This quarterly newsletter provides essential updates on litigation, regulatory, legislative and other notable developments involving chemicals of concern to business. Our primary focus continues to be matters affecting chemical substances which are the subject of regulatory activity or scrutiny by various federal and state government agencies and potential litigants. This includes emerging contaminants, including per- and polyfluoroalkyl substances (PFAS), as well as substances identified by the Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, or regulation.
Table of Contents
- Petitioners Alleged EPA's Granting of TSCA Section 21 Petition for Testing of 54 PFAS Was "in Reality" a Denial; Government Seeks Change of Venue
- Organizations Challenged TRI Reporting Exemptions for PFAS; EPA Announced Plan to Propose Elimination of Exemption
- FOIA Lawsuit Filed Seeking TSCA Section 8(e) Substantial Risk Reports
- Chemical Company Paid $600,000 Civil Penalty in Settlement of Alleged TSCA and EPCRA Violations
- FDA Pledged Response to 2016 Ortho-phthalates Petition After Organizations Filed Lawsuit
- EPA Prevailed in FOIA Suit Concerning TSCA Communication
- Defense Authorization Act Required DOD Actions on PFAS Testing, Remediation, and Risk Management
- EPA Extended TSCA Risk Management Rule's Compliance Date for PIP (3:1)-Containing Articles to October 2024
- EPA Published Update to TSCA Inventory
- EPA to Accept Feedback on TSCA Collaborative Research Program for New Chemical Reviews
- EPA Revised Guidelines for Making Corrections to the TSCA Inventory and Set April 26 Deadline for Submissions Under Old Guidelines
- EPA Released Mercury Inventory Reporting Compliance Guide
- Science Advisory Board to Consult with EPA on Improving the Science for Cumulative Impact Assessment
- EPA Released Draft IRIS Toxicological Review of PFHxA
- EPA Added Four PFAS to Toxics Release Inventory for 2022
- TSCA Risk Evaluation Update: HBCD and PV29 Revised Risk Determination, Asbestos Part 2 Scope, Fenceline Screening Approach, and Related Developments
- Biden Administration Prioritized Reduction in Procurement of PFAS-Containing Items
- EPA Updated New Approach Methods (NAMs) Work Plan
State Regulatory & Legislative Action
- New York
Petitioners Alleged EPA's Granting of TSCA Section 21 Petition for Testing of 54 PFAS Was "in Reality" a Denial; Government Seeks Change of Venue
On December 28, 2021, EPA announced that it had granted a TSCA Section 21 petition requesting that the Agency order health and environmental effects testing for 54 PFAS that the petitioners said were manufactured at a facility in North Carolina.1 EPA previously denied the petition in January 2021, but agreed to reconsider the denial in September 2021. In its December 2021 letter granting the petition, EPA said it "generally expects to take some immediate actions and to defer certain other actions pending the development of additional information that will inform future decision-making." EPA stated that most of the chemicals identified in the petition were covered by categories included in the Agency's National PFAS Testing Strategy released in October 2021. In particularly, EPA said the Agency's first test orders pursuant to the Testing Strategy would cover 30 of the 54 PFAS and that subsequent testing might cover nine of the 54 PFAS. EPA said it had decided it was not appropriate to require development of information on the remaining 15 PFAS because they did not fit the definition of PFAS used in the Testing Strategy, but the Agency also said it had determined there was "robust data" on some of them and that the Agency would be conducting "more in-depth analyses of the existing data." EPA's response also described EPA's plans with respect to mixtures studies and human studies. In addition, the letter explained EPA's conclusion that a "narrow subset" of the petitioners' requests fell outside TSCA Section 21 and/or EPA's statutory authority. On January 27, 2022, the petitioners and EPA filed a stipulation in the federal district court for the Northern District of California, where the petitioners' lawsuit challenging the January 2021 denial was pending.2 The petitioners contended that EPA's December 2021 response had in fact rejected "virtually all" of their requests. They therefore sought to amend their complaint. After the court granted this request, the petitioners filed an amended complaint on February 1, alleging that EPA's response to their petition failed to require testing on 47 of the 54 PFAS and provided no assurance that all requested studies would be conducted the remaining seven PFAS. The petitioners also alleged that EPA's response failed to address requests for certain studies and rejected other requests for testing, monitoring, and development of analytical standards and methods. On March 3, EPA filed its motion to transfer the case to the Eastern District of North Carolina, noting that all of the plaintiffs are located in the district or have offices there, and that the facility from which plaintiffs allege the discharges of PFAS occurred also is located in that district.
