The U.S. Environmental Protection Agency (EPA) held a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar provided a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key per- and polyfluoroalkyl substances (PFAS) research needs for environmental decision-making. During the webinar, ORD scientists highlighted two recently released data sources:...
Category: TSCA
On July 5, 2022, the U.S. Environmental Protection Agency (EPA) issued a final rule amending the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align with revisions that were made to the Occupational Safety and Health Administration (OSHA) Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification...
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker...
July 21, 2022
Draft Revision to Risk Determination for 1-BP Finds 1-BP, as a Whole Chemical Substance, Presents an Unreasonable Risk
On July 20, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 43265. EPA states that the draft revision to the 1-BP risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported...
The U.S. Environmental Protection Agency (EPA) issued a final rule on July 18, 2022, updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 42651. The final rule updates the regulations to identify five per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA)...
The U.S. Environmental Protection Agency (EPA) recently released draft revisions to the risk determinations for perchloroethylene (PCE) (87 Fed. Reg. 39085), N-methylpyrrolidone (NMP) (87 Fed. Reg. 39511), methylene chloride (87 Fed. Reg. 39824), and trichloroethylene (TCE) (87 Fed. Reg. 40520). Each draft revision to the risk determinations for these chemicals reflects EPA’s announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is...
The U.S. Environmental Protection Agency (EPA) published on June 29, 2022, the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 38746. EPA will evaluate the conditions of use (COU) of asbestos, including other types of asbestos fibers in addition to chrysotile, that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any COUs of...
On June 29, 2022, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Six Years Later.” This virtual conference marked the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics,...
June 30, 2022
Final Revision to HBCD Risk Determination Finds HBCD, as a Whole Chemical Substance, Presents an Unreasonable Risk
The U.S. Environmental Protection Agency (EPA) announced on June 29, 2022, the availability of the final revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 38747. The revision reflects EPA policy changes intended to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA states that it determined that “HBCD,...
June 27, 2022
EPA Announces New Chemical Engineering Initiative Intended to Increase Transparency and Reduce Rework
The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions that is caused by submitters...
On June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” The Committee’s only witness was Michal Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Freedhoff’s written testimony...
The U.S. Environmental Protection Agency (EPA) announced on June 6, 2022, that it issued the first in a series of Toxic Substances Control Act (TSCA) test orders to require companies to conduct and submit testing on per- and polyfluoroalkyl substances (PFAS). EPA issued the order as part of its PFAS Strategic Roadmap. When EPA announced the Strategic Roadmap to confront PFAS contamination nationwide, it also released the National PFAS Testing Strategy to help identify...
The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on May 17, 2022, on the fiscal year (FY) 2023 budget for the U.S. Environmental Protection Agency (EPA), and the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a separate hearing on May 18, 2022. EPA Administrator Michael S. Regan was the only witness at each hearing. The hearings included questions about EPA’s...
On May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and...
On May 6, 2022, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for asbestos under Section 8(a) of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 27060. EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) in the four years prior to the date of publication of the final rule to report electronically certain exposure-related...
On April 29, 2022, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing on President Biden’s fiscal year (FY) 2023 budget request for the U.S. Environmental Protection Agency (EPA). In his written testimony, EPA Administrator Michael S. Regan notes that “[c]hemicals and toxic substances are ubiquitous in our everyday lives and are often released into the environment from their manufacture, processing...
On April 20-21, 2022, the U.S. Environmental Protection Agency (EPA) held a virtual public meeting to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and...
April 12, 2022
Senate Committee Hearing on Proposed FY 2023 EPA Budget Includes Discussion of TSCA and FIFRA Issues
The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states that EPA has significant responsibilities under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and addressing...
On April 6, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “New Chemical Risk Management Actions under TSCA.” The slides include an embedded voiceover recording of the webinar. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this...
The U.S. Environmental Protection (EPA) announced on April 5, 2022, that it will propose to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. EPA notes that the proposed rule will be “the first-ever risk management rule issued under the new process for evaluating and addressing the safety of existing chemicals under the Toxic Substances Control Act (TSCA) that was enacted in 2016.” EPA will propose to prohibit...
