News
February 7, 2020

The Chemical Compound–February 2020

Legal Updates on High Priority Chemicals and Important Chemical-Regulatory Developments

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, such as perfluorinated chemicals (PFCs), hexavalent chromium, trichloroethylene (TCE), 1,2,3-Trichloropropane (TCP), and 1,4-dioxane, 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

» Litigation

  • Lawsuit Challenges FDA Denial of Requests to Revoke Authorization of Perchlorate in Food-Contact Materials
  • Federal Court Said It Would Apply Deferential Standard to EPA Denial of Petition to Add Asbestos to CDR Reporting
  • Federal Court Denied Summary Judgment in Case Challenging EPA Denial of Petition Seeking Prohibition of Fluoridation of Drinking Water
  • Ninth Circuit Said EPA Must Consider "Legacy Uses" and "Associated Disposals" in Risk Evaluations, Rejected Other Challenges to TSCA Framework Rules
  • Chemical Services Company Agreed to $45,000 Penalty to Resolve CDR Violations

» Federal Developments

Legislative Developments

  • Defense Appropriations Law Added 160 PFAS to TRI Reporting Program, Included Other PFAS Provisions
  • House Passed Bill to Regulate PFAS Under Major Environmental Statutes
  • House Committee Approved TSCA Amendments Banning Asbestos

Regulatory Developments

  • EPA Progress on TSCA Risk Evaluations for First 10 Chemicals: Seven Draft Evaluations, Four SACC Reports, and Systematic Review to Undergo Peer Review
  • EPA Released Updated "Working Approach" for New Chemical Determinations Under TSCA; New Webpages Provide Easier Access to New Chemical Notice Data
  • EPA Finalized Designation of High-Priority Substances for Risk Evaluation
  • EPA Released Preliminary Lists of Manufacturers and Importers Required to Pay Share of Risk Evaluation Costs for High-Priority Substances
  • RCRA Rulemaking Petition Seeks Designation of PFOS, PFOA, and GenX Wastes as Hazardous
  • EPA Issued PFOA and PFOS Cleanup Guidance
  • FDA Detected PFAS in One Food Sample Out of 88
  • EPA Updated List of Actions to Reduce Vertebrate Animal Testing
  • EPA Granted Manufacturer Requests for Risk Evaluations of Phthalates
  • EPA Denied Petition Seeking Hydrofluoric Acid Ban at Oil Refineries
  • National Academies of Sciences Released Critique of Defense Department's Proposed Exposure Limits for TCE
  • Defense Department Released Guidance for Determining When Further PFAS Investigation Is Warranted
  • EPA Released Systematic Review Protocol for PFAS Assessments; Regulatory Determinations on PFOA and PFOS Delayed into 2020
  • EPA Proposed Fix for Substantiation of Chemical Identity CBI Claims

» State Regulatory & Legislative Action

  • California
  • Connecticut
  • Maine
  • Massachusetts
  • Michigan
  • New Hampshire
  • New York
  • Ohio
  • Washington
  • Wisconsin

Litigation

Lawsuit Challenges FDA Denial of Requests to Revoke Authorization of Perchlorate in Food-Contact Materials

On October 29, 2019, Natural Resources Defense Council and five other organizations filed a lawsuit in the Southern District of New York to compel the US Food and Drug Administration (FDA) to ban the use of perchlorate in materials that contact food.1 The complaint alleged that since FDA approved use of perchlorate in certain food packaging in 2005, FDA's own research had demonstrated that levels of perchlorate "have spiked to significantly higher levels" and that perchlorate is "present in foods at levels that substantially increase the probability of serious harm." In 2017, FDA denied a petition seeking revocation of its authorization of perchlorate in food-contact articles and denied objections to the petition denial in April 2019. The plaintiffs assert that the denial of the petition was arbitrary, capricious, and not in accordance with the Federal Food, Drug, and Cosmetic Act.

Federal Court Said It Would Apply Deferential Standard to EPA Denial of Petition to Add Asbestos to CDR Reporting

A federal court in California denied EPA's motion to dismiss a lawsuit challenging the Agency's denial of a rulemaking petition to expand Chemical Data Reporting (CDR) reporting requirements to asbestos.2 The court dismissed, however, the plaintiffs' claim for de novo review of the denial under TSCA Section 21, finding that the rulemaking petition expressly sought modifications to an existing rule, not initiation of a new rule, and was therefore subject to the Administrative Procedure Act's more deferential arbitrary and capricious standard of review.

Federal Court Denied Summary Judgment in Case Challenging EPA Denial of Petition Seeking Prohibition of Fluoridation of Drinking Water

A federal court in California denied both sides' motions for summary judgment in a 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.3 The plaintiffs assert that ingestion of fluoride poses an unreasonable risk of neurotoxic harm to humans. The court found that the plaintiffs had "adequately alleged neurotoxic harm, in the form of headaches, to have Article III standing" and also rejected EPA's argument that the plaintiffs lacked prudential standing because they fell outside TSCA's zone of interests. The court found, however, that the evidence presented by the plaintiffs was not sufficient to establish that no reasonable juror could find in EPA's favor. In denying EPA's summary judgment motion, the court said it could not at this point rule on whether the plaintiffs failed to comply with TSCA's procedural and methodological requirements for risk evaluation and science-based decisions. The court also found that EPA had not made a factually undisputed showing that the plaintiffs failed to establish an unreasonable risk.

Ninth Circuit Said EPA Must Consider "Legacy Uses" and "Associated Disposals" in Risk Evaluations, Rejected Other Challenges to TSCA Framework Rules

On November 14, the Ninth Circuit vacated portions of EPA's Risk Evaluation Rule that excluded "legacy uses" and "associated disposals" from the conditions of use required to be considered when evaluating whether a chemical substance presents an unreasonable risk.4 The Risk Evaluation Rule is one of the "Framework Rules" under the amended TSCA. The Ninth Circuit dismissed or denied three other challenges to the rule. First, the court concluded that it lacked jurisdiction to consider the petitioners' argument that portions of the rule indicated EPA's intention to make risk determinations for individual uses rather than evaluate a substance's risks holistically. The court said this argument was not justiciable because the petitioners' "interpretation of what EPA intends to do and … resulting theory of injury are too speculative." Second, the court rejected the petitioners' argument that the rule contravened EPA's obligation under TSCA to consider all of a chemical's conditions of use. The court said language in the rule's preamble indicating that EPA might exclude certain activities from the conditions of a use on a case-by-case basis did not bind the agency and therefore was not reviewable final agency action. The court further concluded that the rule's actual provisions did not grant EPA authority to exclude conditions of use from consideration. Third, the Ninth Circuit found that EPA properly excluded "legacy disposal" from the conditions of use, concluding that "TSCA unambiguously does not require past disposals to be considered conditions of use."

