United States-Canada Regulatory Cooperation Council TBWG Fall Plenary November,

Regulatory Cooperation Council (RCC) A New Era in U.S.-Canada Regulatory Partnership On December 7, 2011, the two leaders announced the RCC Joint Action Plan: 29 initiatives A focused and practical approach with significant advancements in 4 key sectors: agriculture & food, health & consumer products, transport, the environment, and two cross-sectoral initiatives (Nanotech, Small Business Lens) Opportunity to move beyond previous approaches to cooperation, advance regulatory relationship to a new level 2

Building from the RCC Joint Action Plan Each initiative represents a vehicle to create a new form of advanced cooperation that will expand into other areas Resolve existing issues while setting precedent for future solutions – lasting regulatory cooperation mechanisms to ensure ongoing alignment Partnering and collaborating between our countries to improve efficiency and effectiveness while preserving the protection of health, safety and the environment, and respecting each others’ sovereignty 3

Why with Canada and the United States? U.S.-Canada relationship is unique The U.S. and Canadian manufacturing sectors and supply chains are highly integrated – we are each other’s greatest export market – and any improvements would yield immediate overall benefits We both have robust, successful regulatory regimes achieving the same general outcomes Our regulators have pre-existing cooperative relationships These provide the United States and Canada with a unique set of prerequisites for high impact and success 4

U.S.-Canada RCC Joint Action Plan: The first step towards fundamental change Joint Action Plan initiatives represent areas of regulatory business that can be better aligned Key mechanisms for regulatory cooperation: Reliance on each others’ regulatory systems Reduce and eliminate duplicative requirements by recognizing success of each others’ work Regulatory Standard Setting Partner on regulatory standards development, conformance (e.g. testing), and implementation/ enforcement tools (cont.) 5

Key Areas of Regulatory Cooperation (cont.) Product Approval Collaborate on aligning submissions, analyses, and approval processes Compliance and Enforcement Support each others’ efforts in ensuring regulatory compliance and enforcement Anticipatory Outlook Aim to prevent divergent regulations in the future by coordinating current regulatory approaches 6

Stakeholder Involvement & Priority: RCC Commitment Stakeholder involvement is critical to: Share ideas on work plan details and practical implementation realities Provide ongoing feedback to support successful outcomes Play a role in ensuring work plans reflect industry reality and expectations 7

Stakeholder Involvement (cont.) Next RCC stakeholder meeting scheduled to occur in Canada in early 2013 Feedback is welcomed throughout the RCC process(See ) Working Groups develop their own ongoing processes with stakeholders on individual workplans/groups Get in contact with groups you’re interested in and let them know you want to be involved 8

January 31, 2012 Sessions with Working Groups Over 240 American and Canadian stakeholders participated Full day of stakeholder engagement, divided into individual technical review and advisory sessions These sessions sought stakeholder input on: 1.The resolution of issues in the Joint Action Plan 2.Regulatory cooperation mechanisms to secure ongoing alignment into the future 9

Key Questions for Consideration What do you see as the best ways to achieve regulatory cooperation between the United States and Canada? How can we best maintain a focus on regulatory cooperation between the United States and Canada? How can we ensure stakeholders remain informed and engaged in the RCC process? What do you see as key barriers to regulatory cooperation and how should these be addressed? 10