[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Notices]
[Pages 25104-25107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9723]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0064; FRL-7354-9]


Indoxacarb; 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 ID number OPP-2004-0064, must be 
received on or before June 4, 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: 
[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 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 
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-2004-0064. 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

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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-2004-0064. 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-2004-0064. 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-2004-0064.
    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-2004-0064. 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: April 15, 2004.
Betty Shackleford,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
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 material, or the summary

[[Page 25106]]

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 Number 4 (IR-4)

PP 2E6482

    EPA has received a pesticide petition 2E6482 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 180.564(a) by revoking Brassica, head and stem, subgroup at 5.0 
parts per million (ppm), and establishing tolerances for residues of 
the insecticide, indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-
(methoxycarbonyl)([4-trifluoromethoxy)phenyl amino carbonyl indeno 1,2e 
1,3,4 oxadiazine-4a3H)- carboxylate] and its R-enantiomer [R-methyl 7-
chloro-2,5-dihydro-2-methoxycarbonyl)[4-trifluoromethoxy) phenyl] amino 
carbonyl indeno 1,2-e 1,3,4 oxadiazine-4a3H)-carboxylate] in or on the 
raw agricultural commodities (RACs) vegetable, Brassica, leafy, group 5 
at 12 ppm, and turnip at 12 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. This notice includes a summary of the 
petition prepared by du Pont de Nemours and Company, Crop Protection, 
Wilmington, DE, 19898.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of indoxacarb in plants is 
adequately understood to support these tolerances. Plant metabolism 
studies in cotton, lettuce, grapes and tomatoes showed no significant 
metabolites. The only significant residue was parent compound.
    2. Analytical method. The plant residue enforcement method detects 
and quantitates indoxacarb in various matrices including lettuce, 
tomato, pepper, cabbage, broccoli, cauliflower, apple, pear, grape, 
cottonseed, tomato, mustard greens, and apple processed commodity 
samples by gas chromatography mass spectrometry detection (GC-MSD). The 
limit of quantitation (LOQ) of the method allows monitoring of crops 
with indoxacarb residues at or above the levels proposed in these 
tolerances.
    3. Magnitude of residues. The residue study for mustard greens is 
as follows: Residue studies were conducted at a total of five field 
sites. All studies were done using Avaunt Insecticide containing 30% 
active ingredient 300 g DPX KN128 per kg, (w/w). Four broadcast 
applications of Avaunt Insecticide were made at each test site at a 
maximum rate of 0.067 lb a.i. DPX-KN128/acre/application maximum 
seasonal use rate of 0.267 lb DPX-KN128/(acre). Applications were made 
approximately 3 days apart. Residues were measured as the combination 
of DPX-KN128 and IN-KN127 enantiomers not resolved by the analytical 
method. Maximum residues of KN128/KN127 in individual duplicate samples 
were 9.8 ppm at a PHI of 3 days range 1.2, 9.8 ppm. Residues for head 
and stem Brassica are already established based on previously submitted 
data for cabbage, broccoli, and cauliflower.

B. Toxicological Profile.

    An assessment of the toxic effects caused by indoxacarb is 
discussed in Unit III.A. and Unit III.B. of the Federal Register dated 
July 2, 2003 (68 FR 737765) (FRL-7310-7).

