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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules
ChemView returned records for 17 of the 54 PFAS. For example, for perflouromethylperfluorovinyl ether CAS No. 1187935, a substantial risk report is available from DuPont Haskell Global Centers on reproduction/
developmental toxicity screening tests OECD 422/OPPTS 870.3650, one of the methods identified in the petitioners testing program in rats Ref. 17. The petitioners do not mention this report, nor do they explain why the report fails to provide the data being sought. In this way, the petitioners once again have not provided the facts necessary to show that the information in ChemView is insufficient.
Tetrafluoroethylene CAS No. 116
143 is pre-registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH
regulation. The European Chemicals Agency ECHA has compiled chemical/
physical property data partition coefficient, potential for bioaccumulation, etc. for this PFAS.
Hexafluoropropylene CAS No. 11615
4 is also pre-registered under REACH, and ECHA has compiled some chemical/physical property data for this PFAS. The petitioners mention none of these data, nor have they provided the facts necessary to show that this information is insufficient.
TSCA section 21 requires the petitioner, not EPA, to set forth the facts which it is claimed establish that it is necessary to issue, amend, or repeal a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5e. Because EPA, upon a cursory review, has been able to easily identify existing, reasonably available information not mentioned in the petition, the petitioners have failed in carrying their burden of setting forth facts which are necessary to demonstrate that there is insufficient information, thereby necessitating the requested action.
For one of the 54 PFAS, identified only as N1AF, the petitioners provide no structurally-descriptive chemical name, structure, or molecular formula.
Absent such identifying information, the petitioners have not provided the facts necessary to determine whether there is insufficient information or experience for this chemical.
Because the petitioners are seeking tests for each of the 54 PFAS, the petitioners must set forth facts that establish it is necessary to pursue the rule or issue the order the petitioners seek under TSCA section 4. The petitioners must affirmatively demonstrate, through facts, that there is insufficient information and experience for each of the 54 PFAS.

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For the reasons described in this document, EPA finds the petition does not set forth facts necessary to demonstrate insufficient information and experience for each of the 54
PFAS, and has therefore not demonstrated that the rule or order requested is necessary.
2. Testing of Such Substance or Mixture With Respect to Such Effects Is Necessary To Develop Such Information 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. This research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA
section 4a1AiIII. Testing, both planned and underway, on some of the 54 PFAS that the petitioners identify is described in this unit:
Five of the 54 PFAS have been subjected to all Tier 1 in vitro, toxicokinetic, and clearance studies:
Hepatotoxicity, developmental toxicity, immunotoxicity, mitochondrial toxicity, developmental neurotoxicity, endocrine disruption, general toxicity, intrinsic hepatic clearance, plasma protein binding PPB, and renal reuptake.
These studies are ongoing and results are expected by April 2021. Data are expected to be available via the PFAS
Dashboard by the end of June 2021.
An additional six of the 54 PFAS
have results from some Tier 1 in vitro testing. Two have been included in systematic evidence mapping SEM, a systematic review approach used to identify available data and characterize knowledge gaps.
Three of the 54 PFAS have in vivo data identified from a non-EPA source.
In addition, the following studies are planned or in process by EPAs Office of Research and Development ORD.
ORD will test for nuclear receptor and stress gene responses of a PFAS
library in HepG2 cells. This research will apply a high-throughput assay for transcription factor activation to screening the first and second PFAS
screening sets totaling 150 samples.
Additional samples may be added to meet developing needs. This assay platform contains known targets of several PFAS including the estrogen receptor and peroxisome proliferatoractivator receptors, as well as many other potential targets. Well-studied
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PFAS such as PFOA and PFOS will be included to help put findings for datapoor chemicals in better context. Data sets will support development of readacross and category approaches for this class of chemicals.
Bioactivity of PFAS as determined using gene expression and in vitro cellular pathology is another area of ongoing research at EPA. This research will apply broad-based high-content screening assays to characterize the bioactivity of a set of PFAS in multiple human cell types. The resulting dataset will contribute to an overall assessment of the effects of PFAS on important physiological functions that overlap with effects measured in the testing the petitioners requested.
ORD will also conduct highthroughput in vitro testing of PFAS to fill data gaps and refine structural and mechanistic groupings. This project falls under the Human Health Testing/
Toxicokinetics research area that will generate and analyze a large data set on 150 PFAS using a variety of New Approach Methodologies NAMs in support of EPAs mission to manage and regulate PFAS. This research effort will add a dataset of NAMs testing results for 15 PFAS. Selection of these 15
chemicals will be driven by the initial analysis of the 150 chemicals and provide the ability to fill identified data gaps and potentially test hypotheses developed from the initial analysis.
Testing of these 15 PFAS will include transcription factor activity profiling;
estrogen-dependent cell proliferation;
high-content, cellular phenotypic imaging; high-throughput transcriptomics; zebrafish embryo development; and developmental neurotoxicity. The results will support the overarching EPA PFAS research to:
1 Develop a hierarchical scheme of chemical structural categories that are enriched by NAM data; 2 Use categories as predefined neighborhoods to evaluate degree of concordance in NAM results within categories and across categories as a means to infer in vivo toxicity; 3 Predict categorization of larger PFAS inventory and readacross coverage; and 4 Recommend further in vivo testing for PFAS
categories.
In the FY2020 Further Consolidated Appropriations Act Pub. L. 11694, Congress appropriated funds for EPA to address research needs in support of designating PFAS as hazardous substances under CERCLA. The research needed to help support this designation include: Chemical and physical characteristics of PFAS; Toxicity and kinetic information; environmental prevalence; Manufacturing and use
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