This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.
Canadian Regulatory Aspects of Gene Editing Technologies - Christine Tibelius
1. ยฉ 2017 Her Majesty the Queen in Right of Canada
(Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.
Canadian Regulatory Aspects of
Gene Editing Technologies
Christine Tibelius, Director
OECD Conference on Genome Editing
June 29th, 2018
2. โข Area of great interest in Canada โ trade & regulation
โ government
โ stakeholders: industry, academia, research institutes
โข Hosted workshop on โGene editing in an international
context: scientific, economic and social issues across
sectorsโ, September 2016 in conjunction with OECD
โ OECD Science, Technology and Industry Working Paper
2018/04
โข Participated in industry led workshop on new plant
breeding techniques including gene editing, in May
2017
Gene Editing
3. Biotech-Related Oversight in Canada
Lead Product Regulation
Canadian Food
Inspection
Agency
Livestock feed Feeds Act
Seeds Seeds Act
Fertilizer Fertilizers Act
Veterinary biologics Health of Animals Act
Health Canada
Pesticides Pest Control Products Act
Novel foods, drugs, and
biologics, medical devices
Food and Drugs Act
ECCC, HC, DFO
Animals and all other
substances
Canadian Environmental
Protection Act
AAFC, GAC, ISED
Non-regulatory
considerations
Market access, industrial policy,
socio-economic impacts, trade
ECCC โ Environment & Climate Change Canada; DFO - Fisheries & Oceans Canada; AAFC โ Agriculture &Agri-Food
Canada; GAC โ Global Affairs Canada; ISED โ Innovation, Science &Economic Development Canada
4. Same trait, regardless
of technology (process)
Canada regulates
PRODUCTS Breeding
X
Random
Mutagen
X
Targeted
Mutagen
X
Transgenic
(GMO)
X
Since there are many paths to the same result,
the consistent and risk-based regulatory
approach is to regulate products, not processes.
Canadian Regulatory Approach
Genetic
Deletion
X
5. Canadian Regulatory Approach
โข Canada requires a pre-market safety assessment for
agriculture biotechnology products, including products
produced through gene editing, only if they are novel
(i.e., express a new characteristic) and could therefore
pose a new risk.
โข Canada does not require a pre-market safety
assessment for products gene-editing, that do not
express a novel trait.
6. Risk-Based Regulatory Approach
Risk-Appropriate Regulation
โข Pre-market assessment required for โnovelโ products
โข Not every product would be considered โnovelโ in terms of
environmental release (e.g., Orange petunia)
Flexibility of Information Requirements
โข Not prescriptive
โข Case by case
โข Outcome based
7. Regulation of a Novel Plant Product
Product
i.e. Canola with
Herbicide Tolerance CFIA โ Novel
Feed
HC โ Novel Food
CFIA โ Plants with
Novel Traits
8. Authorization Process
Novel Food
Assessment
(Health Canada -
Food & Drugs Act)
Livestock Feed
Assessment
(CFIA โ Feeds Act)
Environmental
Assessment
(CFIA โ Seeds Act)
Authorization For
Livestock Feed Use
No Objection
For Human Food Use
No-split
approval
policy
Other non-PNT/GMO
regulatory requirements (e.g.
Variety Registration)
Commercialization
Authorization
For Unconfined
Environmental Release
9. Regulatory Pathway
โข Cultivation of plants and use as food and feed are
regulated under different pieces of legislation that have
different purposes
โข The regulatory triggers for novel foods, novel feeds and plants
with novel traits (PNTs) are somewhat different
โข Different regulatory triggers specific to novel foods, novel
feeds and PNTs is important
โข This ensures that developers are only subject to the regulatory
oversight that is required and appropriate for their particular
product
10. Unconfined Environmental Release
Plants with a novel traits (PNTs) are defined as:
โข Plants into which one or more traits have been intentionally
introduced, and
โข Where the introduced trait is both new to cultivated populations of
the species in Canada and has a potential to affect the specific use
and safety of the plant with respect to the environment and human
health
โข Risk assessments consider 5 pillars:
โข Potential for weediness
โข Consequences of gene flow
โข Becoming a plant pest
โข Impact on non-target organisms
โข Biodiversity
11. Unconfined Environmental Release
โข The assessment is comparative
โข Does the addition of novel trait(s) change the plantโs impact on the
environment in comparison to the same crop being grown in an
agricultural setting?
