2013 REPORT ON 

TECHNICAL BARRIERS 

TO TRADE

UNITED STATES TRADE REPRESENTATIVE
2013 Report on 

Technical Barriers to Trade 

Ambassador Demetrios Marantis

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. Acting U.S. Trade Representative Demetrios Marantis gratefully acknowledges 

contributions of 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. 

April 2013
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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 2012 ........................................................................................................6

Overview of Standards-Related Measures.........................................................................6

IV. Overview of Trade Obligations on Standards-Related Measures......................................9

WTO Agreement on Technical Barriers to Trade..............................................................9

Operation of the TBT Agreement ....................................................................................12

Standards-Related Provisions in U.S. Free Trade Agreements .......................................15

V. U.S. Statutory and Administrative Framework for Implementing StandardsRelated Trade Obligations ...............................................................................................19

VI. Standards..........................................................................................................................23

VII. Conformity Assessment Procedures ................................................................................27

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

How to Address Them .....................................................................................................29

Engagement in Voluntary Standards Activities...............................................................31

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

Bilateral Fora ...................................................................................................................33

Overview of U.S. Engagement on Standards-Related Measures.....................................33

WTO TBT Committee and Related Engagement ............................................................34

Specific Trade Concerns ......................................................................................34

Systemic Issues ....................................................................................................35

Total Economic Engagement Program ............................................................................35

Asia Pacific Economic Cooperation ................................................................................36

Good Regulatory Practices...................................................................................36
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Smart Grid............................................................................................................37

Green Buildings ...................................................................................................37

Solar Technologies...............................................................................................38

Information and Communication Technologies ..................................................38

APEC Food Safety Cooperation Forum (FSCF) and Partnership Training 

Institute Network (PTIN).....................................................................................38

Wine Regulatory Forum ......................................................................................39

Global Food Safety Partnership ...........................................................................39

Trans-Pacific Partnership.................................................................................................39

Free Trade Agreement – TBT Committee Meetings .......................................................40

Regulatory Cooperation Fora...........................................................................................40

Executive Order 13609.........................................................................................40

European Union....................................................................................................41

Mexico .................................................................................................................41

Canada..................................................................................................................42

North American Leaders Summit – Trilateral Regulatory Cooperation..............42

Doha Round Negotiations................................................................................................42

X. 2012-2013 Trends Regarding Standards-Related Measures............................................45

Nutritional Labeling and Advertising ..............................................................................45

EU Agreements on Conformity Assessment and Acceptance (ACAA)..........................45

Voluntary” Measures as Trade Barriers...........................................................................46

Mandatory Labeling of Foods Derived from Genetic Engineering .................................47

XI. Country Reports ...............................................................................................................49

Background on Specific Trade Concerns Contained in the Country Reports..................49

Argentina..........................................................................................................................49

Brazil................................................................................................................................50
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Chile.................................................................................................................................52

China ................................................................................................................................53

Colombia..........................................................................................................................60

The European Union ........................................................................................................61

India .................................................................................................................................65

Indonesia ..........................................................................................................................67

Japan ................................................................................................................................69

Kenya ...............................................................................................................................70

Korea................................................................................................................................70

Malaysia...........................................................................................................................73

Mexico .............................................................................................................................74

Russian Federation...........................................................................................................76

South Africa .....................................................................................................................79

Taiwan..............................................................................................................................79

Turkey..............................................................................................................................81

Vietnam............................................................................................................................82

XII. Appendix A: List of Commenters...................................................................................83

XIII. Appendix B: List of Frequently Used Abbreviations and Acronyms.............................85
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I. Foreword

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

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 key 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 small- and 

medium-sized enterprises (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 significantly advanced its efforts 

to resolve concerns with standards-related measures that act as unjustifiable barriers to trade and 

to prevent their emergence. USTR will continue its work to resolve and prevent trade concerns 

arising from standards-related measures inter alia through new and existing cooperative 

initiatives regarding standards-related issues in the World Trade Organization (WTO), AsiaPacific Economic Cooperation Forum (APEC), U.S. free trade agreements (FTAs), and other 

bilateral fora, as well as progress on the negotiation of a modernized Technical Barriers to Trade 

(TBT) chapter in the Trans-Pacific Partnership (TPP) that will build on and strengthen TBT 

disciplines contained in the WTO Agreement on Technical Barriers to Trade (TBT Agreement).

In addition, on February 13, 2013, President Obama and EU leaders announced that they would 

initiate the internal procedures necessary to launch negotiations on a comprehensive trade and 

investment agreement, the Transatlantic Trade and Investment Partnership. As conveyed in the 

February 2013 U.S.-EU High Level Working Group on Jobs and Growth (HLWG) Final Report, 

the United States and the EU are committed to working together to open markets in goods, 

services and investment, reduce non-tariff barriers, and address global trade issues of common 

concern. Both parties seek to build on the horizontal disciplines of the WTO TBT Agreement, 

establish ongoing mechanisms for improved dialogue and cooperation for addressing bilateral 

TBT issues, and pursue opportunities for greater regulatory compatibility with the objective of 

reducing costs stemming from regulatory differences in specific sectors.

Again in 2013, USTR will engage vigorously with other agencies of the U.S. Government, as 

well as interested stakeholders, to press for tangible progress by U.S. trading partners in 

removing unwarranted or overly burdensome technical barriers. We will fully utilize our toolkit 

of bilateral, regional and multilateral agreements and mechanisms in order to dismantle 

unjustifiable barriers to safe, high-quality U.S. industrial, consumer, and agricultural exports and 

strengthen the rules-based trading system. Recognizing that U.S. economic and employment 
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recovery and growth continue to rely importantly on the strength of U.S. exports of goods, 

services, and agricultural products, we will be redoubling our efforts to ensure that the technical 

barriers that inhibit those exports are steadily diminished. 

Ambassador Demetrios Marantis

Acting U.S. Trade Representative

April 2013
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II. Executive Summary

The 2013 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 and actions the United States is taking to address these 

barriers. These standards-related trade measures, which in World Trade Organization (WTO) 

terminology are known as “technical barriers to trade” (TBT) when they act as barriers to trade,

play a critical role in shaping the flow of global trade. 

Standards-related measures serve an important function in facilitating international trade, 

including by enabling small and medium-sized enterprises (SMEs) to obtain greater access to 

foreign markets. 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. Such measures can pose a particular 

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

own. 

This report describes and advances U.S. efforts to identify and eliminate standards-related 

measures that act as significant barrier to U.S. trade. The report consists of following key 

components:

x An introduction to standards-related measures, including the genesis of this 

report and the growing importance of standards-related measures in international 

trade (Section III);1

x 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);

x A description of the U.S. legal framework for implementing its standards-related 

trade obligations (Section V);

x A discussion of 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);

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

x An elaboration 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);

x A description of 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);

x An explanation of how the United States engages with its trading partners to 

address standards-related measures that act as barriers and prevent creation of 

new barriers 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 

Conformance, among others (Section IX);

x A summary of current trends regarding standards-related measures trends relating 

to standards-related measures (Section X); and

x An identification and description of significant standards-related trade barriers 

currently facing U.S. exporters, along with U.S. government initiatives to 

eliminate or reduce the impact of these barriers (Section XI) in 17countries –

Argentina, Brazil, China, Chile, Colombia, India, Indonesia, Japan, Kenya, 

Korea, Malaysia, Mexico, Russia, South Africa, Taiwan, Turkey, and Vietnam –

as well as the European Union (EU).
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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 

trade rules. The President vowed to pursue 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 has also recognized that non-tariff barriers have grown in significance for U.S. 

exporters seeking access to foreign markets. Two kinds of non-tariff measures pose a particular 

challenge to U.S. exports: sanitary and phytosanitary (SPS) measures and standards-related 

measures.

Accordingly, in 2009 U.S. Trade Representative Ambassador Kirk directed the Office of the 

U.S. Trade Representative (USTR) to create a new Report on Sanitary and Phytosanitary 

Measures (SPS Report) and a Report on Technical Barriers to Trade (TBT Report). He directed 

USTR staff to use these reports to promote understanding of the process of identifying non-tariff 

measures that act as significant barriers to U.S. exports; to provide a central focus for 

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.

The TBT Report is a specialized report addressing significant foreign barriers in the form of 

product standards, technical regulations, and conformity assessment procedures (standardsrelated measures). Prior to 2010, the National Trade Estimate Report on Foreign Trade 

Barriers (NTE Report) addressed standards-related measures. 2 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 (2013 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

imposed or under consideration by certain U.S. trading partners. 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 

2 In accordance with section 181 of the Trade Act of 1974 (the 1974 Trade Act) (codified at 19 U.S.C. § 2241), 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.
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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 notice published in the Federal Register, 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 2012

During 2012, the United States succeeded in persuading its trading partners to reduce or 

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

States also continued to intensify its efforts to help other governments to avoid imposing 

unwarranted standards-related barriers to trade, particularly with respect to innovative 

technologies and new areas of regulation, and to strengthen their capacity to regulate properly 

and to promote good regulatory practices. In 2012, the United States also proposed new 

initiatives in key trade and economic forums, including in the WTO and the Asia-Pacific 

Economic Cooperation Forum (APEC), as well as in negotiations to conclude a Trans-Pacific 

Partnership (TPP) agreement, to encourage governments to eliminate and prevent unwarranted 

standards-related barriers to trade.

Overview of Standards-Related Measures

Today, standards-related measures (standards, technical regulations, and conformity assessment 

procedures) play a critical role in shaping the flow of international trade. While tariffs still 

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

shaping international 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 1947). With these declines in tariffs, the role of non-tariff barriers in international trade 

has become more prominent.

Broadly speaking, standards-related measures are documents and procedures that set out specific 

technical or other requirements for products or processes as well as procedures to ensure that 

these requirements are met. Among other things standards-related measures help:

x ensure the connectivity and compatibility of inputs sourced in different markets; 

x manage the flow of product-related information through complex and 

increasingly global supply chains;
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x organize manufacturing or other production processes around replicable routines 

and procedures to yield greater product quality assurance;

x achieve important regulatory and societal objectives, such as ensuring product 

safety, preventing deceptive practices, and protecting the environment; and 

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

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

information to producers and consumers about the characteristics or performance of components 

and end products they purchase 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. Uniform standards and product 

testing procedures established under a common set of technical requirements that producers can 

rely on in manufacturing components and end products, can facilitate the diffusion of 

technology and innovation, contribute to increasing buyer-seller confidence, and assist SMEs to 

participate in global supply chains. 

Conversely, outdated, overly burdensome, discriminatory, or otherwise inappropriate standardsrelated measures 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. 

Thus, while standards-related measures can be an effective and efficient means of achieving 

legitimate commercial and policy objectives, policy makers, industry officials, and other 

stakeholders must also confront an important question: how to 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 as a 

means to facilitate the flow of goods across borders, reduce costs associated with complying 

with different standards and technical regulations across jurisdictions and markets, and enhance 

governments’ ability to achieve important public policy objectives.

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 

additional rules with respect to 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 IV 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 
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government policy deliberations on these measures through the interagency Trade Policy Staff 

Committee (TPSC). 3 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.

3 http://www.ustr.gov/about-us/executive-branch-agencies-trade-policy-staff-committee-and-trade-policy-reviewgroup
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IV. Overview of Trade Obligations on Standards-Related Measures

WTO Agreement on Technical Barriers to Trade

The WTO Agreement on Technical Barriers to Trade (TBT Agreement) contains rules that help

ensure that standards-related measures serve legitimate objectives, are transparent, and do not 

create unnecessary obstacles to trade.4 The TBT Agreement establishes rules on developing, 

adopting, and applying voluntary product standards and mandatory technical regulations as well 

as 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 

standards-related 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 prepare, adopt, and apply

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 obligations 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 contains a Code of Good Practice for the Preparation, Adoption, and Application of 

Standards (Code). The Code applies to the preparation, adoption, and application of voluntary 

standards and is open to acceptance by any standardizing body located in the territory of any 

WTO Member, including government and non-governmental bodies. Box 2 outlines the key 

disciplines of the TBT Agreement.

Box 2. Key principles and provisions of the TBT Agreement

Non-discrimination: The TBT 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 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 to the applicable 

requirements. (Art. 5.1.2)

4 http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm
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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 

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 promoting better alignment of technical regulations,

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 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 directs 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 final 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 respect to 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 
11

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)

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.

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 the Member’s proposed or existing measures and provides relevant 

documents, as appropriate. It also requires each WTO Member to ensure that all standardsrelated measures that it adopts are promptly published or otherwise made publicly available.

The TBT Agreement requires each WTO Member 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.5 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.6 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.7 In 2012 alone, 

WTO Members notified 1,550 new or revised technical regulations and conformity assessment 

5 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.

6 WTO 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.

7 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.
12

procedures, as well as submitted 575 addenda and 45 corrigenda to previous notifications. Since 

entry into force of the Marrakesh Agreement Establishing the World Trade Organization (WTO 

Agreement)8 on January 1, 1995, up to December 31, 2012, 15,736 notifications along with

2,684 addenda and 485 corrigenda to these notifications have been made by 116 members. Box 

3 shows the number of notifications yearly since 1995.9

Box 3. Number of TBT Notifications since 199510

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 159 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 sets out rules covering complex requirements developed and implemented 

by disparate bodies (central and local governmental agencies; inter-governmental 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 nongovernmental bodies, such as private sector standards developing organizations, comply with

8 The TBT Agreement is one of several agreements, understandings and decisions comprising the WTO Agreement.

9 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. 

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

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

10 Number of TBT Notifications since 1995 found in “Eighteenth Annual Review of the Implementation and 

Operation of the TBT Agreement (G/TBT/33).”

0

500

1000

1500

2000

2500

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Notifications Addenda/Corrigenda
13

the relevant provisions. Further, each WTO Member must inform the TBT Committee of the 

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

Agreement.11

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. Sound mechanisms for internal coordination among a WTO 

Member’s trade, regulatory, and standards officials are critical to ensuring that 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 reduce any adverse 

effects on trade while still fulfilling the measure’s objective.

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

in foreign markets, it can actually make the measures they adopt more effective in fulfilling their

objectives. 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. 

Accordingly, 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.

The TBT Committee conducts triennial reviews of systemic issues affecting WTO Members’ 

policies and procedures for implementing specific obligations.12 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. In recent years, Committee events 

have covered good regulatory practice, conformity assessment, transparency, the role of 

international standards in development, and regulatory cooperation.

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

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

trade concern regarding standards-related measures that other WTO 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 2012, WTO Members raised over 94

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 nonsafety 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 

11 See G/TBT/GEN/1/Rev.11 for a list of Members’ submissions on the measures they have taken to implement and 

administer the TBT Agreement. 

12 The Committee’s work on the outcome of the most recent triennial review is discussed in Section IX.
14

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.13

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

Committee since 1995. The general increase 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/31.

Box 4. Number of specific trade concerns raised per year14

In recent years, the Committee has implemented procedures to streamline the discussion of 

specific trade concerns during its meetings and avoid unnecessary repetition. While addressing 

specific trade concerns is core to the Committee’s responsibility in monitoring how well WTO 

Members are implementing the TBT Agreement, some exchanges on unresolved issues have 

become protracted, leaving less time for the Committee to address the cross-cutting or systemic 

13 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 Number of specific trade concerns raised since 1995, found in “Eighteenth Annual Review of the Implementation 

and Operation of the TBT Agreement (G/TBT/33).”

3 6 4 7 12 12 13 12 12

19

26 28 32 32

59

4 6 11

13 5 13

15

20 15 14 12

24

27

32

46

29

44

35

4 6

11

16

11

17

22

32

27 27

24

36

46

58

75

61

76

94

0

10

20

30

40

50

60

70

80

90

100

New concerns Previous Concerns
15

issues needed to prevent and resolve trade issues. In 2012, the Committee agreed to use 

informal “thematic” discussions on the margins of its meetings in 2013, in order to sharpen 

focus and make progress on key systemic issues. In 2013, the Committee held thematic 

discussions on standards and good regulatory practices in March and will hold thematic 

discussions on Transparency and Inquiry Point operations in June and conformity assessment in 

November.

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

In U.S. FTAs, the parties reaffirm their commitment to the TBT Agreement. 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 standards-related measures in its FTAs is commonly referred to 

as “TBT plus.”15 For example, recent FTAs require each party to allow persons of the other 

Party to participate in the development of standards, technical regulations and conformity 

assessment procedures. Moreover, each party is required to permit persons of the other party to 

participate in the development of these measures on terms no less favorable than it accords its 

own persons. 

U.S. FTAs also contain a variety of other 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 processes, 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.16 The provisions in U.S. FTAs that provide for more 

timely and robust consultations and participation, enhance the notifications process, and provide 

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

These consultative mechanisms can provide a channel for peer-to-peer capacity building 

activities with FTA partners whose standards and conformance processes may be

underdeveloped or otherwise in need of improvement.

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

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

16 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.
16

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

environment. At the same time, U.S. FTAs provide mechanisms through which FTA partners 

can reduce the negative effects on their bilateral trade stemming from unnecessary differences in 

their 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.17 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 VI below.

In 2012, the United States made significant progress with ten Asia Pacific trading partners 

through the Trans-Pacific Partnership (TPP) negotiations towards concluding a TBT chapter and 

several sectoral annexes addressing standards-related measures. Further details on the TPP are 

provided in Section IX below.

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 

FTAs 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,

Colombia, Korea, Morocco, Oman, Panama, and Peru. 

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 expand upon transparency obligations provided for in the TBT Agreement. For example, 

US FTAs with Colombia, Peru and Korea provide 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 and require parties (1) to notify proposed technical regulations even where those regulations are based 

on relevant international standards; (2) to notify proposals for technical regulations or conformity assessment 

procedures directly to the other Party; (3) to include in notifications of proposed technical regulations and 

conformity assessment procedures the objectives of the proposed measure and the proposed measure’s rationale or 

how the measure meets those objectives; (4) to provide interested parties as well as the FTA partner a meaningful 

opportunity to comment on the proposed measure; (5) to allow at least 60 days for comment; (6) to provide 

responses to significant comments received no later than the time a final measure is published; and (7) to provide 

17 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.10.
17

additional information about the objectives when requested.

