G/TBT/W/531  
 
5 June 2018  
(18-3438) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
APPROACHES TO CONFOR MITY ASSESSMENT  
EIGHTH TRIENNIAL REV IEW 
Submission from the United States  
The following submission, dated 5 June 2018, is being circulated at the request of the delegation 
of the United States  
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1  RESPONSE TO THE EURO PEAN UNION  
1.1.  The United States continues to appreciate the exchange of views taking place in the 8th 
Triennial Review, and we welcome the proposal from the European Union on Approaches to 
Conformity Assessment.1  
1.2.  The United States shares the view of the European Union that conformity assessment 
procedures can be one of the most common and costly non -tariff measures, and that the WTO TBT 
Committee should discuss ways to reduce burdens that can be created by conformity assessment 
procedures . The 2010 -2016 statistic presented by the EU, that 40 % of specific trade concerns 
relate to conformity assessment procedures speaks for itself.  A central priority of the TBT 
Committee is discussion of tools and programs available to Members to ease the exchange of 
information conc erning, and results of, conformity assessment procedures.   
1.3.  The EU 's proposal is to revitalize the Committee 's agreement in the Fifth Triennial Review to 
initiate work on developing practical guidelines on how to choose and design efficient and effective 
mechanisms aimed at strengthening the implementation of the TBT Agreement, including the 
facilitation of acceptance of conformity assessment results .2 Its suggestion to initiate work to 
develop recommendations or practical guidelines to support regulators to  identify elements of 
conformity assessment that they can use in designing the appropriate procedures, reaches to the 
heart of regulatory decision -making to maintain a competitive, open market for products. As long 
as that work is not prescriptive, the Uni ted States can support this proposal moving forward.   
1.4.  The Indicative List of Approaches to Facilitate the Results of Conformity Assessment (the 
Indicative List) is relevant to further work.3 While the Indicative List covers Supplier 's Declaration 
of Confor mity (SDOC) and adequate post market surveillance, which are also, addressed as 
important topics by the EU 's in its proposal, it also covers other areas of conformity assessment. 
Equally important to any discussion of conformity assessment procedures in th e TBT Committee 
are Mutual Recognition Agreements (MRAs), Mutual Recognition Arrangements (MRAs) between 
conformity assessment bodies (CABs), and use of accreditation to qualify conformity assessment 
bodies (CABs), government designation, and unilateral re cognition of conformity assessment 
results.  Each of these elements is necessary for consideration in the development of any guideline.  
1.5.  Two previous US  proposals from the Seventh  Triennial Review are also relevant.  The first 
proposal was to improve the understanding of the trade - enabling benefits of a national quality 
infrastructure (NQI).4 At the conclusion of the Seventh  Triennial Review, Members agreed to 
                                                
