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

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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
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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
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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

Saudi Arabia.......................................................................................................................................................87

South Africa........................................................................................................................................................88

Taiwan..................................................................................................................................................................89

Thailand...............................................................................................................................................................90

Turkey ..................................................................................................................................................................91

Vietnam................................................................................................................................................................94

XII. Appendix A: List of Commenters.........................................................................................................97

XIII.Appendix B: List of Frequently Used Abbreviations and Acronyms.....................................99

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I. Foreword

This year the Office of the United States Trade Representative (USTR) publishes its second 

annual Report on Technical Barriers to Trade (TBT Report). This report was created to respond 

to the concerns of U.S. companies, farmers, ranchers and manufacturers, which increasingly 

encounter non-tariff trade barriers in the form of product standards, testing requirements, and 

other technical requirements as they seek to sell products and services around the world. As 

tariff barriers to industrial and agricultural trade have fallen, standards-related measures of this 

kind have emerged as a primary concern.

Governments, market participants and other entities can use standards-related measures as an 

effective and efficient means of achieving legitimate commercial and policy objectives. But 

when standards-related measures are outdated, overly burdensome, discriminatory, or otherwise 

inappropriate, these measures can reduce competition, stifle innovation, and create unnecessary 

technical barriers to trade. These kinds of measures can pose a particular problem for SMEs, 

which often do not have the resources to address these problems on their own. USTR is 

committed to identifying and combating unwarranted technical barriers to U.S. exports, many of 

which are detailed in this report. USTR’s efforts to prevent and remove foreign technical 

barriers serve the President’s goal of doubling U.S. exports by the end of 2014 through the 

National Export Initiative.

Since the last TBT Report was released, the United States has launched new initiatives to 

promote greater international cooperation among regulatory authorities, trade officials, and 

standards experts to prevent the emergence of unjustifiable barriers to U.S. exports. We have 

made progress, for example, in encouraging our trading partners to address unwarranted or 

burdensome technical regulations through the U.S.-EU High-Level Regulatory Cooperation 

Forum, the U.S.-Mexico High-Level Regulatory Cooperation Council, the U.S.-Canada 

Regulatory Cooperation Council, and other fora. We have also taken successful steps to 

eliminate or reduce specific foreign barriers to U.S. exports, such as Indonesia’s rules limiting 

U.S. poultry and meat imports and Mexico’s nutrition labeling requirements that impeded 

exports of American pre-packaged foods, among others. 

This year, USTR will continue to work with other agencies of the U.S. Government, as well as 

interested stakeholders, to encourage U.S. trading partners to remove their unwarranted or 

overly burdensome technical barriers. As always, we will engage all available bilateral, 

regional, and multilateral contexts in our efforts to dismantle unjustifiable barriers to safe, highquality U.S. industrial, consumer, and agricultural exports and strengthen the rules-based trading 

system. For example, in our capacity as host of the Asia Pacific Economic Cooperation (APEC) 

forum in 2011, the United States has made cross-border regulatory cooperation and convergence 

a top priority for action. We look forward to making further progress on behalf of American 

manufacturers, workers, farmers, ranchers, and service providers, as well as families who 

depend on trade-supported American jobs. 

Ambassador Ron Kirk

U.S. Trade Representative

March 2011

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II. Executive Summary

The 2011 Report on Technical Barriers to Trade (TBT Report) is a specialized report focused on 

significant foreign trade barriers in the form of product standards, technical regulations and 

testing, certification, and other procedures involved in determining whether products conform to 

standards and technical regulations. These standards-related trade measures, known in World 

Trade Organization (WTO) parlance as “technical barriers to trade,” play a critical role in 

shaping the flow of global trade. 

Standards-related measures serve an important function in facilitating global trade, including by 

enabling greater access to international markets by small- and medium-sized enterprises 

(SMEs). Standards-related measures also enable governments to pursue legitimate objectives 

such as protecting human health and the environment and preventing deceptive practices. But 

standards-related measures that are non-transparent, discriminatory, or otherwise unwarranted 

can act as significant barriers to U.S. trade. These kinds of measures can pose a particular 

problem for SMEs, which often do not have the resources to address these problems on their 

own. 

This report is intended to describe and advance U.S. efforts to identify and eliminate such 

barriers. The opening sections of this report present an overview of technical barriers to trade 

and the U.S. and international mechanisms for addressing them.1

 Section II provides an 

introduction to standards-related measures, including the genesis of this report and the growing 

importance of standards-related measures in global trade. Section III provides an overview of 

standards-related trade obligations, in particular rules governing standards-related measures 

under the WTO Agreement on Technical Barriers to Trade (TBT Agreement) and U.S. free 

trade agreements. 

Section IV describes the U.S. legal framework for implementing its standards-related trade 

obligations. Section V elaborates on standards, including the role of international standards in 

facilitating trade and fulfilling legitimate public policy objectives and federal agencies’ 

participation in standards development. Section VI elaborates on conformity assessment 

procedures, including federal agencies’ use of conformity assessment and the possibility for 

international systems of conformity assessment to facilitate trade. Section VII describes how 

the U.S. government identifies technical barriers to trade and the process of interagency and 

stakeholder consultation it employs to determine how to address them. 

Section VIII explains how the United States engages with its trading partners to address 

standards-related measures that act as barriers and prevent their creation through multilateral, 

regional, and bilateral channels, including the WTO’s Committee on Technical Barriers to Trade 

(TBT Committee) and cooperative activities under the APEC Subcommittee on Standards and 

 1 For readers seeking a deeper understanding of the specific topics covered in this report, references and hyperlinks 

to additional information are provided throughout the report. To access official documents of the WTO (such as 

those identified by the document symbol “G/TBT/...”) click on “simple search” and enter the document symbol at 

the WTO’s document retrieval website: http://docsonline.wto.org/gen_search.asp?searchmode=simple
4

Conformance, among others. Section IX summarizes current trends relating to standards-related 

measures.

Finally, Section X identifies and describes significant standards-related trade barriers currently 

facing U.S. producers, along with U.S. government initiatives to eliminate or reduce the impact 

of these barriers. The report identifies TBT measures in 17 countries – Argentina, Brazil, China, 

Colombia, India, Indonesia, Japan, Korea, Malaysia, Mexico, Russia, Saudi Arabia, South 

Africa, Taiwan, Thailand, Turkey, and Vietnam – as well as the European Union (EU) and its 27 

Member States. 
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III. Introduction

Genesis of this Report

Shortly after taking office in 2009, President Obama reaffirmed America’s commitment to 

ensuring the effective implementation and enforcement of the WTO’s system of multilateral 

trading rules. The President’s 2009 Trade Policy Agenda vowed an aggressive and transparent 

program of defending U.S. rights and benefits under the rules-based trading system as a key 

element in his vision to restore trade’s role in leading economic growth and promoting higher 

living standards. The President’s Agenda also recognized that non-tariff barriers have grown in 

significance for U.S. exporters seeking access to foreign markets. The President reiterated this 

focus on non-tariff measures in both the 2010 and 2011 Trade Policy Agendas. Two kinds of 

non-tariff measures in particular pose a particular challenge to U.S. exports: sanitary and 

phytosanitary (SPS) measures and standards-related measures, also known as “technical barriers 

to trade” (TBT). 

In 2009, Ambassador Kirk called for intensified monitoring of trading partners’ non-tariff 

measures that act as obstacles to U.S. trade. He also vowed increased engagement to resolve 

trade issues and to help ensure that U.S. trading partners are complying with trade rules –

particularly those rules under the WTO agreements concerning SPS and standards-related 

measures: the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS 

Agreement) and the TBT Agreement. The goal of this intensified monitoring and engagement is 

to help to facilitate and expand trade in safe, high-quality U.S. products.

Ambassador Kirk directed that USTR’s annual reports be used to bring new energy to the 

process of identifying non-tariff measures that act as significant barriers to U.S. exports; to 

provide a central focus for intensified engagement by U.S. agencies in resolving trade concerns 

related to non-tariff barriers; and to document the actions underway to give greater transparency 

and confidence to American workers, producers, businesses, and other stakeholders regarding 

the actions this Administration is taking on their behalf. As such, Ambassador Kirk directed 

USTR to create a new Report on Sanitary and Phytosanitary Measures (SPS Report) and a 

Report on Technical Barriers to Trade (TBT Report). The TBT Report is a specialized report 

dedicated to significant foreign barriers in the form of product standards, technical regulations, 

and conformity assessment procedures (standards-related measures). Previously, standardsrelated measures were addressed by the National Trade Estimate Report on Foreign Trade 

Barriers (NTE Report).2

 

 2 In accordance with section 181 of the Trade Act of 1974 (the 1974 Trade Act), as amended by section 303 of the 

Trade and Tariff Act of 1984 (the 1984 Trade Act), section 1304 of the Omnibus Trade and Competitiveness Act of 

1988 (the 1988 Trade Act), section 311 of the Uruguay Round Trade Agreements Act (1994 Trade Act), and 

section 1202 of the Internet Tax Freedom Act, the Office of the U.S. Trade Representative is required to submit to 

the President, the Senate Finance Committee, and appropriate committees in the House of Representatives, an 

annual report on significant foreign trade barriers. The statute requires an inventory of the most important foreign 

barriers affecting U.S. exports of goods and services, foreign direct investment by U.S. persons, and protection of 

intellectual property rights.
6

The 2011 Report on Technical Barriers to Trade reflects the President’s continuing commitment 

to reduce or eliminate barriers to U.S. exports, a commitment which was reaffirmed in the 

President’s 2011 Trade Policy Agenda and embodied by the National Export Initiative (NEI), an 

Administration initiative to double U.S. exports by 2014. By addressing significant foreign 

trade barriers in the form of standards-related measures, the TBT Report meets the requirements 

under Section 181 of the Trade Act of 1974, as amended, to report on significant foreign trade 

barriers with respect to standards-related measures. A separate report addressing significant 

foreign trade barriers in the form of SPS measures (2011 Report on Sanitary and Phytosanitary 

Measures) is being released in parallel to this report.

The TBT Report includes country reports that identify specific standards-related trade barriers. 

The report also includes general information on standards-related measures, the processes and 

procedures the United States uses to implement these measures domestically, and the tools the 

United States uses to address standards-related measures when they act as unnecessary barriers 

to trade. This general information is provided to assist the reader in understanding the issues

and trade concerns described in the last two sections of the report, as well as the channels for 

resolving them. These last two sections review current trends relating to standards-related 

measures that can have a significant impact on trade and identify and describe significant 

standards-related trade barriers currently facing U.S. producers and businesses, along with U.S. 

government initiatives to eliminate or reduce these barriers. 

Like the NTE Report, the source of the information for the TBT Report includes stakeholder 

comments that USTR solicited through a Federal Register notice, reports from U.S. embassies 

abroad and from other Federal agencies, and USTR’s ongoing consultations with domestic 

stakeholders and trading partners. An appendix to this report includes a list of commenters that 

submitted comments in response to the Federal Register notice. 

Central Focus in 2010

During 2010, the United States succeeded in prompting its trading partners to reduce or 

eliminate a variety of trade restrictive technical barriers identified in last year’s report. The 

United States also stepped up its efforts to help other governments to avoid imposing 

unnecessary standards-related measures, particularly with respect to innovative technologies and 

new areas of regulation, and assist them in strengthening their capacity building to promote 

good regulatory practices. In 2010, the United States also proposed new initiatives in key trade 

and economic forums, including in the WTO, in negotiations to conclude a broad-based TransPacific Partnership (TPP) agreement, and in APEC, to encourage governments to eliminate and 

prevent unnecessary technical barriers to trade. 

Overview of Standards-Related Measures

Today, standards-related measures play a critical role in shaping the flow of global trade. While

tariffs still constitute an important source of distortions and economic costs, the relative role of 

tariffs in shaping global trade has declined due in large part to successful “rounds” of 

multilateral tariff reductions in the WTO and its predecessor, the General Agreement on Tariffs 

and Trade (GATT). Broadly speaking, standards-related measures are documents and 

procedures that set out specific technical or other requirements for products or processes as well 
7

as procedures to ensure that these requirements are met. Standards-related measures have 

gained prominence in international trade because of a desire to:

• ensure the connectivity and compatibility of inputs sourced in global markets; 

• manage the flow of product-related information through complex and increasingly 

global supply chains;

• organize manufacturing or other production processes around replicable routines and 

procedures to yield greater product quality assurance;

• meet important regulatory and societal objectives, such as ensuring product safety, 

preventing deceptive practices, and protecting the environment; and 

• promote more environmentally-sound or socially-conscious production methods. 

Standards-related measures also play a vital role in enabling greater competition by helping

ensure that producers and consumers can purchase components and end products from a wide 

variety of suppliers. These measures also enable more widespread access to technical 

innovations. Standards-related measures can offer particularly pronounced benefits to SMEs

from this perspective. By establishing a common set of technical requirements that producers 

can rely on in manufacturing components and end products, uniform standards and product 

testing procedures can facilitate the diffusion of technology and innovation, contribute to 

increasing buyer-seller confidence, and assist SMEs to participate in global supply chains. 

But when outdated, overly burdensome, discriminatory, or otherwise inappropriate standardsrelated measures are used, they can reduce competition, stifle innovation, and create 

unnecessary obstacles to trade. Even when standards-related measures are used appropriately, 

firms – particularly SMEs – can face significant challenges in accessing information about, and 

complying with, diverse and evolving technical requirements in major export markets. This is 

particularly the case when technical requirements change rapidly or differ markedly across 

markets. 

Standards-related measures can be an effective and efficient means of achieving legitimate 

commercial and policy objectives. For policy makers, industry officials, and other stakeholders, 

the basic question is: how do we ensure that standards-related measures facilitate innovation, 

competition, consumer and environmental protection, and other public policy objectives –

without creating unnecessary obstacles to trade? As supply chains grow increasingly complex, 

governments and other stakeholders must also address the question of how to better align

standards and technical requirements across jurisdictions and markets to help producers comply 

with those requirements, and help goods flow across borders.

The rules, procedures, and opportunities for engagement that international, regional, and 

bilateral trade agreements establish serve as an important foundation for addressing many of 

these questions. The TBT Agreement is the principal agreement establishing multilateral rules 

governing standards-related measures. (Box 1 lays out definitions provided under the TBT 

Agreement for standards-related measures.) U.S. free trade agreements (FTAs) establish 
8

additional rules on these measures with specific trading partners. The TBT Agreement’s rules

are vital in setting the terms on which the United States engages with its trading partners on 

standards-related measures, and U.S. FTAs build on these rules in important ways. These 

agreements are described in more detail in Section III below.

A broad and active agenda of U.S. engagement on many fronts is needed to ensure that foreign 

standards-related measures do not impose unwarranted barriers to trade. USTR leads Federal 

government policy deliberations on these measures through the interagency Trade Policy Staff 

Committee (TPSC). U.S. activities in the WTO are at the forefront of USTR’s efforts to prevent 

and resolve trade concerns arising from standards-related measures. Coordinating with relevant 

agencies through the TPSC, USTR engages with other governments in many venues, including 

those established by U.S. FTAs and through regional and multilateral organizations, such as the 

WTO, APEC and the Organization for Economic Cooperation and Development (OECD). 

USTR also raises standards-related issues in bilateral dialogues with U.S. trading partners. 

These efforts are designed to ensure that U.S. trading partners adhere to internationally-agreed 

rules governing these measures and to reduce or eliminate unnecessary measures of this kind 

that can create barriers for U.S. producers and businesses.

Box 1. Key Definitions in the WTO Agreement on Technical Barriers to Trade

Technical regulation

Document which lays down product characteristics or their related processes and production methods, 

including the applicable administrative provisions, with which compliance is mandatory. It may also 

include or deal exclusively with terminology, symbols, packaging, marking, or labeling requirements as 

they apply to a product, process, or production method.

Standard

Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines,

or characteristics for products or related processes and production methods, with which compliance is not 

mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking, or 

labeling requirements as they apply to a product, process, or production method.

Conformity assessment procedures

Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations 

or standards are fulfilled.

Explanatory note: Conformity assessment procedures include, inter alia, procedures for sampling, testing 

and inspection; evaluation, verification and assurance of conformity; registration, accreditation, and 

approval as well as their combinations.

Source: Annex 1 of the TBT Agreement.

Note: These definitions apply only with respect to products and related processes and production methods, not to 

services.
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IV. Overview of Trade Obligations on Standards-Related Measures

TBT Agreement

The TBT Agreement is designed to ensure that standards-related measures serve legitimate

objectives, are transparent, and do not create unnecessary obstacles to trade. The TBT 

Agreement contains a comprehensive set of obligations for WTO Members on the development 

and use of these measures. It establishes rules on developing, adopting, and applying voluntary 

product standards and mandatory technical regulations – as well as for the conformity 

assessment procedures (such as testing or certification) used to determine whether a particular 

product meets such standards or regulations. These rules help distinguish legitimate standardsrelated measures from protectionist measures, and ensure that testing and other conformity 

assessment procedures are fair and reasonable. 

The TBT Agreement recognizes that WTO Members have the right to take standards-related 

measures necessary to protect human health, safety and the environment at the levels they 

consider appropriate and to achieve other legitimate objectives. At the same time, the TBT 

Agreement imposes a series of rules regarding the development and application of those 

measures. For example, the TBT Agreement requires governments to develop standards-related 

measures through transparent processes, and to base these measures on relevant international 

standards (where effective and appropriate). The TBT Agreement also prohibits measures that 

discriminate against imported products or create unnecessary obstacles to trade. The TBT 

Agreement sets out a Code of Good Practice for both governments and non-governmental 

standardizing bodies to guide the preparation, adoption, and application of voluntary standards. 

The Code is open to acceptance by any standardizing body located in the territory of any WTO 

Member. Box 2 outlines the key disciplines of the TBT Agreement.

Box 2. Key principles and provisions of the TBT Agreement

Non-discrimination: The Agreement states that “in respect of their technical regulations, products imported from 

the territory of any Member [shall] be accorded treatment no less favorable than that accorded to like products of 

national origin and to like products originating in any other country.” (Art. 2.1) The Agreement requires Members 

to ensure that “conformity assessment procedures are prepared, adopted and applied so as to grant TBT Agreement 

access for suppliers of like products originating in the territories of other Members under conditions no less 

favorable than those accorded to suppliers of like products of national origin or originating in any other country, in 

a comparable situation.” (Art. 5.1.1) The Agreement also requires that Members ensure that related fees are 

equitable (Art. 5.2.5) and that they respect the confidentiality of information about the results of conformity 

assessment procedures for imported products in the same way they do for domestic products. (Art. 5.2.4)

Avoidance of unnecessary obstacles to trade: When preparing or applying a technical regulation, a Member must 

ensure that the regulation is not more trade-restrictive than necessary to fulfill the Member’s legitimate objective.

(Art. 2.2) The obligation to avoid unnecessary obstacles to trade applies also to conformity assessment procedures. 

They must not be stricter than necessary to provide adequate confidence that products conform with applicable 

requirements. (Art. 5.1.2)

Better alignment of technical regulations, standards, and conformity assessment procedures: The Agreement 

calls on Members to use relevant international standards, or the relevant parts of them, as a basis for their technical 

regulations and to use relevant international recommendations and guides, or relevant portions of them, as the basis 
10

for their conformity assessment procedures. The Agreement, however, does not require the use of relevant

international standards, guides and recommendations if they would be ineffective or inappropriate to fulfill the 

Member’s “legitimate objectives.” (Arts. 2.4 and 5.4) In addition, Members should participate “within the limits of 

their resources” in the preparation by international standardization bodies, of international standards for products 

for which they either have adopted, or expect to adopt, technical regulation, and in the elaboration of international 

guides and recommendations for conformity assessment procedures. (Art.2.6 and 5.5)

Use of performance-based requirements: Whenever appropriate, product requirements should be set in terms of 

performance rather than design or descriptive characteristics. (Art. 2.8)

International systems of conformity assessment: Members shall, whenever practicable, formulate and adopt 

international systems for conformity assessment and become members thereof or participate therein. (Art. 9.1)

Acceptance of technical regulations as equivalent: Alongside harmonization, the Agreement encourages 

Members to accept technical regulations that other Members adopt as “equivalent” to their own if these regulations 

adequately fulfill the objectives of their own regulations. (Art. 2.7)

Mutual recognition of conformity assessment: The Agreement requires each Member to recognize “whenever 

possible” the results of conformity assessment procedures (e.g. test results or certifications), provided the Member 

is satisfied that those procedures offer an assurance of conformity that is equivalent as its own. (Art. 6.1) (Without 

such recognition, products might have to be tested twice, first by the exporting country and then by the importing 

country.) The Agreement recognizes that Members may need to consult in advance to arrive at a “mutually 

satisfactory understanding” regarding the competences of their respective conformity assessment bodies. (Art. 6.1) 

The Agreement also encourages Members to enter into negotiations to conclude agreements providing for the 

mutual recognition of each other’s conformity assessment results (i.e., mutual recognition agreements or MRAs). 

(Art. 6.3)

Transparency: To help ensure transparency, the Agreement requires Members to publish a notice at an early stage 

and notify other Members through the WTO Secretariat when it proposes to adopt a technical regulation or 

conformity assessment procedure and to include in the notification a brief indication of the purpose of the proposed 

measure. These obligations apply whenever a relevant international standard, guide, or recommendation does not 

exist or the technical content of a proposed technical regulation or conformity assessment procedure is not in 

accordance with the technical content of relevant international standards, guides, or recommendations. In such 

circumstances, Members must allow “reasonable time” for other Members to comment on proposed technical 

regulations and conformity assessment procedures, which the TBT Committee has recommended to be “at least 60 

days” (G/TBT/26), and take comments it receives from other Members into account. (Art. 2.9 and 5.6) The 

Agreement establishes a Code of Good Practice that is applicable to voluntary standards and obligates Members 

and standardizing bodies that have accepted it to publish every six months a work program containing the standards 

it is currently preparing and give interested parties at least 60 days to comment on a draft standard; once the 

standard is adopted it must be promptly published. (Annex 3) The Agreement also requires that all technical 

regulations and conformity assessment procedures be promptly published. (Art. 2.11 and 5.8) In addition, the 

Agreement requires each Member to establish an inquiry point to answer all reasonable questions from other 

Members and interested parties and to provide documents relating to technical regulations, standards, and 

conformity assessment procedures adopted or proposed within its territory. (Art. 10.1) 

Technical assistance: The Agreement calls on Members to provide technical assistance to other Members. (Art. 

11) Technical assistance can be provided to help developing country Members with such matters as preparing 

technical regulations, establishing national standardizing bodies, participating in international standardization 

bodies, and establishing bodies to assess conformity with technical regulations.

Enforcement and dispute settlement: The Agreement establishes the Committee on Technical Barriers to Trade as 

the major forum for WTO Members to consult on matters relating to the operation of the Agreement, including 

specific trade concerns about measures that Members have proposed or adopted. (Art. 13) The TBT Agreement 

provides for disputes under the Agreement to be resolved under the auspices of the WTO Dispute Settlement Body 

and in accordance with the terms of the WTO’s Dispute Settlement Understanding. (Art. 14)
11

Access to information on product-related technical requirements is critical for facilitating trade.

Producers, growers, manufacturers, and other supply chain participants need to know the 

requirements with which their products must comply in order to sell them in prospective 

markets. The TBT Agreement, therefore, requires every WTO Member to establish a national 

Inquiry Point that is able to answer reasonable questions from other Members and interested 

parties concerning its proposed or existing measures, and provide relevant documents, as 

appropriate. It also requires each WTO Member to ensure all standards-related measures that it 

adopts are promptly published or otherwise made publicly available. 

The TBT Agreement requires WTO Members to provide other Members the opportunity to 

participate in the development of mandatory standards-related measures, which helps to ensure 

that standards-related measures do not become unnecessary obstacles to trade.3 In particular, 

the TBT Agreement requires each Member to publish a notice in advance that it proposes to 

adopt a technical regulation or conformity assessment procedure.4 It also requires each WTO 

Member to notify proposed technical regulations and conformity assessment procedures to the 

WTO so that other WTO Members may comment on them in writing. WTO Members are 

required, without discrimination, to take into account these written comments, plus the results of 

any requested discussions of those comments, when finalizing their measures.5

 In 2010 alone, 

WTO Members notified 1,419 new or amended technical regulations and conformity assessment 

procedures to the WTO. Box 3 shows the growth in notifications since 1995.6

 3

 Depending on the WTO Member’s domestic processes, interested parties may participate directly in that 

Member’s process for developing new standards-related measures, for example, by submitting written comments to 

the Member, or indirectly by working with their own governments to submit comments.

 

4 Members typically do this by publishing a notice in an official journal of national circulation or on a government 

website that they propose to adopt a technical regulation or conformity assessment procedure or by publishing the 

full text of the draft measure. 

5 The obligations described in this paragraph apply to measures that have a significant effect on trade and are not 

based on relevant international standards, guides, or recommendations or in circumstances where relevant 

international standards, guides, or recommendations do not exist. In many instances, however, Members, including 

the United States, notify proposed technical regulations and conformity assessment procedures regardless of 

whether they are based on relevant international standards. 

6 WTO Members notify new measures, as well as addenda and corrigenda to previously notified measures. An 

addendum alerts WTO Members that substantive or technical changes have been made to a measure that has been 

previously notified. A corrigendum conveys editorial or administrative corrections to a previous notification.

Other: As noted above, the Agreement sets out a “Code of Good Practice” for preparing, adopting, and applying 

voluntary standards. (Annex 3) Standardizing bodies that Members establish at the central level of government 

must comply with the Code and Members must take reasonable measures to ensure that local government and 

private sector standardizing bodies within their territories also accept and comply with the Code. (Art. 4.1) The 

Code is open to acceptance by any standardizing body in the territory of a WTO Member, including private sector 

bodies as well as public sector bodies. The Code requires Members and other standardizing bodies that have 

accepted it to adhere to obligations similar to those for technical regulations, for example, to ensure that the 

standards they adopt do not create unnecessary obstacles to trade and are based on relevant international standards, 

except where ineffective or inappropriate.

Note: The OECD and WTO have also developed summaries of the TBT Agreement. See Trade Policy Working 

Paper No. 58, Do Bilateral and Regional Approaches for Reducing Technical Barriers to Trade Converge Towards 

The Multilateral Trading System? (OECD (TAD/TC/WP(2007)12/FINAL), WTO Trade Gateway, and TBT 

Committee reports and recommendations.
12

Box 3: Number of TBT Notifications to the WTO (Source: WTO, G/TBT/29)

Article 13 of the TBT Agreement establishes a “Committee on Technical Barriers to Trade” to 

oversee the operation and implementation of the TBT Agreement. The TBT Committee is open 

to participation by all 153 WTO Members. The TBT Committee is one of over a dozen standing 

bodies (others include the Committees on Import Licensing, Antidumping Practices, and Rules 

of Origin, for example) that report to the WTO Council for Trade in Goods. The activities of 

the TBT Committee are described in detail below.

Operation of the TBT Agreement

The TBT Agreement seeks to set out simple rules covering complex requirements developed 

and implemented by disparate bodies (central and local governmental agencies; intergovernmental entities; and non-governmental, national and international standardizing 

organizations). WTO Members’ central government authorities have primary responsibility for 

ensuring compliance with the TBT Agreement, including by taking reasonable measures to 

ensure that local and non-governmental bodies, such as private sector standards developing 

organizations, adhere to the relevant provisions. Further, each Member must inform the TBT 

Committee of the laws, policies, and procedures it has adopted to implement and administer the 

TBT Agreement.7

 

Many Members also notify adopted technical regulations and conformity assessment procedures (regardless of 

whether or not they are based on relevant international standards).

7 See G/TBT/GEN/1/Rev.8 for a list of Members’ submissions on the measures they have taken to implement and 

administer the TBT Agreement. 

0

200

400

600

800

1000

1200

1400

1600

1800

2000

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Notifications Addenda/Corrigenda
13

The quality and coherence of these laws, policies, and procedures – as well as how they are put 

into practice – influence the extent to which standards-related measures in any particular country 

are transparent, non-discriminatory, and avoid creating unnecessary obstacles to trade, as the 

TBT Agreement requires. In practice, sound mechanisms for internal coordination among a 

Member’s trade, regulatory, and standards officials are critical to ensuring the Member 

effectively implements the TBT Agreement. When interested agencies and officials coordinate 

their efforts in developing standards-related measures, it makes it more likely that the 

government will consider alternative technical specifications that may lessen any potential 

adverse effects on trade. 

Further, when governments take account of how the products they propose to regulate are traded 

in global markets, it can make the measures they adopt more effective in fulfilling the objective 

of the regulation. The effectiveness of a WTO Member’s internal coordination also often 

determines the extent to which it is able to resolve specific trade concerns raised by other 

Members. In some developing countries, ineffective internal coordination and a lack of 

established procedures for developing standards-related measures are a key concern. For these 

countries, technical assistance or cooperative efforts to improve internal coordination can be 

vital in helping U.S. exporters sell into these markets.

