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Biotechnology and Nanotechnology [Hardback]

  • Formāts: Hardback, 352 pages, height x width x depth: 243x164x23 mm, weight: 634 g
  • Izdošanas datums: 01-Jul-2009
  • Izdevniecība: Oxford University Press Inc
  • ISBN-10: 0195340086
  • ISBN-13: 9780195340082
Citas grāmatas par šo tēmu:
Biotechnology and NanotechnologyPalielināt
  • Formāts: Hardback, 352 pages, height x width x depth: 243x164x23 mm, weight: 634 g
  • Izdošanas datums: 01-Jul-2009
  • Izdevniecība: Oxford University Press Inc
  • ISBN-10: 0195340086
  • ISBN-13: 9780195340082
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780195340082.html
Keywords:
Biotechnology & Nanotechnology: Regulation Under Environmental, Health, and Safety Laws analyzes regulation governing biotechnology and nanotechnology industries. Regulation of biotechnology, which generally encompasses the manipulation of living materials by passing genetic information from one organism to another, emerged in the 1970's and is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields. Nanotechnology, which refers to the design and production of molecular-sized devices and products, is a more recent field whose regulation has an impact on the same industries as biotechnology and also affects semiconductors, communications technology, cosmetics, and consumer products. Additional regulation is quite likely because the need for knowledge of the risks involved in industry processes and products is increasing. Both fields are subject to the same regulatory schemes, and this book describes the application of substantive laws, such as the Federal Food, Drug, and Cosmetic Act, the Clean Water Act, and the Clean Air Act, to each segment of the biotechnology nanotechnology industry. Also discussed are international issues and ongoing development of regulations governing these fields.
Preface xv
List of Acronyms xvii
CHAPTER
1. INTRODUCTION TO REGULATION OF BIOTECHNOLOGY AND NANOTECHNOLOGY		 1
CHAPTER
2. WHAT IS BIOTECHNOLOGY? WHAT IS NANOTECHNOLOGY?		 5
I. Biotechnology
5
A. The Evolution of Modern Biotechnology
5
B. The Use of Modern Biotechnology Techniques
6
II. Nanotechnology
8
A. The Major Theoretical and Initial Breakthroughs in Nanotechnology
8
B. Uses of Nanotechnology
13
CHAPTER
3. UNDERSTANDING THE RISKS FROM NANOTECHNOLOGY AND BIOTECHNOLOGY		 17
I. Introduction
17
II. History of the Risk Assessment Paradigm
18
III. Health Risk Assessment
20
A. The Basics of Toxicity: Hazard Identification and Dose Response
20
B. The Basics of Exposure-Dynamics
26
IV. Environmental Risk of Agricultural Biotechnology and Nanotechnology
33
A. Environmental Impacts from Genetically Modified Organisms
34
B. Environmental Consequences from Nanomaterials
37
V. Economic and Ethical Consequences
38
A. Economic Consequences of Transgenic Plants
38
B. Ethical Issues Associated with Transgenic Plants
39
C. Economic and Ethical Issues with Nanomaterials
40
VI. Assessment of Risk under Conditions of Uncertainty
42
VII. Impact of Public Perception on the Formulation of Regulatory Policy with Regard to New Technology
43
A. Perceptions of Agricultural Biotechnology
43
B. Perceptions of Nanotechnology
44
VIII. The Theoretical Components of the Precautionary Principle
45
CHAPTER
4. CREATION OF A REGULATORY STRUCTURE		 47
I. Development of the Regulatory Structure for Biotechnology
50
A. Early Years of Scientific Self-Regulation: Gordon Conference, National Academy of Sciences, and the Asilomar Conference
50
B. National Institutes of Health Recombinant DNA Advisory Committee and the National Institutes of Health Guidelines
52
C. Office of Science and Technology Policy's Coordinated Framework
53
II. The Federal Government's Nanotechnology Efforts
59
A. Funding of Nanotechnology—From IWGN to NNI and Beyond
59
B. NEHI and Funding Environmental, Health, and Safety Research
62
C. The Overall Regulatory Framework Governing Nanomaterials
64
CHAPTER
5. REGULATION OF TRANSGENIC PLANTS AND ANIMALS		 67
I. Overview of the Current Role of Transgenic Plants in American Agriculture
67
II. Federal Regulation of Transgenic Plants
69
A. The Historical Evolution of Laws
69
B. Current USDA Regulations
71
III. The National Environmental Policy Act
81
IV. USDA Regulation of Industrial and Pharmaceutical Transgenic Plants
84
V. Federal Regulation of Plant Incorporated Protectants
85
A. Regulatory Scope of the Federal Insecticide, Fungicide, and Rodenticide Act
85
B. Specific Regulations or Guidance on Plant Incorporated Protectants
87
C. Experimental Use Permits
88
D. Registration Process
92
E. Special Local Needs Registration
96
F. Reporting Obligations
97
G. Cancellation and Suspension
98
VI. Federal Regulation of Pesticidal Residues
103
A. Substantive Criteria for Establishing Tolerances
104
B. Procedural Criteria for Establishing Tolerances
