EPA plans to limit TSCA CBI protections.
This summer, EPA published a proposal to modify regulations governing significant new uses of chemical substances (SNUR) under the Toxic Substances Control Act (TSCA) that could significantly impact protections for Confidential Business Information (CBI). The proposed rule would modify the bona fide intent procedures in 40 CFR 721.11 to allow EPA to disclose the confidential significant new use designations to a manufacturer or processor who has established a bona fide intent to manufacture (including import) or process a chemical substance. Specifically, the proposed regulatory language redefines the scope of “confidential business information” to exclude new use designations. Industry groups voiced their concerns with the proposal in comments submitted to the Agency last month. Some comments urged EPA to withdraw the proposal and re-propose it in conformity with the disclosure authorized by the Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
Section 14 of the Lautenberg Act prohibits the disclosure of “information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code,” the Public Information Section of the Administrative Procedure Chapter of this Title. The provision explicitly provides that this protection extends to “processes used in the manufacturing or processing of a chemical substance or mixture.” Several commenters stressed that it appears that the proposed regulation goes beyond what the statute allows.
The American Chemistry Council (ACC) noted in its comments that EPA needs only to respond to the bona fide intent requestor with a “yes” or “no” to address whether the proposed use of the SNUR substance is a new use. Therefore, the ACC stressed, the proposed amendment to 40 CFR 721.11 would disclose more confidential information than is necessary to answer the requestor’s question. Other comments, from the American Fuel & Petrochemical Manufacturers, argue that the Agency’s plans to disclose this information would create an anticompetitive environment by giving an advantage to those who submit bona fide intent notices.
In their comments, these industry groups also recommended EPA expand the SNUR CBI provision to impose additional requirements on both the Agency and chemical manufacturers. The ACC asserted that EPA should be required to inform the original PMN submitter when it discloses any confidential information to a requestor similar to the existing provision regarding the Confidential Inventory (40 CFR 720.25(b)(6)). Another set of comments, from the American Petroleum Institute, suggested that the Agency use consent order and SNUR requirements to compel manufacturers to inform downstream customers of all potentially applicable compliance requirements related to a substance.
The proposed amendments to the SNUR CBI provisions could affect EPA’s treatment of CBI under TSCA more generally. The Lautenberg Act requires manufacturers and importers to reassert CBI claims during the Inventory Reset process. The proposal for that process may also attempt to limit CBI protections.
