By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act (TSCA):

• By September 30, 2026, complete at least eight high-priority substance TSCA risk evaluations annually within statutory timelines compared to the FY 2020 baseline of one;
• By September 30, 2026, initiate all TSCA risk management actions within 45 days of the completion of a final existing chemical risk evaluation; and
• By September 30, 2026, review 90 percent of risk management actions for past TSCA new chemical substances reported to the 2020 Chemical Data Reporting Rule (CDR) compared to the FY 2021 baseline of none.

The CJ provides a summary of activities for the Chemical Risk Review and Reduction (CRRR) Program. According to the CJ, in FY 2024, EPA will emphasize the integrity of scientific products, adherence to statutory intent and requirements, and timelines applicable to pre-market review of new chemicals, chemical risk evaluation and management, data development and information collection, the review of confidential business information (CBI) claims, and other statutory requirements. The CJ states that the resources requested are essential for EPA to address its workload, including:

• Maintaining at least 20 EPA-initiated existing chemical risk evaluations in development at all times and completing EPA-initiated existing chemical risk evaluations within the statutory timeframe;
• Having up to five existing chemical risk evaluations requested by manufacturers in development;
• Issuing protective regulations in accordance with statutory timelines addressing all unreasonable risks identified in each risk evaluation;
• Establishing a pipeline of chemicals to be prioritized for future risk evaluation;
• Using test orders and a new strategy for tiered data collection, requiring development of data critical to existing chemical risk evaluation and risk management activities, and systematically collecting, reviewing, and synthesizing data for risk assessments in a transparent manner as mandated by the 2016 TSCA amendments;
• Conducting risk assessments for approximately 550 new chemical notices and exemption submissions and managing the identified risks associated with the chemicals;
• Continuing to implement a collaborative research program focused on developing new scientific approaches for performing risk assessments on new chemical substances;
• Reviewing and making determinations on CBI claims contained in TSCA submissions; making certain non-CBI available to stakeholders; and publishing identifiers for each chemical substance for which a confidentiality claim for specific chemical identity is approved; and
• Carrying out other required TSCA CRRR activities.

The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s proposed FY 2024 budget. A summary of the hearing will be available in our forthcoming memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Internal Revenue Service (IRS) announced on March 16, 2023, that it received a petition requesting that cellulose acetate (degree of substitution (DS) = 1.5-2.0) be added to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 16307. The petitioner is Celanese Ltd., an exporter of cellulose acetate (DS = 1.5-2.0). According to the notice, cellulose acetate (DS = 1.5-2.0) “is made from cellulose (wood pulp) and methane. The production process is a reaction of cellulose (from wood pulp) with acetic anhydride, normally using a solvent such as acetic acid and a strong acid such as sulfuric acid as a catalyst.” The petition covers cellulose acetate (DS = 1.5-2.0), “commonly referred to as cellulose diacetate. Cellulose acetate in this range generally has similar properties. The petition uses the lowest end of the range cellulose acetate DS = 1.5 to demonstrate that >20% of the substance is made from taxable chemicals, and the midpoint cellulose acetate DS = 1.75 to calculate the tax rate for the entire range.” Comments and requests for a public hearing are due May 15, 2023. More information on the Superfund excise tax on chemicals is available in our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need to Know to Comply,” and our May 19, 2022, memorandum, “Reinstated Superfund Excise Tax Imposed on Certain Chemical Substances.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The Senate Committee on Environment and Public Works will hold a hearing on March 22, 2023, on the proposed fiscal year (FY) 2024 budget for the U.S. Environmental Protection Agency (EPA). The only listed witness is EPA Administrator Michael Regan. As reported in our March 14, 2023, blog item, the budget requests over $12 billion in discretionary budget authority for EPA, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

• Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 9, 2023, President Biden released his fiscal year (FY) 2024 budget. According to the U.S. Environmental Protection Agency’s (EPA) March 9, 2023, press release, the budget requests over $12 billion in discretionary budget authority for EPA in FY 2024, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

• Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

EPA states that it will release the full Congressional Justification and Budget in Brief materials “soon.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on March 7, 2023, that EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 perfluorobutane sulfonic acid (PFBS) toxicity assessment. OIG conducted its evaluation to determine whether EPA followed applicable policies and procedures to develop and publish the PFBS toxicity assessment. OIG notes that two weeks after publication, EPA removed the toxicity assessment from its website, citing political interference and Scientific Integrity Policy violations. EPA republished the toxicity assessment in April 2021.
 
According to OIG, EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 toxicity assessment. OIG states that during final clearance, “a political appointee directed that a last-minute review be conducted of the uncertainty factors used to calculate toxicity values, resulting in a scientific disagreement that caused delay, confusion, and significant changes to the near-final, peer-reviewed work product.” The changes included replacing single toxicity values with “unprecedented toxicity ranges.” Users of the toxicity assessment, including regulated entities cleaning up PFBS contamination, “could have selected a less stringent value within this range, which may have been less costly but also less protective of human health.” While EPA staff expressed scientific integrity concerns about the last-minute review and risks to public health, EPA lacked policies and procedures to address these concerns. According to OIG, without updates to policies and procedures, EPA cannot fulfill its commitment to scientific integrity and information quality.
 
