Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA). The draft scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful in preparing the final scope document. Comments are due October 25, 2021.
 
EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of D4 in the risk evaluation. According to the draft scope document, D4 is manufactured (including imported) in the United States. The chemical is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The draft scope document states that the identified processing activities also include the repackaging and recycling of D4. D4 is primarily used to make other silicone chemicals and as an ingredient in consumer products regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA). Commercial uses include adhesives and sealants, automotive care products, paints and coatings, and other plastic and rubber products. Additional consumer uses include adhesives and sealants, automotive care products, laundry and dishwashing products, paints and coatings, and other plastic and rubber products.
 
EPA notes that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in June 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility.”
 
According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information on the policy changes is available in our July 1, 2021, memorandum.
 
The final scope documents explain EPA’s plan for the risk evaluations, including the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA will consider. The documents also include a description of the reasonably available information and the best available science approaches that EPA will use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods EPA will use to assess health and environmental risks; and a plan for peer review. More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
 
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to pollutants and non-chemical stressors during early lifestages may be crucial determinants of lifetime health. Exposures to cumulative mixtures of chemicals, along with other stressors, such as poverty, limited access to services, and changing environmental conditions, may pose developmental and lifelong health risks. According to EPA, accurate and comprehensive assessments of cumulative impacts are needed to make sound decisions regarding risk reduction, mitigation, and prevention measures. Each center will focus on two individual research projects:

  • Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina:
    • Evaluating the Causal Impacts of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will identify the occurrences and types of chemicals found in toddlers’ caregiving environments and evaluate how these cumulative chemical exposures are associated with neurodevelopmental functioning in early childhood; and
    • Investigating Whether the Caregiving Environment Moderates the Impact of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will investigate whether home caregiving environments alter the impacts of early life chemical exposures on neurodevelopmental outcomes in early childhood.
  • University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina:
    • Early Life Exposure and Neurobehavioral Development -- Researchers will leverage an ongoing, longitudinal study of normative brain development, the UNC Baby Connectome Study, to examine the role that early life exposure to phthalates and other chemicals plays in early childhood behavior, memory, language and motor development, and social cognition; and
    • Neural Substrates of Prenatal and Early Life Neurotoxicity Using Non-Invasive Imaging Methods -- Researchers will work to improve the understanding of the relationships between prenatal and early life exposures and structural and functional brain development, particularly in the third trimester of pregnancy, an important time for brain development.

 

By Lynn L. Bergeson and Carla N. Hutton
 
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 14, 2021, the U.S. Environmental Protection Agency (EPA) announced a stewardship program to encourage the voluntary withdrawal of previously granted low volume exemptions (LVE) for per- and polyfluoroalkyl substances (PFAS). According to EPA, the goal of the PFAS LVE Stewardship Program is to stop the ongoing manufacture of PFAS under previously approved LVEs that have not gone through the full pre-manufacture review process under the Toxic Substances Control Act (TSCA). EPA will hold a webinar on July 29, 2021, to provide an overview of the program.
 
EPA states that there are approximately 600 PFAS with currently granted LVEs. Through the program, EPA intends to work with trade associations, non-governmental organizations (NGO), and companies to encourage voluntary withdrawal of the LVEs. According to EPA, it based the new program on a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that were targeted for voluntary withdrawal at the time.
 
To participate in the program, companies with previously granted PFAS LVEs may choose to withdraw voluntarily their LVEs and certify that they will no longer manufacture or import those PFAS. Alternatively, companies may choose to withdraw voluntarily their LVEs following submission and review of a pre-manufacture notice (PMN), “which will provide for a robust safety review and the imposition of appropriate and enforceable protections for human health and the environment.” EPA states that it will provide recognition of program participants on its website.

Tags: PFAS, LVE, Review

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention, including human health and ecological risk assessment and chemical exposure to susceptible life stages and subpopulations. EPA states that in addition to scientific expertise, members also have backgrounds and experiences that will contribute to the diversity of scientific viewpoints, including professional experiences in government, public health, industry, and other groups. According to EPA, TSCA SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 13, 2021, that Amazon’s Climate Pledge Friendly initiative now includes cleaning and other products certified by EPA’s Safer Choice program. According to EPA, Safer Choice is now one of 30 sustainability certifications highlighted under Amazon’s Climate Pledge Friendly initiative that helps customers shop for more than 75,000 products through the company’s online store. EPA notes that highlighting Safer Choice-certified products makes it easier for consumers to locate products that contain safer chemical ingredients without sacrificing quality or performance. Products identified as Climate Pledge Friendly are distinguished on Amazon’s website by an hourglass-with-wings symbol. The company also provides its customers with detailed web pages that include information on how and why products are certified as sustainable.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

Wednesday, June 30, 2021
9:00 a.m. - 4:30 p.m. (EDT)
Register Now

Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Five Years Later.” This complimentary virtual conference marks the fifth 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 will dive into a host of topics, including the systems of risk evaluation and risk management, environmental justice, regulating per- and polyfluoroalkyl substances (PFAS), new chemicals, and more. Register online.

