Notice of collective and individual non-compliance, unlawful activity, misrepresentation and liability regarding use of hydrofluosilicic acid
Intended recipients
This Actual and Constructive Notice is directed to all parties responsible for the performance of due diligence, and in the chain of information gathering and dissemination, as well as any decision-making, concerning hydrofluosilicic acid and its contaminants, which are stored, shipped, handled, and ultimately delivered to consumers of Crescent City’s public drinking water; and, as public record, is to serve as notice to all parties specifically concerned with the issues represented herein, including the public at large.
Responsible parties for purposes of this Notice include, but are not limited to: the City of Crescent City; the Mayor; the City Council, collectively and as individuals; the attorney of record; the water quality administrator and any responsible staff; and any general administrators that possess authority in fields that address actions pertinent to safety, risk management, emergency preparedness and remediation, contract fulfillment, permitting, financial disclosure, environmental assessment, and stewardship of public resources.
Identifying misrepresentations and omissions
This Notice herein identifies historical as well as current misrepresentations and omissions of material fact concerning fluoridation chemicals and their contaminants, perpetrated either individually or collectively, with specific action or omission, by the manufacturers of the fluoridation products, California Department of Health, Centers for Disease Control, NSF International, California Dental Association, American Dental Association, individual fluoridation promoters, and the City of Crescent City, its City Council, and its officers and representatives.
This Notice also contains references and allegations of fact concerning accountability; transparency, and disclosure of specific content of the product; compliance with California laws, rules and regulations; and conformance with industry standards, for which the recipients of this Actual and Constructive Notice have a duty to perform due diligence.
1) Importance of this Actual and Constructive Notice to the recipients
This Actual and Constructive Notice is delivered in accordance with the following terms:
a) This Actual and Constructive Notice is delivered in accordance with California Civil Code Sections 18 and 19, which states in CCC §19, “Every person who has actual notice of circumstances sufficient to put a prudent man upon inquiry as to a particular fact, has constructive notice of the fact itself in all cases in which, by prosecuting such inquiry, he might have learned such fact.”
b) Actual Notice is defined as, “knowledge of facts and circumstances sufficiently pertinent in character to enable reasonably cautious and prudent persons to investigate and ascertain as to the ultimate facts.”
c) Constructive notice is defined as, “information or knowledge of a fact imputed by law to a person (although he may not actually have it), because he could have discovered the fact by proper diligence, and his situation was such as to cast upon him the duty of inquiring into it.”
d) CCC §18 further states that Actual Notice is expressed information of fact, and that Constructive Notice is imputed as law.
e) In this context, “imputed” is defined as, “To attach to a person responsibility (and therefore financial liability) for acts or injuries to another, because of a particular relationship.” (Parenthesis included in definition)
2) Statement of issues
a) Legislative intent of City’s fluoridation program is to alter the consumers’ physical structure through a substance delivered in the water supply
Under Crescent City’s fluoridation scheme, for the purpose of effecting a change in the physical structure of the recipient consumers’ teeth to become more resistant to the incident of caries (tooth decay), the City injects hydrofluosilicic acid and its contaminants into treated water that it delivers to the public.
b) The City’s Council has represented to the public that their specific program of fluoridation will safely and effectively reduce tooth decay
Upon challenge from consumers and citizens, and requests to review the current science on hydrofluosilicic acid, the City and responsible parties, including the Council collectively and some Council Members individually, have represented that the program the City implements is safe and effective and without risk of harm to consumers.
c) City’s knowledge of product’s inability to fulfill objective
The City and each individual recipient of this Notice has been provided evidence that neither the City’s current supplier, nor any other chemical manufacturer of hydrofluosilicic acid in the U.S. and Canada, will declare under the condition of purchase that their product will fulfill the legislative intent of safely and effectively reducing tooth decay, and that no manufacturer of hydrofluosilicic acid has been willing to provide documentation of their product data submissions, which are required in order to merit certification by the direct water additive standard adopted by California law.
The recipient responsible parties, including the City Attorney and staff responsible for water quality, have had sufficient opportunity to review the requests made to each chemical manufacturer of hydrofluosilicic acid, including the City’s current supplier, to affirm whether their specific product will safely and effectively fulfill the intended health goal, and that the manufacturer will submit copies of the exact documents they are required to submit to merit certification of their compliance with California law.
The responsible parties that are recipients of this Notice, including the City Attorney, know, or with reasonable care should know, that endorsements are not a substitute for product accountability.
d) Misrepresentations to the public
The City Council, collectively, and other responsible parties in the chain of delivery, have knowingly withheld information that a prudent consumer would find material in making their own determination of the safety of the water they and their children may consume, cook with, and bathe in, and its effectiveness in reducing their incidence of tooth decay.
The parties know, or with reasonable care should know, that these acts of omission and commission, upon which consumers of the City’s water do rely, may have deleterious and injurious effects, and to that point their actions and/or inactions are negligent, fraudulent, not in compliance with California law, and a misuse of public funds.
