Bayer CropScience. Pesticide Petition. PP 7F7200. Proposal for tolerances in or on food
commodities:

-- grain, cereal group 15 (except rice) at 4.0 ppm

This group includes 100 commodities.
barley • barley, bran • barley, cereal • barley, flour • barley, grain • barley, pearled barley • buckwheat • buckwheat, flour • buckwheat, fodder • buckwheat, forage • buckwheat, grain • cereal, cooked • cereal, flour • cereal, flour and related products • corn • corn, cereal • corn, field • corn, field, aspirated grain fractions • corn, field, dry milling • corn, field, flour • corn, field, grain • corn, field, grits • corn, field, meal • corn, field, milled byproducts • corn, field, refined oil • corn, field, soapstock • corn, field, starch • corn, field, wet milling • corn, pod, grain • corn, pop • corn, pop, grain • corn, sweet • corn, sweet, kernel plus cob with husks removed • grain, aspirated grain fractions • grain, cereal • grain, crops • grain, crops, except corn, fresh and rice, grain • grain, crops, except wheat • grain, forage and stover • macaroni products • millet • millet, flour • millet, grain • millet, pearl • millet, pearl, grain • millet, proso • millet, proso, flour • millet, proso, grain • noodle products • oat • oat and barley animal feed mixture, 97% oats, 3% barley • oat, bran • oat, cereal • oat, flour • oat, grain • oat, groats/rolled oats • rice • rice, bran • rice, cereal • rice, cracked • rice, cracked, malted beverage • rice, flour • rice, grain • rice, hulls • rice, polished rice • rice, wild • rice, wild, grain • rye • rye, bran • rye, cereal • rye, flour • rye, grain • sorghum, grain • sorghum, grain, aspirated grain fractions • sorghum, grain, brain • sorghum, grain, flour • sorghum, grain, grain • sorghum, milled fractions, except flour • teosinte • teosinte, grain • triticale • triticale, grain • wheat • wheat, aspirated grain fractions • wheat, bran • wheat, cereal • wheat, flour • wheat, germ • wheat, gluten, postharvest in australia • wheat, grain • wheat, middlings • wheat, milled byproducts • wheat, shorts • wheat, vavilovi • wheat, vavilovi, grain • wheat, wild einkorn • wheat, wild einkorn, grain • wheat, wild emmer • wheat, wild emmer, grain

-- grain, cereal, (forage, fodder, and straw), group 16 (except rice) at 7.0 ppm.

This group includes 50 commodities.
barley, hay • barley, straw • corn, field • corn, field, aspirated grain fractions • corn, field, forage • corn, field, hay • corn, field, stover • corn, pod • corn, pod, stover • corn, pop • corn, pop, stover • corn, sweet, cannery waste • corn, sweet, forage • corn, sweet, stover • grain, cereal, forage, fodder and straw, group, for forage, except sweet corn, forage • grain. cereal, group • grass, hay • millet, forage • millet, hay • millet, pearl, forage • millet, pearl, hay • millet, pearl, straw • millet, proso, forage • millet, proso, hay • millet, proso, straw • millet, straw • oat • oat, forage • oat, hay • oat, straw • rice, forage • rice, hulls • rice, straw • rice, wild • ricegrass, indian • rye, forage • rye, straw • sorghum, forage • sorghum, forage, forage • sorghum, forage, hay • sorghum, forage, silage • sorghum, grain • sorghum, grain, forage • sorghum, grain, stover • wheat, forage • wheat, hay • wheat, straw • wheat, vavilovi, straw • wheat, wild einkorn, straw • wheat, wild emmer, straw

Bayer CropScience. Pesticide Petition. PP 6F7160. Proposal for tolerances in or on food commodities

-- beet, sugar, roots at 0.09 ppm
-- beet, sugar, dried pulp at 11.0 ppm

IR-4. Pesticide petition: 6E7058.
New tolerance proposal, in or on raw agricultural commodities
-- grass, forage at 15 ppm
-- grass, hay at 40 ppm

BAYER & IR-4. Pesticide tolerances. FINAL RULE.

