ACKNOWLEDGEMENTS

The Office of the United States Trade Representative (USTR) is responsible for the preparation 

of this report. U.S. Trade Representative Ron Kirk gratefully acknowledges 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. 

March 2012
i

TABLE OF CONTENTS

I. Foreword ............................................................................................................................1

II. Executive Summary...........................................................................................................3

III. Introduction........................................................................................................................5

Genesis of this Report........................................................................................................ 5

Central Focus in 2011 ........................................................................................................ 6

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

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

TBT Agreement ................................................................................................................. 9

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

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

Recent U.S. Initiatives to Prevent Unnecessary Obstacles to Trade................................ 31

Emerging Technologies ....................................................................................... 31

Engagement in Voluntary Standards Activities................................................... 32

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 ..................................................................................................... 34

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

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

Asia Pacific Economic Cooperation ................................................................................ 37
ii

2011: The U.S. APEC Year ................................................................................ 37

Good Regulatory Practices................................................................................... 38

Smart Grid............................................................................................................ 39

Green Buildings ................................................................................................... 39

Solar Technologies............................................................................................... 40

Information and Communication Technologies .................................................. 40

Food Safety .......................................................................................................... 41

Wine Regulatory Forum ...................................................................................... 42

Trans-Pacific Partnership................................................................................................. 42

CAFTA-DR...................................................................................................................... 43

Regulatory Cooperation Fora........................................................................................... 43

European Union ................................................................................................... 44

Mexico ................................................................................................................. 44

Canada.................................................................................................................. 45

Doha Round Negotiations.................................................................................... 45

X. Trends in 2011 .................................................................................................................47

Regulatory Measures on Goods with Cryptographic Capabilities................................... 47

Mandatory Labeling of Genetically Engineered Foods................................................... 47

Alcoholic Beverage Regulations...................................................................................... 48

Organic Product Standards .............................................................................................. 49

Formula Disclosure Requirements................................................................................... 50

Documentation Requirements.......................................................................................... 51

Voluntary” Measures as Trade Barriers........................................................................... 52

XI. Country Reports...............................................................................................................54

Background on Specific Trade Concerns Contained in the Country Reports.................. 54

Argentina.......................................................................................................................... 54
iii

Brazil................................................................................................................................ 55

Chile................................................................................................................................. 59

China ................................................................................................................................ 60

Colombia.......................................................................................................................... 67

Central American Customs Union (CACU) .................................................................... 68

The European Union ........................................................................................................ 69

India ................................................................................................................................. 73

Indonesia .......................................................................................................................... 77

Japan ................................................................................................................................ 78

Kenya ............................................................................................................................... 79

Korea................................................................................................................................ 79

Malaysia........................................................................................................................... 82

Mexico ............................................................................................................................. 83

Russia............................................................................................................................... 85

Saudi Arabia..................................................................................................................... 86

South Africa ..................................................................................................................... 87

Taiwan.............................................................................................................................. 88

Thailand ........................................................................................................................... 88

Turkey.............................................................................................................................. 90

Vietnam............................................................................................................................ 91

XII. Appendix A: List of Commenters...................................................................................93

XIII. Appendix B: List of Frequently Used Abbreviations and Acronyms.............................95
1

I. Foreword

This year the Office of the United States Trade Representative (USTR) publishes its third 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 unjustifiable barriers to trade and to prevent their emergence. Indeed, 

in 2011 USTR secured several important additions to the arsenal of tools at its disposal to 

combat unnecessary trade barriers and made progress on the addition of others, including: 

passage of free trade agreements with Korea, Colombia, and Panama that strengthen our ability

to ensure that the standards-related measures these trading partners adopt are transparent and 

serve legitimate objectives; the creation of new cooperation initiatives related to regulatory and 

standards issues in the WTO, APEC, U.S. FTAs, and other bilateral fora; and 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 current TBT disciplines. 

As part of the U.S. host year for APEC in 2011, USTR led several initiatives to promote the use 

of good regulatory practices across the Asia Pacific region and to prevent governments from 

creating standards-related barriers to trade in emerging technologies of critical importance to the 

United States – including in the areas of “smart grid,” solar technologies, and commercial green 

buildings. At the APEC CEO Summit in Honolulu, President Obama highlighted the 

importance of these initiatives for regulatory convergence, which he said will permit countries 

“to all think about whether our regulations are as efficient, as effective as they can be, or where 

are they standing in the way of smart trade.

1

” USTR also took successful steps to eliminate or 

reduce potential foreign technical barriers to U.S. exports in 2011, for example, by working with 

Chile to ensure that diesel emissions standards in Chile continue to allow U.S.-manufactured 

commercial diesel trucks to be sold in the Chilean market.

 1

 See http://www.whitehouse.gov/the-press-office/2011/11/12/remarks-president-obama-apec-ceo-businesssummit-qa. 
2

Again in 2012, 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 

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 Ron Kirk

U.S. Trade Representative

March 2012
3

II. Executive Summary

The 2012 Report on Technical Barriers to Trade (TBT Report) is a specialized report focused on 

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

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

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

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

shaping the flow of global trade. 

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

enabling greater access to international markets by SMEs. Standards-related measures also 

enable governments to pursue legitimate objectives such as protecting human health and the 

environment and preventing deceptive practices. But standards-related measures that are nontransparent, discriminatory, or otherwise unwarranted can act as significant barriers to U.S. 

trade. These kinds of measures can pose a particular problem for SMEs, which often do not 

have the resources to address these problems on their own. 

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

barriers. The report is comprised of the following key components:

• An overview of technical barriers to trade and the U.S. and international mechanisms for 

addressing them (Sections I-II);

2

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

the growing importance of standards-related measures in global trade (Section III);

• 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);

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

obligations (Section V);

• 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);

• 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);

 2

 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

• 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);

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

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

multilateral, regional, and bilateral channels, including the WTO’s Committee on 

Technical Barriers to Trade (TBT Committee) and cooperative activities under the 

APEC Subcommittee on Standards and Conformance, among others (Section IX); 

• A summary of current trends relating to standards-related measures (Section X); and

• An identification and description of significant standards-related trade barriers currently 

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

impact of these barriers (Section XI) in 19 countries – Argentina, Brazil, China, Chile

Colombia, India, Indonesia, Japan, Kenya, Korea, Malaysia, Mexico, Russia, Saudi 

Arabia, South Africa, Taiwan, Thailand, Turkey, and Vietnam – as well as the Central 

American Customs Union (CACU), and the European Union (EU).
5

III. Introduction

Genesis of this Report

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

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

trading rules. The President vowed an aggressive and transparent program of defending U.S. 

rights and benefits under the rules-based trading system as a key element in his vision to restore 

trade’s role in leading economic growth and promoting higher living standards. The President

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, the latter of 

which are also known as “technical barriers to trade” (TBT). 

Accordingly, in 2009 Ambassador Kirk directed USTR to create a new Report on Sanitary and 

Phytosanitary Measures (SPS Report) and a Report on Technical Barriers to Trade (TBT 

Report). 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 dedicated to significant foreign barriers in the form of 

product standards, technical regulations, and conformity assessment procedures (standardsrelated measures). Prior to 2010, standards-related measures were addressed by the National 

Trade Estimate Report on Foreign Trade Barriers (NTE Report).3 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 (2012 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 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 address standards-related 

measures when they act as unnecessary barriers to trade. This general information is provided 

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

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

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

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

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

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

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

intellectual property rights.
6

to assist the reader in understanding the issues and trade concerns described in the last two 

sections of the report, as well as the channels for resolving them. These last two sections review 

current trends relating to standards-related measures that can have a significant impact on trade 

and identify and describe significant standards-related trade barriers currently facing U.S. 

producers and businesses, along with U.S. government initiatives to eliminate or reduce these 

barriers. 

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

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

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

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

submitted comments in response to the Federal Register notice.

Central Focus in 2011

During 2011, the United States succeeded in prompting its trading partners to reduce or 

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

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

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

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

good regulatory practices. In 2011, the United States also proposed new initiatives in key trade 

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

prevent unnecessary technical barriers to trade. 

Overview of Standards-Related Measures

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

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

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

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

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

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

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

gained prominence in international trade because of a desire to:

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

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

global supply chains;

• organize manufacturing or other production processes around replicable routines and 

procedures to yield greater product quality assurance;

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

preventing deceptive practices, and protecting the environment; and 
7

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

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

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

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

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

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

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

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

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

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

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

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

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

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

markets. 

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

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

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

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

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

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

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

with those requirements, and help goods flow across borders.

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

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

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

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

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

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

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

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

agreements are described in more detail in Section 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 

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

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

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

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

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

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

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

These efforts are designed to ensure that U.S. trading partners adhere to internationally-agreed 
8

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.
9

IV. Overview of Trade Obligations on Standards-Related Measures

TBT Agreement

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

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

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

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

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

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

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

assessment procedures are fair and reasonable. 

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

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

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

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

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

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

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

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

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

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

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

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

Box 2. Key principles and provisions of the TBT Agreement

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

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

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

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

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

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

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

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

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

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

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

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

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

requirements. (Art. 5.1.2)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Art. 6.3)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

provides for disputes under the Agreement to be resolved under the auspices of the WTO Dispute Settlement Body 
11

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

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

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

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

inquiry point that is able to answer reasonable questions from other Members and interested 

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

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

adopts are promptly published or otherwise made publicly available. 

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

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

that standards-related measures do not become unnecessary obstacles to trade.4 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.5 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.6

 4

 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.

 In 2011 alone, 

5 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. 

6 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. 

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.
12

WTO Members notified 1,217 new or amended technical regulations and conformity assessment 

procedures to the WTO. Box 3 shows the number of notifications yearly since 1995.7 

Box 3. Number of TBT Notifications since 1995

Source: G/TBT/31

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

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

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

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

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

the TBT Committee are described in detail below.

Operation of the TBT Agreement

The TBT Agreement 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, adhere to the 

 7 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).

0

200

400

600

800

1000

1200

1400

1600

1800

2000

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

Notifications Addenda/Corrigenda
13

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

policies, and procedures it has adopted to implement and administer the TBT Agreement.8

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

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

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

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

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

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

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

government will consider alternative technical specifications that may lessen any potential 

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

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

in global 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. In 

some developing countries, ineffective internal coordination and a lack of established 

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

technical assistance or cooperative efforts to improve internal coordination can be vital in 

helping U.S. exporters sell into these markets.

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

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

for implementing specific obligations.9

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

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

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

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

perhaps even help to resolve the concerns. In 2011, WTO Members raised over 60 specific 

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

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

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

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

 8 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. 

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

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.10

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

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

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

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

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

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

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

accounting of the concerns raised in the Committee since 1995, see G/TBT/31.

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

(Source: WTO, G/TBT/31)

In 2011, the Committee also conducted a final formal review of how well China has 

implemented the TBT commitments it undertook when it joined the WTO in 2001. (China’s 

membership agreement included a “Transitional Review Mechanism” requiring eight annual 

reviews on a range of subjects, including TBT, with a final review after 10 years.) Several 

members of the Committee, including the United States, raised concerns regarding the 

implementation of China’s commitments, particularly with respect to issues relating to lack of 

 10 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.
15

both transparency and the use of good practices in China’s standardization and regulatory 

systems, and expressed serious concerns with China’s compulsory certification system.11 

Also in 2011, the Committee agreed to test a proposed way 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 repetitive, leaving less time for the Committee to address the systemic issues needed to 

prevent and resolve trade issues. 

Standards-Related Provisions in U.S. Free Trade Agreements12

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

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

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

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

coordination with FTA partners on systemic issues. As a result, the U.S. approach to standardsrelated measures in its FTAs is commonly referred to as “TBT plus.”13 U.S. FTAs, for example,

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

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

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

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

monitor each other’s proposed measures more closely. 

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

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

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

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

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

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

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

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

conformance infrastructure, these consultative mechanisms can enable early identification of 

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

 11 See G/TBT/M/55 pages 64-71 for the minutes of the TBT Committee’s discussions under China’s final TRM. 12 This section describes TBT provisions of U.S. FTAs with Australia, Bahrain, Central America and the 

Dominican Republic, Chile, Morocco, Oman, and Peru, all of which were concluded in 2003 or later. Pending 

FTAs with Panama and Colombia, as well as the recently implemented U.S. FTA with Korea, contain similar TBT 

provisions. In addition to these FTAs, the NAFTA also includes provisions that go beyond those contained in the 

TBT Agreement, for example, with respect to transparency, cooperation with trading partners regarding standardsrelated measures, and national treatment for testing and certification bodies. The U.S. FTA with Singapore also 

includes TBT provisions that seek to enhance the parties’ cooperation on standards-related measures. 

13 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

alternatives before a measure is finalized.14 The provisions in U.S. FTAs that provide for more 

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

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

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

FTA partners whose standards and conformance infrastructure is underdeveloped or is otherwise 

in need of improvement. 

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

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

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

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

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

equivalent to their own, where appropriate.

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

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

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

Standards.

15

G/TBT/W/305

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

. These issues are discussed in more detail in Section V below.

In 2011, the United States advanced work towards concluding the broad outlines of an 

agreement with eight Asia Pacific trading partners through the Trans-Pacific Partnership (TPP) 

negotiations. As these negotiations continue towards conclusion in 2012, the United States is 

pursuing an active agenda with regard to TBT and standards-related issues, aiming to identify 

further opportunities to “raise the bar” in this area through effective TPP provisions. Further 

details on the TPP are provided in Section (IX) below.

 14 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.

15 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

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

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

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

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

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

provisions as well.

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

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

procedures.

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

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

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

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

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

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

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

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

conformity assessment body.

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

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

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

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

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

measure; that 60 days be allowed for comment, where possible; that proposals be published or otherwise made 

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

that additional information be provided about the objectives when requested.

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

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

specific issues or sectors.

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

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

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

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

on pertinent developments.

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

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).16 The APA establishes a process of public participation in 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

comments into account in the final rule.

17 In accordance with the APA, agencies publish 

proposed technical regulations and conformity assessment procedures and solicit public 

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

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

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

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

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

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

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

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

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

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

II, Technical Barriers to Trade (Standards). 

17 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

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,

18 such as that embodied in E.O. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

retrospective analysis of existing rules. 

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

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

Circular A-119, require Federal agencies to use19 voluntary consensus standards20

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

in their 

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

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

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

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

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

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

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

20 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. 
21

regulatory activities wherever possible and to avoid using “government-unique” standards.21 

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

suitable voluntary consensus standards already exist. Voluntary consensus standards can often 

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

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

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

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

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

principles such as openness, transparency, and consensus.

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

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

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

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

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

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

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

Reducing Technical Barriers to Trade.

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

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

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

standards can facilitate buyer-seller transactions, spur competition22 and innovation, increase the 

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

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

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

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

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

products and complex processes resides.23

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

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

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

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

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

and participation in the development of international standards. 

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

conformity assessment procedures on relevant international standards, guides and 

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

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

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

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

from developing standards where international standards already exist.

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

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

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

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

24

 22 See 

 The 2000 

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

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

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

Through Effective Collaboration, International Trade Administration, 2005.

23 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. 

24 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 are contained in document G/TBT/1/Rev.10.
24

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.25 For 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

requirements mirror the 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. 

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

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

standards developing organizations consistent with agency missions and priorities. The 

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

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

standards development activities of 497 organizations26

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

to support regulatory needs, enable 

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

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

G/TBT/W/305. 

26 Source: NIST, 2008.
25

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.

27

VII. Conformity Assessment Procedures

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

that products sourced in global market meet specific requirements.27 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.

28 

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.29

G/TBT/1/Rev.10

Indeed, 

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

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

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

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

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

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

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

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

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

.

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

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

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

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

providing guidance to Federal agencies on conformity assessment. 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. 

 27 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.

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

Assessment System, NIST, 1997. 

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

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

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

the “CASCO toolbox.”30

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

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

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

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

products in international markets through the use of competently conducted conformity 

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

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

assessment in facilitating international trade.

Participation and use of international systems of conformity assessment strengthens these 

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

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

convenient to production facilities and reducing duplicative testing and certification 

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

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

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

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

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

markets.

Examples of international accreditation systems include the International Laboratory 

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

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

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

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

accreditation bodies that participate in these mutual recognition arrangements are predominately 

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

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

ILAC in support of their conformity assessment requirements.

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

 
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 all 

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 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, NIST 

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

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

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

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

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

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

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

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

agencies on their behalf. 

In 2011, NIST’s U.S. TBT Inquiry Point and Notification Authority processed and distributed 

over 59,000 information requests, including over 2,500 requests for information on standards 

and over 57,000 requests related to technical barriers to trade. The office distributed 132 U.S. 

government and industry comments to other WTO Members, and circulated 13 WTO Member 

comments on U.S. measures, as well as 28 WTO Member replies to U.S. comments, to relevant 

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

WTO Members in sectors of interest through the Notify U.S. early alert program, and contact 
30

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

contribute to the submission of U.S. comments, and to coordinate follow-up actions. NIST’s 

Inquiry Point and Notification Authority hosted or participated in training for six U.S. and 

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

stakeholders monitor notifications of new or revised measures of other WTO Members in 

sectors of interest through the Notify U.S. early alert program, and contact U.S. officials through 

the government channels listed above to obtain further information, to contribute to the 

submission of U.S. comments, and to coordinate follow-up actions. NIST’s Inquiry Point and 

Notification Authority hosted or participated in training for six U.S. and foreign visiting 

delegations interested in learning how a WTO inquiry point operates. 

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 assembles teams of specialists to investigate market access 

problems, including those involving standards-related measures, as well as develop strategies to 

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

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

In addition, the Department regularly provides input to the TPSC 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-theground 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 nonagricultural 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 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 prevent agriculture-related issues arising from foreign 

standards-related measures.

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

the Industry and Agriculture Trade Advisory Committees (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.31 

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. 

Recent U.S. Initiatives to Prevent Unnecessary Obstacles to Trade

Emerging Technologies

Emerging technologies often have significant scientific, economic, and even societal impacts as 

they revolutionize fields as varied as materials science, electronics, medicine, communications,

agriculture, and energy. Emerging technologies also often result in the creation of new products 

and processes with unique characteristics, which governments must decide how to regulate. As 

governments make decisions about regulating emerging technologies, it is essential that they 

coordinate across the different agencies that may have oversight over the new products and 

technology to ensure that the economic and public benefits of these emerging technologies and 

the new products and processes they create are fully realized. 

In March 2011, the Emerging Technologies Interagency Policy Committee (ETIPC), which 

consists of USTR, OIRA and OSTP released a joint memorandum to U.S. federal government 

agencies, entitled “Principles for Oversight and Regulation of Emerging Technologies,” that 

provides guidance to agencies to ensure that their regulatory approach to areas of emerging 

technologies is coordinated and avoids regulatory and oversight approaches that unjustifiably 

inhibit innovation, stigmatize new technologies, or create trade barriers. Additionally, the 

ETIPC developed a set of U.S. government principles specific to the regulating nanotechnology 

and nanomaterials. The trade facilitative U.S. regulatory approach demonstrated by these 

principles provides an important model as our trading partners seek to regulate emerging 

technologies. 