Organizations Challenged TRI Reporting Exemptions for PFAS; EPA Announced Plan to Propose Elimination of Exemption
On January 20, 2022, three plaintiffs-National PFAS Contamination Coalition, Sierra Club, and Union of Concerned Scientists-filed a lawsuit against EPA asserting that the Agency's rules adding PFAS to the Toxics Release Inventory (TRI) chemical list violated the statute that required their addition, as well as the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Administrative Procedure Act (APA).3 The plaintiffs alleged that EPA violated the National Defense Authorization Act for Fiscal Year 2020 (NDAA), which mandated the addition of the PFAS to the TRI list, by making the PFAS reporting obligations subject to exemptions in the EPCRA regulations for substances present in mixtures at de minimis concentrations and for facilities that qualify for an "alternative threshold" because they certify that reportable releases and disposals were 500 pounds or less combined. The plaintiffs contended that because the NDAA established a reporting threshold of 100 pounds for the PFAS, Congress did not intend for the EPCRA exemptions to apply since the exemptions generally do not apply to other chemicals with 100-pound thresholds. The plaintiffs also asserted that application of the exemptions in the PFAS listing rules violated EPCRA because the exemptions themselves-which were established in 1988 and 1994-exceeded EPA's authority under EPCRA. In addition, the plaintiffs contended that the PFAS listing rules were arbitrary and capricious because EPA premised the exemptions "on a view that relatively low concentrations or levels of manufacture, processing, use, and/or release will not present danger and do not need to be publicly disclosed, despite the known fact that PFAS are toxic at very low levels of exposure." Alternatively, the plaintiffs asserted that if EPA had discretion to apply the exemptions in the PFAS listing rules, the Agency violated APA procedural requirements by issuing the final rules without providing notice and an opportunity for public comment. On March 3, EPA announced that it planned to propose a rule in summer 2022 to make PFAS ineligible for the de minimis exemption. EPA said the proposal "would also make unavailable the de minimis exemption with regard to providing supplier notifications to downstream TRI facilities for PFAS and persistent, bioaccumulative, and toxic chemicals."
FOIA Lawsuit Filed Seeking TSCA Section 8(e) Substantial Risk Reports
On January 4, 2022, Public Employees for Environmental Responsibility (PEER) filed a Freedom of Information Act (FOIA) lawsuit to compel EPA to disclose documents related to submissions the Agency received since January 2019 pursuant to TSCA Section 8(e)'s requirement that manufacturers, distributors, and processors of chemical substances and mixtures submit information they obtain that "reasonably supports the conclusion" that a chemical substance of mixture "presents a substantial risk of injury to health or the environment."4 PEER alleged that its FOIA request was prompted by a November 2021 article in The Intercept, which reported that EPA had received 1,240 Section 8(e) submissions since January 2019 but had made only one of the reports available to the public. PEER's FOIA request asked for copies of all Section 8(e) submissions since January 2019 as well as documents related to EPA policies and decision-making regarding the posting of Section 8(e) information. On February 3, EPA announced that it had resumed publishing Section 8(e) notices to its ChemView database.5 EPA said it had begun publishing notices it had received since the procedure lapsed in 2019 due to resource limitations after the staff person responsible for publication of the notices to the ChemView database retired. The Agency plans to develop an automated process for publication of the notices.
Chemical Company Paid $600,000 Civil Penalty in Settlement of Alleged TSCA and EPCRA Violations
On December 15, 2021, EPA's Environmental Appeals Board ratified a consent agreement that resolved a chemical company's alleged violations of EPCRA TRI reporting requirements, TSCA Chemical Data Reporting (CDR) requirements, and TSCA restrictions on exports of elemental mercury. The consent agreement required the company to pay a $600,000 civil penalty.6 EPA found that the respondent failed to make TRI submissions for 17 chemicals at a New Jersey facility, failed to include 13 chemicals in its CDR submissions for the New Jersey facility and 16 chemicals in CDR submissions for a Kentucky facility, and exported between one and two pounds of elemental mercury on at least three occasions through the Kentucky facility to Canada, Taiwan, and India in violation of TSCA Section 12(c). EPA allocated the civil penalty as follows: $279,000 for the alleged TRI reporting violations; $273,000 for the alleged CDR violations; and $48,000 for the alleged violations of the mercury export ban.
FDA Pledged Response to 2016 Ortho-phthalates Petition After Organizations Filed Lawsuit
Eight organizations filed a lawsuit in December 2021 to compel the US Food and Drug Administration (FDA) to respond to a 2016 petition asking FDA to restrict the use of ortho-phthalate esters in food packaging and food processing materials.7 The complaint alleged that "[a] robust body of scientific evidence links human exposure to phthalates with serious harm to human health, including birth defects, infertility, miscarriage, and irreversible damage to the developing brain," and that "[i]ngestion of food and drinks contaminated by phthalates is the primary way that most people in the United States-including children-are exposed to most phthalates." The 2016 petition requested that FDA promulgate regulations prohibiting food contact uses of eight phthalates and that the agency remove five phthalates from FDA's list of "prior-sanctioned substances" that FDA approved for use in food or food packaging before September 1958. On February 9, 2022, FDA filed a motion for a temporary stay of all proceedings until the earlier of July 19, 2022 or the date on which FDA issues a final decision on the petition. FDA represented that it would issue a final decision by July 19.
