INTERNATIONAL 

REGULATORY 

COOPERATION

Agency Efforts Could 

Benefit from 

Increased 

Collaboration and 

Interagency Guidance

Report to the Chairman, Committee on 

Oversight and Government Reform, 

House of Representatives

August 2013

GAO-13-588

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-588, a report to the 

Chairman, Committee on Oversight and 

Government Reform, House of 

Representatives

August 2013

INTERNATIONAL REGULATORY COOPERATION

Agency Efforts Could Benefit from Increased 

Collaboration and Interagency Guidance 

Why GAO Did This Study

Trade has increased as a share of the 

economy for several years, but U.S. 

companies can face difficulties 

competing in foreign markets when 

countries apply different regulatory 

requirements to address similar health, 

safety, or other issues. GAO was 

asked to examine what U.S. agencies 

are doing to engage in international 

regulatory cooperation. This report (1) 

provides an overview of U.S. 

regulatory agencies’ international 

cooperation activities; (2) examines 

ways that U.S. agencies incorporate 

outcomes from international regulatory 

cooperation activities and consider 

competitiveness during rulemaking; 

and (3) examines factors identified by 

U.S. agencies and stakeholders that 

act as facilitators or barriers to 

international regulatory cooperation. 

GAO analyzed documents and 

interviewed officials from seven U.S. 

agencies that regulate products traded 

internationally and four U.S. agencies 

with government-wide roles and 

responsibilities. GAO also interviewed 

officials from 11 organizations 

representing business and consumer 

advocacy perspectives that reported or 

publicly commented on international 

regulatory cooperation. The scope of 

this study is not intended to be a 

complete catalog of agencies’ activities 

and is not generalizable to all entities 

that have interests in this area. 

What GAO Recommends

GAO recommends the RWG include in 

forthcoming guidance on Executive 

Order 13609 tools to enhance 

collaboration, such as mechanisms to 

facilitate staff level dialogues. The 

Office of Management and Budget 

(OMB) did not have comments on the 

recommendation. 

What GAO Found

All seven U.S. regulatory agencies that GAO contacted reported engaging in a 

range of international regulatory cooperation activities to fulfill their missions. 

These activities include the United States and its trading partners developing and 

using international standards, recognizing each other’s regulations as equivalent, 

and sharing scientific data. U.S. agency officials GAO interviewed said they 

cooperate with foreign counterparts because many products they regulate 

originate overseas and because they may gain efficiencies—for example, by 

sharing resources or avoiding duplicative work. Cooperation can address both 

existing and avoid future regulatory differences. Officials also explained how 

cooperative efforts enhance public health and safety, facilitate trade, and support 

competitiveness of U.S. businesses. Several U.S. interagency processes require 

or enable interagency collaboration on international cooperation activities. The 

Regulatory Working Group (RWG), chaired by OMB and the Trade Policy Staff 

Committee (TPSC) are forums that have different responsibilities related to the 

regulatory and trade aspects of international regulatory cooperation. U.S. 

regulatory agency officials said the current processes could benefit from better 

information sharing among agencies on the implementation of international

cooperation activities and lessons learned. Without enhancements to current 

forums, opportunities to share practices and improve outcomes could be missed. 

Executive Order 13609, issued in May 2012, tasked the RWG with enhancing 

coordination and issuing guidance on international regulatory cooperation, which 

the RWG is developing. Nonfederal stakeholders GAO interviewed reported 

challenges to providing input on U.S. agencies’ international regulatory 

cooperation activities, in particular that they are not always aware of many of 

these activities and participation can be resource intensive. 

Officials GAO interviewed said the outcomes from international regulatory 

cooperation inform all phases of the rulemaking process, from helping an agency 

decide whether to regulate to implementing and enforcing regulations. U.S. 

agencies are not required to conduct a separate analysis on the competitiveness 

impacts on U.S. businesses when developing regulations. However, five of the 

seven U.S. agencies told GAO they do consider competitiveness. Officials we 

interviewed also pointed out that any analysis of impacts may not rise to the level 

of inclusion in the rulemaking record. In addition, U.S. agencies’ use of 

international standards in regulations can lower costs for U.S. businesses and 

reduce barriers to trade. Officials from all of the U.S. agencies GAO interviewed 

said they consider international standards during rulemaking partly in response to 

requirements in trade agreements, U.S. statutes, and executive orders.

Officials from all of the U.S. agencies GAO interviewed identified seven key 

factors that affect the success of international regulatory cooperation activities: 

(1) dedicated resources, (2) established processes, (3) high-level leadership, (4) 

scientific and technical exchanges, (5) stakeholder involvement, (6) statutory 

authority, and (7) early and ongoing coordination. When present, these factors 

can facilitate U.S. agencies’ efforts, but they can also act as barriers when 

absent. GAO found that these factors also reflect the seven key features for 

implementing collaborative mechanisms previously identified in its September 

2012 report on interagency collaboration. 

View GAO-13-588. For more information, 

contact Michelle Sager at (202) 512-6806 or 

sagerm@gao.gov. 
Page i GAO-13-588 International Regulatory Cooperation

Letter 1 

Background 4

U.S. Agencies Engage in Six Primary Categories of International 

Regulatory Cooperation Activities 10

Agencies Consider International Regulatory Cooperation and 

Competitiveness during Rulemaking in Different Ways 19

Key Factors Can Positively or Negatively Affect the Outcomes of 

International Regulatory Cooperation Activities 25

Conclusions 33

Recommendation for Executive Action 34

Agency Comments and Our Evaluation 34

Appendix I Objectives, Scope and Methodology 36

Appendix II Examples of International Regulatory Cooperation Activities 39

Appendix III Comments from the Department of Energy 52

Appendix IV Comments from the Consumer Product Safety Commission 53

Appendix V GAO Contact and Staff Acknowledgment 55

Tables

Table 1: Government-wide Roles and Responsibilities Related to 

International Regulatory Cooperation 5

Table 2: Categories of International Regulatory Cooperation 

Activities by U.S. Agencies 10

Table 3: Key Factors Identified by Agencies that Affect 

International Regulatory Cooperation 25

Contents 
Page ii GAO-13-588 International Regulatory Cooperation

Abbreviations

(Q)SARs Quantitative Structure-Activity Relationships

4E Efficient Electrical End-Use Equipment

AMS Agricultural Marketing Service

APA Administrative Procedure Act

APEC Asia-Pacific Economic Cooperation

APHIS Animal and Plant Health Inspection Service

Commerce Department of Commerce

CPSC Consumer Product Safety Commission 

DOE Department of Energy

DOJ Department of Justice

DOT Department of Transportation

EMA European Medicines Agency

EPA Environmental Protection Agency

EU European Union

FAS Foreign Agricultural Service 

FDA Food and Drug Administration

FSIS Food Safety and Inspection Service

FSMA Food Safety Modernization Act

FTA Free Trade Agreement

FTC Federal Trade Commission

GDP Gross Domestic Product

HC Health Canada

HHS Department of Health and Human Services

ICN International Competition Network

IEA International Energy Agency

ISO International Organization for Standardization

ITA International Trade Administration

NAFTA North American Free Trade Agreement
Page iii GAO-13-588 International Regulatory Cooperation

NHTSA National Highway Traffic Safety Administration

NIST National Institute of Standards and Technology

NOP National Organic Program

OAR Office of Air and Radiation

OCSPP Office of Chemical Safety and Pollution Prevention

OECD Organisation for Economic Co-operation and

 Development

OIE World Organization for Animal Health

OIRA Office of Information and Regulatory Affairs

OMB Office of Management and Budget

PAI Pilot Alignment Initiative 

PHMSA Pipeline and Hazardous Materials Safety

 Administration

RCC U.S.-Canada Regulatory Cooperation Council

RWG Regulatory Working Group

SPS Sanitary and Phytosanitary

SPS Agreement WTO Agreement on the Application of Sanitary and

 Phytosanitary Measures

State Department of State

TBT Technical Barriers to Trade

TBT Agreement WTO Agreement on Technical Barriers to Trade

TDG Subcommittee Transport of Dangerous Goods Subcommittee

TPSC Trade Policy Staff Committee

UN United Nations

Unified Agenda Unified Agenda of Federal Regulatory and 

 Deregulatory Actions

USAID United States Agency for International

 Development

USDA United States Department of Agriculture

USTR Office of the United States Trade Representative

WHO World Health Organization

WP.29 World Forum for Harmonization of Vehicle

 Regulations

WTO World Trade Organization

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Page 1 GAO-13-588 International Regulatory Cooperation

441 G St. N.W.

Washington, DC 20548

August 1, 2013

The Honorable Darrell E. Issa

Chairman

Committee on Oversight and Government Reform

House of Representatives

Dear Mr. Chairman:

U.S. exports and imports grew from 22.8 percent of gross domestic 

product (GDP) in 2002 to 31.4 percent of GDP in 2012, or a total of $4.9 

trillion. Doubling U.S. exports by 2014 is a goal of the President’s National 

Export Initiative.1 Nonetheless, U.S. companies can find it difficult to 

compete in foreign markets when countries have different requirements 

for addressing similar health, safety, or other regulatory issues. 

International regulatory cooperation—agencies’ engagement with foreign 

counterparts on issues related to their regulatory missions, such as 

international standards development, scientific collaboration, and 

information sharing—can help lower costs for businesses, increase U.S. 

exports, and further economic growth and job creation.2 International 

regulatory cooperation can also have other benefits, including increasing 

the safety and quality of other countries’ exports to the United States, 

thus helping to protect U.S. consumers. Some of our recent reports have 

shown that U.S. regulatory agencies have been struggling to adequately 

protect the public in the face of rising imports and increasingly complex 

supply chains.3

 

1

Exec. Order No. 13534, National Export Initiative, 75 Fed. Reg. 12,433 (Mar. 16, 2010). 

For example, in September 2009, we reported that the 

Food and Drug Administration (FDA) needed to address gaps in 

2

Commerce officials pointed out that the term standard can have different meanings. For 

example, the term standard may be used to define a technical requirement or a technical 

standard, or refer to a regulatory requirement in the context of a model regulation, or refer 

to a commonly used general requirement. For simplicity, we use the term international 

standard throughout the remainder of this report.

3

See GAO, Consumer Product Safety Commission: Agency Faces Challenges in 

Responding to New Product Risks, GAO-13-150 (Washington, D.C.: Dec. 20, 2012); Food 

Safety: FDA Can Better Oversee Food Imports by Assessing and Leveraging Other 

Countries’ Oversight Resources, GAO-12-933 (Washington, D.C.: Sept. 28, 2012); and 

Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to 

Enhance Safety of Imported Food, GAO-09-873 (Washington, D.C.: Sept. 15, 2009).

 
 

Page 2 GAO-13-588 International Regulatory Cooperation

enforcement and collaboration domestically and abroad to enhance the 

oversight of food imports.4

In May 2012, the President issued Executive Order 13609 on promoting 

international regulatory cooperation to provide high-level support and 

direction for U.S. agencies’ international regulatory cooperation efforts.

The executive order directed agencies to consider addressing 

unnecessary differences in existing regulations and describes processes 

to help avoid regulatory divergence in the future. Recent reports show 

that nonfederal stakeholders have mixed views regarding international 

regulatory cooperation. Some industry stakeholders are generally 

supportive of international regulatory cooperation efforts, especially in the 

context of reducing unnecessary barriers to trade,5

In this context, you asked us to examine what federal agencies are doing 

to engage in international regulatory cooperation. This report (1) provides 

an overview of regulatory agencies’ international cooperation activities; 

(2) examines ways that agencies incorporate outcomes from international 

regulatory cooperation activities and consider competitiveness during 

rulemaking; and (3) examines factors identified by agencies and 

nonfederal stakeholders that act as facilitators or barriers to international 

regulatory cooperation and to considering competitiveness. For the 

purposes of this report, competitiveness refers to the ability of U.S. firms 

to sell into international markets.

while some consumer 

advocacy stakeholders expressed concerns that efforts to align U.S.

regulations with trading partners could lower the protection of safety and 

health in U.S. regulations.

To identify the U.S. regulatory agencies with a significant number of 

regulations related to international trade, we analyzed the 2010 and 2011 

Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified 

 

4

GAO-09-873. In this report, we made 12 recommendations to improve the coordination, 

collaboration, information sharing, and screening systems supporting U.S. food safety 

programs, 9 of which have been implemented.

5

The World Trade Organization (WTO) Agreement on Technical Barriers to Trade 

obligates WTO members to ensure that technical regulations are not prepared, adopted, 

or applied with a view to or with the effect of creating unnecessary obstacles to 

international trade. See Agreement on Technical Barriers to Trade, Apr. 15, 1994, 

Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal 

Instrument - Results of the Uruguay Round, 1868 U.N.T.S. 120 (1994) [hereinafter 

referred to as the TBT Agreement].
 

Page 3 GAO-13-588 International Regulatory Cooperation

Agenda),6 as well as data from the 2011 World Trade Organization 

(WTO) Technical Barriers to Trade (TBT) Information Management 

System. We applied criteria to select agencies that regulate products that 

are traded internationally and assure the inclusion of some independent

regulatory agencies in our review. We analyzed documents and 

interviewed officials from seven U.S. regulatory agencies out of 60 U.S. 

agencies that are included in the Unified Agenda, including the 

Department of Energy (DOE), the Department of Health and Human 

Services’ (HHS) FDA, the Department of Transportation (DOT), the 

Environmental Protection Agency (EPA), the United States Department of 

Agriculture (USDA), the Consumer Product Safety Commission (CPSC), 

and the Federal Trade Commission (FTC). We selected these agencies 

because they regulate products that are traded internationally, such as 

medical devices, chemicals, toys, automobiles, and food. These views 

are not generalizable to all U.S. agencies. We reviewed documents and 

interviewed officials from the four agencies with government-wide 

regulatory and international coordination roles and responsibilities: the 

Office of Management and Budget (OMB), the Office of the United States 

Trade Representative (USTR), the Department of Commerce 

(Commerce), and the Department of State (State).7

 

6

The Unified Agenda provides uniform reporting of data on regulatory and deregulatory 

activities under development throughout the U.S. federal government. All entries in the 

online Unified Agenda contain uniform data elements, including “international impacts” 

(whether the regulation is expected to have international trade and investment effects, or 

otherwise may be of interest to the nation’s international trading partners).

To obtain a broader 

set of perspectives, including those of participants from outside 

government agencies, we interviewed officials from 11 academic and 

stakeholder organizations representing business and consumer advocacy 

perspectives, such as the U.S. Chamber of Commerce and Public 

Citizen. We selected these organizations based on published views on 

international regulatory cooperation and recommendations from agencies 

in our study. These views are not generalizable, but provided insights. 

