By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). EPA states that it recognizes its responsibility to identify and implement opportunities to reduce costs as it incorporates lessons learned since the Lautenberg Act was enacted and builds the scientific, regulatory, and other infrastructure needed to implement the program effectively. For example:

• The resources included in President Biden’s fiscal year (FY) 2023 budget request would allow EPA to modernize its information technology (IT) systems, which at times hinder and significantly slow chemical review work. These improvements will ultimately reduce TSCA implementation costs;
• The resources included in the FY 2023 budget request would allow EPA to increase and further diversify the expertise of the TSCA program’s scientific workforce, which will reduce re-work and enable more timely and robust chemical reviews, and thus ultimately reduce TSCA implementation costs;
• As EPA further develops its scientific and regulatory tools (including but not limited to systematic review, techniques to assess chemical risks to potentially exposed and susceptible subpopulations, and potential measures to address occupational safety), EPA expects costs of developing these tools to decrease;
• EPA has made significant efforts to enhance its intra- and inter-agency coordination to improve the efficiency of the prioritization, risk evaluation, and regulatory processes by identifying and resolving concerns earlier, thus increasing EPA’s capacity to implement the Lautenberg Act in accordance with statutory deadlines; and
• Many of the first 30 chemicals subject to the amended TSCA risk evaluation and regulatory process are high production volume substances used by many sectors for many purposes, and about which health and environmental concerns are known to exist. As EPA continues to meet the TSCA mandate continuously to select and evaluate chemical substances from among the thousands of chemical substances in commerce, it is reasonable to expect that a reduction in the scope and complexity of each risk evaluation, as well as the associated risk management actions, would reduce implementation costs.

According to the report, the combination of the resources included in Biden’s FY 2023 budget request, an amended fees rule, and EPA’s ongoing efforts to build and improve the scientific, regulatory, and other infrastructure needed to implement TSCA more efficiently should, over time, reduce the levels of resources needed in the future. Our forthcoming memorandum will include a detailed summary of the proposed rule and an insightful commentary.

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By Lynn L. Bergeson 

Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit the U.S. Environmental Protection Agency’s (EPA) authority in implementing Congress’s 2016 amendments to the Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
 
The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C^®) for Chemical Watch, is available here.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 22, 2022, the Senate Committee on Environment and Public Works will hold 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 the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).

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By Lynn L. Bergeson and Carla N. Hutton
 
The House Energy and Commerce Subcommittee on Environment and Climate Change will hold a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” According to the October 20, 2021, press release issued by the House Committee on Energy and Commerce, Representatives Frank Pallone, Jr. (D-NJ), Chair of the Committee, and Paul Tonko (D-NY), Chair of the Subcommittee, stated that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) made “crucial” reforms to the Toxic Substances Control Act (TSCA) “that improve how the federal government protects Americans from dangerous chemicals, and now we must ensure those reforms are implemented effectively and honestly.” Pallone and Tonko stated that during the previous administration, “chemical risk evaluations were skewed in favor of industry to the detriment of workers and communities. We must protect consumers from exposure to toxic substances and ensure the Environmental Protection Agency is using the tools Congress granted it to protect public health.” The Subcommittee will discuss the implementation of the Lautenberg Act and the U.S. Environmental Protection Agency’s (EPA) “efforts to get TSCA back on track.”

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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.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation.  According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals.  GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas, states that this high-risk area declined in the monitoring criterion from a partially met rating in 2019 to a not met rating in 2021; three criteria in each of the two segments declined to a not met rating in 2021.  GAO notes that the Integrated Risk Information System (IRIS) Program did not issue a completed chemical assessment between August 2018 and December 2020, and EPA (1) did not indicate how it was monitoring its assessment nomination process to ensure it was generating quality information about chemical assessment needs; and (2) lacked implementation steps and resource information in its strategic plan and metrics to define progress in the IRIS Program.  Additionally, according to GAO, EPA’s programs supporting the Toxic Substances Control Act (TSCA) (1) did not complete workforce or workload planning to ensure the agency can meet TSCA deadlines; and (2) did not meet initial statutory deadlines for releasing its first ten chemical risk evaluations.

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By Lynn L. Bergeson and Carla N. Hutton

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.”  The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.”  The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance.  EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document.  EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents.  The final rule will be effective 30 days after publication in the Federal Register.  More information will be available in a forthcoming memorandum that will be posted on our website.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA).  Environmental Defense Fund v. Wheeler, No. 1:20-cv-762.  On July 27, 2020, the parties submitted a joint case management statement.  According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial.  The parties state that they disagree about whether administrative records exist and the availability and scope of discovery, however.  Resolving these questions will implicate the timing for any discovery, the appropriate deadline for final amended pleadings, and the appropriate schedule for summary judgment briefing.  The parties note that they are currently discussing options to resolve as many of these questions as possible and that they believe successfully resolving them could reduce the number and complexity of procedural issues before the court.  In particular, according to the statement, the parties are discussing options to narrow the scope of factual and legal issues presented, which may minimize the potential for future disputes over the availability and scope of discovery.  The parties propose to submit an updated case management statement no later than August 31, 2020.

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This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois.  As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee.  In this capacity, Congressman Shimkus has become a rock star in the industrial chemical community, given his tireless efforts to modernize the Toxic Substances Control Act (TSCA) , which of course resulted in passage four years ago of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

Given Congressman Shimkus’s extensive involvement in and personal commitment to reforming TSCA, our conversation focused on the efforts that have been under way since June 2016 to implement the massive and complicated new law.  We address many aspects of Lautenberg’s implementation, not just by the U.S. Environmental Protection Agency (EPA), but also efforts under way by other industrial chemical stakeholders, including industry, non-government organizations (NGOs), states, and the courts.  We discuss the many, many rulemakings EPA has issued since 2016 and survey the next leg of EPA’s journey to implement the new law over the next 12 to 24 months, which will be extremely busy.  Congressman Shimkus is as passionate today as he was four years ago about chemical safety, as you will hear in this recording.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

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