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

 
32

Engagement in Voluntary Standards Activities 

Standards help enable technological innovation by defining and establishing common 

foundations upon which product differentiation, innovative technology development and other 

value-added services may be developed. Standards are also essential for enabling seamless 

interoperability between and across products and systems. In the United States, standards 

development is led by the private sector and highly informed by market needs. In areas relevant 

to their agency objectives, federal government agencies also engage in standardization in limited 

circumstances when necessary to encourage 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.” The memorandum emphasizes the strengths 

of the U.S. standards model of private sector leadership and articulates principles for federal 

agencies to follow when agencies are tasked with a coordination or convening role. The 

memorandum establishes four principles to guide agencies in their engagement in standards to 

meet U.S. priorities, and directs agencies to ensure certain objectives are met, including (1) 

achieving cost-efficient, timely, and effective solutions to legitimate regulatory, procurement, 

and policy objectives; (2) promoting standards and standardization systems that promote and 

sustain innovation and foster competition; (3) enhancing U.S. growth and competitiveness and 

ensure non-discrimination, consistent with international obligations; and (4) facilitating 

international trade and avoid the creation of unnecessary obstacles to trade. Here again, the U.S. 

approach to Federal engagement in standards development provides a trade facilitative model 

for our trading partners as they engage in standards development.
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 maintains a broad and active agenda of engagement with foreign governments 

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

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

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

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

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

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

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

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

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

facilitating trade. 

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

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

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

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

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

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

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

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

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

United States provides bilateral technical assistance and capacity building to developing 

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

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

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

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

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

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

To reduce the negative impact on trade from divergences in technical requirements across 

markets, the United States negotiates bilateral, regional, and multilateral 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.

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

United States is a party. It also maintains a listing of the accreditation requirements for 
34

conformity assessment bodies under each of these MRAs and a list of conformity assessment 

bodies that NIST has designated pursuant to each MRA as competent to perform tests or certify 

products to ensure they conform to the other MRA party’s technical requirements. (The Federal 

Communications Commission (FCC) website provides useful background information on U.S. 

MRAs in the telecommunications sector and examples of how they work.) 

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

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

determinations with Canada on organic agricultural products. As a result of that exchange, U.S. 

producers that a USDA-accredited agent certify as meeting U.S. National Organic Program 

standards do not need to be certified under the Canada’s National Organic Standard in order to 

market their products in Canada as “organic.” The exchange provides for Canadian producers to 

receive a similar accommodation for products they export to the United States. On February 15, 

2012, the United States signed an organics equivalence arrangement with the European Union. 

The new partnership allows for organic products certified in Europe or in the United States to be 

sold as organic in either market, without additional certification. This arrangement between the 

world’s two largest organic producers will establish a strong foundation from which to promote 

organic agriculture, benefiting the growing organic industry and supporting jobs on a global 

scale. The United States continues to work with Korea and Japan to open their organic markets 

to U.S. organics as well.

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

The U.S. government actively seeks to prevent and eliminate unnecessary technical barriers to 

trade through the focused WTO Member-driven agenda of the 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 2011, the United States raised specific trade concerns regarding 20 to 30 foreign TBT 

measures at each TBT Committee meeting and in the informal meetings it held with individual 

or groups of WTO Members. The details and status of many of the specific trade concerns that 

the United States raised in, and on the margins of, the TBT Committee sessions are described in 

Section X of this report. As elaborated in Section X, U.S. interventions in the TBT Committee, 

and on its margins, have helped resolve a number of standards-related concerns affecting U.S. 

trade. The Committee’s annual review of its activities is contained in G/TBT/29, which 
35

includes a thumbnail description of the specific trade concerns that WTO Members raised, as 

well as identifies the Members that raised them. 

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 

has 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 will conclude in November 2012, the Committee will take stock of progress on 

the work called for under the fifth review, and seek to build upon and deepen engagement on 

that work through Member submissions and by discussing Member experiences. The key 

recommendations from the fifth review covered conformity assessment, good regulatory 

practice, internal coordination, transparency, and international standards. Those

recommendations are set out in G/TBT/26, and the collected decisions of the Committee are 

contained in G/TBT/1/Rev.10. 

Regulatory cooperation featured prominently in discussions under the Fifth Triennial Review. 

In 2011, the Committee held a workshop to advance understanding of how cooperation on 

regulatory issues can be used as an avenue for reducing unnecessary technical divergences as 

well as for achieving better regulatory outcomes – both of which can help to facilitate and 

expand trade. For example, regulatory efforts that effectively reduce the incidence of unsafe 

products benefit both the consumers who purchase those products as well as the producers that 

produce those products. In the Sixth Triennial Review, the Committee will discuss the outcomes 

of the workshop and seek to identify avenues to promote greater regulatory alignment. 

The Committee will also seek to advance implementation of good regulatory practice (GRP) 

over the course of the sixth review. One result of the fifth review was the development of a 

reference tool for Members seeking further information on available studies, guidelines, and 

case studies on implementing GRP. The Committee’s “Compilation of Sources on Good 

Regulatory Practice” (G/TBT/W/341) was published in September 2011, and is expected to be 

regularly updated in the future. Implementation of GRP is critically important because it carries 

the potential to help WTO Members in the following ways: enhance their capacity for market

surveillance; apply risk analysis in developing regulation; produce clarity in the definition of 

regulatory objectives; facilitate communication with industry, consumers and other 

stakeholders; provide a basis for effective training; maximize the benefits of trade facilitation; 

and generally ensure policy integrity. 

The benefits and challenges of greater use of international standards are also likely to feature in 

the Committee’s discussions under the Sixth Triennial Review. Worldwide use of international 

standards facilitates trade by helping firms achieve economies of scale in production, source 
36

low-cost global inputs, and achieve greater acceptance for their products across countries. In

recent years, the Committee has discussed ways to overcome challenges and institute best 

practices relating to the development and use of international standards to help firms in 

developing countries participate more fully in global markets. Developing country Members

often stress the challenges confronting their producers in complying with multiple or conflicting 

standards around the world. Many U.S. exporters strongly support the principle that 

governments should avoid mandating unnecessary local specifications for globally traded 

products. 

In earlier triennial reviews, WTO Members have shared experiences and reaffirmed the 

importance of both the TBT Agreement’s Code of Good Practice for developing, adopting, and 

using standards and the 2000 Committee Decision on the development of international 

standards. (In fact, the 2000 Committee Decision is an outcome of the Second Triennial 

Review.) The Code calls on Members to ensure that their standardizing bodies at the central 

level of government do not adopt standards that create unnecessary obstacles to trade, and to 

take reasonable measures to ensure that standardizing bodies at sub-central levels of government 

as well as private standardizing bodies do not produce standards that create unnecessary 

obstacles to trade. The 2000 Committee Decision states that processes for developing 

international standards should be transparent, consensus-based, and open to all interested 

parties. Both the Code and the 2000 Committee Decision seek to avoid duplication in standards 

development. 

In previous triennial reviews, the Committee’s work has also focused on conformity assessment. 

In the course of those reviews, the Committee held several events addressing conformity 

assessment32

G/TBT/1/Rev.10

and developed an indicative list of approaches that Members can use to facilitate 

the acceptance of results of conformity assessment procedures performed in other countries (see 

). In the Fifth Triennial Review, Members agreed to continue to exchange 

information on this subject, but broadened the scope of that exchange to include the criteria, 

methods of analysis, and concepts that Members use to inform their evaluation and choose 

conformity assessment procedures for specific purposes, including in the context of a risk 

management framework. Further, based on these exchanges, the TBT Committee agreed to 

initiate work on developing practical guidelines on how to choose and design efficient and 

effective mechanisms aimed at strengthening the implementation of the conformity assessment 

provisions of the TBT Agreement. The Committee will aim to advance this work in the Sixth 

Triennial Review.

Ways to improve how WTO Members implement the transparency requirements set out in the 

TBT Agreement always feature prominently in discussions under the triennial reviews. In 

particular, Members have focused on how to strengthen the manner in which Members are 

carrying out provisions of the TBT Agreement that require Members to give notice and 

comment on proposed technical regulations and conformity assessment procedures. The TBT

 32 These events were: (i) a Symposium on Conformity Assessment Procedures was held on 8-9 June 1999 

(G/TBT/9, 13 November 2000, Annex 1); (ii) a Special Meeting dedicated to Conformity Assessment Procedures 

was held on 29 June 2004 (G/TBT/M/33/Add.1, 21 October 2004); (iii) a Workshop on Supplier's Declaration of 

Conformity (SDoC) was held on 21 March 2005 (Annex 1 of G/TBT/M/35, 24 May 2005); and, (iv) a Workshop 

on the Different Approaches to Conformity Assessment, including on the Acceptance of Conformity Assessment 

Results, was held on 16-17 March 2006 (G/TBT/M/38/Add.1, 6 June 2006).
37

Agreement’s notice and comment rules, and the requirement for Members to take comments 

into account in finalizing the measures they notify, are fundamental to preventing and 

minimizing unnecessary obstacle to trade. The Committee has produced a significant body of 

recommendations and decisions on these transparency procedures. 

Asia Pacific Economic Cooperation

2011: The U.S. APEC Year

APEC33 is the Asia-Pacific region’s premier inter-governmental economic organization. Its core 

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

investment. APEC’s 21 member economies comprise nearly half the world’s population and 

more than half of the global economy. These member economies account for 55 percent of 

global GDP, purchase 58 percent of U.S. goods exports, and comprise a market of 2.7 billion 

customers. In fact, seven of America’s top 15 trade partners are in APEC. As host of APEC in 

2011, the United States used this historic opportunity to advance a trade and investment agenda

to assist in sustaining economic recovery by supporting growth in trade, investment and jobs in 

the region. The United States chaired a series of ministerial and other meetings throughout the 

year, including the Trade Ministers meeting in Big Sky, Montana on May 19-20, 2011, and the 

APEC Leaders’ Meeting hosted by President Obama in Honolulu on November 12-13, 2011.

In its role as APEC chair, the United States emphasized the importance of building towards a 

seamless regional economy by achieving practical, concrete, and ambitious outcomes in three 

priority areas:

• strengthening regional economic integration and expanding trade;

• promoting green growth; and

• expanding regulatory cooperation and advancing regulatory convergence. 

Specifically, the United States achieved a series of practical, concrete, and ambitious outcomes 

that will advance regulatory convergence and cooperation in the region, including by improving 

the regulatory environment in the region. First, the United States succeeded in persuading the 

APEC economies to agree to take specific steps to strengthen their implementation of good 

regulatory practices (GRPs). This initiative complements the work that APEC has conducted 

since its inception in 1989 to promote those practices, encourage greater alignment of 

international standards, reform testing and certification programs, and advance development of a 

standards and conformity assessment infrastructure in the region. 

 33 The APEC members are Australia, Brunei Darussalam, Canada, Chile, China, Hong Kong China, Indonesia, 

Japan, Korea, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, the Philippines, Russia, Singapore, 

Taiwan, Thailand, Vietnam, and the United States.
38

The United States also gained agreement on specific recommendations to prevent and eliminate 

unnecessary technical barriers related to emerging green technologies, including commercial 

green buildings, solar technologies, and smart grid. Additionally, the United States worked to 

encourage APEC economies to adopt standards and conformity assessment procedures that 

promote greener growth by encouraging alignment of energy efficiency standards and 

conformity assessment procedures to information and communication technology (ICT)

equipment and applying ISO 50001, an international energy management systems standard that 

will establish a framework for industrial plants, commercial facilities, or entire organizations to 

manage their energy use. Finally, the United States led efforts to establish a Global Food Safety 

Partnership Program at the World Bank, with USAID and private sector support, to strengthen 

food safety and facilitate trade through public - private collaboration based on the partnership 

training model pioneered in APEC.

These initiatives are described in more detail below. In 2012, the United States will seek to 

advance the work that the United States and its APEC partners initiated or strengthened during

the U.S. APEC year. 

Good Regulatory Practices

In close cooperation with New Zealand, Australia, and Mexico, the United States spearheaded a 

proposal that was adopted by all of APEC economies to take specific steps to implement GRPs

by the end of 2013, including by ensuring internal coordination of rulemaking, assessing the 

economic impact of regulations, and conducting public consultations, in order to reduce 

unnecessary burdens on businesses that cost time and money. This achievement came as a 

result of a year-long series of activities to support implementation of GRPs,

34 beginning with the 

APEC’s 6th Conference on Good Regulatory Practice in March 2011, which brought together 

experts from governments, business, and international organizations to discuss the critical 

regulatory issues facing the APEC community. 

The initiative also resulted in the completion of two important studies: (1) a study of the ways 

in which GRPs support the goals and obligations of the TBT Agreement, entitled “Supporting 

the TBT Agreement with Good Regulatory Practices: Implementation Options for APEC 

Members,”35; and (2) a report on the specific ways in which APEC member economies have 

implemented GRPs to date, entitled “Good Regulatory Practices in APEC Member Economies: 

A Baseline Study.”36 The former study provides an in-depth examination of the relationship 

between implementing GRPs and the requirement under the TBT Agreement to prevent 

unnecessary obstacles to trade. The latter study reviews the application of selected GRPs from 

the APEC-OECD Integrated Checklist for Regulatory Reform37

 34 Final Report of the Subcommittee on Standards and Conformance’s 6th Conference on Good Regulatory Practice 

can be found in the APEC Meetings Document Database, Document Number 2011/SOM1/SCSC/032rev1.

across the 21 APEC members, 

35 “Supporting the TBT Agreement with Good Regulatory Practices: Implementation Options for APEC Members”

can be found at http://publications.apec.org/publication-detail.php?pub_id=1266.

36 “Good Regulatory Practices in APEC Member Economies: A Baseline Study” can be found in the APEC 

Meetings Document Database, Document Number 2011/CSOM/032.

37 The APEC-OECD Integrated Checklist on Regulatory Reform can be found at 

http://www.oecd.org/dataoecd/41/9/34989455.pdf .
39

with a focus on several procedures that promote regulatory quality standards important to trade 

and investment, such as accountability, consultation, efficiency, and transparency. 

Smart Grid

The APEC Committee on Trade and Investment (CTI) launched an “APEC Regulatory 

Cooperation Advancement Mechanism” (ARCAM) in 2011 on the topic of smart grid 

interoperability standards. Following an intensive dialogue on the topic, APEC economies 

agreed in November on a set of actions and principles designed to prevent unnecessary obstacles 

to trade and investment arising from smart grid interoperability standards, which can hinder the 

achievement of broader economic and societal benefits resulting from the deployment of smart 

grid technologies across the region. Among the set of actions and principles that the APEC 

economies agreed to include increasing collaboration on technical solutions related to smart grid 

interoperability standards; fostering coherence in architectural approaches to interoperability; 

and promoting standards and conformance solutions that facilitate trade and investment across 

the APEC region and globally. The APEC economies also agreed to take steps to promote 

transparency, collaboration, and global solutions in the development of smart grid 

interoperability standards; to take actions to enable competition and innovation in specific 

markets for smart grid technologies; and to integrate ARCAM principles into collaborative work 

in other international and regional fora.

The United States will seek to prompt further progress in this area by conducting a second 

workshop for smart grid regulators, entitled, “Regulatory Approaches to Smart Grid Investment 

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

2012, in Quebec City, Canada.

Green Buildings

For the first time, the SCSC, led by the United States, addressed trade related standards and 

conformity assessment measures for new commercial green buildings with an ambitious project 

that drew support from a broad constituency of green building stakeholders from the private 

sector.

Products used in green buildings offer significant export potential for U.S. manufacturers as well 

as energy savings for the urbanizing Asia Pacific region. Green buildings constitute an exciting

new technology sector and APEC can help make APEC member green building standards 

consistent, transparent, and appropriate and thus avoid creating unnecessary obstacles to trade in 

the sector. The SCSC’s work, which reflected the green growth priority that was a key element 

of the U.S. APEC year, included a survey of APEC members, workshops, and case studies on 

green building issues. 

The SCSC’s survey examined green building standards and codes in the region and established

baseline data for the remainder of the project. The Subcommittee convened two workshops on 

green building standards and rating systems, which provided a forum for APEC member experts 

to develop goals for facilitating trade in green building products. The SCSC conducted two case 

studies on green building rating systems and practices related to life cycle assessment for 

 
40

building products. The studies provide APEC members detailed information on the 

opportunities and challenges in APEC markets to obtain the necessary certifications and 

requirements for acceptance and access. 

In November 2011 APEC Leaders noted the importance of pursuing common objectives to 

prevent technical barriers to trade related to emerging green technologies, including green 

buildings. The United States expects to advance work in APEC in 2012 to promote the free 

flow of trade in green building products. 

Solar Technologies

The United States led a new initiative in the SCSC on Solar Technologies Standards and 

Conformance, along with Chinese Taipei, Japan, Indonesia, and Peru. The purpose of the 

initiative was to determine the state-of-play for standards and conformity assessment for solar 

technologies in the Asia Pacific region, to increase transparency in developing and applying

those measures and to encourage APEC economies to align those measures to international 

standards and conformity assessment schemes for photovoltaics, solar water heating, and 

concentrated solar power. 

As a result of the SCSC’s year-long work on these solar technologies, APEC members identified

concrete areas for collaboration on standards and conformity assessment that will facilitate trade 

and investment in solar technologies. These outcomes consisted of practical ways to reduce 

costs, increase safety, and improve reliability of these three major solar technologies with the 

goal of increasing the performance of solar technologies and speeding their adoption thereby 

advancing significant environmental and societal benefits in and beyond the APEC region. The 

November 2011 APEC Leaders Statement endorsed the importance of these outcomes, and 

stressed the need for further work to prevent technical barriers to trade related solar 

technologies. The United States expects to advance work in APEC in 2012 toward developing a 

multi-year project to ensure the free flow of solar technology products. 

Information and Communication Technologies

In line with the 2010 APEC Leaders’ statement on the importance of work on standards and 

conformance to reduce the impact of non-tariff barriers on free and open trade and investment, 

the United States led an initiative in 2011 to explore opportunities for converging energy 

efficiency regulations for information and communication technology (ICT) products across 

APEC economies. By converging energy efficiency regulations, APEC economies can was

avoid adopting disparate regulatory requirements and minimize trade barriers for ICT products, 

thereby promoting trade in those products and reaping energy efficiency gains in other sectors 

that can benefit by deploying these technologies. The U.S. initiative led to a clearer

understanding of new energy efficiency requirements for ICT products across the region, and 

examined ways in which the public and private sectors can better collaborate on energy 

efficiency targets in order to facilitate trade for ICT products and services.38

 38 Outcomes of the Conference on Aligning Energy Efficiency Regulations for ICT Products can be found in the 

APEC Meeting Documents Database, Document Number 2011/SOM3/SCSC/039.

 The energy 

efficiency experts who participated in the initiative reached agreement on principles to consider 
41

when developing energy efficiency regulations, which were subsequently endorsed by the 

APEC economies. 

To continue to make progress in 2011 on converging ICT energy efficiency regulations, the 

United States has proposed that APEC economies should consider ways to refine and implement 

the agreed principles.

Food Safety

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

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

food safety incidents, prompting APEC Leaders to issue a collective mandate to improve food 

safety standards and practices in the region without creating unnecessary barriers to trade. In 

response, the SCSC established the Food Safety Cooperation Forum (FSCF) in 2007 with the 

goal of improving food safety regulatory systems in APEC economies, including food 

inspection, assurance, and certification systems that are consistent with WTO Members’ rights 

and obligations under both the SPS and TBT Agreements.39

Partnership Training Institute Network (PTIN). 

