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ARCHIVED - CEPA Annual Report for Period April 2004 to March 2005

6. Animate Products of Biotechnology

The Act establishes an assessment process for living organisms that are new animate products of biotechnology that mirrors provisions in Part 5 of CEPA 1999 respecting new substances that are chemicals or polymers. Animate products of biotechnology may pose several potential risks to the environment, including possible impacts on natural biodiversity. They may introduce toxins, interfere with naturally occurring plants and animals, and harm natural genetic diversity.

Living organisms that are not on the Domestic Substances List are considered to be new. These cannot be used, manufactured, or imported until:

  • the Minister has been notified;
  • relevant information needed for an assessment has been provided by the applicant; and
  • the period for assessing the information has expired.

When the assessment process identifies a living organism that may pose a risk to human health or the environment, the Act empowers the Minister of the Environment to intervene by implementing a risk management process, placing restrictions on the organism, or prohibiting the organism from import or manufacture in Canada.

When the Ministers of the Environment and Health suspect that a significant new activity in relation to a living organism that had been previously assessed and found not to be toxic may result in the organism becoming toxic they may issue, a Significant New Activity Notice to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import, or use the organism for activities not specified by the notice. The additional information allows Environment Canada and Health Canada to assess the potential environmental and human health risks associated with the new activities.

CEPA 1999 requirements apply to new living organisms that are manufactured or imported unless other applicable Acts provide for notice and assessment and are specifically identified on Schedule 4 of the Act.

6.1 Risk Assessment and Management

In 2004-05, the New Substances Program received three new substance notifications and no significant new activity notifications. Two notifications were rejected, and one was completed. There were no risk management measures taken. One Significant New Activity Notice was issued (see Table 9).


Table 9: Significant New Activity Notices Published during 2004-05
Significant new activity
Canada Gazette publication date*
Fungus Fusarium species strain CK 46-8

any activity other than the

  1. use of the living organism within a contained facility, the latter as defined in subsection 2(1) of the New Substances Notification Regulations, in the production of a metabolite to be used as starting material for the production of a veterinary drug;
  2. filtration through 0.2 micron filters of all gaseous wastes and disinfection of the filters to destroy 99.999% of the living organism;
  3. disinfection of all liquid and solid wastes to destroy 99.999% of the living organism prior to transport and incineration of these wastes, as set out in paragraphs (d) and (e);
  4. transportation of all disinfected liquid and solid wastes to the incineration facility using a conveyance, as defined in section 216 of the Act, constructed or equipped to contain leaks, spills, or other such releases during transport; or
  5. incineration of all disinfected liquid and solid wastes, at no less than 900°C, by a facility authorized by the laws, regulations, and other requirements of the jurisdiction where the incineration will take place.
April 10, 2005

* As of this date, the Significant New Activity Notice will only allow importation, manufacture, and use of the substance for the activities proposed in the table.

6.2 International Actions

6.2.1 Working Group on Harmonization of Regulatory Oversight in Biotechnology

This working group under the OECD ensures that environmental, human health, and safety aspects of products of biotechnology are properly evaluated while avoiding non-tariff trade barriers to these products. The working group met in June 2004 and February 2005 to discuss areas where members can work together to develop consensus documents on bacteria, fungi, crop plants, environmental assessment parameters, and risk assessment of transgenic fish.


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