The Chemical Compound—February 2021
This quarterly newsletter provides updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our primary focus continues to be on chemical substances which are the subject of regulatory activity or scrutiny by various government agencies and potential litigants. This includes emerging contaminants 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. We hope you find this publication informative, and we welcome your feedback on chemicals of interest to your organization.
Table of Contents
- Federal Court Granted Biden EPA's Request to Vacate Transparency-in-Science Rule
- EPA Ordered to Amend CDR Rule to Collect Asbestos Information
- EPA Denied New Petition to Prohibit Fluoridation After Court Declined to Reconsider Order Holding Challenge to Denial of Original Petition in Abeyance
- New Lawsuits Filed Challenging Final Risk Evaluations and DecaBDE Risk Management Rule
- Opening Briefs Filed in Challenges to Methylene Chloride Risk Evaluation
- Defense Bill Contained PFAS, Sustainable Chemistry Provisions
- Trump EPA Finalized Transparency-in-Science Rule, but Rule Set for Review by Biden EPA and in Court
- EPA Published Final Risk Management Rules for Five Persistent, Bioaccumulative, and Toxic Substances; Biden Administration to Review
- EPA Proposed Amendments to TSCA Fees Rule
- EPA Issued Final Guidance on Compliance with SNUR Requirements for Imported Articles with Surface Coatings Containing LCPFAC Substances
- "Compelling" Technical Concerns Lead to Two-Month Extension of CDR Submission Period
- As Trump Administration Wound Down, EPA Completed First 10 Risk Evaluations
- Trump EPA Withdrew Three Obama-Era Proposed Risk Management Rules
- EPA Issued Test Orders to Collect Additional Data on Nine Substances Undergoing Risk Evaluation
- EPA Released Draft Scopes for Manufacturer-Requested Evaluations of Phthalates
- EPA Considering Manufacturer Request for Risk Evaluation of Fragrance Ingredients
- EPA Denied Petition Seeking Testing for 54 PFAS at North Carolina Facility
- EPA and OSHA Enter Agreement for Coordination in New Chemicals Program
- Compliance Advisory Affirmed that Renewable Fuels and Fuel Additives Are Subject to TSCA
- GAO Report on IRIS Program Recommended Measures to Improve Program's Management
- Outgoing Trump EPA Announced PFAS Actions
Federal Court Granted Biden EPA's Request to Vacate Transparency-in-Science Rule
On January 6, 2021, EPA published its final rule on "Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information Rule."1 In his Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis signed on January 20, President Biden identified this rule as one EPA must review and, "as appropriate and consistent with applicable law," consider proposing its suspension, revision, or rescission.2 It also was reported that Congress might seek to use the Congressional Review Act to eliminate this rule.3 Major features of the rule included: (1) a requirement that for significant regulatory actions or development of influential scientific information, EPA will give greater consideration to "pivotal science" studies for which the underlying dose-response data are available in a manner sufficient for independent validation; (2) establishment of an "overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information"; (3) a requirement that EPA clearly identify all science that serves as the basis for significant regulatory action; (4) requirements for independent peer review of pivotal science; and (5) criteria for case-by-case exemptions from the rule's requirements.
The rule faced legal challenges by 18 states and four local governments in the federal district court for the Southern District of New York,4 and by environmental groups in the District of Montana.5 The states' complaint asserted that the final rule exceeded EPA's statutory authority, was in conflict with EPA's obligations under substantive environmental statutes, and was arbitrary and capricious. The states and local governments also claimed that EPA acted illegally by making the rule effective immediately. The environmental groups also contended that the rule exceeded EPA's authority and that EPA could not evade the Administrative Procedure Act's requirement for a 30-day delay in the effective date.
On January 27, the Montana federal court issued an order finding that EPA unlawfully made the rule effective immediately; the court delayed the effective date until February 5.6 The court was not persuaded by EPA's arguments that the rule could be effective immediately because it governed EPA's internal procedures or because the rule's "goals of ensuring transparency and consistency" are "crucial for ensuring confidence in EPA decision-making." The court further indicated that because the rule was "substantive" and not procedural, it was questionable whether EPA had authority to promulgate it under the Federal Housekeeping Statute. On January 31, EPA moved to vacate and remand the rule on the basis that the court's conclusion that the rule was substantive removed EPA's sole source of authority for adopting it. On February 1, the court granted the request for vacatur and remand.
EPA Ordered to Amend CDR Rule to Collect Asbestos Information
In December 2020, the federal district court for the Northern District of California ordered EPA to revise its Chemical Data Reporting (CDR) rule to address "information-gathering deficiencies" related to the Agency's collection of information about asbestos.7 The court—which was reviewing EPA's denial of petitions for rulemaking under Section 21 of TSCA—found that EPA had failed to collect "all reasonably available information concerning the risks posed by asbestos conditions of use" by declining to eliminate "loopholes" in the CDR rule. The court said the loopholes prevented EPA from receiving information about asbestos-containing articles, about asbestos impurities in products, and about asbestos processing. The court held that EPA's unwillingness to collect information it was authorized to collect "runs contrary to its obligation to collect reasonably available information to inform and facilitate its regulatory obligations under TSCA," including the preparation of the risk evaluation for asbestos.