In a separate order concerning challenges to other aspects of EPA's Framework Rules for prioritization and risk evaluation, the Ninth Circuit granted EPA's request for voluntary remand of three information-gathering provisions: (1) a provision that criminally penalizes submission of inaccurate or incomplete information to EPA; (2) a "relevancy" provision requiring manufacturers to include certain relevant information in requests for risk evaluations; and (3) a "consistency" provision requiring that such information in manufacturer requests be consistent with certain scientific standards.5 The court found that remaining challenges to two provisions—(1) a provision concerning the information sources EPA uses to prioritize chemicals for risk evaluation and (2) language in a provision regarding information considered for prioritization purposes—were without merit.

Chemical Services Company Agreed to $45,000 Penalty to Resolve CDR Violations

On October 23, 2019, EPA announced that a California chemical services company would pay a $45,000 civil penalty to settle alleged violations of CDR requirements.6 EPA said the company failed to timely submit forms disclosing its import of large quantities of two chemical substances between 2012 and 2015.

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Federal Developments

Legislative Developments

Defense Appropriations Law Added 160 PFAS to TRI Reporting Program, Included Other PFAS Provisions

On December 20, 2019, President Trump signed the National Defense Authorization Act of Fiscal Year 2020 (NDAA) (S. 1790) into law.7 The entirety of the bill's Title LXXIII is devoted to per- and polyfluoroalkyl substances (PFAS) and is referred to as the "PFAS Act of 2019." Although some PFAS provisions were ultimately deleted from the final bill—including provisions for PFAS to be designated as a hazardous substance pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act and requirements for PFAS drinking water standards—other broadly applicable provisions were included in the final bill, perhaps most notably a provision adding 160 PFAS chemicals to the list of substances covered by the Toxics Release Inventory (TRI), effective January 1, 2020. All manufacturers, processors, and users of these PFAS substances are now required to report them when the annual usage quantity is 100 pounds or more, and EPA must determine within the next five years whether revisions need to be made to the 100-pound threshold. TRI reports including the initial 160 PFAS chemicals are due July 1, 2021. The NDAA also provides for the addition of more PFAS chemicals to the TRI program in the coming years.

Shortly before the NDAA was enacted, EPA published an Advance Notice of Proposed Rulemaking (ANPRM) on December 4, 2019, opening a 60-day comment period for stakeholder submission of comments and information regarding which PFAS substances should be subject to TRI reporting.8 Although the NDAA arguably mooted a portion of the ANPRM, EPA is continuing to solicit comments on whether other PFAS substances should be subject to TRI reporting, as well as on appropriate reporting thresholds, PFAS categorization, and the availability of new information on the toxicity, persistence, and bioaccumulation of additional PFAS.9 Please see our recent Advisory for more information on these developments related to PFAS and the TRI program.

In addition, the NDAA requires EPA to finalize by June 22, 2022 a 2015 proposed rule that would expand the scope of the SNUR at 40 C.F.R. § 721.10536 covering certain long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances and eliminate an exemption to the SNUR at 40 C.F.R. § 721.9582 for import of chemical substances as part of carpets.10 EPA sent a proposed SNUR to the Office of Management and Budget in September 2019. The NDAA also directs EPA to issue a "data call" rule pursuant to Section 8(a) of TSCA by January 1, 2023 requiring PFAS manufacturers to submit information about each PFAS substance, including existing information concerning the environmental and health effects and estimates of the number of people exposed.

Other provisions in the NDAA require drinking water monitoring for PFAS; provide funding to states for addressing emerging contaminants, with a focus on PFAS; require the US Geological Survey to perform nationwide sampling to determine the concentration of highly fluorinated compounds in estuaries, lakes, streams, springs, wells, wetlands, rivers, aquifers, and soil; establish an interagency research program to investigate emerging contaminants; direct EPA to publish interim guidance on the destruction and disposal of PFAS and PFAS-containing materials; and fund an EPA study of PFAS effects on health and the environment and EPA work to develop new tools to characterize and identify PFAS in the environment, to evaluate remediation approaches for PFAS, and to develop tools and materials to communicate with the public about PFAS.

The NDAA included provisions restricting and regulating the military's use of fluorinated aqueous film-forming foams (AFFF) for firefighting, including by requiring a transition to a fluorine-free firefighting agent by October 2023. The uncontrolled release of fluorinated AFFF at military installations is prohibited by the NDAA, except for emergency response or for testing purposes, and use of AFFF for training purposes is also barred. In addition, the NDAA requires the Defense Logistics Agency to ensure that any food contact substances that are used to assemble and package meals ready-to-eat (MREs) do not contain PFAS. The law also imposes restrictions on the Defense Department's (DOD) disposal of PFAS materials and requires the Defense Department to maintain a website with information about the exposure of military members and families and their communities to PFAS. PFAS monitoring information will be shared with local governments and utilities under the NDAA and cooperative agreements between the DOD and states will be established to address PFAS contamination.

House Passed Bill to Regulate PFAS Under Major Environmental Statutes

On January 10, 2020, the House of Representatives passed H.R. 535, the PFAS Action Act of 2019, which would, among other things, compel EPA to list perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), and their salts as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act within a year and to determine within five years whether all PFAS substances should be listed as hazard substances. PFOS and PFOA would also have to be designated as hazardous air pollutants under the Clean Air Act, with EPA determining whether other PFAS substances should also be so designated. The bill would amend TSCA to require EPA to conduct toxicity testing for all PFAS substances and would require manufacturers and importers of PFAS substances to develop information for toxicity testing. The legislation also would impose a five-year prohibition on the manufacture, import, or processing of new PFAS substances. EPA would be required to establish drinking water standards within two years under the Safe Drinking Water Act (SDWA) for at least two PFAS: PFOA and PFOS. The bill would also establish a PFAS infrastructure grant program under the SDWA. Other provisions of the PFAS Action Act would require a labeling program for PFAS-free products, require preparation of guidance on reducing use of PFAS-containing firefighting foam and equipment, and regulate PFAS under the Clean Water Act.

House Committee Approved TSCA Amendments Banning Asbestos

On November 19, 2019, the House Energy and Commerce Committee approved a bill by a 47-1 vote that would ban asbestos.11 The legislation, known as the Alan Reinstein Ban Asbestos Now Act of 2019, would amend Section 6 of TSCA to prohibit the manufacture, processing, or distribution in commerce of asbestos or any mixture or article containing asbestos. The legislation would authorize exemptions for national security purposes where no feasible alternatives are available. The bill would also require preparation of a report on "legacy asbestos" to assess the presence of asbestos in existing buildings and the extent of exposure and risk to human health. The report would also assess and make recommendations regarding the sufficiency of the existing regulatory framework to protect from the risks of exposure to legacy asbestos.

