Blogs

By Lynn L. Bergeson and Carla N. Hutton   On July 27, 2023, the Organization for Economic Cooperation and Development (OECD) published a new document in its Series on Harmonization of Regulatory Oversight in Biotechnology, Safety Assessment of Transgenic Organisms in the Environment, Volume 10: OECD Consensus Document on Environmental Considerations for the Release of Transgenic Plants. The document addresses environmental risk/safety assessment at a broader level than previous consensus...

On August 15, 2023, the U.S. Environmental Protection Agency (EPA) will hold a webinar on its proposed rule to protect workers from exposure to carbon tetrachloride (CTC).  EPA published the proposed rule on July 28, 2023. 88 Fed. Reg. 49180. EPA states that if issued in final, “the rule would require a workplace chemical protection program with strict exposure limits for essentially the entire domestic production volume of CTC, workplace controls for laboratory use of CTC, and a ban...

By Lynn L. Bergeson and Carla N. Hutton On July 19, 2023, the U.S. Environmental Protection Agency (EPA) extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. 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...

On June 26, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The Guidance covers the main elements of safety assessment, i.e., general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6). SCCS states...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on July 17, 2023, that it will host a Bioenergy Cybersecurity Workshop, a virtual event organized by Sandia National Laboratories on September 11, 2023, to identify cybersecurity risks in biofuel and bioproduct manufacturing, and develop an approach to address these risks. According to BETO, the workshop will raise awareness of the importance of cybersecurity in...

On July 31, 2023, the U.S. Environmental Protection Agency (EPA) announced that it provided more than $1.3 million in funding to a team of researchers from the University of Wisconsin-Madison to develop nanosensor technology that can detect, monitor, and degrade commonly used pesticides found in water that can harm human health. According to EPA, using funding from the grant, researchers will develop an integrated, portable, sensor-controlled water treatment technology that itself...

On July 31, 2023, the U.S. Environmental Protection Agency (EPA) announced that it provided more than $1.3 million in funding to a team of researchers from the University of Wisconsin-Madison to develop nanosensor technology that can detect, monitor, and degrade commonly used pesticides found in water that can harm human health. According to EPA, using funding from the grant, researchers will develop an integrated, portable, sensor-controlled water treatment technology that itself...

On July 25, 2023, 12 members of the House sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan urging EPA “to conduct a rigorous, comprehensive, and transparent assessment of the risks of [per- and polyfluoroalkyl substances (PFAS)] in fluorinated containers.” The letter states that EPA is mandated by the Toxic Substances Control Act (TSCA) to address the risks of new PFAS and significant new uses of existing PFAS. According to the letter, the...

By Lynn L. Bergeson and Carla N. Hutton   On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities: Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to...

On July 25, 2023, the U.S. Environmental Protection Agency (EPA) issued a final rule regarding the reporting and recordkeeping requirements for asbestos under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 47782. EPA states in its July 6, 2023, press release that under the reporting rule, manufacturers (including importers) or processors of asbestos between 2019 and 2022 with annual sales above $500,000 in any of those years are required to report exposure-related information,...

By Lynn L. Bergeson and Carla N. Hutton   On July 24, 2023, Senators Amy Klobuchar (D-MN), Joni Ernst (R-IA), Debbie Stabenow (D-MI), and Pete Ricketts (R-NE) introduced the Biomanufacturing and Jobs Act to strengthen the U.S. Department of Agriculture’s (USDA) BioPreferred program. According to Klobuchar’s July 24, 2023, press release, the bill would: Strengthen markets for farmers while also supporting well-paying manufacturing jobs; Allow the Secretary of Agriculture to set...

On July 20, 2023, the Senate voted 53 to 46 to confirm David Uhlmann to be Assistant Administrator for the Office of Enforcement and Compliance Assurance (OECA) at the U.S. Environmental Protection Agency (EPA). As reported in our September 17, 2021, memorandum, Uhlmann was the Director of the Environmental Policy and Law Program at the University of Michigan Law School. Prior to academia, Uhlmann spent 17 years as a federal prosecutor, including seven years with the...

