WORLD TRADE  
ORGANIZATION   
G/TBT/W/341 
13 September 2011 
 (11-4394) 
Committee on Technical Barriers to Trade  
 
 
 
COMPILATION OF SOURCES ON GOOD REGULATORY PRACTICE 
 
Background Note by the Secretariat1 
 
 
At the Fifth Triennial Review of the WTO Agreement on Technical Barriers to Trade 
(hereafter "the TBT Agreement"), in  November 2009, delegations agreed inter alia  to compile a list of 
guidelines for Good Regulatory Practice taking in to account Members' experiences and existing 
relevant work of other organizations.2   The present note is intended to compile a first, non-exhaustive 
list of sources on Good Regulatory Practice, including – where they exist – guidelines.  It also contains summarized information drawn from Member s' submissions and discussions to date in the 
TBT Committee on the subject of Good Regulatory Practice.   
Members are invited to provide further inputs to this note, including by identifying other 
relevant references (Section 2) and/or by up dating the summarized information in Section 3.
3 
_______________ 
I. INTRODUCTION 
1. There has been considerable information ex change on Good Regulatory Practice in the WTO 
TBT Committee.  The subject has been addressed in all five triennial reviews of the TBT Agreement 
and discussed at a Workshop on Good Regulatory Practice held on 18-19 March 2008.4  In addition, 
background information has been provided in three notes by the Secretariat, including a recent one on 
regulatory cooperation between Members.5 
2. In the context of TBT Committee discussions, G ood Regulatory Practice is used to describe 
the practical implementation of the TBT Agreement.  The emphasis is on how best to implement the 
provisions of the Agreement to achieve a particul ar policy objective.  Effective implementation 
through best practices is seen as an important  means to avoid unnecessary obstacles to trade. 
3. Multilateral efforts to address governments' regulat ory policies are not limited in relevance to 
the TBT Agreement, or even to internati onal trade.  Indeed, "regulatory reform"6 - which applies in 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. 
2 G/TBT/26, para 11(a).  
3 Such information may be communicated to the WTO Secretariat by e-mail to Ms Una Flanagan 
(una.flanagan@wto.org). 
4 A Summary Report of the WTO TBT Workshop on Good Regulatory Practice is contained in 
document G/TBT/W/287.  
5 Background note for the preparation of the Fourth Triennial Review (JOB(05)/107, 14 June 2005),  
Good Regulatory Practice (JOB(08)/7, 22 February 2008), and Regulatory Cooperation Between Members 
(JOB/TBT/10, 18 May 2011), respectively. 
6 The OECD defines this concept as "Changes that improve regulatory quality, that is, enhance the 
performance, cost-effectiveness, or legal quality of regulations and related government formalities.  This term 
can mean: revision of a single regulation, the scrapping and rebuilding of an entire regulatory regime and its G/TBT/W/341 
Page 2  
 
