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
 
The U.S. Environmental Protection Agency (EPA) announced on October 28, 2022, that it awarded $748,180 in research grant funding to three institutions for research to improve understanding of how people are exposed to per- and poly-fluoroalkyl substances (PFAS) in several communities throughout the country. EPA states that there is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects. According to EPA, more data are needed to measure the nature and levels of PFAS in homes and food to understand pathways for human exposure and risk mitigation.
 
The following institutions are receiving awards:

• Silent Spring Institute, Newton, Massachusetts, to measure PFAS in air and dust in homes and to evaluate associations between potential residential sources and PFAS occurrence at home. According to EPA, this research will enhance understanding of the contribution of residential pathways to PFAS exposures and improve the interpretation of PFAS biomonitoring data;
   
• Duke University, Durham, North Carolina, to determine how different sources of PFAS exposure, including PFAS in drinking water and in homes, contribute to levels measured in blood. EPA states that this study will address key questions on the most relevant PFAS exposure pathways for the general U.S. population; and
   
• Emory University, Atlanta, Georgia, to develop a standardized, validated, scientific protocol to measure levels of a targeted set of PFAS in the home. According to EPA, data collected from home samples will be compared to data collected from PFAS in blood to help identify residential sources of PFAS measured in people’s blood.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) released a report on October 19, 2022, entitled “Persistent Chemicals: EPA Should Use New Data to Analyze the Demographics of Communities with PFAS in Their Drinking Water.” The Congressional requesters asked GAO to examine per- and polyfluoroalkyl substances (PFAS) contamination in drinking water and related state actions. GAO’s report examines what recent data from selected states show about the occurrence of PFAS in drinking water; the demographic characteristics of communities in selected states with and without PFAS in their drinking water; and factors that influenced states’ decisions to test and develop standards or guidance for PFAS in drinking water. GAO states that recent drinking water data from six selected states show that at least 18 percent of the states’ 5,300 total water systems had at least two PFAS -- perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) --above the U.S. Environmental Protection Agency’s (EPA) 2022 interim revised health advisory levels. GAO found that 978 water systems had the two PFAS at or above EPA’s minimum reporting level of 4 parts per trillion (ppt), the lowest level reliably quantified by most laboratories, and above EPA’s health advisory levels. The demographic characteristics of communities with PFAS in their drinking water varied in the states GAO examined. GAO states that according to EPA officials, EPA does not currently have information to determine the extent to which disadvantaged communities are exposed to PFAS in drinking water nationally; EPA plans to collect comprehensive nationwide data, however.
 
GAO states that according to state officials, public health and PFAS contamination concerns influenced some states’ decisions to test and develop enforceable standards or nonenforceable guidance for PFAS in drinking water. As of July 2022, six states set standards and were influenced to do so by public health concerns. When the states set standards, the levels they set were more stringent than EPA’s 2016 lifetime health advisory levels. Fourteen additional states developed guidance or began developing standards because of PFAS contamination.
 
GAO recommends that EPA conduct a nationwide analysis using comprehensive data to determine the demographic characteristics of communities with PFAS in their drinking water. EPA agreed with the recommendation.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 28, 2022, the Biden Administration submitted to Congress President Biden’s budget for fiscal year (FY) 2023. According to the U.S. Environmental Protection Agency’s (EPA) March 28, 2022, press release, the budget makes critical investments, including:

• Strengthening EPA’s Commitment and Ability to Implement Toxic Substances Control Act (TSCA) Successfully: The budget provides $124 million and 449 full time equivalents (FTE) for TSCA efforts “to deliver on the promises made to the American people by the bipartisan Lautenberg Act.” According to the budget, “[t]hese resources will support EPA-initiated chemical risk evaluations and protective regulations in accordance with statutory timelines.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: PFAS are a group of man-made chemicals that threaten the health and safety of communities across the United States. As part of the President’s commitment to tackling PFAS pollution, the budget provides approximately $126 million in FY 2023 for EPA to increase its understanding of human health and ecological effects of PFAS, restrict uses to prevent PFAS from entering the air, land, and water, and remediate PFAS that have been released into the environment. EPA states that it will continue to act on its PFAS Strategic Roadmap to safeguard communities from PFAS contamination.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Commercial Service, part of the U.S. Department of Commerce’s International Trade Administration, has begun registration for a webinar series designed to inform exporters and manufacturers about potential per- and polyfluoroalkyl substances (PFAS) risks affecting their business:
 
