The Chemical Compound—October 2020
This quarterly newsletter provides updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our present focus is on 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
- Case Challenging EPA Denial of Fluoridation Rulemaking Petition Held in Abeyance and Plaintiffs Directed to File New Petition
- Summary Judgment Motions Attack and Defend EPA Denial of Petition to Require Asbestos Reporting
- Second Circuit Vacated Reporting Exemption for Importers of Mercury-Containing Products but Upheld Two Other Mercury Reporting Exemptions
- Senators Identified Priority PFAS Provisions for Inclusion in Defense Bill
- House Appropriations Bill Would Bar EPA Withdrawal from Certain Regulation of PFOA and PFOS
- November 1 Deadline for CBI Substantiation for Active Substances on TSCA Inventory
- November 30 Deadline for Chemical Data Reporting Submissions
- EPA Issued Final Rule Intended to Improve Guidance Practices
- Environmental Groups Submitted TSCA Petition Asking EPA to Require PFAS Testing
- EPA Released Final Scopes for Next 20 Risk Evaluations and Lists of Companies with Fee Obligations; Proposal for Fees Rule Amendments Goes to OMB
- EPA in Process of Finalizing PBT Risk Management Rules
- EPA Published Three Final Risk Evaluations; Two (So Far) Face Judicial Challenges
- Peer Review Reports Found Asbestos Risk Evaluation to Be Inadequate, Recommended Improvements to PCE and TCE Evaluations
- EPA Granted Manufacturer Request for Risk Evaluation of Siloxane
- EPA Staffing News: Critical Report from Inspector General in August, Reorganization Plan in September
- Trade Groups Seeking Rule to Provide "Procedural Guardrails" for TSCA Risk Management Process
- EPA Posted Plans to Issue Rules on Section 8(a) Reporting for Work Plan Chemicals and New Chemical Review Procedures
- FDA and Manufacturers Announced Agreement to Phase Out Some Short-Chain PFAS from Food Packaging
- EPA Finalized Significant New Use Rule for LCPFAC Substances that Encompasses Import of Certain Articles; Guidance Coming in December
- New Hampshire
- New Jersey
- New York
Case Challenging EPA Denial of Fluoridation Rulemaking Petition Held in Abeyance and Plaintiffs Directed to File New Petition
In August, a federal district court issued an order holding in abeyance the lawsuit challenging EPA's denial of a TSCA Section 21 petition requesting that EPA regulate fluoridation of drinking water pursuant to Section 6(a) of TSCA.1 The court also directed the plaintiffs to submit a new petition to EPA. The court identified two reasons for the order. First, the court indicated the plaintiffs needed to address "serious standing issues" because at trial they failed to demonstrate a link between their evidence—which "focused overwhelmingly, if not exclusively" on whether fluoride presented a risk of neurodevelopmental harm—and the harms alleged by the named plaintiffs, which included headaches, increased pain sensitivity, and an increased risk of Alzheimer's disease or dementia. The court said none of the standing plaintiffs claimed to be subject to the risk of neurodevelopmental harm. Second, the court said a second petition would give EPA an opportunity to consider new scientific developments. The court noted that the evidence in the original petition was "very different" from the evidence the plaintiffs presented at trial and, moreover, that EPA acknowledged that the new studies presented were "the highest quality, most reliable studies to date." The court also mentioned the imminent release of the National Toxicology Program's (NTP's) systematic review as a development that could "add substantially to the body of scientific analysis relevant to the precise questions before this court." The court urged EPA to give a new petition "due consideration on the merits in light of the substantial scientific evidence proffered at trial" and "not to deny the petition simply because a complete set of raw data from the studies cited in the petition is not provided or available." On September 16, 2020, the NTP released for peer review a draft monograph on its systematic review of fluoride exposure and neurodevelopmental and cognitive health effects. In the draft document—which the NTP emphasized was "distributed solely for the purpose of pre-dissemination peer review and does not represent and should not be construed to represent any NTP determination or policy"—the NTP found that for exposure to fluoride in amounts typically found in drinking water (0.7 mg/L), effects on cognitive neurodevelopment "are inconsistent, and, therefore, unclear," but that for higher fluoride levels (above 1.5 mg/L), "fluoride is presumed to be a cognitive neurodevelopmental hazard to humans."2 A committee of the National Academies of Sciences, Engineering, and Medicine is now reviewing the monograph.
Summary Judgment Motions Attack and Defend EPA Denial of Petition to Require Asbestos Reporting
Plaintiffs and EPA have filed summary judgment motions in two cases challenging EPA's denial of rulemaking petitions requesting that the Chemical Data Reporting (CDR) Rule be amended to require reporting on asbestos.3 Ten states and the District of Columbia argued in their July 14, 2020 motion that "[w]ithout robust reporting" EPA could not "effectively evaluate the actual risks posed by asbestos in the environment." The states—which said EPA admitted during the ongoing TSCA Section 6 risk evaluation process for asbestos that it lacked information about the volume of asbestos and asbestos-containing products in commerce—contended that EPA's denial of requests to require reporting on the amounts of asbestos in commerce was arbitrary and capricious, an abuse of its discretion in administering TSCA, and contrary to TSCA's mandates. Similarly, public health organizations contended that EPA's refusal to require reporting on asbestos—which the organizations noted was the only one of the first 10 chemicals undergoing risk evaluations not to be subject to the CDR Rule—was arbitrary and capricious and contrary to TSCA. They also argued that EPA had sufficient time to amend the CDR Rule in advance of the completion of the asbestos risk evaluation and that, in any event, additional information about asbestos would be needed for a future risk management rule. In defense of the denial of the petition, EPA argued in its September 1, 2020 response and cross-motion that the plaintiffs did not have standing, that the Agency had broad discretion to decide whether to require reporting under TSCA, and that the Agency reasonably denied the petitions, including because EPA reasonably determined that the requested reporting would not result in reporting of new information.
