Outline of Risk Assessment Training and Experience (RATE): Basic Understanding and Application of Risk Assessments

Transcription

1 Outline of Risk Assessment Training and Experience (RATE): Basic Understanding and Application of Risk Assessments Summary: Environmental risk Assessment 1 plays a unique role in serving the needs of various international programs through incorporating, integrating, and coordinating the use of scientific information as a foundation for regulatory decision-making. Risk assessment is an ever-evolving process that significantly impacts human health, food safety, economics, ecological systems, and social decision-making. The UnitedStates Environmental Protection Agency s (EPA s) National Center for Environmental Assessment (NCEA) is a global leader in conducting state-of-the-science risk assessments, and its publications are often the first to apply new Agency risk assessment guidelines, scientific methods, and data. This course will offer hands-on training in the primary areas of risk assessment (i.e., hazard identification, dose-response assessment, exposure assessment, and risk characterization). It also will briefly cover risk communication and management concepts because outreach to the public and other stakeholders is essential for the successful implementation of a risk assessment, and ultimately, an environmental decision. This training course will represent the culmination of knowledge-sharing among science experts in the field of human health and ecological risk assessment. The full day course consists of seven modules. Case studies demonstrating applications of risk assessment in different settings will also be discussed. Couse Objectives: This course will provide participants with: 1. An introduction to the fundamental concepts and terminology used in risk assessment (e.g., human health, ecological, and microbial risk assessements). 2. Information on how the risk assessment process is related to, and informs risk management policies. 1 For simplicity, the term environmental risk assessment is shortened to risk assessment in remainder of this document 1

2 3. Knowledge about the specific legal and regulatory underpinnings of the federal risk assessment paradigm, especially as they relate to the U.S. EPA and other federal agencies such as FDA and USDA. 4. An understanding of available human health and ecological toxicity values developed by the Federal government, state governments, and national and international associations. 5. In-depth knowledge about the fundamental components of a human health, ecological and microbial risk assessment, how they compare and contrast, and how their outcomes are integrated and applied in practice. 6. An understanding of the basic components of dose-response assessment and the differences between the current default approaches for developing risk and reference values for cancer and noncancer human health effects. 7. Training about how to apply scientific risk assessment to address environmental problems affecting air, soil, water, and food resources. Introduction: The United States Environmental Protection Agency among numerous organizations that utilize risk assessment as an approach to characterize the likelihood of risks to humans (e.g., residents, workers, susceptible populations, recreational visitors) and ecological receptors (e.g., birds, fish, wildlife, and habitat) from chemical, biological or physical stressors in the environment. Risk managers typically use this scientific information, along with other legal, social or economic information, to help best decide on a particular course of action affecting human health and the environment. Risk managers can be federal or state officials, business leaders, or private citizens or groups with the capacity to act at local, regional, national and/or international level. At EPA, environmental risk assessments typically fall into one of two areas: Human Health Risk Assessment, and Ecological Risk Assessment. A human health risk assessment is the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals in contaminated environmental media now, or in the future. To explain this better, a human health risk assessment addresses questions such as: What types of health problems may be caused by environmental stressors such as chemicals and radiation? What is the chance that people will experience health problems when exposed to different levels of environmental stressors? Is there a level below which some chemicals do not pose a human health risk? What environmental stressors are people exposed to, at what levels and for how long? Are some people more likely to be susceptible to environmental stressors because of factors such as age, genetics, pre-existing health conditions, ethnic practices, gender, etc.? Are some people more likely to be exposed to environmental stressors because of factors such as where they work, where they play, what they like to eat, etc.? The answers to these types of questions helps decision makers, whether they are parents or public officials, understand the possible human health risks from environmental media. 2

