[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Rules and Regulations]
[Pages 65815-65816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]
RIN 0910-AI44


Requirements for Additional Traceability Records for Certain 
Foods; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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, [email protected].

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 Sec.  1.1350(b), the entity 
who transforms the whole apples into sliced apples would be required to 
keep the initial packing records specified under Sec.  1.1330(a) or 
(c), and would not be required to keep transformation records under 
Sec.  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 Sec.  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 Sec.  1.1305(d)(4) is revised to contain new 
parenthetical language. We have added this parenthetical language to 
clarify that the partial exemption in Sec.  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 Sec.  1.1345 for their receipt 
of the food that they change. This parenthetical aligns with Sec.  
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

0
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.


0
2. In Sec.  1.1305, revise paragraph (d)(4) to read as follows:


Sec.  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 Sec.  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

[[Page 65816]]

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.
[FR Doc. 2023-20746 Filed 9-25-23; 8:45 am]
BILLING CODE 4164-01-P