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
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."
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.
DEVELOPMENT OF UNITED KINGDOM
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.
ACGM's remit is the safety of genetic modification used in containment;
it does not consider ethical or social issues.
This remit extended initially only to the protection of human
health and safety. However, formal guidelines issued by ACGM
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
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)
covers only genetically modified micro-organisms. It has been
implemented in the United Kingdom by the GMO (Contained Use) Regulations
1992. 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".
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.
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
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".
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.
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
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)
The 1992 Regulations and the substantive provisions of the Environmental
Protection Act 1990 came into force in the United Kingdom on 1
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".
"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".
The key test of harmfulness in relation to GMOs is based on their
potential, rather than actual or proven, effects.
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".
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.
41 Report of the Working Party on the Experimental
Manipulation of the Genetic Composition of Micro-organisms, January
1975, Cmnd. 5880. Back
42 Ibid., para. 6.1. Back
43 The general environment was not considered until 1989. Back
44 Health and Safety Executive, p 348. Back
45 Ibid. Back
46 Given statutory force in the Genetic Manipulation Regulations
1989, SI 1989/1810 which superseded and revoked the 1978 Regulations. Back
47 Section 106(1). Back
48 OJ L117 (8 May 1990) pp 1-14. Back
49 SI 1992/3217 as subsequently amended by SI 1993/15, SI 1996/967
and SI 1996/1106. Back
50 Reg 3(1). Back
51 Reg 3(4). Back
52 SI 1996/1106 (which completely replaced SI 1993/15) and SI 1997/1900. Back
53 Reg 9(7). Back
54 Reg 10(4). Back
55 Science and Technology Committee, 7th Report (1992-93), Regulation
of the United Kingdom Biotechnology Industry and Global Competitiveness
(HL 80), para. 4.3. Back
56 SI 1992/3280, as amended by SI 1993/152, SI 1995/304 and SI 1997/1900. Back
57 Environmental Protection Act 1990, section 107(3). Back
58 Ibid., section 107(6). Back
59 Ibid., section 107(7). Back
60 Reg 6(1). Back
61 Reg 11(2)(b). Back