Title 21—Food and Drugs--Volume 1
PART 1—GENERAL ENFORCEMENT REGULATIONS
§ 1.1380   What process applies to a petition requesting modified requirements or an exemption?
(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting modified requirements or an exemption. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.
(b) Under § 10.30(h)(3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition, including information and views from persons who could be affected by the modified requirements or exemption if we granted the petition.
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:
(1) If we grant the petition either in whole or in part, we will publish a notice in the Federal Register setting forth any modified requirements or exemptions and the reasons for them.
(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.
(d) We will make readily accessible to the public, and periodically update, a list of petitions requesting modified requirements or exemptions, including the status of each petition (for example, pending, granted, or denied).
§ 1.1385   What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
(a) If FDA, on our own initiative, determines that adopting modified requirements or granting an exemption from the requirements for a food or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed modified requirements or exemption and the reasons for the proposal. The notice will establish a public docket so that interested persons may submit written comments on the proposal.
(b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are adopting modified requirements or granting an exemption, and the reasons for our decision.
§ 1.1390   When will modified requirements that we adopt or an exemption that we grant become effective?
Any modified requirements that FDA adopts or exemption that we grant will become effective on the date that notice of the modified requirements or exemption is published in the Federal Register , unless otherwise stated in the notice.
§ 1.1395   Under what circumstances may FDA revise or revoke modified requirements or an exemption?
FDA may revise or revoke modified requirements or an exemption if we determine that such revision or revocation is necessary to protect the public health.
§ 1.1400   What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?
(a) If FDA tentatively determines that we should revise or revoke modified requirements or an exemption, we will provide the following notifications:
(1) We will notify the person that originally requested the modified requirements or exemption (if we adopted modified requirements or granted an exemption in response to a petition) in writing at the address identified in the petition; and
(2) We will publish a notice in the Federal Register of our tentative determination that the modified requirements or exemption should be revised or revoked and the reasons for our tentative decision. The notice will establish a public docket so that interested persons may submit written comments on our tentative determination.
(b) After considering any comments timely submitted, we will publish a notice in the Federal Register of our decision whether to revise or revoke the modified requirements or exemption and the reasons for the decision. If we do revise or revoke the modified requirements or exemption, the effective date of the decision will be 1 year after the date of publication of the notice, unless otherwise stated in the notice.
§ 1.1405   Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
FDA will waive one or more of the requirements of this subpart when we determine that:
(a) Application of the requirements would result in an economic hardship for an individual entity or a type of entity, due to the unique circumstances of the individual entity or type of entity;
(b) The waiver will not significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; and
(c) The waiver will not otherwise be contrary to the public interest.
§ 1.1410   When will FDA consider whether to waive a requirement of this subpart?
FDA will consider whether to waive a requirement of this subpart on our own initiative or in response to the following:
(a) A written request for a waiver for an individual entity; or
(b) A citizen petition requesting a waiver for a type of entity submitted under § 10.30 of this chapter by any person subject to the requirements of this subpart.
§ 1.1415   How may I request a waiver for an individual entity?
You may request a waiver of one or more requirements of this subpart for an individual entity by submitting a written request to the Food and Drug Administration as described at www.fda.gov. The request for a waiver must include the following:
(a) The name, address, and point of contact of the individual entity to which the waiver would apply;
(b) The requirements of this subpart to which the waiver would apply;
(c) Information demonstrating why application of the requirements requested to be waived would result in an economic hardship for the entity, including information about the unique circumstances faced by the entity that result in unusual economic hardship from the application of these requirements;
(d) Information demonstrating why the waiver will not significantly impair FDA's ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; and
(e) Information demonstrating why the waiver would not otherwise be contrary to the public interest.
§ 1.1420   What process applies to a request for a waiver for an individual entity?
(a) After considering the information submitted in a request for a waiver for an individual entity, we will respond in writing to the person that submitted the waiver request stating whether we are granting the waiver (in whole or in part) and the reasons for the decision.
(b) Any waiver for an individual entity that FDA grants will become effective on the date we issue our response to the waiver request, unless otherwise stated in the response.
§ 1.1425   What must be included in a petition requesting a waiver for a type of entity?
