Overview of Risk Assessment in the Pesticide Program
The process EPA uses for evaluating the potential for health and ecological effects of a pesticide is called risk assessment. This page provides a brief introduction to the Pesticide Program’s risk assessment program and includes links to other pages where further information is available.
Risk assessment is crucial to the process of making decisions about pesticides, both new and existing. New pesticides must be evaluated before they can enter the market. Existing pesticides must be re-evaluated periodically to ensure that they continue to meet the appropriate safety standard. The decision process is part of a risk management process, which is conducted in registration for new pesticide chemicals or new uses of existing chemicals, or reregistration or registration review in the case of a general review of an existing chemical.
On this page:
- Ecological Risk Assessment
- Human Health Risk Assessment
- Assessing Pesticide Cumulative Risk
- Models, Databases, and Guidelines
Ecological risk assessment includes three phases, and is generally conducted following the Guidelines for Ecological Risk Assessment (U.S. EPA, 1998).
- Planning - Planning and Scoping process
EPA begins the process of an ecological risk assessment with planning and research.
- Phase 1 - Problem formulation
Information is gathered to help determine what plants and animals are at risk and need to be protected.
- Phase 2 - Analysis
This is the determination of what plants and animals are exposed and to what degree they are exposed, and whether or not that level of exposure is likely to cause harmful ecological effects.
- Phase 3 - Risk characterization
Risk characterization includes two major components: risk estimation and risk description. "Risk estimation" combines exposure profiles (i.e., the findings of exposure characterization) and effects from exposure. "Risk description" provides information important for interpreting the risk results and identifies a level for harmful effects on the plants and animals of concern.
For more information on ecological risk assessment in the Pesticide Program see:
- A brief overview of ecological risk assessment
- Technical overview of ecological risk assessment
- Process for assessing pesticide risks to endangered species
- What types of health problems are caused by pesticides in the environment?
- What is the chance that people will experience problems when exposed to different levels of pesticides?
- Is there a low level below which some chemicals don’t pose a human health risk?
- What pesticides are people exposed to and for how long?
- Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnic practices, gender, where they work, where they play, what they eat, etc.
EPA uses the National Research Council’s four-step process for its Human Health Risk Assessments:
- Step 1 - Hazard Identification
Examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
- Step 2 - Dose Response Assessment
Examines the numerical relationship between exposure and effects.
- Step 3 - Exposure Assessment
Examines what is known about the frequency, timing, and levels of contact with a substance.
- Step 4 - Risk Characterization
Examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.
For more information on human health risk assessment in the Pesticide Program, see:
- A brief overview of assessing health risks from pesticides
- EPA’s Risk Assessment Process for Tolerance Reassessment (PDF) (15 pp, 247k, About PDF)
- Available information on assessing exposure from pesticides in food—A User’s Guide (PDF) (52 pp, 511k, About PDF)
EPA has guidance for performing cumulative risk assessment (PDF) (90 pp, 490k, About PDF) as well as for identifying pesticides chemicals and other substances that have a common mechanism of toxicity (PDF) (14 pp, 76k, About PDF).
EPA has determined that pesticides have four common mechanism groups of toxicity and has performed cumulative risk assessments for these groups. Future assessment will be conducted for any other common mechanism groups identified in the future.
The risk assessment process depends on having appropriate data and using well tested models. Data required for pesticide registration are found in 40 CFR Part 158. EPA also has guidelines for how testing is to be conducted, which are harmonized into a single set of guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.).
EPA’s test guidelines also are harmonized with those established by the Organisation for Economic Co-operation and Development (OECD). Harmonized test guidelines reduce the burden on chemical producers and conserve scientific resources, including the minimal use of laboratory test animals. They also form a basis for work sharing and cooperation among all OECD countries. EPA accepts data developed based on an OECD test guideline.
For more information on Models, Databases, and Guidelines in the Pesticide Program, see:
- Information about EPA’s data requirements for pesticide registration
- Listing of models and databases commonly used by EPA’s Pesticide Program
- Harmonized test guidelines
- Harmonized OECD test guidelines