In discharging its responsibility in overseeing the TBT Agreement, the TBT Committee 

conducts triennial reviews of systemic issues affecting WTO Members’ policies and procedures 

for implementing specific obligations.8

 In the course of these reviews, Members adopt specific 

recommendations and decisions, and lay out a forward-looking work program to strengthen the 

implementation and operation of the TBT Agreement. To advance their understanding of 

systemic issues, Members share experiences and participate in special events and regional 

workshops to explore topics in depth. Recent Committee events have covered Good Regulatory 

Practice, Conformity Assessment, and the Role of International Standards in Economic 

Development. The Committee held the 6th Special Meeting on Information Exchange, in June 

2010, and plans to host a Workshop on Regulatory Cooperation in November 2011.

In addition to its triennial reviews and the related special events and workshops, the TBT 

Committee meets three times a year. At these meetings, Members may raise any specific trade 

concern regarding standards-related measures that other Members have proposed or adopted. 

The Committee’s discussion of these concerns can help to clarify the technical aspects of the 

measures concerned, promote greater understanding of how the measures might affect trade, and 

perhaps even help to resolve the concerns. In 2010, WTO Members raised 61 specific trade 

concerns in the TBT Committee, including, for example, concerns regarding measures relating 

to managing hazards arising from use of chemicals, labeling and other non-safety requirements 

relating to food products, and duplicative or redundant testing requirements on a wide variety of 

goods such as toys and medical devices. WTO Members have underscored the importance of 

the Committee’s regular discussions of specific trade concerns, and agreed that the Committee’s 

work has helped to clarify and resolve trade issues between WTO Members.9

 8 The results of the most recent triennial review are discussed in Section V.

9 See the discussion of the Operation of the Committee in the “Fifth Triennial Review of the Operation and

Implementation of the Agreement on Technical Barriers to Trade under Article 15.4” G/TBT/26.
14

Box 4 shows the number of specific trade concerns WTO Members have raised in the TBT 

Committee since 1995. The general rise in concerns raised over the past few years reflects 

several factors – including an increase in the number of proposed measures that WTO Members 

have notified to the WTO, a heightened focus on standards-related activities, increased concern 

that these measures may be used as a form of disguised protectionism, and an increasing 

perception that discussions in the TBT Committee, as well as bilateral discussions on the 

margins of Committee meetings, can lead to results in addressing trade concerns. For a full 

accounting of the concerns raised in the Committee since 1995, see G/TBT/28.

Box 4: Number of specific trade concerns raised per year in the TBT Committee 

(Source: WTO, G/TBT/29)

Standards-Related Provisions in U.S. Free Trade Agreements10

In U.S. FTAs, the parties reaffirm their commitment to the TBT Agreement, and agree to 

strengthen its key provisions. U.S. FTAs build on the disciplines in the TBT Agreement in 

important ways, including by providing for greater transparency, establishing mechanisms for 

more in-depth consultation on specific trade concerns, and facilitating cooperation and 

coordination with FTA partners on systemic issues. As a result, the U.S. approach to standardsrelated measures in its FTAs is commonly referred to as “TBT plus.”11

 10 This section describes TBT provisions of U.S. FTAs with Australia, Bahrain, Central America and the 

Dominican Republic, Chile, Morocco, Oman, and Peru, all concluded in 2003 or later. Pending FTAs with 

Panama, Korea, and Colombia contain similar TBT provisions. In addition to these FTAs, the NAFTA also 

includes provisions that go beyond those contained in the TBT Agreement, for example, with respect to 

transparency, cooperation with trading partners regarding standards-related measures, and national treatment for 

testing and certification bodies. The U.S. FTA with Singapore also includes TBT provisions that seek to enhance 

the parties’ cooperation on standards-related measures. 

 U.S. FTAs, for example,

11 For a discussion of agreements that promote divergence from multilateral approaches (or “TBT minus”) see

3 6 4 7 12 12 13 12 12 19

26 28 32

6 11

13 5 13

15

20 15 14 12

24

27

32

47

29

4

4 6

11

16

11

17

22

32

27 27

24

36

46

58

75

61

0

10

20

30

40

50

60

70

80

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Previous Concerns New Concerns
15

require governments to publish the full text of their proposed standards-related measures, rather 

than simply publish a notice that it proposes to adopt the measure. In addition, U.S. FTAs 

provide interested parties, as well governments, the opportunity to comment on proposed 

measures. These provisions enable the United States and other FTA partners to engage and 

monitor each other’s proposed measures more closely. 

U.S. FTAs also contain substantive obligations that go beyond those in the TBT Agreement. 

For example, U.S. FTAs require FTA partners to accredit or otherwise recognize U.S. testing 

and certification bodies under no less favorable terms than FTA partners accord their own 

testing and certification bodies. Recent U.S. FTAs, as well as the earlier NAFTA, also build in 

mechanisms (such as special committees) for closer and more enduring engagement and 

cooperation on standards-related measures. These mechanisms can prevent specific trade 

concerns from arising and assist the FTA governments in resolving emerging problems. 

By enhancing understanding of each Party’s respective rulemaking processes and standards and 

conformance infrastructure, these consultative mechanisms can enable early identification of 

potential trade problems and provide opportunities for the FTA partners to discuss technical 

alternatives before a measure is finalized.12 The provisions in U.S. FTAs that provide for more 

timely and robust consultations, enhance the notifications process, and provide for direct 

bilateral engagement on notified measures are particularly important in this regard. 

Like the TBT Agreement, the TBT provisions of U.S. FTAs recognize that FTA partners should 

not be prevented from taking measures necessary to protect public health and safety or the 

environment. At the same time, U.S. FTAs lay out ways in which FTA partners can reduce the 

impact on their bilateral trade stemming from differing regulatory regimes. Several U.S. FTAs 

also contain provisions designed to encourage FTA partners to accept each other’s regulations as 

equivalent to their own, where appropriate.

Lastly, recent U.S. FTAs provide strong support for the U.S. Standards Strategy – which 

establishes a framework for developing voluntary product standards – by formally recognizing 

the TBT Committee’s 2000 Decision on Principles for the Development of International 

Standards.

13 The U.S. experience with the 2000 Committee Decision is described at length in 

G/TBT/W/305. These issues are discussed in more detail in Section V below.

 

Trade Policy Working Paper No. 58, Do Bilateral and Regional Approaches for Reducing Technical Barriers to 

Trade Converge Towards The Multilateral Trading System? (OECD (TAD/TC/WP(2007)12/FINAL).

12 See, for example, G/TBT/W/317 for a discussion of the cooperative standards-related work on automobiles, 

chemicals, food, energy, and other issues under the NAFTA.

13 Decision on Principles for the Development of International Standards, Guides and Recommendations with 

Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part I, 

Section III (pp. 10-12) and Annex B (pp. 37-39).
16

Box 5: Key Standards-Related Provisions in U.S. Free Trade Agreements

The United States has concluded FTAs with a number of countries. While each agreement is unique, many of these 

free trade agreements share common provisions relating to standards-related measures. This box summarizes 

standards-related provisions common to U.S. FTAs with Australia, Bahrain, Central America and the Dominican 

Republic, Chile, Morocco, Oman, and Peru. Pending FTAs with Panama, Korea, and Colombia contain these 

provisions as well.

Affirmation of the TBT Agreement: The FTAs reaffirm the parties’ obligations under the TBT Agreement and use 

the TBT Agreement’s definitions of key terms, such as technical regulation, standard, and conformity assessment 

procedures.

International standards: The FTAs require FTA partners to apply the principles of the 2000 Committee Decision

in determining whether an international standard, guide, or recommendation exists.

Conformity assessment procedures: The FTAs recognize the variety of mechanisms that exist for facilitating 

acceptance of each other’s conformity assessment procedures, and they list specific examples of those mechanisms. 

The agreements also call for FTA partners to intensify their exchange of information regarding these mechanisms; 

require an FTA partner to explain when it will not accept, or negotiate agreements to accept, another partner’s 

conformity assessment results; call for FTA partners to recognize conformity assessment bodies in another partner’s 

territory on a national treatment basis; and require FTA partners to explain any refusal to recognize another party’s 

conformity assessment body.

Transparency: The FTAs state that each party shall permit persons from the other party to participate in the 

development of standards-related measures on terms no less favorable than those it accords to its own persons. 

They also enhance TBT Agreement transparency provisions by requiring that proposals be notified directly to the 

other Party; that objectives be included when notifying proposals; that interested parties as well as the FTA partner 

be provided a meaningful opportunity to comment and to have their comments taken into account in finalizing the 

measure; that 60 days be allowed for comment; that proposals be published or otherwise made available; that 

responses be provided to significant comments received at the time a final measure is published; and that additional 

information be provided about the objectives when requested.

Cooperation: The FTAs provide for FTA partners to intensify their joint work on technical regulations, standards, 

and conformity assessment bodies. They also urge participating governments to identify bilateral initiatives for 

specific issues or sectors.

Information Exchange: The FTAs call on each FTA partner to provide information or explanations regarding 

proposed measures within a reasonable period following a request from another FTA partner.

Administration: Each FTA creates its own committee or subcommittee to monitor application of the agreement’s 

provisions, address specific issues that arise under the agreement, enhance cooperation, and exchange information 

on pertinent developments.

Note: For more information, see http://www.ustr.gov/trade-agreements/free-trade-agreements.
17

V. U.S. Statutory and Administrative Framework for Implementing 

Standards-Related Trade Obligations

The United States maintains a robust system to support implementation of its trade obligations 

on standards-related measures through strong central management of its regulatory regime, an 

effective interagency trade policy mechanism, and public consultation. The legal framework for 

implementing U.S. obligations under the TBT Agreement and standards-related provisions in 

U.S. FTAs includes the Administrative Procedure Act of 1946 (APA), and the Trade 

Agreements Act of 1979 (TAA).14 The APA establishes a process of public participation in 

rulemakings by U.S. agencies through a system of notice and comment. The TAA prohibits 

Federal agencies from engaging in any standards-related activity that creates unnecessary 

obstacles to trade and directs them to consider the use of international standards in rulemaking.

The TAA establishes USTR as the lead agency within the Federal government for coordinating 

and developing international trade policy related to standards-related activities, as well as in 

discussions and negotiations with foreign countries on standards-related matters. In carrying out 

this responsibility, USTR is required to inform and consult with Federal agencies having 

expertise in the matters under discussion and negotiation. The TAA also directs the Secretaries 

of Commerce and Agriculture to keep abreast of international standards activities, to identify 

those activities that may substantially affect U.S. commerce, and to inform, consult, and 

coordinate with USTR with respect to international standards-related activities.

The APA provides the foundation for transparency and accountability in developing Federal 

regulations. The APA requires agencies to undertake a notice and comment process open to all 

members of the public, both foreign and domestic, for all rulemakings, and to take these 

comments into account in the final rule.

15 In accordance with the APA, agencies publish 

proposed technical regulations and conformity assessment procedures and solicit public 

comment in the Federal Register. To fulfill WTO obligations to notify proposed technical 

regulations and conformity assessment procedures, the National Institute of Standards and 

Technology (NIST) in the Department of Commerce serves as the U.S. notification authority. 

NIST officials review the Federal Register and other materials on a daily basis and notify the 

WTO of technical regulations and conformity assessment procedures that agencies propose to

adopt. NIST also serves as the U.S. Inquiry Point for purposes of the TBT Agreement.

The foundation for central regulatory review is Executive Order 12866 – Regulatory Planning 

and Review (E.O. 12866) and the implementing guidance of the Office and Management and 

Budget (OMB) Circular A-4. E.O. 12866 lays out the philosophy, principles, and actions that 

 14 The standards-related provisions of the TAA are codified at United States Code, Title 19, Chapter 13, Subchapter 

II, Technical Barriers to Trade (Standards). 

15The term “rule” refers to “an agency statement of general or particular applicability and future effect designed to 

implement, interpret, or prescribe law or policy....” 5 U.S.C. § 551(4). “Rule making” means the “agency process 

for formulating, amending, or repealing a rule....” 5 U.S.C. § 551(5). These definitions include rules or 

rulemakings regarding technical regulations and conformity assessment procedures. The APA makes exceptions 

for urgent matters, allowing Federal agencies to omit notice and comment, for example, where they find that notice 

and public procedures are impracticable or contrary to the public interest. 5 U.S.C. § 553(b)(3). 
18

guide federal agencies in planning, developing, and reviewing Federal regulations. E.O. 12866 

and Circular A-4 are the primary basis on which good regulatory practice (GRP) has been 

integrated into the Federal regulatory structure. These practices ensure openness, transparency,

and accountability in the regulatory process, and, as a result, help ensure that the United States 

fulfills key TBT Agreement and U.S. FTA obligations. GRP,

16 such as that embodied in E.O. 

12866 and OMB Circular A-4, enables government agencies to achieve their public policy 

objectives efficiently and effectively. GRP is also critical in reducing the possibility that 

governments will adopt standards-related measures that create unnecessary obstacles to trade. 

Under the procedures spelled out in E.O. 12866, prior to adopting any significant regulatory 

action (e.g., a proposed technical regulation) federal agencies must submit it for review to OMB. 

Significant regulatory actions are defined as those with an estimated annual impact on the U.S. 

economy of at least $100 million. OMB reviews federal agencies’ proposed regulatory actions 

and consults with USTR and other agencies as needed. This review is designed to ensure, inter 

alia, that proposed regulatory actions are not duplicative or inconsistent with other planned or 

existing Federal regulatory actions, are consistent with U.S. international trade obligations, and 

take into account the trade impact of proposed regulatory actions. At the conclusion of this 

process, OMB provides guidance to the pertinent agency to ensure that its regulatory actions are 

consistent with applicable law, Presidential priorities, and E.O. 12866’s regulatory principles. 

On January 18, 2011, President Obama issued Executive Order 13563 - Improving Regulation 

and Regulatory Review (EO 15363), which reaffirmed and supplemented E.O. 12866. E.O. 

13563 states that “[the U.S.] regulatory system must protect public health, welfare, safety, and

our environment while promoting economic growth, innovation, competitiveness, and job 

creation....It must allow for public participation and an open exchange of ideas. It must 

promote predictability and reduce uncertainty. It must identify and use the best, most 

innovative, and least burdensome tools for achieving regulatory ends. It must take into account 

benefits and costs, both quantitative and qualitative.” E.O. 13563 sets out certain regulatory 

principles, as well as new requirements designed to promote public participation, improve 

regulatory integration and innovation, increase flexibility, ensure scientific integrity, and 

increase retrospective analysis of existing rules. 

In addition to the statutes and policies outlined above, the National Technology Transfer and 

Advancement Act (NTTAA) and OMB’s implementing guidance to Federal agencies, OMB 

Circular A-119, require Federal agencies to use17 voluntary consensus standards18

 16 For a discussion of good regulatory practices from the perspective of APEC and the OECD, see:

in their 

APEC, “Information Notes on Good Practice for Technical Regulation,” September 2000.

OECD, Cutting Red Tape: National Strategies for Administrative Simplification. Paris, 2006.

OECD, Background Document on Oversight Bodies for Regulatory Reform. Paris: OECD, 2007. 

OECD, Regulatory Impact Analyses: Best Practices in OECD Countries. Paris: OECD, 1997.

OECD, Regulatory Performance: Ex post Evaluation of Regulatory Policies. Paris: OECD, 2003. 

OECD and APEC, APEC-OECD Integrated Checklist on Regulatory Reform. Mexico City, 2005.

17 Circular A-119 defines “use” as the inclusion of a standard in whole, in part, or by reference in a regulation.

18 Circular A-119 states that the following attributes define bodies that develop voluntary consensus standards: 

openness, balance of interests, due process, an appeals process, and consensus. 
19

regulatory activities wherever possible and to avoid using “government-unique” standards.19 

The purpose is to discourage Federal agencies from developing their own standards where 

suitable voluntary consensus standards already exist. In addition, voluntary consensus standards 

can often effectively achieve an agency’s regulatory objectives. The NTTAA and the TAA are 

complementary: The NTTAA directs Federal agencies to look to voluntary consensus standards 

to meet their regulatory objectives, while the TAA directs them to consider using relevant 

international standards. As elaborated in Section V, international standards are those that 

recognized bodies, either intergovernmental or non-governmental, develop in accordance with 

principles such as openness, transparency, and consensus.

For additional information on the laws, policies, and interagency processes through which the 

United States implements the TBT Agreement, see G/TBT/2/Add.2, G/TBT/W/285, and 

G/TBT/W/315. See also the Report on the Use of Voluntary Standards in Support of Regulation 

in the United States presented to the High Level Regulatory Cooperation Forum of the United

States – European Union Transatlantic Economic Council (TEC) in October 2009. For 

additional information on the relationship between technical barriers to trade and GRP, see 

G/TBT/W/287 and USITC Working Paper No ID-24, The Role of Good Regulatory Practice in 

Reducing Technical Barriers to Trade.

 19 Circular A-119 defines “government-unique standards” as standards developed by the government for its own 

uses.

21

VI. Standards

Voluntary standards serve a variety of functions and their use supports world trade, for example 

by ensuring the connectivity and compatibility of inputs sourced in global markets. The TBT 

Agreement has a specific definition of “standard” – a document approved by a recognized body 

that provides, for common and repeated use, rules, guidelines or characteristics for products or 

related processes and production methods for which compliance is not mandatory. Voluntary 

standards can facilitate buyer-seller transactions, spur competition20 and innovation, increase the 

efficiency of production, unify markets, and promote societal goals. When used as the basis for 

establishing a technical requirement in a regulation, voluntary standards can help officials 

harness relevant technology to achieve regulatory goals in a cost effective manner. In the 

United States, responsibility for developing voluntary standards rests almost exclusively, and 

appropriately, with the private sector, as this is where the technical know-how for sophisticated 

products and complex processes resides.21

The TBT Agreement acknowledges the diversity of standardizing bodies, and seeks to minimize 

unnecessary obstacles to trade that can arise from multiple standards for the same product, 

specifications that favor domestic goods over imported ones, lack of transparency, or dominance 

by a region or government in standards development. To promote greater harmonization of the 

technical requirements that WTO Members impose, the TBT Agreement promotes the use of 

and participation in the development of international standards. 

Additionally, the TBT Agreement requires Members to base technical regulations and 

conformity assessment procedures on relevant international standards, guides and 

recommendations, except where they would be inappropriate or ineffective in meeting a 

legitimate objective. The TBT Agreement affords technical regulations based on relevant 

international standards a rebuttable presumption that they are not unnecessary obstacles to trade 

under the TBT Agreement. The TBT Agreement also strongly discourages standardizing bodies 

from developing standards where international standards already exist.

The TBT Agreement does not, however, designate specific standardizing bodies as 

“international.” Instead, in its 2000 Decision on the Principles for the Development of 

International Standards, Guides and Recommendations (2000 Committee Decision), the TBT 

Committee adopted a set of six principles for developing international standards.

22

 20 See 

 The 2000 

Committee Decision is designed to clarify the concept of “international standard” and to advance 

objectives such as greater harmonization of technical requirements across markets. The six 

Standards & Competitiveness: Coordinating for Results: Removing Standards-Related Trade Barriers 

Through Effective Collaboration, International Trade Administration, 2005.

21 Agriculture is a notable exception. USDA maintains several programs, such as the Agricultural Marketing 

Service, for the development of voluntary standards on the quality and identity of agricultural products sold in the 

U.S. market. 

22 Decision on Principles for the Development of International Standards, Guides and Recommendations with 

Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part I, 

Section III (pp. 10-12) and Annex B (on pp. 37-39).
22

principles are: (1) openness; (2) transparency; (3) impartiality and consensus; (4) relevance and 

effectiveness; (5) coherence; and (6) the development dimension. 

It is the policy of the U.S. government to use the term “international standard” to refer to those 

standards developed in conformity with the 2000 Committee Decision principles.23 For 

example, U.S. FTAs require trading partners to apply the 2000 Committee Decision principles 

when determining whether a relevant international standard exists. When WTO Members use 

international standards developed in conformity with the 2000 Committee Decision in their 

technical regulations, it can promote greater global regulatory alignment and reduce the adverse 

trade effects that regulatory divergences can create. Application of principles such as 

consensus, openness, and transparency when developing standards helps ensure standards are 

globally relevant and respond to both technical and regulatory needs. The 2000 Committee 

Decision also helps ensure that all interested parties, including producers and consumers that 

may be affected by a particular standard, can participate in developing it. 

Annex 3 of the TBT Agreement contains a Code of Good Practice for WTO Members and nongovernmental standardizing bodies to follow in preparing, adopting, and applying standards. 

Central government standardizing bodies must adhere to the Code. WTO Members are required 

to take reasonable measures to ensure non-governmental standardizing bodies conform to the 

Code as well. In the United States, the American National Standards Institute (ANSI) has 

accepted the Code of Good Practice on behalf of the over 200 standards developing 

organizations (SDOs) that ANSI has accredited. ANSI, a private sector body, is the coordinator 

of the U.S. voluntary standards system with a membership that consists of standards developers, 

certification bodies, industry, government, and other stakeholders. In coordination with its 

membership, ANSI developed and implements the U.S. Standards Strategy. For more 

information on the ANSI system, see Overview of the U.S. Standardization System. 

ANSI accredits SDOs based on its Essential Requirements. Many elements of these 

requirements mirror the 2000 Committee Decision. The Essential Requirements require each 

SDO to maintain procedures for developing standards that ensure openness, consensus, due 

process, and participation by materially affected interests. ANSI also serves as the U.S. national 

standards body member of the International Organization for Standardization (ISO) and the 

International Electrotechnical Commission (IEC). Federal agency representatives participate 

actively in ANSI policy forums, as well as in the technical committees of ANSI-accredited 

SDOs, on an equal basis as other ANSI members. 

OMB Circular A-119 contains guidance for Federal agencies in participating in the development 

of voluntary standards. Circular A-119 directs Federal agencies to participate in private sector 

standards developing organizations consistent with agency missions and priorities. The 

Interagency Committee for Standards Policy, which NIST chairs, coordinates implementation of 

this guidance. More than 4,000 federal agency officials participate in the private sector 

standards development activities of 497 organizations24

 23 The U.S. experience with the 2000 Committee Decision is described in 

to support regulatory needs, enable 

efficient procurement, and to help devise solutions to support emerging national priorities. It is 

notable, however, that the governments in some regions and countries take a non-technical and 

G/TBT/W/305. 

24 Source: NIST, 2008.
23

more commanding role in standards setting than federal agencies generally do. For example, 

some governments direct their national standards bodies or central government bodies to 

develop voluntary standards to achieve specific regulatory needs.

25

VII. Conformity Assessment Procedures

Conformity assessment enables buyers, sellers, consumers, and regulators to have confidence 

that products sourced in global market meet specific requirements.25 Governments may 

mandate conformity assessment procedures – such as testing, sampling, and certification 

requirements – to ensure that the requirements they have established in standards or regulations 

for a product, process, system, person, or body are fulfilled. Suppliers also use conformity 

assessment procedures to demonstrate to their customers that their products or related processes 

or systems meet particular specifications.

26 

Yet, the costs and delays attributable to unnecessary, duplicative, and unclear conformity 

assessment requirements are frequently cited as a key concern for U.S. exporters.27 Indeed, 

many specific trade concerns raised by the United States in the TBT Committee with respect to 

other WTO Members’ measures center on difficulties associated with the Member’s conformity 

assessment requirements. Governments can reduce or minimize such difficulties by taking into 

account the risks associated with a product’s failure to conform to an underlying standard or 

requirement when choosing the type of conformity assessment procedure to apply with respect 

to that standard or requirement. Governments can also reduce or minimize costs associated with 

conformity assessment by adopting approaches that facilitate the acceptance of the results of 

those procedures (e.g., approaches that allow products to be tested or certified in the country of 

export). The TBT Committee’s list of approaches that facilitate this acceptance is contained in 

G/TBT/1/Rev.9.

In the United States, the NTTAA directs NIST to coordinate the conformity assessment 

activities of Federal, state, and local entities with private sector technical standards activities and 

conformity assessment activities. The goal is to eliminate any unnecessary duplication of these

activities. Pursuant to this statutory directive, NIST issued a Federal Register notice in 2000 

providing guidance to Federal agencies on conformity assessment. It calls for Federal agencies 

to provide sound rationales, seek public comments, look to the results of other government and 

private sector organizations, and use international guides and standards when incorporating 

conformity assessment procedures in their regulations and procurement processes. Today, the 

 25 Conformity assessment procedures take a variety of forms, including, for example, testing, certification, 

registration, inspection, accreditation, and verification. The entities that conduct these procedures are referred to as 

conformity assessment bodies and include such bodies as testing laboratories, certification bodies, and accreditation 

bodies. Testing laboratories, for example, test products to evaluate their performance or product characteristics 

while certification bodies certify that products conform to specific standards or requirements. Accreditation bodies, 

for example, evaluate the competency of testing and certification bodies and verify that they comply with specific 

standards or requirements.

26 For an introduction to conformity assessment, see Breitenberg, Maureen, The ABC’s of the U.S. Conformity 

Assessment System, NIST, 1997. 

27 See Johnson, Christopher, Technical Barriers to Trade: Reducing the Impact of Conformity Assessment 

Measures, U.S. International Trade Commission Working Paper, 2008.
26

conformity assessment standards and guides published by ISO and IEC are known as the 

“CASCO toolbox.” 28

In addition to NIST’s efforts to inform and guide Federal agencies in adopting and applying 

conformity assessment procedures, federal agencies and private sector organizations can look to 

guidance in ANSI’s National Conformity Assessment Principles for the United States. ANSI’s 

principles provide supplemental information designed to promote increased acceptance of U.S. 

products in international markets through the use of competently conducted conformity 

assessment procedures. The TBT Agreement, NIST’s guidance, and ANSI’s principles all 

emphasize the importance of participation and use of international systems of conformity 

assessment in facilitating international trade.

Participation and use of international systems of conformity assessment strengthens these 

international systems and produces global benefits. For example, international systems for 

accreditation play a vital role in allowing products to be tested and certified at sites that are 

convenient to production facilities and reducing duplicative testing and certification 

requirements. International systems for accreditation enable this by establishing procedures and 

criteria that accreditation bodies participating in the system agree to apply when accrediting 

testing, certification, or other conformity assessment bodies. Accreditations issued by such 

entities can, in appropriate circumstances, provide governments, as well as suppliers, assurances 

that a body – regardless of its location – is competent to test and certify products for relevant 

markets.

Examples of international accreditation systems include the International Laboratory 

Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF). ILAC and 

IAF have established voluntary mutual recognition arrangements (MRAs). Under these MRAs, 

accreditation bodies agree to adhere to international standards and other procedures and criteria 

when accrediting testing and certification bodies and subject themselves to a system of peer-topeer review to ensure that they continue to meet MRA requirements. In the United States, 

accreditation bodies that participate in these mutual recognition arrangements are predominately 

private sector entities. Increasingly, federal agencies, such as the Consumer Product Safety 

Commission and the Nuclear Regulatory Commission, are using international systems such as 

ILAC in support of their conformity assessment requirements.

 28 ISO/CASCO is the standards development and policy committee on conformity assessment of ISO.

 
27

VIII. U.S. Processes for Identifying Standards-Related Trade Barriers and 

Determining How to Address Them

The United States also maintains rigorous, interagency processes and mechanisms for 

identifying, reviewing, analyzing, and addressing foreign government standards-related 

measures that act, or may act, as barriers to U.S. trade. USTR coordinates these processes and 

mechanisms through the TPSC and, more specifically, its specialized TBT subgroup, the TPSC

Subcommittee on Technical Barriers to Trade (TPSC Subcommittee). 

The TPSC Subcommittee, comprising representatives from federal regulatory agencies and other 

agencies with an interest in foreign standards-related measures, meets formally at least three 

times a year, but maintains an ongoing process of informal consultation and coordination on all 

standards-related issues as they arise. Representatives of the Subcommittee include officials 

from the Departments of State, Agriculture, and Commerce – as well as officials from OMB and 

federal regulatory agencies, such as the Food and Drug Administration and the Environmental 

Protection Agency. The Departments of Commerce and Agriculture serve as the primary 

conduits for communicating information between U.S. industry and agriculture export interests, 

respectively, and the TPSC Subcommittee.

Information for the TPSC Subcommittee on foreign standards-related measures is collected and 

evaluated on a day to day basis through a variety of government channels including: the TBT 

Inquiry Point at NIST, the Trade Compliance Center (TCC), the Office of Standards Liaison, 

and the U.S. Commercial Service (UCS) in the Department of Commerce; the Foreign 

Agricultural Service (FAS) and its Office of Scientific and Technical Affairs (OSTA) in the 

Department of Agriculture; the State Department’s economic officers in U.S embassies abroad; 

and USTR. U.S. government outreach and consultations with U.S. stakeholders generates much 

of the information supplied through these channels, which are further described below.

