SCIENCE WATCH Newsletter: FAN's Objection to EPA's Ruling on Sulfuryl Fluoride

DIRECTORY: FAN > Health > Newsletter > Issue # 5

FAN SCIENCE-WATCH

March 31, 2004

Bulletin #5: FAN's Objection to EPA's Ruling on Sulfuryl Fluoride

by Michael Connett
Editor, FAN Science-Watch

On Monday, March 22nd, the Fluoride Action Network, in conjunction with Beyond Pesticides, submitted a formal objection to EPA's Final Rule on Sulfuryl Fluoride.

FAN is objecting to EPA's decision to approve Dow AgroSciences' request to use sulfuryl fluoride as a replacement fumigant for methyl bromide (which Dow also produced). In approving Dow's request to use sulfuryl fluoride, EPA has issued the highest level of fluoride pesticide residues "in or on food" in US history.

FAN's full objection to EPA's ruling is available online at http://www.fluoridealert.org/epa-sf.htm and a press release discussing our objection is available at http://www.fluoridealert.org/press/epa-sf.htm .

In this bulletin, I'd like to draw attention to some of the material we presented to the EPA in our objection.

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 dose for children. As it now stands, EPA has established an 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). To see our discussion of EPA's alteration, see 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. To see our discussion on this issue, see http://www.fluoridealert.org/epa-sf.htm#5

Fourth, we presented the 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 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, we contacted 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 on fluoride & reduced fertility was his "minority report" to the 1991 Public Health Service (PHS) review. Freni called the 1994 paper a "minority report" because Freni (who was then a toxicologist at the FDA) was a member of the committee which wrote the PHS review. In working on the PHS review ("Fluoride: Benefits & Risks"), Freni reviewed the literature on fluoride and reproductive toxicity. 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, which have long intrigued us. For, in contrast to repeated results of multiple other research teams, Sprando & Collins have been unable to detect reproductive problems in their fluoride-treated animals. In our submission, we argued that the findings of Sprando & Collins were insufficient to dismiss other findings of reproductive harm from multiple other research teams using other species of animals.

Finally, we drew attention to the failure of EPA's pesticide division to adhere to its own statutes and guidelines in developing the reference dose for fluoride. See: http://www.fluoridealert.org/epa-sf/appendix-k.pdf

Based on the above material, and additional material contained in our report, I believe we have made a strong case which the EPA will have a difficult time addressing - if of course they actually address what we have written.

I believe the EPA will have a particularly difficult time explaining:

* the empirically demonstrable errors in their analysis of current fluoride exposures;
* the justification for increasing the safe dose for children; and
* the justification of the Pesticide division establishing a safe reference dose based on a 20-year old drinking water standard (the 1985 MCL) that was only designed to protect against the extreme health effect of crippling skeletal fluorosis.

Of course, if history is any precedent there is reason for concern. When FAN pointed out to the EPA, in our earlier submissions, that children were already receiving more fluoride than EPA's safety standard allowed, the EPA responded - not by rejecting Dow's request to add more fluoride to our diet - but by weakening their safety standard!

However, even with EPA's new, weakened safety standard for children in place, EPA still needs to account for the fact that the most recent empirical data from the US (Levy 2003) has found that some children in fluoridated areas are currently receiving doses which exceed EPA's new standard.
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* FAN's Objection to EPA (full report):
http://www.fluoridealert.org/epa-sf.htm

** Press release announcing our objection:
http://www.fluoridealert.org/press/epa-sf.htm

 

 

 

 

 

 

 


 

 

 

 
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