On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 37702. EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rule requires persons who intend to manufacture...
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On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of...
On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). The final rule applies to any person who manufactures (including imports) mercury or...
June 25, 2018
EPA Extends Comment Period for TSCA Problem Formulation Documents and Systematic Review Document
On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days; comments on these documents are now due by August 16, 2018. EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try...
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the...
June 22, 2018
Richard E. Engler, Ph.D., Presents “New TSCA And Green Chemistry Innovation” At ACS’s GC&E Conferenc
On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), presented “New TSCA and Green Chemistry Innovation” at the American Chemical Society’s (ACS) Green Chemistry & Engineering Conference in Portland, Oregon. This presentation covered specific changes to the Toxic Substances Control Act (TSCA) and the impact of those changes for new chemicals, including innovative “green”...
June 21, 2018
EPA Issues Guidance on Points to Consider when Preparing TSCA New Chemical Notifications
On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to...
On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our May 26, 2016, memorandum, “An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA,” the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will...
June 15, 2018
BRAG Engages With EPA On Critical Nomenclature Issues
By Kathleen M. Roberts On June 13, 2018, representatives of the Biobased and Renewable Products Advocacy Group (BRAG®) and representatives of the Biotechnology Innovation Organization (BIO) met with U.S. Environmental Protection Agency (EPA) staff to discuss the two groups’ white paper, “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals.” BRAG and BIO...
On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...