Blogs

On July 7, 2023, Earthjustice, on behalf of its clients, announced that it notified the U.S. Environmental Protection Agency (EPA) of its intent to sue for missing the statutory deadlines under the Toxic Substances Control Act (TSCA) for EPA to evaluate the risks to public health posed by 22 toxic chemicals. Earthjustice states that until EPA completes the overdue risk evaluations, “some of the most dangerous and widely used chemicals on the market will remain...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7,...

By Lynn L. Bergeson and Carla N. Hutton   On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted its inaugural Biomanufacturing Policy Summit in Brussels, “marking the first major milestone from its newly established Biomanufacturing Platform.” The Summit captured priorities of 80 industry leaders,...

By Lynn L. Bergeson and Carla N. Hutton   The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA states that the webinar will be useful for anyone looking...

The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. Following the mandate from the EC, the scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered to be safe in light of the exposure identified and in light of the classification of titanium dioxide...

By Lynn L. Bergeson and Carla N. Hutton   On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture announced on June 26, 2023, that it plans to invest up to $500 million from President Biden’s Inflation Reduction Act to increase the availability of domestic biofuels and “give Americans additional cleaner fuel options at the pump.” USDA notes that in December 2022, it made available $50 million in Inflation Reduction Act funding to expand the use and availability of higher-blend...

On June 20, 2023, the U.S. Environmental Protection Agency (EPA) announced that it is seeking input from stakeholders on ways to make bilingual pesticide labeling accessible to farmworkers and to implement a plan to ensure that farmworkers have access to the bilingual pesticide labeling by December 2025, as required by the Pesticide Registration Improvement Act of 2022 (PRIA 5). 88 Fed. Reg. 39845. PRIA 5 requires EPA to begin to seek stakeholder input on ways to make...

10:00 a.m. – 11:00 a.m. (EDT)4:00 p.m. – 5:00 p.m. (CEST) REGISTER NOW Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of these global legal developments and take steps now to minimize legal, regulatory, and commercial risk. In the United States and globally, the number...

By Lynn L. Bergeson and Carla N. Hutton   On June 21, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under the Renewable Fuel Standard (RFS) program that will establish the biofuel volume requirements from 2023 to 2025. According to EPA, the final rule “builds on the RFS program’s progress over the previous two years and reflects the Biden-Harris Administration’s commitment to strengthen the nation’s energy independence, advance...

On June 22, 2023, the U.S. Environmental Protection Agency (EPA) called for public nominations of scientific and technical experts to review the “2023 White Paper on the Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2.” 88 Fed. Reg. 40819. EPA states that it will release the white paper for public review and comment in late July 2023 and subsequently submit it for letter peer review. EPA currently anticipates selecting approximately ten...

On June 23, 2023, the U.S. Environmental Protection Agency (EPA) updated the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 88 Fed. Reg. 41035. Specifically, EPA updated the regulations to identify nine per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) enacted on December 20,...

On June 22, 2023, the U.S. Environmental Protection Agency (EPA) announced that the 2024 submission period for the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule is from June 1, 2024, to September 30, 2024. 88 Fed. Reg. 40816. The CDR rule requires manufacturers (including importers) of chemical substances on the TSCA Inventory above an applicable regulatory threshold to report to EPA, every four years, information concerning the manufacturing,...

The Senate Committee on Environment and Public Works announced on June 22, 2023, that Senators Tom Carper (D-DE), Chair of the Committee, and Shelley Moore Capito (R-WV), Ranking Member of the Committee, have released draft per- and polyfluoroalkyl substances (PFAS) legislation for stakeholder comment. According to the press release, the bipartisan package seeks to improve the mitigation and remediation of PFAS contamination. The Committee seeks stakeholder comments on the...

The Maine Department of Environmental Protection (MDEP) has updated its frequently asked questions (FAQ) regarding per- and polyfluoroalkyl substances (PFAS) in products to reflect LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). MDEP states that the Act has extended the implementation date for product reporting, requiring manufacturers of products with intentionally added PFAS to report the intentionally added...

