Skip to main content

The Federal Biotechnology Regulatory System: A Commentary on an Institutional Work in Progress

  • Chapter
Biotechnology and the Consumer

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.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 129.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  • Agriculture and Agri-Food Canada (1996). Biotechnology, agriculture and regulation. http://www.agr.ca/fpi/agbiotec/geninfo.html

    Google Scholar 

  • Ayres, I., & Braithwaite, J. (1992). Responsive regulation: Transcending the deregulation debate. Oxford: Oxford University Press.

    Google Scholar 

  • Baldwin, R. (1995). Rules and government. Oxford: Clarendon Press.

    Google Scholar 

  • 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.

    Google Scholar 

  • Breyer, S. (1993). Breaking the vicious circle: Towards effective risk regulation. Cambridge, MA: Harvard University Press.

    Google Scholar 

  • Chemical and Bio-Industries Branch (1996). Bioindustries. Draft, July 15. Ottawa: Industry Canada.

    Google Scholar 

  • 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.

    Google Scholar 

  • Dewees, D. (Ed.) (1983). The regulation of quality. Toronto: Butterworths.

    Google Scholar 

  • 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.

    Google Scholar 

  • Doern, G. B. (Ed.) (1978). The regulatory process in Canada. Toronto: MacMillan.

    Google Scholar 

  • Doern, G. B. (1981). Scientific controversy in federal policy formation. Ottawa: Science Council of Canada.

    Google Scholar 

  • Doern, G. B. (1994). The road to better public services: Progress and constraints in five federal agencies. Montreal: Institute for Research on Public Policy.

    Google Scholar 

  • Doern, G. B. (1995). Fairer play: Canadian competition policy institutions in a global market. Toronto: C. D. Howe Institute.

    Google Scholar 

  • 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.

    Google Scholar 

  • 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.

    Google Scholar 

  • Doern, G. B., & Conway, T. (1994). The greening of Canada. Toronto: University of Toronto Press.

    Google Scholar 

  • Doern, G. B., Pal, L., & Tomlin, B. (Eds.). (1996). Border crossings: The internationalization of Canadian public policy. Toronto: Oxford University Press Canada.

    Google Scholar 

  • Doern, G. B., & Wilks, S. (1998). Changing regulatory institutions in Britain and North America. Toronto: University of Toronto Press.

    Google Scholar 

  • Francis, J. (1993). The politics of regulation: A comparative perspective. Oxford: Blackwell.

    Google Scholar 

  • Grabosky, P. N. (1995). Using non-governmental resources to foster compliance. Governance, 8, 527–550.

    Article  Google Scholar 

  • Harris, R. A., & Milkis, S. M. (1989). The politics of regulatory change. New York: Oxford University Press.

    Google Scholar 

  • 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.

    Google Scholar 

  • Harrison, K. (1996). Passing the buck: Federalism and Canadian environmental policy. Vancouver: UBC Press.

    Google Scholar 

  • Harrison, K., & Hoberg, G. (1994). Risk, science and politics. Montreal: McGill-Queens University Press.

    Google Scholar 

  • Health and Welfare Canada (1991). Health protection and drug laws. Ottawa: Minister of Supply and Services.

    Google Scholar 

  • 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.

    Google Scholar 

  • Hoberg, G. (1993). Pluralism by design: Environmental policy and the American regulatory state. New York: Praeger.

    Google Scholar 

  • Hood, C. (1986). Administrative analysis. London: Harvester Wheatsheaf.

    Google Scholar 

  • Human Resources Developement Canada (1996). Road map for biotechnology regulations. Ottawa: Human Resources Development Canada.

    Google Scholar 

  • Hutter, B. M. (1989). Variations in regulatory enforcement styles. Law and Policy, 11, 153–174.

    Article  Google Scholar 

  • Jacobs, S. (1992). Regulatory management and reform: Current concerns in OECD countries. Paris: OECD.

    Google Scholar 

  • 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.

    Google Scholar 

  • Law Reform Commission (1986). Policy implementation, compliance and administrative law. Ottawa: Law Reform Commission of Canada.

    Google Scholar 

  • 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.

    Google Scholar 

  • 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.

    Google Scholar 

  • McGarity, T. O. (1991). Reinventing rationality: The role of regulatory analysis in the federal bureaucracy. Cambridge, MA: Harvard University Press.

    Book  Google Scholar 

  • Mehta, M. D. (Ed.) (1996). Regulatory efficiency and the role of risk assessment. Kingston: Queen’s University, School of Policy Studies.

    Google Scholar 

  • Meier, K. J. (1985). Regulation: Politics, bureaucracy, economics. New York: St. Martins.

    Google Scholar 

  • National Biotechnology Advisory Committee (1995). Improving Canadian biotechnology regulation: A study of the U.S. experience. Ottawa: National Biotechnology Advisory Committee.

    Google Scholar 

  • Office of Consumer Affairs (1996). Biotechnology: What is it all about? Consumers Quarterly, 1(3), 1–4. Ottawa: Industry Canada.

    Google Scholar 

  • Ogus, A. I. (1994). Regulation: Legal form and economic theory. Oxford: Clarendon.

    Google Scholar 

  • Pildes, R., & Sunstein, C. (1995). Reinventing the regulatory state. University of Chicago Law Journal, 62, 1–129.

    Article  Google Scholar 

  • Schultz, R., & Alexandroff, A. (1985). Economic regulation and the federal system. Toronto: University of Toronto Press.

    Google Scholar 

  • 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.

    Google Scholar 

  • Sheehy, H. (1996). Consumers and biotechnology: A synopsis of survey and focus group research. Ottawa: Industry Canada, Office of Consumer Affairs.

    Google Scholar 

  • Skogstad, G. (1987). The politics of agricultural policy making. Toronto: University of Toronto Press.

    Google Scholar 

  • Sparrow, M. K. (1994). Imposing duties: Government’s changing approach to compliance. London: Praeger.

    Google Scholar 

  • 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.

    Google Scholar 

  • Standing Committee on Agriculture and Agri-Food (1994). rbST in Canada. Issue No. 13. Ottawa: House of Commons.

    Google Scholar 

  • Standing Committee on Environment and Sustainable Development (1996). Evidence from Meeting No. 34, 2nd Session, 35th Parliament, October 1, 1996. Ottawa: House of Commons.

    Google Scholar 

  • Swimmer, G. (Ed.) (1996). How Ottawa spends 1995–1996: Life under the knife. Ottawa: Carleton University Press.

    Google Scholar 

  • Trebilcock, M., & Howse, R. (1995). The regulation of international trade. London: Routledge.

    Google Scholar 

Download references

Authors

Editor information

Bartha M. Knoppers Alan D. Mathios

Rights and permissions

Reprints and permissions

Copyright information

© 1998 Kluwer Academic Publishers

About this chapter

Cite this chapter

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

Download citation

  • DOI: https://doi.org/10.1007/978-1-4615-5311-3_11

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-7923-5541-0

  • Online ISBN: 978-1-4615-5311-3

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics