September 13, 2010
Governor Chris Gregroir
Office of the Governor
PO Box 40002
Olympia, WA 98504-0002
Fluoride Class Action Amicus Letter in Support of Rulemaking Appeal by Washington Action for Save Water
Click on https://www.fluoride-class-action.com/bd-of-health/amicus-letter to read this letter online.
Click on https://www.fluoride-class-action.com/bd-of-health/amicus-letter/amicus-letter-doc to download this letter.
Dear Governor Gregroir,
On June 9, 2010, Washington Action for Safe Water (WASW) petitioned the Board of Health to change its rules regarding fluoridation materials added to drinking water. The Board denied the petition. Washington Action for Safe Water appealed the denial.
I am writing to you as president of Fluoride-Class-Action to support the appeal Washington Action for Safe Water sent you. Fluoride-Class-Action is a separate group from Washington Action for Safe Water, and Washington Action for Safe Water has not approved and does not necessarily take the same positions as Fluoride-Class-Action. This is an “amicus letter,” analogous to an “amicus brief.”
The purpose of Fluoride Class Action is to assist personal injury, and toxic tort attorneys in bringing suit against water districts and state agencies for the harms caused by drinking water fluoridation. Another purpose is to warn water districts and state agencies that fluoridation suits are coming.
Washington Action for Safe Water proposed new rules because the silicofluorides used by the water districts in Washington to fluoridate, and which are approved for use by the Board of Health, are not approved by the FDA, the EPA, the CDC, the Washington Department of Health, the Washington Board of Pharmacy, or by any other federal or state agency.
Instead silicofluorides, a term that includes fluorosilicic acid and sodium hexafluorosilicate, are approved by a trade association called the National Sanitation Foundation (NSF). NSF is controlled in part by the chemical industries which use and produce fluoride. We believe NSF certification to be invalid and in fact fraudulent.
The Board of Health’s Environmental Health Committee (EHC) came to the June 9 meeting with its analysis and recommended decision written up. Below I will go point-by-point through the EHC’s analysis and recommended decision.
The EHC read its recommended decision – that the WASW proposed rule be denied. Board members quickly voted unanimously in favor of the EHC. It appeared that many of the board members had not even read the materials in advance. Only after the Board had rubber stamped the EHC recommendation were members of WASW allowed to speak. At minimum this practice creates the appearance of impropriety. The Board of Health and EHC staff should at least pretend to consider oral comments.
Simply stated, the WASW proposal would call for the Board of Health to enact a rule that would require those water districts which choose to fluoridate to do so using only pharmaceutical grade fluoride.
Further, the WASW proposal would call for the Board of Health to require those water districts which choose to fluoridate to do so only using fluoridation materials which have been approved by a genuine government agency.
Because the diluted fluoride-water mixture is intended to prevent or treat disease, it meets the definition of a “drug” and because it is used in interstate commerce, its regulation would logically fall to the FDA. Fluoride-Class-Action would be equally happy if any federal or state agency would test, certify, and regulate fluoridation materials. However, the FDA by law clearly does have jurisdiction over public water fluoridation. Thus WASW wrote its rulemaking proposal to say that fluoridation should be carried out only with fluoridation materials approved by the FDA. Substitute “any authorized federal or state agency” if you prefer.
The FDA, for apparently political reasons, is afraid to assert jurisdiction over the issue of adding fluoride to public drinking water. It is not known if some silicofluoride producer has ever applied for FDA approval of silicofluoride fluoridation materials for public water fluoridation. However, it is known that the FDA has never approved SiF fluoridation materials for public water fluoridation.
Publicly, the FDA has been strangely silent on the issue of drinking water fluoridation. Behind the scenes, however, the FDA has played fluoride hotball with the EPA. In 1978 the FDA and the EPA worked out a Memorandum of Understanding. In that Memorandum the FDA stated that it was assigning all its authority to regulate drinking water fluoridation to the EPA. However, such assignment was not legal. The terms of the Memorandum violate jurisdictional aspects of the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Safe Drinking Water Act (SDWA). The EPA and the FDA did not obtain Congressional approval of their Memorandum, neither before nor after it went into effect.
The silicofluorides that Seattle and Everett buy, along with most other high capacity water districts, are produced in super-phosphate fertilizer plants, mainly in Florida and Louisiana, but also in China and other countries. Phosphate rock and sulfuric acid are cooked together. The fumes go up the stack. Before 1979 the smoke escaped to poison the surrounding countryside, killing plants, animals, and people. Today that smoke is captured in wet scrubbers built into the smokestacks. The liquid which captures the smoke is called “scrubber liquor.” Unfiltered and unrefined, scrubber liquor is pumped into tanker trucks and delivered to the headwaters of our rivers where it is discharged into our drinking water.
Toxic material which is illegal to discharge into air is captured in scrubber liquor, which is illegal to discharge into lakes, rivers, or seas, but which can be discharged into our drinking water. It is absurd when you think about it.
Nothing good can be said about the super-phosphate fertilizer industry. Only 30 percent of super-phosphate fertilizer applied to corn, soy, wheat, or cotton is absorbed by plants. The remaining 70 percent builds up in the soil and stunts microbial life. Sufficient phosphate is present in most soils; pH only need be adjusted to between 5.5 and 7.0 to make it available. If soil is deficient in phosphorus, the way to add it is the way organic farmers add it: to mix raw phosphate rock with animal or vegetable manure and compost it. Organic phosphate is long lasting and keeps soil healthy for microbes.
Super-phosphate fertilizer plants are surrounded by miles of toxic waste “gypsum stacks.” Gypsum stacks can be a hundred feet high. They encircle evaporation ponds which contain vast quantities of scrubber liquor. Scrubber liquor dries and hardens into white pebbles, which are dredged out of the ponds into the surrounding gypsum stacks. These silicofluorides are unusable in industry because the silicon is hard to remove. The pebbles cannot be used to gravel roads because they are radioactive. If the companies which build these giant piles were required to clean them up or restore the land, the companies would immediately be bankrupt. Such a task would be impossible. These are permanent sacrifice zones. The super-phosphate industry is unnecessary and destructive.
When fluoridation began in the 1940s only sodium fluoride was used. All early fluoridation tests on humans and animals were done and have almost always been done using pharmaceutical grade sodium fluoride. Although neither type of fluoridation material is safe for internal consumption, there are clear indications that silicofluorides are worse than sodium fluoride.
Currently no federal or state agency tests or approves the silicofluoride which is currently used by Seattle and by 92% of the water districts in the country which practice water fluoridation.
The fluoride debate creates cognitive dissonance. One who has heard all his life that fluoride is both helpful and harmless comes to accept this as a belief that is hard to let go of.
For a politician the dissonance is especially great because coming out against fluoridation can arouse opposition. Dental groups bring to bear time, money, and credibility and use it to support friends of fluoridation and oppose its enemies. They are well organized and well funded.
The fluoride debate is confusing. One key to understanding it is this: There are two reasons why fluoridationists support fluoridation. First, there is the overt reason: Fluoridationists apparently believe sincerely that fluoride is good for teeth, although they do not seem to be aware of or care about its effect on the rest of the body. Second, there is the less obvious reason: Adding fluoride to drinking water is a way to dispose of an estimated 200,000 tons of toxic waste per year – avoiding cost of disposal and even turning a profit. It is illegal to dump fluoride into rivers or oceans, but it is can be poured into our drinking water at 1.0 ppm. Rebecca Hanmer, Deputy EPA Assistant Administrator for Water, admitted the two reasons in 1983.
The only valid reason for adding fluoride to water is to prevent tooth decay, and if it does not do that or if it causes harmful side effects in some or all, it should not be added. Fertilizer manufacturers can find some other way to dispose of their toxic waste and some other way to get rich.
I now turn to EHC’s written recommendation. The first two conclusions reached by the Environmental Health Committee (EHC) and presented at the June 9 meeting were:
1) EPA is the lead federal agency for regulating the maximum levels of contaminants and additives in tap water under the Safe Drinking Water Act.
2) FDA has relinquished any authority it might have for regulating fluoride levels in tap water under the memorandum of understanding with EPA.”
The writer completely misunderstands the relationship between the EPA, FDA, NSF, and the legal significance of the FFDCA and the SDWA.
As stated above, there is no federal or state agency which tests or approves the type of fluoride we put in our drinking water. However, fluoride is tested, approved, and certified safe by the National Sanitation Foundation, otherwise known as NSF International or just NSF. What then is NSF?
NSF is a private trade organization which is controlled in part by corporations which use and produce fluoride and other chemicals. Disposal of leftover fluoride is a costly problem for fertilizer, aluminum, steel, uranium, steel, gasoline refining, and other industries. Turning fluoride into a decay fighting tonic has saved chemical corporations a lot of money and even made them a profit.
NSF appears to be reputable and gives silicofluorides a “NSF Standard 60 Approved” stamp, which water districts in 47 states are required by law to conform to.
Should fluoridation materials be tested and approved by a federal or state agency? Who should approve and regulate fluoride? The CDC? The EPA? The FDA? State boards of health or state boards of pharmacy? Is it acceptable to privatize the regulation of such chemicals and turn the approval process over to a trade association which is subject to undue influence by the chemical industry?
How did NSF come to wield such power? It is a fascinating story and Christopher Bryson has told it well in his masterful book, Fluoride Deception, a copy of which we are sending you.
The Centers for Disease Control (CDC), an agency within the Public Health Service, is the biggest cheerleader for drinking water fluoridation in the United States. See http://www.cdc.gov/fluoridation. However, the CDC has no jurisdiction over water fluoridation.
I know of no surgeon general who has not been a proponent of fluoridation. However, the Surgeon General too has no jurisdiction over water fluoridation.
What about the EPA? The EPA, an agency separate and apart from the Public Health service, is also a big cheerleader for water fluoridation. The Safe Water Drinking Act (SDWA) is administered by and regulates the actions of the EPA in connection with drinking water. Note that the SDWA specifically states at 42 USC 300g-1(b)(11):
No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.
The EPA may require that contaminants be removed if they exceed MCL maximum contaminant levels. For fluoride the MCL is 4 ppm. The EPA may require the addition of substances to water, but only substances which remove or control contaminants.
The EPA could not itself regulate fluoridation but was still eager to promote fluoridation, so it trained the NSF in how to regulate water fluoridation and then assigned its apparent authority over water fluoridation to the NSF. But the EPA as well has no jurisdiction over water fluoridation and no authority to transfer regulatory authority to NSF or any organization.
Substances “for preventive health care purposes unrelated to contamination of drinking water” may not be added. That would include drugs and medicine. Fluoride mixed with water at 1 ppm meets federal and state definitions of “drug” and “medication.” This is because fluoride is added to prevent or treat disease.
So it comes as a big surprise to those who delve into this highly convoluted area of history, law, and back room politics to learn that the EPA as administrator of the SDWA regulates only the removal of contaminants which naturally appear in water or which have been added through pollution. It does not authorize adding chemicals except for chemicals which deal with contaminants. Thus, fluoride does not fit within the EPA’s purview.
