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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on December 28, 2021, it is granting a petition from six North Carolina public health and environmental justice organizations filed under Section 21 of the Toxic Substances Control Act (TSCA) to compel companies to conduct testing of certain per- and polyfluoroalkyl substances (PFAS). The previous Administration denied the petition on January 22, 2021. 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company to fund and carry out this testing under the direction of a panel of independent scientists. The petitioners requested that EPA reconsider its denial in March 2021, which EPA agreed to do in September 2021, in light of the change in Administration and attendant change in policy priorities concerning PFAS. As reported in our October 19, 2021, memorandum, EPA published a National PFAS Testing Strategy (Testing Strategy) that identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data. EPA states that these substances include many of the chemicals identified in the petition, as well as additional PFAS that will inform a wider universe of categories of PFAS where key data are lacking. For example, according to EPA, the first phase of testing on 24 PFAS is expected to provide data that can be extrapolated to 2,950 PFAS that belong to the same categories as the 24 individual substances.

EPA states that it has granted the petition and will use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the following studies that will provide toxicity data and information on categories of PFAS:

  • Near-Term Testing Covers 30 of 54 Petition Chemicals -- Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals;
  • Subsequent Testing May Cover Nine of 54 Petition Chemicals -- An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing;
  • Remaining 15 of 54 Petition Chemicals -- According to EPA, 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there are robust data on some of them available to it. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing;
  • Mixtures Studies -- EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS;
  • Human Studies -- EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to advance and expand on these efforts further. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina; and
  • Analytical Standards -- EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to issue in final next year.

Commentary

EPA’s reversal is hardly surprising. The Biden Administration’s commitment to obtaining information on PFAS is clear and has been reinforced in many contexts. In her remarks before the Committee on Energy and Commerce on October 27, 2021, for example, Assistant Administrator Freedhoff stated that EPA is “scouring all sources of information to identify important gaps in existing data and to select representative chemicals within identified categories or additional testing.” Reconsidering the prior Administration’s denial of the Section 21 petition seems like a no-brainer.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 17, 2021, the U.S. Environmental Protection Agency announced the availability of its response to an August 16, 2021, petition filed under Section 21 of the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 64129. William D. Bush requested that EPA determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment,” and issue a rule or order under TSCA to “eliminate the hazardous chemicals used in mixtures [in cosmetics].” EPA states that after “careful consideration,” it has denied the petition. EPA notes that TSCA Section 3(2)(B) excludes “cosmetic” from the definition of “chemical substance” when manufactured, processed, or distributed in commerce for use as a cosmetic. Cosmetics, and any combination of chemicals contained therein, are thus not chemical substances under TSCA when manufactured, processed, or distributed in commerce for use as a cosmetic. EPA states that to the extent the petition seeks a TSCA Section 6 action on “cosmetics” when manufactured, processed, or distributed in commerce as cosmetics, the requested actions are not within its jurisdiction under TSCA. In addition, according to EPA, to the extent the petition seeks action on “chemical substances” within the TSCA Section 3(2) definition of that term, EPA finds that the petition did not set forth facts establishing that it is necessary for EPA to initiate an appropriate proceeding pursuant to TSCA Section 21. In particular, according to EPA, the petition did not identify the disposal of any particular chemical substance(s) or mixture(s) that could support a determination of unreasonable risk to the environment and, therefore, did not set forth sufficient facts establishing that it is necessary to issue a TSCA Section 6(a) rule addressing cosmetic disposal.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2021, the U.S. Environmental Protection Agency (EPA) announced its response to a petition submitted under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. 86 Fed. Reg. 59931. EPA states that TSCA Section 6(a) authorizes it to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If EPA determines that there is unreasonable risk to health or the environment, then EPA must, by rule, issue regulations to the extent necessary so that the chemical substance no longer presents such risk. EPA notes that TSCA Section 3(2)(B), which defines “chemical substance,” excludes “tobacco or any tobacco product,” however. Under Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” EPA states that it finds that the petitioner has not met its burden as defined in TSCA Sections 6(a) and 21(b)(1) “because cigarettes are not a product that can be regulated under TSCA section 6(a).”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 2, 2021, the U.S. Environmental Protection Agency (EPA) received a petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. Filed by William David Bush, the petition states that the more than 4,000 chemicals in cigarette smoke come from chemicals within the soil, the paper surrounding the tobacco column, and the manufacturing process, while others are deliberately added. According to the petition, cigarette butts endanger the health of the environment, comprising 30-40 percent of items collected in annual coastal/urban cleanups. Organic compounds “seep from cigarette butts into aquatic ecosystems, becoming acutely toxic to fish and microorganisms.” The petitioner asks EPA to:

  • Determine that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment;
  • Order by rule that cigarette manufacturers eliminate the hazardous chemicals used in a mixture with tobacco, including but not limited to the toxic substance inclusions resulting from tobacco growing or handling techniques;
  • Order by rule that cigarette manufacturers develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment.

EPA acknowledged receipt of Bush’s petition on September 9, 2021, stating that it will grant or deny the petition by October 31, 2021.
 
EPA received a second TSCA Section 21 petition from Bush on August 16, 2021, seeking a determination that the chemical mixtures contained within cosmetics present an unreasonable risk of injury to public health and the environment. According to the petition, since 2009, almost 600 cosmetics manufacturers have reported using 88 chemicals in more than 73,000 products that have been linked to cancer, birth defects, or reproductive harm. The petition states that these toxic chemicals have been banned by the European Union (EU) “and many other nations.” The petition notes that Congress has not given the Food and Drug Administration (FDA) the authority to regulate the chronic risks posed by chemicals and contaminants in cosmetics and that FDA does not have the power to suspend registration or order recalls when products pose a risk of serious adverse health consequences or death. The petition asks that EPA order by rule that cosmetic manufacturers eliminate hazardous chemicals used in mixtures, stating that examples include formaldehyde, paraformaldehyde, methylene glycol, quaternium 15, mercury, dibutyl and diethylhexyl phthalates, isobutyl and isopropyl parabens, long-chain per- and polyfluoroalkyl substances (PFAS), and m- and o-phenylenediamine.

EPA acknowledged receipt of Bush’s second petition on September 20, 2021, stating that it will grant or deny the petition by November 14, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition for the following reasons:

  • Request for prioritization under TSCA Section 6 and related testing under TSCA Section 4(a)(2)(B): Because TSCA Section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for phosphogypsum and process wastewater, EPA is treating this portion of the request as a petition for action under the APA. Petitioners assert that “should EPA initiate prioritization but find that the development of new information is necessary to finalize a prioritization decision for phosphogypsum and process wastewater, EPA should exercise its authority under section 4(a)(2)(B) to obtain that information and establish priority.” EPA states that because it is not addressing the request for prioritization and has not otherwise initiated prioritization on phosphogypsum or process wastewater, it is not in a position to exercise its authority under TSCA Section 4(a)(2)(B) in the manner and for the reason described by petitioners.
  • Request for significant new use rule (SNUR) under TSCA Section 5: TSCA Section 21 does not provide for the submission of a petition seeking the initiation of a rule under TSCA Section 5. EPA states that SNURs are issued under the authority of TSCA Section 5(a)(2). Since TSCA Section 21 does not provide an avenue for petitioners to request the initiation of a proceeding to make a determination by rule under TSCA Section 5(a), EPA is treating this portion of the request as a petition for action under the APA.
  • Request for issuance of a test rule under TSCA Section 4(a)(1)(A): According to the notice, TSCA Section 21 does provide for the submission of a petition seeking issuance of a test rule under TSCA Section 4(a)(1)(A). EPA states that it finds that the petitioners have not met their burden as defined in TSCA Sections 4(a)(1)(A) and 21(b)(1) because the petitioners have not provided the facts necessary to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.