105
VII. Case Studies
108
A. Bt Corn and Monarch Butterflies Case Study
108
B. Star LinkTM Case Study
112
VIII. Federal Regulation of Genetically Modified Microorganisms
113
A. Jurisdiction and Role of EPA under the Toxic Substances Control Act
114
B. Jurisdiction and Role of EPA under FIFRA
126
C. Regulation of Nanopesticides
127
IX. Federal Regulation of Transgenic Animals
130
A. Jurisdiction and Role of the FDA under the Food, Drug, and Cosmetic Act
131
B. Transgenic Salmon Case Study
137
C. Jurisdiction and Role of USDA under Inspection Acts
139
CHAPTER
6. REGULATION OF FOOD		 141
I. The Debate between Advocates for GM Food and Critics of "Frankenfoods"
141
II. United States: Jurisdiction over Foods
143
A. Adulteration Standard
143
B. Misbranding and Labeling Provisions
145
C. GRAS and Food Additive Petitions
146
D. Documents on Genetically Modified Foods
150
III. Case Studies
159
A. FLAVR SAVRTM Tomatoes
159
B. rbST Milk
162
IV. European Regulation of Genetically Modified Foods
164
A. The Context for European Regulations
164
B. Early Years of Regulation
166
C. The Current Regulatory Structure
167
D. The Significant Distinction between U.S. and European Regulatory Structure
176
V. Pushing New Frontiers: Food from Cloned Animals
177
VI. Nanomaterials and Foods
180
CHAPTER
7. DRUGS, BIOLOGICS, AND MEDICAL DEVICES		 183
I. Introduction
183
II. Understanding the Distinctions between Drugs and Biologics
184
III. The Evolution of FDA's Authority over Drugs and Biologics
185
A. Drugs
185
B. Biologics
186
IV. Investigative Process for Biologics and Drugs
187
A. Preclinical Investigation
187
B. Investigational New Drug Applications
188
V. New Drug Application
194
A. Application Process
194
B. Post-Approval Reporting Obligation
197
VI. Regulation of Biologics
199
A. Permitting Process
199
B. Postmarketing Notification for Changes
202
C. Enforcement
203
VII. Other Mechanisms for Drug and Potentially Biological Product Approval
204
A. Generic Drugs
205
B. "Follow-On" Drugs
205
C. Biologics
206
VIII. General Overview of FDA's Medical Device Approval Process
207
A. Classification System
207
B. Premarket Application
208
C. Confidential Information
210
D. Postmarketing Surveillance
210
E. Section 510(k) Exemption Notification Process
211
F. Investigative Device Exemption
213
G. Monitoring Obligations
215
H. Treatment Investigation Device Exemption
216
IX. The Development of Nanomedicine
217
A. Drugs and Drug Delivery Systems
217
B. Devices
220
CHAPTER
8. COSMETICS		 221
I. Overview of Regulation of Cosmetic Products
221
II. FDA Statutory Authority to Govern Cosmetics
222
A. Authority under the Federal Food, Drug, and Cosmetic Act
222
B. Authority under the Fair Packaging and Labeling Act
224
III. Cosmetic Regulation
225
A. Substantiation for Safety
225
B. Labeling
226
C. Color Additives
228
IV. Voluntary Registration System
229
A. Voluntary Registration of Establishments
229
B. Voluntary Registration of Ingredients
230
V. Enforcement Powers
231
VI. Drug versus Cosmetic Debate and the Role of Nanomaterials
231
CHAPTER
9. CONSUMER PRODUCTS		 237
I. The Nanomaterials in Consumer Products
237
II. The Consumer Product Safety Act
238
III. Federal Hazardous Substances Act
242
A. Labeling Requirements
243
B. Banning and Seizing Products
248
C. Export and Import Requirements
250
IV. CPSC Action and Nanotechnology
251
CHAPTER
10. CHEMICALS		 253
I. The Uses of Nanomaterials in Chemicals
253
II. Toxic Substances Control Act
254
A. Scope of TSCA
254
B. Statutory Exemptions
255
C. Testing and Regulation of Risks
256
D. Notice Provisions
258
E. Reporting Requirements
272
F. Penalty Policy and Citizen Suit Provision
276
III. Occupational Safety and Health Act
277
A. Hazard Communication
277
B. Chemical-Specific Standards and Permissible Exposure Limits
279
C. Personal Protective Equipment
280
D. Respiratory Protection Standard
281
E. Laboratory Standards
282
F. General Duty Clause
283
IV. Resource Conservation and Recovery Act
284
A. Defining Hazardous Waste and the Scope of Exceptions
285
B. Regulation of Generators
288
C. Transporter and Owners and Operators of Treatment, Storage, and Disposal Facilities
291
D. Enforcement Provisions
292
CHAPTER
11. EVOLUTION OF BIOTECHNOLOGY REGULATION AND THE FUTURE OF NANOTECHNOLOGY REGULATION		 295
I. Lessons Learned from the Regulation of Biotechnology
295
A. Lesson 1: Developing Environmental, Health, and Safety Data
295
B. Lesson 2: Addressing the Need for Labels and Traceability
297
C. Lesson 3: Need for Issuance of Timely Enforceable Rules and Regulations
299
II. Proposals and Initiatives for Regulating Nanotechnology
300
A. EPA's Nanoscale Materials Stewardship Program
300
B. NIOSH
303
C. FDA
305
D. Nongovernmental Organizations
306
E. Business/NGO Alliances
307
III. Concluding Thought on Nanotechnology
309
Index 311