EPA Denied New Petition to Prohibit Fluoridation After Court Declined to Reconsider Order Holding Challenge to Denial of Original Petition in Abeyance
On January 13, 2021, the federal district court for the Northern District of California denied EPA's request to reconsider its earlier decision to hold in abeyance a case challenging EPA's 2017 denial of a TSCA Section 21 petition seeking to compel EPA to act under TSCA to prohibit fluoridation of drinking water. The court had held the case in abeyance to allow the plaintiffs to a submit a new petition supported by the new evidence they had presented at the trial. The court also indicated that the plaintiffs needed to address "serious standing issues." In its January 13 order, the court rejected EPA's contention that the court had erred by not dismissing the lawsuit for lack of jurisdiction. The court did, however, grant EPA's request to amend the earlier order to require that the plaintiffs seek leave to amend their complaint should EPA deny the new rulemaking petition.8 The court indicated that the plaintiffs' more recent submissions had not assuaged its concerns about standing.
On January 19, 2021, EPA denied the new petition, citing the discretion accorded to the Agency's decision on whether to reopen the administrative record and reconsider its denial of the original petition.9 EPA stated that it was "exercising its discretion to allocate its resources to most effectively implement TSCA requirements, including significant new requirements from the 2016 amendments." EPA further found that the evidence submitted with the supplemental petition for evaluating the risk of neurotoxic effects from exposure to fluoride was insufficient for EPA to reach an informed risk determination.
New Lawsuits Filed Challenging Final Risk Evaluations and DecaBDE Risk Management Rule
In December 2020, two additional petitions for review were filed in federal courts of appeal—one in the Ninth Circuit and one in the DC Circuit—challenging EPA's final risk evaluation of cyclic aliphatic bromide cluster (HBCD).10 After the DC Circuit granted EPA's unopposed motion to transfer, the Ninth Circuit consolidated the two petitions with a third case filed in October and granted a request to set March 30, 2021 as the due date for opening briefs.11 The petitioners challenge EPA's conclusions that HBCD does not pose an unreasonable risk to human health and the environment under certain conditions of use.
Petitioners have also filed proceedings to challenge the final risk evaluations for asbestos12 and 1,4-dioxane.13 In addition, on January 27, 2021, Alaska Community Action on Toxics filed a petition for review in the Ninth Circuit challenging EPA's risk management rule for decabromodiphenyl ether (decaBDE), one of the persistent, bioaccumulative, and toxic substances for which EPA promulgated a risk management rule using the expedited procedures of Section 6(h).14
Opening Briefs Filed in Challenges to Methylene Chloride Risk Evaluation
The Ninth Circuit also is hearing consolidated proceedings challenging EPA's risk evaluation for methylene chloride after the Second Circuit granted EPA's request to transfer a proceeding filed by New York, other states, the District of Columbia, and New York City.15 Opening briefs were filed on January 25, 2021. The states and localities' brief argued that EPA failed to analyze significant exposure pathways, improperly considered regulatory protections under other statutes, and failed to comply with TSCA's mandate to consider risks posed to susceptible and vulnerable populations. The brief also contended that the findings that six conditions of use did not present an unreasonable risk were not supported by substantial evidence. In addition, the brief raised the issue of whether EPA violated TSCA by evaluating risks on a use-by-use basis rather than "comprehensively and holistically." The other brief, filed by environmental and labor groups, argued that EPA violated TSCA and acted arbitrarily by excluding releases to the environment from the risk evaluation's scope and by failing to consider risks to some potentially exposed and susceptible populations such as communities near methylene chloride-emitting facilities and genetically susceptible subpopulations. In addition, the brief argued that EPA violated TSCA by assuming workers would use and be protected by personal protective equipment. The brief also contended that EPA failed to explain differences between its estimates of carcinogenicity and estimates in past assessments, and failed to account for people's exposure to methylene chloride in more than one way. The Biden Administration has indicated that it will review the final risk evaluation for methylene chloride.16
Defense Bill Contained PFAS, Sustainable Chemistry Provisions
On January 1, 2021, the Senate voted to override President Trump's veto of the National Defense Authorization Act for Fiscal Year 2021 (2021 NDAA),17 four days after the House of Representatives voted to override the veto. The 2021 NDAA contains a number of provisions addressing per- and polyfluoroalkyl substances (PFAS), including a provision requiring the establishment of an interagency working group to coordinate federal activities—and to develop a strategic plan—related to PFAS research and development. The 2021 NDAA also bars the Department of Defense from procuring PFOS- or PFOA-containing nonstick cookware or cooking utensils or upholstered furniture, carpets, and rugs that have been treated with stain-resistant coatings. In addition, the legislation provides that the Department of Defense shall fund grants for development of alternatives to PFAS-containing firefighting foams. The law also establishes a program to conduct a study and develop recommendations to protect firefighters from exposure to PFAS through personal protective equipment. Another provision requires the Department of Defense to provide notifications to agricultural operations located within one mile downgradient of a military or National Guard facility where certain PFAS have been detected in groundwater at the agricultural operations, the PFAS have been hydrologically linked to a local agricultural or drinking water sources, and the groundwater contamination is suspected or known to be the result of the use of PFAS at the military or National Guard facility. The 2021 NDAA also increased the funding for a Centers for Disease Control study on the health implications of PFAS in drinking water. In addition, the legislation included a subtitle on "Sustainable Chemistry" that requires the convening of an interagency body to coordinate federal programs and activities in support of sustainable chemistry. The interagency entity is tasked with, among other things, the development of a consensus definition of "sustainable chemistry" to guide other activities under the subtitle. Other activities include development of partnerships with universities, nongovernmental organizations, consortia, and companies to "create collaborative sustainable chemistry research, development, demonstration, technology transfer, and commercialization programs," and to "train students and retrain professional scientists, engineers, and others involved in materials specification on the use of sustainable chemistry concepts and strategies." The law also specifies activities that federal agencies should pursue in support of sustainable chemistry.
