EPA is proposing two additional questions addressing reverse engineering that companies would be required to answer to substantiate CBI claims for specific chemical identities; and is proposing procedures for companies to use in amending certain previously-submitted substantiations to include responses to the additional questions.
Amended TSCA requires EPA conduct risk evaluations of at least 20 chemicals at any given time, from chemicals it has designated as “high priority.” EPA will use the prioritization process to consider data availability, uses of candidates and risk evaluation methods to inform scoping early in the risk evaluation process.
EPA aims to amend its Chemical Data Reporting rule to update the definition of small entities (small manufacturers), who are exempt from reporting, and add exemptions for specific types of byproducts, to simplify reporting.
EPA is required to prioritize 20 chemical substances as candidates for designation as High Priority Substances for risk evaluation, and 20 chemical substances as candidates for designation as Low Priority Substances for risk evaluation.
Under the amended TSCA, EPA must conduct risk evaluations on its initial 10 chemicals, and could impose restrictions on the use of these compounds or bans, in risk mitigation rules EPA will develop after finalizing risk evaluations.
The bill would require a product manufacturer or chemical manufacturer to provide to DTSC data and information on the ingredients and use of a consumer product, including, but not limited to, specified data and information, including data on ingredient chemical identity, concentration, and functional use.
A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory – 47 percent or 40,655 of the 86,228 chemicals – are currently active in commerce.
EPA is accepting comments objecting to one or more of these Significant New Use Rules through Dec. 31, 2018.
EPA took this action following receipt of adverse comments and a request to extend the comment period regarding the Significant New Use Rules.
Under the 2016 TSCA amendments, EPA is required to focus on 40 chemicals next year and designate 20 as “high priority.” EPA must designate at least 20 chemical substances as High-Priority for risk evaluation and 20 chemical substances as Low-Priority by December 2019. That designation means the agency must launch a detailed risk evaluation.