EPA Prevailed in FOIA Suit Concerning TSCA Communications
On November 29, 2021, the Second Circuit Court of Appeals held in a split opinion that EPA records "reflecting deliberations about how to communicate the agency's policies to people outside the agency" qualified for the deliberative process privilege and could be shielded from disclosure under the Freedom of Information Act.8 At issue in the case were records related to the role of Dr. Nancy Beck, a former Deputy Assistant Administrator of EPA's Office of Chemical Safety and Pollution Prevention, in policymaking related to TSCA and pesticide matters. The Second Circuit reasoned that agencies exercise "policy-oriented judgment" when deciding how to communicate their policies. Therefore, otherwise deliberative agency records "that relate to and precede the agency's final communications decision" qualify for protection. In addition, the Second Circuit held that the deliberative process privilege can be invoked either with respect to a specific decision or a "specific decisionmaking process." The Second Circuit concluded that "messaging records" such as draft talking points for senior agency staff and internal discussions and draft responses related to inquiries from the press and members of Congress qualified for protection to the extent they related to the form and content of the communication (i.e., "what to say about a policy and how to formulate that message"). The Second Circuit also considered whether four "briefing documents" created to provide information to a senior manager in response to questions and comments on the role of epidemiology in human health risk assessments were predecisional and therefore protected from disclosure. The court held that a record is predecisional "if it relates to a specific decision or a specific decisionmaking process and was generated before the conclusion of that decision or process" (emphasis in original) but found that information was insufficient to determine if the briefing documents were predecisional. The dissenting judge concurred in the majority's analysis regarding the briefing documents but dissented from the majority opinion on the messaging records. He wrote that in some cases the withholding of messaging records under the deliberative process privilege is appropriate but said agencies should have to "make clear that the communications involved more than merely determining how to describe or spin policy decisions the agency had already made."
Defense Authorization Act Required DOD Actions on PFAS Testing, Remediation, and Risk Management
The National Defense Authorization Act for Fiscal Year 2022 (NDAA)-which President Biden signed on December 27, 2021-contained a subtitle devoted to PFAS.9 These provisions of the NDAA require the Department of Defense (DOD) to take the following actions:
- Establish a task force to address the effects of PFAS releases from DOD activities. The NDAA imposes four specific duties on the task force: monitoring the health aspects of PFAS exposures; identifying and funding procurement of an alternative to firefighting foam containing PFAS; coordinating within DOD to mitigate the effects of PFAS releases; and assessing "the perceptions of Congress and the public of the efforts of the Department of Defense with respect to mitigating the effects" of PFAS releases from DOD activities.
- Complete preliminary assessment and site inspection for PFAS at military installations and National Guard facilities identified as of March 31, 2021 as having a PFAS release, and prepare a report that includes a proposed schedule and cost estimates for completion of PFAS remediation at these sites.
- Prohibit the incineration of aqueous film forming foam (AFFF) containing PFAS, material contaminated by AFFF release, or filters or other PFAS-contaminated material from site remediation or water filtration until the Secretary of Defense issues guidance on destruction and disposal of PFAS and materials containing PFAS or EPA publishes a final rule regard destruction and disposal of such materials.
- Complete a review of DOD efforts to prevent or mitigate spills of AFFF and issue guidance on preventing and mitigation such spills.
- For areas located adjacent to and downgradient from military installations and certain other sites, publicly disclose final results of PFAS testing, as well as plans for testing.
- Complete a review of mutual support agreements with non-DOD entities, such as state and local entities, that involve fire suppression activities to assess how the agreements provide for the prevention and mitigation of risk related to spills of AFFF, and create guidance on requirements to include in mutual support agreements.
- Prepare a report within 60 days on the status of remediation efforts at 50 sites.
The NDAA also extends funding for the Agency for Toxic Substances and Disease Registry's study and assessment on health implications of PFAS contamination in drinking water and requires the Comptroller General of the United States to conduct a study of DOD's procurement of certain PFAS-containing items (furniture or floor waxes, car wax and car window treatments, cleaning products, and shoes and clothing).
