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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Rules and Regulations
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with data collected by states who have made their data publicly available at this time USEPA, 2019b. A summary of these occurrence data were presented in the preliminary Regulatory Determination 4 Federal Register document. Subsequent to the preliminary announcement, based on comments and information received on the proposed determination, the Agency collected additional data from additional states. The finished water data available from fifteen states collected since UCMR 3 monitoring showed that there were at least 29 PWSs where the summed concentrations of PFOA and PFOS exceeded the EPA
HRL. The Agency notes that some of these data are from targeted sampling efforts and thus may not be representative of levels found in all PWSs within the state or represent occurrence in other states. The state data demonstrate occurrence in multiple geographic locations and support EPAs finding that PFOA and PFOS occur with a frequency and at levels of public health concern in drinking water systems across the United States. The Final Regulatory Determination 4
Support Document presents a detailed discussion of state PFOA and PFOS
occurrence information USEPA, 2021a.
EPA acknowledges that there may be other states with occurrence data available and that additional states have or intend to conduct monitoring of finished drinking water. As such, EPA
will consider any new or additional state data to inform the development of the proposed NPDWR for PFOA and PFOS.
c Meaningful Opportunity Considering the population exposed to PFOA and PFOS including sensitive populations and lifestages, the potential adverse human health impacts of these contaminants, the environmental persistence of these substances, the persistence in the human body and potential for bioaccumulation of these substances, the availability of validated methods to measure and treatment technologies to remove PFOA and PFOS, the detections that exceeded the HRL and 12 the HRL, and significant public concerns particularly those expressed in comments submitted by state and local government agencies on the challenges that these contaminants pose for communities nationwide, the Agency has determined that regulation of PFOA and PFOS presents a meaningful opportunity for health risk reduction for persons served by PWSs, including sensitive populations such as infants, children, and pregnant and nursing women.

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PFOA and PFOS are both generated as degradation products of other perfluorinated compounds e.g., fluorotelomer alcohols, and due to their strong carbon-fluorine bonds, are resistant to metabolic and environmental degradation USEPA, 2016b; USEPA, 2016c. Due to this underlying chemical structure, PFOA
and PFOS are extremely persistent in the environment, including resistance to chemical, biological, and physical degradation processes. While most U.S.
manufacturers have voluntarily phased out production and manufacturing of both PFOS and PFOA, their environmental persistence and formation as degradation products from other compounds may still contribute to their release in the environment. Upon exposure to the human body, there is a potential for bioaccumulation and toxicity at environmentally relevant concentrations as studies show it can take years to leave the human body NIEHS, 2020; USEPA, 2016b; USEPA, 2016c.
Adverse effects observed following exposures to PFOA and PFOS include effects in humans on serum lipids, birth weight, and serum antibodies. Some of the animal studies show common effects on the liver, neonate development, and responses to immunological challenges.
Both compounds were also associated with tumors in long-term animal studies USEPA, 2016d; USEPA, 2016e. In determining that regulation of PFOA
and PFOS presents a meaningful opportunity for health risk reduction for sensitive populations, EPA noted that both PFOA and PFOS are associated with developmental toxicity in animals, with reduced birth weight in humans, and have been shown to be transmitted to the fetus via the placenta and to the newborn, infant, and child via breast milk USEPA, 2016b; USEPA, 2016c.
Drinking water analytical methods are available to measure PFOA, PFOS, and other PFAS in drinking water. EPA has published validated drinking water laboratory methods for detecting a total of 29 unique PFAS in drinking water, including EPA Method 537.1 18 PFAS
and EPA Method 533 25 PFAS.
Available treatment technologies for removing PFAS from drinking water have been evaluated and reported in the literature e.g., Dickenson and Higgins, 2016. EPAs Drinking Water Treatability Database USEPA, 2020b summarizes available technical literature on the efficacy of treatment technologies for a range of priority drinking water contaminants, including PFOA and PFOS. In summary, conventional treatment comprised of the unit processes coagulation,
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flocculation, clarification, and filtration is not considered effective for the removal of PFOA and PFOS. Granular activated carbon GAC, anion exchange resins, reverse osmosis and nanofiltration are considered effective for the removal of PFOA and PFOS.
d Summary of Public Comments on PFOA and PFOS and Agency Responses EPA received many comments on the Agencys evaluation of the first statutory criterion under section 1412b1A of SDWA. Most commenters agreed with EPAs finding that PFOA and PFOS may have adverse effects on the health of persons. Most commenters also state that there is strong evidence and substantial scientific evidence for EPAs finding of adverse health effects of PFOA and PFOS. One commenter disagreed with EPAs evaluation of the first statutory criterion, arguing that the body of scientific evidence does not show adverse effects from PFAS in humans. EPA also received numerous comments relating to the Agencys 2016
Lifetime Health Advisory for PFOA and PFOS, the corresponding HESD and the HRL used to support the preliminary regulatory determination. Numerous commenters encouraged EPA to update and improve its health reference level and revise the PFOA and PFOS hazard assessments prior to making a final regulatory determination.
EPA acknowledges commenters suggestions to consider and evaluate newer studies; however, EPA disagrees with recommendations to establish new HRLs prior to a final regulatory determination. Consistent with SDWA
section 1412b3Ai, EPA is using the 2016 PFOA and PFOS Lifetime Health Advisory as the basis in deriving an HRL which the Agency has concluded represent the best available peer reviewed scientific assessment at this time. Based upon the 2016 EPA
HESDs for PFOA and PFOS, and other supporting studies cited in the record, EPA finds that PFOA and PFOS may have an adverse effect on the health of persons. Consistent with commenters recommendations, EPA has initiated the first steps of a systematic literature review of peer-reviewed scientific literature for PFOA and PFOS published since 2013 with the goal of identifying any new studies that may be relevant to human health assessment. An annotated bibliography of the identified relevant studies as well as the protocol used to identify the relevant publications can be found in Appendix D of the Final Regulatory Determination 4 Support Document USEPA, 2021a, available in the docket for this document.
Additional analyses of these new
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