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On April 14, 2023, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a request for feedback on its recycled plastics policy. 88 Fed. Reg. 23140. PHMSA states that it published the notice to solicit information pertaining to how the potential use of recycled plastic resins in the manufacturing of specification packagings may affect hazardous materials transportation safety; ensure transparency of its current policy pertaining...
April 13, 2023
EPA Publishes ANPRM Seeking Information to Assist in Consideration of Future CERCLA Regulations Regarding PFAS
The U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) on April 13, 2023, seeking information to assist in the consideration of potential development of future regulations pertaining to per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 88 Fed. Reg. 22399. EPA states that it seeks input and data regarding potential future hazardous substance designation under...
April 7, 2023
ECHA Convenes Online Information Session Regarding the Proposal to Restrict More than 10,000 PFAS under REACH
On April 5, 2023, the European Chemicals Agency (ECHA) convened an online information session as part of the consultation period regarding the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The speakers during the information session explained how the REACH restriction process works, provided details regarding the restriction proposal, and described how...
April 6, 2023
EPA’s New Chemicals Program Holds Second Webinar in Series on Standardized Approach for MMOs in New and Modified CAMs
On March 30, 2023, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program (NCP) held the second of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to...
On March 29, 2023, the Internal Revenue Service (IRS) published a notice of proposed rulemaking (NPRM) relating to the Superfund excise taxes imposed on certain chemicals and certain imported substances, effective July 1, 2022. 88 Fed. Reg. 18446. There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” The NPRM contains proposed regulations under Sections 4661,...
On March 28, 2023, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). EPA Administrator Michael Regan was the Committee’s only witness. As reported in our March 14, 2023, blog item, according to EPA’s March 9, 2023, press release, President Biden’s budget requests over $12 billion in discretionary budget authority for EPA in...
The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on the U.S. Environmental Protection Agency’s (EPA) fiscal year (FY) 2024 budget proposal. EPA Administrator Michael Regan was the Committee’s only witness. In his written testimony, Regan notes 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 to address...
On March 17, 2023, the U.S. Environmental Protection Agency (EPA) released additional data related to the proposed risk management rule for chrysotile asbestos for public comment. 88 Fed. Reg. 16389. According to EPA’s March 16, 2023, press release, these data concern chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA states that it may use the data in the development of the final rule,...
On March 14, 2023, the U.S. Environmental Protection Agency (EPA) held the first of two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA’s March 2, 2023, press release, EPA will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the...
On March 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will propose the first-ever national drinking water standard for six per- and polyfluoroalkyl substances (PFAS) in the latest action under EPA’s PFAS Strategic Roadmap. The proposed National Primary Drinking Water Regulation (NPDWR) would regulate perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as individual contaminants and will regulate four other PFAS —...
On February 28, 2023, the U.S. Environmental Protection Agency (EPA) New Chemicals Program held the third and final webinar in its series on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar covered commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at...
On February 27, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on two draft documents that are being submitted to the Science Advisory Committee on Chemicals (SACC) for peer review: “Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act” (draft proposed principles) and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested...
February 24, 2023
GAO Report Finds Workforce Planning Gaps Contributed to EPA’s Missed TSCA Deadlines
The U.S. Government Accountability Office (GAO) released a report on February 23, 2023, entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines.” GAO evaluated the extent to which the U.S. Environmental Protection Agency (EPA) met selected Toxic Substances Control Act (TSCA) deadlines for reviewing existing and new chemicals since June 2016, and to which EPA engaged in workforce planning for implementing its chemical review responsibilities. GAO identified...
On February 14, 2023, the Maine Department of Environmental Protection (MDEP) announced a much anticipated proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). MDEP will hold a public hearing on April 20, 2023. Comments are due May 19, 2023, by 5:00 p.m. (EDT). Background Maine enacted “An Act To...
On February 7, 2023, the European Chemicals Agency (ECHA) announced the availability of a much anticipated detailed proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden (dossier submitters) submitted the proposal after finding risks in the manufacture, placement on the...
On February 3, 2023, the Turkish Ministry of Environment, Urbanization and Climate Change (MoEUCC) released new guidance on the registration requirements under the KKDIK regulation (Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması). As a result of this new guidance, providing importer information for the registration of a substance is now optional instead of mandatory, the chemical safety report (CSR) may be submitted in English, and there is additional time after the...
