From: Robert Roman [organicman_cr@yahoo.com]
Sent: Tuesday, December 07, 2004 11:31 AM
To: Dockets, FDA
Subject: Docket No. 2004D-0369

Robert Roman
President
Organics In America
#SJO26, 1601 NW 97th Ave. 
Doral, FL 33172


December 7, 2004

FDA Dockets
,  


Dear FDA Dockets:

My comments are for Docket No. 2004D-0369 regarding the FDA's "Draft 
Guidance for Industry: Recommendations for the Early Food Safety 
Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties 
Intended for Food Use; Availability."

I object to the policy outlined in the Draft Guidance for Industry. It 
permits the continued contamination of our food and seed supply with 
genetic material from thousands of biotech crop experiments. And it falls 
to address the major shortcomings of the FDA's regulation of crops 
produced through biotechnology.

The FDA acted irresponsibly in 1992 when it initially addressed the safety 
evaluation of genetically engineered crops and determined them to be 
"substantially equivalent" to non-genetically engineered crops. 
Genetically engineered crops contain antibiotic-resistant marker genes, 
viral promoters and foreign proteins never before consumed by humans. 
These factors are not found in crops produced through normal means of 
hybridization. These crops are NOT "substantially equivalent" and it is 
beyond common logic to represent them with this status.

Rather than recognizing and dealing responsibly with the shortcomings of 
your initial 1992 determination, the FDA is continuing to jeopardize the 
safety of the American public by attempting to fine-tune your flawed 
regulatory scheme.

Under current FDA regulations, a biotech company bringing out a new 
product is not even required to notify your agency. Even though most 
companies have notified the FDA until this point, there is no guarantee 
that they will continue to do so on an ongoing basis. The lack of a 
mandatory notification requirement leaves the door open for a wide range 
of abuses at any point in the future. These abuses could run the gamut 
from mischievous behavior, to negligence, to deliberate acts of terrorism 
in an attempt to contaminate the American food supply.

Further, the voluntary review process outlined in the Draft Guidance for 
Industry is most likely inadequate to actually determine potential 
problems. The proposed review does not involve safety tests in animals, 
and it excludes testing for unintended effects caused by genetic 
engineering. It also sets no limits on the amount of contamination allowed 
in foods. 

The FDA approach to regulating genetically engineered foods appears to be 
designed to promote the biotech industry rather than protect the health of 
the American public. Rather than protecting the food supply, this Draft 
Guidance for Industry appears to be designed to provide biotech companies 
with legal cover for contaminating the food supply with experimental 
biotech traits.

We only need to look at the contamination of the food supply from StarLink 
corn a few years ago to get evidence that the FDA has shirked it 
responsibilities. Why was it that the problem with the digestibility of 
the protein contained in StarLink corn was discovered by the Environmental 
Protection Agency rather than the FDA? The answer is that your agency 
wrote yourselves out of an adequate review process with your 
"substantially equivalent" and voluntary notification guidelines.

And perhaps it would be worthwhile to remind the FDA that it was the 
non-profit organization Friends of the Earth who discovered the 
contamination of the American food supply with StarLink corn. If Friends 
of the Earth had not discovered the contamination, StarLink corn may still 
be in the U.S. food supply causing allergic reactions in thousands of 
unsuspecting citizens. 

The FDA's policy for regulating genetically engineered crops is broken and 
needs a major overhaul. The band-aid approach that this Draft Guidance for 
Industry provides is totally inadequate. 

The FDA needs to develop an entirely new policy for regulating crops 
produced through agricultural biotechnology. The new policy should include 
the following requirements:

1) mandatory labeling of all genetically engineered foods
2) mandatory safety testing of recombinant-DNA plants similar to what is 
required for a new drug or food additive 3) all biotech crop experiments 
should be conducted in greenhouses or similar controlled environments

Only when the FDA adopts these three policy requirements will the public 
be able to rest assured that biotechnology-derived plants will not cause 
health problems and the contamination of the American food supply.

Sincerely,


Robert B. Roman
President
Organics In America