More information about the petition is available in our March 12, 2021, memorandum, “EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 22, 2021, the U.S. Environmental Protection Agency (EPA) published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS).  86 Fed. Reg. 6602.  The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) to fund and carry out this testing under the direction of a panel of independent scientists.  EPA states that it finds the petitioners have not provided the facts necessary for it to determine for each of the 54 PFAS that “existing information and experience are insufficient and testing of such substance or mixture with respect to such effects is necessary to develop such information.”  After “careful consideration,” EPA denied the TSCA petition for the following reasons:

  • Insufficient Information and Experience:  According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” for each of the 54 PFAS.  The petitioners state, in part, “[f]or the 54 PFAS, the sufficiency of available information should be determined by comparing available data with the known adverse effects of other PFAS.  The goal should be to conduct a scientifically sound assessment of each of the 54 chemicals for the critical toxic endpoints that have been identified in studies on [perfluorooctane sulfonate (PFOS)], [perfluorooctanoic acid (PFOA)] and other well-characterized studies.”  EPA states that the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience, however;
     
  • Testing of Such Substance or Mixture with Respect to Such Effects Is Necessary to Develop Such Information:  According to EPA, the petitioners do not demonstrate “testing of such substance or mixture with respect to such effects is necessary to develop such information.”  EPA finds that the petitioners failed to address ongoing testing and data collections for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish there is a need for the testing sought in the petition.  According to EPA, this research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA Section 4(a)(1)(A)(i)(III);
     
  • Class-Based Approach to Testing:  TSCA Section 4(h)(1)(B)(ii) “encourage[s]” EPA to consider “the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category.”  EPA states that it “is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities.”  EPA notes that it collaborated with the National Toxicology Program (NTP) “to construct a PFAS screening library subset composed of 75 PFAS on a structural category basis and considerations such as structural diversity within a category, data availability, and read-across category-level weight (e.g., value of substance for anchoring read-across trends within a category, serving as an analog); four of the 54 PFAS the petitioners identify are included in this subset.”  While the petitioners mention this effort, they “incorrectly state that just two of the 54 PFAS the petitioners cover are included in the EPA testing.”
     
  • Practicability of National Academy of Sciences Oversight:  The petitioners also request that the National Academy of Sciences (NAS) oversee all aspects of the proposed testing program.  EPA states that it “finds such an oversight arrangement is not within the scope of what a TSCA section 21 petitioner can request when seeking the initiation of a rule or the issuance of an order under TSCA section 4.”  Furthermore, according to EPA, projects and studies must meet certain conditions for the NAS to accept private funding.  EPA concludes that it is not in a position to require NAS to oversee the testing requested by the petitioners, and the petitioners provide no administrative or organizational procedures for implementation.
     
  • Selection of PFAS for Health and Environmental Effects Testing:  The petitioners divide the 54 PFAS at issue into Tier 1 substances “for which there is known human exposure based on detection in blood, food or drinking water,” and Tier 2 substances “for which human exposure is probable based on detection in environmental media.”  According to EPA, the petitioners do not set forth facts showing that for all 40 PFAS it ranks as Tier 2 substances “human exposure is probable based on detection in environmental media” or that “a strong inference of exposure can be drawn from their presence in surface water, stormwater, wastewater, sediment, groundwater, soil, private wells, and/or air emissions,” however.
     
  • Scientific Standards:  EPA states that it “finds the petitioners have not evaluated the quality of the data they have provided or indicated how they conducted their searches, evaluated the quality of the sources, or indicated what gaps were located and then explained why the specific tests requested, as compared to others, would provide the data being sought.”  According to EPA, such an evaluation is necessary for EPA to conduct the considerations under TSCA Section 26(h).
     
  • Vertebrate Testing:  TSCA Section 4(h) requires that EPA reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA Section 4.  EPA states that it must consider “as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including (i) Toxicity information; (ii) Computational toxicology and bioinformatics; and (iii) High-throughput screening methods and the prediction models of those methods.”

More information on the TSCA Section 21 petition is available in our October 29, 2020, memorandum, “TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS.”


