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General principles for risk assessment of living modified organisms: Lessons from chemical risk assessment*

Published online by Cambridge University Press:  15 June 2003

Ryan A. Hill
Affiliation:
Biosafety Programme, Secretariat of the Convention on Biological Diversity, 393 St Jacques St, Suite 300, Montreal, Quebec, H2Y1N9 Canada
Cyrie Sendashonga
Affiliation:
Biosafety Programme, Secretariat of the Convention on Biological Diversity, 393 St Jacques St, Suite 300, Montreal, Quebec, H2Y1N9 Canada

Abstract

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Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the environment and human health. In addition, the Cartagena Protocol on Biosafety, an international agreement expected to enter into force in the near future, requires risk assessment as the basis for decision-making regarding import of some LMOs. While LMO risk assessment is relatively new, there are other risk assessment disciplines which have developed over longer time periods. The field of assessment of the environmental and human health risks of chemicals is particularly well developed, and is similar in application to LMO risk assessment. This paper aims to draw lessons for LMO risk assessment from the vast experience with chemical risk assessment. Seven general principles are outlined which should serve as a useful checklist to guide assessments of risks posed by LMOs.

Type
Research Article
Copyright
© ISBR, EDP Sciences, 2003

Footnotes

*

The views expressed in this paper are those of the authors and do not represent views of the Secretariat of the Convention on Biological Diversity or the Parties to the Convention.