In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting a waiver for a type of entity must:
(a) Specify the type of entity to which the waiver would apply and the requirements of this subpart to which the waiver would apply;
(b) Present information demonstrating why application of the requirements requested to be waived would result in an economic hardship for the type of entity, including information about the unique circumstances faced by the type of entity that result in unusual economic hardship from the application of these requirements;
(c) Present information demonstrating why the waiver will not significantly impair FDA's ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; and
(d) Present information demonstrating why the waiver would not otherwise be contrary to the public interest.
§ 1.1430   What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
FDA will presume that information submitted in a petition requesting a waiver for a type of entity, as well as information in comments submitted on such a petition, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with the petition.
§ 1.1435   What process applies to a petition requesting a waiver for a type of entity?
(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting a waiver. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.
(b) Under § 10.30(h)(3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition requesting a waiver for a type of entity, including information and views from persons who could be affected by the waiver if we granted the petition.
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:
(1) If we grant the petition either in whole or in part, we will publish a notice in the Federal Register setting forth any requirements we have waived and the reasons for the waiver.
(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.
(d) We will make readily accessible to the public, and periodically update, a list of petitions requesting waivers for types of entities, including the status of each petition (for example, pending, granted, or denied).
§ 1.1440   What process will FDA follow when waiving a requirement of this subpart on our own initiative?
(a) If FDA, on our own initiative, determines that a waiver of one or more requirements for an individual entity or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed waiver and the reasons for such waiver. The notice will establish a public docket so that interested persons may submit written comments on the proposal.
(b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are granting the waiver (in whole or in part) and the reasons for our decision.
(c) Any waiver for a type of entity that FDA grants will become effective on the date that notice of the waiver is published in the Federal Register, unless otherwise stated in the notice.
§ 1.1445   Under what circumstances may FDA modify or revoke a waiver?
FDA may modify or revoke a waiver if we determine that:
(a) Compliance with the waived requirements would no longer impose a unique economic hardship on the individual entity or type of entity to which the waiver applies;
(b) The waiver could significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; or
(c) The waiver is otherwise contrary to the public interest.
§ 1.1450   What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?
(a) Waiver for an individual entity. (1) If FDA tentatively determines that we should modify or revoke a waiver for an individual entity, we will notify the person that had received the waiver in writing of our tentative determination that the waiver should be modified or revoked. The notice will provide the waiver recipient 60 days in which to submit information stating why the waiver should not be modified or revoked.
(2) Upon consideration of any information submitted by the waiver recipient, we will respond in writing stating our decision whether to modify or revoke the waiver and the reasons for the decision. If we modify or revoke the waiver, the effective date of the decision will be 1 year after the date of our response to the waiver recipient, unless otherwise stated in the response.
(b) Waiver for a type of entity. (1) If FDA tentatively determines that we should modify or revoke a waiver for a type of entity, we will provide the following notifications:
(i) We will notify the person that originally requested the waiver (if we granted the waiver in response to a petition) in writing at the address identified in the petition.
(ii) We will publish a notice in the Federal Register of our tentative determination that the waiver should be modified or revoked and the reasons for our tentative decision. The notice will establish a public docket so that interested persons may submit written comments on our tentative determination.
(2) After considering any comments timely submitted, we will publish a notice in the Federal Register of our decision whether to modify or revoke the waiver and the reasons for the decision. If we do modify or revoke the waiver, the effective date of the decision will be 1 year after the date of publication of the notice, unless otherwise stated in the notice.
§ 1.1455   How must records required by this subpart be maintained and made available?
(a) General requirements for records. (1) You must keep records as original paper or electronic records or true copies (such as photocopies, pictures, scanned copies, or other accurate reproductions of the original records). Electronic records may include valid, working electronic links to the information required to be maintained under this subpart.
(2) All records must be legible and stored to prevent deterioration or loss.
(b) Establishment and maintenance of records by another entity. You may have another entity establish and maintain records required under this subpart on your behalf, but you are responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review.
(c) Record availability. (1) You must make all records required under this subpart available to an authorized FDA representative, upon request, within 24 hours (or within some reasonable time to which FDA has agreed) after the request, along with any information needed to understand these records, such as internal or external coding systems, glossaries, abbreviations, and a description of how the records you provide correspond to the information required under this subpart.