March 17, 2022
EPA Actions to Address PFAS in Commerce Include TSCA Compliance Notification Letter on PFAS in HDPE Containers
On March 16, 2022, the U.S. Environmental Protection Agency (EPA) announced two actions intended to safeguard communities from products containing per- and polyfluoroalkyl substances (PFAS). First, as part of EPA’s efforts to identify, understand, and address PFAS contamination leaching from fluorinated containers, EPA states that it is notifying companies of their obligation to comply with existing requirements under the Toxic Substances Control Act (TSCA) to ensure unintentional...
March 14, 2022
EPA Posts Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA”
As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to...
March 8, 2022
EPA Publishes Final Scope of D4 Risk Evaluation, Seeks Comment on Draft Revision to PV29 Risk Determination
On March 7, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4), a chemical substance for which EPA received a manufacturer request for risk evaluation under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12696. The scope document includes the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS)...
The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, that EPA Administrator Michael S. Regan signed a final rule on March 3, 2022, that will amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). EPA states that it is extending the compliance date applicable to the prohibition on processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to...
On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received...
January 24, 2022
EPA Requests Comment on Draft TSCA Screening Methodology to Evaluate Chemical Exposures and Risks to Fenceline Communities
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comments on the “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). 87 Fed. Reg. 3294. EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA)...
December 30, 2021
EPA Publishes Draft Scope of the Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos
The U.S. Environmental Protection Agency (EPA) announced on December 29, 2021, the availability of the Draft Scope of the Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos (Draft Scope). 86 Fed. Reg. 74088. In the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and...
December 29, 2021
Draft Revision to Risk Determination for HBCD Retains Finding of Unreasonable Risk of Injury
On December 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 74082. EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable...
December 21, 2021
EPA Intends Draft TSCA Systematic Review Protocol to Strengthen Science Used in Chemical Risk Evaluations
On December 20, 2021, the U.S. Environmental Protection Agency (EPA) released the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) for public comment. 86 Fed. Reg. 71891. According to EPA’s press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations and ensure that...
On December 2, 2021, the U.S. Environmental Protection Agency (EPA) published an updated New Approach Methods (NAM) Work Plan (Updated Work Plan). EPA created the work plan to prioritize its efforts and resources toward activities that aim to reduce the use of vertebrate animal testing while continuing to protect human health and the environment. EPA describes its updated roadmap and identifies steps intended to reduce the use of vertebrate animals for toxicity testing and related research...
On December 7, 2021, the House Science, Space, and Technology Subcommittees on Environment and on Research and Technology held a joint hearing entitled “Forever Chemicals: Research and Development for Addressing the PFAS Problem.” Four witnesses spoke before the subcommittees on their respective knowledge of the current state of per- and polyfluoroalkyl substances (PFAS) and where each felt future actions should be focused: Dr. Elsie Sunderland, Gordon McKay Professor of...
October 28, 2021
House Committee Holds Hearing on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act”
The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended the Toxic Substances Control Act (TSCA), “including key reforms to increase [the U.S. Environmental Protection Agency’s (EPA)]...
October 25, 2021
EPA Proposes Further Extension of Compliance Dates for PIP (3:1)-Containing Articles
The U.S. Environmental Protection Agency (EPA) announced on October 21, 2021, that it is proposing to extend further the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted. As reported in our September 3, 2021, memorandum that addresses a September 17, 2021, final rule, EPA provided a short-term extension of certain compliance dates for PIP (3:1)...
October 21, 2021
Senate Committee Holds Hearing on “Evaluating the Federal Response to the Persistence and Impacts of PFAS Chemicals on our Environment”
On October 20, 2021, the Senate Committee on Environment and Public Works held a hearing on “Evaluating the Federal Response to the Persistence and Impacts of PFAS Chemicals on our Environment.” The sole witness called before the Committee was the U.S. Environmental Protection Agency (EPA) Assistant Administrator for the Office of Water, Radhika Fox. The focus of the hearing was to address the recently released EPA Strategic Roadmap for per- and polyfluoroalkyl substances (PFAS)....
October 19, 2021
Biden Administration Announces Multi-Agency Plan to Confront PFAS Pollution; EPA Releases Strategic Roadmap
On October 18, 2021, the Biden Administration announced a multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination nationwide. According to the White House, agencies, including the U.S. Environmental Protection Agency (EPA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the Department of Health and Human Services (DHHS), will take actions to...