EPA Extended TSCA Risk Management Rule's Compliance Date for PIP (3:1)-Containing Articles to October 2024
On March 3, 2022, EPA Administrator Michael Regan signed a final rule extending the compliance date until October 31, 2024 for a January 2021 TSCA risk management rule's prohibition on processing and distribution in commerce of certain articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)), as well as the PIP (3:1) used to make those articles.10 EPA promulgated the January 2021 rule as an expedited risk management rule pursuant to TSCA Section 6(h). Around the time of the original compliance date for the PIP (3:1) prohibition on March 8, 2021, EPA announced that it would exercise its discretion not to enforce the compliance date for up to 180 days due to concerns brought to the Agency's attention by industry stakeholders that the compliance date would disrupt supply chains for a wide variety of consumer and commercial products.11 In September 2021, EPA issued a final rule extending the compliance date to March 8, 202212 and in October 2021 proposed the extension to October 31, 2024.13 The final rule extending the compliance date to October 31, 2024 for the prohibition also extends the compliance date for related recordkeeping requirements. EPA's notice stated that it was further extending the compliance date to address "the hardships inadvertently created" by the January 2021 rule "due to impacted uses and supply chain challenges that were not communicated to EPA until after the rule was published," including concerns raised by the electronics and electrical manufacturing sector and their customers. EPA stated that the Agency found, based on comments provided by industry stakeholders regarding steps taken to identify alternatives or continue engaging in phase-outs, that there was a "compelling rationale" for the need to extend the compliance date to October 31, 2024.
EPA Published Update to TSCA Inventory
On March 4, 2022, EPA announced that an updated TSCA Inventory was available on the Agency's website.14 The Agency reported that the Inventory contains 86,631 chemical substances, 42,039 of which are active in US commerce. The updated Inventory also includes the specific chemical identities for 377 chemicals that lost their confidential status because the specific chemical identities were reported as non-confidential by at least one manufacturer during the 2012, 2016, and/or 2020 Chemical Data Reporting period. EPA plans to update the Inventory again in summer 2022.
EPA to Accept Feedback on TSCA Collaborative Research Program for New Chemical Reviews
On February 25, 2022, EPA announced in the Federal Register that the Agency would hold a virtual meeting on April 20 and 21, 2022 to collect input on its proposed TSCA New Chemicals Collaborative Research Program.15 In partnership with EPA's Office of Research and Development and other federal entities, the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop a collaborative research program focused on performing risk assessments for new chemical substances. EPA identified the following key areas of the proposed program:
- Updating OCSPP's approach to using data from structurally-similar chemicals to determine potential risks from new chemicals to increase the efficiency of new chemical rules while promoting use of best available data.
- Digitizing and consolidating information on chemicals that currently is available only in hard copy or in "disparate" TSCA databases and combining this information with publicly available sources.
- Updating and augmenting the models used for predicting a chemical's physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics, to provide a suite of models to be used for new chemicals assessments.
- Exploring ways to integrate and apply new approach methodologies (NAMs) in new chemical assessments to reduce use of animal testing.
- Developing a decision support tool that integrates the various information streams used for new chemical risk assessments to increase transparency and allow evaluation of consistency within and across chemistries.
EPA said it would provide more information about these key areas in a draft collaborative research plan that will be available in the docket by March 14. Written comments must be submitted by April 26, 2022.
EPA Revised Guidelines for Making Corrections to the TSCA Inventory and Set April 26 Deadline for Submissions Under Old Guidelines
On February 25, 2022, EPA published notice that it will no longer accept corrections of specific chemical identities for chemical substances submitted to EPA in 1978 using the original TSCA Inventory form.16 Effective May 31, 2022, EPA will revoke its 1980 Inventory Correction guidelines17 that provided a mechanism to request corrections of specific chemical identity errors. EPA notified the public that it must receive any final Inventory corrections under the 1980 guidance by April 26, 2022. After that date, a manufacturer that discovers an error in the specific chemical identity of a substance submitted for the original Inventory may need to submit a Premanufacture Notice or exemption notice if the substance is not listed on the Inventory. In the Federal Register notice, EPA stated that the Agency retained the authority to initiate corrections at its discretion. EPA also said revocation of the guidance did not impact its regular maintenance of the Inventory, which includes nomenclature updates and corrections of minor errors. EPA's notice explained that the Agency had not intended to establish a correction mechanism that would be "open-ended in time" and that it had become "increasingly evident that the 1980 guidelines have outlived the purpose for which they were intended." EPA cited the difficulty that original submitters and their successors now have with providing necessary documentation for correction requests, which EPA described as a "major concern and obstacle" to review and acceptance of correction requests. In addition, EPA mentioned potential misuse of the process to avoid submission of a PMN in cases where, for example, the original submission was correct but a change in the supply of a feedstock or in a performance requirement changes the manufacture of the original substance and results in a different specific chemical identity. As an additional basis for revoking the corrections policy, EPA cited numerous opportunities that manufacturers have had over the past 40 years to review their Inventory listings, discover good-faith errors, and request corrections (e.g., Inventory Update Rule/CDR submissions and the Notice of Activity reporting after the 2016 amendments to TSCA); however, it is unclear whether EPA has ever publicly invited submitters to use such periodic reporting requirements as an appropriate vehicle for correcting chemical nomenclature or identity issues related to the Initial Inventory.
