Action Plan for Import Safety

A roadmap for continual improvement 

Report to the President 

Interagency Working Group on Import Safety 

November 2007 
Interagency Working Group on 

Import Safety: 

Department of Health and 

Human Services 

Department of State 

Department of Treasury 

Department of Justice 

Department of Agriculture 

Department of Commerce 

Department of Transportation 

Department of Homeland 

Security 

Office of Management and 

Budget 

United States Trade 

Representative 

Environmental Protection 

Agency 

Consumer Product Safety 

Commission 

We will continually improve the safety of 

imported products in a manner that expands 

global trade and protects the health and safety of 

every American. 

President George W. Bush 

Interagency Working Group on 

Import Safety: 

Department of Health and 

Human Services 

Department of State 

Department of Treasury 

Department of Justice 

Department of Agriculture 

Department of Commerce 

Department of Transportation 

Department of Homeland 

Security 

Office of Management and 

Budget 

United States Trade 

Representative 

Environmental Protection 

Agency 

Consumer Product Safety 

Commission 
ovember 6, 2007 

he President 

he White House 

ashington, D.C. 20500 

ear Mr. President: 

king Group on Import Safety is pleased to submit this Action Plan 

fety: A roadmap for continual improvement. In it, we detail a roadmap 

g-term recommendations and action steps. 

ination of thousands of hours of research and 

 hundreds of stakeholders. The 

akes the form of 14 broad recommendations and 50 specific action steps 

ial 

unicate our import safety priorities 

e partners around the world. The Office of the United States Trade 

rette 

ported to the United States. 

N

T

T

W

D

The Interagency Wor

for Import Sa

with short- and lon

This Action Plan represents the culm

analysis, as well as public comment received from

Action Plan t

based on Protecting the American Consumer Every Step of the Way: A strategic 

framework for import safety and the Immediate Actions Memorandum presented to you 

on September 10, 2007. 

In the last two months, significant progress has been made on the Immediate Action 

Items listed in my memorandum to you accompanying the Strategic Framework. The 

Office of Management and Budget has actively engaged the departments, and all 

agencies are on track to accelerate their participation in the Automated Commerc

Environment / International Trade Data System. In addition, the State Department has 

led a vigorous international outreach effort to comm

with our trad

Representative has moved forward with the departments and agencies to explore 

existing import safety-related agreements with foreign governments and to coordinate 

future agreements to benefit the United States and not merely individual agencies. 

 

A variety of actions and plans are already underway to improve import safety. Today, 

the Food and Drug Administration is releasing a new Food Protection Plan. In 

September, the Consumer Product Safety Commission signed a renewed agreement 

with the People’s Republic of China focused on the safety of toys, fireworks, ciga

lighters and other targeted products. These steps, and other recent actions and current 

plans, have jump-started our efforts to continually improve the safety of products 

im
f 

d 

nalyzed for this Action Plan reaffirms the essential and 

tegrated import-safety roles of the public and private-sector. Our recommendations 

n 

ommunity. 

 safe marketplace. 

he 

erve this great country. 

ecretary, Health and Human Services and 

hair, Interagency Working Group on Import Safety

Each recommendation in this Action Plan falls under the organizing principles o

prevention, intervention and response and expands upon the building blocks identifie

in the Strategic Framework. Together, the Strategic Framework and this Action Plan 

provide a national strategy for continually improving the safety of imported products. 

The information collected and a

in

pertain to all parties involved in the import life cycle, from production in the foreig

country through U.S. ports-of-entry to final consumption or use by American 

consumers. The public and private-sectors have a shared interest in import safety and 

substantive improvement will require the careful collaboration of the entire importing 

c

This Action Plan provides a roadmap that ensures the benefits of the global economy 

and improves the safety of imported products. Progress will require that we work 

collaboratively, partner with the importing community and state and local 

governments, and reach out to foreign producers, exporters and governments. By 

doing so, all involved will be more prosperous and will continue to benefit from an 

abundant and

We recommend that Working Group designees meet within 30 days to assess progress

in implementation of this Action Plan, and to discuss how best to collaborate with t

private-sector to continue effective implementation. 

On behalf of the members of the Interagency Working Group on Import Safety, we 

thank you for the opportunity to s

Respectfully, 

[Signed] 

Michael O. Leavitt 

S

C
Table of Contents

I. Introduction.................................................................2

II. Background.................................................................5 

A. Summary of Strategic Framework

B. Select Summary of Actions and Current Plans 

III. Recommendations ........................................................12 

A. Prevention with Verification.......................................18 

1. Safety Standards 

2. Certification 

3. Good Importer Practices 

4. Penalties 

5. Foreign Collaboration and Capacity Building 

B. Intervention............................................................37 

 6. Common Mission 

 7. Interoperability 

 8. Information Gathering 

 9. New Science 

10. Intellectual Property Protection 

C. Response...............................................................51 

11. Recall 

12. Federal-State Rapid Response 

13. Technology 

14. Track-and-Trace 

IV. Conclusion.................................................................57

V. Appendices................................................................59

A. Executive Order 13439: Establishing an Interagency Working 

Group on Import Safety (July 18, 2007) 

B. Immediate Actions Memorandum (September 10, 2007) 

C. Recent Actions and Current Plans to Protect American 

Consumers 

D. List of Acronyms and Abbreviations 

E. Import Safety Working Group Designees and Staff
Action Plan for Import Safety: A roadmap for continual improvement 

www.importsafety.gov 

Introduction 

On September 10, 2007, the Interagency Working Group on Import Safety1

(Working Group) presented a Strategic Framework (Strategic Framework) and 

Immediate Actions2

 for continual improvement in import safety.3 The Strategic 

Framework provides the foundation for this Action Plan for Import Safety. 

Together, the Strategic Framework, Immediate Actions and this Action Plan 

fulfill the requirements of Executive Order 13439, which established an 

Interagency Working Group on Import Safety and was signed by President 

Bush on July 18, 0 20 7. 

A careful examination of import safety has been motivated by the recent 

challenges presented by an increasingly global economy, in which U.S. 

consumers are purchasing approximately $2 trillion worth of products that are 

imported by over 800,000 importers through over 300 ports-of-entry. 

In developing the Strategic Framework, Immediate Actions and Action Plan, the 

Working Group engaged in a campaign to solicit comments and 

recommendations from the public. Since the release of the Framework, the 

Working Group has received information and comments from hundreds of 

stakeholders. Health and Human Services Secretary Leavitt and other Cabinet 

mem s tr ber aveled throughout the United States and other countries to discuss 

imp safe

 

ort- ty issues. They met with federal, state and local officials, producers,

 1 The Working Group includes the Secretaries of the Department of Health and Human 

Services, the Department of State, the Department of the Treasury; the Attorney General; the 

Secretaries of the Department of Agriculture, the Department of Commerce, the Department of 

Transportation and the Department of Homeland Security; the Director of the Office of 

Management and Budget; the United States Trade Representative; the Administrator of the 

Environmental Protection Agency; and the Chairman of the Consumer Product Safety 

Commission. The Food and Drug Administration, Customs and Border Protection and the Food

Safety and Inspection Service were active participants on the Working Group as well. 2

 See Appendix B for the September 10, 2007 Memorandum to the President that included these

Immediate Actions. 

3

 See Protecting the American Consumer Every Step of the Way: A strategic framework for 

import safety. 

2
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3

importers, distributors and retailers. In addition, they held roundtable 

discussions and media events to engage the public and importing community4 in 

the activities of the Working Group. 

The Working Group also met with Members of Congress and representatives of 

foreign governments to solicit comments and recommendations. The Working 

Group issued a Federal Register notice requesting written comment and 

announcing a public meeting, which was held in Washington, D.C., on October 

1, 2007. Representatives from the 12 Cabinet departments and agencies 

comprising the Working Group listened to comments and recommendations 

from the importing community and the public on import safety. 

Officials from each member department met with scores of their private-sector 

constituencies to discuss import-safety issues. Texas A&M University 

convened a Conference on Import Safety Science and Technology on October 

18, 2007. Additionally, the Working Group created an import-safety Web site, 

and utilized novel approaches such as webinars to provide information and to 

solicit comments and views from the importing community and the public. 

The oral comments from the public meeting and the written comments 

submitted, as well as the input received by the member departments from the 

public, provided significant input that was used in the development of the 

recommendations in this Action Plan. 

The seminal finding of the Framework was that, to adapt to a rapidly growing 

and changing global economy, the U.S. government must develop new importsafety strategies that expand and emphasize a cost-effective, risk-based 

approach. Such an approach identifies risks at the points they are most likely to 

4 The term “importing community” is used broadly throughout this document to include all 

domestic entities in the supply chain. 
Action Plan for Import Safety: A roadmap for continual improvement 

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occur, and then targets the response to minimize the likelihood that unsafe 

products reach U.S. consumers. 

This Action Plan presents broad recommendations and specific short- and longterm action steps under the organizing principles of prevention, intervention and 

response. Each action item is based on the building blocks identified in the 

Strategic Framework, released in September 2007. The Strategic Framework 

and this Action Plan provide a national strategy for continually improving the 

safety of imported products. 

Implementation of this Action Plan will require expanded legal authorities, 

improved collaboration and capacity building with our trading partners, 

improved collaboration with state and local governments and the private-sector, 

increased information gathering and the discovery and application of new 

science. Implementation of the recommendations will require resources, 

including reallocation of existing resources, as well as trade-offs, to fund these 

priorities. 

The Working Group recommends that representatives of the member 

departments and agencies meet within 30 days to assess progress in 

implementation of the Action Plan and to discuss possible mechanisms for 

collaboration with the private-sector to continue the effective implementation of 

this Action Plan. 

4
Action Plan for Import Safety: A roadmap for continual improvement 

Background 

www.importsafety.gov 

his Action Plan builds on the earlier companion report: Protecting American 

to 

 risk of the product is greatest, and then verifies 

e safety of products at those important points. 

gic 

, 

n and 6) Promote Technological Innovation and New Science. 

ublic comments on the Strategic Framework show widespread acceptance and 

T

Consumers Every Step of the Way: A strategic framework for continual 

improvement in import safety (Strategic Framework). That report concluded 

that the United States must transition from an outdated “snapshot” approach 

import safety, in which decisions are made at the border, to a cost-effective, 

prevention-focused “video” model that identifies and targets critical points in 

the import life cycle where the

th

This Action Plan follows the organizing principles identified in the Strate

Framework – prevention, intervention, and response – and draws on six 

building blocks: 1) Advance a Common Vision; 2) Increase Accountability

Enforcement and Deterrence; 3) Focus on Risks Over the Life Cycle of an 

Imported Product; 4) Build Interoperable Systems; 5) Foster a Culture of 

Collaboratio

P

support of the organizing principles and building blocks. 

The following is a brief summary of the Strategic Framework that forms the 

foundation of this Action Plan. Readers familiar with the Framework are 

encouraged to proceed to the Recommendations section. 

5
Action Plan for Import Safety: A roadmap for continual improvement 

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cation 

 Plan: 

ks 

Summary of the Strategic Framework 

The Strategic Framework advocates a strategy that shifts the primary emphasis 

for import safety from intervention to a risk-based prevention with verifi

model. It recommends that the public and private-sectors work together to 

identify risks and consider new approaches for addressing these risks. The 

vision of the Strategic Framework is to improve continuously the safety of 

imported products. 

Three organizing principles form the keystones of the Strategic Framework and

the recommendations included within this Action

1. Prevention – Prevent harm in the first place. 

The U.S. government must work with the private-sector and foreign 

governments to adopt an approach to import safety that builds safety into

manufacturing and distribution processes. This effort will reduce the ris

to consumers from otherwise dangerous imported products. 

2. Intervention – Intervene when risks are identified. 

Federal, state, local and foreign governments, along with foreign producers 

and the importing community, must adopt more effective techniques for 

identifying potential product hazards. When problems are discovered, 

government officials must act swiftly, and in a coordinated manner, to seize, 

destroy or otherwise prevent dangerous goods from advancing beyond the 

point-of-entry. For foreign countries, taking steps to ensure the safety of 

products exported to the United States will benefit them by facilitating trade. 

3. Response – Respond rapidly after harm has occurred. 

In the event that an unsafe import makes its way into domestic commerce, 

swift actions must be taken to limit potential exposure and harm to the 

American public. 

6
Action Plan for Import Safety: A roadmap for continual improvement 

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ent 

nts 

g together with shared objectives. Revised measures 

Within each of these organizing principles are the cross-cutting building blocks 

identified in the Strategic Framework that departments and agencies should use 

to guide their programs. 

Building Block 1: Advance a Common Vision 

There should be a shared vision and shared goals across the federal governm

for promoting import safety. Relevant policies and procedures should be 

reviewed and, where appropriate, revised to ensure that all federal departme

and agencies are workin

should encourage public and private parties involved in the import life cycle to 

adopt this common vision. 

Building Block 2: Increase Accountability, Enforcement and Deterrence 

While it is important to remember that industry has a financial interest to sell 

safe products to its consumers, all actors involved in the production, distribution 

and sale of imports must be held accountable for meeting their obligations to 

ensure that imported products meet safety standards5

 in the United States. The 

federal government will continue to work with industry to foster compliance 

with these standards, but is also prepared to use appropriate criminal and civil 

enforcement tools to hold companies and individuals accountable and to protect 

consumers. 

Building Block 3: Focus on Risks Over the Life Cycle of an Imported 

Product 

In addition to identifying unsafe products at the border, the new approach must 

focus on the most important safety considerations affecting imported goods 

throughout their import life cycle – from overseas production to U.S. ports-of5 “Safety standards” may have a different meaning in different contexts. In this case, we are 

using the term in a broad sense to refer to recognized standards in the United States that ensure 

products, including chemical substances and pesticides, are safe for people and animals. By 

“recognized standards” we are referring to those standards for which compliance is required by 

United States law or regulation, or for which compliance is voluntary but, if met, is considered 

by the federal agency with jurisdiction as sufficient to meet federal requirements. These 

standards can be national or international.

7
Action Plan for Import Safety: A roadmap for continual improvement 

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s 

of minimizing risks and maximizing quality in 

w environment for the collection of information and will improve 

cies 

port community.

entry, through final consumption or use in the United States. A key element is 

developing the ability to identify and manage risk at critical points along the 

import life cycle. Rather than the primary line of defense, intervention at the 

border must become one part of a network of interconnected measures that 

protect the American public and facilitate the entry of safe imports that comply 

with U.S. statutes and regulations. 

The federal government should move to a more risk-based, cost-effective 

approach to identify and mitigate risks posed by imported products. Principle

of hazard analysis and risk management have long been applied in 

manufacturing as a method 

production processes. These principles enable the targeting of resources to 

areas of greatest risk. 