Part I: PFAS Basics: What you need to know
Wednesday, March 9, 2022, 1:00 p.m. (EST)
The first session will cover the PFAS basics, including where they are found, what health, environmental, and legal risks they present, how they are regulated, and how exporters and manufacturers can assess and manage their PFAS risks.
 
Part II: PFAS Technologies: Where are we & where are we going
Wednesday, April 6, 2022, 1:00 p.m. (EDT)
The second session will cover the current and future state of the many technologies needed to handle the increasing attention on PFAS.
 
Panelists will include:

• Alfredo Fernandez, Partner, Shipman & Goodwin LLP; and
• Brian Drollette, Managing Scientist, Exponent.

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By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA noted that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule followed a final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. More information on the proposed rule is available in our October 25, 2021, memorandum. It is not clear when OMB will complete its review or if the final rule will be published prior to the current March 8 compliance deadline.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a January 2022 enforcement alert entitled “Violations May Put Ski Wax Users at Risk from Illegal Perfluoroalkyl Substances.” According to the enforcement alert, EPA has identified several high-performance ski wax consumer products that contain perfluorinated chemicals that were not reviewed by EPA for health risks under the Toxic Substances Control Act (TSCA). EPA notes that these wax products are intended for use on sports equipment to enhance the performance of the equipment’s slick surfaces that are in contact with snow. The alert states that:

• EPA is concerned that recently identified TSCA violations may be putting skiers and wax applicators at risk for exposure to certain persistent and bioaccumulative chemicals; and
   
• EPA advises sellers of ski wax to ensure that the products they sell do not contain certain perfluorinated chemicals that are not on the TSCA Inventory or have prohibitions on their use in sporting goods.

The enforcement alert states that EPA identified several manufacturers, importers, and sellers that produced or sold ski wax products that included certain perfluorinated chemicals in violation of TSCA, which prohibits the manufacture, processing, or importation of a chemical that is not on the TSCA Inventory or otherwise exempt. TSCA requires anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to submit a premanufacture notice (PMN) at least 90 days prior to the manufacture, import, or processing of the chemical. According to the alert, review of the risks from per- and polyfluoroalkyl substances (PFAS) in ski waxes “is particularly important in light of the potential for ski wax technicians and recreational skiers who apply waxes to the skis to be exposed to PFAS from handling the waxes and from vapors released when the waxes are melted and applied to skis.” The alert notes that PFAS may enter the environment from the use of waxed skis and from the ski wax shavings scraped off during application.
 
The enforcement alert describes the following best practices for assessing whether a wax product contains a new chemical substance: (1) reviewing the product’s safety data sheet (SDS) and comparing the chemical substances against the TSCA Inventory; (2) contacting manufacturers and suppliers for additional chemical identity information where there is uncertainty regarding whether a chemical is on the TSCA Inventory; and (3) contacting EPA via the TSCA Hotline if it remains unclear whether a chemical substance is on the TSCA Inventory.
 
The enforcement alert provides information on EPA’s Audit Policy, under which regulated entities that voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. The alert states that most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system. According to the alert, many states also offer incentives for self-policing, and EPA suggests checking with the appropriate state agency for more information.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since January 1, 2011.
 
As reported in our June 11, 2021, memorandum, the fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts under the PFAS Strategic Roadmap. Comments on the proposed rule were due September 27, 2021.
 
EPA states that in response to public comments and additional information received during the comment period, it “is interested in convening an SBAR Panel.” The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. According to EPA, the Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, communities, or organizations to inform the Panel about the potential impacts of the proposed rule on small entities.
 
EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations must be received by February 16, 2022.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.

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