CropLife Canada and the Canadian Seed Trade Association February, 2017 Responsibly Introducing a Marketplace for Seeds Containing Generic Novel Traits CropLife Canada and the Canadian Seed Trade Association February, 2017

Background Canadian regulatory approval of plants with novel traits (and novel foods and feeds) carries with it a responsibility of stewardship of the events by the original developer. Intellectual property rights tied to traits provides a “simplified” tool that can enable stewardship and control market access. As the property rights expire there is a potential market for seed containing generic novel traits (SGNT). Such SGNT seeds expose gaps in government and industry oversight of stewardship and represents a potential product use and export trade issue. Product use may include chemistry use and associated MRL’s Novel Traits in Canada are any characteristic that may be deemed “novel” and was not present in commercial crops prior to 1998 in Canada.

Working Group Membership CSTA: Darrel Armstrong – Monsanto Canada (co-chair) Lorne Hadley  - Canadian Plant Technology Agency Ron Weik – FP Genetics Conor Dobson – Bayer CropSciences CropLife Canada: Jennifer Hubert – Syngenta Canada (co-chair) Carol Saunders – Dow AgroSciences Todd Hyra - SeCan Kent Jennings – BASF Canada

Mandate CropLife Canada (CLC) and the Canadian Seed Trade Association (CSTA) represent over 90% of the private sector seed/trait developer entities. CLC and CSTA Joint Working Group developed a model for responsible management of SGNT, with the following requirements: Maintain export market access for Canadian seed derived products; Maintain confidence in the Canadian regulatory system and; Support sustainable production practices for generic traits and future related traits. In addition, the developed framework should ensure the industry is unified in the approach.

White Paper Completed The joint working group has completed a White Paper that provides context for value chain discussions which addresses: Current state with roles and responsibilities Challenges and risks posed under the current state Guiding principles which should be considered when developing a future state to manage risks, ensure sustainability and maintain market access

Draft Framework White Paper was distributed to value chain and government (regulatory and policy) for consideration Following from the White Paper - CLC and CSTA have jointly developed a draft proposal Draft framework includes a set of strategic objectives and potential options as a basis for further discussion

Strategic Objectives Maintain trait sustainability/durability and market access. Enable responsible generic product development and distribution. Clarify that conditions attached to current authorizations apply to seeds containing the same generic novel trait. Clarify roles and responsibilities of developers, regulators, marketers, and generic breeders. Enable new users to meet regulatory requirement and apply market access best practices to prevent trade disruption.

Framework Options Preferred Options Market access Stewardship Enforcement Stewardship Market access

Stewardship Role of Government agencies Develop a system for oversight to include: Clarification of authorization conditions for generic novel traits Mechanism to add generic users to authorization requirements (for purposes of stewardship) Update Seeds Act and/or Regulations to ensure integrity of generic novel traits in future products Government role in promoting LLP, non-expiring approvals

Stewardship Role of industry Enhance communication to growers and value chain on appropriate use through: Labelling requirements on SGNT products to include conditions of use Broad industry communication strategy explaining general requirements and responsibilities for the use of SGNT products in the marketplace Labelling covers current MTSA and TUG or similar for other parties.

International market access Government of Canada outreach to address regulatory barriers Seed industry to develop information sharing platform on IP expiry and overseas regulatory renewals Value chain stakeholders to strengthen requirement for transparent trait identification e.g Canola Council Keep-It-Clean

enforcement Revised Seeds Regulations to cover sales of SGNTs Functioning and well resourced government/industry enforcement model to ensure new requirements are met e.g. Grain Declarations, crop insurance Should we consider changes to the grains act as well Add crop insurance Grain declarations

Roles and responsibilities All of the following groups of actors in the agriculture market chain will have a role in implementing the mechanism resulting in new responsibilities. Original Developers Generic Trait Seed Developers Industry Value Chain Government of Canada Farmers

Path Forward Consult with a broad range of stakeholders and government regulators on the potential options – Jan-July 2017 Strike an industry/government working group (led by CLC/CSTA and CFIA) to progress on implementation – July/Aug 2017 Develop specific options for updating of seed regulations - late 2017 to early 2018

Value Share/define responsibilities/obligations Share/define costs/distribute to future users Clarity on enabling innovation/choice Potential model for other regions beyond Canada e.g. Australia

Ask: The Members and the organizations (CLC/CSTA) are committed to engaging in a dialogue with the broader value chain utilizing the Post Patent framework options paper to help guide the development of specific solutions to address challenges identified. The commitment to engaging in dialogue does not imply any individual member or organization supports options outlined or solutions that maybe developed based on these options.

Questions