News
January 28, 2019

The Chemical Compound—January 2019

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 EPA 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

» Impact of the Government Shutdown

» Litigation

  • In re Aqueous Film-Forming Foams Products Liability Litigation
  • Challenge to EPA's Failure to Issue Final TSCA Regulation for Methylene Chloride
  • Challenge to TSCA Risk Evaluation & Risk Prioritization Rules

» Federal Developments

  • Alexandra Dunn Confirmed as Assistant Administrator for EPA's Office of Chemical Safety & Pollution Prevention
  • Andrew Wheeler Nominated to Serve as EPA Administrator
  • EPA Releases Draft Risk Evaluation for Pigment Violet 29
  • National PFAS Management Plan

» TSCA Regulatory Actions

  • EPA Releases First List of Unique Identifiers
  • EPA Publishes Draft Toxicity Assessments for GenX and PFBS
  • Office of Management and Budget Reviewing Methylene Chloride Rules
  • PFAS Groundwater Cleanup Recommendations Likely to Reflect EPA Health Advisory

» Legislative Developments

  • America's Drinking Water Infrastructure Act Becomes Law
  • Legislation Introduced to Designate PFAS Chemicals as Hazardous Substances Under CERCLA

» State Regulatory & Legislative Action

  • Alaska
  • California
  • Michigan
  • New Hampshire
  • New York

Impact of the Government Shutdown

On January 25, 2019, President Trump signed a three week continuing resolution to fund the federal government through February 15. The Environmental Protection Agency (EPA), which had not been funded since December 28, 2018, had been operating with less than one percent of its staff. During the shutdown, EPA was permitted to undertake only activities such as conducting response actions at Superfund sites where failure to take action would "pose an imminent threat to human life," and supporting state and local agencies in responding to environmental emergencies.1 Many other activities were put on hold.

Numerous EPA actions are likely to be delayed as a result of the lapse in appropriations. For example, EPA did not process applications for the manufacture of new chemicals, or exemptions from pre-manufacture notice (PMN) reporting during the shutdown. EPA is required to review PMN applications for new chemicals within 90 days of receipt,2 for test-marketing exemptions within 45 days,3 and for low volume, and low release and low exposure exemptions within 30 days of receipt.4 If EPA fails to complete its review within the relevant time period, it is required to refund fees paid by the submitters.5

Neither TSCA nor its implementing regulations provide instruction about the impact of a government shutdown on TSCA Section 5 deadlines. However, EPA actions following previous government shutdowns shed light on how EPA is likely to proceed this time. Following the 1995-1996 and 2013 government shutdowns, EPA published Federal Register notices extending the review period for PMNs and PMN exemption applications.6 In extending the review period, EPA relied on its authority under Section 5(c) of TSCA, which gives EPA the power to unilaterally extend the review period for PMNs by up to 90 days.7 TSCA regulations qualify this authority, stating that EPA may extend the notice period "at any time during the notice review period,"8 therefore raising questions about whether EPA may extend the review period if it has already expired during the government shutdown (though it does not appear that EPA has faced pushback on this basis in the past).

EPA is likely to again extend the review period for PMNs and exemptions. If this occurs: (1) PMNs and exemptions submitted during the shutdown would likely be deemed to have been received by EPA on the day that the Agency reopens; and (2) the review periods for PMNs and exemptions received by EPA prior to the beginning of the government shutdown would likely be extended by the length of the shutdown (35 days).9

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Litigation

In re Aqueous Film-Forming Foams Products Liability Litigation

On December 7, 2018, the United States Judicial Panel on Multidistrict Litigation (the Panel) centralized 75 lawsuits from across the country involving claims of PFC contamination from aqueous film-forming foams (AFFF).10 The cases have been transferred to Judge Richard M. Gergel in the District of South Carolina. In September 2018, Tyco Fire Products and Chemguard filed a motion to centralize these actions in the Southern District of New York. This motion was followed shortly thereafter by a motion from 3M Company which sought to include in the multidistrict litigation (MDL) nine actions involving PFCs outside of the context of AFFF in which 3M was also named as a defendant. The Panel granted in part the motion from Tyco Fire Products and Chemguard, centralizing the AFFF cases outlined in the parties' motion in the District of South Carolina, but declining to include the non-AFFF cases in the MDL as 3M Company had requested. With respect to the AFFF cases, the Panel held that these actions had common factual questions, including allegations of the "toxicity of PFOA and PFOS and their effects on human health; the chemical properties of these substances and their propensity to migrate in groundwater supplies; the knowledge of the AFFF manufacturers regarding the dangers of PFOA and PFOS; [and] their warnings, if any, regarding proper use and storage of AFFFs." On the other hand, the non-AFFF cases were held to be "quite different" from the AFFF cases, and the Panel held that including these cases in the MDL could cause it to become "unwieldy."

