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Appendix C
Timeline of Selected Environmental Protection Agency Risk-Assessment Activities
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TABLE C-1 Timeline of Selected EPA Risk-Assessment Activities
Date and Title of Milestone
Commentsa
EPA 1976 Interim Procedures and Guidelines for Health Risk and Economic Impact Assessments of Suspected Carcinogens
First agency “inference” guidelines on cancer risk. “How likely is the risk to occur, and if it does occur, what are the consequences? How likely is an agent to be a human carcinogen? How much cancer might be produced by the agent if it remains unregulated?”
NRC 1983 Risk Assessment in the Federal Government: Managing the Process
Seminal risk-assessment report that established the four organizing principles for government risk efforts: hazard identification, dose-response assessment, exposure assessment, and risk characterization. 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.
Definition of Risk Assessment: characterization of potential adverse health effects of human exposure to environmental hazards.
EPA 1984 Risk Assessment and Management: Framework for Decision Making
EPA’s response to NRC (1983), Risk Assessment in the Federal Government: Managing the Process. Discusses EPA’s activities to address recommendations in the 1983 NRC report, including establishing the Risk Assessment Forum and efforts to develop six risk-assessment guidelines. Risk-management activities were expanded to include cost-effectiveness tools that could be used in risk management, the importance of strengthening communication in risk management, and risk-management principles, such as consistency of approach in making decisions. Prompted training program for EPA senior managers with emphasis on the distinction between risk-assessment and risk-management activities.
Definition of Risk Assessment: In simplest sense, population risks posed by toxic pollutants are a function of two measurable factors: hazard and exposure. To cause a risk, a chemical has to be both toxic (present as intrinsic hazard) and present in the human environment at some substantial level (provide opportunity for human exposure). Risk assessment interprets evidence on the two points, judging whether an adverse effect will occur and (if appropriate) making the necessary calculations to estimate the extent of total effects.
1984 Risk Assessment Forum Charter
In 1984, the Risk Assessment Forum (RAF) is established in response to an NRC (1983) recommendation “to promote consensus on risk assessment issues.” RAF convenes risk-assessment experts to study and report on risk-assessment issues. RAF has produced risk-assessment guidelines, technical panel reports on special risk-assessment issues, and peer-consultation and peer-review workshops (EPA 2002a).
OSTP 1985 Chemical Carcinogens: Review of the Science and Its Associated Principles
Report details 31 principles developed by interagency group for carcinogenicity evaluations in regulatory settings.
EPA 1986a Memorandum: Establishment of the Risk Assessment Council
The Risk Assessment Council is established in 1986 by Lee Thomas to “oversee virtually all aspects of the Agency’s risk assessment process, to identify issues and problems with that process” (EPA 1986a), and to ensure that EPA programs use risk assessment in a consistent and scientifically credible fashion.
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EPA 1986b Guidelines for Carcinogen Risk Assessment
The 1986 guidelines, developed to address an NRC (1983) recommendation to craft cancer inference guidelines, incorporate concepts and approaches established since the previous cancer guidelines were released in 1976.
EPA 1986c Guidelines for Mutagenicity Risk Assessment
The guidelines state that “a consistent approach to the evaluation of mutagenic risk from chemical substances arises from the authority conferred upon the Agency by a number of statutes to regulate potential mutagens” (EPA 1986c, p. 2).
Definition of Risk Assessment: Risk assessment comprises hazard identification, dose-response assessment, exposure assessment, and risk characterization (NRC 1983). Hazard identification is qualitative risk assessment, dealing with the inherent toxicity of a chemical substance. A qualitative mutagenicity assessment answers the question of how likely an agent is to be a human mutagen. The three remaining components constitute quantitative risk assessment, which provides a numerical estimate of the public-health consequences of exposure to an agent. The quantitative mutagenicity risk assessment deals with the question of how much mutational damage is likely to be produced by exposure to a given agent under particular exposure scenarios.
EPA 1986d Guidelines for Chemical Mixtures Risk Assessment
Details agency approaches to assessing risks posed by complex chemical mixtures with supplementary update in EPA (2000a).
