We’ve known for years that 6 million Americans’ tap water is contaminated with PFOA and PFOS, just two of thousands in a class of “forever” chemicals known as PFAS (per- and polyfluoroalkyl substances), at levels above the U.S. Environmental Protection Agency’s (EPA’s) “Health Advisory.” We also know that tens of millions more Americans likely are consuming water that contains PFAS—by some accounts more than 100 million of us may be exposed merely by taking a sip of tap water or cooking with it.
Yet, EPA has not set an enforceable drinking water standards for a single PFAS. And if it decided to or were told to do so, would EPA set standards that protect our most vulnerable people like pregnant moms and children? Regrettably, the answer is probably not. This is in part because the Safe Drinking Water Act (SDWA) is, in the words of a major investigative report, “broken.” It is also in part because the Trump Administration is intransigent.
Since the PFAS crisis first came to light, some have been calling on the EPA to set drinking water standards to clean up our drinking water. Indeed, we have suggested that a PFAS standard is ultimately needed and clearly those calling for a standard are well-intentioned and want to protect the public from this scourge. But it is important to explain why badly-needed repairs to the underlying statute should support such an effort. Unless EPA is expressly required to protect vulnerable populations such as pregnant and nursing moms, infants and children, and to establish the most stringent standard feasible, the agency can at most be expected to establish weak standards that will likely undercut state efforts to set strict, health-based protections.
Can’t We Count on the Safe Drinking Water Act to Set Health-Protective Standards?
The short answer is no. You might ask, for example, if the PFAS (or any other) problem is so widespread and serious, why hasn’t the EPA addressed the problem under the Safe Drinking Water Act? This is because: (1) the Safe Drinking Water Act was seriously weakened by 1996 Amendments that have made establishment of protective standards very unlikely; and (2) despite repeated promises to act, the Trump Administration has not even formally made the finding that drinking water standards are needed, much less proposed a standard for any PFAS compound. And even if EPA were to move forward with new tap water rules—or were ordered by Congress to do so—it is unlikely that the agency would set strict, health-protective standards because of the serious flaws in the Act enacted in 1996.
Experience with the 1996 Safe Drinking Water Act Shows the Act Is Broken
Experience with the 1996 law is instructive:
- Perchlorate. Most recently, when EPA was ordered by a court to set a standard for the rocket fuel component perchlorate that’s found in up to 16 million peoples’ tap water, the agency proposed in June 2019 to set a standard at nearly 4 times the agency’s own Health Advisory (the estimated safe level), and said it might set it at 6 times the Health Advisory level, or might set no standard at all. The proposed standard is nearly 10 times higher than the California standard, and 28 times higher than the Massachusetts standard. A group of over 50 health scientists and health and other groups recently wrote to express their “strong opposition” to EPA’s proposal that they said would “leave millions of Americans unprotected.”
- Arsenic. EPA also used the 1996 law when updating the arsenic standard in 2001. The agency found arsenic is a known human carcinogen and that it could be feasibly treated to 3 ppb, yet based on the series of cost-benefit and other requirements of the SDWA, set a standard of 10 ppb instead. The National Academy of Sciences found that year that arsenic poses a cancer risk of greater than 1 in 333 at the EPA standard of 10 ppb (about 3,000 times higher than EPA’s usual target maximum cancer risk of 1 in 1 million). Yet the agency decided based on the SDWA-required cost-benefit provisions to set (and has stuck with) a 10 ppb standard, in the face of substantial political pressure not to set a stricter number.
This is the result of a gutted law.
Specifically, What’s Wrong with the Safe Drinking Water Act?
In 1996, early in the “Gingrich Revolution,” Congress overhauled the Safe Drinking Water Act. While Congress improved certain parts of the law in the 1996 Amendments, they rolled back its standard-setting provisions. The Amendments weakened EPA’s ability to set health-protective standards and eliminated key provisions that had previously required EPA to establish numerous standards.
The result has been EPA has not adopted a single new drinking water standard under the unregulated contaminant standard setting provisions of the Act in the 23 years since the 1996 Amendments. (While some in industry have asserted that this is “an urban legend,” in fact this is true; the handful of new standards that have been set since 1996 were either explicitly mandated by Congress (updated microbial and disinfection byproducts rules, and groundwater rule), or were part of a package of statutorily-mandated updates of preexisting rules (e.g. in the radionuclides rule). See SDWA §1412(b)(2)(C); (b)(8); (b)(9); (b)(12) and (b)(14)). The only strong, health-protective rules established since the 1996 Amendments were the microbial and disinfection byproducts standards, which Congress explicitly ordered EPA to issue, and also explicitly exempted from the provision in the Act that allows feasible standards to be weakened based upon cost-benefit analysis (see SDWA §1412(b)(6)(C)).
How did the 1996 Amendments Make Health-Protective Standards Unlikely?
The Absurd Gauntlet EPA Must Run and Defend from Industry Challenges and OMB Interference
The 1996 Amendments erected an extraordinary set of hurdles for EPA to jump before it can set a standard that make it difficult to establish health-protective rules, even if the agency chose (or was ordered) to do so. Those hurdles create a nearly endless source of possible challenges for industry unhappy with an EPA standard, or for the industry-friendly Office of Management and Budget (OMB) in the White House to kill a rule before it ever sees the light of day.
Specifically, under section 1412 of the Act, for EPA to set a new standard for an unregulated contaminant, generally:
- EPA establishes a “Contaminant Candidate List” (CCL) once every 5 years, from which EPA will consider establishing a standard. Two PFAS, namely PFOA and PFOS, have been on the CCL since 2009.