(2) Offsite storage of records 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) When necessary to help FDA prevent or mitigate a foodborne illness outbreak, or to assist in the implementation of a recall, or to otherwise address a threat to the public health, including but not limited to situations where FDA has a reasonable belief that an article of food (and any other article of food that FDA reasonably believes is likely to be affected in a similar manner) presents a threat of serious adverse health consequences or death to humans or animals as a result of the food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act, you must make available, within 24 hours (or within some reasonable time to which FDA has agreed) of a request made in-person or remotely ( e.g., by phone) by an authorized FDA representative, the information you are required to maintain under this subpart, for the foods and date ranges or traceability lot codes specified in the request.
(i) If FDA's request for the information specified in paragraph (c)(3) of this section is made by phone, we will also provide the request to you in writing upon your request; however, you must provide the requested information within 24 hours (or within some reasonable time to which FDA has agreed) of the phone request.
(ii) Except as specified in paragraph (c)(3)(iii) and (iv) of this section, when the information requested by FDA under paragraph (c)(3) of this section is information you are required to maintain under §§ 1.1325 through 1.1350, you must provide such information in an electronic sortable spreadsheet, along with any other information needed to understand the information in the spreadsheet.
(iii) You may provide the information requested by FDA under paragraph (c)(3) of this section in a form other than an electronic sortable spreadsheet if you are:
(A) A farm whose average annual sum of the monetary value of their sales of raw agricultural commodities and the market value of raw agricultural commodities they manufacture, process, pack, or hold without sale ( e.g., held for a fee) during the previous 3-year period is no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment;
(B) A retail food establishment or restaurant with an average annual monetary value of food sold or provided during the previous 3-year period of no more than $1 million (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment; or
(C) A person (other than a farm, retail food establishment, or restaurant) whose average annual sum of the monetary value of their sales of food and the market value of food they manufacture, process, pack, or hold without sale ( e.g., held for a fee) during the previous 3-year period is no more than $1 million (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
(iv) FDA will withdraw a request for an electronic sortable spreadsheet under paragraph (c)(3)(ii) of this section, as appropriate, to accommodate a religious belief of a person asked to provide such a spreadsheet.
(4) Upon FDA request, you must provide within a reasonable time an English translation of records required under this subpart maintained in a language other than English.
(d) Record retention. Except as specified otherwise in this subpart, you must maintain records containing the information required by this subpart for 2 years from the date you created or obtained the records.
(e) Electronic records. 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, if not otherwise exempt.
(f) Use of existing records. You do not need to duplicate existing records you have ( e.g., records that you keep in the ordinary course of business or that you maintain to comply with other Federal, State, Tribal, territorial, or local regulations) if they contain the information required by this subpart. You may supplement any such existing records as necessary to include all of the information required by this subpart.
(g) Use of multiple sets of records. You do not have to keep all of the information required by this subpart in a single set of records. However, your traceability plan must indicate the format and location of the records you are required to keep under this subpart, in accordance with § 1.1315(a)(1).
(h) Public disclosure. Records obtained by FDA in accordance with this subpart are subject to the disclosure requirements under part 20 of this chapter.
§ 1.1460   What consequences could result from failing to comply with the requirements of this subpart?
(a) Prohibited act. The violation of any recordkeeping requirement under section 204 of the FDA Food Safety Modernization Act, including the violation of any requirement of this subpart, is prohibited under section 301(e) of the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm.
(b) Refusal of admission. An article of food is subject to refusal of admission under section 801(a)(4) of the Federal Food, Drug, and Cosmetic Act if it appears that the recordkeeping requirements under section 204 of the FDA Food Safety Modernization Act (other than the requirements under subsection (f) of that section), including the requirements of this subpart, have not been complied with regarding such article.
§ 1.1465   How will FDA update the Food Traceability List?
(a) When FDA tentatively concludes, in accordance with section 204(d)(2) of the FDA Food Safety Modernization Act, that it is appropriate to revise the Food Traceability List, we will publish a notice in the Federal Register stating the proposed changes to the list and the reasons for these changes and requesting information and views on the proposed changes.
(b) After considering any information and views submitted on the proposed changes to the Food Traceability List, FDA will publish a notice in the Federal Register stating whether we are making any changes to the list and the reasons for the decision. If FDA revises the list, we will also publish the revised list on our website.
(c) When FDA updates the Food Traceability List in accordance with this section, any deletions from the list will become effective immediately. Any additions to the list will become effective 2 years after the date of publication of the Federal Register notice announcing the revised list, unless otherwise stated in the notice.