[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Notices]
[Pages 13917-13920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6821]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0086; FRL-7297-1]


Methoxyfenozide; Notice of Filing Pesticide Petitions 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-2003-0086, must be 
received on or before April 21, 2003.

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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-2003-0086. 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

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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 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-2003-0086. 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-2003-0086. 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-2003-0086.
    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-2003-0086. 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

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included in the public docket and EPA's electronic public docket 
without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: March 13, 2003.
Debra Edwards,
 Acting Director, Registration Division, Office of Pesticide Programs.

 Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

 Interregional Research Project Number 4 (IR-4)

 PP 3E6527, 3E6528, and 3E6533

    EPA has received pesticide petitions 3E6527, 3E6528, and 3E6533 
from the Interregional Research Project Number 4 (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 part 180 by establishing tolerances for residues of methoxyfenozide 
in or on the raw agricultural commodities (RAC): Vegetable, cucurbit, 
group 9 at 0.3 parts per million (ppm) (3E6527), pea, blackeyed, seed 
and pea, southern, seed at 4.0 ppm (3E6528), okra at 2.0 ppm (3E6533), 
and turnip, greens at 30 ppm (3E6533). 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 a 
summary of the petitions prepared by Rohm and Haas Company, 100 
Independence Mall West, Philadelphia, PA 19106-2399.

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).
    3. Magnitude of residues. Complete residue data for methoxyfenozide 
on okra; turnip greens; cucurbit vegetables; pea, blackeyed; and pea, 
southern have 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) 
(FRL-7198-5).

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 nonfood uses of methoxyfenozide.
    i. Food--a. Acute exposure. 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 exposure. Dow AgroSciences assumed 100% of crops would 
be treated and contain methoxyfenozide residues at the tolerance level. 
Dow AgroSciences used the Dietary Exposure Evaluation Model 
(DEEMTM, Novigen Sciences, Washington, DC) software for 
conducting a chronic dietary (food) risk analysis. DEEMTM 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. DEEMTM contains 
food consumption data as reported by respondents in the Department of 
Agriculture (USDA) continuing surveys of food intake by individuals 
conducted in 1994-1996.
    ii. Drinking water--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.
    ii. Chronic exposure. Tier II screening-level assessments can be 
conducted suing the simulation models screening constration in ground 
water (SCI-GROW) and EPA's pesticide root zone model/exposure analysis 
modeling system (PRZM/EXAMS) to generate estimated environmental 
concentrations (EECs) for ground water and surface

[[Page 13920]]

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/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 the 
Agency are 6 parts per billion (ppb) in ground water, based on SCI-GROW 
and 98.5 ppb in surface water, based on the PRZM/EXAMS, long-term mean.
    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 described in this unit, Dow AgroSciences has concluded that 
aggregate exposure to methoxyfenozide from the proposed new tolerances 
will utilize 18.9% of the chronic pollution adjusted dose (cPAD) for 
the U.S. population. The major identifiable subgroup with the highest 
aggregate exposure is children 1-6 years old at 37.6% of the cPAD and 
is discussed below. 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, the aggregate exposure is not 
expected to exceed 100% of the cPAD. Dow AgroSciences concludes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to methoxyfenozide residues.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold 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 inter-species and intra-species variability and not the 
additional tenfold 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 37.6% 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.
    Drinking water. The back-calculated drinking water levels of 
concern (DWLOCs) for assessing chronic aggregate dietary risk range 
from 624 ppb for the most highly exposed population subgroup children 
(1 to 6) years old to 2,839 ppb for the U.S. population (48 contiguous 
States) (all seasons). 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-term 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 (MRL's) 
established for residues of methoxyfenozide. Mexican MRL's 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 MRL's, 
so incompatibility will exist.
[FR Doc. 03-6821 Filed 3-20-03; 8:45 am]
BILLING CODE 6560-50-S