EU-US
Regulatory Cooperation
Approaches and Experiences
Jan E. Frydman
Head of Unit for International Regulatory Agreements and Toy Safety
Directorate General for Enterprise and Industry
European Commission
Jeff Weiss
Senior Director, Technical Barriers to Trade
Office of the United States Trade Representative
WTO TBT Committee Workshop on Regulatory Cooperation Between Members
November 8-9, 2011
What do we do?
US and European regulators actively pursue cooperation through a broad range
of horizontal policy tools and sectoral activities in the area of TBTs
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Regulator to regulator dialogue – increasingly on prospective regulation
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Policy spectrum from ad hoc, informal information exchanges – to
structured dialogues – to binding government agreements (e.g., MRAs)
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Appropriate approach selected depends on policy context and objective
Why do we do it?
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In US-EU trade relationship, with relatively low tariffs, non-tariff barriers
are an increasingly important factor to address
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Reduce unnecessary cost to business/improve competitiveness, while
improving quality of regulations
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Deeper US-EU regulatory cooperation is viewed as essential activity to
promote more compatible transatlantic regulatory approaches and
enhanced economic ties
Objectives
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Minimize unnecessary regulatory divergences
Facilitate trade; minimize trade frictions
Promote better quality regulation
Reduce unnecessary regulatory burdens
Increase consumer confidence
Instruments
US and EU have pursued a variety of policy initiatives
over past decade which feature regulatory
cooperation in the area of TBTs as a key element:
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Transatlantic Economic Partnership (1998)
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US-EU MRA (1998)
Guidelines for US-EU Regulatory Cooperation and
Transparency (2002); ECJudgement 2004
US-EU Positive Economic Agenda (2002)
US-EU Economic Initiative (2005)
Framework for Enhancing Transatlantic Economic
Integration (2007)
Main Tools
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Regulatory Cooperation Roadmap
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Sectoral dialogues
OMB-EC methodological dialogue on good regulatory practices
High Level Regulatory Cooperation Forum (senior-level platform for
follow-up and cross-cutting issues)
Political oversight provided through
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Transatlantic Economic Council, TEC (2007)
US-EU Summit
Sectoral Cooperation
To advance sectoral cooperation, the US and EC have developed:
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Guidelines for Regulatory Cooperation promote procedural steps for more effective
dialogues (e.g., consultations, data sharing)
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A document on “Best Cooperative Practices”
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Confidentiality arrangements to permit sharing of non-public information between
regulators has facilitated cooperation in key areas such as pharmaceuticals, medical devices,
food safety
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Specific dialogues/activities in a number of different TBT sectors (e.g., pharmaceuticals,
medical devices, cosmetics, toys, food safety, auto safety, consumer product safety, import
safety…).
-- Increased focus on prospective regulations (or even earlier).
-- Cooperation often leverages work in pluri/multilateral fora (e.g., ICH).
-- Aim to reduce TBTs and promote compatible regulatory approaches
Sectoral Cooperation: Examples
Some illustrations of US-EU sectoral cooperation in past years:
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Pharmaceuticals – pilot projects on parallel product/substance approvals; common
format for applications; intensified cooperation on vaccines, pharmacovigilance
and counterfeit medications; agreed common format for orphan drug designations
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Auto safety - dialogue initiated to streamline adoption of global regulations,
including cooperation on specific GTRs
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Marine equipment - established a two-way alert system for unsafe equipment and
agreed to expand the product scope of MRA
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Consumer products - established a program for sharing information on recalls of
unsafe products
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Toys – successful bilateral cooperation, and third country outreach
OMB-EC Methodological Dialogue
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Dialogue established in 2005 between the US Office of Management and
Budget (OMB) - Office of Information and Regulatory Affairs (OIRA)
and relevant experts in the European Commission (led by Secretariat
General)
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Focus is to addresses methodological issues (i.e. related to good
regulatory practice), such as impact assessment, stakeholder consultation,
etc. in order to improve our understanding of each others' regulatory
systems and practices
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Results/Ongoing work includes:
-- Analysis of respective practices on impact assessments; development
of a common understanding on regulatory principles and best practices
-- Exchanges of respective regulatory workplans to help upstream
coordination/early warning
TEC
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The Transatlantic Economic Council (TEC) provides
minister-level political guidance for implementation of the
2007 Framework for Advancing Transatlantic Economic
Integration.
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First meeting in November 2007; next meeting end
November 2011
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Three main themes/areas discussed now:
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Innovation, new industries and technologies
Facilitating trade and foster regulatory cooperation
Investment cooperation
HL Regulatory Cooperation Forum
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The High-Level Regulatory Cooperation Forum was established in 2005
as a platform for senior-level regulators to agree on areas for cooperation
and promote cooperation on cross-cutting regulatory topics – such as new
technologies or policy developments that may impact multiple authorities
on each side.
