is refused due to inaccurate prior notice, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.

(iii) Untimely prior notice. If prior notice has been submitted and confirmed by FDA for review, but the full time that applies under §1.279 of this subpart for prior notice has not elapsed when the article of food arrives, the food is subject to refusal of admission under section 801(m)(1) of the act (21 U.S.C. 381(m)(1)), unless FDA has already reviewed the prior notice, determined its response to the prior notice, and advised CBP of that response. If the article of food is refused due to untimely prior notice, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.

(2) Status and movement of refused food. (i) An article of food that has been refused under section 801(m)(1) of the act and paragraph (a) of this section shall be considered general order merchandise as described in section 490 of the Tariff Act of 1930, as amended, 19 U.S.C. 1490.

(ii) Refused food must be moved under appropriate custodial bond. FDA must be notified of the location where the food has been or will be moved, within 24 hours of refusal. The refused food shall not be entered and shall not be delivered to any importer, owner, or ultimate consignee. The food must be taken directly to the designated location.

(3) Segregation of refused foods. If an article of food that is refused is part of a shipment that contains articles of food that have not been placed under hold, the refused article of food may be segregated from the rest of the shipment. This segregation must take place where the article is held. FDA or CBP may supervise segregation. If FDA or CBP determines that supervision is necessary, segregation must not take place without supervision.

(4) Costs. Neither FDA nor CBP are liable for transportation, storage, or other expenses resulting from refusal.

(5) Export after refusal. An article of food that has been refused under §1.283(a) may be exported with CBP concurrence and under CBP supervision unless it is seized or administratively detained by FDA or CBP under other authority. If an article of food that has been refused admission under §1.283(a) is exported, the prior notice should be cancelled within 5 business days of exportation.

(6) No post-refusal submission or request for review. If an article of food is refused under section 801(m)(1) and no prior notice is submitted or resubmitted, no request for FDA review is submitted in a timely fashion, or export has not occurred in accordance with paragraph (a)(5) of this section, the article of food shall be dealt with as set forth in CBP regulations relating to general order merchandise (19 CFR part 127), except that the article may only be sold for export or destroyed as agreed to by CBP and FDA.

(b) Food carried by or otherwise accompanying an individual. If food carried by or otherwise accompanying an individual arriving in the United States is not for personal use and does not have adequate prior notice or the individual cannot provide FDA or CBP with a copy of the PN confirmation, the food is subject to refusal of admission under section 801(m)(1) of the act. If before leaving the port, the individual does not arrange to have the food held at the port or exported, the article of food may be destroyed.

(c) Post-Refusal Prior Notice Submissions. (1) If an article of food is refused under §1.283(a)(1)(i) (no prior notice) and the food is not exported, prior notice must be submitted in accordance with §§1.280 and 1.281(c) of this subpart.

(2) If an article of food is refused under §1.283(a)(1)(ii) (inaccurate prior notice) and the food is not exported, you should cancel the prior notice in accordance with §1.282 and must resubmit prior notice in accordance with §§1.280 and 1.281(c).

(3) Once the prior notice has been submitted or resubmitted and confirmed by FDA for review, FDA will endeavor to review and respond to the prior notice submission within the timeframes set out in §1.279.

(d) FDA Review After Refusal. (1) If an article of food has been refused admission under section 801(m)(1) of the act, a request may be submitted asking FDA to review whether the article is subject to the requirements of this subpart under §1.276(b)(5) or §1.277, or whether the information submitted in a prior notice is accurate. A request for review may not be used to submit prior notice or to resubmit an inaccurate prior notice.

(2) A request may be submitted only by the submitter, importer, owner, or ultimate consignee. A request must identify which one the requester is.

(3) A request must be submitted in writing to FDA and delivered by mail, express courier, fax, or e-mail. The location for receipt of a request is listed at http://www.fda.gov—see Prior Notice. A request must include all factual and legal information necessary for FDA to conduct its review. Only one request for review may be submitted for each refused article.

(4) The request must be submitted within 5 calendar days of the refusal. FDA will review and respond within 5 calendar days of receiving the request.

(5) If FDA determines that the article is not subject to the requirements of this subpart under §1.276(b)(5) or §1.277 or that the prior notice submission is accurate, it will notify the requester, the transmitter, and CBP that the food is no longer subject to refusal under section 801(m)(1) of the act.

(e) International Mail. If an article of food arrives by international mail with inadequate prior notice or the PN confirmation number is not affixed as required, the parcel will be held by CBP for 72 hours for FDA inspection and disposition. If FDA refuses the article under section 801(m)(1) of the act and there is a return address, the parcel may be returned to sender stamped “No Prior Notice—FDA Refused.” If the article is refused and there is no return address or FDA determines that the article of food in the parcel appears to present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA does not respond within 72 hours of the CBP hold, CBP may return the parcel to the sender or, if there is no return address, destroy the parcel, at FDA expense.

(f) Prohibitions on delivery and transfer. (1) Notwithstanding section 801(b) of the act, an article of food refused under section 801(m)(1) of the act may not be delivered to the importer, owner, or ultimate consignee until prior notice is submitted to FDA in accordance with this subpart, FDA has examined the prior notice, FDA has determined that the prior notice is adequate, and FDA has notified CBP and the transmitter that the article of food is no longer refused admission under section 801(m)(1).

(2) During the time an article of food that has been refused under section 801(m)(1) of the act is held, the article may not be transferred by any person from the port or the secure facility until prior notice is submitted to FDA in accordance with this subpart, FDA has examined the prior notice, FDA has determined that the prior notice is adequate, and FDA has notified CBP and the transmitter that the article of food no longer is refused admission under section 801(m)(1). After this notification by FDA to CBP and transmitter, entry may be made in accordance with law and regulation.

(g) Relationship to other admissibility decisions. A determination that an article of food is no longer refused under section 801(m)(1) of the act is different than, and may come before, determinations of admissibility under other provisions of the act or other U.S. laws. A determination that an article of food is no longer refused under section 801(m)(1) does not mean that it will be granted admission under other provisions of the act or other U.S. laws.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, 4852, Feb. 2, 2004]

(a) The importing or offering for import into the United States of an article of food in violation of the requirements of section 801(m), including the requirements of this subpart, is a prohibited act under section 301(ee) of the act (21 U.S.C. 331(ee)).

(b) Section 301 of the act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done.

(1) Under section 302 of the act (21 U.S.C. 332), the United States can bring a civil action in Federal court to enjoin persons who commit a prohibited act.

(2) Under section 303 of the act (21 U.S.C. 333), the United States can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.

(c) Under section 306 of the 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 or any person who has engaged in a pattern of importing or offering adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.

[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]

(a) If an article of food from a foreign manufacturer that is not registered as required under section 415 of the act (21 U.S.C. 350d) and subpart H is imported or offered for import into the United States, the food is subject to refusal of admission under section 801(m)(1) of the act and §1.283 for failure to provide adequate prior notice. The failure to provide the correct registration number of the foreign manufacturer, if registration is required under section 415 of the act and 21 CFR part 1, subpart H, renders the identity of that facility incomplete for purposes of prior notice.

(b) Unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival, if an article of food is imported or offered for import from a foreign facility that is not registered as required under section 415 of the act and is placed under hold under section 801(l) of the act, it must be held within the port of entry for the article unless directed by CBP or FDA.

(c) Status and movement of held food. (1) An article of food that has been placed under hold under section 801(l) of the act shall be considered general order merchandise as described in section 490 of the Tariff Act of 1930, as amended (19 U.S.C. 1490).

(2) Food under hold under section 801(l) must be moved under appropriate custodial bond. FDA must be notified of the location where the food has been or will be moved, within 24 hours of the hold. The food subject to hold shall not be entered and shall not be delivered to any importer, owner, or ultimate consignee. The food must be taken directly to the designated facility.

(d) Segregation of held foods. If an article of food that has been placed under hold under section 801(l) of the act is part of a shipment that contains articles that have not been placed under hold, the food under hold may be segregated from the rest of the shipment. This segregation must take place where the article is held, if different. FDA or CBP may supervise segregation. If FDA or CBP determine that supervision is necessary, segregation must not take place without supervision.

(e) Costs. Neither FDA nor CBP will be liable for transportation, storage, or other expenses resulting from any hold.

(f) Export after hold. An article of food that has been placed under hold under section 801(l) of the act may be exported with CBP concurrence and under CBP supervision unless it is seized or administratively detained by FDA or CBP under other authority.

(g) No Registration or Request for Review. If an article of food is placed under hold under section 801(l) of the act and no registration or request for FDA review is submitted in a timely fashion or export has not occurred in accordance with subsection (f), the food shall be dealt with as set forth in CBP regulations relating to general order merchandise, except that the article may only be sold for export or destroyed as agreed to by CBP and FDA.

(h) Food carried by or otherwise accompanying an individual. If an article of food carried by or otherwise accompanying an individual arriving in the United States is placed under hold under section 801(l) of the act because it is from a foreign facility that is not registered as required under section 415 of the act, 21 U.S.C. 350d, and subpart H, the individual may arrange to have the food held at the port or exported. If such arrangements cannot be made, the article of food may be destroyed.

(i) Post-refusal and post-hold submissions. (1) Post-refusal. To resolve the refusal if an article of food is refused under §1.283(a) because the facility is not registered, the facility must be registered and after a registration number has been obtained, you should cancel the prior notice and must resubmit the prior notice in accordance with §1.283(c).

(2) Post-hold. To resolve a hold, if an article of food is held under §1.285(b) because it is from a foreign facility that is not registered, the facility must be registered and a registration number must be obtained.

