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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: 21CFR1.1330]



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

Records of Critical Tracking Events

Sec. 1.1330 What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?

(a) Except as specified in paragraph (c) of this section, for each traceability lot of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List you initially pack, you must maintain records containing the following information and linking this information to the traceability lot:

(1) The commodity and, if applicable, variety of the food received;

(2) The date you received the food;

(3) The quantity and unit of measure of the food received (e.g., 75 bins, 200 pounds);

(4) The location description for the farm where the food was harvested;

(5) For produce, the name of the field or other growing area from which the food was harvested (which must correspond to the name used by the grower), or other information identifying the harvest location at least as precisely as the field or other growing area name;

(6) For aquacultured food, the name of the container (e.g., pond, pool, tank, cage) from which the food was harvested (which must correspond to the container name used by the aquaculture farmer) or other information identifying the harvest location at least as precisely as the container name;

(7) The business name and phone number for the harvester of the food;

(8) The date of harvesting;

(9) The location description for where the food was cooled (if applicable);

(10) The date of cooling (if applicable);

(11) The traceability lot code you assigned;

(12) The product description of the packed food;

(13) The quantity and unit of measure of the packed food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);

(14) The location description for where you initially packed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;

(15) The date of initial packing; and

(16) The reference document type and reference document number.

(b) For each traceability lot of sprouts (except soil- or substrate-grown sprouts harvested without their roots) you initially pack, you must also maintain records containing the following information and linking this information to the traceability lot:

(1) The location description for the grower of seeds for sprouting and the date of seed harvesting, if either is available;

(2) The location description for the seed conditioner or processor, the associated seed lot code, and the date of conditioning or processing;

(3) The location description for the seed packinghouse (including any repackers), the date of packing (and of repacking, if applicable), and any associated seed lot code assigned by the seed packinghouse;

(4) The location description for the seed supplier, any seed lot code assigned by the seed supplier (including the master lot and sub-lot codes), and any new seed lot code assigned by the sprouter;

(5) A description of the seeds, including the seed type or taxonomic name, growing specifications, type of packaging, and (if applicable) antimicrobial treatment;

(6) The date of receipt of the seeds by the sprouter; and

(7) The reference document type and reference document number.

(c) For each traceability lot of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List you initially pack that you receive from a person to whom this subpart does not apply, you must maintain records containing the following information and linking this information to the traceability lot:

(1) The commodity and, if applicable, variety of the food received;

(2) The date you received the food;

(3) The quantity and unit of measure of the food received (e.g., 75 bins, 200 pounds);

(4) The location description for the person from whom you received the food;

(5) The traceability lot code you assigned;

(6) The product description of the packed food;

(7) The quantity and unit of measure of the packed food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);

(8) The location description for where you initially packed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;

(9) The date of initial packing; and

(10) The reference document type and reference document number.

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