On January 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for those per- and polyfluoroalkyl substances (PFAS) that are currently on the Toxic Substances Control Act (TSCA) Inventory but that have not been actively manufactured (including imported) or processed in the United States since 2006 and are consequently designated as inactive on the TSCA Inventory. 88 Fed. Reg. 4937. Persons subject to the SNUR would be required to notify...
On January 17, 2023, the Health and Safety Executive (HSE) began a public consultation on changes to the data requirements in the Great Britain (GB) Biocidal Products Regulation (GB BPR). GB BPR applies to the supply and use of biocidal products. Biocidal products are products that control harmful organisms, and include insecticides, rodenticides, wood preservatives, anti-fouling coatings on ships, disinfectants, and hand sanitizers. HSE is consulting on proposed revisions to Annexes...
The U.S. Environmental Protection Agency (EPA) announced on January 19, 2023, the availability of and solicited public comment on a draft white paper entitled “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” 88 Fed. Reg. 3406. EPA states that it developed the draft white paper pursuant to the Federal, Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a screening program to determine whether certain substances may...
January 23, 2023
EPA Announces Next Test Order Issued under National Testing Strategy for PFAS Used in Plastics, Chemical Manufacturing
The U.S. Environmental Protection Agency (EPA) announced on January 4, 2023, that it issued the next Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. The test order requires companies to conduct and submit testing on trifluoro(trifluoromethyl)oxirane (HFPO), a perfluoroalkyl substance used in making plastics. EPA states that this is “the second test order under the strategy...
January 19, 2023
EPA Finds TCE, as a Whole Chemical Substance, Poses an Unreasonable Risk to Human Health
The U.S. Environmental Protection Agency (EPA) announced on January 9, 2023, the availability of the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 1222. EPA determined that TCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). EPA states that the revision to the risk determination reflects its...
January 18, 2023
Congress Enacts Modernization of Cosmetics Regulation Act of 2022, Significantly Strengthening Regulation of Cosmetics
In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MoCRA significantly strengthens the U.S. Food and Drug Administration (FDA) authority over cosmetic products. Key impacts are summarized below. Background On April 16, 2021, the Performance Enhancement Reform Act was introduced to the House of Representatives by Representative Gerald E. Connolly (D-VA)....
On January 4, 2023, the Department of Health in Canada published in the Canada Gazette, Part II the revisions to the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the classification, labeling, and Safety Data Sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The current HPR is based on the fifth revised edition (Rev 5) of the United Nations (UN) Globally Harmonized...
Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2023, our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. We have worked hard to offer our best-informed judgment on the trends...
December 21, 2022
EPA Finds PCE, NMP, and 1-BP, as Whole Chemical Substances, Pose Unreasonable Risks to Human Health
The U.S. Environmental Protection Agency (EPA) announced on December 14, 2022, the availability of the final revision to the risk determination for the perchloroethylene (PCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 76481. EPA determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). On December 19, 2022, EPA announced the availability of the final...
December 16, 2022
FTC Seeks Public Comment on Potential Updates to the Green Guides, Will Begin 60-Day Comment Period in January 2023
The Federal Trade Commission (FTC) announced on December 14, 2022, that it is seeking public comment on potential updates and changes to the Guides for the Use of Environmental Marketing Claims (Green Guides). FTC intends the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. FTC states that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally...
December 12, 2022
PHMSA Publishes First Set of FAQs Specific to HMR Applicability, Will Address Incident Reporting Requirements Next
On December 9, 2022, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a notice responding to comments received on its initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ). 87 Fed. Reg. 75694. PHMSA also issued the first set of FAQs in final and...
December 7, 2022
EPA Proposes to Add PFAS Subject to TRI Reporting to List of Chemicals of Special Concern
The U.S. Environmental Protection Agency (EPA) proposed on December 5, 2022, to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). 87 Fed. Reg. 74379. EPA notes that these PFAS already have a...
December 6, 2022
European General Court Annuls Harmonized Classification and Labeling of Titanium Dioxide
On November 23, 2022, the Court of Justice of the European Union (EU) announced a decision of the General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. According to the press release, the European Commission (EC) “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion...
November 29, 2022
EPA Seeks Comment on Initial Regulatory Flexibility Analysis on Proposed PFAS Reporting Rule
On November 25, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis following the completion of a Small Business Advocacy Review (SBAR) Panel for the Toxic Substances Control Act (TSCA) proposed rule for reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 72439. EPA states that it seeks...
