Ian Affleck, Vice President Biotechnology CropLife Canada Carla St. Croix, Director

1. Supporting Innovation in Plant BreedingJoint Industry-Government effort to evolve Canada’s approach to plant biotechnology to meet emerging challenges Ian Affleck, Vice President Biotechnology CropLife Canada Carla St. Croix, Director Innovation and Growth Policy Agriculture and Agri-Food Canada Grains Value Chain Roundtable Biotech Working Group Summer/Fall 2018

2. Context • Industry (through the Grains and Seed Sector Value Chain Roundtables) wrote to the Minister of Agriculture (April 2018) requesting improved guidance, predictability, clarity and transparency for Canadian innovators in the pre-market assessment of products developed through plant breeding innovations (desired outcomes, as expressed in the annex to the letter to the Minister - see Annex I). • In his response, the Minister acknowledged that Canada’s science-based regulatory system is integral to supporting domestic and international confidence in Canadian agriculture and agri-food products, including those produced through plant breeding innovation, and that there is benefit in ensuring the system continues to encourage innovation and facilitate trade, thereby supporting the Canadian agricultural growth agenda (correspondence available at Annex II). The Minister committed to a continued industry-government dialogue to identify priority challenges and to seek opportunities for continuous improvement (Annex II).

3. Problem identification • Consensus among government and industry is that the novelty approach is sound, but opportunities exist for enhancing predictability and efficiency in the delivery of Canada’s novel plant, food and feed regulatory programs • Industry stakeholders are asking for action, such as: • a well-defined process for novelty determination, including expectations on what information will be required to be submitted and when a response / determination can be expected (e.g., process similar to “Am I Regulated” available in the U.S.) • increased efficiencies in the Canadian regulatory system for plant breeding innovations, where possible, to continue to stimulate innovation and enable a broader range/volume of products that can be accessed by producers and export markets • Government officials remain aware that any changes to the method of delivery of the regulatory framework for products of plant biotechnology could affect other products regulated under the same framework (e.g., microorganisms and animals).

4. Proposed way forward • The Biotech Working Group (BWG) under the Grains Roundtable (GRT), can be used as an additional forum to continue industry-government dialogue to identify priority challenges to plant breeding innovation and options/solutions that work for both industry and government. • The BWG includes representatives from industry, regulators (as observers) and AAFC. • A smaller “Technical Group” struck under the BWG (The BWG Technical Group) can carry out detailed analysis needed to further refine issue identification and propose options/solutions to be endorsed by the BWG, GRT and All Chairs Roundtable respectively. Director-level meetings have and will continue to guide the work of the Technical Group. • The purpose / objectives of the BWG Technical Group will be to: • Facilitate a continued open dialogue on challenges being posed to the delivery of the Canadian regulatory system by the emergence of plant breeding innovations, including consideration of the evolving global regulatory landscape. • In line with the stated operating principles (next slide), develop advice and recommendations that, for both industry and government, may improve the efficient and effective delivery of regulatory programs, and enhance safety and economic objectives that fall within the mandate of CFIA, HC and AAFC. • Present the recommendations and advice to the BWG for consideration.

5. Proposed BWG Technical Group operating principles • Safety is always the first priority • Programs must remain science and risk-based • A product-based (i.e., outcomes-based/novelty-based) approach remains the foundation of regulatory programs • Programs must be functional for both innovators and regulators: • A flexible outcomes-based approach to regulation is preferred, with sufficient guidance and opportunity for case-by-case discussion with regulators • Programs must be effective and efficient at delivering the regulatory mandate, including by providing the necessary clarity and predictability to support product development decisions (i.e., programs approach considers client perspective) to the extent possible without adopting a prescriptive approach • Transparency, education, and a sound regulatory program are building blocks in an advocacy strategy for improved investment, public acceptance, and market access for innovative products of biotechnology • As options are developed by the BWG Technical Group, consideration will be given to impacts to other products regulated under the same framework (e.g. microorganisms and/or animals); as well as opportunities for effective public communication efforts • Maintaining market access and confidence in the Canadian system for producers/ exporters

6. BWG Technical Group roles and responsibilities Industry members • Articulate specific, actionable, value-chain priorities and needs • Fully develop proposals and analysis of possible options from an industry perspective • Support transparency by encouraging members to proactively provide public information about products submitted to the regulator for assessment • Contribute to potential advocacy strategies relating to market access and education Regulators • Strive for continuous improvement of the regulatory programs • Provide advice on what is achievable within the existing regulatory frameworks and in balance with other program priorities and resources, so that the group is well-positioned to recommend options that are feasible to implement • Provide guidance and ultimately vet best approach and actions under the BWG to be considered by government initiatives as appropriate (e.g., the Increasing the Transparency and Efficiency of the Regulation and Assessment of Novel Products (ITERANP) work plan), to help modernize regulatory program delivery and implementation AAFC • Facilitate the BWG and BWG Technical Group discussions and identify opportunities to move the work forward • Provide sectoral and policy expertise on domestic issues related to biotechnology, as well as the opportunities and risks associated with the international regulatory environment • Inform work of the BWG Technical Group so that it can contribute to Canada’s international engagement efforts to prevent market access issues for products of PBI

