ngin - Norfolk Genetic Information Network

12 October 2002

MISREPRESENTATIONS IN FDA LETTER TO OREGON

A letter from Lester Crawford, deputy commissioner of the Food and Drug Administration and a former Executive Vice-President of the National Food Processors Association, has been sent to the office of Oregon governor John Kitzhaber. It strongly objects to Measure 27 which requires genetically engineered foods to be labeled in Oregon.

Below lawyer Steven Druker, who in the course of a lawsuit managed to force the FDA to reveal files containing the written opinions of its own scientific experts, writes to Oregon's governor to warn him that the FDA letter contains "several major misrepresentations" designed to give a false impression about GE food safety.

The lie to Crawford's letter which claims the "FDA is not aware of any information or data that would suggest that any genetically engineered foods that have been allowed for human use are not as safe as conventional foods", is given, Druker shows, by the opinions of the FDA's own experts, as well as by the opinions of eminent scientists outside the agency.

The Campaign to Label Genetically Engineered Foods has launched an ACTION ALERT towards FDA Deputy Commissioner Crawford: http://www.thecampaign.org/alert-fda.htm

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Alliance for Bio-Integrity exposes misrepresentations in FDA's letter to Gov. Kitzhaber

http://www.voteyeson27.com/druker_letter.htm

Alliance for Bio-Integrity
Preserving the Safety of Our Food, the Health of Our Environment, and the Harmony of Our Relationship with Nature
http://www.biointegrity.org
October 10, 2002

Governor John A. Kitzhaber, M.D.
State Capitol Building
900 Court Street NE
Salem, OR 97301-4047

Dear Governor Kitzhaber,

I wish to inform you that the letter you recently received from the Deputy Commissioner of the FDA contains several major misrepresentations that give the false impression there are no reasonable grounds for concerns about health risks of genetically engineered foods. In fact, such grounds do exist, and the FDA is well aware of them through extensive information provided by its own scientific staff. The following paragraphs explain some of the key misrepresentations and suggest how you can perform a valuable service to all Americans by speaking out on behalf of science and the truth on this important issue.

In his letter, Dr. Crawford asserts: "FDA is not aware of any information or data that would suggest that any genetically engineered foods that have been allowed for human use are not as safe as conventional foods." This assertion is made despite the fact the FDA's files contain numerous  memos from its own scientific experts informing it about the unique health risks posed by GE foods. The existence of these memos only came to light when a coalition of public interest groups and scientists headed by my organization filed a lawsuit against the FDA that forced it to divulge its internal files.

For example, Dr. Louis Pribyl of the FDA Microbiology Group wrote, "There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering..." He added that some aspects of gene splicing "..may be more hazardous."(4) (Numbers refer to  the document number in the collection of photocopies of twenty-four FDA documents on our website http;//www.biointegrity.org )

Dr. E.J. Matthews of the FDA's Toxicology Group warned that GE plants could contain unexpected toxins that could "...be uniquely different chemicals that are usually expressed in unrelated plants."(2) Citing the potential for such unintended dangers, the Director of FDA's Center for Veterinary Medicine (CVM) called for GE products to be demonstrated safe prior to marketing. He stated: "... CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns."(10) He explained that residues of unexpected substances could make meat and milk products harmful to humans.

These memos were written during the months before the FDA issued its May 1992 policy statement on genetically engineered foods. The pervasiveness of the concerns within the scientific staff is attested by a January 8, 1991 memo to the agency's biotechnology coordinator from an FDA official  responsible for monitoring the expert input. She stated: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (1).

Nevertheless, FDA political appointees - who admit they have been operating under a White House directive "to foster" the biotechnology industry - covered up their scientists' warnings and in their policy statement professed themselves "not aware of any information" showing  that GE foods differ from others in any meaningful way. They then allowed all GE foods to be marketed without any testing by claiming there is an overwhelming consensus among experts they are safe. They did so despite their knowledge that no such expert consensus exists outside the FDA  either - as evidenced by an October 23, 1991 letter from FDA's biotechnology coordinator to a Canadian health official. (8) To this day, FDA's false claim about scientific consensus remains the sole purported legal basis for the marketing of GE foods.

It is disappointing that Dr. Crawford has renewed the fraudulent claim that the FDA is "not aware of any information or data that would suggest that any genetically engineered foods are not as safe as conventional foods." It is especially troubling that he is employing this falsehood in an attempt to defeat an Oregon ballot initiative that would begin to restore the rights of consumers to have material information about genetic alterations made to the food supply. It is clear that the FDA has not only been denying American citizens the labeling that could supply some of this information, it has been intentionally deceiving them by misrepresenting the facts and covering up the concerns about health hazards raised by its own experts.

Dr. Crawford's letter further misrepresents the facts by stating: "FDA's scientific evaluation of bioengineered foods continues to show that these foods, as currently marketed in the United States, are as safe as their conventional counterparts."

This claim is quite curious in light of the agency's statement reported in The Lancet, May 29, 1999: "FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants - consistent with its 1992 policy." Since the FDA requires no testing of GE foods, acknowledges it does not conduct comprehensive reviews of them, and does not make formal empirical findings that particular GE foods are safe, it's amazing the agency would now claim its  evaluation process shows they are as safe as other foods. There is no scientific basis for such a claim. To the extent the FDA did a meaningful evaluation, its scientists concluded that GE foods entail unique risks.

