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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:1.0.1.1.1.1.49.1 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | A | Subpart A—General Provisions | § 1.1 General. | FDA | [42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993; 75 FR 73953, Nov. 30, 2010; 78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug. 29, 2016] | (a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done. (b) The definitions and interpretations of terms contained in sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 and 387) shall be applicable also to such terms when used in regulations promulgated under that act. (c) The definition of package in § 1.20 and of principal display panel in §§ 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in §§ 101.7(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this chapter to type size requirements for net quantity declaration in §§ 101.7(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this chapter, to initial statement of ounces in the dual declaration of net quantity in §§ 101.7(j) and (m), 201.62(i) and (k), 501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial statement of inches in declaration of net quantity in §§ 201.62(m), 701.13(o) and 801.62(m) of this chapter, to initial statement of square inches in declaration of net quantity in §§ 201.62(n), 701.13(p) and 801.62(n) of this chapter, to prohibition of certain supplemental net quantity statements in §§ 101.7(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o) of this chapter, and to servings representations in § 501.8 of this chapter are provided for solely by the Fair Packaging and Labeling Act. The other requirements part of this part are issued under both the Fair Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act, or by the latter act solely, and are not limited in their application by section 10 of the Fair Packaging and Labeling Act. | |||
| 21:21:1.0.1.1.1.1.49.2 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | A | Subpart A—General Provisions | § 1.3 Definitions. | FDA | (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) Label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. | ||||
| 21:21:1.0.1.1.1.1.49.3 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | A | Subpart A—General Provisions | § 1.4 Authority citations. | FDA | [54 FR 39630, Sept. 27, 1989] | (a) For each part of its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is included in that part. (b) The agency may rely on any one or more of the authorities that are listed for a particular part in implementing or enforcing any section in that part. (c) All citations of authority in this chapter will list the applicable sections in the organic statute if the statute is the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair Packaging and Labeling Act. References to an act or a section thereof include references to amendments to that act or section. These citations will also list the corresponding United States Code (U.S.C.) sections. For example, a citation to section 701 of the Federal Food, Drug, and Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371). (d) If the organic statute is one other than those specified in paragraph (c) of this section, the citations of authority in this chapter generally will list only the applicable U.S.C. sections. For example, a citation to section 552 of the Administrative Procedure Act would be listed: 5 U.S.C. 552. The agency may, where it determines that such measures are in the interest of clarity and public understanding, list the applicable sections in the organic statute and the corresponding U.S.C. section in the same manner set out in paragraph (c) of this section. References to an act or a section thereof include references to amendments to that act or section. (e) Where there is no U.S.C. provision, the agency will include a citation to the U.S. Statutes at Large. Citations to the U.S. Statutes at Large will refer to volume and page. (f) The authority citations will include a citation to executive delegations (i.e., Executive Orders), if any, necessary to link the statutory authority to the agency. | |||
| 21:21:1.0.1.1.1.10.61.1 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.377 What definitions apply to this subpart? | FDA | [69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020] | 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 Division Director in whose division 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. | |||
| 21:21:1.0.1.1.1.10.61.2 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.378 What criteria does FDA use to order a detention? | FDA | [76 FR 25541, May 5, 2011] | 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 reason to believe that the article of food is adulterated or misbranded. | |||
| 21:21:1.0.1.1.1.10.61.3 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.379 How long may FDA detain an article of food? | FDA | (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. | ||||
| 21:21:1.0.1.1.1.10.61.4 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.380 Where and under what conditions must the detained article of food be held? | FDA | (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). | ||||
| 21:21:1.0.1.1.1.10.61.5 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.381 May a detained article of food be delivered to another entity or transferred to another location? | FDA | (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… | ||||
| 21:21:1.0.1.1.1.10.61.6 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.382 What labeling or marking requirements apply to a detained article of food? | FDA | 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. | ||||
| 21:21:1.0.1.1.1.10.61.7 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? | FDA | 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. | ||||
| 21:21:1.0.1.1.1.10.61.8 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.384 When does a detention order terminate? | FDA | 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. | ||||
| 21:21:1.0.1.1.1.10.62.10 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.392 Who receives a copy of the detention order? | FDA | (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. | ||||
| 21:21:1.0.1.1.1.10.62.11 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.393 What information must FDA include in the detention order? | FDA | [69 FR 31701, June 4, 2004, as amended at 76 FR 25541, May 5, 2011; 85 FR 16550, Mar. 24, 2020] | (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 reason to believe that such article of food is adulterated or misbranded. (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, email address, fax number, and the name of the FDA Division Director in whose division 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. | |||
| 21:21:1.0.1.1.1.10.62.9 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.391 Who approves a detention order? | FDA | [69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020] | An authorized FDA representative 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. | |||
| 21:21:1.0.1.1.1.10.63.12 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.401 Who is entitled to appeal? | FDA | 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.” | ||||
| 21:21:1.0.1.1.1.10.63.13 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.402 What are the requirements for submitting an appeal? | FDA | [69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020] | (a) If you want to appeal a detention order, you must submit your appeal in writing to the FDA Division Director in whose division the detained article of food is located, at the mailing address, email 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. | |||
| 21:21:1.0.1.1.1.10.63.14 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.403 What requirements apply to an informal hearing? | FDA | [69 FR 31701, June 4, 2004, as amended at 82 FR 14144, Mar. 17, 2017; 85 FR 16550, Mar. 24, 2020] | 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 Division Director in whose division 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 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 wit… | |||
| 21:21:1.0.1.1.1.10.63.15 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.404 Who serves as the presiding officer for an appeal and for an informal hearing? | FDA | [85 FR 16550, Mar. 24, 2020] | The presiding officer for an appeal, and for an informal hearing, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA Division Director. | |||
| 21:21:1.0.1.1.1.10.63.16 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.405 When does FDA have to issue a decision on an appeal? | FDA | (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. | ||||
| 21:21:1.0.1.1.1.10.63.17 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | K | Subpart K—Administrative Detention of Food for Human or Animal Consumption | § 1.406 How will FDA handle classified information in an informal hearing? | FDA | 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. | ||||
| 21:21:1.0.1.1.1.11.64.1 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.500 What definitions apply to this subpart? | FDA | [80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016] | The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part. Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. Audit means the systematic, independent, and documented examination (through observation, investigation, discussions with employees of the audited entity, records review, and, as appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes and procedures. Dietary supplement has the meaning given in section 201(ff) of the Federal Food, Drug, and Cosmetic Act. Dietary supplement component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Dietary supplement components include dietary ingredients (as described in section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other ingredients. Environmental pathogen means a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria. Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of subpart H of this part. Farm means farm as defined in § 1.227. Farm mixed-type facility means an establishment that is a farm but that also conducts activities outside the farm definition that require the establishment to be registered under section 415 of the Federal Food, Drug, and Cosmeti… | |||
| 21:21:1.0.1.1.1.11.64.10 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.509 How must the importer be identified at entry? | FDA | (a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection. (b) Before an article of food is imported or offered for import into the United States, the foreign owner or consignee of the food (if there is no U.S. owner or consignee) must designate a U.S. agent or representative as the importer of the food for the purposes of the definition of “importer” in § 1.500. | ||||
| 21:21:1.0.1.1.1.11.64.11 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.510 How must I maintain records of my FSVP? | FDA | (a) General requirements for records. (1) You must keep records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records. (2) You must sign and date records concerning your FSVP upon initial completion and upon any modification of the FSVP. (3) All records must be legible and stored to prevent deterioration or loss. (b) Record availability. (1) You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English. (2) Offsite storage of records, including records maintained by other entities in accordance with § 1.504, § 1.505, or § 1.506, is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location. (3) If requested in writing by FDA, you must send records to the Agency electronically, or through another means that delivers the records promptly, rather than making the records available for review at your place of business. (c) Record retention. (1) Except as specified in paragraph (c)(2) of this section, you must retain records referenced in this subpart until at least 2 years after you created or obtained the records. (2) You must retain records that relate to your processes and procedures, including the results of evaluations and determinations you conduct, for at least 2 years after their use is discontinued ( e.g., because you no longer import a particular food, you no longer use a particular foreign supplier, you have reevaluated the risks associated with a food and the foreign supplier, or you have changed your supplier verification activities for a particular food and foreign supplier). (d) Electronic rec… | ||||
| 21:21:1.0.1.1.1.11.64.12 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation? | FDA | [80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016] | (a) Importers subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If you are required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you import for further manufacturing, processing, or packaging as a dietary supplement, and you are in compliance with the requirements in §§ 111.73 and 111.75 of this chapter applicable to determining whether the specifications you established are met for such food, then for that food you must comply with the requirements in §§ 1.503 and 1.509, but you are not required to comply with the requirements in § 1.502, §§ 1.504 through 1.508, or § 1.510. This requirement does not limit your obligations with respect to part 111 of this chapter or any other laws enforced by FDA. (b) Importers whose customer is subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If your customer is required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you import for further manufacturing, processing, or packaging as a dietary supplement, your customer is in compliance with the requirements of §§ 111.73 and 111.75 of this chapter applicable to determining whether the specifications it established are met for such food, and you annually obtain from your customer written assurance that it is in compliance with those requirements, then for that food you must comply with the requirements in §§ 1.503, 1.509, and 1.510, but you are not required to comply with the requirements in § 1.502 or §§ 1.504 through 1.508. (c) Other importers of dietary supplements —(1) General. If the food you import is a dietary supplement and neither paragraph (a) or (b) of this section is applicable, you must comply with paragraph (c) of this section and the requirements in §§ 1.503, 1.505(a)(1)(ii) through (iv),… | |||