  connection with the Committee's discussions of Good  Regulatory Practice - is a wide-ranging concept 
that relates to many areas where governments regula te, including, for instance, efforts to combat 
corruption.  So as not to a priori  exclude information that may be of  use to delegations in the specific 
WTO TBT Committee context, the sources listed below ma y also cover areas that are relevant - in this 
broad sense - to regulatory reform. 
II. ORGANIZATIONS 
APEC APEC has played a strong role in promoting the use of good regulatory practices 
since 1989.  Two committees within APEC have been important in this respect.  The 
Economic Committee of APEC works on identifying the principles and procedures constituting GRP.  In addition, the Committee on Trade and Investment Subcommittee on Standards and Conformance analyses the role of GRP in strengthening the implementation of WTO rules and in the reduction of unnecessary 
barriers to trade.  The following illustr ate some other significant milestones in 
APEC's work on GRP: 
1999: APEC Leaders' endorsement of the APEC Principles to Enhance Competition 
and Regulatory Reform highlighted the importance of concepts such as non-
discrimination, transparency, and account ability in developing and implementing 
regulations.   
2000: APEC members endorsed the APEC-OECD Cooperative Initiative on 
Regulatory Reform.  It was recognized in th is context that regulatory reform is a 
central element in the promotion of open and competitive markets, and a key driver 
of economic efficiency and consumer welfare. 
2001: The SCSC was directed by the Osak a Action Agenda to implement initiatives 
aimed at improving regulatory programs and standards development processes, as 
well as at promoting more transparent and better aligned voluntary and mandatory 
standards. 
2004: The Leaders' Statement to Implement APEC Transparency Standards laid down 
guidelines aimed at enhancing openness, acces sibility, and participation with respect 
to laws, regulations, and rulings.  
2005: APEC's endorsement of the APEC-O ECD Integrated Checklist on Regulatory 
Reform – a policy tool for self-assessment , integrating questions about regulatory 
quality, competition policy, and market openness.  The APEC Competition Policy 
and Deregulation Group and the OECD Horizontal Programme on Regulatory 
Reform cooperated closely in the preparation of this checklist.  
2011: SCSC's 6
th Conference on Good Regulatory Practice was held in Washington 
DC.  The conference reviewed the expe riences of different countries with the 
implementation of GRP, to allow an exchange of ideas, and encourage fresh 
perspectives aimed at pushing forward the GRP mandate.  SCSC members also 
agreed that the information from the Conference would be used to respond to the SCSC's mandate, as indicated in the 2009 re vision to the SCSC Terms of Reference 
to update and revise the SCSC's "Informa tion Notes on Good Practice for Technical 
Regulation (2000)," "Guidelines for the Pr eparation, Adoption and Review of 
Technical Regulation (1996)," and "Principles and Features of Good Practice for 
Technical Regulation (2000).  "http://www.apec.org/Home/Groups/Committee-on-
Trade-and-Investment/Sub-Committee-on-Standards-and-Conformance"  
                                                                                                                                                                     
institutions, or improvement of processes for making re gulations and managing reform". Regulatory Reform: A 
Synthesis, OECD, Paris, 1997, page 6 (Box 1).  G/TBT/W/341 
 Page 3 
 
 
  2011 6th Conference on Good Regulatory Practice 
http://aimp.apec.org/MDDB/Pages/sear ch.aspx?setting=ListMeeting&Date
Range=2011/03/01%2C2011/03/end&Na me=6th%20Conference%20on%2
0Good%20Regulatory%20Practice%202011  
2005 APEC-OECD Integrated Checklist on Regulatory Reform 
http://www.oecd.org/datao ecd/41/9/34989455.pdf  
2000 Information Notes on Good Practice for Technical Regulation 
http://www.jisc.go.jp/eng/apec-asem/pdf/grp_info.pdf  
 
ASEAN The promotion of Good Regulatory Practic e is an integral part of the work 
programme of ASEAN Consultative Committee on Standards & Quality (ACCSQ).  The Committee seeks to improve the consistency and transparency of technical regulations, thereby reducing unnecessary obstacles to trade.    
Information about the work of ASEAN on Good Regulatory Practice can be found at: 
http://www.aseansec.org/4951.htm  
2009 ASEAN Good Regulatory Practice (GRP) Guide 
http://www.aseansec.org/22487.pdf  
2005 ASEAN Policy Guideline on Standards and Conformance  
http://www.aseansec.org/20531.pdf  
 
OECD The OECD Programme for Regulatory Reform  aims at helping governments improve 
regulatory quality.  The Programme target s the reform of regulations that raise 
unnecessary obstacles to competition, innovation and growth, while ensuring that regulations efficiently serve important social objectives.  The objective of this programme is promoted in four ways:  policy recommendations, country reviews
7, 
thematic discussions, and coopera tion with non-member countries. 
For more information on OECD's work with respect to regulatory reform see: 
http://www.oecd.org/topic/0,3373, en_2649_37421_1_ 1_1_1_37421,00.html  
2009 Indicators of Regulatory Management Systems, 2009 Report, Regulatory 
Policy Committee http://www.oecd.org/dataoecd/44/37/44294427.pdf 
2009 Regulatory Impact Analysis: A Tool for Policy Coherence, OECD 
Publishing, Paris. http://www.keepeek.com/Digital-Asset-
Management/oecd/governance/regulatory-impact-
analysis_9789264067110-en  
2005 Guiding Principles for Regulatory Quality and Performance 
http://www.oecd.org/dataoecd/19/51/37318586.pdf  
1997 Recommendation of the Council of the OECD on Improving the Quality of 
Government Regulation, including the OECD Reference Checklist for 
Regulatory Decision-Making and Background Note http://www.oecd.org/dataoecd/17/25/2391768.pdf  
                                                      