EPA 1987 Unfinished Business: A Comparative Assessment of Environmental Problems
Assesses agency resource allocations relative to magnitude of risks and protection gained.
“Many new [environmental] problems are difficult to evaluate; many involve toxic chemicals that can cause cancer or birth defects at levels of exposure that are hard to detect; and many involve persistent contaminants that can move from one environment medium to another, causing further damage even after controls have been applied for one medium. The complexity and gravity of these issues make it particularly important that EPA apply its finite resources where they will have the greatest effect. Thus, the Administrator of EPA commissioned a special task force of senior career managers and technical experts to assist him and other policy makers in the task. The assignment was to compare the risks currently associated with major environmental problems” (EPA 1987, p. xiii).
EPA 1989 Risk Assessment Guidance for Superfund (RAGS)
Provides guidance on conducting site-specific risk assessments at Superfund sites. About four pages are devoted to planning and scoping. See EPA 1989 Risk Assessment Guidance for Superfund, Vol. 1—Human Health Evaluation Manual, Parts A-E; Baseline Assessment (EPA 1989), Community Involvement (EPA 1999); Preliminary Remediation Goals (EPA 1991a); Remedial Alternatives (EPA 1991b); Standardized Planning and Reporting, and Dermal Risk Assessment (EPA 2001).
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Commentsa
NRC 1989 Improving Risk Communication
Risk communication is a two-way process involving participation of and information exchange between the scientist and the public.
Definition of Risk Assessment: Generally refers to characterization of potential adverse effects of exposures to hazards.
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 Risk: Setting Priorities and Strategies for Environmental Protection
Science Advisory Board peer review of 1987’s Unfinished Business—“National policy affecting the environment must become more integrated and more focused on opportunities for environmental improvement than it has been in the past…. Integration in this case means that government agencies should assess the range of environmental problems of concern and then target protective efforts at the problems that seem to be the most serious…. The concept of environmental risk can help the nation develop environmental policies in a consistent and systematic way” (EPA SAB 1990, pp. 1-2).
1990 Amendments to the Clean Air Act
To expedite control of air toxics, Congress switches EPA’s approach from a risk-assessment–oriented program to a technology-oriented regulatory approach with a mandate to study “residual risks” posed by 189 air toxics 8 y after technology controls are put into place.
EPA 1991c Guidelines for Developmental Toxicity Risk Assessment
Guidelines outline principles and methods to characterize risks posed by environmental exposures during human development. They address relationship between maternal and developmental toxicity, characterization of health-related database for developmental-toxicity risk assessment, use of reference dose or reference concentration for developmental toxicity, and use of benchmark dose.
Definition of Risk Assessment: Process by which scientific judgments are made concerning the potential for toxicity to occur in humans.
EPA 1991d Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat
EPA’s Risk Assessment Forum is among first to describe animal tumors not found in humans; related volume on thyroid follicular-cell tumors is published in 1998.
EPA 1992a Guidance on Risk Characterization for Risk Managers and Risk Assessors
Agencywide guidance includes a statement of confidence about data and methods used to develop assessment; need to provide basis of greater consistency and comparability in risk assessments across agency programs; and role of professional scientific judgment in overall statement of risk.
EPA 1992b Developing a Work Scope for Ecological Assessments
Develops a framework for ecologic risk assessment. Describes process in detail and demonstrates how it could be applied to broad array of situations. Defines ecologic risk assessment as “a process that evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure, to one or more stressors” (EPA 1992b).
EPA 1992c Guidelines for Exposure Assessment
Guidelines, which pertain to both human and wildlife exposures to chemicals, provide general information on exposure assessment, including definitions and guidance on planning, conducting exposure-assessment studies, presenting results, and characterizing uncertainty. State that exposure estimates will be fully detailed in risk assessments, including assumptions, uncertainties, and rationale for each.
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EPA 1992d Dermal Exposure Assessment: Principles and Applications
Summarizes current state of knowledge regarding dermal exposure to water, soil, and vapors; presents methods for estimating dermal absorption stemming from contact with these media; and elaborates on their associated uncertainties. Focuses on evaluating exposures from waste-disposal sites or contaminated soils.
