In the Federal Register published on November 8, 2019 the Environmental Protection Agency (EPA) proposed revisions to existing and proposed substantiation requirements for certain Confidential Business Information (CBI) claims made under the Toxic Substances Control Act (TSCA). Manufacturers and processors would be required to answer two additional questions. EPA also proposed procedures for manufacturers and processors to answer the questions for certain previously-submitted substantiations. The proposed revisions supplement the proposed rule from April 23, 2019 and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule adopted on August 11, 2017. Public comments will be accepted through December 9, 2019.
EPA is proposing this rule to address a D.C. Circuit Court opinion in Environmental Defense Fund v. EPA, released on April 26, 2019, which ordered EPA to address its arbitrary elimination of substantiation questions regarding reverse engineering. The Court’s ruling was that EPA did not fulfill its statutory mandate to require that a person asserting a CBI claim include a statement that the person has a “reasonable basis to believe that the information is not readily discoverable through reverse engineering,” and “must substantiate the claim.”
The two questions EPA is proposing to add are:
1. 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?
2. 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?
For manufacturers and processors that have not yet submitted any substantiation, the required answers would be submitted at the same time as the rest of the substantiation. For those who have already voluntarily submitted a Notice of Activity (NOA) Form A, or will have submitted substantiation in an NOA Form B before the questions are finalized and effective, the submissions would be required to be supplemented with the two answers. For Form A supplements, EPA is proposing a deadline of no later than 90 days after the effective date of the rule. For Form B supplements, EPA is proposing a deadline of no later than 30 days after the effective date of the rule.