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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By Lynn L. Bergeson and Carla N. Hutton

On January 31, 2023, the U.S. Environmental Protection Agency (EPA) invited nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the EPA Science Advisory Board (SAB). 88 Fed. Reg. 6255. The SAB is a chartered Federal Advisory Committee (FAC) that provides independent scientific and technical peer review, consultation, advice, and recommendations to the EPA Administrator on the scientific bases for EPA’s actions and programs. The EPA Administrator appoints members for a two- or three-year term, and the members serve as Special Government Employees who provide independent expert advice to EPA. Nominations are due March 2, 2023.
 
According to the notice, members selected to the chartered SAB may also be asked to participate on the following standing committees of the SAB:

  • The Agricultural Science Committee, which provides advice on matters that have been determined to have a significant direct impact on farming and agriculture-related industries;
  • The Chemical Assessment Advisory Committee (CACC), which provides advice on EPA guidance documents, methodologies, and assessments that evaluate human health effects resulting from exposure to environmental hazards, as well as selected toxicological reviews of environmental chemicals available on EPA’s Integrated Risk Information System (IRIS);
  • The Climate Science Committee, which provides advice on climate change science and the effects of climate change;
  • The Drinking Water Committee, which provides advice on the scientific and technical aspects of EPA’s national drinking water program;
  • The Economic Analysis Committee, which provides advice on the economic analysis of EPA programs;
  • The Environmental Justice Science Committee, which provides advice on the scientific and technical aspects of environmental justice to improve the environment and/or public health in communities disproportionately impacted by environmental health hazards and risks; and
  • The Radiation Advisory Committee, which provides advice on radiation protection, radiation science, and radiation risk assessment.

The selection criteria for the SAB and the SAB committees include:

  • Demonstrated scientific credentials and disciplinary expertise in relevant fields;
  • Willingness to commit time to the committee and demonstrated ability to work constructively and effectively on committees;
  • Background and experiences that would help members contribute to the diversity of perspectives on the committee, e.g., geographical, social, cultural, educational backgrounds, professional affiliations; and other considerations; and
  • For the committee as a whole, the collective breadth and depth of scientific expertise are considered.
Tags: SAB, CACC

 
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Bergeson & Campbell, P.C.’s (B&C®) January 31, 2023, webinar “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C discussed the U.S. Environmental Protection Agency’s (EPA) priorities, leadership, and operating environment in the new year. This includes a review of priorities and challenges that will shape updates that are expected to affect Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) implementation in 2023.


 


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By Lynn L. Bergeson and Carla N. Hutton
 
The Federal Trade Commission (FTC) announced on January 31, 2023, that it has extended the deadline for public comment on its Guides for the Use of Environmental Marketing Claims (Green Guides) to April 24, 2023. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” FTC expects “many public comments” on the following specific issues:

  • Carbon Offsets and Climate Change: The current Green Guides provide guidance on carbon offset and renewable energy claims. FTC invites comments on whether the revised Green Guides should provide additional information on related claims and issues;
     
  • The Term “Recyclable”: Among other things, FTC seeks comments on whether it should change the current threshold that guides marketers on when they can make unqualified recyclable claims, as well as whether the Green Guides should address in more detail claims for products that are collected (picked up curbside) by recycling programs but not ultimately recycled;
     
  • The Term “Recycled Content”: FTC requests comments on whether unqualified claims about recycled content -- particularly claims related to “pre-consumer” and “post industrial” content -- are widely understood by consumers, as well as whether alternative methods of substantiating recycled content claims may be appropriate; and
     
  • The Need for Additional Guidance: FTC also seeks comment on the need for additional guidance regarding claims such as “compostable,” “degradable,” “ozone-friendly,” “organic,” and “sustainable,” as well as those regarding energy use and energy efficiency.

