Consumer Product Safety Commission Issues [1 ed.] 9781613242735, 9781608767663

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Copyright © 2010. Nova Science Publishers, Incorporated. All rights reserved. Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

Copyright © 2010. Nova Science Publishers, Incorporated. All rights reserved. Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

SAFETY AND RISK IN SOCIETY

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CONSUMER PRODUCT SAFETY COMMISSION ISSUES

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SAFETY AND RISK IN SOCIETY Chemical Safety Board Robert W. Talford (Editor) 2009. ISBN: 978-1-60692-586-7

Copyright © 2010. Nova Science Publishers, Incorporated. All rights reserved.

Consumer Product Safety Issues Péter A. Varga and Máté D. Pintér (Editors) 2009. ISBN: 978-1-60456-826-4

Risk Management Benigno Jordão and Emilio Sousa (Editors) 2010. ISBN: 978-1-60876-011-4 Consumer Product Safety Commission Issues Isaac E. Bowman (Editor) 2010. ISBN: 978-1-60876-766-3

Fire Safety Ingmar Søgaard and Hans Krogh (Editors) 2009. ISBN: 978-1-60741-490-2

A Look at School Crime Safety Maegan E. Hauserman (Editor) 2010. ISBN: 978-1-61668-773-1

Accidents: Causes, Analysis and Prevention Henri Bédard and Geraud Delashmit (Editors) 2009. ISBN 978-1-60741-712-5 2009. ISBN: 978-1-61668-510-2 (E-book)

Rehab, Protection and Safety Measures for Firefighters and Emergency Responders Andreo Rios 2010. ISBN: 978-1-60741-566-4 2010. ISBN: 978-1-61728-051-1 (E-book)

Protective Devices: Types, Uses and Safety Victor E. Argosyan (Editor) 2010. ISBN: 978-1-60876-223-1

Fire In The United States: A Reference Work on the Nation's Fire Problem Ciro Bouchard and Marco Fortin (Editors) 2010. ISBN: 978-1-60741-746-0

Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

SAFETY AND RISK IN SOCIETY

CONSUMER PRODUCT SAFETY COMMISSION ISSUES

ISAAC E. BOWMAN

Copyright © 2010. Nova Science Publishers, Incorporated. All rights reserved.

EDITOR

Nova Science Publishers, Inc. New York

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Copyright © 2010 by Nova Science Publishers, Inc. All rights reserved. No part of this book may be reproduced, stored in a retrieval system or transmitted in any form or by any means: electronic, electrostatic, magnetic, tape, mechanical photocopying, recording or otherwise without the written permission of the Publisher. For permission to use material from this book please contact us: Telephone 631-231-7269; Fax 631-231-8175 Web Site: http://www.novapublishers.com

NOTICE TO THE READER The Publisher has taken reasonable care in the preparation of this book, but makes no expressed or implied warranty of any kind and assumes no responsibility for any errors or omissions. No liability is assumed for incidental or consequential damages in connection with or arising out of information contained in this book. The Publisher shall not be liable for any special, consequential, or exemplary damages resulting, in whole or in part, from the readers‘ use of, or reliance upon, this material. Any parts of this book based on government reports are so indicated and copyright is claimed for those parts to the extent applicable to compilations of such works.

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Independent verification should be sought for any data, advice or recommendations contained in this book. In addition, no responsibility is assumed by the publisher for any injury and/or damage to persons or property arising from any methods, products, instructions, ideas or otherwise contained in this publication. This publication is designed to provide accurate and authoritative information with regard to the subject matter covered herein. It is sold with the clear understanding that the Publisher is not engaged in rendering legal or any other professional services. If legal or any other expert assistance is required, the services of a competent person should be sought. FROM A DECLARATION OF PARTICIPANTS JOINTLY ADOPTED BY A COMMITTEE OF THE AMERICAN BAR ASSOCIATION AND A COMMITTEE OF PUBLISHERS. LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA Consumer Product Safety Commission issues / editors, Isaac E. Bowman. p. cm. Includes index. ISBN HERRN 1. Product safety--United States. 2. U.S. Consumer Product Safety Commission. I. Bowman, Isaac E. TS175.C653 2009 381.3'40973--dc22 2009045952

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CONTENTS Preface

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Chapter 1

vii Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported Products Government Accountability Office

Chapter 2

Consumer Product Safety Commission: CPSIA Implementation Bruce K. Mulock

Chapter 3

Better Data Collection and Assessment of Consumer Information Efforts Could Help Protect Minority Children Government Accountability Office

Chapter 4

Consumer Product Safety Improvement Act of 2008: P.L.110-314 Margaret Mikyung Lee

Chapter 5

Consumer Product Safety Improvement Act (CPSIA): New Requirements and Emerging Implementation Issues Margaret Mikyung Lee

1 69

85 109

145

Chapter Sources

163

Index

165

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PREFACE Public alarm about the spate of recent product recalls, particularly of toys and other products used by children, has focused attention on the Consumer Product Safety Commission (CPSC). This book provides an overview of the prior authority of the CPSC to establish consumer product safety standards and to inspect and recall unsafe consumer products. This book also describes the new requirements for certification and testing and the effect of the stay of enforcement of these requirements announced by the CPSC, certain new safety standards established by the CPSIA and related implementation actions and issues. In addition, author assessed injury and death data sources used by CPSC, compared CPSC's consumer education efforts with key practices, and interviewed federal officials and groups representing the health and consumer interests of minority populations. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access. Chapter 1 - The growing volume of consumer products imported into the United States has strained the resources of the Consumer Product Safety Commission (CPSC), challenging the agency to find new ways to ensure the safety of these products. The Consumer Product Safety Improvement Act (CPSIA) mandated that GAO assess the effectiveness of CPSC‘s authorities over imported products. GAO‘s objectives were to (1) determine what is known about CPSC‘s effectiveness in using these authorities, (2) compare CPSC‘s authorities with those of selected U.S. agencies and international entities, and (3) evaluate CPSC‘s plans to prevent the entry of unsafe consumer products. To address these objectives, GAO analyzed CPSC and other agencies‘ and entities‘ authorities, reviewed literature on consumer product safety, and compared CPSC‘s planning efforts with criteria for effective planning practices. Chapter 2- Created in the early 1970s, the Consumer Product Safety Commission (CPSC) is a small agency by Washington standards (less than 500 employees and a $80 million FY2008 appropriation) charged with a seemingly overwhelming responsibility: to protect American consumers against death or injury from unsafe products, including imported products. A series of high-profile product recalls during 2007—most notably of children‘s toys imported from China—focused attention on the CPSC‘s resources, including its legal authority, for the task at hand. In the 110th Congress, legislation (H.R. 4040 and S. 2663) to strengthen the Commission was considered, a conference agreement (H.Rept. 110-787) passed by both chambers, and Consumer Product Safety Improvement Act (CPSIA/P.L. 1103 14) was signed into law by President George W. Bush on August 14, 2008.

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Isaac E. Bowman

In the coming years it is widely anticipated by those who drafted the CPSIA, by the CPSC itself, and by those who follow or have a stake in consumer product safety, that the new law will prove to be a turning point in the agency‘s history – one which significantly empowered the CPSC to better protect consumers against defective and unsafe products. Over the next several years, many of the more than three dozen provisions included in the CPSIA will be put to the test, not the least of which are restoring the original five-member Commission leadership approach, following the experiment begun in 1982 of reducing the number of Commissioners to three; empowering the 50 state attorneys general to enforce CPSC‘s regulations; and requiring the agency to provide consumers with a user-friendly database on deaths and serious injuries caused by consumer products. For the moment, however, one thing seems certain: implementation of the CPSIA is not going well. The CPSC has been overwhelmed with multiple statutory deadlines. Confusion is rampant among manufacturers, importers, distributors, retailers, and consumers about new lead limits for consumer products intended for children 12 and under. Turmoil is particularly acute among small businesses. Despite agency efforts to provide clarification, consignment shops, thrift stores, and various charitable organizations still fear incurring stiff fines for inadvertently violating the CPSIA, and retailers across the county are contemplating disposing of valuable inventory that may well pose no health risks. A coalition of trade associations, including the National Association of Manufacturers, petitioned the CPSC to delay a February 10, 2009 effective date and issue guidance to businesses about complying with CPSIA. While Acting Chairman Nancy Nord said she ―agree[d] that the effective date of this provision is problematic for many, the Consumer Product Safety Commission does not have the authority to stay the effective date. Any such change must be made by Congress.‖ Nevertheless, on January 30, the CPSC Commissioners did vote to provide ―limited relief‖ from enforcement of testing and certifications for one year for manufacturers and importers of regulated products, including products intended for children 12 years old and younger. The agency also issued on February 10 a revised guidance document that explains to small businesses, resellers, crafters, and charities their responsibilities under the CPSIA. House and Senate committee and subcommittee chairmen have exchanged correspondence with the two-person CPSC Commission about how best to resolve numerous compliance and enforcement questions and several bills have been introduced to deal with various issues. Chapter 3 - In 2004, the U.S. Consumer Product Safety Commission (CPSC) estimated that 29,400 deaths in the United States were related to consumer products. As required under Section 107 of the Consumer Product Safety Improvement Act of 2008, this study reviews what is known about the relative incidence of preventable injuries and deaths among minority children associated with products intended for children's use and also examines what actions CPSC has taken through its public information and education initiatives to minimize these injuries and deaths. To address these issues, the authors assessed injury and death data sources used by CPSC, compared CPSC‘s consumer education efforts with key practices, and interviewed federal officials and groups representing the health and consumer interests of minority populations. Chapter 4 - Public alarm about the spate of recent product recalls throughout 2007, particularly of toys and other products used by children, has focused attention on the Consumer Product Safety Commission (the CPSC or the Commission). This scrutiny led to

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Preface

ix

consideration of major amendments to the Consumer Product Safety Act (CPSA), which established and authorized the CPSC in 1972 in response to growing concerns about protecting the public from unsafe, defective consumer products. Jurisdiction over the administration and enforcement of several existing consumer safety statutes was transferred from other agencies to and consolidated under the CPSC. However, in the years since its establishment, the staff and resources of the CPSC have been considerably reduced, leading many observers to doubt its ability to fulfill its mission effectively. Consequently, Congress considered major reform legislation to address organizational and systemic deficiencies. Legislative proposals in the 110th Congress included provisions targeting specific consumer product defects and hazards. On July 29, 2008, H.Rept. 110-787, the Conference Report for H.R. 4040, the Consumer Product Safety Improvement Act of 2008 (CPSIA), was released after several months of negotiations in the conference committee to reconcile differences between the House and Senate versions of the bill. The bill passed the House of Representatives and the Senate on July 30, 2008 (424-1) and July 31, 2008 (89-3), respectively. On August 14, 2008, President Bush signed the bill into law as P.L. 110-314. CPSC Chairman Nord and Commissioner Moore each expressed approval of the final legislation, with Chairman Nord expressing a desire for Congress to appropriate further funding to carry out the new mandates of the legislation. This report provides an overview of the prior authority of the CPSC to establish consumer product safety standards and to inspect and recall unsafe consumer products, and discusses P.L. 110-314, the Consumer Product Safety Improvement Act of 2008, reforming the CPSC and strengthening enforcement of consumer product safety standards. It supersedes CRS Report RL34399, Consumer Product Safety Improvement Act of 2008: H.R. 4040, by Margaret Mikyung Lee (out of print but available from author). For an overview and context of the current issues facing the Commission, see CRS Report RS2282 1, Consumer Product Safety Commission: Current Issues, by Bruce K. Mulock. For an overview of issues regarding safety of consumer products imported from China, see CRS Report RS22713, Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview, by Wayne M. Morrison. For an overview of the issue of phthalates in children‘s products, see CRS Report RL34572, Phthalates in Plastics and Possible Human Health Effects, by Linda-Jo Schierow and Margaret Mikyung Lee. Chapter 5 - This chapter will present an overview of issues regarding the implementation of the Consumer Product Safety Improvement Act of 2008 (CPSIA). In addition to strengthening the regulatory and enforcement authority of the Consumer Product Safety Commission, the new law established new safety standards, such as those for lead content and phthalates, and testing and certification requirements, focusing particularly on children‘s products. A range of implementation issues have arisen, including uncertainty about possible exemptions to and appropriate compliance with new standards, compliance with testing and certification requirements, disputes about Commission interpretation of new standards, and the particular concerns of small businesses and of non-profit resellers. For additional information on implementation issues, see CRS Report RS22821, Consumer Product Safety Commission: CPSIA Implementation, by Bruce K. Mulock. For a summary of the provisions in the CPSIA, including those not described in this report, see CRS Report RL34684, Consumer Product Safety Improvement Act of 2008: P.L. 110-314, by Margaret Mikyung Lee.

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Chapter 1

BETTER INFORMATION AND PLANNING WOULD STRENGTHEN CPSC’S OVERSIGHT OF IMPORTED PRODUCTS Government Accountability Office

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WHY GAO DID THIS STUDY The growing volume of consumer products imported into the United States has strained the resources of the Consumer Product Safety Commission (CPSC), challenging the agency to find new ways to ensure the safety of these products. The Consumer Product Safety Improvement Act (CPSIA) mandated that GAO assess the effectiveness of CPSC‘s authorities over imported products. GAO‘s objectives were to (1) determine what is known about CPSC‘s effectiveness in using these authorities, (2) compare CPSC‘s authorities with those of selected U.S. agencies and international entities, and (3) evaluate CPSC‘s plans to prevent the entry of unsafe consumer products. To address these objectives, GAO analyzed CPSC and other agencies‘ and entities‘ authorities, reviewed literature on consumer product safety, and compared CPSC‘s planning efforts with criteria for effective planning practices.

WHAT GAO RECOMMENDS GAO recommends that CPSC (1) ensure expeditious implementation of key CPSIA provisions; (2) take several actions to strengthen its ability to target shipments of unsafe consumer products, such as resolving issues with CBP for obtaining more data on incoming shipments; and (3) develop a long-term plan for ensuring the safety of consumer products entering the United States, including long-term plans for international engagement. CPSC agreed with these recommendations. View GAO-09-803 or key components.

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WHAT GAO FOUND GAO found broad consensus that CPSC‘s authorities over imported consumer products have the potential to be effective. However, CPSC has made limited progress in measuring the effectiveness of its authorities, and CPSC‘s ability to implement these authorities has been constrained by competing priorities and limited resources, as well as by delays in implementing key provisions of CPSIA. CPSC‘s presence at U.S. ports is limited and, in order to identify potentially unsafe products, it must work closely with U.S. Customs and Border Protection (CBP), which faces pressure to quickly move shipments into commerce. CPSC does not have access to key CBP import data it could use to target incoming shipments for inspection, and it has not updated its agreements with CBP to clarify each agency‘s roles and responsibilities. CPSC‘s activities at U.S. ports could be strengthened by better targeting incoming shipments for inspection and by improving CPSC‘s coordination with CBP. Otherwise, CPSC may not be able to carry out key inspection activities efficiently or to effectively leverage its enforcement priorities with CBP. Select federal agencies and foreign governments provide lessons for strengthening CPSC‘s implementation of its authorities, particularly with respect to border surveillance and information sharing among countries. Both USDA and FDA have more robust border surveillance activities than CPSC because they obtain more data on incoming shipments, have more staff working at U.S. ports, use more developed programs to target risks, and use information technology systems that are integrated with other agency-based and CBP systems to effectively leverage their enforcement priorities with CBP. Other agencies have found that timely CBP import data integrated with other agency surveillance data is useful in screening incoming shipments for potential safety violations. In addition, officials at FDA and USDA have found that efforts to educate overseas industries and governments on U.S. safety standards could reduce the number of unsafe products that reach U.S. consumers. GAO also found broad consensus that continued coordination and information sharing among governments and multilateral organizations can improve the effectiveness of product safety frameworks. CPSC has increased its efforts to coordinate with these other entities, particularly China, but lacks a comprehensive plan for international engagement. CPSC has established annual plans, but lacks a long-term plan with key goals to prevent the entry of unsafe products. CPSC has not yet updated its agencywide Strategic Plan to reflect new authorities granted in CPSIA. This may inhibit CPSC‘s ability to appropriately allocate any potential increases in agency resources or to address the safety of imported products through international means. An updated Strategic Plan may also help to ensure that CPSC has the requisite compliance and analytical staff to support the full range of CPSC‘s international efforts.

ABBREVIATIONS ACCC AIIS APEC APHIS

Australian Competition and Consumer Commission Automated Import Information System Asian-Pacific Economic Cooperation Animal and Plant Health Inspection Service

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… AQSIQ

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CBP CCC CEN CENELEC CIQ CNCA CPSC CPSIA DG SANCO ETSI EC EU FDA FSIS GPSD ICPHSO ITDS METI MOU NHTSA OASIS OECD PHIS PREDICT USDA USTR WTO

3

General Administration for Quality Supervision, Inspection, and Quarantine Customs and Border Protection China Compulsory Certification European Committee for Standardization European Committee for Electrotechnical Standardization Customs, Inspection and Quarantine Certification and Accreditation Administration of China Consumer Product Safety Commission Consumer Product Safety Improvement Act Directorate General for Health and Consumers European Telecommunications Standards Institute European Commission European Union Food and Drug Administration Food Safety and Inspection Service General Product Safety Directive International Consumer Product Health and Safety Organization International Trade Data System Ministry of Economy, Trade, and Industry (Japan) memorandum of understanding National Highway Traffic Safety Administration Operational and Administrative System for Import Support Organization for Economic Cooperation and Development Public Health Information System Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting U.S. Department of Agriculture Office of the United States Trade Representative World Trade Organization

August 14, 2009 The Honorable John D. Rockefeller IV Chairman The Honorable Kay Bailey Hutchison Ranking Member Committee on Commerce, Science, and Transportation United States Senate The Honorable Henry A. Waxman Chairman The Honorable Joe Barton Ranking Member Committee on Energy and Commerce House of Representatives

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The growing volume of consumer products—such as toys, household appliances, and children‘s apparel—imported into the United States has strained the resources of the Consumer Product Safety Commission (CPSC) and is challenging the agency to find new ways to ensure the safety of these products. From 1998 to 2007, the value of consumer products imported into the United States increased about 101 percent, with products from China (which includes Hong Kong) nearly quadrupling over that same period to constitute about 42 percent of all imported consumer goods. In addition to the growing value of imports, the number and variety of consumer products have been increasing. Consumer products are becoming more technically complex and sophisticated, and they increasingly are not ―from‖ any one place but rather consist of parts and components from any number of countries. Increasing imports of consumer products gained national attention in 2007. During that year, CPSC announced 473 recalls, the most in 10 years, and 389 of the recalls (or about 82 percent) involved products imported into the country. As a result, 2007 became known to some as ―the year of the recall.‖ The number of product recalls in fiscal year 2008 was even higher. These record numbers of recalls have raised the issue of whether CPSC can ensure the safety of products that are increasingly manufactured overseas. While the number of consumer products imported into the United States has been increasing, CPSC has become progressively smaller in terms of staff and resources. The commission has not had a full slate of five commissioners since 1986 and has not been authorized to fund more than three commissioner positions since 1993. In fiscal year 2008, CPSC had 396 full-time employees, compared with 480 full-time employees in fiscal year 1997. CPSC‘s fiscal year 2008 appropriation totaled about $80 million, and CPSC‘s fiscal year 2009 appropriation was not passed until March 2009— about 6 months into the fiscal year 2008—due to a congressional continuing budget resolution. In response to the high-profile recalls of imported products in 2007, as well as concerns that CPSC was inadequately staffed and funded to enforce existing product safety laws, Congress passed the Consumer Product Safety Improvement Act (CPSIA), which became law on August 14, 2008.1 CPSIA was intended to update and strengthen CPSC by authorizing expanded funding, mandating increased staffing subject to available appropriations, and enhancing existing CPSC authorities, including those regarding product safety standards, recalls, reporting, and administrative penalties. In addition, CPSIA introduced several new statutory tools to address the safety of imported products. Because Congress was concerned that there may be remaining gaps in U.S. product safety law or unforeseen consequences of CPSIA with respect to imported products, CPSIA mandated GAO to review a range of issues regarding CPSC‘s authorities to prevent the entry of unsafe products into the United States.2 Because CPSIA was recently passed, and CPSC has not had time to implement it fully, we responded to the mandate by (1) determining how CPSC assesses the effectiveness of its authorities in preventing the entry of unsafe consumer products and determining what is known about CPSC‘s effectiveness in using these authorities, (2) comparing certain aspects of CPSC‘s authorities with those of selected U.S. agencies, (3) comparing CPSC‘s authorities with those of selected international entities, and (4) evaluating CPSC‘s plans to prevent the entry of unsafe consumer products in the future. To determine the effectiveness of CPSC‘s import safety authorities, we examined CPSC data and interviewed CPSC officials to learn how the agency measures and assesses its own effectiveness. We conducted extensive document reviews on consumer product safety generally and import safety specifically. We interviewed legal professionals and consumer

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and industry representatives to obtain their perspectives on the effectiveness of CPSC‘s authorities. We also interviewed officials from other federal agencies involved in product safety at the international level, including U.S. Customs and Border Protection (CBP), the Office of the United States Trade Representative (USTR), and the Departments of State and Commerce. We visited a U.S. port of entry to observe CPSC import surveillance activities and CPSC‘s interaction with CBP staff at the port. We also visited CPSC‘s Product Testing Laboratory in Gaithersburg, Maryland, to observe laboratory testing that supports import safety activities. Furthermore, we conducted a comparative analysis of CPSC‘s authorities to prevent the entry of unsafe consumer products to similar authorities of selected U.S. federal agencies and selected countries. For our comparative analysis of U.S. federal agencies, we selected agencies that regulate the safety of products used by consumers and that possess recent, relevant experience with import safety. Specifically, we selected the U.S. Department of Agriculture (USDA), the Department of Health and Human Services‘ Food and Drug Administration (FDA), and the Department of Transportation‘s National Highway Traffic Safety Administration (NHTSA). We conducted interviews with agency officials and reviewed agency statutes, regulations, and other documents. For our comparative analysis of other countries‘ product safety authorities, we selected Australia, Canada, China, the European Union (EU), and Japan for review.3 We developed a set of questions concerning consumer product safety authorities, practices, and procedures and worked through the U.S. Department of State to distribute the questions to appropriate contacts at U.S. embassies overseas and, in some cases, to foreign embassies in Washington, D.C. We conducted interviews with product safety officials from Canada, the EU, and Japan, and with U.S. officials at the embassies in Australia, Canada, and China. We received written responses to our questions from the U.S. embassies in Australia, Canada, and China; from officials with the Embassy of Japan in Washington, D.C.; and from consumer product safety officials in the EU. We also reviewed documents regarding product safety in the selected countries and reports on consumer product safety prepared by the Organization for Economic Cooperation and Development (OECD). To evaluate CPSC‘s plans to prevent the entry of unsafe products in the future, we reviewed CPSC‘s 2010 Performance Budget Request and compared CPSC‘s planning efforts with guidance GAO has developed to assess implementation of the Government Performance and Results Act. Appendix I provides a more detailed description of our objectives, scope, and methodology. We conducted this performance audit from October 2008 to August 2009, in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

BACKGROUND CPSC was created in 1972 under the Consumer Product Safety Act to regulate consumer products that pose an unreasonable risk of injury; to assist consumers in using products safely; and to promote research and investigation into product-related deaths, injuries, and

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illnesses.4 The Consumer Product Safety Act consolidated existing federal safety regulatory activity related to consumer products within CPSC. As a result, in addition to general responsibilities for protecting consumers against product hazards, the duties and functions under the following four statutes were transferred to CPSC:5

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the Flammable Fabrics Act, which among other things, authorizes CPSC to prescribe flammability standards for clothing, upholstery, and other fabrics;6 the Federal Hazardous Substances Act, which establishes the framework for the regulation of substances that are toxic, corrosive, combustible, or otherwise hazardous;7 the Poison Prevention Packaging Act of 1970, which authorizes CPSC to prescribe special packaging requirements to protect children from injury resulting from handling, using, or ingesting certain drugs and other household substances;8 and the Refrigerator Safety Act of 1956, which mandates CPSC to prescribe safety standards for household refrigerators to ensure that the doors thereof can be opened easily from the inside.9 CSPC has also subsequently been charged with administering the Virginia Graeme Baker Pool and Spa Safety Act, which establishes mandatory safety standards for swimming pool and spa drain covers, as well as a grant program to provide states with incentives to adopt pool and spa safety standards.10 In addition, CPSC has been charged with administering the Children‘s Gasoline Burn Prevention Act, which establishes safety standards for childresistant closures on all portable gasoline containers.11 Thus, CPSC‘s jurisdiction is extremely broad, covering thousands of types of products. According to CPSC, this jurisdiction covers over 100,000 different manufacturers and generally includes all consumer products except food, drugs, and cosmetics, which are regulated by FDA; pesticides, which are regulated by the Environmental Protection Agency; automobiles and other on-road vehicles, which are regulated by the Department of Transportation; flotation devices, which are regulated by the Coast Guard; and firearms, tobacco, and alcohol, which are regulated by the Department of Justice. The Consumer Product Safety Act established CPSC as an independent regulatory commission. The rationale for establishing independent commissions such as CPSC includes these assumptions: (1) long-term appointment of commissioners would promote stability and develop expertise, (2) independent status would insulate the commissioners from undue economic and political pressures, and (3) commissioners with different political persuasions and interests would provide diverse viewpoints. The act provides for the appointment by the President of five commissioners for staggered 7-year terms. However, no more than three commissioners have served at one time since 1986, and the commission has been led by two commissioners since 2006.12 One of these commissioners is designated the Chairman, who directs all the executive and administrative functions of the agency. CPSC was designed as a complement to tort law, under which one may seek compensation for harm caused by another‘s wrongdoing. The threat of legal action under tort law plays an important role in assuring that companies produce safe products. However, tort law is primarily a postinjury mechanism, and foreign manufacturers are usually outside of the U.S. tort law system. Therefore, CPSC has certain authorities intended to prevent unsafe consumer products from entering the market in the first place.

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CPSC Protects Consumers Primarily through Product Safety Standards Under several of the acts that it administers, CPSC primarily protects consumers from unreasonable risk of injury or death by issuing regulations that establish performance or labeling standards for consumer products. These standards are often referred to as ―mandatory standards.‖13 CPSC issued 38 mandatory standards between 1990 and 2007. If CPSC determines that there is no feasible standard that would adequately protect the public from danger, CPSC may issue regulations to ban the manufacture and distribution of the product.14 Many consumer products are subject to voluntary standards. These voluntary standards, which are often established by private standard-setting groups, do not have the force of law.15 However, many voluntary standards are established with input from consumer groups and industry and, as a result, are often referred to as ―consensus standards.‖ In addition, the 1981 amendments to the Consumer Product Safety Act require CPSC to defer to a voluntary standard—rather than issuing a mandatory regulation—if CPSC determines that the voluntary standard adequately addresses the hazard and that there is likely to be substantial compliance with the voluntary standard.16 Between 1990 and 2007, CPSC worked with industry and others to develop 390 voluntary standards related to consumer products.

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Import Safety Responsibility within CPSC CPSC‘s policy on imported products states that the commission will seek to ensure that importers and foreign manufacturers, as well as domestic manufacturers, distributors, and retailers, carry out their obligations and responsibilities under the five acts. The commission will also seek to establish, to the maximum extent possible, uniform import procedures for products subject to the acts the commission administers.17 Two CPSC staff offices have primary responsibility for carrying out this policy: the Office of International Programs and Intergovernmental Affairs and the Office of Compliance and Field Operations. The Office of International Programs and Intergovernmental Affairs was created in 2004 to provide CPSC with a more comprehensive and coordinated effort at the international, federal, state, and local levels in developing and implementing consumer product safety standards. The office conducts activities and creates strategies aimed at ensuring greater import compliance with recognized American safety standards. A major emphasis of this program is encouraging foreign manufacturers to establish product safety systems as an integral part of the manufacturing process. The office is also involved in coordinating international consumer product safety efforts with such U.S. federal agencies as the Departments of Commerce and State. It also ensures that CPSC regulatory efforts are consistent with U.S. international trade obligations by coordinating with the United States Trade Representative. As of July 2009, the office was staffed by four full-time employees. The Import Surveillance Division within the Office of Compliance and Field Operations was created in March 2008 and has primary responsibility for CPSC‘s product surveillance program at ports of entry. CPSC, in cooperation with other appropriate federal agencies, is required to maintain a permanent product surveillance program for preventing the entry of unsafe consumer products into the commerce of the United States.18 Previously, CPSC operated the import surveillance program through product safety investigators staffed in

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multiple regions throughout the country who included among their investigative responsibilities ports of entry in their particular regions. Over the years, the numbers of CPSC regional offices and product safety investigators have been reduced. CPSC states that these product safety investigators continue to support the import surveillance program, operating in 48 locations throughout the country. The Import Surveillance Division marks the first permanent, full-time presence of CPSC investigators at key ports of entry, according to CPSC. As of July 2009, the division was staffed by 11 full-time employees—9 compliance investigators located at seven ports of entry and a Director and Supervisory Compliance Investigator located at CPSC headquarters in Bethesda, Maryland. The compliance investigators are supported by compliance officers, technical staff, attorneys, and other staff at CPSC headquarters. There are over 300 ports of entry in the United States.

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CPSC Works Closely with CBP at Ports of Entry CBP notifies CPSC and other regulatory agencies with import safety responsibilities of the arrival of imported products and provides information about those products. Under several of the acts that CPSC administers, CPSC identifies potentially unsafe products and requests that CBP set them aside for CPSC examination. CPSC has implemented programs at some ports for CBP to target certain categories of products based on their Harmonized Tariff Schedule (HTS) codes.19 CBP has import specialists at major ports who specialize in certain commodities, including consumer products. They analyze manifest, entry, and other import data to identify shipments for CPSC review.20 In some instances, CBP will independently identify shipments for CPSC examination. Once samples are delivered to or taken by CPSC for examination, CPSC may detain the shipment pending further examination and testing, conditionally release the shipment to the importer‘s premises pending examination and testing, or release the shipment to the importer outright. Compliance investigators examine the sample to determine whether it complies with the relevant mandatory standard(s); is accompanied by a certification of compliance with the relevant product safety standard that is supported by testing, in some instances by a third party; is or has been determined to be an imminently hazardous product;21 has a product defect that presents a substantial product hazard;22 or is produced by a manufacturer who failed to comply with CPSC inspection and recordkeeping requirements. If compliance investigators decide that further testing of a sample is necessary, they will send the sample to the CPSC Product Testing Laboratory or to a CBP laboratory.23 If the sample is found to violate any of the above criteria, CPSC is authorized to refuse admission of the shipment. Consumer products that are refused admission will be destroyed unless the Secretary of the Treasury allows the product to be exported.24 CPSC may instead instruct CBP to seize shipments upon finding a prohibited act, which according to CPSC is the most common outcome when a violation is discovered. The importer may be subject to civil or

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criminal penalties.25 See figure 1 for an overview of CBP and CPSC‘s current process for conducting inspections at ports of entry.

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Sources: GAO analysis of CBP and CPSC information; Art Explosion (clip art). Figure 1. Overview of CBP and CPSC‘s Current Process for Inspections of Consumer Goods at U.S. Ports of Entry.

CPSC relies on CBP to carry out key import surveillance activities at ports of entry. In addition to its numerous antiterrorism and trade responsibilities, CBP faces pressure from the international trade community to quickly move compliant shipments into commerce. Factors such as the high volume of containers, financial incentives for longshoremen to unload ships quickly, and the limited amount of time CBP has to identify and examine cargo contribute to the challenges CBP faces in facilitating commerce.26 In addition, CBP enforces regulations for 45 other federal agencies. Importers place pressure on CBP to correctly identify violations because the cost of storing CBP-detained products at privately run container examination stations is high. CPSC surveillance activity with CBP at ports of entry has fluctuated in recent years. For example, as shown in figure 2, the number of samples that CPSC collected for examination dropped from 1,348 in fiscal year 1999 to 710 and 514 in fiscal years 2002 and 2003 and has still not reached the 1999 level, despite an increa se in imports of products under CPSC jurisdiction of about 101 percent.

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Sources: GAO analysis of CPSC and U.S. International Trade Commission data. Note: Data on import samples are reported on a fiscal-year basis. Data on imports under CPSC jurisdiction are reported on a calendar-year basis.

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Figure 2. CPSC Surveillance A ctivity at Ports of Entry Compared to Imports of Consumer Goods, 1998-2008.

CPSC’S AUTHORITIES HAVE THE POTENTIAL TO BE EFFECTIVE, BUT IMPLEMENTATION IS LIMITED BY INCOMPLETE INFORMATION ON IMPORTED PRODUCTS AND RESOURCE AND PRACTICAL CONSTRAINTS Consensus exists that CPSC‘s authorities have the potential to be effective in preventing the entry of unsafe products into the United States. Although CPSC has made limited progress in measuring the effectiveness of its authorities over imported products, the agency believes that new authorities granted in CPSIA should increase compliance with mandatory standards and enhance its ability to monitor compliance with voluntary standards at ports of entry. Private industry sources and others we interviewed generally said that CPSC‘s authorities are potentially effective but that implementation is limited by competing priorities and resource and practical constraints.

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Consensus Exists That CPSC Has Broad Authority over Imported Products, but CPSC’s Assessment of Effectiveness Has Been Limited There is consensus among those we interviewed that CPSC has broad authority to prevent the entry of unsafe consumer products into the United States, particularly in light of new authorities that strengthen its ability to enforce mandatory standards and protect consumers from unsafe products subject to voluntary standards at ports of entry. As described above, CPSC primarily protects consumers from unreasonable risk of injury by promulgating mandatory standards and working with private standard-setting organizations to promulgate voluntary standards, and CPSC has broad authority to enforce those standards at ports of entry. In particular, CPSC and other product safety experts believe CPSC‘s enforcement of mandatory standards at ports of entry will be strengthened because now all products subject to a mandatory standard under any law administered by CPSC must be accompanied by a certification of compliance that is supported by product testing.27 In addition, every manufacturer or private labeler of a product subject to a children‘s product safety rule must have samples of the product tested by an accredited third-party laboratory for conformance with the applicable mandatory standard.28 For many years, CPSC focused import surveillance activities on enforcement of certain mandatory standards for consumer products, primarily toys, fireworks, and lighters.29 The new testing requirement puts greater burden on industry to ensure that products comply with mandatory standards. If implemented properly, CPSC should be able to use the testing and certification requirements to strengthen surveillance of regulated products at ports of entry. Furthermore, CPSC believes its ability to monitor compliance with voluntary standards at ports of entry will be strengthened by new authority to create a ―substantial product hazard list.‖30 As described above, many consumer products are produced according to voluntary standards. In addition, many products are subject to no standards. CPSC primarily protects consumers from unsafe products subject to voluntary or no standards by declaring them ―substantial product hazards‖ when the products have a defect that creates a substantial risk of injury. However, CPSC faces difficulty at ports of entry identifying defects in products subject to voluntary or no standards because defects are not always apparent until the product has been used by the public.31 With implementation of the substantial product hazard list, CPSC will be able to target new shipments and refuse admission of products subject to voluntary standards that it has already determined have a defect constituting a substantial risk of injury.32 Despite this broad authority, CPSC has made limited progress in measuring the effectiveness of its authorities to prevent the entry of unsafe consumer products. CPSC measures the performance of its import surveillance program by the number of product samples collected and by the number of samples ultimately found to be unsafe and therefore seized. CPSC is now considering altering this metric so that it will track all shipments that CPSC investigators examine, rather than just those samples collected and tested. Furthermore, CPSC measures the performance of its Office of International Programs and Intergovernmental Affairs by the number of outreach events conducted. These metrics provide measures of the output of program staff but do not necessarily provide accurate measures of the effectiveness of the programs. In the 1990s, CPSC used industry compliance with mandatory standards as an alternative basis for measuring the agency‘s effectiveness,

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what it termed the Comprehensive Plan. The plan was designed to examine the compliance of these products with mandatory standards on a periodic basis and then identify problem areas for focusing limited agency resources. CPSC did not continue the Comprehensive Plan after the mid-1990s because the data indicated that compliance was high, and CPSC believed that the plan did not help it address problems with noncompliant products. CPSC sought information from the public in 2008 to develop a new methodology that would replace the Comprehensive Plan. CPSC reported receiving two responses, but commission staff stated that they did not pursue further work because the responses did not address their needs for developing new performance measures. While CPSC recognizes the need for outcomeoriented performance measures and has taken steps to develop new measures, without these measures, CPSC may not be able to determine how effective its authorities are for preventing the entry of unsafe products.

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Implementation of CPSC’s New Authorities to Prevent Entry of Unsafe Products into the United States Has Been Delayed While CPSC has broad authority to prevent the entry of unsafe consumer products into the United States, there have been delays in implementing new authorities CPSC received in CPSIA. According to CPSC, the agency has more than 40 rulemakings to conduct under CPSIA, including approximately 20 rulemakings to initiate or complete by August 2010, which has contributed to the delay in implementing the act. In particular, the two new authorities discussed above—certain testing and certification requirements and the substantial product hazard list—have not been implemented. CPSC issued a stay of enforcement of certain testing and certification requirements until February 10, 2010, delaying implementation of these standards and raising questions among manufacturers subject to this requirement.33 CPSC stated that it did not complete the rulemaking process because it was unable to respond to innumerable inquiries from industry seeking relief from the testing requirement at a time when the agency faced severe resource limitations because it was operating under the prior year‘s budget. In addition, to date CPSC has not conducted rulemaking to implement the substantial product hazard list. The effectiveness of CPSC‘s new authorities will not be clear until CPSC completes its rulemaking and demonstrates the ability to enforce these regulations. Another factor contributing to delays in implementation of new authorities is the need for CPSC to balance its mission to protect consumers with industry interests. CPSC‘s mission is to protect the public from unreasonable risk of injury associated with consumer products, and CPSC is also required to work with industry to develop product safety standards, collect information about unsafe products, and conduct recalls. Private companies have expressed concerns about CPSC‘s implementation of CPSIA, particularly the expanded testing and certification requirements, which, as noted earlier, helped contribute to CPSC‘s decision to delay enforcement of these provisions. In public comments on CPSIA, several industry representatives commented that the certification requirements are duplicative and could cause them to incur tremendous costs due to the complexity of their business operations. For example, industry representatives stated that large manufacturers produce hundreds of

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 13 thousands of variations of their products that may require testing and certification, while small manufacturers may have limited product lines across which to spread costs. In addition to industry concerns, CPSC has also faced concerns from consumers that CPSC‘s implementation of CPSIA has not, at times, fulfilled the consumer protection goals of the act. In one recent example, consumer groups challenged CPSC‘s advisory opinion that CPSIA‘s provisions prohibiting the sale of children‘s products that contain certain chemicals called phthalates did not apply retroactively to inventories existing prior to the effective date of the prohibitions. These groups were concerned that if the phthalate prohibitions were not applied retroactively, consumers would continue to be exposed to unsafe products in the marketplace. The consumer groups filed suit in a federal district court seeking a declaratory judgment that CPSC‘s advisory opinion, which was issued at the request of certain wholesale and retail entities, was contrary to CPSIA, and thus violated the Administrative Procedure Act. The district court held that the phthalate prohibitions in CSPIA unambiguously applied to existing inventory and set aside CPSC‘s opinion.34 According to some industry representatives we interviewed, retailers are taking the lead in product testing and certification in response to industry‘s uncertainty over how CPSC will enforce CPSIA provisions. These representatives believed that retailers are ahead of CPSC in this regard. For example, one industry group said that although CPSC has stayed enforcement of many of its certification requirements, retailers still require suppliers to provide certifications, and some retailers had more stringent lead standards than CPSIA. According to industry groups, U.S. companies, particularly retailers, have an incentive to institute and enforce stringent product safety standards because selling products that cause injury or death can have negative impacts on their brands. The U.S. tort system that exposes companies selling unsafe products to lawsuits also helps to ensure that companies comply with product safety standards. To respond to industry concerns about how to comply with safety standards under current and prior consumer product safety laws, some industry groups have also developed or are developing their own testing and certification programs.35 CPSC indicated that while these types of programs can help improve compliance with safety standards, there are limits to how well this type of industry self-regulation can be used to protect consumers. They indicated that there is a trade-off between consumer protection and industry cooperation; if the requirements are too onerous, companies might not participate in these voluntary programs. Balancing the interests of both consumer and industry participants adds complexity in completing CPSC‘s implementation of CPSIA.

CPSC Needs Better Targeting Information to Strengthen Enforcement with CBP at Ports of Entry CPSC needs better targeting information to strengthen its ability to identify risks from imported products and communicate inspection priorities to CBP. CPSC and CBP have a cooperative relationship at ports of entry. That is, while CPSC relies on CBP to carry out key import surveillance and targeting activities at ports, CBP relies on CPSC to communicate the greatest risks and its inspection priorities among consumer products. However, CPSC has not developed formal systems for assessing risks and focusing inspection activities with CBP.

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Furthermore, CPSC does not have access to information that would enable the agency to effectively target potentially unsafe imported products for inspection.

Updated MOU with CBP Would Be Useful as CPSC Develops Its Risk Assessment Methodology In the past, CPSC has generally used informal systems to target risks from imported products and to conduct operations with CBP at ports of entry with some positive results. CPSC has generally been effective using its informal systems to target certain products for inspection, according to several product safety experts we interviewed. For instance, CPSC has targeted imported fireworks for increased inspections during the summer months. CPSC has also had positive results from its participation in Operation Guardian, a multiagency effort to combat the increasing importation of substandard, tainted, and counterfeit products that pose a health and safety risk to consumers.36 Another program that CPSC stated has produced positive results is an expansion of the CBP Importer Self-Assessment Program that was initiated in October 2008. The expansion, known as the Importer Self-Assessment Product Safety Pilot, aims to prevent unsafe imports from entering the United States by requiring volunteer companies to meet specified internal monitoring criteria in exchange for priority in testing, reductions in the testing conducted, and access to CPSC training programs.37 However, as discussed above, CPSC targeted relatively few imported consumer products for inspection under its informal system. CPSIA requires CPSC to establish a formal risk assessment methodology that will require updating the terms of the relationship between the agencies. CPSC and the former U.S. Customs Service (now CBP) established a memorandum of understanding (MOU) in 1990 that serves as the foundation for the working relationship of the agencies for enforcement of CPSC‘s authorities over imported products. For example, the MOU provides for ―the joint conduct of a mutually agreed number of high-visibility, intensive inspection operations annually.‖ This provision is consistent with CPSC‘s informal system for targeting risks. The MOU is now out of date and does not reflect anticipated changes to CPSC‘s relationship with CBP required under CPSIA. CPSIA requires CPSC, by August 2010, to develop a methodology for identifying shipments of imported consumer products that are likely to violate import provisions enforced by CPSC.38 A CPSC official told us that, as part of the agency‘s work to develop this risk assessment methodology, CPSC plans to create a flowchart of the current product-entry process to identify gaps in any current CPSC authorities to stop unsafe products at the ports. The official noted that CPSC anticipates completing the flowchart later this year. Updating the 1990 MOU between CPSC and CBP and thereby revisiting the roles and responsibilities of each agency would be a useful way for CPSC to identify gaps in the current product entry process and speed completion of its risk assessment methodology.39 Better Advance Shipment Data Would Strengthen CPSC’s Targeting Efforts During interviews with CPSC staff and our visit to a U.S. port of entry to determine how CPSC prevents the entry of unsafe products into the United States, we found that CPSC does not have access to CBP data that would provide CPSC with information about products in a shipment before it arrives in the United States. CPSC has access to entry summary data, which CBP generally receives shortly before a shipment enters the United States or, in some

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 15 cases, as many as 10 days after the shipment has been released into commerce. However, CPSC does not have access to manifest data, which is provided to CBP 24 hours before a shipping vessel bound for the United States is loaded at a foreign port.40 CPSC and CBP established a second MOU in 2002, which superseded the 1990 MOU, specifying procedures and guidelines for information sharing between the agencies with a particular focus on CPSC access to CBP data systems. The 2002 MOU was intended to allow CPSC access to both entry summary and manifest data. According to a CPSC official, CBP has not provided CPSC with access to manifest data because it believed the data were not specific enough for CPSC purposes. For instance, the manifest data generally do not include the name of the importer and may not have specific Harmonized Tariff Schedule codes to help CPSC identify the merchandise in the shipment. However, CPSC still believes that manifest data will help the agency improve its targeting, as it will give CPSC more timely information on shipments and potentially more specific information as CPSC seeks to revise the Harmonized Tariff Schedule codes to better align them with the categories of products they regulate. CBP also acknowledged that, while CPSC can use the entry summary data to target future shipments for inspection, CPSC cannot place inspection holds on shipments that are about to depart for or are in transit to the United States without the manifest data. In comparing CPSC border surveillance activities with those of other federal agencies that regulate the safety of products used by consumers, we found that FDA has a stronger capability to target imports using CBP data (discussed further below). FDA receives advance shipment data from CBP of all entries containing food under FDA jurisdiction that arrive at ports, which FDA then screens electronically against criteria it developed to detect potential violations. CPSC and CBP state that they have been working together to resolve information-sharing issues. Specifically, in February 2007, CPSC applied for access to the International Trade Data System (ITDS), which CBP intends to be a single source for import and export documentation that is to provide participating agencies quicker access to data and improved ability to identify potentially unsafe shipments of consumer products.41 As part of the application process, CPSC has submitted to CBP for review an operations plan (a ―Concept of Operations‖ or ―ConOps‖) and an update to the 2002 MOU with guidelines for the exchange of information.42 The agencies have had follow-up discussions on these plans; however, CBP has reported that implementation of ITDS has been delayed. As a result, CPSC‘s efforts to access more complete import data to help it better target incoming shipments have also been delayed. CPSC staff said that they anticipate this work will not be completed until at least 2011. In addition to this effort, CPSIA requires CPSC and CBP to improve information sharing and coordination. Specifically, CPSIA requires CPSC to develop, by August 2009, a plan for sharing information and coordinating with CBP.43 According to CPSIA, the proposed plan is to consider, at a minimum, the number of CPSC staff that should be stationed at U.S. ports and the nature and extent of cooperation between CPSC and CBP at the ports. The plan is also to discuss the nature and extent of cooperation between CPSC and CBP at the National Targeting Center or its equivalent.44 CPSC has not completed this plan, and it is unlikely to do so until it updates information-sharing agreements with CBP. A CPSC official told us that as part of developing this plan for sharing information with CBP, CPSC is seeking to assign a staff member to a planned CBP targeting center that would focus on health and safety issues. This targeting center, which would be equivalent to the National Targeting Center, would seek to identify shipments of imported products that should

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be stopped at the ports for further screening and review. A CPSC official said that, in assigning a staff person to this targeting center, the agency would have access to CBP‘s Automated Targeting System.45 However, creation of the health and safety planned targeting center has been delayed, so CPSC has not been able to place staff at the center or access CBP targeting information, delaying its ability to better target imported products. A CPSC official explained that the analytical approach that FDA took by creating its own system for analyzing data would require a considerable investment of both time and money. CPSC prefers the option of working with CBP through the planned targeting center to leverage this analytical capability. CPSC believes this option would be more efficient than developing its own system to analyze data.

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CPSC’s Enforcement of Import Safety Authorities Is Limited by Resource and Practical Constraints CPSC‘s enforcement of its authorities to prevent the entry of unsafe products into the United States is limited by resource and practical constraints. Specifically, CPSC has few staff at ports of entry and limited analytical and laboratory support. Furthermore, although CPSC has authority to destroy products refused admission, it lacks a source of funding to immediately pay for the costs of destruction. In addition, while CPSC has authority to condition the importation of consumer products based on compliance with CPSC inspection requirements, there are practical constraints on the agency‘s ability to conduct inspections of foreign manufacturing plants. CPSC‘s ability to inspect shipments for potential violations at ports of entry is limited by resource constraints, such as few staff at ports and limited analytical and laboratory support. In passing CPSIA, Congress recognized the need to strengthen CPSC‘s resources, including requirements that CPSC increase the number of full-time employees to at least 500 by fiscal year 2013 and that CPSC hire additional personnel to be assigned to U.S. ports of entry.46 As noted above, CPSC had 9 compliance investigators stationed at 7 ports as of July 2009, as well as 100 product safety investigators in 48 other locations across that country that may help to conduct periodic inspections at ports of entry. CBP staff indicated that having a CPSC compliance investigator collocated at ports has been useful, and during our visit to a U.S. port of entry we saw the cooperative relationship between agency officials. Furthermore, a CPSC official said that currently there is limited analytical support at CPSC headquarters to assist in import surveillance work. According to CPSC, the agency cannot establish a greater presence at U.S. ports without having the requisite analytical support. CPSC also has limited laboratory support for testing potentially unsafe products and has faced significant backlogs at various times. As of April 2009, CPSC had 28 engineers and scientists at its laboratory. CPSC‘s laboratory facility is located across the country from where a large percentage of imported goods enter the United States. Moreover, fireworks, which are heavily targeted for inspection, must be tested at a separate facility under current procedures. As a result of these conditions, testing backlogs have inhibited import surveillance efforts. In May 2009, CPSC announced that it had secured and was in the process of outfitting a new laboratory with enhanced testing facilities. CPSC also announced that certain support staff from CPSC headquarters would be collocated at the lab to assist the laboratory staff. However, the new facilities still cannot

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 17 accommodate fireworks testing. Moreover, the new facility does not provide CPSC with a presence on the West Coast, where many consumer products enter the United States. As discussed below, in comparing CPSC‘s resources supporting border surveillance with those of other federal agencies that regulate the safety of products used by consumers, particularly FDA and USDA, we found that CPSC‘s resources are much less than those of these other agencies. According to CPSC and CBP, CPSC can refuse entry for products that violate U.S. laws, but CPSC does not have immediate funding available to subsequently destroy these products if the importers do not destroy or export these products at their own expense. Instead, CPSC generally asks CBP to seize unsafe products, and CBP is authorized to access the U.S. Department of the Treasury‘s Forfeiture Fund to cover the cost of product destruction. The Treasury Forfeiture Fund is also available to CBP for other enforcement purposes, so that any money CBP uses for destroying seized products reduces the amount of money available to CBP for other purposes. Moreover, CBP is concerned that the costs of product destruction are likely to increase as CPSC fully implements CPSIA. Although CBP requires that formal entries be covered by a bond, which is another funding source that may be used to cover the cost of product destruction, we found that CBP has not pursued bonds for that purpose because they may not cover the full cost of destruction. CPSC officials also noted that bonds are not immediately available for product destruction but may only be recovered to reimburse destruction costs. However, a new mandate in CPSIA requires CPSC to work with CBP to set bond amounts sufficient to cover these costs.47 CBP and CPSC‘s efforts to implement this requirement are still in process. Given the limited resources immediately available for product destruction, CBP indicated that CPSC and other federal agencies might explore other funding sources for this purpose. However, we previously found that estimating the cost of destroying consumer products is difficult given the wide range of products CPSC oversees, making it challenging to determine the appropriate size of a dedicated fund. In addition to setting aside enough funds for product destruction, CPSC would have to consider establishing parameters on the use of any funding source it administers.48 While CPSC has broad authority to conduct inspections of manufacturers and importers, significant resource and practical constraints limit its ability to conduct traditional inspections of foreign manufacturing plants. CPSC is required by rule to condition the import of a consumer product on the product manufacturer‘s compliance with CPSC inspection and recordkeeping requirements.49 CPSC does not conduct inspections in foreign countries, and CPSC and many product safety and international trade experts cite several constraints on its ability to do so. Specifically, these parties state that U.S. inspectors would likely need the consent of both the foreign manufacturer and the foreign government to conduct an inspection. Other experts stated that such consent from a foreign government, if granted, may be accompanied by a request for the same rights to inspect U.S. manufacturing plants. Another constraint on inspections of foreign manufacturers is that such a program would need to be prohibitively large in order to be effective, perhaps larger than CPSC‘s domestic inspection program. As noted earlier, CPSC had about 100 product safety investigators in 48 locations to conduct its domestic inspections as of July 2009. Also, it is not clear what CPSC would look for when inspecting foreign manufacturing plants given that CPSC evaluates the final product for compliance with product safety regulations rather than the production process. As noted above, CPSC may condition the import of consumer products on cooperation with inspections. However, ensuring that the specific manufacturer‘s products do

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not enter the United States would be difficult without detailed knowledge of individual companies‘ supply chains, which could be gained through inspection of the manufacturer‘s records.50 Due to these legal and practical constraints, CPSC stated that expanding its international education and outreach activities rather than conducting inspections of foreign manufacturing plants would more effectively prevent the entry of unsafe consumer products.

AUTHORITIES OF SELECT AGENCIES ARE COMPARABLE TO CPSC’S, BUT FDA AND USDA’S BORDER SURVEILLANCE ACTIVITIES AND OVERSEAS PRESENCE PROVIDE USEFUL INFORMATION FOR STRENGTHENING CPSC’S IMPLEMENTATION OF ITS AUTHORITIES CPSC‘s regulatory authority to prevent the entry of unsafe imports is generally comparable to that of certain other federal agencies with substantial responsibility over the safety of products entering the United States. However, various border surveillance activities of FDA and USDA—particularly with respect to obtaining advance shipment data, allocating staff resources to border operations, and targeting capabilities, as well as efforts to work with foreign governments to educate foreign manufacturers about U.S. safety standards—provide useful information for strengthening CPSC‘s efforts to prevent the entry of unsafe products.

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CPSC’s Authorities to Prevent the Entry of Unsafe Products Are Generally Comparable to Those of Other Federal Agencies CPSC‘s authorities to prevent the entry of unsafe products are generally comparable to the authorities of four other federal agencies: FDA, which oversees, among other things, food, drugs, and medical devices; NHTSA, which, through delegated authority of the Secretary of Transportation, oversees motor vehicles and equipment; Food Safety and Inspection Service (FSIS), an agency of USDA that oversees egg products, poultry, and meat; and Animal and Plant Health Inspection Service (APHIS), an agency of USDA that oversees plants and animals. CPSC‘s authorities provide it with similar or stronger authority to require or engage in certain activities compared with the authorities of the other agencies we studied. Safety standards: All of these agencies have authority to regulate and enforce product safety standards or bans relevant to products under their jurisdiction.51 Border surveillance: All of these agencies except NHTSA appear to have specific authority to conduct border surveillance activities and broad authority to refuse entry to items that fail to comply with relevant standards, among other things.52 NHTSA officials told us that, like CPSC, NHTSA requests that CBP detain and seize products at the border on its behalf. Product certification/testing: Similar to FDA, manufacturers must certify to CPSC that their products comply with relevant standards, and this certification must be

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 19 based on a reasonable testing program or, in the case of certain children‘s products, the tests must be performed by third parties.53 Under FSIS, containers of eggs, egg products, poultry, and meat must be labeled as having passed inspection. Although NHTSA authorities require manufacturers of vehicles and equipment to certify that products comply with applicable federal safety standards, these certifications are not required to be based on testing. Temporary hold at ports: CPSC, FDA, FSIS, and APHIS have the authority to temporarily hold shipments at U.S. ports for inspection.

