All Knowledge & Insights By Date

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include: Agenda; and   Presentation. The new CBI web...

The U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) on November 25, 2019, for 22 chemical substances, including carbon nanomaterial (generic) (PMN P-10-366), that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 64754.  Persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by the SNURs to notify EPA...

By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...

By Lynn L. Bergeson On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these...

On October 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson On August 29, 2019, an article titled Population susceptibility: A vital consideration in chemical risk evaluation under the Lautenberg Toxic Substances Control Act was published in the PLOS Biology Journal. The article, written by academics, criticizes EPA for not identifying pregnant women, infants, children, families near industrial sites, and other susceptible and highly exposed populations in its risk evaluations. This lack of consideration for vulnerable populations,...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number. ...

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 25, 2019, Bergeson & Campbell, P.C. (B&C®) hosted a webinar titled “New TSCA at 3: Key Implementation Issues” led by B&C’s Managing Partner, Lynn L. Bergeson. Webinar speakers included the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator, Alexandra Dapolito Dunn, and B&C’s Director of Chemistry and former EPA staff, Richard E. Engler, Ph.D. Assistant Administrator...