More information and an insightful commentary are available in our December 16, 2022, memorandum.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The Internal Revenue Service (IRS) announced on January 19, 2023, that it received a petition requesting the addition of 4,4′-isopropylidenediphenol-epichlorohydrin copolymer (bisphenol A epoxy resin) to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 3478. The petitioner is Westlake Epoxy Inc., an exporter of 4,4′-isopropylidenediphenol-epichlorohydrin copolymer. According to the petition, “4,4′-Isopropylidenediphenol-Epichlorohydrin Copolymer is a Bisphenol A Epoxy Resin and is used for Epoxide Resin. 4,4′-Isopropylidenediphenol-Epichlorohydrin Copolymer is derived from the taxable chemicals benzene, propylene, chlorine, and sodium hydroxide and produced predominantly from epichlorohydrin and bisphenol-A via a two-step glycidation reaction sequence. Taxable chemicals comprise 92.98 percent of the final product.” Comments and requests for a public hearing are due March 20, 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
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

  • A consistent definition of scientific integrity for all federal agencies;
  • A model scientific integrity policy to guide agencies as they build and update their policies; and
  • A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

  • Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
  • Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
  • Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
  • Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
  • Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
  • For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) fall 2022 Unified Agenda, published on January 4, 2023, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

  • Fees for the Administration of TSCA (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA fees rule (2021 Proposal). In light of public comments, EPA issued a supplemental notice of proposed rulemaking (SNPRM) on November 16, 2022. The SNPRM adds to and modifies the 2021 Proposal. EPA proposes to narrow certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposes exemptions for test rule fee activities; to modify the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; to institute a partial refund of fees for premanufacture notices (PMN) withdrawn at any time after the first ten business days during the assessment period of the chemical; to modify EPA’s proposed methodology for the production volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed; to expand the fee requirements to companies required to submit information for test orders; to modify the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements (ECA); to extend the timeframe for test order and test rule payments; and to change the fee amounts and the estimate of EPA’s total costs for administering TSCA Sections 4, 5, 6, and 14. More information on the SNPRM is available in our November 18, 2022, memorandum. EPA intends to issue a final rule in September 2023.
     
  • Updates to New Chemicals Regulations under TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Parts 720, 721, 723, and 725 to clarify and improve the efficiency of EPA’s review process and align its processes and procedures with the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). This rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve EPA’s processes for timely, effective completion of the risk assessment and of the new chemicals review. The rulemaking also seeks to improve EPA’s existing practices related to the review of certain groups of chemical substances under PMN exemptions. EPA intends to issue a notice of proposed rulemaking (NPRM) in July 2023 and a final rule in November 2024.
     
  • Chemical-Specific Rulemakings under TSCA Section 6(a): TSCA Section 6(a) requires EPA to eliminate unreasonable risks of injury to health or the environment that the Administrator has determined in a TSCA Section 6(b) risk evaluation are presented by a chemical substance under the conditions of use. After risk evaluations for the following chemicals carried out under the authority of TSCA Section 6, EPA will initiate rulemakings to address unreasonable risks of injury to health identified in the final risk evaluations:
     
    • Methylene Chloride (2070-AK70): EPA intends to issue an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for methylene chloride is available in our November 11, 2022, memorandum.
       
    • 1-Bromopropane (1-BP) (2070-AK73): EPA intends to issue an NPRM in September 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for 1-BP is available in our December 21, 2022, memorandum.
       
    • Carbon Tetrachloride (2070-AK82): EPA intends to issue an NPRM in May 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for carbon tetrachloride is available in our December 28, 2022, memorandum.
       
    • Trichloroethylene (TCE) (2070-AK83): EPA intends to issue an NPRM in June 2023 and a final rule in September 2024. More information on EPA’s final revision to its risk determination for TCE will be available in our forthcoming memorandum.
       
    • Perchloroethylene (PCE) (2070-AK84): EPA intends to issue an NPRM in April 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for PCE is available in our December 21, 2022, memorandum.
       
    • N-Methylpyrrolidone (NMP) (2070-AK85): EPA intends to publish an NPRM in September 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for NMP is available in our December 21, 2022, memorandum.
       
  • Procedures for Chemical Risk Evaluation under TSCA (2070-AK90): EPA states that it is considering revisions to its 2017 final rule that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. EPA intends to publish an NPRM in May 2023. More information on the 2017 final rule is available in our June 26, 2017, memorandum.
     
  • Revisions to Regulations on Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Subject to TSCA Section 6(h) (2070-AL02): EPA is considering revisions to the five PBT rules issued in January 2021 to reduce further exposures, promote environmental justice, and better protect human health and the environment. More information on the PBT rules is available in our December 23, 2020, memorandum. More information on EPA’s extension of the compliance dates for articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) is available in our March 7, 2022, memorandum. EPA intends to issue an NPRM in November 2023 and a final rule in September 2024.
     