EPA Released Mercury Inventory Reporting Compliance Guide
On February 22, 2022, EPA announced the release of an updated compliance guide on the triennial mercury inventory reporting requirements.18 The guide has been updated to "reflect the new requirement to report pre-assembled products that contain mercury-added components, such as a watch with a mercury-added battery," a change made after the Second Circuit invalidated an exemption for such products. Such pre-assembled products might be deeply embedded in a complex piece of equipment (such as a display light or an internal sensor), and the presence of mercury in such a component is highly unlikely to be known to an importer who is not the actual manufacturer of the equipment, thereby presenting compliance challenges under the revised requirements. EPA said the updated compliance guide "explains the requirements for manufacturers and importers to report to EPA information about the supply, use, and trade of mercury; provides an overview of the legal requirements; and describes how the Agency intends to use the information it collects. Diagrams and examples are provided to help companies determine whether they must report information about mercury to EPA." EPA also released the updated Mercury Electronic Reporting (MER) application, which can be accessed through the Central Data Exchange. The reporting deadline for calendar year 2021 is July 1, 2022.
Science Advisory Board to Consult with EPA on Improving the Science for Cumulative Impact Assessment
The EPA Science Advisory Board (SAB) scheduled a public meeting on March 2 and 7, 2022 to conduct a consultation with EPA on research needed to improve the state of the science supporting cumulative impact assessments.19 In advance of the meeting, EPA released an external review draft of a white paper that provides operational definitions of "cumulative impacts" and "cumulative impact assessment" and describes research gaps and barriers to implementing cumulative impact research at EPA. The white paper also makes recommendations for advancing cumulative impact research within ORD's six national research programs over the next four years, including the "Chemical Safety for Sustainability" (CSS) and "Health and Environmental Risk Assessment" (HERA) programs. The white paper is available here.
EPA Released Draft IRIS Toxicological Review of PFHxA
On February 2, 2022, EPA announced a 60-day public comment period on the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorohexanoic Acid (PFHxA) and Related Salts.20 The draft assessment (available here) derived a chronic oral reference dose (RfD) for noncancer effects (hepatic, hemapoietic, and developmental toxicity) of 5 x 10-4 mg/kg-day. A less-than-lifetime subchronic RfD of 5 x 10-4 mg/kg-day was also derived. There were no studies or models to support derivation of an RfD for inhalation exposure, and EPA concluded that there was inadequate information to assess carcinogenic potential for PFHxA by either oral or inhalation routes of exposure. EPA is preparing IRIS assessments for five PFAS (PFBA, PFHxS, PFHxA, PFNA, and PFDA). The draft PFHxA assessment is the second draft assessment EPA has released for public review.
EPA Added Four PFAS to Toxics Release Inventory for 2022
On January 24, 2022, EPA announced that four PFAS had been automatically added to the Toxics Release Inventory list pursuant to the requirements of the 2020 NDAA, which identified certain regulatory activities that trigger the addition of PFAS to the TRI list.21 Two substances-perfluorobutane sulfonic acid (PFBS) and perfluorobutane sulfonate-were added because EPA finalized toxicity values for them in April 2021.22 A third PFAS was added because EPA determined that it was designated "active" on the TSCA Inventory and was covered by the existing significant new use rule for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances finalized in July 2020.23 A fourth PFAS that meets the NDAA criteria was added after EPA completed review of a confidential business information claim relating to it. The four substances are on the TRI list effective January 1, 2022. Reports for calendar year 2022 data will be due by July 1, 2023.
TSCA Risk Evaluation Update: HBCD and PV29 Revised Risk Determination, Asbestos Part 2 Scope, Fenceline Screening Approach, and Related Developments
Over the past several months, EPA has taken actions to move forward on its plans to revisit the first 10 risk evaluations it completed in 2020 and 2021 as well as to establish the methodologies it will use to conduct future risk evaluations under TSCA Section 6.
HBCD: EPA's actions included the Agency's first issuance, in draft form, of a revised risk determination for one of the initial 10 chemical substances: cyclic aliphatic bromide cluster (HBCD).24 The revisions to the HBCD risk determination were made to incorporate two policy changes related to risk evaluations that EPA announced in June. First, EPA proposed to make its determination that HBCD presents an unreasonable risk to health and the environment "as a whole chemical substance" rather than making separate unreasonable risk determinations for each individual condition of use evaluated. In the original risk determination, six conditions of use were found to present an unreasonable risk, and six were found not to present an unreasonable risk. Second, EPA proposed to make explicit that the risk determination did not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination. Instead, EPA would consider PPE during the risk management phase. The draft revised risk determination for HBCD did not reflect a third policy change announced in June-EPA's decision to use a "fenceline screening" approach to assess whether the exclusion of exposure pathways in the original risk evaluations will lead to a failure to identify exposures to people located in communities near manufacturing and processing facilities. EPA, in its announcement of the policy changes, indicated that the Agency did not plan to undertake this screening-level approach for HBCD. The original comment period for the revised HBCD risk determination closed on February 14, 2022, but EPA reopened the comment period with a new deadline of March 4, 2022.25 It remains unclear how the "whole chemical approach," and policy with respect to PPE, will affect the terms of the risk mitigation rule that EPA will be required to promulgate on the basis of the final risk evaluation for HBCD.
