Description
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.
Table of Contents
Contents
Preface..............................................................................................................................................vii
Editor ................................................................................................................................................ix
Contributors ......................................................................................................................................xi
Chapter 1 Introduction ..................................................................................................................1
Shayne C. Gad
Chapter 2 Human Pharmaceutical Product Safety ..................................................................... 11
Shayne C. Gad
Chapter 3 Animal Health Products ............................................................................................. 67
Elizabeth Roberts
Chapter 4 Regulatory Aspects and Strategy in Medical Device and Biomaterials
Safety Evaluation ........................................................................................................83
Shayne C. Gad
Chapter 5 Food Additives and Nutrition Supplements ............................................................. 113
Chada S. Reddy and A. Wallace Hayes
Chapter 6 Regulations Affecting Cosmetic and Personal Care Products ................................. 149
Bennett Varsho and George DeGeorge
Chapter 7 OTC Drugs and Nutraceuticals ................................................................................ 167
Charles B. Spainhour
Chapter 8 Consumer Products: Nonpersonal Care Products Regulatory Review
and Labeling ............................................................................................................. 179
Robert W. Kapp and Denese A. Deeds
Chapter 9 Agricultural Chemicals: Regulation, Risk Assessment, and Risk Management ....... 197
Elliot Gordon
Chapter 10 Industrial Chemicals Regulation of New and Existing Chemicals (The Toxic
Substances Control Act and Similar Worldwide Chemical Control Laws).............. 219
Sol Bobst and Richard C. Kraska
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
Edward V. Sargent
Chapter 12 Federal Air and Water Regulations: Clean Air Act, Clean Water Act, and
Safe Drinking Water Act ..........................................................................................265
Alicia A. Taylor and M. Yusuf Khan
Chapter 13 Understanding the Safe Drinking Water and Toxic Enforcement Act of 1986
(California’s Proposition 65) .................................................................................... 281
Clint Skinner
Chapter 14 Safety Data Sheets .................................................................................................... 291
Dexter W. Sullivan, Jr.
Chapter 15 Genetically Modified Organisms—Evolution or Revolution of Genetics:
Assessing the Health Risks of Foods and Crops ......................................................307
John A. Budny
Chapter 16 Oversight Regulations .............................................................................................. 321
Robin C. Guy
Appendix I: Selected Regulatory and Toxicological Acronyms .............................................. 335
Appendix II ................................................................................................................................... 339
Index .............................................................................................................................................. 345