Challenge to EPA's Failure to Issue Final TSCA Regulation for Methylene Chloride

Several environmental non-governmental organizations and individual plaintiffs have filed a lawsuit against EPA in the District of Vermont challenging EPA's failure to finalize its TSCA Section 6(a) rule regulating the use of methylene chloride-containing paint and coating removers.11 The plaintiffs are bringing the lawsuit under Section 20(a)(2) of TSCA, the statute's citizen suit provision.12 The plaintiffs argue that, under Section 6(a) of TSCA, EPA is required to issue a rule restricting the use of any substance that EPA determines presents an unreasonable risk of injury, and that EPA has violated Section 6(a) by failing to publish its final rule for methylene chloride. Plaintiffs seek a declaration from the court that, by failing to issue the final rule, EPA has not performed its "non-discretionary duty" under TSCA Section 6(a). The plaintiffs also seek an order requiring EPA to finalize the Section 6(a) rule to "ban" the use of methylene chloride-containing paint and coating removers and to file a civil action under Section 7 of TSCA (which allows EPA to file a civil action requesting relief to address "imminently hazardous chemical substance[s]").13 As discussed in further detail below, EPA sent its final Section 6(a) rule for methylene chloride-containing paint and coating removers to the White House Office of Management and Budget (OMB) for review in December 2018.

Challenge to TSCA Risk Evaluation & Risk Prioritization Rules

The Ninth Circuit partially granted EPA's request to remand three provisions of its Risk Evaluation Rule on December 18, 2018.14 In August, EPA moved to remand provisions of its Risk Evaluation Rule relating to how the Agency collects and analyzes information in the context of risk evaluations (40 C.F.R. §§ 702.37(b)(4), (b)(6)) and a provision imposing penalties upon persons who submit "inaccurate, incomplete, or misleading information pursuant to a risk evaluation" (40 C.F.R. § 702.31(d)).15 Plaintiff Safer Chemicals Healthy Families opposed EPA's request to remand the provisions of the rule relating to the collection and analysis of information relating to risk evaluations, but did not oppose EPA's request to remand the provision relating to criminal penalties.16 The Ninth Circuit granted EPA's request to remand the criminal penalties provision, but referred EPA's request to remand the provisions relating to the collection and analysis of information in the context of risk evaluations to the merits panel.

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Federal Developments

Alexandra Dunn Confirmed as Assistant Administrator for EPA's Office of Chemical Safety & Pollution Prevention

On January 2, 2019, Alexandra Dunn was unanimously confirmed by the US Senate as the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention. Ms. Dunn previously served as Regional Administrator for EPA Region 1.17 The Senate Committee on Environment and Public Works held a confirmation hearing for Ms. Dunn on November 29, 2018.18 During the confirmation hearing, many senators focused their questioning of Ms. Dunn on the implementation of TSCA. Specifically, numerous senators asked Ms. Dunn about the status of EPA's final TSCA Section 6(a) rule to regulate the use of methylene chloride in paint and coating removers. Additionally, several senators expressed concern to Ms. Dunn about EPA's exclusion of reasonably foreseen uses from the scopes of risk evaluations being conducted under TSCA. Ms. Dunn committed to conducting risk evaluations in accordance with the law.

Following Ms. Dunn's confirmation hearing, Acting EPA Administrator Andrew Wheeler sent a letter to Senator Carper, the Ranking Member on the Senate Committee on Environment and Public Works, outlining steps that the Agency intended to take to address concerns about TSCA raised by Senator Carper and others during Ms. Dunn's confirmation hearing.19 Specifically, Acting Administrator Wheeler committed that EPA would: (1) begin to publish PMNs and their attachments (including health and safety studies) within 45 days of receipt; (2) publish an updated version of its New Chemicals Decision-Making Framework during 2019 and seek public comment on the updated version; (3) submit its Systematic Review Method to the National Academy of Science for peer review, and seek peer review of the Agency's collection and evaluation of data in the first ten risk evaluations conducted under the amended TSCA; and (4) provide 60 days for public comment on each of the first ten risk evaluations (as opposed to the 30 days required by TSCA),20and to stagger the release of the first ten risk evaluations to enable interested parties to comment more readily on multiple assessments.

Andrew Wheeler Nominated to Serve as EPA Administrator

On November 16, 2018, President Trump announced his nomination of Andrew Wheeler as EPA Administrator.21 Andrew Wheeler is currently serving as the Acting Administrator of the EPA. He assumed this position in July 2018 following the resignation of Scott Pruitt.22 In an interview with the Washington Post in late November, Acting Administrator Wheeler discussed EPA's long-anticipated National Per- and Polyfluoroalkyl Substances (PFAS) Management Plan, describing it as a strategy to "help communities reach drinking water standards and protect them on PFOA and PFOS issues."23 Acting Administrator Wheeler also announced that EPA intends to release the National PFAS Management Plan in early 2019.24

Acting Administrator Wheeler's confirmation hearing was held on January 16, 2019. During the hearing, Acting Administrator Wheeler stated that the National PFAS Management Plan was undergoing interagency review and would be released shortly after the shutdown. He declined to promise that the management plan would recommend setting a drinking water standard, noting that he could not go into specifics about the plan because it was still under review. Acting Administrator Wheeler was also asked during his confirmation hearing about the status of EPA's TSCA Section 6(a) rule for methylene chloride in paint and coating removers. He responded that he had hoped to publish the rule in the Federal Register in early January 2019, but that the release of the rule had been delayed by the government shutdown. He then stated that he hoped that the rule would be ready once the government reopens.

EPA Releases Draft Risk Evaluation for Pigment Violet 29

On November 15, 2018, EPA released its draft risk evaluation for Pigment Violet 29, concluding that Pigment Violet 29 does not present an unreasonable risk to human health or the environment under the conditions of use evaluated.25 This risk evaluation is the first of ten draft risk evaluations that EPA must finalize by December 2019 (though the Agency may seek an extension to June 2020).26 EPA is expected to release the remainder of the risk evaluations in early 2019.

EPA's draft risk evaluation for Pigment Violet 29 provides interesting insight into how the Agency is developing risk evaluations for the first ten chemical substances.27 In particular, the draft makes clear that the Agency is willing to narrow the scope of a risk evaluation in response to comments it receives during the "scoping" and problem formulation stages.28 Additionally, EPA made clear in the draft risk evaluation for Pigment Violet 29 that, if a party does not believe that comments it submitted regarding the problem formulation statement for Pigment Violent 29 are adequately addressed by the draft risk evaluation, the party may resubmit its past comments to the docket for the draft risk evaluation and must do so if the party wishes the Agency to consider these comments further. Therefore, interested parties should keep an eye on the Federal Register for the release of additional draft risk evaluations of interest to them, and should be prepared to submit new comments or to resubmit prior comments to the extent that EPA has not adequately addressed the comments in the draft risk evaluation.

National PFAS Management Plan

EPA's Local Government Advisory Committee for Per- and Polyfluoroalkyl Substances (LGAC) submitted its report to EPA in November 2018.29 LGAC was formed in May 2018 to provide advice to EPA regarding the National PFAS Management Plan. LGAC recommended that EPA prioritize actions relating to PFAS to first "address communities and citizens at highest risk of PFAS contamination and potential harm," including "communities located near military sites, areas with historical or active large-scale fire-fighting operations (such as airports), [and] industrial sites or landfills where PFOS and PFOAs have a legacy of use and known releases."30 LGAC also recommends that EPA develop a maximum contaminant level (MCL) for PFOA and PFOS, and that EPA designate PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

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TSCA Regulatory Actions

EPA Releases First List of Unique Identifiers

On December 12, 2018, EPA published its first list of "unique identifiers" for substances for which EPA has approved a confidentiality claim for chemical identity.31 EPA is required under TSCA to publish annually a list of generic chemical substances and the unique identifiers associated with those substances.32

Pursuant to TSCA Section 14(g)(4),33 EPA was required to "develop a system to assign a unique identifier for each specific chemical identity" for which EPA approves a confidential business information (CBI) claim for chemical identity.34 The unique identifier is not permitted to be the "specific chemical identity" or a "structurally descriptive generic term."35 In May 2017, EPA proposed two systems to assign unique identifiers, but the Agency acknowledged that it was struggling to reconcile the statutory requirements that it apply the unique identifier to all non-confidential information about a chemical substance while also protecting the specific chemical identity of the substance.36 After receiving public comment on its two proposed systems, EPA proposed a third alternative in February 2018.37 EPA adopted the third alternative in June 2018.38

