FOR IMMEDIATE RELEASE
Contact:
Ellen Connett
Fluoride Action Network Pesticide Project
315-379-9200 or pesticides@fluoridealert.org
January 9, 2006
New York State approves pesticide
despite unresolved health risks
Fluoride Action Network (FAN) urges the NYS Bureau of Pesticides
to rescind their recent approval of a new food fumigant pesticide,
sulfuryl fluoride, because serious health risks, raised by environmental
groups, remain unanswered by the US Environmental Protection Agency
(EPA).
In a November 28, 2005 letter to Dow AgroSciences, Maureen Serafini,
Director, NYS Bureau of Pesticides, approved sulfuryl fluoride
(ProFume®) fumigant on all processed foods and a large number
of raw food commodities in New York. These are the foods most
Americans eat.
In response, FAN’s Pesticide Project Director, Ellen Connett,
requested Director Serafini to revoke this approval.
On January 4, 2006, Connett sent a letter to Director Serafini
to inform her that three advocacy groups have raised serious concerns
about the inherent dangers of sulfuryl fluoride’s use as
a food fumigant. These issues have been presented to the EPA on
three separate occasions, beginning in 2002, and remain unresolved.
The three groups — Fluoride Action Network, the Environmental
Working Group and Beyond Pesticides — are seeking a resolution
of these issues with EPA in a process known as an evidentiary
hearing.
According to Connett, “An evidentiary hearing is the only
legal recourse available to the public to challenge EPA’s
wrongful approval of a pesticide. We fully expect that EPA will
grant this hearing.”
At EPA’s request, the three groups clarified their issues
in a December 2005 submission in preparation for the hearing.
Forty eight (48) issues were identified in this submission, which
was also sent to Director Serafini on 1/04/06.
“We expect Director Serafini to understand the serious
nature of the issues raised and the procedural process the three
advocacy groups are involved in. If she does, she will revoke
her approval of sulfuryl fluoride as a food fumigant until these
issues are resolved,” said Connett.
Because sulfuryl fluoride breaks down to fluoride in the human
body, fluoride is the endpoint of toxicological concern. In their
approval, EPA approved the highest levels of fluoride residues
in food in US history. Fluoride is persistent and bio-accumulates
in the human body.
Inhalation tests with all animal species exposed to sulfuryl
fluoride revealed severe harm to the brain. Of particular concern
was the finding of holes (vacuolation) in the white matter of
the brain, and an abnormal softening (malacia) and cell death
(necrosis) of brain tissue.
EPA’s first-time approval of sulfuryl fluoride as a food
fumigant was in January 2004. A condition attached to EPA’s
approval was that Dow had to perform an inhalation development
neurotoxicity (DNT) study with rats “to more clearly and
fully characterize the potential for neurotoxic effects in young
animals.”In fact, EPA also stated that a DNT study was necessary
in 2001, 2002 and 2005.
However, in the November 28 letter that Director Serafini wrote
to Dow, she noted that Dow told her Bureau that EPA waived this
study. It was Director Serafini’s letter that informed the
public of this development, not the US EPA.
“US EPA is obligated to publish Dow’s request for
a waiver of conditions, and the Agency’s response to it,
in the Federal Register. If Director Serafini is correct, then
EPA has not yet met its obligations to inform the public on this
critical issue,” said Connett.
“We are concerned to find that Director Serafini was willing
to accept the waiver of such a critical study. The three advocacy
groups are requesting more relevant DNT studies to characterize
the risks to cognitive function and the central nervous system,
and we hope that Director Serafini will join with us in making
sure these tests are performed,” said Connett. “The
pesticide community is well aware of a study published in 1998
that reported subclinical effects on the central nervous system
of workers using sulfuryl fluoride in non-food fumigation scenarios,”
said Connett.
Among the many issues that the three groups raised to EPA:
• Too many Americans, especially children, are currently
receiving too much fluoride – even by EPA’s own standards.
There is, therefore, no safe room for additional exposures.
• EPA set an allowable dosage of fluoride for infants that
is five times higher than for adults. This is unprecedented in
EPA’s history and disregards EPA’s mandate, under
the Food Quality Protection Act, to be more protective of a child’s
exposure to pesticides, not less.
• In approving Dow’s request, EPA ignored all research
published after 1985, choosing to rely instead on an antiquated
20-year-old standard which considers it safe for 40% of children
to develop moderate to severe dental fluorosis (a brown and black
staining of teeth, with pitting and erosion of enamel).
• New research indicating that low levels of fluoride can
damage the brain, the bones, the kidneys, and other tissues, is
currently being reviewed by the National Research Council (NRC).
The NRC is expected to release its report (The Toxicologic Risk
of Fluoride in Drinking Water) in 2006. EPA rushed approval to
give Dow what it wanted, without waiting for the NRC report.
For more information see:
• January 4, 2006,
letter from FAN’s Pesticide Project to the NY Bureau of
Pesticides requesting revocation of its approval of sulfuryl
fluoride
(ProFume®) as a food fumigant.
• November 28, 2005,
letter from Director of NY Bureau of Pesticides to
Dow approving use of sulfuryl fluoride (ProFume®).
http://www.fluorideaction.org/pesticides/profume.nys.registration.05.pdf
• December 16, 2005, submission to US EPA: Issues
for an Evidentiary
Hearing Concerning Sulfuryl Fluoride Tolerances
http://www.fluorideaction.org/pesticides/sf.submission.12-16-05.pdf
• Calvert GM et al (1998). Health effects associated with
sulfuryl
fluoride and methyl bromide exposure among structural fumigation
workers.
American Journal of Public Health 88(12): 1774-80. December. Abstract.
EPA's stated position
on condition for Developmental Neurotoxicity (DNT) Study:
September 5, 2001. Sulfuryl
Fluoride; Proposed Pesticide Temporary Tolerances. Proposed
Rule. Federal Register. Docket OPP-301166.
D. Conditions.
(5) A Developmental Toxicity Study.
February 7, 2002. Sulfuryl
Fluoride; Temporary Pesticide Tolerances. Final Rule. Federal
Register. Docket OPP-301166A.
The Agency has determined that this
study is not needed to evaluate potential risks associated with
the
proposed EUP. However, as a requirement for unconditional registration
of this product under the Federal Insecticide, Fungicide, and
Rodenticide Act, the Agency believes that the developmental
neurotoxicity study is warranted. The Agency is requiring this
study
because of the observation of treatment-related neurotoxic lesions
in
rats, mice, dogs and rabbits.
January 23, 2004. Sulfuryl
Fluoride; Pesticide Tolerance. Final Rule. Federal Register.
Docket OPP-2003-0373.
Based on the available evidence, the Agency is requiring an
inhalation developmental neurotoxicity (DNT) study in rats (Guideline
No. 870.6300) as a condition of registration in order to more
clearly
and fully characterize the potential for neurotoxic effects
in young
animals.
July 15, 2005. Sulfuryl
fluoride; Pesticide Tolerance. Final Rule. Federal Register.
Docket OPP-2005-0174.
Based on the available evidence, the Agency is requiring an
inhalation DNT study in rats (OPPTS Harmonized Guideline 870.6300)
as a
condition of registration in order to more clearly and fully
characterize the potential for neurotoxic effects in young animals.