In its Interim Report to Leaders, 19 June 2012 (the final report was due end 2012, but still not published as of Feb. 2013), the Co-Chairs EU-U.S. High Level Working Group on Jobs and Growth states on p.3, that “In order to set the most constructive stage for U.S.-EU discussions during the hoped-for negotiations, we believe that the HLWG should immediately establish a consultation process under which the U.S. and EU: (1) would be required to notify each other of pending and new major proposed regulatory initiatives; and (2) would be able to discuss these initiatives in the context of the ongoing negotiations” and “Finally, it is important to recognize that some regulatory barriers and distortions may be so complicated or so deeply embedded in our respective legal, policy and political structures that greater transatlantic regulatory compatibility may not be immediately achievable. Instead of simply setting these issues aside, the negotiations should be used to find new ways to reinforce existing mechanisms like the Transatlantic Economic Council- TEC and the High Level EU-US Regulatory Cooperation Forum – HLRCF“. Areas where EU and US differ includes: hormones in meat, GMOs; energy consumption of cars, nanotechnology and privacy issues. The European Commission General Directorate for Trade has compiled a fact sheet “the Regulatory part” from September 2013 and an initial position paper on “Sanitary and Phytosanitary” (SPS) issues.
Overviews
Public Health and Food Safety Policies and Regulation in the United States / Policy Department Economic and Scientific Policy, June 2013
This briefing note is made of two parts. The first on “Public Health Policy and Regulation in the United States”, the second on “Food Safety Policy and Regulation in the United States”.
Legal Implications of TTIP for the Acquis Communautaire in ENVI Relevant Sectors / Ecologic institute & Lorenzo Vicario, Policy Department A: Economic and Scientific Policy, October 2013
This study discusses the potential impact of the Transatlantic Trade and Investment Partnership agreement on the EU acquis in the areas of the environment and food safety. It recommends, in particular, that the European Parliament pay very close attention to the precise wording of provisions regarding the environment, food safety, and investment set out in the final text to ensure that both parties are able to maintain the environmental and consumer protection standards they deem appropriate, as provided for in the European Commission’s negotiating mandate
DG Enterprise: EU-USA – Regulatory Cooperation
Transatlantic Regulatory Cooperation: A Possible Role for Congress / Raymond J. Ahearn, Specialist in International Trade and Finance. Vincent Morelli, Section Research Manager, Congressional Research Service, December 1, 2009
Since it began nearly two decades ago, transatlantic regulatory cooperation has been mostly limited to the executive branches and regulatory bodies on both sides of the Atlantic. However, the idea of legislators assuming a more proactive role in transatlantic economic and regulatory cooperation is not a new issue
Analysis
US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States / European Journal of Risk Regulation 4/2013: pp. 443-464
The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter’s (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.
The Transatlantic Free Trade Agreement : What’s at Stake for Communities and the Environment / The Sierra Club, Juni 2013
U.S. – EU Regulatory Differences – Environment and Climate Change – Food Safety and Agriculture – Chemical Safety – Increasing Natural Gas Exports and Fracking
Trade, the Precautionary Principle, and Post-Modern Regulatory Process: Regulatory Convergence in the Transatlantic Trade and Investment Partnership / Lucas Bergkamp, Lawrence A. Kogan, European Journal of Risk Regulation 4/2013, pp. 493-507
Europe’s precautionary principle (“PP”) has been identified as a potential obstacle to a successful TTIP outcome. In our view, the TTIP presents a significant opportunity for creating a process for regulatory cooperation, harmonization, and convergence. In this article, we focus on the PP and related differences in regulatory procedures. Specifically, we discuss the PP’s relation to post-modernism, and its influence on EU regulatory procedure and science, highlighting the paradoxes inherent in the PP. To put these issues into perspective, we also review the ‘reality of precaution.’ In light of this analysis, we assess the effectiveness of the trading partners’ attempts to reduce the regulatory divide, and explore what the EU and US can learn from each other. We then proceed to present some recommendations on how they should proceed in the TTIP negotiations.
