G/TBT/W/411/Rev.1  
13 July 2015  
(15-3625)  Page: 1/4  
Committee on Technical Barriers to Trade  Original: English  
 
  IMPROVING THE UNDERSTANDING OF TH E TRADE ENABLING BENEFITS OF 
REGIONAL AND NATIONAL QUALITY INFRASTRUCTURE  
SEVENTH TRIENNIAL REVIEW 
Submission from the United States 
Revision 
The following submission, dated 10 July 2015, is being circulated at the request of the 
delegation of the United States. 
 
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1  INTRODUCTION 
1.1.  On the occasion of the Seventh Trienni al Review of the World Trade Organization's 
Agreement on Technical Barriers to Trade (TBT Agreement), the United States would like to 
propose examination of a key topic for the effect ive implementation of the TBT Agreement – the 
trade facilitating role that may be realized th rough a National Quality Infrastructure (NQI).  
1.2.  Noting the TBT Agreement recognizes  t h a t  n o  c o u n t r y  s h o u l d  b e  p r e v e n t e d  f r o m  t a k i n g  
measures necessary to ensure the quality of its exports, and that conformity assessment systems 
can improve and facilitate the conduct of international trade. In addition, Articles 2.2 and 5.1.2 require that neither technical regulations nor conformity assessment procedures are prepared, 
adopted or applied with a view to or with the effe ct of creating unnecessary obstacles to trade.  
1.3.  Recalling that the TBT Committee´s Indicative List of Approaches to Facilitate the Results of 
Conformity Assessment
1 includes the use of accreditation to assess the competence of conformity 
assessment bodies, and that in 2009 Members were encouraged to participate in technical 
cooperation activities in the area of conformity assessment consistent with sector-specific national priorities.
2 It also suggests capacity building activities – at the national or regional level as 
appropriate – aimed at improving technical infrastructure (e.g. metrology, testing, certification, 
and accreditation) as well as capacity to enforce (including with respect to market surveillance and 
product liability). 
1.4.  In the Sixth Triennial Review, Members agreed  to continue their exchange of information on 
approaches that may facilitate the acceptance of conformity assessment results, in order to 
contribute to building globally robust and trade facilitative schemes as envisaged under Article 9 of the TBT Agreement.
3 
1.5.  The Agreement focuses on the reduction of unnecessary obstacles to international trade.  
Nevertheless, the United States would like to explore, during the Seventh Triennial Review of the TBT Agreement, how effective and market driven standards and conformity assessment activities 
may be trade enablers. Further discussion of NQI and its relationship to technical regulations, 
                                               
1 G/TBT/1/Rev.12, Annex 1 to Part 1, page 45-46 
2 G/TBT/26, paragraph 59 
3 G/TBT/32, paragraph 5  G/TBT/W/411/Rev.1 
 
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  standards and conformity assessment procedures is merited in order to enhance Member 
implementation of the TBT Agreement. 
1.6.  Manufacturers and producers are obliged to  meet technical regulations and other standards-
related measures and to demonstrate the fulfilment of those requirements. Utilizing approaches to 
facilitate the acceptance of results of conformity assessment in voluntary programs and technical 
regulations is a key market advantage for exports and imports. A National Quality Infrastructure supports these goals. Members, in particular developing country Members, need to be able to 
support manufacturers and producers in understanding and demonstrating compliance with 
technical requirements . 
2  NATIONAL QUALITY INFRASTRUCTURE 2.1.  While there is no agreed definition of Nati onal Quality Infrastructure (NQI), the World Bank 
defines it as the institutional framework that establishes and implements standardization, including 
conformity assessment services, metrology, and accreditation.
4 The Memorandum of 
Understanding (MOU) creating the Quality Infrastructure of the Americas considers the three 
conceptual pillars of a NQI to be standards, a ccreditation, and metrology, particularly because 
regional bodies exist and cooperate in these areas.5  These pillars provide the  services  needed  to 
advance the quality and assure the safety of produc ts placed in national and international markets, 
thus meeting the mandatory technical requirements  that are indispensable for being successful in 
international trade. The definitions of term s discussed as possible components of Quality 
Infrastructure are below and have been defined in the TBT Agreement or have been discussed in 
previous Triennial Reviews.    
2.2.  Standards, as defined by the TBT Agreemen t, are documents 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.  Standards 
may also include or deal exclusively with termin ology, symbols, packaging, marking or labelling 
requirements as they apply to a product, process or production method. 
2.3.  Conformity assessment procedures, as de fined by the TBT Agreement, are any procedure 
used, directly or indirectly, to determine that relevant requirements in technical regulations or 
standards are fulfilled. 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. 
2.4.  Accreditation ensures that the evaluation of  technical requirements by conformity assessment 
bodies is done in a competent and impartial manner, providing confidence that the process to conduct testing, inspection and certification demonstrates conformance to international 
requirements. Accreditation is recognized as a conformity assessment procedure in the definition 
of the TBT Agreement. 
2.5.  Metrology is the science of measurement and its application and includes all theoretical and 
practical aspects of measurements, whatever the measurement uncertainty and field of 
application.6 Legal metrology is the application of legal requirements to measurements and measuring instruments.7 
2.6.  Members need access to NQI services to foster trade, competitiveness, and innovation, as 
well as consumer safety assurances.  These servic es are most useful and best meet the needs of 
international trade when offered by domestic institutions that are internationally recognized.  
                                               
