Foreword xix
Preface xxi
Prologue xxiii
Part I: Nanotechnology and Risks 1
1 Understanding Nanoparticles and Their Probable Risks 3
1.1 What is Nanotechnology? 3
1.2 Unique Properties of Nanoparticles that Differentiate Them from Their Bulk Counterpart 5
1.2.1 Magnetic Properties 6
1.2.2 Electrical Properties 6
1.2.3 Thermal Properties 7
1.2.4 Mechanical Properties 7
1.2.5 Chemical/Catalytic Properties 7
1.2.6 Optical Property 7
1.3 Fabrication of Nanoparticles 8
1.4 Uses of Nanoparticles in Consumer Products 10
1.5 Potential Risks Due to Harmful Effects of Nanoparticles 11
1.5.1 Risk Due to Interaction of Nanoparticles with Living Organisms 12
1.5.2 Short- and Long-Term Risks 13
1.6 Need for Measurement of Exposure to Nanoparticles 14
1.7 Conclusion 16
References 16
2 Nanotechnology, Nanoparticles, and Living Systems 19
2.1 Introduction 19
2.2 The Need for Nanotechnology in the Present-Day Scenario Cannot be Ignored 22
2.2.1 Increased Demand for Nanomaterial 23
2.2.2 Cheap and Clean Energy 24
2.2.2.1 Batteries 24
2.2.2.2 Fuel Cell 25
2.2.2.3 Wind Energy 25
2.2.2.4 Hydrogen Energy 26
2.2.3 Food Industry 26
2.2.3.1 Food Packaging Applications 26
2.2.3.2 Food Processing Applications 27
2.2.4 Defense Sector 28
2.2.4.1 Nano Armor 28
2.2.4.2 Nano for Faster and Intensive Medical Help 28
2.2.4.3 Nanotechnology-Based Weapons 29
2.2.4.4 Lighter and Faster Aircraft 29
2.2.4.5 Nanotechnology for Vehicles 30
2.2.4.6 Radar-Absorbing Material (RAM) 31
2.2.4.7 Portable Energy/Power 31
2.2.4.8 Nanotechnology for Satellites 31
2.2.4.9 Nanotechnology for Nuclear, Chemical, and Biological Warfare 32
2.2.5 Medical/Healthcare 32
2.2.5.1 Application in Drug Delivery 32
2.2.5.2 Nanodiagnostics Application 33
2.2.5.3 Application in Surgery 33
2.2.5.4 Application in Medical Robotics 33
2.2.6 Nanotechnology in Agriculture 34
2.2.6.1 Precision Farming 34
2.3 Interdependence and Interaction between Various Living Systems 37
2.3.1 Life-Cycle and Exposure Challenges 37
2.4 Concerns of Nanoparticle Properties Impacting Interaction with Living System 38
2.5 Concluding Remarks 39
References 40
3 Methodologies for Assessing Risks Associated with Human Health and the Environment by Nanotechnology-Based Products 43
3.1 Introduction 43
3.2 Workplace Exposure to Effects of Engineered Nanoparticles 44
3.3 Effects of Engineered Nanoparticles on Animals, Plants and Environment 46
3.4 Traditional Methods of Risk Assessment of Chemicals 47
3.4.1 What is PM 2.5? 47
3.4.2 Parameters and Concerns for Formulating Methods for Risk Assessment 48
3.4.3 Challenges Related to the Traditional Industrial Hygiene Approach 49
3.4.4 Traditional Instruments for Assessing Exposure 49
3.5 Methods for Risk Assessment of Nanoparticle 50
3.5.1 Control Banding to Analyze and Prioritize Risks from Nanomaterials 52
3.5.2 How to Measure and Assess Exposure to Nanoparticles 53
3.5.2.1 Measurement of Airborne or Gaseous Nanoparticles 54
3.5.2.2 Assessment of Nanoparticles in Liquid 54
3.5.3 Methods Used to Assess the Risk Due to Nanoparticles 54
3.6 Are Sufficient Methods Being Used to Assess the Risk from Nanoparticles? 56
3.6.1 Considerations to Assess Risks that Should be Taken into Account 57
3.6.2 Exposure Factors Required to be Specified for Risk Assessment Methodologies 58
3.6.3 How to Improve the Risk Assessment of Nanoparticles? 59
3.7 Conclusion 59
References 61
4 Human Health Risks Due to Inhaled Nanoparticles 63
4.1 Introduction 63
4.1.1 Sources of Nanoparticles 64
4.1.1.1 Natural Sources of Nanoparticles that we Cannot Avoid 64
4.1.1.2 Anthropogenic Sources of NPs that Need Careful Management 65
4.2 Inhalation Routes of NPs from Nose and Lungs to Other Organs of Human Body 66
4.2.1 Translocation of NPs to Different Sites of the Body 67
4.3 Cytotoxicological Considerations 67
