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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules information; and Information on the regulatory status of PFAS. This ongoing research will add significantly to currently available hazard information for PFAS that could be used for this designation, as well as for risk assessment use broadly by Program Offices.
NDAA section 7351 amended TSCA
section 8a to include a one-time reporting event of PFAS manufactured including imported in any year since January 1, 2011. TSCA section 8a7
authorizes EPA to collect all existing information concerning the environmental and health effects of such substance or mixture. Under this rule, EPA may collect information that overlaps with some of the information requested by petitioners. A final TSCA
section 8a rule for these PFAS must be issued by January 1, 2023, and EPA has initiated the relevant rulemaking process for the proposed rule that is expected to be issued in 2021.
The petitioners also call for an epidemiologic study consisting of 100,000 participants from communities exposed to PFAS-contaminated drinking water. A similar, multi-site health study is being implemented through the Centers for Disease Control and Prevention and ATSDR cooperative agreements. As ATSDR states, information learned from the multisite study will help all communities in the U.S. with PFAS exposures, including those that were not part of the study. The petitioners mention this multi-site study but provide no analysis of overlap or what testing might be duplicative with what is proposed and thus might not be necessary, whether based on community characteristics, demographics, specific PFAS or mixture, or levels of exposure.
For some of the 54 PFAS, only a degradant is detected in the Cape Fear River per the information provided by petitioners, not the parent chemical for which the petitioners have requested testing. The petitioners have not identified why it is necessary to test the parent chemicals and not the degradants actually detected in the Cape Fear River.
For example, the petitioners do not demonstrate that testing of the parent chemical would identify effects relevant to the degradants.
The petitioners specifically identify and acknowledge that 5 of the 54 listed chemicals in this petition are also designated for testing in the Chemours North Carolina consent decree. These tests would not need to be replicated in response to this petition Ref. 1, pg.
30. EPA finds this avoidance of duplicative testing tacitly acknowledges that for these five PFAS, testing is not
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necessary to develop information on health or environmental effects. The petitioners attempt to avoid duplicative testing as a result of the Chemours North Carolina consent decree, but no other duplicative testing, further emphasizes their failure to address readily available information concerning the other activities EPA has identified in this unit.
3. Class-Based Approach to Testing TSCA section 4h1Bii encourages 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.
Accordingly, EPA is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities Ref. 18. EPA and the National Toxicology Program collaborated 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 categorylevel 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 Ref. 19. The petitioners mention this effort, but incorrectly state that just two of the 54
PFAS the petitioners cover are included in the EPA testing Ref. 1, pg. 22.
The petitioners take the opposite approach, requesting testing on each of the 54 PFAS individually. The petitioners fail to address why a classbased approach is not appropriate, while also indirectly referring to the efforts to address PFAS as a class. For example, the petitioners allege that conclusions about all 54 PFAS can be based on the ATSDR 2018 Toxicological Profile even though none of the 54
PFAS are addressed in the toxicological profile, and concedes that the ATSDR
2018 Toxicological Profile identifies numerous critical data gaps for PFAS as a class emphasis added.
Additionally, among the references allegedly supporting the assertion that PFAS present serious health and environmental concerns, the petitioners cite a commentary entitled Scientific Basis for Managing PFAS as a Chemical Class Ref. 20. This commentary acknowledges PFAS demand a more efficient and effective approach when it comes to testing and seeks to provide
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scientific justification for why a classbased approach is appropriate and necessary for all PFAS. Because the petitioners acknowledge the 54 PFAS
share similarities with other members of the class, and the petitioners do not explore these similarities as a means of streamlining the extent of the testing requested, or to inform the petitioners tiered screening and testing process, EPA finds the petitioners have not provided the facts necessary to determine, for each of the 54 PFAS, that testing of such substance or mixture with respect to such effects is necessary to develop such information.
Therefore, they have not demonstrated that the rule or order they requested is necessary.
4. 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 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. Further, projects and studies must meet certain conditions for the NAS to accept private funding. As an example, NAS does not generally oversee studies where the study sponsor would have a direct financial interest in the outcome of the testing program. EPA 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.
5. Selection of PFAS for Health and Environmental Effects Testing Attachment 2 of the petition divides 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. However, 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 Ref. 1, pg. 19. The petitioners support their assertion that some of the Tier 2 PFAS were detected in environmental media with two studies Ref. 21, 22; for nine of these, no other studies are provided for
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