To disseminate information to U.S. stakeholders on proposed foreign notifications, NIST 

operates a web-based service, Notify U.S., which automatically notifies registered stakeholders 

of measures proposed and adopted by other WTO Members in sectors of interest. These 

notifications alert U.S. firms and other interested stakeholders of their opportunity to comment 

on proposed foreign measures that may have an impact on their exports. U.S. stakeholders may 

provide their comments directly to the WTO Member concerned, if its domestic processes 

provide for that, or through NIST, which works with relevant Federal agencies to review, 

compile and submit comments to the WTO Member. By providing comments through NIST, 

U.S. stakeholders alert federal agencies to their concerns and can enable advocacy by Federal 

agencies on their behalf. 

In 2010, NIST’s U.S. WTO TBT Inquiry Point and Notification Authority processed and 

distributed over 45,000 information requests, including over 2,500 requests for information on 

standards and over 43,000 requests related to technical barriers to trade. The office distributed 

112 U.S. government and industry comments to other WTO Members, and circulated 43 WTO 

Member comments on U.S. measures, as well as 35 WTO Member replies to U.S. comments, to 

relevant federal agencies. U.S. stakeholders monitor notifications of new or revised measures of 

other WTO Members in sectors of interest through the Notify U.S. early alert program, and 
28

contact U.S. officials through the government channels listed above to obtain further 

information, to contribute to the submission of U.S. comments, and to coordinate follow-up 

actions. NIST’s Inquiry Point and Notification Authority hosted or participated in training for 

six U.S. and foreign visiting delegations interested in learning how a WTO inquiry point 

operates. 

The TCC administers the Department of Commerce’s Trade Agreements Compliance Program 

and coordinates efforts and resources within the Department to systematically monitor, 

investigate, and help ensure foreign governments’ compliance with trade agreements to which 

the United States is a party. The TCC offers an online trade complaint hotline at

www.trade.gov/tcc where exporters can report and obtain assistance in overcoming foreign trade 

barriers. The TCC helps assemble teams of specialists to investigate market access problems, 

including ones involving standards-related measures, as well as develop strategies to address 

them. Compliance teams work with affected companies or industries to establish objectives and 

to craft and implement compliance action plans to achieve market access.

In addition, TCC regularly provides input to the TPSC based on the information on the specific 

trade concerns that it collects and analyzes through this process. This information informs the 

TPSC’s development of the appropriate U.S. position in the various multilateral and bilateral 

forums for addressing standards-related measures. Compliance Officers also provide on-theground assistance at U.S. embassies in China, India, El Salvador, Japan, and at the U.S. Mission 

to the European Union in Brussels. Free, online tools include the texts of more than 270 nonagricultural trade agreements plus a checklist of the kinds of trade barriers that the Program can 

help exporters overcome.

OSTA provides a conduit for queries and comments on foreign standards-related measures in 

the agricultural sector. OSTA monitors developments in relevant export markets, provides 

information on foreign standards-related measures through a range of publications, disseminates 

WTO TBT notifications from foreign governments to interested parties, and provides translation 

services on key export market requirements. OSTA works cooperatively with U.S. industry, as 

well as with technical specialists in its overseas offices and federal regulatory agencies, to 

develop comments and positions on specific foreign standards-related measures. In addition, 

FAS works through relevant international organizations to resolve agriculture-related issues 

arising from foreign standards-related measures.

In addition to these government channels, the TPSC Subcommittee receives information from 

the Industry and Agriculture Trade Advisory Committees (ITAC and ATAC, respectively). The 

ITAC and the ATAC help identify trade barriers and provide assessments regarding the practical 

realities that producers face in complying with technical regulations and conformity assessment 

procedures. USTR and Commerce officials meet at least quarterly with the ITAC on Standards 

and Technical Trade Barriers (ITAC 16), which is composed of cleared advisors from 

manufacturers, trade associations, standards developers, and conformity assessment bodies.29

 29 See

 

USTR also meets with other ITACs and advisory committees to receive advice on TBT issues 

affecting specific industry sectors, such as steel, chemicals, automobiles, processed foods, and 

textiles, or specific regulatory areas, such as labor and the environment.

http://www.ustr.gov/Who_We_Are/List_of_USTR_Advisory_Committees.html.

 
29

In developing the U.S. position on any foreign standards-related measure, the TPSC 

Subcommittee takes into account how the United States regulates the same or similar products. 

Regulatory agency officials on the TBT TPSC Subcommittee also provide important 

information on the technical and scientific aspects of particular foreign standards-related 

measures, as well as insights on cooperative efforts through international organizations that may 

be relevant to the issue. The TPSC Subcommittee factors the views that regulatory agencies 

express into the positions that the United States takes in multilateral, regional, and bilateral trade 

discussions regarding standards-related measures. Particularly in the area of emerging 

technologies where standards-related activities are nascent, the technical, scientific, and policy 

advice that regulatory agencies provide is critical in formulating U.S. views. 

31

IX. U.S. Engagement on Standards-Related Measures in International, 

Regional, and Bilateral Fora

Overview of U.S. Engagement on Standards-Related Measures

The United States maintains a broad and active agenda of engagement with foreign governments 

to prevent unnecessary obstacles to trade and to resolve specific trade concerns arising from 

standards-related measures. As noted above, the TBT Committee is the principal multilateral 

forum for engagement on trade issues relating to standards-related measures. The mechanisms 

for cooperation on these measures in U.S. FTAs also play a vital role in facilitating U.S. efforts 

to prevent and resolve trade concerns. In addition, U.S. agencies seek to prevent potential 

technical barriers from emerging by engaging in multilateral, regional, and bilateral cooperative 

activities, information exchanges, technical assistance, and negotiations on specific agreements. 

These efforts are aimed at helping other governments design effective and well-conceived 

standards-related measures, with the goal of producing better regulatory outcomes and 

facilitating trade. 

U.S. government cooperative efforts and information exchanges with developing countries can 

assist firms in those countries build their capacity to comply with foreign standards-related 

measures. As developing country producers increase their participation in global supply chains, 

they need a better understanding of foreign technical requirements and strategies to consistently 

meet those requirements. Cooperative activities can also serve to prevent localized high-profile 

incidents of the type that can disrupt trade across all markets and damage both producer 

reputations and consumer confidence. Close coordination among trade, regulatory, and 

standards officials with highly specialized technical expertise is required in order to carry out 

cooperation and information exchange initiatives that successfully meet these objectives. The 

United States provides bilateral technical assistance and capacity building to developing 

countries on standards-related activities through the U.S. Agency for International Development 

(USAID), the U.S. Trade and Development Agency (USTDA), and the Commerce Department’s 

Commercial Law Development Program (CLDP), Market Development Cooperator Program 

(NDCP), and NIST. USDA’s FAS also provides technical assistance on standards related to 

food trade. These agencies have broader missions and generally provide standards-related 

capacity building assistance as a component of a specific project or mission. 

To reduce the negative impact on trade from divergences in technical requirements across 

markets, the United States negotiates bilateral, regional, and multilateral MRAs with U.S. 

trading partners. These agreements establish procedures for each party to accept the results of 

conformity assessment procedures for specified products carried out in the other party’s territory 

or to accept the other government’s technical specifications for those products as sufficient to 

meet its own requirements. MRAs with trading partners that have a regulatory approach 

compatible with that of the United States and a similar level of technical capacity can help 

facilitate trade in select sectors where trade flows are significant and technical requirements can 

be complex, such as in the telecommunication equipment sector.

NIST maintains a complete inventory of the government-to-government MRAs to which the 

United States is a party. It also maintains a listing of the accreditation requirements for 
32

conformity assessment bodies under each of these MRAs and a list of conformity assessment

bodies that NIST has designated pursuant to each MRA as competent to perform tests or certify 

products to ensure they conform to the other MRA party’s technical requirements. (The Federal 

Communications Commission (FCC) website provides useful background information on U.S. 

MRAs in the telecommunications sector and examples of how they work.) 

The United States also seeks to reduce foreign technical barriers by concluding “equivalency” 

arrangements with other governments. One recent example is the June 2009 exchange of 

equivalency determinations between USDA and Canada’s Food Inspection Agency on organic 

agricultural products. As a result of that exchange, U.S. producers that a USDA-accredited 

agent certifies as meeting U.S. National Organic Program standards do not need to be certified 

under the Canada’s National Organic Standard in order to market their products in Canada as 

“organic.” The exchange provides for Canadian producers to receive a similar accommodation 

for products they export to the United States.

U.S. engagement on standards-related measures in various international and regional fora is 

detailed below. U.S. bilateral engagement with its trading partners on standards-related 

measures is detailed in individual Country Specific Reports in Section X.

TBT Committee

Specific Trade Concerns

The U.S. government actively seeks to prevent and eliminate technical barriers to trade through 

the TBT Committee, with its focused WTO Member-driven agenda. The Committee dedicates a 

significant portion of each of its three annual meetings to affording Members the opportunity to 

raise specific trade concerns on measures that other Members have proposed or adopted. WTO 

Members may also use Committee sessions to share experiences, case studies, or concerns 

relating to cross-cutting issues regarding how Members are implementing the TBT Agreement. 

The TBT Committee often holds workshops or other events on special topics alongside its 

formal meetings. On the margins of each meeting, Members engage in informal bilateral and 

plurilateral meetings to clarify and resolve specific trade concerns and to discuss how to resolve 

other issues of mutual interest. 

In 2010, the United States raised specific trade concerns regarding 20 to 30 foreign TBT 

measures at each TBT Committee meeting and in the informal meetings it held with individual 

or groups of WTO Members. The details and status of many of the specific trade concerns that 

the United States raised in, and on the margins of, the TBT Committee sessions are described in 

Section X of this report. As elaborated in Section X, U.S. interventions in the TBT Committee, 

and on its margins, have helped resolve a number of standards-related concerns affecting U.S. 

trade.

The Committee’s annual review of its activities is contained in G/TBT/29, which includes a 

thumbnail description of the specific trade concerns that WTO Members raised, as well as 

identifies the Members that raised them. 

Triennial Reviews of the TBT Agreement
33

The TBT Agreement calls for the TBT Committee to review the implementation and operation 

of the Agreement every three years. These triennial reviews provide an important opportunity 

for WTO Members to clarify particular provisions of the Agreement. Triennial reviews have 

resulted in a significant body of agreed recommendations and decisions, contained in 

G/TBT/1/Rev.9, which are intended to strengthen and improve the operation of the TBT 

Agreement. 

In November 2009, the TBT Committee completed its Fifth Triennial Review of the Operation

and Implementation of the Agreement on Technical Barriers to Trade Under Article 15.4. 

Numerous suggestions that the United States put forward for purposes of the review figure 

prominently among the Committee’s recommendations, including regulatory cooperation, good 

regulatory practice, internal coordination, transparency, and international standards. These 

recommendations are set out in G/TBT/26. The Committee also established an important and 

ambitious work program on conformity assessment in the report on the review. The report and 

its recommendations establish the focus of the TBT Committee’s work program.

Regulatory cooperation featured prominently in the discussions under the review. The United 

States advocated for greater regulatory cooperation in a joint submission with its NAFTA 

partners (G/TBT/W/317). Regulatory cooperation is an avenue for reducing unnecessary 

technical divergences as well as for achieving better regulatory outcomes – both of which can 

help to facilitate and expand trade. For example, regulatory efforts that effectively reduce the 

incidence of unsafe products benefit both the consumers who purchase those products as well as 

the producers that produce those products. The TBT Committee supported the proposal from 

the NAFTA countries, and agreed to hold a workshop to explore the variety of approaches to 

regulatory cooperation. The workshop is tentatively scheduled for November 2011. The 

Committee will be looking to use the workshop to identify avenues to promote greater 

regulatory alignment. 

During the review, a U.S. submission on how to identify the need to regulate, G/TBT/W/285, 

also factored into the TBT Committee’s discussions and recommendations as an important 

component of GRP discussions. Other Members showed significant interest in advancing work 

on GRP, with Brazil, Canada, China, Costa Rica, Jordan, Korea, Israel, and New Zealand 

submitting papers and comments relating to GRP issues. GRP carries the potential to help WTO 

Members in the following ways: enhance their capacity for market surveillance; apply risk 

analysis in developing regulation; produce clarity in the definition of regulatory objectives; 

facilitate communication with industry, consumers and other stakeholders; provide a basis for 

effective training; maximize the benefits of trade facilitation; and generally ensure policy 

integrity. Going forward, the TBT Committee will compile guidelines and discuss mechanisms 

for Members to implement GRP. 

In the course of the review, the United States also spearheaded in-depth discussions on the 

benefits and challenges of greater use of international standards. Worldwide use of international 

standards facilitates trade by helping firms achieve economies of scale in production, source 

low-cost global inputs, and achieve greater acceptance for their products across countries. In 

March 2009, the Committee held a workshop on overcoming challenges and instituting best 

practices relating to the development and use of international standards to help firms in 

developing countries participate more fully in global markets. Experts from Peru, Pakistan, 

Brazil, Colombia, Chile, Egypt, and Kenya presented practical case studies illustrating how the 
34

use of international standards yielded positive economic benefits to their economies. Several 

developing country Members stressed the challenges confronting their producers in complying 

with multiple or conflicting standards around the world. Many U.S. exporters strongly support 

the principle that governments should avoid mandating unnecessary local specifications for 

globally traded products. 

Members also reaffirmed the importance during the review of both the TBT Agreement’s Code 

of Good Practice for developing, adopting, and using standards and the 2000 Committee 

Decision on the development of international standards. The Code calls on Members to ensure 

that their standardizing bodies at the central level of government do not adopt standards that 

create unnecessary obstacles to trade, and to take reasonable measures to ensure that 

standardizing bodies at sub-central levels of government as well as private standardizing bodies 

do not produce standards that create unnecessary obstacles to trade. The 2000 Committee 

Decision states that processes for developing international standards should be transparent, 

consensus-based, and open to all interested parties. Both the Code and the 2000 Committee 

Decision seek to avoid duplication in standards development. At the conclusion of the review, 

the TBT Committee agreed to share experiences and examine more closely the ways in which 

Members implement both the Code and the 2000 Committee Decision. 

In previous triennial reviews, the Committee’s work on conformity assessment focused on 

information exchange. In the course of those reviews, the Committee held several events 

addressing conformity assessment30 and developed an indicative list of approaches that 

Members can use to facilitate the acceptance of results of conformity assessment procedures 

performed in other countries (see G/TBT/1/Rev.9). In the Fifth Triennial Review, Members 

agreed to continue to exchange information on this subject, but broadened the scope of that 

exchange to include the criteria, methods of analysis, and concepts that Members use to inform 

their evaluation and choose conformity assessment procedures for specific purposes, including 

in the context of a risk management framework. Further, based on these exchanges, the TBT 

Committee agreed to initiate work on developing practical guidelines on how to choose and 

design efficient and effective mechanisms aimed at strengthening the implementation of the 

conformity assessment provisions of the TBT Agreement.

Finally, during the review, the Committee continued its focus on how Members are carrying out 

those provisions of the TBT Agreement that provide for Members to give notice and comment 

on proposed technical regulations and conformity assessment procedures. The TBT’s notice and 

comment rules, and the requirement for Members to take comments into account in finalizing 

the measures they notify, are fundamental to preventing and minimizing unnecessary obstacle to 

trade. Members discussed and reaffirmed the significant body of recommendations and 

decisions on these transparency procedures that the Committee had established in earlier 

reviews. In addition, reflecting the increase in standards-related regulatory activity of local 

governments (e.g., at the state and provincial level) affecting trade, the Committee called for 

 30 These events were: (i) a Symposium on Conformity Assessment Procedures was held on 8-9 June 1999 

(G/TBT/9, 13 November 2000, Annex 1); (ii) a Special Meeting dedicated to Conformity Assessment Procedures 

was held on 29 June 2004 (G/TBT/M/33/Add.1, 21 October 2004); (iii) a Workshop on Supplier's Declaration of 

Conformity (SDoC) was held on 21 March 2005 (Annex 1 of G/TBT/M/35, 24 May 2005); and, (iv) a Workshop 

on the Different Approaches to Conformity Assessment, including on the Acceptance of Conformity Assessment 

Results, was held on 16-17 March 2006 (G/TBT/M/38/Add.1, 6 June 2006).
35

better coordination between central and local governments to improve Members’ 

implementation of the TBT Agreement’s transparency provisions.

In 2011, the Committee will continue its work based on the conclusions of the Fifth Review.

APEC

2011: The U.S. APEC Year

The APEC 31 forum is the Asia-Pacific region’s premier inter-governmental economic 

organization. Its core mission is to strengthen regional economic integration by addressing 

barriers to trade and investment. APEC’s 21 member economies comprise nearly half the 

world’s population and more than half of the global economy. These member economies 

account for 55 percent of global GDP, purchase 58 percent of U.S. goods exports, and comprise 

a market of 2.7 billion customers. In fact, seven of America’s top 15 trade partners are in 

APEC. As host of APEC in 2011, the United States has an historic opportunity to advance a 

trade and investment agenda that will sustain the economic recovery by supporting the growth in 

trade, investment and jobs in the region. The United States will chair a series of ministerial and 

other meetings throughout 2011, including the Trade Ministers meeting in Big Sky, Montana on 

May 19-20. The APEC year will culminate with a heads-of-state meeting in Honolulu, Hawaii

in November hosted by President Obama.

In its role as APEC chair, the United States will continue to emphasize the importance of setting 

APEC policies to accelerate growth and create jobs across the region by addressing specific 

concerns for improving the trade and investment environment. The United States will also give 

priority to concrete initiatives that will build towards a “seamless regional economy” by 

achieving practical, concrete, and ambitious outcomes in three priority areas:

(1) strengthening regional economic integration and expanding trade; 

(2) promoting green growth; and 

(3) expanding regulatory cooperation and advancing regulatory convergence. 

Under U.S. leadership, standards-related issues will be a key priority in 2011. For example, the 

United States is leading an initiative in 2011 to encourage APEC economies to avoid imposing 

unnecessary technical barriers related to emerging green technologies, including commercial 

green buildings, solar technologies, and smart grid. The United States is also working to 

encourage APEC economies to adopt standards and conformity assessment procedures that 

promote greener growth by applying ISO 50001, an international standard that will establish a 

framework for industrial plants, commercial facilities, or entire organizations to manage their 

energy use. 

 31 The APEC members are Australia, Brunei Darussalam, Canada, Chile, China, Hong Kong China, Indonesia, 

Japan, Korea, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, the Philippines, Russia, Singapore, 

Taiwan, Thailand, Vietnam, and the United States.
36

Additionally, the United States will seek agreement by its APEC partners to take steps to 

strengthen implementation of good regulatory practices, including regulatory impact 

assessments, designed to prevent unnecessary barriers to trade. This initiative fits well with the 

work that APEC has conducted since its inception in 1989 to promote good regulatory practices, 

encourage greater alignment of international standards, reform testing and certification 

programs, and advance development of a standards and conformity assessment infrastructure in 

the region. 

APEC Subcommittee on Standards and Conformance

In 1994, APEC established the Subcommittee on Standards and Conformance (SCSC) with the 

goal of better aligning the divergent approaches to standards and conformance issues that 

economies in the region have adopted. The SCSC works to reduce the negative impact of these 

divergences on trade and investment, as well as to facilitate increased market access through 

improved standards and conformance procedures. The SCSC seeks to improve these measures 

by promoting approaches that embody the APEC principles of market-driven interdependence 

and open regionalism. The SCSC does not develop standards and does not support the use of 

regional standards. Rather, the SCSC seeks to encourage APEC economies to align their 

standards-related measures with international standards. 

The SCSC is unique among inter-governmental forums in that it regularly brings together trade 

policy officials, representatives of national standards bodies, and other technical specialists32 to 

advance standards-related goals through cooperation. Regulatory officials often participate in 

SCSC special events and initiatives. The SCSC also invites private sector representatives with 

specific expertise to participate in its special events. The United States has established several 

public-private partnerships to advance priority issues in the SCSC. These partnerships provide 

the SCSC with invaluable access to technical expertise and resources – and provide critical 

information on the practical realities that producers face in complying with technical 

regulations, and that governments confront in developing standards and using conformity 

assessment procedures. 

The SCSC is a valuable forum for garnering support for policy priorities, conducting capacity 

building activities, and building consensus among APEC economies on standards-related 

measures. The Committee makes use of studies, surveys, workshops, training, and other events

to achieve these objectives. The SCSC work is member-driven, with officials of different APEC 

countries working collaboratively to develop and implement projects and initiatives. These 

efforts are designed to promote greater alignment to international standards, pursue recognition 

arrangements for conformity assessments, encourage cooperation to develop “technical 

infrastructure,” and improve implementation of good regulatory practices, including through 

activities to promote greater understanding and cooperation on regulatory issues. The SCSC 

addresses both TBT and SPS issues.

 32 Representatives from the APEC “Specialized Regional Bodies” (SRBs) participate in the SCSC as technical 

experts. The five APEC SRBs are: the Pacific Area Standards Congress (PASC), the Asia-Pacific Metrology 

Program (APMP), the Pacific Accreditation Cooperation (PAC), the Asia Pacific Legal Metrology Forum 

(APLMF) and the Asia-Pacific Laboratory Accreditation Cooperation (APLAC). For a summary of work of the 

SRBs, see “The Role of the APEC Specialist Regional Bodies: Elements of the Standards and Conformance 

Infrastructure” March 2008.
37

Over the years, the SCSC has made important contributions to advancing progress and 

understanding on the trade aspects of standards-related matters, both in the region and 

internationally. In its work on conformity assessments, the SCSC has published reports and 

surveys on topics such as suppliers’ declaration of conformity, market surveillance, and the 

effectiveness of MRAs. The SCSC established a “Voluntary Alignment Program” that has 

identified priority areas for member economies to align their measures with international 

standards and monitored the progress that each economy has made in adopting international 

standards. The SCSC has also adopted a strategic plan for improving technical infrastructure 

that identifies capacity building priorities for each developing APEC economy in the areas of 

standards, accreditation, laboratory accreditation, metrology, and legal metrology. 

The United States is leading a number of initiatives in the SCSC, including public-private 

partnerships, such as the APEC Toy Safety Initiative and the Partnership Training Institute 

Network (PTIN) of the Food Safety Cooperation Forum (FSCF), both of which are described in 

greater detail below. The United States is continuing its leadership by hosting the SCSC’s 6th

Conference on Good Regulatory Practice, March 1-2, 2011, and by co-chairing the SCSC’s 

Trade Facilitation Task Force (TFTF), which brings trade and technical experts together on a 

regular basis to share information and cooperate on product-related environmental standardsrelated measures.

The APEC Toy Safety Initiative

Following high-profile incidents involving recalls of unsafe toys in 2007, APEC Leaders 

directed their officials to work to strengthen product safety standards and practices in the region 

without creating unnecessary obstacles to trade. The SCSC responded in 2008 by launching the 

U.S.-led APEC Toy Safety Initiative. Co-sponsored by the U.S. Toy Industry Association, the 

goals of the APEC Toy Safety Initiative are to strengthen toy safety, increase transparency, 

promote better regulatory alignment, and reduce unnecessary obstacles to trade that may arise as 

a result of toy safety systems. The Initiative sought to advance these goals through the 

“Regulator Dialogue on Toy Safety,” held in Singapore in August 2009, and the Survey of Toy 

Safety Regulators delivered at the “Open Dialogue on Toy Safety for All Stakeholders,” held in 

conjunction with the Hong Kong Toy Fair in January 2010.33 

In 2011, toy safety regulators from the APEC region met under the auspices of the International 

Consumer Product Safety and Health Organization to review progress on the goals they set in 

2009 seeking to increase alignment of toy safety reference standards in the region. This work 

will continue. 

Partnership Training Institute Network of the Food Safety Cooperation Forum 

Concerns about food safety in the Asia-Pacific region have risen sharply in recent years and 

have spurred a collective mandate from leaders of the APEC countries to improve food safety 

standards and practices in the region without creating unnecessary impediments to trade. In 

response, the SCSC established the FSCF in 2007 with the goal of improving food safety 

 33 All of the agendas, presentations and reports on the APEC Toy Safety Initiative’s activities are available on the 

website of the Toy Industry Association: http://www.toyassociation.org.
38

regulatory systems in APEC economies, including food inspection, assurance, and certification 

systems that are consistent with WTO Members’ rights and obligations under both the SPS and 

TBT Agreements.34 

The FSCF seeks to increase food safety and facilitate trade in safe food by addressing capacity 

building opportunities for APEC member economies in priority areas such as information 

sharing, food safety regulatory systems, and food inspection. In 2008, APEC leaders called for 

increased capacity building to improve technical competence and understanding of food safety 

management among stakeholders in the food supply chain, which include regulators, growers, 

packers, handlers, storage providers, processors, manufacturers, retailers, and food service 

providers. 

In 2008, the United States, in collaboration with stakeholders from the private sector and 

academia, spearheaded the establishment of the Partnership Training Institute Network (FSCF 

PTIN). FSCF PTIN combines the expertise and resources of industry, government, and 

academia to strengthen and augment the FSCF’s efforts in addressing capacity building needs in 

the region. The goal of the FSCF PTIN is to facilitate trade and protect public health by 

building the capacity of stakeholders in the food supply chain to use international standards and 

best practices in food safety management from production to consumption, and by creating a 

network of institutes and experts to conduct training of food safety regulators in international 

best practices in food safety. In 2010, the FSCF PTIN conducted training workshops on the 

following subjects:

• Export Certificates. While the use of export certificates can facilitate trade in food and 

agricultural products, the procedures for export certification have grown increasingly 

more complex and varied as regulators around the region strive to assure food safety 

throughout the supply chain. The training provided by FSCF PTIN to food safety 

regulators on this subject provided guidance on how to avoid imposing unnecessary 

certification requirements, how to create generic certificates, and how to promote the use 

of electronic certification in the region. 

• Food Recall Systems. Training provided by FSCF PTIN on this subject focused on 

helping government officials develop recall protocols for different food industry sectors, 

as well as streamline their recall systems based on experiences in economies with stable 

and effective recall systems. The goal of this work was to better prepare APEC member 

economies to deal with outbreaks and to implement effective and efficient food recalls.

• Food Safety Curricula. The FSCF PTIN hosted a workshop on best practices in the 

development and delivery of food safety curricula, bringing together a core group of 

food safety experts from the APEC economies to address ways to develop and deliver 

enduring food safety training in the region. The group developed a strategy and roadmap 

for reviewing existing publicly available materials, identifying gaps in coverage, and 

using this information to adopt and build a generic set of training materials that can be 

used to meet food safety training priorities identified by APEC member economies.

 34 The FSCF covers both SPS and TBT issues. For convenience, the activities of the FSCF are included in the 2010 

TBT Report rather than 2010 SPS Report. 
39

• Supply Chains. The FSCF PTIN also sponsored a three-day training aimed at helping 

food regulators in APEC economies understand and apply best practices and use 

innovative technologies in developing food safety plans for supply chains. The goal was 

to ensure that suppliers provide products that meet applicable regulatory, legal, and 

contractual food safety standards in the relevant APEC economy. 

Trade Facilitation Task Force (TFTF)

The proliferation and diversity of product-related environmental regulations, particularly those 

of the European Union, prompted the need for an APEC forum to promote information 

exchange and cooperation to reduce the potentially adverse trade impact on APEC economies 

from these emerging technical requirements. In 2006, the SCSC established the Trade 

Facilitation Task Force (TFTF). The TFTF, co-chaired by Korea and the United States, brings 

together trade and technical experts to exchange information on specific trade concerns affecting 

APEC economies (whether imposed by other APEC economies or countries outside the APEC 

region) and to promote cooperation in international standardization activities associated with 

product-specific environmental regulations. Experts from industry, academia, international or 

regional bodies, and other relevant authorities participate in TFTF activities.

In September 2010 the TFTF met in Sendai, Japan to exchange information and promote 

cooperation on the trade and technical aspects of current work related to carbon emission 

estimation and sustainability. 

Trans-Pacific Partnership (TPP) 

The Trans-Pacific Partnership (TPP) is a key initiative through which the United States seeks to 

advance the multi-faceted U.S. trade and investment interests in the Asia-Pacific region by 

negotiating an ambitious, 21st-century regional trade agreement along with Australia, Brunei 

Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam. The TPP has begun 

with this initial group of like-minded countries with the goal of creating a platform for regional 

integration across the region.

In the TPP negotiations addressing standards-related issues, the United States is emphasizing

several key themes, including regulatory transparency, encouraging the use of good regulatory 

practices, and providing for TPP governments to accept the results of conformity assessment 

procedures carried out in TPP partner countries. The overall U.S. objective is to establish rules 

and disciplines for standards-related measures that reduce the likelihood that TPP countries will 

create or maintain unnecessary technical barriers to trade. 

In the U.S. view, open and transparent procedures for developing technical regulations, 

standards, and conformity assessment procedures are key to avoiding unnecessary technical 

barriers to trade. In particular, where regulators provide early notice to interested parties at 

home and abroad that they are considering adopting new measures, the interested parties can 

help regulators obtain the information they need to design the measures in a way that avoids 

placing unnecessary burdens on local and foreign producers. Moreover, when regulators use 

transparent procedures in developing regulations, they also help ensure that both domestic and 

foreign stakeholders will view the final regulations as legitimate. In addition, transparent 

implementation of measures and reasonable compliance periods will enhance legal certainty and 
40

predictability for suppliers and make it easier for them to comply.

