Earlier this month, the U.S. Environmental Protection Agency (EPA) proposed revisions to the confidential business information (CBI) substantiation requirements for the identity of chemicals on the Toxic Substances Control Act TSCA Inventory. Specifically, 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.
These proposed revisions supplement the proposed rule issued in the Federal Register of April 23, 2019, and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated in the Federal Register of Aug. 11, 2017.
EPA’s proposal stems from a recent D.C. Circuit Court’s ruling in litigation involving the Inventory Reset Rule. Companies that filed a claim to maintain a confidential identity when filing Form A, during the initial TSCA Inventory Rule reporting period, or when filing Form B, after the final inventory took effect, must respond to substantiate claims.
EPA is proposing to add the following questions to 40 CFR 710.37(c)(2):
- Does this particular chemical substance leave the site of manufacture or processing in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?
- If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product?
All persons who submitted substantiation information at the time of filing Form A would be required to submit responses within 90 days after the rule takes effect. This information would also be required for Form B submissions and later substantiations of Form A submissions.
EPA is accepting comments on the proposal through Dec. 9, 2019.
EPA’s TSCA Inventory Reset Rule establishes the process by which substances on the TSCA Inventory are designated as “active” or “inactive” in commerce. Once the TSCA Inventory has been “reset,” no one is permitted to manufacture or process an inactive chemical substance without first submitting a notification to EPA. As of Aug. 5, 2019, companies must notify EPA prior to initiating commercial activity with a chemical designated as “inactive” on the TSCA Inventory. ACA’s guidance addresses company obligations, including challenges presented where a manufacturer has listed a chemical on the TSCA Inventory as confidential.
The Inventory Reset Rule allowed companies to substantiate confidential identities at the time of filing Form A or at a later time as specified by EPA. For companies choosing to substantiate at a later time, in April 2019 EPA proposed using the same CBI substantiation questions used in the Inventory Reset Rule to substantiate at the time of filing Form A.
EPA’s Nov. 8, 2019 proposal would affect both companies that substantiated at the time of filing and those that would substantiate later, under the April 2019 proposal, as amended by this proposal.
EPA’s proposal is in response to the D.C. Circuit Court’s Opinion issued on April 26, 2019 (EDF v. EPA, Case No. 17-1201), adjudicating a petition filed by NGO’s contesting the Inventory Reset Rule (“Active-Inactive Rule” in EPA’s federal register notice). The Court held that EPA must include specific questions addressing whether chemical identity can be discovered through reverse engineering. Prior to this ruling, EPA required certification that identity is not discoverable through reverse engineering.
In this rulemaking, EPA is proposing two additional questions related to reverse engineering to substantiate claims of confidential identity. EPA is also proposing procedures for manufacturers and processors to use in amending previously-submitted substantiations to include responses to the additional questions.
Contact ACA’s Riaz Zaman for more information.
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