| 21:21:1.0.1.1.1.11.64.13 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers? | FDA | [80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016] | (a) Eligibility. This section applies only if: (1) You are a very small importer; or (2) You are importing certain food from certain small foreign suppliers as follows: (i) The foreign supplier is a qualified facility as defined by § 117.3 or § 507.3 of this chapter; (ii) You are importing produce from a foreign supplier that is a farm that grows produce and is not a covered farm under part 112 of this chapter in accordance with § 112.4(a) of this chapter, or in accordance with §§ 112.4(b) and 112.5 of this chapter; or (iii) You are importing shell eggs from a foreign supplier that is not subject to the requirements of part 118 of this chapter because it has fewer than 3,000 laying hens. (b) Applicable requirements —(1) Documentation of eligibility —(i) Very small importer status. (A) If you are a very small importer and you choose to comply with the requirements in this section, you must document that you meet the definition of very small importer in § 1.500 with respect to human food and/or animal food before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year. (B) For the purpose of determining whether you satisfy the definition of very small importer with respect to human food and/or animal food for a given calendar year, the relevant 3-year period of sales (and U.S. market value of human or animal food, as appropriate) is the period ending 1 year before the calendar year for which you intend to import food as a very small importer. The baseline year for calculating the adjustment for inflation is 2011. If you conduct any food sales in currency other than U.S. dollars, you must use the relevant currency exchange rate in effect on December 31 of the year in which sales occurred to calculate the value of these sales. (ii) Small foreign supplier status. If you are a importing food from a small foreign supplier as specified in paragraph (a)(2) of this section and you choose to comply with the requirements in this section, you mus… | |||
| 21:21:1.0.1.1.1.11.64.14 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system? | FDA | (a) General. (1) If you meet the conditions and requirements of paragraph (b) of this section for a food of the type specified in paragraph (a)(2) of this section that you are importing, then you are not required to comply with the requirements in §§ 1.504 through 1.508. You would still be required to comply with the requirements in §§ 1.503, 1.509, and 1.510. (2) This section applies to food that is not intended for further manufacturing/processing, including packaged food products and raw agricultural commodities that will not be commercially processed further before consumption. (b) Conditions and requirements. (1) Before importing a food from the foreign supplier and annually thereafter, you must document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of that official recognition or equivalency determination. (2) Before importing a food from the foreign supplier, you must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located. You must continue to monitor whether the foreign supplier is in good compliance standing and promptly review any information obtained. If the information indicates that food safety hazards associated with the food are not being significantly minimized or prevented, you must take prompt corrective action. The appropriate corrective action will depend on the circumstances but could include discontinuing use of the foreign supplier. You must document any corrective actions that you undertake in accordance with this paragraph (b)(2). | ||||
| 21:21:1.0.1.1.1.11.64.15 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.514 What are some consequences of failing to comply with the requirements of this subpart? | FDA | (a) Refusal of admission. An article of food is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if it appears that the importer of that food fails to comply with this subpart with respect to that food. If there is no U.S. owner or consignee of an article of food at the time the food is offered for entry into the United States, the article of food may not be imported into the United States unless the foreign owner or consignee has appropriately designated a U.S. agent or representative as the importer in accordance with § 1.500. (b) Prohibited act. The importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act, including the requirements of this subpart, is prohibited under section 301(zz) of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:1.0.1.1.1.11.64.2 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.501 To what foods do the requirements in this subpart apply? | FDA | [80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016] | (a) General. Except as specified otherwise in this section, the requirements in this subpart apply to all food imported or offered for import into the United States and to the importers of such food. (b) Exemptions for juice and seafood —(1) Importers of certain juice and seafood products. This subpart does not apply with respect to juice, fish, and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, the requirements in part 120 or part 123 of this chapter. If you import juice or fish and fishery products that are subject to part 120 or part 123, respectively, you must comply with the requirements applicable to importers of those products under § 120.14 or § 123.12 of this chapter, respectively. (2) Certain importers of juice or seafood raw materials or other ingredients subject to part 120 or part 123 of this chapter. This subpart does not apply with respect to any raw materials or other ingredients that you import and use in manufacturing or processing juice subject to part 120 or fish and fishery products subject to part 123, provided that you are in compliance with the requirements in part 120 or part 123 with respect to the juice or fish or fishery product that you manufacture or process from the imported raw materials or other ingredients. (c) Exemption for food imported for research or evaluation. This subpart does not apply to food that is imported for research or evaluation use, provided that such food: (1) Is not intended for retail sale and is not sold or distributed to the public; (2) Is labeled with the statement “Food for research or evaluation use”; (3) Is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of; and (4) Is accompanied, when filing entry with U.S. Customs and Border Protection, by an electronic declaration that the food will be used for research or evaluation purpose… | |||
| 21:21:1.0.1.1.1.11.64.3 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.502 What foreign supplier verification program (FSVP) must I have? | FDA | (a) General. Except as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act. (b) Low-acid canned foods —(1) Importers of low-acid canned foods not subject to further manufacturing or processing. With respect to those microbiological hazards that are controlled by part 113 of this chapter, if you import a thermally processed low-acid food packaged in a hermetically sealed container (low-acid canned food), you must verify and document that the food was produced in accordance with part 113. With respect to all matters that are not controlled by part 113, you must have an FSVP as specified in paragraph (a) of this section. (2) Certain importers of raw materials or other ingredients subject to part 113 of this chapter. With respect to microbiological hazards that are controlled by part 113, you are not required to comply with the requirements of this subpart for raw materials or other ingredients that you import and use in the manufacturing or processing of low-acid canned food provided that you are in compliance with part 113 with respect to the low-acid canned food that you manufacture or process from the imported raw materials or other ingredients. With respect to all hazards other than microbiological hazards that are controlled by part 113, you must have an FSVP as specified in paragraph (a) o… | ||||
| 21:21:1.0.1.1.1.11.64.4 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.503 Who must develop my FSVP and perform FSVP activities? | FDA | (a) Qualified individual. A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity. (b) Qualified auditor. A qualified auditor must conduct any audit conducted in accordance with § 1.506(e)(1)(i) or § 1.511(c)(5)(i)(A). A qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function. | ||||
| 21:21:1.0.1.1.1.11.64.5 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.504 What hazard analysis must I conduct? | FDA | (a) Requirement for a hazard analysis. Except as specified in paragraph (d) of this section, you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control. Your hazard analysis must be written regardless of its outcome. (b) Hazard identification. (1) Your analysis of the known or reasonably foreseeable hazards in each food must include the following types of hazards: (i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens; (ii) Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and (iii) Physical hazards (such as stones, glass, and metal fragments). (2) Your analysis must include known or reasonably foreseeable hazards that may be present in a food for any of the following reasons: (i) The hazard occurs naturally; (ii) The hazard may be unintentionally introduced; or (iii) The hazard may be intentionally introduced for purposes of economic gain. (c) Hazard evaluation. (1) Your hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur. (2) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a treatment or otherwise include a control or measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. (3) Your hazard evaluation must consider the effect… | ||||
| 21:21:1.0.1.1.1.11.64.6 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.505 What evaluation for foreign supplier approval and verification must I conduct? | FDA | (a) Evaluation of a foreign supplier's performance and the risk posed by a food. (1) Except as specified in paragraphs (d) and (e) of this section, in approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you must consider the following: (i) The hazard analysis of the food conducted in accordance with § 1.504, including the nature of the hazard requiring a control. (ii) The entity or entities that will be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, such as the foreign supplier, the foreign supplier's raw material or other ingredient supplier, or another entity in your supply chain. (iii) Foreign supplier performance, including: (A) The foreign supplier's procedures, processes, and practices related to the safety of the food; (B) Applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety (or, when applicable, the relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and information relevant to the supplier's compliance with those laws and regulations); and (C) The foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems. (iv) Any other factors as appropriate and necessary, such as storage and transportation practices. (2) You must document the evaluation you conduct under paragraph (a)(1) of this section. (b) Approval of foreign suppliers. You must approve your foreign suppliers … | ||||
| 21:21:1.0.1.1.1.11.64.7 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.506 What foreign supplier verification and related activities must I conduct? | FDA | (a) Use of approved foreign suppliers. (1) You must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under § 1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures. (2) You may rely on an entity other than your foreign supplier to establish the procedures and perform and document the activities required under paragraph (a)(1) of this section provided that you review and assess that entity's documentation of the procedures and activities, and you document your review and assessment. (b) Foreign supplier verification procedures. You must establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import. (c) Requirement of supplier verification. The foreign supplier verification activities must provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. (d) Determination of appropriate foreign supplier verification activities —(1)(i) General. Except as provided in paragraphs (d)(2) and (3) of this section, before importing a food from a foreign supplier, you must determine and document which verification activity or activities listed in paragraphs (d)(1)(ii)(A) through (D) of this section, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with paragraph (c) of this section. Verification activities must address the entity or entities that are significantly minimizing or preventing the hazards or verifying that the hazards have been significantly minimized or prevented ( e.g., when an entity other than the grower… | ||||
| 21:21:1.0.1.1.1.11.64.8 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation? | FDA | (a) Circumstances. You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply: (1) You determine and document that the type of food ( e.g., raw agricultural commodities such as cocoa beans and coffee beans) could not be consumed without application of an appropriate control; (2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to ensure that the identified hazard will be significantly minimized or prevented and you: (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance, subject to the requirements of paragraph (c) of this section, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard; (3) You rely on your customer who is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to provide assurance it is manufacturing, processing, or preparing the food in accordance with the applicable food safety requirements and you: (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance that it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements; (4) You rely on your customer to provide assurance that the food will be processed to control the identified hazard by an entity in the distribution chain s… | ||||
| 21:21:1.0.1.1.1.11.64.9 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | L | Subpart L—Foreign Supplier Verification Programs for Food Importers | § 1.508 What corrective actions must I take under my FSVP? | FDA | (a) You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under § 1.506 or § 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under § 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with this paragraph. (b) If you determine, by means other than the verification activities conducted under § 1.506 or § 1.511(c) or a reevaluation conducted under § 1.505(c) or (d), that a foreign supplier of food that you import does not produce food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act, you must promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP. You must document any investigations, corrective actions, and changes to your FS… | ||||
