handbook of chemical industry labeling

HANDBOOK OF CHEMICAL INDUSTRY LABELING Edited by Charles J. O'Connor Labeling and Hazard Analysis Consultant Greens Farms, Connecticut Sidney 1. Lirtzman Baruch College City University of New York New York, New York NOY ES PUBLICATIONS Park Ridge, New Jersey, USA Copyright 01984 by Noyes Publications No part of this book may be reproduced in any form without permission in writing from the Publisher. Library of Congrerr Catalog Card Number: 83-22108 ISBN 0-8155-09a4 Published in the United States of America by Noyes Publications Mill Road, Park Ridge, New Jersey 07656 1098765 Library of Congress Cataloging in Publication Data Main entry under title: Handbook of chemical industry labeling. Includes bibliographies and index. 1. Chemicals- -Labeling- -Law and legislation- -United States. 2. Products liability- -Chemical products- - United States. 3. Chemicals- - Labeling- -United States. 1. O'Connor, Charles J. KF3958.H36 1984 344.73'0424 83-22108 ISBN 081!j6.0966-0 347.304424 Contributors Adria C. Casey Stauffer Chemical Company Westport, CT Harry Fund Labelmaster Chicago, IL Anthony J. Gmo The City College of New York and the Mount Sinai School of Medicine New York, New York John E. Gillick Kirby, Gillick, Schwartz and Tuohey, P.C. Washington, D.C. Steven D. Jellinek Jellinek Associates, Inc. Washington, D.C. Sidney I. Lirtzman Graduate School and University Center and Baruch College City University of New York New York, NY Jennifer Machlin Orrick, Herrington and Sutcliffe San Francisco, CA Donald G. MacKellar Toxigenics, Inc. Decatur, IL Richard Moriarty National Poison Center Children’s Hospital Pittsburgh, PA Charles J. O’Connor Labeling and Hazard Analysis Greens Farms, CT Flo H. Ryer U.S. Environmental Protection Agency Washington, D.C. Consultant Norma Skolnik International Playtex, Inc. Paramus, N.J. Robert M. Sussman Covington and Burling Washington, DC James Toupin Covington and Burling Washington, DC xi xii Contributors Jay A. Young Consultant Silver Spring, MD David F. Zoll Chemical Manufacturers Association Washington, D.C. Contents PREFACE v CONTRIBUTORS xi PART I LABEL COMMUNICATION 1 . LABELS, PERCEPTION AND PSYCHOMETRICS 5 Functions of Labeling 5 Background 5 Definition 6 Purpose of Labeling 6 Views About Labeling 8 Sidney Z . Lirtzman Hazard Labeling 9 Perceptual Issues in Labeling 10 Perception 10 Perceptual Representation 10 Attention Processes 12 Form 13 Color 13 Color Preferences 14 Color and Emotion 16 Color Visibility 18 Color and Hazard Labeling 18 Legibility 19 Symbols and Labeling 20 Advantages of Graphic Symbols in Labeling 23 Disadvantages of Graphic Symbols 23 Reading Level of Label 25 Estimating Reading Level 26 Evaluating the Impact of Labeling 27 Evaluation Criteria 27 xiii xiv Contents Implications for Hazard Labeling 28 TestingMetho ds 29 Tachistoscopic Procedures 29 Eye Motion and Pupilometrics Equipment 30 Research in Hazard Labeling 31 Attitudes About Hazard Warnings on Labels 31 Food Labeling 31 FDA and DHEW Research 31 Drugs 32 Pesticides 32 Children and Hazard Labels 32 Hazardwarnings 33 Improving Label Effectiveness 36 References 38 Additional Suggested Readings 39 2 . INFORMATION SOURCES AND SYSTEMS FOR LABELING 41 Introduction 41 Regulatory Information 41 Government Documents 41 Computerized Data Systems 44 Access to Government Documents 45 Scientific Literature 46 Self Services 46 Private On-Line Services 50 Search Services-Types and Costs 54 Government Literature Retrieval Systems 56 References 61 3 . TRANSPORTATION LABELS AND PLACARDS: TECHNOLOGY 63 Introduction 63 Label Technology 66 Labels Other than DOT 71 Markings 72 Placards 72 Placard Technology 73 The Technical Aspects of Label Production -79 Choosing the Label Material 79 Methods for Printing Labels 81 Planning A Label Program 83 Reference Guides 83 TheFuture 