Bergeson & Campbell, P.C.’s (B&C^®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed 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 substances (PFAS) reporting and confidential business information (CBI) protections are equally significant, and all are likely to inspire significant disruption in the regulated community.
Watch the webinar now.

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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) 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 April 6, 2023, the U.S. District Court for the District of Columbia dismissed a suit brought by the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) to prevent Inhance Technologies USA (Inhance) from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. As reported in our January 6, 2023, blog item, CEH and PEER sought a court order restraining Inhance from continued manufacture of PFAS in violation of a 2020 significant new use rule (SNUR) “requiring it to stop all distribution of fluorinated containers in commerce until and unless [Toxic Substances Control Act (TSCA)] requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to [perfluorooctanoic acid (PFOA)] and other PFAS.” While CEH and PEER filed suit on December 27, 2022, the U.S. Environmental Protection Agency (EPA) filed suit on December 19, 2022, in the U.S. District Court for the Eastern District of Pennsylvania. According to the court’s April 6, 2023, opinion, Inhance filed a motion to dismiss the case brought by CEH and PEER, “arguing that the TSCA’s diligent-prosecution bar requires dismissal of this separate action.” The court states that the United States filed an amicus brief in support of Inhance’s motion, “arguing that this lawsuit ‘is a textbook case for application of the diligent prosecution bar.’” The court found that CEH and PEER failed to prove that the U.S. Department of Justice (DOJ) is not “diligently prosecuting” the action. The court reviewed the days between when DOJ filed its suit and CEH and PEER filed their suit, and found “[n]othing in the eight days between when DOJ filed its lawsuit and when Plaintiffs filed theirs suggests that Justice was not diligently prosecuting the case.” The court granted Inhance’s motion, dismissing the case without prejudice. The court noted that CEH and PEER have “the options of intervening in DOJ’s separate action or returning to court another day if Justice starts to slack at the reins.” According to an April 7, 2023, PEER press release, PEER and CEH will now move to intervene in DOJ’s suit in the U.S. District Court for the Eastern District of Pennsylvania.

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to submit the draft supplement to the SACC for peer review and is scheduling a four-day virtual public meeting for the SACC to consider and review the draft supplement in September 2023. Nominations are due April 24, 2023.
 
According to EPA, the focus of the four-day virtual public meeting is the SACC peer review of the methodologies that have not been previously peer reviewed and are used in the 2023 1,4-dioxane supplemental risk evaluation. EPA will consider feedback from this review in the development of the final supplement to the 1,4-dioxane risk evaluation. EPA notes that in addition, SACC reviewer feedback may help refine EPA’s methods for conducting release assessments and evaluating general population exposures in risk evaluations of other chemicals under the Toxic Substances Control Act (TSCA).
 
EPA intends to publish a separate document in the Federal Register to announce the availability of and solicit public comment on the draft supplement, at which time EPA will provide instructions for submitting written comments and registering to provide oral comments at the peer review meeting planned for September 2023. EPA also intends to provide a meeting agenda for each day of the meeting, and as needed, may provide updated times for each day in the meeting agenda that will be posted in the docket and on the SACC website.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, pollution prevention measures, and approaches for chemicals regulated under TSCA.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 28, 2023, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). As reported in our March 22, 2023, blog item, EPA has posted the justification for its FY 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act (TSCA):

• By September 30, 2026, complete at least eight high-priority substance TSCA risk evaluations annually within statutory timelines compared to the FY 2020 baseline of one;
   
• By September 30, 2026, initiate all TSCA risk management actions within 45 days of the completion of a final existing chemical risk evaluation; and
   
• By September 30, 2026, review 90 percent of risk management actions for past TSCA new chemical substances reported to the 2020 Chemical Data Reporting Rule (CDR) compared to the FY 2021 baseline of none.

Our March 24, 2023, blog item provides details on resources requested for the Safer Choice, Environmentally Preferable Purchasing (EPP), and Green Chemistry Programs. As reported in our March 23, 2023, memorandum, the Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s FY 2024 budget request.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents (FTE) to support the P2 Program in the Environmental Program and Management (EPM) appropriation, an increase of $16 million and 18 FTEs above the FY 2023 enacted budget. The CJ states that FY 2024 funding will continue to support the following P2 programs.
 