4.3.1 Cellular Response 67
4.3.1.1 Oxidative Stress 67
4.3.1.2 Inflammation 68
4.3.1.3 Genotoxicity 68
4.3.1.4 Tumorigenicity 68
4.4 Known Hazardous Impact of Inhaled Nanoparticles on Human Health 68
4.4.1 The Respiratory Tract: Portal of Entry for NPs into the Human Body 69
4.4.2 Blood Circulation System: A Trojan Horse for Inhaled Nanoparticles 71
4.4.3 Cardiovascular System Leading to Cardiopulmonary Disease 72
4.4.4 Digestive System: Can it Digest Nanoparticles? 73
4.4.5 Kidneys: Can They Flux Out All NPs 74
4.4.6 Central Nervous System and Brain without an NP Barrier 74
4.4.7 Nanotoxicity against Reproductive System Organs 75
4.4.8 Hormone or Endocrine System Nanotoxicity 76
4.4.9 Cancer: Are Nanoparticles Friends or Foes? 76
4.5 Lung Bioassay Methodologies for Assessing Hazards after Exposures to Nanoscale or Fine Particulates 77
4.6 Strengths and Weaknesses of Risk Assessment 78
4.7 Concluding Remarks 80
Bibliography 80
5 Dermal Entry Route of NPs into the Human Body: A Risk? 89
5.1 Introduction 89
5.2 Dermal Entry Route of Nanoparticles 91
5.2.1 Pathways for Skin Absorption of Nanoparticles 92
5.2.1.1 Stratum Corneum (SC) 93
5.2.1.2 Skin Appendages 93
5.2.1.3 Interaction and Impact of Dermally Absorbed Nanoparticles with Biomolecules 93
5.3 Health Hazards of Dermal Exposure to NPs 95
5.4 Risk Handling and Evaluation of Dermal Exposure Hazards 96
5.5 Conclusion 98
References 99
6 Different Exposure Scenarios and Nanotoxicological Information 103
6.1 Introduction 103
6.2 Exposure Scenario to NPs 105
6.3 Nanoparticle Exposure and Biokinetic Pathways 107
6.3.1 Biokinetic Pathway of NPs via Inhalation 108
6.3.2 Biokinetic Pathway of Injected NPs 109
6.3.3 Biokinetics Pathway of Dermal Exposure to NPs 109
6.4 Nanotoxicity and Potential Mechanism 110
6.4.1 Size and Size Distribution of NPs 110
6.4.2 Morphology of NPs 110
6.4.3 Surface Properties Such as Surface Area (SA) and Mass Ratio (MR) 111
6.4.4 Chemical Composition and Surface Characteristics of NPs 111
6.4.5 Insolubility or Low Water Solubility of NPs 112
6.4.6 Agglomeration/Aggregation of NPs 112
6.5 Assessment of Toxicity of Nanoparticles 112
6.5.1 In-Vitro Toxicity Assay Method 112
6.5.2 In-Vivo Toxicity Assay Method 114
6.5.2.1 Histopathological Analysis 114
6.5.2.2 Blood Chemistry Analysis 115
6.5.2.3 Immunotoxicity Assessment 116
6.5.2.4 Genotoxicity Testing 117
6.5.2.5 Reproductive and Developmental Toxicity Studies 118
6.5.2.6 Organ-Specific Toxicity Assessment 118
6.5.2.7 Long-Term Exposure Studies 119
6.5.2.8 Behavioral Studies 120
6.5.2.9 Metabolomics and Proteomics 121
6.6 Risk Management of NPS 122
6.6.1 Identification of Hazards Caused by Nanomaterials 124
6.6.2 Guidance on Available Methods for Risk Assessment of Nanomaterials 125
6.6.3 (Q)SAR Models for Regulatory Assessment of Nanomaterial Risks 125
6.6.4 Can AI Help in Risk Management of NPs 128
6.6.4.1 Analyzing Data and Predictive Modeling 129
6.6.4.2 Toxicity Prediction 130
6.6.4.3 Environmental Impact Assessment (EIA) 131
6.6.4.4 Regulatory Compliance 132
6.7 Conclusion 134
References 134
7 Assessment of Risks Due to Nanoparticles in the Ecosystem 139
7.1 Introduction 139
7.1.1 Airborne Nanoparticles 141
7.1.2 Waterborne Nanoparticles 143
7.1.3 Nanoparticles in Soil 144
7.2 What to Consider for Nanoparticle-Related Assessment of Risks to Ecosystem 145
7.2.1 Identify and Characterize Properties of Nanoparticles of Concern 145
7.2.2 Bioavailability, Uptake and Toxicity Assessment 146
7.2.3 Exposure Assessment Fate and Transport of NP 147
7.2.4 Ecological Effects and Risk Characterization 147
7.2.5 Uncertainty and Variability 148
7.2.6 Risk Management and Mitigation 150
7.3 Monitoring and Surveillance 153
7.3.1 Monitoring Strategies 154
7.3.1.1 Remote Sensing 154
7.3.1.2 Tracking Technologies 155