Second Circuit Vacated Reporting Exemption for Importers of Mercury-Containing Products but Upheld Two Other Mercury Reporting Exemptions
The Second Circuit Court of Appeals vacated an exemption for importers of assembled products containing mercury-added components in the 2018 Mercury Reporting Rule.4 Information collected under the Rule is intended to help EPA prepare triennial inventories of mercury supply, use, and trade in the United States. The Second Circuit upheld two other exemptions—one for manufacturers of products with mercury-added components and the other for manufacturers or importers of elemental mercury or mercury compounds in higher volumes. The Second Circuit found that the exemption for manufacturers of products containing mercury-added components was a "reasonable interpretation" of TSCA since the product manufacturer would only be exempt if another manufacturer or an importer previously introduced the mercury-added component into the US market. The court therefore found that it was reasonable for EPA to deem it "unnecessary or duplicative" for both manufacturers to report. The Second Circuit concluded, however, that reporting by importers of products with mercury-added components would not be duplicative since no other entity would be required to report the mercury in the component. The court further found that EPA's rationales for the importer exemption did not amount to a reasoned explanation. The Second Circuit upheld the partial exemption for high-volume manufacturers and importers from reporting certain information, finding that the exemption was a reasonable interpretation of EPA's obligation not to require duplicative reporting since there was "substantial overlap" with the CDR Rule's reporting requirements.
Senators Identified Priority PFAS Provisions for Inclusion in Defense Bill
On October 7, 2020, Senator Jeanne Shaheen and 20 other senators sent a letter to the chairs and ranking members of the committees negotiating the Fiscal Year 2021 National Defense Authorization Act, encouraging negotiators to include five sections addressing per- and polyfluoroalkyl substances (PFAS) in the final bill:
- A provision in the Senate bill (S. 4049) to increase from $10 million to $15 million the amount authorized for an ongoing PFAS health impacts study by the Agency for Toxic Substances and Disease Registry.
- A provision in the House bill (H.R. 6395) to require PFAS blood testing for service members stationed at one of the 651 military installations impacted by PFAS, with the provision expanded to cover military families and veterans.
- A provision in the House bill authorizing a study of the presence of PFAS in firefighting personal protective equipment and establishing a grant program "to advance the development of safe alternatives to PFAS chemicals in personal protective equipment."
- A provision in the Senate bill to modify the National Guard's authority for environmental restoration projects and to make technical corrections to the statute for the Defense Environmental Restoration Program to ensure restoration of contamination by perfluorooctane sulfonic acid and perfluorooctanoic acid.
- A section of the Senate bill requiring the Secretary of Defense to look into firefighting technologies and substances to facilitate phase-out of PFAS-containing firefighting foams and requiring the Secretary to brief congressional defense committees on the results of the research within 180 days.
In September, the ranking member of the House Committee on Armed Services said the final conference report would not be available before the election but that it was likely to come out "pretty quickly" after the election.5
House Appropriations Bill Would Bar EPA Withdrawal from Certain Regulation of PFOA and PFOS
An appropriations bill (H.R. 7608) passed by the House of Representatives on July 24, 2020 included an amendment that would bar EPA from using funds to withdraw its preliminary regulatory determination to regulate perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) under the Safe Drinking Water Act or a proposed rule designating PFOA and PFOS as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). (EPA has not yet proposed the CERCLA designation but indicated in its Spring 2020 regulatory agenda that it intended to do so, with a target date of August 2020 for the proposed rule.)
By November 1, 2020, businesses that filed a Notice of Activity Form A to report a chemical substance as an "active" substance on the TSCA Inventory must substantiate any claim that the specific chemical identity of the substance constitutes confidential business information (CBI).6 November 1 is also the deadline for amending any such CBI claim. To substantiate a claim, a business must submit written answers to questions specified in 40 C.F.R. 710.45(b). Answers must be signed and dated by an authorized official, and a certification statement must be completed. The substantiation must be submitted electronically via EPA's Central Data Exchange. Failure to submit by the deadline will result in EPA's denial of the claim.7 Records documenting any submission must be kept for five years. EPA's target completion date for reviews of CBI claims for the specific chemical activities of active substances is February 19, 2024. At the beginning of each year, EPA will post an annual goal for reviews and the number of reviews completed in the prior year.
