Published: 13 March, 2020
The EPA is undergoing review for updating the Confidential Business Information (CBI) substantiation requirements relating to substance reverse engineering under the Toxic Substances Control Act (TSCA). A supplemental notice was published in November 2019, with the public comment period ending in December 2019. Fast-forward to February 19th 2020, and the EPA has released a pre-publication version of the final TSCA CBI rule.
As described in the proposed final rule, the EPA will review CBI claims for substances on the active portion of the TSCA Inventory. This follows the requirements to notify substances as “active” or “inactive” as part of the 2016 Frank Lautenberg Chemical Safety for the 21st Century Act amendments.
Updates are to be submitted online using the Chemical Data Exchange (CDX) portal. This rule becomes effective 60 days following the publication in the Federal Register, and submissions must be made within 180 days of that date.
The pre-publication of this rule can be found here: https://www.epa.gov/tsca-inventory/prepublication-version-procedures-review-cbi-claims-identity-chemicals-tsca-inventory
Companies producing a chemical listed as one of the EPA’s 20 “High-Priority” substances will be required to pay a portion of the $1.35M risk evaluation costs. In addition to manufacturing and importing, this includes companies that produce the substance as an impurity, and companies that import the substance as part of an article. This is because the 2018 TSCA Fees Rule does not list exemptions for these actions despite being exempt from CDR and import certifications. This can be quite problematic when the upstream supply chain does not make the article composition readily available.
The EPA has published a partial list of manufacturers and importers that they have identified from the CDR and toxic release inventory (TRI). The EPA is asking companies to notify the EPA if they too are required to comply with these regulations. Failure to self identify will open non-compliant companies up to the penalties outlined in TSCA Section 16. The final list is expected to be published sometime this summer.
The window to self-report has been extended an additional 30 days until April 26, 2020.
EPA contact information and a list of High-Priority Chemicals undergoing assessment can be found here: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-undergoing-prioritization-high
The EPA has recently released the updated list of 20 “Low-Priority” substances that do not require risk evaluation under Section 6(b) of the 2016 Frank Lautenberg Chemical Safety for the 21st Century Act. The purpose of this process is to ensure prioritization of chemicals posing a high risk to both human health and/or the environment. The EPA believes that sufficient information is available for these substances to not warrant additional evaluation under TSCA.
Click here to view the full list: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/low-priority-substances-under-tsca
Dr Mike Wolfe, North America: Associate Regulatory Consultant