Full Agenda:

9:00 a.m. - 9:30 a.m.

 

Welcome and Overview of Virtual Forum
Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University
9:30 a.m. - 10:00 a.m. Morning Keynote Discussion
Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)

10:00 a.m. - 10:45 a.m.

 

 

 

 

 

 

Panel 1: Risk Evaluation under TSCA
With the EPA under the Trump Administration completing 10 evaluations and the EPA conducting another 23 under the Biden Administration, there are differences of opinion over what the law requires and the best way to assess chemical risks. This panel will share perspectives on these issues and discuss whether and how the new Administration might revisit the 10 completed evaluations.
Panelists:
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.
Penny Fenner-Crisp, Ph.D., Environmental Protection Network
Suzanne Hartigan, Ph.D., Senior Director, Regulatory and Technical Affairs, American Chemistry Council
Jon Kalmuss-Katz, Supervising Senior Attorney, Earthjustice

11:00 a.m. - 11:45 a.m.

 

 

 

 

 

 

Panel 2: Risk Management under TSCA
The new regulatory frontier associated with the 2016 TSCA amendments is determining how best to manage chemical risks found to be unreasonable. This panel will discuss EPA’s authority under the Lautenberg amendments and options for deploying its risk management authority.
Panelists:
Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC, Moderator
Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
Randy S. Rabinowitz, Executive Director, OSH Law Project LLC
Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
Kimberly Wise White, Ph.D., Vice President, Regulatory and Technical Affairs, American Chemistry Council

11:45 a.m. - 12:30 p.m.

 

 

 

 

 

 

Panel 3: TSCA and Environmental Justice
The TSCA amendments offer enormous opportunities to help eliminate environmental injustice by evaluating and managing chemical risks. This panel will consider how TSCA can be leveraged to address concerns regarding environmental justice.
Panelists:
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C., Moderator
Dianne Barton, Council Chair, National Tribal Toxics Council
Marianne Engelman Lado, Deputy General Counsel, Environmental Initiatives, Office of General Counsel, U.S. Environmental Protection Agency
Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.
Adrienne Hollis, Senior Climate Justice and Health Scientist, Union of Concerned Scientists
12:30 p.m. - 1:30 p.m. Luncheon Keynote
Hon. Jeffrey Alan Merkley, U.S. Senator, Oregon (invited)

1:45 p.m. - 2:45 p.m.

 

 

 

 

 

 

Panel 4: New Chemicals Review
The TSCA New Chemicals Program was modified in the 2016 amendments and what the law requires has been vigorously debated. This panel will discuss the evolution of EPA’s implementation of Section 5 under the past Administration and now under the Biden Administration.
Panelists:
Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP, Moderator
Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C.
Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, Natural Resources Defense Council

3:00 p.m. - 3:45 p.m.

 

 

 

 

 

 

 

Panel 5: TSCA and PFAS
This panel will address how TSCA authorities can be used to address concerns about both new and existing PFAS, as this class of substances continues to gain significant attention.
Panelists:
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Dennis R. Deziel, Bergeson & Campbell, P.C. and former Administrator, Region I, U.S. Environmental Protection Agency
Liz Hitchcock, Director, Safer Chemicals, Healthy Families
Robert J. Simon, Vice President, Chemical Products and Technology and Chlorine Chemistry, American Chemistry Council
Betsy Southerland, Issue Team, Toxic Substances Control Act (TSCA), Environmental Protection Network

3:45 p.m. - 4:15 p.m.

 

 

 

 

Panel 6: TSCA Litigation Update
Unsurprisingly, TSCA litigation is on the rise five years into implementation of the new law. This panel will discuss key issues in dispute and where the courts might be headed.
Panelists:
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C., Moderator
Martha E. Marrapese, Partner, Wiley Rein LLP
Gavin McCabe, Special Assistant Attorney General, New York State Office of Attorney General

4:15 p.m. - 4:30 p.m.

 

Concluding Remarks and Adjournment
Scott Fulton, President, Environmental Law Institute
John Pendergrass, Vice President, Programs & Publications, Environmental Law Institute

 
Join ELI, Bergeson & Campbell, P.C., 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.


 
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