April 16, 2013
Parliamentary Commission on Fluoridation in Quebec Attention : Cédric Drouin Sent by email only to : firstname.lastname@example.org
Dear Parliamentary Commission,
I am the president of Fluoride Class Action, an association of attorneys and scientists who study fluoridation law and science and who advise consumer groups and municipalities on this topic.
Today I am writing regarding the fluorosilicic acid still being added to drinking water in some Quebec water districts or cities.
According to Quebec code 184.108.40.206:
Le ministère de la Santé et des Services sociaux (MSSS) s’assure, avant tout octroi de contrat d’approvisionnement, que les produits chimiques utilisés pour la fluoration de l’eau respectent les normes suivantes: … ANSI/AWWA B703 pour l’acide fluorosilicique (77). … Les produits doivent également respecter la norme de qualité très stricte ANSI/NSF Standard 60, mise au point par le National Sanitation Foundation (NSF) conjointement avec un consortium d’organisations dont le AWWA et le ANSI (77) Cette norme, s’applique à tous les produits ajoutés à l’eau potable par les usines de traitement d’eau, et elle établit des concentrations maximales acceptables pour 11 métaux réglementés par l’Environment Protection Agency (EPA) aux États-Unis (p. ex. l’arsenic, le chrome, le plomb, etc.). Pour qu’un produit soit certifié par le NSF selon la norme ANSI/NSF Standard 60, la concentration d’un contaminant, lorsque le produit est dilué dans l’eau, ne doit pas dépasser le dixième de la concentration maximale acceptable (CMA) permise par Santé Canada ou du maximum concentration level (MCL) permis par l’EPA, aux États-Unis.
In English I believe this says:
Before granting any supply contract the Ministry of Health and Social Services (MSSS) must insure that the chemicals used for water fluoridation meet the following standards: … ANSI/AWWA B703 for acid fluorosilicic (77). … Products must also meet the strict quality standard of ANSI/NSF Standard 60, developed by the National Sanitation Foundation (NSF) in conjunction with a consortium of organizations including ANSI and AWWA (77). This standard applies to all products added to drinking water or for treatment of drinking water, and establishes maximum acceptable concentrations for 11 metals regulated by the Environment Protection Agency (EPA) in the United States (eg. arsenic, chromium, lead, etc.) … For a product to be certified by NSF as conforming to ANSI/NSF Standard 60, the concentration of a contaminant, where the product is diluted in water, should not exceed one-tenth of maximum acceptable concentration (MAC) allowed by Health Canada or the maximum concentration level (MCL) allowed by the EPA in the United States.
You may read relevant excerpts from ANSI/AWWA B703 by following this link.
You may read relevant excerpts from NSF 60 by following this link.
Generally, ANSI/AWWA B703 merely incorporates the standards of NSF 60. The major difference between ANSI/AWWA B703 and NSF 60 is that ANSI/AWWA B703 says that additives will be both safe and effective, while NSF 60 only says they will be safe.
A Certificate of Analysis is delivered with each tanker load of fluorosilicic acid. See a typical Certificate of Analysis at this link:
Note that Quebec law requires that all “chemicals used for water fluoridation meet the … strict quality standard of ANSI/NSF Standard 60”. Bearing the NSF 60 mark on the Certificate of Analysis is not good enough. The fluoridation materials must meet the strict quality standards.
Although the typical Certificate of Analysis bears the NSF 60 mark, fluoridation materials do not “meet the … strict quality standard of ANSI/NSF Standard 60”, as I will explain below, and thus do not conform to Quebec law.