Under EPA's adopted unique identifier system, EPA will review a document it receives prior to applying the unique identifier to that document to determine if the document contains the specific chemical identity of a chemical substance. If it does, EPA will determine whether a CBI claim previously has been or is being asserted for the chemical identity of the substance to determine whether the claim is unexpired and/or is otherwise valid and should be granted. If the CBI claim for chemical identity is not expired and is otherwise valid, EPA will apply to that document the unique identifier assigned originally for the chemical substance. However, if no CBI claim for the chemical identity is being asserted by the submitter of a new document, EPA will not assign an existing Unique Identifier (UID) to the document in question if doing so would itself disclose to the public the confidential specific identity that the UID was assigned to protect. If the document contains no specific chemical identity information, or the CBI claim for the information has expired or is otherwise invalid, EPA will apply the unique identifier.

In the Agency's response to comments on its unique identifier system, EPA rejected an argument that the Agency must assign a UID to each chemical substance for which an identity CBI claim was made relating to the publication of the first TSCA Active-Inactive Inventory.39 However, EPA noted that the Agency believes it is required to assign UIDs to chemical substances for which a chemical identity CBI claim is re-substantiated or reasserted and substantiated. EPA indicated that it intends to promulgate a rule establishing how the Agency will review all claims to protect the identity of chemical substances on the confidential portion of the Inventory asserted pursuant to the claim maintenance provision of TSCA Section 8(b)(4)(B) and the TSCA Active-Inactive Inventory Rule. That rule is expected to be published in early 2019.40

EPA Publishes Draft Toxicity Assessments for GenX and PFBS

In mid-November 2018, EPA published draft toxicity assessments for two PFAS chemicals – hexafluoropropylene oxide (HPFO) dimer acid and its ammonium salt (GenX); and perfluorobutane sulfonic acid and related compound potassium perfluorobutane sulfonate (PFBS).41 EPA accepted comments on the draft toxicity assessments through January 22, 2019.42 EPA describes the draft toxicity assessments as providing "health effects information" for PFBS and GenX and as describing how the Agency considers health effects when developing draft toxicity values for these substances.43 EPA notes that these draft toxicity assessments are distinguishable from risk assessments in that toxicity assessments do not consider exposure. Upon finalization of the toxicity assessments, EPA suggests that the assessments may be used "along with specific exposure and other relevant information" to develop regulations for these chemical substances.44

Office of Management and Budget Reviewing Methylene Chloride Rules

The White House Office of Management and Budget is reviewing two rules relating to EPA's regulation of methylene chloride in paint and coating removers. On December 21, 2018, OMB began review of EPA's final TSCA Section 6(a) rule governing the use of methylene chloride in paint and coating removers. The final rule is expected to prohibit the consumer use of methylene chloride in paint and coating removers, and to restrict the commercial use of methylene chloride in paint and coating removers.

EPA published its proposed rule governing the use of methylene chloride and N-Methylpyrrolidone (NMP) in paint and coating removers in January 2017.45 EPA subsequently decided to include use as a paint and coating remover within the scope of the Agency's ongoing risk evaluation of NMP.46 Thus, the use of NMP in paint and coating removers would be addressed in a subsequent rulemaking, if undertaken.47 Additionally, although EPA intended to address the use of methylene chloride in commercial furniture refinishing in the same final rule as methylene chloride in paint and coating removers,48 EPA has decided to address commercial furniture refinishing in a separate rulemaking.49 EPA also is preparing to issue a "pre-rule" that would establish a "Commercial Paint and Coating Removal Training, Certification and Limited Access Program."50 This program is intended to provide a pathway for commercial users to continue to use methylene chloride-containing paint and coating removers.

PFAS Groundwater Cleanup Recommendations Likely to Reflect EPA Health Advisory

EPA's "draft interim recommendations" for the cleanup of PFAS in groundwater are likely to recommend a cleanup standard of 70 ppt—the same as EPA's current health advisory level for PFOA and PFOS in drinking water.51 The OMB has been reviewing the draft interim recommendations since August 2018, and the target date for the publication of these recommendations was initially September 2018.52 EPA has not provided an updated estimate of when these recommendations will be published.

