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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules IV. Disposition of TSCA Section 21
Petition
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A. What was EPAs response?
After careful consideration, EPA has denied the petition. A copy of the Agencys response, which consists of the letter to the petitioners and this document, is posted on the EPA petition website at https www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/tsca-section-21reporting.
The response, the petition Ref. 1 and other information is available in the docket for this TSCA section 21 petition see ADDRESSES.
The denial is not based on lack of concern with PFAS. In fact, EPAs high concern for these chemicals is detailed in Unit III. of this document. EPA is leading the national efforts to understand PFAS and reduce PFAS
risks to the public through implementation of its PFAS Action Plan and through active engagement and partnership with other federal agencies, states, tribes, industry groups, associations, local communities, and the public. Instead, EPA finds the petitioners have not met their burden under TSCA section 21, as explained in Unit IV.B. of this document.
B. What was EPAs reason for this response?
In considering the petition within the statutory 90-day petition review period, EPA evaluated the information presented or referenced in the petition and considered that information in the context of the applicable authorities and requirements contained in TSCA
sections 4, 21, and 26. Also, notwithstanding that the burden is on the petitioners to present the facts which it is claimed establish that it is necessary for EPA to initiate the rule or issue the order sought, EPA
nonetheless also evaluated relevant information that was reasonably available to the Agency during the 90day petition review period.
As detailed extensively in the units that follow, EPA finds the petitioners have not provided the facts necessary for the Agency 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. These deficiencies, among other findings, are detailed in this document.
1. Insufficient Information and Experience The petition does not set forth the facts necessary to demonstrate that there is insufficient information and
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experience for each of the 54 PFAS.
The petitioners state, in part, for 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 PFOS, PFOA and other wellcharacterized studies Ref. 1, pg. 21.
However, the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience.
The petitioners instead point to broad statements in the EPA PFAS Action Plan, such as there are many PFAS of potential concern to the public that may be found in the environment. Most of these PFAS lack sufficient toxicity data to inform our understanding of the potential for adverse human or ecological effects Ref. 3, pg. 31. The petitioners base the fate and transport studies they request on EPAs PFAS
Action Plan, which the petitioners quote as stating information for many PFAS
sources, fate and transport, and human and ecological exposure is sparse, both spatially and temporally Ref. 3, pg.
31. However, the PFAS Action Plan broadly states only that such information for many PFAS sources is sparse; nowhere does it state or conclude that such information is sparse for each of the 54 PFAS the petitioners identify. To further demonstrate that the information and experience on the 54
PFAS is allegedly insufficient, the petitioners cite ATSDRs 2018
Toxicological Profile for perfluoroalkyls, which the petitioners acknowledge identifies numerous critical data gaps for PFAS as a class emphasis added.
The ATSDR 2018 Toxicological Profile for perfluoroalkyls remains in draft form and discusses information on 14
perfluoroalkyl compounds, none of which are among the 54 the petitioners identify. Importantly, the ATSDR 2018
Toxicological Profile further states that the term perfluoroalkyls used throughout the toxicological profile is referring to these 14 compounds and the information may not be applicable to other perfluoroalkyl compounds Ref.
2, pg. 1. Despite this qualifying statement, the petitioners proceed to state without reference or additional explanation that the 54 substances covered by this petition fit this pattern Ref. 1, pg. 21. This extrapolation is fundamentally important to the petitioners argument, yet there are no facts in the petition to support the statement. The petitioners are not clear
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as to what pattern the 54 PFAS fit, and no other sources are provided.
Absent any factual support in the petition, EPA finds that mere reference to these broad statements from the EPA
PFAS Action Plan and ATSDRs 2018
Toxicological Profile for perfluoroalkyls does not provide the facts necessary for the Agency to determine there is insufficient information or experience for these 54 PFAS.
To further characterize this baseline deficiency, EPA performed a cursory search of public literature and databases for reasonably available information on any of the 54 PFAS identified by the petitioners. Representative findings of this cursory review are summarized as follows:
On June 8, 1987, EPA issued a Final Test Rule for Fluoroalkenes Ref. 14
requiring testing for certain health effects for four fluoroalkenes, two of which are among the 54 PFAS the petitioners identify:
Hexafluoropropylene CAS No. 11615
4 and tetrafluoroethylene CAS No.
116143. The petitioners do not identify this test rule and the testing it required, nor do the petitioners explore and explain why the testing the rule ordered did not generate the health effects data the petitioners are now requesting.
EPAs web-based CompTox Chemistry Dashboard integrates various types of data for curated substances linked to chemical structures, including physicochemical, environmental fate and transport, exposure, usage, in vivo toxicity, and in vitro bioassay data Ref.
15. A query for some of the 54 PFAS
in CompTox returned physical/chemical property and hazard data. For example, CompTox has published experimental averages for melting point, boiling point, water solubility, and vapor pressure, and some hazard data and sources for tetrafluoroethylene CAS No.
116143. CompTox also has published some hazard data for hexafluoropropylene CAS No. 11615
4 and perflouromethylperfluorovinyl ether CAS No. 1187935. Finally, some physical/chemical data for perfluoro 4-methyl-3, 6- dioxaoct-7ene sulfonyl fluoride CAS No. 16090
145 are also readily available. The petitioners mention none of these data, nor have they provided the facts necessary to show that the information in CompTox is insufficient.
ChemView provides the public access to reports and dataset information including data submitted to EPA, EPA Assessments and Actions, and data provided by other EPA Offices and federal organizations Ref. 16. A
query for each of the 54 PFAS in
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