Completing the Biotechnology Regulatory Framework

Advisory Memorandum, PDF format, 44 KB

February 2004

Advisory Memorandum

The lack of a comprehensive regulatory system for products of biotechnology is impeding the development of niche industries in Canada and consequently the potential for consumer and economic benefits. Regulators are justifiably concerned about being able to apply the appropriate risk analysis to new applications of biotechnology. At the same time, Canadian firms need to know what the rules are so they can decide whether to invest in Canada or elsewhere. With respect to some of these emerging industries, such as plant molecular farming, Canada may already have missed the opportunity.

The Canadian Biotechnology Advisory Committee issues advisory memoranda to achieve the following objectives:

• to alert the Government of Canada on issues of immediate importance and provide recommendations to assist decision makers in developing an effective course of action
• to inform government of the "state of the debate" on topics that will likely require government attention in the short to medium term
• to report on the impact that government policy is having on biotechnological developments in Canada.

Context

Canada's current regulatory system for genetically modified (GM) and other novel organisms has been sufficient for the first generation of biotechnology products. Increasingly, however, new biotechnology products are being developed that do not fit neatly into existing categories, such as spider silk produced in goat's milk or pharmaceuticals produced by plants or animals.

While there has been extensive research activity in these areas in Canada, the regulatory system has not evolved to handle the risk analysis of the resulting products. For instance, while recent reviews of the GM food and feed regulatory systems by the Royal Society of Canada Expert Panel and CBAC have affirmed that science-based risk assessment, as incorporated in the Canadian regulatory framework, is appropriate, there is little evidence of government action to implement recommended improvements or to extend the system to other products (i.e., genetically engineered and transgenic animals and fish, cloned animals, functional foods and nutraceuticals, or novel protein production systems).

Canada is recognized as a world leader in many areas of agricultural biotechnology research, which is also one of our major exports. However, the lack of a comprehensive regulatory system for agricultural products of biotechnology has the potential both to undermine public confidence in the regulatory system and to impede the development of niche industries in Canada as well as the consumer and economic benefits that could result. Governments are justifiably concerned about issuing regulations without a clear understanding of the science involved in the new products and the potential impacts (whether positive or negative) they may have on human, animal and environmental health. At the same time, Canadian firms need to know what the regulatory requirements are in order to make their investment decisions on a timely basis.

If Canada does not act quickly, work on these biotechnology applications will not take place in Canada. As a result, Canadian business will lose opportunities, which will instead flow to other jurisdictions that have clear operating rules (e.g., the United States). This loss could jeopardize Canada's standing in the international debate about regulation as well as threaten our production and export of biotechnology products. In addition, Canadians would not gain the benefits of these new technologies and products, while the economic loss could ultimately stall other socially desired research and development in Canada.

Current Status

Biotechnology is being applied in a number of new ways that have the potential to create new risks in the food system and the environment. Canadian industry leads in the development of new applications. Examples include transgenic animals (Enviropig) and fish (AquAdvantage salmon and trout) ultimately intended as food sources, transgenic animals to produce industrial chemicals or therapeutic proteins (spider silk produced in the milk of Nexia goats, recombinant proteins produced in the semen of TGN Biotech pigs) and plant molecular farming (SemBioSys's pharmaceutical canola and safflower).

Five separate regulatory review and development processes are under way (see Table 1). While the extent of the effort is comprehensive, progress has not been realized according to schedule. Not one of these efforts has delivered even draft regulations, let alone operational regulatory provisions, according to the timelines originally set for each process. In fact, there seems to be a practice of simply extending the target dates to some never quite attainable date in the future.

Status of Regulation of Products of Biotechnology

Source: Government of Canada Action Plan http://www.hc-sc.gc.ca/english/protection/royalsociety/index.htm; Progress Reports http://www.hc-sc.gc.ca/english/protection/novel_foods.html in response to the report of the Royal Society Expert Panel.

Options

As with any policy area, the government has several options. It can choose not to act, to delay action or to act on its stated intentions. The first two options (not to act or to delay action) are risky.

Canada is the leading developer of many of these new products. We should also be leading the way in developing appropriate regulation. Our scientific community has the greatest potential to manage the safe introduction of these products. Yet our apparent inability to act disenfranchises us from the international management of our developments. Canada's standing in and contribution to the international debate about regulation could be jeopardized while our production and export of high-knowledge products could be threatened.

Ultimately, these delays in filling the gaps in the regulatory system threaten the research, development and commercialization in Canada of socially beneficial biotechnology.

Recommendations

1. The federal government should reaffirm its confidence in and commitment to the current scientifically based regulatory framework for genetically modified and other novel foods and feed. The framework remains appropriate and effective for assessing the current level of risks in the agri-food system. To be effective, this reaffirmation should occur by June 2004.
2. The federal government should signal its confidence in the system by formally and openly committing to implement by December 2004 the recommendations of both the RSC Expert Panel and CBAC on measures to strengthen and support the regulation of GM foods and feeds.
3. The federal government should, as quickly as possible, extend the biotechnology regulatory framework to other products of biotechnology (i.e., transgenic animals and fish, cloned animals, functional foods and nutraceuticals, and novel protein production systems). This should be completed by December 2004.
4. If the expertise and capacity are not currently in place to meet these deadlines, the federal government should correct this deficiency on a priority basis.