Regulation of GMOs - their existing legislative framework, and how this may change in the future

There has been a great deal of debate recently concerning the role of biotechnology and in particular genetic modification and the effects of genetically modified organisms ("GMOs") on the environment. One area of argument centres on how the release and marketing of GMOs is regulated and whether additional controls should be put in place. This article takes a step back from the debate to consider the existing regulatory framework and how this may change in the future.

Legislative framework

Like a great deal of environmental legislation in the UK, the current regulatory controls over the deliberate release and marketing of GMOs originate at EU level. In February 1993, new legislation implementing Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms came into effect - The Genetically Modified Organisms (Deliberate Release) Regulations 1992 ("Regulations"), which are made under Part VI of the Environmental Protection Act 1990 (The Genetically Modified Organisms (Deliberate Release) Regulations Northern Ireland 1994 have corresponding provisions).

Directive 90/220/EEC and the Regulations prescribe environmental protection and human health safeguards relating to:

• the deliberate release of GMOs for research and development and non-marketing purposes; and
• the marketing of products consisting of or containing GMOs.

Separate EU legislation, Directive 90/219/EEC, concerns the controlled use of GMOs, e.g. in laboratories, but this is a separate issue and is not discussed here. Neither are the specific controls governing the marketing of novel foods containing GMOs.

What are GMOs?

The GMOs regulated under this regulatory framework are those produced by certain artificial genetic modification techniques (prescribed in the Regulations) and organisms containing genes or genetic material inherited or derived from such GMOs.

Competent authorities

Before GMOs may be released or placed on the market, consent must be obtained from the appropriate Secretary of State: in England, the Secretary of State for the Environment, Transport and the Regions, acting jointly with the Minister of Agriculture, Fisheries and Food where appropriate; the Secretary of State for Scotland; or the Secretary of State for Wales. Any proposals must also be agreed with the HSE so that issues affecting human health and safety can be taken into account. There are also a number of other statutory consultees which may give opinions (see below).

In practice, however, an applicant need only deal with the DETR which co-ordinates all consent applications and issues all consents. The DETR is also the Secretariat for the Advisory Committee on Releases to the Environment (see below) and acts as the channel of communication with the European Commission for discussions with other member states.

ACRE

The DETR is assisted in its work by the Government's Advisory Committee on Releases to the Environment ("ACRE") appointed by the Secretary of State under Section 124 of the Environmental Protection Act 1990. At present, the Committee consists of scientific experts and representatives from a range of interest groups, including industry, the public and environmental organisations. The purpose of the Committee is to advise the DETR on whether applications for consents to release or market GMOs should be granted and on the conditions that should be attached to those consents.

Risk assessment

The purpose of the regulatory framework is to prevent or minimise any damage to the environment that could be caused by GMOs, including damage to air, water or land and harm to humans, plants, animals, microorganisms and ecosystems (subject to certain exemptions where the object is to control pests or destroy toxic waste). Risk assessment techniques must be used to identify any potential hazards capable of causing harm and this information submitted as part of the consent application.

The DETR recommends a seven stage risk assessment procedure:

• identify the hazards associated with the GMOs;
• identify how each hazard could be realised in the receiving environment;
• estimate the magnitude of harm that may be caused by the realisation of the hazard;
• estimate the frequency or likelihood that harm

will result;

• estimate the risk of harm;
• modify the proposals to minimise the risk of harm; and
• evaluate the overall risk of harm.

Consent procedures

The exact nature of the consent procedure depends on whether the GMOs are to be deliberately released (i.e. for research and development) or placed on the market. In both cases, the ACRE and the competent authorities in other EU member states are consulted. The various stages of the consent procedures are subject to a strict timescale and the competent authorities only have a specific number of days in which to forward applications, make comments etc.

A general condition will be attached to all granted consents that the holder must keep informed of any risks of damage to the environment being caused by the release or marketing. Furthermore, the holder must notify the Secretary of State if there is any new information that would indicate a change in the level of risk and must use the best available techniques not entailing excessive cost (BATNEEC) for preventing environmental damage. Other specific conditions may also be attached to the release or marketing consent.

Deliberate release consent

The application for consent to release GMOs must provide extensive information on the proposals, including a technical dossier to allow the risks of the release etc. to be assessed. A summary of the application must also be included that will be forwarded to the European Commission and other member states.

Shortly after the application is sent to the DETR, the applicant should advertise the application for consent (subject to commercial confidentiality and the protection of national security) by placing a notice giving details of the applicant, the GMOs to be released, the location and general purpose of the release, and the proposed dates of the release in a newspaper(s) circulating in the area(s) likely to be affected by the proposed release.