7.3.1.3 Challenges and Considerations 156
7.4 Stakeholder Engagement 156
7.4.1 Government Agencies 156
7.4.2 International Organizations 157
7.4.3 Researchers and Scientists 157
7.4.4 Health Professionals 157
7.4.5 Industry 157
7.4.6 Non-Governmental Organizations (NGOs) 158
7.4.7 Consumers 158
7.4.8 Media 158
7.5 Concluding Remarks 158
References 159
Part II: Ethical Aspects 163
8 Ethics Governance and Policies: Problems and Concerns 165
8.1 Introduction 165
8.2 How Does Ethics Pertain to Nanotechnology? 167
8.2.1 Ethics and Nanotechnology in the Workplace 171
8.3 Framework for Ethical Analysis of Nanotechnology 172
8.3.1 Considerations for Framework 172
8.3.2 Privacy 175
8.3.3 Security Concerns 176
8.3.4 Environmental Concerns 177
8.4 Governance and Policies Based on Ethics 178
8.4.1 Subjectivity 178
8.4.2 Complexity 179
8.4.3 Enforcement of Policy 179
8.4.4 Evolution of Ethics and Ethical Dilemmas 179
8.5 Problems and Challenges Faced in Addressing Ethical Concerns 180
8.5.1 Complexity 181
8.5.2 Subjectivity 181
8.5.3 Cost and Resource Constraints 182
8.5.4 Changing Landscapes 182
8.5.5 Lack of Awareness, Education and Training 183
8.5.6 Health and Environment-Related Challenges 183
8.5.7 Organizational Ethics 184
8.5.8 Legal and Regulatory Compliance 184
8.6 Concluding Remarks 185
References 185
9 Bioethical Questions: Ethically Assessing Toxicology and Human Health 187
9.1 Introduction 187
9.2 Organizations Involved in Ethically Assessing Health Risks 188
9.2.1 International Organizations 188
9.2.1.1 World Health Organization (WHO) 189
9.2.1.2 United Nations Office for Disaster Risk Reduction (UNDRR) 189
9.2.1.3 International Risk Governance Council (IRGC) 190
9.2.1.4 International Organization for Standardization (ISO) 190
9.2.1.5 Environmental Protection Agency (epa) – USA 190
9.2.1.6 Federal Emergency Management Agency (fema) – USA 191
9.2.1.7 National Institute for Occupational Safety and Health (NIOSH) – USA 191
9.2.1.8 European Food Safety Authority (EFSA) 191
9.2.2 Financial and Economic Organizations 192
9.2.3 Academic and Research Institutions 192
9.2.4 Industry and Private Sector 192
9.3 How to Assess Risk and Uncertainty 192
9.3.1 Risk Assessment Frameworks 193
9.3.2 Identification of Potential Hazards 194
9.3.3 Exposure Assessment 194
9.3.4 Toxicity Assessment 194
9.3.5 Quantifying Uncertainty and Data Gaps 194
9.3.6 Risk Management 195
9.3.7 Ethical Considerations, Communication and Stakeholder Engagement 196
9.4 Potential Human Health Impacts Due to Exposure to Nanoparticles 196
9.5 Mitigation of NP-Related Environmental Concerns Affecting Health 199
9.5.1 Monitoring and Assessment of Risk to Mitigate Effect of NPs 200
9.5.2 Safe Nanoparticle Design and Practices to Mitigate Effect of NPs 200
9.5.3 Environmental Remediation and Nano-Bioremediation to Mitigate Effect of NPs 201
9.5.4 Education and Public Awareness to Mitigate Effects of Nanoparticles 202
9.5.5 Regulation and Policies to Mitigate Effects of Nanoparticles 202
9.6 Equitable Distribution of the Benefits of Nanotechnology 203
9.7 How to Ensure Human Exposure to Nanoparticles and Informed Consent 205
9.8 Regulatory Framework for Nanotechnology 207
9.9 How to Tackle the Dual-Use Dilemma of Nanoproducts 209
9.10 Ethical Boundaries of Privacy and Surveillance Regarding Nanotechnology 210
9.11 Balancing Long-Term Effects and Precautionary Principle Pertaining to NPs 212
9.12 Fostering Global Collaboration in Research, Regulation and Governance of Nanotechnology 214
9.13 Concluding Remarks 217
References 218
10 Diseases and Virus Theranostics for Rewriting the Ethical Risk Management 223
10.1 Introduction 223
10.2 Theranostics in Disease and Virus Management 224
10.3 Ethical Risk Management and Risk Rewriting 225
10.3.1 Ethical Risk Management 226