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Legislative Developments

America's Drinking Water Infrastructure Act Becomes Law

On October 23, 2018, President Trump signed into law the America's Water Infrastructure Act, which expands requirements for the monitoring of unregulated contaminants.53 This legislation increases funding allocated for EPA's Drinking Water State Revolving Fund, which provides financial support to state drinking water systems.54 The legislation also requires drinking water systems serving more than 3,300 people to test for unregulated contaminants pursuant to EPA's Unregulated Contaminants Monitoring Rule.55Previously, only drinking water systems serving more than 10,000 people were required to monitor for unregulated contaminants.56 Past chemical substances covered by the Unregulated Contaminants Monitoring Rule include PFOA, PFOS, 1,2,3-trichloropropane, hexavalent chromium, and 1,4 dioxane.57 EPA has been asked to include PFAS chemicals again in the next iteration of the unregulated chemicals list.58 Monitoring requirements for chemicals on the next iteration of the unregulated chemicals list would likely take effect in 2022.59

Legislation Introduced to Designate PFAS Chemicals as Hazardous Substances Under CERCLA

A bipartisan group of members of the House of Representatives representing Michigan introduced legislation to designate PFAS chemicals as hazardous substances under CERCLA on January 14, 2019.60 The "PFAS Action Act of 2019" was introduced by Representatives Debbie Dingell, Fred Upton, and Dan Kildee. The legislation would require EPA to designate PFAS chemicals as hazardous substances under CERCLA within one year after enactment of the legislation. Designating these substances as hazardous would expand EPA's authority to respond to releases of PFAS chemicals.61 In testimony before House of Representatives and Senate subcommittees during the fall of 2018, then-EPA Director of the Office of Water Dr. Peter Grevatt testified that EPA was considering listing PFOA and PFOS as hazardous substances under CERCLA.62 EPA's website also indicates that the Agency "is beginning the necessary steps" to propose PFOA and PFOS as hazardous substances under CERCLA.63Notably, the PFAS Action Act of 2019 would require EPA to designate all PFAS chemicals (not just PFOA and PFOS) as hazardous substances under CERCLA.

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State Regulatory & Legislative Action

Alaska

Alaska's Department of Environmental Conservation (DEC) sought comment through November 13, 2018 on a proposal to set soil and groundwater cleanup standards for six PFAS chemicals. The DEC offered the proposal following the discovery of PFAS contamination in numerous areas across the state, primarily in areas near airports and Air Force bases.64 The proposal recommends the use of EPA's drinking water health advisory level for PFOA and PFOS—70 ppt—as the cleanup standard for PFOA, PFOS, PFNA, PFHxS, and PFHpA in soil and groundwater in Alaska.65 The proposal also would set a cleanup standard of 400 ppt for PFBS in soil and groundwater in Alaska.66 The DEC is currently reviewing comments received on the proposal during a public comment period.67

California

As of November 10, 2018, businesses that may expose persons (including workers and consumers) to PFOA or PFOS must provide "clear and reasonable warning[s]" about the potential health impacts of exposure to these substances.68 This requirement is a result of California's listing of PFOA and PFOS as developmental toxins under Proposition 65 in November 2017.69 Entities subject to this listing requirement include those that may expose persons to PFOA or PFOS through consumer products, occupational exposure, or environmental exposure.

Michigan

On December 28, 2018 then-Governor Rick Snyder signed Michigan Senate Bill 1244. Senate Bill 1244 generally requires the Michigan Department of Environmental Quality (MDEQ) to rely on toxicity values from EPA's Integrated Risk Information System (IRIS) in developing cleanup criteria for environmental remediation.70 If a toxicity value for a chemical substance is not available through IRIS, MDEQ must use toxicity values from the Agency for Toxic Substances and Disease Registry or EPAs provisional peer-reviewed toxicity values. If toxicity values are not available for a chemical substance through either of these means, MDEQ must use a toxicity value from EPA's Health Effects Assessment Summary Table, or toxicity values developed by other states, the European Union, Canada, or the World Health Organization to set cleanup criteria. If a toxicity value is still not available, MDEQ may develop its own toxicity values to support cleanup criteria.

If MDEQ wishes to develop its own toxicity values to support cleanup criteria despite the existence of IRIS toxicity values, it may do so only if (1) the IRIS value is based on a determination greater than 10 years old; (2) there is more recent peer-reviewed and widely accepted data; and (3) the weight of the evidence supports the use of the proposed toxicity value to support cleanup criteria. If all three of these criteria are met, MDEQ must provide public notice of its development of a toxicity value and provide for stakeholder engagement.

