From: lgbownjr@fedex.com
Sent: Tuesday, July 08, 2003 10:58 AM
To: fdadockets@oc.fda.gov
Subject: Comment for Docket # 02N-0277

NOTICE:  this also is being submitted on the website in two separate
documents because of the attachment restrictions.

                           NBCBA Comments to FDA
                                 7/08/2003

                                    2
NORTHERN BORDER CUSTOMS BROKERS ASSOCIATION, INC.

                                PRESIDENT
TREASURER                                              SECRETARY
       Leman G. (Chip) Bown, Jr.                        Mary Ann Comstock
Mary Anne Webb
                               FedEx Trade Networks         W.Y. Moberly,
Inc. W.F. Whelan Company
                                128 Dearborn Street     P.O. Box 164
6850 Middlebelt Road
                                Buffalo, NY 14207       Sweetgrass, MT
59484  Romulus, MI 48174
                                Tel:   716-871-3240     Tel:   406-335-2211
Tel:   734-721-6410
                                Fax:  716-871-3255      Fax:  406-335-2630
Fax:  734-721-2835
       E-Mail:  lgbownjr@fedex.com                      E-Mail:
WYMobrly@northerntel.net        E-Mail:  mawebb@wfwhelan.com

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.oc.fda.gov

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

Dear Sir or Madam:

The Northern Border Customs Brokers Association (NBCBA) wishes to be on
record as supporting the efforts of our Congress and the U.S. Food and Drug
Administration (FDA) to protect the food supply of the United States.  We
appreciate the importance of FDA's responsibility for protecting the U.S.
population from imports of food that may be adulterated and /or pose other
health risks.

We offer the following comments in response to the Notice of Proposed
Rulemaking (NPRM) entitled "Establishment and Maintenance of Records Under
the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002" (Docket 02N-0277), published in the Federal Register on May 9,
2003:

1.328  Definition of Transporter or Non-Transporter and the role of the
Customs Broker

In the NPRM, the non-transporter is defined as "a person who owns food or
who holds, processes, packs, imports, receives, or distributes food for
purposes other than transportation".

The transporter is defined as "a person who has possession, custody, or
control of an article of food for the sole purpose of transporting the
food."

Clearly, FDA's intent is to group parties in the food product supply chain
into two categories for recordkeeping purposes and to establish a
documented chain of custody transfers.  However, this categorization does
not cleanly segregate some parties, such as customs brokers, into either of
the two classifications.

In attempting to assign these classifications to parties in the supply
chain for a shipment of food imported from Canada, we came to the
conclusion that the customs broker does not fit into either classification.

A customs broker can be designated to file entry on behalf of the importer.
This filing requires electronic submission of information to both the
Bureau of Customs and Border Protection (CBP) and FDA.  When acting in this
capacity, a customs broker assumes no physical control or ownership of the
imported product, and therefore neither classification, by definition,
applies.  Evidence of this inability to classify is demonstrated in the
following example:

For a shipment of food products exported from Canada, the importing carrier
(transporter) is required to record "the immediate previous source or
person from whom a transporter received an article of food."  This would
most likely be the Canadian shipper.  Subsequently, when the transporter is
required to document "the immediate subsequent recipient," they would
record the party to whom the shipment was delivered.  In neither case would
the customs broker be one of these parties.

The same would hold true for the non-transporters in this sample
transaction.  The Canadian shipper, (non-transporter) would designate the
carrier as transporter.  The shipper also would document their customer as
the non-transporter immediate subsequent recipient. The shipper would not
identify the customs broker as either transporter or non-transporter.

If acting as customs broker and freight forwarder, the customs broker may
file the entry information and/ or contract a carrier to move the shipment.
In this instance, the customs broker would then be designated as
transporter, as they mirror the role of the carrier in that their
activities aid in the movement and transportation of the goods.  In this
case we recommend that the customs broker be classified as a transporter
for the purposes of this rule.

1.361  Record Availability Requirements

Under proposed 1.361, records must be made available within 4 hours of a
request if the request is made Monday through Friday between 8 AM and 6 PM,
and within 8 hours at other times.

In most ports of entry, the hours of operation of the trade community are
established to mirror the hours of the commercial operations of the CBP.
If requesting documentation outside of those hours of operation, FDA could
encounter difficulty in contacting the appropriate parties from whom to
request records.  In addition, customs brokers typically have many types of
offices along the border.  Some of  these offices are merely release
offices with minimal administrative staff and record retention, similar to
FDA's district organizational structure.  When dealing with these offices,
it would be better if FDA requests were directed to a regional office.

We therefore recommend that the FDA establish a clear-cut and definitive
plan for communicating the requests for records and that the plan be
specific to offices with in a FDA district.  The plan must allow for the
parties involved to receive the request in such a manner that would allow
for the production of the records to be in accordance with the time frame
in the final rule.

The NBCBA appreciates the opportunity to comment on the proposed NPRM.

Yours truly,

Leman G. Bown, Jr.
President

Deborah A. Benish
Chair ? FDA Committee