The new chemicals process at the Environmental Protection Agency (EPA): structure-activity relationships for hazard identification and risk assessment

• Published in: Toxicology Letters Vol. 79; no. 1; pp. 67 - 73
• Main Authors: Wagner, P.M., Nabholz, J.V., Kent, R.J.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01-09-1995; Amsterdam Elsevier Science
• Subjects: Animals; Biological and medical sciences; General aspects. Methods; Hazard assessment; Hazardous Substances - toxicity; Humans; Legislation as Topic; Medical sciences; Risk Assessment; Structure-Activity Relationship; Structure-activity relationships (SAR); Toxicity Tests - standards; Toxicology; United States; United States Environmental Protection Agency - standards; United States; North America; America; Hazard assessment; Risk assessment; Structure-activity relationships (SAR); Human; Evaluation; Structure activity relation; Toxicity; Chemical compound; Risk; Regulatory institution; Public health; Environmental protection
• ISSN: 0378-4274; 1879-3169
• DOI: 10.1016/0378-4274(95)03358-R

Section 5 of the Toxic Substances Control Act (TSCA) does not require any toxicity testing as a prerequisite for submission of a Premanufacturing Notice (PMN) for a new chemical. In order to compensate for the lack of actual test data, a process involving structure-activity relationships (SAR) for assessing hazard potential was constructed. The hazard assessment is then coupled with an estimation of potential exposure to determine potential risk. This process involves the use of multiple interdisciplinary teams that work within a 90-day time frame to complete approximately 2000 risk assessments per year.