(i) FDA must be notified of the applicable registration number in writing. The notification must provide the name and contact information for the person submitting the information. The notification may be delivered to FDA by mail, express courier, fax, or e-mail. The location for receipt of a notification of registration number associated with an article of food under hold is listed at http://www.fda.gov—see Food Facility Registration. The notification should include the applicable CBP identifier.

(ii) If FDA determines that the article is no longer subject to hold, it will notify the person who provided the registration information and CBP that the food is no longer subject to hold under section 801(l) of the act.

(j) FDA review after hold. (1) If an article of food has been placed under hold under section 801(l) of the act, a request may be submitted asking FDA to review whether the facility associated with the article is subject to the requirements of section 415 of the act. A request for review may not be submitted to obtain a registration number.

(2) A request may be submitted only by the prior notice submitter, importer, owner, or ultimate consignee of the article. A request must identify which one the requestor is.

(3) A request must be submitted in writing to FDA and delivered by mail, express courier, fax or e-mail. The location for receipt of a request is listed at http://www.fda.gov—see Food Facility Registration. A request must include all factual and legal information necessary for FDA to conduct its review. Only one request for review may be submitted for each article under hold.

(4) The request must be submitted within 5 calendar days of the hold. FDA will review and respond within 5 calendar days of receiving the request.

(5) If FDA determines that the article is not from a facility subject to the requirements of section 415, it will notify the requestor and CBP that the food is no longer subject to hold under section 801(l) of the act.

(k) International mail. If an article of food is that arrives by international mail is from a foreign facility that is not registered as required under section 415 of the act (21 U.S.C. 350d) and subpart H, the parcel will be held by CBP for 72 hours for FDA inspection and disposition. If the article is held under section 801(1) of the act and there is a return address, the parcel may be returned to sender stamped “No Registration—No Admission Permitted.” If the article is under hold and there is no return address or FDA determines that the article of food is in the parcel appears to present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA does not respond within 72 hours of the CBP hold, CBP may return the parcel to the sender stamped “No Registration—No Admission Permitted” or, if there is no return address, destroy the parcel, at FDA expense.

(l) Prohibitions on delivery and transfer. (1) Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), an article of food that has been placed under hold section 801(l) of the act may not be delivered to the importer, owner, or ultimate consignee until prior notice is submitted to FDA in accordance with this subpart, FDA has examined the prior notice, FDA has determined that the prior notice is adequate, and FDA has notified CBP and the transmitter that the article of food is no longer subject to hold under section 801(l) of the act.

(2) During the time an article of food that has been refused under section 801(m)(1) of the act is held, the article may not be transferred by any person from the port or the secure facility location until prior notice is submitted to FDA in accordance with this subpart, FDA has examined the prior notice, FDA has determined that the prior notice is adequate, and FDA has notified CBP and the transmitter that the article of food is no longer refused admission under section 801(m)(1) of the act. After this notification by FDA to CBP and transmitter, entry may be made in accordance with law and regulation.

(m) Relationship to other admissibility provisions. A determination that an article of food is no longer subject to hold under section 801(l) of the act is different than, and may come before, determinations of admissibility under other provisions of the act or other U.S. laws. A determination that an article of food is no longer under hold under section 801(l) does not mean that it will be granted admission under other provisions of the act or other U.S. laws.

[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]

Source:  69 FR 71651, Dec. 9, 2004, unless otherwise noted.

General Provisions

(a) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to the regulations in this subpart, unless you qualify for one of the exclusions in §1.327. If you conduct more than one type of activity at a location, you are required to keep records with respect to those activities covered by this subpart, but are not required by this subpart to keep records with respect to activities that fall within one of the exclusions in §1.327.

(b) Persons subject to the regulations in this subpart must keep records whether or not the food is being offered for or enters interstate commerce.

(a) Farms are excluded from all of the requirements in this subpart.

(b) Restaurants are excluded from all of the requirements in this subpart. A restaurant/retail facility is excluded from all of the requirements in this subpart if its sales of food it prepares and sells to consumers for immediate consumption are more than 90 percent of its total food sales.

(c) 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, are excluded from all of the requirements in this subpart, except §§1.361 and 1.363. However, those fishing vessels otherwise engaged in processing fish are subject to all of the requirements in 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.

(d) Persons who distribute food directly to consumers are excluded from the requirements in §1.345 to establish and maintain records to identify the nontransporter and transporter immediate subsequent recipients as to those transactions. The term “consumers” does not include businesses.

(e) Persons who operate retail food establishments that distribute food to persons who are not consumers are subject to all of the requirements in this subpart. However, the requirements in §1.345 to establish and maintain records to identify the nontransporter and transporter immediate subsequent recipients that are not consumers applies as to those transactions only to the extent the information is reasonably available.

