JAMES ROBERT DEAL ATTORNEY PLLC
PO Box 2276, Lynnwood, Washington 98036-2276
Telephone 425-771-1110, Fax 425-776-8081
June 6, 2012
REQUEST FOR ADVICE FROM CITY ATTORNEY
James D. Iles, City Attorney
2930 Wetmore Ave. Ste. 10-C
Everett, WA 98201
Sent by fax to: 425-257-8693
Sent by email to: firstname.lastname@example.org
Dear Mr. Iles,
On Tuesday April 9, 2012, Everett Utilities resumed fluoridation after a two month hiatus. The City Council met on Wednesday, April 10, 2012, when the decision not to prevent Everett Utilities from restarting was discussed.
After the meeting I talked with Assistant City Attorney Ramsay Rammerman. Ramsay said something I disagree with. We were discussing the NSF 60 mark of approval for fluorosilicic acid and whether Everett can rely on it as proof of safety.
In documents which I have previously submitted to you we have explained how The National Sanitation Foundation fits into the fluoridation picture. NSF is a chemical company trade association, funded by EPA to certify fluoride as safe and to approve its use. Some board seats are filled by representatives from the industries regulated. Some 47 states require that only NSF 60 fluoride be used, including Washington. WAC 246-290-220(3), says: “any treatment chemicals … added to water intended for potable use must comply with ANSI/NSF Standard 60. The NSF web site and the NSF Standard for Drinking Water Additives, say: “Standard 60 … requires a toxicology review to determine that the product is safe at its maximum use level and … to determine if any contaminant concentrations have the potential to cause adverse human health effects. …” However, NSF official Stan Hazan admitted under oath in deposition that toxicological studies are not being done. (See Hazen deposition, pages 22, 67). Thus fluoridation materials do not “comply” with NSF 60 and fluoridation with them is illegal.
Ramsay said that the City could rely on the NSF 60 mark as proof of safety and that the City was not obligated to inquire further into the safety of the fluorosilicic acid. I believe this advice is incorrect. Note that WAC 246-290-220(3 does not say “sports the NSF 60 mark”. The regulation says that the fluoridation materials “must comply with ANSI/NSF Standard 60”. The materials do not comply and therefore may not legally be used to fluoridate.
I would grant that it would be true that the City could rely on the NSF 60 mark if no reason for concern about compliance had been raised. However, when convincing evidence is presented that Simplot fluorosilicic acid does not comply with NSF 60, a threashhold is passed. The City has a duty to inquire further. I am asking that you correct the erroneous advice you gave to the City Council.
In documents which I have previously submitted to you we have explained that the use of fluorosilicic acid for fluoridation materials is illegal is that it contains hydrogen fluoride. An FDA regulation at 21 CFR 310.545 prohibits the marketing and sale of any anti-caries drug which contains hydrogen fluoride unless the the seller has first filed an FDA new drug application (NDA) and received FDA approval.
Said federal regulation list many elements and compounds, including hydrogen fluoride, which require prior approval before marketing. The regulation says of the chemicals on the list:
…based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses.
Then the regulation states:
Any OTC [over the counter] drug product … containing any active ingredient(s) as specified in … this section is regarded as a new drug within the meaning of … the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application … is required for marketing.
Fluoride used for water fluoridation contains HF and therefore should not be utilized until prior approval has been obtained from the FDA. I am asking that you advise the City Council, based on this legal reasoning, that a moratorium on fluoridation would be the wise thing for Everett to do.
I sent a letter to Simplot dated February 2, 2012. Simplot has not responded. I am asking you to follow up with Simplot and see to it that Simplot responds. Simplot owes Everett an explanation and an apology.
I have prepared a letter to NSF dated June 5, 2012. I am asking you follow up with NSF and urge NSF to respond. The NSF owes Everett an explanation and an apology.
I am attaching a proposed resolution for the City Council to consider. I am asking you and Ramsey Rammerman to switch sides on this issue and advise the City Council to impose a moratorium on fluoridation.
James Robert Deal, Attorney WSBA # 8103