3) Scope of responsibility for Notice recipients, including liabilities
a) This Notice encompasses actions and omissions for which a responsible party should recognize he/she has direct control and a duty, but also further clarifies duties an entity in the chain of delivery of a product bears within the application of the doctrines of Learned Intermediary and Sophisticated User.
b) While California courts have routinely maintained that all entities in the chain of delivery of a product are subject to review for liability, the doctrines of Learned Intermediary and Sophisticated User have been historically employed as a shifting of the weight of responsibility and liability to entities other than manufacturers in the chain of delivery of their products to consumers.
c) The doctrine of Learned Intermediary proposes that an entity other than the manufacturer in the chain of delivery has specialized knowledge of the user of the product and is considered to be in a direct position for which the recipient consumer develops a trust that this entity in the chain of delivery will fully inform and warn them of dangers, risks and contraindications.
d) One of the few exclusions to this doctrine is that the duty to inform and warn is tempered by a determination that a Sophisticated User “could reasonably be expected to know,” which also assists in establishing the scope of when an entity MUST inform.
e) Under the “consumer expectations test” as adopted by the California courts, which generally rely on Section 388 of the Restatement of Torts, suppliers of products can be liable to users of those products, “if the supplier (a) knows or has reason to know that the [product] is or is likely to be dangerous for the use for which it is supplied, and (b) has no reason to believe that those for whose use the [product] is supplied will realize its dangerous condition…“
f) A court decision explains that, “One who supplies a [product] to others to use for any purpose is under a duty to exercise reasonable care to inform them of its dangerous character … if, but only if, he has no reason to expect that those for whose use the [product] is supplied will discover its condition and realize the danger involved.”
4) Water consumer cannot reasonably be expected to know of risks
a) Whether a water consumer “could reasonably be expected to know” of the hazards or risks of a direct water additive, hydrofluosilicic acid and its contaminants such as arsenic, is easily answered when responsible entities in the chain of delivery act in concert to misrepresent or omit the existence of evidence of harm and risk, continually represent the addition as “fluoride” without public disclosure of the specific nature of the actual product and its contaminants, and continue to provide exaggerated assurances of safety and effectiveness.
5) Duty to perform due diligence and act to correct all misrepresentations, omissions, and unlawful practices, even as perpetrated by others in the chain of delivery or marketing
You know, or with reasonable care should know, that as a Learned Intermediary for products which you add to the public drinking water, and claims you collectively and individually make about the product and the resulting quality of water, you as a responsible party of Crescent City possess the authority, the responsibility, and the duty to perform due diligence in order to assure all statutory and regulatory requirements are fulfilled for the products you use and the drinking water your consumers purchase, and to correct all unlawful practices and misrepresentations or omissions of material fact prior to delivery to an unsuspecting and a recognized unsophisticated user.
6) Water operator’s requirement to select a product that meets ANSI/NSF Standard 60
Title 22, Chapter 16, Article 7, § 64590. Direct Additives: “No
chemical or product shall be added to drinking water by a water supplier unless the chemical or product is certified as meeting the specifications of NSF International/American National Standard Institute (NSF/ANSI) 60-2005 (Drinking Water Treatment Chemicals–Health Effects), which is hereby incorporated by reference.”
1) No exemption from published standard
It is clear by this code that it is the responsibility of the water system operator to assure that a chemical is in compliance with Standard 60, and provides no exemption for rhetoric, trade association opinion or historical assumption.
2) Notice of admission of noncompliance; duty to perform due diligence
In a July 7, 2000 response by NSF International to Congressional investigation by the House Committee on Science, and subsequent confirmation in a March 10, 2004 under-oath deposition testimony by the author of the response, Stan Hazan, NSF indicates that despite their issuance of certifications and approvals, no manufacturer of fluoridation chemicals has fully complied with ANSI/NSF Standard 60 General Requirement 3.2.1, as published, even under the Business Confidentiality Act.
Non-compliance with Section 3.2.1 is not a minor oversight. In order to be certified by NSF that the manufacturer is in compliance with Standard 60, this section requires that a manufacturer shall submit a list of toxicological data, both published and unpublished if available, on the manufacturer’s product, and all of its components, including any and all contaminants present. Omission of this critical data from every manufacturer of fluoridation chemicals not only lends itself to suspicions of collusion, but also reinforces the statutory necessity for the water supplier to confirm compliance from their specific chemical provider.
In addition to the manufacturer/producer, ANSI/NSF Standard 60 also requires other entities in the chain of delivery of a product, including re-packagers, to conform to General Requirements and annual inspection.
3) Proof of compliance/violation of State law
With this Notice of NSF admissions, you know or with reasonable care should know, that any certification of the manufacturer for purposes of delivering fluoridation chemicals is not a reliable source for verification; and as NSF has previously and continuously provided certifications with knowledge that the manufacturers had not met these certain requirements as published, any statement by NSF would be suspect without specific dated, true and correct copies of Product Review Data as proof.
