Patricia-McAllister

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Co-ordinated Authorizations • Authorizations are co-ordinated under HC and CFIA’s “no split” approval policy (2000) > Crops determined to be novel by the respective groups > If multiple groups determine a crop to be novel then: − Assessors work together to evaluate the product − Authorization of the product is co-ordinated > Used to minimize the potential for unapproved products to enter the Canadian environment, food or feed supplies.
Unique Process in Canada! • Focus is on the product not the process used to develop it > Regulated product can be developed by any breeding processes such as: conventional breeding, genetic engineering (GE), mutagenesis, etc. > This approach allows Canadian regulatory system to efficiently adjust to any new developments in the science of plant breeding • Biotechnology is defined differently globally > some use narrower definition focused on GE
Page 1 and 2: The Canadian Regulatory Process for
Page 3 and 4: Canada regulates novelty.
Page 5 and 6: Food & Drugs Act and Regulations A
Page 7: Novelty triggers • A PNT being as
Page 11 and 12: Why Regulate Feed? Feed versus Food
Page 13 and 14: Novelty Determination • It is the
Page 15 and 16: Regulatory Pathway for PNTs Ongoing
Page 17 and 18: Confined Research Field Trial Progr
Page 19 and 20: Scientific Information Required in
Page 21 and 22: Food and Feed Safety Assessments: 8
Page 23 and 24: Assessment Principles Other Princip
Page 25 and 26: Special Case: Stacked Events • Af
Page 27: For More Information Concerning Nov

Patricia-McAllister

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