- EPA Issues an Unregulated Contaminant Monitoring Rule (UCMR), which will require larger water systems to test for the contaminant (and EPA will test a couple of percent of the smaller systems). This is a 5-year process under which EPA proposes a UCMR, finalizes the UCMR, and then takes a few years to implement it. Then EPA collects the data and analyzes it. While EPA is not per se required to hold off on setting rules until it has UCMR data, EPA has generally waited for such data before determining whether a standard is needed. EPA did require UCMR monitoring for six of the PFAS chemicals and the data were collected in 2013-2015, but the agency hasn’t taken any formal regulatory steps since then.
- To start the regulatory process for a contaminant, EPA must make a “Regulatory Determination” after making 3 formal findings that:
- The contaminant may have an adverse effect on health;
- The contaminant occurs (or likely occurs) in public water systems “with a frequency and at levels of public health concern”; and
- Regulation of the contaminant “presents a meaningful opportunity for health risk reduction” for those served by public water systems. This phrase isn’t defined.
- Once every 5 years EPA must make a “regulatory determination” as to whether (or not) to regulate at least 5 contaminants from the CCL. It hasn’t done so for any PFAS. The agency self-selects contaminants from the CCL and may simply decide that none of the 5 or more contaminants is worthy of regulation—as it has done repeatedly since 1996. One exception: after EPA initially said that perchlorate (not a PFAS) didn’t need to be regulated, EPA reversed itself in 2011 and said a standard was needed. (Since then, it hasn’t issued a final standard and, as noted earlier, the agency recently proposed a Maximum Contaminant Level (MCL) for perchlorate that is nearly 4 times higher than its Health Advisory).
- If EPA decides to propose a standard, the agency generally must run an extraordinary gauntlet first, including conducting an extensive series of analyses including risk assessments, cost-benefit analyses, technology assessments etc., that create extensive hurdles for standard setting, and many “hooks” for industry challenges and OMB interference, including:
- Using “the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices”—undefined terms that seem intended to create a toehold for challenges to EPA’s scientific evaluations.
- Using “data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data);”
- Analyzing “each population addressed by any estimate” of public health effects;
- Stating the “expected risk or central estimate of risk for the specific populations;”
- Evaluating “each appropriate upper-bound and lower-bound estimate of risk;”
- Stating “each significant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty;”
- Reviewing peer-reviewed studies “that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data.”
- Completing a “Health Risk Reduction and Cost Analysis” (HRRCA) analyzing:
- Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur as the result of treatment to comply with each level.
- Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur from reductions in co-occurring contaminants that may be attributed solely to compliance with the maximum contaminant level, excluding benefits resulting from compliance with other proposed or promulgated regulations.
- Quantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record to conclude that such costs are likely to occur solely as a result of compliance with the maximum contaminant level, including monitoring, treatment, and other costs and excluding costs resulting from compliance with other proposed or promulgated regulations.
- The incremental costs and benefits associated with each alternative maximum contaminant level considered.
- The effects of the contaminant on the general population and on groups within the general population such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that are identified as likely to be at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.
- Any increased health risk that may occur as the result of compliance, including risks associated with co-occurring contaminants.
- The “quality and extent of the information, the uncertainties in the analysis,” and “factors with respect to the degree and nature of the risk.”
- Determining “whether the benefits of the maximum contaminant level justify, or do not justify, the costs” based on these analyses.
- Determining what “feasible” technologies are available to large systems and listing technologies that are affordable for small systems.
- EPA is authorized to set a standard for a contaminant that is weaker than is feasible to achieve if it finds based on cost-benefit analysis that the benefits of the standard would not justify the costs. In such a case, EPA may set the standard that is justified by the cost-benefit analysis (with certain exceptions). As observers of these analyses can attest, it is far harder to establish and monetize the economic and other benefits of improved public health as compared to quantifying costs, thus tilting the playing field in favor of opponents of strong standards. This is the provision that EPA used to justify setting a revised standard for arsenic of 10 ppb, which as noted earlier the National Academy of Sciences said poses more than a 1 in 333 cancer risk, rather than a 3 ppb standard, which the agency admitted was feasible.
- Emergency authority for “urgent threats to public health.” While EPA has never used this authority, the agency is authorized to act before it has completed many of these analyses if it finds there’s an “urgent threat to public health.” This term is undefined. If EPA uses this authority, however, the agency must go back after setting an interim standard and complete the full array of studies within 3 years and reevaluate the interim standard within 5 years once those studies are complete.
Conclusion: Don’t Expect Protective Tap Water Standards Unless the Law Is Fixed
Ultimately we need a drinking water standard for PFAS. However, it is highly unlikely that protective standards will be set for PFAS or other contaminants unless the SDWA is fixed. Even if a strong EPA Administrator wanted to set protective drinking water standards, it would be challenging for the agency to run the series of hurdles established in the Act and get strong PFAS standards established under the current law. This is because collectively, the provisions of the Act are stacked against EPA setting strict standards. It includes a plethora of requirements that steer the agency to justify its action based upon monetizable benefits that are difficult to conclusively demonstrate (while costs are easy to calculate). It requires the agency to seek to collect extensive health, economic and other data it generally doesn’t have, to reach a degree of certainty about health benefits that generally are extremely difficult to achieve, and to conduct a series of detailed analyses on costs and benefits that can be second-guessed and legally challenged in industry litigation on numerous statutory grounds. This has largely paralyzed EPA from picking any new contaminants off its “contaminant candidate list” and regulating it. Thus, if EPA is ordered to set health-protective drinking water standards, it must be required to set standards that are will ensure protection of all vulnerable populations including pregnant moms, infants and children and are as stringent as feasible, without regard to the innumerable barriers in the 1996 Amendments.