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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management under TSCA (2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in the Risk Evaluation/Risk Management (RE/RM) Lifecycle and update the reporting requirements under the 40 C.F.R. Part 711 Chemical Data Reporting (CDR) regulation. Specifically, EPA is seeking occupational, environmental, and consumer exposure information. EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. According to the Unified Agenda item, EPA needs this information to inform prioritization, risk evaluation, and risk management of chemical substances under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in May 2023 and a final rule in September 2024. More information on EPA’s July 27, 2021, webinar on development of the proposed rule is available in our July 29, 2021, memorandum.
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA fees rule. EPA proposed modifications to the TSCA fees and fee categories for fiscal years (FY) 2022, 2023, and 2024 and explained the methodology by which the proposed TSCA fees were determined. EPA proposed to add three new fee categories: A Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee-triggering activities, including an exemption for research and development (R&D) activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA updated its cost estimates for administering TSCA, relevant information management activities, and individual fee calculation methodologies. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and is proposing to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA also proposed various changes to the timing of certain activities required throughout the fee payment process. In light of public comments, EPA states that it has decided to issue a supplemental NPRM in October 2022 and seek additional public comment on changes to the January 2021 proposal. More information on the proposed rule is available in our December 30, 2020, memorandum.
  • New Chemicals Procedural Regulations to Reflect the 2016 Amendments to TSCA (2070-AK65): On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) was signed into law, amending TSCA and impacting how EPA reviews and makes determinations on new chemical notices under TSCA Section 5. EPA states that as a result of these increased responsibilities, it has become more challenging to complete reviews within 90 days. This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. This rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve EPA’s processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review. EPA intends to publish an NPRM in February 2023.
  • Confidential Business Information (CBI) Claims under TSCA (2070-AK68): EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of CBI under TSCA. Amendments to TSCA in 2016 included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA states that it is considering 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 whether the proposed rule should also elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments to TSCA. As reported in our May 17 and May 18, 2022, memoranda, EPA issued a proposed rule on May 12, 2022. EPA intends to issue a final rule in May 2023.
  • Chemical-Specific Rulemakings under TSCA Section 6(a): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following risk evaluations for the following chemicals carried out under the authority of TSCA Section 6, EPA initiated rulemakings to address unreasonable risks of injury to health identified in the final risk evaluations:
    • Methylene Chloride (2070-AK70): EPA’s risk evaluation for methylene chloride, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0437, with additional information in docket EPA-HQ-OPPT-2016-0742. EPA intends to issue an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for methylene chloride will be available in a forthcoming memorandum;
    • 1-Bromopropane (2070-AK73): EPA’s risk evaluation for 1-bromopropane, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0235, with additional information in docket EPA-HQ-OPPT-2016-0741. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024;
    • Carbon Tetrachloride (2070-AK82): EPA’s risk evaluation, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0499, with additional information in docket EPA-HQ-OPPT-2016-0733. EPA intends to publish an NPRM in April 2023 and a final rule in August 2024;
    • Trichloroethylene (TCE) (2070-AK83): EPA’s risk evaluation for TCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0500, with additional information in docket EPA-HQ-OPPT-2016-0737. EPA intends to publish an NPRM in March 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for TCE will be available in a forthcoming memorandum;
    • Perchloroethylene (PCE) (2070-AK84): EPA’s risk evaluation for PCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0502, with additional information in docket EPA-HQ-OPPT-2016-0732. EPA intends to publish an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for PCE will be available in a forthcoming memorandum;
    • N-Methylpyrrolidone (NMP) (2070-AK85): EPA’s risk evaluation for NMP, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0236, with additional information in docket EPA-HQ-OPPT-2016-0743. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for NMP will be available in a forthcoming memorandum; and
    • Asbestos (Part 1: Chrysotile Asbestos) (2070-AK86): EPA’s risk evaluation for chrysotile asbestos, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0501, with additional information in docket EPA-HQ-OPPT-2016-0736. More information on EPA’s proposed rule to prohibit ongoing uses of chrysotile asbestos is available in our April 7, 2022, memorandum. EPA intends to publish a final rule in November 2023.