7 To date, 23 reviews of OECD members have been completed as well as 3 reviews of non-members: 
Russia (2005), Brazil (2008), China (2009). G/TBT/W/341 
Page 4  
 
  1995 Recommendations for Improving the Quality of Government Regulation 
"http://www.oecd.org/officialdocuments /displaydocumentpdf?cote=OCDE/
GD(95)95&doclanguage=en%20"  
 
UNECE The UNECE Working Party on Regulatory Cooperation and Standardization Policies 
(Working Party 6) is an intergovernmental group of experts that elaborates 
recommendations and good practices on a va riety of policy matters relating to 
technical regulations; standardization; c onformity assessment (testing, certification, 
inspection, etc.); accreditation; mark et surveillance; quality/environmental 
management systems and metrology.  The Working Party is open to all UN member 
States as well as intergovernmental organi zations and non-governmental organization 
recognized by the United Nations Economic and Social Council (ECOSOC).  Private 
sector representatives may also participate if  nominated by a member State Head of 
Delegation or at the invitation of the secretariat.  
More information about UNECE's work on Good Regulatory Practice can be found at:  http://www.unece.org/ . 
2009 What UNECE does for you  UNECE works for better and convergent 
regulations - http://www.unece.org/trade/wp6/AreasOfWork/RegulatoryCooperation/Reg
ulatoryCooperation-Brochure.pdf  
2009 A Common Regulatory Language for Trade and Development  
http://www.unece.org/publications/oes/T RADE.CommonRegulat oryTradeDev.E.pdf  
 
World 
Bank The Better Regulation for Growth  Program is an initiative of the Investment Climate 
Advisory Services of the World Bank (in partnership with UK Department for International Development and the Dutch Mini stry of Foreign Affairs).  It develops 
guidance and tools to assist developing countries in undertaking regulatory reform 
programs.  In particular, the progra m is aimed at improving regulatory and 
investment environments in developing countries, towards the achievement of 
economic growth, private investment and poverty reduction. A core element of the 
program is the compilation of experiences and lessons from regulatory governance initiatives in developing countries, so as to better inform future reform efforts. The 
program also seeks to adapt and implement existing best practices for regulatory reform, such as the OCED regulatory reform agenda, to developing country contexts. 
For example, one study sought to adapt OECD best practice on Regulatory Impact 
Assessment (RIA) to meet the needs and c onstraints of developing countries, creating 
the so-called 'RIA Light' approach.  A num ber of policy papers and guidelines (on 
regulatory quality indicators, RIA and other regulatory review mechanisms), as well as regulatory reform case studies have been prepared under this program. 
More information on this work, and othe r relevant materials, can be found at: 
"https://www.wbginvestmentclimate.org/advisory-services/regulatory-
simplification/business-regulation/be tter-regulation-for-growth/brg.cfm"   G/TBT/W/341 
 Page 5 
 
 
   2010 Regulatory Quality Indicators 
"https://www.wbginvestmentclimate.or g/uploads/OverviewRegulatoryQuali
tyIndicators.pdf"  
 2010 Making it Work: 'RIA Light' for Developing Countries 
http://www.wbginvestmentclimate.org/uploads/RIALightNov2009.pdf  
 2010 Tools and Approaches to Review Existing Regulations 
https://www.wbginvestmentclimate.org/uploads/BRGTools.pdf  
 2010 Regulatory Governance in Developing Countries 
"https://www.wbginvestmentclimate.org/uploads/RegulatoryGovinDevCou
ntries.pdf"  
 2009 Lessons for Reformers: How to La unch, Implement and Sustain Regulatory 
Reform "http://www.ifc.org/ifcext/fias.nsf/AttachmentsByTitle/FIAS_CaseStudies_
Lessonsforreformers/$FILE/Lessonsforreformers.pdf"  
 2008 Project-Level Indicators 
https://www.wbginvestmentclimate.org/uploads/ProjectLevelIndicators.pdf  
 
