From: David Collins [d.r.collins@usa.net]
Sent: Monday, April 30, 2001 10:46 AM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

Dear FDA Commissioner,
The proposed Food and Drug Administration (FDA) regulations fail to
require labels or safety tests on genetically engineered (GE) food.
The new rules continue to deny Americans the right to know what is in
our food, while protecting the economic interests of biotech
corporations.

Labeling GE foods would protect the public from potential hazardous
health effects such as food allergies and toxicity that can only be
traced if GE foods can be identified. By refusing to require both
labeling and mandatory pre-market safety testing of foods, the FDA
puts consumer's health at risk, ignores possible environmental
hazards, and fails to satisfy the overwhelming desire of American
consumers to exercise freedom of choice in the marketplace. 

It is not enough to require that firms simply notify you of their
intent to market a food produced with genetic engineering; this is no
substitute for thorough pre-market safety testing. The proposed
"voluntary labeling" guidelines will do nothing to inform consumers
of the presence of genetically engineered ingredients in their food,
because biotech companies and food manufacturers have vehemently
opposed labeling in the past and will not voluntarily label their
foods in the future. Therefore, I urge you to keep all genetically
engineered ingredients and crops off the market unless or until: 1)
Independent safety testing demonstrates they have no harmful effects
on human health or the environment; 2) They are labeled to ensure
consumers1 right-to-know; and 3) The biotechnology corporations that
produce them are held responsible for any harms they may cause.

* 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 the regulatory rules on
that company's product, then go back to working for the company. 
Ninety-two percent of FDA advisory committee meetings had at least one
conflict of interest.

The FDA's track record in the area of GE has been criminal.  It is 
time for the FDA to assume its proper role of protecting the health
interests of the people it is supposed to serve and protect -- the 
citizens of America.

Sincerely,

David Collins