[Federal Register: March 21, 2003 (Volume 68, Number 55)]
[Notices]
[Page 13917-13920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr03-61]
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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:
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:
[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
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 opp-docket@epa.gov,
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
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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