[Federal Register Volume 69, Number 156 (Friday, August 13, 2004)]
[Notices]
[Pages 50192-50196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18576]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0184; FRL-7364-9]


Methoxyfenozide; 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-
2004-0184, must be received on or before September 13, 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: Joseph Tavano, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6411; 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 a 
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 ID number OPP-2004-0184. 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 EPA's 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

[[Page 50193]]

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.1. 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 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-2004-0184. 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-2004-0184. 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-2004-0184.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0184. 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.

[[Page 50194]]

    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 pesticide 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 
pesticide petition. Additional data may be needed before EPA rules on 
the pesticide petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 2, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition (PP) 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 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.

Dow AgroSciences

PP 3F6794

    EPA has received a pesticide petition 3F6794 from Dow AgroSciences, 
9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to 
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 
180 by establishing a tolerance for residues of methoxyfenozide in or 
on the raw agricultural commodity soybean, seed at 2 parts per million 
(ppm), soybean, forage at 45 ppm, soybean, hay at 65 ppm, soybean, 
aspirated grain fractions at 200 ppm, soybean, hulls at 3 ppm, soybean, 
meal at 0.1 ppm, soybean, oil at 1.0 ppm. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The 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. Complete residue data for methoxyfenozide 
on soybeans has been submitted. The requested tolerances are adequately 
supported.

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 analyses 
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 nonfood uses of methoxyfenozide.
    i. Food--a. Acute risk. 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. 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. These analyses 
cover all registered crops, uses pending with the EPA, active and 
proposed section 18 uses and new proposed IR-4 uses. Dow AgroSciences 
used the Dietary Exposure Evaluation Model (DEEM), Novigen Sciences, 
Washington, DC software for conducting a chronic dietary (food) risk 
analysis. DEEM is a dietary exposure analysis system that is used to 
estimate exposure to a pesticide chemical in foods comprising the diets 
of the U.S. population, including population subgroups. DEEM contains 
food consumption data as reported by respondents in the United States 
Department of Agriculture (USDA) Continuing Surveys of Food Intake by 
Individuals conducted in 1994 to 1998. Dow AgroSciences assumed 100% of 
crops would be treated and contain methoxyfenozide residues at the 
tolerance level. The resulting dietary exposure analysis is summarized 
in Table 1.
    The resulting dietary food exposures occupy up to 49.4% of the 
chronic population adjusted dose (PAD) for the most highly exposed 
population subgroup, children 1 to 2 years old. These results should be 
viewed as conservative (health protective) risk estimates. Refinements 
such as use of percent crop-treated information and/or anticipated 
residue values would yield even lower estimates of chronic dietary 
exposure.

      Table 1.--Chronic Dietary Exposure Analysis by DEEM (Tier 1)
------------------------------------------------------------------------
                                       Exposure
                                      milligrams/     Percent of chronic
       Population Subgroup         kilogram/day (mg/          PAD
                                        kg/day)
------------------------------------------------------------------------
U.S. population - (total)         0.022050            21.6
------------------------------------------------------------------------
All infants (<1-year)             0.025136            24.6
------------------------------------------------------------------------
Nursing infants                   0.012513            12.3
------------------------------------------------------------------------
Non-nursing infants               0.029929            29.3
------------------------------------------------------------------------

[[Page 50195]]

 
Children (1 to 6 years old)       0.042473            41.6
------------------------------------------------------------------------
Children (1 to 2 years old)       0.050351            49.4
------------------------------------------------------------------------
Children (7 to 12 years old)      0.024944            24.5
------------------------------------------------------------------------
Females 13+ (nursing)             0.021631            21.2
------------------------------------------------------------------------
Non-Hispanic/non-white/non-black  0.030599            30.0
------------------------------------------------------------------------

