The Toxic Substances Control Act

1017 Pages·2010·3.891 MB·English

by  Miriam V. Gold, Jean Warshaw

The Toxic Substances
Control Act
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The Toxic Substances
Control Act
A Practical Guide
Miriam V. Gold and Jean Warshaw
1

2010
1

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All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or
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_____________________________________________
Library of Congress Cataloging-in-Publication Data
Gold, Miriam V.
The Toxic Substances Control Act: A Practical Guide / Miriam V. Gold, Jean Warshaw.
p. cm.
Includes bibliographical references and index.
ISBN 978-0-19-538862-6 (pbk. : includes cd : alk. paper)
1. United States. Toxic Substances Control Act. 2. Chemicals—Law and legislation—United States.
3. Poisons—Law and legislation—United States. 4. Hazardous substances—Law and legislation—United
States. I. Warshaw, Jean. II. Title.
KF3958.G65 2010
344.7304’622—dc22
2010001390
_____________________________________________
1 2 3 4 5 6 7 8 9
Printed in the United States of America on acid-free paper
Notice to Readers
This publication is designed to provide accurate information with respect to the subject matter covered. It is
based upon sources believed to be accurate and reliable and is intended to be current as of the time it was
written. To confi rm that that the information herein has not been affected or changed by recent developments,
legal research should be undertaken, including review of primary sources as required. The reader should not
rely on this publication to address specifi c questions that apply to a particular set of facts. The authors and
publishers make no representation or warranty, express or implied, as to the completeness or correctness of
the information contained herein. In addition, the authors and the publisher assume no liability of any kind
resulting from the use of, or reliance on, the contents of this book. This publication is sold with the
understanding that neither the authors nor the publisher is providing legal advice on any specifi c matter. If
legal advice is required, a lawyer should be engaged to render advice on the specifi c matter at issue, after a
careful review of all of the relevant facts.
(Based on the Declaration of Principles jointly adopted by a Committee of the American Bar
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You may order this or any other Oxford University Press publication by
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Th is book is dedicated to:
our parents, Sam and Ruth Vogel and Irv and Th elma Laifer;
our spouses, Bob Michel and Tom Gold; and
our children, Josh, Danny, Noah, and Claire
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Preface
Th e genesis of this treatise began when the two authors started to work
together at Ciba-Geigy Corporation. For Miriam, the genesis occurred in the
mid 1990s when she took a position as Vice President of Legal and Regulatory
Aff airs at a company division which later became a part of Ciba Specialty
Chemicals Corporation. Th at job required more than just advising clients on
the law and telling them to comply with those requirements. It included oper-
ational responsibility for compliance. She discovered that compliance best
happens when legal requirements are seamlessly integrated into day to day
business operations, eliminating extra steps and additional thought and work.
Making it easy for people to meet regulatory requirements made compliance
sustainable. Th at involved both a sea change in how regulatory people did
their jobs, substituting transparency and teamwork for control, and how they
were perceived by employees in the rest of the business. As that transforma-
tion began to occur, something unexpected and competitively advantageous
happened. Compliance and role changes led to getting products to market
consistently quicker and less expensively.
For Jean, the route to this sea change began in the late 1980s when she
began practicing environmental law at a time when there was a constant
stream of major new environmental regulations. As each new regulation
came into eff ect the businesses needed guidance to understand the implica-
tions and integrate new practices on a continual basis. Environmental laws
are oft en criticized for being medium specifi c instead of industry specifi c, and
the challenge of bringing together all of the governing rules for the many
businesses she counseled lead to the realization that each business needs to
have a sustainable system for compliance that is built into the every day work
procedures.
Miriam and Jean worked together as a team to integrate compliance with
the Toxic Substances Control Act into the work processes of the businesses.
Th ey benefi tted greatly in implementing this task by the ISO and team culture
of the businesses, and succeeded with the assistance and enthusiasm of the
people in those businesses. You know who you are—and we thank you all for
your support.
viii Preface
H aving succeeded in implementing a sustainable compliance system, we
decided that we should share what we learned with others, and that is what
makes this book unique among other books on TSCA. We are passing along
to our readers the benefi ts of many years in the trenches and the wisdom of
our successes, as well as the lessons from our failures. It took longer than
perhaps we thought it would to put this treatise together—even longer than
the project we originally implemented. Along the way we have had help from
colleagues, and we would like especially to thank Tom Mesevage who wrote
the fi rst draft s of Chapters 7 and 11. Our husbands, Tom Gold and Bob
Michel, off ered their unwavering support and encouragement, especially as
the deadline for turning in our manuscript got closer and closer and we spent
more and more time with one another, instead of them, rehashing, updating,
and correcting our work. We also thank David Balutanski, Lynne Rosenberg,
Jen Nevergole and Maddalena Nappi Reidy for helping to pull the resources
and manuscript together.
Th anks to Matt Gallaway, our editor, and the rest of the team at Oxford
University Press for their guidance and for making this entire project a
reality.
Th anks also to HeinOnline for granting permission to reproduce Federal
Register notices from their service on the accompanying CD.
Contents
CHAPTER 1 Introduction 1
I. What is TSCA 2
II. History of TSCA 3
III. TSCA’s Future 4
IV. How to Use this Book and Accompanying CD 7
CHAPTER 2 TSCA’s Scope 9
I. Chemical Substances Subject to TSCA 10
A. Commercial Chemicals 10
B. Impurities 12
C. Byproducts 13
D. Isolated Intermediates 14
E. Chemicals Manufactured for Export Only 17
F. Research & Development Chemicals 20
G. Nanomaterials 20
1. Background on Nanomaterials and Nanotechnology 21
2. TSCA Status of Nanomaterials 22
I I. Chemical Substances and Materials Not Subject to TSCA 28
A. Mixtures 28
B. Pesticides 34
C. Nuclear Material 39
D. Firearms 40
E. Foods, Drugs, and Cosmetics 41
F. Articles 43
III. Activities Governed by TSCA 46
A. Use and Process 47
B. Manufacture and Toll Manufacture 49
C. Importation 50
D. Manufacture or Distribution in Commerce 50
IV. TSCA’s Interrelationship with Other Laws 51
A. Resource Conservation and Recovery Act 51
B. Federal Food, Drug, and Cosmetic Act 52
C. Tort Law 52
D. Others 53