From: Derek Pulvino [dpulvino@agraus.com]
Sent: Saturday, March 24, 2001 6:08 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

To whom it may concern,  

I have previously written concering the need for disclosure to be part of the regulations concerning genetically engineered food; I would like to take this chance to re-present my previous point.  

At this juncture, genetically engineered food is a new creation in our world, and as such we really have no firm basis or body of evidence to make calls on; any and all facets of the impact from these products is an unknown.  We can develop theories, look at logical conclusions, try and conceptualize possible impacts, look to other similar natural situations, or even do minor studies.  The truth is though, none of this could ever approach the true scope of impact;  something like this is above and beyond what we have done to date.

Facts being facts, even if we're sure, or even pretty well comfortable with any one portion of the dilemna, for example nutrition, or immunal system responses, there are so many other potential impacts that the case would still not be firmly shut.  I'm not saying that I have evidence that something deletrious could happen as related to the introduction of genetically engineered food, but what I am saying is the possibility does exist for unforseeable consequences to arise.

Now I don't ask that nothing of this nature be pursued, or even produced-the potential upside is great-but that the progress in this arena be undertaken with a firm footing in liabilities and disclosure.  If any kind of human or ecological impact was to occur as related to genetically engineered food, and those products were not labled, one might never know.  

Perhaps this is what the FDA and industry wants, but these entities do not exist in a vacuum.  Any impact, be it to the human or natural ecosystems would invariably impact these companies.    

Along those lines, I do feel that a callout is necessary on these products.  I also feel that the producers, researchers, and otherwise implementing parties should proceed with an understanding of the implications of what they are doing, along with a clearly defined path of responsibility to include mitigation of "renegade strains, or even financial responsibility for health impacts.  

Yes, none of this may happen, but with that possibility, a responsible position would invariably be a very profitable venture.  However, if the downside does occur, the perpetrators should not be allowed still consider it to have been a "profitable venture."  Please don't regulate to make this so.  

So, to sum it up, along with a decision to proceed and regulate genetically engineered products, I don't think the labeling/disclosure of these items is something that should be discarded. Not only do I feel that any item that has been genetically engineered should be labeled as such, but also that laws should be written to require companies to take full responsiblity for the impact of their "babies."  That way, we can rest assured that we have done our best, most thoroughly enjoy the fruits of our labors. 

Please respond with any comments or questions you may have.

Sincerely 

Derek Pulvino