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ARCHIVED - CEPA Annual Report for Period April 2005 to March 2006

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 the Canadian Environmental Protection Act, 1999 (CEPA 1999) respecting new substances which 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 Environment Canada to intervene by implementing a risk management process, placing restrictions on the organism, or prohibiting the organism from import or manufacture in Canada.

When Environment Canada and Health Canada 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, a Significant New Activity Notice is issued to ensure that adequate additional information is provided to the Minister 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.

The Canadian Environmental Protection Act, 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

Sixteen notifications were received from which:

  • Five New Substance Notifications were received and assessed. No risk management measures were deemed necessary.
  • Three were not assessed or were incomplete.
  • Seven notifications of living organisms regulated under theFood and Drugs Act were received and assessed. No risk management measurements were deemed necessary.
  • One Significant New Activity Notification was received and assessed. Risk management measures (conditions) were recommended to mitigate potential environmental/human health risks.

Supporting documents containing comprehensive pathogenicity/toxicity information from various sources (including the scientific literature) continue to be developed and updated for each of the Domestic Substances List microbial strains.

Different sectors (environmental, agricultural, industrial, etc.) in Canada use Domestic Substances List microbial strains; therefore information on use patterns has begun to be collected.

Proposed guidelines on prioritization, screening assessment, external review, and review of decisions from other jurisdictions on Domestic Substances List microbial strains are in development.

For risk management actions, see Table 9 below.

Table 9: Risk Management Actions
Part 6 of CEPA - New Substances Statistics: Notices of Ministerial
Substance NameChemical, Polymer or OrganismActionCanada Gazette Publication Date
Fusarium fungus species strain CK 46-8OrganismCondition11-Mar-06

Health Canada research also addresses micro-organisms and their by-products in the generation of essential scientific information for use in present and future assessments as well as risk management decisions. This led to the (i) updating of information critical for definitive micro-organism identification by advanced methodology (e.g. comparative genomics and proteomics to measure relatedness to clinical counterparts) and (ii) testing of the toxicity and immunologic effects of certain selective genera of which Acinetobacter, Bacillus, Pseudomonas are three examples. These three genera are pathogens and are applications of biotechnology. The completion of physical and chemical characterizations of 35 micro-organisms has led to prioritized animal testing. This scientific information is shared across the collaborative Biotechnology networks within the Government of Canada.

Environment Canada research addresses the need for data to complete screening level risk assessments for microbial substances on the Domestic Substances List. Data has been generated to assess the potential hazard posed by microbial substances to soil-dwelling organisms. To address this existing data gap, the Soil Toxicology Laboratory performed fate (persistence) and effect (pathogenicity and toxicity) testing on more than 20 bacterial and fungal microbial strains between 2003 and 2005; portions of this work were completed with the assistance of researchers at Carleton University. The pathogenicity and toxicity testing was conducted according to the new Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms (EPS 1/TM/44) published as part of the Biological Test Method Series in March 2004. The data generated through this project will assist the New Substances Branch with their risk assessment of Domestic Substances List-listed substances, an obligation under the Canadian Environmental Protection Act, 1999.

Table 10: Significant New Activity Notices Published in 2005-06
Part 6 of CEPA - New Substances Statistics: Significant New Activity Notices Published in 2005-06
Substance NameChemical, Polymer or OrganismActionCanada Gazette Publication Date
Fusarium fungus species strain CK 46-8OrganismRescinded SNAc11-Mar-06

 

6.2 Working Group on Harmonization of Regulatory Oversight in Biotechnology

The Organisation for Economic Co-operation and Development Working Group for the Harmonisation of Regulatory Oversight in Biotechnology met on 24-26 October 2005 in Paris. The working group completed work on a consensus document on Acidithiobacillus (a genus of bacteria important in mining). The working group also continues to work on a guidance document on the biology of Acinetobacter (another genus of bacteria), as well as providing feedback on the development of a consensus document on the biology of the Atlantic Salmon.