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Strategic Direction for New Pesticide Testing and Assessment Approaches

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To better protect human health and the environment, EPA is developing and evaluating new technologies in molecular, cellular, computational sciences to supplement or replace more traditional methods of toxicity testing and risk assessment. 

This Web page illustrates the approach EPA’s Pesticide Program is using to pursue new technologies that predict and characterize potential human health and environmental hazards and exposures from pesticides. This page describes the current status as well as future plans for this rapidly changing area of research and regulatory science.

On this page:

The new technologies will result in:

No single new technology can address all situations.  However, by using a suite of tools and approaches in combination, EPA’s Pesticide Program will be able to improve hazard and exposure assessments that form the basis for understanding potential pesticide risks.  With these improvements EPA can better achieve its goal of ensuring reliable protection of human health and the environment from adverse effects resulting from pesticide use.

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Pesticide Program Vision for Enhancing Integrated Approaches to Testing and Assessment

Over the next several years, EPA’s Office of Pesticide Programs (OPP) will improve and transform our approach to pesticide risk management by enhancing our ability to use integrated approaches to testing and assessment.

In this section:
Why a paradigm shift now?
  • This is a critical time. Science is rapidly advancing and new technologies are emerging.
  • Preparing now will enable OPP to take advantage of advances as soon as they are available, in an open and transparent manner.
What are the benefits of this paradigm shift?
  • Can evaluate more chemicals across a broader range of potential effects in a shorter time frame.
  • Potential to increase the feasibility of assessing the risks posed by mixtures.
  • Enhanced predictive ability to determine whether animal testing is needed to refine a risk assessment and to inform management decisions.
  • Refining and reducing animal testing by maximizing information obtained from animal studies, and focusing on effects of concern.
  • Opportunities for improved diagnostic biomonitoring and surveillance methods to detect chemical exposures and identify causes of toxic effects.
  • Enhancing the quality and efficiency of risk assessment and risk management decisions.

OPP is committed to protecting human health and the environment through application of the latest scientific tools to increase reliability and effectiveness in assessing and managing potential pesticide risks.

The Critical Path to an Integrated Approach

Our critical path focuses on fully utilizing an integrated approach to testing and assessment. The goal is to move toward a new paradigm where in vivo (animal) testing is targeted to the most likely hazards of concern.  This progressive, tiered-testing approach starts with hazard-based hypotheses about the plausible toxicological potential of a pesticide or group of pesticides based on their physical-chemical properties.  Existing exposure and toxicity information is then combined with computer modeling and ‘new’ diagnostic in vitro (non-animal) assays to target toxicity testing to the specific data needed for human health and ecological risk assessments.

The path forward will require an improved ability to predict chemical toxicity and exposure through application of efficient and effective screening tools including new in vitro assays that rapidly provide biological profiles of the toxicological potential of chemicals.  New technological advances to support more effective means of screening chemicals for potential effects will include new computer modeling approaches to predict chemical toxicity and exposure as well as  the development of new sensitive biomarkers that will enable tracking of pesticide exposures and their early effects in human and wildlife populations. Exposure and biomonitoring surveys of populations will be critical to interpreting toxicity data and for evaluating the effectiveness of the new testing and assessment paradigm.

Our strategic plan also includes the development of increasingly effective laboratory animal tests that are designed to maximize the information generated about the nature of the effects being studied.  These advances will be incorporated within a risk assessment framework of problem formulation, hazard, dose response, exposure assessment, and risk characterization to support pesticide registration decisions.

Achieving our objectives will require close collaboration with the scientific community, international organizations, and our government partners to build the foundation for understanding chemically-induced toxicity pathways.  This understanding will allow our program to enhance the direct relevance of our risk assessments to people and wildlife by moving toward a paradigm that is based on a chemical’s mode of action and a better understanding of real world exposures to pesticides. Consistent with the 2007 National Research Council (NRC) of the National Academy of Sciences report on Toxicology Testing in the 21st Century (PDF) (4 pp, 418k, About PDF) Exit EPA disclaimer, this scientific foundation will enable a shift to an integrated testing and assessment approach.

Pesticide Program Objectives

No single tool is intended to be used alone in a regulatory decision, but, rather, in combination with other methods. For chemicals that typically lack extensive existing test data, the new toxicity and exposure approaches will enhance priority-setting and screening approaches that will focus Agency and societal resources on those chemicals with the greatest risk potential. Directing subsequent test data generation on the most probable adverse effects with more effective and focused assays will reduce the time required for testing and also result in the use of fewer laboratory animals in toxicity testing.

