WORLD TRADE  
ORGANIZATION  G/TBT/W/315 
10 June 2009 
 (09-2789) 
Committee on Technical Barriers to Trade Original:   English 
  
 
GOOD REGULATORY PRACTICE:  THE ROLE OF STRONG CENTRAL GOVERNMENT 
COORDINATION IN TBT AGREEMENT IMPLEMENTATION 
 
Communication from the United States
 
 
 
 The following communication, dated 9 June 2009, is being circulated at the request of the 
delegation of the United States . 
 
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I. INTRODUCTION 
1. In its 28 October 2008 submission to the WT O Committee on Technical Barriers to Trade, 
New Zealand outlined its experien ce with its new model for domest ic regulatory cooperation, the 
Regulators’ Forum, which aims to promote bette r alignment and coordination across regulators, 
policy makers, and infrastructure bodies with a view to achieving good regulatory practice.1  T h e  
experiences of New Zealand and the United States2 demonstrate that there is no "one size fits all" 
approach to creating greater coordination among re gulators.  The United States found the description 
of New Zealand’s approach to be very useful a nd agrees that "continual sharing of information on 
different models of regulat ory cooperation can benefit all Members of the Committee." 
2. The United States notes that, in the Fourth Tr iennial Review, the Committee emphasized "the 
benefits of simplifying and impr oving regulatory environments and emphasizes the need for openness, 
transparency, and accountability in the development and application of tec hnical regulations and 
conformity assessment procedures".3  The Committee also recognized "the usefulness of a Member 
establishing administrative mechanisms for coordina tion between competent authorities," noted that 
"a number of Members have set up TBT coordina ting committees to facilitate communication and 
cooperation between relevant government authorities, " and stressed "the importance of including local 
governments as well as non-governmental parti es in the domestic consultation activities."4  
Consequently, the Committee agr eed to share experiences on, inter alia , "how good regulatory 
practices have been integrated into Members’ re gulatory structures, including the use of mechanisms 
to ensure openness, transparency and account ability of the regulatory processes" and "the 
establishment of domestic administrative mechan isms to facilitate coope ration and coordination 
between competent authorities and c oordination with other stakeholders".5 
                                                      
1 Committee on Technical Barriers to Trade, “The  Regulators’ Forum: A New Zealand Example of 
Domestic Regulatory Coordination," G/TBT/W/294, 28 October  2009. 
2 The United States has previously submitted two GRP experience papers: G/TBT/W/220, 30 June 
2003 and G/TBT/W/258, 26 October 2005, as well as a paper on "Determining the Need to Regulate," G/TBT/W/285, 19 March 2008. 
3 Fourth Triennial Review of the Operation an d Implementation of the Agreement on Technical 
Barriers to Trade Under Article 15.4, G/TBT/19,  14 November 2006, para. 8. 
4 Id. at para. 17. 
5 Id. at para. 19(d) and (e). G/TBT/W/315 
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  3. This submission provides additional background on the importance of regulatory coordination 
and cooperation in ensuring good regulatory practi ce and adherence to TBT obligations, and provides 
an overview of how the United States attempts to  accomplish these objectives through strong central 
government management of its regulatory regime, an  effective interagency trade policy mechanism, 
and robust public consultation.   
II. BACKGROUND 
4. Regulatory coordination and consistency are indispensable for ensuring good regulatory 
practice and for preventing the creation of unneces sary obstacles to trade.  The TBT Committee has 
emphasized the importance of effective coordinatio n among trade officials, standards organizations, 
and regulators by Members in implementing the TBT Agreement.
6  
5. Meanwhile, APEC and OECD reviews and studi es of countries’ regulatory reform efforts 
have demonstrated that a well coordinated and "w ell organized and monitored [regulatory] process, 
driven by ‘engines of reform’ with clear accountab ility for results, is important for the success of a 
country’s regulatory quality policy".7  The APEC-OECD Integrated Checklist on Regulatory Reform 
integrates APEC and OECD principles on regula tory reform, including the importance of 
accountability and coordination within governments.8 
6. In addition, in its model procedures and gui dance notes for implementation of the WTO TBT 
Agreement, the International Trade Centre has stre ssed the importance of the establishment of strong 
coordinating bodies by central governments in order to facilitate implementa tion of good regulatory 
practice and implementation of their TBT obligati ons through review of regulations, regulatory 
impact analysis, and interagency cooperation.9   
III. IMPLEMENTATION OF GOOD REGULATO RY PRACTICE PRINCIPLES IN THE 
UNITED STATES: STRONG CENTRAL GOVERNMENT MANAGEMENT AND COORDINATION 
7. Effective coordination of regulatory progra mmes and activities often depends upon strong 
central government management of the regulatory regime.  For example, in the United States, 
centralized regulatory oversight in the Office of  Management and Budget (OMB) in the executive 
branch of the government is intended in part to minimize duplication and inconsistency among 
                                                     
