UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
ALLIANCE FOR BIO-INTEGRITY, et al.
Plaintiffs
v.
DONNA SHALALA, et al.
Defendants.
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.
[signed]________
Dr. Richard Lacey