Proposal for Scientifically-based EC Toxicity Tests
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Proposal for Scientifically-based EC Toxicity Tests
Date:
Tue, 30 Jul 2002 09:03:38 -400
From:
Stephen Tvedten <steve@getipm.com>
Organization: Get Set Inc. (www.getipm.com)
To: Paul Helliker <phelliker@cdpr.ca.gov>
Director, State of California, Department of Pesticide
Regulation
cc: Christine Whitman whitman.christine@epa.gov
Dear Mr. Helliker, Joan Kilford <admin@dlrm.fsnet.co.uk> thought that you might be interested in the following. It is a Proposal paper by Dr Claude Reiss, Co-President of Doctors and Lawyer for Responsible Medicine (DLRM), President of Pro Anima.
Dr Claude Reiss is a world-class molecular biologist, with a distinguished professional back-ground, which includes many years' research experience, much of it spent with the French CNRS (National Centre for Scientific Research). His fields of research have included AIDS and Alzheimer's disease, with over 120 publications in peer-reviewed scientific journals. He is also the founder of the European Workshop in Molecular Toxicology. He is president of Comite Scientifique Pro Anima, the goal of which is to apply progresses in Sciences, and in biology in particular, to the benefit of human health and welfare, exclusively on consideration of science and logic.
Proposal for Scientifically-based EC Toxicity Tests
By
Dr Claude Reiss, International Molecular Toxicologist
Within the EU today, official statistics reveal that over one million people die prematurely every year as a result of consuming chemically laden products. Indeed, experts agree that 80 to 90% of cancers (one million casualties yearly in the EU) are attributable to carcinogenic chemicals present in the environment in which we live, and cancer is now the number one cause of death in people during the best years of their life (age 35 to 65). In addition, acute toxicity from prescription medicines (adverse drug reactions) stand now as the fourth leading cause of death in the EU, claiming 120 000 lives each year, a figure which could probably be doubled or even tripled if we include the longer term, or chronic, toxic effect of drugs.
Thus, a great number of everyday consumer products, and especially prescription medicines, have, in fact, not been properly evaluated, despite the extensive safety testing that the latter, in particular, have undergone. Since toxic risk assessment is carried out using animal models, as has happened over the past 100 years, one must conclude, therefore, that reliance on the animal model for the study of toxic effects in man, represents a clear danger to public health.
Was it really necessary to wait for a tragedy claiming millions of lives to occur, as described above, to begin to make us doubt the use of the animal model? In fact, the very idea that one species can serve as a model for a different species, demonstrates a complete lack of understanding of fundamental principles of modern biology. Any individual species is defined in terms of its reproductive isolation, which infers that its chromosomes cannot match, complement or recombine with those of any other species. Hence each species has a uniquely designed genome, i.e. the gene structure, the control and regulation of gene expression are all strictly species-specific. Since the genes determine all biological activities, it follows that the species’ response to any external stimuli, including toxic products, is strictly species specific also. No species can thus function as a biological model for another species, no matter how closely related they are phylogenetically (in evolution). This is specially true for toxic risk assessment.
Despite this evidence, the European Commission intends to rely on animal models for the toxic risk assessment of 100 000 chemical substances currently in use in EU countries. It is clear from the outset that this enormous undertaking, high in terms of financial costs and human resources, is doomed to fail. Worse still, it will actually endanger public health, since substances with no obvious or immediate ill-effects in animals will be approved for human consumption, although they could turn out to be toxic in man. In addition, it is clearly impossible to assess chronic or long-term toxic effects using the animal model (for diseases such as cancer, neurodegenerative conditions, etc.), which are by far of much greater concern to people, since these diseases are often only diagnosed after many years.
Among the most dangerous of these chemical substances are the thousands of pesticide compounds in use in the EU, which pose an especially serious threat to human health. Besides the fact that they are toxic, many are also carcinogenic, neurotoxic, teratogenic, etc. There can no longer be any doubt that pesticides were the major cause of death of those one million people, as described above. The European Commission had already recognised the danger in the 1980’s, and took the step of planning to assess the toxic effects of these pesticides by the year 2003 (see EC directive 1991/414).
At the present time (October 2001), only about 10% of these pesticides have actually been studied. As a result of this failure to meet its objective, the EC has permitted 90% of these toxic products to remain in use, even though it realised the dangers 10 years ago. The EC would therefore appear to be guilty of an act of omission, which has resulted in the premature deaths of millions of Europeans since 1991, a figure which probably exceeds the number of those killed throughout Europe during the Second World War. In order to redress the situation, and to fulfil its obligations to the members of the EU, it is imperative that the EC fully accept its responsibilities in respect to public health. The EC must assess the toxic potential of the 100 000 chemical substances with respect to humans. The assessment must be accurate, reliable and reproducible, qualities which can be met only by truly scientific methods. Since toxicology is the study of the biological activity of a living organism in the presence of a noxious substance, the scientific methods referred to above must be able to demonstrate and detect these interactions, by utilising the most recent advances in modern biology (the scientific board of *Pro Anima may be contacted for further information in this regard). These methods will allow the observation and measurement of toxic effects at the molecular level, as well as at the level of cells, tissues, perfused organs, and even at the systemic level, by means of non-invasive techniques (imaging, scanning, biochemical analysis, etc.). In addition, these methods are able to elucidate the mechanisms of action of noxious substances, revealing possible long-term effects, which is of paramount importance from a consumer protection point-of-view. In addition, to being science-based toxicology, these methods are much faster and less costly, when compared to animal testing.
We therefore consider as totally irresponsible, the EC strategy of testing 100 000 chemical substances by way of empirical, unreliable and irreproducible methods, based largely on the animal model. In this matter, we have called the attention of the EC’s newly appointed director general of the Joint Research Center (JRC) at Ispra. The DG does not challenge our arguments, but instead, simply states that: “the JRC will keep promoting acceptance of alternative methods in the regulatory context.”
Since the EC does not appear to have the infrastructure required for a rigorous approach to toxicological risk assessment, it should remedy the situation without delay. The first step would be to train toxicologists in science-based methods, as described above. Initially, one hundred biology graduates would be chosen from throughout the EU. The training program could be based on that of the scientific committee of the European Workshop in Molecular Toxicology (available from the scientific board of Pro Anima), which has been active in this field since 1989. The one-year program consists of lectures given by international guest scientists, plus laboratory work. The laboratory work could be done in a special Centre, which would be set up and specially equipped for the purpose, and which in turn could serve as a reference centre for all EU countries, and subsequently provide commercial toxicity assessment services to interested outside parties. This project would be complemented by appropriate EC legislation, banning, within a reasonable period of time (e.g. 3-5 years), the use of any chemical substance in the EU which had not undergone the required, science-based toxicity testing.
*Comite Scientifique Pro Anima, 16 rue Vezelay, F-75008
Paris,
Tel. +33 1 45 63 10 89, Fax +33 1 45 63 47 94,
www.proanima.asso.fr
- E-mail <pro.anima@wanadoo.fr>
A Scientific committee (not an animal welfare institution).
Board members are research scientists from government laboratories,
academics and the medical field.
Pro Anima is free of any political, philosophical or confessional tie.
The goal of the committee is to apply progresses in sciences, and in
biology in particular, to the benefit of human health and welfare.
The committee restricts exclusively to scientific and logical
considerations.
Well Mr. Helliker, wouldn't it be reasonable to allow the use of safe and far more effective alternatives until you finalize science-based toxicity testing on your "registered" POISONS?
Respectfully, Stephen L. Tvedten
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