 Additionally, in 2008, APEC 

Leaders called for increased capacity building to improve technical competence and 

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

the U.S.-led initiative, the 

Work by the United States to build food safety capacity in the Asia Pacific region through these 

mechanisms led to several groundbreaking events in 2011. For example, at Big Sky, the APEC 

countries agreed to initiatives to reduce unnecessary requirements in official export certificates; 

to promote greater harmonization to international standards and to improve laboratory 

proficiency and competency in order to improve food safety and to facilitate trade. In addition,

APEC and the World Bank signed a landmark Memorandum of Understanding (MOU) marking 

an ongoing commitment to boost food safety in the region. The MOU laid the groundwork for 

the creation of a Global Food Safety Partnership, announced in November. 

The MOU and the Global Food Safety Partnership are based on the model of public-private 

collaboration on food safety pioneered through the PTIN. In 2011, the PTIN continued its food 

safety capacity building efforts by hosting workshops on food incident management and 

laboratory competency as well as developing a strategy for improving laboratory proficiency in 

the region. The PTIN also hosted a public-private sector roundtable in May 2011 that brought 

together more than 100 government, industry, and academic stakeholders to identify the most 

urgent food safety capacity building needs for 2011-2013. 

The United States will continue to work to improve the capacity of APEC and other economies 

to regulate food safety consistent with international standards and further the adoption of 

science- and risk-based approaches that will improve public health while also facilitating trade 

in the processed food sector. In 2012, the FSCF PTIN will work with the Global Food Safety 

Partnership Program to begin initiating pilot programs and plan workshops on export certificates 

and laboratory capacity building, as well as launch the first use of reproducible training modules 

with a pilot trainer workshop in China focused on supply chain management.

 39 The FSCF covers both SPS and TBT issues and descriptions of the activities of the FSCF are included in both the 

2012 TBT Report and the 2012 SPS Report. 
42

Wine Regulatory Forum

In 2008, the SCSC created a Wine Regulatory Forum (WRF) to promote ways to regulate wine 

in a manner that facilitates trade. Wine exports are critically important to several APEC

economies, with these economies exporting $3.6 billion in wine products in 2010. In 2011, the 

WRF held a workshop marking the first-ever meeting of wine regulators and industry 

representatives from both wine producing and consuming economies in the APEC region.

40 The 

goal of the workshop was to prevent unnecessary impediments to wine trade, including by 

streamlining wine import and export regulations. Participating regulators also shared best 

practices on wine certification, analysis, winemaking practices, and wine labeling. 

The WRF seminar produced a “Compendium of Wine Import Certificate Requirements of 

APEC Economies.” The compendium outlines the five types of certification requirements in 

use in APEC economies and illustrates how difficult it is for exporters to understand the 

differences between the various requirements. These diverse requirements currently impose

unnecessary costs and other obstacles to intra-APEC wine trade. The seminar encouraged 

APEC economies to streamline documentation requirements to minimize unnecessary 

restrictions to trade.

Trans-Pacific Partnership

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

negotiations to conclude an ambitious, next-generation trade agreement in the Asia-Pacific 

region that reflects U.S. priorities and values. The Trans-Pacific Partnership (TPP) agreement is 

a key initiative through which the United States seeks to advance the multi-faceted U.S. trade

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

regional trade agreement along with Australia, Brunei Darussalam, Chile, Malaysia, New 

Zealand, Peru, Singapore, and Vietnam. The TPP has begun with this initial group of likeminded countries with the goal of creating a platform for regional integration across the region. 

In 2011, the TPP countries made substantial progress in negotiations on issues relating to 

standards-related measures.

In the TPP negotiations addressing standards-related issues, the United States is emphasizing

several key themes, including regulatory transparency, encouraging the use of GRPs, and 

facilitating 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 unnecessary 

technical barriers to trade. 

In the modern global economy, open and transparent procedures for developing technical 

regulations, standards, and conformity assessment procedures are essential to avoiding 

unnecessary technical barriers to trade. In particular, where regulators provide early notice to 

interested parties at home and abroad that they are considering adopting new measures, the 

interested parties can help regulators obtain the information they need to design the measures in 

 40 APEC Wine Regulatory Forum Report can be found in the APEC Meeting Documents Database, Document 

Number 2011/SOM3/SCSC/055.
43

a way that avoids placing unnecessary burdens on local and foreign producers. Moreover, when 

regulators use transparent procedures in developing regulations, they also help ensure that both 

domestic and foreign stakeholders will view the final regulations as legitimate. In addition, 

transparent implementation of measures and reasonable compliance periods will enhance legal 

certainty and predictability for suppliers and make it easier for them to comply. 

Transparent procedures in developing regulations are also vital in crafting high quality, sciencebased regulations. In particular, these procedures help governments avoid adopting unneeded, 

inappropriate, or overly burdensome technical regulations, while enhancing the competitiveness. 

The United States is also working to reach agreement in the TPP negotiations on the principle 

that suppliers do not need to have their facilities inspected more than once or have their products 

tested more than once in order to demonstrate that they comply with technical regulations and 

standards in place in a particular export market. In addition, the United States is seeking 

commitment from each TPP government that it will permit suppliers in other TPP countries to 

allow testing to be carried out by a conformity assessment body of their choice, regardless of 

where it is located, as long as the body meets the importing country’s criteria for approved 

assessment bodies. 

CAFTA-DR

In 2010, the United States hosted the first meeting of the TBT committee, which was established 

in the Central America and Dominican Republic Free Trade Agreement (CAFTA-DR), 

originally signed by Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, the Dominican 

Republic, and the United States in 2005. Following the 2010 meeting, the United States 

launched an initiative to provide technical assistance to the CAFTA-DR countries to ensure 

compliance with the CAFTA-DR TBT chapter. 

The 2011 TBT Committee meeting was coupled with a workshop co-hosted by the United States

and Costa Rica to further these capacity building objectives. The workshop consisted of four 

sessions that covered the following topics: (1) best practices in the development and 

implementation of technical regulations, standards, and conformity assessment procedures; (2) 

an overview of good practices in achieving the objective of safe consumer products; (3) a 

discussion of building resilient and reliable telecommunications structures through regulatory 

approaches that enable a dynamic telecommunications market; and (4) TBT issues in food trade. 

The CAFTA-DR countries all reported a positive experience with the workshop and are 

planning to hold more workshops to continue the spread of best practices in carrying out the 

obligations of the CAFTA-DR TBT chapter. 

Regulatory Cooperation Fora

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

regulatory best practices and aligning regulatory approaches in economically significant sectors. 

In addition, the United States attempted to advance these goals through the Doha Round 

negotiations at the WTO. 
44

European Union

The EU’s approach to standards related measures (as described in the 2011 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 2011, U.S. officials 

continued 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 High-Level 

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, oversees a program of bilateral cooperation on 

regulatory issues. The group has convened in advance of each of the previous three TEC 

meetings to identify projects for the TEC to consider. 

In 2011, the United States and the EU accomplished several cross-cutting TEC-directed 

initiatives through the HLRCF, including the development of a shared set of principles and best 

practices for regulation (“Common Understanding on Regulatory Principles and Best 

Practices”), and an agreement on “Building Bridges between the U.S. and the EU Standards 

Systems.” During the November 2011 TEC meeting, the United States and EU agreed to 

implement this agreement and to engage in sustained dialogue through the HLRCF to exchange 

views and information on regulatory developments and to identify promising projects for 

regulatory and standards issues. 

At the November TEC meeting, the United States and the EU also agreed to foster meaningful 

cross-cutting exchanges among economic policy makers, regulators, and standard-setting 

bodies, and to avoid creating new and unintended barriers to bilateral trade and investment, 

especially in key emerging technologies and innovative sectors, such as nanotechnology. The 

United States and the EU agreed that their relevant agencies would enter into a regular dialogue

to exchange information, views on developments relevant for regulatory compliance, and to 

report on regulatory developments. 

Mexico

In May 2010, President Obama and Mexican President Calderón committed to enhance 

significantly the economic competitiveness and the economic well-being of the United States and 

Mexico through improved regulatory cooperation. The Presidents directed the creation of a 

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

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

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

on nanotechnology, motor vehicle safety, e-health and other topics.41

 41 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. 
45

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.

On December 7, 2011, the United States and Canada released an RCC joint action plan covering 

initiatives pertaining to transportation, agriculture and food, personal care products, 

pharmaceuticals, environment, nanotechnology, and occupational safety.42 Regulatory officials 

from the United States and Canada met in January 2012 to cover issues included in the joint action 

plan, and plan to continue working through the RCC to provide early notice of regulations with 

potential cross-border effects, strengthen the analytical basis of their regulations, and help make 

their regulations more compatible. 

Doha Round Negotiations

The United States has sponsored three non-tariff barrier (NTB) proposals in the WTO’s Doha 

Development Agenda negotiations on of the Non-Agricultural Market Access (NAMA) aimed at 

reducing standards-related barriers to trade. These proposals cover: (1) textiles, apparel, 

footwear, and travel goods (TAFT);43 (2) electronic goods;44 and (3) automotive goods.45 WTO 

Members have set all three of these proposals for priority negotiations as part of the overall 

NAMA NTB negotiations and the proposals were included in the NAMA Chair’s December 

2008 negotiating text46 as well as the Chair’s April 2011 report on the state of play in the 

negotiations.47 The 2010 and 2011 TBT Reports address these proposals in detail. 

During 2011, the NAMA Chair led small group negotiations on the U.S. textile proposal and on 

a transparency proposal largely based on provisions in the U.S. electronics and automotive 

goods texts. These meetings generated working documents that reflect a broad consensus 

among small group participants and satisfy many priority U.S. NTB negotiating goals. But gaps 

 42 More information on the U.S.-Canada Regulatory Cooperation Council, including the Joint Action Plan, can be 

found at http://www.trade.gov/rcc/. 

43 Understanding on the Interpretation of the Agreement on Technical Barriers to Trade with respect to the Labeling 

of Textiles, Clothing, Footwear, and Travel Goods (TN/MA/W/93/Rev.2, 8 November 2010).

44 Understanding on Non-Tariff Barriers Pertaining to the Electrical Safety and Electromagnetic Compatibility 

(EMC) of Electronic Goods (TN/MA/W/105/Rev.3, 26 November 2010).

45 Understanding on Non-Tariff Barriers Pertaining to Standards, Technical Regulations, and Conformity 

Assessment Procedures for Automotive Products (TN/MA/W/120, 9 July 2010).

46 Fourth Revision of the Draft Modalities for Non-Agricultural Market Access (TN/MA/W/103/Rev.3, 6 December

2008. The list of proposals is in paragraph 24.).

47 Textual report by the Chairman, Ambassador Luzius Wasescha, on the state of play of the NAMA negotiations

(TN/MA/W/103/Rev.3/Add.1, 21 April 2011).
46

still remain in key areas and the wider WTO membership has not fully vetted the working 

documents. Thus, while the small group negotiations have been productive, further work is 

required to reach agreement among all WTO Members. While the outlook for the NTB 

negotiations in 2012 is uncertain due to the broader impasse in the Doha Development Agenda, 

the United States will remain attentive to possibilities in the WTO and in other negotiating 

forums to pursue its objectives on textiles labeling and transparency, as well as for other priority 

NTB areas, such as electronics and autos. 
47

X. Trends in 2011

The U.S. government actively seeks to prevent and eliminate unnecessary technical barriers to trade 

by participating in a variety of forums and engaging through many different levels of the 

government. The preceding sections of this report reviewed U.S. government engagement in 

bilateral and multilateral venues on specific trade concerns and on systemic issues. Section 

XI provides a summary of many of the specific concerns of the United States with 

standards-related activities in specific countries. This section reviews trends that appear 

across various U.S. trading partners’ markets, as well as standards-related systemic issues, that 

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

Regulatory Measures on Goods with Cryptographic Capabilities

A number of U.S. trading partners, including China, India, and Russia, have adopted or are 

considering adopting measures that block or restrict U.S. exports of products with cryptographic 

capabilities for commercial use. As an increasing number of products for commercial use are being 

designed with cryptographic capabilities to protect data integrity and confidentiality, these measures 

have the potential to significantly impede trade in a wide range of industrial products and systems. 

As one example, China is considering implementing rules for its Multi-Level Protection Scheme that 

could limit access to China’s market solely to those firms that are willing to disclose their

proprietary encryption technology to the government. Likewise, China, India, and other countries 

require – or are considering requiring – U.S. companies to enter into joint ventures with indigenous 

partners, thus jeopardizing business proprietary information, or requiring U.S. companies to use a 

country-specific cipher or algorithm. These measures tend to favor or require the use of specific 

domestic technologies that might not offer the strongest protection available, and they may lead to 

the forced transfer of intellectual property. Consequently, these measures could stifle innovation and 

have a chilling effect on trade. 

The United States is working with its trading partners to resolve these specific market access 

concerns and to ensure that other trading partners do not adopt similar troublesome practices in the 

future. The United States will promote non-discrimination, the use of relevant international 

standards as a basis for regulation, and transparency and predictability in the development and 

implementation of measures regarding goods with cryptographic capabilities. Further, the United 

States is evaluating other opportunities to collaborate with its trading partners to help prevent the 

spread of problematic practices in the encryption sphere, including through the TPP negotiations. 

Mandatory Labeling of Genetically Engineered Foods

During 2011, the United States continued to have trade concerns regarding mandatory, processbased labeling of foods produced from genetically-engineered (GE) products, such as varieties of 

GE corn or GE soybeans (GE foods). The 2011 TBT Report detailed the trade concerns arising 

from mandatory labeling practices for GE foods. (For a full description of these concerns, and 

concerns raised by similar barriers, see pages 49-50 of the 2011 TBT Report.)

In May 2011, following 20 years of discussions and negotiations, the 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 
48

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 FDA applies a science-based 

approach to food safety, 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. 

During 2011, Colombia, Peru, and Ukraine notified the WTO of proposed new labeling 

requirements for GE foods. These measures vary considerably in their consistency with Codex 

guidance. Colombia’s proposal stipulates that mandatory GE labeling will not be required for 

prepackaged GE food if it is substantially equivalent to a non-GE counterpart that is already on 

the market. In line with Codex guidance, Colombia’s proposal will require labeling only in 

limited cases, such as when: (1) nutritional components are not substantially equivalent to those 

in the non-GE counterpart; (2) handling requirements differ from those for the non-GE 

counterpart; (3) the GE-derived food contains unexpected allergens; or (4) certain other 

properties of the GE-food differ from those of the non-GE counterpart. By contrast, the 

Ukrainian and Peruvian measures raise trade concerns, as they appear to require all food 

products containing certain GE ingredients to be identified on the product label, with only limit 

exceptions. 

The United States is also concerned that a recent European Court of Justice (ECJ) ruling could 

extend the EU’s practice of mandatory labeling for GE foods to honey. The ECJ recently ruled 

that honey containing pollen with 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. At the November 2011 TBT Committee meeting, several WTO Members objected to 

the European requirements. They observed that the relevant Codex standard does not treat 

pollen as an ingredient and they urged the EU to withdraw its requirement for honey producers 

to include a reference to pollen from GE plants on their labels.

The United States will continue to raise trade-related concerns with mandatory biotechnology 

labeling requirements in 2012 that are based on the manner in which food is produced rather 

than on scientific principles.

Alcoholic Beverage Regulations

Regulations and requirements that foreign governments impose on alcoholic beverages are the 

subject of about one-third of all the concerns the United States has raised in multilateral and 

bilateral fora regarding technical barriers to trade in food and beverages. U.S. exports in the 

sector have increased by 32 percent over the last five years, to $2.5 billion in 2011. At the same 

time, governments continue to impose unnecessary barriers to U.S. exports in this sector, 

including by adopting labeling requirements, definitions specific to products of a specific 

region, and unique standards for specific spirits, and certification practices that restrain trade.

The United States supports the goal of reducing alcohol abuse, including through the use of 

appropriate alcoholic beverage warning labels, as well as other labeling requirements designed 

to communicate appropriate information to consumers. A number of governments have adopted 

labeling measures, however, that may impose unnecessary costs or raise other barriers to trade 

in these products. For example, Russia, Thailand, and Kenya promulgated measures requiring 

over-size warning labels for all alcoholic beverages (which in some cases may cover up to 30
49

percent of the bottle) that have the potential to cover trademarks and other brand information. In 

addition, Israel and Russia recently adopted EU region-specific definitions for distilled spirits, 

creating trade barriers for certain U.S. whiskeys. The adoption of country or region-specific 

standards for distilled spirits, as several countries, such as Brazil and Colombia are considering, 

may also be problematic for U.S. exporters. 

The United States achieved some progress in addressing barriers to its wine exports in 2011, 

including with respect to efforts to reduce burdensome or unnecessary testing requirements. In 

APEC, for example, wine regulators met for the first time and compared certification 

requirements across the Asia Pacific. Understanding the complexity and diversity of these 

testing requirements is a necessary first step to promote greater alignment. In addition, in 2011

the United States reached agreement with Vietnam on its processing requirements for alcoholic 

beverages, including chemical and microbiological parameters, heavy metals, and food additive 

and labeling requirements. Most significantly, Vietnam acknowledged that there is no widely

accepted scientific or technical basis for imposing limits on aldehyde content and repealed a law 

that imposed a maximum limit on this naturally occurring substance that is present in many 

distilled spirits. 

More details on this subject can be found in the country reports on Brazil, Colombia, the EU, 

Kenya, Russia, Thailand, and Vietnam in Section XI.

Organic Product Standards

Divergences in regulatory approaches to organic products can make exporting U.S. organic 

products a costly and burdensome endeavor and, in some instances, prohibitively so. In the 

organics sector, the United States has negotiated three types of agreements with major trading 

partners in an attempt to facilitate trade in organic products:

• Under a “recognition agreement,” an importing country agrees to recognize USDA’s 

National Organic Program (NOP) to accredit agents within the United States to certify 

products as organic under the importing country’s requirements.

• Under an “equivalency arrangement,” the United States and another country agree to 

allow some or all products produced and certified to the exporting country’s organic 

requirements to be sold as organic in the importing country.

• Under an “export arrangement,” U.S. organics producers can sell their products as 

organic in another market, provided that their products meet specific requirements of the 

importing country.

(For some example of the agreements signed by the United States in the organics sector, see 

page 52 of the 2011 TBT Report.) U.S. efforts to enter into agreements and arrangements of this 

nature have been highly effective in facilitating trade in organic products. For example, the 

United States and Canada have had an organics equivalency agreement in place since 2009. 

Just recently, in February 2012, the United States and the EU reached agreement on an historic 

organics equivalency arrangement that will allow organic products certified in Europe or in the 

United States may be sold as organic in either region. 
50

The partnership between the world’s two largest organics producers will establish a strong 

foundation from which to promote organic agriculture, benefiting the growing organic industry 

and supporting jobs and businesses in both the United States and Europe.

In some instances, the United States has not been able to bridge some, or all, of the differences 

between U.S. and foreign organics requirements using recognition agreements and equivalence

arrangements, and U.S. organics exporters still face challenges. For example, Japan’s 

restrictions on alkali extracted humic acid, a substance that USDA permits for use on U.S. 

organic crops, limits U.S. organics exports. Similarly, Korea’s zero tolerance policy for 

adventitious presence of biotechnology content in organic products limits U.S. organics exports.

