Bayer CropScience. Pesticide Tolerance. FINAL RULE.

EPA determined that additional tolerances are needed in connection with the petitioned-for tolerances for wheat bran 0.80 ppm, grass forage at 7.0 ppm, and grass hay at 0.4 ppm, cattle kidney at 0.05 ppm, goat kidney
at 0.05 ppm, hog kidney at 0.05 ppm, horse kidney at 0.05 ppm, and sheep kidney at 0.05 ppm. EPA determined that tolerance levels are needed that differ from those proposed by the registrant for sweet corn forage at 0.45 ppm (0.4 ppm proposed) sweet corn stover at 0.30 ppm, (0.4 ppm proposed) wheat forage at 6.0 ppm (10.0 ppm proposed), wheat grain at 0.60 ppm (1.0 ppm proposed), wheat hay at 1.2 ppm (2.0 ppm proposed), and wheat straw at 0.35 ppm (0.5 ppm proposed). EPA determined that tolerances are not necessary for fat, meat, and meat
byproducts of cattle, goat, hog, horse, and sheep. Since permanent tolerances are being established for wheat
and kidney of cattle, goat, hog, horse, and sheep, emergency exemption tolerances for these commodities are being deleted.

Prenatal and postnatal sensitivity. According to EPA: There is no indication of additional susceptibility of young rats or rabbits following prenatal exposure to flufenacet in the developmental toxicity studies. There was an indication of qualitative susceptibility in the 2-generation reproduction study. Effects seen in the offspring in the reproductive toxicity studies (including increased pup death in early lactation and cannibalism) were more severe than those seen in the parental animals (increased liver weight and cytomegaly), although there was no difference in the NOAELs/LOAELS between parental animals and offspring in that study. Increased susceptibility (qualitative and quantitative) was seen in the developmental neurotoxicity study in rats. Decreased body weight was seen in pups at all dose levels, and additional effects, including decreased motor activity, delayed developmental landmarks, and decreases in morphometric measurements were seen at mid and high doses. Morphometric measurements were not made at the low dose. A slight decrease in body weight in mid and high dose dams during early lactation may have been due to palatability of test substance and was not considered adverse.

Conclusion. Several factors weighed in favor of the conclusion that no additional safety factor is needed to protect the safety of infants and children. First, there was no evidence of increased susceptibility in the developmental toxicity studies (rats and rabbits), and qualitative susceptibility seen in the rat reproduction study did not raise concerns because the pup death may be attributable to maternal cannibalism, and there was a clear NOAEL for the effect. Second, there are also no additional residual uncertainties with respect to exposure data:

Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations.

Cancellation of Pesticides for Non-payment of Year 2005 Registration Maintenance Fees.

Pesticide Emergency Exemptions.

Georgia Department of Agriculture
Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; October 27, 2003 to December 31, 2003.
North Carolina Department of Agriculture
Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; October 14, 2003 to December 31, 2003.
South Carolina Clemson University
Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; November 20, 2003 to January 31, 2004.
Virginia Department of Agriculture and Consumer Services
Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; October 16, 2003 to March 31, 2004.

Pesticide tolerances. FINAL RULE.

The following studies are required as a condition of registration.
1. A special comparative sensitivity study on thyroid hormone levels in neonatal and adult rats.
2. 28-day inhalation toxicity study in rats.

-- Developmental Neurotoxicity study in rats:
--- LOAEL = 1.7 mg/kg/day day. based on decreased body weight/body weight gain, and missing morphometric measurements in caudate/putamen, in pups.
-- 90-Day oral toxicity rodents - rat: LOAEL = 6.0(m) mg/kg/day based on decreased T4; 28.8 mg/kg/day (f) and on hematology and clinical chemistry findings
-- 90-day feeding - mouse: LOAEL (mg/kg/day)=64.2 (m), 91.3(f) based on systemic toxicity and histopathology of the liver, spleen, and thyroid.
-- 90-Day oral toxicity in nonrodents: LOAEL (mg/kg/day)= 7.20 (m); 6.90 (f) based on increases in LDH, globulin, and spleen pigment in females, decreased T4 and ALT values in both sexes, decreased albumin in males, and decreased serum glucose in females
-- 21/28-Day dermal toxicity: LOAEL(mg/kg/day)= 150(m);1,000(f) based on decreased T4 and FT4 levels in both sexes and histopathological findings in females
-- Prenatal developmental toxicity in rodents (rat): LOAEL = 125 mg/kg/day based on decreased fetal body weight, delayed ossificaition in skull, vertebrae, sternebrae, and appendages, and increased extra ribs.
-- Prenatal developmental toxicity in in nonrodents (rabbits): Developmental NOAEL = 25 mg/kg/day LOAEL = 125 mg/kg/day based on increased skeletal variations.
-- Reproduction and fertility effects - rat: LOAEL = 7.4 (m), (8.2 (f) mg/kg/day based on increased liver weight in F1 females and hepatocytomegaly in F1 males Reproductive NOAEL = 1.3 mg/kg/day LOAEL = 6.9 mg/kg/day based on increased pup death in early lactation (including cannibalism) for F1 liters and the same effects in F1 and F2 pups at 36 mg/kg/day.
-- Chronic toxicity dogs: NOAEL = 1.29(m), 1.14(f) mg/kg/day LOAEL = 27.75 (m), 26.82(f) mg/kg/day based on increased alkaline phosphatase, kidney, and liver weight in both sexes, increased cholesterol in males, decreased T3, T4, and ALT values in both sexes, and increased incidences of microscopic lesions in the brain, eye, kidney, spinal cord, sciatic nerve, and liver.
-- Chronic toxicity/ oncogenicity in rodents (rat): LOAEL = 19.3 (m), 24.4(f) mg/kg/day based on methemoglobinemia and multi-organ effects in blood, kidney, spleen, heart, brain, eye, liver and uterus. No evidence of carcinogenicity
-- Carcinogenicity mice: NOAEL = <7.4 ((m), 9.4 (f) mg/kg/day LOAEL = 7.4 (m), 38.4 (f) mg/kg/day based on increased incidence and severity of cataracts. No evidence of carcinogenicity

The Agency considered the lack of comparative data for thyroid hormone levels in adult and neonatal animals. Available data support the possibility of decreases in thyroid hormones in adult animals (decreases were observed in several studies conducted in rats, mice, rabbits, and dogs) at dose levels similar to those used in the submitted DNT study. Because of the above concern, a special comparative study on thyroid hormone levels in neonatal and adult rats is being requested by the Agency as a condition of registration.

Pesticide Emergency Excemptions:

-- Georgia. Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; October 10, 2002 to December 31, 2002.
-- Idaho. Specific: EPA authorized the use of flufenacet on wheat and triticale to control ryegrass; October 10, 2002 to June 30, 2003.
-- North Carolina. Specific: EPA authorized the use of flufenacet on wheat to control ryegrass; October 10, 2002 to December 31, 2002.
-- Oregon. Specific: EPA authorized the use of flufenacet on wheat and triticale to control ryegrass; October 10, 2002 to June 30, 2003.
-- South Carolina. Clemson University. Specific: EPA authorized the use of flufenacet on wheat to control annual ryegrass; November 20, 2002 to December 31, 2002.
-- Virginia. EPA authorized the use of flufenacet on wheat to control ryegrass; October 10, 2002 to December 31, 2002.
-- Washington. Specific: EPA authorized the use of flufenacet on wheat and triticale to control ryegrass; October 10, 2002 to June 30, 2003.

Extension of Tolerances for Emergency Exemptions. EPA has authorized under FIFRA section 18 the use of N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5- (trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide on wheat and triticale for control of ryegrass in Idaho, Oregon, and Washington. This regulation extends a time-limited tolerance for combined residues of the herbicide N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5- (trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and its metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in or on wheat grain at 1 ppm, wheat forage at 10 ppm, wheat hay at 2 ppm, wheat straw at 0.5 ppm, meat and fat of cattle, goats, horses, hogs, and sheep at 0.05 ppm, meat byproducts (other than kidney) of cattle, goats, horses, hogs, and sheep at 0.10 ppm and kidney of cattle, goats, horses, hogs, and sheep at 0.50 ppm for an additional 1-year, 11 months. These tolerances will expire and are revoked on June 30, 2005. Time-limited tolerances were originally published in the Federal Register of August 6, 1999 (64 FR 42839) (FRL-6091-9).

• Emergency Exemptions:
• Idaho: EPA authorized the use of flufenacet on wheat and triticale to control annual ryegrass; October 3, 2001 to June 30, 2002.
• Oregon- Specific: EPA authorized the use of flufenacet on wheat and triticale to control annual ryegrass; October 3, 2001 to June 30, 2002.
• South Carolina - Crisis: On November 16, 2001, for the use of flufenacet on wheat to control annual ryegrass. This program ended December 31, 2001.
• South Carolina- Specific: EPA authorized the use of flufenacet on wheat to control annual ryegrass; November 29, 2001 to December 31, 2001.
• Virginia - Specific: EPA authorized the use of flufenacet on wheat to control annual ryegrass; October 1, 2001 to December 31, 2001.
• Washington - Specific: EPA authorized the use of flufenacet on wheat and triticale to control annual ryegrass; October 3, 2001 to June 30, 2002.

BAYER - request: Time-Limited Pesticide Tolerances.- FINAL RULE. This regulation establishes a time-limited tolerance for indirect or inadvertent residues in or on certain raw agricultural commodities when present therein as a result of the application of flufenacet to field corn and soybeans as a herbicide.These tolerances expire April 30, 2003.

BAYER - Pesticide Tolerance Petition for residues and metabolites containing the 4-fluoro-N- methylethyl benzenamine moiety in or on the raw agricultural commodities of Crop Group 15 (cereal grains), Crop Group 16 (forage, stover and hay of cereal grains), Crop Group 17 (grass forage, and grass hay), alfalfa forage, alfalfa hay, alfalfa seed, clover forage, and clover hay at 0.1 ppm when present therein as a result of the application of flufenacet to field corn and soybeans as a herbicide.

• BAYER - Conditional approval of 3 new herbicide product registrations:
• FOE 5043 Technical Herbicide for use only in the manufacturing of herbicides. EPA Reg. No. 3125-486
• FOE 5043 DF Herbicide for control of certain grass and broadleaf weeds in corn and soybeans. EPA File Reg. No. 3125-487
• Axiom DF Herbicide for control of certain grass and broadleaf weeds in corn and soybeans. EPA Reg. No. 3125-488. The product Axiom DF also contains 13.6% of the active ingredient metribuzin 1-amino-6-(1,1-dimethylethyl)-3- (methylthio)-1,2,4-triazin-5(4H)-one.

BAYER - Correction to Time-Limited Pesticide Tolerance. - FINAL RULE.. For residues in or on: CORN, FIELD: forage (0.4 ppm); grain (0.05 ppm); stover (0.4 ppm); Soybean seed (0.1 ppm). This tolerance expires April 30, 2003.

BAYER - Time-Limited Pesticide Tolerance. - FINAL RULE. For residues in or on: CORN, FIELD: forage (0.05 ppm); grain (0.4 ppm), stover (0.4 ppm); Soybean seed (0.1 ppm).

BAYER - Pesticide Tolerance Petition; for residues of the herbicide FOE 5043 in or on the raw agricultural commodities, field corn grain at 0.05 ppm, field corn forage at 0.4 ppm, field corn stover (fodder) at 0.4 ppm, soybean seed at 0.1 ppm, milk at 0.01 ppm, meat at 0.05 ppm, and meat byproducts at 0.05 ppm.

BAYER - Petition for Pesticide Tolerances for the herbicide FOE 5043 in or on the raw agricultural commodities field corn grain at 0.05 ppm, field corn forage at 0.4 ppm, field corn stover (fodder) at 0.4 ppm, soybeans at 0.1 ppm, milk at 0.01 ppm, meat at 0.05 ppm, and meat by products at 0.05 ppm.

• BAYER - Application to Register three herbicide products:
• FOE 5043, for use only in the manufacturing of herbicides. Active ingredient at 95 %. EPA File Symbol: 3125-UIA.
• FOE 5043 DF, for control of certain grass and broadleaf weeds in corn and soybeans. Active ingredient at 60 %. EPA File Symbol: 3125-UIT
• Axiom DF, for control of certain grass and broadleaf weeds in corn and soybeans. Active ingredients flufenacet and Metribuzin 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4- triazin-5(4H)-one at 54.4 and 13.6 % respectively. EPA File Symbol: 3125-UII.