By Lynn L. Bergeson and Carla N. Hutton
On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies. Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC. As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that concluded on June 17, 2020. After hearing closing arguments, Judge Chen asked plaintiffs and EPA to consider how to reach an agreement. According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.” Plaintiffs offered to submit a new petition to EPA that contains all of the evidence presented at trial, including the expert declarations, expert testimony, and exhibits. EPA contends that plaintiffs’ proposal to “package” the evidence presented at trial as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would be insufficient to reach a finding of unreasonable risk.” EPA maintains that “meaningful review of a new petition based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs” should include: (1) a systematic review; (2) raw data for the key studies upon which plaintiffs rely; and (3) the data underlying plaintiffs’ risk calculations, including their benchmark dose (BMD) analysis. Plaintiffs are willing to provide the data underlying Dr. Grandjean’s risk calculations, but “cannot agree to the other two requirements.” The joint statement states that first, plaintiffs maintain that they have already presented sufficient evidence to demonstrate an unreasonable risk under TSCA and are unwilling to do a new systematic review above and beyond what their experts have already done. Second, plaintiffs maintain that they do not have the ability to provide the “raw data” for the key studies upon which they rely because the data are not theirs, and that EPA is thus asking for something that plaintiffs cannot provide. Finally, plaintiffs do not believe that the raw data are necessary for EPA to evaluate the published peer-reviewed studies, and, indeed, requiring these data is “contrary to the health protective goals of TSCA.”
On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition. Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.” According to the plaintiffs, EPA articulated this policy shift in its March 18, 2020, supplemental notice of proposed rulemaking (SNPRM) regarding “Strengthening Transparency in Regulatory Science” in which “EPA proposed limiting, or excluding altogether, its reliance on any peer reviewed study -- no matter how relevant or well regarded -- if the underlying raw data [are] not made publicly available.” Plaintiffs cite a “detailed analysis signed by dozens of Harvard scientists,” which states that “EPA’s new policy ‘is based on a profoundly misguided view of how the scientific process works’ and ‘unnecessarily impedes EPA’s ability to base its internal analyses and regulatory decisions on the best available science.’ Further, the rule ‘adopts a partial and biased approach to transparency that systematically favors industry science over academic science.’”
EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.” According to EPA, by releasing the raw data and a detailed explanation of their statistical methods, the authors of the studies “could satisfy incongruities and ensure the scientific record is clear.” EPA states that it “takes the position that a meaningful substantive review, as contemplated by the Court, of the evolving scientific evidence published since Plaintiffs submitted their 2016 petition should include raw data for the key studies upon which Plaintiffs rely and, according to Dr. Grandjean’s trial testimony, is forthcoming.” EPA reiterates that its position “is based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs as necessary to support a potential TSCA section 6(a) rulemaking” and not, as alleged by plaintiffs, “a broader policy shift.”
The court held a status conference on August 6, 2020, via Zoom. The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so. The next status hearing will be held November 5, 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.
By Lynn L. Bergeson and Carla N. Hutton
On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride. The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.” The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council. According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chloride from their air and water.”
As reported in our June 25, 2020, memorandum, “Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments,” after evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk. EPA also determined that methylene chloride does not present an unreasonable risk to the environment under any conditions of use. Release of a final risk evaluation is the last step in the Toxic Substances Control Act (TSCA) Section 6(b) process and will guide EPA’s efforts in applying Section 6(a) to reduce human exposure to methylene chloride “so that the chemical . . . no longer presents such risk.” EPA “will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.” EPA could prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of methylene chloride. Any regulatory action will include opportunities for public comment.
By Lynn L. Bergeson and Carla N. Hutton
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA). According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective public communication in developing risk mitigation requirements for companies following EPA completion of a Risk Evaluation under TSCA.” ACA states that a procedural rule “is needed to establish a central point of reference for all requirements and considerations involved in crafting a risk management rule regulating a specific chemical.” The petitioners ask EPA to implement an updated risk management procedural rule addressing considerations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). According to the press release, the petition lists and describes various risk mitigation considerations under the Lautenberg Act’s framework that should be addressed in a procedural rule, including considerations related to transparency, deadlines for compliance, notice, effective dates, exemptions for critical or essential use, coordination with and/or delegation to other agencies, and processes to amend a risk mitigation rule. ACA states that EPA has 90 days from filing to grant or deny the petition. If EPA grants the petition, EPA can enter into a public rulemaking process, as requested by petitioners, though it is not required to do so. ACA notes that while the Administrative Procedure Act (APA) provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements, “petitioners believe that EPA should publish the requested section 6 risk management procedural rule for notice and comment because the information and opinions supplied by the public will inform the Agency’s views.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged. Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required to self-identify as a manufacturer of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA. EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA). During the 60-day comment period, the public will have the opportunity to correct errors or provide comments on the preliminary lists. According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances. Manufacturers (including importers) identified on the final lists will be subject to applicable fees.
Once the Federal Register notice is published, the preliminary lists will be available in docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA’s website at http://www.epa.gov/TSCA-fees. EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).” According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.” Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate. To include the two most recent CDR reporting cycle data (collected every four years) and to account for annual or other typical fluctuations in manufacturing (including import), EPA states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).