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Foreign inspection: Like FDA and FSIS, CPSC is not expressly prohibited from requesting consent to inspect foreign facilities. Specifically, CPSC may request inspection of foreign manufacturing or distribution facilities, third-party testing laboratories, or conveyances used to transport consumer products in commerce.54 As discussed above, CPSC does not conduct foreign inspections. Both FSIS and FDA have been successful in obtaining access to foreign facilities for the purpose of inspections or audits where incentives are strong for foreign entities to grant this access. For example, access is generally provided for requests that are tied to applications or audits before products may be eligible for import into the United States.55 FDA officials told us that in practice, if a foreign firm refuses to permit such an inspection, FDA can sometimes refuse admission of products offered for import into the U.S. For example, the refusal to permit an inspection could lead to a product not receiving a required pre-market approval or the refusal to permit an inspection, combined with other information, could support a determination of the appearance of a violation. According to NHTSA, it does not have the authority to inspect foreign facilities for the manufacture of vehicles and vehicle equipment imported into the United States. Consent to local court jurisdiction: Based on our interviews with officials at the federal agencies we studied, none of the agencies requires foreign manufacturers to consent to the jurisdiction of local courts with respect to enforcement actions. Some agencies, including CPSC, told us they do not see a need for this requirement, as they have been able to effectively carry out their enforcement duties under existing authorities. For example, foreign manufacturers seeking to offer motor vehicles for import into the United States are required by statute to designate a U.S. resident or firm as its agent to receive service of notices and process in administrative and judicial proceedings, and service on the agent is deemed to be service on the foreign manufacturer or importer.56 Also, FSIS told us that they expect foreign governments to carry out enforcement actions for their manufacturers that are certified to export to the United States. CPSC noted that it has satisfied its enforcement objectives by pursuing the domestic partners—manufacturers, importers, and retailers—of the foreign manufacturer without needing to resort to adjudicative proceedings. For example, in June 2009, CPSC reached a $2.3 million settlement with Mattel, Inc., regarding the importation of toys made in China that violated a federal ban on paint containing lead.57 Furthermore, CPSC also has the ability to settle enforcement actions with foreign parties. For example, in July 2009, CPSC reached a $50,000

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settlement with a Hong Kong corporation with offices in the United States regarding the importation of toys manufactured in China that also violated the commission‘s lead paint ban.58 Finally, CPSC staff we interviewed stated that the agency prefers to expand its international education and outreach programs rather than require foreign manufacturers to consent to U.S. jurisdiction to effectively prevent the entry of unsafe products, although they acknowledged that consent to jurisdiction or a requirement of a U.S. agent for service of process would be helpful.59 Appendix II contains a more detailed discussion of the elements of establishing personal jurisdiction in U.S. courts. The requirements of the Consumer Product Safety Act appear to demand more from manufacturers than NHTSA with respect to preventing the entry of unsafe imports. NHTSA‘s key authorities to ensure the safety of imported goods are to prescribe mandatory vehicle safety standards and to require foreign and domestic manufacturers to certify compliance with these standards. However, these certifications are not required to be based on a testing program, unlike CPSC‘s new certification requirements for children‘s products, nor are the results of any testing required to be reported to NHTSA as a condition to entry. Appendix III contains a more detailed description of the agencies‘ key authorities for preventing the entry of unsafe products. Where key differences exist in these agencies‘ authorities, they appear to be due to differences in the types of products under an agency‘s jurisdiction and the particular risks that are presented. As such, these differences are not directly applicable to CPSC as it improves its ability to ensure the safety of imported goods. FSIS‟s foreign country equivalency: A major feature of FSIS‘s framework for ensuring the safety of imported meat, poultry, and egg products is a requirement that foreign countries have a certified food safety system equivalent to that of the United States. As of fiscal year 2008, 34 foreign countries were eligible to import these products into the United States. According to an FSIS budget document, the United States invests substantial resources, over $800 million in fiscal year 2008, in the inspection of domestic products.60 The amount of funds spent on domestic inspection is relevant given that the concept of foreign equivalency is predicated on there being a domestic inspection program. As such, it is unclear how FSIS‘s country equivalency program could be adapted for CPSC given that CPSC does not have comparable resources for the inspection of domestic products, with a budget of about $80 million in fiscal year 2008 for all of its activities. Furthermore, the concept of equivalency for meat, poultry, and egg products is established in a 1994 multilateral trade agreement, to which the United States is a signatory.61 According to the United States Trade Representative, it is not clear whether any WTO Agreement to which the United States is a party specifically precludes application of an equivalency requirement to consumer products. FDA‟s preapproval of certain drugs and medical devices: In addition, FDA requires drug manufacturers to obtain prior approval for marketing certain drugs in the United States and for selling certain medical devices.62 However, FDA‘s prior approval requirement would be inefficient for CPSC given the diversity of products it oversees

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 21 and the frequency with which these products change or are updated. CPSC oversees thousands of types of consumer products, and many of the products it oversees, especially toys, change or are updated every year. Other key statutory differences across agency authorities need not be addressed by providing CPSC with new authorities because CPSC officials have told us they already consider CPSC to have similar authorities. Agreements with foreign governments and overseas presence: FDA is authorized to participate through appropriate processes with representatives of other foreign countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements, including international agreements such as mutual recognition agreements, agreements to facilitate commerce in devices, and memorandums of understanding, among other things.63 As discussed below, CPSC already has MOUs with foreign governments, including China and the EU, and is finalizing plans for its first overseas office in Beijing, China, in 2010.

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Other Federal Agencies’ Border Surveillance and Overseas Activities to Prevent the Entry of Unsafe Products May Be Useful for CPSC to Consider As CPSC considers ways to improve its ability to prevent the entry of unsafe imports, various agencies‘ border surveillance and outreach activities to foreign governments and industry provide useful information. FDA, FSIS, and APHIS have expansive border surveillance activities based on the amount of data obtained on incoming shipments, number of staff supporting border surveillance operations, and targeting programs and information technology systems that help to integrate data from various sources for use in making border entry decisions. These capabilities enable these agencies to screen incoming shipments for a greater number of risks than CPSC does. According to data provided by CPSC, the agency has generally focused on relatively few categories of consumer products since 2001, specifically toys, fireworks, lighters, and electrical products (such as holiday lights and extension cords). FDA and FSIS have better access to data for screening incoming shipments than CPSC. FDA receives shipment data from CBP for all entries under FDA jurisdiction that are imported or offered for import, which FDA then screens electronically against criteria it developed to detect potential violations, including information from domestic surveillance and outreach to foreign governments. In addition, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that FDA be given advance notice on shipments of imported food. FDA allows importers to provide this data no more than 30 days in advance of the date of arrival. This advance information helps FDA determine whether the food potentially poses a bioterrorism or other significant health risk such that FDA should deploy resources to the port of arrival so that an inspection can be conducted before the product enters the United States. FDA officials told us that this information has been so important in screening food shipments for potential violations that they are considering expanding

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prior notification requirements to all products the agency oversees. FSIS requires by regulation that various information accompany shipments of meat, poultry, and egg products in order to be considered for admission into the United States, including a foreign health certificate. As discussed earlier, while CPSC receives entry summary data regarding shipments already released into commerce, CPSC does not receive data on incoming shipments prior to their arrival at U.S. ports of entry, though CBP receives such data as much as 24 hours before the shipment is loaded in the foreign port. Without advance shipment data, CPSC lacks information that other agencies have found useful in screening incoming shipments for potential safety violations. FDA and USDA have significantly more staff supporting border operations than CPSC. Federal agencies assign staff resources to border operations to identify and refuse admission to potentially unsafe imported products. NHTSA has no staff dedicated to border operations, but instead relies on CBP to screen incoming shipments and third-party laboratories to test pulled shipments. However, FDA, FSIS, and APHIS assign significantly more staff resources to border operations. According to FSIS officials, the agency physically examines 100 percent of meat, poultry, and egg product shipments presented for import with about 75 inspectors located at approximately 150 facilities near 35 border entry points. In addition, FSIS employed 20 import surveillance officers as of fiscal year 2009. APHIS officials told us 100 percent of plants and animals are inspected in cooperation with CBP. Because of the high percentage of shipments that are inspected, staff resources are accordingly greater. For example, about 1,800 port staff had been assigned to inspect fruit and plants at 139 ports of entry as of 2003. FDA examines approximately 1 percent of food presented for import and has requested about $382 million for fiscal year 2010 for activities that support import safety. This amount would fund approximately 700 staff supporting import examinations alone, including port operations, of which 78 percent would be field based. FDA personnel cover most ports of entry into the United States, including 297 ports in fiscal year 2008, but for the ports where FDA does not maintain a normal presence, it coordinates with CBP to ensure it is notified of relevant incoming shipments for which examination and/or sampling may take place. FDA‘s border inspection activities are supported by compliance programs for agency field staff to use in carrying out inspections, sample collections, and analyses, among other things. For food safety alone, there are approximately 25 compliance programs and 12 that cover different imported foods.64 While FDA, FSIS, and APHIS have significant resources devoted to the port and overseas activities, they still face significant challenges in ensuring that products entering the United States are safe for consumers. As discussed earlier, CPSC has 9 compliance investigators at seven ports of entry, as well as about 100 product safety investigators located across the United States who work episodically to support the import surveillance program. Although the missions of FDA, USDA, and CPSC differ, CPSC‘s staff resources supporting border surveillance are much less than the staff resources of these other agencies and may not be adequate to prevent unsafe products from entering the United States.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 23 FDA and USDA have more sophisticated information technology systems and analytical support to target potential risks at border entry points. FDA, FSIS, and APHIS invest significant resources in information technology systems that support border surveillance efforts. To oversee inspection of plants and animals, CBP created positions in each of its 20 district offices for agriculture liaisons. These liaisons not only advise CBP on border surveillance operations but also report back to APHIS on risks detected at the border for the purpose of expanding targeting operations. These liaisons have access to CBP‘s Automated Targeting System, a computer system that stores detailed information from cargo manifests and other documents that shipping companies are required to provide before shipments arrive at ports for inspection.65 This system allows border staff to focus inspections on higher risk cargo. FSIS invests substantially—nearly $1 billion—in data infrastructure systems to assist its border inspections by linking inspection data with other public health information that is designed for FSIS to quickly and accurately identify trends and vulnerabilities affecting meat, poultry, and egg products. In addition, FSIS has developed a centralized computer system—the Automated Import Information System (AIIS)— that links all ports and tracks prior inspection results from each country and each foreign establishment for use in generating the type of inspection required on incoming shipments.66 FDA also uses an electronic environment—Operational and Administrative System for Import Support (OASIS)—to screen shipments presented for entry for relative risks and for making entry or inspection decisions.67 OASIS links with other data systems within FDA to leverage the latest information relating to public health. Also, FDA staff manually enter criteria into OASIS from sources such as import alert documents so that products can be flagged as they enter U.S. customs territory for the appearance of violations. According to FDA officials, there are currently about 270 import alerts in effect.68 FDA officials also told us that the overseas audits and direct communication with foreign governments provide useful information in helping border surveillance agents make entry determination decisions. As discussed earlier, CPSC targets few products for border inspections and has not developed formal systems for assessing risks and providing port staff with risk management tools. Whereas border surveillance efforts are geared toward intercepting potentially unsafe products at U.S. borders, outreach activities focused overseas may prevent potentially unsafe products from being shipped to U.S. ports. To this end, FDA and USDA assign staff to permanent positions in foreign countries and send staff overseas on a temporary basis to conduct educational workshops, as well as to conduct audits and inspections. Furthermore, some agencies have established cooperative agreements with foreign agencies to facilitate product safety. FDA and APHIS overseas outreach efforts help inform agencies about unsafe products. APHIS has more than 80 people around the world working with foreign embassies on plant and animal health issues. FDA announced the opening of offices in three cities in China in November 2008, and it has also announced plans to place technical experts and inspectors in four other regions, including Europe, India, Latin America, and the Middle East.69 These staff would be supported by approximately 8 staff in FDA headquarters in the United States. In addition, FDA has plans to hire 20

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FDA and FSIS conduct temporary visits, audits, or investigations in foreign countries that help to build foreign awareness of U.S. product safety laws. FSIS conducts on-site audits of foreign manufacturers as part of its systems equivalence determinations of foreign countries‘ food safety systems. FDA officials told us that the audits and announced inspections it conducts of overseas manufacturers are very useful in training these manufacturers about U.S. standards. Furthermore, FDA has reported that it has engaged in a variety of efforts with foreign governments to build foreign capacity and provide technical assistance. For example, they report holding regional workshops in Peru and China, participating in a multilateral food safety meeting geared toward developing a rapid alert system, and auditing Chinese government inspectors during their review of 13 Chinese firms to detect drug residues in aquaculture products. As discussed earlier, CPSC does not conduct foreign inspections. However, CPSC staff have conducted visits to foreign manufacturing plants with the permission of the foreign government. CPSC also has plans for conducting three outreach and training events each for foreign government officials and foreign manufacturers in fiscal year 2010, but the agency is limited in its outreach efforts due to limited numbers of staff. FDA and FSIS have actively engaged with foreign governments on food safety. FDA has actively engaged with foreign governments to develop cooperative arrangements and agreements, including a substantial number of international government-togovernment agreements. FDA‘s Web site indicates a total of 63 MOUs or other cooperative agreements with about 25 different foreign countries.70 FSIS has also negotiated government-to-government agreements as part of the food safety system equivalency determination process. Specifically, some countries have negotiated alternative sanitary measures to obtain this certification. As of July 2009, CPSC has established MOUs for the purpose of consumer product safety with 16 foreign agencies, as discussed later, but this activity has occurred fairly recently and over the last few years.

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INFORMATION SHARING AND COOPERATION AMONG COUNTRIES PROVIDE WAY TO BRIDGE DIFFERENCES AND STRENGTHEN CPSC’S IMPLEMENTATION OF ITS AUTHORITIES, BUT CPSC LACKS A COMPREHENSIVE PLAN TO GUIDE ITS WORK Australia, Canada, the EU, Japan, and the United States have some similar authorities for consumer product safety, but institutional structures to implement these authorities vary from country to country, reflecting unique national approaches. Countries also share similar challenges—such as inconsistent laws and standards and ineffective cooperation and liaison among agencies involved in consumer product safety— and national governments‘ efforts to address import safety challenges have intensified in light of the growing volume of imports and recent consumer safety incidents. Among officials we interviewed, there is broad consensus that continued cooperation among governments, regulators and multilateral organizations can improve consumer product safety policy and enforcement consistency and, ultimately, the effectiveness of import safety frameworks. CPSC‘s Office of International Programs and Intergovernmental Affairs participates in numerous activities with other countries and multilateral organizations. However, CPSC does not have comprehensive plans to guide its work with these countries and multilateral organizations due to resource constraints and other priorities, according to CPSC officials.

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While Similarities in Import Safety Authorities and Challenges Exist among Certain Countries, Their Institutional Structures and Implementation Reflect Unique National Approaches Import safety authorities in Australia, Canada, the EU, Japan, and the United States reflect certain shared values and experiences. According to the OECD, a fundamental objective of consumer product safety policy is to prevent consumers from suffering harm as a consequence of using products that present an unreasonable risk of injury. While these countries have similar authorities, however, the implementation of those authorities may be different. For example, all the countries monitor both domestically manufactured and imported products, and all conduct some type of product testing and/or sampling. However, some of the countries monitor goods on their own initiative, while others operate on the basis of complaints that they receive about particular goods and products. According to the officials representing the countries we reviewed, none of those countries has the authority to conduct an extraterritorial inspection of the facilities of a foreign manufacturer that exports products to that country. In most cases, these officials stated that the countries have been more successful in working with the exporting country and its manufacturers in order to correct problems that may arise. These officials also stated that none of the countries we reviewed has the authority to require foreign manufacturers to consent to local jurisdiction. U.S. Embassy and Australian government officials indicated that, under current law, Australia could ask foreign jurisdictions to enforce Australian consumer product safety laws; however, the Australian government prefers other methods, such as approaching manufacturers directly to raise safety concerns.

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The approach countries take to consumer product safety begins fundamentally with how they define ―safe‖ and ―unsafe‖ products. The definitions vary considerably from country to country, as indicated in appendix IV. According to a report by the OECD, most countries apply broad principles to determine whether a product can be defined as safe.71 For example, according to this report, in some countries (Japan, the United States, and the EU) all products must meet a positive standard— that is, they should be safe for consumers to use or consume prior to market distribution. Businesses selling unsafe goods may be subject to regulatory action, regardless of whether the product has caused a specific accident, injury, or harm to a consumer. In other countries (Australia and Canada), according to the OECD report, products must not breach a negative standard—that is, once the goods are placed on the market they should not carry an unreasonable risk of injury or death. The report notes that producers are held liable for the negative effects of their products once placed on the market. According to officials, some variations exist with other authorities. They noted that in most of the countries we reviewed only a relatively small number of imported consumer products are subject to mandatory standards. However, according to a senior representative of an industrial association in Europe, the wide variety of product standards among countries, combined with variable concepts and legal interpretations applied by governments makes it difficult for industry to ensure safety and for countries to coordinate enforcement efforts. There are also differences in the case of product certification. Officials stated that neither Australia nor Canada requires certification for imported products. According to Japanese government officials, certain imported and domestic products in Japan are subject to product testing and cannot be sold in Japan without certification to prescribed standards. In the EU, according to official documentation, businesses must carry out conformity and safety assessments of their products in accordance with the General Product Safety Directive (GPSD),72 and businesses are required to certify that their products are safe, as defined under GPSD. The documentation indicates that for some products self-declaration is sufficient, but other products require third-party verification. According to the OECD report on consumer product safety, institutional structures for product safety can also vary from country to country, which can sometimes create challenges for coordination within and among countries and, in many cases, accounts for differences in enforcement and implementation of authorities. The report states that in Canada, consumer product safety policy, development, enforcement, information, and education functions are in one organization, Health Canada, with the provinces retaining some enforcement responsibilities. In the United States, CPSC is the primary agency responsible for implementing and enforcing federal consumer product safety laws and establishing consumer product safety policy. The OECD report further notes that some countries have institutional arrangements that separate policy and enforcement functions. In Japan, for example, policy responsibility is spread across the government in a range of departments, with a central coordinating function in a central policy agency (the Cabinet Office). Certain other countries, such as Australia, have regionally focused policy and enforcement structures for consumer product safety that reflect a division of powers and responsibilities between the national government and states, provinces or regions. In the EU, policy responsibilities lie with the European Commission, the executive arm of the EU responsible for defining and implementing its policies and running its programs. However, individual EU member countries are responsible in their respective territories for enforcement—market surveillance, product monitoring and testing, and possible restrictive or corrective actions.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 27 Countries also share similar challenges as they respond to changing demands in the international market place. Similar to the United States, national governments‘ efforts to address import safety problems have intensified in light of the growing volume of imports entering each country and recent consumer safety incidents. According to the OECD report, many countries face enforcement challenges at both domestic and international levels, including finite resources; inconsistent laws, regulations, standards, and sanctions within countries and across borders; ineffective cooperation and liaison among agencies involved in consumer product safety enforcement; and insufficient sharing of injury information across borders. Governments have taken a variety of actions to address these challenges, including enacting new laws and regulations and, in some cases, they have created new organizations to address new consumer safety challenges. See appendix IV for more information.

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Engagement among Countries Provides Ways to Address Shared Import Safety Challenges Officials in Australia, Canada, the EU, Japan and the United States indicate that a mix of bilateral (country-to-country) and multilateral (involving multiple countries) exchanges and agreements among importing and exporting countries has been useful in addressing import safety challenges. The CPSC and its counterparts in other countries have taken a particularly active role in engaging China on consumer safety issues to create more transparent and cooperative relationships. According to the OECD‘s 2008 Report on Consumer Product Safety, bilateral engagement helps facilitate an exchange of information regarding consumer product safety issues and provides a mechanism for coordinated action against unsafe products. In the United States, CPSC‘s Office of International Programs and Intergovernmental Affairs administers MOUs between CPSC and consumer product safety entities in other countries, maintains regular contact with key exporting countries, and attends meetings and discussions sponsored by multilateral organizations. According to CPSC, as of June 2009, the office had established MOUs for the purpose of consumer product safety with 16 foreign agencies in Brazil, Canada, China, the EU, Israel, South Korea, Peru, Chile, Costa Rica, India, Japan, Mexico, Taiwan, Egypt, Columbia, and Vietnam. CPSC‘s Office of International Programs also conducts training sessions in various countries to explain U.S. import safety processes and procedures. According to CPSC, staff hold monthly teleconferences with the agency‘s counterparts in Canada, China, and the EU, and every two months CPSC holds a three-way teleconference with Mexico and China to provide additional opportunities for engagement. In 2008, CPSC created a Chinese-language page on the CPSC Web site and, not long after, a Vietnamese-language page to help facilitate information sharing. The pages provide information about U.S. product safety requirements, including relevant regulations and

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standards for products bound for the U.S. market, as well as information about the new CPSIA. Over the last few years, CPSC has increased its bilateral engagement with China. According to CPSC, the first U.S.-China Product Safety Summit was held in Beijing in 2005 and culminated in a joint Action Plan on Consumer Product Safety. CPSC and its counterpart in China, the General Administration for Quality Supervision, Inspection, and Quarantine (AQSIQ), established four working groups focused on fireworks, toys, lighters, and electrical products. According to CPSC, a third summit will be held in October 2009 and will build on the previous two, with the goal of institutionalizing a culture of product safety among Chinese consumer product manufacturers and exporters. In 2005, CPSC established a China Program Plan as a way of managing CPSC‘s various China-related activities and as the basis for an overall strategy to promote the safety and compliance of Chinese consumer products exported to the United States. Although the plan is to be updated on an annual basis to account for changing conditions and new opportunities for progress, CPSC has not updated the China Program Plan since 2007. According to a senior CPSC official, the fiscal year 2008 and 2009 plans were essentially the same as the 2007 plan. He stated, however, that a revised China Program Plan for 2010 will be submitted to the reconstituted commission and will be published when approved. Other countries have also established bilateral agreements with China. The European Commission engages in international contacts and cooperation and has, for instance, agreed on a Memorandum of Understanding with China's AQSIQ.73 According to the EU, one of the key initiatives launched by the EU and China has involved the RAPEX system, the EU‘s Rapid Alert System for nonfood consumer products.74 In May 2006, according to EU documentation, the European Commission decided to provide China‘s AQSIQ with access to the RAPEX system—specifically its notifications on products coming from China. EU officials report that China agreed to investigate all reported cases of dangerous products of Chinese origin and report back to the EU on the results, including withdrawals of export license and other corrective actions.75 Also, EU officials state that certain individual EU Member States have established limited bilateral contacts with China. According to Health Canada, Canada signed an agreement with China on import safety in 2007. A summit between China, the EU, and the United States occurred in November 2008 to strengthen consumer product safety trilateral cooperation, according to U.S. and EU documents. As a key exporting nation, China has revised some of its own laws, regulations, and procedures in response to high- profile recalls of Chinese-made goods and the consequent international engagement on these issues, according to a senior CPSC official. He indicated that an example of such a change occurred in March 2009, when the Chinese National Institute of Standardization approved Administrative Guidelines for Safe Consumer Product Manufacturing that emphasizes the role of manufacturers in ensuring consumer product safety. In addition, the CPSC official stated that China‘s AQSIQ had reported to CPSC that it has increased significantly the inspection of paint on export toys and closed down many factories that failed to implement a government requirement of selecting paint suppliers for toys only from a government- approved list. Multilateral engagement on consumer product safety issues provides other ways to encourage sharing of information and lessons learned on consumer product safety among a larger group of nations. Organizations such as OECD, the Asia-Pacific Economic Cooperation (APEC), and the International Consumer Product Safety Caucus provide

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additional frameworks for cooperation. U.S. and other officials believe that continued cooperation and coordination among governments and regulators can improve policy consistency and enforcement and, ultimately, the effectiveness of consumer product safety frameworks, particularly since consumer safety enforcement challenges are shared by most nations. On October 23, 2008, the OECD‘s Committee on Consumer Policy hosted its first Roundtable on International Consumer Product Safety, with an aim to examine consumer product safety trends and challenges at both domestic and international levels. The Director of CPSC‘s Office of International Programs and Intergovernmental Affairs attended this meeting, as did other OECD member nation representatives. The final report identified a number of key issues shared by member nations and initiatives for the future.76 CPSC representatives have also participated in APEC discussions concerning consumer product safety. In 2007, APEC leaders agreed on the need to develop a more robust approach to strengthening food and consumer product safety standards and practices in the region, using scientific, risk-based approaches and without creating unnecessary impediments to trade, according to APEC documents. APEC members reconvened in 2009 to determine future work on consumer product safety. CPSC‘s Chairman and three staff participated in an APEC regulators‘ dialogue on toy safety in August 2009 in Singapore aimed at strengthening information exchange among APEC members‘ product safety officials. The International Consumer Product Safety Caucus is another platform that facilitates the exchange of information on consumer product safety issues in the area of governmental policy, legislation and market surveillance, with a view to strengthening collaboration and cooperation among governments and regulatory agencies around the world. Current active members include Australia, Canada, China, the EU, Korea, Japan, and the United States (represented by CPSC). The caucus meets at least twice a year.

CPSC Has Not Developed Long-term Plans for International Activities While CPSC participates in numerous activities with other countries and multilateral organizations to establish and strengthen coordinated actions against unsafe consumer products, and has established MOUs with 16 foreign agencies for this purpose, CPSC does not have plans covering its work with these countries and multilateral organizations—except for China. According to CPSC, this is due to resource limitations in CPSC‘s Office of International Programs and Intergovernmental Affairs (as discussed earlier, the office has four staff) and because of its focus on China as the single largest source of foreign-made products. A senior CPSC official stated that with the creation of an additional staff position in the Office of International Programs, the office plans to expand its program planning to better address other countries. However, without a long-term plan that incorporates all the office‘s activities, it is difficult to accurately assess current and future resource needs and take best advantage of opportunities for future coordination and cooperation among importing and exporting nations that CPSC considers integral to preventing the entry of unsafe products. Long-term planning is particularly important for CPSC‘s Office of International Programs and Intergovernmental Affairs because of the diverse nature of its responsibilities and to ensure consistency in CPSC‘s policies.

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CPSC HAS ESTABLISHED ANNUAL GOALS AND SHORT-TERM PLANS TO PREVENT THE ENTRY OF UNSAFE PRODUCTS, BUT LACKS A LONG-TERM PLAN FOR THE FUTURE CPSC has established annual goals and short-term plans to prevent the entry of unsafe products but lacks a long-term plan to address the agency‘s growing role in import safety. Without a long-term plan, CPSC is not fully prepared to use new authorities granted in CPSIA, nor is it able to effectively address the safety of imported products through international means or to appropriately allocate any potential increases in agency resources.

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CPSC Has Established Short-term Plans and Annual Goals for Import Safety In May 2009, CPSC submitted a 2010 Performance Budget Request to Congress, which contains a section called the Import Safety Initiative. This initiative has three key principles: (1) assure that product safety is built into manufacturing and distribution processes from the start, (2) increase enforcement at the border to stop dangerous goods from entering the country, and (3) enhance surveillance of the marketplace to remove unsafe products from store shelves. These three principles are consistent with principles established on a governmentwide basis in 2007. In particular, the principles are consistent with those established by the Interagency Working Group on Import Safety, of which CPSC was a part.77 The working group issued an Action Plan for Import Safety in November 2007 that established three organizing principles: (1) prevention, which means to prevent harm in the first place by working with the private sector and foreign governments to adopt an approach to import safety that builds safety into manufacturing and distribution processes; (2) intervention, which means to act swiftly and in a coordinated manner when problems are discovered to seize, destroy, or otherwise prevent dangerous goods from advancing beyond the point of entry; and (3) response, which means to take swift action to limit potential exposure and harm to the American public in the event an unsafe import makes its way into domestic commerce. As part of the governmentwide strategy, CPSC developed its Import Safety Initiative, which contains annual goals that are consistent with the initiative‘s key principles, but it is a short-term plan. For example, to help assure that product safety is built into manufacturing and distribution processes from the start, CSPC states that it plans to conduct three outreach and training events for foreign government officials in 2010 and three outreach and training events for foreign manufacturers. CPSC also has a short-term plan for how it will manage its various China-related activities and states that, for 2010, staff will review and update this plan. To increase enforcement at the border, CPSC states that it plans to increase the number of full-time staff working at U.S. ports and to increase the number of sample products screened at the ports. CPSC‘s Import Safety Initiative also links goals to requests for increased resources. For example, CPSC states that, with increased resources, it plans to increase its presence at U.S. ports of entry and open its first overseas office in Beijing, China. CPSC officials have described to us other short-term plans that they developed to respond to requirements and authorizations in CPSIA. For example, as discussed earlier in this report,

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 31 CPSC‘s decision to assign additional full-time staff to ports responds to Section 202 of CPSIA, which requires CPSC to hire personnel to be assigned to duty stations at U.S. ports of entry, or to inspect overseas manufacturing facilities, subject to the availability of appropriations. In its Import Safety Initiative, CPSC requests funding for 10 additional staff to be assigned to ports in 2010. A CPSC official with whom we spoke said that he expects the number of staff assigned to ports to grow from its current level of 9 to about 50 over the next few years. However, CPSC has conducted limited analyses of how it plans to assign additional staff to ports in the coming years, and standard operating procedures that describe compliance investigators‘ roles and responsibilities at ports of entry have not been updated since 1989. CPSC officials acknowledged the need to update these procedures. CPSIA also requires CPSC, as discussed earlier in this report, to develop a methodology for identifying shipments of imported consumer products that are likely to violate import provisions enforced by CPSC due by August 2010. CPSC, as noted earlier, has taken steps to develop a plan for sharing information and coordinating with CBP, but it is unlikely that CPSC will complete this plan by August 2009, as required under CPSIA, because of delays in updating its agreements with CBP.

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CPSC Has Recognized the Need for U.S. Consumer Product Safety Policy to Comply with WTO Obligations and International Trade Agreements In undertaking its planning efforts, CPSC has recognized the need for U.S. consumer product safety policy to comply with World Trade Organization (WTO) obligations and international trade agreements—a positive recognition on CPSC‘s part. A CPSC official involved in international education and outreach activities said that, in working to address U.S. concerns about the safety of imported products, it is also critical to comply with WTO rules. The official said there are statutory requirements—namely, the Trade Act of 1979— mandating U.S. standards for complying with international trade agreements. He said that CPSC has had a productive working relationship with USTR in the past, and that CPSC is looking to formalize its working relationship with USTR in the future by developing internal standard operating procedures for consulting with USTR. The official said that the procedures would be useful to CPSC in identifying issues that should have USTR‘s input before they are finalized. CPSC has also recognized the importance of international trade agreements through its work with international groups, such as OECD, as discussed previously in this report. In particular, CPSC has recognized that the WTO Agreements on Technical Barriers to Trade— which establishes rules for preparing, adopting, and applying technical regulations, standards, and conformity assessment procedures—serves to encourage uniformity and predictability in national consumer product safety regimes.

CPSC Lacks a Long-term Plan to Prevent the Entry of Unsafe Products Although CPSC has established short-term plans and annual goals to prevent the entry of unsafe products, the agency has not developed a long-term plan for addressing its import safety work. In particular, CPSC has not updated its agencywide Strategic Plan, which was

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issued in 2003 and was due for revision in 2006. According to the Government Performance and Results Act, strategic plans help agencies establish long-term goals, including identifying the resources needed to accomplish these goals. The act calls for federal agencies to develop multiyear strategic plans and update them at least every 3 years. CPSC‘s Strategic Plan does not reflect its import safety work, its plans for international education and outreach activities, its plans to use new authorities granted in CPSIA to prevent the entry of unsafe products, or its plans to respond to mandates in CPSIA to improve its risk assessment and coordination with CBP. CPSC has recently begun efforts to update its Strategic Plan by requesting public comments on revisions to the plan.78 In addition to lacking a long-term plan to prevent the entry of unsafe products, CPSC does not have outcome-oriented performance measures to assess the effectiveness of its import safety work. One of CPSC‘s goals for 2010 is to develop measures of import safety success, according to CPSC‘s Import Safety Initiative. CPSC reports that, in 2008, staff researched and evaluated information for an enhanced surveillance system, making contact with FDA, CBP, and Internal Revenue Service staff to discuss methods and requirements of their systems. As discussed earlier in this report, CPSC has also requested public input concerning the development of consumer product safety metrics, but it received only two responses, neither of which addressed CPSC‘s need for developing new performance measures.79 CPSC has established short-terms plans and annual goals for its import safety work, but it does not have goals for these activities beyond 2010. Without a long-term plan for import safety that contains key goals and performance measures, CPSC may be unable to replicate or enhance its short-term efforts over the longer term. For example, CPSC may find insufficient staff to cover meetings and seminars needed to work with foreign governments and foreign manufacturers over the long-term to build product safety into manufacturing and distribution processes from the start. CPSC may also find it difficult to analyze any data it collects through surveillance of the marketplace to strengthen and improve its targeting decisions at the ports. Finally, CPSC may face challenges in ensuring that any further resources it devotes to increasing its port staff and operations are also accompanied by appropriate growth in its analytical and other support staff to help ensure a comprehensive and balanced approach to product safety.

CONCLUSIONS Broad agreement exists among CPSC staff, legal experts, industry representatives, and consumer advocates that CPSC‘s authorities to prevent the entry of unsafe products into the United States have the potential to be effective, but only if they are implemented more fully. With delays in some rulemakings, such as testing and certification requirements, it remains unclear whether CPSC will be able to implement its authorities effectively. Furthermore, CPSC faces significant challenges due to competing priorities and resource constraints. CPSC has taken positive steps to shift its approach to import product safety from one focused on responding to problems after products have entered the marketplace to an approach focused on preventing harmful products from ever reaching consumers. To implement this preventive approach, CPSC states that it is taking steps to enhance surveillance activities, increase

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 33 enforcement at the ports, engage foreign governments, and educate foreign manufacturers on U.S. standards for consumer product safety. Our work demonstrates that CPSC needs to strengthen its surveillance activities, particularly its ability to target potentially unsafe products for further screening and review at U.S. ports. CPSC has yet to obtain access to advance shipment data, which FDA‘s experience suggests could be useful in targeting incoming shipments. In addition, CPSC‘s agreements with CBP are outdated, which hinders CPSC and CBP‘s ability to target imports under CPSC‘s jurisdiction. CPSIA requires that CPSC and CBP work together to develop a methodology to assess the risks of various imported products and to cooperate on CPSC‘s participation in a CBP targeting center. These joint efforts are a key element for improving CPSC‘s ability to target shipments for screening and review at the ports and to ensuring consistent enforcement of CPSC‘s authorities across the United States. Because CPSC relies heavily on CBP for enforcement at the ports, it is imperative for CPSC and CBP to resolve issues concerning their agreements for sharing information and update their procedures for operating at the port. CPSC‘s targeting efforts could be strengthened further through expanded engagement with foreign governments and education of foreign manufacturers on U.S. consumer product safety standards. Such outreach could inform industry of its responsibility for the safety of consumer products entering the United States and provide CPSC with information on manufacturing in the respective countries to assist the agency‘s development of a risk assessment methodology for imported products. Without improving its ability to target potential risks across a broad range of product categories, it is unclear how CPSC will succeed in preventing unsafe consumer products from entering the United States. CPSC‘s inspection of foreign manufacturing plants faces practical constraints and would likely require tremendous resources to implement. CPSC believes strong cooperative relationships between countries to build strong frameworks for consumer product safety are a more effective approach for the United States. As part of its approach, CPSC is in the process of developing such relationships, and current MOUs between CPSC and certain foreign countries primarily address information sharing. CPSC officials state that expanding CPSC‘s education and outreach rather than inspection of foreign plants could serve to more effectively prevent the entry of unsafe consumer products. Similarly, officials from the U.S. agencies, with the exception of FDA, and countries we reviewed, stated that they do not conduct inspections of foreign manufacturing plants. In most cases, officials we interviewed stated that the countries have been more successful in working with exporters in order to correct problems that may arise. Therefore, we are not recommending any additional authorities be granted to CPSC at this time. Efforts to expand U.S. jurisdiction to foreign manufacturers for purposes of enforcement action also present unique practical considerations. It may be argued that if foreign manufacturers were required to consent to U.S. jurisdiction, CPSC‘s enforcement ability would be strengthened because CPSC would have one less hurdle to overcome in pursuing enforcement actions. Nevertheless, CPSC staff stated that, at this time, CPSC does not see the need for this requirement in order to effectively carry out its enforcement duties. To date, CPSC has been able to satisfy its enforcement objectives by pursuing the domestic partners— broadly defined to include those companies along the supply chain to the retailer—associated with the foreign manufacturer. CPSC also has the ability to settle enforcement actions with foreign parties. FDA and USDA officials have found that their efforts to educate overseas industry and governments on U.S. safety standards and the particular risks being screened for

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at the border could reduce the number of unsafe products that reach U.S. consumers. Similarly, CPSC staff we interviewed stated that expanded international education and outreach, rather than expanded enforcement jurisdiction, would more effectively prevent the entry of unsafe products, although they acknowledged that consent to jurisdiction or a requirement of a U.S. agent for service of process would be helpful. Due to the practical considerations associated with requiring foreign manufacturers to consent to U.S. jurisdiction for purposes of CPSC enforcement actions, we make no recommendations for additional CPSC authorities at this time. CPSC‘s short-term plans to prevent the entry of unsafe products are consistent with a governmentwide approach taken by the Interagency Working Group on Import Safety in 2007. That group, of which CPSC was a part, established three organizing principles— prevention, intervention, and response—that represent, in our view, a comprehensive approach to import safety. However, CPSC lacks a long-term plan to prevent the entry of unsafe products. CPSC has not updated its September 2003 Strategic Plan, even though the Government Performance and Results Act requires this plan to be updated at least every 3 years. Although CPSC has initiated steps to update its Strategic Plan by requesting public comments, it is important for CPSC to work expeditiously to follow through on its efforts. In addition, while CPSC recognizes the need for outcome-oriented performance measures and has taken steps to develop new measures, it does not currently have such measures in place for its import safety work. Without a long-term plan that contains key goals and measures, CPSC may find it difficult to address its challenges in implementing the new authorities granted in CPSIA to prevent the entry of unsafe products, such as decisions about where and how to allocate any future increases in agency resources.

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RECOMMENDATIONS FOR EXECUTIVE ACTION First, to ensure that CPSC is able to exercise its full authority to prevent the entry of unsafe consumer products into the United States, we recommend that CPSC ensure expeditious implementation of key provisions of CPSIA, including establishing the substantial product hazard list and implementing testing and certification requirements that are subject to stay of enforcement until February 2010, and complete its rulemaking as required under the act. Second, to strengthen CPSC‘s ability to prevent the entry of unsafe products into the United States, we recommend that the Chairman and commissioners of CPSC take several actions to improve the agency‘s ability to target shipments for further screening and review at U.S. ports of entry as follows: 1. To ensure that it has appropriate data and procedures to prevent entry of unsafe products into the United States, we recommend that CPSC update agreements with CBP to clarify each agency‘s roles and to resolve issues for obtaining access to advance shipment data; and 2. To improve its targeting decisions and build its risk-analysis capability, we recommend that CPSC

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work with CBP, as directed under CPSIA through the planned targeting center for health and safety issues, to develop the capacity to analyze advance shipment data; and b. link data CPSC gathers from surveillance activities and from international education and outreach activities to further target incoming shipments. Third, to provide better long-term planning for its import safety work and to account for new authorities granted in CPSIA, we recommend that CPSC expeditiously update its agencywide Strategic Plan. In updating its Strategic Plan, we recommend that CPSC consider the impact of its enhanced surveillance of the marketplace and at U.S. ports as discussed above and determine whether requisite analytical and laboratory staff are in place to support any increased activity that may occur at U.S. ports. Furthermore, we recommend that CPSC‘s Strategic Plan include a comprehensive plan for the Office of International Programs and Intergovernmental Affairs to work with foreign governments in bilateral and multilateral environments to 1. educate foreign manufacturers about U.S. product safety standards and best practices, and 2. coordinate on development of effective international frameworks for consumer product safety.

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AGENCY COMMENTS AND OUR EVALUATION We provided a draft of this report to CPSC, CBP, USTR, and the Departments of Agriculture; Commerce; Health and Human Services; State; and Transportation; and to EU and Canadian officials for review and comment. CPSC, CBP, USTR, Agriculture, Health and Human Services, Transportation, and EU and Canadian officials provided technical comments, which we incorporated as appropriate. CPSC stated that it concurs with our recommendations.

Alicia Puente Cackley Director, Financial Markets and Community Investment

APPENDIX I. OBJECTIVES, SCOPE, AND METHODOLOGY To determine the effectiveness of the Consumer Product Safety Commission‘s (CPSC) import safety authorities, we examined CPSC data and interviewed CPSC officials to learn how the agency measures and assesses its own effectiveness. We also conducted extensive document reviews on consumer product safety generally and import safety specifically. We interviewed legal professionals and consumer and industry representatives to obtain their

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perspective on the effectiveness of CPSC‘s authorities. We also interviewed officials from other federal agencies involved in imported product safety, including U.S. Customs and Border Protection (CBP), the Office of the United States Trade Representative (USTR), and the Departments of State and Commerce. We visited a U.S. port of entry to observe CPSC import surveillance activities and CPSC‘s interaction with staff from CBP. We also visited CPSC‘s Product Testing Laboratory in Gaithersburg, Maryland, to observe laboratory testing that supports import safety activities. To compare CPSC‘s authorities with respect to the safety of imported products with the authorities of select federal agencies, we identified key federal agencies with import regulatory authority over other types of consumer goods. These agencies are the Food and Drug Administration (FDA), which oversees the safety of imported food, drugs, cosmetics, and medical devices; the United States Department of Agriculture‘s (USDA) Food Safety and Inspection Service (FSIS), which oversees the safety of imported egg products, meat and poultry; USDA‘s Animal Plant Health Inspection Service (APHIS), which oversees the safety of imported plants and animals; and the National Highway Traffic Safety Administration (NHTSA), which oversees the safety of imported motor vehicles and equipment. We interviewed officials from each of these agencies, had them identify the primary statutory authorities for ensuring the safety of imports under their jurisdiction, and discussed various agency activities supporting import safety. For FDA, the primary statutory authority is the Federal Food, Drug, and Cosmetic Act. For USDA, the primary statutory authorities are the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, the Animal Health Protection Act, and the Plant Protection Act. For NHTSA, the primary statutory authority is the National Traffic and Motor Vehicle Safety Act, which has been classified, as amended, at Subtitle VI of Title 49 of the U.S. Code. For our comparative analysis of the product safety authorities of foreign countries, we selected countries that are members of the International Consumer Product Safety Caucus, which is an international forum consisting of product safety officials from member governments to facilitate the exchange of information on consumer product safety. Specifically, we selected Australia, Canada, China, the European Union (EU), and Japan.80 We developed a set of questions concerning consumer product safety authorities, practices, and procedures and worked through the U.S. Department of State to distribute the questions to appropriate contacts at U.S. embassies overseas and, in some cases, to foreign embassies in Washington, D.C. We interviewed desk officers for the selected countries from the Departments of State and Commerce in Washington, D.C., and relied on the Department of State to advise us on the recommended approach to take with each country. We reviewed foreign laws and regulations, as well as other documents regarding product safety, provided by U.S. Embassy officials in the selected countries. We did not independently analyze the laws, regulations, or procedures of these countries; instead, we relied on third-party assessments of each country‘s consumer product safety framework. We received written responses to our questions from and conducted interviews with the U.S. embassies in Australia, Canada, and China. U.S. embassy officials told us that their responses were coordinated with country officials knowledgeable of the respective country‘s laws, regulations, and procedures. We received written responses to our questions from officials with the Embassy of Japan in Washington, D.C. We received written answers to our questions from consumer product safety officials in the EU. We also received information from the supreme audit institutions in these countries regarding their work on consumer product safety.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 37 We conducted interviews with consumer product safety officials from Canada, the EU, and Japan at a conference of the International Consumer Product Health and Safety Organization (ICPHSO) in Orlando, Florida. We reviewed publicly available documents on the Web sites of consumer product safety agencies in each country. We also reviewed and utilized documents provided by the Organization for Economic Cooperation and Development (OECD), including OECD member country responses to a 2008 questionnaire concerning consumer product safety. Department of State officials reviewed a draft of our country summaries and provided comments, which we incorporated. To evaluate CPSC‘s plans to prevent the entry of unsafe products in the future, we reviewed CPSC‘s 2010 Performance Budget Request and compared CPSC‘s planning efforts to guidance GAO has developed for implementation of the Government Performance and Results Act. We examined other CPSC data and interviewed CPSC officials to learn about CPSC‘s future plans. We also interviewed legal professionals and consumer and industry representatives to obtain their perspectives on CPSC‘s future plans. We conducted this performance audit from September 2008 to August 2009, in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

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APPENDIX II. PERSONAL JURISDICTION OVER FOREIGN MANUFACTURERS FOR CPSC ENFORCEMENT PURPOSES The Consumer Product Safety Improvement Act contained a mandate requiring that GAO make a recommendation as to whether foreign manufacturers should be required to consent to the jurisdiction of U.S. courts with respect to enforcement actions by the commission. We raised this issue in our interviews with officials at the Consumer Product Safety Commission (CPSC), the United States Department of Agriculture, the Food and Drug Administration, and the National Highway Traffic Safety Administration, as well as officials representing most of the international entities we selected for study—Australia, Canada, the European Union, and Japan. CPSC staff stated that, at this time, CPSC does not see the need for this requirement in order to effectively carry out its enforcement duties. CPSC has authority to institute administrative or civil enforcement actions against manufacturers, distributors, importers, and retailers. CPSC may opt to negotiate a settlement or consent agreement rather than instituting an adjudicative proceeding in a federal or administrative court. Enforcing product safety standards on foreign manufacturers through an adjudicative proceeding could theoretically pose practical challenges. For example, one important prerequisite to maintaining an action against any defendant in a U.S. state, federal, or administrative court is that the court must have the ability to exert personal jurisdiction over that party.81 A court‘s exercise of personal jurisdiction over a party must satisfy the fundamental notions of fairness mandated by the Due Process Clause of the Fifth or Fourteenth Amendments. In the case of a defendant physically located outside the territorial jurisdiction, such as a foreign manufacturer, personal jurisdiction can be established if

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sufficient contacts exist between a defendant and the territorial jurisdiction where the court sits, and the defendant receives fair notice of the suit. Both requirements are fact-specific and must ultimately be decided by a court, if challenged by the defendant. By requiring foreign manufacturers to consent to U.S. jurisdiction for purposes of CPSC enforcement actions, CPSC‘s enforcement process could possibly be expedited in that it would eliminate a personal jurisdictional challenge to the enforcement action. However, as noted above, CSPC did not see a need to take such action at this time. CPSC noted that it can pursue each of the actors in the supply chain, from the manufacturer to the retailer, foreign or domestic. Despite the challenges that could theoretically arise in instituting an enforcement action against a foreign actor, to date, pursuing the domestic partners of such actors has satisfied CPSC‘s enforcement objectives.82 Further, CSPC has the ability to settle enforcement actions with foreign parties. In the event a settlement cannot be reached voluntarily, any formal action against a foreign corporation must be served following the Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters (―Convention‖).83 CPSC also has the authority to file suit against a foreign manufacturer for civil penalties for violations of certain provisions of its statutes, if it can effect service by the Convention or otherwise, and establish that the court has jurisdiction. For example, the Department of Justice on behalf of CPSC recently filed suit against a foreign manufacturer in the U.S. District Court for the District of Minnesota, which was settled in July 2009.84 CPSC staff we interviewed believe that expanded international education and outreach programs, as opposed to requiring foreign manufacturers to consent to jurisdiction, are preferable tools to effectively prevent the entry of unsafe consumer products, although they acknowledged that consent to jurisdiction or a requirement of a U.S. agent for service of process would be helpful. In addition, each of the U.S. federal agencies and international entities that we interviewed stated that they do not require consent by foreign manufacturers to local jurisdiction with respect to enforcement actions. Therefore, we are not recommending any action at this time.

APPENDIX III. KEY AUTHORITIES OF SELECT FEDERAL AGENCIES We compared the Consumer Product Safety Commission‘s (CPSC) key authorities for preventing the import of unsafe consumer products to those of three federal agencies—the Food and Drug Administration (FDA), the National Highway Traffic Safety Administration (NHTSA), and the United States Department of Agriculture (USDA). Table 1 describes some of the statutory and regulatory provisions of such agencies with respect to various regulatory activities, such as inspecting shipments that are presented for import into the United States.85 In acknowledgement of the ongoing efforts of the Interagency Working Group on Import Safety, in which these four agencies participate, we present these authorities according to the same principles that are the foundation of the group‘s strategic framework—prevention and intervention.86 Although the group uses a third principle—response—we generally did not evaluate agencies‘ authorities to respond after an unsafe import enters U.S. commerce because the scope of our work was limited to those authorities to prevent their entry.

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Table 1. Key Authorities of Select Federal Agencies for Preventing the Entry of Unsafe Imports

Product

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Primary statute

CPSC Consumer products

Consumer Product Safety Act, Pub. L. No. 92573, 86 Stat. 1207 (Oct. 27, 1972) (classified, as amended, at 15 U.S.C. §§ 2051 et seq.)c Federal Hazardous Substances Act, Pub. L. No. 86-61 3, 74 Stat. 372 (July 12, 1960) (classified, as amended, at 15 U.S.C. §§ 1261 et seq.) Flammable Fabrics Act, ch. 164, 67 Stat. 111 (Jun. 30, 1953) (classified, as amended, at 15 U.S.C. §§ 1191 et seq.)

Agency FDA Food (not including meat, poultry products, eggs, or egg products), drugs, and medical devicesb Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (Jun. 25, 1938) (classified, as amended, at 21 U.S.C. §§ 321 et seq.)

NHTSA Motor vehicles, motor vehicle equipment

USDAa Meat, poultry products, eggs, and egg products; live plants and animals

National Traffic and Motor Vehicle Safety Act, codified as amended, at Subtitle VI Title 49, of the U.S. Code (49 U.S.C. §§ 30101 et seq.)

Federal Meat Inspection Act, ch. 2907, 24 Stat. 1260 (Mar. 4, 1907) (classified, as amended, at 21 U.S.C. §§ 601 et seq.) Poultry Products Inspection Act, Pub. L. No. 85-1 72, 71 Stat. 441 (Aug. 28, 1957) (classified, as amended, at 21 U.S.C. §§ 451 et seq.) Egg Products Inspection Act, Pub. L. No. 91 -597, 84 Stat. 1620 (Dec. 29, 1970) (classified, as amended, at 21 U.S.C. §§ 1031 et seq.) Animal Health Protection Act, Pub. L. No. 107-171, Title X, Subtitle E, 116 Stat. 494 (May 13, 2002) (classified, as amended, at 7 U.S.C. §§ 8301 et seq.) Plant Protection Act, Pub. L. No. 106224, Title IV, 114 Stat. 438 (Jun. 20, 2000) (classified, as amended, at 7 U.S.C. §§ 7701 et seq.)

Prevention—Authorities to prevent the importation of unsafe products into the United States Preapproval, All manufacturers are Manufacturers are required Devices certification, and/or required to issue a certificate Certain devices are subject to to certify that vehicles and testing of imports prior of compliance with all premarket approval by FDA. equipment comply with to entry into the United applicable rules, bans, New drugsd No new drug applicable safety standards. States standards, or regulations. may be introduced into Such certifications may be, interstate commerce unless but are not required to be,

Eggs, egg products, poultry, and meat Products must be accompanied by a foreign inspection certificate that includes certain information and representations of the appropriate

Table 1. (Continued) Agency

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Inspection of facilities located in foreign countries

CPSC Certifications must be based on a test of each product or a reasonable testing program. With respect to certain children‘s products, such certification must be based on testing conducted by a third party that is accredited by CPSC. CPSC is authorized to inspect any factory, warehouse, or establishment in which consumer products are manufactured or held for distribution in the United States. CPSC is required, by rule, to condition the importation of any consumer product into the United States on the manufacturer‘s compliance with the inspection requirements of the Consumer Product Safety Act (CPSA).

FDA and until FDA has approved its new drug application. An application may be denied if the application does not include reports of adequate testing by all methods reasonably applicable to show whether or not the drug is safe for use. FDA is authorized to conduct inspections of establishments engaged in the manufacture of food, drugs, or devices offered for commercial distribution in the United States. For drugs and medical devices, at the request of FDA, the U.S. agent of the establishment is required to assist in scheduling inspections. In practice, if the foreign firm refuses to permit such an inspection, FDA can sometimes refuse admission of products offered for import into the U.S. For

NHTSA based on testing, and the results of any testing are not required to be reported to NHTSA as a condition for entry.

USDAa government official of the exporting country.e The inspection must be signed by the authorized foreign government official and, in some cases, bear the official seal of the foreign government agency responsible for inspection of the products. (See also, ―Labeling‖ below.)

No statutory provision expressly authorizes NHTSA to inspect facilities located in foreign countries.

Egg products, poultry, and meat Only products from establishments certified by eligible foreign countries are eligible for importation into the United States. In order to be an eligible country, the Food Safety and Inspection Service (FSIS) must determine that the foreign country (1) maintains an inspection system equivalent to that of the United States and (2) ensures compliance with such inspection system. In determining eligibility of a particular country, FSIS will conduct an initial review of the operation of the country‘s inspection system, and conduct periodic reviews thereafter. The eligibility of foreign establishments to continue to export products to the United States is subject to periodic

Table 1. (Continued) Agency

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CPSC

FDA example, the refusal to permit an inspection could lead to a product not receiving a required pre-market approval or the refusal to permit an inspection, combined with other information, could support a determination of the appearance of a violation. Intervention—Authorities to intercept unsafe goods before they enter U.S. commerce Product standards/ CPSC may promulgate Food and devices product bans mandatory product safety Applicable law sets forth the standards, as well as rules definitions for adulterated and declaring a product a banned misbranded food, drugs, and hazardous product. devices, including the Currently, there are 33 standards for manufacturing mandatory safety standards. practices. CPSC may also petition a U.S. District Court to declare a product an imminently hazardous consumer product and grant such relief as may be appropriate to protect the public, such as ordering a recall of the product or ordering the notification of such risk to the purchasers of the product.