The sponsor of the legislation in the Michigan Senate, Senator Jim Stamas, stated that the bill is intended to move the process of updating cleanup criteria forward by resolving concerns from private industry about how these criteria are developed.71 However, environmental groups have argued that this bill would stifle DEQ's ability to set cleanup criteria based on the most recent science.72

New Hampshire

The New Hampshire Department of Environmental Services (NHDES) announced on January 2, 2019 new proposed groundwater and drinking water standards for perfluorinated substances.73Pursuant to July 2018 legislation, NHDES was required to initiate rulemakings to establish MCLs and ambient groundwater quality standards (AGQS) for PFOA, PFOS, PFNA, and PFHxS by January 1, 2019.74NHDES has proposed the following MCLs and AGQSs: (1) PFOA – 38 ppt; (2) PFOS – 70 ppt; (3) PFOA & PFOS (combined) – 70 ppt; (4) PFHxS – 85 ppt; (5) PFNA – 23 ppt. NHDES' proposed MCL for PFOA & PFOS is the same as EPA's drinking water health advisory level for these substances.75 NHDES also rejected a petition from environmental non-governmental organizations requesting that the Agency regulate PFAS compounds as a class.76

The July 2018 legislation also directs NHDES to develop a plan to establish surface water quality standards for PFOS, PFOA, PFNA, and PFHxS. The Department of Environmental Services is required to submit this plan to the New Hampshire legislature by January 1, 2020.77

New York

The New York State Drinking Water Quality Council (DWQC) has recommended that the state adopt MCLs for PFOA, PFOS, and 1,4 dioxane.78 On December 18, 2018, the DWQC recommended that the New York State Department of Health adopt MCLs of 10 parts per trillion for PFOA and PFOS, and 1 part per billion for 1,4 dioxane. The recommended MCLs for PFOA and PFOS would be the lowest in the country if adopted by the state's Department of Health. The MCL for 1,4 dioxane would be the first in the country. The Department of Health can either adopt the recommended MCLs and commence a rulemaking, or propose alternative MCLs.

The New York Department of Environmental Conservation announced in its Environmental Notice Bulletin that it is effectively delaying the compliance date for the state's Household Cleansing Product Information Disclosure Program from July 1, 2019 to October 2, 2019.79 Specifically, the department announced that it would not be enforcing the disclosure requirements of this program until October 2, 2019. The program was finalized in June 2018, and requires manufacturers of covered domestic and commercial cleaning products to post information about intentionally added ingredients (other than fragrances) and nonfunctional ingredients present above trace quantities on their websites.80 Manufacturers may assert confidentiality claims for trade secret or confidential commercial information. In general, manufacturers must include the following information about ingredients: Chemical Abstracts Service Registry Number and chemical name; percentage of content by weight; the ingredient's presence on lists of chemicals of concern; presence of nanoscale materials; and the ingredient's functional purpose.81

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*Camille Heyboer also contributed to this newsletter.

© Arnold & Porter Kaye Scholer LLP 2019 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. Contingency Plan for Shutdown, U.S. Envtl. Protection Agency (Jan. 14, 2019).

  2. 40 C.F.R. § 720.75.

  3. 40 C.F.R. § 720.38(d).

  4. 40 C.F.R. § 723.50(g).

  5. Fees for the Administration of the Toxic Substances Control Act, 83 Fed. Reg. 52,694, 52,719 (Oct. 17, 2018) (to be codified at 40 CFR § 700.45(h)).

  6. Certain Chemicals; Premanufacture Notices; Extension of Review Period, 61 Fed. Reg. 657 (Jan. 9, 1996); Extension of Review Periods Under the Toxic Substances Control Act; Certain Chemicals and Microorganisms; Premanufacture, Significant New Use, and Exemption Notices; Delay in Processing Due to Lack of Authorized Funding, 78 Fed. Reg. 64,210 (Oct. 28, 2013).

  7. 15 U.S.C. § 2604(c).

  8. 40 C.F.R. § 720.75(c).

  9. 78 Fed. Reg. 64,210.

  10. In re Aqueous Film-Forming Foams Products Liability Litigation, MDL No. 2873 (J.P.M.L. Dec. 7, 2018).

  11. Complaint for Declaratory & Injunctive Relief, Vt. Pub. Interest Grp. v. Wheeler, No. 2:19-cv-00009-jmc (D. Vt. Jan. 14, 2019).

