By Lynn L. Bergeson and Carla N. Hutton
 
On November 15, 2022, a coalition petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to require human and environmental health and safety testing for polyvinyl alcohol (PVA/PVOH) as it is used in consumer-packaged goods, “with particular attention to the use of PVA in laundry and dishwasher detergent pods and sheets.” The petitioners request that until such testing is completed, EPA remove PVA/PVOH from its Safer Choice Program “to curb plastic pollution.”
 
The coalition was filed on behalf of Blueland and Plastic Pollution Coalition, as well as the following “leading nonprofit organizations fighting plastic pollution and climate change”: Beyond Plastics; Plastic Oceans International; The Shaw Institute; Lonely Whale; 5 Gyres; GAIA (Global Alliance for Incinerator Alternatives); Oceanic Global Foundation; The Last Beach Cleanup; Rio Grande International Study Center; Inland Ocean Coalition; Occidental Arts and Ecology Center; Turtle Island Restoration Network; Friends of the Earth; Surfrider; and Made Safe.
 
The American Cleaning Institute (ACI) released a statement on November 15, 2022, regarding the “misinformation that is being spread about PVA/PVOH.” ACI states that it “believe[s] this recent effort by NGOs to petition the EPA is part of an ongoing marketing campaign funded by a company with an interest in preventing other companies from using this technology.” According to ACI, the marketing campaign “ignores decades of science and research demonstrating the biodegradability of this chemistry.”
 
EPA is required to grant or deny TSCA Section 21 petitions within 90 days from the day the petition is filed with EPA. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, EPA must publish the reasons for its denial in the Federal Register.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our July 18, 2022, blog item, the U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” In a September 14, 2022, letter, EPA denied the petition. According to the letter, of the various actions described in the petition, EPA determined that only the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) is within the ambit of a TSCA Section 21 petition. EPA states that based on its review, and after careful consideration of the specific requests, it is denying the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) because, “although EPA shares the petitioners’ concerns regarding the threat posed by climate change, the Agency found that the petition was insufficiently specific and failed to establish that it is necessary to issue a rule under TSCA section 6, in light of ongoing and expected federal government actions, the relative efficiency of TSCA rulemaking, and lack of TSCA section 6(a) authority to regulate historical GHG emissions.” EPA will publish in a forthcoming Federal Register notice its reasons for denying this portion of the petition, as well as its reasons for declining to address under TSCA Section 21 the other petitioned actions. EPA has posted a prepublication copy of the Federal Register notice.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” EPA acknowledged receipt of the petition in a July 5, 2022, letter. Under TSCA Section 21, EPA has 90 days to grant or deny the portions of the petition eligible for TSCA Section 21. If EPA grants the petition, then EPA “will promptly commence an appropriate proceeding.” If EPA denies the petition in whole or in part, then it will publish the reasons for denial in the Federal Register.

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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.

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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.

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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).”

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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.

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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.”

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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.”

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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.

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