Using criteria based on our September 2012 report on interagency 

collaborative efforts, we also compared agencies’ documents and 

testimonial evidence about their international regulatory cooperation 

7

USDA, which is a regulatory agency, also has a coordinating role as the national enquiry 

point for the World Trade Organization’s Agreement on the Application of Sanitary and 

Phytosanitary Measures. 
 

Page 4 GAO-13-588 International Regulatory Cooperation

activities to the seven key features that we found agencies should 

consider when implementing collaborative mechanisms.8

We tested the reliability of the databases used to help select agencies to 

include in this review by reviewing related documentation, interviewing 

knowledgeable agency officials, and tracing a sample of entries to source 

documents. We concluded that the data were sufficiently reliable for the 

purposes of this report. Throughout this report, we use specific, selected 

examples to illustrate general agency processes and practices. The 

scope of our inquiry is neither a complete catalog of international 

regulatory activities nor generalizable to all individuals who have interests 

in international regulatory cooperation and global competitiveness. 

Appendix I provides a more detailed description of our objectives, scope, 

and methodology.

We conducted this performance audit from March 2012 to August 2013, 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives. 

U.S. agencies have different responsibilities related to international 

regulatory cooperation. For example, Commerce, State, USTR, OMB, 

and USDA have government-wide responsibilities. Their roles and 

responsibilities are determined primarily through statutes and executive 

orders. U.S. treaty obligations also influence their activities, as shown in 

table 1. To some extent these agencies bring structure and direction to 

activities that are in practice pursued in a decentralized manner by 

multiple agency participants.

 

8

GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012). To identify 

the key features, we conducted a literature review of academic work, interviewed a 

number of experts in governmental collaboration, and analyzed a sample of our prior 

work.

Background 

U.S. Agency Roles and 

Responsibilities 
 

Page 5 GAO-13-588 International Regulatory Cooperation

Table 1: Government-wide Roles and Responsibilities Related to International Regulatory Cooperation

Agency Roles and Responsibilities

Department of Commerce (Commerce) The role of Commerce’s International Trade Administration (ITA) in international regulatory 

cooperation is generally to coordinate with industry to obtain its input on U.S. producers’ 

concerns about global competitiveness and market access. ITA also has a role in some 

international regulatory cooperation initiatives, such as regulatory cooperation councils 

and has responsibility for monitoring compliance with nonagricultural international trade 

agreements to which the United States is a party. Commerce’s National Institute of 

Standards and Technology (NIST) is responsible for notifying the World Trade 

Organization (WTO) of proposed regulations that could have trade impacts and serving as 

the U.S. national enquiry point for the WTO Agreement on Technical Barriers to Trade 

(TBT Agreement). Per the National Technology Transfer and Advancement Act, NIST is 

also responsible for coordinating federal, state, and local technical standards and 

conformity assessment activities with the same activities of the private sector. The goal is 

to eliminate unnecessary duplication and complexity in the development and promulgation 

of conformity assessment requirements and measures. 

Department of State (State) The Secretary of State is responsible, on behalf of the President, for ensuring that all 

proposed international agreements of the United States are fully consistent with U.S. 

foreign policy objectives. According to State, no agency of the U.S. government may 

conclude an international agreement, whether entered into in the name of the U.S. 

government or in the name of the agency, without prior consultation with the Secretary or 

his designee.

United States Trade Representative 

(USTR)

USTR leads U.S. trade policy and coordinates the efforts of U.S. agencies to reduce 

barriers to trade such as discriminatory foreign regulations. It also represents the United 

States in international trade forums such as the WTO, oversees U.S. implementation of 

trade agreements, and monitors compliance with trade commitments. To prevent 

regulation-related trade barriers, it has promoted adoption of good regulatory practice 

guides by international economic forums.

Office of Management and Budget (OMB) OMB coordinates interagency review of significant rulemakings. OMB also plays a 

leadership role in government-wide international regulatory cooperation initiatives, such as 

regulatory cooperation councils. Under Executive Order 13609, the Regulatory Working 

Group (RWG), chaired by OMB’s Office of Information and Regulatory Affairs (OIRA), 

provides a forum for international regulatory cooperation. 

Department of Agriculture (USDA) USDA is the national enquiry point for the WTO Agreement on the Application of Sanitary 

and Phytosanitary Measures (SPS Agreement), coordinates U.S. government comments 

on foreign SPS regulations, and notifies the WTO of U.S. regulations that may have trade 

impacts. USDA houses the U.S. government offices for coordination with Codex 

Alimentarius Commission, World Organization for Animal Health, and International Plant 

Protection Convention, the three international standard setting bodies referenced by the 

SPS Agreement. 

Source: GAO analysis of agency documents.

U.S. regulatory agencies have varying missions, such as protecting public 

health or safety, and engage in multiple activities to fulfill their missions. 

Statutes establish agencies’ missions and establish the scope and limits 

of each agency’s authority. Agencies often implement their statutory 

missions by developing, issuing, and enforcing regulations. Agencies may 

also need to comply with multiple procedural and analytical requirements 

during the rulemaking process that precedes the issuance of regulations, 
 

Page 6 GAO-13-588 International Regulatory Cooperation

including participation in interagency review and coordination processes 

summarized in table 1.

Regulation is one of the principal tools that the U.S. federal government 

uses to implement public policy. Underlying federal regulatory actions is 

the long-standing rulemaking process established by the Administrative 

Procedure Act (APA).9 This act establishes broadly applicable federal 

requirements for informal rulemaking, also known as notice and comment 

rulemaking.10

1. Consideration of regulatory action: The agency gathers information to 

determine (1) whether a rulemaking is needed and (2) the range of 

regulatory options.

At a high level, domestic rulemaking activities governed by 

the APA generally include four basic phases:

11

2. Development and issuance of proposed regulation: The agency drafts 

a proposed regulation, including the preamble (the portion of the 

regulation that informs the public of the supporting reasons and 

purpose of the regulation) and the language in the regulation. The 

agency also begins to address analytical and procedural requirements 

and engages in interagency coordination and OMB review, where 

required. After these are complete, the agency publishes the 

proposed regulation in the Federal Register and requests comments 

from the public.

3. Development and issuance of final regulation: The agency responds 

to public comments, completes analytical and procedural 

requirements, engages in interagency coordination and OMB review 

where required, and publishes the final regulation in the Federal 

Register. 

4. Implementation of final regulation: The agency enforces compliance 

with the final regulation and monitors its performance.

 

9

Pub. L. No. 79-404, 60 Stat. 237 (1946), codified in 1966 in scattered sections of title 5, 

United States Code. Some agencies, such as CPSC, have statutory rulemaking 

requirements that add processes and steps beyond those required by the Administrative 

Procedure Act. See, e.g., 13 U.S.C. § 2058. 

10The APA describes two types of rulemaking, formal and informal. Formal rulemaking 

includes a trial type “on-the-record” proceeding. Most federal agencies use the informal 

rulemaking procedures outlined in 5 U.S.C. § 553. 

11A retrospective review of an existing rule may prompt this consideration.

Regulatory Context 
 

Page 7 GAO-13-588 International Regulatory Cooperation

Various executive orders and guidance establish agencies’ processes 

that govern international regulatory cooperation activities. Executive 

Order 12866 established the basic principles and processes that help 

guide and coordinate regulatory actions by executive agencies (other 

than independent regulatory agencies).12 Three components of the order 

are especially relevant to current regulatory cooperation efforts. First, the 

order established general principles for government regulation, including 

that agencies should assess the costs and benefits of available regulatory 

alternatives. Second, the order established centralized review and 

coordination of rulemaking, particularly by (1) requiring agencies to 

submit draft significant regulations to OMB’s Office of Information and 

Regulatory Affairs (OIRA) for interagency review before they are 

published13 and (2) establishing the RWG to serve as a forum to assist 

agencies in identifying and analyzing important regulatory issues14 Third, 

the order required agencies to compile and make public their regulatory 

agendas and plans, which include identifying the anticipated effects of 

forthcoming regulations. Executive Order 13563 reaffirmed the principles, 

structures, and definitions governing contemporary regulatory review that 

were established by Executive Order 12866.15

OMB periodically issues guidance to executive agencies on implementing 

executive orders. One key example related to the regulatory review 

orders discussed above is OMB Circular A-4, issued in 2003. The circular

provides OMB’s guidance on the development of regulatory analysis as 

Particularly relevant to this 

report, the order states that the regulatory system must promote 

competitiveness, and it also expanded expectations for agencies to 

retrospectively review their existing regulations.

 

12Exec. Order No. 12866, Regulatory Planning and Review, 58 Fed. Reg. 51,735 (Oct. 4, 

1993).

13Executive Order 12866 defines significant regulatory actions to include those that are 

likely to result in a rule that may have an annual effect on the economy of $100 million or 

more or adversely affect in a material way the economy, or create a serious inconsistency 

or otherwise interfere with an action taken, or planned by another agency.

14This working group is chaired by the OIRA Administrator, and it consists of 

representatives of leadership in each agency that the OIRA Administrator has determined 

has significant domestic regulatory responsibility. Per Executive Order 13609, the RWG 

includes a representative from USTR and, as appropriate, representatives from other 

agencies and offices.

15Exec. Order No. 13563, Improving Regulation and Regulatory Review, 76 Fed. Reg. 

3821 (Jan. 21, 2011).
 

Page 8 GAO-13-588 International Regulatory Cooperation

required under Executive Order 12866 and related authorities, defining 

good regulatory analysis and standardizing the way benefits and costs of 

federal regulatory actions are measured and reported. The circular 

includes a brief paragraph about considering the impacts of federal 

regulation on global markets and trade. In May 2011, USTR and OMB 

released a joint memorandum restating U.S. trade obligations and 

provided additional guidance to agencies on how to carry them out. In 

particular, the joint memorandum stressed the importance of agencies’ 

attention to regulatory analysis requirements in prior executive orders and 

OMB Circular A-4, as well as avoiding unnecessary barriers to trade as 

specified in the Trade Agreements Act. The memo also encouraged 

agencies to engage in international collaboration activities.

Some U.S. international regulatory cooperation efforts occur within the 

context of trade policy and negotiations. Reducing foreign regulatory 

barriers to trade is a key U.S. trade objective. In support of this objective, 

international agreements and U.S. legislation enacting them encourage 

and guide agencies’ participation in some international regulatory 

cooperation activities. For example, the Uruguay Round Agreements Act 

codifies the WTO Agreement on Technical Barriers to Trade (TBT 

Agreement) and the WTO Agreement on the Application of Sanitary and 

Phytosanitary Measures (SPS Agreement) and includes additional 

international regulatory cooperation responsibilities.16 Several of the most 

salient obligations are briefly described below.17

• TBT Agreement:18

 

1619 U.S.C. § 3511.

For technical regulations, the TBT Agreement 

requires members to use international standards or the relevant parts 

of them as a basis for technical regulations where available and 

appropriate, and, in certain instances, notify the WTO of proposed 

regulations with possible trade impacts and consider comments 

received before finalizing those regulations. Further, the TBT 

Agreement states that regulations should be no more trade restrictive 

than needed to fulfill a legitimate objective.

17Fuller explanations of these agreements may be found at: 

http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm4_e.htm

18 Specifically, TBT Agreement art. 2.2, 2.4, and 2.9. 

Trade Context
 

Page 9 GAO-13-588 International Regulatory Cooperation

• SPS Agreement:19

• Free Trade Agreements (FTA): According to USTR, FTAs, such as 

the U.S. Korea Free Trade Agreement, build on the disciplines of the 

TBT Agreement, by providing for greater transparency. Some U.S. 

FTAs also provide that interested parties and persons should be given 

opportunities to comment on proposed measures. According to 

Commerce officials, most of these bilateral trade agreements also 

provide for more timely notification mechanisms than multilateral 

mechanisms such as the TBT Agreement. Most of these bilateral 

trade agreements also provide for more timely notification 

mechanisms than multilateral mechanisms.

For SPS measures (including measures to protect 

animal or plant life from pests, diseases, or disease-causing 

organisms as well as to protect human or animal life), the SPS 

Agreement requires members to base their measures on existing 

international standards, or where the measure results in a higher level 

of protection, allows members to maintain or introduce their own 

standard if there is a scientific justification. Members are also required 

to ensure that their regulations are applied only to the extent 

necessary to protect human, animal, or plant life or health. Members 

are to notify the WTO at an early stage in the rulemaking if a 

proposed regulation differs from an international standard and may 

have a significant trade impact on other members, in order to receive 

comments for consideration.

In addition to these finalized agreements, the United States has offered 

proposals in ongoing Trans-Pacific Partnership negotiations toward a 

trade agreement among 11 participating nations to promote transparency. 

More recently, on February 13, 2013, President Obama and European 

Union (EU) leaders announced their intention to launch negotiations on a 

Transatlantic Trade and Investment Partnership. According to USTR, the 

goals of the partnership include reducing the cost of differences in 

regulation and standards by promoting greater compatibility, 

transparency, and cooperation.

 

19See Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 

1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal 

Instrument - Results of the Uruguay Round, 1867 U.N.T.S. 493, 33 I.L.M. 1125 (1994) 

[hereinafter referred to as the SPS Agreement]. Specifically, SPS Agreement art. 2, 3, 5, 

7, and Annexes A and B.
 

Page 10 GAO-13-588 International Regulatory Cooperation

All agencies in our study reported that they engage in a range of 

international regulatory cooperation activities. These activities include 

U.S. agencies and foreign counterparts sharing scientific data, developing 

and using the same international regulatory standards, and recognizing 

each other’s regulations as equivalent. Cooperation can address both 

existing and avoid future regulatory differences. These activities generally 

fall into six broad categories, as shown in table 2 below. See appendix II 

for details on the illustrative examples.

Table 2: Categories of International Regulatory Cooperation Activities by U.S. Agencies 

Activity Description Illustrative examples

Information sharing and 

scientific collaboration

Agencies share information with their 

foreign counterparts on scientific data and 

regulatory approaches.

• Pesticide Tolerance Crop Grouping Revisions 

Program 

• Chemical Data Information Sharing

• Consumer Product Safety Pilot Alignment Initiative 

Development and use of 

international standards

Agencies participate in international 

standards setting bodies and incorporate 

international standards into rulemaking as 

appropriate.

• World Forum for the Harmonization of Vehicle 

Regulations

• UN Subcommittee on the Transport of Dangerous 

Goods

• International Competition Network 

Equivalency agreements The United States enters into an 

agreement with another country to 

recognize their regulations and deem them 

equivalent to those of the United States.

