By Lynn L. Bergeson and Carla N. Hutton
 
On June 6, 2023, the Maine Senate passed LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). Passed by the House on June 1, 2023, the bill would postpone the January 1, 2023, reporting requirement for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). As reported in our February 17, 2023, memorandum, the Maine Department of Environmental Protection (MDEP) issued a proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions under the Act. Comments were due May 19, 2023.
 
The bill would extend the January 1, 2023, deadline for reporting the use of PFAS in products for sale to January 1, 2025, and would authorize reporting the amount of total organic fluorine if the amount of each PFAS compound is not known. The bill would allow the amount of PFAS to be reported based on information provided by a supplier rather than testing. It clarifies the packaging exemption under the law regulating PFAS in products, exempts from the reporting requirements manufacturers that employ 25 or fewer people, clarifies that the requirements and prohibitions of PFAS in products do not apply to used products or used product components, and makes other technical clarifications to PFAS reporting requirements. The changes made by the bill to the law regulating PFAS in products would be made retroactive to January 1, 2023.
 
Governor Janet Mills (D) has ten days (not counting Sundays) to sign or veto the bill. If Mills does not sign the bill and the legislature is still in session, after ten days, the bill will become law as if she signed it. Mills is reportedly expected to sign the bill.

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Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Bergeson & Campbell, P.C. (B&C^®) and its global consulting affiliate The Acta Group (Acta^®) have prepared this 20-page memorandum for your consideration. It offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.

We hope this information is helpful. We would be pleased to provide additional information and assist with PFAS-related scientific, regulatory, or legal questions that you may have.

Download a PDF of this memorandum

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including per- and polyfluoroalkyl substances (PFAS). GAO states that implementing the following three priority recommendations in this area, such as by establishing an ongoing process to assess the resources required to complete successfully Integrated Risk Information System (IRIS) chemical assessments, would improve EPA’s ability to prepare and issue the assessments:

• To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to reevaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in the report and ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database. According to GAO, as of February 2023, officials from ORD’s Chemical and Pollutant Assessment Division (CPAD) had conducted an analysis of the resources needed to produce chemical assessments, including IRIS assessments and Provisional Peer-Reviewed Toxicity Values. The analysis concluded by noting that CPAD is under-resourced and expects to experience a continued increase in its workload in coming years, thereby worsening the gap between what EPA offices need and what CPAD is able to produce. GAO states that CPAD’s analysis did not identify specific metrics for assessing the effectiveness of EPA’s staff recruitment and retention strategies or whether current resource allocations are helping CPAD meet the targets established in various EPA strategic action plans. GAO will keep the recommendation open until CPAD updates its analysis to include more specific metrics, which will help EPA determine the effectiveness of its recruitment and retention strategies.
   
• To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders. According to GAO, as of March 2023, EPA officials were considering ways to provide additional documentation to help stakeholders better understand the timeframes for completing IRIS assessments. GAO “encourage[s] EPA to provide its program offices with documentation of how long it takes to complete each of these different types of assessments to reduce uncertainty for stakeholders with significant interests in IRIS assessments.”
   
• The EPA Administrator should include in ORD’s strategic plan (or subsidiary strategic plans) identification of EPA’s universe of chemical assessment needs; how the IRIS program is being resourced to meet user needs; and specific implementation steps that indicate how IRIS will achieve the plan’s objectives, such as specific metrics to define progress in meeting user needs. GAO states that it will keep this recommendation open until CPAD updates its analysis to include such specific metrics and more information is available for GAO to determine the extent to which EPA management has used CPAD’s analysis to balance its workload with available resources. This would ensure EPA and CPAD can better identify and meet user needs.

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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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