EPA Announces Order for PFAS Testing – Response to Petition from Public Health and Environmental Justice NGOs

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On December 28, 2021, EPA announced that the Agency was granting a petition from several North Carolina public health and environmental justice organizations to require companies to conduct health and toxicity testing of certain PFAS.  In its announcement, EPA explained that the petitioners’ request “plays a key role in advancing the Agency’s plans for a National PFAS Testing Strategy.”

The National PFAS Testing Strategy requires PFAS manufacturers to provide EPA with toxicity data and other information on categories of PFAS.  This approach breaks the thousands of PFAS into categories based on characteristics and assesses what data are presently available for each category.  The test data will eventually be used to inform regulatory efforts to protect human health and the environment.

The petition asking the Agency to require testing on the health and environmental impacts of 54 PFAS was first submitted in October 2020.  The petition was submitted by the Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.   The petition identified the 54 substances at issue as PFAS manufactured by the Chemours Company.   In January 2021, the previous Administration denied the petition.  In March 2021, the petitioners asked EPA to reconsider its denial.  In September 2021, EPA agreed to do so “in light of the change in administration and in policy priorities concerning PFAS.”

In granting the petition, EPA is requiring testing under the National PFAS Testing Strategy.  EPA’s first test orders under the Testing Strategy, for 24 categories of PFAS, will provide human health hazard data that covers 30 of the 54 petition chemicals.  Nine of the PFAS identified in the petition belong to a single category included in the Testing Strategy.  EPA is assessing if the existing data is sufficient and will likely order testing in the future.  EPA explained that the 15 remaining petition chemicals do not fit the definition of PFAS used in developing the Testing Strategy.  However, the Agency will analyze available data on these substances to inform later phases of testing.

In response to the petition, EPA also announced that the Agency is taking part in and analyzing many ongoing human studies on PFAS.  This includes evaluations of potentially exposed workers and communities in North Carolina.

The petition requested the development or submission of analytical standards with the test orders.  In response, EPA is requesting comment on whether to require the submission of existing analytical methods for PFAS.  This would occur through a future PFAS rulemaking.

The Agency’s press release on the petition quotes Administrator Michael S. Regan: “By taking action on this petition, EPA will have a better understanding of the risks from PFAS pollution so we can do more to protect people.”

New Jersey PFAS Litigation Against 3M, DuPont, and Others to Continue

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New Jersey litigation against Dupont, Chemours, Corteva, and 3M over PFAS contamination will proceed following a federal district court ruling on a 3M motion to dismiss in December 2021.  The case involves contamination of four different sites in New Jersey, two of which were at issue in the motion to dismiss — 3M is not a defendant in the litigation over the other two sites.  Claims against 3M were brought under New Jersey’s Spill Compensation and Control Act (the “Spill Act”) and under New Jersey common law.

Spill Act

In its assessment, the Court explained that the Spill Act provides that generally “any person who has discharged a hazardous substance, or is in any way responsible for any hazardous substance, shall be strictly liable, jointly and severally, without regard to fault, for all cleanup and removal costs no matter by whom incurred.” It went on to say that although the Spill Act does not define the phrase “in any way responsible for any hazardous substance,” that the Act, does, however, instruct that it is to “be liberally construed to effect its purposes.” The Court further found that another court in this district had considered a motion by 3M to dismiss another Spill Act claim in Giordano v. Solvay Specialty Polymers USA, LLC, and had found that the plaintiffs in that case had sufficiently alleged that 3M was “in any way responsible for the contaminated water supply.”  It then held that Giordano was persuasive and found that the State had sufficiently “pled that 3M is ‘in any way responsible for’ the discharge of hazardous substances at both of the Sites at issue.”

Failure to Warn

New Jersey also argued that 3M owed a duty to warn the State that 3M’s PFAS-containing products could endanger New Jersey’s citizens and environment.  The State asserted that this duty arose under common law from its role as parens patriae, which is the State’s authority to act for citizens who cannot protect or advance their own interests, and the duty as trustee of New Jersey’s environment and natural resources.