-- toxicity studies reviewed are discussed in the Federal Register of September 27, 2002

-- EPA determined that the FQPA Safety Factor to protect infants and children should be removed.

-- Cyfluthrin is a type II pyrethroid (i.e., it has a cyano group at the carbon position of the alcohol moiety and it is more effective when the ambient temperature is raised). Beta-cyfluthrin is an enriched isomer of cyfluthrin. Bridging data on beta-cyfluthrin were submitted so that the toxicity of beta-cyfluthrin could be compared with that of cyfluthrin and the databases could be combined to form one complete database for both chemicals. The scientific quality of the data is relatively high, and the toxicity profiles of both cyfluthrin and beta-cyfluthrin can be characterized for all effects, including potential developmental, reproductive and neurotoxic effects. A beta-cyfluthrin developmental neurotoxicity study has been submitted and a preliminary review indicates that effects are seen only at doses higher than those chosen for risk assessment purposes.

-- Cyfluthrin is a member of the pyrethroid class of pesticides. EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the pyrethroids. Although all pyrethroids alter nerve function by modifying the normal biochemistry and physiology of nerve membrane sodium channels, available data show that there are multiple types of sodium channels and it is currently unknown whether the pyrethroids as a class have similar effects on all channels or whether modifications of different types of sodium channels would
have a cumulative effect. Nor do we have a clear understanding of effects on key downstream neuronal function, e.g., nerve excitability, or how these key events interact to produce their compound specific patterns of neurotoxicity. Without such understanding, there is no basis to make a common mechanism of toxicity finding. There is ongoing research by the EPA's Office of Research and Development and pyrethroid registrants to evaluate the differential biochemical and physiological actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When available, the Agency will consider this research and make a determination of common mechanism as a basis for assessing cumulative risk. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

-- Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for cyfluthrin in drinking water.

Requests to Voluntarily Cancel Certain Pesticide Registrations.

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

Announcement: Longitudinal Study of Young Children's Exposures in their Homes to Selected Pesticides, Phthalates, Brominated Flame Retardants, and Perfluorinated Chemicals (A Children's Environmental Exposure Research Study--CHEERS).

Abstract: The U.S. EPA's Office of Research and Development's National Exposure Research Laboratory proposes to conduct a two-year longitudinal field measurement study of young children's (aged 0 to 3 years) potential exposures to current-use pesticides and selected phthalates, polybrominated diphenyl ethers, and perfluorinated compounds that may be found in residential environments. The study will be conducted in Duval County, Jacksonville, Florida over a two-year period from 2004 to 2006. Sixty young children will be recruited into this study in two cohorts: (1) infants recruited into the study soon after birth, and, (2) children recruited into the study at approximately 12 months of age.

Bayer and IR-4. Pesticide tolerance petition.