 

By Lynn L. Bergeson and Carla N. Hutton
 

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists.  EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case).  If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding.  If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register.  The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Christopher R. Blunck and Lynn L. Bergeson

In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce.  In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21.  EPA goes on to state “[‌u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.”  The acknowledgement letter further states that “EPA will, however,  consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” 

As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.  A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

During the week of June 15, 2020, the U.S. District Court for the Northern District of California heard from the U.S. Environmental Protection Agency’s (EPA) final three witnesses:  Dr. Joyce Tsuji, Dr. Ellen Chang, and Dr. Tala Henry.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  Dr. Tsuji did not dispute that fluoride can be a neurotoxin at “high enough levels.”  Dr. Tsuji contended that the scientific literature remains too limited to establish linkage between fluoride and adverse health outcomes.  Dr. Chang testified on the application of systematic review to chemical usage, a process EPA explored at length with its first witness, Dr. Kris Thayer, as reported in our June 12, 2020, blog item.

Dr. Henry defended the EPA Office of Pollution Prevention and Toxics’ (OPPT) decision to deny plaintiffs’ Section 21 petition.  As Director of EPA's Risk Assessment Division, Dr. Henry expressed the view that “robust science” warranted rejection of the petition.  On June 17, 2020, plaintiffs called back Dr. Kathleen Thiessen as a rebuttal witness, who testified briefly in response to the criticism by EPA’s witnesses of plaintiffs’ methodology in studies mentioned earlier in the trial. After Dr. Thiessen’s testimony, the trial moved to closing arguments.

Plaintiffs’ closing argument asserted that EPA failed to quantify what fluoride levels were dangerous to humans.  District Judge Edward M. Chen interceded to inquire in this regard as tests showing neurotoxicity were well above the level in fluoridation chemicals introduced into water.  Plaintiffs argued the necessity of taking into account inter-species differences from animal testing, as well as human-to-human differences.  Plaintiffs stated that this lack of data seriously hinders determining at what level susceptibility can be found.

EPA responded in its closing that studies relied on by plaintiffs are limited by confounding variables, lack of comparison groups, and double-blind methodologies.  Additionally, EPA noted inconsistencies among the reports plaintiffs cited.  Judge Chen followed up with questions regarding the counter-intuitive findings of effects from fluoride exposure in adult rats but not infants and wanted to confirm if this was a byproduct of the quality of research.  EPA replied that there is insufficient evidence to defend an IQ-urine connection.  Judge Chen also asked if the court could find unreasonable risk from the chemical used by EPA without causation of neurological effects. EPA responded that the only standard provided in the Toxic Substances Control Act (TSCA) regarding unreasonable risk is that which results from an evaluation of that risk, not causation.

After hearing closing arguments, Judge Chen noted that the evidence presented by both parties was not confined to the administrative record and that he allowed both parties to use evidence that was available after plaintiffs filed their petition in 2016 Judge Chen asked plaintiffs and EPA to consider how to reach an agreement, including plaintiffs submitting a new petition or EPA reconsidering its denial of the petition.  Pending Judge Chen's request for additional briefing, there was no ruling on what could potentially be the first half of a bifurcated trial.  A status conference is tentatively scheduled for August 6, 2020, at 10:30 a.m. (PDT).


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

The U.S. District Court for the Northern District of California began hearing oral arguments on June 8, 2020, in a case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  The plaintiffs filed suit following the U.S. Environmental Protection Agency’s (EPA) denial of a TSCA Section 21 petition requesting it to exercise its Section 6 authority to prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.  On June 12, 2020, Dr. Kathleen M. Thiessen testified as the final witness for the plaintiffs’ case-in-chief regarding risk analysis to determine a level of fluoride that does not produce adverse effects.  Thiessen also testified about a study that found correlation between fluoride intake and diminished thyroid productivity.  EPA’s first witness, Dr. Kristina Thayer, clarified the types of experimental biases and processes to vet bodies of evidence.  Earlier in the week, plaintiffs’ expert witnesses summarized the scientific literature on the adverse effects of fluoride on children’s development, including lowered IQ.  The experts have cited both animal and human studies.  EPA has questioned them at length regarding the discrepancies between male and female test subjects, especially in relation to prenatal fluoride exposure.  EPA has argued that the data presented by plaintiffs suffers from inconsistencies, flawed methodologies, and biases.  The trial will resume on Monday, June 15, 2020.  Readers interested in watching the trial remotely can find scheduling and Zoom information here.


 
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