[Federal Register Volume 69, Number 159 (Wednesday, August 18, 2004)]
[Notices]
[Pages 51298-51301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18769]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0137; FRL-7361-1]


Methoxyfenozide; Notice of Filing Pesticide Petitions to 
Establish Tolerances for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2004-0137, must be 
received on or before September 17, 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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; 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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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 ID number OPP-2004-0137. 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 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

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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-2004-0137. 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-2004-0137. 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-2004-0137.
    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-2004-0137. 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: August 6, 2004.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

     The petitioner's summary of the pesticide petitions is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by Interregional Research Number 4 (IR-4) 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 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

[[Page 51300]]

measurement of the pesticide chemical residues or an explanation of why 
no such method is needed.

 Interregional Research Number 4 (IR-4)

 PP 3E6768, PP 3E6784, PP 3E6790, PP 3E6796, and PP 3E6801

     EPA has received pesticide petitions (PP 3E6768, PP 3E6784, PP 
3E6790, PP 3E6796, and PP 3E6801) from IR-4, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390 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 180.544, by establishing tolerances for 
residues of the insecticide methoxyfenozide, benzoic acid, 3-methoxy-2-
methyl, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide in or 
on the following raw agricultural commodities:
    1. PP 3E6768 proposes the establishment of tolerances for 
spearmint, tops at 7.0 parts per million (ppm); peppermint, tops at 7.0 
ppm; and dill at 7.0 ppm.
    2. PP 3E6784 proposes the establishment of a tolerance for 
strawberry at 1.5 ppm.
    3. PP 3E6790 proposes the establishment of tolerances for 
vegetable, root, subgroup 1A at 0.5 ppm, and vegetable, leaves of root 
and tuber, Group 2 at 30 ppm.
    4. PP 3E6796 proposes the establishment of tolerances for papaya; 
star apple; sapote, black; mango; sapodilla; canistel; and sapote, 
mamey at 0.5 ppm. PP 3E6796 also proposes the establishment of a 
tolerance for coriander, leaves at 30 ppm.
    5. PP 3E6801 proposes the establishment of tolerances for 
vegetable, legume, edible podded, subgroup 6A at 1.5 ppm; pea and bean, 
succulent shelled, subgroup 6B at 0.2 ppm; and vegetable, foliage of 
legume, except soybean, subgroup 7A at 35 ppm.
    EPA has determined that the petitions contain data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions. This notice includes summary of the petition prepared by the 
registrant, Dow AgroScience, 9330 Zionsville Road, Indianapolis, IN 
46268.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of methoxyfenozide 
residues in plants and animals is adequately understood and was 
previously published in the Federal Register of July 5, 2000 (65 FR 
41355) (FRL-6497-5).
    2. Analytical method. Adequate enforcement methods are available 
for determination of methoxyfenozide residues in plant commodities. The 
available Analytical Enforcement Methodology was previously reviewed in 
the Federal Register of September 20, 2002 (67 FR 59193) (FRL-7198-5).
    3. Magnitude of residues. Residue data for methoxyfenozide on 
commodities listed within this notice has been submitted.

B. Toxicological Profile.

    The toxicological profile and endpoints for methoxyfenozide which 
supports this petition to establish tolerances were previously 
published in the Federal Register of September 20, 2002 (67 FR 59193).

C. Aggregate Exposure

    1. Dietary exposure. Assessments were conducted to evaluate 
potential risks due to chronic and acute dietary exposure of the U.S. 
population subgroups to residues of methoxyfenozide. These analysis 
cover all registered crops, as well as, uses pending with the Agency, 
active and proposed section 18 uses, and proposed IR-4 minor uses. 
There are no registered residential nonfat uses of methoxyfenozide.
    i. Food--a. Acute. No appropriate toxicological endpoint 
attributable to a single exposure was identified in the available 
toxicology studies on methoxyfenozide including the acute neurotoxicity 
study in rats, the developmental toxicity study in rats and the 
developmental toxicity study in rabbits. Since no acute toxicological 
endpoints were established, Dow AgroSciences considers acute aggregate 
risk to be negligible.
    b. Chronic. Chronic assessments were conducted to evaluate 
potential risks due to chronic dietary exposure of the U.S. population 
and selected population subgroups to residues of methoxyfenozide. Dow 
AgroSciences used the Dietary Exposure Evaluation Model 
(DEEMTM, Novigen Sciences, Washington, DC) software for 
conducting a chronic dietary (food) risk analysis. Dow AgroSciences 
assumed 100% of crops would be treated and contain methoxyfenozide 
residues at the tolerance level.
    ii. Drinking water--a. Acute exposure. Because no acute dietary 
endpoint was determined, Dow AgroSciences concludes that there is a 
reasonable certainty of no harm from acute exposure from drinking 
water.
    b. Chronic exposure. Tier II screening-level assessments can be 
conducted using the simulation models screening concentration in 
Groundwater (SCI-GROW) and Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) to generate estimated environmental 
concentrations (EECs) for ground water and surface water, respectively. 
The modeling was conducted based on the environmental profile and the 
maximum seasonal application rate proposed for methoxyfenozide (1.0 lb 
a.i./acre/season). PRZM/EXAMS was used to generate the surface water 
EECs because it can factor the persistent nature of the chemical into 
the estimates.
    2. Non-dietary exposure. Methoxyfenozide is not currently 
registered for use on any residential non-food sites. Therefore, there 
is no non-dietary acute, chronic, short-term or intermediate-term 
exposure.

