Risk, Safety, and Ethical Concerns in Nanotechnology

Madhuri Sharon, PhD is the Director of the Sharon Institute of Nanotechnology, Managing Director of Monad Nanotechnology, and a mentor at Bhishma Sanatan Vedic University. She has published seven books, 11 patents, and over 250 research papers in international journals and conferences. Her research focuses on nanotechnology and bionanotechnology, nanoparticles for drug delivery, carbon quantum dots, carbon nanomaterials, and graphene.

• Foreword xixPreface xxiPrologue xxiiiPart I: Nanotechnology and Risks 11 Understanding Nanoparticles and Their Probable Risks 31.1 What is Nanotechnology? 31.2 Unique Properties of Nanoparticles that Differentiate Them from Their Bulk Counterpart 51.2.1 Magnetic Properties 61.2.2 Electrical Properties 61.2.3 Thermal Properties 71.2.4 Mechanical Properties 71.2.5 Chemical/Catalytic Properties 71.2.6 Optical Property 71.3 Fabrication of Nanoparticles 81.4 Uses of Nanoparticles in Consumer Products 101.5 Potential Risks Due to Harmful Effects of Nanoparticles 111.5.1 Risk Due to Interaction of Nanoparticles with Living Organisms 121.5.2 Short- and Long-Term Risks 131.6 Need for Measurement of Exposure to Nanoparticles 141.7 Conclusion 16References 162 Nanotechnology, Nanoparticles, and Living Systems 192.1 Introduction 192.2 The Need for Nanotechnology in the Present-Day Scenario Cannot be Ignored 222.2.1 Increased Demand for Nanomaterial 232.2.2 Cheap and Clean Energy 242.2.2.1 Batteries 242.2.2.2 Fuel Cell 252.2.2.3 Wind Energy 252.2.2.4 Hydrogen Energy 262.2.3 Food Industry 262.2.3.1 Food Packaging Applications 262.2.3.2 Food Processing Applications 272.2.4 Defense Sector 282.2.4.1 Nano Armor 282.2.4.2 Nano for Faster and Intensive Medical Help 282.2.4.3 Nanotechnology-Based Weapons 292.2.4.4 Lighter and Faster Aircraft 292.2.4.5 Nanotechnology for Vehicles 302.2.4.6 Radar-Absorbing Material (RAM) 312.2.4.7 Portable Energy/Power 312.2.4.8 Nanotechnology for Satellites 312.2.4.9 Nanotechnology for Nuclear, Chemical, and Biological Warfare 322.2.5 Medical/Healthcare 322.2.5.1 Application in Drug Delivery 322.2.5.2 Nanodiagnostics Application 332.2.5.3 Application in Surgery 332.2.5.4 Application in Medical Robotics 332.2.6 Nanotechnology in Agriculture 342.2.6.1 Precision Farming 342.3 Interdependence and Interaction between Various Living Systems 372.3.1 Life-Cycle and Exposure Challenges 372.4 Concerns of Nanoparticle Properties Impacting Interaction with Living System 382.5 Concluding Remarks 39References 403 Methodologies for Assessing Risks Associated with Human Health and the Environment by Nanotechnology-Based Products 433.1 Introduction 433.2 Workplace Exposure to Effects of Engineered Nanoparticles 443.3 Effects of Engineered Nanoparticles on Animals, Plants and Environment 463.4 Traditional Methods of Risk Assessment of Chemicals 473.4.1 What is PM 2.5? 473.4.2 Parameters and Concerns for Formulating Methods for Risk Assessment 483.4.3 Challenges Related to the Traditional Industrial Hygiene Approach 493.4.4 Traditional Instruments for Assessing Exposure 493.5 Methods for Risk Assessment of Nanoparticle 503.5.1 Control Banding to Analyze and Prioritize Risks from Nanomaterials 523.5.2 How to Measure and Assess Exposure to Nanoparticles 533.5.2.1 Measurement of Airborne or Gaseous Nanoparticles 543.5.2.2 Assessment of Nanoparticles in Liquid 543.5.3 Methods Used to Assess the Risk Due to Nanoparticles 543.6 Are Sufficient Methods Being Used to Assess the Risk from Nanoparticles? 563.6.1 Considerations to Assess Risks that Should be Taken into Account 573.6.2 Exposure Factors Required to be Specified for Risk Assessment Methodologies 583.6.3 How to Improve the Risk Assessment of Nanoparticles? 