BEFORE THE GOVERNOR
STATE OF WASHINGTON
James Robert Deal, Attorney on behalf of Fluoride Class Action,
Re: Washington State Board of Health 11-2-15 Denial of Petition for Rule Making
BRIEF IN SUPPORT OF MOTION FOR RECONSIDERATION
COMES NOW Fluoride Class Action, acting by and through its attorney, James Robert Deal, this Brief in Support of Motion for Reconsideration of the decision by the Governor dated January 7, 2016.
All the links in this document can be accessed at www.fluoride-class-action.com/governor-inslee-1-20-2016.
RCW 34.05.330 requires that when an agency denies a petition, the agency response should state “… its reasons for the denial, specifically addressing the concerns raised by the petitioner …”. RCW 34.05.330 also says that when a petitioner appeals a denial to the Governor that the Governor shall state “… his or her reasons for the denial, specifically addressing the concerns raised by the petitioner…”.
This brief will show that the decision of the Governor dated January 7, 2016, failed to address all the issues presented by Fluoride Class Action in its brief dated December 1, 2015.
The Governor’s response dated January 7, 2016, said:
Essentially, your proposed amendment would prohibit the use of fluoridation additives in community water systems until the Board conducts a quantitative risk assessment of the type conducted or obtained by NSF-an international product testing, inspection, and certification organization-and reasonably determines that fluoride additives comply with NSF/ANSI Standard 60, an internationally recognized drinking water health standard. But as the Board stated in its denial of your petition, NSF/ANSI Standard 60 provides that when the U.S. Environmental Protection Agency has finalized a Maximum Contaminant Level or other means of regulation, “no additional collection of toxicological data shall be required.” Fluoride, which has its own MCL, falls under this part of the standard, and thus is not subject to further collection of toxicological data. And, the toxicology studies that you reference in your petition are designed for other, non-regulated substances. Your petition misconstrues the NSF/ANSI Standard 60 requirements and errs in concluding that fluoride additives do not meet the standard. For these reasons, I see no reason to overturn the Board’s decision.
WAC 246-290-220 says that fluoridation may be done in Washington only with fluoridation materials which “comply with” the National Sanitation Foundation NSF Rule 60 standard. NSF 60 requires that some 20 toxicological studies be done. The November 9, 2015, Board of Health denial of the September 3, 2015, petition of Fluoride Class Action contains an implied admission that the 20 toxicological studies required by WAC 246-290-220 and by NSF 60 are not being done. The Governor’s January 7, 2016, contains the same implied admission. However, both the Board and the Governor claim that these toxicological studies are not required under NSF 60 because it states that when the U.S. Environmental Protection Agency has finalized a Maximum Contaminant Level or other means of regulation, “no additional collection of toxicological data shall be required.”
The Board and the Governor ignore the fact that even if the toxicology studies are not required, NSF 60 and therefore WAC 246-290-220 still require that a risk estimation test must still be done. Even if the EPA has set an MCL for fluoride and for the other contaminants in the fluorosilicic acid mixture, and even if the toxicological studies are waived, the risk estimation test in Section A.6.1 is not waived and must still be done.
Fluoridation at .7 ppm fails the risk estimation test because the SPAC [single product allowable concentration], must be set at a level no greater than ten percent of the EPA MCL. The EPA MCL is 4 ppm, and ten percent of 4 ppm is .4 ppm. Fluoridation at .7 ppm exceeds the NSF 60 .4 ppm SPAC.
Further, calculation of the SPAC takes into account the number of other sources of fluoride other than drinking water fluoridation. There are other sources of fluoride such as foods and beverages made using fluoridated water; common fruits, grains, and dried bulk products sprayed with sulfuryl fluoride; the many fluorinated drugs such as Prozac; and finally fluoridated toothpaste, which is absorbed through mouth tissues and swallowed.. Therefore, the SPAC is less than .4 ppm, even further from the .7 ppm level which has been approved by the Board of Health.
The decisions of the Board and the Governor fail to take into account the fact that the current text of A.2.3 which includes a blanket waiver for doing toxicological studies for all additives or contaminants for which there is an EPA MCL differs from the original 1988 edition of NSF 60, contained no such blanket waiver.
The decisions of the Board and the Governor fail to take into account the fact that it makes no sense for NSF 60 to say that 20 toxicological studies must be done but then to include a sentence which says they will, in effect, always be waived. Therefore, the blanket waiver is inconsistent with the rest of NSF 60 and must be considered to be void.
The decisions of the Board and the Governor fail to take into account the fact that 2009 version omits the previous sentence from the 1988 version:
“Prior to initiating new toxicity testing, the applicant is strongly encouraged to discuss information requirements and test protocols with the certifying agency.”
