Blogs

On August 20, 2024, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) ) under the Toxic Substances Control Act (TSCA) for chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture notices (PMN) and a Microbial Commercial Activity Notice (MCAN) and are also subject to a TSCA Order. 89 Fed. Reg. 67368. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any...

The National Science Foundation’s (NSF) Biomaterials Program published a request for information (RFI) on August 20, 2024. NSF requests input from stakeholders on opportunities, challenges, emerging areas, and frontiers in biomaterials research. 89 Fed. Reg. 67498. According to NSF, the RFI will help inform future program directions, new initiatives, and potential funding opportunities. The Biomaterials Program supports fundamental materials research related to biological materials;...

As part of its implementation of the modernized Canadian Environmental Protection Act, 1999 (CEPA), on August 17, 2024, Health Canada published a Canada Gazette notice announcing the availability of its Science Approach Document -- Chemical Screening and Prioritization: Health Canada's Automated Workflow for Prioritization (HAWPr). The science approach document (SciAD) describes the scientific approach that Canada applied to more than 25,000 chemicals on the Domestic Substances List (DSL) to...

The Internal Revenue Service (IRS) announced on August 14, 2024, a correction to the stoichiometric material consumption equation in the notice of filing for the nylon 6 petition that was published in the February 22, 2024, Federal Register. 89 Fed. Reg. 66175. According to the notice, after the comment period for the original notice closed, an error was discovered in the stoichiometric material consumption equation for nylon 6, and the petitioner subsequently provided a corrected petition....

The Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) published a blog item on August 14, 2024, announcing the availability of a report highlighting examples of agencies seeking to strengthen public participation and community engagement in the regulatory process. According to OIRA, while agencies have adopted a range of approaches depending on the type of action under consideration and the stakeholders they are seeking to engage, there are four...

On August 8, 2024, the U.S. Environmental Protection Agency announced that it made updates to strengthen the Safer Choice and Design for the Environment (DfE) Standard, which identifies the requirements that products and their ingredients must meet to earn EPA’s Safer Choice label or DfE logo. EPA states these updates strengthen the criteria that products must meet to qualify for the voluntary Safer Choice label, supporting the use of safer chemicals in the marketplace. According to EPA, the...

The U.S. Environmental Protection Agency (EPA) announced on August 7, 2024, that it will hold a webinar on August 28, 2024, on the use of new approach methodologies (NAM). The webinar, “The CATMoS Model for Acute Oral Toxicity and Evaluation of its Potential Use in a Regulatory Context for Pesticide Hazard and Risk Assessment,” is the fifth in a series held in collaboration with PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California...

On August 1, 2024, Senators Sherrod Brown (D-OH) and Pete Ricketts (R-NE) introduced the Renewable Chemicals Act of 2024 (S. 4931), bipartisan legislation that would “advance the manufacturing of renewable biochemicals from domestic biomass in the United States by creating a tax credit for the production of these chemicals by American companies.” According to Brown’s August 13, 2024, press release, the legislation would help to build new markets for domestically produced biomass, advance...

On August 2, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced a new flexibility for BRS importation permits in APHIS eFile. APHIS states that it has implemented a new flexibility allowing permit holders to reuse import labels. According to APHIS, permit holders no longer need to request additional labels if they have used all the import labels received with their permit. APHIS notes that...

The U.S. Environmental Protection Agency (EPA) is seeking applications for research to develop and demonstrate nanosensor technology with the potential to detect, monitor, and degrade per- and polyfluoroalkyl substances (PFAS) in groundwater or surface water that may be used as drinking water sources. EPA states that advances in nanoscience and nanotechnology have the potential to address the challenges of detection and treatment of PFAS-contaminated waters. Because nanomaterials are smaller in...

Bergeson & Campbell, P.C. (B&C®) is pleased to present the on-demand recording for “Determining PFAS Content in Your Supply Chain and Expanding Data Collection Practice,” a complimentary webinar covering the basics of the U.S. Environmental Protection Agency’s (EPA) reporting rule for per- and polyfluoroalkyl substances (PFAS). With Chemical Data Reporting (CDR) wrapping up this fall, companies still have time to gather the necessary information regarding PFAS to begin reporting...

The U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. FDA states that this includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. According to FDA, this is intended to guide its post-market assessment work going forward and...

