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.
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April 3-5, 2023, Washington D.C.

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are proud to be sponsors of and presenting during the 2023 GlobalChem Conference. This three-day event offers authoritative speakers, in-depth sessions, and a chance to meet and reconnect with industry peers and key government representatives.
 
Highlights from the diverse and substantive program planned for GlobalChem attendees include:

  • New Chemicals Breakout Session -- In 2022, EPA initiated stakeholder outreach and a New Chemicals Collaborative Research Program to modernize new chemicals reviews and implement New Approach Methodologies (NAMs). This breakout offers perspectives and discussion on how these efforts are impacting new chemicals, currently and in the future. This session is hosted by Richard E. Engler, Ph.D., Director of Chemistry, B&C and Acta, on Tuesday, April 4, 2023.
     
  • CLP/GHS: Effects of New Hazard Classes and Implications for GHS -- A discussion of the U.S. update to GHS Revision 7 and an exploration of the new hazard classes the European Union (EU) has added to the CLP: endocrine disruptors; bioaccumulative, persistent, and toxic substances; and persistent, mobile, and toxic substances. Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, B&C and Acta, will present on Wednesday, April 5, 2023.

The full agenda is available online.
 
We hope to see you there, and at our booth in the exhibit hall (201), where you can pick up our latest regulatory updates and some useful tech gear. For more information and to register, visit the GlobalChem 2023 website.


 
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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.

Tags: DOE, EPA, Safer Choice,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 28, 2023, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). As reported in our March 22, 2023, blog item, EPA has posted the justification for its 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.

Our March 24, 2023, blog item provides details on resources requested for the Safer Choice, Environmentally Preferable Purchasing (EPP), and Green Chemistry Programs. As reported in our March 23, 2023, memorandum, the Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s FY 2024 budget request.


 
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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, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents (FTE) to support the P2 Program in the Environmental Program and Management (EPM) appropriation, an increase of $16 million and 18 FTEs above the FY 2023 enacted budget. The CJ states that FY 2024 funding will continue to support the following P2 programs.
 
Safer Choice Program
 
The CJ states that Safer Choice is a voluntary program that certifies safer products so consumers, businesses, and purchasers can find products that work well and contain ingredients safer for human health and the environment. EPA certifies and allows use of the Safer Choice label on products containing ingredients that meet stringent health and environmental criteria. Under the same stringent criteria, EPA certifies disinfectant products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) using the Design for the Environment logo. According to the CJ, the Safer Choice Program will expand into additional product categories and seek to increase consumer and commercial recognition of Safer Choice products. In FY 2024, EPA will continue its Partner of the Year Awards Program, recognizing organizations and companies for their leadership in formulating products made with safer ingredients and making them available to communities.
 
The CJ states that in FY 2024, Safer Choice will integrate and address environmental justice (EJ) concerns through outreach and partnership activities. Efforts to make Safer Choice-certified products more accessible to communities with EJ concerns will expand, with particular focus on low-income, Tribal, and indigenous populations and other vulnerable populations such as the elderly, children, and those with pre-existing medical conditions. According to the CJ, Safer Choice will work with retailers and product manufacturers to help them develop more products containing safer chemical ingredients that are easy to identify and purchase. Safer Choice will also work to empower custodial staff and house cleaning companies and enable facilities through education to gain access to Safer Choice-certified products to improve indoor air quality and reduce exposure-related asthma.
 
Environmentally Preferable Purchasing (EPP) Program
 
The EPP Program implements direction provided to EPA in several statutes and Executive Orders that mandate sustainable federal procurement, including through development and use of sustainability standards, specifications, and ecolabels. Beginning in FY 2023, the EPP Program is expanding the EPA Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing in new categories to support the Biden Administration’s environmental and human health goals and mandates, including net-zero emissions procurement, low embodied carbon construction materials, and products that do not contain per- and polyfluoroalkyl substances (PFAS). According to the CJ, the EPP Program has received applications for over 70 standards/ecolabels from 29 organizations to be considered for assessment and recommendation in federal purchasing. These cover the following high-impact federal procurement sectors: food and cafeteria services; uniforms/clothing; professional services; laboratories and healthcare; building/construction; infrastructure; and landscaping.
 