The inadequacy of the FDA's approach to safety evaluation is further highlighted by Dr. Crawford's statement: "FDA's scientific evaluation to date has shown that the substances added to food via bioengineering have been well-characterized proteins that are functionally very similar to other proteins that are commonly and safely consumed in the diet every day."

Even if the substances that have been intentionally added to the engineered organisms may appear to be safe, they were not the main concern of the FDA scientists. Their primary concern was about the potential of the bioengineering process to generate unintended harmful substances that are difficult to predict and detect. Dr. Crawford's letter makes it clear that the FDA is disregarding this hazard and failing to monitor for unintended side effects. Consequently, he has no grounds for claiming the FDA has evaluated all the substances that have been added to food via bioengineering, since the agency is ignoring a major class of potential contaminants. This is one more reason his assertion about having demonstrated safety is bogus.

It's important to note that many other experts have expressed the same kind of concerns that were stated by the FDA's scientists.

For instance:

Professors of molecular biology at leading universities such as Harvard, M.I.T., and the University of California, Berkeley have issued cautions about the abnormal risks of GE foods.

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." See Declaration at www.biointegrity.org

The editors of the respected UK medical journal The Lancet have strongly criticized the presumption that GE foods entail no greater risks of unexpected effects than conventional ones. They state that there are "good reasons to believe that specific risks may exist" and that "governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health." Vol. 353, No. 9167, p. 1811 (May 29, 1999).

The Public Health Association of Australia analyzed Monsanto's data from controlled studies on  three of its GE plants (herbicide resistant corn and canola, and pesticide-producing corn) and in all three cases found several statistically significant differences in chemical composition between the GE organism and its non-GE counterpart. Their report (October 2000) 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.

The January 2001 report of the expert panel of the Royal Society of Canada states it is "scientifically unjustifiable" to presume that GE foods are safe. (p.ix) It explains that the "default prediction" for  any gene-spliced food organism is that "expression of a new gene (and its products)... will be accompanied by a range of collateral changes in expression of other genes, changes in the pattern of proteins produced and/or changes in metabolic activities."(p.185)

Accordingly, the report observes that novel toxins or other harmful substances could be generated (46-47; 184-85; 188-89) and notes the need for testing for short and long-term human toxicity, allergenicity and other health effects. It also notes that unless the whole food is tested, not merely an extract of the expected new substance(s), the assessment would be incomplete. (47)

(The FDA has been alerted to most of the above information through formal channels.)

Governor Kitzhaber, while in office you have consistently sought to protect the health of the public and of the environment. Hopefully, the information I have provided will stimulate you to issue a statement that can counter the misinformation the FDA has injected into this Oregon ballot contest and clarify the facts for the public. You may first wish to write Dr. Crawford and ask him to respond to a set of questions that can bring the truth into clearer focus. I suggest questions along the lines of those that follow.

Does FDA still maintain that genetically engineered foods are generally recognized as safe? (which as a matter of law, entails there must be an overwhelming consensus among scientists that they are so safe they require no testing, a consensus that must approach unanimity.) If so, how does the agency justify such a presumption in light of the fact that numerous experts have expressed the opinion that these foods entail added risks and must be rigorously tested to screen for unexpected side effects before they are marketed?

You have stated, "FDA is not aware of any information or data that would suggest that any genetically engineered foods that have been allowed for human use are not as safe as conventional foods." Please state whether you regard the memos written by the agency's scientific staff during  1990 - 92 explaining why GE foods entail different health risks than do their conventional counterparts as constituting "information."

If you do not think they can be categorized as information, how do you categorize them?

In its evaluation of GE foods, has the FDA made any formal determinations that particular products are safe according to the standard set by the Food, Drug and Cosmetic Act for foods containing new additives or has the agency merely reaffirmed its presumption that the food in question can continue to be presumed generally recognized as safe? If the former, please specifically list the foods so determined.

For every GE food that is either being marketed or has been the subject of a voluntary consultation with the FDA, please provide the evidence on the basis of which the agency claims that it has been shown to be as safe as its conventional counterpart.

On February 5, 1992 the Director of FDA's Center for Veterinary Medicine (CVM) sent a memo to the agency's biotechnology coordinator arguing that GE products should be demonstrated safe prior to marketing. He stated: "... CVM believes that animal feeds derived from genetically modified  plants present unique animal and food safety concerns." As a doctor of veterinary medicine, do you agree with this official position taken by the CVM when it was functioning in an objective, scientific capacity?

Has the CVM ever changed its position? If you say that it has, please provide the written record documenting such a change and the reasons on which it was based.

I further suggest that you note the importance of receiving his answers as soon as possible so you can complete your assessment in time to make a public comment while the citizens of Oregon are still in the process of deciding how to vote on Measure 27.

Please contact me if you desire clarification or elaboration of any of the points in my letter. I am scheduled to be in Oregon between October 13 and 25 and would be happy to meet with you and discuss this important issue in depth.

Best wishes to you and the citizens of Oregon for safe and nutritious food,

Steven M. Druker
Executive Director
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"There's something very American about it. People want the right to know. We're the country of  freedom of information." - Rep. Dennis Kucinich (D-Ohio), about labeling genetically engineered foods

For more statements by scientists on GE food safety:
http://ngin.tripod.com/foodstatements.htm

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