 
6 Committee on Technical Barriers to Trade,  Workshop on Good Regulatory Practice, 
G/TBT/GEN/67/Rev.1, 17 March 2008, paras. 2 and 4; Second Triennial Review of the Operation and Implementation of the Agreement on Technical Barriers to Trade, G/TBT/9, 13 November 2000, para. 7; and 
David Shortall, “Regulatory Reform and Market Openne ss: Processes to Assess Effectively The Trade and 
Investment Impact of Regulation," OECD Trade Policy Working Paper No. 28, pp. 31-32. 
7 Pedro Andres Amo and Delia Rodrigo, Background Document: Oversight Bodies for Regulatory 
Reform , OECD, February 2007, pp. 1-9; APEC and OECD, Synthesis Report: The APEC – OECD Integrated 
Checklist for Regulatory Reform: Results of Self Assessments, 2006-2007, in Five Economies , First Economic 
Committee Meeting, Lima, Peru, 25-26 February 2008; OECD, Regulatory Performanc e: Ex Post Evaluation of 
Regulatory Policies, Paris: OECD, 22 September 2003, http://www.oecd.org/dataoecd/34/30/30401951.pdf ; 
OECD Background Document on Oversight Bodies for Regulatory Reform , Paris: OECD, 2007, 
http://www.oecd.org/dataoecd/4/41/36785272.pdf ; APEC-OECD Integrated Checklis t on Regulatory Reform: 
Self-Assessment by the Commonwealth of Australia , APEC Economic Committee Meeting, Cairns, Australia, 
June 28-29, 2007; and OECD,  Regulatory Impact Analysis in OECD countries, Challenges for Developing 
Countries , Paris, 2005.   
8 See http://www.oecd.org/dat aoecd/41/9/34989455.pdf . 
9 International Trade Centre (ITC), Manual of Model Procedures and Guidance Notes for the 
Implementation of the WTO Agreement on Technical Barriers to Trade , Bulletin No. 82, April 2007, para. 8.3 
(p. 12) and Annexes 4, 4A, and 4B (pp. 41-45).  G/TBT/W/315 
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  regulations and to balance the demands of potentia lly competing or conflicting regulatory agencies 
and programmes.10  
8. Coordination between regulatory programmes was an early objective of regulatory reform in 
the United States and continues to be an important motivating force, under both major political parties, for stronger central management.
11 The first major presidential initiative to improve regulatory 
management was developed in 1971 to improve interagency coordinati on of regulation.  Interagency 
consultation and coordinati on were further strengthened in 1978, and executive orders issued in 1981 
and 1993 further refined and consolidated regulator y oversight within OMB to minimize regulatory 
inconsistency, conflict, and duplication.12  
9. Presently, U.S. regulatory policy is governed by presidential Executive Order (E.O.) 1286613 
which sets out principles of regulation an d requires coordinated review of Federal14 agency 
rulemaking "to ensure that regulations are consistent  with applicable law, the President’s priorities, 
and….that decisions made by one agency do not conf lict with the policies or actions taken or planned 
by another agency."15  The Order also requires agencies, when feasible, to consult with State and local 
governments before issuing regulations that may im pact those governmental entities and to assess the 
impact of Federal regulations on State and local governments and, as appropriate, seek to harmonize 
Federal regulations with related Stat e and local governmental functions.16  Further, E.O. 12866 
provides that agencies, in determining whether and how to regulate, should assess all costs and 
benefits of available regulatory alternatives, includi ng the alternative of not regulating and to make 
the regulatory process more accessible and open to  the public.  E.O. 12866 thus reinforces the 
philosophy that agencies should select the regulatory a pproach that maximizes net benefits to society, 
unless otherwise constrained by law.  
10. Within OMB, the Office of Information and Re gulatory Affairs (OIRA) is the repository of 
expertise concerning regulatory issues, methodologi es, and procedures that affect more than one 
Federal agency and, as such, oversees regulatory decision-making in U.S. agencies.17  Pursuant to 
E.O. 12866, OIRA oversees the regulatory proc ess for the Executive Bran ch by coordinating 
interagency review of draft regula tions and regulatory impact analyses of agencies to ensure that they 
are consistent with the Order’s regulatory principl es and with the President’s policies and priorities 
and to ensure that regulations of one agency do not conflict with those of another.  As the office that 
reviews significant regulations of the Federal governme nt, OMB is in the best position to ensure that 
the regulatory process flows smoothly, just as it is with its other central review functions with respect to the fiscal budget, legislative prop osals, and programme management. 
                                                     
