Open Letter to California’s Water Board Regarding Perchlorate

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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.

III. BENEFITS

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).”

Dose-Response curve (log scale)

“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

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California’s State Water Board is gnawing on the perchlorate bone, again.

Chemaphobia thrives at California’s State Water Board.

California’s State Water Board hasn’t met a chemical it’s not afraid of.

The State Water Resources Control Board is accepting written public comments on proposed changes to the draft Perchlorate Detection Limit for Purposes of Reporting (DLR).
The public comment period ends on 7 August 2020, at 12:00 p.m. (noon).    

The Notice of Public Availability of Changes, proposed regulation text, and addendum to the Initial Statement of Reasons are attached and available at the following link: https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/perchlorate2.html
Information on how to submit written comments is available at the following link: https://www.waterboards.ca.gov/public_notices/comments/index.shtml
Additional information on perchlorate may be found at: https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/Perchlorate.html




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Bloomingcamp Ranch vs California’s Water Board

Bloomingcamp Ranch photo courtesy of Matthew Steinberg

I did more research. More contemplation. I reworked the letter to be less confrontational. More flies with honey than vinegar and all that… By the way should you wish to comment…

SUBMISSION OF WRITTEN COMMENTS. Persons interested in the draft order are encouraged to submit comments electronically. Comment letters must be received by 12:00 noon on June 22, 2020. Unless the State Water Board determines otherwise, comment letters received after the deadline will not be accepted. Send comments to Jeanine Townsend, Clerk to the State Water Board, by email at commentletters@waterboards.ca.gov (must be no more than 15 megabytes); fax at (916) 341-5620; or mail or hand delivery at:

Jeanine Townsend, Clerk to the Board
State Water Resources Control Board
P.O. Box 100, Sacramento, CA 95812-2000 (mail)
1001 I Street, 24th Floor, Sacramento, CA 95814 (hand delivery)

Please indicate in the subject line, “Comment Letter – Draft Order Bloomingcamp Water System”.

So here is my revised letter to the California Water Resources Control Board:

Jeanine Townsend, Clerk to the Board
State Water Resources Control Board
P.O. Box 100, Sacramento, CA 95812-2000

Re: Comment Letter – Draft Order Bloomingcamp Water System

It’s clear the California State Water Resources Control Board (SWRCB) cares very much about providing clean drinking water to the most vulnerable consumers, children.

Yet it seems a grave injustice to fine a family $13,508 (SWRCB 2020b) for water which, contains—in one liter of their water—the same amount of nitrate found in one four ounces [Ed. note: changed from one ounce to four ounces on 6/15/20 since EPA counts/weighs only the NO3 portion of nitrate] of iceberg lettuce. I propose the SWRCB accept the Bloomingcamp proposal to use bottled water. No one will become ill from drinking Bloomingcamp’s water, which I will show later. And their proposed solution to provide bottled water is more than adequate and thus no reason it cannot be a long-term solution.

This letter will discuss:

The SWCRB’s mandate with regard to drinking water

The SWCRB is mandated by California Water Code Section 106.3(a) which states:

  • It is hereby declared to be the established policy of the state that every human being has the right to safe, clean, affordable, and accessible water adequate for human consumption, cooking, and sanitary purposes. [emphasis added]

Section 106.3(b) then says all state agencies are to use this mandate where other state policies are to be considered.

(b) All relevant state agencies, including the department, the state board, and the State Department of Public Health, shall consider this state policy when revising, adopting, or establishing policies, regulations, and grant criteria when those policies, regulations, and criteria are pertinent to the uses of water described in this section.

(c) This section does not expand any obligation of the state to provide water or to require the expenditure of additional resources to develop water infrastructure beyond the obligations that may exist pursuant to subdivision (b).

(d) This section shall not apply to water supplies for new development.

(e) The implementation of this section shall not infringe on the rights or responsibilities of any public water system.