References

Barnthouse, LW (1994) Issues in Ecological Risk Assessment: the CRAM Perspective. Risk Analysis 14: 251-256 CrossRef
Begley, R (1996) Risk-based remediation guidelines take hold. Environ. Sci. Technol. 30: 438A-441A CrossRef
Bogen, KT (1994) A note on compounded conservatism. Risk Analysis 14: 379-381 CrossRef
Burmaster, DE, Anderson, PD (1994) Principles of good practice for the use of Monte Carlo techniques in human health and ecological risk assessments. Risk Analysis 14: 477-481 CrossRef
Burmaster, DE, Harris, RH (1993) The magnitude of compounding conservatism in Superfund risk assessments. Risk Analysis 13: 131-134 CrossRef
CCME (Canadian Council of Ministers of the Environ- ment) (1996) A Framework for Ecological Risk Assessment: General Guidance. Prepared by the CCME Subcommittee on Environmental Quality Criteria for Contaminated Sites
CEC (Commission of the European Communities) (1996) Technical guidance documents in support of the Commission Directive 93/67/EEC on risk assessment for new substances and the Commission Regulation No. 1488/94 on risk assessment for existing substances. Brussels, Belgium
CFIA (Canadian Food Inspection Agency) (2001) Regula- tory Directive Dir94-08: Assessing Criteria for Determining Environmental Safety of Plants with Novel Traits. Plant Health and Production Division, Plant Biosafety Office
Chapman, P, Paine, MD, Arthur, AD, Taylor, LA (1996) A triad study of sediment quality associated with a major, relatively untreated marine sewage discharge. Marine Pollution Bulletin 32: 47-64 CrossRef
Clarkson, TW (1990) Human health risks from methylmercury in fish. Environ. Toxicol. Chem. 9: 957-961 CrossRef
Cullen, AC (1994) Measures of compounding conservatism in probabilistic risk assessment. Risk Analysis 14: 389-393 CrossRef
Cura, JJ (1998) Ecological risk assessment. Water Environ. Res. 70: 968-971 CrossRef
Dakins, ME, Toll, JE, Small, MJ (1994) Risk-based environmental remediation: decision framework and role of uncertainty. Environ. Toxicol. Chem. 13: 1907-1915 CrossRef
Dakins, ME, Toll, JE, Small, MJ, Brand, KP (1996) Risk-based environmental remediation: Bayesian Monte Carlo analysis and the expected value of sample information. Risk Analysis 16: 67-79 CrossRef
DEFRA (Department for Environment, Food and Rural Affairs) (2000) Guidelines for Environmental Risk Assessment and Management - Revised Departmental Guidance. United Kingdom
DETR (Department of the Environment, Transport and Regions) (1999) Guidance on principles for risk assessment and monitoring for the release of genetically modified organisms. DETR/ACRE guidance note 12, London, UK
EC (European Commission) (1998) Quantitative Environ- mental Risk Assessment for Genetically Modified Organ- isms. Institute for Health and Consumer Protection
EC (European Community) (2001) Directive 2001/18/EC of the European Parliament and of the Council, on the deliberate release into the environment of genetically modified organisms, 12 March 2001
EC (European Commission) (2002) 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
Edmonds Institute (1998) Manual for Assessing Ecological and Human Health Effects of Genetically Engineered Organisms. Prepared by the Scientists' Working Group on Biosafety
Ellison, AM (1996) An introduction to Bayesian inference for ecological research and environmental decision-making. Ecol. Appl. 6: 1036-1046 CrossRef
EPA (Environmental Protection Agency) (1997) Guidance on Cumulative Risk Assessment. Part 1. Planning and Scoping, Science Policy Council, EPA, Washington, D.C.
EPA (Environmental Protection Agency) (1998) Guidelines for Ecological Risk Assessment. EPA 630/R-95-002F, Washington, D.C.
ERMA (Environmental Risk Management Authority) (1999) Identifying risks for applications under the Hazardous Substances and New Organisms Act 1996, ER-TG-01-1 9/99, New Zealand
ERMA (Environmental Risk Management Authority) (2000a) Preparing information on risks, costs and benefits for applications under the Hazardous Substances and New Organisms Act 1996, ER-TG-03-1 7/00, New Zealand
ERMA (Environmental Risk Management Authority) (2000b) Assessment of effects of hazardous substances and new organisms on human health, ER-TG-02-1 1/00, New Zealand
Fiksel JR, Covello VT (1986) The suitability and applicability of risk assessment methods for environmental applications of biotechnology. In Fiksel JR, Covello VT, eds, Biotechnology Risk Assessment - Issues and Methods for Environmental Introductions. Permagon Press, pp 1-34
Finkel AM (1990) Confronting Uncertainty in Risk Management. Center for Risk Management, Resources for the Future, 1616 P Street, N.W., Washington, D.C.
Finkel, AM (1994) Risk assessment research: only the beginning. Risk Analysis 14: 907-911 CrossRef
Finley, B, Paustenbach, D (1994) The benefits of probabilistic exposure assessment: three case studies involving contaminated air, water and soil. Risk Analysis 14: 53-73 CrossRef
Francis, RICC (1992) Use of risk analysis to assess fishery management strategies: a case study using orange roughy on the Chatham Rise, New Zealand. Can. J. Fish. Aquat. Sci. 49: 922-930 CrossRef
Gaylor, DW, Chen, JJ, Sheehan, DM (1993) Uncertainty in cancer risk assessments. Risk Analysis 13: 149-154 CrossRef
Hamilton, JT, Viscusi, WK (1994) Human health risk assessments for Superfund. Ecol. Law Q. 21: 573-610
Harvey, T, Mahaffey, KR, Velazquez, S, Dourson, M (1995) Holistic risk assessment: an emerging process for environ- mental decisions. Regul. Toxicol. Pharmacol. 22: 110-117 CrossRef
Hill, RA (1996) From science to decision-making: the applicability of Bayesian methods to risk assessment. Human Ecol. Risk Assess. 2: 636-642 CrossRef
Hill, RA, Chapman, PM, Mann, GS, Lawrence, GS (2000) Level of detail in ecological risk assessments. Mar. Pollut. Bull. 40: 471-477 CrossRef
