By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released on June 30, 2022, a report entitled “Additional Internal Controls Would Improve the EPA’s System for Electronic Disclosure of Environmental Violations.” OIG conducted the evaluation to determine whether EPA’s process for screening self-reported violations through its electronic disclosure, or eDisclosure, system is effective and ensures that significant concerns, such as criminal conduct and potential imminent hazards, are addressed by the Office of Enforcement and Compliance Assurance (OECA). According to OIG’s report, the goal of the eDisclosure system is to provide an efficient mechanism for regulated entities to self-disclose violations of federal environmental laws and regulations. Self-disclosed violations are automatically processed under the EPA’s audit policies. EPA subsequently screens certain eDisclosure submissions to ensure that significant concerns, such as criminal conduct and potential imminent hazards, are properly addressed.
OIG states that the eDisclosure system does not have adequate internal controls in place to ensure that EPA’s screening process is effective and that significant concerns, such as criminal conduct and potential imminent hazards, are identified and addressed by OECA and the EPA regions. OIG notes that there is no formal, written national guidance or eDisclosure-specific training available on how EPA staff should conduct screening or delineate staff responsibilities. According to OIG, as a result, most regions inconsistently screen for significant concerns or do not screen at all because they believe OECA is responsible for that task, do not have access to the eDisclosure system, or have other resource limitations. Further, EPA does not have performance measures and does not systematically track eDisclosure system data. Finally, OIG states the eDisclosure system’s reporting tool “does not allow staff to effectively or robustly use or track eDisclosure submissions.” OIG concluded that without national screening guidance, training, effective monitoring, and Central Data Exchange improvements, there is a risk that significant concerns are not being addressed and that the impacts of the EPA’s eDisclosure system will remain limited and unknown.
OIG recommends that the OECA Assistant Administrator develop national guidance that includes a process for screening eDisclosure submissions for significant concerns; provide eDisclosure-specific training to EPA headquarters and regions to clarify expectations, establish staff responsibilities, and communicate best practices; develop performance measures for the eDisclosure system, as well as a monitoring plan to track its effectiveness; and assess eDisclosure system functionality to identify and implement improvements. According to OIG, OECA agreed with all four of its recommendations and proposed acceptable corrective actions and estimated completion dates. All recommendations are resolved with corrective actions pending. Where appropriate, OIG revised the report based on technical comments provided by OECA.
Wednesday, August 3, 2022
12:00 p.m. - 1:00 p.m. (EDT)
The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”
These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:
- Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
- Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions;
- Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
- Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.
Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH, as Bergeson & Campbell, P.C. (B&C®) presents “TSCA New Approach Methodologies.”
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She 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.
Richard E. Engler, Ph.D., Director of Chemistry, B&C, 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.
James W. Cox, M.S., Senior Scientist, B&C, developed risk assessments and advised on hazard characterization processes under TSCA while working as Acting Lead Biologist in EPA’s OPPT New Chemicals Division. While at EPA, he helped develop a framework to complete risk assessments for novel petroleum alternatives and evaluated the hazard and risks to human health from exposure to industrial chemicals, biological agents, and nanomaterials.
Kristie Sullivan, MPH is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), a nationwide organization of physicians and laypersons that promotes preventive medicine and ethics in research. As Vice President of Research Policy, Ms. Sullivan directs PCRM’s efforts to promote human-relevant alternatives to the use of animals in medical research, education, and the testing of drugs, chemicals, and other products through scientific scholarship and outreach to companies, federal agencies, legislators, and others. Ms. Sullivan has 15 years’ experience in legislative, policy, science, and training activities related to the implementation of New Approach Methodologies, including by engaging with EPA, the Organization for Economic Cooperation and Development, and the regulated industry.
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) announced on July 6, 2022, that it is inviting small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel that will focus on EPA’s development of a proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process. EPA states that the proposed rule would establish a framework of reporting requirements based on a chemical’s status in the TSCA Section 6 Risk Evaluation/Risk Management Lifecycle. Additionally, the new data reporting rule would enhance the exposure-related data collected through the TSCA Chemical Data Reporting (CDR) process. According to EPA, collecting data geared specifically towards prioritization, risk evaluation, and risk management would help ensure that EPA has relevant and timely data to inform each step of the process for reviewing potential risks from existing chemicals. Self-nominations are due July 20, 2022.
The data reporting rule, including changes to CDR, is tiered to specific stages of the TSCA Section 6 existing chemicals program:
- Identifying a pre-prioritization pool of substances as potential candidates for prioritization;
- Selecting candidate chemicals and completing the prioritization process; and
- Assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation).
According to EPA, tying specific reporting requirements to the activities that make use of reported data will also reduce the burden related to data collection efforts while ensuring that EPA has the information it needs to fulfill its risk evaluation and risk management responsibilities. EPA intends the proposed rule to create a framework to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA’s ability to collect data under this proposed rule would derive from authorities in TSCA Sections 8(a) and 8(d), which give EPA authority to require:
- Manufacturers and processors to provide known or reasonably ascertainable information, including chemical identity, production volumes, uses, byproducts, and worker exposure; and
- Manufacturers, processors, and distributors to submit health and safety information.
