All Knowledge & Insights By Date

On September 13, 2018, EPA announced it was requesting public nominations of scientific experts to be considered for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  83 Fed. Reg. 46487.  The notice states that all nominees will be considered for ad hoc participation in the TSCA SACC’s peer reviews of the EPA’s risk evaluations for the first ten chemical substances...

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...

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...

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...

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”...

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...

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)...

As reported in our June 7, 2018, memorandum, the New York State Department of Environmental Conservation (NYSDEC) on June 6, 2018, released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program.  The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative...

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment.  Links and short summaries are provided below. EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the...

By Lynn L. Bergeson On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present “New TSCA and Green Chemistry Innovation” at the 22nd Annual Green Chemistry & Engineering Conference (GC&E), hosted by the American Chemical Society’s (ACS) Green Chemistry Institute®. GC&E will highlight product innovation using greener chemistries and provide an opportunity for a diverse group of academic,...

The Organization for Economic Cooperation and Development (OECD) published a May 17, 2018, document entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The document compiles information provided by delegations for the February 2018 OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on current developments on the safety of manufactured nanomaterials.  It aims to summarize relevant information on activities related to...

On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget.  The budget was plainly not the primary topic as the House Committee Members covered a lot of ground.  Pruitt fielded many questions and comments from House Democrats on his alleged...

On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people.  Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental,...

On March 2, 2018, Lauren M. Graham, Ph.D., Manager of the Biobased and Renewable Products Advocacy Group (BRAG®), presented “Advocating for Commercialization of Biobased Products” at the 2018 Advanced Bioeconomy Leadership Conference (ABLC2018).  Dr. Graham presented as part of the “Federal Perspective & Programs Forum” alongside four other panelists.  Dr. Graham provided an overview of the Toxic Substances Control Act (TSCA) regulation impacting...

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA...

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