EPA scientists have generally opposed fluoridation, but EPA administrators, who are often not scientists, have generally supported it, for example by empowering the NSF to authorize fluoridation, as discussed below. EPA scientists have been able to speak out, only because they are protected by a strong union. Agencies like the EPA, FDA, and CDC are like small nations. They are controlled by managers who have worked for and taken money from and will work again for and take money from the big chemical corporations which the agencies regulate.
Many think that because the SDWA has a 4 ppm maximum contaminant level (MCL) for fluoride, that the SDWA authorizes the addition of fluoride up to a 4 ppm maximum. This is not so. The SDWA only requires removal of fluoride if it exceeds 4 ppm. The 2006 NRC Report Summary at page 1 clarifies this:
In 1986, EPA established an MCLG [maximum contaminant level goal] and MCL [maximum contaminant level] for fluoride at a concentration of 4 milligrams per liter (mg/L) and an SMCL [special contaminant level to prevent excessive fluorosis] of 2 mg/L. These guidelines are restrictions on the total amount of fluoride allowed in drinking water. … EPA’s drinking-water guidelines are not recommendations about adding fluoride to drinking water to protect the public from dental caries. … Instead, EPA’s guidelines are maximum allowable concentrations in drinking water intended to prevent toxic or other adverse effects that could result from exposure to fluoride.
In each state there is a lead agency which is empowered to administer the SDWA, and in Washington that agency is the Department of Health. RCW 70.119A.080, RCW 43.21A.445. The EPA has granted primacy to the state of Washington to implement the SDWA. See 40 CFR 42.10. In RCW 43.21A.445 several Washington agencies led by the Department of Health are “… authorized to participate fully in and are empowered to administer …” the SDWA.
Because the SDWA prohibits any “national primary drinking water regulation” from requiring “the addition of any substance for preventive health care purposes” and because the SDWA requires that state “… drinking water regulations” be “no less stringent than the national primary drinking water regulations,” Washington regulations likewise must be so limited. Therefore, the Department of Health may not require municipalities to add fluoride or any other medication intended for “preventive health care purposes.”
Instead the Department of Health allows municipalities to fluoridate provided they use fluoridation materials which meet NSF 60 standards. The Department of Health requires the use of a certain type of fluoridation and a certain concentration of fluoride, between .8 ppm and 1.3 ppm, if a municipality makes the final decision to fluoridate. We would contend that there is a fine line between what the Department of Health is doing and a violation of the SDWA.
The FDA defers to the EPA which defers to NSF, which certifies fluoridation materials a safe, which inspires the Washington Department of Health to defer the decision to fluoridate to water departments.
This limitation on “the addition of any substance for preventive health care purposes” flows down to the states, but does it flow down further to municipalities? 40 CFR 142.3 provides:
… [T]his part [40 CFR Part 142—National Primary Drinking Water Regulations Implementation] applies to each public water system in each State.
40 CFR 142.2 defines a “public water system” thus:
Public water system or PWS means a system for the provision to the public of water for human consumption through pipes or, after August 5, 1998, other constructed conveyances, if such system has at least fifteen service connections or regularly serves an average of at least twenty-five individuals daily at least 60 days out of the year.
Using the wording of this federal regulation, it would appear that a city council which votes to fluoridate is enacting a “drinking water regulation” which requires “the addition of” a “substance for preventive health care purposes unrelated to contamination of drinking water,” namely fluoride. If the limitations imposed by the SDWA do flow down to the City, then a decision by a city or water district to fluoridate is contrary to federal law because it violates the SDWA, and contrary to state law because state law incorporates and should enforce federal law.
The Food, Drug, and Cosmetics Act (FDCA) defines a drug as an article
… intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal. 21 USC 321 (g)(1)(B).
Dental caries is a disease. Fluoride is added to water to prevent caries. Therefore fluoride is a drug. Because fluoridated water is a drug, the US Food and Drug Administration (FDA) should have jurisdiction over fluoride added to drinking water.
However, the FDA has chosen not to assert jurisdiction over fluoride scrubber liquor in its raw state nor over the fluoride-tap water drug mixture called fluoridated water. The FDA has asserted jurisdiction over toothpaste and mouthwash, which are not to be swallowed, even in a pea-size amount. The Oral Health Division of the FDA has asserted limited jurisdiction over fluoridated bottled water. See Appendix D-37. But the FDA has not asserted jurisdiction over the fluoridated tap water drug.
It was in 1974 that 42 USC 300g-1(b)(11) was added to the SDWA. Recall that this section of the SWDA specifically forbade the EPA from requiring
the addition to drinking water of any substance for preventive health care purposes unrelated to contamination of drinking water.