| 21:21:1.0.1.1.1.12.64.1 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.600 What definitions apply to this subpart? | FDA | (a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act. (b) Except as otherwise defined in paragraph (c) of this section, the definitions of terms in section 201 of the FD&C Act apply when the terms are used in this subpart. (c) In addition, for the purposes of this subpart: Accreditation means a determination by a recognized accreditation body (or, in the case of direct accreditation, by FDA) that a third-party certification body meets the applicable requirements of this subpart. Accreditation body means an authority that performs accreditation of third-party certification bodies. Accredited third-party certification body means a third-party certification body that a recognized accreditation body (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of this subpart and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. An accredited third-party certification body has the same meaning as accredited third-party auditor as defined in section 808(a)(4) of the FD&C Act. Assessment means: (i) With respect to an accreditation body, an evaluation by FDA of the competency and capacity of the accreditation body under the applicable requirements of this subpart for the defined scope of recognition. An assessment of the competency and capacity of the accreditation body involves evaluating the competency and capacity of the operations of the accreditation body that are relevant to decisions on recognition and, if recognized, an evaluation of its performance and the validity of its accreditation decisions under the applicable requirements of this subpart. (ii) With respect to a third-party certification body, an evaluation by a recognized accreditation body (or, in the case of direct accreditation, FDA) of the competency and capacity of a third-party certification body under the applicable requirements of this subpart for the defined scope of accreditation. An assessment of the competency and capacity o… | ||||
| 21:21:1.0.1.1.1.12.64.2 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.601 Who is subject to this subpart? | FDA | (a) Accreditation bodies. Any accreditation body seeking recognition from FDA to accredit third-party certification bodies to conduct food safety audits and to issue food and facility certifications under this subpart. (b) Third-party certification bodies. Any third-party certification body seeking accreditation from a recognized accreditation body or direct accreditation by FDA for: (1) Conducting food safety audits; and (2) Issuing certifications that may be used in satisfying a condition of admissibility of an article of food under section 801(q) of the FD&C Act; or issuing a facility certification for meeting the eligibility requirements for the Voluntary Qualified Importer Program under section 806 of the FD&C Act. (c) Eligible entities. Any eligible entity seeking a food safety audit or a food or facility certification from an accredited third-party certification body under this subpart. (d) Limited exemptions from section 801(q) of the FD&C Act —(1) Alcoholic beverages. (i) Any certification required under section 801(q) of the FD&C Act does not apply with respect to alcoholic beverages from an eligible entity that is a facility that meets the following two conditions: (A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq. ) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq. ), the facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and (B) Under section 415 of the FD&C Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages. (ii) Any certification required under section 801(q) of the FD&C Act does not apply with respect to food that is not an alcoholic beverage that is received and distributed by a facility described in paragraph (d)… | ||||
| 21:21:1.0.1.1.1.12.64.3 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.610 Who is eligible to seek recognition? | FDA | An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it meets the requirements of §§ 1.611 through 1.615. The accreditation body may use documentation of conformance with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17011:2004, supplemented as necessary, in meeting the applicable requirements of this subpart. | ||||
| 21:21:1.0.1.1.1.12.64.4 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.611 What legal authority must an accreditation body have to qualify for recognition? | FDA | (a) An accreditation body seeking recognition must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform assessments of a third-party certification body as are necessary to determine its capability to conduct audits and certify food facilities and food, including authority to: (1) Review any relevant records; (2) Conduct onsite assessments of the performance of third-party certification bodies, such as by witnessing the performance of a representative sample of its agents (or, in the case of a third-party certification body that is an individual, such individual) conducting a representative sample of audits; (3) Perform any reassessments or surveillance necessary to monitor compliance of accredited third-party certification bodies; and (4) Suspend, withdraw, or reduce the scope of accreditation for failure to comply with the requirements of accreditation. (b) An accreditation body seeking recognition must demonstrate that it is capable of exerting the authority (as a governmental entity or as a legal entity with contractual rights) necessary to meet the applicable requirements of this subpart, if recognized. | ||||
| 21:21:1.0.1.1.1.12.64.5 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.612 What competency and capacity must an accreditation body have to qualify for recognition? | FDA | An accreditation body seeking recognition must demonstrate that it has: (a) The resources required to adequately implement its accreditation program, including: (1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively evaluate the qualifications of third-party certification bodies seeking accreditation and to effectively monitor the performance of accredited third-party certification bodies; and (2) Adequate financial resources for its operations; and (b) The capability to meet the applicable assessment and monitoring requirements, the reporting and notification requirements, and the procedures of this subpart, if recognized. | ||||
| 21:21:1.0.1.1.1.12.64.6 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition? | FDA | An accreditation body must demonstrate that it has: (a) Implemented written measures to protect against conflicts of interest between the accreditation body (and its officers, employees, and other agents involved in accreditation activities) and any third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) seeking accreditation from, or accredited by, such accreditation body; and (b) The capability to meet the applicable conflict of interest requirements of this subpart, if recognized. | ||||
| 21:21:1.0.1.1.1.12.64.7 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition? | FDA | An accreditation body seeking recognition must demonstrate that it has: (a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents and its accreditation program, including procedures to: (1) Identify areas in its accreditation program or performance where deficiencies exist; and (2) Quickly execute corrective actions that effectively address deficiencies when identified; and (b) The capability to meet the applicable quality assurance requirements of this subpart, if recognized. | ||||
| 21:21:1.0.1.1.1.12.64.8 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.615 What records procedures must an accreditation body have to qualify for recognition? | FDA | An accreditation body seeking recognition must demonstrate that it has: (a) Implemented written procedures to establish, control, and retain records (including documents and data) for the period of time necessary to meet its contractual and legal obligations pertaining to this subpart and to provide an adequate basis for evaluating its program and performance; and (b) The capability to meet the applicable reporting and notification requirements of this subpart, if recognized. | ||||
| 21:21:1.0.1.1.1.12.65.10 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited? | FDA | (a) A recognized accreditation body must annually conduct a comprehensive assessment of the performance of each third-party certification body it accredited under this subpart by reviewing the accredited third-party certification body's self-assessments (including information on compliance with the conflict of interest requirements of §§ 1.643 and 1.657); its regulatory audit reports and notifications submitted to FDA under § 1.656; and any other information reasonably available to the recognized accreditation body regarding the compliance history of eligible entities the accredited third-party certification body certified under this subpart; or that is otherwise relevant to a determination whether the accredited third-party certification body is in compliance with this subpart. (b) No later than 1 year after the initial date of accreditation of the third-party certification body and every 2 years thereafter for duration of its accreditation under this subpart, a recognized accreditation body must conduct onsite observations of a representative sample of regulatory audits performed by the third-party certification body (or its audit agents) (or, in the case of a third-party certification body that is an individual, such individual) accredited under this subpart and must visit the accredited third-party certification body's headquarters (or other location that manages audit agents conducting food safety audits under this subpart, if different than its headquarters). The recognized accreditation body will consider the results of such observations and visits in the annual assessment of the accredited third-party certification body required by paragraph (a) of this section. | ||||
| 21:21:1.0.1.1.1.12.65.11 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.622 How must a recognized accreditation body monitor its own performance? | FDA | (a) A recognized accreditation body must annually, and as required under § 1.664(g), conduct a self-assessment that includes evaluation of compliance with this subpart, including: (1) The performance of its officers, employees, or other agents involved in accreditation activities and the degree of consistency in conducting accreditation activities; (2) The compliance of the recognized accreditation body and its officers, employees, and other agents involved in accreditation activities, with the conflict of interest requirements of § 1.624; and (3) If requested by FDA, any other aspects of its performance relevant to a determination whether the recognized accreditation body is in compliance with this subpart. (b) As a means to evaluate the recognized accreditation body's performance, the self-assessment must include onsite observation of regulatory audits of a representative sample of third-party certification bodies it accredited under this subpart. In meeting this requirement, the recognized accreditation body may use the results of onsite observations performed under § 1.621(b). (c) Based on the evaluations conducted under paragraphs (a) and (b) of this section, the recognized accreditation body must: (1) Identify any area(s) where deficiencies exist; (2) Quickly implement corrective action(s) that effectively address those deficiencies; and (3) Establish and maintain records of any such corrective action(s) under § 1.625. (d) The recognized accreditation body must prepare, and as required by § 1.623(b) submit, a written report of the results of its self-assessment that includes the following elements. Documentation of conformance to ISO/IEC 17011:2004 may be used, supplemented as necessary, in meeting the requirements of this paragraph. (1) A description of any corrective actions taken under paragraph (c) of this section; (2) A statement disclosing the extent to which the recognized accreditation body, and its officers, employees, and other agents involved in accreditation activities, complied with … | ||||
| 21:21:1.0.1.1.1.12.65.12 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.623 What reports and notifications must a recognized accreditation body submit to FDA? | FDA | (a) Reporting results of assessments of accredited third-party certification body performance. A recognized accreditation body must submit to FDA electronically, in English, a report of the results of any assessment conducted under § 1.621, no later than 45 days after completing such assessment. The report must include an up-to-date list of any audit agents used by the accredited third-party certification body to conduct food safety audits under this subpart. (b) Reporting results of recognized accreditation body self-assessments. A recognized accreditation body must submit to FDA electronically, in English: (1) A report of the results of an annual self-assessment required under § 1.622, no later than 45 days after completing such self-assessment; and (2) For a recognized accreditation body subject to § 1.664(g)(1), a report of such self-assessment to FDA within 60 days of the third-party certification body's withdrawal. A recognized accreditation body may use a report prepared for conformance to ISO/IEC 17011:2004, supplemented as necessary, in meeting the requirements this section. (c) Immediate notification to FDA. A recognized accreditation body must notify FDA electronically, in English, immediately upon: (1) Granting (including expanding the scope of) accreditation to a third-party certification body under this subpart, and include: (i) The name, address, telephone number, and email address of the accredited third-party certification body; (ii) The name of one or more officers of the accredited third-party certification body; (iii) A list of the accredited third-party certification body's audit agents; and (iv) The scope of accreditation, the date on which it was granted, and its expiration date. (2) Withdrawing, suspending, or reducing the scope of an accreditation under this subpart, and include: (i) The basis for such action; and (ii) Any additional changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section. (3) Determining that a third-part… | ||||
