-Caveat Lector-

From: "Hilary A. Thomas" <[EMAIL PROTECTED]>


[Note: This document (in html format) is formatted to closely resemble the
original, with the same wording. This is not a photocopy, which accounts
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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)
<P.  DECLARATION OF  Dr. Richard Lacey, M.D., Ph.D.


I, Richard Lacey, state:

1. I reside at Carlton Manor near Yeadon, Leeds, 197BE, United Kingdom.

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 genetic information.
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

<http://www.biointegrity.org/Laceydeclaration.html>


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