Pigment Violet 29 (PV29): In the March 7, 2022 issue of the Federal Register, EPA published notice of the availability of its draft revision to the risk determination for Colour Index Pigment Violet 29.26 EPA proposed to find that PV29, "as a whole chemical substance," presents an unreasonable risk of injury to human health. As with HBCD, the draft revised risk determination does not reflect an assumption that workers always appropriately wear PPE. Comments on the draft revised determination are due by April 21, 2022.
Asbestos: EPA also released for public comment a draft scope for the second part of its risk evaluation of asbestos.27 EPA initially focused the risk evaluation for asbestos on chrysotile asbestos because it was the only asbestos fiber type that is currently imported, processed, or distributed in the US. However, after a November 2019 decision of the Ninth Circuit Court of Appeals28 that held that EPA should not have excluded legacy uses and associated disposals, EPA determined that it would issue the asbestos risk evaluations in two parts, with the second part focused on legacy uses and associated disposals. The draft scope indicated that EPA intends to evaluate legacy uses and associated disposals or chrysotile asbestos, other types of asbestos fibers in addition to chrysotile, and conditions of use of asbestos in talc and talc-containing products. EPA will be looking at a wide range of uses, including construction and building materials, machinery and electronic articles, fillers and putties, toys, textiles and fabrics, aerospace applications, paints, and lawn and garden products. In addition, EPA plans to include fenceline analyses where appropriate to screen for potential effects, with emphasis on potentially exposed and susceptible subpopulations and environmental justice communities, followed by more in-depth analysis where warranted. In addition, Part 2 will not rely on assumptions regarding the use of PPE in workplace. The deadline for submission of comments on the draft scope is March 1, 2022 (extended from February 14, 2022).29
D4: In the March 7, 2022 issue of the Federal Register, EPA announced the availability of the final scope of the risk evaluation for octamethylcyclotetra-siloxane (D4), for which EPA granted a manufacturer request for risk evaluation in October 2020.30
Fenceline Screening: As mentioned above, EPA in June 2021 reversed an earlier policy decision not to assess air and water exposure pathways in the 10 initial risk evaluations and decided to undertake a fenceline screening level approach to determine whether there are potential risks to fenceline communities from air and/or water routes of exposure that were not previously assessed in seven of the first 10 risk evaluations (1-bromopropane (1-BP), n-methylpyrrolidone (NMP), methylene chloride, carbon tetrachloride, trichloroethylene, tetrachloroethylene, 1,4-dioxane). EPA also intends to use the screening level approach for future chemical substances that undergo Section 6 risk evaluations. In January 2022, EPA released its "Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0" (available here), which presents the proposed methodology for assessing potential air and water chemical exposures to fenceline communities. The draft screening methodology also presents the results of applying the screening methodology to the risk evaluations for 1-BP (air pathway), NMP (water pathway), and methylene chloride (air and water pathway). The three case studies included in the draft screening level approach identified additional risks for 1-BP and methylene chloride and no additional risks for NMP. EPA noted that these results were not final agency actions and would not be used as presented to support risk management actions. The Science Advisory Committee on Chemicals (SACC) will meet on March 15-17, 2022 to consider and review the draft.31
Miscellaneous: Other developments related to TSCA risk evaluations included EPA's notice of an April 19-21, 2022 SACC meeting for consideration and review of the draft TSCA Systematic Review Protocol, which documents specific systematic review approaches EPA uses for identifying and evaluating evidence for the hazard and exposure assessments supporting risk evaluations.32 The draft protocol is available here. EPA said the protocol responded to recommendations received from the National Academies of Sciences, Engineering, and Medicine. EPA also reopened the dockets for 20 chemicals designated in December 2019 as "high priority" substances for risk evaluations. The dockets will remain open until June 9, 2022. EPA invited the public to submit use, hazard, or exposure information to inform EPA's risk evaluation process. The list of dockets can be found here.