EPA Published Final Risk Management Rules for Five Persistent, Bioaccumulative, and Toxic Substances; Biden Administration to Review
On January 6, 2021, EPA published final risk management rules for five persistent, bioaccumulative, and toxic (PBT) substances that EPA identified for expedited action in 2016 under Section 6(h) of TSCA.18 The five substances are decaBDE; phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). Key elements of the proposed rules include:
- DecaBDE: EPA prohibited the manufacture (including import), processing, and distribution in commerce of decaBDE and products containing decaBDE, a flame retardant. For certain uses—including curtains in the hospitality industry, parts for new aerospace vehicles, and wire and cable insulation in nuclear generation facilities—EPA allowed the uses to continue for specified periods of time. The final rule generally provides that products containing decaBDE that were produced and already in end users' possession may remain in use for the remainder of their service lives.
- PIP (3:1): The final rule prohibits the processing and distribution in commerce of PIP (3:1)—a plasticizer, flame retardant, anti-wear additive, and anti-compressability additive—with exceptions for certain uses, including those in certain aeronautic and military applications. The final rule also requires that manufacturers, processors, and distributors of PIP (3:1) and products containing PIP (3:1) notify customers of TSCA's restrictions. In addition, the final rule prohibits releases to water.
- 2,4,6-TTBP: The final rule prohibits distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP at concentrations above 0.3% by weight in any container with a volume of less than 35 gallons. EPA intends these restrictions to prevent consumers and small businesses from using 2,4,6-TTBP as a fuel additive or fuel injector cleaner. EPA also prohibited the processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP, for use as an oil or lubricant additive in concentrations above 0.3% by weight regardless of container size.
- HCBD: In the final rule, EPA reversed course on HCBD, which it had proposed not to regulate because other statutes already addressed potential exposure. Instead, the final rule prohibits the manufacturing (including import), processing, and distribution in commerce of HCBD and HCBD-containing products or articles, except for the unintentional production of HCBD as a byproduct during the production of chlorinated solvents and the processing and distribution of the byproduct for burning as a waste fuel.
- PCTP: The final rule prohibits manufacture (including import), processing, and distribution in commerce of PCTP, which is a "peptizer" that makes rubber more amenable to processing, and products or articles containing PCTP unless PCTP concentrations are at or below 1% by weight.
The Biden-Harris transition included the five final rules, along with the 2019 proposed rule,19 in a non-exclusive list of rules that the Biden Administration will review in accordance with the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.20 On January 27, 2021, an environmental group filed a petition for review in the Ninth Circuit challenging EPA's risk management rule for decaBDE.21
EPA Proposed Amendments to TSCA Fees Rule
In January, EPA proposed amendments to the TSCA Fees Rule that follow through on the Agency's announcement in March 2020 that it would consider revisions to the rule to exempt certain manufacturers from the obligation to contribute to the costs of conducting EPA-initiated risk evaluations.22 The comment period is scheduled to close on February 25, 2021. Consistent with the March 2020 announcement, the proposed rule provides for fee obligation exemptions for manufacturers of chemical substances subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA also has proposed other exemptions for research and development activities; for entities manufacturing less than 2,500 pounds annually of a chemical subject to an EPA-initiated risk evaluation fee; and for manufacturers of chemical substances produced as a non-isolated intermediate. EPA proposed to require manufacturers to maintain certain records documenting their eligibility for the latter three exemption categories. The proposed rule also would require export-only manufacturers to contribute to fees for EPA-initiated risk evaluations. Other proposed changes include new fee categories for Bona Fide Intent to Manufacture or Import Notices and Notices of Commencement of Manufacture or Import, and an additional fee associated with test orders when the recipient of a test order elects to resubmit data if EPA determines the recipient did not comply with the order's requirements or the company determines that the submitted information was incomplete, inconsistent, or deficient. EPA also proposed a volume-based fee allocation for the fee for an EPA-initiated risk evaluation when manufacturers do not form a consortium to pay the fee, and proposed to change the payment approach for the costs of manufacturer-requested risk evaluations. In addition, EPA updated its estimated annual costs for implementation of TSCA Sections 4, 5, 6, 8, and 14 for 2022 through 2024, finding that total costs would be approximately $87.5 million each year.
