From: Patricia Lovera [plovera@citizen.org]
Sent: Monday, August 09, 2004 2:08 PM
To: fdadockets@oc.fda.gov
Subject: Comment - Docket Number 2003P-0574

August 9, 2004

Food and Drug Administration
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Docket Number:  2003P-0574

Dear Sir or Madam:

On behalf of Public Citizen, a consumer organization with over 150,000
members, I am writing to oppose the petition that would establish a
regulatory limit for the food-borne pathogen, Listeria monocytogenes.

We oppose this petition for the following reasons:

1.  It attempts to overturn a zero-tolerance policy which the Food and
Drug Administration (FDA) has had in effect since 1985, and the Food
Safety and Inspection Service (FSIS) at the United States Department of
Agriculture has had in effect since 1989.  The petitioners seem resigned
to failure in eliminating this pathogen from food.  We believe that
industry needs to continue to work at improving sanitation in facilities
that process foods.  Furthermore, we believe that both the FDA and FSIS
need to enhance inspection regimes to deal with this pathogen.

2.  The petitioners may be creating a regulatory nightmare by
attempting to establish different standards for different foods when
dealing with this pathogen.  Food processors that produce different
types of foods in the same production facility could have multiple
standards in effect that could cause confusion for inspection personnel.
 

3. Petitioners seem to be relying on hypothetical arguments that
trading partners could ague that our zero-tolerance policy on Listeria
monocytogenes could be a trade barrier.  It seems to us that our trade
negotiators should insist on a "gold standard" for food safety and not
sacrifice our protections simply because other countries will not make
the same commitments or investments in food safety systems. 
Dumbing-down of our food safety standards in the name of trade should
not be tolerated.

4. Do we really want to take a chance with at-risk populations (i.e.,
the very young, the elderly, and pregnant women) with less than a
zero-tolerance standard for this pathogen?  It seems that the
petitioners cannot guarantee that their proposed limit would be safe for
these populations (see page 15 of petition).  Should FDA approve this
petition, it should then mandate that a warning label go on all foods
that have a less-than-zero tolerance standard that cautions at-risk
populations against eating such foods.

Sincerely,

Wenonah Hauter, Director
Public Citizen's Food Program




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Critical Mass Energy & Environment Program
Public Citizen
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