| 21:21:1.0.1.1.1.12.65.13 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.624 How must a recognized accreditation body protect against conflicts of interest? | FDA | (a) A recognized accreditation body must implement a written program to protect against conflicts of interest between the recognized accreditation body (and its officers, employees, and other agents involved in accreditation activities) and any third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) seeking accreditation from, or accredited by, such recognized accreditation body, including the following: (1) Ensuring that the recognized accreditation body (and its officers, employees, or other agents involved in accreditation activities) does not own or have a financial interest in, manage, or otherwise control the third-party certification body (or any affiliate, parent, or subsidiary); and (2) Prohibiting officers, employees, or other agents involved in accreditation activities of the recognized accreditation body from accepting any money, gift, gratuity, or item of value from the third-party certification body. (3) The items specified in paragraph (a)(2) of this section do not include: (i) Money representing payment of fees for accreditation services and reimbursement of direct costs associated with an onsite assessment of the third-party certification body; or (ii) Lunch of de minimis value provided during the course of an assessment and on the premises where the assessment is conducted, if necessary to facilitate the efficient conduct of the assessment. (b) A recognized accreditation body may accept the payment of fees for accreditation services and the reimbursement of direct costs associated with assessment of a certification body only after the date on which the report of such assessment was completed or the date of which the accreditation was issued, whichever comes later. Such payment is not considered a conflict of interest for purposes of paragraph (a) of this section. (c) The financial interests of the spouses and children younger than 18 years of age of a recognized accreditation body's officers, employees, and other age… | ||||
| 21:21:1.0.1.1.1.12.65.14 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.625 What records requirements must an accreditation body that has been recognized meet? | FDA | (a) An accreditation body that has been recognized must maintain electronically for 5 years records created while it is recognized (including documents and data) demonstrating its compliance with this subpart, including records relating to: (1) Applications for accreditation and renewal of accreditation under § 1.660; (2) Decisions to grant, deny, suspend, withdraw, or expand or reduce the scope of an accreditation; (3) Challenges to adverse accreditation decisions under § 1.620(c); (4) Its monitoring of accredited third-party certification bodies under § 1.621; (5) Self-assessments and corrective actions under § 1.622; (6) Regulatory audit reports, including any supporting information, that an accredited third-party certification body may have submitted; (7) Any reports or notifications to FDA under § 1.623, including any supporting information; and (8) Records of fee payments and reimbursement of direct costs. (b) An accreditation body that has been recognized must make records required by paragraph (a) of this section available for inspection and copying promptly upon written request of an authorized FDA officer or employee at the place of business of the accreditation body or at a reasonably accessible location. If the records required by paragraph (a) of this section are requested by FDA electronically, the records must be submitted to FDA electronically not later than 10 business days after the date of the request. Additionally, if the requested records are maintained in a language other than English, the accreditation body must electronically submit an English translation within a reasonable time. (c) An accreditation body that has been recognized must not prevent or interfere with FDA's access to its accredited third-party certification bodies and the accredited third-party certification body records required by § 1.658. | ||||
| 21:21:1.0.1.1.1.12.65.9 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation? | FDA | (a) Prior to accrediting a third-party certification body under this subpart, a recognized accreditation body must perform, at a minimum, the following: (1) In the case of a foreign government or an agency of a foreign government, such reviews and audits of the government's or agency's food safety programs, systems, and standards as are necessary to determine that it meets the eligibility requirements of § 1.640(b). (2) In the case of a foreign cooperative or any other third-party seeking accreditation as a third-party certification body, such reviews and audits of the training and qualifications of agents conducting audits for such cooperative or other third party (or in the case of a third-party certification body that is an individual, such individual) and such reviews of internal systems and any other investigation of the cooperative or other third party necessary to determine that it meets the eligibility requirements of § 1.640(c). (3) In conducting a review and audit under paragraph (a)(1) or (2) of this section, an observation of a representative sample of onsite audits examining compliance with the applicable food safety requirements of the FD&C Act and FDA regulations as conducted by the third-party certification body or its agents (or, in the case of a third-party certification body that is an individual, such individual). (b) A recognized accreditation body must require a third-party certification body, as a condition of accreditation under this subpart, to comply with the reports and notification requirements of §§ 1.652 and 1.656 and to agree to submit to FDA, electronically and in English, any food or facility certifications it issues for purposes of sections 801(q) or 806 of the FD&C Act. (c) A recognized accreditation body must maintain records on any denial of accreditation (in whole or in part) and on any withdrawal, suspension, or reduction in scope of accreditation of a third-party certification body under this subpart. The records must include the name and contact information for the th… | ||||
| 21:21:1.0.1.1.1.12.66.15 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.630 How do I apply to FDA for recognition or renewal of recognition? | FDA | (a) Applicant for recognition. An accreditation body seeking recognition must submit an application demonstrating that it meets the eligibility requirements in § 1.610. (b) Applicant for renewal of recognition. An accreditation body seeking renewal of its accreditation must submit a renewal application demonstrating that it continues to meet the requirements of this subpart. (c) Submission. Recognition and renewal applications and any documents provided as part of the application process must be submitted electronically, in English. An applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during onsite assessments of the applicant by FDA. (d) Signature. Recognition and renewal applications must be signed in the manner designated by FDA, by an individual authorized to act on behalf of the applicant for purposes of seeking recognition or renewal of recognition. | ||||
| 21:21:1.0.1.1.1.12.66.16 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application? | FDA | (a) Review of recognition or renewal application. FDA will examine an accreditation body's recognition or renewal application for completeness and notify the applicant of any deficiencies. FDA will review an accreditation body's recognition or renewal application on a first in, first out basis according to the date on which the completed application was submitted; however, FDA may prioritize the review of specific applications to meet the needs of the program. (b) Evaluation of recognition or renewal. FDA will evaluate any completed recognition or renewal application to determine whether the applicant meets the applicable requirements of this subpart. Such evaluation may include an onsite assessment of the accreditation body. FDA will notify the applicant, in writing, regarding whether the application has been approved or denied. FDA may make such notification electronically. If FDA does not reach a final decision on a renewal application before an accreditation body's recognition terminates by expiration, FDA may extend such recognition for a specified period of time or until the Agency reaches a final decision on the renewal application. (c) Issuance of recognition. FDA will notify an applicant that its recognition or renewal application has been approved through issuance of recognition that will list any limitations associated with the recognition. (d) Issuance of denial of recognition or renewal application. FDA will notify an applicant that its recognition or renewal application has been denied through issuance of a denial of recognition or denial of a renewal application that will state the basis for such denial and provide the procedures for requesting reconsideration of the application under § 1.691. (e) Notice of records custodian after denial of an application for renewal of recognition. An applicant whose renewal application was denied must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of a renewal application, of the name and contact i… | ||||
| 21:21:1.0.1.1.1.12.66.17 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.632 What is the duration of recognition? | FDA | FDA may grant recognition of an accreditation body for a period not to exceed 5 years from the date of recognition. | ||||
| 21:21:1.0.1.1.1.12.66.18 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.633 How will FDA monitor recognized accreditation bodies? | FDA | (a) FDA will evaluate the performance of each recognized accreditation body to determine its compliance with the applicable requirements of this subpart. Such assessment must occur by at least 4 years after the date of recognition for a 5-year recognition period, or by no later than the mid-term point for a recognition period of less than 5 years. FDA may conduct additional assessments of a recognized accreditation body at any time. (b) An FDA assessment of a recognized accreditation body may include onsite assessments of a representative sample of third-party certification bodies the recognized accreditation body accredited and onsite audits of a representative sample of eligible entities certified by such third-party certification bodies under this subpart. These may be conducted at any time and, as FDA determines necessary or appropriate, may occur without the recognized accreditation body or, in the case of an audit of an eligible entity, the accredited third-party certification body present. | ||||
| 21:21:1.0.1.1.1.12.66.19 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.634 When will FDA revoke recognition? | FDA | [80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016] | (a) Grounds for revocation of recognition. FDA will revoke the recognition of an accreditation body found not to be in compliance with the requirements of this subpart, including for any one or more of the following: (1) Refusal by the accreditation body to allow FDA to access records required by § 1.625, or to conduct an assessment or investigation of the accreditation body or of a third-party certification body it accredited to ensure the accreditation body's continued compliance with the requirements of this subpart. (2) Failure to take timely and necessary corrective action when: (i) The accreditation of a third-party certification body it accredited is withdrawn by FDA under § 1.664(a); (ii) A significant deficiency is identified through self-assessment under § 1.622, monitoring under § 1.621, or self-assessment by one or more of its accredited third-party certification bodies under § 1.655; or (iii) Directed to do so by FDA to ensure compliance with this subpart. (3) A determination by FDA that the accreditation body has committed fraud or has submitted material false statements to the Agency. (4) A determination by FDA that there is otherwise good cause for revocation, including: (i) Demonstrated bias or lack of objectivity when conducting activities under this subpart; or (ii) Failure to adequately support one or more decisions to grant accreditation under this subpart. (iii) Failure to pay the annual user fee within 90 days of the payment due date, as specified in § 1.725(b)(3). (b) Records request associated with revocation. To assist in determining whether revocation is warranted under paragraph (a) of this section, FDA may request records of the accreditation body required by § 1.625 or the records, required by § 1.658, of one or more of the third-party certification bodies it accredited under this subpart. (c) Issuance of revocation of recognition. (1) FDA will notify an accreditation body that its recognition has been revoked through issuance of a revocation that will state the gro… | |||
| 21:21:1.0.1.1.1.12.66.20 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition? | FDA | (a) Notice to FDA of intent to relinquish or not to renew recognition. A recognized accreditation body must notify FDA electronically, in English, at least 60 days before voluntarily relinquishing recognition or before allowing recognition to expire without seeking renewal. The recognized accreditation body must provide the name and contact information of the custodian who will maintain the records required under § 1.625(a) after the date of relinquishment or the date recognition expires, as applicable, and make them available to FDA as required by § 1.625(b). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by § 1.625(a) will be located. (b) Notice to accredited third-party certification bodies of intent to relinquish or not to renew recognition. No later than 15 business days after notifying FDA under paragraph (a) of this section, the recognized accreditation body must notify any currently accredited third-party certification body that it intends to relinquish recognition or to allow its recognition to expire, specifying the date on which relinquishment or expiration will occur. The recognized accreditation body must establish and maintain records of such notification under § 1.625. (c)(1) Effect of voluntary relinquishment or expiration of recognition on third-party certification bodies. The accreditation of a third-party certification body issued prior to the relinquishment or expiration of its accreditation body's recognition will remain in effect, so long as the third-party certification body: (i) No later than 60 days after the date of relinquishment or the date of expiration of the recognition, conducts a self-assessment under § 1.655 and reports the results of the self-assessment to FDA under § 1.656(b); and (ii) No later than 1 year after the date of relinquishment or the date of expiration of recognition, or the original date of the expiration of the accreditation, whichever comes first, becomes accredi… | ||||
