From: Center for Food Safety [action@foodsafetynow.org]
Sent: Friday, March 16, 2001 9:55 PM
To: FDA Commissioner
Cc: president@whitehouse.gov; vice.president@whitehouse.gov;
fdadockets@oc.fda.gov; fdadockets@oc.fda.gov
Subject: Oppose the New FDA Regulations on GE Foods!

FDA Commissioner 
Dockets Management Branch (HFA 305)
Food and Drug Administration
5630 Fisher's Lane, rm. 1061
Rockville, MD 20852

RE: Docket No. 00N-1396, and 00D-1598

Dear FDA,
 
I am sickened and baffled by your new policies on genetically engineered 
 (GE) foods. You have any no idea what effect these products will have on 
humans and yet you are willing, against all logic and basic concern for 
human vitality, to subject the population to a great unsupported 
experiment. An experiment which, should it prove fatal, cannot be undone 
and which will haunt humans and the land for years to come. It's just 
plain dangerous! 

Despite overwhelming consumer demand, your agency still fails to require 
safety testing and mandatory labeling for GE foods. Your notification 
policy is an insult to consumers, and irresponsibly ignores strong 
scientific evidence of numerous potential health and environmental risks 
to GE foods. You should be aware that these foods could be toxic, could 
cause allergic responses, could have lower nutrition value, could 
compromise immune responses in consumers, and could cause irreparable 
damage to the environment. 

I am also greatly opposed to your new voluntary labeling policy, which 
denies consumers a basic right to know. 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 
will also be deprived of the critical knowledge they need to hold food 
producers liable should any of these novel foods prove hazardous.

Your agency admits to receiving more than 50,000 comments last year 
regarding genetically engineered foods. You concede: Most of the comments 
that addressed labeling requested mandatory disclosure of the fact that 
the food or its ingredients was bioengineered or was produced from 
bioengineered food. Yet you ignore the will of the public saying the 
comments did not provide data or other information regarding consequences 
to consumers from eating the food. The truth is there has been ample 
evidence submitted to the FDA revealing that these foods are NOT 
substantially equivalent  to non-genetically engineered foods. Yet your 
agency continues to ignore this evidence.

Studies have shown that biotech soybeans contain altered levels of 
nutrients such as isoflavones. They have been shown to have higher levels 
of Kunitz trypsin inhibitor, a known antinutrient and allergen. 
Genetically engineered foods contain antibiotic marker genes and many 
contain built-in pesticides. These are not found in non-genetically 
engineered foods. I do not want to eat these biotech foods, but without 
mandatory labeling I have no choice.

Last year, Monsanto admitted to finding unexpected gene fragments in 
their genetically engineered soybeans. What other unexpected gene 
fragments are contained in other genetically engineered foods? The truth 
is that the FDA does not know, because these experimental foods have not 
been adequately tested. New proteins never before consumed by humans are 
being created and brought to market without any extensive tests being done 
to show that they are not causing allergies, cancer or other diseases.

In the case of genetically engineered foods, the FDA has done a poor job 
of protecting the safety of consumers. Please remember that the potential 
allergies created by the ingestion of StarLink corn completely escaped the 
FDA regulatory guidelines. It was the EPA that discovered the digestive 
problems associated with StarLink corn.

The FDA has been accused of being a pawn of biotech industry. It is 
documents such as your Draft Guidance for Industry that leads many to feel 
this belief holds some truth. In your Draft Guidance you question whether 
manufacturers who choose not to use genetically engineered ingredients 
should be able to label their products as GMO Free. It is bad enough that 
the FDA does not require the mandatory labeling of genetically engineered 
foods. Now your agency even seems to be exploring the idea of restricting 
the ability of a manufacturer to let consumers know the products are not 
genetically engineered. Such regulatory restrictions would be an 
outrageous act of censorship by the FDA.

Genetically engineered foods are required to be labeled in the European 
Union nations, in Japan, Australia, New Zealand and other countries. 
Recently, both the E.U.-U.S. Biotechnology Consultative Forum and the 
Consumer Federation of America recommended mandatory labeling of 
genetically engineered foods. The FDA should stop working on behalf of the 
manufacturers of genetically engineered foods and begin to work for the 
safety and rights of the American public. I insist that genetically 
engineered foods be labeled!

I trust you will take my concern along with the thousands of others into 
serious consideration.


Sincerely,
Martha Hoyle


Martha Hoyle
834 Grey Ave.
Evanston, Il, 60202

CC: 
The President
Vice President Dick Cheney
FDA Dockets Management [Docket No. 00N-1396]
Senator Richard J. Durbin
Senator Peter Fitzgerald
Representative Janice SchakowskyFDA Dockets Management [Docket No. 00D-1598]


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