Risk Assessment for Environmental Health

Cover
Half Title
Title Page
Copyright Page
Dedication
Table of Contents
List of Boxes
Foreword
Preface
Editors
Contributors
Chapter 1: Introduction to Risk Assessment
Literatures Cited
Chapter 2: The Risk Assessment–Risk Management Paradigm
Definition of Risk
Historical Perspectives
The Red Book
The Objectives of Risk Assessment: Statutes and Programs
Biological End Points
A Framework for Regulatory Decision-Making
Adding Context for Risk Assessments
The Risk Commission
Special Challenges for Risk Assessment of Chemicals
Data and Testing
Extrapolation
Variation and Uncertainty
Emerging Areas in Chemical Risk Assessment
Contributions from All Public Health Sciences to Eco-Genetics and Risk Assessment
Risk Management–Risk Communication Approaches (See Chapter 17)
Thought Questions
Note
References
Chapter 3: Risk Assessment and Regulatory Decision-Making in Environmental Health
Introduction
Food Constituents and Contaminants
Food Safety History: Origins of Federal Food Laws
A Brief Summary of Food Safety Risk Assessment
The Modern Food Supply
Food Additives: The Example of Non-nutritive Sweeteners
GRAS Substances
Veterinary Drug Residues
Substances Formed by Processing
Crop Protection Chemicals
Food Contaminants of Industrial Origin – The Organics
Heavy Metals – Food Contaminants of Industrial and Natural Origin
Food Allergies and Intolerances
Mycotoxins
Microbial Pathogens
Genetically Modified Organisms, Agricultural Biotechnology, and Food Safety
Future Directions
References
Chapter 4: Exposure Assessment: The Ways We Measure Exposure and Its Application to Risk Assessment
Introduction
Basic Concepts and Key Components of Exposure Assessment
Exposure
Exposure Assessment
Dose
Role of Exposure Assessment in Risk Assessment
Overview of the Exposure Assessment Process
Step 1. Planning, Scoping, and Problem Formulation
Step 2. Exposure Setting Characterization
Step 3. Exposure Pathway Identification
Step 4. Exposure Quantification
Step 5. Uncertainty Assessment and Exposure Assessment Summary
Approaches in Assessing and Quantifying the Exposure
Direct Measurements Point-of-Contact Method
Indirect Estimation – Scenario Evaluation
Exposure Reconstruction – Biomonitoring and Reverse Dosimetry
Apply Exposure Assessment to Estimate Risk
References
Chapter 5: Biological Monitoring of Exposure to Environmental Chemicals throughout the Life Stages: Requirements and Issues to Consider for Birth Cohort Studies
Introduction
Exposure Assessment Methods and Their Uses
Questionnaires and Ecologic Measures
Direct Environmental Measurements
Biological Monitoring or Biomonitoring
Exposure Modeling
Biomonitoring and the Toxicokinetic Process of Environmental Chemicals
The General Behavior of Chemicals in the Body
Behavior of Specific Chemical Classes in the Body
Assessing Exposure Throughout the Life Cycle
Biological Matrices for Exposure Assessment
Blood or Blood Products (i.e., Plasma or Serum)
Urine
Breast Milk and Adipose Tissue
Alternative Matrices
Exposure Measurement Considerations
Biomolecular Adducts
Sampling Time Frame
Collecting Samples from Infants and Children
Temporal Variability in Urine and Blood Samples
Chemical Analysis Methods
Organic Chemicals
Heavy Metals and Metalloids
Measurement Method Specificity and Sensitivity Requirements
Quality Assurance and Control
Conclusion
Thought Questions
Literature Cited
References
Chapter 6: Role of Epidemiology in Environmental Health Research
Definition of Environmental Epidemiology
How Epidemiology Addresses Environmental Health Problems
Spatial Analysis in Environmental Epidemiology
Biomarkers in Environmental Epidemiology
Addressing Environmental Health Effects of Disasters
The Exposome
Conclusions
Appendix
References
Chapter 7: Toxicological Basis for Risk Assessment
References and Further Reading
Chapter 8: The Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Risk Assessment
Introduction: The Need for PBPK Modeling in Risk Assessment
What Is PBPK?
Differences between Classical Pharmacokinetic Models and PBPK Models
Conceptual Model: Graphical Representation
Mathematical Model: Mass Balance Differential Equations
A Priori Prediction vs. Curve Fitting
Biological Relevance
How Does a PBPK Model Work?
