Structure:

Structure:

IR-4. New tolerance proposed. PP 6E7168. Proposes to establish a tolerance for residues of fluroxypyr MHE, and its metabolite fluroxypyr (expressed as combined residues of total fluroxypyr) in or on food commodities. See November 21, 2006 submission from Down AgroSciences to EPA.

Adequate enforcement method for the combined residues of total fluroxypyr is available to enforce the tolerance expression in or on food. The analytical method uses capillary GC and mass selective
detection (MSD) with LOQ of 0.01 ppm. Fluroxypyr has also been tested through the Food and Drug Administration (FDA), Multi-residue Methodology, Protocols C, D, and E. The results have been published in the FDA Pesticide Analytical Manual, volume 1.

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

Pesticide Emergency Exemptions:

• Colorado. Crisis: On May 16, 2005, for the use of fluroxypyr on onions to control volunteer potatoes. This program ended on July 15, 2005. Contact: (Stacey Groce).

Jan 26, 2005

OPP-2005-0008

Pesticide Tolerances for Emergency Exemptions. FINAL RULE.
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the herbicide fluroxypyr 1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on

This tolerance will expire and is revoked on June 30, 2007.

Although this tolerance will expire and is revoked on June 30, 2007, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on onion after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions identified in the state of Colorado, EPA has not made any decisions about whether fluroxypyr 1-methylheptyl ester meets EPA's registration requirements for use on onion or whether a permanent tolerance for this use would be appropriate.

One Pesticide Emergency Exemption.
• Colorado - Crisis: On June 21, 2004, for the use of fluroxypyr on onions to control volunteer potatoes. This program ended on July 21, 2004. Contact: (Stacey Groce)

Extension of Tolerances for Emergency Exemptions. FINAL RULE. EPA has authorized under FIFRA
section 18 the use of fluroxypyr 1-methylheptyl ester on field corn and sweet corn for control of volunteer potatoes in Washington, Oregon, Idaho, and Wisconsin. This regulation extends time-limited tolerances for residues of the herbicide fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr in or on

for an additional 3-year period. These tolerances will expire and are revoked on December 31, 2006. Time-limited tolerances were originally published in the Federal Register of August 5, 1998

Dow AgroSciences. Pesticide tolerance. FINAL RULE. Tolerances are established for combined residues of fluroxypyr 1-methylheptyl ester and its metabolite Fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic acid], free and conjugated, all expressed as fluroxypyr.
-- 870.4300 Carcinogenicity--Rats NOAEL = 100 mg/kg/day. LOAEL = 500 mg/kg/day based on chronic progressive kidney glomerulonephropathy. no evidence of carcinogenicity
-- 870.3800 Reproduction and fertility Parental/Systemic NOAEL = 100 mg/kg/day effects (Males) / 500 mg/kg/day (Females) LOAEL = 500 mg/kg/day (Males) / 1,000 mg/kg/ day (Females), based on kidney effects (M&;F) and increased deaths (F).

Conditions:
i. Additional field trials - conduct and submit four (4) additional field trials in Regions III (1 trial), V(1 trial), XI(1 trial), and XII(1 trial). Residue analysis of sweet corn field trial samples should avoid using the DowElanco Method ACR 90.8, due to matrix interference cited in PP#2G04066.
ii. Storage stability data - submit to support the sweet corn field trial data.
iii. 28-Day Inhalation Toxicity Study

Fluroxypyr 1- methylheptyl ester and Fluroxypyr. Pesticide petition for several tolerances.
-- Reproductive and developmental toxicity. The first in Wistar rats showed no effect on fertility or reproductive performance and had a NOAEL of 500 mg/kg/day (highest dose tested). The second study in Sprague-Dawley rats showed a parental NOAEL for systemic effects of 100 mg/kg/day in male rats and 500 mg/kg/ day in female rats. The NOAEL for reproductive effects was 750 mg/kg/ day for males and 1,000 mg/kg/day for females (highest dose tested). The NOAEL for neonatal effects was 500 mg/kg/day.
-- Subchronic toxicity. Fluroxypyr MHE showed a NOAEL of 1,000 mg/ kg/day in a 90-day rat dietary study and a 21-day rabbit dermal study. Ninety day feeding studies with fluroxypyr showed NOAELs of 80 mg/kg/ day (Wistar rats), 700 mg/kg/day (Fischer 344 rats), 1,342 mg/kg/day (male mice), and 1,748 mg/kg/day (female mice). In a 4-week dietary, range finding study with fluroxypyr in dogs the NOAEL found was > 50 mg/kg/day.
-- Metabolite toxicology. Administration of fluroxypyr, as the acid or methylheptyl ester in a variety of toxicological studies, has produced similar effects. The principal response to sufficiently high dosages, whether administered over the short-term or, in some cases, over a lifetime, was nephrosis. Fluroxypyr is an organic acid that is actively excreted into the urine by the kidney. Thus, the target organ and dose response relationship for fluroxypyr toxicity is entirely consistent with the data on the toxicokinetics of fluroxypyr. Metabolism studies have shown that fluroxypyr MHE is rapidly and completely hydrolyzed to fluroxypyr acid and methylheptanol.