The NSF Standard 60 document states the following:
This document has been reviewed by the Office of Drinking Water, U.S. Environmental Protection Agency, and approved for publication. …
This Standard establishes minimum health effects requirements for the chemicals, the chemical contaminants, and the impurities that are directly added to drinking water from drinking water treatment chemicals. …
This Standard contains health effects requirements for drinking water treatment chemicals that are directly added to water and are intended to be present in the finished water. …
The NSF 60 Standard requires a supplier such who wants to receive NSF 60 certification for its fluoridation materials, to provide substantial documentation proving the fluoridation materials to be safe. Fluoridation materials may not be sold in nine Canadian provinces and territories and 47 states unless they meet the NSF 60 standard. See the list of provinces, territories, and states at this link:
I quote again from the NSF 60 Standard:
The manufacturer shall submit, at a minimum, the following information for each product:
a proposed maximum use level for the product which is consistent with the requirements of annex A [annex A is in the excerpts supplied;
complete formulation information, which includes the following:
the composition of the formulation (in percent or parts by weight for each chemical in the formulation);
the reaction mixture used to manufacture the chemical, if applicable;
chemical abstract number (CAS number), chemical name, and supplier for each chemical present in the formulation; and
a list of known or suspected impurities within the treatment chemical formulation,
and the maximum percent or parts by weight of each impurity.
a description or classification of the process in which the treatment chemical is manufactured, handled, and packaged;
selected spectra (e.g. UV/visible, infrared) shall be required for some additive products or their principle constituents; and
when available, a list of published and unpublished toxicological studies relevant to the treatment chemical and the chemicals and impurities present in· the treatment chemical.
The NSF 60 standard requires that some 20 toxicological studies be done:
For each substance requiring a new or updated risk assessment, toxicity data to be considered shall include. but not be limited to, assays of genetic toxicity, acute toxicity (1 to 14 [day] exposure), short-term toxicity (14 to 28 [day] exposure), subchronic toxicity (90 [day] exposure), reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, chronic toxicity (including carcinogenicity), and human data (clinical, epidemiological, or occupational) when available. To more fully understand the toxic potential of the substance, supplemental studies shall be reviewed, including, but not limited to, mode or mechanism of action, pharmacokinetics, pharmacodynamics, sensitization, endocrine disruption, and other endpoints, as well as studies using routes of exposure other than ingestion. Structure activity relationships, physical and chemical properties, and any other chemical specific information relevant to the risk assessment shall also be reviewed.
The supplier of fluoridation materials is required under the NSF 60 standard to prepare and provide all these documents to NSF in order to obtain the right to affix the NSF 60 “Mark” on its fluoridation Certificate of Analysis. Therefore, the supplier must have them on hand. If the supplier did not prepare them – perhaps because NSF waived the requirement – then the supplier’s fluorosilicic acid does not “conform to” the NSF 60 standard and in turn does “conform to” Quebec law.
Please review the 2012 NSF Fact Sheet on Fluoridation Chemicals. It can be found at this link:
The 2012 NSF Fact Sheet states the following:
The NSF Standard 60 was developed to establish minimum requirements for the control of potential adverse human health effects.
NSF/ANSI 60 has been developed to establish minimum requirements for the control of potential adverse human health effects from products added to water for its treatment. …
The standard requires a full formulation disclosure of each chemical ingredient in a product. The standard requires testing of the treatment chemical products, typically by dosing these in water at 10 times the maximum use level, so that trace levels of contaminants can be detected. An 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 of each NSF Certified product. NSF Certified products have the NSF Mark, the maximum use level, lot number or date code and production location on the product packaging or documentation shipped with the product. …
The NSF standard requires that the treatment products added to drinking water, as well as any impurities in the products, are supported by toxicological evaluation.
However, the only toxicological data that the supplier has supplied to the Quebec water districts which fluoridate is the abbreviated information contained within the 2012 NSF Fact Sheet on Fluoridation Chemicals which says:
NSF has compiled data on the level of contaminants found in all fluoridation products that have applied for, or have been listed by, NSF. The statistical results in Table 1 (attached) include the test results for these products, as well as the annual monitoring tests from the period 2000 to 2006. This includes 245 separate samples analyzed during this time period.