• National Organic Program Equivalency Agreements

• Equivalency Determinations for the Import of Meat, 

Poultry, and Egg Products 

Strengthening capacity of 

developing countries

Most agencies in our study provide 

technical assistance to developing 

countries. Agency officials said they work 

with countries to strengthen their regulatory 

systems, among other reasons, to improve 

the safety of products imported into the 

U.S. 

• Food and Drug Administration

• Federal Trade Commission

• Animal and Plant Health Inspection Service 

Work sharing with foreign 

counterparts 

Agencies work with foreign counterparts on 

projects to share resources to implement 

regulations and avoid duplicating effort. 

• Food and Drug Administration Coordination on 

Inspections

• Animal and Plant Health Inspection Service Joint 

Animal Health Site Visits to Third Countries

Coordination on voluntary 

programs

Agencies cooperate with foreign 

counterparts on voluntary programs.

• Efficient End-use Electrical Equipment Implementing 

Agreement, Solid State Lighting Annex

Source: GAO analysis of agency documents and interviews.

International regulatory cooperation activities involve bilateral and 

multilateral governmental relationships and participation in third-party 

organizations, such as standards-setting bodies. For example, some 

agencies in our study participate in international organizations, such as 

U.S. Agencies Engage 

in Six Primary 

Categories of 

International 

Regulatory 

Cooperation Activities
 

Page 11 GAO-13-588 International Regulatory Cooperation

the World Organization for Animal Health (OIE)20 or the International 

Organization for Standardization (ISO).21 International cooperation 

activities may be formal or informal, ranging from participation in 

international organizations established by international agreements to 

informal regulatory information sharing and dialogues. International 

regulatory cooperation activities may also occur on a government-wide 

basis and address multiple sectors. For example, the U.S.-Canada 

Regulatory Cooperation Council (RCC) is an effort to increase regulatory 

transparency and coordination between the two countries. Action plans 

exist in the areas of agriculture and food, transportation, health and 

personal care products and workplace chemicals, the environment, and 

cross-sectoral issues. Similarly, OMB, Commerce, and other federal 

agencies also participated in the Asia-Pacific Economic Cooperation 

(APEC) effort to share and promote good regulatory practices, such as 

transparency and centralized review of regulations, among APEC 

economies.

Agency officials said they engage in international regulatory cooperation 

activities primarily because they are operating in an increasingly global 

environment and many products that agencies regulate originate 

overseas. For example, according to FDA’s Global Engagement Report, 

the United States imports 80 percent of active pharmaceutical ingredients 

and imports of FDA-regulated products have grown dramatically in recent 

years. FDA reported that the agency engages in international cooperation 

activities to ensure products produced overseas are safe for U.S. 

consumers. Similarly, CPSC operates in an increasingly global 

environment. According to CPSC, the value of U.S. imports under 

 

20The World Organization for Animal Health (formerly the Office International des 

Epizooties) is recognized by the SPS Agreement. Founded in 1924, the OIE has six main 

missions: (1) to ensure transparency in the global animal disease situation, (2) to collect, 

analyze and disseminate veterinary scientific information, (3) to provide expertise and 

encourage international solidarity in the control of animal diseases, (4) within its mandate 

under the WTO SPS Agreement, to safeguard world trade by publishing health standards 

for international trade in animals and animal products, (5) to improve the legal framework 

and resources of national veterinary services, and (6) to provide a better guarantee of 

food of animal origin and to promote animal welfare through a science-based approach. 

21The International Organization for Standardization (ISO) is an independent, nongovernmental organization made up of members from the national standards bodies of 

163 countries and 3,368 technical bodies. International standards give specifications for 

products, services and good practice, in areas such as food safety, computers, 

agriculture, and health care.

Agencies Cooperate 

Internationally to Fulfill 

Regulatory Missions
 

Page 12 GAO-13-588 International Regulatory Cooperation

CPSC’s jurisdiction has skyrocketed in recent years, with imports from 

China more than quadrupling from $62.4 billion in 1997 to $301.0 billion in 

2010. Moreover, in fiscal year 2012, 4 out of every 5 consumer product 

recalls or 345 of 439 recalls involved imported products, making imports a 

critical focus for CPSC.

Agencies also cooperate with foreign counterparts in an effort to gain 

efficiencies. For example, EPA participates in an initiative on pesticides 

through the Organisation for Economic Co-operation and Development 

(OECD) that has resulted in regulatory efficiencies. OECD also reported 

that, by accepting the same test results OECD-wide, unnecessary 

duplication of testing is avoided, thereby saving resources for industry 

and society as a whole.22 A 2007 study for the OECD Working Group on 

Pesticides estimated resource savings of 33 to 40 percent as a result of 

joint review by three to five countries, compared with each country 

working alone. The study noted that the savings from reducing duplicative 

expert evaluation work significantly outweighed the marginal increase for 

project management, coordination, and travel.23 These tools and 

approaches facilitate work sharing for regulators and help avoid costly, 

duplicative testing by ensuring that the data developed and submitted in 

one country can be used by other countries in reaching their regulatory 

decisions.24

Agencies’ efforts to cooperate on regulatory programs through 

cooperative activities may also have the effect of facilitating trade and 

supporting the competitiveness of U.S. businesses. FDA officials said that 

international regulatory cooperation and harmonization has public health 

benefits, promotes regulatory efficiency, and both also have indirect 

 

22OECD, International Regulatory Co-operation: Case Studies, Vol. 1: Chemicals, 

Consumer Products, Tax and Competition (OECD Publishing: 2013), accessed 5/14/2013 

http://dx.doi.org/10.1787/9789264200487-en. 

23For more information on EPA’s international efforts related to pesticides and food safety, 

see EPA, The Value of Countries Working Together to Regulate Pesticides and Food 

Safety: Achieving Public Health and Environmental Protection through International 

Collaboration, EPA 735-K0-9001 (Washington, D.C.: April 2009).

24Our prior work also found that coordination among domestic and foreign financial 

regulators improved the quality of rulemakings. For example, these coordination efforts 

likely eliminated duplication and helped fill regulatory gaps to limit risks migrating to 

unregulated markets. See GAO, Financial Regulatory Reform: Regulators Have Faced 

Challenges Finalizing Key Reforms and Unaddressed Areas Pose Potential Risks, 

GAO-13-195 (Washington, D.C.: Jan. 23, 2013). 
 

Page 13 GAO-13-588 International Regulatory Cooperation

competitiveness advantages for companies. FDA officials said that public 

health regulatory and competitiveness goals are often complementary: by 

upholding and enforcing scientifically valid standards, public health is 

protected and promoted at the same time that companies benefit from a 

level playing field that should make their products more competitive. 

Moreover, bringing a quality, safe, effective new drug to market faster 

yields health benefits for individuals because they have access to the 

drug sooner as well as trade benefits for industry, which has access to 

more markets.

In addition, U.S. agency officials said that when they participate in 

international standards development, an existing U.S. regulation or policy 

approach may be used as the basis for the international standard. When 

other countries adopt U.S. approaches to regulations, it can lower 

compliance costs and support competitiveness for U.S. businesses. For 

example, EPA’s Office of Air and Radiation (OAR) officials said that OAR 

worked within the World Forum for Harmonization of Vehicle Regulations 

(WP.29) to urge the use of a U.S. regulation as the basis for a global 

regulation on test procedures for off-highway construction vehicle 

engines. OAR officials said U.S. manufacturers supported this effort 

because U.S. manufacturers sell equipment internationally, and 

complying with one set of regulations reduces their fixed costs.

There are four interagency review processes routinely used to identify 

and review regulations that could have trade or competitiveness impacts 

and to encourage international regulatory cooperation.

• OMB officials said that a process for interagency coordination with 

OMB, USTR, State, and Commerce on regulations is the centralized 

regulatory review process under Executive Orders 12866 and 13563. 

USTR officials said they work with agencies as needed on regulatory 

issues that have an international impact prior to the interagency 

regulatory review process. However, the interagency review process 

ensures OMB, USTR, State, and Commerce another opportunity to 

provide input on any proposed significant regulation from agencies 

whether or not international impacts were raised earlier. Independent 

agencies are not required to participate in the interagency review 

process.

• The May 2012 Executive Order 13609 on promoting international 

regulatory cooperation establishes processes for agencies to report 

on efforts in this area. The order requires agencies that are required 

to submit a regulatory plan to report a summary of their international 

2012 Executive Order 

Outlines New Processes 

for International 

Cooperation, but Agencies 

Could Benefit from 

Additional Collaboration
 

Page 14 GAO-13-588 International Regulatory Cooperation

regulatory cooperation activities that are reasonably anticipated to 

lead to significant regulations in their regulatory plans. It also requires 

agencies to identify regulations with significant international impacts in 

the Unified Agenda, on Reginfo.gov,25 and on Regulations.gov.26

• Generally, all U.S. federal agencies are required to consult with State 

before concluding international agreements.27

• The Trade Agreements Act, as amended, requires U.S. agencies to 

coordinate in specified circumstances,

Among other things, 

State is responsible for ensuring that any proposed international 

agreement is consistent with U.S. foreign policy. State officials said 

that the Secretary of State must be consulted on international 

regulatory cooperation issues involving the negotiation or signing of 

international agreements or arrangements.

28

Current interagency review processes are designed to trigger reviews in 

certain instances, such as when agencies’ international regulatory 

cooperation activities include significant regulations, international 

agreements, and trade mechanisms. Many of the international regulatory 

cooperation activities reported in our study would not trigger these 

including with USTR on 

standards-related trade measures as part of their overall statutory 

responsibilities.

 

25The General Services Administration’s Regulatory Information Service Center and 

OMB’s OIRA established Reginfo.gov to assist users who want to find federal regulatory 

information such as regulatory agendas and regulatory plans including brief synopses and 

timetables for action on rules that federal departments and agencies are considering. See 

http://www.reginfo.gov/public/. 

26The federal government launched Regulations.gov in 2003 to enable citizens to search, 

view, and comment on regulations issued. See http://www.regulations.gov/#!home. 

2722 C.F.R. § 181.4(a). 

28For example, USTR is required to coordinate international trade policy issues that arise 

as a result of implementation of the WTO TBT agreement. USTR is also required to inform 

and consult any federal agencies having expertise in the matters under discussion or

negotiation in coordinating U.S. discussions and negotiations with foreign countries for the 

purpose of establishing mutual arrangements with respect to standards-related activities.

USTR also must consult with the cited agency and members of the interagency trade 

organization if a foreign government makes a representation to the USTR alleging that a 

U.S. standards-related activity violates U.S. TBT obligations. Commerce and USDA must 

coordinate with USTR with respect to TBT international standards-related activities that 

may substantially affect the commerce of the United States. Furthermore, with regard to 

TBT obligations, the Secretaries of Commerce and USDA have a role in assuring 

adequate representation of U.S. interests in international standards organizations, and 

encouraging cooperation among federal agencies so as to facilitate development of a 

unified U.S. position.
 

Page 15 GAO-13-588 International Regulatory Cooperation

processes, such as activities related to information sharing and scientific 

collaboration, capacity building, or the use of international standards in 

regulations that are not significant.

OMB and USTR also lead interagency forums on regulations and trade 

that have different responsibilities related to international regulatory 

cooperation. Executive Order 13609 assigns responsibilities to the 

Regulatory Working Group (RWG), chaired by OMB’s Administrator of 

OIRA, to serve as a forum to discuss, coordinate, and develop a common 

understanding among agencies of U.S. government priorities for 

international regulatory cooperation. According to OMB officials, the RWG 

provides a forum to foster greater cooperation and coordination of U.S. 

government strategies, including those for promoting regulatory 

transparency, sound regulatory practices, and U.S. regulatory 

approaches abroad. OMB officials also said that the RWG is developing

guidance to implement the executive order. USTR chairs the policy-level 

Trade Policy Staff Committee (TPSC), which maintains U.S. interagency 

mechanisms for trade policy coordination among State, Commerce, the 

Department of Labor, USDA, and other appropriate agencies. The TPSC 

identifies and addresses foreign government trade measures among 

other duties. USTR officials said USTR coordinates with agencies on 

trade issues related to regulations at the working level through the TPSC 

subcommittees on technical barriers to trade and sanitary and 

phytosanitary barriers to trade. USTR explained that these 

subcommittees are involved in supporting international regulatory 

cooperation by anticipating and resolving potential regulatory conflicts 

that could impair trade. USTR officials also noted that at the TPSC 

subcommittee level, USTR coordinates with officials from regulatory 

agencies in preparing for participation in international cooperation 

activities, such as APEC meetings, as well as regulators’ involvement in 

international standards development. Nevertheless, some agency 

officials reported that greater coordination between regulatory forums and 

trade forums could improve outcomes. USTR officials also said there is 

uncertainty about the implementation of Executive Order 13609 and how 

it will relate to USTR’s trade responsibilities. According to OMB officials, 

one of the main objectives of Executive Order 13609 is to improve 

coordination of international regulatory cooperation. They anticipate that 

forthcoming guidance on Executive Order 13609 will address 
 

Page 16 GAO-13-588 International Regulatory Cooperation

collaboration with the RWG and other interagency groups, particularly the 

TPSC.29

Beyond these forums for interagency coordination, regulatory agency 

officials we interviewed said the current processes could benefit from 

better information sharing among agencies on the implementation of 

international regulatory cooperation activities and lessons learned. We 

have previously found that it is important to ensure that the relevant 

participants have been included in the collaborative effort, including those 

with the knowledge, skills, and abilities to contribute to the outcomes of 

the collaborative effort.30

Regulatory agency officials we interviewed pointed out that additional 

ways to facilitate exchanges about best practices and day-to-day 

implementation would be helpful. An agency official said that there may 

be a benefit to having an interagency dialogue, working group, or other 

forum through which officials can share information on challenges and 

successes in implementing international regulatory cooperation. For 

example, officials said EPA and FTC both have regulations related to 

labeling and there may be opportunities that could result from sharing 

information and best practices with international regulators. Agency 

officials we interviewed identified another example illustrating the 

potential benefits of staff-level exchanges and information sharing during 

a multiagency meeting on this report. The officials that we interviewed 

said it is challenging to measure the outcomes of international regulatory 

cooperation activities and there is a need for an appropriate metric to 

show the value of funds spent on these activities. EPA officials we 

interviewed stated that in one case they successfully quantified the 

benefits from work with OECD’s Mutual Acceptance of Data program. 

