On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), which amends the Toxic Substances Control Act (TSCA; also known as Amended TSCA), was signed into law. USEPA is now required to make an affirmative determination of “not likely to present an unreasonable risk” on a new chemical or significant new use of an existing chemical before manufacturing and commercial distribution can commence.  In addition, on an ongoing basis, twenty or more existing chemicals will be identified as “high priority.”  The designation of a chemical as high-priority under the Act triggers a detailed risk evaluation by USEPA to determine its safety and whether any restrictions are needed to ensure its safety during “reasonably foreseen” uses over its lifecycle.

During the first half of 2017, EPA has identified the first ten high-priority chemicals for risk evaluation, and issued proposed guidance for prioritization and safety determination of new chemicals and risk evaluation of existing high-priority chemicals.  The Amended TSCA rules, guidance, and processes are underway, and will have a significant impact on the chemical industry, as well as manufacturers that use chemicals in their products.

ToxStrategies consulting scientists have extensive experience in providing excellent scientific services to support chemical safety assessment and product stewardship. These consulting services are valuable for supporting timely, effective, and defensible decision making and submittals for both new-chemical safety determinations and existing-chemical risk evaluations under the LCSA.  Examples of our key services in this area include:

  • Pre-prioritization of chemicals to predict their potential to be subject to risk evaluation and restrictions by USEPA
  • Technical support for challenges to USEPA new-chemical safety determinations and existing-chemical/significant new-use prioritizations, risk evaluations, and chemical restriction decisions
  • Preparation of risk evaluation scoping documents, including conceptual model, analysis plan, and data needs
    • Systematic review of toxicology literature
    • Incorporation of weight-of-evidence analysis
  • Development and basis documentation of conditions of use, including focus on (a) uses for which manufacturing, processing, or distribution in commerce is intended, known to be occurring, or reasonably foreseen to occur; and (b) exposures that are likely to present the greatest concern
  • Hazard assessment for new and existing chemicals
    • Identification of data gaps, consideration of alternative testing methods to fill data gaps
  • Identification, planning, and monitoring studies to fill data needs (e.g., in vivoin vitro, and in silico), along with data interpretation
  • Toxicology data management
  • Incorporation of weight-of-evidence analyses
    • Application of computational toxicology approaches such as:
      • Quantitative structure activity relationship (QSAR)
      • Chemical read-across and categorization
      • Physiologically based pharmacokinetic modeling for estimating inter-individual variability
      • Evaluation of in vitro high-throughput screening assay data
    • Predictive methods to assess exposure assessment and chemical fate
    • Identification of highly exposed and susceptible subpopulations
    • Preparation of Draft Risk Evaluations for submittal to USEPA in accordance with “Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act”
    • Preparation of risk evaluations for metals under the EPA “Framework for Metals Risk Assessment”

For further information about ToxStrategies’ consulting services, please contact us here.