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E-raamat: Advancing the Framework for Assessing Causality of Health and Welfare Effects to Inform National Ambient Air Quality Standard Reviews

  • Formaat: 186 pages
  • Ilmumisaeg: 21-Dec-2022
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309690140
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  • Formaat: 186 pages
  • Ilmumisaeg: 21-Dec-2022
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309690140

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As part of its responsibilities under the Clean Air Act, the U.S. Environmental Protection Agency sets National Ambient Air Quality Standards (NAAQS) for the air pollutants carbon monoxide, lead, oxides of nitrogen, particulate matter, ozone, and sulfur dioxide. EPA uses a "weight of evidence approach" to evaluate evidence from scientific studies and describe the causal relationships between these "criteria pollutants" and any adverse impacts on human health and on public welfare - including impacts on wildlife, water, forests, agriculture, and climate. The evaluation, called an Integrated Science Assessment, is used to inform standards setting associated with the criteria pollutants.



This report, produced at the request of EPA, describes EPAs and several other frameworks for inferring causality of health or welfare effects and the characteristics of evidence useful for forming a causal determination. The report concludes that EPAs causal framework is effective, reliable, and scientifically defensible, provided that key scientific questions are identified and a range of necessary expertise is engaged. More transparency in how EPA integrates evidence could improve confidence in their determinations, and more guidance is needed in the framework on how evidence should be examined for vulnerable groups (e.g., human sub-populations) and sensitive ecosystems or species.

Table of Contents



Front Matter Summary 1 Introduction 2 Historical and Legal Perspectives on the NAAQS Framework for Assessing Causality 3 Definition of Causality 4 Influence of the Individual Study on the Body of Evidence 5 Evidence Synthesis in Integrated Science Assessments 6 Example Critiques of the ISA Process and Causal Determination Framework 7 Illustrative Frameworks for Causal Determinations 8 Emerging Methods for Observational Studies Contributing to Causal Determinations 9 Use of the Framework to Assess Both Health and Welfare Effects 10 Conclusions and Recommendations References Appendix A: Committee Member Biographies Appendix B: Open Session Agendas Appendix C: Introduction to Causal Inference Principles
Summary 1(10)
1 Introduction
11(10)
Statement of Task
12(1)
Committee Composition
12(1)
Interpretation of Task and Study Boundaries
13(3)
Causal Determinations
16(1)
Committee Information Gathering
17(2)
Report Organization
19(2)
2 Historical And Legal Perspectives On The Naaqs Framework For Assessing Causality
21(6)
Legal Background for the NAAQS
21(2)
Historical Perspective on the 2015 Preamble Framework
23(4)
3 Definition Of Causality
27(8)
Defining Causal Effects: Potential Outcomes
28(2)
Definition of "Cause" from the Preamble
30(1)
Evaluating Causality Through Mechanistic Understanding
30(1)
Causal Models
31(3)
Manipulative Causation
34(1)
4 Influence Of The Individual Study On The Body Of Evidence
35(12)
Study Selection and Evaluation in EPA's Causal Determination Framework
35(2)
Types of Evidence Used in Integrated Science Assessments to Support Causal Determinations
37(8)
Transparency, Reproducibility, and Replicability in Individual Studies
45(2)
5 Evidence Synthesis In Integrated Science Assessments
47(10)
Current Approach to Evidence Synthesis and Integration for Health Effects
47(1)
Integration and Synthesis Examples for Health Effects from the 2019 ISA for Particulate Matter and the 2020 ISA for Ozone
48(2)
Integration and Synthesis Examples for Health Effects from the 2020 Ozone ISA
50(1)
Current Approach to Evidence Synthesis and Integration for Welfare Effects
51(1)
Integration and Synthesis Examples for Welfare from the 2020 Ozone ISA
52(1)
Integration and Synthesis Examples from the 2020 NOx-SOx-PM ISA
53(2)
Evolution of the ISA Process Since Publication of the Preamble
55(2)
6 Example Critiques Of The Isa Process And Causal Determination Framework
57(10)
CASAC Comments from Recent ISA Reviews
57(2)
Critiques Related to the Weight of Evidence Approach
59(2)
Critiques Related to Systematic Review
61(2)
Critiques Related to the Causal Categories
63(1)
Critiques Related to Populations at Increased Risk and Selection of Endpoints
63(1)
Critiques Related to External Review
64(1)
Synthesis of Critiques and Reviews of the ISA Framework
65(2)
7 Illustrative Frameworks For Causal Determinations
67(34)
Preamble to the Integrated Science Assessments (ISAs) (2015a)
68(3)
Recent ISAs (2016-2020)
71(2)
Toxic Substances Control Act (TSCA)
73(3)
World Health Organization (WHO)
76(3)
Integrated Risk Information System (IRIS)
79(3)
Office of Health Assessment and Translation (OHAT)
82(4)
International Agency for Research on Cancer (IARC)
86(3)
E-Cigarettes
89(2)
United Nations Economic Commission for Europe (UNECE)
91(2)
Vaccines
93(3)
Canadian Smog Science Assessment (CSSA)
96(1)
Synthesis: What Might Be Useful in the ISA Causal Determination Framework
97(4)
8 Emerging Methods For Observational Studies Contributing To Causal Determinations
101(14)
Advances in Methods for Exposure Assessment
102(1)
Clarifying and Assessing the Validity of Causal Assumptions in Observational Studies
103(3)
Assessing the Quality of Individual Studies with Respect to Handling Measured Confounders
106(4)
Methods for Handling Unmeasured Confounders and Post-Treatment Variables
110(2)
Consideration of Multiple Exposures
112(2)
Examination of Variation in Effects
114(1)
9 Use Of The Framework To Assess Both Health And Welfare Effects
115(10)
Accounting for Different Characteristics of Causal Chains
115(6)
Adequacy and Effectiveness of the Current EPA Causal Determination Framework for Both Health and Welfare Standards
121(4)
10 Conclusions And Recommendations
125(12)
Improving the Single Causal Determination Framework for Health and Welfare Effects
127(1)
Study Quality Evaluation
128(4)
Integrating Evidence
132(1)
Expertise
133(1)
Concluding Thoughts
134(3)
References 137(16)
Appendixes
A Committee Member Biographies 153(6)
B Open Session Agendas 159(4)
C Introduction To Causal Inference Principles 163