10.3.2 Rewriting Risk 226
10.4 Some Notable Examples of Theranostic Approaches 227
10.4.1 Theranostics for Cancer Treatment 227
10.4.2 Theranostics for Infectious Disease Caused by Virus 227
10.4.3 Theranostics for Neurological Disorders Caused by Virus 228
10.4.4 Theranostics in Viral Neurological Diseases 230
10.5 Integration of Theranostics with Ethical Management 231
10.6 Concluding Remarks 233
References 233
11 COVID-19 Therapy and Vaccine: An Eye Opener to Risk and Ethics 235
11.1 Introduction 235
11.1.1 An Overview of COVID-19 and History of SARS-CoV- 2 236
11.2 COVID-19 Therapies 237
11.2.1 Overview of Early Treatments 238
11.3 Vaccine Development and Science Behind COVID- 19 Vaccine 239
11.3.1 mRNA Vaccine 239
11.3.2 Vector-Based Vaccine 240
11.3.3 Protein Subunit Vaccine 241
11.4 Potential Harm and Risk Assessment of COVID? 19 Therapies and Vaccines 242
11.4.1 Potential Harmful Effects of COVID-19 Therapies 243
11.4.1.1 Adverse Drug Reactions 243
11.4.1.2 Off-Label Use of Existing Medications 244
11.4.2 Potential Harmful Effects of COVID-19 Vaccines 244
11.4.2.1 Vaccine-Related Adverse Events 244
11.4.2.2 Vaccine Hesitancy 244
11.5 Ethical Considerations in Applying COVID-19 Therapies 244
11.5.1 Resource Allocation and Fairness 245
11.5.2 Ethical Guidance During COVID- 19 245
11.6 Ethical Considerations in Using Vaccine 245
11.6.1 COVID-19 Vaccine Allocation Principles 246
11.6.2 Informed Consent 247
11.6.3 Equitable Distribution/Access 248
11.6.4 Ethics of Balancing Vaccine Mandates with Public Health 248
11.6.5 Transparent Communication 249
11.6.6 Data Privacy 249
11.6.6.1 The Dilemma: Public Health vs. Personal Privacy 249
11.6.6.2 Stricter Data Protection Regulations 250
11.6.6.3 Balancing Privacy and Health Protection 250
11.6.6.4 Legal Guidance and Privacy Laws 250
11.6.7 Risk Mitigation Strategies 250
11.6.7.1 Some Case Studies in Ethics 250
11.7 Role of Nanotechnology in COVID Therapy and Vaccine 251
11.7.1 Nanotechnology in COVID-19 Vaccines 251
11.7.2 Nanotechnology in COVID-19 Therapy 252
11.7.3 Nanotechnology in COVID-19 Diagnostics 252
11.7.4 Nanotechnology in Immune Modulation for Covid- 19 252
11.7.5 Nanotechnology in Antiviral Personal Protective Equipment 252
11.8 Conclusion 253
References 253
12 Social Ethics, Issues, and Anthropological Questions and Uncertainties in ID Detection 257
12.1 Introduction 257
12.2 Social Ethics and Nanotechnology 258
12.2.1 Health Safety Risks and Social Ethics Due to Nanotoxicity 259
12.2.2 Environmental Impact of Nanomaterial Causing Ecological Risks and Concern for Social Ethics 259
12.2.3 Privacy and Nano-Surveillance Related to Social Ethics 260
12.2.4 Social Inequality: Access to Benefits of Nanotechnology Related to Social Ethics 260
12.2.5 Economic and Employment Disruption or Job Displacement Due to Monopolization of Knowledge About Nanotechnology 261
12.2.6 Nano-Related Regulation and Governance Encompassing Regulatory Oversight 262
12.2.6.1 Regulatory Oversight at the National and Regional Level 262
12.2.6.2 Challenges in Global Standardization 263
12.2.6.3 Potential Pathways for Global Governance 264
12.2.7 Nanotechnology Led Human Enhancement: Ethical Dilemmas in Human Augmentation 264
12.2.7.1 Nanotechnology and Human Enhancement 265
12.2.7.2 Ethical Implications for Identity and Personhood 265
12.2.8 Nano-Weaponization and Dual-Use Dilemmas in Military and Security: An Ethical Concern 266
12.2.8.1 Nano-Weaponization 266
12.2.8.2 Dual-Use Dilemma 266
12.2.8.3 Ethical Concerns 267
12.2.8.4 Possible Solutions and Ethical Guidelines 268
12.3 Anthropological Questions Pertaining to Nanotechnology 268
12.4 Uncertainties in Detection (ID Detection) Concerning Nanotechnology 269
12.5 Conclusion 273
References 274
Epilogue 277
Index 289