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

and conformity assessment procedures. They also urge parties 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.

19

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).18 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 regarding standards-related activities, as well as in 

discussions and negotiations with foreign governments 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. 19 In accordance with the APA, agencies publish 

proposed technical regulations and conformity assessment procedures in the Federal Register

and solicit comments from the public through notices published 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 and inquiry point for purposes of the TBT 

Agreement. The U.S. inquiry point reviews the Federal Register and other materials on a daily 

basis and notifies the WTO of technical regulations and conformity assessment procedures that 

agencies propose to adopt. 

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

II, Technical Barriers to Trade (Standards).

19 The 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). 
20

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 regulatory philosophy, principles, and 

actions that 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, 20 such as that 

embodied in E.O. 12866 and 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 set 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 (E.O. 13563), which reaffirms and supplements 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.

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

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.
21

On May 12, 2012, President Obama issued Executive Order 13610 - Identifying and Reducing 

Regulatory Burdens (E.O. 13610), which requires agencies to conduct retrospective analyses of 

existing rules to examine whether they remain justified and whether they should be modified or 

streamlined in light of changed circumstances, including the emergence of new technologies.

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 use 21 voluntary consensus standards 22 in their 

regulatory activities wherever possible and to avoid using “government-unique” standards.23

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

suitable voluntary consensus standards already exist. OMB will revise A-119, and will seek 

comments from the public on the changes in 2013.

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 VI, 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. In 2012, APEC published two related studies. The first 

study, “Good Regulatory Practices in APEC Member Economies - Baseline Study,” reviews the 

application of selected GRPs across the 21 APEC members. The report focuses on several 

procedures that promote good regulatory practices particularly important to trade and investment 

such as accountability, consultation, efficiency, and transparency. The second study,

“Supporting the TBT Agreement with Good Regulatory Practices,” explores the relationship 

between TBT obligations and current GRPs used around the world. These recommended GRPs 

demonstrate choices available to WTO Members for implementation of practices that support 

trade-friendly regulation and implementation of their WTO commitments.

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

22 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. 

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

uses.

23

VI. Standards

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

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

Agreement defines “standard” as:

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 competition24 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 objectives 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.25

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. The TBT Agreement also 

strongly discourages standardizing bodies from developing standards where international 

standards already exist.

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 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.26 The 2000 

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

Through Effective Collaboration, International Trade Administration, 2005, available at 

http://www.trade.gov/td/standards/pdf%20files/Standards%20and%20Competitiveness.pdf.

25 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. 

26 Decision on Principles for the Development of International Standards, Guides and Recommendations with 
24

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 

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. 27 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.

28 WTO Members’ central 

government standardizing bodies are required to comply with the Code, and WTO Members are 

required to take reasonable measures to ensure that local government bodies and nongovernmental 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.

29 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 principles contained in 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.

Relation to Articles 2, 5 and Annex 3 of the TBT Agreement are contained in document G/TBT/1/Rev.10.

27 The U.S. experience with the 2000 Committee Decision is described in G/TBT/W/305.

28 Available at http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm

29 Available at http://www.ansi.org/standards_activities/nss/usss.aspx.
25

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

of voluntary standards.30 Circular A-119 directs Federal agencies to use voluntary consensus 

standards in lieu of government-unique standards except where inconsistent with law or 

otherwise impractical. The Circular also provides guidance for Federal agencies participating in 

voluntary consensus standards bodies. 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 organizations31

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 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.

30 Available at http://www.whitehouse.gov/omb/circulars_a119/.

31 Source: NIST, 2008.

27

VII. Conformity Assessment Procedures

The TBT Agreement defines “conformity assessment procedures” as: “Any procedure used, 

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

standards are fulfilled.” Outside the TBT Agreement, conformity assessment procedures may 

also encompass a broader set of procedures, for example, good manufacturing practices that are 

not related to product characteristics.

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

that products sourced in domestic and foreign markets meet specific requirements. 32

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.33

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.34 Indeed, 

many specific trade concerns that the United States has raised 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.10.

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 published a notice in the Federal Register

32 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.

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

Assessment System, NIST, 1997. 

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

Measures, U.S. International Trade Commission Working Paper, 2008.
28

in 2000 providing guidance to Federal agencies on conformity assessment.

35 This notice 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 conformity assessment standards and guides published by ISO and IEC 

are known as the “CASCO toolbox.”36

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.

37 The 

TBT Agreement, NIST’s guidance, and ANSI’s principles all emphasize the importance of the 

development and use of international conformity assessment standards and participation in 

international accreditation systems 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. U.S. 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.

35 http://gsi.nist.gov/global/docs/FR_FedGuidanceCA.pdf

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

37 http://publicaa.ansi.org/sites/apdl/Documents/News%20and%20Publications/Brochures/NCAP%20second%20edi

tion.pdf
29

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

Determining How to Address Them

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

from the Departments of Agriculture, Commerce, and State – 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 U.S. 

TBT Inquiry Point and Notification Authority (U.S. 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 Agreements and Scientific Affairs (OASA) 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 of standardsrelated measures, the U.S. Inquiry Point 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. 38 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 so provide, or through the U.S. Inquiry Point,

which works with relevant Federal agencies to review, compile and submit comments to the 

WTO Member. By providing comments through the U.S. Inquiry Point, U.S. stakeholders alert 

Federal agencies to their concerns and enable advocacy by Federal agencies on their behalf.

In 2012, the U.S. TBT Inquiry Point distributed 2,176 WTO TBT notifications to registered 

stakeholders, including 248 U.S. notifications. The U.S. TBT Inquiry Point processed 450 

requests for information on standards and technical regulations and fulfilled 728 requests for 

full-text documents associated with TBT notifications. The U.S. TBT Inquiry Point distributed 

38 Available at https://tsapps.nist.gov/notifyus/data/index/index.cfm
30

190 U.S. Government and industry comments to other WTO Members and circulated 26 WTO 

Member comments on U.S. measures, as well as 27 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 Notify U.S. (which added more than 400 

new subscribers in 2012), and 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. The U.S TBT Inquiry Point hosted or participated in training for 

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

operates.

Through the Trade Agreements Compliance (TAC) Program, the U.S. Department of Commerce 

supports the enforcement prong of the National Export Initiative (NEI) by coordinating 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 TAC Program includes an online trade complaint hotline at www.export.gov/tcc,

where exporters can report and obtain assistance in overcoming foreign trade barriers. As part 

of the TAC Program, the Department of Commerce assembles teams of specialists to investigate 

market access problems, including those involving standards-related measures, as well as to 

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

or improve market access.

In addition, the Department of Commerce regularly provides input to the TPSC and TPSC 

Subcommittee based on the information on the specific trade concerns that it collects and 

analyzes through the TAC Program. This 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-the-ground assistance at U.S. embassies in 

China, India, El Salvador, and at the U.S. Mission to the European Union in Brussels. Free, 

online tools include the texts of more than 250 non-agricultural trade agreements plus a 

checklist of the kinds of trade barriers that the TAC Program can help exporters overcome.

The Department of Agriculture’s OASA provides a conduit for queries and comments on 

foreign standards-related measures in the agricultural sector. OASA monitors developments in 

relevant export markets, provides information on foreign standards-related measures through a 

range of publications, disseminates TBT notifications from foreign governments to interested 

parties, and provides translation services on key export market requirements. OASA 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 standardsrelated measures. In addition, the Department of Agriculture’s FAS overseas offices maintain 

country-specific reporting and alerts that highlight foreign commodity-specific import 

requirements. These officers assist with detained shipments and help to identify innovative 

solutions to keep trade flowing. FAS also participates in numerous relevant international 

organizations, such as Codex Alimentarius, to proactively address agriculture-related trade 

concerns 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 (ITACs and ATACs, respectively).

The ITACs and the ATACs help identify trade barriers and provide assessments regarding the 
31

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.39

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.

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.

Engagement in Voluntary Standards Activities

In the United States, standards development is led by the private sector and highly informed by 

market needs. However, in limited circumstances, in areas relevant to their agency objectives, 

Federal government agencies also actively engage or play a convening role in standards 

development. In January 2012, USTR, OIRA, and OSTP released a joint memorandum to 

agencies entitled “Principles for Federal Engagement in Standards Activities to Address 

National Priorities”40 to clarify principles guiding Federal agencies’ engagement in standards 

activities. The memorandum emphasizes the strengths of the U.S. standards model of private 

sector leadership but notes that where a national priority has been identified in statute, regulation, 

or Administration policy, active engagement or a convening role by the Federal Government 

may be needed to accelerate standards development and implementation to spur technological 

advances, promote market-based innovation, and encourage more competitive market outcomes. 

The memorandum establishes five “fundamental strategic objectives” for Federal Government 

engagement in standards activities:

x produce timely, effective standards and efficient conformity assessment schemes 

that are essential to addressing an identified need;

x achieve cost-efficient, timely, and effective solutions to legitimate regulatory, 

procurement, and policy objectives;

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

40 Available at http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08.pdf.
32

x promote standards and standardization systems that promote and sustain 

innovation and foster competition; 

x enhance U.S. growth and competitiveness and ensure non-discrimination, 

consistent with international obligations; and 

x facilitate international trade and avoid the creation of unnecessary obstacles to 

trade.
33

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 pursues a broad agenda and active 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 standards-related trade concerns. In addition, U.S. agencies seek to 

prevent potential standards-related trade 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 other countries can assist

firms in complying with standards-related measures. As producers increase their participation in 

global supply chains, they need a better understanding of technical requirements of countries, 

including the United States, and strategies to meet those requirements consistently. 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), the Commerce Department’s 

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

(MDCP), and NIST’s Standards in Trade Program. 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 mutual recognition 

agreements (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.
34

NIST maintains a complete inventory of the government-to-government MRAs to which the 

United States is a party. 41 It also maintains a listing of the accreditation requirements for 

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.)42

The United States also seeks to reduce foreign technical barriers to trade by concluding 

equivalency arrangements with other governments. In 2009, the United States exchanged the 

first equivalency determination with Canada on organic agricultural products. On February 15, 

2012, the United States signed a second organics equivalence arrangement with the European 

Union. 

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 XI.

WTO TBT Committee and Related Engagement

As noted above, the U.S. Government actively seeks to prevent and eliminate unnecessary 

technical barriers to trade through the focused WTO Member-driven agenda of the WTO TBT 

Committee (“TBT Committee”). 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. 

Specific Trade Concerns

In 2012, the United States raised specific trade concerns regarding on average 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 XI of this report. As elaborated in Section XI, 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 and identifies the Members that raised them. 

41 Available at http://gsi.nist.gov/global/index.cfm/L1-4/L2-16.

42 Available at http://transition.fcc.gov/oet/ea/mra/.
35

Systemic Issues

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.10, which are intended to strengthen and improve the operation of the TBT 

Agreement. Each triennial review also results in a report on the systemic issues the Committee 

discussed, along with a work plan to explore ways in which WTO Members can more 

effectively implement their TBT obligations.

In November 2011, the TBT Committee initiated its Sixth Triennial Review of the Operation 

and Implementation of the Agreement on Technical Barriers to Trade under Article 15.4. In the 

review, which concluded in November 2012, the Committee agreed to exchanges of information 

on (1) voluntary mechanisms and related principles of Good Regulatory Practices to guide 

members in efficient and effective implementation of the TBT Agreement; (2) approaches to, 

recognition of, and use of international standards for conformity assessment; (3) implementation

of the Code of Good Practice by local governments and non-governmental bodies; and (4) the 

six principles of international standards development set out in the 2000 Committee Decision,

with particular focus on the development dimension and transparency.

The United States also launched a new U.S.-sponsored assistance facility called the “Standards 

Alliance” to help build capacity among developing countries to implement the TBT Agreement.

The new Standards Alliance will help developing countries strengthen implementation of the 

TBT Agreement, including by improving their notification practices, by improving domestic 

practices related to adopting relevant international standards, and in clarifying and streamlining 

their regulatory processes for products. This program aims to reduce the costs and bureaucratic 

hurdles U.S. exporters face in foreign markets, and increase the competitiveness of American 

products, particularly in developing markets.

From October 30 through November 1, 2012, the U.S. Inquiry Point, in partnership with its 

Brazilian partner INMETRO and Standards Council Canada, hosted the first ever Inquiry Point 

of the Americas conference in Rio de Janeiro. The conference, a product of the U.S.-Brazil 

Commercial Dialogue, brought together nearly 200 TBT experts from thirty Western 

Hemisphere countries and the WTO in a workshop to exchange best practices regarding 

implementing transparency provisions of the WTO TBT Agreement and working with the 

private sector to improve the use of this valuable tool. 

Total Economic Engagement Program

The Department of Commerce’s Total Economic Engagement (TEE) Program provides 

technical assistance and capacity building to advance a more collaborative and open process to 

foster greater regulatory harmonization and convergence. TEE works with foreign governments, 

trade associations, and standards setting bodies on key public-private partnerships.

For example, in 2012, the TEE program sought to improve market access for U.S. certification 

bodies in China’s compulsory certification (or CCC mark) testing regime. Through this 

program the Commerce Department urged China's Certification and Accreditation 
36

Administration (CNCA) and China’s Quality Certification Centre (CQC) to increase 

transparency, foster more predictable administrative processes, and develop more appropriately 

designed verification procedures for China’s CCC program in accord with China’s WTO 

commitments.

With the Russian Federation’s recent membership in the WTO, Russia offers U.S. producers and 

exporters a potentially significant export market for high-quality products. To assist Russia in 

meeting its WTO commitments, the Commerce TEE program is conducting a series of outreach 

events across the United States and Russia to raise awareness of the new trade opportunities that 

will be afforded to U.S. companies.

Asia Pacific Economic Cooperation

APEC is the Asia-Pacific region’s premiere inter-governmental economic organization. Its core 

mission is to strengthen regional economic integration by addressing barriers to trade and 

investment. APEC’s twenty-one 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 the top 15 trade partners of the United States are members of 

APEC. In 2012, APEC focused on four areas: trade and investment liberalization and regional 

economic integration; strengthening food security; establishing reliable supply chains; and 

intensive cooperation to foster innovative growth.

As part of these efforts, the United States furthered work to prevent and eliminate unnecessary 

technical barriers related to emerging green technologies, such as those related to commercial 

green buildings and Smart Grid technology. 43 Additionally, the United States encouraged

APEC economies to adopt standards and conformity assessment procedures that promote 

greener growth through the alignment of energy efficiency standards and conformity assessment

procedures for information and communication technology (ICT) products. The areas of focus 

for 2012 with respect to green technologies included regional economic integration, product 

safety, supply chain integrity, and environmental protection. These green technology efforts

with respect to Smart Grid, green buildings, and solar and ICT technologies, are further 

elaborated below. The United States also worked with APEC to advance regulatory cooperation 

dialogues regarding food and wine. APEC economies further recognized the importance of

good regulatory practices and addressing unnecessary technical barriers to trade by advancing 

regulatory convergence and coherence.

Good Regulatory Practices

In 2012, APEC economies also re-affirmed their 2011 commitment to strengthen 

implementation of good regulatory practices, including through capacity building. In 2013, the 

United States will advance Good Regulatory Practices by updating the 2011 APEC Baseline 

43 The U.S. Department of Energy defines Smart Grid as an electrical grid that uses information and 

communications technology to gather and act on information, such as information about the behaviors of suppliers 

and consumers, in an automated fashion to improve the efficiency, reliability, economics, and sustainability of the 

production and distribution of electricity.
37

Study on member practices, developing a self-funded study on good regulatory practices with 

respect to conformity assessment, and participating in the 7th APEC Conference on Good 

Regulatory Practice, to be held in Medan, Sumatra in June 2013.

Smart Grid

Building on the success of the intensive dialogue and suggested trade-related principles on 

Smart Grid interoperability standards developed through the 2011 APEC Regulatory 

Cooperation Advancement Mechanism (ARCAM), the United States conducted a second 

workshop for energy regulators, entitled, “Regulatory Approaches to Smart Grid Investment and 

Deployment,” on the margins of the World Forum on Energy Regulation held on May 16-17, 

2012, in Quebec City, Canada. The conference sought to facilitate collaboration and 

information sharing between key stakeholder groups involved in the development of Smart Grid

interoperability standards. The workshop responds to the APEC Committee on Trade and 

Investment (CTI) call for APEC economies to “implement mechanisms for internal coordination 

within APEC member economies among regulatory authorities, standards developing bodies and 

trade officials to advance interoperability of Smart Grid requirements.”

The workshop recommended that regulators and standardization bodies continue and enhance 

discussion of developments and experiences regarding implementation of Smart Grid programs.

Green Buildings

Green buildings provide opportunities for U.S. companies to export a wide range of “green” 

products in which they have a competitive advantage, such as products related to plumbing, 

lighting, flooring, HVAC systems, and fixtures. The world imported $70 billion in U.S. 

building products in 2009, with APEC economies accounting for fully 70 percent of this total 

($50 billion). 

In addition, greening the commercial building sector can also yield significant energy savings, 

given that the sector accounts for between 30 and 40 percent of energy usage in most 

industrialized economies. These energy savings contribute to meeting greenhouse gas emissions 

targets, and improve energy security.

To advance these objectives, the United States supported two APEC studies on the subject of 

green buildings. The first study addressed green building rating systems in APEC economies. 

The second study addressed the trade impact of life cycle analysis for flooring materials and 

plumbing fixtures.

