FLUORIDE ACTION NETWORK PESTICIDE
PROJECT
Return to FAN's Pesticide Homepage
Return to Indoxacarb Index Page
Indoxacarb and its R-enantiomer
(DUPONT and IR-4).
May 5, 2004. Pesticide petition. Federal Register.
Note from FAN: This petition requests increasing the tolerance of 5 ppm to 12 ppm for the vegetable Brassica, leafy, group 5; and for turnip at 12 ppm.
broccoli
broccoli raab
broccoli, chinese
brussels sprouts
cabbage
cabbage, chinese, bok choy
cabbage, chinese, mustard
cabbage, chinese, napa
cauliflower
collards
kale
kohlrabi
mustard greens
mustard spinach
rape greenshttp://www.epa.gov/fedrgstr/EPA-PEST/2004/May/Day-05/p9723.htm
[Federal Register: May 5, 2004 (Volume 69, Number 87)]
[Notices]
[Page 25104-25107]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my04-70]
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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:
brothers.shaja@epa.gov.
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
[[Page 25105]]
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 toopp-docket@epa.gov,
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
[[Page 25107]]
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