On September 20, 2023, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on Test Guideline No. 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement. The webinar will present the method to determine the hydrophobicity index (Hy) of nanomaterials, through an affinity measurement, described in the OECD Test Guideline (TG) No. 126. According to OECD, webinar attendees will be able to learn the use and limitation...

On July 19, 2023, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) posted a blog item entitled “Making Voices Heard in the Regulatory Process,” announcing the release of “guidance detailing new steps that Federal agencies should take to make it easier for interested members of the public to voice their views in the regulatory process.” According to OIRA, new directions to federal agencies in the guidance include: OIRA’s guidance...

The U.S. Environmental Protection Agency (EPA) announced on July 19, 2023, that it is extending the public comment period for its proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) to ensure chemicals made from plastic waste-derived feedstocks are free from certain contaminants before they can be used to make transportation fuels. The SNURs would require companies to notify EPA before manufacturing or processing 18 chemicals made from plastic waste-derived...

Bergeson & Campbell, P.C. (B&C®) affilaite The Acta Group (Acta®) and EPPA’s July 11, 2023, webinar, “Preparing a PFAS Game Plan in the U.S., the UK, and the EU,” is now available for on-demand viewing. During this one-hour webinar, Meglena Mihova, Managing Partner of EPPA, a Brussels-based regulatory and public affairs consultancy; Richard E. Engler, Ph.D., Director of Chemistry, Acta; and Lynn L. Bergeson, President, Acta, discussed bans, restrictions,...

The U.S. Environmental Protection Agency (EPA) held a webinar on July 18, 2023, on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). EPA has added a second webinar date, July 20, 2023, at 2:00 p.m. (EDT). 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...

On July 19, 2023, the U.S. Environmental Protection Agency (EPA) will publish a Federal Register notice extending the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 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”...

The Internal Revenue Service (IRS) announced on July 17, 2023, that it received a petition requesting that methyl ethyl ketoxime (MEKO) be added to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 45454. The petitioner is AdvanSix Inc., an exporter of MEKO. The notice includes the following description of the petition: According to the petition, MEKO is a clear liquid and a high-efficiency, anti-skinning agent that is used for...

On June 22, 2023, the White House Office of Science and Technology Policy (OSTP) published its Scientific Integrity Policy, which was adopted on May 17, 2023. The purpose of the policy “is to provide instruction and guidance to enhance and promote a continuing culture of scientific integrity” at OSTP. The policy aims to ensure the integrity of all aspects of OSTP scientific activities and establishes the expectations and procedures required to maintain scientific integrity at...

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On June 29, 2023, 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 — Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and...

The Organization for Economic Cooperation and Development (OECD) announced on July 4, 2023, that it published a number of new, updated, and corrected Test Guidelines (TG), including the following for nanomaterials: On July 4, 2023, OECD also released a corrected version of its Report on the WNT Workshop how to prepare the Test Guidelines Programme for emerging technologies. The Working Party of the National Coordinators of the TG Program (WNT) held a workshop in December 2022 on...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants: InnerPlant modified two soybean plants and one tomato plant to...

On June 16, 2023, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a new report providing an overview of new approach methods (NAM) in human health risk assessment of chemicals and calling on the U.S. Environmental Protection Agency (EPA) to develop a framework for evaluating and building trust in NAMs. NASEM states that some pollutants, such as lead, benzene, and ozone, are well studied, enabling EPA to characterize their hazards and risks...

Switzerland’s Federal Office of Public Health (FOPH) has updated its precautionary matrix for synthetic nanomaterials, which is a method for assessing the nano-specific health and environmental risks of nanoproducts. According to FOPH, the precautionary matrix enables the structured assessment of the “nano-specific need for precautions” when handling synthetic nanomaterials. The precautionary matrix is designed “to help industry and trade comply with their due diligence and their...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) hosted its 2023 Project Peer Review on April 3-7, 2023. During the event, more than 280 projects in BETO’s research, development, and demonstration portfolios presented their progress and accomplishments to the public and were reviewed by more than 50 external subject-matter experts from industry, academia, and federal agencies. The 2023 Project Peer Review...

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...