Building Block 4: Build Interoperable Systems 

The federal government needs to finalize implementation of interoperable data

systems already under development that facilitate the exchange of relevant 

product information among parties within the import supply chain to ensure 

import safety. The International Trade Data System (ITDS) initiative is a key 

component to improve systems interoperability. The ITDS initiative will create 

a single-windo

and enhance information sharing among government departments and agen

and the im

Building Block 5: Foster a Culture of Collaboration 

The federal government must develop a culture of collaboration that will 

permeate relationships among federal departments and agencies and their 

external stakeholders. All parties (federal, state, and local governments, foreign 

governments, foreign producers, foreign exporters and the importing 

community) involved in the import life cycle need to work together to prevent 

unsafe products from entering the United States and to take swift and effective 

action if such products do enter domestic commerce. This collaboration must 

8
Action Plan for Import Safety: A roadmap for continual improvement 

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build on international multilateral and bilateral agreements to ensure the safety 

of products imported into the United States without creating unjustified trade 

barriers. As some unsafe products result from violations of patents and 

trademarks, the federal government will also work to increase coordination with 

U.S. industry to enforce intellectual property rights (IPR) and prevent the entry 

of counterfeit and potentially unsafe products into supply and distribution 

chains. This will require a new era of collaboration, as the federal government 

works to identify better ways to engage all parties in the import life cycle. 

Building Block 6: Promote Technological Innovation and New Science 

A more effective and efficient import-safety system will depend on the 

development and application of new science and technology. Implementation 

of innovative technologies will afford the opportunity to screen larger volumes 

of imported products at points-of-entry. These screening procedures will help 

evaluate and target high-risk commodities, increasing analytical efficiency and 

the number of imported products tested. Research into the causes of risk, such 

as the conditions that lead to contamination of foods with certain pathogens, can 

help government and industry identify vulnerable points in the import life cycle 

for specific products. 

These building blocks and the organizing principles provide the foundation for 

the recommendations that follow. 

9
Action Plan for Import Safety: A roadmap for continual improvement 

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Action Plan for Import Safety: A roadmap for continual improvement 

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Select Summary of Actions and Current Plans to Protect American Consumers 

As directed by the President, all departments and agencies have been reviewing and assessing current procedures, authorities, outreach 

efforts and international cooperation initiatives to enhance the safety of imported products. Based on these reviews and meetings, the 

departments and agencies have already taken numerous actions to protect American consumers. Many more initiatives to enhance the saf

of imported products are underway and will be completed in the coming months. Here is a sample of significant recent accomplishments 

and important actions that will be completed within the first 200 days of issuing this Action Plan. A more complete list is shown in 

Appendix C: Recent Actions and Current Plans to Protect American Consumers.

ety 

Safety Standards 

• Food Protection Plan. The Food and Drug Administration (FDA) has developed a Food Protection Plan that addresses both 

food safety and food defense for domestic and imported products, including food protection from production to consumption. 

The Plan will be phased in over the coming months and is integrated with the Administration’s Import Safety Strategic 

Framework and Action Plan. 

Certification 

• Seafood Inspection Program. As of October 24, 2007, the Department of Commerce’s National Oceanic and Atmospheric 

Administration (NOAA) Seafood Inspection Program had inspected and certified seven seafood processing plants in China and 

had plans to inspect another 12 plants. There are a number of other plants scheduled to be inspected. 

• Seafood Inspectors Stationed in Other Asian Countries. NOAA is in the process of stationing an inspector full time in Hong 

Kong, and has plans to put inspectors in other countries that export large volumes of seafood to the United States. 

Foreign Cooperation and Capacity Building 

• Safety Agreement with China on Toys, Fireworks, Electrical Products. Meetings held in September 2007 between the 

Consumer Products Safety Commission (CPSC) and its counterpart, the General Administration of Quality Supervision, 

Inspection, and Quarantine (AQSIQ) of the People’s Republic of China, resulted in a renewed Memorandum of Understanding

(MOU) related to the promotion of safety for target products – children’s toys, fireworks, cigarette lighters, and electrical 

products. 

• Security and Prosperity Partnership (SPP) priority on Safe Food and Products. In August, President Bush, President 

Calderon of Mexico and Prime Minister Harper of Canada pledged to strengthen trilateral cooperation and mechanisms within 

the region, build on current standards and practices and work with our trading partners outside of North America to identify and 

stop unsafe food and products before they enter our countries. 

• Memoranda of Agreements with China on Food, Drugs, Medical Devices and Animal Feed. HHS/FDA is negotiating 

binding agreements with the Chinese government to enhance regulatory cooperation in the area of drugs, medical devices, food, 

and animal feed. These agreements will protect the safety and health of consumers and animals in the United States and in 

China. 

• Motor Vehicle Safety Agreement with China. On September 12, the Department of Transportation’s National Highway 

Traffic Safety Administration (NHTSA) signed a Memorandum of Cooperation with China aimed at increasing cooperation in 

the areas of motor vehicle regulation and safety. Both sides indicated a willingness to work together to address issues related to 

the safety of Chinese motor vehicles and equipment (including tires and automotive fuses) intended for export to the United 

States. 

• Foreign Training on United States Safety Standards for Meat, Poultry and Eggs. In July 2007, United States Department of 

Agriculture (USDA) and FDA conducted a seven-week training program for Chinese inspection officials. Food Safety and 

Inspection Service (FSIS) also conducted outreach to foreign government inspection officials regarding FSIS import 

requirements for meat, poultry and egg products. FSIS provided technical assistance to the Austrian government regarding U.S. 

import requirements for ready-to-eat products, to Mexico regarding microbiological testing procedures and to the governments of

Bosnia-Herzegovina, Namibia and Thailand about U.S. import requirements in general. 

Response 

• Marking Rule to Prevent Port-Shopping. By mid-2008, FDA will issue a proposed rule that would require imported food that 

has been refused entry to be marked “United States: Refused Entry”. Such marking would help prevent the introduction of 

unsafe food into the United States through port shopping, a practice whereby importers attempt to gain entry through a port after 

the goods have been refused at another. 

11
Action Plan for Import Safety: A roadmap for continual improvement 

Recommendations 

T

www.importsafety.gov 

ect and evaluate pertinent 

ation for all commercial cargo before it reaches the United States. Under 

ion, cargo that does not meet the expectations, contractual requirements or 

e, risk-based approaches across the 

ntion and response. Together, the organizing principles, 

he current import-safety system in the United States has served the public well 

or many years and is among the most effective in the world. In this system, the 

ublic and private-sectors work collaboratively to coll

f

p

inform

U.S. law, cargo that does not meet federal government requirements, including 

those relating to safety, is not allowed to enter domestic commerce. In a similar 

fash

safety standards of the private-sector jeopardizes trading relationships and 

compromises business. These legal requirements and market-based measures 

work together to protect the American public. 

The recommendations included in this Action Plan build upon the current 

import-safety system and activities already being undertaken by the public and 

private-sectors by focusing on cost-effectiv

entire import life cycle. The Working Group presents 14 broad 

recommendations and 50 action steps, each with a lead entity and time frame. 

The recommendations include short- and long-term action steps that should 

commence immediately.6

 

The recommendations are categorized in this Action Plan based on the 

organizing principles outlined in the Strategic Framework – prevention, 

interve

recommendations and action steps create an import-safety roadmap to promote 

continual improvements in import safety. 

6

 “Short term” refers to those action steps that can be completed within the next 12 months; 

“long term” refers to those action steps that will take longer to complete. 

12
Action Plan for Import Safety: A roadmap for continual improvement 

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13
Action Plan for Import Safety: A roadmap for continual improvement 

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14

Points of Clarification 

Before presenting the recommendations and action steps, several clarifications 

are helpful: 

• Shared interest – The information collected and analyzed for this 

Action Plan reaffirms the key and integrated import-safety roles of

public- and private-sector actors. Both have a shared interest in the 

safety of imported products and both must continue working together to 

protect the American consumer. The import-safety chain stretches from 

the point of foreign origin, both of materials and finished product, to 

domestic consumption or use. All entities involved in the import life 

cycle – foreign producers (growers and manufacturers), governments, 

distributors, exporters, U.S. importers, distributors, manufacturers and 

retailers, testing and certification bodies and regulatory authorities at the 

federal, state and local levels – must work together to prevent unsafe 

products from entering the United States. The appropriate entities in the 

supply chain must also take swift and effective action when harmful 

products do enter domestic commerce. 

• Private-sector interest and mechanisms – The private-sector not only 

has a significant interest in ensuring safety, but also has a wide array of 

mechanisms to support federal objectives. Likewise, the federal 

government can learn and benefit from the experience of the privatesector. Although the action steps in this Action Plan pertain primarily to 

the federal government, the Action Plan recognizes the importance of 

private-sector mechanisms and experience and lays a foundation for 

ongoing, substantive public/private collaboration.

• Consumer interest – The Action Plan recognizes that consumers have a 

vital interest in the safety of imported products and anticipates active 
Action Plan for Import Safety: A roadmap for continual improvement 

www.importsafety.gov 

ent in the implementation of the recommendations 

at 

as 

ls, 

t 

n 

-effective, risk-based approach. 

consumer engagem

and action steps.

• Risk-based strategies – This Action Plan is built on the concept th

focusing on risk is the most effective way to address safety over the

broad spectrum of products imported by the United States. Some are

and products need more attention than others because of the potential 

risks they could present and because of differences in the product and 

the production environment. These differences include process contro

the history of compliance, the intended use of the product, the inheren

risks of the product and other factors demonstrated by science and 

experience to be valid predictors of risk to the public. The federal 

government must continue to make choices about where it focuses its 

resources, and basing those choices on risk means that better and more

logical decisions will be made with more effective results. Therefore, 

there is no one-size-fits-all solution. The recommendations and actio

steps in this Action Plan reflect this cost

• Accountability – The Strategic Framework stresses that import safety 

can be advanced through shared efforts and shared responsibility 

throughout the entire import life cycle, from foreign governments, 

producers, distributors and exporters to U.S. importers, producers, 

distributors and retailers, as well as the federal and state governments. 

Any private entity that seeks to benefit from access to the U.S. market 

has the same responsibility domestic producers have to ensure their 

products meet all applicable U.S. safety standards. For example, 

producers of drugs and medical devices are expected to meet the 

standards set by the FDA. Steps to create incentives for foreign firms to 

ensure this outcome are an important part of the Action Plan. In 

addition, the U.S. importing community, either as a link in the U.S. 

15
Action Plan for Import Safety: A roadmap for continual improvement 

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distribution chain or as the seller to the ultimate consumer, must share 

the commitment to ensure that products brought into the United States 

are manufactured in accordance with U.S. safety standards. 

All entities involved in the import life cycle are responsible for ensuring 

the safety of the products they produce, distribute, export, import or sell. 

The specific responsibilities of each entity depend on the activities in 

which they engage. For example, producers are responsible for making 

products that comply with U.S. safety standards. Importers are 

responsible for bringing products that meet U.S. safety standards into 

this country in a manner that does not compromise the safety and, where 

appropriate, efficacy of the product. 

• Resources – To implement the Action Plan to its fullest extent will 

require resources. Federal departments and agencies will coordinate, 

plan effectively and meet these goals by submitting additional funding 

needs through the normal budget process. 

• Common mission, varying statutory roles – While the entire federal 

government is responsible for advancing import safety, each department 

and agency operates within a unique statutory framework. The 

recommended actions do not apply uniformly to all federal entities. 

Instead they are tailored to product risk and the relevant statutory 

frameworks serve as tools to improve the safety of imported products on 

an ongoing basis. Where appropriate, the action steps identify affected 

departments and agencies. 

16
Action Plan for Import Safety: A roadmap for continual improvement 

Facilitate Trade but Target High-Risk

Imports 

The recommendations in this Action Plan are 

designed to promote import safety while 

avoiding restrictions on the flow of international 

trade. Some recommendations provide incentives 

to foreign producers, suppliers and importers that 

will expedite the entry of products that meet 

United States standards. Others lead to greater 

information about these entities. These 

incentives and the collection of better 

information will enhance the capacity of the 

federal government to focus on those products 

that may present a risk to consumers in the 

United States. By improving the management of 

risk, we can facilitate the trade of safe products 

and devote more personnel and resources to 

high-risk products and products of unknown risk. 

Complementary Findings – The recommendations and action steps 

outlined in this Action Plan take into

consideration the wide array of other 

planned or ongoing actions by the 

federal government and other entities 

to improve the safety of imported 

products. The findings of this Action 

Plan are additive and complement 

other meaningful changes and 

programs. Appendix C includes a 

summary description of recent 

activities and current plans that 

expand upon and complement this 

Action Plan. 

•

Implementation 

Effective implementation will require the concerted effort of all participants in 

the import life cycle, creating an expanded culture of collaboration. The federal 

government must lead by example to build each of these recommendations into 

agency priorities and budgets. To aid in this process and ensure accountability, 

each action step has a designated lead agency or agencies. 

www.importsafety.gov 

17
Action Plan for Import Safety: A roadmap for continual improvement 

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Safety and Security 

Since the United States government bases its 

decisions about whether or not a product may 

enter the country on both safety and security 

considerations, certification programs 

referenced in the action steps would assess 

compliance with both safety and security 

standards. In today’s world, certification for 

import safety and certification for import 

security need to be closely coordinated. 

Consideration should be given to merging 

these two certification processes into one 

program. 

Prevention with Verification 

This Action Plan recommends using market-based and regulatory incentives 

and deterrents to encourage foreign entities to build safety into products 

destined for the American market and to encourage domestic entities to ensure 

that the products they import meet safety standards in the United States. This 

approach holds all participants in the import life cycle, both foreign and 

domestic, accountable for ensuring the safety of imported products by using a 

cost-effective, risk-based strategy. It includes: 

• Creation of mandatory and voluntary third-party certification programs 

for foreign producers that are based on product risk, to verify 

compliance with U.S. safety standards; 

• Development of good importer practices; and 

• Use of strong penalties against bad actors. 

Based on their risk, many products may not 

warrant the establishment of a mandatory or 

voluntary certification program. The federal 

government will also work with its trading 

partners to promote, where needed, the 

development of the regulatory capacity and 

legal systems necessary to ensure the safety of 

the products they export to the United States. 

The following recommendations, action steps, lead entities and time frames 

present a detailed roadmap for further action. 

18
Action Plan for Import Safety: A roadmap for continual improvement 

Safety Standards 

www.importsafety.gov 

ported 

elopment organizations and 

ety standards, where needed 

ention 

d 

oration of science-based safety 

stand s

assessme

Indus 

based e or assuring product 

fety. The federal departments and agencies with jurisdiction over im

s dev

. saf

crease 

flect, to the extent possible, the same level of protection maintained in the 

consider the best available 

ience, industry best practices and standards set by credible national and 

ternational standards development organizations. 

