Letter to US FDA re: Water fluoridation and lead

Dr Richard Sauerheber

Palomar College

San Marcos, CA 92069

June 20, 2016

U.S. Food and Drug Administration (FDA)

Center for Drug Evaluation and Research

Rockville, MD 20857

Dear FDA reviewers of petition FDA2007-P-0346

This letter further clarifies previous information sent to the FDA on the issue of water fluoridation and lead, Pb, contamination. The private organization the National Sanitation Foundation has now released its 2015 updated version of regulations on the addition of chemicals into public drinking water supplies in the U.S. The document states that no additive can be added into public water to a final diluted level in the product water in excess of 10% of the EPA allowed MCL for that substance. (An exception however has long been made for fluoride, as an oral ingestible dental prophylactic, since the recommended use level remains 1 ppm which is 25% of the EPA MCL for fluoride of 4 ppm).

There is a new problem now that has surfaced and is related to a highly publicized issue in Flint, MI where blood levels of lead in children have become elevated due to very high levels of lead-leeching chloramines in the Flint River. The NSF ANSI 60 regulations clearly state that water additives cannot cause lead ion in the final product water to be above 10% of its EPA MCL of 15 ppb. Of course fluoridation of Flint in the above conditions would be in violation of NSF regulations. But just as important, this proves, unbeknownst to the NSF and the EPA, that it is not permissible to add fluosilicic acid to most of the water supplies in the U.S. This is because lead contamination is added, when fluosilicic acid is infused to adjust fluoride to 1 ppm, at typically 1.2 ppb additional lead (see data by Mullenix submitted to the FDA June 5, 2014). So any water supply that already has 0.3 ppb lead (and most do in the U.S.) cannot be allowed to fluoridate. The presence of 0.3 ppb plus the added 1.2 ppb total 1.5 ppb, which is 10% of the EPA MCl for lead.

Conclusion: Water districts and public health officials, the EPA, the FDA, etc. need to be alerted to the fact that any water supply with over 0.3 ppb lead cannot be fluoridated under NSF ANSI 60 2015 guidelines with fluosilicic acid materials. This is an intrinsic problem with using fluocilicic acid and, as previously mentioned, is in addition to the lead-leeching caused by the silicic acid byproduct that fluoridation also produces (see June 5, 2014 letter). The FDA could help us with this notification, that certification by NSF must be withdrawn for fluosilicic acid used for fluoridation, or that certification must be accompanied with statements that any water supply with lead above 0.3 ppb cannot use fluosilicic acid materials for fluoridation. The NSF now is playing the role that only the FDA is supposed to have, where NSF is certifying batches of fluoride compounds intended for ingestion, with the assumption the added fluoride ion is an oral ingestible dental prophylactic, all without FDA involvement or permission.

Thank you.

Richard Sauerheber, Ph.D. Chemistry