Animals > Biotechnology > Consultations (2004)  

CFIA Consultation on Animal Biotechnology - 2004

February 26-27, 2004

Executive Summary

The goals of the meeting were to

• continue consultations with stakeholders and regulated parties in order to proceed further in the implementation of the recommendations from the Animal Biotechnology Focus Group Meeting, held in March 2003,
• receive input and guidance on current issues facing the Animal Biotechnology Unit (ABU), and
• advance toward the development of the animal biotechnology regulatory framework for Canada.

The meeting was attended by representatives of industry, university scientists, representatives of interest groups, and federal government personnel involved in regulation of animal biotechnology. The meeting was also attended by a representative of the US FDA Center for Veterinary Medicine.

Opening of the Consultation by the National Manager of the CFIA Veterinary Biologics Section, Dr. Gifford, was followed by two presentations by University of Guelph scientists that dealt with assisted reproductive technologies and gene transfer.

An ‘Overview of Activities and Plans of the CFIA Animal Biotechnology Unit (ABU), and Progress Report on the Recommendations from the 2003 Animal Biotechnology Focus Group Meeting’, presented by Dr.Gifford, was followed by a brief conceptual outline of possible amendments to the Health of Animals Act and Regulations, concerning animal biotechnology, presented by Dr. Adlakha-Hutcheon of the ABU.

An overview of the draft ‘Notification Guidelines for the Environmental Assessment of Biotechnology - Derived Livestock Animals’, presented by Dr. Kochhar of the ABU, was illustrated by a case study communicated by Dr. Moreau of the CFIA Risk Assessment Unit.

In the subsequent discussion of the draft Guidelines the participants

• expressed appreciation of the progress made by the ABU since the 2003 meeting,
• pointed out possible problems with the notification requirements,
• discussed pre-assessment evaluation of biotechnology-derived animals,
• dealt with potential self regulation by the industry,
• discussed regulation of various types of biotechnology-derived animals and animals used in their creation, and
• commented on international aspects of animal biotechnology regulation, intellectual property rights, and animal welfare.

Where appropriate, government regulatory staff provided explanations, clarifications and opinions relevant to the points raised in the discussion.

The ‘Cloning Issue Identification Document’ was introduced by Mr. Bourbonniere of Health Canada. The document, compiled by the Interdepartmental Working Group on Animal Biotechnology, identifies possible issues and problems associated with animal cloning as a basis for decisions on regulation of animal cloning in Canada.

The theme of the second day of the Consultation was tracking of biotechnology-derived animals:

• Dr. Robertson of Clarkston Canada presented, on behalf of his Company and the Canadian Cattle Identification Agency, a review of the current status of animal tracking in Canada and future plans,
• Mr. Trus of Agriculture and Agri-Food Canada presented a review of a potential system for tracking based on the Animal Pedigree Act,
• a summary of a trial that tested tracking of pork using DNA markers was given by Mr. Morris of CFIA, and
• Dr. Gavora, Consultant and Scientific Advisor to the CFIA Animal Biotechnology Unit, compared two potential tracking systems based on the Animal Pedigree Act, and the Health of Animals Act and Regulations, concluding that the systems would be complementary and compatible.

Subsequent discussion of tracking of biotechnology-derived animals

• emphasized the importance of coordination and alignment of possible multiple tracking systems,
• showed a need for regulatory redefinition of ‘an animal’, particularly the inclusion in the definition of reproductive and somatic cells and cell lines,
• indicated the need for clarification of the differentiation among categories within biotechnology-derived animals, animals used in their production (e.g. surrogate mothers), and conventional animals,
• demonstrated the relevance of safety and security aspects of biotechnology-derived animals,
• clarified aspects of pre- and post-approval tracking of biotechnology-derived animals,
• raised questions of enforcement of tracking and potential for industry self regulation,
• emphasized importance of tracking for international trade, and
• underlined the urgent need for dissemination of information to the farming community and general public, as well as a need to involve consumer and special interest groups in similar future consultations.

In the discussion, government regulatory staff provided explanations, clarifications and opinions relevant to the points raised.

In his concluding remarks, Dr. Evans, Executive Director of the CFIA Animal Product Directorate and Canada’s Chief veterinary Officer, expressed CFIA’s appreciation of the investment of time into the Consultation by the participants and of recent progress made in animal biotechnology regulation; spotlighted future needs for close collaboration and synergy among all involved in animal biotechnology and its regulation; and emphasized the importance of gaining credibility through open communication with the general public, in which animal tracking will play an important role.