According to EPA, the implementation of this decision has saved both 

governments of 34 member countries and industry nearly $225 million 

annually and also generated many nonquantifiable benefits, such as 

promoting animal welfare in chemical testing. Officials attending a GAO 

multiagency meeting said similar practices would be helpful to justify 

The RWG and TPSC are designed for highlevel, government-wide policy discussions, and participants in the RWG 

and TPSC are higher level management or policy officials who may be 

somewhat removed from the technical activities that underpin rulemaking.

 

29As of July 30, 2013 the guidance has not been issued.

30This is one of several key features outlined in GAO-12-1022. 
 

Page 17 GAO-13-588 International Regulatory Cooperation

investments in international regulatory cooperation activities. Agency 

officials we interviewed said they found a multiagency meeting on this 

report useful in part because the meeting involved discussions of day-today implementation of these issues. Further, Commerce officials 

suggested that enhanced coordination among participants in these 

forums would also benefit from including existing interagency standards 

policy groups, such as the Interagency Committee on Standards Policy 

and the National Science and Technology Council’s Subcommittee on

Standards. Without some enhancements to the current forums for 

regulators and trade officials to collaborate, opportunities to share 

practices and improve safety and regulatory efficiencies and to reduce 

trade barriers could be missed. Agency officials said there is currently not 

a forum to meet this need.

Although nonfederal stakeholder input into regulatory processes is 

important, the stakeholders we spoke with said it can be challenging for 

them to provide input into agencies’ international regulatory cooperation 

activities because of the required resources and the difficulty of becoming 

aware of such activities. Congresses and Presidents have required 

agencies to comply with multiple procedural requirements in an effort to 

promote public participation in rulemaking, among other goals.31

 

31For example, Executive Order 13563 states that regulations shall be adopted through a 

process that involves public participation and shall be based, to the extent feasible and 

consistent with law, on the open exchange of information and perspectives. The executive 

order also states that before issuing a notice of proposed rulemaking, each agency, where 

feasible and appropriate, shall seek the views of those who are likely to be affected, 

including those who are likely to benefit from and those who are potentially subject to such 

rulemaking. 

For 

formal international regulatory cooperation, such as standards setting, 

according to nonfederal stakeholders, they can directly observe 

international meetings and provide input in some cases. However, 

nonfederal stakeholders told us that high levels of resources are required 

to participate in international meetings, which can limit participation in 

practice. For informal international cooperation activities, nonfederal 

stakeholders said it is even more challenging to track and provide input 

into the agencies’ activities because some activities described to us by 

regulatory agencies precede the decision to regulate and therefore may 

not be transparent to the public. While it is generally challenging for 

nonfederal stakeholders to provide input into U.S. agencies’ international 

regulatory cooperation activities, it is particularly important that 

Nonfederal Stakeholders 

Report Challenges to 

Providing Input into 

Agencies’ International 

Regulatory Cooperation 

Activities
 

Page 18 GAO-13-588 International Regulatory Cooperation

stakeholders at least have the opportunity to participate and advise 

agencies when those activities are anticipated to lead to the development 

of regulations. However, further complicating nonfederal stakeholders’ 

efforts, there is no single source of public information on anticipated U.S. 

and foreign rulemakings with an international impact. For example, the 

Unified Agenda and OMB Regulatory Review Database both identify U.S. 

regulations that have an international impact. The Unified Agenda 

includes regulations under development or review, while the OMB 

Regulatory Review Database includes significant regulations submitted to 

OMB for review. In addition, the WTO maintains databases on certain 

member countries’ proposed regulations related to technical barriers to 

trade and sanitary and phytosanitary measures—namely those selfidentified as having potential trade impacts or involving divergence from 

international standards.

Agency officials we interviewed agreed that stakeholder involvement is 

important and nonfederal stakeholders are uniquely positioned to identity 

and call attention to unnecessary differences among U.S. regulations and 

those of its trading partners. Agencies and nonfederal stakeholders told 

us that the U.S.-Canada RCC has implemented practices to engage 

nonfederal stakeholders. For example, the 29 work plans that make up 

the RCC were developed in part from the response to a Federal Register

request for public comments concerning regulatory cooperation activities 

that would help eliminate or reduce unnecessary regulatory divergences 

in North America that disrupt U.S. exports. Stakeholder outreach activities 

are also included in the work plans. OMB is also taking steps to increase 

the transparency of agencies’ international regulatory cooperation 

activities and included new reporting requirements for agencies in 

Executive Order 13609. The order directs agencies that are required to 

submit a regulatory plan to include summaries of their international 

regulatory cooperation activities that are reasonably anticipated to lead to 

significant regulations.32 An agency official also cautioned it may not be 

realistic for agencies to report all international regulatory cooperation 

activities as many are informal in nature.

 

32Not all international regulatory cooperation activities result in regulations and not all 

regulations are significant. 
 

Page 19 GAO-13-588 International Regulatory Cooperation

Agency officials we interviewed reported that the outcomes from 

international regulatory cooperation can inform all phases of the 

rulemaking process, from affecting an agency’s decision whether or not to 

regulate in a particular area to implementing and enforcing regulations. 

According to an agency official, there is no bright line that separates 

international regulatory cooperation activities from regulatory programs. 

For example, U.S. agencies share scientific and technical information with 

their foreign counterparts, which can inform all stages of the rulemaking

process. In addition, information sharing can help inform an agency’s 

decision on whether or not to regulate a product. When countries have 

differences in regulations in a particular area, there are opportunities to 

coordinate on the science underlying regulatory decisions in a particular 

area. EPA Office of Chemical Safety and Pollution Prevention (OCSPP) 

officials said that for chemical safety regulations, countries are working 

within different statutory and regulatory frameworks and different levels of 

acceptance of risk that can make it difficult to reach full agreement on a 

regulatory approach. In such cases, sharing information with foreign 

counterparts can facilitate agreement on a common understanding of the 

issue or on underlying technical or scientific issues. According to officials 

that we interviewed, OCSPP also focuses on transparency and good 

regulatory practices, which lead to commonality between policies, work 

sharing on scientific reviews, and greater harmonization in the long term.

Some international regulatory cooperation activities, such as the 

development of international standards or practices, can inform and 

contribute to the development and issuance of a proposed regulation. 

Certain U.S. agencies reported that they coordinate with organizations 

that develop international standards and may use these standards when 

developing domestic regulations. For example, DOT’s Pipeline and 

Hazardous Materials Safety Administration (PHMSA) participates in the 

United Nations (UN) Transport of Dangerous Goods (TDG) 

Subcommittee, which develops UN Model Regulations for the 

Agencies Consider 

International 

Regulatory 

Cooperation and 

Competitiveness 

during Rulemaking in 

Different Ways

International Regulatory 

Cooperation Activities 

Inform Different Phases of 

Rulemaking 
 

Page 20 GAO-13-588 International Regulatory Cooperation

transportation of hazardous materials. In an effort to align with any 

changes to the UN Model Regulations, PHMSA considers these model 

regulations in a rulemaking every 2 years. As a result, related U.S. 

regulations are more closely aligned with trading partners and there are 

fewer country-unique regulations for businesses to comply with, which 

leads to improved safety results. According to PHMSA officials that we 

interviewed, when regulations are the same in different countries it 

enhances compliance and improves the efficiency of the transportation 

system by minimizing regulatory burdens and facilitating effective 

oversight. Similarly, Commerce officials pointed out that regulators often 

use common technical standards as the basis for regulation, which can 

reduce the burden on the regulated community.

Other international regulatory cooperation activities are related to the 

implementation of regulations, such as equivalency agreements that 

assure compliance with U.S. requirements and capacity building. For 

example, USDA’s Agricultural Marketing Service (AMS) manages 

equivalency agreements for organic food labeling. The U.S. equivalence 

arrangement with the EU allows organic products certified in Europe or 

the United States to be sold as organic in either region. According to AMS 

officials, equivalency agreements result in expanded market access, 

fewer duplicative requirements, and lower certification costs for organic 

products. Previously, businesses that wanted to trade organic products 

had to obtain separate certifications for both the United States and EU, 

which meant a second set of fees, inspections, and paperwork. Agencies 

also engage in capacity building and provide technical assistance to 

countries to help foreign businesses comply with U.S. regulations when 

exporting to the United States. For example, FDA developed a 

comprehensive international food safety capacity-building plan in 

response to a requirement in the FDA Food Safety Modernization Act. 

The plan establishes a strategic framework for the FDA, describes an 

approach that is based on prioritizing risks to U.S. consumers, and 

focuses on addressing system weaknesses working with foreign 

government and industry counterparts and other stakeholders. Agencies 

also engage in work-sharing arrangements with their foreign counterparts 

to gain efficiencies in the implementation of regulatory programs. For 

example, under the United States-Canada Beyond the Border Initiative, 

USDA’s Animal and Plant Health Inspection Service (APHIS) conducted a 

joint foot and mouth disease site visit in Colombia as part of the 

evaluation of Colombia’s request to export fresh beef. Coordinated 

inspections allow agencies to leverage resources with their foreign 

counterparts to fulfill their regulatory responsibilities. OIRA also engages 
 

Page 21 GAO-13-588 International Regulatory Cooperation

in activities to strengthen the capacity of developing countries in several 

contexts, including APEC and work with Brazil, Vietnam, and Morocco. 

Some international regulatory cooperation activities that U.S. agencies 

shared with us are on products that are not regulated by U.S. agencies. 

Agencies do not issue regulations through programs where participation 

is voluntary but still may coordinate with foreign counterparts. For 

example, DOE is working with other countries through the Efficient 

Electrical End-use Equipment (4E) Implementing Agreement on efficiency 

and performance criteria and metrics, test methods, and qualified testing 

laboratories for new technology for solid state lighting. DOE officials said 

coordination on solid state lighting is important, because without a 

common agreement, it would be more difficult for products to enter the 

world market. Standardized labeling also helps customers understand the 

product they are buying and how its efficiency compares with other 

products.

For regulations deemed significant under Executive Orders 12866 and 

13563, U.S. agencies are required to assess the costs and benefits, but 

there is no requirement for agencies to conduct a separate analysis on 

competitiveness impacts when developing regulations. Among the 

general principles of regulation under Executive Order 13563 is that the 

U.S. regulatory system should promote economic growth, innovation, 

competitiveness, and job creation. Moreover, according to executive 

orders on regulatory review, among the possible effects that agencies 

should consider are the significant adverse effects on the ability of U.S. 

companies to compete in domestic and foreign markets. Moreover, OMB 

Circular A-4’s discussion on global competitiveness states: “The role of 

Federal regulation in facilitating U.S. participation in global markets 

should also be considered. Harmonization of U.S. and international rules 

may require a strong Federal regulatory role. Concerns that new U.S. 

rules could act as non-tariff barriers to imported goods should be 

evaluated carefully.” Further, these executive orders and related guidance 

do not apply to independent agencies.33

 

33According to OMB officials, Executive Order 13579 recognizes that while not a 

requirement, independent agencies should follow these principles as well.

The concept of competitiveness 

is a general one, referring to the set of institutions, policies, and human 

and natural endowments that allow a country to remain productive.

While Executive Orders 

and Guidance Encourage 

U.S. Agencies to Consider 

Competitiveness Impacts 

during Rulemaking, There 

Is No Requirement to 

Conduct a Separate 

Analysis
 

Page 22 GAO-13-588 International Regulatory Cooperation

Depending on the circumstances, the focus of analysis could vary. Here, 

in the context of international regulatory cooperation, improvements to 

competitiveness might arise from lowering the cost of a firm’s compliance 

with other countries’ standards or expanding access of U.S. products to 

foreign markets. However, documenting the effect of the removal of 

barriers on firm cost and sales presents challenges because data on 

individual firm performance may not be available and because the effect 

of the regulatory action may be difficult to isolate. Still, in some cases, it 

may be possible to describe effects in terms of magnitude and direction.

When agencies develop regulations related to international activities, 

officials from five of the seven agencies in our study told us that they 

consider competitiveness as needed. Officials from two agencies in our 

study provided examples of analysis of competitiveness impacts in the 

rulemaking record. Agency officials said competitiveness impacts for 

some rulemakings are likely to be indirect and may not rise to the level of 

inclusion in the rulemaking record. For example, according to officials, 

APHIS’s regulations focus on preventing the introduction and spread of 

pests and diseases of livestock and plants. The officials explained it is 

difficult to point to any APHIS regulations that can be said to have a direct 

effect on the ability of U.S. businesses to compete in the marketplace. In 

another example, officials from DOT’s PHMSA said their regulations 

related to pipeline safety are for pipelines within the United States. When 

included in the rulemaking record, competitiveness is likely to be a 

secondary or tertiary effect in rulemaking analysis. For example, 

according to OAR officials, most OAR rulemakings have few if any direct 

impacts on competitiveness. These impacts, if any, would likely be 

secondary or indirect. They said that competitiveness analysis, when 

appropriate, might examine whether increased production costs for a U.S.

business may put it at a competitive disadvantage compared with a 

similar company in a different country that is not required to comply with a 

similar environmental regulation.

Some agency officials we interviewed said competitiveness impacts can 

be challenging to identify, difficult to quantify, and resource intensive to 

complete and that they do not have tools to consider competitiveness 

during rulemaking. According to DOT’s National Highway and Traffic 

Safety Administration (NHTSA) officials, NHTSA has never addressed the 

competitiveness of U.S. businesses in any of its analyses. NHTSA does 

not have tools for analyzing the effects of its safety standards on the 

competitiveness of U.S. businesses. For at least 10 years, NHTSA and 

DOT’s Volpe Center have attempted to create a consumer-marketing 

model to help estimate the impact of the fuel economy program on sales 
 

Page 23 GAO-13-588 International Regulatory Cooperation

and have been unsuccessful to date.34

However, officials from one agency we interviewed said that 

competitiveness impacts are assumed to exist when they are aligning 

regulations with trading partners, but agencies do not do a separate 

analysis. For example, according to PHMSA officials, PHMSA’s 

harmonization rulemakings are premised on the assumption that 

harmonized standards reduce costs for businesses and therefore reduce 

barriers to trade. Specific cost-benefit analysis, however, is generally 

associated with comparing the estimated costs of a regulation with the 

safety and efficiency benefits associated with a specific change and not 

directly associated with competitiveness of U.S. businesses. Further, the 

TBT Agreement explains that using international standards as the basis 

of a technical regulation adopted for a specified legitimate objective shall 

be rebuttably presumed to not create unnecessary obstacles to 

international trade.

They said that trying to determine 

the impact on competition of a relatively small safety standard, when 

NHTSA cannot do it for the enormous fuel economy standard, does not 

seem to be a good use of resources.