PBPK Modeling
Data Requirements for PBPK Modeling
Data Sets Used for Model Building and Model Validation
Available Software Comparison
Explanation of an Example of Computer Code for a PBPK Model in Berkeley Madonna
Numerical Integration
Sensitivity and Uncertainty
Sensitivity Analysis
Uncertainty Analysis
PBPK Models for Chemical Interactions (Multiple Chemical Interactive PBPK Models) in Chemical Mixtures
An Example of Application of PBPK Modeling in Dichloromethane Risk Assessment and Its Recent Development in Bayesian Population Approach
The Potential Applications of AI to PBPK Modeling
Acknowledgments
References
Chapter 9: Adverse Outcomes Pathways (AOPs)
Introduction to Adverse Outcome Pathways
Basic Principles for the Development and Assessment of AOPs
Application of AOPs to Environmental Health Risk Assessment
Future Directions and Challenges
Literature Cited
Chapter 10: Epigenetics in Risk Assessment
Developmental Origins and Critical Periods of Epigenetic Effects
Interpreting Epigenetic Variation and Its Relation to the Environment
Assessing Epigenetics
Applying Epigenetics in Risk Assessment
Challenges and Opportunities in Using Epigenetics in Risk Assessment
Literature Cited
Chapter 11: Probabilistic Models for Characterizing Aggregate and Cumulative Risk
Introduction
Aggregate and Cumulative Risks
Basic Risk Assessment Equations for Cancer and Noncancer Assessments
Aggregate Assessment of Exposure and Risk
Cumulative Assessment of Exposure and Risk
Characterizing Aggregate and Cumulative Risks
Measurement Studies
Modeling Studies
Probabilistic Models for Characterizing Aggregate and Cumulative Risks
Probability and Probability Distributions
Probability and Risk Assessment
Common Probability Distributions in Risk Assessment
Probabilistic Models for Exposure and Risk Assessment
Scoping for Probabilistic Modeling
Fundamental Approach for Probabilistic Modeling
Critical Issues in Probabilistic Modeling
Thought Questions
Disclaimers
References
Chapter 12: Occupational Risk Assessment
Background
Acute Fatal and Nonfatal Injuries
Occupational Disease
Occupational Exposures
Assessing and Managing Workplace Risks: NIOSH, OSHA, and EPA
NIOSH
OSHA
Role of the EPA in Occupational Risk Management
Overview of Occupational Risk Assessment Methodology and Policy
Court Decisions Affecting Risk Assessment
The Mechanics of Occupational Risk Assessment
Dose-Response Analysis
Case Study: Methylene Chloride
Control of Hazards
Elimination
Substitution
Engineering Controls
Administrative Controls
Personal Protective Equipment
The Evolution of Industrial Hygiene and the Role of New Professionals
Emerging Hazards
Nanotechnology
Impact of Climate on Workers
New Industrial Processes
Exposure to Mixtures
Technological Change
Thought Questions
Disclaimers
References
Chapter 13: Children’s Environmental Health Risk Assessment
Introduction
Children’s Health in Risk Assessment
Hazard Identification
Toxicokinetics
Toxicodynamics
Dose Response
Exposure Assessment
Physiological Rates
Activity Patterns
Risk Characterization
Thought Questions: Phthalates and Children
Web Resources
Literature Cited
Chapter 14: Addressing the Limits of Risk Assessment by Focusing on Safer Alternatives Risk Assessment for Environmental Health
Introduction
Limits of the Risk-Based Approach
Overview
Limits of Risk Assessment as a Tool
Challenges When Integrated into Policy Decision-Making
Addressing the Limits of Risk Assessment
From a Risk Focus to One Based on Safer Solutions
Defining Alternatives Assessment
History of Alternatives Assessment
Frameworks for Alternatives Assessment and Core Components
Alternatives Assessment Frameworks
Alternatives Assessment Components
Hazard Assessment
Hazard Screening
Full Hazard Assessment Methods and Tools
Comparative Exposure Assessment
Other Life Cycle Impact Considerations
Research Gaps in Alternatives Assessment – a Role for Risk Assessors
Data Gaps in Hazard Assessment
NAMS in Alternatives Assessment
Addressing Uncertainty in NAMs and IATAs
Reducing Type I Uncertainties Related to the Input Data Used
Reducing Type 2 Uncertainties Related to Extrapolations Made
Example Uncertainty Analyses for Two Major Types of Uncertainties: Cyrene TM (CAS#53716-82-8)
Incorporating Toxicological Data and Exposure Information into the Design of Safer Alternatives
Conclusion
Additional Resources
References
Literature Cited
Chapter 15: How European Countries Approach Regulatory Risk Assessment
Introduction
Regulation of Hazardous Chemicals
The Elements of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation
Registration
Occupational Safety Rules
Joint Registration of Same Substances
Testing and Assessment Requirements
Evaluation
Examination of the Testing Proposals
The Compliance Check
Substance Evaluation
Authorization
Restriction
Allocation of Responsibilities and Administration of REACH
Status and Function of ECHA
Role of the European Commission
Role of Member States
Downstream Users
Submission of the Notification Documents and Decisions
Cosmetics
Medicinal Products for Human and Veterinary Use
Medical Devices
General Requirements for Risk Assessment
Selection of a Point of Departure
Extrapolation to Lower Risk Levels
Note
Further Reading
Chapter 16: Envirome Disorganization and Ecological Riskscapes: The Algal Bloom Epitome
Ecosystem Risk: Ecology-Environment Nexus
Ocean Health: Algal Bloom as Epitome of Ecosystem Health
On Phytoplankton and Algal Blooms: A Two-Faced Coin
Ocean Viruses, Algal Blooms, Carbon Cycling, and Climate Risk
Land-Ocean Interface, Carbon Dynamic Transition, and Eco-hydrologic Restoration
Systemic Risk Quantification: Complex Networks and Predictions
Geospatial Probabilistic Risk Assessment
Optimal Information Flow
Florida Bay Case Study
Planetary Health via Ecosystem Science and Engineering
Ecosystem Portfolio Risk Management
Synopsis and Perspectives
Acknowledgments
Literature Cited
Chapter 17: Risk Communication
The Relationship between Risk Communication, Risk Assessment, and Risk-Management Decision-Making
Current and Evolving Risk Communication Approaches
Legal and Regulatory Considerations
What Is Risk Communication?
Typology of Risk Communication
The Purpose(s) of Risk Communication
Risk Communication and Stakeholder Involvement
Audience and Stakeholder Considerations
Distinctions between Lay and Expert Opinions
NRC’s Committee on Risk Characterization
Principles of Effective Risk Communication
Goals and Objectives
Audiences and Concerns
Understanding Risk Perception and the Importance of Establishing Trust and Credibility
Issues in Explaining Risk and Designing Messages
Dealing with Uncertainty
Risk Comparisons
Thought Questions
References
Index