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Groups Challenge EPA's Approval of Dow's Sulfuryl Fluoride: EPA allows 5 times higher levels for infants than adults
(Beyond Pesticides, March 30, 2004)
On March 22, 2004, the Fluoride Action Network (FAN) formally challenged US EPA's approval of Sulfuryl fluoride for use as a fumigant on a wide variety of foods.

EPA identified fluoride as the major toxicological endpoint of concern for exposure to Sulfuryl fluoride. In its Risk Assessment, which served as the basis for approval, EPA made an unprecedented decision to allow an acceptable dosage for infants (0.571 mg/kg bodyweight/day) which is five times higher than for adults (0.114 mg/kg/day).

The Washington, DC-based Beyond Pesticides joined FAN in submitting Written Objections and a Request for a Hearing, the process necessary to formally challenge EPA's decision.

This is the first time that Sulfuryl fluoride, produced by Dow AgroSciences, has been approved for food use. In its approval, EPA set the highest levels of fluoride residues "in or on food" in US history. As a fumigant it will be used on over 40 foods that include nuts, dried fruit, rice, wheat, barley, etc. Fumigants are used to kill the bugs that infest and destroy stored foods.

Sulfuryl fluoride is Dow's alternative to Methyl bromide, the ozone-destroying food fumigant that has a phase-out deadline of January 1, 2005, for developed countries.

FAN says there are alternatives available to Methyl bromide and Sulfuryl fluoride (both made by Dow) which would allow the US phase-out date to be met. And because alternatives are available, it is unnecessary to allow anyone, particularly the workers who will spray it, to be put at such risk.

EPA alters safety standard

According to Paul Connett PhD, Executive Director of FAN, and Professor of Chemistry at St Lawrence University in Canton NY, "EPA's data showed that some children were already receiving more fluoride than EPA's existing safety standard allowed. Such a situation should have been grounds for rejecting Dow's request to add an additional source of exposure to the diet."

However, instead of denying Dow's request, the EPA has opted to increase the tolerable dose for children.

Since children are already receiving excess fluoride from sources such as fluoridated water, toothpaste, and processed foods, Connett states that "EPA was basically faced with one of two choices: reject Dow's request or loosen the safety standard. The EPA chose the latter option."

"The science does not support EPA's decision to again support corporate greed instead of children's health," said Jay Feldman, executive director of Beyond Pesticides, a Washington-DC based national clearinghouse and advocacy organization. He continued, "It is time for the Bush Administration to stop using EPA to support pollution and poisons for political benefit."

"Unprecedented": EPA sets higher safe dose for infants than adults

EPA's move has left scientists familiar with risk assessment shaking their heads. In loosening the safety standard for children, EPA has created a situation where the acceptable dose for infants is five times higher than the acceptable dose for adults.

According to Connett, "We feel this is an unjustified and unprecedented decision by EPA, which runs counter to their mandate under the Food Quality Protection Act (FQPA) to set standards that are more protective of children, not less."

According to Chris Neurath, Research Associate with FAN: "If EPA's pesticide division had followed their statutory mandate they should have set a standard for children ten times more protective than for adults. Instead they have brazenly manipulated normal protocol and assigned a sensitivity for infants that is 5 times less protective! For infants to be deemed less sensitive than adults is unprecedented."

"There is every reason to believe that children are more sensitive to fluoride than adults," notes Connett. "EPA has cited no new data to justify its decision. We find this to be completely unacceptable."

Several senior scientists at EPA concur.

Speaking on condition of anonymity, senior scientists at EPA - familiar with pesticide risk assessment - explained to FAN that they "have not seen any case where an acceptable dosage for children is higher than for adults."

"EPA's action is irresponsible," they declared.

Profits for Dow, Risks for the Public

"We are deeply concerned," says Connett. "Based on the near epidemic rate of dental fluorosis in our children, it is clear that fluoride exposures need to be reduced, not increased."

Dental fluorosis, a mineralization disorder of teeth, is caused by excess ingestion of fluoride during a child's teeth-forming years. The condition is now seen in up to 50% of children in fluoridated areas, and in some children requires expensive cosmetic treatment.

But dental fluorosis is not FAN's only concern.

"The fortunate thing about dental fluorosis is that we can see it. We can see the white spots on a child's tooth and say 'yes, fluoride has caused cellular damage in that tooth.' But what about the internal organs - the ones we can't see?" asks Connett.

Recent reseach indicates that fluoride accumulates in the pineal gland, which is located between the two hemispheres of the brain. EPA knows that the pineal, an endocrine gland, contains hydroxyapatite (the same as bone) and that fluoride has been found to accumulate to even greater levels in the pineal than in the bone. The pineal gland produces the hormones melatonin and seratonin.

According to Connett, "Animal studies indicate that fluoride lowers the production of melatonin. One of the risks we may be taking by exposing our whole population to fluoride is interfering with delicate regulatory timing processes, from the onset of puberty to the aging process. However, EPA has chosen to ignore this concern."

Risk to Workers

Workers are at risk not only from the acute toxicity of Sulfuryl fluoride but also the potential for brain, lung, kidney, and bone effects.

Results reported from animal studies (rats, mice, dogs, rabbits) exposed to Sulfuryl fluoride all share these effects: holes in the brain, necrosis of the brain, and effects on the white matter of the brain (particularly the female species). These results, which come from tests performed by Dow scientists, are not without their limitations. Researchers did not test male rats in acute neurotoxicity tests. In subchronic neurotoxicity tests, the examination of nervous system tissues were only performed on the highest dosed animals, while a developmental neurotoxicity study has yet to be performed.

Over the past 4 years, the Fluoride Action Network has been working to raise awareness about recent research indicating the potential for human harm from current fluoride exposures.

According to FAN, a growing body of research suggests that fluoride may be associated with several serious health problems, including arthritis, hip fractures, bone cancer, kidney damage, infertility, and brain disorders.

"There is a profound need for precaution on the fluoride issue, and yet a profound absence of it exists in Washington," adds Connett.

TAKE ACTION: Read EPA's Final Rule along with the March 2004 Submission to EPA from FAN & Beyond Pesticides. Speak out by contacting Mr. Michael Leavitt, EPA Administrator by email, phone: 202-564-4711, or fax: 202-501-1470.