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Request for Public Comments Concerning Regulatory Cooperation Between the United States and the European Union That Would Help Eliminate or Reduce Unnecessary Divergences in Regulation and in Standards Used in Regulation That Impede U.S. Exports

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International Trade Administration, Commerce.




The U.S. Government recognizes that economic recovery and job creation will depend significantly on its ability to work collaboratively with key trading partners to promote free and open trade and investment while also protecting public health and safety, the environment, intellectual property, and consumers' rights. In our trade and investment relationship with the European Union, the main impediments to greater trade and investment—and more open foreign markets for U.S. exporters and investors —are not tariffs or quotas, but rather differences in regulatory measures. These regulatory measures—which include standards developed by a government and used in regulation, standards developed by other bodies at the request or direction of a regulator for use in regulation, or proposals to provide a presumption of compliance to technical requirements developed by a government—may be unnecessary and may increase costs for producers and consumers.

With this Notice, the Department of Commerce's International Trade Administration (ITA), in support of the National Export Initiative (NEI) and the U.S.-EU High Level Regulatory Cooperation Forum (HLRCF), and pursuant to the Secretary of Commerce's role as the chair of Trade Promotion Coordinating Committee, is requesting stakeholders assist the Administration identify opportunities for cooperation between the United States and the European Union to reduce or eliminate divergences in regulatory measures that impede trade in goods in the transatlantic marketplace, in ways that may be unnecessary, as well as any existing or emerging sectors that may benefit from transatlantic regulatory cooperation.

For more information on U.S.-EU regulatory cooperation, see the Web site:​omb/​oira_​irc_​europe.


The agency must receive comments on or before June 2, 2011.


Submissions should be made via the internet at under docket ITA-2011-0006. Please direct written submissions to Lori Cooper, Office of the European Union, Department of Commerce, Room 3513, 14th and Constitution Avenue, NW., Washington, DC 20230. The public is strongly encouraged to file submissions electronically rather than by mail.

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Questions regarding this notice should be directed to

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With this notice, the Commerce Department, on behalf of the Administration, is seeking public input to help identify divergences in regulatory measures in the transatlantic marketplace, so that the U.S. Government can work cooperatively with the European Union to address them.

President Obama linked trade to job creation when he announced the National Export Initiative (NEI) in his 2010 State of the Union address and set the ambitious goal of doubling U.S. exports in the next five years to support millions of jobs here at home. To help achieve this goal, the U.S. Government is working to remove unnecessary divergences in regulations and in standards used in regulation between the United States and the European Union. The European Union, with its 27 member countries, is our largest trading partner, accounting for 19 percent of U.S. merchandise exports in 2010.

Since 2005, the U.S. Government has worked with officials from the European Commission, within the framework of the U.S.-EU High Level Regulatory Cooperation Forum (HLRCF), to strengthen regulatory cooperation, to promote better regulation, and to reduce or eliminate unnecessary regulatory differences that hinder trade and reduce competitiveness, when doing so does not compromise those protections Americans expect from their government. In addition, at the conclusion of its December 2010 meeting, the Transatlantic Economic Council, comprised of Cabinet-level officials from the United States and the European Union, endorsed several initiatives aimed at further promoting U.S.-EU regulatory cooperation, including directing the HLRCF to develop a process for identifying, with stakeholder input, sectors in which the United States and the European Union could pursue upstream regulatory cooperation.

In his January 2010 State of the Union address, President Obama announced the NEI to double U.S. exports over five years and support the creation of new jobs. As the President's Export Promotion Cabinet has undertaken to implement the NEI, regional and sectoral plans are being developed to tailor the U.S. Government's NEI efforts based on the realities of trade with key trading partners. For example, bilateral trade between the United States and the European Union was $559.4 billion in 2010. Despite this extensive trade between the United States and the European Union, U.S. exporters indicate that they continue to encounter unnecessary transatlantic divergences in regulatory measures that impede trade.

ITA has developed a Mature Markets Initiative (MMI) to evaluate how best to grow exports, create jobs, and support U.S. business growth in areas where trade is robust. Regulatory cooperation is a key component of the MMI. Accordingly, ITA has identified the European Union as a mature market and will seek ways to ease or eliminate unnecessary differences in regulation and in standards used in regulation that hinder competitiveness and negatively impact trade for U.S. firms, including new-to-market and new-to-export businesses, and particularly for small- and medium-sized enterprises (SMEs).

Trade may be impeded, for example, because countries apply different standards or technical requirements to address common environmental, health, safety, or other concerns with respect to certain products or product categories. In some instances, such divergences may be arbitrary and can lead to delays, Start Printed Page 24861additional costs, and burdens on U.S. suppliers, particularly SMEs, and, in some cases, can make it difficult for U.S. suppliers to penetrate foreign markets. These divergences can also increase regulatory burdens for governments and costs for consumers. In other cases, divergences in regulation and in standards used in regulation, despite the burdens they impose, may be necessary to achieve legitimate objectives such as the protection of the environment and public health and safety.