Prosecution of Duties for Public Health

During the summer of 2010, a “lady with a clipboard” approached Julie Murphy who was operating a lemonade stand at the monthly art fair in Northeast Portland and asked to see the city-issued restaurant license. Not aware she needed one, Julie was threatened with a $500 fine. The seven-year-old then burst into tears. Rules are rules. “Our role is to protect the public,” said Jon Kawaguchi, environmental health supervisor for the Multnomah County Health Department.

On July 17, 2014, a New York city plainclothes police officer confronted Eric Garner and accused him of selling “loosies” (single cigarettes), an illegal activity in the city. An officer placed Garner in a choke hold. Garner complained he could not breathe, but eventually lost consciousness. An ambulance was called but Garner was pronounced dead on arrival at the hospital.

The officers in both cases were enforcing rules ostensibly for the health of the public. Yet the actions by the officers, most observers would admit, were far beyond necessary. “On the opening day of law school, I always counsel my first-year students never to support a law they are not willing to kill to enforce,” Yale Law School’s Stephen L. Carter wrote in 2014 after New York City officers killed Eric Garner.(Tuccille 2020)

“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.”  

The draft order regarding Bloomingcamp Ranch’s water system is, by all indications, a case of “tyranny sincerely exercised for the good of its victims.” (Lewis 1970)

State Claims Nitrate is a Danger to Humans and Children in Particular

On May 4, 2018, the County of Stanislaus issued Compliance Order No. DER-18-R-008 (Compliance Order) to Bloomingcamp Ranch, a bakery and produce stand east of Modesto, which serves, according to California’s records, “6 residents, 4 employees, and 25 or more customers at least 60 days out of the year,” for violation of the maximum contaminant level (MCL) for nitrate found in the California Code of Regulations, Title 22, § 64431.

Among other things, the Compliance Order required Bloomingcamp to submit a Corrective Action Plan (CAP) “identifying improvements to the water system designed to correct the water quality problem,” which is a violation of the Maximum Contaminant Level (MCL) for nitrate, and to “ensure that Bloomingcamp delivers water to consumers that meets primary drinking water standards.” Bloomingcamp Ranch’s water contains slightly less than 2.5 times the MCL of nitrate (23.9 mg/liter versus the MCL of 10 mg/liter). (SWRCB 2020a) The Compliance Order also notified Bloomingcamp that the County was authorized to issue a monetary penalty if Bloomingcamp failed to correct the violation. (SWRCB 2020b)

The State claims critical public health reasons for addressing nitrate in water. Darrin Polhemus, a deputy director of the state board quoted in a Modesto Bee article, says the state’s vigilance regarding nitrates is due to the harm they can cause to infants with limited exposure. Specifically, nitrates interfere with the process of carrying oxygen in the bloodstream causing “blue baby syndrome” (methemoglobinemia).(Carlson 2019)

What Are Nitrate And Nitrite?

According to the United States Agency for Toxic Substances and Disease Registry (ATSDR), “Nitrate and nitrite are naturally occurring ionic species that are part of the earth’s nitrogen cycle. They typically exist in the environment in highly water-soluble forms, in association with other ionic species such as sodium and potassium. Nitrate and nitrite salts completely dissociate in aqueous environments. Nitrite is readily oxidized (combines with oxygen) to form nitrate. Nitrate is generally stable in the environment; however, it may be reduced to nitrite through biological processes involving plants, microbes, etc.

