Long awaited CBAC report on genetically modified foods pushes for tighter regulation, more resources and greater coordination

Guest Contributor
September 24, 2001

The federal government should consider tightening up regulations governing early-stage R&D of genetically modified (GM) foods and provide assistance to industry in identifying best practices. The recommendations are part of a wide ranging new interim report by the Canadian Biotechnology Advisory Council (CBAC) that provides the basis for a new round of consultation. Much of the initial reaction has focused on the report’s stand on the labelling of GM foods (it recommends beginning with a voluntary approach), with accusations of industry bias which are difficult to reconcile given the composition of the 20-person Committee.

The report’s more substantive content entails proposed changes to governance and the need for substantial investment to enhance and coordinate the existing regulatory framework to deal with the increasing complexity of the next generation of GM foods. CBAC also floats the idea of creating a chief safety officer for GM and other novel foods. The officer would coordinate the activities of the various regulatory bodies using a single national standard and to speak for the government on relevant environmental and health matters.

Also recommended is a new committee at the assistant deputy minister (ADM) level, with responsibility for a variety of activities including evaluation of the adequacy of existing guidelines for experimentation of recombinant DNA and other types of genetic modification.

Entitled Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada, the report focuses on science of GM foods mainly as it pertains to organization and regulation. The CBAC was originally going to take a much wider approach, but decided to narrow its focus in deference to a Royal Society of Canada (RSC) expert panel that honed in on science capacity in considerable detail (R$, March 5/01).

“People will now have a chance to take a crack at the recommendations. It’s a good way of testing their validity,” says Dr Arnold Naimark, CBAC chair and director of the Univ of Manitoba’s Centre for the Advancement of Medicine. “I hope that people will let us know what they think, and that the final submission is well supported. Our intention is to indicate the direction of thinking without spelling out quantitative goals. We also hope to get a reaction from the regulatory bodies.”

The document presents 10 issues (see chart) which it asserts are at the heart of its analysis. It also advances 24 recommendations which are broken into five general areas: good governance, evaluation of long-term health and environmental impacts, transparency, information and choice, and social and ethical considerations. Originally slated for release last June, the clock is now ticking on a six-month period of consultation and re-drafting. It will then be formally presented to government in early 2002 through the Canada Biotechnology Ministerial Coordinating Committee, comprised of ministers representing industry, agriculture, health, environment, fisheries and oceans, natural resources and international trade.

“Currently in Canada, neither the regulatory system nor the voluntary CIHR guidelines specifically provide standards covering greenhouse propagation of GM crops. The first point of contact with the regulatory system is upon application to grow GM crops out-of-doors in confined field tests.” — CBAC Report

Canada has not formulated new regulatory standards for GM and other novel foods. Instead, it has relied on existing legislation with coordination between Health Canada, the Canadian Food Inspection Agency (CFIA) and Environment Canada, while Health Canada and CFIA share responsibility for policies governing food labelling. Naimark contends that a single standard with a chief safety officer at the helm would greatly improve government’s ability to address the concerns of those who wish to be reassured that GM foods are safe.

Major GM Issues
  1. Transparency
  2. Separation & independence of regulatory functions
  3. Ensuring safety during R&D activities
  4. Opportunities for public involvement
  5. Post-market monitoring for risks and benefits
  6. Capability & capacity in the regulatory system
  7. Information provision
  8. Labelling
  9. Environmental stewardship
  10. Broader social & ethical considerations

“The pace of discovery and technological innovation is increasing rapidly and we will need new resources to respond to the increased load and allow more prompt reaction than in the past,” he says “A single national standard would be an important potential development and it’s the goal we should be aiming for. The question is, how do we get there?”

REACTION SPLIT

Naimark says initial reaction to the report has split fairly evenly into two camps, with those in opposition loosely gathered around a handful of non governmental organizations (NGOs). He adds that the groups now denouncing the report as biased towards industry are the same that declined to partici-pate in the round table discussions held earlier this year.

“The NGOs arrived at a conclusion about CBAC before the report came out and that led them to boycott the round tables. They saw us as biased towards industry and I repudiate that completely,” he says. “Their lack of participation was disappointed but not surprising. They missed an opportunity to participate in a dialogue with other groups although I hope they will participate fully in future rounds of discussion.”

With its GM foods study near completion, CBAC is set to begin a selection process to determine its future course of action. Among the back burner issues to be examined are: genetic privacy, development of an ethical framework for biotechnology, analysis of the science base for biotechnology, pharmacogenomics, and follow-up to previous work on intellectual property. Naimark says the selection process for the next issue should take 60-90 days beginning with its next meeting on September 20. Government will also be consulted to see whether there are any issues it would like to examine.

R$


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