2014 REPORT ON 

TECHNICAL BARRIERS 

TO TRADE

UNITED STATES TRADE REPRESENTATIVE

ACKNOWLEDGEMENTS

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

this report. U.S. Trade Representative Michael Froman 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 U.S. 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, and the 

Office of Management and Budget, as well as to the U.S. International Trade Commission.

In preparing the report, substantial information was solicited from U.S. embassies and from 

interested stakeholders. 

April 2014
iii

Table of Contents

I. Forward....................................................................................................................................................................... 4

II. Executive Summary .................................................................................................................................................. 6

III. Introduction ............................................................................................................................................................. 8

Genesis of this Report.................................................................................................................................................. 8

Central Focus in 2013.................................................................................................................................................. 9

Overview of Standards Related Measures................................................................................................................... 9

IV. Overview of Trade Obligations on Standards Related Measures ..................................................................... 12

Operation of the TBT Agreement.............................................................................................................................. 16

Standards-Related Provisions in U.S. Free Trade Agreements.................................................................................. 18

V. U.S. Statutory and Administrative Framework for Implementing Standards Related Obligations .............. 21

VI. Standards ............................................................................................................................................................... 25

VII. Conformity Assessment Procedures .................................................................................................................. 28

VIII. U.S. Processes for Identifying Standards-Related Trade Barriers and How to Address Them ................. 31

Engagement in Voluntary Standards ......................................................................................................................... 34

IX. U.S. Engagement on Standards-Related Measures in International, Regional and Bilateral Fora .............. 36

Overview of U.S. Engagement on Standards-Related Measures............................................................................... 36

WTO TBT Committee and Related Engagement ...................................................................................................... 37

Specific Trade Concerns....................................................................................................................................... 37

Systemic Issues..................................................................................................................................................... 38

Technical Assistance and Capacity Building............................................................................................................. 38

Standards Alliance ................................................................................................................................................ 38

Total Economic Engagement Program.................................................................................................................. 39

Commercial Law Development Program.............................................................................................................. 40

Association of Southeast Asian Nations.................................................................................................................... 40

Asia Pacific Economic Cooperation .......................................................................................................................... 41

Electric Vehicle Standards.................................................................................................................................... 41

Good Regulatory Practice ..................................................................................................................................... 42

Green Buildings .................................................................................................................................................... 42

Wine Regulatory Forum........................................................................................................................................ 43

ICT Energy Efficiency .......................................................................................................................................... 44

Trans-Pacific Partnership........................................................................................................................................... 44
iii

Trans-Atlantic Trade and Investment Partnership ..................................................................................................... 45

Free Trade Agreement – TBT Chapter Meetings ...................................................................................................... 47

Regulatory Cooperation Fora..................................................................................................................................... 48

Executive Order 13609 ......................................................................................................................................... 48

European Union .................................................................................................................................................... 48

Mexico .................................................................................................................................................................. 48

Canada................................................................................................................................................................... 49

North American Leaders Summit ......................................................................................................................... 49

X. Country Reports...................................................................................................................................................... 51

Argentina ................................................................................................................................................................... 51

Brazil ......................................................................................................................................................................... 52

Chile .......................................................................................................................................................................... 54

China.......................................................................................................................................................................... 56

Colombia ................................................................................................................................................................... 63

Ecuador...................................................................................................................................................................... 65

European Union......................................................................................................................................................... 66

India........................................................................................................................................................................... 78

Indonesia.................................................................................................................................................................... 82

Korea ......................................................................................................................................................................... 83

Malaysia..................................................................................................................................................................... 86

Mexico....................................................................................................................................................................... 87

Peru............................................................................................................................................................................ 90

Russia Federation....................................................................................................................................................... 92

Saudi Arabia .............................................................................................................................................................. 96

Taiwan ....................................................................................................................................................................... 97

Turkey........................................................................................................................................................................ 99

Appendix A: List of Commenters............................................................................................................................. 102

Appendix A: List of Frequently Used Abbreviations and Acronyms.................................................................... 103
4

I. FOREWORD

This year the USTR publishes its fifth 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 nontariff 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, some standards-related measures 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, such 

as protection of the environment, human health and safety. 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.

Since the last TBT Report was released, the United States has significantly advanced its efforts 

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

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

standards-related trade concerns through new and existing cooperative initiatives in the World 

Trade Organization (WTO), Asia Pacific Economic Cooperation Forum (APEC), U.S. free 

trade agreements (FTAs), and other fora. In addition USTR will continue working to conclude 

on the negotiation of a modernized Technical Barriers to Trade (TBT) chapter in the TransPacific Partnership (TPP) that builds on and strengthens TBT disciplines contained in the 

WTO Agreement on Technical Barriers to Trade (TBT Agreement). In addition, in June 2013, 

President Obama and European Union (EU) leaders launched negotiations on a comprehensive 

trade and investment agreement, the Transatlantic Trade and Investment Partnership (T-TIP). 

As conveyed in the February 2013 United States-European Union High Level Working Group 

on Jobs and Growth (HLWG) Final Report, the United States and the EU are committed to 

working together to open markets in goods, services and investment, reduce nontariff barriers, 

and address global trade issues of common concern. Both parties seek to build on the 

horizontal disciplines of the WTO TBT Agreement, establish ongoing mechanisms for 

improved dialogue and cooperation for addressing bilateral technical barriers to trade (TBT)

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

reducing unnecessary costs stemming from regulatory differences in specific sectors.

Again in 2014, 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 
5

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 Michael Froman

U.S. Trade Representative 

April 2014
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II. EXECUTIVE SUMMARY

The 2014 TBT Report is a specialized report focused on significant foreign trade barriers in the 

form of product standards, technical regulations and testing, certification, and other procedures 

involved in determining whether products conform to standards and technical regulations and 

actions the United States is taking to address these barriers. These standards-related trade 

measures, which in World Trade Organization (WTO) terminology are known as “technical 

barriers to trade” (TBT), play a critical role in shaping the flow of global trade.

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

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

foreign markets. Standards-related measures also enable governments to pursue legitimate 

objectives such as protecting human health and the environment and preventing deceptive 

practices. But standards-related measures that are nontransparent, discriminatory, or 

otherwise unwarranted can act as significant barriers to U.S. trade. Such measures can pose a 

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

on their own.

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

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

components:

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

the growing importance of standards-related measures in international trade (Section III);1

• 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 

 1

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

hyperlinks to additional information are provided throughout the report. To access official documents of the 

WTO (such as those identified by the document symbol “G/TBT/...”) go to

https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S005.aspx and click on “search” and enter the document 

symbol.
7

of conformity assessment and the possibility for international systems of conformity 

assessment to facilitate trade (Section VII);

• 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 creation of new barriers through 

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

Barriers to Trade (WTO TBT Committee) and cooperative activities under the Asia Pacific 

Economic Cooperation Forum (APEC) Subcommittee on Standards and Conformance, among 

others (Section IX);

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

currently facing U.S. exporters, along with U.S. Government initiatives to eliminate or reduce 

the impact of these barriers (Section XI) in 16 countries – Argentina, Brazil, China, Chile, 

Colombia, Ecuador, India, Indonesia, Korea, Malaysia, Mexico, Peru, Russia, Saudi Arabia, 

Taiwan, and Turkey – as well as the European Union (EU).
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III. INTRODUCTION

Genesis of this Report

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

the effective implementation and enforcement of the WTO’s system of multilateral trade rules. The 

President vowed to pursue an aggressive and transparent program of defending U.S. rights and 

benefits under the rules-based trading system as a key element in his vision to restore trade’s role in 

leading economic growth and promoting higher living standards. The President has also recognized 

that nontariff barriers have grown in significance for U.S. exporters seeking access to foreign 

markets. Two kinds of nontariff measures pose a particular challenge to U.S. exports: sanitary and 

phytosanitary (SPS) measures and standards-related measures.

Accordingly, in 2009 USTR created a new SPS Report and a TBT Report. These reports are 

intended to promote understanding of the process of identifying nontariff measures in the form of 

SPS and standards-related 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 these nontariff 

barriers; and to document the actions underway to give greater transparency and confidence to 

American workers, producers, businesses, and other stakeholders regarding the actions this 

Administration is taking on their behalf.

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

standards, technical regulations, and conformity assessment procedures (standards- related 

measures). Prior to 2010, the National Trade Estimate Report on Foreign Trade Barriers (NTE 

Report) addressed standards-related measures.2

 By addressing significant foreign trade barriers in 

the form of standards-related measures, the TBT Report meets the requirements under Section 181 

of the Trade Act of 1974, as amended, to report on significant foreign trade barriers with respect to 

standards-related measures. A separate report addressing significant foreign trade barriers in the 

form of SPS measures (2014 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 

 2

 In accordance with section 181 of the Trade Act of 1974 (the 1974 Trade Act) (codified at 19 U.S.C. § 2241), as 

amended by section 303 of the Trade and Tariff Act of 1984 (the 1984 Trade Act), section 1304 of the Omnibus Trade 

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

(1994 Trade Act), and section 1202 of the Internet Tax Freedom Act, the Office of the U.S. Trade Representative is 

required to submit to the President, the Senate Finance Committee, and appropriate committees in the House of 

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

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

protection of intellectual property rights.
9

imposed or under consideration by certain U.S. trading partners. The report also includes general 

information on standards-related measures, the processes and procedures the United States uses to 

implement these measures domestically, and the tools the United States uses to address standardsrelated measures when they act as unnecessary barriers to trade. This general information is 

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

sections of the report, as well as the channels for resolving them. These last section reviews identify

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

businesses, along with U.S. Government initiatives to eliminate or reduce these barriers.

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

comments that USTR solicited through a notice published in the Federal Register, reports from 

U.S. embassies abroad and from other Federal agencies, and USTR’s ongoing consultations with 

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

commenters that submitted comments in response to the Federal Register notice.

Central Focus in 2013

During 2013, the United States succeeded in persuading its trading partners to reduce or eliminate a 

variety of unwarranted standards-related barriers to trade identified in last year’s report. The United 

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

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

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

good regulatory practices. In 2013, to encourage governments to eliminate and prevent

unwarranted standards-related barriers to trade, the United States proposed new initiatives in key 

trade and economic forums, including in the WTO and the Asia Pacific Economic Cooperation 

Forum (APEC); launched negotiations for the Transatlantic Trade and Investment Partnership (TTIP); and sought to conclude a Trans-Pacific Partnership (TPP) agreement.

Overview of Standards-Related Measures

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

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

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

shaping international trade has declined due in large part to successful rounds of multilateral tariff 

reductions in the WTO and its predecessor, the General Agreement on Tariffs and Trade (GATT 

1947). With tariff reductions, the role of nontariff barriers in international trade has become more 

prominent.

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

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

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

• ensure the connectivity and compatibility of inputs sourced in different markets;
10

• 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;

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

preventing deceptive practices, and protecting the environment; and

• promote more environmentally sound or socially conscious production methods. 

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

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

and end products they purchase from a wide variety of suppliers. These measures also enable more 

widespread access to technical innovations. Standards-related measures can offer particularly 

pronounced benefits to SMEs from this perspective. Uniform standards and product testing 

procedures established under a common set of technical requirements that producers can rely on in 

manufacturing components and end products, can facilitate the diffusion of technology and 

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

global supply chains.

Conversely, outdated, overly burdensome, discriminatory, or otherwise inappropriate standardsrelated measures can reduce competition, stifle innovation, and create unnecessary obstacles to 

trade. Even when standards-related measures are used appropriately, firms – particularly SMEs –

can face significant challenges in accessing information about, and complying with, diverse and 

evolving technical requirements in major export markets. This is particularly the case when 

technical requirements change rapidly or differ markedly across markets.

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

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

stakeholders must also confront an important question: how to ensure that standards-related 

measures facilitate innovation, competition, consumer and environmental protection, and other 

public policy objectives, without creating unnecessary obstacles to trade? As supply chains grow 

increasingly complex, governments and other stakeholders must also address the question of how to 

better align standards and technical requirements across jurisdictions and markets as a means to 

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

standards and technical regulations across jurisdictions and markets, and enhance governments’ 

ability to achieve important public policy objectives.

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

trade agreements establish serve as an important foundation for addressing many of these questions. 

The TBT Agreement is the principal agreement establishing multilateral rules governing standardsrelated measures. (Box 1 lays out definitions provided under the TBT Agreement for standardsrelated measures.) U.S. FTAs establish additional rules with respect to these measures with specific 
11

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).

3

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

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

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

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

APEC and the Organization for Economic Cooperation and Development (OECD). USTR also 

raises standards-related issues in bilateral dialogues with U.S. trading partners. These efforts are 

designed to ensure that U.S. trading partners adhere to internationally agreed rules governing these 

measures and to reduce or eliminate unnecessary measures of this kind that can create barriers for 

U.S. producers and businesses.

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

Technical regulation

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

administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, 

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

Standard

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

products or related processes and production methods, with which compliance is not mandatory. It may also include or deal 

exclusively with terminology, symbols, packaging, marking, or labeling requirements as they apply to a product, process, or 

production method.

Conformity assessment procedures

Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.

Explanatory note: Conformity assessment procedures include, inter alia, procedures for sampling, testing and inspection; evaluation, 

verification and assurance of conformity; registration, accreditation, and approval as well as their combinations.

Source: Annex 1 of the TBT Agreement

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

 3

http://www.ustr.gov/about-us/executive-branch-agencies-trade-policy-staff-committee-and-trade-policy-review-group
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IV. OVERVIEW OF TRADE OBLIGATIONS ON

STANDARDS-RELATED MEASURES

WTO Agreement on Technical Barriers to Trade

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

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

unnecessary obstacles to trade.4

 The TBT Agreement establishes rules on developing, adopting, and 

applying voluntary product standards and mandatory technical regulations as well as conformity 

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

product meets such standards or regulations. These rules help distinguish legitimate 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 prepare, adopt, and apply 

standards-related measures necessary to protect human health, safety and the environment at the 

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

TBT Agreement imposes obligations regarding the development and application of those measures. 

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

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

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

against imported products or create unnecessary obstacles to trade. The TBT Agreement contains a 

Code of Good Practice for the Preparation, Adoption, and Application of Standards (Code). The 

Code applies to the preparation, adoption, and application of voluntary standards and is open to 

acceptance by any standardizing body located in the territory of any WTO Member, including 

government and non-governmental bodies. (Box 2 outlines the key disciplines of the TBT 

Agreement.)

Box 2. Key principles and provisions of the TBT Agreement

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

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

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

to ensure that “conformity assessment procedures are prepared, adopted and applied so as to grant access for suppliers 

of like products originating in the territories of other Members under conditions no less favorable than those accorded 

to suppliers of like products of national origin or originating in any other country, in a comparable situation.” (Art. 

5.1.1) The Agreement also requires that Members ensure that related fees are equitable (Art. 5.2.5) and that they 

respect the confidentiality of information about the results of conformity assessment procedures for imported 

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

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

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

 4

http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm
13

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

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

requirements. (Art. 5.1.2)

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

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

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

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

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

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

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

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

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

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

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

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

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

Acceptance of technical regulations as equivalent: Alongside promoting better alignment of technical regulations, 

the Agreement encourages Members to accept technical regulations that other Members adopt as “equivalent” to their 

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

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

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

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

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

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

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

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

recognition of each other’s conformity assessment results (i.e., mutual recognition agreements (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 WTO TBT Committee has recommended be “at least 

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

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

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

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

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

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

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

interested parties and to provide documents relating to technical regulations, standards, and conformity assessment 

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

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

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

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

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

Enforcement and dispute settlement: The Agreement establishes the TBT Committee as the major forum for WTO 

Members to consult on matters relating to the operation of the Agreement, including specific trade concerns about 
14

measures that Members have proposed or adopted. (Art. 13) The TBT Agreement provides for disputes under the 

Agreement to be resolved under the auspices of the WTO Dispute Settlement Body and in accordance with the terms 

of the WTO’s Dispute Settlement Understanding. (Art. 14)

Other: As noted above, the Agreement sets out a Code for preparing, adopting, and applying voluntary standards. 

(Annex 3) Standardizing bodies that Members establish at the central level of government must comply with the 

Code, and Members must take reasonable measures to ensure that local government and private sector standardizing 

bodies within their territories also accept and comply with the Code. (Art. 4.1) The Code is open to acceptance by 

any standardizing body in the territory of a WTO Member, including private sector bodies as well as public sector 

bodies. The Code requires Members and other standardizing bodies that have accepted it to adhere to obligations 

similar to those for technical regulations, for example, to ensure that the standards they adopt do not create 

unnecessary obstacles to trade and are based on relevant international standards, except where ineffective or 

inappropriate.

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

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

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

Committee reports and recommendations.

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

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

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

The TBT Agreement, therefore, requires every WTO Member to establish a national inquiry point 

that is able to answer reasonable questions from other Members and interested parties concerning 

the Member’s proposed or existing measures and provides relevant documents, as appropriate. It 

also requires each WTO Member to ensure that all standards- related measures that it adopts are 

promptly published or otherwise made publicly available.

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

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

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

 In particular, the TBT 

Agreement requires each Member to publish a notice in advance that it proposes to adopt a technical 

regulation or conformity assessment procedure.6

 It also requires each WTO Member to notify 

proposed technical regulations and conformity assessment procedures to the WTO so that other 

WTO Members may comment on them in writing. WTO Members are required, without 

discrimination, to take into account these written comments, plus the results of any requested, 

discussions of those comments, when finalizing the measures.7

 5

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

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

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

6

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

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

publishing the full text of the draft measure.

7

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

on relevant international standards, guides, or recommendations or in circumstances where relevant international 
15

In 2013 alone, WTO Members notified 1,626 new or revised technical regulations and conformity 

assessment procedures, as well as submitted 467 addenda and 42 corrigenda to previous 

notifications. Since entry into force of the Marrakesh Agreement Establishing the World Trade 

Organization (WTO Agreement)8on January 1, 1995, up to December 31, 2013, 17,418

notifications along with 3,150 addenda and 524 corrigenda to these notifications have been made by 

121 Members. Box 3 shows the number of notifications yearly since 1995.9

Box 3. Number of TBT Notifications since 1995

10

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 WTO TBT Committee is 

open to participation by all 159 WTO Members. The WTO TBT Committee is one of over a dozen 

 

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.

8

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

9

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

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

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

Members also notify adopted technical regulations and conformity assessment procedures (regardless of whether or not 

they are based on relevant international standards).

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

of the TBT Agreement (G/TBT/33).”

650 674 608 547 587

797

640 764 876

1035

1263

1492 1432

1230

1571 1626

22

40

46

31 23 25 27 38

100

84

130

155

188

259

397 435

541

624 509

386

501

845

681 697 633 574 625

897

724

894

1031

1223

1522

18891867

1771

21952135

0

500

1000

1500

2000

2500

Notifications Addenda/Corrigenda
16

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 WTO TBT Committee are described in detail below.

Operation of the TBT Agreement

The TBT Agreement sets out rules covering standards-related measures developed and 

implemented by disparate bodies (central and local governmental agencies; inter-governmental 

entities; and non-governmental, national, and international standardizing organizations). WTO 

Members’ central government authorities have primary responsibility for ensuring compliance with 

the TBT Agreement, including by taking reasonable measures to ensure that local and nongovernmental bodies, such as private sector standards developing organizations, comply with the 

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

laws, policies, and procedures it has adopted to implement and administer the TBT Agreement.11

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

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

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

Agreement requires. Sound mechanisms for internal coordination among a WTO Member’s trade, 

regulatory, and standards officials are critical to ensuring that the Member effectively implements 

the TBT Agreement. When interested agencies and officials coordinate their efforts in developing 

standards-related measures, it makes it more likely that the government will consider alternative 

technical specifications that may reduce any adverse effects on trade while still fulfilling the 

measure’s objective.

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

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

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

extent to which it is able to resolve specific trade concerns raised by other Members. Accordingly, 

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

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

assistance or cooperative efforts to improve internal coordination can be vital in helping U.S. 

exporters sell into these markets.

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

policies and procedures for implementing specific obligations.12

 In the course of these reviews, 

Members adopt specific recommendations and decisions, and lay out a forward looking work 

program to strengthen the implementation and operation of the TBT Agreement. To advance their 

understanding of systemic issues, Members share experiences and participate in special events and 

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

administer the TBT Agreement.

12 The Committee’s work on the outcome of the most recent triennial review is discussed in Section IX of this report.
17

regional workshops to explore topics in depth. In recent years, WTO TBT 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 WTO TBT 

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

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

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

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

perhaps even help to resolve the concerns. In 2013, WTO Members raised over 73 specific trade 

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

relating to managing hazards arising from use of chemicals, labeling and other nonsafety 

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

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

importance of the WTO TBT Committee’s regular discussions of specific trade concerns, and 

agreed that the WTO TBT Committee’s work has helped to clarify and resolve trade issues between 

WTO Members.13

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

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

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

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

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

discussions in the WTO 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.

 13 See the discussion of the Operation of the Committee in the Fifth Triennial Review of the Operation and 

Implementation of the Agreement on Technical Barriers to Trade under Article 15.4, G/TBT/26.
18

Box 4. Number of specific trade concerns

14

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

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

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

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

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

systemic issues needed to prevent and resolve trade issues. In 2012, the WTO TBT Committee 

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

sharpen focus and make progress on key systemic issues. In 2013, the WTO TBT Committee held 

thematic discussions on standards and good regulatory practices on March 5; on good regulatory 

practices and inquiry point operations on June 19; and on conformity assessment procedures, 

special and differential treatment, and technical assistance on October 29.

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

In U.S. FTAs, the parties reaffirm their commitment to the TBT Agreement. U.S. FTAs build on 

the disciplines in the TBT Agreement in important ways, including by providing for greater 

transparency, establishing mechanisms for more in depth consultation on specific trade concerns, 

 14 Number of specific trade concerns raised since 1995, found in “Nineteenth Annual Review of the Implementation and 

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

3 6 4 7 12 12 13 12 12

19

26 28 32 32

59

31

4 6 11

13 5 13

15

20 15 14 12

24

27

32

46

29

43

35

42

4 6

11

16

11

17

22

32

27 27 24

36

46

58

74

61

75

94

73

0

10

20

30

40

50

60

70

80

90

100

Previous Concerns New Concerns
19

and facilitating cooperation and coordination with FTA partners on systemic issues. As a result, the 

U.S. approach to standards-related measures in its FTAs is commonly referred to as “TBT plus.”15 

For example, recent FTAs require each party to allow persons of the other party to participate in the 

development of standards, technical regulations and conformity assessment procedures. Moreover, 

each party is required to permit persons of the other party to participate in the development of these 

measures on terms no less favorable than it accords its own persons.

U.S. FTAs also contain a variety of other substantive obligations that go beyond those in the TBT 

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

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

testing and certification bodies. Recent U.S. FTAs, as well as the earlier North American Free 

Trade Agreement (NAFTA), also build in mechanisms (such as special committees) for closer and 

more enduring engagement and cooperation on standards-related measures. These mechanisms can 

prevent specific trade concerns from arising and assist the FTA governments in resolving emerging 

problems.

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

conformance processes, these consultative mechanisms can enable early identification of potential 

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

before a measure is finalized.16 The provisions in U.S. FTAs that provide for more timely and 

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

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

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

FTA partners whose standards and conformance processes may be underdeveloped or otherwise in 

need of improvement.

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

negative effects on their bilateral trade stemming from unnecessary differences in their regulatory 

regimes. Several U.S. FTAs also contain provisions designed to encourage FTA partners to accept 

each other’s regulations as equivalent to their own, where appropriate.

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

a framework for developing voluntary product standards – by formally recognizing the WTO TBT 

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

17

 The 

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

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

Converge towards the Multilateral Trading System? (OECD (TAD/TC/WP (2007)12/FINAL).

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

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

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

to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.11.
20

U.S. experience with the 2000 Committee Decision is described at length in G/TBT/W/305. (These 

issues are discussed in more detail in Section VI below.)

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

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

FTAs share common provisions relating to standards-related measures. This box summarizes standards-related 

provisions common to U.S. FTAs with Australia, Bahrain, Central America and the Dominican Republic, Chile, 

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

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

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

procedures.

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

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

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

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

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

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

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

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

assessment body.

Transparency: The FTAs expand upon transparency obligations provided for in the TBT Agreement. For example, US 

FTAs with Colombia, Peru and Korea provide that each party shall permit persons from the other party to participate in 

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

require parties (1) to notify proposed technical regulations even where those regulations are based on relevant 

international standards; (2) to notify proposals for technical regulations or conformity assessment procedures directly to 

the other party; (3) to include in notifications of proposed technical regulations and conformity assessment procedures 

the objectives of the proposed measure and the proposed measure’s rationale or how the measure meets those 

objectives; (4) to provide interested parties as well as the FTA partner a meaningful opportunity to comment on the 

proposed measure; (5) to allow at least 60 days for comment; (6) to provide responses to significant comments received 

no later than the time a final measure is published; and (7) to provide additional information about the objectives when 

requested.

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

conformity assessment procedures. They also urge parties to identify bilateral initiatives for specific issues or sectors.

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

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

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

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

pertinent developments.