35

Officials from all U.S. agencies said they consider international standards 

during rulemaking, which can help facilitate trade. For example, NHTSA 

considers other countries’ standards and regulations when developing 

new regulations. The agency considers the research and test procedures 

that have already been developed internationally when considering how 

to develop Federal Motor Vehicle Safety Standards. Similarly, DOE 

officials said DOE’s Appliance and Equipment Standards Program 

regularly adopts (in whole or part) product test procedures (or test 

standards) developed by a broad range of nongovernmental standards 

organizations, such as the American National Standards Institute, the 

Institute of Electrical and Electronics Engineers, ASTM International,36

 

34The Volpe Center is part of DOT’s Research and Innovative Technology Administration.

Its mission is to improve the nation’s transportation system by anticipating emerging 

transportation issues and to serve as a center of excellence for informed decision making.

the 

35Legitimate objectives include: national security requirements; the prevention of 

deceptive practices; and protection of human health or safety, animal or plant life or 

health, or the environment. TBT Agreement, Art. 2.2 and 2.5. 

36ASTM International was formerly known as the American Society for Testing and 

Materials.

U.S. Agencies Report 

Considering International 

Standards during 

Rulemaking 
 

Page 24 GAO-13-588 International Regulatory Cooperation

Illuminating Engineering Society, and others. Many of these test 

standards are referenced in, or used as the basis for, standards 

developed by organizations, such as the International Electrotechnical 

Commission, ISO, or other international standards-setting organizations. 

Agencies may also consider approaches taken by other countries. For 

example, in the development of a crib safety regulation, CPSC staff 

reviewed requirements of existing voluntary and international standards 

related to cribs. The primary standards currently in effect are CPSC 

standards for full-size cribs, which reference the ASTM voluntary 

standard; a Canadian standard; a European standard; and an Australian 

and New Zealand standard. ASTM considered the existing international 

standards in the development of the current ASTM voluntary standard. 

The TBT Agreement includes requirements to use international standards 

or their relevant parts as the basis for technical regulation where available 

and appropriate; to participate in international standards development, 

within the limits of their resources; and to avoid unnecessary obstacles to 

trade.37 Similarly, under the National Technology Transfer and 

Advancement Act of 1995, agencies are required to use technical 

standards that are developed or adopted by voluntary consensus 

standards bodies unless they are inconsistent with applicable law or 

otherwise impracticable.38 If using standards other than voluntary 

consensus standards, agencies are also required to provide an 

explanation to OMB. Further, Executive Order 13609 on promoting 

international regulatory cooperation includes a requirement that for 

significant regulations that the agency identifies as having significant 

international impacts, agencies consider, to the extent feasible, 

appropriate, and consistent with law, any regulatory approaches by a 

foreign government that the United States has agreed to consider under a 

regulatory cooperation council work plan. DOT, CPSC, FDA, and USDA 

have some additional agency-specific documents related to considering 

international standards during rulemaking.39

 

37TBT Agreement art. 2.2, 2.4, and 2.6. 

38Pub. L. No. 104-113, § 12(d). 

39We have previously reported on CPSC’s efforts related to voluntary standards, including 

international standards. See: GAO, Consumer Product Safety Commission: A More Active 

Role in Voluntary Standards Development Should Be Considered, GAO-12-582. 

(Washington, D.C.: May 21, 2012).
 

Page 25 GAO-13-588 International Regulatory Cooperation

Agency officials that we interviewed identified seven factors that have the 

greatest impact on improving the effectiveness of international regulatory 

cooperation. Some of these factors can facilitate agencies’ efforts if 

present in international regulatory cooperation activities while others can 

also act as a barrier when absent. In an environment of constrained 

budgets, agencies may not be able to address the factors equally, so it is 

particularly important for agencies to focus on the factors that facilitate 

their efforts. Therefore, as part of our evaluation, we ordered the factors 

in table 3 below based on discussions and written responses from 

agencies.

Table 3: Key Factors Identified by Agencies that Affect International Regulatory Cooperation

Factor Description

Dedicated resources Agencies can develop relationships with foreign counterparts, monitor developments and 

attend meetings when resources for regulatory cooperation are made available.

Established processes Documented processes such as forums, international procedures, and other international 

mechanisms can govern certain international cooperation activities.

High-level leadership Leadership can set the direction, pace, and tone of agencies’ international regulatory 

cooperation activities.

Scientific and technical exchanges The sharing of scientific and technical information with foreign counterparts can support the 

enforcement of regulations through universal compliance requirements and testing but can also 

lay the groundwork for future coordination.

Stakeholder involvement Nonfederal stakeholders’ participation in regulatory cooperation can help identify opportunities, 

but the effectiveness of participants can depend on the needs of various nonfederal 

stakeholders. 

Statutory authority Statutory authority can encourage or restrict participation in certain international regulatory 

cooperation activities. 

Early and ongoing coordination Coordination prior to the promulgation of regulations can prevent the establishment of 

regulations with unnecessary differences, but international regulatory cooperation requires 

ongoing commitment to be most effective.

Source: GAO analysis of agency interviews.

Note: The factors are listed in order of the general priority expressed by agency officials in meetings 

with GAO.

As another part of our evaluation of these factors, we found that they 

align with each of the key features important for agencies to consider 

when implementing collaborative mechanisms. In September 2012, we 

identified features that agencies could benefit from considering when 

Key Factors Can 

Positively or 

Negatively Affect the 

Outcomes of 

International 

Regulatory 

Cooperation Activities
 

Page 26 GAO-13-588 International Regulatory Cooperation

implementing interagency collaborative mechanisms.40

Dedicated resources. Agencies in our study emphasized that 

international regulatory cooperation requires dedicated resources and 

long-term investments. Agency officials that we spoke with said that the 

initial stage of international regulatory cooperation is resource intensive 

because it includes developing relationships with foreign counterparts and 

addressing legal, policy, and technical differences. In our September 

2012 report, we concluded that resources are a key feature to 

collaboration because it takes time and resources to build trust among 

participants, set up ground rules for the process, attend meetings, 

conduct project work, and monitor the results of the work.

For example, we 

found that: (1) resources are a key feature because collaborative efforts 

can take time and resources in order to accomplish such activities as 

building trust among the participants, setting up the ground rules for the 

process, attending meetings, conducting project work, and monitoring and 

evaluating the results of work performed; (2) establishment of agreements 

in formal documents can strengthen an agency’s commitment to working 

collaboratively; and (3) leadership is important to all collaborative efforts, 

but agencies have said that transitions within agencies or inconsistent 

leadership can weaken the effectiveness of any collaborative mechanism. 

We used those features as criteria to determine whether the seven main 

factors that agencies and stakeholders identified as affecting international 

regulatory cooperation reflected consideration of each of those issues.

We applied these criteria by comparing agencies’ characterizations of the 

seven key factors affecting international regulatory cooperation to the 

specific questions identified in our 2012 report for agencies to consider 

when implementing collaborative mechanisms. That comparison 

demonstrated that one or more of the seven key factors corresponded to 

each of the features of effective collaborative mechanisms.

41

 

40These features include (1) outcomes and accountability; (2) bridging organizational

cultures; (3) leadership; (4) clarity of roles and responsibilities; (5) participants; (6) 

resources; and (7) written guidance and agreements. In our collaboration work, we define 

collaboration as any joint activity that is intended to produce more public value than could 

be produced when organizations act alone. We use the term collaboration broadly to 

include interagency activities that others have variously defined as cooperation, 

coordination, integration, or networking. See 

These agency 

officials also said that once the initial resources have been invested, 

GAO-12-1022 and GAO, Results-Oriented 

Government: Practices That Can Help Enhance and Sustain Collaboration among Federal 

Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005).

41GAO-12-1022. 
 

Page 27 GAO-13-588 International Regulatory Cooperation

reoccurring cooperation after implementation of regulations may be less 

resource intensive to maintain through monitoring of developments in 

foreign countries and by directly participating in formal and informal 

meetings. USDA Foreign Agricultural Service (FAS) officials also pointed 

out that it can take a long time before payoffs or results from resources 

invested in international regulatory cooperation become apparent.

Agency officials that we interviewed also identified some challenges to 

securing and sustaining resources for international regulatory cooperation 

activities. For example, officials said that international cooperation may be 

viewed as too resource intensive to inform each individual regulatory 

activity. Officials also said that investment in international regulatory 

cooperation is viewed in some agencies as optional if it conflicts with 

other priorities and responsibilities when the same staff members are 

needed for other regulatory activities. One FAS official said that one of 

the greatest resource constraints is securing the availability of regulators 

in his department. Agency officials said that their foreign counterparts 

also face resource constraints that may affect their participation in two 

ways. First, resource constraints may limit their ability to participate in 

international regulatory cooperation activities. Second, such constraints 

may encourage foreign counterparts to leverage their limited resources 

with the United States and other partners when the issues line up with 

their own priorities.

Officials identified some opportunities for leveraging funds from other 

agencies to participate in international activities on an ad hoc basis. To 

encourage compliance with the TBT Agreement, U.S. law authorizes the 

United States Trade Representative and the Secretary concerned to 

make grants to and enter into contracts with any other federal agency to 

assist that agency in implementing programs and activities such as 

participating in international standards-related activities.42

 

4219 U.S.C. § 2545.

For instance, 

one industry official said that agencies are going to have fewer resources 

and therefore should be interested in leveraging their resources with other 

countries as early as possible. Agency officials confirmed that there are 

opportunities for them to leverage funds from United States Agency for 

International Development (USAID) and State to participate in 

international meetings. In addition, USTR officials said that their agency is 

able to leverage funds that are not available to other U.S. agencies and 
 

Page 28 GAO-13-588 International Regulatory Cooperation

can match funds for regulators to meet with their foreign counterparts in 

an international setting, such as through APEC meetings. U.S. 

participation in international regulatory cooperation can be a multi-agency 

effort. However, officials from a different agency also cautioned that such 

funds tend to be limited to efforts that involve developing countries and 

expressed concern that they are unlikely to be used to support regulators’ 

participation with the EU. With reductions to the federal budget, the 

money available to support regulatory cooperation may shrink.

Established processes. According to agency officials, having defined 

long-term processes and accountability mechanisms in place for working 

with foreign counterparts can facilitate international regulatory 

cooperation. Officials also said that such established processes can 

increase transparency for stakeholders and better enable input. Agencies 

said that defined processes developed through international agreements, 

including forums, international procedures, and other international 

mechanisms, are helpful. Agreements, such as the WTO SPS 

Agreement, require members to consider international standards during 

their process to develop regulations. The WTO SPS Agreement generally 

obligates members to base their regulations on sanitary or phytosanitary 

measures on international standards from Codex, OIE, or the 

International Plant Protection Convention unless they have scientific 

justification or have determined a different level of protection through a 

risk assessment. In our September 2012 report, we concluded that the 

establishment of agreements in formal documents can strengthen an 

agency’s commitment to working collaboratively.43

High-level leadership. Agency officials told us in our interviews that 

high-level leadership within an agency and leadership from outside the 

agency can facilitate international regulatory cooperation, but a perceived 

lack of high-level commitment or changing priorities can serve as barriers. 

One academic expert said that the only way that international regulatory 

Similarly, officials from 

DOT’s PHMSA said established processes for the UN TDG 

Subcommittee facilitate their cooperative efforts. The OECD also has 

established processes on chemicals in their rules. The binding nature of 

OECD rules ensures all countries abide by the requirements to accept 

data from other OECD members, which helps advance its international 

regulatory coordination efforts.

 

43GAO-12-1022. 
 

Page 29 GAO-13-588 International Regulatory Cooperation

cooperation will work is with high-level attention from the White House, 

OMB, USTR, and the State Department. In addition, OMB officials we 

interviewed said high-level support and leadership is essential to the 

success of international regulatory cooperation. They also stressed that 

regulatory agencies must have buy-in themselves, rather than be coerced 

into international regulatory cooperation by outside agencies. Similarly, 

Commerce’s International Trade Administration (ITA) officials said that 

executive orders and presidential initiatives, such as Executive Order 

13609, the U.S.-Canada RCC, the U.S.-Mexico High Level Regulatory 

Cooperation Council, APEC leaders’ meetings, and the North American 

Leaders Summit, have increased visibility, encouraged action from the 

regulatory community, and prioritized events related to international 

regulatory cooperation. Agency officials said that commitment of 

resources is an indicator of top-level support. Agencies also said that 

active participation by agency leadership with foreign counterparts can 

expedite and facilitate progress at key points. FDA officials said that, in 

their experience, when the heads of agencies have an ongoing active 

relationship with their counterparts in foreign countries, international 

regulatory cooperation is more likely to produce results.

Agencies told us that it can be challenging when leadership priorities 

change, such as when a new administration establishes different 

priorities, because international regulatory cooperation activities are longterm efforts. Shifting political priorities can lead to short-term 

commitments that can make it difficult for agencies to see projects 

through to the end. Officials said that agencies need high-level 

commitment, but if it wanes agencies can be left part way into a long-term 

project. In our September 2012 report, we concluded that, given the 

importance of leadership to collaborative efforts, transitions and 

inconsistent leadership can weaken the effectiveness of any collaborative 

mechanism.44

Scientific and technical exchanges. Sharing scientific and technical 

information facilitates international regulatory cooperation and includes 

coordination on testing, enforcement, and compliance issues, but, as 

explained later, can also be restricted by statutory authority. The FTC 

provides technical assistance to other countries in developing their 

regulatory policies. When countries disagree on the appropriate policy or 

 

44GAO-12-1022. 
 

Page 30 GAO-13-588 International Regulatory Cooperation

standards, they can sometimes find agreement on the underlying 

scientific and technical basis for regulations. According to FDA officials, 

the regulations for medical products are more science based, while those 

for food are more culture based, so FDA has more success with 

international coordination on medical products. Collaboration and sharing 

of data can lay the groundwork for future coordination. An independent 

advisory agency developed a report that stated that the mutual trust 

between regulators is an opportunity for work sharing because agencies 

do not have to duplicate tests or science which allows them to share their 

workload with foreign counterparts, move limited inspectors or transfer 

other resources to areas of greater need. However, some statutes may 

restrict scientific and technical exchanges because of limits on the 

disclosure of information with foreign counterparts which is further 

discussed within the section on statutory authority. 