If Korea does not adopt legislation allowing it to negotiate one or more of the equivalence

arrangements outlined above, U.S. organics exports to Korea could be further restricted 

beginning in January 2013. Further, China currently does not allow organic products produced 

under foreign standards in their market. All products must be certified according to Chinese 

organic standards.

U.S. officials continue to engage regularly with trading partners, including Japan, Korea and 

China in an attempt to resolve these issues and to prevent new issues from arising.

Formula Disclosure Requirements

The 2011 TBT Report highlighted concerns regarding a growing number of countries that 

require food producers to disclose proprietary product information as condition for exporting 

their products to those countries. These measures typically call for proprietary information to be

either (1) included on a product’s label; (2) disclosed at the time a product is registered for sale 

in the market. 

Food additives may contain a single ingredient, but they may also include proprietary mixtures 

of multiple ingredients. Governments typically consider product ingredients, such as the 

flavored marinades producers inject into meat products, to be additives because they perform a 

technological function. If governments require producers to declare each ingredient in their 

marinades or other additives by weight or percentage, it would enable competitors to reproduce 

each other’s proprietary flavors and other food additives.

As previously reported, Brazil, Indonesia, and Japan require food labels not only to list a 

product’s ingredients but also the percentages of each ingredient. In 2011, China and Thailand 

considered measures that would mandate similar disclosure requirements for food additives. 

These requirements are inconsistent with Codex labeling standards, which recommend that all

ingredients be listed in descending order of ingoing weight at the time of the manufacture of the 

food. Codex labeling standards also explicitly lay out separate circumstances in which 

percentages of ingredients must be declared, but under circumstances where a certain ingredient 

is emphasized on a product label or is essential to the food, to avoid misleading consumers. 

Additionally, some countries, such as China, and Venezuela, have adopted measures that require 

companies to disclose a product’s precise recipe or formula as part of their product registration 

process. Forcing food companies to declare proprietary recipes or formulas can damage 

legitimate commercial interests. While Codex guidelines allow governments to require 

producers to disclose essential information relating to quality and safety, there is little reason to 
51

believe that requirements for producers to disclose the precise weight or percentage of each 

ingredient they use to make their products will assist governments or consumers determine 

whether those products are safe or meet domestic food quality standards. 

During 2012 the United States will continue to work bilaterally and through international fora to 

eliminate unwarranted disclosure requirements of this kind. 

Documentation Requirements

Across industry sectors, U.S. exporters have faced onerous documentation requirements as a 

condition for marketing their products abroad. These requirements may raise costs for U.S. 

exporters or serve as a barrier to entry when they are duplicative or simply unnecessary. For 

example:

• Brazil, China, Russia, and Switzerland, among other countries, require certificates of 

analysis from U.S. wine exporters as well as certificates verifying that their wines 

conform to both U.S. and the importing country’s standards. Some of these countries 

also require these certificates to take the form of an original document issued by U.S. 

government officials or officially accredited organizations from the country of 

importation, a requirement that can impose considerable burdens and costs. For

example, Russia requires U.S. wineries to pay $5,000 for the two hygiene certificates it 

requires and to obtain a Gosstandart Russia Certificate of Conformity to wine standards.

• Chile, Costa Rica, the Dominican Republic, Guatemala, Indonesia, Peru, and Vietnam, 

among other countries, require U.S. exporters of certain products to transmit documents 

to the local embassy of the country of importation for an official approval or stamp,

which often requires payment of a fee, before filing applications for approval. This can 

result in extensive delays and add significant costs for exports without providing any 

clear benefit. 

• China and Korea require medical device producers to submit evidence that the device 

offered for export has been approved in the country of manufacture or origin. Not only 

does this requirement add costs and delays to the approval process, it is often inapposite 

because the product has been designed exclusively for export. 

• Similarly, a wide range U.S. food producers has repeatedly noted that unwarranted 

foreign government import and export certification requirements (such as “certificates of 

free sale”) can impose substantial trade barriers. While it is difficult to estimate the costs

that certification requirements impose, they include lost market share, unnecessary

bureaucratic hurdles that cause lengthy delays, and costs producers incur when 

shipments are rejected because they do not meet certification requirements. 

• Brazil requires medical device producers to submit business proprietary economic data 

(e.g., prices in other markets, distributor mark-ups, advertising/promotion budgets) as a 

condition for registering or re-registering their products, even though such data may not 

exist or is unrelated to medical device safety or efficacy. In addition, Brazil’s medical 

device regulator has sometimes publicized these data. 
52

The United States works to resolve these issues as they arise in individual cases through the 

TBT Committee, APEC, U.S. FTAs, and bilateral engagement. The United States looks for 

opportunities to resolve these issues, or prevent their emergence, on a systemic basis. For 

example, the United States worked extensively during 2011 with its CAFTA-DR partners to 

address redundant and unnecessary documentation requirements that governments in the region 

have imposed for food products. During the CAFTA-DR TBT committee meeting in November 

2011, for instance, the United States presented information on the challenges facing exporters as 

a result of these requirements. Following the meeting, Costa Rica took action to recognize 

USDA meat export certificates as equivalent to Costa Rica’s import certificate requirements. 

The United States is also actively working through APEC to streamline export certificate 

requirements for agricultural products consistent with Codex guidelines. Based on work done in 

2010, the United States secured a commitment by the APEC Leaders in 2011 to reduce and 

streamline certification requirements where possible and to consider the use of electronic 

certification as a means to facilitate trade in safe food. The TPP negotiations may present 

another opportunity for the United States to make progress on this issue.

“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 mandatory. In addition, 

many truly voluntary standards that governments have developed (such as voluntary labeling 

programs related to energy efficiency or agricultural products) have created substantial trade 

barriers. While the TBT Agreement requires WTO Members to ensure that voluntary technical 

measures (“standards,” in TBT parlance) do not create unnecessary obstacles to trade, they are 

not subject to the same rigorous transparency disciplines under the TBT Agreement as 

mandatory standards (which the TBT Agreement refers to as “technical regulations”). 

Some of the mechanisms that countries are using to turn voluntary standards into official

requirements include procurement requirements (including state-owned enterprises), licensing 

requirements, and other government programs. Because the TBT Agreement does not require 

WTO Members to develop voluntary standards through procedures that include input from 

foreign stakeholders (although it does require Members regularly to publish the work programs 

of standards under development by central government bodies), voluntary standards may solely 

reflect domestic stakeholder interests rather than those of the larger global trading community

and may not take into account the operation of global supply chains. For example: 

• China is finalizing several draft “voluntary” standards related to information security that 

the United States is concerned China will make 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 

Certification and Accreditation Administration (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 question 

how it relates to protecting national security. U.S. industry and the U.S. Government

are concerned that China may in the future mandate the use of this standard by 
53

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 Energy Management Corporation (KEMCO) only certifies one type of thin 

film solar panel – the type that Korean producers manufacture – as meeting its version of 

the International Electrotechnical Commission standard. While compliance with that 

standard is not technically required for sale of solar panels in the Korean market, a 

company will not be commercially viable in Korea without KEMCO certification. As a 

result, U.S. solar panel producers that make different kinds of thin film panels find 

themselves locked out of the Korean market.

• The organic and halal standards that several governments have adopted are technically 

voluntary, but they often serve to preclude U.S. products from entering the market. For 

example, when Malaysia put in place a voluntary standard that did not allow for halal 

products to be manufactured on a dedicated line within a facility that also produces nonhalal products, many U.S. poultry and beef producers were effectively excluded from the 

Malaysian market. This is because Malaysia bans imports of non-halal poultry and beef 

products and it is often too costly for U.S. producers to set up separate production 

facilities for those products. 

As with the other issues identified in this section of the report, the United States works to 

resolve issues concerning voluntary standards through the TBT Committee and regional and 

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

address these issues on a systemic basis as 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. The 

United States will also look to discuss this issue through the TBT Committee during the Sixth 

Triennial Review of the TBT Agreement.
54

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.48

The decisions on which issues to include resulted from an interagency process that incorporated 

the expertise of a variety of government agencies.

While the tools used to address TBT barriers vary depending on the particular circumstances, in

all instances, USTR’s goal remains the same: to work as vigorously and expeditiously as

possible to resolve the issue in question. As reflected in the country reports, in many instances

USTR seeks to resolve specific concerns through dialogue with the pertinent trading partner –

either bilaterally or through multilateral fora – and working collaboratively to obtain changes 

that result in improved market access for U.S. exporters.

The TBT Report provides more focused and structured reporting on country-specific standards

related issues compared to what appeared in prior NTE reports. Conversely, some prior NTE

reports may have included standards-related issues that USTR has not included in the TBT

Report.

In response to USTR’s outreach in compiling this report, stakeholders raised a number of new

standards-related concerns. In several cases, USTR lacked sufficient information about those

concerns at the time of publication to include them in this report. For purposes of this report,

USTR included measures and practices about which USTR is well informed; USTR continues, 

however, to gather information about others. Accordingly, the omission of any issue in this 

report should not be taken to mean that USTR will not pursue it, as appropriate, with the trading 

partners concerned, in the same manner as those listed below. An analysis of the country 

sections of the 2012 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 19 countries, the Central 

American Customs Union, 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.

Toys – Testing and Accreditation Requirements

In 2008, U.S. industry raised concerns regarding Ministry of Health Resolution 583/2008, which

 48 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).
55

limited the amount of phthalates in toys and other children’s products. While the regulation 

applies to all children’s products, it only called for imported children’s products to be tested for 

compliance and accompanied by a technical report from Argentina’s Center for Research and 

Technological Development for the Plastics Industry (INTI). U.S. industry expressed concern 

that there would be significant delays, costs, and burdens in exporting toys and children’s 

products to Argentina based on INTI’s limited capacity to perform testing and its inability to test 

these products in the country of production. 

After the United States raised these concerns bilaterally and in the TBT Committee, Argentina 

issued a temporary measure in May 2010 to increase the efficiency of the new testing process. 

In February 2011, Argentina made the changes permanent, and allowed the products to be sold 

in Argentina if companies have submitted the products for testing to INTI. U.S. industry 

welcomed this improvement. The United States is continuing to monitor conformity assessment 

procedures in Argentina to address any unwarranted barriers to U.S. exports of children’s 

products.

Testing of All Graphic Products for Lead

In October 2011, U.S. industry reported concerns with an Argentine regulation, 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 content at a single laboratory in 

Argentina. Industry noted that that the regulation has been enforced only with respect to 

imported products, the designated Argentine laboratory does not have sufficient capacity to test 

all such materials in a timely manner, and Argentina did not notify the regulation to the TBT 

Committee as required. The United States raised these concerns with Argentina on the margins 

of the November 2011 TBT Committee and asked Argentina to notify the regulation, clarify

whether the regulation will be enforced against domestic products, and allow internationally 

accredited laboratories outside of Argentina to certify compliance with the regulation. 

The United States will continue to press Argentina on this issue in 2012.

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) and the Economic Partnership Dialogue (led 

by Brazil’s Ministry of External Relations and the U.S. Department of State). The United States 

also discusses TBT matters with Brazil during TBT Committee meetings.

Alcoholic Beverages – Labeling and Certification Requirements

In October 2009, Brazil notified the TBT Committee of proposed revisions to its regulations 

governing the labeling of beverages and vinegars. During TBT Committee meetings in June and 

November 2010, the United States raised concerns that some of the proposed revisions could 

potentially prohibit imports of specific U.S.-origin spirits. Specifically, the United States 
56

expressed concerns that the proposed revisions would:

• prohibit alcoholic beverage labels from including abbreviations for common terms; 

• require product names to be printed on the product’s main label in bold face and upper 

case letters; 

• require a large decal to be placed on the label, and the decal must indicate the importer’s 

registration number; and

• bar labels from including certain expressions (such as “home-made,” “hand-crafted,” 

“reserve,” and “special reserve”), even if these expressions are associated with a 

company’s name or trademark.

The United States also asked Brazil to clarify certain elements of its revised regulations, 

including: 

• whether they would restrict the use of fanciful drawings and illustrations that are wellestablished elements of the trademark and clearly not intended to represent an ingredient

of the spirit (e.g., a vodka label with an illustrated “orange” to signify “orange-flavored” 

vodka); 

• whether labels that display a drawing, figure, or illustration of any ingredient used to 

prepare the beverage must indicate all of the ingredients of animal or plant origin, 

regardless of quantity; and 

• the basis for requiring beverage cans or bottles to bear the statement “This container 

must be washed prior to consumption.”

The United States continued to request clarifications and note concerns with the proposed 

revisions during TBT Committee meetings in 2011. In November 2011, Brazil indicated that 

the proposed revisions had been withdrawn and that Brazil is instead working to develop a 

Mercosur standard for labeling of alcoholic beverages. According to Brazil, Mercosur 

discussions on this subject are in the preliminary stages and Brazil has committed to notify the 

TBT Committee of any new labeling measure it proposes to adopt as a result of those 

discussions. The United States is closely monitoring progress by Mercosur countries in 

developing a common labeling standard.

Wine – Certification

In December 2009, Brazil instituted rules requiring certificates of origin and product analyses 

for imported wines, which raise costs for U.S. wine producers seeking to export to Brazil. The 

United States noted in bilateral meetings with Brazil in November 2010 and March 2011 that

these requirements are unnecessary and duplicative because the U.S. Alcohol and Tobacco Tax 

and Trade Bureau issues certificates of analysis of chemical parameters and origin for U.S. 
57

wines. The United States is continuing to work with Brazil to resolve this issue as well as to 

ensure that U.S. wine exports do not face any additional market access restrictions in Brazil.

Medical Devices – Inspection and Registration Requirements

The United States has raised concerns that Brazil’s medical device plant inspection and product 

registration requirements could create market access barriers for U.S. industry. 

These requirements provide that before a medical device may be marketed in Brazil, Brazilian 

authorities must inspect the facility that makes the device, and the manufacturer must register 

the product with Brazilian authorities. In particular, Resolution 25 of 2009, which Brazil 

notified to the WTO on May 18, 2009, required ANVISA (Brazil’s medical device inspection 

agency) to inspect U.S. facilities that produce certain “high risk” medical devices to be sold in 

the Brazilian market by May 22, 2010. The United States does not contest Brazil’s right to 

inspect U.S. facilities; in fact, the U.S. Food and Drug Administration (FDA) has equivalent

authority to conduct inspections of Brazilian and other foreign facilities. The United States

expressed concern, however, that ANVISA would not have sufficient resources to inspect all 

overseas facilities that ship these devices to the Brazilian market by the May 22, 2010, deadline, 

potentially disrupting hundreds of millions of dollars in U.S. exports and jeopardizing the 

adequate supply of essential medical devices to the Brazilian market.

In late 2009 and early 2010, U.S. Government and U.S. industry representatives engaged with 

ANVISA in an attempt to clarify the inspection requirements and seek assurances from Brazil 

that if ANVISA could not complete all of the inspections (and related registrations) in time, 

Brazil would not bar sales of medical devices produced in U.S. plants that had not been 

inspected by the deadline. In response, Brazil clarified that class I medical devices (e.g., tongue 

depressors, bedpans) and class II devices (e.g., powered wheelchairs, surgical drapes) would be 

exempted from the inspection requirement, and that ANVISA’s inspections would apply only to 

the last place of manufacture (as opposed to all the supplier facilities). In addition, Brazil 

indicated that only plants manufacturing devices subject to re-registrations or new registrations 

would need to be inspected by May 22, 2010; products from other facilities could remain on the 

Brazilian market after the deadline pending an inspection. The United States appreciates 

Brazil’s efforts to explain to U.S. industry how its inspection requirements operate and to help 

U.S. producers comply, but remains concerned that Brazil may not be able to carry out its 

inspection regime without impeding U.S. exports to Brazil.

In October 2010, Brazil introduced another obstacle confronting U.S. medical device producers 

that seek to market their products in that country. Specifically, ANVISA issued Technical Note 

No. 001/2010/GGTPS/ANVISA (Requirement of Good Manufacturing Practices and Control

Certificate), which has created a longer path to access the Brazilian market, because it prevents 

GMP plant inspections and product registration from being undertaken in parallel as previously 

was the case. U.S. industry is concerned that this two-step process is delaying the marketing of 

new medical devices in Brazil by over a year due to ANVISA’s backlog of foreign plant

inspections. The United States will continue to monitor the situation closely in 2012 to ensure 

that U.S. exports are not further disrupted.
58

Medical Devices – Data Requirements for Registration

Resolution 185 of 2001, which sets out ANVISA’s registration requirements for medical 

devices, requires manufacturers to submit detailed economic data, including confidential and 

proprietary information. The data requirement does not appear to fulfill a legitimate objective 

related to evaluating medical device safety or efficacy. As explained in the 2011 TBT Report, in 

2009 Brazil committed to U.S. industry that it would not publish any confidential or proprietary 

information.

On September 14, 2010, however, ANVISA unexpectedly published company-specific pricing 

data that individual U.S. producers had supplied. The United States raised concerns regarding

ANVISA’s action with Brazilian officials on the margins of the TBT Committee meeting in

November 2010. Despite the fact that the United States alerted Brazil to its concerns, ANVISA 

published additional U.S. company-specific pricing data on its website in 2011. 

In response, the United States again voiced concerns with Brazil regarding its persistent 

disclosure of proprietary U.S. producer data. The United States noted that Brazil’s disclosures 

fail to protect legitimate commercial interests and conflict with Brazil’s previous assurances that 

it would protect confidential business information. The United States continues to urge 

ANVISA to remove the proprietary data from its website and will continue to monitor the 

situation closely in 2012 to ensure that U.S. exports are not disadvantaged.

Telecommunications – Acceptance of Test Results

Brazil’s National Telecommunications Regulatory Agency (ANATEL) does not accept test data

generated outside Brazil, except in cases where the equipment is too large or too costly to 

transport. Accordingly, U.S. suppliers must submit virtually all of their information technology 

and telecommunications equipment for testing to laboratories located in Brazil before that 

equipment can be placed on the Brazilian market. This requirement results in redundant testing 

to be conducted, and consequently, both higher costs and delayed time to market in Brazil.

In response, the United States has urged Brazil to implement the CITEL (Inter-American

Telecommunication Commission) MRA, which provides 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 equipment to 

the importing country’s technical regulations. The United States and Canada are participants 

within the CITEL MRA. If Brazil implemented the CITEL MRA, it would benefit Brazilian 

suppliers seeking to sell telecommunications equipment into the U.S. market by enabling them 

to use test results from laboratories located in Brazil to certify that their products meet FCC 

requirements. The United States will continue in 2012 to encourage Brazil to implement the 

CITEL MRA.

Products of Animal Origin – Labeling Registration Form

As explained in the 2011 TBT Report, in 2010 Brazil notified the TBT Committee of changes to

its labeling registration form for food products of animal origin. The new registration form 

required the health or veterinary authority of the exporting country to certify that an exporter’s 

establishment is “in compliance” with Brazilian market standards and legislation. When 
59

governments condition access to their markets for animal products on certifications of this 

nature it can raise barriers to U.S. exports as U.S. law does not authorize U.S health and 

veterinary authorities to attest that a U.S. production facility complies with a foreign country’s 

market standards or legislation.

