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ARCHIVED - A Guide to the Canadian Environmental Protection Act, 1999 March 2000

Part 6: Animate Products of Biotechnology (Sections 104 - 115)

These sections establish an assessment process for new animate products of biotechnology (such as living organisms) that mirrors provisions in Part 5 respecting new substances that are chemicals. Inanimate products of biotechnology will continue to be dealt with as "substances" under Part 5.

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;
  • the prescribed fee has been paid; and
  • the period for assessing the information has expired.

In certain circumstances, manufacturers and importers must also report "significant new activities" involving living organisms already approved, so that they can be re-evaluated.

The Minister has the ability to waive some or all of the information requirements if:

  • such information is not needed to assess the living organism;
  • the living organism can be contained in a way that protects the environment and human health; or
  • it is not practical or feasible to obtain the test data.

This is intended to prevent unnecessary information gathering. These waivers do not remove the Ministers' responsibility to determine that a new living organism is safe. All waivers must be published in the Canada Gazette and the Environmental Registry.

The requirements for notification and assessment in CEPA 1999 do not apply if the new living organism is manufactured or imported for a use that is regulated under another Act of Parliament that requires notice and assessment. The Governor in Council is responsible for determining if another Act meets these requirements, and for placing it on Schedule 4 of the CEPA 1999. Proposals to schedule an Act must undergo a 60-day public comment period.

The Governor in Council may make regulations to implement international agreements and regarding the safe use of living organisms in pollution prevention.

CEPA 1999 cannot be used to regulate an aspect of a living organism that is regulated under another Act in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health.

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