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FDA's Final Rule on Recordkeeping Under the Bioterrorism Act (Part IV)

The Food and Drug Administration (FDA) has issued a final rule that adds a new Subpart J to 21 CFR Part 1 (Subpart J) and a new paragraph (f) to 21 CFR 11.1 to, among other things, require the establishment and maintenance of records by persons (unless excluded) who manufacture, import, process, pack, transport, distribute, receive, or hold food in the U.S.

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According to the FDA, such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food.

This is Part IV of a multi-part series of summaries of this final rule. Part IV focuses on 21 CFR 1.337 and 1.345 which describe requirements for nontransporters to establish and maintain records to identify both the nontransporter and transporter immediate previous sources of food as well as the nontransporter and transporter immediate subsequent recipients of food. (See ITT's Online Archives or 01/06/05 news, 05010615, for Part II of BP's summary of this final rule, which includes a definition of "nontransporter." See future issues of ITT for additional summaries.)

Nontransporter Must Identify Immediate Previous Sources of Food

Under new 21 CFR 1.337, nontransporters must establish and maintain the following records for all food they receive:

The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the nontransporter immediate previous source, whether domestic or foreign;

An adequate description of the type of food received, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

The date the food was received;

For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists);

The quantity and how the food is packaged (e.g., 6 count bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) tank); and

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate previous source (the transporter who transported the food to you).

Nontransporter Must Identify Immediate Subsequent Recipients of Food

New 21 CFR 1.345 provides that nontransporters must also establish and maintain the following records for food they release:

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the nontransporter immediate subsequent recipient, whether domestic or foreign;

An adequate description of the type of food released, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

The date the food was released;

For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists);

The quantity and how the food is packaged (e.g., 6 count bunches, 25 lb carton, 12 oz bottle, 100 gal tank); and

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate subsequent recipient (the transporter who transported the food from the nontransporter).

The final rule also requires that nontransporters' records include information reasonably available to them to identify the specific source of each ingredient used to make every lot of finished product.

(See ITT's Online Archives or 12/08/04, 01/05/05, 01/06/05, and 01/11/05 news 04120810, 05010510, 05010615, and 05011125, for BP summary announcing the publication of this final rule, as well as Parts I-III of BP's summary of the final rule's regulations.)

FDA Contact - Nega Beru (301) 436-1400

FDA Final Rule (D/N 2002N-0277, FR Pub 12/09/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26929.pdf