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Genetically Engineered Food and the US FDA

Genetically Engineered Food and the FDA: Interview with Steve Druker

Interviewed By Sean Weaver

First published: Organic NZ May/June 2001, pp 8-9.

"The FDA scientists sound just like our plaintiffs. Memorandum after memorandum, - - all of these different sections who were participating in the Biotechnology Task Force, overwhelmingly told the bureaucrats at the FDA that you cannot assume that genetic engineering is the same as conventional breeding - it's very different and it leads to different risks."

Steve Druker, Director of the Alliance for Bio-integrity in the United States, has become a big name in the global debate on genetic engineering in recent years through his efforts to bring to pubic attention the way that the US Food and Drug Administration has dealt with the advice of its own scientists on the safety of GE foods. Steve was in New Zealand in January to give evidence at the Royal Commission on Genetic Modification, as a witness for GE Free NZ and the Nelson GE Free Awareness Group. SW. Steve, what brought you here to New Zealand?

S.D. I am here to testify before the Royal Commission and in particular to explain how the approval of GE foods in the US is based on systematic fraud by the Food And Drug Administration.

SW. Why was it important to come to New Zealand, what can New Zealand do for your campaign?

S.D. New Zealand is on the verge of allowing far more GE foods into the country. It's been pressured by the US and it's important that people here realise that US experts in the FDA said that GE foods entail unusual risks, they can't be assumed to be safe and they need to be comprehensively safety tested. This information was suppressed in my country, it's been covered up for years and has been lied about by the heads of the FDA.

SW. What difference could New Zealand make to all of this?

S.D. If New Zealand stands up and says “We won’t accept this food, and we don’t trust the US, in fact we're outraged that we are being pressured to accept such food, based on fraudulent claims,” this could have an impact on every country, just as New Zealand got tremendous attention for its stance on the nuclear issue. SW. What is the FDA saying that has an impact on countries like New Zealand?

S.D. Many countries around the world are citing the FDA as an authority on the safety of GE food. They say that the FDA has extensively safety tested these foods and has found them to be safe. The fact is, these foods haven't been safety tested and they haven't been proven safe. In fact, the FDA has established a regulatory regime that ensures GE foods are not tested. If the FDA has said these foods are safe, then other governments can say they are safe and in fact they have. The approvals of GE food to date in the European Union, Japan, Australia and New Zealand are, to a large extent, based on the fact that the FDA has said they are safe and do not pose a risk.

SW. What's the basis of the FDA position?

S.D. In the summer of 1992, the FDA published an article in Scientific American to justify the position it had just taken on GE food – claiming that they can be assumed to be safe. The basic premise is that new food varieties have been shown to be safe. That is the premise, and it's true if we're talking about conventional breeding. The FDA tried to conclude from this that all GE food can therefore be assumed to be safe. They never once demonstrated why one should think that GE is the same thing as producing things through conventional breeding.

SW. And the scientists?

S.D. This is where is gets interesting. Scientists who understand what's going on have said that because of the potential for disruption inherent in the process of GE, every GE plant could contain unintended and essentially unpredictable new substances. There can be such disruptions that the plant can produce not only the expression product that you can predict from the foreign gene, but also a whole range of other substances many of which can be poisonous, toxic, allergenic, or carcinogenic. And because these can be substances that have never before been seen in that species, in that organism, or in the species from which the genetic material was transferred, you can not rely on simple compositional or nutrient testing. You can't rely on simple chemical analysis to establish substantial equivalence – which is a bogus concept anyway. You can't rely on feeding studies that only feed the expression product and not the whole food, because there may be substances contained in the food product – not the expression product such as some insecticidal protein – but products that were not able to be predicted in the first place. One would have to do feeding studies with the whole food and they’d have to be long term toxicological studies. Any scientist that really deserved to be called a scientist cannot ignore this fact.

SW. But we're told so often that GE is more precise than conventional breeding.

S.D. We hear it again and again from biotech scientists. Those are doctors of science who are acting primarily as spin doctors. GE may be more precise compared with conventional breeding in one narrow respect, but this respect is not relevant to food safety. It probably is the case that the vast majority of geneticists and microbiologists are making these claims to the public, and yet at the same time they're saying “you need to let us educate you, to help you understand this complexity.” They're not here to educate you. They're here to confuse.

SW. What happened with the law suit? Were some of these issues raised or dealt with in any way?

