Lords get hot under the collar over biotechnology regulation

A precautionary approach to the regulation of genetically modified organisms was strongly supported by the European Commission and Greenpeace at one of the last - and most acrimonious - hearings in a House of Lords' inquiry into biotechnology. Both bodies also disputed industry claims that the current EC rules impose an excessive burden and that they are not based on sound science.

The inquiry by the House of Lords Select Committee on Science and Technology has been under way since March. Evidence has been heard mainly from biotechnology businesses and research institutions primarily on the implications for the competitiveness of the UK's biotechnology industry of two EC Directives on contained use and deliberate release of genetically modified organisms (GMOs).

The industry has insisted that these pose an excessive burden and act as a disincentive to would-be investors. It maintains that more funds are flowing into the USA's biotechnology industry because it enjoys the benefits of a "vertical" regulatory system that assesses the risk of each invention according to its intended end-use and does not discriminate against products of biotechnology by imposing an additional, "horizontal", regulatory burden (ENDS Report 220, pp 27-28 ).

Moreover, UK companies point with envy to the fact that field trials of genetically modified varieties of six commercial crops were granted "non-regulated status" earlier this year after the US Department of Agriculture concluded that the environmental risks are lower than initially thought.

The inquiry has also been told by industry that the EC Directives were drawn up without proper consultation and went against the most relevant scientific advice available at the time, namely that of the OECD's Group of National Experts on Safety and Regulations in Biotechnology. In addition, industry has claimed that the Directives were subsequently "hijacked" by green elements when they were debated by the European Parliament, producing "dreadful" results.

Industrial witnesses at the inquiry have played heavily on a report produced by the OECD group in 1986. One of its conclusions, but not a specific recommendation, was that "there is no scientific basis to justify specific legislation for recombinant DNA organisms."

However, speaking for the European Commission's Directorate for Internal Market and Industrial Affairs, Kirtikumar Mehta told the inquiry in June that the Commission had closely followed the OECD recommendations on risk assessment procedures and data requirements in drawing up the Directives.He denied there had been inadequate consultation, saying that Brussels drew on the expertise of its own scientists and that of officials from the Member States during the two years the Directives were being negotiated.

Mr Mehta went on to argue that the legislation had been designed to accommodate a wide range of views. "When the discussion started, there was quite a lot of pressure that we should not permit this kind of technology at all," he said. "But we have taken a precautionary approach that until we are sure about the risks, they should be minimised."

He denied that the Commission had been excessively cautious and bureaucratic in its approach, pointing out that the Directive on deliberate release of GMOs contained provisions to allow for regulation to pass to a vertical approach as experience was gained.

Within the past few months, the Commission has been approached by Belgium, France and the UK, which feel they now have sufficient experience with approving releases of GMOs to be able to suggest ways of simplifying the authorisation procedures laid down by the deliberate release Directive. The Commission is responding by drawing up criteria which applications for simplified procedures will have to follow.

Mr Mehta contested industry claims that the USA was employing a more reasonable approach, saying that the US Government had gone through the same process of waiting until it had sufficient experience of implementing its regulations before relaxing them. And he felt it was an "open question" whether the EC rules were responsible for loss of investment to the USA. Other important factors, such as differences in R&D capacity and the larger and more varied market in the USA for sectors such as pharmaceuticals, were also involved.

The precautionary approach to legislation on GMOs was strongly supported by Greenpeace when its Scientific Director, Dr Susan Meyer, appeared before the Committee in June. Her evidence was received with undisguised hostility by the Committee, and at one stage the hearing had to be stopped because the chairman felt it had "become more of an argument than an examination of a witness", and a Committee member was asked to contain himself.

Greenpeace is opposed to all releases of GMOs to the environment. Insufficient knowledge about ecosystems is available, said Dr Meyer, for confident predictions to be made that the risks involved are insignificant.

According to Greenpeace, biotechnology, "unlike any other, allows the transfer of genetic material between unrelated species. Claims that it is simply a speeding up of other breeding techniques miss the point. There is no other means by which genetic material could be transferred from a human to a plant or a fish. The concerns over environmental safety relate directly to the way the technology transcends species barriers. The reconstruction of nature is not a trifling technicality to be lightly countenanced."

Moreover, Greenpeace, like the Green Alliance in an earlier hearing, warned that industry claims about the benefits of biotechnological inventions should be treated with suspicion. For example, one claim often made by agrochemical companies is that the products of biotechnology are necessary to meet the food needs of a growing global population. The group argues that "often such claims ignore the fundamental political, economic and social factors underlying the problems. There is a temptation to try and escape these problems by escalating technical `fixes'". A single-minded pursuit of biotechnology could mean that other, less risky, alternatives would be overlooked.

However, given that the current regulatory regime permits releases to the environment, Dr Meyer argued strongly against any relaxation of the EC Directive on deliberate release of GMOs and the imminent transfer of certain product groups out of its scope, since the legislation had been designed to protect the environmental, not the commercial, needs of society.

"Regulation on a process basis is critical if environmental protection is to be taken seriously," she argued. "It seems sensible to keep the risk assessment under one expert committee who have seen and know all the trials and have analysed the data and keep that expertise in one area, rather than split it up as is the case when you go to product-based regulation."

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