 
10 APEC and OECD, “Synthesis Report: The APEC – OECD Integrated Checklist for Regulatory 
Reform: Results of Self Assessments, 2006-2007, in Five Economies," First Economic Committee Meeting, Lima, Peru, February 25-26, 2008, para. 7; and “Regulatory Reform in the United States: Enhancing Market 
Openness Through Regulatory Reform ." Paris: OECD, 1999, p. 1. 
11 OECD, Regulatory Reform in the United States: Government Capacity to Ensure High Quality 
Regulation , 1999, pp. 14-20. 
12 Ibid; Presidential Executive Order (E.O.) 12291, February 17, 1981; and E.O. 12866, September 30, 
1993. 
13 E.O. 12866 ( http://www.whitehouse.gov/o mb/inforeg/eo12866.pdf ). 
14 As used in this paper, the term “Federal" refers to the central level of government in the United 
States.   
15 See E.O. 12866. 
16 Ibid.  The U.S. Enquiry Point notifies both Federa l and State-level proposed technical regulations 
and conformity assessment procedures, pursuant to Articles 2, 3, 5, and 7 of the TBT Agreement.  From 2007-2009, the United States notified approximately 120 proposed State-level meas ures to the WTO.   
17 Ibid. G/TBT/W/315 
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  11. To ensure adequate consideration of specifi c regulatory impacts—such as those on small 
businesses, competition, and market openness—OIRA ’s interagency review process involves 
extensive consultation with other U.S. agencies w ith expertise in these areas.  For example, if 
questions arise with respect to the WTO-consistenc y of proposed or final regulations, OIRA includes 
the United States Trade Representative (USTR) in the Federal interagency review process that 
precedes publication of the regulations in the U.S. Federal Register .
18  In such instances, OMB, 
USTR, and the issuing regulatory agency seek to ensure that proposed regulatory measures comply 
with U.S. obligations under the WTO and other tr ade agreements, and are not otherwise unnecessarily 
trade restrictive.  In this regard, the Trade Agre ements Act of 1979, as amende d, requires U.S. Federal 
agencies to ensure that their standards-related activities confor m to specific TBT Agreement 
obligations, for example, that technical regula tions do not create unnecessary obstacles to trade or 
treat imported products less favorab ly than like domestic products.  
12. In addition, OMB has long provided guidance on regulatory analysis and the assessment of 
costs and benefits.  The latest such guidance is OMB’s Circular A-4, Regulatory Analysis, which OMB released in September 2003.
19  OMB developed the guidelines in collaboration with the 
President’s Council of Economic Advisors, and revised the proposed guidelines based on public 
comments, peer review, and interagency review.  Circular A-4 states that "[c]oncerns that new U.S. rules could act as non-tariff barriers to imported goods should be evaluated carefully."  
13. The successful implementation of a regulatory reform programme depe nds upon strong and 
committed political leadership.  In the United States, the support of the President has been critical to 
its success.  Early in his Administration, President Obama expressed his support for centralized 
review of Federal regulations by OMB, affirmi ng it as both a legitimate and appropriate means of 
coordinating regulatory policy.
20  Because the President believes that  a great deal has been learned 
about how to improve the process of regulatory revi ew since the fundamental principles and structures 
governing regulatory review were set out in E.O. 12866, he has directed the Director of OMB to consult with representatives of regulatory agencies to produce a set of recommendations for a new 
Executive Order on Federal regulatory review.
21  
IV. INTERAGENCY TRADE POLICY COORDINATION 
14. The Office of the United States Trade Representative (USTR), meanwhile, oversees an 
interagency trade policy process that incorpor ates input from dozens of government agencies, 
including regulatory agencies, in the implementati on and coordination of U.S. trade policy.  Three 
tiers of committees develop U.S. Government pos itions on international trade and trade-related 
investment issues.22  The first tier is the Cabinet-level National Economic Council (NEC), which is 
chaired by the President. NEC representation includes the Vice President, the Secretaries of State, Treasury, Agriculture, Commerce, Labor, Housing and Urban Development, Transportation, and 
Energy, the Administrator of the Environmental Prot ection Agency (EPA), the Chair of the Council of 
Economic Advisers (CEA), the Director of OMB, th e USTR, the National Security Advisor, and the 
Assistants to the President for Economic Polic y, Domestic Policy, and Science and Technology 
                                                     