NHTSA

USDAa review, including observations of the foreign establishments by FSIS. Live plants and animals APHIS may inspect plants and animals for export at international ports or other points of origin.

NHTSA may prescribe motor vehicle safety standards. Currently, there are 45 safety standards for vehicles and 15 safety standards for equipment.

Eggs, egg products, poultry, and meat FSIS regulates the sanitary operating practices of plants that slaughter or process poultry and meat and sets forth sanitary operating practices of plants that process egg products. Statutes set forth definitions of adulterated and misbranded meat, poultry, and egg products. Live plants and animals Statute prohibits the import of plants or animals that contain certain pests or diseases

Table 1. (Continued) Agency

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Labeling

Registration of foreign manufacturers/ facilities

CPSC CPSC may require permanent markings (e.g. labels) on products, where practicable, that identify the date and place of manufacture, as well as manufacturing cohort information, such as batch number.

FDA Food, drugs, and devices Products are subject to labeling requirements such as, depending on the product, its contents, and its proper use.

NHTSA Manufacturers affix to the motor vehicle or equipment, or to the equipment container, a label, tag, or marking that represents the required certification that the vehicle or equipment complies with applicable safety standards.

There is no statutory requirement for the registration of foreign manufacturers with CPSC.

Food A foreign establishment that engages in the manufacture, processing, packing or holding of food for export to the United States without further processing or packaging outside of the United States, must register with FDA and provide certain information, including a list of all trade names and the name of its U.S. agent.

Motor vehicles not certified to all applicable safety standards may only be imported by a person registered with NHTSA or by a person who has contracted with a registered importer.

USDAa Eggs, egg products, poultry, and meat The immediate containers of eggs and egg products must bear a label printed in English with certain information, including, for egg products, the inspection mark of the country of origin. The immediate containers of imported poultry and meat must bear labels that comply with the labeling requirements applicable to domestic products, except that the label will bear the name of the country of origin and the inspection mark and establishment number assigned by the foreign inspection system and certified to FSIS. There is no statutory requirement for registration of foreign establishments with USDA.

Table 1. (Continued) Agency

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CPSC

Preshipment/prearrival notification

No statutory provision expressly requires foreign manufacturers to provide preshipment notification to CPSC.

Border surveillance

CPSC is required to maintain a permanent product surveillance program to prevent the entry of unsafe consumer products into the United States, among other things.

FDA Drugs and devices A foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device offered for import into the United States must register with the FDA and provide a list of each drug offered for commercial distribution and the name of its U.S. agent. Food Food shipments presented for import must be preceded by prior notice to enable FDA to target food for inspection at ports of entry. Notification must identify the article, manufacturer, shipper, grower, country of origin, and anticipated port of entry. All products FDA may examine shipments and obtain samples of food, drugs, and devices presented for import to determine whether the product is subject to refusal of admission.

NHTSA

No statutory provision expressly requires foreign manufacturers to provide preshipment notification to NHTSA.

No statutory provision mandates a border surveillance program.

USDAa

Eggs, egg products, poultry, and meat Except for importers of Canadian meat products, importers must make an application for inspection at the port of entry. The application should be made as long as possible in advance of the anticipated arrival of the product to the United States. Importers of Canadian meat products are subject to streamlined inspection procedures. Eggs, egg products, poultry, and meat CBP notifies FSIS when products from restricted countries are presented for import into the United States. Live plants CBP is to notify APHIS of the arrival of any plant at a port of entry and is to

Table 1. (Continued) Agency

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Refusal at ports of entry

CPSC CPSC may inspect consumer products being offered for import. At CPSC‘s request, CBP will obtain a reasonable number of samples of such product for the purpose of making admissibility decisions.

FDA Also, authority provided to prioritize border food inspections, develop tests for the rapid detection of adulterated food, improve border computer systems, and improve links with other federal agencies responsible for food safety.

CPSC may refuse admission of any consumer product offered for import that fails to comply with an applicable mandatory safety standard or ban; has been determined to be an imminently hazardous consumer product; has a defect which constitutes a substantial product hazard;

All products Subject to an opportunity to introduce testimony, any food, drug, or device may be refused admission into the United States if it appears from an examination or otherwise that the product is adulterated or misbranded; is an unapproved new drug; is forbidden or restricted in sale in the exporting country; or

NHTSA

USDAa hold the item until it is inspected and authorized for entry or is otherwise released by APHIS. Live plants and animals APHIS may stop and inspect, without a warrant, any person or means of conveyance moving into the United States to determine whether it is carrying any plant or regulated animal. Also, authorities are provided to improve surveillance at ports of entry and customs and to implement a centralized automated recordkeeping system to better track the status of animal and plant shipments, including those on hold at ports of entry and customs. Eggs, egg products, poultry, and meat Eggs, egg products, poultry, and meat that are adulterated, misbranded, or do not comply with standards applicable to equivalent products in U.S. commerce shall not be imported. Live plants or animals APHIS may refuse admission to plants if determined necessary to prevent the spread of plant pests or noxious weeds in the United States.

Table 1. (Continued) Agency CPSC

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is not properly certified or labeled; or is manufactured by a manufacturer that has failed to comply with applicable recordkeeping and inspection requirements.

Detention/ seizure/ holds pending completion of inspection or further action by owner

CPSC may examine samples of products at ports of entry. CPSC statutes describe prohibited acts, which form the basis for it to instruct CBP to seize products under the Tariff Act authorities. CPSC may also decide to detain the shipment pending further examination and testing, conditionally release the shipment to the importer‘s premises pending

FDA has been manufactured or processed in unsan-itary conditions or out of conformance with good manufacturing practices. Food FDA may refuse a food shipment for which advance shipment information has not been provided or is from an unregistered foreign manufacturer. Drugs and devices FDA may refuse drugs or devices that are not accompanied by a registration of foreign supplier.

NHTSA

USDAa APHIS may refuse admission of any animal, article, or means of conveyance to prevent the introduction or spread of any pest or livestock disease in the United States.

All products Food, drugs, and devices are subject to inspection. The product remains in the custody of CBP, unless delivered to the owner or consignee under bond. Food FDA may request that a food article that appears to present a health threat be held for a period not to exceed 24 hours for the purpose of inspecting, examining, or investigating it. Food shipments that arrive

No statutory provision; however, NHTSA regulations provide that motor vehicles not in conformity with all applicable safety standards at the time of import may be admitted under a bond to ensure that the vehicle will either be brought into conformity within 120 days, returned to the custody of CBP for export, or abandoned to the United States.

Eggs, egg products, poultry, and meat Generally, eggs, egg products, poultry, and meat are subject to U.S. inspection at the port of entry and may not be removed from the port of entry prior to inspection. The product remains in the custody of CBP unless delivered to the consignee under an approved bond. FSIS may detain egg products, poultry, and meat for a period not to exceed 20 days. Live animals APHIS may require that any imported animal be raised or handled under

Table 1. (Continued) Agency CPSC examination and testing, or release the shipment to the importer outright.

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Product destruction

Products refused admission into the United States must be destroyed, unless CBP permits the product to be exported from the customs territory of the United States. All expenses connected with destruction must be paid by the owner or consignee. A failure to make such payment shall constitute a lien against future imports.

FDA without adequate prior notice or that are from unregistered foreign manufacturers may be held until prior notice or registration is completed. CBP may destroy any food, drug, or device that is refused admission, unless the article is exported within 90 days. All expenses connected to the destruction of refused goods shall be paid by the owner or consignee. A default shall constitute a lien against future imports.

NHTSA

There is no statutory provision regarding the destruction of nonconforming motor vehicles or equipment by NHTSA.

Response—Authorities to act on harm, real or potential, after products enter U.S. commerce

USDAa quarantine to determine whether it is affected by any pest or disease.

Egg products, poultry, and meat Egg products, poultry, and meat that violate federal requirements are destroyed at the expense of the owner or cosignee, unless they are exported or brought into compliance (e.g., labeling). The costs of the destruction are either paid directly by the owner or cosignee or reimbursed to the government. The failure to make any such reimbursement shall constitute a lien against future imports. Live animals APHIS may order the destruction or removal from the United States of any animal to prevent entry or spread of any pest or livestock disease. The Secretary of Agriculture may also order owners to disinfect the means of conveyance, an individual, or article involved in the importation of animals ordered to be destroyed or removed. If owner fails to comply with destruction/removal orders, the Secretary may recover from the owner the costs of any care/destruction.

Table 1. (Continued) Agency

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Require foreign manufacturers to consent to local court jurisdiction

CPSC No statutory provision mandates that CPSC require foreign manufacturers to consent to local court jurisdiction.

FDA No statutory provision mandates that FDA require foreign manufacturers to consent to local court jurisdiction.

NHTSA No statutory provision mandates that NHTSA require foreign manufacturers to consent to local court jurisdiction.

USDAa No statutory provision mandates that USDA require foreign manufacturers to consent to local court jurisdiction.

Source: GAO analysis of agency guidance. a USDA‘s FSIS oversees meat, poultry products, eggs, and egg products, and APHIS oversees live plants and animals. b FDA oversees other products, including biologics, cosmetics, and radiation-emitting electronic products, but our scope was limited to food, drugs, and certain medical devices. c As stated in this report, CPSC administers other product safety statutes, but these are the three primarily affecting CPSC‘s ability to prevent the entry of unsafe products. d The term ―new drug‖ does not mean simply a drug that is new on the market; rather, it is any drug, regardless of how old, about which insufficient data exists upon which qualified experts can reach a consensus that the drug is safe and effective. See 21 U.S.C. § 321(p). ―In other words, a drug is not a new drug only if it ‗(1) is generally recognized, among experts qualified to evaluate the safety and effectiveness of drugs, as safe and effective for its labeled purposes; and (2) has been used to a material extent for a material time.‘‖ U.S. v. Undetermined Quantities of Cal-Ban 3000, 776 F. Supp. 249, 256 (E.D. N.C. 1991 )(citation omitted)(emphasis added). e For example, with respect to egg products, the foreign inspection official must certify that the products were produced under the approved regulations, requirements, and continuous government inspection of the exporting country. Eggs must be accompanied by a foreign inspection certificate that certifies that the eggs have at all times after packing been refrigerated at the required temperature. With respect to poultry, the foreign inspection official must certify that the product received antemortem and postmortem inspections at the time of slaughter and that such poultry products are sound, healthful, wholesome, and otherwise fit for human food.

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APPENDIX IV. KEY AUTHORITIES OF SELECTED INTERNATIONAL ENTITIES

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We compared consumer product safety authorities, practices, and procedures for Australia, Canada, China, the European Union (EU), Japan and the United States. Figure 3 identifies the authorities and activities we compared, as well as any future plans for changing the organizations, structures, and/or mechanisms for consumer product safety in the respective countries. Following the figure is a more detailed discussion of the authorities, practices, and procedures. The information in this appendix is based on information we received through U.S. Embassies in these countries, foreign embassies in Washington, D.C., and interviews with country officials. We reviewed documents regarding product safety provided by U.S. Embassy officials in the selected countries. We did not independently analyze the laws or procedures of these countries; instead, we relied on third-party assessments of each country‘s consumer product safety framework.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 49

Sources: Official documents from foreign governments and from their official Web sites, from U.S. embassies overseas, andforeign embassies in Washington, D.C. Figure 3. Comparison of Selected International Entities‘ Authorities with CPSC‘s Authorities to Prevent the Entry of Unsafe Consumer Products.

Australia Environment for Consumer Product Safety in Australia Currently, the dominant issue concerning consumer product safety in Australia is the reorganization of its policy framework. On October 2, 2008, the Council of Australian Governments agreed to a new policy framework for implementation in 2010, comprising a single national consumer law and streamlined enforcement arrangements. This more centralized approach to consumer product safety replaces the current system in which the federal, state, and territory governments all share responsibility for consumer policy and enforcement. Key organizations: Currently, responsibility for product safety regulation in Australia is shared between the federal, state, and territory governments. The Australian

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Government Accountability Office Treasury is the agency responsible for developing consumer policy, and the Australian Competition and Consumer Commission monitors and enforces compliance with product safety laws. In addition, state and territory governments each have their own fair trading agencies that enact and enforce state-based consumer product safety legislation. Such legislation is similar, but not identical, to federal government legislation, which sometimes leads to legislative inconsistencies between jurisdictions. Resources: Australia has 30 policy staff working in the Product Safety section of the Australian Competition and Consumer Commission and enforcement staff numbering around 150 around Australia. There is no separate international office for consumer product safety. The total combined resources allocated by the Australian Commonwealth (federal), state and territory governments to enforcement in this area of consumer product safety are estimated to be about A$5 million annually. Consumer advocacy: Consumer advocacy groups have emerged in Australia over the last 40 years in response to growing interest in product safety issues. Groups such as the Australian Consumers Association supply information on safety issues to consumers and lobby federal, state and territory governments to address the most serious product-related hazards.

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Regulatory Framework/System Laws and regulations: Currently, Australia‘s general consumer product safety system is based on the product safety provisions contained in the Trade Practices Act 1974 and on equivalent provisions in Fair Trade Acts in Australia‘s eight states and territories. The administration and enforcement of these provisions, along with other nonregulatory activities conducted by the federal, state, and territory governments, are also part of the system. The Trade Practices Act 1974 contains general product safety provisions, as well as a product liability regime that enables consumers to seek a range of remedies, including damages for loss or damage caused by a defective product. The act provides the Australian government minister responsible for consumer affairs the power to intervene in markets to ensure product safety, including such activities as prescribing consumer product safety and consumer product information standards; declaring products unsafe and banning them; investigating products to determine whether they will or may cause injury and/or issuing a warning notice of the risk of using the product; ordering the compulsory recall of products; and obtaining information, documents, and other evidence related to the administration of the safety provisions of the Trade Practices Act.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 51 While in law the general regime applies to all consumer products, in effect this system provides the general legal safety net for products not otherwise protected by specific legislation that addresses more hazardous products. Definition of safe products: Australia currently has no definition of safe or unsafe products. However, current law allows the Minister for Consumer Affairs to ban or compulsorily recall consumer products in cases where the products will or may cause injury.

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Standards: The Trade Practices Act provides the Australian government minister responsible for consumer affairs with the power to establish mandatory standards for a product where it can be demonstrated that it has the potential to cause injury. Standards Australia, an independent, nongovernmental organization, is the sole recognized body for standards development. Only a small number of imported consumer products are subject to mandatory standards, and over half of the standards apply to products that may pose a danger to children. State and territory legislation also allows for the issuance of mandatory standards. At times, the Australia Competition and Consumer Commission, the Treasury, and the state and territory fair trading representatives have participated in Standards Australia processes. Detection, reporting, and removal of unsafe products: The current regulatory system relies on governments (federal, state, and territory) to identify and regulate specific product hazards. According to Australia‘s Ministerial Council on Consumer Affairs, the ability of these governments to address potential safety hazards across a great range of products is affected by limitations on their resources and by the time and effort required to implement, enforce, and review product-specific regulations. Currently, the vast majority of product recalls are undertaken voluntarily by businesses that have become aware of a safety problem concerning one of their products. The Trade Practices Act and many of the state and territory Fair Trading Acts contain provisions that allow governments to order compulsory product recalls when necessary. Business responsibility: Businesses promote product safety through industry sector associations, which often undertake such self-regulatory activities as business education, the development of industry codes of conduct, and engagement with law enforcement and standards development bodies on enforcement and policy issues. Currently there is no formal requirement for suppliers to monitor the safety of the products they sell, once those products are released to the marketplace. Under the current regulatory system, businesses are required to report voluntary recalls to the Australian government minister responsible for consumer affairs and to the Office of Fair Trading in some other jurisdictions. The Ministerial Council on Consumer Affairs has proposed that suppliers be required to monitor the ongoing safety of the products they sell and report to the government any products that are under investigation for possible safety risks, have been associated with serious injury and death, or have been the subject of a successful product liability claim.

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Government Accountability Office Policy enforcement and compliance: The Australian Competition and Consumer Commission is responsible for enforcing the Trade Practices Act‘s product safety regime. To ensure that suppliers subject to mandatory standards and bans are responding appropriately, the commission may compel the provision of information, require evidence under oath, undertake random market surveys, enter premises, and seize documents. In situations where suppliers have failed to comply with mandatory standards or bans, the commission can seek orders in the Federal Court requiring such suppliers to recall the noncomplying products. Additionally, the commission may institute civil proceedings or criminal proceedings under the Trade Practices Act. State and territory governments have enforcement powers similar to those of the Competition and Consumer Commission under their own legislation. The relevant state and territory Fair Trading Acts contain criminal liability provisions similar to those in the Trade Practices Act.

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Future Plans On October 2, 2008, the Council of Australian Governments agreed to a new consumer policy framework as proposed by the Ministerial Council on Consumer Affairs. According to the Australian government, the new framework consists of a single national consumer law and streamlined enforcement arrangements. Australia‘s states and territories are expected to adopt the new Trade Practices Act in its entirety in 2010, providing a harmonized product safety regime with greater federal government control. The council recognized that while Australia‘s current consumer policy framework has strengths, it is in need of significant improvements to overcome existing inconsistencies, gaps, and duplication in Australia‘s consumer legislation and its enforcement. The reforms have the following three key elements: the development of a consumer law (called the Australian Consumer Law) to be applied both nationally and in each state and territory, which is based on the existing consumer protection provisions of the Trade Practices Act 1974, and which includes a new national provision regulating unfair contract terms, new enforcement powers and, where agreed, changes based on best practices in state and territory laws; the implementation of a new national product safety regulatory and enforcement framework, as part of the national consumer law; and the development of enhanced enforcement cooperation and information-sharing mechanisms between national and state and regulatory agencies.

Canada Environment for Consumer Product Safety in Canada Changing consumer demands, new technologies, and the increasing complexity of global supply chains are the major influences behind Canada‘s current efforts to modernize its regulatory tools for consumer product safety. According to the Canadian government, the authorities governing food, health, and consumer products in Canada derive from legislation developed in the 1950s and 1960s and, as a result, they are out of step with modern realities and needs. For example, the Canadian government lacks sufficient authority to issue a

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 53 mandatory recall of a health or consumer product if it poses a serious or imminent risk to health and safety or to compel manufacturers to take steps to reduce the risk associated with a product. In addition, according to the Canadian government, fines and penalties are low compared with those of other countries. New legislation will update and strengthen Canada‘s consumer product safety framework. Key organizations: Currently, Health Canada regulates the import, sale, and advertisement of hazardous products or substances. Health Canada

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supports the development of safety standards and guidelines; enforces legislation by conducting investigations, inspections, seizures, and prosecutions; tests and conducts research on consumer products; provides importers, manufacturers, and distributors with hazard and technical information; publishes product advisories, warnings, and recalls; and promotes safety and the responsible use of products. The Canada Border Services Agency is responsible for stopping goods at the border. The agency has a service agreement with Health Canada under which it seeks to prevent prohibited products from entering Canada and facilitates additional targeted inspections of these products, as well as shipments of products from companies with histories of poor compliance. In addition, the agency‘s Single Window Initiative will give the department access to import and export data that will help to efficiently approve shipments of low-risk products from low-risk suppliers or, alternatively, tag suspicious ones before they have left their point of export. Other organizations include the Standards Council of Canada, the Canadian Standards Association, the Canadian General Standards Board, and the Underwriters‘ Laboratories of Canada. Also, Canada‘s Provincial governments have jurisdiction over the adoption of the National Building Code, which includes certification requirements for electrical, gas, and plumbing products. Resources: Canada‘s consumer product safety agency, within Health Canada, consists of 130 employees who serve as laboratory, compliance, and policy development staff. Consumer advocacy: Consumer advocacy groups in Canada are particularly concerned with consumer safety issues related to children‘s products and food products. Some advocacy groups in Canada include the Canada Toy Testing Council, the Consumers‘ Association of Canada, Consumers Council of Canada, and the Public Interest Advocacy Centre.

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Regulatory Framework/System Laws and regulations: The Canadian government‘s key legislation governing consumer product safety is the Hazardous Products Act. Part 1 of the act lists consumer products that are either restricted through regulation or outright prohibited from being advertised, sold, or imported into Canada. There are approximately 30 products and product categories that are regulated, and some 25 others that are prohibited. All imported products are subject to the D Memoranda, which incorporates legislation, regulations, policies, and procedures used by the Canada Border Services Agency. Canada‘s Chemical Management Plan also has an impact on consumer product safety. Definition of safe product: Canada has no specific definition under the Hazardous Products Act. However, a new act, currently awaiting Canadian Senate approval as of June 2009, will include a definition of ―danger to human health or safety,‖ which will support a general prohibition.

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Standards: Some consumer product standards are mandatory legal requirements, others are industry standards developed on a voluntary basis, and some are purely market driven as a particular technology becomes the industry standard. Approximately two-thirds of standards in Canada are voluntary. Federal and provincial legislation may impose mandatory standards for products, typically where health or safety issues are regarded as requiring regulation. Standards can also be written into the legislation itself; such is the case with certain specifications in toy regulations under the Hazardous Products Act. The Standards Council of Canada is the national coordinating body for the development of voluntary standards through the National Standards System. Detection, reporting, and removal of unsafe products: The current Canadian product safety regulatory system follows a reactive approach. When a product has been deemed to pose a risk to users—usually over a period of time, with reported injuries and/or deaths associated with the product‘s use—a risk assessment is carried out. The regulatory process involves many steps, including consultation with public, industry, and technical experts. The end result is either that the product remains available for sale in the Canadian marketplace or that Health Canada imposes a legal ban on the product under the Hazardous Product Act. Business responsibility: Currently, there is no mandatory reporting for businesses, and Health Canada relies largely on negotiating with suppliers to voluntarily recall or take other corrective measures to address a product that poses an unreasonable danger to the health or safety of consumers. The new Consumer Product Safety Act (discussed below) will give inspectors the ability to order a suppler to take corrective measures.

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 55 Policy enforcement and compliance: Canadian authorities have the ability to seize products, prosecute violations through a criminal code, and impose civil money penalties. The maximum amount of a civil money penalty is $1 million per violation, although penalties of $25,000 are most common.

Future Plans On June 12, 2009, Canada‘s new Consumer Product Safety Act was passed by the House of Commons and, as of the end of June 2009, is awaiting final action by the Canadian Senate. The Consumer Product Safety Act would replace Part I of the Hazardous Products Act and includes a new regulatory regime. The act focuses on three key areas: Working to address problems before they happen: The legislation introduces a general prohibition against the manufacture, importation, advertisement or sale of consumer products that pose an unreasonable danger to human health or safety. It strengthens compliance promotion and enforcement activities through increased fines up to $5 million for some offenses and fines that are left to the discretion of the courts where the offense is committed knowingly or recklessly.

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Targeting the highest risk: The act provides the authority to require suppliers to conduct safety tests upon a minister‘s orders and to provide the results where there are indications of a problem. The legislation will also require suppliers to notify Health Canada of serious incidents or defects and to provide detailed reports about the incidents. Rapid response: The act allows the Canadian government to take more immediate responsive action to protect the public when a problem occurs. It would authorize inspectors to order mandatory recalls and other corrective measures to address unsafe consumer products and would require suppliers to maintain accurate records to enable quick product tracking. In addition, to further improve the government‘s ability to respond effectively, Health Canada would double the number of product safety inspectors.

European Union Environment for Consumer Product Safety in the EU In 2007, in response to massive recalls of consumer products worldwide, the European Commission (EC) conducted an internal review of the European Union (EU) product safety framework.87 The review concluded that the community regulatory system (discussed below), including the General Product Safety Directive, was capable of providing to European citizens a high level of protection against unsafe consumer products, as long as the rules of the system were properly applied. The review identified areas for improvement and ways of perfecting their system. The review stated that the adoption of the ―Commission Decision‖ on magnets in toys88; the revision of the ―European Directive‖ on the safety of toys;89 and the issuance of rules called the ―New Legislative Framework‖ for the marketing of goods; would

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also raise the existing level of protection.90 It also identified some areas for further attention.91 These findings were subsequently referred to in an official EU report on the implementation of the relevant legislation.92

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Key organizations: The EC Directorates General for Health and Consumers (consumer product safety), Enterprise and Industry (safety of regulated products) and Taxation and Customs Union (import safety) put forth legislation aimed at further ensuring the safety of products. The Directorate General for Health and Consumers, referred to as DG SANCO, is an EU branch that is somewhat equivalent to CPSC in driving consumer product safety matters both within Europe and internationally. However, EU member states (currently 27 individual countries) are responsible for implementation and enforcement of EU legislation. Each member state has established its unique structures for handling product safety given their cultural history and industrial background. The European Commission coordinates their approaches and ensures their cooperation. Resources: Because of the very different role of the EC as compared to CPSC in product safety enforcement, EU officials had difficulties providing us with useful figures on resources and stated they risked being seriously misleading if the member states‘ role was not taken into consideration. They did not have conclusive data for the member states. Different commission departments also perform part of their functions related to consumer product safety, such as reviewing European legislation in certain sectors relevant for consumer safety, which would make sense to include in their ―central function‖ resources. While the ―Product and Service Safety‖ unit in DG SANCO is generally comparable to CPSC in terms of policy function, it does not include actual implementation and enforcement at the level of the individual member states. Many staff from the Product and Service Safety unit play a role in the ―international‖ (versus ―European‖) area, but also have other responsibilities. DG SANCO determines who represents the EU at the international level by the subjectmatter expertise for product safety.

Regulatory Framework in the EU Laws and regulations: The General Product Safety Directive sets out the basic consumer product safety requirements and defines a ―consumer product,‖ and Article 2(b) and (c) of the directive defines ―safe‖ and ―unsafe‖ product. A ―dangerous product‖ is any product that does not meet the definition of a ―safe‖ product. Definition of safe product: The directive defines a ―safe product‖ as any product which—under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements—does not present any risk or only the minimum risks compatible with the product‘s use. Such a product is considered to be acceptable and consistent with a high level of protection for the safety and health of persons taking into account the following points in particular:

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 57 the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, instructions for installation and maintenance; the effect on other products, where it is reasonably foreseeable that it will be used with other products; the presentation of the product, the labeling, any warnings and instructions for its use and disposal, and any other indication or information regarding the product; and the categories of consumers at risk when using the product, in particular children and the elderly.

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In addition, the feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ―dangerous.‖ In response to inconsistencies and identified weaknesses in the EU legislative framework for product safety, the EU issued additional regulations on marketing of products within the member states. Adopted in July 2008, this new framework aims to strengthen accreditation and market surveillance across member states and to remedy existing weaknesses of the legislative framework. It will apply from 2010. Guidance will be issued on its relation with the General Product Safety Directive. Standards: The EU product safety system is based on voluntary standards. However, products that are manufactured to harmonized standards developed by recognized European standardization bodies (CEN, CENELEC, and ETSI) on the basis of a mandate (formal request) by the EC and ultimately referenced on the ―Official Journal‖ of the EU benefit from a presumption of conformity with the safety requirements of the relevant legislative framework that are covered by those standards.93 The EU considers their safety requirements to be the backbone of its system. The safety requirements are expressed in sectoral (industry or productspecific) directives, conformity assessment measures and, in certain sectors, the availability of European standards. The General Product Safety Directive fills in the gaps when no sectoral Directive exists. For example, the EU has specific sectoral directives on toys, and some industrial products, such as electrical products, machinery, and pressure equipment. Businesses must carry out conformity and safety assessments of their products in accordance with the General Product Safety Directive and/or specific legislation applicable to their products. Businesses are required to certify that their products are safe, as defined under the directive. For some products self-declaration is sufficient, but other products require third-party verification. Detection, reporting and the removal of unsafe products: The EU and its member states have the authorities to require mandatory recalls, and companies can negotiate voluntary recalls as necessary, similar to U.S. recalls. Under the General Product Safety Directive and applicable product-specific legislation, national authorities can ban the marketing of a dangerous product, order or organize its actual and immediate withdrawal, alert consumers to the risks it presents, order or coordinate its recall

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Government Accountability Office from consumers, and order or organize its destruction in suitable conditions. Businesses are required to report to the authorities if they detect that they have a dangerous product. Businesses also must remove unsafe products from markets and are under legal obligation to stop, withdraw, and/or recall their distribution. Businesses are required to repair or replace products and/or refund consumers the cost under certain criteria.

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Policy enforcement and compliance: DG SANCO has no inspection and no jurisdictional authority. Member-state authorities can review technical product files that all businesses are required to maintain to certify general conformity with product standards. Within the common market, the regulations apply to the importer, distributor, manufacturer, and retailer. Imported products must meet the same requirements as domestic products. Member states must have authorities to carry out appropriate sampling and safety testing of domestically manufactured or imported products and to follow-up on consumer complaints. According to the EC report on its consumer product safety framework, the EU considers its customs controls to be reactive—no proactive obligation exists for the customs authorities to carry out controls for unsafe products at the EU borders on their own initiative. In response, the EU issued a ―Council Regulation‖ to provide customs authorities with the legal basis and equally applicable and comparable procedures in all member states to suspend, for no more than 72 hours, the release of products which they suspect pose a serious risk to health and safety. Consumer advocacy: A unique feature of the EU approach to consumer product safety is the funding support they provide to consumer representation groups through grants. As part of this approach, the consumer groups help define priority/future issues that require additional research and contribute to standard-making, and consumer groups can apply for grants to survey and educate consumers on these emerging issues.

Japan Environment for Consumer Product Safety in Japan Japan‘s Consumer Product Safety Law regulates the manufacture and sale of specific products to prevent harm and injury to consumers, to secure the safety of consumer products, and to promote voluntary activities of private business for the benefit of general consumers. Japan‘s consumer product safety policies and procedures have been developed, implemented, and enforced by a wide variety of government agencies and organizations. As with some of the other countries we reviewed, Japan recently reorganized its approach and mechanisms for consumer product safety and food safety with the creation of the new Consumer Affairs Agency, as follows: Key organizations: The Ministry of Economy, Trade, and Industry (METI) is the key government organization responsible for developing consumer product safety policy

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 59 in Japan. The National Institute of Technology and Evaluation conducts on-the-spot inspections of enterprises in accordance with METI‘s instructions and analyzes the cause of accidents based on accident information to prevent future problems. The Consumer Policy Council, the Quality-of-Life Policy Council, and the National Consumer Affairs Center of Japan also have roles in advising and supporting the government on consumer-related issues in Japan. The Japan Cabinet Office carries out general coordination of basic consumer policies among related ministries and agencies. Resources: According to Japanese officials, 33 staff members are devoted to consumer product safety, as part of the Product Safety Division of METI. However, other staff located in other agencies, as indicated above, also work on these issues. Consumer advocacy: According to U.S. Embassy officials in Tokyo, consumer product safety issues receive considerable attention in the local press and the Japanese government, and consumers view consumer product safety as a major priority. A survey conducted by the cabinet office in 2005 found over 2,800 consumer groups active in Japan. Seven nonprofit consumer groups have been officially accredited by the Japanese government. They are

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Consumer Organization of Japan, Kansai Consumers Support Organization, Japan Association of Consumer Affairs Specialists, Kyoto Consumer Contract Network, Consumer.net Hiroshima, Hyogo Consumers Net, and Saitama Organization to Abolish Damage to Consumers.

Regulatory Framework/System Laws and regulations: Domestic and imported consumer products are regulated by the following laws in Japan: the Consumer Product Safety Law, the Household Goods Quality Labeling Law, the Law for the Control of Household Goods Containing Harmful Substances, the Chemical Substances Control Law, and the Electrical Appliance and Material Safety Law. Other laws relating to consumer protection include the Product Liability Act, the Consumer Contract Act, the Consumer Basic Act, and the Whistleblower Protection Act.

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Under Japan‘s Consumer Product Safety Law, METI collects and makes public information on serious accidents involving consumer (household) products. The law requires manufacturers, marketers, and/or importers to report actual serious accidents to METI, which in turn informs the public. Manufacturers, marketers, and/or importers are also required to inform the public of the product safety issues involved. Major national consumer centers compile complaints from consumers, including product safety complaints. Depending on the product type, relevant ministries maintain regulations covering consumer products, including ensuring that products meet appropriate standards and labeling and certification requirements. Some ministries may require foreign manufacturers to register foreign manufacturing sites with the local government. Definition of safe product: Article 1 of the Consumer Product Safety Law defines products as unsafe if they cause threat to consumers‘ life or health. In addition, Article 2, Section 2, of the Product Liability Act provides that a defective product is to be considered as unsafe, taking into account the nature of the product, the ordinarily foreseeable use of the product, the time when the manufacturer delivered the product, and other circumstances.

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Standards: Product requirements in Japan fall into two categories: technical regulations (or mandatory standards) and nonmandatory voluntary standards. Compliance with regulations and standards is also governed by a certification system in which inspection results determine whether or not approval (certification/quality mark) is granted. To affix a mandatory quality mark or a voluntary quality mark requires prior product type approval and possibly factory inspections for quality control assessment. Certain regulated products must bear the appropriate mandatory mark when shipped to Japan in order to clear Japanese Customs. Safety standards are specific to types of products and fall under the jurisdiction of the relevant ministry. Policy enforcement and compliance: Generally, the importer of record is responsible for ensuring the quality and safety of imported consumer products in Japan. If a product is deemed harmful or defective, the importer is responsible for working with local authorities and consumer outlets to take necessary measures. The government may take action against the importer, such as conducting on-site inspection of business offices, plants, stores, and/or warehouses; ordering mandatory product recalls; suspending business operations for a certain period of time; or imposing penalties including fines and/or imprisonment.

Future Plans On May 29, 2009, the Japanese Diet approved bills establishing the Consumer Affairs Agency, which will administer consumer protection issues in Japan. The agency will begin operating in the fall with about 200 staff from the Cabinet Office; the Fair Trade Commission; the Ministry of Economy, Trade and Industry; the Ministry of Agriculture, Forestry and Fisheries; and the Ministry of Health, Labor and Welfare. In addition, 60 temporary staff will be appointed from attorneys, consumer affairs consultants, and academics. The Consumer Affairs Agency will be placed under the Cabinet Office, and

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Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 61 Consumer Affairs Centers nationwide will be established to provide information about product-related accidents and complaints. In addition, the Consumer Affairs Committee will be established at the same time to monitor the Consumer Affairs Agency. The committee—an independent body— will have authority to request information and reports from ministries and make recommendations for crisis management, through the Prime Minister, in the event of consumer incidents.

China

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Environment for Consumer Product Safety in China China imports relatively few manufactured products compared with its exports. Consumer products that are imported tend to come from more developed and more regulated markets in Europe, Japan, and the United States. Therefore, China faces proportionally fewer challenges with regard to import products. Further, the costs of testing products and certifying them for sale, as well as the costs of shipping and tariffs, make it difficult for imported products to compete with Chinese domestic products in similar product categories. Recent high-profile cases in China involving food and product safety have affected China‘s export reputation. These cases appear to have prompted the government to raise the priority of food and product safety. Laws and regulations: China‘s fundamental law on product safety is The Law of the People‘s Republic of China on Product Quality, which was written in 1993 and revised in 2000. This law preceded the establishment of China‘s leading quality and safety agency, the General Administration for Quality Supervision, Inspection, and Quarantine (AQSIQ). The law sets a very low standard for corporate liability by defining the amount of damages and fines that can be collected through lawsuits. It also applies some penalties to entities that can claim ignorance of the law. The law makes no reference to foreign manufactures or domestic goods. China‘s main regulatory code pertaining to imported consumer goods is found in AQSIQ‘s Regulations for Compulsory Product Certification. Issued in 2001, this regulation created a uniform standard for imported and domestically manufactured goods, as well as a certification mark known as China Compulsory Certification (CCC) or 3C. The regulation applies to a catalogue of products that must be approved by AQSIQ prior to general sale in China. The standards for individual products are defined separately by national and industry standards. CCC testing is conducted mostly by enterprises owned in whole or in part by AQSIQ; foreign testing companies have not been approved to conduct CCC tests, but neither have they been explicitly excluded. The Law of the People‘s Republic of China on Import and Export Commodity Inspection is the main law pertaining to import and export inspections. The law dates to 1989 and provides for fee-based inspections at port, as well as preshipment inspections that may be conducted in a foreign country. The law empowers the provincial-level organizations of AQSIQ—known as Customs, Inspection and Quarantine (CIQ)—to conduct inspections. The law also provides for an appeal

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Government Accountability Office process in case the importer or exporter disagrees with the result of an inspection. The law sets penalties for evading the inspection process, trading in counterfeit goods, and corrupt practices. However, recent problems with food and product safety demonstrate that the local inspection offices responsible for both food and product testing may lack robust technical abilities and the capacity to deal with the current volume of trade.

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Key organizations: AQSIQ is China‘s leading quality and safety agency. Standards are issued by the Standards Administration of China, a division of AQSIQ, which also represents China in international standards organizations. The Certification and Accreditation Administration of the People‘s Republic of China (CNCA), which is also technically part of AQSIQ, is responsible for certifying and accrediting functions related to CCC tests. Numerous testing companies, almost all partially owned by AQSIQ, carry out testing for the CCC system. A catalogue of China‘s specific products required to obtain CCC approval can be found on CNCA‘s Web site.94 In 2009, CNCA revoked a provision to allow the limited importation of any product not certified with a CCC mark. Unlike similar approvals for the United States, foreign manufacturers applying for CCC approval must pay all costs, including travel and lodging expenses of Chinese inspectors traveling to the foreign country for factory inspections. Routine inspections, factory checks, recalls, and other regulatory actions are carried out mostly by AQSIQ‘s provincial representative offices, CIQ. China also has a product recall entity know as the Defective Product Administrative Center, a part of AQSIQ, which is responsible for the oversight of product recalls. The center is technically responsible for consumer products, but its primary focus is on automobile safety. The local CIQ offices are responsible for overseeing recalls at the local level. The national system for product recalls is still undeveloped. Standards: China has a comprehensive body of regulatory standards that fall into four categories: National Standards, Industry Standards, Local Standards, and Enterprise Standards. Each category includes aspects of product safety. The governing law for these categories dates to 1988 and applies to a range of industries and fields, not just consumer products. Some of these regulatory standards are more clearly spelled out in product-specific codes published on the CNCA Web site. Under China‘s system, there are both mandatory and voluntary standards. Mandatory standards are those intended to safeguard human health, personal property, and safety and those enforced by laws and administrative regulations. All others are voluntary standards. Similarly, under the CCC product certification system, some products are not subject to compulsory certification but can be certified on a voluntary basis. The voluntary process is known as the China Quality Certification Center‘s Voluntary Product Certification System. It applies to products that are not included in an itemized catalogue of products subject to mandatory certification. The system is also an AQSIQ function, and this certification is limited to Chinese companies only. Policy enforcement and compliance: CIQ offices are responsible for local enforcement actions. Local CIQ offices have responsibility for inspecting and Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

Better Information and Planning Would Strengthen CPSC‘s Oversight of Imported… 63 certifying factories, issuing and revoking manufacturing licenses, issuing or revoking export permits, conducting preshipment export inspections, and clearing or refusing goods for importation into China. Local CIQ offices have their own laboratory facilities but often call upon AQSIQ headquarters for policy guidance and technical support. Local CIQ offices also have the authority to initiate a mandatory recall, although China‘s recall system is still developing. As of July 2009, China‘s recall provisions emphasized the cessation of manufacturing and sale of dangerous goods and included no methodical system for the physical collection of goods already sold. According to U.S. Embassy officials in Beijing, draft regulations in China on product recalls represent a positive step for improved product safety. Authority to inspect foreign manufacturing plants: China unambiguously holds and maintains the authority to inspect foreign-owned plants operating in China, and such inspections are conducted by AQSIQ and the Ministry of Health. However, for any plant operating only for the purpose of export manufacturing (i.e., no sales in China), AQSIQ takes a less rigorous approach to regulation. Such plants are not required to undergo the same assessments as plants manufacturing for local consumption. U.S. Embassy officials in Beijing stated that they are unaware of any memorandum of understanding that AQSIQ may have to facilitate foreign inspections. However, the CCC system requires factory inspection to be conducted by a certification body that has been accredited by CNCA. Only one non-Chinese certification and testing body, Underwriters Laboratories, has been accredited to conduct follow-up factory inspections in the United States for CCC approval. CNCA has similar arrangements with other countries.

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End Notes 1

Pub. L. No. 110-314, 122 Stat. 3016 (Aug. 14, 2008). See Consumer Product Safety Improvement Act of 2008 § 225, Pub. L. No. 110-3 14, 122 Stat. at 3070. 3 The EU is a customs territory, but we refer to it as a country in this report for ease of reference. 4 Pub. L. No. 92-573, 86 Stat. 1207 (Oct. 27, 1972) (classified, as amended, at 15 U.S.C. §§ 2051 et seq.). 5 See Consumer Product Safety Act § 30, Pub. L. No. 92-573, 86 Stat. 1207, 1231 (classified, as amended, at 15 U.S.C. § 2079). 6 Act of June 30, 1953, ch. 164, 67 Stat. 111 (classified, as amended at 15 U.S.C. §§ 1191 et seq.). 7 Pub. L. No. 86-613, 74 Stat. 372 (July 12, 1960) (classified, as amended, at 15 U.S.C. §§ 1261 et seq.). Under the act, CPSC is authorized to declare a substance to be a hazardous, and to regulate the labeling of substances which are declared to be hazardous. 15 U.S.C. § 1261(f)(1)(B) and § 1262. 8 Pub. L. No. 9 1-601, 84 Stat. 1670 (Dec. 30, 1970) (classified, as amended, at 15 U.S.C. §§ 1471 et seq.). 9 Act of August 2, 1956, c. 890, 70 Stat. 953 (classified, as amended, at 15 U.S.C. §§ 1211 et seq.). Under the act, it is unlawful for any person to introduce or deliver for introduction into interstate commerce any household refrigerator, unless it is equipped with a device enabling the door to be opened from the inside and which conforms with the standards prescribed by CPSC. 15 U.S.C. § 1214. 10 Pub. L. No. 110-140, Title XIV, 121 Stat. 1492, 1794 (Dec. 19, 2007) (classified at 15 U.S.C. §§ 8001 et seq.). 11 Pub. L. No. 110-278, 122 Stat. 2602 (July 17, 2008) (classified as a note to 15 U.S.C. § 2056). 12 CPSC has not been authorized to receive appropriations for more than three commissioners since fiscal year 1993. See Pub. L. No. 102-389, Title III, 106 Stat. 1571, 1596 (Oct. 6, 1992). Section 202(b) of CPSIA repealed this provision, effective August 14, 2009. We have previously found that CPSC could benefit by changing to a single administrator because some of the basic assumptions about the need to have commissioners had not been realized. See GAO, Consumer Product Safety Commission: Administrative Structure Could Benefit from Change, GAO/HRD-87-47 (Washington, D.C.: Apr. 9, 1987). 2

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Products subject to such mandatory standards are often referred to as ―regulated products.‖ Regulated products that do not comply with mandatory standards are often referred to as ―violative products.‖ 14 See 15 U.S.C. § 2057; 15 U.S.C. § 1262; 15 U.S.C. § 1193; and 15 U.S.C. § 1472. Banned products include unstable refuse bins, extremely flammable contact adhesives, lead- containing paint, consumer patching compounds containing asbestos, artificial emberizing materials containing asbestos, and lawn darts. See 16 C.F.R. §§ 1301-1306. 15 Although voluntary standards do not have the force of law, every manufacturer of a consumer product must inform the commission if they obtain information that reasonably supports the conclusion that the product is defective such that it presents a substantial product hazard, as defined below. 15 U.S.C. § 2064(b). Such a report may include information the manufacturer obtained about a product outside the United States if it is relevant to products sold or distributed in the United States. 16 C.F.R. § 1115.12(f). 16 15 U.S.C. § 2056(b)(1). 17 16 C.F.R. § 1009.3(a). When it appears that application of this policy is unduly burdening the free flow of goods, the commission states that it may consider modifications that alleviate such burdens, but not those that do not assure the consumer the same protection from unsafe foreign goods as from unsafe domestic goods. 16 C.F.R. § 1009.3(i). 18 15 U.S.C. § 2066(h). 19 Harmonized Tariff Schedule is an extension of the six-digit Harmonized Commodity and Coding System, the internationally recognized classification system for commodities. The Harmonized Tariff Schedule is a statutory authority codified at 19 U.S.C. § 1202. 20 A manifest is a document or compilation of documents required by law for most conveyances arriving in United States territory. A manifest provides information describing the cargo on board the arriving conveyance. See 19 U.S.C. § 1431; 19 C.F.R. § 4.7; 19 C.F.R. § 122.48; and 19 C.F.R. § 123.4. 21 An imminently hazardous consumer product is a consumer product that presents imminent and unreasonable risk of death, serious illness, or severe personal injury. 15 U.S.C § 2061(a). CPSC states that it has not used its authority to refuse admission of an imminently hazardous consumer product because it requires filing an action in U.S. District Court, which is a resource-intensive process. Instead, CPSC states that it works cooperatively with the manufacturer to remove the product from the market, which can include seizure and detention of products at the port by CBP, if necessary. 22 A product may present a substantial product hazard if it fails to comply with a mandatory standard or is otherwise found to have a defect, and if the product creates a substantial risk of injury to the public. 23 CPSC officials told us that there is statutory authority under the Tariff Act of 1930, revised, that places certain obligations and time constraints on CBP for issuing detention notices and making decisions regarding detained products, but that authority expressly exempts from those requirements detentions made where the decision as to admissibility resides with an agency other than CBP. See 19 U.S.C § 1499. Accordingly, CPSC officials stated, neither CBP nor CPSC is bound by those procedural constraints when merchandise is detained under CPSC authority. 24 15 U.S.C. § 2066(e). CBP has the authority to supervise the exportation of refused consumer merchandise. See 19 C.F.R. § 158.45. 25 Effective August 14, 2009, the civil penalty maximum amounts are $100,000 for each individual violation and $15 million for a related series of violations. 15 U.S.C. § 2069(a)(1). The criminal penalties for a knowing and willful violation of the Acts that CPSC enforces could result in up to 5 years in prison and fines of up to $250,000 for individuals and $500,000 for corporations for each offense. 15 U.S.C. § 2070(a). 26 For example, according to CBP‘s 2009-2013 Trade Strategy, on a typical day CBP processes over 85,000 shipments of goods worth $5.2 billion. However, CBP indicated that after steady growth in imports the past few years, the overall value of imports entering the United States has decreased to $900 billion as of mid-fiscal year 2009, a decrease of $200 billion from fiscal year 2008. CBP also projects that the value of imports for fiscal year 2009 will decline to as low as $1.7 trillion, which was the level in 2004-2005. 27 15 U.S.C. § 2063(a)(1). Section 14 of the Consumer Product Safety Act (classified, as amended, at 15 U.S.C. § 2063) has always required that manufacturers and private labelers of consumer products subject to a product safety standard issue a certificate that certifies that such product complies with the applicable mandatory standard. The certificate must be based on a test of each product or upon a reasonable testing program. However, CPSC told us that they did not enforce the certification requirement at the ports of entry, but rather focused on the compliance of the product with the underlying mandatory standard. Furthermore, the previous certification requirement in the Consumer Product Safety Act applied only to products subject to mandatory standards promulgated under the act rather than each of the laws administered by the CPSC. 28 15 U.S.C. § 2063(a)(2). A children‘s product is defined as a product primarily intended for children age 12 and under. 15 U.S.C. § 2052(a)(2). CPSC is in the process of defining rules by which accredited third party laboratories are eligible to conduct testing for conformance with certain mandatory standards; that is, the laboratories do not receive a blanket accreditation from CPSC. CPSC is required to establish requirements for periodic audits of accredited third party laboratories and may withdraw accreditation under certain circumstances. 15 U.S.C. § 2063(d)(1) and (e).

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CPSC provided three reasons why surveillance is focused on these products. First, the HTS may not be specific enough to accurately identify specific products subject to CPSC mandatory standards. Generally speaking, the HTS is used to describe all goods in trade. Importers use a code from the HTS to identify goods in shipments. If the code is not specific enough, then CPSC states that it has difficulty targeting specific products. Second, CPSC states that the mandatory standards for these consumer products are written in a manner that allows for easy identification of violative products at the port. Third, CPSC states that fireworks and lighters, as well as toys, are among the most common consumer products imported into the United States, so it conducts increased port surveillance to prevent unsafe products from entering the market. 30 CPSC may by rule determine that certain characteristics of a product or class of products, by their absence or presence, shall be deemed a substantial product hazard if (1) the characteristics are readily observable and addressed by voluntary standards, (2) the voluntary standards have been effective in reducing the risk of injury, and (3) there is substantial compliance with such standards. 15 U.S.C. § 2064(j). Characteristics of products often used as examples for the substantial product hazard list include the presence of drawstrings in hooded sweatshirts intended for children and the absence of a ground fault circuit interrupter in electric hairdryers. 31 Pursuant to 15 U.S.C. § 2066(b), an importer may demand a full administrative hearing to contest a refusal of admission made on the basis of a CPSC staff-level substantial hazard determination. CPSC states that this is a resource-intensive process. See 16 C.F.R. § 1025. With the substantial product hazard list, CPSC states that if its determination to refuse admission is challenged by the importer, the only issue at the administrative hearing would be whether the product is on the substantial product hazard list. 32 Products subject to no standards cannot, by law, be included on the list. CPSC staff told us that it is very difficult to judge whether a product is defective when there is no standard with which to compare the product. CPSC staff stated that this is particularly true at ports of entry where there is pressure to move products quickly into commerce. Moreover, manufacturing or design defects in products are not always readily apparent and can take some time to surface, sometimes only after consumers have used the product. 33 See ―Notice of Stay of Enforcement of Testing and Certification,‖ 74 Fed. Reg. 6396 (Feb. 9, 2009). 34 See Natural Resources Defense Council, Inc., and Public Citizen, Inc., vs. U.S. Consumer Product Safety Commission, 597 F.Supp 2d. 370 (S.D.N.Y. 2009). 35 For example, the Retail Industry Leaders Association, a U.S. trade group, has recently partnered with the United Kingdom‘s retailers association, the British Retail Consortium, to develop global manufacturing standards and risk management practices. In addition, two trade groups that specialize in children‘s products—the Toy Industry Association and the Juvenile Products Manufacturers Association—have developed their own certification programs. The American Fireworks Standards Laboratory has, for several years, had a testing and certification program for the fireworks industry in response to the failure of over half of all imported fireworks to meet federal safety standards and to CPSC‘s seizure of these products in the 1980s. 36 Through this program, CPSC has worked with CBP and U.S. Immigration and Customs Enforcement, a component of the U.S. Department of Homeland Security that enforces U.S. customs and immigration laws, to implement national programs targeting (1) lighters that do not comply with CPSC‘s mandatory regulations, (2) holiday lights that pose a fire or electrocution hazard, and (3) toys that do not comply with CPSC requirements. According to CPSC, the agency‘s involvement in Operation Guardian dates back to December 2007. 37 So far, two consumer product companies have joined the program—J.C. Penney and Hasbro—and, according to CBP and a trade group, both have had positive experiences thus far. 38 See Consumer Product Safety Improvement Act of 2008 § 222(a), Pub. L. No. 110-314, 122 Stat. at 3066. 39 Upon completion of its risk assessment methodology, CPSIA requires CPSC to submit a report to Congress within 180 days regarding changes made or necessary to be made to its MOU with CBP. See Consumer Product Safety Improvement Act of 2008 § 222(d)(2), Pub. L. No. 110-3 14, 122 Stat. at 3068. 40 The time frames for receiving manifest data for goods entering the United States through other modes of transportation—air, train, or truck—vary. 41 Section 405 of the SAFE Port Act requires all federal agencies with import regulatory responsibility, including CPSC, to participate in the International Trade Data System. Pub. L. No. 109-347, 120 Stat 1884, 1929 (Oct. 13, 2006) (classified at 19 U.S.C. § 1411). 42 According to CBP, the 2002 MOU will likely need to be updated to reflect changes to the relationship between CPSC and CBP that have resulted from enactment of CPSIA, and updating the 2002 MOU may also help CPSC prepare the risk assessment methodology described above. 43 See Consumer Product Safety Improvement Act of 2008 § 222(b) and (c), Pub. L. No. 110- 314, 122 Stat. at 3067. 44 The National Targeting Center is a centralized coordination point for all of CBP‘s antiterrorism knowledge. 45 The Automated Targeting System is a system CBP uses to target shipments for further screening and review at U.S. ports of entry. The system contains manifest data on shipments of consumer products. 46 See Consumer Product Safety Improvement Act of 2008 § 202(c)(1) and (2), Pub. L. No. 110-314, 122 Stat. at 3040.