In response to U.S concerns, Brazil revised its registration form in December 2010 so that it no 

longer explicitly requires an exporting country’s health or veterinary authority to certify that 

exported food products conform to Brazilian legislation and standards. The United States 

remains concerned, however, that the revised registration form could still be read to imply that 

the health or veterinary authority is certifying the information provided by the producer. The 

revised registration form is also problematic because it requires producers to provide detailed, 

product-specific information in the form, such as ingredients, additives, and the processing aids 

they use, which could allow competitors to replicate their proprietary formulas. 

In 2012, the United States has engaged in technical exchanges with Brazil with respect to the 

registration form. The United States will continue to work with Brazilian authorities to resolve 

the issue. 

 

Beverage Laboratory Registration

The United States has continued to work with Brazil to resolve outstanding concerns over a 

measure that Brazil notified to the WTO in December 2009. The measure requires the 

government of each exporting country to provide a list of approved production facilities for nonalcoholic beverages, distilled spirits, and malt beverages as well as a list of laboratories that will

test these products to ensure they meet Brazil’s import requirements. The United States is 

concerned that these listing requirements, in addition to impeding trade, are duplicative because 

Brazil already receives certificates of analysis from U.S. exporters as part of normal shipping 

documentation, and these certificates of analysis indicate the laboratory in which the products in 

the shipment have been tested.

These listing requirements, which took effect September 28, 2010, have adversely affected U.S. 

exports; to date Brazilian customs officials have detained at least four shipments of U.S. 

produced vegetable juices and sauces. While officials at the U.S. Agricultural Trade Office in 

Brasilia were able to secure the release of these products, these actions do not provide a basis for 

a viable long-term solution to the problem.

The United States continues to work with Brazil and U.S. industry to identify a solution to 

concerns with respect to these listing requirements.

Chile

Bilateral Engagement

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

Chile Free Trade Agreement, at annual Free Trade Commission meetings, and in the TBT 

Committee. 
60

Emissions Standards

In 2011, the United States worked successfully with Chile to make trade-enhancing changes to a 

Chilean regulation (DS No. 95/2005), which took effect in 2005, but included a clause that 

would have imposed emissions limits for new commercial diesel trucks in Chile beginning on 

January 1, 2012. The clause would have required all commercial diesel trucks sold in Chile to 

meet U.S. Environmental Protection Agency (EPA) 2007 emissions limits for particulate matter. 

Because U.S. diesel trucks engineered to the 2007 EPA standard require low sulfur fuel that is 

not currently available in most parts of Chile, this requirement would have effectively blocked 

U.S. exports of diesel trucks to Chile. 

The United States provided these concerns to Chile in a meeting of the bilateral Free Trade 

Commission in August 2011. In response to these concerns, Chile proposed an amendment to 

its emissions rule to allow new commercial trucks to meet the equivalent of the 2004 EPA 

emissions standard until September 2014, when the appropriate low sulfur fuel is expected to be 

available throughout Chile. The amendment will allow U.S.-manufactured commercial diesel 

trucks to continue to be sold in the Chilean market. 

Chile notified the amended clause to the TBT Committee in February 2012. The amendment is 

scheduled to take effect in April 2012. The United States will monitor developments in 2012 to 

ensure that Chile implements the proposed change.

China

Bilateral Engagement

The United States and China regularly engage on TBT-related issues through the U.S.-China

Joint Commission on Commerce and Trade (JCCT) and bilaterally on a case-by-case basis as

specific market access issues arise. The JCCT, which was established in 1983, is the main forum 

for addressing bilateral trade matters and promoting commercial opportunities between the 

United States and China. The JCCT has played a key role in helping to resolve bilateral TBT

issues, including those related to medical device recalls and registration, certification of 

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 a “Specification for Import and Export of Food Additives 

Inspection, Quarantine and Supervision (2011 No. 52))”. The Specification, which took effect

on July 1, 2011, effectively requires U.S. and other foreign food producers to disclose their 

proprietary food additive formulas. In particular, the Specification requires food product labels 

to list the precise percentage of each food additive. This requirement effectively compels 

producers to divulge their proprietary additive formulas, thus allowing competitors to replicate 

those formulas, and compromise the producers’ legitimate commercial interests. The 

requirement to disclose product formulas appears to apply only to imported food additives. 

Not only does the Specification raise serious commercial concerns, China developed and 

implemented it in a non-transparent manner. Specifically, China did not publish the measure in 
61

draft form and solicit comments from interested stakeholders. Nor did China notify the measure 

to either the TBT Committee or the SPS Committee in advance of promulgating it, as required, 

despite the fact that the measure lists both food quality and food safety as objectives. As a 

result, neither the United States nor U.S. industry stakeholders were aware of the proposed 

Specification, much less able to provide comments on it, 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 take the steps necessary to comply before it took 

effect. 

The United States submitted comments to China in July 2011 regarding the Specification. In its 

October 2011 reply, China claimed that the Specification simply implemented rules set out in its 

existing Food Safety Law, which took effect on June 1, 2009. In September 2009, the United 

States delivered comments on the Food Safety Law to China’s regulators. The United States 

also provided these comments on its Food Safety Law to China’s delegate at the November 

2011 TBT Committee meeting. China also stated in its reply that the measure applied equally to 

domestic products; however, China did not make any revisions to the Specification to address 

concerns over quantitative listing of food additives.

Finally, the disclosure requirements set out in the Specification and China’s Food Safety Law 

appear to conflict with those in China’s 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. This regulatory incoherence has created uncertainty in the trading community.

The United States urges China to revise its rules governing food additive disclosures to better 

comply with international standards and to harmonize its food labeling requirements. 

China Compulsory Certification (CCC) Requirements – Conformity Assessment Procedures

As previously reported, since August 2003 China’s Certification and Accreditation 

Administration (CNCA) has required a single safety mark – the CCC mark – to be used for both 

Chinese and foreign products. As in prior years, U.S. companies continued to express concerns 

in 2011 that the regulations on this subject do not make clear which products require a CCC 

mark. They have also reported that China is applying the CCC mark requirements 

inconsistently and that many Chinese-produced goods that CNCA’s regulations require to bear

the CCC mark continue to be sold without the mark. In addition, U.S. companies in some 

sectors continued to express concerns in 2011 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. When it joined the WTO, 

China committed to provide non-discriminatory treatment to majority foreign-owned conformity 

assessment bodies seeking to operate in China. Despite this commitment, China so far has 

accredited only six foreign-invested conformity assessment bodies. It is not clear whether these 

six bodies play any appreciable role in accrediting products sold in 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. 
62

Because China requires testing for a wide range of products, and all such testing 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, resulting 

in greater expense and a longer time to market. One U.S.-based conformity assessment body 

has 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 2011, 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. During the November 2011 JCCT meeting, 

China indicated that it was actively seeking to improve its testing and certification process and 

that it would hold technical exchanges with the United States about streamlining its system.

WAPI Encryption Standards

The United States has serious concerns regarding China’s 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 Electronics Engineers 

(IEEE). 

In 2009, as part of its plan for encouraging an aggressive roll-out of third generation (3G) 

mobile handsets by Chinese telecommunications operators, many of which employ Internetenabled via WLAN networks, China established a process for approving hand-held wireless 

devices such as Internet-enabled cell phones and smart phones. During bilateral talks in 2009, 

China indicated to the United States that it would approve devices that use the WiFi standard, 

but only if those devices are also enabled with the WAPI standard. China acknowledged that it 

had not published or made available any written measure setting out this requirement and that 

China had not notified the standard to the WTO as required. In 2010, the United States 

continued to urge China to publish the requirement in draft form, notify it to the WTO, allow a 

meaningful time for comments, and take the comments into account in developing any final 

measure.

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, thus indicating that China’s unpublished requirement continues 

to be in force. 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 after 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 IEEE 
63

802.11n standard, which is the wireless LAN industry standard currently used throughout the 

world in Wi-Fi networks. The Chinese UHT/EUHT standard was released for a 15-day public 

comment period on September 20, 2011. MIIT approved the voluntary standard in February 

2012. U.S. industry groups submitted comments, arguing, among other things, that the 

UHT/EUHT standard may not be compatible with either the existing Chinese national standard 

(WAPI) or the widely used IEEE 802.11 standard. Separately, the United States expressed 

concerns to China that, if China integrates the UHT/EUHT standard into its certification or 

accreditation schemes, that standard would become effectively become mandatory and therefore 

could restrict market access for U.S. producers. The United States will vigorously pursue a 

resolution of this issue in 2012.

IT Products – Mandatory Information Security Testing and Certification

The United States has raised serious concerns regarding China’s proposed mandatory 

information security testing and certification requirements for information technology products, 

which were originally planned to take effect in May 2009. In particular, the proposed 

regulations went substantially beyond global norms by mandating testing and certification of 

information security in commercial IT products. In other countries, mandatory testing and 

certification for information security is only required for products used in sensitive government 

and national security applications. 

The United States and other WTO Members expressed serious concerns to China about these 

proposed regulations in numerous bilateral meetings, including during the run-up to the 

September 2008 JCCT meeting, as well as in the 2008 TBT Committee meetings and during 

China’s second WTO Trade Policy Review, held in May 2008. At the September 2008 JCCT 

meeting, China announced that it would delay publishing final regulations while Chinese and 

foreign experts continued to discuss the best ways to ensure information security in China. 

In April 2009, CNCA, AQSIQ, and China’s Ministry of Finance announced that they would 

delay implementing compulsory certification requirements for certain information security 

products until May 2010, and certification would only be required when products are sold to the 

government This step represented a significant reduction in the scope of the requirements from 

China’s original plan. In the run-up to the October 2009 JCCT meeting, China confirmed that 

the compulsory certification requirement would only apply when products are sold to 

government agencies, and would not apply sales to state-owned enterprises or other sectors of 

China’s economy. 

In 2010, the United States continued to meet with Chinese authorities to discuss their regulation 

of information security products. Representatives of China’s State Encryption Management 

Commission (SEMC) confirmed that China was considering revisions to its 1999 encryption 

regulations. The United States noted the earlier widespread concerns about these regulations 

and asked China to ensure that any revisions to these regulations would be published in draft 

form with opportunity for comment by interested parties. In 2011, industry reported that SEMC 

continues to pursue plans to revise the 1999 regulations. During 2012, the United States will 

continue to urge China to use transparent procedures in developing any revisions and to ensure 

that they will not unnecessarily restrict trade in widely-used commercial IT products.

IT Products – Multi-Level Protection Scheme
64

In 2010 and 2011, both bilaterally and during TBT Committee meetings, the United States 

raised concerns with China about its framework regulations for information security in critical 

infrastructure known as the Multi-Level Protection Scheme (MLPS), first issued in June 2007 

by the Ministry of Public Security (MPS) and the Ministry of Industry and Information 

Technology (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. 

A problematic aspect of the MLPS regulations is that they bar foreign products from being 

incorporated into Chinese information systems graded level 3 and above (a grading system 

designed to classify the importance of information handled on an IT system in relation to 

national security, 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 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 its 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, 

and by incorporating level-3 requirements, many RFPs rule out the purchase of foreign products.

Currently, China is applying 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, they could adversely affect sales by U.S. information 

security technology providers in China. The United States has therefore urged China to notify 

the WTO of any MLPS implementing rules laying down equipment-related requirements. In 

addition, 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.

IT Products – Voluntary Standards

The United States has grown increasingly concerned that China may finalize several proposed 

voluntary standards related to information security and integrate them into certification or 

accreditation schemes, thus effectively making the voluntary standards mandatory. 

The proposed standards include the UHT/EUHT standard discussed above in connection with 

China’s WAPI encryption standards, as well as a series of six voluntary information security 

standards released for public comment in July 2011 by the China National Information Security 

Technical Standards Committee. Another voluntary standard, relating to information security 

requirements for office equipment, was released in September 2011, with a 30-day public 

comment period, by the China Electronics Standardization Institute, which operates under 

MIIT’s jurisdiction, in conjunction with the China National Information Security Technical
65

Standards Committee. This voluntary standard appeared to be an office equipment information 

security standard designed to be an alternative to IEEE 2600, an international information 

security standard. 

As in the case of the UHT/EUHT standard, the United States has made clear to China that, if 

voluntary standards such as its proposed office equipment standard are integrated into its 

certification or accreditation schemes, these standards would effectively become mandatory and 

U.S. information and technology products could be barred for China’s market. In the November 

2011 TBT Committee meeting, the United States noted its concern that China may adopt 

voluntary standards in the information and communication technology sector and integrate them 

into certification schemes, without first notifying them to the WTO. China responded by noting 

that both the UHT/EUHT standard and the office equipment standard are voluntary, and are still 

in draft. Further, China indicated that it had taken existing international standards into account 

in formulating its standards (although UHT/EUHT appears to be different from the existing 

802.11n international standard for WiFi computing, and the office equipment standard appears 

to be different from IEEE 2600, an international information security standard for office 

equipment). China also stated that the draft standards are being considered for comment under 

the MIIT process, and that it will take comments into account. 

In 2012, the United States will continue to monitor developments related to China’s draft 

voluntary standards. 

Medical Devices – Conformity Assessment Procedures

The United States has expressed concerns over the past few years regarding Chinese proposals 

governing the registration of medical devices. A draft measure circulated in 2009 would have 

required all medical devices to be registered in the country of export or the manufacturer’s legal 

residence before they could be accepted for registration in China. This requirement had the 

potential to block, or inordinately delay, sales of safe, high-quality medical devices to the 

Chinese market. That is because in some instances manufacturers may decide not to seek to 

have their devices approved in the countries in which they are produced or in the producers’ 

home countries for reasons unconnected with the quality or safety of their products. For 

example, producers may design particular medical devices specifically for patients in a third 

country, such as China, or may choose to produce them in a third country for export only. In 

these situations, a manufacturer would have no business reason to seek to have a particular 

device approved in its home country or the country of export and would likely forego that 

process in order to avoid the associated burdens of time and money.

During the October 2009 JCCT meeting, China indicated that it would not require a medical 

device to be registered in the country of export or in the country of legal residence of the 

manufacturer as part of its approval process for medical devices. However, draft measures of 

the State Council on Supervision and Administration of Medical Devices issued in 2010

maintained the proposed country of export registration requirement. In bilateral discussions 

with China in 2011, including during the 2011 JCCT meeting, the United States continued to 

urge China to meet with stakeholders to discuss their concerns and exclude the registration 

requirement from its final measure. The United States will continue to press this issue during 

2012.
66

In addition, China’s continued failure to permit U.S. suppliers to use competent conformity 

assessment bodies (e.g., testing laboratories, inspection bodies, or product certifiers) located 

outside China to demonstrate that their products comply with Chinese requirements negatively 

affects U.S. exports of medical devices to China. Because China will not accept testing and 

certification results from the United States. U.S. medical device exporters must submit their 

products to Chinese laboratories for tests that have already been performed in the United States, 

resulting in greater expense and a longer time to market.

Classification of Imaging and Diagnostic Medical Equipment

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 also 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 State Food and Drug 

Administration 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 in vitro (e.g., test tube) 

diagnostic equipment catalog for public comment by June 2012. The United States will work to 

ensure that China implements this commitment in 2012.

Patents Used in Chinese National Standards

China has prioritized the development of Chinese national standards, as evidenced by its Outline 

for the National Medium to Long-Term Science and Technology Development Plan (2006-

2020), issued by the State Council in February 2006, and amplified shortly thereafter in the 11th 

Five Year Plan (2006-2010) for Standardization Development, issued by the Standardization 

Administration of China (SAC). More recently, China has also said that when it develops 

standards it will rely on either non-patented technology or patented technology with prices lower 

than those that patent owners would otherwise seek to charge. As a result, China’s treatment of 

patents in the standard setting process has garnered increasing attention and concern around the 

world, including in the United States. 

In November 2009, the SAC circulated for public comment proposed Provisional Rules 

regarding Administration of the Establishment and Revision of National Standards Involving

Patents. The rules would implement China’s vision for a standards development process that 

uses government power to deny or lower royalty payments for patents that are incorporated into 

Chinese national standards. The rules would establish the general principle that mandatory 

national standards should not incorporate patented technologies. However, when those 

standards do incorporate patented technologies, the rules would provide for the possibility of a 

compulsory license if patent holders do not grant royalty-free licenses. Under this approach, 

patent owners may not be able to set reasonable limits on the use of their technology or receive 

reasonable compensation for their inventions. 

The United States provided comments to SAC on the proposed rules in December 2009, asking 
67

SAC to refrain from adopting the rules and consult with stakeholders. SAC reportedly received 

comments from 300 other interested parties as well. The China National Institute for Standards 

(CNIS) published a draft measure containing similar provisions in February 2010. The United 

States provided comments to CNIS on their draft in March 2010. As of March 2012, neither 

SAC nor CNIS had moved to finalize their proposed measures. 

Certification of Pollution Control for Electronic Information Products 

In May 2010, CNCA and MIIT jointly issued a notice proposing to adopt a “National Voluntary 

Certification Program for Electronic Information Products Subject to Pollution Control” 

(“Voluntary Certification Program”). In May 2011, the United States asked China through its 

TBT Inquiry Point to notify the proposed Voluntary Certification Program to the WTO. To 

date, China has failed to do so. 

Information reported in February 2011 indicates that China may incorporate the certification 

procedures set out in the proposed Voluntary Certification Program into mandatory certification 

schemes for products listed in China’s “Standards Compliance Management Catalogue for 

Pollution Control of Electronic and Electrical Products.” More recently, MIIT and CNCA 

indicated that they intend to encourage electronic information product manufacturers, sellers,

and importers to take advantage of the program’s financial and tax incentives, and its priority 

standing in government procurement. According to U.S. industry, MIIT and CNCA intend to 

implement the Voluntary Certification Program in the near future. However, to date China does 

not appear to have published or otherwise described these incentives. U.S. industry is concerned 

that China is encouraging producers to implement potentially costly and burdensome voluntary 

certification procedures, which may not protect their proprietary information, without any 

publicly stated description of the incentives or benefits. U.S. industry is also concerned that if 

China notifies its Voluntary Certification Program to the WTO after the voluntary certification 

procedures in the Program become mandatory, it will be too late for China to introduce 

amendments and take industry comments into account. 

The United States raised concerns with China during and on the margins of the June 2011 TBT 

Committee meeting regarding China’s failure to notify its proposed Voluntary Certification 

Program to the WTO. The United States also urged China to postpone implementing those 

procedures until all interested parties have had the opportunity to submit written comments on 

them and to take these comments and the results of any discussions with those parties into 

account. The United States continues to urge China to clarify the objective and rationale of the 

certification procedures included in the Program and their basis in relevant international 

guidelines and recommendations. The United States also continues to seek clarification from 

China regarding the incentives or benefits that producers may receive for complying with the 

Program’s voluntary certification procedures. The United States will carefully monitor 

developments on this subject in 2012.

Colombia

Bilateral Engagement

The United States discussed TBT matters with Colombia during and on the margins of TBT 
68

Committee meetings.

Distilled Spirits – Quality, Identity and Labeling Requirements

Earlier TBT Reports have outlined U.S. industry concerns about quality and identity 

requirements that Colombia proposed in 2009 for distilled spirits, including gin, rum, vodka, and 

whiskey.

Colombia made positive modifications to its requirements, including by withdrawing a proposed 

measure that would have created standards of identity for distilled spirits based on analytical 

parameters, including their chemical composition. This proposal was problematic because it

could have barred some U.S. spirits from the Colombian market and it was inconsistent with the 

standards of identity for distilled spirits sold in the United States, the European Union, Canada, 

and nearly every other major spirits market. Unlike Colombia’s approach, these markets base 

their standards of identity on the raw materials and processes used to produce distilled spirits, 

not on their chemical composition. 