โข Authorized products have been assessed and found to
be as safe as comparable products with a history of safe
use
โข Allows the release of a PNT into the environment with
limited or no restrictions
โข May require stewardship plans
12. Sustainability โ Stewardship
Requirements
โข Stewardship plans include strategies allowing for
environmentally safe and sustainable use of PNTs
โข Plans consider recent available scientific evidence,
communication with growers, efficient reporting of
problems to the developer, and monitoring
โข Stewardship plans include:
โข Herbicide tolerant management
โข Insect resistance management
โข Disease resistance management
13. Novel Feeds
โข Any feed ingredient that is new (i.e. not listed in the Regulations), or
has been modified such that it differs from conventional parameters,
is required to undergo a pre-market assessment
โข Only feed ingredients that have been approved and evaluated by the
CFIA may be used in livestock feeds; approved ingredients are
listed in Schedules IV and V of the Feeds Regulations
โข Feeds with novel traits can be developed by such methods as
traditional breeding, mutagenesis, cell fusion, recombinant DNA
techniques, etc.
โข Products derived from Biotechnology (microbial, plant or animal
sources) are treated the same as non-biotech feeds
14. Novel Food Definition
โข A substance, including a microorganism, that does not
have a history of safe use as a food
โข A food that has been manufactured, prepared, preserved
or packaged by a process that:
โข has not been previously applied to that food, and
โข causes the food to undergo a major change
15. Novel Food Definition
โข A food that is derived from a plant, animal or
microorganism that has been genetically modified such
that:
โข the plant, animal or microorganism exhibits characteristics that
were not previously observed in that plant, animal or
microorganism
โข the plant, animal or microorganism no longer exhibits
characteristics that were previously observed in that plant,
animal or microorganism, or
โข one or more characteristics of the plant, animal or microorganism
no longer fall within the anticipated range for that plant, animal or
microorganism
17. Guidance on PNTs, Novel Feed and
Novel Food
โข Plain language Questions and Answers about gene
editing-derived PNTs โ a work in progress
โข Existing Guidance on Novelty
โข For PNTs - Dir2009-09
โข For animal feed, the guidance can be requested through
Afd_daa@inspection.gc.ca
โข Existing Guidance on data requirements
18. Animals
โข In Canada, genetically modified animals are regulated
under the Canadian Environmental Protection Act for
potential environmental or indirect human health
concerns.
โข No specific policy on gene editing yet but inquiries are
coming in.
โข Will need to carefully examine the resulting organism for
all genetic changes โ case-by-case RA.
19. Stakeholder Engagement
โข Proponents are encouraged to contact regulatory
authorities early in the product development process to
discuss:
โข Potential regulatory requirements (Pre-submission consultations)
โข Novelty determinations
โข Regulators regularly engage with stakeholders:
โข Biotechnology working groups
โข Technical meetings with industry and academia
20. Regulatory Challenges
โข Some plant or animal products modified through use of gene
editing may be considered novel in Canada and not regulated
in other jurisdictions
โข Regulatory asymmetry, asynchronous approvals may
increase complexity
โข Canada is committed to ensuring that new technologies do no
face obstacles to innovation while ensuring sufficient
oversight to protect public interest, and is consulting with
value chain stakeholders to ensure that our regulatory system
continues to perform well as new technologies emerge
21. Socio-economic Factors
โข Are not considered within our risk assessment
frameworks
โข Upon approval, a novel product is considered to be equivalent to
its conventional counterparts
โข Producers are free to choose amongst products deemed to be
safe and to implement the production methods and marketing
strategies of their choice
22. Take Home Messages
โข Since there are many biotechnological techniques that can be used to
achieve the same result, the consistent risk-based regulatory approach
is to treat comparable products alike.
โข Canada regulates PRODUCTS, which may include some products of
plant or animal breeding innovations (e.g. CRISPR).
โข Canadaโs regulations have the flexibility to include evolving
technologies, when a product is novel.
โข Ultimately, this is a system that allows for consistent decision-making
and a clear regulatory path, which are both essential to supporting
innovation.
23. For more information concerning
novel products
Health Canada Web address:
https://www.canada.ca/en/health-canada.html
Feed Web address :
http://www.inspection.gc.ca/animals/feeds/eng/1299157225486/132053
6661238
Environmental Release (PNT) Web address:
http://www.inspection.gc.ca/plants/plants-with-novel-
traits/eng/1300137887237/1300137939635