The Court explained that to determine whether a duty exists at common law, the New Jersey Supreme Court first asks whether it was foreseeable that a party’s conduct was capable of harming another.  And then, where foreseeability has been established, the New Jersey Supreme Court assesses “the relationship of the parties, the nature of the attendant risk, the opportunity and ability to exercise care, and the public interest in the proposed solution

To assess foreseeability, the court, assessed whether it was foreseeable to 3M that its products could harm the State of New Jersey’s citizens and natural resources.  Analyzing the question in the context of a motion to dismiss, the Court presumed that New Jersey’s allegations and all reasonable inferences therefrom were true and found that the State has adequately established foreseeability of the harm.  The court then found that 3M did owe a duty to the state, explaining that “the Court again notes that the New Jersey Supreme Court has instructed that whether a duty exists ‘devolves to a question of foreseeability of the risk of harm to that individual or identifiable class of individuals.’  The New Jersey Supreme Court did not limit its inquiry to those with whom a defendant had a relationship.” And that, “New Jersey courts have not limited the duty to warn to those with whom a defendant has a direct relationship.”  Furthermore, the Court found that the public interest also favors finding of a duty as the prevention of far-reaching environmental and human harm is of paramount public concern.  The Court then held that the State had plausibly alleged a failure to warn and denied 3M’s motion to dismiss.

Design Defect

Finally, the Court found that New Jersey had adequately stated a claim for design defect claim.  The Court explained that “to state a claim for design defect under New Jersey law, a plaintiff must plead either that the product’s risk outweighs its harm, or that an alternate design exists.”  Because the State had alleged that “PFOA and PFOS have characteristics that cause extensive and persistent environmental contamination,” that “PFOA and PFOS contamination presents a serious threat to public health through drinking water,”  that PFAS exposure “has been linked to several diseases, including kidney and testicular cancer, thyroid disease, ulcerative colitis, high cholesterol, and pregnancy-induced hypertension and low birth weight,” that the PFAS used at the sites “were defective in design and unreasonably dangerous” for similar reasons, and that “the foreseeable risk to public health and welfare posed by 3M’s PFAS outweighed the cost to 3M of reducing or eliminating such risk,” the Court held that New Jersey had “managed to plead enough facts to eke out a claim for a design defect.”

US District Court Judge John Michael Vazquez issued the unpublished opinion.

OIG to Audit EPA New Chemicals Review

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EPA’s Office of Inspector General (OIG) has informed the Office of Chemical Safety and Pollution Prevention (OCSPP) that it will audit EPA’s process for conducting reviews of new TSCA chemicals (i.e., substances submitted to the Premanufacture Notification (PMN) and PMN exemption processes).  This is a self-initiated audit to accomplish OIG’s oversight plan for fiscal year 2022, to address ensuring safe use of chemicals, and to address complaints from the OIG Hotline.  OIG seeks to determine the extent EPA is following records-management requirements, quality-assurance requirements, and employee performance standards.  OIG will also be looking at how EPA manages human health and environmental risks for approving new chemicals under TSCA.

OIG has asked OCSPP to assist in expediting the audit by providing all materials, handbooks, and anything related to the review of new chemicals; the resource allocations for chemical review from fiscal years 2018 through 2021; scopes of work for any contracts related to chemical review; any guidance they have received on chemical review; and new chemicals review program organization charts before and after the October 2020 reorganization.

OIG notes authority under the Inspector General Act of 1078, as amended, to have timely access to their requests and personnel.  In addition to the Inspector General Act, in its request, OIG references EPA Manual 6500 and statements from Administrator Michael S. Regan.

EPA Announces Improvements to the TSCA Risk Evaluation Process  

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On December 20, 2021, EPA released a draft TSCA Systematic Review Protocol. In its announcement on the new Protocol, the Agency explained that the Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA Risk Evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment.  The draft protocol comprises nearly 700 pages.

The draft Protocol notes that EPA’s Office of Pollution Prevention and Toxics (OPPT) applies systematic review principles in the development of its Risk Evaluations of existing chemicals.  It provides specific systematic review approaches which they use for identifying and evaluating evidence for the hazard and exposure assessments that support Risk Evaluations. OPPT added that the draft Protocol responds to key recommendations received from the National Academies of Sciences, Engineering, and Medicine (NASEM).

The Protocol was developed in response to NASEM’s critique that EPA had not previously documented how TSCA prioritization and problem formulation relate to the TSCA Systematic Review.  The Protocol aligns the TSCA prioritization and scoping processes with the steps of the Protocol.  In addition, the Protocol defines how EPA’s systematic review efforts will identify data gaps and data needs in the Risk Evaluations process.  OPPT explains that identifying these data gaps and data needs will provide the Agency with the information it needs “to strategically exercise TSCA authorities to require testing or information collection for use in TSCA prioritization and Risk Evaluation.”