Fluroxypr: Emergency Exemptions for pesticide use.

• Kansas Department of Agriculture. EPA authorized the use of fluroxypr on pastures and rangeland to control the noxious weed species sericea lespedeza (Lespedeza cuneata); March 30, 2003 to July 30, 2003.
• Oregon Department of Agriculture. EPA authorized the use of fluroxypyr on sweet corn and field corn to control volunteer potatoes; April 15, 2003 to August 1, 2003.
• Washington Department of Agriculture. EPA authorized the use of fluroxypyr on sweet corn and field corn to control volunteer potatoes; April 15, 2003 to August 1, 2003.

Request to Delete Certain Uses in Certain Pesticide Registrations

Dow AgroSciences. Petition for pesticide tolerances for combined residues of fluroxypyr 1-methylheptyl ester (MHE) and its metabolite fluroxypyr, all expressed as fluroxypyr

EPA approved the use of Fluroxypyr for 1 Emergency Exemption.

-- Kansas: Crisis: On July 8, 2002, for the use of fluroxypur [sic - fluroxypyr] on grain sorghum to control kochia. This program ended on July 23, 2002.

Pesticide Tolerances for Emergency Exemptions for the state of Kansas for combined residues of fluroxypyr [1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2- pyridinyl)oxy)acetic acid] in or on

The tolerances will expire and are revoked on December 31, 2005. A summary of the toxicological dose and endpoints for fluroxypyr for use in human risk assessment is discussed in Unit IV.A. of the Federal Register of September 17, 2001 - see below.

Emergency Exemptions for pesticide use.

• Idaho Department of Agriculture - EPA authorized the use of fluroxypyr on sweet corn and field corn to control volunteer potatoes; May 20, 2002 to August 1, 2002.
• Oregon Department of Agriculture - EPA authorized the use of fluroxypyr on sweet corn and field corn to control volunteer potatoes; May 13, 2002 to August 1, 2002.
• Washington Department of Agriculture - Specific: EPA authorized the use of fluroxypyr on sweet corn and field corn to control volunteer potatoes; May 13, 2002 to August 1, 2002.

Fluroxypyr 1-methylheptyl ester and its metabolites. Extension of Tolerances for Emergency Exemptions. FINAL RULE.. EPA has authorized under FIFRA section 18 the use of fluroxypyr 1-methylheptyl ester on grass pasture and rangeland for control of sericea lespedeza (Lespedeza cuneata) in Kansas. This regulation extends time-limited tolerances for combined residues of the herbicide fluroxypyr 1-methylheptyl ester 1- methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2- pyridinyl)oxy)acetic acid in or on

These tolerances will expire and are revoked on December 31, 2004. Time-limited tolerances were originally published in the Federal Register of September 17, 2001.

• 8 Pesticide Emergency Exemptions. EPA authorized use in:
• Idaho: on field corn to control volunteer potatoes; May 3, 2001 to August 1, 2001.
• Idaho: on sweet corn to control volunteer potatoes; May 3, 2001 to August 1, 2001.
• Oregon & Washington : on field corn to control volunteer potatoes; May 4, 2001 to August 1, 2001.
• Oregon & Washington: on sweet corn to control volunteer potatoes; May 4, 2001 to August 1, 2001.
• Wisconsin: on field corn to control volunteer potatoes; June 7, 2001 to July 15, 2001.
• Wisconsin: on sweet corn to control volunteer potatoes; July 27, 2001 to August 15, 2001.