EPA states that the potentially regulated community consists of entities that manufacture, import, or process chemical substances, potentially including when the chemical substance is manufactured as a byproduct or is part of a formulated product or article (including import and processing). According to EPA, it anticipates most respondents affected by this collection activity to be from the manufacturing sectors, including chemical manufacturing; petroleum and coal product manufacturing; chemical, petroleum, and merchant wholesalers; paper, plastics, paint, and printing ink manufacturing; electronic product and component manufacturing; or other activities, including utilities and construction.
The Panel, convened under the authority of the Small Business Regulatory Enforcement Fairness Act, will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The Panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, government, or organization to inform the Panel members about the potential impacts of the proposed rule on small entities. EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.
More information on EPA’s July 27, 2021, webinar on the development of the rule is available in our July 29, 2021, memorandum.
On June 29, 2022, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Six Years Later.” This virtual conference marked the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics, including the interface of science and policy under TSCA, the U.S. Environmental Protection Agency’s (EPA) regulation of new chemicals, risk assessment and risk management, and the regulation of articles under TSCA. The over 700 program registrants demonstrate the continuing, if not growing, interest in EPA’s challenging implementation of TSCA. A recording of the conference is available online. More information on this event is available in our July 5, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The Internal Revenue Service (IRS) announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The IRS released Revenue Procedure 2022-26, which provides the exclusive procedures for requesting a determination under Section 4672(a)(2) of the Internal Revenue Code (Code) that a substance be added to or removed from the list of taxable substances under Section 4672(a) of the Code (List). The sale or use of any such taxable substances by importers of such substances is subject to the excise tax imposed by Section 4671(a) of the Code, subject to certain exceptions. Section 4 of the revenue procedure states that an importer or exporter of any substance, or a person other than an importer or exporter of such substance (interested person), may request to add such substance to the List or remove such substance from the List by submitting a petition to the IRS. According to the revenue procedure, any requests to modify the List that were submitted prior to publication of this revenue procedure or in response to the request for comments in Notice 2021-66 do not meet the requirements of this revenue procedure. The IRS will not process such requests. A petition may be submitted to add a substance to the List if taxable chemicals constitute more than 20 percent of the weight or value of the materials used to produce such substance. A petition may be submitted to remove a substance from the List if taxable chemicals constitute 20 percent or less of the weight and 20 percent or less of the value of the materials used to produce such substance. Separate petitions must be submitted for each substance to be added to or removed from the List. The IRS will publish a Notice of Filing in the Federal Register, beginning a 60-day comment period on the petition. In the case of a petition submitted by an importer or exporter of a substance, the IRS will make a determination within 180 days after the date the petition is filed. The 180-day determination period may be extended by agreement between the petitioner and the IRS. The 180-day determination period does not apply to petitions submitted by interested persons (a person other than an importer or exporter of such substance).
By Lynn L. Bergeson and Carla N. Hutton
The Internal Revenue Service announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The FAQs detail what the Superfund chemical excise tax is, how the tax is computed, and who may be liable for the tax. The Superfund chemical taxes will be reported on Form 720, Quarterly Federal Excise Tax Return, and Form 6627, Environmental Taxes. The excise taxes were reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The IRS notes that there are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” Specifically, the reinstated taxes impose an excise tax on the sale or use of a taxable chemical by the manufacturer, producer, or importer of the taxable chemical. They also impose an excise tax on the sale or use of a taxable substance by the importer of the taxable substance. The IRS states that the FAQs provide general information. According to the IRS, at the time of publication of these FAQs, 151 substances are listed as taxable substances. The IRS states “[t]hat number will likely change as substances are added to or removed from the list of taxable substances.” The FAQs added June 24, 2022, include:
Q1. What are the Superfund chemical excise taxes?
Q2. When do the Superfund chemical excise taxes go into effect?
Q3. What is a taxable chemical?
Q4. What is a taxable substance?
Q5. How are substances added to or removed from the list of taxable substances?
Q6. How do I calculate the section 4661 tax?
Q7. I am an importer of taxable substances. How do I calculate the section 4671 tax?
Q8. What happens if an importer does not calculate the section 4671 tax?
Q9. Will the IRS prescribe tax rates for taxable substances?
Q10. Who is responsible for reporting and paying Superfund chemical excise taxes?
Q11. How are the Superfund chemical excise taxes reported?
Q12. When is the first return due?
Q13. Are semimonthly deposits required?
Q14. Under what circumstances is registration required?
Q15. Is there a way to check the status of an application for Activity Letter G registration?
More information on the Superfund excise tax on certain chemical substances is available in our May 19, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2022, the Senate Committee on Environment and Public Works will hold a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).
B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. Register here.
Full Agenda (subject to change):
|9:15 a.m. - 9:30 a.m.
||Welcome and Overview of Virtual Forum
|9:30 a.m. - 10:00 a.m.
||Morning Keynote Discussion
Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)
|10:15 a.m. - 11:45 a.m.
||Panel 1: The Interface of Science and Policy under TSCA
This panel will examine key issues at the interface of science and policy under TSCA, including the continuing role of animal studies in supporting risk evaluations, the potential use of New Approach Methodologies (NAM) to inform safety determinations for new and existing chemicals, scientific integrity and the TSCA program, methodologies for systematic review, and more.