On July 29, 2024, the California Department of Pesticide Regulation (DPR) announced that it will move forward with an emergency rulemaking package to revise the fees for pesticide registrations and renewals in late August with a proposed effective date of no later than October 1, 2024. DPR states the fee increase is necessary to meet current baseline funding needs and the new positions approved as part of the Fiscal Year (FY) 2024-2025 budget. DPR states that the Governor’s Proposed 2024-2025...

The U.S. Consumer Product Safety Commission (CPSC) announced on July 30, 2024, that it issued a Decision and Order against Amazon.com, Inc. (Amazon). CPSC states that, in a unanimous vote, it “determined that Amazon was a ‘distributor’ of products that are defective or fail to meet federal consumer product safety standards, and therefore bears legal responsibility for their recall.” According to CPSC, more than 400,000 products are subject to the Order, specifically faulty carbon...

The National Institute for Occupational Safety and Health (NIOSH) posted a blog item on August 1, 2024, entitled “When Nanoparticles Blow Up -- Explosion Hazards of Nanoparticles.” According to the blog item, little is known about the potential explosivity of any material when subdivided down to the nanoscale, prompting the NIOSH Nanotechnology Research Center (NTRC) to study the explosivity of several classes of nanoparticles: Nanocarbons: NIOSH screened single-walled carbon nanotubes,...

On July 31, 2024, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the release of the first two parts of the Sustainable Aviation Fuel (SAF) State-of-Industry Report. Released by the National Renewable Energy Laboratory (NREL) in partnership with BETO, the report focuses on how to achieve the near-term fuel production goals set forth in the SAF Grand Challenge, a joint effort between DOE, the U.S. Department of Agriculture (USDA), the U.S. Department of...

The 2024 National Institute for Occupational Safety and Health (NIOSH) Nanotechnology Research Center (NTRC) Nanotechnology Health and Safety Summit will be held October 9-10, 2024. During the conference, industry, academic, and government experts will share the latest advancements in occupational exposure to nanotechnology and advanced materials. The conference will also address critical safety and health challenges and offer valuable insights and foresights on a range of cutting-edge topics,...

The Agile BioFoundry’s (ABF) 2024 Industry Day will be held virtually on September 12, 2024. Funded by the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO), ABF aims to develop biomanufacturing tools, processes, and partnerships that enable sustainable industrial production of renewable fuels and chemicals. Attendees will: Learn about ABF’s strategy to support U.S. biomanufacturing and current industry needs; Discover ABF’s biomanufacturing tools; Hear more about...

On July 25, 2024, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed suit against the U.S. Environmental Protection Agency (EPA) in the U.S. District Court for the District of Columbia seeking a rule under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the production of perfluorooctanoic acid (PFOA) during Inhance Technologies, LLC’s (Inhance) fluorination process. As reported in our May 23, 2024, blog item on their...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting on November 14, 2024. The meeting will take place in person at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland, with an option for virtual attendance. The meeting will include updates on: Highlights from fiscal year 2024; Priorities for fiscal year 2025; and Business process improvements. BRS requests...

On July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific per- and polyfluoroalkyl substances (PFAS). Canada’s “Guidance manual for responding to the: Notice with respect to certain per- and polyfluoroalkyl substances (PFAS)” (Guidance Manual) states that the purpose of the notice is to collect information on certain PFAS substances, either alone, in...

The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on July 18, 2024, that it selected 13 small businesses to develop innovative biobased products and biomass processing technologies. The companies, located across ten states, have been selected to receive up to $206,500 each for this Phase I Small Business Innovative Research (SBIR) award. According to BETO, of the 13 awards, six are first-time awardees, four are located in Historically Underutilized Business...

On July 15, 2024, the U.S. Environmental Protection Agency announced it is updating its process when it assesses the potential for exposure to pesticide drift when it reviews new active ingredient pesticide registrations or makes decisions on new use directions for existing pesticide registrations. EPA states it will review potential exposure to drift earlier in the review process. Historically, EPA has only conducted a chemical-specific assessment of the potential for people to be exposed to...

The Senate Committee on Environment and Public Works will hold a hearing on July 31, 2024, on “Understanding the Potential Environmental Impacts of the Chemical 6PPD.” The scheduled witnesses include: Katrina Lassiter, Program Manager, Hazardous Waste and Toxics Reduction Program, Washington State Department of Ecology (WDOE); Tracey Norberg, Executive Vice President and General Counsel, U.S. Tire Manufacturers Association (USTMA); and David B. Fischer, MPH, Counsel, Keller and Heckman LLP....

