This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.

1. © 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. • Area of great interest in Canada – trade & regulation
– government
– stakeholders: industry, academia, research institutes
• Hosted workshop on “Gene editing in an international
context: scientific, economic and social issues across
sectors”, September 2016 in conjunction with OECD
– OECD Science, Technology and Industry Working Paper
2018/04
• 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 – Environment & Climate Change Canada; DFO - Fisheries & Oceans Canada; AAFC – Agriculture &Agri-Food
Canada; GAC – Global Affairs Canada; ISED – 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
• 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.
• 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
• Pre-market assessment required for “novel” products
• Not every product would be considered ‘novel’ in terms of
environmental release (e.g., Orange petunia)
Flexibility of Information Requirements
• Not prescriptive
• Case by case
• Outcome based

7. Regulation of a Novel Plant Product
Product
i.e. Canola with
Herbicide Tolerance CFIA – Novel
Feed
HC – Novel Food
CFIA – Plants with
Novel Traits

8. Authorization Process
Novel Food
Assessment
(Health Canada -
Food & Drugs Act)
Livestock Feed
Assessment
(CFIA – Feeds Act)
Environmental
Assessment
(CFIA – 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
• Cultivation of plants and use as food and feed are
regulated under different pieces of legislation that have
different purposes
• The regulatory triggers for novel foods, novel feeds and plants
with novel traits (PNTs) are somewhat different
• Different regulatory triggers specific to novel foods, novel
feeds and PNTs is important
• 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:
• Plants into which one or more traits have been intentionally
introduced, and
• 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
• Risk assessments consider 5 pillars:
• Potential for weediness
• Consequences of gene flow
• Becoming a plant pest
• Impact on non-target organisms
• Biodiversity

11. Unconfined Environmental Release
• The assessment is comparative
• Does the addition of novel trait(s) change the plant’s impact on the
environment in comparison to the same crop being grown in an
agricultural setting?
• Authorized products have been assessed and found to
be as safe as comparable products with a history of safe
use
• Allows the release of a PNT into the environment with
limited or no restrictions
• May require stewardship plans

12. Sustainability – Stewardship
Requirements
• Stewardship plans include strategies allowing for
environmentally safe and sustainable use of PNTs
• Plans consider recent available scientific evidence,
communication with growers, efficient reporting of
problems to the developer, and monitoring
• Stewardship plans include:
• Herbicide tolerant management
• Insect resistance management
• Disease resistance management

13. Novel Feeds
• 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
• 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
• Feeds with novel traits can be developed by such methods as
traditional breeding, mutagenesis, cell fusion, recombinant DNA
techniques, etc.
• Products derived from Biotechnology (microbial, plant or animal
sources) are treated the same as non-biotech feeds

14. Novel Food Definition
• A substance, including a microorganism, that does not
have a history of safe use as a food
• A food that has been manufactured, prepared, preserved
or packaged by a process that:
• has not been previously applied to that food, and
• causes the food to undergo a major change

15. Novel Food Definition
• A food that is derived from a plant, animal or
microorganism that has been genetically modified such
that:
• the plant, animal or microorganism exhibits characteristics that
were not previously observed in that plant, animal or
microorganism
• the plant, animal or microorganism no longer exhibits
characteristics that were previously observed in that plant,
animal or microorganism, or
• one or more characteristics of the plant, animal or microorganism
no longer fall within the anticipated range for that plant, animal or
microorganism

16. Breakdown of Authorized Crop Kinds
Corn
31%
Soybean
17%
Brassica napus
12%
Cotton
12%
Wheat
7%
Potato
6%
Rice
4%
Sunflower
2%
Alfalfa
2%
Brassica
rapa
2%
Sugar beet
2%
Brassica
juncea
2%
Apple
1%
Flax
1%
Lentil
1%
Sorghum
1%
Note:
“Novel crop kinds”
include both GM
and non-GM novel
crops (mutagenesis,
etc.)

17. Guidance on PNTs, Novel Feed and
Novel Food
• Plain language Questions and Answers about gene
editing-derived PNTs – a work in progress
• Existing Guidance on Novelty
• For PNTs - Dir2009-09
• For animal feed, the guidance can be requested through
Afd_daa@inspection.gc.ca
• Existing Guidance on data requirements

18. Animals
• In Canada, genetically modified animals are regulated
under the Canadian Environmental Protection Act for
potential environmental or indirect human health
concerns.
• No specific policy on gene editing yet but inquiries are
coming in.
• Will need to carefully examine the resulting organism for
all genetic changes – case-by-case RA.

19. Stakeholder Engagement
• Proponents are encouraged to contact regulatory
authorities early in the product development process to
discuss:
• Potential regulatory requirements (Pre-submission consultations)
• Novelty determinations
• Regulators regularly engage with stakeholders:
• Biotechnology working groups
• Technical meetings with industry and academia

20. Regulatory Challenges
• Some plant or animal products modified through use of gene
editing may be considered novel in Canada and not regulated
in other jurisdictions
• Regulatory asymmetry, asynchronous approvals may
increase complexity
• 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
• Are not considered within our risk assessment
frameworks
• Upon approval, a novel product is considered to be equivalent to
its conventional counterparts
• 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
• 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.
• Canada regulates PRODUCTS, which may include some products of
plant or animal breeding innovations (e.g. CRISPR).
• Canada’s regulations have the flexibility to include evolving
technologies, when a product is novel.
• 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