Regulatory Developments

EPA Progress on TSCA Risk Evaluations for First 10 Chemicals: Seven Draft Evaluations, Four SACC Reports, and Systematic Review to Undergo Peer Review

Since our last Newsletter, EPA published draft risk evaluations for methylene chloride (in October 2019),12 N-Methylpyrrolidone (NMP) (in November 2019),13 and carbon tetrachloride (in January 2020),14 bringing its total number of draft risk evaluations to seven of the first ten which must be finalized by June 2020 under the current law (unless extensions in that deadline are considered).

The methylene chloride draft risk evaluation found potential unreasonable risk to workers, occupational non-users, consumers, and certain bystanders for certain conditions of use and no unreasonable risk for certain other conditions of use including domestic manufacture, processing as a reactant, and consumer use as brush cleaner.

The draft NMP risk evaluation identified potential unreasonable risk to workers and consumers under certain conditions of use and no unreasonable risk to the environment, bystanders or occupational non-users. The public comment periods on the draft evaluations ended on December 30, 2019 for methylene chloride and January 21 for NMP.

The draft risk evaluation for carbon tetrachloride determined that occupational non-users could be adversely affected by chronic inhalation exposure to carbon tetrachloride under certain conditions of use, resulting in a preliminary finding of potential unreasonable risk. However, the draft risk evaluation preliminarily found no unreasonable risk to the environment or to workers using appropriate personal protective equipment for any condition of use. Comments on the carbon tetrachloride draft risk evaluation are due by March 27, 2020.

Also since our last newsletter, the TSCA Science Advisory Committee on Chemicals (SACC) final peer review reports on previously issued draft risk evaluations were released for four chemicals: Pigment Violet 29 (PV29) (on September 30, 2019); 1,4-dioxane and Cyclic Aliphatic Bromide Cluster (HBCD) (on October 31, 2019); and 1-Bromopropane (on December 12, 2019).

The PV29 report included recommendations to improve TSCA systematic review in general, as well as PV-specific recommendations, which included suggestions that EPA improve the discussion on why available study data are adequate to reach the conclusions of "no unreasonable risk" from exposure to PV29.15 The report said SACC members were in general agreement that the information presented to support the conclusions outlined in the draft risk characterization was not sufficiently robust.

For 1,4-dioxane, the SACC report found that the draft risk evaluation did not adequately support the conclusion that 1,4-dioxane does not present an unreasonable risk of injury to health as it is used in manufacturing (import), processing (repackaging), and distribution in other downstream uses. The report also said many SACC members did not think it acceptable for EPA to defer concerns regarding consumer exposure or general public exposure through ambient air and water because "other environmental statutes administered by EPA adequately assess and effectively manage these exposures."16

The HBCD report said SACC members generally agreed they could not "assimilate the full content" of the HBCD systematic review in the time provided.17 The report included numerous recommendations for improvement, such as obtaining additional peer review of the models used, and identified a number of concerns with the draft risk evaluation, including a lack of quantification of uncertainties.

The 1-Bromopropane (1-BP) report indicated that the SACC found that in general the draft risk evaluation had "many attributes that represent significant improvements from previous TSCA assessments."18 However, the report also identified numerous uncertainties and concerns, including a lack of clarity "as to whether the consumer uses reflected are fully reflective of today's marketplace," a lack of reproductive and developmental data in the environmental exposure assessment, and a failure to consider cumulative or aggregate exposures.

EPA has said it will review the SACC's reports and determine how to incorporate the findings into final risk evaluations.

On December 13, EPA announced that it had contracted with the National Academies of Sciences to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations, an internal guidance document published by EPA in 2018 to guide the Agency's application of systematic review in the development of its first 10 risk evaluations.19 In its report on EPA's first draft risk evaluation (for PV29), the TSCA Science Advisory Committee on Chemicals noted that it had "strongly encouraged" EPA to obtain such a review "as soon as practical."20 In its announcement of the peer review, EPA said the review "will help provide EPA with important feedback on the agency's approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act risk evaluations."21 EPA said NAS would convene a public meeting and issue a final report by June 2020.

EPA Released Updated "Working Approach" for New Chemical Determinations Under TSCA; New Webpages Provide Easier Access to New Chemical Notice Data

In December 2019, EPA released a document outlining its updated approach to making determinations regarding new chemicals under Section 5 of TSCA.22 The document, "TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5" (Working Approach), builds on the framework set forth in a November 2017 document.23 The Working Approach document describes EPA's guiding principles and concepts as well as the decision-making logic and process for the Agency's review of Section 5 notices, which include premanufacture notices (PMNs), Microbial Commercial Activity Notices (MCANs), and Significant New Use Notices (SNUNs). The Working Approach document also discusses how EPA will apply the process to reach one of the five types of determinations EPA can make in response to Section 5 notices: (1) presents unreasonable risk; (2) not likely to present unreasonable risk; (3) insufficient information to permit a reasoned evaluation; (4) insufficient information to permit a reasoned evaluation and may present unreasonable risk; and (5) produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities or may be significant or substantial human exposure. The document includes a flowchart showing three questions on which EPA focuses during new chemical reviews. The three questions involve identifying the intended, known, and reasonably foreseen conditions of use; considering whether there is sufficient information to perform a reasoned evaluation; and evaluating whether a Significant New Use Rule (SNUR) can adequately address concerns regarding a reasonably foreseen use. The Working Approach document identifies some sources on which EPA relies to identify reasonably foreseen conditions of use and discusses the case-by-case nature of its determinations of information sufficiency and unreasonable risk. EPA published notice of the availability of the Working Approach document in the January 2, 2020 issue of the Federal Register and said it would accept comments on or before February 18, 2020.24

In November 2019, EPA announced the launch of new webpages containing more easily accessible information about new chemical notices.25 The webpages—which EPA intends to update monthly—provide information on PMNs, SNUNs, MCANs, Test Market Exemption Applications (TMEAs), Notices of Commencement of Manufacture or Import (NOCs), and test information submitted under Section 5 of TSCA.

