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Details of FDA Final Rule on Recordkeeping Under the Bioterrorism Act (Part III)

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 certain persons (unless excluded) who manufacture, import, process, pack, transport, distribute, receive, or hold foods 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 III of a multi-part series of summaries of this final rule. Part III focuses on 21 CFR 1.352, which describes the various options that transporters have for establishing and maintaining the required records. 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 "transporter." See future issues of ITT for additional summaries, including one on recordkeeping for nontransporters.)

FDA Final Rule Provides Five Recordkeeping Options for Transporters

The FDA states that transporters must establish and maintain the following records for each food they transport in the U.S. This requirement may be fulfilled by either:

Option 1 - Establishing and maintaining certain records. Under new 21 CFR 1.352(a), transporters may establish and maintain the following records:

Names of the transporter's immediate previous source and transporter's immediate subsequent recipient;

Origin and destination points;

Date shipment received and date released;

Number of packages;

Description of freight;

Route of movement during the time the transporter transported the food; and

Transfer point(s) through which shipment moved; or

Option 2 - Establishing and maintaining records required by FMCSA (roadway Interstate Transporters). New 21 CFR 1.352(b) states that transporters may establish and maintain records containing the following information currently required of roadway interstate transporters by the Department of Transportation's Federal Motor Carrier Safety Administration (FMCSA) under 49 CFR 373.101 and 373.103 as of December 9, 2004:

Names of consignor and consignee;

Origin and destination points;

Date of shipment;

Number of packages;

Description of freight;

Route of movement and name of each carrier participating in the transportation; and

Transfer points through which shipment moved; or

Option 3 - Establishing and maintaining records required by Surface Transportation Board (rail and water interstate transporters). New 21 CFR 1.352(c) states that transporters may establish and maintain records containing the following information currently required by the Department of Transportation's Surface Transportation Board of rail and water interstate transporters under 49 CFR 1035.1 and 1035.2 as of December 9, 2004:

Date received;

Received from;

Consigned to;

Destination;

State of;

County of;

Route;

Delivering carrier;

Car initial;

Car no;

Trailer initials/number;

Container initials/number;

No. packages; and

Description of articles; or

Option 4 - Establishing and maintaining records required by Warsaw Convention (international air carriers). New 21 CFR 1.352(d) states that transporters have the option of establishing and maintaining records containing the following information currently required by the Warsaw Convention of international air transporters on air waybills:

Shipper's name and address;

Consignee's name and address;

Customs reference/status;

Airport of departure and destination;

First carrier; and

Description of goods; or

Option 5 - Recordkeeping agreements with certain nontransporters. New 21 CFR 1.352(e) states that a transporter may enter into an agreement with the nontransporter immediate previous source located in the U.S. and/or the nontransporter immediate subsequent recipient located in the U.S. to establish, maintain, or establish and maintain, the information in 21 CFR 1.352(a), (b), (c), or (d). The agreement must contain the following elements:

Effective date;

Printed names and signatures of authorized officials;

Description of the records to be established and/or maintained;

Provision for the records to be maintained in compliance with 21 CFR 1.360, if the agreement provides for maintenance of records;

Provision for the records to be available to FDA as required by 21 CFR 1.361, if the agreement provides for maintenance of records;

Acknowledgement that the nontransporter assumes legal responsibility under 21 CFR 1.363 for establishing and/or maintaining the records as required by this subpart; and

Provision that if the agreement is terminated in writing by either party, responsibility for compliance with the applicable establishment, maintenance, and access provisions of Subpart J reverts to the transporter as of the date of termination.

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

FDA Contact - Nega Beru (301) 436-1400

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