• Two subchronic inhalation studies were conducted with cyfluthrin.
In the first study, cyfluthrin was administered via inhalation for 5
days per week for 3 weeks. The resulting NOAEL was 1.4 mg/
m3, based on treatment-related behavioral effects, body
weight decreases and organ weight changes at 10.5 mg/m3. In
the second study cyfluthrin was administered via inhalation for 13-
weeks. The resulting NOAEL was 0.09 mg/m3, based treatment-
related behavioral effects in females and increased urinary protein in
males at 0.71 mg/m3.
• Subchronic toxicity. In a 28-day oral gavage study in rats,
cyfluthrin demonstrated a NOAEL of 20 mg/kg bwt/day, based on clinical signs of neurotoxicity, decreased body weight gain and changes in liver and adrenal weights at 80 and 40 mg/kg bwt/day, respectively. In a 90-day feeding study in rats, the resulting NOAEL was 9.5 mg/kg bwt/day, based on decreased body weight gain, gait abnormalities, skin lesions and mortality seen at 37.5 mg/kg bwt/day. A 6-month toxicity feeding study in dogs established a NOAEL of 5 mg/kg bwt/day. The LOAEL was 15 mg/kg bwt/day based on clinical signs of neurotoxicity and gastrointestinal disturbances.
• Reproductive and developmental toxicity. A developmental
toxicity study in rats indicated a maternal no observed adverse effect
level (NOAEL) of 3 milligrams/kilogram body weight day (mg/kg bwt/day) based on reduced body weight gain and food consumption at 10 mg/kg bwt/day. The developmental NOAEL was 10 mg/kg bwt/day, based on reduced fetal body weights and increased skeletal variations at the maternally toxic dose of 40 mg/kg bwt/day. An oral developmental toxicity study in rabbits with a maternal NOAEL of 20 mg/kg bwt/day and a maternal lowest observed adverse effect level (LOAEL) of 60 mg/kg bwt/day, based on decreased body weight gain and decreased food consumption during the dosing period. A fetal NOAEL of greater than 180 mg/kg bwt/day was also observed in this study. A two-generation reproduction study in rats indicated parental and offspring NOAELs of 3.0 mg/kg bwt/day, based on reductions in body weight and food consumption in the parents and course tremors and decreased mean litter weights in the offspring at 9.0 mg/kg bwt/day. The NOAELs were confirmed in a supplemental two-generation study.

EPA approved the use of Cyfluthrin for 9 Emergency Exemptions.

-- Idaho: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on wheat to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Idaho: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on barley to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Montana: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on wheat to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Montana: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on barley to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Oregon: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on wheat to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Oregon: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on barley to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- South Dakota: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on stored grains to control the lesser grain borer; July 24, 2002 to July 17, 2003.
-- Washington: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on wheat to control the lesser grain borer; August 1, 2002 to July 31, 2003.
-- Washington: EPA authorized the use of cyfluthrin and chlorpyrifos-methyl on barley to control the lesser grain borer; August 1, 2002 to July 31, 2003.

69 Pesticide Tolerances. FINAL RULE. For residues in or on: Alfalfa 5.0; Alfalfa, hay10.0; Barley, bran 5.0; Brassica, head and stem, subgroup 2.5; Carrot 0.20; Cattle, fat 10.0; Cattle, meat 0.40; Cattle, meat byproducts 0.40; Citrus, dried pulp 0.3; Citrus, oil 0.3; Corn, field, forage 3.0; Corn, field, milled byproducts 7.0; Corn, field, refined oil 30.0; Corn, field, stover 6.0; Corn, pop, stover 6.0; Corn, sweet, forage15.00; Corn, sweet, kernel plus cob with husks removed 0.05 Corn, sweet, stover 30.00; Cotton, hulls 2.0; Cotton, refined oil 2.0; Cotton, seed 1.0; Egg 0.01; Fruit, citrus, group 0.2; Goat, fat 10.0; Goat, meat 0.40; Goat, meat byproducts 0.40; Grain, aspirated fractions 600; Grain, cereal, group 4.0; Hog, fat 10.0; Hog, meat 0.40; Hog, meat byproducts 0.40; Hop, dried cones 20.0; Hop, fresh 4.0; Horse, fat 10.0; Horse, meat 0.40; Horse, meat byproducts 0.40; Lettuce, head 2.0; Lettuce, leaf 3.0; Milk 1.0; Milk, fat 30.0; Mustard greens 7.0; Oat, bran 5.0; Pea, dry 0.15; Pea, southern, succulent 0.25; Pepper 0.50; Potato 0.01; Poultry, fat 0.01; Poultry, meat 0.01; Poultry, meat byproducts 0.01; Radish, roots 1.0; Rice, bran 6.0; Rice, hulls 18.0; Rye, bran 5.0; Sheep, fat 10.0; Sheep, meat 0.40; Sheep, meat byproducts 0.40; Sorghum, grain, forage 2.0; Sorghum, grain, stover 5.0; Soybean, forage 8.0; Soybean, hay 4.0; Soybean, seed 0.03; Sugarcane, cane 0.05; Sugarcane, molasses 0.20; Sunflower, forage 5.0; Sunflower, seed 0.02; Tomato 0.20; Tomato, paste 0.5; Tomato, pomace 5.0; Wheat milled byproducts, except flour 5.0.