Although Colombia has withdrawn its draft measure, it continues to endorse imposing analytical 

parameters on the chemical composition of spirits, such as a limit on congeners and other 

naturally occurring constituents of gin, vodka, and rum. Colombia has stated that it will develop 

standards for distilled spirits through other avenues, possibly through Mercosur. Colombia has

also committed to notify any future proposed alcoholic beverage regulations to the WTO. 

Diesel Emissions

The Colombian Government proposed to lower emissions levels from commercial diesel trucks 

for health and environmental reasons. While the United States supports this objective, it has 

raised concerns with Colombia about proposed Resolution 2604, which would specify that 

trucks must meet the Euro IV emissions standard. Given the design of some U.S.-manufactured 

diesel truck engines and the type of fuel available in Colombia, that standard would effectively

exclude many U.S. heavy duty trucks from the Colombian market.

While Colombia has suggested that the Euro IV standard is more stringent than the alternative 

U.S. standard in controlling harmful emissions, it is not clear that the proposed standard will 

result in lower harmful emissions in practice. The United States raised the issue with Colombia 

on the margins of several TBT Committee meetings. The United States has encouraged 

Colombian authorities to focus efforts on removing older trucks from the road to achieve the 

most immediate and significant emissions reductions.

In 2012, the United States engaged in technical exchanges with Colombia on the relative merits 

of the U.S. and Euro IV standards in controlling harmful emissions. The United States will 

continue to engage Colombia on this issue.

Central American Customs Union (CACU)

Bilateral Engagement

The United States discusses TBT matters with the CACU countries (Costa Rica, El Salvador, 
69

Guatemala, Honduras, and Nicaragua) during and on the margins of TBT Committee meetings 

and CAFTA-DR TBT meetings. 

Processed Food – Product Registration

Costa Rica, along with the other CACU countries, requires all processed food products to be 

registered in the exporting country before they are eligible to be imported. A Certificate of Free 

Sale (CFS) is required for registration. That requirement threatened to block U.S. processed 

meat exports to Costa Rica and other CACU countries because the U.S. Food and Drug 

Administration, the agency that issues CFSs in the United States, does not have jurisdiction over 

most processed meat products. 

The United States met with the various national CACU regulatory officials on several occasions, 

including in August 2010 and again in April and July 2011 to bring this issue to their attention. 

The United States also raised this issue in the September 2010 and December 2011 meetings of 

the CAFTA-DR TBT Committee. As a result of engagement by the United States, Costa Rica 

has formally accepted the USDA Export Certificate of Wholesomeness in lieu of a CFS and 

several of the CACU countries have committed to advance discussion in CACU on formal 

acceptance of the USDA Export Certificate of Wholesomeness in lieu of a CFS as well. 

Of further concern are the frequent lengthy delays in registering processed food products with 

the Costa Rican Ministry of Health. Costa Rican importers indicate that the registration process 

ranges from three to six months. The United States has met with the Costa Rican Chamber of 

Food Industry and the Ministry of Health to discuss this issue.

The European Union

Bilateral Engagement

The United States has actively engaged the European Union (EU) on TBT-related matters in 

multilateral fora, including the TBT Committee and in this year’s WTO Trade Policy Review of 

the EU, as well as bilaterally. The United States also uses the Transatlantic Economic Council 

(TEC) and the United States – European Union High-Level Regulatory Cooperation Forum 

(HLRCF) as forums to raise concerns and encourage systemic changes in the EU approach to 

key TBT issues.

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 U.S. and EU 

exporters.

Accreditation Rules

As noted in previous TBT Reports, the United States has serious concerns regarding the EU’s 

accreditation framework set out in Regulation (EC) No 765/2008. The regulation, which applies 

to all sectors, became effective on January 1, 2010. It requires each Member State to appoint a 

single national accreditation body and prohibits competition among Member States’ national 
70

accreditation bodies. The regulation further specifies that national accreditation bodies shall 

operate as public, not-for-profit entities. This means that only a single, government entity in 

each Member State shall be permitted to accredit conformity assessment bodies in the EU.

Because the regulation gives Member States discretion regarding whether to recognize nonEuropean accreditation bodies and whether to accept conformity assessments issued by ILAC 

MRA and IAF MLA accredited bodies, it is possible that Member States may refuse to 

recognize non-European accreditation bodies and refuse to accept conformity assessments 

issued by these bodies. The regulation raises market access concerns for U.S. producers, whose 

products may have been tested and/or certified by conformity assessment bodies accredited by 

non-European accreditation bodies.

The United States raised these concerns at the June 2011 TBT Committee meeting and will 

continue to press the EU on these issues in 2012.

Chemicals – REACH Regulation

REACH, the EU’s expansive chemical regulation, regulates chemicals as a substance, in 

preparations, and in products, and affects virtually every industrial sector, from automobiles to 

textiles. It imposes extensive registration, testing and data requirements on tens of thousands of 

chemicals. REACH also subjects certain chemicals to an authorization process that would 

prohibit them from being placed on the EU market except as authorized for specific uses by the 

European Commission. U.S. industry has expressed specific concerns with the fact that 

REACH requires polymer manufacturers and importers to register reacted monomers in many 

circumstances. This is problematic because reacted monomers no longer exist as individual 

substances in polymers and would not create exposure concerns in the EU. In addition, EU 

polymer manufacturers generally can rely on the registrations of their monomer suppliers and do 

not need to be individually registered. As a result, the reacted monomer registration 

requirement provides an incentive for distributors to stop importing polymers and switch to EU 

polymer suppliers. The United States has pressed the EU to eliminate the requirement to 

register reacted monomers in polymers entering the EU market.

Moreover, REACH contains notification and communication obligations with respect to

substances on the Candidate List, a list of substances that may become subject to authorization.

Differing interpretations between the Commission and several Member States regarding when 

these obligations apply has created uncertainty about how to comply with these obligations. The

Commission has indicated that notification and communication obligations apply if a substance

on the List is present in an article in concentrations above 0.1 percent of the article’s entire 

weight; however, these Member States have stated that these obligations should apply when a 

substance on the List is present in concentrations above 0.1 percent of the weight of the article’s 

components or homogenous parts. In 2010, these Member States pushed the Commission to 

reverse its position as a way of protecting the EU market from imports since a reinterpretation 

would impact imports. A change in interpretation would present a much more difficult 

compliance problem for U.S. industry since it would require companies to perform an analysis 

of individual component concentration levels in their products, which would be extremely timeconsuming 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.
71

Other problematic issues with the EU’s REACH regime include inadequate transparency and

differing registration requirements for EU and non-EU entities.

The United States has raised concerns regarding REACH at nearly every TBT Committee 

meeting since 2003, and has been joined by many other delegations, including Argentina, 

Australia, Brazil, Canada, Chile, China, Colombia, Cuba, the Dominican Republic, Ecuador, 

Egypt, El Salvador,India, Israel, Japan, Korea, Malaysia, Mexico, Qatar, Russia, Singapore, 

Switzerland, Taiwan, and Thailand. The United States also has raised its concerns regarding 

REACH directly with the EU and has worked with the European Chemicals Agency on specific 

technical issues. 

In 2011, the United States registered concerns with the EU during the TBT Committee meeting 

regarding a requirement under REACH rules for manufacturers outside the EU 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 must engage an OR for this purpose. The 

requirement for foreign producers to appoint an OR imposes substantial cost burdens on them 

that European manufacturers do not bear. It can be highly expensive to contract with an OR, 

thus placing an additional financial burden on the exportation of the chemicals to the EU.

The United States also encouraged the EU to address in its 2012 REACH review U.S. concerns 

regarding data compensation issues in connection with the operation of Substance Information 

Exchange Forums (SIEFs) that REACH creates for each registered substance. 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. Under 

REACH rules, other SIEF members must negotiate with the lead registrant to register their 

chemicals. A lead registrant could take advantage of this situation by charging those members 

exorbitant registration fees, thereby driving some companies (especially SMEs) out of 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 2012, and will 

raise trade concerns, as appropriate, in the TBT Committee and other pertinent fora. 

Wine – Labeling Requirements

The EU continues to seek exclusive use of so-called “traditional terms” such as tawny, ruby, 

reserve, classic, and chateau on wine labels, but may allow third country producers to use such 

terms pursuant to an agreement with the EU or contingent on the regulation of those terms in 

their home market. Under the United States – EU wine agreement, the EU permitted the use of 

certain terms on U.S. wines sold in the EU during an initial three-year period, with the 

possibility of an extension for additional two-year periods. At the end of the initial three-year 

period, the EU declined to extend the use of those terms past March 2009. As part of its effort 

to redesign its Common Market Organization on wine, the EU published its new regulation (EC 

No 607/2009) on July 14, 2009, laying down detailed rules for implementation of EC regulation 

479/2008 with regard to protected designations of origin and geographical indication, traditional 
72

terms, labeling, and presentation of certain wine products. 

The United States continues to have serious concerns regarding these measures, which severely 

restrict the ability of non-EU wine producers to use common or descriptive and commercially 

valuable terms to describe their products, on the grounds that those terms are traditionally 

associated with European wines. The United States is also concerned about continued EU 

efforts to expand the list of so-called “traditional terms” to include additional commercially 

valuable terms. Some of these terms do not have a common definition across all EU Member 

States, and the United States is not aware of any effort to monitor or limit the use of those terms 

within the EU. Additionally, the United States remains concerned about the EU’s decision to 

withdraw permission to use certain “traditional terms” under the U.S. – EU wine agreement, as 

well as the EU’s limitation on the use of traditional expressions in trademarks. While the EU 

attempts to justify limitations on the use of traditional terms by indicating that they could be 

used to mislead consumers, these terms have been used without incident on U.S. wines in the 

EU market for many years, which suggests that there is no such risk. In addition, the U.S. 

winemaking industry applied for approval of certain wine terms in June 2010, but the EU has 

delayed making a decision, citing objections to the proposal. During 2012, the United States 

will continue to coordinate with the U.S. wine exporters on how best to address and resolve 

concerns regarding the EU’s wine policy, and will engage with EU officials at the TBT 

Committee and in bilateral meetings.

Distilled Spirits Regulation

The European Union requires that for a product to be labeled “whiskey” it must be aged for at 

least three years. This rule prohibits U.S. whiskey products that are aged for a shorter period 

from being marketed as “whiskey” in the EU market. Recent advances in barrel technology 

have enabled U.S. micro-distillers to reduce the aging time for whiskey produced in the United 

States. In addition, climate can affect the aging process and climate conditions in Scotland and 

Ireland are different from those in the United States. For these reasons, the United States views 

a mandatory three-year aging requirement for whiskey as constituting an unwarranted trade 

barrier. The EU’s policy on distilled spirits also adversely affects U.S. exports to other markets 

that are following the EU’s lead and adopting similar aging rules. Israel and Russia, for 

example, recently adopted the same minimum aging requirement for blended whiskeys as the 

EU – even though those countries do not produce whiskey. In 2012, the U.S. will continue to 

urge our trading partners to end whiskey aging requirements that serve as barriers to U.S. 

exports.

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 or to benefit from RED tax incentives only 

if they qualify for a sustainability certificate. To qualify for this certificate, biofuels and biofuel 

feedstocks must meet specific sustainability criteria and conform to information tracking and 

auditing standards. The RED allows certificates to be issued in three ways: through private 

voluntary schemes authorized by the European Commission (EC), bilateral agreements with 

individual Member States, or bilateral agreements with the EC covering all Member States. The 

EU prefers the use of voluntary schemes. However, not all voluntary schemes are applicable in 
73

all Member States and they include subjective criteria not contained in the RED. In addition, 

not all Member States have integrated the RED into national legislation. The use of separate 

approaches and sustainability criteria has created confusion in the market and has the potential 

to lead to significant trade disruptions.

In order to find alternative approaches to address U.S. concerns with the EU’s certification 

scheme, the United States and the EC have begun 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. In 2012, the 

United States will continue to push for a quick resolution of U.S. concerns and work with the 

EU to conclude a bilateral agreement.

India

Bilateral Engagement

The United States discusses TBT matters with India during TBT Committee meetings and on

the margins of these meetings. The United States also discusses such matters through ongoing 

bilateral engagement, including under the U.S. – India Trade Policy Forum (TPF), the U.S. –

India Commercial Dialogue, and the High-Technology Cooperation Group.

In addition, the U.S. Trade and Development Agency is funding a U.S. – India Standards and 

Conformance Cooperation Program with the Confederation of Indian Industry to facilitate 

India’s development of a transparent and more streamlined system of standards, conformity 

assessment procedures, and technical regulations. 

Cosmetics – Registration Requirements

U.S. industry continues to have serious concerns regarding India’s proposed “Drugs and 

Cosmetics (Amendment) Rules, 2007.” Specifically, industry is concerned that the rules may

subject imports of U.S. drugs and cosmetics to a potentially costly and burdensome registration 

and licensing system. Beyond the administrative costs of conforming to the registration and 

licensing requirements, certain aspects of the requirements, such as in-country testing and 

frequent registration renewals for imported products, could result in delays in bringing U.S. 

cosmetic and pharmaceutical products to the Indian market.

In January 2011, U.S. industry requested additional clarification from India regarding how the 

rules would be implemented. Subsequently, India announced it would delay implementing the 

new regulations until April 1, 2012. The United States has asked India to use this time to 

conduct technical discussions with industry in order to ensure that the rules do not unfairly 

hinder imports into India. 

Food and Distilled Spirits – Labeling

The United States also continued to work with India in 2011 to resolve concerns raised by the 

labeling requirements in India’s Food Safety and Standards Regulation. Aspects of the labeling 

requirements, such as various formatting requirements and a requirement that flavors be listed 
74

on the front of the product container, are inconsistent with the Codex General Standard for the 

Labeling of Prepackaged Foods. One way that India could ensure compliance with these types 

of requirements without imposing undue burdens on producers would be by allowing importers 

to affix supplemental labels in customs bonded warehouses after the products arrive in India 

rather than require that any labeling be done through pre-printing on the product container itself. 

That procedure would allow producers to avoid the costly practice of developing specially 

printed containers for the Indian market. At the June and November 2011 TBT Committee

meetings, the United States supported the European Union in seeking further clarification from 

India regarding whether supplementary labels would comply with India’s requirements. To 

date, India has made available only informal guidance suggesting that supplementary labels may 

comply with India’s measure. 

The United States also remains concerned about India’s requirements that wine and distilled 

spirits labels include an ingredients list and disclose the date the product was manufactured. In 

addition, India has suspended – but not revoked – other potentially onerous labeling 

requirements for wine and spirits, such as “best before” dating requirements. The United States 

continues to seek a permanent exemption from this requirement for wine and spirits.

The United States has repeatedly expressed concerns about India’s labeling requirements for 

wine and spirits through direct engagement with India and in discussions with Indian 

representatives on the margins of TBT Committee meetings. In addition, U.S. regulators met 

with their Indian counterparts in October 2011 to describe U.S. labeling requirements for 

alcoholic beverages, among other subjects. Despite this engagement, India has not been 

responsive to U.S. concerns on this subject. 

The United States will continue to press India to revise its labeling requirements for food and 

distilled spirits in 2012.

Telecommunications Equipment – Information Security Regulations

Over the past several years, the United States and U.S. industry raised serious concerns 

regarding a number of telecommunications security regulations that India’s Department of 

Telecommunications issued, including licensing amendments adopted in December 2009 and 

March 2010, and a “template agreement for security and business continuity” (the “template 

agreement”) issued in July 2010. Under these measures, any vendor seeking to sell foreign 

manufactured telecom equipment and products to Indian telecom service providers was required 

to: (1) deposit its source codes with an escrow agency; (2) transfer its technology to Indian 

companies; and (3) meet burdensome testing and certification requirements. These 

requirements were mandatory for all private commercial contracts between foreign 

telecommunications service providers and vendors of foreign telecommunications-related 

equipment, products, and services in India. However, they did not apply to telecom equipment 

and products manufactured in India. 

These regulations, which India did not notify to the WTO, generated significant uncertainty and 

confusion for the U.S. telecom industry. In response to U.S. concerns on the measures, India 

suspended the use of the “template agreement” and agreed to review its security regulations. 

The U.S. and global telecom equipment industries indicated that India’s security regulations, if 

they had not been halted, would have halted billions of dollars of telecommunications 
75

equipment sales to consumers in India. The United States continued to raise concerns regarding 

these measures in 2010 and 2011. 

India issued revised telecom security regulations to replace the suspended regulations on May 

30, 2011. India failed to notify these revised proposals to the WTO as well. During 2011TBT 

Committee meetings , the United States emphasized its concerns with three specific elements of 

India’s revised telecom security regulations: (1) a requirement to have all imported information 

and communications technology equipment tested in Indian laboratories; (2) a requirement to 

allow the telecom service providers and government agencies to inspect a vendor’s 

manufacturing facilities and supply chain, and to perform security checks of hardware and 

software; and (3) a provision holding vendors strictly liable and subjecting them to possible 

“blacklisting” for taking “inadequate” precautionary security measures. Vendors are especially 

concerned that they could be blacklisted because the regulations do not provide appeal and other 

judicial rights and procedures. The United States will continue to monitor the status of India’s 

revised regulations and seek additional clarifications from India on how they would operate.

E-Waste Rules 

In May 2010, India’s Ministry of Environment and Forests (MEF) proposed new rules for 

managing electronic waste (“e-waste”). The rules broadly apply to producers, dealers, 

refurbishers, and consumers involved in the manufacture, sale, purchase, and processing of 

certain electrical and electronic equipment such as computers, televisions, and cell phones. The 

proposed rules would have:

• required producers of electrical and electronic equipment to collect and channel for 

recycling, refurbishing, or disposal any e-waste created during the manufacture or endof-life cycle of an electronic product;

• permitted only those producers, collection centers, dismantlers and recyclers registered 

with and authorized by India’s Central Pollution Control Board (CPCB) to handle ewaste;

• obligated producers to set up collection centers to oversee product recycling or disposal 

and inform consumers, bulk users, banks, and other businesses of the location of 

recycling or disposal facilities; 

• required producers to ensure that the dismantlers or recyclers with which they work are 

registered with the CPCB; 

• required producers to take responsibility for handling “historical waste” (the e-waste 

produced before the proposed rules took effect); and 

• placed limits on the use of 20 “hazardous substances,” including beryllium metal, copper 

beryllium alloys, liquid crystals, and mineral wools. 

Following U.S. engagement with India in 2010, India notified the proposed rules to the TBT 
76

Committee and provided stakeholders an opportunity to provide comments. The United States 

actively conveyed U.S. industry’s concerns, including during the March 2011 TBT Meeting.

In May 2011, MEF issued a new set of e-waste rules that are scheduled to go into effect on May 

1, 2012. In respect to these new rules, India’s representatives have stated that MEF took into 

account some of the comments received from stakeholders. For example, the revised rules 

reduced the number of hazardous substances subject to use restrictions from 20 to six. In 

addition, India narrowed the rules to cover only information technology and telecommunications 

equipment (e.g., computers, printers, and cellular phones) and certain consumer electronics (e.g., 

television sets, refrigerators, and washing machines). Despite these improvements, U.S. 

industry continues to have concerns about whether India’s rules will require producers to 

divulge proprietary information and about the apparent lack of mechanisms under the rules to 

assist small and medium enterprise (“SME”) producers in processing their e-waste.