Note: For more information, see http://www.ustr.gov/trade-agreements/free-trade-agreements.
21

V. U.S. STATUTORY AND ADMINISTRATIVE

FRAMEWORK FOR IMPLEMENTING

STANDARDS-RELATED TRADE

OBLIGATIONS

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

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

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

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

FTAs includes the Administrative Procedure Act of 1946 (APA) and the Trade Agreements Act of 

1979 (TAA).18 The APA establishes a process of public participation in rulemakings by U.S. 

agencies through a system of notice and comment. The TAA prohibits Federal agencies from 

engaging in any standards-related activity that creates unnecessary obstacles to trade and directs 

them to consider the use of international standards in rulemaking.

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

developing international trade policy regarding standards-related activities, as well as in discussions 

and negotiations with foreign governments on standards-related matters. In carrying out this 

responsibility, USTR is required to inform and consult with Federal agencies having expertise in the 

matters under discussion and negotiation. The TAA also directs the U.S. 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 rulemakings, and to take these comments into

account in the final rule.19 In accordance with the APA, agencies publish proposed technical 

regulations and conformity assessment procedures in the Federal Register and solicit comments 

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

Technical Barriers to Trade (Standards). 

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

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

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

regarding technical regulations and conformity assessment procedures. The APA makes exceptions for urgent matters, 

allowing Federal agencies to omit notice and comment, for example, where they find that notice and public procedures 

are impracticable or contrary to the public interest. 5 U.S.C. § 553(b)(3).
22

from the public through notices published in the Federal Register. To fulfill WTO obligations to 

notify proposed technical regulations and conformity assessment procedures, the National Institute 

of Standards and Technology (NIST) in the U.S. Department of Commerce serves as the U.S. 

notification authority and inquiry point for purposes of the TBT Agreement. The U.S. inquiry point 

reviews the Federal Register and other materials on a daily basis and notifies the WTO of technical 

regulations and conformity assessment procedures that agencies propose to adopt.

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

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

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

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

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

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

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

key TBT Agreement and U.S. FTA obligations. GRP,20 such as that embodied in E.O. 12866 and 

Circular A-4, enables government agencies to achieve their public policy objectives efficiently and 

effectively. GRP is also critical in reducing the possibility that governments will adopt standardsrelated measures that create unnecessary obstacles to trade.

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

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

Significant regulatory actions are defined to include any regulatory action that is likely to result 

in a rule that may:

1. have an annual impact on the U.S. economy of $100 million or more or adversely 

affect in a material way the economy, a sector of the economy, productivity, 

competition, jobs, the environment, public health or safety, or sub-federal 

governments;

2. create a serious inconsistency or otherwise interfere with an action taken or planned 

by another agency;

3. materially alter the budget impact of entitlements, grants, user fees or loan programs 

or the rights and obligations of their recipients; or

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

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

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

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

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

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

OECD and APEC, APEC-OECD Integrated Checklist on Regulatory Reform. Mexico City, 2005.
23

4. raise novel legal or policy issues.

For those significant rules that are determined by OMB to fall within the first category, OMB 

requires the agency to also provide an assessment of the benefits and costs of the regulation, 

including with respect to the efficient function of the economy and private markets, health and 

safety, the environment, and other alternatives that are potentially effective and reasonably feasible. 

OMB also reviews Federal agencies’ proposed regulatory actions and consults with USTR and 

other agencies as needed. This review is designed to ensure, inter alia, that proposed regulatory 

actions are not duplicative or inconsistent with other planned or existing Federal regulatory actions, 

are consistent with U.S. international trade obligations, and take into account the trade impact of 

proposed regulatory actions. At the conclusion of this process, OMB provides guidance to the 

pertinent agency to ensure that its regulatory actions are consistent with applicable law, Presidential 

priorities, and E.O. 12866’s regulatory principles.

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

Regulatory Review (E.O. 13563), which reaffirms and supplements E.O. 12866. E.O. 13563 states 

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

while promoting economic growth, innovation, competitiveness, and job creation. It must allow for 

public participation and an open exchange of ideas. It must promote predictability and reduce 

uncertainty. It must identify and use the best, most innovative and least burdensome tools for 

achieving regulatory ends. It must take into account benefits and costs, both quantitative and 

qualitative.” E.O. 13563 sets out certain regulatory principles, as well as new requirements 

designed to promote public participation, improve regulatory integration and innovation, increase 

flexibility, ensure scientific integrity, and increase retrospective analysis of existing rules.

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

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

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

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

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

Advancement Act (NTTAA) and OMB’s implementing guidance to Federal agencies, Circular No. 

A-119 requires Federal agencies to use

21 voluntary consensus standards22 in their regulatory 

activities wherever possible and to avoid using “government-unique” standards.23 The purpose is to 

discourage Federal agencies from developing their own standards where suitable voluntary 

consensus standards already exist. On February 11, 2014, OMB published a proposal to update A119, and is currently seeking comments from the public on proposed revision to the Circular. The 

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

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

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

23 Circular A-119 defines “government-unique standards” as standards developed by the government for its own uses.
24

proposal seeks to take account of the experience Federal agencies have gained since 1998, when 

Circular A-119 was originally issued. Among the proposed revisions are requirements for Federal 

agencies to ensure that standards in regulation are updated on a timely basis, to work with one 

another to reference the same version of a standard in regulation and procurements, and to increase 

public participation by having agencies alert the public when they are considering participation in 

standards development activities. These proposed changes, and others, will help guide agencies in 

preventing the creation of new trade barriers and avoid unnecessary regulatory differences with 

trading partners.

Voluntary consensus standards can often effectively achieve an agency’s regulatory objectives. The 

NTTAA and the TAA are complementary: the NTTAA directs Federal agencies to look to 

voluntary consensus standards to meet their regulatory objectives, while the TAA directs them to 

consider using relevant international standards. (As elaborated in Section VI, international 

standards are those that recognized bodies, either intergovernmental or non-governmental, develop 

in accordance with principles such as openness, transparency, and consensus.)

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

United States implements the TBT Agreement, see G/TBT/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 HLRCF of the United States – European Union Transatlantic Economic Council (TEC) i 

October 2009. For additional information on the relationship between technical barriers to trade 

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

Practice in Reducing Technical Barriers to Trade. In 2012, APEC published two related studies. 

The first study, Good Regulatory Practices in APEC Member Economies - Baseline Study reviews 

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

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

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

the TBT Agreement with Good Regulatory Practices, explores the relationship between TBT 

obligations and current GRPs used around the world. These recommended GRPs demonstrate 

choices available to WTO Members for implementation of practices that support trade-friendly 

regulation and implementation of their WTO commitments.
25

VI. STANDARDS

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

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

Agreement defines “standard” as: a document approved by a recognized body that provides, for 

common and repeated use, rules, guidelines or characteristics for products or related processes and 

production methods for which compliance is not mandatory.

Voluntary standards can facilitate buyer-seller transactions, spur competition24 and innovation, 

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

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

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

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

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

products and complex processes resides.25

The TBT Agreement seeks to minimize unnecessary obstacles to trade that can arise, for example, 

from specifications that favor domestic goods over imported ones, lack of transparency in the 

development of standards, 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 does not, however, designate specific standardizing bodies as “international.” 

Instead, in the 2000 Committee Decision, the WTO TBT Committee adopted a set of six principles

for developing international standards.26

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

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

Effective Collaboration, International Trade Administration, 2005, available at 

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

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

for the development of voluntary standards on the quality and identity of agricultural products sold in the U.S. market.

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

to Articles 2, 5 and Annex 3 of the TBT Agreement are contained in document G/TBT/1/Rev.10.
26

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

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

standards developed in conformity with the 2000 Committee Decision principles.27 For example, 

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

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

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

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

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

openness, and transparency when developing standards helps ensure standards are globally relevant 

and respond to both technical and regulatory needs. The 2000 Committee Decision also helps 

ensure that all interested parties, including producers and consumers that may be affected by a 

particular standard, can participate in developing it.

Annex 3 of the TBT Agreement contains a Code for WTO Members and non- governmental 

standardizing bodies to follow in preparing, adopting, and applying standards. Central government 

standardizing bodies must adhere to the Code.28 WTO Members’ central government 

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

reasonable measures to ensure that local government bodies and non- governmental standardizing 

bodies conform to the Code as well. In the United States, the American National Standards Institute 

(ANSI) has accepted the Code on behalf of the over 200 standards developing organizations (SDOs) 

that ANSI has accredited. ANSI, a private sector body, is the coordinator of the U.S. voluntary 

standards system with a membership that consists of standards developers, certification bodies, 

industry, government, and other stakeholders. In coordination with its membership, ANSI 

developed and implements the U.S. Standards Strategy.

29 (For more information on the ANSI 

system, see Overview of the U.S. Standardization System.)

ANSI accredits SDOs based on its Essential Requirements. These requirements largely 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 

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

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

29 Available at http://www.ansi.org/standards_activities/nss/usss.aspx
27

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

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

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

consensus standards bodies. The Interagency Committee for Standards Policy, which NIST chairs, 

coordinates implementation of this guidance. More than 4,000 Federal agency officials participate 

in the private sector standards development activities of 497 organizations31 to support regulatory 

needs, enable efficient procurement, and to help devise solutions to support emerging national 

priorities. It is notable, however, that governments in some regions and countries take a 

nontechnical and more commanding role in standards setting than Federal agencies generally do. 

For example, some governments direct their national standards bodies or central government bodies 

to develop voluntary standards to achieve specific regulatory needs.

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

31 Source: NIST, 2008.
28

VII. CONFORMITY ASSESSMENT

PROCEDURES

The TBT Agreement defines “conformity assessment procedures”32 as: “Any procedure used, 

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

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

a broader set of procedures, for example, good manufacturing practices that are not related to 

product characteristics.

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

products sourced in domestic and foreign markets meet specific requirements. 

Governments may mandate conformity assessment procedures – such as testing, sampling, and 

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

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

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

processes or systems meet particular specifications.33

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

assessment requirements are frequently cited as a key concern for U.S. exporters.34 Indeed, many 

specific trade concerns that the United States has raised in the WTO 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). 

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

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

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

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

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

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

or requirements.

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

Assessment System, NIST, 1997

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

U.S. International Trade Commission Working Paper, 2008
29

The WTO TBT Committee’s list of approaches that facilitate this acceptance is contained in

G/TBT/1/Rev.11.

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

Federal, State, and local entities with private sector technical standards activities and conformity 

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

Pursuant to this statutory directive, NIST published a notice in the Federal Register in 2000 

providing Guidance to Federal Agencies on Conformity Assessment.

35 This notice calls for Federal 

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

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

conformity assessment procedures in their regulations and procurement processes. The conformity 

assessment standards and guides published by ISO and IEC are known as the “CASCO toolbox, 

which are the international standards and guides agencies are encouraged to use.”36

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

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

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

37 OMB’s 

proposal to update Circular A-119 also contains guidance to Federal agencies with respect to 

conformity assessment. The TBT Agreement, NIST’s guidance, ANSI’s principles, and OMB’s 

proposal to update Circular A-119 all emphasize the importance of the development and use of 

international conformity assessment standards and participation in international accreditation 

systems in facilitating international trade.

Participation and use of international systems of conformity assessment strengthens these 

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

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

convenient to production facilities and reducing duplicative testing and certification requirements. 

International systems for accreditation enable this by establishing procedures and criteria that 

accreditation bodies participating in the system agree to apply when accrediting testing, 

certification, or other conformity assessment bodies. Accreditations issued by such entities can, in 

appropriate circumstances, provide governments, as well as suppliers, assurances that a body –

regardless of its location – is competent to test and certify products for relevant markets.

Examples of international accreditation systems include the International Laboratory Accreditation 

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

established voluntary MRAs. Under these MRAs, accreditation bodies agree to adhere to 

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

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

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

pdf
30

international standards and other procedures and criteria when accrediting testing and certification 

bodies and subject themselves to a system of peer to peer review to ensure that they continue to 

meet MRA requirements. Accreditation bodies that participate in these mutual recognition 

arrangements are predominately private sector entities in the United States. 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.
31

VIII. U.S. PROCESSES FOR IDENTIFYING

STANDARDS-RELATED TRADE

BARRIERSAND 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 agencies and other agencies 

with an interest in foreign standards-related measures, meets formally at least three times a year, but 

maintains an ongoing process of informal consultation and coordination on standards-related issues 

as they arise. Representatives of the TPSC Subcommittee include officials from the U.S. 

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

agencies, such as the U.S. Food and Drug Administration and the U.S. Environmental Protection 

Agency. The U.S. Departments of Commerce and Agriculture serve as the primary conduits for 

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

and the TPSC Subcommittee.

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

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

Inquiry Point and Notification Authority (U.S. TBT Inquiry Point) at NIST, the Trade Compliance 

Center (TCC), the Office of Standards Liaison, and the U.S. Commercial Service (UCS) in the U.S. 

Department of Commerce; the Foreign Agricultural Service (FAS) and its Office of Agreements 

and Scientific Affairs (OASA) in the U.S. Department of Agriculture and its officers in U.S. 

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

USTR. U.S. Government outreach and consultations with U.S. stakeholders generates much of the 

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

To disseminate information to U.S. stakeholders on proposed foreign notifications of standardsrelated measures, the U.S. Inquiry Point operates a web based service, Notify U.S., which 

automatically notifies registered stakeholders of measures proposed and adopted by other WTO 

Members in sectors of interest.38 These notifications alert U.S. firms and other interested 

 38 Available at https://tsapps.nist.gov/notifyus/data/index/index.cfm
32

stakeholders of their opportunity to comment on proposed foreign measures that may have an 

impact on their exports. U.S. stakeholders may provide their comments directly to the WTO 

Member concerned, if its domestic processes so provide, or through the U.S. Inquiry Point, which 

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

Member. U.S. stakeholders, by providing comments through the U.S. Inquiry Point, alert Federal 

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

In 2013, the U.S. TBT Inquiry Point distributed 2,139 WTO TBT notifications to registered 

stakeholders, including 103 U.S. notifications. The U.S. TBT Inquiry Point processed 266 requests 

for information on standards and technical regulations and fulfilled 431 requests for full text 

documents associated with TBT notifications. The U.S. TBT Inquiry Point distributed 196 U.S. 

Government and industry comments to other WTO Members and circulated 34 WTO Member 

comments on U.S. measures, as well as 54 WTO Member replies to U.S. comments, to relevant 

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

WTO Members in sectors of interest through Notify U.S. (which added more than 450 new 

subscribers in 2013), and contact U.S. officials through the government channels listed above to 

obtain further information, to contribute to the submission of U.S. comments, and to coordinate 

follow up actions. The U.S TBT Inquiry Point hosted or participated in training for nine U.S. and 

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

During 2013, the U.S. Department of Commerce’s International Trade Administration consolidated

its business divisions, reducing them from four to three units to better align key functions to support 

U.S. businesses and their workers. The new units are Enforcement and Compliance (E&C), Global 

Markets (GM), and Industry and Analysis (I&A), which include experts on enforcement of U.S. 

trade laws and compliance with trade agreements, country and regional issues, and industry issues, 

respectively. The Office of Trade Agreements Negotiations and Compliance (TANC) in E&C 

coordinates TBT related work at the U.S. Department of Commerce, including representing the U.S. 

Department of Commerce on interagency teams dealing with TBT and regulatory coherence issues 

and serving as the U.S. Department of Commerce member of the U.S. delegation to the WTO TBT 

Committee. TANC also leads the Trade Agreements Compliance (TAC) Program, which supports 

the enforcement of over 250 international trade agreements to which the United States is a party. 

The GM unit works with U.S. companies to help them expand market access opportunities 

abroad. GM has specialists at the U.S. Department of Commerce’s headquarters, as well as in 100 

U.S. cities and in 73 countries around the world, including Standards Attachés in four key markets 

(Mexico, Brazil, the EU and China) to provide on the ground assistance for U.S. companies with 

standards-related trade issues. The I&A unit, including the new Office of Standards and Investment 

Policy focuses on industry or sector specific negotiations, standards development, and good 

regulatory practice and capacity building in APEC and the Association of Southeast Asian Nations 

(ASEAN), among other fora. It also shares with USTR primary responsibility for administering the 

Industry Trade Advisory Committee on Standards and Technical Trade Barriers.

Through the TAC Program, the U.S. Department of Commerce supports the enforcement prong of 

the NEI by coordinating efforts and resources within the Department to systematically monitor, 
33

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 U.S. Department of Commerce assembles teams of 

specialists to investigate market access problems, including those involving standards-related 

measures, as well as to develop strategies to address them. Compliance team’s work with affected 

companies or industries to establish objectives and to craft and implement compliance action plans 

to achieve or improve market access.

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

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

through the TAC Program. This informs the TPSC’s development of the appropriate U.S. position 

in the various multilateral and bilateral forums for addressing standards-related measures. 

Compliance officers also provide on the ground assistance at U.S. embassies in China, India, El 

Salvador, and at the U.S. Mission to the European Union in Brussels. Free, online tools include the 

texts of more than 250 non-agricultural trade agreements plus a checklist of the kinds of trade 

barriers that the TAC Program can help exporters overcome.

The Department of Agriculture’s Foreign Agricultural Service (FAS) provides a conduit for queries 

and comments on foreign standards-related measures in the agricultural sector. The Office of 

Agreements and Scientific Affairs (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 agencies, to develop 

comments and positions on specific foreign standards- related measures. As a way to streamline 

processes and make information more accessible for U.S. agricultural exporters, OASA established 

a trade facilitation desk. The one stop service helps U.S. exporters navigate the complexities of the 

export process and makes it easier for them to access opportunities in every corner of the world. 

The trade facilitation desk assists U.S. exporters to obtain information on export certification, 

registration, and the documentation requirements for international trade, as well as alert the U.S. 

Department of Agriculture (USDA) when U.S. food and agriculture shipments are detained or 

refused. In addition, FAS’s overseas offices maintain country specific reporting and alerts that 

highlight foreign commodity specific import requirements. These officers assist with detained 

shipments and help to identify innovative solutions to keep trade flowing. Finally, FAS also 

participates in numerous relevant international organizations, such as Codex Alimentarius, to 

proactively address agriculture-related trade concerns arising from foreign standards-related 

measures.

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

Industry and Agriculture Trade Advisory Committees (ITACs and ATACs, respectively). The 

ITACs and the ATACs help identify trade barriers and provide assessments regarding the practical 

realities that producers face in complying with technical regulations and conformity assessment 
34

procedures. USTR and U.S. Department of Commerce officials meet at least quarterly with the 

ITAC on Standards and Technical Trade Barriers (ITAC 16), which is composed of cleared 

advisors from manufacturers, trade associations, standards developers, and conformity assessment 

bodies.39

In 2013, the ITAC 16 met six times. 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 2013, the six Technical Advisory Committees for Trade in Agriculture (ATACs) 

met 13 times with U.S. Department of Agriculture and USTR officials to provide advice on TBT 

issues affecting specific agricultural sectors and their related products such as animals; fruits and 

vegetables; grains, feed and oilseeds; processed food products; and sweeteners, tobacco, cotton and 

peanuts.

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

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

officials on the TBT TPSC Subcommittee also provide important information on the technical and 

scientific aspects of particular foreign standards-related measures, as well as insights on cooperative 

efforts through international organizations that may be relevant to the issue. The TPSC 

Subcommittee factors the views that regulatory agencies express into the positions that the United 

States takes in multilateral, regional, and bilateral trade discussions regarding standards-related 

measures. Particularly in the area of emerging technologies where standards-related activities are 

nascent, the technical, scientific, and policy advice that regulatory agencies provide is critical in 

formulating U.S. views.

Engagement in Voluntary Standards Activities

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

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

Federal agencies also actively engage, or play a convening role in standards development. In 

January 2012, Principles for Federal Engagement in Standards Activities to Address National 

Priorities40 were sent by USTR, OMB, and Office of Science and Technology Policy (OSTP) to 

agencies to clarify principles guiding Federal agencies’ engagement in standards activities. The 

memorandum emphasizes the strengths of the U.S. standards model of private sector leadership but 

notes that where a national priority has been identified in statute, regulation, or Administration 

policy, active engagement or a convening role by the Federal Government may be needed to 

accelerate standards development and implementation to spur technological advances, promote 

market based innovation, and encourage more competitive market outcomes. The memorandum 

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

40 Available at http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08.pdf
35

establishes five “fundamental strategic objectives” for Federal Government engagement in 

standards activities:

• produce timely, effective standards and efficient conformity assessment schemes that are 

essential to addressing an identified need;

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

and policy objectives;

• promote standards and standardization systems that promote and sustain innovation and 

foster competition;

• enhance U.S. growth and competitiveness and ensure non-discrimination, consistent with 

international obligations; and

• facilitate international trade and avoid the creation of unnecessary obstacles to trade.

Circular A-119 also addresses Federal agencies’ participation in standards development. 
36

IX. U.S. ENGAGEMENT ON STANDARDSRELATED MEASURES IN INTERNATIONAL,

REGIONAL, AND BILATERAL FORA

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

The United States pursues a broad agenda and active engagement with foreign governments to 

prevent unnecessary obstacles to trade and to resolve specific trade concerns arising from standardsrelated measures. As noted above, the WTO TBT Committee is the principal multilateral forum for 

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

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

prevent and resolve standards-related trade concerns. In addition, U.S. agencies seek to prevent 

potential standards-related trade barriers from emerging by engaging in multilateral, regional, and 

bilateral cooperative activities, information exchanges, technical assistance, and negotiations on 

specific agreements. These efforts are aimed at helping other governments design effective and 

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

and facilitating trade.

U.S. Government cooperative efforts and information exchanges with other countries can assist 

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

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

including the United States, and strategies to meet those requirements consistently. Cooperative 

activities can also serve to prevent localized high profile incidents of the type that can disrupt trade 

across all markets and damage both producer reputations and consumer confidence. Close 

coordination among trade, regulatory, and standards officials with highly specialized technical 

expertise among other things 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, the U.S. Department of Commerce’s

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

and NIST’s Standards in Trade Program. USDA’s FAS also provides technical assistance on 

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

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

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

the United States negotiates bilateral, regional, and multilateral MRAs with U.S. trading partners. 

These agreements establish procedures for each party to accept the results of conformity assessment 

procedures for specified products carried out in the other party’s territory or to accept the other 
37

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.41 It also maintains a listing of the accreditation requirements for conformity 

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

has designated pursuant to each MRA as competent to perform tests or certify products to ensure 

they conform to the other MRA party’s technical requirements. The Federal Communications 

Commission website provides useful background information on U.S. MRAs in the 

telecommunications sector and examples of how they work.42

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

arrangements with other governments. The United States has now exchanged three organic 

equivalency arrangements. The first organic equivalency arrangement concluded with Canada in 

2009, the second with the EU in 2012, and the third with Japan in 2013.

(U.S. engagement on standards-related measures in various international and regional fora is 

detailed below. U.S. bilateral engagement with its trading partners on standards-related measures 

is detailed in individual Country Specific Reports in Section XI.)

WTO TBT Committee and Related Engagement

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

barriers to trade through the focused WTO Member driven agenda of the WTO TBT Committee. 

The WTO TBT 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 WTO 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 2013, the United States raised specific trade concerns regarding on average 20 to 30 foreign TBT 

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

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

42 Available at http://transition.fcc.gov/oet/ea/mra/
38

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 WTO TBT Committee sessions 

are described in Section XI of this report. As elaborated in Section XI, U.S. interventions in the 

TBT Committee, and on its margins, have helped resolve a number of standards-related 

concerns affecting U.S. trade.) The Committee’s annual review of its activities is contained in 

G/TBT/29, which includes a thumbnail description of the specific trade concerns that WTO 

Members raised and identifies the Members that raised them.

Systemic Issues

The TBT Agreement calls for the WTO 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.11, which are intended to strengthen and improve the operation of the TBT 

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

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

implement their TBT obligations.

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

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

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

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

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

and use of international standards for conformity assessment; (3) implementation of the Code of 

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

international standards development set out in the 2000 Committee Decision, with particular focus 

on the development dimension and transparency.

In 2013, with a view to implementing the goals of the 6th Triennial Review, the WTO TBT 

Committee held special thematic sessions on Good Regulatory Practices, Standards Development,

Special and Differential Treatment, Capacity Building and Operations of the WTO Inquiry Points.

Technical Assistance and Capacity Building

Standards Alliance

The United States also launched a new assistance facility called the “Standards Alliance” in 

November 2012 to help build capacity among developing countries to implement the TBT 

Agreement. The Standards Alliance will help developing countries strengthen implementation of 

the TBT Agreement, including by helping them to improve their notification practices and domestic 

practices related to adopting relevant international standards and to clarify and streamline their 

regulatory processes for products. This program aims to reduce the costs and bureaucratic hurdles 
39

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

particularly in developing markets.

In May 2013, USAID and ANSI entered into a partnership that will coordinate private sector 

subject matter experts from ANSI member organizations to deliver training and facilitate technical 

exchanges with interested Standards Alliance countries.