The U.S. Environmental Protection Agency (EPA) announced on September 3, 2021, that it intends to initiate a new rulemaking and anticipates proposing new rules for five persistent, bioaccumulative, and toxic (PBT) chemicals that are the subject of final risk management rules under the Toxic Substances Control Act (TSCA). Additionally, and importantly, EPA is extending the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of...
On August 31, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope documents for the manufacturer-requested risk evaluations (MRRE) of di-isodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. The scope documents include the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk...
August 5, 2021
EPA Will Delay 1,4-Dioxane Risk Management until Nearing Completion of Reconsideration of Risk Evaluation
In a July 30, 2021, filing in the U.S. Court of Appeals for the Ninth Circuit, the U.S. Environmental Protection Agency (EPA) states that it cannot “meaningfully commence” risk management rulemaking for 1,4-dioxane until it nears completion of its reconsideration of the final risk evaluation. EPA released the final risk evaluation for 1,4-dioxane on January 8, 2021, in the final weeks of the Trump Administration. On June 30, 2021, the Biden-Harris EPA announced several policy...
The U.S. Environmental Protection Agency (EPA) convened a public webinar on July 27, 2021, to engage with stakeholders on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. According to the July 14, 2021, Federal Register notice announcing the webinar, EPA currently...
On June 30, 2021, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform - Five Years Later.” This virtual conference marked the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics,...
June 29, 2021
Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA
The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to...
The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three...
On March 1, 2021, the White House Office of Management and Budget (OMB) received for review under Executive Order 12866 (Regulatory Planning and Review) from the U.S. Environmental Protection Agency (EPA) a proposed rule entitled “Reporting and Recordkeeping for Perfluoroalkyl or Polyfluoroalkyl Substances Under Section 8(a)(7) of the Toxic Substances Control Act (TSCA)” (Proposed Rule). This action is required under Section 7351 of the National Defense...
On May 12, 2021, the Senate Committee on Environment and Public Works held a hearing on several Department of the Interior and U.S. Environmental Protection Agency (EPA) nominees, including Michal Freedhoff, Ph.D., to be Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In her opening statement, Dr. Freedhoff stated that during her time working for the legislative branch, she believes that she “earned a reputation for being fair,...
March 12, 2021
EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater
On February 8, 2021, the U.S. Environmental Protection Agency (EPA) received a petition seeking a rule reversing EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The petition also urges EPA to promulgate regulations under RCRA Subtitle C governing the safe treatment, storage, and disposal...
On March 10, 2021, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “The Path Forward: Restoring the Vital Mission of EPA.” According to the March 7, 2021, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee, to the Subcommittee, the U.S. Environmental Protection Agency’s (EPA) current responsibilities include reviewing national air pollution standards and overseeing or carrying out cleanups at most of the...
February 1, 2021
EPA Issues TSCA Section 4 Test Orders for Nine Chemicals Undergoing Risk Evaluation
The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing the available data on these chemicals, it needs additional data and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation...
January 25, 2021
EPA Completes Final Risk Evaluation for PV29, Finding Unreasonable Risks to Workers and ONUs from Ten Uses
The U.S. Environmental Protection Agency (EPA) announced on January 14, 2021, the release of the final risk evaluation for C.I. Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA), meeting a “major chemical safety milestone.” In the risk evaluation, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used...
The U.S. Environmental Protection Agency (EPA) announced on January 12, 2021, that it signed a memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) “that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).” The goal of the MOU is to improve the combined efforts of the agencies to protect workers who may be exposed to a new chemical substance by providing guidelines for...
January 13, 2021
Final Risk Evaluation for 1,4-Dioxane Finds Unreasonable Risk to Workers for Certain Uses
On January 8, 2021, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for 1,4-dioxane. 86 Fed. Reg. 1495. The final risk evaluation identifies unreasonable risk to workers for 13 out of 24 conditions of use. EPA states that it found no unreasonable risk to the general population and the environment. EPA notes that it also published a supplemental analysis to the draft risk evaluation that evaluated eight additional conditions of use for 1,4-dioxane...