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MONTH: January/February 2007

New European Parliament chemical policy will increase animal testing


BRUSSELS--The Environment Council of the European Parliament on December 19, 2006 unanimously ratified REACH, a consolidated chemical safety regulation approved by the Plenary of the European Parliament on December 13.

The REACH acronym is short for "registration, evaluation, authorisation and restriction of chemicals." Three years in negotiation between the Environment Council and the main body of the European Parliament, REACH replaces more than 40 older regulations. Applying to "all substances manufactured or imported in quantities over 1 metric ton per year," according to a summary description released to news media, REACH "is expected to be applied to approximately 30,000" chemical products.
But it will result in increased animal testing, at least in the near future.

"Current estimates of the number of animals to be affected range from the 16 million predicted by the chemical industry to 45 million over 15 years, calculated by Germany's Federal Institute for Risk Assessment," wrote London Times correspondent Nicola Smith.

"The aim of REACH is to ensure that health and the environment, including animals, are protected from adverse effects due to dangerous chemical substances," the media briefing stated, acknowledging that "Acquiring the necessary knowledge on the properties of substances will entail some animal testing. However," the briefing paper asserted, "REACH has been designed to reduce animal testing to the absolute minimum," incorporating an "obligation to share all data generated through testing on vertebrate animals, and by the provision that for large volume substances, testing proposals must be approved by the [REACH] agency before new tests on animals will be performed.

"An increase of 3% of animal testing is expected for the first eleven years after adoption of REACH," the briefing admitted. "After 11 years, the burden of lack of knowledge about substances in use today should be adequately addressed, and the numbers should then go down steeply because only a few new substances per year will have to be tested."

European Union Science and Research Commissioner Janez Potocnik on December 18 told the European Partnership for Alternative Approaches to Animal Testing conference in Brussels that REACH may require more animal testing than was initially estimated, but said "This just makes me even more determined to speed up our work in this area [developing non-animal tests], so that we can reduce these numbers by as much as half."

Potocnik noted that the EU agreed in 2003 to ban testing cosmetics on animals after 2009, and that the European Commission in June 2006 began a review of laboratory animal welfare, with findings due in early 2007.

Potocnik pledged continuing support for the European Centre for the Validation of Alternative Methods. "I can assure you," Potocnik concluded, "of my firm commitment, and that of the European Commission, to research that will develop reliable alternatives so we can refine, replace, and reduce animal testing in the future."

Conflicting reports

Midway between the European Parliament approval of REACH and the Environment Council ratification, the British Medical Journal published a review of recent studies in six areas of medicine by a team from the London School of Hygiene & Tropical Medicine, who found that animal testing matched human results in only three of the six.

Lead author Ian Roberts told BBC News that his investigations found some animal studies were poorly carried out, involving too few animals, and that they could be influenced by "design or publication bias." Roberts suggested that animal experiments could be designed to better reflect human experience, and that there may be some areas of drug research where animal testing is relevant, but others where it is not.

But one day before the European Parliament approved REACH, a review of the scientific validity of non-human primate research commissioned by the Royal Society, the Medical Research Council, the Wellcome Trust, and the Academy of Medical Sciences concluded in the words of lead author Sir David Weatherall, a retired Oxford University geneticist, that "There is a scientific case for careful, meticulously regulated non-human primate research, at least in the foreseeable future, provided it is the only way of solving important scientific or medical questions and high standards of welfare are maintained."

The Weatherall report recommended that Britain should consolidate the 13 university primate labs and six primate labs operated by private enterprise into four new facilities.

"As we had feared," said British Union for the Abolition of Vivisection chief executive Michelle Thew, "this report turned out to be yet another whitewash of the important scientific and ethical issues involved in experimenting on non-human primates."

"Despite a ringing endorsement for the work being done to reduce primate use, the Weatherall report did not go far enough in trying to map out the priorities for development and adoption of new alternatives," commented National Centre for the Replacement, Refinement and Reduction of Animals in Research chief executive Vicky Robinson.

"Regardless of the scientific validity of primate experiments," added Royal SPCA Research Animals Department chief Maggy Jennings, "that these animals are confined and used in research is incredibly sad."

"Last year 4,652 medical procedures were carried out on monkeys," wrote Guardian science correspondent Ian Sample, "representing 0.16% of all animal tests. The research involved 3,115 monkeys, 12% up from 2004. Three-quarters of the monkeys were used for toxicology tests on new drugs. The remainder were used in studies of basic neuroscience and debilitating conditions. Experiments on great apes, such as chimpanzees and gorillas, are expressly forbidden in Britain," Sample noted, "but experiments with smaller primates are permitted."

The percentage of British studies done on non-human primates declined in 2005, even though more primate research was done, because the total number of animal experiments rose to 2.9 million, the most in 13 years, the Home Office reported in July 2006.

"Genetically modified animals accounted for nearly one million procedures, but two-thirds are those involved in breeding genetically modified offspring who are used in experiments," wrote Guardian science correspondent James Randerson. "Without these breeding animals, there would have been a slight decrease in the overall figure. The number of unmodified animals used was down 1%, to 1.65 million."