85 References 85 Norma Skolnik Harry Fund PART I1 SCIENCE AND LABELS 4 . HAZARD ASSESSMENT AND CLASSIFICATION FOR LABELING 89 Introduction 89 Classification Under DOT Regulations 90 Adria C . Casey Contents XU Forbidden Materials 91 Explosives and Blasting Agents 92 Flammable and Combustible Liquids 93 Flammable Solids. Oxidizers and Organic Peroxides 94 Corrosive Materials 94 Non-flammable and Flammable Gases 95 Poisonous and Irritating Materials 96 Etiologic Agents 97 Radioactive Materials 99 Other Regulated Materials (ORM) 100 Selection of a Proper Shipping Name 103 Classification Under RCRA Regulation 103 Definition of Hazardous Wastes 104 Empty Containers 120 Some RCRA Exemptions 120 Classification Under FIFRA Regulations 121 summary 122 Footnotes 123 Materials Meeting the Criteria of More Than One Hazard Class . . 102 5 . LABELS AND MEDICINE 128 Introduction 128 Development of First Aid Statements 131 Richard Moriarty 6.ACUTETOXICITY 141 Donald G . MacKellar Introduction 141 Routes of Administration 142 Oral Administration 142 Dermal Toxicity 143 Inhalation 143 Ocular Toxicity Tests 145 Dermal Irritation 145 Intravenous or Intramuscular Injection 145 Species Selection 145 Animal Husbandry 146 Conduct of the Test 147 Calculation of Results 148 Test Protocols and Guidelinee 152 Guidelines 152 Acute Oral Toxicity 152 Acute Dermal Toxicity 156 Acute Inhalation 162 Eye Irritation 167 Skin Irritation or Corrosion 174 References 178 Suggested Reading 178 7 . CHRONIC TOXICITY 179 Principlee of Chronic Toxicity 179 Introduction 179 Anthony J . Garro xvi Contents General Design of Chronic Toxicity Studies: Carcino- genesis as a Model 180 Detection of Mutagenic Substances and Application of Mutagen Screening Tests for the Detection of Chemical Carcinogens 184 Introduction 184 Microbial Tests 186 Mammalian Cells in Culture -188 Metabolic Activation 189 Insect Assays 190 In Vivo Mammalian Cytogenetic Tests 190 In Vivo Mammalian Genetic Assays 191 Application of Mutagen Screening Tests for the Detection of Chemical Carcinogens 193 Quantitative Comparisons of Mutagenic and Carcinogenic Activities -195 Effects and Neurotoxic Effects 196 Introduction 196 Nononcogenic Chronic Effects 196 Teratogenic Effects 197 Reproductive Effects 197 Neurotoxic Effects 198 Toxicity Test Data to Humans 198 Epidemiology as a Toxicological Tool 198 DNA Repair-Dependent Assays of DNA Damage 189 Noncarcinogenic Chronic Effects: Teratogenic/Reprodudive Epidemiological Considerations and Application of Chronic Qualitative Validation of Rodent Bioassays for the Identifica- Validation of Animal Assays for Identifying Other Types of Quantitative Risk Estimates 201 References 206 tion of Chemical Carcinogens 199 Chronic Chemical Exposure-Related Health Effects 201 PART I11 PRODUCT LIABILITY. REGULATIONS AND LABELS 8 . PRODUCT LIABILITY AND LABELS 217 Overview 217 The Social Philosophy and Principles of the Common Law Duty toWarn 219 The Common Law of Torts 219 Negligence 219 Strict Liability 220 Other Theories of Liability 221 Review 225 Review of Court Decisions 226 The Risk of Harm-What Must A Manufacturer Know About His Own Product? 226 Foreseeability-What Must A Manufacturer Foresee About How His Product Will Be Used? 229 What Kind of A Warning Must Be Given? 232 David F . Zoll Contents xvii How Far Into the Chain of Commerce Must the Warning Be Sent? 236 Suggested “Duty To Warn” Checklist 241 Overview-The Need For an Information System 241 Product 244 Identify Mandatory Requirements 244 Identify Industry Customs and Practices 245 Identify Foreseeable Uses and Misuses Of The Product 245 cation Available 245 Use Common Sense C 246 Congressional Initiatives in the Product Liability Arena 246 Collateral Issues 246 Footnotes 247 9 . PATENTS, TRADE SECRETS AND TRADEMARKS 252 Patents -252 Basic Coverage of the Patent Act 253 The Importance of Patent Searches 259 Protection in Foreign Countries 260 Label Licenses and Patent Misuse 260 Patent Marking 262 Trade Secrets 263 Compile Health And Environmental Effects Information On The Identify The Primary and Supplementary Methods of Communi- Consider the Efficiency of the Specific Messages of Warning . . 