The Protocol reports that for the 20 high-priority substances currently undergoing Risk Evaluation and substances undergoing manufacturer-requested Risk Evaluation, EPA has implemented a new, unified literature search process.  This process, as described in the Protocol, uses chemical identifiers to maximize the capture of relevant literature, which in turn provides consistency and efficiency to the literature search.  In addition, OPPT announced that the Protocol includes new methods to reduce bias and improve evaluation through the use of calibration exercises and data evaluation training for reviewers.  This is a response to NASEM recommendations, SACC comments, and public comments.

In addition, the Protocol includes a description of the evidence integration process.  A step that was not part of the 2018 TSCA systemic review document. This addition was also made in response to recommendations by the NASEM and the SACC. OPPT explains that the Protocol’s evidence integration approach relies on methods related to those in EPA’s IRIS Handbook.

The draft protocol will undergo peer review by at a meeting of the SACC on April 19-21, 2022.  OPPT noted that the agency will use this feedback to further improve the document. The date, time for the public peer review virtual meeting will be announced on the SACC website.

IRS Publishes List of Chemicals Subject to Superfund Tax

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The Infrastructure Investment and Jobs Act (IIJA), Public Law 117-58, 135 Stat. 429 (November 15, 2021) reinstated the excise taxes imposed on certain chemical substances to help clean up hazardous waste sites (“the Superfund tax”).

Section 80201 of the IIJA identified more than 40 chemicals subject to the tax and the rates at which those substances will be taxed, including benzene, methane, xylene, toluene, and phosphorus.

Section 80201 also directed the IRS to publish an initial list of taxable substances under section 4672(a) of the Internal Revenue Code by January 1, 2022.  The initial list was published on December 13, 2021.   It comprises 101 chemical substances, including bisphenol-A, butyl benzyl phthalate, glycerine, pentaerythritol, perchloroethylene, tetrahydrofuran, and trichloroethylene.  The section also states the tax will last until December 31, 2031.

The IRS will publish guidance on the procedures by which importers or exporters may request a determination that the list of taxable substances be modified by either adding or removing a substance.

Limited exceptions are provided for chemicals that are part of an intermediate hydrocarbon stream and to the sale of any intermediate hydrocarbon streams.  Registration under section 4662(c)(2)(B) is required to qualify for these exceptions.

IIJA requires full implementation of the tax by July 1, 2022.

Ending Inventory Correction for Substances Listed to the Initial TSCA Inventory

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On February 24, 2022, EPA announced that is revoking the process for correcting the substance identities of substances that were incorrectly described when they were listed on the initial TSCA Inventory in 1978.  Guidelines for Inventory correction were published in 1980 when the Agency recognized that a number of the substances reported to the initial Inventory had been unintentionally, incorrectly described.  Starting on April 26, 2022, companies will be required to submit a premanufacture notice (PMN) in order to request a change to the chemical identity of a substance listed on the Inventory.  Until that time, EPA will continue to accept correction requests that meet the 1980 guidelines.

In its announcement, EPA noted that the 1980 guidelines did not identify a time period during which corrections to the Inventory could be submitted.  However, EPA stated they never intended for the correction period to be indefinite, noting that companies have had more than 40 years since the 1980 publication of the revised TSCA Inventory to make corrections.

EPA stated they will continue to initiate Inventory corrections for substances that it determines were unintentionally misidentified.  For those cases, EPA may request information from a company to support an Inventory correction in lieu of requiring a PMN.  The announcement noted that the revocation will not affect regular maintenance of the Inventory which does include updates to substance identity nomenclature.

Update on Roundup Appeal to the U.S. Supreme Court

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Roundup has been the subject of countless lawsuits.  One critical case is Monsanto v. Hardeman, 21-241.  Bayer has petitioned the U.S. Supreme Court for relief.  Recent Court action suggests that the Supreme Court might hear the case.  In December the U.S. Supreme Court solicited the Biden administration’s opinion on whether to hear Bayer AG’s appeal of a $25 million award to Edwin Hardeman.  Hardeman asserts that decades of exposure to Roundup caused his non-Hodgkin’s lymphoma.