EPA 1993 Memorandum: Creation of a Science Policy Council
Science Policy Council (SPC) is created in 1993 to replace RAC and is chaired by assistant administrator for Office of Research and Development (ORD). It is tasked with an expanded mission to “implement and ensure the success of selected initiatives recommended by external advisory bodies such as the National Research Council and the Science Advisory Board, as well as others such as the Congress, industry and environmental groups, and Agency staff.” SPC has developed a number of guidance documents and policies for the agency.
NRC 1993a Pesticides in the Diets of Infants and Children
Concluded that children consume more air, water, and food on a body-weight basis than adults and engage in other behaviors that make them more susceptible to environmental exposures, including hand-to-mouth and object-to-mouth behaviors. The publication of this report is one of the factors that prompted the 1996 Food Quality Protection Act for pesticides.
NRC 1993b Issues in Risk Assessment
This report examines the scientific basis, inference assumptions, and regulatory uses o and research needs in risk assessment in two parts. First, use of maximum tolerated dose in animal bioassays for carcinogenicity addresses whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. 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 Manual for the IEUBK Model for Lead in Children
Given that there is no reference dose for lead, the EPA risk reduction goal for contaminated sites is to limit the probability of a child’s blood lead concentration exceeding 10 µg/dL to 5% or less after cleanup. Blood lead concentration can be correlated with exposure and adverse health effects. The Integrated Exposure Uptake Biokinetic Model for Lead in Children is used to predict blood lead concentration and the probability of a child’s blood lead concentration exceeding 10 µg/dL, considering a multimedia exposure scenario and toxicokinetics.
NRC 1994 Science and Judgment in Risk Assessment
Report makes a variety of recommendations to EPA, many directed at the Office of Air and Radiation, including that EPA explicitly identify each use of a default option in risk assessments, the agency should conduct quantitative analyses of uncertainty, that risk managers be given characterizations of risk that are both qualitative and quantitative, and that EPA make uncertainties explicit and present them as accurately and fully as is feasible and needed for risk-management decision-making.
Definition of Risk Assessment: Risk assessment entails evaluation of information on the hazardous properties of substances, on the extent of human exposure to them, and on the characterization of the resulting risk. Risk assessment is not a single, fixed method of analysis. Rather, it is a systematic approach to organizing and analyzing scientific knowledge and information on potentially hazardous activities or on substances that might pose risks under specified conditions. In brief, according to the Red Book, risk assessment can be divided into four steps: hazard identification, dose-response assessment, exposure assessment, and risk characterization.
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EPA 1994b Interim Methods for Development of Inhalation Reference Concentrations (RfCs)
Provides guidance on how to model lung dosimetry across species for setting RfCs. The method includes consideration of respiratory anatomy, physiochemical properties of the agent, and portal-of-entry considerations, such as comparative pulmonary toxicity.
EPA 1994c Report of the Agency Task Force on Environmental Regulatory Modeling: Guidance, Support Needs, Draft Criteria and Charter
The report concludes that there is a need for training, additional technical support, and agency guidance on external peer review of environmental regulatory modeling, among others.
EPA 1995 Memorandum: Policy for Risk Characterization at the U.S. Environmental Protection Agency
Reaffirms the principles and guidance in the agency’s 1992 policy (Guidance on Risk Characterization for Risk Managers and Risk Assessors). The policy statement and associated guidance were designed to “ensure that critical information from each stage of a risk assessment is used in forming conclusions about risk and that this information is communicated from risk assessors to risk managers (policy makers), from middle to upper management, and from the Agency to the public” (EPA 1995, p. 1). Policy and guidance discuss key aspects of risk characterization, including the need to bridge risk assessment and risk management, discuss confidence and uncertainties in data, and present several types of risk information. 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 Reproductive Toxicity Risk Assessment
Guidance provides principles and procedures to be used when conducting risk assessments for reproductive toxicity.