593.7 Conclusion 59References 614 Human Health Risks Due to Inhaled Nanoparticles 634.1 Introduction 634.1.1 Sources of Nanoparticles 644.1.1.1 Natural Sources of Nanoparticles that we Cannot Avoid 644.1.1.2 Anthropogenic Sources of NPs that Need Careful Management 654.2 Inhalation Routes of NPs from Nose and Lungs to Other Organs of Human Body 664.2.1 Translocation of NPs to Different Sites of the Body 674.3 Cytotoxicological Considerations 674.3.1 Cellular Response 674.3.1.1 Oxidative Stress 674.3.1.2 Inflammation 684.3.1.3 Genotoxicity 684.3.1.4 Tumorigenicity 684.4 Known Hazardous Impact of Inhaled Nanoparticles on Human Health 684.4.1 The Respiratory Tract: Portal of Entry for NPs into the Human Body 694.4.2 Blood Circulation System: A Trojan Horse for Inhaled Nanoparticles 714.4.3 Cardiovascular System Leading to Cardiopulmonary Disease 724.4.4 Digestive System: Can it Digest Nanoparticles? 734.4.5 Kidneys: Can They Flux Out All NPs 744.4.6 Central Nervous System and Brain without an NP Barrier 744.4.7 Nanotoxicity against Reproductive System Organs 754.4.8 Hormone or Endocrine System Nanotoxicity 764.4.9 Cancer: Are Nanoparticles Friends or Foes? 764.5 Lung Bioassay Methodologies for Assessing Hazards after Exposures to Nanoscale or Fine Particulates 774.6 Strengths and Weaknesses of Risk Assessment 784.7 Concluding Remarks 80Bibliography 805 Dermal Entry Route of NPs into the Human Body: A Risk? 895.1 Introduction 895.2 Dermal Entry Route of Nanoparticles 915.2.1 Pathways for Skin Absorption of Nanoparticles 925.2.1.1 Stratum Corneum (SC) 935.2.1.2 Skin Appendages 935.2.1.3 Interaction and Impact of Dermally Absorbed Nanoparticles with Biomolecules 935.3 Health Hazards of Dermal Exposure to NPs 955.4 Risk Handling and Evaluation of Dermal Exposure Hazards 965.5 Conclusion 98References 996 Different Exposure Scenarios and Nanotoxicological Information 1036.1 Introduction 1036.2 Exposure Scenario to NPs 1056.3 Nanoparticle Exposure and Biokinetic Pathways 1076.3.1 Biokinetic Pathway of NPs via Inhalation 1086.3.2 Biokinetic Pathway of Injected NPs 1096.3.3 Biokinetics Pathway of Dermal Exposure to NPs 1096.4 Nanotoxicity and Potential Mechanism 1106.4.1 Size and Size Distribution of NPs 1106.4.2 Morphology of NPs 1106.4.3 Surface Properties Such as Surface Area (SA) and Mass Ratio (MR) 1116.4.4 Chemical Composition and Surface Characteristics of NPs 1116.4.5 Insolubility or Low Water Solubility of NPs 1126.4.6 Agglomeration/Aggregation of NPs 1126.5 Assessment of Toxicity of Nanoparticles 1126.5.1 In-Vitro Toxicity Assay Method 1126.5.2 In-Vivo Toxicity Assay Method 1146.5.2.1 Histopathological Analysis 1146.5.2.2 Blood Chemistry Analysis 1156.5.2.3 Immunotoxicity Assessment 1166.5.2.4 Genotoxicity Testing 1176.5.2.5 Reproductive and Developmental Toxicity Studies 1186.5.2.6 Organ-Specific Toxicity Assessment 1186.5.2.7 Long-Term Exposure Studies 1196.5.2.8 Behavioral Studies 1206.5.2.9 Metabolomics and Proteomics 1216.6 Risk Management of NPS 1226.6.1 Identification of Hazards Caused by Nanomaterials 1246.6.2 Guidance on Available Methods for Risk Assessment of Nanomaterials 1256.6.3 (Q)SAR Models for Regulatory Assessment of Nanomaterial Risks 1256.6.4 Can AI Help in Risk Management of NPs 1286.6.4.1 Analyzing Data and Predictive Modeling 1296.6.4.2 Toxicity Prediction 1306.6.4.3 Environmental Impact Assessment (EIA) 1316.6.4.4 Regulatory Compliance 1326.7 Conclusion 134References 1347 Assessment of Risks Due to Nanoparticles in the Ecosystem 1397.1 Introduction 1397.1.1 Airborne Nanoparticles 1417.1.2 Waterborne Nanoparticles 1437.1.3 Nanoparticles in Soil 1447.2 What to Consider for Nanoparticle-Related Assessment of Risks to Ecosystem 1457.2.1 Identify and Characterize Properties of Nanoparticles of Concern 1457.2.2 Bioavailability, Uptake and Toxicity Assessment 1467.2.3 Exposure Assessment Fate and Transport of NP 1477.2.4 Ecological Effects and Risk Characterization 1477.2.5 Uncertainty and Variability 1487.2.6 Risk Management and Mitigation 1507.3 Monitoring and Surveillance 1537.3.1 Monitoring Strategies 1547.3.1.1 Remote Sensing 1547.3.1.2 Tracking Technologies 1557.3.1.3 Challenges and Considerations 1567.4 Stakeholder Engagement 1567.4.1 Government Agencies 1567.4.2 International Organizations 1577.4.3 Researchers and Scientists 1577.4.4 Health Professionals 1577.4.5 Industry 1577.4.6 Non-Governmental Organizations (NGOs) 1587.4.7 Consumers 1587.4.8 Media 1587.5 Concluding Remarks 158References 159Part II: Ethical Aspects 1638 Ethics Governance and Policies: Problems and Concerns 1658.1 Introduction 1658.2 How Does Ethics Pertain to Nanotechnology? 1678.2.1 Ethics and Nanotechnology in the Workplace 1718.3 Framework for Ethical Analysis of Nanotechnology 1728.3.1 Considerations for Framework 1728.3.2 Privacy 1758.3.3 Security Concerns 1768.3.4 Environmental Concerns 1778.4 Governance and Policies Based on Ethics 1788.4.1 Subjectivity 1788.4.2 Complexity 1798.4.3 Enforcement of Policy 1798.4.4 Evolution of Ethics and Ethical Dilemmas 1798.5 Problems and Challenges Faced in Addressing Ethical Concerns 1808.5.1 Complexity 1818.5.2 Subjectivity 1818.5.3 Cost and Resource Constraints 1828.5.4 Changing Landscapes 1828.5.5 Lack of Awareness, Education and Training 1838.5.6 Health and Environment-Related Challenges 1838.5.7 Organizational Ethics 1848.5.8 Legal and Regulatory Compliance 1848.6 Concluding Remarks 185References 1859 Bioethical Questions: Ethically Assessing Toxicology and Human Health 1879.1 Introduction 1879.2 Organizations Involved in Ethically Assessing Health Risks 1889.2.1 International Organizations 1889.2.1.1 World Health Organization (WHO) 1899.2.1.2 United Nations Office for Disaster Risk Reduction (UNDRR) 1899.2.1.3 International Risk Governance Council (IRGC) 1909.2.1.4 International Organization for Standardization (ISO) 1909.2.1.5 Environmental Protection Agency (epa) – USA 1909.2.1.6 Federal Emergency Management Agency (fema) – USA 1919.2.1.7 National Institute for Occupational Safety and Health (NIOSH) – USA 1919.2.1.8 European Food Safety Authority (EFSA) 1919.2.2 Financial and Economic Organizations 1929.2.3 Academic and Research Institutions 1929.2.4 Industry and Private Sector 1929.3 How to Assess Risk and Uncertainty 1929.3.1 Risk Assessment Frameworks 1939.3.2 Identification of Potential Hazards 1949.3.3 Exposure Assessment 1949.3.4 Toxicity Assessment 1949.3.5 Quantifying Uncertainty and Data Gaps 1949.3.6 Risk Management 1959.3.7 Ethical Considerations, Communication and Stakeholder Engagement 1969.4 Potential Human Health Impacts Due to Exposure to Nanoparticles 1969.5 Mitigation of NP-Related Environmental Concerns Affecting Health 1999.5.1 Monitoring and Assessment of Risk to Mitigate Effect of NPs 2009.5.2 Safe Nanoparticle Design and Practices to Mitigate Effect of NPs 2009.5.3 Environmental Remediation and Nano-Bioremediation to Mitigate Effect of NPs 2019.5.4 Education and Public Awareness to Mitigate Effects of Nanoparticles 2029.5.5 Regulation and Policies to Mitigate Effects of Nanoparticles 2029.6 Equitable Distribution of the Benefits of Nanotechnology 2039.7 How to Ensure Human Exposure to Nanoparticles and Informed Consent 2059.8 Regulatory Framework for Nanotechnology 2079.9 How to Tackle the Dual-Use Dilemma of Nanoproducts 2099.10 Ethical Boundaries of Privacy and Surveillance Regarding Nanotechnology 2109.11 Balancing Long-Term Effects and Precautionary Principle Pertaining to NPs 2129.12 Fostering Global Collaboration in Research, Regulation and Governance of Nanotechnology 2149.13 Concluding Remarks 217References 21810 Diseases and Virus Theranostics for Rewriting the Ethical Risk Management 22310.1 Introduction 22310.2 