Blogs

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages...

The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential...

review of a proposed rule that would designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Such designations would require facilities to report on PFOA and PFOS releases that meet or exceed the reportable quantity. Publication of the proposed rule in the Federal Register will begin a public comment period. As reported in our October 19,...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on July 26, 2022, that it “has achieved a significant milestone in decreasing the minimum fuel selling price (MFSP) of drop-in biofuels, which are fuels made from biomass and other waste carbon sources, and that are compatible with existing petroleum fuel infrastructure and conventional vehicles.” BETO partnered with T2C-Energy, LLC (T2C) to...

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review...

The U.S. Environmental Protection Agency (EPA) published a supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 48128. EPA previously issued a proposed rule on September 5, 2000, in response to a petition filed under EPCRA, to add a DINP category to the list of...

By Lynn L. Bergeson and Carla N. Hutton The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” EPA states that “[a] growing body of scientific evidence suggests that exposure at certain levels to specific [per- and polyfluoroalkyl substances (PFAS)] can adversely impact human health and other living things.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s...

The White House Office of Science and Technology Policy (OSTP) released on August 5, 2022, a new report on the National Emerging Contaminants Research Initiative (NECRI). The report outlines a federal strategy to address critical research gaps related to detecting and assessing emerging contaminants in drinking water, as well as identifying and mitigating the adverse health effects those contaminants cause. The report also outlines strategic steps needed to more effectively...

The U.S. Environmental Protection Agency (EPA) has posted two new resource documents for recipients of test orders under Section 4 of the Toxic Substances Control Act (TSCA). The August 5, 2022, policy document entitled “Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing” provides two policies: The August 5, 2022, policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022” states that although EPA’s...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency (EPA) announced on August 1, 2022, a 15-day public comment period on two additional peer review candidates for the external peer review of the Biofuels and the Environment: Third Triennial Report to Congress (RtC3). 87 Fed. Reg. 46958. EPA previously requested comment on an initial pool of 20 candidates announced in a May 9, 2022, Federal Register notice. EPA states that after considering public...

Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995. During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of...

By Lynn L. Bergeson and Carla N. Hutton According to an item in the U.S. Department of Agriculture’s (USDA) Unified Agenda, which was published on June 21, 2022, USDA intended to publish in June 2022 a proposed rule that would codify BioPreferred Program guidance. According to the item, USDA expects this action to reduce burden on both it and the applicants by reducing requirements, clarifying requirements, streamlining the application and certification process, and...

The German Federal Ministry of Education and Research (BMBF) project (DaNa4.0) is addressing the question of whether new advanced materials, including nanomaterials, can be harmful to humans and the environment and how humans and the environment come into contact with these materials. DaNa has published an August 2022 research spotlight on a “Three-stage model for the formation of micro- and nanoplastic particles.” The paper, “Degradation of low-density polyethylene to nanoplastic...

On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website: According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database....

The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging...

On July 29, 2022, the National Institute for Occupational Safety and Health (NIOSH) published a Technical Report: Occupational Exposure Sampling for Engineered Nanomaterials. Since 2010, NIOSH has developed guidance for workplace sampling for three engineered nanomaterials: carbon nanotubes (CNT) and nanofiber (CNF), silver, and titanium dioxide, each of which has an elemental mass-based NIOSH recommended exposure limit (REL). NIOSH has also developed a practical approach to...

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...

The National Nanotechnology Initiative (NNI) and the U.S. Environmental Protection Agency (EPA) will co-host a webinar on August 25, 2022, on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities for water nanotechnologies. Small businesses and academic researchers will have an opportunity to hear from some of the federal agencies that fund water technologies, with a special focus on investments in nanotechnology-enabled solutions. The...

The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by...

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...

The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft...

On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup®, which contains the active ingredient glyphosate,...

The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures — Project Report. Part of OECD’s series on chemical accidents, the document presents the outcome from a project of the OECD Working Party on Chemical Accidents (WPCA) that aimed to investigate safety issues related to the prevention of, preparedness for, and response to...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 – 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss...

By Lynn L. Bergeson 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 caused...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 – 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022,...