The decisions of the Board and the Governor fail to take into account the fact that the NSF’s 2008 Fluoride Fact Sheet does not contain any such waiver language and says:
Standard 60 was developed to establish minimum requirements for the control of potential adverse human health effects from products added directly to water during its treatment, storage and distribution. The standard requires a full formulation disclosure of each chemical ingredient in a product. It also requires a toxicology review to determine that the product is safe at its maximum use level and to evaluate potential contaminants in the 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. 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 developed a testing and certification program for these products, so that individual U.S. states and waterworks facilities would have a mechanism to determine which products were appropriate for use. The certification program requires annual unannounced inspections of production and distribution facilities to ensure that the products are properly formulated, packaged, and transported with safe guards against potential contamination. 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 use of this standard and the associated certification program have yielded benefits in ensuring that drinking water additives meet the health objectives that provide the basis for public health protection. … The NSF toxicology review for a chemical product considers all chemical ingredients in the product as well as the manufacturing process, processing aids, and other factors that have an impact on the contaminants present in the finished drinking water. This formulation review identifies all the contaminants that need to be analyzed in testing the product. For example, fluosilicic acid is produced by adding sulfuric acid to phosphate ore. This is typically done during the production of phosphate additives for agricultural fertilizers. The manufacturing process is documented by an NSF inspector at an initial audit of the manufacturing site and during each annual unannounced inspection of the facility. The manufacturing process, ingredients, and potential contaminants are reviewed annually by NSF toxicologists, and the product is tested for any potential contaminants. A minimum test battery for all fluoridation products includes metals of toxicological concern and radionuclides.
The NSF’s 2012 Fluoride Fact Sheet says almost the same thing. These NSF fluoride Fact sheets are proclamations by NSF 60 made to the general public and therefore are either incorporated into NSF 60 or serve to show that the blanket waiver inserted into NSF 60 must be disregarded. The NSF 60 document has not been available online to the public until recently, while the NSF 60 book costs $325 and is generally only seen by water districts. It is black letter law that fine print disclaimers cannot un-warrant what the large print warrants. The large and public print says there will be toxicological studies, testing, and safety of the product. Again, the “no additional collection of toxicological data shall be required” language is invalid. The decisions of the Board and the Governor fail to take this into account.
In another document on its web site NSF represents that it has two toxicologists on staff, a further indication that NSF does toxicological tests. NSF would not have toxicologists on staff if all toxicological tests are waived. This is a further indication that the blanket waiver language is void. The decisions of the Board and the Governor fail to take this into account.
Section A.2.3 of NSF 60 wrongly interprets the EPA’s National Primary Drinking Water Regulations and the EPA’s MCL for fluoride, which is 4.00 ppm. The SDWA requires removal of fluoride if it exceeds 4 ppm. It does not authorize adding fluoride up to the 4 ppm level or adding any fluoride at all.
The highly respected National Research Council explains this at NRC 2006, Page 1:
“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] 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.
Further, NRC 2006, Page 13, says:
It is important to make the distinction that EPA’s standards are guidelines for restricting the amount of naturally occurring fluoride in drinking water; they are not recommendations about the practice of adding fluoride to public drinking-water systems.
Thus, the broad waiver language inserted into NSF 60 attempts to use the EPA MCL to authorize addition of fluoride up to ten percent of the EPA MCL, a use of the MCL not intended by Congress when it passed the EPA Act. The decisions of the Board and the Governor fail to take this into account>
This becomes more clear when you look a the list of contaminants regulated by EPA. Notice that the list includes biological contaminants such cryptosporidium. This is clearly not an authorization to add cryptosporidium up ten percent of the EPA MCL but a requirement to remove it if it is present above the MCL or prohibit its addition to water.
Notice that the EPA list includes such man made toxic waste chemicals such as atrazine. The MCL and MCLG for atrazine is .003 ppm, which equals 3 ppb. This is clearly not an authorization to add atrazine up to 3 ppb but to require its removal from water if it exceeds that level or to prohibit its addition to water.
The type of fluoride referred to in the EPA MCL and MCLG list is “naturally occurring fluoride”, not man-made fluorosilicic acid intentionally added. This is what the National Research Council said, as noted above. See NRC 2006, Page 13:
It is important to make the distinction that EPA’s standards are guidelines for restricting the amount of naturally occurring fluoride in drinking water….
There is a big difference between naturally occurring calcium fluoride and the man-made forms. Calcium fluoride is the naturally occurring fluoride found most frequently. Calcium binds to fluoride and neutralizes it. Calcium fluoride is not as immediately poisonous as is fluorosilicic acid. The LD 50 for calcium fluoride is 3,750 mg/kg; for fluorosilicic acid it is 125 mg/kg.