The project will include activities in up to ten markets representing a variety of geographical 

regions and levels of economic development. In consultation with U.S. Government and private 

sector experts, ANSI reviewed the applications received with consideration of bilateral trade 

opportunities, available private sector expertise, demonstrated commitment and readiness for 

assistance, and potential development impact. Participating countries or regions for the first year 

will include: Central America (CAFTA-DR, Panama), Colombia, East African Community, 

Indonesia, Middle East and North Africa, Peru, Southern Africa Development Community, 

developing ASEAN members, and Yemen.

Standards Alliance programming accomplishments in 2013 include a bilateral workshop on Good 

Regulatory Practices with Indonesia in June 2013, and a series of programs with Peru held between 

July and September 2013 on standards development, conformity assessment, good regulatory 

practices, and implementation of the WTO Agreement on Technical Barriers to Trade, conducted in 

both in Peru and the United States.

Total Economic Engagement Program

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

technical assistance and capacity building to developing countries to advance a more collaborative 

and open standardization and regulatory process, to increase developing country regulators’

exposure to the views of the private sector, and to foster greater regulatory alignment and 

convergence. TEE works with foreign governments, trade associations, and standards setting 

bodies on key public-private partnerships.

For example, in 2013 the TEE program supported regional workshops in the United Arab Emirates 

and Egypt to address automotive standards concerns in the Middle East and North Africa region. 

Regulators from the U.S. National Highway Traffic Safety Administration, and the U.S. Federal 

Motor Carrier Safety Administration, along with automotive industry associations and automobile

makers, engaged in technical exchanges with regulators and national standards body representatives 

from a number of economies on vehicle safety and emissions standards and regulatory requirements 

currently being updated.

There was also ongoing work with the Russian Federation on implementation of Russia’s WTO 

commitments that included a TBT and standards best practices exchange seminar aimed at 

preventing technical barriers to trade.

In 2013, the TEE also supported an information exchange between Brazil’s medical device 
40

regulatory agency (ANVISA), the U.S. Food and Drug Administration and industry on international 

medical device regulatory harmonization efforts and best practices in medical device regulation.

U.S. Department of Commerce Commercial Law Development Program

In 2013, the CLDP program has been engaged in capacity building to assist countries in 

implementing the obligations of the WTO Agreement on Technical Barriers to Trade. The CLDP 

programming included orientation visits of Iraqi officials to the United States in April 2013 and a 

capacity building program on implementation of the WTO Agreement on Technical Barriers to 

Trade for several of the Middle East and Northern African trading partners in cooperation with the 

Gulf Standards Organization in May 2013. Because of CLDP capacity building efforts, Morocco, 

Jordan and Yemen joined the Standards Alliance program in 2013.

Association of Southeast Asian Nations

The Association of Southeast Asian Nations (ASEAN) was established as a regional organization in 

1967 to accelerate economic growth, promote regional peace and stability, and enhance cooperation 

on economic, social, cultural, technical, and educational matters among Southeast Asian countries. 

Member states include Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, 

Singapore, Thailand, Vietnam, and the Philippines. 

The United States supports deepening commercial engagement with ASEAN under the United 

States-ASEAN Expanded Economic Engagement (E3) Initiative, under the ASEAN-U.S. Trade and 

Investment Framework Arrangement. The E3 Initiative is intended to help lay the groundwork for 

ASEAN countries to pursue high-standard trade agreements, such as the TPP, and includes an 

element of cooperation on standards development and practices. 

The U.S Department of Commerce carries out the standards cooperation work under the ASEAN 

Consultative Committee on Standards and Quality (ACCSQ), and is supported by funding from 

USAID. The focus is on sectors that appear on both ASEAN’s list of 12 Priority Sectors and in the 

U.S. National Export Strategy with the objective of encouraging good regulatory practices and the 

use of international standards, and increasing ASEAN participation in international regulatory 

cooperation activities to facilitate trade and reduce nontariff barriers. Priority sectors include 

medical devices, building products, dietary supplements, food safety, green chemistry, electrical 

and electronic goods, and information and communications technology (ICT) products. This work 

helps ensure that U.S. products have access to the ASEAN regional market.

In 2013, activities included programs on medical device regulatory capacity building, green 

building codes and building information modeling to facilitate green commercial construction, food 

incident management and building SME capacity in food safety standards, and the application of 

“green chemistry” to specific industries. Food safety and green building activities are carried out 

jointly with the APEC Sub-Committee on Standards and Conformance (SCSC) and Food Safety 

Cooperation Forum (FSCF).
41

Asia Pacific Economic Cooperation

APEC 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, 

7 of the top 15 trade partners of the United States are Members of APEC. In 2013, Indonesia hosted 

APEC and focused on three areas: attainment of the Bogor Goals, the achievement of sustainable 

growth with equity, and the promotion of connectivity.

Underscoring its commitment to engage the Asia Pacific region on a range of economic and other 

issues and support APEC’s goal of regional integration, the U.S. Government launched the United 

States-APEC Technical Assistance to Advance Regional Integration (US-ATAARI) program in 

November 2013. The program will be a five year project co-managed by USAID Regional 

Development Mission for Asia and USAID’s Washington based Office of Trade and Regulatory 

Reform within the Bureau for Economic Growth, Education, and Environment with funding and 

strategic direction from the U.S. Department of State’s Office of Economic Policy within the

Bureau of East Asian and Pacific Affairs. The funds are currently anticipated to be $27.5 million 

for the life of the project.

US-ATAARI builds upon past assistance provided to APEC economies by the U.S. Government by 

delivering targeted technical assistance, ranging from policy studies and assessments to capacity 

building, training and expert advice on integration, trade liberalization and institutional 

management. The project is designed to support regional economic integration within the APEC 

region via activities that support ongoing work within each of APEC’s three pillars (trade and 

investment liberalization; business facilitation; and economic and technical cooperation), and that 

align with U.S. foreign policy priorities. 

Work on standards related measures takes place in the SCSC where the United States continues to 

play a leadership role in encouraging the SCSC to focus on good regulatory practice in specific 

sectors and initiating early regional engagement in emerging technology areas so that standards and 

conformity assessment measures do not become unnecessary obstacles to trade. The United States 

currently leads three multiyear projects in the SCSC on food, green building and wine, and will 

continue work on the energy efficiency of ICT products with a new project in 2014.

Electric Vehicles Standards

The United States is working with other APEC economies that may choose to regulate electric 

vehicles. This initiative is aimed at promoting the production and use of electric vehicles by 

preventing economies from developing unique regulatory approaches and creating unnecessary 

regulatory divergences. To prepare for a dialogue on this topic in May 2014 in Qingdao, China, the 

United States is drafting two analytical pieces: (1) a literature review on existing international 
42

standards for electric vehicles; and (2) a study on how APEC economies are currently regulating in 

this space. We are working with China, Japan, and other interested APEC economies to produce 

recommendations for Leaders to consider in November on promoting alignment of international 

electric vehicle standards.

Good Regulatory Practice

APEC economies recognized the importance of GRPs, addressing unnecessary technical barriers to 

trade, and advancing regulatory convergence and coherence. In June 2013, Indonesia hosted the 7th 

Conference on Good Regulatory Practice in Medan, Indonesia. The conference assessed progress 

made by economies towards implementing the 2011 APEC Leaders’ commitment to strengthen the 

implementation of GRPs by ensuring internal coordination of rulemaking, assessing the impact of 

regulations, and conducting public consultations and highlighted the role that standards and 

conformity assessment play in supporting GRPs. Participants supported efforts in APEC to 

improve transparency through mechanisms that develop single websites for regulatory information, 

encouraged APEC economies to engage in retrospective review of regulations, and called for 

capacity building and education efforts with regulators, government officials, and industry to build 

support and understanding of GRP.

The United States also funded a study, “Good Regulatory Practices for Conformity Assessment in 

APEC Member Economies.” This study examined the conformity assessment procedures in 

Member economies and how they incorporate GRPs with respect to conformity assessment and 

ensure protection of health, safety, and the environment without creating unnecessary barriers to 

trade. The study gave particular focus to the electrical installations, photovoltaic, and medical 

devices/pacemakers sectors. APEC also completed a progress report on its work to update the 

“Baseline Study of Good Regulatory Practices in APEC Member Economies,” scheduled to be fully 

completed by the Third Senior Officials’ Meeting (SOM 3) in 2015.

The United States also hosted a workshop in Washington, D.C., on November 12 to 15, 2013 on the 

benefits and use of electronic rulemaking, which help advance the 2014 goals of improving public 

consultations in the Internet era.

In 2014, we are seeking to have APEC Leaders commit to undertaking a series of actions by 2020 

on improving public consultations on proposed regulations through information technology, making 

APEC a global leader in this area. We are also seeking Leaders’ establishment of a capacity 

building plan to assist economies’ implementation of these commitments. To support this effort,

the United States is developing a study on stakeholder and regulator experiences with using 

information technology in their public consultations.

Green Buildings

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

in which they have a competitive advantage, such as products related to plumbing, lighting, 
43

flooring, HVAC systems, and fixtures. The United States launched work on green building 

standards, codes and rating systems in 2011, building on the direction from Leaders and Ministers 

to support the transition towards low carbon economies in the Asia Pacific region. Green building 

is a new technology area where there is an opportunity to ensure that the standards and conformity 

assessment requirements that underpin trade in these technologies do not create unnecessary trade 

barriers for U.S. industry. Greening the commercial building sector can also yield significant 

energy savings since the commercial building sector accounts for approximately 40 percent of 

energy usage in most industrialized economies.

Work in 2013 focused on building codes and building information modeling (BIM) as the United 

States began to implement activities under a new multiyear project on green building. In March 

2013, Peru and the United States organized a workshop on green codes in Lima, Peru, which was 

followed by the completion of a comprehensive study: APEC Building Codes, Regulations and 

Standards: Minimum, Mandatory and Green. In June 2013, a second workshop explored how BIM 

can be utilized to drive green building by delivering concrete benefits in the planning, design, 

construction and operation of buildings; economies can assess progress in BIM utilization using an 

APEC BIM Quick Start Guide. The United States is working together with the ASEAN ACCSQ on 

the green building project.

In 2014, work on green buildings will continue in APEC. The 2014 APEC Conference on 

Standards and Conformance for Green Technologies, scheduled to be held in Beijing, China in 

August will include sessions on green codes and BIM.

Wine Regulatory Forum

The SCSC created a Wine Regulatory Forum (WRF) in 2008 to promote trade facilitating 

regulation of wine. Regulatory coherence in the APEC region is a priority because wine trade has 

grown dramatically in importance for developing and exporting economies. The value of this trade 

increased from $1.1 billion in 2000 to $3.6 billion in 2010, however, a growing number of 

unnecessary nontariff barriers estimated to cost businesses (primarily SMEs) approximately $1 

billion a year, impedes trade in wine.

In 2011 and 2012, APEC WRF meetings focused on promoting regulator dialogue and cooperation, 

exchanging current practices, educating economies on wine’s low risk profile, and building 

confidence in each country’s regulatory regime. In 2013 the United States, through a multiyear 

project, continued to build on the outcomes of those meetings by assisting developing economies to 

implement specific, measurable good regulatory practices with respect to wine regulation. Through 

active participation in the project, these economies will gain improved assurance of the safety of 

imported wine. A reduction in unnecessary impediments to trade, such as redundant export 

certificate requirements, and a better understanding of foreign regulatory regimes and wine science, 

will lead to increased opportunities for developing economy wine exports. The first activity under 

the project occurred in November 2013 when the WRF held a technical meeting in Washington in 

conjunction with the World Wine Trade Group meeting. In September 2014, The WRF will meet 
44

again in Beijing, China in conjunction with the Food Safety Cooperation Forum to discuss 

improving regulation acceptance of export certificates and to more closely align practices on 

Maximum Residue Limits (MRLs) for pesticides.

The SCSC multiyear projects on wine and food safety share a connection in that the FSCF is 

working on a regulatory roadmap for pesticide MRLs that has identified wine grape MRLs as a pilot 

area. Wine regulators are engaged in the FSCF working group on MRLs.

ICT Energy Efficiency

The SCSC has already completed two workshops on ICT energy efficiency since 2011. APEC 

recently awarded funding for a new U.S. led project to continue advancing regional alignment to 

IEC standards and conformity assessment procedures for laptops and personal computers, and an

ICT Energy Efficiency Regulators Forum has been created so APEC economies can regularly 

discuss this topic. This work has the strong support of the U.S. ICT industry. Plans call for the ICT 

workshop to be held during SOM 3 in Beijing, China in August 2014 as part of the APEC 

Conference on Standards and Conformance for Green Technologies.

Trans-Pacific Partnership

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

negotiations to conclude a comprehensive Asia Pacific trade agreement, the Trans-Pacific

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

investment opportunities in the Asia Pacific by negotiating an ambitious, 21st century regional trade 

agreement. In addition to the United States, the TPP negotiations currently include: Australia, 

Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and 

Vietnam. The twelve countries have made considerable progress toward concluding the 

negotiations, including on standards-related issues, on which the United States is seeking to 

establish rules and disciplines for standards-related measures that reduce or eliminate unwarranted 

barriers to trade.

In 2013, the TPP Technical Barriers to Trade negotiating group made substantial progress toward 

conclusion of the TBT chapter and several sector specific annexes. The TPP TBT Chapter will 

build on the WTO TBT Agreement and include obligations on regulatory transparency, the use of 

GRPs, the acceptance of the results of conformity assessment procedures carried out in TPP 

countries, and international standards. It will also set out a framework for addressing trade 

concerns and for advancing cooperative activities on standards-related measures.

The TPP also will have sector specific annexes including obligations regarding the development 

and implementation of standards-related measures to address unnecessary barriers to trade in 

cosmetics, pharmaceuticals, medical devices, information and ICT, wine and spirits, organics, 

footwear and food formulas.
45

Transatlantic Trade and Investment Partnership

On June 17, 2013 President Obama and EU leaders launched negotiations on a comprehensive trade 

and investment agreement, the Transatlantic Trade and Investment Partnership (T-TIP), with the 

objective of increasing jobs, economic growth and competitiveness on both sides of the Atlantic.

Given that T-TIP’s potential benefits stem in large part from the parties’ ability to significantly 

reduce or eliminate nontariff barriers, addressing nontariff barriers in the form of regulatory 

restrictions that impose significant costs, create unnecessary barriers, reduce efficiency in the 

transatlantic market, and limit the capacity of U.S. and EU firms to innovate and compete in global 

markets, is a key aspect of achieving the more integrated transatlantic marketplace envisaged by 

TTIP. Thus, in the negotiations the United States seeks to reduce such barriers and prevent future

ones, while ensuring our continued ability to regulate to achieve health, safety, environmental and 

other legitimate regulatory objectives.

In order to deliver an agreement that will be a driver of job creation, economic growth and 

competitiveness, the United States is seeking with respect to nontariff barriers and regulatory issues 

to establish new rules and obligations in T-TIP to strengthen the ability of U.S. and EU firms to 

compete globally, as well as support the multilateral trading system through approaches consistent 

with most favored nation and national treatment. The U.S. view is that such ambitious outcomes 

can be achieved if they are based on regulatory approaches that have long been observed to support 

and enable successful economic growth, market integration and removal of trade barriers, such as 

policies promoting transparency and accountability, innovation, open markets and competition. For 

the United States, a natural point of departure is to draw from, build on, and move beyond the broad 

array of current commitments, guiding principles and good practices agreed over the past twenty 

years through the WTO, the OECD and other organizations, as well as in United States-European 

Union cooperation efforts on trade and regulatory issues.

The negotiations on regulatory issues are proceeding on the basis of the five elements on regulatory 

issues and nontariff barriers contained in the final report of the United States-European Union HighLevel Working Group (HLWG, issued on February 11, 2013:

• An ambitious “SPS-plus” chapter, including establishment of an ongoing mechanism for 

improved dialogue and cooperation on addressing bilateral sanitary and phytosanitary (SPS) 

issues. The negotiations will build upon the key principles of the SPS Agreement, including 

the requirements that each side’s SPS measures be based on science and on international 

standards or scientific risk assessments, applied only to the extent necessary to protect 

human, animal, or plant life or health, and developed in a transparent manner, without undue 

delay. 

• An ambitious “TBT-plus” chapter, building on horizontal disciplines in the TBT Agreement, 

including establishment of an ongoing mechanism for improved dialogue and cooperation 

for addressing bilateral TBT issues. The objectives of the chapter are to yield greater 

openness, transparency, and convergence in regulatory approaches and requirements and 

related standards development processes, as well as, inter alia, to reduce redundant and 
46

burdensome testing and certification requirements, promote confidence in our respective 

conformity assessment bodies, and enhance cooperation on conformity assessment and 

standardization issues globally.

• Cross cutting disciplines on regulatory coherence and transparency for the development and 

implementation of efficient, cost effective, and more compatible regulations for goods and 

services, including early consultations on significant regulations, use of impact assessments, 

periodic review of existing regulatory measures, and application of good regulatory 

practices.

• Provisions or annexes containing additional commitments or steps aimed at promoting 

regulatory compatibility in specific, mutually agreed goods and services sectors, with the 

objective of reducing costs stemming from regulatory differences in specific sectors, 

including consideration of approaches relating to regulatory harmonization, equivalence, or 

mutual recognition, where appropriate. 

• A framework for identifying opportunities for and guiding future regulatory cooperation, 

including provisions that provide an institutional basis for future progress. 

All but the SPS-plus element are related to TBT. The U.S. negotiating objectives in these five areas 

are based on the domestic consultation procedures undertaken with Congress, the Trade Policy Staff 

Committee (TPSC), and the public. The TPSC received over 370 submissions from a range of 

interests, many pertaining to the regulatory area. The submissions emphasized the following 

concerns on standards and regulatory issues: 

• U.S. persons are not able to participate directly and effectively in the development of 

regulations, standards and conformity assessment procedures in the EU. In particular, some 

institutional arrangements in the EU appear to either accord exclusive rights to, or 

effectively favor, EU entities in the development and implementation of such measures. 

Further, there appears to be no effective mechanisms to ensure accountability to non-EU 

interests in the adoption and implementation of such measures;

• U.S. producers and exporters – particularly those without an established presence in the EU 

– are often disadvantaged by the technical and administrative requirements that result from 

the EU’s promulgation of standards, conformity assessment procedures and regulations in 

inflexible, closed systems. U.S. exports can be further limited by third country adoption of 

EU standards and regulations as a result of their bilateral trade agreements with the EU and 

EU technical assistance; and

• Efforts to enhance regulatory compatibility and standards alignment between the United 

States and the EU have often been frustrated by a lack of clarity and transparency regarding 

EU decision making processes; lack of consistency and accountability regarding adherence 

to science and evidence based decision making; and lack of flexibility to consider standards 

of global relevance if they have been promulgated in a setting outside Europe. For example, 

the EU limits the array of standards that it recognizes, often leading to the EU adopting and 

implementing standards-related measures that lack market relevance, and are not sufficiently 

performance oriented or evidence based. 
47

Accordingly, the overarching U.S. objectives in negotiations on regulatory issues in T-TIP are to 

achieve commitments that will lead to greater openness in regulatory and standards-development, 

risk analysis, impact assessment, and conformity assessment processes. U.S. producers, exporters 

and citizens possess important information, perspectives and ideas that – if taken into account by 

EU regulatory authorities in a timely, effective and accountable manner – could help ensure 

mutually beneficial outcomes. In the U.S. view, T-TIP presents an opportunity to move towards a 

more integrated transatlantic marketplace and a more compatible U.S.-EU approach to the 

development of standards and regulations in the United States and the EU and in third countries. TTIP also presents an opportunity to explore how procedural openness and accountability throughout 

the regulatory rulemaking process can assist and support the achievement of greater alignment in 

specific sectors.

Indeed, in public remarks on September 30, 2013, U.S. Trade Representative Froman stressed that 

T-TIP must address differences in the U.S. and EU approaches to standards and regulations that 

have created unnecessary barriers – raising costs, deterring trade and investment, and negatively 

affecting our competitiveness and our consumers. He stressed that standards and regulatory issues 

have emerged as the greatest potential impediment to further integration of the world’s two largest 

markets, and stated that T-TIP should embed the principles of transparency, participation and 

accountability to produce better regulations and mitigate many of the tensions the United States and 

EU face around regulatory divergences. Specifically, he noted the importance of:

• Transparency: Providing adequate advance notice of specific regulatory measures, not just 

preliminary, general papers on the subject, but the actual rule being proposed; 

• Participation: Providing meaningful opportunities for input from a broad range of 

stakeholders, public and private, foreign and domestic; and

• Accountability: Providing responses to that input, a rationale for the final regulatory 

decision, based on evidence and science, including an impact analysis of the proposed 

regulation.

In 2013, the United States pursued these objectives through three rounds of negotiations. In 2014, 

we will continue to pursue the objective of reducing unnecessary regulatory barriers to trade while 

maintaining our high levels of health, safety, and environmental protection, and expanding 

transatlantic opportunities for U.S. producers and exporters. In addition, the public will continue to 

have an important role in continuing to shape our negotiating objectives. While the regulatory 

issues in T-TIP present considerable challenges, the United States is committed to reaching an 

ambitious, comprehensive agreement.

Free Trade Agreement – TBT Chapter Meeting
48

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

Technical Barriers to Trade was held in Washington, DC, on September 26, 2013. The two 

governments discussed their respective systems as well as particular issues such as nutritional

labeling and use of biotechnology. The Peruvian delegation also visited dozens of stakeholders, and 

several regulatory agencies including the U.S. Food and Drug Administration (FDA) and CPSC, 

under USAID’s Standards Alliance Program.

Regulatory Cooperation Fora

Executive Order 13609

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

International Regulatory Cooperation to help reduce, eliminate, and prevent unnecessary 

differences in regulatory requirements imposed by U.S. and foreign regulators, which can limit the 

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

Regulatory Working Group established by E.O. 12866, and reaffirmed by E.O. 13563, to serve as a 

forum to discuss, coordinate, and develop a common understanding among agencies of U.S. 

Government positions and priorities with respect to: international regulatory cooperation activities 

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

Government to support significant, cross cutting international regulatory cooperation activities; and 

promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory 

approaches, as appropriate.

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

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

regulatory best practices and aligning regulatory approaches in economically significant sectors 

with the European Union, Canada, and Mexico.

European Union

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

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

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

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

the Transatlantic Economic Council (TEC) and the United States – European Union 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 four TEC meetings to identify 

projects for the TEC to consider.

Mexico
49

In May 2010, President Obama and Mexican President Calderón committed to enhance 

significantly the economic competitiveness and the economic wellbeing of the United States and 

Mexico through improved regulatory cooperation. The Presidents directed the creation of United 

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

regulatory, trade, and foreign affairs officials from each country.

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

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

motor vehicle safety, and e-health and conformity assessment. On October15, 2012, the HLRCC 

met to review progress on the seven work plans. It is expected a new consultation schedule will 

commence in 2013 to update the activities of the HLRCC.

The HLRCC reconvened August 15-16, 2013 in Mexico City to discuss progress of the seven work 

plans, and discuss the path forward for a new biennial work plan which will be drafted and finalized 

in 2014 for implementation in 2015.43

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 mandate to promote 

economic growth, job creation, and benefits to U.S. and Canadian consumers and businesses by 

enhancing regulatory transparency and coordination, with a focus on sectors characterized by high 

levels of integration, significant growth potential, and rapidly evolving technologies. The RCC 

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

cooperation on topics such as, agriculture, personal care products, pharmaceuticals, and motor 

vehicles.

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

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

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

The RCC met in Washington, D.C., on June 19, 2013, to discuss work under the 2011 Joint Action 

Plan, the next steps in furthering United States-Canada regulatory alignment, and the role of the 

Council moving forward.

North American Leaders Summit – Trilateral Regulatory Cooperation

On February 19, 2014, President Obama met in Toluca, Mexico, with President Peña Nieto of 

Mexico and Prime Minister Stephen Harper of Canada for the North American Leaders Summit. 

 43 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
50

They discussed their vision for a prosperous and secure future for the citizens of all three countries 

and their shared commitment to work together to realize that vision. They announced concrete 

initiatives by the three countries aimed at enhancing North American competitiveness in the global 

economy, expanding opportunities for citizens, and promoting peace, security, and development 

through multilateral action. Some of these initiatives include: strengthening trilateral regulatory 

cooperation in order to ease burdens on business, including establishing in-country exchanges of 

regulators, and creating an outreach mechanism to increase stakeholder input, including from civil 

society.
51

X. COUNTRY REPORTS

Argentina

Bilateral Engagement

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

Testing Requirements for Lead in Graphic Products (Resolution 453)

As previously reported in the 2013 TBT report, the United States continues to be concerned with 

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

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

Resolution 453/2010 required testing to be conducted in one of two designated laboratories in 

Argentina. The United States expressed concern during WTO TBT Committee meetings in 

November 2011 and March 2012 that this resolution appeared to apply to foreign producers only, 

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

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

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

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

Argentina temporarily accepted a sworn declaration from the producer or importer stating that the 

product, or group of similar products, complies with the applicable norm, ASTM D 3335-85a, in 

lieu of testing at the designated laboratories in Argentina. In September 2012, Argentina also 

exempted from Resolution 453/2010 testing requirements for all printed materials destined for 

distribution or use in fairs, exhibitions, or other events that are declared “of interest” by the Ministry 

of Tourism. This alternative procedure, however, phased out in stages, and ended in November 

2013.