The CJ notes that EPA is characterizing PFAS provisions of existing private-sector sustainability standards, ecolabels, and certifications to identify products and purchase categories associated with key PFAS use and to prioritize PFAS conditions of use. In FY 2024, EPA will enhance public protection from potential effects of PFAS through recommendations of additional standards/ecolabels to help purchasers identify products that meet specific environmental performance criteria. EPA will conduct the following activities:

  • Assess and recommend additional ecolabels and standards with criteria specifically supporting reduction or elimination of PFAS use in key product categories not yet covered by the EPA Recommendations for Standards, Specifications, and Ecolabels for Federal Purchasing.
  • Build, implement, maintain, and update tools for integrating EPA recommendations into federal e-procurement systems, initiate identification and monitoring of relevant government contracts for sustainable purchasing requirements, and develop tools to ensure that PFAS data are captured for compliance in the Federal Procurement Data System (FPDS).
  • Initiate and engage in private-sector standards development activities that address product categories known to contain PFAS.
  • Work with the General Services Administration (GSA) and others to create a central product registry to identify products that meet EPA’s assessment of PFAS specifications.
  • Collaborate with the Department of Defense (DOD) on performance-based, rather than material-based, specifications and standards for equipment (e.g., textiles, coatings, firefighting foam) for DOD and Department of Homeland Security (DHS) uses.
  • Work with other federal agencies and the private sector to initiate a performance-based technology innovation challenge for a set of PFAS-free product categories for which use of non-PFAS options could be technically and economically feasible with respect to key federal purchasing categories.

According to the CJ, to support further EPA’s goals for equity and EJ, the EPP Program will begin to develop and implement training and outreach for disadvantaged communities, as well as state, Tribal, and local governments, to assist in facilitating product and service procurement choices that are environmentally sound and promote human and environmental health.
 
Green Chemistry Program
 
According to the CJ, the Green Chemistry Program fosters the sustainable design of chemical products and processes. It also analyzes green chemistry innovations and works with partners and external stakeholders to facilitate market adoption and penetration of new commercially successful chemistries and technologies. The CJ states that the program’s Green Chemistry Challenge Awards serve a critical role in raising the profile, importance, and credibility of innovative and market-ready green and sustainable chemistry technologies. In FY 2024, the Green Chemistry Program will begin to work with awardees and nominees to pursue the goal of market-oriented environmental and economic progress through increased adoption of these innovations. The CJ notes that EPA will support and lead portions of EPA’s responsibilities for implementation of the Sustainable Chemistry Research and Development Act of 2020. More information on the Sustainable Chemistry Research and Development Act of 2020 is available in our January 19, 2021, memorandum.


 
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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
 
The National Science and Technology Council announced on March 14, 2023, that the White House Office of Science and Technology Policy (OSTP) released a state of science report on per- and polyfluoroalkyl substances (PFAS). The report was prepared by the interagency PFAS Strategy Team created by OSTP at the direction of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021. It provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS:

  • Removal, destruction, or degradation of PFAS: This section details technologies used for removal, safe destruction, and degradation of PFAS in various environmental media (e.g., air, water), including benefits and limitations of existing technologies;
     
  • Safer and environmentally friendlier alternatives: This section highlights ongoing activities around the development of safer and more environmentally friendly alternatives that are functionally similar to those made with PFAS. Specific challenges highlighted include firefighting foams, industrial uses, food packaging and contact materials, pesticides, textiles, recreation products, cosmetics and personal care products, pharmaceuticals, and medical devices. An important consideration to advancing this area of research and development is identifying critical uses of PFAS;
     
  • Sources and pathways of exposure: PFAS sources, releases, fate and transport considerations, and potential pathways of exposure, such as exposure media and routes, are detailed. Mitigation efforts and health-protective measures cannot be implemented without the ability to detect PFAS at levels of concern. Addressing the challenge of developing additional analytical methods with higher sensitivity to detect both single PFAS and mixtures of PFAS is a critical opportunity to accelerate advancement across all other areas; and
     
  • Toxicity: PFAS toxicity information is informed by laboratory animal data, ecological data, human health data, and predictive modeling information. To leverage fully the understanding of PFAS toxicity, a weight-of-evidence approach that takes into account the different evidence streams is needed. Because of the large number of PFAS currently identified in commerce, one goal of future research is to determine whether all PFAS, or specific groups, might pose a similar hazard to human and ecological receptors. The report notes that such PFAS groupings may provide a means by which agencies might regulate PFAS for the protection of humans and ecological receptors.

The report identifies data gaps within each strategic area to provide a roadmap for research and development (R&D) activities that, when addressed, will generate actionable information to guide federal agencies and PFAS collaborators and partners. Over the next year, the PFAS Strategy Team will operationalize a strategic plan and implementation framework that organizes and coordinates activities in these strategic areas by harnessing existing research and accelerating transformative advancements. The report states that information generated will inform PFAS advisories, disposal approaches, and development of PFAS alternatives, and fuel other innovative public health actions.

