AN OPEN LETTER TO GOVERNOR THOMAS J. VILSACK



Please Be Aware You Are Making Claims About the Safety of

Genetically Engineered Foods That Are Blatantly False




Steven M. Druker
Executive Director

Alliance for Bio-Integrity

www.biointegrity.org





September 4, 2002



Dear Governor Vilsack:



I am concerned, and surprised, that you continue to vigorously promote
genetically engineered foods despite substantial evidence I directly
presented to you showing (a) that they pose unique risks to human health,
(b) that the FDA¹s own scientific experts have cautioned about these risks
and (c) that sound science has been circumvented and the facts consistently
distorted in order to get these foods on the market.  Further, I am
concerned that you continue to mislead the public by making false claims
about the safety of genetically engineered foods and that the Governors
Biotechnology Partnership, which you founded and chair, is likewise
misrepresenting the facts.  This is especially puzzling because the evidence
I gave you provides ample basis to recognize the inaccuracy of the various
misrepresentations being made by you and the Partnership.



Since I know you are essentially a good and decent man, I expect you will
want to make the necessary changes as soon as possible.  The following
paragraphs are designed to assist by reviewing the pertinent facts.



On May 31, 2001 you held a town meeting in Fairfield at which I informed
you, in the presence of the hundreds of citizens in attendance, that the
U.S. Food and Drug Administration had permitted the marketing of genetically
engineered (GE) foods even though its own scientists had repeatedly warned
about their unique health risks.[i]  In particular, I explained:



·        By bringing a lawsuit against the FDA, my organization obtained
copies of its internal files on GE foods.

·        These files clearly reveal that the FDA¹s scientific experts
conducted a comprehensive review of GE foods and overwhelmingly concluded
that the process of genetic engineering is inherently hazardous and that
every new food it produces entails a unique set of health risks.  They
warned that no GE food could be considered safe unless it has been
conclusively demonstrated to be so through extensive testing that includes
toxicological feeding studies using the whole food.

·        However, the FDA¹s politically appointed administrators ­ operating
under a White House directive ³to foster² the biotechnology industry ­
covered up these warnings, professed themselves ³not aware of any
information² showing that GE foods differ from others, and allowed GE foods
to be marketed without any testing by claiming there is an overwhelming
consensus among experts they are safe.



I offered to give you documents I had prepared that summarized the concerns
of the FDA experts and quoted extensively from their internal memos, with
references to photocopies of the originals that are on our website
www.biointegrity.org   You asked me to hand them to your assistant, Dusky
Terry.  In the packet, I included a paper with a fuller explanation of the
health risks of GE foods and statements from numerous other experts who have
cautioned about them.



Shortly thereafter I phoned Dusky to follow up, and he informed me you had
asked him to give you all those documents and that they were in your
possession.  He assured me that you really do read the documents you ask
for.



In addition to what I told you in person, the documents you read alerted you
to the following facts:



a.         Although biotech proponents claim genetic engineering is
essentially the same as producing new crop varieties through conventional
breeding, the FDA scientists strongly disputed this claim and stated it
entails different risks, especially the risks of producing unintended and
essentially unpredictable new toxins, carcinogens and allergens that are
difficult to detect.



b.         The pervasiveness of this view within the scientific staff is
attested by a memo from an FDA official stating: "The processes of genetic
engineering and traditional breeding are different, and according to the
technical experts in the agency, they lead to different risks."



