**California Fisheries & Seafood Institute**

**1521 I Street**

**Sacramento, CA 95814**

**(916)441-5560 Fax (916)446-1063**

[**www.calseafood.net**](http://www.calseafood.net/)

April 3, 2003

United States Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

ATTN: Mr. Stuart Shapiro

Docket No. 02N-0278

# Prior Notice of Imported Food Shipments: Docket 02N-0278

Dear Mr. Shapiro:

This letter responds to the proposed regulation published in the
*Federal Register* of February 3, 2003 that would require the filing of
a Prior Notice of every food article arriving in the United States.

The California Fisheries & Seafood Institute is the nation's largest
regional trade association representing all sectors of the consumer
seafood supply industry. Our members include exporters, importers,
traders, processors, distributors, wholesalers, and brokers of seafood
from around the world. These companies employee thousands of people,
contribute greatly to the nation's economy, and provide consumers with
continuous access to seafood of all types.

We applaud the FDA's efforts to draft regulations addressing the
tremendous role Congress assigned to the Agency as part of the
Bioterrorism Preparedness Act of 2002. The need for proactive border
enforcement is critical to protecting U.S. consumers from unsafe food
articles and we fully support the FDA's mission, commitment and
objectives in that regard. However, we are concerned that the
regulations as published would increase the costs and burdens of
importing food articles into this country so exponentially that the
entire industry is threatened. Because we are certain that this is not
the result the Agency intended, we respectfully submit to you the
following thoughts and comments.

We believe the proposed Prior Notice regulations are overly burdensome
and unnecessary, considering the following:

-   In recent years, the seafood industry has supported and complied
    with the HACCP program (Hazard Analysis and Critical Control Point)
    required by the FDA. The program establishes a complete paper trail
    for the movement of the product, including information on shipping,
    purchasing, manufacturing, processing, and packaging.

-   The current OASIS system requires the submission of information
    that, if presented to the FDA prior to arrival of shipments, would
    clearly satisfy the proposed requirement for the Prior Notice
    submission.

-   U.S. Customs already requires advanced manifest information for
    ocean bound cargo and will soon require advance transmission for all
    modes of transport in connection with all importations.

Requiring importers to submit import documents to multiple agencies is
not only a duplicative effort, but the additional work will undoubtedly
result in additional importing fees that will be handed down to the
importers and ultimately the consuming public.

It is troubling that the FDA believes a coordinated agency requirement
for a single pre-arrival submission is impossible to implement. The
BioTerrorism Preparedness Act of 2002 requires that the FDA increase
communication and information sharing between agencies, but the proposed
rule specifically requires no such communication or sharing of
information.

Further, many of the seafood products imported into the country are
highly perishable. The duplicative filings and the substantial time
involved in verification of information could lead to products becoming
unmarketable as they sit at the ports while brokers work feverishly to
obtain the extraordinary amount of supply chain detail the FDA believes
is necessary to protect the nation from an unsafe food supply.

We do not believe that one entity will have the ability to verify all of
the information required on the Prior Notice nor should any entity bear
such a responsibility. If the importer or his broker provides the FDA
with information to sufficiently identify the imported article \-- entry
information, place of manufacture, identification of manufacturer,
shipper and importer, country of origin and anticipated arrival
information \-- then, not only is this sufficient to ensure immediate
recall of tainted goods and to facilitate arrival inspections, but it is
also information that the FDA will be able itself to verify as to
accuracy.

The proposed Prior Notice regulations will raise the cost of importing
products into this country and will unnecessarily delay the availability
of these products to the American consumers. Moreover, the importing
community will suffer tremendously and may, in fact, be eliminated
entirely. We believe this is unfortunate and unnecessary.

Accordingly, we urge the FDA to reconsider its regulations and to
particularly consider how its obligations under the BioTerrorism
Preparedness Act of 2002 may be fully met by coordinating directly and
sharing information with U.S. Customs and other federal agencies.

Respectfully submitted,

Bob Stilwell

President, California Fisheries & Seafood Institute

Vice President, Long Beach Seafood Company