The applicant must also notify certain potentially interested parties that an application has been made, including the release site owner and regulatory authorities with responsibilities for the environment and nature conservation. Although there is no statutory procedure for making comments following the advertisement or notification, DETR guidance recommends that applicants should include contact numbers for enquiries, draw attention to the existence of the public register where more information can be found (see below) and specify that formal representations may be made to the Secretary of State.

Once the DETR has received the consent application, it must examine it for compliance with the relevant legislation and assess the risks of the release etc.. Under the exchange of information system established by Directive 90/220/EEC, the DETR must send a summary ("SNIF" - Summary Notification Information Format) of the application to the European Commission that is then forwarded to other member states which may request further information and make comments.

Any comments received from member states must be taken into account by the DETR during its consideration of whether to grant consent for the release. At the same time, the comments received from the ACRE and other competent authorities will be considered. The Commission and other member states must be informed of the DETR's decision.
In some cases, a "fast track" procedure may be used for releases of low hazard GMOs, GMO releases that present a low risk because of the management procedures to be used and repeats of certain GMO trials. In such cases, consent application procedures are streamlined and must be dealt with in a shorter time period. Similarly, for releases of genetically modified higher plants, reduced information requirements may apply for consent applications and a simplified procedure for consenting some genetically modified crops has also been adopted.

Marketing consent

The procedure for marketing consent is substantially different. It follows the "mutual recognition" authorisation procedure used for other types of products under EU legislation, whereby only a single application needs to be made for a consent to apply throughout the EU. The application for consent should be made to the competent authority of the member state where the product is to be placed on the market for the first time. The application should include a technical dossier on the GMOs, plus a range of other information on their use, storage, production, handling, import, labelling and packaging. Although there is extensive consultation with other member states, advertisement and notification of interested parties is not a requirement when making an application for marketing consent.

As a first step, the DETR will examine the application for compliance with the relevant legislation. If the application does not meet these requirements it will be rejected. Alternatively, if it does comply, the DETR will send a package of information (including the application, the SNIF and the proposed marketing consent conditions) to the European Commission with a favourable opinion. The Commission will then forward this information to the competent authorities in other member states.

If no objections are received from other member states, the DETR will grant the marketing consent and inform the Commission and the other member states that this has been done. If there are any objections, however, and the DETR and the other competent authorities are unable to reach agreement, the Commission's Advisory Committee will take a decision. If this is favourable, the DETR will grant the marketing consent and inform the Commission and member states of this. If the Advisory Committee does not support the application, then the proposal will go to the Council of Ministers for a decision. If consented, the product may be used throughout the EU.

Enforcement

Once granted, a consent to release or market GMOs may be varied or revoked. Failure to comply with the regulatory requirements is an offence punishable by a variety of fines and custodial sentences. Enforcement action is undertaken by the HSE under an agreement between the DETR and the HSC.


Public registers

In common with many other environmental regulatory regimes, information on GMOs will be placed on the public register maintained by the DETR, including copies of consent applications, risk assessments, ACRE opinions, granted consents, variations, revocations, prohibition notices, convictions etc..

Future changes

It is very likely that changes will be made to this regulatory framework in the near future. At EU level, a proposal to amend Directive 90/220/EEC is at a relatively early stage in the adoption process but is expected to be finalised within the next two years. The main revisions concern more detailed risk assessment requirements, increased public consultation, changes to the consent procedures for GMO releases, possible derogations for releases and products regulated by other EU legislation requiring risk assessment (e.g. novel foods and food ingredients, and medicines), a new requirement for monitoring after marketing consent has been granted and the introduction of seven year time-limited marketing consents. Products already approved would also have to reapply for consent after a seven year period.

Any changes made to the Directive must obviously be implemented into national law in the UK, resulting in the revision of the consent procedures under the Regulations. As a consequence of the recent disquiet over the genetic modification issue, however, the Government is already taking some action at national level although no amendments have been made to the regulatory requirements governing GMOs.

The measures implemented to date include the appointment of ecological and farmland biodiversity experts to the ACRE to facilitate discussion of such issues and agreement between the Government and biotechnology companies on a temporary moratorium on commercial plantings of GM crops whilst more research on the ecological impacts of such releases is gathered. The make up of the ACRE could be altered when a new committee is appointed in June 1999 (the current ACRE was appointed for a three year period from mid 1996). Action may also be taken as part of the Government's general review of policy on biotechnology, including the establishment of a Ministerial Group on Biotechnology and Genetic Modification. In view of the extent of the public and political interest in this area, it is very likely that there will be further developments.

Pamela Castle and Helen Harrison