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Pub. L. No. 110-314, § 224(a), 122 Stat. at 3069-70 (to be classified at 15 U.S.C. § 2088). See GAO, Feasibility of Requiring Financial Assurances for the Recall and Destruction of Consumer Products, GAO-09-512R (Washington D.C.: Apr. 22, 2009). 49 See 15 U.S.C. §§ 2065(d) and 2066(g). CPSC has authority to enter and inspect, at reasonable times and in a reasonable manner, a ―factory, fire-walled conformity assessment body, warehouse, or establishment where such products are manufactured, held, or transported and which may relate to the safety of such products.‖ 15 U.S.C. § 2065(a). Also, every manufacturer, private labeler, or distributor of a consumer product is required to establish and maintain records reasonably required by the commission to implement the Consumer Product Safety Act. 15 U.S.C. § 2065(b). 50 CPSC believes that certifications and tracking labels on consumer products may help in this regard. When implemented, certifications must identify the manufacturer issuing the certificate and the place of manufacture. See 15 U.S.C. § 2063(g)(1). Also, the Consumer Product Safety Act requires, as of August 14, 2009, that tracking labels be placed on children‘s products identifying the specific source of the product. See 15 U.S.C. § 2063(a)(5). 51 See, for example, 15 U.S.C. § 2056-2057 (CPSC); 21 U.S.C. § 341 and § 360d(b) (FDA); 49 U.S.C. § 30111 (NHTSA); and 21 U.S.C. § 1035, § 1036, § 453, § 456, § 601, and § 608 (USDA). 52 See 15 U.S.C. § 2066(b) and (h), and § 2066(a-b) (CPSC); 21 U.S.C. § 381(a), § 381(m) and (o) (FDA); 7 U.S.C. § 7712(a), § 7713(a), § 8303(a), and § 8307(b) (USDA—live plants and animals); 21 U.S.C. § 620(a) (USDA—meat); 21 U.S.C. § 466(a) (USDA—poultry); 21 U.S.C. § 1046(a) (USDA—egg products). 53 FDA may deny an application to introduce a new drug into commerce in the United States if the application does not include reports of adequate testing by all methods reasonably applicable to show whether or not the drug is safe for use. See 21 U.S.C. § 355(b) and (e). Products under CPSC jurisdiction that are subject to a children‘s product safety rule must be tested by a third party. See 15 U.S.C. § 2063(a)(2). 54 15 U.S.C. §§ 2065(a) and 2066(g). 55 In general, imported egg products, poultry, and meat must be manufactured or processed in a foreign country that has obtained certification from FSIS indicating that it maintains a safety compliance program equivalent to that of the United States. See 21 U.S.C. § 466(d) and 9 C.F.R. Part 381, Subpart T (poultry); 21 U.S.C. § 620(f) and 9 C.F.R. Part 327 (meat products); 21 U.S.C. § 1046(a)(2) and 9 C.F.R. §§ 590.900—590.970 (egg products). Individual drugs and certain medical devices must obtain preapproval from FDA before they can be introduced, delivered, or marketed in U.S. commerce. See 21 U.S.C. § 355(a) and § 360(e). 56 See 49 U.S.C. § 30164; 49 C.F.R. Part 551. As noted in appendix II of this report, notice of an enforcement action is one of the necessary elements for establishing jurisdiction in a U.S. court. 57 In re Mattel, Inc., and Fisher-Price, Inc., CPSC Dk. No. 09-C00 19 (reprinted in 74 Fed. Reg. 28030 (June 12, 2009)). 58 In re First Learning Company, Ltd., CPSC Dk. No. 09-C0026 (Jul. 8, 2009). 59 According to CPSC, formal action against a foreign corporation must be served following the Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters. 658 U.N.T.S. 163 (November 15, 1965). 60 According to USDA officials, FSIS invested approximately $19 million in fiscal year 2009 to ensure the safety of imported products, which included costs for determining the equivalence of foreign inspection systems. 61 Agreement on the Application of Sanitary and Phytosanitary Measures, signed April 15, 1994, Final Act of the Uruguay Round of Multilateral Trade Negotiations, Marrakesh, Morocco. 62 See 21 U.S.C. § 355(a), § 360b(a), and § 360e. 63 See 21 U.S.C. §§ 393(b)(3), 383(b), and 360(i)(3). 64 FDA compliance programs are documents prepared by FDA centers that provide guidance to field staff in carrying out investigations, inspections, sample collections, sample analyses, and regulatory activities in defined program areas, such as domestic seafood and pesticides in domestic foods. 65 As stated above, all federal agencies with import regulatory responsibility are required to participate in the International Trade Data System, which, according to CBP, is intended to link these agencies to CBP‘s Automated Targeting System. 66 FSIS is developing a new risk-based public health inspection program it calls the Public Health Information System (PHIS) that will phase out AIIS. We did not independently review AIIS or PHIS. 67 We did not independently review OASIS. FDA is developing a new screening tool to replace the admissibility screening portion of OASIS it calls the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The PREDICT screening tool will be different from the legacy OASIS screening module in that it is designed to use multiple factors including automated data mining, pattern discovery, open source intelligence, and database queries of other FDA Center databases to calculate a risk score for import shipments. 68 Import alerts indicate particular risks that are screened for at U.S. borders and face potential refusal into the United States. FDA officials told us the agency may issue an import alert based on information from market surveillance, border inspections, or from information they obtain directly from foreign countries. 69 As of July 15, 2009, the Department of State has denied FDA‘s request to open an office in the Middle East.

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As of June 18, 2009, at http://www.fda.gov/InternationalPrograms/Agreements/ MemorandaofUnderstanding /default.htm. 71 In 2008, OECD sent out a questionnaire to its member nations on consumer product safety. The Analytical Report on Consumer Product Safety, DSTI/CP(2008)18/FINAL, OECD, 2008, was prepared to facilitate discussion of the questionnaire responses at the Roundtable on Consumer Product Safety, sponsored by the OECD Committee on Consumer Policy on Oct. 23, 2008. 72 GPSD aims at ensuring that only safe consumer products are sold in the EU. According to the EU, GPSD provides a broad definition of a safe product, and products must comply with this definition. In addition to the basic requirement to place only safe products on the market, producers must inform consumers of the risks associated with the products they supply. They must take appropriate measures to prevent such risks and be able to trace dangerous products. Under GPSD, the member states are obliged to enforce the requirements on producers and distributors. In addition to the power to impose penalties, the directive gives the surveillance authorities a wide range of monitoring and intervention powers. 73 According to the EU, half of all dangerous products seized by European customs and product safety authorities in 2008 came from China, and China is the EU‘s biggest supplier. 74 The EU‘s RAPEX system was established by the GPSD and applies to only nonfood consumer products. It is designed to ensure the swift transfer of information on dangerous nonfood consumer products found in one EU member state to the European Commission and to other member states. The system is intended to promote effective cross-border market surveillance. Once a dangerous product is found and stopped, the national contact point notifies national market surveillance authorities, customs authorities, and the European Commission. The commission validates the notification and then transmits the information to the other countries through the RAPEX system. 75 Summaries of these reports are publicly available at http://ec.europa.eu/consumers 76 The roundtable recommended greater coordination and cooperation within and among countries and multilateral organizations. In addition, the roundtable also recommended that governments take a more proactive approach to product safety failure, make greater efforts to harmonize product safety standards internationally, and work to develop a rapid international information exchange system. See OECD Roundtable on Consumer Product Safety—Summary Report, DSTI/CP (2009)1/FINAL, OECD (October 2008). 77 The Interagency Working Group on Import Safety, composed of representatives from 12 cabinet departments and agencies, including CPSC, was formed by executive order in July 2007. The working group issued its Action Plan for Import Safety on Nov. 6, 2007, which contained several recommendations designed to improve the safety of imported products. According to a CBP official, representatives from import safety agencies, including CPSC, continue to meet to implement certain recommendations of the action plan. 78 See ―Consumer Product Safety Commission Agenda, Priorities, and Strategic Plan: Request for Comments,‖ 74 Fed. Reg. 109 (Jun. 9, 2009). 79 We previously reported that when agencies have difficulty establishing outcome-oriented performance measures, they can develop intermediate measures that show how programs are contributing toward end outcomes. See GAO, Rail Safety: The Federal Railroad Administration Is Taking Steps to Better Target Its Oversight, but Assessment of Results Is Needed to Determine Impact, GAO-07-149 (Washington, D.C.: Jan. 26, 2007): 39-47. 80 South Korea is also a member of the International Consumer Product Safety Caucus, but due to resource constraints, we omitted Korea from our analysis. The EU is a customs territory, but we refer to it as a country in this report for ease of reference. 81 The most common means of establishing personal jurisdiction are (1) service of process on a defendant that is physically located within the territorial jurisdiction of the particular court; (2) service of process on a defendant that is not physically located within the court‘s territorial jurisdiction, but where such service is determined to be fair because the defendant has sufficient ―contacts‖ within the jurisdiction; or (3) a defendant‘s consent to personal jurisdiction. 82 For example, in June 2009, CPSC reached a $2.3 million settlement with Mattel, Inc., regarding the importation of toys manufactured in China that violated the Commission‘s Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint (Lead-Paint Ban), 16 C.F.R. Part 1303. In re Mattel, Inc., and Fisher-Price, Inc., CPSC Dk. No. 09-C00 19 (reprinted at 74 Fed. Reg. 28030 (Jun. 12, 2009). 83 See 658 U.N.T.S. 163 (November 15, 1965). 84 CPSC announced on August 4, 2009, that Techtronic Industries Co. Ltd., which is a foreign entity, agreed to pay a civil penalty in the settlement of litigation filed by the U.S. Department of Justice (on CPSC‘s behalf) in U.S. district court. In re United States v. Wagner Spray Tech Corp. and Techtronic Industries Co. Ltd., No. 08 Civ. 6478 (D. Minn. July 23, 2009). Also, in July 2009, CPSC reached a $50,000 settlement with First Learning Company, Ltd., a Hong Kong corporation with offices in the U.S., regarding the importation of toys manufactured in China that violated the Commission‘s Lead-Paint Ban. In re First Learning Company Ltd., CPSC Dk. No. 09-C0026 (Jul. 8, 2009). 85 The most common means of establishing personal jurisdiction are (1) service of process on a defendant that is physically located within the territorial jurisdiction of the particular court; (2) service of process on a defendant that is not physically located within the court‘s territorial jurisdiction, but where such service is

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determined to be fair because the defendant has sufficient ―contacts‖ within the jurisdiction; or (3) a defendant‘s consent to personal jurisdiction. 85 This table is not a comprehensive representation of all statutory or regulatory provisions applicable to a particular regulatory activity. In the absence of a primary statutory provision that expressly authorizes or prohibits a particular regulatory activity, we did not undertake an independent analysis to determine whether an agency is authorized to undertake such activity pursuant to a general grant of authority under the relevant implementing statute or otherwise. 86 Established by the President on July 18, 2007, the Interagency Working Group on Import Safety is composed of senior officials from twelve federal departments and agencies and is organized to continuously improve the safety of imported goods. To accomplish this, the group‘s strategy is to shift focus from intervention—actions taken when risks are identified—to prevention—actions to prevent harm in the first place. 87 In the EU, policy responsibilities lie with the EC— the executive arm of the EU, responsible for implementing its policies and running its programs. 88 Commission Decision 2008/329/EC (OJ L 114, 26.4.2008, 90). 89 COM (2008) 9. 90 On July 9, 2008, a new legislative framework for the marketing of products consisting of Regulation (EC) No. 765/2008 and Decision 768/2008/EC was adopted (OJ L 218, 13.8.2008, 30, 82). 91 The report suggests scope to develop the framework and further actions, outlining benefits which further coordinated market surveillance between the Member States would bring, given the increasingly global market. It also suggests that efficiency in addressing product safety issues would be increased if the Commission were enabled to act more quickly to create state-of-the-art standards for specific risky products and if a permanent ban could be imposed under the General Product Safety Directive on products or substances when a risk is generally recognized, rather than having to do this through further product specific Directives. 92 Report from the Commission to the European Parliament and to the Council on the Implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, Brussels, 14.1.2009, COM(2008)905 final. http://ec.europa.eu/consumers/safety/prod_legis/docs/report_impl_gpsd_en.pdf. 93 The drafting of specific EU standards is handled by three European standards organizations: the European Committee for Electrotechnical Standardization (CENELEC), the European Telecommunications Standards Institute (ETSI), and the European Committee for Standardization (CEN). 94 CNCA‘s English-language Web site is http://219.238.178.8/20040420/column/227.htm (accessed 7/6/09). It lists the types of products that require CCC tests.

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Chapter 2

CONSUMER PRODUCT SAFETY COMMISSION: CPSIA IMPLEMENTATION Bruce K. Mulock

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SUMMARY Created in the early 1970s, the Consumer Product Safety Commission (CPSC) is a small agency by Washington standards (less than 500 employees and a $80 million FY2008 appropriation) charged with a seemingly overwhelming responsibility: to protect American consumers against death or injury from unsafe products, including imported products. A series of high-profile product recalls during 2007—most notably of children‘s toys imported from China—focused attention on the CPSC‘s resources, including its legal authority, for the task at hand. In the 110th Congress, legislation (H.R. 4040 and S. 2663) to strengthen the Commission was considered, a conference agreement (H.Rept. 110-787) passed by both chambers, and Consumer Product Safety Improvement Act (CPSIA/P.L. 1103 14) was signed into law by President George W. Bush on August 14, 2008. In the coming years it is widely anticipated by those who drafted the CPSIA, by the CPSC itself, and by those who follow or have a stake in consumer product safety, that the new law will prove to be a turning point in the agency‘s history – one which significantly empowered the CPSC to better protect consumers against defective and unsafe products. Over the next several years, many of the more than three dozen provisions included in the CPSIA will be put to the test, not the least of which are restoring the original five-member Commission leadership approach, following the experiment begun in 1982 of reducing the number of Commissioners to three; empowering the 50 state attorneys general to enforce CPSC‘s regulations; and requiring the agency to provide consumers with a user-friendly database on deaths and serious injuries caused by consumer products. For the moment, however, one thing seems certain: implementation of the CPSIA is not going well. The CPSC has been overwhelmed with multiple statutory deadlines. Confusion is rampant among manufacturers, importers, distributors, retailers, and consumers about new lead limits for consumer products intended for children 12 and under. Turmoil is particularly

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acute among small businesses. Despite agency efforts to provide clarification, consignment shops, thrift stores, and various charitable organizations still fear incurring stiff fines for inadvertently violating the CPSIA, and retailers across the county are contemplating disposing of valuable inventory that may well pose no health risks. A coalition of trade associations, including the National Association of Manufacturers, petitioned the CPSC to delay a February 10, 2009 effective date and issue guidance to businesses about complying with CPSIA. While Acting Chairman Nancy Nord said she ―agree[d] that the effective date of this provision is problematic for many, the Consumer Product Safety Commission does not have the authority to stay the effective date. Any such change must be made by Congress.‖ Nevertheless, on January 30, the CPSC Commissioners did vote to provide ―limited relief‖ from enforcement of testing and certifications for one year for manufacturers and importers of regulated products, including products intended for children 12 years old and younger. The agency also issued on February 10 a revised guidance document that explains to small businesses, resellers, crafters, and charities their responsibilities under the CPSIA. House and Senate committee and subcommittee chairmen have exchanged correspondence with the two-person CPSC Commission about how best to resolve numerous compliance and enforcement questions and several bills have been introduced to deal with various issues.

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ABOUT THE AGENCY The Consumer Product Safety Commission is perhaps best understood in the context of the surge of the consumer protection movement of the 1 960s. Beginning with Ralph Nader‘s efforts to dramatize the problems of auto safety, a general interest in product safety was stimulated. Congress responded by passing a series of laws dealing with auto safety, toy safety, radiation safety, fabric flammability, and child resistant packaging for hazardous household substances. These laws—as well as several dating from the 1950s—were, in the opinion of some observers, neither comprehensive in scope with respect to the wide range of consumer products nor adequate in protection. While industry was originally opposed to a federal regulatory approach, by the early 1970s, the National Association of Manufacturers agreed there was a need for Congress to pass a product safety law.1 A key reason was because manufacturers were increasingly having to contend with a complex and confusing assortment of state laws, and the prospect of having to deal with a unified regulatory approach appeared attractive. Although there are other historical factors, the CPSC owes its existence primarily to the work of the National Commission on Product Safety (NCPS). Legislation was introduced in 1966 and the following year P.L. 90-146 authorizing the NCPS was approved. In March 1968, President Lyndon Johnson appointed the seven-member, bipartisan Commission to ―conduct a comprehensive study and investigation of the scope and adequacy of measures now employed to protect consumers against unreasonable risk of injuries which may be caused by hazardous household products.‖2 The agency‘s statutory purposes are to (1) protect the public against unreasonable risks of injury associated with consumer products; (2) assist consumers in evaluating the comparative

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safety of consumer products; (3) develop uniform safety standards for consumer products and minimize conflicting state and local regulations; and (4) promote research and investigation into the causes and prevention of product-related deaths, illnesses, and injuries. In addition to the authority assigned to the CPSC by its enabling legislation, major consumer programs were transferred to the new agency from the Food and Drug Administration, the Health, Education and Welfare Department (now known as Health and Human Services), and the Commerce Department. Included were the Federal Hazardous Substances Act of 1960, as amended by the Toy Safety Acts of 1969 and 1984 and the Child Protection Amendments of 1966, the Poison Prevention Packaging Act of 1970, the Flammable Fabrics Act of 1953, and the Refrigerator Safety Act of 1956. The CPSC was designed to be relatively small. Rather than relying on thousands of inspectors, the agency relies on the onus placed on firms by its enabling statute. Section 15(b), for example, requires manufacturers to report unsafe products to the Commission. This general approach appears to have worked reasonably well for domestically produced consumer products, because of the nation‘s regulatory regime. When it comes to imported products, however, the absence of key factors may make safety oversight more problematic. In China, for example, inspections cannot—with anything approaching confidence—be left to Chinese factory owners. China reportedly suffers from the absence of a rigorous regulatory system, endemic problems of corruption, and a lack of a free press.3

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CPSIA: MAJOR PROVISIONS The Consumer Product Safety Improvement Act represents a comprehensive, farreaching amending of the 1973 Consumer Product Safety Act. Although a thorough review of the CPSIA is beyond the scope of this report, the principal purpose of which is to provide context and insight into the key problems of the on-going implementation of the new law, it is useful to list the major provisions. [For a detailed examination of the CPSIA, the reader is referred to CRS Report RL34684, Consumer Product Safety Improvement Act of 2008: P.L. 110-314, by Margaret Mikyung Lee.] In brief, the CPSIA‘s major provisions include: Bans lead beyond a minute amount in products intended for children under 12 years of age. Prohibits use of dangerous phthalates in children‘s toys and child care articles. Mandates pre-market testing by certified laboratories of children‘s products for lead and for compliance with a wide range of safety standards. Requires manufacturers to place distinguishing marks on products and packaging to aid in recalls of products. Requires CPSC to provide consumers with a user-friendly database on deaths and serious injuries caused by consumer products. Strengthens protections against import and export of dangerous products, prohibits the sale and export of recalled products, improves public notice for recalls, and enhances tools for removing recalled products from store shelves. Bans 3-wheel all terrain vehicles (ATVs) and strengthens regulation of other ATVs, especially those intended for use by youth.

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Bruce K. Mulock Ensures that CPSC effectively shares information with State public health agencies. Bans industry-sponsored travel by CPSC Commissioners and staff, and authorizes a travel budget to address problems raised by the increasingly global market for consumer products. Restores the five-Member Commission, authorizes significant budget increases, and provides expedited rulemaking. Enhances national product safety enforcement by authorizing injunctive enforcement of federal law by State Attorneys General, preserving State common law causes of action and California‘s Prop 65 warning requirements. Provides whistleblower protections for private sector employees regarding alleged violations of any CPSC-enforced product safety requirements.

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CONGRESS ACTS TO STRENGTHEN CPSC Although major consumer groups such as the Consumer Federation of America, Consumers Union, and U.S. Public Interest Research Group had been voicing concern about the CPSC‘s declining budgets (in real terms) and staffing for decades, and had tried for years to persuade Congress to amend and strengthen the agency‘s powers, until the recent turmoil over dangerous imported products, they had made little headway.4 Their concern over the years is not surprising, in light of the agency‘s congressional appropriations history. In 1977, a mere three years after the Commission opened its doors, its funding level was $40 million ($95 million, in 2009 inflation-adjusted dollars). This amount enabled the CPSC to employ 900 individuals. Beginning in 1980, however, the agency‘s staffing level declined over the following three decades. By 2007, the agency‘s $62.27 million budget (considerably less than half of the $145 million it would have received had its early budgets kept up with inflation) supported a staff of 393 FTEs (from a high of 978 in 1980). Throughout the summer and fall of 2007, as more and more news stories focused on consumer injuries and product recalls, appropriators took note of the growing concerns about the adequacy of the agency‘s funding. At oversight and appropriations hearings in both the House and Senate, witnesses from consumer organizations, industry, and the agency were among those who advocated providing CPSC with more money to get the job done. The House, following the recommendation of the Appropriations Committee, proposed increasing the agency‘s appropriation to $66.83 million for FY2008. For its part, the Senate proposed $70 million. In the end, under the omnibus funding measure (H.R. 2764), CPSC received $80 million for FY2008, an increase of $17.7 million for FY2008, or 28%. The CPSIA authorizes very sizable funding increases over the next five years. The new law authorizes a series of budget increases to $136 million in 2014, and raises the CPSC‘s staff to 500 FTEs by 2013. For FY2010, the Administration has requested $105.4 million for the CPSC. Of the amount requested, $17 million is estimated for the new responsibilities and requirement set by the CPSIA, including the development of a consumer product safety database.

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CPSIA IMPLEMENTATION PLAGUED BY CONCERNS AND CONFUSION From its enactment in August 2008 through the fall of 2008, the CPSC‘s implementation of the CPSIA appeared to unfold relatively smoothly, based on press coverage. Occasional newspaper and magazine stories revealed emerging problems and concerns about possible adverse impacts on certain smaller firms.5 Also, the CPSC‘s General Counsel issued a number of Advisory Opinions and the agency published a host of Federal Register Notices.6 However, as the February 10, 2009 effective date for several CPSIA requirements neared— new requirements include lower lead limits of 600 ppm in children‘s products, phthalates limits of 1,000 ppm for certain products, and mandatory toy standards—more and more stories appeared in print and broadcast media warning about difficulties and expenses associated with complying with the new law. During January 2009, there was particular focus on the concerns of consignment shops, thrift stores, and charitable organizations. Further, numerous manufacturers and retailers, both large and small businesses, expressed confusion about a wide variety of subjects associated with implementation of the CPSIA, including safety certification of products, deadlines for lower lead limits, and whether some or all of the new regulations would be retroactive. Book publishers and manufacturers and dealers of All Terrain Vehicles (ATVs), motorcycles, and bicycles—among others—were also affected. A brief chronology of selected correspondence and decisions between and among Congress, the agency, and industry may prove instructive. The American Library Association (ALA) wrote to the CPSC on December 4, 2008, noting that the agency‘s General Counsel had sent an opinion to the Association of American Publishers which interpreted the CPSIA to include children‘s books and stating that ―all books designed or intended for children under the age of 12 need to be tested [for lead]‖7 Subsequently, the ALA has adopted the view that the CPSIA does not apply to libraries—a view which has been supported by a number of Members of Congress, and which has not been refuted by the CPSC.8 On December 18, 2008, a coalition of trade associations, including the National Association of Manufacturers, petitioned the CPSC to delay the February 10, 2009 effective date and issue guidance to businesses about complying with CPSIA. More specifically, they urged the agency ―to issue a comprehensive direct final rule on the requirements under § 101(b) of the Consumer Product Safety Improvement Act (CPSIA), including rules governing test methods, exemptions, and warning statements.‖9 The petition noted that many industries supported the CPSIA and its purpose of enhancing children‘s product safety, but that they had done so with the expectation that the new law ―would be implemented in an orderly, comprehensive manner‖ The petition alleges that the Commission had failed to provide manufacturers with the necessary information they need to comply with the CPSIA, and ―[w]ithout a well defined regulatory regime predicated on sound test standards, and science-based exclusions that protect children, the threat to small business and their employees is significant. Congress did not reasonably intend such consequences from a chaotic implementation of the CPSIA.‖10 On January 8, 2009, the agency issued a Guidance Intended for Resellers of Children‟s Products, Thrift and Consignment Stores.11 This document emphasized that the Commission‘s enforcement priorities focused on manufacturers, not on retail establishments

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which were selling or reselling consumer products. It attempted to dispel confusion by clearly stating that the CPSIA does not require resellers to test children‘s products in inventory for compliance with lead limits before they are sold. Nevertheless, the Guidance also went on to say: ―However, resellers cannot sell children‘s products that exceed the lead limit and therefore should avoid products that are likely to have lead content, unless they have testing or other information to indicate the products being sold have less than the new limit. Those resellers that do sell products in violation of the new limits could face civil and/or criminal penalties.‖ The Motorcycle Industry Council asked the Commission in a letter dated January 28, 2009, to issue a temporary final rule to exclude a class of materials found in motorcycles so that those products would not be in violation of the CPSIA.12 The CPSC‘s General Counsel responded on February 9, 2009, saying the CPSC lacks the authority to act on the MIC‘s request because the CPSIA did not grant the agency such powers.13 As with several other industry requests, the CPSC maintains that relief can only be provided by Congress. The question of whether motorcycles present a problem because of their lead content is illustrative of the current debate over the issue of responsibility for implementation of the CPSIA. Currently, dealers around the nation say they have taken roughly $100 million worth of child- sized bikes off showroom floors. Dealers fear stiff fines for selling non-compliant products— various components (including battery terminals and tire stems) exceed the new lead limits. The motorcycle trade association asked the CPSC to exclude their products. In turning down the request, Chairman Nord noted the CPSIA was ―quite prescriptive and gives us little administration flexibility.‖ The CPSC chief of staff, Joe Martyak, says the agency can exclude a product only if regulators determine that the use of the product will not result in the absorption of ―any‖ lead in the human body. The agency says only Congress, by amending the CPSIA, could exempt bikes. Some lawmakers say Congress never intended the law to be applied in this fashion, and claim the CPSC has the authority under the new law to exercise such discretion. Similarly, although Acting CPSC Chairman Nancy Nord said she agrees the effective date of various CPSIA provisions are problematic for many businesses, with respect to the lead limits, ―the Consumer Product Safety Commission does not have the authority to stay the effective date.14 Any such change must be made by Congress.‖ Nevertheless, on January 30, 2009, the CPSC Commissioners did vote to provide temporary, ―limited relief‖ from enforcement of testing and certifications for one year for manufacturers and importers of regulated products, including products intended for children 12 years old and younger. More specifically, the agency‘s enforcement stay applies to crafters, children‘s garment manufacturers, and toy makers that had been subject to CPSIA testing and certification requirements. The NAM coalition was critical of the agency action, claiming the enforcement stay only confuses the issue and ―may wrongly suggest to some that additional relief is no longer necessary.‖15 The coalition pointed out that the enforcement stay does not exempt manufacturers and others from complying with the CPSIA requirements, and therefore many retailers would be reluctant to sell products out of fear they might be prosecuted. The agency also issued on February 10, 2009, a revised guidance document which explains to small businesses, resellers, crafters, and charities their responsibilities under the CPSIA.16 The document is written in a question-and-answer format, and addresses testing and certification of children‘s products, exemptions to the lead content limits, and phthalates. It

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includes a table of commonly resold children‘s products and lists whether they are generally safe to sell. Despite weeks of back and forth between Members of Congress and the CPSC, it is still far from clear whether the problem is with the CPSIA itself or with the manner in which the CPSC is administering it. And, by the same token, it is uncertain whether the agency could resolve many of the issues itself, or if it is wholly a matter for Congress to decide. In responding to the January 16, 2009 committee chair letter, Nord asserted that the CPSIA was ―quite prescriptive and give us little administration flexibility.‖ The CPSC lost some of its ability to use discretion in its enforcement of the CPSIA, by virtue of the act‘s having empowered state attorneys general to enforce the CPSIA. What that means with regard to the agency‘s January 30, 2009 decision to stay certain testing and certification requirements is for now the chief example. The CPSC is powerless to command state attorney general to join in the stay. If a state attorney general decided to ignore the stay—and bring an action against a retailer for violating the CPSIA—the CPSC could not prevent such an outcome. In other words, even though the CPSC says it will delay for one year enforcement of certain testing and certification requirements for manufacturers and importers of regulated products, there is nothing to prevent a state attorney general from prosecuting the retailer for not testing— thereby ignoring the Commission‘s stay.

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CONGRESSIONAL INVOLVEMENT AND LEGISLATION Individually and collectively, Members of Congress have been working to resolve the problems and ameliorate the confusion associated with the implementation of the CPSIA. Committee chairs have written to the CPSC and to President Barack Obama on the subject, and several bills have been introduced in the 111th Congress to address the issues. On January 16, 2009, four Congressmen who chair committees and subcommittees with jurisdiction over the CPSC wrote to Acting Chair Nord and Commissioner Thomas Moore to implore the agency to quickly address CPSIA implementation issues .17 In addition to relating concerns held by the children‘s books and apparel industries, Senators John D Rockefeller and Mark L. Pryor and Representatives Henry A. Waxman and Bobby L. Rush asked that the agency speak to questions about guidance to re-sellers of children‘s products such as thrift and consignment stores; component part testing; and guidance to small businesses generally. Acting Chairman Nord18 and Commissioner Moore19 responded separately (in letters dated January 30 and February 3, respectively), with the latter saying that the two of them held different views and that, unfortunately, the agency did not speak with one voice. While both appear to be in complete agreement that the agency‘s staff has demonstrated hard work and professionalism in their effort to accomplish the CPSIA‘s ambitious goals, it also appears that Acting Chairman Nord alone thinks Congress needs to amend the CPSIA in several areas. She says ―the timelines in the law are proving to be unrealistic‖20 and only Congress

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can change the lead ban‘s retroactive application to existing inventories of charities, gift stores, and other small retailers. Further, mirroring what a number of critics have voiced, Nord noted the agency staff ―are finding that there are problems and issues that were not discussed, and presumably, not contemplated, by Congress.‖21 In turn, in a letter dated February 4, 2009, the four Congressmen stressed the critical need, in their view, for the CPSC ―to (1) establish a clear timeline for its decisionmaking in the coming year, spelling out what the Commission will need to accomplish in order to fully implement the law and (2) address continued confusion in the marketplace.‖22 The previous day (February 3) the same four Congressmen wrote to President Obama on the subject of the CPSIA, expressing their view that the CPSC needed a new Chairman, to wit:23 Unfortunately, the implementation process of the CPSIA has been grossly mishandled by Acting Chairman Nancy Nord. Without your intervention, the successful implementation of the CPSIA is not assured, and the policies and rules to protect the public health and safety of millions of children may not be realized. Therefore, we are writing to request that you ask Nancy Nord to step down from her current position as Acting Chairman of the CPSC, and that you immediately appoint a new Chairman who will vigorously and properly implement the CPSIA while addressing the other safety issues before the Commission.

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In their letter the Chairmen and Subcommittee Chairman of the Senate and House committees responsible for overseeing the CPSC argued that Nord‘s lack of leadership at the agency— particularly in ensuring that certain industries and firms received the information they need to comply with the CPSIA‘s safety requirements—had allowed misinformation to circulate about the new law, ―causing undue fear among businesses and consumers alike.‖24 The concluding paragraph of the three-page letter to the President spoke to the longstanding clash of views between Nord and the current congressional leadership of the committees with oversight responsibilities for the agency:25 The CPSC has been limited by leadership that has philosophically contradicted strengthening and improving this agency for far too long. Its mission is far too vital to rely on an Acting Chairman whose personal ideology, explicit acts, and deliberate inaction run counter to the very policy goals the CPSIA was intended to advance. For these reason, we respectfully request that you ask Nancy Nord to step down from her position as Acting Chairman and that you immediately present a designee for Chairmanship of the CPSC to the Senate for its approval.

Most recently, Congressman John D. Dingell, chairman emeritus of the House Committee on Energy and Commerce, requested in a March 4, 2009 letter to Acting Chairman Nord and Commissioner Moore that they respond to ten questions having to do with CPSIA implementation.26 First, speaking in general terms, Representative Dingell said: In particular, I am troubled that the Act (CPSIA) includes unrealistic deadlines for rulemakings and compliance, as well as too little implementation discretion for the Consumer Product Safety Commission (CPSC), both of which are exacerbated by the CPSC‘s lack of adequate resources, both in terms of funding and staff.

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Saying that he would appreciate their ―candid responses,‖ the letter‘s questions included these (excerpts): Question 1: To what extent has robust implementation of the act been hampered by CPSC‘s lack of resources? What levels of funding and staffing does CPSC believe [are] necessary for proper implementation of the act? Question 2: Given the paramount importance of ensuring children‘s safety and the overall mission of CPSC, to what extent are the deadlines in the act practicable for CPSC and industry to meet acting with all deliberate speed? If these deadlines are not practicable, what revisions to them does CPSC suggest? Question 3: Does CPSC have quantitative data concerning any negative impact of the act (i.e., the lead and phthalate limits and testing requirements) on small manufacturers of children‘s products, and if so, would CPSC please provide them? What information does CPSC have on any such negative impact of a more anecdotal nature?

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Question 4: Does CPSC have any suggestion for how to mitigate any such economic impact of the act on small manufacturers of children‘s products (e.g., component testing for lead and phthalate content) that, in accordance with the intent of the act and the CPSC‘s mission, will not compromise the health and safety of children using them? Question 5: What information has CPSC received about the impact of the act on the availability of second-hand products for children, especially clothing? It is my understanding that many second-hand stores now refuse to sell children‘s products. Does CPSC have any suggestions for how to mitigate any negative effects of the act on second-hand stores for children‘s products, especially in light of the recent economic downturn and the consequent increased need for low-cost sources of children‘s clothing? Question 7: Although some youth all-terrain vehicles (ATVs) and youth motorcycles are intended for use by children under 12 years of age, does CPSC believe it is necessary that these products be tested for lead and phthalate content? Similarly, does CPSC believe that these products present a risk to children for the absorption of phthalates or lead? Question 10: In general, does CPSC believe that the act was written with too little implementation discretion for the Commission? If this is the case, for which issues (e.g., third party testing requirements) does CPSC require more discretion? Although the letter imposed a March 13 deadline, an extension was subsequently negotiated among the parties.

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In a 21-page letter dated March 20, 2009, Acting Chairman Nord and career agency staff responded to Representative Dingell‘s letter, noting that ―we are seeing unanticipated issues arise‖ with each step the CPSC takes to implement the CPSIA.27 Indicating that matters are likely to get worse before they get better, Nord described something akin to a perfect storm. Saying the agency‘s being required to implement concurrently the CPSIA, the Virginia Graeme Baker Pool and Spa Safety Act, and the Children‘s Gasoline Burn Prevention Act, in combination with funding delays and limited personnel, has ―severely overstretched the agency staff and has begun resulting in delays in implementation.‖28 More specifically, the agency‘s response to the above questions included the following points:

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Question 1: Despite the CPSC‘s submission in August 2008 of an amendment requesting $21.1 million to the then-pending President‘s Budget Request through the Office of Management and Budget, as well as directly to Congress, to begin implementation of the CPSIA (with another request in November 2008), the agency received no additional funding during the crucial first six months. While the FY2009 omnibus appropriations conference report (H.R. 1105) includes $105 million for the CPSC (a $25 million increase over FY2008 funding), ―the six- month delay in funding will cause continued deferrals until such time that the agency fully absorbs the new appropriation.‖29 Question 2: In response to the question about how practicable the deadlines are and what does the CPSC suggest, the letter states that ―the deadlines mandated in the CPSIA have jeopardized our ability to meet Commission priorities and proven to be too much for a relatively small agency to handle all at once.‖30 The result: ―The deadlines have proven to be impracticable for our staff to meet and are presenting significant problems for the agency to solve. The commission staff must have some relief from the deadlines impose.‖31 The letter makes two suggestions, ―ideally in combination,‖ to ameliorate the problems noted. First, allow the CPSC to use risk assessment methodology to establish priorities, provide for common sense exemptions, and set CPSIA implementation deadlines. And, second, give the agency the discretion to move CPSIA effective dates. Question 3: While acknowledging that it only possesses anecdotal cost estimates, generally provided by industry, the agency nevertheless places the CPSIA‘s economic impact for inventory losses, lost sales, disposal costs, and other costs likely to be incurred by small manufacturers ―in the billions of dollars range.‖32 Suggesting the merits of defining the risk for given products by means of foreseeable use data plus mouthing and ingestion data, the staff notes: ―This approach would exclude items such as bikes and ballpoint pens from the discussion [so the agency] could focus on items like jewelry and other objects likely to be mouthed or ingested. By granting the CPSC the flexibility to determine the relevant hazards, flexibility in determining exemptions based on assessment of risks, and the discretion to adjust the age limit for certain groups of products where the exposure is low, resources can be properly focused on areas of greater risk, yielding maximum reductions in consumer risk of death and injury.‖ 33

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Question 4: The agency staff‘s key suggestion for mitigating the CPSIA‘s economic impact on small firms is to develop a robust component certification program. This would mean that companies would not need to test a product if the components have already been tested and shown to be compliant. In addition, Congress could choose to apply the new lead and phthalates limits prospectively to mitigate the impact on inventory existing prior to enactment. Question 5: With regard to second-hand products, the three principal problems facing consignment shops and thrift stores are delineated: testing everything they receive is not a practical solution; resellers cannot spread testing costs across many units of the same type; and, the standard tests for lead and phthalate content are destructive. Potential solutions, if they are to rectify the core problem, must address the retroactive nature of the law, according the CPSC staff. And inasmuch as such a fix is—in the opinion of the staff—beyond the agency‘s authority to solve, Congress must act.34

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Question 7: In response to Representative Dingell‘s question about All-Terrain Vehicles (ATVs), the CPSC staff noted the possibility of significant lead exposures from the vehicles as ―remote at best,‖ and it proposed five ways Congress could mitigate the impact of the new standards, including direct exemptions and granting the CPSC greater discretion to create exceptions.35 Question 10: Finally, as to whether the CPSC was given too little discretion in implementing the CPSIA, the staff response could not be more direct: ―The CPSIA provides too little implementation discretion for the agency.‖36 The letter goes on to state, ―The CPSIA forsakes the core strengths of the CPSC‘s original statutory framework [The Consumer Product Safety Act, P.L. 92-573] which has from the beginning allowed the Commission to prioritize its regulation of consumer products by an overall assessment of all the risks at stake, the magnitude of those risks, and the actual consequences of the hazard.‖37 In conclusion, the CPSC‘s March 20 letter suggests that three changes would resolve many of the major difficulties identified in the 21-page response: Limit the applicability of new requirements to products manufactured after the effective date, except in circumstances where the Commission decides that exposure to a product presents a health and safety risk to children. Lower the age limit used in the definition of children‘s products to better reflect exposure and give the CPSC discretion to set a higher age for certain materials or classes of products that pose a risk to older children or to younger ones in the same household. Allow the CPSC to address certification, tracking labels and other issues on a product class or other logical basis, using risk-assessment methodologies to establish need, priorities, and a phase-in schedule.

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of the new law.38 A March 24, 2009, statement by NAM‘s president, John Engler, said ―The law‘s unrealistic compliance deadlines made it impossible for industry or the CPSC to adequately prepare before the law went into effect. Its unprecedented decision to retroactively apply the new lead standards and phthalates ban to inventory already sitting in stores and warehouses is causing massive disruptions to industries across the board, particularly small and medium-sized companies.‖ In a March 27, 2009, letter to Acting Chairman Nord, Senator Dick Durbin took issue with several comments she made recently disparaging the CPSIA, and said, in part, ―As Chairman of the Financial Services and General Government appropriations subcommittee, I increased funding levels for the CPSC from $62 million for Fiscal Year (FY) 2007 to more than $105 million for FY2009. It distresses me that these new resources are being sent to an acting chairman who disdains the authority and opportunity the new law and funding provide.‖39 Acting CPSC Chairman Nord responded to Senator Durbin‘s letter, stating while ―the CPSIA contains a number of needed modernizations to the statutes administered by the Consumer Product Safety Commission,‖ the law ―also contains a number of new requirements for the agency that have unrealistically rigid deadlines....‖40 She also emphasized that the assessments and recommendations included in the agency‘s March 20 letter to Representative Dingell were those of the ―career staff of the agency.‖41 A rally was held on Capitol Hill on April 1, 2009, by a number of individuals representing various interests—including apparel makers, educational toy manufacturers, ATV dealers, motorcycle enthusiasts, book publishers, librarians, crafters, and other small business owners, as well as Members of Congress—who called on House and Senate leaders to amend the CPSIA.42 Major CPSIA concerns discussed by rally participants included the following:43 CPSIA Lacks Concept of Risk Assessment: the new law contains inflexible standards which are difficult or impossible to modify. Without consideration of quantifiable risk of injury, far too many safe products are swept up into the safety legislation‘s overly broad reach. Retroactive Application of New Standards: applying the new law retroactively caused widespread market chaos and significant business losses in a range of industries, as demonstrated by the range of rally participants. Unreasonable Implementation Timeline: the CPSIA left insufficient time for firms to sell off inventory or transition manufacturing standards. Lack of lead time led to large business losses. Further, CPSIA implementation deadlines did not provide the CPSC with sufficient time to manage the deluge of questions, certifications, rulemakings, etc. Overly Broad Definition of Children‘s Products: by defining children‘s products to include all consumer goods intended or designed for use by children up to 12 years of age, the CPSIA incorporates many categories of products not previously subject to regulation or know to present a quantifiable risk of injury to children. In addition to the congressional involvement noted above, several bills have been introduced in the 111th Congress which concern problems and issues associated with the implementation of the CPSIA. They are, as follows: Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

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S. 374: To amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned businesses, including exempting second-hand sellers from certain provisions, delaying various effective dates, waiving certain third-party testing requirements, and suspending enforcement pending the issuance of final regulations. Status: Read twice and referred to the Committee on Commerce, Science, and Transportation. S. 389: To establish a conditional stay of the ban on lead in children‘s products, and for other purposes Status: Read twice and referred to the Committee on Commerce, Science, and Transportation. S. 608: To amend the Consumer Product Safety Improvement Act to exclude secondary sales, repair services, and certain vehicles from the ban on lead in children's products, and for other purposes. Status: Referred to the Committee on Commerce, Science, and Transportation.

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H.R. 968: To amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned, including provisions similar to S. 374 (above) as well as waiving certain civil penalties for good-faith violations. Status: Referred to the House Committee on Energy and Commerce. H.R. 1027: To exempt second-hand sellers of certain products from the lead content and certification. Also directs the Government Accountability Office to conduct a study conduct a study on the application of consumer product safety standards, rules, and bans to specified used products and the impact that such application has on second-hand sellers. Status: Referred to the House Committee on Energy and Commerce. H.R. 1046: To ensure the effective implementation of children‘s product safety standards under the Consumer Product Safety Act. The bill also calls for the mandatory exclusion of fabric products from lead limits and for special considerations in the enforcement with respect to small businesses, thrift stores, and charities. Status: Referred to the House Committee on Energy and Commerce. H.R. 1465: To amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned businesses. Status: Referred to the House Committee on Energy and Commerce. H.R. 1510: To amend the Consumer Product Safety Act to provide an exemption for certain All-Terrain Vehicles, and for other purposes. Status: Referred to the House Committee on Energy and Commerce.

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Bruce K. Mulock H.R. 1692: To amend the Consumer Product Safety Act to exempt ordinary books from the lead limit in such Act. Status: Referred to the House Committee on Energy and Commerce. H.R. 1815: To clarify the applicability of certain provisions of the Consumer Product Safety Act, including prospective application of lead limits and third- party testing requirements. Status: Referred to the House Committee on Energy and Commerce.

End Notes 1

―Product Safety: Stricter Law in Congressional Mill,‖ Congressional Quarterly, Dec. 18, 1971, p. 2629. P.L. 90-146, Section 2(a), Nov. 20, 1967. 3 Edwin S. Steinfeld, ―The Rogue That Plays by the Rules,‖ The Washington Post, Sept. 2, 2007, p. B3. 4 The pattern of legislation being driven by a sudden increase in public awareness is well established. More than a century ago, for example, Upton Sinclair‘s book The Jungle (1906), which dealt with conditions in the U.S. meat packing industry and caused a public uproar, contributed to the passage of the Pure Food and Drug Act and the Meat Inspection Act of 1906. 5 For example, see Kiki Fluhr, ―New Law to Put Thousands Out of Work,‖ The Patriot Ledger, December 13, 2008, p. A9. Also: Lyndsey Layton and Annys Shin, ―Toymakers assail Costs of New Law: How Consumer Protections Will Be Implemented is Onerous, Manufacturers Say,‖ The Washington Post, December 21, 2008, p. A3. 6 Information about implementation of the Consumer Product Safety Improvement Act (CPSIA) available at http://cpsc.gov/about/cpsia/cpsia.html. 7 http://www.ala.org/ala/aboutala/offices/wo/woissues/governmentinfo/cpsia/AAP 8 For an overview of the issue and supporting documents, see http://www.ala.org/ala/aboutala/offices/wo/woissues/ governmentinfo/cpsia/cpsia.cfm. 9 http://www.toyassociation.org/AM/PDFs/Safety/CPSCPetition1208.pdf. 10 Ibid. 11 U.S. Consumer Product Safety Commission, Guidance Intended for Resellers of Children‟s Products, Thrift and Consignment Stores, Release #09-086, Washington, D.C., January 8, 2009, http://www.cpsc.gov/cpscpub/ prerel/ prhtml09/09086.html. 12 Available at http://cpsc.gov/library/foia/foia09/petition/pp37.pdf. 13 CPSC response available at http://cpsc.gov/library/foia/foia09/petition/pp37_resp.pdf. 14 Commission response to NAM petition available at http://www.cpsc.gov/LIBRARY/FOIA 15 ――CPSC Stays Enforcement of CPSIA Testing, Certification Requirements to February 2010‖,‖ BNA Daily Report for Executives, February 4, 2009, pp. 21 DER A-13. 16 Document available at http://cpsc.gov/about/cpsia/smbus/cpsiasbguide.pdf. 17 Letter to Acting Chairman Nord available at http://energycommerce.house.gov/images Newsroom/nord%20moore%202009%201%2016.pdf. 18 Acting Chairman Nord‘s response (hereafter cited as Nord January 30 letter) available at http://www.cpsc.gov/PR/ nord013009.pdf. 19 http://www.cpsc.gov/PR/Moore020309.pdf 20 See Nord January 30 letter, p. 2. 21 Ibid. 22 Members letter to Nord and Moore available at http://www.bamababiesandbirthdays.com/blog waxman_to_nord_moore_020409.pdf. 23 Members letter to the President available at http ://i.usatoday.net/money (hereafter cited as Obama letter) 24 Obama letter, p. 1 25 Obama letter, p. 3. 26 Rep. Dingell‘s letter to Nord and Moore available at http://www.house.gov/apps/list/press 090305CPSC.shtml. 27 Acting Chairman Nord‘s letter to Rep. Dingell available at http://cpsc.gov/about/cpsia/dingell032009.pdf 28 Ibid, p. 1-2. 29 Ibid., p. 2. 30 Ibid, p. 3.

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Ibid., p. 4. Ibid., p. 6. 33 Ibid., p. 8. 34 Ibid., p. 12. 35 Ibid., p13-15. 36 Ibid., p. 18. 37 Ibid., p. 20. 38 NAM statement re: CPSC response to Rep. Dingell is available at http://www.shopfloor.org/page/2/?s= CPSIA+Update. 39 Sen. Durbin‘s March 27 letter to Nancy Nord available at http://durbin.senate 310660. 40 Acting Chairman Nord‘s letter available at http://designer-entrepreneurs nord_responds_to_durbin.pdf. 41 Ibid., p. 1. 42 Information about the rally is available at: http://amendthecpsia.com. 43 http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090401005397& newsLang=en.

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In: Consumer Product Safety Commission Issues Editor: Isaac E. Bowman

ISBN: 978-1-60876-766-3 © 2010 Nova Science Publishers, Inc.

Chapter 3

BETTER DATA COLLECTION AND ASSESSMENT OF CONSUMER INFORMATION EFFORTS COULD HELP PROTECT MINORITY CHILDREN Government Accountability Office

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WHY GAO DID THIS STUDY In 2004, the U.S. Consumer Product Safety Commission (CPSC) estimated that 29,400 deaths in the United States were related to consumer products. As required under Section 107 of the Consumer Product Safety Improvement Act of 2008, this study reviews what is known about the relative incidence of preventable injuries and deaths among minority children associated with products intended for children's use and also examines what actions CPSC has taken through its public information and education initiatives to minimize these injuries and deaths. To address these issues, we assessed injury and death data sources used by CPSC, compared CPSC‘s consumer education efforts with key practices, and interviewed federal officials and groups representing the health and consumer interests of minority populations.

WHAT GAO RECOMMENDS GAO recommends that CPSC develop and implement cost-effective means of improving data collection on factors that may contribute to any differences in the incidence of consumer product-related injury and death. GAO also recommends that CPSC develop and implement cost-effective ways to enhance and assess the likelihood that safety messages are received and implemented by all the intended audiences. CPSC and the Department of Health and Human Services (HHS) agreed with GAO‘s recommendations. View GAO-09-731 or key components.

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WHAT GAO FOUND Few studies have assessed racial and ethnic differences in child death rates from injuries related to consumer products, and CPSC has not analyzed whether specific racial or ethnic groups are disproportionately affected by product hazards because of data limitations. These limitations include incomplete and inconsistent race and ethnicity data on emergency room reports and the inconsistent presence of product-related information on death certificates. In 2007, race and ethnicity data were not coded in about 31 percent of cases in CPSC‘s National Electronic Injury Surveillance System (NEISS), which collects data from a nationally representative sample of hospital emergency rooms. In addition, the hospitals that do record race and ethnicity information in CPSC‘s NEISS system do so inconsistently, in part because of limited CPSC guidance. While death certificates may include more complete race and ethnicity information compared with nonfatal injury data from hospitals, related product information is not consistently documented on the certificates. Despite this lack of data, CPSC has developed or modified some consumer information efforts to reach specific minority populations, but it has not assessed the results of these efforts. CPSC provides information in Spanish for many of its outreach efforts, including its telephone hotline, Web site, television, radio, and print publications. CPSC has also identified and established relationships with other organizations to help disseminate consumer safety information to minority communities. And while CPSC has used some consumer input to develop safety information, it has not assessed outreach efforts for specific audiences. CPSC has also established goals for its overall consumer information efforts, but not for its messages targeted to specific populations. In addition, CPSC relies on its Neighborhood Safety Network, a group of organizations that have expressed interest in receiving product safety information, to share information with audiences that can be hard to reach, but the agency has not assessed whether these populations are receiving and using the information. Organizations we contacted for this report, including Neighborhood Safety Network members and children‘s safety groups, generally reported using safety information provided by CPSC, but some offered suggestions for improvement of efforts to reach minority communities, such as providing safety information in other languages and additional exposure through broadcast media.

ABBREVIATIONS CDC CPSC CPSIA HHS IHS MCHB NEISS NCHS NSN

Centers for Disease Control and Prevention U.S. Consumer Product Safety Commission Consumer Product Safety Improvement Act Department of Health and Human Services Indian Health Service Maternal and Child Health Bureau National Electronic Injury Surveillance System National Center for Health Statistics Neighborhood Safety Network

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August 5, 2009 Congressional Committees The U.S. Consumer Product Safety Commission (CPSC), an independent federal agency charged with protecting the public from consumer products that pose an unreasonable risk of injury and death, estimated that 29,400 deaths in the United States related to consumer products occurred in 2004.1 CPSC works to fulfill its broad mission in part by conducting research into the causes and prevention of product-related deaths, illnesses, and injury and assisting consumers in evaluating the comparative safety of consumer products. CPSC has identified certain populations as vulnerable or hard to reach with safety information, including older Americans, urban and rural low-income families, new parents, and minority groups. Consumer groups and researchers have also suggested that minority children, particularly those living in low-income communities, may face an increased risk of death from injuries because of factors associated with living in poverty, such as poor living conditions and less access to health care, quality recreational activities, and safety devices. Similarly, reports from the Centers for Disease Control and Prevention (CDC) have documented racial disparities in injury-related death rates among children. The Consumer Product Safety Improvement Act of 2008 (CPSIA) established consumer product safety standards and other safety requirements for children‘s products. It also contained a provision requiring GAO to study disparities in the risks and incidence of preventable injuries and deaths among children of minority populations related to consumer products intended for children‘s use.2 Specifically, GAO is to look at preventable injuries and deaths related to suffocation, poisoning, and drowning, including those associated with the use of swimming pools and spas; toys; cribs, mattresses, and bedding materials; and other products intended for children‘s use. Minority populations specified in the mandate include Black, Hispanic, American Indian, Alaska Native, Native Hawaiian, and Asian/Pacific Islander.3 The mandate also required GAO to provide information about ways to minimize risks of preventable injuries and deaths among minority children, including through consumer education initiatives. To address this mandate, we examined (1) what is known about the relative incidence of preventable injuries and deaths related to drowning, poisoning, and suffocation associated with products intended for children‘s use among minority children compared with nonminority children, and (2) what actions CPSC has taken through its public information and education initiatives to minimize child injuries and deaths, including those in minority populations, related to products intended for children‘s use. To answer these questions, we reviewed studies and reports by the Institute of Medicine, federal agencies, researchers, and other organizations that assessed racial or ethnic differences in injury and death among children and related studies that discussed injury prevention programs targeted to minority populations.4 We reviewed injury and death data sources used by CPSC to estimate product-related injuries and deaths. We interviewed federal officials at CPSC and five Department of Health and Human Services (HHS) organizations to learn about their related programs and initiatives. In addition, we obtained information about injury data, racial and ethnic disparity issues, and injury prevention campaigns from researchers, representatives of injury prevention programs, consumer groups, and groups representing the health and consumer interests of minority populations. Finally, we reviewed CPSC documents and interviewed CPSC officials regarding the development, operation, and evaluation of the agency‘s consumer information efforts. We compared the processes used by

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CPSC with key practices identified by experts in GAO‘s previous work on consumer information and education.5 The key practices include defining goals and objectives; analyzing the situation; identifying stakeholders; identifying resources; researching target audiences; developing consistent, clear messages; identifying credible messengers; designing media mix; and establishing metrics to measure success. Appendix I explains our scope and methodology in more detail. We conducted this performance audit from December 2008 through August 2009 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

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BACKGROUND CPSC was created in 1972 under the Consumer Product Safety Act to regulate consumer products that pose an unreasonable risk of injury, assist consumers in using products safely, develop uniform safety standards for consumer products, minimize conflicting state and local regulations, and promote research and investigation into product-related deaths, injuries, and illnesses. CPSC oversees about 15,000 types of consumer products used in the home, in schools, and in sports and recreation. In fiscal year 2008, CPSC carried out its mission with a budget of about $80 million and 396 full-time employees. Prior to 2008, CPSC experienced significant budget cuts and a sharp decline in its staffing level from a high of 978 employees in 1980. Congress appropriated increased funding totaling about $105 million for fiscal year 2009. This appropriation funds a staffing level of 483 full-time employees, according to CPSC‘s 2010 budget request.

