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The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). EPA states that it recognizes its responsibility to identify and implement...

Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit the U.S. Environmental Protection Agency’s (EPA) authority in implementing Congress’s 2016 amendments to the Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The...

On June 22, 2022, the Senate Committee on Environment and Public Works will hold a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety...

The House Energy and Commerce Subcommittee on Environment and Climate Change will hold a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” According to the October 20, 2021, press release issued by the House Committee on Energy and Commerce, Representatives Frank Pallone, Jr. (D-NJ), Chair of the Committee, and Paul Tonko (D-NY), Chair of the Subcommittee, stated that the Frank R. Lautenberg Chemical Safety for the 21st Century Act...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) is scheduled to publish a final rule on May 18, 2021, that will rescind the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a final rule on May 18, 2021, that will rescind the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts...

On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation.  According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals.  GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address...

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for...

On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.”  The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for...

As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA).  Environmental Defense Fund v. Wheeler, No. 1:20-cv-762.  On July 27, 2020, the parties submitted a joint case...

This week’s All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois.  As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee.  In this capacity, Congressman...

On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020.  Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first...

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator,...

On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler requesting information on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).  The letter notes that the Lautenberg Act was intended to enact reforms addressing “longstanding structural problems” with...

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 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...

On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, the U.S. Environmental Protection Agency (EPA) announced that it is seeking nominations for individuals who represent small businesses, small governments, and small non-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation.  EPA states the role of a SER is “to provide advice and...

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s...

On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting.  EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on...

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on...

On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments.  The meetings are: Online requests to participate in either meeting must be received on or...

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested...

On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.   EPA’s proposed rule describes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to...

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use.  The process would not consider costs or other nonrisk factors.  Risk evaluation is the second step, after...

As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act...

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called...

On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage.  This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans.  EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30,...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA).  The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182.  EPA notes that the new law imposes new responsibilities on EPA,...

On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track...

The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials...

On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate...

The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and...