CSTA Biotech Committee Krista Thomas, Director of Plant Innovation - - PowerPoint PPT Presentation

Plant Breeding Innovation Update CSTA Biotech Committee

Krista Thomas, Director of Plant Innovation Canada Grains Council November 28, 2017

Canada Grains Council (CGC) Member Organizations

What is Plant Breeding Innovation (PBI)?

International Seed Federation: “PBI is the term we use to describe the constantly evolving ideas and practices which enhance the field

• f plant breeding.”
• Genome Editing
• CRISPR
• Zinc Finger
• TALENS
• Cisgenesis
• Intragenesis
• Grafting on GM Rootstock
• Reverse Breeding
• Agroinfiltration

Uncertainty about how the products produced using these techniques will be regulated, how readily the public will accept them, and what the impacts will be on international trade.

What are the Benefits

What are the Benefits of PBI?

• Lifting farmer and ag sector income
• through yield increases and agronomic traits, especially in smaller-acreage crops

with limited capacity to invest in plant breeding

• Meeting consumer demand for healthier, high-quality food
• by reducing naturally-occurring mycotoxins, increasing vitamins and nutrients, or

developing new types of nutraceuticals and functional foods

• Adapting to climate change and reducing the environmental impact of

farming

• crops that need fewer inputs and help to conserve water and soil and maintain

their quality

• Fighting quarantine pests
• reducing devastating crop loss and risks to food security, as well as preventing

serious trade disruptions

What are the Real Benefits of PBI?

• Faster
• Easier
• Less expensive
• Investments in breeding programs can go further
• Opportunities for cutting-edge innovation in crops that have not

adopted GM traits

• Opportunities for small or orphan crops

If we don’t overregulate and if we have global regulatory alignment

Canadian Grain Heavily Dependent on Trade

• Majority of major field crop

production exported

• Up to 90% of some crops end up

in export markets

• For some crops there is

significant diversity in export destinations (70+ countries for wheat)

• China, EU, and Japan figure

prominently

Source: The United Nations Conference on Trade and Development International Trade Data Center. Updated 10/25/2016 VLM. $678,924

Europe Oceania Africa

$11,585

Asia

Annual Average Continent-to-Continent Trade of Grains and Oilseeds 2011-2015 (1000USD)

Americas

PBI Regulations: Global Overview

• Many countries are considering how PBI should be regulated
• Definitions of Biosafety legislation (e.g., for regulating GMOs/LMOs)
• So far, no countries have indicated they will fully exempt all products of

genome editing from regulatory oversight

• Early approaches are case-by-case and product-based
• Acknowledge the range of different products that can be produced:
• Have minimal genetic changes and could otherwise be developed using

conventional breeding techniques (SDN1)

• Have more significant genetic changes (SDN2)
• Are transgenic plants (contain a gene sequence from non-sexually compatible

species) (SDN3)

Country Snapshots

Argentina, Chile and Brazil

• Case by case reviews
• Predictable notification process (20 to 60 day review)
• Manageable data requirements
• Six decisions made so far (all conventional breeding)

Country Snapshots

Australia

• Completed a public consultation on genome editing
• Will include all but simple point mutations under GMO

regulations (SDN2 and SDN3 to be included)

• Review of Gene Technology Act underway, may allow

flexibility to treat plants differently from animals and microorganisms

Country Snapshots

European Union

• Currently a lack of regulatory clarity
• Court ruling expected December 20th may provide indication of

regulatory direction(final ruling May/June)

• Increasingly politicized, linked to GMOs and pesticides
• Increasing concerns about loss of agricultural innovation
• EU Commission SAM report provides scientific basis to treat some

PBI products like conventional:

• http://ec.europa.eu/research/sam/pdf/topics/explanatory_no

te_new_techniques_agricultural_biotechnology.pdf

Country Snapshots

China, Japan, South Korea

• Heavy investment in genome editing technology
• No published guidance or regulatory decisions at this time
• Indications that some form of upfront review will be required but

products without “foreign’ DNA should not be treated like GMOs

Country Snapshots

Canada and the US

• US agencies have consulted public
• FDA comment period closed in June
• USDA announced they will not proceed with proposed amendments
• Some products exempted under current USDA regulations
• Canadian regulators have signaled “novelty” based approach is ready to

respond to products of any new breeding method

• Industry dialogue initiated May 30th workshop to examine regulatory

framework

May 30th Workshop PRESENTED BY:

Workshop Conclusions

• Regulatory efficiency, transparency and predictability are key
• Canada needs a modernized system that addresses true risk
• Tiered model worth exploration
• Ability to adopt innovation hinges on clear, predictable and

consistent regulatory environment in all significant markets

• Build knowledge, comfort and awareness of plant breeding

innovation and the benefits it can bring to society

CGC PBI Working Group

• Formed in response to Workshop, to develop input to government

about the importance of supporting innovation in agriculture, without disrupting efficient trade

• 14 CGC members currently participating:
• CSTA, CropLife Canada, CSGA, Cereals Canada, Canola Council, Cargill,

GFO, GGC, Monsanto, Pulse Canada, Sask Flax, Soy Canada, Syngenta, Wheat Growers of Canada

PBI Policy Statement Near Final

Objective:

• The regulatory and policy environment for plant breeding

innovation (PBI) must deliver on the dual objectives of driving innovation in the crop sector while maintaining market access abroad.

PBI Policy Statement Near Final

• A whole-of-government commitment to support the introduction of PBI
• A review of Canadian regulatory policies to ensure they:
• are not overregulating, or causing a drag on domestic innovation
• are delivering the decisions and transparency required to allow entry of products into

the global marketplace

• align with like-minded trading partners on the scope of regulated products
• Proactive engagement with both like-minded and importing countries to

drive a trade-enabling and risk-based global regulatory system

• A Government of Canada public communication strategy

Other Domestic Initiatives

• Benefits paper and supporting outreach activities
• Focusing on 4 crops initially: canola, wheat, flax, lentil
• Objective to clearly demonstrate and quantify the opportunity of PBI for

these crops

• Survey of Plant Breeders
• Collect data about the impact of current Canadian regulations on R&D

International Initiatives and Forums

• ISF: ongoing international leadership role on PBI, actively

encouraging country-to-country discussion, most recently in London

• IGTC: recently finalized a position on PBI, emphasizing need for

regulatory alignment, and information sharing along the value chain, now situated to increase engagement on this issue

• OECD: considering assessment of PBI products, workshop planned

for 2018

• APEC: considering proposal for PBI dialogue among member

economies

• Extended like-minded governments forum led by USDA-FAS

Parting Thoughts

• Budget 2017 sets an ambitious goal of growing Canada’s agri-food

exports from $55 to $75 billion annually by 2025.

• The Canada Grains Council and its members believe it is Canada’s

strength in science that places this target within reach.

• Only achievable if:
• we don’t overregulate, inadvertently placing a drag on innovation
• we know Canadian grain will meet foreign regulatory requirements and flow

smoothly to international ports, this requires transparency and global regulatory coherence

• we can build consumer comfort with PBI and the benefits it can bring to

society