Moderated by James J. Jones, President, J. Jones Environmental
|12:00 p.m. - 1:30 p.m.
||Panel 2: New Chemical Review
The TSCA New Chemicals Program was strengthened in the 2016 Lautenberg Amendments and what the law requires has been vigorously debated. This panel will discuss opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, use of Significant New Use Rules (SNUR) and Section 5(e) orders, and more.
Moderated by Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
|1:45 p.m. - 3:15 p.m.
||Panel 3: Risk Evaluation and Management
With the “first 10” evaluations completed, this panel will look back at the lessons learned and areas for improvement; discuss EPA efforts to enhance these evaluations through risk determinations for fenceline communities, revised worker protection assumptions, and the “whole chemical approach”; examine the asbestos risk management proposal and other emerging risk management approaches; evaluate the impact of resource constraints on meeting statutory deadlines; discuss the role of environmental justice considerations; and more.
Moderated by Robert M. Sussman, Principal, Sussman & Associates
|3:30 p.m. - 5:00 p.m.
||Panel 4: TSCA Regulation of Articles
TSCA requirements can apply to “articles,” a manufactured good or finished product. This panel will discuss the potential role of articles as contributors to health and environmental concerns, EPA’s push to remove traditional exemptions of articles and resulting compliance and implementation challenges, potential new rules for per- and polyfluoroalkyl substances (PFAS) and asbestos requiring reporting on articles, and the application of SNURs and risk management rules to articles, and more.
Moderated by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C.
|5:00 p.m. – 5:10 p.m.
||Concluding Remarks and Adjournment
Join B&C, ELI, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA. Full program and registration available online.
Materials from the 2021 conference are available at https://www.lawbc.com/news/recording-of-tsca-reform-five-years-later-conference-and-other-resources-av
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:
- Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
- Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
- Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
- Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
- Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.
EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.
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.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA Section 15(3)(B). EPA notes that TSCA Section 12(b), and the regulations set forth at 40 C.F.R. Section 707.60, require any person who exports or intends to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA Sections 5 or 6 to notify EPA of such exportation to a particular country. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. The complaint states that Vorbeck has claimed the identity of the carbon nanomaterial as TSCA confidential business information (CBI). Vorbeck has subsequently submitted a TSCA Section 12(b) export notification for the carbon nanomaterial.
Based upon the facts alleged in the complaint, and upon the nature, circumstances, extent, and gravity of the violations alleged, as well as Vorbeck’s ability to pay, effect on ability to continue to do business, any history of prior such violations of TSCA, the degree of culpability, and such other matters as justice may require, EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved.
By Lynn L. Bergeson and Carla N. Hutton
On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). As reported in our March 25, 2022, blog item, EPA announced on March 24, 2022, that it issued a second round of test orders under TSCA Section 4 to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. The VI seeks judicial review of the test order under federal law, including but not limited to the Administrative Procedure Act (APA), TSCA, and EPA’s regulations promulgated thereunder. The VI seeks a determination that, inter alia, the test order violates these authorities; is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; is without observance of procedure required by law; is unsupported by substantial evidence; and is otherwise contrary to law. The VI asks that the court hold unlawful, vacate, enjoin, set aside, and remand the test order.
By Lynn L. Bergeson and Carla N. Hutton
On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with the Office of Chemical Safety and Pollution Prevention (OCSPP), proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA.
EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.
EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:
- Using data to develop predictive models and use of predictive models in data-poor environments:
- Read across and analogue selection;
- Chemical structures and cheminformatics; and
- Quantitative structure-activity relationships (QSAR);
- Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:
- Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
- Reference data curation to support validation;
- Computational modeling, bioinformatics, and/or statistics;
- Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);
- Systems biology;
- Human health and ecological risk assessment;
- Exposure modeling and/or assessment, including near-field and far-field sources;
- Knowledge of TSCA; and
- Environmental fate of chemicals.
Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.
Bergeson & Campbell, P.C.’s (B&C®) May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. During the webinar, Ms. Sellers outlined barriers and enablers to the circular economy, including practical challenges like supply chain limitations and industry frameworks; Dr. Engler highlighted how the Toxic Substances Control Act (TSCA) regulates discarded substances used as feedstocks by others and articles that may contain contaminants that could affect how an article is classified by the U.S. Environmental Protection Agency (EPA) under TSCA; and Mr. Stanislaus reviewed policy issues, including waste management hierarchy, circular economy hierarchy, and other mechanisms that incentivize sustainability.
We encourage you to view the webinar, listen to the All Things Chemical® episodes “Trends in Product Sustainability and Circularity — A Conversation with Kate Sellers” and “How Can Battery Production Be Greener? — A Conversation with Mathy Stanislaus,” read ERM’s report Circularity: From Theory to Practice, and subscribe to B&C’s informative blogs and newsletters.