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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

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 FDA's 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 FDA's 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 FDA's politically appointed administrators - operating under a White House directive 'to foster' the biotechnology industry -covered up these warnings, professed themselves 'not aware of any information' 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.

An Open Letter to Governor Thomas J. Vilsack (continued)

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 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."

  • d.  A report issued February 5, 2001 by an expert panel of the Royal Society of Canada states it is 'scientifically unjustifiable' to presume that GE foods are safe. It says the 'default prediction' 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: "The experts say this approach is fatally flawed."

  • 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 Monsanto's 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 Monsanto's data on its 'Roundup Ready' 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: "Let 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." [ii] And the website of the Governors Biotechnology Partnership proclaims that it "stands firmly behind the proven safety and ongoing benefits of biotechnology." [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 FDA's 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 FDA's 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 Partnership's website as of September 4, 2002.

Related links:  

FDA's Letter to Oregon Gov. Kitzhaber on labeling (Measure 27)

Steve Druker's response to the Governor exposing the FDA's inaccuracies.


The Oregon GE Food Labeling Initiative in Hindsight

November 6, 2002

Dear Friends,

The bottom line is that we threw the biotech industry a bone and they jumped off the edge of a cliff to grab it. They'll be smiling all the way down.

Measure 27 was great success thanks to all the people working on the GE issue for so many years. The ground was extremely fertile. I have been waiting to post this update thinking that the news articles would end and the election results would be final. But more and more articles have been posted throughout the day and the results are not final so I'll go ahead and post this. So far the news today has been carried by AP, Reuters, Reuters (UK), Forbes, CNN had it as one of the "key ballot measures", Oregon media and other media outlets scattered about the country.

In all honesty, we can be thankful that Measure 27 did not pass because it was only a rough draft and not as well written as other optional versions. We had to make the effort to win because it was on the ballot. It did have serious flaws that might have worked against us and ultimately the consumers if it did not get corrected in the legislature. More on that below.

  1. Re: Vote results - Most articles say Measure 27 ended up 28% "Yes" to 78% "no". Washington Times said 36% "Yes" and 64% "No" but I think the lower numbers will be correct in the end.

    This is actually quite good for the first time in the arena. The Democratic candidate for Oregon Senator got only 39%. Two other initiatives got even less than Measure 27. Universal healthcare was 21% yes to 81% no. Another on lowering the age for becoming a state legislator was 24% yes to 76% no. We can be glad that minimum wage was raised. But "In education, nearly all school bonds were defeated. ...Voters overwhelmingly turned down the bonds, despite budget cuts in those schools."

  2. Reasons for losing at the polls and why it was OK to lose - These can also be taken as suggestions for revising a labeling initiative.

    a. Cost - Oregonians did not vote against labeling of GE foods as much as vote against an uncertain cost impact and a less well written initiative than it could have been. The research on costs had less benefit that it could have because of the ambiguities in the Measure and because the research came out late in the campaign and there was not enough money or time to educate people about it.

    b. Need for safety testing - Labeling without pre-market safety testing labeling alone is potentially counter-productive in that it means the untested stuff is still out there. Labeling could have affected the market and incentives for growing GE crops but whether it would have overcome the risks is not certain.

    c. Need a better precedent - If any labeling law is going to set a precedent, it should not be Measure 27. Because of the number of ambiguities, by the time it cleared the court and the legislature's ability to change it, there might not have been much of a useful initiative left.

    d. Threshold - The threshold used in Measure 27 was "one tenth of one percent of the weight of the product" but in initiatives filed in Colorado, Washington, Florida and maybe California, it was "one tenth of one percent of any ingredient or component in the product by weight". That is a huge difference.

  3. Less useful label - It would be better if each GE ingredient was identified as we saw in the Heinz package. That would provide the kind of useful information that would benefit consumers more.

  4. Definitions - A new definition of GE food is needed so that the varieties of wheat and other crops that are changed chemically, but not through recombinant DNA technology, would not be subject to the labeling. Whether they would have been under Measure 27 was questionable among the experts.

  5. Deadline - The 90 day deadline through off people. It could have been interpreted in a way that did not require labeling to actually start in 90 days but is was not clear. There should be provisions clearly stated for staging the application of provisions perhaps in the same way that was done in the National Organic Standards.

