From: Stan Jacobsen [harmony@citcom.net]
Sent: Monday, March 26, 2001 11:48 AM
To: fdadockets@oc.fda.gov
Subject: Comments on FDA's Proposed Rules on Genetic Engineering

Dear Sir or Madam:
 
I am a former Assistant United States Attorney and Special Agent with the Federal Bureau of Investigation.  Five years ago, because of the tremendous positive effects of Traditional Chinese Medicine on my health, I left the practice of law to study this incredible medicine.  Today, I am a licensed acupuncturist in North Carolina.   
 
My ten-year tenure in the Federal Government was extremely educational. I understand personally how working within large bureaucracies can de-humanize employees and cause them to accept guidelines and procedures that may be beneficial to the employer that are not beneficial to the general public.  Only after I left my government position did I start to question the process. I was able to get back to my humanity.  I am pleading with you to do the same in regard to your proposed rules on Genetic Engineered Foods (GE).  Please, take the time to comprehend the long term effects of your decision on fellow human beings.
 
During my internship and practice, I have seen the detrimental effects of chemical exposure to human immune systems. Many people have extreme chemical sensitivities, chronic allergies or chronic, hard to treat, conditions. Some of these chemicals are ingested. Some of them have been approved by the FDA.  (Bill Moyers has a special on PBS this week detailing the results of our overexposure to chemicals). We are just beginning to realize the long-term effect of exposure to hundreds of chemicals in our environment.  However, unlike conventional chemical 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!
 
I disagree with your proposed rules on the following points:
 
 * They do not require mandatory pre-market safety testing or environmental review.
 
*  The do not require mandatory labeling of genetic engineered foods.
 
*  They restrict voluntary labeling of non-genetic engineered foods.
 
*  They require a mere letter of notification prior to the marketing of a genetic engineered food.
 
*  They fail to ensure public access to adequate information for independent review.
 
*  They are supported by industry and opposed by consumer groups.
 
 
You must require mandatory pre-market comprehensive environmental review.  As I alluded above, this could be Pandora's box you are opening because we don't know what irreparable damage could occur.
 
 
You must require mandatory pre-market long-term health testing!!  Genetic engineered products could be toxic, causing toxic responses.  They could be lower in nutritional value and could compromise human immune systems.  The problem is that with your proposed rules, we will never know!
 
You must require mandatory labeling of genetic engineered products.  Without it, 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 products liable as hazardous products.
 
You must end your cozy relationship with the industries you purport to regulate.  Your employment guidelines encourage conflicts of interest.  How can you allow the revolving door that exists between the FDA and Biotech companies?
 
 
This is a crucial time in the history of the FDA.  Are the human beings that receive this e-mail or work in proposing rules conscious to the impact of the decisions that you make every day of your career or are you aligned with the interests of the biotech companies that appear before you?  Please reconsider these proposals.
 
 
Sincerely,
 
Vickie L. Johnson, JD, L. Ac.