By Lynn L. Bergeson and Carla N. Hutton
 
On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
 
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or e-mail request.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 22, 2023, Public Employees for Environmental Responsibility (PEER) and Center for Environmental Health (CEH) submitted “extensive comments to the U.S. Environmental Protection Agency (EPA) demonstrating serious health risks from Inhance Technologies’ unlawful manufacture of per-and polyfluoroalkyl substances (PFAS) during its fluorination of hundreds of millions of plastic containers.” According to PEER’s press release, the comments call on EPA “to deny the company’s request for approval to continue this dangerous practice and use its authority under the Toxic Substances Control Act (TSCA) to eliminate this unacceptable risk to human health and the environment.” PEER and CEH submitted the comments in response to 18 significant new use notifications (SNUN) submitted by Inhance pursuant to the 2020 significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances.
 
As reported in our April 11, 2023, blog item, PEER and CEH filed suit in the U.S. District Court for the District of Columbia to prevent Inhance from generating PFAS when fluorinating plastic containers. PEER and CEH sought a court order restraining Inhance from continued manufacture of PFAS in violation of the 2020 SNUR. While PEER and CEH filed suit on December 27, 2022, EPA filed suit on December 19, 2022, in the U.S. District Court for the Eastern District of Pennsylvania. Inhance filed a motion to dismiss the case brought by PEER and CEH, “arguing that the TSCA’s diligent-prosecution bar requires dismissal of this separate action.” The U.S. District Court for the District of Columbia found that PEER and CEH failed to prove that the U.S. Department of Justice (DOJ) is not “diligently prosecuting” the action and granted Inhance’s motion on April 6, 2023, dismissing the case without prejudice.
 
According to PEER and CEH, recent legal filings by the government in the U.S. District Court for the Eastern District of Pennsylvania indicate that the government does not plan to stop unlawful PFAS production by Inhance while EPA considers its requests for approval. PEER and CEH contend that EPA “has a legal obligation to halt these practices.”

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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 11, 2023, the U.S. Environmental Protection Agency (EPA) held a webinar on its Draft National Strategy to Prevent Plastic Pollution (Draft Strategy). As reported in our May 2, 2023, memorandum, EPA states in its April 21, 2023, press release that the Draft Strategy includes “ambitious actions to eliminate the release of plastic and other waste from land-based sources into the environment by 2040.” During the webinar, EPA provided an overview of the Draft Strategy and the key questions on which EPA seeks comment. Comments on the Draft Strategy are due June 16, 2023. According to EPA’s website, it recorded the webinar and will post it online “soon.”

The webinar included a question and answer (Q&A) period. EPA stated that it would answer questions only to clarify information and that substantive comments should be submitted to the docket. Questions included:

• Can you please explain EPA’s thinking behind the new testing requirements for pyrolysis (or chemical recycling) facilities?
• How does EPA expect to meet Objective A, reduce pollution during plastic production, without addressing toxic chemicals used in plastic production?
• Given the ubiquity of chemical additives that are threats to human health, how will EPA ensure that the circular economy does not circulate toxic chemicals?
• Will elimination of per- and polyfluoroalkyl substances (PFAS) in plastics be mandated?
• There are 48 pages in the draft strategy and toxics shows up in three places. How does EPA expect to reach its goals without discussing toxics?

EPA suggested that these questions be submitted in written comments. In a few cases, EPA responded that the office that developed that portion of the Draft Strategy (presumably the Office of Chemical Safety and Pollution Prevention (OCSPP)) was not on the webinar. EPA stated that it would like to hear about any additional actions that should be included in the Draft Strategy. When asked whether increasing consumer awareness includes labeling, EPA noted that the Federal Trade Commission (FTC) has requested public comment on potential updates to its Guides for Use of Environmental Marketing Claims (Green Guides) and suggested stakeholders submit comments to FTC. Although the comment deadline on the Green Guides has passed, as reported in our May 11, 2023, blog item, FTC will hold a May 23, 2023, workshop on “Talking Trash: Recyclable Claims and the Green Guides.” In conjunction with the workshop, FTC will accept additional public comment until June 13, 2023, to accommodate those who wish to provide input on the topics discussed at the event.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Federal Trade Commission (FTC) announced on May 10, 2023, that it released the tentative agenda for its May 23, 2023, workshop on “Talking Trash: Recyclable Claims and the Green Guides.” The workshop will examine FTC’s guidance on “recyclable” advertising claims as part of its ongoing review of the Guides for Use of Environmental Marketing Claims (Green Guides). The workshop is free and open to the public, and pre-registration is not required. FTC states that the workshop will feature three panel discussions featuring a range of stakeholders. The panel discussions will focus on:

• The Current State of the Recycling Market and Claims: This session will include discussion of current conditions in the consumer recycling space, operation of recycling programs, markets for recyclable products, and advertising claims;
• Consumer Perception of Recycling Claims: This session will explore available evidence of how consumers understand “recyclable” advertising claims; and
• The Future of the Green Guides: This session will build on the previous sessions to analyze whether changes or updates are needed to ensure the Green Guides continue to provide accurate guidance to marketers on how to avoid making deceptive “recyclable” claims.

FTC will webcast the workshop on its website, http://www.ftc.gov. Registration is not required to watch the webcast. In conjunction with the workshop, FTC states that it is seeking additional public comment. The public will have until June 13, 2023, to submit comments to accommodate those who wish to provide input on the topics discussed at the event. More information on FTC’s review of the Green Guides is available in our December 16, 2022, memorandum. 

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By Lynn L. Bergeson and Carla N. Hutton
 
According to a May 6, 2023, Canada Gazette notice, the Minister of the Environment, pursuant to the Canadian Environmental Protection Act, 1999 (CEPA), intends to unmask the identities of 132 substances currently on Part 3 of the Domestic Substances List (DSL) in accordance with the Approach to disclose confidential information and promote transparency in chemicals. The annexed proposed Order includes the masked names and confidential accession numbers of the substances proposed for unmasking. The notice states that any person who objects to the unmasking of a substance subject to the notice should submit a masked name application for each substance to the Substances Management Information Line, including a masked name that complies with the Masked Name Regulations and the justification outlined in Section 7.2.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).
 
The notice states that any person who conducts commercial activities with a substance that they believe to be subject to the notice of intent may provide the Chemical Abstracts Service Registry Number^® (CAS RN^®) to the New Substances program for confirmation. Any person who objects to the unmasking of a substance subject to this notice should submit a masked name application for each substance. Canada will take comments into consideration during the development of the final Order. Comments on the proposed Order are due July 5, 2023.

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By Lynn L. Bergeson and Carla N. Hutton

The Northeast Waste Management Officials’ Association (NEWMOA) recently announced the release of its PFAS Prevention Model Act, which is intended to reduce the use of per- and polyfluoroalkyl substances (PFAS). According to NEWMOA, it worked with a group of state officials from the northeast to develop the draft legislation. NEWMOA states that the goals of the draft legislation are to:

• Reduce/eliminate the use of PFAS in consumer products to the extent feasible;
• Identify and implement source reduction programs;
• Ensure that the substitutes for PFAS in products are safer and that there are no regrettable substitutes;
• Coordinate product disclosure, labeling, bans, phase-outs, source reduction, and end-of-life collection on a multi-state basis;
• Help consumers identify products containing PFAS and learn how to properly handle them; and
• Provide regulated entities with regulatory certainty.

NEWMOA states that the model “provides a comprehensive framework to help jurisdictions develop more consistent approaches to addressing PFAS and PFAS-containing products” and that product manufacturers will “benefit from having more consistent requirements throughout the region and nationally.”

The draft legislation presents a menu of policy options for state policy makers to consider. The draft model includes provisions and concepts that reflect current efforts to reduce PFAS use and minimize PFAS releases. NEWMOA notes that “[t]he designers do not view the model as a set of provisions that must all be enacted together or at the same time. The model is designed to present a flexible set of concepts/options from which the jurisdiction policy makers can choose those that meet their jurisdictional priorities.” NEWMOA states that it is important that jurisdictions implement their efforts as consistently as possible for each option implemented, however.

NEWMOA states that it has an overarching goal of the “virtual elimination of the environmental releases of PFAS into the environment.” It welcomes comment on all aspects of the draft model legislation, and especially invites comment on:

• Key definitions, including the definitions for “Intentionally Added PFAS” and “PFAS Added Products”;
• The provisions in “Currently unavoidable uses of PFAS” in Section 6(c) of the draft model legislation; and
• The mechanisms for funding the costs of administering the provisions of the draft model legislation, including establishment of the Clearinghouse in Section 4.

Comments on the draft legislation are due June 29, 2023. NEWMOA will host a webinar on May 10, 2023, at 2:00 p.m. (EDT) to provide an overview of the draft legislation. Registration for the webinar is open.

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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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