The topic outline specifies 2 key issues - how fine grained, chemical composition data can be used in risk assessment and whether GM has precise outcomes. In addition, to give further depth to the review, additional critical issues for the science review are:

• How robust is the theoretical underpinning of the GM food safety assessment system? The topic outline currently describes, and tends to defend, the present approach. A comprehensive scientific review must examine how robust this is and identify any areas of uncertainty.
• What are the limitations of chemical analysis in predicting biological function?
• What biological assessments are needed and what degree of certainty can be attached to outcomes?
• To what extent can differences be detected between GM and non-GM foods?
• What are the scientific quality controls that are needed? How many samples and replicates are acceptable? What spread of environmental conditions should crops be grown in? Should novel gene products be tested in isolation, in the food as it will be experienced or by both of these methods?
• In areas of uncertainty, what monitoring systems are needed to detect impacts and to what extent are these feasible? If they are not feasible what are the implications for individual and public health?
• What other elements of a control system are needed to allow an effective response if an unexpected adverse reaction is seen? For example, if allergic reactions to novel introduced proteins arise in a small number of people, this could be life-threatening for those individuals and they will need to find ways to avoid the risk. Given the uncertainties in the assessment of new allergens, what traceability and labelling schemes are necessary, from a scientific perspective, to protect any vulnerable people?
• Can antibiotic resistance marker genes be justified in scientific terms in light of the many other GM marker systems available and the ability to remove marker genes?
• How should GM crops used for the production of therapeutic or diagnostic proteins be kept separate from the food chain?

In relation to these and other issues identified in the topic overview, GeneWatch believe the documents considered should include:

• The Royal Society of Canada. Elements of Precaution: recommendations for the regulation of food biotechnology in Canada. January 2001.
• Millstone, E et al (1999) Beyond substantial equivalence. Nature 401: 526-527.
• Birch, A.N.E. et al (2002)The effect of genetic transformation for pest resistance on foliar solanidine-based glycoalkaloids of potato (Solanum tuberosum). Annals of Applied Biology 140: 143-149.
• Wilberg, E., et al. Fatty acid distribution and lipid metabolism in developing seeds of laurate-producing rape (Brassica napus L.). Planta 203: 341-348, 1997.
• Murphy, D.J., et al. Expression of unusual fatty acids in transgenic rapeseed causes induction of glyoxylate cycle genes. John Innes and Sainsbury Annual Report 1998/99. Pages 44-46. John Innes Centre: Norwich.
• Gura, T. Reaping the plant gene harvest. Nature 287: 412-414, 2000.
• Murphy, D.J. Production of novel oils in plants. Current Opinion in Biotechnology 10: 175-180, 1999
• Firn, R.D. & Jones, C.G. Secondary metabolism and the risks of GMOs. Nature 400:13-14, 1999.
• Nestle. M. Allergies to transgenic foods - questions of policy. The New England Journal of Medicine 334: 726-728, 1996.
• Nordlee, J.A. et al. Identification of a brazil-nut allergen in transgenic soybeans. The New England Journal of Medicine 334: 688-692, 1996.
• Murphy, DJ, Development of new oil crops in the 21st century, Inform 11, January 2000.
• Shrewmaker, CK, et al, Seed-specific overexpression of phytoene synthase: increase in carotenoids and other metabolic effects, The Plant Journal 20 (4), 401-412, 1999.
• Labra, M., et al (2001) Genomic changes in transgenic rice (Oryza sativa L.) plants produced by infecting calli with Agrobacterium tumefaciens. Plant Cell Reports, 20, 325-330.
• Shunhong Dai, et al (2001). Comparative analysis of transgenic rice plants obtained by Agrobacterium-mediated transformation and particle bombardment. Molecular Breeding 7: 25-33.
• Windels, P. et al (2001) Characterisation of the Roundup Ready soybean insert. European Food Research Technology, 213, 107-112.
• International Human Genome Sequencing Consortium (2001) Initial sequencing an analysis of the human genome. Nature 409: 860-921.
• Commoner, B. (2002) Unravelling the DNA myth. The spurious foundation of genetic engineering. Harper's Magazine, February. Available on www.mindfully.org/GE/GE4/DNA-Myth-CommonerFeb02.htm.
• Dennis, C. (2002) The brave new world of RNA. Nature, 418, pg. 1222-124 and related articles in Nature Insight -RNA, 11th July 2002.
• Inose, T. & Murata, K. (1995) Enhanced accumulation of toxic compound in yeast cells having high glycolytic activity: a case study on the safety of genetically engineered yeast. International Journal of Food Science and Technology, 30, 141-146.
• Fray, R.G., et al (1995) Constitutive expression of a fruit phytoene synthase gene in transgenic tomatoes causes dwarfism by redirecting metabolites from the gibberellin pathway. The Plant Journal, 8, 693-701.
• Gertz, J.M., Vencil, W.K. & Hill, N.S. (1999) Tolerance of transgenic soybean (Glycine max) to heat stress. The 1999 Brighton Conference. British Crop Protection Council: Farnham, Surrey. 8C-6 pp 835-840.
• Lappé, M.A. et al (1998/1999) Alterations in Clinically Important Phytoestrogens in Genetically Modified, Herbicide-Tolerant Soybeans. Journal of Medicinal Food, 1, 241-245.
• Submission of the British Medical Association to the Scottish Executive's Health and Community Care Committee on the Health Impact of GM Crop Trials.

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