  6. Burden of being first - It's understandable that under that current economic difficulties Oregonians would not want to risk too much on an unknown law. It will help to have bills introduced in many legislatures at the same time in the upcoming session, not because we really expect them to pass, but to keep the momentum going and to support national labeling. It is reasonable that labeling be done nationally but voters don't realize how effective the biotech industry has been in preventing it. Time will tell on this issue.

  7. "No" is Default vote - When in doubt people are likely to vote no. If the initiative had been written in such a way that a "no" vote would require labeling, then the opposition would have had the burden of convincing voters otherwise and that is harder and costs more.

There were organizations who supported labeling in general but could not bring themselves to endorse and campaign for this particular measure, given its weaknesses. Nevertheless, they encouraged the continued discussion of the issue and recognized its importance of it and offered to work with proponents to get it right next time or in the legislature.

Other recommendations for the future.

  1. Oregon will now be much harder because one initiative that did pass prohibits paying petitioners by the signature and allows only paying them an hourly wage and it seems requires making them employees! That is really going to complicate things. Local efforts are strongly encouraged.

  2. Read "Citizen Lawmakers" by David Schmidt. It has just about everything you need to do a ballot initiative and get up to speed on certain strategies. You don't have to be a professional. Initiatives are clearly something that activists need to do more of. It is a powerful tool and weapon but has to be used properly. It is far better that activists learn how to do ballot initiatives than to have professional ballot initiative campaigners take the first step and file initiatives and then go to the activists and potential campaign funders. I have seen this now in three states so it is a good recommendation to remember.

Measure 27 was a great milestone in the GE issue. Just about every voter, Chamber of Commerce, non-profit organization, religious organization, labor organization, school, etc. was discussing this issue and coming to some decision on it. Just engaging that many people in the discussion was a good enough reason to try this approach.

Measure 27 was one of the most watched ballot initiatives in the country and now the international coverage has allowed more of the world's population to know that Americans have not "embraced" biotechnology and that we are battling the same U.S. corporations they are.

Thank you again for all your support and for not minding so much that I hogged the listserve for a couple months. It was just too tempting to share the heartfelt sentiments of so many ordinary people speaking out for Measure 27 in so many unique ways. It was completely real and down to earth. This is the hope for much of what is wrong in this country. We the People are going to have to set it straight. Now that a corporate-controlled party has commandeered all branches of the government, I don't think we can expect much from Washington D.C.

Good luck in all your campaigns.
Jeff Peckman


Europe Backs Stricter GM Rules

3 July, 2002

Plans to enforce stricter labelling of genetically modified foods across the European Union have been agreed by members of the European Parliament. Under current EU rules, only food with more than 1% of GM material has to be labelled.

The proposals, which still have to be agreed by EU environment ministers before becoming law, would include the labelling of GM derivatives in such products as sugar and oils.

But the parliament failed to agree on extra measures demanded by some MEPs to label milk, meat and eggs from animals reared on genetically modified feeds.

The European Commission believes stricter labelling could help dispel the notion that the biotechnology industry has something to hide.

But those involved in the industry say the proposed rules would set them back by decades.

For the last four years, there has been an effective moratorium across the EU on the commercial growing of genetically modified crops.

Public anxiety about the technology has meant research has come to a virtual standstill.

The new legislation may give consumers more information, but the BBC's Shireen Wheeler says it could also lead to a trade dispute with the United States, where the export of genetically-modified crops and products is worth billions of dollars. Five bills introduced in the House of Representatives to provide a comprehensive regulatory framework.

EU Updates:

EU Agriculture Ministers Achieve Breakthrough on Transgenic Food Labeling

(Thursday, Nov. 28, 2002 -- CropChoice news) -- Associated Press: European Union agriculture ministers clinched a breakthrough Thursday to end months of dispute over the labeling of genetically modified food.

The 15 ministers approved by a majority decision that 0.9 percent of biotech material can be in food or animal feed before it has to be labeled as genetically modified. Danish Agriculture Minister Marian Fischer Boel, who chaired the talks, said, "We have taken an important step toward offering consumers a real choice when it comes to GMOs."

For most of Thursday, seven EU nations were holding out for a 0.5 percent threshold and the rest seeking 1 percent. In the end, the opposition of Britain, which sought a one-percent threshold, and Luxembourg and Austria, which wanted more stringent limits, could not stop the measure from being approved. German Consumer Minister Renate Kuenast said, "This is a major step forward for consumers."