Both the United States and the European Union raised concerns with this testing requirement during 

the March and June 2012 WTO TBT Committee meetings. The United States indicated that it 

continues to question whether mandatory third party testing should be required for these products 

since they are low risk, and whether it is necessary for the testing to be performed in Argentina 

itself or instead could be performed by any accredited laboratory. The United States will continue 

to press Argentina on this issue in 2014.

Electrical and Electronic Products – Conformity Assessment Procedures

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

modifying Resolution 92/98, became effective January 1, 2013, but Argentina has not notified the 

resolution modification to the WTO. The modified Resolution 92/98 specifies the process by which 

foreign manufacturers and importers obtain the S-mark safety certification from local certification 

bodies. This certification is required to market electrical and electronic products between 50 and 
52

1000 Vac in Argentina.

According to U.S. industry, changes to Resolution 92/98 impose repetitive testing and associated 

delays, resulting in costs for U.S. exporters that outweigh the purported safety benefits. An 

importer with a recognized foreign certificate that had served as a basis for certification under 

Resolution 92/98 must now also have the product tested locally. This requirement is mandatory for 

all electrical products, rather than a class of electrical products based on risk. In addition, industry 

reports that the requirements disproportionately impact foreign manufacturers and importers and 

favor domestic manufacturers. Failure to follow Resolution 92/98 results in products not clearing 

customs and entering Argentina’s market.

The United States will continue to press Argentina on this issue in 2014.

Brazil

Bilateral Engagement

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

Commercial Dialogue led by Brazil’s Ministry of Development, Industry, and Commerce (MDIC) 

and the U.S. Department of Commerce. Bilateral engagement also includes the Economic 

Partnership Dialogue between the Department of State and the Ministry of External Relations and 

the Commission on Economic and Trade Relations under the Agreement on Trade and Economic 

Cooperation (ATEC) between USTR and MDIC and the Ministry of External Affairs. The two 

governments also liaise during WTO TBT Committee meetings.

Medical Devices – GMP Certificates

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

registering medical devices in Brazil. Resolutions 24 and 25, notified to the WTO in May 2009 and 

also known as Public Consultation 11, establish the requirements for manufacturers to submit a 

Certificate of Good Manufacturing Practice for registration of health products. Resolutions 24 and 

25 define a health product as a product that fits into one of two categories, either a medical product 

or a product for in vitro use diagnosis. As of May 2010, applicants have had to submit to Brazil’s 

National Health Surveillance Agency (ANVISA), a Good Manufacturing Practices (GMP) 

certificate with their application for registration of health products in Brazil. ANVISA issues a 

GMP certificate only after it has inspected the manufacturing premises. A manufacturer must 

obtain the GMP certificate to access the Brazilian market, however, according to discussions in the 

2013 WTO TBT Committee meetings, the average waiting time from submitting the inspection 

request until completing the inspection is twenty months, while U.S. industry reports a wait time of 

up to three years. This is significantly longer than the average time of three months for similar 

inspections performed by other accredited auditing bodies. This delay hinders medical device 

exports to Brazil.
53

The United States and other WTO Members raised this issue with Brazil at all three meetings of the 

WTO TBT Committee in 2013. The United States pressed ANVISA to accept existing GMP 

certificates without inspection or to consider subcontracting overseas inspections to accredited 

auditing bodies. 

Brazil published Decree 8077 in the Brazilian Official Gazette on 14 August 2013, revoking Decree 

79094 of 1977. With this new Decree, ANVISA gained autonomy to define products that would 

require GMP certification for registration, and those cases in which other health authorities or 

accredited bodies' inspection reports could issue the required GMP certification.

On November 12, 2013 Brazil notified Draft Resolution 50 to the WTO, which establishes 

requirements to prove compliance with GMP for registration of medical devices in Brazil. Brazil 

did not indicate an implementation date.

In January 2014 the U.S. FDA, the Australian Therapeutic Goods Administration, ANVISA, and 

the Canadian Health Products and Food Branch began a test of pilot single auditing project to 

strengthen existing mutual cooperation in the scientific and regulatory area of medical devices 

through the development of the Medical Device Single Audit Program (MDSAP). Specifically, 

MDSAP will allow recognized auditing organizations to conduct a single audit of a medical device 

manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities 

participating in the pilot program.

While the MDSAP program is a promising step towards resolving concerns regarding Brazil’s GMP 

certification requirements, industry reports that staffing shortages continue to delay the registration 

necessary to sell medical products in Brazil. In 2013, ANVISA hired and is now training more than 

300 professionals to expedite the registration process. Brazil has also deputized state health 

inspectors to conduct international inspections.

In 2014 the United States will continue to monitor the implementation of medical device 

registration requirements in Brazil.

Telecommunications – Acceptance of Test Results

As discussed in the 2013 TBT Report, the United States continues to be concerned about Resolution 

323 (November 2002) promulgated by Brazil’s National Telecommunications Regulatory Agency. 

Resolution 323, Standard for Certification of Telecommunications Products, requires that in order 

to place products on the market in Brazil products be tested in Brazil, except in cases where the 

equipment is too large or too costly to transport. As a result, U.S. suppliers must present virtually 

all of their information technology and telecommunications equipment for testing at laboratories 

located in Brazil before that equipment can be placed on the Brazilian market. This requirement 

causes redundant testing, higher costs, and delayed time to market. Brazil did not notify Resolution 

323 to the WTO.

The United States has urged Brazil to implement the Inter-American Telecommunication 
54

Commission (CITEL) MRA with respect to the United States. Under the CITEL MRA, two or 

more CITEL participants may agree to provide for the mutual recognition of conformity assessment 

bodies and mutual acceptance of the results of testing and equipment certification procedures 

undertaken by those bodies in assessing the conformity of telecommunications equipment to the 

importing country’s technical regulations. The United States and Brazil are both participants in 

CITEL. If Brazil implemented the CITEL MRA with respect to the United States, it would benefit 

U.S. suppliers seeking to sell telecommunications equipment into the Brazilian market by enabling 

them to have their products tested and certified in the United States to Brazil’s technical 

requirements, eliminating the need for U.S. suppliers to have their products tested and certified in 

Brazil. The United States continued in 2013 to encourage Brazil to implement the CITEL MRA 

with respect to the United States, and will continue engagement with Brazil to this end in 2014. 

Chile

Bilateral Engagement

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

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

meetings, as well as during the WTO TBT Committee meetings.

Nutritional Labelling and Food Advertising 

The Chilean Congress adopted Law No. 20,606 on nutrition and composition of food and food 

advertising on July 6, 2012, and the Chilean Ministry of Health (MOH) published the corresponding 

final implementing regulations in Chile’s Official Journal on December 17, 2013. The regulations 

will be implemented in stages beginning June 17, 2014. The implementing regulations set limits for 

maximum levels of certain nutrients including saturated fat, calories, sugar, and sodium according 

to portion size of specific foods. Chile set nutrient limits for 24 categories of foods, including those 

preferred by children. If the limits in the food categories are exceeded, an icon must be placed on 

the front label panel, indicating the product is "High In" that nutrient. The icon must account for 

approximately 7.5 percent of the total surface of the packaging. Trade in processed and packaged 

foods to Chile amounts to $255 million annually. Chile notified the draft implementing regulations 

and accompanying guidance on advertising to the WTO.

The United States delivered initial WTO TBT comments on February 26, 2013 on a proposed 

version of the implementing regulations. The United States discussed this issue with Chile in the 

framework of the WTO TBT Committee, the United States – Chile FTA, on the margins of the TPP 

Agreement negotiations, and with senior level officials in Santiago. Other countries shared U.S. 

concerns over the proposed labeling requirements. Eleven countries, including the United States, 

expressed concerns at the June 2013 WTO TBT Committee, and eight countries, including the 

United States, spoke at the October 2013 TBT WTO Committee. 

After this engagement, when Chile published the final implementing regulations in December 2013, 
55

they contained significant improvements over previous draft versions. Chile has decreased the total 

size of the icon from 20 percent of the total surface of the package to 7.5 percent. There is a choice 

of background colors of the square (red, blue, or green) where previously red or black was dictated. 

The font for the “High In” declaration is normal where previously it was bold and exaggerated. The 

Ministry of Health declaration inside the icon has been replaced with a statement that ties the icon 

to 2003 World Health Organization (WHO) diet recommendations.

Chile also reduced the number of food categories subject to the requirements substantially from its

original proposal. According to industry, roughly 80 percent of all prepackaged foods might have 

needed the “High In” icons. In narrowing the scope of the food categories, however, Chile created 

questions about the scientific basis for food category selection. Chile also created concerns about 

how it will categorize domestic foods versus imported prepackaged foods. The MOH also made 

some improvements to the nutrient thresholds for yogurt and bread and standardized the majority of 

the nutrient thresholds at 20 percent of the daily recommended value for the nutrient.

The MOH authorities also responded positively to U.S. comments with respect to other aspects of 

the regulations, confirming that 1) foods served in restaurants will not be subject to the labeling 

requirements; 2) existing commercial inventories will not be subject to the labeling requirements, 

and 3) food importers can comply with the law by using supplemental labels or stickers.

The United States is pleased with modifications Chile made to the initial labeling proposal but 

remains concerned that Chile has adopted a staggered implementation approach, as opposed to 

giving 18 months for compliance for all foods. Some foods must comply in only six months, 

contributing to higher food production costs by limiting time for label redesign and use of existing 

labeling stock. Consumers may also interpret the six-sided icon on the package as a stop sign that 

will discourage consumption even when the product is consumed in the context of an overall 

healthy diet and active lifestyle. The United States will continue to monitor the situation, especially 

the trade impact on imported prepackaged foods, and seek opportunities to work with Chile both 

bilaterally and in the WTO TBT Committee to address remaining concerns.

Printers –Safety and Energy Efficiency Labeling

In August 2012, Chile notified to the WTO measures concerning “Safety for Printers” and “Energy 

Efficiency for Printers.” These measures address safety and standby energy efficiency labeling for 

printers and require printers to be certified by a third party laboratory in Chile in order to be sold in 

Chile. Chile postponed the effective date to March 27, 2014, for the safety protocol and June 27, 

2014, for the energy efficiency protocol. In December 2013, Chile also noted its intention to 

measure sleep versus standby mode for the energy efficiency protocol. 

It is unclear what will happen to existing inventory already in the marketplace that do not meet 

these requirements. Also, U.S. industry will need additional time to come into compliance; U.S. 

industry believes that implementation needs to be delayed at least one year after Chile finalizes the 

measures. U.S. industry is also concerned that Chile did not take its comments into account. U.S. 
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industry submitted comments in October 2012, and did not receive a reply until April 2013, well 

after the comment period was over. The United States raised this issue both bilaterally and 

multilaterally on the floor of the WTO TBT Committee in 2013, and will continue to engage with 

Chile in 2014 to ensure that these requirements do not impose undue burdens on U.S. exports.

Electrical Labeling, Testing and Certification Requirements 

In August 2013, Chile notified to the WTO a draft Decree 298-2005, titled “Adoption of the 

certification regulations for electrical products and fuel products.” The draft measure sets stringent 

requirements for labeling, testing and certifying products covered by the decree. Only three 

laboratories have been approved to certify products. The requirement for testing and certifying

printers appears duplicative given other measures Chile maintains that already require testing and 

certification of printers (see previous entry). In addition, U.S. industry considers the labeling of 

each product with specific certification numbers and QR Codes as required under the decree to be 

especially burdensome. Chile stated that it would analyze comments through December 2013 and 

expects the decree to become effective in August 2014. In November, 2013, Chile put a hold on the 

process to revise Decree 298 in order to receive additional input and allow participation from 

stakeholders. The United States raised this issue both bilaterally and multilaterally on the floor of 

the WTO TBT Committee in 2013, and will continue to engage with Chile in 2014 to avoid 

unnecessarily burdensome labeling requirements.

China

Bilateral Engagement

In addition to discussing TBT issues in the WTO TBT Committee, the United States and China 

regularly engage on TBT related issues through the United States – China Joint Commission on 

Commerce and Trade (JCCT) and bilaterally on a case by case basis as specific market access 

issues arise. The JCCT, which was established in 1983, is the main forum for addressing bilateral 

trade matters and promoting commercial opportunities between the United States and China. The 

JCCT has played a key role in helping to resolve bilateral TBT issues, including those related to 

medical device recalls and registration, certification of information technology products, and cotton 

registration requirements.

China Compulsory Certification Requirements – Conformity Assessment Procedures

China’s Certification and Accreditation Administration (CNCA) requires a single safety mark – the 

China Compulsory Certification (CCC) mark – to be used for both Chinese and foreign products. 

U.S. companies continue to report, however, that China is applying the CCC mark requirements 

inconsistently and that many Chinese produced goods continue to be sold without the mark. In 

addition, U.S. companies in some sectors continue to express concerns about duplication of safety 

certification requirements, particularly for radio and telecommunications equipment, medical 

equipment, and automobiles.
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To date, China has authorized 152 Chinese labs to perform safety tests and accredited 13 Chinese 

certification bodies to certify products as qualifying for the CCC mark, as reported in the 2012 

USTR Report to Congress on China. When it joined the WTO, China committed to provide 

nondiscriminatory treatment to majority foreign owned conformity assessment bodies seeking to 

operate in China. China rejected suggestions that it recognize laboratories that have been accredited 

by ILAC MRA signatories or develop other procedures to recognize foreign conformity assessment 

bodies. It insists that it will accept conformity assessment bodies domiciled abroad only if the 

governments of ILAC MRA signatories negotiate MRAs with China. Moreover, China has not 

developed any alternative, less trade restrictive approaches to third party certification, such as 

recognition of a supplier’s self-certification.

Because China requires testing for a wide range of products, and all such testing for the CCC mark 

must be conducted in China, U.S. exporters are often required to submit their products to Chinese 

laboratories for tests that may be unwarranted or have already been performed abroad. This results 

in greater expense and a longer time to market. In addition, China has limitations on foreign

invested conformity assessment bodies in country.

The United States has repeatedly raised its concerns about the CCC mark system and China’s 

restrictions on foreign invested conformity assessment bodies with China both bilaterally and 

during WTO TBT Committee meetings. At the December 2012 JCCT meeting, China confirmed 

that eligible foreign invested testing and certification entities registered in China can participate in 

CCC mark related work and that China’s review of applications from foreign invested entities will 

use the same criteria as those applicable to Chinese domestic entities. In 2013, the United States 

pressed China to take action to implement its 2012 announcement that foreign invested entities are 

permitted in this sector. At the December 2013 JCCT meeting, China committed that, beginning in 

spring 2014, it will use the same conditions that are applicable to domestic entities when reviewing 

applications from foreign invested entities registered in China to be designated as CCC mark testing 

and certification organizations.

The United States will continue to press China on treating foreign invested entities equally with 

domestic entities in 2014.

Mobile Devices – WAPI Encryption Standards

The United States continues to have serious concerns regarding China’s 2009 unpublished 

requirement that its WAPI wireless local area networks (WLAN) standard be used in mobile 

handsets, despite the growing commercial success of computer products in China that comply with 

the internationally recognized WiFi standard developed by the Institute of Electrical and Electronics 

Engineers .

In 2013, Ministry of Industry and Information Technology (MIIT) remained unwilling to approve 

any Internet enabled mobile handsets or similar handheld wireless devices unless the devices were 

WAPI enabled. The United States continued to raise concerns with this requirement, both 
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bilaterally and in WTO TBT Committee meetings. The United States will vigorously pursue a 

resolution of this issue in 2014.

Mobile Devices – Draft Regulatory Framework 

MIIT issued the “Draft Mobile Smart Terminal Administrative Measure” on April 10, 2012. The 

draft measure proposed to establish a new regulatory framework for the mobile device market. The 

United States raised concerns about the draft measure with China in April and May 2012. The 

United States expressed concern that the measure would impose numerous new obligations, 

technical mandates, and testing requirements on information technology and telecommunications 

hardware, operating systems, applications, app stores, and other related services, and that the scope 

and mandatory nature of these requirements appeared unprecedented among the major global 

markets for mobile smart devices.

On June 1, 2012, MIIT published the draft measure on its website, soliciting public comment for 30 

days. In addition, in November 2012, China notified the draft measure to the WTO TBT 

Committee and indicated that it would accept comments for a 60 day period. Both the United States 

and affected industry submitted written comments on the measure. The United States and U.S. 

industry are concerned that the top down government mandated requirements contained in the 

measure are overly burdensome and could create significant trade barriers. Furthermore, the United 

States and U.S. industry are concerned that including numerous voluntary standards and testing 

requirements relating to smart terminals in the measure could create additional trade barriers if these 

voluntary standards become mandatory through MIIT’s testing and certification process. At the 

December 2012 JCCT meeting, China confirmed that it would take all stakeholder views into full 

consideration in regard to regulating information technology and telecommunications hardware, 

operating systems, applications, app stores, and other related services. In November 2013, MIIT 

finalized and implemented the measure, along with two associated voluntary standards that did not 

take stakeholder views into account. In 2014, the United States will closely monitor developments 

regarding this measure and any trade barriers associated with China’s regulation of information 

technology and telecommunications hardware, operating systems, applications, app stores, and 

other related services. 

4G Telecommunications - ZUC Encryption Algorithm Standard

At the end of 2011 and into 2012, China unveiled an encryption algorithm (known as the ZUC 

standard), which was developed by a quasi-governmental Chinese research institute for use in 4G 

Long Term Evolution (LTE). The European Telecommunication Standards Institute 3rd 

Generation Partnership Project had approved ZUC as one of three voluntary encryption standards 

in September 2011. According to U.S. industry reports, MIIT, in concert with the State Encryption 

Management Bureau , informally announced in early 2012 that only domestically developed 

encryption algorithms, such as ZUC, would be allowed for use in the network equipment (mobile 

base stations) and mobile devices comprising 4G TD-LTE networks in China. In addition, industry 

analysis of two draft ZUC related standards published by MIIT suggests that burdensome and 
59

invasive testing procedures threatening companies’ sensitive intellectual property could be required. 

The United States urged China not to mandate any particular encryption standard for 4G LTE 

telecommunications equipment used on commercial networks, in line with its bilateral 

commitments and the global practice of allowing commercial telecommunications service providers 

to work with equipment vendors to determine which security standards to incorporate into their 

networks. The United States stated that any mandate to use a domestic encryption standard such as 

ZUC would appear to contravene a commitment that China made to its trading partners in 2000 

stating that China would permit the use of foreign encryption standards in IT and 

telecommunication hardware and software for commercial use and that it would only impose strict 

“Chinese-only” encryption requirements on specialized IT products whose “core function” is 

encryption. Additionally, a ZUC mandate would appear inconsistent with China’s 2010 JCCT 

commitment on technology neutrality. In 2010, China had agreed to take an open and transparent 

approach that allowed commercial telecommunication operators to choose which 

telecommunications equipment and encryption technologies and standards to use for their networks 

and not to provide preferential treatment to domestically produced standards or technology used in 

3G or successor networks, so that operators could choose freely among whatever existing or new 

technologies might emerge to provide upgraded or advanced services.

The United States pressed China on this issue throughout the run up to the December 2012 JCCT 

meeting. At that meeting, China agreed that it will not mandate any particular encryption standard 

for commercial 4G LTE telecommunications equipment. In 2013, the United States worked to 

ensure that MIIT’s voluntary testing and approval process for the ZUC 4G telecommunications

equipment standards fully protected applicants’ intellectual property by not requiring source code or 

other sensitive business confidential information to be provided during the approval process. At the 

December 2013 JCCT meeting, China committed that it will not require applicants to divulge 

source code or other sensitive business information in order to comply with the ZUC provisions in 

the MIIT application process for 4G devices. In 2014, the United States will closely monitor 

developments in this area.

IT Products – Multi-Level Protection Scheme

Beginning in 2010 and continuing through 2013, both bilaterally and during WTO TBT Committee

meetings, the United States has raised concerns with China about its framework regulations for 

information security in critical infrastructure, known as the Multi-Level Protection Scheme 

(MLPS), issued in June 2007 by the Ministry of Public Security and MIIT. The MLPS regulations 

put in place guidelines to categorize information systems according to the extent of damage a 

breach in the system could pose to social order, the public interest, and national security. The 

MLPS regulations also appear to require buyers to comply with certain information security and 

encryption requirements that are referenced in the MLPS regulations.

MLPS regulations bar Chinese information systems graded level three and above from 

incorporating foreign products (China grades an information system with respect to its handling of 
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national security information, with the most sensitive systems designated as level five). Systems 

labeled as grade level three 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 three and above must 

disclose product source codes, encryption keys, and other confidential business information. To 

date, government agencies, firms in China’s financial sector, Chinese telecommunications 

companies, Chinese companies operating the domestic power grid, educational institutions, and 

hospitals in China have issued hundreds of request for proposals (RFPs) incorporating MLPS 

requirements. These RFPs cover a wide range of information security software and hardware. By 

incorporating level three requirements, many RFPs rule out the purchase of foreign products.

Currently, China applies the MLPS regulations only in the context of these RFPs. If China issues 

implementing rules for the MLPS regulations to apply the rules broadly to commercial sector 

networks and IT infrastructure, those rules could adversely affect sales by U.S. information security 

technology providers in China. The United States urged China to notify the WTO of any MLPS 

implementing rules regarding equipment related requirements. At the December 2012 JCCT 

meeting, China indicated that it would begin the process of revising the MLPS regulations. It also 

agreed to discuss concerns raised by the United States during the revision process. Throughout 

2013, using the JCCT process, the United States pressed China to fully and quickly implement its 

JCCT commitment to revise the MLPS regulations. In mid-2013, China indicated that it is working 

on revising the regulations. However, to date, China has not yet issued them. The United States 

will continue to urge China to refrain from adopting any measures that mandate information 

security testing and certification for commercial products or that condition the receipt of 

government preferences on where intellectual property is owned or developed. 

Medical Devices – Conformity Assessment Procedures

The United States has expressed concerns over the past years regarding China’s medical device 

registration requirements. The Legislative Affairs Office of the State Council has considered 

amendments to Order 276 “Regulation on Supervision and Administration of Medical Devices” and 

it released significant revisions in 2007, 2010, and in 2012. China has not notified these 

amendments to the WTO.

The most recent 2012 revision (third draft) of Order 276 continues to mandate country of origin 

registration, a requirement that prevents foreign manufacturers of medical devices from registering 

their products in China without prior marketing approval in the country of origin or country of legal 

manufacture. According to U.S. industry, this requirement has blocked or inordinately delayed 

sales of safe, high quality medical devices to the Chinese market because some manufacturers did 

not apply for marketing approval for certain products in the countries in which they were produced 

or in their home countries for reasons unconnected with product quality or safety. For example, 

producers may design particular medical devices specifically for patients in a third country, such as 

China, or may choose to produce them in a third country for export only. In these situations, a 

manufacturer would have no business reason to seek to have a particular device approved in its 
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home country or the country of export and would likely forego that process to avoid the associated 

burdens of time and money. China continues to defend this requirement despite concerted efforts to 

resolve this issue. 

The most recent version (third draft) of Order 276 also continue to reflect: (1) problematic product 

type testing (or “sample testing”) requirements; (2) a burdensome reregistration process; and (3) the 

requirement that clinical trials be repeated in China in order to register products there. U.S. 

industry continues to advocate for the transition from end product type testing to a quality 

management system approach, as outlined in ISO standard 13485. Furthermore, while the latest 

draft increases the validity of a registration from four to five years, China’s reregistration process 

continues to require fees and submissions comparable to the initial registration process.

With respect to the issue of in country clinical trials, at the 2010 JCCT Subgroup meeting, China’s 

State Food and Drug Administration (SFDA) committed that China would accept clinical evidence 

from outside China and that China would not automatically mandate in country clinical trials for 

Class II and Class III devices. However, the latest revision of Order 276 proposed a waiver of in

country clinical trials for Class I (lowest risk) devices only and the availability of clinical trial 

waivers for Class II and Class III devices remains unclear. In bilateral discussions with China in 

2012, the United States urged China to meet with stakeholders to discuss their concerns. In 2013, 

the United States raised the issue with China in the WTO TBT Committee, and it will continue to 

monitor the development of revisions to Order 276 in 2014.

Imaging and Diagnostic Medical Equipment – Classification 

Another source of concern relates to China’s classification of imaging and diagnostic medical 

equipment. China classifies most imaging and diagnostic medical equipment as Class III. This 

classification represents the highest risk and therefore it is the most stringent classification for 

medical devices. This classification is problematic because it deviates from international practices 

and burdens manufacturers with additional requirements, such as conducting expensive and 

potentially unnecessary domestic clinical trials.

