From: William Hastback [wghastba@gw.dec.state.ny.us]
Sent: Friday, July 19, 2002 4:06 PM
To: fdadockets@oc.fda.gov
Subject: Regarding FDA Docket No. 02N-0278

Regarding FDA Docket No. 02N-0278

 Proposed Section 307 (Prior Notice of Imported Food Shipments) -
requires that prior notice of food shipments be given to FDA.   The
notice must include a description of the article, the manufacturer and
shipper, the grower (if known), the country of origin, the country from
which the article is shipped, and the anticipated port of entry.  The
Secretary, through FDA, must issue final regulations by December 12,
2003. 

 It seems unlikely that FDA could possibly have enough resources to
enforce such regulations.   At present FDA and Customs are almost
completely  ineffective in preventing raw or frozen molluscan shellfish
products exported by non-MOU nations from entering the U.S.  Dozens of
shipments of molluscan shellfish enter the U.S. weekly, if not daily,
from China and other countries that have not signed a
memorandum-of-understanding with FDA agreeing to implement their
shellfish sanitation program in a manner that assures a level of public
health protection equivalent to that of the National Shellfish
Sanitation Program (NSSP) of the United States. 

 This failure to prevent the entry of tons of such molluscan shellfish
products from non-MOU countries occurs despite FDA's own seafood HACCP
regulations (21 CFR Parts 124 and 1240) adopted in December 1995.  Said
regulations clearly specify that shellfish that do not originate from an
MOU country, or which cannot be proven to be produced in a manner
equivalent to the NSSP, are defined by those regulations as adulterated
and will be denied entry.  Yet tons of such shellfish from many such
countries is routinely NOT being denied entry, even when FDA knows that
the country of origin is a non-MOU country and/or when no credible
evidence is produced that the shellfish were produced in accordance with
the HACCP regulations adopted in 1995.  Apparently, FDA counsel is of
the opinion that FDA's own regulations are so impotent that FDA cannot
deny entry to such adulterated products.

 FDA's feeble effort to curtail the distribution of shellfish from
non-MOU countries is to ALLOW it into the country and then ask the
various states' shellfish sanitation programs to embargo the product. 
FDA does this knowing full well that states' shellfish and enforcement
programs are nearly all operating at the limit of their resources.  In
fact, FDA's most recent program evaluation report found one northeastern
state's shellfish enforcement program element to be nearly out of
compliance with the requirements of the NSSP, yet it continues to allow
shellfish from non-MOU countries into that state and hopes that state
can embargo and destroy such adulterated product, creating additional
work for that state's shellfish enforcement unit.  

 If FDA cannot enforce its current regulations that apply only to
seafood and molluscan shellfish, which make up but a small percentage of
the foreign foods entering the U.S., even when those foods are
adulterated under its own regulations, how will the new proposed
regulations, Section 307 (Prior Notice of Imported Food Shipments),
which govern an even broader spectrum of food products which may not be
adulterated, ever be effectively enforced by FDA ?

William Hastback
6 River Heights Drive
Smithtown NY  11787