APEC Support Fund (ASF) has awarded the U.S. Department of Commerce $830,000 to serve 

as the project sponsor of a new APEC multi-year project on the relationship between standards 

and conformity assessment and energy efficient performance in commercial buildings. The 

project consists of a series of interrelated workshops and data gathering, which will occur from 

2013-2015. These workshops and data gathering activities will aim to build the capacity of 

APEC economies to implement green building measures that are consistent, transparent, and 

appropriate, thus avoid creating unnecessary obstacles to trade. In 2013, Peru and the United 

States are working together to organize a workshop on “Sharing Experiences in the Design and 

Implementation of Green Building Codes” (March 2013). For this workshop, the United States 

will present a study on the use of building codes and green codes in the Asia Pacific region. The 
38

other workshop topics in the series include: Building Information Modeling (BIM) (June 2013); 

best practices in the testing and rating of products in the building envelope; and mapping of 

building product testing requirements. The United States is working together with the ASEAN 

Consultative Committee on Standards and Quality (ACCSQ) on these workshops.

Solar Technologies

The United States plans to introduce a project on solar technology and Smart Grid integration in 

2013-2014. The goal of this project is to identify common goals, best practices, and strategies 

among APEC member economies that can facilitate Smart Grid and solar technology 

deployment as well as trade.

Information and Communication Technologies

Following the first successful dialogue in APEC on Information and Communication 

Technology (ICT) Energy Efficiency Standards, the United States organized a second workshop 

on the same subject in Seoul, Korea on July 18, 2012. Building on agreed principles from the 

first workshop, participants discussed the adoption and application of the ECMA383/IEC62623 

standard.44

In 2013, the United States will suggest that APEC form a limited term working group of 

regulators to facilitate transition of personal computer energy efficiency programs to the new 

international standard. 

APEC Food Safety Cooperation Forum (FSCF) and Partnership Training Institute Network 

(PTIN)

Trade in food and agricultural products in the Asia Pacific is vital to U.S. interests, yet concerns 

about food safety in the region spiked in recent years following a series of high-profile food 

safety incidents. These prompted APEC economies to agree to strengthen food safety standards 

and practices in the region and encourage adherence to international science-based standards to 

facilitate trade in the region and enhance food safety. In response, the APEC Subcommittee on 

Standards and Conformance (SCSC) established the Food Safety Cooperation Forum (FSCF) in 

2007 with the goal of improving food safety regulatory systems in APEC economies in line with 

WTO Members’ rights and obligations under both the SPS and TBT Agreements. In 2008, 

APEC economies called for increased capacity building to improve technical competence and 

understanding of food safety management among stakeholders in the food supply chain through 

the public-private partnership initiative, the Partnership Training Institute Network (PTIN).

Since 2007, over $4 million of public and private sector funds have been contributed for FSCF 

and PTIN activities. The FSCF and PTIN have identified priority capacity building needs and 

delivered over 30 programs in key areas (supply chain management, food safety incident 

management, laboratory competency, risk analysis, food safety regulatory systems) since their 

inception.

44 ECMA383/IEC 62623:2012 covers personal computing products. It applies to desktop and notebook computers. 

This standard specifies a test procedure to enable the measurement of the power and energy consumption.
39

In 2012, the U.S. convened experts from the public and private sectors to develop a strategy to 

improve laboratory capacity in the APEC region. Funding for two to three pilot projects may be 

available for 2013. This work builds on previous PTIN efforts on laboratory capacity building,

including three U.S.-led training sessions in 2012 on laboratory practices. In addition, the PTIN 

developed a supply chain management training module, which is now freely available on the 

PTIN website.

APEC awarded the United States $1.8 million to serve as the project sponsor for an APEC 

multi-year project: Building Convergence in Food Safety Standards and Regulatory Systems for 

2013-2015 encompassing priorities that include food safety standards and best practices for 

small- and medium-sized enterprise, incident management, laboratory capacity, food inspection 

based on risk analysis, and proficiency testing. FSCF and PTIN Steering Group meetings are 

scheduled to occur in April 2013 at the second APEC Senior Officials Meeting (SOM 2) in 2013

to address a first suite of activities relate to these priorities.

Lastly, the PTIN continued to work closely with the World Bank through the newly established 

Global Food Safety Partnership (GFSP), including developing a three-year plan of coordinated 

activities on food safety with the GFSP.

Wine Regulatory Forum

In 2008, the SCSC created a Wine Regulatory Forum (WRF) to promote trade-facilitating 

regulation of wine. Wine exports are critically important to several APEC economies, with their 

wine product export market totaling $3.6 billion in 2010. Following the success of the first-ever 

regional meeting of wine regulators and industry representatives in 2011, New Zealand hosted 

the second meeting of the APEC WRF. On November 5-6, 2012, the APEC Wine Regulators 

Forum meeting entitled, “Risk Management & Certification in Wine Trade: Public-Private 

Dialogue,” was held in Auckland, New Zealand. This was a follow-up to the highly successful 

meeting in San Francisco, in September 2011. The key themes of the meeting were risk 

management and certification in the APEC wine trade. Participants exchanged views on the 

issues of wine as a low food safety risk product and multiple certification requirements. In 2013, 

the United States has proposed a multi-year project, which includes a pilot for electronic 

certificates for wine.

Global Food Safety Partnership

In 2012, the United States and the food industry contributed an initial $1 million in start-up

funds to launch the World Bank GFSP. The objective of the GFSP is to improve food safety 

systems. The GFSP is undertaking a five-year program for training and capacity building in 

food safety. GFSP held a training program on food safety prerequisites and hazard analysis and 

critical control points (HACCP) in Beijing in June 2012 and will expand this program in 2013. 

A HACCP aquaculture module will be ready by April 2013. An assessment of laboratory 

capacity in the APEC economies is also under way. Other initial training programs will be 

supported by a $1.8 million APEC funding commitment for 2013-2015.

Trans-Pacific Partnership

In November 2009, President Obama announced that the United States would participate in 

negotiations to conclude a comprehensive Asia-Pacific trade agreement: The Trans-Pacific 
40

Partnership (TPP) Agreement. Through the TPP, the United States seeks to advance U.S. trade 

and investment opportunities in the Asia-Pacific by negotiating an ambitious, 21st century 

regional trade agreement. The TPP negotiations began with an initial group of countries 

comprising: Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore, the 

United States, and Vietnam. In October 2012, Canada and Mexico joined the negotiations and 

participated in the round of negotiations held in Auckland, New Zealand in December 2012.

On standards-related measures, the United States is emphasizing several key issues, including 

regulatory transparency, the use of GRPs, and the acceptance of the results of conformity 

assessment procedures carried out in TPP 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 standards-related measures that act as barriers to trade.

In 2012, the TPP Working Group on Technical Barriers to Trade (TBT) made substantial 

progress to advance negotiations of the TBT chapter, including several sector-specific annexes.

The TBT chapter includes obligations that build upon the WTO TBT Agreement (referred to as 

“TBT plus”), including obligations on transparency, conformity assessment and international 

standards, and sets a framework for addressing trade concerns and for advancing cooperative 

activities on standards-related measures. These obligations seek to prevent and reduce 

unnecessary costs and barriers to trade in the region. The sector-specific annexes include 

obligations regarding the development and implementation of standards-related measures to 

address unnecessary barriers to trade in products in specific sectors, such as cosmetics, 

pharmaceuticals, medical devices, information and communications technology products, wine 

and spirits, and food formulas.

In 2013, the TBT Working Group will press to conclude the TBT chapter and its annexes.

Free Trade Agreement – TBT Committee Meetings

The inaugural meeting of the United States-Colombia Trade Promotion Agreement’s Committee 

on Technical Barriers to Trade (TBT Committee) was held in Washington, DC, on October 23-

24, 2012. The two governments discussed their respective systems as well as particular issues

such as biologics, diesel emissions, baby clothing, food safety standards, appliances, and 

cosmetics. The Colombian delegation also visited NIST for training on Inquiry Point operations.

Other FTA TBT Chapter meetings that were held in 2012 included the TBT Chapter meeting 

under the United States-Chile FTA in November 2012, and two meetings of the NAFTA 

Committee on Standards Related Measures in February and October.

Regulatory Cooperation Fora

Executive Order 13609

On May 1, 2012, President Barack Obama signed Executive Order (E.O.) 13609 entitled 

“Promoting International Regulatory Cooperation” to help reduce, eliminate, and prevent 

unnecessary differences in regulatory requirements imposed by U.S. and foreign regulators, which 

can limit the ability of American businesses to export and compete internationally. The E.O. calls 

for the Regulatory Working Group established by E.O. 12866, and reaffirmed by E.O. 13563, to 

serve as a forum to discuss, coordinate, and develop a common understanding among agencies of 
41

U.S. Government positions and priorities with respect to: international regulatory cooperation 

activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the 

Federal Government to support significant, cross-cutting international regulatory cooperation 

activities; and promotion of good regulatory practices internationally, as well as the promotion of 

U.S. regulatory approaches, as appropriate.

USTR continues to lead on the coordination and development of standards-related trade policies.

The United States participates in three bilateral regulatory cooperation forums aimed at promoting 

regulatory best practices and aligning regulatory approaches in economically significant sectors

with the European Union, Canada, and Mexico.

European Union

The EU’s approach to standards-related measures (as described in the 2012 TBT Report), and its 

efforts to encourage governments around the world to adopt its approach, presents a strategic 

challenge for the United States in the area of standards-related measures. In 2013, U.S. officials 

will continue to encourage systemic changes in the EU approach in existing bilateral fora, such 

as the Transatlantic Economic Council (TEC) and the United States – European Union HighLevel Regulatory Cooperation Forum (HLRCF). 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 and oversees a program of bilateral 

cooperation on regulatory issues. The group has convened in advance of each of the previous

four TEC meetings to identify projects for the TEC to consider.

In November 2011, the Leaders of the United States and the EU launched the U.S.-EU High 

Level Working Group on Jobs and Growth (HLWG) with the objective of identifying new ways 

to increase transatlantic trade and investment in support of job creation, economic growth, and 

international competitiveness. Leaders directed the HLWG to examine options in specific areas 

(including possible trade agreements) inter alia to reduce and prevent non-tariff barriers.

On February 13, 2013, President Obama and EU leaders announced that they would initiate the 

internal procedures necessary to launch negotiations on a Transatlantic Trade and Investment 

Partnership (TTIP). President Obama and EU leaders’ announcement followed issuance of the 

HLWG’s final report to leaders (http://www.ustr.gov/about-us/press-office/reports-andpublications/2013/final-report-us-eu-hlwg) in which it recommended that the United States and 

the EU pursue a comprehensive agreement that would include ambitious, reciprocal market 

opening in goods, services and investment, make substantial progress on reducing non-tariff 

barriers, and address global trade issues of common concern. The report’s specific 

recommendations for negotiations on “regulatory issues and non-tariff barriers” include that a 

comprehensive agreement pursue: SPS and TBT issues; regulatory coherence and transparency; 

sector-specific outcomes and regulatory cooperation; and the development of a framework for 

future U.S.-EU progress on the regulatory issues.

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 
42

United States – Mexico High-Level Regulatory Cooperation Council (HLRCC), comprising 

senior-level regulatory, trade, and foreign affairs officials from each country.

In February 2012, the HLRCC released its first work plan, which outlines cooperative activities 

on food safety, electronic import and export certificates, oil and gas development, 

nanotechnology, motor vehicle safety, and e-health and conformity assessment.45 On October 

15, 2012, the HLRCC met to review progress on the seven work plans. It is expected a new 

consultation schedule will commence in 2013 to update the activities of the HLRCC.

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, with a focus on sectors 

characterized by high levels of integration, significant growth potential, and rapidly evolving 

technologies. The United States – Canada Regulatory Cooperation Council (RCC) website

provides information on specifics for the 29 initiatives and work plans, including cooperation on 

topics such as, agriculture, personal care products, pharmaceuticals, and motor vehicles.

The RCC issued a Progress Report to Leaders on December 14, 2012. The report highlighted that 

work is also underway on the development of Memoranda of Understanding, discussion papers, 

initial statements of work on regulatory changes, and various assessment activities. 

North American Leaders Summit – Trilateral Regulatory Cooperation

The outcomes of the 2012 North American Leaders Summit (“NALS”) provide for opportunities

for Mexico, Canada, and the United States to promote trilateral regulatory cooperation. Benefits 

of trilateral regulatory cooperation will include increased economic growth in the three countries;

lower costs for their citizens, businesses, producers, governments, and consumers; increased trade 

in goods and services across borders; and greater protection of health, safety, and the environment.

In 2013, the four sectors that Mexico, Canada, and the United States have agreed upon for 

trilateral regulatory cooperation are: (1) Regulatory Approach to Nanomaterials;

(2) Transportation Railroad Safety; (3) Transportation Emissions; and (4) Globally Harmonized 

Standards for workplace chemicals. 

Doha Round Negotiations

The U.S. Government’s longstanding objective in the WTO Non-Agricultural Market Access 

(NAMA) negotiations – which cover manufactured goods, mining, fuels, and fish products – has 

been to obtain a balanced market access package that provides new export opportunities for U.S. 

businesses through liberalization of global tariffs and non-tariff barriers. The NAMA 

45 The U.S.-Mexico HLRCC work plan can be found at 

http://www.whitehouse.gov/sites/default/files/omb/oira/irc/united-states-mexico-high-level-regulatory-cooperationcouncil-work-plan.pdf.
43

negotiations have included discussions of several proposals addressing standards-related 

measures, including U.S. proposals covering textiles labeling, electronic products, and 

automobiles.

However, despite continued, intensive efforts by USTR negotiators to engage with key trading 

partners since the launch of the negotiations, the NAMA negotiations reached an impasse in 

2011. In 2012, a new Chairman for the NAMA Negotiating Group was chosen. However, there 

were no substantive meetings or other activities related to either the tariff or non-tariff elements 

of the NAMA negotiations, and negotiations on the standards-related non-tariff barrier proposals 

did not advance.

In 2013, the United States intends to work with other WTO Members to pursue fresh and 

credible approaches to meaningful multilateral trade liberalization.

45

X. 2012-2013 Trends Regarding Standards-Related Measures

This section reviews trends that appear across various U.S. trading partners’ markets, as well as 

standards-related systemic issues, that can significantly affect, both positively and negatively,

the ability of U.S. businesses and producers to access foreign markets.

Nutritional Labeling and Advertising

In 2011, Thailand became the first country to introduce mandatory front of package (FOP) stop 

light labeling on food products for five snack categories. In a stop light labeling system, certain 

nutritional content values are depicted using colors analogous to traffic lights – i.e., red for high, 

amber for moderate, and green for low. After receiving comments from several WTO members 

concerning stop light labeling, Thailand opted to implement the Guideline Daily Amount (GDA) 

system, a guidance system which provides information on to how many calories and nutrients 

people can consume each day for a healthy, balanced diet. Voluntary schemes are also taking 

hold in other countries, with South Korea being the first to press ahead with a voluntary scheme 

for stop light labels on children’s foods in January 2011, and reports from the United Kingdom 

industry indicate that supermarkets will introduce a voluntary, FOP labeling scheme in 2013.

In 2012, several countries in the Western Hemisphere proposed measures related to nutritional 

labeling and advertising. The most restrictive to date has been Chile’s proposed implementing 

regulations for Law No. 20,606. The Chilean Congress adopted this law on July 6, 2012. 

The stated objective of Chile’s draft regulation is to provide the public with information about 

food products in order to prevent obesity and non-communicable diseases. It sets limits for fat 

(trans fat, saturated fat), calories, sugar, and salt, that if exceeded trigger a requirement to place 

a stop sign shaped FOP label on the product indicating that the product is “high in” fat, sugar, 

calories, or salt. The draft regulation requires that the label cover up to 20 percent of the FOP. 

The draft regulation also imposes certain limits on television advertising of particular foods and 

restricts the inclusion of promotional toys and related materials in or attached to products.

The mandatory nature of Chile’s draft regulation, along with its FOP stop sign labeling 

requirements, makes it the most far-reaching nutritional labeling requirement of its kind to date. 

Both Ecuador and Peru are considering similar mandatory and related “high in” claims for 

prepackaged foods and prepackaged food advertising. 

The United States will continue to monitor developments regarding each of these measures and 

engage in follow-up actions, as appropriate.

EU Agreements on Conformity Assessment and Acceptance (ACAA)

The EU is currently pursuing Agreements on Conformity Assessment and Acceptance of 

Industrial Products (ACAAs) with several governments in the Mediterranean region, in 

particular with Algeria, Egypt, Israel, Jordan, Lebanon, Morocco, Palestinian Authority, and 

Tunisia, as well as Ukraine. Jordan and Israel have already adopted ACAAs with the EU as part 

of their Euro-Mediterranean Association Agreements with the EU.

The EU ACAAs cover machinery, electrical products, construction products, pressure 
46

equipment, toys, medical appliances, gas appliances, and pharmaceuticals. Under these 

agreements, parties agree to adopt EU standards and regulations in exchange for eased 

conformity assessment procedures into the EU for certain product sectors. 

U.S. manufacturers have expressed concern that the EU ACAAs will create additional export 

barriers in these regions.

“Voluntary” Measures as Trade Barriers

In various product sectors, certain governments are developing and implementing so-called 

“voluntary” standards in a manner that effectively makes compliance with them mandatory. In 

addition, many truly voluntary standards that governments have developed (such as voluntary 

labeling programs related to energy efficiency or agricultural products) have nonetheless created 

substantial trade barriers. Further, oftentimes voluntary standards may solely reflect domestic 

stakeholder interests rather than also those of the larger global trading community. 

Examples of “voluntary” standards that have raised trade concerns include:

• China’s standards related to information security: The Chinese Government is 

finalizing several draft “voluntary” standards related to information security for 

ICT products. The United States is concerned China will make compliance with 

these voluntary standards mandatory, either through incorporation into technical 

regulations, or through integration into the certification and type approval 

schemes of the Ministry of Industry and Information Technology (MIIT) and the 

CNCA. One such standard, Information Security Technology – Requirement for 

Office Devices Security, appears to restrict the use of computer chips in ink 

cartridges. U.S. and other foreign companies consider that this design restriction 

reduces the functionality of printers, and they question how the measure relates to 

the protection of national security. U.S. industry and the U.S. Government are 

concerned that China may effectively mandate the use of this standard by 

incorporating it by reference into one of China’s various certification regimes, for 

example, the CCC Mark or the MIIT telecom type approval process. U.S. 

industry is also concerned that various versions of the draft standard, including 

prohibitions of certain chips as components of printer cartridges, have diverged 

from the relevant international standard (IEEE 2600). 