“In nature, plants utilize nitrate as an essential (key) nutrient.…Sodium nitrite is also being used in medicines and therapeutics; for example, as an antidote for cyanide poisoning and as a treatment for pulmonary arterial hypertension.” (Agency for Toxic Substances and Disease Registry 2015)

The present science literature on nitrates

It is odd that Mr. Polhemus and the State of California have not also prohibited sale of arugula, rhubarb, or vegetable soup since those have vastly higher levels of nitrate than the MCL allowed for water. There is no chemical difference between nitrate found in the water and nitrate found in foods. “Sodium nitrate is sodium nitrate,” says Josh Bloom, PhD, “no matter its source. The chemical is made in factories, in plants (the green kind), and by your body (more on that later) and the three are indistinguishable – identical in every way.”(Bloom 2019)

“The risk of methemoglobinemia among infants depends on many factors other than the ingestion of nitrate in drinking water,” write Ward et. al., in their report, ?Drinking water nitrate and human health. “Some foods and medications contain high levels of nitrate. Enteric infections, potentially caused by fecal bacteria contamination in wells, may lead to the endogenous production of nitrite, as evidenced by numerous published reports of infants with diarrhea and methemoglobinemia but no apparent exposure to exogenous MetHb-forming agents.” (Ward et al. 2005) Nitrates  and nitrites would be “MetHb-forming agents.” In the body, red blood cells use the hemoglobin protein to carry oxygen to the body. Methemoglobin (MetHb) is a form of hemoglobin protein that is not capable of binding oxygen and therefore does not deliver oxygen to the cells.

Furthermore, in a letter to ?Environmental Health Perspectives, Avery wrote, “This emphasis in the [?1949 American Public Health Association] survey and indeed the wide and rapid acceptance by the medical community that nitrates in drinking water are the primary cause of infantile methemoglobinemia have created an inherent bias: any methemoglobinemia case with elevated nitrates in the water is assumed to be caused by the nitrates, even though it is now clear that additional factors are critical for methemoglobinemia to occur. Furthermore, these factors have now been proven to cause severe methemoglobinemia without exposure to exogenous nitrates from water or food. Thus, the available evidence suggests that exogenous nitrates from drinking water have the potential to exacerbate, but not cause, methemoglobinemia.” (Alexander A Avery 2001)

Science as an evolutionary process

Science is not a fixed unyielding set of numbers and facts. It evolves as we learn more about our environment. “Science,” Jonathan Rauch writes, “is an open-ended, decentralized process for legitimizing belief. Much as creatures compete for food, so entrepreneurs compete for business, candidates for votes, and hypotheses for supporters. In biological evolution, no outcome is fixed or final—nor is it in capitalism, democracy, science. There is always another trade, another election, another hypothesis.” (Rauch 1999)

The hypothesis of a linkage between blue baby syndrome and nitrate began seventy years ago, after infants fed formula made with contaminated well water showed signs of methemoglobinemia. The effect was ascribed to the high nitrate content of these wells. This has since been disputed by Avery and others. (Alexander A Avery 2001)(Katan 2009)

The US Environmental Protection Agency (EPA), operating on a 1950’s hypothesis and an abundance of caution, set the MCL for nitrate of 44 mg/L (equal to 10 mg nitrate-nitrogen/L or 10 ppm).

Research has since pointed to fecal contamination of the well as the cause and not nitrate. By far, the major pollutant and the largest killer of people is by waterborne diseases. This is why chlorine, a known toxic chemical, is added to disinfect water.

In an experiment in 1948, in which infants who were fed 100 mg did not develop methemoglobinemia. When fed bacteria from contaminated wells, methemoglobinemia did develop. (Katan, 2009)

“Normal functioning of human vasculature requires both the presence of nitrite and nitric oxide…” and “Approximately 80% of dietary nitrates are derived from vegetable consumption; sources of nitrites include vegetables, fruit, and processed meats. Nitrites are produced endogenously through the oxidation of nitric oxide and through a reduction of nitrate by commensal bacteria in the mouth and gastrointestinal tract. As such, the dietary provision of nitrates and nitrites from vegetables and fruit may contribute to the blood pressure–lowering effects of the Dietary Approaches to Stop Hypertension (DASH) diet.” (Hord, Tang, and Bryan 2009)