However, in 1979 the FDA and the EPA entered into an inter-agency treaty, a Memorandum of Understanding, numbered MOU 225-79-2001. This Memorandum included these provisions;
[There is] the possibility of overlapping jurisdiction between EPA and FDA with respect to control of drinking water additives has been the subject of Congressional as well as public concern. … [T]he authority to control the use and application of direct and indirect additives to and substances in drinking water should be vested in a single regulatory agency to avoid duplicative and inconsistent regulation. … [The] EPA has been mandated by Congress under the Safe Drinking Water Act (SDWA), as amended, to assure that the public is provided with safe drinking water. … [The] FDA has been mandated by Congress under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, to protect the public from, inter alia, the adulteration of food by food additives and poisonous and deleterious substances. … [The] EPA will have responsibility for direct and indirect additives to and other substances in drinking water under the SDWA … and [the] FDA will have responsibility for water, and substances in water, used in food and for food processing and responsibility for bottled drinking water under the FFDCA. … In the past, FDA has considered drinking water to be a food under Section 201(f). However, both parties have determined that the passage of the SDWA in 1974 implicitly repealed FDA’s authority under the FFDCA over water used for drinking water purposes. Under the express provisions of Section 410 of the FFDCA, FDA retains authority over bottled drinking water. Furthermore, all water used in food remains a food and subject to the provisions of the FFDCA. Water used for food processing is subject to applicable provisions of FFDCA. Moreover, all substances in water used in food are added substances subject to the provisions of the FFDCA, but no substances added to a public drinking water system before the water enters a food processing establishment will be considered a food additive. … The expressed intent of the [SWDA] was to give EPA exclusive control over the safety of public water supplies. … EPA’s responsibilities are … [t]o establish appropriate regulations, and to take appropriate measures, under the SDWA …, to control direct additives to drinking water (which encompass any substances purposely added to the water), and indirect additives (which encompass any substance which might leach …). FDA’s responsibilities are [t]o take appropriate regulatory action under the authority of the FFDCA to control bottled drinking water and water, and substances in water, used in food and for food processing; [t]o provide assistance to EPA to facilitate the transition of responsibilities, including: … [t]o review existing FDA approvals in order to identify their applicability to additives in drinking water…; [t]o provide a senior toxicologist to help EPA devise new procedures and protocols to be used in formulating advice on direct and indirect additives to drinking water. … EPA’s responsibilities are as follows: … [t]o establish appropriate regulations, and to take appropriate measures, under the SDWA … to control direct additives to drinking water (which encompass any substances purposely added to the water), and indirect additives (which encompass any substance which might leach …). [emphasis added]
Note that the agencies agreed that the FDA would
… control bottled drinking water and water, and substances in water, used in food and for food processing….
Note that the EPA would
“… take appropriate measures, under the SDWA … to control direct additives to drinking water (which encompass any substances purposely added to the water).
Here the EPA is asserting authority over all additives “purposely added.” This language would include fluoridation materials. Thus, the Memorandum of Understanding violates the plain language of the SDWA.
There were and are problems with this deal. First, only Congress can change a federal statute. An agency cannot decline authority Congress has given it and cede that authority to another agency. Nor can the other agency assume a responsibility it was not granted by Congress, particularly when the agency is barred from receiving it. This is clearly what the FDA and EPA pretended they were doing.
The net result was that the FDA was unwilling to regulate water fluoridation, apparently because fluoride was a political hot potato, and the EPA was legally barred from regulating water fluoridation, although the Memorandum of Understanding made it appear that the EPA could do so.
In 1985 the EPA assigned to a trade association known as NSF the EPA’s authority to write regulations governing the addition of fluoride to drinking water. The EPA assigned powers it did not have and did not have authority to assign. Congress sets up agencies. Agencies do not set up sub-agencies.
Who or what is NSF? See the July 7, 2000, letter which Stan Hazan, then NSF general manager, wrote to Rep. Ken Calvert:
NSF involvement in the evaluation of drinking water chemicals, including fluoride-based chemicals, began in 1985, when the U.S. EPA granted an NSF-led consortium of stakeholders the responsibility to develop consensus, health-based, quality specifications for drinking water treatment chemicals and drinking water system components. [emphasis added]
NSF proceeded to construct the NSF Standard 60 rule. The “NSF 60” logo is stamped on every fluoride shipment bill of lading. The Hazan letter continues:
“NSF 60 Drinking Water Treatment Chemicals – Health Effects” was initially adopted in December 1987, and was last revised in May 2000. The standard was developed using a consensus standards development process with representation of the major stakeholder interests, including product manufacturers [emphasis added]….
So the industries which produce fluoridation materials are on the board which develops the standards that regulate them.
NSF says in its Standard 60 Product Information Form: “NSF … will perform required testing for performance and health effects.” Vendors are required to provide to NSF “a supplier specific material safety data sheet (MSDS) or similar information for each raw material … and a Certificate of Analysis (C of A) for each raw material in the formulation.”
See a typical National Institute of Standards and Technology certificate of analysis. See the typical contents of a certificate of analysis.
The February 2008 NSF Fact Sheet on Fluoridation Chemicals says:
The NSF Joint Committee … consists of … product manufacturing representatives. … Standard 60 … requires a toxicology review to determine that the product is safe at its maximum use level and to evaluate potential contaminants in the product. … A toxicology evaluation of test results is required to determine if any contaminant concentrations have the potential to cause adverse human health effects. … NSF also requires annual testing and toxicological evaluation …. The NSF standard requires … toxicological evaluation.
However, in his letter to Representative Calvert, Hazan contradicts the 2008 NSF Fact Sheet. Hazan says:
The standard requires that the manufacturer of a product submitted for certification provide toxicological information, if available. NSF requires that manufacturers seeking certification to the standard submit this information as part of their formulation or ingredient supplier submission. … [emphasis added]
The implication is that the manufacturers of fluoridation materials did not have toxicological studies available and so NSF did not receive any. The language appears to require NSF to provide toxicological studies if fluoride manufacturers fail to provide them.
It is hard to prove something does not exist, but there is substantial evidence that NSF has no toxicological studies. First, there are no toxicological studies on fluoride on the extensive NSF web site at www.NSF.org. Blake Stark is the person at NSF International now in charge of fielding questions regarding Standard 60. Call Blake at 734-769-5480 or email him at Stark@NSF.org and ask him if there are any toxicological studies. Blake is an honest guy. He will tell you there are no toxicological studies. See an example of a Blake Stark response to a request for toxicological studies, labeled as Appendix D-67.