• Korea’s standards for solar panels: 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 unable to access the Korean market.

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 regional and 

bilateral engagement as they arise in individual markets. The United States is also seeking to 
47

address these issues on a systemic basis because many of the specific trade concerns that WTO 

Members raise in the TBT Committee continue to be related to standards. Currently, U.S. 

officials are seeking opportunities to tackle the trade issues associated with voluntary standards 

in the APEC Subcommittee on Standards and Conformance and the TPP negotiations.

Mandatory Labeling of Foods Derived from Genetic Engineering

In May 2011, following twenty years of discussions and negotiations, the Codex Alimentarius 

Commission (Codex) adopted a “Compilation of Codex Texts Relevant to Labeling of Foods 

Derived from Modern Biotechnology.” The compilation summarizes existing Codex texts and 

confirms that many Codex labeling guidance documents developed for foods generally also 

apply to foods derived from modern biotechnology. Most importantly, the compilation confirms 

that foods derived from modern biotechnology are not necessarily different from other foods 

simply as a result of the way they are produced. Consistent with that view, the U.S. FDA 

applies a science-based approach to food labeling, which requires labeling of foods derived from 

modern biotechnology only if such labeling is necessary to reveal any material information that 

differs significantly from conventionally produced food in order to avoid misbranding. Such 

information includes proper use of the food, nutritional properties, and allergens.

The United States continues to be concerned about the European Court of Justice (ECJ) ruling 

that honey containing pollen with genetically engineered (GE) material should be considered an 

“ingredient” rather than a natural constituent. As a result, honey with pollen from GE plants 

would have to be approved under the EU’s laws for “genetically modified organisms” and 

labeled for GE content when sold in the EU. The United States has raised this matter in bilateral 

meetings with the European Commission. During the March 2012 WTO Sanitary and 

Phytosanitary Committee meeting, Argentina and Uruguay objected to the ECJ’s ruling as 

creating uncertainty in the markets, which has led to declines in their exports. The United States, 

Mexico, Brazil, Canada, and Paraguay supported the objections. The Codex standard, upon 

which the EU based Directive 2001/110/EC, does not treat pollen as an ingredient and the EU 

was urged to act to withdrawal the measure. In September 2012, the EU Commission proposed 

an amendment to Directive 2001/100/EC to clarify that pollen is not an ingredient of honey, but 

it has not been finalized. In addition, the European Food Safety Authority issued an opinion that 

pollen from the genetically engineered corn approved for cultivation in the EU was equivalent to 

pollen from conventionally bred varieties of corn. The United States most recently raised this 

issue during the TBT Committee meeting of March 2013.

The United States is also concerned by a measure proposed by Peru with regards to labeling of 

foods derived from genetic engineering. Peru renewed its efforts to finalize a regulation 

mandating that all GE ingredients must be included on the labels of processed products. Peru 

notified its Draft Supreme Decree Approving the Regulations Governing the Labeling of 

Genetically Modified Foods to the WTO on June 27, 2011. The regulation requires mandatory 

labeling of all GE foods even though such products may not differ from non-GE products in 

terms of safety or quality. The United States submitted comments to Peru on September 14, 

2011, but Peru has not responded, and has raised concerns with this measures in several bilateral 

meetings in 2012 and 2013. The United States (and other WTO Members) raised this issue 

during the TBT Committee March 2013 meeting as well as during previous meetings.

49

XI. Country Reports

Background on Specific 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.46

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.

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. An analysis of the country 

sections of the 2013 TBT Report demonstrates that numerous 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 numerous countries and the EU, as 

described in the pages that follow.

Argentina

Bilateral Engagement

The United States raises TBT matters with Argentina during TBT Committee meetings.

Testing of All Graphic Products for Lead (Resolution 453)

As previously reported in the 2012 TBT report, the United States continues to be concerned with 

Argentina’s Resolution 453/2010, which requires all inks, lacquers and varnishes used in 

producing printed materials, such as package labeling and inserts, to undergo testing for lead 

46 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).
50

content. Prior to adoption of an amendment in March 2012 (see below), Resolution 453/2010 

required the testing to be conducted in one of two designated laboratories in Argentina. The 

United States expressed concern during TBT Committee meetings in November 2011 and 

March 2012 that this regulation appeared to apply to foreign producers only, and that 

Argentina’s testing capacity was insufficient to perform all the required testing. The United 

States asserted that the situation, coupled with the inability to test these products in the country 

of production, would lead to significant delays, cost and burdens for industry.

In March 2012, Argentina notified an amendment to Resolution 453/2010. Under this 

amendment, Argentina will temporarily accept a sworn declaration from the producer or 

importer that states that the product, or group of similar products, complies with the applicable 

norm, ASTM D 3335-85a in lieu of testing at the designated laboratories in Argentina. This 

alternative procedure, however, will be phased out in stages, ending November 12, 2013.

Both the U.S. and the European Union raised this issue during the March and June 2012 TBT 

Committee meetings. The United States indicated that it continue to question whether 

mandatory third party certification should be required for these products since they are low risk, 

and whether it is necessary for the testing to be performed in Argentina itself or by any 

accredited laboratory. The United States will continue to press Argentina on this issue in 2013.

Electrical and Electronic Products – Conformity Assessment Procedures 

Argentina’s new requirements for conformity assessment for electrical and electronic products,

modifying Resolution 92/98, came into force January 1, 2013, but have not been notified to the 

WTO. Resolution 92/98 specifies the process by which foreign manufacturers and importers 

obtain the S-mark safety certification from local certification bodies. This certification is 

required to market electrical and electronic products between 50 and 1000 Vac in Argentina.

According to U.S. industry, Resolution 92/98 imposes repetitive testing and associated delays,

resulting in costs for U.S. exporters that outweigh the purported safety benefits. In addition, 

industry reports that the requirements disproportionately impact foreign manufacturers and 

importers and favor domestic manufacturers. Failure to follow Resolution 92/98 will result in 

the inability of products to clear customs and enter Argentina’s market.

The United States will continue to press Argentina on this issue in 2013.

Brazil

Bilateral Engagement

The United States and Brazil discuss TBT-related matters in various bilateral fora, including the 

bilateral Commercial Dialogue (led by Brazil’s Ministry of Development, Industry, and 

Commerce and the U.S. Department of Commerce), the Economic Partnership Dialogue (led by 

Brazil’s Ministry of External Relations and the U.S. Department of State), and the U.S. - Brazil 

Commission on Economic and Trade Relations (led by USTR and Brazil’s Ministry of 

Development, Industry and Foreign Trade). The United States also discusses TBT matters with 

Brazil during TBT Committee meetings.
51

Health Products 

As discussed in previous TBT Reports, the United States continues to be concerned with the 

timeliness of the registration of medical devices in Brazil. Resolutions 24 and 25, notified to the 

WTO in May 2009 and also known as Public Consultation 11, establish the requirements for 

manufacturers to submit a Certificate of Good Manufacturing Practice for registration of health 

products. According to Resolutions 24 and 25, a health product is defined as a product that fits 

into one of two categories, either a medical product or a product for in vitro use diagnosis. As 

of May 2010, applicants have had to submit to ANVISA a Good Manufacturing Practices 

(GMP) certificate with their application for registration of health products in Brazil. ANVISA 

issues a GMP certificate only after it has inspected the manufacturing premises. The United 

States is aware that Brazil intends to accelerate GMP inspections. However, according to 

discussions in the 2012 TBT Committee meetings, the average waiting time from submission of 

the inspection request until completion of the inspection is twenty months, while U.S. industry 

reports a wait time of up to 3 years. This is significantly longer than the average time of 3 

months for similar inspections by other accredited auditing bodies. This delay hinders medical 

device exports to Brazil.

The United States and other WTO members raised this issue with Brazil in 2012 at meetings of 

the TBT Committee. The United States pressed ANVISA to accept existing GMP certificates 

without inspection or to consider subcontracting overseas inspections to accredited auditing 

bodies. In 2013 the United States will continue to raise this issue with Brazil.

Telecommunications – Acceptance of Test Results

As discussed in the 2012 TBT Report, the United States continues to be concerned about 

Resolution 323 (November 2002) promulgated by Brazil’s National Telecommunications 

Regulatory Agency (ANATEL). Resolution 323, Standard for Certification of 

Telecommunications Products, only allows testing of products to be performed within Brazil, 

except in cases where the equipment is too large or too costly to transport. As a result, U.S. 

suppliers must present virtually all of their information technology and telecommunications 

equipment for testing at laboratories located in Brazil before that equipment can be placed on 

the Brazilian market. This requirement causes redundant testing, higher costs and delayed time 

to market. Brazil did not notify Resolution 323 to the WTO.

The United States has urged Brazil to implement the CITEL (Inter-American 

Telecommunication Commission) MRA with respect to the United States. Under the CITEL 

MRA, two or more CITEL participants may agree to provide for the mutual recognition of 

conformity assessment bodies and mutual acceptance of the results of testing and equipment 

certification procedures undertaken by those bodies in assessing the conformity of 

telecommunications equipment to the importing country’s technical regulations. The United 

States and Brazil are both participants in CITEL. If Brazil implemented the CITEL MRA with 

respect to the United States, it would benefit U.S. suppliers seeking to sell telecommunications 

equipment into the Brazilian market by enabling them to have their products tested and certified 

in the United States to Brazil’s technical requirements, eliminating the need for U.S. suppliers to 

have their products tested and certified in Brazil. The United States will continue in 2013 to 

encourage Brazil to implement the CITEL MRA with respect to the United States.
52

Chile

Bilateral Engagement

The United States and Chile discuss TBT-related matters in the context of the United States –

Chile Free Trade Agreement, during annual Free Trade Commission and TBT Chapter 

Committee meetings, as well as during the TBT Committee meetings. The last United States –

Chile FTA TBT Chapter Committee meeting was held November 14, 2012.

Food Labeling 

The Chile’s Congress adopted Law No. 20,606 on nutrition and composition of food and food 

advertising on July 6, 2012, and according to the Law, it will be implemented on July 6, 2013. 

Chile notified draft implementing regulations and accompanying guidance on advertising for 

Law No. 20,606 to the WTO in January 2013. These measures were open for comment until 

March 2013, and April 2013 respectively. The stated objective of Law No. 20,606 and its 

implementing regulations is to communicate information to the public about alleged obesity and 

other non-communicable disease risks in certain food. The proposed regulation requires 

manufacturers to place a stop sign-shaped icon on the front of the package (FOP) that covers up 

to 20 percent of the product, if it exceeds limits for fat (trans fat, saturated fat), calories, sugar,

and salt. The icon will carry a warning from the Ministry of Health indicating the food is “high 

in” fat, sugar, calories, or salt. Industry has encouraged Chile to consider existing voluntary 

programs instead. Trade in processed and packaged foods to Chile amounts to $255 million 

annually.

The Chilean Ministry of Health responded to requests from and met with domestic and foreign 

industry members prior to Chile’s WTO notification of the measures. Chilean officials also met 

with U.S. representatives during the November 2012 United States – Chile Free Trade 

Agreement TBT Chapter Committee meeting, and then again bilaterally in March 2013. The

United States raised concerns that the draft regulation is unclear and omits information such as

an explanation of how the regulation applies to foods served in restaurants and to existing 

commercial inventory and whether imports can comply through the use of supplemental labels 

or stickers. The United States also raised concerns that the labeling scheme as proposed would 

take up a significant portion of the packaging for some products, that the stop sign shape is 

unnecessary to communicate the fat, sugar and salt content of the product.

The United States submitted written comments to the Government of Chile on February 26, 

2013 through its WTO Inquiry Point regarding the proposed measures, citing similar concerns, 

including that the draft regulation could have a significant trade impact, that the draft regulation 

sets out a mandatory labeling requirement when voluntary labeling schemes could address 

Chile’s stated objective, and that the timetable for implementation (July 2013) does not leave 

sufficient time for industry to comply or address trading partner concerns. 

The U.S. Government will continue to monitor the situation and seek opportunities to work with 

the Chilean government both bilaterally and in the TBT Committee to ensure adequate 

consideration of comments from stakeholders, a constructive discussion of the rationale, details 

and potential impact of this proposed regulatory approach, and full consideration of less trade 

restrictive alternate approaches. 
53

China

Bilateral Engagement

In addition to discussing TBT issues in the TBT Committee, the United States and China 

regularly engage on TBT-related issues through the United States – 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 information technology

products, and cotton registration requirements.

Food Additives – Formula Disclosure Requirements

In April, 2011, China’s General Administration of Quality Supervision, Inspection and 

Quarantine (AQSIQ) released its “Specification for Import and Export of Food Additives 

Inspection, Quarantine and Supervision (2011 No. 52)” (“Specification”) The Specification, 

effective July 1, 2011, appears to require U.S. and other foreign food producers to disclose their 

proprietary food additive formulas by mandating that food product labels list the precise 

percentage of each food additive. As a result of this requirement, a competitor would have 

access to information that it can use to replicate proprietary formulas and compromise an 

innovator’s legitimate commercial interests. The requirement to disclose product formulas 

appears to apply only to imported food additives.

In addition, China developed and implemented the Specification without notifying the TBT or 

SPS Committees in advance. As a result, neither the United States nor U.S. industry 

stakeholders were aware of, or provided the opportunity to comment on, the proposed 

Specification before AQSIQ issued it. Finally, the measure appears to have taken effect less 

than six weeks after AQSIQ announced it, which did not provide suppliers with adequate time to 

comply. 

In a May 31, 2012 letter to China, the United States raised concerns regarding the serious impact 

on legitimate commercial interests caused by the required disclosure of formulas on labels and 

the apparent application of the Specification only to imported products. The United States

observed that the Specification requirements appeared to diverge from the applicable standards 

in the Codex Alimentarius Commission. The United States also noted that the Specification 

appeared to conflict with China’s own National Food Safety Standard for the Labeling of 

Prepackaged Foods, which China notified to the WTO in April 2010. China’s labeling measure 

requires only the listing of all ingredients in descending order of in-going weight, and provides 

that ingredients used in small amounts for the purpose of flavoring need not be declared on the 

label. The United States emphasized that the regulatory incoherence raised by the Specification 

created uncertainty in the trading community.

The United States continues to urge China to revise its rules governing food additive disclosures 

to better align with international standards and to harmonize its food labeling requirements.
54

China Compulsory Certification (CCC) Requirements – Conformity Assessment Procedures

As previously reported, China’s CNCA requires a single safety mark – the CCC mark – to be 

used for both Chinese and foreign products. U.S. companies continue to report, however, that 

China is applying the CCC mark requirements inconsistently and that many Chinese-produced 

goods continue to be sold without the mark. In addition, U.S. companies in some sectors 

continue to express concerns about duplication of safety certification requirements, particularly 

for radio and telecommunications equipment, medical equipment, and automobiles.

To date, China has authorized 153 Chinese facilities to perform safety tests and accredited 14 

Chinese firms to certify products as qualifying for the CCC mark, as reported in the 2012 USTR 

Report to Congress on China. When it joined the WTO, China committed to provide nondiscriminatory treatment to majority foreign-owned conformity assessment bodies seeking to 

operate in China. Despite this commitment, China so far has accredited only six foreigninvested conformity assessment bodies. It is not clear whether these six bodies play any 

appreciable role in testing or certifying products sold in China. China rejected suggestions that 

it recognize laboratories that have been accredited by ILAC MRA signatories or develop other 

procedures to recognize foreign conformity assessment bodies. It insists that it will accept 

conformity assessment bodies domiciled abroad only if the governments of ILAC MRA 

signatories negotiate MRAs with China. Moreover, China has not developed any alternative, 

less trade-restrictive approaches to third-party certification, such as recognition of a supplier’s 

self-certification.

Because China requires testing for a wide range of products, and all such testing for the CCC 

mark must be conducted in China, U.S. exporters are often required to submit their products to 

Chinese laboratories for tests that may be unwarranted or have already been performed abroad.

This results in greater expense and a longer time to market. One U.S.-based conformity 

assessment body entered into a Memorandum of Understanding (MOU) with China allowing it 

to conduct follow-up inspections (but not primary inspections) of U.S. manufacturing facilities 

that make products for export to China requiring the CCC mark. However, China has refused to 

grant similar rights to other U.S.-based conformity assessment bodies, on grounds that it is 

prepared to conclude only one MOU per country. Reportedly, both Japan and Germany have 

concluded MOUs with China that allow two conformity assessment bodies in each country to 

conduct follow-up inspections.

In 2012, as in prior years, the United States raised its concerns about the CCC mark system and 

China’s limitations on foreign-invested conformity assessment bodies with China both 

bilaterally and during TBT Committee meetings. At the December 2012 JCCT meeting, China 

confirmed that eligible foreign-invested testing and certification entities registered in China can 

participate in CCC mark-related work and that China’s review of applications from foreigninvested entities will use the same criteria as those applicable to Chinese domestic entities. The 

United States will continue to press China on this issue in 2013.

Mobile Devices – WAPI Encryption Standards

The United States continues to have serious concerns regarding China’s 2009 unpublished 

requirement that its WAPI wireless local area networks (WLAN) standard 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
55

Electronics Engineers (IEEE).

In 2011, China’s Ministry of Industry and Information Technology (MIIT) remained unwilling 

to approve any Internet-enabled mobile handsets or similar hand-held wireless devices unless 

the devices were WAPI-enabled. The United States continued to raise concerns with this 

requirement, both bilaterally and in TBT Committee meetings.

