Alliance for Bio-Integrity, et al. v. Donna Shalala, et al.
May 28, 1999
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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ALLIANCE FOR BIO-INTEGRITY, et al.
DONNA SHALALA, et al.
Civil Action No. 98-1300 (CKK)
DECLARATION OF PHILIP J. REGAL, Ph.D.
I, Philip J. Regal, state:
l. I am a biologist in the College of Biological Sciences and am Professor of Ecology, Behavior and Evolution at the University of Minnesota (St. Paul), where I have been on the faculty since 1970.
2. I have made several important contributions to the study of plant biology, particularly in the area of how genetics relates to adaptability and organization of organisms. I have nine publications on this particular topic among my contributions to the peer reviewed scientific literature. (A list of my publications and key presentations is attached.)
3. Since 1983, I have closely studied various safety issues concerning the use of recombinant DNA technology (RDNA technology; genetic engineering) to develop new plant varieties. My involvement has been both intensive and extensive. I have attended and sometimes organized scientific biosafety workshops for government agencies and scientific societies, presented at conferences, and published articles on agricultural genetic engineering in the scientific literature. I have consulted for and worked closely with government regulatory agencies, Congressional staff, scientific organizations, private corporations, and public interest groups.
4. It is my professional opinion that utilizing RDNA technology in production of food-producing organisms can be very powerful biologically and very different biologically from conventional forms of breeding. It entails a set of risks to human health that are not ordinarily associated with the latter. Such use of RDNA technology has the well-recognized potential to interfere with the normal activities of the engineered organism, for example so as to generate unexpected and unknown toxins, carcinogens, allergens and other anti-nutritive substances.
5. My own analyses, as well as a substantial body of published research, clearly establish that these types of unintended side effects are risks that cannot be lightly discounted. Moreover, although I have kept abreast of developments in biotechnology and have regularly read the relevant scientific literature, I am not aware of any reliable study published in the peer-reviewed scientific literature which demonstrates that these risks are categorically either (1) negligible or (2) no greater than in the case of conventionally produced organisms. Nor am I aware of even one such peer-reviewed, professionally published study which has detailed scientific criteria for testing and evaluation and gone on to demonstrate that even one particular genetically engineered food is reasonably certain to produce no harm when eaten by a human being.
6. Rather, it is my considered judgment that the evidence to date, in its entirety, indicates there are scientifically justified concerns about the safety of genetically engineered foods and that some of them could be quite dangerous. Further, in the absence of reliable toxicological tests, it is not possible to determine which of these new foods are dangerous and which are not.
7. It is also my observation that there is not general recognition of the safety of genetically engineered foods among those members of the scientific community qualified to make such a judgment. In fact, it has been my personal experience over numerous years that many of those experts who publicly subscribe to the position that these foods are as safe as their natural counterparts privately admit they have serious doubts. For instance, when I attended a conference on biotechnology in Annapolis, Maryland in 1988, at which many officials from federal regulatory agencies (including the FDA) were present, I was shocked to learn the extent of uncertainty. In informal discussions at meals and on walks, government scientist after scientist acknowledged there was no way to assure the safety of genetically engineered foods. Several expressed the idea that, in order to take this important step of progress, society was going to have to bear an unavoidable measure of risk.
8. Consequently, I am deeply troubled by the FDA's decision to permit the widespread marketing of untested genetically food products based on a stated presumption they are, in the general case, equivalent to, and thus are as safe as, their natural counterparts. As I have pointed out, there is no sound scientific basis for such a presumption and the weight of the evidence is against it. It is my considered opinion that such a presumption can only be made by systematically ignoring a large body of solid and relevant evidence.
9. To support its policy, the FDA appears to claim that if a gene from one species is forcibly and with only variable precision implanted into the DNA of a distant and dissimilar species, we can reliably assess the safety of the new organisms merely by analyzing the known characteristics of the two species and of the specific substance(s) that it was intended the foreign gene would produce. One prop of this argument is the notion that (1) if the substance produced by the foreign gene is substantially similar to a substance that is generally recognized as safe and (2) if the organisms of the target species are already generally recognized as safe to eat, then the genetically engineered organisms will also be safe -- assuming we observe no obvious change in key constituents or superficial qualities of taste or texture.
10. This notion is grossly at odds with biological reality. It is well known that science cannot reliably predict how a given substance will act within a genetic and cellular environment that is quite foreign to it. Not only could the chemical attributes or behavior of the foreign substance markedly change, but its very presence could alter important behaviors of the host cells. Moreover, the process of implanting the foreign gene that produces that substance could in itself disrupt cellular metabolism in numerous ways. Genetic vectors, markers, and regulatory bits of code are also commonly added along with the foreign gene, to further complicate uncertainties. To ignore the fact that the living systems involved have complex biochemical and developmental dynamics and that unusual high-technology genetic interventions have the real potential for unpredicted deleterious side effects is, at best, biologically naive.
11. However, while it might be no more than naive for a layperson to make such simplistic assumptions, it is otherwise in the case of a government regulatory agency that has been repeatedly informed of the facts. When such an agency persists in ignoring these facts, even though the safety of the food supply is at stake, its behavior is not merely scientifically unsound but morally irresponsible.
12. It is because I view the FDA's policy and practices regarding genetically engineered food to be irresponsible -- and because I regard the consequent risk posed for public health to be substantial -- that I have taken the step of joining the above-named lawsuit as a plaintiff. By standing as a plaintiff rather than merely participating as an expert witness, I hope to make clear to the public and the Court not only the extent to which I disagree with the agency's assumptions as a purely intellectual matter, but the degree to which I deplore its behavior on ethical grounds. Ultimately, I was compelled by my conscience to become a plaintiff, and I am proud to stand with so many other scientific experts who have similarly acted on the basis of ethical as well as strictly scientific principles.
13. In accordance with 28 U.S.C. sec. 1746, I declare under penalty of perjury that the foregoing is true and correct.
Executed on: May 28, 1999
Philip Regal, Ph.D.