Dispute over public registers on engineered organisms

Last-minute changes to new regulations which may block public access to environmental information on genetically manipulated organisms (GMOs) were highlighted during a parliamentary debate on 11 February. The changes were introduced in response to lobbying by the biotechnology industry, but at least one of the new rules appears inconsistent with EC requirements and may land the Government in hot water with the European Commission.

The new regulations are in two sets, and came into force on 1 February (ENDS Report 216, p 36 ). One implements an EC Directive on the contained use of genetically modified micro-organisms. The second implements another Directive on the deliberate release of GMOs to the environment, whether for research purposes or as products.

The regulations went through two consultation exercises, initiated in October 1991 and August 1992, but attracted little public scrutiny. The debate in a House of Commons Standing Committee on Statutory Instruments on 11 February was the first occasion on which the environmental aspects of GMOs had been discussed in Parliament since the passage of the Environmental Protection Act 1990.

The principal speakers in the debate were Labour's environment spokesman Chris Smith and Environment Minister David Maclean. Mr Smith focussed on the regulations dealing with public registers of information on GMOs.

The EC Directives contain virtually identical provisions on public access to information. Both oblige the authorities not to divulge any "confidential" information submitted to them and to "protect intellectual property rights relating to the data received." Where a notifier believes that the disclosure of any information submitted to the authorities "might harm his competitive position", he can apply for it to be treated as confidential. It is then for the authorities to decide whether to accede to his request.

However, the Directives go on to stipulate that "in no case" may certain information be kept confidential. This includes the identity of the notifier and the GMO concerned, the purpose and location of its contained use or deliberate release, methods and plans for monitoring and emergency response, and "the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects."

As Mr Smith pointed out, the UK's implementing regulations are not consistent with each other on this issue, and in at least one case appear to involve a breach of the EC requirements.

The case concerned is a provision in the rules on contained use of GMOs which empowers the Health and Safety Executive to withold information "to the extent and for so long as it is necessary to protect" a notifier's intellectual property rights, even if the information is of a kind which, under the EC Directive, should "in no case" be witheld.

There was no hint in the consultation papers that the Government intended to introduce a barrier to disclosure of this kind, and Mr Smith suggested that it "has taken too much notice of lobbying by the industry and of anxieties about commercial confidentiality and potential patent rights."

Mr Smith also pointed out that the deliberate release regulations are not entirely at one with the EC rules. These provide that among the information which must "in no case" be witheld are a "description" of the GMO and the "purpose" of the release. However, the regulations require the disclosure of only a "general description" of the GMO and the "general purpose" for which it is to be released, unless the GMO is to be placed on the market or a "detailed description" of the GMO and the purpose of the release have already been published. This may result in the witholding of information on experimental releases. Again, these barriers to disclosure were not foreshadowed in either consultative document.

The regulations on public registers were flawed, Mr Smith concluded, because they had been "truncated by misguided applications of confidentiality" and because they were not consistent.

In response, Mr Maclean asserted that the regulations "will achieve complete public confidence." If the Government had gone "completely overboard for complete freedom of information", "companies would close down their genetic manipulation research, as has happened elsewhere in the world, and pursue other, more conducive research."

The Minister went on to urge Mr Smith to consider the purpose of the registers before he demanded the disclosure of additional information. Registers "cannot be informative if they are not easily comprehensible to everyone with an interest and not just to the specialist." If anyone was dissatisfied with the information in the registers, they could ask the applicant or use the new Environmental Information Regulations to seek the information from public bodies, and "provided that the information requested is not confidential for commercial or other reasons, it will be given."

The Minister denied that the contained use regulations did not comply with the EC rules. Since contained use operations "usually" relate to the earliest stages of research when the commercial potential of the work is unclear, "more broadly based protection for intellectual property rights is justified at this stage. However, once a patent has been granted, the relevant information will, in any case, enter the public domain." That account of the inconsistency between the Directive and the regulations leaves much to be desired.

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