  • Procedures for Chemical Risk Evaluation under TSCA (2070-AK90): As required under TSCA Section 6(b)(4), EPA published a final rule on July 20, 2017, 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. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now considering revisions to that final rule and will solicit public comment through an NPRM. EPA intends to publish the NPRM in September 2022. More information on EPA’s 2017 rule is available in our June 26, 2017, memorandum.
  • Asbestos; Reporting and Recordkeeping Requirements under TSCA (2070-AK99): 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 used, and employee data. Reported information would be used by EPA and other federal agencies 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. More information on EPA’s proposed reporting and recordkeeping requirements is available in our May 6, 2022, memorandum. EPA intends to publish a final rule in November 2022.
  • Other Chemical Substances Undergoing TSCA Section 6 Risk Evaluation; Significant New Use Rule (SNUR) for Certain Non-Ongoing Uses (2070-AL05): 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 high-priority substances undergoing TSCA Section 6 risk evaluations. EPA states that it will use the SNURs to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. Persons subject to a 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 intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • The Unified Agenda includes the following chemical-specific SNURs for certain non-ongoing uses:
    • Phthalates; SNUR for Certain Non-Ongoing Uses (2070-AL06): EPA intends to publish an NPRM in November 2022 and a final rule in May 2024;
    • Flame Retardants; SNUR for Certain Non-Ongoing Uses (2070-AL07): EPA intends to publish an NPRM in December 2022 and a final rule in November 2023; and
    • Certain Solvents; SNUR for Certain Non-Ongoing Uses (2070-AL08): EPA intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • Inactive Inventory Per- and Polyfluoroalkyl Substances (PFAS) SNUR (2070-AL10): EPA is developing a SNUR under TSCA Section 5(a)(2) for certain uses of Inactive Inventory PFAS. Persons subject to the Inactive Inventory PFAS SNUR would be required to notify EPA at least 90 days before commencing manufacture or processing for any use that EPA has determined is a significant new use. The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA intends to publish an NPRM in September 2022 and a final rule in June 2023.
  • TRI; Response to Petition to Add Diisononyl Phthalate (DINP) to the TRI List of Toxic Chemicals (2025-AA17): According to EPA, this action arises from a petition received by EPA to add DINP to the list of toxic chemicals reportable under Section 313 of the Emergency Planning and Community Right to Know Act (EPCRA). In response to the petition, EPA initiated a rulemaking on September 5, 2000, proposing to add DINP to the TRI list. On June 14, 2005, EPA issued a notice of data availability seeking comments on EPA’s revised hazard assessment for DINP in further support of EPA’s proposal to add DINP to the TRI list. EPA states that the addition of DINP to the TRI list would make it subject to all the reporting requirements under the Toxic Chemical Release Reporting Rule. EPA intends to publish a supplemental NPRM in July 2022 and a final rule in May 2023;
  • Changes to Reporting Requirements for PFAS; Community Right-to-Know Toxic Chemical Release Reporting (2070-AK97): EPA is developing a proposal to add PFAS subject to reporting under EPCRA Section 313 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 is proposing 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. According to EPA, Chemicals of Special Concern may be found in products below de minimis levels; this is especially true for PFAS that are used at low concentrations in many products. Because of the widespread use of PFAS and their (or their degradants) persistence in the environment, however, even concentrations below de minimis levels can contribute significantly to environmental loading. The elimination of the de minimis exemption for supplier notification purposes will help facilities to identify potential sources of PFAS and other Chemicals of Special Concern. EPA believes that the elimination of the de minimis exemption under the Supplier Notification Requirements for PFAS and other Chemicals of Special Concern will result in a more complete picture of the releases and waste management quantities for these chemicals. EPA intends to publish an NPRM in September 2022 and 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. EPA states that the 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 was required to evaluate whether certain specific 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 publish an NPRM in February 2023 and a final rule in November 2023.
  • Community Right-to-Know; Adopting 2022 North American Industry Classification System (NAICS) Codes for TRI Reporting (2070-AL09): EPA is developing a proposed rule to incorporate the revised 2022 North American Industry Classification System (NAICS) codes for TRI reporting purposes. According to EPA, the Office of Management and Budget (OMB) updates the NAICS codes every five years. OMB approved the 2022 NAICS codes on December 21, 2021 (86 Fed. Reg. 72277), with an effective date of January 1, 2022. EPA currently uses 2017 NAICS codes, and with this proposed rule would implement the 2022 codes for TRI Reporting Year 2022. Facilities reporting to the TRI would be required to use 2022 NAICS codes on reports that are due to EPA by July 1, 2023. This rule also proposed to update the C.F.R. to clarify the scope of facilities required to report to the TRI. According to EPA, the actual data required by a TRI form would not change as a result of this rulemaking, nor would the rule affect the universe of TRI reporting facilities that are required to submit reports to EPA under EPCRA Section 313. EPA intended to publish an NPRM in June 2022 and a final rule in November 2022.