The standard of judicial review for most critical TSCA determinations under section 19 is "substantial evidence in the record taken as a whole". This is a tough standard, considerably more rigorous than the Administrative Procedure Act (APA) standard under section 706, where agency action will be set aside if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." The recent Loper Bright decision overturning Chevron has invited much...

The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office’s (BETO’s) Feedstock-Conversion Interface Consortium (FCIC) intends to issue in September 2024 an Industrial Partnership Call (IPC) to allow collaboration between industry stakeholders and FCIC researchers. According to BETO, research areas may include biomass supply, handling, transport, storage, preprocessing, and initial chemical conversion. To maximize the likelihood of near-term impact for industrial partners, BETO...

On July 2, 2024, the California Department of Pesticide Regulation (DPR) announced the release of modifications to its proposed pesticide application notification regulation. DPR states this regulation will support the statewide implementation of what it describes to be a “first-of-its-kind” system that would provide information to the public in advance regarding the planned applications of “restricted material pesticides” used in agriculture. DPR initially proposed the regulation on...

The European Commission (EC) launched a call on July 5, 2024, for applications for members of the new Technology Council for Advanced Materials. According to the Directorate General (DG) for Internal Market, Industry, Entrepreneurship and SMEs, “this high-level group will coordinate efforts to meet future needs for advanced materials in Europe, and is key to building a single advanced materials ecosystem.” The EC’s February 2024 Communication on Advanced Materials for Industrial Leadership...

Register now to join Bergeson & Campbell, P.C. (B&C®) for “Determining PFAS Content in Your Supply Chain and Expanding Data Collection Practice,” a complimentary webinar covering the basics of the U.S. Environmental Protection Agency’s (EPA) reporting rule for per- and polyfluoroalkyl substances (PFAS). With Chemical Data Reporting (CDR) wrapping up this fall, companies still have time to gather the necessary information regarding PFAS to begin reporting as early as this November....

The July 13, 2024, Canada Gazette will include a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Updated Draft Report defines PFAS as “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any [hydrogen, chlorine, bromine, or iodine...

As part of its efforts to strengthen public engagement in the federal regulatory process, the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) announced on July 10, 2024, that it will offer training sessions on effective public participation in the public comment process. 89 Fed. Reg. 56777. OIRA states that notice-and-comment rulemaking generally affords any interested individual or organization the opportunity to provide written input on the...

On July 10, 2024, the Internal Revenue Service (IRS) announced that it issued frequently asked questions (FAQ) in Fact Sheet 2024-25 related to which entities must apply for registration for the Clean Fuel Production Credit. As reported in our June 10, 2024, blog item, the Inflation Reduction Act allows a credit for the production of clean transportation fuels beginning on January 1, 2025. To claim a Clean Fuel Production Credit, the taxpayer must be registered as a producer of clean fuel at the...

On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane (1,1,2-TCA) issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). The court states that “EPA’s...

On July 5, 2024, the U.S. Department of Agriculture (USDA) released its spring 2024 Unified Agenda, which includes the following items regarding biobased products and biotechnology: Higher Blends Infrastructure Incentive Program: The Higher Blends Infrastructure Program is designed to increase the sales and use of higher blends of ethanol and biodiesel by expanding the infrastructure for renewable fuels derived from U.S. agricultural products. The Rural Business-Cooperative Service (RBCS)...

The House Committee on Oversight and Accountability will hold a full committee hearing on July 10, 2024, on “Oversight of the U.S. Environmental Protection Agency.” According to the Committee’s July 3, 2024, press release, “[t]he hearing will conduct oversight and gather information from U.S. Environmental Protection Agency (EPA) Administrator Michael Regan on the Biden Administration’s push of excessive environmental regulations and abuse of environmental protection authorities.”...

On June 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: Plants modified for altered product quality: CoverCress, two pennycresses; Hjelle Advisors, rice; and Toolgen, soybean; Plant modified for increased yield: Inari, two soybeans; Plant modified...

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is hosting the fully virtual 2024 Chemical Security Seminars on July 11 and 18, 2024, from 10:00 a.m. - 3:00 p.m. (EDT). The sessions will cover a range of topics related to the security of dangerous chemicals. The preliminary agenda includes: State of Chemical Security (Kelly Murray, Associate Director, CISA Chemical Security); Transnational Threats Impacting Chemical Security (Robert...

As reported in our July 27, 2023, memorandum, in July 2023, the U.S. Environmental Protection Agency (EPA) proposed an expansion of the Safer Choice and Design for the Environment (DfE) programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding,...