EPA Issued Final Guidance on Compliance with SNUR Requirements for Imported Articles with Surface Coatings Containing LCPFAC Substances
On January 19, 2021, EPA issued the final version of a compliance guide for its July 2020 Significant New Use Rule (SNUR) for Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances.23 The SNUR—which took effect on September 25, 2020—instituted (among other things) a requirement for Significant New Use Notification at least 90 days before commencing import of certain LCPFAC substances as part of a surface coating on an article. The guidance document finalized on January 19 is intended to assist importers in determining whether articles they intend to import are covered by the SNUR and, if so, in understanding compliance obligations. The guide discusses what constitutes an "article" and a "surface coating," including by providing examples; discusses how importers can determine if they are subject to the SNUR; and summarizes the SNUR's notification requirements. The guidance also lists ongoing uses that are not subject to the SNUR. Although EPA released the guidance in final form, a Federal Register notice announcing the final guidance document has not been published, suggesting additional consideration inside EPA might be ongoing.
"Compelling" Technical Concerns Lead to Two-Month Extension of CDR Submission Period
The 2020 submission period for the Chemical Data Reporting rule closed on January 29, 2021, after EPA granted requests from the regulated community to extend the already-extended November 30, 2020 deadline.24 EPA cited "compelling concerns" raised by industry regarding technical issues with the electronic reporting system, including difficulties with bulk uploads, lack of access to the reporting tool due to a CDX system crash, and other issues with the reporting tool's features.
As Trump Administration Wound Down, EPA Completed First 10 Risk Evaluations
In the final three months of the Trump Administration, EPA issued seven final risk evaluations under Section 6(b) of TSCA. The Agency has now moved into the risk management phase for the initial 10 existing chemical substances, although the Biden Administration has said it will review the final risk evaluation for methylene chloride25 and also could decide to revisit other final risk evaluations. In addition, EPA had previously announced that the Agency would prepare a supplement to its risk evaluation for asbestos in order to consider legacy uses and associated disposals, as required by a 2019 Ninth Circuit decision. The risk evaluations completed since the last issue of the Chemical Compound were for the following chemical substances:
- C.I. Pigment Violet 29 (PV29): Notice of the availability of the final risk evaluation was published on January 21, 2021,26 less than three months after EPA released a revised draft of the evaluation.27 The final risk evaluation found no unreasonable risk to the environment, consumers, bystanders, or the general population, but did find that PV29 presents an unreasonable risk of injury to workers and occupational non-users for 10 of the 14 conditions of use considered. In the final risk evaluation, EPA concluded that plastic and rubber products (automobile plastics and industrial carpeting) did not present an unreasonable risk after preliminarily concluding in the revised draft that they could present an unreasonable risk. EPA concluded in the final evaluation that automobile paints and coatings containing PV29 do present an unreasonable after making a preliminary no-unreasonable-risk finding in the revised draft evaluation.
- 1,4-Dioxane: Notice of the availability of the final risk evaluation was published on January 8, 2021,28 less than two months after EPA issued a supplemental analysis that considered additional conditions of use for 1,4-dioxane as a by-product in consumer products, as well as an analysis of recreational activities in ambient/surface water as an exposure pathway.29 The final risk evaluation found no unreasonable risk to the environment or the general population from 1,4-dioxane in surface water and no unreasonable risk to consumers or bystanders from consumer products such as surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer where 1,4-dioxane is present as a byproduct. The final risk evaluation found that 13 conditions of use present an unreasonable risk to workers and occupational non-users from both short- and long-term inhalation and dermal exposure. On January 26, three environmental groups filed a petition for review in the Ninth Circuit challenging the final risk evaluation.30
- Asbestos: Notice of the availability of the final "Part 1" of the risk evaluation was published on January 4, 2021.31 EPA is preparing a draft scope for Part 2 of the evaluation, which will evaluate legacy uses and associated disposal. Part 1 found that all consumer uses of chrysotile asbestos present an unreasonable risk to consumers and bystanders. EPA also found that certain commercial uses of chrysotile asbestos present an unreasonable risk to workers and occupational non-users. The final evaluation found no unreasonable risk to the environment from any conditions of use. On January 26, public health groups, scientists, and doctors filed a petition for review in the Ninth Circuit challenging the final risk evaluation.32
- ·n-Methylpyrrolidone (NMP): Notice of the availability of the final risk evaluation was published on December 30, 2020.33 The risk evaluation identified one consumer use of NMP (in adhesives and sealants) that presents an unreasonable risk to human health and 25 commercial uses that present an unreasonable risk to the health of workers. The risk evaluation did not find an unreasonable risk to the environment or to the general population.
- Perchloroethylene: Notice of the availability of the final risk evaluation was published on December 18, 2020.34 The final risk evaluation found that 59 conditions of use present an unreasonable risk to human health, including all consumer uses and all but two occupational uses. The evaluation found no unreasonable risk to the environment.