Transparent procedures in developing regulations are also vital in crafting high quality, sciencebased regulations. In particular, these procedures help governments avoid adopting unneeded, 

inappropriate, or overly burdensome technical regulations, while enhancing the competitiveness. 

The United States is also working to reach agreement in the TPP negotiations on the principle 

that suppliers do not need to have their facilities inspected more than once or have their products 

tested more than once in order to demonstrate that they comply with technical regulations and 

standards in place in a particular export market. In addition, the United States is seeking 

commitment from each TPP government that it will permit suppliers in other TPP countries to 

allow testing to be carried out by a conformity assessment body of their choice, regardless of 

where it is located, as long as the body meets the importing country’s criteria for approved 

assessment bodies. 

Regulatory Cooperation Fora

The United States participates in three bilateral regulatory cooperation forums aimed at promoting 

regulatory best practices and aligning regulatory approaches in economically significant sectors.

European Union

Last year’s report provided a comprehensive summary of the EU’s approach to standards-related 

measures and its trade-restrictive effects on U.S. exports to the EU (see pages 45-50 of the 2010 TBT 

Report). The EU’s approach, and its efforts to encourage governments around the world to 

adopt its approach, continues to present one of the biggest strategic challenges for the United 

States in the area of standards-related measures. In 2010, U.S. officials worked to develop a 

more comprehensive strategy for addressing this challenge in existing bilateral fora, such as the 

Transatlantic Economic Council (TEC) and the United States – European Union High-Level 

Regulatory Cooperation Forum (HLRCF), to encourage systemic changes in the EU approach. 

The TEC is designed to give high-level political direction to bilateral initiatives aimed at 

promoting increased bilateral trade, job creation, and economic growth through deeper 

transatlantic economic integration. The HLRCF, comprising U.S. and EU regulatory and policy

officials, oversees a program of bilateral cooperation on horizontal and sectoral regulatory 

issues. The group has convened in each of the past three TEC meetings to identify projects for 

the TEC to consider. During its December 2010 meeting, the TEC called for the HLRCF to 

undertake several cross-cutting (or “horizontal) cooperation initiatives, among them: (1) 

developing a shared set of principles and best practices for regulation; (2) exploring mechanisms 

for identifying candidate sectors for upstream regulatory cooperation; and (3) crafting a package 

of joint improvements to each side’s approach to the use of standards in regulation.

Efforts to Develop a Shared Set of Principles and Best Practices

Pursuant to the TEC’s instructions, the United States and the European Commission agreed to 

five regulatory principles to reinforce and improve bilateral regulatory cooperation to ensure 

that regulations in the United States and the EU protect public health, welfare, safety and the 

environment while also promoting trade, economic growth, and job creation. These principles 
41

include the following:

• Transparency and openness, allowing participation by stakeholders and the public;

• Consideration of costs and benefits;

• Careful analysis of alternatives;

• Selection of the least burdensome approach; and

• Use of flexible tools, promoting freedom of choice and free markets.

On the basis of these shared principles, the United States and the European Commission further 

agreed to the following best regulatory practices:

• Regulations should be adopted through a transparent and open process that, to the extent 

feasible, promotes accountability and participation, with adequate time, opportunity, and 

accessible tools (including the Internet) for public comment in advance;

• Regulations should be adopted only after a careful assessment of the costs and benefits 

(both quantitative and qualitative) of regulatory proposals and should be based on the 

best available science and a reasoned determination that the benefits of the chosen 

approach justify the costs;

• Regulations should be adopted only after careful consideration of reasonable 

alternatives, both more stringent and less stringent, including non-regulatory options;

• Regulations should be tailored to impose the least burden on society, consistent with 

achieving regulatory objectives, and to minimize adverse impacts on competition, job 

growth, innovation, entrepreneurship, and international trade and investment;

• Regulations should not impose unnecessarily divergent, burdensome, or duplicative 

requirements between the United States and the EU; 

• To the extent feasible, regulations should promote flexibility and freedom of choice, 

through, for example, disclosure requirements and performance standards rather than 

design standards; and

• Existing regulations should be reevaluated periodically and, to the extent feasible and 

appropriate, modified, expanded, streamlined, or repealed in light of experience.

On the basis of the agreement on principles and best practices, the United States has urged the 

EU to agree to establish new bilateral mechanisms to promote early warning of planned 

regulatory actions and consultation with outside parties, including:

• Use of on-line planning tools and documents to improve transparency and understanding 

of the regulatory lifecycle, and to highlight actions available for public comment; 
42

• Soliciting input from international stakeholders on regulatory actions under review to 

help prevent unnecessary divergence, burdens, and duplicative regulatory requirements, 

including (when feasible and appropriate) meetings with senior-level officials and 

international stakeholders; and

• Ensuring that proposals to supplement or modify existing regulations are made available 

for public comment, and procedures for public comment are open and accessible, with 

comment periods generally lasting at least 60 days. 

The United States has also urged the EU to create new bilateral mechanisms to promote 

regulatory cooperation and collaboration, including by: 

• Exploring new ways to use planning tools and documents to enable more opportunities 

for cooperation and collaboration with foreign governments and external stakeholders, 

and to encourage more advice and more useful comments;

• Expanding the use of on-line planning tools and documents to exchange regulatory 

information and display materials throughout the regulatory lifecycle in real time and in 

an intuitive, graphic manner;

• Including senior officials from the OMB and the European Commission in meetings on 

regulatory issues; and 

• Issuing annual notices to the public to solicit recommendations on potential sectors to 

consider for inclusion in initiatives to promote bilateral regulatory convergence or for 

other types of cooperative activities that the HLRCF should explore.

The United States has also urged the EU to consider establishing bilateral mechanisms for 

enhancing regulatory transparency, including procedures to broaden participation by 

stakeholders and the public in the development of U.S. and EU regulatory measures.

Regulating Nanotechnology

The United States and EU identified nanotechnology as one initial area in which regulatory 

cooperation might be possible. U.S. officials briefed the EU on the U.S. government’s

accelerated and robust efforts to develop a consensus approach to nanotechnology. Among 

other things, U.S. officials discussed with their EU counterparts a common definition of 

“nanomaterial” and the two sides agreed to take a risk-based approach to regulating 

nanotechnology, which they agreed was more appropriate than considering hazards alone. The 

two sides also agreed to base their analyses on the best available science on nanotechnology, 

and to continue to cooperate, including sharing best practices and research.

Voluntary Standards 

During the December 2010 discussion, the United States and EU agreed to “build bridges” 

between their respective approaches on the use of voluntary standards in regulation, despite 
43

maintaining very different overall approaches to standards development and use. In a December 

16, 2010 joint statement, the HLRCF identified as primary areas of focus efforts to enhance 

transparency and meaningful stakeholder participation in each side’s processes for developing 

standards and regulations, and called for the two sides to develop by the next HLRCF meeting a 

set of proposals to implement these principles.

The United States will continue to press these issues with the EU during the remainder of 2011.

Mexico 

In May 2010, President Obama and Mexican President Calderón committed to enhance 

significantly the economic competitiveness and the economic well-being of the United States and 

Mexico through improved regulatory cooperation. The Presidents directed the creation of a 

United States – Mexico High-Level Regulatory Cooperation Council (HLRCC), comprising 

senior-level regulatory, trade, and foreign affairs officials from each country.

The HLRCC will seek to promote several goals, including:

• Making regulations in the two countries simpler and more compatible, increasing 

simplification, and reducing compliance burdens without compromising health, public 

safety, environmental protection, or national security;

• Increasing regulatory transparency to build national regulatory frameworks designed to 

achieve higher levels of competitiveness and promote development;

• Simplifying regulatory requirements through public involvement;

• Improving and simplifying regulation by strengthening their analytic base; and

• Increasing bilateral technical cooperation. 

The HLRCC held its inaugural meeting in Washington, DC on September 13, 2010. Participants

discussed their shared commitment to regulatory cooperation on key issues. The two sides began 

considering sectors with high levels of integration that might be subject to HLRCC focus. 

Participants also discussed systemic issues, such as transparency mechanisms and analytical 

techniques, how the two governments use standards as regulatory tools, and steps the two sides 

could take to provide each other with an “early warning” of significant anticipated regulatory.

In March 2011, the U.S. Department of Commerce’s International Trade Administration (ITA) 

published a Federal Register notice requesting views from the public on cooperative activities 

that the United States should pursue with Mexico under the HLRCC or Canada under the 

parallel Council that the United States and Canada have established (discussed below). U.S. 

officials will consider these suggestions together with the recommendations Canada and Mexico 

elicit in their own public outreach efforts with a view to identifying areas of unnecessary 

regulatory divergences in North American that may be disrupting U.S. exports and addressing 

them in the appropriate Council.
44

Canada 

In February 2011, President Obama and Canadian Prime Minister Harper directed the creation of a 

United States – Canada Regulatory Cooperation Council (RCC), composed of senior regulatory, 

trade, and foreign affairs officials from each government. The RCC has a two-year mandate to 

promote economic growth, job creation, and benefits to U.S. and Canadian consumers and 

businesses by enhancing regulatory transparency and coordination. 

The United States and Canada will work through the RCC to provide early notice of regulations 

with potential cross-border effects, strengthen the analytical basis of their regulations, and help 

make their regulations more compatible. The RCC will focus its work on sectors characterized by 

high levels of integration, significant growth potential, and rapidly evolving technologies.

Doha Round Negotiations Regarding Standards-Related Measures

The United States has tabled three proposals in the WTO’s Doha Round of Trade Negotiations 

on Non-Agricultural Market Access (NAMA) aimed at reducing standards-related non-tariff 

barriers (NTBs). These proposals cover: (1) textiles, apparel, footwear, and travel goods

(TAFT);35 (2) electronic goods;

36 and (3) automotive goods.37 WTO Member “senior officials” 

have set all three of these proposals for priority negotiations as part of the overall NAMA NTB 

negotiations and the proposals were included in the NAMA Chair’s December 2008 negotiating 

text.38

Each of the three proposals seeks to facilitate trade in specific sectors for which U.S. industry 

has expressed particular concern about standards-related NTBs. For example, the TAFT 

proposal grew out of U.S. industry concerns that the differing approaches that WTO Members 

take to labeling requirements and sudden changes in those requirements can impose substantial 

costs and burdens on producers while also increasing the time it takes to bring these products to 

the market. In many cases, these costs are then passed on to importers and consumers. The

three U.S. proposals aim to address sector-specific issues of this nature by building on existing 

TBT Agreement disciplines. In addition, the three U.S. proposals also create new and enhanced 

disciplines in areas such as transparency, good regulatory practice, international standards, and 

conformity assessment procedures, while at the same time ensuring that regulators retain the 

ability to meet legitimate policy objectives. 

During the last year, all three U.S. proposals were discussed in detail among WTO Members, 

with the most significant progress being made on the U.S. textiles proposal and on transparency 

provisions common to all three proposals. The chair of the negotiations created small groups to 

 35 Understanding on the Interpretation of the Agreement on Technical Barriers to Trade with respect to the 

Labelling of Textiles, Clothing, Footwear, and Travel Goods (TN/MA/W/93/Rev.2, 8 November 2010).

36 Understanding on Non-Tariff Barriers Pertaining to the Electrical Safety and Electromagnetic Compatibility 

(EMC) of Electronic Goods (TN/MA/W/105/Rev.3, 26 November 2010).

37 Understanding on Non-Tariff Barriers Pertaining to Standards, Technical Regulations, and Conformity 

Assessment Procedures for Automotive Products (TN/MA/W/120, 9 July 2010).

38 Fourth Revision of the Draft Modalities for Non-Agricultural Market Access (TN/MA/W/103/Rev.3, 6 December 

2008. The list of proposals is in paragraph 24.
45

facilitate greater discussions on these initiatives among the WTO Members with the most 

substantial interest in the respective subject matter. The United States is participating 

vigorously in these small groups with the hope of achieving consensus while also continuing to 

advocate for its autos and electronics proposals. 

Textiles

The TAFT proposal, which the United States introduced along with the EU, Mauritius, Sri 

Lanka, and Ukraine, seeks to facilitate trade in textiles, apparel, footwear, and travel goods 

through provisions that would promote greater alignment of labeling requirements. In this 

manner, the U.S. textiles proposal would reduce costs for suppliers, exporters, and consumers. 

The proposal would promote greater alignment of labeling requirements by encouraging 

Members to limit their labeling requirements to certain subjects (such as care instructions or 

fiber content) while at the same time discouraging Members from imposing other requirements

(such as requirements for labels to be certified or made of certain materials). The U.S. proposal 

would also encourage Members to use non-permanent labels instead of permanent labels where 

appropriate. Finally, the U.S. TAFT proposal calls for strong transparency rules, which are 

discussed in greater detail in the section below. 

Transparency

All three U.S. proposals (autos, electronics, and textiles) set out rules to enhance regulatory 

transparency and promote good regulatory practices. These rules seek to ensure that U.S. 

industry and other relevant stakeholders are able to participate on a non-discriminatory basis in 

the process by which other WTO Members develop standards-related measures by guaranteeing 

that stakeholders could submit comments on proposed regulatory measures, have the relevant

WTO Members take their comments into account, and see a response to their comments no later 

than the date the Member publishes the final measure. These rules will help U.S. stakeholders 

influence the development of standards-related measures that other Members adopt and help 

reduce the chances that those measures will disadvantage U.S. exports. 

 

The U.S. transparency proposals would also increase the likelihood that regulators around the 

world base their regulations on similar data and reach similar conclusions regarding the risks 

associated with a particular product and the appropriate measures to mitigate those risks. In 

addition, the U.S. proposals encourage regulators to develop and adopt better informed and 

effective regulatory measures. For these reasons, the rules set out in the proposal will help U.S. 

producers increase their exports to different markets around the world. 

To achieve these transparency-related goals, the U.S. proposals on autos, electronics, and 

textiles each include provisions that would require WTO Members to notify the TBT Committee 

of the technical regulations and conformity assessment procedures they propose to develop, 

regardless of whether these measures are based on international standards. This would build on 

existing TBT Agreement obligations (which require Members to notify the TBT Committee 

only if they measures they propose are not based on international standards), and would ensure 

that stakeholders can learn of proposed regulations that may affect their ability to export to a 

particular market. In addition, each of the U.S. proposals would provide a greater opportunity 

than is currently guaranteed under WTO rules for interested parties to comment on proposed 

regulations before they are adopted.
46

The U.S. transparency proposals also seek to ensure good regulatory practices in the sectors they 

cover. For example, the proposals require Members regularly to review their relevant technical 

regulations and conformity assessment procedures and ensure that they have adequate domestic 

procedures in place to review the actions their regulators take to apply them. In addition, the

proposals would require Members that are preparing or proposing to adopt a technical regulation 

or conformity assessment procedure to consider the costs of complying with the proposed 

measure. Further, the proposals would require Members to consider regulatory and nonregulatory alternatives before adopting a technical regulation, or conformity assessment 

procedure. 

Autos and Electronics-Specific Provisions

The U.S. autos and electronics proposal contain a number of proposed rules similar to the 

standards-related provisions of U.S. FTAs. Although discussions on these proposals have not 

advanced as far as those for the U.S. proposals on textiles and transparency, the United States 

continues vigorously to advocate for them. 

The U.S. auto and electronics proposals include rules that would encourage standardizing bodies 

around the world to develop standards that are globally and technically relevant and to ensure 

that the procedures these bodies follow to develop standards include a meaningful opportunity 

for U.S. exporters and other stakeholders to provide comments before the standards are adopted. 

In particular, the U.S. proposals would clarify that a standard will only be considered an 

international standard within the meaning of the TBT Agreement if it is developed in 

accordance with the six principles of the 2000 Committee Decision discussed in Section V of 

this report. In addition, these proposals would require WTO Members to apply the same criteria 

and procedures for accrediting or otherwise approving domestic and foreign conformity 

assessment bodies to test and certify products for its market and to accept test results performed 

by competent facilities outside the Member’s territory. 

The U.S. proposal on electronic goods also seeks to commit WTO Members to one of two forms 

of conformity assessment procedures in the areas of electrical safety and electro-magnetic 

compatibility – third party certification or a suppliers’ declaration of conformity. The proposal 

would establish disciplines for both types of procedures that ensure, for example, any product 

testing a Member requires can be performed in the exporting country and that U.S. testing and 

certification bodies are treated no less favorably than conformity assessment bodies located in 

the territories of other WTO Members. 

Finally, the U.S. proposal on autos seeks to encourage Members to (a) participate in the work of 

international standardizing bodies as a way of harmonizing technical regulations and conformity 

assessment procedures for those products; (b) consider other Members’ automotive technical 

regulations and conformity assessment procedures when they determine that there is a need to 

regulate and explain any proposed deviations in substance from relevant international standards; 

and (c) provide at least 18 months for producers to comply with a new technical regulation that 

would require substantial change in automobile design or technology.

The Emerging Technologies Interagency Policy Committee 
47

The United States recognizes the critical importance of enhanced interagency coordination 

in developing regulatory policy for emerging technologies. Emerging technologies promise to 

have significant scientific, economic, and perhaps societal impacts because of their potential to 

revolutionize fields as varied as materials science, electronics, medicine, communications, 

agriculture, and energy. Rapid scientific and technological advances in these fields are resulting 

in a variety of new products and processes with unique and transformational characteristics. But 

full realization of the economic and public benefits of these applications will require open 

consideration of policy questions with the full range of stakeholders, including governments, 

industry, non-governmental organizations, academia, and the public.

 

As a result, in 2010 the Administration formed the Emerging Technologies Interagency Policy 

Coordination Committee (ETIPC), part of an effort to give special attention to technologies so 

new—such as nanotechnology and synthetic biology—that their policy implications are still

being gauged. Created jointly by the White House Office of Science and Technology Policy, 

OMB’s Office of Information and Regulatory Affairs, and USTR, the ETIPC consists of assistant 

secretary-level representatives from about 20 Federal agencies. The ETIPC complements the 

work of the TPSC and the National Science and Technology Council, by providing a forum for 

appropriate and timely consideration of a broad range of policy questions and to coordinate 

positions that Federal agencies may take when engaging on these issues internationally. From a 

trade perspective, ETIPC will help the United States engage in regulatory cooperation activities 

with trading partners, with a view to avoiding the creation of unnecessary divergences in 

regulation and the creation of unnecessary technical barriers to trade in emerging technologies. 

At the first meeting of the Committee in May 2010, the co-chairs outlined several guiding 

principles for the group’s work, including the Administration’s commitment to scientific 

integrity, innovation, and open government, ensuring that the benefits of regulation justify its

costs, and using risk-benefit-based oversight mechanisms that ensure safety without stifling 

innovation, stigmatizing emerging technologies, or creating trade barriers.

49

X. Trends in 2010

The U.S. government actively seeks to prevent and eliminate unnecessary technical barriers to trade 

by participating in a variety of venues and on many different levels. The preceding sections of 

this report reviewed U.S. government engagement in bilateral and multilateral venues on 

specific trade concerns and on systemic issues. Section X provides a summary of many of 

the specific concerns of the United States with standards-related activities in specific 

countries. This section reviews trends that appear across various U.S. trading partners’ 

markets, as well as standards-related systemic issues, that can significantly affect the ability of 

U.S. businesses and producers to access foreign markets.

Regulatory Measures on Goods with Cryptographic Capabilities

A number of U.S. trading partners, including China, India, and the Russian Federation, have adopted 

problematic measures that block or restrict U.S. exports of products with cryptographic capabilities 

for commercial use. As an increasing number of products for commercial use are being designed 

with cryptographic capabilities to protect data integrity and confidentiality, these measures have the 

potential to significantly impede trade in a wide range of industrial products and systems. For 

example, China requires U.S. companies to provide their source codes as a condition for U.S. 

companies to market their products. Likewise, China, India, and Russia all require U.S. companies 

to partner with an indigenous company, thus jeopardizing business proprietary information, or 

require U.S. companies operating in these countries to use a country-specific cipher or algorithm. 

These measures tend to favor or require the use of specific domestic technologies that might not 

offer the strongest protection available, and may lead to the forced transfer of intellectual property. 

Consequently, these measures could stifle innovation and have a chilling effect on trade. 

The United States is working with its trading partners to resolve these specific market access 

concerns and to ensure that other trading partners do not adopt similar troublesome practices in the 

future. U.S. officials will promote non-discrimination, the use of relevant international standards as 

a basis for regulation, and transparency and predictability in the development and implementation of 

measures regarding goods with cryptographic capabilities. Further, the United States is evaluating 

other opportunities to collaborate with its trading partners to help prevent the spread of problematic 

practices in the encryption sphere, including through the TPP negotiations. 

Mandatory Biotech Labeling

A growing number of markets around the world require or have proposed mandatory retail labeling 

for food products that contain or are derived from biotechnology. Details, as well as 

implementation, of the regimes vary from market to market. However, the mandatory nature of 

these regimes has impeded, and in some cases, completely blocked U.S. exports of such food 

products to several countries. Some of the countries imposing mandatory biotech labeling 

requirements include Australia, Brazil, China, EU Member States, Indonesia, Japan, Korea, 

Malaysia, New Zealand, Peru, Russia, Saudi Arabia, Turkey, Ukraine, Thailand, Taiwan, and 

Vietnam. These measures pose a significant problem for U.S. agricultural exports as a result of 

the widespread use of biotechnology to produce corn, cotton, and soybeans, as well as food 

produced or processed from these crops in the United States. In fact, biotechnology crops 
50

represent a significant portion of U.S. agricultural exports, totaling $98.6 billion in 2009. 

Mandatory biotechnology labeling measures in Korea, Turkey, and Vietnam are discussed in 

greater detail in Section X.

Mandatory labeling of food products containing or derived from biotechnology has a negative 

impact on U.S. exports for many different reasons. First, mandatory labeling affects 

consumer impressions of a product subject to the labeling requirement. The fact that certain

trading partners apply mandatory labeling requirements solely to products containing or derived 

from biotechnology creates the impression that these products are somehow different from or less 

safe than similar food that is not labeled. Second, mandatory biotechnology labeling increases

costs for consumers and industry stakeholders that buy food produced using biotechnology. 

Third, many countries lack the infrastructure or mechanisms to implement and enforce their 

mandatory biotech labeling requirements in a consistent and transparent manner, which further 

compounds the negative impact on trade.

In many markets, the combined effect of these problems has caused companies to reformulate 

their products to eliminate the use of ingredients containing or derived from biotechnology. 

The additional costs of searching for alternative ingredients, some of which may be expensive 

or scarce, are often ultimately passed on to the consumer. 

The United States will continue to raise trade-related concerns with mandatory biotechnology 

labeling regimes in 2011. 

Recognition of Conformity Assessment Bodies

Last year’s report included an illustrative list of conformity assessment barriers that U.S. exporters 

and conformity assessment service providers face. For a full description of these, and other 

similar barriers, see pages 52-56 of the 2010 TBT Report. 

U.S. officials continue to believe that conformity assessment barriers are a critical issue, and, as a 

result, the United States is devoting substantial resources to addressing these matters on a countryspecific and systemic basis. These efforts produced some notable successes in 2010. For 

example, in an exchange of letters with the United States, Mexico recognized that, for certain 

electrical products, demonstrating compliance with U.S. electrical safety requirements was 

sufficient for these products to be granted access to the Mexican market without additional testing 

or certification in Mexico. This issue is discussed in greater detail in the Mexico section of this

report. 

Other challenges remain. For example, the China section of this report illustrates efforts by the 

U.S. Department of Commerce to resolve practical problems facing U.S. industry with respect to 

compliance with China’s compulsory certification requirements. Likewise, the Korea section 

details efforts made by U.S. officials to urge Korea to liberalize further its conformity assessment 

regime, using recent successes with lithium-ion batteries and energy efficiency as a template. U.S. 

officials have also redoubled their efforts to target conformity assessment barriers in the context of 

the TPP negotiations. 

 

Distilled Spirits Regulation
51

Barriers for distilled spirits have created significant standards-related trade problems for U.S. 

exporters. For example, the EU maintains a three-year minimum aging requirement for whiskey, 

prohibiting U.S. whiskey products that are aged for a shorter period from being sold or from being 

labeled as “whiskey” in the EU market. The EU’s aging requirement is based on the climatic 

conditions in Scotland and Ireland and thus may be appropriate for the production of Scotch and 

Irish Whiskies. However, this aging period is not appropriate for whiskey produced in other 

climatic conditions, such as those in Kentucky, Tennessee, Indiana, and other U.S. states where 

less aging is required to achieve the same result. Further, recent advances in barrel technology 

have enabled U.S. micro-distillers to reduce the aging time for whiskey produced in the United 

States even further, which also demonstrates the inapplicability of a mandatory three-year aging 

requirement for whiskey.

The EU’s policy on distilled spirits also adversely affects U.S. exports to other markets that are 

following the EU’s lead and adopting similar policies. Israel, for example, recently adopted the 

same minimum aging requirement for blended whiskeys as the EU – even though Israel does not 

produce whiskey – and Colombia is considering doing the same. Colombia also is proposing 

that brandy be aged using the solera method, a system of aging that was developed in Europe and 

is not widely used in the United States. If Colombia adopts this policy, it could significantly 

restrict exports to Colombia of U.S. brandy.

Colombia has proposed requirements for other distilled spirits that could impede U.S. exports, 

including quality and identity requirements for vodka, gin, rum, and whiskey. In particular, 

Colombia is proposing to define these products based primarily on whether they meet certain 

analytical parameters for alcohol content, congener levels, and other factors. These definitions 

would differ significantly from the practice followed by North American and European 

regulators. North American and European definitions rely primarily on differences in the raw

materials used, and production processes. If Colombia adopts this proposal, it could effectively 

bar some U.S. spirits from the Colombian market, such as those with alcohol content levels that 

fall above or below the ranges specified in the proposed Colombian requirements. 

Vietnam has proposed setting maximum limits on aldehydes in distilled spirits – a policy that 

could impact U.S. distilled spirit exports to that country. Aldehydes are naturally occurring 

substances, and therefore are present in many distilled spirits. In addition, there is no widelyaccepted scientific or technical basis for the limits on aldehyde content. The United States, 

along with the EU, raised concerns about this issue with Vietnam, and were successful in 

persuading Vietnam to drop this policy for all distilled spirits. 

In 2010, U.S. producers continued to voice concerns about many other labeling requirements 

for alcoholic beverages that appear to lack a valid scientific basis. For example, U.S. 

producers raised concerns about Brazil’s proposed labeling requirement for distilled spirits, 

Thailand’s warning label proposal for all alcoholic beverages, and a similar proposal by 

Kenya. The United States is investigating these policies and will engage with these 

governments to encourage them to drop or modify their proposals. 

From a broader standpoint, numerous countries are adopting policies that require suppliers 

to develop country-specific labels for spirits and other products, and these countries are 

requiring that this designation be made on a permanent label that is affixed in the country of 

export instead of the importing country. The United States is concerned about the manner in 
52

which this requirement is being imposed and the associated costs. In addition, it is not clear 

whether this requirement will diminish counterfeiting, the purported objective of many 

countries. As such, U.S. officials are evaluating opportunities to address this issue on a 

systemic basis, including through the TPP negotiations. 

More details can be found in the country reports on Brazil, Colombia, Thailand, and 

Vietnam in Section X.

Organic Product Standards

Foreign regulations governing organic products can make exporting U.S. organic products a 

costly and burdensome endeavor and, in some instances, prohibitively so. In the organics sector, 

the United States has negotiated three types of agreements with major trading partners in an 

attempt to facilitate trade in organic products:

• Under a “recognition agreement,” an importing country agrees to recognize USDA’s 

National Organic Program (NOP) to accredit agents within the United States to certify 

products as organic under the importing country’s requirements. The United States has 

negotiated such an agreement with the EU. Similarly, USDA has recognized foreign 

conformity assessment bodies to accredit certifying agents in other countries (Denmark, 

India, Israel, Japan, New Zealand, and the United Kingdom) to certify products as 

organic under the NOP.

• Under an “equivalency arrangement,” the United States and another country agree to 

allow some or all products produced and certified to the exporting country’s organic 

requirements to be sold as organic in the importing country. The United States 

concluded its first equivalency arrangement with Canada, the largest U.S. organics 

trading partner, in 2009.

 

• Under an “export arrangement,” U.S. organics producers can sell their products as organic 

in another market (e.g., Japan, Taiwan), provided that their products meet specific 

requirements of the importing country.

These efforts have been highly effective in facilitating trade in organic products. However, in 

some instances it has not been possible to bridge some, or all, of the differences between U.S. 

and foreign organics requirements using these tools.

For example, Japan’s zero tolerance policy for pesticide and herbicide residues on organic products 

limits U.S. organics exports to Japan. Japan’s ban on alkali extracted humic acid, a substance that 

USDA permits for use on U.S. organic crops, also limits U.S. organics exports. Similarly, 

Korea’s zero tolerance policy for adventitious presence of biotechnology content in organic 

products limits U.S. organics exports. If Korea does not adopt regulations allowing it to 

negotiate one or more of the arrangements outlined above, U.S. organics exports to Korea could 

be further restricted beginning in January 2013.

