Abstract
The authors describe and assess key institutional aspects of the Canadian federal biotechnology regulatory framework. Noting that Canada’s system for regulating biotechnology relies on five federal departments playing a substantive role, the authors explore how Canada’s system addresses central features of normally functioning regulatory systems and how it interacts with the macro regulatory environment. From these discussions it is shown that each of the departments involved in regulating biotechnology applications in Canada have very different approaches which are, in many respects, sensible and supportable. However, the paper concludes, further work needs to be done in order to secure the confidence of a wide-range of interests, noting especially, that the current system has not established an arena in which ethical issues can be addressed.
G. Bruce Doern is a Professor, School of Public Administration and Carleton Research Unit on Innovation, Science and Environment, Carleton University, E-mail: bdoern@ccs.carleton.ca. Heather Sheehy is a policy analyst at Health Canada, P.L. 3007A, Holland Cross, Tower A, Suite 709, Ottawa, Ontario, K1A 0K9. E-mail: heather_sheehy@hc-sc.gc.ca. At the time of writing she was with the Office of Consumer Affairs, Industry Canada.
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References
Agriculture and Agri-Food Canada (1996). Biotechnology, agriculture and regulation. http://www.agr.ca/fpi/agbiotec/geninfo.html
Ayres, I., & Braithwaite, J. (1992). Responsive regulation: Transcending the deregulation debate. Oxford: Oxford University Press.
Baldwin, R. (1995). Rules and government. Oxford: Clarendon Press.
Biotechnology regulation in Canada: A matter of public confidence (1996). Third Report to the Standing Committee on Environment and Sustainable Development, November. Ottawa: House of Commons.
Breyer, S. (1993). Breaking the vicious circle: Towards effective risk regulation. Cambridge, MA: Harvard University Press.
Chemical and Bio-Industries Branch (1996). Bioindustries. Draft, July 15. Ottawa: Industry Canada.
Department of Fisheries and Oceans (1996). Transgenic aquatic organisms: Policy and guidelines for research with, or for rearing in natural aquatic ecosystems in Canada. Draft. Ottawa: Department of Fisheries and Oceans, Aquaculture and Oceans Science Branch.
Dewees, D. (Ed.) (1983). The regulation of quality. Toronto: Butterworths.
Doering, R. L. (1996). Alternative service delivery: The case of the Canadian food inspection agency. Paper presented to the Department of Justice Workshop on Alternative Service Delivery, Ottawa, November 25.
Doern, G. B. (Ed.) (1978). The regulatory process in Canada. Toronto: MacMillan.
Doern, G. B. (1981). Scientific controversy in federal policy formation. Ottawa: Science Council of Canada.
Doern, G. B. (1994). The road to better public services: Progress and constraints in five federal agencies. Montreal: Institute for Research on Public Policy.
Doern, G. B. (1995). Fairer play: Canadian competition policy institutions in a global market. Toronto: C. D. Howe Institute.
Doern, G. B. (1998). The interplay among regimes: Mapping regulatory institutions in the UK, US, and Canada. In: G. B. Doern & S. Wilks (Eds.), Changing regulatory institutions in Britain and North America, pp. 29–50. Toronto: University of Toronto Press.
Doern, G. B. (forthcoming). Institutional and public administrative aspects of regulation versus voluntary codes. In: D. Cohen & K. Webb (Eds.), The role of voluntary codes. Ottawa: Government of Canada.
Doern, G. B., & Conway, T. (1994). The greening of Canada. Toronto: University of Toronto Press.
Doern, G. B., Pal, L., & Tomlin, B. (Eds.). (1996). Border crossings: The internationalization of Canadian public policy. Toronto: Oxford University Press Canada.
Doern, G. B., & Wilks, S. (1998). Changing regulatory institutions in Britain and North America. Toronto: University of Toronto Press.
Francis, J. (1993). The politics of regulation: A comparative perspective. Oxford: Blackwell.
Grabosky, P. N. (1995). Using non-governmental resources to foster compliance. Governance, 8, 527–550.
Harris, R. A., & Milkis, S. M. (1989). The politics of regulatory change. New York: Oxford University Press.
Harrison, K. (1994). Prospects for intergovernmental harmonization in environmental policy. In: D. Brown & J. Hiebert (Eds.), Canada: The state of the federation 1994, pp. 68–87. Kingston: Institute of Intergovernmental Relations.
Harrison, K. (1996). Passing the buck: Federalism and Canadian environmental policy. Vancouver: UBC Press.
Harrison, K., & Hoberg, G. (1994). Risk, science and politics. Montreal: McGill-Queens University Press.