7. Governance schematic

8. Process description • Regular meetings (monthly or as needed) of the BWG Technical Group during fall 2018 to clearly scope the issues and develop and prioritize options • Co-Chairs of the BWG, or their designates, will organize and chair meetings • Government or industry representatives can bring ideas and proposals forward for discussion and analysis • The GoC BWG Co-Chair, or their designate, will maintain a record of decisions and/or activities undertaken • BWG will provide broad direction on options to be fully developed by the BWG Technical Group - target of fall 2018 • BWG will present potential options/solutions refined by the BWG Technical Group to the Grains Roundtable, in consultation with other VCRTs as needed - target December 2018 • Grains Roundtable to provide advice and bring forward recommended options to government - early-mid 2019 • Government to further consult as necessary and implement chosen solution(s) – by end of 2019 • Any options and/or recommendations brought forward by the Grains Roundtable to government will not be binding and will be considered by / inform existing work plans, as appropriate (e.g., the ITERANP group work plan).

9. Related GoC activities Work of the BWG / BWG Technical Group should be informed and influenced by ongoing broader GoC discussions, such as: • Seed Synergy • A broad-based collaborative effort between seed industry partners to work with relevant GoC departments to stimulate investment and growth across the seed value chain through enhanced transparency and efficiency • Regulatory Review • ABudget 2018 announcement of a regulatory renewal process across government beginning with selected sectors including agri-food and aquaculture • Economic Strategy Tables • Includes one focussed on Agri-Food (with regulatory agility and industry competitiveness considerations) • Recommendations provided in Economic Strategy Table Report on Agri-Food (fall 2018) aim to exceed 2017 Barton Report ag. sector growth target of $75 billion to achieve $85 billion in exports by 2025

10. ANNEX I: Industry desired outcomes As expressed in the Annex to the letter to the Minister of Agriculture (April 2018)

11. ANNEX II: Minister’s reply to industry (June 2018)

12. ANNEX III: Canadian regulatory frameworks • Canada is at the forefront regarding biotechnology authorizations, with over 120 plant products of biotechnology authorized. While asynchronous authorizations have always been a global challenge, GoC and industry have worked to effectively manage trade impacts to date • Assessment of novel plant products falls within the mandates of both the CFIA and Health Canada  • Each program has similar but distinct novelty-based triggers, and distinct assessment endpoints • These outcome-focused regulatory programs provide flexibility in: • which products may be considered to be novel • which aspects of novel products require an assessment • what information is used to meet assessment endpoints • This flexibility allows for adaptability to emerging technologies, but creates challenges in providing definitive guidance on how and whether various innovative products will require an assessment • Continuous improvement to programs and guidance, informed by stakeholders, is needed as technologies and knowledge evolve. This ongoing dialogue between industry and the regulator has a track record of successful program adaptations.

13. ANNEX: BWG Membership lists Ad-Hoc Directors’ Group Co-Chairs: Ian Affleck (CropLife Canada), Carla St. Croix (SPB/ AAFC) Membership includes: • Agriculture and Agri-Food Canada – Lauren Donihee, TTPD/MISB, Nathalie Durand, Erin Bureau, SDAD/MISB, Eric Loubier PPD/STB • Health Canada – Denise MacGillivray • Canadian Food Inspection Agency – David Bailey, Sergio Tolusso, Robert Favrin, Cecile Girard, Heather Shearer • Canadian Seed Trade Association – Dave Carey • Canada Grains Council – Krista Thomas Biotech Working Group Co-Chairs:Ian Affleck (CropLife Canada), Carla St. Croix (SPB, AAFC) Membership includes: • regulatory departments and agencies (HC and CFIA) as well as AAFC • industry: BWG Technical Group* Co-Chairs: Ian Affleck (CropLife Canada), Giuliano Tolusso (SPB/ AAFC) – or their working-level designates/colleagues Membership includes: • Agriculture and Agri-Food Canada – Jessica King (SPB), Jarett Goodwin, Erin Bureau, Emily Silk, Nicholas Gauthier (MISB), Christian Malouin, Jake Eelman (STB) • Health Canada – Neil Strand • Canadian Food Inspection Agency – Heather Shearer • Canadian Seed Trade Association – Claudio Feulner • Canada Grains Council – Krista Thomas * Membership of the Technical Group to be driven by tasks being undertaken at a given time.