| 21:21:1.0.1.1.1.12.66.21 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.636 How do I request reinstatement of recognition? | FDA | (a) Application following revocation. An accreditation body that has had its recognition revoked may seek reinstatement by submitting a new application for recognition under § 1.630. The accreditation body must submit evidence that the grounds for revocation have been resolved, including evidence addressing the cause or conditions that were the basis for revocation and identifying measures that have been implemented to help ensure that such cause(s) or condition(s) are unlikely to recur. (b) Application following relinquishment. An accreditation body that previously relinquished its recognition under § 1.635 may seek recognition by submitting a new application for recognition under § 1.630. | ||||
| 21:21:1.0.1.1.1.12.67.22 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.640 Who is eligible to seek accreditation? | FDA | (a) A foreign government, agency of a foreign government, foreign cooperative, or any other third party may seek accreditation from a recognized accreditation body (or, where direct accreditation is appropriate, FDA) to conduct food safety audits and to issue food and facility certifications to eligible entities under this subpart. An accredited third-party certification body may use documentation of conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012, supplemented as necessary, in meeting the applicable requirements of this subpart. (b) A foreign government or an agency of a foreign government is eligible for accreditation if it can demonstrate that its food safety programs, systems, and standards meet the requirements of §§ 1.641 through 1.645. (c) A foreign cooperative or other third party is eligible for accreditation if it can demonstrate that the training and qualifications of its agents used to conduct audits (or, in the case of a third-party certification body that is an individual, such individual) and its internal systems and standards meet the requirements of §§ 1.641 through 1.645. | ||||
| 21:21:1.0.1.1.1.12.67.23 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.641 What legal authority must a third-party certification body have to qualify for accreditation? | FDA | (a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) as are necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and conformance with applicable industry standards and practices and to issue certifications where appropriate based on a review of the findings of such examinations. This includes authority to: (1) Review any relevant records; (2) Conduct onsite audits of an eligible entity; and (3) Suspend or withdraw certification for failure to comply with applicable requirements. (b) A third-party certification body seeking accreditation must demonstrate that it is capable of exerting the authority (as a governmental entity or as legal entity with contractual rights) necessary to meet the applicable requirements of accreditation under this subpart if accredited. | ||||
| 21:21:1.0.1.1.1.12.67.24 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation? | FDA | A third-party certification body seeking accreditation must demonstrate that it has: (a) The resources necessary to fully implement its certification program, including: (1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively examine for compliance with applicable FDA food safety requirements of the FD&C Act and FDA regulations, conformance with applicable industry standards and practices, and issuance of valid and reliable certifications; and (2) Adequate financial resources for its operations; and (b) The competency and capacity to meet the applicable requirements of this subpart, if accredited. | ||||
| 21:21:1.0.1.1.1.12.67.25 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation? | FDA | A third-party certification body must demonstrate that it has: (a) Implemented written measures to protect against conflicts of interest between the third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) and clients seeking examinations or certification from, or audited or certified by, such third-party certification body; and (b) The capability to meet the conflict of interest requirements in § 1.657, if accredited. | ||||
| 21:21:1.0.1.1.1.12.67.26 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation? | FDA | A third-party certification body seeking accreditation must demonstrate that it has: (a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents involved in auditing and certification activities, including procedures to: (1) Identify deficiencies in its auditing and certification program or performance; and (2) Quickly execute corrective actions that effectively address any identified deficiencies; and (b) The capability to meet the quality assurance requirements of § 1.655, if accredited. | ||||
| 21:21:1.0.1.1.1.12.67.27 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.645 What records procedures must a third-party certification body have to qualify for accreditation? | FDA | A third-party certification body seeking accreditation must demonstrate that it: (a) Implemented written procedures to establish, control, and retain records (including documents and data) for a period of time necessary to meet its contractual and legal obligations and to provide an adequate basis for evaluating its program and performance; and (b) Is capable of meeting the reporting, notification, and records requirements of this subpart, if accredited. | ||||
| 21:21:1.0.1.1.1.12.68.28 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective? | FDA | (a) An accredited third-party certification body that uses audit agents to conduct food safety audits must ensure that each such audit agent meets the following requirements with respect to the scope of its accreditation under this subpart. If the accredited third-party certification body is an individual, that individual is also subject to the following requirements, as applicable: (1) Has relevant knowledge and experience that provides an adequate basis for the audit agent to evaluate compliance with applicable food safety requirements of the FD&C Act and FDA regulations and, for consultative audits, also includes conformance with applicable industry standards and practices; (2) Has been determined by the accredited third-party certification body, through observations of a representative sample of audits, to be competent to conduct food safety audits under this subpart relevant to the audits they will be assigned to perform; (3) Has completed annual food safety training that is relevant to activities conducted under this subpart; (4) Is in compliance with the conflict of interest requirements of § 1.657 and has no other conflicts of interest with the eligible entity to be audited that might impair the audit agent's objectivity; and (5) Agrees to notify its accredited third-party certification body immediately upon discovering, during a food safety audit, any condition that could cause or contribute to a serious risk to the public health. (b) In assigning an audit agent to conduct a food safety audit at a particular eligible entity, an accredited third-party certification body must determine that the audit agent is qualified to conduct such audit under the criteria established in paragraph (a) of this section and based on the scope and purpose of the audit and the type of facility, its process(es), and food. (c) An accredited third-party certification body cannot use an audit agent to conduct a regulatory audit at an eligible entity if such audit agent conducted a consultative audit or regulatory audit fo… | ||||
| 21:21:1.0.1.1.1.12.68.29 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity? | FDA | [80 FR 74650, Nov. 27, 2015, as amended at 86 FR 68817, Dec. 3, 2021] | (a) Audit planning. Before beginning to conduct a food safety audit under this subpart, an accredited third-party certification body must: (1) Require the eligible entity seeking a food safety audit to: (i) Identify the scope and purpose of the food safety audit, including the facility, process(es), or food to be audited; whether the food safety audit is to be conducted as a consultative or regulatory audit subject to the requirements of this subpart, and if a regulatory audit, the type(s) of certification(s) sought; and (ii) Provide a 30-day operating schedule for such facility that includes information relevant to the scope and purpose of the audit; and (2) Determine whether the requested audit is within its scope of accreditation. (b) Authority to audit. In arranging a food safety audit with an eligible entity under this subpart, an accredited third-party certification body must ensure it has authority, whether contractual or otherwise, to: (1) Conduct an unannounced audit to determine whether the facility, process(es), and food of the eligible entity (within the scope of the audit) comply with the applicable food safety requirements of the FD&C Act and FDA regulations and, for consultative audits, also includes conformance with applicable industry standards and practices; (2) Access any records and any area of the facility, process(es), and food of the eligible entity relevant to the scope and purpose of such audit; (3) When, for a regulatory audit, sampling and analysis is conducted, the accredited third-party certification body must use a laboratory that is accredited in accordance with ISO/IEC 17025:2017 to perform the analysis. (4) Notify FDA immediately if, at any time during a food safety audit, the accredited third-party certification body (or its audit agent, where applicable) discovers a condition that could cause or contribute to a serious risk to the public health and provide information required by § 1.656(c); (5) Prepare reports of audits conducted under this subpart as follows: (i… | |||
| 21:21:1.0.1.1.1.12.68.30 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.652 What must an accredited third-party certification body include in food safety audit reports? | FDA | (a) Consultative audits. An accredited third-party certification body must prepare a report of a consultative audit not later than 45 days after completing such audit and must provide a copy of such report to the eligible entity and must maintain such report under § 1.658, subject to FDA access in accordance with the requirements of section 414 of the FD&C Act. A consultative audit report must include: (1) The identity of the site or location where the consultative audit was conducted, including: (i) The name, address and the FDA Establishment Identifier of the facility subject to the consultative audit and a unique facility identifier, if designated by FDA; and (ii) Where applicable, the FDA registration number assigned to the facility under subpart H of this part; (2) The identity of the eligible entity, if different from the facility, including the name, address, the FDA Establishment Identifier and unique facility identifier, if designated by FDA, and, where applicable, registration number under subpart H of this part; (3) The name(s) and telephone number(s) of the person(s) responsible for compliance with the applicable food safety requirements of the FD&C Act and FDA regulations (4) The dates and scope of the consultative audit; (5) The process(es) and food(s) observed during such consultative audit; and (6) Any deficiencies observed that relate to or may influence a determination of compliance with the applicable food safety requirements of the FD&C Act and FDA regulations that require corrective action, the corrective action plan, and the date on which such corrective actions were completed. Such consultative audit report must be maintained as a record under § 1.658 and must be made available to FDA in accordance with section 414 of the FD&C Act. (b) Regulatory audits. An accredited third-party certification body must, no later than 45 days after completing a regulatory audit, prepare and submit electronically, in English, to FDA and to its recognized accreditation body (or, in the case of di… | ||||
| 21:21:1.0.1.1.1.12.68.31 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.653 What must an accredited third-party certification body do when issuing food or facility certifications? | FDA | (a) Basis for issuance of a food or facility certification. (1) Prior to issuing a food or facility certification to an eligible entity, an accredited third-party certification body (or, where applicable, an audit agent on its behalf) must complete a regulatory audit that meets the requirements of § 1.651 and any other activities that may be necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations. (2) If, as a result of an observation during a regulatory audit, an eligible entity must implement a corrective action plan to address a deficiency, an accredited third-party certification body may not issue a food or facility certification to such entity until after the accredited third-party certification body verifies that eligible entity has implemented the corrective action plan through methods that reliably verify the corrective action was taken and as a result the identified deficiency is unlikely to recur, except onsite verification is required for corrective actions required to address deficiencies that are the subject of a notification under § 1.656(c). (3) An accredited third-party certification body must consider each observation and the data and other information from a regulatory audit and other activities conducted under § 1.651 to determine whether the entity was in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations at the time of the audit and whether the eligible entity, given its food safety system and practices, would be likely to remain in compliance for the duration of any certification issued under this subpart. (4) A single regulatory audit may result in issuance of one or more food or facility certifications under this subpart, provided that the requirements of issuance are met as to each such certification. (5) Where an accredited third-party certification body uses an audit agent to conduct a regulatory audit of an eligible entity under this subpart, the accredited third-party certificatio… | ||||
| 21:21:1.0.1.1.1.12.68.32 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification? | FDA | If an accredited third-party certification body has reason to believe that an eligible entity to which it issued a food or facility certification may no longer be in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, the accredited third-party certification body must conduct any monitoring (including an onsite audit) of such eligible entity necessary to determine whether the entity is in compliance with such requirements. The accredited third-party certification body must immediately notify FDA, under § 1.656(d), if it withdraws or suspends a food or facility certification because it determines that the entity is no longer in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations. The accredited third-party certification body must maintain records of such monitoring under § 1.658. | ||||