U.S. officials continue to engage with trading partners in an attempt to resolve these issues and 

to prevent new issues from arising. In May 2010, the United States and the EU began 
53

negotiations on a possible equivalency arrangement. The United States also hopes to begin 

positive engagement with Korea on an equivalency arrangement, following a successful effort to 

persuade Korea to allow U.S. organics products to remain in its market at least through January 

2013. The United States is also investigating concerns raised by U.S. producers regarding 

China’s organic standards. 

Formula Disclosure Requirements

During 2010, many countries began requiring the disclosure of confidential business 

information as a condition of entry for food products into their markets. Some of these 

measures, such as those adopted by Brazil, Indonesia, and Japan, require that labels not only 

list a product’s ingredients but also the percentages for each such ingredient. Other countries, 

such as Argentina, Chile, China, Turkey, and Venezuela, adopted measures that require 

companies to disclose a product’s precise recipe or formula. Ecuador has proposed adopting a 

similar requirement. 

In the United States, food containers must include nutritional labels that list ingredients in the 

order of their amounts in the product, but not to disclose the exact percentages or the formula. 

While some countries may require additional disclosures with the goals of ensuring the quality 

and safety of imported food products, other food safety and quality assurance mechanisms are 

available that can achieve the same objectives without compromising proprietary formulas. 

U.S. officials will continue to work bilaterally and in the TBT Committee to protect U.S. food 

industry’s proprietary business information and intellectual property and to provide trading 

partners, as needed, with suggested alternative measures to ensure product safety and quality.

Issues Related to Trade in Halal Products

U.S. industry continues to face market access barriers for halal products. While the Codex 

General Guidelines for Use of the Term “Halal”39 are helpful in setting out basic principles,

governments have established halal standards that vary significantly based on which of the four 

predominant Islamic schools of thought a country embraces. U.S. industry has encountered 

difficulties in exporting halal products because of differences in how countries regulate 

slaughtering, handling and transportation, labeling, and certification for halal purposes, as well 

as when governments exceed the Codex halal guidelines. 

As one example, Malaysia has adopted a standard that would require halal food to be processed 

in dedicated halal facilities, whereas the Codex standard recognizes food as halal if it is

processed on a dedicated line within a facility that produces non-halal products. Likewise, 

Indonesia shut down imports of U.S. poultry last year by abruptly terminating its recognition of 

existing halal certifiers and establishing a new list of certifiers without notice. Last year, 

Indonesia also attempted to apply halal standards to pharmaceuticals, over-the-counter 

medicines, and cosmetics, which could have resulted in a de facto ban on imports of certain 

varieties of these products that contain porcine or alcohol. 

While some governments have attempted to frame their halal rules as a food safety issue, the 

United States has consistently viewed halal as a process/quality standard with no inherent food 

 39 CAC/GL 24-1997
54

safety component. The U.S. view is supported by the Codex halal guidelines. The United 

States has used the WTO TBT Committee to raise its concerns with halal implementation issues, 

and has been successful in many cases. For example, the United States persuaded Indonesia to 

withdraw its attempt to apply halal standards to pharmaceuticals, over-the-counter medicines, 

and cosmetics in 2010. In addition, U.S. efforts ensured that Indonesia recognized four U.S. 

poultry certifiers as halal certifiers for U.S. poultry, reopening the market to U.S. halal poultry 

products. The United States is continuing to engage with Indonesia and Malaysia on these 

issues in 2011, as well as with other countries that maintain or are considering adopting similar 

requirements. 

Problematic Documentation Requirements 

Across industry sectors, U.S. exporters have faced documentation requirements as a condition 

for market entry. These requirements may raise costs for U.S. exporters or serve as a barrier to 

entry. For example:

• Brazil, China, Israel, Japan, Russia, Switzerland, Thailand, Turkey, Venezuela, among 

other countries, require certificates of analysis from U.S. exporters of wine, even when 

exporters already hold certificates verifying that their wines conform to both U.S. and 

the importing country’s standards. Often a country will require that these certificates be 

an original document issued by U.S. government officials or officially accredited 

organizations from the country of importation. In Russia, for example, a U.S. winery 

may be required to pay as much as $5,000 for the two certificates required for hygiene 

and the Gosstandart Russia Certificates of Conformity to wine standards. 

• U.S. industry has raised concerns that countries such as Chile, Costa Rica, the 

Dominican Republic, Guatemala, and Indonesia require some U.S. exporters (e.g., of 

medical devices, pharmaceuticals, and cosmetics products) to “legalize” their 

documentation, oftentimes through the local embassy of the country of importation 

(which charges a fee), before filing applications for approval. This can add significant 

costs to the process of exporting. In addition, U.S. industry alleges that Peru requires 

documentation submitted to gain approvals for pharmaceuticals to be provided in a “Peru 

specific format” even when the information has been submitted to other countries and 

approved in the same format, leading to delays in approval of Peruvian applications. 

• Countries such as China and Korea require medical device producers to submit evidence 

of “prior approval” that the device offered for export has been approved in the country of 

manufacture or origin. This requirement adds costs and delays to the approval process.

In some cases, the product has been designed exclusively for export. In those cases, it is 

inappropriate to require the exporter to seek approval from its home country. 

• Brazil requires medical device producers to submit business proprietary economic data 

(e.g., prices in other markets, distributor mark-ups, advertising/promotion budgets) as a 

condition for registering or re-registering their products, even though such data may not 

exist or is unrelated to medical device safety or efficacy. In the process of purportedly 

clarifying Brazil’s procedures for registering medical devices, Brazil’s regulator posted 
55

business proprietary economic data on its web site, contrary to assurances it had 

provided to U.S. industry that it would not do so.

The U.S. government works to resolve these issues as they arise in individual cases through the 

TBT Committee and bilateral engagement. The United States also looks for opportunities to try 

and resolve these issues, or prevent their emergence, on a systemic basis. APEC is conducting

work to promote streamlining of export certificate requirements for agricultural products

consistent with Codex guidelines on official certificates for import and export. The TPP 

negotiations may present another such opportunity for the United States to make progress on 

this issue.

The Rise of “Voluntary” Measures as Trade Barriers

In various product sectors, U.S. trading partners have adopted measures that are technically 

voluntary, but which are applied in a manner that makes compliance mandatory. As a result, 

these policies are not governed by the strong disciplines on mandatory product standards and 

conformity assessment procedures included in the TBT Agreement. One way countries have 

avoided their obligations is by developing voluntary standards through procedures that exclude 

foreign stakeholders (a practice that the TBT Agreement does not prohibit for developing 

voluntary standards) and then later turning these voluntary standards into requirements (where it 

is prohibited). Even if foreign stakeholders are provided the opportunity to comment when the 

government proposes to convert a voluntary standard into a technical requirement, it is often too 

late to shape the measure and avoid erecting a barrier to trade. For example: 

• Korea’s Energy Management Corporation (KEMCO) only certifies one type of thin 

film solar panel – the type that Korean producers manufacture – as meeting its version of 

the International Electrotechnical Commission standard. While compliance with that 

standard is not technically required for sale of solar panels in the Korean market, a 

company will not be commercially viable in Korea without KEMCO certification. As a 

result, U.S. solar panel producers that make different kinds of thin film panels find 

themselves locked out of the Korean market.

• The EU often issues voluntary standards (e.g., for lawnmowers and pressure vessels, 

among other products) and then later clarifies that there is a “presumption of 

compliance” with a mandatory requirement if these voluntary standard are followed. 

Because the EU’s voluntary standards are developed in a system where each EU 

Member State has a vote and U.S. companies without a European presence are excluded, 

this puts U.S. companies at a disadvantage because the standard often does not reflect 

their input.

• Japan issues voluntary guidelines for advanced safety features in automobiles. Although 

compliance with these guidelines is not technically mandatory, it is expected that 

industry will comply, and therefore the guidelines are de facto mandatory. However, 

Japan relies on the fact that the guidance is not formally binding to avoid complying with 

WTO notification and other notice and comment procedures. 

• The organic and halal standards that many governments have adopted are technically 

voluntary, but they often serve to preclude U.S. products from entering the market. For 
56

example, when Malaysia put in place a voluntary standard that did not allow for halal 

products to be manufactured on a dedicated line within a facility that also produces nonhalal products, many U.S. poultry and beef producers were effectively excluded from the 

Malaysian market. This is because Malaysia bans imports of non-halal poultry and beef 

products and it is often too costly for U.S. producers to set up separate production 

facilities for those products. 

As with the other issues identified in this section of the report, the United States works to 

resolve issues concerning voluntary standards through the TBT Committee and bilateral 

engagement as they arise in individual markets. The United States is also seeking to address 

these issues on a systemic basis as over 20 percent of the specific trade concerns that WTO 

Members raised in the TBT Committee in 2010 related to “standards.” Currently, U.S. officials 

are seeking opportunities to tackle the issue of voluntary standards in the NAMA and the TPP 

negotiations. The United States will also look to address this issue through the TBT Committee 

during the upcoming Sixth Triennial Review of the TBT Agreement. 
57

XI. Country Reports

Background on Trade Concerns Contained in the Country Reports

This section contains individual country reports detailing TBT barriers encountered by U.S.

stakeholders. The measures and practices the country reports identify raise significant trade 

concerns, and, in some instances, give rise to questions concerning whether a trading partner is 

complying with its obligations under trade agreements to which the United States is a party.40 

The decisions on which issues to include resulted from an interagency process that

incorporated the expertise of a variety of government agencies. 

While the tools used to address TBT barriers vary depending on the particular circumstances, in 

all instances, USTR’s goal remains the same: to work as vigorously and expeditiously as 

possible to resolve the issue in question. As reflected in the country reports, in many instances 

USTR seeks to resolve specific concerns through dialogue with the pertinent trading partner –

either bilaterally or through multilateral fora – and working collaboratively to obtain changes that 

result in improved market access for U.S. exporters.

The TBT Report provides more focused and structured reporting on country-specific standardsrelated issues compared to what appeared in prior NTE reports. Conversely, some prior NTE

reports may have included standards-related issues that USTR has not included in the TBT 

Report.

In response to USTR’s outreach in compiling this report, stakeholders raised a number of new 

standards-related concerns. In several cases, USTR lacked sufficient information about those 

concerns at the time of publication to include them in this report. For purposes of this report, 

USTR included measures and practices about which USTR is well informed; USTR continues, 

however, to gather information about others. Accordingly, the omission of any issue in this report 

should not be taken to mean that USTR will not pursue it, as appropriate, with the trading partners 

concerned, in the same manner as those listed below.

It is important to note that there are fewer country-specific trade issues set out in the 2011 TBT

Report than in the 2010 TBT Report because the 2010 TBT Report included some issues that the

United States successfully addressed last year, including several trade issues with China (cotton 

registration requirements, excessive packaging requirements, and Green Dam), Korea (WIPI 

requirement for cell phones, cosmetics approval process, and testing requirements for energy 

efficiency and lithium ion batteries); Brazil (quality and identity standards for distilled spirits), 

and Israel (auto parts labeling requirement). The United States also resolved issues involving 

conformity assessment procedures for children’s products in Brazil and Malaysia, and Ecuador’s 

conformity assessment procedures for industrial products. 

 

40 Nothing in this report should be construed as a legal determination that a measure included in the report falls 

within the scope of any particular WTO Agreement (e.g., whether the measure is subject to the TBT as opposed to 

the SPS Agreement).
58

Since the resolution of these issues was discussed in the 2010 TBT Report, they are no longer 

included in this section. However, the United States continues to monitor these issues closely to 

ensure that they do not re-emerge as problems for U.S. industry. Similarly, an analysis of the 

country sections of the 2011 TBT Report demonstrates that numerous other issues were recently 

resolved or are on a path to resolution. Despite these successes, U.S. exporters still face a 

variety of specific trade concerns as a result of measures adopted or proposed in the 17 countries 

and the EU as described in the pages that follow. 

Argentina

Bilateral Engagement

The United States raises TBT matters with Argentina both bilaterally and during meetings of the 

TBT Committee. 

Toys – Testing and Accreditation Requirements

On June 4, 2008, Argentina’s Ministry of Health (MoH) issued Resolution 583/2008, limiting the 

amount of phthalates that toys and other children’s articles may contain. While the 

regulation applies to all such products, it only calls for imported products to be tested for 

compliance. In addition, the resolution initially required imported toys and children’s articles to 

be accompanied by a technical report from the Argentina’s Center for Research and 

Technological Development for the Plastics Industry (INTI). Importers could not substitute 

technical reports from laboratories outside Argentina.

U.S. industry raised concerns regarding the resolution. In particular, U.S. industry expressed 

concern that there would be significant delays, costs, and burdens in exporting toys and children’s 

articles to Argentina based on INTI’s limited capacity to perform the required testing and the 

inability to test these products in the country of production. After the resolution was implemented, 

some U.S. stakeholders experienced significant delays in exporting toys to Argentina. One 

company reported that complying with the in-country test requirement added more than 90 days 

to the process of placing its products on the market.

The United States raised the matter with Argentina during TBT Committee meetings in 2009, 

and MoH subsequently revised its requirements. Revisions made in December 2009 and May 

2010 had the effect of allowing suppliers to export toys and children’s products to Argentina 

without a test report from INTI if the products were accompanied by: (1) a sworn statement 

affirming that the products meet Argentine product safety requirements; and (2) written proof 

issued by INTI that samples of the products had been received and were in the process of being 

analyzed. U.S. industry believed this procedure would reduce delays, but indicated that 

Argentina should consider additional revisions, such as recognizing laboratories outside of 

Argentina and expanding laboratory capacity in Argentina to ensure that producers could obtain 

test results in a prompt fashion. 

The United States continued to press Argentina on this issue at the April 2010 meeting of the 

U.S. – Argentina Bilateral Council on Trade and Investment. In response, MoH adopted 

Resolution 806/2010 in May 2010, which further revised its testing requirements. This 
59

resolution’s stated objective is “to expand the coverage of laboratories for phthalates testing by 

extending this responsibility to other competent and accordingly certified institutions.” The 

resolution provides for the Argentine Organization for Accreditation (OAA), an ILAC-MRA 

signatory body, to accredit foreign laboratories. While this resolution appears to be another 

positive development, OAA has yet to recognize any laboratories located outside of Argentina

to conduct the required testing, including bodies that are accredited by other ILAC-MRA 

signatories. Accordingly, the United States will continue to raise this issue with Argentina in 

2011.

 

Brazil

Bilateral Engagement

The United States and Brazil discuss TBT-related matters at various bilateral fora, including the 

Bilateral Consultative Mechanism (led by Brazil’s Ministry of External Relations and USTR), 

the Commercial Dialogue (led by Brazil’s Ministry of Development, Industry, and Commerce 

and the U.S. Department of Commerce), and the Economic Partnership Dialogue (led by Brazil’s 

Ministry of External Relations and the U.S. Department of State). The United States also 

discusses TBT matters with Brazil during TBT Committee meetings and bilaterally on the 

margins of these meetings.

Alcoholic Beverages – Labeling Requirements

In October 2009, Brazil notified the WTO of proposed revisions to its regulations 

governing the labeling of beverages and products of acetic fermentations. During meetings 

of the TBT Committee in June and November 2010, the United States raised concerns that 

some of the proposed revisions could potentially prohibit imports of specific U.S.–origin, 

internationally-traded spirits. Specifically, the United States expressed concerns with: (1) a 

prohibition on the use of abbreviations for common terms on labels; (2) a requirement that

product names be printed on the main label in bold face and upper case letters; (3) a requirement 

that a large decal be placed on the label including the importer’s registration number; and (4) a 

prohibition on the use of certain expressions on labels (such as “home-made”, “hand-crafted”, 

“reserve” and “special reserve”), even if these are associated with a company’s name or 

trademark. 

The United States also asked Brazil to clarify certain elements of its proposal, including: (1) 

whether the revised regulation would restrict the use of fanciful drawings and illustrations that 

are well-established elements of the trademark and clearly not intended to represent an 

ingredient of the spirit; (2) whether labels that display a drawing, figure, or illustration of any 

ingredient used to prepare the beverage must indicate all of the ingredients of animal or plant 

origin, regardless of quantity; and (3) the basis for requiring beverage cans to bear the statement

“This container must be washed prior to consumption.” 

During the November 2010 TBT Committee meeting, Brazilian officials indicated the revised 

regulation would not restrict the use of fanciful drawings and illustrations of type the United 

States referred to and that Brazil would allow the use of abbreviations for common terms. 

However, Brazil did not provide these clarifications in writing. Brazilian officials also noted 

that Brazil continues to review the proposed revision and will notify the WTO of any further 
60

changes. Thus far, U.S. industry has not reported any disruption of U.S. distilled spirits 

shipments to Brazil. The United States continues to monitor the situation closely.

Medical Devices – Inspection Requirements

Resolution 25, which Brazil notified to the WTO on May 18, 2009, requires ANVISA (Brazil’s 

medical device inspection agency) to inspect facilities that produce certain “high risk” medical 

devices to be sold in the Brazilian market by May 22, 2010. The United States does not contest 

Brazil’s right to inspect U.S. facilities; in fact, the U.S. Food and Drug Administration (FDA) 

maintains analogous authority to conduct inspections of Brazilian and other foreign facilities. 

However, the United States has been concerned that ANVISA would not have sufficient resources 

to inspect all overseas facilities that ship these devices to the Brazilian market by the May 22, 

2010 deadline, potentially disrupting hundreds of millions of dollars in U.S. exports and 

jeopardizing the adequate supply of essential medical devices to the Brazilian market.

In late 2009 and early 2010, the U.S. government and U.S. industry representatives engaged with 

ANVISA in an attempt to clarify the inspection requirements and seek assurances from Brazil that 

trade in medical devices would not be disrupted after the deadline if ANVISA could not complete 

all of the inspections (and related registrations) in time. In response, Brazil clarified that class I 

medical devices (e.g., tongue depressors, bedpans) and class II devices (e.g., powered wheelchairs, 

surgical drapes) would be exempted from the inspection requirement, and that ANVISA’s 

inspections would apply only to the last place of manufacture (as opposed to all the supplier 

facilities). Additionally, Brazil indicated that only plants manufacturing devices subject to reregistrations or new registrations would need to be inspected by May 22, 2010; other products 

could remain on the Brazilian market after the deadline pending an inspection. 

Despite this progress, problems remain. In October 2010, ANVISA issued Technical Note No. 

001/2010/GGTPS/ANVISA (Requirement of Good Manufacturing Practices and Control 

Certificate), which will require GMP inspections and registration processes to be conducted 

consecutively for products filed with ANVISA after the deadline instead of allowing these 

processes to occur simultaneously. U.S. industry is concerned that this change will delay entry of 

new medical devices by over a year given the number of inspections already pending with 

ANVISA. The United States will continue to monitor the situation closely in 2011 to ensure 

that U.S. exports are not disrupted. 

Medical Devices – Data Requirements for Registration

Resolution 185 of 2001, which sets out ANVISA’s registration requirements for medical devices, 

requires manufacturers to submit detailed economic data, including confidential and 

proprietary information. The data requirement does not appear to fulfill a legitimate 

objective related to evaluating medical device safety or efficacy. As explained in last year’s TBT 

Report, ANVISA in 2009 published a resolution clarifying the registration requirements, 

which was welcomed by U.S. and industry officials. Around the same time, Brazil also 

committed to U.S. industry that it would not publish any confidential or proprietary information.

On September 14, 2010, ANVISA unexpectedly published company-specific pricing data that 

individual U.S. producers had supplied. The United States raised concerns regarding 

ANVISA’s action with Brazilian officials on the margins of the TBT Committee meeting in 
61

November 2010. The United States continues to urge ANVISA to remove the proprietary data 

from its website. At the same time, the United States is working with U.S. industry to develop a 

methodology for displaying the data where needed while also protecting the confidentiality of 

information manufacturers provide in the registration process. 

Telecommunications – Acceptance of Test Results

Brazil’s National Telecommunications Regulatory Agency (ANATEL) does not accept test data 

generated outside Brazil, except in cases where the equipment is too physically large or costly to 

transport. Accordingly, U.S. suppliers must submit virtually all of their information technology 

and telecommunications equipment for testing to laboratories located in Brazil before it can be 

placed on the Brazilian market. This requirement results in redundant testing to be conducted, 

and consequently, both higher costs and delayed time to market in Brazil.

During 2010, the United States continued to urge Brazil to implement the CITEL (InterAmerican Telecommunication Commission) MRA. Brazil has not agreed to do so, and the 

United States will continue to advocate for this position in 2011. If Brazil implemented the 

CITEL MRA it would benefit Brazilian suppliers seeking to sell into the U.S. market by 

enabling them to use test results from laboratories located in Brazil to certify that their 

telecommunications products meet FCC requirements.

Toys and Children’s Articles – Conformity Assessment Procedures

In past years, U.S. industry raised concerns about a measure that Brazil’s National Institute of 

Metrology, Standardization, and Industrial Quality (INMETRO) proposed to amend Brazil’s 

existing conformity assessment procedures for toys and children’s articles. The measure would

have permitted foreign manufacturers to test their toys for compliance with Brazilian toy safety 

requirements in the country of manufacture. However, this proposal would have required

imported toys already tested abroad to undergo a second round of testing in Brazil, while only 

requiring domestically-produced toys to be tested once. In addition, the industry was concerned

about Brazil’s proposed procedures for placing INMETRO conformity assessment seals on 

conforming products in Brazil. In particular, U.S. producers requested to use either the System 

5 (“Compliance Imprint Certification Model”) or System 7 (“Lot Certification Model”) conformity 

assessment procedures for their products, similar to Brazilian producers.

During meetings of the TBT Committee in 2009, the United States, joined by the EU, Thailand, 

and China, noted that it strongly shares Brazil’s objective of protecting children from exposure to 

potentially dangerous substances in toys and other children’s articles, but questioned the basis for 

Brazil’s requirement that imported toys would be subject to two sets of tests, while domestic toys 

would only be subject to one. As noted in last year’s report, in September 2009 INMETRO 

announced several improvements to its conformity assessment procedures to address some 

of the concerns that were raised. Most notably, these improvements proposed to: (1) 

eliminate the second test requirement on imports; (2) allow laboratories accredited by an 

ILAC MRA signatory to conduct the testing in certain circumstances; (3) provide foreign 

producers with the option of importing under System 5 or System 7; and (4) permit foreign 

producers using System 5 to add the INMTERO conformity assessment seal at the place of 

manufacture instead of in Brazil. In early November 2009, INMETRO published a revised 

measure incorporating these improvements and notified it to the WTO. Brazil indicated that the 
62

measure would take effect on May 22, 2010. The United States welcomed the new measure. 

In early May 2010, the United States posed additional questions about how the new system 

would operate in practice to ensure that it would not create unnecessary export barriers for U.S. 

industry. INMETRO replied to these questions and extended the implementation period an 

additional 5 months to October 29, 2010. The United States has not received any reports of export 

issues arising from Brazil’s implementation of the new measure, but will continue to monitor the 

situation.

Products of Animal Origin – Labeling Registration Requirement

In August and September 2010, Brazil notified the WTO of proposed changes to its labeling 

registration form for products of animal origin. Brazil’s new registration form requires the 

health or veterinary authority of the exporting country to certify that an exporter’s establishment 

is “in compliance” with Brazilian standards and legislation. The United States does not consider 

it appropriate for governments to condition access to their markets for animal products on a 

certification of this nature. Further, Brazil’s requirement causes particular concerns for U.S. 

industry because U.S. health and veterinary authorities are not authorized under federal law to 

attest that a U.S. production facility complies with a foreign country’s market standards or 

legislation.

In September 2010, the U.S. government and U.S. industry submitted comments to Brazil 

regarding the proposed measure, and U.S. officials raised the issue with Brazil during the 

November 2010 TBT Committee meeting. Brazil provided a response to U.S. comments, which 

U.S. officials are reviewing. The United States will continue to monitor this issue and ensure 

that Brazil’s measure does not disrupt trade in products of animal origin.

Wine – Certification

In December 2009, Brazil notified the WTO that it had eliminated its requirement for wineries to 

register the Brazilian government, a step that will reduce costs for U.S. exporters. At the same 

time, Brazil instituted a new certificate of origin and product analysis requirement for imported 

wine products, which would raise costs. During 2010, U.S. industry informed the U.S. Alcohol 

and Tobacco Tax and Trade Bureau (TTB) that Brazilian Customs had held up several U.S. 

wine shipments on the ground that the shipments did not comply with this new requirement. 

The United States raised concerns with Brazil about this issue at the TBT Committee meetings 

throughout 2010. At these meetings, the United States pointed out that this new requirement is 

unnecessary and duplicative since the TTB already issues certificates of analysis, origin, free 

sale, and typicity for U.S. wines. The United States is continuing to work to resolve this issue 

and to ensure that U.S. wine exports do not face any additional market access restrictions in 

Brazil. 

Beverage Registration

In December 2009, Brazil notified the WTO of a proposed measure that would require the 

government of each exporting country to provide a list of approved production facilities for nonalcoholic beverages, distilled spirits, and malt beverages as well as a list of laboratories that 
63

would test these products to ensure they met Brazil’s requirements for import. On September 

14, 2010, the United States submitted comments to Brazil on its proposed measure, indicating

that it would be impossible for the U.S. government to comply with Brazil’s proposed 

requirement for non-alcoholic beverages because the United States does not accredit 

organizations and laboratories for the testing or export of non-alcoholic beverages.

These new requirements, which took effect September 28, 2010, have already adversely affected 

U.S. exports. Brazilian customs officials detained at least four shipments of U.S.-produced 

vegetable juices and sauces in late 2010. While U.S. officials at the U.S. Agricultural Trade 

Office in Brasilia were able to secure the release of these products, these actions do not provide 

a basis for a viable long-term solution to the problem. 

In an effort to secure a more permanent solution, the United States raised concerns regarding 

this issue with Brazil bilaterally in November 2010. In particular, the United States asked Brazil 

to indicate how it will allow imports from countries that do not maintain a list of governmentapproved laboratories and to explain whether it maintains a similar list for domestic companies. 

In response to U.S. concerns, Brazil requested the United States to propose an alternate 

certification procedure. The United States continues to press Brazil for specific responses to the 

U.S. questions while discussing potential practical ways forward with U.S. industry.

China

Bilateral Engagement

The United States and China regularly engage on TBT-related issues through the U.S.-China 

Joint Commission on Commerce and Trade (JCCT) and bilaterally on a case-by-case basis as

specific market access issues arise. The JCCT, which was established in 1983, is the main 

forum for addressing bilateral trade matters and promoting commercial opportunities between the 

United States and China. The JCCT has played a key role in helping to resolve bilateral TBT 

issues, including those related to medical device recalls and registration, certification of IT 

products, and cotton registration requirements. 

At the October 2009 JCCT meeting, the United States and China agreed to convene a publicprivate meeting on standards and conformity assessment procedures to increase collaboration on 

standards and conformity issues. This meeting was subsequently held in the first quarter of 

2010. The JCCT has also played a key role in helping to resolve bilateral TBT issues, including 

those related to medical device recalls, registration and certification requirements for

information technology (IT) products, and cotton registration requirements. Also, as agreed 

during the 2009 JCCT meeting, the U.S. Department of Commerce, together with the 

Standardization Administration of China (SAC), co-hosted a standards roundtable on energy 

efficiency and new energy on September 29, 2010 in Beijing. 

USTR is continuing to monitor closely China’s development and use of standards and technical 

regulations in the IT sector, as discussed in more detail at pages 50-51 of the 2010 TBT Report.

China Compulsory Certification (CCC) Requirements – Conformity Assessment Procedures

Since 2003, China has required the China Compulsory Certification (CCC) mark to be applied 
64

to Chinese and foreign goods covering more than 159 product categories – including electrical 

machinery, IT equipment, household appliances, and their components. U.S. industry has raised

concerns about multiple aspects of these requirements, including that they are particularly 

burdensome for SMEs because any applications for CCC mark exemptions must be submitted in 

China’s Certification Accreditation Administration (CNCA) Beijing offices. The United States 

has also had longstanding concerns that China does not permit U.S. suppliers to use competent 

conformity assessment bodies (e.g., testing laboratories, inspection bodies, and product 

certifiers) located outside China’s territory to demonstrate that their products comply with CCC 

mark requirements. To date, CNCA has not accredited any U.S. conformity assessment body to 

test and certify products and inspect facilities for purposes of the CCC mark. 

