Gradient

Toxic Substance Control Act (TSCA)

Overview
Example Projects
Experts

Overview

Much has changed since 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 its manufacture, consumer and industrial uses, and disposal. Under draft rules from the US Environmental Protection Agency (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. 

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Example Projects

Risk Assessment Support Risk Evaluation Under Amended TSCA

Full Description

Gradient provided risk assessment support for asbestos, carbon tetrachloride, tetrachloroethylene, and methylene chloride in response to a US EPA notice requesting data for the first set of chemicals to be evaluated for risk under the amended TSCA. This included organizing and presenting the information for submission to US EPA as public comments.

Comments on Draft Prioritization and Risk Characterization Rules for the Humane Society

Full Description

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

Full Description

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

Full Description

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. The analyses was used to support an argument against the scientific need for toxicity test requests under the SNUR.

Experts

Lisa A. Bailey Read Bio

Jessie M. Kneeland Read Bio

Ari S. Lewis Read Bio

Lorenz R. Rhomberg Read Bio

Jiaru Zhang Read Bio