NSF official Stan Hazan has admitted in deposition that fluoride suppliers do not submit toxicological studies on silicofluorides, that NSF itself has not done toxicological studies on silicofluorides (See Hazan deposition, p. 18.), and that the NSF possesses no toxicological studies on silicofluorides. (See Hazan deposition, p. 17, 50, 65.)
Further, even if NSF did have toxicological studies it would not turn them over and the public would not be allowed to read them, because they are considered proprietary. (Ibid., p. 63.)
Individual test reports, as well as formulation information are protected by nondisclosure agreements with certification clients.
NSF took over fluoride regulation from the EPA but NSF Standard 60 is a private document. To read it you must pay $325 for it. Water departments I have talked with do not even possess a copy of the Standard 60 book.
Nevertheless, WAC 246-290-220(3) requires Washington water districts to conform to NSF Standard 60. Hazan has bragged in the past that some 43 states have similar laws. The number is now up to 47 states and nine provinces or territories.
Page iii of NSF Standard 60 states:
This document has been reviewed by the Office of Drinking Water, U.S. Environmental Protection Agency, and approved for publication. … Partial funding by USEPA for the development and implementation of NSF Standard 60 (USEPA Cooperative Agreement #CR-812144) ….
On the same page NSF adds that EPA approval for publication “… does not signify that the contents necessarily reflect the views and policies of USEPA…”. The EPA is apparently afraid of something.
The EPA lacked authority to regulate the addition of fluoride to drinking water, but the EPA nevertheless granted authority to the NSF and assisted the NSF to go into the fluoride regulation business. NSF right away wrote Standard 60 under the guidance of the EPA and started regulating the addition of fluoride to drinking water.
NSF is a private trade group that has apparent governmental authority and carries out functions normally conducted by a government agency. Because it is a crypto-agency carrying out crypto-administrative functions, any copyright NSF may have on publication of NSF Standard 60 is void. We the people own this document. Federal government publications and those funded by the federal government cannot enjoy copyright protection. Therefore, the NSF Standard 60 is posted on the www.Fluoride-Class-Action.com web site for all to read.
Note that, according to Hazan, NSF claims to follow the EPA 4 ppm Maximum Contaminant Level for fluoride:
NSF has based its certification on the product use not exceeding the EPA’s MCL [maximum contaminant level] for fluoride. …
NSF was using the EPA 4 ppm MCL for a purpose for which the EPA could not use it, that is to authorize the addition of fluoride to drinking water up to the 4 ppm MCL. The people running NSF do not understand or do not care what the SDWA forbids.
Contaminants in the finished drinking water are not permitted to exceed one-tenth of the EPA’s regulated MCL (Maximum Contaminant Level) when the product is added to drinking water at its Maximum Use Level, unless it can be documented that a limited number of sources of the contaminant occur in drinking water.
Just as NSF does not enforce its requirement that there be toxicology studies, it also fails to follow its own one-tenth rule. Instead of setting a .4 ppm MAL, maximum allowable level, which would be one-tenth of the EPA 4.0 ppm MCL, NSF sets a 1.2 ppm MAL and justifies it in this way:
An MAL of greater than 10% of the MCL can be established by the certification body in limited cases if it can be reasonably documented that there are no other significant sources of the same contaminant, that together, would result in the finished drinking water contaminant concentration exceeding the MCL. Fluoride has an MAL of 1.2 mg / liter, which is 30% of the MCL. This is justified on the basis of the limited number of other potential sources of fluoride ion to drinking water. For example, water that naturally contains sufficient fluoride is not additionally fluoridated, and fluoride is seldom present in other additives.
The justification given is that there are no other sources of fluoride that add to the 30 percent load. However, there are many other sources of fluoride besides the fluoride added to drinking water, the greatest being common fruits, grains, beverages. The Environmental Working Group notes, for example, that dried eggs contain up to 900 ppm fluoride and that one-third of all eggs are dried and then added to food products. Grains are fumigated with sulfuryl fluoride to kill weevils and rodents, and the grain is fed to the chickens. See Wikipedia article on sulfuryl fluoride. I would rather eat a few weevils than eat sulfuryl fluoride.
Children swallow toothpaste, sometimes accidentally and sometimes because they love the flavor. I talk with fluoride hyper-sensitives. Generally, they became hypersensitives by being overdosed on fluoride, and that often happens when they lock themselves in the bathroom and eat toothpaste. The law should at least require that fluoridated toothpaste not taste good.
Most fluoride supporters now concede that fluoride does not prevents decay systemically, that is by being consumed. Most fluoride supporters retreat to a fall-back position, that fluoride prevents decay through topical application, that is via toothpaste and mouthwash, and dental varnish. Others argue that glass like enamel is not easily penetrated by fluoride and that fluoride is effective neither systematically nor topically.
Washington law, WAC 246-290-220(3), requires that
any treatment chemicals with the exception of commercially retailed hypochlorite compounds such as Clorox, Purex, etc., added to water intended for potable use must comply with ANSI/NSF Standard 60.
We are coming full circle now. Municipalities rely on the NSF for certification that the fluoride it buys is not harmful. By law, municipalities must conform to a sham regulation created by a sham agency which got its authority through an illegal assignment from the EPA, and which utilizes semi-secret regulations to which almost no one has access because an arbitrary $325 price is set on the purchase of the NSF 60 regulation.
The sham regulation is invalid on its face for two reasons: First, NSF assures us in writing that there are toxicological studies while there are none. Second, NSF does not follow its own one-tenth rule when it comes to fluoride.
