Dear Ms. Martel,

We ask that you forward this as an "Email" to the chairman and to all the committee members to allow immediate access to the links we cite.

On March 22, 2004, we submitted to US EPA Office of Pesticide Programs, FAN's Objections and a Request for Hearing on the Final Rule that approved the use of sulfuryl fluoride as a fumigant on food commodities. This submission is available at http://www.fluoridealert.org/epa-sf.htm

Of particular interest to committee members-

First, we highlighted the many inadequacies with EPA's safe drinking water standard for fluoride (the 4 ppm MCL). We felt compelled to analyze this standard since EPA's risk assessment underpinning their approval of Dow's request is entirely predicated on this standard's legitimacy. To see our discussion of this standard, see: http://www.fluoridealert.org/epa-sf.htm#2.1

Second, we highlighted the problems of EPA's decision - in the absence of any new evidence - to increase the allowable safe dosage for children. As it now stands, EPA has established a new allowable dosage for infants (0.571 mg/kg/day) which is 5 times higher than the allowable dosage for adults (0.114 mg/kg/day). Prior to this Final Ruling, both DOW and EPA (as in previous pesticide rulings involving fluoride e.g. cryolite) have used the adult dosage across all age ranges. Our discussion of EPA's alteration, can be seen at http://www.fluoridealert.org/epa-sf.htm#3

Third, we highlighted the problems in EPA's analysis of current fluoride exposure among children. We found, for instance, that EPA had made a major mistake in its assessment of fluoride ingestion from toothpaste, and that it had greatly underestimated the exposure from this source. We also found that EPA's total dose estimates for children living in 2 ppm areas were lower than recent empirical data of the doses children are receiving in 1 ppm areas (Levy 2003). Indeed, we found that even with EPA's new, weakened safety standard for children, some children in 1 ppm areas are still exceeding it. Our discussion on this issue, can be seen at http://www.fluoridealert.org/epa-sf.htm#5

Fourth, we presented EPA with English translations of two studies (one Chinese, one Russian) which were not accounted for in EPA's analysis. There are, of course, many other foreign-language studies which EPA did not consider, but these were the only 2 studies for which we were able to access English translations. In the Chinese study (Shi 1995), a relationship was found between fetal bone damage and fluoride intake of the mother. In the Russian study (Bachinskii 1985), a relationship was found between fluoride intake from water at 2.3 ppm ( i.e. at F levels below the MCL) and thyroid impairment. The two translations are available at
http://www.fluoridealert.org/epa-sf/appendix-c.pdf and
http://www.fluoridealert.org/epa-sf/appendix-e.pdf

Fifth, in appendix D of our appeal (http://www.fluoridealert.org/epa-sf/appendix-d.pdf) we rebut EPA's attempt to dismiss all the studies which indicate that fluoride has impacts other than the limited single end point that they considered for their MCLG/MCL (crippling skeletal fluorosis). In addition to our own comments pointing out mistakes and cavalier dismissals we contacted some of the authors of studies which EPA had criticized and presented these authors' responses to EPA. This included a detailed response from Dr. Phyllis Mullenix responding to EPA's criticisms of her methodology, and a very interesting response from Dr. Stan Freni discussing his findings of reduced fertility rates in high fluoride areas (> 3 ppm) of the US.

According to Dr. Freni, his 1994 paper ("Exposure to high fluoride concentrations in drinking water is associated with decreased birth rates") was his "minority report" to the 1991 Public Health Service (PHS) review. Freni (then a toxicologist at the FDA) called the 1994 paper a "minority report" because he was a member of the subcommittee which wrote the PHS review. In working on the PHS review ("Fluoride: Benefits & Risks") Freni reviewed the literature on fluoride and reproductive toxicity in animals. Based on his review of the literature, Freni wrote up an analysis to be included in the PHS report. However, the PHS decided to leave Freni's review out of their final draft (and substituted it with a 'watered-down' version) because they thought Freni's literature review might "alarm the public." Here's an excerpt of Freni's email to us:

"Given my background I focused on the Risks, leaving the Benefits to the others. The results of my literature study were unexpected: all animal species studied revealed reproductive damage. There was no human study. The subcommittee's report had to be unanimous. I was asked to tone down my results to not alarm the public. My study was not criticized. After all, it was based simply on a review of peer-reviewed published papers. I refused to water down my report, and the committee decided to do it for me. The result is pp. 66-68 of the Febr. 1991 DHHS/CCEHRP report BENEFITS & RISKS."

In our submission, we juxtaposed Freni's review of the studies on fluoride/reproductive toxicity (which Freni eventually published in his 1994 paper) with the watered-down review contained in the 1991 Public Health Service Report. See: http://www.fluoridealert.org/epa-sf/appendix-f.pdf

It should be noted, however, that Freni's review was published before 2 other scientists at the FDA (Sprando & Collins) initiated their own series of experiments on the issue. In our submission to the EPA, we discuss some of the limitations with Sprando & Collins' frequently-cited findings. In contrast to repeated results of many other research teams, Sprando & Collins have been unable to detect reproductive problems in their fluoride-treated animals. In our submission, we argue that the findings of Sprando & Collins were insufficient to dismiss the findings of these other research teams (see appendix D at http://www.fluoridealert.org/epa-sf/appendix-d.pdf.)

Finally, we would like to seek clarification on three points of procedure for the NRC review.

1) Noting that the panel has heard extensive commentary from researchers on teeth and bone is it the panel's intention to seek input from researchers on other critical end points such as the central nervous system, the pineal gland and male reproductive effects?

2) In the event that there is a major split in findings of this panel is there a mechanism in place for a minority report? If not, how will major disagreements be resolved?

3) How are reviewers going to be selected for the final review of the panel's report? What efforts are going to be taken to ensure that reviewers are not taken from just one end of the spectrum of views on the fluoridation controversy? Will the public be invited to submit recommendations for consideration before the final reviewers are selected?

Sincerely,

Dr. Paul Connett,
Director of FAN
and
Professor of Chemistry,
St. Lawrence University,
Canton NY 13617
Tel: 315-379-9200 (home)
Tel: 315-229-5853 (office)
Email: pconnett@stlawu.edu

Response from Susan Martel, NRC:

From: "Martel, Susan" <SMartel@nas.edu>
Date: Wed, 7 Apr 2004 10:04:36 -0400
To: "Paul Connett" <pconnett@stlawu.edu>
Subject: RE: Toxicologic Risk of Fluoride in Drinking Water; BEST-K-02-05-A

Dr. Connett:

As requested, I forwarded your email to the Subcommittee on Fluoride in Drinking Water.

Regarding your questions about the three points of procedure:

1. The subcommittee is evaluating effects on systems other than the teeth and bones, including effects on the nervous, reproductive, and endocrine systems. However, at this time, there are no plans to hold any more public data gathering sessions. The subcommittee is devoting the remainder of its meetings to evaluating the literature and developing its report.

2. We will make every effort to achieve a consensus report. In the event this is not possible, we do have a mechanism whereby a dissenting statement may be written by the disagreeing member(s) and included as part of the subcommittee's report.

3. Reviewers are selected similarly to committee members. Careful consideration will be given to having reviewers with a broad range of perspectives. We do not formally invite the public to nominate reviewers, but if names are submitted to us we will consider them in the pool of candidates.

Regards,
Susan Martel