Comment submitted by b sachau

public comment on federal register of 9/13/06 vol 71 #177 docket 2006 07300001 esfenvalerate i oppose any sale, manufacture or use of this product. to me, it is far too dangerous to allow to poison mother earth. in addition, no tests with the thousands of other chemicals that are allowed by this agency have been done. some chemicals when they combine are 2000 times stronger - we cannot allow that to happen with this untested chemical. Toxicological Effects: Acute toxicity: Esfenvalerate is a moderately toxic compound via the oral route. The reported oral LD50 of esfenvalerate is 458 mg/kg in rats. It is slightly toxic via the dermal route, with a reported dermal LD50 of 2500 mg/kg in rabbits. It is practically non-toxic via inhalation, with a reported inhalation LC50 of greater than 2.93 mg/L in rats [2,12]. Because esfenvalerate is a relatively new compound it has little usage history. The bulk of evidence related to acute poisonings in humans due to esfenvalerate comes from incidents in India. Nearly 600 individual cases of poisoning were reported between 1982 and 1988. These cases were due to improper handling of the pesticide. Acute toxic effects were observed in workers and among the general public. Symptoms of acute poisoning included dizziness, burning and itching (which was worsened by sweating and washing). Severe cases of direct contact caused blurred vision, tightness in the chest, and convulsions (2). The changes appear to be reversible. In rats, high acute exposure to esfenvalerate produced muscle incoordination, tremors, convulsions, nerve damage, and weight loss. The compound may produce nausea, vomiting, headache, temporary nervous system effects such as weakness, tremors, and incoordination at acute exposure levels in humans. Esfenvalerate is a strong eye irritant, producing tearing or blurring of vision. Chronic toxicity: Rats fed fenvalerate at concentrations of approximately 12.5 mg/kg/day for two years had no compound-related changes in the blood or urine [12]. In other studies significant reduction in body weight was the main adverse effect seen in both rats and mice of both sexes. Reproductive effects: In a three-generation rat study, low doses (up to 12.5 mg/kg/day) of fenvalerate produced no toxicity in the fetus. Some maternal toxicity was noted in the second generation at the higher dose. When pregnant mice and rabbits were fed low dietary levels of fenvalerate (2.5 mg/kg/day) on days 6 to 15 of gestation, there was maternal toxicity in both species. It seems that during pregnancy, the females are more sensitive to fenvalerate than they would otherwise be, even though the toxicity is not reflected in any effect on the fetus [5]. There are no specific data available for esfenvalerate, but it is not expected to cause reproductive effects at low doses. Teratogenic effects: Esfenvalerate did not produce any birth defects in offspring at low dietary doses [2]. It appears the the pesticide would not pose a teratogenic threat to humans at expected exposure levels. Mutagenic effects: Esfenvalerate shows no mutagenic effects. Numerous tests in hamsters, mice and rats show no signs of mutagenic activity associated with this compound [2]. It is likely that it poses no mutagenic risk to humans. Carcinogenic effects: A rat study of fenvalerate conducted over a wide range of doses of up to 75 mg/kg, for two years, resulted in no evidence of cancer. Mice fed diets containing small amounts of fenvalerate for two years showed no adverse effects [2]. It appears that fenvalerate does not cause cancer. Organ toxicity: Studies to date have not shown any dose-related effects on internal organs of test animals or in human populations [2]. Fate in humans and animals: Cows treated with 0.1 or 0.5 g fenvalerate on their skin had 0.03 to 0.06% of the applied chemical in the milk. When the cows received fenvalerate orally at very low levels, about 0.50% of the dose appeared in the milk. Fenvalerate does not appear to be metabolized by bovine rumen, but it is degraded further down the digestive tract [32]. This happens rapidly with less than 0.02% of the parent compound found in the urine and 20% of the major metabolite present. Higher concentrations of the parent compound are present in the feces. In the rat, fenvalerate is rapidly broken down and almost completely eliminated within several days. One study indicated mammals eliminated 96% in the feces in 6 to 14 days [32]. While the data presented here are for fenvalerate, esfenvalerate behaves in the same manner [33]. Ecological Effects: Effects on birds: Esfenvalerate is slightly toxic to birds. Oral LD50 values for the compound are 1312 mg/kg in bobwhite quail and greater than 2250 mg/kg in mallard ducks [12]. Effects on aquatic organisms: Based on laboratory studies, fish are very sensitive to esfenvalerate. It has a 96-hour LC50 of 0.0003 mg/L in bluegill, 0.0003 mg/L in rainbow trout, 0.001 mg/L in carp, and 0.0002 mg/L in killfish [5]. The LC50 in Daphnia magna, an aquatic invertebrate, is 0.001 mg/L. The pesticide is very highly toxic to these species. Water turbidity, such as would be found in the field, tends to reduce the toxicity of this compound [5]. Bioaccumulation factors in rainbow trout are about 400 times the background (ambient water concentration of the pesticide) levels [5]. Effects on other organisms: Esenvalerate is highly toxic to bees. The compound tends to repel bees for a day or two after application, causing bee visitations to drop during that time [5]. Since most intoxicated bees die in the field before they can return to contaminate the hive, the brood is not exposed except by direct spray. Dried spray residues are not expected to pose a significant threat to bees [5]. Environmental Fate: Breakdown in soil and groundwater: Under field conditions, esfenvalerate is moderately persistent with a half-life ranging from about 15 days to three months depending on soil type [25]. In a soil laboratory study, 17% of the applied chemical was lost in 90 days. Esfenvalerate and its breakdown products are relatively immobile in soil and thus pose little risk to groundwater [11]. The compounds ability to bind to soil increases with increasing organic matter. It is very insoluble in water. Fenvalerate has not been found in over 100 tested groundwater supplies [34]. Breakdown in water: Esfenvalerate will break down in water to one-half of the original amount (half-life) in about twenty-one days due to sunlight [11]. Breakdown in vegetation: The parent compound is the residue most often found on foliage. In a series of trials in Canada where 16 varieties of fruits and vegetables were grown under typical outdoor conditions, no degradation products or metabolites were found (tests were sensitive to 0.05 mg/kg). Sampling was from 1 to 112 days after application. The half-life of esfenvalerate on plant surfaces is 2 to 4 weeks [31]. b. sachau 15 elm st florham park nj 07932