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Environmental Risk Assessment and Monitoring and Surveillance of Transgenic Crops

Environmental risk assessments (ERAs) play a key role in the evaluation of potential impacts of GMOs on the natural environment and on biodiversity.

Before GMOs are approved for deliberate release or marketing in the EU, an environmental risk assessment (ERA) is conducted to investigate whether any potential adverse effects might arise from their use and whether they pose a risk to human health and the environment. The precautionary principle applies. A lack of knowledge and inadequate data make the assessment difficult. The current ERA procedure takes in a range of potential impacts from GMO uses.

Under Directive 2001/18/EC, the marketing of genetically modified organisms is subject to mandatory monitoring and surveillance.


Environmental Risk Assessment and GMO Approval

In assessing potential GMO-related risks to nature and the environment, focus is placed not on where they will be used but on whether and to what extent GMOs can infiltrate the environment and the potential impacts they can have. In the EU, deliberate release of genetically modified organisms is subject to a notification and approval process whose legal basis is provided by Directive 2001/18/EC. The Directive differentiates between the experimental release of GMOs (temporary release in a restricted area) and approving their commercial use (placement on the market). To protect nature and the environment from GMO-related risks, an environmental risk assessment 1) must be conducted which also serves nature conservation needs.

ERAs are conducted by the notifiers themselves and are examined by the competent authorities. Assessments are based on available data. The meaningfulness of ERAs thus critically depends on data quality.


Inherent Risks from Deliberate Release of GMOs

Transgenic plants have been cultivated commercially since 1995. Their production differs from that of conventional plant breeding, which relies on cellular control and regulation to recombine genes (allele) and produce an organism with altered traits. In contrast, a transgenic organism is produced by introducing DNA from a different species while circumventing the cellular regulation system.

This is not done in a targeted way, but by inducing molecular changes specific to the transformation method used. While some of the molecular changes that take place are assessed for their potential impacts, comprehensive assessment and verification does not take place. As living organisms, GMOs can reproduce and disperse their genes throughout the environment. They cannot, therefore, be retrieved and so differ from other substances that are released into the environment such as chemicals, pesticides and pharmaceuticals.


Potential Impacts

Environmental risk assessments involving GMOs look at their traits, any potential adverse effects and the resulting risk to human health and the environment. Some effects only occur after transfer and dispersal of transgenic organisms or their traits. Other effects and issues arise from their use and transformation.

In the cultivation of herbicide-resistant plants focus is placed on the changed cultivation conditions and their effects on the environment and its ecosystems. In the case of insect-resistant maize, assessment centres on whether and to what extent cultivation of the GMO in question can affect non-target organisms and food chains. With regard to second generation GMOs with altered substances, assessment looks at which other metabolic changes are induced and how they effect the compatibility and biodegradability of the GMO and its products.

Annex II of the Deliberate Release Directive lists the types of impacts to be taken into account when conducting environmental risk assessments. These include:


The Precautionary Principle

The Deliberate Release Directive affords special attention to antibiotic resistance markers and its approach to the problem demonstrates the application of the precautionary principle. Antibiotic resistance markers are marker genes used in the production of GMOs and may remain in them afterwards.

Although these genes occur naturally in bacteria and their transfer from transgenic plants to bacteria is thought to be extremely rare, the Directive's Article 4 requires that in the interests of precaution, the use of antibiotic resistance markers in deliberate release and marketing of GMOs should be phased out by the end of 2004 (in the case of experimental release by the end of 2008) if they cause resistance to antibiotics used in human and veterinary medicine and can thus have potential adverse effects on human health and the environment.

The EU applies the precautionary principle in its policies on consumer protection, health, food safety and environment protection. It was a guiding principle in preparing Directive 2001/18/EC and is also required to be applied in its implementation. The precautionary principle is mentioned on many occasions throughout the Directive, including as regards how to proceed in the case of knowledge gaps or unreliable data when conducting environmental risk assessments.


Environmental Risk Assessment Requirements

Compliance with the precautionary principle is a prerequisite of environmental risk assessment. Annex II of the Directive lists further general principles that must be followed when performing ERAs:


1) Because the term 'environmental impact assessment' is already used in the Environmental Impact Assessment Directive, the Deliberate Release Directive (2001/18/EC) uses the term 'environmental risk assessment'.

2) A toxin is a poison given off by bacteria, plants or animals or during bacterial decomposition.

3) See Commission Decision of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. OJ L200/22 dated 30.07.2002.

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Last Change: 13/09/2006

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