c.         This view is shared by numerous other experts who are not funded
by the biotech industry, and hundreds have issued warnings about the risks
of GE foods, including professors of molecular biology from Harvard, M.I.T.,
and the University of California, Berkeley.  Professor Philip Regal, a
renowned expert in plant genetics at the University of Minnesota, has
written: " there are scientifically justified concerns about the safety of
genetically engineered foods, and some of them could be quite dangerous.²



d.         A report issued February 5, 2001 by an expert panel of the Royal
Society of Canada states it is ³scientifically unjustifiable² to presume
that GE foods are safe.  It says the ³default prediction² for every GE food
should be that unexpected and potentially harmful changes have occurred; and
it concludes that the current approach to testing cannot adequately screen
for such unexpected alterations.  In the words of the Toronto Star:  ³The
experts say this approach is fatally flawed  .²



e.         In the U.S., the FDA does not even require this flawed system of
testing.  Rather, it presumes all GE foods are safe based solely on its
claim that there is an overwhelming consensus among scientists that they are
safe ­ a claim that clearly is not only false but fraudulent.  It persists
in this practice despite the fact the U.S. Food, Drug and Cosmetic Act
requires such new foods to be demonstrated safe through scientific
procedures, even if there is unanimous consensus about their safety.



f.           There is no reliable, peer-reviewed evidence that even one GE
food has satisfactorily completed the type of safety testing process that
the FDA experts as well as those of the Royal Society of Canada have
determined to be necessary.



g.         Even though the tests to date have been inadequate, they have
frequently yielded problematic results. For instance, there is mounting
evidence of GE plants with substantial ­ and unexpected ­ alterations in
chemical composition.  In 2000, the Public Health Association of Australia
(PHAA) analyzed Monsanto¹s data on three GE plants (herbicide resistant corn
and canola, and pesticide-producing corn) and in all three cases discovered
several statistically significant differences in chemical composition from
the non-GE counterpart.  The PHAA report states that the differences cannot
be attributed solely to the known products of the inserted genes and
cautions that these plants may contain unexpected ­ and to date unidentified
­ new substances that could be harmful to humans.  Further, recent
investigation by Japanese scientists reveals that Monsanto¹s data on its
³Roundup Ready² soybean, the most widely planted GE crop, shows important
differences between the GE bean and its conventional counterpart.  For
example, after standard heat processing of both the GE and non-GE beans, the
concentrations of three harmful substances were significantly higher in the
GE samples.  Many tests on other GE foods have likewise revealed chemical
alterations that are statistically significant ­ and potentially hazardous.



Somehow, in your enthusiasm to promote genetically engineered foods, you
have disregarded this evidence, even to the extent of making statements that
are fully at odds with it.  For instance, the standard form letter you send
to Iowans who write you with concerns about GE foods declares: ³Let me
assure you that federal agencies are rigorously involved in determining that
these products are indeed safe.  The Food and Drug Administration tests for
toxins and allergic reactions to genetically altered food  .²[ii]  And the
website of the Governors Biotechnology Partnership proclaims that it ³stands
firmly behind the proven safety and ongoing benefits of biotechnology.²[iii]
(emphasis added)  However, as the evidence you possess clearly shows: (a)
the FDA does not perform any safety testing on GE foods; (b) it does not
require the manufacturers to do any safety testing on them either ­ contrary
to the advice of its own scientific staff; and (c) no GE food has been
proven safe through the testing that the FDA¹s experts said is necessary.



Governor Vilsack, you have stated that your goal is to increase public
understanding of biotechnology.  If you truly desire to do so, it is
essential for you



·        to correct the false statements you have made regarding
biotechnology (including those that are on the Governors Biotechnology
Partnership website) and to issue a public retraction

·        to disseminate to the public a fair report on what the FDA¹s
scientific experts actually said about the hazards of GE foods and to
acknowledge that the FDA does not regulate these foods at all ­ a fact that
the FDA has admitted in a document it filed in federal court

·        to sponsor a public debate on the risks and benefits of GE foods,
with special emphasis on the food safety issue, at which I will appear along
with any proponent of biotechnology that you select.



I hope you will soon set the record straight, and I will be happy to serve
as an advisor to assure the accuracy of statements you make about
biotechnology in the future.










[i] The report on the meeting in the Ottumwa Courier, June 1, 2001 describes
the nature of my communication to you.
[ii] From a letter you sent to a concerned Iowan dated June 13, 2002
[iii] This statement is still on the Partnership¹s website as of  September
4, 2002.

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