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.

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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.

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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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 27, 2023, that it denied a January 26, 2023, petition from Blueland, Plastic Pollution Coalition, and partners, including Beyond Plastics, Plastic Oceans International, The Shaw Institute, Lonely Whale, 5 Gyres, Global Alliance for Incinerator Alternatives (GAIA), Oceanic Global Foundation, The Last Beach Cleanup, Rio Grande International Study Center, Inland Ocean Coalition, Occidental Arts and Ecology Center, Turtle Island Restoration Network, Friends of the Earth, Surfrider, and Made Safe. 88 Fed. Reg. 25590. The petition, filed under Section 21 of the Toxic Substances Control Act (TSCA), requested that EPA require manufacturers and processors of polyvinyl alcohol (PVA) affiliated with EPA’s Safer Choice certification program to fund and conduct health and environmental safety testing using independent, third-party scientists. The petition also requested, under the Administrative Procedure Act (APA), that EPA update the status of PVA on its Safer Chemical Ingredients List (SCIL) from “green circle” to “gray square” until testing is completed and reviewed by EPA. EPA states that “[a]fter careful consideration,” it has denied the TSCA petition and APA petition requests.
 
Disposition of Section 21 Response
 
EPA states that in considering the petition within the statutory 90-day petition review period, it evaluated the information presented or referenced in the petition and considered that information in the context of the applicable authorities and requirements contained in TSCA Sections 4, 21, and 26. EPA also evaluated relevant information that was “reasonably available” during the 90-day petition review period. According to EPA, it finds the petitioners have not provided the facts necessary to determine that existing information and experience are insufficient and that testing of such substance or mixture with respect to such effects is necessary to develop such information. These deficiencies include:

• May present unreasonable risk of injury to health or the environment or produced in substantial quantities: EPA finds that petitioners have not provided the facts necessary to determine that existing information and experience are insufficient and that testing with respect to such effects is necessary to develop such information. EPA states that it “agrees that PVA is or will be produced in substantial quantities and that there is or may be significant or substantial human exposure due to its common use in agriculture, foodstuffs, cleaning, and personal-care products,” however.
   
• Insufficiency of information in the petition: According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” on which the effects of PVA can reasonably be determined or predicted, as TSCA Section 4(a)(1) requires. EPA “finds the petitioners have not incorporated available existing information related to their request, or adequately indicated that gaps were located for data needed in order for EPA to make a decision using the best available science.” Such an evaluation is necessary for EPA to carry out TSCA Section 4, as provided under TSCA Section 26(h).
   
• Testing of such substance or mixture with respect to such effects is necessary to develop such information: EPA finds the petitioners have not explained why the testing requested, as compared to other testing or other data generation methods, would provide the quality of data being sought for EPA to make a decision using the best available science. EPA notes that such an evaluation is necessary for EPA to carry out TSCA Section 4, as provided under TSCA Section 26(h).
   
• Request for oversight by a third party: Regarding the petitioners’ request that testing be conducted only under the guidance and direction of independent third-party scientists, EPA finds that such an oversight arrangement is not in keeping with the authority provided under TSCA Section 21. Additionally, according to EPA, the petition has not demonstrated a need for additional measures ensuring the reliability of studies required under TSCA Section 4 beyond that already provided in the Good Laboratory Practice Standards in 40 C.F.R. Part 792, and the petitioners provide no legal, administrative, or organizational procedures for the implementation of such oversight. Therefore, EPA “has no obligation to grant or deny this request.”

EPA notes that additionally, because the authorities provided under TSCA Section 4 specifically relate to test rules, enforceable consent agreements, or orders issued directly to manufacturers and/or processors of a chemical substance, it cannot grant any requests made under Section 4 that extend beyond those statutory authorities. Therefore, according to EPA, the petitioners’ request for EPA to require third-party oversight of PVA testing, paid for by manufacturers and/or processors, is outside of the authorities provided in TSCA Section 4.
 
Disposition of the APA Portion of the Petition
 
EPA states that it has considered the evidence presented by petitioners and is denying the request to remove PVA from the SCIL for two reasons: the petition does not demonstrate that PVA fails to meet the Safer Choice criteria; and the data cited and explained in the notice indicate that the PVA structures allowed for use in Safer Choice-certified products under the EPA Safer Choice Standard meet the criteria of the program. EPA notes that the petition cites five blogs and eight peer-reviewed journal articles, mostly focused on the environmental impacts of microplastics rather than the soluble PVA used in Safer Choice-certified products. EPA identified additional peer-reviewed literature not discussed in the petition that is relevant to the PVA structures used in Safer Choice-certified products. According to EPA, the clear weight of the evidence presented in the notice demonstrates that the PVA structures allowed in Safer Choice-certified products meet the Safer Choice Criteria for Colorants, Polymers, Preservatives, and Related Chemicals. Specifically, “the PVA structures in Safer Choice-certified products that are the subject of this petition are not [persistent, bioaccumulative, and toxic (PBT)] substances, ‘very persistent and very bioaccumulative’ substances, or ‘very persistent and very toxic’ substances, and are expected to be of low concern for human health.” EPA therefore denies the request in the APA portion of the petition to change the status of PVA on the SCIL.
 