- Trichloroethylene: Notice of the availability of the final risk evaluation was published on November 24, 2020.35 The risk evaluation found that 52 of the 54 conditions of use considered present unreasonable risks to workers, occupational-non-users, consumers, and bystanders. The only two uses found not to present an unreasonable risk are distribution in commerce and use in pepper spray. The evaluation found no unreasonable risk to the environment.
- Carbon tetrachloride: Notice of the availability of the final risk evaluation was published on November 4, 2020.36 The final risk evaluation found that carbon tetrachloride presents an unreasonable risk to workers and occupational non-users for 13 of the 15 conditions of use considered. There are no consumer uses of carbon tetrachloride, and EPA found no unreasonable risk to the environment. On January 26, 2021, the Halogenated Solvents Industry Alliance (HSIA) submitted a "request for correction" under the Information Quality Act, seeking changes in the risk evaluation to address "two key deficiencies": (1) a failure to incorporate "longstanding workplace practices" required by EPA under the Clean Air Act, and (2) use of a "linear non-threshold model coupled with an assumption that the principal study relied upon did not produce a no-observed-adverse-effect level." HSIA contended that these "errors" resulted in "inaccurate findings" and provided "erroneous starting points for risk management."
TSCA requires that EPA issue a proposed risk management rule within one year of the final risk evaluation and a final risk management rule within two years.37 Extension of these deadlines would require EPA to provide "adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final rule without additional information regarding the chemical substance."38
Trump EPA Withdrew Three Obama-Era Proposed Risk Management Rules
On January 15, 2021, EPA published notice that it was officially terminating proposed risk management rules published at the end of the Obama Administration for TCE, NMP, and methylene chloride.39 Two of the now-withdrawn proposed rules would have regulated uses of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities and for vapor degreasing.40 The third rule proposed to regulate the use of NMP and methylene chloride for commercial and consumer paint and coating removal.41 With respect to methylene chloride, EPA only withdrew the portions of the proposed rule that addressed commercial uses because the Agency promulgated a final rule in 2019 addressing consumer uses. EPA stated that it was withdrawing the three proposed rules because the Agency has completed risk evaluations for the three substances and initiated development of risk management rules that will cover the conditions of use addressed in the proposed rules, along with additional conditions of use found to present unreasonable risks. EPA indicated that retention of the proposed rules was therefore unnecessary and "could be duplicative or could create unnecessary public confusion about the extent and nature of the regulatory actions the Agency intends to take to address unreasonable risks identified for these chemical substances."
EPA Issued Test Orders to Collect Additional Data on Nine Substances Undergoing Risk Evaluation
On January 15, 2021, EPA announced that it had issued test orders for nine of the 20 High-Priority Substances for which the Agency is currently conducting risk evaluations. The substances subject to the test orders are seven chlorinated solvents and two flame retardants.[[N:Press Release, EPA, EPA Issues Test Orders for Nine Chemicals Undergoing Risk Evaluation under TSCA (Jan. 15, 2021). The nine substances are 1,1,2-trichloroethane, 1,1-dichloroethane, 1,2-dichloroethane, 1,2-dichloropropane, trans-1,2-dichloroethylene, o-dichlorobenzene, p-dichlorobenzene, 4,4'-(1-methylethylidene)bis[2,6-dibromophenol] (TBBPA), and phosphoric acid, triphenyl ester (TPP).]] EPA said the test orders require development and submittal of information on environmental hazard and inhalation and dermal exposures for workers that is necessary for the evaluation of the chemicals. Links to the test orders are available here.
EPA Released Draft Scopes for Manufacturer-Requested Evaluations of Phthalates
On November 27, 2020, EPA published notices of the availability of draft scopes for manufacturer-requested risk evaluations for di-isodecyl phthalate (DIDP)42 and di-isononyl phthalate (DINP).43 For both DIDP and DINP, the draft scopes indicated that EPA would evaluate inhalation exposure for workers and occupational non-users and dermal exposures for workers in connection with the manufacturing, processing, use, or disposal of DIDP. EPA also plans to analyze dermal exposure for workers and occupational non-users to mists and dust that deposit on surfaces. In addition, EPA plans to consider consumer and bystander exposures to a number of products containing DIDP or DINP, and also to consider general population exposures and the exposure for aquatic and terrestrial receptors in the environment. The comment period on the draft scopes closed on January 11, 2021.
EPA Considering Manufacturer Request for Risk Evaluation of Fragrance Ingredients
On November 20, 2020, EPA received a manufacturer request for a risk evaluation for four chemical substances as a category—the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE).44 The four substances, two of which are PBT chemicals, are used as fragrance ingredients in consumer products and were included in the 2014 Update to the TSCA Work Plan. Consumer products that potentially contain OTNE include bath and shower products, personal care products, and laundry products such as fabric softeners and detergents. In 2016, manufacturers requested that the two PBT chemicals be removed from consideration for the expedited risk management process under TSCA Section 6(h) and instead undergo a risk evaluation. In its letter acknowledging receipt of the manufacturer's request, EPA said it would open a public comment period of at least 45 days on the request no later than February 16, 2021.