(1) For purposes of this section, retail food establishment is defined to mean an establishment that sells food products directly to consumers as its primary function. The term “consumers” does not include businesses.

(2) A retail food establishment may 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.

(3) 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.

(4) A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.

(f) Retail food establishments that employ 10 or fewer full-time equivalent employees are excluded from all of the requirements in this subpart, except §§1.361 and 1.363. The exclusion is based on the number of full-time equivalent employees at each retail food establishment and not the entire business, which may own numerous retail stores.

(g) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) 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.) are excluded from all of the requirements in this subpart with respect to that food while it is under the exclusive jurisdiction of USDA.

(h) Foreign persons, except for foreign persons who transport food in the United States, are excluded from all of the requirements of this subpart.

(i) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food are subject to §§1.361 and 1.363 with respect to its packaging (the outer packaging of food that bears the label and does not contact the food). All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import packaging are excluded from all of the requirements of this subpart.

(j) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact substances other than the finished container that directly contacts food are excluded from all of the requirements of this subpart, except §§1.361 and 1.363.

(k) Persons who place food directly in contact with its finished container are subject to all of the requirements of this subpart as to the finished container that directly contacts that food. All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import the finished container that directly contacts the food are excluded from the requirements of this subpart as to the finished container, except §§1.361 and 1.363.

(l) Nonprofit food establishments are excluded from all of the requirements in this subpart, except §§1.361 and 1.363.

(m) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food for personal consumption are excluded from all of the requirements of this subpart.

(n) Persons who receive or hold food on behalf of specific individual consumers and who are not also parties to the transaction and who are not in the business of distributing food are excluded from all of the requirements of this subpart.

The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when used in this subpart. In addition, for the purposes of this subpart:

Act means the Federal Food, Drug, and Cosmetic Act.

Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling produce are considered part of harvesting. The term “farm” includes:

(1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and

(2) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

Food has the meaning given in section 201(f) of the act. Examples of food include, but are not limited to 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 and additives, including substances that migrate into food from the finished container and other articles that contact food; 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.

Full-time equivalent employee means all individuals employed by the person claiming the exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks).

Holding means storage of food. Holding facilities 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 are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.

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)).

Nontransporter means a person who owns food or who holds, manufactures, processes, packs, imports, receives, or distributes food for purposes other than transportation.

Nontransporter immediate previous source means a person that last had food before transferring it to another nontransporter.

Nontransporter immediate subsequent recipient means a nontransporter that acquires food from another nontransporter.

Packaging means the outer packaging of food that bears the label and does not contact the food. Packaging does not include food contact substances as they are defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)).

Person includes individual, partnership, corporation, and association.

Recipe means the formula, including ingredients, quantities, and instructions, necessary to manufacture a food product. Because a recipe must have all three elements, a list of the ingredients used to manufacture a product without quantity information and manufacturing instructions is not a recipe.

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) Facilities in which food is directly 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.

(2) Pet shelters, kennels, and veterinary facilities in which food is directly provided to animals are restaurants.

Transporter means a person who has possession, custody, or control of an article of food in the United States for the sole purpose of transporting the food, whether by road, rail, water, or air. Transporter also includes a foreign person that transports food in the United States, regardless of whether that foreign person has possession, custody, or control of that food for the sole purpose of transporting that food.

Transporter's immediate previous source means a person from whom a transporter received food. This source can be either another transporter or a nontransporter.

Transporter's immediate subsequent recipient means a person to whom a transporter delivered food. This recipient can be either another transporter or a nontransporter.

You means a person subject to this subpart under §1.326.

(a) In addition to the regulations in this subpart, you must comply with all other applicable statutory provisions and regulations related to the establishment and maintenance of records for foods except as described in paragraph (b) of this section. For example, the regulations in this subpart are in addition to existing recordkeeping regulations for low acid canned foods, juice, seafood, infant formula, color additives, bottled water, animal feed, and medicated animal feed.

(b) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in §11.3(b)(6) (21 CFR 11.3 (b)(6)) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.

The regulations in this subpart do not require duplication of existing records if those records contain all of the information required by this subpart. If a covered person keeps records of all of the information as required by this subpart to comply with other Federal, State, or local regulations, or for any other reason, then those records may be used to meet these requirements. Moreover, persons do not have to keep all of the information required by this rule in one set of records. If they have records containing some of the required information, they may keep those existing records and keep, either separately or in a combined form, any new information required by this rule. There is no obligation to create an entirely new record or compilation of records containing both existing and new information, even if the records containing some of the required information were not created at the time the food was received or released.

(a) If you are a nontransporter, you must establish and maintain the following records for all food you receive:

(1) The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the nontransporter immediate previous source, whether domestic or foreign;

(2) An adequate description of the type of food received, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

(3) The date you received the food;

(4) For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists);

(5) The quantity and how the food is packaged (e.g., 6 count bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) tank); and

(6) The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate previous source (the transporter who transported the food to you).

