Basic Information

Why does EPA have a Human Health Research Program?

EPA's Human Health Research Program, a core research effort, has been established to respond to legislative mandates that require the Agency to conduct research on human health. These mandates include the Food Quality Protection Act; Clean Air Act; Safe Drinking Water Act; Children's Health Act and Federal Insecticide; Fungicide, and Rodenticide Act.

The National Research Council recommended in its 1997 report, Building a Foundation for Sound Environmental Decisions, that to have an effective research program, EPA needed to maintain a balanced program of core and problem-driven research. Substantial efforts are made by ORD to build and maintain both core and problem-driven research programs that support one another.

Core or basic research provides the discoveries needed to generate new approaches to environmental problems that will reduce reliance on simplified approaches and assumptions in risk assessments.

What is the difference between core and problem-driven research?

As a regulatory agency, EPA's research must be results oriented and focused on the needs of its regulatory offices. Some research is required by law, whereas other research is initiated in response to specific environmental issues or opportunities. This research is directed to solving a specific problem or issue to prevent pollution or reduce its effects.

Research that is conducted to improve basic understanding of a scientific area is called core or basic research. Core research provides the methods, tools, and data that can be used to improve capabilities in other areas of science focused in solving specific problems.

Core and problem-driven research are not mutually exclusive. In fact, they are highly complementary and interactive, each informing the other as depicted in Figure 1. Fundamental research issues that cut across several areas often must be addressed before more problem-driven questions can be studied.

There is a constant need to integrate problem-driven and core research; some examples follow.

The Food Quality Protection Act of 1996 specifies that EPA will consider the risk associated with cumulative exposures of chemicals based on their modes of action. To develop predictive models of chemical interaction, fundamental research has to be done to identify the biological mode or mechanism of action to be used in the cumulative risk assessment.

A component of ORD's Human Health Research Program focuses on developing data on the biological processes that lead to health effects on major classes of environmental stressors. This data can be used to develop predictive models for risk assessment.

Another example of the need to link core and problem-driven research is that risk assessors are required to account for the unique susceptibilities of sensitive subpopulations in the risk assessment process. Part of ORD's Human Health Research Program focuses on identifying potential populations at risk and determining the extent to which their differential response to pollutants could influence the risk assessment process.

Figure 1. Human Health Research Program Is a Core Research Program

Adapted from Committee on Research Opportunities and Priorities for EPA,
Building a Foundation for Sound Environmental Decisions, NRC, 1997

How is the Human Health Research Program organized?

The research program is organized by the Risk Assessment and Risk Management Paradigm (Figure 2). This paradigm provides the structure by which environmental science is conducted in ORD.

The paradigm explains how risk assessment is conducted and supports risk management decisions. Human health risk assessment involves a qualitative and quantitative characterization of the relationship between environmental exposures and effects observed in exposed individuals and populations, whereas risk management concerns social, legal, economic, and other factors.

The National Research Council (1983) has described four primary steps in the process of risk assessment: (1) hazard identification, (2) dose-response assessment, (3) exposure assessment, and (4) risk characterization. Risk assessment is the primary scientific input to the risk management process.

Figure 2. Risk Assessment and Risk Management Paradigm

How is human health research implemented?

The Human Health Research Program is implemented using a strategic approach outlined in a multi-year plan (MYP). The MYP identifies specific performance goals and measures needed to achieve these goals over a 5- to 10-year period. The research themes in the plan were developed based on input from other offices in the Agency responsible for regulations and enforcement of standards. Input from the White House's Office of Management and Budget and outside peer reviewers, including the Board of Scientific Counselors (BOSC), also contribute to the development of the MYP.

Human health research is conducted by EPA's laboratories and centers in ORD and with the support of extramural grants, cooperative agreements, and interagency agreements.

What are the goals of the Human Health Research Program?

The multi-year plan for the Human Health Research Program has four major goals.

1. Biological (Mechanistic) Research. Human health research at EPA can save lives and reduce diseases by providing the knowledge needed to understand underlying biological processes that are triggered when individuals are exposed to environmental contaminants. This mechanistic information can be used to improve our understanding of potential risks to the public and advance EPA's ability to conduct risk assessments.
2. Susceptible Subpopulation Research. Human health research at EPA can protect the health of the nation's aging population, as well as children and those with heart disease, diabetes, asthma, and other chronic diseases, by providing new insights into how environmental pollutants may affect susceptible populations. These discoveries will lead to improved risk assessments to protect those most vulnerable.
3. Cumulative Risk Research. Human health research at EPA is providing clues to what happens to people when they are exposed to the many chemical mixtures in the environment. Assessing the cumulative risks posed by exposure to mixtures of pollutants is important to improving EPA's risk assessments to protect the public.
4. Tools for Risk Management Decisions. Human health research is providing the measurement tools and biological indicators needed to assess the impact of regulatory decisions on public health. The research will enable EPA to better evaluate public health outcomes and determine the effectiveness of actions to reduce health risks.

How is the Human Health Research Program evaluated?

The Human Health Research Program receives regular outside peer review from the BOSC. This panel of experts from academia, industry, and other organizations reviews the program for its relevance, quality, performance, and scientific leadership.

The review provides guidance that assists ORD to plan, implement, and strengthen the Human Health Research Program and make research investment decisions.

As part of a federal accountability effort, each of ORD's research areas including the Human Health Research Program, also undergoes review from the Office of Management and Budget.

How are human health research results used?

Clients for human health research are risk assessors in the Agency, States, other Federal agencies, international health organizations, and the regulated and academic communities. The stakeholders use the outputs from the Human Health Research Program to characterize risk. Progress is measured by the extent to which the program's methods, models, and data are used in peer-reviewed risk assessments.