November 30 Deadline for Chemical Data Reporting Submissions
The deadline for the current four-year cycle of reporting under the Chemical Data Reporting (CDR) Rule is November 30, 2020. Manufacturers and importers must report if their production volume for a non-excluded chemical substance on the TSCA Inventory at a single site was at least 25,000 pounds for any reporting year between 2016 and 2019. A 2,500-pound threshold applies to substances that have been subject to certain regulatory or judicial actions under TSCA. Submissions must be made electronically, using e-CDRweb. The CDR Rule—which was updated earlier this year—is codified at 40 C.F.R. Part 711; EPA's website contains additional information about reporting requirements. Earlier this year, EPA released updated data collected in the 2016 CDR submission period, which included information that would have been classified as confidential business information prior to the 2016 amendments to TSCA, including aggregate production volumes and site-specific production volumes.8
EPA Issued Final Rule Intended to Improve Guidance Practices
Beginning on November 18, 2020, an EPA rule establishing procedures and requirements for issuance and maintenance of guidance will take effect.9 The regulation—which EPA adopted to implement President Trump's 2019 executive order on "Promoting the Rule of Law Through Improved Agency Guidance Documents"10—institutes the following internal practices and procedures. First, EPA codified the requirement for an online portal listing all effective, active guidance.11 The portal is available here. EPA "fully populated" the portal on July 31, and beginning on the effective date, any guidance document excluded from the portal "does not represent an active guidance document of the Agency and will have no effect except to establish historical facts." The regulation defines "guidance document" as "an Agency statement of general applicability, intended to have future effect on the behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation." This definition is subject to enumerated exclusions, including for "[i]nternal guidance directed to the EPA or its components or other agencies that is not intended to have substantial future effect on the behavior of regulated parties" and "[a]gency statements of specific, rather than general, applicability."12 EPA also established certain minimum requirements for guidance documents (e.g., including a date of issuance and a short summary)13 and imposed a requirement for public notice and a 30-day comment period for "significant guidance documents,"14 which is a term defined in the 2019 executive order. In addition, the rule provides that the public can petition EPA to modify or rescind active guidance or to reinstate rescinded guidance.15 The new rule will be codified at 40 C.F.R. §§ 2.501–2.507.
Environmental Groups Submitted TSCA Petition Asking EPA to Require PFAS Testing
On October 13, 2020, six environmental groups submitted a rulemaking petition to EPA pursuant to TSCA Section 21 requesting that the Agency require health and environmental effects testing of 54 PFAS they allege were manufactured at a chemical production facility in Fayetteville, North Carolina. The petitioners sought issuance of a rule or order pursuant to TSCA Section 4 directing the manufacturer "to fund and carry out this testing under the direction of a panel of independent scientists."16 The petitioners said the 54 PFAS were attributable to the facility and had been detected in the environment or in people in the Cape Fear River watershed adjacent to and downstream from the facility. They contended that the 54 PFAS met Section 4(a)(1)(A)'s criteria for EPA action because, the petitioners asserted, the PFAS "may present an unreasonable risk of injury," there is "insufficient information and expertise" to determine their effects, and testing is "necessary" to develop such information. The petitioners proposed a testing program that included experimental animal studies; human studies; and ecological effects/fate and transport and physical-chemical properties studies. The petitioners' proposal for the independent science panel would have EPA contract with the National Academy of Sciences and would allow the public and the manufacturer to submit nominations. EPA acknowledged receipt of petition, with a receipt date of October 14, and posted the petition on its website listing Section 21 petitions. 17 EPA has 90 days to act on Section 21 petitions.
EPA Released Final Scopes for Next 20 Risk Evaluations and Lists of Companies with Fee Obligations; Proposal for Fees Rule Amendments Goes to OMB
On September 4, 2020, EPA published notice of the availability of the final scope documents for risk evaluations of the 20 substances that EPA designated as High-Priority Substances under TSCA Section 6 in December 2019.18 The scope documents include the conditions of use, hazards, exposures, and potentially exposed or susceptible subpopulations EPA plans to consider in conducting the risk evaluations. The purpose of the risk evaluations is to determine whether each substance presents "an unreasonable risk of injury to health or the environment."19 EPA published a separate document responding to comments the Agency received on the draft scope documents, including comments regarding the overall risk evaluation process and about specific elements of the scope documents.20 Risk evaluations for the 20 High-Priority Substances must be completed by December 2022, with the possibility of a six-month extension.
On September 4, EPA also published notice of the availability of the final lists of manufacturers and importers subject to fee obligations for these risk evaluations, as well as a list of companies that certified to ceasing manufacture or import of the High-Priority Substances.21 Companies subject to the fee obligation for a High-Priority Substance must contribute to a total fee of $1,350,000, with small businesses subject to lower fee obligations. Companies may form a consortium to pay the fee but most notify EPA within 60 days (by November 3) that a consortium has been formed. EPA released interim final lists of companies subject to the fees approximately a week before publishing the final lists to give companies time to review the lists for accuracy and to reach out to other companies regarding the formation of consortia. In the September 4 notice, EPA indicated it was considering "options for payment flexibilities" in light of the economic conditions caused by the COVID-19 pandemic.
