U.S. Toxic Substances Control Act (TSCA) Chemical Regulatory Services

Intertek has solutions for all your chemical regulatory needs under the Toxic Substances Control Act (TSCA), and the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) amendment to TSCA.

TSCA, administered by the United States Environmental Protection Agency (USEPA or EPA), regulates the introduction of new chemicals and existing chemicals. All chemicals manufactured or imported and intended for commerce within the U.S. are required to be listed on the Toxic Substances Control Act (TSCA) inventory. It is critically important to understand TSCA nomenclature when reviewing the Inventory.  If a company intends to manufacture or import a new chemical substance for a commercial purpose, a Premanufacture Notice (PMN) must be submitted to the Environmental Protection Agency (EPA).  PMNs for imported new chemical substances should be submitted by the principal importer as defined at 40 CFR §720.3(z).

Through the LCSA, the general approach to chemical safety has been strengthened by explicitly requiring that the EPA make an affirmative determination on all Premanufacture Notices (PMNs) and significant new use notices (SNUNs) that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

This new requirement for affirmation before a company can proceed to the marketplace is seemingly increasing the scrutiny of the assessments and challenging industry with additional data and extended timeframes. The LCSA is also impacting existing markets with a more defined approach to the risk assessment and risk management of chemicals already listed on the TSCA inventory.  Finally, companies with a critical interest in CBI will need to pay greater attention as the new Act changes the type of information that can be protected as confidential and defines substantiation requirements for these claims. 

To support companies in addressing these challenges, Intertek offers the following services: 

  • Regulatory Review: Analyzing product lines for compliance under TSCA
  • Preparation: Developing notification dossiers under TSCA Section 5
    • Premanufacture Notifications (PMNs)
    • Low Volume Exemption applications (LVEs)
    • Bona Fide notices for submission
    • Justification language for Polymer Exemption documentation
  • Science: Providing technical input into the dossier preparation and assessment process
    • Using EPA ecotoxicity models and methods to screen for potential risks
    • Analyzing chemistry and manufacturing processes in preparation for CAS IES requests to obtain or confirm formal substance identities
    • Designing cost and time efficient data-gathering strategies for new or existing chemicals (Structure-Activity Relationship (SAR) information, analogue data and test data)
    • Reviewing exposure information and providing feedback based on EPA risk assessment considerations
  • Confidential Business Information: Developing confidentiality substantiation and compliant generic names
  • Interpretation: Determining your obligations to respond to mandatory and voluntary chemical inquiries, including the Chemical Data Reporting Rule (CDR)
  • Documentation: Preparing mandatory and voluntary responses to EPA initiatives
  • Surveillance: Tracking draft and final risk assessment notices and proposed risk management measures
  • Smart Planning: Providing strategic advice regarding impact of proposed risk management measures
  • Consultation: Working with the regulatory authorities on matters relating to any proposed hazard-assessment outcomes and risk management measures for your chemicals
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