• If EPA designates a chemical as a High-Priority Substance, the chemical moves immediately to the risk evaluation phase.

The second step in the Environmental Protection Agency’s (EPA’s) process for evaluating the safety of existing chemicals is risk evaluation. If EPA designates a chemical as a High-Priority Substance, the chemical moves immediately to the risk evaluation phase. At the conclusion of the risk evaluation phase, EPA must use the risk evaluation as a basis to determine whether or not the chemical presents an unreasonable risk to health or the environment under the chemical’s conditions of use.

The Toxic Substances Control Act (TSCA) prohibits EPA from considering non-risk factors (e.g., costs/benefits) during risk evaluation. This includes risks to subpopulations who may be at greater risks than the general population, such as children and workers.

The risk evaluation process has the following components:

• A scope document that provides the public with information on the focus of the risk evaluation;
• Hazard and exposure assessments and a risk characterization to inform the risk determination; and
• A risk determination stating whether or not a chemical substance presents an unreasonable risk to health or the environment under its conditions of use.

In addition to EPA’s prioritization process, TSCA allows manufacturers to request that EPA conduct a risk evaluation on a particular chemical. When this happens, manufacturers are required to provide EPA with the information necessary to conduct a risk evaluation on those conditions of use that are of interest to them. Like the prioritization process, the risk evaluation process affords opportunities for public comment and submission of relevant information.