1. United States-Canada Regulatory Cooperation Council United States-Canada Regulatory Cooperation Council January 30, 2012 Washington D.C. 1.1048952

2. 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 Opportunity to move beyond previous approaches to cooperation, advance regulatory relationship to a new level Regulatory Cooperation Council (RCC) A New Era in U.S.-Canada Regulatory Partnership 2.

3. 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 3.

4. Why with Canada and the U.S.? 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.

5. 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.

6. Key areas of regulatory cooperation (cont.) Product Approval Collaborate on aligning submissions, analysis, and approval processes Perimeter Challenges Joint focus of efforts on challenges and threats from offshore and avoid requirements at the U.S.-Canada border Compliance and Enforcement Supporting each other efforts in ensuring regulatory compliance and enforcement 6.

7. 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 Two levels of involvement: January 30: RCC – Input and broad discussion on regulatory cooperation between the United States & Canada (cross- sectoral considerations) and the aggregate work plan January 31: Working Groups – Sector-specific technical discussions and input on the work plans for the RCC Joint Action Plan initiatives 7.

8. Stakeholder Involvement (cont.) Next RCC stakeholder meeting scheduled to occur in Canada later in 2012 Feedback is welcomed throughout the RCC mandate Working Groups will develop their own ongoing process with stakeholders on individual workplans / groups 8.

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

10. 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? Key Questions for Consideration 10.