Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.
By Lynn L. Bergeson and Carla N. Hutton
On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:
- Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
- Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
- New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
- Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022;
- Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
- 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
- Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
- Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
- Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
- Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
- Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA notes that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule follows a recently-issued final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
- TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.
The Unified Agenda lists the following TSCA rulemaking at the final stage:
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals:
- Goal 1: Tackle the Climate Crisis;
- Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
- Goal 3: Enforce Environmental Laws and Ensure Compliance;
- Goal 4: Ensure Clean and Healthy Air for All Communities;
- Goal 5: Ensure Clean and Safe Water for All Communities;
- Goal 6: Safeguard and Revitalize Communities; and
- Goal 7: Ensure Safety of Chemicals for People and the Environment.
Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:
- By September 30, 2026, complete at least eight High Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations annually within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
- By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
- By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
- By September 30, 2026, complete 78 pesticide registration review cases;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
- By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.
Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:
- By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
- By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.
According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar:
- Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number of chemicals reported.
- EPA responded that the changes to CDR discussed in the webinar presentation would reduce the data collected per chemical and would not impact which chemicals were required to be reported under CDR.
- Whether the data expected to be used to inform the identification of potential candidate chemicals for prioritization was limited to CDR.
- EPA responded that the webinar presentation was not intended to identify all sources of information that would be used for the various steps of the overall existing chemicals process, including informing the identification of the pool of potential candidate chemicals for the prioritization process. Rather, the intent was to identify the data that would be available from either CDR or TDR for use for each step in the process.
- Reasoning behind EPA’s decisions regarding timing of the collection tiers and selected data elements.
- EPA responded that the specifics of what data elements would be included in which collection tiers was under development and that the Agency is interested in comments from EDF or other stakeholders to help inform the TDR proposal.
- Whether EPA had any more details about the post-risk management stage, which was included in the webinar presentation as “TBD.”
- EPA responded that there were no additional details at this time.
More information on EPA’s July 27, 2021, webinar is available in our July 29, 2021, memorandum. As reported in our August 6, 2021, blog item, EPA posted a memorandum in Docket ID EPA-HQ-OPPT-2021-0436 stating that it will not extend the August 16, 2021, comment period stemming from the July 27, 2021, public webinar.
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 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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and increase transparency for stakeholders and the general public.” The strategic plan includes new vision, mission, and values statements for OPPT. Priority areas include:
- New Chemicals: The New Chemicals Program manages potential risks to human health and the environment from chemicals new to the marketplace. The program identifies conditions to be placed on the use of new chemicals before they enter into commerce;
- Existing Chemicals: TSCA requires EPA to evaluate the safety of existing chemicals through prioritization, risk evaluation, and risk management. Ensuring the safety of existing chemicals requires collecting and analyzing information about the chemicals, developing additional information, conducting analyses to evaluate risk, and taking regulatory action on proper conditions of use for each chemical;
- Pollution Prevention/Safer Choice/Toxics Release Inventory (TRI): OPPT supports a suite of programs that are intended to reduce, eliminate, or prevent pollution at its source as an alternative to pollution control and waste disposal. Safer Choice helps consumers, businesses, and purchasers find products that contain ingredients that are safer for human health and the environment. The TRI Program collects information to track industry progress in reducing waste generation and moving toward safer waste management alternatives;
- Transparency and Stakeholder Engagement: OPPT is committed to providing the public with the information needed to understand EPA’s chemical evaluations. It continually seeks more productive means of engaging with interested stakeholders through public comment during rulemaking, Federal Advisory Committee Act (FACA) workgroups, and other means;
- Human Capital: OPPT strives to provide a healthy and supportive working environment, support for career development, and communication on issues that are important to its colleagues. It closely collaborates with its partners in the Office of Chemical Safety and Pollution Prevention’s (OCSPP) Office of Program Support to ensure that the basics of being an OPPT employee, such as timekeeping, personnel actions, and equipment, are easy to manage; and
- Efficiency and Enabling Tools: OPPT’s priority areas depend on a wide range of data from manufacturers, researchers, and the public. Its employees need to know how to work with these data and to have access to tools that facilitate access to and analysis of these data. OPPT is committed to increasing its ability to manage projects effectively through a unified approach that ensures timely deliverables, increases its ability to track its work, and simplifies its processes.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 28, 2021, announcing a 30-day comment period on the Toxic Substances Control Act (TSCA) Interagency Testing Committee’s (ITC) revisions to the Priority Testing List. 86 Fed. Reg. 22414. In the 74th ITC Report, ITC revised the TSCA Section 4(e) Priority Testing List by adding the following 15 high-priority substances designated pursuant to TSCA Section 6(b) and 24 organohalogen flame retardants:
||Chemical Abstracts Service Registry Number
|Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester
|Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)
|Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2- ethylhexyl) ester)
|Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)
|1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
|4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
|Organohalogen Flame Retardants
|2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate
|Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine
|Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester
|Propanoic acid, 2-bromo-, methyl ester
|Tetrabromobisphenol A-bis(2,3-dibromopropyl ether)
|Tetrabromobisphenol A bis(2-hydroxyethyl) ether
|Tetrabromobisphenol A diallyl ether
|Tetrabromobisphenol A dimethyl ether
ITC requests that EPA add these chemical substances and the other five high-priority substances and six organohalogen flame retardants currently on the Priority Testing List to 40 C.F.R. Section 716.120(a), the list of substances subject to the TSCA Section 8(d) Health and Safety Data Reporting rule (40 C.F.R. Part 716). The rule requires manufacturers (including importers) of chemical substances and mixtures added to the Health and Safety Data Reporting rule to submit lists and copies of unpublished health and safety studies to EPA. Comments are due May 28, 2021.
EPA notes that in addition to the chemical substances being added to the Priority Testing List in the 74th ITC Report, the Priority Testing List includes two alkylphenols, 45 High Production Volume (HPV) Challenge Program orphan chemicals, cadmium, a category of cadmium compounds, six non-phthalate plasticizers, 25 phosphate ester flame retardants, two other flame retardants, nine chemicals to which children living near hazardous waste sites may be exposed, and 19 diisocyanates and related compounds.
On March 31, 2021, the Product Stewardship Society (PSS) presented “Product Stewardship and the Pandemic: Surviving and Thriving in Disruptive Times.” Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and PSS President, moderated a lively and informative discussion identifying the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.
- Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies, Inc.;
- Louise Proud, Vice President, Global Environment, Health & Safety, Pfizer;
- Tina Armstrong, Ph.D., Principal Scientist and Vice President, Arcadis; and
- Jon Hellerstein, CIH, CSP, of Global Product Stewardship Solutions.
A recording of the webinar is now available for PSS members and non-members alike to watch on demand via PSS's e-learning portal. The portal also contains a wealth of resources and tools to equip product stewards and enhance the many roles they play in creating successful, sustainable products and solutions.