(a) If you are a nontransporter, you must establish and maintain the following records for food you release:

(1) The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the nontransporter immediate subsequent recipient, whether domestic or foreign;

(2) An adequate description of the type of food released, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

(3) The date you released the food;

(4) For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists);

(5) The quantity and how the food is packaged (e.g., 6 count bunches, 25 lb carton, 12 oz bottle, 100 gal tank);

(6) The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate subsequent recipient (the transporter who transported the food from you); and

(b) Your records must include information reasonably available to you to identify the specific source of each ingredient used to make every lot of finished product.

If you are a transporter, you must establish and maintain the following records for each food you transport in the United States. You may fulfill this requirement by either:

(a) Establishing and maintaining the following records:

(1) Names of the transporter's immediate previous source and transporter's immediate subsequent recipient;

(2) Origin and destination points;

(3) Date shipment received and date released;

(4) Number of packages;

(5) Description of freight;

(6) Route of movement during the time you transported the food; and

(7) Transfer point(s) through which shipment moved; or

(b) Establishing and maintaining records containing the following information currently required by the Department of Transportation's Federal Motor Carrier Safety Administration (of roadway interstate transporters (49 CFR 373.101 and 373.103) as of December 9, 2004:

(1) Names of consignor and consignee;

(2) Origin and destination points;

(3) Date of shipment;

(4) Number of packages;

(5) Description of freight;

(6) Route of movement and name of each carrier participating in the transportation; and

(7) Transfer points through which shipment moved; or

(c) Establishing and maintaining records containing the following information currently required by the Department of Transportation's Surface Transportation Board of rail and water interstate transporters (49 CFR 1035.1 and 1035.2) as of December 9, 2004:

(1) Date received;

(2) Received from;

(3) Consigned to;

(4) Destination;

(5) State of;

(6) County of;

(7) Route;

(8) Delivering carrier;

(9) Car initial;

(10) Car no;

(11) Trailer initials/number;

(12) Container initials/number;

(13) No. packages; and

(14) Description of articles; or

(d) Establishing and maintaining records containing the following information currently required by the Warsaw Convention of international air transporters on air waybills:

(1) Shipper's name and address;

(2) Consignee's name and address;

(3) Customs reference/status;

(4) Airport of departure and destination;

(5) First carrier; and

(6) Description of goods; or

(e) Entering into an agreement with the nontransporter immediate previous source located in the United States and/or the nontransporter immediate subsequent recipient located in the United States to establish, maintain, or establish and maintain, the information in §1.352(a), (b), (c), or (d). The agreement must contain the following elements:

(1) Effective date;

(2) Printed names and signatures of authorized officials;

(3) Description of the records to be established and/or maintained;

(4) Provision for the records to be maintained in compliance with §1.360, if the agreement provides for maintenance of records;

(5) Provision for the records to be available to FDA as required by §1.361, if the agreement provides for maintenance of records;

(6) Acknowledgement that the nontransporter assumes legal responsibility under §1.363 for establishing and/or maintaining the records as required by this subpart; and

(7) Provision that if the agreement is terminated in writing by either party, responsibility for compliance with the applicable establishment, maintenance, and access provisions of this subpart reverts to the transporter as of the date of termination.

(a) You must create the required records when you receive and release food, except to the extent that the information is contained in existing records.

(b) If you are a nontransporter, you must retain for 6 months after the dates you receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date you receive or release the food.

(c) If you are a nontransporter, you must retain for 1 year after the dates you receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days, but within 6 months, after the date you receive or release the food.

(d) If you are a nontransporter, you must retain for 2 years after the dates you receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability does not occur sooner than 6 months after the date you receive or release the food, including foods preserved by freezing, dehydrating, or being placed in a hermetically sealed container.

(e) If you are a nontransporter, you must retain for 1 year after the dates you receive and release the food all required records for animal food, including pet food.

(f) If you are a transporter or nontransporter retaining records on behalf of a transporter, you must retain for 6 months after the dates you receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date the transporter receives or releases the food. If you are a transporter, or nontransporter retaining records on behalf of a transporter, you must retain for 1 year after the dates you receive and release the food, all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days after the date the transporter receives or releases the food.

(g) You must retain all records at the establishment where the covered activities described in the records occurred (onsite) or at a reasonably accessible location.

(h) The maintenance of electronic records is acceptable. Electronic records are considered to be onsite if they are accessible from an onsite location.

When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.

The establishment and maintenance of records as required by this subpart does not extend to recipes for food as defined in §1.328; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).

(a) The failure to establish or maintain records as required by section 414(b) of the act and this regulation or the refusal to permit access to or verification or copying of any such required record is a prohibited act under section 301 of the act.

