July 12, 2023
TSCA at Seven: As Reasonably Foreseen, ELI and B&C Conclude Another Riveting Conference
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 where...
July 11, 2023
OECD Publishes New, Corrected TGs for Nanomaterials and Workshop Report on How to Prepare TGs for Emerging Technologies
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: TG No. 126: Determination of the Hydrophobicity Index of Nanomaterials through an Affinity Measurement: This new TG describes a method to determine the hydrophobicity index (Hy) of nanomaterials, through an affinity measurement. OECD states that hydrophobicity is defined as...
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...
July 10, 2023
NASEM Report Recommends that EPA Develop Framework for Evaluating NAMs for Toxicity Testing
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 to...
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...
July 7, 2023
Earthjustice Files Notice of Intent to Sue EPA for Missing TSCA Risk Evaluation Deadlines
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 unregulated under [TSCA].”...
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, 2023. EPA states that the...
July 6, 2023
EuropaBio Offers Recommendations on Biomanufacturing
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,...
July 5, 2023
OECD Working Party on the Harmonization of Regulatory Oversight in Biotechnology Met in April 2023
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 for...
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 as carcinogenic category 2...
July 3, 2023
OSTP Announces New Action Plan to Bolster, Expand, and Diversify the Biotechnology and Biomanufactur
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...
June 30, 2023
Biden Administration Announces Funding for Homegrown Biofuels under Inflation Reduction Act
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 biofuels through...
June 29, 2023
EPA Requests Comments for Implementation of PRIA 5 Bilingual Labeling Requirements for Agricultural Pesticides
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 bilingual...
June 28, 2023
Registration Now Open for “Preparing a PFAS Game Plan in the U.S., the UK, and the EU” Webinar
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 of bans,...
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...
June 27, 2023
EPA Requests Nominations for Experts to Review White Paper to Be Used in the Risk Evaluation for Asbestos Part 2 under TSCA
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 to 15...
June 26, 2023
EPA Implements Statutory Addition of Certain PFAS to TRI Beginning with Reporting Year 2023
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,...