From: Philip Friedman [phifri@frii.com]
Sent: Sunday, March 25, 2001 10:13 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

March 25, 2001

[Via email: fdadockets@oc.fda.gov]

Docket 00N-1396 & Docket 00D-1598
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket 00N-1396 & Docket 00D-1598

Dear Food and Drug Administration:

The Food and Drug Administration (FDA) has recently announced new rules
and guidance on genetically engineered (GE) foods. Unfortunately,
despite overwhelming consumer demand, the agency has still failed to
require safety testing and mandatory labeling for GE foods.

Instead of mandating safety testing, the FDA’s new rule merely requires
that food producers notify the agency before marketing a GE food. There
is strong scientific evidence of numerous potential health and
environmental risks of GE foods. These foods could be toxic, could cause
allergic responses, could have lower nutrition value and could
compromise immune responses in consumers. 

Under FDA’s new notification rule GE foods will reach supermarket
shelves without any required testing for these human health problems,
much less any review of their environmental risks. As a result, millions
of consumers will continue to be unknowing guinea pigs testing the
safety of these foods.

THIS IS TOTALLY UNACCEPTABLE TO ME.

The proposed rules:
* Do not require mandatory pre-market safety testing
* Do not require pre-market environmental review
* Do not require mandatory labeling of GE foods
* Restrict voluntary labeling of non-GE foods
* Require a mere letter of notification prior to the 
  marketing of a GE food
* Fail to ensure public access to adequate information 
  for independent review
* Are supported by industry and opposed by consumer groups

I would like to add the following into the public record on the proposed
new rules:

* THE FDA MUST REQUIRE MANDATORY PRE-MARKET COMPREHENSIVE ENVIRONMENTAL
REVIEW. Unlike conventional pollutants, where a given amount of
pollutant causes a limited amount of damage, a small number of mutant
genes could have a population explosion and reproduce forever, causing
unlimited and irreparable damage.

* THE FDA MUST REQUIRE MANDATORY PRE-MARKET LONG-TERM HEALTH TESTING. GE
products could be toxic, cause allergic responses, have lower
nutritional value, and compromise immune responses in consumers.

* THE FDA MUST REQUIRE MANDATORY LABELING OF GE PRODUCTS. Without
mandatory labeling, neither consumers nor health professionals will know
if an allergic or toxic reaction was the result of a genetically
engineered food. Consumers would be deprived of the critical knowledge
needed to hold food producers liable should any of these novel products
be hazardous.

* THE FDA MUST END ITS COZY RELATIONSHIP WITH THE INDUSTRIES IT PURPORTS
TO BE REGULATING. People have been allowed to work for a biotech
company, then work for the FDA writing [and re-writing] regulatory rules
on that company’s product, then go back to working for the company. Many
FDA advisory committee meetings had at least one conflict of interest.

Sincerely yours,

Phil Friedman
201 So. Grant Ave.
Fort Collins, CO 80521
970 493-2959
phifri@frii.com