China’s failure to accredit laboratories for testing, and to test or certify products for purposes of 

the CCC mark adversely impacts U.S. exports to China as at least 20 percent of U.S. exports to 

China must obtain the CCC mark prior to market entry. Because China will not accept testing 

and certification performed by U.S. conformity assessment bodies, U.S. exporters must submit 

their products to Chinese laboratories for tests that have already been performed abroad, resulting 

in greater expense and delayed access to China’s market. In addition, because there is typically 

only one designated certification body in China authorized to perform testing, inspection, and 

certification for any given product, U.S. suppliers regularly report delays in marketing their 

products. Further, since Chinese conformity assessment bodies do not generally have a presence 

outside of China, U.S. companies exporting to China must: (1) arrange and fund travel by a 

Chinese inspection agent to perform pre-market inspections at the manufacturer’s location in the 

United States; (2) submit to subsequent annual inspections after receiving authority to apply the 

CCC mark to their products; and (3) pay for their products to be tested and certified in China. 

U.S. industry also asserts that China’s conformity assessment bodies often change their criteria

without providing advance notice and an opportunity to comment. 

In 2010, the United States continued to emphasize concerns to China regarding its CCC mark 

requirements. The United States, in collaboration with U.S. industry, organized a pair of 

cooperative roundtables with CNCA in 2010 to increase awareness and appreciation in China of 

U.S industry concerns regarding virtually every stage of China’s complex and multifaceted CCC 

program, including: (1) transparency, procedural, and cost concerns associated with submitting 

U.S. manufacturing facilities to pre-market inspections by Chinese inspection agents; (2) issues 

related to shipping and arranging to have a product tested and certified in China; (3) additional 

requirements for type-approval requirements and provincial post-market inspections; and (4) the 

requirement of subsequent factory inspections to retain use of the CCC mark. The roundtables 

also provided opportunities for U.S. participants to glean additional information concerning how 

the CCC program operates, which will help support and inform the broader U.S. approach to 

addressing systemic trade concerns related to China’s conformity assessment procedures.

In 2011, the United States will continue to work with China to find practical solutions to the 

concerns about CCC compliance issues. Among other suggestions, the United States will urge 

China to take positive, trade-facilitating steps to liberalize its approach to recognizing competent 

foreign conformity assessment bodies, such as by recognizing laboratories that have been 

accredited under an ILAC MRA or by IAF MLA signatories.

IT Products – Mandatory Testing and Certification
65

In August 2007, China notified to the WTO a series of thirteen proposed measures requiring 

certain IT products to be certified for information security functions. The proposed measures 

appeared to require testing and certification to certain Chinese national standards for information 

security which, in some areas, may differ from international standards used in the global market.

In some cases, the Chinese standards require access to algorithms held by Chinese regulators, 

and it is unclear on what basis those algorithms will be made available. China’s General 

Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) indicated that the 

thirteen proposed measures would be mandatory for all covered products as of May 1, 2009.

The United States and other WTO Members expressed serious concerns to China about these 

proposed measures in numerous bilateral and multilateral meetings, and China eventually

confirmed that the compulsory certification requirement will apply only when products are sold 

to government agencies, and not to state-owned enterprises or in other sectors of China’s 

economy. This concession represented a significant reduction in the scope of the requirements 

from China’s original plan. In October 2009, China also agreed to a dialogue with the United 

States regarding global best practices for trade in information security products.

In 2010, the United States continued to monitor potential Chinese activities in the information

security sphere. When it became apparent that China’s State Encryption Management Bureau 

was planning to revise its 1999 Regulations on Commercial Encryption Codes, the United States 

raised concerns in the TBT Committee, noting that should China’s planned revision of these 

regulations expand their scope to more IT products, the impact of the encryption regulations 

would be felt across a broader swath of the global IT sector. U.S. officials also noted that such 

an expansion could create the sort of trade disruption that China’s initial version of the 

encryption regulations engendered they were issued in 1999. Several months after releasing the 

initial version, China reduced the scope of the regulations to products whose core function is 

encryption. USTR will continue to monitor closely any developments in this area in 2011. 

Medical Devices – Conformity Assessment Procedures

The United States has expressed concerns that China maintains two separate authorities — the 

State Food and Drug Administration (SFDA) and AQSIQ — to enforce regulations with similar, 

but not identical, requirements for selected medical devices. The potential overlapping and 

unclear delineation of responsibilities can result in additional and unnecessary regulatory 

procedures with no demonstrable public health benefit. For example, Decree 95, issued by 

AQSIQ in June 2007, would have imposed an onerous examination and supervision regime on 

imported medical devices, introducing additional testing and inspection redundancy to the 

certification schemes administered by SFDA and, in some cases, CNCA.

The United States, working closely with U.S. industry, has raised these concerns with China on 

multiple occasions, including at the JCCT. In November 2007, AQSIQ issued a notice 

suspending implementation of Decree 95. In a further step to streamline the registration 

process, in September 2008 SFDA and AQSIQ jointly announced that they would require only 

one test, one report, one fee, and one factory inspection for medical devices. Industry welcomed 

this commitment, projecting that by reducing redundancies this step could cut medical device 

approval times in half, which would provide U.S. industry with more timely access to China’s 

medical device market.
66

In April 2009, SFDA circulated for public comment a draft measure intended to supersede the 

Administrative Measures on Medical Device Registration, originally issued in 2004, but did not 

notify the draft measure to the WTO. The United States subsequently expressed concerns about 

this draft measure in bilateral discussions with SFDA during the October 2009 JCCT meeting,

and before the TBT Committee as part of China’s Transitional Review Mechanism (TRM). Of 

particular concern was a proposal to require all medical devices to be registered in the country of 

export or the manufacturer’s legal residence before they could be accepted for registration in 

China.

This requirement had the potential to block, or inordinately delay, sales of safe, high-quality 

medical devices to the Chinese market because manufacturers may decide not to seek to have 

their devices approved in the countries in which they are produced or in the producers’ home 

countries for reasons unconnected with the quality or safety of their products. For example, 

producers may design particular medical devices specifically for patients in a third country, such 

as China, or may choose to produce them in a third country for export only. In these situations, 

a manufacturer would have no business reason to seek to have a particular device approved in its 

home country or the country of export and would likely forego that process in order to avoid the 

associated burdens of time and money.

Also in April 2009, AQSIQ circulated draft Regulations on the Recall of Defective Products, 

which would apply to medical devices. Given that China’s Ministry of Health and SFDA had 

begun a process in 2008 to develop a recall system that would also cover medical devices, the 

United States became concerned about the possibility of redundant recall procedures. The United 

States raised its concerns in bilateral JCCT-related discussions, as well as during the WTO’s 

China TRM process.

During the October 2009 JCCT meeting, China indicated that it would not require a medical 

device to be registered in the country of export or in the country of legal residence of the 

manufacturer as part of its prior approval process for medical devices. However, draft 

measures of the State Council on Supervision and Administration of Medical Devices issued 

in 2010 maintained the country of export registration requirement. In bilateral discussions 

with China during 2010, the United States continued to urge China to exclude the 

registration from its final measures. The United States will continue to press this issue 

during 2011. 

In addition, China’s continued failure to permit U.S. suppliers to use competent conformity 

assessment bodies (e.g., testing laboratories, inspection bodies, or product certifiers) located 

outside China to demonstrate that their products comply with Chinese requirements negatively 

affects U.S. exports of medical devices to China. Since China will not accept testing and 

certification that the U.S. manufacturer or a U.S. conformity assessment body has conducted, 

U.S. medical device exporters must submit their products to Chinese laboratories for tests that 

have already been performed in the United States, resulting in greater expense and a longer time 

to market.
67

During the October 2009 JCCT meeting, China indicated that it would consider exempting 

medical devices from being tested in Chinese laboratories where manufacturers can demonstrate 

that their devices comply with relevant international standards. Based on information the U.S. 

government has received from industry stakeholders to date, however, it appears that China has 

not yet taken action to exempt such products from testing in Chinese laboratories. The United 

States will continue to press China on this issue in 2011. 

Mobile Phones – WAPI Standard

In 2003, China issued two standards for encryption over wireless local area networks 

(WLANs), applicable to domestic and imported equipment containing WLAN technologies. 

Conformance to these standards was scheduled to become mandatory in 2004. The standards 

incorporated the WAPI encryption algorithm for secure communications. China sought to 

enforce the use of WAPI by mandating a particular algorithm (rather than mandating the need for 

encryption, and leaving the choice of the algorithm to market factors) and providing the 

necessary algorithm only to a limited number of Chinese companies. Had the standards become 

mandatory, U.S. and other foreign manufacturers would have been compelled to work with and 

through these companies, some of which were competitors, and provide them with their 

proprietary technical product specifications. Following high-level bilateral engagement, China

agreed in April 2004 to postpone indefinitely implementing WAPI and to work within 

international standards processes in developing future wireless standards. This commitment 

led China to submit WAPI for consideration in ISO and IEC’s Joint Technical Committee 1 

(JTC1). In a 2006 ballot of ISO/IEC JTC1 members, the proposed WAPI amendment did not 

secure enough votes to be accepted as an ISO/IEC standard.

Concerns regarding WAPI re-emerged in 2009 as China moved forward with plans to 

require the WAPI standard to be used in mobile handsets, despite the growing commercial 

success of computer products in China that comply with the internationally recognized WiFi 

standard developed by the Institute of Electrical and Electronics Engineers (IEEE). Moreover, over

the past several years, global mobile handset makers have increasingly added WLAN/Internet 

capability to their products consistent with the WiFi standard, thus expanding the use of WLAN 

equipment beyond laptops and home computers to mobile handsets. However, until recently (as 

noted below) China had not issued type approvals for handsets that connect to the Internet 

through WLAN equipment, and instead had only issued type approvals for handsets that connect 

to the Internet through cellular networks, a practice that has required foreign equipment makers to 

disable WLAN/Internet capability before their handsets could be marketed in China.

In 2009, as part of its plan for encouraging an aggressive roll-out of third generation (3G) mobile 

handsets by Chinese telecommunications operators, many of which employ Internet-enabled via 

WLAN networks, China established a process for approving hand-held wireless devices such as 

Internet-enabled cell phones and smart phones. During bilateral talks in 2009, China indicated 

to U.S. government officials that it would approve devices that use the WiFi standard, but only if 

those devices are also enabled with the WAPI standard. Chinese officials acknowledged that there 

is no published or written measure setting out this requirement and that China has not notified this 

requirement to the WTO. In 2010, the United States continued to urge China to publish the 

measure in draft form, notify it to the WTO, allow a meaningful time for comments, and take 

the comments into account in developing any final measure. 
68

Patents Used in Chinese National Standards

In recent years, concerns have arisen regarding China’s proposed treatment of patented technology 

in connection with domestic standards development processes. First, in late 2004, concerns arose 

after the Standardization Commission of China (SAC) issued draft Provisional Regulations for 

National Standards Relating to Patents (Provisional Regulations) and key Chinese government 

officials made public statements that appeared to contemplate compulsory licensing of patented 

technologies used as national standards in China. 

In November 2009, SAC circulated a new draft of the Provisional Regulations for public 

comment. This draft measure would implement China’s vision for a standards development 

process and establish the general principle that mandatory national standards should not 

incorporate patented technologies. However, when mandatory national standards incorporate 

patented technologies, the draft measure provides for the possibility of a compulsory license if a 

patent holder does not grant a royalty-free license. This differs from the typical practice of 

accredited standards developing organizations in other countries, which require disclosure of 

intellectual property in the standards development process and support “reasonable and 

nondiscriminatory” (RAND) licensing policies with respect to intellectual property that is 

incorporated into a standard. RAND policies require concerned patent right holders to make any 

intellectual property incorporated into the standards that these bodies develop available to all 

interested parties on RAND terms. Within the standards development process, licensing 

terms are typically negotiated between the right holder and parties interested in implementing the 

standards.

Second, in 2006, the Chinese government’s Electronic Standardization Institute (CESI), a 

Chinese government entity, released draft intellectual property policy rules for standards-setting 

organizations (SSOs). These draft rules envisage Chinese government involvement in standardsetting processes, including a requirement that SSOs obtain government approval for patent 

claims. Such government involvement could be exercised in a way that affects private party 

transactions and could raise concerns under certain circumstances.

In January 2010, the China National Institute of Standardization (CNIS) solicited public 

comments on its notice titled “Disposal Rules for the Inclusion of Patents in National 

Standards.” The “Disposal Rules” are the supporting documents for SAC’s Provisional 

Regulations. In October 2010, CNIS finished the second draft of the Provisional Regulations, 

“Special Procedure on Standards Making—Inclusion of Patents in National Standards,” and 

submitted them to SAC for review.

U.S. companies have expressed serious concerns regarding these proposals. The United States 

will continue to monitor how China treats intellectual property through its SSOs, including the 

development and finalization of CESI’s rules, as well as the development of SAC’s revised 

Provisional Regulations. In addition, the United States will discuss these issues with China in 

the JCCT Intellectual Property Rights (IPR) Working Group, where both sides have agreed to 

discuss related issues with participants from all relevant Chinese and U.S. agencies. 
69

Colombia

Bilateral Engagement

The United States discusses TBT matters with Colombia during TBT Committee meetings and on 

the margins of these meetings. 

Distilled Spirits – Quality, Identity and Labeling Requirements

The 2010 TBT Report and Section IX of this report outline U.S. industry concerns about quality 

and identity requirements that Colombia proposed in 2009 for distilled spirits, including gin, rum, 

vodka, and whiskey. The U.S. government and U.S. industry raised this issue with Colombia at 

TBT Committee meetings, and Colombia responded by clarifying and adjusting its measure to 

address many of the concerns that were raised. For example, Colombia abandoned its proposal to 

require quality certificates for distilled spirits and removed a proposal to hold all parties in the 

production responsible for maintaining sanitary conditions for these products.

Although Colombia made positive modifications to its requirements, the United States continues 

to be concerned about certain proposed requirements that have not been withdrawn. For example,

Colombia has not withdrawn a proposal to use analytical parameters related to the chemical 

composition of spirits, such as a limit on congeners and other naturally occurring constituents 

included in gin, vodka, and rum. This policy could bar some U.S. spirits from the Colombian 

market and it is inconsistent with the standards of identity for distilled spirits sold in the United 

States, the European Union, Canada, and nearly every other major spirits market. Unlike 

Colombia’s proposal, these markets base their standards of identity on the raw materials used 

to produce distilled spirits, not on their chemical composition. Naturally occurring constituents

produced in the fermentation and distillation process, such as congeners, esters, and aldehydes, 

among others, are integral to the distinctive flavor characteristics of the various brands and 

categories of distilled spirits, and there is no scientific evidence to suggest that the presence of 

these constituents is the concentrations found in distilled spirits is harmful to consumers. In 

addition, Colombia’s proposal to impose minimum and maximum alcohol content limits on 

distilled spirits could also adversely affect U.S. exports. For this reason, the United States has 

expressed significant concerns with Colombia both bilaterally in meetings of the TBT 

Committee.

The European Union

Bilateral Engagement

The United States has actively engaged the European Union (EU) on TBT-related matters in 

multilateral fora, including the TBT Committee, as well as bilaterally. The United States has also 

used the Transatlantic Economic Council (TEC) and the United States – European Union HighLevel Regulatory Cooperation Forum (HLRCF) as forums to raise concerns and encourage 

systemic changes in the EU approach to key TBT issues. 

In addition to raising concerns with the EU regarding standards-related measures as they arise, the 

United States and the EU have also used these fora to coordinate their regulatory approaches, which 

the two sides recognized in the TEC could result in greater compatibility of effective and 
70

economically beneficial regulation and promote economic integration. Further, the United States 

and the EU have jointly advocated to trade and regulatory officials in key emerging markets 

such as Brazil, China, and India the importance of maintaining open and transparent regulatory 

and standards development processes, as well as jointly advocating on specific market access 

issues on behalf of U.S. and EU exporters.

Accreditation Rules

The United States continues to have serious concerns regarding the EU’s accreditation framework 

set out in Regulation (EC) No 765/2008. The regulation, which applies to all sectors, became 

effective on January 1, 2010. It requires each Member State to appoint a single national 

accreditation body and prohibits competition among Member States’ national accreditation 

bodies. The regulation further specifies that national accreditation bodies shall operate as 

public, not-for-profit entities. This means that only a single, government entity in each 

Member State shall be permitted to accredit conformity assessment bodies in the EU.

The EU regulation raises serious questions as to whether the EU or its Member States will 

continue to recognize non-EU accreditation bodies that have been accredited under the 

ILAC MRA and the IAF MLA and will continue to accept conformity assessments performed 

by such bodies. Because the regulation gives Member States discretion regarding whether to 

recognize non-European accreditation bodies and whether to accept conformity assessments 

issued by ILAC MRA and IAF MLA accredited bodies, it is possible that Member States may 

refuse to recognize non-European accreditation bodies and refuse to accept conformity 

assessments issued by these bodies. The regulation raises market access concerns for U.S. 

producers, whose products may have been tested and/or certified by conformity assessment 

bodies accredited by non-European accreditation bodies. 

The EU’s approach to foreign accreditation bodies is undermined by the view of the 

European co-operation for Accreditation (EA). The EA has acknowledged that attestations of 

conformity assessment results issued by bodies that have been accredited by non-European bodies 

that are ILAC MRA or IAF MLA signatories are as reliable as those issued by European bodies 

complying with the new accreditation requirements set forth in Regulation 765. 

The United States has raised its concerns over Regulation 765 with the EU in the TBT 

Committee. In response, the EU has stated that the regulation does not apply outside of the EU, 

and thus, will not affect U.S. accreditors or the international conformity assessment system. 

However, these assurances appear to conflict with the measure’s provisions, which do not limit 

its application in that way.

The United States is also concerned with an apparent lack of technical basis for the assumptions 

behind the regulation, including that: (1) accreditation activities should be limited to 

governmental bodies or bodies that act in the exercise of official authority; (2) accreditations 

should be viewed with a higher degree of confidence when provided by a single national 

accreditation body; and (3) competition could compromise the quality of accreditations and 

should therefore be limited. In fact, the United States holds the opposite views, and the EU has 

failed to give an adequate explanation of the basis for its assumptions. 
71

Similarly, the EU has not explained why the regulation imposes conditions on accreditors 

operating in the EU market that extend beyond the relevant ISO/IEC standard applied under the 

ILAC MRA and the IAF MLA. 

From a broader standpoint, the United States is concerned about the implications of the EU’s 

system for the international accreditation system under the ILAC MRA and the IAF MLA. 

In particular, the United States is concerned that the EU may be seeking to undermine this 

system by encouraging governments to adopt the EU approach. If governments do so, there 

could be a substantial adverse effect on U.S. exports, and the United States may be required 

to alter the manner in which U.S. goods are certified to meet product standards in export 

markets. 

Thus far, the EU’s ILAC signatories appear to be cooperating with non-EU ILAC signatories

and confirming the equivalence of their respective accreditations if applicable requirements have 

been met. However, the United States continues to be concerned about the Regulation’s 

potential impact on the recognition of non-EU accreditation bodies under the ILAC MRA and 

the IAF MLA and the acceptance of conformity assessments performed by ILAC MRA and IAF 

MLA accredited bodies. As a result, the United States is continuing to urge the EU to revisit its 

approach to accreditation. In the short term, the United States is also encouraging the EU to issue 

guidance to Member States indicating that accreditations by ILAC MRA and IAF MLA 

signatories are no less reliable than accreditations by European national bodies, which would 

allow Member States to accept testing and certification from non-EU bodies that have been 

accredited by an ILAC MRA or IAF MLA signatory. 

Borates and Nickel Compounds – Classification and Labeling Requirements

Since 2007, the EU proposed changing the classification and labeling requirements for 896 

substances, including borates, nickel carbonates and other nickel compounds. Under the 

EU’s previous regime, the Dangerous Substances Directive (DSD), the EU proposed 

classifying these compounds under Category 2, which would have included product and 

packaging restrictions. For instance, Category 2 would have required products containing 

borates above a certain concentration to carry a “skull and crossbones” label, thus 

discouraging manufacturers from using borates. 

In December 2008, the EU decided to replace the DSD with a new regime for classification 

and labeling, the Regulation on the Classification, Labelling and Packaging of Substances and 

Mixtures (CLP). Under the CLP, the EU would continue to classify borates and other nickel 

compounds in a stringent category known as Category 1B, which would subject them to product 

and packaging restrictions, including a requirement to use labels showing a picture of an 

“exploding man,” along with warning and risk phrases. 

The U.S. industry believes that the classification of borates under this new category is 

unnecessarily trade-restrictive, and is not based on “normal handling and use” of downstream 

products containing borates. Industry raised further concerns that the classification of borates in 

this manner would lead to restrictions and bans on using borates in certain products (e.g., 

cosmetics, detergents, and fertilizers) under related EU directives. 

Various industrial producers have launched cases in the UK courts and in the European Court of 
72

First Instance seeking to annul the borates and nickel classifications. In addition, the United 

States has frequently raised questions regarding these issues in the TBT Committee. In particular, 

the United States continues to be concerned with the EU’s procedures for classifying borates 

and certain nickel compounds, specifically regarding possible flaws in the EU’s classification 

methodology, the procedures the EU used in transferring these classifications from the DSD to 

the CLP, and the effect these classifications will have under other EU measures, such as the EU’s 

chemical regulation, REACH. In 2011, the United States will continue to monitor the potential 

adverse trade effects of the EU’s nickel and borates classifications as well as the methodological 

issues mentioned above.

Chemicals – REACH Regulation

The 2010 TBT Report recounts substantial U.S. concerns with the EU’s chemical regulation, 

REACH. REACH impacts virtually every industrial sector, from automobiles to textiles, 

because it regulates chemicals as a substance, in preparations, and in products. It imposes 

extensive registration, testing and data requirements on tens of thousands of chemicals. REACH 

also subjects certain chemicals to an authorization process that would prohibit them from being 

placed on the EU market except as authorized for specific uses by the European Commission. 

U.S. industry has expressed specific concerns with the fact that REACH requires polymer 

manufacturers and importers to register reacted monomers in many circumstances. This is 

problematic because reacted monomers no longer exist as individual substances in polymers and 

would not create exposure concerns in the EU. In addition, EU polymer manufacturers 

generally can rely on the registrations of their monomer suppliers and do not need to be 

individually registered. As a result, the reacted monomer registration requirement provides an 

incentive for distributors to stop importing polymers and switch to EU polymer suppliers. The 

United States has pressed the EU to eliminate the requirement to register reacted monomers in 

polymers entering the EU market.

Moreover, REACH contains notification and communication obligations with respect to 

substances on the Candidate List, a list of substances that may become subject to authorization. 

Differing interpretations between the Commission and several Member States regarding when these 

obligations apply has created uncertainty about how to comply with these obligations. The 

Commission has indicated that notification and communication obligations apply if a substance 

on the List is present in an article in concentrations above 0.1 percent of the article’s entire weight; 

however, these Member States have stated that these obligations should apply when a substance on 

the List is present in concentrations above 0.1 percent of the weight of the article’s components or 

homogenous parts. In 2010, these Member States pushed the Commission to reverse its position as 

a way of protecting the EU market from imports since a reinterpretation would impact imports. A 

change in interpretation would present a much more difficult compliance problem for U.S. industry

since it would require companies to perform an analysis of individual component concentration 

levels in their products, which would be extremely time-consuming and burdensome. Given that an 

alteration of the EU’s approach could substantially disrupt U.S. exports, the United States has 

asked the EU to ensure that all Member States follow the Commission’s current interpretation. 

Other problematic issues with the EU’s REACH regime include inadequate transparency, 

differing registration requirements for EU and non-EU entities, and substantial data 

requirements. 
73

The United States has raised concerns regarding REACH at every TBT Committee meeting since 

2003, and has been joined by many other delegations, including Argentina, Australia, Brazil, 

Canada, Chile, China, Colombia, Cuba, the Dominican Republic, Ecuador, Egypt, El Salvador, 

India, Israel, Japan, Korea, Malaysia, Mexico, Qatar, Russia, Singapore, Switzerland, Taiwan, and 

Thailand. The United States also has raised its concerns regarding REACH directly with the EU

and has worked with the European Chemicals Agency on specific technical issues. The United 

States will continue to monitor closely REACH implementation in 2011, and will raise trade 

concerns, as appropriate, in the TBT Committee and other pertinent fora. A potential new venue 

for pursuing these concerns is the U.S. – EU Chemicals Dialogue agreed to at the December

2010 TEC meeting. 

Industrial Products – Country of Origin Labeling for Imports Only

The EU is considering adopting country of origin labeling requirements for leather, travel goods, 

hand bags, apparel, textiles and textile articles, ceramics, glassware, jewelry, furniture, bedding, 

lamps and lighting, brooms and brushes, screws, nuts, bolts, tools, and tires. The EU Parliament

approved these requirements in October 2010, and they are pending in the European Council. 

While the United States supports country of origin labeling requirements adopted to provide 

consumers with information about the products they buy, the United States is concerned that the 

EU’s requirements would only apply to imported products. As a result, the United States raised 

this issue with the EU at the November 2010 TBT Committee meeting. 

Hazardous Substance Restrictions

The EU’s Directive on the Restriction of the Use of Certain Hazardous Substances in 

Electrical and Electronic Equipment (RoHS) prohibits placing certain categories of electrical 

and electronic equipment on the EU market that contain chemicals such as lead, mercury, 

cadmium, and hexavalent chromium. The RoHS directive includes certain application-specific 

exemptions from the prohibitions. The EU considers requests for additional exemptions on an 

ongoing basis. 

The United States supports the EU’s objectives of protecting human health and the environment; 

however, the United States is concerned about the transparency and predictability of the EU’s 

process and timing for considering exemption requests and the absence of a common approach to 

enforcement in all EU Member States. As noted in last year’s report, the EU was expected to 

revise its RoHS directive in late 2010 or early 2011. The EU has not yet adopted revisions, 

and it is unclear when this process will move forward. The United States continues to urge 

the EU to provide an adequate opportunity for U.S. stakeholders to provide input into the 

revision process. 

On substance, the United States is urging the EU to adopt a revision that clarifies the 

relationship between REACH and RoHS and includes an improved exemption process that takes 

into account the products concerned when determining the length of time for which 

exemptions apply. The United States has also urged the EU to ensure that any decision to 

expand the RoHS directive’s scope of covered products be informed by a thorough impact 

assessment, and that any decisions regarding additional restrictions included in a revised 

directive are based on science, taking into account intended end uses and all available scientific 
74

and technical information. These revisions would help ensure transparency and legal certainty 

regarding how products will be treated. 

Ride-on Lawnmowers – Unique French Requirements

The United States continues to have concerns with respect to the French Ministry of 

Agriculture’s (MoA) “skirt” requirement for ride-on lawnmowers, a measure that France neither

published as part of an official law or decree nor notified to the WTO. The MoA requirement for 

ride-on lawnmowers already has disrupted U.S. lawnmower exports to France. If other Member 

States were to adopt this requirement, a significant portion of the approximately $1 billion in 

annual U.S. shipments of lawnmowers to Europe could be adversely affected.

The United States is not aware of any technical basis for requiring ride-on lawnmowers to be 

fitted with an extra piece of equipment (or “skirt”). U.S. officials understand that the skirt 

requirement represents a unique French requirement that is neither consistent with requirements in 

other EU Member States, nor based on internationally developed ASTM or ISO ride-on 

lawnmower standards used throughout the world. Accordingly, the United States has 

requested that the Commission share accident data it believes supports the French position 

that installation of the lawnmower skirt would increase bystander safety, and any analysis 

undertaken by the MoA on the potential fire hazard that installation of the skirt could create. 

The United States clarified that if this information does not exist or does not support the 

necessity of the skirt requirement, the Commission should recommend that France base its rideon lawnmower requirements on a relevant international standard or eliminate the skirt requirement

altogether. Both EU and U.S. lawnmower manufacturers have challenged the French 

lawnmower requirement as well. 

During 2010, the MoA worked on a revision to the EN 836 standard to address these concerns. 

In October 2010, a working group advising MoA on the revision concluded that total enclosure 

of all transmission moving parts was unnecessary, directly rejecting the MoA’s position that 

complete coverage is required. The working group also acknowledged that the risk of fire from 

total enclosure is significant, and that attention in the revision process should be shifted to the 

pinch points only, instead of concentrating on all transmission moving parts. 

While the position developed by the working group is acceptable to U.S. and European industry, 

the MoA does not appear to be wavering on its position that complete coverage is necessary. As 

a result, producers must either comply with MoA’s skirt requirement for sales in the French 

market or face recalls. In addition, U.S. companies have complained of being singled out for 

enforcement action by French customs officials. 

The United States will continue to press the EU to address this issue in 2011.

Wine – Labeling Requirements

As described in last year’s report, the EU continues to seek exclusive use of so-called “traditional 

terms” such as tawny, ruby, reserve, classic, and chateau on wine labels, but may allow third 

country producers to use such terms pursuant to an agreement with the EU or contingent on the

regulation of those terms in their home market. Under the United States – EU wine agreement, 

the EU permitted the use of certain terms on U.S. wines sold in the EU for a three-year extendable 

period, but then declined to extend the period past March 2009. As part of its effort to redesign its 
75

Common Market Organization on wine, the EU published its new regulation (EC No 607/2009) on 

July 14, 2009, laying down detailed rules for implementation of EC regulation 479/2008 with 

regard to protected designations of origin and geographical indication, traditional terms, labeling, 

and presentation of certain wine products. The regulation leaves enforcement to EU Member 

States. It is unclear how Member States will enforce the regulation or how the Commission plans 

to ensure consistency of interpretation across Member States.