Biden Administration Prioritized Reduction in Procurement of PFAS-Containing Items
In December 2021, President Biden issued Executive Order 14057 on "Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability,"33 which set sustainability goals for federal government procurement that were primarily focused on reduction of greenhouse gas emissions but that also required agencies to purchase sustainable products and services identified by EPA "to the maximum extent practicable." The White House simultaneously published a memorandum that noted the executive order's requirements for sustainable acquisition and procurement, and directed agencies to "prioritize substitutes for products that contain [PFAS]."34 Moreover, the memorandum provided that agencies should avoid the procurement of "PFAS-containing covered items." Such "covered items" include PFAS-containing nonstick cookware or cooking utensils and upholstered furniture, carpets, and rugs that have been treated with stain-resistant coatings.35 In addition, the White House issued a Federal Sustainability Plan that included prioritization of the purchase of "sustainable products" (including products without added PFAS) as one of its "principles and goals."36 More recently, EPA published a webpage that compiles how private sector standards and ecolabels in EPA's "Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing"-which identify private sector environmental performance standards or ecolabels that "most effectively address the environmental impacts of products and service and are verified to be appropriate for federal procurement"-specifically address PFAS in various product categories.37 The PFAS webpage lists nine standards or ecolabels from the Recommendations that include criteria specifically focused on PFAS content. The product categories covered by the PFAS-related standards include carpet, flooring, furniture, interior latex paint, take-out service items, trash bags, adhesives, and certain construction materials. While the criteria in some of these standards pertain only to PFOS or PFOA, the certification criteria for at least five of the standards restrict a broader array of PFAS. EPA also released an update of the "Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing" that the Agency uses to assess the marketplace of more than 460 private sector standards and ecolabels to determine which to include in the Recommendations. The update increases the Framework's emphasis on chemical content of products. For more information on how the update does so and on the Biden administration's other related actions, see our February 28 Environmental Edgeblog post.
EPA Updated New Approach Methods (NAMs) Work Plan
In December 2021, EPA updated the Agency's "New Approach Methods Work Plan," which describes steps EPA plans to take to reduce the use of vertebrate animals for toxicity testing.38 The updated Work Plan sets forth near- and long-term strategies for achieving five objectives and the deliverables on which the Agency will focus through 2024. The five objectives are: (1) evaluate regulatory flexibility for accommodating the use of NAMs; (2) develop baselines and metrics for assessing progress; (3) establish scientific confidence in NAMs and demonstrate application to regulatory decisions; (4) develop NAMs to address scientific challenges and fill important information gaps; and (5) engage and communicate with stakeholders. EPA identified the following primary changes in the updated Work Plan:
- expansion of the species covered in the work plan to include all vertebrate animals to be consistent with TSCA;
- modified deliverables that provide revised timelines through 2024 that reflect the expansion of covered species and incorporate feedback received over the preceding years;
- updated scope of the US National Academies of Sciences, Engineering, and Medicine study to include a review of validation and scientific confidence frameworks for NAMs in addition to evaluating the variability and relevance of existing mammalian toxicity tests;
- two new case studies for building confidence and demonstrating application of NAMs; and
- a pilot study to develop NAMs training courses and materials for a broad range of stakeholders.
State Regulatory & Legislative Action
New York Enacted Bans on Flame Retardant Chemicals in Furniture, Mattresses, and Electronic Displays
On December 31, 2021, New York enacted the Family and Fire Fighter Protection Act, which will prohibit sale of upholstered furniture and mattresses containing flame retardant chemicals that are halogenated, organophosphorus, organonitrogen, or nanoscale chemicals.39 The law also will bar custom upholsterers from using components that contain the regulated chemicals. In addition, the law will prohibit sale of electronic displays containing an organohalogen flame retardant chemical in the enclosure or stand. The law also will require electronic display manufacturers to submit reports identifying flame retardants used in the enclosure or stand of the displays. The law originally provided that the furniture, mattress, and electronic display prohibitions would take effect on January 1, 2024, with the upholstery ban taking effect a year earlier, but in January 2022 amendments were adopted that extended the sales prohibitions' effective date to December 1, 2024 and the upholsterer prohibition effective date to December 1, 2025. As amended, the prohibitions apply where the regulated chemicals are present "[a]to or above levels set by [DEC] in regulation" or are "intentionally added." The law provides that sellers of covered products will not be found to have violated the law if they can show good-faith reliance on a manufacturer's certificate of compliance.
New York Law Requires Lead Warning for Certain Decorative Lighting Products
On November 30, 2021, New York Governor Kathy Hochul signed legislation that requires warning labels for "seasonal and decorative lighting products" containing an electrical cord casing in which lead is present in a quantity greater than 100 parts per million.40 The requirement applies to "portable, plug-connected, temporary-use lighting products and accessories that have a nominal 120-volt input voltage rating," which includes products such as holiday string lights, pre-lit artificial Christmas trees, and other pre-lit objects. Pursuant to an agreement between the legislature and the governor, the law was amended in February 24 to modify the penalty provision to clarify that penalties were applicable only to manufacturers and to reduce the maximum penalty to $500 (from $1,000).
*Margaret Barry contributed to this newsletter.