Transatlantic regulatory cooperation : the shifting rules of the EU, the US and California / Vogel, David, 1947- ; Swinnen, Johan F. M., 1962-, Cheltenham: Edward Elgar, 2011. EP Library Shelfmark 20.12.04 TRA 11
Legal guidelines for cooperation between the EU and American state governments / Daniel Farber — Transatlantic environmental regulation-making : strengthening cooperation between California and the EU / Christina G. Hioureas and Bruce E. Cain — California motor vehicle standards and federalism : lessons for the EU / Ann E. Carlson — Rivers of diversity : water regulation in California and the EU / Gabrielle Bouleau and Matt Kondolf — Reshaping chemicals policy on two sides of the Atlantic : the promise of improved sustainability through international collaboration / Megan R. Schwarzman and Michael P. Wilson — Climate change policy in California : balancing markets versus regulation / Michael Hanemann and Chris Busch — US versus EU biotechnology regulations and comparative advantage : implications for future conflicts and trade / Gal Hochman, Gordon C. Rausser and David Zilberman — Circuits of regulation : transatlantic perspectives on persistent organic pollutants and endocrine disrupting chemicals / Chris Ansell and Jörg Balsiger — How to get out of the transatlantic regulatory deadlock over genetically modified organisms? / Alberto Alemanno — Food labels and the environment : towards harmonization of EU and US organic standards / David E. Winickoff and Kendra Klein — EU-US horizontal regulatory cooperation : mutual recognition of impact assessment? / Anne C. M. Meuwese — Transatlantic regulatory cooperation : conclusions and implications / Axel Marx and Jan Wouters — Lessons learned and suggestions for improving regulatory cooperation between California and the EU / Ian Clark
The international reach of European Union data protection law and the United States: is international trade in a “safe harbour”? / Marios Koutsias, International Trade Law Review and Regulation, Issue 2, 2012
EU and US Regulatory Approaches to Information on Chemicals in Products: Implications for Consumers / Linda Molander and Alison K. Cohen. European Journal of Risk Regulation 4/2012: pp. 521-534 (abstract)
EU-U.S. Horizontal Regulatory Cooperation Two global regulatory powers converging on how to assess regulatory impacts? / Anne Meuwese University of Antwerp Anne.meuwese@ua.ac.be Draft version April 2009
Approaches in the United States, Canada, and the European Union / U.S. Government Accountability Office (GAO), GAO-06-217R, Nov 4, 2005
Stakeholder views
EU Institutions’ views
Hearing: Regulatory coherence and the implementation of EU law in the context of the Transatlantic Trade and Investment Partnership / Legal Affairs Committee, 11-02-2014
Regulatory Coherence and the Implementation of EU Law in TTIP / Alberto Alemanno
Talking Points for EP Committee on Legal Affairs TTIP Workshop / James Killick, Partner, White & Case LLP
U.S. Rulemaking Process / Joseph E. Burke, US EU Mission
Update on the Transatlantic Trade and Investment Partnership (T-TIP) – Hearing on Regulatory Coherence and the Implementation of EU law / Juri report, Feb. 2014 (scroll down)
Members held an exchange of views in Brussels on 16 January 2014 with Ambassador Miriam Sapiro, then Deputy US Trade Representative responsible for US trade negotiations and enforcement in Europe (and who has since resigned from that post – her replacement is yet to be announced), and with Mr Dan Mullaney, Chief T-TIP Negotiator on the US side.