Stakeholder involvement. Agencies we interviewed identified 

coordination with nonfederal stakeholders, such as industry groups, 

academic experts, and consumer groups, as a facilitator of international 

regulatory cooperation. An FDA official said that nonfederal stakeholders 

may be uniquely positioned to identify unnecessary differences in 

regulations and standards between countries and help agencies prioritize 

which differences would be most meaningful to address from their 

perspective. For example, FTC officials said that in developing the work 

products of the International Competition Network (ICN) a significant 

number of business users and nongovernmental advisors bring attention 

to issues, provide outside perspectives, help produce work products, and 

encourage implementation, even though government agencies are the 

members that ultimately accept the work by consensus.

Some agency officials and nonfederal stakeholders reported challenges 

to stakeholder involvement. Regulatory cooperation can be more difficult 

to resolve when nonfederal stakeholders have conflicting viewpoints 

about regulations. For example, USDA officials said there can be 

challenges when consumer advocacy groups and business advocacy 

groups have different views that lead to lawsuits to prevent international 

regulatory alignment. USDA officials said that the support for a U.S.-

Canada pilot project for meat inspection was divided between businesses 

that supported it and consumer groups that did not. In addition, one 

industry group found that some regulatory agencies were unwilling to 

actively engage foreign counterparts and U.S. industries to discuss U.S. 

regulatory requirements that are adopted by other countries. A different 

industry representative said that a regulatory agency he works with 

independently created a division dedicated to international telecom issues 
 

Page 31 GAO-13-588 International Regulatory Cooperation

to work with foreign counterparts and developed a modular approval, 

which gives industry more flexibility and shortens the time for product 

approvals.

In addition, a consumer advocacy stakeholder said that it would be helpful 

to set government-wide policies and definitions through a notice and 

comment period. For example, federal agencies do not employ the same 

definition of “equivalency,” and it would be helpful if there was a specific 

government-wide policy that stated that the result of international 

regulatory cooperation cannot lower domestic standards.

Statutory authority. Agencies we interviewed said that statutory 

authority may facilitate or limit their international regulatory cooperation 

activities. For example, DOT PHMSA officials said that statutory authority 

may mandate agency participation in international standards 

organizations. An industry stakeholder said it would facilitate cooperation 

if the underlying statutory authorities of agencies clearly permitted them to 

engage in trade activities. However, when statutes are prescriptive 

regarding domestic or rulemaking requirements, they can limit agencies’ 

ability to make changes to regulations that align with a foreign trading 

partner. For example, agency officials said that statutes mandating use of 

specific technologies can remove the flexibility to coordinate with foreign 

counterparts. EPA officials also said that, in many instances, the Clean 

Air Act requirements may limit the degree to which domestic regulations 

can be altered to accommodate or conform to foreign or international 

standards or approaches. Statutes that mandate completion of 

rulemakings within short time frames can also limit agencies’ ability to 

engage in harmonization. For example, CPSC officials said it was 

challenging to work with other countries to reach consensus when CPSC 

had been mandated by the Consumer Product Safety Improvement Act of 

2008 to issue a large number of regulations in a short time frame, which 

limited the amount of time they had to work with foreign counterparts.

Some agency statutes may limit disclosure of company-specific 

information with foreign counterparts. This can prevent U.S. agencies 

from sharing certain reports and scientific information with trusted foreign 

counterpart agencies. In a previous report, we stated that, although the 

addition of section 29(f) to the Consumer Product Safety Information Act 

was intended to encourage information sharing, CPSC expressed 

concern that restrictive language in this section hindered its ability to 
 

Page 32 GAO-13-588 International Regulatory Cooperation

share information.45

Early and ongoing coordination. Early and ongoing coordination with 

foreign governments in emerging areas before regulations are in place 

may facilitate international regulatory cooperation. Agency officials we 

interviewed said early and ongoing efforts are important to maintain 

progress. OMB officials said it is easier to prevent unnecessary 

differences than remove existing differences in regulations. For example, 

CPSC attends multilateral forecasting sessions with other countries to 

engage foreign counterparts before the rulemaking and standards setting 

process begins. According to agency officials we interviewed, it is more 

efficient for CPSC to align and prevent different regulatory approaches 

with other jurisdictions before the U.S. notice and comment rulemaking 

process begins. In another example, State officials we interviewed said 

there is a need for international regulatory coordination to take place as 

early as possible, before too many regulations are established in each 

country. They said there are opportunities to avoid unnecessary 

differences in regulations for nanotechnology, which can be applied to 

many types of products. Currently, there are no entrenched regulatory 

systems that would hinder cooperation on developing new standards.

Industry officials also said that it is important to coordinate on 

requirements early by reviewing countries’ regulatory differences, 

because fundamental differences between countries may require 

changes on an issue-by-issue basis. They also urged early coordination 

because regulatory agencies in other countries are establishing standards 

when the manufacturing process has already been developed in the 

An official from EPA OCSPP said that an important 

first step to scientific and technical exchanges with foreign counterparts is 

removing existing legal, regulatory, or policy hurdles that limit or prohibit 

data sharing between governments. For example, NHTSA officials we 

interviewed said that they have many research, testing, and enforcement 

activities that include restrictions on the transfer of information, which has 

been a barrier to international regulatory cooperation. They said that 

when a company discovered defects in tires in Germany, the information 

was not immediately available in the United States to prevent injuries 

because of an information-sharing restriction. Agency officials also noted 

that, in addition to the removal of U.S. agency information-sharing 

restrictions, it is essential that the hurdles that exist in other countries also 

be removed.

 

45GAO-13-150. 
 

Page 33 GAO-13-588 International Regulatory Cooperation

United States, which does not work well for them within today’s markets. 

One academic representative we interviewed said it is much easier for 

agencies to coordinate with trading partners on new regulations than on 

existing regulations.

According to agency officials we spoke with, early and ongoing 

coordination with foreign counterparts also can identify issues that are not 

ready for international regulatory cooperation. It is important to coordinate 

early with their counterparts when there are differences between the 

openness of the United States’ and other countries’ rulemaking 

processes. Officials noted that, while other countries have the opportunity 

to comment whenever a U.S. regulation is proposed, U.S. agencies and 

nonfederal stakeholders may not have similar opportunities to comment 

on foreign regulations.

With trade expanding and regulatory challenges growing, in recent years 

the President and U.S. agencies have undertaken multiple initiatives to 

focus attention on the importance of international regulatory cooperation. 

While the executive order on promoting international regulatory 

cooperation focuses on reducing trade barriers by reducing unnecessary 

differences in regulations with U.S. trading partners, we found in our 

review that U.S. agencies carry out numerous and diverse international 

regulatory cooperation activities to improve the effectiveness of 

regulations, gain efficiencies, and avoid duplicating work. The examples 

agencies shared with us show that their efforts often achieve both trade 

and regulatory efficiency goals. Ultimately it is clear that international 

regulatory cooperation requires interagency coordination. No one U.S. 

agency has the expertise or processes to effectively conduct these 

activities. Not only must regulatory agencies collaborate with other U.S. 

agencies, but they need to effectively collaborate with their foreign 

counterparts and affected nonfederal stakeholders.

Overall coordination of international regulatory cooperation activities is 

now handled by discrete processes with somewhat different focuses. U.S. 

regulatory agencies focus primarily on their missions to protect public 

health and safety and the environment, while USTR and Commerce, 

among others, focus on trade. Therefore, it is important for the U.S. 

government to effectively coordinate these interagency activities. Our 

work at agencies engaged in regulatory cooperation efforts shows there 

are opportunities to augment existing guidance and mechanisms that 

could further promote and improve international regulatory outcomes. For 

example, U.S. regulatory agency officials emphasized the benefits of 

Conclusions 
 

Page 34 GAO-13-588 International Regulatory Cooperation

sharing information on lessons learned and best practices with their 

peers. However, they believe the current processes are designed for toplevel collaboration and do not sufficiently address the day-to-day 

implementation of international regulatory cooperation. U.S. agencies and 

nonfederal stakeholders also noted the importance of stakeholder input in 

the success of international regulatory cooperation. Yet it is challenging 

for stakeholders to stay apprised of agencies’ activities and therefore 

provide input to agencies. Key next steps could focus on identifying tools 

to measure outcomes as well as to document savings from more efficient 

use of government resources. In an environment of constrained 

resources it is even more important for agencies to share knowledge on 

the effective implementation of international regulatory cooperation.

To ensure that U.S. agencies have the necessary tools and guidance for 

effectively implementing international regulatory cooperation, we 

recommend that the Regulatory Working Group, as part of forthcoming 

guidance on implementing Executive Order 13609, take the following 

action:

• Establish one or more mechanisms, such as a forum or working 

group, to facilitate staff level collaboration on international regulatory 

cooperation issues and include independent regulatory agencies.

We provided a draft of this report to Commerce, CPSC, DOE, DOT, EPA, 

FTC, HHS, OMB, State, USDA, and USTR for their review and comment. 

We received written comments on the draft report from DOE, and CPSC 

in which they agreed with the recommendation to the RWG. Their 

comments are reprinted in Appendices III and IV. In an email received on 

July 30, 2013, the Deputy General Counsel, Office of Management and 

Budget, stated that OMB had no comments on the recommendation in 

this report. However, OMB provided technical comments which we 

incorporated as appropriate. Commerce, CPSC, DOE, FTC, HHS, State, 

USDA, and USTR also provided technical comments which we 

incorporated as appropriate. 

We are sending copies of this report to OMB (which chairs the RWG), 

Commerce, CPSC, DOE, DOT, EPA, FTC, HHS, State, USDA, USTR, 

and other interested parties. In addition, the report will be available at no 

charge on GAO’s website at http://www.gao.gov. 

Recommendation for 

Executive Action

Agency Comments 

and Our Evaluation
 

Page 35 GAO-13-588 International Regulatory Cooperation

If you or your staff have any questions about this report, please contact 

me at (202) 512-6806 or sagerm@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made key contributions to this report 

are listed in appendix IV.

Sincerely yours,

Michelle Sager

Director, Strategic Issues
Appendix I: Objectives, Scope, and 

Methodology

Page 36 GAO-13-588 International Regulatory Cooperation

Our objectives were to (1) provide an overview of regulatory agencies’ 

international cooperation activities, (2) examine ways that agencies 

incorporate outcomes from international regulatory cooperation activities 

and consider competitiveness during rulemaking, and (3) examine factors 

identified by agencies and nonfederal stakeholders that act as facilitators 

or barriers to international regulatory cooperation and considering 

competitiveness. To address these objectives, we selected seven U.S. 

regulatory agencies out of 60 U.S. agencies that are included in the 

Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified 

Agenda), that issued regulations with international impacts and four U.S. 

agencies with government-wide international coordination responsibilities.

Based on several sources we identified likely regulatory agencies that 

issue regulations related to international trade. For example, we reviewed 

the 2010 and 2011 Unified Agenda and data from the 2011 World Trade 

Organization (WTO) Technical Barriers to Trade (TBT) Information 

Management System. We also reviewed all major regulations from 2011.1

We categorized the regulations with an international impact into 

regulatory subject areas such as product safety, environmental, energy, 

transportation of products, food, medical devices, drugs, and aviation. 

The reason we categorized the regulations was to select groups of 

regulations that affect global trade in products. In addition, we excluded 

categories from our scope, such as taxation/taxes, patents, arms trade, 

international waters, and trade agreements. We also tested the 

databases used in agency selection by reviewing related documentation, 

interviewing knowledgeable agency officials, and tracing a sample of 

entries to source documents. We concluded the data were sufficiently 

reliable for the purposes of this report. We also considered 

recommendations from federal agency officials in selecting regulatory 

agencies. From these varied efforts, for our review we selected the

Department of Energy (DOE), Food and Drug Administration (FDA), 

Department of Transportation (DOT),2

 

1

The Congressional Review Act defines a major rule as one that has resulted in or is likely 

to result in (1) an annual effect on the economy of $100 million or more; (2) a major 

increase in costs or prices for consumers, individual industries, federal, state, or local 

government agencies, or geographic regions; or (3) significant adverse effects on 

competition, employment, investment, productivity, or innovation, or on the ability of U.S.-

based enterprises to compete with foreign-based enterprises in domestic and export 

markets. 5 U.S.C. § 804(2).

Environmental Protection Agency 

2

Also including subagencies National Highway Traffic Safety Administration (NHTSA) and 

the Pipeline and Hazardous Materials Safety Administration (PHMSA). 

Appendix I: Objectives, Scope, and 

Methodology 
Appendix I: Objectives, Scope, and 

Methodology

Page 37 GAO-13-588 International Regulatory Cooperation

(EPA),3 and Department of Agriculture (USDA)4 as well as two 

independent regulatory agencies including the Consumer Product Safety 

Commission (CPSC) and the Federal Trade Commission (FTC). These 

views are not generalizable to all U.S. agencies. Based on our 

background research and suggestions from federal agencies we selected 

four agencies with government-wide international coordination 

responsibilities: Office of Management and Budget (OMB), Office of the 

United States Trade Representative (USTR), Department of Commerce 

(Commerce), and Department of State (State).5 Furthermore, using 

criteria based on our September 2012 report on interagency collaborative 

efforts, we also compared agencies’ documents and testimonial evidence 

about their international regulatory cooperation activities to the seven key 

features that we found agencies should consider when implementing 

collaborative mechanisms to corroborate the agencies’ findings.6

To obtain viewpoints outside of government, we chose 11 U.S. nonfederal 

stakeholders which consisted of academics, organizations representing 

businesses, consumer advocacy groups, standards setting organizations 

and industry representatives, based on their recent reports or from 

comments they made on international regulatory cooperation. We 

originally selected one of each type of nonfederal stakeholder group 

based on published views on international regulatory cooperation and 

recommendations from agencies in our study but decided to add more 

nonfederal stakeholders to our selection criteria to represent a diverse 

range of members that represent business promotion, consumer 

advocacy perspectives and neutral parties. These views are not 

generalizable, but provided insights on international regulatory 

cooperation.

 

3

Also including subagencies Office of Air and Radiation (OAR) and the Office of Chemical

Safety and Pollution Prevention (OCSPP).

4

Also including subagencies Animal and Plant Health Inspection Service (APHIS), 

Agricultural Marketing Service (AMS), Food Safety and Inspection Service (FSIS), and 

Foreign Agricultural Service (FAS).

5

USDA, which is a regulatory agency, also has a coordinating role as the national enquiry 

point for the World Trade Organization’s Agreement on the Application of Sanitary and 

Phytosanitary Measures. 

