By Lynn L. Bergeson and Carla N. Hutton
On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant Directorates-General (DG) of the European Commission (EC), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability. According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for Sustainability objectives and monitor its implementation in dialogue with the stakeholders concerned.” Specific tasks include contributing to identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals. The expert group will act as a core group of ambassadors to facilitate discussions and promote this transition in the economy and society, developing a regular exchange of views, experiences, and good practices between the EC and stakeholders on the main objectives of the Strategy, namely:
- Innovating for safe and sustainable chemicals, including for materials and products;
- Addressing pressing environmental and health concerns;
- Simplifying and consolidating the legal framework;
- Providing a comprehensive knowledge base on chemicals; and
- Setting the example for global sound management of chemicals.
The expert group will consist of up to 32 members, with a maximum of:
- The Member State holding the Presidency of the Council of the European Union;
- Ten third-sector organizations in the following areas: health protection, environmental protection, human rights, animal protection, consumer rights, and workers’ rights;
- Eight scientific organizations, academia, and research institutes providing a suitable balance between expertise in fundamental research, applied research, and training/education;
- Ten industries, including small- and medium-sized enterprises (SME) or associations of enterprises, including an adequate representation of frontrunners in the production and use of safe and sustainable chemicals. Those should include chemical industries, downstream users (from different sectors), and retailers; and
- Three international organizations -- the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), and the United Nations Environment Program (UNEP).
Interested organizations are invited to submit their applications before March 18, 2021.
By Lynn L. Bergeson and Carla N. Hutton
On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA). EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks. As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals. The MOU formalizes coordination efforts that EPA and OSHA have already implemented and provides a framework for additional opportunities for collaboration. Highlights of the MOU include:
- Establishing designated staff and management points of contact from each agency to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
- Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
- Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.
More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.” The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA). Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5. According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.” EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”
According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances. Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A). Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5. The Compliance Advisory includes several questions and answers (Q&A), including:
Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?
No. Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical. Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements. If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties. PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50. TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.
EPA’s “compliance advisory” is disappointing. It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs. This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts. EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.
For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination. If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order. Neither option is commercially feasible or sustainable.
This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space. EPA’s “compliance advisory” is an unexpected and, to many, unwanted parting gift from the Trump Administration. The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2020, the 2020 Safer Choice Partner of the Year award winners. EPA recognized 18 Safer Choice Partner of the Year award winners across ten states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals that furthers outstanding or innovative source reduction. EPA states that the Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the 2020 Partner of the Year award winners represent businesses, including woman-owned and small- and medium-sized; federal and local government; and associations. The following organizations from eight EPA regions are being awarded this year:
- Apple -- Cupertino, California;
- BASF Home Care and I&I Cleaning Solutions -- Florham Park, New Jersey;
- Berkley Green -- Uniontown, Pennsylvania;
- The Clorox Company -- Oakland, California;
- Defunkify -- Eugene, Oregon;
- DuPont Nutrition & Biosciences -- Palo Alto, California;
- ECOS -- Cypress, California;
- Grove Collaborative -- San Francisco, California;
- Hazardous Waste Management Program -- King County, Washington;
- Household & Commercial Products Association -- Washington, D.C.;
- Jelmar, LLC -- Skokie, Illinois;
- Lemi Shine -- Austin, Texas;
- Naval Supply Systems Command Weapons System Support -- Mechanicsburg, Pennsylvania;
- PROSOCO -- Lawrence, Kansas;
- PurposeBuilt Brands -- Gurnee, Illinois;
- Sea Mar Community Health Centers -- Seattle, Washington;
- Seventh Generation -- Burlington, Vermont; and
- Wegmans Food Markets -- Rochester, New York.
More information is available on EPA’s website.
By Lynn L. Bergeson and Carla N. Hutton
On September 30, 2020, the U.S. Environmental Protection Agency (EPA) will hold a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List: A Proposed NAM Nomination Form.” The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended Section 4(h)(2)(c) of the Toxic Substances Control Act (TSCA) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.” The current TSCA Section 4(h)(2)(C) List is available on the EPA website. EPA’s 2018 Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program provides initial criteria for considering scientific reliability and relevance of new approach methodologies (NAM) to be eligible for placement on the List. EPA states that it “envisions that any party interested in proposing a NAM for placement on the List would use a nomination form.” The webinar will walk through the proposed nomination form.
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) International Science Consortium, EPA, and the Physicians for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 17, 2020, that it is accepting nominations for the 2021 Green Chemistry Challenge Awards. EPA intends these awards to recognize innovation by American businesses and researchers that redesign chemical products and processes to reduce or eliminate the use and manufacture of hazardous substances. The 2021 Green Chemistry Challenge Awards nomination package is now available, and nominations are due December 4, 2020. EPA states that it anticipates giving awards to “outstanding green chemistry technologies” in five categories in June 2021. EPA will host a webinar on September 23, 2020, for those interested in applying. During the webinar, EPA will provide an overview of the requirements, criteria, and tips for submitting a nomination package.
