UK and European Regulation of Environmental Safety of Genetically Modified Organisms - Deliberate Release.



Since October 2002, the revised version of the EU Deliberate Release Directive (2001/18/EC) has been implemented in UK law. In the UK, the Secretary of State for the Environment (who actually licenses all experimental and commercial uses of GMOs) is advised by the Advisory Committee on Releases to the Environment (ACRE).

In April 2004, a new set of EU Regulations will become law. These will cover all GMOs that are to be used for human food or animal feed. GMOs that come into this category will only have to submit one application under these regulations to cover human food, animal feed and environmental safety. The environmental assessment part of these applications must comply with the requirements of the Deliberate Release Directive described below.

If a GMO is not at the stage of commercialisation and/or is not to be used for human food or animal feed use, it will still have to be evaluated under the Deliberate Release Directive. The following outlines the way GM crops have been assessed and the improvements and short comings in the new regulations.

The Deliberate Release Directive covers:

  • experimental releases of GMOs to allow their performance, behaviour and interaction with outside factors to be studied;
  • marketing authorisations of GMOs to be used on a commercial scale, or which are to be imported from non-EU countries for uses such as processing in the food and animal feed industries.

How the Regulations Work

  • All environmental releases of GMOs must be licensed under the Deliberate Release Directive. The case-by-case approach is intended to be precautionary.
  • Experimental releases are covered by Part B of the Directive (following the general provisions of Part A);
  • Safety is assessed by a 'step-by-step' progression using data from earlier experiments to inform decisions about the safety of future field trials.
  • At each stage, it is assumed that the presence or absence of effects will be identified, thus allowing for a decision to be made on whether a lower containment level can be allowed.
  • 'Fast track' procedures can be introduced for some crop species where the characteristics of both the inserted gene and the host organism are well known. In the UK, these applications are considered by the ACRE secretariat and not the full committee and decisions are made within 30 days rather than the normal 90 day period.
  • 'Simplified procedure' approvals can be given either for a single release or for a programme of releases taking place over several years and at several sites.
  • The risk assessment includes the conditions of release and the receiving environment, and interactions between the GMOs and the environment such as characteristics affecting survival, multiplication and dissemination, and interactions with the environment.
  • There is also a requirement for public consultation about the proposed release but the terms of the consultation are restricted to those areas included within the Deliberate Release Directive and do not include socio-economic impacts.
  • Marketing authorisations are covered by Part C of the Directive and Europe-wide approval for marketing may be given following a risk assessment which considers:
  • Information about the GMO - the recipient and donor organism, the vector and the GMO.
  • Conditions of release and the receiving environment.
  • Assessment of potential health effects.
  • Interactions between the GMOs and the environment - characteristics affecting survival, multiplication and dissemination, interactions with the environment, potential environmental impact.
  • Information provided derives from earlier field trials either in Europe or elsewhere.
  • The potential for direct and indirect impacts including the way in which the GMO will be used if this differs from equivalent non-GM organism.

If new information becomes available that a product may be a risk to human health or the environment, a Member State may temporarily restrict its use or sale, pending a decision at EU level. A monitoring plan has to be provided and approved. The European Commission should conduct a public consultation about marketing authorisations.

The marketing consent is given for a time limited period of 10 years, following which there must be a reassessment.

Shortcomings of the Past Regulatory Approach

These included:

  • A case-by-case approach precluded an assessment of cumulative impacts. For example, one crop containing a toxin which kills insects may seem relatively innocuous. However, if many such crops are authorised, the toxin could affect the whole food web either by killing beneficial insect life or by removing an important food source for higher species. This is not specifically included in the risk assessment.
  • Effects on other farming systems were not considered - for example, the problems of cross-pollination of organic and conventional crops. GM oilseed rape pollen can travel 1.5 to 2 kilometres.
  • Small-scale trials cannot mimic the complexity of the natural environment. Unexpected outcomes are probable and past ACRE chairperson, Professor John Beringer, has even acknowledged that, "We can't really learn anything from [small-scale field trials]" - ENDs report 283 August 1998 p.22.
  • Most experimental trials only provide information on economic characteristics such as yield, little of which is relevant to risk assessment. There is minimal research into ecological effects and, when undertaken, this is only conducted for one to two years. Ecologists have recommended that at least three years data are needed. Therefore, there is little relevant information with which to make assessments of safety.