Recommendation 1 – Create New and Strengthen Existing Safety Standards 

An organizing principle of the Strategic Framework is the concept of prev

with verification. This concept is predicated on a philosophy of building 

assurances of safety into production processes and establishing appropriate 

supply-chain controls, rather than relying solely on physical inspection an

testing of products at ports-of-entry to identify and mitigate safety hazards. 

Prevention with verification embraces the incorp

ard into production and distribution systems, combined with compliance 

nts to ensure these standards are being met.

try best practices have long reflected a commitment to the use of risk-

 pr ventive controls as an effective mechanism f

sa

products should work with industry, standard

other members of the public to strengthen U.S

and appropriate, particularly for products 

determined to be high-risk. Federal 

departments and agencies should also in

their participation in international standardssetting organizations to encourage the 

development of international standards that 

re

United States. When adopting or developing safety standards, the federal 

department or agency with jurisdiction should 

sc

in

19

The federal departments and agencies with 

jurisdiction over imported products should 

work with regulated industry and other 

members of the public to strengthen United 

States safety standards, where needed and 

appropriate, particularly for products 

determined to be high-risk. 
Action Plan for Import Safety: A roadmap for continual improvement 

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Apply the Same Safety Standards to Domestic 

and Foreign Made Products

ers should be 

de in the United 

endations are aimed 

s, exporters and 

 held 

ame product 

ributors in the 

tional trade 

new safety

availa

will n

du

nd mandatory manufacturer/importer certification 

s 

ose 

o 

supplier compliance with 

 issue a fal

ent. As a benefit to inspecting 

by 

 Lead: CPSC 

 Time Frame: Short Term 

1.1 Exte

requirement under section 14 of the Consumer Product Safety 

Act (CPSA) to all statutes administered by Consumer Product 

Safety Commission (CPSC). All mandatory safety standard

promulgated by the CPSC under the CPSA require a 

manufacturer’s or importer’s certification of conformity to th

standards. The other key statutes administered by the CPSC d

not contain similar certification provisions for mandatory safety 

standards. In the CPSC’s experience, requiring the certification 

of conformity improves 

A product sold to American consum

safe regardless of whether it is ma

States or abroad. These recomm

at ensuring that foreign producer

distributors, as well as importers, are

accountable for compliance with the s

safety standards as producers and dist

United States. Consistent with interna

rules and longstanding United States practice, any

pro

mandatory standards. 

The requirement 

simplifies and 

strengthens enforcement 

at ports because products 

that are not accompanied 

by a declaration of 

conformity must be 

refused entry. Also, 

because it is unlawful to

easily circumvent the requirem

officials, the process of checking for a certificate is not 

burdensome and does not require any additional government 

testing or evaluation. Extending the existing conformity 

requirement under the CPSA to other statutes administered 

the CPSC would enhance its ability to ensure product safety. 

 rules will be transparent, will be based on 

ble scientific and technical information and 

ot discriminate unfairly against imported 

cts over domestic products. 

se declaration, firms cannot 

20
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21

1.2. Clarify the Food and Drug Administration’s (FDA) authority to 

require preventive controls for certain foods. This action step 

would strengthen FDA’s ability to require, by regulation, 

preventive control measures to address risks that might occur for 

domestic and foreign produced foods associated with repeated 

serious adverse health consequences or death from unintentional 

contamination. FDA would take into consideration industry best 

practices, such as Hazard Analysis and Critical Control Points 

(HACCP) requirements.

 Lead: HHS / FDA 

 Time Frame: Short Term 

1.3 Provide the FDA with authority to require measures to prevent 

the intentional contamination of domestic and foreign foods. 

The FDA would use this authority to issue regulations to require 

companies to implement practical food defense measures at 

specific points in the food supply chain where the potential for 

intentional adulteration resulting in serious adverse health 

consequences or death to humans or animals is the greatest. This 

authority would apply to food in bulk or batch form, prior to 

being packaged.

 Lead: HHS / FDA 

Time Frame: Short Term 

1.4 Examine food-safety control systems of other countries to 

determine whether improvements can be made to the operation 

of FDA’s food regulatory program. The examination would 

provide FDA with comprehensive knowledge of food safety 

systems of other countries. FDA could identify elements or 

components of those systems that are recognized as food safety 
Action Plan for Import Safety: A roadmap for continual improvement 

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system “best practices” and utilize them to strengthen and 

enhance FDA’s prevention, intervention and response activities.

 Lead: HHS / FDA 

 Time Frame: Long Term 

1.5 Expand the use of public-private-sector standards programs. 

Standards programs established and administered by the privatesector with input from government can provide a generally 

accepted forum for developing safety standards. Organizations 

such as the International Organization for Standardization and 

U.S.-based international standards developers accredited by the 

American National Standards Institute devise standards that the 

federal government may subsequently recognize. Greater use of 

these venues can accelerate the development of needed safety 

standards. They should be pursued, as appropriate, as long as the 

standards developed are based on sound scientific information 

and utilized domestically. 

 Lead: Department of Commerce 

 Time Frame: Long Term 

Certification 

Recommendation 2 – Verify Compliance of Foreign Producers with United 

States Safety and Security Standards Through Certification 

Import certification can augment federal department and agency resources, 

facilitate trade by expediting the entry of products from certified firms, and 

assist the importing community in implementing effective Good Importer 

Practices. As appropriate, certification would include periodic on-site 

inspections and random testing. Certification would need to be renewed 

periodically at intervals that could vary based on product risk, such as with 

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greater frequency for high-risk goods. This Action Plan contemplates the use of 

both mandatory and voluntary certification. 

The Action Plan recommends tailoring import certifications to both the 

product’s level of risk and its intended use. Currently, federal departments and 

agencies use import certifications in a variety of contexts. For example, as a 

condition for export of meat, poultry and egg products to the United States, the 

Food Safety and Inspection Service (FSIS) certifies foreign countries that, in 

turn, certify producers that meet U.S. requirements. Such certification ensures 

that the products comply with U.S. requirements. While requiring import 

certifications for all goods is not necessary, in certain circumstances (e.g., highrisk products), this extra step may be warranted. Therefore, the Action Plan 

recommends mandatory certification for select high-risk products. 

The Action Plan also recommends expanded use of voluntary import 

certifications for other products. To encourage and assist foreign producers to 

meet U.S. standards, the federal government should establish voluntary 

certification programs as appropriate. Voluntary certification programs may 

provide importers with important compliance information and help them ensure 

that the products they import meet U.S. standards. If widely used, these 

programs will also assist the federal government in properly targeting inspection 

resources to those products of greatest risk. For this reason, we propose 

incentives to motivate voluntary participation. For example, products made by

certified firms would generally receive expedited processing at U.S. ports-ofentry. Furthermore, the federal government will ensure that information about 

certified firms and importers of record is easily accessible to the public. 

Mandatory Certification

Mandatory certification may be necessary to ensure that imported products are 

safe in certain circumstances. This would involve safety considerations, 

including risks associated with the product itself or its place of origin. 

23
Action Plan for Import Safety: A roadmap for continual improvement 

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 resources to 

uld be 

h 

 that 

litate 

ral departments and agencies to focus their resources 

s and 

Generally, in such cases, the only other option available is to deny the entry of 

these products into the United States. By requiring that such products be 

certified, or produced by a certified firm in order to be imported, a mechanism 

will need to be provided that allows trade to continue flowing while also 

enhancing safety. 

2.1 Provide the FDA with the authority to require a certification or 

other assurance that a product under its jurisdiction complies 

with FDA requirements. Certification would be mandated based

on risk and generally would apply to products coming from a 

particular country, region, or producer where safety cannot be 

adequately ensured for these products in the absence of such 

assurance. This would allow the FDA to redirect its

other products. Such import certification programs wo

used for designated products imported from countries with whic

FDA has an agreement to establish a certification program

provides a level of safety sufficient to meet HHS/ FDA 

standards. FDA would accept certifications from either relevant 

government agencies or accredited third parties.

 Lead: HHS / FDA 

 Time Frame: Short Term 

Voluntary Certification 

For foreign producers, the ability to participate in voluntary certification 

programs could allow products from firms that comply with U.S. safety and 

security standards to enter the United States more quickly. This would faci

trade, while allowing fede

on products from non-certified firms or for which information suggests there 

may be safety or security concerns. This would allow federal department

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Action Plan for Import Safety: A roadmap for continual improvement 

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In September 2007, the U.S. Toy Industry 

of America (TIA) announced plans to 

implement new compliance systems to 

bolster the safety of toys sold in the United 

States. The initiative, created in 

consultation with the American National 

Standards Institute and the Consumer 

Product Safety Commission, includes the 

development of standardized testing 

procedures and laboratory certification 

criteria. 

agencies to more effectively target their resources. It may not be necessary to 

establish certification programs for low-risk products. 

2.2 Develop voluntary certification programs based on risk for 

foreign producers of certain products who export to the United 

States. The federal government will work with the importing 

community and other members of the public to develop 

voluntary certification programs, as appropriate, based on risk. 

As part of this effort, the federal 

government should take into 

consideration, incorporate or 

expand upon existing trusted 

trader partnership programs 

including CBP’s Importer Self 

Assessment Program (ISA) and 

programs that relate to security.7

Leads: CPSC, HHS / FDA, DHS / CBP 

 Time Frame: Long Term 

2.3 Provide FDA with legislative authority, to accredit independent 

third parties to evaluate compliance with FDA requirements. To 

implement the previous action step (2.2), FDA will accredit third 

party organizations, or recognize an entity that accredits third 

parties. Third party organizations could be, as appropriate, 

federal departments and agencies, state and local government 

agencies, foreign government agencies, or private entities 

without financial conflicts of interest. FDA would use 

 

7

 ISA is a voluntary program for importers who agree to monitor their own compliance in 

exchange for benefits from CBP. Its primary objective is to maintain a high level of compliance 

with United States entry requirements through a cooperative partnership and information 

exchange between the importing community and CBP. 

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Action Plan for Import Safety: A roadmap for continual improvement 

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information from these accredited third party organizations in its 

admissibility decision-making. 

 Leads: HHS / FDA 

Time Frame: Short Term 

2.4 Create incentives for foreign firms to participate in voluntary 

certification programs and for importers to purchase only from 

certified firms. The federal government should establish these 

incentives, which could include expedited entry, expedited 

processing of samples for laboratory testing, and access to CBP’s 

account manager program. Utilizing expedited entry, federal 

departments and agencies with jurisdiction typically would be 

much less likely to physically examine or otherwise delay 

products made by certified firms unless the product is examined 

for auditing purposes, there is information suggesting this 

product violated U.S. law, is considered high-risk for safety or 

security reasons, or the importer of record did not provide correct 

or complete information required by U.S. law. Should samples 

be taken for testing from a product made by a certified firm, the 

agency with jurisdiction 

could expedite processing of 

those samples. Under CBP’s 

account manager program, 

the importer of record is 

assigned a contact person 

who can answer questions 

and facilitate the resolution of problems should they arise. The 

federal government will also consider setting less stringent 

bonding requirements as an incentive to import products from 

certified firms. 

26

There are many private-sector and government 

organizations that presently certify products 

and producers as meeting established national 

or international standards or accredit certifying 

bodies. The presence of such certifying or 

accrediting organizations serves as a ready 

resource to implement new voluntary 

certification programs. 
Action Plan for Import Safety: A roadmap for continual improvement 

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27

 Leads: DHS/CBP, HHS/FDA 

 Time Frame: Long Term 

2.5 Develop a plan to ensure that information regarding certified 

firms and importers of record is easily accessible. This will help 

importers to more easily determine whether or not a foreign firm 

is certified, and help distributors and retailers to identify 

importers of record who only handle goods from certified firms. 

It will also help insurers use this information for determining risk 

when underwriting importers of record, and help consumers 

determine whether or not a foreign-made product sold under its 

own label comes from a certified firm. 

 Leads: DHS / CBP, HHS / FDA 

 Time Frame: Long Term 

Good Importer Practices 

Recommendation 3 – Promote Good Importer Practices. 

Although some members of the importing community have established and met 

their own best practices, the importing community does not have available 

Good Importer Practices focused on ensuring product safety throughout the 

supply chain. Developing such practices can assist the entire importing 

community in taking appropriate steps to ensure the safety of the products they 

bring into the United States. 

To encourage the importing community to take appropriate steps to ensure the 

products they bring into this country meet U.S. standards, the federal 

government will work with the importing community to develop Good Importer 

Practices. These practices should be developed as guidelines, be risk-based and 

provide concrete guidance to the importing community for evaluating imported 
Action Plan for Import Safety: A roadmap for continual improvement 

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products. This evaluation would be based on due diligence and preventive 

controls principles. These practices will provide a set of factors that can be 

used by the importing community to evaluate foreign suppliers and products. 

Based on this evaluation, the importing community will have greater confidence 

that the products they import will be in compliance with U.S. laws and 

regulations. For example, for products with known risks, a key precaution the 

importing community could take to ensure safety consistent with Good Importer 

Practices is to purchase, distribute and sell products made by certified 

producers. As part of this collaboration, the federal government and the 

importing community should consider whether and how to foster the 

development of voluntary third-party programs to certify importers as meeting 

Good Importer Practices. 

3.1 Develop Good Importer Practices. The federal government 

should work with the importing community and other members 

of the public to develop Good Importer Practices and issue 

guidance with respect to particular product categories. The focus 

of these practices will be to ensure that imported products meet 

U.S. safety standards, as well as to promote effective supplychain management. Development of these practices would help 

the importing community take appropriate steps to ensure the 

safety of the products they bring into the United States. 

 Leads: USDA, CPSC, HHS / FDA, DHS / CBP, Department of 

Commerce (DOC) 

 Time Frame: Long Term 

3.2 Partner with the importing community to foster the creation of 

voluntary certification programs for importers. These programs 

would be private-sector based and would serve to verify 

compliance with Good Importer Practices. The federal 

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Action Plan for Import Safety: A roadmap for continual improvement 

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government would evaluate these programs to determine whether 

they should be accredited by the federal government and whether 

certification should be required for importing certain high-risk 

products. 

 Leads: CPSC, HHS / FDA, DHS / CBP, DOC

 Time Frame: Long Term

Penalties 

Recommendation 4 – Strengthen Penalties and Take Strong Enforcement 

Actions to Ensure Accountability.

To hold both foreign and domestic entities accountable and discourage them 

from producing, distributing, exporting, importing and selling unsafe products, 

the federal government will take steps to strengthen penalties against entities 

that violate U.S. laws. Effective penalties can serve as a deterrent against 

violating U.S. requirements and will improve compliance with U.S. safety 

standards and laws. 

Rigorous enforcement of U.S. import-safety laws promotes deterrence. 

Assessing civil and criminal penalties against bad actors creates the proper 

incentives for all parties across the import life cycle to behave lawfully and 

responsibly and to build safety into their products to prevent harm to 

consumers. For enforcement to be an effective tool in the promotion of import 

safety, however, civil penalties must amount to more than a business expense 

and, for the worst offenders, criminal penalties should apply. Where penalties 

are weak or lacking, enforcement measures must be strengthened to reflect a 

meaningful expectation of accountability. 