Cooperation with respect to regulation and standards used in regulation can help reduce unjustified divergences and lower costs and burdens for businesses, especially SMEs, as well as for governments and consumers. For example, when regulators in different countries are allowed legally to share full data, studies, and other information on specific regulatory issues, they are more likely to reach similar conclusions, such as on the risks associated with a particular product, appropriate measures to mitigate those risks, and the costs and benefits associated with alternative regulatory approaches. This can lead regulators in these countries to adopt regulatory measures that are more aligned with each other, allow producers to develop economies of scale, reduce compliance costs associated with divergent regulatory measures, and pass on cost savings to consumers. It is important for regulatory cooperation to be transparent and non-discriminatory, reduce unnecessary costs and burdens on producers and consumers, and continue to fulfill each government's public health, safety, environmental, and other legitimate policy objectives.

Regulatory cooperation may include, e.g., equivalency agreements under which a regulator in one country agrees to recognize another country's standards as equivalent to its own, allowing products to be placed on its market that meet the other country's standards, or mutual recognition agreements under which regulators in each country agree to allow products from the other country to be placed on the market based on tests or certifications carried out in that country. The outcome of any such regulatory cooperation must ensure that each government can continue to meet its legitimate policy objectives and advance consumer interests.

In addition, when regulators cooperate with regard to regulatory measures, their cooperation may serve not only to facilitate trade, but may also help to realize common public policy objectives. For example, when regulators in different countries coordinate their efforts in carrying out product recalls, it can help ensure that defective or unsafe products are promptly removed from the market, thereby increasing consumers' confidence in the products they buy and in the global trading system.

Request for Information: ITA invites public comment on the following possible types of cooperative regulatory activities between the United States and the European Union: Information-sharing agreements; technical assistance; memoranda of understanding, mutual recognition agreements; collaboration between regulators before initiating rulemaking proceedings; agreements to align particular regulatory measures; equivalency arrangements; and accreditation of testing laboratories or other conformity assessment bodies. ITA acknowledges that these types of cooperative agreements and activities are not appropriate in all cases, and that many already exist between certain regulatory agencies of the U.S. government and their counterparts in the European Union, so interested parties are asked to provide a rationale for the proposed use of a particular cooperative approach or specific activity. ITA is also seeking recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the United States and the European Union.

Submitters should be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. In addition, each comment should include, where appropriate: (a) A description of the specific measure or measures that the recommendation would address (e.g., laws or regulations setting out safety or testing requirements for the relevant product or product sector); (b) an Internet link to or a copy of the measure in English and documentation that may assist ITA in understanding the measure; (c) identification of the key markets in the European Union for the product or product sector; (d) a description of how and to what degree the regulatory measures are affecting trade and their related costs, including for SMEs; (e) information that may affect the recommendation's feasibility (e.g., U.S. legal, regulatory, confidentiality, or policy constraints, or any response from stakeholders or U.S. trading partners the recommendation may elicit); (f) estimates of the potential benefits, including for SMEs, that would result from more closely aligning the regulatory measure, as well as a description of the method by which the submitter has calculated the benefits; (g) contact information, if known, for the relevant government and non-government stakeholders in the United States or the European Union; and (h) any other information that may assist ITA in considering the recommendation.

ITA is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the United States and the European Union, is a justifiable focus of enhanced regulatory cooperation. Submitters are encouraged to work with counterparts and other interested stakeholders in the United States and the European Union to submit comments jointly. ITA will give positive consideration to recommendations that demonstrate strong support from stakeholders in both the United States and the European Union.

Requirements for Submissions: In order to ensure the timely receipt and consideration of comments, ITA strongly encourages commenters to make online submissions, using the Web site. Comments should be submitted under ITA-2011-0006. To find this docket, enter the docket number in the “Enter Keyword or ID” window at the home page and click “Search.” The site will provide a search-results page listing all documents associated with that docket number. Find a reference to this notice by selecting “Notice” under “Document Type” on the search-results page, and click on the link entitled “Submit a Comment.” The Web site provides the option of making submissions by filling in a comments field, or by attaching a document. ITA prefers submissions to be provided in an attached document. (For further information on using the Web site, please consult the resources provided on the Web site by clicking on the “Help” tab.)

All comments and recommendations submitted in response to this notice will be made available to the public. For any comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters “BC”. The top of any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL”. Any person filing comments that Start Printed Page 24862contain business confidential information must also file in a separate submission a public version of the comments. The file name of the public version of the comments should begin with the character “P”. The “BC” and “P” should be followed by the name of the person or entity submitting the comments. If a comment contains no business confidential information, the file name should begin with the character “P”, followed by the name of the person or entity submitting the comments.

Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter in the comments themselves. Similarly, to the extent possible, please include any exhibits, annexes, or other attachments in the same file as the submission itself, not as separate files.

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Dated: April 27, 2011.

Michael C. Camuñez,

Assistant Secretary of Commerce for Market Access and Compliance.

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[FR Doc. 2011-10713 Filed 5-2-11; 8:45 am]