  • Significant New Use Rules (SNUR) for Certain Non-Ongoing Uses: EPA states that it is authorized to designate a particular new use (or return of a phased-out use) of a chemical substance as a “significant new use” under TSCA Section 5(a)(2) by rule after consideration of relevant factors. EPA would use these rules to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. Persons subject to the SNUR who intend to manufacture (including import) or process the chemical substance for the significant new use must notify EPA at least 90 days prior to initiating activities via a significant new use notice (SNUN). EPA is developing TSCA Section 5(a)(2) SNURs on conditions of use identified as not currently ongoing in the final scope documents for the following High Priority Substances undergoing TSCA Section 6 risk evaluations:
     
    • Other Chemical Substances Undergoing TSCA Section 6 Risk Evaluation (2070-AL05): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Phthalates (2070-AL06): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Flame Retardants (2070-AL07): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Certain Solvents (2070-AL08): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
  • Per- and Polyfluoro Alkyl Substances (PFAS) Designated as Inactive on the TSCA Inventory; SNUR (2070-AL10): EPA is developing a SNUR under TSCA Section 5(a)(2) for certain uses of PFAS that are designated as Inactive on the TSCA Inventory. Although EPA intended to issue an NPRM in December 2022, it has not published anything to date. EPA plans to issue a final rule in December 2023.
     
  • Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting (2070-AK97): EPA is developing a proposal to add certain PFAS subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) to the list of Lower Thresholds for Chemicals of Special Concern (Chemicals of Special Concern). EPA states that the addition of the PFAS to the Chemicals of Special Concern list will eliminate the use of the de minimis exemption, eliminate the option to use Form A, and limit the use of range reporting. In addition, EPA proposes to eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list. More information on EPA’s December 5, 2022, NPRM is available in our December 7, 2022, memorandum. EPA intends to issue a final rule in November 2023.
     
  • Addition of Certain PFAS to the TRI (2070-AL03): EPA is developing a rulemaking to add certain PFAS to the list of chemicals reportable under EPCRA Section 313. The proposed addition of these PFAS is in direct response to a statutory mandate under Section 7321(d) of the National Defense Authorization Act for Fiscal Year 2020 (NDAA). Under Section 7321(d), EPA is required to evaluate whether certain PFAS meet the EPCRA Section 313 listing criteria by December 2021 and is required to add any PFAS that EPA determines meet the listing criteria by December 2023. EPA intends to issue an NPRM in May 2023 and a final rule in February 2024.

Final Rule Stage

  • TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for PFAS (2070-AK67): EPA published a proposed rule on June 28, 2021, addressing reporting and recordkeeping requirements for PFAS under TSCA Section 8(a)(7). In accordance with obligations under TSCA Section 8(a), as amended by NDAA Section 7351, persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. In November 2022, EPA solicited additional public comments on an Initial Regulatory Flexibility Analysis (IRFA) following the completion of a Small Business Advocacy Review (SBAR) Panel addressing the proposed PFAS reporting and recordkeeping requirements. EPA intends to issue a final rule in March 2023. More information on the 2021 proposed rule is available in our June 11, 2021, memorandum. More information on the IRFA is available in our November 29, 2022, memorandum.
     
  • Confidential Business Information (CBI) Claims under TSCA (2070-AK68): EPA is considering issuing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., CBI) under TSCA. The Lautenberg Act amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering issuing final procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering issuing final procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA intends to issue a final rule in February 2023. More information on EPA’s May 2022 NPRM is available in our May 17, 2022, and May 18, 2022, memoranda.
     
  • Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use under TSCA Section 6(a) (2070-AK86): On April 12, 2022, EPA proposed a rule under TSCA to address the unreasonable risk of injury to health for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, part 1: Chrysotile Asbestos. EPA proposed to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also proposed to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use and other chrysotile asbestos-containing gaskets for consumer use. Finally, EPA also proposed disposal and recordkeeping requirements for these conditions of use. EPA is reviewing the comments received and intends to develop a final rule. EPA intends to issue a final rule in October 2023. More information on EPA’s proposed rule is available in our April 7, 2022, memorandum.
     
  • Asbestos; Reporting and Recordkeeping Requirements under TSCA (2070-AK99): EPA states that this rulemaking, under the authority of TSCA Section 8(a), would require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) to report certain exposure-related information, including quantities of asbestos and asbestos-containing articles manufactured (including imported) or processed, types of asbestos use, and employee data. EPA and other federal agencies would use the reported information in considering the regulation of asbestos. EPA notes that this rulemaking is the result of a settlement agreement, stemming from litigation pursuant to TSCA Section 21. See Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. EPA intends to issue a final rule in May 2023. More information on EPA’s May 2022 NPRM is available in our May 6, 2022, memorandum.
     