According to EPA, since the inception of the program, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,600 nominations and presented awards to more than 120 technologies. EPA notes that “by leveraging these technologies, the use or generation of hundreds of millions of pounds of hazardous chemicals have been avoided, and billions of gallons of water and trillions of BTUs in energy have been saved annually.” An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2021 submissions and make recommendations to EPA for the winners.
By Lynn L. Bergeson and Carla N. Hutton
On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and management controls in place to meet future statutory deadlines. The Lautenberg Act required EPA to develop new rules for chemical prioritization for risk evaluation and risk evaluation for existing chemicals and to review all new chemical submissions and make a regulatory determination. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG notes that because of statutory requirements, the number of required existing chemical risk evaluations doubled at the end of 2019, “risking the EPA’s ability to meet TSCA deadlines.”
OIG states that EPA’s ability to assess its TSCA workload -- and subsequently estimate the workforce levels necessary to achieve that workload -- “is critically important.” OIG notes that the Office of Pollution Prevention and Toxics (OPPT) has not publicly identified the additional staff and resources it needs to accomplish all mandated TSCA requirements. According to OIG, “OPPT’s resource planning is hindered by not complying with the U.S. Office of Personnel Management regulations, which requires developing a workforce plan to manage current and future workforce needs.”
OIG states that EPA’s program offices have not conducted a systematic workload analysis or identified workforce needs for budget justification purposes since 1987 and that this is also true for OPPT, which is responsible for implementing the TSCA amendments. According to OIG, though OPPT expects to hire more staff members to implement the TSCA amendments in fiscal year (FY) 2020, OPPT “lacks a workforce-and-workload analysis to successfully implement and meet the 2016 TSCA deadlines.” Additionally, OIG states, EPA’s annual plans for risk evaluations “were neither done in a timely manner nor met the statutory requirements to identify the resources needed to initiate or complete the risk evaluations for the year.”
OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention: (1) publish the annual existing chemical plan including the anticipated implementation efforts and required resources; (2) conduct a workforce analysis to assess OPPT’s capability to implement the TSCA amendments; and (3) specify what skill gaps must be filled in FY 2021 to meet the TSCA requirements. According to OIG, EPA “provided acceptable corrective actions and estimated milestone dates for all recommendations.” OIG “consider[s] these recommendations resolved with corrective actions pending.”
By Lynn L. Bergeson and Carla N. Hutton
As reported in our May 29, 2020, blog item, on May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination. OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of a 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order. OIG’s recommendations included that EPA implement a process for the Office of Enforcement and Compliance Assurance (OECA) to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities. On August 5, 2020, OIG announced that EPA has provided an update to its response to the OIG report. EPA states that the Office of Civil Enforcement/Waste and Chemical Enforcement Division (OECA/WCED) and the Office of Pollution Prevention and Toxics/Chemical Control Division (OCSPP/CCD) have developed a TSCA Section 5(e) Order Boilerplate that “clarifies and strengthens the provisions of the Order for New Chemical Substances.” According to EPA, in 2020, OCSPP/CCD and OECA/WCED established and implemented a Standard Operating Procedure (SOP) to ensure that WCED, the office responsible for compliance monitoring and enforcement activities, reviews and approves the terms and conditions of TSCA Section 5(e) Orders developed by CCD. EPA notes that the establishment of the SOP is intended to meet OIG’s recommendation. EPA states that the Review and Approval Protocol “provides sufficient assurance that compliance and enforcement requirements in TSCA 5(e) orders will be reviewed and approved by OCSPP and OECA.” OIG commented on EPA’s updated response, stating that it now considers this recommendation complete.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). Environmental Defense Fund v. Wheeler, No. 1:20-cv-762. On July 27, 2020, the parties submitted a joint case management statement. According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial. The parties state that they disagree about whether administrative records exist and the availability and scope of discovery, however. Resolving these questions will implicate the timing for any discovery, the appropriate deadline for final amended pleadings, and the appropriate schedule for summary judgment briefing. The parties note that they are currently discussing options to resolve as many of these questions as possible and that they believe successfully resolving them could reduce the number and complexity of procedural issues before the court. In particular, according to the statement, the parties are discussing options to narrow the scope of factual and legal issues presented, which may minimize the potential for future disputes over the availability and scope of discovery. The parties propose to submit an updated case management statement no later than August 31, 2020.
By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams
On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for the U.S. Environmental Protection Agency (EPA.) According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage are listed below:
- Review of Dust-Lead Post-Abatement Clearance Levels. On June 24, 2020, EPA published a proposed rule that would lower the amount of lead that can remain in dust on floors and windowsills after lead removal activities (dust-lead clearance levels (DLCL)) from 40 micrograms (µg) of lead in dust per square foot (ft2) to 10 µg/ft2 for floor dust and from 250 µg/ft2 to 100 µg/ft2 for window sill dust. 85 Fed. Reg. 37810. Comments on the proposed rule are due August 24, 2020. EPA intends to publish a final rule in September 2020.