In another development related to TSCA fees, EPA sent its proposal for amending the TSCA Fees Rule to the Office of Management and Budget (OMB) on October 14. This proposal is likely to include exemptions to fee obligations for importers of chemical substances in articles and manufacturers of byproducts and impurities. EPA earlier this year announced that it intended to exempt these categories of manufacturers from obligations to self-identify as manufacturers of the first 20 High-Priority Substances.22 There have been indications that EPA may have considered other exemptions, including for research and development, non-isolated intermediates, and de minimis amounts.23
EPA in Process of Finalizing PBT Risk Management Rules
EPA is required by TSCA Section 6(h) to promulgate final risk management rules for five persistent, bioaccumulative, and toxic (PBT) chemicals by January 2021. The substances are: decabromodiphenyl ether (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). EPA proposed restrictions on four of the substances in July 2019 but proposed not to take action on HCBD under Section 6 because other environmental laws already regulate the substance.24 Since July 23, 2020, EPA has sent drafts of its final rules for all five of the substances to the White House Office of Management and Budget for interagency review. The Agency has indicated that it plans to finalize these rules by the end of the year. In June and July, EPA received two requests for critical use exemptions under Section 6(g) for use of PIP (3:1) in certain coatings and paints and for time-limited import, processing, and distribution of certain PIP (3:1)-containing film articles.25
EPA Published Three Final Risk Evaluations; Two (So Far) Face Judicial Challenges
Methylene Chloride. In June 2020, EPA issued the final risk evaluation for methylene chloride, finding that the substance presents unreasonable risks to human health for 47 of the 53 conditions of use, including all consumer uses and most commercial uses (for which EPA found unreasonable risks both for workers and occupational non-users).26 EPA found no unreasonable risk to the environment. EPA has one year to propose a risk management rule and must finalize risk management regulations for methylene chloride within two years. Environmental groups and a union have filed suit in the Ninth Circuit challenging the risk evaluation's determinations that methylene chloride does not present an unreasonable risk under certain conditions of use and its failure to consider certain uses and pathways of exposure,27 while 11 states, New York City, and the District of Columbia filed a petition for review in the Second Circuit.28 EPA has asked the Second Circuit to transfer venue to the Ninth Circuit. In September, the Ninth Circuit granted motions to intervene by three trade groups: Halogenated Solvents Industry Alliance, Inc., American Chemistry Council, and N-Methylpyrrolidone Producers Group, Inc. The petitioners' opening brief in the Ninth Circuit is due December 7, 2020.
1-Bromopropane. In August, EPA released a final risk evaluation for 1-bromopropane (1-BP).29 EPA found unreasonable risk to human health for consumers and bystanders from all consumer uses except for insulation off-gassing. Consumer uses include aerosol spray degreasers/cleaners, spot/stain removers, adhesives used in arts and crafts, and automobile care products such as air conditioning system cleaners. EPA also found unreasonable risk to workers and occupational non-users from most commercial uses, including solvents for vapor degreasing and cleaning, adhesives, dry cleaning solvents, cleaners for metal and electronic components, and automotive care products. EPA found no unreasonable risk to the environment or to the general population from 1-BP. EPA noted that ambient air and hazardous waste exposure pathways were under the jurisdiction of other EPA-administered statutes and therefore were not part of the risk evaluation.
HBCD. In the Cyclic Aliphatic Bromide Cluster (HBCD) evaluation, which was completed in September,30 EPA found no unreasonable risk to the general population or consumers and found unreasonable risks to the environment from six conditions of use (import, processing, recycling, commercial use, consumer use, and disposal) based on impacts to aquatic, sediment-dwelling, and terrestrial species. In addition, EPA found that HBCD presents an unreasonable risk to workers and occupational non-users from use and disposal of HBCD in building and construction materials such as insulation. EPA's conclusions changed from its determination in the draft risk evaluation, which found that HBCD did not present an unreasonable risk. On October 16, Alaska Community Action Toxics filed a petition for review in the Ninth Circuit Court of Appeals challenging EPA's "no unreasonable risk" determinations and decisions to exclude certain uses and pathways from the risk evaluation.31
Peer Review Reports Found Asbestos Risk Evaluation to Be Inadequate, Recommended Improvements to PCE and TCE Evaluations
On August 27, 2020, the TSCA Science Advisory Committee on Chemicals (SACC) issued its peer review report on the draft risk evaluation for asbestos.32 The report stated that, overall, the draft evaluation "was not considered adequate and resulted in low confidence in the conclusions." The report identified the draft evaluation's limited focus on exposure to chrysotile asbestos fibers in six conditions of use as reason for this conclusion, as well as missing data for environmental exposures. Regarding the scope of the risk evaluation, the SACC report indicated that the absence of exposure sources such as drinking water, talc, asbestos-containing building materials, and vermiculite made the estimate for total exposure to asbestos deficient. The report noted EPA's plan to address "legacy" uses of asbestos in the future and indicated that the SACC "expressed mixed views" regarding whether EPA should finalize this draft risk evaluation or "fold it into a more comprehensive future review." The SACC recommended that if EPA finalized this evaluation, the title should reflect its limited scope and the evaluation should explain how legacy uses will be addressed and how the more limited evaluation fits into the overall asbestos evaluation process.
Earlier in August, the SACC issued its peer review report on the draft risk evaluation for perchloroethylene (PCE), which included 191 recommendations for improvements.33 Among other things, the report commented that the SACC regarded the regulation of PCE under non-TSCA statutes as "insufficient justification for excluding multiple routes of exposure from consideration in this risk evaluation." The report also noted the SACC's discussion of the need to incorporate PCE exposures through legacy uses into the risk evaluation.
In June, the SACC issued its final report on the draft risk evaluation for trichloroethylene (TCE), which included 135 recommendations for improvements.34 The report noted that some SACC members expressed that issues identified with a study that showed cardiac effects at TCE exposure levels "orders of magnitude lower than no-effects levels of other studies" made it "difficult for them to support this study's use in establishing a point of departure." The report also indicated that the SACC did not agree with the decision not to characterize chronic risk for consumer exposures and encouraged EPA to provide additional information about occupational exposure pathways that were excluded. In addition, the report said the risk evaluation's discussion of personal protective equipment (PPE) was too limited and that the evaluation should identify conditions of use for which there are low expectations of appropriate PPE use.