Final Rule Stage

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): In 2016, EPA proposed changes to the existing regulations governing significant new uses of chemical substances under TSCA (40 C.F.R. Part 721, specifically “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72)) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) (29 C.F.R. Section 1910.1200), which are proposed to be cross referenced, and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA also proposed changes to the significant new uses of chemical substance regulations based on issues that have been identified by EPA and issues raised by public commenters for SNURs previously proposed and issued under these regulations. Additionally, EPA proposed a minor change to reporting requirements for PMNs and other TSCA Section 5 notices. EPA states that it expects these changes to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in October 2022. More information on the proposed rule is available in our July 29, 2016, memorandum.
  • Reporting and Recordkeeping for PFAS under TSCA Section 8(a)(7) (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 addition to fulfilling statutory obligations under TSCA, EPA states that it expects that the proposed rule would enable it to characterize better the sources and quantities of manufactured PFAS in the United States. EPA intends to publish a final rule in December 2022. More information on EPA’s proposed rule is available in our June 11, 2021, memorandum.
  • TRI; Response to Petition from the Toxics Use Reduction Institute (TURI) to Add 25 Chemicals (2070-AK26): The Toxics Use Reduction Institute (TURI) submitted a petition under EPCRA Section 313(e)(1) to add 25 chemicals to the EPCRA Section 313 list of toxic chemicals subject to reporting under the TRI. Three of the 25 chemicals were added to the EPCRA Section 313 list through actions unrelated to the petition. EPA states that it evaluated the remaining 22 chemicals to determine if they met the listing criteria of EPCRA Section 313(d)(2). EPA proposed the addition of 12 of the 22 chemicals that were determined to meet the EPCRA Section 313(d)(2) criteria and for which reports were expected to be filed. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in November 2022.
  • Parent Company Definition for TRI Reporting (2070-AK42): In 2021, EPA proposed to codify the definition of “parent company” for purposes of reporting to the TRI. Although the existing regulation requires facilities reporting to the TRI to identify their parent company in annual reporting forms, no codified definition of this data element exists. Among the facilities reporting to the TRI are those with complicated corporate ownership structures. As such, effort is required each year by reporting facilities and EPA to clarify how the parent company data element should be represented on the form. According to EPA, a codified definition of parent company would allow EPA to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. EPA states that the proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving EPA’s data quality. EPA is reviewing the comments received and is determining next steps. EPA intends to publish a final rule in October 2022.
  • NDAA Mandated Addition of Certain PFAS to the TRI for Reporting Year 2022 (2070-AL04): According to EPA, NDAA Section 7321 provides a framework for PFAS to be added automatically to the TRI list on January 1 of the year following certain EPA actions. In December 2021, EPA announced the statutory addition of the PFAS chemicals covered by the NDAA to the list of chemical substances subject to reporting for the TRI. This regulatory action amends the EPCRA regulations in 40 C.F.R. Part 372 to reflect this statutory addition. EPA intended to publish a final rule in June 2022.

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has published the draft fiscal year (FY) 2023-2024 National Program Guidances (NPG) for public comment. The NPGs set forth the strategies and actions EPA and its state and Tribal partners intend to undertake to protect human health and the environment. The draft FY 2023-2024 NPGs include an NPG for the Office of Chemical Safety and Pollution Prevention (OCSPP). Work in this NPG directly supports Goal 7, “Ensure Safety of Chemicals for People and the Environment,” in EPA’s FY 2022 - 2026 EPA Strategic Plan. OCSPP’s draft NPG also integrates the Strategic Plan’s goal to tackle climate change, advance environmental justice and civil rights, and consider the health of children and other vulnerable populations in implementing its programs. OCSPP’s program priorities include:

  • Pesticide Cooperative Agreements with States and Tribes;
  • Pollinator Protection Efforts;
  • Revised Pesticide Worker Protection Standard Rule;
  • Revised Certification of Pesticide Applicators Rule;
  • Region-Specific Pesticide Priorities on Those Areas of Greatest Need Nationally;
  • Toxics Release Inventory (TRI);
  • Lead Risk Reduction; and
  • Pollution Prevention (P2).

For each priority, the draft NPG includes a description, strategy, activities, and measures. The draft NPG also includes sections on implementing Tribal work; flexibility and grant planning; federal civil rights responsibilities, including Title VI of the Civil Rights Act of 1964; and FY 2023-2024 National Program Measures. Comments on the draft NPGs are due July 14, 2022.

Tags: NPG, OCSPP, P2, TRI

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2021, that it is expanding the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. EPA states that under the Emergency Planning and Community Right-to-Know Act (EPCRA), “the EPA Administrator has the discretionary authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of releases of the chemical at the facility, or other factors the Administrator deems appropriate.” According to EPA, exposure to ethylene oxide can cause cancer in humans and damage DNA. Other effects include eye, skin, nose, throat, and lung irritation, as well as harm to the brain and nervous system. Workers in facilities that use ethylene oxide and people in communities located adjacent to these facilities, including historically underserved communities, have the highest chance of being exposed to ethylene oxide. EPA notes that because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by ethylene oxide.
 