Bonds serve as a guarantee of payment for specific types of penalties levied 

against the importer. Minimum bond amounts have not changed since 1991 and 

do not reflect the likelihood that a product may not meet U.S. importing or 

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safety requirements. Compliance with U.S. safety requirements can be 

encouraged by raising the minimum bond amounts and increasing CBP’s 

authority to consider the risk presented by a product in calculating bond 

amounts. 

4.1 Amend the Federal Food, Drug, and Cosmetics Act (FDCA), the 

Federal Meat Inspection Act (FMIA), the Poultry Products 

Inspection Act (PPIA), the Egg Products Inspection Act (EPIA) 

and the Consumer Product Safety Act (CPSA) to include assetforfeiture remedies for criminal offenses. This proposal would 

allow the forfeiture of all vessels, vehicles, aircraft and other 

equipment used by bad actors to aid in the importing, exporting, 

transporting, selling, receiving, acquiring or purchasing of 

products in violation of the FDCA, FMIA, PPIA, EPIA or 

CPSA, as well as the proceeds from the criminal offense. Such 

penalties would apply only to those actors who knowingly and 

willfully violate the act, and the court of record would make the 

ultimate determination of relief. This action would be wholly 

administered by the Department of Justice (DOJ) consistent with 

current practice under many statutes.8

 

 Lead: DOJ 

 Time Frame: Short Term 

4.2 Raise the statutory civil penalty cap under the CPSA. Currently, 

the penalty cap stands at $1.8 million for any related series of 

violations under the CPSA. Raising this amount to $10 million 

would serve as a deterrent to unlawful conduct and provide the 

CPSC with leverage to negotiate penalties against violators. In 

 

8 For example, Congress limited all criminal forfeiture and the civil forfeiture of real property 

for drug offenses to felony violations of the Controlled Substances Act (see 21 U.S.C 853 (a) 

and 881 (a) (7)). So, too, could Congress limit forfeiture sanctions to the statutory provisions 

that require a knowing and willful violation. 

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assessing penalties, the CPSC should consider whether a 

company is a repeat offender. 

 Lead: CPSC 

Time Frame: Short Term 

4.3 Strengthen CBP’s mitigation guidelines and increase the 

maximum penalties against importers who repeatedly import 

products that violate U.S. law. CBP needs to impose maximum 

penalties against such parties to provide effective deterrence. 

 Lead: DHS / CBP 

 Time Frame: Short Term 

4.4 Increase the dollar amount of bonds that importers of record 

must provide to reflect inflationary increases and risk. Without 

an adequate bond, CBP is usable to issue and collect penalties for 

bad actors in the amount allowable by law.

 Lead: DHS / CBP

 Time Frame: Short Term 

4.5 Authorize FDA to refuse admission of imported products if 

access -- including access to all applicable records, equipment, 

finished and unfinished materials, containers and labeling-- to 

any factory, warehouse or establishment in which a product for 

export to the United States is manufactured, processed, packed 

or held is unduly delayed, limited or denied. An important tool 

for the federal government to verify whether a firm complies 

with U.S. safety standards is to conduct a routine inspection and 

to review relevant production and distribution records. Domestic 

firms have an incentive to work with federal departments and 

agencies with such inspection authority because efforts to delay, 

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Action Plan for Import Safety: A roadmap for continual improvement 

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limit or deny such an inspection may lead to an enforcement 

action. However, foreign firms can often deny U.S. officials 

access to their facilities without any adverse consequence. 

Having the authority to prevent entry of products from firms that 

fail to provide FDA access will enable FDA to protect consumers 

by keeping potentially unsafe products from entering U.S. 

markets. This authority also will provide a strong incentive for 

foreign firms to allow FDA to perform inspections, motivation 

similar to that provided to domestic firms. 

 Lead: HHS / FDA 

Time Frame: Short Term 

4.6 Provide authority for the destruction of medical products refused 

admission into the United States. The federal government has 

had limited success in stopping unsafe medical products for 

personal use from entering the United States because of the 

statutory requirements that must be met before those products are 

destroyed. Expedited destruction of these products would 

address this limitation but would only apply to refused shipments 

that are valued below a certain threshold or which pose a certain 

level of risk to humans or animals. This is intended to address 

problems, such as personal shipments of drugs being re-imported 

after they have been denied entry. 

 Lead: HHS / FDA 

 Time Frame: Short Term 

4.7 Remove the notice requirement for violations of the CPSA. 

Under its enabling statute, the CPSC must first provide the 

offending party with notice of its violation prior to prosecution 

by the DOJ. Although the notice requirement is designed to 

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ensure that a violating firm was aware of its offense prior to 

prosecution, the standards for prosecution are such that the DOJ 

must prove knowledge and intent on the part of the offender. 

Thus, the notice requirement in the CPSA is unnecessary. 

Leads: DOJ, CPSC 

 Time Frame: Short Term 

Foreign Collaboration and Capacity Building 

Recommendation 5 – Make Product Safety An Important Principle of our 

Diplomatic Relationships with Foreign Countries and Increase the Profile of 

Relevant Foreign Assistance Activities. 

In the global economy, import safety begins abroad. While many of our trade 

partners have active and effective programs, some lack an adequate regulatory 

regime or legal system, both of which are conducive to maintaining and 

enforcing adequate product safety standards. U.S. investment in capacity 

building can benefit developing nations by helping them strengthen their 

economies, enhance their legal systems and public health infrastructure and 

ultimately facilitate commerce. 

While many federal departments and agencies offer capacity-building support to 

foreign countries, and many U.S. assistance programs provide training in the 

rule of law and government oversight of products standards and testing, the 

United States needs to reinforce the importance of product safety as a priority in 

our broader diplomatic relationships. 

For example, in order to develop foreign regulatory capacity building and 

accountability, the United States needs to advance import safety when 

negotiating cooperative arrangements with other countries. Further, the United 

States needs to build effective coalitions with our trading partners and 

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Action Plan for Import Safety: A roadmap for continual improvement 

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encourage them to become more involved in identifying solutions to product 

safety challenges. 

In addition to building the regulatory capacity of foreign governments, it is vital 

that the United States share information with foreign counterparts who have 

active and effective regulatory programs. There is currently information in the 

hands of foreign governments — such as foreign inspection results, best 

practices, adverse event reports and data on recalls and outbreaks — that could 

be useful to U.S. regulatory agencies to better screen products arriving at the 

border. For example, FDA has begun an active information-sharing program 

with many of its foreign counterparts to obtain information about product 

approval, inspection, testing and safety for FDA-regulated food, medical 

products and cosmetics. 

5.1 Direct the federal government to make product safety a guiding 

principle in negotiating future cooperative arrangements with 

foreign government entities. To foster effective relationships 

with foreign government counterparts and demonstrate the 

importance of product safety in international trade, the United 

States should make product safety an important component of 

cooperative arrangements. 

 Lead: Executive Office of the President (EOP) 

 Time Frame: Short Term 

5.2 Expand and administratively streamline, as appropriate, 

government inspections in foreign countries and improve 

collaborative investigation and enforcement activities when 

negotiating cooperative arrangements with foreign governments.

Streamlining bureaucratic processes, such as the visa process for 

government inspectors, can result in more-timely and less-costly 

authorized foreign inspections. In addition, as appropriate, 

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federal departments and agencies should provide foreign 

countries with training and technical assistance regarding U.S. 

standards and conformity assessment practices. 

 Lead: Department of State 

 Time Frame: Long Term 

5.3 Review existing overseas programs that target rule of law, 

regulatory capacity-building and trade capacity-building, to 

determine how to improve product safety standards and conduct.

This would encourage departments and agencies with relevant 

programs to include product safety standards and compliance, 

where appropriate, in their capacity-building efforts. Existing 

foreign assistance efforts related to strengthening the rule of law, 

regulatory capacity-building 

and trade capacity-building 

may currently seek to 

improve product safety 

standards and compliance. 

However, there has been no 

coordinated policy review of 

these efforts to help policy makers understand if the level of 

effort is appropriate and effective and to ensure consistency in 

U.S. policy.

 Lead: Department of State 

 Time Frame: Long Term 

5.4 Improve U.S. liaison to foreign countries. For example, establish 

FDA field presence at key foreign ports of embarkation and a 

CPSC liaison to certain countries. 

Leads: HHS / FDA, CPSC 

Strengthen the Capacities of Our Trading 

Partners 

One way to ensure compliance with United 

States safety standards, if warranted, is to 

increase the capacity of our trading partners 

to adopt strong safety standards and 

regulations and to develop a legal system 

that is capable of enforcing those standards. 

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36

 Time Frame: Long Term 

 

5.5 Develop strategic information sharing arrangements with key 

foreign government counterparts. Through greater informationsharing, such as data on recalls, the federal government can 

leverage the inspection and regulatory expertise and experience 

of foreign regulatory authorities to facilitate admissibility 

determinations, provide advance notice of problems, and 

enhance enforcement capabilities. 

 Leads: HHS / FDA, USDA, CPSC, EPA 

 Time Frame: Long Term 
Action Plan for Import Safety: A roadmap for continual improvement 

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Intervention 

The second organizing principle—Intervention—recognizes the need to 

intervene when risks to product safety are identified. These recommendations 

address the importance of focusing intervention activities throughout the life 

cycle of imported products, rather than just at the time the goods arrive at the 

U.S. border. To accomplish this, the federal government will need to put in 

place automated systems and foster a culture that optimizes both government 

and private-sector knowledge. The incompatible systems that comprise the 

current approach must be replaced with interoperable systems that provide all 

regulatory departments and agencies, as well as the importing community, with 

the most complete information possible while 

protecting confidential information. This will 

allow federal agencies, either prior to shipment, at 

the port-of-arrival, or at the port-of-entry, to 

effectively target shipments that may represent a 

risk if allowed entry into the United States. This 

would maximize the use of federal resources and 

facilitate legitimate trade, as well as assist the 

importing community in meeting its responsibility 

to ensure unsafe products do not enter the United 

States. 

Partnership 

The government and the trade community 

must build cooperative relationships that 

strengthen and improve import safety. The 

federal government can provide the highest 

level of safety only through close cooperation 

with all parties involved in the import life 

cycle. With the continually increasing volume 

and complexity of international trade, 

cooperation and partnership with industry is 

paramount for successful implementation of 

any import-safety program or requirement. 

Partnerships underscore the importance of 

employing industry best practices to secure the 

import life cycle and serve as a force 

multiplier for federal regulatory authorities. 

Common Mission 

Recommendation 6 – Harmonize Federal Government Procedures and 

Requirements for Processing Import Shipments.

Border officials inspect and clear cargo before it enters the United States in 

accordance with relevant federal laws and regulations. New risk information 

can complicate efforts to conduct inspections of entering shipments consistent 

with the applicable admissibility requirements. Better coordination among 

federal regulatory departments and agencies; cross-training; commissioning of 

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38

federal personnel in the application of import entry requirements; and the 

establishment of common inspection, testing and enforcement protocols are 

needed, in some cases, to ensure that only products that comply with relevant 

regulations and standards enter domestic commerce, and that federal efforts to 

achieve this goal are effective and efficient. 

6.1 Develop uniform interdepartmental procedures, where 

appropriate, for clearing and controlling shipments at ports-ofentry. These procedures would be used by all federal 

departments and agencies, where appropriate, and would help 

streamline the entry process as well as facilitate the exchange of 

information and intelligence, processing of samples and 

interagency coordination so that federal resources are used more 

efficiently and effectively in assuring product safety. As part of 

this action, federal departments and agencies with border 

regulatory responsibilities should develop and deliver crosstraining, where necessary, to keep the agencies updated on 

current U.S. import requirements. 

 Leads: DHS / CBP, USDA, HHS / FDA, CPSC, EPA 

 Time Frame: Short Term 

6.2 Develop a strategic plan for rapid response to import-safety 

incidents. To implement an effective rapid response requires 

coordination among all the involved parties. This plan would 

identify the roles and responsibilities of the federal departments 

and agencies; include a communication plan with state and local 

governments, private industry, foreign governments, the media 

and others; and include a business resumption model, as 

applicable. 

 
Action Plan for Import Safety: A roadmap for continual improvement 

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Leads: DHS / CBP, USDA, HHS / FDA, CPSC, EPA 

 Time Frame: Short Term 

6.3 Co-locate border officials from multiple agencies, when feasible, 

to enhance targeting and risk-management decisions on import 

safety. Border officials can work together more effectively when 

stationed at the same location. The federal government has colocated border officials in limited locations in the past, including 

CBP’s National Targeting Center (NTC)9

, resulting in improved 

coordination and more effective operations. 

 Leads: DHS / CBP, HHS / FDA, USDA / FSIS, CPSC 

 Time Frame: Long Term 

6.4 Exercise commissioning and cross-designation authority to 

leverage federal resources to prevent unsafe products from 

reaching consumers in the United States. Under this model, 

participating agencies would agree that one agency would act 

under the authority of the other to carry out select activities, such 

as audits and lab processing, dependent on capacity constraints. 

Commissioning is particularly helpful when one agency has staff 

at a location where the other does not. 

 Leads: DHS / CBP, HHS / FDA, USDA / FSIS, CPSC 

 Time Frame: Long Term 

9

 The NTC is a CBP facility where federal officials are co-located to enable better riskassessment and targeting of imported cargo. 

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Interoperability 

Recommendation 7 – Complete a Single-Window Interface for the Intraagency, Interagency and Private-sector Exchange of Import Data. 

In Fiscal Year 2006, 31.3 million entries were filed with CBP for import 

shipments. Today, interactions between the government and importing 

community frequently involve time-consuming, resource-intensive paper 

reporting. The Automated Commercial Environment (ACE), which is currently 

being developed, will provide an automated “single-window” system for 

processing the entry of import shipments.10 Information about imported 

commodities will be collected for all federal departments and agencies involved 

in the importing of goods. Through ACE, the importing community, CBP and 

other federal departments and agencies will exchange real-time data about 

products, compliance and revenue for each import transaction. The federal 

government would therefore base a decision to clear or reject an import 

shipment for entry into the United States upon an immediate information 

exchange. This would facilitate cargo movements as well as more effective risk 

determinations and enforcement actions. 

The Safety and Accountability for Every (SAFE) Port Act of 2006 makes 

implementation of the single-window concept a mandatory requirement for 

federal departments and agencies with import and export responsibilities.11 

Agencies that license, permit, or certify the importation of products into the 

United States must establish an electronic interface with CBP’s ACE system as 

part of the International Trade Data System (ITDS) initiative. ITDS is 

developing a Standard Data Set (SDS) of data elements to be used in reporting 

international trade transactions, which will facilitate exchanging data among all 

10 The Immediate Actions Memorandum (September 10, 2007) required that the implementation 

of ITDS be accelerated. 

