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FDA Appears to Compromise on Cross-Docking

WASHINGTON, D.C. - The U.S. Food and Drug Administration appears to be heeding the industry's criticism of rules which potentially required registration of cross-docking and courier terminals as food ...


FDA QUANDARY: Do cross-docking terminals count as food facilities?
FDA QUANDARY: Do cross-docking terminals count as food facilities?

WASHINGTON, D.C. – The U.S. Food and Drug Administration appears to be heeding the industry’s criticism of rules which potentially required registration of cross-docking and courier terminals as food facilities.

Since receiving comments from the American Trucking Associations and the Canadian Trucking Alliance in December, the FDA appears to have made a distinction between cross-docking, sorting and courier facilities and facilities which must be registered as food facilities under the rules implemented Dec. 12, 2003.

The following is an excerpt from a guidance document published by the FDA Jan. 12, 2004:

“Q: (Added December 30, 2003) Post offices and similar facilities owned or operated by express couriers may have packages containing food on their premises as part of the shipment process. Are these types of establishments required to be registered with FDA as food facilities?

A: No. For purposes of the registration Interim Final Rule, post offices and express courier facilities are not required to be registered with FDA as food facilities.

The activities of both postal services and express courier services are focused on the transport of goods; their facilities generally serve only as a point of transfer of packages and other freight, including packages containing food.

Thus, it is appropriate to view both types of facilities as part of the transportation process.

The definition of “facility” in the Interim Final Rule (21 CFR 1.226(b)(2)) does not include transportation vehicles “if they hold food only in the usual course of business as carriers.”

Although the registration Interim Final Rule does not define “transportation vehicles,” the proposed rule on the establishment and maintenance of records (68 FR 25188 at 25238; May 9, 2003) defines “transporter” as “a person who has possession, custody, or control of an article of food – for the sole purpose of transporting the food.”

FDA believes that it is appropriate to apply this same rationale to exclude from registration facilities that house food only because they are part of the process of transporting it from one location to another.

This analysis is also consistent with the definition of “facility” in 21 CFR 1.227(b)(2).

Thus, for the purpose of the registration Interim Final Rule, post offices and express courier facilities operating in a manner comparable to post offices that are part of the transportation network and have possession, custody, or control of food for the sole purpose of transporting it are not required to be registered with FDA.

Q: (Added December 30, 2003) Truck terminals and freight forwarders may have food on their premises as part of the shipment process.

Are these types of establishments required to be registered with FDA as food facilities?

A: No. Truck terminals and other stationary facilities that serve merely to assist transportation vehicles in the process of transporting food are not required to be registered with FDA.

The analysis for post offices and similar facilities is also applicable here.

Thus, for the purpose of the registration Interim Final Rule, truck terminals and freight forwarders that are part of the transportation network and have possession, custody, or control of food for the sole purpose of facilitating its transport are not required to be registered with FDA.

FDA acknowledges that this response is not completely consistent with certain prior guidance (Response to Comment 36; 68 Fed. Reg. 58894 at 58904; October 10, 2003).

The agency has further considered this issue, as well as related ones, resulting in a revision of the earlier guidance.”

To view a copy of the new guidance document issued by the FDA Jan. 12, visit trucknews.com and click on the Border Legislation Proposals icon, then click on “FDA guidance document – Jan. 12,2004.”

You can also view the document at: http://www.cfsan.fda.gov/~dms/ffregui2.html


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