Webinar: Navigating the PMN Process under New TSCA: An Interactive Workshop

Date: March 20, 2017 8:30am-4:00pm EDT
Registration at: http://news.lawbc.com/s/92e9e6676220852f6fa3aa7c28ef5a2e5455bd3a
Organizer: Bergeson & Campbell PC

Since enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new Toxic Substances Control Act (TSCA)), the U.S. Environmental Protection Agency (EPA) has struggled to implement the new requirements under TSCA Section 5 and submitters have been challenged in preparing and obtaining timely decisions on Premanufacture Notices (PMN) and exemption requests.

EPA’s interpretation of its new requirement to make one of three determinations for each PMN and Significant New Use Notice has been and will continue to be a work in progress. The three available determinations under Section 5(a)(3) are:

  • The new chemical or significant new use presents an unreasonable risk; or
  • There is “insufficient information” to permit a reasoned evaluation of health or environmental effects, the chemical may present an unreasonable risk, or the chemical will be produced in substantial quantities and there may be significant or substantial exposure to the substance; or 
  • The new chemical or significant new use is not likely to present an unreasonable risk. 

Until EPA makes one of the determinations and concludes any needed regulatory actions (e.g., Section 5(e) order), the path to commercialization remains blocked. EPA has admitted to struggling with making these determinations and taking required actions, with the result that several hundred new chemicals are stuck in a review process that, due to its newness and relative opacity, is causing considerable commercial uncertainty and no small amount of frustration. It is now evident that few of the new chemicals notified in the past almost one year have completed the process and new chemical innovation has stalled.

To help submitters anticipate, understand, and navigate around the new challenges in the PMN process, Bergeson & Campbell, P.C. is partnering with the Society of Chemical Manufacturers and Affiliates (SOCMA), the Adhesives and Sealants Council (ASC), the American Cleaning Institute (ACI), and others on a one-day PMN workshop led by former high-level EPA officials, plus other experienced regulatory experts from industry and private practice.

The workshop will offer practical guidance on the new PMN process, including case studies and discussion of pre- and post-notification strategies, while providing a forum for participants to bring their own issues, experiences, and “tea leaf reading” to bear in the discussions. The workshop, through its presentations, discussions, and exchanges, is intended to enable participants to gain a greater understanding of EPA’s relatively opaque review process, while equipping chemical manufacturers and processors to better navigate the new process by anticipating and avoiding problems or by taking steps to free cases stuck in the review process.

Registration required. Register for in-person or webcast attendance online.

Registration is complimentary but space is limited for both the in-person workshop and the webcast; priority will be given to members of sponsoring organizations.


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