11 The Act permits the Office of Management and Budget (OMB) to exempt certain agencies. 

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parties involved with an import transaction including regulatory and 

enforcement agencies. 

7.1 Require federal departments and agencies by the end of 2009 to 

have the capability to exchange commercial data and, to the 

extent allowable by law, communicate electronically with the 

importing community and other departments and agencies 

through ACE / ITDS. ACE / ITDS will permit integration of 

import data collected by federal departments and agencies to 

facilitate decision-making on the safety of imports. As part of 

this action step, departments and 

agencies, in partnership with the 

importing community, should 

develop a coding system for 

imported products and 

participants in the import life 

cycle, as well as draft any 

regulations necessary for 

implementation. The coding 

system will provide greater specificity than currently provided 

under the Harmonized Tariff Schedule (HTS) and will, thus, help 

identify products more quickly and accurately. The necessary 

regulations will be issued by the participating departments and 

agencies with jurisdiction. 

 Lead: DHS/CBP and Treasury as executive agents 

 Time Frame: Long Term 

7.2 Develop, as appropriate, within the Automated Targeting System 

(ATS), risk-based screening technologies to target high-risk 

products in a more effective way and facilitate the entry of lowrisk products. Such technologies would use information available 

ACE / ITDS Data 

In 2006, the Food Safety and Inspection 

Service (FSIS) gained access to data from 

Customs and Border Protection’s (CBP) 

Automated Commercial Environment 

(ACE). Since then, detection of illegallyentered meat and poultry products has 

increased 60-fold. These products have 

either been destroyed or returned to FSIS for 

import re-inspection. In all, FSIS has 

prevented over 3.5 million pounds of illegal 

meat and poultry products from entering 

United States commerce. 

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42

through ATS to facilitate risk determinations by federal 

department and agency officials, thereby expediting the entry of 

safe and secure products and allowing departments and agencies 

to better target their resources on high-risk products. 

 Lead: DHS / CBP 

 Time Frame: Long Term 

7.3 Develop an implementation plan for the integration of the 

Standard Establishment Data Service (SEDS) module into 

ACE/ITDS. SEDS would create a centralized service to provide 

accurate information on the import supply chain. It would 

provide unique standard identifiers for establishments (to 

facilitate verification of involvement) and capture a minimal set 

of establishment violation data from import transactions at the 

central source. 

Leads: DHS / CBP, USDA, HHS / FDA, EPA, Commerce 

Time Frame: Long Term 

Information Gathering 

Recommendation 8 – Create an Interactive Import-Safety Information 

Network.

Receipt of advance safety and security data regarding the product, the country 

of export, the manufacturer, the carrier and the importer prior to export of 

merchandise allows for a preliminary analysis of import-safety. Analysis of the 

data is critical to making risk-based determinations on actions to be taken by 

border officials prior to loading shipments in the exporting country and while 

they are in transit to the United States. In many cases, making these decisions 

for further review and examination prior to arrival of the shipment can facilitate 

the clearance of legitimate trade at the time of arrival in the United States. 
Action Plan for Import Safety: A roadmap for continual improvement 

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For example, the Trade Act of 2002 requires carriers to provide limited data 

elements prior to loading shipments for export to the United States. The Trade 

Act provisions apply to all modes of transportation. The 2006 SAFE Port Act 

allows CBP to collect additional information that is reasonable for security 

purposes prior to the loading of maritime cargo destined for export to the United 

States. 

8.1 Expand upon existing public-private relationships to seek and 

share the importing community’s recommendations and best 

practices with other federal departments and agencies for import 

safety and security purposes, and provide training in accessing 

this information. The importing community has a great deal of 

information about the product life-cycle that would assist the 

federal government in its enforcement and compliance actions. 

Use of this data could allow federal departments and agencies to 

make early determinations of import risk based on data already 

being collected. 

 Lead: DHS / CBP 

 Time Frame: Short Term 

8.2 Identify whether additional information is necessary to enhance 

import safety as allowed for under the SAFE Port Act. After 

gaining experience with information gathered under the SAFE 

Port Act, the federal government, working with the importing 

community, may conclude that access to additional security 

information is necessary to make admissibility determinations 

based on risk. 

 Lead: DHS / CBP 

 Time Frame: Long Term 

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8.3 Seek legislation that would provide CBP authority to extend 

reporting requirements for maritime shipments under the SAFE 

Port Act to all modes of transportation. This would allow CBP 

to require both importers and carriers to submit additional 

information pertaining to cargo before the cargo is brought into 

the United States. The information would improve the ability of 

CBP to identify and target high-risk shipments in order to 

prevent smuggling and ensure cargo safety and security. CBP 

would exercise this authority through notice and comment 

rulemaking. 

 Lead: DHS / CBP 

 Time Frame: Short Term 

8.4 Develop a private-sector import-safety interactive information 

exchange process. The Department of Homeland Security 

(DHS) would work with the importing community to address a 

means for the private-sector to report critical import-safety 

information in a timely manner at one virtual location through 

existing information-sharing systems. DHS would also use this 

means to share information with the private-sector. 

 Lead: DHS 

 Time Frame: Short Term 

New Science 

Recommendation 9 – Expand Laboratory Capacity and Develop Rapid Test 

Methods for Swift Identification of Hazards. 

Advancement in the discovery, development and application of science and 

technology to detect problems in imported products more rapidly is essential for 

effective intervention strategies. Through research to develop more and better 

detection tools and to improve the reliability of existing tools, the federal 

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Action Plan for Import Safety: A roadmap for continual improvement 

government and the private-sector can detect contaminants and defects more 

quickly and accurately. These tools could include real-time diagnostic 

instruments and methodologies that allow for 

rapid, on-site analysis of a particular product, 

especially those that are high-risk. For 

example, technology that would allow rapid 

detection of a contaminant could be expanded 

to cover food types such as produce and dairy 

products, reducing analysis time from days to 

minutes and improving the accuracy of test 

results. New tools would also be developed to 

identify additional pathogens. Increasing the 

speed at which federal departments and 

agencies can detect problems will allow those departments and agencies to take 

more rapid action, including expediting import entry review decisions and 

providing critical health information to the public when a problem is identified 

with a product in commerce. 

Laboratory capacity is critical to rapid response to product emergencies. 

For example, the Food Emergency Response Network (FERN) is a 

nationwide network made up of more than 130 federal, state and local 

public health laboratories that support emergency-response activities 

related to food defense and food safety. FERN also provides training to 

member laboratories to use new testing methods and provides funding of 

selected state laboratories through cooperative agreements. 

Another example is the Electronic Laboratory Exchange Network 

(eLEXNET). eLEXNET is a seamless, integrated, secure network that 

allows multiple federal, state and local government agencies engaged in 

food safety activities to compare, communicate and coordinate findings in 

Support from the Scientific Community 

During the recent event involving melamine 

contamination of imported gluten-vegetable 

protein, the National Center for Food 

Protection and Defense (NCFPD) provided 

subject matter expertise and real-time data 

analysis to assist federal agencies in 

responding. NCFPD also developed a case 

study including lessons learned and key 

unknowns, conducted a rapid assessment of 

imported food risks, and initiated a joint 

research project on imported food 

vulnerabilities and solutions with FDA and 

FSIS. 

www.importsafety.gov 

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46

laboratory analyses by using information technology tools. The system 

enables U.S. health officials to assess risks, analyze trends and identify 

problem products. It provides the necessary infrastructure for an earlywarning system that identifies potentially hazardous foods and enhances 

the effectiveness of federal-state collaboration.

Ongoing efforts to enhance import safety will benefit from current and 

future contributions from the academic community. In addition to the 

obvious role of educating and training the next generation of professionals 

and experts, academia is an important resource for innovating new 

solutions for import safety. For example, subject matter experts from the 

academic community provided advice, incident monitoring, event 

assessment and the capturing of lessons learned during several recent food 

and agriculture sector incidents, such as the contamination of pet food 

with melamine and the recent foot-and-mouth disease outbreak in the 

United Kingdom. 

Basic research in new technologies, strategies and tools is a natural 

contribution to import safety from the academic community. Several 

academic centers are assisting in developing food and agriculture disease 

and product contamination monitoring tools as well as training tools and 

programs. The efforts of the academic community in developing new 

approaches for risk communication and supply chain resiliency can be 

most effectively tested and further refined via engagement with 

government. Multiple federal and state agencies, as well as the privatesector, already partner with and support research in the academic 

community. 

9.1 Enhance field laboratory capacity for testing and work 

collaboratively with the public and private-sectors to 

develop analytical tools for enhanced rapid screening of 
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larger volumes of import samples. This will allow the 

federal government to detect risks and take actions to 

remove problem products from commerce more quickly 

and effectively. 

 Leads: DHS / CBP, USDA / FSIS, HHS / FDA, CPSC 

 Time Frame: Long Term 

9.2 Increase the capacity and capability of FERN laboratories 

by developing and validating methods to increase the 

number of chemical, radiological and microbial threat 

agents that can be rapidly detected in food as well as 

broadening the reach of the methods to allow foreign 

laboratories to provide information. Ensuring adequate 

capacity and capability of FERN provides a strong surge 

capacity that is independent of FDA, USDA and EPA 

laboratory operations. 

 Lead: HHS / FDA, USDA / FSIS 

 Time Frame: Long Term 

9.3 Develop rapid test methods for pathogens and other 

contaminants to ensure that test results are quickly available at 

ports-of-entry for determining whether or not a product should 

be admitted into the United States. 

 Leads: HHS / FDA, USDA 

 Time Frame: Long Term 

9.4 Increase the quantity and quality of data submitted by 

participating laboratories to eLEXNET. FDA would create an 

automatic data exchange, which would increase the quantity of 

samples and/or analytes (the components of laboratory tests) a 

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laboratory is able to submit, increase the frequency and 

timeliness of data submission and ensure a better degree of data 

integrity as compared to manual data entry. This action step 

would enhance the effectiveness of federal and state laboratorytesting capabilities to protect American consumers.

 Lead: HHS / FDA, USDA / FSIS 

 Time Frame: Long Term 

Intellectual Property Protection 

Recommendation 10 – Strengthen Protection of Intellectual Property Rights 

(IPR) to Enhance Consumer Safety. 

Strong IPR enforcement is essential to the protection of public health and 

safety. Counterfeit trademarked goods purporting to be made and marketed by 

someone other than the owner of the 

mark not only pose a threat to public 

safety, but undermine confidence in the 

quality of brand name products. These 

illegal activities also result in billions of 

dollars of lost revenue, investment, 

future sales and growth opportunities 

and harm legitimate businesses and workers who play pivotal roles in creating, 

manufacturing, distributing and selling genuine and safe products. The public 

and private-sectors must work in concert to identify infringing and potentially 

unsafe goods and prevent them from entering the domestic marketplace. 

Patents protect the design, formulae and content of a wide variety of 

manufactured products, consumer goods and pharmaceuticals. Trademarks 

protect the brand name of known and trusted companies so that consumers can 

be sure they are getting the same quality product that they expect to obtain 

Safety and Intellectual Property 

It is critical that the federal government continue 

to work with trading partners to improve the 

protection and enforcement of intellectual 

property rights because counterfeit products can 

pose significant safety risks.

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under that mark. When patents are infringed, consumers suffer because 

infringers create disincentives to the invention of new products and processes. 

Patent infringement may be accompanied by counterfeiting and trademark 

infringement. When look-alike knock-off and counterfeit products violate 

trademarks, consumers cannot be certain of the quality or origin of the knockoff product. In addition, because infringing products are often substandard in 

quality, they can harm consumers in myriad ways and pose serious health and 

safety risks. For example, a counterfeit drug may have too little, too much or no 

active ingredient or contain a toxic contaminant, possibly putting consumers at 

risk for serious adverse events or worsened health from ineffective treatment of 

their underlying medical condition.

10.1 Focus the work of the interagency Strategy Targeting Organized 

Piracy (S.T.O.P.) and the United States government-privatesector Coalition against Counterfeiting and Piracy Initiative on 

import-safety issues. STOP focuses on empowering American 

innovators to protect better their rights at home and abroad, 

increasing efforts to seize counterfeit goods at U.S. borders, 

pursuing criminal enterprises involved in piracy and 

counterfeiting, working closely and creatively with U.S. industry 

and aggressively engaging trading partners to join U.S. efforts. 

The Coalition Against Counterfeiting and Piracy encourages 

close cooperation between the public and private-sectors to 

effectively secure supply chains and protect consumers and 

rights holders. 

 Lead: Department of Commerce 

 Time Frame: Short Term 

10.2 Expand information-sharing about counterfeit and other goods 

that infringe IPR among relevant U.S. departments and agencies 
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to identify and target products, manufacturers and distributors 

with potential safety violations. The International Intellectual 

Property Enforcement Coordinator, housed at the Department of 

Commerce, is responsible for disseminating information and 

coordinating actions on IPR among federal departments and 

agencies, primarily Commerce, DOJ, USTR, DHS and State. 

With a new emphasis on ensuring import safety, the Coordinator 

will extend its outreach and coordination activities to include 

agencies responsible for import-safety inspections, such as FDA, 

CPSC and USDA. In addition, with the anticipated increase in 

private entity certifiers for U.S. safety requirements, it is 

essential to enhance interagency IPR coordination to include 

these inspecting agencies.

 Lead: Department of Commerce 

 Time Frame: Short Term 

10.3 Encourage companies that have registered trademarks with the 

U.S. Patent and Trademark Office (USPTO) to record their 

registrations with CBP. Industries must record their trademarks 

with CBP to enable CBP to identify, seize and destroy infringing 

and potentially unsafe goods. 

 Lead: DOC 

 Time Frame: Short Term 

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Response 

In the event that an unsafe import does make its way into the domestic stream of 

commerce and may or does injure consumers or animals, swift actions must be 

taken to limit potential exposure and harm. 

Recall 

Recommendation 11 – Maximize the Effectiveness of Product Recalls. 

The recall process is the principal tool in the arsenal of response mechanisms to 

protect consumers from exposure to hazardous products whether the products 

are domestic or imported. Generally, the manufacturer, distributor, importer or 

retailer initiates a product recall with the cooperation of the appropriate 

government agency (e.g., FDA for most foods and CPSC for consumer goods). 

11.1 Amend the CPSA to make it unlawful for any manufacturer, 

distributor or retailer to sell a recalled product knowingly and 

willfully after the date of public announcement of the recall. 

Under the CPSA, it is currently legal for such entities to sell a 

recalled product (other than a product that fails to comply with a 

mandatory standard or ban) even after the public announcement 

of the recall. Amending the CPSA will create proper incentives 

for retailers and distributors to halt sales of recalled products as 

quickly as possible. 

