From: Gary Vesperman [vman@skylink.net]
Sent: Thursday, March 29, 2001 9:58 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

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

Dear FDA Commissioner,

Please accept the following comments concerning Docket 00N-1396 & Docket
00D-1598 - Guidance for Industry. Voluntary Labeling Indicating Whether
Foods Have or Have Not Been Developed Using Bioengineering:
:
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.

Despite overwhelming consumer demand, the FDA has failed to require health
and ecological safety testing or mandatory labeling, and thus puts the
public's health and our environment at risk and deprives the public of the
right to know or choose what it is eating.

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

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 the FDA 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.

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.

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 financially
responsible with substantially large bonds for any harms they may cause.

Sincerely,

Gary C. Vesperman
3123 Trueno Road
Henderson, NV 89014-3142