For a 70 kilogram or 154 pound person it would take a quarter kilogram of calcium fluoride to kill 50 percent of us – while making the rest very ill. For fluorosilicic acid the LD50 for a 70 kilogram person would be only 8.7 grams, the weight of around eight 1.25” paper clips. Also, calcium fluoride does not leach lead from plumbing, whereas fluorosilicic acid does.
This is additional evidence that the broad waiver language inserted into NSF 60 is void.
The decision of the Board and the Governor fail to take into account the fact that Section A.3.2 is poorly worded, even nonsensical. A.3.2 says:
“If a substance is regulated under the USEPA’s National Primary Drinking Water Regulations and USEPA has finalized a Maximum Contaminant Level (MCL) or other means of regulation such as a treatment technique (see Annex A, Section A.2.18) no additional collection of toxicological data shall be required prior to performance of the risk estimation.”
What the amateurs who wrote A.3.2 were trying to say is:
“If a substance is regulated under the USEPA’s National Primary Drinking Water Regulations and USEPA has finalized a Maximum Contaminant Level (MCL) or other means of regulation such as a treatment technique (see Annex A, Section A.2.18), and if the MCL does not exceed 10% of the MCL set by the USEPA, no additional collection of toxicological data shall be required ….
The fact that this paragraph is nonsensical is further evidence that the entirety of A.3.2 should be disregarded and that the toxicological studies must be done.
The Board and the Governor fail to take into account the fact that compliance with A.2.3 is not enough for fluoridation materials to “comply with” NSF 60. The supplier of fluoridation materials and NSF must also “comply with” NSF 60-2013 section 3.2.1, which says:
3.2.1The 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;
–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;
– a list of known or suspected impurities within the treatment chemical formulation and the maximum percent or parts by weight of each impurity; and
– the source and type of water used in the manufacture of the treatment chemical as well as any available documentation regarding quality monitoring of such water source, if applicable;
– 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 required by Annex A a list of published and unpublished toxicological studies relevant to the treatment chemical and the chemicals and impurities present in the treatment chemical.
The most interesting of these is the last one, which says the supplier must supply:
a list of published and unpublished toxicological studies relevant to the treatment chemical and the chemicals and impurities present in the treatment chemical.
That would include the fluoride itself and the other contaminants that come along with it.
The toxicological studies must be “relevant”, and they must be real toxicological studies. Both published and unpublished studies must be submitted. The requirement that unpublished studies be submitted would imply that the supplier is required to commission studies.
If they were complying with NSF 60, suppliers should have submitted all these documents to NSF when they applied for NSF certification of their so-called fluoride. And NSF should have received these documents. So both the suppliers and NSF should have these documents.
If the documents from the suppliers are not in good order or were never submitted (which is almost certainly the case), then the fluoridation materials we use to pollute our drinking water would not “comply with” NSF 60.
The decisions of the Board and the Governor fail to take into account the fact that NSF 60 does not apply only to fluoride. It applies to other contaminants that come with fluorosilicic acid, such as arsenic.
NSF admits that around 43% of all fluorosilicic acid batches contain some arsenic and that the maximum amount of arsenic added to water which was fluoridated at 1.0 ppm was 1.66 ppb as documented by NSF in 2000. Arsenic is a confirmed type 1A human carcinogen. In 2001 the EPA lowered the MCL for arsenic from 50 ppb to its current level of 10 ppb.
With water now fluoridated at .7 ppm instead of 1.0 ppm, the effective level of arsenic added by the fluoridation materials would be 1.66 ppb x .7 = 1.16 ppb, which is more than 10% of the 10 ppb MCL. Arsenic from fluorosilicic acid added to water at .7 ppm fails the risk estimation test. Further, bear in mind that as with fluoride, if there are sources of arsenic ingestion other than from drinking water, the denominator in the NSF formula should be raised from 1.0 to a higher number, which would lower the SPAC and make it less likely that arsenic would pass the risk estimation test.
The Board and the Governor fail to take into account the fact that the amount of lead contained in fluorosilicic acid and added to drinking water can add 1.1 ppb according to a 2000 NSF report and.6 ppb according to the 2008 and 2012 NSF Fluoride Fact Sheets when water is fluoridated at 1 ppm fluoride.
The EPA MCL for lead is 15 ppb. Now that the level of added fluoride has been lowered from 1.0 to .7 ppm, fluorosilicic acid is being diluted 328,000 times instead of 230,000 times to reduce the fluorosilicic acid concentration to .7 ppm instead of 1.0 ppm. The amount of lead being contributed along with the so-called fluoride we drink at .7 ppm would be 70% of 1.1 ppb or .77 ppb. A mechanical application of the “no additional collection of toxicological data shall be required” language in the current version of NSF 60 would say that lead passes the risk estimation test when water is fluoridated at .7 ppm – because.77 ppb is under 10% of the 15 ppb MCLG. Likewise, toxicological studies would not be required simply because there is an MCL for lead.