 Lead: CPSC 

 Time Frame: Short Term 

11.2 Authorize follow-up recall authority for CPSC. If, after public 

notice of a voluntary recall, it later comes to the attention of the 

Commission that products subject to the voluntary recall remain 

widely available on the market, this provision would allow the 

agency to act quickly to issue an identical follow-up recall notice 

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without having to consult again with the subject firm. This 

authority would be particularly helpful in instances of highvolume recalls in which one announcement may prove 

inadequate to inform the public. 

 Lead: CPSC 

 Time Frame: Short Term 

11.3 Authorize CPSC to require all recalling firms to provide the 

name and address of companies that supplied or received the 

recalled product. Although maintaining thorough and accurate 

information about product suppliers, manufacturers and 

distributors is widely viewed as an industry best practice, not all 

firms maintain such information. Others do not disclose it to the 

Commission in the event of a recall. With proper authority, the 

CPSC could require every recalling entity to provide the agency 

with detailed contact information for all relevant parties across 

the life cycle of the recalled product. Granting the CPSC 

authority to compel such information in times of recall creates an 

incentive for firms to adopt strong record-keeping practices as a 

matter of standard business operations. 

 Lead: CPSC 

 Time Frame: Short Term 

11.4 Authorize FDA to issue a mandatory recall of food products 

when voluntary recalls are not effective. Currently, FDA lacks 

the authority to require the recall of food, including food it 

reasonably believes is adulterated and presents a threat of serious 

adverse health consequences or death. Although market 

incentives have made the voluntary recall system generally 

effective, providing mandatory recall authority to FDA when the 

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voluntary system is not successful would ensure that the agency 

has the ability to compel action in those instances when firms 

have refused or unduly delayed a voluntary recall of food. The 

authority would provide for appropriate due process rights for 

any firm subject to a recall order.

Lead: HHS / FDA 

 Time Frame: Short term 

Federal-State Rapid Response 

Recommendation 12 – Maximize Federal-State Collaboration. 

The roles of and the resources used by the federal government and the states in 

import safety are complementary. States possess legislative authority and 

resources to respond to unsafe imported products within their jurisdiction. The 

federal government can take steps to interdict unsafe imported goods at portsof-entry. Should an unsafe product enter domestic commerce, federal 

departments and agencies often work with state authorities to track it down, 

seize it, notify the public if it has already been purchased by consumers and 

impose appropriate penalties on domestic entities who violate U.S. law. Also, 

both the federal government and states may have access to information relevant 

to protecting consumers that the other does not possess. For example, federal 

departments and agencies may have relevant information about the foreign 

source of the imported product and about the importer. This information can 

help state officials track down an unsafe imported product within their 

jurisdiction. On the other hand, state officials may identify an unsafe imported 

product during transport or at the point-of-sale, if the product does get into the 

country, and can tip off federal officials to prevent future shipments from 

entering domestic commerce. 

Several federal departments and agencies already collaborate closely with state 

authorities to protect consumers. For example, FDA has contracts and 

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cooperative agreements with state governments to share information, conduct 

joint inspections and collaborate on laboratory analyses. Greater mutual 

leveraging of state and federal resources can further enhance consumer 

protection. 

12.1 Consider cooperative agreements between the federal inspection 

agencies and their state counterparts for greater informationsharing. Such cooperative agreements would not infringe on the 

statutory authorities of federal or state regulators and would 

encourage a coordinated effort that would result in a more rapid 

and effective response. Establishing clear procedures and pointsof-contact for information sharing and joint enforcement efforts 

can further enhance the effectiveness of federal-state actions to 

limit exposure and potential harm to consumers if an unsafe 

imported product makes it into domestic commerce. 

 Leads: HHS / FDA, USDA, CPSC, EPA 

 Time Frame: Long Term 

12.2 Review admissibility policies to improve the use of evidence and 

laboratory results from state investigations of imported products. 

Currently, there are limitations on the use of state-developed 

evidence in federal court cases due to the gathering, analysis and 

retention of such evidence by non-federal government entities. 

Being able to use this evidence would make it easier for federal 

departments and agencies to take enforcement actions against 

bad actors. 

 Leads: DOJ, HHS / FDA, USDA, CPSC 

 Time Frame: Short Term 

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Technology 

Technological advancements can help industry, as well as federal and state 

governments, more effectively respond to safety incidents involving imports. 

Recommendation 13 – Expedite Consumer Notification of Product Recalls. 

After a manufacturer has recalled an imported product because of safety 

concerns, it is essential for consumers to receive notification of the recall as 

quickly as possible. While government and industry work largely in 

cooperation to enact product recalls, the emergence of new technologies may 

permit an even more rapid and efficient response. 

13.1 Develop best practices for the use of technologies to expedite 

consumer notification of recalls. With advances in producttracking technologies, such as integrated circuit cards (Smart 

Cards) and Radio Frequency Identification (RFID), retailers are 

increasingly capable of learning and anticipating their customers’ 

preferences, both as individuals and cohorts. Information 

collected at the point-of-sale, provided voluntarily by consumers 

in exchange for product discounts and other benefits, has 

significant potential in the realm of product safety. For example, 

consumers who voluntarily share their personal contact 

information with a retailer (email address, telephone number, 

etc.) also can agree to receive instant recall notification from the 

seller regarding any of the products they recently purchased at 

that store. To the extent that the private-sector can leverage the 

use of Smart Cards, RFID and other technologies to expedite 

consumer notification of emerging or existing product hazards 

while adequately protecting consumer privacy, the government 

should support such efforts. 

 Leads: USDA, HHS / FDA, CP

 Time Frame: Long Term 

SC 

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Track-and-Trace 

Recommendation 14 – Expand the Use of Electronic Track-and-Trace 

Technologies. 

Traceability is the capacity to identify and track a product or group of products 

along the import life cycle, including at all points throughout the sourcing, 

manufacturing and distribution chain. The ability to identify the product source 

and points of distribution across the import life cycle is of prime importance for 

the protection of consumers, particularly in the event of a product recall. If 

unsafe imports are discovered, effective traceability mechanisms can facilitate 

timely product recovery and reduce the opportunity for harm to occur. 

Additionally, the capacity to connect the dots and link import life cycle 

information back to the point of origin enables both government and privatesector actors to provide consumers with targeted and accurate information 

concerning implicated products. Traceability is also an effective preventive tool 

in that post-recall information and feedback can be processed to identify and 

address weaknesses across the import life cycle. 

14.1 Work with foreign and domestic industry to encourage the 

development of best practices for the use of electronic track-andtrace technologies. 

 Leads: USDA, HHS / FDA, CPSC, DOT 

 Time Frame: Long Term 

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Conclusion 

www.importsafety.gov 

This Action Plan creates a roadmap for short-term and long-term improvements 

in the safety of imported products. The Working Group sets forth 14 

recommendations and 50 action steps that are based on the organizing principles 

and building blocks identified in the Strategic Framework released on 

September 10, 2007. In addition, at the same time as the release of the Strategic 

Framework, the Working Group outlined Immediate Actions to be taken by 

federal departments and agencies to effect meaningful change. Together, the 

Strategic Framework and this Action Plan provide a national strategy for 

continually improving the safety of imported products. 

The recommendations in this Action Plan create a path for the United States to 

complete the shift from an intervention approach to a prevention with 

verification, risk-based approach that builds safety into the products that reach 

U.S. consumers. This shift in emphasis can occur by following these 

recommendations: 

1. Safety Standards: Create new and strengthen existing safety standards. 

2. Certification: Verify compliance of foreign producers with U.S. safety 

and security standards through certification. 

3. Good Importer Practices: Promote Good Importer Practices. 

4. Penalties: Strengthen penalties and take strong enforcement actions to 

ensure accountability. 

5. Foreign Collaboration and Capacity Building: Make product safety an 

important principle of our diplomatic relationships with foreign 

countries and increase the profile of relevant foreign assistance 

activities. 

6. Common Mission: Harmonize federal government procedures and 

requirements for processing import shipments. 

7. Interoperability: Complete a single-window interface for the intraagency, interagency and private-sector exchange of import data. 

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8. Information Gathering: Create an interactive import-safety information 

network. 

9. New Science: Expand laboratory capacity and develop rapid test 

methods for swift identification of hazards. 

10. Intellectual Property Protection: Strengthen protection of intellectual 

property rights (IPR) to enhance consumer safety. 

11. Recall: Maximize the effectiveness of product recalls. 

12. Federal-State Rapid Response: Maximize federal-state collaboration. 

13. Technology: Expedite consumer notification of product recalls. 

14. Track-and-Trace: Expand the use of electronic track-and-trace 

technologies. 

Key action steps, which provide the pathway for implementing these 

recommendations, have each been assigned to lead entities that will be 

responsible for implementing this Action Plan. 

Implementation of the recommendations will require resources, including 

reallocation of existing resources, as well as trade-offs, to fund these priorities. 

Additionally, it will require expanded authorities, greater coordination among 

federal departments and agencies, improved accountability for industry, 

increased foreign capacity building greater information-sharing, partnerships 

with the private-sector and the application of new science, to name just some of 

the activities the federal government must place priority on in coming years. 

Implementation will also require a collaborative approach by all participants in 

the import safety life cycle. By doing so, American consumers will be able to 

continue to enjoy the benefits of the global economy with confidence. 

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Action Plan for Import Safety: A roadmap for continual improvement 

Appendix A: Executive Order 

www.importsafety.gov 

Executive Order: Establishing An Interagency Working Group on Import 

Safety 

By the authority vested in me as President by the Constitution and the laws of 

the United States of America, and to ensure that the executive branch takes all 

appropriate steps to promote the safety of imported products, it is hereby 

ordered as follows: 

Section 1. Establishment of Interagency Working Group on Import Safety. The 

Secretary of Health and Human Services shall establish within the Department 

of Health and Human Services for administrative purposes only an Interagency 

Working Group on Import Safety (Working Group). 

 Sec. 2. Membership and Operation of Working Group. 

(a) The Working Group shall consist exclusively of the following members, or 

their designees who shall be officers of the U.S. appointed by the President or 

members of the Senior Executive Service: 

(i) the Secretary of Health and Human Services, who shall serve as Chair; 

(ii) the Secretary of State; 

(iii) the Secretary of the Treasury; 

(iv) the Attorney General; 

(v) the Secretary of Agriculture; 

(vi) the Secretary of Commerce; 

(vii) the Secretary of Transportation; 

(viii) the Secretary of Homeland Security; 

(ix) the Director of the Office of Management and Budget; 

(x) the United States Trade Representative; 

(xi) the Administrator of the Environmental Protection Agency; 

(xii) the Chairman of the Consumer Product Safety Commission; and 

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(xiii) other officers or full-time or permanent part-time employees of the 

United States, as determined by the Chair, with the concurrence of the head of 

the department or agency concerned. 

(b) The Chair shall convene and preside at meetings of the Working Group, 

determine its agenda, and direct its work. The Chair may establish and direct 

subgroups of the Working Group, as appropriate to deal with particular 

subject matters, that shall consist exclusively of members of the Working 

Group. The Chair shall designate an officer or employee of the Department 

of Health and Human Services to serve as the Executive Secretary of the 

Working Group. The Executive Secretary shall head any staff assigned to 

the Working Group and any subgroups thereof, and such staff shall consist 

exclusively of full-time or permanent part-time Federal employees. 

Sec. 3. Mission of Working Group. The mission of the Working Group shall 

be to identify actions and appropriate steps that can be pursued, within existing 

resources, to promote the safety of imported products, including the following: 

(a) reviewing or assessing current procedures and methods aimed at 

ensuring the safety of products exported to the United States, including 

reviewing existing cooperation with foreign governments, foreign 

manufacturers, and others in the exporting country's private-sector regarding 

their inspection and certification of exported goods and factories producing 

exported goods and considering whether additional initiatives should be 

undertaken with respect to exporting countries or companies; 

(b) identifying potential means to promote all appropriate steps by U.S. 

importers to enhance the safety of imported products, including identifying 

best practices by U.S. importers in selection of foreign manufacturers, 

inspecting manufacturing facilities, inspecting goods produced on their 

behalf either before export or before distribution in the United States, 

identifying origin of products, and safeguarding the supply chain; and 

(c) surveying authorities and practices of Federal, State, and local 

government agencies regarding the safety of imports to identify best 

practices and enhance coordination among agencies. 

Sec. 4. Administration of Working Group. The Chair shall, to the extent 

permitted by law, provide administrative support and funding for the Working 

Group. 

Sec. 5. Recommendations of Working Group. The Working Group shall 

provide recommendations to the President, through the Assistant to the 

President for Economic Policy, on the matters set forth in section 3 within 

60 days of the date of this order, unless the Chair determines that an extension is 

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necessary. The Working Group may take other actions it considers appropriate 

to promote the safety of imported products 

Sec. 6. Termination of Working Group. Following consultation with the 

Assistant to the President for Economic Policy, the Chair shall terminate the 

Working Group upon the completion of its duties. 

Sec. 7. General Provisions. 

(a) Nothing in this order shall be construed to impair or otherwise affect (i) 

authority granted by law to a department, agency, or the head thereof, or (ii) 

functions of the Director of the Office of Management and Budget relating to 

budget, administrative, or legislative proposals. 

(b) This order shall be implemented consistent with applicable law and 

subject to the availability of appropriations. 

(c) This order is not intended to, and does not, create any right, benefit, or 

privilege, substantive or procedural, enforceable at law or in equity, by any 

party against the United States, its departments, agencies, or entities, its 

officers, employees, or agents, or any other person. 

GEORGE W. BUSH 

THE WHITE HOUSE, 

July 18, 2007. 

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Appendix B: Immediate Actions Memorandum 

September 10, 2007 

www.importsafety.gov 

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63

1. Improve collaboration and information sharing with the privatesector to improve the safety of imports. 

A wide range of products that could potentially threaten the health and 

safety of U.S. consumers are imported every day. Due to the vast 

volume of imported products, it is impossible to ensure safety simply by 

increasing government inspections. Rather, engagement with the 

importing community must be enhanced to gain insights from the 

owners and operators of the commercial import infrastructure through 

which all imported products reach American consumers, and to share 

best practices among this community. 

To conduct this outreach and improve collaboration with the importing 

community, the agencies should expand on existing public-private 

relationships, such as COAC (Commercial Operations Advisory 

Committee), TSN (Trade Support Network), F&ASCC (Food and 

Agriculture Sector Coordinating Council), ITACs and ATACs 

(Industrial Trade and Agricultural Trade Advisory Committees), and 

other groups, to seek and share the importing community’s 

recommendations and best practices with the objective of enhancing 

import safety and promoting comprehensive supply chain verification. 

Recommendations for implementation of this action will be included in 

the Working Group’s forthcoming Action Plan. 

2. Interoperability Acceleration – Instruct Executive Agencies to 

Complete Their Identification of Technical, Business and Legal 

Requirements for Operating Within the Automated Commercial 

Environment/International Trade Data System. 