28-Day oral toxicity- LOAEL = 50 based on, gait abnormalities, salivation, nervousness, decrease in body weight, food consumption, changes in hematological, clinical chem. & urinalysis parameters, increases in selected organ wts., cytoplasmic swelling of glandular epithelium of submaxillary gland, minimal degrees of fiber degeneration in sciatic nerve (# not reported) which disappeared after recovery period.
90-Day inhalation toxicity study--rats: LOAEL = 0.00071 mg/L (0.16 mg/kg/day) based on decreased body weights and body weight gains in males and clinical signs in females
4-Week inhalation toxicity study--rats: LOAEL = 0.006 mg/L (1.6 mg/kg/day; males & females) based on decreases in body weight and body weight gain in males, hypothermia, reduction in leukocyte counts (F) and low serum protein.
Prenatal developmental toxicity via inhalation- rat: Maternal LOAEL = 0.00046 mg/L (0.125 mg/kg/ day) based on decreased body weight gain and relative food efficiency Developmental LOAEL = 0.00255 mg/L (0.692 mg/ kg/day) based on reduced fetal and placental weights and reduced ossification in phalanx, metacarpals, vertebrae
Prenatal developmental toxicity via inhalation-- rat: Combined maternal LOAEL= 0.0047 mg/L (1.277 mg/kg/day) based on reduced motility, dyspnea, piloerection, ungroomed coats, eye irritation Developmental LOAEL = 0.0011 mg/L (0.299 mg/ kg/day) based on increased incidence of runts and skeletal anomalies in sternum.
Reproduction and fertility effects study-- rat (dietary): Offspring LOAEL = 19 based on coarse tremors in pups during lactation and decreases in mean litter weight .
Pilot 1-generation reproduction study--rat: Parental systemic LOAEL = 59.6 based on hind leg splay, ataxia, reduction in body weight gain. Pup systemic LOAEL = 22.9 based on tremors during lactation and pup weight decreases.
Chronic toxicity--feeding Chronic toxicity--feeding study dog: LOAEL = 16.0 (males & females) based on gait Cyfluthrin abnormalities, vomiting, liquid feces, decreased body weights (males).
Neurotoxicity oral studies--hen: In the single-dose study, at 5,000 mg/kg, five of the ten hens died. Moderate fiber alterations (axon fragmentation, occasional swelling and eosinophilia of the axon fragments and vacuolation of the myelin sheaths)... a second set of symptoms developed in 4/30 hens. These symptoms resembled delayed type neurotoxicity. Nerve fiber degeneration was present in the majority of the hens. The myelin sheath was distended and the myelin sheath was described as being optically void or granularly disintegrated. The axons were described as swollen or fragmented and in some areas activated or proliferated Schwann's cells were noted. The nerves also contained macrophages in which cytoplasm contained granular material... In the 5-day study, 4/10 hens died. All hens showed initial toxic responses which eventually disappeared. Behavioral disorders accompanied by drowsiness and a cramped gait were observed in 3 of the 6 survivors. Mottled kidneys and brittle livers were noted at necropsy. Treatment-related fiber degeneration (distension or granular disintigration of the medullary sheath, swollen or fragmented axis cylinders and proliferated Schwann's cell in the sciatic nerve were reported. One hen had similar lesions in the spinal marrow.
Neurotoxicity dermal studies--hen: In the first study there were 2 deaths on the 3rd and 10th day. All other hens had symptoms (apathy and disturbed behavior) but recovered. Local irritation and weight loss were also noted. Two hens had minimal segment-like nerve fiber degeneration (sciatic nerve), but this type is often found in hens. In the second study, the hens were apathetic. These symptoms disappeared after the first week in all hens except 2, in which they persisted until the 38th and 51st day after the start of the treatment, respectively. Local irritation and body weight loss were also observed.
Metabolism and pharmacokinetics: ... At 48 hours, only the fat tissue (renal fat) contained levels of radioactivity that clearly exceeded the overall mean body level, being 6-11X higher. Levels of radioactivity in brain were quite low, being 15-20X lower than the overall mean body level...

