| Description |
1 online resource (367 pages) |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Editor; Contributors; Chapter 1: Introduction; Chapter 2: Human Pharmaceutical Product Safety; Chapter 3: Animal Health Products; Chapter 4: Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation; Chapter 5: Food Additives and Nutrition Supplements; Chapter 6: Regulations Affecting Cosmetic and Personal Care Products; Chapter 7: OTC Drugs and Nutraceuticals; Chapter 8: Consumer Products: Nonpersonal Care Products Regulatory Review and Labeling |
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Chapter 9: Agricultural Chemicals: Regulation, Risk Assessment, and Risk ManagementChapter 10: Industrial Chemicals Regulation of New and Existing Chemicals (The Toxic Substances Control Act and Similar Worldwide Chemical Control Laws); 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 |
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Chapter 12: Federal Air and Water Regulations: Clean Air Act, Clean Water Act, and Safe Drinking Water ActChapter 13: Understanding the Safe Drinking Water and Toxic Enforcement Act of 1986 (California's Proposition 65); Chapter 14: Safety Data Sheets; Chapter 15: Genetically Modified Organisms-Evolution or Revolution of Genetics: Assessing the Health Risks of Foods and Crops; Chapter 16: Oversight Regulations; Appendix I: Selected Regulatory and Toxicological Acronyms; Appendix II; Index |
| Summary |
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 |
| Notes |
Print version record |
| Subject |
Poisons -- Law and legislation -- United States
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Toxicity testing -- Law and legislation -- United States
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Forensic toxicology -- United States
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Hazardous substances.
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Legislation, Drug
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Toxicity Tests
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Toxicology -- Standards
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Legislation, Food
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Environmental Exposure -- legislation and jurisprudence
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Forensic toxicology.
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Poisons -- Law and legislation.
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Toxicity testing -- Law and legislation.
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MEDICAL -- Pharmacology.
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Forensic toxicology.
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Hazardous substances.
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Poisons -- Law and legislation.
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Toxicity testing -- Law and legislation.
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United States.
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| Form |
Electronic book
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| ISBN |
9780429876516 |
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0429876513 |
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