3 An ecological risk assessment is the process for evaluating how likely it is that the environment may be impacted as a result of exposure to one or more environmental stressors such as chemicals, land change, disease, invasive species or climate change. Every day, people face questions about environmental concerns, many of them related to plants, animals, ecosystems as a whole, and how we interact with them. These questions may be about potential risks such as impacts on the aesthetic value of a place due to physical alterations, effects of pollution on endangered species, or the consequences of long-term release of contaminants to an ecosystem. For example: How would the construction of a dam impact fish populations in nearby water bodies? Can the residential or agricultural application of an insecticide end up harming an endangered bird species? Do contaminants in the environment from an abandoned industrial or mining facility significantly reduce the use of the site and to nearby areas? What is the risk of introducing a non-native oyster to an estuary? How does fertilizer runoff reduce oxygen levels in water bodies such as bays? Are some plants or animals more likely to be susceptible to environmental stressors because of factors such as age, genetics, body size, or differences among species? A key part of EPA s mission is to understand the potential effects of stressors such as those described above and managing risks from them in order to protect the health of natural environments, human-modified landscapes, and the natural resources that people rely on. National Center for Environmental Assessment: EPA's National Center for Environmental Assessment (NCEA) is a leader in the science of human health and ecological risk assessment. The Center occupies a critical position in EPA s Office of Research and Development (ORD) between researchers in other parts of ORD and outside of EPA who are generating new findings and data, and the regulators in EPA s program and regional offices who must make regulatory, enforcement, and remedial action decisions. NCEA addresses the needs of stakeholders by preparing technical reports and assessments that integrate and evaluate the most up-to-date research. These products serve as a major component of the scientific foundation supporting EPA's regulations and policies. NCEA also conducts cutting-edge research to develop innovative quantitative risk assessment methods and tools that help extrapolate between experimental data and real-world scenarios, improve our understanding of uncertainties, and facilitate careful weighing of evidence. NCEA is also often called upon to help evaluate the effects of contaminant exposures during natural disasters, man-made events, and other population impact situations. 3

4 Outline of the Training Modules: Module-1: Developement and Overview of Current Regulatory and Advisory Values The objectives of this module is to provide participants with an overview of available reference toxicity values developed by the U.S. government, state governments in America, plus other national and international organizations. Governmental organizations specifically covered include the Environmental Protection Agency (EPA), American Conference of Governmental and Industrial Hygienists (ACGIH), American Industrial Health Association (AIHA), National Institute of Occupational Safety and Health (NIOSH), and Occupational Safety and Health Administration (OSHA). The general development, application, and enforcement of these values will also be discussed. The development of toxicity values will be presented within three different application contexts: Emergency, Occupational, and General Public. Overall Learning Objective: Understand the purpose of reference values developed by EPA and other organizations, identify the types of guidelines and standards derived by EPA and other entities, and describe the context and application of guidelines and standards. - Understand the general definition of reference values and how they are expressed. - Identify the key contexts in which reference values are developed and applied. - Understand the components needed to develop a reference value for a program-level or site-specific application. - Distinguish between the levels of enforceability for different reference values. - Identify the types of entities that develop reference values. - Understand how entities use/apply reference values in emergency response, occupational, and general public contexts. - Identify key examples of reference values and discuss the purpose and context of each. For EPA in particular, note how Integrated Risk Information System (IRIS) values are used by EPA s Program Offices and Regional Offices with exposure specifications to characterize risk and develop risk-management decisions. Module-2: Overview of Human Health and Ecological Risk Assessment Overall Learning Objective: Understand in greater depth the fundamental components of human health, ecological, and microbial risk assessments. Understand human health, ecological and microbial risk assessments compare and contrast. Understand how the outcomes of these processes are used in making risk management decisions. - Understand the components of risk assessment as recognized by the National Research Council (NRC) and EPA, and how they apply specifically to human health, ecological, and microbial risk assessments as conducted by EPA and NCEA - Problem formulation 4

