This is a statement on the health risks of using genetic engineering in producing new plant varieties for food. It is by Dr Richard Lacey, an expert on food safety, who foresaw the BSE (mad cow disease) food crisis.

This legal declaration was made in May 1999, in the course of a lawsuit by the Alliance for Biointegrity and others (including eminent scientists, health professionals and religious leaders) against the US Food and Drug Administration for allowing the marketing of genetically engineered food without requiring mandatory safety testing and labelling.

Doc. TWN/Biosafety/2000/C

Legal Declaration of Dr Richard Lacey on Food Safety Aspects of GE Crops








Civil Action No. 98-1300 (CKK)

DECLARATION OF Dr. Richard Lacey, M.D., Ph.D.

I, Richard Lacey, state:

1. I reside at [          ] Leeds, UK.

2.   I earned both a B.A. in biochemistry and an M.D. from the University of Cambridge and a Ph.D. in genetics from the University of Bristol. Since 1971, I have been a member of the Royal College of Pathologists, and since 1983, I have been Professor of Medical Microbiology at the University of Leeds. (I have been on Emeritus status since 1995.)

3.   I am an expert in food safety issues, and my background makes me especially qualified to assess the potential risks of genetically engineered food products. I served four years on a U.K. government advisory panel on food as it relates to human and animal health, and I have written five books on food safety, including one published by Cambridge University Press in 1994 containing a detailed discussion of genetically engineered food. (This book has been translated into Japanese and Polish.)In addition, I have written over 200 articles published in standard scientific journals and attended and spoken at numerous scientific conferences both in the U.K. and abroad. (A list of my publications and honors is attached.)

4.   In 1989, I anticipated that there could be serious health risks to the British cattle and human populations from the practice of feeding cattle rendered meat from sheep and other animals. I published my warnings in Food Microbiology, 1990. In this article, I explained the nature of the malady that could result. This was the first prediction of what eventually became the “mad cow” epidemic in the United Kingdom. Unfortunately, the governmental authorities were slow to respond to my warning. Had they properly assessed and acted upon the information I presented, much hardship would have been avoided, and the citizens would not have been subjected to as high a degree of risk.

(Because of the long latency period between exposure to the infectious agent and development of symptoms, there is a potential for widespread incidence of infection within the British public over the next forty years.)

5.   It is my considered judgment that employing the process of recombinant DNA technology (genetic engineering) in producing new plant varieties entails a set of risks to the health of the consumer that are not ordinarily presented by traditional breeding techniques. It is also my considered judgment that food products derived from such genetically engineered organisms are not generally recognized as safe on the basis of scientific procedures within the community of experts qualified to assess their safety. Paragraphs 6 through 10 explain why these new foods entail higher risks, and paragraphs 12 through 15 explain why none of them is generally recognized as safe.

6.   Recombinant DNA technology is an inherently risky method for producing new foods. Its risks are in large part due to the complexity and interdependency of the parts of a living system, including its DNA.

Wedging foreign genetic material in an essentially random manner into an organism’s genome necessarily causes some degree of disruption, and the disruption could be multi-faceted. Further, whether singular or multi-faceted, the disruptive influence could well result in the presence of unexpected toxins or allergens or in the degradation of nutritional value. Further, because of the complexity and interactivity of living systems—and because of the extent to which our understanding of them is still quite deficient—it is impossible to predict what specific problems could result in the case of any particular genetically engineered organism. Prediction is even more difficult because even when dealing with one variety of a food-producing organism and one particular set of foreign genetic material, each insertion event is unique and can yield deeply different results.

