2011 Report on Technical Barriers to Trade Ambassador Ronald Kirk Office of the United States Trade Representative ACKNOWLEDGEMENTS The Office of the United States Trade Representative (USTR) is responsible for the preparation of this report. U.S. Trade Representative Ron Kirk gratefully acknowledges in particular the contributions of Deputy U.S. Trade Representatives Demetrios Marantis, Michael Punke, and Miriam Sapiro; USTR General Counsel Timothy Reif; Chief Agricultural Negotiator Isi A. Siddiqui; Chief of Staff Lisa Garcia; Assistant USTR for Public/Media Affairs Carol Guthrie, Senior Policy Advisor Janis Lazda, Special Assistant Stephen Ostrowski, Director of Speechwriting Jeremy Sturchio, and all USTR staff who contributed to the drafting and review of this report. Thanks are extended to partner Executive Branch agencies, including the Departments of Agriculture, Commerce, Labor, Justice, State, Transportation and Treasury, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the U.S. Consumer Product Safety Commission, the U.S. International Trade Commission, and the Office of Management and Budget. In preparing the report, substantial information was solicited from U.S. embassies around the world and from interested stakeholders. The draft of this report was circulated through the interagency Trade Policy Staff Committee. March 2011 Table of Contents I. Foreword............................................................................................................................................................ 1 II. Executive Summary ....................................................................................................................................... 3 III. Introduction ...................................................................................................................................................... 5 Genesis of this Report ....................................................................................................................................... 5 Central Focus in 2010 ....................................................................................................................................... 6 Overview of Standards-Related Measures ............................................................................................... 6 IV. Overview of Trade Obligations on Standards-Related Measures .............................................. 9 TBT Agreement .................................................................................................................................................... 9 Operation of the TBT Agreement .............................................................................................................. 12 Standards-Related Provisions in U.S. Free Trade Agreements .................................................... 14 V. U.S. Statutory and Administrative Framework for Implementing Standards-Related Trade Obligations ................................................................................................................................................. 17 VI. Standards ........................................................................................................................................................ 21 VII. Conformity Assessment Procedures ................................................................................................... 25 VIII. U.S. Processes for Identifying Standards-Related Trade Barriers and Determining How to Address Them ................................................................................................................................................... 27 IX. U.S. Engagement on Standards-Related Measures in International, Regional, and Bilateral Fora .......................................................................................................................................................... 31 Overview of U.S. Engagement on Standards-Related Measures .................................................. 31 i TBT Committee ................................................................................................................................................. 32 Specific Trade Concerns ........................................................................................................................... 32 Triennial Reviews of the TBT Agreement ........................................................................................ 32 APEC ...................................................................................................................................................................... 35 2011: The U.S. APEC Year ..................................................................................................................... 35 Trans-Pacific Partnership (TPP) ............................................................................................................... 35 Regulatory Cooperation Fora ..................................................................................................................... 40 European Union ........................................................................................................................................... 40 Mexico .............................................................................................................................................................. 43 Canada ............................................................................................................................................................. 44 Doha Round Negotiations Regarding Standards-Related Measures .................................... 44 The Emerging Technologies Interagency Policy Committee ................................................... 46 X. Trends in 2010 ............................................................................................................................................. 49 Regulatory Measures on Goods with Cryptographic Capabilities .............................................. 55 Mandatory Biotech Labeling ....................................................................................................................... 55 Recognition of Conformity Assessment Bodies .................................................................................. 40 Distilled Spirits Regulation .......................................................................................................................... 40 Organic Product Standards ......................................................................................................................... 58 Formula Disclosure Requirements .......................................................................................................... 59 Issues Related to Trade in Halal Products ............................................................................................ 59 Problematic Documentation Requirements ........................................................................................ 60 The Rise of “Voluntary” Measures as Trade Barriers ...................................................................... 61 XI. Country Reports ........................................................................................................................................... 57 ii Background on Trade Concerns Contained in the Country Reports ......................................... 57 Argentina ............................................................................................................................................................. 58 Brazil ..................................................................................................................................................................... 59 China ...................................................................................................................................................................... 63 Colombia .............................................................................................................................................................. 69 The European Union ...................................................................................................................................... 69 India ....................................................................................................................................................................... 75 Indonesia ............................................................................................................................................................. 77 Japan ...................................................................................................................................................................... 79 Korea ..................................................................................................................................................................... 80 Malaysia ............................................................................................................................................................... 83 Mexico ................................................................................................................................................................... 84 Russia .................................................................................................................................................................... 86