The Security and Accountability for Every (“SAFE”) Port Act of 2006 

requires all Federal agencies that license, permit, or certify imported 

products to participate in the International Trade Data System (ITDS), a 

"single-window" system for reporting imports and exports 

electronically. ITDS will operate as a feature of U.S. Customs and 

Border Protection's (CBP) trade data processing system called the 

Automated Commercial Environment (ACE), which is currently under 

development. Functional capabilities within ACE are being implemented 

in stages, with full operability expected in 2009. Currently, 34 Federal 

agencies, referred to as Participating Government Agencies (PGAs), are 

at varying stages in integrating into ITDS. 

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In order to accelerate implementation of ITDS, the Office of 

Management and Budget should issue a directive to PGAs requiring that 

within 60 days of the directive they establish or refine their 

Implementation Plan setting deadlines for developing, reviewing and 

finalizing conceptual operating plans (Concept of Operations), 

memoranda of understanding for the ITDS interface, and a set of 

technical and business requirements for identifying any program and 

system modifications needed to support the interface. This would 

include considerations for the budget process. OMB should give special 

priority to import safety agencies for this task in the budget process. 

Further, in order to accelerate implementation of ITDS, the Office of 

Management and Budget should direct that CBP, within 60 days, 

establish or refine its Implementation Plan setting deadlines to: 

o Include information currently reported by importers and carriers 

to CBP in the ACE Data Warehouse, where it can be accessed by 

other agencies. 

o Advise other agencies with an import safety mission how they 

can take full advantage of current ITDS capabilities and deepen 

their engagement in ITDS development 

o Implement World Customs Organization Data Model messages 

(new international standard for customs reporting), which could 

provide a platform for electronic reporting of health and safety 

information in advance of the current ITDS production schedule. 

In addition, all PGAs are instructed to: 

o Within their fiscal year 2009 budget submissions, identify the 

budgetary resources needed to support the ACE/ITDS interface. 

Within 60 days, designate a senior executive responsible for 

implementing the ACE/ITDS interface. 

Participating Government Agencies (PGAs)

• AMS - Agricultural Marketing Service (Agriculture)* 

• APHIS - Animal and Plant Health Inspection Service (Agriculture)* 

• ATF - Bureau of Alcohol, Tobacco, Firearms and Explosives 

(Justice)* 

• BIS – Bureau of Industry and Security (Commerce) 

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ernational Trade Commission 

• BLS - Bureau of Labor Statistics (Labor) 

• BTS - Bureau of Transportation Statistics (Transportation) 

• CDC- Center for Disease Control (Health and Human Services)* 

• Census – U.S. Census Bureau (Commerce) 

• CPSC – Consumer Product Safety Commission* 

• DEA – Drug Enforcement Administration (Justice)* 

• EPA - Environmental Protection Agency* 

• FAA - Federal Aviation Administration (Transportation)* 

• FAS – Foreign Agricultural Services (Agriculture) 

• FCC - Federal Communications Commission* 

• FDA - Food and Drug Administration (Health and Human Services)* 

• FMC - Federal Maritime Commission 

• FMCSA - Federal Motor Carrier Safety Administration 

(Transportation)* 

• FSIS - Food Safety and Inspection Service (Agriculture)* 

• FTZB - Foreign Trade Zones Board (Commerce) 

• FWS - Fish and Wildlife Service (Interior)* 

• GIPSA – Grain Inspection, Packers and Stockyards Administration 

(Agriculture) 

• IA - International Trade Administration–Import Administration 

(Commerce) 

• IRS - Internal Revenue Service (Treasury) 

• ITC – Int

• MARAD - Maritime Administration (Transportation)

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• NHTSA – National Highway Traffic Safety Administration 

(Transportation)* 

• NMFS – National Oceanic Atmospheric Administration / National 

Marine Fisheries Service, Office for Law Enforcement (Commerce)* 

• NRC - Nuclear Regulatory Commission* 

• OFAC - Office of Foreign Assets Control (Treasury) 

• OFE – Office of Fossil Energy (Energy) 

• OFM - Office of Foreign Missions (State) 

• State – Logistics Management (State) 

• TTB - Alcohol and Tobacco Tax and Trade Bureau (Treasury)* 

• USACE - Army Corps of Engineers (Defense) 

*Agencies designated by the Board of ITDS as import safety agencies 

due to their roles in licensing, certifying, and permitting import 

shipments. 

3. Global Collaboration – Instruct agencies to develop and increase 

international cooperation and collaboration. 

The Department of State (State) has contacted host governments in 39 

countries that are top exporters of food and consumer products to the 

United States to seek information on how various countries handle 

import safety issues. In the coming weeks, State, the Office of the 

United States Trade Representative (USTR), and other interested 

agencies will analyze the responses to these inquiries and meet to 

determine appropriate next steps. 

As part of these next steps, State and USTR should coordinate with 

other Working Group members to determine whether appropriate 

international and regional organizations could be helpful in hosting 

international conferences or other actions to promote product safety, in 

order to generate high-level global attention to a worldwide problem. 

Such events could provide a forum to exchange information on effective 

product safety practices, identify opportunities for regulatory capacity 

building, and promote science-based regulation, consistent with U.S. law 

and our international obligations. 

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Recommendations for implementation of this action will be included in 

the Working Group’s forthcoming Action Plan. 

4. Agreements with Foreign Governments – Instruct agencies to 

catalog on-going and planned import safety-related agreements 

(bilateral and multilateral) with foreign governments. In addition, 

require agencies to meet within 45 days and then on a regular basis 

to discuss negotiations underway or that are anticipated and share 

lessons learned. 

Various U.S. government agencies work with foreign governments to 

conclude and implement bilateral and multilateral agreements to 

improve import safety. In many cases, the agency that has expertise in a 

particular facet of import safety takes the lead in the negotiations. The 

resulting agreements, however, may affect the jurisdiction, operations, 

and resources of other agencies. Therefore, coordination among all the 

relevant agencies is necessary to ensure that all such agreements are as 

effective as possible and can be fully implemented. 

Currently, coordination procedures vary depending on the nature of the 

agreement. Despite the various existing means for coordination, 

interagency work on import safety negotiations with foreign 

governments can be improved. In particular, efforts should be made to 

increase interagency awareness of agencies’ ongoing and planned 

discussions with foreign governments regarding import safety 

agreements. In addition, the current coordination processes should be 

modified to provide a forum for agencies to share successful strategies 

and approaches with other agencies that could benefit from their 

experiences. Earlier and improved coordination will help ensure that 

agreements fully benefit from relevant agencies’ experiences, avoid 

duplicative or counterproductive efforts, and generally improve the 

negotiating position of the U.S. government. 

To this end, as an immediate action, agencies should be required to 

catalog ongoing and planned discussions with foreign governments 

regarding import safety. Until the Action Plan is issued, the Department 

of Commerce should host regular advisory meetings for these agencies 

to share information about their efforts, experiences and concerns. This 

process is not a review and would in no way supplant or delay the TPSC 

and C-175 processes, or any other on-going relevant inter-agency 

process. International cooperation regarding law enforcement or other 

similar activities would not be subject to these meetings. 

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Appendix C: Recent Actions and Current Plans to 

Protect American Consumers 

As directed by the President, all departments and agencies have been reviewing 

and assessing current procedures, authorities, outreach efforts and international 

cooperation initiatives to enhance the safety of imported products. They have 

met with foreign governments, foreign manufacturers and others in the 

exporting country’s private-sector, as well as with producers, importers, 

retailers, trade associations, consumer groups and others in the U.S. importing 

community. 

Based on these reviews and meetings, the departments and agencies have 

already taken numerous actions to protect American consumers. Many more 

initiatives to enhance the safety of imported products are underway and will be 

completed in the coming months. This appendix summarizes significant recent 

accomplishments and important actions that will be completed within the first 

200 days of issuing this Action Plan. 

The actions are structured according to the organizing principles from the 

Strategic Framework and the recommendations included in this Action Plan. 

Prevention with Verification 

Safety Standards 

• Food Protection Plan. FDA has developed a Food Protection Plan that 

addresses both food safety and food defense for domestic and imported 

products, including food protection from production to consumption. 

The Plan will be phased in over the coming months and is integrated 

with the Administration’s Import Safety Strategic Framework and 

Action Plan. 

Certification 

• NOAA Seafood Inspection Program. As of October 24, 2007, the 

Department of Commerce’s National Oceanic and Atmospheric 

Administration (NOAA) Seafood Inspection Program had inspected and 

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certified seven seafood processing plants in China and has plans to 

inspect another 12 plants. There are a number of other plants in the 

queue to be inspected. 

• Improved Compliance with Toxic Substance Control Standards. 

EPA’s Office of Prevention, Pesticides and Toxic Substances has been 

developing a Toxic Substance Control Act (TSCA) “Section 13 Import 

Compliance Checklist” as a compliance assistance tool to help chemical 

importers and government inspectors better understand import 

certification requirements. When finalized, the Checklist will be posted 

on various Web sites and disseminated in other ways. 

• Seafood Inspectors Stationed in Other Asian Countries. NOAA is 

in the process of stationing an inspector full time in Hong Kong and has 

plans to put inspectors in other countries that export large volumes of 

seafood to the United States. 

• New Zealand Meat Certification. USDA’s Food Safety and 

Inspection Service (FSIS) began reprogramming its import inspection 

data system to enable an electronic data transfer of certifications for 

meat export shipments from New Zealand. This will constitute 

verification that importers have presented New Zealand import 

shipments for FSIS inspection as required by law. Full electronic 

certificate exchange capability is expected to be operational by the end 

of 2007 and will be extended to include Australia and Canada during 

2008. 

• Accreditation of Private Labs. FDA will issue guidance by mid 2008 

that would set standards for the sampling and testing of imported 

products, including the use of accredited private laboratories submitting 

data to FDA to assist in evaluating whether an appearance of a violation 

may be resolved. Increased confidence in the sampling techniques and 

methodologies used by accredited laboratories and in the data they 

submit may allow FDA to base decisions on abbreviated laboratory 

packages from accredited laboratories, expedite review of the 

information in those packages and facilitate admissibility decisions. 

Foreign Cooperation and Capacity Building 

• Safety Agreement with China on Toys, Fireworks and Electrical 

Products. Meetings held in September 2007 between CPSC and its 

counterpart, the General Administration of Quality Supervision, 

Inspection and Quarantine (AQSIQ) of the People’s Republic of China 

resulted in a renewed Memorandum of Understanding (MOU) related to 

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problem is detected with seafood being imported from China. Drafts 

ent is anticipated in early 2008. 

-

the promotion of safety for target products—children’s toys, fireworks, 

cigarette lighters and electrical products. 

• Memoranda of Agreements with China on Food, Drugs, Medical 

Devices and Animal Feed. HHS/FDA is negotiating binding 

agreements with the Chinese government to enhance regulatory 

cooperation in the area of drugs, medical devices, food and animal feed. 

These agreements will protect the safety and health of consumers and 

animals in the United States and in China. 

• Motor Vehicle Safety Agreement with China. On September 12, the 

Department of Transportation’s National Highway Traffic Safety 

Administration (NHTSA) signed a Memorandum of Cooperation with 

China aimed at increasing cooperation in the areas of motor vehicle 

regulation and safety. Both sides indicated a willingness to work 

together to address issues related to the safety of Chinese motor 

vehicles and equipment (including tires and automotive fuses) intended 

for export to the United States. 

• Tire Safety Standards Talks with China. From September 11 

through September 18, NHTSA staff with expertise in NHTSA’s tire 

standards and enforcement process attended the Chinese International 

Tire Exposition in Shanghai and met with China’s technical experts on 

tire issues in Hangzhou. At both locations, NHTSA representatives 

made detailed presentations on the agency’s standards and enforcement 

process. The presentations were well received by the many 

representatives of the Chinese tire industry who participated in these 

sessions. NHTSA’s delegation also obtained information that will be 

useful in designing strategies to help deter and detect the shipment of 

noncompliant or defective tires from China to this country. 

• Seafood Inspection Agreement with China. NOAA’s National 

Marine Fisheries Service (NMFS) has begun discussions with China’s 

Administration of Quality Supervision, Inspection and Quarantine 

(AQSIQ) on an MOU to improve information transfer and to increase 

the traceability of products. The MOU would establish a notification 

system whereby each party would alert the other in the event that a 

have been exchanged and a final agreem

• Foreign Training on United States Safety Standards for Meat, 

Poultry and Eggs. In July 2007, USDA and FDA conducted a seven

week training program for Chinese inspection officials. FSIS also 

conducted outreach to foreign government inspection officials regarding 

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FSIS import requirements for meat, poultry and egg products. FSIS 

provided technical assistance to the Austrian government regarding 

U.S. import requirements for ready-to-eat products, to Mexico 

regarding microbiological testing procedures and to the governments of 

Bosnia-Herzegovina, Namibia and Thailand about U.S. import 

requirements in general. 

• United States-Europe Consumer Protection Talks. On 

October 14, 2007, the Trans-Atlantic Consumer Dialogue was 

held at the State Department. Topics included the review of the 

respective regulatory impact assessment guidelines on trade and 

investment and their application, reduction in barriers on trade in 

chemicals, controlling hazardous toy and consumer product imports, 

recognition of Supplier’s Declaration of Conformity for electrical 

equipment and other topics of concern in the ongoing trans-Atlantic 

dialogue.

• Security and Prosperity Partnership (SPP) priority on Safe Food 

and Products. In August, President Bush, President Calderon of 

Mexico and Prime Minister Harper of Canada pledged to strengthen 

trilateral cooperation and mechanisms within the region, build on 

current standards and practices and work with our trading partners 

outside of North America to identify and stop unsafe food and products 

before they enter our countries. 

• Product Safety in Standards Dialogues. The Department of 

Commerce is engaging in standards dialogues with key trade partners 

like Brazil, the European Commission and India. Product safety issues 

were discussed with India on October 25 and with the European Union 

on October 29. These dialogues encourage information exchange on 

policies, procedures and processes to ensure the safety of imported 

products. 

• International Food Safety Standards Work in Codex Alimentarius. 

The Department of Commerce, State, EPA, USDA, FDA and USTR are 

actively engaged in international food safety standards development 

work in Codex Alimentarius. Codex already has a significant inventory 

of standards and guidelines that address food hygiene, food labeling, 

food import and export certification and inspection systems, 

contaminants in food and other areas. The United States is considering 

what gaps exist in food safety standards that Codex might address 

through new work activities. 

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• China Joint Commission on Commerce and Trade (JCCT) 

Pharmaceutical Task Force. The JCCT provides ongoing workshops 

to the Chinese government on anti-counterfeiting and manufacturing 

best practices for pharmaceuticals. Accomplishments have included 

direct input into the China State Food and Drug Administration’s 

update of its drug registration review process. 