(b) The failure of a nontransporter immediate previous source or a nontransporter immediate subsequent recipient who enters an agreement under §1.352(e) to establish, maintain, or establish and maintain, records required under §1.352(a), (b), (c), or (d), or the refusal to permit access to or verification or copying of any such required record, is a prohibited act under section 301 of the act.

(c) The failure of any person to make records or other information available to FDA as required by section 414 or 704(a) of the act and this regulation is a prohibited act under section 301 of the act.

[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8726, Feb. 23, 2005]

The compliance date for the requirements in this subpart is December 9, 2005. However, the compliance dates for small and very small businesses are contained in paragraphs (a) and (b) of this section. The size of the business is determined using the total number of full-time equivalent employees in the entire business, not each individual location or establishment. A full-time employee counts as one full-time equivalent employee. Two part-time employees, each working half time, count as one full-time equivalent employee.

(a) The compliance date for the requirements in this subpart is June 9, 2006, for small businesses employing fewer that 500, but more than 10 full-time equivalent employees.

(b) The compliance date for the requirements in this subpart is December 11, 2006, for very small businesses that employ 10 or fewer full-time equivalent employees.

[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8727, Feb. 23, 2005]

Source:  69 FR 31701, June 4, 2004, unless otherwise noted.

General Provisions

The definitions of terms that appear in section 201 of the act (21 U.S.C. 321) apply when the terms are used in this subpart. In addition, for the purposes of this subpart:

Act means the Federal Food, Drug, and Cosmetic Act.

Authorized FDA representative means an FDA District Director in whose district the article of food involved is located or an FDA official senior to such director.

Calendar day means every day shown on the calendar.

Food has the meaning given in section 201(f) of the act (21 U.S.C. 321(f)). Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, 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.

Perishable food means food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 calendar days under normal shipping and storage conditions.

We means the U.S. Food and Drug Administration (FDA).

Working day means any day from Monday through Friday, excluding Federal holidays.

You means any person who received the detention order or that person's representative.

An officer or qualified employee of FDA may order the detention of any article of food that is found during an inspection, examination, or investigation under the act if the officer or qualified employee has credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.

(a) FDA may detain an article of food for a reasonable period that may not exceed 20 calendar days after the detention order is issued. However, an article may be detained for 10 additional calendar days if a greater period of time is required to institute a seizure or injunction action. The authorized FDA representative may approve the additional 10-calendar day detention period at the time the detention order is issued, or at any time within the 20-calendar day period by amending the detention order.

(b) The entire detention period may not exceed 30 calendar days.

(c) An authorized FDA representative may, in accordance with §1.384, terminate a detention order before the expiration of the detention period.

(a) You must hold the detained article of food in the location and under the conditions specified by FDA in the detention order.

(b) If FDA determines that removal to a secure facility is appropriate, the article of food must be removed to a secure facility. A detained article of food remains under detention before, during, and after movement to a secure facility. FDA will also state in the detention order any conditions of transportation applicable to the detained article.

(c) If FDA directs you to move the detained article of food to a secure facility, you must receive a modification of the detention order under §1.381(c) before you move the detained article of food to a secure facility.

(d) You must ensure that any required tags or labels under §1.382 accompany the detained article during and after movement. The tags or labels must remain with the article of food until FDA terminates the detention order or the detention period expires, whichever occurs first, unless otherwise permitted by the authorized FDA representative.

(e) The movement of an article of food in violation of a detention order issued under §1.393 is a prohibited act under section 301 of the act (21 U.S.C. 331).

(a) An article of food subject to a detention order under this subpart may not be delivered under the execution of a bond. Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), while any article of food is subject to a detention order under section 304(h) of the act (21 U.S.C. 334(h)), it may not be delivered to any of its importers, owners, or consignees. This section does not preclude movement at FDA's direction of imported food to a secure facility under an appropriate Customs' bond when that bond is required by Customs' law and regulation.

(b) Except as provided in paragraph (c) of this section, no person may transfer a detained article of food within or from the place where it has been ordered detained, or from the place to which it was removed, until an authorized FDA representative releases the article of food under §1.384 or the detention period expires under §1.379, whichever occurs first.

(c) The authorized FDA representative may approve, in writing, a request to modify a detention order to permit movement of a detained article of food for any of the following purposes:

(1) To destroy the article of food,

(2) To move the detained article of food to a secure facility under the terms of a detention order,

(3) To maintain or preserve the integrity or quality of the article of food, or

(4) For any other purpose that the authorized FDA representative believes is appropriate in the case.

(d) You must submit your request for modification of the detention order in writing to the authorized FDA representative who approved the detention order. You must state in your request the reasons for movement; the exact address of and location in the new facility (or the new location within the same facility) where the detained article of food will be transferred; an explanation of how the new address and location will be secure, if FDA has directed that the article be detained in a secure facility; and how the article will be held under any applicable conditions described in the detention order. If you are requesting modification of a detention order for the purpose of destroying the detained article of food, you also must submit a verified statement identifying the ownership or proprietary interest you have in the detained article of food, in accordance with Supplemental Rule C to the “Federal Rules of Civil Procedure.”

