Environmental Risk Assessment
Environmental Risk Assessment
- Preparation of Environmental Risk Assessment reports and supporting scientific summaries for chemicals, ingredients, raw materials, pharmaceutical products, and other regulated substances
- Assessment of relevant environmental hazard and ecotoxicological endpoints
- Identification of data gaps and evaluation of scientifically appropriate approaches to address them
- Assessment of potential environmental exposure associated with relevant use, release, and lifecycle scenarios
- Assessment of potential adverse effects of relevant substances on aquatic, terrestrial, and other relevant environmental organisms
- Evaluation of available information on degradation, persistence, bioaccumulation, mobility, transformation, and environmental distribution of substances
- Evaluation of PBT/vPvB and other relevant environmental hazard characteristics
- Evaluation, derivation, and interpretation of Predicted Environmental Concentrations (PECs) and Predicted No-Effect Concentrations (PNECs)
Frequently Asked Questions
An Environmental Risk Assessment (ERA) is a scientific process used to evaluate whether the release of a substance into the environment may result in unacceptable risks to aquatic, terrestrial, or other relevant environmental organisms under its intended conditions of manufacture, use, disposal, and environmental exposure.
Environmental Risk Assessment generally involves Hazard Identification, Hazard Characterization, Exposure Assessment, and Risk Characterization.
Depending on the substance and regulatory context, information may include environmental fate data, ecotoxicological information, use patterns, release scenarios, environmental exposure estimates, and other relevant scientific data needed to characterize potential environmental risks.
Environmental Risk Assessments provide a scientific evaluation of potential environmental risks and can support regulatory submissions, compliance activities, product stewardship programs, risk management decisions, and other environmental assessment requirements.
Environmental Risk Assessments can be conducted for chemicals, biologicals, pharmaceutical products, degradation products, and other substances where evaluation of potential environmental risks is required.