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.
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).
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.”
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.
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.
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.”
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.
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.
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.
On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020. Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first two or three years after enactment, really through 2019, setting up the bones of the program, the regulations, the structure, the fees rule, and now we’ve begun the deep process of looking at each chemical [for risk evaluation].” The conversation continued with discussion regarding how chemicals are selected for evaluation, surprises EPA encountered while making low-priority determinations, and what can be expected through the remainder of 2020. Ms. Dunn and Ms. Bergeson agreed that as more chemicals go through this review process, the quantity and type of information needed will standardize, leading to more predictability for all stakeholders. Now that a system is evolving, EPA plans to identify data gaps early to provide time to strategize how to acquire as much information as is required to evaluate properly a chemical on schedule and with minimal additional costs.
A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.
Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, product defense, and associated business issues.