[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18004-18008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6852]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0089; FRL-7706-8]


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 a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0089, must be received on or before May 9, 2005.

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:  Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
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 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 32532)
     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

[[Page 18005]]

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 ID number OPP-2005-0089. 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, 1801 S. Bell St., 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 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-2005-0089. 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-2005-0089. 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),

[[Page 18006]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2005-0089.
    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-2005-0089. 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 22, 2005.
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 Interregional Research Project Number 4 (IR-
4), 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.

 Interregional Research Project Number 4 (IR-4)

 PP 4E6845

     EPA has received a pesticide petition (4E6845) from Interregional 
Research Project Number 4 (IR-4), Rutgers, State University of New 
Jersey, 681 U.S. Highway No. 1 S. North New Brunswick, NJ 08902, 
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 strawberry at 0.10 parts per million (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 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/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.
    3. Magnitude of residues. Residue data on strawberry have been 
submitted which adequately support the requested tolerance.

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).

C. Aggregate Exposure

    1. Dietary exposure. Acute and chronic dietary analyses were 
conducted to estimate exposure to potential flumioxazin residues in/on 
the following crops: Peanuts, soybeans, and cottonseed oil (existing 
tolerances); grapes, almond, pistachio, and sugarcane, vegetable, 
tuberous and corm (Subgroup 1C), mint, and fruit, pome (Group 11) and 
fruit, stone (Group 12) (tolerances pending); asparagus, vegetable, 
bulb (Group 3), leaf petioles (Subgroup 4B), dried shelled peas and 
beans Subgroup 6C), vegetables, fruiting (Group 8), vegetables, 
cucurbit (Group 9), berries (Group 13), and nut, tree (Group 
14)(tolerances to be proposed in the future); and strawberry 
(tolerances proposed in the current petition). The Cumulative and 
Aggregate Risk Evaluation System (CARES) Version 2.0 was used to 
conduct these assessments. These Tier I assessments used issued and 
proposed tolerances, default processing factors, and the assumption

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of 100% crop treated. No adjustments were made for common washing, 
cooking or preparation practices. Exposure estimates for water were 
made based upon modeling (GENEEC 1.2).
    i. Food--a. Acute. The acute dietary exposure estimate of 
flumioxazin residues in food at the 99.9th percentile for 
females 13-49 years old was calculated to be, at most, 21.9% of the 
acute population adjusted dose (a-PAD) with a margin of exposure (MOE) 
of 450. This is the only population subgroup with an identified acute 
toxicity endpoint. The a-PAD was defined as the NOEL from an oral 
developmental study in rats and includes an uncertainty factor of 100 
to account for intra-species and inter-species variation (NOEL = 3 
milligrams/kilogram body weight/day (mg/kg bwt/day), a-PAD = 0.03 mg/
kg/day).
    b. Chronic dietary exposure. The chronic dietary exposure estimate 
of flumioxazin residues in food at the 100th percentile was 
calculated to be, at most, 18.1% of the chronic population adjusted 
dose (c-PAD) with a MOE of 550. The population subgroup with the 
highest exposure was children 3-5 years old. The c-PAD was defined as 
the no observed effect level (NOEL) from a rat 2-year chronic/
oncogenicity study and includes an uncertainty factor of 100 to account 
for intra-species inter-species variation (NOEL = 2 mg/kg bwt/day, c-
PAD = 0.02 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 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 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; 0.17% of the 
c-PAD of 0.02 mg/kg/day for children. Based on this worse case 
analysis, the contribution of drinking water is 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 females 13-49 years old will utilize at most 21.9% of the 
a-PAD. This is the only population subgroup with an identified acute 
toxicity endpoint. Addition of the worse case, dietary exposure from 
water (0.00028 mg/kg/day) increases this exposure at the 
99.9th percentile to 22.8% of the a-PAD. The Agency has no 
cause for concern if total acute residue contribution is less than 100% 
of the a-PAD, because the PAD 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 8.0% of the c-PAD. Addition of the worse case, dietary 
exposure from water (0.0000097 mg/kg/day) has no effect on this 
exposure. The Agency has no cause for concern if total chronic residue 
contribution is less than 100% of the c-PAD, because the PAD 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. 
EPA has determined that the special 10x SF to protect infants and 
children should be removed as published in the Federal Register of 
March 31, 2004 (69 FR 16823) (FRL-7351-2). The FQPA factor has been 
removed because developmental toxicity and offspring toxicity no 
observed adverse effect levels/lowest adverse effect levels (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 to 
this subgroup is required.
    iii. Chronic risk. The potential chronic exposure from food to 
children 3-5 years old (the most highly exposed child/infant subgroup) 
will utilize at most 18.1% of the c-PAD. Addition of the worse case, 
dietary exposure from water (0.000034 mg/kg/day) increases this 
exposure at the 100th percentile to 18.3% of the c-PAD. 
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 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 Sunflower                                             0.015 0.02
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Paraguay                                Soybean                                                            0.015
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South Africa                            Soybean Groundnut                                              0.02 0.02
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Spain                                   Soybean Peanut                                                 0.05 0.05
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[FR Doc. 05-6852 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S