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Appropriate Oversight of Plant Breeding Innovation: Solutions Ian Affleck, VP, Plant Biotechnology, CropLife Canada CSTA/CSGA, July 10 th Whistler, Canada.
Appropriate Oversight of Plant Breeding Innovation: SolutionsIan Affleck, VP, Plant Biotechnology, CropLife Canada
CSTA/CSGA, July 10th Whistler, Canada.
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Representing the Canadian developers, manufacturers and distributors of pest control products and products of modern plant breeding innovations.
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■ Changes to the plant breeding landscape are making it more challenging to predict the regulatory status of a product
■ Solution: A review of what triggers novelty and an exemption for conventional breeding
■ Solution: Updated and revised guidance which clearly indicates to innovators, and regulators, what products are “novel”
■ In order to have a flexible/responsive CDN product based system grey areas will always exist
■ Solution: Provide a “novelty opinion” process by which innovators can approach government and receive a rapid response providing additional certainty (ie. USDA “Am I Regulated” process)
Challenge:
How do I figure out if “novelty” regulations apply to my breeding activities / products
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■ Currently info requirements are significant and default to one size fits all
■ Solution: A tiered assessment framework, i.e.
■ Tier 3: Novel but no assessment required
■ Tier 2: Familiar/well understood products/traits
■ Tier 1: Truly new/unfamiliar/complex
■ Info requirements should be focused on hypothesis for risk, building on 20 years of experience
Challenge:
If I require pre-market safety assessment how do I know what information I need to provide to the regulator?
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■ In order to support market acceptance value chains will need strong communication and access to information
■ Solution:
■ Appropriate public disclosure of government decisions (i.e “novelty opinions” and regulatory authorizations)
■ Industry best practices which promote value chain consultation and cooperation
■ Information gathering and distribution that supports innovation and market access
Challenge:
To support new products entering the marketplace how do we lead in transparency and information sharing?
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Driving toward success
■ Industry/Government Technical Working Group is identifying and responding to problem areas
■ New guidance documents and “novelty opinion” processes are underway
■ Principles for a tiered structure are being developed to guide investigation and development
■ Broader policy discussions may be needed to set the stage for the changes that are required to provide clarity and predictability