EPA Denied Petition Seeking Testing for 54 PFAS at North Carolina Facility
On January 22, 2021, EPA published notice of its denial of an October 2020 petition submitted by six environmental groups pursuant to TSCA Section 21 requesting that the Agency require health and environmental effects testing of 54 PFAS they alleged were manufactured at a chemical production facility in Fayetteville, North Carolina. EPA found that the petitioners had not met their burden under Section 21.45 EPA concluded that the petitioners did not provide facts necessary for EPA to determine for each of the 54 PFAS that "existing information and experience" were insufficient. EPA further found that the petitioners did not demonstrate that testing was necessary, noting that they failed to address ongoing testing and data collection for some of the PFAS. In addition, EPA indicated that the petitioners had acknowledged similarities in the 54 PFAS but had not explored a streamlined testing approach as called for by TSCA Section 4(h)(1)(B)(ii).
EPA and OSHA Enter Agreement for Coordination in New Chemicals Program
On January 12, 2021, EPA and the Occupational Safety and Health Administration (OSHA) announced that they had entered into a memorandum of understanding (MOU) to aid the two agencies in fulfilling their obligations in the TSCA Section 5 new chemical program.46 Section 5 requires EPA to consult with OSHA prior to imposing prohibitions or other restrictions on new chemicals to address workplace exposures.47 The MOU establishes guidelines for communications between the agencies and provides for the establishment of frameworks for a formal consultation process under Section 5 as well as more informal communications. The MOU also sets parameters for the sharing of confidential business information.
Compliance Advisory Affirmed that Renewable Fuels and Fuel Additives Are Subject to TSCA
In December 2020, EPA issued a Compliance Advisory on "Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates."48 In the advisory, EPA indicates that it received inquiries from stakeholders regarding whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under Section 5. The advisory affirms that chemical substances used as fuels and fuel additives and distillates made from either petroleum or renewable sources are subject to TSCA. EPA advises that companies can submit a Bona Fide Intent to Manufacture or Import Notice to EPA if they have valid commercial intent to manufacture or import a renewable-sourced substance and are uncertain if the substance is listed on the TSCA Inventory. In response to such a notice, EPA will inform a company both of the substance's Inventory status and whether it is subject to regulation under TSCA Section 5.
GAO Report on IRIS Program Recommended Measures to Improve Program's Management
In December 2020, the US Government Accountability Office (GAO) issued a report on EPA's Integrated Risk Information System (IRIS) program, which conducts chemical assessments to inform EPA decision-making.49 Fifteen assessments are currently underway. The report made five recommendations for improvements in the IRIS program. First, GAO recommended that EPA provide more public information about the status of IRIS chemical assessments. The report also suggested that EPA Assistant Administrators and Regional Administrators provide guidance for EPA staff on criteria and information to apply when selecting chemicals to nominate for assessment, and that the Office of Research and Development (ORD) provide information about how it selects nominations for inclusion in the IRIS program. In addition, the report found that EPA should continue to evaluate ORD's recently instituted annual survey for soliciting nominations from program and regional offices; GAO said EPA should consider changes to ensure the survey facilitates collection of quality information; the report also recommended specific IRIS-focused elements that should be included in ORD's strategic plan. EPA partially agreed with two of the recommendations (regarding communication of the criteria for selecting nominations and including IRIS elements in the strategic plan), but disagreed with the other three recommendations. EPA indicated that it believed the Agency had already implemented the other recommended actions.
Outgoing Trump EPA Announced PFAS Actions
On January 19, 2021, EPA announced actions taken under its PFAS Action Plan.50 First, EPA announced it had issued final regulatory determinations under the Safe Drinking Water Act to regulate perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA).51 EPA said it would move forward with development of national primary drinking water regulations for PFOA and PFOS. Second, EPA announced that Administrator Wheeler had signed an advance notice of proposed rulemaking (ANPRM) seeking comment on whether EPA should use other statutory authorities to regulate PFOA and PFOS such as the Comprehensive Environmental Response, Compensation, and Liability Act and the Resource Conservation and Recovery Act.52 Third, EPA issued proposed revisions to the fifth Unregulated Contaminant Monitoring Rule that would require public water systems to collect national occurrence data for 29 PFAS and lithium.53 Fourth, EPA announced the release of a final toxicity assessment for perfluorobutane sulfonic acid (PFBS). The assessment provides toxicity values and information about the adverse effects of PFBS.54 Fifth, EPA announced steps it would take to address PFAS in wastewater, as detailed in the Effluent Guidelines Program Plan 14 (Plan 14) released earlier in January.55 Steps included in Plan 14 include a planned ANPRM to collect information about PFAS manufacturers and formulators to inform decisions on whether national effluent limitation guidelines should be developed to address PFAS discharges from their facilities. Sixth, EPA announced an anticipated draft report on coordination of PFAS research across the federal government. The Biden Administration may decide to retract and/or review some of these actions.