EPA Finalized Designation of High-Priority Substances for Risk Evaluation

In the December 30, 2019 issue of the Federal Register, EPA published notice of its designation of 20 chemical substances as High-Priority Substances that will undergo risk evaluations.26 The notice officially initiates the risk evaluations, which must be completed within three years, with a potential six-month extension.27 The 20 High-Priority Substances are:

 1,3-Butadiene   Di-ethylhexyl phthalate (DEHP) 
 Butyl benzyl phthalate (BBP)   Di-isobutyl phthalate (DIBP)
 Dibutyl phthalate (DBP)  Ethylene dibromide
 o-Dichlorobenzene  Formaldehyde
 p-Dichlorobenzene  HHCB
 1,1-Dichloroethane  Tetrabromobisphenol A (TBBPA)
 1,2-Dichloroethane  Phosphoric acid, triphenyl ester (TPP) 
 trans-1,2-Dichloroethylene  Phthalic anhydride
 1,2-Dichloropropane  1,1,2-Trichloroethane
 Dicyclohexyl phthalate  Tris(2-chloroethyl) phosphate (TCEP)

 

EPA Released Preliminary Lists of Manufacturers and Importers Required to Pay Share of Risk Evaluation Costs for High-Priority Substances

Related to the designation of the initial High-Priority Substances, EPA published preliminary lists on January 27, 2020 of the manufacturers and importers that have been identified as subject to the fee to defray EPA's costs of conducting risk evaluations.28 The fees rule promulgated by EPA in October 2018 set a $1.35 million fee for each risk evaluation. Manufacturers and importers of the High-Priority Substances are required to pay the fee, and EPA noted in a December 19 call that this includes importers of articles containing the substance and manufacturers of the substance as a byproduct or impurity. EPA also indicated there would be no de minimis exception. During a 60-day comment period, which ends on March 27, 2020, manufacturers and importers are expected to "self-identify" if they have been left off the preliminary list but are a manufacturer or importer of the High-Priority Substance. EPA has stated its expectation that entities should "self-identify" even if they are importers of articles containing a High-Priority Substance or manufacturers or importers of a High-Priority Substance present only as an impurity or byproduct in a mixture of other substances. (Manufacturers that fail to self-identify may be subject to penalties.) Manufacturers also may submit a "certification of no manufacture" if a manufacturer is listed but has not manufactured the substance in the past five years or a "certification of cessation" if a manufacturer has ceased manufacture of the substance prior to initiation of the prioritization process for the applicable chemical substance and will not manufacture the substance again in the successive five years.29 EPA will publish a final list of manufacturers subject to the fee obligation no later than it publishes the final scope for the risk evaluation.30 The payment is due 120 days after publication of the final scope. Within 60 days of publication of the final scope, manufacturers have to notify EPA of any intent to form a consortium with other companies that are subject to the fee. The consortium members then decide among themselves how to allocate the fee. See our January 21 Advisoryfor more discussion of the risk evaluation fee and the obligation of importers of articles containing High-Priority Substances to pay the fee.

RCRA Rulemaking Petition Seeks Designation of PFOS, PFOA, and GenX Wastes as Hazardous

On January 15, 2020, five organizations submitted a petition for rulemaking to EPA requesting that the Agency regulate the management and disposal of certain PFAS wastes under the Resource Conservation and Recovery Act (RCRA) as hazardous wastes.31 The petition asked EPA to designate wastes containing PFOA, PFOS, or GenX chemicals as hazardous wastes subject to the RCRA requirements of Subtitle C: Toxicity Characteristic Wastes and Toxic Wastes. In addition, the petitioners requested that the hazardous waste designations for PFOA and PFOS "extend to cover the full chemical subclass of each—long-chain perfluoroalkyl carboxylates (LCPFACs) and long-chain perfluoroalkane sulfonates (LCPFASs), respectively—because the characteristics of LCPFACs and LCPFASs demonstrate that class-based regulation is appropriate." The petition described situations in which they asserted PFAS wastes had been improperly handled and disposed.

EPA Issued PFOA and PFOS Cleanup Guidance

On December 19, 2019, EPA's Office of Land and Emergency Management issued guidance for addressing groundwater contaminated with PFOA and/or PFOS at sites being investigated and remediated in federal cleanup programs, including under the Comprehensive Environmental Response, Compensation, and Liability Act and RCRA.32 The guidance, "Interim Recommendations to Address Groundwater Contaminated with Perfluorooctanoic Acid and Perfluorooctanesulfonate," recommends screening sites by using a groundwater screening level of 40 ng/l (ppt) and using EPA's Lifetime Drinking Water Health Advisories of 70 ppt as Preliminary Remediation Goals for groundwater that is a current or potential source of drinking water, where there are not state or tribal maximum contaminant levels or other applicable or relevant and appropriate requirements that are available and sufficiently protective.

FDA Detected PFAS in One Food Sample Out of 88

On December 20, 2019, the FDA posted the results of its second round of testing for 16 PFAS substances in foods.33 The PFAS testing was done on foods gathered for the FDA's ongoing Total Diet Study (TDS), which monitors contaminants and nutrients in the average U.S. diet. The second round of testing found only one sample—­ tilapia—out of 88 foods tested that had a detectable level of a PFAS substance, in this case PFOS. PFOS was also detected in a tilapia sample and in a ground turkey sample in the first round of testing. The FDA said that based on the best available current science, it had no indication that these PFOS levels present a human health concern. The FDA said it would use the testing to determine how to monitor PFAS in food going forward, including whether to include it in the TDS.

EPA Updated List of Actions to Reduce Vertebrate Animal Testing

On December 5, 2019, EPA announced updates to the Agency's list of alternative test methods or strategies that do not require new vertebrate animal testing. EPA refers to these methods and strategies as "New Approach Methodologies" or "NAMs." Changes to the list include 21 new test guidelines, six additional EPA policies, implementation of a new NAM in the TSCA New Chemicals Program, and identification of guidance documents related to reduction of animal testing for use. The updates are part of EPA's ongoing implementation of a strategic plan for development and implementation of NAMs.34 Section 4(h) of the amended TSCA directed EPA to prepare the strategic plan and to include and update the list of NAMs.35 On December 17, 2019, EPA held a conference at its headquarters that focused on NAMs.

EPA Granted Manufacturer Requests for Risk Evaluations of Phthalates

On December 2, 2019, EPA granted manufacturer requests under TSCA to undertake risk evaluations for two plasticizers, diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP). Both requests were submitted through the American Chemistry Council's High Phthalates Panel. Each request included two Chemical Abstracts Service Registry Numbers (CASRNs), and EPA said it would treat each pair of CASRNs as a category of chemical substances pursuant to Section 26(c) of TSCA. EPA has six months from the granting of the requests to issue final scope documents for the risk evaluations.36 Generally EPA intends to publish draft scopes within three months of initiation of a risk evaluation.37

EPA Denied Petition Seeking Hydrofluoric Acid Ban at Oil Refineries

On November 12, 2019, EPA published notice of its denial of a TSCA Section 21 petition from Public Employees for Environmental Responsibility (PEER) that requested a rulemaking to ban use of hydrofluoric acid in manufacturing processes at oil refineries.38 EPA said PEER's petition was "facially incomplete" because it lacked sufficient facts that would allow the Agency to make "threshold determinations necessary to substantively assess and grant a petition." In particular, EPA indicated that PEER "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."

