By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second of its two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). The webinar, which will be held March 30, 2023, will give an in-depth look into the standardized risk assessment approach and present various case scenarios and a decision tree for identifying potential hazards and risks. The kickoff webinar, held in November 2022, provided a broad overview of the approach and answered stakeholder questions. A summary of the first webinar is available in our November 23, 2022, memorandum.
 
Under the Toxic Substances Control Act (TSCA), EPA reviews all new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment. As reported in our October 11, 2022, memorandum, EPA announced an innovative effort to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs have many electrical applications in batteries and uses as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, making them a vital part of clean energy sectors.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced outreach to describe how it evaluates engineering (i.e., environmental release and worker exposure) data for new chemical submissions and common causes of EPA having to reconduct risk assessments (i.e., “rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
The February 28, 2023, webinar is the third and final webinar in a series to increase the efficiency and transparency of EPA’s new chemical determinations. The first two webinars, held in July and October 2022, focused on common issues that cause EPA to rework risk assessments, clarifications of common misconceptions in EPA’s new chemical assessments, and other information related to TSCA Section 5 submissions. More information on these webinars is available on EPA’s website and in our July 28, 2022, and October 25, 2022, memoranda.

• Email This
• Print

Bergeson & Campbell, P.C.’s (B&C^®) January 31, 2023, webinar “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C discussed the U.S. Environmental Protection Agency’s (EPA) priorities, leadership, and operating environment in the new year. This includes a review of priorities and challenges that will shape updates that are expected to affect Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) implementation in 2023.

Additional Resources:

• Forecast for U.S. Federal and International Chemical Regulatory Policy 2023, a richly detailed 110-page document offering our seasoned team’s best-informed judgment on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the new year.
• All Things Chemical^® podcast episodes:
  • “What to Expect in Chemicals Policy and Regulation in 2023 -- A Conversation with Richard E. Engler, Ph.D.” and
  • “What to Expect on Capitol Hill and at EPA OCSPP in 2023 -- A Conversation with Jim Aidala.”
• B&C’s informative blogs and newsletters -- subscribe here.

• Email This
• Print

Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST).

• TSCA in 2023
  • Final rules for mitigating risks identified in EPA risk assessments
  • Proposed rules for mitigating risks identified in EPA risk assessments
  • Risk evaluations -- assumptions and methods
  • Test orders to impose chemical testing requirements
  • New chemicals update on premanufacture notice (PMN) issues
• Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 2023
  • Congressional renewal of Pesticide Registration Improvement Act (PRIA) (registration fee program) for an additional five years
  • Endangered Species Act (ESA) program plans and progress
  • Program priorities for 2023, including environmental justice, registration review deadlines, staffing and budget, and possible 2023 Farm Bill actions

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the fiscal year 2022 appropriations bill to consider the “full” implementation costs of the law. According to EPA, updating TSCA fees will strengthen its ability to implement successfully TSCA in a way that is both protective and sustainable and significantly improve on-time performance and quality. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. Stakeholders who wish to provide oral comments during the webinar are asked to register by December 1, 2022. Comments on the supplemental proposed rule are due January 17, 2023. More information on the supplemental proposed rule will be available in our forthcoming memorandum.

• Email This
• Print

This webinar has been rescheduled from December 7, 2022. The new and correct date and time is December 14, 2022, 12:00 p.m. – 1:00 p.m. (EST).

Registration is open for the "Articles under TSCA" webinar on December 14, 2022, 12:00 p.m. - 1:00 p.m. (EST).

When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the regulation of chemicals in “articles,” generally meaning finished products or manufactured goods. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many in the regulated industries off guard and reflects a significant shift in U.S. chemical regulation policy. This change in policy affects all commercial entities that deal with a physical product, as they must now become familiar with the law, its requirements, and the chemical makeup of their finished goods. This webinar will cover the policy changes that led to the regulation of articles, EPA’s authority to regulate these articles, and what companies need to know to stay in compliance.
 
