SAVE THE DATE
NEW TSCA AT FIVE
June 30, 2021
This June marks the fifth anniversary of the enactment of the game-changing Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) that amended the Toxic Substances Control Act (TSCA). With a new Administration and the relentless pace of regulatory developments related to Lautenberg implementation, there are many issues to consider and problems to solve.
The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the fifth annual conference providing updates and insights regarding the current state of TSCA implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in new chemical review, existing chemical risk management provisions, and TSCA’s role in achieving environmental justice, among other topics.
As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry, and academia will convene to inform, analyze, discuss, and debate the most pressing issues related to TSCA with regulatory practitioners and other stakeholder attendees.
Detailed program and registration information to come. SAVE THE DATE!
March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.
This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.
Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)
Jon Hellerstein, CIH, CSP, a career environmental health professional
Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies
Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.
In addition to receiving 1.5 contact hours, participants will learn:
- How product stewards can integrate product stewardship into business continuity and crisis management.
- What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
- How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.
Make sure to register now for what promises to be a timely, resourceful, and interesting event!
By Lynn L. Bergeson and Carla N. Hutton
The House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on March 17, 2021, on “Brain Drain: Rebuilding the Federal Scientific Workforce.” The Subcommittee heard from the following witnesses:
- Ms. Candice Wright, Acting Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
- Mr. Max Stier, President and Chief Executive Officer (CEO), Partnership for Public Service;
- Dr. Andrew Rosenberg, Director of the Center for Science and Democracy, Union of Concerned Scientists; and
- Dr. Betsy Southerland, Former Director of Science and Technology, Office of Water, U.S. Environmental Protection Agency (EPA).
During the hearing, Subcommittee Chair Bill Foster (D-IL) submitted a Majority staff report into the record on “trends in the Science, Technology, Engineering and Mathematics (STEM) workforce within federal science agencies following the sequestration in the early 2010s that impacted staffing within federal agencies and workforce-related actions taken by the Trump Administration that contributed to destabilizing the federal STEM workforce over the last four years.” The staff report, “Scientific Brain Drain: Quantifying the Decline of the Federal Scientific Workforce,” evaluates how STEM civil service employment has expanded or contracted over the past decade at several federal agencies, including EPA. According to the Committee’s press release, the report finds significant declines in the STEM workforce at EPA, particularly within the Office of Research and Development, the Department of Energy (DOE), and the National Oceanic and Atmospheric Administration (NOAA), as well as that racial and ethnic employment gaps are significant in STEM fields compared to the total federal workforce. The press release states that “[t]hese trends suggest the United States may need to recommit to promoting U.S. competitiveness in science and innovation, especially as China redoubles its investments in advanced technology and commitment to a pipeline of highly educated STEM workers.”
By Lynn L. Bergeson and Carla N. Hutton
On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods. As reported in our February 17, 2021, blog item, on February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations. In its final report, the Committee to Review EPA’s TSCA Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).” EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations. According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the Integrated Risk Information System (IRIS) Program. In their March 4, 2021, press release, the Republicans state that the IRIS Program “has come under fire from Congress and independent reviewers like the National Academies for its inconsistent process, lack of transparency, and failure to complete assessments in a timely fashion.” The Republicans ask for EPA’s commitment that, “in accordance with congressional intent to operate with flexibility and speed, TSCA does not fully or consistently adopt program processes or procedures implemented by IRIS.” If EPA incorporates elements developed by the IRIS Program into TSCA, the Republicans “expect the Agency to assess their benefits and impacts thoroughly, while also adhering to the statutorily prescribed deadlines and scientific standards mandated.”
By Lynn L. Bergeson and Carla N. Hutton
The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a fully remote hearing on March 10, 2021, on “The Path Forward: Restoring the Vital Mission of EPA.” According to the House Energy and Commerce Committee’s March 3, 2021, press release, the hearing will examine the “critical need to restore the mission” of the U.S. Environmental Protection Agency (EPA) and how EPA “can address climate change and other urgent challenges to the nation’s environment and public health.” Subcommittee members will hear “from former EPA leaders about what steps must be taken to undo the damage done to the agency over the last four years and to re-empower it to fulfill its mission.” The hearing will be available via live webcast.
By Lynn L. Bergeson and Carla N. Hutton
On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation. According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals. GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas, states that this high-risk area declined in the monitoring criterion from a partially met rating in 2019 to a not met rating in 2021; three criteria in each of the two segments declined to a not met rating in 2021. GAO notes that the Integrated Risk Information System (IRIS) Program did not issue a completed chemical assessment between August 2018 and December 2020, and EPA (1) did not indicate how it was monitoring its assessment nomination process to ensure it was generating quality information about chemical assessment needs; and (2) lacked implementation steps and resource information in its strategic plan and metrics to define progress in the IRIS Program. Additionally, according to GAO, EPA’s programs supporting the Toxic Substances Control Act (TSCA) (1) did not complete workforce or workload planning to ensure the agency can meet TSCA deadlines; and (2) did not meet initial statutory deadlines for releasing its first ten chemical risk evaluations.
In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.
In the US, all new chemicals must be reviewed by the US EPA before they can enter commerce. The agency looks at new chemicals to determine whether their manufacturing, processing and use would adversely affect people or the environment. If the EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through the EPA for review and have been allowed into US commerce.
In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).
By Lynn L. Bergeson and Carla N. Hutton
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations. The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials. In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).” The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.” The final report includes the following summary of the Committee’s general recommendations:
- OPPT’s approach to systematic review does not adequately meet the state of the practice. The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
- With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
- The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.” The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders. The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams. In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX). Following these existing guidelines would improve transparency of the assessments.
- The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process. Throughout the final report, the Committee points to problems of documentation. The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”
The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.” According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations. According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations. EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.” The 2018 Application of Systematic Review document “represented EPA’s practices at that time.” According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program. EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”
The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. A national faculty of seasoned private practitioners, governmental officials, law professors, and public interest advocates will cover what to expect from the change of administrations in Washington D.C., with Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, former Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency, presenting "Chemicals Regulation: Latest Developments" on February 25, 2021. This course will cover:
- Biden-Harris Administration priorities with respect to chemical policy and regulation;
- Potential likelihood of shifts in Toxic Substances Control Act (TSCA) implementation and agricultural chemical policy;
- Key recent European Union (EU) initiatives expected to influence domestic initiatives; and
- Anticipated changes with respect to emerging contaminants and environmental justice policy development.
Register online for the full three-part webcast, or register separately for Part 1 on February 24, Part 2 on February 25, and Part 3 on February 26.
This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.
This week I had my final visit with the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator Alexandra Dunn. As many of our listeners know, Alex Dunn lead the Office of Chemical Safety and Pollution Prevention and was responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively. Alex has done a superb job since taking office in early 2019, and her steady hand in managing TSCA implementation and a wide range of hot button pesticide issues has been effective and comforting.
Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of the States.
We focused our discussion on a look back at Alex’s many achievements since taking office, including implementation of the amendments to TSCA, which Congress enacted in 2016. Alex also addressed some of the most controversial pesticides -- glyphosate, dicamba, and chlorpyrifos, among others -- all the while implementing one of the most consequential pieces of environmental legislation ever passed by Congress.
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