  • Addition of Diisononyl Phthalate (DINP) Category; Community Right-to-Know Toxic Chemical Release Reporting (2025-AA17): On September 5, 2000, in response to a petition filed under EPCRA, EPA issued a proposed rule to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the PPA. EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that the category met the EPCRA toxicity criterion. According to EPA, the updated hazard assessment demonstrates that the proposed DINP category meets the EPCRA toxicity criterion because the members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans, specifically, developmental effects, kidney toxicity, and liver toxicity. On August 15, 2022, EPA proposed to add the DINP category to the toxic chemical list and requested comment on the updated DINP hazard assessment and associated updated economic analysis. EPA is considering the public comments received and next steps for this rulemaking. More information on the proposed rule is available in our August 10, 2022, blog item. EPA intends to issue a final rule in May 2023.
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 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA changed the status for one chemical (1-octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-) that has recently been identified on the SCIL as a per- or polyfluoroalkyl substance (PFAS). According to EPA, the chemical is not used in any Safer Choice-certified products. It was added to the SCIL in 2012 based on the data available and the state of EPA’s knowledge at the time. EPA has now updated the SCIL listing for this chemical to a grey square because of a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances. A grey square notation means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list this chemical on the SCIL. EPA will determine the data required on a case-by-case basis. According to EPA, in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA will remove the chemical from the SCIL 12 months after the grey square designation.
 
EPA states that after this update, there are 1,064 chemicals listed on the SCIL. The SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use this list to promote the safer chemicals they manufacture;
  • Retailers use the list to help shape their sustainability programs; and
  • Environmental and health advocates use the list to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 
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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 ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
  • Application-oriented use case demonstrations; and
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 
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Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST).

This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental Protection Agency (EPA) actions, particularly with respect to implementation of the 2016 amendments of the Toxic Substances Control Act (TSCA). Concepts core to the Act, including “reasonably foreseen,” “to the extent necessary,” “systematic review,” and “best available science,” continue to evolve and not always in predictable, coherent, and consistent ways. Similar policy shifts are seen in the agricultural and biocidal area, with perhaps less dramatic effect. How the 2024 general election will influence EPA’s policy choices is unclear. In that the election cycle has already begun, we caution all to buckle up and prepare for what we expect will be an eventful, fascinating year.
 
Register now to join Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®); James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C for this informative and forward-looking webinar.

Topics Covered:
  • TSCA in 2023
    • Final rules for mitigating risks identified in EPA risk assessments
    • Proposed rules for mitigating risks identified in EPA risk assessments
    • Risk evaluations -- assumptions and methods
    • Test orders to impose chemical testing requirements
    • New chemicals update on premanufacture notice (PMN) issues
  • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 2023
    • Congressional renewal of Pesticide Registration Improvement Act (PRIA) (registration fee program) for an additional five years
    • Endangered Species Act (ESA) program plans and progress
    • Program priorities for 2023, including environmental justice, registration review deadlines, staffing and budget, and possible 2023 Farm Bill actions
Speakers Include:

James V. Aidala, Senior Government Affairs Consultant with B&C, has been intimately involved with the TSCA and FIFRA legislative reauthorization and key regulatory matters for over four decades. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at EPA for pesticide and chemical regulation and provides clients with vital insights into not only relevant current policies of EPA and sister agencies, but also the way these policies have been or are likely to be formulated to help clients more successfully address regulatory matters.
 
Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.
 
Dennis R. Deziel, Senior Government Affairs Advisor with B&C, has an extraordinary depth of experience and knowledge of the regulatory process and government advocacy, honed through a career of senior leadership roles at EPA and the U.S. Department of Energy (DOE), among other significant positions. As Administrator of EPA Region 1, Mr. Deziel led the region’s 500-plus employees in managing energy, environment, and sustainability policy and programs, building coalitions across a wide range of stakeholders, including members of Congress, governors, federal and state government officials, industry, non-governmental organizations (NGO), and local communities.
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2023, the release of a new interactive web page on the “PFAS Analytic Tools” that provides information about per- and polyfluoroalkyl substances (PFAS) across the country. EPA states that this information will help the public, researchers, and other stakeholders better understand potential PFAS sources in their communities. According to EPA, the PFAS Analytic Tools draw from multiple national databases and reports to consolidate information on one web page. The PFAS Analytic Tools include information on Clean Water Act PFAS discharges from permitted sources; reported spills containing PFAS constituents; facilities historically manufacturing or importing PFAS; federally owned locations where PFAS are being investigated; transfers of PFAS-containing waste; PFAS detection in natural resources, such as fish or surface water; and drinking water testing results.