Short-term Objectives to Result in More Efficient and Reliable Risk Assessments

Over the next five years, the Pesticide Program will enhance its integrated approach to testing and assessment to better determine what toxicity data are needed to further refine risk assessments for chemicals that do not have extensive toxicity information (e.g., inert ingredients, certain antimicrobial and biochemical pesticides, and metabolites and degradates of pesticide active ingredients).

OPP plans to maximize use of existing data from similar compounds, computer hazard and exposure modeling, and in vitro data to prioritize specific animal toxicity testing that is needed to assess and manage risks appropriately for these chemicals. Additionally, the current status of monitoring or biomarker methods for population surveillance, which can easily measure exposure, susceptibility and biological outcomes, will be assessed and the need for additional research will be identified.

Long-term Objectives to Realize a Risk Assessment Paradigm Shift

Over the next 10-15 years, as experience is gained and as our understanding of toxicity pathways increases, an enhanced integrated testing and assessment approach will be implemented for all pesticides including conventional agricultural pesticides. The approach will fully integrate hazard and exposure data along with advanced computer modeling based on new in vitro data and an understanding of toxicity pathways to better predict risks and to determine what additional data are necessary to provide a sound basis to characterize risks of concern. Data from improved biomarkers of exposure and biological outcomes from population-based studies will be used to evaluate the effectiveness of this new risk assessment paradigm, to readily identify early effects in exposed populations, and to improve the approach.

It will take time and substantial research to fully realize our vision and strategic direction. To that end, our program has partnered across EPA and with other federal agencies and international organizations to work collaboratively in an open and transparent manner. As we move forward, we will employ external scientific peer review and public participation as new integrated tools are developed and evaluated for inclusion in risk assessment methods. Enhancing the ability to use integrated approaches to testing and assessment holds the potential to usher in a new era of certainty, predictability and timeliness in the assessment of products that the Pesticide Program regulates.

Dr. Steven Bradbury, Director for Programs, Office of Pesticide Programs

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Understanding Integrated Approaches to Testing and Assessment

The challenge of evaluating the potential effects of thousands of chemicals in the environment cannot be met by the current testing and assessment approach alone. The current approach relies on data from many costly animal tests that can require years to complete.

Integrated approaches to testing and assessment will increase the information available to EPA for risk management decisions and accomplish this in less time with less animal testing. Implementing this approach requires scientists to make initial predictions of toxicity to create a tailored toxicity testing strategy for each chemical, including carefully targeted animal tests when needed for decision-making. This will be achieved by:

The key goals of integrated approaches to testing and assessment are to:

This approach will help us focus testing on pesticide chemicals and the effects that could most likely result in harm. As a result, testing would:

For the Pesticide Program, these new approaches over time will allow better use of government and societal resources for evaluation of pesticide active and inert ingredients to consider a broader range of potential toxic effects that may not have been considered previously, and to provide a better understanding of the mechanisms underlying potential areas of concern.

The ultimate outcome of this new approach will be enhancement of the quality of risk assessments and risk management decisions.

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Tools Matrix

EPA has developed a set of tables that describe plans to incorporate new scientific tools for integrated approaches to testing and assessment (PDF) (7 pp, 92k, About PDF) into the pesticide program. These tools reflect current as well as both near-term and long-term approaches.

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Partnerships

To advance integrated testing and assessment and enhance the capacity for priority-setting, screening, and evaluation of pesticide hazards, there are a wide variety of activities that involve various partners. These activities are part of an evolving process.

Partnerships Within EPA

OPP is working closely with partners across EPA to define the research and to evaluate new tools to improve the efficiency and reliability of testing and assessment. These partners include:

For example, the U.S. Environmental Protection Agency’s Strategic Plan for Evaluating the Toxicity of Chemicals will serve as a blue print for implementing the 2007 NAS recommendations on Toxicity Testing in the 21st Century.

Partnerships With Other Federal Agencies

International Projects

The ways in which computer-aided approaches are used to predict effects on human health and the environment depends on the requirements of the specific legislation and needs of the regulatory authority. There is global interest in facilitating and expanding the role of predictive computer approaches in regulatory settings (for example see Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology (PDF) (79 pp, 558k, About PDF)) Exit EPA disclaimer.

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