1996 Passage of Food Quality Protection Act (FQPA)
Modernizes pesticide risk assessment by requiring accelerated licensing reviews, consideration of aggregate pesticide exposure (drinking water, residential, lawn, and food uses), and sophisticated analysis and regulation of cumulative risk of chemicals that share a mode of toxic action. In addition, mandates developing screens for potential “endocrine disruptors.” FQPA also requires EPA to invoke an additional safety factor of 2-10 to account for children’s risks in regulating pesticides when data are lacking.
1996 Passage of Safe Drinking Water Act amendments
Requires explicit consideration of susceptible subpopulations in setting maximum contaminant levels for drinking-water pollutants in addition to consideration of technical feasibility and costs. SDWA mandates “endocrine disruptor” screens and tests.
NRC 1996 Understanding Risk: Informing Decisions in a Democratic Society
Recommends that risk characterization be a “decision-driven activity, directed toward informing choices and solving problems” (NRC 1996, p. 155). Also recommends a focus on problem formulation during the initial stages of risk-assessment planning.
EPA 1997a Guiding Principles for Monte Carlo Analysis
Documents EPA’s position “that such probabilistic analysis techniques as Monte Carlo analysis, given adequate supporting data and credible assumptions, can be viable statistical tools for analyzing variability and uncertainty in risk assessments” (EPA 1997a, p. 1) and presents an initial set of principles to guide the agency in using probabilistic analysis tools.
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EPA 1997b Policy for Use of Probabilistic Analysis in Risk Assessment at the U.S. Environmental Protection Agency
Includes guiding principles to support the use of various techniques for characterizing variability and uncertainty and defines eight conditions for acceptance. The conditions are required “for ensuring good scientific practice in quantifying uncertainty and variability” (EPA 1997b, p. 1).
PCCRARM 1997a Framework for Environmental Health Risk Management—Volume 1
The commission was tasked under Section 303 of the Clean Air Act Amendments of 1990 to investigate the policy implications and appropriate uses of risk assessment and risk management in regulatory programs.
PCCRARM 1997b Risk Assessment and Risk Management in Regulatory Decision-Making—Volume 2
The Commission on Risk Assessment and Risk Management helped to stimulate agency policies, legislation, and private-sector activities that improved risk assessment and risk management. Commission’s recommendations are cited in EPA policy changes on probabilistic analysis, risk characterization, and cumulative risk. The Food Quality Protection Act and the Safe Drinking Water Act Amendments of 1996 reflect commission proposals.
“To make an effective risk management decision, risk managers and other stakeholders need to know what potential harm a situation poses and how great is the likelihood that people or the environment will be harmed. Gathering and analyzing this information is referred to as risk assessment. The nature, extent, and focus of a risk assessment should be guided by the risk management goals” (PCCRARM 1997b, p. 19). “For this reason, the Commission recommends that a risk assessment characterize the scientific aspects of a risk and note its subjective, cultural, and comparative dimensions [see “How Should Risks Be Analyzed?” on page 24]. While this expands risk assessment beyond its traditional, more narrowly scientific scope, including these additional dimensions will help educate all stakeholders about key factors affecting the perception of risk” (p. 21).
EPA 1997c Guidance on Cumulative Risk Assessment—Part 1, Planning and Scoping
1997 memorandum from Science Policy Council states: “This guidance directs each office to take into account cumulative risk issues in scoping and planning major risk assessments and to consider a broader 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).
EPA 1997e Exposure Factors Handbook
The purposes of the handbook are to: “(1) summarize data on human behaviors and characteristics which affect exposure to environmental contaminants, and (2) recommend values to use for these factors” (EPA 1997e, p. 1).
Executive Order 13045 1997 Protection of Children From Environmental Health Risks and Safety Risks
Primary directive to federal agencies and departments to “make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children.” States that those agencies should “ensure that policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks” [Sec. 1-101(a)(b)]. Establishes Task Force on Environmental Health Risks and Safety Risks to Children.
EPA 1998a Guidelines for Neurotoxicity Risk Assessment
Guidelines provide principles and procedures for evaluating neurotoxic risks due to chemical exposures.
