The EPA is proposing to add two questions to the list of questions chemical manufacturers (which include importers) and processors must answer to substantiate claims that the identities of chemicals must be protected from public disclosure. Both questions relate to reverse engineering, defined as a process “to disassemble and examine or analyze in detail (a product or device) to discover the concepts involved in manufacture usually in order to produce something similar.”
The Agency’s proposal follows a partial remand from the D.C. Circuit of a 2017 final rule that required persons who manufactured a chemical substance for nonexempt commercial purpose during the 10-year time period ending on June 21, 2016, to notify the Agency that those chemicals are either active or inactive. As required by the 2016 amendments to the Toxic Substances Control Act (TSCA), the intent of the notification requirement is to update the TSCA Chemical Substance Inventory. The rule included procedures for forward-looking notification of chemicals on the TSCA Inventory designated as inactive if and when the manufacturing or processing of those chemicals for nonexempt commercial purposes is expected to resume.
The 2017 rule also included a list of questions the submitter needed to answer to substantiate a confidential business information (CBI) claim applicable to the identity of chemicals. In Environmental Defense Fund v. EPA, the D.C. Circuit agreed with petitioners that the final rule did not include necessary questions about reverse engineering. Specifically, under the rule, the submitter did not need to explain that the identity of the chemical was not discoverable through reverse engineering. In other words, according to the court, a chemical company should not be allowed protection for a chemical that can be identified by anyone competent in independently identifying the components of that chemical through reverse engineering. The court noted that “it makes no sense” to treat as confidential the chemical identity of a substance that can readily be discovered through reverse engineering.
“[T]he EPA’s Rule offers no sensible explanation at all for that gap in substantiation, nor does it even acknowledge the consequence of its omission,” the court stated. “That error is fatal. The Inventory Rule is arbitrary and capricious to the extent that it omits any substantiation requirement pertaining to reverse engineering.”
Accordingly, the current proposal would alter the CBI requirements for anyone who reported a confidential chemical substance under the TSCA Inventory Notification Active-Inactive rule through a Notice of Activity (NOA) Form A or an NOA Form B and sought to maintain an existing CBI claim for a specific chemical identity.
(Form A is a onetime notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the 10-year time period ending June 21, 2016. Submission of Form B is ongoing and is submitted by those who intend to manufacture or process for nonexempt purposes a chemical substance designated as inactive on the TSCA Inventory.)
The proposal would amend the 2017 rule as well as the Agency’s April 2019 proposal to establish a plan to review all CBI claims for specific chemical identity asserted in Form A.
Both Form A and Form B reporters would be required to answer the following two new questions:
- “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?”
Also, under the 2019 proposal, persons who had already submitted answers to substantiation questions pursuant to the voluntary process established in the Active-Inactive Rule would have been exempt from any further substantiation requirements. The Agency is proposing to revise that exemption to clarify that a previously submitted substantiation must contain information that is responsive to all substantiation questions in any rule that finalizes the proposal; this provision would relieve the submitter of the requirement to submit a new substantiation.