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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR1.1315]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart S - Additional Traceability Records for Certain Foods

Traceability Plan

Sec. 1.1315 What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?

(a) If you are subject to the requirements in this subpart, you must establish and maintain a traceability plan containing the following information:

(1) A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records.

(2) A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold;

(3) A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable;

(4) A statement identifying a point of contact for questions regarding your traceability plan and records; and

(5) If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.

(i) Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.

(ii) For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.

(b) You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.

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