 
III. MEMBERS 
4. The following tables set out selected information submitted by Members on Good Regulatory 
Practice in the TBT Committee.  Key elements are su mmarized in bullet form in the tables below.  
Information is listed alphabetically  and in reverse chronological order (most recent first).   
5. In summary, Members have stressed: 
(a) the fundamental importance of transparency and accountability in the development of 
regulations, and the need for incl usiveness in consultation processes; 
(b) the importance of internal/domestic c ooperation, using a "whole-of-government" 
approach; 
(c) the importance of analysis and review and the consideration of alternative measures, 
including the option not to regulate; 
(d) the merits of the use of RIAs to facilitate regulatory decision-making; 
(e) the benefits of a responsive regulatory system, including the capacity to detect 
emerging issues; 
(f) the advantages of performance-based regulation; 
(g) the importance of simplicity in regulation; 
(h) that GRP is an important component of capacity-building initiatives; 
(i) that the preparation of a "guide" on GRP c ould be particularly helpful for developing 
countries; and 
(j) that regulatory cooperation between Member s is an important component of GRP. G/TBT/W/341 
Page 6  
 
   
Brazil  Effectiveness:  Regulations need to be legally, politically, 
economically, and socially robust, to be effective.  They must be in line with the law, and must account for the socio-economic and environmental aspects of their impact on society. The effectiveness of the regulation is also impacted by its rationality, in that it must be based on scientific grounds, and must  stay within the bounds of 
meeting needs of society. It should also be implemented at a level as 
close as possible to the citizens.  
 Impartiality:  Technical regulations must be impartial, clear, and 
expressed in a language accessible to all. The application of regulations must also be impartial,  and similar situations must be 
treated similarly. 
 Morality:  Regulations must be based on  and guided by public moral 
principles, and should respect the commitment of the government, as 
well as bilateral and multilateral international agreements. They 
should respect principles of competition, fair trade and investment facilitation.  
 Transparency:  Regulations must be transparent, and participation of 
all stakeholders must be ensured.   
2008 The Brazilian Guide on Good Regulatory Practices 
http://www.inmetro.gov.br/qualidade/pdf/guia_ingles.pdf 
2008 Boas Práticas Regulatórias: Guia  para o Programa de Melhoria do 
Processo de Regulamentação da Anvisa http://www.anvisa.gov.br/institucional/anvisa/pmr/GuiaBPReg.pdf  
 
 
Canada  Performance-based regulation :  Performance-based regulation sets 
the objective to be met (by the me asure) rather than prescribing the 
means to achieve it.  There should be a focus on achieving a desired outcome, rather than assuming that a particular instrument, for example a law or regulation, is the most appropriate means to achieve 
it.  
 Evidence -based regulation : Cost-benefit, risk analysis and 
performance measurement and evalua tion result in better regulations. 
Added rigor and discipline to the analysis will promote more effective and efficient regulations. 
 Regulatory Impact Assessments (RIAs): An RIA is a practical tool to 
facilitate regulatory decision making, emphasizing desired objectives. 
 Regulatory Cooperation:  Regulatory cooperation has improved the 
identification of alternative approaches to addressing common problems and objectives. 
 Capacity building :  Good Regulatory Practic e may be an important 
component of capacity building initiatives, particularly with respect to systems for regulatory review.   G/TBT/W/341 
 Page 7 
 
 
  November 2007 Canada – Costa Rica Compe titiveness Development Fund Projects National 
Quality System of Costa Rica 
G/TBT/W/283 (joint submission with Costa Rica) 
March 2006 Advancing the Discussion of Instrument Choice under Good Regulatory 
Practice  G/TBT/W/264  
June 1998 National Experiences with Technical Regulations  
G/TBT/W/71 
On-going Work Extensive regulatory guidance and support documents including but not 
limited to the Cabinet Directive on Streamlining Regulations (CDSR) , Triage 
Statements , Regulatory Impact Analysis Statement (RIAS)  and the Canadian 
Cost-Benefit Analysis Guide   www.regulation.gc.ca 
 
Colombia  Regulatory Impact Assessment (RIAs):   Regulation should be 
adopted, when necessary, solely on th e basis of the risk associated 
with the products, and should be in  conformity with international 
standards. Assessment of the impact of regulation is one of the key 
elements of achieving efficient and effective regulation.  
 Equivalence: Mutual adjustment may be facilitated by a procedure 
that facilitates equivalence of re gulations between WTO Member, or, 
if that is not possible, a procedure that can shed light on the differences in regulatory processes.   
 Regional cooperation : Cooperation in the area of standardisation at 
the regional level (in Colombia's  case the Andean Community) may 
enable achievement of equivalen ce of certain voluntary standards, 
which can be used as a starting point for developing technical regulations. 
October 2006 Fourth Triennial Review of the Operation and Implementation of the 
Agreement on Technical Barriers to Trade  G/TBT/W/269 
June 2004 Colombia's Experience with Good Regulatory practice 
G/TBT/W/239 
 