The United States continues to have serious concerns regarding these measures, which severely 

restrict the ability of non-EU wine producers to use common or descriptive and commercially 

valuable terms to describe their products, on the grounds that those terms are traditionally 

associated with European wines. The United States is also concerned about continued EU

efforts to expand the list of so-called “traditional terms” to include additional commercially 

valuable terms. Some of these terms do not have a common definition across all EU Member 

States, and the United States is not aware of any effort to monitor or limit the use of those terms 

within the EU. Additionally, the United States remains concerned about the EU’s decision to 

withdraw permission to use certain “traditional terms” under the U.S. – EU wine agreement, as 

well as the EU’s limitation on the use of traditional expressions in trademarks. 

While the EU attempts to justify limitations on the use of traditional terms by indicating that they 

could be used to mislead consumers, these terms have been used without incident on U.S. wines 

in the EU market for many years, which suggests that there is no such risk. During 2011, the 

United States will continue to coordinate with the U.S. wine exporters on how best to address 

and resolve concerns regarding the EU’s wine policy.

India

Bilateral Engagement

The United States discusses TBT matters with India during TBT Committee meetings and on 

the margins of these meetings. U.S. government officials also discuss such matters with Indian 

officials under the U.S. – India Trade Policy Forum (TPF), the TPF’s Tariff and Non-tariff 

Barriers and Agriculture Focus Groups, the U.S. – India Commercial Dialogue and the HighTechnology Cooperation Group. 

In addition, the U.S. Trade and Development Agency (USTDA) is also funding a program with 

the Confederation of Indian Industry (CII) to facilitate India’s development of a transparent and 

more streamlined system of standards, conformity assessment, and technical regulations. CII 

and ANSI have added India-specific content to ANSI’s standards portal 

(www.standardsportal.org). CII and ANSI also held workshops on standards for safe storage of 

liquefied natural gas and aerospace standards in February 2010, and held an exchange on 

biometrics standards under this initiative in July 2010. 

Cosmetics – Registration Requirements

U.S. industry has raised concerns regarding India’s proposed “Drugs and Cosmetics (Amendment) 

Rules, 2007.” In particular, the U.S. industry expressed concerns about initial aspects of India’s 

proposal, including a proposed registration system that only appeared to be targeted at imports. 

U.S. industry was concerned that these requirements would create an unreasonably costly and 
76

burdensome registration system and would result in unnecessary delays for cosmetic products 

being brought to market. 

The United States shared industry’s concerns and requested India to notify the measure to the 

WTO, to delay enforcement to allow a reasonable time for Members to comment, and to afford 

suppliers a reasonable period to comply with the new requirements. India eventually notified the 

measure, and the United States submitted comments including concerns raised by U.S. 

stakeholders through India’s TBT Inquiry Point.

In response to U.S. comments, India’s Ministry of Health (MoH) made a number of 

clarifications and modifications to the proposed measure in 2009 and, in July 2010, issued 

Guidelines on Import and Registration of Cosmetics. These guidelines provide additional 

clarity, such as clarifying the definition of “brand”; allowing manufacturing sites of a parent 

company to be registered under a single registration; applying a single registration fee to all 

product lines of the same brand; and providing for fast track review of products currently on the 

market. U.S. industry continues to express concerns regarding whether there will be an 

adequate compliance period and whether stickering will be allowed for country-specific 

information, among other issues. The United States will continue to raise these issues with India 

in 2011. 

Food and Distilled Spirits – Nutritional Labeling

The United States is concerned by nutritional labeling requirements that India adopted in 2009. In 

particular, the United States is concerned that India’s measure requires labels of distilled spirits 

to provide the date of production, which is irrelevant in the case of distilled spirits since such 

products have an indefinite shelf life. The United States is also concerned with further 

requirements addressing: (1) the labeling of proprietary foods; (2) the declaration and 

calculation of certain nutrient values; (3) the criteria for labeling a product as “trans fat free”; (4) 

the allowance of stickering on products; and (5) the rules for front of pack flavoring declarations 

using the statement “CONTAINS ADDED FLAVOUR.” 

The United States has repeatedly expressed concerns about this issue directly to India in writing 

and at the margins of TBT Committee meetings. India has not been responsive to U.S. 

concerns. Most recently, in February 2010, the U.S. government submitted further comments to 

India on its outstanding concerns, but India has not addressed these concerns. The United States 

will continue to press India to resolve this issue in 2011. 

Telecommunications Equipment – Information Security Regulations

U.S. industry has raised significant concerns with a number of telecommunications equipment 

requirements that India’s Department of Telecommunications has adopted, including licensing 

amendments adopted in December 2009 and March 2010, and a “template agreement for security 

and business continuity” adopted in July 2010. These requirements would be a mandatory part of 

private commercial contracts between foreign telecommunications service providers and vendors 

of foreign telecommunications-related equipment, products, and services in India. However, they 

would not apply to telecom equipment and products manufactured in India. Under these 

measures, any vendor seeking to sell foreign manufactured telecom equipment and products to 

Indian telecom service providers would be required to: (1) deposit their source codes in escrow; 
77

(2) transfer their technology to Indian companies; and (3) follow burdensome testing and 

certification requirements. The U.S. and global telecom equipment industries have indicated these 

requirements could halt billions of dollars of equipment sales in India. 

U.S. government officials have raised this issue with India in many different fora and at many 

different levels of government, including in the TBT Committee and during the September 2010 

U.S.-India Trade Policy Forum. U.S. officials also raised this issue with officials of India’s Office 

of the Prime Minister before President Obama’s visit to India in November 2010.

In response to U.S. comments, India suspended its implementation of the “template agreement” 

and agreed to review its security requirements. In January 2011, the Ministry of Communications 

and Information Technology announced a 100-day action plan to develop a new security regime 

for telecom equipment. At this time, it appears that India is planning to base its regime on the 

problematic template agreement. Further, India has not yet announced a transparent process for 

developing this new regime. The United States continues to urge India to provide a draft of any 

revised regulations so that interested parties have an opportunity to provide comments. 

Indonesia

Bilateral Engagement

The United States discusses TBT matters with Indonesia both bilaterally and during meetings of 

the TBT Committee. The United States – Indonesia TIFA Council provides a forum for 

bilateral discussions on a variety of trade-related issues, including standards-related issues. 

Indonesia also participates actively on standards and conformance issues in APEC.

Bahasa Labeling Requirement

In September 2010, Indonesia announced that it will require all imported products to bear 

original labels in the Bahasa language and will require these labels to be affixed to processed 

food products before they are shipped to Indonesia. Previously, Indonesia had permitted 

importers in Indonesia to apply sticker labels with Bahasa translations once imported products 

cleared customs. This new policy will significantly raise compliance costs for U.S. industry and 

could completely shut off U.S. processed product exports to Indonesia, resulting in a market loss 

of up to $220 million on an annual basis. 

The United States raised this issue with Indonesia during the TBT Committee meeting in 

November 2010. U.S. officials noted that Indonesia has not clearly explained the new labeling 

rule to its trading partners nor notified it to the WTO. 

The United States and Indonesia held a series of meetings in February 2011 to try to resolve this 

issue. During these meetings, Indonesian officials indicated that producers could comply with 

the new Bahasa language requirements by applying supplementary labels, but refused to clarify 

whether “stickers” would be considered adequate for this purpose. Indonesian officials also did 

not clarify whether the supplementary labels could be affixed at the port of entry after products 

clear customs.

The United States will continue to urge Indonesia to clarify outstanding issues arising from its 
78

new labeling measure and to consider suspending its implementation in order to notify the 

measure to the WTO and take comments into account from interested parties. 

Food, Supplements, Drugs, and Cosmetics – Distribution License Requirements

In August 2009, Indonesia issued proposed requirements governing the distribution of food, 

food supplements, drugs, and cosmetics. The proposed requirements prohibited the distribution 

of food, food supplements, drugs, and cosmetics in Indonesia without first obtaining a distribution 

license. The criteria for receiving a license differed by product type and were based on several 

factors, including whether certain ingredients are halal. 

For example, under these proposed requirements, any pharmaceutical products or drugs containing 

certain animal substances would not qualify for a distribution license in the absence of an 

“emergency,” and all such products would be required to bear a label indicating “Swine 

Content.” Further, drug products manufactured using substances sourced from swine in the 

production process would be required to bear a label indicating that: “The manufacturing process 

involves a substance that [is] sourced from swine and has been purified so that [it is] not 

detected on final product.” Food sourced from swine would be subject to a separate set of 

emergency procedures. Distribution licenses also could not be awarded for products containing 

alcohol, such as certain pharmaceuticals, cosmetics, and food flavorings. 

Indonesia’s proposed requirements threatened to disrupt U.S. exports to Indonesia of foods (many 

flavorings contain alcohol, sometimes in de minimis amounts); drugs (many products, such as 

cough syrups and other over-the-counter drugs, contain alcohol and others, such as gelatin 

capsules and vaccines, are sourced from swine); and cosmetics (many products contain alcohol). 

The United States was particularly concerned that the requirements could have disrupted trade in 

critical medicines, such as vaccines, as well as trade in many other products. 

 

The United States raised concerns about Indonesia’s proposed requirements in the TBT 

Committee in 2009 and 2010. The United States explained that while it respected Indonesia’s 

right to regulate halal products, Indonesia should have developed and proposed to apply its 

requirements affecting trade in halal products in a transparent manner and should have made 

additional efforts to ensure that the measures would not disrupt trade. In addition, the United 

States conveyed its concern that many of the operational details of the licensing system were 

unclear. The United States requested Indonesia to suspend enforcement of the measure until it 

notifies it to the WTO and takes comments from trading partners into account. 

As a result of U.S. efforts, Indonesia agreed to revoke the measure. During the November 2010 

meeting of the TBT Committee, Indonesia confirmed that the measure had been revoked. 

Meat and Poultry – Halal Certification

Indonesia only allows the sale of meat and poultry products that have been certified halal by 

certifiers recognized by Indonesia’s Council of Ulama (“MUI”). Halal certification involves 

certifying that the product has been slaughtered and handled in a manner consistent with Islamic 

law. 

On March 9, 2009 MUI issued a decree announcing that a new list of MUI recognized halal 
79

certifiers would become effective October 1, 2009, superseding all previous MUI recognized 

halal certifiers. MUI did not make publicly available or notify to the WTO the new procedures 

and criteria for recognition and inclusion of certifiers on the new list. 

MUI published the new list of halal certifiers on October 22, 2009, 21 days after the decree’s 

effective date, causing a 22 day disruption in all halal trade to Indonesia. The new halal certifier 

list did not include any halal certifiers for halal trade in poultry or lamb. The list also excluded 

several U.S. processed food halal certifiers that MUI has historically recognized. 

U.S. officials repeatedly registered concerns regarding MUI’s certifier list during TBT 

Committee meetings in 2009 and 2010. Among other issues, U.S. officials noted that the 

process to apply for and gain MUI approval was not set out in the March 2009 decree and was 

not made available to the public. As a result, many certifiers did not know whether they were

required to re-apply for approval and were not aware of the new rules for halal accreditation. 

In response to U.S. concerns, Indonesia’s TBT Inquiry Point issued a communication in May 

2010 claiming that Indonesia would accept e-mail applications from U.S. poultry and lamb 

producers for halal certifications sent to MUI. During bilateral discussions on the margins of 

the November 2010 TBT Committee meeting, Indonesian officials clarified that MUI lacks 

confidence in the U.S. slaughtering process for poultry and lamb and that it would not approve 

any applications from the United States until it conducted an audit of the U.S. halal slaughtering 

system for both poultry and lamb. MUI officials visited several U.S. facilities in December 

2010 and accredited four U.S. poultry certifiers in early 2011, restoring U.S. access to 

Indonesia’s market for halal poultry. 

While this is a welcome development, U.S. officials will continue to work with Indonesia to 

secure market access for all U.S. industries seeking to export halal products to Indonesia. 

Japan

Bilateral Engagement

The United States discusses TBT matters with Japan during and on the margins of WTO TBT 

Committee meetings. The United States will continue to raise potential TBT issues with Japan in 

bilateral fora, including the U.S. – Japan Economic Harmonization Initiative. This initiative was 

launched in November 2010 and aims to promote harmonization of approaches that facilitate 

trade, address business climate and specific trade issues, and advance coordination on issues of 

common interest. The United States intends to raise standards-related issues arising in such areas 

as agriculture, medical devices and pharmaceuticals, cosmetics, nutritional supplements, and 

information and communication technologies. 

In the area of pharmaceuticals and medical devices, for example, Japan is setting clearer 

performance measures than in the past for reviewers involved in approving new products. 

There are remaining issues, however, with the lag in the availability of new drugs and devices in 

Japan compared to their availability in other advanced nations which need to be addressed. For 

nutritional supplements, the United States has urged Japan to adopt a system allowing ingredientspecific health claims that is science-based and transparent as well as to instill greater 

transparency in the operations of Japan’s quarantine stations in order to streamline import 
80

procedures. The United States also continues to raise the need for greater clarification of

Japan’s classification criteria for drugs, foods, and food additives and the process it uses to 

categorize new ingredients. In the areas of cosmetics and “quasi-drugs,” the United States 

continues to encourage Japan to make improvements in its regulatory environment, including for 

labeling and claims, its importation procedures, and overall transparency.

The United States is also encouraging Japan to enhance the overall transparency of its regulatory 

regime and to improve its public comment procedures.

Organic Product Requirements

U.S. organics exports to Japan are limited by Japan’s ban on alkali extracted humic acid, a substance 

that USDA permits for use on U.S. organic crops. While Japan has permitted some forms of this 

substance to be used, it still bans most forms of the acid. The United States has focused its efforts 

on persuading Japan to allow the use of lignin sulfonate as a flotation device for cleaning fresh 

fruits in the organic production process, but Japan continues to request additional information 

from the United States regarding this subject. 

In addition, Japan’s zero tolerance policy for pesticide and herbicide residues on organic products 

continues to be problematic for U.S. industry. Even though these substances are not applied 

to organic crops, they are often present in the natural environment, which makes achieving

zero residue level very difficult. In addition, Japan’s zero tolerance policy appears to exceed

the Codex Guidelines for the Production, Processing, Labeling and Marketing of Organically 

Produced Foods. These guidelines apply to the process by which organic foods are 

produced, and do not mandate specific maximum residue levels for pesticides and 

contaminants. 

Largely, in response in response to U.S. engagement on this issue, Japan’s Ministry of 

Agriculture, Forestry, and Fisheries (MAFF) announced in April 2009 that it would begin 

revising Japan's requirements for organic plants, organic processed foods, organic livestock 

products and organic feeds. In 2010, MAFF established study committees comprising growers, 

retailers, consumers and academics to review different aspects of Japan’s regulations. While 

MAFF indicated that during the review process it would revisit its zero tolerance requirement 

with stakeholders, there have been no such discussions thus far. MAFF is scheduled to 

complete its review process by the end of 2011. 

The United States will continue to monitor the situation closely in 2011 and press Japan to 

modify its requirements in a manner that will improve access to Japan’s market for U.S. organic 

products.

Korea

Bilateral Engagement

Korea and the United States hold regularly scheduled bilateral consultations to address potential 

bilateral trade issues, including technical barriers, as they emerge. These bilateral 

consultations, led by USTR with participation from the full range of relevant U.S. agencies, 

serve as an important forum for discussing and resolving these issues and are augmented by a 
81

broad range of senior-level policy discussions. In 2010, bilateral trade consultations were 

held in May and September, leading to the resolution of a number of TBT issues. A similar 

slate of meetings will be held in 2011. In addition, USTR and other agency officials meet with 

their counterparts in the Korean government on a regular basis to discuss trade-related issues, for 

example, in the context of meetings of the TBT Committee.

Conformity Assessment

The pending U.S.-Korea Free Trade Agreement (KORUS) would address conformity 

assessment issues in several ways, most notably by committing Korea to provide national 

treatment in its recognition of conformity assessment bodies, to recognize conformity assessment 

bodies on the basis of published criteria, and to take steps to implement Phase II of the APEC 

Telecomm MRA with respect to the United States as soon as possible. At the current time, 

however, Korean laws and regulations generally limit the bodies that may test and certify products 

for compliance with Korean electrical safety requirements to “domestic nonprofit organizations 

equipped with suitable testing equipment and qualified testing personnel...” U.S. industry is 

concerned that the inability of U.S. testing and certification bodies to test and certify products 

for the Korean market disadvantages U.S. manufacturers on account of the fact that U.S. 

manufacturers must have their products tested and certified in Korea, which can be 

inconvenient, time consuming, and costly and cause delays to market. 

There were positive developments on this issue in 2009 and 2010 with respect to safety testing 

for lithium ion batteries and energy efficiency testing for refrigerators. In 2009, following 

active engagement by the United States, Korea agreed to allow non-Korean conformity 

assessment bodies to test for conformity with new Korean safety regulations for lithium-ion 

batteries. In May 2010, Korea issued revised regulations governing energy efficiency testing for 

refrigerators to reflect longstanding U.S. concerns. Under the revised regulations, Korea will 

accept energy efficiency data from non-Korean testing bodies, both to determine whether a 

product meets Korea’s minimum energy efficiency standards for placing a product on Korea’s 

market and as part of a challenge process under which firms can question a competitor’s energy 

efficiency test results. U.S. officials are urging Korea to adopt approaches similar to those it 

has applied with respect to batteries and refrigerators to other such products for which test 

results are required.

Motor Vehicles – Proposed Fuel Efficiency and Emissions Requirements

Since July 2009, Korea has been in the process of drafting regulations that would establish new 

fuel efficiency and green house gas emission requirements for automobiles. While the United 

States shares Korea’s interest in promoting fuel efficiency and reducing green house gas 

emissions, U.S. officials sought to ensure that the regulations were designed and drafted in a 

way that would not undermine market access for U.S. autos, while meeting Korea’s 

environmental objectives.

In December 2010, Korea agreed to include in its final regulation a provision that allows 

manufacturers that sold 4,500 or fewer automobiles in Korea in 2009 (the regulation’s base 

year) to comply with the regulation from 2012-2015 if the fleet they sell in Korea comes within 

19 percent of the new Korean requirements. In other words, the Korean fleet of qualifying 

automakers can comply with the regulation even if their fleet average fuel economy is 19 
82

percent lower than would normally be required. This will help level the playing field for U.S. 

autos in the Korean market.

Organic products – Requirements and Conformity Assessment Issues

In June 2008, Korea published its new Processed Organic Foods Regulation, with a proposed 

implementation date of January 1, 2010. The regulation would have required all products 

claiming to be organic to be certified as organic by a certification body accredited by Korea’s 

Ministry of Food, Agriculture, Forestry and Fisheries (MIFAFF). Many U.S. producers and 

certifiers have been reluctant to attempt to seek certification and accreditation under the new 

regulation, in part due to Korea’s zero-tolerance policy on biotechnology presence in organic 

products as well as due to the increased costs that compliance with the regulation would 

impose. Further, because the Korean regulation does not provide for Korea to negotiate 

agreements for equivalency or recognition of foreign organics programs, implementation of the 

regulation could have significantly impeded, or even halted, U.S. organics exports to Korea. 

In response to concerns raised by the United States and other exporting countries, in August 2010 

MIFAFF agreed to allow foreign organic products to be sold in Korea until December 31, 2012 

without having to be certified by a MIFAFF-accredited certifier. In the meantime, MIFAFF is 

revising and consolidating its organics regulations, which are expected to include a provision 

that will allow equivalency negotiations between the United States and Korea to proceed. 

The United States will continue to urge Korea to re-consider its zero-tolerance policy for 

biotechnology presence in organics.

Processed Food Products – Mandatory Biotechnology Labeling

In October 2008, the Korean Food and Drug Administration proposed expanding its mandatory 

biotechnology labeling for food products containing bioengineered ingredients to include 

processed products such as vegetable oils and distilled spirits. Under this proposal, certain 

processed products with ingredients derived from biotechnology commodities, such as corn and 

soybeans, would require a label indicating that they are derived from biotechnology products. 

The United States has concerns with the negative effect on trade that results from the potentially 

misleading nature of mandatory labeling of food products containing or derived from 

biotechnology. By expanding the scope of products covered by its mandatory labeling regime to 

include products such as distilled spirits, Korea’s proposal would result in an even greater 

disruption of trade. U.S. officials have continued to urge Korea to reconsider the need for 

expanding the regime. A decision from Korea on whether to adopt the proposed requirement 

remains pending.

Solar Panels – Design Requirements

In 2010, U.S. officials continued to raise concerns that certain types of thin-film solar panels 

(TFSP) manufactured by U.S. industry cannot be placed on the Korean market. Since July 2008, 

Korea has required solar panels to be certified by the Korea Management Energy Corporation 

(KEMCO) in order to be sold in Korea. KEMCO will only certify solar panels as safe if they 

meet the mandatory Korean standard for TFSP (KS61646:2007 Thin film terrestrial photovoltaic 
83

(PV) modules – Design qualification and type approval). This standard incorporates much of 

IEC 61646 (Thin-film terrestrial photovoltaic (PV) modules – Design qualification and type 

approval), but its application is limited to amorphous silicon (A-Si) type thin film solar panels 

whereas the IEC standard applies to all types of thin film solar panels. Korea has not adopted a 

standard for other types of TFSP.

As a result, other leading types of panels, including Cadmium Telluride (CdTe) and Copper 

Indium (di) Selenide (CIS), cannot be tested or certified under the Korean standard and 

accordingly cannot gain the necessary certification to be placed on the Korean market. Korea’s 

lack of an applicable standard for other types of TFSP will also affect panels made with 

Gallium arsenide (GaAs), which is emerging as a commercially proven technology. According to 

U.S. industry, Korea is the only country in the world that specifically restricts application of the IEC 

standard to only one of the three leading types of thin film panels.

Korea has explained that it adopted its standard based on concerns about the presence of 

cadmium in other types of solar panels or the use of cadmium in the production process. In 

bilateral discussions and in meetings of the TBT Committee, Korea has indicated that it is 

conducting a study to determine whether it might be feasible to include other types of TFSPs 

within the scope of its solar panel standard. It has stated that the study should be completed in 

2011. 

The United States recognizes the environmental dangers of cadmium and, like Korea, maintains 

legal requirements on safe use of cadmium. However, the residual level of cadmium in other 

types of solar panels, currently sold in the United States and other markets, is minimal. The 

United States is not aware of any scientific or technical evidence indicating that there are risks 

from using thin film solar panels that are not covered by the Korean version of the IEC standard. 

Thus, the United States continues to urge Korea to adopt the IEC 61646 standard without 

limiting its application to A-Si thin-film solar panels.

Malaysia

Bilateral Engagement

The United States discusses TBT matters with Malaysia during TBT Committee meetings, 

bilaterally on the margins of those meetings, and during TPP negotiations. Malaysia also 

participates actively on standards and conformance issues in APEC.

Meat and Poultry Products – Halal Standards

In December 2009, Malaysia published a final standard for halal food production. The standard 

requires meat packing facilities to be dedicated exclusively to halal production. The 

requirement exceeds the terms of the Codex halal standard, which allows producers to use 

dedicated lines for halal meat products within a facility that includes non-halal production. 

Malaysian officials have cited a lack of trust in the purity and reliability of halal meat 

production chains outside Malaysia as the basis for the new requirement, but Malaysia has 

presented no evidence to support this view, despite repeated U.S. requests.

U.S. producers have indicated that they are willing to produce to importing countries’ halal 
84

standards when those standards are reasonable and do not require an entirely segregated supply 

chain. U.S. industry estimates that U.S. exports to Malaysia of halal beef and poultry could 

grow dramatically if Malaysia adopts reasonable and reliable halal production standards and 

import licensing practices.

Malaysia has committed that its new halal requirements will take effect for U.S. producers only 

after Malaysia audits U.S. meat production facilities. Malaysia has requested to carry out 

several audits, but U.S. officials have requested further clarity on audit parameters before 

facilitating this request. 

Malaysia has failed to notify its halal standard to the WTO as a technical regulation, claiming 

that the halal standard is voluntary and does not need to be notified. However, Malaysia 

currently bans imports of non-halal meat, a practice that Malaysian officials have explained as 

useful for avoiding consumer confusion since non-halal meat products may not be sold in 

Malaysia. Contrary to this explanation from Malaysian officials, the United States has 

confirmed that non-halal products are widely available for sale in segregated portions of 

Malaysian food stores. Thus, it does not appear that Malaysia bans all non-halal products, but 

only non-halal imports. The United States will continue to raise this issue with Malaysia in 

2011. 

 

Mexico

Bilateral Engagement

The United States discusses TBT matters with Mexico during TBT Committee meetings and on 

the margins of these meetings. The United States also discusses specific trade concerns and 

systemic issues with Mexico in the context of the NAFTA and subordinate trade working 

groups (TWGs) established to address particular standards-related issues. Canada 

participates in these sessions as well. As one example, the NAFTA TWG that addresses food 

labeling and packaging helped increase cooperation among the NAFTA parties regarding food 

laboratories and nutritional labeling. The United States and Mexico also engage on standards and 

regulatory issues as part of the U.S. – Mexico High-Level Regulatory Cooperation Council, which 

was established in 2010. 

Conformity Assessment Procedures

Under Article 908.2 of the NAFTA, Mexico is required to accredit, approve, license, or otherwise 

recognize conformity assessment bodies (e.g., certification bodies or testing laboratories) in the 

United States on terms no less favorable than those applied to conformity assessment bodies in 

Mexico. While applications by U.S. conformity assessment bodies that test electrical and 

electronic goods for accreditation had previously been delayed, these applications were finally 

approved in 2007 and 2008. 

Despite this positive development, the United States continued to ask Mexico for further 

clarification of its accreditation procedures to ensure that Mexico will continue to provide nondiscriminatory treatment for all conformity assessment bodies, including those located in the 

United States. In particular, the United States urged Mexico to clarify whether an application for 
85

a new accreditation or an expansion of an existing accreditation can be submitted at any time or 

only in response to a specific call to certifiers. The United States also urged Mexico to set a 

reasonable period for evaluating accreditation requests so that U.S. conformity assessment 

bodies can avoid long delays in the accreditation process. 

Significant progress was made on this issue in 2010. In August, Mexico announced that it 

would recognize testing and certification results from certain conformity assessment bodies in 

the United States (as well as Canada). In particular, Mexico indicated that testing and 

conformity assessments conducted in the United States that indicate that certain electronic 

products comply with U.S. requirements would be sufficient to demonstrate conformity with 

Mexican requirements. As a result, U.S. suppliers will no longer need to re-test and re-certify 

their products to Mexican requirements to ship them to Mexico. According to industry, this 

change will save companies that manufacture these products, on average, several hundred 

thousand dollars or more annually in compliance costs. 

Certain Mexican conformity assessment bodies have challenged this determination in court, 

which has prevented some U.S. suppliers from taking advantage of Mexico’s willingness to 

accept test results from U.S. conformity assessment bodies. However, the United States has 

received no reports that have chosen to satisfy Mexico’s product requirements by choosing to 

have their products tested in the United States have encountered problems in exporting those 

goods to Mexico. 

In 2010, Mexico also announced new rules that would streamline conformity assessment 

procedures for shipments of medical devices and certain over-the-counter (OTC) drugs from the 

United States. Under these rules, any producer or importer of medical devices or equipment can

obtain a sanitary registration within 35 days, provided that U.S. regulators have approved the 

product for sale. This agreement reportedly has also been the subject of a legal challenge by 

Mexican producers. 

Mexico’s steps in this area are welcome and the United States will continue to monitor this area 

in 2011 to ensure that U.S. companies can take full advantage of the new opportunities Mexico 

has provided. 

Food Products – Nutritional Labeling

In 2009, Mexico proposed to amend its nutritional labeling requirements, notifying to the 

WTO for comment the “Draft Mexican Official Standard PROY-NOM-051-SCFI/SSA 1-2009: 

General Specifications for the Labeling of Pre-packaged Food and Non-alcoholic Beverages 

- Commercial and Health Information” (NOM-051). Mexico asserted that the purpose of these 

proposed requirements was to provide consumers with greater information.

The United States submitted comments to Mexico on the proposal that posed technical questions 

and expressed concerns about the possible trade implications of the proposed measure. In 

particular, the United States expressed concerns about the impact that the labeling requirements 

could have on small packages and low volume producers, who were not originally exempt from 

the law, as well as about a lack of clear guidance on how Mexico would implement the labeling 

requirements. The United States also expressed concern that the measure would require a 

compliance certificate for all imported products, which could halt exports of processed food 
86

products. 

