Arysta LifeScience. Pesticide tolerance. FINAL RULE. This regulation establishes a tolerance for combined residues
of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on
-- wheat, forage at 0.30 ppm
-- wheat, grain at 0.01 ppm
-- wheat, hay at 0.10 ppm
-- wheat, straw at 0.05 ppm;
and combined residues of flucarbazone-sodium and its metabolites converted to 2-(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on
-- milk at 0.005 ppm
-- meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm
-- liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm.

Arysta LifeScience. Time-Limited Pesticide Tolerance. FINAL RULE. The time limited-tolerance previously issued September 29, 2000, will be extended for 13 months and will expire on November 30, 2006. A time-limited tolerance will be issued due to outstanding studies (independent laboratory validations of: Analytical Method for the Determination O-Desmethyl MKH 6562 (Metabolite of MKH 6562 in Soil by High Performance Liquid Chromatography Tandem Mass Spectrometry), Analytical Method for the Determination of MKH 6562 and Metabolites NODT (N,O-dimethyltriazolinone), Sulfonic Acid and Sulfonamide in Soil by High Performance Liquid Chromatography Tandem Mass Spectrometry, and Analytical Method for the Determination of MKH 6562 and Three Metabolites in Groundwater by High Performance Liquid Chromatography Tandem Mass Spectrometry) will be submitted to the Agency by the registrant in January 2006.

• A summary of the toxicological endpoints for flucarbazone-sodium used for human risk assessment is discussed in final rule published in the Federal Register of September 29, 2000 - see below.

• the estimated environmental concentrations (EECs) of flucarbazone-sodium for acute exposures are estimated to be 1.42 parts per billion (ppb) or surface water and 0.2 ppb for ground water. The EECs for chronic exposures are estimated to be 1.25 ppb for surface water and 0.2 ppb for ground water.

• A default Maximum Residue Limit (MRL) of 0.01 ppm has been established in Canada for residues of flucarbazone-sodium and its N-desmethyl metabolite on wheat grain. This value is consistent with the
tolerance being established in the United States on wheat grain.

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

Arvesta Corporation - Pesticide Petition: PP 5F6949. Petition to establish pesticide tolerance. The proposed tolerance expression is parent flucarbazone-sodium and N-desmethyl flucarbazone-sodium.

• An acute neurotoxicity screening study in rats established an overall NOAEL for males and females of 500 mg/kg based on transient neurobehavioral effects.
• Reproductive and developmental toxicity. Himalayan rabbits were administered flucarbazone-sodium at levels of 0, 100, 300, 500, or 1,000 mg/kg/bwt by oral gavage days 6 through 28 post coitum in a test for developmental toxicity. A maternal NOAEL of 100 mg/kg bwt/day was established based on clinical findings, body weight loss, decreased feed consumption, gastrointestinal changes, increased liver weights, and fatty liver changes at 300 mg/kg bwt/day. The gestation rate NOAEL of 100 mg/kg bwt/day was based on one abortion (assessed as secondary due to maternal toxicity) at 300 mg/kg bwt/day. The NOAEL for fetal parameters of 300 mg/kg bwt/day was based on decreased fetal weights and delayed ossification at 500 mg/kg bwt/day.

• Subchronic toxicity. A 28-day dermal rabbit study established a systemic NOAEL of >1,000 mg/kg bwt/day (the dermal limit dose) for males and females. The local dermal effects, skin thickening, seen at 1,000 mg/kg were regarded as a result of mechanical friction and of no toxicological relevance.

-- A 90-day rat feeding study defined a NOAEL at 250 ppm (17.6 mg/ kg bwt/day) for males and 1,000 ppm (101.7 mg/kg bwt/day) for females based on a decreased spleen weight in males at 1,000 ppm and on immunologic changes at 4,000 ppm in females.
-- A 90-day feeding study with male and female B6C3F1 mice established a NOAEL of 7,000 ppm (equivalent to >2,083, and 3,051 mg/kg bwt/day for males and females, respectively). The dose of 7,000 ppm was the HDT.
-- A 90-day dog feeding study at levels of 0, 1,000, 5,000, and 50,000 ppm established a NOAEL of 1,000 ppm (equivalent to 33.8 mg/kg bwt/day in males and 35.2 mg/kg bwt/day in females) based on decreased thyroxine levels and increased thyroxine-binding capacity, macroscopic and microscopic effects on the gastric mucosa and an eosinophilic hepatocellular cytoplasm occurring at 5,000 ppm and above. The liver enzyme induction at 1,000 ppm was assessed as a slight adaptive response in the detoxification process of flucarbazone-sodium but not as an adverse effect, due to the absence of clinical chemical changes that would indicate liver damage and due to the absence of any histopathologic liver changes at this dietary level.
-- A 28-day (6 hours/day; 5 days/week) subacute inhalation toxicity study was conducted with male and female Wistar rats exposed to mean actual concentrations of 5.2, 30.0, 180.1 and 513.3 mg/m3 air. A NOAEL of 5.2 mg/m3 air was established based on histopathological changes observed at 30 mg/m3 air and above.

• BAYER - Conditional Approval of Herbicide Products:
• Everest Technical, for formulation of herbicides for use on spring and winter wheat (EPA Reg No. 3125-533);
• Everest 70% Water Dispersible Granular In Water Soluble Packets, for post emergence control of wild oat and green foxtail in spring and winter wheat (EPA Reg. No. 3125-534);
• Everest 70% Water Dispersible Granular Herbicide, for post emergence control of wild oat and green foxtail in spring and winter wheat (EPA Reg. No. 3125-535).

BAYER - Time-Limited Pesticide Tolerances. - FINAL RULE. This regulation establishes time-limited tolerances for combined residues of and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2- (trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone- sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 1.5 ppm. The tolerances will expire and be revoked on November 1, 2005.

• BAYER - Registration applications for THREE pesticide products:
• Flucarbazone-Sodium Technical Herbicide. Active ingredient: Flucarbazone-sodium at 95.6%. For use only in the manufacturing of herbicides.
• Flucarbazone-Sodium 70% Water Dispersible Granular Herbicide. Active ingredient: Flucarbazone-sodium at 70%. For post emergence control of wild oat and green foxtail in all types of spring wheat.
• Flucarbazone-Sodium 70% Water Dispersible Granular In Water Soluble Packets. Active ingredient: Flucarbazone-sodium at 70%. For post emergence control of wild oat and green foxtail in all types of spring wheat.

BAYER - Pesticide Petition to establish tolerances for residues of flucarbazone sodium and its N-desmethyl degradate in or on the raw agricultural commodities:
• WHEAT:
forage at 0.30 ppm
hay at 0.10 ppm
straw at 0.05 ppm
grain at 0.01 ppm
• MILK at 0.005 ppm
• MEAT (cattle, goats, sheep, horses, hogs) at 0.01 ppm
• LIVER (cattle, goats, sheep, horses, hogs) at 0.60 ppm