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EPA 1998b Guidelines for Ecological Risk Assessment
Guidelines incorporate slight modifications to the process described in 1992 (Developing a Work Scope for Ecological Assessments). They emphasize the importance of problem formulation in the risk-assessment process as recommended in the 1996 NRC report Understanding Risk. They state: “During planning, risk managers and risk assessors are responsible for coming to agreement on the goals, scope, and timing of a risk assessment and the resources that are available and necessary to achieve the goals. Together they use information on the area’s ecosystems, regulatory requirements, and publicly perceived environmental values to interpret the goals for use in the ecological risk assessment…. The characteristics of an ecological risk assessment are directly determined by agreements reached by risk managers and risk assessors during planning dialogues. These agreements are the products of planning. They include (1) clearly established and articulated management goals, (2) characterization of decisions to be made within the context of the management goals, and (3) agreement on the scope, complexity, and focus of the risk assessment, including the expected output and the technical and financial support available to complete it” (EPA 1998b, pp. 13-15). Guidelines state that many of the difficulties with risk assessment can be traced back to issues with problem formulation.
Successful ecologic risk assessment is more likely if there is an up-front discussion of what is at risk, what the assessment end points are, how they are measured, and what constitutes unacceptable risk.
NSTC 1999 Ecological Risk Assessment in the Federal Government
Developed by interagency work group under auspices of Committee on Environment and Natural Resources to discuss major uses of ecologic risk assessment by federal agencies. The report discussed “examples of current ecological risk assessment areas (established uses), potential uses where components of ecological risk assessment are used, and related ecological assessments and other scientific evaluations that might benefit from the use of ecological risk assessment methodologies. Recommendations were made to improve the science, enhance information transfer, and improve risk management coordination” (NSTC 1999, p. 10-5).
EPA 2000b Risk Characterization: Science Policy Council Handbook
Handbook provides a “single, centralized body of risk characterization implementation guidance for Agency risk assessors and risk managers to help make the risk characterization process transparent and the risk characterization products clear, consistent and reasonable” (EPA 2000b, p. vii). It implements EPA’s 1992a Guidance on Risk Characterization for Risk Managers and Risk Assessors and its 1995 Policy for Risk Characterization. The handbook emphasizes the need for planning in the risk assessment process and clearly displaying all relevant information and policy choices, and it reinforces general guidance on variability and uncertainty, including distinguishing between them.
EPA 2000c Benchmark Dose Technical Guidance Document
Provides guidance on the “application of the benchmark dose approach to determining the point of departure (POD) for linear or nonlinear extrapolation of health effects data. Guidance discusses computation of benchmark doses and benchmark concentrations (BMDs and BMCs) and their lower confidence limits, data requirements, dose-response analysis, and reporting requirements” (EPA 2000c, p.1). Guidance provides an alternative to reliance on no-observed-adverse-effect levels as a POD.
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EPA SAB 2000 Toward Integrated Environmental Decision-Making
Effort by EPA’s SAB. Attempt at integrating ecology, human health, and economic valuation to develop holistic assessments.
EC 2000 First Report on the Harmonisation of Risk Assessment Procedures
Report of the Scientific Steering Committee Working Group on Harmonisation of Risk Assessment Procedures in the Scientific Committees advising the European Commission in human and environmental health.
Definition of Risk Assessment: Process of evaluation that includes identification of attendant uncertainties, of the likelihood and severity of adverse effects/or events occurring in humans or the environment after exposure under defined conditions to a risk sources. A risk assessment comprises hazard identification, hazard characterization, exposure assessment, and risk characterization.
EPA 2002b A Review of the Reference Dose and Reference Concentration Processes
Provides comprehensive guidance on setting reference values and recommends different exposure metrics (subchronic and acute) for IRIS.
OMB 2002 OMB Guidelines for Ensuring and Maximizing the Quality, Utility, and Integrity of Information Disseminated by Federal Agencies
Establishes governmentwide standards for the quality of data used and disseminated by the federal government. EPA releases its own guidelines for information quality based on OMB’s guidelines in same year (see below).
EPA 2002c Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency
Developed in response to OMB’s information-quality guidelines. EPA’s guidelines discuss EPA’s procedures developed for “ensuring and maximizing the quality of information [EPA] disseminate[s]” and “administrative mechanisms for EPA pre-dissemination review of information products” (EPA 2002c, p. 3).