We thus hereby provide you with formal notice that in the face of evidence indicating non-compliance, any action on your part to select a direct water additive, make estimates for purposes of obtaining grants, entering into any contract with third party funding source, submitting application for permit, establishing specifications for bid, and purchasing a direct water additive, that does not assure and enforce a specific product’s factual fulfillment of Standard 60, is in violation of California law.
4) Manufacturers will not attest to safety and effectiveness
To date not one manufacturer of hydrofluosilicic acid in the U.S. and Canada has been willing to declare that their specific product is effective at reducing tooth decay when swallowed, or safe for infants, children, the elderly, and susceptible populations afforded equal protection.
5) Cease all actions until accountability for product data and manufacturer’s compliance is proven
Adherence to California law compels that you immediately cease and desist all actions without confirmation that a specific product producer/manufacturer or distributor has met all requirements of Standard 60, without reliance on what may be faulty certification, i.e., by submitting to you a copy of the actual document the producer or supplier submitted to NSF in general requirement for certification under general requirement Section 3.2.1, providing a declaration of the complete contents and the extent of each impurity for their individual product, and listing the toxicological data on all components and each contaminant of their product.
6) Liabilities to individuals for inadequate disclosure of risk
We also hereby provide formal notice that as a learned intermediary any actions that do not heed these aforementioned violations of code, may expose you to liabilities for which you may not have provided adequate disclosure of known or reasonably anticipated risks to financial auditors for the purpose of establishing appropriate credit ratings, or securing adequate insurance coverage to cover the breadth of potential claims.
Failure to address the risks inherent in noncompliance in a timely fashion, and its subsequent disclosure, may trigger exceptions to the normal protections of individuals acting on a governing body’s behalf.
7) Due diligence requires declaration from manufacturer; negligence
a) You know, or with reasonable care should know, with notice of the publication of the National Research Council Report on Fluoride in December 2006, including evidence of thyroid impairment at fluoride levels below expected consumption levels of "optimally" fluoridated tap water without considering other exposures; new recommendations from the American Dental Association for not using fluoridated tap water to mix infant formula; a shift in the scientific determination of the mechanism by which fluoride may benefit oral health; and the publication of two new and only toxicological studies on the health effects of continued use of fluorosilicic products; a water operator would be negligent to not confirm with the actual manufacturer of the product the extent to which the manufacturer will attest to their product’s performance and safety for extended use.
b) Disseminating information, including safety and effectiveness claims for the addition of hydrofluosilicic acid to drinking water, without revealing that as of May 15, 2011 there are only two toxicological studies on the health and behavioral effects of continued ingestion of the hydrofluosilicic acid substance that is injected into Crescent City’s water supply, and that prior to February 2010 Crescent city was injecting a hydrofluosilicic acid product for which the U.S. EPA could not identify ANY toxicological studies on the health and behavioral effects of continued use, is a misrepresentation and omission of material fact.
c) You know, or with reasonable care should know, that in 2009 the Carcinogen Identification Committee for the California Office of Environmental Health Hazards Assessment (OEHHA) selected two classifications of fluorine-containing compounds to include in their top five priorities out of 83 chemicals to determine whether the human and animal evidence already displaying carcinogenicity rises to the level of meriting a universal California warning as cancer-causing under Proposition 65, just as is required for lead.
While the determination of whether a State-wide warning will be ordered is due this year, the existence of the evidence of carcinogenicity has already been established and was necessary in order to establish the two classifications as a priority for final review.
The omission of Crescent City and its responsible parties in addressing the toxicological studies on the health effects of continued use of the specific classification of the fluoridation chemical that Crescent City injects into the public water supply is negligent and capricious. Non-disclosure of the existence of evidence of carcinogenicity while perpetuating claims of absolute safety and effectiveness constitutes a material misrepresentation and fraudulent action against the public and unsuspecting consumers.
8) Learned Intermediary duty of care places responsibility on any failure to warn on final deliverer of product.
a) You know, or with reasonable care should know, that in addition to the 2006 NRC Report on Fluoride’s unanimous determination that current points at which a water district must remediate fluoride concentrations (MCL) is not protective of human health, the American Dental Association (ADA) and the American Academy of Pediatrics (AAP) have published recommendations to their memberships to control the amounts of fluoride that their members should prescribe to their patients in place of water fluoridation.
b) Centers for Disease Control (CDC) incorporates these recommendations on their web site intended to answer questions from the public. In addition, ADA and CDC have issued special warnings that parents should not mix infant formula with fluoridated tap water.
c) As a Learned Intermediary, any exposures to hydrofluosilicic acid through the public water system without dissemination of information and warning to the actual consumers, giving them enough time to institute protections, would appear to be an intentional assault on a recipient base that is reliant on your duty of care.
d) Failure to inform and warn the actual consumers and parents that the concentrations of fluoridation chemicals added to the water are estimated to deliver several times the amounts of fluoride that a health professional in a non-fluoridated community can now prescribe to an infant or child under six years of age would constitute a willful assault on unsuspecting residents.
e) Charts from the December 2006 NRC Report on Fluoride show that infants and children with average water consumption, and especially infants and children with higher volumes of water consumption, will suffer from exposures that exceed the U.S. Environmental Protection Agency’s Reference Dose (RfD) for fluoride, the point above which risk assessments consider unsafe.