CPSC Efforts to Inform Consumers about Product Hazards CPSC uses different methods to inform the public about product recalls and safety practices that can help prevent product-related injuries (see figure 1). CPSC maintains a National Injury Information Clearinghouse that disseminates information to the public related to deaths and injuries associated with consumer products under the agency‘s jurisdiction. CPSC also warns the public about product hazards by announcing product recalls and providing other safety information through print and electronic media, a telephone hotline, electronic mail, and the Internet. For example, CPSC works with manufacturers to provide public notice of product recalls, in which a defective item is to be removed from store shelves and consumers are alerted to return the item for repair, replacement, or refund, or otherwise dispose of them. To further its reach, CPSC also provides safety information to broadcast outlets, such as radio and television stations, and to print media outlets. According to CPSC officials, CPSC has allocated approximately $1 million annually to support its consumer information efforts and has nine employees in the Office of Public Affairs, the office

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responsible for developing and implementing CPSC‘s consumer information efforts in consultation with CPSC‘s technical experts and other CPSC staff. Congress appropriated funding in 2009 to help CPSC administer the Virginia Graeme Baker Pool and Spa Safety Act, including about $2.4 million for a state grant program and over $4 million for a program to inform the public and pool owners of pool and spa hazards to prevent children from drowning. Recently passed legislation requires CPSC to improve its consumer information activities. For example, the Consumer Product Safety Improvement Act (CPSIA) requires CPSC to develop an online database that is publicly available and searchable by date, product name, model, and manufacturer. The database must contain reports of harm relating to the use of consumer products. CPSIA also specifies the information that must be included in a mandatory product recall notice, including details about related injuries and deaths. The act also authorizes CPSC to require manufacturers to give public notice in languages other than English, although this provision applies only to mandatory recalls, according to CPSC officials.6

Related Department of Health and Human Services Efforts While CPSC is charged with protecting the public from unreasonable risks of injury and death from the thousands of types of consumer products under the agency‘s jurisdiction, HHS offices and agencies also play a role in injury prevention by conducting injury prevention research and information campaigns, collecting injury data, and promoting the health of minority populations. For example, according to agency officials and documents, CDC and the National Institutes of Health support research on a variety of topics, including injury prevention, and have conducted public information campaigns to reduce childhood injury. CDC‘s National Center for Health Statistics (NCHS) collects information about injuries, including race and ethnicity characteristics, from death certificates in all 50 states and the District of Columbia, as well as from household surveys and health care provider surveys. The Maternal and Child Health Bureau (MCHB) and the Indian Health Service (IHS) finance public health services, including injury prevention programs. HHS offices and agencies also lead efforts aimed at understanding and addressing racial and ethnic disparities in health care, including rates of unintentional injury among minority groups. For example, HHS‘s Office of Minority Health serves as a focal point within HHS to coordinate efforts to improve racial/ethnic minority health and eliminate racial/ethnic health disparities. The Office of Minority Health is charged with providing leadership and coordination for offices of minority health operating in other HHS agencies and in states to reduce racial and ethnic health disparities, according to agency officials. CDC is the lead agency charged with measuring progress toward national HHS goals to eliminate disparities in injuries, disabilities, and deaths due to unintentional injuries and violence. Injury and Death Data Sources Used by CPSC CPSC collects and analyzes data on consumer product-related injuries and deaths for products under its jurisdiction to determine where hazards exist and how to address them. CPSC obtains most of its information on injuries from its National Electronic Injury Surveillance System (NEISS), which gathers information from a nationally representative sample of about 100 hospital emergency rooms. NEISS provides national estimates of the

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number and severity of emergency room-treated injuries associated with, although not necessarily caused by, consumer products in the United States. Characteristics coded in the NEISS system include the date of treatment; the patient‘s age, gender, race and ethnicity, injury diagnosis, body part affected, case disposition; incident location; as well as the product involved. In 2000, NEISS was expanded to provide data on all trauma-related injuries. The expanded data provide other federal agencies, researchers, and the public with more comprehensive information on injuries from all sources, not just consumer products. CPSC receives approximately $2 million each year from CDC to support this effort.

Sources: CPSC and Art Explosion (photos). Figure 1. CPSC Consumer Information Methods.

CPSC obtains most of its information on fatal injuries from death certificates. Information recorded on death certificates includes the date and place of death, cause of death, age, gender, race and ethnicity, and residence of the deceased. CPSC estimates the number of consumer product-related deaths from data collected by NCHS about all deaths through the National Vital Statistics System. Because of the complexity and volume of collecting information about all deaths, there is over a 2 year lag before NCHS mortality data become available. According to a CPSC official, to obtain more timely information, CPSC annually purchases about 8,000 death certificates directly from states for selected causes of

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death that the agency has determined are likely to be product- related, such as bicycle accidents or falls involving playground equipment. CPSC supplements information from the NEISS system and death certificates with reports from individual consumers and with data from private organizations such as fire prevention groups and poison control centers. CPSC collects approximately 4,600 additional reports from participating medical examiners and coroners throughout the country, about 7,400 news clips, and 14,300 other reports of product-related injuries and deaths from consumers, lawyers, physicians, fire departments, and other sources, according to its 2010 performance budget request.

FEW STUDIES ASSESS RACIAL AND ETHNIC DIFFERENCES IN CHILDREN’S RISK OF DEATH FROM INJURIES RELATED TO CONSUMER PRODUCTS, AND DATA LIMITATIONS CONSTRAIN CPSC ANALYSIS

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Few Studies Assess Racial and Ethnic Differences in Child Death Rates from Injuries Related to Consumer Products Although some research suggests racial disparities in child death rates resulting from general causes of injury—including drowning, poisoning, and suffocation—we identified few studies that assessed racial and ethnic differences in child death rates from injuries related to consumer products. The studies we identified included two that identified racial and ethnic disparities in drownings in swimming pools and a study that identified a disparity between black and white infants in the risk of suffocation or strangulation in bed. We did not identify any studies that compared the incidence of poisoning related to consumer products by children‘s race and ethnicity. While these studies identified racial and ethnic differences in death rates related to specific products, the researchers were not consistently able to consider all factors that may contribute to these differences, such as differences in exposure to the consumer products.

Drowning Mortality data reported by CDC suggest racial disparities in drowning rates, although these data do not specify whether the deaths involved consumer products. Drownings can occur in a variety of settings, such as natural water settings, swimming pools, bathtubs, and buckets. According to CDC, between 2000 and 2005, the fatal unintentional drowning rate of black children ages 5 to 14 was 3.2 times that of white children in the same age range. For American Indian and Alaska Native children, the fatal drowning rate was 2.4 times higher than for white children. One study, conducted by researchers from HHS‘s National Institutes of Health, CPSC, and a research institute, found racial and ethnic disparities in swimming pool drowning rates.7 This study examined circumstances surrounding 678 swimming pool drownings among U.S. residents aged 5 to 24 years that occurred between 1995 and 1998. The study used data

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collected by CPSC about drowning deaths from death certificates, medical examiner reports, and newspaper clippings.8 The study found that black non-Hispanic males and females had higher swimming pool drowning rates compared with white non-Hispanic males and females of comparable age. Drowning rates were highest among black males, often occurring during the day at public pools, and this increased risk persisted after controlling for differences in neighborhood income. Hispanic males also had higher rates of pool drowning compared with white non-Hispanic males, but they had lower rates compared with black non-Hispanic males of comparable age. The drowning rates among Hispanic females were similar to those of white non-Hispanic females. The drowning rates among foreign-born victims were higher than among American-born victims. The study concluded that targeted interventions are needed to reduce the incidence of swimming pool drownings across racial and ethnic groups; it particularly recommended adult supervision at public pools and swimming instruction to increase children‘s swimming ability. Another study examining racial disparities in drowning rates in specific locations found that after the age of 5 years, the risk of drowning in a swimming pool was greater among black males compared with white males.9 Specifically, this study analyzed death certificate data collected by CPSC and NCHS about U.S. drowning deaths of children aged up to 19 in 1995. This research found that among black males aged 5 to 19 years, about 37 percent of drowning deaths with known location of drowning were in swimming pools, while only 10 percent of similar drownings among white males occurred in pools.

Suffocation One study conducted by CDC researchers found that black infants were disproportionately affected by accidental suffocation and strangulation in bed (27.3 versus 8.5 deaths per 100,000 live births for blacks and whites, respectively).10 This study analyzed infant deaths occurring between 1984 and 2004 using CDC‘s National Center for Health Statistics mortality files containing information from all death certificates. Researchers only analyzed differences between black and white infants in this study because of concerns about misreporting of racial and ethnic identity on death certificates for other racial and ethnic groups.11 Although not reported by racial group, beds, cribs, and couches were reported overall as the most common sleep surfaces where accidental suffocation and strangulation deaths occurred.12 In addition, co-sleeping or bed sharing was reported in over half of the cases. The study concluded that efforts should target those at highest risk and focus on helping parents and caregivers provide safer sleep environments. Poisoning We did not identify any studies that compared the incidence of poisoning related to consumer products by children‘s race and ethnicity. CPSC has assessed differences in the incidence of product-related poisonings among children by age group and gender. A recent study conducted by CPSC staff found that 70 percent of an estimated 86,194 child poisoning incidents involving children less than 5 years of age treated in hospital emergency rooms that occurred in 2004 involved children 1 to 2 years of age; slightly more than one-half involved boys; and about 60 percent involved oral prescription drugs, nonprescription drugs, and supplements.13 The study concluded that while fatal child poisonings involving drugs and

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other hazardous household substances have decreased in recent years, nonfatal child poisonings treated in hospital emergency rooms have remained at high levels. Poisoning can also occur when children swallow or put in their mouths products that contain excessive levels of lead paint or lead content, such as toys or children‘s costume jewelry; however, CPSC receives little information about such incidents through its data systems.14 According to CPSC officials, the agency rarely receives reports of child lead poisoning through its data systems because lead poisoning usually appears as a chronic illness rather than an acute injury, and as we have previously reported, CPSC‘s data systems are not set up to capture information about chronic illnesses.15

CPSC Has Not Analyzed Racial and Ethnic Differences in Product-Related Injury and Death because of Data Limitations

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CPSC estimates product-related injury and death rates by age group, but because neither emergency room nor death certificate data provide complete information about both race and ethnicity and related products, CPSC has not analyzed product-related injury and death rates by race and ethnicity or other characteristics that could identify particularly vulnerable populations.16 While other federally supported data collection efforts provide more, or more reliable, information on the range of factors, including race and ethnicity, that may contribute to injury risk, these efforts have not collected data on consumer product involvement or CPSC has not been involved with them.

NEISS System While products related to patients‘ injuries are coded in the NEISS system, limited patient race and ethnicity information has hindered analysis of racial and ethnic differences in product-related injuries. CPSC‘s NEISS system specifies the products involved in injuries treated in hospital emergency rooms. NEISS coders can choose from approximately 900 product codes when identifying any products mentioned in hospital emergency room records, such as toys, cribs, and swimming pools. Consumer products are coded to allow for specificity. For example, a baby bathtub seat would be specified differently from a baby bath. In its 2008 performance report, CPSC reported conducting annual monitoring visits to all of the NEISS hospitals in its sample, concluding that data were collected on over 90 percent of product-related cases in emergency room records through the NEISS system. As shown in figure 2, our analysis of CPSC‘s NEISS data found that race and ethnicity data were not coded in about 31 percent of cases in 2007. The percentage of NEISS cases missing race and ethnicity information has prevented CPSC and CDC from assessing racial and ethnic differences in nonfatal injury rates, according to agency officials. According to a CPSC official, the agency has been aware of the missing race and ethnicity data and considered ways of statistically estimating race and ethnicity information using existing data, but has not pursued such analysis because of competing agency priorities.17

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Source: GAO analysis of CPSC‘s NEISS data. Note: Ninety-five percent confidence intervals are all less than or equal to plus or minus 0.2 percent.

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Figure 2. Estimated Percentage of NEISS Cases Missing Race and Ethnicity Information, 1999-2007.

Source: GAO analysis of CPSC‘s NEISS data. Figure 3. Portion of NEISS Hospitals with Various Percentages of Cases Not Coded for Race and Ethnicity, 2007.

Our analysis of CPSC‘s NEISS data found that some hospitals have a high percentage of cases missing race and ethnicity information. As shown in figure 3, about one-quarter of NEISS hospitals had more than 75 percent of cases missing race and ethnicity information in 2007.

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In addition, NEISS hospitals that have recorded race and ethnicity information do so inconsistently, in part because of limited CPSC guidance. For example, a NEISS coder in one NEISS hospital we visited reported that the hospital registrar would generally record the patient‘s race and ethnicity using visual observation and rarely verify this information with the patient. Staff at other NEISS hospitals reported that the admitting staff may ask for race or ethnicity data along with other information when the patient is checking into the emergency room. In its manual, CPSC does not specify how hospital staff should obtain the information about patient race and ethnicity, although some researchers suggest that information reported by patients or patient representatives is more accurate than visual observation by hospital staff. In addition, CPSC‘s coding system for race and ethnicity is limited to white, black, and a narrative field for ―other‖ categories, resulting in inconsistent coding and making data on other categories challenging to analyze. Our review of NEISS data found that NEISS hospitals use different terminology to code the same racial or ethnic categories in the ―other‖ category. According to a few organizations we interviewed, hospital-based collection of data on the race and ethnicity of patients is a challenge for several reasons. A hospital staff member from one NEISS hospital we visited said that these data are missing because hospital staff are uncomfortable asking patients about race and ethnicity. CDC officials and a researcher we interviewed said that hospital staff may not be trained to collect race and ethnicity information or may not understand that it is being used for purposes other than providing medical care. Other studies have found incomplete and inconsistent collection of information about patient race and ethnicity from hospitals. A panel convened by the National Academy of Sciences conducted a survey of hospitals and found that many hospitals report collecting race and ethnicity information, but these data are not reported to state and federal programs in a standardized format, and the information reported for racial and ethnic groups other than white and black may be unreliable.18 The panel recommended that HHS require health insurers, hospitals, and private medical groups to collect data on race, ethnicity, socioeconomic position, and acculturation and language and provide leadership in developing standards for collecting these data. Another qualitative study, funded by the California Endowment, reviewed hospital efforts to provide culturally and linguistically appropriate health care in 60 hospitals nationwide.19 The majority of hospitals reviewed in this study had inconsistent methods for collecting data on patient race, ethnicity, and primary language. In some hospitals, systems were in place but not used; in others, staff appeared not to have been trained on methods to accurately collect data from patients.

Death Certificates Death certificates may include more complete and accurate race and ethnicity information compared with nonfatal injury data from hospitals, according to CDC officials, but concerns remain about the accuracy of this information for some groups. The accuracy of race and ethnicity information recorded on death certificates has been studied over time. A recent evaluation conducted by CDC found that race and ethnicity reporting on death certificates has been excellent for white and black populations, poor for the American Indian or Alaska Native populations, and reasonably good for the Hispanic and Asian or Pacific Islander populations.20 According to CDC, studies have shown that individuals who selfreported as American Indian, Asian, or Hispanic on census and survey records were

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sometimes reported as white or non-Hispanic on the death certificate, resulting in an underestimation of deaths and death rates for the American Indian, Asian, and Hispanic groups. While death certificates may contain more complete and accurate race and ethnicity data than the NEISS system, according to CPSC and CDC officials, related product information is not consistently documented on the certificates. Unlike coders who enter data into CPSC‘s NEISS system, individuals who complete death certificates are not prompted or required to record information identifying specific consumer products related to the death. Information about product involvement may be found in the narrative recorded on the certificate; however, this information is not consistently recorded, according to both CPSC and CDC officials. CPSC has developed national estimates of consumer product-related death rates by age group using HHS data containing information about all deaths; but CPSC has not analyzed these deaths by race and ethnicity, according to CPSC officials. A CPSC official told us that CPSC staff could analyze consumer product-related deaths by race and ethnicity, although the agency has not done so to date. CDC officials said that given the limited information about product involvement found on death certificates, estimating product-related death rates by race and ethnicity could produce underestimates. Some states are collecting information about product-related deaths as part of investigations to understand the causes of child deaths; however, CPSC has not been involved in this effort. HHS‘s Maternal and Child Health Bureau funds a Web-based system and technical assistance center to support state collection of data from child death reviews, including race and ethnicity, type of injury, and details on product involvement. Child death reviews involve state and local officials from multiple disciplines sharing information to better understand child deaths and prevent future deaths. Since 2002, HHS‘s Maternal and Child Health Bureau has funded the National Maternal Child Health Center for Child Death Review, a technical assistance center that developed the Child Death Review Case Reporting System. As of February 2009, 28 states have used the system, and states vary in the types of deaths reviewed, the timing of entry into the system, and the amount of detail entered into the system, according to officials. The system prompts the user to record whether the death was a consequence of a problem with a consumer product and, if so, collects information about the product and whether the incident was reported to CPSC. However, according to officials, CPSC has not been involved in the development and implementation of this system. CPSC does not currently receive updates from HHS or the states directly through the Child Death Review Case Reporting System. According to CDC, injury data collected from household interviews through its National Health Interview Survey may include more accurate data on race and ethnicity compared with medical records-based data collection efforts because the information is self-reported or reported by a knowledgeable representative. The National Health Interview Survey also contains information about other factors that could account for health conditions, such as socioeconomic status, but lacks consistently reported information about product involvement, according to CDC officials. A CPSC official said the agency has not pursued working with CDC to augment its data collection efforts by modifying this survey, citing doubts that the data collected could include sufficient detail about product involvement even if the survey were modified.

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CPSC HAS DEVELOPED OR MODIFIED SOME CONSUMER INFORMATION EFFORTS TO REACH SPECIFIC MINORITY POPULATIONS, BUT HAS NOT ASSESSED THE RESULTS OF THESE EFFORTS CPSC has incorporated some elements of key consumer education practices to provide consumer product safety information to minority populations, such as periodically using consumer and other stakeholder input to inform its outreach efforts, but it has not specifically defined goals or developed measures to assess whether these efforts are effectively reaching minority populations (see app. II for further detail on the key practices).

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CPSC Has Tailored Some Outreach for Hispanic Communities and Established Relationships to Assist in Reaching Other Minority Populations CPSC‘s consumer information efforts are intended to provide notice of product recalls and guidance on safely using products to the general public, although some of its safety information regarding children‘s products has also been targeted to minority populations, particularly the Hispanic community. CPSC provides information in Spanish for many of its outreach efforts, and according to CPSC officials, has hired a Hispanic media consumer outreach specialist to assist with translations and to work with the Hispanic media, and has established practices to develop and disseminate safety information to this community. CPSC officials also told us that they provide information to Spanish-language television and radio stations, use Spanish-speaking telephone operators for CPSC‘s toll-free hotline, and maintain a language bank to provide assistance for calls in other languages.21 During fiscal year 2008, CPSC records indicate that CPSC hotline staff answered 1,570 calls in Spanish. The main CPSC Web site also includes a section called El Mundo Hispano de la CPSC with recall notices and other product safety information in Spanish. See figure 4 for examples of CPSC consumer information in Spanish and English. CPSC has also identified and established relationships with other organizations to help disseminate consumer safety information to additional minority communities through electronic, broadcast, and print media. For example, CPSC officials noted that in 2000, CPSC worked with the Bureau of Primary Health Care, Gerber, and Black Entertainment Television (BET) to launch a safe sleep campaign to help lower sudden infant death syndrome (SIDS) rates, especially among African-Americans. The campaign included a nationwide television public service announcement about placing babies to sleep on their backs to prevent SIDS, and special programming to be televised on BET. CPSC has also worked on media outreach campaigns with other organizations such as public health agencies, industry groups, and child safety organizations. In 2004, CPSC launched the Neighborhood Safety Network (NSN), to enlist support from community-based organizations in extending its messages to communities it designated as hard to reach, including older Americans, urban and rural low-income families, new parents, and minority groups. According to CPSC officials, CPSC uses NSN, now numbering about 5,600 member organizations, to deliver information to minority populations. Membership in NSN is free and enrollment is voluntary. Some of the member

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organizations include HHS, hospitals and health clinics, day care centers, fire stations, parent organizations, and American Indian reservations. CPSC has developed a Web page offering online safety materials that NSN members can modify for use with specific groups. NSN member organizations receive CPSC‘s e-mail updates with product safety information on topics such as drowning prevention, crib and toy safety, and poison prevention and may elect to employ these in their own outreach efforts.

NSN poster on safe sleep (in English)

NSN poster on safe sleep (in Spanish)

NSN poster on drowning prevention (in English)

NSN poster on drowning prevention (in Spanish)

Source: CPSC Web site. Figure 4. Examples of CPSC Consumer Information.

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Organizations we contacted for this report, including NSN members, consumer groups, and organizations that conduct injury prevention research or implement injury prevention programs in diverse communities generally reported using safety information provided by CPSC, and some offered suggestions for improving efforts to reach minority communities. Some of the organizations said that they receive information from CPSC via e-mail notifications, and some mentioned distributing flyers or posters provided by CPSC and incorporating information from CPSC into their own pamphlets and brochures. Some suggestions to improve consumer information efforts for minority populations included additional exposure through broadcast media because access to electronic information via computers may be limited. Some NSN members also said it would be useful if safety information were provided in additional languages. According to CPSC officials, the agency does not have the resources to translate information into additional languages, but one NSN member we interviewed mentioned that their organization had translated some CPSC materials for its audiences. Some organizations also expressed interest in collaborating more closely with CPSC on its consumer information efforts.

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CPSC Has Used Some Consumer Input to Develop Safety Information, but Has Not Assessed Outreach Efforts to Specific Audiences CPSC has periodically conducted audience research to strengthen its consumer information efforts. In 2003, the agency funded a literature review to examine the factors influencing consumers‘ understanding of and responses to recall notices and other safety information. The study findings suggested ways product recall communications could be improved to help consumers eliminate or reduce product hazards, such as using pictures and signal language like ―warning‖ or ―danger‖ to help consumers attend to and understand safety messages. CPSC also created an online Consumer Opinion Forum that consumers can join to provide feedback on product safety issues, such as how a recall notice could be written more clearly; however, consumers must have Internet access to participate in this forum. In addition, CPSC recognizes that to understand the culture and diversity within the Hispanic community, it must take certain steps such as interviewing members of the community, reviewing related research, and consulting with colleagues from other federal agencies. For example, to translate and adapt materials for one of its outreach campaigns for different segments of the Spanish-speaking audience, CPSC conducted interviews with members of the Hispanic community from varying educational backgrounds. Although CPSC has periodically conducted audience research, agency officials told us they do not have the resources to regularly pretest safety messages. However, officials from a few organizations we interviewed noted that CPSC could conduct focus groups with members of the target audience or include representatives of organizations that work with the target audience on an advisory committee to help design and implement safety campaigns. CPSC has also established goals for its overall consumer information efforts, but not for its messages targeted to specific populations. In its 2008 performance and accountability report, CPSC stated that its goal for using consumer information was to alert the public to children‘s and other hazards through consumer outreach, press releases, and conducting nine public information efforts that included topics such as drowning and poisoning prevention.

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CPSC sets annual performance goals that measure the success for each of these consumer information methods according to the total number of items issued, viewed, or conducted during that fiscal year. For example, CPSC set a fiscal year 2008 goal to receive 450 million views of its safety messages through television appearances, video news releases, and downloads of e-publications. CPSC relies on the Neighborhood Safety Network to share product safety information with audiences that can be hard to reach, but the agency has not formally assessed whether these populations are receiving and using the information. And while CPSC tracks the number of views its safety messages receive, CPSC officials stated that they do not collect information on audience demographics, which could indicate the target audiences being reached. Likewise, CPSC has conducted surveys to assess customer satisfaction with its tollfree hotline, Web site, and partnerships with state government agencies, and these surveys indicate a high level of satisfaction with CPSC services; however, these surveys do not collect information about the demographic characteristics of the consumers using CPSC‘s services to determine the extent to which they are representative of the general population. According to CPSC officials, CPSC has also not identified outcome measures to evaluate how well its campaigns affected the attitudes and behaviors of the target audiences it set out to influence. We previously identified strategies used by other federal agencies to evaluate the effectiveness of information campaigns, including analyzing findings from previous research, collaborating with program partners to help meet the information needs of diverse audiences and expand the usefulness of evaluations, and surveying the intended audience to ask about program exposure, knowledge, and attitude change.22 CPSC officials have also cited a lack of resources as a challenge to establishing evaluation programs to measure results; however, CPSC has recently received more resources from the fiscal year 2009 appropriation for the Virginia Graeme Baker Pool and Spa Safety Act. In the course of our review, CPSC officials stated that with this new funding for the act, they planned to include an evaluation component, but as of the writing of this report, it was not yet known how CPSC planned to implement this component.

CONCLUSIONS Protecting children from dangerous consumer products is a critical part of CPSC‘s mission. Some research suggests that there are racial and ethnic disparities in child death rates due to injuries related to particular consumer products; however, CPSC does not routinely assess whether such disparities exist, primarily because data limitations make it challenging to conduct such analyses. In addition, the lack of information about other characteristics of individuals who are injured or die from involvement with a consumer product, such as socioeconomic status, prevents CPSC from identifying potential underlying causes of racial and ethnic differences in injury and death rates. Without efforts to augment or improve existing data, CPSC may not know which groups are most vulnerable to product-related injury or death. If available data are improved, CPSC may be better able to identify hazards that disproportionately affect certain communities and develop ways to reduce those hazards. Despite limited information on racial and ethnic differences in product- related injury and death, CPSC has made some special efforts to deliver some of its consumer information to

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Better Data Collection and Assessment of Consumer Information Efforts Could… 101 audiences the agency identified as hard to reach, including minority groups. However, CPSC has not collected information on whether these targeted groups are receiving and acting on the safety information. Without fully assessing its consumer education and public outreach campaigns, CPSC cannot know how effective these initiatives are at reaching intended audiences, some of which may be at an elevated risk of injury or death.

RECOMMENDATIONS FOR EXECUTIVE ACTION

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To better understand the relative risk of product-related injury among minority and nonminority children, we recommend that the Commission, in consultation with HHS, Develop and implement cost-effective means of improving CPSC‘s data collection on factors that may contribute to differences in the incidence of injury and death related to specific types of consumer products, including race, ethnicity, and other patient characteristics. For example, steps CPSC could consider include improving the NEISS racial and ethnic classification system; working with NEISS hospitals to improve collection of data on patient race and ethnicity; and leveraging related data collection efforts, such as those sponsored by the Maternal and Child Health Bureau, the National Center for Health Statistics, or the National Institutes of Health. To improve the effectiveness of consumer information efforts, we recommend that the Commission, Develop and implement cost-effective ways to enhance and assess the likelihood that CPSC‘s safety messages are received and implemented by all the intended audiences. For example, CPSC could consider convening groups of consumers or Neighborhood Safety Network members to advise on the design and implementation of campaigns targeted to specific communities, surveying NSN members, establishing metrics to measure NSN‘s success, and evaluating the effectiveness of information campaigns targeted to the racial and ethnic groups at highest risk of drowning as part of its implementation of the Virginia Graeme Baker Pool and Spa Safety Act.

AGENCY COMMENTS AND OUR EVALUATION We provided a draft of this report to CPSC and HHS for review and comment. CPSC and HHS concurred with our recommendations and provided technical comments, which we incorporated as appropriate. A letter conveying HHS‘s comments is reproduced in appendix III.

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Government Accountability Office List of Committees The Honorable John D. Rockefeller, IV Chairman The Honorable Kay Bailey Hutchison Ranking Member Committee on Commerce, Science and Transportation United States Senate The Honorable Henry A. Waxman Chairman The Honorable Joe Barton Ranking Member Committee on Energy and Commerce House of Representatives

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The Honorable Mark Pryor Chairman The Honorable Roger Wicker Ranking Member Subcommittee on Consumer Protection, Product Safety, and Insurance Committee on Commerce, Science and Transportation United States Senate The Honorable Bobby L. Rush Chairman The Honorable George Radanovich Ranking Member Subcommittee on Commerce, Trade and Consumer Protection Committee on Energy and Commerce House of Representatives

APPENDIX I. OBJECTIVES, SCOPE, AND METHODOLOGY The objectives of this report were to examine (1) what is known about the relative incidence of preventable injuries and deaths related to drowning, poisoning, and suffocation associated with products intended for children‘s use among minority children compared with nonminority children, and (2) what actions the Consumer Product Safety Commission (CPSC) has taken through its public information and education initiatives to minimize child injuries and deaths, including those in minority populations, related to products intended for children‘s use. To address the first objective, we reviewed injury and death data sources used by CPSC to estimate product-related injuries and deaths. We reviewed data and documentation obtained from CPSC concerning its databases that contain injury and death data, including the

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Better Data Collection and Assessment of Consumer Information Efforts Could… 103 Death Certificates database, National Electronic Injury Surveillance System (NEISS), Injury or Potential Injury Incidents file, and In-Depth Investigations file.23 We reviewed information describing Department of Health and Human Services (HHS) mortality data, which includes information from death certificates filed in the United States collected through the National Vital Statistics System. We also reviewed HHS household and health care provider surveys that include injury data, such as the National Health Interview Survey and the National Hospital Discharge Survey. We also interviewed CPSC officials, HHS officials, and researchers to gather information about the strengths and weaknesses of available data sources. We assessed the completeness and reliability of the NEISS data set by (1) reviewing NEISS‘s technical documentation and methodological reports, (2) interviewing CPSC officials, (3) examining these data for obvious inconsistencies, and (4) visiting three NEISS hospitals to better understand how the data are coded. We determined that these data were sufficiently reliable to use as sources of summary statistics about the extent of missing race and ethnicity information in the NEISS system. To determine the extent of missing race and ethnicity information in CPSC‘s NEISS system, we analyzed NEISS data obtained from CPSC for the years 1999-2007. To explore available data published in related studies, we searched relevant databases, including PubMed, ProQuest, PsycFirst, and ScienceDirect. We also consulted with CPSC and HHS staff to identify related studies. We limited the scope of our work by looking at studies published since 1999. Through this process, our literature search identified about 70 studies, but only 3 studies published data on racial and/or ethnic differences in child injury or death rates related to specific consumer products, and we conducted detailed reviews of these studies. Our reviews entailed an assessment of each study‘s research methodology, including its data quality, research design, and analytic techniques, as well as a summary of each study‘s major findings and conclusions. We also assessed the extent to which each study‘s data and methods supported its findings and conclusions. To address the second objective, we reviewed CPSC documents and interviewed CPSC officials regarding the development, operation, and evaluation of the agency‘s consumer information efforts. Specifically, we reviewed CPSC‘s Web site, and documents such as CPSC customer satisfaction surveys, press releases, strategic plans, and performance and accountability reports. We compared the processes used by CPSC with key practices identified by experts in GAO‘s previous work as important to planning a consumer education campaign, motivating a target audience, and alleviating challenges in a campaign (see app. II for a description of these practices). We interviewed federal officials at CPSC and five HHS organizations—Centers for Disease Control and Prevention, Indian Health Service, Maternal and Child Health Bureau, National Institutes of Health, and the Office of Minority Health—to learn about their related programs and initiatives. In addition, we interviewed representatives of injury prevention programs, consumer groups, and members of CPSC‘s Neighborhood Safety Network to obtain their views on CPSC‘s efforts to provide product safety information to minority communities. We conducted this performance audit from December 2008 through August 2009 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe

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that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

APPENDIX II. KEY PRACTICES FOR CONSUMER EDUCATION PLANNING In a 2007 GAO report on consumer issues pertaining to the digital television transition, a panel of 14 senior management-level experts in strategic communications identified and came to consensus on key planning components for consumer education and outreach (see table 1). Table 1. Key Practices for Planning Consumer Education Campaigns Key practice Define goals and objectives Analyze the situation

Identify stakeholders

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Identify resources Research target audiences

Develop consistent, clear messages Identify credible messengers Design media mix

Establish metrics to measure success

Description Define the goals of the communications campaign, e.g., to increase awareness or motivate a change in behavior. Define the objectives that will help the campaign meet those goals. Analyze the situation, including any competing voices or messages, related market conditions, and key dates or timing constraints. Review relevant past experiences and examples to identify applicable ―lessons learned‖ that may help to guide efforts. Identify and engage all the key stakeholders who will be involved in communications efforts. Clarify the roles and responsibilities of each stakeholder, including which entity or entities will lead overall efforts. Identify available short- and long-term budgetary and other resources. Conduct audience research, such as dividing the audience into smaller groups of people who have relevant needs, preferences and characteristics, as well as measuring awareness, beliefs, competing behaviors, and motivators. Also, identify any potential audience-specific obstacles, such as access to information. Determine what messages to develop based on budget, goals, and audience research findings. Develop clear and consistent audience messages; test and refine them. Identify who will be delivering the messages and ensure that the source is credible with audiences. Plan the media mix to optimize different types of media such as news stories, opinion editorials, and broadcast, print, and Internet advertising. Identify through which methods (e.g., advertising in newsprint ads), how often (e.g., weekly or monthly) and over what duration (e.g., 1 year) messages will reach audiences. Establish both process and outcome metrics to measure success in achieving objectives of the outreach campaign. Process metrics ensure the quality, quantity, and timeliness of the contractor‘s work. Outcome metrics evaluate how well the campaign influenced the attitudes and behaviors of the target audience(s) that it set out to influence.

Source: GAO-08-43.

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APPENDIX III. COMMENTS FROM THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Related GAO Products Feasibility of Requiring Financial Assurances for the Recall or Destruction of Unsafe Consumer Products. GAO-09-512R. Washington, D.C.: April 22, 2009. Traffic Safety: Improved Reporting and Performance Measures Would Enhance Evaluation of High-Visibility Campaigns. GAO-08-477. Washington, D.C.: April 25, 2008. Digital Television Transition: Increased Federal Planning and Risk Management Could Further Facilitate the DTV Transition. GAO-08-43. Washington, D.C.: November 19, 2007. Health Care: Approaches to Address Racial and Ethnic Disparities. GAO-03-862R. Washington, D.C.: July 8, 2003. Program Evaluation: Strategies for Assessing How Information Dissemination Contributes to Agency Goals. GAO-02-923. Washington, D.C.: September 30, 2002. Internet: Federal Web-based Complaint Handling. GAO/AIMD-00-238R. Washington, D.C.: July 7, 2000. Consumer Product Safety Commission: Injury Data Insufficient to Assess the Effect of the Changes to the Children‟s Sleepwear Safety Standard. GAO/HEHS-99-64. Washington, D.C.: April 1, 1999. Lead Poisoning: Federal Health Care Programs Are Not Effectively Reaching At-Risk Children. GAO/HEHS-99-18. Washington, D.C.: January 15, 1999. Children‟s Health: Elevated Blood Lead Levels in Medicaid and Hispanic Children. GAO/HEHS-98-169R. Washington, D.C.: May 18, 1998. Consumer Product Safety Commission: Better Data Needed to Help Identify and Analyze Potential Hazards. GAO/HEHS-97-147. Washington, D.C.: September 29, 1997.

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End Notes

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1

CPSC has jurisdiction over consumer products used in and around the home and in sports, recreation, and schools, including many products intended for children‘s use, such as toys, swimming pools, cribs, and beds. However, CPSC does not have jurisdiction over all consumer products, such as car seats protecting children in on-road vehicles, automobiles, foods, drugs, cosmetics, and boats. 2 Pub. L. No. 110-314, § 107. 3 Racial and ethnic categories defined in Office of Management and Budget standards for maintaining, collecting, and presenting federal data on race include American Indian or Alaska Native, Asian, Black or AfricanAmerican, Native Hawaiian or Other Pacific Islander, and White. There are two categories for data on ethnicity: Hispanic or Latino, and Not Hispanic or Latino. Hispanic or Latino refers to a person of Spanish culture or origin, regardless of race. 4 The Institute of Medicine is a branch of the National Academy of Sciences, a private nonprofit organization made up of subject matter experts that advises the federal government on scientific and technological matters. 5 For details, see GAO, Digital Television Transition: Increased Federal Planning and Risk Management Could Further Facilitate the DTV Transition, GAO-08-43 (Washington, D.C.: Nov. 19, 2007). 6 CPSC rarely uses its authority to seek a mandatory recall. All of the 563 product recalls conducted in 2008 were voluntary, with CPSC negotiating a corrective action plan with the responsible companies. 7 Gitanjali Saluja, Ruth A. Brenner, Ann C. Trumble, Gordon S. Smith, Tom Schroeder, and Christopher Cox, ―Swimming Pool Drownings Among US Residents Aged 5-24 Years: Understanding Racial/Ethnic Disparities,‖ American Journal of Public Health (2006), 96(4):728-733. 8 Although the race of the victim was included as a precoded field on death certificates, researchers used data on death certificates about place of birth, nationality, and country of origin to more specifically code ethnicity. 9 Ruth A. Brenner, Ann C. Trumble, Gordon S. Smith, Eileen P. Kessler, and Mary D. Overpeck, ―Where Children Drown, United States, 1995,‖Pediatrics, (2001), 108: 85-89. 10 Carrie K. Shapiro-Mendoza, Melissa Kimball, Kay M. Tomashek, Robert N. Anderson, and Sarah Blanding, ―US Infant Mortality Trends Attributable to Accidental Suffocation and Strangulation in Bed From 1984 Through 2004: Are Rates Increasing?‖ Pediatrics (2009), No. 2, 123: 533-539. 11 See also E. Arias, W. Schauman, K. Eschbach, P. Sorlie, and E. Backlund, ―The Validity of Race and Hispanic Origin Reporting on Death Certificates in the United States,‖ Centers for Disease Control and Prevention, National Center for Health Statistics, Vital and Health Statistics (2008), 2(148). 12 Accidental suffocation and strangulation in bed is a subgroup of sudden, unexpected infant deaths, a leading category of injury-related infant deaths. 13 Robert L. Franklin, MS, and Gregory B. Rodgers, PhD, Directorate for Economic Analysis, US Consumer Product Safety Commission, Bethesda, Maryland, ―Unintentional Child Poisonings Treated in United States Hospital Emergency Departments: National Estimates of Incident Cases, Population-Based Poisoning Rates, and Product Involvement,‖ Pediatrics (2008), Vol. 122 No. 6. 14 Elevated blood lead levels are associated with harmful health effects in children, such as impaired mental and physical development. 15 GAO, Consumer Product Safety Commission: Better Data Needed to Help Identify and Analyze Potential Hazards, GAO/HEHS-97-147 (Washington, D.C.: September 1997). 16 We previously found that CPSC uses its data to identify rates of injury and death by age group, but not other characteristics, to assess which consumer product hazards have a disproportionate effect on vulnerable populations, such as persons with disabilities. For details, see GAO/HEHS-97-147. 17 Developing accurate estimates of product-related injury rates by racial and ethnic group could be challenging given existing CPSC data and data collection methods. Adequate numbers of cases from each racial and ethnic group are needed to develop accurate rates of product-related injury, and developing such rates could be a challenge in smaller minority groups. In addition, CPSC data systems do not collect other information that could explain differential rates of injuries treated in hospital emergency rooms, such as access to health insurance. 18 Michele Ver Ploeg and Edward Perrin, eds., Eliminating Health Disparities: Measurement and Data Needs (Washington, D.C.: The National Academies Press, 2004). 19 A. Wilson-Stronks and E. Galvez, Exploring Cultural and Linguistic Services in the Nation‟s Hospitals: A Report of Findings. (Oakbrook Terrace, Ill.: Joint Commission, 2007). 20 E. Arias, W. Schauman, K. Eschbach, P. Sorlie, and E. Backlund, ―The Validity of Race and Hispanic Origin Reporting on Death Certificates in the United States,‖ Centers for Disease Control and Prevention, National Center for Health Statistics, Vital and Health Statistics (2008), 2(148). 21 According to CPSC officials, CPSC‘s language bank is a working list of CPSC staff members who have proficiency in other languages. 22 GAO, Program Evaluation: Strategies for Assessing How Information Dissemination Contributes to Agency Goals, GAO-02-923 (Washington, D.C.: Sept. 30, 2002).

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Government Accountability Office

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Chapter 4

CONSUMER PRODUCT SAFETY IMPROVEMENT ACT OF 2008: P.L.110-314 Margaret Mikyung Lee

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SUMMARY Public alarm about the spate of recent product recalls throughout 2007, particularly of toys and other products used by children, has focused attention on the Consumer Product Safety Commission (the CPSC or the Commission). This scrutiny led to consideration of major amendments to the Consumer Product Safety Act (CPSA), which established and authorized the CPSC in 1972 in response to growing concerns about protecting the public from unsafe, defective consumer products. Jurisdiction over the administration and enforcement of several existing consumer safety statutes was transferred from other agencies to and consolidated under the CPSC. However, in the years since its establishment, the staff and resources of the CPSC have been considerably reduced, leading many observers to doubt its ability to fulfill its mission effectively. Consequently, Congress considered major reform legislation to address organizational and systemic deficiencies. Legislative proposals in the 110th Congress included provisions targeting specific consumer product defects and hazards. On July 29, 2008, H.Rept. 110-787, the Conference Report for H.R. 4040, the Consumer Product Safety Improvement Act of 2008 (CPSIA), was released after several months of negotiations in the conference committee to reconcile differences between the House and Senate versions of the bill. The bill passed the House of Representatives and the Senate on July 30, 2008 (424-1) and July 31, 2008 (89-3), respectively. On August 14, 2008, President Bush signed the bill into law as P.L. 110-314. CPSC Chairman Nord and Commissioner Moore each expressed approval of the final legislation, with Chairman Nord expressing a desire for Congress to appropriate further funding to carry out the new mandates of the legislation. This report provides an overview of the prior authority of the CPSC to establish consumer product safety standards and to inspect and recall unsafe consumer products, and discusses P.L. 110-314, the Consumer Product Safety Improvement Act of 2008, reforming

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the CPSC and strengthening enforcement of consumer product safety standards. It supersedes CRS Report RL34399, Consumer Product Safety Improvement Act of 2008: H.R. 4040, by Margaret Mikyung Lee (out of print but available from author). For an overview and context of the current issues facing the Commission, see CRS Report RS2282 1, Consumer Product Safety Commission: Current Issues, by Bruce K. Mulock. For an overview of issues regarding safety of consumer products imported from China, see CRS Report RS22713, Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview, by Wayne M. Morrison. For an overview of the issue of phthalates in children‘s products, see CRS Report RL34572, Phthalates in Plastics and Possible Human Health Effects, by Linda-Jo Schierow and Margaret Mikyung Lee.

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BACKGROUND Public alarm about the spate of product recalls during 2007, particularly of toys and other products used by children, has focused attention on the Consumer Product Safety Commission (CPSC). P.L. 110-314, 122 Stat. 3016 (2008), the Consumer Product Safety Improvement Act of 2008 (CPSIA), was enacted as a result of Congress‘s consideration of major reform legislation to address organizational and systemic deficiencies, as well as specific consumer product defects and hazards. This report provides an overview of the prior authority of the CPSC to establish consumer product safety standards and to inspect, recall, and restrict importation of unsafe consumer products, and summarizes changes made by the CPSIA to reform the CPSC and strengthen enforcement of consumer product safety standards. The Consumer Product Safety Act (CPSA, 15 U.S.C. §§2051 et seq.) established and authorized the CPSC in 1972 in response to growing concerns about protecting the public from unsafe, defective consumer products. However, in the years since its establishment, the staff and resources of the CPSC have been considerably reduced to the detriment of its ability to fulfill its mission effectively. Aside from the issue of adequacy of resources, the highly publicized recalls of children‘s toys in 2007 focused attention on alleged weaknesses in the CPSA and the authority of the CPSC to establish consumer product safety standards and to inspect, recall domestically, and block imports of unsafe consumer products. The CPSC is the central, federal authority for the promotion and enforcement of consumer product safety. The system is designed to be a collaborative effort among the CPSC, the industries producing the broad range of consumer products, and the consuming public. The CPSC researches and promotes best practices for the industries, producing guidelines for manufacturers, importers, distributors and retailers. Although the CPSA authorizes the CPSC to promulgate mandatory consumer product safety standards, it mandates reliance upon voluntary standards whenever compliance with voluntary standards would eliminate or adequately reduce the risk of injury and substantial compliance with voluntary standards is likely. Besides the CPSA, the CPSC also administers several other statutes whose authorities and functions were transferred to the CPSC upon its creation. The Federal Hazardous Substances Act (FHSA, 15 U.S.C. §§1261 et seq.) provides for warning/informational labeling of hazardous substances and for the banning of certain hazardous substances for

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which labeling would not provide adequate protection for the public against the potential hazards posed by the substances. The Flammable Fabrics Act (FFA, 15 U.S.C. §§1191 et seq.) provides for the establishment of safety standards regarding fabric flammability. It also prohibits the manufacture, sale, importation, transportation, or delivery in commerce of a product, fabric, or related material or of a product made of a fabric or related material that does not comply with the standards and deems that such practices constitute unfair methods of competition and unfair and deceptive acts or practices under the Federal Trade Commission Act. The Poison Prevention Packaging Act (PPPA, 15 U.S.C. §§1471 et seq.) authorizes the CPSC to establish special packaging standards for a household substance if such standards are required to protect children from serious injury or illness from using, handling or ingesting such substance, with exceptions for noncomplying packages for elderly/handicapped persons and packaging at the direction of a licensed medical practitioner. The Refrigerator Safety Act (RSA, 15 U. S.C. § § 1211) prohibits the introduction into interstate commerce of any household refrigerator that does not conform with certain safety standards. Prior to amendment by the CPSIA, some of these statutes provided for powers that were similar but not identical to those established under the CPSA. Therefore, the regulatory procedures and other actions which the CPSC is authorized to carry out with regard to the products regulated under these other statutes differed (and may still differ in some respects) from those authorized under the CPSA. Before the CPSIA, the CPSC could choose to regulate under the CPSA a consumer product that could be regulated sufficiently under these other statutes only if the CPSC determined that it was in the public interest to do so. The differences among the different statutory standards and procedures and enforcement authority arguably led to inconsistency in the enforcement of different product standards. For example, injunctive enforcement authority for states attorneys general is expressly provided by the FHSA and the FFA, but was not expressly provided by the CPSA before amendment by the CPSIA. The apparent ambiguity of the CPSA on this point led to amendments in the CPSIA to provide express authority. The CPSC has the authority to establish consumer product safety standards for consumer products generally, defined as ―any article or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.‖1 There are express exemptions for products covered under other statutes, including tobacco and tobacco products, motor vehicles and motor vehicle equipment, pesticides, firearms/antique firearms and ammunition/supplies (except for fireworks), aircraft and components, boats and other marine vessels, drugs, medical devices, cosmetics, food, or any article which is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer. The CPSC also has jurisdiction over amusement rides that are not permanently fixed to a site but rather are part of a travelling carnival or show, but does not have jurisdiction over rides that are permanently fixed to a particular site.2 Furthermore, the CPSC has no jurisdiction to regulate a particular consumer product if the risk of injury associated with that product could be eliminated or sufficiently reduced by actions taken under the Occupational Safety and Health Act of 1970 (Occupational Safety and Health Administration), under the Atomic Energy Act of 1954 (the Energy Research and Development Administration [now Department of Energy] and the

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Nuclear Regulatory Commission), or under the Clean Air Act (the Environmental Protection Agency). The CPSC has no authority to regulate any risk of injury associated with electronic product radiation emitted from an electronic product if such risk may be regulated under the Public Health Act (the Food and Drug Administration). Manufacturers, distributors, retailers, and importers are obligated to report consumer product safety problems to the CPSC, which may order a recall or import ban. The CPSA provides the general authority of the CPSC over inspections, recalls and import bans for consumer products generally, with the exceptions noted above, unless other statutes provide other agencies with authority over specific products. Although some of the other statutes enforced by the CPSC contain provisions specifically addressing notice/recall, import bans, and other remedies similar to those contained in the CPSA, not all do. The CPSC is authorized to inspect domestic facilities where a consumer product is manufactured and the conveyances by which it is transported and which may be relevant to the safety of such product.3 It is unlawful for a person to fail or refuse to permit inspection as required under the CPSA.4 For purposes of the CPSA, including inspection and testing, the CPSC may purchase any consumer product and it may require any manufacturer, distributor, or retailer of a consumer product to sell the product to the CPSC at cost.5 The CPSC is authorized to establish and maintain a permanent product surveillance program, in cooperation with other appropriate Federal agencies, for the purpose of carrying out the CPSC‘s responsibilities under the CPSA and the other Acts it administers and preventing the entry of unsafe consumer products into the United States.6 The U.S. Customs and Border Protection (CBP)7 is authorized to obtain and deliver samples of consumer products being offered for importation to the CPSC, upon its request, for the purpose of inspecting such samples for compliance with the CPSA.8 Similarly, under FHSA § 14 (15 U.S.C. § 1273), the CBP is authorized to obtain and deliver samples of hazardous substances being imported or offered for importation to the CPSC, upon its request, for the purpose of inspecting such samples for compliance with the FHSA. Under CPSA § 19,9 it has been unlawful, among other things, to manufacture, sell, distribute in commerce, or import into the United States any consumer product which does not comply with an applicable consumer product safety standard or which has been declared a banned hazardous product by a rule under the CPSA. Other consumer-product-related statutes contain similar provisions concerning prohibited or unlawful acts. The CPSIA has expanded the scope of prohibited acts. Under CPSA § 15,10 every manufacturer (defined to include importers), distributor, or retailer of a consumer product distributed in commerce who obtains information reasonably supporting the conclusion that such product (1) fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard; (2) contains a defect which could create a substantial product hazard; or (3) creates an unreasonable risk of serious injury or death, shall immediately inform the CPSC, unless such manufacturer, distributor, or retailer has actual knowledge that the CPSC has been adequately informed of such defect, failure to comply, or risk. If the CPSC determines after a hearing that a product presents a substantial product hazard and that notification is required in order to adequately protect the public from such substantial product hazard, the CPSC may order the manufacturer or any distributor or retailer of the product to take any one or more of the following actions: (1) to give public notice of the defect or failure to comply; (2) to mail notice to each person who is a manufacturer, distributor, or retailer of such product; or (3) to

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mail notice to every person to whom the person required to give notice knows such product was delivered or sold. The CPSIA expanded the scope of these provisions to cover noncompliance with rules under all acts under CPSC jurisdiction and to provide additional means of providing public notice. Prior to the CPSIA, if the CPSC determined after a hearing that a product presented a substantial product hazard and that action under that provision was in the public interest, it could order the manufacturer or any distributor or retailer of such product to take whichever of the following actions it elected to take: (1) to bring the product into compliance with the applicable product safety rule or repair the defect; (2) to replace the product with an equivalent product that does comply or is not defective; or (3) to refund the purchase price. The CPSIA removed the ability of the manufacturer, distributor or retailer to choose the remedial action to be taken and provides for the CPSC to determine which action should be taken. In addition to its authority with regard to a substantial product hazard, under CPSA § 12, the CPSC may bring an action in federal district court to have a product declared an imminent hazard, defined as a consumer product which presents imminent and unreasonable risks of death, serious illness, or severe personal injury, and to seize the product. If the court determines that a product constitutes an imminent hazard, it may grant any relief necessary to protect the public, including an order requiring public notification, recall, and remedies including repair, replacement, or refund of such product. Under the FHSA § 15,11 the CPSC may order a manufacturer, distributor, or dealer to take remedial action with respect to a banned hazardous substance similar to remedies under the CPSA, including (1) giving public notice that an article or substance is a banned hazardous substance; (2) mailing notice to each person who is a manufacturer, distributor, or dealer of such article or substance; and (3) mailing such notice to every person to whom the person giving the notice knows such article or substance was delivered or sold. The CPSC may also order the repair of such article or substance, replacement with an equivalent compliant article or substance, or refund. Similar notification and remedial actions may be ordered with respect to any toy or other article intended for use by children that is not a banned hazardous substance but that contains a defect which creates a substantial risk of injury to children. The CPSC does not pay for the costs of a notice of product hazard or defect or any ordered repair, replacement, or refund; costs are born by the manufacturer, distributor, or retailer. An order issued under CPSA § 1512 with respect to a product may require any person who is a manufacturer, distributor, or retailer of the product to reimburse any other person who is a manufacturer, distributor, or retailer of such product for such other person‘s expenses in connection with carrying out the order, if the CPSC determines such reimbursement to be in the public interest. Also, no charge shall be made to any person (other than a manufacturer, distributor, or retailer) who avails himself of any remedy provided under an order concerning repair, replacement, or refund, and the person subject to the order shall reimburse each person (other than a manufacturer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses incurred by such person in availing himself of such remedy. FHSA § 14(d)13 contains reimbursement provisions similar to CPSA §15.14 Any person who is a manufacturer, distributor, or dealer of a noncompliant toy, article, or substance may be ordered to reimburse any other person who is a manufacturer, distributor, or dealer of such toy, article, or substance for such other person‘s

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expenses in connection with carrying out a remedial or notification order, if the CPSC determines such reimbursement to be in the public interest. Also, no charge shall be made to any person (other than a manufacturer, distributor, or dealer) who avails himself of any remedy provided under a remedial order and the person subject to the order shall reimburse each person (other than a manufacturer, distributor, or dealer) who is entitled to a remedy for any reasonable and foreseeable expenses incurred in seeking such remedy. CPSC has the authority to establish import standards and policy with regard to statutes and products under its jurisdiction.15 Under the CPSA, importers are made subject to the same responsibilities as domestic manufacturers in protecting American consumers from unreasonably hazardous products. This is explicitly stated in the definition of ―manufacturer‖ as any person who manufactures or imports a consumer product.16 Like the CPSA, the FHSA and the FFA assign responsibilities to importers comparable to those of domestic manufacturers and distributors.17 Various statutory provisions authorize the CPSC to ban noncompliant imports. If the CPSC determines after a hearing that a product presents a substantial product hazard and that action under that provision is in the public interest, it may issue an order prohibiting the importation into the United States of that product.18 An imported consumer product may be refused admission to the United States if it does not comply with an applicable consumer product safety rule; does not comply with labeling and certification requirements relating to applicable product safety standards; is an imminently hazardous product; or has a product defect which constitutes a substantial product hazard. 19 The CPSC may then inform the CBP20 that an imported consumer product fails to comply with an applicable consumer product safety rule and/or has a product defect which constitutes a substantial product hazard and may request the CBP to refuse admission to any such consumer product.21 As discussed in this report, the CPSIA has expanded grounds for refusing admission to a product. Under FHSA § 14,22 a misbranded hazardous substance or banned hazardous substance being imported or offered for import shall be refused importation. Section 9 of the Flammable Fabrics Act (FFA)23 provides that imported products subject to flammability standards under the FFA shall not be released from customs custody except in accordance with § 499 of the Tariff Act of 193024 providing for release only after inspection by CBP for compliance with U.S. laws. The CBP also has authority for the redelivery or recall of products already released under bond but later found not to comply with flammability standards and for obtaining liquidated damages for breach of a condition of the bond arising out of a failure either to correct the product to comply or to redeliver it. Such noncompliant or defective products must be destroyed or exported from the United States unless they can be modified by the owner or consignee in a manner that will enable them to be granted admission into the United States.25 The CPSC and the CBP have the authority to give the owner or consignee the opportunity to make such modifications and to monitor such modifications.26 Prior to the CPSIA, such products could also be ordered destroyed at the discretion of the CPSC. The CPSIA made destruction mandatory, unless the CBP permits export in lieu of destruction and the product is exported within 90 days of such permission.27 Before the CPSIA, at its discretion, the CPSC could condition importation of a consumer product on the manufacturer‘s/importer‘s compliance with the inspection and recordkeeping requirements of the CPSA. The CPSIA makes compliance with such requirements mandatory, meaning that an imported product must be refused entry into the United States if the importer does not comply with requirements related to its product.28 The CPSC may seek an injunction or seizure of a consumer product that does not comply with a

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consumer product safety rule or that is being manufactured, sold, distributed, or imported in violation of a CPSC order for remedial action or prohibiting importation.29 With regard to imported products that are admitted and subsequently become the subject of a recall, if the CPSC is not able to exercise jurisdiction over a foreign manufacturer that has no U.S. subsidiary/presence, the CPSC may order the importer to undertake a recall and to be responsible for the expense of a mandatory recall, since ―manufacturer‖ is defined to include importers under the CPSA.30 The importer cannot obtain reimbursement under the CPSA, but might be able to obtain reimbursement from the foreign manufacturer as a contractual matter.31 Under CPSA §17(f),32 the owner or consignee of an imported consumer product denied entry into the United States must pay for all expenses in connection with its storage or destruction. In default of such payment, these expenses shall constitute a lien against any future importations made by such owner or consignee. Under FHSA § 14(c),33 the owner or consignee must pay for all expenses (including travel, per diem, or subsistence, and salaries of officers or employees of the United States) in connection with the destruction of a hazardous substance denied importation into the United States; the supervision of the relabeling or other action authorized to bring a hazardous substance denied importation into compliance with the FHSA so that it may be granted importation; and the storage for any hazardous substance denied importation. In default of such payment, the FHSA, like the CPSA, provides that such expenses shall constitute a lien against any future importations made by such owner or consignee.34 The Office of Compliance and Field Operations within the CPSC conducts compliance and administrative enforcement activities under all administered acts, provides advice and guidance on complying with all administered acts, and reviews proposed standards and rules with respect to their enforceability.35 Among other things, it reviews consumer complaints, conducts inspections and in-depth investigations, and analyzes available data to identify those consumer products containing defects that pose a substantial risk of injury or do not comply with existing safety requirements. The Office negotiates and monitors corrective action plans for products that are defective or fail to comply with specific regulations. The Office of International Programs and Intergovernmental Affairs within the CPSC was established to enable a more coordinated and comprehensive approach to international cooperation with regard to harmonization of safety standards internationally and the ensuring of compliance with U.S. safety standards for products imported into the United States. Memoranda of understanding have been concluded with CPSC counterparts in various countries or regional groups, including the People‘s Republic of China, the European Union, and Canada. The CPSC held a public meeting on September 4, 2008, to explain their plans to implement the CPSIA and will continue to hold a series of such meetings.36

CURRENT LEGISLATION: P.L. 110-314 There have been a number of proposals in the 110th Congress to address a range of consumer product safety issues. In addition to the two major CPSA reform bills that ultimately resulted in P.L. 110-314, H.R. 4040 and S. 2045/S. 2663,37 there have been other comprehensive reform bills and bills addressing discrete issues, including safety standards for

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cigarette lighters, All-Terrain-Vehicles or ATVs, furniture, swimming pools, portable gasoline containers, durable infant or toddler consumer products such as strollers and cribs, and other products; certification of safety- standard compliance; the enactment of lead content standards for consumer products and more stringent lead in paint standards; third-party testing for product safety and compliance; increases in civil and/or criminal penalties; increases in CPSC personnel assigned to ports-of-entry; the prohibition of sales or resales of products that are the subject of a recall; expanded jurisdiction of the CPSC to cover amusement park rides at a fixed site; greater coordination among the various agencies involved in consumer safety issues; and others. Language from some of the free-standing bills addressing specific issues was incorporated into the CPSIA. The following sections will summarize the provisions of P.L. 110-314. The final text was the result of a lengthy conference negotiation. The Senate-passed version of H.R. 4040 [hereinafter Senate Text]38 and the House-passed version of H.R. 4040 [hereinafter House Text]39 contained many similar provisions strengthening the authority and resources of the CPSC and also establishing standards concerning lead content in children‘s toys. However, the Senate Text contained additional reform provisions, such as whistleblower protection and several provisions concerning consumer product safety standards for specific items such as all-terrain vehicles and garage door openers. Conversely, most of the provisions of the House Text had parallel provisions in the Senate Text; the major exception was the provision adding a prohibition on industry-sponsored travel by members or employees of the CPSC, a response to the much-criticized practice by the CPSC of accepting travel and lodging expenses from industry sponsors for trips related to CPSC business, that was widely reported after the S. 2045 markup. On July 29, 2008, H.Rept. 110-787, the Conference Report for H.R. 4040, the Consumer Product Safety Improvement Act of 2008, was released after several months of negotiations in the conference committee to reconcile differences between the House and Senate versions of the bill. The bill passed the House of Representatives and the Senate on July 30, 2008 (424-1) and July 31, 2008 (89-3), respectively. On August 14, 2008, President Bush signed the bill into law as P.L. 110-314. CPSC Chairman Nord and Commissioner Moore each expressed approval of the final legislation, with Chairman Nord expressing a desire for Congress to appropriate further funding to carry out the new mandates of the legislation.40

Children’s Product Safety Lead Content and Measurement (§101) Under CPSIA § 101, 15 U.S.C. § 1 278a, in products for children aged 12 and younger, the permissible lead level will be phased in over three years at 600 parts per million (ppm) within 180 days of enactment, 300ppm after one year, and 100ppm after three years. If 100ppm is not technically feasible, the CPSC must set the lowest level that is technologically feasible. After promulgation of either the 100ppm level or the lowest level technologically feasible, the CPSC is required to periodically review and lower the limit at least every five years. There are exceptions for certain materials or products and inaccessible component parts. If the CPSC determines that it is not technologically feasible for certain electronic devices to comply with the lead standard, it must also issue requirements to minimize

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exposure or accessibility to lead in those devices. The permissible lead level in paint is reduced to 0.009 percent (90 ppm) from 0.06 percent (600ppm), subject to subsequent periodic review and reduction to the lowest lead level technologically feasible. A CPSC Office of General Counsel memorandum clarifies that inventory of noncompliant products may not be sold after this provision‘s effective date of February 10, 2009.41 Although the CPSIA does not expressly ban such sale or distribution, the Office of General Counsel concludes that a reading of the CPSIA as a whole indicates such an interpretation.

