From: Karen M Krause [kkphoto@juno.com]
Sent: Wednesday, April 04, 2001 3:20 AM
To: fdadockets@oc.fda.gov
Subject: Docket No. 00N-1396 & Docket No. 00D-1598

FDA Commissioner, Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, ND 20852



The FDA's proposed new rules on genetically engineered (GE) foods are
alarming.  Regulations are needed, yes.  And is must be remembered that
the intent of FDA regulations are for the protection of the health of the
consumer.  Or does it have a new mandate?  

There must be mandatory pre-market safety testing, of a strictly ethical,
informed nature, to determine, over sufficient time, the allergic and
immune responses in consumers, as well as nutritional value.

There must be mandatory pre-market environmental review.  Any science
that does not support the claims (of safety and benefit - to the
environment and the consumer) of the developers and producers of GE foods
must be taken into serious consideration.  And answered satisfactorily. 
For GE crops to be able to contaminate (yes, contaminate) an organic
farm's produce is outrageous.  Those farmers striving to do right by the
environment and the consumer, by growing our food organically should be
rewarded not crippled.  Anyone asking the birds and the bees (and
butterflies!) how fields of GE crops affect their mission?  The science
to declare GE crops safe for the environment is not there, PR
declarations notwithstanding.

There must be mandatory labeling of GE foods.  Without labeling, there is
no way for a consumer (or researcher) to know if a GE food was
responsible for an allergic reaction, or the an impaired immune system. 
Food sensitivities may take many forms, tracking would be extremely
difficult.  This is unconscionable.  The consumer must have control at
the point of purchase, at the least, over what foods they consume, and be
assured of the nutritional content and absence of known allergens for
that consumer.  

The "Notification" policy cannot be seen as a safeguard, as it stands.  

What is happening?  Who is this watchdog agency guarding - and against
whom?  Our safety and that of the environment of which we are a part and
from which we derive our (and future generation's) life, health and
potential should be of paramount importance to an agency of the
government of, for and by the people.  Which, in these new rules, seems
to be of, for and by the corporations.  Please reconsider your rules
announced on January 18,2001.

Non-GE food labeling must be allowed.  The consumer must be allowed their
own stricter standard for food safety.  Food.  Choice.  Is this America? 
We are talking the basic stuff of life.  Water, too.  And what do we know
about long- (or even short-) term farming of GE foods and the effect on
the water supply and therefore us and all living things in and by that
affected water?  What we think we know and the facts are not necessarily
the same thing.  

Good science exists.  Many entities with good intentions for the
environment and for the people exist.  Let's put it - and them - all to
use in the best possible rules that are truly safeguards.

Thank you for your consideration of the above.

Sincerely,

Karen M. Krause-Kimmel
8 Beach Street
New York, NY 10013