 
18 OECD, “Regulatory Reform in the United States: Government Capacity to Ensure High Quality 
Regulation," 1999, pp. 17-18. 
19 http://www.whitehouse.gov/omb /circulars/a004/a-4.pdf . 
20 74 Fed Reg 5977 (3 February 2009). 
21 President Obama emphasizes, among other things, that the recommendations should offer 
suggestions for the relationship between OIRA and Fe deral agencies; provide gu idance on disclosure and 
transparency; encourage public participation in agency regulatory processes; identify means for ensuring that 
regulatory review does not pr oduce unnecessary delay; clar ify the role of the behavior al sciences in formulating 
regulatory policy; and identify the best tools for achieving public goals through the regulatory process.  Ibid. 
22 USTR, 2009 Trade Policy Agenda and 2008 Annual Report of the President of the United States , 27 
March 2009, pp. 242-243.   G/TBT/W/315 
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  Policy.  All executive departments and agencies, whether or not represented on the NEC, coordinate 
economic policy through the NEC. 
15. The Trade Policy Review Group (TPRG) and the Trade Policy Staff Committee (TPSC), 
administered and chaired by USTR, are the sub-cab inet interagency trade policy coordination groups 
central to this process.  The TPRG is composed of high level political appointees (Under Secretaries 
and Assistant Secretaries) from twenty government agencies.  The TPSC is staffed by senior civil 
servants.  Supporting the TPSC are more than 60 su bcommittees responsible for specialized areas and 
several task forces charged with particular issues.   In particular, there is a TPSC subcommittee on 
technical barriers to trade that addresses trade issu es regarding technical regulations, standards, and 
conformity assessment procedures.   
16. The TPRG and the TPSC are comprised of the De partments of Commerce, Agriculture, State, 
Treasury (which houses the Alcohol and Tobacco Tax and Trade Bureau (TTB)), Labor (which houses the Occupational Health and Safety Administ ration (OSHA)), Justice, Defense, Interior, 
Transportation, Energy, Homeland Security, and Health and Human Services (which houses the Food 
and Drug Administration (FDA)), EPA, OMB, CEA,  the Council on Environmental Quality (CEQ), 
the Agency for International Development (A ID), NEC, and the National Security Council.
23  T h e  
U.S. International Trade Commission (ITC) is a non- voting member of the TPSC and an observer at 
TPRG meetings.  Representatives of other agenci es, such as the Consumer Product Safety 
Commission (CPSC), may be invited to attend meeti ngs depending on the specific issues discussed.  
The National Institute of Standards and Technology (NIST), which is part of the Department of 
Commerce and houses the U.S. WTO TBT Inquiry Point,  also frequently attends meetings to provide 
technical expertise on standards and conformity assessment issues, as well as updates on Inquiry Point 
activities.    
17. On TBT matters, the vast majority of decision-making takes place at the TPSC subcommittee 
on technical barriers to trade.  In cooperation an d coordination with relevant agencies, including 
regulatory agencies, USTR is responsible for m onitoring U.S. compliance with WTO and any other 
international obligations relating to technical regulations, standards, and conformity assessment 
procedures, and for discussing with foreign governme nts any TBT-related "specific trade concerns" 
on U.S. measures that they have raised.  This  ongoing interaction among agencies responsible for 
trade and regulatory matters builds understanding of, and advocacy for, tr ade-facilitative regulatory 
practices.  
18. During interagency review of U.S. trade and trade-related investment policies, advice is 
generally sought from private sector trade advisory committees24 and from Congress.25  The trade 
advisory committee system was established by Congr ess in the Trade Act of 1974, as amended.  Over 
800 advisors serve on these committees which USTR administers jointly with the Departments of Agriculture, Commerce, and Labor, and EPA.  Th e trade advisory committees help the U.S. 
Government identify trade barriers and provide a dvice on key objectives and negotiating positions for 
multilateral, bilateral, and regiona l trade negotiations, as well as other trade-related policy matters.  In 
particular, USTR and Commerce administer 16 I ndustry Trade Advisory Committees (ITACs), which 
comprise approximately 350 private-sector advisors who represent the U.S. industry sector.  USTR and Commerce officials meet at least quarterly with the ITAC on Standards and Technical Trade Barriers (ITAC 16), which is composed of cleared advisors from businesses, trade associations, 
                                                     
