US EPA's Toxic Substances Control Act (TSCA) regulations require EPA to address pollution prevention, risk assessment, hazard and exposure assessment, characterization, and risk management for chemical substances and mixtures for new chemicals entering the marketplace, as well as those already listed on the TSCA Inventory. Under the auspices of the Regulatory High Production Volume (HPV) Challenge Program, companies voluntarily agreed to provide basic hazard information on more than 2,200 HPV “sponsored” chemicals. However, many “orphan” chemicals remained unsponsored. EPA has been obtaining basic hazard data for these unsponsored chemicals by invoking TSCA Section 4 test rules and TSCA Section 8(a) (production and use) and 8(d) (unpublished health and safety studies) rules. Most recently, EPA has also utilized the TSCA significant new use rules (SNUR) statutes, to manage risks for HPV unsponsored chemicals.
On October 21, 2011 -- EPA issued several actions under TSCA to address 60 high production volume (HPV) unsponsored "orphan" chemicals:
- Final Test Rule for the Third Group of HPV Unsponsored Chemicals (HPV 3) that requires manufacturers to test the health and environmental effects of 15 HPV chemicals
- Proposed Test Rule for the Fourth Group of HPV Unsponsored Chemicals (HPV 4) that would require manufacturers to test the health and environmental effects of 23 HPV chemicals
- Proposed SNUR for the Fourth Group of HPV Unsponsored Chemicals (HPV 4) that would require companies to notify EPA prior to new uses of an additional 22 chemicals that are widely used in commerce.
Exponent’s chemists, toxicologists, 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 HPV requirements.
We are uniquely prepared to assist throughout the HPV process in planning, data development, data compensation analysis, and discussions with EPA before and after your package is submitted to the Agency. Our staff includes consultants who have previously held managerial positions at 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 HPV needs.
Exponent’s services include:
- Task force / consortia management
- Study design, placement, and monitoring of testing programs
- Data compensation analyses
- Submissions related to Significant New Use Notices (SNUN) (as part of our full service TSCA New Chemicals management)
- Data assessment of publically-available data
- Data gap analysis
- 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.