A new trade concern related to WiFi standards arose in 2011 when China published a proposed 

voluntary wireless LAN industry standard known as the “UHT/EUHT standard” to be used in 

wireless networks. China’s UHT/EUHT standard appears to be an alternative to the 

internationally recognized IEEE 802.11n standard. MIIT released the UHT/EUHT standard for 

a 15-day public comment period on September 20, 2011 and approved it in February 2012. U.S. 

industry groups commented that the UHT/EUHT standard may not be compatible with either 

WAPI or the IEEE 802.11 standard. Separately, the United States expressed its concern to 

China that the integration of the UHT/EUHT standard into certification or accreditation schemes 

would make the standard effectively mandatory. This could restrict market access for U.S. 

producers. The United States will vigorously pursue a resolution of this issue in 2013.

Mobile Devices – Draft Regulatory Framework

China's MIIT issued the “Draft Mobile Smart Terminal Administrative Measure” (“Measure”)

on April 10, 2012. The Measure established a new regulatory framework for the mobile device 

market. The United States raised concerns about the Measure with China in April and May 

2012. The United States expressed concern that the Measure imposed numerous new 

obligations, technical mandates, and testing requirements on information technology and 

telecommunications hardware, operating systems, applications, app stores, and other related 

services. The scope and mandatory nature of these requirements appear unprecedented among 

the major global markets for mobile smart devices. 

On June 1, 2012, MIIT published a draft of the Measure on its website, soliciting public 

comment for 30 days. In addition, in November 2012, China notified the draft measure to the 

TBT Committee and indicated that it would accept comments for a 60-day period. Both the 

United States and affected industry submitted written comments on the Measure. The United 

States and U.S. industry are concerned that the top-down government-mandated requirements 

contained in the Measure are overly burdensome and could create significant trade barriers.

Furthermore, the United States and U.S. industry are concerned that inclusion in the Measure of 

numerous voluntary standards and testing requirements relating to smart terminals could create 

additional trade barriers if these voluntary standards become mandatory through MIIT’s testing 

and certification process. At the December 2012 JCCT meeting, China confirmed that it will 

take the views of all stakeholders into full consideration in regard to the regulation of 

information technology and telecommunications hardware, operating systems, applications, app 

stores, and other related services. The United States and China will continue to discuss this 

issue as China revises the current draft.

4G Telecommunications - ZUC Encryption Algorithm Standard

At the end of 2011 and into 2012, China unveiled an encryption algorithm (known as the ZUC 

standard), which was developed by a quasi-governmental Chinese research institute for use in 

4G Long Term Evolution (LTE). The European Telecommunication Standards Institute (ETSI) 
56

3rd Generation Partnership Project (3GPP) had approved ZUC as one of three voluntary 

encryption standards in September 2011. According to U.S. industry reports, MIIT, in concert 

with the State Encryption Management Bureau (SEMB), informally announced in early 2012 

that only domestically-developed encryption algorithms, such as ZUC, would be allowed for the

network equipment (mobile base stations) and mobile devices comprising 4G TD-LTE networks 

in China. In addition, industry analysis of two draft ZUC-related standards published by MIIT 

suggests that burdensome and invasive testing procedures threatening companies’ sensitive 

intellectual property could be required.

In response to U.S. industry concerns, the United States urged China not to mandate any 

particular encryption standard for 4G LTE telecommunications equipment used on commercial 

networks, in line with its bilateral commitments and the global practice of allowing commercial 

telecommunications service providers to work with equipment vendors to determine which 

security standards to incorporate into their networks. The United States stated that any mandate 

to use a domestic encryption standard such as ZUC would appear to contravene a commitment 

that China made to its trading partners in 2000, which clarified that China would permit the use 

of foreign encryption standards in IT and telecommunication hardware and software for 

commercial use and that it would only impose strict “Chinese-only” encryption requirements on 

specialized IT products whose “core function” is encryption. Additionally, a ZUC mandate 

would appear inconsistent with China’s 2010 JCCT commitment on technology neutrality. In

2010, China had agreed to take an open and transparent approach that allowed commercial

telecommunication operators to choose which telecommunications equipment and encryption 

technologies and standards to use for their networks and not to provide preferential treatment to 

domestically-produced standards or technology used in 3G or successor networks, so that 

operators could choose freely among whatever existing or new technologies might emerge to 

provide upgraded or advanced services.

The United States pressed China on this issue throughout the run-up to the December 2012 

JCCT meeting. At that meeting, China agreed that it will not mandate any particular encryption 

standard for commercial 4G LTE telecommunications equipment. In 2013, the United States 

will continue to closely monitor developments in this area.

IT Products – Multi-Level Protection Scheme

Beginning in 2010 and continuing through 2012, both bilaterally and during TBT Committee 

meetings, the United States has raised concerns with China about its framework regulations for 

information security in critical infrastructure known as the Multi-Level Protection Scheme 

(MLPS), issued in June 2007 by the Ministry of Public Security (MPS) and MIIT. The MLPS 

regulations put in place guidelines to categorize information systems according to the extent of 

damage a breach in the system could pose to social order, the public interest, and national 

security. The MLPS regulations also appear to require buyers to comply with certain 

information security and encryption requirements that are referenced in the MLPS regulations. 

MLPS regulations bar foreign products from being incorporated into Chinese information 

systems graded level 3 and above. (China grades an information system with respect to its 

handling of national security information, with the most sensitive systems designated as level 5). 

Systems labeled as grade level 3 and above, for instance, must solely contain products 

developed by Chinese information security companies and their key components must bear 
57

Chinese intellectual property. Moreover, companies making systems labeled as grade level 3 

and above must disclose product source codes, encryption keys, and other confidential business 

information. To date, government agencies, firms in China’s financial sector, Chinese 

telecommunications companies, Chinese companies operating the domestic power grid, 

educational institutions, and hospitals in China have issued hundreds of request for proposals 

(RFPs) incorporating MLPS requirements. These RFPs cover a wide range of information

security software and hardware. By incorporating level-3 requirements, many RFPs rule out the 

purchase of foreign products.

Currently, China applies the MLPS regulations only in the context of these RFPs. If China 

issues implementing rules for the MLPS regulations to apply the rules broadly to commercial 

sector networks and IT infrastructure, those rules could adversely affect sales by U.S. 

information security technology providers in China. The United States urged China to notify the 

WTO of any MLPS implementing rules promulgating equipment-related requirements. At the 

December 2012 JCCT meeting, China indicated that it would begin the process of revising the 

MLPS regulations. It also agreed to discuss concerns raised by the United States during the 

process of revision. The United States will continue to urge China to refrain from adopting any 

measures that mandate information security testing and certification for commercial products or 

that condition the receipt of government preferences on where intellectual property is owned or 

developed.

Medical Devices – Conformity Assessment Procedures

The United States has expressed concerns over the past years regarding China’s medical device 

registration requirements. China has not notified proposed revisions to Order 276 “Regulation 

on Supervision and Administration of Medical Devices” to the WTO. Amendments to Order 

276 have been under consideration by the Legislative Affairs Office of the State Council and 

significant revisions were released in 2007, 2010, and in 2012.

The most recent 2012 revision (third draft) of Decree 276 continues to mandate country-oforigin registration, a requirement that prevents foreign manufacturers of medical devices from 

registering their products in China without prior marketing approval in the country of origin or 

country of legal manufacture. According to U.S. industry, this requirement has blocked or 

inordinately delayed sales of safe, high-quality medical devices to the Chinese market because 

some manufacturers did not apply for marketing approval for certain products in the countries in 

which they were produced or in their home countries for reasons unconnected with product 

quality or safety. 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. China continues to 

defend this requirement despite concerted efforts to resolve this issue. The United States will 

continue to press the issue in 2013.

Draft revisions to Order 276 also continue to reflect: 1) problematic product type testing (or 

“sample testing”) requirements; 2) a burdensome re-registration process; and 3) the requirement

that clinical trials be repeated in China in order to register products there. Industry continues to 

advocate for the transition from end-product type testing to a Quality Management System 
58

approach, as outlined in ISO standard 13485. Furthermore, while the latest draft increases the 

validity of a registration from four to five years, China’s re-registration process continues to 

require fees and submissions comparable to the initial registration process.

With respect to the issue of in-country clinical trials, at the 2010 JCCT Subgroup meeting, 

China’s State Food and Drug Administration (SFDA) committed to accept clinical evidence 

from outside China and that China would not automatically mandate in-country clinical trials for 

Class II and Class III devices. However, the latest revision of Decree 276 proposed a waiver of 

in-country clinical trials for Class I (lowest risk) devices only and remains unclear on potential 

waivers of clinical trials for Class II and Class III devices. In bilateral discussions with China in 

2012, the United States urged China to meet with stakeholders to discuss their concerns. The 

United States will continue to monitor the development of revisions to Order 276 in 2013.

Imaging and Diagnostic Medical Equipment – Classification

Another source of concern relates to China’s classification of imaging and diagnostic medical 

equipment. China classifies most imaging and diagnostic medical equipment as Class III. This 

classification represents the highest risk and therefore it is the most stringent classification for 

medical devices. This classification is problematic because it deviates from international 

practices and burdens manufacturers with additional requirements, such as conducting expensive 

and potentially unnecessary domestic clinical trials.

During the 2011 JCCT meeting, the United States urged China to place certain imaging and 

diagnostic medical equipment into a lower risk category. China’s SFDA committed to issue, by 

June 2012, a complete list of x-ray equipment to be placed in a lower risk category and agreed to 

endeavor to release a draft for an in vitro (e.g., test tube) diagnostic equipment catalog for public 

comment by June 2012. Subsequently, in August 2012, SFDA revised and lowered the 

classification for four sub-categories of imaging and diagnostic medical equipment under the 

“Classification Catalogue of Medical Devices,” including certain medical ultrasonic instruments 

and related equipment, medical x-ray equipment, medical x-ray ancillary equipment and 

components, and medical radiation protective equipment and devices. The United States will 

work in 2013 to ensure that China fully implements its commitment.

Patents Used in Chinese National Standards

In the State Council’s Outline for the National Medium to Long-Term Science and Technology 

Development Plan (2006-2020) and in the 11th Five Year Plan (2006-2010) for Standardization 

Development of the Standardization Administration of China (SAC), China prioritized the 

development of national standards. 

In November 2009, SAC circulated for public comment proposed “Provisional Rules Regarding 

Administration of the Establishment and Revision of National Standards Involving Patents.”

The provisional rules indicated that in principle a mandatory national standard should not 

incorporate patented technologies. The draft provisional rules also indicated that when the use 

of patented technologies was needed a compulsory license could result if the relevant 

government entity was unable to reach agreement with the patent holder. The United States 

provided comments opposing this and other aspects of the draft provisional rules, which did not 

take effect. In December 2012, SAC circulated new draft interim measures, omitting certain 

troubling aspects of the earlier draft, such as the compulsory license provision, but raising other 
59

concerns, including in its definition of the responsibilities and potential liabilities of individuals 

and organizations that participate in the formulation of revision of national standards. In early 

2013, the United States provided comments to SAC on these and other concerns. The United 

States will continue to engage with China on this issue in 2013.

Electronic Information Products – Certification of Pollution Control 

The United States continues to be concerned by China’s Administrative Measures for 

Controlling Pollution Caused by Electronic Information Products, issued by MIIT and several 

other Chinese agencies effective March 2007. This measure (known as “China RoHS”) is 

modeled after existing European Union regulations. While the regulations of both China and the 

EU seek to ban lead and other hazardous substances from a wide range of electronic products, 

there are significant differences between the two regulatory approaches.

China’s original RoHS regulations were developed without any formal process for interested 

parties to provide input to MIIT and were not timely notified to the TBT Committee. As a result,

stakeholders outside China had limited opportunity to comment on proposals or to clarify 

MIIT’s implementation intentions. The regulations omitted basic information, such as the 

specific products subject to mandatory testing and the applicable testing and certification 

protocols. Industry in the United States and other countries expressed concern that producers 

would have insufficient time to adapt their products to China’s requirements and that in-country 

testing requirements would be burdensome and costly. China circulated subsequent proposed 

revisions to its RoHS regulations in 2010 and in 2012. U.S. industry submitted comments on 

the July 2012 draft revision.

Concurrent with these developments, China issued the catalog of electronic information 

products subject to hazardous substance restrictions and mandatory testing and conformity 

assessment under the China RoHS regulations. The final version of the catalog included mobile 

phones, other phone handsets, and computer printers. Information on the applicable testing, 

certification, and conformity assessment regime was not included in either the draft or final 

catalog. MIIT and CNCA also introduced a voluntary program in November 2011 to certify 

electronic information products to the China RoHS limits established for six substances. The 

United States will carefully monitor developments in this area in 2013.

Cosmetics –Approval Procedures and Labeling Requirements

SFDA initiated a series of changes to China’s cosmetics regulation after obtaining jurisdiction 

over the industry in 2008. SFDA imposed additional requirements on “new ingredients” in 

April 2010, and promulgated guidance on the application and evaluation of new cosmetic 

ingredients in 2011. These actions stalled the approval of cosmetics containing new ingredients. 

In fact, SFDA has approved only a handful of new ingredients since 2010. The United States, 

along with EU and Japan, continue to raise concerns regarding the application requirements at 

TBT Committee meetings.

In December 2012, China notified “Cosmetics Label Instructions Regulations” and “Guidance 

for the Cosmetics Label Instructions,” which propose new labeling requirements that are in 

addition to the two existing labeling requirements that apply to cosmetic products. In January 

2013, industry submitted comments through the U.S. TBT Inquiry Point, arguing that the 

proposed regulation overlaps and conflicts with existing Chinese regulations, as well as creates 
60

an undue burden for the industry. 

The United States is also monitoring possible implications of SFDA’s efforts to create an 

inventory of “existing ingredients” that have been approved for use in cosmetics products in 

China. In September 2012, SFDA released for comment the “SFDA Notification: List of Raw 

Materials Already in Use in Cosmetics (Third Batch).” The first and second lists of materials

were released in April and July 2012, respectively.

The United States will urge China to continue dialogue with all interested parties regarding 

these measures and to take into account the comments received. China should also consider 

alternative measures that are more commensurate with the risks involved, such as post-market 

surveillance and reliance on internationally-recognized good manufacturing practices (GMPs). 

These alternatives would meet China's legitimate regulatory objectives with fewer disruptive 

effects on international trade.

Colombia

Bilateral Engagement

The United States discussed TBT matters with Colombia during and on the margins of TBT 

Committee meetings, and in the TBT Chapter Committee of the United States – Colombia FTA. 

The first meeting of this committee was held October 23-24, 2012.

Distilled Spirits – Identity Requirements

Prior TBT Reports outlined U.S. industry’s concerns over the quality and identity requirements 

that Colombia proposed in 2009 for distilled spirits, including gin, rum, vodka, and whiskey.

On August 24, 2012, Colombia notified to the WTO a final version of its alcoholic beverage 

regulation, which contained standards of identity for distilled spirits based on analytical 

parameters, such as a limit on congeners and other naturally occurring constituents of gin, vodka, 

and rum. The regulation provides for a 12-month transition period. Unlike Colombia’s approach, 

the standards of identity for distilled spirits sold in the United States, the European Union, 

Canada, and nearly every other major spirits market bases their standards of identity on the raw 

materials and processes used to produce distilled spirits. In response to Colombia’s notification, 

the United States submitted written comments expressing concern about Colombia’s approach 

of basing identity requirements on chemical composition rather than raw materials and 

processes used to produce the distilled spirits. The United States will continue to monitor this 

issue in 2013.

Commercial Vehicles – Diesel Emissions

As raised in prior TBT Reports, the United States remains concerned about the Ministry of the 

Environment and Sustainable Development’s draft resolution amending Resolution No. 910 of 

2008. On December 14, 2012, the Government of Colombia notified this proposed measure to 

the WTO. Amended Resolution No. 910, which is proposed to go into effect August 5, 2013, 

indicates that the current commercial vehicles emission standards in Colombia, EPA 98 (a U.S. 

standard) and EURO III (an EU standard), will not be valid for new commercial vehicles 

seeking registration for sale in Colombia and that EPA 04 and EURO IV emission standards will 
61

be accepted for long haul semitrailers until December 2014. The draft resolution further 

provides that by January 2015, all commercial vehicles seeking registration for sale in Colombia 

must meet EURO IV emission standard requirements. Given the design of some U.S.-

manufactured diesel truck engines, industry has expressed concern that use of this EU standard 

would effectively exclude many U.S. heavy duty trucks from the Colombian market. Further, 

according to EcoPetrol, the Colombian state-run oil company, the fuel necessary to comply with 

the standard will not be available nationwide until 2017. This situation is exacerbated by the 

fact that engines designed to meet EPA 04 standard, which is more stringent than the EURO IV

standard, already face restricted access to the Colombian market, because Colombia does not 

maintain adequate supplies of the high-quality fuel needed for these high technology engines. 

The United States has encouraged Colombia to focus efforts on removing older trucks from the 

road to achieve the most immediate and significant emissions reductions. In 2012, the United 

States raised concerns during the first meeting of the United States – Colombia FTA TBT

Committee meeting, engaged in technical exchanges, and raised the issue on the margins of the 

March and June TBT Committee meeting.

In 2013, the United States will respond to the WTO notification of the draft resolution, and will 

continue to raise concerns about the measure bilaterally and in the WTO.

The European Union

Bilateral Engagement

The United States has actively engaged the EU on TBT-related matters in the TBT Committee,

the WTO Trade Policy Review of the EU, and in bilateral meetings. The United States also 

raises concerns and encourages reform in EU approaches to key TBT issues in the Transatlantic 

Economic Council (TEC) and the United States – European Union High-Level Regulatory 

Cooperation Forum (HLRCF).

In addition, the United States and the EU work together to promote the importance of 

maintaining open and transparent regulatory and standards development processes in emerging 

markets, as well as jointly advocating on specific market access issues on behalf of US and EU 

exporters.

The announcement by President Obama and EU leaders that the United States and the EU intend 

to pursue a comprehensive trade and investment agreement will provide new opportunities to 

address TBT-related issues with the EU.

Honey – Biotechnology Labeling

EC Regulation No. 1829/2003 addresses GE crops for food use and for animal feed. The United 

States, along with other WTO Members, has expressed concerns in TBT Committee meetings,

most recently in March 2013, regarding the requirement in Regulation No. 1829/2003 that 

honey containing pollen derived from GE plants must be labeled as such in accordance to EU 

regulations. This requirement was the result of the ECJ 2011 decision in Case C-442/09 that 

interpreted EC Regulation No. 1829/2003. The United States will continue to monitor this issue 

in 2013. In September 2012, the EU Commission proposed an amendment to Directive 

2001/100/EC to clarify that pollen is not an ingredient of honey, but it has not been finalized. In 
62

addition, the European Food Safety Authority issued an opinion that pollen from the genetically 

engineered corn approved for cultivation in the EU was equivalent to pollen from 

conventionally bred varieties of corn. The United States raised this issue during the March 2013 

TBT Committee meeting.

In addition, industry has raised concerns on several occasions about the impact the EU’s 

restrictive stance on biotechnology has had on U.S. exports of soy, grains, corn, and other crops.

The United States have repeatedly raised concerns and objections with the EU regarding the 

EU’s biotechnology regulations and legislation and their detrimental effect on U.S. exports. 

With respect to SPS issues arising from the EU’s policy regarding food and agricultural 

products derived from modern biotechnology, please refer to the SPS Report.

Accreditation Rules

As noted in previous TBT Reports, the United States has serious concerns regarding the EU’s 

accreditation framework set out in EC Regulation No. 765/2008. The regulation, which became 

effective in January 2010, 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-forprofit entities. 

Under the regulation, Member States can recognize non-European accreditation bodies at their 

discretion. 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 or certified by 

conformity assessment bodies accredited by non-European accreditation bodies.

The United States will continue to press the EU on these issues in 2013.

Foods - Quality Schemes

New framework legislation for quality schemes in agriculture, EU No. 1151/2012, became 

effective in January 2013. The quality schemes provide for (1) “certification” procedures, in 

which detailed specifications are checked periodically by a competent body and (2) “labeling” 

systems to communicate information regarding product quality to the consumer, and which are

subject to official controls. The United States is concerned with an element of the legislation 

that establishes a new framework for the development and protection of optional “quality terms.”

For example, it creates and protects the term “mountain product.”

In particular, the United States is concerned that the legislation incorporates commonly used 

terms into the EU’s quality schemes and subjects them to registration requirements. The United 

States is concerned that, as result, the legislation will negatively impact U.S. producers’ ability 

to export and market their products in the EU. The United States will seek to work with the EU

to address these concerns in 2013.

Chemicals – REACH Regulation

The EU’s REACH regulation imposes extensive registration, testing, and data requirements on 

tens of thousands of chemicals. REACH also subjects certain chemicals to an authorization 
63

process that would prohibit them from being placed on the EU market except for specific uses. 

U.S. industry is concerned 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. Since 

U.S. monomer suppliers are generally not located in the EU, U.S. polymer producers cannot 

likewise rely on registrations of their monomer suppliers. 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

registration requirement.

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 

procedures. Differing interpretations between the Commission and several Member States 

regarding when these obligations apply has created uncertainty among industry over how to 

comply. The Commission has indicated that notification and communication obligations apply 

if a substance on the Candidate List is present in an article in concentrations above 0.1 percent 

of the article’s entire weight. However, Member States have stated that these obligations should 

apply when a substance on the Candidate 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 part of what may have been an effort to seek to 

protect the EU market from imports. Departure from the Commission’s 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 and

differing registration requirements for EU and non-EU entities. In general, the European 

Commission regularly publishes notices of draft EU measures in the Official Journal of the 

European Union and sends notifications to the WTO Secretariat. However, U.S. and other nonEU interested persons allege such notifications occur far too late in the process for them to 

familiarize themselves with the new requirements and submit timely comments. In advance of 

these notifications, European Commission trade and regulatory officials consult primarily with 

EU stakeholders.

The United States has raised concerns regarding REACH at nearly every TBT Committee 

meeting since 2003, and has been joined by many other WTO Members, 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.

In addition, the United States registered concerns with the EU during the November 2011 TBT 

Committee meeting regarding a costly REACH requirement, applied only to manufacturers 
64

outside the EU, to appoint “Only Representatives” (ORs). An OR is a natural or legal person 

established in the EU authorized to carry out the obligations that REACH imposes on importers. 

REACH bars U.S. producers from registering substances for use in the EU and thus they must 

engage an OR for this purpose. 

The United States also encouraged the EU to address in its 2012 REACH review data 

compensation issues in connection with the operation of Substance Information Exchange 

Forums (SIEFs). Specifically, U.S. industry has raised concerns that the “lead registrant” for 

each SIEF may take commercial advantage of its position in dealing with other SIEF members, 

particularly SMEs. Because other SIEF members must negotiate with the lead registrant to 

register their chemicals, a lead registrant could unfairly charge members registration fees at a 

level that would reduce competition in the EU market. The United States urged the EU to 

consider issuing guidance for cost-sharing that would place limits on what lead registrants can 

charge other SIEF members, thus preventing undue financial burdens on those members, 

especially SMEs.

The United States will continue to monitor closely REACH implementation in 2013, and will 

raise trade concerns, as appropriate, in the TBT Committee and other pertinent fora. 

Wine – Traditional Terms

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 if their governments enter into an agreement with the EU regulating use of the terms in 

their markets. Regulation EC No 607/2009 implements EU protections on designations of 

origin and geographical indication, traditional terms, labeling, and presentation of certain wine 

products.

The EU’s regulation of traditional terms severely restricts the ability of non-EU wine producers 

to use common or descriptive and commercially valuable terms to describe their products sold in 

the EU. While no shipments have been blocked, U.S. industry reports that the regulation has

deterred exporters from seeking to enter the EU market. The EU’s efforts to expand the list of 

so-called “traditional terms” to include additional commercially valuable terms are also 

problematic because some of these terms do not have a common definition across all EU 

Member States. Additionally, the United States remains concerned about the EU’s decision to 

withdraw permission to use certain “traditional terms” under the United States – EU agreement

on trade in wine, as well as the EU’s limitation on the use of traditional expressions in 

trademarks.

The EU justifies these above-mentioned efforts to limit use of traditional terms on the ground 

that misuse of the terms may confuse consumers. However, these terms have been used without 

incident on U.S. wines in the EU market for many years. Moreover, the EU has allowed the use 

of the terms by other countries, including Chile, South Africa, Canada, and Australia. Although 

the EU recently approved the use by U.S. industry of the terms “cream” and “classic” it has not 

issued a decision with respect to use on U.S. products of the terms “chateau,” “clos,” “ruby,”

and “tawny.” During 2013, the United States will continue to coordinate with U.S. wine 

exporters on how best to address and resolve concerns regarding the EU’s wine policy, and will 

engage with EU officials at the TBT Committee and in bilateral meetings.
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Distilled Spirits – Aging Requirements

The EU requires that for a product to be labeled “whiskey” it must be aged a minimum of three 

years. U.S. whiskey products that are aged for a shorter period cannot be marketed as “whiskey” 

in the EU market or other markets such as Israel and Russia that adopt EU standards. The 

United States views a mandatory three-year aging requirement for whiskey as unwarranted. In 

fact, recent advances in barrel technology enable U.S. micro-distillers to reduce the aging time 

for whiskey. Variations in climate can also shorten aging time. In 2013, the U.S. will continue 

to urge the EU and other trading partners to end whiskey aging requirements that serve as 

barriers to U.S. exports.

Biofuels – Renewable Energy Directive 

The EU’s renewable energy directive (RED) provides for biofuels (such as biodiesel and 

ethanol) and biofuel feedstocks (such those derived from soybeans or canola) to be counted 

toward fulfilling Member State biofuel use mandates. It also provides for biofuels and biofuels 

feedstocks to benefit from RED tax incentives but only if they qualify for a sustainability 

certificate. However, to qualify for a sustainability certificate biofuel or biofuel feedstock must 

meet a patchwork of standards or be subject to a bilateral agreement with the EU. The use of 

varying approaches and sustainability standards has disrupted U.S. trade in soybeans.

To find alternative approaches to address U.S. concerns with the EU’s certification scheme, the 

United States and the EU began discussions to explore a possible bilateral agreement that would 

recognize that longstanding U.S. conservation programs correspond to RED sustainability 

criteria. In July 2011, a high-level delegation from the U.S. Government met with officials from

the EC Directorate-Generals for Trade and Energy to address U.S. concerns. Additional 

discussions were held in September, November, and December 2011, leading to the creation of a 

working group to explore the possibility of a bilateral agreement as provided for under the RED. 

The working group met in February, April and June 2012, but did not reach agreement on the 

basis for a bilateral agreement. In the November 2012 TBT Committee meeting, the United 

States continued to urge the EU to show flexibility and openness in recognizing different 

approaches that could provide equivalent outcomes when it comes to sustainable energy

feedstocks. In 2013, the United States will continue to work with the EU and push for 

resolution of U.S. concerns.

India

Bilateral Engagement 

The United States discusses TBT matters with India in various fora including the TBT 

Committee, the United States – India Trade Policy Forum (TPF), the United States – India 

Commercial Dialogue, and the High-Technology Cooperation Group. The United States and 

India also engage in ad hoc bilateral discussions. For example, the United States and India 

conducted a digital video conference on standards and conformity assessment on December 12, 

2012. Similar conferences are planned for 2013.

In addition, the Confederation of Indian Industry (CII) and ANSI have added India-specific 

content on relevant standards, conformity assessment, and technical regulations in India to 

ANSI’s standards portal.
66

Cosmetics – Registration Requirements 

In April of 2008, India notified to the WTO an amendment to its “Drugs and Cosmetics 

(Amendment) Rules of 2007” that introduced a new registration system for cosmetics products 

that U.S. industry believes to be overly burdensome and costly, and lead to unnecessary delays 

to market for companies’ products. 

In 2009 and 2010, U.S. industry sought clarifications in a number of areas, and India made a 

number of modifications to the measure and developed implementing guidelines. The United 

States raised the issue at the June 2012 TBT Committee meeting. In particular, the United 

States expressed concern that under the guidelines the registration certificates and import 

licenses for foreign producers must be renewed every three years, while the certificates and 

licenses for domestic producers are valid for five years. 

India has not yet addressed these concerns and has indicated that the guidelines will enter into 

force on March 31, 2013. In 2013, the United States will continue to monitor the implementation and 

changes to the guidelines and press for changes that address U.S. concerns.

Foods Derived from Biotech Crops

India’s biotechnology regulatory and approval system prohibits the importation of food and 

agricultural products containing ingredients derived from biotech crops such as corn and 

soybeans, with soybean oil being the sole exception.

On June 5, 2012, India’s Department of Consumer Affairs proposed an amendment to the Legal 

Metrology (Packaged Commodities) Rules, 2011 that would require, inter alia, that the term

“GM” be placed on the principal display panel of packages containing genetically engineered 

foods. 

The United States will continue to monitor this issue in 2013. 

Telecommunications Equipment – Information Security Regulations 

In 2009 and 2010, India imposed new requirements in telecommunications service licenses,

including mandatory transfer of technology and source codes as well as burdensome testing and 

certification for telecommunications equipment. Following extensive engagement with trading 

partners including the United States, India eliminated most of these requirements in 2011. In 

doing so, however, India adopted new telecommunications license amendments that continue to 

require, among other things, that as of April 2013, testing of all telecommunications equipment 

deemed to raise security concerns take place in India. The U.S. Government and industry 

continue to press India to reconsider the domestic testing policy and to adopt the international 

best practice of using international common criteria and accepting products tested in any 

accredited lab, whether located in India or elsewhere.

The United States will continue to monitor this issue in 2013. 
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Toys and Toy Products – Registration and Testing Requirements

The United States continues to be concerned about the proposed “Toys and Toy Products 

(Compulsory Registration) Order” being considered by the government of India. As noted in 

the 2012 TBT Report, the registration order, if implemented, would impose onerous and time 

consuming registration obligations on U.S. toy companies and conformity assessment burdens 

that are dramatically higher than those found in any other country.

The proposed manufacturer’s self-declaration provisions require an extremely detailed and 

onerous level of information, including submission of a registration form that contains 

information concerning management composition, raw materials, components, machinery 

(including the serial numbers for all equipment on the factory floor and notification whenever a 

piece of equipment is removed from the factory, even for maintenance), factory layout, 

production processes, packing/storage, inspection, and quality control staff for each plant at 

which the imported toys are manufactured. Much of this information is unnecessary as it does 

not demonstrate anything about the quality or safety of the toy nor the quality of the 

manufacturing process. 

In addition, the proposed rule requires test reports on samples of any toy or toy product 

conducted by a Bureau of Indian Standards (BIS)-recognized laboratory in India or by an 

overseas laboratory that has a mutual recognition agreement with BIS, of which there are none.

Test reports from ILAC-accredited laboratories are not accepted under this proposed rule. As 

noted in the 2012 TBT Report, it appears India’s safety objectives are currently – and can 

continue to be – achieved by accepting test results from internationally recognized laboratories,

such as ILAC-accredited laboratories.

Indonesia

Bilateral Engagement

The United States discusses TBT matters with Indonesia both bilaterally and during TBT 

Committee meetings. The United States – Indonesia TIFA Council provides a forum for 

bilateral discussions on a variety of trade-related issues, including standards-related issues. The 

United States and Indonesia also participate actively on standards and conformance issues 

through APEC.

Horticulture Products – Labeling Requirements

In September 2012, Indonesia issued Ministry of Agriculture’s (MOA) Regulation 60 and 

Ministry of Trade’s (MOT) Regulation 60 (amending MOT Regulation 30). These regulations 

impose a broad range of requirements on the importation of horticultural products into Indonesia

and include provisions related to labeling. MOA’s Regulation 60 requires that MOA consider 

the “packaging requirement and labeling in Indonesian,” among other considerations prior to 

issuing a “recommendation for the import of horticultural products” or RIPH. MOT’s

Regulation 60 contains labeling and packaging requirements. For instance, the regulation 

requires that Bahasa Indonesia labels be attached to the packaging prior to entering the 

Indonesian customs area. Indonesia did not notify these regulations to the TBT Committee.
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The United States raised concerns about the labeling and packaging requirements contained in 

these measures at the November 2012 TBT Committee, as well as in numerous bilateral 

meetings. The United States requested that a WTO dispute settlement panel be established 

regarding MOT regulation 60 and MOA regulation 60, as well as other regulations in connection 

with their import licensing and quantitative restrictions in March 2013. The United States will 

continue to raise concerns in 2013 regarding the labeling aspects of the measures.

Processed Foods – Bahasa Labeling Requirement

In September 2010, Indonesia’s National Agency for Drug and Food Control (BPOM) 

announced that it would require all imported processed food products to be labeled exclusively 

in the Bahasa language and require the labels to be affixed to product containers prior to 

“entering Indonesian territory” effective March 1, 2011. Indonesia agreed to a U.S. request to 

delay enforcement until March 1, 2012. Also in response to U.S. concerns, Indonesia agreed to 

accept supplemental Bahasa language labels in lieu of original, exclusive Bahasa language 

labeling.

In June and July 2012, Indonesia notified two new BPOM regulations to the TBT Committee, 

G/TBT/N/IDN/60 and G/TBT/N/IDN/59, laying out new requirements for registration and 

labeling for processed foods. Together, the measures establish an extensive and complex 

registration system for processed food products and burdensome labeling requirements,

including mandating the disclosure of confidential and proprietary information and requiring 

unnecessary warning statements for products containing colorants and artificial sweeteners. At 

the November 2012 TBT Committee, the United States raised concerns and asked that Indonesia 

delay enforcement until after comments from interested parties could be taken into account. The 

U.S. submitted written comments in August 2012. 

Effective January 2013, Bahasa language labeling before entering Indonesia is required. 

However, enforcement is done via signed statements from importers stating that labeling 

requirements are met. BPOM conducts periodic checks at importers’ warehouses since they are 

not allowed to enter customs areas. In 2013, the United States will continue to raise concerns 

regarding these requirements.

Food, Supplements, Drugs, and Cosmetics – Distribution License Requirements

In 2009, BPOM announced licensing requirements for companies that distribute food, health 

food supplements, drugs, and cosmetics in Indonesia, including imported products. Although 

the proposed licensing requirements vary by product type, they all could significantly disrupt 

trade. For example, imported food distributors would be required to provide reference letters 

from the overseas production facility, certifications for health or halal status, and a certificate 

stating that the production process was radiation free. The United States raised concerns about 

the proposed licensing requirements with Indonesia bilaterally and in TBT Committee 

meetings. BPOM issued a proposed replacement regulation in early 2011, which addresses 

some of the potentially burdensome requirements. For example, the revised proposal no longer 

requires halal certificates for products that do not claim to be halal consistent. The United 

States will continue to raise concerns with this regulation with Indonesia.
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Toys – Standards and Testing Requirements

In 2012, Indonesia’s Directorate General of Manufacturing Industries proposed to enforce a 

recently enacted toy safety standard, SNI 8124:2010. The U.S. toy industry is concerned that 

the safety standard will require redundant and burdensome in-country testing. The United States 

raised concerns regarding SNI 8124:2010 bilaterally and in TBT Committee meeting in 

2012. At the request of the United States, Indonesia notified the draft decree to the WTO in July 

2012, as G/TBT/N/IDN/64. The United States is encouraging Indonesia, in lieu of in-country 

testing, to allow foreign suppliers to provide laboratory test reports by ILAC- accredited 

laboratories. Recognition of test results from ILAC-accredited laboratories is common 

international practice in the toy sector, prevents market-access delays, and reduces the burden on 

local testing and certification facilities. The United States also raised concerns over the 

requirement that toys be affixed with a mark indicating compliance with SNI ISO 9001:2008. 

