Posted on May 24, 2023 by Lynn L. BergesonBergeson & 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 groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing EPA decisions under TSCA Sections 5 and 6. Other consequential rulemakings involving per- and polyfluoroalkyl substances (PFAS) reporting and confidential business information (CBI) protections are equally significant, and all are likely to inspire significant disruption in the regulated community.
Watch the webinar now.
Posted on May 16, 2023 by Lynn L. BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2023, that it will hold a webinar on June 7, 2023, at 1:00 p.m. (EDT) on its proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would ban all consumer uses and most commercial uses of methylene chloride, “a chemical in commercial and consumer products known to cause serious health risks and even death.” As reported in our April 25, 2023, memorandum, EPA proposes prohibitions and protections, with a rapid phase-down for manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, a majority of which would be fully implemented in 15 months after the final rule is issued. For industrial manufacturing, industrial processing, laboratory use, and federal uses that EPA is not proposing to prohibit, EPA proposes a workplace chemical protection program (WCPP) with strict exposure limits to protect workers better. The WCPP would require employers and others covered by it to comply with safety requirements within one year. They would also be required to periodically monitor their workplaces to ensure that workers and others on site are not being exposed to levels of methylene chloride that would lead to an unreasonable risk. Comments on the proposed rule are due July 3, 2023.
According to EPA, the webinar “will be useful for anyone looking for an overview of the proposed regulatory action or to provide input on the proposed program, including industry groups, nonprofit organizations, Tribes, and other stakeholders.” EPA states that it is particularly looking for participation from employers and workers “who can give perspective on the feasibility and efficacy of the proposed requirement for worker protections.”
Participants can register as listeners or to make prepared remarks. To provide remarks during the webinar, registration must be completed by May 24, 2023, at 5:00 p.m. (EDT). Registration as a listener can be completed up until the start of the webinar. Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com. EPA states that it will provide copies of the presentation material on its website following the webinar.
Posted on May 02, 2023 by Lynn L. BergesonBergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to announce the seventh annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform -- Seven Years Later,” to occur Thursday, June 29, 2023. This complimentary virtual conference featuring speakers from the U.S. Environmental Protection Agency (EPA) and non-governmental and industry stakeholders will provide updates on a host of topics, including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more.
Save the date to join B&C, ELI, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA.
Materials from the 2022 “TSCA Reform -- Six Years Later” conference are available to ELI Members at https://www.eli.org/events/tsca-reform-six-years-later.
Posted on April 19, 2023 by Lynn L. Bergeson
May 17, 2023
11:00 a.m. - 12:00 p.m. EDT
REGISTER NOW
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing EPA decisions under TSCA Sections 5 and 6. Other consequential rulemakings involving per- and polyfluoroalkyl substance (PFAS) reporting and confidential business information (CBI) protections are equally significant, and all are likely to inspire significant disruption in the regulated community. Join us for an intense one-hour update on these and other issues in a discussion with Dr. Anna B. Lowit, OPPT’s Senior Science Advisor, and Bergeson & Campbell, P.C.’s (B&C ®) Director of Chemistry, Dr. Richard E. Engler.
Topics Covered:
- New Approach Methodologies
- Systematic Review
- Cumulative Risk Assessment
- Update on Section 6 Risk Evaluations
- The Latest TSCA Rulemakings, Including PFAS Reporting, CBI, and TSCA Fees
Speakers Include:
Anna B Lowit, Ph.D., Senior Science Advisor, OPPT, advises on a diversity of science policy issues. Dr. Lowit previously served at Senior Science Advisor for EPA’s Office of Pesticide Programs. She is currently co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods.
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 OPPT and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, and pre-notice and post-review meetings with submitters to resolve complex cases.
Lynn L. Bergeson, Managing Partner, B&C, 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 pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and analog global chemical product programs. Ms. Bergeson is Chair of the International Bar Association (IBA) Agriculture and Food Section, is Immediate Past President of the Product Stewardship Society (PSS) and serves on the Executive Committee of the American College of Environmental Lawyers (ACOEL).
Posted on March 13, 2023 by Lynn L. BergesonBy 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.
Posted on February 13, 2023 by Lynn L. BergesonBy 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.
Posted on February 02, 2023 by Lynn L. BergesonBergeson & 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:
Posted on January 11, 2023 by Lynn L. BergesonRegistration 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).
This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental Protection Agency (EPA) actions, particularly with respect to implementation of the 2016 amendments of the Toxic Substances Control Act (TSCA). Concepts core to the Act, including “reasonably foreseen,” “to the extent necessary,” “systematic review,” and “best available science,” continue to evolve and not always in predictable, coherent, and consistent ways. Similar policy shifts are seen in the agricultural and biocidal area, with perhaps less dramatic effect. How the 2024 general election will influence EPA’s policy choices is unclear. In that the election cycle has already begun, we caution all to buckle up and prepare for what we expect will be an eventful, fascinating year.
Register now to join Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (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 for this informative and forward-looking webinar.
Topics Covered:
- 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
Speakers Include:
James V. Aidala, Senior Government Affairs Consultant with B&C, has been intimately involved with the TSCA and FIFRA legislative reauthorization and key regulatory matters for over four decades. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at EPA for pesticide and chemical regulation and provides clients with vital insights into not only relevant current policies of EPA and sister agencies, but also the way these policies have been or are likely to be formulated to help clients more successfully address regulatory matters.
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.
Dennis R. Deziel, Senior Government Affairs Advisor with B&C, has an extraordinary depth of experience and knowledge of the regulatory process and government advocacy, honed through a career of senior leadership roles at EPA and the U.S. Department of Energy (DOE), among other significant positions. As Administrator of EPA Region 1, Mr. Deziel led the region’s 500-plus employees in managing energy, environment, and sustainability policy and programs, building coalitions across a wide range of stakeholders, including members of Congress, governors, federal and state government officials, industry, non-governmental organizations (NGO), and local communities.
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.
Posted on November 18, 2022 by Lynn L. BergesonBy 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.
Posted on November 17, 2022 by Lynn L. BergesonThis 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.
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