Current Forum issues include:
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Standards
New areas, such as nanotechnology, electric cars
Possible future areas of cooperation (US stakeholder consultation)
SME policies
Practical Lessons Learned
Based on experience advancing US-EU regulatory dialogues, the Forum
identified the following “Best Cooperative Practices” in 2006:
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Define scope of cooperation clearly
Identify appropriate mechanisms for cooperation
Cultivate senior-level support for cooperative activity
Provide sufficient resources to support cooperation
Provide transparency and opportunity for stakeholder input
Promote dialogue between own regulators on best cooperative practices
Horizontal Forum Issues: Regulation
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“Common Understanding” of Regulatory Principles
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Transparency and openness, allowing participation by stakeholders
and the public;
Consideration of benefits and costs;
Careful analysis of alternatives, including less stringent and more
stringent;
Selection of least burdensome approach;
Use of performance-based and behaviorally informed approaches;
Avoid unnecessarily divergent or duplicative requirements; and
Evaluate existing regulatory measures on a periodic basis through a
transparent procedure
Horizontal Forum Issues: Regulation (2)
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Improving Existing Mechanisms for Cooperation
 Use of online planning tools;
 Soliciting input from international stakeholders;
 Ensuring comments on proposals to supplement/
modify existing regulatory measures; and
 Exchanging information on ex-post evaluations
and reviews of regulatory measures
Horizontal Forum Issues: Regulation (3)
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Explore New Cooperation Mechanisms
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Explore new ways to use planning tools to facilitate
cooperation;
Expand the use of online planning tools to exchange
information;
Consider publishing an annual notice seeking public
comment; and
Explore additional consultation mechanisms
Status Update
Horizontal Forum Issues: Standards
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Joint Statement on Standards in Regulation
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Each side has a different approach to standards
Need to enhance cooperation so as to minimize
unnecessary divergences and creation of NTBs
Important to enhance transparency and stakeholder
participation, participation in int’l standard setting
Agree to develop proposal to implement these principles
Will encourage trading partners to adopt similar principles
Status update
Sectoral Issues
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Current Issues
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Energy Efficiency
Manufactured Nanomaterials
E-mobility (electric vehicles)
Future Areas of Focus?
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FR notice
Other stakeholder outreach
Toys as a success story
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First meeting of TEC 2007 identified safety of imported products as a
priority for future work; Forum report of 2008 on how to improve
cooperation, including information exchange on unsafe products
USCPSC and EC DG ENTR and DG SANCO established Working
Group on Toy Safety; covers information exchange, regulatory and
standards developments, potential areas for harmonization, new
initiatives to enhance toy safety
Quarterly video-conferences, with contacts between meetings;
resulted in greatly enhanced understanding of our systems
Common challenge of implementing new toy safety regulations (US:
2008 Consumer Product Safety Improvement Act; EU: 2009 Toy
Safety Directive (both upgrade old regs, and require development of
new or upgraded standards)
Toys as a success story (cont’d)
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Current priorities include
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Promote greater convergence of EU and US toy safety standards
Promote global solutions (ISO standards) in line with the high level of
safety required under both systems
Develop common approaches to common issues, like definitions, risk
assessment, traceability, format of declarations of conformity
Develop closer cooperation on enforcement matters, e.g. information
exchange on US recalls and EU market surveillance
Joint outreach and training in China for regulators, manufacturers and
traders
Experience
Through variety of approaches over the past decade, US-EU regulatory
cooperation efforts have grown/expanded:
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Cooperation now deeper and broader – more decentralized and routine
Confidence-building between regulatory counterparts is essential
No “magic wand” – regulatory cooperation is technical, hard work
No “one size fits all” approach – specific context matters
Focus on prospective regulations is far easier than changing existing
regulations
Replicate models that work well – apply to other sectors/dialogues
Near-term, practical results are key to maintain momentum/support
Expectations management: benefits accumulate – robust over time
Political oversight of technical negotiations (involves legislation)
Experience (2)
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Need highest level political will/clear commitment (e.g. TEC) and senior level
implementation (e.g., Forum)
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Note: this is a necessary but not sufficient condition for a successful outcome
Avoid long-standing trade irritants
Understand your limitations (flexibility is key)
Focus on areas with best prospects of success and where net benefits are highest
Resource constraints can create both challenges and opportunities
Don’t waste a good crisis
Ensure all relevant players are aware/involved (e.g., legislatures, States,
regulators, stakeholders)
Stakeholder-driven agenda – ongoing stakeholder involvement
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But provide us with robust data/evidence, not assertions
Experience (3)
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Start as early as possible
Internal coordination matters
“Cheat”
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Use of performance standards, acceptance of more than one standard
that meets regulatory objectives
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Encourage regulator/stakeholder participation in international
standards development, following the coherence principle
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More likely that standards will be performance based, integrate regional
differences, not conflict with each other  minimizes potential for divergence
Use of international systems of conformity assessment
Concluding Panel:
Needed for successful international regulatory cooperation:
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Comparable jurisdictions over the subject matter (to be) regulated
Common powers, including comparable institutional structures and
regulatory competences (involve/talk to the right players)
Shared values on role of government, acceptable risk and issues such as
impact assessment, risk assessment, transparency
Confidence and trust between regulators (normally a national mandate
with focus on domestic policies, not a trade mandate, not used to
cooperate with foreign regulators/authorities (“bottom-up”)
Need for highest level political will/supervision of bureaucratic process
(“top-down”)
Common interest/utility; focused, selective agenda
Resources
Stakeholder driven
Issue of creating new (easier) versus changing old/existing regulations
(harder)
Further Information
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http://www.whitehouse.gov/omb/international_regulatory_cooperatio
n#irc
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http://ec.europa.eu/enterprise/enterprise_policy/inter_rel/eu_us/index
_en.htm