(e) If FDA approves a request for modification of a detention order, the article may be transferred but remains under detention before, during, and after the transfer. FDA will state any conditions of transportation applicable to the detained article. You may not transfer a detained article of food without FDA supervision unless FDA has declined in writing to supervise the transfer. If FDA has declined in writing to supervise the transfer of a detained article, you must immediately notify in writing the authorized FDA representative who approved the modification of the detention order that the article of food has reached its new location, and the specific location of the detained article within the new location. Such written notification may be in the form of a fax, e-mail, or other form as agreed to by the authorized FDA representative.

(f) You must ensure that any required tags or labels under §1.382 accompany the detained article during and after movement. The tags or labels must remain with the article of food until FDA terminates the detention order or the detention period expires, whichever occurs first, unless otherwise permitted by the authorized FDA representative who approves the modification of a detention order under this section.

(g) The transfer of an article of food in violation of a detention order issued under §1.393 is a prohibited act under section 301 of the act.

The officer or qualified employee of FDA issuing a detention order under §1.393 may label or mark the detained article of food with official FDA tags or labels that include the following information:

(a) A statement that the article of food is detained by FDA in accordance with section 304(h) of the act;

(b) A statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative;

(c) A statement that the violation of a detention order or the removal or alteration of the tag or label is a prohibited act, punishable by fine or imprisonment or both; and

(d) The detention order number, the date and hour of the detention order, the detention period, and the name of the officer or qualified employee of FDA who issued the detention order.

If FDA initiates a seizure action under section 304(a) of the act against a perishable food subject to a detention order under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4 calendar days after the detention order is issued, unless extenuating circumstances exist. If the fourth calendar day is not a working day, FDA will advise the DOJ of its plans to recommend a seizure action on the last working day before the fourth calendar day and send the recommendation as soon as practicable on the first working day that follows. For purposes of this section, an extenuating circumstance includes, but is not limited to, instances when the results of confirmatory testing or other evidentiary development requires more than 4 calendar days to complete.

If FDA terminates a detention order or the detention period expires, an authorized FDA representative will issue a detention termination notice releasing the article of food to any person who received the detention order or that person's representative and will remove, or authorize in writing the removal of, the required labels or tags. If FDA fails to issue a detention termination notice and the detention period expires, the detention is deemed to be terminated.

An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official senior to such director, must approve a detention order. If prior written approval is not feasible, prior oral approval must be obtained and confirmed in writing as soon as possible.

(a) FDA must issue the detention order to the owner, operator, or agent in charge of the place where the article of food is located. If the owner of the article of food is different from the owner, operator, or agent in charge of the place where the article is detained, FDA must provide a copy of the detention order to the owner of the article of food if the owner's identity can be determined readily.

(b) If FDA issues a detention order for an article of food located in a vehicle or other carrier used to transport the detained article of food, FDA also must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier, if their identities can be determined readily.

(a) FDA must issue the detention order in writing, in the form of a detention notice, signed and dated by the officer or qualified employee of FDA who has credible evidence or information indicating that such article of food presents a threat of serious adverse health consequences or death to humans or animals.

(b) The detention order must include the following information:

(1) The detention order number;

(2) The date and hour of the detention order;

(3) Identification of the detained article of food;

(4) The period of the detention;

(5) A statement that the article of food identified in the order is detained for the period shown;

(6) A brief, general statement of the reasons for the detention;

(7) The address and location where the article of food is to be detained and the appropriate storage conditions;

(8) Any applicable conditions of transportation of the detained article of food;

(9) A statement that the article of food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless the detention order is first modified under §1.381(c);

(10) The text of section 304(h) of the act and §§1.401 and 1.402;

(11) A statement that any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in §1.403;

(12) The mailing address, telephone number, e-mail address, and fax number of the FDA district office and the name of the FDA District Director in whose district the detained article of food is located;

(13) A statement indicating the manner in which approval of the detention order was obtained, i.e., verbally or in writing; and

(14) The name and the title of the authorized FDA representative who approved the detention order.

Any person who would be entitled to be a claimant for the article of food, if seized under section 304(a) of the act, may appeal a detention order as specified in §1.402. Procedures for establishing entitlement to be a claimant for purposes of section 304(a) of the act are governed by Supplemental Rule C to the “Federal Rules of Civil Procedure.”

(a) If you want to appeal a detention order, you must submit your appeal in writing to the FDA District Director, in whose district the detained article of food is located, at the mailing address, e-mail address, or fax number identified in the detention order according to the following applicable timeframes:

(1) Perishable food: If the detained article is a perishable food, as defined in §1.377, you must file an appeal within 2 calendar days of receipt of the detention order.