Third-Party Testing and Certification of Children’s Products (§102) Section 102 of the CPSIA amends CPSA §14 (codified at 15 U.S.C. §2063) to require manufacturer certification of safety testing by accredited third-party laboratories of products designed or intended primarily for children aged 12 and younger. The CPSC must issue accreditation requirements for such laboratories and maintain a list of accredited laboratories; deadlines for the publication of such requirements differ according to the type of product being tested by the laboratory. Specific deadlines for publication of accreditation requirements after CPSIA enactment are established for the testing of lead paint (30 days of enactment),42 cribs and pacifiers (60 days of enactment), small parts (90 days of enactment), children‘s metal jewelry (120 days of enactment), and baby bouncers/walkers/jumpers (210 days of enactment). Accreditation requirements related to the testing of other children‘s products must be published as early as practicable, but no later than 10 months after CPSIA enactment or, for safety rules established or revised one year or more after CPSIA enactment, not later than 90 days before such rules take effect. For three years after enactment, CPSC proceedings for promulgating accreditation requirements are exempt from requirements of the Regulatory Flexibility Act and the rulemaking requirements of the Administrative Procedure Act. Upon request, proprietary labs insulated from the influence of the manufacturer/private labeler-owner may be accredited by the CPSC and permitted to test products if they provide equal or greater protection than available third-party labs. CPSC personnel are authorized to enter and inspect any accredited proprietary lab (CPSIA §215(a)). The CPSC is required to establish requirements for the periodic audit of third-party testing labs as a condition of continuing accreditation. The CPSC is authorized to revoke accreditation if necessary after an investigation finding that a lab failed to follow a requirement established by the CPSC or is unduly influenced by a manufacturer or government entity. It is unclear which preemption provisions in the CPSA, as amended by the CPSIA, if any, apply to this provision concerning third-party testing and certification. There are two preemption provisions that are possible applicable. The new provision added by CPSIA § 106(h), discussed below, exempts from federal preemption any state/local toy safety standards in effect on the date of CPSIA enactment, if the state/locality applies for exemption within 90 days of CPSIA enactment. Under this provision, states/localities may also apply for exemption of future proposed state/local toy safety standards. If the preemption provisions of CPSIA § 106 do not apply, the general preemption provisions under CPSA §26, which predate the CPSIA, might apply to the testing and certification provisions, which are amendments to the CPSA. These provisions permit states/localities to apply for exemption of a proposed safety standard or regulation which is designed to protect against a risk of injury associated with a consumer product subject to a consumer product safety standard under the CPSA. These provisions do not permit exemption of existing state/local product safety

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standards or regulations which prescribe requirements for the performance, composition, contents, design, finish, construction, packaging, or labeling and which are designed to deal with the same risk of injury as the federal standard, unless such requirements are identical to the those of the federal standard. It is unclear whether testing and certification requirements may be considered consumer product safety standards for the purpose of these preemption provisions.

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Tracking Labels for Children’s Products (§103) Effective one year after the CPSIA enactment, CPSIA §103 amends CPSA §14 (codified at 15 U.S.C. §2063) to require a manufacturer to place tracking labels on children‘s products and packaging, to the extent practicable, containing information (manufacturer, production date, and production batch/run of the product) enabling the retailer and ultimate purchaser to identify recalled products and enhancing the ability of the manufacturer to track unsafe products to their precise sources. Advertisements, labels, and packaging for a consumer product will be prohibited from referring to a mandatory consumer product safety rule or a voluntary standard unless the product complies with such rule or standard. Standards and Registration Forms for Durable Nursery Products (§104) Under CPSIA §104 (15 U.S.C. §2056a), the Danny Keysar Child Product Safety Notification Act, the CPSC, in consultation with stakeholders and product engineers/experts, must establish mandatory safety standards for a variety of durable nursery products for use by children under five years of age. Such products include cribs, toddler beds, high chairs and booster/hook-on chairs, gates and other enclosures, bath seats, play yards, stationary activity centers, infant carriers, strollers walkers, swings, bassinets, and cradles. The CPSC is required to periodically review and revise such standards to ensure the highest level of safety feasible for such products. Any commercial users (including child care centers and hotels/motels) are prohibited from manufacturing, selling, reselling, leasing, or providing for use any cribs that do not comply with these mandatory safety standards. Manufacturers of durable children‘s products must provide consumers with registration forms in a required format/mode facilitating registration and to maintain databases of registrants to be used to notify such consumers in the event of a product recall or safety alert. The CPSC is required to study whether registration forms should also be mandatory for other children‘s products and to periodically review and assess the effectiveness of alternative recall notification technologies. Labeling for Certain Toy and Game Advertising (§105) CPSIA §105 amends FHSA §24 (codified at 15 U. S.C. § 1278), requiring choking hazard labelling for certain toys and games, to require similar cautionary statements on or immediately adjacent to advertising that provides a direct means of purchase, including advertising on Internet websites, in catalogues, or other advertising materials. This requirement applies to advertisements by a retailer, manufacturer, importer, distributor, or private labeler. A manufacturer, importer, distributor, or private labeler is required to inform a retailer to whom it provides a product of any cautionary statement requirement applicable to that product. A retailer is not liable for violating the advertising requirement if it requested applicable cautionary statement information from a manufacturer, importer, distributor, or private labeler who failed to provide such information or provided false information. The

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statement must be displayed in a clear and conspicuous manner and in the language primarily used in the advertisement, website, or catalogue. Certain format and display requirements apply. The advertising requirements take effect for internet websites 120 days after enactment and for catalogues 180 days after enactment; the CPSC may grant a grace period for catalogues. The distribution of a noncompliant advertisement is a prohibited act under the CPSA.

Adoption of a Mandatory Toy Safety Standard (§106) CPSIA § 106 (15 U.S.C. §2056b) provides that ASTM International Standard F963-07, Consumer Safety Specification for Toy Safety, the voluntary toy safety standard promulgated by the American Society for Testing and Materials (ASTM), an independent standard-setting organization, shall be deemed a mandatory interim consumer product safety standard, pending review, in the form current on the date of enactment, with certain exceptions. The exceptions are §4.2 and Annex 4 or any provision that restates or incorporates an existing mandatory standard or ban promulgated by the CPSC. Within two years of CPSIA enactment, the CPSC must promulgate this interim standard, with revisions to further enhance toy safety, by a final rule after reviewing it. The CPSC is required to periodically review and revise the rule to ensure the highest level of toy safety. ASTM is required to notify the CPSC if it proposes revisions to this standard. The proposed revision will be incorporated into the CPSC rule and the revised standard will then be considered a CPSC rule effective 180 days after the ASTM notification was received, unless the CPSC notifies ASTM within 90 days of receiving such notification that it has determined that the proposed revision does not improve the safety of the products covered by the standard. The existing standard, without the proposed revision, will then continue to be the CPSC rule. CPSIA § 106(h) provides that nothing in the federal toy standard or in the CPSA statute concerning preemption shall prevent a state or local safety requirement for toys or children‘s products from remaining in effect if it was in effect on the day before the date of CPSIA enactment and the state or locality has filed the requirement with the CPSC within 90 days after CPSIA enactment. Upon such application, the CPSC shall consider a proposed state or local safety standard and shall grant the exemption if the state or local standard provides a significantly higher degree of protection than the federal standard and does not unduly burden interstate commerce. Study of Disparities in Injury/Death Rates of Minority Children (§107) Section 107 of the CPSIA requires the U.S. Government Accountability Office (GAO), within 90 days of the date of enactment of this legislation, to initiate a study, by itself or an independent contractor, assessing racial/ethnic disparities in the risks and incidence of preventable injuries and deaths related to suffocation, poisonings, and drownings, including those linked to the use of cribs, mattresses, swimming pools, toys, and other products intended for use by children. Minority populations in the study include Black, Hispanic, American Indian, Alaskan Native, Native Hawaiian, and Asian/Pacific Islander children in the United States. GAO shall consult with the CPSC as necessary. GAO is required to report its findings to the relevant congressional committees not later than one year after the date of enactment of this legislation, including recommendations for minimizing risks of preventable

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deaths and injuries among minority children, for awareness and prevention campaigns targeting minority populations, and for education initiatives to reduce current statistical disparities.

Ban on Specified Phthalates and Certain Alternatives in Certain Children’s Products and Child Care Articles (§108) Beginning 180 days after enactment of the CPSIA, §108 of the CPSIA (15 U.S.C. §2057c) permanently bans the three phthalates (chemical plasticizers used in toys and other children‘s products) whose toxicity is not disputed and temporarily bans three other phthalates, pending a review by a Chronic Hazard Advisory Panel (CHAP).43 It prohibits children‘s toys or child care articles that contain more than 0.1% di-(2 ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). The sale of children‘s toys or child care articles containing concentrations of more than 0.1% of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP) are prohibited on an interim basis until a review by a CHAP. After the CPSC receives the report from the CHAP, it must determine, by rule, whether to continue the interim ban; evaluate the CHAP findings and recommendations; and declare any children‘s product containing phthalates to be a banned hazardous product if it determines this necessary to protect children‘s health. This provision clarifies that it does not preempt state laws regulating the use of phthalate alternatives not specifically regulated in a standard under the CPSA. ―Children‘s toy‖ is defined as a product designed or intended for a use by a child 12 years of age or younger, and ―child care article‖ is defined as a product designed or intended for a child three years of age or younger to facilitate sleep, feeding, sucking, or teething.

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Strengthening Commission Administration and Resources Reauthorization Years and Funding (§201) Section 201(a) of the CPSIA amends CPSA §32(a) to authorize progressively increasing appropriations annually. Out of these amounts, funding shall be made available for travel, subsistence, and related expenses incurred for official duties of the Commissioners and employees in attending meetings. This travel money is to be used in lieu of accepting funds from outside sources, as further discussed below. In addition to requiring the CPSC to report on personnel development efforts, CPSIA §201(b) requires the CPSC to submit a report on funding allocation plans to the appropriate congressional committees, not later than 180 days after enactment of the act. This report must include the efforts of the CPSC to reach and educate second-hand retailers of consumer products, particularly with regard to recalls of durable nursery products. Such education efforts shall include the development of educational materials for distribution not later than one year after enactment of the CPSIA.

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Table 1. Authorized Total Appropriations and Travel Component for CPSC, FY2010-FY2014 Fiscal Year FY2010 FY2011 FY2012 FY2013 FY2014

Authorized Amount $118,200,000 $115,640,000 $123,994,000 $131,783,000 $136,409,000

Authorized Travel Amount $1,200,000 $1,248,000 $1,297,000 $1,350,000 $1,403,000

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Source: Section 201(a) of the CPSIA.

Full Commission Funding and Interim Quorum (§202) Under CPSA §4(d) (codified at 15 U.S.C. §2053), three commissioners of the five constitute a quorum; two can constitute a quorum if necessary due to a vacancy on the Commission, but only for six months after the vacancy occurs. Title III of Pubic Law 10238944 limited funding to three Commissioners from FY1993 and thereafter. This limitation impeded the Commission‘s ability to meet the quorum necessary to take certain actions. The limitation dated back to the mid-1980s when Congress was contemplating restructuring the CPSC as a three-member commission or replacing the Commission with a single administrator, which had been the Senate‘s original proposed scheme in its 1972 version of the legislation that ultimately became the CPSA.45 During consideration of the 1990 reauthorization of the CPSC, the Senate bill would have permanently reduced the CPSC to three members with a quorum of two, but ultimately the authorization of a temporary quorum of two was adopted.46 If a vacancy lasted longer than six months, as had been the case recently, the Commission could not establish mandatory standards or engage in other rulemaking or procedures, including taking certain enforcement actions requiring decisions by the Commissioners, mandatory recalls, and corrective actions. The quorum requirements were temporarily superseded by §2204 of P.L. 110-53,47 permitting two Commissioners, if they were not affiliated with the same political party, to constitute a quorum for six months beginning on the date of enactment of the act (August 3, 2007); this authority expired on February 3, 2008. Section 202(a) of the CPSIA provides that, if they are not affiliated with the same political party, two members shall constitute a quorum for one year beginning on the date of enactment of the act. CPSIA §202(b) repeals the funding limitation, effective one year after enactment of the act, in order to restore the CPSC to its full five-member size and prevent the recent quorum problems. Personnel (§202(c)) Section 202(c) of the CPSIA (15 U.S.C. §2053 note) requires the CPSC to increase the number of fulltime Commission employees to at least 500 by October 1, 2013, subject to the availability of appropriations and, out of this number, requires the addition of an unspecified number of personnel to be assigned to U.S. ports of entry or to inspect overseas production facilities.48 Under CPSIA §201(b), requiring a CPSC report to the appropriate congressional committees on funding allocation plans, the CPSC must include the number of full-time

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investigators and other full-time equivalents the CPSC intends to employ. This report must also include CPSC efforts to develop standards for training product safety inspectors and technical staff and CPSC efforts and policies encouraging scientific staff to seek appropriate publishing opportunities in peer-reviewed journals and other media.

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Reports to Congress (§203) Section 3003 of P.L. 104-66 (the Federal Reports Elimination and Sunset Act of 1995, codified as amended at 31 U.S.C. § 1113 note) provided that, with certain exceptions, reports required to be submitted to Congress, as listed in H. Doc. 103-7, were terminated. Section 203 of the CPSIA (15 U.S.C. §2076 note) requires that after the date of enactment of the CPSIA, notwithstanding any rule, regulation or order to the contrary, the CPSC must comply with the requirement of CPSA §27(k) (codified at 15 U.S.C. §2076(k)) that it submit copies to Congress of budget recommendations, legislative recommendations and comments, and testimony that it submits to the President or the Office of Management and Budget. These copies are expressly exempted from the reporting limitations of P.L. 10466. Expedited Rulemaking Procedures (§204) Critics alleged that the prior rulemaking procedures under CPSA §9 and other acts under the CPSC‘ s jurisdiction, the FHSA and the FFA, were unnecessarily onerous, requiring procedural steps beyond those required by the Administrative Procedures Act. Section 204 of the CPSIA streamlines the rulemaking procedures under CPSA §9 and similar provisions under the FHSA and FFA by eliminating the requirement for an advanced notice of proposed rulemaking (ANPR), a step not required by the Administrative Procedure Act (APA). This ANPR was required to include an invitation for persons to submit existing standards as proposed consumer product safety standards or statements of intention to develop or modify a voluntary standard, as well as commentary. Amendments conforming to the elimination of this requirement are also made. CPSIA §204 clarifies that the elimination of the ANPR requirement does not preclude a person from submitting all or part of an existing standard as a proposed consumer product safety standard. The FHSA is also amended to eliminate the required use of additional rulemaking procedures under the Food, Drug, and Cosmetic Act. Technical amendments to the FHSA replace references to the Secretary of Health, Education and Welfare (HEW) [now Health and Human Services (HHS)], which remained from the original authority of the Secretary of HEW and the Food and Drug Administration over the FHSA, with references to the CPSC. Technical amendments to the FFA replace references to the Secretary of Commerce and the Federal Trade Commission (FTC), which remained from their original authority over the FFA, with references to the CPSC. References to specific congressional committees in the rulemaking provisions of the FHSA and the FFA are changed to references to the ―appropriate congressional committees.‖ Inspector General Audits and Reports (§205) Section 205 of the CPSIA (15 U.S.C. §2076b) requires the Inspector General of the CPSC to:

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conduct reviews and audits to assess the CPSC‘s capital improvement efforts, including upgrades of its information technology system and the development of the new public safety database, and the adequacy of the accreditation and monitoring process for third-party testing laboratories; within one year of enactment of the CPSIA, conduct a review of (1) CPSC employee complaints concerning failures of other employees to properly enforce the rules and regulations of the laws enforced by the CPSC or otherwise carry out responsibilities if such failures raise issues of conflicts of interest, ethical violations, or the absence of good faith, and (2) CPSC actions to address such complaints and failures; submit annual reports with respect to the findings and recommendations resulting from these audits and reviews to the appropriate congressional committees beginning in FY2010; transmit a report to the appropriate congressional committees within 60 days of enactment of the CPSIA on the activities of the Inspector General, any barriers preventing robust oversight of the CPSC by the Inspector General, and any additional resources and authority needed for effective oversight.

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This provision further requires the CPSC, within thirty days of enactment of the CPSIA, to establish and maintain (1) a direct link from the homepage of the CPSC to the webpage of its Inspector General, and (2) a mechanism on the Inspector General‘s website by which individuals may anonymously report cases of waste, fraud, or abuse with respect to the CPSC.49

Ban on Industry-Sponsored Travel (§206) The CPSC has been criticized for the ethical issues raised by its practice of accepting funds from industry groups to cover travel to meetings and conferences.50 As noted above, CPSIA §201(a) amends the authorization of appropriations in the CPSA to provide funds annually from FY2010 to FY2014 for travel to attend meetings and similar functions in furtherance of the official duties of the Commissioners and employees. These funds are to be used in lieu of accepting payment or reimbursement for such expenses from any person seeking action from, doing business with, or conducting activities regulated by the CPSC or whose interests may be substantially affected by the performance (or nonperformance) of a Commissioner‘s or employee‘s official duties. CPSC Chair Nord supported these amendments.51 In the past, she had defended the practice of accepting such paid travel to seminars and conferences as enabling industry education and outreach concerning safety standards and CPSC procedures that otherwise would not have been possible under the previous CPSC budgets. Section 206 of the CPSIA adds a new §39 to the CPSA (15 U.S.C. §2086) with parallel language prohibiting Commissioners and employees of the CPSC from accepting travel and related expenses for any meeting or similar function related to official duties from a person seeking action from, doing business with, or conducting activities regulated by the CPSC and whose interests may be substantially affected by the performance of the Commissioner‘s or employee‘s official duties.

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Information Sharing with Other Government Agencies (§207) Section 207 of the CPSIA amends CPSA §29 (codified at 15 U.S.C. §2078) by authorizing the CPSC to share information obtained under the CPSA with federal, state, local, or foreign government agencies, notwithstanding the public disclosure requirements of the CPSA, where there is a prior agreement or other written certification that such information will be maintained in confidence and used only for law enforcement or consumer protection purposes and certain other conditions apply. The CPSC may terminate such agreements if it determines that the other agency has failed to abide by the conditions of the agreement. The CPSC shall not be required to disclose information it obtained from a foreign government agency or foreign source, if such information was provided on the condition of confidentiality, or through a CPSC reporting mechanism sponsored in part by foreign government agencies. However, nothing in this provision authorizes the CPSC to withhold information from Congress or prevents the CPSC from complying with a federal court order in an action by the United States or the CPSC. Foreign government agencies include multinational organizations comprising foreign states and vested with law enforcement or investigative authority in civil, criminal, and administrative matters. The CPSC must notify each state‘s health department of any CPSC mandatory recall or any voluntary recall of which it has been notified.

Employee Training Exchanges (§208) Section 208 of the CPSIA (15 U.S.C. §2053a) authorizes the CPSC to engage in employee exchanges with foreign government agencies so that officers and employees of the CPSC and the foreign government agencies may receive or provide training. There is no requirement for reimbursement or reciprocity; any reimbursement for expenses incurred by the CPSC shall be credited to the appropriations account from which such expenses were paid. An officer or employee of a foreign government agency who is employed by the CPSC as part of a training exchange shall be considered a federal employee during such employment only for the purposes of federal laws governing work injury compensation for federal employees, tort claims liability of the Federal Government, federal employee ethics and government corruption crimes, and any other law or regulation governing the conduct of federal employees. Repeal of CPSA §30(d) (§237) Section 237 of the CPSIA streamlines certain regulatory proceedings under the CPSA by repealing CPSA §30(d) (15 U. S.C. §2079). The FHSA, FFA, and PPPA existed at the time the CPSA was enacted in 1972 and separately provided for regulatory authority and proceedings. When the CPSA was enacted, it included a requirement in CPSA §30(d) that a product which could be regulated under the FHSA, FFA, or PPPA could only be regulated under the CPSA if the CPSC first issued a rule finding that it was in the public interest to regulate a product under the CPSA. Cost-Benefit Analysis under the PPPA (§233) A GAO report concerning the effectiveness of cost-benefit analyses by the CPSC found, inter alia, that the CPSC often conducted such analyses in considering a consumer safety standard, even when not legally required to do so.52 GAO noted that although the CPSA,

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FHSA, and FFA required cost-benefit analyses in order to promulgate a standard, the PPPA did not. Nevertheless, CPSC had conducted such analyses on several occasions in considering special packaging standards under the PPPA. Apparently in response to such commentary, CPSIA §233 amends §3 of the PPPA, regarding establishment of special packaging standards, by clarifying that nothing in the act shall be construed to require a cost-benefit analysis of a potential safety standard under the act in order to promulgate such standard.

Enhanced Enforcement and Cooperation Prohibition on Stockpiling (§213) CPSA §9(g) (codified at 15 U.S.C. §2058(g)) authorizes the CPSC to prohibit manufacturers from stockpiling products prior to the effective date of a consumer product safety rule; that is, from manufacturing the product at a higher-than-normal rate between the date that a rule is promulgated and the date it takes effect, in an attempt to circumvent the rule. This authority only applied to safety standards and rules promulgated under the CPSA and not to standards or rules promulgated under other statutes under CPSC jurisdiction such as the FHSA or FFA. Section 213 of the CPSIA amends this provision so that it authorizes the prohibition of stockpiling of products prior to the effective date of an applicable rule under any statute enforced by the CPSC.

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Prohibited Acts (§216) Section 216 of the CPSIA increases the scope of acts prohibited under CPSA §19 (codified at 15 U.S.C. §2068) by adding new prohibited acts and by expanding the application of existing prohibited acts. The additional or amended prohibitions include the sale, manufacture, distribution, or importation of a product regulated by the CPSC that does not comply with an applicable consumer product safety rule under the CPSA or any similar rule, regulations, standard or ban under any other act enforced by the CPSC [prohibition extends to products regulated under other acts such as the FHSA]; the sale, manufacture, distribution, or importation of a product that is the subject of a voluntary corrective action and recall of which either the CPSC has notified the public or the seller, distributor, or manufacturer knew or should have known; the sale, manufacture, distribution, or importation of a product that is the subject of a CPSC order for a recall or corrective action or a court order declaring an imminent hazard; the sale, manufacture, distribution, or importation of a banned hazardous substance, meaning a children‘s article or toy which is a hazardous substance or which contains a hazardous substance accessible to a child; failure to furnish a required compliance certification or issuance of a false compliance certification under any act enforced by the CPSC, including failure to comply with requirements for testing, certification, and tracking labels for certain children‘s products;

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Margaret Mikyung Lee sale, importation or distribution of a consumer product bearing a false safety compliance certification mark; misrepresentation to CPSC officers/employees of the scope of products subject to recall/corrective action or a material misrepresentation in a CPSC investigation; undue influence of a third-party laboratory with respect to testing a product for compliance with safety standards under any act enforced by the CPSC; the export for sale of any consumer product or substance regulated by the CPSC (except for the re-export of a product denied importation into the United States) that is the subject of a voluntary corrective action, a CPSC order for a recall or corrective action, a court order declaring an imminent hazard, or that is a banned hazardous substance (meaning a children‘s article or toy which is a hazardous substance or which contains a hazardous substance accessible to a child); and violation of a CPSC order prohibiting an export under new subsection 18(c) of the CPSA (see below).

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In particular, the prohibition on the sale of products that are the subject of a mandatory or voluntary recall closes a gap in the prior law, which permitted the continued sale of inventory that is the subject of a recall. The export restrictions are also new, since previously there were no restrictions on exports of recalled products or banned hazardous substances, beyond a requirement to notify the CPSC and the receiving country that an export did not comply with a U.S. safety standard or was a banned hazardous substance. In general, these CPSIA amendments prohibit violations of the new requirements under the CPSIA. Section 216 also makes a conforming amendment to CPSA § 17(a)(2) to prohibit the importation of a consumer product that does not have a required certificate or label or has a false certificate.

Penalties (§217) Section 217 of the CPSIA increases the civil and criminal penalties under the CPSA, the FHSA, and the FFA. The maximum civil penalty increases from $8,000 to $100,000 for each violation and from $1.825 million to $15,000,000 for a related series of violations.53 Not later than December 1, 2011, and every five years thereafter, the maximum civil penalty must be adjusted for inflation. Several factors must be considered in determining civil penalties under the CPSA, the FHSA, and the FFA, including the nature, circumstances, extent and gravity of the violation, in addition to those currently enumerated in these acts. The CPSC must consider mitigation of undue adverse economic impacts on small businesses. Not later than one year after enactment, the CPSC must promulgate regulations providing its interpretation of the criteria to be considered in imposing civil penalties. The amendments to the civil penalties take effect on the earlier of the date on which the final criteria regulations are issued or the date one year after enactment. The criminal penalties increase to a maximum of five years imprisonment, a fine pursuant to 18 U. S.C. §3571 (establishing the maximum monetary fines), or both, for knowing and willful violations of the CPSA and the FFA and for violations with intent to defraud or mislead or repeat offenses under the FHSA. Penalties may also include forfeiture of assets associated with the criminal violation of the CPSA or any other statutes enforced by the CPSC. Section 217 of the CPSIA also removes the requirement in the CPSA that directors,

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officers, and agents have knowledge of a notice of noncompliance in order to be subject to criminal penalties separate from those imposed on their corporation.

Enforcement by State Attorneys General (§218) Prior to its amendment by the CPSIA, CPSA §24 (codified at 15 U.S.C. §2073), entitled ―Private Enforcement of Product Safety Rules and of Section 15 Orders,‖ provided for a cause of action that could be brought by ―[a]ny interested person (including any individual or nonprofit, business, or other entity)‖ in a federal district court to enforce a consumer safety rule or corrective action order by an injunction. Despite the section heading and the absence of an express reference to state attorneys general, this provision apparently had been understood to authorize enforcement actions by state attorneys general, limited to injunctive relief. The FHSA and FFA were amended in 1990 to expressly authorize state attorneys general to enforce consumer safety rules under those statutes by obtaining injunctive relief. This amendment was justified and premised on the existence of similar authority under the CPSA.54 However, it appears that this authority was rarely, if ever, used by state attorneys general, as there apparently was no reported case precedent for such an action; it appears that state attorneys general more typically took action under state consumer protections laws, while urging the CPSC to take action under federal laws. Section 218 of the CPSIA amends CPSA §24 (codified at 15 U.S.C. §2073) by renaming the section ―Additional Enforcement of Product Safety Rules and of Section 15 Orders‖ and adding a new subsection expressly authorizing state attorneys general (or other authorized state officer) to bring an action in any federal district court where the defendant is found or transacts business to obtain injunctive relief against certain prohibited acts under the CPSA. 55 Such actions are subject to certain conditions, similar to the procedures in CPSA §24 and other similar consumer protection statutes.56 A state must give 30-day written notice to the CPSC before filing a civil action, except when a state has determined that immediate action is necessary to protect its residents from a substantial product hazard as defined in CPSA § 15(a). In such cases, a state may file a suit immediately after notifying the CPSC of such determination. The CPSC may intervene in such civil actions to be heard on all matters arising from such actions and to appeal decisions in such actions. A state cannot bring a civil action where the same alleged violation is the subject of a pending criminal or civil action brought by the Federal Government, aside from suits alleging a violation of the ban on selling, manufacturing, distributing, or importing a product that is noncompliant, subject to a mandatory/voluntary corrective action, or a children‘s product that is a banned hazardous substance. Any outside private counsel retained to assist in such state civil actions is prohibited from sharing with parties in other private civil actions arising out of the same facts any information that is subject to a litigation privilege and was obtained during discovery in the state attorney general‘s action, or from otherwise using such information in the other private civil actions. In addition to the new state civil enforcement authority in the CPSA, CPSIA §217 adds a conforming provision to the PPPA authorizing state civil enforcement of a standard or rule under that act, subject to the procedural requirements of the CPSA. Nothing in the new CPSA authority for state civil enforcement actions or in the similar provisions in the FHSA, FFA, and PPPA shall be construed as preventing a state attorney general or other state officer from exercising his/her powers under the state laws or as

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prohibiting him/her from proceeding in state or federal court on the basis of an alleged violation of any civil or criminal state statute.

Whistleblower Protections (§219) Notwithstanding criticism of whistleblower protection by CPSC Acting Chair Nord,57 CPSIA §219 adds a new §40 to the CPSA (15 U.S.C. §2087) to provide whistleblower protections for private sector employees. Such protections are not provided for federal, state, and local government agency employees; the compromise reached in the conference agreement eliminated proposed coverage of government employees.58 New CPSA §40 establishes a remedy for an employee of a manufacturer, private labeler, distributor, or retailer, who believes that he/she has been subjected to adverse employment actions in retaliation for (1) providing information to the employer, Federal Government, or a state attorney general relating to a violation of any laws, rules, orders, standards, or bans enforced by the CPSC; (2) testifying in or otherwise cooperating with a proceeding concerning such violation; or (3) objecting to or refusing to participate in any activity or policy that the employee reasonably believed would be a violation of laws, rules, orders, standards, or bans enforced by the CPSC. The remedy is not available to an employee who, of his/her own volition, intentionally caused a violation of any laws, rules, orders, standards, or bans enforced by the CPSC. The employee can file a complaint with the Secretary of Labor within 180 days of the alleged retaliatory action. The Secretary must then notify the person named as responsible for the retaliation and give him/her an opportunity to respond to the allegations. The Secretary must dismiss a complaint unless the complainant shows that the whistleblowing activities were a contributing factor in the adverse employment action. If the complainant shows this, but the employer shows, by clear and convincing evidence, that it would have taken the same unfavorable action in the absence of the whistleblowing activities, then the Secretary cannot further investigate the complaint. Otherwise, within 60 days of the complaint filing, the Secretary of Labor must conduct an investigation to determine whether there is reasonable cause to believe the complaint has merit and issue findings in writing, with a preliminary relief order where merited. Within 30 days of notification of the findings, the defendant can object and request a hearing; otherwise, the order becomes final and not subject to judicial review. The new provision establishes the standards for burden of proof and evidence. Within 120 days of the hearing, the Secretary of Labor must issue a final relief order or denial. If the Secretary determines that retaliation has occurred, the Secretary shall order the person responsible for the retaliation to take affirmative steps to redress the retaliation; to reinstate the complainant to his or her former position with compensation, including back pay, and other terms, conditions, and privileges of his/her employment; and to provide compensatory damages. At the request of the complainant, the Secretary can also assess a sum of the aggregate amount of all costs and fees reasonably incurred by the complainant for bringing the complaint. If the Secretary of Labor finds that the complaint was frivolous or in bad faith, the employer may be awarded attorneys‘ fees to be paid by the complainant. If the Secretary has not issued a final decision within 210 days of the complaint filing or within 90 days of a written determination, the complainant can bring an action for de novo review in a federal district court with jurisdiction, without regard to the amount in controversy. The same burdens of proof for the administrative hearing apply to the judicial review. The court has

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jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages (including reinstatement with the same seniority status, back pay with interest, and special damages such as reasonable attorney‘s fees, expert witness fees, and litigation costs). Except where a person has already sued in federal court as described in the above paragraph, any person adversely affected by a final administrative order can appeal to the federal appellate court having jurisdiction in the area where the violation allegedly occurred or in which the complainant resided when the violation allegedly occurred. Such appeal does not stay the relief order unless so ordered by the court. If such direct appeal is not made, the administrative order cannot be judicially reviewed in other proceedings. The Secretary of Labor can file a civil action in a federal district court for the District of Columbia or where the violation occurred to enforce an order against a person who has failed to comply. The court can grant all appropriate relief, including, but not limited to, injunctive relief and compensatory damages. Also, a person for whom an order of relief was granted may bring an action in a federal district court to require compliance, without regard to the amount in controversy or diversity of citizenship of the parties. The court may award court costs and fees as appropriate. Any nondiscretionary duty imposed by this section is enforceable in a mandamus proceeding under 28 U.S.C. § 1361.

Federal Law Preemption (§231) Certain provisions of the CPSA, FHSA, FFA, and PPPA establish the extent to which those acts preempt, limit, or otherwise affect any other federal, state, or local law or affect any cause of action under state or local law. Section 231(a) of the CPSIA (15 U.S.C. §2051 note) clarifies that these provisions may not be expanded, contracted in scope, limited, modified, interpreted, or extended in application in any rule, regulation, preamble, statement of policy, etc., of the CPSC. The CPSC may not construe the statutory preemption provisions as preempting any cause of action under state or local common law or state statutes regarding damage claims. The purpose of these provisions apparently is to prevent the CPSC from issuing directives or statements purporting to preempt state common-law tort causes of action in the preambles to regulations that it promulgates, such as it did with the ―Standard for the Flammability (Open Flame) of Mattress Sets.‖59 Pursuant to Executive Order 12988 of February 5, 1996,60 the Federal Register notice issuing the final rule for the mattress standard explained the Commission‘s understanding of the preemptive effect of the Flammable Fabrics Act. Citing congressional intent evidenced in the legislative history and statutory text, the ―Commission intends and expects that the new mattress flammability standard will preempt inconsistent state standards and requirements, whether in the form of positive enactments or court created requirements.‖ Such preemption directives apparently have become more common in recent years, causing concern among opponents61 and observations by some legal scholars that these directives have become a ―backdoor‖ method of expanding federal objectives.62 In the absence of express congressional, statutory direction with regard to preemption, agencies may interpret the preemptive intent through such directives and regulations.63 Commentators have noted that the federal courts are divided on the issue of the level of deference the courts should give to such agency preemption directives.64

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Section 231(b) of the CPSIA clarifies that nothing in the CPSIA or the FHSA shall be interpreted as preempting or otherwise affecting state warning requirements established under state laws in effect prior to August 31, 2003. As discussed on page 11 of this report, the CPSIA includes certain preemption provisions regarding state toy standards. The CPSIA does not provide for federal preemption of state third-party testing and certification requirements.

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Enhanced Inspection, Public Notice, and Recall Public Disclosure of Information (§211) The CPSIA reduces the previous protections for disclosure of product information by amending CPSA §6 (codified at 15 U.S.C. §2055). This section provides for certain safeguards for the public disclosure of information on products that are identified as specific products of named manufacturers. Proprietary/trade secret information may not be disclosed, and information protected from disclosure by the Freedom of Information Act (FOIA) may not be disclosed. The manufacturer must be notified and given the opportunity to review information to be disclosed with regard to confidentiality and accuracy within a minimum period of time prior to disclosure, unless the CPSC finds that public health and safety require a lesser period of notice and publishes this finding. If the CPSC disagrees with the manufacturer and decides to disclose allegedly confidential or inaccurate information over the objections of the manufacturer, the manufacturer may sue in federal district court to enjoin disclosure. Certain types of information disclosure are exempt from these safeguards, including information regarding an imminently hazardous product, a violation of the CPSA, a rulemaking proceeding, an adjudicatory proceeding, or other proceeding under the CPSA. Consumer advocates and retailer critics of this provision prior to amendments made by the CPSIA asserted that these safeguards unnecessarily hindered the disclosure of safety and recall information, while industry advocates sought stronger protections with regard to substantiation and disclosure of information on product categories with problems that are not common to all manufacturers.65 Section 211 of the CPSIA reduces prior disclosure protections in several ways: A manufacturer/private labeler must respond within 15 days after the CPSC notifies it of the opportunity to mark as confidential information that could permit the public to identify it as the manufacturer/labeler of a product. Although the CPSA previously did not specify a time within which the manufacturer/labeler must respond, CPSC regulations concerning disclosures under the Freedom of Information Act (16 C.F.R. § 1015.18) require a response in five working days to a notice concerning information previously submitted to the CPSC by the manufacturer/labeler. These regulations also require that a response must accompany information submitted after a CPSC notice of the opportunity to request confidentiality (the submission may indicate a final confidentiality response within 10 working days of the new submission). The amendment reduces from 30 to 15 days before disclosure the time within which the CPSC must notify a manufacturer/labeler of an intended disclosure and provide

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the opportunity to comment on accuracy, and from 10 to five days the time within which the CPSC must notify a manufacturer/labeler that it will still disclose information claimed to be inaccurate based on a CPSC determination that the disclosure is accurate and fair. The CPSC is no longer required to publish in the Federal Register a finding that public health and safety require a lesser period of notice to the manufacturer, as it was before the CPSIA; it may publish this in any manner. Exemption of certain information from the disclosure protections is expanded to include violations of any rule or law enforced by the CPSC, not just the CPSA, and information for which the CPSC publishes a finding that public health and safety requires disclosure with a lesser period of notice and comment on accuracy than normally required. The CPSC is authorized to file a request for expedited consideration in a civil action in the federal district court for the District of Columbia to enjoin the disclosure of allegedly inaccurate information. However, such expedited consideration is not available in an action to enjoin disclosure on the grounds that it is protected or confidential under other laws. The Conference Report noted the Conferees‘ view that such expedited consideration should not delay action on other important matters before the court, such as Class A or B felonies.66

Establishment of a Public Consumer Product Safety Database (§212) Section 212 of the CPSIA adds a new section 6A to the CPSA (15 U.S.C. §2055a), establishing a publicly available, searchable, internet-accessible database on the safety of consumer products within two years of enactment. This provision resolves the issues some database opponents had with the database provision of the Senate-passed version of H.R. 4040. CPSC Acting Chair Nord previously had criticized the mandatory database under the Senate-passed version of H.R. 4040 (to be established without a study concerning feasibility, effectiveness, or other concerns) because it would have permitted publication of information and complaints received from consumers before the CPSC had the opportunity to vet the information for validity or accuracy and also because its implementation would have required 25 percent of the CPSC budget.67 However, proponents of the database pointed out that the National Highway Transportation Safety Administration already has such a database including automobile complaints reported by consumers that is publicly accessible through its website. The CPSC currently maintains the National Electronic Injury Surveillance System (NEISS),68 which is accessible to the public through the CPSC website.69 According to the CPSC website, ―NEISS injury data are gathered from the emergency departments of 100 hospitals selected as a probability sample of all 5,300+ U.S. hospitals with emergency departments. The system‘s foundation rests on emergency department surveillance data, but the system also has the flexibility to gather additional data at either the surveillance or the investigation level.‖70 The database mandated by the CPSIA is more comprehensive, drawing information from a variety of sources, including consumers. GAO has concluded that the current data systems, including NEISS, upon which the CPSC depends in prioritizing its regulatory and enforcement activities, are inadequate.71

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Under new CPSA §6A, the CPSC must transmit to Congress, within 180 days of the enactment of the CPSIA, a detailed plan for establishing and maintaining this database, including integration of the database into the CPSC‘s overall information technology improvement plans (the CPSC must expedite such plans). The plan shall include a detailed implementation schedule and plans for a public awareness campaign. Not later than 18 months after the plan is submitted, the CPSC must establish the database. The database shall include

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reports of harm (injuries, illness, death, or risks of injuries, illness, or death) relating to the use of consumer products, and other substances regulated by the CPSC, that are received by the CPSC from consumers, government agencies, health care professionals (such as physicians, hospitals and coroners), child service providers, and public safety entities (such as police and firefighters); information derived from a notice for a mandatory recall of a substantial product hazard or a notice for a voluntary corrective action; comments that a manufacturer/private labeler requests be included in the database to respond to information concerning its products; and any additional information the CPSC determines to be in the public interest. The new section establishes requirements for information to be included in reports submitted to the CPSC and for the mode of submission. The information on the database must be organized and categorized so that the information is sortable and retrievable by the date of submission, the name of the consumer product, the model name, the manufacturer‘s/private labeler‘s name, and other information fields that are in the public interest. The CPSC shall provide a clear and conspicuous notice that the CPSC does not guarantee the accuracy, completeness, or adequacy of the database contents. The name and address of a person submitting a report of harm for a product may not be disclosed by the CPSC, except that such information may be provided to the manufacturer/private labeler of the product with the express written consent of such person for the purpose of verifying the report. The safeguard restrictions of CPSA §6(a and b), briefly discussed in the previous section of this report, do not apply to the database disclosure of reports received from consumers, health-care providers, public safety entities, and government agencies. However, such safeguards apply to database information received via a report of a safety risk from a manufacturer, distributor or retailer under CPSA § 15(b)or any other mandatory or voluntary reporting program established between the CPSC and a manufacturer, retailer, or private labeler. Reports must be available on the database within 15 business days of receipt. Any information determined to be duplicative or inaccurate shall not be included when the report is added to the database or, if the report is already on the database, be removed or corrected within 7 business days of such determination. Within five business days of receipt, the CPSC is required to submit a report of harm to the manufacturer, who then has 10 business days to respond, to request the inclusion of its comments on the database, and to vet the report for and designate confidential or protected information. The CPSC must redact in the database any information it determines to be protected (trade secret or FOIA). If the CPSC determines that the designated information is not protected, it shall so notify the manufacturer or private labeler, who may bring an action seeking removal of such information from the database in

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the federal district court where it resides or has its principal place of business or in the District of Columbia. The CPSC is required to submit an annual report to the appropriate congressional committees on the operation of the database, including the cost and the number of reports and comments received, posted, and corrected or removed. Within two years of the establishment of the database, the GAO shall submit a report to the appropriate congressional committees containing an analysis of the general usefulness of the database, including an assessment of whether a broad range of the public uses the database and finds it useful, and recommendations for measures to increase use of the database by consumers and to ensure use by a broad range of the public. The Conference Report notes that, as part of general authorizations for FY2010 to FY2014, the Conferees authorized $25,000,000 to establish and maintain this database and to upgrade and integrate the CPSC information technology systems.72

Substantial Product Hazard Reporting Requirement (§214(a)(2)) Section 15 of the CPSA (15 U.S.C. §2064) requires manufacturers, distributors, and retailers to inform the CPSC when they learn that a product they distributed fails to comply with a consumer safety rule/standard, poses a substantial product hazard, or creates an unreasonable risk of injury or death. Prior to amendment by the CPSIA, the language of the provision did not include notification of noncompliance with rules or standards promulgated by the CPSC under other acts in its jurisdiction. Section 214(a)(2)(A) of the CPSIA expands the scope of CPSA §15(b) to require manufacturers, distributors, and retailers of any product or substance regulated by the CPSC, except for motor vehicle equipment, to notify the CPSC about products that do not comply with any rule, regulations, standard, or ban promulgated by the CPSC under any act. Section 214(a)(2)(C) of the CPSIA further amends CPSA § 15(b) to provide that a notification to the CPSC that a product fails to comply with a rule promulgated under the FHSA, FFA, or PPPA may not be used as the basis for criminal prosecution under the FHSA except for offenses requiring a showing of intent to defraud or mislead. The Conference Report clarifies that the Conferees included this provision ―to avoid an unjust result under a possible construction of section 5 that provides for strict liability for criminal enforcement without regard to any applicable requirement of knowledge, intent, or willfulness in such situations. . . . The Conferees do not intend for [this] to be used to shelter bad actors . . . but rather to ensure that there are no unintended impediments to the flow of information to the Commission.‖73 The House report, in discussing a similar provision in the House-passed version of H.R. 4040, clarifies that this applies when such notification constitutes the sole basis for criminal liability without a requirement of knowledge, willfulness, or intent.74 The CPSA criminal offenses require knowledge and willfulness. The FFA offenses generally require willfulness, although the FFA offense of failure to notify the CPSC of the export of a non-compliant product does not. Other acts administered and enforced by the CPSC do not provide for criminal penalties. Enhanced Public Notice of Substantial Product Hazards Section 214(a)(3) of the CPSIA improves public notification by amending CPSA § 15(c) (codified at 15 U.S.C. §2064(c)) to authorize the CPSC to order a manufacturer, distributor,

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or retailer of a product presenting a substantial product hazard to give public notice of such hazard via its website, notice to third-party internet sellers of the product, announcements in languages other than English, and announcements on radio and television where the CPSC determines that a substantial number of consumers may not be reached by other types of notice. This section further clarifies that the CPSC may require any notices under CPSA §15(c)(1) to be distributed in a language other than English, if it determines that doing so is necessary to adequately protect the public.

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Enhanced Authority for Corrective Action Plans and Recalls (§214) Section 214 of the CPSIA enhances the authority of the CPSC to order corrective action plans and recalls in several ways. Section 214(a)(1) of the CPSIA expands the definition of ―substantial product hazard‖ under CPSA §15(a)(1) (codified at 15 U.S.C. §2064(a)(1)) to include failure to comply with a rule, regulation, standard, or ban under any act enforced by the CPSC, as well as with an applicable consumer product safety rule under the CPSA. Section 214(a)(3 and 4) of the CPSIA amends CPSA §15(c and f) (codified at 15 U.S.C. §2064(c and f)) to enhance recall authority by expanding the scope of the hazard notification authority to include products against which an imminent hazard action has been filed in federal court as well as products determined by the CPSC to be a substantial hazard; authorizing the CPSC to order a manufacturer, distributor, or retailer to cease product distribution; notify other persons involved in transporting, storing, handling, or distributing the product to cease distribution; and to notify appropriate state and local health officials; requiring the CPSC to rescind any order concerning an allegedly imminently hazardous product if a federal district court determines that the product is not an imminently hazardous product; and clarifying that the requirement for a hearing prior to the issuance of an order to cease distribution and notify the public of a substantial product hazard does not apply to an order concerning a product against which the CPSC has filed an imminent hazard action. Section 214(b) amends CPSA §15(d) (codified at 15 U.S.C. §2064(d)) to strengthen CPSC authorities relating to corrective action plans by authorizing the CPSC to order public notice and corrective actions it determines are in the public interest and removes the ability of the manufacturer, distributor or retailer to choose which corrective action it may take; expanding and clarifying the scope of CPSC authority to include orders to conform with requirements of applicable rules, regulations, standards, or bans, not just applicable consumer product safety rules; requiring a CPSC corrective action order to include a requirement that the person to whom the order applies must submit a plan for such action to the CPSC for affirmative approval in writing, replacing the current passive requirement that the plan be satisfactory to the CPSC;

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authorizing the CPSC to order an amendment of a corrective action plan if it finds that the approved plan is ineffective or inappropriate and requiring it to consider whether a repair or replacement changes the intended functionality of the product; and authorizing the CPSC to revoke its approval of an action plan if it finds that a person has failed to comply substantially with its obligations under the action plan and prohibiting such person from distributing the product after receiving notice of such revocation.

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Requirements for Recall Notice Content (§214(c)) CPSIA §214(c) adds a new subsection 15(i) to the CPSA (15 U.S.C. §2064(i)) that requires the CPSC, within 180 days of enactment of the CPSIA, to establish guidelines for the information to be included in any recall/corrective action notice or imminent hazard notice that would aid consumers in identifying/understanding the specific product recalled, the nature of the associated hazard, and any available remedies. The provision further details the type of information required to be contained in a recall notice of a substantial product hazard. This information includes the model or stock keeping unit (SKU) number, common product names, photograph, description of action being taken, the number of product units for which such action is being taken, description of the substantial product hazard, identification of the manufacturers and distributors of the product, the dates the product was manufactured and sold, details of any deaths or injuries associated with the product, remedies available to the consumer, and any other information the CPSC deems necessary. Identification of Supply Chain (§215(b)) Section 215(b) of the CPSIA amends CPSA §16 (codified at 15 U.S.C. §2065), regarding inspection and recordkeeping, by adding a new subsection (c) to require importers, retailers or distributors of a consumer product or other product or substance regulated by the CPSC to identify the manufacturer upon the request of a CPSC officer or employee. Conversely, a manufacturer is similarly required to identify each retailer or distributor whom the manufacturer directly supplied with a consumer product and each subcontractor involved in the manufacture of such product or from whom the manufacturer obtained a component of such product. Financial Responsibility (§224) Section 224 of the CPSIA adds a new section 41 to the CPSA (15 U.S.C. §2088), requiring the CPSC, in consultation with U.S. Customs and Border Protection (CBP) and other relevant federal agencies, to identify any consumer product, or other product or substance regulated by any statute enforced by the CPSC, for which the cost of destruction would normally exceed the bond amounts under the customs laws and to recommend a bond sufficient to cover the costs of destroying the product. The new section further provides for a GAO study to determine the feasibility of mandating an escrow, proof of insurance, or other security to cover the costs of destruction of a domestically produced product or substance regulated under any act enforced by the CPSC or the costs of an effective recall of a domestic or imported product or substance regulated by the CPSC. The GAO must submit a report on the results of this study to the appropriate

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congressional committees within 180 days of enactment of the CPSIA, including an assessment of whether such requirements could be implemented and recommendations for implementation.