C. Aggregate Exposure

    1. Dietary exposure. Chronic dietary exposure resulting from the 
currently approved use of indoxacarb on apples, broccoli, cabbage, 
cauliflower, cotton, cranberry (current section 18 use), peach (current 
EUP use), pears, peppers, sweet corn, tomatoes, alfalfa, lettuce, 
peanuts, potatoes, soybeans, and the proposed uses on grapes, cherries 
(proposed EUP use), crop group 5 - Brassica (cole) leafty vegetables 
group, and turnip, tops (greens) are well within acceptable limits for 
all population subgroups. Tolerances for indoxacarb are pending to 
support agricultural use on grapes, and temporary tolerances for 
indoxacarb are pending to support agricultural use on cherries. 
Tolerances are also proposed to support agricultural uses for crop 
group 5, Brassica (cole) leafy vegetables group, and turnip, tops 
(greens). The established tolerance 5 ppm for Brassica, head and stem, 
subgroup 5A is being revoked.
    i. Food--Chronic dietary exposure assessment. The Chronic Module of 
the Dietary Exposure Evaluation Model ((DEEM), Exponent, Inc. formerly 
Novigen Sciences, Inc., 1997 Version 7.72) was used to conduct the 
assessment with the reference dose (RfD) of 0.02 milligrams/kilogram/
day (mg/kg/day). The analysis used overall mean field trial values, 
processing factors, and projected peak percent crop treated (PCT) 
values. Secondary residues in milk, meat, and poultry products were 
also included in the analysis. The chronic dietary exposure to 
indoxacarb is 0.000089 mg/kg/day, and utilizes 0.4% of the RfD for the 
overall U.S. population. The exposure of the most highly exposed 
subgroup in the population, children age 1-6 years, is 0.000238 mg/kg/
day, and utilizes 1.2% of the RfD.
    2. Acute dietary exposure. The Tier 3 analysis used distributions 
of field trial residue data adjusted for projected peak PCT. Secondary 
residues in milk, meat and poultry products were also included in the 
analysis.
    ii. Drinking water. Indoxacarb is highly unlikely to contaminate 
ground water resources due to its immobility in soil, low water 
solubility, high soil sorption, and moderate soil half-life. Based on 
the EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System 
(PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-GROW) 
models the estimated environmental concentrations (EECs) of indoxacarb 
and its R-enantiomer for acute exposures are estimated to be 6.84 parts 
per billion (ppb) for surface water and 0.0025 ppb for ground water. 
The EECs for chronic exposures are estimated to be 0.316 ppb for 
surface water and 0.0025 ppb for ground water.
    2. Non-dietary exposure. Indoxacarb products are not labeled for 
residential non-food uses, thereby eliminating the potential for 
residential exposure. Non-occupational, non-dietary exposure for DPX-
MP062 has not been estimated because the proposed products are limited 
to commercial crop production. Therefore, the potential for non-
occupational exposure is insignificant.

D. Cumulative Effects

    EPA's consideration of a common mechanism of toxicity is not 
necessary at this time because there is no indication that toxic 
effects of indoxacarb would be cumulative with those of any other 
chemical compounds. Oxadiazine chemistry is new, and indoxacarb has a 
novel mode of action compared to currently registered active 
ingredients.

E. Safety Determination

    1. U.S. population. Dietary and occupational exposure will be the 
major routes of exposure to the U.S. population. The chronic dietary 
exposure to indoxacarb is 0.000089 mg/kg/day, which utilizes 0.4% of 
the RfD

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for the overall U.S. population, using mean field trial values, 
processing factors, and projected peak PCT values. The percent of the 
acute population adjusted dose (aPAD) 7.3% for the overall U.S. 
population shows that an adequate margin of safety exists. Using only 
pesticide handlers exposure database (PHED) data levels A and B (those 
with a high level of confidence), the margin of exposures for 
occupational exposure are 650 for mixer/loaders and 1,351 for airblast 
applicators (worst-case). Based on the completeness and reliability of 
the toxicity data and the conservative exposure assessments, there is a 
reasonable certainty that no harm will result from the aggregate 
exposure of residues of indoxacarb including all anticipated dietary 
exposure and all other non-occupational exposures. There are 
residential uses of indoxacarb pending; however, the potential exposure 
calculation is considered extremely minimal. Drinking water levels of 
comparison (DWLOCs), theoretical upper allowable limits on the 
pesticide's concentration in drinking water, were calculated to be much 
higher than the EECs. The chronic DWLOCs ranged from 198 to 697 ppb. 
The acute DWLOCs ranged from 440 to 3,890 ppb. Thus, the estimated 
levels of indoxacarb in drinking water are well below the DWLOC.
    2. Infants and children. Chronic dietary exposure of the most 
highly exposed subgroup in the population, children age 1-6 years, is 
0.000238 mg/kg/day 1.2% of the reference dose (RfD). For infants non-
nursing, (1 year), the exposure accounts for 0.3% of the RfD. For acute 
exposure at the 99.9th percentile based on a Tier 3 
assessment, the exposure was 0.013973 mg/kg/day (11.6% aPAD) for 
children 1-6 years, and 0.026036 mg/kg/day (21.7% aPAD) for non-nursing 
infants. Based on the completeness and reliability of the toxicity 
data, the lack of toxicological endpoints of special concern, the lack 
of any indication that children are more sensitive than adults to 
indoxacarb, and the conservative exposure assessment, there is a 
reasonable certainty that no harm will result to infants and children 
from the aggregate exposure of residues of indoxacarb, including all 
anticipated dietary exposure, and all other non-occupational exposures. 
Accordingly, there is no need to apply an additional safety factor for 
infants and children.

F. International Tolerances

    To date, no international tolerances exist for indoxacarb.
[FR Doc. 04-9723 Filed 5-4-04; 8:45 am]
BILLING CODE 6560-50-S