State Regulatory & Legislative Action
California to Propose Listing Tires Containing Zinc as Priority Products
On January 12, 2021, the California Department of Toxic Substances Control (DTSC) announced that it proposed to list Motor Vehicle Tires Containing Zinc as a Priority Product under the Safer Consumer Products program.56 DTSC initiated the process for the listing in response to a petition from the California Stormwater Quality Association, which cited findings that zinc frequently exceeds water quality standards in water bodies and that even low concentrations of zinc are potentially harmful to aquatic life. The petition asserted that reducing or eliminating zinc in tires would be the most cost-effective way of reducing zinc in stormwater. DTSC said it would issue a technical document explaining the rationale for its decision by the end of the first quarter of 2021, and that the agency would hold a public comment period and workshop prior to commencing the formal rulemaking process.
Court Declined to Stay New Jersey PFOA and PFOS Drinking Water Standards
In a one-page order, the Appellate Division of the New Jersey Superior Court on January 4, 2021 denied a motion to stay drinking water standards for PFOA and PFOS and related regulations adopted by the New Jersey Department of Environmental Protection in 2020.57
New York Law Would Ban TCE Uses
A bill signed on December 23, 2020 would ban use of TCE as a vapor degreaser, intermediate chemical, refrigerant, or extraction solvent, or in other manufacturing or industrial cleaning processes or uses beginning on December 31, 2021.58 Governor Andrew M. Cuomo indicated in an approval memorandum, however, that he and the legislature had agreed to amend the new law to address concerns regarding federal preemption and the availability of safe alternatives to TCE. The anticipated changes will delay the effective date and add a severability clause in case EPA action under TSCA preempts state regulation of one or more of the uses prohibited by New York's law.
New York Enacted Ban on PFAS-Containing Food Packaging
On December 2, 2020, Governor Cuomo signed legislation prohibiting distribution, sale, and offering for sale of food packaging containing intentionally added PFAS.59 The law takes effect on December 31, 2022. "Food packaging" is defined as "a package or packaging component that is intended for direct food contact and is comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers."
New York Banned Incineration of PFAS-Containing Firefighting Foams in Upstate City
On November 23, 2020, Governor Cuomo signed a bill that prohibited the disposal by incineration of aqueous film-forming foam (AFFF) containing PFAS in the City of Cohoes, located northeast of Albany.60 In the press release announcing the legislative ban, Governor Cuomo indicated that the State also would continue to advance comprehensive statewide measures to address emerging contaminants such as PFAS. The press release also described actions taken by DEC since 2019 to address the environmental impacts of AFFF incineration at a facility in Cohoes.
In Case Challenging Inaction on PFOA Rulemaking Petition, Pennsylvania Court Allowed Trimmed-Down Suit to Proceed
The Pennsylvania Commonwealth Court allowed Delaware Riverkeeper Network (DRN) to proceed with one count in its lawsuit to compel the Pennsylvania Department of Environmental Protection (PADEP) to respond to the Delaware Riverkeeper's 2017 petition requesting that PADEP and the Pennsylvania Environmental Quality Board set a maximum contaminant level for PFOA under the Pennsylvania Safe Drinking Water Act.61 Although PADEP officials recommended that the rulemaking petition be accepted for further review and indicated that PADEP would prepare a report on the petition by June 2018, PADEP did not prepare such a report, and the agencies have neither responded to the rulemaking petition nor pursued regulation of PFOA in drinking water. The court concluded that DRN did not state claims under the citizen suit provision of the Pennsylvania Safe Drinking Water Act or under the Pennsylvania Constitution's Environmental Rights Amendment. The court found, however, that a separate statute did require the agencies to respond to the petition and allowed DRN to proceed with a claim for declaratory relief based on that statute.
Washington Considering Draft Action Plan for PFAS
The comment period on Washington's Per- and Polyfluoroalkyl Substances Draft Chemical Action Plan closed on January 22, 2021.62 The draft plan contains four categories of recommendations to address PFAS:
- Ensure drinking water is safe.
- Manage environmental PFAS contamination.
- Reduce PFAS in products.
- Understand and manage PFAS in waste.
In addition, the draft plan reports on other actions the State is taking, including consideration of a state action level for PFAS in drinking water, restrictions on PFAS-containing firefighting foam, and implementation of a prohibition on PFAS in plant fiber-based food packaging.
Wisconsin Issued Action Plan to Address PFAS Contamination
On December 16, 2020, the Wisconsin PFAS Action Council released the Wisconsin PFAS Action Plan, which was described as "a blueprint for action."63 The plan recommends 25 actions, organized into eight themes:
- Standard Setting, including setting science-based standards for PFAS in a variety of media.
- Sampling, including testing of public water systems and standardizing sampling methods.
- Pollution Prevention, including measures to address PFAS-containing firefighting foam and PFAS-containing waste.
- Engagement, Education, and Communication, including development of PFAS risk communication infrastructure and facilitation of environmental justice and health equity in communities.
- Research and Knowledge, including monitoring background levels of PFAS in the environment and collecting data on drinking water treatment and costs.
- Phase Out, including development of product stewardship mechanisms to reduce use of PFAS and minimizing the State's purchase of PFAS-containing products.
- Future Investments, including a collection and disposal program for PFAS-containing firefighting foam and providing support to veterans to address PFAS-related health risks.
- Identify and Address Historic Discharges, including development of tools to address PFAS-contaminated sites.
