{"id":240,"date":"2010-07-09T22:40:01","date_gmt":"2013-01-11T21:42:05","guid":{"rendered":"http:\/\/antidote-europe.org\/?p=240"},"modified":"2015-07-04T10:11:37","modified_gmt":"2015-07-04T09:11:37","slug":"reach-a-chemical-dinosaur","status":"publish","type":"post","link":"https:\/\/antidote-europe.eu\/en\/reach-a-chemical-dinosaur\/","title":{"rendered":"REACH: a chemical dinosaur?"},"content":{"rendered":"
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REACH, the European Community Regulation on chemicals, is an apology to society for the thousands of poorly-tested industrial chemicals that now pervade the environment and our bodies. But\u00a0REACH\u00a0regulations still allow traditional unquestioned animal experiments.<\/strong><\/p>\n<\/div>\n<\/div>\n

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This article serves two purposes. It is a compte-rendu of the conference presented in Vannes on 21 June 2008 by Andr\u00c3\u00a9 M\u00c3\u00a9nache and it is a bugle call to all responsible scientists, regulators and members of the public to help avoid a catastrophe.<\/p>\n

REACH\u00a0is the European Community Regulation on chemicals. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances and entered into force on 1 June 2007. The task of managing this huge program has been assigned to the newly formed European Chemicals Agency (ECHA), located in Helsinki Finland. To re-iterate, the stated aim of\u00a0REACH\u00a0is to \u201cimprove the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances\u201d.<\/p>\n

It is our view that the\u00a0REACH\u00a0program represents an apology and an admission of guilt to society for the thousands of poorly tested industrial chemicals that now pervade our bodies and the environment. It would not be helpful at this stage to engage in a philosophical debate on whether to apportion blame more to industry than to society \u2013 or vice versa \u2013 for our current predicament, surrounded as we are, by thousands of chemicals \u2013 some good, some bad, some very bad. To try to answer the question, \u201cwho created the need for so many chemicals in the first place \u2013 society or industry?\u201d is like trying to solve the riddle of which came first \u2013 the chicken or the egg?<\/p>\n

Rats and mice are still being fed to this chemical dinosaur<\/h2>\n

The concept and framework of\u00a0REACH\u00a0are fait accompli. We now have the onerous task of trying to tame a chemical dinosaur\u2014to try to assess the toxic risk of some 30,000 chemicals. Although the\u00a0REACH\u00a0regulations allow room for innovation (e.g. Annex XI*), the current test regimen involving traditional animal experiments remains essentially unquestioned with respect to their relevance to human health. In addition, any attempt to introduce a new test method will require the submission of \u201cproof of principle\u201d, followed by a fairly lengthy \u201cvalidation\u201d procedure, which is usually enough to put most people off, including industry.<\/p>\n

Trying to challenge a European Commission (EC) directive to show that the current testing regimen is out of date as well as irrelevant, is by no means an easy feat. In fact, the EC is essentially immune to legal challenge, except in rare instances (e.g. Sweden versus Commission of the European Communities**). However, within the framework of the\u00a0REACH\u00a0regulations, there are several ways in which to promote good science and thus eliminate \u201cbad science\u201d (a reference to animal testing, made by the outgoing director of\u00a0ECVAM). The view of Antidote is that using animals to set \u201csafety limits\u201d for human chemical exposure is meaningless in terms of public health. With more than 250 strains of rats and 330 strains of mice to choose from, it is possible to prove that virtually any chemical is \u201csafe\u201d or the opposite. When talking about safety, the operative phrase should be: \u201csafe for whom (which species)?\u201d<\/p>\n

The EU scientists and regulators who are allied with animal testing are willing to consider using non-animal methods, but on condition that these methods first undergo \u201cvalidation\u201d. Validation of a method implies that it has been scientifically evaluated for a particular purpose (relevance) and, in addition, that it is reliable and reproducible. Although the concept of validation is a sound one, it raises two pivotal questions:
\n(i) to what extent have animal experiments been validated ? In asking this question, we make the bold assumption that animal tests have all been validated. However, this is in fact a \u201cred herring\u201d, because it detracts from the real issue \u2013 the need to validate test data with respect to humans \u2013 by testing human biological material, including cells and tissues of human origin, in addition to non-invasive clinical studies of human volunteers and patients. There are no reliable models for the study of humans other than humans themselves.
\n(ii) why is validation and regulatory acceptance so painfully slow ?<\/p>\n

The regulatory system is out of step with scientific facts<\/h2>\n

These two aspects of validation warrant closer inspection. Incredibly, animal experiments have never undergone formal validation (1), a fact which prompted a former head of\u00a0ECVAM*** to put forward the concept of \u201cinvalidation\u201d, saying that it was clear that many currently accepted animal tests do not, and could never, meet the agreed criteria for validation (2). This initiative \u2013 not surprisingly \u2013 appears to have been largely ignored both by industry and by regulators. For the authorities to admit that animal experiments don\u2019t work would simply be too big a public embarrassment.<\/p>\n

