[Federal Register Volume 69, Number 235 (Wednesday, December 8, 2004)]
[Notices]
[Pages 71045-71049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26819]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0398; FRL-7689-1]


Flumioxazin; Notice of Filing a Pesticide Petition to Establish 
aTolerance 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 apesticide 
petition proposing the establishment of regulations for residuesof a 
certain pesticide chemical in or on various foodcommodities.

DATES: Comments, identified by docket identification(ID) number OPP-
2004-0398, must be received on or before January 7, 2005.

ADDRESSES:  Comments may be submitted electronically, bymail, or 
through hand delivery/courier. Follow the detailed instructionsas 
provided in Unit I. of the SUPPLEMENTARYINFORMATION.

FOR FURTHER INFORMATION CONTACT:  Joanne I. Miller,Registration 
Division (7505C), Office of Pesticide Programs, EnvironmentalProtection 
Agency, 1200 Pennsylvania Ave., NW.,Washington, DC20460-0001; telephone 
number: (703) 305-6224; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are 
anagricultural 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 32532)
     This listing is not intended to be exhaustive, but rather 
providesa guide for readers regarding entities likely to be affected by 
thisaction. Other types of entities not listed in this unit could also 
beaffected. The North American Industrial Classification System (NAICS) 
codeshave been provided to assist you and others in determining whether 
thisaction might apply to certain entities. If you have any questions 
regardingthe applicability of this action to a particular entity, 
consult the personlisted under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other RelatedInformation?

    1. Docket. EPA has established an official publicdocket for this 
action under docket ID number OPP-2004-0398.The official public docket 
consists of the documents specificallyreferenced in this action, any 
public comments received, and otherinformation related to this action. 
Although, a part of the officialdocket, the public docket does not 
include Confidential BusinessInformation (CBI) or other information 
whose disclosure is restricted bystatute. The official public docket is 
the collection of materials that isavailable for public viewing at the 
Public Information and RecordsIntegrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. BellSt., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m.,Monday through Friday, 
excluding legal holidays. The docket telephonenumber 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

[[Page 71046]]

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 on 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-2004-0398. 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 [email protected], 
Attention: Docket ID number OPP-2004-0398. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' 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-2004-0398.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0398. 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.

[[Page 71047]]

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: November 24, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

     The petitioner's summary of the pesticide petition is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petition was prepared by Valent U.S.A. Corporation and represents the 
view 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.

 Valent U.S.A. Corportion

 PP 4F6829

     EPA has received a pesticide petition (4F6829) from Valent U.S.A. 
Corporation, 1600 Riviera Ave., 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 a tolerance 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-tetrahydro-1H-isoindole-1,3(2H)-dione, in or 
on the following raw agricultural commodities: Fruit, pome (Crop Group 
11) at 0.02 parts per million (ppm) and fruit, stone (Crop Group 12) at 
0.02 ppm. 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 support 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 the proposed tolerances.
    2. Analytical method. Practical analytical methods for detecting 
and measuring levels of flumioxazin have been developed and validated 
in or 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 on apples, pears, plums, 
peaches, and cherries (sweet and tart) have been submitted which 
adequately support the requested tolerances. Processing studies were 
conducted with apples and plums. No residues of flumioxazin were 
detected in any of the raw agricultural commodities or processing 
commodities collected from these studies even when orchards were 
treated at an exaggerated (2x) rate. No tolerances are proposed for 
apple or plum processing commodities.

B. Toxicological Profile

     The toxicological profile for flumioxazin which supports this 
petition 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. Acute and chronic dietary analyses were 
conducted to estimate exposure to potential flumioxazin residues in or 
on the following crops: Peanuts and soybeans (existing tolerances); 
cotton, grapes, almond, pistachio, and sugarcane, vegetable, tuberous 
and corm (Subgroup 1C), onion, dry bulb and mint (tolerances pending); 
nut, tree (Group 14), (tolerances to be proposed in the future); and 
fruit, pome (Group 11) and fruit, stone (Group 12) (tolerances proposed 
in the current petition). 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 
percent 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 Generic 
Expected Environmental Concentration (GENEEC 1.2).
    i. Food--a. Acute. The acute dietary exposure estimate of 
flumioxazin residues in food at the 99.9th percentile was 
calculated to be, at most, 26.3% of the acute reference dose (aRfD) 
with a margin of exposure (MOE) of 3,797. The population subgroup with 
the highest exposure was children 1-2 years old. The aRfD was defined 
as the no observed adverse effect level (NOAEL) from an oral 
developmental study in rats and includes an uncertainty factor of 100 
to account for intraspecies and interspecies variation and an 
additional 10-fold uncertainty factor for FQPA (NOAEL = 3 milligrams/
kilogram body weight (mg/kg bwt/day), aRfD = 0.003 mg/kg/day).
    b. Chronic. The chronic dietary exposure estimate of flumioxazin 
residues in food at the 100th percentile was calculated to 
be, at most, 2.5% of the chronic reference dose (cRfD) with a MOE of 
40,000. The population subgroup with the highest exposure was the 
general U.S. population. The cRfD was defined as the NOAEL from a rat 
2-year chronic/oncogenicity study and includes an uncertainty factor of 
100 to account for intraspecies and interspecies variation and an 
additional 10-fold uncertainty factor for Food Quality Protection Act 
(FQPA) (NOAEL = 2 mg/kg bwt/day, cRfD = 0.002 mg/kg/day).
    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 mg/kg/
day for

[[Page 71048]]

 adults and children, respectively. The 56-day GENEEC concentration 
predicted in the simulated pond water was 0.34 ppb. Chronic exposure 
from this drinking water would be 0.0000097 and 0.000034 mg/kg/day for 
adults and children, respectively; 1.7% of the chronic population 
adjusted dose (cPAD) of 0.002 mg/kg/day for children. Based on this 
worse case analysis, the contribution of drinking water to the dietary 
exposure is comparable to that from food, but the risk is still 
negligible.
    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--i. Acute risk. 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 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 RfD 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.
    ii. 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 cRfD. 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 RfD 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.
    2. Infants and children--i. Safety factor for infants and children. 
The FQPA safety factor (as required by the Food Quality Protection Act 
of August 3, 1996) 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 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 (JMPR) 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.

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              Country                         Crop                                MRL (ppm)
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Argentina                            Soybean                                                               0.015
                                     Sunflower.............                                                 0.02
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Brazil                               Soybean                                                                0.05
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France                               Grape                                                                  0.05
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Paraguay                             Soybean                                                               0.015
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South Africa                         Soybean                                                                0.02
                                     Groundnut.............                                                 0.02
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Spain                                Soybean                                                                0.05
                                     Peanut................                                                 0.05
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[FR Doc. 04-26819 Filed 12-7-04; 8:45 am]
BILLING CODE 6560-50-S