The plan also sets forth four guiding principles to inform Wisconsin's approach to addressing PFAS contamination: (1) environmental justice; (2) health equity; (3) innovation; and (4) pollution prevention. Although the plan includes general information about resources that may be necessary to carry out the recommendations, the plan indicated that specific financial and staffing recommendations were left to the executive and legislative branches to address.
*Margaret Barry also contributed to this newsletter.
© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
86 Fed. Reg. 469 (Jan. 6, 2021).
Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, White House (Jan. 20, 2021).
Stephen Lee & Dean Scott, Democrats to Target Trump Environment Rules, but Weigh Cost, Bloomberg Law (Jan. 13, 2021).
Asbestos Disease Awareness Org. v. EPA, No. 21-70160 (9th Cir., filed Jan. 26, 2021).A notice of intent to sue has also been sent to EPA asserting that the Agency failed "to perform its non-discretionary duty to address the use and disposal of 'legacy' asbestos in its risk evaluation." Notice of Intent to File Suit to Compel EPA to Perform Non-Discretionary Act under Section 6(b) of TSCA (Jan. 26, 2021).
Pub. L. No. 116-283, __ Stat. __ (H.R. 6395).
Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 86 Fed. Reg. 880 (Jan. 6, 2021); Phenol, Isopropylated Phosphate (3:1) (PIP 3:1); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 86 Fed. Reg. 894 (Jan. 6, 2021); 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 86 Fed. Reg. 866 (Jan. 6, 2021); Pentachlorothiophenol (PCTP); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 86 Fed. Reg. 911 (Jan. 6, 2021); Hexachlorobutadiene (HCBD); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 86 Fed. Reg. 922 (Jan. 6, 2021).
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 84 Fed. Reg. 36728 (July 29, 2019).
86 Fed. Reg. 1890 (Jan. 11, 2021); see also News Release, EPA, EPA Announces Plan to Reduce TSCA Fees Burden for Stakeholders (Mar. 25, 2020).
EPA, RIN 2070-ZA23, Compliance Guide for Imported Articles Containing Surface Coatings Subject to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances Significant New Use Rule (Jan. 19, 2021); 85 Fed. Reg. 45109 (July 27, 2020).
85 Fed. Reg. 75235 (Nov. 25, 2020).
86 Fed. Reg. 6322 (Jan. 21, 2021).
85 Fed. Reg. 68873 (Oct. 30, 2020).
86 Fed. Reg. 1495 (Jan. 8, 2021).
85 Fed. Reg. 74341 (Nov. 20, 2020).
86 Fed. Reg. 89 (Jan. 4, 2021).
85 Fed. Reg. 86558 (Dec. 30, 2020).
85 Fed. Reg. 82474 (Dec. 18, 2020).
85 Fed. Reg. 75010 (Nov. 24, 2020).
85 Fed. Reg. 70147 (Nov. 4, 2020).
86 Fed. Reg. 3932 (Jan. 15, 2021).
82 Fed. Reg. 7464 (Jan. 19, 2017).
85 Fed. Reg. 76077 (Nov. 27, 2020).
85 Fed. Reg. 76072 (Nov. 27, 2020).
The request and EPA's letter acknowledging the request are available at Supporting Documents for Manufacturer Requested Risk Evaluation for Octahydro-tetramethyl-naphthalenyl-ethanone Chemical Category (OTNE), EPA (last updated Dec. 8, 2020).
86 Fed. Reg. 6602 (Jan. 22, 2021).
Memorandum of Understanding Between the Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency and the Occupational Safety and Health Administration, U.S. Department of Labor for Implementation of TSCA Section 5 and Sharing of Confidential Business Information (Jan. 8, 2021); News Release, EPA, EPA and OSHA Sign Agreement Supporting Coordination on Chemical Reviews and Advancing Worker Safety (Jan. 12, 2021).
Gov't Accountability Office, GAO-21-156, Chemical Assessments: Annual EPA Survey Inconsistent with Leading Practices in Program Management (Dec. 2020).
News Release, EPA, EPA Delivers Results on PFAS Action Plan (Jan. 19, 2021).
The pre-publication version of the notice is available here.
The pre-publication version of the notice is available here.
The pre-publication version of the proposed rule is available here.
Links to the assessment and to a pre-publication version of the notice of its availability are available here.
86 Fed. Reg. 1960 (Jan. 11, 2021).
News Release, Cal. Dep't of Toxic Substances Control, California to Tire Makers: Please Remove Harmful Chemicals that Threaten our Aquatic Life and Waterways (Jan. 12, 2021).
2020 N.Y. Laws ch. 370 (S6829-B/A8829-A).
2020 N.Y. Laws ch. 307 (S8817/A4739-C).
2020 N.Y. Laws ch. 286 (S7880-B/A9952-B).
Del. Riverkeeper Network v. Pa. Dep't of Envtl. Prot., No. 285 M.D. 2019, 2021 WL 96887 (Jan. 12, 2021).
PFAS Chemical Action Plan, Dep't of Ecol. (last visited Jan. 27, 2021).
Wis. PFAS Action Council, Wisconsin PFAS Action Plan (Dec. 2020).