BAYER - Notice to Cancel Products: Tempo 2 Insecticide.

IR-4 * - Pesticide Tolerance Petition; in or on southern pea at 0.23 ppm and dry peas (pigeon peas, chickpeas/garbanzo beans, lentils) at 0.05 ppm.

BAYER - Pesticide Petition Tolerance for residues in or on potatoes at 0.01 ppm. It also removes time limitations for tolerances for residues of cyfluthrin on sweet corn, field corn, and pop corn (including forage and fodder) set July 5, 1995- FINAL RULE.

BAYER - Petition to Establish Tolerances for residues in or on the raw agricultural commodity soybean, bean at 0.03 ppm; soybean, forage at 8.0 ppm; soybean, hay at 4.0 ppm; field corn, forage at 3.0 ppm; and field corn, fodder at 6.0 ppm.

BAYER - Pesticide Tolerance Petition for residues of cyfluthrin in or on the raw agricultural commodity potato at 0.01 ppm.

IR-4 * - Pesticide Tolerance Petition; for residues of the insecticide in or on the raw agricultural commodity dried hops at 20 ppm and to remove the established tolerance for fresh hops at 4.0 ppm.

BAYER - Pesticide Petition for Tolerances. FINAL RULE.This regulation establishes various tolerances for residues of cyfluthrin in or on the raw agricultural commodities: alfalfa; alfalfa, hay; aspirated grain fractions at 300 ppm; hops, dried at 20 ppm, carrots; cattle, fat; cattle, meat; cattle, meat by-products (mbyp); citrus, crop group; citrus dried pulp; citrus oil; cottonseed; cottonseed, hulls; cottonseed, oil; eggs; goats, fat; goats, meat; goats, mbyp; hogs, fat; hogs, meat; hogs, mbyp; horses, fat; horses, meat; horses, mbyp; milkfat at 15 ppm; peppers; poultry, fat; poultry, meat; poultry, mbyp; radishes; sheep, fat; sheep, meat; sheep, mbyp; sorghum, fodder; sorghum, forage; sorghum, grain; sugarcane; sugarcane, molasses; sunflower, forage; sunflower, seed; tomato; tomato, concentrated products; and tomato, pomace (wet and dry). It also removes time limitations for tolerances for residues of cyfluthrin on the same commodities.

BAYER - Request to Voluntarily Cancel Certain Pesticide Registration for:
Laser Flea Killer. EPA Reg. No. 003125-00442

BAYER - Filing of Pesticide Petition. Bayer petitioned to remove the time limitations on the established tolerances in or on numerousl raw agricultural commodities, some of which are: alfalfa, forage, at 5.0 ppm; alfalfa, hay, at 10.0 ppm; aspirated grain fractions at 300 ppm; corn, forage (sweet), at 15.0 ppm; corn, fodder (sweet), at 30 ppm; milkfat, at 15.0 ppm.

BAYER - Pesticide Petition for Tolerances for residues in or on the food commodities group citrus fruit at 0.2 ppm; and a maximum residue limit for cyfluthrin on citrus oil and dried pulp at 0.3 ppm with an expiration date of Nov 15, 1997. - FINAL RULE.

BAYER -Pesticide Petition for Tolerances for residues in or on the raw agricultural commodities group citrus, fruits and to establish a maximum residue limit for cyfluthrin on citrus oil and dried pulp.

BAYER - Request to Voluntarily Cancel the products Tempo 2 Lawn.

BAYER - Petition for Time-Limited Pesticide Tolerances for residues in or on the raw agricultural commodities sorghum: fodder (5 ppm), forage (2 ppm) and grain (4 ppm); aspirated grain fractions, 300 ppm; 5 ppm in the fat of cattle, goats, horses, hogs, and sheep; and milkfat at 15 ppm. - FINAL RULE.

