From: Larry Zimmerman [larryz@mac.com] Sent: Saturday, March 24, 2001 3:33 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 I understand that the Food and Drug Administration is now accepting public comment on its proposed new rules on genetically engineered (GE) foods. I also understand that 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 a total give away to the biotech industry I would like to think that a federal organization such as the FDA was beholden to the American people, and was formed to perform some function useful to the people. How naïve. How very wrong. Instead the FDA is totally controlled by the same industries it is supposed to be regulating. I wrote to express my irritation at your proposed rules for organic food. Thankfully, you realized you could not hoodwink people on that issue. But you have obviously learned nothing. It makes me very angry to see you doing your best to support an industry which has no concern whatsoever for the safety or well being of the people of this planet, or of the planet itself. * 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. It has also been shown that these novel gene sequences can cross species barriers and cause unknowable changes to the environment. We can create Superfunds to clean up toxic wastes. Nothing whatsoever can be done to reverse the damage that GE will inevitably produce. It would only take one big GE mistake to destroy life on this planet. How can you be willing to take such risks? * 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. People have already died, and thousands have been injured by GE products. Not disclosing such problems does not make them go away. You say there is no difference between GE foods and natural foods. The shills from the industry say that the safety of GE is well researched. There is no scientific basis for such ridiculous claims. It only goes to show that you have no understanding, or more likely choose not to understand the real implications of GE. Genetic engineering is not a science. It is a crap shoot. Something good could come out of it. It is far more likely that the results will be incredibly dangerous. The expression "a little knowledge is a dangerous thing" applies to GE more than you care to believe. * 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. You seem to think that by not talking about GE, no one will notice that it exists. You are unwilling to even let consumers make the choice. I resent being made a guinea pig to determine whether every new GE food that comes along is safe or not. It is already extremely difficult to find food that is not tainted by GE. You do not allow people to know about the dangers, and then say nobody cares. We very much care. And if you told people about GE you can be sure that the outcry would get you fired or in jail. * The FDA must end its incestuous relationship with the industries it purports to be regulating. People have been allowed to work for a biotech company, then go work for the FDA for the sole purpose of 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. Maybe you think that such practices are common, but they are wrong, immoral, and destroy what very little faith people have in government being able to act responsibly. Please reconsider your proposed rules. They are bad rules. They are ill-considered. They are criminal.