Comment submitted by B. Sachau

public comment on federal register of 8/23/06 vol 71 #162 pg 49448 docket 2006-0505 frl 8073-2 i think the only allowed residue should be .0000001. It is my opinion that i am skeptical about Dow. I think what they submit needs to be investigated further. i find this product too hazardous to human health to be allowed to be used. i recommend not allowing this product to be sold or manufactured in the u.s. i see no reason to poison mother earth. rachel carson told us the danger of this long long ago. the policy since then seems to have capitulated to profiteers and their wares. Reproductive Effects Doses of 200 mg/kg/day of amitraz for ten weeks decreased fertility in male and female rats. Female mice treated orally for 5 days with 50 mg/kg/day of amitraz and then mated showed a slight increase in loss of fetuses and a decrease in the number of living offspring. When male mice were given 50 mg/kg/day of amitraz orally for 5 days and then mated, the resulting embryos were significantly less likely to grow in the mother's uterus. Female mice who received 400 mg/kg/day of amitraz in their diet for up to 33 weeks, showed a significant increase in the time they were sexually receptive (8). The highest dose of amitraz which has no observable effect on the death of unborn rats (fetotoxic NOEL) is 3 mg/kg/day. The highest dose of amitraz that does not cause an observable effect in the death of rat embryos (Embryotoxic NOEL) is 5 mg/kg/day (9). Rats who received 12 mg/kg/day of amitraz from day one of pregnancy until the young were weaned at 21 days old had a reduced number of young born and alive at day four (8). Rabbits who received 25 mg/kg/day of amitraz from days 6 to 18 of pregnancy had fewer and smaller litters (1). Although there have been reproductive effects observed in laboratory animals at some dose levels, likely human exposures are very much less than those which produced effects. These effects are unlikely in humans under normal circumstances. Teratogenic Effects In one study, rats treated with 12 mg/kg/day of amitraz from days 8 to 20 of pregnancy, the offspring were heavier but had less bone development than the offspring of untreated rats (8). However, an EPA study indicates that the highest dose at which amitraz has no observable effect on test rats' offspring (teratogenic NOEL) is 12 mg/kg/day (9). The teratogenic NOEL of rabbits is 25 mg/kg/day (1). These studies indicate that high doses of amitraz exposure during pregnancy produced adverse effects in laboratory animals. Likely human exposures are very much less than those which produced effects, and these effects are unlikely in humans under normal circumstances. Mutagenic Effects A variety of tests indicate that amitraz is not mutagenic and does not cause damage to DNA (8). Carcinogenic Effects Long term feeding studies show that amitraz is not carcinogenic in rats. However, it can cause tumors in female mice (8). Amitraz causes an increase in tumors of the lungs and lymph nodes in female mice, but not males, at 57 mg/kg/day over 20 months. A two-year study of female mice also showed an increase in tumors of the liver (hepatocellular tumors) at 57 mg/kg/day of amitraz (4, 5). Because amitraz causes cancer in female mice, but not male mice or male or female rats, it is unclassifiable as to human carcinogenicity (10). Organ Toxicity At high doses, amitraz can reduce the function of the hypothalamus, which helps regulate the metabolism by controlling hormone release in the body (4). A daily dose of 200 mg of amitraz per kilogram of body weight for ten weeks causes decreased growth and food consumption (8). Fate in Humans and Animals Available data suggest that amitraz, following absorption into the blood, is not readily absorbed into tissues, and is mostly excreted unchanged via the urine (2, 4, 8). ECOLOGICAL EFFECTS Effects on Birds Amitraz is slightly toxic to birds. The dietary LC50 (8 day) is 7,000 mg/kg for mallard ducks and 1,800 mg/kg for Japanese quail (2, 7). The oral LD50 for bobwhite quail is 788 mg/kg (3). Amitraz may affect reproduction in birds. The avian reproduction NOEL is less than 40 ppm (4). Effects on Aquatic Organisms Amitraz is moderately toxic to fish (3, 4, 5). The LC50 (96-hour exposure) is 1.3 mg/l for bluegill sunfish and 3.2-4.2 mg/l for harlequin fish. For a 48-hour exposure of rainbow trout, a cold water species, the LC50 is 2.7-4.0 mg/l (2). Daphnia, a fresh water invertebrate, exhibited toxic b sachau 15 elm st florham park nj 07932