During the 2011 JCCT meeting, the United States urged China to place certain imaging and 

diagnostic medical equipment into a lower risk category. China’s SFDA committed to issue, by 

June 2012, a complete list of x-ray equipment to be placed in a lower risk category and agreed to 

endeavor to release a draft for an in vitro (e.g., test tube) diagnostic equipment catalog for public 

comment by June 2012. Subsequently, in August 2012, SFDA revised and lowered the 

classification for four subcategories of imaging and diagnostic medical equipment under the 

“Classification Catalogue of Medical Devices,” including certain medical ultrasonic instruments 

and related equipment, medical x-ray equipment, medical x-ray ancillary equipment and 

components, and medical radiation protective equipment and devices. The United States raised the 

issue of reclassifying additional products with China in 2013 in the WTO TBT Committee, and it 

will continue to monitor developments in 2014.
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Patents Used in Chinese National Standards

In the State Council’s Outline for the National Medium to Long-Term Science and Technology 

Development Plan (2006-2020) and in the 11th Five Year Plan (2006-2010) for Standardization 

Development of the Standardization Administration of China (SAC), China prioritized the 

development of national standards.

In November 2009, SAC circulated for public comment proposed “Provisional Rules Regarding 

Administration of the Establishment and Revision of National Standards Involving Patents.” The 

provisional rules indicated that in principle a mandatory national standard should not incorporate 

patented technologies. The draft provisional rules also indicated that, when the use of patented 

technologies was needed, a compulsory license could result if the relevant government entity was 

unable to reach agreement with the patent holder. The United States provided comments opposing 

this and other aspects of the draft provisional rules, which did not take effect. In December 2012, 

SAC circulated new draft interim measures, omitting certain troubling aspects of the earlier draft, 

such as the compulsory license provision, but raising other concerns, including in its definition of 

the responsibilities and potential liabilities of individuals and organizations that participate in the 

formulation of revision of national standards. In early 2013, the United States provided comments 

to SAC on these and other concerns. In December 2013, China issued its interim rules. The United 

States is reviewing the interim rules and will continue to engage with China on this issue in 2014.

Cosmetics –Approval Procedures and Labeling Requirements

SFDA initiated a series of changes to China’s cosmetics regulation after obtaining jurisdiction over 

the industry in 2008. SFDA imposed additional requirements on “new ingredients” in April 2010, 

and issued guidance on the application and evaluation of new cosmetic ingredients in 2011. These 

actions stalled the approval of cosmetics containing new ingredients. In fact, SFDA has approved 

only a handful of new ingredients since 2010. The United States, along with EU and Japan, 

continue to raise concerns regarding the application requirements at WTO TBT Committee

meetings.

In December 2012, China notified “Cosmetics Label Instructions Regulations” and “Guidance for 

the Cosmetics Label Instructions,” which propose new labeling requirements that are in addition to 

the two existing labeling requirements that apply to cosmetic products. In January 2013, U.S. 

industry submitted comments through the U.S. TBT Inquiry Point, arguing that the proposed 

regulation overlaps and conflicts with existing Chinese regulations, and creates an undue burden for 

the industry. 

The United States is also monitoring possible implications of SFDA’s efforts to create an inventory 

of “existing ingredients” that have been approved for use in cosmetics products in China. In 

September 2012, SFDA released for comment the “SFDA Notification: List of Raw Materials 

Already in Use in Cosmetics (Third Batch).” It released the first and second lists of materials in 

April and July 2012, respectively.
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In 2014, the United States will urge China to continue dialogue with all interested parties regarding 

these measures and to take into account the comments received. China should also consider 

alternative measures that are more commensurate with the risks involved, such as post market 

surveillance and reliance on internationally recognized good manufacturing practices (GMPs). 

These alternatives could meet China's legitimate regulatory objectives with fewer disruptive effects 

on international trade.

Colombia

Bilateral Engagement

The United States discussed TBT matters with Colombia during and on the margins of WTO TBT 

Committee meetings, and in the TBT Chapter Committee of the United States – Colombia Trade 

Promotion Agreement. The second meeting of the TBT Chapter Committee will be scheduled in 

spring 2014.

Commercial Vehicles – Diesel Emission Standards

As raised in prior TBT Reports, the United States remains concerned about the Ministry of the 

Environment and Sustainable Development’s draft resolution amending Resolution No. 910 of 

2008, which has now been renamed Resolution 1111. On December 14, 2012, Colombia notified 

this proposed measure to the WTO. Resolution No. 1111 is proposed to go into effect on January 1, 

2015, fifteen months later than the initial implementation date. This resolution states that the 

current commercial vehicles emission standards in Colombia, EPA 98 (a U.S. standard) and EURO 

III (an EU standard), will no longer be valid for new commercial vehicles seeking registration for 

sale in Colombia. Furthermore, this resolution states that EPA 04 and EURO IV emission standards 

will only be accepted for long haul semitrailers until December 2014. The draft resolution provides 

that by January 2015, all commercial vehicles seeking registration for sale in Colombia must meet 

EURO IV emission standard requirements. Given the design of some U.S. manufactured diesel 

truck engines, U.S. industry has expressed concern that using this EU standard would effectively 

exclude many U.S. heavy duty trucks from the Colombian market. Further, according to EcoPetrol, 

the Colombian state-run oil company, the fuel necessary to comply with the new standard will not 

be available nationwide until 2017. Additionally, U.S. manufactured diesel truck engines that meet 

the U.S. EPA 04 standard, which is more stringent than the EURO IV standard, already face 

restricted access to the Colombian market, because Colombia does not maintain adequate supplies 

of the high quality fuel needed for these high technology engines. 

In 2013, the United States, and other concerned WTO Members, including Japan, Mexico and 

Canada, raised these issues during the March and June 2013 WTO TBT Committee meetings.

The United States will continue to monitor this issue in 2014, as manufacturers begin to implement 

Resolution No. 1111.
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Certificates of Free Sale

In April 2013, U.S. processed food manufacturers began to voice concerns with Colombia’s 

duplicative certification regulations, which require the provision of a Certificate of Free Sale for 

each imported product both at the time of registration and on a shipment by shipment basis as 

imports are received. As the United States worked with Colombia’s National Institute of Food and 

Drug Monitoring (INVIMA) to relax these requirements, INVIMA revised requirements in Circular 

(#400-1239-13), but did not notify the WTO of its revisions, to indicate that future Certificates of 

Free Sale must include additional language to which no U.S. Federal agency will attest.

After receiving an overwhelming number of complaints from global trading partners, in August 

2013 INVIMA rescinded the requirement to include additional language in the Certificates of Free 

Sale in another Circular (#400-1846-13), which was also not notified to the WTO. Although 

through the rescinding of this requirement, Colombia prevented what could have resulted in 

effectively stopping the flow of U.S. processed food product trade, concern remains that U.S. 

exporters of processed food products continue to be required to provide Certificates of Free Sale at 

multiple stages of the export process. U.S. exporters complain that the costs associated with 

obtaining multiple certificates is problematic, and that they often are unable to obtain the requested 

Certificates of Free Sale in time for the shipments due to a lack of resources in the agencies tasked 

with providing these certificates. The United States plans to continue engagement with Colombia 

on this issue in 2014.

Ecuador

The United States discusses TBT matters with Ecuador during and on the margins of the WTO TBT 

Committee meetings and bilaterally.

Resolution 116 - Product Certificate

In 2013, Ecuador enacted technical regulations for numerous products, including food products, 

cosmetics, spices, toys, and building materials. It appears some of these technical regulations, 

although notified to the WTO, went into force without an adequate amount of time for interested 

parties to provide comments. Establishing compliance with the criteria specified in these various 

relevant technical regulations is a condition for importation or sale of these products in Ecuador.

Ecuador’s Foreign Trade Committee issued Resolution 116 on December 4, 2013. This resolution

applies to 300 products and sets out requirements to demonstrate compliance with the various 

technical regulations. Resolution 116 was not notified to the WTO before it went into force. 

Resolution 116 requires commercial entities to obtain a Certificate of Recognition to demonstrate 

that their products conform to the criteria in the various technical regulations. The certificate of 

recognition can only come from a body certified by the Ecuadorian Accreditation Organization –

which to date have only been Ecuadorian bodies. Besides the burden from not being able to obtain 

a certificate from bodies in the exporter’s home country, the authorized Ecuadorian bodies appear to 
65

lack sufficient capacity to fulfill the demand for the certificates. As a result, exports to Ecuador are

declining sharply. It also appears goods already exported to Ecuador are having difficulty clearing 

customs.

Stakeholders have raised concerns that Resolution 116 and the various technical regulations may be 

intended to address Ecuador’s trade balance rather than address legitimate health or safety concerns. 

Certain Ecuadorean government officials have been reported as stating that these measures are part 

of a policy of import substitution.

U.S. Federal agencies have been closely following these developments and have been engaging 

with their Ecuadorean counterparts. In addition, USTR has raised it serious concerns with 

Resolution 116 and the various technical regulations with senior Ecuadorian officials. The United 

States intends to continue to raises these concerns with Ecuador in 2014, both bilaterally and in the 

WTO TBT Committee. 

Processed Foods – Nutritional Labeling Requirements 

On November 29, 2013, an agency in Ecuador’s Ministry of Health, the National Agency of 

Regulation, Control and Sanitary Surveillance, published Executive Decree No. 4522. The decree 

applies to various processed food products and requires the products to be sold with particular 

labeling as set out in an Ecuadorean technical regulation, RTE-INEN-022. In particular, 

prepackaged foods that contain sugar, salt, and fat must have mandatory front of pack labeling. 

Additionally, an icon, which takes up about 1/6th of the container or package, will be required, with 

a bar that will reflect low, medium, or high nutrient content by each 100 grams in the food for salt, 

sugar, and fat. Such symbols are commonly referred to as traffic light symbols. For foods that are 

smaller than 14.4 cm, that have high levels of fat, sugar or sodium, the icon is not required, but an 

advisory message is required, “For your health, reduce the consumption of this product.” An 

advisory statement is also required for foods that contain less than 50 percent “natural” content in 

them. Ecuador defines a “natural food” as “a food as presented in nature that has not been 

transformed.” The decree also states that there are no costs to implement the new labeling

requirements. Producers of the affected products have one year to comply with the new 

requirements.

According to RTE-INEN-022, any nutritional labeling requires laboratory testing to confirm the 

nutrient content of processed products. Initial reports are that the new labeling will not trigger the 

need for exporters to reapply for a Sanitary Registration from the Ecuadorean government, a 

process than could be potentially costly and burdensome, as it requires additional laboratory testing 

to confirm the ingredients and labels of the food products.

The United States requested that Ecuador notify its proposed amendment to the WTO on March 26, 

2013. No draft has yet been notified to the WTO. Ecuador has argued the decree is a Ministerial 

Amendment and therefore not subject to WTO notification. The United States considers this 

change to be an amendment to a technical regulation that should be notified to the WTO.
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In 2014 the United States will continue to follow this issue closely. In particular, the United States 

will press to ensure Ecuador maintains a transparent process that allows for consideration of 

comments from stakeholders at an early and appropriate stage and to clarify that Sanitary 

Registration will not be required as part of any new labeling regime if manufacturers have made no 

other changes to the food product.

Mandatory Labeling of Foods Derived From Biotechnology

On October 15, 2013, Ecuador published an amendment to Technical Regulation RTE INEN 022 

“Labeling of Processed, Packed, and Packaged Food Products” which indicates that beginning May 

15, 2014, mandatory labeling of “contains transgenics” will be enforced. The U.S. industry is 

concerned that imposing mandatory requirements to label food and beverage products with the 

statement “contains transgenics” will negatively impact bilateral trade. For foods derived from 

genetically engineered organisms that have been found to be substantially equivalent to 

conventional counterparts, mandating “contains transgenics” labeling may create an erroneous 

impression that the product is less safe than conventional products.

The United States has engaged bilaterally with Ecuador on this issue including at the sidelines of 

the WTO TBT Committee meeting in October 2013 and will continue to raise this issue in 2014. 

On February 20, 2014 the United States submitted comments requesting a clear definition of 

“contains transgenics.” The United States requested clarification of the manner by which “testing 

for access to compliance,” and “demonstration of compliance” will be carried out with regards to 

mandatory transgenics labeling. The United States will in particular monitor the development of 

implementing regulations that are being drafted by Ecuador’s government agencies.

European Union

Bilateral Engagement

The United States and the EU engage on TBT-related matters in various fora, including the TBT 

Committee, the Transatlantic Economic Council (TEC) and the United States – European Union 

High-Level Regulatory Cooperation Forum (HLRCF). This engagement aims to minimize 

unnecessary barriers to U.S.-EU trade. It also aims 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.

The launch of negotiations for a T-TIP Agreement – a comprehensive trade and investment 

agreement – is providing new opportunities to address TBT-related issues with the EU. In addition 

to developing disciplines that build upon WTO TBT obligations to further prevent and eliminate 

unnecessary obstacles to trade, the negotiations provide the United States and the EU a regular 

opportunity to meet to seek to resolve specific trade concerns. See Section IX for details on T-TIP.

Semiconductors and Refrigeration Appliances — Regulation on Fluorinated 
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Greenhouse Gases (F-Gas)

The EU notified its proposed changes to its regulation (No. 842/2006) on fluorinated greenhouse 

gases (F-Gas) on February 7, 2013 as G/TBT/N/EU/91. The European Commission had already 

transmitted its proposal to the European Parliament and European Council before notifying WTO 

Members. Consistent with President Obama’s Climate Action Plan regarding U.S. leadership on 

global efforts to phase down the consumption and production of climate damaging HFCs, the 

United States strongly supports the objectives of the EU’s proposed regulation, including its

proposed approach that combines both a phase down of hydrofluorocarbons (HFCs) and specific 

appliance bans. However, a particular ban contained in the proposed measure raised concerns for 

some U.S. household refrigerator manufacturers. Indeed, several U.S., Korean, and Japanese 

industry commenters on the proposed regulation raised concerns with particular product bans, tight 

timelines for implementation and the unwillingness of the EU to meet with some impacted 

industries.

The specific concern among household refrigerator appliance manufacturers was the EU’s proposed 

change to its F-gas regulations to ban the use of HFCs with global warming potential (GWP) of 150 

or more in residential refrigerators and freezers on January 1, 2015. While the U.S. appliance 

industry does not oppose the reduction of HFC use – indeed many companies have already adopted 

alternative substances – it does oppose particular product specific regulations and the aggressive 

2015 timeline for implementation with respect to household refrigerators and freezers. Specifically, 

the U.S. appliance industry commenters cited significant and expensive changes to manufacturing 

processes necessary to produce goods compatible with hydrocarbon refrigerants for a few 

companies, including some U.S. SMEs, that had not yet adopted the alternative substances taken up 

by others (e.g., more than 50 percent of current new production globally uses hydrocarbons (HC600a)).

The EU’s own impact assessment recommended against a ban on HFCs in domestic (residential) 

refrigeration because of its low effectiveness towards reducing GHG emissions, stating that “a strict 

regulatory instrument such as a ban would need to be justified with a substantial contribution to the 

EU’s emission reduction targets.” However, the EU decided to include this ban. Additionally, the 

U.S. appliance industry was extremely concerned with the lack of its ability to participate in the 

development of this proposal beyond a single public meeting. Specifically, the appliance industry 

stated that DG Climate Action rebuffed several of its attempts to discuss the EU’s proposal. 

Further, as noted above, the Commission had already transmitted its proposed regulation to the 

European Parliament and European Council, before notifying WTO Members, and therefore the 

Commission would not take Members’ comment into account by revising its proposed regulation. 

U.S. semiconductor manufacturers stated that they have eliminated noncritical usage of HFC, but no 

alternative input can be used for certain production processes. In their view, the proposed HFC 

phasedown to 20 percent of their baseline will negatively affect semiconductor production in the 

industry in significant ways. Because of the semiconductor industry’s technical requirements 

related to use of fluorine in manufacturing (the fluorine atom’s stability is critical to get precise 
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manufacturing, and has specific chemical properties and functionalities that are critical to five to six

phases of the semiconductor production process), it sought an exemption for this specific use, so 

that it could maintain production. Further, the semiconductor industry is an insignificant player in 

terms of absolute emissions of F-gas, emitting less than 0.05 percent of total EU HFC emissions in 

recent years. Additionally, it is difficult to predict what types of HFCs will be required by the 

semiconductor industry, since technology quickly changes year to year and the type of F-gas needed 

depends on the product being manufactured. The total share of semiconductor production capacity 

located in Europe that is owned by U.S. headquartered firms is approximately 41 percent.

The United States raised these concerns at the WTO TBT Committee in June and October 2013, as 

well as bilaterally with the EU in December 2013. In January 2014, the European Parliament and 

Council reported the final text of the F-Gas regulation and repealed Regulation (EC) No 842/2006. 

The final regulation exempted semiconductor production, addressing the concerns that United 

States and the industry had raised with respect to semiconductors, but maintained the January 1, 

2015 deadline on HFCs in residential refrigerators and freezers that will result in a ban on products 

from U.S. companies unless or until they transition their production lines over to an alternative 

refrigerants with a GWP 150 or less. Formal adoption of the legislation by the European Parliament 

is expected in the coming month.

Proposal for Categorization of Compounds as Endocrine Disruptors

Endocrine disruptors (EDs) are naturally occurring compounds or man-made substances that may 

mimic or interfere with the function of hormones in the body. When available in the environment, 

potential endocrine disruptors may turn on, shut off, or modify hormone activity, leading to adverse 

impacts on the normal functions of tissues and organs. Under existing EU legislation on chemicals, 

pesticides, and other products, the Commission was to develop measures related to EDs by the end 

of 2013. DG Environment is charged with developing the approach for regulating EDs and opted to 

follow an approach based on categorization; under which hazard based “cut-off criteria” would be 

established to determine products that could be removed from the market. The 2013 deadline was 

not met, and the EU now plans to conduct an impact assessment to evaluate a range of options for 

ED related measures, including the use of hazard based cutoff criteria, for inclusion in amendments 

to EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the EU 

Biocides Directive and the Plant Protection legislation.

In early November 2012, DG Environment released an initial proposal for the definition, 

identification, and categorization of EDs. Although this approach was intended to be applied first 

to EU Plant Protection Product regulations, the DG Environment proposal, if implemented, would 

later be applied to other EU regulatory programs, including REACH. The initial set of categories 

developed in November 2012 by DG Environment included four categories – Known EDs, 

Presumed EDs, Suspected EDs and Potential EDs – which it narrowed down to two categories in 

February 2013 – Known EDs and Suspected EDs. DG Environment circulated a document 

containing its initial set of categories to a variety of stakeholders including NGO’s, industry, and 

the U.S Environmental Protection Agency (U.S. EPA) for comment.
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U.S. industry, particularly the chemical and crop protection sectors, submitted comments opposing 

the hazard based categorization or cutoff criteria approach, which excludes relevant and 

internationally accepted scientific and toxicological criteria including (1) potency, (2) exposure, (3) 

lead toxicity, (4) severity, and (5) irreversibility. In addition, U.S. industry requested DG 

Environment to consider language in EU Regulation 1107/2009 that would not require a category

based approach, and to reflect in its proposal “scientific criteria for the determination of endocrine 

disrupting properties.” U.S. EPA participated in DG Environment’s informal public consultations 

by providing technical comments on the November proposal.

U.S. EPA comments detailed the science based approach of its Endocrine Disruptor Screening 

Program (EDSP) for characterizing chemical availability, activity, and adversity relevant to possible 

endocrine disruptors. The U.S EPA’s EDSP is screening and testing substances for availability and 

activity, before determining if further evidence is needed to determine if the weight of evidence 

indicates endocrine mediated adversity. The U.S. EPA bases its registration requirements on 

decisions on registration or reregistration with a risk based approach taking into account availability 

and exposure, as well as activity and hazard. Under DG Environment’s proposal, a substance could 

be deregistered if it is assigned to a category that meets the (activity) cutoff, without considering 

real world risk and evaluating the weight of evidence indicating adversity. Chemical and crop 

protection industries are very concerned that a large number of substances will be affected by the 

new categories and withdrawn from the EU market as a result.

Industry is concerned because categorization and development of lists of chemicals according to 

categories such as “suspected EDs” based purely on availability and activity would likely 

precipitate decisions to stop using those products or promote the switch to alternatives whose health 

effects may be less well understood, without any scientific demonstration that the products cause 

harm. In addition, the decisions could have the effect of denying access to useful products and 

technologies and expose the public to unknown or potentially more serious risks. Further, the 

proposal provides no specific criteria to evaluate data sets to determine what the specific properties 

are, what responses would qualify, what methods should be used to assure scientific validity, or 

what magnitude of effects would be needed to meet these terms.

DG Environment had intended to finalize its hazard criteria for all EDs by the end of 2013. DG 

Health and Consumers is responsible for plant protection materials and was to develop criteria for 

those products. It requested an evaluation of the hazards of EDs from the European Food Safety 

Authority (EFSA), which published its “Scientific Opinion on the hazard assessment of endocrine 

disruptors” with specific attention given to food safety in March 2013. EFSA concluded that “EDs 

can therefore be treated like most other substances of concern for human health and the 

environment, i.e., are subject to risk assessment and not only to hazard assessment.” DG 

Environment cited inconsistencies in the EFSA report, but nonetheless believes that the EU’s 

approach to ED hazard identification is consistent with EFSA recommendations.

In mid-2013, the Commission’s Secretary General’s office determined that the regulatory changes 

planned by DG Environment necessitated an impact assessment, including an opportunity for public 
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consultation. Impact assessments that have been conducted by independent organizations suggest

significant trade impacts from an approach based only on hazard criteria. The need for an impact 

assessment was reinforced by an open letter written to the Chief Scientific Officer to the President 

of the European Commission, by 71 renowned European toxicologists. The letter urged the 

Commission to reconsider its regulatory approach to EDs which would be taken “without adequate 

scientific evidence,” and “would reverse current scientific and regulatory practices.” The 

Commission is expected to publish a roadmap in early spring 2014 which will provide a framework 

for conducting the impact assessment. While it is not clear whether or not the roadmap will be 

notified through the WTO, the Commission has indicated that it will provide a notice and comment 

period of 60 days on the roadmap.

In 2013, the United States raised concerns with DG Environment’s proposal on the categorization 

of endocrine disruptors bilaterally, as well as in the WTO TBT and SPS Committees in June and 

October, and welcomed the decision to conduct an impact assessment on the plant and biological 

issue. The United States has emphasized the need for active public participation and transparency, 

including the opportunity for public comment on draft impact assessments, proposed regulatory 

actions and the supporting scientific opinions, and to have those comments taken into account in 

finalizing any measure. In 2014, the United States will closely monitor developments on this issue.

Chemicals – Registration, Evaluation, Authorization and Restriction of Chemicals 

The European Union regulation for the Registration, Evaluation and Authorization of Chemicals 

(REACH) began as a Communication from the Commission in 2001, “White Paper on Strategy for 

a future Chemicals Policy (REACH).” The European Parliament (Parliament) approved REACH 

and the Council of Ministers (Council) formally adopted it in December 2006. REACH entered 

into force on June 1, 2007, and will be fully implemented by 2015. REACH impacts virtually every 

industrial sector, from automobiles to textiles, because it regulates chemicals as a substance, in 

preparations, and in products. It imposes extensive registration, testing, and data requirements on 

tens of thousands of chemicals. REACH also subjects certain chemicals to an authorization process 

that would prohibit them from being placed on the EU market except as authorized for specific uses 

by the European Commission.

Concerns regarding REACH have been raised at every WTO TBT Committee meeting since 2003 

by the United States and many other delegations including Argentina, Australia, Botswana, Brazil, 

Canada, Chile, China, Chinese Taipei Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, 

Egypt, El Salvador, India, Indonesia, Israel, Japan, the Republic of Korea, Kuwait, Malaysia, 

Mexico, Pakistan, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, South Africa, 

Switzerland, Thailand, and Uruguay. Members have intervened with concerns that aspects of 

REACH are discriminatory, lack a legitimate rationale, and pose unnecessary obstacles to trade. 

Members have indicated the need for greater transparency in the development and implementation 

of REACH requirements, and frequently cite the need for further information and clarification, as 

well as problems producers have in understanding and complying with REACH’s extensive 

registration and safety data information requirements. The United States has also raised its 
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concerns regarding REACH directly with the EU and has worked with the European Chemicals 

Agency (ECHA) on specific technical issues.

In recent years, the United States has registered concerns in the WTO TBT Committee and 

bilaterally regarding inter alia the following requirements under REACH.

• Rules for manufacturers outside the EU to appoint “Only Representatives” (ORs): An OR is 

a natural or legal person established in the EU authorized to carry out the obligations that 

REACH imposes on importers. REACH bars U.S. producers from registering substances 

for use in the EU and thus 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.

• Data compensation issues in connection with the operation of Substance Information 

Exchange Forums (SIEFs): For each registered substance, REACH requires the formation of 

a SIEF. 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 varying interpretation of “article” across the EU Member states and European 

Chemicals Agency (ECHA): Under EU REACH, if a certain chemical (a substance of high 

concern, or SVHC) is present in an article at 0.1 percent or more in concentration in that 

article, then a manufacturer/importer must notify the ECHA. Different Member states have 

issued interpretations for how an “article” is defined at variance with ECHA’s definition. 

The Member state definition then determines the chemicals which need to be notified in that 

Member state – resulting in differences across Member states with which companies must 

track and comply. The Commission, and the majority of the Member states, views every 

article, including assembled ones, as a single article. U.S. industry supports that position. 

However, a number of Member states, including Germany, Austria, Belgium, France, 

Sweden, Denmark, and Norway, have rejected the ECHA’s interpretation through their

national rulemaking process.

