July 13, 2004

Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane

Room 1061

Rockville, MD 20852

**RE: Docket Nos. 02N-0278 \-- Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002**

The Customs and International Trade Bar Association (CITBA) welcomes the
opportunity to comment on the Food and Drug Administration's (FDA)
proposed rules to implement the prior notice of imported food provisions
of the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (the Bioterrorism Act). CITBA is a bar association
consisting of attorneys practicing primarily in the area of customs and
international trade law.

CITBA strongly supports national efforts to reduce the risks of
bioterrorism. However, we would like to emphasize the need for the rules
governing importation of food to be clear, consistent, and well
coordinated with the various other regulatory regimes that already
exist. The security and protection that is achieved by the Bioterrorism
Act will be maximized only if the system takes into account the
realities of commercial operations, and is understandable and logical to
the thousands of affected importers. Furthermore, Congress was clear in
passing the Bioterrorism Act that an appropriate balance must be
achieved between the need for additional security and the needs of
industry in facilitating legitimate trade. Without such a balance, the
proposed rule has the potential not only to increase import costs
significantly and unnecessarily but also to delay and impede the import
of products that are regulated by the rule.

As a general matter CITBA is concerned about the numerous
inconsistencies between the requirements proposed by the FDA's notice
and the existing Bureau of Customs and Border Protection (CBP)
definitions and practices. These differences in treatment are likely to
lead to widespread confusion and compliance problems, and undermine the
security improvements made in recent CBP initiatives. For this reason,
CITBA strongly supports the initiative announced by FDA and CBP to
explore ways to improve coordination between the two agencies.

In particular, CITBA urges the two agencies to permit importers who are
participants in the Customs Trade Partnership Against Terrorism (C-TPAT)
and Free and Secure Trade (FAST) programs to comply with their prior
notice obligations in a manner that does not undermine the benefits of
participation in these programs. C-TPAT and FAST improve U.S. security
on a number of levels, including the risk of bioterrorism, and help
focus limited border resources on higher risk cargo. FDA and CBP should
therefore be careful not to remove incentives for participation in these
programs by making importations of food items more cumbersome than other
types of entries. The companies participating in these programs have
made a substantial commitment to improving security by putting in place
appropriate security systems, and submitting to periodic review of those
systems by CBP. We believe this would also assist the FDA in
prioritizing shipments for scrutiny and in delegating resources to those
shipments where increased scrutiny is merited and/or the shippers and
carriers are not known. Coordination in risk analysis should be further
explored; for example, FDA might follow the CBP model wherein C-TPAT
membership is a positive factor in risk assessment for specific
shipments.

CBP has recognized the superiority of an account-based approach to
commercial compliance as well as security. Account-based approaches are
superior because they focus limited resources on higher risk areas. A
shipment-by-shipment approach to security risk analysis imposes
tremendous burdens on traders and regulators, and does not permit a
meaningful assessment of security risks given the high volume of
expected shipments. For these reasons, CITBA urges the FDA to continue
discussions with CBP in regards to the security systems they already
have in place.

CITBA is grateful for the efforts that the FDA has made so far to create
a workable Prior Notice system that balances food security with the
realities of the import trade. Thank you in advance for your attention
to the issues raised in this letter.

Respectfully submitted,

Melvin S. Schwechter\
President\
Customs and International Trade Bar Association