Costa Rica  Examining the costs of alternative measures :  Evaluating countries' 
regulations means examining possible alternatives. A complete 
evaluation involves the examination of potential costs and 
consequences of each alternative,  for both the country issuing the 
regulation as well as the countries which would have to comply with it. When assessing the costs and consequences of a regulation two main types of costs should be considered: the cost of complying with the regulation, and the cost of demonstrating compliance with the regulation. Often the latter exceeds the former. 
 Capacity building :  Good Regulatory Practic e may be an important 
component of capacity building initiatives, particularly with respect G/TBT/W/341 
Page 8  
 
  to systems for regulatory review.  
November 2007 Canada – Costa Rica Compe titiveness Development Fund Projects National 
Quality System of Costa Rica  
G/TBT/W/283 (joint submission with Canada) 
June 2006 Fourth Triennial Review of the Operation and Implementation of the 
Agreement on Technical Barriers to Trade 
G/TBT/W/266 
  
European Union  Performance-based regulation:   Performance based regulation is 
more easily adaptable and encourages innovation. 
 Proportionality, effectiveness, necessity:   The process of formulation 
of regulations should ensure that  while regulations might serve 
legitimate ends, regulation should not be more trade-restrictive than 
necessary to achieve set objectives.  The principle of proportionality 
should ensure that the necessity an d effectiveness of the measures is 
weighed against the objective pursued.   
 Better Regulation / simplification: Better regulation includes 
simplifying existing regulations, e nhancing the preparatory process 
for new regulations, and efforts at reducing regulatory burden.  
 Regulatory Cooperation:  Regulatory cooperation between countries 
can be viewed as an element of Good Regulatory Practice.  It can help avoid unnecessary obstacles to trade and ensure that measures 
are not more trade restrictive than necessary.   
 Regulatory Impact Assessment (RIAs):  An RIA is an important tool 
to evaluate the potential economic, social and environmental implications of regulation, as well as to screen regulations for 
potential competitiveness and competition impacts. RIAs should also 
seek to simplify regulation, wherever possible, and include an analysis of the option of not regulating.  
2011 
(Regularly updated ) Better Regulation in the European Union 
http://ec.europa.eu/governance/better_regulation/index_en.htm  
(Thematic website providing comprehens ive information and links to all 
regulatory and policy documents as we ll as any studies produced by or on 
behalf of the European Commission in the Better Regulation field)  
2010 European Commission Communication "Smart Regulation in the European 
Union" (COM(2010)543 final) 
"http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0543:FIN:EN:PDF"  
2009 Third Strategic Review of Better Regulation in the European Union 
(COM(2009) 15 final) 
"http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0015:FIN:EN:PDF" 
European Commission Guidelines for carrying out impact assessments 
"http://ec.europa.eu/governance/impact/commission_guidelines/commission_
guidelines_en.htm"  
2005 Good Regulatory Practice  G/TBT/W/341 
 Page 9 
 
 
  G/TBT/W/254  
2003 Recent European Commission Developments in the Field of Better  
Regulation  
G/TBT/W/219 
2002 A Policy Framework for the Facilitation of Trade in the Fields of 
Standardization and Conformity Assessment: A toolbox of Instruments  
G/TBT/W/173/Add.1 
  
Hong Kong, 
China  Equivalency: Hong Kong, China used examples of standards in the 
area of toys and children's products  to illustrate how an effective 
implementation of the equivalency principle may facilitate trade.    
November 2000 Equivalency Experience Paper – Toys and Children's Products  Safety 
Ordinance G/TBT/W/148 
 