Toy Registration

India’s Bureau of Indian Standards has proposed a “Toys and Toy Products (Compulsory 

Registration) Order” that would impose additional testing requirements on toys manufactured 

abroad. Under the proposed order, foreign manufacturers would only have 45 days to 

demonstrate that their toy products comply with the proposed testing requirements.

The proposed rule also appears to establish a new registration procedure that will require foreign 

toy producers to provide detailed and burdensome information related to toy manufacture. The 

information includes data on each factory’s management composition, raw materials used in toy 

production, factory components, production machinery (including the serial numbers for all 

equipment on the factory floor and notification whenever particular equipment is removed from 

the factory, even for maintenance), factory layout, production processes, packing and storage 

procedures, product testing and inspection, and details concerning the producer’s quality control 

staff. 

In May 2011, the United States requested India to notify the proposed toy order to the WTO as 

required. The United States also asked India to postpone implementation of the order until all 

interested parties have had an opportunity to submit written comments and the Indian 

government has had an opportunity to consider those comments. As of March 2012, India had 

yet to notify the proposed toy order to the TBT Committee. 

At the June and November 2011 TBT Committee meetings, the United States raised U.S. 

industry’s concerns regarding the proposed order, including India’s failure to explain why it is 

planning to require such detailed information for its proposed registration system and how India 

intends to keep the information confidential. The United States also noted that India’s proposal, 

in contrast to U.S. and international best practices, would establish a de facto in-country testing 

requirement. The United States explained that India’s safety objectives could be satisfied by 

less trade-restrictive approaches such as recognizing test results from internationally recognized 

laboratories, including those accredited under the International Laboratory Accreditation 

Cooperation Mutual Recognition Arrangement (ILAC MRA). 
77

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. 

Indonesia also participates actively on standards and conformance issues through APEC.

Processed Foods - Bahasa Labeling Requirement

In September 2010, Indonesia’s National Agency for Drug and Food Control (BPOM) 

announced that beginning March 1, 2011, 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 before they are shipped to Indonesia. The proposed policy at a minimum would have

significantly raised costs for U.S. industry and at worst, could have shut U.S. exports out a 

market valued at $429 million on an annual basis. 

In 2011, the United States raised its concerns with Indonesia both bilaterally and in TBT 

Committee meetings. In response to objections from the United States, Indonesia agreed to 

delay enforcing it labeling requirements until March 1, 2012. Also in response to U.S. concerns, 

Indonesia agreed to accept supplemental Bahasa language labels in lieu of original Bahasa 

language labeling. Indonesia has not clarified, however, whether the supplemental labeling 

must be completed before importation. In 2012, the United States will continue to press 

Indonesia to either lift its new labeling requirements, or allow the sale of processed food 

products with supplemental labeling that are applied in Indonesia.

Food, Supplements, Drugs, and Cosmetics – Distribution License Requirements

BPOM is considering licensing requirements for companies that distribute of food, health food 

supplements, drugs, and cosmetics in Indonesia, including imported products. Although the 

proposed licensing requirements vary by product type, they generally impose requirements that 

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 that the production process for the product 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. In 2012, the United States will continue to raise its remaining concerns with 

the proposed licensing requirements.

Toy Certification

Indonesia’s Directorate General of Manufacturing Industries is proposing to enforce in 2012 a 

recent 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 at the November 2011 TBT Committee meeting. The 
78

United States also urged the Government of Indonesia to notify the draft measure to the WTO 

and to allow interested parties a reasonable period to submit comments on the standard. The 

United States is also encouraging Indonesia, in lieu of in-country testing, to instead allow 

foreign suppliers to provide laboratory test reports that are accredited by the International 

Laboratory Accreditation Cooperation (ILAC). The United States noted that recognition of test 

results from ILAC-accredited labs is common international practice in the toy safety area. 

Accepting ILAC reports could help prevent market-access delays without compromising 

regulatory effectiveness. In addition, accepting reports from ILAC accredited facilities could 

reduce the burden on local testing and certification facilities, which appear to lack the capacity 

to test imports in a timely fashion. 

Indonesia is also considering another standard, SNI ISO 9001:2008, under which certain 

products such as toys, would be eligible for a mark that the product satisfies the safety 

requirements that Indonesia’s National Standardization Agency has established. In 2011, the 

United States asked Indonesia to clarify whether it will recognize a certification that a product 

conforms to ISO 9001, a standard adopted by the International Organization for Standardization, 

as equivalent to SNI ISO 9001:2008 for purposes of receiving an SNI mark. The United States 

also asked Indonesia to clarify whether the SNI mark is intended to be placed on the product 

itself or the product packaging and whether certain reports were correct in stating that fees for 

obtaining the mark would be higher for imported products than for domestic products.

Indonesia has responded that its regulations on toy safety are in the preparatory stages and thus 

it was not in a position to address these questions. Indonesia assured the United States that it 

would notify any final toy safety regulatory proposals to the WTO. The United States will 

remain engaged on this subject as Indonesia develops its regulations.

Japan

Bilateral Engagement

The United States discusses TBT issues with Japan bilaterally, including through the U.S. –

Japan Economic Harmonization Initiative (EHI) established in November 2010, as well as in 

multilateral fora such as the TBT Committee. 

Organic Product Requirements

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. U.S. organic standards permit producers to use these 

substances, but Japan requires producers to confirm that the neither substance has been applied 

before a product is exported to Japan. The United States engaged Japan on this issue in 2011, 

including by providing Japan in November 2011information it had requested on these 

substances. 

In addition, Japan’s national organic labeling requirements impose a zero tolerance policy for 

pesticide and herbicide residues on organic products. These requirements are problematic for 
79

U.S. industry since these substances are often present in the natural environment. Japan’s 

labeling policy also appears be inconsistent with the Codex Guidelines for the Production, 

Processing, Labeling and Marketing of Organically Produced Foods. These guidelines apply to 

the process by which organic foods are produced, and do not mandate specific maximum residue 

levels for pesticides and contaminants.

In response to U.S. concerns, Japan’s Ministry of Agriculture, Forestry, and Fisheries (MAFF) 

is continuing its process of reviewing and revising Japan’s certification requirements for organic 

products. During bilateral discussions in 2011 under the EHI, the United States presented 

alternative regulatory language on residue tolerances for MAFF to consider. MAFF is 

scheduled to complete its review process by the end of 2011. The United States will review the 

outcome of that process to ensure U.S. industry’s concerns are conveyed. 

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 thereby putting 

U.S. exporters at a disadvantage. Moreover, Japan only allows JAS accredited certifiers to issue 

the logo, which would require an additional accreditation for certifiers.

The United States will continue to press Japan in 2012 to modify its organics standards in a 

manner that will 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 Beverage Labeling

In March 2011, Kenya notified to the WTO regulations that imposed labeling requirements for 

alcoholic beverages. The labeling requirements, which are presently in suspension as a result of 

domestic litigation, could prove onerous to U.S. exporters if they go into effect. For example, 

they require a warning message that comprises at least 30 percent of the package’s total surface 

area. There is also a possibility that pictorial warnings will be incorporated as well. The United 

States will continue to closely monitor this issue. 

Korea

Bilateral Engagement

Korea and the United States regularly discuss TBT issues through bilateral consultations. These 

consultations, led by USTR on the U.S. side with participation from other U.S. agencies, serve 

as an important forum for discussing and resolving these issues and are augmented by a broad 

range of senior-level policy discussions. In 2011, bilateral trade consultations were held in May 

and September leading to the resolution of a number of TBT issues. In addition, the United 
80

States raises TBT issues with Korea during and on the margins of TBT Committee meetings. 

Opportunities for bilateral engagement on TBT issues will increase through the work of 

consultative mechanisms, such as a bilateral TBT Committee and an Automotive Working 

Group, established under the United States – Korea Free Trade Agreement, which entered into 

force on March 15, 2012.

Alcoholic Beverages – Radio Frequency Identification Tag

The Korean National Tax Service announced in July 2011 that it will begin requiring imported 

whiskey bottles to carry a radio frequency identification tag (RFID). Among the purposes for 

the tags is to prevent counterfeited products and tax evasion. Imported products must comply 

with the regulation by October 1, 2012. (Korea applied the requirement to domestic brands in 

2010.) The United States submitted comments to Korea on the measure in July 2011 and 

February 2012. U.S. industry has expressed concerns that the requirement will impose 

significant costs and burdens on whiskey producers, such as the installation of RFID readers in 

warehouses and costs associated with the purchase and application of the RFID tags. The 

United States has urged Korea in bilateral meetings as well as through the TBT Committee to 

consider less burdensome options. 

Cosmetics 

In December 2010, Korea notified the WTO of a regulation it proposed to adopt on certifying 

cosmetic products that satisfy Korea’s standard for Good Manufacturing Practices (GMPs). 

GMPs are a set of principles that producers should observe during the manufacturing process in

order to ensure consistent product quality. A GMP certification attests that a product has been 

produced in a manufacturing facility that abides by certain quality control principles. 

Although the proposed regulation does not appear to be mandatory, it raises national treatment 

concerns since it appears solely to allow domestic manufacturers to qualify for GMP 

certification. Companies recognized as complying with Korea’s GMP standard will be granted 

preferential treatment, such as not being required to test every batch of cosmetics, a highly 

expensive process. Given the advantages of obtaining the GMP certification, the United States 

urged Korea to apply its GMP certification regime equally to foreign and domestic producers. 

Korea has indicated that it will seek to modify the regulation to allow foreign manufacturing 

facilities to qualify for GMP certification. The United States will monitor this process closely. 

Furthermore, as the GMP standard that Korea is considering is based on an international 

standard, ISO 22716, the United States has urged Korea to allow products to be GMP certified if 

independent third parties have certified that they meet the ISO standard.

In April 2011, Korea also notified the WTO of its draft “Guideline for Cosmetics Labeling and 

Advertising.” The draft guideline lists the types of claims that producers can include on labels 

and in advertisements for cosmetics products. U.S. industry has raised two concerns with the 

guideline. First, industry is concerned that since regulations from Korea’s Fair Trade 

Commission as well as Korea’s product liability law already address personal care products, 

new guidelines for cosmetics labeling and advertising will be redundant and confusing. Second, 

U.S. industry has noted that Korea has yet to explain whether a procedure exists by which a 

manufacturer could assert a performance claim about a product that is not found in the proposed 

guidelines. The United States has raised these concerns bilaterally as well as during the 
81

November 2011 TBT Committee meeting. Korea has indicated that it will revise the draft 

guideline in consultation with stakeholders, a process that the United States will follow closely. 

Korea Chemicals Registration – REACH 

In February 2011, Korea’s Ministry of Environment (MOE) released a draft of a proposed “Act 

on the Registration and Evaluation of Chemicals.” As announced, Korea REACH would create 

a complex registration system for chemical products, perhaps as early as 2014. U.S. industry 

has expressed concerns about the burden and lack of clarity about Korea’s proposal. The United 

States seeks to ensure that Korea’s final requirements are not unnecessarily trade-restrictive. 

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. The 

United States will continue to monitor developments related to the proposed registration system 

and press Korea to take U.S. industry’s comments into account. 

Organic Products – Requirements and Conformity Assessment Issues

In June 2008, Korea published a proposed Processed Organic Foods Regulation, with a target 

implementation date of January 1, 2010. As originally drafted, the regulation would have 

required all products claiming to be organic to be certified as such by a body accredited by 

Korea’s Ministry for Food, Agriculture, Forestry and Fisheries (MIFAFF). Many U.S. 

producers and certifiers would have been reluctant to seek certification and accreditation under 

the proposed regulation, due to the difficulty of finding certified ingredients that comply with 

the requirements, such as zero tolerance for materials prohibited by the regulation. Furthermore, 

because the proposed Korean regulation does not currently provide for Korea to negotiate 

agreements for equivalency or recognition of foreign organics programs, the proposed 

certification requirements could have significantly impeded, or even halted, more than $10 

million worth of U.S. organics exports to Korea. 

In response to concerns raised by the United States and other exporting countries, MIFAFF 

agreed to allow foreign organic products to be sold in Korea until December 31, 2012 without 

having to be certified by a MIFAFF-accredited certifier. During this interval, MIFAFF is 

revising and consolidating its organics regulations, including through a provision that will allow 

for the possibility of concluding equivalency agreements. The United States will actively 

pursue negotiations with Korea on an equivalency agreement 2012 with a view to concluding an 

arrangement that will facilitate exports of U.S. organic products.

PVC flooring 

The Korean Agency for Technology and Standards has proposed to establish a content limit for 

certain industrial compounds known as phthalates that would effectively prohibit their use in 

PVC (polyvinyl chloride) flooring and wallpaper. The phthalates at issue are DBP, BBP, and 

DEHP, which are used as plasticizers in vinyl flooring and wallpaper in order to make them 

flexible, durable, and easy to maintain. Although the United States and other countries restrict 

the use of phthalates in children’s toys and child care articles where there is concern that their 

use could result in potentially high exposure to children, it is not clear that such limits are 

necessary for flooring and wallpaper. 
82

The United States has raised concerns with Korea over its proposed limits on the use of 

phthalates in PVC flooring on multiple occasions, including bilaterally and during the March, 

June, and November 2011 TBT Committee meetings. Korea has responded to U.S. concerns by 

citing a study that suggests that PVC flooring installed in Korean buildings may release 

phthalates because those buildings often have heated floors. Korea has not shared a copy of the 

report, despite requests to from the United States to do so. 

Radio Waves Act 

U.S. industry has been working closely with Korea’s Radio Research Agency on the 

implementation of a 2011 amendment to Korea’s Radio Waves Act. The amendment requires 

broadcasting and communication equipment to confirm compliance with Korean conformity 

assessment criteria, including safety standards, through the use of labeling. U.S. industry has 

expressed concerns that the amendment may require manufacturers to place labels on products 

in a manner that will adversely affect their performance. The United States will continue to 

work with Korea in 2012 to ensure that it takes U.S. industry’s concerns into account.

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 Korea’s private marketplace. The United States asked Korea bilaterally 

and at the March, June, and November 2011 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. That would both facilitate trade and afford Korean consumers 

access to the best available technologies. In response to U.S. concerns, Korea is conducting an 

environmental impact review on the use of cadmium in solar panels, which is expected to be 

completed in the first quarter of 2012. Korea has said it will consider revising its certification 

standard based on the results of that study. The United States will continue to press this issue 

with Korea in 2012. 

Malaysia

Bilateral Engagement

The United States discusses TBT matters with Malaysia during TBT Committee meetings,

bilaterally on the margins of those meetings, and during TPP negotiations. Malaysia also

participates actively on standards and conformance issues through APEC.
83

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. Indonesia 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. In an effort to 

position Malaysian certification as the “gold standard” for halal products, MS1500: 2009 creates 

standards that go beyond the internationally recognized halal standards, which are contained in 

the Codex Alimentarius. The guidelines require slaughter plants to maintain dedicated halal

production facilities and ensure segregated storage and transportation facilities for halal and 

non-halal products. These requirements appear to far exceed Codex guidelines, which allow for 

halal food to be prepared, processed, transported, or stored using facilities that have been 

previously used for non-halal foods, provided that cleaning procedures meeting Islamic 

religious requirements have been observed. The stringent new Malaysian guidelines could 

curtail or even block exports of U.S. beef and poultry products to Malaysia. 

In spring 2011, Malaysia notified the WTO of a new protocol that 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. Malaysia has not yet addressed 

these concerns. 

Following a request from the United States for further clarity on the new halal protocol, U.S. 

and Malaysian government representatives met in the United States in February 2012 to discuss 

the matter. Among other things, Malaysia’s representatives noted that the while the protocol 

would be applied to permit mechanical slaughter, meat processing would have to take place in a 

dedicated halal facility. In addition, Malaysia’s representatives said that U.S. producers could 

not meet Malaysia’s halal standards by having their facilities audited on a systemic basis rather 

than plant-by-plant. 

U.S. industry estimates that U.S. exports to Malaysia of halal beef and poultry could increase 

dramatically if Malaysia harmonizes its halal production standards and import licensing 

practices with the international norms contained in the Codex. The United States will continue 

to pursue this issue with Malaysia to find a mutually agreeable solution. 

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 as part of the U.S. – Mexico High-Level Regulatory Cooperation Council, 

which was established in 2010 and in the NAFTA Committee on Standards-Related Measures.
84

Caffeinated and Flavored Beverages 

During the November 2011 TBT Committee meeting, the United States expressed concern over 

draft Mexican legislation that would restrict the sale of certain caffeinated energy drinks. In 

December 2011, Mexico published a revised legislative draft. The United States is currently 

reviewing this draft and will continue to engage in discussions with Mexico regarding any 

potential restrictions in 2012. 

In January 2011, Mexico notified the WTO of a draft standard for non-alcoholic flavored 

beverages. The standard appears to impose design and sanitary requirements. The United 

States submitted comments on the draft standard to Mexico through the TBT Committee in 

August 2011. Specifically, the United States sought clarification on a number of issues, 

including the standard’s documentation and recordkeeping requirements, the list of approved 

additives, and new mandatory advisory statements on the product containers. During the 

November 2011 TBT Committee meeting, Mexico stated that it was considering the comments 

the United States had submitted on the draft standard and that it would include responses to 

those comments in the final rule at the time it is published.

The United States will continue to engage with Mexico on both of these issues during 2012 to 

address U.S. beverage industry concerns regarding these measures.

Energy Efficiency 

In September 2010, Mexico’s Secretariat of Energy published a catalog of electrical equipment 

and appliances that 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 

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. Although Mexico let the catalog take effect, it did engage with U.S 

industry to clarify the catalog’s requirements. In 2012, a bilateral working group will be formed 

in order to address industry concerns.

Sanitation Pipes

Mexico’s drainage and sewage pipe market includes three types of pipes: cement pipes; 

corrugated high-density polyethylene (HDPE) pipes (manufactured mostly by U.S.-based 

companies); and PVC (polyvinyl chloride) pipes (manufactured mostly by Mexican-based

companies). 

Mexico’s National Water Commission (NWC) imposes a certification requirement that keeps 

U.S. HDPE pipes off the Mexican market. Specifically, Mexico requires sanitation pipes to 

meet a particular ISO standard. This standard addresses design and descriptive characteristics 

for particular pipes rather than performance abilities. Only PVC pipes meet these design and 

descriptive characteristics. Whether HDPE pipes would perform adequately for sanitation 

purposes is irrelevant under this standard. NWC will not allow U.S. HDPE pipes to be 
85

recertified as meeting the Mexican standard.

The ISO standard is not codified in Mexican law and U.S. HDPE pipe producers learned that 

NWC intended to apply it when NWC denied their requests for recertification in February 2010. 

During the November 2011 TBT Committee meeting and in separate bilateral discussions, the 

United States asked Mexico to ensure that the standards NWC adopts are applied on a nondiscriminatory basis, are science-based, and are developed through the transparent processes the 

TBT Agreement requires. The United States will continue to press Mexico regarding this issue 

in 2012.

Russia

Russia is a member of 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 at the CU or EurAsEC level as well as at the 

national level. The CU parties, all members of EurAsEC, have agreed to harmonize their 

policies and regulatory systems in the TBT arena. 

