Fluoride Action Network

Sulfuryl fluoride: NY approves pesticide despite unresolved health risks

Source: Press Release: Fluoride Action Network | January 9th, 2006
Industry type: Pesticides

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
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®)

• December 16, 2005, submission to US EPA: Issues for an Evidentiary
Hearing Concerning Sulfuryl Fluoride Tolerances


• 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

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.