FILE NAME: Company Notice of Filing 

EPA Registration Division contact: Bethany Benbow (703) 347-8072

[1F7886] 

SUMMARY OF PETITIONS 

EPA has received a pesticide petition (1F7886) from Valent U.S.A. Corporation, 1600 Riviera Avenue, 

Suite 200, Walnut Creek, CA 94596, proposing, pursuant to section 408(d) of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180, by establishing tolerances 

for residues of the herbicide chemical 

flumioxazin,2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione: in or on the raw agricultural commodities and processing fractions in Crop 

Subgroup 6C [Dried shelled pea and bean (except soybean)], at 0.1 parts per million (ppm) for seed; 

Crop Subgroup 20A (Rapeseed), at 0.35 ppm for seed, at 0.04 ppm for meal, and at 0.02 ppm for 

refined oil; Crop Subgroup 20B (Sunflower), at 0.5 ppm for seed, at 0.03 ppm for meal, and at 0.02 

ppm for refined oil; and Wheat, at 0.35 ppm for grain, at 5 ppm for straw, at 0.02 ppm for forage 

(pre-emergence), at 0.02 ppm for hay (pre-emergence), at 0.35 ppm for bran, at 0.05 ppm for flour, at 

0.35 ppm for germ, at 0.08 ppm for middlings, at 0.11 ppm for shorts and at 110 ppm for Aspirated 

Grain Fractions. The petitioner is also proposing revocation of the existing tolerance for residue of the 

herbicide chemical flumioxazin, 

2-[7-fluoro-3,4dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole

1,3(2H)-dione, in or on the raw agricultural commodity beans, dry seed, because a tolerance on Crop 

Subgroup 6C is being requested. EPA has determined that the petition contains data or information 

regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 

evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the 

petition. Additional data may be needed before EPA rules on the petition. 

A. Residue Chemistry

一 Plant metabolism. The metabolism of flumioxazin is adequately understood for the purpose of 

granting the proposed tolerances. 

一 Analytical method. Practical analytical methods for detecting and measuring levels of 

flumioxazin have been developed and validated in/on all appropriate agricultural commodities and 

respective processing fractions. The LOQ of flumioxazin in the methods is 0.02 ppm which will 

allow monitoring of food with residues at the levels proposed for the tolerances. 

一 Magnitude of residues. Residue data has been submitted which adequately support the 

requested tolerances. 

B. Toxicological Profile

The toxicological profile for flumioxazin, which supports this petition for tolerances was 

published in the Federal Register on March 31, 2004 (69 FR 16823)(FRL-7351-2). Immunotoxicity and 

neurotoxicity studies have been submitted to the Agency to fulfill revised FIFRA 40 CFR part 158.340 

data requirements. The results of these studies show no indication of immunotoxicity or neurotoxicity 

and do not result in any changes to the toxicology endpoints used for risk assessment purposes.
 

C. Aggregate Exposure 

1. Dietary exposure. A Tier 1 dietary (food and water) exposure assessment was conducted to 

evaluate the potential risk due to acute and chronic dietary exposure of the 

U.S. population and various subpopulations to residues of flumioxazin. 

i. Food. Dietary exposures were calculated using DEEM-FCID version 2.16. Key assumptions for 

the Tier 1 assessment are tolerance-level residues on all commodities, 100% crop treated and 

default processing factors for processed commodities without processing data. The analysis 

included all existing tolerances in addition to the currently proposed tolerances. 

ii.Drinking water. The current assessment also includes potential residues from aquatic uses of 

flumioxazin to conservatively estimate potential exposures from drinking water. For the acute 

assessment, the major source of flumioxazin exposure to drinking water was assumed to be the 

maximum labeled treatment rate of 400 ppb for treated water bodies. For the chronic 

assessment, the drinking water concentration of flumioxazin and its major hydrolysis 

degradates was assumed to be 142 ppb based on the 30-day average concentration for the 

aquatic use. 

2. Non-dietary exposure. Non-dietary (residential) aggregate exposures to Flumioxazin may occur 

because people may swim in flumioxazin-treated water bodies. Short-term aggregate exposure 

scenarios were constructed by combining chronic dietary exposures with those estimated for adults or 

children swimming in treated water bodies. 

D. Cumulative Effects 

Section 408(b)(2)(D)(v) requires that the Agency must consider "available information" 

concerning the cumulative effects of a particular pesticide's residues and "other substances that have a 

common mechanism of toxicity." Available information in this context includes not only toxicity, 

chemistry, and exposure data, but also scientific policies and methodologies for understanding common 

mechanisms of toxicity and conducting cumulative risk assessments. EPA does not have, at this time, 

available data to determine whether flumioxazin has a common mechanism of toxicity with other 

substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this 

tolerance action, EPA has not assumed that flumioxazin has a common mechanism of toxicity with 

other substances. 

E. Safety Determination 

1. U.S. population. 

i. Acute Risk. The acute dietary exposure estimate to flumioxazin residues in food and water at 

the 95th

th 

percentile for females 13-49 years old was calculated to be, at most, 67.4% of the 

acute Population Adjusted Dose (aPAD). This is the only population subgroup with an 

identified acute toxicity endpoint. Residues from water are the primary contributor to the 

exposure. The aPAD was defined using the NOEL from an oral developmental study in rats 

and includes an uncertainty factor of 100 to account for intra- and inter-species variation 

(aPAD = 0.03 mg/kg/day). Aggregate exposures below 100% of the aPAD are generally 

considered to represent a reasonable certainty of no harm to exposed populations. 
ii.Chronic Risk. The potential chronic exposure from food and water to the U.S. Population and 

various non-child/infant population subgroups will utilize at most 19.1% of the cPAD. 

Residues from water are the primary contributor to the exposure. The cPAD was defined using 

the NOEL from a rat two-year chronic/oncogenicity study and includes an uncertainty factor of 

100 to account for intra- and inter-species variation (cPAD = 0.02 mg/kg/day). Aggregate 

exposures below 100% of the aPAD are generally considered to represent a reasonable 

certainty of no harm to exposed populations. 

2. Infants and children. 

i. Safety Factor for Infants and Children. EPA has determined that the special 10x SF to protect 

infants and children should be removed [Federal Register of March 31, 2004 (69 FR 16823) 

(FRL-7351-2)]. The FQPA factor has been removed because developmental toxicity and 

offspring toxicity NOAELs/LOAELs are well characterized; there is a well-defined 

dose-response curve for the cardiovascular effects; and the endpoints of concern used for 

overall risk assessments are appropriate for the route of exposure and population subgroups. 

ii.Acute Risk. No acute endpoint has been identified for infants and children. Therefore, no 

assessment of acute exposure from food or water to this subgroup is required. 

iii. Chronic Risk. The potential chronic dietary exposure from food and water to children 1-2 

years old (the most highly exposed child/infant subgroup) will utilize at most 54% of the 

cPAD. Aggregate exposures below 100% of the cPAD are generally considered to represent a 

reasonable certainty of no harm to exposed populations. Aggregation of dietary exposures with 

residential exposures (e.g. swimming) in treated bodies of water also results in acceptable 

risks. MOEs for the various aggregate exposure scenarios range from 450 to 620. MOEs 

greater than 100 indicate a reasonable certainty of no harm resulting from the associated 

exposures. 

F. International Tolerances 

Flumioxazin has not been evaluated by the JMPR and there are no Codex Maximum Residue 

Limits (MRL) for flumioxazin.