Everett, Seattle, and Port Angeles all use fluorosilicates as their fluoridation materials. I know of no water district in Washington that uses sodium fluoride. Note that the February 2008 NSF Fact Sheet on Fluoridation Chemicals discusses “fluosilicic acid.” Fluosilicic acid, flurosilicic acid, and hexafluorosilicic acid are all the same thing.
Port Angeles is typical. It is “fluorosilicic acid” which Port Angeles is adding to city water. See the October 28, 2008, letter from Gregg Grunenfelder of the Department of health to Eloise Kailin, Appendix D-71. Mr. Grunenfelder says what pretty much all water districts say:
[W]e rely on national certification protocols to ensure the safety of water additives. Specifically, Washington Administrative Code 246-290-220(3), requires that: “Any treatment chemicals … must comply with ANSI/NSF Standard 60…. Since the fluoridation product being used by the city of Port Angeles is certified under NSF Standard 60, the city’s use of this product is in compliance with state law.
NSF Standard 60 is regarding by all agencies in Washington as having the force of law.
What is fluosilicic acid? The February 2008 NSF Fact Sheet on Fluoridation Chemicals, describes this chemical:
[F]luosilicic acid is produced by adding sulfuric acid to phosphate ore. This is typically done during the production of phosphate additives for agricultural fertilizers. … The most common contaminant detected in these products is arsenic …. The current MCL for arsenic is 10 ppb, the highest detection of arsenic from a fluoridation chemical was 0.6 ppb …. The third most common contaminant found is lead … with 0.6 ppb being the highest concentration detected [emphasis added].
However, the MCLG, the maximum contaminant level goal, for arsenic and lead are both zero. See 40 CFR 141.51. These chemicals are so nasty that there is no justification for adding any of them to drinking water. Fluoride is a little more toxic than lead, a little less toxic than arsenic. However, the MCL for lead is 15 ppb; the MCL for arsenic is 10 ppb; but the MCL for fluoride is 4,000 ppb, that is 4.0 ppm. See Clinical Toxicology of Commercial Products, 1984, which explains that the LD-50, the amount of a chemical which will kill 50 percent of subjects, is approximately the same for fluoride, lead, and arsenic.
The typical silicofluoride bill of lading or MSDS contains exculpatory clauses such as this one from Pelchem:
DISCLAIMER OF EXPRESSED AND IMPLIED WARRANTIES:
Although reasonable care has been taken in the preparation of this document, we extend no warranties and make no representations as to the accuracy or completeness of the information contained herein, and assume no responsibility regarding the suitability of this information for the user’s intended purposes or for the consequences of its use. Each individual should make a determination as to the suitability of the information for his or her particular purpose(s).
If there is any doubt regarding the bogus nature of NSF Standard 60, read through it looking for any reference to the 2006 NRC Report. There is none. Thus, NSF standards are at best outdated, and Seattle, Everett, Port Angeles, and every other Washington water district which fluoridates is relying on a sham regulation that is outdated.
Tudor Davies, former director of the Office of Science and Technology for the EPA stated in his April 2, 1998, letter to George Glasser the following:
In the United States, there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water. In the past the EPA assisted the States and public water systems through the issuance of advisory opinions on acceptability of many additive chemicals. However, the Federal advisory program was terminated on October 4, 1988, and EPA assisted in establishment of voluntary product standards at NSF International (NSF) …. NSF Standard 60 … was developed by NSF by a consortium of representatives from utilities, government, manufacturers and the public health community. [emphasis added]
So this is how the shell game works. Most people, including elected and appointed officials, naively assume that the EPA has jurisdiction over drinking water fluoridation through the SDWA, and that the EPA helped start NSF and gave it legitimacy. The NSF still brags that it was set up by the EPA. On its history page NSF says “1985 – Drinking Water Additives Program starts with a cooperative agreement from the US EPA.” I would like to see that “cooperative agreement.”
The NSF pretends to be authoritative, and pretends to have inherited its authority over fluoride from the EPA, and so people trust it when its fact sheet mentions health, safety, inspections, and toxicology. What is going on is that the NSF is pretending to do what the EPA by law is barred from doing, to authorize and regulate the addition of fluoride to water.
Water commissioners are often deceived by the shell game. This is a different kind of shell game. In the old days there was a pea under one of the walnut shells. In this case, there is no pea under any of the shells.
Given that no federal agency is empowered to write regulations which require that fluoride be added to drinking water, the next question is whether there is a Washington agency which does so. The Department of Health is the lead agency for enforcement of the SDWA in Washington, but, like the EPA, it too is bound by the limitations of the SDWA and is forbidden by the SDWA from writing a regulation requiring the addition to water of “any substance for preventive health care purposes unrelated to contamination of drinking water.”
Technically the Department of Health does not require the addition of fluoride to water, it merely says that if a municipality chooses to fluoridate, it must follow certain fluoridation practices including WAC 246-290-460, which requires that fluoridation materials conform to NSF Standard 60. The Department of Health thus endorses NSF Standard 60 and adopts it by reference as a Washington administrative regulation.
The hotball has been tossed by the FDA to the EPA to NSF to state departments of health and finally to local water districts. It is the municipalities that make the ultimate decision to fluoridate. However, they make their decision based on the genuine but ill founded endorsement from the Department of Health and on the false certification from the sham NSF regulatory agency that silicofluorides are good and harmless.
The EHC analysis and recommended decision concluded
3) The Board cannot direct a federal agency to take action.