It is not important where the nitrate comes from the chemical is the same. And the European Food Safety Administration notes, “Nitrate per se is relatively non-toxic…[and] recent researchindicates that nitrite participates in host defence having antimicrobial activity, and other nitrate metabolites e.g. nitric oxide, have important physiological roles such as vasoregulation. Despite being a major source of nitrate, increased consumption of vegetables is widely recommended because of their generally agreed beneficial effects for health.” (European Food Safety Authority, 2008)

It has long been known that methemoglobinemia occurs in infants less than 6 months of age without excessive intake of nitrates. “Protein intolerance accompanied by diarrhea and/or vomiting has also been proven to cause methemoglobinemia in infants less than 6 months of age without excessive intake of nitrates through food and water….Moreover, although over 90% of exogenous nitrate exposure comes from food, the only methemoglobinemia cases linked to food have involved high levels of nitrite contamination….All of these observations strengthen the view that endogenous nitrite production, not exogenous nitrate contamination of drinking water, is the primary cause of methemoglobinemia.” (Alexander Austin Avery 1999)

Nonetheless, the idea of a linkage between nitrate in the water and methemoglobinemia remains. “It appears that the biologically plausible hypothesis of nitrite toxicity (eg, methemoglobinemia) has essentially transformed a plausible hypothesis into sacrosanct dogma, despite the lack of proof.” (Hord, Tang, and Bryan 2009) Or as Mark Twain put it in Life on the Mississippi, “There is something fascinating about science. One gets such wholesale returns of conjecture out of such a trifling investment of fact.” (Twain 1883)

Nitrate levels found in food

Below are the amounts of nitrate found in common vegetables:

FoodNitrate concentration (mg/kg)Nitrate concentration (mg/oz)
Arugula4677131
Rhubarb294382
Mixed lettuce 206258
Butterhead lettuce 202657
Beet185252
Swiss chard169047
Curled lettuce 160145
Oak-leaf lettuce 153443
Belgian endive 146541
Lettuce132437
Romaine lettuce110531
Celery 110331
Fennel 102429
Kohlrabi98728
Iceberg lettuce87525
Dandelion 60517
Cole Slaw55916
Curly kale 53715
Radicchio35510
Leek 34510
Broccoli2798
Asparagus 2096
Vegetable Soup2096
Bloomingcamp well water1053
Sources: Nitrate in vegetables.  The EFSA Journal (2008) 689, 1-79  doi: 10.2903/j.efsa.2008.689; Food sources of nitrates and nitrites: the physiologic context for potential health benefits

As a friend of mine who has a PhD and has a background in chemistry, biochemistry, toxicology, and pharmacology, points out, fruits and vegetables contain a lot of nitrate but that is “swamped by endogenous production” (meaning what our bodies produce) which is “a source of nitric oxide – a critical signaling biomolecule with multiple functions throughout the body.” He told me you could use Bloomingcamp’s water to rinse your mouth out after eating a cucumber, if you wanted to lower your nitrate load.

FIGURE 1 A schematic diagram of the physiologic disposition of nitrate, nitrite, and nitric oxide from exogenous (dietary) and endogenous sources. The action of bacterial nitrate reductases on the tongue and mammalian enzymes that have nitrate reductase activity in tissues are noted by the number 1. Bacterial nitrate reductases are noted by the number 2. Mammalian enzymes with nitrite reductase activity are noted by the number 3.

© 2009 American Society for Nutrition

As a friend of mine who has a PhD and has a background in chemistry, biochemistry, toxicology, and pharmacology, points out, fruits and vegetables contain a lot of nitrate but that is “swamped by endogenous production” (meaning what our bodies produce) which is “a source of nitric oxide – a critical signaling biomolecule with multiple functions throughout the body.” He told me you could use Bloomingcamp’s water to rinse your mouth out after eating a cucumber, if you wanted to lower your nitrate load.

