Irene Hantman to present at American Chemical Society 253rd National Meeting in San Francisco April 4

The symposium is titled, “Recent Developments in TSCA Regulation — New Requirements for Chemicals in Commerce.” Ms. Hantman will be presenting with:

  • Maria Doa, Director, Chemical Control Division, Office of Chemical Safety and Pollution Prevention, EPA
  • David Liu, Principal Ramboll Environ
  • Keith Matthews, Counsel, Wiley Rein LLP

The symposium will include an overview of TSCA and the Lautenberg Amendments, discuss regulatory updates from EPA including changes to how the Agency evaluates new chemicals, and discuss implications for chemicals in commerce such as changes to CBI protections and the Nanomaterials Reporting Rule. The program abstract is provided below.

The June 22, 2016 enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act effectuated a sea change in U.S. chemicals regulatory policy and imposed many new requirements on EPA and the manufacturers, importers, and processors of chemical substances. Some requirements took effect the moment President Obama signed the Act; other changes will be implemented over the next few years. Lautenberg mandates that the Agency issue a number of new rules by June 2017. To meet this schedule, EPA will be taking and responding to comments on its proposals during the spring of 2017. Proposed rules will affect the identification of chemicals currently in commerce through a TSCA “Inventory Reset,” and how EPA assesses the risks presented by these chemicals. The Inventory Reset process could have significant impacts on a company’s ability to continue routine manufacturing activities (for example, substances classified as inactive will not be allowed in commerce, or there may be questions about the actual identity of compounds now in commerce). Importantly, the final rules implementing the Prioritization and Risk Assessment processes will determine the processes and criteria that EPA will use to identify high priority chemicals for risk evaluation, how it will evaluate the risks presented by these chemicals and the amount of flexibility that EPA will allow in these processes. In addition, the Agency will revisit the Confidential Business Information (CBI) claims on chemicals presently in commerce, including claims that withhold the actual identity of chemicals. Submitters will be required to substantiate past claims to continue receiving CBI protections.

* * * * *

For a copy of the presentations contact Ms. Hantman at ihantman@verdantlaw.com.

Processors and Downstream Users Comment on the Inventory Reset Proposed Rule, Asking for Clarity

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). The proposal details notification requirements and establishes exemptions and procedures for handling confidentiality claims. 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. For inactive substances, EPA proposed “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.

Many comments to the proposed rule were received from interested parties, including coalitions and trade associations – examples are provided below.

A downstream user coalition has questioned the proposed requirement under the TSCA inventory reset proposed rule that a processor of an inactive substance submit notification to the EPA prior to its use. The Chemical User Coalition (CUC), a cross-industry group of nine major companies, including Intel, Boeing, Honda and Procter & Gamble, said in its comments that the inventory reset provisions should only be relevant to reporting, and a failure to adhere to the notification deadline should constitute a reporting violation, not affect a company’s ability to process substances on the inventory.

IPC, the Association Connecting Electronics Industries, in its comments requested clarification of the term “processors” stating that the definition currently in place is “overly simple and prone to misinterpretation.” Specifically, IPC requested that EPA clarify that processing does not include assembling parts into articles, when it does not involve the preparation of a chemical substance or mixture.

Others pointed out that because processors are not required to report pre-manufacture notices or under the Chemical Data Reporting rule, that many would be wholly unfamiliar with the EPA’s CDX reporting system.

The comment period on the inventory rest proposed rule ended March 14, 2017.