EPA 2002d OSWER Draft Guidance for Evaluating the Vapor Intrusion to Indoor Air Pathway from Groundwater and Soils
“Vapor intrusion is the migration of volatile chemicals from the subsurface into overlying buildings. Volatile chemicals in buried wastes and/or contaminated groundwater can emit vapors that may migrate through subsurface solids and into air spaces of overlying buildings” (EPA 2002d, p. 4). “In extreme cases, the vapors may accumulate in dwellings or occupied buildings to levels that may pose near-term safety hazards… [or] acute health effects” (p. 5).
EPA 2003a A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information
Document was developed to “raise the awareness of the information-generating public about EPA’s ongoing interest in ensuring and enhancing the quality of information available for Agency use. Further, it complements the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (EPA Information Quality Guidelines). This summary of Agency practice is also an additional resource for Agency staff as they evaluate the quality and relevance of information, regardless of source” (EPA 2003a, p. iv).
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EPA 2003b Framework for Cumulative Risk Assessment
Framework was developed to provide a consistent approach to cumulative risk assessment and identifies basic elements of the process, including a flexible structure for conducting and evaluating cumulative risk assessments and providing definitions for key terms. It also describes the three main phases of cumulative risk assessment: planning, scoping, and problem formulation; analysis; and risk characterization. Discusses planning and scoping as one distinct activity and problem formulation as another.
EPA 2003c Human Health Research Strategy
Strategy presents a conceptual framework for human health research by ORD and includes two strategic research directions to be pursued over the next 5-10 y: (1) 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.
EPA 2004a Boron and Compounds
EPA’s IRIS assessment for boron and compounds is the first for an oral reference dose that includes a nondefault value for interspecies extrapolation and the first IRIS assessment that divides the uncertainty factor for intraspecies uncertainty (UFH) into toxicokinetic and toxicodynamic components; the assessment also develops a nondefault value for intraspecies variability (DeWoskin et al. 2007).
EPA 2004b An Examination of EPA Risk Assessment Principles and Practices
EPA staff paper that includes recommendations as to how EPA could strengthen and improve its risk-assessment practices.
Definition of Risk Assessment: Referring to the NRC Red Book, this document defines it as “a process in which information is analyzed to determine if an environmental hazard might cause harm to exposed persons and ecosystems” (EPA 2004b, p. 2).
EPA 2004c Air Toxics Risk Assessment Reference Library
Provides “descriptions of the major methods and technical tools that are commonly used to perform air toxics risk assessments. Specifically, the manual attempts to cover all the common basic technical approaches that are used to evaluate: how people in a particular place (e.g., a city or neighborhood) may be exposed; what chemicals they may be exposed to and at what levels; how toxic those chemicals are; and how likely it is that the exposures may result in adverse health outcomes. Topics include uncertainty and variability, basic toxicology and dose-response relationships, air toxics monitoring and modeling, emissions inventory development, multipathway risk assessment, and risk characterization” (EPA 2004c, Vol.1, Part 1, p. 1-5). It provides separate and extensive guidance on planning and scoping and on problem formulation and discusses them as distinct activities.
States that “planning and scoping may be the most important step in the risk assessment process. Without adequate planning, most risk assessments will not succeed in providing the type of information that risk management needs to make a well-founded decision” (EPA2004c, Vol. 1, Part 2, p. 5-9).
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EPA 2005a Guidelines for Carcinogen Risk Assessment
Revises cancer guidelines, inviting mechanistic data review and consideration of early-life exposures (mutagens trigger additional safety factors).
Does not discuss planning and scoping or problem formulation.
Definition of Risk Assessment: Page 1-3: Publications by the Office of Science and Technology (OSTP 1985) and the National Research Council (NRC 1983, 1994) provide information and general principles about risk assessment. Risk assessment uses available scientific information on the properties of an agent and its effects in biologic systems to provide an evaluation of the potential for harm as a consequence of environmental exposure. The 1983 and 1994 NRC documents organize risk-assessment information into hazard identification, dose-response assessment, exposure assessment, and risk characterization. This structure appears in these cancer guidelines, with additional emphasis on characterization of evidence and conclusions in each part of the assessment.