EPA notes that because the regulatory framework for PFAS is emerging, “data users should pay close attention to the caveats found within the site so that the completeness of the data sets is fully understood.” EPA states that rather than wait for complete national data to be available, it is publishing what is currently available while information continues to be filled in. Users should be aware that some of the data sets are complete at the national level, whereas others are not. For example, according to EPA, it included a national inventory for drinking water testing at larger public water utilities that was provided between 2013 and 2016. To include more recent data, EPA also compiled other drinking water data sets that are available online in select states. For the subset of states and tribes publishing PFAS testing results in drinking water, the percentage of public water supplies tested varied significantly from state to state. EPA cautions that because of the differences in testing and reporting across the country, the data should not be used for comparisons across cities, counties, or states.

EPA states that to improve the availability of the data in the future, it has published its fifth Safe Drinking Water Act Unregulated Contaminant Monitoring Rule to expand on the initial drinking water data reporting that was conducted from 2013 to 2016. According to EPA, this expansion will bring the number of drinking water PFAS samples collected by regulatory agencies into the millions. EPA notes that it also significantly expanded the Toxics Release Inventory (TRI) reporting requirements in recent years to over 175 PFAS and that more information should be received in 2023. EPA’s proposal to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances would also improve data on spill or release incidents reported to the Emergency Response Notification System. EPA will incorporate these reporting enhancements into future versions of the interactive web page.

EPA will hold a webinar to demonstrate the tools on Tuesday, January 10, 2023, at 1:00 p.m. (EST). Registration is open.

Tags: PFAS

 
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By Lynn L. Bergeson, Christopher R. Blunck, and Carla N. Hutton

On December 27, 2022, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed a lawsuit in the U.S. District Court for the District of Columbia to prevent Inhance Technologies USA from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. According to CEH and PEER’s joint press release, testing conducted by the U.S. Environmental Protection Agency (EPA), Notre Dame researchers, and other organizations “has found PFAS chemicals on the inner and outer surfaces of fluorinated containers and in the contents of the containers. The PFAS in the containers are likely formed as a result of chemical reactions that occur during the fluorination process conducted by Inhance.” According to the press release, Inhance “conducts fluorination operations at several facilities in the U.S. and is the leading supplier of post-mold fluorination services” in the United States. The press release notes that in 2020, EPA issued a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) barring firms from producing perfluorooctanoic acid (PFOA) and certain other PFAS until EPA had been notified and determined whether the proposed uses of these PFAS might present an unreasonable risk to health. The press release states that [‌i]n this event, the law required EPA to ban or restrict the PFAS for these uses.” According to the lawsuit, Inhance did not notify EPA in 2020 and has been subsequently manufacturing PFOA and other PFAS in violation of TSCA.

CEH and PEER seek a court order restraining Inhance from continued manufacture of PFAS in violation of the SNUR, “requiring it to stop all distribution of fluorinated containers in commerce until and unless TSCA requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to PFOA and other PFAS.”

The press release notes that on December 19, 2022, EPA filed suit against Inhance under TSCA. According to the press release, EPA’s suit “followed nearly two years of discussions between the agency and the company during which Inhance continued to produce PFAS in violation of TSCA without any EPA action to protect the public.” The press release states that EPA filed suit only after CEH and PEER wrote to the agency in late October 2022 “threatening to file suit against the company.” CEH and PEER intend to use their suit to ensure that EPA takes all actions authorized under TSCA “to put a stop to Inhance’s unlawful conduct and prevent unsafe exposure to PFAS by users of fluorinated containers.”