Bilateral Engagement

The United States engages directly with Russia regarding its technical regulations, standards, and

conformity assessment procedures on a bilateral basis. (Once Russia joins the WTO it will be 

required to adhere to the TBT Agreement). In addition, the Working Group on Business 

Development and Economic Relations established under the U.S. – Russia Bilateral Presidential 

Commission provides a forum for the United States and Russia to discuss, among other matters, 

standards-related regulatory cooperation.

Alcoholic Beverages – Tax Strip Stamp Requirement

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. In February 2010, Russia 

amended its laws to make domestic alcohol imported alcoholic beverages subject to the same 

excise stamp labeling requirement. Although Russia’s harmonization of its strip stamp 

requirements represents a significant improvement over its previous system – which accorded 

different treatment to imported and domestic products – U.S. industry has indicated that 

Russia’s strip stamp requirements remain burdensome. Russia’s United Federal Automated 

Information System (UFAIS) requires importers and domestic manufacturers to print Universal 

Product Code data on each strip stamp. In addition, the stamps must be sequentially-numbered, 

and suppliers must prepare a consolidated document at the end of the year for all the strip stamp 

numbers. Further, suppliers and importers must report these stamps through an automated 

system for purposes of taxation and a manual system for customs purposes. U.S. government 

reports indicate that the UFAIS requirements are expensive to fulfill, difficult to use and, thus 

far, have been unsuccessful in meeting the objective of tracking alcohol from manufacture or 

importation to the retail sales point.

Russia has recently taken steps to extend the strip stamp requirement to cover all alcohol 

products (except beer and beer drinks), including products below 9 percent alcohol by volume 

(abv). Russia has provided a grace period for domestic products that contain 9 percent abv or 
86

less ending on January 1, 2013. Imports of those products were made subject to the strip tax 

requirement on January 1, 2012. 

Finally, Russia is considering establishing a single point of entry for imports of alcoholic 

beverages in order to ensure that importers comply with Russia’s excise stamp requirements. As 

approximately 700 million units of alcohol are imported into Russia every year, this requirement 

would cause significant trade delays. In 2012, the United States will continue to urge Russia to 

revise its strip stamp requirements in ways that will facilitate access for imported alcoholic 

products to Russia’s market.

Alcoholic Beverages – Warehousing Requirements

In October 2010, Russia’s Federal Service for Alcohol Market Regulation (FSR) adopted 

regulations governing the warehousing of alcoholic beverages. The United States is concerned 

that these regulations impose onerous and unfounded restrictions on this practice. For example, 

the regulations prohibit storing different types of alcohol on one pallet; require that alcohol 

products be stored at least 15 cm from the floor; and preclude other goods from being stored 

with alcohol products. It is unclear what objectives these requirements are intended to fulfill. 

Furthermore, the regulation unnecessarily restricts access to the Russian market for U.S. 

alcoholic beverage exporters. Several U.S. exporters have experienced months of delays 

seeking to bring their warehousing practices into conformity with the regulation after FSR 

inspections raised compliance issues. In 2011, U.S. and Russian [alcoholic beverage] regulators 

met to discuss U.S. concerns over Russia’s warehousing requirements. Those discussions were 

productive and Russia released a new draft of the alcoholic beverage regulation was released in 

October 2011, which included helpful changes. 

Alcoholic Beverages – Definition of Beer

In June 2011, Russia amended its alcoholic beverages law in a way that changed the scope of 

products that can be sold as “beer” in Russia. Among other things, the amendment allows beer 

to be brewed from no more than 20 percent brewing malt in grain form. It appears that products 

from most of the larger U.S. brewers are precluded from being marketed in Russia as beer under 

the new definition. Moreover, other products often marketed as beer in the United States, such 

as flavored malt beverages, seasonal beers, sake products, and many craft beers would not be 

considered beer under the new law as well. In October 2011, the Customs Union published 

similar draft technical regulations. In December 2011, the United States submitted comments to 

the Customs Union raising U.S. concerns over proposed beer definition. The United States will 

continue to address this issue in 2012.

Saudi Arabia

Bilateral Engagement

The United States engages with Saudi Arabia on TBT issues through the bilateral Trade and 

Investment Framework Agreement and during TBT Committee meetings.
87

Conformity Assessment Procedures – Lack of Transparency

In 2006, Saudi Arabia introduced a Certificate of Conformity (CoC) Program. With certain

exceptions, this program requires every shipment of products sold in Saudi Arabia to be 

accompanied by a document certifying that the product conforms to the relevant Saudi technical

regulation (“conformity certificate”). U.S. exporters have expressed concern about a lack of 

detailed public guidance in English on how to comply with this requirement. In course of 

discussions in bilateral discussions in 2010 and 2011, officials from the Saudi Arabia Standards 

Organization (SASO) clarified that this guidance is now included in the “Procedures of Issuing 

Certificate of Conformity for Commodities and Products to be Exported to the Kingdom of 

Saudi Arabia” as well as other documents available on SASO’s website.

South Africa

Bilateral Engagement

The United States discusses TBT matters with South Africa during TBT Committee meetings 

and bilaterally on the margins of these meetings, as well as under the U.S.-South Africa trade 

and investment agreement. USDA and South African agriculture officials discuss TBT matters 

through their annual bilateral forum.

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 by alcohol content. The two main classifications 

are liqueurs and spirit coolers. South Africa classifies “liqueurs” as beverages having a 

minimum alcohol content of 24 percent and classifies “spirit coolers” as beverages having 15 

percent or less alcohol by volume. On the other hand, South Africa does not maintain any 

classification for spirit-based alcoholic beverages with an alcohol content of between 15-24 

percent, with the exception of products that fall into the “Cream Liqueur” classification, namely 

spirit-based alcoholic beverages that contain a dairy product. As a result, any U.S. products that 

fall in the gap between these two classifications cannot be sold in South Africa.

Not only have these requirements kept certain U.S. products out of the market, but industry has

reported that South Africa may not be applying its requirements equally to domestic and

imported products. In particular, U.S. industry has reported that South Africa has granted at

least one exception to its requirements for a domestic producer.

During 2012, 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.
88

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 U.S.-Taiwan 

TIFA. 

Ceiling Panels – Requirements for Incombustibility Testing Methods

U.S. companies that manufacture finished interior building materials, such as ceiling panels and 

wood paneling, have raised concerns regarding the testing method that Taiwan mandates for 

determining whether those materials meet applicable incombustibility requirements. Industry 

has complained that Taiwan’s current testing method for ceiling panel incombustibility, which is 

similar to the current ISO 5660 standard, results in inconsistent and inaccurate incombustibility 

measures because the ISO standard was not meant to be applied to the testing of ceiling tiles.

As a result, ceiling tiles manufactured in the United States are given a lower incombustibility 

rating than is otherwise warranted and, in some instances, fail the test altogether. An ISO 

committee has been working to develop a new version of ISO 5660 that would incorporate a 

testing apparatus taking into account inconsistencies in the current methodology.

The United States raised these concerns with Taiwan on the margins of the TBT Committee 

meeting in November 2009, as well as in subsequent bilateral meetings under the TIFA, 

including a meeting held in Taiwan in September 2011. In response, Taiwan’s Bureau of 

Standards, Metrology, and Inspection has indicated it would consider adopting the new ISO 

standard when it is approved. In the meantime, Taiwan has indicated that it is open to accepting 

alternative approaches. The United States will continue to encourage Taiwan to adopt the 

relevant international standard when it is completed. 

Commodity Goods – Labeling Requirements

U.S. industry continues to express concern that Taiwan requires all “commodity goods” 

(consumer goods, in U.S. parlance) to be labeled with the manufacturer’s or producer’s name, 

telephone number, and address. In addition to concerns over protecting proprietary information, 

industry notes that some commodity goods may be produced by several different manufacturers, 

and product labels may not be large enough to contain all of the required information. U.S. 

officials have raised these concerns with Taiwanese representatives, including on the margins of 

the TBT Committee meetings as well in staff-level meetings under the TIFA, including in 

September 2011. Taiwan is working to revise the relevant labeling requirements for textiles, 

garments, and 3C (computer, communication, and consumer electronics) information products. 

The United States will continue to monitor Taiwan’s progress in addressing this issue.

Thailand

Bilateral Engagement

The United States discusses TBT matters with Thailand during, and on the margins of, TBT 
89

Committee meetings as well as in bilateral dialogues such as the U.S. - Thailand TIFA Council 

and the Bilateral Consultative Mechanism. Thailand also participates actively in APEC on 

standards and conformity assessment issues.

Alcoholic Beverages – Labeling Requirements

In January 2010, Thailand notified the WTO of a proposed regulation that would require alcohol

beverage labels to include warning statements and photo images. The images would graphically

depict certain potential adverse consequences of consuming alcohol, such as road accidents and

diseased organs. The draft regulation also specifies that at least 50 percent of one side of square

shaped packaging, or 30 percent of round or cylindrical shaped packages, must be allocated for

the warning statements and images. In addition, the draft regulation calls for the various sets of

warning labels and images to be rotated every 1,000 packages.

Following engagement with Thailand on this issue in 2010, the United States raised concerns 

about the draft regulation during all three 2011 TBT Committee meetings. Australia, Brazil, 

Chile, the EU, Mexico, New Zealand, and Switzerland expressed concerns as well. In its 2011 

interventions, the United States continued to express concerns that the proposed size of the 

warning label in proportion to the size of the container would interfere with displaying 

legitimate trademarks and useful consumer information on alcoholic beverage containers, such 

as information necessary to distinguish one product from another. The United States also 

indicated that the requirement to rotate warning statements every 1,000 bottles could impose an 

onerous and potentially trade restrictive burden on producers, and was potentially unnecessary 

to achieve Thailand’s objective of addressing the harms associated with alcohol consumption. 

In light of the scale of the proposed changes, the United States asked Thailand to lengthen the 

implementation period for the regulation. 

Thai officials have indicated that an inter-agency subcommittee is examining the proposed 

regulation, which will submit recommendations to the Thai committee responsible for the 

approval process. Thai official have indicated that the regulation will not be implemented while 

it is under review. The United States will continue to monitor all developments related to this 

issue.

Food Additives 

In August 2011, Thailand notified the WTO of new rules for food additives (i.e., ingredients that 

preserve flavor or enhance taste and appearance) that would require food product labels to list 

all the additives and their percentages by weight. In comments delivered in October 2011, and 

during bilateral discussions with Thailand on the margins of the November 2011 TBT 

Committee meeting, the United States expressed concern that Thailand’s requirement for 

producers to specify the percentage of each food additive would reveal proprietary information 

and is unneeded to ensure food safety. In addition, the United States highlighted that Section 

4.2 and 5.1 of the Codex General Standard for the Labeling of Prepackaged Foods calls for food 

ingredients and additives to be listed by quantity only in certain cases, such as when they are 

featured on the product label, , not in all cases , as Thailand’s measure appears to require. The 

United States will continue to work with Thailand during 2012 to resolve issues concerning its 

additive disclosure requirement. 
90

Turkey

Bilateral Engagement

The United States discusses standards-related issues with Turkey during TBT Committee 

meetings and bilaterally on the margins of those meetings. The United States also discusses 

these issues in consultations through the U.S.-Turkey TIFA and in the newly established 

bilateral ministerial level Framework for Strategic Economic and Commercial Cooperation 

(FSECC). The FSECC is co-chaired on the U.S. side by the U.S. Trade Representative and the 

U.S. Secretary of Commerce and on the Turkish side by the Turkish Deputy Prime Minister and 

the Minister of Economy. The FSECC is designed to reinforce the work of several bilateral subcabinet level dialogues on economic matters (including under the USTR-led TIFA) and to 

provide political-level guidance on particularly challenging commercial and economic issues.

Medical Devices – Reimbursement and Regulatory Requirements

The United States has raised concerns over Turkey’s 2010 medical device reimbursement 

regulation, Communiqué SUT 2010/16, which appears to add a duplicative regulatory burden 

requiring medical device producers to supply documentation to Turkey’s Social Security 

Institute. Turkey asserts the additional documentation is needed for quality assurance purposes. 

If a medical device producer fails to comply, the Turkish government can respond by canceling 

all payments from the public health sector reimbursement system to the device manufacturer. It 

is unclear how the additional documentation will help provide assurances with respect to the 

quality of medical devices considering that Turkey’s Ministry of Health, which oversees 

medical device safety and efficacy, does not require such documentation. In the March, June, 

and November 2011 TBT Committees meetings as well as in bilateral meetings, the United 

States urged Turkey to notify its new requirements to the WTO, to meet with industry 

stakeholders, and to eliminate or modify any documentation requirements that are not required 

to satisfy the requirements of Turkey’s Medical Device Directive. Turkey has not yet responded 

to these requests, and the United States will continue to engage with Turkey on this issue in 

2012. 

Pharmaceuticals – GMP Decree

The United States has raised several concerns about Turkey’s Ministry of Health “Regulation to 

Amend the Regulation on the Pricing of Medicinal Products for Human Use,” which took effect 

on March 1, 2010. The regulation requires foreign pharmaceutical producers, as a condition of 

exporting their products to Turkey, to secure a Good Manufacturing Practice (GMP) certificate 

before their products can be certified for sale in Turkey. GMP certification is contingent on a 

physical plant inspection by Turkish authorities.

The United States has expressed concerns that Turkey did not publish or notify the regulation to 

the WTO nor initially identify any health or safety issue arising from imports from the United 

States or other countries that prompted it to discontinue accepting GMP certificates issued by 

foreign regulatory authorities, such as the U.S. Food and Drug Administration. U.S. industry 

also raised concerns about Turkey’s inspection requirement, including the fact that numerous 

approvals are pending and Turkey may not have sufficient capacity to inspect all foreign 

manufacturing plants in a timely fashion. Given the apparent lack of inspection capacity, the 
91

United States is concerned that the process for obtaining approval could take several years, 

effectively shutting U.S. pharmaceutical exports out of Turkey. In the March, June, and 

November 2011 TBT Committee meetings as wells as in bilateral meetings, the United States 

raised concerns over the new inspection requirement. The United States will continue to press 

Turkey to address U.S. industry concerns in 2012.

Vietnam

Bilateral Engagement

The United States discusses standards-related issue with Vietnam during TBT Committee

meetings and on the margins of TPP negotiations, as well as through the bilateral U.S. –

Vietnam TIFA Council, which meets regularly and serves as a forum for promoting increased 

technical cooperation activities. The United States also works with Vietnam in advancing 

standards and conformity assessment issues through APEC.

Alcoholic Beverages – Food Safety Regulations for Alcohol

In March 2010, Vietnam notified to the WTO a proposed regulation aimed at ensuring that 

alcoholic beverages are safe to consume. The proposed regulation lays out management and 

technical requirements for the raw materials used in processing alcoholic beverages, including 

chemical and microbiological parameters, heavy metals, food additives, and labeling 

requirements. The proposed regulation would also require a compliance certification stamp and 

impose new inspection and testing requirements for products covered by the regulation.

In May 2010, the United States submitted comments to Vietnam, expressing concerns with

numerous aspects of the proposal, including the proposed maximum level for aldehydes in

distilled spirits of 5 mg per liter of pure alcohol. Standards of identity for spirits in most

international markets are based on raw materials and production processes, not the chemical

composition of the product. As such, these standards typically do not contain limits on

aldehydes. In its comments, the United States also raised concerns about other aspects of

Vietnam’s proposal and asked Vietnam for clarification on the compliance certification stamp 

requirement as well as the new inspection and testing requirements.

In response to U.S. concerns, Vietnam withdrew its proposed maximum level for aldehydes in

most distilled spirits in December 2010, and vodka in March 2011. Vietnam also helped to 

resolve U.S. concerns by providing clarifications sought by the United States, including in 

regard to the process for obtaining testing and inspection certifications.

Conformity Assessment Procedures – Alcohol, Cosmetics, and Mobile Phones 

During 2011, Vietnam issued a series of notices that appear to require new testing requirements 

on a diverse group of imported products, including spirits, cosmetics, and mobile phones. In 

addition, the notices appear to limit entry for covered goods to three sea ports and impose a 

consularization requirement (i.e., requiring Vietnam’s consulate in the country of export to 

approve all exports). The United States, along with a number of other trading partners have 

raised concerns with these measures directly with Vietnam and in the TBT Committee. 
92

While Vietnam provided clarifications to the United States on some aspects of the new 

requirements, a number of questions remain unanswered, including the extent to which the 

notices impose new or additional conformity assessment procedures for imported products and 

the extent to which domestic products are subject to similar requirements. The United States 

also continues to raise concerns regarding the limitation on ports of entry and the unnecessary 

costs and delays the consularization requirements will impose on U.S. exporters. The United 

States continues to urge Vietnam to notify the conformity assessment procedures associated 

with this measure to the TBT Committee and follow the relevant transparency procedures. 
93

XII. Appendix A: List of Commenters

Public comments received from:

1. Herbalife International of America, Inc.

2. National Electrical Manufacturers Association

3. Royal Thai Embassy

4. Yum! Restaurants International
94
95

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

ANSI .......................................................................... American National Standards Institute 

APA............................................................................ Administrative Procedure Act of 1946

APEC ......................................................................... Asia Pacific Economic Cooperation

EU .............................................................................. European Union

FSCF .......................................................................... Food Safety Cooperation Forum

FSCF PTIN ................................................................ Food Safety Cooperation Forum’s

.................................................................................... Partnership Training Institute Network

FTA............................................................................ Free Trade Agreement

GATT......................................................................... General Agreement on Tariffs and Trade

IAF ............................................................................. International Accreditation Forum

IEC.......................................................... International Electrotechnical Commission

ILAC ......................................................................... International Laboratory Accreditation

Cooperation

ISO ............................................................................. International Organization for

Standardization

MRA .......................................................................... Mutual Recognition Agreement

NAFTA ...................................................................... North American Free Trade Agreement

NAMA ....................................................................... Non-Agricultural Market Access

NEI............................................................................. National Export Initiative

NIST........................................................................... National Institute of Standards and

....................................................................................Technology 

NTTAA...................................................................... National Technology Transfer and 

.................................................................................... Advancement Act

NTB............................................................................ Non-Tariff Barrier

NTE............................................................................ National Trade Estimate Report on Foreign 

....................................................................................Trade Barriers

OECD......................................................................... Organization for Economic Cooperation 

....................................................................................and Development

OMB .......................................................................... Office of Management and Budget

SCSC ......................................................................... Subcommittee on Standards and 

.................................................................................... Conformance 

SDO............................................................................ Standards Developing Organization 

SME ........................................................................... Small and Medium Size Enterprise

SPS............................................................................. Sanitary and Phytosanitary Measures

TAA ........................................................................... Trade Agreements Act of 1979

TBT............................................................................ Technical Barriers to Trade

TEC............................................................................ United States – European Union 

.................................................................................... Transatlantic Economic Council

TFTF .......................................................................... Trade Facilitation Task Force

TIFA........................................................................... Trade and Investment Framework 

....................................................................................Agreement

TPP............................................................................. Trans-Pacific Partnership 

TPSC.......................................................................... Trade Policy Staff Committee

USDA......................................................................... U.S. Department of Agriculture
96

USITC........................................................................ U.S. International Trade Commission

USTR .........................................................................Office of the United States Trade 

Representative

WTO .......................................................................... World Trade Organization