5 - Hazard identification - Dose-response assessment - Exposure assessment - Risk characterization - Understand the types of data used to inform the different components of risk assessment and how they are used - Understand what risk assessment is and what it is not in the context of environmental decision-making Module-3: Overview of IRIS Human Health Effect Reference and Risk Values Overall Learning Objective: Gain knowledge of the meaning, development, and application of cancer and noncancer health risk and reference values derived by EPA and other entities. - Understand the basic components of dose-response assessment - Understand the differences between the current default approaches for developing risk and reference values for cancer and noncancer human health effects - Understand the role of key events and pathogenesis in dose-response assessment for noncancer or cancer endpoints Module-4: Overview of the IRIS Assessment Development Process Overall Learning Objective: Understand the components of an IRIS assessment and the process used to develop an IRIS assessment based on the current IRIS Standard Operating Procedures. - Explain the internal and external steps in the process of developing an IRIS assessment, including documents required in each step. - Identify and become familiar with the Toxicological Review, the organization of the principal supporting document for IRIS assessments. Students will learn how to: - Develop the supporting literature database - Select, report, and summarize key studies - Select the principal study or studies - Approach quantitative evaluation of data - Consider uncertainties - Assess confidence for IRIS assessments 5

6 Module-5: Overview of Major Risk Assessment Guidance Documents Overall Learning Objective: Understand the role of primary guidance documents for conducting human health, ecological and microbial risk assessments. - Identify primary guidance documents for hazard identification and dose-response assessment, including those that explain how - Toxicity values are derived - Principal studies and critical effects are identified - Point of departure is determined - Extrapolation is conducted - Uncertainty factors are identified - Identify primary guidance documents for exposure assessment - Identify primary guidance documents for risk characterization Module-6: General Concepts of Exposure Assessment - How exposure assessment relates to human health risk assessment - Important elements of exposure assessment - How to handle uncertainty and variability in exposure assessment - What EPA resources are available for exposure assessors 6

7 The Trainers: Reeder Sams Dr. Reeder L. Sams II is the Deputy Director (acting) of the Research Triangle Park (RTP) Division of the National Center for Environmental Assessment (NCEA) within the United States Environmental Protection Agency (USEPA). He has 20 years of experience in toxicology and risk assessment for the protection of public health. Dr. Sams is the project lead of a group of NCEA scientists to develop a state-of-the-art assessment for inorganic arsenic including recommendations from the National Academy of Sciences. This effort is in direct response to Congressional requests. Also, he is one of the primary leads for the development of risk assessment training within NCEA and has worked collaboratively with the Interstate Technology and Regulatory Council (ITRC) to develop training courses state and local organizations within the United States. Internationally, he has participated in the development / review of human health-related documents including International Agency for Research on Cancer (IARC) monographs (Monograph 100C) and the World Health Organization (WHO)/International Programme on Chemical Safety (IPCS) Guidance for Immunotoxicity Risk Assessment for Chemicals. Dr. Sams has contributed to and led the development of over 34 human health risk assessments or related documents including peer-reviewed journal articles and is a strong believer in risk assessment education 7

8 Michael Troyer Dr. Michael Troyer is the acting Deputy Director for the U.S Environmental Protection Agency s National Center for Environmental Assessment in Cincinnati, Ohio, USA. Michael began his career with the Agency in Washington, DC where he managed the scientific review of Agency regulations and policies, assessed the impacts of legislation on EPA s research efforts, and assisted in planning for the scientific needs of EPA s program and regional offices. Michael has served the Agency as an Ecologist and Supervisory Physical Scientist for over 23 years producing ecological and human health assessments pertaining to pesticides and toxics, hazardous waste sites, watersheds, wetlands, migratory birds, and endangered species. Michael holds a Bachelors degree in Zoology from DePauw University and two Masters degrees from Indiana University in Environmental Science, and Environmental Management and Policy. He also holds a PhD in Physical Geography from the University of Cincinnati. Michael s scientific interests and publications focus on topics ranging from risk assessment and management, to GIS and remote sensing, and understanding causation and change found in human-shaped landscapes (e.g., cultural and ecological relations). Training Material: An electronic copy of the training material will be provided to the participants free of charge. In addition, an electronic copy of each of the following documents will be provided to the participants free of charge: Exposure Factor Handbook Child-Specific Exposure Factors Handbook Wildlife Exposure Factors Handbook Microbial Risk Assessment Guidelines for Ecological Risk Assessment Generic Ecological Assessment Endpoints for Ecological Risk Assessment Stressor Identification Guidance Document 8