The U.S. Department of Agriculture (USDA) seeks public input on procedures for the quantification, reporting, and verification of the effect of climate-smart farming practices on the greenhouse gas (GHG) net emissions estimates associated with the production of domestic (i.e., grown in the United States) agricultural commodities used as biofuel feedstocks. 89 Fed. Reg. 53585. According to USDA’ s June 27, 2024, notice, agricultural management practices that mitigate GHG emissions and/or...

On July 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “Celebrating 20 Years of the Nanotechnology Research Center: Highlights from Engineering Controls and Personal Protective Equipment,” part of a series commemorating the 20th anniversary of the Nanotechnology Research Center (NTRC). The item notes that NIOSH researchers “have conducted laboratory and field research to develop and implement science-based national...

The National Nanotechnology Initiative (NNI) and the National Nanotechnology Coordination Office (NNCO) are convening a July 24, 2024, workshop, “Responsible Development, Social Science, and the National Nanotechnology Initiative: A Workshop to Explore Past and Future Intersections.” According to NNI, the workshop will bring together federal experts in nanotechnology with social scientists with expertise on specific tools and frameworks relevant to the responsible development of emerging...

On June 25, 2024, the U.S. Environmental Protection Agency (EPA) announced the issuance of a final cancellation order for Corteva’s chlorpyrifos product “Dursban 50W in Water Soluble Packets” and three Gharda chlorpyrifos products, and an amendment to the existing stocks provisions for two Liberty and three Winfield chlorpyrifos end-use products. EPA also states that it has updated its frequently asked questions about chlorpyrifos. In a final rule issued in August 2021, EPA revoked all...

The White House Office of Science and Technology Policy (OSTP) published a fact sheet on June 25, 2024, on the Biden-⁠Harris Administration’s actions to advance American biotechnology and biomanufacturing. According to the fact sheet, on June 25, 2024, the White House, members of the National Bioeconomy Board, and the U.S. Departments of Energy (DOE), Defense (DOD), and Agriculture (USDA) convened major biotechnology and biomanufacturing companies, nonprofits, and other stakeholders to...

The Minnesota Department of Health (MDH) recently noted that Health Risk Assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to per- and polyfluoroalkyl substances (PFAS): “A revised and improved toxicokinetic model to simulate serum concentrations of bioaccumulative PFAS”: According to MDH, the publication “presents an updated method to determine how PFAS accumulates in human bodies from birth through childhood.” “Per-...

Bergeson & Campbell, P.C.’s (B&C®) June 18, 2024, webinar, "There Is More to TSCA Reporting Than CDR: TSCA Sections 8(a), (c), (d), and (e)," is now available for on-demand viewing. During this one-hour webinar Dave Turk, Supervisor for the Toxics Release Inventory (TRI) Regulatory and Policy Branch, U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Stephanie Griffin, Acting Supervisor of the Data Collection Branch, EPA OPPT; Richard E....

During the June 26, 2024, “TSCA Reform -- Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute, (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA) provided the keynote address. During her remarks, Freedhoff announced four new initiatives in...

The U.S. Department of Agriculture’s (USDA) Animal and Health Inspection Service (APHIS) announced on June 25, 2024, that it will soon publish a request for information (RFI) in the Federal Register, beginning a 60-day public comment period. According to APHIS, the RFI will explore options to reduce the regulatory burden for modified microbes. APHIS states that it developed the RFI in response to stakeholder requests. Specifically, APHIS will request comments to help identify: Potential...

The European Chemicals Agency (ECHA) is evaluating the function of the European Union (EU) Observatory for Nanomaterials (EUON). As part of its evaluation, ECHA is conducting a survey to collect responses from EUON website visitors and stakeholders. The survey includes questions concerning evaluation criteria such as use, effectiveness, coherence, EU-added value, and utility. The survey notes that under an ongoing legislative proposal, the European Commission (EC) foresees setting up a common...

The Minnesota Pollution Control Agency (MPCA) will hold two public webinars in July to provide updates and answer questions on Minnesota’s per- and polyfluoroalkyl substances (PFAS) in products law (Amara’s Law), which takes effect in stages between 2025 and 2032: Progress on rule development, July 18, 2024, 10:00 a.m. - 11:30 a.m. (CDT): Join MPCA staff for a presentation on preliminary rule writing for the PFAS in products reporting, fees, and currently unavoidable use (CUU) rules....

On June 12, 2024, the European Chemicals Agency (ECHA) announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials, stating: Why further research is needed: Critical test methods to address the human and environmental hazard and risk assessment of nanomaterials are still missing....