D. Cumulative Effects

     Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' EPA does not have, at this time, 
available data to determine whether methoxyfenozide has a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, methoxyfenozide does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, it is assumed that methoxyfenozide does 
not have a common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the DEEMTM exposure 
assumptions, Dow AgroSciences has concluded that aggregate exposure to 
methoxyfenozide from the proposed new tolerances will utilize 22.2% of 
the chronic population adjusted dose (cPAD) for the U.S. population. 
The major identifiable subgroup with the highest aggregate exposure is 
children 1-2 years old at 50.9% of the cPAD. EPA generally has no 
concern for exposures below 100% of the cPAD because the cPAD 
represents the level at or below which daily aggregate dietary exposure 
over a

[[Page 51301]]

lifetime will not pose appreciable risks to human health.
    2. Infants and children. The toxicology data base for 
methoxyfenozide included acceptable developmental toxicity studies in 
both rats and rabbits as well as a 2-generation reproductive toxicity 
study in rats. The data provided no indication of increased sensitivity 
of rats or rabbits to in utero and/or postnatal exposure to 
methoxyfenozide. There is a complete toxicity data base for 
methoxyfenozide an exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. Based on the 
completeness of the data base and the lack of prenatal and postnatal 
toxicity, EPA determined that an additional safety factor was not 
needed for the protection of infants and children.
     Since no toxicological endpoints were established, acute aggregate 
risk is considered to be negligible. Using the exposure assumptions, 
Dow AgroSciences has concluded that aggregate exposure to 
methoxyfenozide from the proposed new tolerances will utilize 50.9% of 
the cPAD for infants and children. EPA generally has no concern for 
exposures below 100% of the cPAD because the cPAD represents the level 
at or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health.
    3. Drinking water. The EECs for assessing chronic aggregate dietary 
risk used by the Agency are 3.5 parts per billion (ppb) (in ground 
water, based on SCI-GROW) and 30 ppb (in surface water, based on the 
PRZM/EXAMS, long-term mean). The back-calculated drinking water levels 
of concern (DWLOCs) for assessing chronic aggregate dietary risk range 
from 501 ppb for the most highly exposed population subgroup (children 
1-2 years old) to 2,778 ppb for the U.S. population (total).
     The SCI-GROW and PRZM/EXAMS chronic EECs are less than the 
Agency's level of comparison (the DWLOC value for each population 
subgroup) for methoxyfenozide residues in drinking water as a 
contribution to chronic aggregate exposure. Dow AgroSciences thus 
concludes with reasonable certainty that residues of methoxyfenozide in 
drinking water will not contribute significantly to the aggregate 
chronic human health risk and that the chronic aggregate exposure from 
methoxyfenozide residues in food and drinking water will not exceed the 
Agency's level of concern (100% of the cPAD) for chronic dietary 
aggregate exposure by any population subgroup. EPA generally has no 
concern for exposures below 100% of the cPAD, because it is a level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to the health and safety of any population 
subgroup. This risk assessment is considered high confidence, 
conservative, and very protective of human health.

F. International Tolerances

     There are no Codex or Canadian maximum residue levels (MRLs) 
established for residues of methoxyfenozide. Mexican MRLs are 
established for residues of methoxyfenozide in cottonseed (0.05 ppm) 
and maize (0.01 ppm). The U.S. tolerances on these commodities are 2.0 
ppm and 0.05 ppm, respectively. Based on the current use patterns, the 
U.S. tolerance levels cannot be reduced to harmonize with the Mexican 
MRLs, so incompatibility will exist.

[FR Doc. 04-18769 Filed 8-17-04; 8:45 am]
BILLING CODE 6560-50-S