EPA grants chemical makers another chance to protect trade secrets
Chemical manufacturers have a renewed opportunity to protect the confidentiality of the chemicals they make or import, according to an announcement by the US Environmental Protection Agency (EPA).
The EPA confirmed yesterday, January 5, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification (active-inactive) rule, which required anyone who manufactured or imported a chemical substance during a ten-year time period ending June 21, 2016, to confirm whether the substance is still “active” in US commerce.
If the chemical is deemed inactive, then it becomes listed in the “public portion” of the TCSA, which can then be viewed by the general public.
This move effectively revives a 2017 regulation that enabled chemical manufacturers to keep the specific identity of certain compounds secret from the public and competitors. The reporting period up until August 2018 allowed submitters to assert claims to retain specific chemical identities as confidential business information (CBI).
In April 2019, the US Court of Appeals for the District of Columbia Circuit ordered a limited remand without vacatur of the TSCA Inventory Notification (Active-Inactive) Requirements rule. This required the EPA to address how companies should substantiate claims that a chemical substance’s specific chemical identity should be protected from disclosure as a trade secret.
In May 2020, the EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory. In yesterday’s announcement, however, the EPA stated that it has become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period.
“These issues may have inadvertently undermined existing, potentially valid, CBI claims for chemical identity,” the EPA said.
It added: “The agency has been informed that affected businesses would lose the confidential treatment of chemical identities unless the agency reopens the reporting period for the Active-Inactive Rule. Certain entities have indicated to EPA that they either misunderstood the reporting requirements and did not submit the filings pursuant to the requirements of the... rule or made mistakes in their filings.”
The EPA noted that, according to the TSCA, a specific chemical name identifies every known structural feature intended to be part of a chemical substance’s specific chemical identity, and it may also reveal process information, eg, information on the manufacturing or processing of the chemical substance.
It further added that when the chemical identity is on the confidential portion of the TSCA Inventory, it represents “significant and valuable IP”, an important innovation by the entity or its partner. “Publicly revealing this information could result in the loss of this IP, which could substantially injure a company’s competitive position,” the EPA added.
Consequently, the EPA is allowing companies to submit, amend, or withdraw filings under the updated rule to maintain existing CBI claims for specific chemical identity.
Environmental groups are expected to denounce this latest development, as they have long argued that the public needs to be informed about the existence and potential risks of chemicals, Bloomberg has reported.
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