International approaches toward chemical management— such as the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) policy— have provoked intense interest in the reform of U.S. chemical management legislation, specifically the Toxic Substances Control Act (TSCA). TSCA reform was the subject of the American Bar Association’s (ABA) National Spring Conference on the Environment, held June 11 in Baltimore, Maryland. The central component of recently proposed TSCA reform legislation in the U.S. is a fundamental paradigm shift in the burden of proof, such that chemical manufacturers and processors would be required to demonstrate safety as opposed to the regulatory agency having to demonstrate harm. Such broad-based reform will increase the regulatory burden for many companies, many of which are already under increased burden due to REACH and the recently implemented endocrine disruptor screening program (EDSP).
Integral’s toxicology and risk assessment experts are closely following developments in TSCA reform to best serve our clients who may be required to comply with new chemical management legislation. Our specific services in the area of regulatory compliance include:
• Hazard identification and toxicity evaluation
• Exposure assessment, including fate and transport modeling and pathway
analysis
• Critical, objective data review and analysis, including evaluation of other
scientifically relevant information (OSRI)
• Premanufacture Notice (PMN) preparation
• Test strategy development and oversight
• Regulatory negotiation
• Expert testimony and litigation support.
For more information about TSCA reform and EDSP compliance, please contact Dr. Jennifer Fleischer at jfleischer@integral-corp.com.