By Lynn L. Bergeson and Carla N. Hutton
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. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.
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 worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.
During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:
- Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
- In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
- Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.
As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:
- How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
- The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.
More information is available in our July 28, 2022, memorandum.
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 submitters supplementing incomplete initial new chemicals review submissions, contributing to delays in EPA’s review of these chemicals, and stretching already limited resources. EPA notes that it shares an interest with stakeholders in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA states that it anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVE), which constitute about 60 percent of Toxic Substances Control Act (TSCA) Section 5 submissions annually.
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 effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.
Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA New Approach Methodologies,” a complimentary webinar featuring Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH. The 2016 amendments to TSCA require 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 scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”
These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:
- Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
- Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions;
- Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
- Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.
By Lynn L. Bergeson
On June 22, 2022, the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended TSCA. The only witness present was Michal Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The recording of the hearing is available here.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On May 12, 2022, EPA published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under TSCA. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022. Additional information is available here.
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 program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:
- Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
- Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
- Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
- Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances; and
- Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.
More information on EPA’s draft document is available in our March 14, 2022, memorandum.
B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into 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. Register here.
Full Agenda (subject to change):
|9:15 a.m. - 9:30 a.m.
||Welcome and Overview of Virtual Forum
|9:30 a.m. - 10:00 a.m.
||Morning Keynote Discussion
Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)
|10:15 a.m. - 11:45 a.m.
||Panel 1: The Interface of Science and Policy under TSCA
This panel will examine key issues at the interface of science and policy under TSCA, including the continuing role of animal studies in supporting risk evaluations, the potential use of New Approach Methodologies (NAM) to inform safety determinations for new and existing chemicals, scientific integrity and the TSCA program, methodologies for systematic review, and more.
Moderated by James J. Jones, President, J. Jones Environmental
|12:00 p.m. - 1:30 p.m.
||Panel 2: New Chemical Review
The TSCA New Chemicals Program was strengthened in the 2016 Lautenberg Amendments and what the law requires has been vigorously debated. This panel will discuss opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, use of Significant New Use Rules (SNUR) and Section 5(e) orders, and more.
Moderated by Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
|1:45 p.m. - 3:15 p.m.
||Panel 3: Risk Evaluation and Management
With the “first 10” evaluations completed, this panel will look back at the lessons learned and areas for improvement; discuss EPA efforts to enhance these evaluations through risk determinations for fenceline communities, revised worker protection assumptions, and the “whole chemical approach”; examine the asbestos risk management proposal and other emerging risk management approaches; evaluate the impact of resource constraints on meeting statutory deadlines; discuss the role of environmental justice considerations; and more.
Moderated by Robert M. Sussman, Principal, Sussman & Associates
|3:30 p.m. - 5:00 p.m.
||Panel 4: TSCA Regulation of Articles
TSCA requirements can apply to “articles,” a manufactured good or finished product. This panel will discuss the potential role of articles as contributors to health and environmental concerns, EPA’s push to remove traditional exemptions of articles and resulting compliance and implementation challenges, potential new rules for per- and polyfluoroalkyl substances (PFAS) and asbestos requiring reporting on articles, and the application of SNURs and risk management rules to articles, and more.
Moderated by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C.
|5:00 p.m. – 5:10 p.m.
||Concluding Remarks and Adjournment
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. Full program and registration available online.
Materials from the 2021 conference are available at https://www.lawbc.com/news/recording-of-tsca-reform-five-years-later-conference-and-other-resources-av
The American Chemical Society’s Green Chemistry Institute® (ACS GCI) will host its 26th Annual Green Chemistry & Engineering (GC&E) Conference in Reston, VA, from June 6 to June 8, 2022. The theme for the 2022 GC&E Conference is “Thinking in Systems: Designing for Sustainable Use.” This theme will explore how green and sustainable chemistry and engineering contribute to the development and commercialization of products for sustainable use.
On June 6, 2022,B&C will moderate a session organized by B&C’s Director of Chemistry, Richard E. Engler, Ph.D., and Ligia Duarte Botelho, Regulatory Assistant, titled “The Role of Sustainable Thinking in New Chemical Reviews.” B&C’s symposium will explore the “new chemical bias” and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Organized as a panel discussion, company representatives, EPA scientists, and invited speakers from non-governmental organizations will explore the “new chemicals bias,” as it is called, and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Attendees will gain an understanding of the regulatory landscape of TSCA implementation and how EPA might change its approach to reduce barriers to circular economy innovations. Ms. Botelho, the moderator, will introduce the topic, and following brief introductory remarks, the panelists will engage in 20 minutes of practical discussion, including a question and answer session to engage with the audience. Registration information is available here.