6

GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012).
Appendix I: Objectives, Scope, and 

Methodology

Page 38 GAO-13-588 International Regulatory Cooperation

For federal agencies and nonfederal stakeholders chosen for this 

engagement, we conducted interviews and gathered documentation such 

as concrete examples, facilitators, barriers, goals, outcomes, and 

stakeholder involvement related to international regulatory cooperation 

activities, rulemaking and global competiveness. We used this 

documentary and testimonial evidence to identify government-wide and 

agency-specific requirements related to rulemaking outcomes for 

international regulatory cooperation and global competitiveness and 

determined how these selected agencies consider related issues. After 

analyzing our evidence for common themes and patterns, we developed 

a summary document of factors that are facilitators or barriers to 

international regulatory cooperation and held two meetings for agency 

officials to reflect upon the meaning of the factors, and confirm their

importance. We summarized information gathered at these group 

meetings to better describe the agencies’ perspectives. Throughout this 

report, we use specific, selected examples to illustrate agency processes 

and practices.

The scope of our inquiry was not comprehensive, generalizable, or 

designed to be a complete catalog of international regulatory activities. 

We conducted this performance audit from March 2012 to August 2013, 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 39 GAO-13-588 International Regulatory Cooperation

Agencies provided us with examples of their international regulatory 

cooperation activities. The examples below illustrate the types of activities 

that agencies engage in to fulfill their regulatory missions and are not 

meant to be a comprehensive catalog of agency activities in this area.

Agencies share information with their foreign counterparts on scientific 

data and regulatory approaches.

Agency: Environmental Protection Agency’s (EPA) Office of Chemical 

Safety and Pollution Prevention (OCSPP)

Description: OCSPP shares information with the North American Free 

Trade Agreement (NAFTA) partners and the international organization 

Codex on its Pesticide Tolerance Crop Grouping Revisions Program. 

EPA regulates pesticides by setting limits on the amount of pesticides that 

remain in or on foods marketed in the United States under the Federal 

Food, Drug, and Cosmetic Act. The Pesticide Tolerance Crop Grouping 

Revisions Program enables the establishment of tolerances for a group of 

crops based on residue data for certain crops that are representative of 

the group. Representatives of a crop group or subgroup are those crops 

whose residue data can be used to establish a tolerance on the entire 

crop group or subgroup.

The project involves several interrelated multiyear efforts, including (1) 

one with NAFTA partners in Canada and Mexico to revise the existing 

crop groups in EPA’s regulations (40 CFR 180.41) to add new crops and 

create new groups and subgroups; and (2) one in which NAFTA partners 

are working with international stakeholders to modify the Codex crop 

groups, to support global trade and the use of data extrapolation. 

Petitions to revise the NAFTA crop grouping regulations are developed by 

the International Crop Grouping Consulting Committee, a group of more 

than 180 crop, agrichemical, and regulatory experts representing more 

than 30 countries and organizations. NAFTA partners also are working 

cooperatively with international stakeholders to revise the Codex system 

of classification of foods and animal feeds and to revise the Codex crop 

groups. Involvement by NAFTA member countries in the Codex process 

should help standardize commodity terminology and crop groupings 

within the global context.

Appendix II: Examples of International 

Regulatory Cooperation Activities

Information Sharing 

and Scientific 

Collaboration 

Pesticide Tolerance Crop 

Grouping Revisions 

Program
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 40 GAO-13-588 International Regulatory Cooperation

Outcomes: Approved revisions to crop group regulations are formalized in 

the United States through rulemaking. EPA is currently working on its 

fourth crop grouping proposed regulation. Crop groupings also facilitate 

international trade, including the market for pesticide products and the 

crops treated. Pesticides with established tolerances in the United States 

can be sold for use on crops grown in other countries that intend to import 

those crops to the United States. Crops imported in the United States with 

pesticide residues that do not have an established U.S. tolerance are 

subject to enforcement action.

Agency: EPA’s Office of Chemical Safety and Pollution Prevention 

(OCSPP)

Description: The United States has participated in the OECD Joint 

Meeting of the Chemicals Committee and Working Party on Chemicals, 

Pesticides and Biotechnology, an organization with over 30 member 

countries, for more than 30 years. Specific information sharing activities 

include:

• OECD eChem Portal: OCSPP shares information on industrial 

chemicals and various data systems. The OECD eChem Portal allows 

simultaneous searching of reports and datasets by chemical name 

and number and by chemical property. The portal provides direct links 

to collections of chemical hazard and risk information prepared for 

government chemical review programs at the national, regional, and 

international levels. The portal also provides, when available, 

classification results according to national/regional hazard 

classification schemes or to the Globally Harmonized System of 

Classification and Labeling of Chemicals.

• OECD (Quantitative) Structure-Activity Relationships [(Q)SARs] 

Toolbox: OCSPP’s (Q)SARs are methods for estimating properties of 

a chemical from its molecular structure. The toolbox is a software 

application for governments, chemical industry, and other nonfederal 

stakeholders to fill gaps in (eco)toxicity data needed for assessing the 

hazards of chemicals.

Outcomes: According to EPA, these tools and approaches reduce 

compliance costs for nonfederal stakeholders, facilitate work sharing for 

regulators, and help avoid costly, duplicative testing by ensuring that the 

data developed and submitted in one country can be used by other 

countries in reaching their regulatory decisions. These activities do not 

directly result in rulemakings, but can inform rulemaking activities.

Organisation for Economic 

Co-operation and 

Development (OECD) 

Chemical Safety
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 41 GAO-13-588 International Regulatory Cooperation

Agency: Consumer Product Safety Commission (CPSC)

Description: CPSC participates in an international pilot alignment initiative 

with staff from the central consumer product safety authorities of 

Australia, Canada, the European Union, and the United States. This ad 

hoc group is not aligned formally with any existing multilateral forum. The 

participants are to seek consensus positions on the hazards to children 

and their potential solutions for three products: corded window coverings, 

chair-top booster seats, and baby slings. The goal of this initiative is to 

bring about effective, aligned safety requirements for these products to 

reduce injuries and save lives. The consensus positions could be 

considered and developed for implementation in each jurisdiction, 

according to the jurisdiction’s preferred model, whether through regulation 

or voluntary standards. Officials said that the consensus papers for baby 

slings and chair-top booster seats are in progress.

According to CPSC officials, the PAI jurisdictions worked for 18 months to 

reach consensus positions on corded window coverings, but the project 

fell short of CPSC’s expectations. Officials said that the technical teams 

from five jurisdictions agreed in principle that “no exposed cords” was the 

best solution to the strangulation hazard, but the European Commission 

had already publicly expressed an opposing position regarding the 

elimination of cords. CPSC officials said that when the PAI work began, 

the European Commission had already moved into policy development 

and soon thereafter issued a mandate to the European Committee on 

Standardization explicitly permitting safety devices to keep exposed cords 

out of reach of children. As a result, the consensus paper recognized “no 

exposed cords” as the best solution but did not call for their elimination as 

a consensus approach.

Outcomes: According to CPSC officials, the PAI can result in similar 

product safety requirements at a high level of safety among the 

jurisdictions participating in the initiative.

Agencies participate in international standards-setting bodies and 

incorporate international standards into rulemaking as appropriate.

Pilot Alignment Initiative 

(PAI) on Consumer 

Product Safety

Development and Use 

of International 

Standards 
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 42 GAO-13-588 International Regulatory Cooperation

Agencies: Department of Transportation’s (DOT) National Highway Traffic 

Safety Administration (NHTSA) and Environmental Protection Agency’s 

(EPA) Office of Air and Radiation (OAR)

Description: WP.29 is a permanent working party created more than 50 

years ago in the United Nations (UN) that administers three international 

agreements on motor vehicles: (1) the 1958 Agreement concerning the 

adoption of uniform technical prescriptions for wheeled vehicles, 

equipment, and parts which can be fitted and/or be used on wheeled 

vehicles and the conditions for reciprocal recognition of approvals granted 

on the basis of these prescriptions, (2) the 1997 Agreement concerning 

the adoption of uniform conditions for periodical technical inspections of 

wheeled vehicles and the reciprocal recognition of such inspections, and 

(3) the 1998 Agreement concerning the establishing of global technical 

regulations for wheeled vehicles, equipment, and parts which can be 

fitted and/or be used on wheeled vehicles. The WP.29 develops Global 

Technical Regulations that are used in member countries’ regulations and 

works as a global forum allowing open discussions on motor vehicle 

regulations. NHTSA and OAR participate in the development of global 

technical regulations. Nongovernmental organizations may also 

participate in a consultative capacity in WP.29 or in its working groups.

Outcomes: NHTSA officials said WP.29 participation contributes to safety 

in the United States because NHTSA leverages research with other 

countries. Global Technical Regulations increase alignment between 

countries. As a result, manufacturers have fewer country-specific 

regulations to comply with when participating in foreign markets. NHTSA 

uses Global Technical Regulations in rulemaking. For example, NHTSA 

issued a final rule in August 2012 on motorcycle brake systems safety 

standards to add and update requirements and test procedures and to 

harmonize standards with a global technical regulation for motorcycle 

brakes.

OAR officials said that OAR participated in an effort that focused on test 

procedures for off-highway construction vehicle engines. According to 

officials, this effort was undertaken after the completion of a domestic 

regulation. U.S. manufacturers supported using U.S. regulation as the 

basis of the Global Technical Regulation because U.S. manufacturers sell 

equipment internationally, and complying with one set of regulations 

reduces their fixed costs. Over 5 years OAR successfully worked within 

the WP.29 to make the U.S. regulation the basis of the WP.29 Global 

Technical Regulations. As a result, it has become the de facto standard 

around the world.

World Forum for the 

Harmonization of Vehicle 

Regulations (WP.29)
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 43 GAO-13-588 International Regulatory Cooperation

Agency: Department of Transportation’s (DOT) Pipeline and Hazardous 

Materials Safety Administration (PHMSA)

Description: PHMSA participates in the TDG Subcommittee, which, 

according to PHMSA, is facilitated by two treaties: the Chicago 

Convention on International Civil Aviation and the International 

Convention for the Safety of Life at Sea. Officials said the TDG 

Subcommittee was established because there was a need for 

international coordination on the transport of dangerous goods. 

Participants in the TDG Subcommittee include 29 countries with voting 

status and numerous countries and nongovernmental organizations with 

observer status. The TDG Subcommittee reviews proposals from voting 

member countries and observers in relation to amendments to the UN 

Model Regulations and issues relevant to its work program. PHMSA 

represents the United States at these meetings and formulates U.S. 

positions based on feedback from U.S. industry, the public, and other 

government agencies. PHMSA ensures coordination on U.S. positions, 

taking into account the interests of the DOT administrations and other 

government agencies. PHMSA’s staff provides the technical support and 

resources to ensure that the positions taken are sound and justified 

based on pertinent data, technical analyses, and safety rationales.

Outcomes: PHMSA considers the standards developed by the TDG 

Subcommittee in a rulemaking every 2 years in an effort to harmonize 

with international changes. For example, in January 2013, PHMSA issued 

a final regulation on harmonization with international standards for 

hazardous materials. PHMSA amended the Hazardous Materials 

Regulations to maintain alignment with international standards by 

incorporating amendments, including changes to proper shipping names, 

hazard classes, packing groups, special provisions, packaging 

authorizations, air transport quantity limitations, and vessel stowage 

requirements. The resulting cooperation leads to aligned regulations with 

trading partners, fewer differences in regulations businesses must comply 

with, and improved safety results (e.g., common labels for hazardous 

materials). Harmonization of international and domestic standards 

enhances compliance and improves the efficiency of the transportation 

system by minimizing regulatory burdens and facilitating oversight. 

International harmonization of hazardous materials regulations plays a 

significant role in enhancing safe transportation through improved 

regulatory consistency.

UN Subcommittee on the 

Transport of Dangerous 

Goods (TDG 

Subcommittee) 
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 44 GAO-13-588 International Regulatory Cooperation

Agency: Federal Trade Commission (FTC)

Description: In October 2001, the FTC, Department of Justice (DOJ), and 

13 other antitrust agencies founded the ICN to provide a venue for 

agencies that regulate competition issues worldwide to work on 

competition issues of mutual interest. The ICN has a broad 

membership—127 agencies from 111 jurisdictions, which includes most 

of the world’s competition agencies. The ICN works exclusively on 

competition issues; develops consensual, nonbinding recommendations 

and reports to bring about procedural and substantive convergence; and 

provides a significant role for nongovernmental advisors from the 

business, legal, consumer, and academic communities, as well as 

experts from other international organizations. The ICN is organized into 

working groups composed of agencies and nongovernmental advisors. 

Current working groups address unilateral conduct, mergers, cartels, 

agency effectiveness, and competition advocacy. The FTC led the merger 

working group’s work on notification and procedures, which developed a 

set of eight guiding principles and 13 recommended practices for merger 

notification and review.

Outcomes: A major accomplishment of the ICN is that numerous 

members adopted key aspects of ICN recommended practices, such as 

those concerning merger thresholds. According to FTC officials, the 

objective was to enhance the effectiveness of each jurisdiction’s merger 

review practices and processes and promote procedural convergence, 

thereby reducing unnecessary private and public costs and burdens 

associated with merger review. FTC officials said FTC has not done any 

rulemaking to implement the ICN recommendations because the 

recommendations are consistent with U.S. approaches to merger 

notification and review processes. 

In some cases, the United States may enter an agreement with another 

country to recognize other’s regulations and deem them equivalent to 

those of the United States.

Agency: United States (USDA) Agricultural Marketing Service (AMS)

Description: The AMS manages equivalency agreements for organic food 

labeling. For example, the United States has an equivalency arrangement 

with the European Union (EU), generally referred to as the Partnership, 

under which organic products certified in Europe or the United States may 

International Competition 

Network (ICN)

Equivalency 

Agreements 

National Organic Program 

(NOP) Equivalency 

Agreements
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 45 GAO-13-588 International Regulatory Cooperation

be sold as organic in either region. For retail products, labels or stickers 

must state the name of the U.S. or EU certifying agent and may use the 

USDA organic seal or the EU organic logo. Under the Partnership, 

according to USDA, the EU and the United States agreed to work on a 

series of technical cooperation initiatives to promote organic production 

and establish common practices for assessing and recognizing organics 

programs of third countries.

Outcomes: According to USDA officials, the EU-U.S. organic equivalency 

arrangement reduces the cost of certification for organic producers and 

handlers because producers and handlers only need to be certified under

one standard (either USDA organic regulations or EU organic regulations) 

but can now access and sell in both markets. Another outcome is that 

considering the respective countries’ standards as “equivalent” facilitates 

international trade of organic products. According to AMS officials, 

equivalency agreements will result in expanded market access; reduce 

duplicative requirements and lower certification costs for the trade in 

organic products; and decrease the burden of administration. The 

agreements are also expected to open new possibilities for trade. 