 
23 Ibid. 
24 Ibid., pp. 237-240. 
25 The congressional committees that have jurisdiction with respect to international trade are the House 
Committee on Ways and Means and the Senate Committee on Finance.  Other congressional committees that USTR may consult include the Hous e Committees on Agriculture and Ener gy and Commerce, and the Senate 
Committees on Agriculture, Commerce, an d Environment and Public Works.  G/TBT/W/315 
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  standards developers, and conformity assessment bodies.
26  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 labour and 
environment. 
V. PUBLIC CONSULTATION 
 
19. The Administrative Procedure Act (APA) provid es the foundation for regulatory transparency 
and accountability in the United States.  The APA requires that agencies  undertake a notice and 
comment process open to all members of the public , both foreign and domestic, for all rulemakings. 27  
In accordance with the Act, agencies publish pr oposed technical regulations and conformity 
assessment procedures in the Federal Register  and solicit public comment.  Officials at the U.S. WTO 
TBT Enquiry Point review the Federal Register  on a daily basis and notify proposed technical 
regulations and conformity assessment procedures to  the WTO.  Proposed rules currently open to 
public comment are also centrally located on one Federal website ( www.regulations.gov ).  The public 
can use this site to send their comments electroni cally to agencies on proposed rulemakings published 
for comment in the Federal Register .  Agencies consider the public comments, and publish the final 
rule in the Federal Register, including an announcement of when the rule will take effect, the basis 
and purpose of the rule, and a response to the public comments on the proposal.28   
20. To help the public identify planned rulemakings  of international interest, beginning in fall 
2008 the United States added an "international flag" to the Unified Agenda and Regulatory Plan.29  
These semi-annual (Agenda) and annual (Plan) publi cations provide uniform reporting of data on 
regulatory and deregulatory actions under develo pment throughout the Federal government.  The 
public can now search both documents for a list of  entries with international impacts, and can 
combine such a search with other data elements of  interest, such as rulemakings by a particular 
Federal agency, or whether or not the rule is econo mically significant or has small business impacts.  
VI. RECOMMENDATIONS 
21. This submission has outlined what the United Stat es believes are the three critical pillars for 
ensuring that agencies follow good regulatory practi ce and that their regulations adhere to TBT 
Agreement obligations - strong central government management of a Membe r’s regulatory regime, 
effective interagency trade policy coordination, and robus t public consultation - and describes how the 
United States has attempted to opera tionalize those concepts within its regulatory system.  We believe 
that our experience underscores the importance of institutionalizing each of these elements through 
laws, regulations, procedures, guida nce, and other mechanisms, as we ll as the creation or designation 
of institutions within Members’ governme nts to oversee the regulatory process.   
22. The United States recommends to the Committee that Members share views and experiences 
on the role of domestic regulatory and trade po licy coordination, as well as public consultation 
mechanisms, in implementing good regulatory pr actices and preventing the creation of unnecessary 
technical barriers to trade.   
                                                      
26 See http://www.ustr.gov/Who_We_Are/List_of_USTR_Advisory_Committees.html .   
27 The terms “rule" and “rulemaking" are “terms of art" in the United States and refer to a broader 
group of measures that also encompass technical re gulations and conformity assessment procedures.    
28 Most of the U.S. States also have an equiva lent to the Administrative Procedure Act and publish 
proposed technical regulations and conformity assessment procedures in their individual state gazettes.  The 
U.S. WTO TBT Inquiry Point monitors the StateNet electronic database, which compiles proposed technical 
regulations and conformity assessment procedures from th roughout the fifty U.S. States, and notifies them to the 
WTO.   
29 See http://www.reginfo.gov/public/do/eAgendaMain.   G/TBT/W/315 
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  23. In that context, we also recommend that Me mbers submit to the Committee descriptions of 
the processes, mechanisms, and institu tions they have in place to (1) ensure the technical regulations 
and conformity assessment procedures they adopt are consistent with international obligations; (2) 
address "specific trade concerns" raised by other Members bilaterally, in co mments submitted through 
the Enquiry Points, or in the Committee itself; and (3) ensure consistency between the positions they 
take with respect to other Members’ measures and their own measures.  Sharing experiences on these 
issues, including how existing systems help Memb ers take comments into account in finalizing 
particular measures, could assist other Members in  establishing their own processes and mechanisms, 
as well as in making adjustments to existing systems that may be performing suboptimally. 
24. The United States would also recommend that Members explore the establishment of 
mechanisms to coordinate trade and regulatory polic y at the central government level, or to consider 
possible improvements to existing mechanis ms and institutions, as the case may be.   
 
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