7.   The mechanics and risks of recombinant DNA technology are substantially different from those of natural methods of breeding. The latter are typically based on sexual reproduction between organisms of the same or closely related species. Normally, entire sets of genes are paired in an orderly manner that maintains a fixed sequence of geneticinformation. Every gene remains under the control of the organism’s intricately balanced regulatory system. The substances produced by the genes are those that have been within the species for a long stretch of biological time. (In cases where mating is between closely related species, there is generally close correspondence between the substances produced by each.) In contrast, biotechnicians take cells that are the result of normal reproduction and randomly splice a chunk of foreign genetic material into their genome. This always disturbs the function of the region of native DNA into which the material wedges. Further, the foreign genes will usually not express within their new environment without a big artificial boost, which is supplied by fusing them to promoters from viruses or pathogenic bacteria. As a result, these genes operate essentially as independent agents outside the host organism’s regulatory system, which can lead to many deleterious imbalances. Moreover, this unregulated activity produces substances that have never been in the host species before and are usually very different from any that have—which could lead to problems even if production were at a low rather than a high level. There are several other major differences between genetic engineering and traditional breeding, all of which could, as can the above-mentioned ones, induce the presence of unpredicted toxins or allergens or the degradation of nutritional value.

8.   Consequently, whereas we can generally predict that food produced through conventional breeding will be safe, we cannot make a similar prediction in the case of any genetically engineered food.

9.   Therefore, the only way even to begin to assure ourselves about the safety of a genetically engineered food-yielding organism is through carefully designed long-term feeding studies employing the whole food; and it would be necessary to test each distinct insertion of genetic material, regardless of whether the same set of genetic material in the same type of organism has previously been tested.

10. Even if the most rigorous types of testing were performed on each genetically engineered food, it might not be possible to establish that any is safe to a reasonable degree of certainty, as is possible in the case of most ordinary chemical additives. However, we at least would be in a far better position than now to have greater confidence in these new foods.

11. I regularly attend professional conferences in my specialities and I keep abreast of the scientific literature. I also stay in communication with many life scientists and health professionals.

12. To the best of my judgment, neither genetically engineered foods as a general class nor any genetically engineered food in particular is generally recognized as safe among those experts qualified by training and experience to evaluate their safety.

13. I base this judgment on two factors. First, although many life scientists (including some molecular biologists) claim that genetically engineered foods pose no unreasonable risk, I know of many well-qualified life scientists who do not think that their safety has been established.

For instance, a recent official statement of the British Medical Association seriously questions the assumption that genetically engineered foods are in general as safe as those produced by traditional methods. In my opinion, the number of scientists who are not convinced about the safety of genetically engineered foods is substantial enough to prevent the existence of a general recognition of safety. Second, there is insufficient evidence to support a belief that genetically engineered foods are safe. I am not aware of any study in the peer-reviewed scientific literature that establishes the safety of even one specific genetically engineered food let alone the safety of these foods as a general class. Few properly designed toxicological feeding studies have even been attempted, and I know of none that was satisfactorily completed. Those who claim that genetically engineered foods are as safe as naturally produced ones are clearly not basing their claims on scientific procedures that demonstrate safety to a reasonable degree of certainty.

Rather, they are primarily basing their claims on a set of assumptions that, besides being empirically unsubstantiated, are in several respects at odds with the bulk of the evidence.

14. The main assumptions are: (a) that producing food through recombinant DNA technology in itself entails no greater risks than producing it through sexual reproduction between members of the same species and (b) that the same safeguards commonly employed by breeders using conventional techniques will suffice for genetically engineered foods. As I have explained in paragraphs 6 and 7, the first assumption is unsound and at odds with biological reality. Paragraphs 8,  9 and 10 explain the unsoundness of the second assumption.

15. As far as I can ascertain, the current policy of the U.S. Food and Drug Administration is primarily based on these two assumptions. Therefore, although it claims to be “science-based,” this claim has no solid basis in fact. The only way to base the claims about the safety of genetically engineered food in science is to establish each one to be safe through standard scientific procedures, not through assumptions that reflect more wishful thinking than hard fact.

16. In accordance with 28 U.S.C. § 1746, I declare under penalty of perjury that the foregoing is true and correct.

Executed on: May 28, 1999.


Dr. Richard Lacey