4 Christine Tippmann and Jean-Louis Racine. "T he National Quality Infrastructure: Tool for 
Competitiveness, Trade and Social Well Being", Innovati on, Technology and Entrepre neurship Global Practice 
Brief, March 2013, http://documents.worldbank.org/curated/en/2013/03/20196286/national-quality-
infrastructure-tool-competitiveness-trade-social-well-being  
5 Memorandum of Understanding creating th e Quality Infrastructure of the Americas, 
www.iaac.org.mx/English/Index.php  
6 Defined by the International Vo cabulary of Metrology (VIM3), 
http://www.bipm.org/en/publications/guides/vim.html  
7 Defined by OIML, http://www.oiml.org/en/about/legal-metrology  G/TBT/W/411/Rev.1 
 
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  3  SYSTEMIC ISSUES RELATED TO CONFORMITY ASSESSMENT PROCEDURES AND THE 
RELATIONSHIP TO THE NQI 
3.1.  To better implement technical regulati ons and conformity assessment procedures, more 
robust communication about NQI and regulator under standing of the benefits of using the NQI are 
needed. Identified areas of difficulty and discu ssion of how Members use NQI to improve the 
functioning of technical regulations and conformity assessment procedures may include: 
a. Laws and policies establishing NQI or approach are established without an understanding 
by the country or WTO Member of how they w ill apply to specific technical regulations. 
Even when laws relating to NQI are notified to the TBT Committee, affected stakeholders are unsure of how certain products will be affected because the laws are general and do not specify application to particular products or sectors.  
b. Even when the standards development organizations (SDO) or the National Standards 
Bodies (NSB), the accreditation bodies and the metrology institute of Members are active participants in international conformity assessment and accreditation recognition 
arrangements, the regulatory agencies of Members are often unaware of how to best 
utilize or trust the voluntary arrangements. This leads to practices which create duplicative testing, such as in-country only testing requirements. Or, a Member may 
require a government-to-government Mutual Recognition Agreement (MRA) in addition 
to the voluntary recognition arrangement among accreditation bodies. Discussion of linkages between the NQI and its use in regulatory systems could help reduce duplication and overly restrictive conformity assessment procedures and facilitate trade. 
c. In some situations technical regulations are not specific enough with respect to technical 
requirements or do not incorporate relevant standards.  Technical regulations also may not specify the conformity assessment procedures that are needed for compliance.  
d. More than one regulatory agency, or a regulatory agency and customs authority may 
share authority for the implementation of conformity assessment procedures which can 
lead to a lack of clarity in what is necessary to demonstrate conformity and thus impose 
unnecessary, or duplicative procedures.  
e. Overly restrictive technical regulations that stifle trade. This relates to the situation 
where countries or Members set mandatory standards and conformity assessment procedures for virtually all products in the market that are not justified for reasons of 
health, safety, or environmental protection.   
f. Insufficient regulator understanding of th e level of conformity assessment needed 
relative to the risk level of the product.  This results in mandatory inspection, testing or 
certification requirements for low risk products, which restrict, rather than enable, trade. 
3.2.  These circumstances detract from the impl ementation of Article 6 through 9 of the TBT 
Agreement. Trade can also be hindered or halted, particularly for small businesses and new 
exporters. Application of all the tools in a NQI, particularly those related to participation in 
international and regional systems for conformity assessment, can help facilitate trade of WTO Members. 
4  EXAMPLES OF NQI COOOPERATION 
4.1.  The strengthening of the National Quality In frastructure in the Americas has been recognized 
as an important policy goal.  The Organization of American States (OAS) supported efforts for the creation of a NQI Council to foster competitiveness, innovation, trade, and consumer safety to 
enhance the ability of OAS Member States to have access to internationally recognized quality 
infrastructure services. 
4.2.  The Quality Infrastructure Council of the Am ericas (QICA), which includes the Inter-American 
Accreditation Cooperation (IAAC), Inter-American Metrology System (SIM), and Pan American 
Standards Commission (COPANT) has developed a shared vision and work program and is  G/TBT/W/411/Rev.1 
 
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  promoting a common message to raise awareness of the importance and critical role of NQI in 
national, regional and international competitiveness. 
4.3.  In addition, the Specialized Regional Bodies of the Asia Pacific, including the Pacific Area 
Standards Congress (PASC), Asia Pacific Laborato ry Accreditation Cooperation (APLAC), Pacific 
Accreditation Cooperation (PAC), Asia Pacific Legal Metrology Forum (APLMF), and Asia Pacific 
Metrology Partnership (APMP) work together on mutually beneficial projects, particularly through the Asia Pacific Economic Cooperation Subcommittee on Standards and Conformance (APEC 
SCSC), which provide APEC member support on use of international standards, accreditation 
programs, and projects between metrology organizations, which can contribute to regulator understanding of new or emerging tools or services which can be used to achieve regulatory objectives. The Americas and Asia Pacific cooperative efforts are just two of the many efforts 
happening around the world that would benefit from WTO discussion.  
4.4.  The United States has shared experience with the WTO TBT Committee during the 
October 2013 thematic session on conformity assessment procedures that the National Institute of 
Standards and Technology (NIST) provides consulting services to U.S. regulators on tools they 
may use within the NQI when they are developing  conformity assessment programs or technical 
regulations.
8 In addition, the private sector also offers training and support within the NQI and 
through regional bodies that may provide addition al support to regulators engaged in developing 
voluntary and mandatory requirements.  
5  PROPOSAL 5.1.  Connections between the activities of re gional and national organizations and Member 
regulators are important in the development of NQI and how that infrastructure will affect the 
development and implementation of technical regulations. As a part of the Seventh Triennial Review, the TBT Committee could take stock and discuss relevant national and regional NQI 
activities, including technical assistance activities. In addition, another thematic discussion could 
be held on domestic coordination mechanisms used by experts involved in the development of NQI to convey system improvements an d tools available to regulators to implement NQI into technical 
regulations and conformity assessment procedures .  Members should continue to discuss both 
national and regional NQI activities and experiences in this regard in the WTO TBT Committee. 
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8 RD/TBT/61.