| 21:21:1.0.1.1.1.12.68.33 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.655 How must an accredited third-party certification body monitor its own performance? | FDA | (a) An accredited third-party certification body must annually, upon FDA request made for cause, or as required under § 1.631(f)(1)(i), § 1.634(d)(1)(i), or § 1.635(c)(1)(i), conduct a self-assessment that includes evaluation of compliance with this subpart, including: (1) The performance of its officers, employees, or other agents involved in auditing and certification activities, including the performance of audit agents in examining facilities, process(es), and food using the applicable food safety requirements of the FD&C Act and FDA regulations; (2) The degree of consistency among its officers, employees, or other agents involved in auditing and certification activities, including evaluating whether its audit agents interpreted audit protocols in a consistent manner; (3) The compliance of the accredited third-party certification body and its officers, employees, and other agents involved in auditing and certification activities, with the conflict of interest requirements of § 1.657; (4) Actions taken in response to the results of any assessments conducted by FDA or, where applicable, the recognized accreditation body under § 1.621; and (5) As requested by FDA, any other aspects of its performance relevant to a determination of whether the accredited third-party certification body is in compliance with this subpart. (b) As a means to assess its performance, the accredited third-party certification body may evaluate the compliance of one or more of eligible entities to which a food or facility certification was issued under this subpart. (c) Based on the assessments and evaluations conducted under paragraphs (a) and (b) of this section, the accredited third-party certification body must: (1) Identify any deficiencies in complying with the requirements of this subpart; (2) Quickly implement corrective action(s) that effectively address the identified deficiencies; and (3) Under § 1.658, establish and maintain records of such corrective action(s). (d) The accredited third-party certification body must… | ||||
| 21:21:1.0.1.1.1.12.68.34 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.656 What reports and notifications must an accredited third-party certification body submit? | FDA | (a) Reporting results of regulatory audits. An accredited third-party certification body must submit a regulatory audit report, as described in § 1.652(b), electronically, in English, to FDA and to the recognized accreditation body that granted its accreditation (where applicable), no later than 45 days after completing such audit. (b) Reporting results of accredited third-party certification body self-assessments. An accredited third-party certification body must submit the report of its annual self-assessment required by § 1.655 electronically to its recognized accreditation body (or, in the case of direct accreditation, electronically and in English, to FDA), within 45 days of the anniversary date of its accreditation under this subpart. For an accredited third-party certification body subject to an FDA request for cause, or § 1.631(f)(1)(i), § 1.634(d)(1)(i), or § 1.635(c)(1)(i), the report of its self-assessment must be submitted to FDA electronically, in English, within 60 days of the FDA request, denial of renewal, revocation, or relinquishment of recognition of the accreditation body that granted its accreditation. Such report must include an up-to-date list of any audit agents it uses to conduct audits under this subpart. (c) Notification to FDA of a serious risk to public health. An accredited third-party certification body must immediately notify FDA electronically, in English, if during a regulatory or consultative audit, any of its audit agents or the accredited third-party certification body itself discovers a condition that could cause or contribute to a serious risk to the public health, providing the following information: (1) The name, physical address, and unique facility identifier, if designated by FDA, of the eligible entity subject to the audit, and, where applicable, the registration number under subpart H of this part; (2) The name, physical address, and unique facility identifier, if designated by FDA, of the facility where the condition was discovered (if different from that o… | ||||
| 21:21:1.0.1.1.1.12.68.35 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.657 How must an accredited third-party certification body protect against conflicts of interest? | FDA | (a) An accredited third-party certification body must implement a written program to protect against conflicts of interest between the accredited third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) and an eligible entity seeking a food safety audit or food or facility certification from, or audited or certified by, such accredited third-party certification body, including the following: (1) Ensuring that the accredited third-party certification body and its officers, employees, or other agents involved in auditing and certification activities do not own, operate, have a financial interest in, manage, or otherwise control an eligible entity to be certified, or any affiliate, parent, or subsidiary of the entity; (2) Ensuring that the accredited third-party certification body and, its officers, employees, or other agents involved in auditing and certification activities are not owned, managed, or controlled by any person that owns or operates an eligible entity to be certified; (3) Ensuring that an audit agent of the accredited third-party certification body does not own, operate, have a financial interest in, manage, or otherwise control an eligible entity or any affiliate, parent, or subsidiary of the entity that is subject to a consultative or regulatory audit by the audit agent; and (4) Prohibiting an accredited third-party certification body's officer, employee, or other agent involved in auditing and certification activities from accepting any money, gift, gratuity, or other item of value from the eligible entity to be audited or certified under this subpart. (5) The items specified in paragraph (a)(4) of this section do not include: (i) Money representing payment of fees for auditing and certification services and reimbursement of direct costs associated with an onsite audit by the third-party certification body; or (ii) Lunch of de minimis value provided during the course of an audit and on the premises where the audit is con… | ||||
| 21:21:1.0.1.1.1.12.68.36 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.658 What records requirements must a third-party certification body that has been accredited meet? | FDA | (a) A third-party certification body that has been accredited must maintain electronically for 4 years records created during its period of accreditation (including documents and data) that document compliance with this subpart, including: (1) Any audit report and other documents resulting from a consultative audit conducted under this subpart, including the audit agent's observations, correspondence with the eligible entity, verification of any corrective action(s) taken to address deficiencies identified during the audit; (2) Any request for a regulatory audit from an eligible entity; (3) Any audit report and other documents resulting from a regulatory audit conducted under this subpart, including the audit agent's observations, correspondence with the eligible entity, verification of any corrective action(s) taken to address deficiencies identified during the audit, and, when sampling and analysis is conducted, laboratory testing records and results from a laboratory that is accredited in accordance with § 1.651(b)(3), and documentation demonstrating such laboratory is accredited in accordance with § 1.651(b)(3); (4) Any notification submitted by an audit agent to the accredited third-party certification body in accordance with § 1.650(a)(5); (5) Any challenge to an adverse regulatory audit decision and the disposition of the challenge; (6) Any monitoring it conducted of an eligible entity to which food or facility certification was issued; (7) Its self-assessments and corrective actions taken to address any deficiencies identified during a self-assessment; and (8) Significant changes to its auditing or certification program that might affect compliance with this subpart. (b) An accredited third-party certification body must make the records of a consultative audit required by paragraph (a)(1) of this section available to FDA in accordance with section 414 of the FD&C Act. (c) An accredited third-party certification body must make the records required by paragraphs (a)(2) through (8) of this section … | ||||
| 21:21:1.0.1.1.1.12.69.37 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.660 Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application? | FDA | (a) Submission of accreditation or renewal application to a recognized accreditation body. A third-party certification body seeking accreditation must submit its request for accreditation or renewal of accreditation by a recognized accreditation body identified on the Web site described in § 1.690. (b) Notice of records custodian after denial of application for renewal of accreditation. An applicant whose renewal application was denied by a recognized accreditation body must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of accreditation or denial of the renewal application, of the name and contact information of the custodian who will maintain the records required by § 1.658(a) and make them available to FDA as required by § 1.658(b) and (c). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by § 1.658(a) will be located. (c) Effect of denial of an application for renewal of accreditation on food or facility certifications issued to eligible entities. A food or facility certification issued by an accredited third-party certification body prior to issuance of the denial of its renewal application l will remain in effect until the certification expires. If FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may refuse to consider the certification in determining the admissibility of the article of food for which the certification was offered or in determining the importer's eligibility for participation in VQIP. (d) Public notice of denial of an application for renewal of accreditation. FDA will provide notice on the Web site described in § 1.690 of the date of issuance of a denial of renewal of accreditation of a third-party certification body that had previous been accredited. | ||||
| 21:21:1.0.1.1.1.12.69.38 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.661 What is the duration of accreditation by a recognized accreditation body? | FDA | A recognized accreditation body may grant accreditation to a third-party certification body under this subpart for a period not to exceed 4 years. | ||||
| 21:21:1.0.1.1.1.12.69.39 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.662 How will FDA monitor accredited third-party certification bodies? | FDA | (a) FDA will periodically evaluate the performance of each accredited third-party certification body to determine whether the accredited third-party certification body continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the accredited third-party certification body that, if not corrected, would warrant withdrawal of its accreditation under § 1.664. FDA will evaluate each directly accredited third-party certification body annually. For a third-party certification body accredited by a recognized accreditation body, FDA will evaluate an accredited third-party certification body not later than 3 years after the date of accreditation for a 4-year term of accreditation, or by no later than the mid-term point for accreditation granted for less than 4 years. FDA may conduct additional performance assessments of an accredited third-party certification body at any time. (b) In evaluating the performance of an accredited third-party certification body under paragraph (a) of this section, FDA may review any one or more of the following: (1) Regulatory audit reports and food and facility certifications; (2) The accredited third-party certification body's self-assessments under § 1.655; (3) Reports of assessments by a recognized accreditation body under § 1.621; (4) Documents and other information relevant to a determination of the accredited third-party certification body's compliance with the applicable requirements of this subpart; and (5) Information obtained by FDA, including during inspections, audits, onsite observations, or investigations, of one or more eligible entities to which a food or facility certification was issued by such accredited third-party certification body. (c) FDA may conduct its evaluation of an accredited third-party certification body through a site visit to an accredited third-party certification body's headquarters (or other location that manages audit agents conducting food safety audits under this subpart, if diffe… | ||||
| 21:21:1.0.1.1.1.12.69.40 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits? | FDA | (a) An accredited third-party certification body may submit a request to FDA to waive the requirements of § 1.650(c) preventing an audit agent from conducting a regulatory audit of an eligible entity if the audit agent (or, in the case that the third-party certification body is an individual, the third-party certification body) has conducted a food safety audit of such entity during the previous 13 months. The accredited third-party certification body seeking a waiver or waiver extension must demonstrate there is insufficient access to audit agents and any third-party certification bodies that are comprised of an individual in the country or region where the eligible entity is located. (b) Requests for a waiver or waiver extension and all documents provided in support of the request must be submitted to FDA electronically, in English. The requestor must provide such translation and interpretation services as are needed by FDA to process the request. (c) The request must be signed by the requestor or by any individual authorized to act on behalf of the requestor for purposes of seeking such waiver or waiver extension. (d) FDA will review requests for waivers and waiver extensions on a first in, first out basis according to the date on which the completed submission is received; however, FDA may prioritize the review of specific requests to meet the needs of the program. FDA will evaluate any completed waiver request to determine whether the criteria for waiver have been met. (e) FDA will notify the requestor whether the request for a waiver or waiver extension is approved or denied. (f) If FDA approves the request, issuance of the waiver will state the duration of the waiver and list any limitations associated with it. If FDA denies the request, the issuance of a denial of a waiver request will state the basis for denial and will provide the address and procedures for requesting reconsideration of the request under § 1.691. (g) Unless FDA notifies a requestor that its waiver request has been approved, an acc… | ||||