BAYER - Petition for Pesticide Tolerance for residues in or on eggs at 0.02 ppm; poultry fat at 0.05 ppm; poultry meat at 0.05 ppm; and poultry meat by-products at 0.05 ppm.

BAYER - Request for increasing tolerances for residues in or on the raw agricultural commodities: to 5 ppm, fat of cattle, goats, hogs, horses, sheep; milkfat at 15.0 ppm,, and 300 ppm in aspirated grain fractions.

BAYER (formerly MILES) - Petition for Time-Limited Pesticide Tolerances for residues in or on the raw agricultural commodities alfalfa: forage at 5 ppm, hay at 10 ppm; sunflowers at 1 ppm; and 1 ppm: fat of cattle, goats, horses, hogs, and sheep with an expiration date of Nov 15, 1997; and an expiration date of July 5, 1999 for residues in or on sweet corn: fodder at 15 ppm, K+CWHR at 0.05 ppm, grain, field and pop at 0.01 ppm. - FINAL RULE.

MILES, INC. - Pesticide Tolerance Petition and a Withdrawal. To amend tolerance to permit residues in or on sweet corn, forage at 54.0 ppm; alfalfa, hay at 10.0 ppm; soybean, forage at 10.0 ppm; alfalfa, forage at 5.0 ppm; soybean, hay at 1.5 ppm; sunflower, forage at 1.0 ppm; sweet corn at 0.05 ppm; soybeans at 0.03 ppm; and sunflower, seed at 0.02 ppm. Miles has withdrawn petition that appeared in the Federal Register of July 13, 1994 (59 FR 35719) for residues in or on sunflower hulls at 2.5 ppm and soybean, hulls at 0.1 ppm.

BAYER - Two Tolerance Petition Amendments; to establish a tolerance in or on corn, rice, and wheat grains at 2 parts per million (ppm), sorghum grain at 4 ppm, aspirated grain fractions at 300 ppm, cattle fat at 6 ppm, and milk fat at 20 ppm resulting from the postharvest treatment of stored grain and grain storage structures. More commodities are listed in the Petition.

MILES, INC. - Petition for Time-Limited Tolerance for residues in or on corn, sweet (K+CWHR); corn, grain, field and pop; and corn, forage and fodder, field, pop, and sweet at 0.01 ppm.- FINAL RULE.

BAYER - Petition for Time-Limited Pesticide Tolerances for residues in or on the raw agricultural commodities tomatoes; carrots; peppers; radishes; meat, fat, and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep; milkfat; and eggs and in the food/feed additive commodities tomato, pomace (dry and wet) and tomato concentrated products.- FINAL RULE.

MILES, INC. - Petition. Renewal of Temporary Tolerances for residues in or on the raw agricultural commodities corn, sweet (K + CWHR); corn, grain, field and pop; corn, forage and fodder, field, pop, and sweet at 0.01 ppm with an expiration date of Dec 31, 1995.

MILES, INC. - Pesticide Petition for tolerances in or on various corn commodities.

MILES, INC. - Petition for Pesticide Tolerance for residues in or on the raw agricultural commodity pears at 0.20 ppm.

MILES, INC. - Pesticide Tolerance Petition to add conditions for use of a dust formulation containing cyfluthrin as a crack or crevice treatment in areas of food/feed- handling establishments. Amended Filing

MILES, INC. (formerly Mobay) - Petition for Pesticide Tolerances in or on the raw agricultural commodities (RAC's) milk, meat, fat, and meat byproducts of cattle and establish a tolerance for milkfat.

MILES, INC. - Petition for Pesticide Tolerances in or on Sugarcane at 0.05 ppm. The Federal Register does not have on-line access to 1993 Notices. This is a Notice published by the USDA noting that Miles, Inc., submitted its petition on Oct 25, 1993 (the date it appeared in the Fed. Reg. might be different.)