Ingersoll CG, Dillon T, Biddinger GR (1997) Ecological Risk Assessment of Contaminated Sediments. SETAC Press, Pensacola, FL, USA
Kappeli, O, Auberson, L (1998) How safe is safe enough in plant genetic engineering? Trends Plant Sci. 3: 276-281 CrossRef
Kjaer C, Damgaard C, Kjellsson G, Strandberg B, Strandberg M (1999) Ecological risk assessment of genetically modified higher plants - identification of data needs. NERI Technical Report No. 303. Ministry of Environment and Energy, National Environmental Research Institute, Denmark
Kjellsson G (1997) Principles and procedures for ecological risk assessment of transgenic plants. In Kjellsson G, Simonsen V, Ammann K, eds, Methods for Risk Assessment of Transgenic Plants II - Pollination, Gene-Transfer and Population Impacts. Birkhauser Verlag, Basel, Switzerland, pp 221-236
Maguire LA (1991) Risk analysis for conservation biologists. Conserv. Biol. 5: 123-125
Mathes K, Winter G (1993) Ecological risk assessment and the regulation of chemicals: 3. Balancing risks and benefits. Sci. Total Environ., supplement 1993: 1679-1687
McCarty, LS (1997) Environmental risk assessment within a decision making framework. Environ. Toxicol. Chem. 16: 122-123 CrossRef
McKone, TE, Bogen, KT (1991) Predicting the uncertainties in risk assessment. Environ. Sci. Technol. 25: 1674-1681 CrossRef
Menzie, C, Henning, MH, Cura, J, Findelstein, K, Gentile, J, Maughan, M, Metchell, D, Petron, S, Potocki, B, Sversky, S, Tyler, P (1996) Special report of the Massachusetts weight- of-evidence workgroup: a weight-of-evidence approach for evaluating ecological risk. Human Ecol. Risk Assess. 2: 277-304 CrossRef
Miller LM, Kapuscinski AR, Senanan W (2002) A biosafety approach to addressing risks posed by aquaculture escapees. Proceedings of the Expert Consultation on Biosafety and Environmental Impact of Genetic Enhancement and Introduction of Improved Tilapia Strains/Alien Species in Africa, 20-23 February 2002, Nairobi, Kenya. Published by the International Centre for Living Aquatic Resources Management (ICLARM)
Morgan MG, Henrion M (1990) Uncertainty - A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis. Cambridge University Press
Nickson TE, McKee MJ (2002) Ecological assessment of crops derived through biotechnology. In Thomas JA, Fuchs FL, eds, Biotechnology and Safety Assessment, 3rd edn. Academic Press, pp 233-252
North DW, Balson WE (1985) Risk assessment and acid rain policy: a decision framework that includes uncertainty. In Mandelbaumn P, ed, Proceedings of the conference Acid Rain: Economic Assessment. Plenum Press, New York
NRC (National Research Council) (1983) Risk Assessment in the Federal Government: Managing the Process. National Academy Press, Washington, D.C.
NRC (National Research Council) (1993) Issues in Risk Assessment. Committee on Risk Assessment Methodology, National Research Council. National Academy Press, Washington, D.C.
NRC (National Research Council) (1996) Understanding Risk - Informing Decisions in a Democratic Society. Committee on Risk Assessment Methodology, National Research Council. National Academy Press, Washington, D.C.
NRC (National Research Council) (2002) Environmental Effects of Transgenic Plants - the Scope and Adequacy of Regulation. Committee on Risk Assessment Methodology, National Research Council, National Academy Press. Washington, D.C.
OGTR (Office of the Gene Technology Regulator) (2001) Risk assessment framework for license applications to the office of the gene technology regulator, Canberra, Australia
OSTP (Office of Science and Technology Policy) (2001) Case Studies of Environmental Regulations for Biotechnology, Executive Office of the President, United States of America, Washington, D.C.
PCT (Pew Charitable Trust) (2002) Three years later: Genetically engineered corn and the monarch butterfly controversy. Issue Brief, Pew Initiative on Food and Biotechnology. Document available free of charge at http:// www.pewtrusts.com
Peterman, RM (1990) Statistical power analysis can improve fisheries research and management. Can. J. Fish. Aquat. Sci. 47: 2-15 CrossRef
Power, M, McCarty, LS (1997) Fallacies in ecological risk assessment practices. Environ. Sci. Technol. 31: 370A-375A CrossRef
Punt, AE, Hilborn, R (1997) Fisheries stock assessment and decision analysis: the Bayesian approach. Rev. Fish Biol. Fish. 7: 35-63 CrossRef
Reckhow, KH (1994) Importance of Scientific Uncertainty in Decision Making. Environ. Manage. 18: 161-166 CrossRef
Sears, MK, Hellmich, RL, Stanley-Horn, DE, Oberhauser, KS, Pleasants, JM, Mattila, HR, Siegfried, BD, Dively, GP (2001) Impact of Bt corn pollen on monarch butterfly populations: a risk assessment. PNAS 98: 11937-11942 CrossRef
Strandberg, B, Kjellsson, G, Lokke, H (1998) Hierarchical risk assessment of transgenic plants: proposal for an integrated system. Biosafety J. 4: 21
Strauss HS (1991) Lessons from chemical risk assessment. In Levin MA, Strauss HS, eds, Risk Assessment in Genetic Engineering. McGraw-Hill Inc, New York, pp 297-318
Suter GW II (1990) Uncertainty in Environmental Risk Assessment. In Furstenberg GM, ed, Acting Under Uncer- tainty: Multidisciplinary Conceptions. Kluwer Academic Publishers, pp 203-230
Suter GW II (1993) Ecological Risk Assessment. Lewis Publishers, Boca Raton
Thompson, GG (1992) A Bayesian approach to management advice when stock-recruitment parameters are uncertain. Fish. Bull. 90: 561-573
UNEP (United Nations Environment Program) (1995) UNEP International Technical Guidelines for Safety in Biotechnology
Vatter PA, Bradley SP, Frey Jr SP, Jackson BB (1978) Quantitative Methods in Management: Text and Cases. Richard D. Irwin, Inc., Illinois
Walters CJ (1986) Adaptive Management of Renewable Resources. Blackburn Press