    Percent chronic PAD - (exposure divided by chronic PAD x 100%). The 
subgroups listed are:
     The U.S. population (total).
     Those for infants and children.
     The most highly exposed of the females sub-groups, in this 
case females 13+ (nursing).
     The most highly exposed of the remaining subgroups, in 
this case non-hispanic/non-white/non-black.
    ii. Drinking water. There are no water-related exposure data from 
monitoring to complete a quantitative drinking water exposure analysis 
and risk assessment for methoxyfenozide. Generic Expected Environmental 
Concentration (GENEEC) and/or EPA's Pesticide Root Zone Model/Exposure 
Analysis Modeling System (PRZM/EXAMS) (both produce estimates of 
pesticide concentration in a farm pond) are used to generate estimated 
environmental concentrations (EECs) for surface water and Screening 
Concentration in Ground Water (SCI-GROW) (an empirical model based upon 
actual monitoring data collected for a number of pesticides that serve 
as benchmarks) predicts EECs in ground water. These models take into 
account the use patterns and the environmental profile of a pesticide, 
but do not include consideration of the impact that processing raw 
water for distribution as drinking water would likely have on the 
removal of pesticides from the source water. The primary use of these 
models at this stage is to provide a coarse screen for assessing 
whether a pesticide is likely to be present in drinking water at 
concentrations which would exceed human health levels of concern.
    A drinking water level of comparison (DWLOC) is the concentration 
of a pesticide in drinking water that would be acceptable as a 
theoretical upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. EPA's Health Effects 
Division (HED) uses DWLOCs internally in the risk assessment process as 
a surrogate measure of potential exposure associated with pesticide 
exposure through drinking water. In the absence of monitoring data for 
a pesticide, the DWLOC is used as a point of comparison against the 
conservative EECs provided by computer modeling (SCI-GROW, GENEEC, 
PRZM/EXAMS).
    a. Acute exposure and risk. 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 and risk. Tier II screening-level assessments 
can be conducted using the simulation models SCI-GROW and PRZM/EXAMS to 
generate 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 
active ingredient (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.
    The EECs for assessing chronic aggregate dietary risk used by HED 
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 DWLOCs for assessing chronic aggregate dietary risk 
range from 516 ppb for the most highly exposed population subgroup 
(children 1 to 2 years old) to 2,798 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 chronic PAD) for chronic dietary aggregate exposure by any 
population subgroup. EPA generally has no concern for exposures below 
100% of the chronic PAD, 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.

                                                 Table 2.--DWLOC for Chronic Exposure to Methoxyfenozide
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Dietary Exposure\a\    DWLOC\b\ gram/Liter   Surface water ([mu]g/   Ground water ([mu]g/
          Population Group            cPAD (mg/kg bwt/day)       (mg/kg bwt/day)           ([mu]g/L)                  L)                     L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (total)              0.102                   0.022050                2798                   30                     3.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1-year old)            0.102                   0.025136                769                    30                     3.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2years old)              0.102                   0.050351                516                    30                     3.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49years old)             0.102                   0.019634                2471                   30                     3.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ From DEEM Analysis
\b\ DWLOC = (cPAD - dietary exposure) x body weight/drinking water consumption


[[Page 50196]]

    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 DEEM exposure assumptions described 
in this unit, Dow AgroSciences has concluded that aggregate exposure to 
methoxyfenozide from the proposed new tolerances will utilize 21.6% of 
the chronic PAD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is children 1 to 2 years 
old at 49.4% of the chronic PAD and is discussed below. EPA generally 
has no concern for exposures below 100% of the chronic PAD because the 
chronic PAD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. Despite the potential for exposure to methoxyfenozide in 
drinking water, the aggregate exposure is not expected to exceed 100% 
of the chronic PAD. Dow AgroSciences concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to methoxyfenozide residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of methoxyfenozide, EPA 
considered data from developmental toxicity studies in the rat and 
rabbit and a 2-generation reproduction study in the rat. The 
developmental toxicity studies are designed to evaluate adverse effects 
on the developing organism resulting from maternal pesticide exposure 
during gestation. Reproduction studies provide information relating to 
effects from exposure to the pesticide on the reproductive capability 
of mating animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional ten-
fold margin of safety for infants and children in the case of threshold 
effects to account for prenatal and postnatal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard uncertainty factor (UF) (usually 100 for combine 
interspecies and intraspecies variability) and not the additional ten-
fold MOE/UF when EPA has a complete data base under existing guidelines 
and when the severity of the effect in infants or children or the 
potency or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard MOE/safety factor.
    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 and 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 
described in this unit, Dow AgroSciences has concluded that aggregate 
exposure to methoxyfenozide from the proposed new tolerances will 
utilize 49.4% 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. 
Despite the potential for exposure to methoxyfenozide in drinking 
water, Dow AgroSciences does not expect the aggregate exposure to 
exceed 100% of the cPAD. Short and intermediate term risks are judged 
to be negligible due to the lack of significant toxicological effects 
observed. Based on these risk assessments, Dow AgroSciences concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to methoxyfenozide 
residues.

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. 04-18576 Filed 8-12-04; 8:45 am]
BILLING CODE 6560-50-S