Annual Reporting Requirement (§209) Section 209 of the CPSIA amends the annual reporting requirement under CPSA §27(j) (codified at 15 U.S.C. §2076(j)) to include information on the number and summary of recall orders issued under CPSA §§12 and 15; a summary of voluntary actions taken by manufacturers in consultation with the CPSC and with public notice by the CPSC; and an assessment of such orders and actions. Additionally, within one year of the date of enactment of the CPSIA, the annual report shall include progress reports and incident updates with respect to corrective action plans ordered under CPSA § 15(d); injury and death statistics for substantial product hazards under CPSA § 15(c); and the number and type of communications from consumers to the CPSC for each product for which the CPSC orders corrective action. Inspection of Certified Proprietary Laboratories (§215(a)) Section 215(a) of the CPSIA amends CPSA §2065(a) (codified at 15 U.S.C. §2065(a)) to authorize CPSC officers and employees to enter and inspect certified proprietary laboratories.

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Safety of Imported and Exported Products Export of Recalled and Nonconforming Products (§221) Section 221 of the CPSIA amends CPSA §18 (codified at 15 U.S.C. §2067) to authorize the CPSC to ban the exportation from the United States of any consumer product that does not comply with U.S. consumer product safety rules, unless the importing country permits importation of such product into that country. The CPSC must notify the importing country of the impending shipment. If the importing country has not notified the CPSC of its import permission within thirty days of the CPSC notice, the CPSC may take appropriate action to dispose of the product. These restrictions do not apply to the exportation of a product refused admission into the United States and permitted by U.S. customs authorities to be exported in lieu of destruction. Related conforming amendments are also made to the FFA. Prior to amendment, CPSA § 18 permitted the export of products that do not comply with U.S. consumer safety rules to other countries, requiring only that the CPSC had to notify the appropriate agencies in the foreign countries that such products were being exported to those countries. Development of Methodology to Identify Unsafe Imports (§222) Section 222(a and b) of the CPSIA (15 U. S.C. §2066 note) requires the CPSC, within two years of enactment of the act, to develop a risk assessment methodology to identify consumer product shipments that are intended for import into the United States and are likely to include products that violate CPSA § 17(a) (15 U.S.C. §2066(a)) and other import laws enforced by the CPSC. In developing this methodology, the CPSC is required to

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use, as far as practicable, the International Trade Data System (ITDS) established under the Tariff Act of 1930 to evaluate and assess information about shipments of consumer products intended for import into the United States; incorporate this methodology into its information methodology modernization plan; and examine how to share information maintained by the CPSC, including the public database and substantial product hazard list, for the purpose of identifying shipments of noncompliant products. Section 222(d) of the CPSIA requires the CPSC, not later than 180 days of completion of the risk assessment methodology, to submit a report to the appropriate congressional committees including

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a plan for implementing the methodology; an assessment of whether the CPSC requires additional statutory authority to implement the methodology; the level of appropriations necessary to implement the methodology; changes made or to be made to the CPSC memorandum of understanding with the CBP; the status of CPSC access to the Automated Targeting System and the development of the Automated Targeting system rule; and the status of the effectiveness of the International Trade Data System in enhancing cooperation between the CPSC and CBP to identify non-compliant shipments.

Cooperation with U.S. Customs and Border Protection (§222(c)) Section 222(c) of the CPSIA (15 U.S.C. §2066 note) requires the CPSC, within one year of enactment of this act, to develop a plan for sharing information and coordinating with CBP to improve enforcement and consumer protection. This plan must consider the number of CPSC personnel that should be stationed at U.S. ports of entry to identify shipments of consumer products that violate import safety laws enforced by the CPSC; the nature and extent of cooperation between CPSC and CBP personnel in identifying such noncompliant shipments; the number of CPSC personnel that should be stationed at the National Targeting Center of CBP, including the nature and extent of cooperation with the CBP, the responsibilities of the CPSC personnel, and usefulness of information at the Center in identifying noncompliant shipments; the development of rules for the Automated Targeting System and expedited access of the CPSC to the System; and the information and resources necessary for the development, updating, and effective implementation of the risk assessment methodology.

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Substantial Product Hazard List and Destruction of Unsafe Imports (§223) Section 223 of the CPSIA adds a new subsection (j) to CPSA §15 (codified at 15 U.S.C. §2064(j)) requiring the CPSC to specify by rule, for any consumer product or class of products, characteristics that constitute a substantial product hazard, if such characteristics are readily observable and covered by voluntary standards that have been effective in reducing the risk of injury and experience substantial compliance. A person adversely affected by such a rule may petition for judicial review under the CPSA not later than 60 days after promulgation of the rule. CPSIA §223 amends a couple provisions to require rather than permit certain actions with regard to imports. CPSA §17(e) (codified at 15 U.S.C. §2066(e)), formerly permitting CBP to destroy products refused importation into the United States in lieu of exportation, is amended to require the destruction of such products unless the CBP permits export in lieu of destruction and such products are exported within ninety days of export approval. CPSA § 17(g) (codified at 15 U.S.C. § 2066(g)), formerly permitting the CPSC, at its discretion, to condition importation on a manufacturer‘s compliance with inspection and recordkeeping requirements, is amended to require manufacturers of imports to comply with all inspection and recordkeeping requirements or the products will be refused admission. The CPSC must advise the customs authorities of who is not in compliance. A related new subsection (d) of CPSA §16 (codified at 15 U.S.C. §2065(d)) requires the CPSC, by rule, to condition manufacturing, selling, distributing, or importing any consumer product or other product on the manufacturer‘s compliance with the inspection and recordkeeping requirements of the CPSA and the related rules. Study of CPSC Authority Related to Imported Products (§225) Section 225 of the CPSIA requires GAO, within one year of the enactment of this act, to conduct a study of the authorities of the CPSA to assess their effectiveness in preventing the importation of unsafe consumer products and to submit a report of its findings to the appropriate congressional committees. This report must include recommendations with respect to plans to prevent such importation; inspection of foreign manufacturing plants by the CPSC; and a requirement that foreign manufacturers consent to the jurisdiction of U.S. courts for enforcement actions by the CPSC.

Miscellaneous Provisions Adoption of a Mandatory All-Terrain Vehicles (ATVs) Safety Standard (§232) CPSIA §232 adds a new CPSA §42 (15 U.S.C. §2089), requiring the CPSC to publish in the Federal Register, as a mandatory consumer product safety standard, the American National Standard for Four Wheel All-Terrain Vehicles Equipment Configuration and Performance Requirements developed by the Specialty Vehicle Institute of America (American National Standard ANSI/SVIA-1-2007). It is unlawful for a manufacturer or distributor to import or distribute a non-compliant ATV in commerce in the United States or, until a three- wheel ATV standard is issued, a new three-wheeled ATV. Upon revision of these standards by the standard-setting organizations, the CPSC must incorporate by a rule revisions that are related to safe performance and any additional changes necessary to reduce

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an unreasonable risk of injury. The CPSC must also consider strengthening additional ATV safety standards.

Formaldehyde Study (§234) GAO is required to conduct a study on the use of formaldehyde in the manufacturing of textiles and apparel not later than two years after the enactment of the CPSIA.

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Expedited Judicial Review CPSIA §236 provides for expedited judicial review of a consumer product safety rule relating to the identification of substantial hazards under CPSA § 15(j); all-terrain vehicles under CPSA §42; durable infant and toddler products under CPSIA § 104; and mandatory toy safety standards under CPSIA § 104. A person adversely affected by such a rule may petition in the U.S. Court of Appeals for the District of Columbia Circuit for expedited judicial review of the rule within 60 days of its promulgation. The judgment of the court affirming or setting aside the rule is final, subject to review by the U.S. Supreme Court. A rule to which expedited judicial review applies is not subject to judicial review in proceedings relating to imported products under CPSA § 17 or in civil or criminal proceedings for enforcement. Definitions Among other technical and conforming changes, CPSIA §235 adds definitions for ―appropriate congressional committees,‖ ―children‘s product,‖ and ―third-party-logistics provider.‖ ―Appropriate congressional committees‖ are defined as the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation of the Senate. ―Children‘s product‖ is defined as a consumer product designed or intended primarily for children 12 years of age or younger. Several factors are to be considered in determining whether a product is primarily intended for a child 12 years of age or younger, including a manufacturer statement or label about the intended use of the product; whether the packaging, display, promotion or advertising of the product represents it as appropriate for use by children 12 years of age or younger; whether the product is commonly recognized by consumers as being intended for use by children 12 years of age or younger; and the Age Determination Guidelines issued by the CPSC in 2002.75 ―Third-party logistics provider‖ is defined as a person who solely receives, holds or otherwise transports a consumer product in the ordinary course of business but who does not take title to the product. CPSIA §235 also adds third-party logistics providers to the list of carriers that are not deemed to be manufacturers, distributors, or retailers of a consumer product under the CPSA solely by reason of receiving or transporting a consumer product in the ordinary course of their business and thus are exempt from the requirements of the CPSA. Pool and Spa Safety Act Technical Corrections CPSIA §238 amends the Virginia Graeme Baker Pool and Spa Safety Act76 by adding a definition of ―state‖ to the act and by providing for the adoption by the CPSC of revisions made to the pool and spa safety standard by the American Society of Mechanical Engineers, an independent standard-setting organization (the earlier act had mandated adoption of the voluntary standard).

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Provisions Deleted in the Conference Agreement The Senate Text contained several provisions concerning consumer safety product standards or studies concerning specific consumer products that did not have counterparts in the House Text and ultimately were not included in the final text of the conference agreement,77 including (section numbers from Senate Text) garage door openers (§3 1); carbon monoxide poisoning from portable gas generators and charcoal briquettes (§32); cigarette lighters (§33); and equestrian helmets (§41). Although the House Text did not include such provisions because its sole focus was reform of the CPSC and its authority and enforcement powers, language in H.Rept. 110-501 (2007) directed the CPSC to take action concerning single-product issues, including

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the promulgation by the CPSC of a final rule on cigarette lighters; a public awareness campaign concerning smoke alarms and smoke detection systems; a consideration of a safety standard concerning the warning labels for the lead content of ceramic food containers or serving ware; a consideration of CPSC authority to regulate pet toys that could be used by children and possible rules concerning the lead content and use of lead paint in such pet toys; a consideration of the tipping hazards of home appliances and furniture and possible safety standards; and a study of injuries and deaths related to toy guns and possible rules for marking of toys guns distinguishing them from actual firearms.78 The House Committee on Energy and Commerce noted in its report that it became aware of the potential dangers posed by asbestos in toys late in the legislative process and would take up these issues in subsequent hearings and legislation. The Conference Report echoed all the concerns noted above, directing the CPSC to consider these issues and take action regarding safety standards for such products and hazards.79 Additionally, the Conference Report recognized nanotechnology as a new, emerging technology used in the manufacture of consumer products and expressed its expectation that the CPSC would review the technology and the safety of its application in consumer products.80

End Notes 1

CPSA §3 (codified at 15 U.S.C. §2052). State agencies have jurisdiction over fixed rides that are located in a park in their jurisdiction. 3 CPSA §16 (codified at 15 U.S.C. §2065) and 16 C.F.R. §1118.2. 4 CPSA §19(a)(3) (codified at 15 U.S.C. §2068(a)(3)). 5 CPSA §27 (codified at 15 U.S.C. §2076). 6 CPSA § 17(h) (codified at 15 U.S.C. §2066(h)). 2

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The statute and regulations refer to the Secretary of the Treasury although such functions are now undertaken by Department of Homeland Security (U.S. Customs and Border Protection (CBP)) pursuant to the Homeland Security Act and 19 C.F.R. § §0.1-0.2. 8 CPSA § 17(b) (codified at 15 U.S.C. §2066(b)). 9 Codified at 15 U.S.C. §2068. 10 Codified at 15 U.S.C. §2064. 11 Codified at 15 U.S.C. §1274. 12 Codified at 15 U.S.C. §2064. 13 Codified at 15 U.S.C. §1273(d). 14 Codified at 15 U.S.C. §2064. 15 Its policy on imported products, importers, and foreign manufacturers is set out at 16 C.F.R. §1009.3. 16 CPSA §3(a)(4) (codified at 15 U.S.C. §2052(a)(4)). 17 See FHSA §15(f) (15 U.S.C. §1274(f)); FFA §9 (15 U.S.C. §1198). 18 CPSA § 15(d) (codified at 15 U.S.C. §2064(d)). 19 CPSA §17 (codified at 15 U.S.C. §2066). 20 CPSA § 17(b) (codified at 15 U.S.C. §2066(b)). 21 16 C.F.R. §1115.21(d). 22 Codified at 15 U.S.C. § 1273. 23 Codified at 15 U.S.C. §1198. 24 Codified at 19 U.S.C. §1499. 25 CPSA §17(c and e) (codified at 15 U.S.C. §2066(c and e)). 26 CPSA §17(c and d) (codified at 15 U.S.C. §2066(c and d)). 27 CPSA § 17(e) (codified at 15 U.S.C. §2066(e)). 28 CPSA §§16(d) and 17(g) (codified respectively at 15 U.S.C. §§2065(d) and 2066(g)). 29 CPSA § 22 (codified at 15 U.S.C. §2071). 30 CPSA § 15(e) (codified at 15 U.S.C. §2064(e)) for recall reimbursement and CPSA §3(a)(1 1) (codified at 15 U.S.C. §2052(a)(1 1)) for definition of ―manufacturer.‖ 31 See CPSA § 15(e) (codified at 15 U.S.C. §2064(e)) and Riegel Textile Corp. v. Celanese Corp., 493 F. Supp. 511 (S.D.N.Y. 1980) (manufacturer has no cause of action against supplier under CPSA or FHSA for violation of those statutes, but state cause of action under state laws may remain). 32 Codified at 15 U.S.C. §2066(f). 33 Codified at 15 U.S.C. §1273(c). 34 Id. 35 16 C.F.R. § 1000.21. 36 Video and slide presentations for the meeting on September 4, 2008, and information on future meetings about testing and certification and standards for all-terrain vehicles, lead, and phthalates, is available at [http://www.cpsc.gov/about/cpsia/cpsia.html], last visited September 22, 2008. 37 After the House passed H.R. 4040, the Senate took up S. 2663, a compromise version of S. 2045, and amended it on the Senate floor, then amended H.R. 4040 to substitute the text of S. 2663 and passed it. 38 The short title for the Senate version of the bill is the CPSC Reform Act. 39 The short title for the House version of the bill is the Consumer Product Safety Modernization Act. 40 See CPSC Press Release 08-349, Chairman Nord‘ s statement, dated July 31, 2008, available at [http://www.cpsc.gov/cpscpub/prerel/prhtml08/08349.html] (last visited September 19, 2008), and Commissioner Moore‘s statement, dated July 31, 2008, available at [http://www.cpsc.gov/pr/Moore073 108cpsia.pdf] (last visited September 19, 2008). 41 Cheryl A. Falvey, CPSC General Counsel, the CPSC Office of General Counsel, Memorandum on Retroactive Application of CPSIA to Inventory (September 12, 2008). 42 Third Party Testing for Certain Children‘s Products: Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies To Assess Conformity With Part 1303 of Title 16, Code of Federal Regulations, 73 Fed. Reg. 54564 (2008). 43 For an analysis of this issue, see CRS Report RL34572, Phthalates in Plastics and Possible Human Health Effects, by Linda-Jo Schierow and Margaret Mikyung Lee. 44 106 Stat. 1571, 1596 (1992) (codified as amended at 15 U.S.C. §2053 note). 45 The funding limitation dates back to § 101(b)(1) of P.L. 99-434, which incorporated by reference H.R. 5313, the Department of Housing and Urban Development-Independent Agencies Appropriations Act, 1987, as passed by the House, which contained the limitation. At that time, based on discussions with the authorizing committee and consumer groups, the House Committee on Appropriations concluded that the five-member structure could not be justified any longer and urged consideration of a change to a single administrator heading the agency. The committee‘s apparent interim solution was in effect to have a three-member Commission. H.Rept. 99-731 [for H.R. 5313] at 21 (1986). See also GAO Report HRD-87-47, Consumer Product Safety Commission: Administrative Structure Could Benefit From Change (1987); Robert S. Adler,

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From “Model Agency” to Basket Case — Can the Consumer Product Safety Commission Be Redeemed?, 41 Admin. L. Rev. 61, 82-92 (1989). 46 H.Rept. 101-914, at 18 (1990). 47 Implementing Recommendations of the 911 Commission Act of 2007, 121 Stat. 266, 543. 48 Actual staffing level was 393 full-time equivalent staff in FY2007; 420 was planned for FY2008; and 444 was requested for FY2009. CPSC, 2009 Performance Budget Request, at 78 (February 2008). 49 The link is at the bottom of the CPSC home page at [http://www.cpsc.gov] and the anonymous report form is on the Inspector General website at [http://www.cpsc.gov/cgibin/ igform.aspx], both last visited September 19, 2008. 50 154 Cong. Rec. S1561-2 (March 5, 2008) (remarks of Senator Klobuchar). 51 154 Cong. Rec. S1575 (March 5, 2008) (remarks of Senator Klobuchar). 52 GAO Report GAO/HEHS-97-147, Consumer Product Safety Commission: Better Data Needed to Help Identify and Analyze Potential Hazards, at 21-22 (1997). 53 In accordance with statutory guidelines, the amounts specified in the statute before amendment by the CPSIA, $5,000 and $1.25 million, were adjusted for inflation in 2004 to $8,000 and $1.825 million for individual violations and a related series of violations, respectively. 69 Fed. Reg. 68884 (2004). 54 See H.Rept. 101-567 at 17 (1990), and H.Rept. 101-914 at 28 (1990), referring to private enforcement actions by interested parties including state attorneys general; see also Consumer Federation of America and U.S. Public Interest Group v. Consumer Product Safety Commission, 990 F.2d 1298, fn. 12 at 1304 (1993) (seventeen state attorneys general signed an amicus brief in which, inter alia, they ―emphasize that they ‗have the authority under [the CPSA private enforcement provision] and [their states‘] consumer protection statutes to enforce [a youth] ban on behalf of [their] citizens‘‖ (the ―youth ban‖ refers to a rule that would ban all new adult-size ATVs for use by children under 16 years old). 55 These violations include prohibitions on the sale of noncompliant products or recalled products, failure to certify or label products, false certifications or labeling, false safety certification marks, stockpiling of products before the effective date of a new standard, and violation of a cellulose insulation standard. The CPSIA does not authorize state attorneys general to enforce certain violations that involve requirements specific to federal authorities, such as not making facilities or records available for inspection by CPSC officials and failure to provide certain information or notification to the CPSC as required. 56 In addition to the aforementioned FHSA and FFA provisions, codified at 15 U.S.C. §1264(d) and 15 U.S.C. §1194(a), respectively, see e.g., 5 U.S.C. §15c (codified provision of the Clayton Antitrust Act); 15 U.S.C. § 5712(a) (codified provision of the Telephone Disclosure and Dispute Resolution Act of 1992, providing for regulations concerning advertising for, operation of, and billing and collection procedures for, pay-per-call or ―900 number‖ telephone services); 15 U.S.C. § 1603 (codified provision of the Telemarketing and Consumer Fraud and Abuse Prevention Act, providing for regulations defining and prohibiting deceptive, coercive, and invasive telemarketing acts or practices); and 15 U.S.C. §6504 (codified provision of the Children‘s Online Privacy Protection Act, enabling parents to control what information is collected from their children online). These provisions authorize states or state attorneys general on behalf of their states and their citizens to bring civil suits to obtain violations of the relevant federal laws, in some cases, monetary damages as well as injunctive relief. 57 Congress DailyPM (February 20, 2008), available at [http://nationaljournal.com/pubs/ congressdaily/]. 58 Federal employees have whistleblower protection under the Whistleblower Protection Act of 1989, P.L. 101-12, 103 Stat. 16 (codified as amended at 5 U.S.C. §1201 et seq. See alsoCRS Report RL33918, The Whistleblower Protection Act: An Overview, by L. Paige Whitaker. State and local employees may have protection under the laws of their state. The report for S. 2045, an earlier version of the Senate bill concerning consumer product safety reform, described the earlier whistleblower provision as containing an intergovernmental mandate as defined in the Unfunded Mandates Reform Act (UMRA) because it would have required state and local governments to comply with whistleblower protections authorized in the bill. However, the Congressional Budget Office estimated that the costs to governments of complying with the mandate would be small and would not exceed the threshold established in the UMRA. S.Rept. 110-265 at 22 (2008). 59 71 Fed. Reg. 13472, 13496-7 (2006), promulgating 16 CFR Part 1633, with a preemption directive at § N of the notice for the final rule. 60 Section 3(b)(1)(A) of the Executive Order, 61 Fed. Reg. 4729, 4732 (2006), requires agencies to make every reasonable effort to ensure that a regulation, as appropriate, ―specifies in clear language the preemptive effect, if any, to be given to the regulation.‖ 61 Catherine M. Sharkey, Symposium: Is the Rule of Law Waning in America? Twelfth Annual Clifford Symposium on Tort Law and Social Policy: Article: Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DePaul L. Rev. 227, 233 (2007) (citing critics of preemption preambles inside and outside the Consumer Product Safety Commission); Christine H. Kim, The Case for Preemption of Prescription Drug Failure-to-Warn Claims, 62 Food Drug L.J. 399 (2007) (noting criticism of the Bush Administration for using preemption to accomplish ―silent tort reform‖). 62 Id.

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Sharkey, supra note 61, at 245. Sharkey, supra note 61, at 242-7; Kim, supra note 61, at 419-421 (discussing cases in the context of Food and Drug Administration preambles with preemption directives); Thomas C. Galligan, Jr., U.S. Supreme Court Tort Reform: Limiting State Power to Articulate and Develop Tort Law - Defamation, Preemption, and Punitive Damages, 74 U. Cin. L. Rev. 1189, 1223-43 (2006) (discussing leading cases re preemption of state tort claims); Howard L. Dorfman, Vivian M. Quinn & Elizabeth A. Brophy, Presumption of Innocence: FDA‟s Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate, 61 Food Drug L.J. 585, 597-601 (2006) (discussing deference to agency interpretation of rules and regulations; the article generally discusses preemption issues re pharmaceuticals). 65 See, e.g., GAO Report GAO/HEHS-97-147, Consumer Product Safety Commission: Better Data Needed to Help Identify and Analyze Potential Hazards 28-32 (1997), for a discussion of the disclosure rules and policies and the views of industry and consumer advocate groups. 66 H.Rept. 110-787 at 70. 67 Congress DailyPM (for February 20, 2008, and for March 11, 2008), available at [http://nationalj ournal.com/pubs/congressdaily/]. 68 CPSA §5(a) (1) requires the maintenance of an Injury Information Clearinghouse ―to collect, investigate, analyze and disseminate injury data and information relating to the causes and prevention of death, injury and illness associated with consumer products....‖ 69 See [http://www.cpsc.gov/library/neiss.html]. 70 From the CPSC website description of NEISS, available at [http://www.cpsc.gov/cpscpub/ pubs/3002.html]. 71 GAO Report GAO/HEHS-97-147, Consumer Product Safety Commission: Better Data Needed to Help Identify and Analyze Potential Hazards 13-19 (1997). 72 H.Rept. 110-787 at 68 (2008). 73 H.Rept. 110-787 at 71. 74 H.Rept. 110-501 at 39 (2007). 75 Timothy P. Smith, ed., CPSC, Age Determination Guidelines: Relating Children‟s Ages To Toy Characteristics and Play Behavior (2002). 76 P.L. 110-140, title XIV, 121 Stat. 1492, 1794 (2007). 77 P.L. 110-278, the Children‘s Gasoline Burn Prevention Act, 122 Stat. 2602 (2008), adopted safety standards for child-resistant closures on portable gasoline containers similar to Senate Text §28. 78 H.R. 5471, to require the Consumer Product Safety Commission to prescribe rules requiring distinctive markings on toy and look-alike firearms (cosponsored by Towns and Blackburn). 79 H.Rept. 110-787 at 67, 75-77 (2008). 80 Id. at 68.

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In: Consumer Product Safety Commission Issues Editor: Isaac E. Bowman

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Chapter 5

CONSUMER PRODUCT SAFETY IMPROVEMENT ACT (CPSIA): NEW REQUIREMENTS AND EMERGING IMPLEMENTATION ISSUES Margaret Mikyung Lee

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SUMMARY This report will present an overview of issues regarding the implementation of the Consumer Product Safety Improvement Act of 2008 (CPSIA). In addition to strengthening the regulatory and enforcement authority of the Consumer Product Safety Commission, the new law established new safety standards, such as those for lead content and phthalates, and testing and certification requirements, focusing particularly on children‘s products. A range of implementation issues have arisen, including uncertainty about possible exemptions to and appropriate compliance with new standards, compliance with testing and certification requirements, disputes about Commission interpretation of new standards, and the particular concerns of small businesses and of non-profit resellers. For additional information on implementation issues, see CRS Report RS22821, Consumer Product Safety Commission: CPSIA Implementation, by Bruce K. Mulock. For a summary of the provisions in the CPSIA, including those not described in this report, see CRS Report RL34684, Consumer Product Safety Improvement Act of 2008: P.L. 110-314, by Margaret Mikyung Lee.

INTRODUCTION In August 2008, the Consumer Product Safety Improvement Act of 2008 (CPSIA) was enacted in response to consumer alarm about the safety of toys and children‘s products and concern about the effectiveness of the Consumer Product Safety Commission (CPSC) and of the statutory and regulatory framework for consumer product safety. Consumer attention and

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concern were roused by several well-publicized national recalls of various toys and children‘s products. In addition to strengthening the regulatory and enforcement authority of the CPSC, the new law established new safety standards, such as those for lead content and phthalates, and testing and certification requirements, focusing particularly on children‘s products. A range of implementation issues have arisen. New safety standards and testing and certification requirements have caused confusion and concern about possible exemptions to and appropriate compliance with new standards, compliance with testing and certification requirements, and disputes about CPSC interpretation of new standards. Despite the efforts of the CPSC to issue implementing regulations and guidelines in a timely manner, a number of unanswered questions and lack of clarity remain, particularly among small manufacturers, second-hand retailers, and manufacturers/retailers of certain types of consumer products. Increased statutory penalties and potential applicability of certain state laws have added to uncertainty about what constitutes compliance with the new requirements of the CPSIA. This report will describe the new requirements for certification and testing and the effect of the stay of enforcement of these requirements announced by the CPSC, certain new safety standards established by the CPSIA and related implementation actions and issues, implementation issues faced by small businesses and second-hand retailers, and legislative proposals to amend the CPSIA to provide for exemptions from certain requirements and for special consideration for small businesses and second-hand retailers.

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Definition of Consumer Product An understanding of what products are covered by the CPSIA and other consumer product safety statutes is necessary as context for consideration of the CPSIA implementation. The Consumer Product Safety Act (CPSA, 15 U.S.C. §§2051 et seq.) defines ―consumer product‖ as ―any article or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.‖1 Not all products that might be considered consumer products under the general definition are subject to consumer product safety laws administered and enforced by the Consumer Product Safety Commission (CPSC). There are express exemptions for products covered under other statutes, including tobacco and tobacco products, motor vehicles and motor vehicle equipment, pesticides, firearms/antique firearms and ammunition/supplies (except for fireworks), aircraft and components, boats and other marine vessels, drugs, medical devices, cosmetics, food, or any article which is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer. The CPSC also has jurisdiction over amusement rides that are not permanently fixed to a site but rather are part of a travelling carnival or show, but does not have jurisdiction over rides that are permanently fixed to a particular site.2 Furthermore, the CPSC has no jurisdiction to regulate a particular consumer product if the risk of injury associated with that product could be eliminated or sufficiently reduced by actions taken under the Occupational Safety and Health Act of 1970 (Occupational Safety and Health Administration), under the Atomic Energy Act of 1954 (the

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Energy Research and Development Administration [now Department of Energy] and the Nuclear Regulatory Commission), or under the Clean Air Act (the Environmental Protection Agency). The CPSC has no authority to regulate any risk of injury associated with electronic product radiation emitted from an electronic product if such risk may be regulated under the Public Health Act (the Food and Drug Administration).

Definition of Children's Product The CPSIA added a definition of ―children‘s product‖ to the CPSA.3 Before the CPSIA, the various consumer product safety statutes made no distinction between children‘s products and other consumer products. Some of the new requirements established by the CPSIA necessitated a definition of what constituted a ―children‘s product.‖ ―Children‘s product‖ is a consumer product designed or intended primarily for children 12 years of age or younger. Several factors are to be considered in determining whether a product is primarily intended for a child 12 years of age or younger, including: a manufacturer statement or label about the intended use of the product; whether the packaging, display, promotion, or advertising of the product represents it as appropriate for use by children 12 years of age or younger; whether the product is commonly recognized by consumers as being intended for use by children 12 years of age or younger; and the Age Determination Guidelines issued by the CPSC in 2002.4

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CERTIFICATION AND TESTING In light of the confusion and misunderstanding regarding the certification and testing requirements of the CPSA as amended by the CPSIA, this section will summarize these requirements and the CPSC‘s limited stay of enforcement. There are two types of compliance certification requirements: (1) a general conformity certification for consumer products, not just children‘s products, based on testing of each product or a reasonable testing program by the manufacturer and (2) a certification for children‘s products based on testing by a thirdparty laboratory. Until a third-party testing requirement takes effect for a safety standard applying to children‘s products, a general conformity certification applies to that safety standard. The certification requirement applies to products manufactured on or after November 12, 2008. The third-party testing and certification requirements take effect at different times, on a rolling basis.5 Both types of certification are required of either the manufacturer (domestic product) or importer (imported product), not of a retailer or distributor. The CPSIA added a requirement that the certificates must ―accompany‖ each product or shipment of products subject to the certification requirements and be ―furnished‖ to each distributor or retailer of the product. In addition, a copy of the certificate must be ―furnished‖ to the CPSC upon request. Under the CPSA as amended by the CPSIA, the CPSC has the authority to designate by rule whether the manufacturer or importer (or private labeler) must

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issue the required certificate and to relieve the other parties from the requirement to furnish certificates.6

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General Conformity Certification The CPSA requires all manufacturers and importers—not just those that manufacture or import children‘s products—to certify they have complied with all applicable safety rules, bans, standards, and regulations under statutes enforced by the CPSC. Applicable safety rules do not include voluntary safety standards, only mandatory standards, such as those in title 16 of the Code of Federal Regulations, that have been promulgated under a statute enforced by the CPSC. Aside from the CPSA, these include the Federal Hazardous Substances Act, the Flammable Fabrics Act, the Poison Prevention Packaging Act, and the Refrigerator Safety Act, miscellaneous statutes providing for specific safety standards.7 The certification must assert compliance with all standards that apply to a product and must be based on a test of each product or on a reasonable testing program. The manufacturer or importer may conduct the test in-house and is not required to have testing done by a third-party/independent laboratory. The manufacturer or importer may determine for itself what constitutes a reasonable testing program. Generally, the CPSC does not examine or investigate the testing program of a particular manufacturer or importer, although the CPSC can prescribe what constitutes a reasonable testing program for a particular safety standard. The CPSC has not prescribed what constitutes a reasonable testing program for the any of the new standards under the CPSIA. The CPSIA did not establish the general conformity certification requirement, but expanded the certification requirement‘s scope to all safety standards under all statutes enforced by the CPSC. Previously, the requirement only applied to safety standards under the CPSA. Because of the expanded scope of this requirement and the new safety standards under the CPSIA, products that previously were not subject to this requirement now are, to the surprise of some manufacturers and importers. The CPSIA also added products imported for consumption and warehousing to the list of products requiring general conformity certification.8 Previously, any products imported for distribution in commerce were subject to general conformity certification; products imported directly by the end consumer or imported for holding/storage in a warehouse (not for distribution and sales) did not require general conformity certification.9

Children's Product Third-Party Testing and Certification Unlike the general conformity certification requirement, the requirement for testing and certification of children‘s products was newly established by the CPSIA. As noted in the previous section, for the general conformity certification, determining and assuring compliance with safety standards was largely left up to the manufacturer or importer. The Senate report for S. 2045, the Consumer Product Safety Commission Reform Act of 2007 (originally the Senate counterpart to H.R. 4040 which became the CPSIA), noted that ―the [new third-party testing and] certification requirement would likely impose new costs on all

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manufacturers of children‘s products since currently manufacturers either self-certify or do not certify products at all.‖10 However, under the CPSIA, a manufacturer and/or importer must certify compliance of children‘s products with applicable safety standards based on testing by accredited third-party laboratories. Testing may be done by in-house, proprietary laboratories of a manufacturer only under certain conditions, such as firewalling (insulation and independence from influence and direction of the manufacturer concerning testing) and appropriate accreditation. The CPSIA required the CPSC to issue accreditation requirements for such laboratories and maintain a list of accredited laboratories and set deadlines by which the CPSC was required to publish accreditation requirements based on the type of product being tested by the laboratory. Specific, staggered deadlines for publication of accreditation requirements were established for the testing of lead paint (September 13, 2008, but actually published September 22, 2008), cribs and pacifiers (October 13, 2008, but actually published October 22, 2008), small parts (November 12, 2008, but actually published November 17, 2008), children‘s metal jewelry (December 12, 2008, but actually published December 22, 2008), and baby bouncers/walkers/jumpers (due March 12, 2009, but not published). The staggered deadlines facilitated gradual phasing in of the new requirements. The CPSIA required the accreditation requirements related to the testing of other children‘s products to be published as early as practicable, but no later than June 14, 2009, or, for safety rules established or revised on or after August 14, 2009, not later than 90 days before such rules take effect. The accreditation guidelines for certain products have been completed and testing and certification is already in effect for those safety standards.11 The CPSIA requires testing and certification for any children‘s product manufactured more than 90 days after the laboratory accreditation guidelines are published for a safety standard. Based on the actual publication date of the relevant accreditation guidelines, certification and testing is required for lead paint on children‘s products manufactured after December 21, 2008; for cribs and pacifiers manufactured after January 20, 2009; for children‘s products with small parts manufactured after February 15, 2009; and for children‘s metal jewelry manufactured after March 23, 2009.12 The accreditation guidelines and testing and certification requirements have not been published nor implemented for baby bouncers/walkers/jumpers, apparently because the CPSC would have to issue guidelines in accordance with current regulations that are outdated and are not being followed instead of being able to issue guidelines in accordance with up-to-date voluntary standards recognized by the CPSC.13 These guidelines may also have been delayed in accordance with the stay of enforcement discussed in the next section.

Stay of Enforcement of Certification and Testing The CPSC has announced a stay of federal enforcement for certain certification and testing requirements for one year, effective February 10, 2009.14 Both general conformity and children‘s product third-party testing and certification are stayed for lead content (but not for lead-based paint), phthalates standards, and mandatory toy standards. There is no stay of enforcement for certification and testing that had already been implemented or for which the accreditation guidelines had already been published as of the date of the stay.15 Nor did the

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CPSC stay the safety standards themselves or the required compliance with such standards. Therefore, if a product does not comply with a safety standard and such noncompliance is discovered, the manufacturer and/or importer may be liable civilly and criminally for such noncompliance and may be subject to private lawsuits. The CPSC stay of enforcement also does not stay enforcement by state attorneys general, so theoretically, a state could enforce the certification and testing requirement. For example, a state could enjoin sales and distribution in that state of products that do not comply with this requirement.

APPLICABILITY OF CERTAIN NEW PRODUCT STANDARDS The implementation of new product standards for lead and phthalates in particular have caused controversy. CPSC has no authority to delay or suspend the safety standards and on these grounds has declined to stay effective dates.

Lead

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CPSIA § 101 established a lead safety standard for lead content in children‘s products and amended the safety standard for lead in paint or coatings for certain consumer products. The new standard for lead content in children‘s products has provoked consternation among manufacturers of some products who assert that there should be an exemption for certain products presenting a ―low risk‖ of exposure to lead.16

Lead-Based Paint Standard and Inventory Lead in paint standards have existed since the 1970s. The current regulatory standard prohibits the use on children‘s products and furniture of paint or other surface coatings with a lead content exceeding 0.06 % by weight of the total nonvolatile content of the paint or the weight of the dried paint film.17 CPSIA § 101(f) reduces the permissible trace amount of lead in paint to 0.009 % (90 ppm) from 0.06 % (600ppm), subject to subsequent periodic review and further reduction to the lowest lead level technologically feasible. The more stringent standard will take effect August 14, 2009.18 A CPSC Office of General Counsel memorandum concerning the application of CPSIA lead standards to inventory clarifies that inventory of noncompliant products may not be sold after the new standard for lead in paint takes effect on August 14, 2009.19 Although the CPSIA does not expressly ban such sale or distribution, the Office of General Counsel concludes that a reading of the CPSIA as a whole indicates such an interpretation. Lead Content/Substrate Standard Inventory Manufactured before Effective Date of New Standard Under the CPSIA § 101(a)(2), the permissible lead level in products for children aged 12 and younger is being progressively reduced over three years: 600 parts per million (ppm) as of February 10, 2009; 300ppm as of August 14, 2009; and 100ppm as of August 14, 2011. If

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100ppm is not technologically feasible, the CPSC must set the lowest level that is technologically feasible. After promulgating either the 100ppm level or the lowest level technologically feasible, the CPSC is required to review and lower the limit at least every five years. The CPSC Office of General Counsel memorandum concerning lead standards and inventory concluded that inventory of noncompliant products may not be sold after the effective dates of each phase of the lead standard.20 After August 14, 2009, inventory of children‘s products that contain more than 300ppm cannot be sold and after August 14, 2011, inventory of children‘s products that contain more than 100ppm cannot be sold.

Statutory Exemptions and Implementing Regulations The CPSIA § 101(b) provides for several exemptions from the lead content/substrate standard. The CPSC has issued several proposed and final regulations with regard to various authorized exemptions. Through a rulemaking with notice and opportunity for a hearing, the CPSC may exempt certain noncompliant materials or products from being subject to the standard if it determines on the basis of the best-available, objective, peer-reviewed, scientific evidence that the lead in the products or materials will not ―result in the absorption of any lead into the human body ... nor ... have any other adverse impact on public health or safety.‖21 In considering whether any lead will be absorbed, the CPSC must take into account normal and reasonably foreseeable use and abuse of a product by a child, including swallowing, mouthing, breaking, or other activities, and the aging of the product. The CPSC‘s rules for requesting and determining such exemptions22 requires its Office of Hazard Identification and Reduction (EXHR) to make an initial recommendation within 30 calendar days, to ―the extent practicable‖23 or to request an extension from the Executive Director of the CPSC. The rule does not specify any timeline for a final decision by the CPSC and provides that the filing of an exclusion request does not stay the lead standard or related certification or other requirements for the subject of the request pending a final decision by the CPSC.24 The exclusion request must include the bestavailable, objective, peer-reviewed, scientific evidence that is unfavorable to the request and that is reasonably available to the requestor, as well as evidence that supports the request.25 Any initial decision of the CPSC to grant an exclusion request, whether upon or against the initial recommendation of the EXHR, shall be published in the Federal Register for comment.26 A requestor will be notified of an exclusion denial; an exclusion grant will be published as a final rule in the Federal Register.27 The lead content standards under the CPSIA shall not apply to any inaccessible component parts of a children‘s product. A component part is not accessible if it is ―not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product. Reasonably foreseeable use and abuse shall include to [sic], swallowing, mouthing, breaking, or other children‘s activities, and the aging of the product to a child during normal and reasonably foreseeable use and abuse of the product.‖28 Pursuant to the CPSIA, the CPSC has proposed an interpretative rule to provide guidance with respect to what product components or classes of components will be considered to be inaccessible.29 The preamble to the proposed rule describes an inaccessible component as one that is inside a product which a child cannot touch and that may be encased in material such as plastic, rubber, or metal.30 The CPSC sought comments as to whether fabric should be considered a barrier rendering lead

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inaccessible to a child;31 a final rule has not been issued, so it is unclear whether fabric will be included as a barrier.32 Inaccessibility would be determined by the manufacturer using existing use and abuse tests33 and accessibility probes34 required under current CPSC regulations. If the CPSC determines that it is not technologically feasible for certain electronic devices to comply with the lead standard, it must also issue requirements to minimize exposure or accessibility to lead in those devices. Such requirements may include a childresistant cover that prevents exposure to and accessibility of the parts containing lead. The CPSC has issued an interim final rule concerning certain electronic devices for which it is not technologically feasible to meet the lead limits as required under CPSIA § 101.35 For the purpose of the exemptions described above, paint, coatings, or electroplating are not considered to be a barrier that would render lead in the substrate inaccessible to a child, or to prevent absorption of any lead into the human body. 36 The CPSC has proposed a list of inherently lead-free materials, including precious metals and all-natural-fiber textiles37 and has also issued a Statement of Commission Enforcement Policy on Section 101 Lead Limits.38 A final list has not yet been promulgated. With regard to materials and products not on this list, manufacturers and importers may request a CPSC determination that a commodity or class of materials or a specific material or product does not exceed the lead content limits specified under CPSIA §101(a).39 The procedure is similar to the one for determining exclusions of certain noncompliant products and materials, with similar deadlines and notice and comment provisions.

Applicability to Specific Products The CPSC General Counsel has issued opinions concerning the applicability of the lead standard to books (and certain other paper-based products such as posters and games), apparel/shoes, All-Terrain-Vehicles (ATVs), bicycles, and small motorcycles/dirt bikes. In its response to comments by ATV manufacturers on the rule regarding the procedure for applying for and granting exclusions of noncompliant products from the standard, the CPSC asserted that the pertinent statutory language does not allow it any discretion to grant the requested exclusion. Specifically, the CPSC concluded that allowing exclusions where ―no meaningful increase‖ in lead levels in the human body could occur meant that exclusions would be permissible only in cases where the lead in a product or material will not result in the absorption of any lead into the human body.40 Thus, the CPSC implied that any exemption for metal parts of products such as ATVs, bicycles, and small motorcycles/dirt bikes may require legislation to amend the CPSIA‘s exemption language41 requiring zero absorption of lead by a person. Since the CPSC issued the final rule regarding the procedure for applying for and granting exclusions of noncompliant products from the standard or determinations that a material/product is inherently compliant, there have been several applications for exemption or determination. The CPSC has decided only one as of the date of this report, an application by several manufacturers and industry groups with regard to ATVs, which the CPSC denied.42 The exclusion was denied because metal parts of ATVs are not covered by the statutory exclusion language, consistent with the CPSC position asserted in the Federal Register notice for the final rule on the exclusion procedure. However, the CPSC announced in the Commissioners‘ statements accompanying the vote that the Commissioners and staff were working to develop a plan to stay enforcement of lead content standards as applied to

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ATVs.43 A CPSC vote on the stay of enforcement is scheduled for April 24, 2009; the stay would cover ATVs manufactured before or on May 1, 2011, the date the stay ends.44 The stay for such ATVs would remain in effect for the life of the ATVs and any replacement parts for those ATVs.45 Manufacturers seeking the protection of the stay would have to submit a request specifying vehicles and parts covered by the stay within 45 days of the issuance of the stay and explain why such vehicles and parts cannot be made inaccessible, substituted with another material, or made compliant at this time.46 In a letter to the CPSC, several Senators have expressed the opinion that the exclusion language of the CPSIA §101(b)(1)(A) gives the CPSC the discretion to grant an exclusion for conditions like that of the ATVs and to implement the CPSIA in a common-sense manner.47 These opinions echo those of a Senate conferee on the CPSIA cited by the ATV manufacturers in their comments on the rule for the exclusion procedure.48

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Phthalates Inventory Manufactured before Effective Date (Court Ordered Application) In NRDC, Inc. v. United States Consumer Prod. Safety Comm‟n,49 a lawsuit filed by consumer advocacy groups,50 a federal district court struck down an advisory opinion of the CPSC‘s Office of General Counsel (OGC) that interpreted the phthalates ban as applying only to products manufactured after the effective date of the new ban (February 10, 2009) and thus effectively permitted the continued sale of existing noncompliant inventory after February 10, 2009.51 Before this court decision, the OGC interpretation had been criticized by congressional proponents of the phthalates standard as being contrary to congressional intent.52 The court found that the text and legislative history indicated clearly that the phthalates standard applied to products manufactured before the effective date of the standard and criticized the OGC analysis, indicating that it was not due deference because it was not thorough, well-reasoned, or substantiated, as required by case- law precedents. The CPSC did not appeal the court‘s decision. Standard Concerns Certain Children's Toys and Children's Products A phthalates safety standard for certain consumer products was established by § 108 of the CPSIA. Beginning 180 days after enactment, § 108 permanently bans the three phthalates whose toxicity is not disputed and temporarily bans three other phthalates pending a review by a Chronic Hazard Advisory Panel (CHAP).53 It prohibits children‘s toys or child care articles that contain more than 0.1 % DEHP, DBP, or BBP. The sale of children‘s toys that can be placed in the mouth or child care articles containing concentrations of more than 0.1 % of DINP, DIDP, or DnOP, is prohibited on an interim basis until a review by a CHAP. After the CPSC receives the report from the CHAP, it must determine, by rule, whether to continue the interim ban. It defines ―children‘s toy‖ as ―a consumer product designed or intended by the manufacturer for a child 12 years of age or younger, for use by the child when the child plays.‖ ―Child care article‖ is ―a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger or to help such children with sucking or teething.‖ The statute includes guidelines for determining whether a product was

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intended or designed for use by children of the specified ages and whether a toy can be placed in a child‘s mouth. The provision does not restrict phthalate alternatives. Section 108 also clarified any preemptive effect these standards would have on state laws. Nonidentical provisions are preempted, unless a state applies for and the CPSC grants an exemption for stronger protections under state laws, and the federal law would not preempt restrictions on phthalate alternatives. The CPSIA standard differs somewhat from existing state laws. For example, the federal law is not identical to the state laws with regard to the definitions of toys, children‘s products, or children‘s articles, and the age group for which these consumer products are intended.54 It appears that the new federal phthalates safety standard preempts recent state laws that were enacted in the absence of federal standards, to the extent that they do not provide identical protection for the same risk of injury.

Applicability to Specific Products The CPSC General Counsel has issued advisory opinions regarding the applicability of the phthalates ban to apparel and shoes.55 The opinions note that under the phthalates ban, apparel and shoes, except for sleepwear, would generally not be considered either toys or child care articles as defined under the statute. Even shoes designed in a whimsical manner designed to appeal to children, generally would not be considered toys. In public meetings conducted by the CPSC staff with regard to the CPSIA implementation, the staff has also acknowledged the issues posed by some home design items and sporting goods.56 For example, it may be unclear whether certain home design products should be considered toys because of their toy-like appearance and whether others are designed for use by the child or by the parent in caring for the child. With regard to certain sporting goods, such as inflatable balls or wading pools, it may be unclear whether the product, when deflated, can normally be mouthed by a child. In addition to the advisory opinions, the CPSC has made available draft guidance regarding what children‘s products are subject to the phthalates ban; the guidance elaborates on what constitutes a toy, a toy that can be placed in the mouth, or a child care article.57 California Phthalates Ban Effective January 1, 2009, a California statute58 prohibits the manufacture, sale, or distribution in commerce of any toy or child care article that contains DEHP, DBP, or BBP in concentrations exceeding 0.1% and of any toy or child-care article, intended for use by children under three years of age that can be mouthed, that contains DINP, DIDP, or DnOP in concentrations exceeding 0.1%. The statute requires manufacturers to use the least toxic alternative when replacing phthalates in such products and also prohibits them from replacing phthalates with certain carcinogens (including substances known, likely to be, or suggestive of being human carcinogens) or reproductive toxicants identified in accordance with federal or California laws. California defined ―toys‖ as ―all products designed or intended by the manufacturer to be used by children when they play,‖59 and ―child care article‖ is defined as ―all products designed or intended by the manufacturer to facilitate sleep, relaxation, or the feeding of children, or to help children with sucking or teething.‖60 The Attorney General of the State of California sent a letter to the CPSC General Counsel setting forth the State‘s position with regard to how the federal and state phthalates laws interact.61 The California Attorney General expresses concern that the CPSC Phthalates

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Opinion did not note the effect of state laws. He asserts that: (1) to the extent the federal phthalates standard and the California standard overlap, they are identical and thus the federal ban does not preempt the state ban; (2) to the extent that the state law covers products that are not covered by the federal ban, the federal ban does not preempt state law; (3) during the period between the effective date of the state ban and the effective date of the federal ban, the federal ban does not preempt state law; and (4) if the federal ban does not cover products manufactured before its effective date, it does not preempt the California phthalates ban, which applies to products manufactured before its effective date. The California Attorney General concludes,

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As of January 1, 2009, it will be illegal to sell, distribute, or manufacture toys and child care articles in California with greater than 0.1 percent of six specified phthalates, regardless of when or where the products were manufactured. The effective date of the federal CPSIA does not affect implementation of California‘s phthalate restrictions. Because A.B. 1108 will have been on the books for over 14 months before its phthalate limits take effect, we believe that industry has had sufficient time to prepare to comply with the requirements that take effect on January 1, 2009. The Attorney General, and other public enforcers, can and will enforce California‘s phthalate ban after that date.62

The CPSC Frequently Asked Questions for the CPSIA simply state that the new federal provisions on phthalates preempt state laws,63 but with regard to the California laws and the California Attorney General‘s letter to the CPSC, a CPSC spokesperson reportedly stated, ―The Consumer Product Safety Commission respects the law as passed in California, and its implementation starting this week.‖64 Additionally, California has petitioned for exemption of certain phthalates statutes from preemption by the new federal toy safety standard, in accordance with CPSIA § 106(h)(2).65 This provision permits state and local governments to petition for exemption of existing state and local toy safety standards from preemption by federal toy safety standard when the state and local laws protect consumers from the same risk of injury as the federal law.

Toy Safety Standard CPSIA §106 mandated adoption of the ASTM International66 Standard F963–07 Consumer Safety Specifications for Toy Safety within 180 days of the CPSIA enactment. Since the enactment of the CPSIA, ASTM International has adopted a new revision to this standard, F963-08. Under the CPSIA, this revision becomes effective as the new standard within 180 days of the ASTM International notification of the revision to the CPSC. The revision is subject to review and adoption (or partial adoption) by the CPSC. If the CPSC notifies the ASTM within 90 days of receiving the revision notification that it will not adopt the ASTM revision, the older standard will remain in effect for the United States. The CPSIA permits certain departures from the ASTM toy standard. Specifically, CPSIA §101 provides that in any conflict with the lead standard under that section, the lead standard under CPSIA § 101 supersedes the ASTM toy standards. Also, states may petition the CPSC for exemption from preemption of state standards. Several states have already done so.

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IMPLEMENTATION CONCERNS OF SPECIFIC STAKEHOLDERS In addition to issues of exemption for specific product categories or the delay of certain requirements of the CPSIA, small businesses and second-hand resellers have asserted that they have particularly suffered a severe economic impact from the CPSIA.

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Small Businesses Small businesses have asserted that the CPSIA disproportionately affects them with regard to inventory loss due to noncompliance with the new lead and phthalates standards and the costs of third-party testing. They have sought relief, either administratively or legislatively, from the application of the new requirements to small businesses. The CPSIA does not expressly permit consideration of the needs of small businesses in the implementation or enforcement of the new requirements, that is, there is no small-business exemption from the requirements. The CPSIA focuses on the product and whether a product meets certain standards. Accordingly, the CPSIA permits the consideration of exemptions based on the threat to public safety posed by types of products or product components, not based on the type of manufacturer or ability of the manufacturer to comply with safety standards. Some small businesses apparently have asserted that manufacturing does not include final ―assembling‖ of component parts, therefore, the work performed by certain small businesses is not manufacturing because it only constitutes ―assembling.‖ However, no distinction is made between large-scale and small-scale manufacturers in either the CPSIA or the primary consumer product safety statutes. The CPSA does not define manufacturers or consumer products subject to consumer product safety laws in terms of the size of the manufacturer, production volume, or method of manufacture (such as mass-production versus handmade production). It defines ―manufacturer‖ as ―any person who manufactures or imports a consumer product‖67 and defines ―manufactured‖ as ―to manufacture, produce, or assemble.‖68 The CPSC has asserted that it has no authority to stay the effective date of the actual safety standards for anyone;69 therefore, there has been no stay of safety standards for small businesses that might suffer a greater economic impact from the requirements of the CPSIA. However, pursuant to existing laws, the CPSC generally considers the needs of small businesses in promulgating regulatory standards pursuant.70 The CPSC issued guidelines for small businesses in which it attempted to clarify the effect of the CPSIA on small businesses.71

Second-hand Resellers Second-hand resellers are not satisfied with CPSC guidelines which advise resellers that they have one of four choices for a product, as a practical matter: (1) test the product; (2) refuse to accept or sell the product and discard any inventory; (3) use the reseller‘s best judgment based on knowledge of the product; or (4) contact the manufacturer about the

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product for information.72 Although the guidelines attempt to provide practical advice to resellers, resellers remain uncertain as to what they are required to do. For example, exactly what constitutes knowledge that a product complies with safety standards is unclear.

State Petitions for Exemption from Preemption Several states have petitioned the CPSC for exemptions from preemption of state safety standards by new standards under the CPSIA.73 Some of the petitions are pursuant to the preemption exemption under CPSIA § 106, the toy standard provision. Others have been filed under the general preemption provisions under the CPSA or the FHSA. The CPSC has not yet acted on any of these petitions.