However, our petition for rule making does not ask the Board to direct the FDA or any other federal agency to take any action. Our petition simply calls for fluoridation to be authorized only if fluoridation materials are approved by the FDA – or some other genuine federal or state agency. The Board should require that water districts make application with the FDA for a CDER (Center for Drug Evaluation and Research) New Drug Approval (NDA) as required by the FD&C Act (Food Drug and Cosmetic Act) for drug manufacturers prior to marketing.
The EHC analysis and recommended decision also concluded
4) The State Board of Pharmacy has stated it cannot regulate tap water fluoridation under its authority.
The petition did not ask the State Board of Pharmacy to approve the petition for rule change. It does point out that the State Board of Pharmacy is in error when it says it lacks jurisdiction to regulate and approve or disapprove the fluoride-water mixture – because it meets the definition of a drug under Washington law. According to RCW 69.41.010 the term “drug” includes:
(a) Substances recognized as drugs in the official United States pharmacopoeia…;
(b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or animals;
(c) Substances (other than food, minerals or vitamins) intended to affect the structure or any function of the body of human beings or animals….
Note that it is the intent of use that makes one chemical an additive and another a drug. If it is intended to treat the water by adjusting pH or killing bacteria, it is an additive. If the intent of use is to treat or prevent disease, it is a drug.
Likewise, the State Board of Pharmacy has the authority and the duty to regulate drug manufacturers and require their licensure. RCW 18.64.005 says the Board of Pharmacy shall:
Promulgate rules for the dispensing, distribution, wholesaling, and manufacturing of drugs and devices and the practice of pharmacy for the protection and promotion of the public health, safety, and welfare.
The State Board of Pharmacy, could assert jurisdiction over the regulation and licensure of the fluoride water drug mixture, and it should.
The EHC analysis and recommended decision also concluded
5) An NRC committee evaluated the scientific evidence of the health effects of fluoride in drinking water and published a report in 2006 that concluded fluoride levels in drinking water below 2ppm are safe for health.
This is an incorrect statement. Washington Action for Safe Water issued a Public Information Disclosure Request to the Board of Health, asking the Board to point out any statement from the 2006 NRC report which concluded that “fluoride levels in drinking water below 2 ppm are safe for health.” The Board failed to provide any such statement. The 2006 NRC Report simply does not make that statement or come to that conclusion.
The EHC analysis and recommended decision also concluded:
6) EPA announced completion of a review of MCLs in the Federal Register in March 2010 that concluded it did not have evidence to revise the MCL for fluoride.
7) EPA will be conducting additional reviews regarding fluoride levels in drinking water.
Again, the Board of Health is relying on erroneous information. The SDWA, which regulates the EPA and limits what it can do, states at 42 USC 300g-1(b)(11):
No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.
The EPA might be planning to conduct reviews of naturally occurring calcium fluoride which would look into whether it should be removing naturally occurring or pollutant added fluoride from drinking water if it exceeds 4 ppm or whether EPA should lower this threshold. However, it will not be conducting any reviews regarding adding fluoride to water for health care purposes.
The EHC analysis and recommended decision also concluded:
8) EPA recognizes NSF/ANSI Standard 60 as appropriate for the approval of drinking water additives.
Yes, the EPA recognizes NSF 60. It even “approved” and financed its publication. However, the EHC and the Board of Health have been deceived like most other elected and appointed officials. NSF Standard 60 is a sham law, and NSF is a sham agency which fails to enforce its own rules.
The EHC analysis and recommended decision also concluded:
9) The range of 0.8 ppm to 1.3 ppm fluoride in WAC 246-290-460 is within the control range (0.1 ppm below to 0.5 ppm above) recommended by CDC for target “optimal” concentrations based on average maximum temperatures in various regions of Washington.
The Board errs in deferring to the CDC for a safe range of fluoride concentration, 0.8 ppm to 1.3 ppm as recognized in WAC 246-290-460. Although the CDC promotes fluoridation, it admits that “…it is not CDC’s responsibility to determine what levels of fluoride in water are safe….”
The EHC analysis and recommended decision also concluded that because the
… FDA has stated it has no intention to regulate fluoride levels or approve additives for tap water, … adopting the proposed rule changes would, essentially, prohibit all tap water fluoridation in Washington and make Board rules conflict with RCW 57.08.012.
The EHC is reasoning that RCW 57.08.012 gives water districts the right to choose to fluoridate and that any regulation which would not leave the water districts without approved fluoridation materials would thus make it a practical impossibility for water districts to fluoridate. The EHC reasons that RCW 57.08.012 is a statute passed by the legislature and that a Department of Health administrative rule should not “trump” a statute. No, the statute is still in place. Water districts can still vote to fluoridate but only with quality fluoridation materials of the proper dosage established by a valid governmental agency. If water districts in Washington were receiving fluoridation materials which turned out to contain excessive amounts of lead, would the Department of Health not have the authority to suspend fluoridation until the problem were resolved? Of course it would.
The Board further has the power to enact a regulation stating that there is no currently safe or pure form of pharmaceutical grade fluoridation materials currently available, and thus – despite what RCW 57.08.012 says – the practice of fluoridation is indefinitely suspended. That is what it could do and what it should do.
The problem with the logic of the EHC is that the EHC begins not with the law and the science but with the deep conviction that fluoridation must not stop. To get to that result the EHC bends and twists numerous laws to allow fluoridation to continue.
The Department of Health and its secretary are granted broad powers under RCW 43.70.130, including the power to
Review and approve plans for public water system design, engineering, operation, maintenance, financing, and emergency response
Under RCW 43.20.050, the Board of Health
Shall adopt rules for group A public water systems, as defined in RCW 70.119A.020, necessary to assure safe and reliable public drinking water and to protect the public health.