The second problematic aspect of validation is the time taken to develop and validate a non-animal method and then await regulatory approval. A current example to illustrate this point is the replacement of the rabbit pyrogenicity (fever) test by a non-animal method. A non-animal method was developed in 1988 by UK scientists, but was not validated until 2006 (3). Informed sources predict that this method will obtain regulatory approval in 2010, as an official replacement for the rabbit test \u2013 a total of 22 years to achieve one single animal test replacement! Many people ask the burning question: \u201cwhy does this process take so long?\u201d The answer is quite sad. It is due partly to government and industry incompetence and partly because animal experiments have been around for years and both regulators and industry are familiar with the animal data, even if it is irrelevant to human health. Industry knows that in order to develop and introduce a new, non-animal method it will need to spend some money, although that in itself is not a barrier. A much bigger worry, however, is the risk that the method will not be accepted by the regulatory authorities. This is especially likely to happen when a test method developed using human cells and tissues is compared to historical animal data.<\/p>\n

A test case: acute toxicity<\/h2>\n

One of the most basic requirements of any chemical testing program is to determine the amount of a substance that can kill an individual in a single dose (acute toxicity).REACH\u00a0is no exception to this rule, but will these (animal) tests simply be an exercise in blind information gathering \u2013 a stubborn refusal to let go of the \u201cbad science\u201d \u2013 ignoring the fact that no animal species is a reliable biological model of humans?<\/p>\n

Initially,\u00a0REACH\u00a0called for acute systemic (whole body) toxicity data via a single route, and only for chemicals marketed in volumes of more than10 metric tonnes per annum (4). However, amendments tabled by several EU member states have led to acute lethality data being required for all substances covered under\u00a0REACH\u00a0(i.e., 30,000 chemicals marketed in volumes greater than 1 tonne per year), plus a further requirement for lethality data via a second exposure route for approximately 10,000 chemicals marketed annually in volumes greater than 10 tonnes (5).<\/p>\n

Since virtually every chemical in commerce has been tested using an oral LD50 (lethal dose that kills 50% of the test animals) or reduction\/refinement variant thereof, the second route study will either be inhalation or dermal \u2013 which consume 30-40 animals per test, according to\u00a0OECD\u00a0Test Guidelines 402\/403 (6), and for which \u201calternative tests\u201d have yet to be accepted. In addition, there are many more \u201calternative tests\u201d yet to be invented, since current regulations still rely largely on animal experiments as their point of reference, rather than test methods that are directly applicable to humans, as pointed out by Antidote in 2005. We are told that these human based methods must first undergo validation \u2013 a mission impossible \u2013 since\u00a0ECVAM\u00a0does not possess animal data against which to compare human cell data! So for the sake of expedience, 10,000 chemicals are going to be tested once more on animals, even though the resulting data will be meaningless in terms of protecting human health and the environment. Although this allows manufacturers to satisfy regulatory requirements, it will not serve the interests of the consumer public.<\/p>\n

An admission by the pharmaceutical industry<\/h2>\n

This situation sounds like a catastrophe in the making. Interestingly, however, a scientific publication that appeared at the beginning of the year may offer a way to challenge animal testing in\u00a0REACH. A consortium of 18 pharmaceutical companies announced that they were looking to reach an agreement with regulatory authorities to scrap acute toxicity testing, since this category of test was considered redundant. This move has actually opened up a Pandora\u2019s box of shocking news \u2013 the admission by industry that these \u201ctraditional\u201d toxicity tests actually served no purpose. Although the present discussion refers only to acute toxicity tests, it may herald the beginning of a \u201cdomino effect\u201d with respect to all the other regulatory animal test requirements. In addition to acute toxicity, we should also revise testing requirements for cancer, neurological disease, reproductive malformations, foetal damage, and more, for which the animal data is simply unreliable, and for which the traditional studies of epidemiology (study of human populations) may be unsuitable because it may be many years before disease symptoms appear.<\/p>\n

This strange turn of events begs the question: how long have industry and the regulatory authorities known about this situation and kept quiet about it? The answer is: about 30 years!! (7).<\/p>\n

One has no doubt that it is public pressure and the efforts of the animal welfare lobby that have contributed significantly to this timely expose and raises the suspicion that there are more redundant toxicity tests that the public is not being told about (we would say that all animal toxicity testing is irrelevant and therefore redundant). An opportunity thus presents itself to challenge the\u00a0REACH\u00a0chemicals program, in the light of this revelation by the pharmaceutical industry.<\/p>\n

Antidote Europe would like to inform its readers and supporters that this line of investigation will now be vigorously pursued by all possible legal avenues in order to ensure that\u00a0REACH\u00a0achieves its stated aim \u2013 the protection of human health and the environment \u2013 through the use of modern toxicological methods and good science.<\/p>\n

*Annex XI (General rules for adaptation of the standard testing regime)
\nArticle 1.2. Weight of evidence
\n\u201cThere may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.
\nWhere sufficient weight of evidence for the presence or absence of a particular dangerous property is available: \u2013 further testing on vertebrate animals for that property shall be omitted\u201d.<\/p>\n

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