National Academies of Sciences Released Critique of Defense Department's Proposed Exposure Limits for TCE

In November 2019, the National Academies of Sciences, Engineering, and Medicine (NAS) published a report on the DOD's review process for determining worker exposure limits to trichloroethylene (TCE).39 The committee convened by NAS to review DOD's approach agreed with DOD that an updated occupational exposure level (OEL) for TCE was needed but said it could not endorse DOD's process for deriving its proposed inhalation OEL of 0.9 parts per million. The report found that DOD's process was not consistent with best practices and made a number of recommendations for improvements, including different approaches to systematic review for problem formulation and hazard identification. The report suggested that DOD could consider using its proposed OEL as a temporary interim value.

Defense Department Released Guidance for Determining When Further PFAS Investigation Is Warranted

On October 15, 2019, the Department of Defense issued technical guidance for determining whether further investigation of PFOS, PFOA, and perfluorobutane sulfonic acid (PFBS) is warranted at sites receiving funding from the Environmental Restoration Account, Base Realignment and Closure Account, and Operation and Maintenance accounts for the National Guard. The guidance sets screening levels in tap water of 40 parts per trillion (ppt) for PFOA and PFOS where multiple PFAS are present or 400 ppt where only one of the substances is present. For PFBS, the screening levels are 40 parts per billion (ppb) where multiple PFAS are present or 400 ppb where only PFBS is present. The guidance indicated that DOD will use site-specific screening levels at National Priorities List sites, if such levels are provided.

EPA Released Systematic Review Protocol for PFAS Assessments; Regulatory Determinations on PFOA and PFOS Delayed into 2020

In November 2019, as part of the Agency's PFAS Action Plan, EPA released the Systematic Review Protocol (SRP) for toxicity assessments that the Agency will conduct under the Integrated Risk Information System for five PFAS substances: perfluorodecanoic acid (PFDA), perfluorononanoic acid (PFNA), perfluorohexanoic acid (PFHxA), perfluorohexanesulfonate (PFHxS), and perfluorobutanoic acid (PFBA).40 The SRP presented the methods for conducting the systematic reviews and dose response analyses and explained how the five substances had been prioritized for evaluation. The 45-day comment period on the SRP closed on December 23, 2019. EPA said its next step would be a proposed regulatory determination for PFOA and PFOS.41 EPA planned to issue the proposed determination by the end of 2019, but when the Agency submitted its draft determination to the Office of Management and Budget (OMB) in early December, Agency officials said it was likely that the OMB review would take months.42

EPA Proposed Fix for Substantiation of Chemical Identity CBI Claims

In response to a DC Circuit decision on the TSCA Inventory Notification (Active-Inactive) Requirements rule (Active-Inactive Rule),43 EPA proposed revisions to the Active-Inactive Rule as well as additional changes to the substantiation requirements for maintaining an existing confidential business information (CBI) claim for a specific chemical identity under TSCA that it proposed in April 2019. The proposed changes, published in the November 8, 2019 issue of the Federal Register, supplement EPA's April 23 proposed rule for reviewing CBI claims for specific chemical identities of substances identified as "active" pursuant to the Active-Inactive Rule.44 The proposal addressed the DC Circuit's finding that EPA arbitrarily eliminated substantiation questions regarding reverse engineering by adding two sets of questions: (1) Does this particular chemical substance leave the site of manufacture or processing in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity? and (2) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product? Manufacturers and processors who have already voluntarily submitted substantiation information prior to the finalization of the proposed rule will have to supplement their substantiation within 90 days (for a CBI claim in an NOA Form A) or 60 days (for a claim in an NOA Form B) of the effective date of the final rule. All manufacturers and processors who have not yet submitted substantiation will have to submit the required substantiation within 90 days of the effective date of the final rule (for those who asserted the CBI claim in an NOA Form A) or within 30 days of submitting an NOA Form B. EPA took comment on the supplemental notice of proposed rulemaking through December 9, 2019.

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State Regulatory & Legislative Action

California

California Court Allowed Challenge to Priority Product Listing of Spray Polyurethane Foam to Proceed

A California Superior Court found that the American Chemistry Council and General Coatings Manufacturing Corporation had adequately alleged facts showing that the California Department of Toxic Substances Control and other respondents exceeded their authority when listing spray polyurethane foam (SPF) systems as Priority Products in California's Safer Consumer Products program.45 The court noted that the petitioners had alleged that the listing did not distinguish between different types of SPF products, that products were listed that were not "consumer products," and that the respondents failed to establish a minimum threshold for exposure to SPF systems and to show how the products satisfied the criteria for listing. The court also found that the petitioners adequately alleged that the respondents rejected their proposed alternative of an enforceable consent agreement without proper analysis or explanation. The court also allowed the petitioners to proceed with a claim that the respondents violated the California Administrative Procedure Act by failing to prepare a final cost estimate for listing SPF systems as a Priority Product and with a California Environmental Quality Act claim.

California Proposed to Designate PFAS-Containing Leather and Textile Treatments and MMA-Containing Nail Products as Priority Products

In November 2019, DTSC proposed to name textile or leather treatments containing PFAS as a Priority Product in California's Safer Consumer Products program.46 The profile for the proposed Priority Product found that treatments for converted textiles or leathers were "widespread" in California homes and workplaces and can be significant sources of human and ecological exposure. The profile further found that degradation products of PFAS currently used for such treatments have the potential to cause significant and widespread adverse impacts to sensitive populations as well as to workers in various fields. The profile said that "[g]iven the known hazard traits of all members of [PFAS] class, replacing currently used PFASs in the treatments for converted textiles or leathers with other PFASs could constitute a regrettable substitution." The proposal therefore covers treatments containing any form of PFAS. DTSC took comment on the proposal through January 14, 2020.

On January 30, 2020, DTSC announced its proposal to designate nail products containing methyl methacrylate (MMA) as a Priority Product. DTSC also released a discussion draft of a product-chemical profile for the proposed Priority Product.47 The profile said exposure to MMA has the potential to cause or contribute to adverse health impacts, including dermal and respiratory toxicity. The profile noted that MMA continued to be detected in indoor air in nail salons despite FDA's removal of nail products containing 100% MMA from the market in the 1970s and California's 2015 prohibition on the use of MMA-containing nail products in licensed salons and cosmetology schools. The profile also said people applying MMA-containing products at home could experience exposures that were the same as or higher than nail technicians' exposures. DTSC scheduled a workshop on February 24, 2020 to discuss and receive public input on the profile. DTSC previously proposed and is still evaluating the listing of nail products containing toluene as a Priority Product.