• The treatment of monomers and polymers under REACH: 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 
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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.

The proliferation of nanomaterials registries across the EU Member states: Among the substances 

subject to REACH regulations are nanomaterials, or “chemical substances or materials that are 

manufactured and used at a very small scale (down to 10,000 times smaller than the diameter of a 

human hair),” which are used in products ranging from batteries to antibacterial clothing. The 

Commission is considering options to adapt the data requirements for nanomaterials in REACH 

registration dossiers. An impact assessment is expected to be completed in spring 2014, and the 

Commission plans to propose amendments to the Council and Parliament by May or June 2014. 

The Commission plans to notify WTO Members per normal procedures, i.e., after it puts forward its 

proposal for Co-Decision by the Council and Parliament.

Although REACH provides a standardized plan for reporting and registering nanoscale ingredients, 

several EU Member states have initiated the development of their own such registries, which often 

include exemptions for pigments and food additives. The Commission is preparing an impact 

assessment on transparency measures for nanomaterials, which will look at policy options to gather 

information on nanomaterials currently in the market, such as notification scheme or a registry. 

This would not necessarily be part of the REACH regulation. Plans are for the impact assessment 

to go to the Commission’s Impact Assessment Board for review in the fall 2014. Given the EU 

Member states’ access to REACH information on nanoscale ingredients, it is unclear how numerous 

national reporting schemes will help to deliver better knowledge or promote a more adequate and 

rapid response in the event of a specific risk being identified. Belgium, Denmark, France, and Italy 

either have instituted, or have announced plans to develop, a national registry. Industry questions 

the value that Member state level registries can bring, and expresses the following concerns: (1) the 

notification requirements in several Member states mandates submission of trade secrets or 

confidential business information; (2) variations in how Member states define a “nanomaterial” and 

its reporting requirements; (3) necessary time investment to understand and comply with the 

measures; (4) taxpayer expenditure in registry implementation; and (5) new administrative burdens.

• A lack of transparency and science based analysis associated with the Community Rolling 

Action Plan (CoRAP): The CoRAP is part of the REACH substance “evaluation” process. 

Its purpose is to allow EU Member states and ECHA to prioritize substances that are 

suspected of being hazardous to human health or the environment. Depending on the 

outcome of the evaluation, a substance evaluated under CoRAP may be considered for 

classification as a SVHC and become subject to authorization and restriction procedures. It 

is also possible that after evaluation, a substance will be found to not pose such a risk. 

ECHA has established criteria for selecting substances for placement on the list. These 

criteria address concerns about hazard, exposure, and tonnage. Member states are 

encouraged, but not obliged, to use the ECHA criteria and are empowered to evaluate the 
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substances on the CoRAP list. The most recent CoRAP list was approved by ECHA on 

March 20, 2013. It operates over a three year period and is updated every March. The 

current list contains 115 substances, which will be evaluated during the course of 2013, 

2014, and 2015. CORAP preliminary reports should be made available to interested U.S. 

companies, even if they have not yet registered the particular substance. Currently, the 

reports are only made available to registrants. More transparency on the part of the EU with 

respect to U.S. companies impacted by this regulation would reduce costs and address U.S. 

industry’s concerns regarding the responsiveness of some Member states to their domestic 

interests in the CoRAP process.

In 2013, the United States also raised concerns bilaterally with the EU on the lack of public notice 

and comment associated with the “Risk Management Options” (RMO) analysis phase of the SVHC 

Roadmap. Under the Commission’s Roadmap for evaluation of individual SVHCs, at the request of 

the Commission, a Member state Competent Authority or ECHA will conduct an RMO analysis to 

determine whether regulatory risk management is required for a given substance, and to identify the 

most appropriate regulatory instrument to address a concern. The regulatory decision may be to 

pursue authorization or restriction, address the concern via other legislation, or take no action. The 

Commission’s SVHC Roadmap identifies five minimum criteria for the RMO analysis and states 

that the RMO is not meant to be public. Beyond this, the authority drafting the RMO has discretion 

with respect to the level of detail provided in its analysis and whether or not consultation of 

stakeholders is appropriate. ECHA has said that documenting the RMO analysis and sharing it with 

other EU Member states and the Commission promotes early discussion and should ultimately lead 

to a common understanding on the regulatory action pursued. The United States supports the EU’s 

efforts to conduct RMO analysis, and believes the RMO analysis should be implemented in a 

harmonized and consistent manner by Member states. Further, regulatory decisions taken under 

this process carry the potential to significantly impact trade. To prevent or minimize potential 

adverse effects on trade, the RMO analysis should be subject to public notice and comment, with 

the views expressed by commenters taken into account by the Member state or ECHA irrespective 

of the domicile of the commenter.

Renewable Fuels -- Renewable Energy Directive

In April 2009, the EU adopted the RED (2009/28/EC), with the objective of helping lower its 

greenhouse gas emissions (GHG), reducing its dependence on foreign oil, and increasing rural 

development. The EU RED establishes mandatory national targets for the share of energy from 

renewable sources by 2020. It also establishes a methodology and accounting system by which EU 

Member states may record and calculate GHG savings as compared to a baseline for fossil 

fuels. According to the EU, this comparison quantifies the total amount of GHG savings in the EU 

and progress toward the EU’s overall goal of a 20 percent reduction in GHG emissions versus 1990 

levels by 2020. To count toward Member state specific renewable energy use targets, or benefit 

from incentives, the RED requires that biofuels and feedstocks for biofuels meet certain 

sustainability criteria. Combined with the Commission Communications 2010/C 160/01 and 
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2010/C 160/02 of June 2010, the RED also sets the reporting and verification requirements for 

obtaining sustainability certifications.

The United States and the EU agree that sustainable agricultural practices are a critical component 

in the expansion of food production needed in the future. However, we have expressed concerns 

both bilaterally and in the WTO that the RED, and its paperwork and verification requirements, is 

disrupting trade in U.S. products (specifically soybeans used as biofuel feedstock). Under Article 

18(4) of the RED, which provides for bilateral agreements, the Commission and the United States 

jointly established the U.S.-EC Technical Working Group on the RED (TWG), to examine how 

long-standing U.S. conservation programs address RED sustainability criteria and create the 

framework for a bilateral agreement to accept U.S. exports of biofuel feedstock as compliant with 

the sustainability goals of the RED. During the final meetings of the TWG, the Commission stated 

that U.S. conservation laws and programs must be identical to those outlined in the RED 

sustainability criteria. At the TWG, the United States noted that requiring identical legislation 

raises questions under the WTO Agreement. The United States also contended that the results of 

U.S. conservation laws and programs address the RED sustainability criteria and provide verifiable 

compliance measures for mass balance accounting. The TWG agreed to suspend discussions on a 

specific RED bilateral agreement at the beginning of the T-TIP negotiations. In 2014, the United 

States will continue to raise concerns with the RED and press for a solution as T-TIP negotiations 

proceed. 

The EU’s RED continues to exert considerable uncertainty in global biofuel and biofuel feedstock 

markets, and to disrupt trade through a very narrow approach to assessing conformity with its 

sustainability criteria. The United States will continue to seek recognition from the EU of 

alternative approaches that can provide equivalent outcomes in ensuring sustainable production of 

biofuel feedstock. By recognizing the United States’ longstanding environmental record, the EU 

could quickly realize our shared goals of cheaper, lower GHG emitting fuels and a significant 

increase in trans-Atlantic trade.

Transport Fuel -- Fuel Quality Directive

The EU’s revised Fuel Quality Directive (FQD), adopted in 2009 as part of the EU’s Climate and 

Energy package, requires fossil fuel suppliers to reduce the lifecycle greenhouse gas intensity of 

transport fuel by six percent by 2020. The Directive granted the Commission the power to develop 

a methodology for calculating the GHG life-cycle emissions for transport fuels. The United States 

strongly supports the goal of the FQD of reducing GHG emissions. We have, however, raised 

concerns with the Commission regarding the lack of transparency and opportunity for public 

comment in the development of the Commission proposal for the methodology for calculating the 

GHG life-cycle emissions for transport fuels. 

Over the past eighteen months, DG Climate has prepared an impact assessment on different options 

for this methodology and held two stakeholder sessions on the impact assessment process itself. 

However, the draft impact assessment paper was not made public and there was no opportunity to 
75

comment on it. There is no detailed public information regarding implementation options under 

consideration by the Commission, or what the timeline for a final Commission proposal to the 

Council and Parliament will be. The lack of transparency in this process drew criticism from the 

United States, U.S. and European industry, and EU parliamentarians. The United States has raised 

these transparency issues bilaterally with the EU, including at the WTO TBT Committee. 

Trucks – Maximum Authorized Dimensions 

U.S. industry has long raised concerns that the EU’s truck length requirements were too prescriptive 

and unnecessarily restrict U.S. exports of aerodynamic and fuel efficient trucks to Europe. On April 

15, 2013, the EU issued a “Proposal for a Directive of the European Parliament and of the Council 

amending Directive 96/53/EC laying down for certain road vehicles circulating within the 

Community the maximum authorized dimensions in national and international traffic and the 

maximum authorized weights in international traffic.” The EU notified the proposal to the WTO in 

G/TBT/N/EU/109 on May 24, 2013. The proposal stated that “in light of evolving market and 

available technologies” it is necessary to amend existing regulations (Directive 96/53/EC) “to 

improve the aerodynamics of vehicles and their energy efficiency, while continuing to improve road

safety.”

EU vehicle safety regulations measure truck lengths from the front bumper of the tractor to the rear 

of the trailer. The regulatory approach taken by the U.S. Department of Transportation is based on 

the length of the trailer. This regulatory divergence has driven the development of two, contrasting 

schools of truck design: streamlined aero-nosed products in the United States and shorter, blocky

“cabovers” in the EU. In the EU, and among countries that have adopted EU’s approach, the 

allowable length of a truck tractor-semitrailer combination is 16.5 meters. Because American aeronosed truck tractors are approximately 1.5 meters longer than European cabover truck tractors, they 

must pull shorter semitrailers in order to meet the truck tractor-semitrailer combination limit of 

16.5, which diminishes payload capacity. Thus, while the EU approach does not ban American 

aero-nosed truck tractors, they are economically disadvantaged, because every measured 

inch/centimeter of the tractor up front means less space for paying cargo. Although aero-nosed 

trucks are longer, they have many advantages over cabover trucks. The best aero-nosed tractor is 

over 19 percent more aerodynamic and over nine percent more fuel efficient than the best cabover. 

As a result, aero-nosed products emit fewer greenhouse gases. 

The EU’s proposal contained several elements to promote greater energy efficiency, including 

revisions that would allow truck tractor-semitrailer combinations to exceed 16.5 meters in length

and to add flaps to the rear of the vehicle. The proposal also contained the statement: “The only 

purpose of these exceedances is to allow the addition to the rear of vehicles or vehicle combinations 

of devices increasing their aerodynamic characteristics.” It was therefore unclear whether the EU’s 

proposal would provide an opening to the longer American aero-nosed truck tractors regardless of 

whether devices were to be added at the rear. The Vice President of the European Commission has 

stated that the EU’s “intention is precisely to allow the potential use of slightly larger, more 

aerodynamic tractors - and/or rear devices, at the choice of manufacturers and end-users” and this 
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intention would be captured in the still-to-be-developed technical specifications on aerodynamic 

designs or rear devices for trucks.

Food – Labeling Requirements 

EU framework regulation 1169/2011 on the provision of food information to consumers – published

in the Official Journal on November 22, 2011 – combines several EU directives and establishes new 

horizontal food labeling requirements. Most provisions will apply from December 13, 2014, with 

mandatory nutrition labeling effective December 13, 2016. Although regulation 1169/2011 was 

adopted in December 2011, the EU still needs to propose and adopt a series of additional 

regulations to implement general provisions of the framework, and if necessary, conduct the 

corresponding impact assessments that normally accompany such proposals. 

The United States has trade concerns regarding how certain elements of regulation 1169/2011 will 

be implemented, and is monitoring developments closely. The chief concern of U.S. industry is that 

regulation 1169/2011 appears to provide wide latitude for EU Member states to adopt non-uniform 

implementing regulations. U.S. industry is concerned about the burden of meeting multiple labeling 

requirements, particularly if those requirements cannot be met through stickering or supplemental 

labeling. During the consultative process, the United States sought assurances that imported 

products will be subject to harmonized EU requirements, regardless of port of entry, and that 

compliance with national schemes (such as the United Kingdom and Ireland’s traffic light 

requirements) would remain voluntary.

The United States is working bilaterally to better understand the rationale and basis for mandatory 

labeling requirements that appear more stringent than those found in the Codex General Standard. 

The United States is also seeking assurances that only harmonized EU requirements will be 

mandatory and that national labeling requirements remain voluntary.

Agriculture Products – Quality Schemes

Traditionally, EU policies on agricultural quality have been developed on a piecemeal basis. On 

May 28, 2009, the European Commission published its “Communication on Agricultural Product 

Quality Policy” aimed at clarifying and simplifying its product quality policies. The 

Communication addresses EU quality schemes, marketing standards and other certification and 

labeling schemes, such as organics and animal welfare. It follows on from a Green Paper published 

in October 2008, and outlines a policy framework for three complimentary quality schemes: the 

geographical indication scheme, which consists of Protected Designation of Origin (PDO) and 

Protected Geographical Indication (PGI); the “Traditional Specialty Guaranteed” (TSG) scheme; 

and optional quality terms. Optional quality terms are defined as additional information about 

product qualities such as “first cold-pressed extra virgin olive oil” and “virgin olive oil.” A separate 

measure addresses the marketing standards for wine and spirits, notified to the WTO on September 

11, 2011.
77

The three quality schemes are either certification schemes for which detailed specifications have 

been laid down and which are checked periodically by a competent body; or labeling schemes 

which are subject to official controls and communicate the quality of a product to the consumer. 

Schemes can indicate that a product meets baseline requirements but can also be used to show 

“value-adding qualities” such as specific product characteristics or farming attributes (e.g. 

production method, place of farming, mountain product, environmental protection, animal welfare, 

organoleptic qualities, Fair Trade, etc.). Schemes can be voluntary or mandatory. 

The United States submitted comments on the “Proposal for a Regulation of the European 

Parliament and of the Council on agricultural product quality schemes (COM (2010)733)” (notified 

as G/TBT/N/EEC/379) to the EU on August 2, 2011 and received a response from the EU in 

December of 2011. The United States asked the EU to clarify the level of specificity required to 

identify a “place of farming,” as well as the legitimate objective for such a requirement. The U.S. 

comments also highlighted concerns that the proposal establishes a framework that provides a 

“legal basis” for expanding place of farming requirements to all processed products from specified 

commodities. The EU responded that “place of farming” will be applied on a case-by-case basis, 

following impact assessments, and further noted that the definition of “place of farming” will 

change from one product to another. 

The European Parliament and Council finalized its regulation on quality schemes for agricultural 

products and foodstuffs EU 1151/2012 in November 2012. In order to implement its general 

provisions, 1151/2012 gives the Commission the power to adopt delegated or implementing acts, 

and the Commission has not yet issued such measures. The specific provisions in the expected 

delegated and implementing acts may create additional challenges for U.S. exporters. 

The United States remains concerned that “place of farming” requirements are unclear and difficult 

to comply with, and lack a basis in international standards. Codex, for instance, maintains no 

recommendation for place of farming designations, and has rejected proposals that would have 

expanded country of origin designations to foods with multiple ingredients, because such labeling 

caused consumer confusion. 

Further, the United States remains concerned over certain aspects of the TSG requirements, 

including whether “prior use of a name” includes a trademark or prior geographical indication. The 

United States is also seeking clarification of the manner of precedence in determining TSG 

requirements relative to trademarks. Despite assurances from the EU that the provisions of 

1151/2012 “ensure that a prior trademark is not affected by the registration of a TSG,” it remains 

unclear whether prior use of a trademark will be grounds for opposing registration of a TSG. 

Further, the EU has shortened the comment period to oppose a registration from six months to two

months. The United States views two months as insufficient time to prepare a dossier to oppose a 

proposed PDO/PGI/TSG.

Wine – Traditional Terms
78

Separate from its policies on agricultural quality schemes, the EU continues to aggressively seek 

exclusive use of “traditional terms” such as “tawny, ruby, and chateau” on wine labels. Such 

exclusive use of traditional terms impedes U.S. wine exports to the EU. Wines with a trademark 

granted before 2005 can use the terms, but more recent products cannot. In December 2013, it will 

be more than three years since the U.S. industry submitted applications to be able to use the terms, 

with no final confirmation that the applications have been approved from the EU. The EU recently 

approved the U.S industry’s applications for use of terms “cream” and “classic,” but the EU’s 

delayed application approval process for other terms raises questions about the consistency of this 

process with the TBT Agreement. The United States has raised this issue repeatedly in the WTO 

TBT Committee for several years, and beyond approving two terms, the EU has not taken any 

visible steps to address our concerns. 

At the March 2013 EU-U.S. Wine Bilateral meeting, representatives from DG Agriculture and 

Rural Development (DG Agri) indicated that the EU would reform the application process. They 

acknowledged difficulties with the term-by-term approval process and that the Commission will 

undertake to apply a different approval procedure. The Commission did not provide any timeline 

for completing the application process reforms. In June 2013, the World Wine Trade Group

(WWTG) expressed to DG Agri that WWTG countries, including the Argentina, Australia, Canada, 

Chile, Georgia, New Zealand, South Africa, and United States, are frustrated with the EU’s 

application process, which seem to be more trade restrictive than necessary. The EU stated that it 

would take WWTG’s considerations into account.

The United States continues to stress to the Commission that common usage names of products 

should not be absorbed into quality schemes, whether for wine or other products. If a Codex 

standard exists or if the name is used in a tariff schedule or by the World Customs Organization, the 

United States believes that the name should be excluded from the quality schemes. The United 

States has further pressed that new certification and labeling schemes not be required for market 

access; however, where the EU implements such schemes, efforts should be made to acknowledge 

voluntary U.S. industry definitions. Similarly, U.S. processes and procedures should be acceptable 

for labeling requirements and system and process comparability with industry definitions should be 

sought in order to minimize any negative market access impact for U.S. exports.

Distilled Spirits – Aging Requirements

The EU requires that for a product to be labeled “whiskey” it must be aged a minimum of three 

years. U.S. whiskey products that are aged for a shorter period cannot be marketed as “whiskey” in 

the EU market or other markets, such as Israel and Russia that adopt EU standards. The United 

States views a mandatory three-year aging requirement for whiskey as unwarranted. In fact, recent 

advances in barrel technology enable U.S. micro-distillers to reduce the aging time for whiskey. In 

2014, the United States will continue to urge the EU and other trading partners to end whiskey 

aging requirements that serve as barriers to U.S. exports.

India
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The United States discusses TBT matters with India during WTO TBT Committee meetings and on 

the margins of these meetings. The U.S. government also discusses such matters in bilateral 

meetings, including under the U.S.-India Trade Policy Forum and the U.S.-India Commercial 

Dialogue.

In addition, the U.S. Trade and Development Agency (USTDA) funds a program with the 

Confederation of Indian Industry (CII) to facilitate India’s development of a transparent and more 

streamlined system of standards, conformity assessment, and technical regulations. ANSI’s 

standards portal contains information regarding the U.S. and Indian standardization systems. 

(www.standardsportal.org). 

Legal Metrology - Packaged Commodities Rules

The Legal Metrology (National Standards) Rules, 2011 issued by India’s Department of Consumer 

Affairs have been in force since 2011. India first notified them to the WTO upon their third 

amendment on in 2012, which entered into force after just 40 days notification. The rules were 

further amended in June of 2013 and published in India’s Gazette, however, India did not notify the 

amendment to the WTO, and the changes have now entered into force. These rules stipulate that 

all pre-packaged commodities are prohibited, unless they are in a standard quantity and carry all 

prescribed declarations. Varying interpretation and enforcement of the requirements, and 

conflicting provisions with labeling and packaging requirements maintained by Food Safety and 

Standards Authority (FSSAI) and the Ministry of Commerce (MOCI), have created an uncertain 

environment, causing detention of shipments at the port of entry and cancellation of import 

contracts. U.S. officials in New Delhi highlighted concerns to India’s Secretary of Consumer 

Affairs in October 2013, and met with more than 21 other Ministries reporting similar detentions 

and trade challenges related to the Legal Metrology and FSSAI requirements. 

Mandatory Container Sizes

The Legal Metrology Rules create mandatory package sizes in metric units excluding many U.S. 

food products from the market since they are packaged in traditional English units (fluid ounces, 

pounds, and pints). Highly impacted commodities include canned and bottled drinks, packaged 

biscuits and bottled vegetable oils. Mandatory package size requirements are not recommended by 

international standards. Net weight declaration, supported by Codex and other international bodies, 

better protects consumers from fraudulent packaging practices. 

Wholesale Foods Labeling

The Legal Metrology standard also creates a definition for wholesale foods that is inconsistent with 

similar requirements laid out by FSSAI in the Food Safety and Standards Regulations (FSSR). 

Further, the measure requires that all products be labeled with dates of production, importation, and 

expiration and that at least 60 percent of a product’s shelf life must remain at the time of 

importation. This has led Indian Customs officials to reject or detain shipments of unprocessed
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agricultural products, such as tree nuts and apples, which do not have a specific production date. 

FSSR

The United States has detailed concerns about onerous India-specific labeling issues in previous 

TBT Reports since the FSSR were published in India’s Gazette in 2011. India’s responses have 

failed to provide additional or reliable information with regard to how the elements of this measure 

advances safety or efficacy or quality of the products in question or meets the specific needs of

India. The United States continues to seek clarification about India’s specific needs in those 

instances where the FSSR appears inconsistent with the Codex General Standard for the Labelling 

of Prepackaged Foods recommended practices or international practice.

In 2013, India established health advisory statements for glucose, plant stanol esters, and dietary 

fibers in the FSSR. The United States asked India in October 2013 to confirm if these advisory 

statements were needed for imported products and is awaiting a response. India also established in 

the FSSR requirements for the mandatory display of the FSSAI “license number” along with the 

FSSAI logo in the principal display panel of food package consignments. India did not notify the 

new requirements to the WTO. FSSAI confirmed in December 2013 that imports may comply with 

the license and logo labeling through the use of a sticker, however, the United States remains 

concerned that India continues to develop costly national level requirements.

The United States will continue to press India to resolve these issues in 2014.

Telecommunications Equipment – Security Regulations

In 2009 and 2010, India promulgated a number of regulations negatively impacting trade in 

telecommunications equipment, including policies on mandatory transfer of technology and source 

codes as well as burdensome testing and certification requirements for telecommunications 

equipment. While international stakeholders successfully lobbied India to roll back most of these 

measures, India retained the objective of testing all “security-sensitive” telecommunications 

equipment in India by April 2013. U.S. Government officials and U.S. industry have continued to 

press India to reconsider the domestic testing policy and to adopt the international best practice of 

using international common criteria and accepting products tested in any accredited laboratory in 

India or elsewhere. In October 2013, India announced that the domestic security testing deadline 

would be extended to July 1, 2014. However, there is no indication that India’s domestic security 

testing capacity, which is currently very limited, will increase sufficiently by that time.

In February 2012, India announced a Preferential Market Access (PMA) policy for domestically 

manufactured telecommunications equipment. The policy stated that domestically manufactured 

equipment would receive preference in government procurement and in some types of private sector 

procurement owing to a combination of India’s twin goals to expand its domestic manufacturing 

capacity and to protect the security of its telecommunications networks. Following significant 

engagement with the government of India by senior U.S. Government officials and U.S. industry,
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India revised the PMA in December 2013. The revised policy continues to require that 

domestically manufactured goods constitute a certain percentage of the electronic products procured 

by government entities. The revised PMA policy also applies the same requirement to 

“procurement of electronic products made under all Centrally Sponsored Schemes and grants made 

by the Central Government.”

The United States will continue to seek clarification on the scope and application of the revised 

PMA policy from the government of India and closely monitor its implementation in 2014.

Electronics and Information Technology Equipment – Safety Testing Requirements

U.S. electronics and IT goods manufacturers have raised concerns about the Indian Department of 

Electronics and Information Technology’s (DEITY) September 2012 order that mandates 

compulsory registration for fifteen categories of imported electronic and IT goods. The policy, 

originally set to take effect April 2013, mandates exporters to register their products with 

laboratories affiliated or certified by the Bureau of Indian Standards (BIS). This is despite the fact 

that all U.S. electronic exports currently sold in India are fully certified in internationally 

recognized laboratories, and the government of India has never articulated how such a domestic 

certification requirement advances India’s legitimate public safety objectives. Notwithstanding 

ongoing efforts by global industry to engage the government of India to resolve concerns and 

ambiguities in the policy without undermining those objectives, the Order entered into force in 

January 2014.

India currently has seven government and private laboratories accredited by BIS for testing and 

certification – far fewer than will be necessary to accommodate the high volume of electronic goods 

the country imports. Accordingly, enforcing these requirements could result in hundreds of 

millions of dollars’ worth of U.S. exports being locked out of the Indian market, causing great 

concern for U.S. companies. To date, BIS has maintained that it will not recognize certification 

from laboratories located outside of India. 