  12. 15 U.S.C. § 2619.

  13. 15 U.S.C. § 2606.

  14. Safer Chemicals Healthy Families v. EPA, No. 17-72260 (Dec. 18, 2018).

  15. Respondents' Motion for Partial Voluntary Remand, Safer Chemicals Healthy Families v. EPA, No. 17-72260 (9th Cir. Aug. 6, 2018).

  16. Petitioners' Response to Respondents' Motion for Partial Voluntary Remand, Safer Chemicals Healthy Families v. EPA, No. 17-72260 (9th Cir. Sept. 17, 2018). For additional information, please see the October 2018 edition of The Chemical Compound.

  17. Organization Chart for EPA's Region 1 Office, U.S. Envtl. Protection Agency (last updated July 3, 2018).

  18. Hearing on the Nomination of Alexandra Dunn to be Assistant Administrator of the Environmental Protection Agency, Senate Comm. on Env't & Pub. Works (Nov. 29, 2018).

  19. Maria Hegstad, To Win Dunn's Confirmation, EPA Vows to Revise Key TSCA Programs, InsideEPA (Jan. 7, 2019).

  20. 15 U.S.C. § 2605(b)(4)(H).

  21. Gregory Wallace, Trump Announces Wheeler as EPA Nominee, CNN (Nov. 16, 2018).

  22. Brady Dennis & Juliet Eilperin, Scott Pruitt Steps Down as EPA Head After Ethics, Management Scandals, Wash. Post (July 5, 2018).

  23. Building the New EPA: One-on-One with Acting Administrator Wheeler, Wash. Post (Nov. 28, 2018),

  24. Id.

  25. Draft TSCA Risk Evaluation for Colour Index (C.I.) Pigment Violet 29; Notice of Availability (PV29); Notice of Availability, 83 Fed. Reg. 57,473 (Nov. 15, 2018).

  26. 15 U.S.C. § 2605(b)(4)(G).

  27. For additional information, please see Lawrence Culleen's November 2018 Advisory.

  28. U.S. Envtl. Protection Agency, DRAFT-EPA Document No. 740R18015, Draft Risk Evaluation for C.I. Pigment Violet 29 (Anthra{2,1,9-def:6,5,10-d'e'f'}diisoquinoline- 1,3,8,10(2H,9H)-tetrone) (2018).

  29. U.S. Envtl. Protection Agency Local Gov't Advisory Comm., EPA's Local Government Advisory Committee – Per- and Polyfluoroakyl Substances (PFAS) Report (2018).

  30. Letter from Robert A. Dixson, Chair, Local Gov't Advisory Comm., et al., to Andrew Wheeler, Acting Administrator, U.S. Envtl. Protection Agency (Nov. 19, 2018).

  31. EPA Review and Determination of CBI Claims Under TSCA, U.S. Envtl. Protection Agency (last updated Dec. 12, 2018).

  32. 15 U.S.C. § 2613(g)(4)(B).

  33. 15 U.S.C. § 2613(g)(4).

  34. Id.

  35. Id.

  36. Assignment and Application of the "Unique Identifier" Under TSCA Section 14; Notice of Public Meeting and Opportunity to Comment, 82 Fed. Reg. 21,386 (May 8, 2017).

  37. Assignment and Application of the "Unique Identifier" Under TSCA Section 14; Notice of Additional Information and Opportunity to Comment, 83 Fed. Reg. 5,623 (Feb. 8, 2018).

  38. TSCA Chemical Substances; Unique Identifier Assignment and Application Policy; Notice of Availability, 83 Fed. Reg. 30,168 (June 27, 2018).

  39. Response to Comments on Unique Identifier Assignment and Application, U.S. Envtl. Protection Agency (June 27, 2018).

  40. Procedural Rule: Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory – Amended TSCA Section 8(b)(4)(c), Office of Information & Regulatory Affairs (Fall 2018).

  41. U.S. Envtl. Protection Agency, EPA-823-P-18-001, Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3) (Nov. 2018); U.S. Envtl. Protection Agency, Human Health Toxicity Values for Perfluorobutane Sulfanic Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3) (Nov. 2018).

  42. Request for Public Review and Comment: Draft Human Health Toxicity Assesments for Hexafluoropropylene Oxide Dimer Acid and its Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane Sulfonate, 83 Fed. Reg. 58,768 (Nov. 21, 2018).