European Parliament resolution of 23 October 2012 on trade and economic relations with the United States
4. Stresses the importance of continuing with the strengthening of transatlantic economic relations, while supporting EU interests, in fields such as environmental, health and animal protection standards, food safety, cultural diversity, labour rights, consumers’ rights, financial services, public services or geographical indications, among others;
11. Recognises that overly burdensome regulatory standards serve as significant barriers to trade, and that additional growth could follow from addressing such barriers; emphasises that an alignment of EU and US regulatory standards should aim at reaching the highest common standard and, thereby, also improve the product safety for consumers; underlines the need to avoid creating new (even if unintended) barriers to trade and investment, especially in key emerging technologies and innovative sectors;
13. Notes the importance of establishing data sharing protocols between the US Consumer Product Safety Commission and the European Commission in order to deal speedily and effectively with unsafe products placed on the market in either region
34. Requests all stakeholders representing the business communities, once these negotiations have been opened, to organise themselves in such a way as to provide maximum support, in a coordinated, broad-based manner, to underpin an open, transparent dialogue to make progress on the initiative; is convinced that dialogues with consumers as well as SMEs will be of particular relevance and should be opened and coordinated without delay to build momentum across all levels behind the negotiations;
US Dep. Agriculture
U.S.-EU Organic Equivalence Arrangement, 2012
A partnership that will recognize the two organic programs as equivalent and allow access to each other’s markets
Congressional Research Service- CRS
The Consumer Product Safety Commission (CPSC) and International Trade: Legal Issues / Brandon J. Murrill, Legislative Attorney, November 5, 2013
Most consumer products within the jurisdiction of the U.S. Consumer Product Safety Commission (CPSC) are imported into the United States. The CPSC is the central, federal authority for the promotion and enforcement of consumer product safety. In 2008, following several well-publicized national recalls of toys and children’s products, many of which contained lead, Congress passed the Consumer Product Safety Improvement Act (CPSIA), which included provisions addressing the CPSC’s role in ensuring the safety of imported and exported consumer products
The U.S.-EU Beef Hormone Dispute
The United States and the European Union (EU) have engaged in a long-standing and acrimonious trade dispute over the EU’s decision to ban hormone-treated meat. Despite an ongoing series of dispute settlement proceedings and decisions by the World Trade Organization (WTO), there is continued disagreement between the United States and the EU on a range of legal and procedural issues, as well as the scientific evidence and consensus concerning the safety of hormone-treated beef
Consumers’ views
Transatlantic Consumer Dialogue (TACD) is a forum of US and EU consumer organisations which develops and agrees on joint consumer policy recommendations to the US government and European Union to promote the consumer interest in EU and US policy making.
TACD Response to Commerce Department Consultation on EU-US Regulatory Cooperation, 08/10/2011
TACD Submission to the TEC Sept 2010, 09/27/2010
Nanotechnologies — Product safety — Smart Grids — Food safety — Tackling obesity and diet-related disease — Tackling divergent approaches — Protecting consumer privacy in the digital age — Intellectual property enforcement — Competition and copyright
Consumer Reports / Consumers Union is a non-profit organization best known as the publisher of Consumer Reports. Its’ mission is to “test products, inform the public, and protect consumers.”. They focus on policy issues related to telecommunications, mass media, vehicle safety, health care, product safety, financial services, investing, food safety, housing, and energy and utility deregulation.
The Overuse of Antibiotics in Food Animals Threatens Public Health, 11/10/12
Stakeholder Presentation of Susan Grant, Director of Consumer Protection / Consumer Federation of America: To Negotiators in the Transatlantic Trade and Investment Partnership, December 18, 2013
“The U.S. – E.U. Free Trade Agreement: Tipping Over the Regulatory Barriers” / Testimony of ITI’s Dean C. Garfield, House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, July 24, 2013
An agreement “should provide effective protection and enforcement of intellectual property rights to create a climate in which innovators are encouraged to invest in the research, development, and commercialization of leading-edge technologies, and promote the dissemination of technologies and services. New and complementary approaches that enable the digital economy to function, balanced to include effective protection of intellectual property, should be encouraged, and should respect principles such as freedom of expression, fair process, and privacy.”