EPA Granted Manufacturer Request for Risk Evaluation of Siloxane
On October 6, 2020, EPA notified the American Chemistry Council's Silicones Environmental, Health, and Safety Center (SEHSC) that the Agency was granting a manufacturer request submitted by SEHSC on behalf of six companies for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4).35 In its announcement of the decision to grant the request, EPA described D4 as "a chemical used to make other silicone chemicals and as an ingredient in some personal care products."36 EPA indicated in the notification letter that the Agency had found that each circumstance identified in the manufacturer request constituted a condition of use that should be included in the risk evaluation. The manufacturer request summarized the conditions of use as "manufacture of D4, processing of D4 as a reactant or by incorporation into a formulation, mixture, or reaction product, and commercial/consumer uses of products that include D4 in their manufacture (e.g., adhesives and sealants, automotive care products, cleaning and furnishing care products, paints and coatings, plastic and rubber products, polishes and sanitation goods, and soaps and detergents) and disposal."37 (The draft risk evaluation the manufacturers included with their request described the conditions of use in more detail.) EPA—which must now prepare a scope for its risk evaluation by April 6, 2021—posted a list of additional conditions of use that may warrant inclusion in the scope, including some conditions of use—e.g., personal care products, laboratory chemicals—that the manufacturers' draft risk evaluation indicated were not relevant for risk evaluation.38 EPA said the additional uses may warrant inclusion in the scope and also indicated that the list did not constitute all uses that may be evaluated.
EPA Staffing News: Critical Report from Inspector General in August, Reorganization Plan in September
On August 17, 2020, EPA's Office of Inspector General (OIG) issued an audit report on EPA's staff and resource planning and its impact on implementation of the amended TSCA.39 The report found that EPA had not completed its risk evaluations of the initial 10 existing chemical substances by the June 2020 deadline and that its ability to meet future TSCA deadlines was at risk. In addition, the report found that EPA's noncompliance with Office of Personnel Management workforce planning and analysis requirements hindered its resource planning. In response to the OIG report, EPA agreed to add additional information about both the status of risk evaluations and also the allotment of staff and other resources to its annual plan on existing chemical risk evaluations. EPA also agreed to conduct a workforce analysis focused on the ability of Office of Pollution Prevention and Toxics to implement TSCA requirements and also to specify "skill gaps" that must be filled.
In September 2020, EPA officials advised staff of the Office of Chemical Safety and Pollution Prevention (OCSPP) that the office was being reorganized.40 The moves affect staff who work on pesticide registration and TSCA implementation. Announced changes included the establishment of separate branch divisions for risk evaluation and for risk management, and a new division for risk assessment and management of new chemical substances. In a September 8 letter from EPA Assistant Administrator Alex Dunn to members of Congress about the reorganization, Dunn advised that the reorganization "will not result in a reduction-in-force or require involuntary relocations" or "eliminate any of the current functions" of OCSPP. The reorganization, according to the Dunn letter, is intended to enable the office to better handle the demands of the 2016 TSCA amendments and the pesticide office's functions addressing demands for new antimicrobial products in the face of the current health crisis. The reorganization also moves and integrates a number of cross-office functions (including coordination of science policy issues) into a new Office of Program Support.
Trade Groups Seeking Rule to Provide "Procedural Guardrails" for TSCA Risk Management Process
In June 2020, five trade associations submitted a petition to EPA requesting issuance of a risk management procedural rule under Section 6.41 The petition contended that EPA's risk management process needed "procedural guardrails … to guide EPA and affected stakeholders so that risk management is consistently applied and appropriately tailored." The petition therefore sought a "framework rule" similar to those promulgated for the risk prioritization and risk evaluation processes. On July 28, EPA responded with a letter acknowledging receipt of the petition.42 Although the trade associations said they submitted the petition pursuant to TSCA Section 21, EPA determined that the petition was not a valid "Section 21" petition under TSCA. The July 28 letter indicated that the Agency would consider it a petition under the Administrative Procedure Act.
EPA Posted Plans to Issue Rules on Section 8(a) Reporting for Work Plan Chemicals and New Chemical Review Procedures
In the Spring 2020 unified regulatory agenda released in early July 2020, EPA included an item for a proposed rule under TSCA Section 8(a) that would require reporting on chemical substances included in the 2014 update of the TSCA Work Plan for Chemical Assessments. EPA said it was developing the rule "to obtain information about potential hazards and exposure pathways … , particularly occupational, environmental, and consumer exposure information." EPA indicated it would use the information gathered under such a rule to support its risk prioritization and evaluation activities under TSCA Section 6. The agenda identified November 2020 as the target date for issuance of the proposed rule. The regulatory agenda also indicated that EPA planned to propose amendments to its procedural regulations for new chemical review to reflect changes made in the 2016 amendments. The agenda stated that "[t]his rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve the Agency's processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review." The proposed rule was slated for issuance in September 2020; Inside EPA reported on October 22 that EPA said the rule would be proposed "no later than beginning of 2021."43
FDA and Manufacturers Announced Agreement to Phase Out Some Short-Chain PFAS from Food Packaging
On July 31, 2020, the US Food and Drug Administration (FDA) announced that manufacturers of certain short-chain PFAS used for grease-proofing in food packaging materials had voluntarily agreed to phase out sales of the substances for use as food contact substances over three years, beginning in January 2021.44 The substances subject to the phase-out are a subset of short-chain PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH). The FDA said new analyses of data regarding potential human health risks from chronic dietary exposure warranted further study, and that the phase-out agreement "balances uncertainty about the potential for public health risks with minimizing potential market disruptions to food packaging supply chains during the COVID-19 public health emergency."