(2) Nonperishable food: If the detained article is not a perishable food, as defined in §1.377, you must file a notice of an intent to request a hearing within 4 calendar days of receipt of the detention order. If the notice of intent is not filed within 4 calendar days, you will not be granted a hearing. If you have not filed a timely notice of intent to request a hearing, you may file an appeal without a hearing request. Whether or not it includes a request for hearing, your appeal must be filed within 10 calendar days of receipt of the detention order.

(b) Your request for appeal must include a verified statement identifying your ownership or proprietary interest in the detained article of food, in accordance with Supplemental Rule C to the “Federal Rules of Civil Procedure.”

(c) The process for the appeal of a detention order under this section terminates if FDA institutes either a seizure action under section 304(a) of the act or an injunction under section 302 of the act (21 U.S.C. 276) regarding the article of food involved in the detention order.

(d) As part of the appeals process, you may request an informal hearing. Your request for a hearing must be in writing and must be included in your request for an appeal specified in paragraph (a) of this section. If you request an informal hearing, and FDA grants your request, the hearing will be held within 2 calendar days after the date the appeal is filed.

If FDA grants a request for an informal hearing on an appeal of a detention order, FDA must conduct the hearing in accordance with part 16 of this chapter, except that:

(a) The detention order under §1.393, rather than the notice under §16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under §16.80(a) of this chapter;

(b) A request for a hearing under this section must be addressed to the FDA District Director in whose district the article of food involved is located;

(c) The provision in §16.22(b) of this chapter, providing that a person not be given less than 3 working days after receipt of notice to request a hearing, does not apply to a hearing under this subpart;

(d) The provision in §16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this subpart;

(e) Section 1.406, rather than §16.24(f) of this chapter, describes the statement that will be provided to an appellant where a detention order is based on classified information;

(f) Section 1.404, rather than §16.42(a) of this chapter, describes the FDA employees, e.g., Regional Food and Drug Directors or other officials senior to a District Director, who preside at hearings under this subpart;

(g) The presiding officer may require that a hearing conducted under this section be completed within 1 calendar day, as appropriate;

(h) Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 4 hours of issuance of the report. The presiding officer will then issue the final agency decision.

(i) Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding officer's report of the hearing and any comments on the report by the hearing participant under §1.403(h) are part of the administrative record.

(j) No party shall have the right, under §16.119 of this chapter to petition the Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer's final agency decision.

(k) If FDA grants a request for an informal hearing on an appeal of a detention order, the hearing must be conducted as a regulatory hearing pursuant to regulation in accordance with part 16 of this chapter, except that §16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in §§16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the exclusive record for the presiding officer's final decision on an administrative detention. For purposes of judicial review under §10.45 of this chapter, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.

The presiding officer for an appeal, and for an informal hearing, must be an FDA Regional Food and Drug Director or another FDA official senior to an FDA District Director.

(a) The presiding officer must issue a written report that includes a proposed decision confirming or revoking the detention by noon on the fifth calendar day after the appeal is filed; after your 4 hour opportunity for submitting comments under §1.403(h), the presiding officer must issue a final decision within the 5-calendar day period after the appeal is filed. If FDA either fails to provide you with an opportunity to request an informal hearing, or fails to confirm or terminate the detention order within the 5-calendar day period, the detention order is deemed terminated.

(b) If you appeal the detention order, but do not request an informal hearing, the presiding officer must issue a decision on the appeal confirming or revoking the detention within 5 calendar days after the date the appeal is filed. If the presiding officer fails to confirm or terminate the detention order during such 5-calendar day period, the detention order is deemed terminated.

(c) If you appeal the detention order and request an informal hearing and your hearing request is denied, the presiding officer must issue a decision on the appeal confirming or revoking the detention within 5 calendar days after the date the appeal is filed. If the presiding officer fails to confirm or terminate the detention order during such 5-calendar day period, the detention order is deemed terminated.

(d) If the presiding officer confirms a detention order, the article of food continues to be detained until we terminate the detention under §1.384 or the detention period expires under §1.379, whichever occurs first.

(e) If the presiding officer terminates a detention order, or the detention period expires, FDA must terminate the detention order as specified under §1.384.

(f) Confirmation of a detention order by the presiding officer is considered a final agency action for purposes of 5 U.S.C. 702.

Where the credible evidence or information supporting the detention order is classified under the applicable Executive order as requiring protection from unauthorized disclosure in the interest of national security (“classified information”), FDA will not provide you with this information. The presiding officer will give you notice of the general nature of the information and an opportunity to offer opposing evidence or information, if he or she may do so consistently with safeguarding the information and its source. If classified information was used to support the detention, then any confirmation of such detention will state whether it is based in whole or in part on that classified information.

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