According to the EPA, there are currently over 85,000 chemicals on EPA’s Toxic Substances Control Act (TSCA) Chemical Substance Inventory (Inventory), many of which are no longer actively produced. On January 13, 2017, the EPA published a proposed rule to reset the TSCA Inventory into separate lists of “active” and “inactive” substances (i.e., inventory reset). EPA is proposing to require use of the Agency’s electronic reporting portal, Central Data Exchange (CDX), for notification under this rule. The proposal details notification requirements and establishes exemptions and procedures for handling confidentiality claims.

The notification, to be entered into CDX no later than 180 days after the final rule is published, is retrospective in nature and is required for substances listed on the Inventory and that were manufactured or imported into the U.S. for non-exempt commercial purposes in the last ten years (between June 21, 2006 and June 21, 2016). Notifications for substances that were “processed” during this period would not be required, however, the proposal allows processors to report no later than 360 days after the final rule is published.

Properly notified substances would be designated by EPA as “active,” whereas substances without a valid notification would be designated as “inactive.”

Once designated, “inactive” substances could not properly be manufactured, imported, or processed for a non-exempt commercial purpose under TSCA. Thus, EPA also is proposing “forward-looking” procedures for notifying inactive substances if and when non-exempt manufacture, import, or processing would resume in the future. Properly notified substances would be converted by EPA to “active” substances.

TSCA Section 8 requires EPA to compile an “interim list” of active substances before promulgation of the final rule. The proposed rule would not require manufacturers to report chemical substances that are on the “interim list.” Indeed, in the proposal, manufacturers and processors of chemical substances on the non-confidential portion of the Inventory would be exempt from reporting if the manufacture of that chemical substance was already reported (by any party) in response to 2012 or 2016 Chemical Data Reporting (CDR).

Comments on the proposal must be received by March 14, 2017.

The EPA is proposing to place limits on the use of two common chemicals in paint removers in order to protect consumers and workers from serious health risks associated with this use. The chemicals are methylene chloride and N-methylpyrrolidone (NMP).

In a 2014 assessment, EPA concluded that methylene chloride can cause a range of adverse health effects, including harm to the central nervous system, liver toxicity, and cancer. EPA is now proposing to prohibit manufacture (including import), processing, and distribution in commerce of methylene chloride when used as a paint remover, except for commercial furniture refinishing which the Agency will address in a separate proposal. EPA is also proposing to require manufacturers, processors, and distributors to notify retailers and others in their supply chains of the prohibitions.

EPA assessed NMP in 2015 and identified risks to people, particularly pregnant women and women of childbearing age, who have high exposure to NMP through paint or coating removal. EPA is inviting comments on two approaches to address the risks from NMP. One approach would prohibit manufacture (including import), processing, and distribution in commerce of NMP when used as a paint remover, as well as require various notification measures on the restrictions to downstream processors and users. The other approach would put in place a combination of requirements to address unreasonable risks, including limiting the amount of NMP in paint remover products, providing warning labels for consumers, and requiring workers to wear specialized gloves and other equipment. EPA is seeking comment on both approaches. In addition, EPA is proposing to exempt certain national security uses of methylene chloride and NMP from the requirements of this rule.

Comments on the proposed rule must be received 90 days after date of publication in the Federal Register.

Read the pre-published proposed rule here.

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 21^st 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.