Document(s) 13 of 14

The Canadian government has placed a high importance on ensuring that the regulatory system for products of biotechnology is in place. In 1993, the Federal Cabinet announced the Federal Regulatory Framework for Biotechnology. This framework contains six key principles that have served as guidance for the federal departments in developing regulatory changes, guidelines, and policies.

In Agriculture and Agri-Food Canada, guidelines have been developed this year that allow for the environmental release of canola, flax, potatoes, and corn. Four canola lines have been approved this year (two each produced using mutagenesis and genetic engineering) and 25 veterinary diagnostic kits have been registered to date.

Traditional Approach Components

Risk management and risk communication deal with costs and benefits. In general, there are few universally accepted standards to conduct risk management, and decisions tend to be based on a case-by-case basis.

Risk management is an important component of decision-making. This is the area where cost/benefit analysis and value judgements, based on factors such as economic implications, are made.

Trade realities also need to be considered, particularly for countries not as advanced in the development and regulation of products developed using new methods of biotechnology such as genetic engineering. More recently, there is increasing recognition that social, cultural, and ethical issues need to be taken into account in the making of risk management decisions.

Agriculture and Agri-Food Canada is in the initial stages of determining ways in which these factors can be taken into account in a transparent manner. To be credible, a process for public input may need to be developed. It is possible such a process would be triggered by key agreed-upon principles.

If such a process existed, rbST (recombinant bovine somatotropin) may not have prompted an intervention by the House of Commons Standing Committee on Agriculture and Agri-Food before Health Canada, the department responsible for reviewing the safety of rbST made a decision on whether to licence it for sale.

It is possible that the establishment of such a process may be a viable option to handle new products including those products through biotechnology. If the criteria chosen are reasonable, it is likely that very few products would ever even trigger such a system.

Overview of rbST in Canada

The rbST products from two manufacturers have been undergoing a review by Health Canada for their safety to animal and human health. As yet, Health Canada has not made a decision on the issuance of a Notice of Compliance, without which rbST cannot be licenced for commercial sale or use.

In February and March of 1994, the Standing Committee on Agriculture and Agri-Food consulted widely on rbST use in Canada. Hearings were conducted in response to a number of issues raised about the use of rbST. These hearings were independent from the safety review being undertaken by Health Canada. The result was a report outlining seven recommendations to the government.

The government responded to these recommendations by obtaining a commitment from the manufacturers to a one-year voluntary delay on the sale and use of rbST and by establishing a Task Force to collect and make available the information requested by the Standing Committee.

The Task Force oversaw the completion of four specific tasks:

• A review by my department of the costs and benefits for the Canadian dairy industry, including an estimate of the costs of a dual delivery system, with information provided by the manufacturers and other interested parties;

• A discussion paper on the safety of rbST to animal and human health, by Health Canada;

• A review of the impact of rbST on animal genetics by the Genetic Evaluation Board, manufacturers, and Agriculture and Agri-Food Canada; and

• Regular updates of U.S. consumer reactions to rbST by Industry Canada and Agriculture and Agri-Food Canada.

Reviewing potential socioeconomic impacts are not only occurring in Agriculture and Agri-Food Canada, but in the federal government as well. Early in 1995, the federal government produced a document entitled the "Jobs & Growth Agenda."

As part of commitments made to Canadians and the industry at large, the government stated that the regulations for products of biotechnology would be in place in 1995 and that a forum to address issues would be held.

The Socioeconomic Forum is seen as an ongoing process where the public and various organizations can share their perspectives on socioeconomic issues. The process envisioned to date, will likely include the release of a background document as a means of providing information and eliciting responses from interested parties.

This document will contain background information on what biotechnology and risk assessment are, the regulatory process for products of biotechnology, and an overview of broad categories of socioeconomic issues that could form the basis of the Socioeconomic Forum.

Socioeconomics is a difficult area to deal with because of the depth of issues involved, the difficulty in separating societal vs individual values, and the problem of dealing with public input in a meaningful way. Compounding these factors is the low level of awareness on what biotechnology is, how it will affect consumers, and the government's role.

Ultimately, a regulatory decision has to be made, and the objective scientific assessment will have to be balanced against a more subjective cost/benefit analysis in risk management.

Government is increasingly being called upon to regulate in the areas of new technological advances, such as biotechnology, to provide frameworks that will allow such products to be used safely for society's benefit. Hence, it is important that all sectors of the public have input into the process so that the policies and decisions made reflect the majority views.

Document(s) 13 of 14