2.6 Part 6: animate products of biotechnology

The evaluation identified two expected outcomes for Part 6:

1. Releases of toxic or harmful animate products of biotechnology are prevented or reduced.
2. Unauthorized use of new animate products of biotechnology is prevented.

The Act establishes an assessment process for living organisms that are new animate products of biotechnology. This process mirrors the provisions in Part 5 respecting new substances that are chemicals or polymers.

For the purposes of this evaluation, this section of the report also considers departmental efforts with respect to the 35 biotechnology substances listed on the Domestic Substances List.

The evaluation found that all relevant Ministerial obligations are being satisfied.

Over the period 1997-2004, 140 notifications concerning new animate products of biotechnology were received by Environment Canada. The Department authorized manufacturing or importing with respect to 43 (30%) of these notifications. It did not provide authorization for the remaining 97 notifications, because the information provided was insufficient to make a determination.

For one biotechnology substance considered a "suspected toxic," Environment Canada worked with industry, resulting in the voluntary withdrawal of the notification. This prevented the manufacture and use of the substance.

Since 2000, the Governor in Council has listed five acts and regulations under the Canadian Environmental Protection Act (CEPA 1999) Schedule 4, indicating that those acts provide an equivalent notification and assessment process. These five acts and regulations are:

• Pest Control Products Act - Pest Control Products Regulations;
• Seeds Act - Seeds Regulations;
• Fertilizers Act - Fertilizers Regulations;
• Feeds Act - Feeds Regulations, 1983; and
• Health of Animals Act - Health of Animals Regulations.

The departments administering those acts are responsible for assessing new products of biotechnology relevant to those acts.

The Department also has concluded a memorandum of understanding with the Department of Fisheries and Oceans on the "assessment of aquatic organisms with novel traits" and another with Health Canada for animate products of biotechnology regulated under the Food and Drugs Act. Under the memoranda of understanding, these other departments have agreed to lead the assessment of certain animate products of biotechnology, even though the Fisheries Act and the Food and Drugs Act have not yet been added to Schedule 4.

Other departments have been slow to develop environmental regulations with respect to aquatic organisms, certain pharmaceuticals, food products and transgenic animals. As a result, Environment Canada has had to assume responsibility for assessing substances of biotechnology in those areas, even though it lacks both appropriate expertise and funding. The Department is responsible for assessing any novel substances of biotechnology that do not fit neatly into areas of responsibility of any other department.

In spite of efforts to promote compliance across Canada, alack of awareness among the regulated community of notification requirements has created difficulties for the Department in implementing its New Substances Program for animate products of biotechnology. For example,a significant percentage (70%) of submissions that the Department receives are rejected as incomplete. A consultation plan for the forthcoming New Substances Notification Regulations (Organisms) has been proposed, including an outreach and awareness component relating to animate products of biotechnology.

The Domestic Substances List includes 35 existing biotechnology substances. Protocols to facilitate the screening assessments of these substances are under development.

Research on ecosystem effects of "novel living organisms" remains unfunded. This was a need identified by the Royal Society of Canada and the Canadian Biotechnology Advisory Committee.

The need to increase transparency with respect to assessment protocols and other aspects of the biotechnology notification process, as identified in the 2001-02 Operational Review, remains outstanding.

The expected outcome of preventing and reducing releases of toxic or harmful products of biotechnology is being met in part, where notifications have been submitted.

It is not possible to determine whether the expected outcome of preventing unauthorized use of new animate products of biotechnology is being or will be achieved. Measurement and reporting systems capable of documenting progress towards this expected outcome are not currently in place.