On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of draft guidance for the evaluation of products for claims against viruses. This new guidance provides the framework for registrants who seek to make virucidal claims for antimicrobial products. This draft guidance reiterates recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims...

The U.S. Environmental Protection Agency (EPA) announced on June 15, 2023, that it will issue proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals made from plastic waste-derived feedstocks. According to EPA, the proposed SNURs would require notification to and review by EPA before these fuels could be made using plastic waste-derived feedstocks that contain impurities like per- and polyfluoroalkyl substances (PFAS), heavy metals, dioxins,...

The U.S. Environmental Protection Agency (EPA) announced on June 14, 2023, that it is accepting public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with its review of the 2023 draft supplement to the 1,4-dioxane risk evaluation under the Toxic Substances Control Act (TSCA). EPA states that after it published the final risk evaluation for 1,4-dioxane in December 2020, it determined a supplement was...

Under H.F. 2310, signed into law by Governor Tim Walz (D) as part of the One Minnesota Budget on May 24, 2023, on or before January 1, 2026, a manufacturer of a product sold, offered for sale, or distributed in Minnesota that contains intentionally added per- and polyfluoroalkyl substances (PFAS) must submit to the Minnesota Pollution Control Agency (MPCA) information that includes: A person may not sell, offer for sale, or distribute for sale in Minnesota a product...

8:00 a.m. – 5:30 p.m. EDTJune 29, 2023 REGISTER NOW The full program, including session details and confirmed speakers for the 7th annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform — Seven Years Later,” is detailed below. This timely and essential day-long virtual conference will provide updates on risk evaluation, risk management, new chemical review, per- and polyfluoroalkyl substances (PFAS), and more. Bergeson & Campbell, P.C. (B&C®), the...

According to NNI, the roundtable is a critical part of the Nano4EARTH National Nanotechnology Challenge, which aims to leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies and industries that address climate change. Nano4EARTH focuses on facilitating opportunities for members of the nanotechnology community to convene, collaborate, and share resources. Nano4EARTH also strives to provide mechanisms that support technology development and...

On May 18, 2023, Senator Alex Padilla (D-CA) and Representative Zoe Lofgren (D-CA) introduced the Supercomputing for Safer Chemicals (SUPERSAFE) Act (S. 1685, H.R. 3457). According to Padilla’s May 18, 2023, press release, the legislation would establish a SUPERSAFE Consortium led by the U.S. Environmental Protection Agency (EPA) “to identify chemicals that are safe to use in commerce through science-backed decision making.” The press release states that the bill would direct the use...

On June 8, 2023, the California Department of Pesticide Regulation (DPR) issued Notice 2023-07: Pesticide Registration Program Annual Processing Timelines. Under Notice 2023-07, DPR sets forth its annual report summarizing the past five years of registration and post-registration activities. This includes the number of pesticide product registration and amendment submissions received and processed, and average number of days to complete different types of registration submissions are also...

The Senate Environment and Public Works Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight will hold a hearing on June 15, 2023, on “Impacts of Plastic Production and Disposal on Environmental Justice Communities.” Originally scheduled for April 27, 2023, witnesses will include: On May 2, 2023, EPA announced the release of a Draft National Strategy to Prevent Plastic Pollution. EPA identified three key objectives for the...

POSTED IN INTERNATIONAL, LEGAL/REGULATORY ISSUES, OECD The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on...

Governor Janet Mills (D) has signed LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). Passed by the House on June 1, 2023, and the Senate on June 6, 2023, the bill postpones the January 1, 2023, reporting requirement for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). As reported in our February 17, 2023, memorandum, the Maine Department of Environmental...

 On June 6, 2023, the Maine Senate passed LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). Passed by the House on June 1, 2023, the bill would postpone the January 1, 2023, reporting requirement for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). As reported in our February 17, 2023, memorandum, the Maine Department of Environmental Protection (MDEP) issued a...

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared...

The European Union (EU) Observatory for Nanomaterials (EUON) has posted two Nanopinions:...

On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including per- and...

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal...

