Much has changed since the Toxic Substance Control Act (TSCA) went into effect over 40 years ago, and the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to TSCA provide more certainty for consumers, states, and the chemical industry on how chemicals will be prioritized and evaluated for potential risk associated with their manufacture, consumer and industrial use, and disposal. Under draft rules from the US EPA, new chemicals will receive a more extensive review and additional data are required to support the Agency’s affirmative safety evaluation. Another important change is that all chemicals active in commerce will be categorized by US EPA as either high priority or low priority for further risk evaluation.
Gradient is actively participating in all aspects of the new TSCA implementation. Our regulatory knowledge and technical expertise positions us well to help stakeholders with new or existing chemical evaluations and to understand the implications of upcoming regulatory milestones.
Gradient teams with the Humane Society of the United States (HSUS). Read about our partnership.
TSCA Risk Assessment Support
For a consumer product manufacturer, Gradient compiled information needed to fulfill reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). We reviewed the client’s products to determine which of their products were reportable under this rule, and we prepared a user-friendly questionnaire for suppliers to gather additional product information for our client. We also built a database to organize and store product information.
TSCA Risk Assessment Support
Gradient provided risk assessment support for asbestos, carbon tetrachloride, tetrachloroethylene, trichloroethylene, and methylene chloride in response to US EPA’s risk evaluations for these chemicals under the amended TSCA. This included organizing and presenting information for submission to US EPA as public comments related to manufacturing processes, occupational exposure data, personal protective equipment, and potential for ambient exposures beyond the fenceline.
Comments on Draft Prioritization and Risk Characterization Rules for the Humane Society
In coordination with the Humane Society of the United States (HSUS), Gradient provided written comments to US EPA regarding the draft chemical prioritization and risk evaluation rules. Our comments focused on providing more transparency during the “Pre-Prioritization” process and providing a framework that articulates alternatives to animal testing and the types of non-animal tests that US EPA will recommend.
TSCA Chemical Registration
Gradient evaluated a large number of products for exemptions, premanufacture notice (PMN) requirements, and data reporting obligations. Our expertise in read-across, complex chemistries, and careful documentation helped our client avoid unnecessary PMNs and implement sustainable compliance strategies.
Rationale for Significant New Use Notification Test Waiver
Gradient evaluated the scientific credibility of a Significant New Use Rule (SNUR). We reviewed toxicity data for the chemical of interest, selected chemical surrogates to further inform the toxicity assessment, and utilized modeling-based approaches to characterize chemical bioavailability. Our analyses were used to support an argument against the scientific need for toxicity test requests under the SNUR.
TSCA New Owner Audit Support
Gradient conducted a TSCA New Owner Audit on a portfolio of products manufactured by an acquired company, which involved determining whether each component was on the active TSCA inventory, documenting appropriate exemptions from inclusion on the TSCA inventory, evaluating the applicability of any SNURs or Test Rules, and assessing whether any of the chemical substances were subject to export notification requirements.