However, the “no additional collection of toxicological data shall be required” language is void for reasons discussed above in the context of fluoride.
And as with fluoride, the fact that there is a 15 ppb MCL for lead is not an authorization to add any amount of lead, only to remove lead if it exceeds the MCL action level or to prevent the addition of lead to water if the amount added from pollution exceeds that action level.
Further, there are other sources of lead in the environment, and this changes the calculation under the risk estimation test. There is lead paint in older homes. There is lead in old service lines running out to the street, in brass faucets up to 8.0%, in copper-lead solder, in soil as a result of burning gasoline containing tetraethyl lead from the 1920s into the 1980s, and from piston engine aircraft which still burn leaded avgas. Therefore, the denominator in the NSF formula to run the risk estimation test should be raised from 1.0 to a higher number, which would lower the level at which lead passes the risk estimation test. And of course, toxicological studies should be required because the “no additional collection of toxicological data shall be required” language is void.
Further, the decision of the Board and the Governor fail to take into account that Fluorosilicic acid not only contains lead, it leaches lead from plumbing. In 1992 Tacoma was fluoridating city water with fluorosilicic acid. The percentage of homes in Tacoma exceeding the action level for fluoride – then 50 ppb – was 9.8%. Because Tacoma was experiencing equipment problems and a drought, Tacoma Public Utilities stopped fluoridating temporarily. When fluoridation stopped, 90th percentile lead levels dropped from 32 ppb to 17 ppb. The 90th percentile test means that 10% of randomly selected homes had lead coming from their taps at 32 ppb and then 17 ppb. Also in 1992 Thurmont, Maryland, stopped fluoridating. Lead levels in Thurmont dropped 78%. Thurmont turned off the fluoridation equipment permanently. Tacoma soon returned to fluoridating.
Lead leaching can be extreme. In 2004 Seattle papers reported lead at 1,600 ppb (parts per billion) in old Seattle schools, far above the 15 ppb EPA action level and the zero ppb goal. New brass pipes and faucets contain around 8% lead and older pipes contain as much as 30% lead. Old schools, homes, apartments, hospitals, office buildings, and factories have pipes containing lead, which silicic acid will leach. When water districts stop fluoridating, lead levels in water and in blood drop, as happened in Tacoma in 1992. Seattle commissioned reports on the lead in schools, but had a blind spot to the possibility that silicic acid was a factor.
Fluorosilicic acid, when dissolved in water down to 1.0 ppm fluoride or now down to .7 ppm fluoride, breaks down into fluoride ion, hydrogen fluoride, and silicic acid, H4SiO4, as confirmed in the 2006 National Research Council study on fluoride at page 53. Even though there is relatively little lead in water in the water mains, even including the lead which came along with the fluorosilicic acid, lead levels at the tap can be much higher. It is the silicic acid which dissolves lead in plumbing.
Coplan, Masters, Maas, and Sawan (cited in my appeal to the Governor) showed that that there is much more lead in tap water fluoridated with fluorosilicic acid than with sodium fluoride. Silicofluoride, more so than sodium fluoride, leaches lead out of pipes and brass fittings.
Silicic acid is classed as a weak acid and is often dismissed as relatively harmless. Unfortunately for our health, it is able to dissolve – slowly but surely – the lead in lead based pipes and fittings and lead-brass faucets. The dissociation constant of silicic acid in water is very low, 2 x10-10. This means that the amount of sodium carbonate, Na2CO3, also known as soda ash, added to neutralize the fluoride ion and hydrogen fluoride is not sufficient to neutralize the silicic acid. Although silicic acid is classed as a weak acid, it is also hard to neutralize and therefore persists and dissolves lead in plumbing.
See Dr. Richard Sauerheber explanation of the process whereby fluorosilicic acid breaks down into silicic acid and then leaches lead (referenced in the Fluoride Class Action appeal to the Governor).
Finally, the Board and the Governor failed to consider the published admissions by the CDC that fluoridation is only marginally effective at best causes dental fluorosis, and is effective only topically if at all, not by consuming it. The admissions are as follows:
a) that fluoridation reduces caries only 18% to 25%;
b) that 41% of adolescents suffer from some degree of dental fluorosis, with around 12% of adolescents suffering from mild, moderate, and severe fluorosis, which is noticeable, embarrassing and ugly; and
c) that “fluoride prevents dental caries predominately after eruption of the tooth into the mouth, and its actions primarily are topical for both adults and children”.
For all these reasons, Fluoride Class Action is requesting that you reconsider your denial of its appeal dated December 1, 2015.
Dated this 20th day of January, 2016.
James Robert Deal, Attorney
Attorney for Fluoride Class Action