Pesticide Tolerances for Emergency Exemptions. - FINAL RULE. This regulation establishes time-limited tolerances for the combined residues of fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated, all expressed as fluroxypyr in or on GRASS:, forage AT 120 PPM, and, hay AT 160 PPM, and modifies the existing permanent tolerances for milk AT 0.3 PPM, and for kidney of cattle, goat, hog, horse, and sheep AT 1.5 PPM. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide on pastures and rangeland. The tolerances will expire and are revoked on June 30, 2003. Comments on this Final Rule must be received by EPA on or before November 16, 2001.
-- Chronic dietary all populations; 28-day dog range-finding feeding study LOAEL = 150 mg/kg/day based on histopathological lesions in the kidneys, decreased testes weights, and increased adrenal weights in both sexes.
-- Developmental toxicity studies. The developmental (fetal) NOAEL was 250 mg/kg/day, based on reduced ossification at the LOAEL of 500 mg/kg/day.
-- Reproductive toxicity study. In the 2-generation reproductive toxicity study in rats, the maternal (systemic) NOAEL was 100 mg/kg/ day, based on increased kidney weights and kidney histopathology at the LOAEL of 500 mg/kg/day.

Extension of Tolerances for Emergency Exemptions. - FINAL RULE. EPA has authorized the use of fluroxypyr 1-methylheptyl ester on field corn and sweet corn for control of volunteer potatoes in Washington, Oregon, Idaho, and Wisconsin. This regulation extends time-limited tolerances for residues of the herbicide fluroxypyr 1-methylheptyl ester ((4- amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid, 1-methylheptyl ester and it's metabolite fluroxypyr in or on

for an additional 2-year, 1-month period. These tolerances will expire and are revoked on December 31, 2003. Time-limited tolerances were originally published in the Federal Register on August 5, 1998

• Pesticide Emergency Exemptions. US EPA authorized:
• Idaho: on 5/19/00, the use of fluroxypyr on sweet corn to control volunteer potatoes. This program ended on 6/2/00. On 6/9/00, the use of fluroxypyr on field corn to control volunteer potatoes. This program ended on 8/1/00. EPA authorized the use of fluroxypyr on field corn to control volunteer potatoes; 6/9/00 to 8/1/00.
• Oregon: The use of fluroxypyr on field corn to control volunteer potatoes; 4/15/00 to 8/1/00. EPA authorized the use of fluroxypyr on sweet corn to control volunteer potatoes; 4/15/00 to 8/1/00.
• Washington: The use of fluroxypyr on field corn to control volunteer potatoes; 3/24/00 to 8/1/00. EPA authorized the use of fluroxypyr on sweet corn to control volunteer potatoes; 3/24/00 to 8/1/00.
• Wisconsin: The use of fluroxypyr on field corn to control volunteer potatoes; 6/1/00 to 7/15/00

Extension of Tolerance for Emergency Exemptions. - FINAL RULE. This regulation extends time-limited tolerances for the combined residues of the herbicide fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr in or on

for an additional 2-year period. These tolerances will expire and are revoked on December 1, 2001.

• DOW AGRO - Approval of TWO Pesticide Product Registrations:
• Starane F Technical for manufacturing use only. EPA Reg. Number 62719-285.
• Starane EC for postemergence control of annual and perennial broadleaf weeds and volunteer potatoes in

  small grains, fallow cropland, and on farm non-cropland.

  EPA File Reg. Number 62719- 286.

DOW AGRO - Pesticide Tolerance. - FINAL RULE. This regulation establishes tolerances for combined residues of fluroxypyr and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in or on the raw agricultural commodities (RAC) wheat, barley, and oats as follows: 0.5 ppm (grain), 12 ppm (straw and forage), 20 ppm (hay), and 0.6 ppm (aspirated grain fractions). Because residues of fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated, may occur in animal feeds derived from wheat, barley, and oats, the following tolerances are also being established:

DOW ELANCO - Amendment to peticide tolerance petition published in F.R. of December 17, 1997; for the combined residues of the herbicide fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr [((4- amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in or on the raw agricultural commodities wheat, barley, and oats as follows:

(Because residues of fluroxypyr or its metabolite, free and conjugated, may occur in animal feeds derived from wheat, barley, and oats, the following tolerances are also being proposed:

Pesticide Tolerances for Emergency Exemptions.- FINAL RULE. This regulation establishes time-limited tolerances for the combined residues of fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr in or on wheat, barley, field corn, and sweet corn.

These tolerances will expire and are revoked on December 1, 1999.

DOW ELANCO - Pesticide Tolerance Petition; for residues of fluroxypyr methylheptyl ester (MHE) and its only significant metabolite fluroxypyr, free and conjugated, all expressed as fluroxypyr in or on the raw agricultural commodities wheat, barley, and oats as follows:

Because residues of fluroxypyr MHE or fluroxypyr, free or conjugated, may occur in animal feeds derived from wheat, barley, and oats, the following tolerances are also being proposed: