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Division of Drinking Water
Attn: Jeanine Townsend, Clerk to the Board
State Water Resources Control Board
P.O. Box 100
Sacramento, CA 95812-2000
Re: Comment Letter – SBDDW-20-001: Perchlorate DLR
It’s clear the California State Water Resources Control Board cares very much about providing the cleanest drinking water to the most vulnerable consumers, children. Yet the Water Board’s proposed change does not improve their health and may hurt them by taking necessary resources from the poorest of parents who care for those children.
If the Water Board plans to use force (i.e., statute) to make an essential good more expensive, which will disproportionately affect the poor they claim to want to help, they need better reasons than they have provided. It has been 25 years since perchlorate entered the American vocabulary. Over this time, perchlorate has been investigated and our knowledge of its interactions with our bodies has increased. This lowers the uncertainty that is always built into toxicology models of safety.
The Initial Statement of Reasons is long on statutory authority and nonexistent on need. It lists no technical, theoretical, or empirical studies, reports, or similar documents regarding health or the life-years gained by the imposition of the new proposed regulation. As a peer-reviewed paper notes, “Mere detection of a chemical in the environment cannot be equated with increased risk, but must be evaluated in terms of the hazard, dose-response, and human exposure, all steps in the characterization of health risk.” You cannot shortcut this process. This is what you, the Water Board, are mandated to perform, and a lower Maximum Contaminant Level (MCL) for an inorganic chemical is not a proxy for “safer”.
Simply put, the Water Board has failed to do its due diligence to research the need for a more restrictive Detection Limit for Purposes of Reporting. (See my comments under section IV, below, with details about relevant empirical studies.)
Below is a discussion on each of the items of the Initial Statement of Reasons provided by the State Water Board.
I. BACKGROUND/AUTHORITY (PROBLEM STATEMENT)
“Health and Safety Code (HSC) section 116270 states California’s legislative intent to establish primary drinking water standards at least as stringent as those under the federal Safe Drinking Water Act and to establish a program that is more protective of public health than the minimum federal requirements…. The perchlorate primary drinking water standard is expressed in the form of a maximum contaminant level (MCL) and associated monitoring and reporting requirements as described in HSC 116275, including a Detection Limit for Purposes of Reporting (DLR) as defined in 22 California Code of Regulations (CCR), section 64400.34. The current perchlorate MCL and DLR are 0.006 mg/L and 0.004 mg/L, respectively…. While analytical methods are available to report data at concentrations lower than the current DLR of 0.004 mg/L, many water systems and laboratories quantify reported concentrations only as low as the DLR. The lack of perchlorate occurrence data at concentrations below the current DLR hinders the State Water Board’s ability to evaluate whether technology can achieve a materially greater protection of public health or attainment of the public health goal than the current DLR of 0.004 mg/L, and determine the economic feasibility of lowering the MCL.”
The Water Board’s Problem Statement has a fatal flaw. It fails to demonstrate a need for a lower standard. If this is a health issue, as the Water Board contends, then a problem statement would list how many people are debilitated by the current standard not being stringent enough.
Instead, the Water Board’s Problem Statement is taking it as a given that less of any substance in drinking water that the Office of Environmental Health Hazard Assessment has deemed a pollutant provides “materially greater protection of public health.”
This supposition by the Water Board is false and not supported by toxicology, epidemiology, or any other discipline of health science. A toxicologist gave me an analogy on safety: he said if you were to stand at the guard rail at the Grand Canyon, you would be quite safe. Being five feet behind the guard rail may make you slightly safer. Five miles behind the guard rail does not “provide materially greater protection.”
Nowhere is there a statement that, without this new MCL, lives are at risk, because no lives are at risk.
There are no benefits to this new MCL. The Water Board fails to give an estimate of increased Quality-Adjusted Life Years (QALYs are used to measure an individual’s future longevity and the quality of the individual’s health during that time) were their proposal to be enacted. They assume that it will, absent any analysis.
Paying more for water, already safe under current rules, is not a benefit. There is no benefit to public health or safety, or to the people who would pay more for their water, or to the public water systems required to comply.
The supposed benefits rely on a circular argument on the Water Board’s part. The State Water Board simply assumes that a drinking water program that has lower limits would thus be “more protective of public health than the minimum federal requirements” and thus sets a lower public health goal, which then must be met because a drinking water program that has lower contaminant limits is “more protective of public health than the minimum federal requirements.”
For an example of analysis, according to a 1995 peer-reviewed study by Tamms et. al. , the Cost/Life-year for chlorination is $3100/Life-year, the Cost/Life-year for chlorination, filtration, and sedimentation is $4200/Life-year. Whereas tightening trichloroethylene control of 2.7 (versus 11) micrograms/liter is an eye-watering $37,000,000/Life-year.
Again, mere detection of a chemical in the environment cannot be equated with risk, but has to be evaluated in terms of the hazard, dose-response, and human exposure.
“The repeal of 22 CCR Chapter 12 resulted in the deletion of essential definitions that are referenced in other regulatory sections that were not repealed. Replacing the repealed definitions will clarify the current regulations, which will eliminate confusion by regulated entities.”
Heaven forbid, that you confuse regulated entities! Have you tried reading the bureaucratic argle-bargle you send to regulated entities? It is basically translates to: “we’re going to fine the pants off of you, if you don’t do whatever this says.”
IIII. SUMMARY OF PROPOSAL AND PURPOSE
“The primary purpose of the proposed regulations is to adopt a revised DLR of 0.002 mg/L for perchlorate to allow determination of perchlorate occurrence in drinking water sources at concentrations below the current DLR of 0.004 mg/L. This will allow determination of whether it is possible to amend the MCL for perchlorate, as required by HSC 116365.”
This is essentially a tautological argument for the existence of something unprovable: “Absence of evidence is not evidence of absence,” wrapped in the law (i.e., “as required by HSC 116365”). Science concerns itself with epidemiological and empirical evidence. And due to the studies, that have been conducted regarding perchlorate since the mid 1990s, there is less uncertainty that accompanies the establishment of a safe exposure level. Thus, the need for conservatism in the absence of knowledge has been replaced with data and knowledge, and doesn’t necessitate a lower DLR. In fact, the Environmental Protection Agency has determined that levels found in U.S. drinking water are so much NOT of concern, it has opted to not even set an MCL for perchlorates.
IV. NECESSITY OF PROPOSED REGULATIONS
“HSC subsections 116365(a) and (b) require the State Water Board to adopt primary drinking water standards for contaminants at levels as close as feasible to the corresponding PHGs, placing primary emphasis on the protection of public health, and to the extent that is technologically and economically feasible.” (emphasis mine) …. “The lack of data on perchlorate occurrence at concentrations below the current DLR hinders the State Water Board’s ability to evaluate whether technology achieves a materially greater protection of public health…”
This statement: “The lack of data on perchlorate occurrence at concentrations below the current DLR hinders the State Water Board’s ability to evaluate whether technology achieves a materially greater protection of public health…” is false. The State Water Board does not need that information as to whether such a number “achieves a materially greater protection of public health.” Safety is a matter of dosage. Dose makes the poison. And for perchlorate the RfD (Reference Dose, the safe exposure level for humans) has been studied extensively and is well known with uncertainty for infants accounted for. See Attachment “A” Perchlorate in Drinking Water, pages 22-27 “Assessing the Science Behind the RfD.”
Let me highlight one study in particular: “Crump et al. (2000) conducted a study of newborns (n=9784) and school-age children (n=162) from Chile (a region known for significant levels of perchlorate) to determine the effect of perchlorate in drinking water on thyroid function. …. The authors concluded that perchlorate in drinking water at concentrations as high as 100-120 microgram/L does not suppress thyroid function in newborns or school-age children.” So an amount magnitudes greater than the Water Board’s present MCL has no effect on newborns, yet the Water Board is worried that its present perchlorate MCL is too high and needs to be lowered? Please explain to a layperson, the Water Board’s safety concerns.
Dose determines risk. In the peer-reviewed paper on perchlorate cited above, the authors emphasized, “it is imperative that this cornerstone principle of toxicology be included in any assessment of perchlorate. Mere detection of a chemical in the environment cannot be equated with increased risk, but must be evaluated in terms of the hazard, dose-response, and human exposure, all steps in the characterization of health risk.”
This is not an academic exercise. This is required for you to make an informed decision.
As Frank Schnell, board-certified, PhD toxicologist (retired) explained Dose-Response to me, “Most biological effects, whether adverse or not, are the consequence of a cascade of biochemical reactions initiated when chemical agents (referred to by pharmacologists and toxicologists generically as ‘effectors,’ ‘agonists’ or ‘ligands’) bind to effect-specific macromolecular receptors usually distributed on cell surfaces. It is of supreme indifference to the receptor whether the chemical binding to it is of natural, synthetic, endogenous, or exogenous origin. As long as the ligand fits into the receptor’s active site, the “A sub-threshold concentration of the effector will not activate enough receptors to produce in the cell a significant effect.
“This receptor-mediated mechanism of action accounts for the existence of thresholds of effect and for the S-shaped Dose-Response Curve that typically results when the strength of the effect (from zero- to 100%-response) is plotted on the ordinate (y-axis) against the logarithm of the dose on the abscissa (x-axis).”
“A sub-threshold concentration of the effector” such as the dosages that the Water Board proposes “will not activate enough receptors to produce in the cell a significant effect. (If this were not the case, the effective regulation of normal metabolic processes would not be possible.)” In other words, very little does not do very little; it has no effect.
The federal Agency for Toxic Substances and Disease Registry (ATSDR) agrees. In its discussion of health effects of perchlorates, the ATSDR noted:
“In a study of the general population, Li et al. (2001) examined the prevalence of thyroid diseases in Nevada Counties with respect to perchlorate in drinking water. The cohort consisted of all users of the Nevada Medicaid program during the period of January 1, 1997 to December 31, 1998. Disease prevalence in residents from Clark County (Las Vegas), whose drinking water had 4–24 microgram/L of perchlorate (0.0001–0.0007 mg perchlorate/kg/day), were compared with those from another urban area of similar size (Reno, Washoe County), but with no perchlorate in the water, and also with those from all other counties, also with no perchlorate exposure…. Analysis of the data showed no statistically significant period-prevalence rate difference between Clark County and Washoe County. For acquired hypothyroidism, the prevalence was lower in Clark County than in other counties (opposite to what would be expected).”
“Several developmental studies of perchlorate in humans have focused on the evaluation of neonatal thyroid parameters. Lamm and Doemland (1999) examined rates of congenital hypothyroidism in seven counties of Nevada and California with perchlorate contamination in the drinking water (4–16 microgram /L [ppb]) (0.0001–0.0005 mg/kg/day). The investigators analyzed data from the neonatal screening programs of the two states for any increased incidence of congenital hypothyroidism in those counties. The rates for the California births were adjusted for Hispanic ethnicity, which was known to be a risk factor for congenital hypothyroidism. During 1996 and 1997, nearly 700,000 newborns were screened. The risk ratio in the seven counties was 1.0 (95% confidence interval [CI] 0.9–1.2) (249 cases observed/243 expected). The risk ratios for the individual counties relative to statewide expected rates ranged from 0.6 to 1.1. While the results showed no increase in rates of congenital hypothyroidism, it is known that congenital hypothyroidism is caused by developmental events that are not suspected of being affected by perchlorate exposure.
“Kelsh et al. (2003) also found no relationship between congenital hypothyroidism and exposure to perchlorate through the drinking water in a study of newborns (n=15,348) whose mothers resided in the community of Redlands, California, during the period 1983 through 1997 and who were screened by the California Newborn Screening Program. Perchlorate was detected in the water system serving the community at a concentration of up to 9 microgram /L (mean, <1 microgram/L).”
“Crump et al. (2000) conducted a study of school-age children from three cities with different concentrations of perchlorate in drinking water in northern Chile. The city with the highest perchlorate concentration was Taltal, 100–120 microgram perchlorate/L (ppb), water from the city of Chañaral had 5–7 microgram/L, and perchlorate was not detected in water from the city of Antofagasta. The study comprised 162 children 6–8 years of age, of which 127 had resided continuously in their respective city since conception. The children underwent examination of the thyroid gland and a blood sample was taken for analysis of TSH, T4, FTI, T3, and antiperoxidase antibody. After adjusting for sex, age, and urinary iodide excretion, the children from Taltal and Chañaral had slightly lower TSH levels than children from Antofagasta (opposite to expected), but the differences were not statistically significant.”
V. ECONOMIC IMPACT ASSESSMENT / ANALYSIS
“The proposed regulations are expected to benefit the health and welfare of California residents.”
Just as moving back from a guardrail at the Grand Canyon from ten feet to ten miles does not make someone safer, lowering the DLR or MCL for perchlorate does not make the water magically safer. Less of nothing to worry about is still nothing to worry about. Forcing people to spend money on an imagined benefit does make them poorer, and your ability to do that, while statutorily authorized, is theft. Who are you to say that you know better how to keep my customers safe? Yours, gentle members, is the tyranny of good intentions.
“Of all tyrannies,” C. S. Lewis wrote, “a tyranny sincerely exercised for the good of its victims may be the most oppressive…. This very kindness stings with intolerable insult. To be ‘cured’ against one’s will and cured of states which we may not regard as disease is to be put on a level of those who have not yet reached the age of reason or those who never will; to be classed with infants, imbeciles, and domestic animals.”
My customers own the public water system for which I work as the water master. They are also my friends and neighbors. Our rates are the cost of operation plus 5 percent for capital improvements divided by 24 which is the number of hookups. Despite our frugality and my modest salary, our rates are the highest in the county at $125 per month. This, for many of them, is a hardship. Tacking more onto their bill does not lessen that hardship.
I would rather my customers use their limited resources for their necessities, rather than a quixotic quest on the part of the Water Board.
VI. REASONABLE ALTERNATIVES CONSIDERED AND REJECTED
“No less burdensome and equally effective alternative has been proposed to the State Water Board for consideration.”
Let me suggest a less burdensome and equally effective alternative to the State Water Board for consideration: Do nothing. Unless your goal is to waste people’s money, and measure for lower levels of perchlorate simply because you can, then please consider doing nothing.
Another option would be for the Water Board to pay for this monitoring. Certainly, if this is about making people safer, the Water Board would be willing to fund it.
VII. PERFORMANCE STANDARD vs. PRESCRIPTIVE STANDARD
“The proposed regulation would impose a performance standard of 0.002 mg/L for the determination of perchlorate in drinking water.”
VIII. UNNECESSARY DUPLICATION WITH FEDERAL REGULATION
“There is no existing federal regulation addressing perchlorate in drinking water.”
No doubt the latest uproar caused by the Environmental Protection Agency declining to set an MCL for perchlorate has caused some consternation among the Water Board and staff. Yet, the Obama administration also declined to set an MCL. That should indicate to the Water Board and staff that there is no “there” there. We can’t blame the Trump Administration’s anti-environmental stance for failing to set an MCL when the Obama Administration also opted to simply follow the science and decline to make it an issue.
This also means that California has a stricter standard than the Federal one already. I realize that California prides itself on its strict environmental standards, but enough is enough already.
IX. TECHNICAL, THEORETICAL, OR EMPIRICAL STUDIES, REPORTS, OR SIMILAR DOCUMENTS RELIED UPON
The Initial Statement of Reasons lists no technical, theoretical, or empirical studies, reports, or similar documents regarding health or the life-years gained by the imposition of the new regulation.
In summary the Water Board has not done its due diligence to research and explain the need for a more restrictive Detection Limit for Purposes of Reporting (DLR). You must show us the data, research, scientific journal articles, or other scientific peer-reviewed articles that this new standard is “more protective of public health than the minimum federal requirements.” Otherwise you are unjustly requiring my customers to pay more for water that will not be safer or cleaner.
Mere detection of less of a chemical in the environment cannot be equated with decreased risk, but must be evaluated in terms of the hazard, dose-response, and human exposure, all steps in the characterization of health risk. No shortcuts. No special exemptions. Do the work.
Norman J. Benson, Licensed Water Master