**Arthur Litman FedEx Trade Networks** Telephone 310-725-4750

# Vice President Transport & Brokerage Fax 310-725-4800 

*Regulatory Affairs* 2400 Marine Drive Email:
[allitman@fedex.com](mailto:lgbownjr@fedex.com)

Los Angeles, CA 90278

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# July 8, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

[Via e-mail: http://www.fda.gov/dockets/ecomments]{.underline}

RE: Comments of Proposed Notice of Rulemaking, Docket No. 02N-0277

Dear Sir or Madam:

FedEx Trade Networks Transportation and Brokerage, Inc (FTN)
wholeheartedly supports the goals of this proposal. We hope our comments
and recommendations will help make the final rule a more effective tool
in the defense against bioterrorism without placing unnecessary burdens
on trade.

328. **[Definitions of "Nontransporter" and "Transporter"]{.underline}**

The definitions of "nontransporter" and "transporter" in proposed 1.328
should be clarified to exclude parties not part of the physical chain of
custody of food. Specifically, the proposed 1.328 definition of a
"nontransporter" includes one who imports food. This definition could be
interpreted to include a customs broker whose only role is to file entry
on behalf of the actual importer. A customs broker could also be
considered a "transporter" because the customs broker's role as entry
filer is part of the transportation of food into the country. An entry
filer should be in neither category.

The stated purpose of the proposed rule is to establish a system of
record-keeping that identifies the chain of custody of food through each
transportation step. Customs brokers acting only as entry filers for an
importation should be considered neither "transporter" nor
"nontransporter" because they are not part of the physical chain of
custody. To do otherwise would be to artificially insert them into the
chain. An entry filer does not meet the definitions of "immediate
previous source" or "immediate subsequent recipient" as either a
"transporter" or "nontransporter" because they are neither source nor
recipient of shipments. To include customs brokers would insert a party
outside the chain of physical into a plan designed to trace physical
custody. It would not forward the goals of the proposed rule and would
result in duplicated and contradictory record-keeping.

For example, a shipper in Canada sends a shipment of food via truck to a
consignee in the United States. At the border, the truck stops for
Customs clearance. The customs broker files the entry and the shipment
is released. The truck continues on to deliver the shipment to the
consignee.

If the customs broker were considered a "nontransporter", they would be
required to list the trucker as both the "transporter immediate previous
source" and the "transporter immediate subsequent recipient. " with the
shipper and consignee as "nontransporter immediate previous source" and
"nontransporter immediate subsequent recipient" respectively. However,
the trucker, the shipper and consignee would not include the customs
broker in their records because the trucker retained custody throughout
the entry process.

The customs broker's records would not contain any new value-added
information not already maintained by those parties in the actual chain
of custody. The only difference in the customs broker's records would be
the artificial inclusion of the broker in the chain. That inclusion is
both unnecessary and a potential cause of confusion in a trace of
physical custody.

Further, FDA has requested suggestions for alternative record-keeping
arrangements that would allow for the complete and efficient
investigation of food- related emergencies. We contend that the
applicable record-keeping laws and regulations in 19 USC §1508 -- §1510
and 19 CFR Part 163 already require customs brokers to maintain records
that contain the majority of the information sought by FDA for a five
year period of time and to which FDA already has access. To maintain an
additional set of records for FDA would be duplicative and extremely
cost inefficient.

With the artificial inclusion in the definition of transporter or
nontransporter and the duplication in recordkeeping, we ask that customs
brokers be included in the final rule as a specifically exempted party
from the FDA record-keeping requirements.

**[1.361 Availability of Records]{.underline}**

Under proposed 1.361, records must be made available within 4 hours
Monday through Friday when the request is made between 8 AM and 6PM and
within 8 hours at other times. In most ports, the hours of operation of
the trade community mirror the hours of operation of regular commercial
operations of the Bureau of Customs and Border Protection (CBP). Outside
those hours of operation, FDA could encounter difficulty contacting
appropriate parties to request records. A method of communicating
requests for records should be established to ensure the appropriate
parties receive requests in a timely manner. We recommend each FDA
district office work with CBP and the local trade communities to develop
an emergency communication plan to handle requests made outside of the
regular operating hours of CBP commercial operations.

Sincerely,

Arthur L. Litman

Vice President, Regulatory Affairs