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LEGISLATIVE PROPOSALS In letters to the CPSC, congressional committees and members have urged the CPSC to expeditiously issue guidelines and exemption regulations, criticized the CPSC for problems with implementation, and asked the CPSC to explain the implementation issues that have arisen.74 The CPSC responded with letters explaining these issues, how they are being handled, and the CPSC‘s views regarding potential solutions, including any need for additional legislation.75 Relief from the deadlines imposed for CPSC action and increased agency discretion to grant exemptions are a couple of the proposed solutions that may entail legislation; component certification is one of the administrative solutions being studied by the CPSC. Additionally, business stakeholders, including manufacturers and second-hand resellers, have been vocal in demanding legislative action to resolve problems businesses perceive in the CPSIA and its implementation.76 Consumer advocates generally appear to be pleased with the CPSIA implementation, with the exception of the OGC memorandum permitting the continued sale of inventory that did not comply with the new phthalates standard.77 They acknowledge the implementation issues that have arisen and the exemptions permitted under the law and have urged the CPSC to issue appropriate guidance and take appropriate steps in its discretion to address these issues.78 They have also urged the President to appoint a new CPSC Chair.79 Some members have urged that hearings be held to consider implementation problems and whether legislation may be appropriate.80 The congressional committees with jurisdiction over the CPSC and consumer product safety issues have not yet held hearings with regard to CPSIA implementation issues, apparently preferring to wait for the appointment of a new CPSC Chair81 and to allow time for the CPSC to address and resolve such issues administratively to the extent feasible. The Chairmen of the congressional committees have urged President Obama to replace Acting CPSC Chair Nord as soon as possible with his own designee.82 The CPSC had been hampered by the absence of additional resources and staff needed to implement the CPSIA effectively. The recent enactment of the Omnibus Appropriations Act, Fiscal Year 2009, P.L. 111-8, provided $105,404,000 to the CPSC, which was acknowledged

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by Acting CPSC Chair Nord as funds urgently needed to implement the CPSIA by hiring additional staff and upgrading databases and technology infrastructure.83 Several bills have been introduced to mitigate the impact of new CPSIA requirements on small businesses and second hand resellers (some of which are non-profit/charitable organizations); delay the effective dates of requirements; and provide exemptions for ATVS, bicycles, motorbikes, and books. Proposed legislation to amend provisions established by the CPSIA include: S. 374, A bill to amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned businesses, related to H.R. 968 and H.R. 1465 (sponsored by Senator Jim DeMint and introduced February 4, 2009); S. 389, to establish a conditional stay of the ban on lead in children‘s products, and for other purposes (sponsored by Senator Robert F. Bennett and introduced February 5, 2009); H.R. 968, to amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned businesses, related to S. 374 (sponsored by Representative John B. Shadegg and introduced February10, 2009); H.R. 1027, Thrift Store Protection Act (sponsored by Representative Bill Posey and introduced February 12, 2009); H.R. 1046, Children‘s Product Safety Enhancement and Clarification Act of 2009 (sponsored by Representative Adam H. Putnam and introduced February 12, 2009); H.R. 1465, to amend the Consumer Product Safety Act to provide regulatory relief to small and family-owned businesses, related to S. 374 (sponsored by Representative Brad Ellsworth and introduced March 12, 2009); H.R. 1510, to amend the lead prohibition provisions of the Consumer Product Safety Improvement Act of 2008 to provide an exemption for certain all-terrain vehicles, and for other purposes, related to H.R. 1587 (sponsored by Representative Denny Rehberg and introduced March 16, 2009); S. 608, Common Sense in Consumer Product Safety Act of 2009 (sponsored by Senator Jon Tester and introduced March 17, 2009); H.R. 1587, to amend the lead prohibition provisions of the Consumer Product Safety Improvement Act of 2008 to provide an exemption for certain off-highway vehicles, and for other purposes (sponsored by Representative Denny Rehberg and introduced March 18, 2009); H.R. 1692, to amend the Consumer Product Safety Improvement Act to exempt ordinary books from the lead limit in such Act (sponsored by Representative Jeff Fortenberry and introduced March 24, 2009); H.R. 1815, to clarify the applicability of certain provisions in the Consumer Product Safety Improvement Act, and for other purposes (sponsored by Representative Joe Barton and introduced March 31, 2009); S.Amdt. 964 to S.Con.Res. 13, to establish a deficit-neutral reserve fund to protect small and home businesses from the burdensome and impractical requirements of the Consumer Product Safety Improvement Act of 2008 (sponsored by Senator Jim DeMint and introduced April 2, 2009). This amendment not agreed to in the Senate by a Yea-Nay vote of 39 to 58 on April 2, 2009 (Record Vote No. 151).

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End Notes 1

CPSA §3(a)(5) (codified at 15 U.S.C. §2052(a)(5)). State agencies have jurisdiction over fixed rides that are located in a park in their jurisdiction. 3 CPSIA §235(a) added CPSA §3(a)(16), codified at 15 U.S.C. §2052(a)(16). 4 Timothy P. Smith, ed., CPSC, Age Determination Guidelines: Relating Children‘s Ages To Toy Characteristics and Play Behavior (2002). 5 The third-party testing and certification requirement for the lead-based paint standard was the first to take effect, on December 21, 2008. Thus, a general conformity certification for the lead-based paint standard (and other standards applicable to a product) had to be issued between November 12, 2008, and December 21, 2008. Since the latter date, a certificate based on third-party testing for the lead-based paint standard must be issued for a children‘s product, together with a general conformity certification for any standards applicable to that product for which third-party testing and certification requirements have not taken effect. 6 In response to concerns about cost and efficiency raised by manufacturers and importers, the CPSC issued regulations permitting general conformity certifications to be electronically submitted and limited submission of the certificates to the U.S. importer or, in the case of domestically produced products, the U.S. manufacturer. It also specified the requirements that an electronic certificate must meet. 73 Fed. Reg. 68328 (Nov. 18, 2008). 7 The Federal Hazardous Substances Act (FHSA, 15 U.S.C. §§1261 et seq.) provides for warning/informational labeling of hazardous substances and for the banning of certain hazardous substances for which labeling would not provide adequate protection for the public against the potential hazards posed by the substances. The Flammable Fabrics Act (FFA, 15 U.S.C. §§1191 et seq.) provides for the establishment of safety standards regarding fabric flammability. It also prohibits the manufacture, sale, importation, transportation, or delivery in commerce of a product, fabric, or related material or of a product made of a fabric or related material that does not comply with the standards and deems that such practices constitute unfair methods of competition and unfair and deceptive acts or practices under the Federal Trade Commission Act. The Poison Prevention Packaging Act (PPPA, 15 U.S.C. §§1471 et seq.) authorizes the CPSC to establish special packaging standards for a household substance if such standards are required to protect children from serious injury or illness from using, handling, or ingesting such substance, with exceptions for noncompliant packages for elderly/handicapped persons and packaging at the direction of a licensed medical practitioner. The Refrigerator Safety Act (RSA,15 U.S.C. §§1211 et seq.) prohibits the introduction into interstate commerce of any household refrigerator that does not conform with certain safety standards. 8 CPSIA §102(a)(1). 9 Import for testing, for demonstration at trade shows, or re-export would not require such certification unless later distributed and sold for consumption. 10 S.Rept. 110-265, at 25 (2008). 11 See accreditation guidelines available at http://www.cpsc.gov/about/cpsia/cpsia.html#requirements. 12 The actual effective date should be March 22, 2009, but the extra day is not explained by the CPSC. 13 CPSC Staff responses to Rep. Dingell‘s questions in an attachment to the Letter from Acting CPSC Chair Nord to Rep. Dingell, dated March 20, 2009, at 4-5, available at http://www.cpsc.gov/about/cpsia/dingell032009.pdf. 14 74 Fed. Reg. 6396 (Feb. 9, 2009). 15 The stay of enforcement does not apply to: (1) general certification required for mandatory safety standards under the CPSA before the CPSIA and any other certifications expressly required by CPSC regulations; (2) thirdparty testing and certification for lead-based paint in children‘s products, cribs and pacifiers, small parts in children‘s products, and children‘s metal jewelry; (3) certifications for pool-drain covers required under the Virginia Graeme Baker Pool & Spa Safety Act; and (4) certifications required for the new ATV standard established by CPSIA §232 (not to be confused with lead content standards that apply to ATVs). 16 See infra note 40. 17 16 C.F.R. §1303.1. This regulatory standard was issued by the CPSC pursuant to its authority under the CPSA and §401 of the Lead-Based Paint Poisoning Prevention Act (42 U.S.C. §4831(c)). 18 This is pursuant to CPSC amendment of the current regulatory standard at 16 C.F.R. §1303.1. 73 Fed. Reg. 77492 (December 19, 2008). 19 Cheryl A. Falvey, CPSC General Counsel, the CPSC Office of General Counsel, Memorandum on Retroactive Application of CPSIA to Inventory (September 12, 2008). 20 Cheryl A. Falvey, CPSC General Counsel, the CPSC Office of General Counsel, Memorandum on Retroactive Application of CPSIA to Inventory (September 12, 2008). 21 CPSIA §101(b)(1)(A) [15 U.S.C. §1278a(b)(1)(A)]. 22 74 Fed. Reg. 10475 (March 11, 2009). The procedure is codified at 16 C.F.R. §1500.90. 23 74 Fed. Reg. at 10481, codified at 16 C.F.R. §1500.90(e). 24 74 Fed. Reg. at 10481, codified at 16 C.F.R. §1500.90(h). 25 74 Fed. Reg. at 10481, codified at 16 C.F.R. §1500.90(c)(6).

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74 Fed. Reg. at 10481, codified at 16 C.F.R. §1500.90(f ) and (g). Id. 28 CPSIA §101(b)(2)(A) [15 U.S.C. §1278a(b)(2)(A)]. 29 74 Fed. Reg. 2439 (Jan. 15, 2009). The rule would be codified at 16 C.F.R. §1500.87. 30 74 Fed. Reg. at 2440. 31 Id. 32 Several comments advocated recognizing fabric as a barrier rendering lead-containing components inaccessible. See comments available at http://www.cpsc.gov/library/foia/foia09/pubcom/Inaccessiblelead1.pdf. The comment period for this proposed rule ended on February 17, 2009. 33 74 Fed. Reg. at 2442, codified at 16 C.F.R. § 1500.87(e) and (f). 34 74 Fed. Reg. at 2442, codified at 16 C.F.R. § 1500.87(d). The probes are currently used to determine whether sharp points or edges in certain children‘s products are accessible based on whether a probe can touch a component inside a product. 35 74 Fed. Reg. 6990 (Feb. 12, 2009). 36 CPSIA §101(b)(3) [15 U.S.C. §1278a(b)(3)]; 74 Fed. Reg. at 2442, codified at 16 C.F.R. §1500.87(b); and discussion at 74 Fed. Reg. at 2440. 37 74 Fed. Reg. 2433 (Jan. 15, 2009). 38 Available at http://www.cpsc.gov/about/cpsia/101lead.pdf. 39 74 Fed. Reg. 10475 (March 11, 2009). 40 74 Fed. Reg. at 10476. 41 CPSIA §101(b)(1)(A). 42 The ballot vote and accompanying statements of Commissioners Nord and Moore with are available at http://www.cpsc.gov/library/foia/ballot/ballot09/atvexclusion.pdf. The ATV application and CPSC staff recommendation package is available at http://www.cpsc.gov/library/foia/foia09/brief/atvexclusion.pdf. 43 See the Commissioners‘ statements and directions to CPSC staff to develop elements of a stay-of-enforcement plan available at http://www.cpsc.gov/library/foia/ballot/ballot09/atvexclusion.pdf. 44 Id. 45 Id. 46 Id. 47 Letter available at http://www.learningresources.com/text/pdf/LR/SignOnLettertoActingChairmanNancy Nord4.9.09.pdf. See also Bureau of National Affairs, Nord „Open‟ to Granting Petition Request For Exclusion From Lead Rules, if Possible, 37 Product Safety Liability Reporter 412 (April 13, 2009). 48 Comments from American Honda Motor Co., Inc., et al., to the CPSC, dated Feb. 17, 2009, at 3 (citing letter from Sen. Klobuchar to the CPSC, dated Jan. 26, 2009), available at http://www.cpsc.gov/ library/foia/foia09/pubcom/leadexclusion.pdf. 49 597 F. Supp. 2d 370 (S.D.N.Y. 2009) [hereinafter NRDC lawsuit]. 50 Natural Resources Defense Council, Inc. and Public Citizen, Inc. 51 Advisory Opinion dated November 17, 2008, from CPSC General Counsel Falvey to Ms. Ravitz and B. Cohn, Arent Fox LLP, concerning the retroactive application of the phthalates ban of CPSIA §108 and of the lead content standard of CPSIA §101 [hereinafter CPSC Phthalates Opinion], available at http://www.cpsc.gov/ library/foia/advisory/320.pdf. 52 See Letter dated Nov. 24, 2008, from Senator Feinstein and Representatives Waxman, Schakowsky, and DeGette, to the CPSC Commissioners Nord and Moore, available at http://feinstein.senate index.cfm?FuseAction=NewsRoom.Home, and Letter dated Nov. 21, 2008 from Senator Boxer to CPSC General Counsel Falvey, available at http://boxer both urging that the General Counsel‘s interpretation be changed to apply the phthalates ban retroactively to inventory of noncompliant products. 53 For more information on the scientific studies regarding phthalates and human health effects, see CRS Report RL34572, Phthalates in Plastics and Possible Human Health Effects, by Linda-Jo Schierow and Margaret Mikyung Lee. 54 CPSIA §108(e) compared to Cal. Health & Safety Code §§108935-108939; 18 V.S.A. § 1511; Rev. Code Wash. (ARCW) §§ 70.240.010- 70.240.020. 55 OGC Advisory Opinion on applicability of the phthalates standard to wearing apparel, dated Nov. 25, 2008, available at http://www.cpsc.gov/library/foia/advisory/321.pdf, and OGC Advisory Opinion on applicability of the phthalates standard to shoes, dated Oct. 17, 2008, available at http://www.cpsc.gov/library/foia/advisory/318.pdf. 56 See information related to the CPSC public meeting on phthalates available at http://www.cpsc.gov/about/cpsia/phthalates.html. 57 74 Fed. Reg. 8058 (Feb. 23, 3009, available at http://www.cpsc.gov/businfo/frnotices/fr09/draftphthalatesguidance.pdf 58 Cal. Health & Safety Code §§108935-108939 (current on LexisNexis). 59 Cal. Health & Safety Code § 108935(a). 60 Cal. Health & Safety Code §108935(b).

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Consumer Product Safety Improvement Act (CPSIA): New Requirements and…

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61

161

Letter dated December 3, 2008, from Attorney General Brown, Supervising Deputy Attorney General Weil, and Deputy Attorney General Sullivan, State of California, to CPSC General Counsel Falvey, available at http://caag.state.ca.us/prop65/pdfs/CA_phthalate_letter.pdf. 62 Id. at 5. 63 Available at http://www.cpsc.gov/ABOUT/Cpsia/faq/preemption.html. 64 Susan Bohan, ―Phthalate ban in children‘s products now in force in California,‖ Contra Costa Times (January 1, 2009). 65 See petition package at http://www.cpsc.gov/about/cpsia/california.pdf. 66 ASTM International is the standards-setting organization formerly named American Society for Testing and Materials (ASTM). 67 CPSA §3(a)(10) (codified at 15 U.S.C. §2052(a)(11)). 68 CPSA §3(a)(10) (codified at 15 U.S.C. §2052(a)(11)). 69 Statements of Commissioners Nord and Moore accompanying the denial of an emergency stay of the effective date of lead limits under CPSIA §101(a)(2), available at http://www.cpsc.gov/library/foia/ballot/ballot09/nam.pdf. 70 See Executive Order 13272, ―Proper Consideration of Small Entities in Agency Rulemaking,‖ August 13, 2002 and §603 of the Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. § 603). On its website, the CPSC asserts that it ―fully considers the potential impact of its draft rules on small entities. The CPSC thoroughly reviews its draft rules to assess and take appropriate account of their potential impact on small businesses, small governmental jurisdictions, and small organizations. The CPSC ensures maximum notice to and participation by small entities in its rulemaking process.‖ This statement is available at http://www.cpsc.gov/ BUSINFO/smbusrm.html. 71 CPSC, Guide to the Consumer Product Safety Improvement Act (CPSIA) for Small Businesses, Resellers, Crafters and Charities, available at http://www.cpsc.gov/about/cpsia/smbus/sbguide.pdf. 72 Id. Also see, e.g., Lorie Zapf, Unintended Consequences of Toy Safety Bill, San Diego Business Journal On the Web (posted April 6, 2009) available at http://www.sdbj.com/article.asp?aID=99856415.854091 8.1765309.9471661 .7601674.481&aID2=135784; Thomas L. Gallagher, Manufacturers Urge Change in Product Safety Law, Journal of Commerce Online (posted April 3, 2009) available at http://www.joc.com/node/410562; commentary generally at http://amendthecpsia.com/category/in-the-news/. 73 State preemption petition packages for Arizona, California, Illinois, and New York, available at http://www.cpsc.gov/ABOUT/Cpsia/faq/preemption.html. 74 Letter from Sen. Rockefeller, Chairman of the Sen. Commerce, Science, and Transportation Comm., Rep. Waxman, Chairman of the House Energy and Commerce Comm., Rep. Rush, Chairman of the House Commerce, Trade, and Consumer Protection Subcomm., and Sen. Pryor, to the CPSC, dated Feb. 4, 2009 (urging a timeline for expeditious implementation of the CPSIA), available at http://energycommerce.house.gov/Press_111/20090205/cpsc.pdf; Letter from Rep. Dingell, Chairman Emeritus of the House Energy and Commerce Comm., to the CPSC, dated March 4, 2009, available at http://www.house.gov/apps/list/press (asking the CPSC to explain implementation issues); Letter from Sen. Durbin to Acting CPSC Chair Nord, dated March 27, 2009 (criticism of Acting CPSC Chair Nord‘s views and actions regarding implementation of the CPSIA) available at http://durbin.senate 75 Letter from Acting CPSC Chair Nord to Rep. Dingell, dated March 20, 2009, available at http://www.cpsc.gov/ about/cpsia/dingell032009.pdf, and Letter from Commissioner Moore to Rep. Dingell, dated March 20, 2009, available at http://www.cpsc.gov/about/cpsia/dingell032009a.pdf. 76 See supra note 72 for links to commentary and reporting on the April 1, 2009 rally reflecting the business constituency‘s frustration. 77 CPSIA Fact Sheet, available at http://www.citizen.org/print_article.cfm?ID=18326; Statement from a Coalition of Public Interest Organizations, dated Jan. 30, 2009, available at http://www.consumersunion.org/pub/core_product_safety 78 Id. 79 Letter to President Obama from the leaders of several consumer groups, dated Jan. 30, 2009, available at http://www.consumerfed.org/pdfs/CPSC_leadership 80 Letter from Rep. Joe Barton, ranking member of the House Energy and Commerce Comm., and Rep. Radanovich to Comm. Chairman Waxman, dated Jan. 21, 2009, available at http://www.scribd.com/doc/11063758/CPSIALetter-toHenry-Waxman. 81 Marcia Coyle, Consumer bill sets off furor, National Law Journal (April 13, 2009). 82 Letter from Sen. Rockefeller, Chairman of the Sen. Commerce, Science, and Transportation Comm., Rep. Waxman, Chairman of the House Energy and Commerce Comm., Rep. Rush, Chairman of the House Commerce, Trade, and Consumer Protection Subcomm., and Sen. Pryor, to Pres. Obama, dated Feb. 3, 2009, available at http://energycommerce.house.gov/Press_111/20090204/cpsc.pdf. 83 Statement of Acting CPSC Chair Nord, dated March 12, 2009, available at http:// www.cpsc.gov/pr/nord03122009appropriations.pdf.

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CHAPTER SOURCES

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The following chapters have been previously published: Chapter 1 – This is an edited, reformatted and augmented version of a United States Government Accountability Office publication, GAO-09-803, dated August 2009. Chapter 2 – This is an edited, reformatted and augmented version of a United States Congressional Research Service publication, Report Order Code RS22821, dated April 2, 2009. Chapter 3 – This is an edited, reformatted and augmented version of a United States Government Accountability Office publication, GAO-09-731, dated August 2009. Chapter 4 - This is an edited, reformatted and augmented version of a United States Congressional Research Service publication, Report Order Code RL34684, dated September 22, 2008. Chapter 5 – This is an edited, reformatted and augmented version of a United States Congressional Research Service publication, Report Order Code R40527, dated April 17, 2009.

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INDEX

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A AAP, 101 absorption, 91, 95, 182, 183, 184 academics, 75 accessibility, 142, 183 accidental, 112 accidents, 73, 74, 75, 110 accountability, 121, 126 accreditation, 71, 80, 143, 149, 180, 181, 192 acculturation, 116 accuracy, 116, 158, 159, 161 acute, x, 86, 113 adhesives, 79 administration, xi, 62, 63, 91, 92, 133 administrative, 5, 8, 23, 45, 62, 63, 77, 80, 91, 92, 133, 140, 151, 156, 189 Administrative Procedure Act (APA), 15, 143, 149 adult, 112, 172 adulterated food, 53 advertisement, 66, 68, 145 advertising, 127, 144, 169, 172, 178 advocacy, 62, 66, 72, 73, 185 African-American, 118, 130 age, 33, 80, 88, 90, 95, 97, 98, 99, 109, 110, 111, 112, 113, 116, 130, 144, 146, 169, 177, 178, 185, 186 agent, 23, 40, 45, 48, 51, 52 agriculture, 27 aid, 88, 164 air, 81 Alaskan Native, 146 alcohol, 7 alternative, 14, 29, 144, 186 ambiguity, 136

amendments, xi, 8, 133, 136, 143, 149, 150, 153, 154, 158, 165 American Indian, 106, 111, 116, 119, 130, 146 American Library Association, 90 analytic techniques, 126 Animal and Plant Health Inspection Service (APHIS), 3, 22, 25, 26, 27, 28, 43, 49, 53, 54, 55, 57, 59 animal health, 28 animals, 22, 26, 27, 43, 47, 49, 50, 53, 54, 55, 57, 59, 81 apparel, 4, 93, 98, 168, 184, 186, 193 apparel industries, 93 appendix, 30, 32, 60, 82, 124 application, 18, 24, 48, 52, 79, 81, 93, 100, 145, 152, 157, 170, 181, 184, 188, 193 appropriations, 5, 36, 78, 89, 96, 98, 146, 148, 150, 151, 166 Appropriations Committee, 89 aquaculture, 29 asbestos, 79, 170 asia, 34 asian, 3, 106, 116, 130, 146 Asia-Pacific Economic Cooperation (APEC), 3, 34 assessment, 17, 37, 38, 39, 67, 71, 74, 81, 96, 97, 98, 126, 161, 165, 166, 167 assessment procedures, 37 assets, 154 assumptions, 7, 78 ASTM, 145, 187, 188, 194 Atomic Energy Act, 136, 177 attachment, 192 attitudes, 122, 127 Attorney General, 186, 187, 194 auditing, 6, 29, 44, 106, 126 authorities, ix, 1, 2, 3, 5, 8, 12, 13, 14, 15, 17, 19, 21, 22, 23, 24, 29, 30, 31, 35, 38, 39, 40, 41, 42, 43,

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Index

46, 53, 55, 60, 65, 68, 71, 72, 74, 83, 135, 163, 165, 167, 172 automobiles, 7, 130 availability, 36, 70, 71, 95, 148 awareness, 28, 101, 127, 146, 160, 170

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B babies, 119 back, 27, 33, 81, 92, 147, 156, 171 barrier, 183, 193 battery, 91 behavior, 127 beliefs, 127 benefits, 84 bicycle accident, 110 bioterrorism, 25 bipartisan, 87 birth, 130 blog, 101 blood, 130 blood lead levels, 130 boats, 130, 136, 177 bonds, 20 border inspections, 27, 82 boxer, 193 boys, 113 broadcast media, 90, 105, 121 budget cuts, 107 budget resolution, 5 Bush Administration, 173 business education, 64

C campaigns, 106, 108, 119, 121, 122, 123, 146 Capitol Hill, 98 carbon, 169 carbon monoxide, 169 carcinogens, 186 caregivers, 112 cargo, 11, 27, 79 CCC, 3, 76, 77, 78, 84 cellulose, 172 Centers for Disease Control (CDC), 105, 108, 109, 111, 112, 114, 115, 116, 117, 126, 130, 131 ceramic, 170 certificate, 26, 47, 59, 80, 81, 112, 113, 116, 153, 178, 191, 192

chaos, 99 charcoal, 169 charitable organizations, x, 86, 90, 190 charities, xi, 86, 92, 93, 100 chemicals, 15 child care centers, 144 childhood, 108 chronic illness, 113 citizens, 69, 172 citizenship, 157 civil action, 155, 157, 159 classes, 98, 183 classification, 79, 123 Clean Air Act, 136, 177 clinics, 119 Coast Guard, 7 coatings, 181, 183 codes, 10, 18, 64, 77, 113 cohort, 51 collaboration, 34 commerce, 2, 9, 11, 17, 22, 25, 26, 36, 46, 47, 50, 54, 58, 78, 80, 81, 82, 135, 137, 145, 168, 179, 186, 192 Commerce Department, 87 Committee on Appropriations, 171 commodity, 183 common law, 89, 157 communication, 28 community, 11, 69, 118, 119, 121 compensation, 8, 151, 156 competition, 135, 192 compilation, 79 complement, 8 complexity, 15, 16, 65, 110 components, 2, 4, 91, 97, 104, 126, 136, 177, 183, 188, 193 composition, 70, 143 compounds, 79 computer systems, 53 confidence, 87, 114, 151 confidence interval, 114 confidentiality, 151, 158, 159 conflict, 188 conformity, 31, 37, 55, 71, 72, 81, 178, 179, 180, 191 confusion, 90, 91, 93, 176, 178 congress, iv, x, xi, 5, 19, 36, 81, 85, 86, 87, 89, 90, 91, 92, 93, 96, 97, 98, 99, 107, 133, 134, 141, 142, 147, 148, 151, 160, 172, 173 Congressional Budget Office, 172 consensus, 2, 8, 13, 29, 59, 126

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Index consent, 20, 22, 23, 30, 40, 44, 45, 58, 83, 84, 161, 167 constraints, 12, 19, 20, 30, 39, 79, 83, 127 construction, 143, 162 consulting, 37, 121 consumer education, ix, xi, 103, 106, 118, 123, 126 consumer goods, 4, 43, 76, 99 Consumer Product Safety Improvement Act, vii, ix, x, xi, xii, 1, 3, 5, 44, 78, 81, 85, 88, 90, 100, 101, 103, 105, 108, 133, 134, 142, 175, 176, 191, 194 consumer protection, 15, 16, 65, 73, 75, 86, 151, 154, 155, 166, 172 consumption, 78, 136, 177, 179, 192 control, 65, 74, 110, 172 corporations, 79 corrosive, 7 corruption, 88, 151 co-sleeping, 112 cosmetics, 7, 43, 59, 130, 136, 177 cost-benefit analysis, 152 cost-effective, 103, 123 costs, 15, 19, 20, 57, 75, 77, 82, 96, 97, 138, 156, 157, 164, 173, 179, 188 counsel, 155 counterfeit, 16, 76 country of origin, 51, 52, 130 Court of Appeals, 168 courts, 23, 44, 68, 157, 168 crimes, 151 crisis management, 75 criticism, 155, 173, 194 cross-border, 83 CRS, xii, 88, 134, 171, 175, 193 culture, 33, 121, 130 Customs and Border Protection (CBP), 2, 3, 5, 42, 137, 164, 166, 170 Customs Union, 69

D danger, 8, 63, 67, 68, 121 data collection, 103, 113, 117, 123, 130 data mining, 82 data set, 125 database, x, 82, 86, 88, 90, 108, 125, 149, 159, 160, 161, 166 DBP, 146, 185, 186 death rate, 104, 105, 111, 113, 116, 122, 126 decisions, 25, 27, 28, 38, 41, 53, 79, 90, 147, 155 defects, xi, 13, 68, 80, 133, 134, 140

167

deficiencies, xi, 133, 134 deficit, 191 definition, 63, 67, 70, 82, 98, 139, 163, 169, 171, 177 defraud, 154, 162 delivery, 135, 192 demographic characteristics, 122 demographics, 122 denial, 156, 183, 194 Department of Agriculture, 4, 6, 43, 44, 46 Department of Energy, 136, 177 Department of Health and Human Services, 6, 104, 105, 106, 108, 125, 128 Department of Homeland Security, 80, 170 Department of Housing and Urban Development, 171 Department of Justice, 7, 45, 83 Department of State, 6, 43, 82 Department of Transportation, 6, 7 destruction, 19, 20, 57, 71, 140, 164, 165, 167 detection, 53, 170 detention, 79 differential rates, 130 digital television, 126 directives, 71, 157, 173 disabilities, 109, 130 disclosure, 150, 158, 159, 161, 173 disposition, 109 disputes, xii, 175, 176 disseminate, 104, 118, 173 distribution, 8, 22, 30, 36, 38, 48, 52, 71, 142, 145, 147, 152, 153, 163, 179, 181, 182, 186 District of Columbia Circuit, 168 diversity, 24, 121, 157 division, 9, 31, 76 draft, 42, 44, 78, 124, 186, 194 drowning, 106, 108, 111, 112, 119, 122, 124, 125 drug manufacturers, 24 drugs, 7, 21, 24, 43, 47, 48, 50, 51, 53, 55, 59, 82, 113, 130, 136, 177 Due Process Clause, 45 duplication, 65 duration, 70, 127 duties, 7, 23, 40, 45, 146, 150

E education, 87, 124, 126, 127, 149 educational background, 121 egg, 22, 24, 26, 27, 43, 47, 50, 51, 52, 53, 54, 55, 59, 81, 82

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168

Index

elderly, 70, 135, 192 electroplating, 183 emergency departments, 160 emerging issues, 72 employees, ix, 5, 9, 19, 66, 85, 89, 91, 107, 140, 142, 146, 148, 149, 150, 151, 153, 155, 165, 172 employment, 151, 155, 156 empowered, x, 85, 92 enforcement, x, xi, xii, 2, 13, 15, 17, 19, 20, 23, 29, 31, 32, 34, 36, 39, 40, 44, 45, 61, 62, 64, 65, 68, 69, 71, 74, 77, 82, 86, 89, 91, 92, 99, 100, 133, 134, 135, 136, 140, 147, 151, 154, 155, 160, 162, 166, 168, 169, 172, 175, 176, 180, 181, 184, 188, 193 engagement, 2, 32, 33, 34, 39, 64 enrollment, 119 entrepreneurs, 102 environment, 27 Environmental Protection Agency, 7, 136, 177 estimating, 20, 114, 117 ethical issues, 150 ethics, 151 ethnic groups, 104, 112, 116, 124 ethnic minority, 108 ethnicity, 104, 108, 109, 110, 111, 113, 114, 115, 116, 117, 123, 125, 130, 131 European Commission, 3, 31, 33, 69, 83 European Parliament, 84 European Union, 3, 6, 43, 44, 60, 69, 141 examinations, 26 exclusion, 100, 182, 184 Executive Order, 157, 173, 194 exercise, 41, 45, 92, 140 expertise, 8, 70 exporter, 76 exports, 30, 75, 153 exposure, 36, 97, 98, 105, 111, 121, 122, 142, 181, 183

F fabric, 86, 100, 135, 183, 192, 193 failure, 57, 80, 83, 137, 139, 153, 162, 163, 172 faith, 100, 149, 156 family, 99, 100, 190, 191 FDA, 2, 3, 6, 7, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 38, 39, 40, 43, 46, 47, 48, 49, 51, 52, 53, 55, 56, 58, 59, 81, 82, 173 fear, x, 86, 91, 92, 94 federal courts, 157

federal government, 62, 65, 130 Federal Hazardous Substances Act, 7, 47, 87, 135, 179, 192 federal law, 89, 151, 154, 172, 185, 187 Federal Railroad Administration, 83 Federal Register, 90, 157, 159, 168, 183, 184 Federal Trade Commission (FTC), 135, 149, 192 Federal Trade Commission Act, 135, 192 feedback, 121 feeding, 146, 185, 186 fees, 156, 157 fiber, 183 film, 181 finance, 108 Financial Services and General Government, 98 fines, x, 65, 68, 75, 76, 79, 86, 91, 154 fire, 81, 110, 119 firearms, 7, 136, 170, 173, 177 firms, 29, 87, 90, 94, 97, 99 flammability, 7, 86, 135, 139, 157, 192 Flammable Fabrics Act, 7, 47, 87, 135, 139, 157, 179, 192 flexibility, 91, 92, 97, 160 flotation, 7 flow, 79, 162 focus group, 121 focusing, xii, 14, 16, 175, 176 FOIA, 101, 158, 161 food, 7, 18, 21, 24, 25, 26, 28, 29, 34, 43, 48, 50, 51, 52, 53, 54, 55, 57, 59, 65, 66, 72, 75, 76, 136, 170, 177 Food and Drug Administration (FDA), 3, 6, 43, 44, 46, 87, 136, 149, 173, 177 food products, 66 food safety, 24, 26, 28, 29, 53, 72 forfeiture, 154 Forfeiture Fund, 20 formaldehyde, 168 Fourteenth Amendment, 45 fraud, 150 Freedom of Information Act (FOIA), 158 frustration, 194 funding, xi, 5, 19, 20, 37, 72, 89, 94, 95, 96, 98, 107, 122, 134, 142, 146, 147, 148, 171 furniture, 141, 170, 181

G games, 144, 183 gas, 66, 169

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Index gasoline, 7, 141, 173 gender, 109, 110, 113 generators, 169 gift, 93 global supply chain, 65 goals, 2, 15, 35, 36, 38, 41, 93, 94, 104, 106, 109, 118, 121, 127 good faith, 149 Government Accountability Office (GAO), 1, 100, 103, 145, 197 Government Performance and Results Act, 6, 38, 40, 44 government-to-government, 29 grants, 72, 185 gravity, 154 groups, ix, xi, 8, 15, 33, 37, 62, 66, 72, 73, 80, 89, 97, 103, 104, 105, 106, 108, 110, 112, 116, 119, 120, 121, 123, 126, 127, 130, 141, 150, 171, 173, 184, 185, 194 growth, 38, 79 guidance, x, 6, 44, 59, 77, 82, 86, 90, 92, 93, 104, 115, 118, 140, 183, 186, 190 guidelines, 17, 18, 66, 135, 164, 172, 176, 180, 181, 185, 189, 192 guns, 170

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H handicapped, 135, 192 handling, 7, 69, 135, 163, 192 harm, 8, 30, 31, 36, 58, 72, 84, 108, 160, 161 harmonization, 141 hazardous substance, 135, 137, 138, 139, 140, 153, 155, 192 hazards, xi, 7, 13, 62, 63, 97, 104, 107, 109, 121, 123, 130, 133, 134, 135, 165, 168, 170, 192 health, ix, x, xi, 16, 18, 25, 27, 28, 41, 55, 65, 67, 68, 70, 72, 74, 77, 82, 86, 88, 94, 95, 98, 103, 105, 106, 108, 116, 117, 119, 125, 130, 146, 151, 158, 159, 160, 161, 163, 182, 193 Health and Human Services (HHS), 6, 42, 87, 104, 105, 106, 108, 111, 116, 117, 119, 123, 124, 125, 126, 128, 149 health care, 105, 108, 116, 125, 160 health care professionals, 160 health clinics, 119 health effects, 130, 193 health information, 27 health insurance, 130 health services, 108

169

hearing, 80, 137, 138, 139, 156, 163, 182 helmets, 169 hiring, 190 HIS, 82 hispanic, 106, 112, 116, 118, 121, 129, 130, 131, 146 Homeland Security, 80, 170 Homeland Security Act, 170 hospital, 104, 109, 113, 115, 116, 130 host, 90 hotels, 144 house, xi, 4, 68, 86, 89, 94, 99, 100, 101, 124, 125, 133, 141, 162, 168, 169, 170, 171, 194 household, 4, 7, 74, 78, 86, 87, 98, 108, 113, 117, 125, 135, 136, 176, 192 Housing and Urban Development, 171 HTS, 10, 80 human, 59, 67, 68, 77, 91, 182, 183, 184, 186, 193

I identification, 80, 164, 168 identity, 112 images, 101 immigration, 81 Immigration and Customs Enforcement, 80 imported products, ix, x, 1, 3, 5, 9, 10, 12, 16, 17, 18, 26, 30, 31, 35, 37, 39, 43, 67, 72, 75, 82, 83, 85, 87, 89, 139, 140, 168, 171 importer, 10, 17, 23, 51, 55, 56, 72, 74, 76, 80, 140, 144, 178, 179, 181, 191 imports, 4, 11, 12, 16, 18, 21, 23, 25, 29, 32, 39, 43, 47, 57, 75, 79, 134, 139, 167, 188 imprisonment, 75, 154 incentive, 15 incidence, xi, 103, 106, 111, 112, 123, 125, 145 inclusion, 161 income, 105, 112, 119 independence, 180 Independent Agencies, 171 Indian, 105, 106, 108, 111, 116, 119, 126, 130, 146 Indian Health Service (IHS), 105, 108, 126 indication, 70 industrial, 31, 69, 71 industry, 5, 8, 12, 13, 14, 15, 25, 31, 39, 40, 42, 44, 64, 67, 71, 76, 80, 87, 88, 89, 90, 91, 95, 96, 98, 101, 119, 142, 150, 158, 173, 184, 187 infants, 111, 112 inflation, 89, 154, 172 information exchange, 34, 83 information sharing, 2, 17, 18, 33, 40

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Index

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Information System, 3, 4, 27, 82 information technology, 2, 25, 27, 149, 160, 161 infrastructure, 27, 190 ingestion, 97 injunction, 140, 154 insight, 88 Inspector General, 149, 150, 172 inspectors, 20, 26, 28, 29, 68, 77, 87, 148 institutions, 44 instruction, 112 insulation, 172, 180 insurance, 130, 164 integration, 160 intelligence, 82 interaction, 5, 42 Internal Revenue Service, 38 international standards, 76 International Trade, 3, 9, 11, 12, 18, 20, 37, 81, 82, 166 International Trade Commission, 12 Internet, 107, 121, 127, 129, 144 interstate, 47, 78, 135, 145, 192 interstate commerce, 47, 78, 135, 145, 192 intervention, 36, 40, 46, 83, 84, 94 interviews, 6, 17, 23, 43, 44, 60, 117, 121 inventories, 15, 93 Investigations, 9, 125, 131, 151 investment, 19

law enforcement, 64, 151 lawsuits, 15, 76, 181 lawyers, 111 lead content, xii, 91, 92, 100, 113, 141, 170, 175, 176, 180, 181, 182, 183, 184, 192, 193 leadership, x, 85, 94, 108, 116, 194 legislation, x, xi, 34, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 85, 87, 99, 101, 108, 133, 134, 142, 145, 147, 170, 184, 189, 190 legislative proposals, 176 librarians, 98 licenses, 77 lien, 57, 140 likelihood, 104, 123 limitations, 14, 35, 64, 104, 122, 148 linguistically, 116 links, 27, 36, 53, 194 litigation, 83, 155, 156 livestock, 55, 57 living conditions, 105 local authorities, 74 local government, 74, 155, 172, 187 location, 109, 112 logistics, 168, 169 losses, 96, 99 low risk, 181 low-income, 105, 119

M

J Japanese, 31, 73, 74, 75 jewelry, 97, 113, 143, 180, 192 judge, 80 judgment, 15, 168, 189 jurisdiction, 7, 11, 12, 18, 22, 23, 24, 25, 30, 39, 40, 43, 44, 45, 58, 66, 74, 81, 82, 83, 84, 93, 107, 108, 109, 129, 136, 138, 139, 140, 141, 148, 152, 156, 162, 168, 170, 177, 190, 191

L labeling, 8, 51, 57, 70, 74, 78, 135, 139, 143, 172, 192 language, 33, 84, 116, 118, 121, 131, 145, 150, 162, 169, 173, 184 large-scale, 188 Latin America, 28 Latino, 130

machinery, 71 magnets, 69 maintenance, 70, 173 males, 112 management, 28, 75, 80, 126 management practices, 80 mandates, xi, 7, 38, 53, 58, 134, 135, 142 manufactured goods, 76 manufacturing, 9, 19, 20, 22, 29, 36, 38, 39, 50, 51, 55, 74, 77, 78, 80, 99, 144, 152, 155, 167, 168, 188 market, 8, 23, 30, 32, 33, 34, 49, 59, 64, 67, 71, 72, 79, 80, 82, 83, 84, 88, 99, 127 marketplace, 15, 36, 38, 39, 41, 64, 67, 93 measures, 5, 13, 29, 38, 41, 42, 68, 71, 74, 83, 87, 118, 122, 161 meat, 22, 24, 26, 27, 43, 47, 48, 50, 51, 52, 53, 54, 55, 57, 59, 81, 82, 101 media, 90, 105, 106, 107, 118, 121, 127, 148 Medicaid, 129

Consumer Product Safety Commission Issues, Nova Science Publishers, Incorporated, 2010. ProQuest Ebook Central,

Index medical care, 115 memorandum of understanding (MOU), 3, 16, 17, 18, 25, 78, 81, 166 merchandise, 18, 79 messages, 104, 106, 119, 121, 122, 123, 127 messengers, 106, 127 metals, 183 metric, 14 Middle East, 28, 82 mining, 82 minority, ix, xi, 103, 104, 105, 106, 108, 118, 120, 123, 125, 126, 130, 146 minority groups, 105, 108, 119, 123, 130 misleading, 69 missions, 27 misunderstanding, 178 modernization, 166 money, 19, 20, 68, 89, 101, 146 mortality, 110, 112, 125 motels, 144 motorcycles, 90, 91, 95, 184 mouth, 185, 186 movement, 86 MRA, 172 multilateral, 2, 24, 29, 32, 35, 42, 83 multiple factors, 82

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N NAM, 92, 98, 101, 102 nanotechnology, 170 nation, 34, 87, 91 National Academy of Sciences, 116, 130 National Association of Manufacturers, x, 86, 87, 90 National Health Interview Survey, 117, 125 National Highway Traffic Safety Administration (NHTSA), 3, 6, 21, 22, 23, 26, 43, 46, 47, 48, 49, 50, 51, 52, 53, 55, 56, 57, 58, 81 National Hospital Discharge Survey, 125 National Institutes of Health, 108, 111, 123, 126 national product, 65, 89 nationality, 130 Native Hawaiian, 106, 130, 146 natural, 111, 183 negotiating, 68, 130, 141 nongovernmental, 63 nongovernmental organization, 63 non-profit, xii, 175, 190 normal, 26, 70, 152, 182, 183 Nuclear Regulatory Commission, 136, 177

171

O obligation, 71, 72 observations, 49, 157 Occupational Safety and Health Act, 136, 177 Office of Management and Budget, 96, 130, 148 Office of the United States Trade Representative, 4, 5, 42 omnibus, 89, 96 online, 108, 119, 121, 172 oral, 113 Organization for Economic Cooperation and Development (OECD), 3, 6, 30, 31, 32, 34, 37, 44, 82, 83 outreach programs, 23, 45 oversight, 77, 87, 89, 94, 150

P Pacific, 3, 34, 106, 116, 130, 146 packaging, 7, 51, 70, 86, 88, 135, 143, 144, 152, 169, 178, 192 parents, 105, 112, 119, 172 Parliament, 84 partnerships, 122 passive, 163 patients, 113, 115, 116 peer, 148, 182 penalties, 5, 10, 45, 65, 68, 75, 76, 79, 83, 91, 100, 141, 154, 162, 176 periodic, 14, 19, 48, 80, 142, 143, 181 permit, 23, 48, 49, 137, 143, 158, 167, 188 persons with disabilities, 130 pesticides, 7, 82, 136, 177 pests, 50, 54 pharmaceuticals, 173 phthalates, xii, 15, 88, 90, 92, 95, 97, 98, 134, 146, 171, 175, 176, 180, 181, 185, 186, 187, 188, 190, 193 physicians, 111, 160 planning, ix, 1, 6, 35, 37, 41, 44, 126 plants, 19, 20, 22, 26, 27, 29, 39, 43, 47, 49, 50, 53, 54, 59, 75, 78, 81, 167 plastic, 183 play, 70, 108, 144, 186 poison control centers, 110 poisoning, 106, 110, 111, 112, 113, 119, 122, 125, 169 police, 160

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172

Index

pools, 106, 111, 112, 113, 130, 141, 146, 186 poor, 66, 105, 116 population, 122 port of entry, 5, 17, 19, 42, 52, 53, 55 ports, 2, 9, 10, 11, 12, 13, 16, 17, 18, 19, 22, 26, 27, 28, 36, 38, 39, 41, 49, 52, 53, 54, 55, 80, 81, 141, 148, 166 postmortem, 59 poultry, 22, 24, 26, 27, 43, 47, 48, 50, 51, 52, 53, 54, 55, 57, 59, 81, 82 poverty, 105 power, 31, 64, 65, 83, 89, 91, 135, 155, 169 precedents, 185 predictability, 37 prescription drugs, 113 president, 98 press, 73, 88, 90, 101, 121, 126, 194 pressure, 2, 11, 71, 80 prevention, 36, 39, 40, 46, 84, 87, 105, 106, 108, 110, 119, 120, 122, 126, 146, 173 preventive approach, 39 Privacy Protection Act, 172 private, 8, 13, 36, 72, 79, 81, 89, 110, 116, 130, 143, 144, 155, 158, 160, 161, 172, 178, 181 private sector, 36, 89, 155 proactive, 72, 83 probability, 160 probe, 193 producers, 31, 83 product design, 146, 169, 177, 185 production, 21, 144, 148, 188 professionalism, 93 profit, xii, 175, 190 program, 7, 9, 13, 16, 21, 22, 24, 27, 35, 48, 53, 80, 81, 82, 97, 108, 119, 122, 137, 161, 178, 179 progress reports, 165 propagation, 52 property, iv, 77 protection, 15, 16, 65, 69, 70, 73, 75, 79, 86, 135, 142, 143, 145, 151, 155, 166, 172, 184, 186, 192 PSA, 167 public awareness, 101, 160, 170 public health, 27, 82, 88, 94, 108, 119, 158, 159, 182 public interest, 135, 138, 139, 151, 160, 161, 163 public notice, 88, 107, 108, 137, 138, 162, 163, 165 public safety, 149, 160, 161, 188 public service, 119 publishers, 90, 98

Q quality control, 74 quarantine, 56 questionnaire, 44, 82 quorum, 147, 148

R race, 104, 108, 109, 110, 111, 113, 114, 115, 116, 117, 123, 125, 130, 131 radiation, 59, 86, 136, 177 radio, 104, 107, 118, 162 radio station, 118 rain, 81 random, 64 range, xii, 3, 5, 20, 31, 39, 62, 64, 77, 83, 87, 88, 96, 99, 111, 113, 135, 141, 161, 175, 176 reading, 142, 182 real terms, 89 recall, ix, xii, 4, 50, 63, 64, 65, 68, 71, 77, 108, 118, 121, 130, 134, 136, 138, 139, 140, 141, 144, 151, 152, 153, 158, 160, 163, 164, 165, 171 recall information, 158 reciprocity, 151 recognition, 25, 37 reconcile, xi, 133, 142 recreation, 105, 107, 129, 136, 177 re-export, 153, 192 Reform Act, 171, 172, 179 reforms, 65 regional, 9, 28, 141 regular, 32 regulators, 29, 34, 91 Regulatory Commission, 136, 177 regulatory framework, 176 regulatory requirements, 25 reimbursement, 57, 138, 140, 150, 151, 171 relationship, 16, 17, 19, 37, 81 relaxation, 186 reliability, 125 repair, 71, 100, 107, 138, 163 reproductive toxicant, 186 reputation, 75 Research and Development, 136, 177 research design, 126 residues, 29 resolution, 5

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Index resources, ix, x, xi, 1, 2, 3, 4, 14, 19, 20, 21, 24, 25, 26, 27, 28, 32, 35, 36, 38, 40, 41, 62, 64, 69, 85, 94, 95, 97, 98, 106, 121, 122, 127, 133, 134, 141, 150, 167, 190 responsibilities, xi, 2, 7, 9, 10, 11, 17, 31, 35, 37, 70, 84, 86, 89, 92, 94, 127, 137, 139, 149, 167 restructuring, 147 retail, 15, 91 retaliation, 155, 156 RFA, 194 risk assessment, 17, 38, 39, 67, 81, 96, 165, 166, 167 risk management, 28, 80 rolling, 178 rubber, 183 rural, 105, 119

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S safeguard, 77, 161 salaries, 140 sales, 78, 96, 100, 141, 179, 181 sample, 10, 26, 36, 82, 104, 109, 114, 160 sanctions, 32 satisfaction, 122, 126 scheduling, 48 school, 107, 129, 136, 176 seafood, 82 search, 126 secret, 158, 161 Secretary of Agriculture, 57 Secretary of Commerce, 149 Secretary of the Treasury, 10, 170 Secretary of Transportation, 21 security, 164 seizure, 55, 79, 80, 140 self-regulation, 16 self-report, 116, 117 seller, 152 Senate, xi, 4, 67, 68, 86, 89, 94, 99, 102, 124, 133, 141, 147, 159, 169, 171, 172, 173, 179, 184, 191, 193, 194 Senate approval, 67 series, x, 79, 85, 86, 89, 141, 154, 172 service provider, 160 services, iv, 100, 108, 122, 172 severity, 109 sharing, 2, 17, 18, 32, 33, 34, 37, 39, 40, 65, 112, 117, 155, 166 shelter, 162 shipping, 17, 27, 75

173

short-term, 35, 36, 38, 40 SIDS, 118 SIS, 22, 25 sites, 44, 61, 74 sleep, 112, 118, 146, 185, 186 small businesses, x, xii, 86, 90, 92, 93, 100, 154, 175, 176, 188, 189, 190, 194 small firms, 97 smoke, 170 socioeconomic, 116, 117, 123 socioeconomic status, 117, 123 specificity, 113 speed, 17, 95 spelling, 93 sports, 107, 129 stability, 8 staffing, 5, 89, 95, 107, 172 stakeholder, 118, 127 standard operating procedures, 37 state laws, 87, 146, 155, 157, 171, 176, 185, 186, 187 state office, 155 statistics, 125, 165 statutory provisions, 139 stay of enforcement, ix, 14, 41, 176, 178, 180, 181, 184, 192 stock, 164 stockpiling, 152, 172 storage, 140, 179 strategies, 9, 122 subsistence, 140, 146 substances, 7, 66, 78, 84, 86, 113, 135, 137, 153, 160, 186, 192 sudden infant death syndrome, 118 suffering, 30 summaries, 44 supervision, 112, 140 supplements, 110, 113 suppliers, 15, 34, 64, 66, 68 supply, 21, 40, 45, 62, 65, 83 supply chain, 21, 40, 45, 65 support staff, 20, 38 Supreme Court, 168, 173 surveillance, 2, 5, 9, 11, 13, 16, 18, 19, 21, 22, 25, 26, 27, 28, 32, 34, 36, 38, 39, 41, 42, 53, 71, 80, 82, 83, 84, 137, 160 swallowing, 182, 183 syndrome, 118 systems, 2, 9, 16, 17, 25, 27, 28, 38, 53, 82, 113, 116, 130, 160, 161, 170

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174

Index

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T targets, 28 Tariff Act, 55, 79, 139, 166 tariffs, 75 technical assistance, 28, 117 technology, 2, 25, 27, 67, 149, 160, 161, 170, 190 telemarketing, 172 telephone, 104, 107, 118, 172 television, 104, 107, 118, 122, 126, 162 television stations, 107 temperature, 59 term plans, 2, 35, 36, 38, 40 terminals, 91 territory, 27, 45, 57, 61, 62, 63, 64, 65, 78, 79, 83, 84 testimony, 54, 148 testing, ix, x, xii, 5, 10, 13, 14, 15, 17, 19, 22, 24, 30, 31, 32, 39, 41, 42, 47, 48, 55, 56, 72, 75, 76, 78, 80, 81, 86, 88, 91, 92, 93, 95, 97, 99, 100, 137, 141, 143, 149, 153, 158, 171, 175, 176, 178, 179, 180, 181, 188, 191, 192 textiles, 168 third party, 10, 48, 80, 81, 95 threat, 8, 55, 74, 91, 188 threshold, 173 time, 5, 8, 9, 11, 14, 19, 36, 40, 45, 55, 59, 64, 67, 74, 75, 79, 80, 81, 96, 99, 107, 116, 148, 151, 158, 159, 171, 172, 184, 187, 190 time constraints, 79 time frame, 81 title, 169, 171, 173, 178 Title III, 78, 147 tobacco, 7, 136, 177 tort, 8, 15, 151, 157, 173 toxic, 7, 186 toys, ix, x, xi, 4, 13, 23, 24, 25, 33, 34, 69, 71, 80, 81, 83, 85, 88, 106, 113, 130, 133, 134, 141, 144, 145, 146, 170, 176, 185, 186, 187 tracking, 69, 81, 98, 144, 153 trade, x, 9, 11, 16, 20, 24, 34, 37, 51, 76, 80, 81, 86, 90, 91, 158, 161, 192 Trade Act, 37, 62 trade agreement, 24, 37 Trade Representative, 4, 5, 9, 24, 42 trade-off, 16 trading, 62, 63, 76 training, 17, 28, 33, 36, 148, 151

training programs, 17 transfer, 83 transition, 99, 126 transmits, 83 transparent, 32 transport, 22 transportation, 81, 135, 192 trauma, 109 travel, 77, 88, 140, 142, 146, 150 treasury, 10, 20, 62, 63, 170

U U.S. Department of Agriculture (USDA), 2, 4, 6, 20, 21, 22, 26, 27, 28, 40, 43, 46, 51, 58, 59, 81, 82 U.S. Department of the Treasury, 20 uncertainty, xii, 15, 175, 176 uniform, 9, 76, 87, 107 Uruguay Round, 82 US Consumer Product Safety Commission, 130

V validity, 159 values, 30 vehicles, 7, 21, 22, 23, 43, 47, 50, 51, 55, 57, 88, 95, 97, 100, 130, 136, 142, 168, 171, 177, 184, 191 vessels, 136, 177 victims, 112 Vietnamese, 33 violence, 109 voicing, 89, 93

W warehousing, 179 water, 111 wearing apparel, 193 websites, 144 whites, 112 wholesale, 15 withdrawal, 71 witnesses, 89 working groups, 33 World Trade Organization, 4, 24, 37 writing, 94, 122, 156, 163 wrongdoing, 8

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