- Reporting and Recordkeeping for Certain Chemicals under TSCA Section 8(a). EPA is developing a rulemaking under TSCA Section 8(a) to add certain chemicals that are on the TSCA Work Plan to the Chemical-Specific Reporting and Recordkeeping rules in 40 C.F.R. Part 704, Subpart B. EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals on the TSCA Work Plan, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization and risk evaluation of the chemical substances, as mandated under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in November 2020 and a final rule in June 2021.
- Revisions to the Fees Rule under TSCA. EPA is reviewing its 2018 final rule that established the requirements and procedures for setting and collecting fees from chemical manufacturers (including importers) and, in some cases, processors, submitters of new chemical substances, and others. TSCA Section 26(b)(4)(F) requires EPA to review and adjust the fees every three years and to consult with parties potentially subject to fees when the fees are reviewed and updated to reflect changes in program costs. EPA states that in addition to possible revisions resulting from this review, consistent with its announcement in March 2020, it will also consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that: (1) import the chemical substance in an article; (2) produce the chemical substance as a byproduct; and (3) produce or import the chemical substance as an impurity. EPA intends to issue an NPRM in December 2020 and a final rule in October 2021. More information on EPA’s March 2020 announcement is available in our April 17, 2020, blog item.
- Updates to New Chemicals Procedural Regulations to Reflect the 2016 TSCA Amendments: EPA states that the 2016 amendments impacted how it reviews and makes determinations on new chemical notices under TSCA Section 5. EPA acknowledges that as a result of these increased responsibilities, “it has become more challenging for EPA to complete reviews within 90 days.” This rulemaking seeks to revise the procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. EPA intends to increase the quality of information initially submitted in new chemicals notices and improve its processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review. EPA intends to publish an NPRM in September 2020 and a final rule in July 2021.
Rulemakings at the final stage include:
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices. On July 28, 2016, EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Section 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. EPA intends to issue a final rule in August 2020. More information on the proposed rule is available in our July 29, 2016, memorandum, “: TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.”
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances (PFAS); Significant New Use Rule (SNUR). In a January 21, 2015, proposed SNUR for LCPFAC and PFAS chemical substances, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of any article. 80 Fed. Reg. 2885. EPA proposed to make the exemption from notification requirements for persons who import the chemical substance as part of an article inapplicable for the import of a subset of LCPFAC chemical substances in all articles. As reported in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” EPA issued a supplemental proposal that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. EPA intended to issue a final rule in June 2020.
- Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h). TSCA Section 6(h) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances identified in the 2014 update of the TSCA Work Plan. EPA states that it is selecting among the available prohibitions and other restrictions in TSCA Section 6(a) to address risks of injury to health or the environment that the Administrator determines are presented by the chemical substances and reduce exposure to the chemical substances to the extent practicable. Since the statute states that a risk evaluation is not required for these chemical substances under TSCA Section 6(h), EPA developed an exposure and use assessment. According to the Unified Agenda item, EPA intends to take final action on all of the chemicals that were addressed in the July 29, 2019, proposed rule (i.e., the following PBT chemicals identified in TSCA Section 6(h): DecaBDE; phenol, isopropylated phosphate (PIP) (3:1); 2,4,6-tris(tert-butyl)phenol (TTBP); pentachlorothiophenol (PCTP); and hexachlorobutadiene (HCBD). Although addressed in a single proposed rule, EPA intends to issue separate final rules. EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of DecaBDE, and articles and products to which DecaBDE has been added with several exceptions, and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020. More information is available in our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA.”
- PIP (3:1); Regulation of PBT Chemicals under TSCA Section 6(h). EPA proposed to prohibit the processing and distribution in commerce of PIP (3:1), and products containing the chemical substance with several exceptions; prohibit releases to water from the non-prohibited processing, distribution in commerce, and commercial use activities. Persons manufacturing, processing, and distributing PIP (3:1), and products containing PIP (3:1), in commerce would be required to notify their customers of these restrictions, and EPA proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- TTBP; Regulation of PBT Chemicals under TSCA Section 6(h.). EPA proposed to prohibit the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a volume of less than 55 gallons for any use to prevent the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations (e.g., automotive repair shops, marinas). The proposed restriction also would prohibit 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, regardless of container size. EPA also proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- PCTP; Regulation of PBT Chemicals under TSCA Section 6(h). EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of PCTP, and products containing PCTP, unless in concentrations at or below one percent by weight; and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- HCBD; Regulation of PBT Chemicals under TSCA Section 6(h). For HCBD, EPA proposed no regulatory action. EPA intends to issue a final rule in December 2020.