Science and Decisions Advancing Risk Assessment (2009) / Chapter Skim
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Appendix C: Timeline of Selected Environmental Protection Agency Risk-Assessment Activities
Appendix C: Timeline of Selected Environmental Protection Agency Risk-Assessment Activities
Pages 283-298
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Appendix C Timeline of Selected Environmental Protection Agency Risk-Assessment Activities
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" Assessments of Suspected Carcinogens NRC 1983 Risk Seminal risk-assessment report that established the four organizing Assessment in the Federal principles for government risk efforts: hazard identification, doseGovernment: Managing the response assessment, exposure assessment, and risk characterization. Process Report also recommended that uniform inference guidelines be developed and that regulatory agencies take steps to establish and maintain a clear distinction between risk-assessment and risk management activities.
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. Definition of Risk Assessment: Risk assessment comprises hazard identification, dose-response assessment, exposure assessment, and risk characterization (NRC 1983)
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Characterization of potential adverse effects of exposures to hazards; includes estimates of risk and of uncertainties in measurements, analytic techniques, and interpretive models; quantitative risk assessment characterizes risk in numerical representations. EPA SAB 1990 Reducing Science Advisory Board peer review of 1987's Unfinished Business -- Risk: Setting Priorities "National policy affecting the environment must become more and Strategies for integrated and more focused on opportunities for environmental Environmental Protection improvement than it has been in the past.
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Second, two-stage models of carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that has resulted in the development of a mathematical dose-response model. EPA 1994a Guidance Given that there is no reference dose for lead, the EPA risk reduction Manual for the IEUBK goal for contaminated sites is to limit the probability of a child's blood Model for Lead in Children lead concentration exceeding 10 µg/dL to 5% or less after cleanup.
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Emphasizes the need for an iterative approach to risk assessment and makes recommendations for promoting clarity, comparability, and consistency in risk assessment. EPA 1996 Guidelines for Guidance provides principles and procedures to be used when Reproductive Toxicity Risk conducting risk assessments for reproductive toxicity.
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. EPA 1997c Guidance 1997 memorandum from Science Policy Council states: "This guidance on Cumulative Risk directs each office to take into account cumulative risk issues in Assessment -- Part 1, scoping and planning major risk assessments and to consider a broader Planning and Scoping scope that integrates multiple sources, effects, pathways, stressors and populations for cumulative risk analyses in all cases for which relevant data are available" (EPA 1997d)
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. EPA 2000b Risk Handbook provides a "single, centralized body of risk characterization Characterization: Science implementation guidance for Agency risk assessors and risk managers Policy Council Handbook to help make the risk characterization process transparent and the risk characterization products clear, consistent and reasonable" (EPA 2000b, p.
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A risk assessment comprises hazard identification, hazard characterization, exposure assessment, and risk characterization. EPA 2002b A Review of Provides comprehensive guidance on setting reference values and the Reference Dose and recommends different exposure metrics (subchronic and acute)
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research to improve the scientific foundation of human health risk assessment, including harmonizing cancer and noncancer risk assessments, assessing aggregate and cumulative risk, and determining risk to susceptible human subpopulations; and (2) research to enable evaluation of public-health outcomes of risk-management decisions.
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Issues Relevant to Risk Assessment EPA 2006a Child- Provides non-chemical-specific data on exposure factors for childhood Specific Exposure Factors age groups with respect to breast-milk ingestion, food ingestion, Handbook drinking-water ingestion, soil ingestion, hand-to-mouth and object to-mouth activity, such dermal exposure factors as surface areas and soil adherence, inhalation rates, duration and frequency in different locations and various microenvironments, duration and frequency of consumer-product use, and body weight. OMB 2006 Proposed Risk Was developed in an effort to "enhance the technical quality and Assessment Bulletin objectivity of risk assessments prepared by federal agencies by establishing uniform, minimum standards" (OMB 2006, p.
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(personal communication, EPA's Mary Jane Selgrade 12/15/06) EPA 2006b Framework for Emphasizes need to account for potential exposures to environmental Assessing Health Risks of agents during all stages of development and to consider relevant adverse Environmental Exposures health outcomes that may occur as a result of such exposures.
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1991a. Risk Assessment Guidance for Superfund: Volume I -- Human Health Evaluation Manual (Part B, Development of Risk-Based Preliminary Remediation Goals)
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1999. Risk Assessment Guidance for Superfund: Volume I -- Human Health Evaluation Manual Supplement to Part A: Community Involvement in Superfund Risk Assessments.
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2006b. Framework for Assessing Health Risks of Environmental Exposures to Children (External Review Draft)
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EPA SAB (U.S. Environmental Protection Agency Science Advisory Board)
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