EPA Finalized Significant New Use Rule for LCPFAC Substances that Encompasses Import of Certain Articles; Guidance Coming in December
On July 27, 2020, EPA published its final rule amending the Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances as well as the SNUR for perfluoroalkyl sulfonate chemical substances.45 The amended SNURs took effect on September 25. EPA Administrator Andrew Wheeler had signed the final rule more than a month earlier—on June 22, 2020—to comply with a deadline set in the National Defense Authorization Act of 2020. The final LCPFAC SNUR requires businesses to notify EPA at least 90 days before commencing manufacture, import, or processing of the specified chemical substances. The amended rule also requires notification prior to the import of articles containing certain LCPFAC substances as part of a surface coating, partially lifting a previous exemption for articles. EPA rejected requests that the SNUR include a safe harbor provision for importers of articles that can demonstrate their use was ongoing prior to the final rule's effective date or a de minimis threshold for determining "reasonable potential for exposure." EPA determined that to qualify as an "ongoing" use that is excluded from the SNUR, a use must have been occurring as of January 21, 2015, the date of publication of EPA's original proposed SNUR. EPA indicated, however, that it would "continue to engage with interested stakeholders" on the safe harbor and de minimis threshold issues. In October, Assistant Administrator Dunn said EPA would release proposed guidance for the LCPFAC SNUR in December 2020.46 She indicated the guidance would provide additional information about when the presence of LCPFAC in a surface coating requires notification by a potential importer of an article.
State Regulatory & Legislative Action
California Laws Will Prohibit Certain Chemicals in Cosmetics, Require Disclosure of Ingredients in Cosmetic and Menstrual Products
A law enacted on September 30, 2020 will ban the sale and manufacture in California of cosmetic products containing certain intentionally added ingredients, including PFOA, PFOS, certain other PFAS, formaldehyde, and mercury.47 The prohibition takes effect on January 1, 2025. Products that contain "a technically unavoidable trace quantity" of one of the listed chemicals due to impurities, the manufacturing process, storage, or migration from packaging are not subject to the prohibition.
A second law enacted on the same day will require manufacturers of cosmetic products to disclose to the California Department of Public Health a list of each intentionally added fragrance or flavor ingredient that are found on one of 22 specified designated lists.48
On September 29, 2020, Governor Newsom signed a bill that requires ingredient labels on boxes or packages of menstrual products sold in California, beginning on January 1, 2023.49 The law also requires that the ingredient information be posted on a website.
Our Advisory on "California Enacts New Ingredient Disclosure Laws for Feminine Hygiene and Cosmetic Products" covers the new California ingredient disclosure laws in greater detail.
Colorado to Ban PFAS-Containing Firefighting Foams at Public-Use Airports in 2023 and Require Certificates of Registration for Facilities that Use and Store PFAS
At the end of June 2020, Colorado enacted a law regulating PFAS-containing firefighting foams and PFAS more generally.50 One of the firefighting foam provisions amends a 2019 law that restricted use of the PFAS-containing foams for training and testing purposes. The 2020 amendments add requirements for testing activities to qualify for an exemption. The 2020 amendments will also ban use of PFAS-containing firefighting foams at Federal Aviation Administration-designated public-use airports in Colorado beginning January 1, 2023. The 2020 law also directs the Colorado Solid and Hazardous Waste Commission to establish a program for issuance of certificates of registration to facilities and fire departments that use or store PFAS and to establish standards for the capture and disposal of PFAS.
Maine Requires Reporting on PFOS-Containing Children's Products
Effective July 28, 2020, the Maine Department of Environmental Protection designated PFOS and certain PFOS salts as "priority chemicals" under its Safer Chemicals in Children's Products program.51 As a result, manufacturers and distributors of 10 categories of products that contain intentionally added PFOS or PFOS salts must report certain information to Maine DEP, including the amount and function of PFOS or its salts in the product, sales and distribution volumes, and "any other information the manufacturer or distributor deems relevant to the reporting of the PFOS or its salts for the Department's consideration, such as relevant independent scientific study on exposure specific to the amount of PFOS or its salts present in the finished product reported or product of similar functionality." The covered categories of products are: (1) child care article; (2) clothing; (3) footwear; (4) sleepwear; (5) toy; (6) cookware, tableware, reusable food and beverage containers; (7) cosmetics and personal care products; (8) craft supplies; (9) electronic devices; and (10) household furniture and furnishings. Reports are due 180 days after the July 28, 2020 effective date.
Massachusetts Set Single Drinking Water Standard for Sum of Six PFAS
On October 2, 2020, the Massachusetts Department of Environmental Protection (MassDEP) published its final drinking water regulations setting a maximum contaminant level (MCL) of 20 parts per trillion for the sum of six PFAS: perfluorooctane sulfonic acid (PFOS); perfluorooctanoic acid (PFOA); perfluorohexane sulfonic acid (PFHxS); perfluorononanoic acid (PFNA); perfluoroheptanoic acid (PFHpA); and perfluorodecanoic acid (PFDA).52 The regulations refer to this set of PFAS as "PFAS6." Beginning by the end of 2023, and once every three years thereafter, MassDEP must "perform a review of relevant developments in the science, assessment and regulation of PFAS in drinking water for the purpose of evaluating whether to amend [the MCL] in light of any advancements in analytical or treatment technology, toxicology and/or any other relevant information."