The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles. The request notes that titanium dioxide is authorized...

The U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG)...

On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in research and development (R&D) regarding several aspects of per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal...

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier states that in many cases, novel materials offer solutions to environmental...

On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on...

On July 6, 2022, the U.S. Environmental Protection Agency (EPA) released a proposed consent decree intended to resolve the case, Center for Food Safety, et al. v. U.S. Environmental Protection Agency (3:21-cv-09640-JSC), brought against EPA in the United States District Court for the Northern District of California alleging that EPA has unreasonably delayed responding to a petition for rulemaking relating to the regulatory exemption of pesticide treated seed.  87...

Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA New Approach Methodologies,” a complimentary webinar featuring Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH. The 2016 amendments to TSCA require EPA “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the...

On July 7, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled “The EPA Was Not Transparent About Changes Made to a Long-Chain PFAS Rule After Administrator Signature.” OIG evaluated the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances (LCPFAC) significant new use rule (SNUR) between the EPA...

By Lynn L. Bergeson On June 23, 2022, DOE’s Office of Energy Efficiency & Renewable Energy (EERE) issued a funding opportunity announcement (FOA) of $70 million to establish the 7th Clean Energy Manufacturing Innovation Institute. DOE EERE states that “[t]his new coalition of industry, academia, and government partners aims to develop and scale technologies to electrify industrial process heating and reduce emissions across the industrial sector.” The institute along...

By Lynn L. Bergeson The U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) announced recently a new program that directs USDA to partner with at least one qualified institution to support the scale-up of sustainable bioproduct manufacturing. Up to $5 million is available for each of the fiscal years (FY) 2022 and 2023. NIFA will work in collaboration with USDA Rural Development’s BioPreferred program to seek research proposals that explore...

The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. The following presentations from the conference have been posted online....

The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better...

On June 30, 2022, the Organization for Economic Cooperation and Development (OECD) published six new Test Guidelines (TG) and ten updated or corrected TGs. The new TGs include the first two harmonized methods for measuring certain nanomaterial-specific physical-chemical properties. According to OECD, these harmonized methods were developed to respond to regulatory needs in member and adhering countries, specifically for manufactured nanomaterials. The development of these TGs was...

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI). Proposed Rule Stage Final Rule Stage...

The U.S. Environmental Protection Agency (EPA) announced on July 6, 2022, that it is inviting small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel that will focus on EPA’s development of a proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process. EPA states that the proposed rule would establish a framework of reporting...

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...

On July 1, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2019 (2019 Report).  87 Fed. Reg. 39517.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2019...

On June 28, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Models to Characterize Exposures to Manufactured Nanomaterials in OECD” by Vladimir Murashov, Ph.D., Senior Scientist in the Office of the Director, National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., Director of NIOSH and Administrator of the World Trade Center Health Program in the U.S. Department of Health and Human Services. The authors...

By Lynn L. Bergeson On June 22, 2022, the Senate Committee on Environment and Public Works held 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 TSCA. The only witness present was Michal Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The recording of...

As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The Internal Revenue Service (IRS) announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The IRS released Revenue Procedure 2022-26, which provides the exclusive procedures for requesting a determination under Section 4672(a)(2) of the...

The latest episode of Bergeson & Campbell, P.C.’s (B&C®) All Things Chemical® podcast, “Balancing Wildlife Protection and Responsible Pesticide Use — A Conversation with Jake Li,” features a conversation with Jake Li, Deputy Assistant Administrator for Pesticide Programs, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Conversation topics include what the Administration is doing to balance wildlife protection and...

The Internal Revenue Service announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The FAQs detail what the Superfund chemical excise tax is, how the tax is computed, and who may be liable for the tax. The Superfund chemical taxes will be reported on Form 720, Quarterly Federal Excise Tax Return, and Form 6627, Environmental Taxes. The excise taxes were reinstated beginning on July 1, 2022, under...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 17, 2022, that it is looking for topics that could be addressed in its upcoming studies. EUON conducts up to three studies annually to address knowledge gaps on nanomaterials. EUON is looking for study topics that address: EUON states that the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. Studies are run for three to...