In October 2021, EPA sent letters to 31 facilities providing notice that EPA was considering exercising its discretionary authority. After corresponding with many of the facilities, EPA has issued a determination extending TRI reporting requirements to 29 of the 31 facilities for ethylene oxide and to 16 of the 31 facilities for ethylene glycol. According to EPA, because ethylene glycol is produced using ethylene oxide, these chemicals may co-occur at facilities. EPA states that it believes these 29 contract sterilization facilities, which do not currently report to TRI, use the highest amounts of ethylene oxide in the contract sterilization sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for ethylene oxide. EPA notes that it considered additional factors, such as the facilities’ proximity to a population center (e.g., the number of people, including children under the age of five living near the facilities), their history of releases of ethylene oxide and ethylene glycol (e.g., past receipt of TRI reporting forms on ethylene oxide and ethylene glycol from these facilities), and other factors the Administrator deemed appropriate (e.g., proximity of the facilities to nearby schools and communities, especially those with potential environmental justice concerns and concerns for facility workers).
 
EPA did not to extend TRI reporting requirements to two of the 31 facilities initially contacted. According to EPA, one of the facilities conveyed to EPA that they had sold the establishment they previously used for sterilization and no longer perform sterilization work at that facility. Another facility informed EPA that their facility uses ethylene oxide in quantities far below the amount that would trigger TRI reporting in a year due to their sterilization technology and scale of operations.
 
Beginning in January 2022, these 29 facilities should start tracking their activities involving ethylene oxide (and ethylene glycol, if applicable) releases and other waste management quantities as required by EPCRA, similar to any other facility subject to TRI reporting requirements. If reporting thresholds are met, the facilities must submit TRI data beginning in 2023.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 27, 2021, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA Toxic Substances Control Act (TSCA) Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86 Fed. Reg. 59382. EPA states that individuals nominated should have expertise in one or more of the following areas:

  • Systematic review: Individuals nominated for peer review of the draft systematic review protocol should have expertise in one or more of the following areas: systematic review approaches of human health and ecological hazard, exposure topics, and fate. All experts, including those representing other fields of interest, who have experience with engineering, machine learning, artificial intelligence techniques, and natural language processing approaches as applied to systematic review are also needed. EPA states that understanding the TSCA risk evaluation process “is highly desirable for the context of this peer review.”
  • Exposures to fenceline communities: Individuals nominated for peer review of the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities should have expertise in one or more of the following areas: chemical fate and transport via ambient air and water pathways; atmospheric modeling of fate, transport, and human exposures; human health, exposure, and risk assessment for airborne and/or waterborne chemicals; expertise estimating environmental air releases of chemicals from a variety of sources and databases such as Chemical Data Reporting (CDR); experience developing air dispersion methodologies and/or models to estimate ambient air concentrations and impacts to human populations; expertise estimating environmental water releases of chemicals from a variety of sources and databases such as CDR, Toxics Release Inventory (TRI), and Discharge Monitoring Report; experience developing methodologies and/or models to estimate chemical concentrations in ambient/source/drinking water and impacts to human populations; and public health protection for at-risk communities.

EPA states that any interested person or organization may nominate qualified individuals to be considered prospective candidates for these reviews. Individuals may also self-nominate. Nominations are due November 17, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a proposed rule on September 28, 2021, that would codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI). 86 Fed. Reg. 53577. Although the existing regulation requires a facility reporting to TRI to identify its parent company in annual reporting forms, no codified definition of this data element exists. EPA states that a codified definition of parent company would allow it to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. The proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving data quality. The proposed rule addresses the following ownership scenarios:

  • A facility is owned by a single company that is not owned by another company;
  • A facility is owned by a single company that is owned by another company;
  • A facility is owned by multiple companies, including companies that are themselves owned by other entities;
  • A facility is owned by a joint venture or cooperative;
  • A facility is owned, at least in part, by a foreign company; and
  • A facility is owned by the federal government, or a state, tribal, or municipal government.