9) NSF is not able to discharge any responsibility of the manufacturer or any other party
a) NSF International is not a government agency, and has no duty of care to consumers.
b) NSF Disclaimer: “NSF, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party.”
10) Manufacturer’s Safety Data Sheets do not fulfill published NSF requirements as adopted by California
a) With this Notice the recipients shall also be informed that a Manufacturer’s Safety Data Sheet (MSDS) is not a valid substitute for specific submissions required by ANSI/NSF Standard 60, as an MSDS is not intended to, and does not, address the scope of data required by Section 3.2.1, which includes as published:
i. A proposed maximum use level for the product;
ii. The composition of the formulation (in percent or parts by weight for each chemical in the formulation);
iii. The reaction mixture used to manufacture the chemical if applicable;
iv. Chemical abstract number (CAS number), chemical name, and supplier for each chemical present in the formulation;
v. A list of known or suspected impurities within the treatment chemical formulation and the maximum percent or parts by weight of each impurity;
vi. A description or classification of the process in which the treatment chemical is manufactured, handled and packaged;
vii. Any selected spectra (e.g. UV/visible, infrared) that has been required; and
viii. A list of published and unpublished toxicological studies relevant to the treatment chemical and the chemical and impurities present in the treatment chemical.
b) Furthermore, without details of contaminants, no interested party can determine whether the specific product fulfills the American Water Works Association AWWA B703 requirement Section 4.3.1 Impurities, General: “The fluorososilicic acid supplied according to this standard shall contain no minerals or organic substances in quantities capable of producing deleterious or injurious effects on the health of those consuming water that has been properly treated with fluorosilicic acid.”
c) You know, or with reasonable care should know, that this determination is not intended to be made by rhetoric or endorsement. Absent a statement by the manufacturer that their specific product is effective at reducing tooth decay when ingested and safe for all consumers at the range of water they drink, and absent appropriate submissions of data as required, all claims of safety and effectiveness are spurious, and the selection of the product capricious and without legitimate public benefit.
11) Without details of content and impurities of product, Crescent City cannot comply with regulatory requirements
a) You know, or with reasonable care should know, that in order to fulfill the City’s requirement for properly informing first responders, emergency remediation and response teams, risk management, homeland security, environmental impact review, and accurate assessments by the City for both contaminant quality controls and appropriate permitting, that understanding the exact contents and impurities is essential and negligent if ignored.
b) You know, or with reasonable care should know, that to establish appropriate engineering controls, protective clothing, monitoring devices, and record keeping for operations personnel to meet OSHA requirements it is necessary to determine with certitude the contents, impurities and contraindications of the exact product being handled.
c) You know, or with reasonable care should know, that to properly inform and comply with waste water handling and treatment regulations that the contents and impurities of any spill or leakage is essential.
d) You know, or with reasonable care should know, that should you no longer intend to use any amount of the specific hydrofluosilicic acid product, the product reverts to its hazardous classification that requires neutralization at the highest rated hazardous waste facility, and that the facility will require that you identify the content and impurities before submitting the product to them.
e) You know or with reasonable care should know that you have a personal responsibility to inform risk management of the true contents, contamination, and risks inherent in the use of the specific hydrofluosilicic acid product.
f) You know or with reasonable care should know that you are personally required to make disclosures, and liable for any omissions or misrepresentations, of risk, on all financial declarations by the City in obtaining loans, establishing credit, and issuing bonds.
12) EPA and CDC are misrepresented as controlling authority for safety of hydrofluosilicic acid; no federal safety standards for direct water additives
a) Any statement or inference that hydrofluosilicic acid meets EPA or any other federal agency safety standard is a misrepresentation and omission of fact.
b) On July 7, 1988, by Notice in the Federal Register (53 FR, 5586), U.S. EPA terminated oversight responsibilities for water additives in favor of industry-established standards which individual states or water suppliers are free to adopt.
c) Tudor T. Davies, Director, Office of Science and Technology, U.S. EPA, states in a letter to George Glasser on April 2, 1998, "In the U.S., there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water."
d) Neither U.S. nor California U.S. Maximum Contaminant Levels (MCLs), are safety standards for direct water additives.
e) MCLs are concentration points for specific contaminants at which the water operator is to limit a contaminant’s concentration in the public drinking water or remediate the excess. MCL’s are negotiated with consideration for the availability of methodology and unique costs of measuring and removing the contaminant from source water. They are not an invitation to “fill ‘er up” with a voluntary additive.
f) Hydrofluosilicic acid is a direct water additive. It does not occur in water naturally in its commercially available form, and is processed by the phosphate fertilizer industry without any federal quality control for safety or effectiveness of the product. Its production does not conform to Good Manufacturing Practices.
g) Statements of safety and effectiveness of hydrofluosilicic acid, coming from, or attributed to, Centers for Disease Control are equally misrepresentative, as the CDC has no authority from Congress to determine or endorse the safety or effectiveness of any manufacturer’s direct water additive.