California Continues to Consider Food Packaging with BPA, Phthalates, PFAS, and Styrene as Potential Priority Products

In October 2019, DTSC published preliminary reports on food packaging containing bisphenol-A (BPA) and its alternatives, ortho-phthalates (OPs), and PFAS.48 The reports are part of DTSC's process of evaluating whether to propose these chemical-product combinations as Priority Products under its Safer Consumer Products program. During a webinar on October 24, 2019, DTSC indicated it also might examine food packaging containing styrene as a chemical-product combination.49 DTSC held public workshops on BPA and OPs in food packaging in November 2019 and on PFAS in food packaging in January 2020.

Connecticut

Connecticut Released Final PFAS Action Plan

On November 1, 2019, the Connecticut Interagency PFAS Task Force released a final PFAS Action Plan outlining the state's strategy for minimizing exposure to and future releases of PFAS and identifying, assessing, and cleaning up historical PFAS releases.50 The plan recommends ongoing, short-term, and intermediate actions in these areas as well as actions related to education, outreach, and communication. The report also recommended five areas for legislative action, including measures related to regulating aqueous film-forming foams for firefighting, establishment of a Safe Drinking Water Advisory Council, a requirement that all water bottlers that sell bottled water in Connecticut test for PFAS in water products ready for consumption, potential disclosure requirements for products containing PFAS, and consideration of an extended producer responsibility program for certain PFAS-containing consumer products.

Maine

Maine Proposal Would Require Manufacturers to Disclose Presence of PFOS in Many Consumer Products

The Maine Department of Environmental Protection proposed to designate PFOS as a priority chemical under the state's Toxic Chemicals in Children's Products Law and to require manufacturer disclosure of the use of PFOS in certain product categories, including clothing, cosmetics, craft supplies, toys, cookware, and other household goods.51 The proposed rule applies not only to children's products but also to consumer products sold for indoor use or outdoor residential if a child under 12 years of age may have direct contact with them. The comment period for the proposed rule closed on February 3, 2020.

Maine Released PFAS Task Force Final Report

In January 2020, the Maine PFAS Task Force released its final report on "Managing PFAS in Maine."52 The Task Force, which was created by a March 2019 executive order, made recommendations in eight priority areas: safe drinking water, food supply, identification and investigation of PFAS contaminants in the environment, identification and reduction of uses of PFAS, responsible waste management, improved public education about PFAS, promotion of federal action, and funding for state agencies.

Massachusetts

Massachusetts Department of Environmental Protection Proposed PFAS Drinking Water Rules

In the December 27, 2019 issue of the Massachusetts Register, the Massachusetts Department of Environmental Protection published proposed regulations that would establish a "Total PFAS" maximum contamination level (MCL) of 20 ng/l (ppt) for six substances: PFOS; PFOA; PFHxS; PFNA; perfluoroheptanoic acid (PFHpA); and PFDA. If the sum of the concentrations of each of the substances exceeds the MCL, notice to consumers would be required, and if a running quarterly average exceeds the Total PFAS MCL, actions to reduce concentrations must be taken. The regulations would require initial monitoring for water systems and then routine monitoring, the scope of which would depend on the results of previous monitoring. A deadline of February 28, 2020 was set for written comments.

Michigan

Michigan Took Public Comment on Drinking Water Standards for Seven PFAS

On November 14, 2019, the Environmental Rules Review Committee (ERRC) allowed the rulemaking for proposed drinking water standards for seven PFAS chemicals to proceed to a public hearing.53 The ERRC said it would continue to oversee the rulemaking process rather than authorizing the rulemaking to continue without future ERRC oversight. The proposed rule would establish the following maximum contaminant levels:

 Hexafluoropropylene oxide dimer acid (GenX, HFPO-DA)   370 ng/l
 Perfluorobutane sulfonic acid (PFBS)  420 ng/l
 Perfluorohexane sulfonic acid (PFHxS)  51 ng/l
 Perfluorohexanoic acid (PFHxA)  400,000 ng/l 
 Perfluorononanoic acid (PFNA)  6 ng/l
 Perfluorooctane sulfonic acid (PFOS)  16 ng/l
 Perfluorooctanoic acid (PFOA)  8 ng/l

 

New Hampshire

New Hampshire Court Barred PFAS Water Standards, Citing Likelihood that State Failed to Conduct Adequate Cost-Benefit Analysis

A New Hampshire trial court enjoined the New Hampshire Department of Environmental Services (NHDES) from implementing maximum contaminant levels and ambient groundwater quality standards for four PFAS substances: PFOA, PFOS, PFNA, and PFHxS.54 The court found that the plaintiffs had shown a likelihood of success on the merits of their claim that NHDES did not conduct an adequate cost-benefit analysis as required by the New Hampshire Safe Drinking Water Act. The court found, however, that the plaintiffs did not establish a likelihood of success on the merits of claims that the standards constituted an unfunded mandate in violation of the New Hampshire constitution and state law and a claim that NHDES did not give adequate notice of the final standards, which were lower than the proposed standards. The court stayed its order until December 31, 2019 because "the legal issues raised by Plaintiffs' challenge are complex, the important of public health is paramount and the expense imposed by the proposed rule is significant." On December 27, the state asked the New Hampshire Supreme Court to hear an appeal of the preliminary injunction. The state has also asked the trial court to continue the stay of its order. Plaintiffs are seeking to cross-appeal.

New York

New York to Restrict 1,4-Dioxane in Cosmetic, Personal Care, and Cleaning Products

A New York law enacted on December 9, 2019 specifies limits on trace concentrations of 1,4-dioxane in household cleansing, personal care, and cosmetic products beginning at the end of 2022.55 For household cleansing and personal care products, such concentrations shall not exceed two parts per million (ppm) by December 31, 2022 and 1 ppm by December 31, 2023. In cosmetic products, trace concentrations may not exceed 10 ppm by December 31, 2022. The New York State Department of Environmental Conservation will conduct biannual reviews to determine whether the maximum concentrations should be further reduced. The law authorizes temporary waivers if manufacturers can prove they have taken steps to reduce the presence of 1,4-dioxane and are unable to comply with the law's restrictions.

New York Governor Signed Law Restricting PFAS Firefighting Foams

Beginning on March 22, 2020, New York will ban the use for training purposes of Class B firefighting foams containing intentionally added PFAS.56 Class B firefighting foams are foams designed to extinguish flammable liquid fires. New York will also ban the sale and distribution of PFAS-containing firefighting foams beginning on that date. The law provides for some exceptions for use of firefighting foams at certain fuel storage and distribution facilities, oil refineries, and chemical plants and where federal law requires inclusion of PFAS chemicals. Under the new law, manufacturers and sellers of firefighting personal protective equipment containing PFAS chemicals must provide written notice to purchasers at the time of sale.