Mexico  Preparation of a Guide : Some market access challenges result from 
incorrect implementation of the s ubstantive obligations laid down 
within the TBT Agreement. One solution to this issue could be the preparation of a Guide to Good Regulatory Practice, which would allow Members to assess, in adva nce, the extent to which their 
regulations would meet obligations under the TBT Agreement.  This 
could be particularly helpfu l for developing countries. 
 Representativeness and consensus :  Sectors that are considered to be 
affected by the application of t echnical standards and regulations, 
both within and outside the count ry, should participate in their 
drafting and eventual amendment.   
 Transparency : In the interest of transparency and ease of access to 
regulations, it should be ensured that any interested party is able to access the content of the draft as well as final versions of the documents in question. All subjects covered by technical regulations should be published in one place and this publication should be 
notified to the TBT Committee. 
 Analysis and review : Efforts should be made to ensure that 
regulations are not more trade restrictive than necessary to ensure the fulfilment of the desired legitimate objective.  This requires analysis 
of economic and social impacts of the regulations, as well as periodic 
review. 
 Rationale : In order to ensure that technical regulations are no more 
trade restrictive than necessary, it is important to prepare regulatory impact assessments (RIAs) with a view to carrying out a legal, 
economic and social study of the regul ation that is to be published. 
 Harmonization : Technical regulations and standards are expected to 
be consistent with international st andards, or the relevant parts of 
international standards, except wh ere they do not constitute an 
efficient or suitable means to achieve the legitimate objective sought. G/TBT/W/341 
Page 10  
 
  June 2009 Fifth Triennial Review of the Agreement on Technical Barriers to Trade 
G/TBT/W/313 
November 2004 Good Regulatory Practice 
G/TBT/W/248 
May 2003 Third Triennial Review of the Agreement on Technical Barriers to Trade 
G/TBT/W/209 
 
New Zealand  Responsiveness: A cost effective and responsive regulatory system 
anticipates future problems and opportunities and adapts quickly and 
effectively.  This requires a system that has the capacity to detect and 
analyse emerging issues.  
 Internal coordination:  Internal coordination is critical as Members 
seek to effectively implement GRP principles and to meet their international obligations.  Furtherm ore, it is an essential basis for 
successful international regulator y cooperation.  New Zealand's 
"Regulatory Forum" is a model for regulatory coordination among 
domestic administrative entities.  It promotes better alignment between regulators, infrastructure bodies, and policy makers, allowing for a "whole-of-government" approach to Good Regulatory Practice.  
 Problem identification : The first step in the development process for 
technical regulations should be to clearly identify the problem that 
needs to be addressed.  Accurate problem definition reduces the risk 
of choosing inappropriate options for government action or ignoring 
more effective solutions, and reduces the likelihood of over-regulating. 
 Consideration of alternatives: In order to ensure that government 
intervention meets the TBT objectiv e of good regulation design, it is 
important that all feasible options are identified and assessed.   
 Transparency:  The process of developing technical regulations 
should be as transparent as possible.   
2011 Good Regulatory Practice 
Submitted by New Zealand at the 6th APEC Conference on Good Regulatory 
Practice 
http://aimp.apec.org/Documents/2011/SCSC/CON1/11_scsc_con1_003.pdf  
2009 Fifth Triennial Review of the Operation and Implementation of the 
Agreement on Technical Barriers to Trade  
Comments on the Proposals Discussed at the 25-26 June 2009 Committee 
Meeting JOB(09)/74  
2008 The Regulators' Forum: A New Zealand Example of Domestic Regulatory 
Coordination 
G/TBT/W/294 
1997 Requirements of the Agreement on Technical Barriers to Trade Concerning 
the Preparation, Adoption, and Re view of Technical Regulations 
Communication from New Zealand - G/TBT/W/44  G/TBT/W/341 
 Page 11 
 
 
   