1. Press Release, EPA, EPA Grants Petition to Order Testing on Human Health Hazards of PFAS (Dec. 28, 2021).
2. Ctr. for Env't Health v. Regan, No. 4:21-cv-01535 (N.D. Cal.).
3. Nat'l PFAS Contamination Coal. v. EPA, No. 1:22-cv-00132 (D.D.C., filed Jan. 20, 2022).
4. Pub. Emps. for Env't Resp. v. EPA, No. 1:22-cv-00014 (D.D.C., filed Jan. 4, 2022).
5. Press Release, EPA, EPA Re-initiates Publication of Chemical Health and Safety Notices to ChemView, Enhancing Public Accessibility (Feb. 3, 2022).
6. In re Avantor Performance Materials, LLC, Docket Nos. TSCA-02-2022-9142, EPCRA-02-2022-9142 (EAB Dec. 15, 2021).
7. Env't Def. Fund v. U.S. Food & Drug Admin., No. 1:21-cv-03190 (D.D.C. Dec. 7, 2021).
8. Nat. Res. Def. Council v. EPA, No. 20-422 (2d Cir. Nov. 29, 2021).
9. Pub. L. No. 117-81, §§ 341–349, 135 Stat. 1541, 1640–50.
10. 87 Fed. Reg. 12984 (Mar. 8, 2022).
11. 86 Fed. Reg. 14398 (Mar. 16, 2021).
12. 86 Fed. Reg. 51823 (Sept. 17, 2021).
13. 86 Fed. Reg. 59684 (Oct. 28, 2021).
14. The updated Inventory is available here.
15. 87 Fed. Reg. 10784 (Feb. 25, 2022).
16. 87 Fed. Reg. 10781 (Feb. 25, 2022).
17. 45 Fed. Reg. 50544 (July 29, 1980).
18. Press Release, EPA, EPA Announces Updates to Resources on Mercury Inventory Reporting Rule (Feb. 22, 2022); EPA, EPA-740-B-22-001, Compliance Guide: Reporting Requirements for the Mercury Inventory of the Toxic Substances Control Act (Jan. 2022).
19. 87 Fed. Reg. 4886 (Jan. 31, 2022). The meeting's agenda also included discussion of recommendations from the SAB Work Group for Review of Science Supporting EPA Decisions with regard to SAB review of planned EPA actions and conducting a quality review of the draft SAB report, "Review of the Multi-Agency Radiation Survey and Site Investigation Manual, Revision 2."
20. 87 Fed. Reg. 5819 (Feb. 2, 2022).
21. Press Release, EPA, EPA Requires Reporting on Releases and Other Waste Management of Certain PFAS, Including PFBS (Jan. 24, 2022); see (Jan. 24, 2022); see 15 U.S.C. § 8921(c).
22. See News Release, EPA, EPA Releases Updated PFBS Toxicity Assessment After Rigorous Scientific Review (Apr. 8, 2021).
23. See 85 Fed. Reg. 45109 (July 27, 2020).
24. 86 Fed. Reg. 74082 (Dec. 29, 2021).
25. 87 Fed. Reg. 9047 (Feb. 17, 2022).
26. 87 Fed. Reg. 12690 (Mar. 7, 2022).
27. 86 Fed. Reg. 74088 (Dec. 29, 2021).
28. Safer Chemicals, Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019).
29. 87 Fed. Reg. 7833 (Feb. 10, 2022).
30. 87 Fed. Reg. 12696 (Mar. 7, 2022).
31. 87 Fed. Reg. 3294 (Jan. 21, 2022).
32. 86 Fed. Reg. 71891 (Dec. 20, 2021).
33. 86 Fed. Reg. 70935 (Dec. 13, 2021).
34. Memorandum from Acting Director, Office of Mgmt. & Budget et al. regarding Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability (Dec. 8, 2021).
35. These "covered item" restrictions build on requirements the National Defense Authorization Act for Fiscal Year 2021. Pub. L. No. 116-283, § 333, 134 Stat. 3388, 3531.
36. Federal Sustainability Plan, Office of Fed. Chief Sustainability Officer/CEQ (last visited Mar. 3, 2022).
37. How EPA's Recommended Standards and Ecolabels Address Per- and Polyfluoroalkyl Substances (PFAS), EPA (last updated Feb. 15, 2022); Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing, EPA (last updated Feb. 28, 2022).
38. EPA, EPA 600/X-21/209, New Approach Methods Work Plan (Dec. 2021).
39. 2022 N.Y. Laws ch. 11 and 2021 N.Y. Laws ch. 829 (codified at N.Y. Env't Conserv. Law §§ 37-1001 to 37-1013).
40. 2022 N.Y. Laws ch. 40 and 2021 N.Y. Laws ch. 634 (codified at N.Y. Gen. Bus. Law § 389-s).
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