Positive Improvements in the Revised Deliberate Release Directive

  • The Precautionary Principle is explicit in the approach to risk assessment. This means that lack of scientific proof of harm cannot be used to obstruct measures intended to prevent harm arising.
  • The increased scope of the Directive to include 'risks to human health and the environment whether direct or indirect, immediate or delayed'. This means that the potential for effects on the whole food web (such as secondary effects on birds if food supplies are lost because beneficial insects are affected) has to be included in the assessment, including those that may not arise for many years.
  • Traceability at all stages. Without this, it will not be possible to monitor for effects of releases of GMOs or for labelling of food and feed. A regulation to implement traceability has now been agreed. (See section 4)
  • Labelling at all stages of the use of the GMO. Without this, consumer choice cannot be provided and monitoring for adverse effects will be impossible. Again a new EU regulation to implement this has now been agreed under the GM Food and Feed Regulations. (See section 4)
  • Public consultation on experimental (Part B) releases. This would mean that people living near trial sites would have a say in whether they should take place. However, public consultation provisions for marketing consents are very poor and are via the European Commission.
  • Period of consent not exceeding 10 years. After 10 years, companies would have to reapply if they wanted to continue selling their GMO. This would allow for a review of all the evidence and allow for GMO products to be taken off the market. Without this, GMO products could continue to be sold while arguments took place over whether there really was evidence of harm (as with pesticides, for example).
  • The potential for geographical restrictions on areas where GMOs are grown or sold. This is important because ecosystems and agricultural systems are not the same in different parts of Europe and what is considered acceptable in, say, Italy may not be so in the UK.
  • Monitoring, including surveillance for unexpected effects after GMOs are given marketing consent. This is crucial if we are to increase our knowledge of how GMOs behave in the environment.
  • Consideration of the impacts of the farming practices associated with the use of a GMO. This is important to allow consideration of how a GM crop may affect agricultural practice and therefore the environment. For example, the use of herbicide tolerant crops such as Monsanto's Roundup Ready soybean, will alter the pattern of herbicide use. If more broad spectrum herbicide is used, more weeds will be killed and other wildlife put at risk from loss of food supply.

Areas Where Improvements are Needed

  • Civil liability or insurance for environmental harm. This has not been included and whilst some of the EU Member States argued for a separate EU Liability regulation, the EU Commission has recommended that this be dealt with under national laws.
  • Public consultation on marketing consents. The Commission is required to consult on marketing (Part C) releases but there is no requirement for Member States to do so. Not only does the Commission have little public confidence but it is remote from, and not accountable to, European citizens. Therefore, public consultation on marketing consents must be made the responsibility of Member States and sufficient time allowed for public consultation - at least 90 days.
  • A ban on the use of antibiotic-resistant marker genes. The Directive only includes a requirement to phase out antibiotic resistance genes in use when they are judged to bring adverse effects. This leaves the door wide open for the continued use of antibiotic resistance genes even though these play no role in the final product and can be removed (although this takes some time and money that the industry is reluctant to expend). The Directive should also allow other genetic manipulations to be banned if similar, unnecessary and potentially harmful genes are used in future.
  • Socio-economic impacts, such as the impacts on organic farmers must be considered in the assessment. If there is cross-pollination from GM to organic crops, organic farmers could lose their status and their livelihoods - this is not considered in the new Directive.
  • No exclusions of GMOs from regulation should be allowed. If GMOs have characteristics which provide so-called biological containment by, for example, preventing pollen formation or using 'Terminator' technology, they could be excluded from assessment under the new Directive (Articles 2 & 3).
  • All GMOs must continue to be assessed under the Deliberate Release Directive. The current Directive allows for GMOs to be assessed under other regulations depending on the type of end product involved (under pesticide or plant variety regulations for example). Even if equivalent assessments have to be included under other regulations, there may not be appropriate expertise available, environmental protection could be weakened and, because of the added complexity, it would be difficult to monitor new GMO introductions.
  • The Commission must never be the final decision-maker. Under this new Directive, the Commission can overrule the Council in cases where the Council does not make a decision (adopt or oppose by qualified majority) within three months. The desire for speed should not be allowed to compromise democratic decision making.

Further Information:

For information about EU wide releases for field trials and commercialisation:

For further information about the environmental safety regulations and UK issues contact:

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