Previously, operations that wanted to trade organic products on both 

sides of the Atlantic had to obtain separate certifications to meet both 

standards, which meant a second set of fees, inspections, and 

paperwork. Additionally, in most cases, the Partnership will provide 

exporters the opportunity to serve both the U.S. and EU markets from a 

single inventory of organic products.

Agency: USDA Food Safety and Inspection Service (FSIS)

Description: Food safety equivalency evaluations are based on provisions 

in the Agreement on the Application of Sanitary and Phytosanitary 

Measures, which appears in the Final Act of the Uruguay Round of 

Multilateral Trade Negotiations, signed in Marrakech April 15, 1994. 

Under the agreement, World Trade Organization (WTO) member 

countries shall accord acceptance to the sanitary and phytosanitary 

measures of other countries (even if those measures differ from their own 

or from those used by other member countries trading in the same 

product) if the exporting country demonstrates to the importing country 

that its measures achieve the importer’s appropriate level of sanitary and 

phytosanitary protection.

FSIS makes determinations of equivalence by evaluating whether foreign 

food regulatory systems meet the level of protection provided by the U.S. 

Equivalence 

Determinations for the 

Import of Meat, Poultry, 

and Egg Products
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 46 GAO-13-588 International Regulatory Cooperation

domestic system. FSIS evaluates foreign food regulatory systems for 

equivalence through document reviews, on-site audits, and port-of-entry 

re-inspection of products at the time of importation. FSIS regulations list 

46 countries as eligible to export meat, 9 countries as eligible to export 

poultry, and 2 countries as eligible to export egg products to the United 

States. 

Outcomes: According to FSIS officials, the equivalency determination 

program has several benefits. One benefit is that the equivalence process 

requires communication and participation by U.S. regulators with the 

regulators in the country seeking (or already having) equivalence, which 

usually leads to positive relationships between the two countries and 

other intangible benefits. Another benefit to U.S. businesses is that it 

gives them more market capacity where they obtain raw materials, 

finished products, or both, which provides for potential costs savings 

through the use of these additional choices for eventual sale to U.S. and 

other consumers. U.S. consumers benefit because countries determined 

to be equivalent are providing meat, poultry, and egg products that are as 

safe as domestic products because the products meet U.S. appropriate 

levels of protection. These additional products may also be less 

expensive than products produced with U.S.-sourced ingredients.

Most agencies in our study provide technical assistance to developing 

countries. Agency officials said they work with countries to strengthen 

their regulatory systems, among other reasons, to improve safety of 

products imported into the United States.

Agency: FDA

Description: FDA undertakes activities to improve the capacity of 

governments to manage, assess, and regulate products within 

increasingly complex supply chains. According to FDA officials, FDA 

works to strengthen the global regulatory system and is a source of 

expertise that engages in global dialogue and initiatives with regulatory 

counterparts, development agencies, and global health partners. FDA is 

developing an operating model that relies on building a global safety net 

using four principles: global coalitions, global data systems, enhanced 

risk analysis capacities, and leveraging the efforts of public and private 

third parties. FDA’s Global Engagement Report outlines how FDA 

supports and collaborates with regulatory systems around the globe. 

While neither mandated nor funded as an international development or 

Strengthening 

Capacity of 

Developing Countries

Food and Drug 

Administration (FDA): 

Strengthening Global 

Regulatory Systems and 

Capacity
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 47 GAO-13-588 International Regulatory Cooperation

training organization, FDA works with bilateral and multilateral partners, 

domestically and internationally, to strengthen regulatory systems 

capacities and competencies in various parts of the world in an effort to 

ensure products that will be imported into the United States will be made 

safer and supply lines more secure. Examples of some of FDA’s efforts 

include development of information-sharing platforms and the provision of 

evidence tools and expertise that contribute to strengthening regulatory 

systems. 

• In response to Section 305 of the FDA Food Safety Modernization Act 

(FSMA), the FDA developed an international food-safety capacitybuilding plan. The plan establishes a strategic framework for the FDA 

and presents an approach based on prioritizing risks to U.S. 

consumers. It focuses on addressing weaknesses in a food safety 

system in partnership with foreign governments, industry 

counterparts, and other stakeholders.

• FDA supported the World Health Organization (WHO) in developing a 

global monitoring and surveillance system for substandard, falsified, 

and counterfeit medical products. The system was piloted in 10 

countries over 3 months in 2012. This system will be scaled up 

globally in the coming year.

• FDA is actively involved in efforts to strengthen regulatory capacity 

through its joint efforts with the World Bank, the WHO, the Gates 

Foundation, Asia-Pacific Economic Cooperation (APEC), the African 

Union, and others in the private and public sectors. By bringing its 

regulatory and scientific expertise to these efforts, FDA can better 

leverage the expertise of its partners to engage more efficiently and 

broadly in enhancing regulatory capacity globally. Examples of such 

initiatives include the World Bank/APEC initiative on food-safety 

capacity building and the World Bank/Gates Foundation/WHO/African 

Union efforts to enhance and rationalize regional regulatory capacity 

in various African economic communities, starting with the East 

African community.

Agency: FTC

Description: According to FTC officials, the FTC, in coordination with, 

among others, USAID, U.S. Trade and Development Agency, and the 

Department of Commerce, establishes relationships with developing 

countries and provides technical assistance. FTC helps countries develop 

and enhance their regulatory frameworks by encouraging convergence 

with international standards. FTC’s technical assistance program helps 

explain how competition, truthful advertising and marketing, and sensible 

Federal Trade Commission 

(FTC) Technical 

Assistance 
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 48 GAO-13-588 International Regulatory Cooperation

privacy frameworks advance economic efficiency, consumer welfare, and 

consumer choice. To this end, FTC assists developing countries in their 

transition to market-based economies and their development of 

competition and consumer protection agencies and sharing approaches 

to enforcement that are consistent with this goal. As part of its efforts, the 

agency routinely provides input to its foreign counterparts about the 

drafting and adopting of domestic legislative frameworks regarding 

competition, consumer protection, and privacy. FTC also works to build 

the capacity of its foreign counterparts to implement these frameworks 

and promote their proper enforcement.

Agency: APHIS

Description: APHIS participates in international regulatory capacity 

building to help other regulatory entities meet U.S. standards and protect 

health. Officials said APHIS actively builds international partners and 

meets with foreign regulatory officials bilaterally and multilaterally. For 

example, APHIS runs six to seven courses a year where it invites foreign 

officials to the United States for training on U.S. processes. APHIS 

officials said that APHIS annually trains 100 to 150 individuals from other 

countries. The officials said these trainings provide education and 

resources to foreign counterparts and build a network of individuals to 

support U.S. efforts worldwide and help other countries comply with U.S. 

regulations. APHIS also participates in multilateral capacity building on 

SPS. Officials said, under the SPS agreement, there is a responsibility to 

work with developing countries and APHIS has officials located overseas 

who informally work with partners on a daily basis. APHIS also has formal 

training programs overseas and in the United States.

Agencies work with foreign counterparts on projects to share resources to 

implement regulations and avoid duplicating efforts.

Agency: FDA

Description: FDA partners with foreign counterparts to coordinate on 

inspection activities. Foreign counterparts include:

• European Medicines Agency (EMA): Significant opportunities exist for 

FDA and EMA to leverage their inspection resources, and they are 

exploring this potential through a series of activities. They observed 

Animal and Plant Health 

Inspection Service 

(APHIS) Capacity Building

Work Sharing

FDA Coordination on 

Inspections 
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 49 GAO-13-588 International Regulatory Cooperation

each other’s inspections and jointly inspected manufacturing sites in 

the United States and the European Union (EU). Through this work, 

FDA and EMA are building a foundation for understanding, trust, and 

data-driven decisions in the area of inspections.

• EMA and Australia’s Therapeutic Goods Administration: In 2009, FDA 

joined the EMA and Australia’s Therapeutic Goods Administration to 

conduct a pilot program—the Active Pharmaceutical Ingredient 

Inspection Pilot—to demonstrate the potential for leveraging their 

inspection resources. Before the pilot, these agencies had been 

conducting separate inspections at the same overseas manufacturing 

sites—often within just months of one another—to assure that the 

safety and quality of the drugs were not jeopardized by poor 

manufacturing practices. Under the pilot, the three agencies planned 

and conducted joint inspections at participating foreign facilities and 

shared information from inspections they had conducted over the past 

2 to 3 years. These exchanges have allowed FDA to redeploy 

inspection resources and alerted FDA to sites requiring heightened 

scrutiny. Since then, FDA has engaged in similar projects with 

additional counterparts.

• Health Canada: FDA also works with Canada on Third-Party 

Inspection/Audits. To enable closer regulatory cooperation, FDA and 

Health Canada (HC) initiated the Pilot Multi-purpose Audit Program in 

2006. The pilot explored the potential benefits to medical device 

manufacturers and the agencies of using a single third party for 

inspections audits to simultaneously meet FDA and HC regulatory 

requirements for systems quality. It was anticipated that a 

multipurpose audit could reduce the overall time spent on site by an 

official agency audit/inspection team, thus reducing the regulatory 

burden for industry. FDA and HC conducted 11 joint audit/inspections 

under the pilot; 10 of these were assessed for program benefits. The 

results showed that the joint approach reduced the time-in-facility 

spent at participating manufacturers by about one-third, on average, 

compared with the estimated time required for separate FDA and HC 

audits/inspections. In addition, FDA and HC gained a better 

understanding of their auditing/inspection approaches, providing a 

foundation for leveraging inspection resources in the future.

• New Zealand’s Ministry for Primary Industries: In December 2012, 

FDA signed an international arrangement with New Zealand’s Ministry 

for Primary Industries recognizing each other’s food safety systems as 

providing comparable degrees of food safety assurance. This 

arrangement was reached after a significant amount of time was 

spent by both parties working on regulatory systems recognition 

assessments. Systems recognition involves reviewing a foreign 

country’s food safety regulatory system to determine if it provides a 
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 50 GAO-13-588 International Regulatory Cooperation

similar set of protections to that of FDA and that the food safety 

authority provides similar oversight and monitoring activities for food 

produced under its jurisdiction. Outcomes of these reviews may be 

used by FDA to make risk-based decisions regarding foreign 

inspections, admitting product into the U.S., and follow-up actions 

when food safety incidents occur .

Outcomes: Coordinated inspections allow FDA to leverage resources with 

their foreign counterparts to fulfill their regulatory responsibilities.

Agency: USDA’s Animal and Plant Health Inspection Service (APHIS)

Description: As part of the United States-Canada Beyond the Border 

Initiative, APHIS and Canada conducted a joint site visit in Colombia for a 

foot and mouth disease evaluation and produced a joint report as part of 

the evaluation of Colombia’s request to export fresh beef in October 

2011. The United States and Canada are developing procedures for 

conducting future joint site visits and the exchange of information related 

to animal health evaluations. APHIS and Canada will also be identifying 

other opportunities to share evaluation results.

Outcomes: According to APHIS officials, outcomes could involve the 

United States and Canada developing risk evaluations that are based in 

part on a joint site visit.

Agencies cooperate with foreign counterparts on voluntary programs that 

are not part of agencies’ regulations.

Agency: Department of Energy (DOE)

Description: DOE’s international coordination on solid state lighting is 

done in large part through the International Energy Agency (IEA) Efficient 

Electrical End-Use Equipment (4E) Implementing Agreement, which was 

launched in 2008 and undertakes a range of analytical and information 

gathering and dissemination activities related to government regulation 

and labeling of appliances and equipment. The IEA was established 

under the Agreement on International Energy Program. Thirteen countries 

from the Asia-Pacific, Europe, North America, and Africa have joined 

together under the forum of 4E to share information and transfer 

experience to support good policy development in the field of energy 

Joint Animal Health Site 

Visits to Third Countries

Voluntary Programs

Efficient Electrical Enduse Equipment 

Implementing Agreement, 

Solid State Lighting Annex
Appendix II: Examples of International 

Regulatory Cooperation Activities

Page 51 GAO-13-588 International Regulatory Cooperation

efficient appliances and equipment. 4E also initiates projects designed to 

meet the policy needs of participants, enabling better informed policy 

making.

Officials said they worked with the 4E Annex on Solid State Lighting for 

several years on performance characteristics and testing procedures 

during which time they developed a network of laboratories that would 

perform independent testing that could be voluntarily adopted by foreign 

governments. Solid state (or LED) lighting is a new technology that has 

cost and performance characteristics that are developing rapidly. The 

goal of the annex is to develop simple tools to help government and 

consumers worldwide identify which solid state lighting products have the 

necessary efficiencies and quality levels to reduce the amount of energy 

currently consumed by artificial lighting. DOE is working with other 

countries to identify efficiency and performance criteria and metrics, test 

methods, and qualified testing laboratories that might be used in product 

labeling or standards activities related to these products.

Outcomes: According to DOE officials, this coordination is important 

because the adoption of performance standards and test procedures will 

help determine the products that can be marketed and sold around the 

world. They said without a common agreement on key characteristics for 

this new technology, it would be difficult for products to enter the world 

market. Standard labeling helps customers understand the product they 

are buying and how its efficiency compares with other products. The 

results of cooperation on solid state lighting will not necessarily be 

reflected in DOE’s regulations. DOE does not regulate this product at this 

time, although it has proposed a test procedure that might be used to 

support the Energy Star program or other initiatives.
Appendix III: Comments from the Department 

of Energy

Page 52 GAO-13-588 International Regulatory Cooperation

Appendix III: Comments from the 

Department of Energy
Appendix IV: Comments from the Consumer 

Product Safety Commission

Page 53 GAO-13-588 International Regulatory Cooperation

Appendix IV: Comments from the Consumer 

Product Safety Commission
Appendix IV: Comments from the Consumer

Product Safety Commission

Page 54 GAO-13-588 International Regulatory Cooperation
Appendix V: GAO Contact and Staff 

Acknowledgment

Page 55 GAO-13-588 International Regulatory Cooperation

Michelle Sager, (202) 512-6806 or sagerm@gao.gov

In addition to the contact named above, Tim Bober (Assistant Director), 

Claude Adrien, Melissa Emrey-Arras, Lynn Cothern, Kim Frankena, 

Joseph Fread, Debra Johnson, Barbara Lancaster, Andrea Levine, Grace 

Lui, Susan Offutt, and Cynthia Saunders made key contributions to this 

report.

Appendix V: GAO Contact and Staff 

Acknowledgment 

GAO Contact 

Acknowledgments 

(450962)
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