13) Claim of safety and effectiveness for the specific product constitutes a drug claim regulated by the U.S. Food and Drug Administration
a) Congress has defined a drug as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles intended to affect the structure or any function of the body of man." (21 U.S.C. §321)
b) You know, or with reasonable care should know, that Crescent City’s selection of hydrofluosilicic acid to safely and effectively fulfill the purpose of affecting the physical structure and function of the recipient consumers’ teeth to become more resistant to the incident of caries (tooth decay) is an action included within this definition.
c) Congress has ordered, and the United States Food and Drug Administration (FDA) has replied to Congressional investigation, that the FDA is the only government agency with the authority to approve or reject any claim of safety or effectiveness for any product that is intended to cure, mitigate, treat or prevent any disease in man.
d) FDA states in their 2000 response to Congressional investigation on fluoride: "Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to FDA regulation," and that no fluorine-containing product intended for ingestion for the purpose of reducing tooth decay has ever been approved for safety and effectiveness.
e) Promoters of fluoridation and legislative bodies have attempted to circumvent this status by restricting their claims of safety and effectiveness to the public policy. Any statement that a specific manufacturer’s hydrofluosilicic acid is safe and effective thrusts that claim into the jurisdiction of the FDA and requires approval for such claim.
14) Memorandum of Understanding does not convey authority to EPA
a) Claims of authority derived from a 1979 Memorandum of Understanding (MOU) between the U.S EPA and U.S. FDA, in which the two parties appear to agree that U.S. EPA will perform duties concerning water additives, did at no time address water additives intended to perform as medication, treatment, prevention, or in any manner as drug, so was never on point for the issue of substances intended to treat humans rather than the water.
b) The 1979 MOU is further not controlling, and non-operative for U.S. EPA’s jurisdiction over direct water additives, as U.S. EPA terminated its informal advisory function on additives that was essential to the MOU Terms of Agreement, and gave up all oversight responsibilities for direct water additives in 1988.
15) Legal actions confirm U.S. Food and Drug Administration authority over safety and effectiveness of a product
a) The U.S. Supreme Court has confirmed that it is Congress and the language of the statute that controls the jurisdiction of the FDA Act, not a statement by an agency or another governmental entity. FDA v. Brown & Williamson, (529 U.S. 120 (2000)).
b) In a December 2003 decision of widespread importance, the U.S. District Court ruled, and was not challenged, that even the U.S. government under emergency conditions of war can not force an individual to be medicated with a substance that has not been specifically approved for the purpose it is intended, and especially approved in the manner it is administered.
c) The Court ruled that the approval of one substance, or manner of delivery, does not translate to an approval of another similar substance or different mode of delivery.
d) The Court clarified that the fact that the use of an anthrax vaccine was also subject to action by the FDA, and that the FDA had not taken action, did not refute the relevancy of the evidence that the drug was not approved by the FDA, and thus was "arbitrary" and therefore could not be sustained. (Doe v. Rumsfeld, 2003 U.S. Dist. LEXIS 22990 December 22, 2003)
16) Legal issue of fluoride’s harm has been settled in courts
a) In 1978-1982, with trials of 11, 14 and 40 days to allow for extensive expert witness testimony, courts in Illinois, Texas and Pennsylvania each came to the same conclusion: fluoride at one part per million in the water, a) aggravates existing illnesses, b) causes adverse health effects, and c) contributes to a significant increase in cancer deaths.
b) These are the only cases in U.S. history that have heard expert witness testimony to determine the scientific merits of the safety, effectiveness, or harm of fluoridation.
c) All three judges issued injunctions against further fluoridation. And their scientific determinations of harm have never been overturned, or been reconsidered by another court.
17) Distortion of rulings that determined harm
a) You know or with reasonable care should know that the claims of, “No court of last resort has ever ruled against fluoridation,” as an assertion of no harm, is an omission of material fact.
b) The rulings in these three cases had determined that the scientific test of harm had been proven beyond a reasonable doubt. The upper courts did not reverse these findings. They made a separate determination that legislative bodies had authorities with limited constraints — that this standard of proof that is sufficient in some states to convict and sentence a person to death was not in-of-itself sufficient to curtail a legislative body acting as the people’s representatives – that the standard for harm needed to be, “no controversy”; meaning if a legislative body had even one expert witness that would support their decision that an elected body deserved the authority to act. Exceptions to this expansive authority of representative bodies are actions that are arbitrary, capricious, or do not fulfill legitimate government interests, or otherwise interfere with constitutional rights.
c) You know, or with reasonable care should know, as a responsible party and a Learned Intermediary, that Crescent City’s selection of a substance that does not fulfill the legitimate public policy intent, or is not approved for the health claims of safety and effectiveness, is an arbitrary action and thus unconstitutional.