Note that NSF is admitting that there is no testing of each batch, but only 245 tests done over a six year period which ended seven years ago. There are around 49 certified suppliers of fluoridation materials in the United States. See the list at this link:
If only 245 tests were done over a six year period, and assuming that each supplier delivered only an estimated 100 tanker loads of fluoridation materials annually, then out of 4,900 batches delivered by the 49 suppliers, only 5% of those batches were tested and presumably are being tested on an ongoing basis.
Moreover, there is evidence which would hold up in a court of law that the suppliers of fluoridation materials are not doing the toxicological studies because NSF is waiving the requirement that they do them. NSF official, Stan Hazen, admitted under oath that toxicological studies were not done or available. See a transcript of a California deposition ( pages 22-25 and page 67) in which Hazan said:
NSF failed to follow its own Standard 60 procedures, and because we had no tox data on the HFS, then that was — we discussed again how the tox — toxicology department fulfills the Standard 60 requirements by relying on the individual MCLs for the — for the different elements within HFSA.
The Stan Hazan deposition can be read by following this link:
There is more evidence that the suppliers are not providing the toxicological studies and that NSF is not requiring them. You can read the detailed proof at this link:
Further, Quebec water districts which fluoridate are failing to fluoridate in accordance with ANSI/NSF Standard 60 requirements by fluoridating at a concentration of .7 ppm, which means they are adding more fluoride to drinking water than is allowed under ANSI/NSF Standard 60, which again says:
For a product to be certified by NSF as conforming to ANSI/NSF Standard 60, the concentration of a contaminant, where the product is diluted in water, should not exceed one-tenth of maximum acceptable concentration (MAC) allowed by Health Canada or the maximum concentration level (MCL) allowed by the EPA in the United States.
The EPA Maximum Contaminant Level for fluoride is 4.0 ppm, and one-tenth of that would be .4 ppm. See:
Likewise, the sixth edition of the Guidelines for Canadian Drinking Water Quality lists a MAC of 1.5 mg/L for fluoride, and one-tenth of that would be .15 ppm. See:
Therefore, Fluoride Class Action recommends that Parliamentary Commission on Fluoridation in Quebec and the water districts which fluoridate their drinking water send a letter to the supplier of fluoridation materials, demanding the following:
1) that the supplier deliver the toxicological studies and other materials which it was required to submit to NSF in order to obtain ANSI/NSF 60 certification to the Parliamentary Commission on Fluoridation in Quebec and to the water districts which fluoridate; and
2) that the supplier demonstrate that the fluoridation materials it supplies “meet the strict quality standard of ANSI/NSF Standard 60” and therefore comply with the requirements of Quebec law.
Fluoride Class Action recommends that if the supplier fails to do this, that the Parliamentary Commission find that the water districts which fluoridate their drinking water should stop adding fluoridation materials to the water until said toxicological studies are delivered.
Further, Fluoride Class Action recommends that the Parliamentary Commission on Fluoridation in Quebec should find that Quebec water districts should comply with NSF 60 standards as they are and reduce the amount of fluoridation materials added to drinking water to the level of .15 ppm.
In your study, please pay attention to the fact that the fluoridation materials contain lead and leach lead from pipes and fittings. Most homes and buildings built to current standards contain some lead in pipes and fittings. Brass pipes and fittings may contain up to 8% lead. Quebec homes and buildings built before 1978 contain a lot of lead, up to 30% lead. As bad as the fluoridation materials are, it may be that the lead which fluoridation materials contain and which the fluoridation materials leach from pipes is even more harmful.
Some uninformed dentists claim that fluoridation is safe and effective, but no one claims that lead is safe and effective. Therefore, the case against fluoridation is easier to prove when the focus is on lead.
For a general overview of fluoridation materials, please read the following documents:
In closing I would simply add, study the facts, do not be satisfied with vague assurances, and listen to your conscience.
James Robert Deal, Attorney WSBA Number 8103
P.S. For your convenience in following links, this document is posted at www.Fluoride-Class-Action.com/Quebec-Parliamentary-Commission.