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Susan E. Dudley, Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office of the President


April 24, 2008

It is my pleasure to be here in Brussels this evening to discuss our ongoing activities to promote global trade and investment through increased international regulatory cooperation. Transatlantic regulatory cooperation is crucial, of course, given that the U.S. and EU have the largest bilateral trade and investment relationship in the world. The opportunities are exciting because we have leadership in both the EU and the US that are very interested in improving regulatory cooperation and reducing regulatory barriers to trade.

And, of course, we also have the Transatlantic Policy Networks’ (TPN) visionary support, starting over 15 years ago, for promoting closer economic and political ties between the US and Europe. We particularly appreciate its official support at recent US-EU Summits for the concept of eliminating the remaining barriers to trade and investment across the Atlantic and for the action plan on how to move forward.

My office – the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget – oversees regulatory and information activities of the United States. As these regulatory issues have greater and greater effects internationally, we find ourselves increasingly involved both with U.S. regulators and our international counterparts to ensure we minimize unnecessary regulatory differences, which can impose barriers to trade.

We are pleased to co-chair the High Level Regulatory Cooperation Forum with DG Enterprise, and to work with the General Secretariat on efforts to improve the way our respective regulatory impact analyses reflect international trade and investment effects. Tomorrow we will hold our second meeting of the Forum, which brings together top officials from the U.S. and EU. Our first meeting took place in the US, in conjunction with the Transatlantic Economic Council (TEC) meetings in November 2007, and it was successful on several dimensions.

First, while many of our senior policy officials know and work with their direct counterparts in their own regulatory areas, this proved a useful forum for getting acquainted with regulators in different areas. We were able to exchange ideas on cross-cutting issues – discussing what works, what doesn’t – and we agreed on next steps not only to continue the dialogue but to coordinate on regulatory activities.

Second, we had substantive discussions that focused on two cross-cutting issues – import safety, and risk assessment, particularly of emerging issues.

With respect to import safety, the Forum participants agreed that information sharing is essential. For example, there was mutual interest in developing a common database on product recalls so that we can learn from each other. We do face legal and administrative constraints on sharing confidential data, and we discussed how we could address them.

We all recognized that responsibility for import safety is shared among exporting country, importing country, and the private sectors in each country. Incentives do matter, and such things as brand and reputation play an important role.

We also discussed the importance of mutual recognition, and there was a consensus that inspections alone are insufficient. It was understood that we need to focus on highest risk points, and understand that efforts should be tailored to the product, risks, and benefits. Such a risk-based approach will require collaboration before regulation so that both governments understand the risks.

In preparation for tomorrow’s meeting, we have surveyed regulatory agencies on both sides of the Atlantic to gain a better understanding of authorities and practices, and also barriers to sharing information. We plan to discuss the results of these surveys tomorrow, and develop a report to deliver to the TEC next month.

At the November 2007 Forum, we agreed on the need to develop a sound, risk-based regulatory pathway that encourages innovation, especially in emerging technologies. We discussed the value of a two-step process: (1) risk assessment to understand risks and (2) risk management policies to respond to risks. This will involve the sharing of data, analysis, and risk assessment studies.  While actual regulatory outcomes may be different due to different legal and policy frameworks in the U.S. and EU, both sides are nonetheless interested in collaborating on studies and mutual acceptance of research results, to gain a shared understanding of risks.

To develop these ideas further, we are discussing plans for a joint workshop on risk assessment, which we will highlight at tomorrow’s Forum. We will host a transatlantic risk dialog for scientists and policy officials from the US, Canada and the EU in July 2008, and DG SANCO is planning to host a major conference on risk assessment here in Brussels in the fall of 2008.

Last fall, OMB and the Secretariat General of the European Commission (EC) presented a joint draft report on taking into consideration the international trade and investment effects of regulation in regulatory analyses. After seeking public input on this report, we have drafted a final report that takes those comments into account, which we will share tomorrow with members of the Regulatory Forum. We plan to have a final report to deliver next month to the TEC.

I look forward to the Forum meeting tomorrow, and the TEC meeting in May. I think coordination and alignment of our regulatory systems presents our best opportunity for more open markets that improve opportunities for citizens on both sides of the Atlantic. The focus of the Forum’s discussions is particularly important for that goal. If we can facilitate better information sharing, and come to agreement on what constitutes sound impact and risk analysis, we can minimize unnecessary future regulatory divergences.

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