Indonesia has responded that it is in the process of developing technical guidance concerning the 

requirement. The United States will remain engaged on this subject as Indonesia develops its 

guidance and continue to press Indonesia to accept testing performed by ILAC-accredited 

laboratories.

Japan

Bilateral Engagement 

The United States discusses TBT issues with Japan bilaterally, including through the United 

States – Japan Economic Harmonization Initiative (EHI) established in November 2010, as well 

as in multilateral fora such as the TBT Committee. 

Organic Product Requirements 

During 2012, the United States actively engaged Japan through a series of bilateral meetings to 

address outstanding issues regarding trade in organic products, and initiate negotiations towards 

increasing bilateral trade in these products. These meetings have facilitated the technical 

exchange needed to bring U.S. concerns closer to resolution, and the United States and Japan are 

engaged in the negotiation of a possible mutual organic equivalence arrangement. 

While the negotiations are underway, the United States continues to raise specific concerns with 

Japan. In contrast to U.S. organic standards, Japan will not certify as organic any agricultural 

products produced with alkali extracted humic acid or lignin sulfonate. Humic acids are used in

farming to improve soil structure, increase water retention, promote seed germination, and 

improve yields. Lignin sulfonate is used as a flotation device for cleaning fresh fruits. 

The United States also continues to express concern that Japan does not allow the use of the 

Japan Agriculture Standard (JAS) organic logo in conjunction with U.S. logos. In addition, 

Japan does not allow USDA certified products to affix the JAS logo in the United States, unless 

the certifier is JAS accredited. The product must instead be imported into Japan by a JAS 

accredited importer who then affixes the required JAS organic logo. The cost of doing this in 

Japan adds additional cost to the product. This topic is being discussed in the equivalency 

negotiations.
70

The United States will continue to work closely with Japan to address these concerns through 

the negotiation process and hopes to improve access to Japan’s market for U.S. organic products.

Kenya

Bilateral Engagement

The United States discusses TBT matters with Kenya both bilaterally and during TBT 

Committee meetings. The United States – East African Community (EAC) TIFA Council also 

provides a forum for bilateral discussions of standards-related issues.

Alcoholic Beverages – Labeling Requirement

As noted in the 2012 TBT Report, Kenya previously notified in 2011 labeling requirements, the 

“Alcoholic Drinks Control (Licensing) Regulations,” for alcoholic beverages. The requirements, 

which are presently suspended because of domestic litigation, could prove onerous to U.S. 

exporters if they go into effect. For example, one of the requirements is that a warning message 

comprise at least 30 percent of the package’s surface area. 

In December 2012, Kenya notified to the WTO proposed revisions to the measure. The 

revisions appear to make some positive changes, such as removing the restriction that foreign 

broadcasts and publications cannot promote alcoholic beverages, however, the revision still 

requires that a warning message appear on the package although there is uncertainty as to its 

required size. In January 2013, the United States requested clarification on the size of the 

warning label and stated that the requirement to change the warning statement every 100 bottles 

appears to be overly restrictive and burdensome.

The United States will continue to closely monitor this issue in 2013. 

Korea

Bilateral Engagement 

Korea and the United States regularly discuss TBT issues through bilateral consultations. The 

consultations serve as an important forum for discussing and resolving these issues and are 

augmented by a broad range of senior-level policy discussions. In June 2012, the United States 

and Korea held bilateral trade consultations leading to the resolution of a number of TBT issues,

such as avoiding duplicative electrical safety testing and the adoption of the latest international 

standard for electronic devices and providing a one-year grace period for new cosmetic labeling 

regulations to allow industry time to adjust. In addition, the United States raises TBT issues 

with Korea during and on the margins of TBT Committee meetings. Opportunities for bilateral 

engagement on TBT issues will continue to increase through the work of the TBT Committee 

and an Automotive Working Group, established under the United States – Korea Free Trade 

Agreement, which entered into force on March 15, 2012. 

Cosmetics – Labeling

In August 2012, the National Assembly proposed legislation that would require labeling for all 

packaging of all cosmetics products despite existing exemptions for small packages under 10 ml 
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or grams. U.S. companies will potentially encounter a considerable financial burden if the bill is 

enacted into law. Consequently, the United States will continue to monitor this issue in 2013.

Chemicals – Act on the Registration and Evaluation of Chemicals (REACH) 

In February 2011, Korea’s Ministry of Environment (MOE) released a draft “Act on the 

Registration and Evaluation of Chemicals (REACH)” to the National Assembly. As announced, 

Korea REACH would create a complex registration system for chemical products, perhaps as 

early as 2014. U.S. industry submitted comments to MOE on Korea’s proposal, and the United 

States raised this issue with Korea bilaterally and in the TBT Committee in June and November 

2011.

In 2012, Embassy Seoul monitored the draft Act and continued to discuss concerns about the 

burden and lack of clarity of Korea’s proposed Act, in particular the draft law’s proposed de 

minimis level of 0.5 tons (rather than the EU REACH one ton) and duplicative reporting 

requirements. Many of these concerns, including the de minimis level and reporting 

requirements, were addressed in the version of the Act that MOE submitted to the National 

Assembly in September 2012. The Act has not been approved by the National Assembly, and 

the legislature continues to work with the MOE to refine the legislation; it is unclear whether 

areas in which MOE reflected industry comments will all be maintained in the final law. The 

United States seeks to ensure that Korea’s final requirements are not unnecessarily traderestrictive. 

In 2013, the United States will continue to monitor developments related to the proposed 

registration system and urge Korea to take U.S. industry’s comments into account. 

Organic Products – Requirements and Conformity Assessment Issues

Korea’s Act on Promotion of Eco-Friendly Agriculture and Management of Organic Products 

(the “Organic Products Act”) becomes effective on May 29, 2013. The Organic Products Act 

clarifies requirements previously adopted in 2008 for organic certification and labeling that 

mandate certification of processed organic products by a certifier accredited by the Ministry of 

Food, Agriculture, Fisheries, and Forestry (MIFAFF). Under the new requirements, U.S. 

organic products would need to be re-certified to maintain their organic labeling. Many U.S. 

producers and certifiers are reluctant to seek product re-certification due to the difficulty of 

ensuring that individual ingredients also meet certification requirements. However, the Organic 

Products Act permits the conclusion of equivalence agreements, which might alleviate burdens 

on U.S. products. Nevertheless, the Organic Products Act does not permit equivalence 

agreements to go into effect until January 2014. The United States, Canada, Australia, New 

Zealand, and the European Union requested Korea to suspend its new certification and labeling 

requirements until equivalence agreements can be concluded. On November 13, 2012, Korea 

agreed to this request and will permit foreign organic products to be labeled as organic in Korea 

without MIFAFF-accredited certification. The United States seek to initiate discussions 

negotiations with Korea on an equivalency agreement in 2013 with the view to concluding an 

arrangement that will facilitate exports of U.S. organic products. 

Information Technology Equipment – Electrical Safety Regulations

U.S. industry has been working closely with KATS and the Radio Research Agency on the re-
72

organization of safety regulations for information technology equipment. The United States has 

advocated for streamlined procedures that reflect the realities of contemporary manufacturing 

and would provide an appropriate level of safety certification for low-risk information 

technology equipment, such as printers and computers. KATS amended its regulations in July 

2012, addressing many of the U.S. concerns, such as expanding the scope of products subject to 

a supplier’s declaration of conformity, and adopting the most current IEC standard. However, 

some concerns remain unaddressed. For example, the regulation does not allow for safety 

certifications to be made by a single multinational enterprise for all identical products; rather, 

the regulation requires separate certification with respect to each factory’s products. Currently, 

there is also no certificate renewal process. Furthermore, despite being a member of the IECEE 

CB scheme, KATS is not currently accepting CB reports without additional testing. 

We will continue to raise this issue with Korea in 2013.

Solar Panels – Testing Requirements 

Korea requires solar panels to be certified by the Korea Management Energy Corporation 

(KEMCO) before they can be sold in Korea in projects receiving government support (which 

means in practice the vast majority of sales). KEMCO’s certification standards prevent certain 

types of thin-film solar panels manufactured by U.S. industry from entering the Korean 

marketplace. For example, KEMCO has established a standard for thin film solar panels that 

can only be satisfied by panels manufactured from amorphous silicon. As a result, other leading 

types of thin film solar panels made by U.S. firms, including Cadmium Telluride (CdTe) and 

Copper Indium (di) Selenide (CIS), cannot be tested or certified under the Korean standard and 

thus remain shut out of most of Korea’s market. The United States urged Korea at the 2012 

bilateral trade consultations and at TBT Committee meetings to adopt the relevant international 

standard, IEC 61646, without limiting its application solely to the type of thin-film solar panel 

its industry produces. If Korea did so, it would both facilitate trade and afford Korean 

consumers access to the best available technologies. 

In response to U.S. concerns, Korea conducted an environmental impact review on the use of 

cadmium in solar panels, and determined that a hazard existed for using CdTe, while the hazard 

of CIS was relatively small. Korea has said it will consider developing a new certification 

standard for CIS based on the results of that study. U.S. industry has raised methodological 

concerns with the studies Korea used to disqualify CdTe. The United States will continue to 

raise this issue with Korea in 2013.

Motor Vehicle Parts - Safety Standards and Certification

In August 2011, Korea published draft regulations for comment, which mandated that specified 

replacement motor vehicle parts comply with Korea Motor Vehicle Safety Standards (KMVSS) 

and established a self-certification system for indicating compliance with the safety standards. 

The final regulation, promulgated in December 2011, reflected some of the comments submitted 

by the foreign automotive industry but did not reflect important requests related to the 

acceptance of parts certified to non-Korean standards. In April 2012, Korea published draft 

administrative guidelines, which contained implementation details for the new system and 

which raised additional concerns related to the allowable methods for marking the parts. The 

United States worked closely with Korea over several months on these proposed measures and 

U.S. concerns regarding use of non-KMVSS standards for parts and allowable methods for 
73

marking parts were resolved.

In 2013, we will continue to monitor the implementation of these measures.

Cellular Phones – Specific Absorption Rate (SAR) Labeling

In October 2012, Korea published and notified draft technical regulations that would establish 

two labeling categories for SAR levels (absorption of electromagnetic radiation) for mobile 

phones. Korea allows phones with a SAR level of 1.6 W/kg or less to be marketed in Korea. 

The proposed regulation, however, would establish two tiers within the allowable range: phones 

with a SAR of 0.8 W/kg or less would be labeled as “Level 1,” while phones with a SAR 

between 0.8 and 1.6 W/kg would be labeled “Level 2.” U.S. industry has submitted comments 

on the regulation raising concerns that there is no clear rationale or scientific basis for 

distinguishing between phones that meet the relevant safety regulation, and that the label could 

mislead, rather than inform, consumers by suggesting that there is a safety difference between 

the two categories. The United States has raised this concern with Korea in bilateral 

consultations and we will continue to do so 2013.

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. The United States 

and Malaysia also participate actively on standards and conformity assessment issues through 

APEC.

Meat and Poultry Products – Halal Standards

Malaysia requires all domestic and imported meat (except pork) to be certified as halal

(produced in accordance with Islamic practices) by Malaysian authorities. Malaysian 

regulations require producers’ halal practices to be inspected and approved for compliance with 

Malaysian standards on a plant-by-plant basis prior to export.

In January 2011, Malaysia implemented a food product standard – MS1500: 2009 – that sets out 

general guidelines on halal food production, preparation, handling, and storage. MS1500: 2009 

creates standards that go well beyond the internationally recognized halal standards, which are 

contained in the Codex Alimentarius. Specifically, the guidelines require slaughter plants to 

maintain dedicated halal production facilities and ensure segregated storage and transportation 

facilities for halal and non-halal products. In contrast, the Codex allows for halal food to be 

prepared, processed, transported, or stored using facilities that have been previously used for 

non-halal foods, provided that Islamic cleaning procedures have been observed.

In April 2011, Malaysia notified to the WTO its “Draft Malaysian Protocol for the Halal Meat 

and Poultry Productions.” The protocol provides additional information and guidance on 

complying with MS 1500: 2009. In May 2011, the United States provided comments on the 

protocol and subsequently raised concerns regarding the protocol during the June and November 

2011 TBT Committee meetings. Following that, Malaysia scheduled mandatory audits for 

establishments seeking to export to Malaysia. These audits took place in September 2012. The 
74

United States recently received notice from Malaysian officials that only one U.S. establishment 

passed the audit. All the other establishments failed the audits and are accordingly prohibited 

from exporting to Malaysia.

Additionally, in early 2012, Malaysia changed its pet food requirements such that porcine 

ingredients are now banned from food for cats, which many Malaysians keep as pets. Malaysia 

did not notify this change to the WTO, nor has Malaysia produced satisfactory justification for 

this prohibition, other than to indicate it will help consumers avoid purchasing products with 

porcine (i.e. non-halal) ingredients. Malaysia has not begun to enforce these requirements yet. 

The United States has suggested that Malaysia’s objectives could also be achieved through 

alternative measures such as labeling.

The United States will continue to pursue all halal related concerns with Malaysia in 2013.

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 and Mexico also engage on standards and 

regulatory issues in the NAFTA Committee on Standards-Related Measures, which met in 

February and October of 2012, and as part of the United States – Mexico High-Level Regulatory 

Cooperation Council, which was established in 2010, and issued a Work Plan in February 2012.

Energy Efficiency Labeling

In September 2010, Mexico’s Secretariat of Energy published the “Catalogue of equipment and 

appliances used by manufacturers, importers, distributors and marketers that require mandatory 

inclusion of energy consumption information.” The Catalogue was notified to the TBT 

Committee in June 2011 and imposes labeling obligations for manufacturers, importers, 

distributors, and marketers of those products. The labels to be placed on the products must 

contain information regarding the product’s energy efficiency and confirming that the product 

meets certain testing requirements. U.S. industry has raised concerns that the scope of the 

products subject to the catalog’s labeling requirements remains unclear. Accordingly, U.S. 

industry has requested that Mexico delay implementing the catalog until those issues are 

resolved. The United States raised these concerns with Mexico both bilaterally and in the June 

and November 2011 TBT Committee meetings. Furthermore, in 2012, the U.S. and Mexican 

governments met on numerous occasions to discuss how to better align the two countries’

energy consumption labeling regulations and energy efficiency policies.

Although the catalog entered into force in September 2011, it has not been enforced. Mexico 

did engage with U.S industry to clarify the catalog’s requirements. However, the United States 

will seek to identify product categories that can be removed from the catalog due to their de 

minimis energy consumption. The United States will continue to engage Mexico on this issue in

2013.

Sanitation Pipes – Standards

As noted in prior TBT Reports, the United States is concerned that Mexico’s National Water 
75

Commission (NWC) has not recertified U.S. producers of certain plastic pipe for waste water 

systems, drinking water systems, and domestic service connections, under the Mexican standard 

applicable at the time (NOM-001-CONAGUA-1995). 47 According to industry, NWC has 

instead sought to enforce an obsolete ISO standard on high density polyethylene (HDPE) plastic 

pipe, that is not incorporated into the Mexican standard and that relies on design and descriptive 

characteristics, rather than performance abilities. Furthermore, although both HDPE pipe and 

polyvinyl chloride (PVC) pipe – a competing product – cannot satisfy the design characteristics 

of the this ISO standard, NWC appears to only be enforcing this standard on HDPE pipe and not 

PVC pipe, the latter of which is manufactured predominantly by the domestic industry. Industry 

reports that HDPE pipe meets the standard contained in NOM-001-CONAGUA-199, as well as 

relevant performance characteristics as described in other, more up-to-date, state-of-the-art 

international standards.

The United States has raised this issue with Mexico both bilaterally and in the TBT Committee,

and continues to request that Mexico ensure that the standards NWC adopts are applied on a 

non-discriminatory basis, are science-based, and are developed through transparent processes as 

required by the TBT Agreement. Additionally, the United States has encouraged Mexico to 

apply the Mexican standard as written. On February 17, 2012, CONAGUA released an 

amended mandatory standard, NOM-001-CONAGUA-2011, which authorizes acceptance and 

use of standards that are utilized in the markets of Mexico’s trading partners, including the 

United States. Under this standard, U.S. pipe manufacturers, therefore, appear entitled to 

recertification under standards utilized in the United States, including ASTM International 

standards F2764, F2736, and F2947. However, despite accepting U.S. HDPE manufacturers’ 

requests for recertification and the completion of relevant testing, in February 2013, NWC stated 

that it still cannot recertify HDPE plastic pipe because NWC has been unable to confirm that 

ASTM International is an internationally recognized standard setting body, notwithstanding that 

the amended mandatory standard does not appear to limit the standards for recertification to 

only those produced by internationally recognized standards setting bodies and that ASTM 

International is generally recognized as an internationally recognized standard setting body.

Medical Device – Equivalency

In October 2010, Mexico published an executive order related to article 194B of the General 

Health Law 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. The Mexican 

regulator, Federal Commission for Protection Against Sanitary Risks (“COFEPRIS”) has had 

difficulties in implementing this process and has been working with industry to improve 

implementation. While some progress has been observed, numerous U.S. companies continue 

to complain about excessive wait times of one to two years for sanitary registration approval. 

47 Mexico has since amended NOM-001 several times. The most recent amendment, NOM-001-CONAGUA-2011, 

was notified to the WTO in February 2012. 
76

In October 2012, COFEPRIS announced the implementation of an agreement that will expedite 

the registration in Mexico of new pharmaceutical products already reviewed and approved by 

regulatory agencies in the United States, Australia, Canada, Switzerland and the EU. According 

to COFEPRIS, the agreement will promote public health in Mexico by giving Mexican 

consumers access to innovative pharmaceutical products approved for sale in the United States 

and elsewhere. In addition, COFEPRIS asserts that agreement will reduce from 360 days to 60 

days the approval time for certain drugs.