18) American Dental Association denies accountability for representations of safety, and omissions of material fact, concerning products they contend are safe for insertion in a person’s mouth
a) In the California case of Tolhurst v. Johnson & Johnson, the American Dental Association argues to the Court, and is dismissed from liability for its omissions of material fact and its claims of safety for a classification of product it promotes, on the grounds that ADA is a trade association with no duty of care to the general public.
b) You know, or with reasonable care should know, that attributing authoritative claims of safety and effectiveness or a denial of existing evidence without disclosure that such statements are not intended to be reliable representations for which ADA accepts accountability, is a misrepresentation and omission of material fact.
19) Statements of “merely adjusting the concentration of the fluoride ion in water” when applied to hydrofluosilicic acid are misrepresentations and omissions of material fact
a) Hydrofluosilicic acid in its commercial form is only approximately 23% concentration, and the “as fluorine” portion only approximately 17%, meaning that to achieve a concentration of fluoride ion from this product, approximately 6 times the hydrofluosilicic acid must be added, including 6 times the attendant contaminants, such as arsenic, lead, cadmium, mercury, beryllium and other contaminations of the phosphate ore source.
b) You know, or with reasonable care should know, that statements referring to there not being any difference between fluoride concentrations that are found naturally in water and fluoride concentrations achieved by the purposeful addition of a fluoridation chemical are an omission of material fact.
c) Water conditions that provide higher concentrations of a fluoride ion also contain other naturally occurring elements in higher concentrations as well, such as naturally occurring calcium or magnesium or other elements that mitigate the effects of the fluoride alone. The artificial addition of fluoridation chemicals does not contain these other elements.
d) You know, or with reasonable care should know, that statements of “merely adjusting” fluoride content omits that the process includes the addition of significant concentrations of other contaminants.
e) You know, or with reasonable care should know that the legislative intent of the public policy is not to treat the water, but to treat humans.
20) Misrepresenting the presence of contaminants in hydrofluosilicic acid
a) Statements that all contaminants are removed from hydrofluosilicic acid before delivery to water suppliers is a misrepresentation of material fact. The American Water Works Association provides an information list of contaminants in hydrofluosilicic acid as:
Antimony, Arsenic, Barium, Beryllium, Cadmium,
Copper, Lead, Mercury, Selenium, Thallium, and
Radionuclides.
b) A declaration of the exact presence and concentrations of individual contaminants in a product is a requirement of ANSI/NSF Standard 60 as published and adopted by the State of California. This Notice asserts that Crescent City and each of its responsible agents have a duty to determine the exact contents and impurities.
21) Misrepresenting the significance of contaminants present in fluoridation chemicals
a) While reporting requirements allow a detection limit that considers difficulty in making accurate measurements of existing contaminants in source water, a report of “non-detection” of a substance does not indicate that the substance is not present or that it is not present in some amount significant to health.
b) You know, or with reasonable care should know, that a manufacturer’s raw product CAN be reliably measured in its pre-diluted stage and calculated for contribution of its known contaminants, and then assessed for the contribution’s risk of adverse health effects.
c) Cloaking the occurrence of significant concentrations of contaminants behind statements of non-detection after dilution is an omission and misrepresentation of material fact when a contaminant’s concentration can be derived from assessment of the raw product, and the relevance of the statement of non-detection is not disclosed.
d) Appropriate analyses of the product delivered requires full disclosure of the Product Review Data that the manufacturer is required to submit to NSF International to meet Standard 60 as required by California law.
22) Specific misrepresentations and omissions of material facts about the significant concentrations of arsenic in hydrofluosilicic acid
a) In the NSF response to Congressional investigation by the House Committee on Science, NSF International reported an “acceptable” sample of 1.66 parts per billion arsenic contamination of hydrofluosilicic acid after dilution at the manufacturer’s declared Maximum Use Level. This concentration represents a lifetime risk of lung/bladder cancer of more than 1 person per 1000.
b) After the U.S. EPA lowered the enforceable remediation point (MCL) for arsenic from 50 ppb to 10 ppb, NSF began to certify a product that would result in 1 ppb arsenic concentration after dilution. The data presented by the NRC Report on Arsenic that prompted the lowering of the U.S. MCL for arsenic calculates that one person in 1500 will risk lung/bladder cancer because of the addition of hydrofluosilicic acid with arsenic concentrations at 1 ppb.
c) Reporting these risks as non-detected or representing them as non-significant is a misrepresentation of material fact.
d) To put this into perspective, when utilizing the EPA’s normal methodology and calculating for lung/bladder cancer, the California EPA assessed the incidence of lung/bladder cancer at one person per million as 4 parts per trillion of arsenic ingested in water over a lifetime. Every part per trillion or part per billion above this point increases the adverse effect.
e) You know or with reasonable care should know that a statement that arsenic is only in trace amounts or not detected after dilution of the product is a misrepresentation of significance health consequences.
