|Action||Amend and update the Waterworks Regulations|
|Comment Period||Ends 3/16/2022|
Dear Mr. Singh:
The 3M Company (3M) appreciates the opportunity to comment on the notice of intended regulatory action (NOIRA) to set maximum contaminant levels (MCLs) for certain per-and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), as well as other substances. 3M is a science-based company with substantial experience, expertise, and product stewardship related to PFAS. It is with that background 3M submits comments on the NOIRA.
The NOIRA states that the State Board of Health (Board) intends “to review the occurrence and public health implications of PFOA, PFOS . . . in public drinking water in Virginia and to establish MCLs for each of the contaminants based on the results of the occurrence study completed in 2021.” The accompanying Agency Background Document explains that the Board will review MCLs adopted by other states, the scientific studies and evidence reviewed by such states, material from the Agency for Toxic Substances and Disease Registry (ATSDR) and Disease Registry of the U.S. Department of Health, and current peer-reviewed scientific studies. 3M has extensively analyzed and commented on the scientific literature cited to by many state agencies in promulgating their MCLs, as have a number of other commenters. 3M strongly encourages the Board to consider not only the MCLs adopted and scientific studies reviewed by other states, but to evaluate and consider the substantive comments submitted on the agency’s action. 3M would be pleased to provide a copy of its comments on any relevant rulemaking if helpful to the Board’s review of state actions.
In addition to any of 3M’s prior comments on regulatory actions by other states, 3M offers the following comments regarding the NOIRA.
Any consideration of an MCL must be based on sound science. In particular, the Board should adhere to well-accepted health risk assessment principles, guidelines and policies. Specifically, follow the two-step process to assess potential health risks: 1) assess the weight of evidence that a substance can cause health effects, considering all evidence, including human, animal, and mechanistic studies; and 2) on the assumption that the agent can cause harm, describe quantitatively the levels at which harm might be induced (dose-response). In addition, the Board should clearly identify the critical endpoint it is trying to protect against and should ensure that its analyses and regulatory approaches are consistent.
Moreover, given the scientific uncertainty regarding the causal effects of PFAS on human health, the Board should carefully analyze the current body of peer-reviewed scientific research. There is a vast body of scientific evidence regarding a number of PFAS that does not show that PFAS cause adverse health effects in humans at current exposure levels, or even at the historically higher levels found in blood prior to the U.S. phase out of PFOS and PFOA. ATSDR recently concluded regarding perfluoroalkyls: “The available human studies have identified some potential targets of toxicity; however, cause-and-effect relationships have not been established for any of the effects, and the effects have not been consistently found in all studies.” ATSDR analyzed hundreds of studies when reaching this conclusion.
3M respectfully submits that the Board should carefully review the full body of relevant peer-reviewed scientific studies and account for the various finding so that any health-risk-based MCLs are informed by and based on sound science.
The Virginia Department of Health’s Office of Drinking Water conducted a study in 2021 purportedly to “generate statewide occurrence data.” That study does not provide an unbiased look at statewide occurrence data, as sampling locations were selected based at least in part on their proximity to locations of suspected PFAS contamination. As such, the data are not representative of statewide occurrence of the sampled PFAS, because the sampling locations were biased in favor of detecting PFAS in the samples. Even so, the data indicates infrequent detections of the sampled PFAS, and where it was detected, the levels were extremely low. PFOA was detected at 4 out of 63 sample locations and the highest detection was 5.5 ppt. Similarly, PFOS was detected at 7 out of 63 sample locations and the highest concentration was 7.1 ppt. These detections are an order of magnitude lower than EPA’s Health Advisory Levels for PFOA and PFOS, and lower than every state-level MCL for those substances adopted to date.
The Virginia statute to adopt MCLs directs the Board to consider MCLs for PFOA and PFOS, and other PFAS “substances as the Board deems necessary.” VA Code Ann. § 32.1-169(B). First, the Board’s determination of when it is “necessary” to consider an MCL for any substance, including those expressly enumerated in the statute, should be based on sound science. Second, 3M respectfully submits that the Board should not regulate PFAS compounds as a class.
Different PFAS have different toxicological properties, bioaccumulation potentials, toxicity levels and effects. As the United States Environmental Protection Agency (“EPA”) has noted, “PFAS vary widely in chemical and physical properties, behavior, and potential risks to human health and the environment. Differences in the chemical structure, carbon chain length, degree of fluorination, and chemical functional group(s) of individual PFAS have implications for their mobility, fate, and degradation in the environment, as well as uptake, metabolism, clearance, and toxicity in humans, plants, and other animals.” For example, the high molecular weight backbone polymers, such as PTFE, FEP, ETFE, and PFA, have been widely cited as being of low concern (Henry et al., and ITRC). 3M supports a rigorous, science-based dialogue and review among regulators, academic researchers, manufacturers, and others to assess and research these substances and encourages the Board to account for these findings and the underlying chemical differences between PFAS molecules as it moves forward with any agency action.
Additionally, to the extent the Board proposes to regulate additional PFAS compounds beyond PFOS and PFOA, it should limit regulation to those PFAS compounds for which there is a substantial body of scientific research and adequate associated testing and sampling methods.
3M appreciates the Board’s consideration of these initial comments.
 Notice of Intended Regulatory Action (NOIRA) Agency Background Document, at 2 (Dec. 1, 2021).
 ATSDR 2021 at p. 751, https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf (emphasis added).
 Virginia Per and Polyfluoroalkyl Substances (PFAS) in Drinking Water Sample Study Summary, https://www.vdh.virginia.gov/content/uploads/sites/14/2021/09/VA-PFAS-Sample-Study-Summary.pdf.
 EPA Multi-Industry PFAS Study – 2021 Preliminary Report (September 16, 2021).
 B. J. Henry, et al, ‘A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers’. Integr Environ Assess Manag, 14, 2018, p. 316-334
 Interstate Technology Regulatory Council, ‘PFAS – Per- and Polyflouroalkyl Substances: Chemistry, Terminology, and Acronyms’, viewed on 2 June 2020 at: https://pfas-1.itrcweb.org/2-2-chemistry-terminology-and-acronyms/