Michigan Adopted Drinking Water Limits for Seven PFAS
On July 27, 2020, regulations setting maximum contaminant levels for seven PFAS were filed with the Michigan Secretary of State.53 The MCLs are 6 ppt for PFNA, 8 ppt for PFOA, 400,000 ppt for perfluorohexanoic acid (PFHxA), 16 ppt for PFOS, 51 ppt for PFHxS, 420 ppt for PFBS, and 370 ppt for hexafluoropropylene oxide dimer acid (HFPO-DA) (a GenX compound). The Department of Environment, Great Lakes, and Energy said the standards would apply to approximately 2,700 public water supplies and result in the addition of 42 sites to a portfolio of sites undergoing investigation by the Michigan PFAS Action Response Team.
New Michigan Laws Restrict and Impose Requirements on Use of PFAS-Containing Firefighting Foam
On July 8, 2020, Michigan enacted two laws addressing firefighting foam that contains intentionally added PFAS. One law requires fire chiefs to report their use of such foams to the Michigan pollution emergency alert system "[i]mmediately after the end of a fire or other incident" at which a fire department uses such foams.54 The law also requires that the Department of Environment, Great Lakes, and Energy establish a program for the collection and proper disposal of firefighting foam concentrate containing intentionally added PFAS. The other bill prohibits use of PFAS-containing firefighting foam for training of firefighters and requires training until December 2023 on the proper use and handling of such firefighting foams.
With Regulatory Standards Held Up in Court, New Hampshire Enacted PFAS Maximum Contaminant Levels
In July, New Hampshire Governor Chris Sununu signed legislation that established maximum contaminant levels and ambient groundwater quality standards for four PFAS: PFOA (12 parts per trillion (ppt)), PFOS (15 ppt), PFHxS (18 ppt), and PFNA (11 ppt).55 The law authorizes the Department of Environmental Services (NHDES) to adopt different MCLs if necessary for the protection of human health. The law also creates programs to provide low-interest loans to (1) community water systems and non-profit, non-transient public water systems with exceedances of the PFAS MCLs for remediation efforts; and (2) publicly-owned and non-profit wastewater and/or wastewater residual treatment or storage facilities that are required to treat effluent and residuals to achieve PFAS standards. In addition, the law requires that insurers provide coverage for PFAS and perfluorinated compounds blood testing. As a result of the law's enactment, a New Hampshire court vacated a preliminary injunction that had been in place since November 2019 to enjoin enforcement of NHDES regulations that had established the same numeric standards for PFAS as were enacted by the legislature.56
New Jersey Adopted PFOA and PFOS Drinking Water Standards
Effective June 1, 2020, the New Jersey Department of Environmental Protection adopted a maximum contaminant level for PFOA of 0.014 µg/l and an MCL for PFOS of 0.013 µg/l.57 The amendments to the New Jersey Safe Drinking Water Act regulations also include monitoring requirements for PFOA and PFOS. In addition, NJDEP amended regulations concerning discharges of hazardous substances, groundwater quality standards, and private well testing. The regulatory amendments include requirements for testing of public and private wells for PFNA, as well as PFOA and PFOS. Amendments to the New Jersey Pollutant Discharge Elimination System rules added PFOA, PFOS, and PFNA to the Permit Application Testing Requirements/Pollutant Listings and the Requirements for Discharges to Ground Water. On October 1, a lawsuit challenging the standards was filed in New Jersey state court by a manufacturer, public utilities, and trade groups.58
Drinking Water Standards for PFOA, PFOS, and 1,4-Dioxane Took Effect in New York
Drinking water standards for 1,4-dioxane, PFOA, and PFOS took effect on August 26, 2020.59 The maximum contaminant levels adopted by the New York State Department of Health are 1.0 part per billion for 1,4-dioxane and 10.0 ppt for PFOA and PFOS. Adoption of the MCLs triggers monitoring obligations for public water systems. Systems serving 10,000 persons or more must begin monitoring within 60 days of adoption; water systems serving 3,300 to 9,999 people must begin monitoring within 90 days; and water systems serving fewer than 3,300 must begin monitoring within six months. The regulations also include a provision allowing a public water system to request to defer an MCL violation if the water system has a plan in place to achieve compliance. Water systems must request a deferral—which can be issued for up to two years with the potential for a one-year extension—within 90 days of publication of the notice of adoption.
Washington Identifies 11 Priority Consumer Products for Potential Regulation
On July 7, 2020, the Washington Department of Ecology completed the second phase of its implementation of its Safer Products for Washington program by submitting a report to the legislature that identified 11 priority consumer products.60 Ecology identified each of the priority consumer products as a significant source of or use of one of the priority chemicals designated by the 2019 law. The priority products are:
- Flame retardants: electric and electronic equipment (plastic device casings), recreational polyurethane foam products
- PCBs: paints and printing inks
- PFAS: carpet and rugs, leather and textile furnishings, aftermarket stain and water resistance treatments
- Phenolic compounds (bisphenols): food and drink cans (can linings), thermal paper
- Phenolic compounds (alkylphenol ethoxylates): laundry detergent
- Phthalates: vinyl flooring, personal care, and hygiene products (fragrance)
The next phase of the program involves making determinations about whether and how to regulate the products. Ecology is currently researching whether safer alternatives are available.