New York Legislature Sent Comprehensive Chemicals Bill to Governor

On December 30, 2019, the legislature sent a bill to Governor Andrew M. Cuomo that would establish a comprehensive program to regulate toxic chemicals in children's products. Both houses of the legislature passed the bill in April.57 As of January 31, the governor had not taken action on the bill, and a failure to act by February 7 would have the same effect as a veto. The proponents of the bill noted that New York currently regulates use of dangerous chemicals on a chemical-by-chemical basis and that this legislation is modeled after programs in other states such as California, Maine and Washington that have more comprehensive policies. The legislation would designate chemicals of concern and dangerous chemicals, require manufacturers to report on the presence of such chemicals in children's products, and ban the sale of children's products containing certain chemicals. 

New York Revised Proposal for PFOA, PFOS, 1,4-Dioxane MCLs Includes Flexibility for Water Systems

On January 22, 2020, the New York State Department of Health (NYSDOH) published notice of its revised proposal to establish maximum contaminant levels for PFOA, PFOS, and 1,4-dioxane. The proposed MCLs for PFOA and PFOS as individual contaminants are 10 parts per trillion. The proposed MCL for 1,4-dioxane is 10 parts per billion. These values are the same as the proposed MCLs in the July 2019 original proposal and are consistent with the December 2018 recommendations of the Drinking Water Quality Council. Testing of New York State public water systems from 2013 through 2015 found that 11% of statewide systems—and 51% of systems on Long Island—had 1,4-dioxane levels above the proposed MCL. Of the 278 public water systems NYSDOH sampled between 2015 and 2018, 34 systems had PFOA levels exceeding the proposed MCL and 24 systems had PFOS levels exceeding the MCL. NYSDOH's revised proposal provides for a process by which public water systems can request a deferral of an MCL violation for up to two years, with a potential one-year extension, if the systems have plans in place to achieve compliance with the MCL. The 45-day comment period on the revised proposal ends on March 9, 2020.

Ohio

Ohio to Test Drinking Water for 90% of Population for PFAS

On December 2, 2019, the Ohio Environmental Protection Agency and Ohio Department of Health announced the release of a statewide action plan to address the potential presence of PFAS in drinking water.58 Implementation of the plan will involve testing 1,500 public water systems that supply drinking water for approximately 90% of Ohio's population. If PFAS chemicals are detected, the agencies will notify public water systems and private water systems owners and, if action levels are exceeded, public water systems will notify consumers. The type of actions the agencies and water systems will take in response to detection ranges from developing monitoring approaches and addressing PFAS sources, if PFAS is detected, to source management and treatment, if PFAS is detected above action levels. The action plan uses EPA's Health Advisory Levels of 70 ppt for PFOA and PFOS and establishes action levels for four additional PFAS chemicals (GenX (700 ppt), PFBS (140,000 ppt), PFHxS (1440 ppt), and PFNA (21 ppt)) based on EPA's established Drinking Water Equivalent Level method and toxicity data. The agencies hope that sampling will be completed by the end of 2020.

Washington

Washington Ban on PFAS Food Packaging Delayed as State Continues to Assess Alternatives

In December 2019, the Washington Department of Ecology (Ecology) announced that a ban on PFAS in food packages made of paper, paperboard or other plant fibers would be delayed past January 1, 2022 because Ecology had not completed its assessment of available alternatives.59 The law banning such packaging conditioned the 2022 effective date on a finding by January 1, 2020 that safer alternatives are available.60 In a webinar on January 28, 2020, Ecology said it hoped to finish its alternatives analysis—which is looking at food wrappers, sleeves, bags, and liners as well as dinnerware and takeout containers—by the end of 2020.61 The law provides that the ban would take effect two years after submission to the legislature of a report finding that safer alternatives are available.62

Wisconsin

Wisconsin Legislature Passed Ban on PFAS Firefighting Foams

A bill passed by the Wisconsin State Senate and Assembly on January 21, 2020 would prohibit the use or discharge of Class B firefighting foams containing intentionally added PFAS, except for emergency firefighting or fire prevention operations or for certain testing purposes.63 Notification and safety data sheet requirements would apply for the exempted uses. The legislature did not accept amendments that would have regulated PFAS more broadly.64

Wisconsin Natural Resources Board Gave Go-Ahead for PFOA and PFOS Standards

On January 22, 2020, the Wisconsin Natural Resources Board voted to allow the permanent rulemaking process to go forward for the establishment of maximum contaminant levels, human health surface water quality criteria, and discharge limitations for PFOA and PFOS and potentially other PFAS.65

*Margaret Barry also contributed to this newsletter.

Return to Table of Contents

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.

  1. Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin., No. 1:19-cv-10005 (S.D.N.Y.).

  2. Asbestos Disease Awareness Org. v. Wheeler, 2019 U.S. Dist. LEXIS 198631 (N.D. Cal. Nov. 15, 2019).

  3. Food & Water Watch, Inc. v. U.S. Envtl. Prot. Agency (EPA), No. 3:17-cv-02162-EMC (N.D. Cal. Dec. 30, 2019).

  4. Safer Chems., Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019).

  5. Safer Chems., Healthy Families v. EPA, 2019 U.S. App. LEXIS 33999 (9th Cir. Nov. 14, 2019).

  6. News Release, EPA Region 9, U.S. EPA Settles Chemical Data Reporting Violations with Miles Chemical Company (Oct. 23, 2019).

  7. See Pub. L. No. 116-92, 133 Stat. 1198.

  8. See 84 Fed. Reg. 66369 (Dec. 4, 2019); Toxic Release Inventory (TRI Program), Advance Notice of Proposed Rulemaking: Adding Certain PFAS to the TRI Chemical List, EPA.

  9. The comment period is open until February 3, 2020.

  10. See 80 Fed. Reg. 2885 (Jan. 21, 2015).

  11. H.R. 1603, 116th Cong. (2019).

  12. 84 Fed. Reg. 57866 (Oct. 29, 2019).

  13. 84 Fed. Reg. 60087 (Nov. 7, 2019).

  14. 85 Fed. Reg. 4659 (Jan. 27, 2020); EPA, EPA Doc. No. EPA-740-R1-8014, Draft Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-) CASRN: 56-23-5 (Jan. 2020).

  15. TSCA Science Advisory Committee on Chemicals, Meeting Minutes and Final Report, No. 2019-01, A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Peer Review for EPA Draft Risk Evaluation of C.I. Pigment Violet 29, June 18-21, 2019 {hereinafter PV29 SACC Report}.

  16. TSCA Science Advisory Committee on Chemicals, Meeting Minutes and Final Report, No. 2019-02, Peer Review for 1,4-Dioxane and Cyclic Aliphatic Bromide Cluster (HBCD), July 29 – August 2, 2019.

