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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules
inclusion based on presence in environmental media Ref. 1, Attachment 2. Three of these nine PFAS were not directly detected in the two studies. Further, for some of these nine PFAS, only degradant products were detected in the Cape Fear River;
the parent compounds the petitioners specifically identify for testing were not.
Thus, for nine of the 54 PFAS, the petitioners provide weak or no evidence for presence in environmental media upon which to base its strong inference of exposure assertion Ref. 1, pg. 19.
6. Scientific Standards
7. Vertebrate Testing
V. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.

TSCA section 4h requires that EPA
reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA section 4. EPA
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.
The testing program the petitioners request would require testing on vertebrates. For example, OCSPP Test Guidelines 850.2300, 870.3650, and 870.7800, among other test guidelines, require vertebrate testing. Due to the number of PFAS involved and tests requested, the petitioners request would require testing on a large number of vertebrates. Yet, as previously discussed, the petition fails to provide reasonably available existing toxicity information on the 54 PFAS, and as such the petition has not provided sufficient facts for EPA to consider reasonably available existing information and encourage and facilitate the use of test methods that reduce or replace the use of vertebrates, group chemical substances as appropriate to reduce the use of vertebrates, and facilitate the formation of consortia for jointly conducted testing.

1. Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, The NC
Black Alliance to Andrew Wheeler, Administrator, Environmental Protection Agency. Petition to Require Health and Environmental Testing Under the Toxic Substances Control Act on Certain PFAS
Manufactured by Chemours in Fayetteville, North Carolina. October 13, 2020.
2. Agency for Toxic Substances and Disease Registry ATSDR. Notice;
Availability of Draft Toxicological Profile:
Perfluoroalkyls. Federal Register. 83 FR
28849, June 21, 2018 Docket No. ATSDR
20150004.
3. EPA. EPAs Perand Polyfluoroalkyl Substances PFAS Action Plan. EPA
823R18004. February 14, 2019. https
www.epa.gov/pfas/epas-pfas-action-plan.
4. EPA. Proposed Rule; Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule.
Federal Register. 80 FR 2885, January 21, 2015 FRL991563.
5. EPA. Consent Order regarding DuPont Premanufacture Notices P08508 and P09
509. 2009. https chemview.epa.gov/
chemview/proxy?filename=sanitized_
consent_order_p_08_0508c.pdf.
6. EPA. Notice of Availability; Lifetime Health Advisories and Health Effects Support Documents for Perfluorooctanoic Acid and Perfluorooctane Sulfonate. Federal Register.
81 FR 33250, May 25, 2016 FRL994691
OW.
7. EPA. Fact Sheet: 2010/2015 PFOA
Stewardship Program. Washington, DC: US
Environmental Protection Agency, Office of Pollution Prevention and Toxics. https
www.epa.gov/assessing-and-managing-

EPA 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. Such an evaluation is necessary for EPA to conduct the considerations under TSCA section 26h.

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C. What was EPAs conclusions?
EPA denied the request to initiate a rule or issue an order under TSCA
section 4 because the TSCA section 21
petition does not set forth 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. Therefore, the petitioners have not demonstrated that the rule or order they requested is necessary.

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8. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New Use Rule.
Federal Register. 67 FR 11008, March 11, 2002 FRL68236.
9. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New Use Rule.
Federal Register. 67 FR 72854, December 9, 2002 FRL72791.
10. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New Use Rule.
Federal Register. 72 FR 57222, October 9, 2007 FRL81504.
11. EPA. Final Rule; Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substances; Final Significant New Use Rule. Federal Register.
78 FR 62443, October 22, 2013 FRL9397
1.
12. EPA. Final Rule; Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule.
Federal Register. 85 FR 45109, July 27, 2020
FRL1001044.
13. EPA. Draft Compliance Guide for Imported Articles Containing Surface Coatings Subject to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances Significant New Use Rule; Notice of Availability and Request for Comment.
Federal Register. 85 FR 81466, December 16, 2020 FRL1001786.
14. EPA. Final Rule; Fluoroalkenes; Final Test Rule. Federal Register. 52 FR 21516, June 8, 1987 FRL32148.
15. Williams, A.J., Grulke, C.M., Edwards, J. et al. The CompTox Chemistry Dashboard:
a community data resource for environmental chemistry. Journal of Cheminformatics. 9, 61.
2017.
16. EPA. Introduction to ChemView. May 28, 2020. https www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
introduction-chemview.
17. DuPont Haskell Global Centers to 8e Coordinator, Office of Pollution Prevention and Toxics, Environmental Protection Agency. Substantial Risk Report for 3,3,3Trifluoromethyl-1,2,2-trifluorovinyl ether, CAS 1187935. November 8, 2007. https
chemview.epa.gov/chemview/
proxy?filename=2007-11-8EHQ-07-16360B_
8ehq_1107_16360b.pdf.
18. EPA. EPA and Partners Describe a Chemical Category Prioritization Approach to Select 75 PFAS for Testing using New Approach Methods. February 26, 2019.
https www.epa.gov/sciencematters/epaand-partners-describe-chemical-categoryprioritization-approach-select-75-pfas.
19. Patlewicz, G. et al. A Chemical Category-Based Prioritization Approach for Selecting 75 Perand Polyfluoroalkyl Substances PFAS for Tier Toxicity and Toxicokinetic Testing. Environmental Health Perspectives 1271. January 11, 2019. https
doi.org/10.1289/EHP4555.
20. Kwiatkowski, C. et al. Scientific Basis for Managing PFAS as a Chemical Class.
Environmental Science & Technology Letters.
7,8:532543. 2020. https doi.org/10.1021/
acs.estlett.0c00255.
21. Strynar, M. et al. Identification of Novel Perfluoroalkyl Ether Carboxylic Acids
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