Flumioxazin (IR-4; Valent). March 17, 2004. Pesticide tolerance petition. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Flumioxazin (IR-4; Valent). March 17, 2004. Pesticide tolerance petition. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/March/Day-17/p552.htm

[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Notices]
[Page 12683-12687]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr04-72]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0047; FRL-7346-8]
Flumioxazin; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2004-0047, must be
received on or before April 16, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 12684]]
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0047. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0047. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0047. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access''
[[Page 12685]]
system. If you send an e-mail comment directly to the docket without
going through EPA's electronic public docket, EPA's e-mail system
automatically captures your e-mail address. E-mail addresses that are
automatically captured by EPA's e-mail system are included as part of
the comment that is placed in the official public docket, and made
available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0047.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2004-0047. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); 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.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 4, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions
The petitioner summary of the pesticide petitions is printed below
as required by FFDCA section 408(d)(3). The summary of the petitions is
prepared by the petitioner and represents the view of the petitioner.
The summary may have been edited by EPA if the terminology used was
unclear, the summary contained extraneous mateial, or the summary
unintentionally made the reader conclude that the findings reflected
EPA's position and not the position of the petitioner. The petition
summary announces the availability of a description of the analytical
methods available to EPA for the detection and measurement of the
pesticide chemical residues or an explanation of why no such method is
needed.

Interregional Research Project Number 4 (IR-4)
PP 3E6777, 3E6788, and 3E6779
EPA has received pesticide petitions (PP 3E6777, 3E6788, and
3E6779) from IR-4, 681 U.S. Highway #1 South, North Brunswick,
NJ 08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21
U.S.C. 346a(d), to amend 40 CFR 180.568 by establishing tolerances for
residues of 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 following raw agricultural commodities:
1. PP 3E6777 proposes tolerances for peppermint, tops; peppermint,
oil; spearmint, tops; and spearmint, oil at 0.04 parts per million
(ppm).
2. PP 3E6788 proposes tolerances for onion, dry bulb; garlic, bulb;
and shallot, bulb at 0.02 ppm.
3. PP 3E6779 proposes tolerances for vegetable, tuberous and corm
subgroup 1C at 0.02 ppm.

EPA has determined that the petitions contain 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 support granting of the
petitions. Additional data may be needed before EPA rules on the
petitions. This notice includes a summary of the petitions prepared by
Valent USA Corporation, P.O. Box 8025, Walnut Creek, CA 94596-8025.

A. Residue Chemistry

1. Plant metabolism. The metabolism of flumioxazin is adequately
understood for the purpose of 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 quantification (LOQ) of flumioxazin
in the methods is 0.02 ppm which will allow monitoring of food
[[Page 12686]]
with residues at the levels proposed for the tolerances.

3. Magnitude of residues. Residue data on potato, onion, and mint
have been submitted which adequately supports the requested tolerances.

B. Toxicological Profile

The toxicological profile for flumioxazin which supports these
petitions for tolerances was previously published in the Federal
Register of April 18, 2001 (66 FR 19870) (FRL-6778-5).

C. Aggregate Exposure

1. Dietary exposure--i. Food. Acute and chronic dietary analyses
were conducted to estimate exposure to potential flumioxazin residues
in/on the following crops: Peanuts and soybeans (existing tolerances),
cotton, grapes, almond, pistachio, and sugarcane (tolerances pending),
vegetable, tuberous and corm (Subgroup 1C), onion, dry bulb and mint
(tolerances proposed in the current petitions), and nut, tree (Group
14), fruit, pome (Group 11), and fruit, stone (Group 12) (tolerances to
be proposed in the future). The Cumulative and Aggregate Risk
Evaluation System (CARES) Version 1.1 was used to conduct this
assessment. Proposed tolerances and conservative estimates for
percentages of the crop treated were used in these assessments. No
adjustments were made for common washing, cooking or preparation
practices. Exposure estimates for water were made based upon modeling
General Expected Environmental Concentration (GENEEC 1.2).
ii. Drinking water. Since flumioxazin is applied outdoors to
growing agricultural crops, the potential exists for the parent or its
metabolites to reach ground water or surface water that may be used for
drinking water. Because of the physical properties of flumioxazin, it
is unlikely that flumioxazin or its metabolites can leach to potable
ground water. To quantify potential exposure from drinking water,
surface water concentrations for flumioxazin were estimated using
GENEEC 1.2. Because KOC could not be measured directly in
adsorption-desorption studies because of chemical stability, GENEEC
values representative of a range of KOC values were modeled.
The simulation that was selected for these exposure estimates used an
average KOC of 385, indicating high mobility. The peak
GENEEC concentration predicted in the simulated pond water was 9.8
parts per billion (ppb). Using standard assumptions about body weight
and water consumption, the acute exposure from this drinking water
would be 0.00028 and 0.00098 milligrams/kilogram/day (mg/kg/day) for
adults and children, respectively. The 56-day GENEEC concentration
predicted in the simulated pond water was 0.34 ppb.

