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