Bayer contends that the Ninth Circuit wrongly affirmed the district court’s decision.  The company argues that the Ninth Circuit wrongly decided that FIFRA did not preempt Hardeman’s state-law failure-to-warn claim, despite EPA’s conclusion that such a cancer warning would be false and therefore prohibited by FIFRA.  The company asserts that ruling contravenes the Supreme Court’s holding that any state labeling requirement not “genuinely equivalent” to a FIFRA labeling requirement is preempted. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005).

Bayer further argues that the Ninth Circuit wrongly affirmed the admission of expert opinions that glyphosate can cause non-Hodgkin’s lymphoma and caused Hardeman’s cancer specifically, even though those opinions rested on “little more than subjective intuitions” in conflict with Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), which requires trial courts to play “a gatekeeping role” to ensure that expert opinions are reliable, and with Federal Rule of Evidence 702, which requires expert opinions to be the product of “reliable principles and methods,” “reliably applied … to the facts of the case,” Fed. R. Evid. 702(c)-(d).

The following groups have filed amici briefs in the case: CropLife America, U.S. Chamber of Commerce, Atlantic Legal Foundation, Lawyers for Civil Justice, Product Liability Advisory Council, Inc., Retail Litigation Center, Inc., and Washington Legal Foundation. In response to the Supreme Court announcement, Bayer released a statement declaring that “[n]ow that the Supreme Court has requested input from the Solicitor General in this case, we will not entertain any further settlement discussions with plaintiff lawyers that are representing a substantial number of Roundup claims.”

It is expected that, before the current Court term ends in late June, the justices will probably say whether or not they will hear the case.

EPA Proposes Addition of 12 Chemicals to Toxic Chemical List

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EPA is proposing to add 12 chemicals to the list of toxic chemicals which are subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA), section 313.  Under EPCRA section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA issued a statement of policy in the Federal Register of February 4, 1987 (52 FR 3479) (FRL-3101-6) providing guidance regarding the recommended content of and format for petitions.  Additionally, EPA believes one chemical should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical.  The Toxics Use Reduction Institute filed a petition for EPA to consider 25 chemicals for inclusion the toxic chemicals list. EPA reduced the list to 12 because the other chemicals did not meet the statutory criteria listed below.

The chemicals substance identities and CASRNs are:

  • 1-Bromopropane; 106-94-5
  • Dibutyltin dichloride; 683-18-1
  • 1,3-Dichloro-2-propanol; 96-23-1
  • Formamide; 75-12-7
  • 1,2,5,6,9,10-Hexabromocyclododecane; 3194-55-6
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB); 1222-05-5 (PBT chemical identified by EPA)
  • N-Hydroxyethylethylenediamine; 111-41-1
  • Methylhexahydrophthalic anhydride; 25550-51-0
  • Nitrilotriacetic acid trisodium salt; 5064-31-3
  • Nonylphenol; 25154-52-3
  • p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9
  • 1,2,3-Trichlorobenzene; 87-61-6
  • Triglycidyl isocyanurate; 2451-62-9
  • Tris(2-chloroethyl) phosphate; 115-96-8
  • Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8
  • Tris(dimethylphenol) phosphate; 25155-23-1

EPCRA section 313 allows for the addition of chemicals if they meet one of three different requirements: acute human health effects criterion, chronic human health effects criterion, and environmental effects criterion.   Substances can be added to the section 313 list if:

  • The chemical can reasonably be anticipated to cause significant health issues in humans, existing beyond the facility site, as a result of continued releases.
  • The chemical can reasonable be anticipated to cause cancer, reproductive issues, neurological disorders, heritable genetic mutations, or other chronic health effects in humans.
  • The chemical can reasonably be anticipated to cause a significant adverse effect on the environment to due to its toxicity that it warrants reporting under this section in the judgment of the Administrator.

EPA believes these 12 chemicals in moderately low to low doses/concentrations each meet at least one of the criteria. EPA is proposing a 100-pound reporting threshold for HHCB because it has been shown to be bioaccumulative in aquatic species with bioconcentration factor values greater than 1,000.  The threshold for reporting non-PBT, toxic chemicals is 10,000 pounds of the chemical used at a facility per year.

White House Plan to Combat PFAS

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The White House announced a multi-agency plan to address the risks posed by PFAS.  The plan involves eight federal agencies including the Departments of Agriculture, Defense, Agriculture, Homeland Security, and Health and Human Services (HHS).   The White House explained that “To safeguard public health and protect the environment, the efforts being announced will help prevent PFAS from being released into the air, drinking systems, and food supply, and the actions will expand cleanup efforts to remediate the impacts of these harmful pollutants.”