Uganda  Guide to Good Regulation:   Good regulation is about providing 
proper protection without imposing ha rmful unintended side effects. 
It is also about motivating inn ovation, growth, formalization and 
improvement in business performance, by reducing the cost of doing business and creating an environment attractive to private investment. 
 Key Questions to ask when considering to regulate:  
o What is the problem or the risk that you are trying to address? 
o Whom does the problem or issue affect? 
o Do you have a good reliable da ta to show how serious and 
widespread the problem is/how serious the risk is that is being dealt with? 
o Can the government realistically solve the problem? 
o What would happen if no action were taken? What would be 
the risk? 
o What outcome do you want - are you sure you will achieve this 
by regulating? 
o What actions other than regulation might be effective? 
o How will firms - especially small firms, government 
departments, poorer people and the environment – be affected by the proposed regulation? 
o How would the regulation be managed and enforced in this 
case? If enforcement looks overly difficult or costly, are other 
options preferable? 
o How would other potential options  be managed and resourced? 
o Is the kind of regulation envisaged  consistent with international 
commitments? 
 Understanding the issue and defining the problem:  Problem 
definition must contain an explan ation supported by evidence of how 
serious and widespread the problem is, why the problem has arisen 
and how the proposed regulation will solve it. 
 Risk Assessment:  Identify how serious is the danger you are dealing 
with. Risk assessment helps to understand what the various risks 
associated with a particular situation are, what controls may be necessary and what form they should take. 
 Consideration of Alternatives: For any problem, there will be a range 
of possible solutions. Making a new law may be one of the solutions, 
but may not necessary be the best. Alternatives to regulating may 
include, inter alia : retaining the status quo; reviewing existing 
regulations; improving information and education; introduction of 
voluntary schemes, guidelines or cod es of practice; self-regulation; 
using economic incentives or disincentives; and using risk-based 
insurance or risk pricing.  G/TBT/W/341 
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   Core Themes for Designing Effective Regulations: Simplicity and 
transparency; avoidance of placing unnecessary burdens on 
businesses; use of goal-based regulations wherever possible; public 
accountability; and balancing risk, cost and practical benefit.  
 Regulatory Impact Assessment: An analysis of the likely benefits and 
costs associated with the introduction of a new policy or regulatory proposal helps to understand the fu ll consequences of the regulations 
on society. By identifying who wins and by how much, and who 
loses and by how much, it is possible to predict the sorts of decisions 
that people will likely make when faced with the new law, and the roll-on effects of those decisions. It will also be possible know whether particular groups are likely to be disproportionately or unfairly affected.  
 
United States  Transparency and Accountability.  Openness, transparency and 
accountability in the design and application of regulations are fundamental to ensuring public confidence in the approach taken to address a particular problem identified.   
 Coordination:  The development and application of technical 
regulations and associated conformity assessment requirements often falls within the purview of a broad range of regulatory agencies.  Regulatory coordination and cooperation in ensuring Good Regulatory Practice and adherence to  TBT obligations is important. 
Mechanisms for intra-governmental coordination and interface with 
relevant non-governmental parties are essential.   
 "Internalizing"  TBT obligations:  To ensure domestic compliance 
with the Agreement's obligations, a Member would likely need a law, 
policy, or another administrative mechanism to provide practical 
guidance to ensure all agencies "i nternalize" TBT obligations when 
designing, revising, or applying technical regulations and associated 
conformance requirements.    
 Establishing the need to regulate:  Open and transparent processes for 
examining the need for regulation leads to better decisions.  Well-
done analyses are valuable tools in the decision-making process.  
Such processes, if used correctly, will enhance participation by the public and other governments, and regulations will be less likely to create unnecessary trade barriers. 
2011 Regulatory Strategy: Executive Order 13563, of the US President 
"http://www.whitehouse.gov/the-press-offi ce/2011/01/18/improving-regulation-and-
regulatory-review-executive-order"  
Remarks by Mr Cass R. Sunstein, Administrator, U.S. Office of the 
Information and Regulatory Affairs (OIRA), Office of Management and 
Budget (OMB), on the subject of "Regulation". 
"http://www.whitehous e.gov/sites/default/files/omb /inforeg/speeches/economic-
growth-public-protection-03152011.pdf"  
2009 Good Regulatory Practice:   The Role of Strong Central Government 
Coordination in TBT Agreement Implementation 
US recommendations for the Fifth Triennial Review 
G/TBT/W/315  G/TBT/W/341 
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  2008 
 Determining the Need to Regulate 
Communication from  the United States on key features of their regulatory process 
G/TBT/W/285 
2005 Good Regulatory Practice 
G/TBT/W/258 
2003 
 Third Triennial Review of the TBT Agreement 
Submission in context of Third Triennial Review 
G/TBT/W/220  
2001 
 Labelling   
Good regulatory practice as applied to labelling 
G/TBT/W/165 
 
Other papers of specific relevance to GRP 
Brazil 
 Good Regulatory Practice – National Experiences 
G/TBT/W/267, June 2006 
Chile 
 Competition Policy and Deregula tion Meetings – APEC 2004 
JOB(04)/163, November 2004 
Japan 
 The Introduction of Discussions on Good Regulatory Practice in APEC  
G/TBT/W/223, July 2003 
  
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