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 new chemicals or significant new use of an existing chemicals before manufacturing and commercial distribution can commence.  In addition, on an on-going 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, 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 under way, and will have a significant impact on the chemical industry, as well as manufacturers that use chemicals in their products.

ToxStrategies has extensive experience in providing excellent science services to support chemical safety assessment and product stewardship. These 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 some 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 vitroand 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 our services, please contact us here.

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