1 G/TBT/W/462  
2 G/TBT/26  
3 G/TBT/1/Rev. 13  
4 G/TBT/W/411/Rev.1  G/TBT/W/531  
 
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  discuss approaches to the use of quality infrastructure, both national and regional, for facilit ating 
trade in respect of standards, technical regulations and conformity assessment procedures.5 
Developing countries are actively working to build their NQI; how regulators use NQI in technical 
regulations and mandatory conformity assessment procedures c an either contribute to specific 
trade concerns or help reduce them. This discussion has not yet been conducted in the TBT 
Committee, but would contribute to any Committee efforts to understand how to better utilize 
conformity assessment procedures to meet  our respective regulatory objectives.  
1.6.  The second US proposal called for Members to discuss best practices for notifying regional 
technical regulations.6 The United States continues to see an increase in implementation of 
regional technical regulations an d conformity assessment procedures. Any discussion of facilitating 
the acceptance of conformity assessment results should include a discussion of regional measures 
and WTO Member implementation of them.  
1.7.  In the Seventh  Review, Members also agreed to exchang e information on initiatives of 
Members to enhance regulators ' reliance on international and/or regional systems for conformity 
assessment, including sectoral schemes, aimed at facilitating the recognition of conformity 
assessment results.7 These internati onal and/or regional systems for conformity assessment assist 
in facilitating trade and reduce the cost of conformity assessment to traders.   Members could 
further the discussion on conformity assessment procedures held in March 2016, which focused on 
developments in international and regional systems, and regional trade agreements (RTAs) 
relating to the recognition and acceptance of conformity assessment results.8 
1.8.  The United States sees these three topics -- the implementation of NQI, consideration of 
regional measures, and use of international and/or regional systems of conformity assessment -- as 
integral to the development of a guideline for regulators to assist in the development or design of 
a conformity assessment program.  
2  EXPERIENCE OF THE UN ITED STATE S 
2.1.  The United States is prepared to contribute its experience to this work, as the US National 
Institute of Standards and Technology (NIST) is developing a special publication, "Conformity 
Assessment Considerations for Federal Agencies ".9 The NIST advises a gencies to consider certain 
factors when designing or developing conformity assessment programs central government bodies 
in order to assess the effectiveness of conformity assessment options and determine the type(s) of 
conformity assessment to employ. Th ese may include:  
a. the objective(s) of the underlying regulation;  
b. the level of confidence required by the agency to ensure that the agency objective(s) 
has/have been achieved, weighing the risk of non -compliance and its associated 
consequences with the ant icipated costs of demonstrating compliance (including time 
and resources) to the producers, suppliers, consumers, and the agency;  
c. whether there are existing private sector conformity assessment activities, acceptance 
schemes or arrangements, that may work  in conjunction with or, where appropriate, in 
lieu of governmental conformity assessment activities, except where such activities are 
inconsistent with law, unfit for regulatory purpose, or otherwise impractical;  
d. consistency with statutory national, regi onal and international obligations;  
e. consideration of the available scientific and technical information, as relevant to the 
selection of the appropriate conformity assessment program;  
                                                
5 G/TBT/37, para 3. 9.c 
6 G/TBT/W/415/Rev.1  
7 G/TBT/37, para 3. 9.b 
8 G/TBT/GEN/190  
9 US Federal Register Notice seeking comments on Conformity Assessment Considerations for Federal 
Agencies https://www.federalregister.gov/documents/2017/12/27/2017 -27892/nist -special -publication -2000-
02-conformity -assessment -considerations -for-federal -agencies  
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  f. relevant industry practice and experience, and the industry 's history of compliance;  
g. the need to reduce duplication and complexity, and ensure consistency and coordination 
with the conformity assessment approaches of other agencies, where feasible, 
appropriate, and consistent with law;  
h. the appropriateness of recognizing the results of private sector conformity assessment 
programs being utilized in Member technical regulation, consistent with subsection  c 
(above) ; and  
i. the degree of transparency to stakeholders and the public of the conformity assessment 
activity.  
3  PROPOSAL  
3.1.  In order to initiate work to develop recommendations or practical guidelines to support 
regulators ' use of trade facilitative conformity assessment procedures when designing the 
appropriate technical regulations or mandatory programs, the Committee should consider these 
elements for thematic discussion, along with the development of practical guidelines :  
a. Exchange information on the development of NQI, including the development of systems 
for standardization, conformity assessment, and metrology. Those systems underpin the 
regulatory system of a Member and strengthen the regulator 's ability to implement and 
enforce technical regulations  and conformity assessment procedures . 
b. Exchange information on initiatives of Members to enhance regulators ' reliance on 
international and/or regional systems for conformity assessment, including sectoral 
schemes, aimed at facilitating the recognition of conformity assessment results.  The 
thematic discussion should include what barriers or weaknesses within the system 
prevent regulators ' use of these tools at a national or regional level.  
c. Exchange information of national WT O Member experiences on considerations used in 
the development of conformity assessment programs, including the role of agencies or 
ministries that may serve as advisors to regulatory agencies when developing such 
programs.  
 
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