Health and Welfare Canada (1991). Health protection and drug laws. Ottawa: Minister of Supply and Services.
Hill, M. (1994). The choice of mode for regulation: A case study of the Canadian pesticide registration review 1988–1992. Ottawa: Carleton University, Department of Political Science. Unpublished doctoral thesis.
Hoberg, G. (1993). Pluralism by design: Environmental policy and the American regulatory state. New York: Praeger.
Hood, C. (1986). Administrative analysis. London: Harvester Wheatsheaf.
Human Resources Developement Canada (1996). Road map for biotechnology regulations. Ottawa: Human Resources Development Canada.
Hutter, B. M. (1989). Variations in regulatory enforcement styles. Law and Policy, 11, 153–174.
Jacobs, S. (1992). Regulatory management and reform: Current concerns in OECD countries. Paris: OECD.
KPMG (1995). Improving Canadian biotechnology regulation: A study of the U.S. experience. Prepared for the National Biotechnology Advisory Committee on the Chemicals and Bio-Industries Branch. Ottawa: Industry Canada.
Law Reform Commission (1986). Policy implementation, compliance and administrative law. Ottawa: Law Reform Commission of Canada.
Martin, J. K. (1995). Regulating the regulators: The Canadian approach to implementing government-wide regulatory reform strategies. Paper presented to the New South Wales Regulatory Review Conference, Sydney, Australia, June 20.
Mausberg, B., Winfield, M., et al. (1993). Growing safety concerns about biotechnology and the regulatory process: A report to Agriculture Canada. Ottawa: Canadian Environment Network Biotechnology Caucus.
McGarity, T. O. (1991). Reinventing rationality: The role of regulatory analysis in the federal bureaucracy. Cambridge, MA: Harvard University Press.
Mehta, M. D. (Ed.) (1996). Regulatory efficiency and the role of risk assessment. Kingston: Queen’s University, School of Policy Studies.
Meier, K. J. (1985). Regulation: Politics, bureaucracy, economics. New York: St. Martins.
National Biotechnology Advisory Committee (1995). Improving Canadian biotechnology regulation: A study of the U.S. experience. Ottawa: National Biotechnology Advisory Committee.
Office of Consumer Affairs (1996). Biotechnology: What is it all about? Consumers Quarterly, 1(3), 1–4. Ottawa: Industry Canada.
Ogus, A. I. (1994). Regulation: Legal form and economic theory. Oxford: Clarendon.
Pildes, R., & Sunstein, C. (1995). Reinventing the regulatory state. University of Chicago Law Journal, 62, 1–129.
Schultz, R., & Alexandroff, A. (1985). Economic regulation and the federal system. Toronto: University of Toronto Press.
Schultz, R., & Doern, G. B. (1998). Canadian sectoral regulatory institutions in a North American context: No longer “governments in miniature.” In: G. B. Doern & S. Wilks (Eds.), Changing regulatory institutions in Britain and North America, pp. 108–130. Toronto: University of Toronto Press.
Sheehy, H. (1996). Consumers and biotechnology: A synopsis of survey and focus group research. Ottawa: Industry Canada, Office of Consumer Affairs.
Skogstad, G. (1987). The politics of agricultural policy making. Toronto: University of Toronto Press.
Sparrow, M. K. (1994). Imposing duties: Government’s changing approach to compliance. London: Praeger.
Stanbury, W. T. (1992). Reforming the federal regulatory process in Canada, 1971–1992. Published as Appendix to House of Commons, Standing Committee on Finance, Sub-committee on Regulations and Competitiveness. Issue No. 23, Ch. 5. Ottawa: Supply and Services Canada.
Standing Committee on Agriculture and Agri-Food (1994). rbST in Canada. Issue No. 13. Ottawa: House of Commons.
Standing Committee on Environment and Sustainable Development (1996). Evidence from Meeting No. 34, 2nd Session, 35th Parliament, October 1, 1996. Ottawa: House of Commons.
Swimmer, G. (Ed.) (1996). How Ottawa spends 1995–1996: Life under the knife. Ottawa: Carleton University Press.
Trebilcock, M., & Howse, R. (1995). The regulation of international trade. London: Routledge.
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Doern, G.B., Sheehy, H. (1998). The Federal Biotechnology Regulatory System: A Commentary on an Institutional Work in Progress. In: Knoppers, B.M., Mathios, A.D. (eds) Biotechnology and the Consumer. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-5311-3_11
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DOI: https://doi.org/10.1007/978-1-4615-5311-3_11
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