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Regulatory Toxicology 3Rd Edition by Shayne C Gad, CRC Press

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  • General Information  
    Author(s)Shayne C Gad
    PublisherCRC Press
    Edition3rd Edition
    Publish YearAugust 2018


    CRC Press Regulatory Toxicology 3Rd Edition by Shayne C Gad

    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.

    Key Features:- 
    • Describes regulatory testing requirements for all the major classes of marketed products
    • Explains how to prepare required documents for mandated safety testing of product
    • Features new chapters addressing Safety Data Sheet Preparation and Regulatory Requirements for GMOs
    • Covers Safety Data Sheet Preparation, which has replaced the Material Safety Data Sheet system

    Table of Contents:-

    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