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NANORIGO, RiskGONE, and Gov4Nano, in collaboration with the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN), will hold a conference in January 2023 on “Future-proof Approaches for Risk Governance.” According to NANORIGO’s September 14, 2022, press announcement, the conference is intended to help shape international approaches to addressing future challenges in risk governance of nano- and advanced materials....

October 26, 202212:00 p.m. - 1:00 p.m. (EDT)Register Now  The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to...

On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023. Title X of the...

Download transcript. This week I sat down with James Cox, M.S., Senior Scientist with B&C. James is an exceptional biologist with significant experience assessing the risk of industrial chemicals. Before joining B&C, James served in a variety of leadership positions in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevent and Toxics, one of which was Chair of the Risk Assessment Technical Team, which provided recommendations to inform EPA’s policy...

On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...

October 11, 202212:00 p.m. - 1:00 p.m. (EDT) REGISTER NOW Environmental, Social, and Governance (ESG) performance is more than an aspiration, and realizing it in real time is not easy. A well-designed ESG strategy can achieve meaningful improvements in corporate performance and provide real value to stakeholders through specific commitments to corporate responsibility. Any such approach, however, must be measurable, transparent, and accountable. Join experts from FTI Consulting, Christine...

The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, it released its draft ecological risk assessment for dicamba for a 60-day public review. 87 Fed. Reg. 50854. The 287-page assessment examines the potential ecological risks associated with currently registered uses of dicamba on non-target, non-listed species. Risks to federally listed threatened and endangered species are not evaluated in the assessment. EPA is reevaluating the risks of dicamba...

The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA....

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and...

On July 5, 2022, the U.S. Environmental Protection Agency (EPA) issued a final rule amending the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align with revisions that were made to the Occupational Safety and Health Administration (OSHA) Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker...

The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach...

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier states that in many cases, novel materials offer solutions to environmental...

On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on...

The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. The following presentations from the conference have been posted online....

The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better...

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI). Proposed Rule Stage Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management under TSCA (2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in the...

Wednesday, August 3, 202212:00 p.m. - 1:00 p.m. (EDT)Register Today The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace...

On June 29, 2022, 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 -- Six Years Later.” This virtual conference marked the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics,...

On June 28, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Models to Characterize Exposures to Manufactured Nanomaterials in OECD” by Vladimir Murashov, Ph.D., Senior Scientist in the Office of the Director, National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., Director of NIOSH and Administrator of the World Trade Center Health Program in the U.S. Department of Health and Human Services. The authors...

On June 29, 2022, 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 -- Six Years Later.” This virtual conference marked the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics,...

The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions that is caused by submitters...

On June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” The Committee’s only witness was Michal Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Freedhoff’s written testimony...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 17, 2022, that it is looking for topics that could be addressed in its upcoming studies. EUON conducts up to three studies annually to address knowledge gaps on nanomaterials. EUON is looking for study topics that address: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues...

On June 17, 2022, Canada published its draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA) for a 60-day public comment period. The plain language summary states that the framework describes how scientists at Environment and Climate Change Canada (ECCC) and Health Canada (HC) conduct risk assessments on nanomaterials. The draft risk assessment framework outlines approaches and considerations for...

By  Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research...

On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal...

Download transcript. This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin is an internationally recognized expert on hazard communication, risk assessment, the regulation of food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Karin’s expertise in hazard communication and GHS was recently recognized as Karin was elected to the Board of...

The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on May 17, 2022, on the fiscal year (FY) 2023 budget for the U.S. Environmental Protection Agency (EPA), and the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a separate hearing on May 18, 2022. EPA Administrator Michael S. Regan was the only witness at each hearing. The hearings included questions about EPA’s implementation of the...

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and...

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and...

By  Lynn L. Bergeson On April 20-21, 2022, EPA held a virtual public meeting to provide an overview of the TSCA New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a...

The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research...

On April 29, 2022, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing on President Biden’s fiscal year (FY) 2023 budget request for the U.S. Environmental Protection Agency (EPA). In his written testimony, EPA Administrator Michael S. Regan notes that “[c]hemicals and toxic substances are ubiquitous in our everyday lives and are often released into the environment from their manufacture, processing use, or disposal.”...

On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the European Union (EU) chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy)....

Wednesday, May 18, 202212:00 p.m. - 1:00 p.m. (EDT)Register Today A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a...

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable...

The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and...

On April 20, 2022, Germany’s Federal Institute for Risk Assessment (BfR) announced that the fourth joint symposium on nanotechnology will be held May 30-31, 2022. During the symposium, experts will present their findings on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the effects of nanomaterials on the body, and future-oriented assessment approaches. BfR notes that with nanotechnology, consumer protection is expanding into...

On May 4-5, 2022, the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors (BOSC) Executive Committee will meet to review the Office of Research and Development’s (ORD) six Strategic Research Action Plans (StRAP) for fiscal years (FY) 2023-2026. The meetings are open to the public. 87 Fed. Reg. 23861. BOSC will consider comments on the draft StRAPs that are submitted by May 3, 2022. Requests for the draft agenda or making a presentation at the meeting...

On April 20-21, 2022, the U.S. Environmental Protection Agency (EPA) held a virtual public meeting to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and...

The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include: Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon...

The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include: Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon...

By Lynn L. Bergeson  The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states that EPA has significant responsibilities under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and addressing unreasonable...