2. Non-dietary exposure. Flumioxazin is proposed only for
agricultural uses and no homeowner or turf uses. Thus, no non-dietary
risk assessment is needed.

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
include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments.
Although the Agency has some information in its files that may turn out
to be helpful in eventually determining whether a pesticide shares a
common mechanism of toxicity with any other substances, EPA does not at
this time have the methodologies to resolve the complex scientific
issues concerning common mechanism of toxicity in a meaningful way for
most registered pesticides.

E. Safety Determination

1. U.S. population. The potential acute exposure from food to the
U.S. population and various non-child/infant population subgroups will
utilize at most 14.2% of the acute reference dose (aRfD). Addition of
the worse case, dietary exposure from water (0.00028 mg/kg/day)
increases this exposure at the 99.9th percentile to 23.7% of the aRfD.
The Agency has no cause for concern if total acute residue contribution
is less than 100% of the aRfD, because the aRfD represents the level at
or below which daily aggregate exposure over a lifetime will not pose
appreciable risk to human health. Therefore, it can be concluded that
there is a reasonable certainty that no harm will result to the overall
U.S. population from aggregate, acute exposure to flumioxazin residues.

2. Chronic risk. The potential chronic exposure from food to the
U.S. population and various non-child/infant population subgroups will
utilize at most 2.5% of the chronic reference dose (cRfD). The
population subgroup with the highest exposure was the U.S. population,
western states. Addition of the worse case, dietary exposure from water
(0.0000097 mg/kg/day) increases this exposure at the 100th percentile
to 3.0% of the cRfD. The Agency has no cause for concern if total
chronic residue contribution is less than 100% of the cRfD, because the
cRfD represents the level at or below which daily aggregate exposure
over a lifetime will not pose appreciable risk to human health.
Therefore, it can be concluded that there is a reasonable certainty
that no harm will result to the overall U.S. population from aggregate,
chronic exposure to flumioxazin residues.

3. Infants and children--i. Safety factor for infants and children.
The FQPA safety factor has been retained at 10X in assessing the risk
posed by flumioxazin. The reasons for retaining the 10X safety factor
are as follows. First, there is evidence of increased susceptibility of
rat fetuses to in utero exposure to flumioxazin by the oral and dermal
route in the prenatal developmental toxicity studies in rats. In
addition, there is evidence of increased susceptibility of young
animals exposed to flumioxazin in the 2-generation reproduction
toxicity study in rats. Finally, there is concern for the severity of
the effects observed in fetuses and young animals when compared to
those observed in the maternal and parental animals.
Since the additional 10X safety factor has been retained to account
for the apparent increased susceptibility from prenatal or postnatal
exposures to flumioxazin, it would be appropriate to apply the extra
10X safety factor to only selected subpopulations, e.g. infants and
children <6 years old and females >13 years old. For these assessments,
however, the 10X safety factor has been applied to all population
subgroups for all exposure durations (acute and chronic), thus making
these assessments additionally conservative.

ii. Acute risk. The potential acute exposure from food to children
1-2 years old (the most highly exposed child/infant subgroup) will
utilize at most 26.3% of the aRfD. Addition of the worse case, dietary
exposure from water (0.00098 mg/kg/day) increases this exposure at the
99.9th percentile to 59% of the aRfD. Therefore, it can be concluded
that there is a reasonable certainty that no harm will result to
infants and children from aggregate, acute exposure to flumioxazin
residues.

iii. Chronic risk. The potential chronic exposure from food to
children 1-2 years old (the most highly exposed child/infant subgroup)
will utilize at most 2.4% of the cRfD. Addition of the worse case,
dietary exposure from water (0.000034 mg/kg/day) increases this
exposure at the 100th percentile to 4.2% of the cRfD. Therefore, it can
be concluded that there is a reasonable
[[Page 12687]]
certainty that no harm will result to infants and children from
aggregate, chronic exposure to flumioxazin residues.

F. International Tolerances
Flumioxazin has not been evaluated by the Joint Meeting on
Pesticide Residues and there are no Codex Maximum Residue Limits (MRL)
for flumioxazin. MRL values have been established to allow the
following uses of flumioxazin in the following countries:
1. Argentina, soybean at 0.015 ppm and sunflower at 0.02 ppm.
2. Brazil, soybean at 0.05 ppm.
3. France, grape at 0.05 ppm.
4. Paraguay, soybean at 0.015 ppm.
5. South Africa, soybean at 0.02 ppm and groundnut at 0.02 ppm.
6. Spain, soybean at 0.05 ppm and peanut at 0.05 ppm.

[FR Doc. E4-552 Filed 3-16-04; 8:45 am]
BILLING CODE 6560-50-S