U.S. Department of State

Points of Contact

European Commission: Takis Daskaleros Head of Sector-DG SANCO Email: Panagiotis.Daskaleros@ec.europa.eu Telephone: 02-295-6774	U.S. Government: Nancy Beck, Office of Information and Regulatory Analysis, OMB Email: nancy_beck@omb.eop.gov Telephone: (202) 395-3258
EU Delegation in Washington: (name) Email: Telephone:	U.S. Mission to the EU: Telephone: 02- 508-2756

Reference

Framework Section II and Annex I, A.

Goal

To eliminate unnecessary regulatory divergences by fostering greater understanding of and convergence in our respective overall approaches to regulation in such areas as risk analysis, metrology, cost benefit analysis, impact assessments.

Specific Objectives

1. External Impacts: Review application of regulatory impact analysis guidelines so impacts on trade and investment are considered, as appropriate.

2. Develop methodological framework to ensure comparability of impact assessments, especially risk assessment and cost-benefit analysis.

Progress

1. External Impacts: Completed. OMB’s Office of information and Regulatory Analysis (OIRA) and EC Impact Assessment Board (IAB) issued joint report in May 2008 on how each side addresses trade and investment impacts in our respective regulations; both sides followed up with revised guidelines to ensure such impacts are considered; in the U.S., regulations that have international impacts are specially flagged.

2. Risk analysis: OMB and the U.S. Office of Science and Technology Policy (OSTP) began conversations with DG SANCO to facilitate an international dialogue on risk analysis, leading to OMB-OSTP hosted risk analysis discussions in July, 2008 with representatives from the U.S., EU, and Canada participating. With OMB and OSTP support, DG SANCO built on the summer dialogue by hosting the 1^st International Conference on Risk Assessment in Brussels in November, 2008. In January 2009, OMB, SANCO, and Canada government risk managers reinstituted the practice of weekly conference calls to keep moving forward in putting together international work groups that will develop products (likely white papers) in 3 focus areas:

• development of a framework for exposure assessment,
• development of a framework for emerging risks,
• development of frameworks for improving terminologies and methodologies used to characterize uncertainty.

3. Import Safety: Completed. OIRA and IAB submitted a joint report "Towards enhanced cooperation between the European Union and the United States of America on the safety of (imported) products" to the May 2008 TEC.

Next Steps

1. External Impacts: At the July 24, 2009 meeting of the High Level Regulatory Cooperation Forum (HLRCF), OMB/OIRA and EU SecGen Director for Impact Assessment agreed it would be useful to look at the impact of regulation on SMEs. SecGen office also expressed interest in exploring further an integrated U.S.-EU approach to impact assessment that incorporates economic, environmental, and social impacts, as well as the area of impact assessments and health.

2. Risk Analysis: The three risk assessment papers are expected the first half of 2010.

Also, at the July 24, 2009 meeting of the HLRCF, OMB and SANCO elaborated on the said the development of the emerging risk framework and said it would include:

• a joint analysis of past crises to gather lessons learned from how emerging risks associated with those crises were assessed.
• an evaluation of how to best utilize new state of the art “avant garde” technologies, such as toxicogenomics and systems biology to inform adverse effects in risk assessments.