| 21:21:1.0.1.1.1.12.69.41 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.664 When would FDA withdraw accreditation? | FDA | [80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016] | (a) Mandatory withdrawal. FDA will withdraw accreditation from a third-party certification body: (1) Except as provided in paragraph (b) of this section, if the food or facility certified under this subpart is linked to an outbreak of foodborne illness or chemical or physical hazard that has a reasonable probability of causing serious adverse health consequences or death in humans or animals; (2) Following an evaluation and finding by FDA that the third-party certification body no longer complies with the applicable requirements of this subpart; or (3) Following its refusal to allow FDA to access records under § 1.658 or to conduct an audit, assessment, or investigation necessary to ensure continued compliance with this subpart. (4) If payment of the third-party certification body's annual fee is not received within 90 days of the payment due date, as specified in § 1.725(c)(3). (b) Exception. FDA may waive mandatory withdrawal under paragraph (a)(1) of this section, if FDA: (1) Conducts an investigation of the material facts related to the outbreak of human or animal illness; (2) Reviews the relevant audit records and the actions taken by the accredited third-party certification body in support of its decision to certify; and (3) Determines that the accredited third-party certification body satisfied the requirements for issuance of certification under this subpart. (c) Discretionary withdrawal. FDA may withdraw accreditation, in whole or in part, from a third-party certification body when such third-party certification body is accredited by an accreditation body for which recognition is revoked under § 1.634, if FDA determines there is good cause for withdrawal, including: (1) Demonstrated bias or lack of objectivity when conducting activities under this subpart; or (2) Performance that calls into question the validity or reliability of its food safety audits or certifications. (d) Records access. FDA may request records of the accredited third-party certification body under § 1.658 and, whe… | |||
| 21:21:1.0.1.1.1.12.69.42 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation? | FDA | (a) Notice to FDA of intent to relinquish or not to renew accreditation. A third-party certification body must notify FDA electronically, in English, at least 60 days before voluntarily relinquishing accreditation or before allowing accreditation to expire without seeking renewal. The certification body must provide the name and contact information of the custodian who will maintain the records required under § 1.658(a) after the date of relinquishment or the date accreditation expires, as applicable, and make them available to FDA as required by § 1.658(b) and (c). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by § 1.658(a) will be located. (b) Notice to recognized accreditation body and eligible entities of intent to relinquish or not to renew accreditation. No later than 15 business days after notifying FDA under paragraph (a) of this section, the certification body must notify its recognized accreditation body and any eligible entity with current certifications that it intends to relinquish accreditation or to allow its accreditation to expire, specifying the date on which relinquishment or expiration will occur. The recognized accreditation body must establish and maintain records of such notification under § 1.625(a). (c) Effect of voluntary relinquishment or expiration of accreditation on food or facility certifications issued to eligible entities. A food or facility certification issued by a third-party certification body prior to relinquishment or expiration of its accreditation will remain in effect until the certification expires. If FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may refuse to consider the certification in determining the admissibility of the article of food for which the certification was offered or in determining the importer's eligibility for participation in VQIP. (d) Public notice of volunt… | ||||
| 21:21:1.0.1.1.1.12.69.43 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.666 How do I request reaccreditation? | FDA | (a) Application following withdrawal. FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation: (1) If, in the case of direct accreditation, FDA determines, based on evidence presented by the third-party certification body, that the third-party certification body satisfies the applicable requirements of this subpart and adequate grounds for withdrawal no longer exist; or (2) In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634: (i) If the third-party certification body becomes accredited by another recognized accreditation body or by FDA through direct accreditation no later than 1 year after withdrawal of accreditation, or the original date of the expiration of accreditation, whichever comes first; or (ii) Under such conditions as FDA may impose in withdrawing accreditation. (b) Application following voluntary relinquishment. A third-party certification body that previously relinquished its accreditation under § 1.665 may seek accreditation by submitting a new application for accreditation under § 1.660 or, where applicable, § 1.670. | ||||
| 21:21:1.0.1.1.1.12.70.44 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation? | FDA | (a) Eligibility. (1) FDA will accept applications from third-party certification bodies for direct accreditation or renewal of direct accreditation only if FDA determines that it has not identified and recognized an accreditation body to meet the requirements of section 808 of the FD&C Act within 2 years after establishing the accredited third-party audits and certification program. Such FDA determination may apply, as appropriate, to specific types of third-party certification bodies, types of expertise, or geographic location; or through identification by FDA of any requirements of section 808 of the FD&C Act not otherwise met by previously recognized accreditation bodies. FDA will only accept applications for direct accreditation and renewal applications that are within the scope of the determination. (2) FDA may revoke or modify a determination under paragraph (a)(1) of this section if FDA subsequently identifies and recognizes an accreditation body that affects such determination. (3) FDA will provide notice on the Web site described in § 1.690 of a determination under paragraph (a)(1) of this section and of a revocation or modification of the determination under paragraph (a)(1) of this section, as described in paragraph (a)(2) of this section. (b) Application for direct accreditation or renewal of direct accreditation. (1) A third-party certification body seeking direct accreditation or renewal of direct accreditation must submit an application to FDA, demonstrating that it is within the scope of the determination issued under paragraph (a)(1) of this section, and it meets the eligibility requirements of § 1.640. (2) Applications and all documents provided as part of the application process must be submitted electronically, in English. An applicant must provide such translation and interpretation services as are needed by FDA to process the application, including during an onsite audit of the applicant. (3) The application must be signed in the manner designated by FDA by an individual authorized … | ||||
| 21:21:1.0.1.1.1.12.70.45 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.671 How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application? | FDA | (a) Review of a direct accreditation or renewal application. FDA will examine a third-party certification body's direct accreditation or renewal application for completeness and notify the applicant of any deficiencies. FDA will review applications for direct accreditation and for renewal of direct accreditation on a first in, first out basis according to the date the completed submission is received; however, FDA may prioritize the review of specific applications to meet the needs of the program. (b) Evaluation of a direct accreditation or renewal application. FDA will evaluate any completed application to determine whether the applicant meets the requirements for direct accreditation under this subpart. If FDA does not reach a final decision on a renewal application before the expiration of the direct accreditation, FDA may extend the duration of such direct accreditation for a specified period of time or until the Agency reaches a final decision on the renewal application. (c) Notice of approval or denial. FDA will notify the applicant that its direct accreditation or renewal application has been approved through issuance of or denied. (d) Issuance of direct accreditation. If an application has been approved, the issuance of the direct accreditation that will list any limitations associated with the accreditation. (e) Issuance of denial of direct accreditation. If FDA issues a denial of direct accreditation or denial of a renewal application, the issuance of the denial of direct accreditation will state the basis for such denial and provide the procedures for requesting reconsideration of the application under § 1.691. (f) Notice of records custodian after denial of application for renewal of direct accreditation. An applicant whose renewal application was denied must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of a renewal application, of the name and contact information of the custodian who will maintain the records required by § 1.658(a… | ||||
| 21:21:1.0.1.1.1.12.70.46 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.672 What is the duration of direct accreditation? | FDA | FDA will grant direct accreditation of a third-party certification body for a period not to exceed 4 years. | ||||
| 21:21:1.0.1.1.1.12.71.47 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.680 How and when will FDA monitor eligible entities? | FDA | FDA may, at any time, conduct an onsite audit of an eligible entity that has received food or facility certification from an accredited third-party certification body under this subpart. Where FDA determines necessary or appropriate, the unannounced audit may be conducted with or without the accredited third-party certification body or the recognized accreditation body (where applicable) present. An FDA audit conducted under this section will be conducted on an unannounced basis and may be preceded by a request for a 30-day operating schedule. | ||||
| 21:21:1.0.1.1.1.12.71.48 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.681 How frequently must eligible entities be recertified? | FDA | An eligible entity seeking recertification of a food or facility certification under this subpart must apply for recertification prior to the expiration of its certification. For certifications used in meeting the requirements of section 801(q) or 806 of the FD&C Act, FDA may require an eligible entity to apply for recertification at any time FDA determines appropriate under such section. | ||||
| 21:21:1.0.1.1.1.12.72.49 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public? | FDA | FDA will place on its Web site a registry of recognized accreditation bodies and accredited third-party certification bodies, including the name, contact information, and scope and duration of recognition or accreditation. The registry may provide information on third-party certification bodies accredited by recognized accreditation bodies through links to the Web sites of such recognized accreditation bodies. FDA will also place on its Web site a list of accreditation bodies for which it has denied renewal of recognition, for which FDA has revoked recognition, and that have relinquished their recognition or have allowed their recognition to expire. FDA will also place in its Web site a list of certification bodies whose renewal of accreditation has been denied, for which FDA has withdrawn accreditation, and that have relinquished their accreditations or have allowed their accreditations to expire. FDA will place on its Web site determinations under § 1.670(a)(1) and modifications of such determinations under § 1.670(a)(2). | ||||
| 21:21:1.0.1.1.1.12.72.50 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request? | FDA | (a) An accreditation body may seek reconsideration of the denial of an application for recognition, renewal of recognition, or reinstatement of recognition no later than 10 business days after the date of the issuance of such denial. (b) A third-party certification body may seek reconsideration of the denial of an application for direct accreditation, renewal of direct accreditation, reaccreditation of directly accredited third-party certification body, a request for a waiver of the conflict of interest requirement in § 1.650(b), or a waiver extension no later than 10 business days after the date of the issuance of such denial. (c) A request to reconsider an application or waiver request under paragraph (a) or (b) of this section must be signed by the requestor or by an individual authorized to act on its behalf in submitting the request for reconsideration. The request must be submitted electronically in English and must comply with the procedures described in the notice. (d) After completing its review and evaluation of the request for reconsideration, FDA will notify the requestor through the issuance of the recognition, direct accreditation, or waiver upon reconsideration or through the issuance of a denial of the application or waiver request under paragraph (a) or (b) of this section upon reconsideration. | ||||
| 21:21:1.0.1.1.1.12.72.51 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration? | FDA | (a) No later than 10 business days after the date of issuance of a denial of an application or waiver request upon reconsideration under § 1.691, the requestor may seek internal agency review of such denial under § 10.75(c)(1) of this chapter. (b) The request for internal agency review under paragraph (a) of this section must be signed by the requestor or by an individual authorized to act on its behalf in submitting the request for internal review. The request must be submitted electronically in English to the address specified in the denial upon reconsideration and must comply with procedures it describes. (c) Under § 10.75(d) of this chapter, internal agency review of such denial must be based on the information in the administrative file, which will include any supporting information submitted under § 1.691(c). (d) After completing the review and evaluation of the administrative file, FDA will notify the requestor of its decision to overturn the denial and grant the application or waiver request through issuance of an application or waiver request upon reconsideration or to affirm the denial of the application or waiver request upon reconsideration through issuance of a denial of an application or waiver request upon reconsideration. (e) Issuance by FDA of a denial of an application or waiver request upon reconsideration constitutes final agency action under 5 U.S.C. 702. | ||||