Commentary

This lawsuit raises many interesting issues. TSCA Section 20(b)(1)(B) appears to preclude commencement of a Section 20 action if EPA has commenced and “is diligently prosecuting a proceeding” to issue an order under TSCA Section 16 to require compliance. If the plaintiff has given appropriate notice of its pending action before EPA commences its action, it can, however, intervene in EPA’s action as a matter of right. A factual question relevant here is whether EPA is diligently prosecuting the proceeding. The plaintiff seems to address this issue in paragraph 35 of its complaint:

35. Because of the many redactions in the Complaint and the lengthy two-year delay between EPA’s initiation of discussions with Enhance [sic] and the filing of its suit, plaintiffs are concerned that EPA will not “diligently prosecute” its action in the Eastern District of Pennsylvania, removing a possible bar to plaintiffs’ suit in this Court under TSCA section 20(b)(1)(B) and enabling plaintiffs to seek all relief authorized by law in this action.

In that there have been relatively few TSCA Section 20 citizen actions to compel a person or company to come into TSCA compliance, this case could be one to watch. We question that the plaintiffs have made the case that EPA is not diligently prosecuting the case it filed, especially as only eight calendar days passed between the EPA filing and the plaintiffs’ filings, and that period included the Christmas holiday.

Another interesting issue relates to the likelihood that the manufacturing activities addressed in the complaint preceded proposal of the SNUR such that they would have been considered “ongoing,” thus arguably defeating application of the SNUR restrictions. Whether these activities preceded the proposed SNUR and whether EPA was made aware of this are unclear. Given the circumstances of the byproduct chemicals’ manufacture, it seems reasonable that such production would not be understood to be covered by the SNUR, as discussed further below -- and thus trigger the byproduct manufacturer to comment, noting to EPA the ongoing activity.

Notwithstanding EPA’s apparent position, it is questionable whether byproducts with no intentional use that become impurities in the products being processed and distributed are subject to SNURs. The manufacture of the substances of concern may be considered byproducts exempted by the SNUR. Although the byproduct exemption in Subpart A of Part 721 of the SNUR regulation itself, i.e., 40 C.F.R. Section 721.45(e), appears not to cover the activity, the PMN regulations exempt in 40 C.F.R. Section 720.30(h)(2) “[a]ny byproduct which is not used for commercial purposes.” This particular byproduct exemption appears to cover the byproducts in the facts at play, especially when read in the context of the chapeau to 40 C.F.R. Section 720.30(h) and 40 C.F.R. Section 721.1(c) of the SNUR regulations. which states:

The provisions of part 720 of this chapter apply to this part 721. For purposes of this part 721, wherever the phrase “new chemical substance” appears in part 720 of this chapter, it shall mean the chemical substance subject to this part 721. In the event of a conflict between the provisions of part 720 of this chapter and the provisions of this part 721, the provisions of this part 721 shall govern.

Arguably, there is no conflict between the SNUR regulation and the PMN regulations with regard to the applicability of the exemption at 40 C.F.R. Section 720.30(h)(2) to SNURs. In the absence of a provision making the exemption not applicable in specific SNURs, the exemption would appear applicable (as would other exemptions in 40 C.F.R. Section 720.30(h) that are not specifically replicated in 40 C.F.R. Section 721.45, certain of which we assume EPA even more clearly would not intend to include as covered manufacturing activities for SNUR purposes, e.g., a “chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article” (40 C.F.R. Section 720.30(h)(4)), which could also become an impurity in a product processed and distributed in commerce.). That the SNUR regulation exemptions duplicate certain PMN exemptions but exclude certain others should not be read to mean those excluded exemptions are not applicable given the language in 40 C.F.R. Section 721.1(c), copied above. Another view is that the manufacture of a substance as a byproduct that becomes an impurity in a product that is processed and distributed in commerce is not subject to the SNUR as the substance is not being manufactured “for any use” within the meaning of the SNUR. It is merely being inadvertently produced. Notwithstanding, we recognize EPA’s authority under TSCA to gather information, assess, and manage any unreasonable risks associated with the activity.