  43. Id.

  44. Id.

  45. Methylene and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a), 82 Fed. Reg. 7,464 (Jan. 19, 2017).

  46. Methylene Chloride; Rulemaking Under TSCA Section 6(a), Office of Information & Regulatory Affairs (Fall 2018).

  47. Id.

  48. 82 Fed. Reg. at 7,465.

  49. Office of Information & Regulatory Affairs, supra note 45.

  50. Kelly Franklin, U.S. EPA Moves to Finalise Methylene Chloride Paint Stripper Rule, ChemicalWatch (Jan. 8, 2019).

  51. Kelsey Tamborrino, Inside EPA's Chemical Clean-Up Plan, POLITICO (Jan. 8, 2019).

  52. EPA Actions to Address PFAS, U.S. Envtl. Protection Agency (last updated May 14, 2018).

  53. America's Water Infrastructure Act, Pub. L. No. 115-270 (2018).

  54. Id.; see also Drinking Water State Revolving Fund, U.S. Envtl. Protection Agency, (last updated Sept. 13, 2018).

  55. America's Water Infrastructure Act; see also Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems and Announcement of Public Meeting, 71 Fed. Reg. 92,666 (Dec. 20, 2016).

  56. Reporting Requirements for the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4), U.S. Envtl. Protection Agency (last updated Nov. 16, 2017).

  57. The Third Unregulated Contaminant Monitoring Rule (UCMR 3): Data Summary, January 2017, U.S. Envtl. Protection Agency (Jan. 2017).

  58. See, e.g., Association of State Drinking Water Administrators, Comments Regarding PFAS National Leadership Summit and Engagement 2 (July 20, 2018).

  59. Id

  60. PFAS Action Act of 2019, H.R. 535, 116th Cong.

  61. 42 U.S.C. § 9604.

  62. For additional information, please see the October 2018 edition of The Chemical Compound.

  63. PFAS Laws and Regulations, U.S. Envtl. Protection Agency (last updated July 30, 2018).

  64. Tim Ellis, State Proposes Groundwater-Contamination Cleanup Levels for PFAS-Related Substances (Oct. 11, 2018).

  65. Press Release, Alaska Dep't of Envtl. Conservation, DEC Takes Action on PFAS Contamination: Seeks Public Comment on Proposed Cleanup Levels for Fire-Fighting Chemicals in Drinking Water (Oct. 4, 2018).

  66. Id.

  67. Cleanup Level Amendments, Alaska Dep't of Envtl. Conservation (last visited Dec. 3, 2018).

  68. 27 CCR § 25601.

  69. For additional information, please see the January 2018 edition of The Chemical Compound.

  70. Natural Resources and Environmental Protection Act, S.B. 1244 (2018). For pesticides, MDEQ may rely on the EPA Office of Pesticide Programs' toxicity values for pesticides instead of IRIS values.

  71. Garrett Ellison, Bill Would Limit Science Michigan Uses to Regulate Toxic Cleanups, MLIVE (Dec. 3, 2018).

  72. Id.

  73. Press Release, New Hampshire Dep't of Envtl. Svcs., NHDES Proposes New PFAS Drinking Water Standards, Initiates Rulemaking for PFOA, PFOS, PFHxS, PFNA (Jan. 2, 2019),.

  74. SB 309-FN (N.H. 2018).

  75. Drinking Water Health Advisory for Perfluorooctanoic Acid (PFOA), U.S. Envtl. Protection Agency (May 2016); Drinking Water Health Advisory for Perfluorooctane Sulfonate (PFOS), U.S. Envtl. Protection Agency (May 2016).

  76. Jeff McMenemy, State Declines to Adopt Stricter PFAS Regulations, Seacost Online (Jan. 11, 2019).

  77. SB 309-FN (N.H. 2018).

  78. Press Release, N.Y. State Dep't of Health, Drinking Water Quality Council Recommends Nation's Most Protective Maximum Contaminant Levels for Three Unregulated Contaminants in Drinking Water (Dec. 18, 2018).

  79. Environmental Notice Bulletin (ENB) – Statewide Notices, N.Y. Dep't of Envtl. Conservation (Jan. 9, 2019).

  80. N.Y. State Dep't of Envtl. Conservation, Household Cleansing Product Information Disclosure Program Certification Form and DMM-2, DEC Program Policy on Household Cleansing Product Information Disclosure Program (June 6, 2018).

  81. For more information, please see our June 2018 edition of The Chemical Compound.

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