A key element in this plan is EPA’s PFAS Roadmap, which addresses PFAS through a number of environmental statutes from TSCA to the Safe Drinking Water Act.

The White House Council on Environmental Quality (CEQ) Chair Brenda Mallory will lead the newly-formed Interagency Policy Committee on PFAS. The committee on PFAS will work to coordinate and help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country.

The White House Fact Sheet also identified efforts underway at the DOD, FDA, and other HHS agencies.

DOD is conducting PFAS cleanup assessments at the nearly 700 DOD installations and National Guard locations where PFAS were used or may have been released.  The Department expects to complete its initial assessments by the end of 2023.  In addition, DOD manages a large research and development program on PFAS detection, treatment, and destruction—with $70 million devoted to a PFAS-free replacement firefighting foam.

The FDA will expand its testing of the food supply to advance efforts to estimate dietary exposure to PFAS from food.  In addition, FDA will report on the process of phasing out sales of certain PFAS from food contact uses, following the 3-year phase out agreements reached with certain manufacturers in 2020.  Outreach efforts are also underway to ensure that companies are reminded of packaging requirements that are intended to reduce human exposure to PFAS.  The FDA will also monitor the presence of and potential exposure to PFAS in cosmetics.

HHS will review the research on human health and PFAS.  This includes a study by two HHS agencies, Centers for Disease Prevention and Control (CDC) and Agency for Toxic Substances and Disease Registry (ATSDR), in eight states that will provide information about the health effects of PFAS exposure.

EPA PFAS Strategic Roadmap

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EPA has compiled a roadmap outlining Key Actions to address the risks posed by PFAS.  The roadmap identifies key actions under TSCA and other statutes including the Clean Water Act, the Safe Drinking Water Act, and Superfund.

TSCA

The roadmap calls for EPA to “close the door” on abandoned PFAS; i.e., PFAS chemicals that are no longer produced.  Many of these substances have no restrictions under TSCA.  This leaves the door open for manufacturers to start producing the chemicals again.  The roadmap intends for EPA to designate all uses of these substances that are not current uses as Significant New Uses.  This will allow EPA to review and make determinations on the potential risks, and require safety measures, before allowing the manufacturing of those chemicals again.   The roadmap states that EPA plans to implement this action item during the summer of 2022.

There is an ongoing goal of completing toxicity assessments for two PFAS known as GenX chemicals.  EPA also has a goal to publish health advisories for GenX chemicals and PFBS in Spring 2022.

Other actions under TSCA include

  • Publish national PFAS testing strategy,
  • Review previous decisions on PFAS, and
  • Finalize new PFAS reporting under TSCA Section 8.

TRI

Another key action in the roadmap is for EPA to categorize PFAS on the Toxic Release Inventory (TRI) as “Chemicals of Special Concern” and to remove the de minimis eligibility from supplier notification requirements for all Chemicals of Special Concern.  Adding PFAS to TRI has a projected completion goal of 2022.

CWA

The roadmap calls for restricting PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines (ELG) program.  EPA plans to undertake rulemaking to restrict PFAS discharges from organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating operations.  A proposed rule for plastics and synthetic fibers is expected in Summer 2023, and a rule for metal finishing and electroplating is expected in Summer 2024.  Other industries EPA is considering issuing PFAS ELGs for include electrical and electronic components, textile mills, and landfills.

SDWA

EPA has goal to establish a national primary drinking water regulation for PFOA and PFOS.  EPA regulates drinking water for over 90 contaminants but that does not include any for PFAS.  EPA expects to issue a proposed regulation in Fall 2022.  The agency has a statutory deadline of March 2023 to complete this action.

Superfund

EPA is developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances.  This would require facilities to report on PFOA and PFOS releases that meet or exceed set reportable quantities.  The proposed rulemaking will be available for public comment in Spring 2022.   EPA is also asking for public comment on designating additional PFAS as hazardous substances under CERCLA.

CAA

The Clean Air Act requires EPA to regulate emissions of hazardous air pollutants, which do not currently include PFAS.  EPA plans to identify sources of PFAS air emissions, concentration levels, and cost-effective mitigation technologies.