This is an interesting case TSCA mavens should monitor.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The Internal Revenue Service (IRS) announced on December 30, 2022, that it received a petition requesting the addition of polyphenylene sulfide to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 87 Fed. Reg. 80579. The petitioner is Celanese Ltd., an exporter of polyphenylene sulfide. According to the petition, “polyphenylene sulfide is a high-performance thermoplastic, has high heat and chemical resistance, and is used in applications such as filters, appliance, machine and automobile parts, replacing steel in some cases.” Polyphenylene sulfide is manufactured by the polymerization of 1,4-dichlorobenzene (p-DCB), a taxable substance, with sodium hydrosulfide and sodium hydroxide. Sodium hydrosulfide is made from sodium hydroxide and hydrogen sulfide. Taxable chemicals constitute 90.0 percent by weight of the materials used to produce this substance. Comments and requests for a public hearing are due February 28, 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
 
On December 29, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) published a report entitled The EPA’s Fiscal Years 2020 and 2019 Toxic Substances Control Act Service Fee Fund Financial Statements. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) requires EPA to prepare and OIG to audit the Toxic Substances Control Act (TSCA) Service Fee Fund financial statements each year. According to OIG, its primary objectives were to determine whether:

  • The financial statements were fairly stated in all material respects;
  • EPA’s internal controls over financial reporting were in place; and
  • EPA management complied with laws and regulations.

TSCA requires that the fees EPA charges be sufficient and not more than reasonably necessary to defray approximately 25 percent of the costs of administering specific sections of TSCA.
 
OIG rendered a “qualified opinion” on EPA’s fiscal years (FY) 2020 and 2019 TSCA Service Fee Fund financial statements, “meaning that, except for material errors in expenses and income from other appropriations, the fiscal years 2020 and 2019 financial statements were fairly presented.” OIG notes one material weakness, stating that “EPA materially understated the fiscal year 2019 ‘Expenses from Other Appropriations’ line item of the financial statements by nearly $25 million.” OIG did not identify any instances of noncompliance that would result in a material misstatement to the audited financial statements.
 
OIG notes that during its user fee analysis, it found that the TSCA fee structure in the fees rule during FYs 2020 and 2019 “appeared reasonable based on the data available when the EPA developed the fees rule.” The TSCA fees collected did not adequately offset the FYs 2020 and 2019 actual or projected costs of administering certain provisions of TSCA, however, “primarily because there were fewer fee-triggering activities than the EPA had projected for that period.”
 
OIG recommends that the chief financial officer correct the methodology for accounting for TSCA direct and indirect expenses from other appropriations to ensure that all costs for administering TSCA Sections 4 and 5, parts of Section 6, and Section 14 “are properly recorded and reported in the financial statements.” OIG states that EPA agreed with its recommendation and provided acceptable planned corrective actions. According to OIG, the recommendation is resolved with corrective actions pending.

Tags: OIG, Service Fee,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The Internal Revenue Service (IRS) announced on December 28, 2022, that it received a petition requesting the addition of polyoxymethylene to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 87 Fed. Reg. 79938. The petitioner is Celanese Ltd., an exporter of polyoxymethylene. According to the petition, “polyoxymethylene is an engineering thermoplastic used in precision parts requiring high stiffness, low friction, and excellent dimensional stability. It is widely used in the automotive and consumer electronics industry as well as many other high-performance uses.” Polyoxymethylene is made from methane and is manufactured through the polymerization of formaldehyde, and taxable chemicals constitute 50.0 percent by weight of the materials used to produce it. Comments and requests for a public hearing are due February 27, 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
 
On December 20, 2022, the Federal Trade Commission (FTC) requested public comment on its Guides for the Use of Environmental Claims (Green Guides). FTC intends the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. 87 Fed. Reg. 77766. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” As noted in our December 16, 2022, memorandum, publication of the notice in the Federal Register began a 60-day comment period. Comments are due February 21, 2023.
 
FTC states that it expects “many public comments” on the following specific issues:

  • Carbon Offsets and Climate Change: The current Green Guides provide guidance on carbon offset and renewable energy claims. FTC invites comments on whether the revised Green Guides should provide additional information on related claims and issues;
     
  • The Term “Recyclable”: Among other things, FTC seeks comments on whether it should change the current threshold that guides marketers on when they can make unqualified recyclable claims, as well as whether the Green Guides should address in more detail claims for products that are collected (picked up curbside) by recycling programs but not ultimately recycled;
     
  • The Term “Recycled Content”: FTC requests comments on whether unqualified claims about recycled content -- particularly claims related to “pre-consumer” and “post industrial” content -- are widely understood by consumers, as well as whether alternative methods of substantiating recycled content claims may be appropriate; and
     
  • The Need for Additional Guidance: FTC also seeks comment on the need for additional guidance regarding claims such as “compostable,” “degradable,” ozone-friendly,” “organic,” and “sustainable,” as well as those regarding energy use and energy efficiency.

More information and an insightful commentary are available in our December 16, 2022, memorandum.


 
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