A Timely and Essential Complimentary Conference
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. Leading panelists will reflect on the challenges and accomplishments, while offering unique insights into the decision-making process of top U.S. Environmental Protection Agency (EPA) officials.
Confirmed speakers from government, non-governmental organizations (NGO), industry, and academia include:
- Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean of the Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University
- Michal Ilana Freedhoff, Ph.D., Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA
- Dianne Barton, Council Chair, National Tribal Toxics Council
- Lynn L. Bergeson, Managing Partner, B&C
- Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.
- Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP
- Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
- Dennis R. Deziel, Senior Government Affairs Advisor, B&C, and former Administrator, Region I, EPA
- Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
- Richard E. Engler, Ph.D., Director of Chemistry, B&C
- Penny Fenner-Crisp, Ph.D., Environmental Protection Network
- Scott Fulton, President, ELI
- Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
- Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.
- Liz Hitchcock, Director, Safer Chemicals Healthy Families
- Jon Kalmuss-Katz, Supervising Staff Attorney, Earthjustice
- Marianne Engelman Lado, Deputy General Counsel, Environmental Initiatives, Office of General Counsel, EPA
- Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC
- John Pendergrass, Vice President, Programs & Publications, ELI
- Betsy Southerland, Issue Team, TSCA, Environmental Protection Network
- Robert M. Sussman, Principal, Sussman & Associates
- Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
Additional speakers will be announced as they are confirmed.
Mark your calendar for June 30, 2021, to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in this day-long exploration of the issues and regulations surrounding TSCA.
More information about “TSCA Reform - Five Years Later” is available at the ELI website and a recording will be made available to all participants after the conference. Details about previous TSCA Reform events can be found at “TSCA Reform – Four Years Later,” “TSCA: Three Years Later,” “TSCA Reform at 2 Years” and “TSCA Reform: One Year Later.”
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
Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson will join the Retail Industry Leaders Association’s (RILA) Retail Compliance Center (RCC) on June 10, 2021, at 2:00 p.m. (EDT) to present a webinar entitled “TSCA: It Is Not What You May Think.” For decades, the Toxic Substances Control Act (TSCA) has been regarded as a “chemical producer” law that retailers, product manufacturers, and other “article” manufacturers could, for the most part, comfortably ignore. Not anymore. TSCA was significantly amended in 2016, and the U.S. Environmental Protection Agency’s (EPA) implementation of “new TSCA” has drawn many, often unsuspecting, entities in the value chain -- including retailers -- squarely into TSCA’s broad reach. The “new normal” may not be what you want, but this webinar tells you what you need to know!
In this webinar, attendees will learn:
- What TSCA is and why it matters to retailers;
- What retailers need to know about their products; and
- What steps to take after the webinar.
This webinar is intended for large and small retailers, product stewards, sustainability and circularity professionals, and retail compliance professionals, as well as those throughout the product supply chain. Registration is open for the free webinar.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a final rule on May 18, 2021, that will rescind the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts and circumstances, and unduly restricts the EPA's ability to provide timely guidance on which the public can confidently rely.” EPA states that it will continue to make Agency guidance available to the public at https://www.epa.gov. In addition, EPA will comply with all statutory obligations pertaining to posting documents for public accessibility. EPA will also continue its practice, as appropriate, of soliciting stakeholder input on guidance of significant stakeholder and public interest. EPA notes that consistent with the Administrative Procedure Act (APA), stakeholders may still petition EPA at any time regarding its regulatory programs, including requests to issue, amend, or repeal EPA guidance. The final rule will be effective when published in the Federal Register.
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!
By Lynn L. Bergeson
EPA announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures. EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.” Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.
EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future. EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.
EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.
Bergeson & Campbell, P.C. Commentary
The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable. This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5. In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order. EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk. It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain. EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise. The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process. A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.” Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision. If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data. In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.
EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development. B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting. A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector. The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so. Today’s unexplained reversal is difficult to reconcile with these facts. If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016. As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.
By Richard E. Engler, Ph.D.
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 United States, all new chemicals must be reviewed by the U.S. Environmental Protection Agency (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 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 EPA for review and have been allowed into U.S. 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 Ligia Duarte Botelho, M.A.
EPA announced that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule to give stakeholders more time to review and comment. The current comment period was set to close on February 25, 2021. Comments are now due on March 27, 2021. Information on the proposed updates is available in the Bergeson & Campbell, P.C. (B&C®) December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”
On February 18, 2021, EPA held a virtual public meeting on the TSCA Fees Rule, allowing stakeholders to provide input on the proposed rulemaking. One of the main concerns by industry stakeholders was related to fees collection under TSCA Section 4. Stakeholders reported that EPA should not collect such fees under Section 4 because the same fees are collected under Section 5. The Alliance for Automotive Innovation proposed instead a tiered fees structure, given that the rule as proposed includes downstream user fees, which would double fees within the supply chain.
On the other hand, representatives from the Environmental Defense Fund (EDF) expressed opposition to the exemptions outlined in the proposed rule and criticized EPA for relying on voluntary information requests.
By Lynn L. Bergeson
EPA published on February 8, 2021, a periodic update of the TSCA confidential business information (CBI) review statistics. TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim:
- Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and
- Review and make determinations on a representative subset of at least 25 percent of other CBI claims that are not exempt from substantiation and review.
The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020. In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.
EPA states that making this information publicly available continues to demonstrate its commitment to transparency while fulfilling its responsibilities under TSCA. EPA notes that it has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.
By Lynn L. Bergeson
On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected. TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary. The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined. The proposed updates include:
- Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for R&D purposes, and companies that produce a chemical as a non-isolated intermediate;
- Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
- Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
- Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
- Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
- Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
- Adding three new fee categories, two associated with new chemical activities and one associated with test orders.
Comments are due February 25, 2021. More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.