EPA states that it “does appreciate the petitioners’ concerns, especially related to plastic pollution and microplastics.” According to EPA, past efforts for transparency relevant to the petitioners’ concerns are reflected in the SCIL, and the SCIL includes a caveat for polymers: “Note for Polymers: The hazard profile of a polymer varies with its structure. Manufacturers using CAS numbers in this functional class may need to provide additional information for Safer Choice review,” available at https://www.epa.gov/saferchoice/safer-ingredients#searchList.

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By Lynn L. Bergeson and Carla N. Hutton
 
Earthjustice announced on April 7, 2023, that Cherokee Concerned Citizens, a community group in Pascagoula, Mississippi, filed suit in the U.S. Court of Appeals for the District of Columbia Circuit for review of an Order for a New Chemical Substance under Section 5 of the Toxic Substances Control Act (TSCA), signed by the U.S. Environmental Protection Agency (EPA). According to the petition, the August 11, 2022, Order authorizes Chevron U.S.A. Inc. to manufacture, process, distribute in commerce, use, or dispose of certain new chemical substances. The press release states that EPA approved the new chemicals to make fuels “despite finding that the resulting air pollution would pose a cancer risk 250,000 times greater than what the agency typically considers unreasonable.” According to the press release, EPA determined that the production of the new chemicals will pose up to a one in four cancer risk, meaning 25 percent of residents living nearby could develop cancer over their lifetime. The press release notes that under TSCA, EPA cannot approve new chemicals with serious health or environmental risks without identifying and implementing ways to minimize the dangers. EPA can also order lab testing that would clarify such risks. EPA did not do either before approving the request to produce this “hazardous fuel.”

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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.

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

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 2, 2023, that the Office of Enforcement and Compliance Assurance (OECA) will hold two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA, it will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the extent that PFAS cleanup enforcement efforts occur under CERCLA.” EPA states that there will be opportunities to provide verbal input during the public listening sessions and written input submissions in a separate form.
 
The listening sessions will focus on an enforcement policy related to responsible parties’ financial obligations under PFAS contamination response actions. EPA notes that the sessions “will not focus on the actions needed to address PFAS contamination or EPA’s progress in the Agency’s PFAS Strategic Roadmap commitments.”
 
The sessions will be held:

• Tuesday, March 14, 2023, from 1:00 p.m. to 3:00 p.m. (EDT); and
• Thursday, March 23, 2023, from 10:00 a.m. to noon (EDT).

EPA states that its CERCLA PFAS enforcement discretion and settlement policy “is aimed at addressing stakeholder concerns and reducing uncertainties by clarifying when EPA intends to use its CERCLA enforcement authorities or its CERCLA enforcement discretion.” To the extent that PFAS cleanup enforcement efforts occur under CERCLA, EPA will develop a CERCLA PFAS enforcement discretion and settlement policy. According to EPA, the policy will take into account various factors, such as EPA’s intention to focus enforcement efforts on PFAS manufacturers and other industries whose actions result in the release of significant amounts of PFAS into the environment, and EPA’s intention not to focus on pursuing entities where factors do not support taking an enforcement action.
 
Registration is required to attend a listening session. The registration form provides the option for participants to make live verbal remarks or to listen. Information on the opportunity to speak at the session is provided on the registration form. Written comments related to the listening sessions are due March 31, 2023.
 
EPA notes that these listening sessions are separate from its perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) hazardous substance designation rulemaking process. The input provided through the listening sessions is not part of the rulemaking comment docket. The hazardous substance designation rulemaking comment period has closed.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced outreach to describe how it evaluates engineering (i.e., environmental release and worker exposure) data for new chemical submissions and common causes of EPA having to reconduct risk assessments (i.e., “rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
The February 28, 2023, webinar is the third and final webinar in a series to increase the efficiency and transparency of EPA’s new chemical determinations. The first two webinars, held in July and October 2022, focused on common issues that cause EPA to rework risk assessments, clarifications of common misconceptions in EPA’s new chemical assessments, and other information related to TSCA Section 5 submissions. More information on these webinars is available on EPA’s website and in our July 28, 2022, and October 25, 2022, memoranda.

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