Safer Choice Program
 
The CJ states that Safer Choice is a voluntary program that certifies safer products so consumers, businesses, and purchasers can find products that work well and contain ingredients safer for human health and the environment. EPA certifies and allows use of the Safer Choice label on products containing ingredients that meet stringent health and environmental criteria. Under the same stringent criteria, EPA certifies disinfectant products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) using the Design for the Environment logo. According to the CJ, the Safer Choice Program will expand into additional product categories and seek to increase consumer and commercial recognition of Safer Choice products. In FY 2024, EPA will continue its Partner of the Year Awards Program, recognizing organizations and companies for their leadership in formulating products made with safer ingredients and making them available to communities.
 
The CJ states that in FY 2024, Safer Choice will integrate and address environmental justice (EJ) concerns through outreach and partnership activities. Efforts to make Safer Choice-certified products more accessible to communities with EJ concerns will expand, with particular focus on low-income, Tribal, and indigenous populations and other vulnerable populations such as the elderly, children, and those with pre-existing medical conditions. According to the CJ, Safer Choice will work with retailers and product manufacturers to help them develop more products containing safer chemical ingredients that are easy to identify and purchase. Safer Choice will also work to empower custodial staff and house cleaning companies and enable facilities through education to gain access to Safer Choice-certified products to improve indoor air quality and reduce exposure-related asthma.
 
Environmentally Preferable Purchasing (EPP) Program
 
The EPP Program implements direction provided to EPA in several statutes and Executive Orders that mandate sustainable federal procurement, including through development and use of sustainability standards, specifications, and ecolabels. Beginning in FY 2023, the EPP Program is expanding the EPA Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing in new categories to support the Biden Administration’s environmental and human health goals and mandates, including net-zero emissions procurement, low embodied carbon construction materials, and products that do not contain per- and polyfluoroalkyl substances (PFAS). According to the CJ, the EPP Program has received applications for over 70 standards/ecolabels from 29 organizations to be considered for assessment and recommendation in federal purchasing. These cover the following high-impact federal procurement sectors: food and cafeteria services; uniforms/clothing; professional services; laboratories and healthcare; building/construction; infrastructure; and landscaping.
 
The CJ notes that EPA is characterizing PFAS provisions of existing private-sector sustainability standards, ecolabels, and certifications to identify products and purchase categories associated with key PFAS use and to prioritize PFAS conditions of use. In FY 2024, EPA will enhance public protection from potential effects of PFAS through recommendations of additional standards/ecolabels to help purchasers identify products that meet specific environmental performance criteria. EPA will conduct the following activities:

• Assess and recommend additional ecolabels and standards with criteria specifically supporting reduction or elimination of PFAS use in key product categories not yet covered by the EPA Recommendations for Standards, Specifications, and Ecolabels for Federal Purchasing.
• Build, implement, maintain, and update tools for integrating EPA recommendations into federal e-procurement systems, initiate identification and monitoring of relevant government contracts for sustainable purchasing requirements, and develop tools to ensure that PFAS data are captured for compliance in the Federal Procurement Data System (FPDS).
• Initiate and engage in private-sector standards development activities that address product categories known to contain PFAS.
• Work with the General Services Administration (GSA) and others to create a central product registry to identify products that meet EPA’s assessment of PFAS specifications.
• Collaborate with the Department of Defense (DOD) on performance-based, rather than material-based, specifications and standards for equipment (e.g., textiles, coatings, firefighting foam) for DOD and Department of Homeland Security (DHS) uses.
• Work with other federal agencies and the private sector to initiate a performance-based technology innovation challenge for a set of PFAS-free product categories for which use of non-PFAS options could be technically and economically feasible with respect to key federal purchasing categories.

According to the CJ, to support further EPA’s goals for equity and EJ, the EPP Program will begin to develop and implement training and outreach for disadvantaged communities, as well as state, Tribal, and local governments, to assist in facilitating product and service procurement choices that are environmentally sound and promote human and environmental health.
 
Green Chemistry Program
 
According to the CJ, the Green Chemistry Program fosters the sustainable design of chemical products and processes. It also analyzes green chemistry innovations and works with partners and external stakeholders to facilitate market adoption and penetration of new commercially successful chemistries and technologies. The CJ states that the program’s Green Chemistry Challenge Awards serve a critical role in raising the profile, importance, and credibility of innovative and market-ready green and sustainable chemistry technologies. In FY 2024, the Green Chemistry Program will begin to work with awardees and nominees to pursue the goal of market-oriented environmental and economic progress through increased adoption of these innovations. The CJ notes that EPA will support and lead portions of EPA’s responsibilities for implementation of the Sustainable Chemistry Research and Development Act of 2020. More information on the Sustainable Chemistry Research and Development Act of 2020 is available in our January 19, 2021, memorandum.

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