From: Tom Eberhard [eberhard@icd.teradyne.com]
Sent: Thursday, March 29, 2001 11:06 AM
To: fdadockets@oc.fda.gov
Cc: Matias, John; Erni, Roland; Eden Miller; Christine Earley; sungrim
kim; Tom Eberhard
Subject: Docket 00N-1396 & Docket 00D-1598


Dear FDA,

I would like to comment on your proposed new rules for
genetically modified foods. It's pretty simple actually:
Genetically modified foods should be considered drugs,
and as such, should undergo rigourous testing for
side effects, presence of new toxins, danger to the 
environment, etc.

Would you put prozac in tomatoes and sell them on 
foodshelves without labeling them? Of course not, 
(at least, I hope not, but given your past record 
I am a bit cynical) and therefore any genetically
modified food must be labeled as such. 

As a consumer, I have the right to choose what I
eat. I want to know what I eat. Not labeling 
genetically foods also goes against capitalism and
the american way: let the consumers and the market 
decide what they want. I don't have a problem with 
other people eating whatever they want, but I don't 
want to know what I eat. I am not a guinea pig for
biotech companies!!

Your proposed rules are a slap in the face of 
consumers, and must be radically changed:

- the new rules must require mandatory pre-market 
  safety testing of genetically modified foods. 
  This safety testing must be done by independent
  labs, and be more extensive than the testing done when
  developing new drugs. The foods must be labeled
  with the known side effects caused by consumption.

- the new rules must require pre-market environmental
  review. Genetically modified foods are a new
  environmental threat and should be treated as such,
  because a genetically modified food is a living
  system capable of reproducing itself. (so called
  "terminator genes" are not 100% effective) Once
  the genetically modified food is out, it is 
  virtually impossible to remove it from the environment.
  (On those grounds alone, genetically modified foods
  should be illegal and banned.)

- the new rules must require mandatory labeling of GE
  foods, including the statement "Genetically modified
  foods have not been proven 100% safe for consumption,
  and may cause sickness, or death"

- the new rules must not prevent voluntary labeling of non-GE
  foods. (You have no chance of passing this. It's called 
  freedom of the press; so you might as well pretend to be 
  on the side of consumers with this one.)

- the new rules must require a letter of notification
  prior to the marketing of a GE food, and a 10 year waiting
  period between the time this letter is received and the
  time the GE food is marketed. The new rules must make
  all such letters publicly accessible within 21 days of
  receipt by the FDA. Marketers of GE foods may not send
  the letter of notification until all genetical modifications
  have been made. A new letter must be sent for each new
  modification made, and each such new GE food must be 
  treated as an entirely new drug, with its associated 10 year
  waiting period.

- the new rules must ensure that the public has access
  to all information about a GE food. The information
  must be independently reviewed.

- the new rules must put the safety of consumers, the safety
  of the environment, and the integrity of non-GE and organic
  foods before the interests of the GE food producers and their
  short sighted profits. The best way to do this is to 
  properly label GE foods, and let the consumers and market
  forces decide.

- 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.


Sincerely,

Tom Eberhard.