  17. See id.

  18. TSCA Science Advisory Committee on Chemicals, Meeting Minutes and Final Report, No. 2019-03, Peer Review for the United States Environmental Protection Agency (EPA) Draft Risk Evaluation for 1-Bromopropane (1-BP), September 10-12, 2019.

  19. EPA, EPA Doc. No. 740-P1-8001, Application of Systematic Review in TSCA Risk Evaluations (May 2018).

  20. PV29 SACC Report, supra note 15, at 25.

  21. Press Release, EPA, EPA Initiates Peer Review of TSCA Systematic Review Approach (Dec. 13, 2019).

  22. EPA, TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5 (Dec. 2019).

  23. EPA, New Chemicals Decision-Making Framework: Working Approach to Making Determinations under section 5 of TSCA (Nov. 6, 2017).

  24. 85 Fed. Reg. 99 (Jan. 2, 2020).

  25. New Chemical Notices Received by EPA, EPA, (last updated Nov. 12, 2019).

  26. 84 Fed. Reg. 71924 (Dec. 30, 2019).

  27. 15 U.S.C. § 2605(b)(4)(G).

  28. 85 Fed. Reg. 4661 (Jan. 27, 2020).

  29. 40 C.F.R. § 700.45(b)(4), (5).

  30. 40 C.F.R. § 700.45(b)(7).

  31. Green Sci. Pol’y Inst. et al., Petition for Rulemaking: RCRA Regulation of Wastes Containing Long-Chain PFAAs and GenX Chemicals (Jan. 15, 2020).

  32. EPA, OLEM Directive No. 9283.1-47, Interim Recommendations to Address Groundwater Contaminated with Perfluorooctanoic Acid and Perfluorooctanesulfonate (Dec. 19, 2019).

  33. Constituent Update, Ctr. for Food Safety & Applied Nutrition on Food, Dietary Supplements, and Cosmetics, U.S. Food & Drug Admin., FDA Makes Available Results from Second Round of Testing for PFAS in Foods from the General Food Supply (Dec. 20, 2019).

  34. EPA, EPA Doc No. EPA-740-R1-8004, Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program (June 22, 2018).

  35. 15 U.S.C. § 2603(h)(2)A).

  36. See 40 C.F.R. § 702.41(c)(8).

  37. See 40 C.F.R. § 702.41(c)(7)(ii).

  38. 84 Fed. Reg. 60986 (Nov. 12, 2019).

  39. Nat’l Acads. of Sci., Eng’g, & Med., Review of DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene (2019).

  40. 84 Fed. Reg. 60393 (Nov. 8, 2019).

  41. News Release, EPA, EPA Continues Progress Under PFAS Action Plan (Nov. 7, 2019).

  42. David Schultz, EPA’s Public Disclosure of PFAS Regulation Plan Delayed, Bloomberg Env’t (Dec. 4, 2019.

  43. Envtl. Def. Fund v. EPA, 922 F.3d 446 (D.C. Cir. 2019).

  44. 84 Fed. Reg. 60363 (Nov. 8, 2019); 84 Fed. Reg. 16826 (Apr. 23, 2019).

  45. Am. Chem. Council v. Cal. Dep’t of Toxic Substances Control (DTSC), No. 19CECG02938 (Cal. Super. Ct. Jan. 15, 2020).

  46. DTSC & Cal. Envtl. Prot. Agency (CalEPA), Product – Chemical Profile for Treatments Containing Perfluoroalkyl or Polyfluoroalkyl Substances for Use on Converted Textiles or Leathers(Discussion Draft) (Nov. 2019).

  47. DTSC & CalEPA, Product-Chemical Profile for Nail Products Containing Methyl Methacrylate (MMA) (Discussion Draft) (Feb. 2020).

  48. DTSC & CalEPA, Work Plan Implementation: Food Packaging with Perfluoroalkyl and  Polyfluoroalkyl Substances (PFASs) (Oct. 24, 2019); DTSC & CalEPA, Work Plan Implementation: Bisphenol A and its Alternatives in Food Packaging (Oct. 2019); DTSC & CalEPA, Work Plan Implementation: Phthalates in Food Packaging (Oct. 2019).

  49. DTSC & CalEPA, Work Plan Implementation Update: Food Packaging Project (Oct. 24, 2019); Lisa Martine Jenkins, California Narrows Field of Food Contact Substances for Possible SCP Action, ChemicalWatch (Oct. 30, 2019).

  50. Conn. Interagency PFAS Task Force, PFAS Action Plan (Nov. 1, 2019).

  51. Chapter 890, Designation of PFOS as a Priority Chemical - Reopen Comment Period, Public Hearing Scheduled, Me. Dep’t of Envtl. Prot.

  52. Me. PFAS Task Force, Managing PFAS in Maine: Final Report from the Maine PFAS Task Force (Jan. 2020).

  53. See Drinking Water Rule Promulgation, Mich. Dep’t of Env’t, Great Lakes, & Energy, (last visited Jan. 27, 2020); Paula Gardner, Proposed PFAS Standards for Drinking Water Now Head to Michigan Residents for Comment, MLive.com (Nov. 14, 2019).

  54. Plymouth Vill. Water & Sewer Dist. v. Scott, 2019 N.H. Super. LEXIS 18 (N.H. Super. Ct. Nov. 26, 2019).

  55. 2019 N.Y. Laws of N.Y. 613 (S4389-B).

  56. 2019 N.Y. Laws of N.Y. 702 (S439-A).

  57. 2019 N.Y. Legis. S501-B.

  58. Ohio Envtl. Prot. Agency & Ohio Dep’t of Health, Ohio Per- and Polyfluoroalkyl Substances (PFAS) Action Plan for Drinking  Water (Dec. 2019); News Release, Mike DeWine, Governor of Ohio, Ohio Releases Statewide PFAS Action Plan for Drinking Water (Dec. 2, 2019).

  59. Emily C. Dooley, First-in-Nation PFAS Paper Food Ban Delayed in Washington State, Bloomberg Env’t (Dec. 19, 2019, 3:58 PM).

  60. RCW 70.95G.070(4).

  61. Sylvia Carignan, Washington State Expands Search for PFAS-Free Food Containers, Bloomberg Env’t (Jan. 28, 2019, 3:43 PM).

  62. RCW 70.95G.070(5).

  63. 2019 S.B. 310.

  64. See Mitchell Schmidt, Senate Votes to Restrict Use of PFAS in Firefighting Foam, Wis. St. J. (Jan. 23, 2020).

  65. See Press Release, Wis. Dep’t of Natural Res., Wisconsin Natural Resources Board Approves DNR Effort to Create New PFAS Standards (Jan. 22, 2020).

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