• China Joint Commission on Commerce and Trade (JCCT) Medical 

Devices Task Force. The Department of Commerce and FDA provide 

ongoing training to the Chinese government on the use of quality 

systems to ensure the safety of manufactured products, including 

conducting product recalls for medical devices. 

• Pharmaceutical anti-counterfeiting activity under the United 

States-India High Technology Cooperation Group's Biotechnology 

& Life Sciences Working Group. This group organizes activities to 

fight the counterfeiting of pharmaceuticals and addresses the regulation 

of active pharmaceutical ingredients to prevent the production of 

counterfeit medicines. In August 2007, this group discussed with 

Indian government officials the need to cooperate with the international 

community in stopping the production and export of counterfeit 

pharmaceuticals and the need to regulate active pharmaceutical 

ingredients. 

• APEC Anti-Counterfeit and Regulatory Harmonization Seminars 

on Medical Devices. DOC and FDA are organizing a series of 

capacity-building seminars for Asia and Latin America focused on 

stopping the spread of counterfeit health products and promoting 

regulatory harmonization for medical devices. The first anti-counterfeit 

seminar will take place in Singapore in January 2008; the first 

regulatory harmonization seminar will take place in Kuala Lumpur in 

March 2008. Subsequent seminars will take place throughout 2008 and 

early 2009 in Asia and Latin America. Participants will include: 

pharmaceutical and medical device regulators, custom and law 

enforcement officials, health professionals and industry representatives. 

• Motor Vehicle Safety Seminars with Chinese Companies. In late 

2007 or early 2008, NHTSA plans to send senior officials to China to 

meet with the relevant government departments and agencies, trade 

associations and companies to discuss how NHTSA’s standards and 

enforcement process apply to exports intended for sale in the United 

States. NHTSA intends to reach those companies already engaged in 

exporting motor vehicle equipment and those that have announced plans 

to export motor vehicles to the United States in the next two years. 

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NHTSA will also look for opportunities to enter into more detailed 

agreements with the Chinese government on cooperative methods to 

help ensure that imports are compliant with NHTSA standards. 

• Cooperative Agreement with China on Environmental 

Requirements. In April 2007, EPA met with China’s AQSIQ and 

other groups and agreed to draft an EPA-AQSIQ MOU to exchange 

information on environmental requirements and cooperate to help 

ensure compliance. 

• Cooperation on Enforcement of Environmental Laws in North 

America. An understanding was recently reached among EPA, 

Canadian and Mexican environmental law enforcement officials to 

share information about noncompliant imports entering the borders of 

any of the countries. 

• North American Development of Enforcement Training to Ensure 

Legal Imports. In September 2007, representatives from 

environmental agencies of the United States, Canada and Mexico, 

reviewed an electronic training module on ozone-depleting substances. 

At the same time, the officials approved the creation of a similar 

module for hazardous waste. 

• Outreach on Import Safety through Diplomatic Channels. The 

State Department’s Bureaus of Economic, Energy and Business Affairs 

and International Information Programs developed an outreach plan to 

reach foreign audiences on import safety. To date, import safety 

articles have already been published in international newspapers; more 

are expected over the near term. In August 2007, the Department of 

State sent cables to all overseas posts to provide them with information 

about import safety and the role of the Interagency Working Group on 

Import Safety for discussion with governments and the private-sector. 

• Negotiation and Capacity Building through Trade Channels. An 

integral part of U.S. free trade agreements are commitments to address 

sanitary and phytosanitary (SPS)12 issues. In the past year, USTR 

concluded free trade agreements with Peru, Colombia, Panama and 

Korea, each of which includes a specific SPS chapter that has as a 

principal objective the protection of human and animal health. In 

particular, the SPS chapters provide for the establishment of a standing 

committee of the parties to enhance cooperation and consultation on 

SPS matters and improve understanding of each other’s SPS 

 12 An SPS measure is generally any measure applied to protect human, animal or plant life or 

health from risks arising from pests, diseases or adulterants or contaminants in food or feed. 

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requirements. These agreements also provide for capacity building and 

technical assistance in SPS activities. 

• Anti-Counterfeiting Trade Agreement. On October 23, 2007, USTR 

announced that the United States and some of its key trading partners 

will seek to negotiate an Anti-Counterfeiting Trade Agreement. Anticounterfeiting efforts will help to improve the safety of imported 

products 

• International Dialogues. The Department of State, Department of 

Commerce, USDA, USTR, HHS and other federal departments and 

agencies are encouraging the inclusion of import safety in regional and 

international dialogues. 

o Import safety will be discussed at the United States-European 

Union High Level Regulatory Cooperation Forum in November 

and may also be taken up by the Transatlantic Economic 

Council, which is also meeting in November. 

o At the Asia-Pacific Economic Cooperation (APEC) Summit in 

September, leaders agreed “to develop initiatives in the coming 

year that effectively address problems related to import safety in 

ways that do not hinder trade.” There are a number of specific 

project proposals underway, including one by China to promote 

information sharing to improve “food safety systems” and 

another to address Hazard Analysis and Critical Control Points 

(HACCP). 

o USDA has indicated it will fund food safety related workshops 

for APEC. The primary goal of these workshops would be to 

raise awareness of, engagement in and compliance with 

international food safety standards-setting bodies, such as Codex 

Alimentarius, World Organization for Animal Health (OIE) and 

the International Plant Protection Convention. 

o The Association of Southeast Asian Nations (ASEAN) has 

endorsed creating a Coordinating Committee on Consumer 

Protection at its August meeting and is in communication with 

officials at the CPSC, USDA, FDA and the Federal Trade 

Commission. 

Intervention 

Common Mission 

• Enhanced Interagency Cooperation on Animal and Plant 

Inspections. USDA’s FSIS and USDA’s Animal and Plant Health 

Inspection Service (APHIS) continued monthly conference calls to 

discuss key import and export issues of concern and to resolve technical 

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 Stockyards Administration began the ITDS process with 

• us 

ent 

problems between the agencies. Recently, participation was expanded 

to include representatives from the Food and Drug Administration and 

U.S. Customs and Border Protection. 

• Enhanced Cooperation on Egg Product Safety. USDA agencies 

(FSIS, AMS and APHIS) coordinated potential product code systems in 

use by FDA and the Global Safety Initiative that might further identify 

USDA-regulated animal, egg and plant products in ITDS/ACE. The 

agencies currently responsible for regulating the import of eggs and egg 

products—FDA, APHIS, FSIS, CBP and AMS—are currently 

identifying product codes to provide clarity in classifying imported 

products under the Harmonized Tariff Codes. 

• Cooperation on Counterfeits. DOC’s International Trade 

Administration (ITA) Office of Intellectual Property Rights is 

collaborating with CPSC to create a Counterfeit Alert System that would 

refer reports of counterfeits received by CPSC’s hotline to DOC’s Stop 

Fakes hotline. 

Interoperability 

• Public Health Information System. On September 27, the Food Safety 

and Inspection Service (FSIS) awarded a contract for development of a 

new corporate data warehouse called the Public Health Information 

System, which will support a user interface for imports and exports. 

FSIS will develop, test and launch the system. This includes 

establishing an electronic connection with CBP’s ACE/ITDS system and 

importers for processing imported meat, poultry and egg product 

shipments. 

• USDA Harmonization with Trade Data System. USDA’s 

Agricultural Marketing Service (AMS) and APHIS made important 

progress in establishing an interface with ACE/ITDS. AMS completed 

import-related business processes, drafted a Concept of Operations and 

Memorandum of Understanding with CBP and engaged a contractor to 

identify areas where its connection with ACE/ITDS can be optimized. 

APHIS submitted its Concept of Operations and Memorandum of 

Understanding to CPB on October 10. USDA’s Grain Inspection, 

Packers and

CBP on October 30, 2007. 

EPA Harmonization with Trade Data System. Building on previo

work with CBP and other relevant federal agencies on the developm

of the single window import-export data system, EPA has accelerated 

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steps in order to become interoperable with ACE/ITDS. EPA is 

developing business processes and requirements to exchange data 

between six EPA programs and ACE/ITDS. EPA identified the Chief 

Information Officer as the executive level representative; assigned 

EPA’s internal Exchange Network Subcommittee as the governance 

body; established a project management/implementation team structure; 

is preparing a project implementation plan for submission to OMB on 

November 12, 2007 and is revising a concept of operations document for 

submission to CBP in December 2007. EPA is leveraging the Central 

Data Exchange and Exchange Network technology which the Agency 

currently uses to exchange data with all 50 states and seven Indian 

Tribes. 

Response 

Vigorous Enforcement of Safety Statutes 

• Marking Rule to Prevent Port-Shopping. By mid-2008, FDA will 

issue a proposed rule that would require imported food that has been 

refused entry to be marked “United States: Refused Entry”. Such 

marking would help prevent the introduction of unsafe food into the 

United States through port shopping, a practice whereby importers 

attempt to gain entry through a port after the goods have been refused at 

another. 

• Criminal Prosecution of Counterfeit Drug and Illegal Substance 

Offenders. FDA, CBP and DOJ are continuing vigorous enforcement 

of statutes banning trade in counterfeit and illegal products. For 

example, DOJ recently prosecuted an Ohio man charged in online 

pharmacy conspiracy for selling counterfeit drugs (Viagra, Cyalis, 

Levitra) shipped from such countries as Pakistan, India and Great 

Britain. The agencies also collaborated in an international law 

enforcement operation targeting the underground manufacture of 

anabolic steroids. The operations have led to 124 arrests nationwide to 

date and the dismantling of approximately 100 illegal sites that aided in 

the manufacture and distribution of anabolic steroids, prescription 

medicines, counterfeit drugs and chemical precursors originating from 

approximately 30 rogue laboratories in China.

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Appendix D: List of Acronyms and Abbreviations 

Acronyms 

ACE Automated Commercial Environment 

AMS Agricultural Marketing Service 

APEC Asia-Pacific Economic Cooperation 

APHIS Animal and Plant Health Inspection Service 

AQSIQ Administration of Quality Supervision, Inspection and 

Quarantine 

ASEAN Association of Southeast Asian Nations 

ASISA Aviation Safety Information Sharing and Analysis 

TS A Automated Targeting System 

COAC Commercial Operations Advisory Committee 

CBP Customs and Border Protection 

CPSA Consumer Product Safety Act 

CPSC Consumer Product Safety Commission 

C-TPAT Customs Trade Partnership Against Terrorism 

DHS Department of Homeland Security 

DOC Department of Commerce 

DOJ Department of Justice 

DOT Department of Transportation 

eLEXNET Electronic Laboratory Exchange Network 

EOP Executive Office of the President 

EPA Environmental Protection Agency 

EPIA Egg Products Inspection Agency 

FAA Federal Aviation Administration 

FDA Food and Drug Administration 

FDCA Federal Food, Drug and Cosmetics Act 

FERN Food Emergency Response Network 

FMIA Federal Meat Inspection Act 

FSIS Food Safety and Inspection Service 

GIDEP Government Industry Data Exchange Program 

GMA Grocery Manufacturers Association 

GSI Global Safety Initiative 

HACCP Hazard Analysis and Critical Control Points 

HHS Department of Health and Human Services 

HTS Harmonized Tariff Schedule 

ICAO International Civil Aviation Organization 

IIP International Information Programs 

IMDG International Maritime Dangerous Goods 

IMO International Maritime Organization 

IPR Intellectual Property Rights 

ITA International Trade Administration 

ITDS International Trade Data System 

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MOU Memorandum of Understanding 

NHTSA National Highway Traffic Safety Administration 

NMFS National Marine Fisheries Service 

NOAA National Oceanic and Atmospheric Administration 

NTC National Targeting Center 

OASIS Operational and Administrative System for Import 

Support 

OMB Office of Management and Budget 

 PHMSA Pipeline and Hazardous Materials Safety Administrati

PPIA Poultry Products Inspection Act 

RFID Radio Frequency Identification 

rt SAFE Po Safety and Accountability for Every Port Act 

SCC Food and Agriculture Sector Coordinating Council 

SDS Standard Data Set 

 SEDS Standard Establishment Data Service 

SFDA China State Food and Drug Administration 

SIP Seafood Inspection Program 

SPP Security and Prosperity Partnership 

State Department of State 

STOP Strategy Targeting Organized Piracy 

TACD Trans-Atlantic Consumer Dialogue 

TIA U.S. Toy Industry of America 

Treasury Department of Treasury 

 TSCA Toxic Substance Control Act 

USDA Department of Agriculture 

USPTO U.S. Patent and Trademark Office 

USTR U.S. Trade Representative 

nWorki g Group Interagency Working Group on Import Safety 

on

78
Action Plan for Import Safety: A roadmap for continual improvement 

www.importsafety.gov 

uinn Dodd, Chief of Staff, Consumer Product Safety Commission 

Appendix E: Working Group Designees and Staff 

Interagency Working Group on Import Safety Designees 

Secretary Michael O. Leavitt, Department of Health and Human Services, Chair 

of the Interagency Working Group 

Andrew von Eschenbach, Commissioner of Food and Drug Administration, 

Department of Health and Human Services 

Dan Sullivan, Assistant Secretary for Economic, Energy and Business Affairs, 

Department of State 

Alan Holmer, Special Envoy for China and the Strategic Economic Dialogue, 

Department of Treasury 

John O’Quinn, Deputy Associate Attorney General, Department of Justice 

Richard Raymond, Under Secretary for Food Safety, Department of Agriculture 

David Spooner, Assistant Secretary for Import Administration, Department of 

Commerce 

Jeff Shane, Under Secretary for Policy, Department of Transportation 

Jeff Runge, Assistant Secretary for Health, Department of Homeland Security 

Robert Shea, Associate Director for Management, Office of Management and 

Budget 

Warren Maruyama, General Counsel, U.S. Trade Representative 

Jim Gulliford, Assistant Administrator for Prevention, Pesticides and Toxic 

Substances, Environmental Protection Agency 

Q

79
Action Plan for Import Safety: A roadmap for continual improvement 

www.importsafety.gov 

Interagency Working Group on Import Safety Staff 

Jerry Regier, Executive Secretary for the Working Group, Department of Health 

and Human Services 

Jeff Shuren, Food and Drug Administration 

Cathy Sauceda, Department of Homeland Security 

John Menard, Department of State 

Bob Tuverson, Department of Agriculture 

Karen Stuck, Department of Agriculture 

Stephen Claeys, Department of Commerce 

Bernard Carreau, Department of Commerce 

Randy Pate, Department of Health and Human Services 

Rob Raffety, Consumer Product Safety Commission 

Celesia Gouhari, Department of Health and Human Services 

Natalie Gochnour, Department of Health and Human Services 

Erik Mettler, Food and Drug Administration 

80
No import safety system can succeed without 

collaboration from everyone involved. We share a 

common interest in import safety and this Action Plan will 

guide our collective actions moving forward. 

Secretary Michael O. Leavitt 

Chair, Interagency Working Group on Import Safety 
4 

www.importsafety.gov