23) Misrepresenting the mechanism by which fluoride can provide dental benefit; no significant benefit from ingestion
a) The theory of the mechanism by which fluoride may benefit a reduction in tooth decay has now been corrected and clarified in the cover story of the July 2000 Journal of the American Dental Association (JADA) and the CDC August 17, 2001 MMWR, in which both declared that there is no significant reduction in tooth decay from the mechanism of ingested fluoride, including any relevant contribution from glandular saliva following ingestion of fluoridated water.
i. JADA: "The fluoride incorporated developmentally–that is, systemically into the normal tooth mineral–is insufficient to have a measurable effect on acid solubility {tooth decay}."
ii. CDC MMWR: “The prevalence of dental caries in a population is not inversely related to the concentration of fluoride in enamel, and a higher concentration of enamel fluoride is not necessarily more efficacious in preventing dental caries.”
24) There are no populations in California or in Crescent City that do not have sufficient access to fluoride through readily available processed foods, beverages, and produce.
a) You know or should know with reasonable care that bio-absorbable fluoride’s are present in significant concentrations in fruit juices; teas; reduced-fat milks; cereals; mechanically de-boned chicken, fish and lunchmeats; and produce, such as citrus fruits, grapes, raisins, lettuce, potatoes, tomatoes, tomato paste, and cabbage — frequently because of allowable high levels of sodium aluminum fluoride (Cryolite) pesticide residues in non-organic products; and in nuts and other products subject to fumigation with Sulfuryl fluoride (Vikane).
b) There are no studies identifying a population or income group that does not have sufficient and economic access to fluoride-containing products. A significant percentage of children in non-fluoridated communities already suffer from over-exposure to fluorides from other-than-water sources.
25) Failure to inform that ingestion of 1 liter of fluoridated water per day increases fluoride dosage over currently allowable prescriptions for children and the EPA Reference Dose (RfD) for fluoride.
a) You know or with reasonable care should know that the increased concentrations of the fluoride ion in the drinking water delivered from the City will result in a higher expected dosage of fluoride to children under 6 years of age than their family doctor can now prescribe in a non-fluoridated community as a substitute for fluoridated water.
b) Current limitations on prescription dosages of fluoride per day are: none for infants; 0.25 mgs for 6 months of age to 3 years – equal to one cup of fluoridated water; and 0.5 mgs for children 3 to 6 years of age – equal to only two cups of fluoridated water.
c) The Integrate Risk Information System (IRIS) Reference Dose (RfD) for fluoride is 0.06 mg/kg/day
d) Failure to inform that the expected dosage from the addition of hydrofluosilicic acid will exceed the RfD of fluoride for a significant percentage of children is a misrepresentation and omission of material fact.
e) Representations that critics of the use of hydrofluosilicic acid merely “claim” that some children will receive excessive dosages as a result of water fluoridation is a misrepresentation and omission of material fact, as the incidence of dental fluorosis is markedly higher in fluoridated communities than non-fluoridated communities.
f) A graphic presentation by Kathleen Thiessen, PhD, of SENES Oak Ridge, Center for Risk Analysis and an author of the 2006 National Research Council Report on Fluoride showing the overdose and evidence of adverse effects corresponding to exposures less than expected from fluoridated water alone has been presented to the City Council and each of the recipients of this Notice.
26) Failure to comply with U.S. Safe Drinking Water Act requirements for Consumer Confidence Reports
a) Should you inject a hydrofluosilicic acid additive into the drinking water supply, you know, or with reasonable care should know, the failure of the City and each of you as Learned Intermediaries to disclose on annual water quality reports the material fact that a source of arsenic or other contamination in the water is the product you have selected, is not in compliance with the U.S. Safe Drinking Water Act requirement for Consumer Confidence Reports.
27) Misrepresenting the dangers, and specific failures to warn
a) You know, or with reasonable care should know, that recipients of public drinking water are captive consumers in that the water is delivered to the consumer’s home with assurances of safety. Without warning of material facts, including the consequences of dermal exposures, the consumer does not have the information to consider whether abandoning the water supply, re-treating their specific water supply, or otherwise protecting themselves from harm, is necessary or appropriate.
b) You know, or with reasonable care should know, that susceptible populations – including the elderly; populations that are deficient in calcium, magnesium, and Vitamin C; and those with kidney, diabetes or heart ailments — and the effects of susceptibility, are already identified in government scientific literature, including the Agency for Toxic Substances Disease Registry (ATSDR) and the December 2006 NRC Report on Fluoride. Nondisclosure by the City and responsible parties in the chain of delivery of hydrofluosilicic acid by not revealing the existence of this information does not allow the consumer the opportunity to assess whether the product consumed is safe for their specific health conditions, and constitutes a specific failure to warn.
c) Blanket denials of the existence or relevance of evidence of harm that can occur from consumption of water containing hydrofluosilicic acid and its contaminants, from dosages received from water alone, or in combination from other sources, are misrepresentations and omissions of material fact.
d) Nondisclosure that any statement of safety is based on limited consumption of water containing hydrofluosilicic acid and its contaminants is a misrepresentation and omission of material fact.
e) Denial of warning to parents of an infant’s susceptibility to dental fluorosis if water containing hydrofluosilicic acid is mixed with infant formula constitutes a negligent failure to warn.