Now, the ministerial agreement goes back for approval to the European Parliament, which has previously pushed for the lower limits of genetically modified food content.

EU Environment Ministers Agree On GMO Labeling Package

European Commission Delegation in Washington DC
EU News Release
No. 69/02 December 10, 2002

EU Environment Commissioner Wallström welcomes progress toward legislation on GMO labeling and traceability

European Environment Commissioner Margot Wallström welcomed yesterday's agreement on a common position for a Regulation on traceability and labeling of GMOs and traceability of food and feed products produced from GMOs.

Commissioner Wallström commented:

"The people of Europe want to be fully informed about the use of GMOs in food and feed. It is our responsibility as policy makers to show strong political leadership and do what is necessary to ensure a high level of environmental protection as well as safety and consumer choice. This is essential if Europe is to reap the potential benefits of GMOs and biotechnology."

"If we are to make acceptance of GMO products possible in the European Union then we must restore public and market confidence. In order to do so, we must provide consumers with an effective choice between GMO and non-GMO products. Labeling and traceability of GMO products will enable them to choose".

EU Directive 2001/18/EC on the deliberate release into the environment of GMOs was fully applicable on 17 October 2002. The Directive provides the foundation for approval of new GMOs under a more stringent, efficient and transparent authorization procedure and requires Member States to ensure labeling and traceability. Agreement today means that these national measures will be replaced by common measures throughout the EU under this proposal when it takes effect.

The text agreed in yesterday's meeting of EU environment ministers provides that:

  • Products containing GMOs that are to be made available to consumers will always have to be labeled as such.

  • When operators, throughout the production and distribution chains, are handling products that contain GMOs they will have to provide this information to the next operator in the chain providing for traceability.

  • Operators will have to list the codes of individual GMOs, in accompanying documentation, that have been used to constitute the original mixture of raw material intended for food, feed and processing. Implementation of this requirement will be revisited no later than two years from the date of entry into force of this Regulation.

  • The accidental presence of minute traces of GMOs in products for food, feed and processing is addressed using coherent and consistent thresholds.

  • A clause to ensure that the Regulation meets its objectives and is operational and, enforceable.

Press Contacts:
Willy Helin - (202) 862-9530
Maeve O'Beirne - (202) 862-9549
Wilfried Schneider - (202) 862-9523


The National Catholic Rural Life Conference (NCRLC) is calling for labeling and greater precautions in the commercial use of genetically engineered crops. The Campaign is excited that the NCRLC is joining the many other organizations nationwide that are calling for GE food labeling.

NCRLC Calls for Moratorium on Commercial Use of Biotech Seeds and Plants

June 2002

The Board of Directors of the National Catholic Rural Life Conference renewed their grave concern about the use of genetically engineered seeds and plants during their June meeting in Yakima, Washington.

Board members approved a statement called "Agricultural Biotechnology: A Catholic Perspective" that is distinctly apprehensive about genetically engineered plants and animals in the U.S. food and agriculture system. The board of the National Catholic Rural Life Conference (NCRLC) called for a precautionary approach to this radically new technology. The statement specially calls for "a moratorium on the commercial introduction of genetically engineered crops until a principled food policy is developed through public debate." The board also agreed that foods with genetically engineered ingredients should be labeled for the awareness and benefit of consumers.

Br. David Andrews, CSC, executive director of NCRLC said that the controversy about genetic engineering in agriculture is not going away anytime soon. "Agribusiness companies are treating biotechnology as a natural next step in the history of agriculture. However, the public needs much more discussion about this new technology and its potential impact on human health and the environment." NCRLC is calling on policymakers to hold public forums and directly address some of the scientific and ethical questions raised by agricultural biotechnology.

There is also concern among NCRLC board members about the control of seeds and other inputs by biotechnology firms. "Wheat farmers are deeply troubled about the introduction of biotech wheat in the Great Plains and the potential loss of export markets to countries refusing genetically modified foods," said Christopher Dodson, NCRLC board member from Bismarck, North Dakota. An agricultural system that is able to separate genetically modified seeds and plants from other agricultural crops is not yet in place, and may be impossible to create in a mass market system, Dodson said.

Contact: Robert Gronski, NCRLC policy coordinator; 515-270-2634;

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