TSCA: Potential for Reform & Current Programs
Exponent’s chemists, toxicologists, ecotoxicologists, and environmental and exposure assessment professionals have a wide-range of experience in managing complex projects, and have the technical and regulatory expertise to assist clients with TSCA existing chemical requirements. Our staff includes consultants who have previously held managerial positions in the EPA Office of Chemical Safety and Pollution Prevention (OCSPP), and we additionally have significant and successful technical and administrative task force management experience. We are prepared to work with you and your company to design a program to support your TSCA needs.
The primary US law overseeing the safety of chemical products – the Toxic Substances Control Act (TSCA) – was passed in 1976. It provides EPA with the authority to review and regulate both new chemicals and existing chemicals, the latter category including chemicals that are on the TSCA Inventory (over 84,000 chemicals).
While almost everyone, including government, industry, the public, agrees that TSCA needs to be modernized, there is disagreement on the details. Principles for TSCA reform have been published by the US EPA and industry. Senate Bill 847 (“Safe Chemical Act”), which has the support of environmental and public-health groups, would revise the law's current unreasonable risk safety standard with a reasonable certainty of no harm standard. The reasonable certainty of no harm standard is section 408 of the US Food Drug and Cosmetic Act (FDCA).
Even without the new legislation, EPA is taking steps to enhance the “Agency’s existing chemicals management program” within the limits of existing authorities. In March 2012, EPA identified a work plan of 83 chemicals for further assessment under the TSCA. EPA identified seven of these chemicals for risk assessment in 2012, and requested available information from stakeholders. On June 1, 2012, EPA identified 18 more of these chemicals for assessment in 2013 and 2014. EPA intends to use the TSCA Work Plan Chemicals to help focus and direct the activities of the Existing Chemicals Program over the next several years.
The first five of these risk assessments were released by EPA on January 4, 2013. Following peer review, EPA will determine what risk management actions may be required for these chemicals.
Exponent’s services include:
- Task force/consortium management
- Hazard, exposure, and risk assessments
- Assessment of available data
- Data gap analysis
- Preparation of data summaries for submission to EPA
- Chemical grouping, read-across, and SAR analysis and assessments (including DEREK, OECD QSAR Toolbox 2.2 modeling, and ChemPrint metabolism modeling)
- EPA Sustainable Futures Modeling and Interpretation (e.g., EPI Suite™, E-Fast, AIM,Down the Drain, ECOSAR, ChemSTEER)
- Project management.
EPA’s programs are more fully described at: