From: Skra [skra@flash.net]
Sent: Monday, March 26, 2001 12:14 AM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

To Whom it may concern:

Please note my point of view on the following issues regarding genetically
engineered products:

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.


Thank you for your attention,
Sharon Kraus