On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced a new effort closing out notification actions for minor pesticide label or product formulation changes in an effort to reduce the backlog, which, EPA states, will allow it to focus its limited resources on addressing higher priority actions. EPA announced it has closed out approximately 2,000 antimicrobial actions submitted to EPA prior to October 1, 2022. EPA states that the notification actions do not impact...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 30, 2023, that the Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on June 14, 2023, on “Perspectives on Engineered Catalyst Design and Forming.” ChemCatBio is a consortium of eight DOE national laboratories overseen by BETO. According to BETO, the performance evaluation, and ultimate commercial adoption, of...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy (DOE) announced on May 24, 2023, the launch of the Clean Fuels & Products ShotTM, a new initiative that aims to reduce significantly greenhouse gas emissions (GHG) from carbon-based fuels and products. DOE notes that this is its seventh DOE Energy Earthshot, which focuses on reducing carbon emissions from the fuel and chemical industry through alternative, more sustainable sources of carbon...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that additional FIFRA Tutor® regulatory training courses are now available at www.FIFRAtutor.com. The one-hour F105 — Due Diligence and Transferring FIFRA Registrations and/or Data module and two-hour F208 — Data Citation, Data Compensation, and Data Sharing module join six existing FIFRA Tutor courses providing expert, essential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)...

 By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) has launched a new, comprehensive web page dedicated to one of its priority subprograms, Renewable Carbon Resources (RCR), which helps develop RCR technologies and creates strategies for bioenergy and bioproducts production. In its May 19, 2023, announcement, BETO states that RCR supports applied research and pilot-scale projects for the production,...

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the European Commission’s (EC) revised Recommendation on the definition of nanomaterial, published in June 2022, “is too restrictive and could lead to a regression in the protection of public health and the environment.” ANSES “is therefore urging the French authorities to take a more inclusive definition into account and work...

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 15, 2023, that a new workflow developed by researchers at the Agile BioFoundry (ABF), a BETO-funded consortium of national laboratories and Agilent Research Laboratories (Agilent) addresses the need for faster analytical tools. According to BETO, the workflow “combines state-of-the-art analytical technologies with a machine learning-based...

On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process,...

By Lynn L. Bergeson and Carla N. Hutton   On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg...

The White House Office of Science and Technology Policy (OSTP) has extended the comment period for its April 5, 2023, request for information (RFI) seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 33174. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is...

On May 23, 2023, U.S. Environmental Protection Agency (EPA) Region 9 announced a settlement with Watts Regulator Company for alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) related to the sale or distribution of misbranded water filtration devices and importation of pesticides into the United States. Watts, which is headquartered in Massachusetts, imported devices through a port of entry within EPA Region 9. The specific alleged violations...

 On May 22, 2023, Public Employees for Environmental Responsibility (PEER) and Center for Environmental Health (CEH) submitted “extensive comments to the U.S. Environmental Protection Agency (EPA) demonstrating serious health risks from Inhance Technologies’ unlawful manufacture of per-and polyfluoroalkyl substances (PFAS) during its fluorination of hundreds of millions of plastic containers.” According to PEER’s press release, the comments call on EPA “to deny the company’s...

Bergeson & Campbell, P.C.’s (B&C®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed...

As reported in our May 10, 2023, blog item, the National Nanotechnology Initiative (NNI) is holding two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of plastics over their full life cycles,”...

On May 17, 2023, the U.S. Environmental Protection Agency (EPA) announced it released, and is seeking public comment on, draft guidance that claims to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. When the guidance is issued in final, EPA states that it will fulfill the requirements outlined in the Pesticide Registration Improvement Act of...

On April 20, 2023, the Public Employees for Environmental Responsibility (PEER) issued a press release announcing that, together with the Center for Environmental Health (CEH), it sent a letter to the U.S. Environmental Protection Agency (EPA) asking EPA to “fix” the public comment process for 18 significant new use notices (SNUN) for per- and polyfluoroalkyl substances (PFAS) created by Inhance Technologies in the fluorination of millions of plastic containers. PEER...