The Consumer Federation of America (CFA) is a non-profit organization founded in 1968 to advance consumer interests through research, education and advocacy. According to CFA’s website, its members are approximately 300 consumer-oriented non-profits, which themselves have a combined membership of 50 million people. It is generally regarded as liberal in the modern American sense of the term, and is associated with the consumer movement.
Comments on the Transatlantic Trade and Investment Partnership, May 9, 2013
Public Citizen is a non-profit, consumer rights advocacy group based in Washington, D.C., United States. Public Citizen was founded by Ralph Nader.
U.S. Polling Shows NAFTA-style Trade Deals Becoming Even More Unpopular, 7 Nov. 2012 Recent polling indicates that American public opinion over the past few years has intensified from broad opposition to overwhelming opposition to NAFTA-style trade deals.
Producers’ views
TransAtlantic Business Dialogue (TABD)
On October 31, 2012 TABD submitted its joint statement along with the Business Roundtable and ERT to the Federal Register Notice USTR-2012-0028 and to the European Commision request for comments earlier today. The submission on regulatory issues for a possible future trade agreement included 2 additional documents (Forging a Transatlantic Partnership for the 21st Century and Letter on Regulatory Compatibility) that were referenced in the joint statement.
Business Roundtable, an association of CEOs leading U.S. companies, amplifies diverse business perspectives on the world’s most difficult challenges. Submission to the European Commission Directorate-General for Trade:Public Consultation on the Future of EU-U.S. Trade and Economic Relations. October 19, 2012
American Chamber of Commerce to the European Union (AmCham EU)
Discriminatory taxation of food and beverages is ineffective and distorts competition, 6 November 2012
AmCham EU is concerned about discriminatory taxes applied to the food sector for the following reasons:
• Food and beverage taxes generate competitive disadvantages;
• Food taxes are regressive in nature and hit lower socio-economic groups hardest;
• There is no evidence demonstrating a positive impact of food taxes on the ‘healthiness’ of people’s diets;
• Punishing specific food products alone would not automatically lead to the elimination of bad diets and lifestyles; and
• Food taxes hit companies that produce locally and could discourage investment in Europe by both European and non-European companies.
AmCham EU’s response to the European Commission Public consultation on the future of EU-US trade and economic relations, 27 September 2012
Regulatory Cooperation and Coherence: — Regulatory Cooperation and Coherence — Common Impact Assessment procedures — Common Impact Assessment procedures
AmCham EU’s Position on the 2013 Ban on Animal Testing, 5 September 2012
• The goal of the testing and marketing bans of the Amendment 7 to the Cosmetic Directive was to eliminate the use of animals for EU cosmetics legislation purposes. The legislator has explicitly specified that the bans apply only to animal tests carried out ‘in order to meet the requirements of this Directive’ (emphasis added).
• There will be no positive impact on animal welfare by banning or refusing data that has been developed to meet EU non-cosmetic or third country regulatory requirements in line with applicable animal welfare standards.
• Refusing this data could run counter to OECD and WTO rules.
AmCham EU’s Position Statementon a Common European Sales Law, 20 August 2012
The American Chamber of Commerce to the European Union (AmCham EU) welcomes the initiatives of the European Commission aimed at strengthening the internal market and easing cross border transactions. From this perspective, AmCham EU supports the Commission’s intention to improve the quality and coherence of European contract law in the framework of the better regulation agenda
State Toxic Chemical Regulations at Risk in Upcoming Trade Negotiations / Oct 3, 2013 by Katie Weatherford, Center for Effective Government
On Oct. 7, the United States and European Union will resume negotiations that began earlier this year over the Trans-Atlantic Free Trade Agreement (TAFTA). Since tariffs and quotas between the U.S. and EU are already quite low, the negotiations will focus primarily on reducing “non-tariff barriers” (such as differences in standards and regulations) to expand trade across the Atlantic.
