THE ASHBY REPORT

26.  Regulation of biotechnology was first considered in the early 1970s when the scientists at the forefront of the technology called for and achieved a voluntary moratorium until a number of safety questions had been addressed. The United Kingdom was one of the first countries to develop a regulatory strategy. In 1975 a working party chaired by Lord Ashby[41] recommended that genetic manipulation techniques should be allowed to proceed but with rigorous safeguards. They believed that the technology would provide "substantial (though unpredictable) benefits" leading to a rapid advance in our detailed understanding of gene action: "…application of the techniques might enable agricultural scientists to extend the climatic range of crops and to equip plants to secure their nitrogen supply from the air." They concluded that "it is not inconceivable that the technique might ultimately lead to ways to cure some human diseases known to be due to genetic deficiency."[42] At the time it was only possible to modify micro-organisms in the laboratory. The hazards were thus seen to be of two forms, those that might affect the research workers and those that might affect the public at large. The report recommended containment and precautionary measures to protect those working in the laboratories and believed that the barriers thus created would be sufficient to protect the general public. The general environment, including plants and animals, was not considered at that time[43].

DEVELOPMENT OF UNITED KINGDOM REGULATIONS

27.  The Genetic Manipulation Advisory Group (GMAG) was set up in 1976 to examine proposals for genetic manipulation. The Health and Safety (Genetic Manipulation) Regulations 1978 required any activity involving genetic manipulation to be notified to GMAG and the Health and Safety Executive (HSE). In 1984 GMAG was replaced by the Advisory Committee on Genetic Modification (ACGM) which still advises the Health & Safety Executive on the contained use of genetically modified organisms[44]. ACGM's remit is the safety of genetic modification used in containment; it does not consider ethical or social issues[45]. This remit extended initially only to the protection of human health and safety. However, formal guidelines issued by ACGM[46] did include a requirement to provide the HSE with an assessment of the environmental consequences of an intentional release of a genetically modified organism into the environment.

28.  The first piece of primary legislation in the United Kingdom dealing specifically with GMOs and the environment was Part VI of the Environmental Protection Act 1990. It established a structured regime of risk assessment and notification with the aim of preventing or minimising "any damage to the environment which may arise from the escape or release from human control of GMOs"[47]. The Act also provided for a system of consents to import, acquire, release or market GMOs. At the same time as this legislation was passing through Parliament, the European Commission was developing EC proposals on the control of GMOs. These resulted, in April 1990, in the two Directives on contained use and deliberate release (see paragraphs 2, 29-30 and 32-36). The Directives have provided the basis for subsequent United Kingdom legislation regulating the use of GMOs.

SAFETY IN CONTAINMENT

29.  The EC's contained use Directive (90/219/EEC)[48] covers only genetically modified micro-organisms. It has been implemented in the United Kingdom by the GMO (Contained Use) Regulations 1992[49]. The aim of the United Kingdom Regulations is the protection of "persons against risks to their health, whether immediate or delayed, and the protection of the environment"[50]. Although the scope of these Regulations is wider than the EC Directive, extending to activities involving any GMOs (including both animal and plant cell cultures), the provisions relating to the protection of the environment only apply to genetically modified micro-organisms[51]. The Regulations are thus, as regards environmental protection, co-extensive with the EC Directive. For larger genetically modified organisms, such as plants and animals, the regulations only cover risks to human health. The environmental risks associated with work with larger organisms are covered separately by section 108(1)(a) of the Environmental Protection Act 1990, which requires an assessment of environmental risks. There are specific regulations[52] for these larger organisms that require records on the risk assessment to be kept for 10 years, but details of the risk assessment are not notified to Government.

30.  The main requirements of the control regime established by the Contained Use Regulations are: to carry out a prior assessment of the risks to human health and the environment arising from any activity involving genetic modification and to maintain records thereof; to notify the HSE of an intention to use premises for the first time for genetic modification (and for some activities to wait for consent from HSE before work may start); and to notify the HSE of individual activities involving genetic modification, which for some activities may involve waiting for a consent before proceeding. There is a provision enabling the HSE to accept as a single notification "a connected programme of work covering more than one activity involving genetic modification at one site, or a single activity carried on by the same person at more than one site"[53]. Once an intention to use premises for the first time for activities involving genetic modification has been notified to the HSE, there is no further requirement for a separate notification in respect of activities on those premises involving so-called Group 1 micro-organisms: those which are unlikely to cause disease to humans, animals or plants or to cause adverse effects in the environment. Most animals and plants are classed as Group 1 organisms. Thus a controversial experiment need not be notified to the regulators if an uncontroversial experiment has previously been conducted on the same site. The regulations do however provide for a separate notification if there is "a significant change in any premises or activity" after the initial notification, or if any new information comes to light which could affect the particulars previously notified[54].

RELEASE INTO THE ENVIRONMENT

31.  Initially ACGM considered the safety of all uses of transgenic organisms, either by regulation (for contained use) or through a voluntary code of practice (for intentional introductions to the environment). Its formal remit was to consider only human health and safety, as containment assumed neither escape nor release. The committee did, however, evaluate the first deliberate releases and considered their probable impact on the environment.

32.  Part VI of the Environmental Protection Act 1990 provided the first specific regulation to prevent or minimise the damage to the environment from GMOs. The Act required a risk assessment to be made and submitted to the Department of the Environment. In certain cases a consent had to be obtained and the Advisory Committee on Releases into the Environment (ACRE) was established to advise the Secretary of State responsible for the environment on such matters. Thus the United Kingdom, unlike most other countries, had by 1990 evolved its own broad regulatory structure[55] and system of scientific advisory committees. This system has been copied by many countries, including those as far afield as Brazil, Russia and South Africa.

33.  At the same time, the Commission was preparing Community legislation. The deliberate release Directive has been implemented in the United Kingdom by the GMO (Deliberate Release) Regulations 1992[56]. The 1992 Regulations and the substantive provisions of the Environmental Protection Act 1990 came into force in the United Kingdom on 1 February 1993.

34.  The deliberate release Directive and the United Kingdom Regulations both apply to the release into the environment of all GMOs (as defined), whether micro-organisms or not. Their principal objective is to prevent or minimise any damage to the environment, defined as "the presence in the environment of GMOs which have (or of a single such organism which had) escaped or been released from a person's control and are (or is) capable of causing harm to the living organisms supported by the environment"[57]. "Harm" means "harm to the health of humans or other living organisms or other interference with the ecological systems of which they form part and, in the case of man, includes offence caused to any of his senses or harm to his property"[58]. The key test of harmfulness in relation to GMOs is based on their potential, rather than actual or proven, effects[59]. Controls on the deliberate release and marketing of GMOs are based on a general prohibition, followed by procedures for obtaining prior consent to releases. The Regulations prescribe the information to be contained in an application for consent to release GMOs, which has to be accompanied by a "statement evaluating the impacts and risks posed to human health and the environment"[60]. In the case of applications for consent to market a genetically modified product, "an assessment of any risks for human health or the environment related to the GMOs contained in the product, including information obtained from the R&D stage on the impact of the release on the environment", is required[61].