More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.” More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”
See Also: "Are You Potentially Responsible for TSCA Fees? EPA Issues Preliminary Lists of Companies Responsible for TSCA Risk Evaluation Fees" episode of All Things Chemical™ podcast
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on December 2, 2019, that it granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production. EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA). Manufacturer-requested risk evaluations are conducted in the same manner as other risk evaluations conducted under TSCA Section 6(b)(4)(A). EPA received the manufacturer requests from ExxonMobil Chemical Company (for DIDP) and from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex (for DINP), both through the American Chemistry Council’s High Phthalates Panel. Both chemicals were identified in the 2014 Update to the TSCA Work Plan. As reported in our August 17, 2019, blog item, EPA held a public comment period on the requests, as well as additional conditions of use that EPA identified to include in the risk evaluations. More information is available in our August 19, 2019, memorandum, “EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019. Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for consumer use, including e-commerce sales. EPA states that it “is encouraging all consumers to stop using methylene chloride products that they may have already purchased for paint and coating removal.” EPA also reminds all retailers that sales of these products to consumers are prohibited by EPA regulations under the authority of Section 6 of the Toxic Substances Control Act (TSCA). EPA promulgated the final regulation on methylene chloride for consumer paint and coating removal use on March 27, 2019, and the prohibition related to manufacturing, processing and distribution of methylene chloride for consumer paint and coating removal use is now in effect. According to EPA, “[a] variety of effective, less harmful substitutes are readily available for paint removal.” EPA notes that it “is continuing to work through the process outlined in TSCA to review the risks associated with other uses of methylene chloride. This process is designed to thoroughly evaluate available science before taking action to manage the risk associated with the other uses of the chemical.”
More information on EPA’s actions concerning methylene chloride are available in the following memoranda:
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 12, 2019, announcing the availability of its response to a petition it received under Section 21 of the Toxic Substances Control Act (TSCA) from Public Employees for Environmental Responsibility (PEER). 84 Fed. Reg. 60986. As reported in our August 23, 2019, blog item, PEER petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries under TSCA Section 6(a) and under the Administrative Procedure Act (APA) to take the same action pursuant to Section 112 of the Clean Air Act (CAA). PEER petitioned EPA to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries and require a phase-out of use at such facilities within two years. EPA states that after “careful consideration,” it has denied the Section 21 petition. EPA notes that the Federal Register notice specifically addresses only the TSCA Section 21 petition, not the petition submitted under the APA. EPA is denying the petition “based on the petition’s lack of sufficient facts establishing that it is necessary for the Agency to issue a rule under TSCA section 6(a).” According to EPA, to grant a petition for a TSCA Section 6(a) rulemaking, a petition must provide facts establishing that the requested rulemaking is necessary. Those facts need to be “sufficiently clear and robust for EPA to be able to conclude, within 90 days of filing the petition, that the chemical presents an unreasonable risk of injury to health or the environment and that issuance of a TSCA section 6(a) rule is the appropriate response to the petition.” To make the threshold finding, EPA needs hazard and exposure data and other information to enable it to assess risk and conclude whether the risk is unreasonable. In this case, EPA states that PEER’s petition “refers to hazard databases and makes conclusory statements of toxicity but provides little further information that would support granting a TSCA section 6(a) rulemaking request.” According to EPA, the petition lacks the analysis that would be expected in a TSCA risk evaluation preceding a Section 6(a) rulemaking, such as “discussion of the appropriate hazard threshold, exposure estimates, assessment of risks, or how the facts presented allow EPA to comply with its duties under section 26 or other statutory requirements in making an unreasonable risk determination.” Absent such information, EPA “cannot make the threshold determinations necessary to substantively assess and grant a petition for a TSCA section 6(a) rulemaking.” EPA denies PEER’s petition request as facially incomplete.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 36728. EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action. For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1). Comments are now due October 28, 2019. EPA is required to issue a final rule by December 2020. Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.
By Lynn L. Bergeson and Carla N. Hutton
On September 4, 2019, the U.S. Environmental Protection Agency (EPA) released new guidance intended to help methylene chloride processors and distributors comply with EPA’s March 2019 rule issued under Section 6(a) of the Toxic Substances Control Act (TSCA) prohibiting the manufacture (including import), processing, or distribution in commerce of methylene chloride for consumer paint and coating removal. The final rule became effective on May 28, 2019. Each person who manufactures, processes, or distributes in commerce methylene chloride for any use after August 26, 2019, must comply with the requirements for downstream notification and recordkeeping. The guidance describes the requirements EPA established to address unreasonable risks from the use of methylene chloride in consumer paint and coating removal. The guidance also:
- Defines key terms;
- Identifies the regulated entities;
- Describes the required or prohibited activities; and
- Summarizes the downstream notification and recordkeeping requirements.
EPA notes that the small entities directly regulated by the rule include:
- Processors (since they formulate paint and coating removers containing methylene chloride);
- Distributors of methylene chloride;
- Distributors of paint and coating removers containing methylene chloride; and
EPA states that the rule is fully effective on November 22, 2019, when prohibitions on manufacturing (including importing), processing, or distributing methylene chloride for consumer paint and coating removal go into effect. This ban includes a prohibition on distributing any methylene chloride for paint and coating removal to or by retailers, including e-commerce retailers. More information on EPA’s final rule is available in our March 20, 2019, memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”