Emergency Rule Under Consideration to Implement New Restrictions on PFAS-Containing Firefighting Foam
On October 28, 2020, the Wisconsin Natural Resources Board considered a proposed emergency rule to implement requirements of a law enacted in February that bans the use and discharge, including for training purposes, of firefighting foam containing intentionally added PFAS.61 The prohibition took effect on September 1. The proposed rule includes provisions regarding appropriate containment, treatment, and disposal or storage measures for testing facilities, which are exempted from the ban; the proposed regulations also specify requirements for use and discharge of foam associated with emergency firefighting or fire prevention, as well as requirements for containment, treatment, disposal, and storage of PFAS-containing foam and foam materials generated by testing facilities.
*Margaret Barry also contributed to this newsletter.
© Arnold & Porter Kaye Scholer LLP 2020 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.
A copy of the draft monograph is available on the National Academies of Science website.
Natural Res. Def. Council, Inc. v. EPA, 961 F.3d 160 (2d Cir. 2020).
Sam LaGrone, Thornberry: Final NDAA Bill Won’t Be Ready Until After Election, USNI News (Sept. 9, 2020, 4:08 PM).
85 Fed. Reg. 13062 (Mar. 6, 2020).
News Release, EPA, EPA Releases Updated 2016 Chemical Data Reporting Rule Data (May 29, 2020).
85 Fed. Reg. 66230 (Oct. 19, 2020).
Exec. Order No. 13891, 84 Fed. Reg. 55235 (Oct. 15, 2019).
Ctr. for Envtl. Health et al., Petition to Require Health and Environmental Testing Under the Toxic Substances Control Act on Certain PFAS Manufactured by Chemours in Fayetteville, North Carolina (Oct. 13, 2020).
Assessing and Managing Chemicals Under TSCA: TSCA Section 21, EPA (last updated Nov. 12, 2019).
85 Fed. Reg. 55281 (Sept. 4, 2020).
85 Fed. Reg. 55283 (Sept. 4, 2020).
News Release, EPA, EPA Announces Plan to Reduce TSCA Fees Burden for Stakeholders (Mar. 25, 2020). EPA also issued a "no-action assurance" commitment signed by the head of the Agency's enforcement office making clear that EPA will not pursue enforcement actions against companies within these three categories for failures to "self-identify" as manufacturers. See 85 Fed. Reg. 20275 (Apr. 10, 2020).
Jeremy Bernstein, EPA Sends Plan To Overhaul TSCA Fee Program For White House Review, Inside TSCA (Oct. 15, 2020).
84 Fed. Reg. 36728 (July 29, 2019).
85 Fed. Reg. 37942 (June 24, 2020).
85 Fed. Reg. 48687 (Aug. 12, 2020).
85 Fed. Reg. 60456 (Sept. 25, 2020).
See Peer Review of the Draft Risk Evaluation of Asbestos, EPA (last updated Sept. 3, 2020).
See Peer Review of the Draft Risk Evaluation for Perchloroethylene, EPA (last updated Sept. 3, 2020).
See Peer Review of the Draft Risk Evaluation for Trichloroethylene (TCE), EPA (last updated June 2, 2020).
News Release, EPA, EPA Grants Manufacturer Request for Risk Evaluation of D4 (Oct. 7, 2020).
Possible Conditions of Use (COU) Table for Octamethylcyclotetra- siloxane (posted to Docket ID: EPA-HQ-OPPT-2018-0443 on October 8, 2020).
EPA Office of Inspector General, Rep. No. 20-P-0247, Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines (Aug. 17, 2020).
Stephen Lee, EPA Announces Major Reorganization of Chemical Safety Division, Bloomberg Law (Sept. 8, 2020, 3:41 PM).
Petition to Initiate a Proceeding to Issue a Procedural Risk Management Rule Under Section 6 of the Toxic Substances Control Act (June 3, 2020); see also Petition to Issue Procedural Risk Management Rule under TSCA Section 6, EPA (last updated Aug. 4, 2020).
Press Release, US Food & Drug Admin., FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging (July 31, 2020).
85 Fed. Reg. 45109 (July 27, 2020).
Rick Weber, Toxics Chief Says Guide for PFAS SNUR Coming in December for Comment, Inside TSCA (Oct. 20, 2020).
See 310 CMR 22: The Massachusetts Drinking Water Regulations, Mass.gov (Oct. 2, 2020).
See Press Release, Mich. Dep’t of Env’t, Great Lakes, & Energy, Michigan Adopts Strict PFAS in Drinking Water Standards (July 27, 2020) (regulations are codified at Mich. Admin. Code R 325.10101–R 325.12820).
See 52 N.J. Reg. 1165(b).
N.Y. Reg., vol. XLII, iss. 34, at 6 (Aug. 26, 2020) (codified at 10 N.Y.C.R.R. subpt. 5-1).
Wash. Dep’t of Ecol., 20-04-019, Priority Consumer Products Report to the Legislature (July 2020).
See PFAS-Containing Firefighting Foam, Wis. Dep’t of Natural Res. (last visited Oct. 22, 2020).