The United States will continue to monitor the implementation of the Agreement in 2013.

Vitamin Supplements – GMP Certification 

In August 2008, Mexico issued an administrative decree amending articles 168 and 170 of the 

Regulation for Health Supplies, which required Good Manufacturing Practices (GMP)

certification by Mexican certifiers for foreign companies that sought to sell pharmaceutical and 

nutritional supplements in Mexico. GMPs are production and testing practices meant to ensure 

the quality level of a product. In January 2010, U.S. officials requested that Mexico clarify its 

compliance requirements for vitamin supplements and other products marketed as nutritional 

supplements in the United States. Because the FDA does not issue export certificates to confirm 

compliance with GMPs for supplements, the United States has asked whether COFEPRIS would 

accept either a manufacturer’s self-declaration of GMP compliance or a GMP certificate issued 

by a third-party certifier. COFEPRIS has indicated it allows third party certification by 

COFEPRIS authorized certifiers or local/state authorities.48 The United States will continue to 

ask COFEPRIS to consider third-party certification by non-COFEPRIS authorized certifiers or 

perhaps conducting manufacturing facility inspections in the United States. 

Russian Federation

The Russian Federation is a Party to the Russia-Kazakhstan-Belarus Customs Union (CU) as 

well as the Eurasian Economic Community (EurAsEC). Technical regulations, standards, and 

conformity assessments systems in Russia are governed by the CU’s Eurasian Economic 

Commission, as well as at the national level. The CU Parties as well as the Members of 

EurAsEC have agreed to harmonize their policies and regulatory systems in the TBT arena. 

On August 22, 2012, Russia became the 156th Member of the WTO. Russia’s entry into the 

WTO brought the largest market outside of the WTO into the global trading regime’s rulesbased organization. Russia pledged to liberalize its trade regime to create an open and level 

playing field, thereby increasing its transparency and predictability. 

In 2012, the United States commented on the Ministry of Economic Development’s Decree on 

determining the criteria for notifying technical regulations and establishment of its WTO TBT 

Inquiry Point. In 2013, the United States will continue to emphasize the importance of timely 

notifications of draft technical regulations to the WTO, to ensure the availability of reasonable 

comment periods on draft regulations and reasonable implementation periods for final 

regulations, as well as a clear point of contact for each notification. 

48 State health departments in the United States do not issue GMP certificates for supplements.
77

Russia made its first two WTO TBT notifications on December 21, 2012. The first notification, 

by the Ministry of Industry and Trade, was “Amendments to the Technical Regulation of the 

Customs Union on Safety of Wheeled Vehicles,” and the second was the “EurAsEC Technical 

Regulation on Alcohol Product Safety”. The latter was notified only after a specific request by 

WTO Members, and did not provide a comment period. The United States will continue to urge 

Russia to be forthcoming in making its notifications to the WTO Secretariat for both technical 

regulations and amendments.

Bilateral Engagement 

The United States will work with Russia in the TBT Committee and bilaterally through the 

Business Development and Economic Relations Working Group (BDERWG) established under 

the United States – Russia Bilateral Presidential Commission. The BDERWG provides a forum 

for the United States and Russia to discuss, inter alia, standards-related regulatory cooperation. 

In 2013, the United States and Russia will look to increased engagement, as a matter of priority, 

in the area of standards and conformity, launching programs to understand better each other’s 

standards and regulatory structures, find areas for increased cooperation, and eliminate 

unnecessary obstacles to trade.

Food – Labeling Requirements

In October 2012 the Eurasian Economic Commission (EEC) of the CU published a revision to 

the “Technical Regulations on Food Products Labeling.” The revision imposes numerous 

labeling requirements, including with respect to nutritional components, allergens, and GE

foods. In addition, the revision requires that products containing sweeteners must carry a 

warning statement that overuse will cause digestive problems, and those products with food 

coloring must declare that it affects children’s ability to concentrate. This revision was not 

notified to the WTO. While implementation of these rules is scheduled for July 1, 2013, the 

EEC will allow products labeled under the previous regulations to circulate in the market until 

February 15, 2015. The United States sent comments to the EEC in December 2012. The 

comments expressed concern that the revised regulations require labeling for GE products and 

nutritional components beyond the recommended guidelines established in the Codex General 

Standard for Food Labeling. Additionally, the United States noted that the requirements for 

labeling of allergens in food are unclear. These claims are not based on the latest scientific 

research nor do they appear consistent with the Codex. The United States has not received a 

response to its December 2012 comments. In 2013, the United States will continue to engage 

the EEC in 2013 to resolve outstanding concerns.

Alcoholic Beverages – “Strip Stamps”

As noted in last year’s TBT Report, Russia levies excise taxes on alcohol and enforces these 

taxes through a system that requires alcohol beverage containers to bear an excise “strip stamp” 

label. Over the last year U.S. industry has reported some positive improvements with respect to 

Russia’s strip stamp requirements, including advanced notice and comment of requirements and 

a more effective transition from the use of old stamps to new stamps with an adequate grace 

period and functioning electronic registration. 
78

Alcoholic Beverages – Conformity Assessment Procedures, Standards, and Labeling 

The EEC revised its “Technical Regulation on Alcoholic Product Safety” in November 2012, 

and included some positive changes, including removing a requirement mandating the aging of 

rums and reducing the size of the warning statement to allow for other consumer and branding 

information on containers.

However, the United States still has significant concerns with the EEC draft “Technical 

Regulation on Alcoholic Product Safety” which is proposed to enter into force in July 2013. 

Most notably, the proposed measure would impose duplicative conformity assessment 

procedures, administered by at least three different government authorities, all of which appear 

to have the same objective of data registration. Specifically the proposed requirements call for a 

new alcohol beverage notification procedure to be administered in Russia by the Federal Service 

for the Regulation of the Alcohol Market. U.S. industry is concerned that the multiple 

conformity assessment procedures administered by different agencies add an unnecessary level 

of complexity leading to increased costs and time delay. Furthermore, the United States is 

aware that Russia, outside of the work of the EEC, has passed a law (Amendment SF171) which 

contains another similar notification procedure for alcoholic beverages. It is scheduled to go 

into effect on March 1, 2013. The United States has requested that Russia postpone 

implementation of SF171.

The EEC “Technical Regulation on Alcoholic Product Safety”, also introduces burdensome and 

unique requirements to label all alcoholic beverages, with an expiration date, or include a label 

indicating that “the expiry date is unlimited if the storage conditions are observed.” U.S. 

industry notes that the proposed requirement does not provide accurate or beneficial information 

for products containing more than 10 percent alcohol, because these products do not 

expire. Furthermore, the proposed expiration date requirement appears inconsistent with 

international guidelines – particularly with Article 4.71(vi) of the Codex General Standard for 

the Labeling of Prepackaged Foods, which exempts beverages containing 10 percent or more by 

volume of alcohol from such date-marking requirements. The United States will encourage 

Russia to eliminate this requirement for alcoholic beverages containing more than 10 percent 

alcohol by volume, and urge Russia to adopt international standards or guidelines.

The proposed technical regulation gives rise to other issues that could affect U.S. exports of 

alcoholic beverages, including unclear definitions for wine and wine beverages and a 

requirement that whiskey be aged no less than three years. In February 2013, the United States 

provided comments the EEC and will continue to work with Russia on this matter.

Alcoholic Beverages - Warehousing Requirements 

The United States has been engaged with Russia on its storage requirements for alcoholic 

beverages. Those storage requirements are set forth in Regulation Order #59n. As a result of 

bilateral discussions that took place in 2011, Russia issued a revised regulation in 2012, which 

offered some improvements, such as the removal of the requirement that pallets be 15 mm high 

from the floor. However, outstanding issues remain. For example, the United States seeks 

clarification regarding the specificity of warehouse construction requirements, the stringency of 

warehouse inspections, and temperature controls, which appear to exceed international 

standards. The United States provided comments to Russia in August 2012. As of February 

2013, the United States has yet to receive a response. The United States also raised concerns in 
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the WTO about the revised requirements with Russia during the November 2012 TBT 

Committee, and urged Russia to provide timely and transparent inspections, because distilled 

spirits manufacturers continue to experience costly delays awaiting inspection approvals. 

South Africa

Bilateral Engagement

The United States and South Africa discuss TBT matters during TBT Committee meetings, 

bilaterally on the margins of these meetings, and under the United States – South Africa Trade 

and Investment Framework Agreement. USDA and the South African Department of 

Agriculture, Forestry and Fisheries (DAFF) discuss TBT matters through their annual bilateral 

forum in Pretoria, South Africa.

Liqueurs – Alcohol Content Restrictions

In 2009, U.S. industry expressed concerns about South Africa’s classification of alcoholic 

beverages. Alcoholic products cannot be sold in South Africa unless they fall within a 

designated classification, which is determined in part by alcohol content. 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 (ABV). South Africa does 

not maintain any classification for spirit-based alcoholic beverages with an alcohol 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, or 

“Cocktail/Aperitif” classification, beverages based on herbs or other flavorings of vegetable 

origin that differ from wine with alcohol volume content between 15 and 23 percent by volume.

As a result, any U.S. products that fall in the gap between the “liqueur” and “spirit cooler” 

classifications, and outside the Cream Liqueur or Cocktail/Aperitif classification, 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. importers have reported that South Africa granted at least 

one exception to a domestic product containing 15-23 percent alcohol level by volume.

During 2013, the United States will continue to raise concerns regarding South Africa’s 

alcoholic beverage standards and, if appropriate, will urge South Africa to eliminate or modify 

its “liqueur” definition, or seek another solution that facilitates trade, such as an exemption, 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 as well as under the auspices of the United States –

Taiwan Trade and Investment Framework Agreement (TIFA).
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Ceiling Panels – Requirements for Incombustibility Testing Methods

As discussed in the 2012 TBT Report, U.S. companies that manufacture finished interior 

building materials, such as ceiling panels and wood paneling, continue to raise concerns 

regarding the testing method that Taiwan mandates for determining whether those materials 

meet applicable incombustibility requirements. According to U.S. industry, Taiwan’s present 

measure gives U.S. ceiling tiles a lower incombustibility rating than is otherwise warranted. In

some instances, U.S. ceiling tiles unreasonably fail the test altogether. The reason the testing is 

problematic according to U.S. industry is that Taiwan’s measure applies a variation of the ISO 

5660 standard for Reaction to Fire Tests - Heat Release, Smoke Production and Mass Loss Rate,

which at the time was not complete; however, U.S. industry notes that a recent revision of the 

ISO standard incorporated additional guidelines that will ensure better and more reliable 

incombustibility ratings and should therefore be adopted by the Taiwan authorities as soon as 

possible. In October 2012, USTR urged Taiwan to adopt the ISO committee’s revised standard. 

USTR continues to monitor Taiwan’s process in adopting a standard mirroring the revised ISO 

5660 (released in January 2013 as ISO 5660-3). 

Commodity Goods – Labeling Requirements

As discussed in the 2012 report, the United States raised concerns that Taiwan requires all

“commodity goods” (consumer goods) to be labeled with the manufacturer’s or producer’s name, 

telephone number, and address. In addition to concerns over protecting proprietary information 

under the requirements of such labeling, industry notes that some commodity goods are 

produced by several different manufacturers and product labels may not be large enough to 

contain all of the required information. This measure imposes costs for firms, including the cost 

of developing unique labeling requirements for the Taiwan market.

U.S. officials have raised these concerns with Taiwan’s representatives, including on the 

margins of the TBT Committee meetings as well in staff-level meetings under the TIFA. We 

will continue to monitor this issue in 2013.

Product Multipacks – Labeling Requirements 

U.S. industry has raised concerns over a reinterpretation by Taiwan’s Ministry of Economic 

Affairs (MOEA) of its “Commodity Inspection Act” and “Commodity Labeling Act” in 2006 to

require all units included in a retail multipack to be labeled for individual sale, even if the 

retailer will not divide up the multipack for sale as single units. U.S. suppliers have asserted 

that this requirement imposes unnecessary additional costs as it forces them to add additional 

labels on their products to continue exporting to Taiwan. 

U.S. officials raised this issue with their Taiwan counterparts during TBT Committee meetings 

and most recently in an October 2012 TIFA working-level meeting. Taiwanese officials 

responded that Taiwanese consumers typically purchase bulk items such as socks in individual 

units rather than multipacks and therefore that individual units included in multipacks must be 

labeled to avoid the risk of fraudulent country of origin labeling. U.S. officials requested that 

Taiwan notify the WTO of its revised labeling rules to provide an opportunity for WTO 

Members to submit comment. MOEA has yet to do so.
81

Turkey

Bilateral Engagement

The United States discusses TBT matters with Turkey during, and on the margins of, TBT 

Committee meetings, in meetings of the Council established under the United States – Turkey 

Trade and Investment Framework Agreement (TIFA), in United States – Turkey Economic 

Partnership Commission (EPC) talks, and in the bilateral cabinet-level Framework for Strategic 

Economic and Commercial Cooperation (FSECC). The FSECC is designed to reinforce the 

work of the EPC and TIFA and provide political-level guidance on particularly challenging 

commercial and economic issues.

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 to secure a Good Manufacturing Practice 

(GMP) certificate based on a manufacturing plant inspection by Turkish Ministry of Health 

(MOH) officials, before their products can be authorized for sale in Turkey. 

The United States, although it does not oppose MOH inspection requirements for 

pharmaceutical manufacturing facilities, has concerns with respect to this measure. Specifically, 

the United States is concerned that Turkey did not publish or notify this regulation to the WTO. 

In addition, the United States is concerned that Turkey no longer accepts U.S. FDA’s GMP 

certifications, and that pharmaceutical producers face significant delays in meeting the 

inspection requirements because of the MOH’s extensive backlog of GMP inspections. In the 

February 2013 bilateral Trade and Investment Framework Agreement meeting, Turkey stated 

that it would consider amending its regulatory practices in order to allow MOH’s review of the 

pharmaceutical product dossier to take place concurrently with the pharmaceutical producer’s 

process of obtaining GMP certification.

While we still need to monitor progress in 2013, this is potentially a significantly positive step, 

which the United States encouraged using various engagement opportunities in 2012. 

Food and Feed Products – Mandatory Biotechnology Labeling 

In 2009, Turkey’s Ministry of Agriculture published a regulation governing biotechnology in 

food and feed. The measure was not publicly announced or notified to the WTO in advance of 

entry into force, and contained no phase-in period. Turkey has since published several 

amendments to the regulation and later superseded this regulation with the enactment of the 

“Biosafety Law,” which was notified to the WTO. This Law became effective in September 

2010 and mandates the labeling of ingredients derived from biotechnology in all food and feed if 

the biotechnology content exceeds a certain threshold, a requirement that impedes U.S. food and 

feed exports to Turkey. In addition, Turkey’s Biosafety Law goes beyond mandatory methodof-production labeling, which refers to the mandatory labeling that a product or ingredient in a 

product was produced using biotechnology. The labeling requires that “GMO” labels on food 

should contain health warnings if the biotechnology food differs from the non-biotechnology 

food.
82

This labeling requirement raises additional concerns because it appears to presume, incorrectly,

that food containing biotechnology products is inherently more risky from a health perspective 

than its non-biotechnology food counterpart. Consequently, such health warnings could 

unnecessarily cause public alarm while providing no additional public health protection. For 

example, changes in edible 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 food safety.

In addition to the labeling requirement, the Biosafety Law mandates strict traceability for all 

movement of biotechnology feed and includes onerous requirements for each handler to 

maintain traceability records for 20 years. The United States has engaged bilaterally with 

Turkey in the margins of the TBT Committee meetings on issues related to Turkey’s Biosafety 

Law. The United States will continue bilateral talks on these issues with Turkey in 2013.

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 United States

– Vietnam TIFA Council meetings. The United States also works with Vietnam in advancing 

standards and conformity assessment issues through ASEAN and APEC.

Food Safety Law – Registration Requirements for Processed Foods

The United States has concerns regarding Decree 38, the implementing regulation for Vietnam’s 

Food Safety Law, which was signed into law in June 2012. The measure was notified to the 

SPS Committee in March 2011, and was notified to the TBT Committee in December 2012. 

Under the measure, exporting manufacturers of prepackaged processed foods, food additives

and food packaging materials must complete numerous forms and certificates to obtain 

affirmations of the product’s conformity to Vietnamese laws and regulations. Products without 

these conformity assessments may not be exported to Vietnam.

Although the implementation date for Decree 38 was June 11, 2012, implementation has been 

gradual as the various ministries involved sort out their responsibilities and enforcement 

activities. The United States, along with other WTO Members, has requested that enforcement 

of the Decree, as well as any subsequent implementing regulations, be delayed until the specific 

concerns of the United States and other trading partners can be fully addressed.

At the June 2012 TBT meeting, the United States raised concerns about Decree 38 with support 

from Australia, the EU, New Zealand, Canada, and Chile, and also submitted extensive written 

comments and technical questions to Vietnam at that time. The United States continued to raise 

concerns with Vietnam over Decree 38 throughout 2012, both at the November 2012 TBT 

meeting and in Hanoi. 

The United States will continue to monitor the issue and raise concerns with Vietnam in 2013.
83

XII. Appendix A: List of Commenters

1. Almond Board of California

2. American Potato Trade Alliance

3. American Soy Bean Association

4. California Table Grape Commission

5. Distilled Spirits Council of the United States

6. Grocery Manufacturers of America

7. Herbalife

8. National Confectioners Association

9. National Potato Council

10. North American Export Grain Association

11. Royal Thai Government

12. Toy Industry Association

13. Underwriters Laboratories

14. U.S. Dairy Export Council & National Milk Producers Federation

15. U.S. Wheat Associates

16. Yum! Restaurants International

85

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
86

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

USDA U.S. Department of Agriculture

USITC U.S. International Trade Commission

USTR Office of the United States Trade Representative

WTO World Trade Organization
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE

EXECUTIVE OFFICE OF THE PRESIDENT

WASHINGTON, D.C. 20508