WAC 246-290-220(3) requires Washington water districts use only treatment chemicals which conform to NSF Standard 60:
Any treatment chemicals, with the exception of commercially retailed hypochlorite compounds such as unscented Clorox, Purex, etc., added to water intended for potable use must comply with ANSI/NSF Standard 60.
We have demonstrated above that NSF does not enforce important provisions of NSF Standard 60 as it applies to fluoridation materials. Therefore, there are no available fluoridation chemicals which conform to NSF Standard 60.
Therefore, and for this additional reason, the board could enact a regulation stating that because no fluoridation materials are available which comply with NSF Standard 60 that fluoridation is indefinitely suspended.
The EHC also said:
The Board does not appear to have authority to adopt rules related to a water district deciding whether to fluoridate. The Board’s authority is to regulate allowable concentration levels and method of approval of water additives.
The petition did not ask the Board to decide whether to allow water districts to fluoridate. It asked that the Board require that fluoride materials be pharmaceutical grade and be approved by the FDA (or any federal or state agency), as the law requires be done regarding any drug intended to treat people. It is within the authority of the Board of Health to require water systems to obey state and federal drug laws when drugs are added to the water. Fluoridation materials should not be exempted from all other laws applying to drugs just because of a false hope that it strengthens teeth.
Under RCW 43.20.050(2) the Board of Health has broad authority to adopt rules for Group A public water supplies “necessary to assure safe and reliable public drinking water and to protect the public health.” And further under RCW 70.142.010 the Board of Health has the following broad powers:
(1) In order to protect public health from chemical contaminants in drinking water, the state board of health shall establish by rule standards for allowable concentrations. … Standards set for contaminants known to be toxic shall consider both short-term and chronic toxicity.
(2) The board shall consider the best available scientific information in establishing the standards. … State and local standards for chemical contaminants may be more strict than the federal standards.
If shipments of fluoride are arriving in the state which contained high levels of unknown contaminants, the Board of Health has the power to halt fluoridation pending an investigation. The Board of Health as part of the Department of Health has power to declare that there are currently no acceptable fluoridation materials available or set an allowable fluoridation level of zero, if such level would protect public health. There would certainly be no upsurge in dental caries if fluoridation were halted for a year, given the fact that even fluoride supporters now admit that the beneficial effect of fluoridation materials is topical, not systemic, that is through tooth brushing and not drinking fluoride.
At minimum the Board of Health should put a hold on fluoridation so proper notices could be sent out. Statewide our water districts have a serious lead problem. Federal law mandates that water districts give lead notices. A water district must as
owner or operator of a public water system … identify and provide notice to persons that may be affected by lead contamination of their drinking water where such contamination results from … lead content in the construction materials of the public water distribution system [or] corrosivity of the water supply sufficient to cause leaching of lead. … Notice under this paragraph shall be provided notwithstanding the absence of a violation of any national drinking water standard.
Likewise, water districts should send notice to those with kidney disease. These people are extremely sensitive to fluoridation materials because fluoride builds up in already impaired kidneys and further reduces the ability of kidneys to excrete fluoride, resulting in a fluoride buildup and a downward spiral. The National Kidney Association – subsidized by the CDC and under pressure from it – reluctantly withdrew its previous endorsement of fluoridation and admitted the following:
Individuals with CKD should be notified of the potential risk of fluoride exposure by providing information on the NKF website including a link to the report in brief of the [2006 NRC Report, page 81, 236] and the Kidney Health Australia position paper [“avoidance of fluoride rich substances would be prudent for people with stage 4 or 5 CKD”].
Likewise, water districts should send notice to parents of infants and young children. According to the American Dental Association
If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis. These include water labeled as purified, demineralized, deionized or distilled, as well as reverse osmosis filtered water.
These and other groups which are highly sensitive to fluoride should receive special notice, and halting fluoridation for a time would be the best way to prepare for and give the notice.
While I am on the subject of high lead levels, I should point out another poor job of analysis by your Environmental Health Committee, this time dealing with “Childhood Lead Poisoning Prevention.” The proposed lead action plan made no mention of the biggest source of lead poisoning, silicofluorides which contain lead, leach lead from lead pipes and solder, and which encourage lead uptake.
In declaring that there are currently no fluoridation chemicals which conform to NSF Standard 60, the Board would not be deciding whether water districts can fluoridate. It would merely be saying that at present there are no fluoridation chemicals suitable for fluoridation.
Further, although RCW 57.08.012 does authorize water districts to fluoridate, it does not authorize them to fluoridate when there are no approved fluoridation materials. Nor does it exempt fluoridation from general or federal and state laws which require approval by the FDA or some other federal or state agency which has jurisdiction over substances used with the intent to prevent disease, and which thus meet the definition of “drugs.”
The general public perception, as well as the perception of the individual water districts and cities, is that the Board of Health has authority to regulate the addition of fluoride to the public water supply and that the NSF 60 Certification can be relied on.
The Board of Health EHC in its EHC analysis and recommended decision has given you a collection of pro-fluoride interpretations of law and science which are riddled with errors. You are a lawyer, so you can follow my legal arguments. You ought to familiarize yourself with the relevant science. I suggest you refer this issue to a group of attorneys who have science backgrounds. A lot of people have been injured by fluoridation, and water districts and state agencies could be sued for damages and for injunctive relief and damages under 42 USC 1983, 1988. Exposure could be significant.
Governor Gregroir, you had the courage to stand up to the tobacco companies. Do you have the courage to stand up to the chemical corporations?
James Robert Deal
President of www.Fluoride-Class-Action.com
PO Box 2276, Lynnwood, WA 98036
425-771-1110 (Fax 425-776-8081)