> Section 6 Existing Chemicals
Posted on May 16, 2023 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2023, that it will hold a webinar on June 7, 2023, at 1:00 p.m. (EDT) on its proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would ban all consumer uses and most commercial uses of methylene chloride, “a chemical in commercial and consumer products known to cause serious health risks and even death.” As reported in our April 25, 2023, memorandum, EPA proposes prohibitions and protections, with a rapid phase-down for manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, a majority of which would be fully implemented in 15 months after the final rule is issued. For industrial manufacturing, industrial processing, laboratory use, and federal uses that EPA is not proposing to prohibit, EPA proposes a workplace chemical protection program (WCPP) with strict exposure limits to protect workers better. The WCPP would require employers and others covered by it to comply with safety requirements within one year. They would also be required to periodically monitor their workplaces to ensure that workers and others on site are not being exposed to levels of methylene chloride that would lead to an unreasonable risk. Comments on the proposed rule are due July 3, 2023.
According to EPA, the webinar “will be useful for anyone looking for an overview of the proposed regulatory action or to provide input on the proposed program, including industry groups, nonprofit organizations, Tribes, and other stakeholders.” EPA states that it is particularly looking for participation from employers and workers “who can give perspective on the feasibility and efficacy of the proposed requirement for worker protections.”
Participants can register as listeners or to make prepared remarks. To provide remarks during the webinar, registration must be completed by May 24, 2023, at 5:00 p.m. (EDT). Registration as a listener can be completed up until the start of the webinar. Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com. EPA states that it will provide copies of the presentation material on its website following the webinar.
Posted on May 08, 2023 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On May 3, 2023, the U.S. Environmental Protection Agency (EPA) announced its intent to extend the January 6, 2023, compliance date on the prohibition on the processing and distribution of decabromodiphenyl ether (decaBDE) for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation. As reported in our December 23, 2020, memorandum, decaBDE is one of the persistent, bioaccumulative, and toxic (PBT) chemicals that are the subject of risk management rules under the Toxic Substances Control Act (TSCA) issued in 2021. EPA states that it “expects to propose this compliance date extension as part of a rulemaking on the chemical this fall.”
EPA also issued a related temporary “Enforcement Statement,” which indicates that it does not intend to pursue violations of this prohibition on processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, “as long as the entities involved are diligently working to qualify their alternative components in accordance with Nuclear Regulatory Commission regulations and guidance.” EPA also announced a settlement agreement with RSCC Wire & Cable, LLC (RSCC), “the only known supplier of qualified decaBDE-containing wire and cable, regarding TSCA violations.”
According to EPA, it only became aware in late 2022 that RSCC would not be able to meet the January 6, 2023, deadline due to its inability to transition fully to an alternative. EPA states that as a result, downstream customers such as nuclear power plants could face potential shutdowns due to being unable to source and obtain decaBDE-free qualified wires and cables that meet NRC regulations. EPA notes that “[t]his issue was exacerbated by a lack of effective communication by the nuclear power sector with EPA despite multiple opportunities to comment on EPA’s rulemaking decisions.”
EPA notes that the Enforcement Statement also covers related recordkeeping requirements and the use of decaBDE-containing wire and cable. EPA states that the Enforcement Statement does not cover the prohibition of all processing and distribution in commerce of decaBDE (i.e., raw or compounded) for use in wire and cable insulation in nuclear power generation facilities.
According to EPA, on May 1, 2023, EPA reached a settlement with RSCC, “which is the Agency’s first settlement under TSCA section 6 since TSCA was amended in 2016.” EPA states that “[s]pecifically, this settlement with RSCC resolves import violations of the manufacturing prohibition of decaBDE-containing products for nine imports that occurred between March 8, 2021 and January 6, 2023.” Under the 2021 TSCA rules for PBT chemicals, EPA set an extended compliance date for the processing and distribution of decaBDE-containing wire and cable of January 6, 2023. The compliance date for the import of decaBDE-containing wire and cable was March 8, 2021. Therefore, RSCC’s import of decaBDE-containing products after this date was a violation of TSCA. EPA notes that the settlement includes conditions to allow both the continued manufacturing, processing, and distribution of decaBDE-containing wire and cable insultation and the processing, and distribution of decaBDE (including raw and compounded) while the nuclear power generation industry undergoes transition to a decaBDE-free alternative.
