By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including per- and polyfluoroalkyl substances (PFAS). GAO states that implementing the following three priority recommendations in this area, such as by establishing an ongoing process to assess the resources required to complete successfully Integrated Risk Information System (IRIS) chemical assessments, would improve EPA’s ability to prepare and issue the assessments:

• To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to reevaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in the report and ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database. According to GAO, as of February 2023, officials from ORD’s Chemical and Pollutant Assessment Division (CPAD) had conducted an analysis of the resources needed to produce chemical assessments, including IRIS assessments and Provisional Peer-Reviewed Toxicity Values. The analysis concluded by noting that CPAD is under-resourced and expects to experience a continued increase in its workload in coming years, thereby worsening the gap between what EPA offices need and what CPAD is able to produce. GAO states that CPAD’s analysis did not identify specific metrics for assessing the effectiveness of EPA’s staff recruitment and retention strategies or whether current resource allocations are helping CPAD meet the targets established in various EPA strategic action plans. GAO will keep the recommendation open until CPAD updates its analysis to include more specific metrics, which will help EPA determine the effectiveness of its recruitment and retention strategies.
   
• To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders. According to GAO, as of March 2023, EPA officials were considering ways to provide additional documentation to help stakeholders better understand the timeframes for completing IRIS assessments. GAO “encourage[s] EPA to provide its program offices with documentation of how long it takes to complete each of these different types of assessments to reduce uncertainty for stakeholders with significant interests in IRIS assessments.”
   
• The EPA Administrator should include in ORD’s strategic plan (or subsidiary strategic plans) identification of EPA’s universe of chemical assessment needs; how the IRIS program is being resourced to meet user needs; and specific implementation steps that indicate how IRIS will achieve the plan’s objectives, such as specific metrics to define progress in meeting user needs. GAO states that it will keep this recommendation open until CPAD updates its analysis to include such specific metrics and more information is available for GAO to determine the extent to which EPA management has used CPAD’s analysis to balance its workload with available resources. This would ensure EPA and CPAD can better identify and meet user needs.

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By Lynn L. Bergeson and Carla N. Hutton
 
According to a May 6, 2023, Canada Gazette notice, the Minister of the Environment, pursuant to the Canadian Environmental Protection Act, 1999 (CEPA), intends to unmask the identities of 132 substances currently on Part 3 of the Domestic Substances List (DSL) in accordance with the Approach to disclose confidential information and promote transparency in chemicals. The annexed proposed Order includes the masked names and confidential accession numbers of the substances proposed for unmasking. The notice states that any person who objects to the unmasking of a substance subject to the notice should submit a masked name application for each substance to the Substances Management Information Line, including a masked name that complies with the Masked Name Regulations and the justification outlined in Section 7.2.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).
 
The notice states that any person who conducts commercial activities with a substance that they believe to be subject to the notice of intent may provide the Chemical Abstracts Service Registry Number^® (CAS RN^®) to the New Substances program for confirmation. Any person who objects to the unmasking of a substance subject to this notice should submit a masked name application for each substance. Canada will take comments into consideration during the development of the final Order. Comments on the proposed Order are due July 5, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 3, 2023, the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing entitled “A Review of the President’s Fiscal Year 2024 Budget Request for the Environmental Protection Agency.” The only scheduled witness is Michael S. Regan, Administrator of the U.S. Environmental Protection Agency (EPA). On May 10, 2023, the House Energy and Commerce Subcommittee on the Environment, Manufacturing, and Critical Materials will hold a hearing on “The Fiscal Year 2024 Environmental Protection Agency Budget.” Regan is expected to be the only witness. As reported in our memoranda, both the Senate and House held hearings in March 2023 on EPA’s proposed fiscal year (FY) 2024 budget.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 27, 2023, the U.S. Environmental Protection Agency (EPA) announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. According to EPA, the Safer Choice program allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.
 
Similar achievement in the design, manufacture, selection, and use of Design for the Environment (DfE)-certified products will also make an organization eligible for the Partner of the Year Awards. The DfE program is a companion program to Safer Choice and certifies antimicrobial products. EPA states that the DfE logo may be used on certified products and helps consumers and commercial buyers identify products that meet the health and safety standards of the pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as the Safer Choice program’s stringent criteria for efficacy and effects on human health and the environment.
 
All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for the award should submit to EPA an application detailing their accomplishments and contributions during calendar year 2022. EPA “especially encourages submission of award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, improves drinking water quality, or advances innovation in packaging.” Submissions are due May 31, 2023. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2023. More information on the 2023 Safer Choice Partner of the Year Awards, including the application form, submission process, and past winners, is available on EPA’s website.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 28, 2022, that it awarded $748,180 in research grant funding to three institutions for research to improve understanding of how people are exposed to per- and poly-fluoroalkyl substances (PFAS) in several communities throughout the country. EPA states that there is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects. According to EPA, more data are needed to measure the nature and levels of PFAS in homes and food to understand pathways for human exposure and risk mitigation.
 
The following institutions are receiving awards:

• Silent Spring Institute, Newton, Massachusetts, to measure PFAS in air and dust in homes and to evaluate associations between potential residential sources and PFAS occurrence at home. According to EPA, this research will enhance understanding of the contribution of residential pathways to PFAS exposures and improve the interpretation of PFAS biomonitoring data;
   
• Duke University, Durham, North Carolina, to determine how different sources of PFAS exposure, including PFAS in drinking water and in homes, contribute to levels measured in blood. EPA states that this study will address key questions on the most relevant PFAS exposure pathways for the general U.S. population; and
   
• Emory University, Atlanta, Georgia, to develop a standardized, validated, scientific protocol to measure levels of a targeted set of PFAS in the home. According to EPA, data collected from home samples will be compared to data collected from PFAS in blood to help identify residential sources of PFAS measured in people’s blood.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of State (State Department) will hold a joint meeting from 2:00 p.m. to 3:30 p.m. (EDT) on September 22, 2022, to discuss United Nations Environment Assembly (UNEA) Resolution 5/8 and the related upcoming first session of the ad hoc open-ended working group (OEWG) on a science-policy panel (SPP) to contribute further to the sound management of chemicals and waste. In Resolution 5/8, UNEA states that an SPP should be established to contribute further to the sound management of chemicals and waste and to prevent pollution. UNEA further decided to convene, subject to the availability of resources, an OEWG to prepare proposals for the SPP, to begin work in 2022 with the ambition of completing it by the end of 2024. According to the resolution, the principal functions of the SPP should include:

• Undertaking “horizon scanning” to identify issues of relevance to policymakers and, where possible, proposing evidence-based options to address them;
• Conducting assessments of current issues and identifying potential evidence-based options to address, where possible, those issues, in particular those relevant to developing countries;
• Providing up-to-date and relevant information, identifying key gaps in scientific research, encouraging and supporting communication between scientists and policymakers, explaining and disseminating findings for different audiences, and raising public awareness; and
• Facilitating information sharing with countries, in particular developing countries seeking relevant scientific information.

The first session of the OEWG will be held in two parts, with the first part taking place on October 6, 2022, in a hybrid format, while the second part will be held in person in Bangkok early in the first quarter of 2023.
 
Industry and environmental non-governmental organization (NGO) stakeholders who would like to participate in the joint meeting on September 22, 2022, should .(JavaScript must be enabled to view this email address) by 10:00 a.m. (EDT) on September 22, 2022. This meeting is for U.S. stakeholders only and is not open to non-U.S. organizations, companies, or individuals.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
 
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
 
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.

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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
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.

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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.

WEBINAR
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
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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.

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