Theranostics in Disease and Virus Management 22410.3 Ethical Risk Management and Risk Rewriting 22510.3.1 Ethical Risk Management 22610.3.2 Rewriting Risk 22610.4 Some Notable Examples of Theranostic Approaches 22710.4.1 Theranostics for Cancer Treatment 22710.4.2 Theranostics for Infectious Disease Caused by Virus 22710.4.3 Theranostics for Neurological Disorders Caused by Virus 22810.4.4 Theranostics in Viral Neurological Diseases 23010.5 Integration of Theranostics with Ethical Management 23110.6 Concluding Remarks 233References 23311 COVID-19 Therapy and Vaccine: An Eye Opener to Risk and Ethics 23511.1 Introduction 23511.1.1 An Overview of COVID-19 and History of SARS-CoV- 2 23611.2 COVID-19 Therapies 23711.2.1 Overview of Early Treatments 23811.3 Vaccine Development and Science Behind COVID- 19 Vaccine 23911.3.1 mRNA Vaccine 23911.3.2 Vector-Based Vaccine 24011.3.3 Protein Subunit Vaccine 24111.4 Potential Harm and Risk Assessment of COVID‐ 19 Therapies and Vaccines 24211.4.1 Potential Harmful Effects of COVID-19 Therapies 24311.4.1.1 Adverse Drug Reactions 24311.4.1.2 Off-Label Use of Existing Medications 24411.4.2 Potential Harmful Effects of COVID-19 Vaccines 24411.4.2.1 Vaccine-Related Adverse Events 24411.4.2.2 Vaccine Hesitancy 24411.5 Ethical Considerations in Applying COVID-19 Therapies 24411.5.1 Resource Allocation and Fairness 24511.5.2 Ethical Guidance During COVID- 19 24511.6 Ethical Considerations in Using Vaccine 24511.6.1 COVID-19 Vaccine Allocation Principles 24611.6.2 Informed Consent 24711.6.3 Equitable Distribution/Access 24811.6.4 Ethics of Balancing Vaccine Mandates with Public Health 24811.6.5 Transparent Communication 24911.6.6 Data Privacy 24911.6.6.1 The Dilemma: Public Health vs. Personal Privacy 24911.6.6.2 Stricter Data Protection Regulations 25011.6.6.3 Balancing Privacy and Health Protection 25011.6.6.4 Legal Guidance and Privacy Laws 25011.6.7 Risk Mitigation Strategies 25011.6.7.1 Some Case Studies in Ethics 25011.7 Role of Nanotechnology in COVID Therapy and Vaccine 25111.7.1 Nanotechnology in COVID-19 Vaccines 25111.7.2 Nanotechnology in COVID-19 Therapy 25211.7.3 Nanotechnology in COVID-19 Diagnostics 25211.7.4 Nanotechnology in Immune Modulation for Covid- 19 25211.7.5 Nanotechnology in Antiviral Personal Protective Equipment 25211.8 Conclusion 253References 25312 Social Ethics, Issues, and Anthropological Questions and Uncertainties in ID Detection 25712.1 Introduction 25712.2 Social Ethics and Nanotechnology 25812.2.1 Health Safety Risks and Social Ethics Due to Nanotoxicity 25912.2.2 Environmental Impact of Nanomaterial Causing Ecological Risks and Concern for Social Ethics 25912.2.3 Privacy and Nano-Surveillance Related to Social Ethics 26012.2.4 Social Inequality: Access to Benefits of Nanotechnology Related to Social Ethics 26012.2.5 Economic and Employment Disruption or Job Displacement Due to Monopolization of Knowledge About Nanotechnology 26112.2.6 Nano-Related Regulation and Governance Encompassing Regulatory Oversight 26212.2.6.1 Regulatory Oversight at the National and Regional Level 26212.2.6.2 Challenges in Global Standardization 26312.2.6.3 Potential Pathways for Global Governance 26412.2.7 Nanotechnology Led Human Enhancement: Ethical Dilemmas in Human Augmentation 26412.2.7.1 Nanotechnology and Human Enhancement 26512.2.7.2 Ethical Implications for Identity and Personhood 26512.2.8 Nano-Weaponization and Dual-Use Dilemmas in Military and Security: An Ethical Concern 26612.2.8.1 Nano-Weaponization 26612.2.8.2 Dual-Use Dilemma 26612.2.8.3 Ethical Concerns 26712.2.8.4 Possible Solutions and Ethical Guidelines 26812.3 Anthropological Questions Pertaining to Nanotechnology 26812.4 Uncertainties in Detection (ID Detection) Concerning Nanotechnology 26912.5 Conclusion 273References 274Epilogue 277Index 289