| 21:21:1.0.1.1.1.12.72.52 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation? | FDA | (a) Request for hearing on revocation. No later than 10 business days after the date of issuance of a revocation of recognition of an accreditation body under § 1.634, an individual authorized to act on the accreditation body's behalf may submit a request for a regulatory hearing on the revocation under part 16 of this chapter. The issuance of revocation issued under § 1.634 will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter. (b) Request for hearing on withdrawal. No later than 10 business days after the date of issuance of a withdrawal of accreditation of a third-party certification body under § 1.664, an individual authorized to act on the third-party certification body's behalf may submit a request for a regulatory hearing on the withdrawal under part 16 of this chapter. The issuance of withdrawal under § 1.664 will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of opportunity of hearing under part 16 of this chapter. (c) Submission of request for regulatory hearing. The request for a regulatory hearing under paragraph (a) or (b) of this section must be submitted with a written appeal that responds to the basis for the FDA decision, as described in the issuance of revocation or withdrawal, as appropriate, and includes any supporting information upon which the requestor is relying. The request, appeal, and supporting information must be submitted in English to the address specified in the notice and must comply with the procedures it describes. (d) Effect of submission of request on FDA decision. The submission of a request for a regulatory hearing under paragraph (a) or (b) of this section will not operate to delay or stay the effect of a decision by FDA to revoke recognition of an accreditation body or to withdraw accreditation of a third-party certification body unless FDA determines that a delay or a stay is in the public inte… | ||||
| 21:21:1.0.1.1.1.12.72.53 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter? | FDA | Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 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 also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter. | ||||
| 21:21:1.0.1.1.1.12.72.54 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.695 Are the records obtained by FDA under this subpart subject to public disclosure? | FDA | Records obtained by FDA under this subpart are subject to the disclosure requirements under part 20 of this chapter. | ||||
| 21:21:1.0.1.1.1.12.73.55 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.700 Who is subject to a user fee under this subpart? | FDA | (a) Accreditation bodies submitting applications or renewal applications for recognition in the third-party certification program; (b) Recognized accreditation bodies participating in the third-party certification program; (c) Third-party certification bodies submitting applications or renewal applications for direct accreditation; and (d) Accredited third-party certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party certification program. | ||||
| 21:21:1.0.1.1.1.12.73.56 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.705 What user fees are established under this subpart? | FDA | (a) The following application fees: (1) Accreditation bodies applying for recognition are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for recognition of accreditation bodies. (2) Recognized accreditation bodies submitting renewal applications are subject to a renewal application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for recognition of accreditation bodies. (3) Third-party certification bodies applying for direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for direct accreditation. (4) Accredited third-party certification bodies applying for renewal of direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for direct accreditation. (b) The following annual fees: (1) Recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor performance of recognized accreditation bodies under § 1.633. (2) Third-party certification bodies directly accredited by FDA are subject to an annual fee for the estimated average cost of the work FDA performs to monitor directly accredited third-party certification bodies under § 1.662. (3) Third-party certification bodies accredited by recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor third-party certification bodies that are accredited by a recognized accreditation body under § 1.662. | ||||
| 21:21:1.0.1.1.1.12.73.57 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.710 How will FDA notify the public about the fee schedule? | FDA | FDA will notify the public of the fee schedule annually. The fee notice will be made publicly available prior to the beginning of the fiscal year for which the fees apply, except for the first fiscal year in which this regulation is effective. Each new fee schedule will be adjusted for inflation and improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year. | ||||
| 21:21:1.0.1.1.1.12.73.58 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.715 When must a user fee required by this subpart be submitted? | FDA | (a) Accreditation bodies applying for recognition and third-party certification bodies applying for direct accreditation must submit a fee concurrently with submitting an application or a renewal application. (b) Accreditation bodies and third-party certification bodies subject to an annual fee must submit payment within 30 days of receiving billing for the fee. | ||||
| 21:21:1.0.1.1.1.12.73.59 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.720 Are user fees under this subpart refundable? | FDA | User fees accompanying completed applications and annual fees under this subpart are not refundable. | ||||
| 21:21:1.0.1.1.1.12.73.60 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | § 1.725 What are the consequences of not paying a user fee under this subpart on time? | FDA | (a) An application for recognition or renewal of recognition will not be considered complete for the purposes of § 1.631(a) until the date that FDA receives the application fee. An application for direct accreditation or for renewal of direct accreditation will not be considered complete for the purposes of § 1.671(a) until FDA receives the application fee. (b) A recognized accreditation body that fails to submit its annual user fee within 30 days of the due date will have its recognition suspended. (1) FDA will notify the accreditation body electronically that its recognition is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690. (2) While an accreditation body's recognition is suspended, the accreditation body will not be able to accredit additional third-party certification bodies. The accreditation of third-party certification bodies that occurred prior to an accreditation body's suspension, as well as food or facility certifications issued by such third-party certification bodies, would remain in effect. (3) If payment is not received within 90 days of the payment due date, FDA will revoke the accreditation body's recognition under § 1.634(a)(4)(iii), and provide notice of such revocation in accordance with § 1.634. (c) An accredited third-party certification body that fails to submit its annual fee within 30 days of the due date will have its accreditation suspended. (1) FDA will notify the third-party certification body that its accreditation is suspended, electronically and in English. FDA will notify a recognized accreditation body, electronically and in English, if the accreditation of one if its third-party certification bodies is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690. (2) While a third-party certification body's accreditation is suspended, the third-party certification body will not be able to issue food or facility certifications. A food or facility certification issued by a third-party certificati… | ||||
| 21:21:1.0.1.1.1.14.74.1 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | O | Subpart O—Sanitary Transportation of Human and Animal Food | § 1.900 Who is subject to this subpart? | FDA | (a) Except for non-covered businesses as defined in § 1.904 and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstate commerce. The requirements of this subpart apply in addition to any other requirements of this chapter that are applicable to the transportation of food, e.g., in 21 CFR parts 1, 117, 118, 225, 507, and 589. (b) The requirements of this subpart do not apply to shippers, receivers, loaders, or carriers when they are engaged in transportation operations: (1) Of food that is transshipped through the United States to another country; or (2) Of food that is imported for future export, in accordance with section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that is neither consumed nor distributed in the United States; or (3) Of food when it is located in food facilities as defined in § 1.227 of this chapter, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ). | ||||
| 21:21:1.0.1.1.1.14.74.2 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | O | Subpart O—Sanitary Transportation of Human and Animal Food | § 1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act? | FDA | (a) The criteria and definitions of this subpart apply in determining whether food is adulterated within the meaning of section 402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations under conditions that are not in compliance with this subpart. (b) The failure by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations to comply with the requirements of this subpart is a prohibited act under section 301(hh) of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:1.0.1.1.1.14.74.3 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | O | Subpart O—Sanitary Transportation of Human and Animal Food | § 1.904 What definitions apply to this subpart? | FDA | The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply: Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. Animal food means food for animals other than man, and includes pet food, animal feed, and raw materials and ingredients. Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle. Carrier means a person who physically moves food by rail or motor vehicle in commerce within the United States. The term carrier does not include any person who transports food while operating as a parcel delivery service. Cross-contact means the unintentional incorporation of a food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act into food, except animal food. Farm has the meaning given in § 1.227 of this chapter. Food not completely enclosed by a container means any food that is placed into a container in such a manner that it is partially open to the surrounding environment. Examples of such containers include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag. This term does not include food transported in a bulk vehicle as defined in this subpart. Full-time equivalent employee is a term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. 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 business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours ( i.e., 40 hours x 52 weeks). If the result is… | ||||
| 21:21:1.0.1.1.1.14.75.4 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | O | Subpart O—Sanitary Transportation of Human and Animal Food | § 1.906 What requirements apply to vehicles and transportation equipment? | FDA | (a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe, i.e., adulterated within the meaning of section 402(a)(1), (2), and (4) of the Federal Food, Drug, and Cosmetic Act during transportation operations. (b) Vehicles and transportation equipment must be maintained in such a sanitary condition for their intended use as to prevent the food they transport from becoming unsafe during transportation operations. (c) Vehicles and transportation equipment used in transportation operations for food requiring temperature control for safety must be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the food from becoming unsafe during transportation operations. (d) Vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming unsafe during transportation operations. | ||||
| 21:21:1.0.1.1.1.14.76.5 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | O | Subpart O—Sanitary Transportation of Human and Animal Food | § 1.908 What requirements apply to transportation operations? | FDA | (a) General requirements. (1) Unless stated otherwise in this section, the requirements of this section apply to all shippers, carriers, loaders, and receivers engaged in transportation operations. A person may be subject to these requirements in multiple capacities, e.g., the shipper may also be the loader and the carrier, if the person also performs the functions of those respective persons as defined in this subpart. An entity subject to this subpart (shipper, loader, carrier, or receiver) may reassign, in a written agreement, its responsibilities under this subpart to another party subject to this subpart. The written agreement is subject to the records requirements of § 1.912(d). (2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subpart must be assigned to competent supervisory personnel. (3) All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe during transportation operations including: (i) Taking effective measures such as segregation, isolation, or the use of packaging to protect food from contamination by raw foods and nonfood items in the same load. (ii) Taking effective measures such as segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations. (iii) Taking effective measures to ensure that food that requires temperature control for safety is transported under adequate temperature control. (4) The type of food, e.g., animal feed, pet food, human food, and its production stage, e.g., raw material, ingredient or finished food, must be considered in determining the necessary conditions and controls for the transportation operation. (5) Shippers, receivers, loaders, and carriers, which are under the ownership or operational control of a single legal entity, as an … |
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