The regulatory process is intended to be precautionary. GeneWatch believes it is important that the review process takes due account of the this and the implications for how uncertainty and ignorance is documented and evaluated.

Key issues this area should address include:

• How robust is the theoretical underpinning of the environmental risk assessment system, which takes a case-by-case, step-by-step approach? What are the limitations of such an approach?
• Where do the human, institutional and scientific uncertainties lie in relation to the assessment of environmental safety? Have sensitivity analyses been conducted? Are all these areas addressed in the regulatory process?
• What statistical methodologies are used in the regulatory assessment process and how robust are these? Could these be improved and do they take a precautionary approach?
• How are judgements made about which hazards to include and exclude? What are the key assumptions that have been made and what data support these? What are the consequences if such assumptions prove to be wrong?
• What is the quality of the data that have been presented in environmental risk assessments for Part B and Part C consents? How many years of assessment should be required to draw conclusions about impacts? To what extent can studies on environmental impact on one country be extrapolated to others? What scientific standards should be set to ensure data quality?
• What are the consequences of the current intellectual property rights, covering genes, cells, basic GM techniques, plants and animals for scientific research and innovation both in the UK and the rest of the world.

Papers and reports that should form part of the evaluation include:

• Food Ethics Council (2002) TRIPS with everything? www.foodethicscouncil.org
• Nuffield Council on Bioethics (2002) The ethics of patenting DNA.
• Commission on Intellectual Property Rights (2002) Integrating intellectual property rights and development policy.
• Stirling, A. (1998) Risk at a Turning Point?, Journal of Risk Research, 1(2): pp 97-110.
• Stirling, A. (1999a) 'On Science and Precaution in the Management of Technological Risk', EUR 19056 EN, Volume I, Seville:IPTS.
• Stirling, A. (1999b) 'On Precautionary and Science-Based Approaches to Risk Assessment and Environmental Appraisal, EUR 19056 EN Volume II, Seville:IPTS.
• Stirling, A and S. Mayer. (1999), 'Rethinking Risk: a pilot multi-criteria mapping of a genetically modified crop in agricultural systems in the UK', University of Sussex, UK: SPRU.
• Stirling, A. and S. Mayer. (2000) Precautionary approaches to the appraisal of risk: a case study of a genetically modified crop. International Journal of Occupational and Environmental Health 6, pp 296-311.
• Stirling, A & Mayer, S. (2001) Multi-criteria mapping the genetically modified crop debate: A pilot study of a genetically modified crop in the UK. Environment and Planning C: Environment and Planning C 19: 529-555.
• Mayer, S. & Stirling, A. (2002) Finding a precautionary approach to technological developments - lessons for the evaluation of GM crops. Journal of Agricultural and Environmental Ethics. Journal of Agricultural and Environmental Ethics 15 (1) 57-71.
• Levidow, L. and S. Carr (2000). UK: precautionary commercialisation? Journal of Risk Research 3 (3): pp 261-270.
• Parker, I.M. & Kareiva, P. (1996) Assessing the risks of invasion for genetically engineered plants: acceptable evidence and reasonable doubt. Biological Conservation 78: 193-293.

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