28) Insufficiency in public warning
a) Attempts to evade public disclosure consistent with the universality of exposure to public water for drinking and bathing by providing information and warnings that are accessible only after the economic burden of owning or using a computer to check the City’s web site, or consulting a health professional for that specific purpose, or initiating communications with a protective agency, can hardly be deemed sufficient when the stated purpose of delivering a fluoridation chemical through the public water system is that the target recipients are the indigent and those that do not have economic access to a health professional.
b) Providing notice at the initiation of fluoridation does not adequately inform parents of newborns who may not have anticipated any interest, or new residents, and constitutes a failure to properly warn.
29) Willful, wanton, or gross negligence
a) We also hereby provide formal notice to the City, and each responsible party, as the water operator and Learned Intermediary delivering a purchased product for delivery to constituents, that any actions or omissions that do not heed these aforementioned violations of code and misrepresentation or omissions of material fact may expose the water operator to liabilities for which you as a responsible party may not have provided adequate disclosure of known or reasonably anticipated risks to financial auditors for the purpose of establishing appropriate credit ratings, or securing adequate insurance coverage to cover the breadth of potential claims.
b) Failure to address the risks inherent in noncompliance with state law in a timely fashion, and omissions of your disclosure, may constitute conduct amounting to willful, wanton, and gross negligence.
30) Personal liability
With this Actual and Constructive Notice, any future failure to address the risks inherent in noncompliance with State law in a timely fashion, and omissions of disclosure, may trigger exceptions to the normal hold-harmless protections of individuals acting in a governing body’s behalf.
Summary
This Actual and Constructive notice provides you with statements of fact concerning the selection, administration, and dissemination of information concerning hydrofluosilicic acid and its contaminants; apprises you of misrepresentations and omissions; clarifies authority and acceptance of liability; informs you of unlawful activity and noncompliance with California regulations including entering into a contract for funding that misrepresents obligations and ability to perform; and informs you of the risk of your ignoring your own responsibilities for effecting corrective action.
The City of Crescent City, the City Council, and responsible parties collectively and individually, have the right, and we suggest the duty, to confirm the factual representations herein, but this Notice hereby asserts that from this point forward that you know or with reasonable care should know of the facts set herein before you, and that any further actions that you may effect, including any inquiry that a prudent person may institute, or not institute, to confirm statements made herein, are deemed to be performed with this knowledge.
You should be reminded that Crescent City is required to meet ALL State local and federal laws, without abrogating your duties to the people of Crescent City. As a reminder that the interests of the State and the City of Crescent City extend beyond fluoridation regulations:
A. The California State Legislature has found anddeclared, “Every citizen of California has the right to pure and safe drinking water.” (Drinking Water Statutes, Part 12, Chapter 4, Article 1, §116270 (a))
B. “It is the policy of the state to reduce to the lowest level feasible all concentrations of toxic chemicals that when present in drinking water may cause cancer, birth defects, and other chronic diseases.” (DWS, Part 12, Chapter 4, Article 1, §116270 (d))
C. “It is the further intent of the Legislature to establish a drinking water regulatory program within the State Department of Health Services in order to provide for the orderly and efficient delivery of safe drinking water within the state and to give the establishment of drinking water standards and public health goals greater emphasis and visibility within the state department.” (DWS, Part 12, Chapter 4, Article 1, §116270 (g))
D. “It is the intent of the Legislature to improve laws governing drinking water quality, to improve upon the minimum requirements of the federal Safe Drinking Water Act Amendments of 1996, to establish primary drinking water standards that are at least as stringent as those established under the federal Safe Drinking Water Act, and to establish a program under this chapter that is more protective of public health than the minimum federal requirements.” (DWS, Part 12, Chapter 4, Article 1, §116270 (f))
Respectfully, on June, 03, 2011
I was so amazed to discover this newspaper dedicated to eradication of hydrofluosilic acid added to drinking water.
What an inspiring article re: Notice of collective and individual non-compliance……… etc, dated June 3, 2011. Can you please give me the name of the author? I was blown away with that whole presentation. I think that City Councils all over North America are shaking in their boots. I have forwarded it to the Toronto Chapter of “Citizens for a safe environment”, and “End Fluoride Toronto” and they were as impressed as I was. I think that if Toronto City Council were presented with that article they might have second thoughts on their responsibility to fluoridate. Hoping to hear from you. I look forward to reading more articles in your newspaper.
The only thing left is to go to trial!