Although U.S. industry would ultimately like to see the entire policy repealed, an important first 

step is to seek an exemption for Highly Specialized Equipment (HSE), including servers, storage, 

printing machines, and IT products that are installed, operated, and maintained by professionals 

who are trained to manage the product's inherent safety risks. These products pose little risk to the 

general consumer public. U.S. companies have already incurred significant expenses due to testing 

samples being destroyed during the safety testing process in Indian labs. Indian test labs have also 

indicated that they do not have the capacity to test some products, that require industrial power 

supply, exceed household or office voltage, or are very large in size and weight. Moreover, 

exporters are forced to leave their products in these labs for extended and undefined periods of time.

USTR has been actively raising this issue bilaterally, in the WTO TBT Committee in 2013, and will 

continue to discuss with the Government of India in 2014.
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Proposed Amendment to the Hazardous Waste Act

In 2008, India’s Ministry of Environment and Forests (MoEF) adopted rules styled as the 

“Hazardous Wastes (Management, Handling and Transboundary Movement) Rules, 2008,” which 

set forth requirements and procedures for the storage, handling, and disposal of hazardous waste. 

Following a number of amendments in the intervening years, in 2011 MoEF proposed further 

amendment to the Hazardous Wastes Rules, referred to by MoEF as the “Fifth Amendment.” The 

proposed Fifth Amendment, published in November 2013, but not notified to the WTO, sets out 

conditions for the import and movement of used and refurbished electrical and electronic equipment 

(EEE). The United States fully supports the protection of the environment and health against 

adverse impacts of wastes. U.S. industry has expressed concerns that, under the proposed Fifth 

Amendment, hazardous waste controls on imports of used EEE for direct reuse and imports of 

refurbished EEE pursuant to a service warranty, and other similar controls on EEE, would impose 

unnecessary burdens on trade that facilitates reuse and extension of life of EEE to the benefit of the 

environment. 

The United States will continue to press India to resolve these issues in 2014.

Indonesia

Bilateral Engagement

The United States discusses TBT matters with Indonesia both bilaterally and during WTO TBT 

Committee meetings and on the margins of such meetings. Additionally, the United States –

Indonesia TIFA Council provides a forum for bilateral discussions on a variety of trade-related 

issues, including standards-related issues. The United States and Indonesia also participate actively 

on standards and conformity assessment issues through ASEAN and APEC. In June 2013, 

Indonesia and the United States co-hosted a workshop under USAID’s Standards Alliance program 

aimed at promoting transparent, predictable, and effective regulatory practices that will encourage 

enhanced trade and investment.

Horticulture Products – Labeling Requirements

In September 2012, Indonesia issued Ministry of Agriculture’s (MOA) Regulation 60 and Ministry 

of Trade’s (MOT) Regulation 60 (amending MOT Regulation 30), which have since been replaced 

by MOA Regulation 86/2013 and MOT Regulation 16/2013, as amended by MOT Regulation 

47/2013 in August 2013. These regulations impose a broad range of requirements on the 

importation of horticultural products into Indonesia and include provisions related to labeling and 

packaging that, among other elements, require that labels in the Bahasa language be attached to the 

packaging prior to entering the Indonesian customs area. Indonesia did not notify these regulations 

to the WTO TBT Committee. The United States had raised the issue of allowing supplemental 

labels to comply with Bahasa labeling requirements at the WTO TBT Committee during 2011 in 

regard to the September 1, 2010, Circular Letter HK.05.01.1.52.09.10.8502 from Indonesia 
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National Agency for Drug and Food Control. The United States will continue to raise concerns in 

2014 regarding the labeling aspects of the measures.

Toys – Standards and Testing Requirements

In October 2013, Indonesia began enforcing a new mandatory toy standard – Ministry of Industry

Regulation 24 of 2013 (SNI:8124:2010), despite expressions of concern and requests for delay 

made bilaterally and in the WTO TBT committee in 2013 by the United States and other trading 

partners. A particularly problematic aspect of the new regulation was a requirement that a 

manufacturer establish conformity through in-country testing in Indonesia. When hundreds of 

shipments of toys became stuck at Indonesian ports, Indonesia delayed enforcement of the 

regulation until April 2014. As part of the delay, Indonesia also announced that it would accept test 

reports from foreign ILAC-accredited laboratories for two years, after which the regulation will 

require a bilateral agreement to avoid in-country testing. Despite the delay, the U.S. toy industry 

remains concerned about technical requirements, such as the sampling and frequency of testing, as 

well as the future requirement for bilateral agreement to avoid in-country testing. The United States 

will remain engaged with Indonesia on this issue in 2014.

Cell Phones, Handhelds, Tablets and Laptops – Product Testing

Indonesia has issued a number of measures that make it more difficult to import cellular and WiFiequipped products. In late 2012, Indonesia issued MOT Regulation 82, which was subsequently 

amended by MOT Regulation 38 in 2013, and Ministry of Industry (MOI) Regulation 108. Under 

these measures, to obtain an import license, companies must provide product identification numbers 

for each imported item, and receive: (1) an import certification from MOI; (2) a certification for 

telecommunication device and equipment from the Ministry of Communication and Information 

Technology (KOMINFO); and (3) a label in Bahasa.

In May 2013, KOMINFO published Postel Regulation 5, which imposes strict testing requirements 

on the devices, covered by MOT 82/2012, as well as notebooks and personal computers. This 

measure requires imported cell phones, tablets, handhelds, laptops, and other equipment with 

Bluetooth or wireless LAN features to be tested at the device-level rather than the more common 

modular-level. Further, tests must be conducted in Indonesian test labs. The Communications 

Ministry also requires companies to provide product identification numbers for each individual 

product to be imported. U.S. companies reported that they were unable to provide such numbers 

months in advance, as required by the measure. In response, the United States and other trading 

partners raised concerns with Indonesia regarding these new requirements, both bilaterally and in all 

three WTO TBT Committee meetings in 2013. The United States and U.S. companies also raised 

concerns with Indonesia on this issue. As a result, the Ministry delayed full implementation until 

January 2014.

The United States will remain engaged on these issues directly with Indonesia and by supporting 

more regularized consultations between U.S. industry and the Indonesian government.
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Korea

Bilateral Engagement

Korea and the United States regularly discuss TBT issues during and on the margins of the WTO 

TBT Committee meetings, working groups set up under the United States – Korea Free Trade 

Agreement (KORUS) such as the Automotive Working Group, and through other bilateral 

consultations.

Chemicals – Act on the Registration and Evaluation of Chemicals 

On May 22, 2013, the Act on the Registration and Evaluation of Chemicals became law. Under the 

law, manufacturers and importers of chemical substances subject to the law will be required to be 

registered and subject to annual reporting requirements. On February 18, 2014 Korea’s Ministry of 

Environment released draft implementing regulations, which it plans to finalize by summer 2014, 

with expected entry into force on January 1 2015. The draft regulations allow simplified 

registration for new chemicals under 1 ton. Industry still has concerns about the high costs and 

potential release of sensitive business information involved with the Only Representative reporting 

system, and the regulation of chemicals registered in a “gap” period between 2012 and 2014. In 

2014, the United States will continue to monitor developments and engage with Korean authorities 

to share concerns and to minimize or eliminate unwarranted burdens contained in the implementing 

regulations.

Organic Products – Requirements and Conformity Assessment Issues

Korea’s Act on Promotion of Environment-Friendly Agriculture and Fisheries and Management and 

Support for Organic Products (the “Organic Act”), became effective on January 1, 2014. Under the 

Organic Act, U.S. processed organic exports to Korea are to be certified by a certifier accredited by 

Korea’s Ministry of Agriculture, Food, and Rural Affairs as meeting particular standards in order to 

continue to be labeled as organic, and processed organic products will need to be recertified. Many 

U.S. producers and certifiers are reluctant to seek product re-certification under the Organic Act due 

to prohibitive costs and technical difficulties related to ingredient certifications and certifier 

readiness. However, the Organic Act permits the conclusion of equivalence agreements, which 

could potentially alleviate burdens on U.S. products and allow U.S. certified products to be labeled 

as organic in Korea without have to undergo re-certification by Korean authorities. Nevertheless, 

the Organic Act did not permit Korea to start the official negotiations on equivalence agreements 

before January 1, 2014 –creating a gap between the time U.S. organic exports will be subject to 

these requirements but before an agreement for equivalence can be concluded. Korea has sought 

measures to avoid a disruption in trade in the absence of equivalence agreements, including partial 

exemptions for certain ingredients, and announced on December 31, 2013 that there will not be 

assessments of penalties during a six-month “education period,” which will end on July 1, 2014. 

Unfortunately, trade has already been considerably disrupted because Korean importers are 

reluctant to make purchases amidst present uncertainties. The United States has repeatedly urged 
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Korea to extend the current organic labeling standards or provide a provisional recognition of the 

U.S. National Organic Program (NOP) until an equivalence agreement can be concluded. In 2014, 

the United States will continue to engage Korea on this issue, including working to expedite the 

conclusion of the equivalence agreement between the U.S. and Korea.

UNI-PASS customs documentation – Formula Disclosure Issue

In September 2012, U.S. stakeholders alerted the United States that online Korean Customs systems 

required disclosure of 100 percent of all formulas and ingredients in products in order to receive 

customs clearance. Such disclosure risks the security of proprietary information. After engagement 

with U.S. authorities, Korea confirmed in December 2013 that it had removed these requirements in 

its online customs UNI-Pass system and now only requires the listing of the top one to two 

predominant ingredients. This new system has yet to be thoroughly tested in practice by U.S. 

stakeholders. The United States will continue to monitor this issue in 2014.

Information Technology Equipment – Electrical Safety Regulations

U.S. industry has been working closely with the Korean Agency for Technology and Standards 

(KATS) and the Radio Research Agency on the reorganization of safety regulations for information 

technology equipment. The United States has advocated for streamlined procedures that reflect the 

realities of contemporary manufacturing and would provide an appropriate level of safety 

certification for low risk information technology equipment, such as printers and computers. KATS 

released its final Safety Regulations rule for information technology equipment, which entered into 

force on July 1, 2013. These new regulations addressed many long standing U.S. concerns, 

including by expanding the scope of products subject to a supplier’s declaration of conformity, and 

adopting the most current IEC standard. However, some concerns continue to be outstanding. For 

example, the regulation requires separate safety certification with respect to each factory’s products,

even for identical products produced by the same company but in a different factory. The final rule 

also expanded the scope of products requiring registration beyond what had been envisioned in the 

draft regulation, and gave companies an extremely short timeframe for implementation. Moreover, 

there is presently no certificate renewal process. Furthermore, despite being a Member of the IEC

System for Conformity Testing and Certification of Electrical and Electronic Components, 

Equipment and Products Certification Bodies’ Scheme (CB), KATS is not currently accepting CB 

reports without additional testing. Additionally, the final rule imposes burdensome labeling 

requirements for information that could be disclosed instead in an insert or manual. Such an 

adjustment is particularly appropriate for products that have small physical sizes such as cell 

phones. In 2014, the United States will monitor implementation as the regulation is enforced and 

urge Korea to allow adequate implementation time for new products as its scope increases. 

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 in 
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practice means for 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 and Copper Indium Gallium 

Selenide. As a result, other leading types of thin film solar panels made by U.S. firms, including 

Cadmium Telluride (CdTe), cannot be tested or certified under the Korean standard and thus remain 

shut out of most of Korea’s market. The United States urged Korea at the 2012 bilateral trade 

consultations and at WTO TBT Committee meetings to adopt the relevant international standard, 

IEC 61646, without limiting its application solely to the type of thin-film solar panel its industry 

produces. If Korea did so, it would both facilitate trade and afford Korean consumers access to the 

best available technologies. In response to U.S. concerns, Korea conducted an environmental 

impact review on the use of cadmium in solar panels, and determined that a hazard existed for using 

CdTe. U.S. industry has raised methodological concerns with the studies Korea used to disqualify 

CdTe. The United States raised this issue with Korea in the March and October WTO TBT 

Committee meetings and will continue to discuss this issue with Korea in 2014.

Motor Vehicle Parts – Self-certification of Certain Spare Parts

In February 2013, Korea addressed concerns raised by U.S. industry and the U.S. Government 

regarding its establishment (through amendments to the Motor Vehicle Management Act and its 

related implementing regulations) of a requirement that five spare parts be self-certified to the 

relevant Korean Motor Vehicle Safety Standard (KMVSS). Concerns had been raised that the 

requirement would in some cases interfere with the ability to service motor vehicles certified to the 

U.S. Federal Motor Vehicle Safety Standards (FMVSS) in accordance with relevant provisions of 

KORUS. Following the submission of comments by industry and consultations with the United 

States, Korea clarified provisions in related administrative guidance and implemented the 

requirement such that this concern was resolved. As the scope of the self-certification requirement 

is set to expand to include additional spare parts in coming years, the United States will continue to 

monitor this issue and work with Korea to resolve any concerns that may arise.

Motor Vehicle Components – Compliance Testing of Sunroofs

In September 2013, in response to consumer complaints about failing sunroofs, Korean safety 

regulators at the Ministry of Land, Infrastructure and Transport and the Korea Automobile Testing 

and Research Institute conducted a product safety test of the sunroofs of all motor vehicle 

manufacturers whose models include sunroofs. However, both domestic and import vehicle 

manufacturers raised concerns that the test methodology used deviated significantly from the 

methodology prescribed in the relevant Global Technical Regulation developed by UNECE 

Working Party 29 under the 1998 Agreement and related FMVSS, and KMVSS in a manner that 

prejudices the test in favor of finding failure. The U.S. Government (as well as other governments) 

raised this issue with Korea on several occasions in the fall of 2013, including at senior levels. 

Korean regulators have not taken action based on the tests already conducted, and are studying the 

issue further, including through consultations with other countries’ regulators. The United States
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will continue to closely monitor this issue in 2014. 

Malaysia

Bilateral Engagement

The United States discusses TBT matters with Malaysia during and on the margins of the WTO 

TBT Committee meetings, and during TPP negotiations. The United States and Malaysia also 

participate actively on standards and conformity assessment issues through APEC.

Meat and Poultry Products – Halal Standards

As discussed in previous TBT reports, Malaysia requires all domestic and imported meat (except 

pork) to be certified as halal (produced in accordance with Islamic practices) by Malaysian 

authorities. Malaysian regulations require producers’ halal practices to be inspected and approved 

for compliance with Malaysian standards on a plant by plant basis prior to export.

In January 2011, Malaysia implemented a food product standard, MS1500: 2009, which sets out 

general guidelines on halal food production, preparation, handling, and storage. MS1500: 2009 

creates standards that go well beyond the internationally recognized halal standards, which are 

contained in the Codex Alimentarius. Specifically, the guidelines require slaughter plants to 

maintain dedicated halal production facilities and ensure segregated storage and transportation

facilities for halal and non-halal products. In contrast, the Codex allows for halal food to be 

prepared, processed, transported, or stored using facilities that have been previously used for nonhalal foods, provided that Islamic cleaning procedures have been observed.

In April 2011, Malaysia notified to the WTO its “Draft Malaysian Protocol for the Halal Meat and 

Poultry Productions.” The protocol provides additional information and guidance on complying 

with MS 1500: 2009. In May 2011, the United States provided comments on the protocol and 

subsequently raised concerns regarding the protocol during the June and November 2011 WTO 

TBT Committee meetings. Following that, Malaysia scheduled mandatory audits for 

establishments seeking to export to Malaysia. These audits took place in September 2012. The 

United States received notice from Malaysian officials in April 2013 that only one U.S. 

establishment passed the audit, with conditional approval pending certain corrections. FSIS replied 

in June 2013 that corrective actions had been taken by the halal certifier and company. The 

company underwent a halal only review and audit in September 2013 by the Department of Islamic 

Development Malaysia (JAKIM) and was informed in early 2014 that it failed the audit and would 

have to undergo another full audit to be certified. As a result of failing the audits, these 

establishments are accordingly prohibited from exporting to Malaysia.

The United States raised Malaysia’s halal requirements on the margins of the TPP negotiations 

throughout 2013, and will continue to press the issue in 2014. 
88

Mexico

Bilateral Engagement

The United States continues to discuss TBT matters with Mexico during WTO TBT Committee

meetings. The United States and Mexico also engage on standards and regulatory issues in the 

NAFTA Committee on Standards Related Measures, which met in February and October of 2012, 

and as part of the United States–Mexico High-Level Regulatory Cooperation Council, which met in 

August 2013. 

Standards System Overhaul

Mexico is moving to consolidate all Mexican standards development organizations (SDOs) into a 

single Mexican SDO, AMEXNOR. U.S. stakeholders are concerned Mexico has set the ambitious 

goal of AMEXNOR developing between 5,000 and 15,000 standards in the next several years. It is 

unclear how standards development is to be funded, but Mexico has indicated it is considering 

expanding and codifying the current fee structure, under which all certification bodies pay ten 

percent of their profits into a trust. Most U.S. SDOs are already engaged with the Mexican Bureau 

of Standards (Dirección General de Normas, part of the Secretariat of Economy) but nonetheless;

contend the process is not fully transparent. The United States and industry stakeholders will 

monitor standards development in Mexico to ensure that the process is fair and transparent, and 

allows for an opportunity to comment.

Energy Efficiency Labeling and Standby Power Usage Regulations

On September 10, 2010, Mexico published a “Catalogue of equipment and appliances used by 

manufacturers, importers, distributors and marketers that require mandatory inclusion of energy 

consumption information,” a regulation on energy efficiency labeling that is applicable to a 

significant number of electrical and electronic products and equipment. U.S. industry stakeholders 

expressed their concern that implementation of the regulation would impose additional burdensome 

and costly labels to their exports to Mexico. The regulation became mandatory on September 11, 

2011. U.S. and industry stakeholders remain concerned that this regulation sets a poor precedent

and places unnecessary regulations on an extensive list of electronic products that operate at a 

relatively low wattage and are not regulated in the United States. 

On November 14, 2012, Mexico published proposed changes to NOM-032, a regulation that would 

provide standby energy consumption limits, testing methods, and labeling requirements for certain 

electrical and electronic equipment, including digital television adapters, decoders for television 

reception, audio reproduction units, image reproduction equipment, and televisions with LED, 

LCD, or plasma displays. NOM-032 covers most of the same products as the previous 

aforementioned catalogue, and nearly duplicates, though does not replace it. 

U.S. industry stakeholders requested a delay in the implementation of NOM-032 so that the 
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proposed changes could be analyzed, modified, and clarified. Mexico only granted a slight delay of 

the implementation period of 240 days; it finalized and published the regulation in the Official 

Gazette on January 23, 2014. 

U.S. industry is concerned that the two regulations together lead to duplicative labeling and 

conformity assessment regimes, resulting in unnecessary barriers to trade. U.S. industry argues that 

there is no real energy efficiency purpose behind the regulations and that they impose burdensome 

costs and procedural requirements without offering any added energy efficiency information for the 

consumer. Additionally, U.S. industry contends that there are likely no energy savings associated 

with the regulations and that NOM-032 does not consider or attempt to achieve harmony with wellestablished U.S. and Canadian energy efficiency or disclosure programs, such as Energy Star.

U.S. industry met with Mexico’s National Commission for Efficient Energy Use (CONUEE) 

several times in 2013 to discuss the regulations when they were still in draft form. Although 

CONUEE was responsive on engaging in discussions of NOM-032 requirements, it did not alter or 

revise the regulation to address U.S. industry’s concerns. The United States will continue to 

monitor this issue in 2014.

Sanitation Pipes

As noted in prior TBT Reports, the United States was concerned that Mexico’s National Water 

Commission (NWC) had not recertified certain U.S.-origin plastic pipes for waste water systems, 

drinking water systems, and domestic service connections, under the Mexican recertification 

standard applicable at the time (NOM-001-CONAGUA-1995). According to U.S. industry, NWC 

had instead sought to enforce an obsolete ISO standard on high density polyethylene (HDPE) 

plastic pipes, that was not incorporated into the Mexican recertification standard and that relied on 

design and descriptive characteristics, rather than performance abilities. Furthermore, although 

both HDPE pipe and polyvinyl chloride (PVC) pipe – a competing product – could not satisfy the 

design characteristics of the ISO standard, NWC appeared to only be enforcing this standard on 

HDPE pipe and not PVC pipe, the latter of which is manufactured predominantly by the domestic 

industry. U.S. industry reported that HDPE pipe met the recertification standard contained in 

NOM-001-CONAGUA-199, as well as relevant performance characteristics as described in other, 

more up to date, state of the art international standards.

The new certification standard adopted by Mexico appeared to benefit Mexican made pipes at the 

expense of U.S. made HDPE pipes. The exclusion of U.S. made HDPE pipes was significant, as 

the collective market for plastic pipe in Mexico at its peak was well in excess of US $100 million.

The United States raised this issue with Mexico both bilaterally and in the WTO TBT Committee

meetings, and requested that Mexico ensure that the standards NWC adopted applied on a nondiscriminatory basis, were science-based, and were developed through transparent processes as 

required by the TBT Agreement. Additionally, the United States encouraged Mexico to apply the 

Mexican standard as written. On February 17, 2012, NWC released an amended mandatory 
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standard, NOM-001-CONAGUA-2011, which authorized acceptance and use of standards that are 

utilized in the markets of Mexico’s trading partners, including the United States.

Despite accepting U.S. HDPE manufacturers’ requests for recertification and the completion of 

relevant testing, NWC stated in February 2013 that it still could not recertify HDPE plastic pipe. 

NWC suggested that it was unable to confirm that ASTM International is an internationally 

recognized standard setting body, notwithstanding the facts that the amended mandatory 

recertification standard did not appear to limit the standards for recertification to only those 

produced by internationally recognized standards setting bodies and that ASTM International is 

generally recognized as such a body.

In 2013, the United States continued to raise this issue with Mexico both bilaterally and in the WTO 

TBT Committee. As a result, in November 2013, NWC finally issued U.S made HDPE plastic pipe 

a three year certification. The United States will continue to monitor developments to ensure that 

U.S. manufacturers of sanitation pipes can compete on a non-discriminatory basis.

Peru

Bilateral Engagement

The United States discusses TBT matters with Peru during and on the margins of WTO TBT 

Committee meetings, and in the WTO TBT Committee of the United States – Peru Trade Promotion 

Agreement (TPA). The first meeting of the TBT Chapter Committee was held in September 2013.

Nutritional Labeling and Restrictions on Advertising of Food to Adolescents

On May 16, 2013, Peru enacted the Act to Promote Healthy Eating Among Children and 

Adolescents. This law will require a mandatory warning statement for prepackaged foods 

considered to have high contents of sugars, sodium, saturated fat, and trans fats. This warning 

statement must be displayed on the front display panel of the foods and warn potential consumers to 

“avoid excessive consumption” or, in the case of trans fats, to “avoid consumption” entirely. The 

Act also lays out restrictions with respect to the advertising and promotion of certain affected foods 

to children and adolescents.

Although the United States understands the public health objective that this law is aiming to 

address, it has raised concerns to ensure that Peru provides a reasonable timeline for the enactment 

of implementing regulations and to ensure that such regulations do not cause unnecessary trade 

disruptions and are applied fairly. For example, it appears at present that are “foods and nonalcoholic beverages in their natural states, not subject to processes of industrialization” are excluded 

from the scope of the Act. This could result in preferential treatment for Peru’s domestic food 

industry, such as street vendors, whose food products may contain the same levels in sodium, 

sugars, and saturated and trans fat as the prepackaged foods targeted under the Act. 
91

The United States submitted written concerns about the regulatory implementation timeline to 

Peru’s Inquiry Point on May 9, 2013, and followed up with a diplomatic note outlining concerns on 

May 13, 2013. Additionally, on September 24, the Peru Prime Minister’s Chief of Staff and his 

Healthy Eating Committee met with U.S. representatives from the Food and Drug Administration’s 

Center for Food Safety and Applied Nutrition and the U.S. Department of Agriculture’s Foreign 

Agricultural Service and Food and Nutrition Service. This issue has also been discussed in the 

framework of the United States – Peru FTA, with senior level officials in Lima, at the WTO TBT 

Committee in June and October 2013, with supporting interventions by Argentina, the EU, 

Guatemala, Mexico, and Switzerland, and on the margins of other meetings. In the WTO TBT 

Committee, some Members highlighted concerns that less trade restrictive approaches exist, that the 

present maximum daily nutrient thresholds lack a scientific basis, and that mandatory symbols and 

warning statements that are inconsistent with international standards might create unnecessary fear 

in consumers. 

In 2014, the United States will continue to monitor the development of the implementing 

regulations, continue its discussions with the government of Peru, and explore opportunities for 

technical exchanges.

Moratorium on Planting Genetically Engineered Crops

On November 14, 2012, Peru published implementing regulations, for a minimum of ten years, on 

planting biotechnology crops. The implementing regulations, which would impose stiff penalties 

for noncompliance, appear to lack requisite details and guidance necessary to understand their 

application. Accordingly, on June 21, 2013, the United States submitted comments on the 

implementing regulations, noting that the level of the fines established by the proposed fine 

schedule appeared unreasonable and is a significant deterrent to shipping seed products to Peru. In 

addition, the U.S. comments noted that the fine schedule did not provide adequate clarity as to how 

the violations listed will be identified.