EPA also proposes to require facilities reporting to TRI to use standardized naming conventions for parent company reporting, as provided in the annual TRI Reporting Forms and Instructions (RFI), available as a downloadable Excel file (“Standardized Parent Company Names”) at http://www.epa.gov/tri/rfi. EPA states that these naming conventions address common formatting discrepancies, such as punctuation, capitalization, and abbreviations (for example, “Corp” for “Corporation”). Comments are due November 29, 2021. According to the notice, under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of comments by October 28, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 24, 2021, for stakeholders to learn how to access and use the pollution prevention (P2) information collected by the Toxics Release Inventory (TRI) Program about projects implemented by companies to eliminate or reduce the creation of chemical waste. According to EPA, community members, local government representatives, facility personnel, and others can access this information through multiple online resources and use it to further the identification and advancement of P2 opportunities. The webinar will include a live demonstration of how to find P2 data for specific facilities, chemicals, and industry sectors, as well as:

  • Details on what data facilities are required to report;
  • Examples of P2 projects implemented at manufacturing facilities; and
  • Resources for and benefits of implementing P2 projects at facilities.

The webinar is also part of a series of webinars to mark the 35th anniversary of the TRI Program. Registration is now open.


 

WEBINAR
Thursday, September 9, 2021
11:00 a.m. – 12:00 p.m. (EDT)
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Bergeson & Campbell, P.C. (B&C®) is pleased to present a complimentary webinar focused on the U.S. Environmental Protection Agency’s (EPA) proposed per- and polyfluoroalkyl substances (PFAS) regulations on September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT). B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., will discuss three actions recently taken by EPA:

  • Proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States;
  • Withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS; and
  • Publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).

The proposed rule intended to obtain comprehensive data on PFAS would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.
 
As a result of these EPA regulatory actions, companies that never expected to need to know the Toxic Substances Control Act (TSCA) are now finding themselves in EPA’s crosshairs. This webinar will explore the full scope of these potential rules, how entities can determine if they will be subject to reporting, and the specific recordkeeping requirements that have been proposed.

Register for the webinar now
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 29, 2021, the availability of the preliminary Toxics Release Inventory (TRI) data on chemical releases, chemical waste management, and pollution prevention activities that took place during 2020 at almost 21,000 federal and industrial facilities in the United States. EPA notes that the preliminary data include the first-ever reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA). The dataset is raw data and does not contain any summary or trend analysis. EPA plans to publish the updated TRI dataset in Fall 2021, and EPA will use it to develop the 2020 TRI National Analysis. EPA expects to publish the 2020 TRI National Analysis in early 2022. According to EPA, the public can use the preliminary data to identify facilities that report to TRI (for example, to locate facilities in a given ZIP code) and learn which chemicals facilities manage and in what quantities.

PFAS-Related Information from the 2020 Preliminary Data

EPA states that at this time, the data related to the PFAS added by the NDAA and received by EPA include 89 TRI reporting forms for 44 discrete PFAS filed by 38 individual facilities. The preliminary data indicate facilities managed more than 700,000 pounds of production-related waste of PFAS during 2020. As EPA reviews the data, it will examine the types of facilities that reported and that did not report, the specific PFAS that were reported and not reported, the information reported, by whom, and the communities in which PFAS are being released or otherwise managed as waste. According to EPA, it will seek to learn to what extent the current TRI reporting requirements regarding PFAS were followed and are adequate in providing the public with important information on the waste management practices of PFAS.

In analyzing the PFAS reporting, EPA states that it will also include a “focused and more rapid effort” intended to provide insights regarding the “seemingly limited” scope of the reporting, including the types and number of facilities reporting and PFAS reported. Depending upon its findings, EPA will take action “as appropriate,” including providing compliance assistance, taking enforcement actions, or proposing modifications to the TRI reporting requirements for PFAS.

The 2020 TRI National Analysis will include a section providing more detailed information on PFAS, including discussion on the quantities of PFAS that were released to the environment, recycled, burned for energy recovery or treated; source reduction activities implemented on PFAS; the facilities and sectors that disclosed this information; and the communities in which these activities took place.

EPA states that it will continue to add PFAS to the TRI per the requirements of the NDAA. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a significant new use rule under the Toxic Substances Control Act (TSCA). According to EPA, the TRI data collected will help inform its efforts under EPA Administrator Regan’s EPA Council on PFAS to understand better and ultimately reduce the potential risks caused by PFAS.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has asked users of the Toxics Release Inventory (TRI) Program’s website to complete a website satisfaction survey. EPA states that it wants users to find information easily on the TRI website and ensure that the information is complete and understandable. EPA asks users to “take 5 minutes and tell us what you like about the website and data access tools and how we can improve them.” EPA asks for responses by June 30, 2021.

The TRI website allows users to search to identify industrial facilities in their communities that release chemicals into the air, water, and land. Users can learn what chemicals these facilities release, how these facilities are reducing releases, and potential health impacts of these releases.

Tags: TRI

 
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