November 28, 2022
EPA Finds Carbon Tetrachloride, as a Whole Chemical Substance, Poses an Unreasonable Risk to Human Health
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2022, the availability of the final revision to the risk determination for the carbon tetrachloride risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 79303. EPA determined that carbon tetrachloride, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). EPA states that the revision to the risk...
November 23, 2022
EPA Holds First Webinar on Approach for Reviewing MMOs, Including New and Modified CAMs
On November 17, 2022, the U.S. Environmental Protection Agency (EPA) held the first of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the...
On November 16, 2022, the U.S. Environmental Protection Agency (EPA) published a much-anticipated supplemental notice of proposed rulemaking (SNPRM) to modify and supplement its 2021 proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 87 Fed. Reg. 68647. EPA states that “[w]ith over five years of experience administering the TSCA amendments of 2016, EPA is publishing this document to ensure that the fees charged accurately reflect the level of effort and...
November 8, 2022
EPA Provides Report to Congress on Its Capacity to Implement Certain Provisions of the Lautenberg Act
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). TSCA Section 26(m) requires EPA to submit an initial report to Congress within...
November 4, 2022
Canada Publishes NOI on the Labeling of Toxic Substances in Products, Including Toxic Flame Retardants
On October 29, 2022, Canada published in the Canada Gazette a notice of intent (NOI) announcing that it intends to propose actions under the Canadian Environmental Protection Act, 1999 (CEPA) to require the labeling of certain substances that are listed on the CEPA Schedule 1 List of Toxic Substances in certain products, such as cosmetics, cleaning products, and flame retardants in upholstered furniture. Comments and feedback on the NOI will inform a strategy on...
On October 18, 2022, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and...
October 11, 2022
EPA Announces Initiative to Bring to Market New Chemicals Used in Electric Vehicle, Semiconductor, and Clean Energy Sectors
The U.S. Environmental Protection Agency (EPA) announced on October 5, 2022, a new effort under the Toxic Substances Control Act (TSCA) to implement a streamlined and more efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors, and renewable energy generation. The new process is for mixed metal oxides (MMO), including new and modified...
On September 20, 2022, the European Commission (EC) began a public consultation on a draft act that would introduce new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). Hazard classes and criteria would be added for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile, and toxic...
September 28, 2022
EC Opens Call for Evidence on a Proposal for a Basic Regulation for ECHA
On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023....
On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...
September 9, 2022
Final Revision to the Risk Determination for PV29 Finds that PV29, as a Whole Chemical Substance, Presents an Unreasonable Risk to Human Health
On September 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final revision to the risk determination for the Colour Index Pigment Violet 29 (PV29) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 54491. EPA states that the revision to the PV29 risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by...
On August 29, 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 carbon tetrachloride risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 52766. EPA states that the draft revision to the carbon tetrachloride risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way...
The U.S. Environmental Protection Agency (EPA) announced on August 26, 2022, that it will propose to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), “two of the most widely used per- and polyfluoroalkyl substances (PFAS),” as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The proposal will include the salts and structural isomers of PFOA and PFOS. The rulemaking would require entities...
The U.S. Environmental Protection Agency (EPA) announced on August 19, 2022, that it will propose revisions to the Risk Management Program (RMP) rule to protect further vulnerable communities from chemical accidents, especially those living near facilities with high accident rates. According to EPA, the “Safer Communities by Chemical Accident Prevention” (SCCAP) rule “would strengthen the existing program and includes new safeguards that have not been addressed in prior RMP...
August 22, 2022
EPA Will Discontinue Use of Exposure Modeling Thresholds When Assessing Health and Environmental Risks of New Chemicals
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA....
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:...
The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) held a webinar on June 27, 2022, on an initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ) on its website. A recording of the webinar is available online. During the webinar, Bill Quade, Deputy Associate...
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...
On August 5, 2022, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 87 Fed. Reg. 47947. FTC reviews its rules and industry guides on a ten-year schedule to ensure they remain relevant and not unduly burdensome. FTC publishes its review schedule each year, with adjustments made in response to public input, changes in the marketplace, and resource demands. FTC, in its discretion, may modify or reorder the schedule in the future to...
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...