Regulatory Toxicology, Third Edition

This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require.

Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California’s Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.

Contents

Preface..............................................................................................................................................vii

Editor ................................................................................................................................................ix

Contributors ......................................................................................................................................xi

Chapter 1 Introduction ..................................................................................................................1

Chapter 2 Human Pharmaceutical Product Safety ..................................................................... 11

Chapter 3 Animal Health Products ............................................................................................. 67

Chapter 4 Regulatory Aspects and Strategy in Medical Device and Biomaterials

Safety Evaluation ........................................................................................................83

Chapter 5 Food Additives and Nutrition Supplements ............................................................. 113

Chapter 6 Regulations Affecting Cosmetic and Personal Care Products ................................. 149

Chapter 7 OTC Drugs and Nutraceuticals ................................................................................ 167

Chapter 8 Consumer Products: Nonpersonal Care Products Regulatory Review

and Labeling ............................................................................................................. 179

Chapter 9 Agricultural Chemicals: Regulation, Risk Assessment, and Risk Management ....... 197

Chapter 10 Industrial Chemicals Regulation of New and Existing Chemicals (The Toxic

Substances Control Act and Similar Worldwide Chemical Control Laws).............. 219

Chapter 11 Industrial Chemicals: Hazard Communication, Exposure Limits, Labeling

and Other Workplace and Transportation Requirements under Occupational

Safety and Health Administration, Department of Transportation, and

Similar Authorities around the World ...................................................................... 253

Chapter 12 Federal Air and Water Regulations: Clean Air Act, Clean Water Act, and

Safe Drinking Water Act ..........................................................................................265

Chapter 13 Understanding the Safe Drinking Water and Toxic Enforcement Act of 1986

(California’s Proposition 65) .................................................................................... 281

Chapter 14 Safety Data Sheets .................................................................................................... 291

Chapter 15 Genetically Modified Organisms—Evolution or Revolution of Genetics:

Assessing the Health Risks of Foods and Crops ......................................................307

Chapter 16 Oversight Regulations .............................................................................................. 321

Appendix I: Selected Regulatory and Toxicological Acronyms .............................................. 335

Appendix II ................................................................................................................................... 339

Index .............................................................................................................................................. 345

Editor

Shayne C. Gad, BS (Whittier College, Chemistry and Biology, 1971) and PhD in Pharmacology/

Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-five-yearold

consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical

companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at

Searle, Synergen, and Beckton Dickinson. He has published 50 books and more than 350 chapters,

articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and

safety assessment. He has more than 40 years of broad-based experience in toxicology, drug and

device development, statistics, and risk assessment. He has specific expertise in neurotoxicology,

in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology.

Past president of the American College of Toxicology, the Roundtable of Toxicology

Consultants, and three of SOT’s (Society of Toxicology) specialty sections. He has direct involvement

in the preparation of Investigational New Drug applications (INDs, 115 successfully to date), New

Drug Application (NDA), Product License Application (PLA), Abbreviated New Drug Application

(ANDA), 501(k), Investigational Device Exemption (IDE), Common Technical Document (CTD),

clinical data bases for phase 1 and 2 studies, and Premarket Approval Applications (PMAs). He has

consulted for the Food and Drug Administration (FDA), Environmental Protection Agency (EPA),

and National Institutes of Health (NIH), has trained reviewers, and has been an expert witness for

the FDA. He has also conducted the triennial toxicology salary survey as a service to the profession

for the last 29 years.

Dr. Gad is also a retired Navy officer with more than 26 years in service.