Canadian regulatory aspects of gene editing technologies

Area of Science:

• Agricultural biotechnology
• Genetics and breeding
• Regulatory science

Background:

• Gene editing is revolutionizing plant and animal breeding with new trait development.
• Canada views gene editing as another tool within existing breeding methods.
• Current regulations focus on product novelty, not the breeding process.

Purpose of the Study:

• To outline Canada's regulatory approach to gene editing in plants and animals.
• To explain how Canada's regulatory system accommodates gene editing innovations.
• To highlight the science-based, risk-appropriate decision-making process.

Main Methods:

• Focus on potential risks of novel traits or products entering the Canadian environment or market.
• Canadian Food Inspection Agency regulates environmental release of plants and livestock feeds.
• Health Canada regulates novel foods, co-regulating modified animals with Environment and Climate Change Canada.

Main Results:

• Canada's regulatory system efficiently adjusts to new breeding technologies like gene editing.
• The novelty-driven approach allows for risk-appropriate regulatory decisions.
• Existing regulations encourage innovation while maintaining science-based oversight.

Conclusions:

• Canada's regulatory framework is well-equipped to handle gene editing innovations.
• Cooperative efforts between regulators and proponents ensure products meet novel product definitions.
• The system supports innovation in plant and animal breeding while ensuring safety.