Register now to join Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C^®) webinar “Articles under TSCA.”

Topics Covered:  

• What products in commerce qualify as articles;
   
• What EPA’s change in approach means as a practical matter for the supply chain; and
   
• The importance and challenges of transparency in product sourcing.

Speakers Include:

Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.
 
Eve Gartner is the Managing Attorney for the Toxic Exposure and Health Program at Earthjustice, where she leads a team of professionals charged with protecting human health from toxic chemicals. Ms. Gartner works with groups around the country to develop state policies that will reduce exposures to chemicals and pesticides. She also serves as part of Project TENDR, a collaboration of scientists, health professionals, and children’s health advocates working to develop policy approaches to address the link between environmental exposure and neurodevelopmental disorders.
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 4, 2022, that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As reported in our October 11, 2022, memorandum, in October 2022, EPA announced an innovative effort intended to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs are used in batteries, electric vehicles, semiconductors, and renewable energy generation, making them a vital part of clean energy sectors.
 
EPA states that the kickoff webinar will provide statutory and regulatory background, including the related compliance advisory, a broad overview of the approach for risk assessment and risk management, and information on the Toxic Substances Control Act (TSCA) Inventory, nomenclature, and the bona fide process for those seeking to find out if their MMOs are already on the Inventory.
 
According to EPA, the second webinar, currently targeted for early 2023, will go into greater detail on the standardized risk assessment approach, present various case scenarios and a decision tree for identifying potential hazards and risks, and provide tips on risk calculators, tools, and models that are used for the risk assessment.
 
EPA encourages stakeholders to provide feedback, ideas, and questions at the kickoff webinar. This will help EPA supplement the information that will be shared at the second webinar and any follow-up communication on the new approach.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 27, 2022, in its Computational Toxicology and Exposure Communities of Practice (CompTox Communities of Practice) series on “Analysis of High-Throughput Profiling Assays in Chemical Safety Screening.” The abstract for the webinar states that recent technological advancements have led to the development of new high-throughput profiling methods, such as transcriptomics, that can be used to screen rapidly chemicals for potential hazards. Decreasing costs have made it feasible to profile all protein-coding genes across thousands of samples, allowing for broad evaluation of many target pathways and modes of action in a single screening assay. Similarly, it is now possible to apply high-content imaging across many different chemical exposures to capture a variety of changes in cell morphology. According to the abstract, such methods have been applied to in vitro chemical screening studies, including screening studies at EPA that were recently released on the CompTox Chemicals Dashboard. These types of data can be used for both hazard prediction and potency estimation, thereby informing risk assessments and prioritizing chemicals for further testing.
 
The abstract notes that assessing the reliability and reproducibility of these screening platforms is critical to their utility in regulatory applications. While these platforms often have lower signal-to-noise ratios compared to individual targeted assays, the resulting data are also high-dimensional, allowing for the analysis of consistent trends across many molecular endpoints. The webinar will provide an overview of computational methods and best practices for reliable analysis of high-throughput profiling data in a variety of use cases and will highlight the recent data release on the CompTox Chemicals Dashboard. Registration is open.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly-accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar will provide an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application. Registration is open.

• Email This
• Print

Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995.

During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), Richard E. Engler, Ph.D., Director of Chemistry, B&C, and James W. Cox, M.S., Senior Scientist, B&C, discussed examples of EPA’s use and development of non-vertebrate testing strategies, successful collaborations between EPA and external partners to advance understanding and use of NAMs, and the need for EPA and stakeholders to approach implementation of NAMs with an “innovation mindset” that fulfills the requirements under TSCA. Lynn L. Bergeson, Managing Partner, B&C, moderated.

We encourage you to view the webinar, listen to the All Things Chemical^® episode “Animal Testing and New TSCA,” and subscribe to B&C’s informative blogs and newsletters.

• Email This
• Print