Significant progress was made on this issue in 2010. First, the United States and Mexico engaged 

in a dialogue that clarified many of the issues regarding the proposed labeling measure, including: 

(1) Mexico’s proposed requirements for disclosures regarding irradiated foods, compound 

ingredients and quantitative ingredients; (2) the scientific basis for Mexico’s Recommended Daily 

Allowance (RDA) values, including how Mexico took Codex RDA values into account; (3) the 

basis for Mexico’s energy calculations; and (4) the use of voluntary claims such as “natural,”

“halal,” and “organic”. Second, Mexico delayed implementation of the labeling rules from 

June 2010 to January 1, 2011, providing U.S. industry with additional time to comply. Third, 

in October 2010, Mexico issued a communication alleviating the U.S. concerns regarding the 

requirement to provide a compliance certificate. Finally, Mexico also agreed to include an 

exemption for imports shipped in small packages. 

The United States is pleased with Mexico’s willingness to modify its requirements to address 

U.S. concerns. In 2011, the United States will continue to monitor the implementation of 

Mexico’s labeling requirements to ensure that they do not have an adverse effect on U.S. 

exports.

Telecommunications Equipment – Acceptance of U.S. Test Results

When the United States and Mexico signed the NAFTA, Mexico committed to adopt provisions 

necessary to accept test results from test laboratories in the United States as part of its conformity 

assessment procedures for telecommunications equipment. Until recently, Mexico had not moved 

forward to carry out its commitment, which could be implemented by concluding a MRA with the 

United States. Mexico’s failure to do so prevented U.S. laboratories from testing 

telecommunications equipment for the Mexican market, and imposed additional costs on U.S. 

producers who were forced to send their products to Mexico for testing. 

At the January, 2011 NAFTA Free Trade Commission meeting, the United States and Mexico 

committed to enter into a bilateral telecom MRA. During the meeting, Ambassador Kirk and 

Mexican Secretary of Economy Fernando Ruiz Mateos initialed a reference document laying out 

the basic terms of such an agreement and established a goal of signing the MRA by May 2011. 

The United States is currently working with Mexico to draft the MRA. 

Russia

Bilateral Engagement

The United States engages with Russia regarding its technical regulations, standards, and 

conformity assessment procedures both on a bilateral basis and in the context of negotiations 

on Russia’s accession to the WTO. (Once Russia joins the WTO it will be required to adhere 

to the TBT Agreement.) In addition, the Working Group on Business Development and 

Economic Relations established under the U.S. – Russia Bilateral Presidential Commission provides 

a forum for the United States and Russia to discuss, among other matters, standards-related 

regulatory cooperation.

Alcoholic Beverages – Tax Strip Stamp Requirement
87

In February 2010, Russia amended its laws to make all domestic alcohol producers and 

importers subject to the same requirements for labeling alcoholic beverages. As a result, 

Russia’s United Federal Automated Information System now requires importers and domestic 

manufacturers of alcoholic beverages to print Universal Product Code data on small paper excise 

stamps attached to each bottle. The stamps must be sequentially-numbered, and importers and 

suppliers must prepare a consolidated document at the end of the year for all the strip stamp 

numbers. Further, suppliers and importers must report these stamps through an automated 

system for purposes of taxation and a manual system for customs purposes. 

Russia’s amended law represents a significant improvement over its previous system, which 

accorded different treatment for imported and domestic products. U.S. industry has indicated 

that the new reporting requirements are burdensome, however, and have disrupted U.S. exports 

to Russia. U.S. government reports also indicate that Russia’s new system is expensive, 

difficult to use and, thus far, has been unsuccessful in meeting its goal of tracking alcohol from 

manufacture or importation to the retail sales point. In 2011, the United States will urge Russia 

to revise the stamp requirements to address these concerns. 

Alcoholic Beverages – Warehousing Requirements

In October 2010, Russia’s Federal Service for Alcohol Market Regulation (FSR) adopted 

regulations governing the storage of alcoholic beverages. The United States is concerned that 

these regulations impose onerous and unfounded restrictions on this practice. For example, the 

regulations prohibit storing different types of alcohol on one pallet; require that alcohol products 

be stored at least 15 cm from the floor; and preclude other goods from being stored with alcohol 

products. It is unclear what objective these requirements are intended fulfill. Further, they 

unnecessarily restrict access to the Russian market for U.S. alcoholic beverage exporters. In 

2011, the United States will urge the FSR either to modify or abandon its new regulations. 

Saudi Arabia

Bilateral Engagement

The United States engages with Saudi Arabia on TBT issues through the Trade and Investment 

Framework Agreement and at the TBT Committee.

Conformity Assessment Procedures – Lack of Transparency

In 2006, Saudi Arabia introduced a Certificate of Conformity (CoC) Program. With certain 

exceptions, this program requires every shipment of products sold in Saudi Arabia to be 

accompanied by a document certifying that the product conforms to the relevant Saudi technical 

regulation ("conformity certificate"). 

U.S. exporters have had difficulty complying with this requirement because Saudi Arabia has 

not provided detailed public guidance in English on how to do so, despite Saudi Arabia’s 

commitment at the time it acceded to the WTO to provide such guidance. For example, it is not 

clear whether U.S. conformity assessment bodies may perform testing or certification that 

satisfied Saudi requirements or whether U.S. exporters must work with Intertek, a company with 
88

which Saudi authorities had originally contracted to provide services under the country’s the now 

abolished International Conformity Certification Program. Intertek currently claims through its 

internet website to operate Saudi Arabia’s product assessment program. 

The United States has raised this issue with Saudi Arabia both bilaterally and in meetings of the 

TBT Committee since 2006. In particular, the United States has raised concerns that Saudi Arabia 

has still not issued guidance in English on how to comply with its CoC requirements or dissolved 

Intertek’s web site. The United States has also urged Saudi Arabia to publish guidance on 

how to comply with the CoC, including the criteria that Saudi Arabia uses to recognize bodies 

to test and certify products for the Saudi market, and a list of conformity assessment bodies that 

are approved to provide testing and certification for the Saudi market.

U.S. officials discussed this issue most recently with officials of the Saudi Arabia Standards 

Organization (SASO) in late 2010. SASO officials clarified that SASO enters into 

government-to-government MRAs and government-to-private body MRAs to recognize 

conformity assessment bodies. Before entering into an MRA with Saudi Arabia, the United 

States has requested that Saudi Arabia establish a new central website to provide information on 

CoC requirements. In particular, the United States has requested that the website : (a) list entities 

that Saudi Arabia has approved to test and certify products for the Saudi market; (b) set out the 

criteria and procedures that the Ministry of Commerce uses to recognize bodies to test and certify 

products for the Saudi market; (c) set out clear procedures for approved bodies to follow when 

issuing conformity certificates or marks to convey that a product complies with the relevant Saudi 

requirements; (d) clarify when testing is required (e.g., for each individual shipment or once for 

each product type); and (e) indicate whether those procedures will change if Saudi Arabia adopts 

the conformity assessment scheme being developed by the Gulf Standards Organization. 

The United States has also requested information from SASO, which is an affiliate member of 

the ILAC MRA, on how it is promoting acceptance of the ILAC MRA in Saudi Arabia. The 

United States has asked, in particular, for information on whether SASO takes into account 

whether a conformity assessment body has been accredited by an ILAC MRA signatory in 

determining whether to enter into an MRA with that body.

South Africa

Bilateral Engagement

The United States discusses TBT matters with South Africa during TBT Committee 

meetings and bilaterally on the margins of these meetings, as well as in the U.S.-South 

Africa Agreement Concerning the Development of Trade and Investment. 

Liqueurs – Alcohol Content Restrictions

U.S. industry has expressed concerns about South Africa’s standards for alcohol levels in certain 

alcoholic beverages, asserting that South Africa sets and applies those standards in a manner that 

excludes and discriminates against foreign alcoholic beverages. South Africa classifies 

“liqueurs” as beverages having a minimum alcohol content of 24 percent and classifies “spirit 

coolers” as beverages having 15 percent or less alcohol by volume. On the other hand, South 

Africa does not maintain any classification for spirit-based alcoholic beverages with an alcohol 
89

content of between 15-24 percent, with the exception of products that fall into the “Cream 

Liqueur” classification, namely spirit based alcoholic beverages that contain a dairy product. As 

a result, any U.S. products that fall into this range cannot be sold in South Africa. 

Not only have these requirements kept certain U.S. products out of the market, but industry has 

reported that South Africa may not be applying its requirements equally to domestic and 

imported products. In particular, U.S. industry has reported that South Africa has granted at 

least one exception to its requirements for domestic products. 

During 2011, the United States will continue to investigate U.S. industry concerns with South 

Africa’s alcoholic beverage standards and, if appropriate, will urge South Africa to eliminate or 

modify its “liqueur” definition so that U.S. alcoholic beverage producers can sell their products 

in South Africa.

Taiwan

Bilateral Engagement

The United States discusses TBT matters with Taiwan during TBT Committee meetings and 

bilaterally on the margins of these meetings. 

Ceiling Panels – Requirements for Incombustibility Testing Methods

U.S. companies that manufacture finished interior building materials, such as ceiling panels and 

wood paneling, have raised concerns regarding the test method that Taiwan mandates for 

determining whether those materials meet applicable incombustibility requirements. Industry 

has complained that Taiwan’s current test method for ceiling panel incombustibility, which is 

similar to the current ISO standard, results in inconsistent and inaccurate incombustibility 

measures because the ISO standard was not meant to be applied to the testing of ceiling tiles. 

As a result, ceiling tiles manufactured in the United States are given a lower incombustibility 

rating than is otherwise warranted and, in some instances, fail the test altogether. 

The United States has raised these concerns with Taiwan, including on the margins of the TBT 

Committee meeting in November 2009. In response, Taiwan's Bureau of Standards, Metrology, 

and Inspection (BSMI) has indicated it would consider adopting a new ISO standard when it is 

approved. In the meantime, Taiwan has indicated that it is open to accepting, an alternative 

approach, including using an Underwriters Laboratories (UL) certification of ceiling tile 

manufacturing plants if U.S. firms provide additional information on the UL certification 

process and permit BSMI to visit their U.S. plants.

Commodity Goods – Labeling Requirements

U.S. industry continues to express concern that Taiwan requires all “commodity goods” to be 

labeled with the manufacturer’s or producer’s name, telephone number, and address. In addition 

to concerns over protecting proprietary information, industry notes that some commodity goods 

may be produced by several different manufacturers, and product labels may not be large 

enough to contain each name, address, and phone number. The U.S. officials have raised these 

concerns with Taiwanese representatives, including on the margins of the TBT Committee 
90

meeting in November 2009. Taiwan is working to revise the relevant labeling requirements for 

textiles, garments, and 3C (computer, communication, and consumer electronics) information 

products. The United States will continue monitor Taiwan’s progress is addressing this issue. 

Product Multipacks – Labeling Requirements

In March 2009 U.S. industry raised concerns over a reinterpretation by Taiwan’s Ministry of 

Economic Affairs (MOEA) of its Commodity Inspection Act and Commodity Labeling Act to 

require all units included in a retail multipack to be labeled, even if the retailer will not divide up 

the multipack for sale as single units. For example, the new rules will require a country of 

origin label for each pair of socks included within a sock multipack, even when the socks are 

sold as a six-pack. U.S. suppliers have asserted that this requirement imposes unnecessary 

additional costs as it will force them to add additional labels on their products to continue 

exporting to Taiwan. 

U.S. officials raised this issue with their Taiwanese counterparts during the November 2009 

TBT Committee, as well as on the margins of that meeting, and then followed up with questions 

during the WTO’s review in 2010 of Taiwan’s trade policies. Taiwan officials have responded 

that Taiwanese consumers typically purchase bulk items such as socks in individual units rather 

than multipacks so individual units included in multipacks must be labeled to avoid the risk of 

fraudulent country of origin labeling. U.S. officials have requested Taiwan to notify the WTO 

of its revised labeling rules, which will an opportunity for WTO Members to comment. MOEA 

is currently considering the request.

Thailand

Bilateral Engagement

The United States discusses TBT matters with Thailand during, and on the margins of, meetings 

of the TBT Committee as well as in bilateral dialogues such as the Thailand TIFA Council and 

the Bilateral Consultative Mechanism. Thailand also participates actively in APEC on standards 

and conformity assessment issues.

Alcoholic Beverages – Labeling Requirements

In January 2010, Thailand notified the WTO of a proposed regulation that would require alcohol 

beverage labels to include warning statements and photo images. The images would graphically 

depict certain potential adverse consequences of consuming alcohol, such as road accidents and 

diseased organs. The draft regulation also specifies that at least 50 percent of one side of square 

shaped packaging, or 30 percent of round or cylindrical shaped packages, must be allocated for 

the warning statements and images. In addition, the draft regulation calls for the various sets of 

warning labels and images to be rotated every 1,000 packages.

The United States raised concerns about the draft regulation during both the June and November 

2010 TBT Committee meetings. Australia, Brazil, Chile, the EU, Mexico, New Zealand, and 

Switzerland expressed concerns as well. During the June TBT Committee meeting, Thailand 

distributed a report entitled “Why Thailand Should Have the Pictorial Warning Label on 
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Alcoholic Beverage Packages: A Technical Report, June 2010.” Thailand said that it would 

accept comments on the report through its TBT Inquiry Point. 

In its comments on Thailand’s proposed labeling requirements, the United States requested

Thailand to lay out the scientific basis for the specific warning statements it sought to require on

alcoholic beverage packages. The United States also expressed concerns that the proposed size 

of the warning label in proportion to the size of the container would interfere with displaying 

legitimate trademarks and useful consumer information on alcoholic beverage containers, such 

as information necessary to distinguish one product from another. The United States also 

indicated that the requirement to rotate warning statements every 1,000 bottles could impose an 

onerous and potentially trade restrictive burden on producers, and was potentially unnecessary 

to achieve Thailand’s objective of addressing the harms associated with alcohol consumption. 

In light of the scale of the proposed changes, the United States asked Thailand to lengthen the 

implementation period for regulation. Thailand responded that it was considering the U.S. 

concerns and that it would provide a reply as soon as one was available. 

In September 2010, the U.S. Department of Agriculture hosted Thai officials in Washington to 

share best practices for encouraging responsible drinking, including best practices for warning 

labels. The United States will continue to engage Thailand on this issue in 2011. 

“Snack Food” – Labeling Requirement

Thailand has imposed problematic labeling requirements for snack foods. Thailand requires snack 

foods to be labeled with a message stating: “Should consume small amounts, and exercise for a 

better health.” While this labeling requirement represents a significant improvement over a 

labeling requirement that Thailand proposed in 2006, which would have instituted “traffic light” 

labeling meant to indicate the risks associated with certain categories of products, the United 

States remains concerned that the new requirement deviates from the prevailing scientific and 

technical information on health and nutrition. Further, Thailand’s requirement creates a strong 

potential of impeding U.S. exports of these products. 

The United States has engaged with Thailand on its snack food labeling rules since it announced 

its first proposal in 2006. The United States will continue to raise these requirements and other 

Thai food labeling regulations with Thai authorities with a view to ensuring that Thai requirements 

are based on relevant scientific and technical information on diet and nutrition and adopt an 

approach that encourages better health while avoiding trade disruption. To this end, the United 

States hosted a team of Thai regulatory officials in November 2010, to provide information 

about the U.S. food labeling system.

Turkey

Bilateral Engagement

The United States discusses standards-related issues with Turkey during TBT Committee meetings 

and bilaterally on the margins of those meetings. The United States also discusses these issues 

under the U.S. - Turkey Trade and Investment Framework Agreement (TIFA) and in the newly 

established bilateral ministerial level Framework for Strategic Economic and Commercial 

Cooperation (FSECC). The FSECC is co-chaired on the U.S. side by Ambassador Kirk and 
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Secretary of Commerce Gary Locke and on the Turkish side by Deputy Prime Minister Ali 

Babacan and Minister of Trade Zafer Caglayan. The FSECC is designed to reinforce the work of 

several bilateral sub-cabinet level dialogues on economic matters (including under the USTR-led 

TIFA) and to provide political-level guidance on particularly challenging commercial and 

economic issues. 

Conformity Assessment Requirements

In recent years, Turkey has published a series of communiqués in its Official Gazette requiring 

certificates of conformity for certain types of products imported from outside the EU and 

requiring those products to undergo product safety inspections before they clear customs. Since 

these requirements were first published in December 2008, Turkey has revised them annually.

The communiqués now in force include No. 2011/8 – radios and telecommunications 

equipment; 2011/9, which covers a broad range of “high risk products,” such as machinery, 

to be inspected by the Turkish Standards Institute; 2011/10 – toys; 2011/11 – personal 

protective equipment; 2011/14 – building materials; 2011/15 – batteries; and 2011/16 – medical 

equipment. Turkey has not notified any of these measures to the WTO.

The United States is concerned about numerous aspects of these measures, including the 

fact that they do not apply to domestically-manufactured products or products originating in 

the EU. In addition, Turkey has not explained its rationale for adopting the import measures, has not 

revealed its product inspection criteria, and has not explained it compiled the list of products to 

which the measures apply. U.S. industry has reported that the measures are affecting numerous 

U.S. exports and that the time required for customs clearance has increased significantly. U.S. 

suppliers also contend that the paperwork requirements associated with the requirements are both 

redundant and costly. 

The United States has raised concerns with Turkey both bilaterally and in the TBT Committee 

regarding its import inspection and certification requirements and pressed Turkey to reduce 

customs clearance times. U.S. officials have also urged Turkey to notify the relevant measures to 

the WTO and to provide stakeholders with an opportunity to provide comments and a reasonable 

period for implementation. The United States will continue to engage with Turkey on in 2011. 

Food and Feed Products – Mandatory Biotech Labeling

In 2009, Turkey’s Ministry of Agriculture published a regulation governing biotechnology in food 

and feed that did not have to be approved by the Parliament. The measure was neither made 

public nor notified to the WTO in advance, and contained no phase-in period. Turkey published 

an amended regulation in early 2010. The amended regulation is nearly identical to the 

original regulation and likewise contained no phase-in period (i.e., it became effective on the 

date of publication. In August 2010, Turkey notified the regulation to the WTO.

Turkey’s regulation mandates the labeling of bio-engineered ingredients in all food and feed in 

if the biotech content exceeds a certain threshold, a requirement that may could impede U.S. 

food and feed exports to Turkey. In addition, Turkey’s regulation goes beyond mandatory 

method-of-production labeling by requiring that “GMO” labels on food should contain health

warnings if the biotechnology food differs from the non-biotechnology food. 
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This labeling requirement raises additional concerns because it appears to presume that food 

containing biotechnology products that is different from its non-biotechnology food counterpart 

raises a health risk beyond that of its non-biotechnology counterpart. In fact, however, a

biotechnology food might be different from a non-biotechnology food in ways that do not 

convey health risks; consequently, such health warnings would unnecessarily cause public alarm 

while providing no additional public health protection. For example, changes in oil composition 

could lead to health benefits, and the oil could still be as safe for consumption as similar oils. 

Thus, the use of health warnings in the absence of a legitimate health concern could misinform 

the public about the safety of the food.

The United States has repeatedly raised concerns about Turkey’s labeling requirement during 

meetings of the TBT Committee and bilaterally and will continue to do so in 2011.

Medical Devices – Reimbursement and Regulatory Requirements

The United States has concerns with Turkey’s new medical device reimbursement regulation, 

Communiqué SUT 2010/16, which appears to add a duplicative regulatory burden. Turkey’s 

Ministry of Health has long had sole responsibility for the regulation of medical devices. 

However, beginning June 15, 2010 Turkey is requiring producers of medical devices used in 

spinal, orthopedic arthroplasty, and traumatology procedures to comply with regulations 

administered by Turkey’s Social Security Institute as well. Turkey’s new regulation requires 

medical device producers to supply additional documentation to maintain current reimbursement 

levels. If a medical device producer does not comply with these new regulations by the end of 

2010, Turkey would cancel all reimbursements. 

Turkey’s has asserted that it requires this additional documentation for quality assurance

purposes. It is unclear how the additional documentation will help achieve this objective, 

however, in light of the fact that Turkey’s Ministry of Health, which oversees medical device 

safety and efficacy, does not require such documentation. 

The United States has urged Turkey to notify its new requirements to the WTO, to meet with 

industry stakeholders so that they can share their concerns, and to take action to eliminate or 

modify any documentation requirements that are not needed to satisfy the requirements of 

Turkey’s Medical Device Directive. Turkey has not yet responded to these requests, and the 

United States will continue to engage with Turkey on this issue in 2011. 

Olive Oil and Olive Pomace Oil – Quality and Identity Standards

On September 2, 2010, Turkey’s Ministry of Agriculture and Rural Affairs notified a proposed 

“Turkish Food Codex Communiqué on Olive Oil and Olive Pomace Oil” to the WTO. The 

proposal defines the characteristics necessary for a vegetable oil to be labeled as “olive oil” or 

“olive pomace oil.” The proposal sets limits for the presence of fatty acids (e.g. linolenic acid) 

and campesterol that are characteristic of olive oil produced in the Mediterranean region, but do 

not take into account variations in olive oil arising from climate and soil conditions outside the 

Mediterranean. As a result, this proposal would not allow products derived from olives grown 

outside the Mediterranean region to be classified as “olive oil” or “olive pomace oil,” which could 

adversely impact U.S. exports of olive oil. 
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The United States will engage Turkey on this issue in 2011.

Pharmaceuticals – GMP Decree

In late 2009, Turkey’s Ministry of Health issued a “Regulation to Amend the Regulation on the 

Pricing of Medicinal Products for Human Use,” which took effect on March 1, 2010. The 

regulation requires foreign pharmaceutical producers, as a condition of exporting their products 

to Turkey, to secure a Good Manufacturing Practice (GMP) certificate based on a plant 

inspection by Turkish authorities. The requirement does not apply if the country of manufacture 

is a party to an MRA with Turkey. 

While it does not oppose inspection requirements for pharmaceutical manufacturing facilities, 

the United States has raised several concerns about this measure with Turkey. First, the United 

States expressed concerns that Turkey did not publish or notify the regulation to the WTO. 

Second, the United States expressed concerns that Turkey did not initially identify any health or 

safety issue arising from imports from the United States or other countries that prompted it to 

discontinue accepting GMP certificates issued by foreign regulatory authorities, such as the U.S. 

Food and Drug Administration. After several requests, Turkey provided the United States with 

a list of recalled U.S. pharmaceutical products, which it claims was the impetus for its 

regulations. The United States noted that while some U.S. pharmaceutical products have been 

the subject of recalls, the recalls should be viewed as a sign that the current U.S assurance

system is working.

U.S. industry also raised concerns about Turkey’s inspection requirement, including the fact that 

numerous approvals are pending and Turkey may not have sufficient capacity to inspect all of 

the manufacturing plants that need to be inspected in the near future. Given the apparent lack of 

inspection capacity, the United States is concerned that the process for obtaining approval could 

take several years, effectively precluding U.S. exports of important pharmaceutical products to 

Turkey. 

In 2010, the United States used various opportunities to raise its concerns over the new 

inspection requirement with Turkey, and will continue to do so in 2011. The United States has 

urged Turkey to take immediate steps to restore access for safe, high quality U.S. 

pharmaceuticals to the Turkish market, including by promptly processing registration 

applications that U.S. producers submitted before March 2010 and giving priority to innovative 

drug applications that offer new medicinal therapies for Turkish patients. 

Vietnam

Bilateral Engagement

The United States discusses standards-related issue with Vietnam during TBT Committee 

meetings and on the margins of TPP negotiations, as well as through the bilateral U.S. – Vietnam 

Trade and Investment Framework Agreement (TIFA) Council, which meets regularly and serves 

as a forum for raising and resolving trade and investment issues and for promoting increased 

technical cooperation activities. The United States has also partnered with Vietnam in advancing 

standards and conformity assessment issues in APEC.
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Alcoholic Beverages – Food Safety Regulations for Alcohol

On March 24, 2010, Vietnam notified the WTO about a proposed regulation on food safety for 

alcoholic beverages. The proposed regulation specified the management and technical 

requirements relating to raw materials for processing alcoholic beverages, including chemical 

and microbiological parameters, heavy metals, and food additive and labeling requirements. 

Vietnam’s proposal also required a compliance certification stamp and imposed new inspection 

and testing requirements for products covered by the regulation. 

On May 19, 2010, the United States submitted comments to Vietnam, expressing concerns with 

numerous aspects of the proposal, including the proposed maximum level for aldehydes in 

distilled spirits of 5 mg per liter of pure alcohol. Standards of identity for spirits in most 

international markets are based on raw materials and production processes, not the chemical 

composition of the product. As such, these standards typically do not contain limits on 

aldehydes. In its comments, the United States also raised concerns about other aspects of 

Vietnam’s proposal and asked Vietnam for clarification on the compliance certification stamp 

requirement as well as the new inspection and testing requirements. 

In response to U.S. concerns, Vietnam withdrew its proposed maximum level for aldehydes in 

most distilled spirits in December 2010. However, Vietnam did not immediately withdraw this 

requirement for vodka, which affected up to $3.5 million in U.S. exports to Vietnam in 2010. 

U.S. officials continued to press Vietnam on this issue at the TBT Committee. Finally, in March 

2011, Vietnam published revised regulations removing the maximum aldehyde level for vodka 

as well. 

Despite this positive development, the United States remains concerned about certain aspects of 

Vietnam’s new requirements, including the product certification requirement, the frequency of 

testing, the process to obtain certificates, differences in certificate grades, and uncertainty 

regarding the applicability of the compliance certification stamp to various products. The 

United States will continue to press Vietnam to address remaining concerns with Vietnam’s 

regulations in 2011. 

Biotechnology – Mandatory Labeling

In June 2010, Vietnam adopted a new food safety law, which requires labeling for biotech food 

products and that may impede exports of U.S. food products to Vietnam. Vietnam clarified 

these requirements with several implementing regulations it adopted in 2010. As specified 

under these regulations, the labeling requirement will only apply to certain types of GM foods, 

although Vietnamese officials have yet to identify those categories. The United States is 

concerned that Vietnam’s labeling requirement, like other mandatory biotech labeling 

requirements, could increase consumer prices and product choices. Because Vietnam has not set 

a percentage or other threshold that will trigger its labeling requirement, it remains difficult to 

gauge the impact of the law on U.S. exports to Vietnam. The United States will continue to work 

closely with Vietnam on its biotech labeling law during 2011.

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XII. Appendix A: List of Commenters

Public comments received from:

1. Advanced Medical Technology Association

2. American Apparel and Footwear Association

3. Distilled Spirits Council of the United States

4. Grocery Manufacturers Association

5. Harley Davidson Motor Company

6. Herbalife International of America, Inc.

7. International Intellectual Property Alliance

8. National Association of Manufacturers

9. National Electrical Manufacturers Association

10. Pharmaceutical Research and Manufacturers of America

11. Telecommunications Industry Association

12. Toy Industry Association, Inc.

13. Underwriters Laboratories

14. Wine Institute

15. Yum! Restaurants International

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XIII. Appendix B: List of Frequently Used Abbreviations and Acronyms

ANSI .......................................................................... American National Standards Institute 

APA............................................................................ Administrative Procedure Act of 1946

APEC ......................................................................... Asia Pacific Economic Cooperation

EU .............................................................................. European Union

FSCF .......................................................................... Food Safety Cooperation Forum

FSCF PTIN ................................................................ Food Safety Cooperation Forum’s

.................................................................................... Partnership Training Institute Network

FTA............................................................................ Free Trade Agreement

GATT......................................................................... General Agreement on Tariffs and Trade

IAF ............................................................................. International Accreditation Forum

IEC.......................................................... International Electrotechnical Commission

ILAC ......................................................................... International Laboratory Accreditation

Cooperation

ISO ............................................................................. International Organization for

Standardization

MRA .......................................................................... Mutual Recognition Agreement

NAFTA ...................................................................... North American Free Trade Agreement

NAMA ....................................................................... Non-Agricultural Market Access

NEI............................................................................. National Export Initiative

NIST........................................................................... National Institute of Standards and

....................................................................................Technology 

NTTAA...................................................................... National Technology Transfer and 

.................................................................................... Advancement Act

NTB............................................................................ Non-Tariff Barrier

NTE............................................................................ National Trade Estimate Report on Foreign 

....................................................................................Trade Barriers

OECD......................................................................... Organization for Economic Cooperation 

....................................................................................and Development

OMB .......................................................................... Office of Management and Budget

SCSC ......................................................................... Subcommittee on Standards and 

.................................................................................... Conformance 

SDO............................................................................ Standards Developing Organization 

SME ........................................................................... Small and Medium Size Enterprise

SPS............................................................................. Sanitary and Phytosanitary Measures

TAA ........................................................................... Trade Agreements Act of 1979

TBT............................................................................ Technical Barriers to Trade

TEC............................................................................ United States – European Union 

.................................................................................... Transatlantic Economic Council

TFTF .......................................................................... Trade Facilitation Task Force

TIFA........................................................................... Trade and Investment Framework 

....................................................................................Agreement

TPP............................................................................. Trans-Pacific Partnership 

TPSC.......................................................................... Trade Policy Staff Committee
100

USDA......................................................................... U.S. Department of Agriculture

USITC........................................................................ U.S. International Trade Commission

USTR .........................................................................Office of the United States Trade 

Representative

WTO .......................................................................... World Trade Organization