Figure 1  A schematic diagram of the physiologic disposition of nitrate, nitrite, and nitric oxide from exogenous (dietary) and endogenous sources. The action of bacterial nitrate reductases on the tongue and mammalian enzymes that have nitrate reductase

The importance of dose

As I sit at my laptop composing this letter, I am sipping a phenol-laced liquid containing 826 volatile chemical substances, 16 of which are known by the State of California to cause cancer including: acrylamide, caffeic acid, catechol, furfural, and hydroquinone. (Ames, 1990) I put a little cream in it, since the insecticide in the drink, caffeine, is rather bitter. Caffeine by the way is comparably toxic as another SWRCB concern: chromium-6.

Caffeine’s LOAEL (Lowest Observed Adverse Effect Level) of 2.5 mg/kg-day is quite close to that of chromium-6. Toxicologists then calculate a Reference Dose (RfD) from the LOAEL. Dr. Tamara L. Sorell writes, “The final RfD [for caffeine] would be 0.0025 mg/kg-day, a very small dose in the same range as RfDs for known toxicants such as hexavalent chromium [chromium-6] and potassium cyanide.” (Sorell, 2016) A quick back-of-the-envelope calculation says one drop of coffee is roughly 270 times above the “safe” level for consumption. Maybe I should put that drop in a gallon of water to be safe?

Every substance we interact with, no matter how dangerous, has a level at which it is benign; and every substance, no matter how benign, has a level at which it is toxic. Or as Paracelsus (1493-1541) put it, “All substances are poisons; there is none which is not a poison. The right dose differentiates a poison and a remedy.”

As an example: Which of these substances is the least toxic: arsenic, cyanide or vitamin D?

Answer: Of the three, arsenic is the least toxic. Vitamin D and cyanide are identically as lethal. It takes 50 percent more arsenic to kill someone than vitamin D. (National Science Teachers Association n.d.)

The Dose-Response curve

Since dose determines risk, the Dose-Response of the body is critically important. “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,” the American Council on Science and Health emphasized in a peer-reviewed paper on perchlorate (the principle will be the same with nitrates and nitrites). (Daland Juberg and Stier 2002)

As Frank Schnell, board-certified, PhD toxicologist (retired) explains Dose-Response, “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 former will produce the effect mediated by that receptor.

“This receptor-mediated mechanism of action accounts for the existence of thresholds of effect and for the S-shaped Dose-Response (D-R) 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).”

Figure 2 Dose-Response Sigmoid Curve

Now, here’s the kicker, Schnell writes that “A sub-threshold concentration of the effector 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.)” (emphasis added). In other words, very little does nothing.

The Unbearable Lightness of Wallet

Since SWRCB’s mandate says people must have affordable water—and in the case of Bloomingcamp water company, the operators are also the paying customers—SWRCB must weigh the cost of caution against the safety (usually given as life-years) it provides. This is not a mere academic exercise; capital is limited resource, once spent for one priority it is not available to spend on another. “Policymakers are used to considering the regulatory environment one regulation at a time from the perspective of the regulator and with a parochial view of their agency as the only relevant player in the field,” wrote Boden, et. al., “This perspective too often ignores the viewpoint of a person starting a business, who must comply with regulations at multiple levels of government across overlapping issues. To these entrepreneurs, the regulatory thicket offers negligible benefits when compared to the added compliance burden.” This “regulatory thicket” “imposes real costs on real people.”(Boden et al. 2019) The Mercatus Center at George Mason University, puts the amount of money lost since 1980, due to added federal regulation alone, at $4 trillion; a drag of 25 percent on the economy. “If regulation had been held constant at levels observed in 1980, the US economy would have been about 25 percent larger than it actually was as of 2012….This amounts to a loss of approximately $13,000 per capita, a significant amount of money for most American workers.” (Coffey, 2016)

What is worse, regulations, with health in mind, may increase mortality. “[M]any regulations result in unintended consequences that increase mortality risk in various ways. These adverse repercussions are often the result of regulatory impacts that compete with the intended goal of the regulation, or they are direct behavioral responses to regulation.” (Viscusi, 2017)

Of course, economics alone should not guide us in decision making. But as Bjorn Lomborg reminds us, “[I]gnoring costs doesn’t make difficult choices disappear; it makes them less clear.” (Specter, 2015)

When we spend money on the wrong priorities, that money is not available for things that could truly save lives. As Frank Schnell told me, “In real life, excess conservatism doesn’t just waste money; it also costs lives, i.e., the ones that could have been saved had the wasted money been spent more wisely.” (Schnell, 2016)

Summary of the Science

  • In addition to what we eat or drink, our bodies biosynthesize nitrates and nitrites in greater quantities than they get from ingesting foods and we get many of those from eating vegetables and, to a lesser extent, meat. This production by our bodies provides a source of nitric oxide – a critical signaling biomolecule with multiple functions throughout the body. (Bloom, 2019)
  • Researchers are quite divided on whether nitrate alone causes methemoglobinemia in infants.
  • Dose makes the poison.
  • Regulations may be a poor way of providing public health.

But what about the law? The law, after all, is the law.

Discretion of officers, prosecutors, judges, and juries in matters of law

Under California’s progressive system, the responsible regulatory agency writes regulations to flesh out legislation. These regulations then become the law. The regulatory agency then acts as cop, judge, jury, and jailer for the laws they have written. (Leonard, 2015) Officers have discretion. Prosecutors have discretion. Juries have discretion. Jury trials were so important to this country’s founders it is listed in our Constitution three times.

Granted, the low MCL for nitrate is a federal requirement that is beyond the Board’s purview. Yet in its draft “Order Denying Petitions For Reconsideration” the water board uses their rules, regulations, and administrative jargon as a shield.

It is the myopia of adjudicating the infraction and not seeing and treating people as people that harms us all. The State ought to provide clear and convincing evidence of harm, not of an infraction of a rule. Bloomingcamp’s proposals are rational, and since their solution will provide safe drinking water to guests, common sense should prevail. Your hands are not tied.

Henry David Thoreau believed that a person must disobey bad laws as a matter of conscience. Was it justice for the law to return escaped slaves to their masters? After all, slaves were property. “Must the citizen ever for a moment,” Thoreau pondered, “or in the least degree, resign his conscience to the legislator? Why has every man a conscience, then? I think that we should be men first, and subjects afterward.” (Thoreau 1848)

It is up to you to do the right thing; Thoreau, no doubt, would.

Potential courses of action

  • Bloomingcamp Ranch could do a “jingle mail drop” and turn the running of the system to the State of California. Of course, the authorities would then operate the Bloomingcamp well and put a lien on the property, but little beyond that.
  • Water Board passes an order to force Bloomingcamp Ranch spend $300,000 to fix the “problem.”
  • Water Board accepts Bloomingcamp Ranch proposal to use bottled water at the bakery and place “Non-Potable Water” signs at faucets. Signs in restrooms, I believe, is what is done at Modesto Airport. Such signs provide the public with information and indicates this has worked in a place with presumably more consumers than a bakery and cider house. It should work at Bloomingcamp too.

My recommended action

Water Board accept Bloomingcamp Ranch proposal to use bottled water at the bakery. No one will become ill from drinking bottled water (and, face it, without the bakery, the water system can be classed as private and it’s then none of the Water Board’s business). Or, at long last, does no sense of decency remain in your souls?

Thank you for this opportunity to comment on this important consideration.

Norman Benson

References

Agency for Toxic Substances and Disease Registry. 2015. “Toxicological Profile: Nitrate and Nitrite.” U.S. Department of Health and Human Services. http://www.atsdr.cdc.gov/toxprofiles/TP.asp?id=1452&tid=258.

Avery, Alexander A. 2001. “Correspondence – Cause of Methemoglobinemia: Illness versus Nitrate Exposure.” Environmental Health Perspectives 109 (1). http://www.nlm.nih.gov.

Avery, Alexander Austin. 1999. “Infantile Methemoglobinemia: Reexamining the Role of Drinking Water Nitrates.” Environmental Health Perspectives 107 (7): 583–86. https://doi.org/10.1289/ehp.99107583.

Bloom, Josh. 2019. “Whole Foods Sells Both ‘Nitrate-Free Meat’ and Nitrate Supplements. Yup. | American Council on Science and Health.” American Council on Science and Health. 2019. https://www.acsh.org/news/2019/10/16/whole-foods-sells-both-nitrate-free-meat-and-nitrate-supplements-yup-14334.

Boden, Anastasia, Braden Boucek, Paul Larkin, Clark Neily, Jonathan Riches, Lawrence Vandyke, and Luke Wake. 2019. “Managing the Regulatory Thicket: Cumulative Burdens of State and Local Regulation State and Local.” https://regproject.org/wp-content/uploads/RTP-State-and-Local-Working-Group-Paper-Regulatory-Thicket.pdf.

Carlson, Ken. 2019. “Stanislaus County CA Fruit Stand Has Water Problems | Modesto Bee.” Modesto Bee. 2019. https://www.modbee.com/news/business/agriculture/article229379199.html.

Daland Juberg, by R, and Jeff Stier. 2002. “Perchlorate in Drinking Water Scientific Collaboration in Defining Safety.” https://www.acsh.org/wp-content/uploads/2012/05/20040405_perchlorate2002.pdf.

Hord, Norman G, Yaoping Tang, and Nathan S Bryan. 2009. “Food Sources of Nitrates and Nitrites: The Physiologic Context for Potential Health Benefits.” The American Journal of Clinical Nutrition 90 (1): 1–10. https://doi.org/10.3945/ajcn.2008.27131.

Katan, Martijn B. 2009. “Nitrate in Foods: Harmful or Healthy?” American Journal of Clinical Nutrition 90 (1): 11–12. https://doi.org/10.3945/ajcn.2009.28014.

Lewis, C S. 1970. “GOD IN THE DOCK ESSAYS ON THEOLOGY AND ETHICS.”

National Science Teachers Association. n.d. “ASSESSING TOXIC RISK: STUDENT EDITION.” In . Accessed September 30, 2016. http://ei.cornell.edu/teacher/pdf/ATR/ATR_Chapter1_X.pdf.

Rauch, Jonathan. 1999. Kindly Inquisitors: The New Attacks on Free Thought, Expanded Edition.

SWRCB. 2020a. “CA Drinking Water Watch: NEW WELL 01 (5000435-002).” State Water Resources Control Board. 2020.

SWRCB. 2020b. “D R A F T In the Matter of the Petitions for Reconsideration By.” https://www.waterboards.ca.gov/public_notices/comments/docs/draftorder_bloomingcamp_051820.pdf.

Thoreau, Henry David. 1848. “Civil Disobedience.” Civil Disobedience. https://thoreau.thefreelibrary.com/Civil-Disobedience.

Tuccille, J. D. 2020. “Riots May Be Destructive, but Abusive Policing Is Tyranny – Reason.Com.” Reason.Com. 2020. https://reason.com/2020/06/01/riots-may-be-destructive-but-abusive-policing-is-tyranny/.

Twain, Mark. 1883. Life On The Mississippi. Boston: James R. Osgood and Company. https://www.gutenberg.org/files/245/245-h/245-h.htm.

Ward, Mary H., Theo M. deKok, Patrick Levallois, Jean Brender, Gabriel Gulis, Bernard T. Nolan, and James VanDerslice. 2005. “Workgroup Report: Drinking-Water Nitrate and Health – Recent Findings and Research Needs.” Environmental Health Perspectives 113 (11): 1607–14. https://doi.org/10.1289/ehp.8043.

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