SD. During the law suit the FDA had to furnish us with copies of its internal files, and we got over 44,000 pages of internal documents. What we found was that the scientific plaintiffs in our lawsuit and those hundreds of scientists that have raised concerns publicly in petitions and publications were not the only scientists talking about the unintended hazards of genetic engineering. You know, it's claimed that the FDA has done an extensive scientific review and found these foods to be safe. Well, actually, the FDA hasn't done a thorough scientific analysis. Its scientists haven’t done testing themselves. But they did have their own experts do a thorough review, just based on what was known about what GE is, and what it was likely to do. That review was undertaken between 1990 and 1992. And guess what? The FDA scientists sound just like our plaintiffs. Memorandum after memorandum, from the Toxicology Group, and the Molecular Biology Group and the Centre for Veterinary Medicine, and the Organic Chemistry section, all of these different sections who were participating in the Biotechnology Task Force, overwhelmingly told the bureaucrats at the FDA that you cannot assume that genetic engineering is the same as conventional breeding – it's very different and it leads to different risks. Among these risks are the risks of poisons, or carcinogens or other harmful substances that we may have never seen before in any of the species. And you'd have to include in the testing protocol, toxicological feeding studies using the whole food. The FDA was told this by its own scientists. And as I said, any competent scientist knows this stuff.

SW. Why did the FDA ignore its own scientists?

SD. The FDA had been given a directive by the Reagan Administration continuing into the first Bush administration. It continued into the Clinton administration – and I'd be amazed if the current President Bush didn’t continue it (or even make it worse). The directive was to promote the biotech industry and to develop a policy that GE was essentially the same as conventional breeding and that GE foods are to be assumed to be safe. They did this by saying that they would regulate the product – not the process.

SW. What do you mean by regulate the product and not the process?

SD. If you're only going to analyse the known expression product then you're going to miss the unknown and unintended by-products of an inherently unpredictable process. It's about establishing a regulatory system that ignores the fact that the technology itself produces unintended consequences resulting from transgene insertion and the disruption of the host genome. This genetic disruption is capable of producing physiological consequences in the GE plant, such as the production of toxins or carcinogens, or anti-nutrients – consequences highly relevant to food safety, and yet it will not be subject to testing. It will not require the screening or testing for these unintended effects that scientists all around the world, including the FDA’s own scientists, are concerned about. The FDA is pretending that this whole range of existing or potential unintended side effects simply does not exist. And the biotech scientists want you to believe that they don’t exist either.

SW. And what did the FDA’s own scientists actually say?

SD. I’ll give you a few examples. A molecular biologist with the FDA wrote in a memo that "there is a profound difference between the unintended consequences of genetic engineering and traditional breeding", and he added that "some aspects of gene splicing could be more hazardous" – those were his words. One of the most important documents is from the Director of the Centre of Veterinary Medicine speaking on behalf of the whole centre. There are a lot of scientists in this centre – experts in animal feeds, who are interested in how safe animal feeds are when they contain GE ingredients. He stated that their conclusion is that feeding animals with plants that have been genetically engineered poses unique animal and human food safety concerns. He stated that, most of the time animals will be eating much higher proportions of GE food than humans. This is because humans will be mixing our intake of GE foods with non-GE foods. But animals are eating GE foods all the time such as the grains and GE soya meal. Forty to sixty percent of their diet could be GE soya, or maize, or cotton seed mash. And he said that, therefore, even minor fluctuations in toxic components might become a problem for the animal. He added that these toxins could become concentrated in certain tissues, organs or animal products such as eggs or milk which may then be eaten by humans who could then be getting a much higher dose. Other FDA scientists warned that GE plants were capable of producing products that have not been found in either the target species or the species from which the gene was taken, and for this reason you'd have no way of predicting them. The only way to find these things was to do comprehensive toxicological testing which is not being done and not required. So uniform and so predominant was the feeling of the FDA experts that we are dealing with something very different which has to be treated differently, that the FDA compliance officer stated in a memo to the biotechnology co-ordinator in January 1992 that "the agency is trying to fit a square peg into a round whole by trying to ‘force an ultimate conclusion' that genetic engineering is essentially the same thing as conventional breeding". She went on to say that the processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.

SW. What happened as a result? Did the FDA use this information in any way?

S.D. The final policy statement that came out in May of 1992 had no statements from the FDA scientists about there being any difference between GE foods and those produced from traditional breeding. It said there is an overwhelming consensus among the scientific community that these foods are safe. They were not even recognised as safe within the FDA’s own scientific community. They stated that the processes are essentially the same. And then they went on to say – and this is very important because it points to the fraud – that the FDA is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way. Their own files are full of information that contradicts this statement. This is the fraud. They do have this information. They are aware of it. It is a lie. Fraudulent misrepresentations.

SW. What about the foods that are already on the market in the US and elsewhere?

SD. There is not a single GE food on the market that has been demonstrated to be safe by the proper scientific methods capable of establishing this. If the FDA in 1992 had told the truth, if it had said something like “Well our scientists say these foods do entail unique risks and every one of them is going to have to go through years of comprehensive safety testing” – that would have been the end of GE foods right there. This is because the economics of the food industry are not such that 12 to 18 years of safety testing would stack up. The investors would have abandoned the project. If the FDA had told the truth, it would have raised concerns all around the world. If they had told the truth, you wouldn’t now be eating GE foods right here in New Zealand.

The web site for the Alliance for Bio-Integrity is w Those who are interested can view scanned photocopies of original FDA memos that were revealed in the law suit showing what the FDA scientists were saying.


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