Tags: OSTP, PFAS

 
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 By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of $16 million for two new grant opportunities to support states and Tribes in providing technical assistance to businesses seeking to develop and adopt pollution prevention (P2) practices that advance environmental justice in underserved communities. The Request for Applications for P2 investments include the Pollution Prevention Grant: Environmental Justice Through Safer and More Sustainable Products. The goal of this grant is to address environmental justice by providing P2 technical assistance to businesses (e.g., information, training, expert advice) to improve human health and the environment in disadvantaged communities by increasing the supply, demand, and use of safer and more sustainable products, such as those that are certified by EPA’s Safer Choice Program, or those that conform to EPA’s Recommendations for Specifications, Standards and Ecolabels for Federal Purchasing (EPA Recommendations).
 
To allow a greater number of disadvantaged communities to benefit from the results and lessons learned from projects funded by these grants, EPA states that it is requiring recipients to develop P2 case studies on approaches to make safer and sustainable products more available in disadvantaged communities where the approaches are new, not widely known or adopted, or where the recipient believes detailed information on the project could support more widespread project replication. Recipients must develop at least one case study during the grant period. According to EPA, it will use these case studies to build and share a body of knowledge about P2 approaches to make safer and sustainable products more available in disadvantaged communities that could be implemented by other enterprises.
 
Eligible entities include the 50 states, the District of Columbia, the U.S. Virgin Islands, the Commonwealth of Puerto Rico, any territory or possession of the United States, any agency or instrumentality of a state or Tribe, including colleges and universities, and federally recognized Tribes and intertribal consortia. EPA “strongly” encourages applicants to develop partnerships where they can strengthen their ability to provide P2 technical assistance to businesses in disadvantaged communities.
 
EPA will hold informational webinars on March 21, March 23, March 28, and March 30, 2023. Although EPA’s press release states that applications for the grant are due June 6, 2023, the information on grants.gov states that the closing date for applications is June 20, 2023.


 
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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.”

Tags: PFAS, budget

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second of its two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). The webinar, which will be held March 30, 2023, will give an in-depth look into the standardized risk assessment approach and present various case scenarios and a decision tree for identifying potential hazards and risks. The kickoff webinar, held in November 2022, provided a broad overview of the approach and answered stakeholder questions. A summary of the first webinar is available in our November 23, 2022, memorandum.
 
Under the Toxic Substances Control Act (TSCA), EPA reviews all new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment. As reported in our October 11, 2022, memorandum, EPA announced an innovative effort to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs have many electrical applications in batteries and uses as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, making them a vital part of clean energy sectors.


 
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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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Washington D.C. law firm Bergeson & Campbell, P.C. (B&C®) has launched the PFAS News and Information web page. Continuing B&C’s tradition of providing reliable information and analysis of the most pressing chemical issues of the day, this web page provides constantly updated resources to help those in the chemicals and chemical products industries understand what they need to know about per- and polyfluoroalkyl substances (PFAS) developments and what it means to their business.
 
PFAS regulation is as globally ubiquitous as the very class of chemicals the term “PFAS” is defined to include, and the pace will only accelerate. Stakeholders need to know what is in play to stay ahead of these actions and stay in compliance.
 
B&C’s lawyers, scientists, regulatory specialists, and business consultants relentlessly participate in and track developments regarding the global regulatory approach to PFAS and are pleased to offer this rich library of PFAS resources to the chemical stakeholder community.
 
B&C’s PFAS News and Information site is at www.lawbc.com/pfas-resource-center.
 
Registration is now open for B&C’s upcoming webinar, PFAS Reporting, PBTs, and Other TSCA Hot Topics, to be held on May 17, 2023, 11:00 a.m. – 12:00 p.m. (EDT), via webinar.
 
Resources currently featured on the PFAS News and Information page include:

Bergeson & Campbell, P.C. is a Washington D.C. law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. 
 
B&C’s Toxic Substances Control Act (TSCA) practice group includes seven former senior U.S. Environmental Protection Agency (EPA) officials, an extensive scientific staff, including six Ph.D.s, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well-versed in all aspects of TSCA law, regulation, policy, and litigation. B&C is publisher of the TSCAblog®, featuring news and analysis regarding TSCA implementation and related legal and administrative developments.

Tags: PFAS, Resource

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency opened a 30-day comment period on nominations for candidates to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). According to EPA, there are currently 17 SACC members, with eight membership terms that will soon expire. Biographies for all candidates under consideration are available online. In addition, biographies for current SACC members are available on the SACC website. Comments on the nominations are due April 7, 2023. EPA states that it will use comments received to assist it in selecting new members of the SACC by June 2023.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

Tags: TSCA, SACC, OCSPP

 
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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:

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.

Tags: CERCLA, OECA, PFAS

 
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