Blogs

The National Nanotechnology Coordination Office (NNCO) is organizing a series of National Nanotechnology Initiative (NNI) webinars on nanometrology, metrological challenges, and recent advances in three topical areas: food, agriculture, and the environment; nanoscale medical and pharmaceutical products; and nanoparticles in electronics. Registration is open for the fifth webinar in the series, “Nanometrology for Continuous and Automated Manufacturing.” The October 4, 2024, webinar will...

On September 3, 2024, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances: Comments and requests for a public hearing are due November 4, 2024. More information on the Superfund excise tax on chemicals is available in our April 4, 2023, memorandum, “IRS Proposes Regulations Regarding Superfund Tax on Chemicals,” our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need...

The U.S. Securities and Exchange Commission (SEC) announced on September 10, 2024, that it charged Keurig Dr Pepper Inc. (Keurig®) with making inaccurate statements regarding the recyclability of its K-Cup® single-use beverage pods. To settle SEC’s charges, Keurig agreed to pay a $1.5 million civil penalty. SEC’s order states: Beginning in or around 2016, Keurig performed tests of its pods at various recycling facilities, in which Keurig tracked the progress of pods throughout the...

The Biotechnology Risk Assessment Grants (BRAG) program supports the development of new information that will assist federal regulatory agencies in making evidence-based decisions about the effects of genetically engineered organisms on the environment. BRAG is co-administered by the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS) and jointly funded by NIFA, ARS, and USDA’s Forest Service. NIFA announced on...

On August 20, 2024, the U.S. Department of Defense (DOD) announced seven additional awards to bioindustrial firms via the Distributed Bioindustrial Manufacturing Program (DBIMP), bringing the DBIMP to 13 awards to date totaling $23 million. The following companies will receive funding to produce business and technical plans that detail construction of domestic bioindustrial manufacturing production facilities: Successful projects that were selected under the competitive announcement can receive...

On September 10, 2024, the House Energy and Commerce Subcommittee on Health will hold a legislative hearing on “Evaluating FDA Human Foods and Tobacco Programs.” According to the Committee’s September 3, 2024, hearing announcement, the hearing will give members a chance to hear from the head of the Human Foods Program, as well as the head of the Tobacco Center, to learn how the U.S. Food and Drug Administration (FDA) is “helping adult smokers quit,...

The U.S. Department of Energy (DOE) announced on September 4, 2024, that its Bioenergy Technologies Office (BETO) is overseeing a call for industry partnerships to connect industry stakeholders with the capabilities of the Feedstock-Conversion Interface Consortium (FCIC). According to DOE, the funding opportunity will provide resources that allow partners to collaborate with FCIC researchers to address the cost and risk impacts of feedstock and process variability across the bioenergy and...

The U.S. Environmental Protection Agency is scheduled to publish a direct final rule on September 5, 2024, that will amend the Toxic Substances Control Act (TSCA) regulation with reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS) to make a “one-time modification” to change the data submission period from November 12, 2024, through May 8, 2025, to July 11, 2025, through January 11, 2026. For any reporter who is reporting exclusively as an article...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 19, 2024, on “A Safer Choice for Cleaning: Increasing Access to Products with Safer Ingredients.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, will host a webinar on how EPA’s Safer Choice program helps people find and have access to cleaning and other products made with safer ingredients and how the program works in partnership with a broad range of stakeholders to...

The U.S. Environmental Protection Agency (EPA) announced on August 29, 2024, that it is now accepting nominations for the 2025 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. According to EPA, its “efforts to speed the adoption of this revolutionary and diverse discipline have led to significant environmental benefits, innovation and a strengthened economy.” EPA...

The U.S. Environmental Protection Agency (EPA) will hold two virtual public meetings, on September 30 and October 1, 2024, to provide information regarding existing chemical pre-prioritization and prioritization activities under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 68894. EPA states in its August 28, 2024, notice that “[t]he purpose of prioritization is to designate a chemical substance as being either high priority for immediate further risk evaluation, or low priority, for...

On August 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: APHIS states that it found these modified plants were unlikely to pose an increased plant pest risk compared to other cultivated plants. As a result, they are not subject to regulation under...

As reported in our July 29, 2024, blog item, 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). On September 11, 2024, at 1:30 p.m. (EDT), Environment and Climate Change Canada (ECCC) will hold an information session in English on the survey. The session will be non-interactive and will...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based...

On August 20, 2024, the California Department of Pesticide Regulation (DPR) announced it will launch its electronic pesticide registration system, the California Pesticide Electronic Submission Tracking (CalPEST), on September 24, 2024. The launch of CalPEST will convert its paper-based pesticide registration process to a streamlined electronic system. According to DPR, it is conducting the final stages of testing and has identified areas for improvement in system functionality and security that...

As part of its quadrennial review of the National Nanotechnology Initiative (NNI), the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a virtual town hall on September 5, 2024, for stakeholders to share their thoughts on the future of nanotechnology in the United States. The overall objective of NASEM’s review is to identify opportunities and barriers to broadening access to nanotechnology research and development (R&D) infrastructure in the United States. As...

As reported in our August 7, 2024, blog item, 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. 89 Fed. Reg. 65633. FDA has posted a Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food (Discussion Paper)....

On August 18, 2024, Computational Toxicology published an article entitled “Development of chemical categories for per- and polyfluoroalkyl substances (PFAS) and the proof-of-concept approach to the identification of potential candidates for tiered toxicological testing and human health assessment.” Co-authored by members of the U.S. Environmental Protection Agency’s (EPA) Center for Computational Toxicology & Exposure (CCTE) and Office of Chemical Safety and Pollution Prevention...

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...

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...

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...

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...

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...

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...

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: The blog item states that “[c]ombustibility should...

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...

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:...

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: BRS requests feedback on discussion topics for the meeting. Suggestions on potential topics of interest are due...

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: As reported in our November 3, 2023, blog item, on November 2, 2023, the U.S. Environmental Protection Agency (EPA) granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) to address the use of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires....

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...

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...