Posted on May 04, 2023 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On May 3, 2023, the U.S. Environmental Protection Agency (EPA) proposed to prohibit most uses of methylene chloride under Section 6(a) of the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 28284. EPA states in its April 20, 2023, press release that its unreasonable risk determination for methylene chloride was driven by risks associated with workers, occupational non-users (ONU), consumers, and those in close proximity to a consumer use. EPA identified risks for adverse human health effects, including neurotoxicity, liver effects, and cancer from inhalation and dermal exposures to methylene chloride. According to EPA, its proposed risk management rule would “rapidly phase down” manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, most of which would be fully implemented in 15 months. EPA notes that for most of the uses of methylene chloride that it proposes to prohibit, its analysis found that alternative products with similar costs and efficacy to methylene chloride products are generally available. Comments on the proposed rule are due July 3, 2023. EPA notes that 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 your comments on or before June 2, 2023.”
According to the proposed rule, pursuant to TSCA Section 6(b), EPA determined that methylene chloride presents an unreasonable risk of injury to health, without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the 2020 methylene chloride risk evaluation, under the conditions of use (COU). To address the unreasonable risk, EPA proposes, under TSCA Section 6(a), to:
- Prohibit the manufacture, processing, and distribution of methylene chloride for all consumer use;
- Prohibit most industrial and commercial use of methylene chloride;
- Require a workplace chemical protection program (WCPP), including inhalation exposure concentration limits and related workplace exposure monitoring and exposure controls, for ten COU of methylene chloride (including manufacture; processing as a reactant; laboratory use; industrial or commercial use in aerospace and military paint and coating removal from safety-critical, corrosion-sensitive components by federal agencies and their contractors; industrial or commercial use as a bonding agent for acrylic and polycarbonate in mission-critical military and space vehicle applications, including in the production of specialty batteries for such by federal agencies and their contractors; and disposal);
- Require recordkeeping and downstream notification requirements for manufacturing, processing, and distribution in commerce of methylene chloride;
- Provide a ten-year time-limited exemption under TSCA Section 6(g) for civilian aviation from the prohibition addressing the use of methylene chloride for paint and coating removal to avoid significant disruptions to critical infrastructure, with conditions for this exemption to include compliance with the WCPP; and
- Provide a ten-year time-limited exemption under TSCA Section 6(g) for emergency use of methylene chloride in furtherance of the National Aeronautics and Space Administration’s mission for specific conditions which are critical or essential and for which no technically and economically feasible safer alternative is available, with conditions for this exemption to include compliance with the WCPP.
More information on EPA’s proposed rule is available in our April 25, 2023, memorandum.
Posted on April 19, 2023 by Lynn L. Bergeson
May 17, 2023
11:00 a.m. - 12:00 p.m. EDT
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing EPA decisions under TSCA Sections 5 and 6. Other consequential rulemakings involving per- and polyfluoroalkyl substance (PFAS) reporting and confidential business information (CBI) protections are equally significant, and all are likely to inspire significant disruption in the regulated community. Join us for an intense one-hour update on these and other issues in a discussion with Dr. Anna B. Lowit, OPPT’s Senior Science Advisor, and Bergeson & Campbell, P.C.’s (B&C®
) Director of Chemistry, Dr. Richard E. Engler.
Anna B Lowit, Ph.D.
- New Approach Methodologies
- Systematic Review
- Cumulative Risk Assessment
- Update on Section 6 Risk Evaluations
- The Latest TSCA Rulemakings, Including PFAS Reporting, CBI, and TSCA Fees
, Senior Science Advisor, OPPT, advises on a diversity of science policy issues. Dr. Lowit previously served at Senior Science Advisor for EPA’s Office of Pesticide Programs. She is currently co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods.
Richard E. Engler, Ph.D.
is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s OPPT and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, and pre-notice and post-review meetings with submitters to resolve complex cases.
Lynn L. Bergeson
, Managing Partner, B&C, 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 pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and analog global chemical product programs. Ms. Bergeson is Chair of the International Bar Association (IBA) Agriculture and Food Section, is Immediate Past President of the Product Stewardship Society (PSS) and serves on the Executive Committee of the American College of Environmental Lawyers (ACOEL).
Posted on April 14, 2023 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1, 2023, memorandum, earlier this year, EPA released for public comment and peer review a set of principles for evaluating cumulative risks under TSCA and an approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals undergoing TSCA Section 6 risk evaluation.
- Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: The document discusses what cumulative risk assessment is and how it could be used in the scientific and regulatory context of TSCA. EPA notes that a cumulative risk assessment “will not always be the best approach, or possible to complete in the statutory timeframes provided for TSCA risk evaluations. But when chemicals are sufficiently similar toxicologically and are found to present co-exposures -- meaning people are . . . exposed to multiple chemicals at the same time -- a cumulative risk assessment may be appropriate.”
- Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested Phthalate under the Toxic Substance Control Act: The document describes a proposed methodology for evaluating cumulative risk for the phthalate chemicals currently under review. EPA proposes in its approach submitted for public comment and peer review that di-ethylhexyl phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), di-isobutyl phthalate (DIBP), dicyclohexyl phthalate (DCHP), and di-isononyl phthalate (DINP) (but not di-isodecyl phthalate (DIDP)) are toxicologically similar (and pose an additive hazard) and that the U.S. population is co-exposed to these phthalates. Therefore, EPA proposes to group these phthalates for cumulative risk assessment under TSCA as described in the “Draft Proposed Approach” document. EPA notes that this proposed approach “is not itself a cumulative risk assessment nor does it make a finding of risk, but rather is a methodology that EPA proposes to use and seeks public input about and peer review on.”
Registration for the virtual preparatory meeting is open. To participate as a listen-only attendee, registration will be open up to the end of the meeting. Requests to make brief (up to five minutes) oral comments to the SACC during the preparatory meeting can be submitted when registering and will be accepted until April 21, 2023.
The two draft documents, draft charge questions, and other supporting materials are available online in docket EPA-HQ-OPPT-2022-0918. Written comments are due April 28, 2023, for distribution to SACC before the meeting.
Posted on October 14, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On October 11, 2022, the U.S. Chemical Safety Board (CSB) released its final investigative report into “a massive fire and explosions” at the Philadelphia Energy Solutions Refinery in Philadelphia, Pennsylvania, that occurred in June 2019. According to CSB, the incident occurred when a corroded pipe elbow ruptured, releasing process fluid into the refinery’s hydrofluoric acid (HF) alkylation unit. CSB states that over 5,000 pounds of “highly toxic” HF were released, “a 38,000-pound vessel fragment launched off-site and landed on the other side of the Schuylkill River, and an estimated property damage loss of $750 million resulted.”
In its final report, CSB notes that the U.S. Environmental Protection Agency (EPA) has not yet prioritized HF or performed a risk evaluation of HF under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. According to CSB, HF “is one of the eight most hazardous chemicals regulated by the EPA Risk Management Program (RMP).” CSB states that it concludes that EPA should initiate prioritization to evaluate whether HF is a high-priority substance for risk evaluation under TSCA. If HF is determined to be a high-priority substance, EPA should conduct a risk evaluation of HF and implement any identified corrective actions, as required by TSCA. CSB “recommends to EPA to take such action.”
While we agree that HF is a highly hazardous substance that warrants prioritization for review under Section 6 of TSCA, it is not clear how a TSCA risk evaluation will address the risks related to accidents, such as the one that was the subject of this CSB investigation. Congress clearly stated that “reasonably foreseen” conditions of use exclude misuse of a chemical substance. CSB concluded that the facility had failed to meet its obligations under the Occupational Safety and Health Administration (OSHA) and other EPA regulations, and the accident was the result of the failure of a section of pipe that was decades old. We would argue that such a failure was a misuse of HF. As a result, we would expect a TSCA risk evaluation to conclude that as long as appropriate engineering controls are used to prevent worker exposure and prevent releases to the neighboring communities under the intended and reasonably foreseen conditions of use, there is not an unreasonable risk. EPA’s review might lead to the imposition of a lower workplace exposure limit (than the OSHA permissible exposure limit (PEL)) and might lead to a lower Hazardous Air Pollutant standard under the Clean Air Act. Neither of these protective measures would have prevented the accident. Others may argue that an accidental release is reasonably foreseen (after all, it did happen), but, in our view, this accident was the result of misuse, so it is outside the definition of reasonably foreseen conditions of use.
Posted on July 08, 2022 by Lynn L. Bergeson
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.
Posted on July 07, 2022 by Lynn L. Bergeson
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.
Posted on May 24, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 24, 2022, that it is extending the public comment period for the April 12, 2022, proposed rule that would prohibit ongoing uses of chrysotile asbestos to give stakeholders more time to review the proposed regulation and prepare comments. EPA is extending the comment period an additional 30 days, from June 13, 2022, to July 13, 2022.
As reported in our April 7, 2022, memorandum, the proposed rule would ban chrysotile asbestos, the only known form of asbestos that is currently imported into the United States and is found in products like asbestos diaphragms used by the chlor-alkali industry, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets also imported into the United States. EPA also proposed targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). The proposed disposal and recordkeeping requirements would take effect 180 days after the effective date of the final rule.
Posted on April 13, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) proposed on April 12, 2022, to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. 87 Fed. Reg. 21706. EPA proposes under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA proposes that these prohibitions take effect two years after the effective date of the final rule. EPA also proposes to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA further proposes to prohibit manufacture (including import), processing, and distribution in commerce of: aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA also proposes disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. Comments on the proposed rule are due June 13, 2022. A detailed analysis of the proposed rule is available in our April 7, 2022, memorandum.