The United States urged Peru to notify the implementing regulations to the WTO at the June and 

October 2013 WTO TBT Committee meetings, as well as during bilateral discussions in the context 

of the United States-Peru TPA meeting held in 2013. The United States also asked Peru questions 

related to this issue during the November 2013 WTO Trade Policy Review of Peru.

The United States, other trading partners, and Peruvian domestic interests, have actively engaged 

with Peru on this matter. Peru is presently in the process of considering amendments to the 

implementing regulations. The United States will continue to carefully monitor this issue in 2014. 

Labeling of Biotech Foods

On June 27, 2011, Peru notified to the WTO its Draft Supreme Decree Approving the Regulations 

Governing the Labeling of Genetically Modified Foods. The proposal would mandate that all 

genetically engineered (“GE”) ingredients must be included on processed products labels. The 
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United States submitted comments on the notification on September 14, 2011. Peru has not 

responded to the comments. In 2013, Peru renewed efforts to move forward on this proposal.

The United States is concerned that this measure, by requiring mandatory labeling, would suggest 

that GE foods present unique dangers as compared to their conventional counterparts. Moreover, 

the United States is concerned that Peru’s measure might undermine work being undertaken by the 

relevant international body, the Codex Committee on Food Labeling (CCFL). In the CCFL, 

Members agreed to a compendium text that can be used for the development of a labeling policy for 

GE foods, which states it “is not intended to suggest or imply that foods derived from modern 

biotechnology are necessarily different from other foods simply due to their method of production.”

This issue was raised in the WTO TBT Committee by multiple Members, including the United 

States, at the March and June 2013 meetings of the WTO TBT Committee. At the October 2013 

WTO TBT Committee meeting, Peru reiterated that the expected date of publication of the 

regulation had not yet been established.

The United States understands that the measure is currently undergoing an internal review by the 

Peruvian government. The United States is unaware presently whether Peru will allow for public 

comments to be submitted on any revised proposal.

The United States will continue to monitor this issue in 2014.

Russian Federation

The Russian Federation, along with Belarus and Kazakhstan, is a party to the Customs Union (CU) 

and the Eurasian Economic Community (EurAsEC).44 The Eurasian Economic Commission (EEC) 

is the supranational body charged with implementing external trade policy for the CU.45

 Upon 

joining the CU, Russia transferred authority over many aspects of its trade regime to the EEC, 

including technical regulations, standards, and conformity assessment systems. The authority of 

EEC extends to the CU level as well as to the national level. 

Bilateral Engagement 

In 2013, the United States engaged with Russia in the WTO TBT Committee, bilaterally through 

the Business Development and Economic Relations Working Group (BDERWG) established under 

the United States - Russia Bilateral Presidential Commission, and in other fora. The BDERWG is a

forum for the United States and Russia to discuss, inter alia, standards-related regulatory 

cooperation. In 2013 the United States, under the BDERWG framework, held a series of 

 44 Kyrgyzstan and Tajikistan are also members of EurAsEC; Uzbekistan’s membership in the EurAsEC was 

suspended in 2008. 

45 Under the terms of its WTO membership, Russia must ensure that measures taken by the EEC, to the 

extent that they fall within the scope of Russia’s WTO commitments, are consistent with Russia’s WTO 

Obligations.
93

workshops to inform U.S. industry of new opportunities and trade rights stemming from Russia’s 

WTO membership in the area of standards, technical regulations, and conformity assessment. 

These outreach events culminated in a signature event, the United States – Russia Standards Forum 

(Forum) held in Moscow in May 2013. The Forum attracted over 300 participants from both the 

public and private sectors. The participants exchanged best practices and discussed proposals for 

further United States – Russia cooperation to better align standards systems and limit future trade 

barriers.

Bilateral discussions on trade and commercial ties with Russia are now suspended. If 

circumstances change, and if warranted, USTR will reengage in bilateral discussions on TBT issues. 

USTR will continue to ensure Russia's proper implementation of its WTO obligations, including 

with respect to TBT issues.

Transparency

The United States has continued to emphasize to Russia the importance of timely notifications to 

the WTO of draft technical regulations so as to enable other WTO Members to comment on them 

prior to their being finalized. In 2013, its first full year of membership, Russia notified 28 technical 

regulations to the WTO. However, it appears Russia is taking a narrow view regarding the types of 

measures that need to be notified. Consequently, its 28 notifications in 2013 may not reflect the full 

set of technical regulations or conformity assessment procedures that Russia or the EEC proposed 

that year. For example, Russia has not notified its new registration requirements for alcohol 

products. It also has not notified amendments made to its Federal Law on Circulation of Medicines; 

these amendments include a draft law, decree, and registration procedures concerning medical 

devices. Additionally, Russia has failed to notify to the WTO various other measures such as those 

establishing certain technical standards and regulations governing the required installation of 

GLONASS-compatible navigational systems in civil aircraft, as well as revisions to amendments to 

the EEC’s regulations governing food labeling published in October 2012.

In 2013 the United States used a variety of fora to urge Russia to notify proposed technical 

regulations and conformity assessment procedures, including WTO TBT Committee meetings, 

inquiry point requests, and numerous bilateral meetings. To date, Russia has followed up by 

notifying some proposed technical regulations and conformity assessment procedures in a 

reasonable period of time. In addition, the United States has raised concerns about the comment 

periods provided by Russia or the EEC, as appropriate, on draft technical regulations to ensure that 

the United States and interested parties have adequate time to comment. In the second half of 2013 

the United States has seen an improvement in the comment periods listed in Russia’s WTO TBT 

notifications, such that there is usually a 60 day comment period and the date for final comments 

has not already passed when the notification is made. The United States will continue to urge 

Russia at the WTO TBT Committee meetings to identify and use a single inquiry point and to notify 

at an earlier stage proposed technical regulations and conformity assessment procedures (including 

proposed amendments) that may have a significant effect on trade. The United States also 

continues to remind Russia of its obligation to take into account comments submitted by other 
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WTO Members.

Food – Labeling Requirements

On July 1, 2013, new CU labeling requirements, Technical Regulation TR TS 022/2011 titled, 

“Food Product Labeling,” went into effect. These labeling requirements mandate information on 

nutritional components, allergens, and GE foods. In addition, these amended labeling requirements 

require that products containing sweeteners must carry a warning statement that overuse will cause 

digestive problems, and that products with food coloring must declare that the food coloring affects 

a child’s ability to concentrate. Russia did not notify these revisions to the appropriate WTO SPS 

or WTO TBT Committees. While these rules came into effect on July 1, 2013, the EEC has noted 

that it will allow products labeled under the previous regulations to circulate in the market until 

February 15, 2015. The United States sent comments with regard to the proposed revisions to the 

EEC in December 2012. The comments expressed concern that the revised regulations require 

labeling for GE products and nutritional components beyond the recommended guidelines 

established in the Codex General Standard for Food Labeling. Additionally, the United States noted 

that the requirements for the labeling of allergens in food are unclear. The revised regulations do 

not appear to be based on the latest scientific research nor do they appear consistent with the Codex 

General Standard for Food Labeling. The United States has yet to receive a response to its 

December 2012 comments from either Russia or the EEC. Additionally, the United States raised its 

concerns with Russia at the March 2013 WTO TBT Committee. In 2014, the United States will 

continue to engage Russia in the WTO on these and any additional outstanding concerns.

Alcoholic Beverages – Conformity Assessment Procedures, Standards, and Labeling

In December 2012, the Russian government approved Amendment No. 286-FZ which modifies 

Law No. 171 by setting up a new notification procedure for alcoholic beverages. On June 5, 2013, 

Russia’s government adopted the Resolution # 474 “On Submission of Notifications About the 

Beginning of Turnover (sale) of Alcoholic Products on the Territory of the Russian Federation,” 

which implemented the mandatory notification requirements established by Amendment No. 286-

FZ and came into force on October 1, 2013. U.S. industry is concerned that the multiple conformity 

assessment procedures administered by different agencies add an unnecessary level of complexity 

for the sale of alcohol in Russia and are leading to increased costs and time delay.

The CU revised its “Technical Regulation on Alcoholic Product Safety” in November 2012, and 

included some positive changes, including removing a requirement mandating the aging of rums 

and reducing the size of the warning label to allow for other consumer and branding information on 

alcoholic containers.

However, the United States still has significant concerns with the most recent EEC draft of the 

“Technical Regulation on Alcoholic Product Safety,” which is still under discussion within the 

EEC. The most recent draft of this regulation appears to impose duplicative conformity assessment 

procedures, administered by at least three different government authorities, all of which appear to 
95

have the same objective of data registration. Specifically the requirements call for a new alcoholic 

beverage notification procedure to be administered in Russia by the Federal Service for the 

Regulation of the Alcohol Market (FSR). 

The CU “Technical Regulation on Alcoholic Product Safety,” also introduces burdensome and 

unique requirements to label all alcoholic beverages with an expiration date, or include a label 

indicating that “the expiry date is unlimited if the storage conditions are observed.” U.S. industry 

notes that the proposed requirement does not provide accurate or beneficial information for 

products containing more than ten percent alcohol, because these products do not expire. 

Furthermore, the proposed expiration date requirement appears inconsistent with international 

guidelines, particularly with Article 4.71(vi) of the Codex General Standard for the Labeling of 

Prepackaged Foods, which exempts beverages containing ten percent or more by volume of alcohol 

from such date marking requirements. The United States will encourage Russia to eliminate this 

requirement for alcoholic beverages containing more than ten percent alcohol by volume, and urge 

Russia to adopt international standards or guidelines for such products.

The proposed technical regulation gives rise to other issues that could affect U.S. exports of 

alcoholic beverages, including unclear definitions for wine and wine beverages and a requirement 

that whiskey be aged no less than three years. In February 2013, the United States provided 

comments to the EEC and will continue to work with Russia on this matter, in the context of the 

WTO TBT Committee.

Alcoholic Beverages - Warehousing Requirements

Russia maintains a burdensome and non-transparent licensing system for importers of distilled 

spirits. Importers are required to obtain an “activity” license from FSR, which covers wholesale, 

purchasing, supply, and storage of distilled spirits. This process is burdensome and expensive, and 

the license once issued is valid for only five years. The storage requirements for alcoholic 

beverages are set forth in Regulation Order #59. As a result of bilateral discussions that took place 

in 2011, Russia issued a revised regulation in 2012 that went into force in 2013 and which offered 

some improvements. However, issues remain. For example, the United States seeks clarification 

regarding the specificity of warehouse construction requirements, the stringency of warehouse 

inspections, and temperature controls, which appear to exceed international standards. In addition, 

Russian importers of U.S. products have complained in large numbers that FSR is denying their 

applications on spurious grounds apparently to limit the number of importers in this sector. The 

United States provided comments to Russia on the proposed measures in August 2012. As of 

October 2013, the United States has yet to receive a response from either the EEC or Russia 

regarding these comments. The United States also raised concerns in the WTO with Russia about 

these revised requirements during the November 2012 WTO TBT Committee meeting, and urged 

Russia to provide timely and transparent inspections because distilled spirits manufacturers 

continue to experience costly delays awaiting inspection approvals.

Pharmaceuticals
96

In January 2013, Russia released draft amendments to its Federal Law on Circulation of Medicines. 

To date Russia has not notified these amendments to the WTO, and the draft amendments poses 

several potential problems for U.S. industry, many of which stem from a lack of transparency. U.S. 

industry has raised concerns over Russia’s definition of biologicals. U.S. industry reports that 

Russia is moving ahead with the definition despite these concerns. U.S. industry has also raised 

concerns over mandatory testing of clinical trial samples, asserting that Russia’s requirements lack 

clarity and are too vague to implement. Lastly, Russia requires mandatory Russian patient 

participation in clinical trials. These requirements are often onerous for companies to meet, 

especially for drugs for rare medical conditions, where by definition, population samples are low.

Medical Devices

Russia’s Ministry of Health Decree 1416 contains new registration procedures for medical devices, 

which were announced on December 27, 2012 and implemented on January 1, 2013. This time 

period did not provide U.S. industry adequate time to adjust and it contained unique requirements, 

such as Russia’s non-acceptance of international clinical trials. In 2013, the United States made 

several interventions via bilateral meetings and through the TBT Inquiry Point to encourage Russia 

to notify the regulation to the WTO and provide adequate time to comment and to an opportunity 

adjust to the regulation. To date Russia has not responded to these inquiries, or notified the 

regulation to the WTO. During the BDERWG May 2013 Forum, the United States provided U.S. 

industry a platform to discuss this issue directly with the relevant Russian authorities. In the fall of 

2013 Russia appears to have considered U.S. industry inquiries and comments, as evidenced by 

Russia moving back its registration deadline to January 2017. 

Saudi Arabia

Bilateral Engagement

The United States engages with Saudi Arabia on TBT issues in the United States-Saudi Arabia 

Trade and Investment Framework Agreement (TIFA) Council and during WTO TBT Committee

meetings.

Electrical and Electronic Imported Products – Transparency Concerns

On January 1, 2014, the Saudi Standards, Metrology and Quality Organization (SASO), the 

Ministry of Commerce and Industry and the Saudi Customs Authority implemented a new 

conformity assessment program called “Recognition Program on Certificates of Conformity,” 

without notifying the program to the WTO TBT Committee or providing stakeholders notice and 

the opportunity to comment. In the same timeframe that this conformity assessment program was 

adopted, SASO also implemented IEC standards, in place of the standards for electrical products, 

electrical appliances, and information and communication technology developed by the National 

Electrical Manufacturers Association and Underwriters Laboratories, which had previously been 

accepted along with IEC standards. In addition, conformity assessment bodies began requesting 
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more recent test reports, performed anywhere between two weeks to six month prior customs 

clearance for the shipment.

The United States has engaged Saudi Arabia bilaterally on its new conformity assessment program

by sending correspondence to the Governor of SASO in December 2013, conducting bilateral 

meetings in January 2014 in Riyadh, and discussing the issue in the United States-Saudi Arabia 

TIFA Council meetings in April 2014.

In response, SASO has demonstrated a willingness to work with U.S. stakeholders by inviting 

participation in in-country workshops in late January 2014 to outline the requirements of the 

program, providing a copy of the new conformity assessment program in English, and expressing a 

willingness to work through individual company issues if exporters can demonstrate with evidence 

that products have experienced difficulty entering the Saudi Arabia market.

The United States government will continue to encourage Saudi Arabia in 2014 to establish 

transparent processes for stakeholder consultation with respect to this program.

Taiwan

Bilateral Engagement

The United States discusses TBT matters with Taiwan during WTO TBT Committee meetings and 

bilaterally on the margins of these meetings as well as under the auspices of the American Institute 

in Taiwan (AIT) - Taipei Economic and Cultural Representative Office Trade and Investment 

Framework Agreement (TIFA). A TBT working group was established during the March 2013 

TIFA talks. The first TBT Working Group meeting was held in December 2013 to discuss Taiwan’s 

changes to its chemical regulations.

Ceiling Panels – Requirements for Incombustibility Testing Methods

As discussed in the 2013 TBT Report, U.S. companies that manufacture finished interior building 

materials, such as ceiling panels and wood paneling, raised concerns regarding the testing method 

that Taiwan mandates for determining whether those materials meet applicable incombustibility 

requirements. According to U.S. industry, Taiwan’s present measure gives U.S. ceiling tiles a 

lower incombustibility rating than is otherwise warranted and, in some instances, U.S. ceiling tiles 

unreasonably fail the test altogether. The reason the testing is problematic according to U.S. 

industry is that Taiwan’s measure applies a variation of the ISO 5660 standard for Reaction to Fire 

Tests - Heat Release, Smoke Production and Mass Loss Rate, which at the time Taiwan adopted it 

was not complete. U.S. industry notes that a recent revision of the ISO standard incorporated 

additional guidelines that will ensure better and more reliable incombustibility ratings. In October 

2012, USTR urged Taiwan to adopt the ISO committee’s revised standard. At a technical 

discussion hosted by Taiwan officials for industry representatives and experts in September 2013, 

Taiwan told AIT that it would begin recognizing the latest ISO standards related to ceiling panel 
98

incombustibility in October 2013, although the formal announcement has not yet been made.

The United States will continue to monitor this issue in 2014 and press Taiwan to issue measures 

implementing this standard.

Commodity Goods – Labeling Requirements

As discussed in the 2013 TBT report, the United States raised concerns that Taiwan requires all 

“commodity goods” (consumer goods) to be labeled with the manufacturer’s or producer’s name, 

telephone number, and address. This measure imposes costs for firms, including the cost of 

developing unique labeling requirements for the Taiwan market.

In 2013, the United States raised these concerns with Taiwan, including on the margins of WTO 

TBT Committee meetings as well in meetings under the TIFA. 

The United States will continue to monitor this issue in 2014.

Food – Mandatory Biotechnology Labeling

Since January of 2005, Taiwan has required that all food products containing biotechnology

soybean or corn ingredients be labeled as “GMO” or “Containing GMO.” The current labeling 

threshold level is five percent so products that include less biotechnology soybean or corn than that 

threshold do not have to be labeled. The United States is concerned about the requirements’ impact 

on trade, and that they do not appear to be based on science. The United States has additional 

concerns about an amendment to Taiwan’s Act Governing Food Safety and Sanitation that was 

passed by the Legislative Yuan in January 2014. The amendment includes language that could 

require additional biotechnology products to be labeled and instructs Taiwan’s Food and Drug 

Administration (TFDA) to follow EU guidelines when implementing the labeling requirements. 

This is problematic because EU biotechnology regulations have lower threshold levels and do not 

reflect international standards. It is uncertain how this amendment will be implemented, but if 

TFDA enacts regulations in line with European guidelines, the amendment has the potential to 

increase the number of future trade disruptions. The United States will continue to monitor this 

issue in 2014 as Taiwan implements the new amendment.

Cosmetics – Labeling and Other Requirements

Amendments to Taiwan’s Cosmetic Hygiene Control Act are under consideration. It is anticipated 

that after Taiwan’s legislature approves the changes, TFDA will issue draft guidelines that will 

address requirements for product information files, product notification, good manufacture 

practices, product claims, and advertisements.

U.S. industry has expressed concerns that products such as toothpaste and breath fresheners would 

be adversely affected under the amendments. For example, it is concerned that TFDA will require 

that a manufacturer submit ingredient information in a product information file, which would raise 
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issues regarding protection of proprietary information and trade secrets.

The United States will continue to monitor this issue in 2014 as implementing measures become 

available for comment.

Chemical Substances – ECN and NCN Programs

Importers, exporters and traders must register all chemical substances they deal with under the 

Labor Safety and Health Law (LSHL). Taiwan passed amendments to the LSHL in July 2013 but 

has not yet announced implementing regulations. Companies are required to register in order to 

sell, produce, import, or export chemical substances.

Taiwan’s Council of Labor Affairs (CLA) started a pre-registration process in December 2009, the 

voluntary Existing Chemical Substance Nomination (ECN) program. The voluntary program was a 

simpler chemical registration program and ended at the end of 2010. The United States has 

engaged the CLA to make sure no trade secrets or information required by the CLA during the preregistration process would be mishandled or improperly released. Businesses that handle 

chemicals, but failed to register under the ECN before December 31, 2010, are required to register 

those chemicals under a mandatory New Chemical Substance Notification (NCN) program. The 

NCN process is expected to be complex and time-consuming, but is as yet undefined, as the 

amended LSHL does not yet have implementing regulations. CLA may give an adjustment period 

for companies that did not register their substances in the ECN program, but this has not yet been 

decided.

Taiwan notified the WTO in July 2011 regarding the upcoming changes. Additionally, Taiwan’s 

Environment Protection Administration revised the Toxic Chemical Substances Control Act, which 

protects workers in possible harmful environments, and informed the WTO TBT in March 2013. 

As soon as the relevant regulatory changes are made, Taiwan will ban the manufacture, export, 

import, and sale of any chemical substances not listed in Taiwan's chemical inventory under the 

ECN and NCN programs. 

The United States will continue to monitor this issue in 2014 as implementing measures become 

available for comment.

Turkey

Bilateral Engagement

The United States discusses TBT matters with Turkey during, and on the margins of, WTO TBT 

Committee meetings, in meetings of the Council established under the United States – Turkey 

Trade and Investment Framework Agreement (TIFA), in United States – Turkey Economic 

Partnership Commission (EPC) talks, and in the bilateral cabinet-level Framework for Strategic 

Economic and Commercial Cooperation (FSECC). The FSECC is designed to reinforce the work 
100

of the EPC and TIFA and provide political-level guidance on particularly challenging commercial 

and economic issues.

Pharmaceuticals – GMP Decree

In late 2009, Turkey’s Ministry of Health issued a “Regulation to Amend the Regulation on the

Pricing of Medicinal Products for Human Use,” which took effect on March 1, 2010. The 

regulation requires foreign pharmaceutical producers to secure a Good Manufacturing Practice 

(GMP) certificate based on a manufacturing plant inspection by Turkish Ministry of Health (MOH) 

officials, before their products can be authorized for sale in Turkey.

Although it does not oppose MOH inspection requirements for pharmaceutical manufacturing 

facilities, the United States has concerns with respect to certain aspects of this measure. The United 

States is concerned that Turkey no longer accepts USFDA GMP certifications, and that 

pharmaceutical producers face significant delays in meeting the inspection requirements because of 

the MOH’s backlog of GMP inspections. In the February 2013 bilateral TIFA meeting, Turkey 

stated that it would consider amending its regulatory practices in order to allow MOH’s review of 

the pharmaceutical product dossier to take place concurrently with the pharmaceutical producer’s 

process of obtaining GMP certification. This concurrent process has not been implemented yet.

Food and Feed Products – Mandatory Biotechnology Labeling

In 2009, Turkey’s Ministry of Food, Agriculture and Livestock published a regulation governing 

biotechnology in food and feed. The measure was not publicly announced or notified to the WTO in 

advance of entry into force, and contained no phase-in period. Turkey has since published several 

amendments to the regulation and later superseded this regulation with the enactment of the 

“Biosafety Law,” which was notified to the WTO. This law became effective in September 2010 

and mandates the labeling of ingredients derived from biotechnology in all food and feed if the 

biotechnology content exceeds a certain threshold, a requirement that impedes U.S. food and feed 

exports to Turkey. In addition, Turkey’s Biosafety Law goes beyond mandatory method of

production labeling, which refers to the mandatory labeling that a product or ingredient in a product 

was produced using biotechnology. The law requires that “GMO” labels on food contain health 

warnings if the biotechnology food differs from the non-biotechnology food.

This labeling requirement raises additional concerns because it appears to presume, incorrectly, that 

food containing biotechnology products is inherently riskier from a health perspective than its nonbiotechnology food counterpart. Consequently, such health warnings could unnecessarily cause 

public alarm while providing no additional public health protection. For example, changes in edible 

oil composition could lead to health benefits, and the oil could still be as safe for consumption as 

similar oils. Thus, the use of health warnings in the absence of a legitimate health concern could 

misinform the public about food safety.

In addition to the labeling requirement, the Biosafety Law mandates strict traceability for all 
101

movement of biotechnology feed and includes onerous requirements for each handler to maintain 

traceability records for 20 years. The United States has engaged bilaterally with Turkey on the 

margins of the WTO TBT Committee meetings on issues related to Turkey’s Biosafety Law. The 

United States will continue bilateral talks on these issues with Turkey in 2014.

Alcoholic Beverages - Labeling

Turkey notified its draft regulation on alcoholic beverage warning statements to the WTO on 

August 6, 2013, providing a three day comment period. The regulation requires alcoholic 

beverages to carry the warning statement “Alcohol is not your friend.” In the U.S. comments, dated 

August 8, 2013, the United States requested Turkey to explain the rationale requiring this statement. 

Turkey has not yet responded to the U.S. request. The regulation went into effect on January 1, 

2014.

The United States will continue to seek information from Turkey about this labeling requirement in 

2014.
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Appendix A: List of Commenters

1. Almond Board of California

2. American Potato Trade Alliance

3. American Soy Bean Association

4. California Table Grape Commission

5. Grocery Manufacturers of America

6. Herbalife

7. National Confectioners Association

8. National Electrical Manufacturers Association

9. National Fisheries Institute

10. National Milk and U.S. Dairy Export Council

11. National Potato Council

12. North American Export Grain Association

13. Toy Industry Association

14. Underwriters Laboratories

15. U.S. Dairy Export Council & National Milk Producers Federation

16. U.S. Wheat Associates

17. Yum! Restaurants International
103

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

ASEAN Association of Southeast Asian Nations

EU European Union

FTA Free Trade Agreement

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

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

TIFA Trade and Investment Framework ............................

Agreement

TPP Trans-Pacific Partnership

TPSC Trade Policy Staff Committee

T-TIP Trans-Atlantic Trade and Investment Partnership
104

USDA U.S. Department of Agriculture

USITC U.S. International Trade Commission

USTR Office of the United States Trade Representative

WTO World Trade Organization
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE

EXECUTIVE OFFICE OF THE PRESIDENT

WASHINGTON, D.C. 20508