245 James Toupin Patent Disclosure Requirements and Trade Secret Protection . . 257 Basic Requirements and Relationship to Patent Protection 264 Trade Secrets and Labelling Hazardous Substances 268 Trademarks 271 Types of Marks Protected 271 The Choice of Trademarks 273 The Usefulness of Searches in Choosing Trademarks 274 Guidelines for Preventing Trademarks from Becoming Unprotectable 275 Registering Trademarks 276 Trademark Registration Marking 278 Copyright and Trademark Protection of Labels Compared 279 Footnotes 279 10 . PESTICIDE LABELING UNDER THE FEDERAL INSECTICIDE. FUNGICIDE AND RODENTICIDE ACT (FIFRA) 281 Introduction 281 EPA’s Pesticides Program 282 Introduction 282 Registration 282 Conditional Registration 283 Tolerances -283 Special Registrations 284 Reregistration 284 Rebuttable Presumption Against Registration (RPAR) 284 Imports and Exports 285 Steven D . Jellinek xviii Contents Information That Must Be Included In Pesticide Labels 285 General 285 Product Identification 286 Warnings and Precautionary Statements 288 Directions For Use 292 Format of Pesticide Labels 295 General 295 Placement of the Label 295 Placement and Prominence of Label Statements 297 Labeling for Experimental Use Permits 298 Label Improvement Program 298 Conclusion 299 11 . LABELING UNDER THE TOXIC SUBSTANCES CONTROL ACT (TSCA) 300 Robert M . Sussman EPA's General Labeling Authority Under Section 6(a) 301 Definition of Unreasonable Risk 302 Hearings 306 Adequate Protection 306 Least Burdensome Requirement 306 Category of Chemicals 307 Relation to Other Statutes 308 Effective Date 308 Required Testing 308 Labeling Requirements for PCBs 311 EPA's Disposal Regulations 312 Confidentiality Protections 309 Statutory Provisions Relating to PCBs 311 EPA's Ban Regulations 313 Court Decisions Involving PCBs 314 Footnotes 314 12 . LABELING UNDER THE RESOURCE CONSERVATION AND RECOVERY ACT (RCRA) 316 Robert M . Sussman and Jennifer Machlin The Statutory Hazardous Waste Management Program 316 1004(27) and 3001 316 3002,3003, and 3004 318 RCRA Requirements for Labeling Hazardous Waste 320 Part 171: General Information 321 Part 172: Hazardous Waste Communication Regulations 321 Part 173: General Shipment and Packaging Requirements 322 Parts 174-177: Shipment of Hazardous Waste by Rail, Air, Vessel, and Public Highway 322 Parts 178-179: Shipping Container and Tank Specifications . . 323 Identification of Hazardous Waste: RCRA 8 0 1004(5), Standards Applicable to Persons Who Generate, Transport, Treat, Store, or Dispose of Hazardous Wastes: RCRA 8 8 13 . LABELING REQUIREMENTS ADMINISTERED BY THE CON- SUMER PRODUCT SAFETY COMMISSION (CPSC) 324 Labeling Under the FHSA 325 Robert M . Sussman [...]... involved in the labeling of chemical products Specifically this chapter will cover (1)the functions of labeling, (2) the underlying perceptual issues associated with labeling, (3) the perceptual impact of labeling, (4) existing research information concerning hazard labeling, (5) procedures for evaluating labeling, and (61, suggestions to guide the development of labeling FUNCTIONS OF LABELING Background... 1provides a discussion of the functions of labeling and the nature of labeling as a communications system whose function is to deliver a message or messages to a reader or consumer The chapter provides a definition of labeling and discusses in some detail the purposes of labeling industrial products and products in general Alternative perspectives of the importance of the labeling process in industry are presented... introduction to the problems involved in hazard labeling in the industry This is followed by a detailed summary of the major perceptual issues associated with labeling, including the processes of perception, attention, form, 1 2 Handbook of Chemical Industry Labeling color, color preferences and emotional characteristics, and visibility, and a discussion of color and hazard labeling The chapter also discusses... communication value of labels, and relates these to the issues associated with hazard labeling The reader is provided with a discussion of the methods now available and in use for testing the efficiency and effectiveness of labeling The chapter provides the reader with a summary of research and results of research conducted with respect to hazard labeling in the areas of foods, drugs, chemicals, children... to precautionary labeling periodically, culminating in 1976 as the American National Stundurd (2129.1)for the Precautionary Labeling of Hazardous Zndustrial Chemicals It was the need to serve these three major populatiom+labor, industry, and the public that led to publication of this handbook It is designed to provide an in-depth review of, and act as a source for the major elements of a Hazard Label... disadvantages of different methods of production for different types of labeling The chapter then gives the labeler a series of guidelines for production of the label, and provides a bibliography of sources for further information on the functional labeling process 1 Labels, Perception and Psychometrics Sidney I Lirtzman Graduate School and University Center and Baruch College City University of New York... Adria Casey explicates physical and chemical test parameters; and classification based on physical, chemical and biological data Labeling, Product Liability and Government Regulations form the major elements of Part 1 1 David Zoll of the Chemical Manufacturers Association leads 1 off with a discussion of product liability, the “prudent man” and case law James Toupin of Covington & Burling follows with... packaging and labeling were important factors in attracting customers, informing them of product lines, and developing and maintaining product loyalty The package and label gradually shifted away from almost purely functional roles to more sophisticated vehicles designed to communicate a variety of themes to potential and actual consumers 5 6 Handbook of Chemical Industry Labeling A review of such sources... the interest of information transfer to the user or worker, so as to enhance the “right to know.” The reader may find it useful to review a related perspective on labeling functions and orientations provided in the Bambury Report #6 entitled “Product Labeling and Health Risks” edited by Morris et al (1980) Hazard Labeling A critical aspect of chemical industry product labeling is the fact of government... to affect the perceptions and behavior of human beings who are prospective users of the products Although other factors such as the material safety data sheets (MSDS) are important parts of labeling we will not deal with them in this chapter I will refer to them where appropriate in the context of discussion or research Purpose of Labeling Probably no aspect of a package is as frequently taken for . 1098765 Library of Congress Cataloging in Publication Data Main entry under title: Handbook of chemical industry labeling. Includes bibliographies and index. 1. Chemicals- -Labeling- -Law. definition of labeling and discusses in some detail the purposes of labeling industrial products and products in general. Alternative perspectives of the importance of the labeling process in industry. effectiveness of labeling. The chapter provides the reader with a summary of research and results of research conducted with respect to hazard labeling in the areas of foods, drugs, chemicals,