EPA 2005b Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities
The protocol is an “approach for conducting multi-pathway, site-specific human health risk assessments on Resource Conservation and Recovery Act hazardous waste combustors” (EPA 2005b, p. 1-1). Does not discuss planning and scoping or problem formulation.
Expansion of IRIS program
Planned expansion of the Integrated Risk Information System (IRIS) program with toxicity-assessment reviews to include broader input of federal partners, OMB, and other parties. (See Risk Policy Report 2005a,b)
EPA 2005c Aging and Toxic Response: Issues Relevant to Risk Assessment
Identifies data gaps and research needs to assist ORD in characterizing risks to the aging population from exposure to environmental toxicants.
EPA 2006a Child-Specific Exposure Factors Handbook
Provides non-chemical-specific data on exposure factors for childhood age groups with respect to breast-milk ingestion, food ingestion, 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 Assessment Bulletin
Was developed in an effort to “enhance the technical quality and objectivity of risk assessments prepared by federal agencies by establishing uniform, minimum standards” (OMB 2006, p. 3). Includes language related to conducting uncertainty analyses, seven standards for conducting general risk assessments, and nine special standards for influential risk assessments.
Definition of Risk Assessment: Risk assessment refers to a document that assembles and synthesizes scientific information to determine whether a potential hazard exists and/or the extent of possible risk to human health, safety, or environment.
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GAO 2006 Human Health Risk Assessmentg
GAO evaluated EPA’s progress in human risk assessment since release of the 1994 NRC report Science and Judgment. Indicates that EPA has strengthened its risk-assessment process by, for example, increasing planning for assessments, using new methods, developing guidance documents, improving its ability to characterize variability, and initiating steps to address cumulative risk. However, improvements are needed, including in the planning process, training for staff, and transparency in documenting analytic choices.
2006 EPA Changes to development of risk ranges for estimates in IRIS database
Office of Research and Development sets priorities for development of risk ranges for estimates in IRIS chemical risk value database to reflect uncertainty (see Risk Policy Report 2006a,b).
2006 European Parliament passes REACH legislation (Registration, Evaluation and Authorisation of Chemicals)
Sweeping new chemical regulation (REACH) places burden of assessing safety on industry for high-production-volume chemicals.
NRC 2007 Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget
Reviews OMB 2006 and recommends that it be withdrawn. One criticism concerned OMB’s definition of risk assessment as documents that synthesize science. Recommends reverting to NRC Red Book definition as a process involving hazard identification, dose-response assessment, exposure assessment, and risk characterization.
2006 EPA Immunotoxicity Guidelines, In development (personal communication, EPA’s Mary Jane Selgrade 12/15/06)
First-time effort will address challenging subject of immune-system biology and toxicants.
EPA 2006b Framework for Assessing Health Risks of Environmental Exposures to Children
Emphasizes need to account for potential exposures to environmental agents during all stages of development and to consider relevant adverse health outcomes that may occur as a result of such exposures.
EPA SAB 2007 Consultation on Enhancing Risk Assessment Practice and Updating EPA’s Exposure Guidance
The SAB recommends that the Agency “incrementally replace the current system of single-point uncertainty factors with a set of distributions, using probabilistic methods.”
aIncluded are definitions of risk assessment cited in the documents to illustrate the various definitions discussed in Chapter 3.
REFERENCES
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EC (European Commission). 2000. First Report on the Harmonisation of Risk Assessment Procedures [online]. Available: http://ec.europa.eu/food/fs/sc/ssc/out83_en.pdf [accessed June 3, 2007].
EPA (U.S. Environmental Protection Agency). 1976. Interim Procedures and Guidelines for Health Risk and Economic Impact Assessments of Suspected Carcinogens. U.S. Environmental Protection Agency, Washington, DC.
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EPA (U.S. Environmental Protection Agency). 1986b. Guidelines for Carcinogen Risk Assessment. EPA/630/R-00/004. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC [online]. Available: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=54933 [accessed June 3, 2007].
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