2023-20746. Requirements for Additional Traceability Records for Certain Foods; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is correcting the final rule on requirements for additional traceability records for certain foods that published in the Federal Register of November 21, 2022. The final rule published with some editorial and inadvertent errors. This document corrects those errors.

DATES:

Effective September 26, 2023.

FOR FURTHER INFORMATION CONTACT:

Katherine Vierk, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2122, [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of November 21, 2022 (87 FR 70910), FDA published the final rule “Requirements for Additional Traceability Records for Certain Foods” with some editorial and inadvertent errors in the preamble to the final rule and in the provisions added to the Code of Federal Regulations. We are taking this action to correct those errors and to improve the accuracy of the regulatory text.

1. On page 70991, in Response 275, “As noted in Response 450, we have deleted as unnecessary the use of `(s)' (indicating pluralization of terms as applicable) from all provisions in which we had proposed to include it (except with respect to the definition of `retail food establishment,' where we have retained it so that the definition is the same as in other FDA regulations)” is corrected to read “As noted in Response 396, we have deleted as unnecessary the use of `(s)' (indicating pluralization of terms as applicable) from all provisions in which we had proposed to include it (except with respect to the definition of `retail food establishment,' where we have retained it so that the definition is the same as in other FDA regulations).”

2. On page 71001, in the second paragraph of Response 321, “KDEs for a CTE could be `linked' in different ways, including by being listed together in single row of an electronic sortable spreadsheet, stored together as a record in a database, shared to a subsequent recipient as an electronic message, or printed on the same commercial document ( e.g., BOL).” is corrected to read “KDEs for a CTE could be `linked' in different ways, including by being listed together in a single row of an electronic sortable spreadsheet, stored together as a record in a database, shared to a subsequent recipient as an electronic message, or printed on the same commercial document ( e.g., BOL).”

3. On page 71033, in the second paragraph of Response 429, the following sentence is deleted: “If the apples are sliced before initial packing, then, as specified under § 1.1350(b), the entity who transforms the whole apples into sliced apples would be required to keep the initial packing records specified under § 1.1330(a) or (c), and would not be required to keep transformation records under § 1.1350(a) (see Response 444 (434 (creation CTE requirements would not apply to the creation of an FTL food solely for the purpose of being transformed into another food in continuous processing)).” We are deleting this sentence because § 1.1350(b) does not apply to this situation. Section 1.1350(b) applies when a traceability lot is produced through “transformation of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List that was not initially packed prior to your transformation of the food” (emphasis added). The situation described in the second paragraph of Response 429 relates to the transformation of a raw agricultural commodity that is not on the Food Traceability List (whole apples) into a food (sliced apples) that is on the Food Traceability List. Once this sentence is deleted, the remainder of the paragraph correctly explains which provisions apply to this situation.

4. The exemption in § 1.1305(d)(4) is revised to contain new parenthetical language. We have added this parenthetical language to clarify that the partial exemption in § 1.1305(d)(6), when applicable, exempts a person who changes food such that it is no longer on the Food Traceability List from the requirement to maintain records containing the information specified in § 1.1345 for their receipt of the food that they change. This parenthetical aligns with § 1.1305(d)(3)(i).

List of Subjects in 21 CFR Part 1

• Cosmetics
• Drugs
• Exports
• Food labeling
• Imports
• Labeling
• Reporting and recordkeeping requirements

PART 1—GENERAL ENFORCEMENT REGULATIONS

1. The authority citation for part 1 continues to read as follows:

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc–1, 360ccc–2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

2. In § 1.1305, revise paragraph (d)(4) to read as follows:

§ 1.1305

What foods and persons are exempt from this subpart?

* * * * *

(d) * * *

(4) Food that you change such that the food is no longer on the Food Traceability List, provided that you maintain records containing the information specified in § 1.1345 for your receipt of the food you change (unless you have entered into a written agreement concerning your changing of the food such that the food is no longer on the Food Traceability List in accordance with paragraph (d)(6) of this section);

* * * * *

Dated: September 20, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.