OIG made five recommendations:

• Three to the Assistant Administrator for Research and Development to reduce procedural confusion and strengthen existing policies, procedures, and guidance by clarifying if and when comments expressing scientific disagreement can be expressed; making clear if and when toxicity ranges are acceptable; and using OIG as a resource for high-profile scientific integrity concerns that relate to political interference or that assert risk to human health or the environment;
• One to the Assistant Administrator for Mission Support to update policies and procedures on environmental information quality to require additional quality assurance reviews for EPA products; and
• One to the Deputy Administrator to strengthen EPA’s culture of scientific integrity, transparency, and accountability of political leadership actions when changes occur as a result of policy decisions.

OIG notes that “EPA disagreed with all five recommendations, which remain unresolved.”

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 2, 2023, that the Office of Enforcement and Compliance Assurance (OECA) will hold two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA, it will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the extent that PFAS cleanup enforcement efforts occur under CERCLA.” EPA states that there will be opportunities to provide verbal input during the public listening sessions and written input submissions in a separate form.
 
The listening sessions will focus on an enforcement policy related to responsible parties’ financial obligations under PFAS contamination response actions. EPA notes that the sessions “will not focus on the actions needed to address PFAS contamination or EPA’s progress in the Agency’s PFAS Strategic Roadmap commitments.”
 
The sessions will be held:

• Tuesday, March 14, 2023, from 1:00 p.m. to 3:00 p.m. (EDT); and
• Thursday, March 23, 2023, from 10:00 a.m. to noon (EDT).

EPA states that its CERCLA PFAS enforcement discretion and settlement policy “is aimed at addressing stakeholder concerns and reducing uncertainties by clarifying when EPA intends to use its CERCLA enforcement authorities or its CERCLA enforcement discretion.” To the extent that PFAS cleanup enforcement efforts occur under CERCLA, EPA will develop a CERCLA PFAS enforcement discretion and settlement policy. According to EPA, the policy will take into account various factors, such as EPA’s intention to focus enforcement efforts on PFAS manufacturers and other industries whose actions result in the release of significant amounts of PFAS into the environment, and EPA’s intention not to focus on pursuing entities where factors do not support taking an enforcement action.
 
Registration is required to attend a listening session. The registration form provides the option for participants to make live verbal remarks or to listen. Information on the opportunity to speak at the session is provided on the registration form. Written comments related to the listening sessions are due March 31, 2023.
 
EPA notes that these listening sessions are separate from its perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) hazardous substance designation rulemaking process. The input provided through the listening sessions is not part of the rulemaking comment docket. The hazardous substance designation rulemaking comment period has closed.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 19, 2021, memorandum, the U.S. Environmental Protection Agency (EPA) published the PFAS Strategic Roadmap in October 2021, “laying out a whole-of-agency approach” to addressing per- and polyfluoroalkyl substances (PFAS). As part of the Roadmap, EPA committed to engage with communities in each EPA region to understand better their experiences and challenges in addressing PFAS contamination. To help inform EPA’s ongoing work under the Roadmap, EPA plans to facilitate a series of virtual community engagement sessions in 2023 for each of EPA’s ten regions. EPA states that it also plans to hold a session specifically designed to hear from its Tribal partners. The engagement sessions will provide opportunities for communities to share feedback directly with EPA regional and PFAS Council leaders to inform the implementation of the actions described in the Roadmap. Registration is now open for the following regional PFAS Community Engagement Sessions:

• February 28, 2023, at 6:00-8:00 p.m. (CST): Region 7 (Iowa, Kansas, Missouri, Nebraska, and nine Tribal Nations);
   
• March 2, 2023, at 6:00–8:00 p.m. (EST): Region 3 (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia, and seven federally recognized Tribes); and
   
• March 8, 2023, at 6:00–8:00 p.m. (MST): Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, and 28 Tribal Nations).

Registration for other regions will open soon. Stakeholders can sign up to be notified when registration for other regions is available. 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.
 
EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.
 
Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 74072. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due January 3, 2023.
 
According to EPA, during review of the PMNs submitted for the chemical substances that are the subject of the proposed SNURs, EPA concluded that regulation was warranted under TSCA Section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on its findings, EPA negotiated TSCA Section 5(e) Orders requiring the use of “appropriate exposure controls” with the PMN submitters. EPA states that as a general matter, it “believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors -- not just the original submitter -- are held to the same standard.” The proposed SNURs also include significant new uses that EPA proposes to determine are not ongoing based either on information showing that the chemical is not on the TSCA Inventory or based on EPA’s review of Chemical Data Reporting (CDR) submissions under TSCA Section 8(a). EPA states that it “believes that these uses could significantly increase the magnitude and duration of exposure to humans and the environment to these chemical substances. Accordingly, EPA wants the opportunity to evaluate and manage risks, where appropriate, from activities associated with those uses, before manufacturing or processing for those uses were to begin.”
 
EPA states that the SNURs advance one of the “key actions” in the PFAS Strategic Roadmap where EPA stated it plans to revisit past regulatory decisions concerning per- and polyfluoroalkyl substances (PFAS) and address those that are insufficiently protective by imposing additional notification requirements. According to EPA, in this way, it “can ensure it has the opportunity to review PFAS before they are used in new ways that might present concerns.” More information on the PFAS Strategic Roadmap is available in our October 19, 2021, memorandum.

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