Document ID: EPA-HQ-OPP-2015-0658-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-11-23T05:00Z

EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE
PETITION

Docket ID Number: EPA-HQ-OPP-2015-0658

EPA Registration Division Contact: Sidney Jackson (703) 305-7610

Interregional Research Project Number 4 

Pesticide Petition Number: 5E8399

EPA has received a pesticide petition (PP# 5E8399) from the
Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters,  Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, NJ 08450  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 flumioxazin,
2-[7-fluoro-3,4-dihydro-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 commodities: caneberry, subgroup 13-07A at 0.4 parts per
million (ppm); 

brassica, head and stem, subgroup 5A at 0.02 ppm; clover, forage at 0.02
ppm; clover, hay at 0.15 ppm; fruit, citrus, group 10-10 at 0.02 ppm;
citrus oil at 0.1 ppm; vegetable, fruiting group 8-10 at 0.02 ppm;
fruit, pome, group 11-10 at 0.02 ppm; fruit, stone, group 12-12 at 0.02
ppm; nut, tree, group 14-12 at 0.02 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.02 ppm; berry, low growing,
subgroup 13-07G at 0.07 ppm; and onion, bulb, subgroup 3-07A at 0.02
ppm.

The petitioner is also proposing revocation of the existing tolerance 
for residue of the herbicide flumioxazin,
2-[7-fluoro-3,4-dihydro-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 commodities: cabbage at 0.02 ppm; cabbage, Chinese, napa at
0.02 ppm, fruit, pome group 11 at 0.02 ppm, fruit, stone, group 12 at
0.02 ppm, garlic at 0.02 ppm, grape at 0.02 ppm,  nut, tree group 14 at
0.02 ppm, okra at 0.02 ppm, onion, bulb at 0.02 ppm, pistachio 0.02 ppm
shallot bulb at 0.02 ppm, strawberry at 0.07 ppm and vegetable, fruiting
group 8 at 0.02 ppm because flumioxazin tolerances for these commodities
are superseded by above requested tolerances.  EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the petition. Additional data may be needed
before EPA rules on the petition.

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 

	1. Plant metabolism.  The metabolism of flumioxazin is adequately
understood for the purpose of granting the proposed tolerances.

	2.  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 limit of quantitation (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.

3. 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 April 5, 2013
(78 FR 20461) (FRL-9381-7).

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.  

The newly petitioned crops and the proposed tolerances will have
negligible impact on dietary exposure.

Food.  Dietary exposures are reviewed in 78 FR 20461 (FRL-9381-7).   

Drinking water.  Drinking water exposures are reviewed in 78 FR 20461

    (FRL-9381-7).

2. Non-dietary exposure.  Non-dietary (residential and recreational)
aggregate exposures to flumioxazin may occur because people may swim in
flumioxazin-treated water bodies or come into contact with treated turf
in residential or recreational (golf) areas.  Aggregate exposure
scenarios were conducted and reported previously and are not being
revisited herein because the proposed tolerances will have no impact on
non-dietary exposures.  

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. 

Acute Risk.  See 78 FR 20461 (FRL-9381-7)  

Chronic Risk.  See 78 FR 20461 (FRL-9381-7).  

2. Infants and children.  See 78 FR 20461 (FRL-9381-7)

i. 	Acute Risk. See 78 FR 20461 (FRL-9381-7)

ii 	Chronic Risk.  See 78 FR 20461 (FRL-9381-7)

F. International Tolerances. No Codex Maximum Residue Limits (MRL) for
flumioxazin have been established.