Volume 2

Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology.

  • Great Britain. Parliament. House of Lords. Science and Technology Committee.
Date:
1993
Catalogue details

Licence: Open Government Licence

Credit: Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology. Source: Wellcome Collection.

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    LL 11 March 1993] [Continued 5. The legislation specific to GMOs is divided into two parts. The Genetically Modified Organisms (Contained Use) Regulations 1992 cover most activities in which GMOs are prevented from escaping into the environment, by physical or by physical combined with chemical or biological means. The Genetically Modified Organisms (Deliberate Release) Regulations 1992 in combination with the Environmental Protection Act 1990 cover the release of GMOs to the environment and the marketing of GMO products. Both sets of regulations are intended to protect the environment as well as human health, and a central feature of both is a procedure for notification and consent. The background to this legislation and its content are dealth with in more detail below. Background to the GMO legislation 6. Regulatory controls on GMO activities are unusual in the health and safety field in that they originated with a caution voiced by scientific practitioners themselves, and have always been a precautionary response to conjectural risks. No historical record of mishap or empirical evidence of special risks associated with genetic modification has been assembled. 7. Fears were first expressed in America in the early 1970s, and in July 1974 a National Academy of Science study group published a seminal letter in the journal “Science” calling for a moratorium on certain GMO experiments. Among the envisaged possibilities causing alarm at that time were that a pathogenic bacterium modified to make it resistant to antibiotics (a property sometimes used as a “‘marker” to enable GMOs to be distinguished from other organisms) might escape and cause untreatable disease, or that organisms might be produced capable of transporting tumour inducing genetic material into the cells of human beings. Voluntary restraint was agreed, while the National Institutes of Health (NIH) set up a Recombinant DNA Advisory Committee and prepared guidelines for GMO laboratory work. Guidelines were published in 1976. Initially they were strict, but since then have gradually been relaxed as knowledge has developed. 8. Meanwhile scientific circles in Britain also moved quickly. The Ashby working party, set up by the Advisory Board for the Research Councils, examined the benefits and hazards of genetic modification work. In its January 1975 report the working party gave genetic modification techniques an ‘“‘amber light’, recommending that with rigorous safeguards they should continue to be used in view of their great potential benefits. 9. To take forward the Ashby work the government convened the Williams working party, which reported in August 1976. It drew up a code of practice for GM laboratory work and recommended the formation of a “Genetic Manipulation Advisory Group (GMAG)” to examine proposals for GMO work. It saw as one of the functions of GMAG the building up of a body of “case-law’’, against which to judge individual experiments. It proposed that regulations should be made under the Health and Safety at Work Act requiring submission of experimental proposals in advance so that GMAG could consider them. GMAG was set up in December 1976, and in 1984 became what is now HSC’s Advisory Committee on Genetic Modification (ACGM). The Health and Safety (Genetic Manipulation) Regulations 1978 required notice to HSE and GMAG of “any activity involving genetic manipulation’’. They were replaced by the Genetic Manipulation Regulations 1989 which extended the notification duty to cover the use of GMOs and the release of GMOs to the environment, though a range of activities judged to be of low risk were subject only to inclusion in a retrospective list. The 1989 regulations remained in force until revoked on 1 February 1993 by the 1992 Contained Use Regulations. Being made under HSWA, both the 1978 and 1989 regulations were confined to the protection of human health. 10. Parallel developments took place in Europe. In 1983 the OECD Committee for Scientific and Technological Policy set up a Group of National Experts for Safety in Biotechnology, to examine the industrial and environmental applications of GMOs which were then beginning to appear as the technology moved out of the laboratory. It published its conclusions in 1986 in an influential document that has become known as the ““Blue-Book”’. It set out and advocated the principles of ‘““Good Industrial Large Scale Practice (GILSP)’”, based on the use of intrinsically low-risk organisms needing minimal containment, as well as providing guidelines for the containment of organisms too hazardous for GILSP safeguards to be sufficient. The Blue Book recorded the Group of National Experts’ conclusion that there was “‘no scientific basis for specific legislation for the implementation of rDNA techniques and applications”. However taking into account the broader concerns of member states the EC Commission began to prepare proposals for directives, drawing on the OECD work. These ultimately became directives 90/219/EEC and 90/220/EEC, adopted in April 1990, the first dealing with the contained use of GMOs and the second with release and marketing. 11. Both directives had the aim of protecting both human health and the environment. This meant that implementation in the UK involved both HSC/E and the Department of the Environment, and two principal parent statutes, the Health and Safety at Work Act and the Environmental Protection Act 1990. The