From: Ellen Finkelstein [efinkl@kdsi.net]
Sent: Saturday, March 31, 2001 12:54 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1369

Dear FDA,

I feel very strongly that:

* 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. Here's a personal story: my mother took
DES, an artificial form of estrogen given to women in the 50's to prevent
miscarriages. No significant negative effects were ever found in the women
that took the drug and it worked. (I was born!) However, in the children
(mostly girls but also boys) there were serious negative effects -- in
girls, increased incidence of cervical cancer, problems getting pregnant and
in pregnancy (such as ectopic pregnancies); -- in boys, increased incidence
of underdeveloped testes & low sperm counts. These effects were only found
as the sons & daughters reached sexual maturity -- 20 years later! For this
reason, long-term testing is a must.

* 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. In addition, many people have ethical and religious reasons
to avoid GE products and we have a right to follow these beliefs and cannot
without labeling.

* The FDA must stop hiring people who work 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.

* There must be no restriction on voluntary labeling of GE foods, or
voluntary labeling of foods as non-GE. Just as the labeling of organic foods
is not considered a threat to non-organic foods, the labeling of non-GE
foods should not be considered a threat to GE foods. Companies have the
right to say that their foods have no artificial color or flavor and
generally to market their food to people who will appreciate what they are
selling. The same should be true for non-GE foods.

Ellen Finkelstein

ellenfinkl@bigfoot.com