[Federal Register Volume 68, Number 58 (Wednesday, March 26, 2003)]
[Notices]
[Pages 14622-14626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7056]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0106; FRL-7299-3]


Azoxystrobin; Notice of Filing a Pesticide Petition to Establish 
a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket ID number OPP-2003-0106, must be 
received on or before April 25, 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.

[[Page 14623]]

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-2003-0106. 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 electonic 
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-2003-0106. 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-2003-0106. 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-2003-0106.

[[Page 14624]]

    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-2003-0106. 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: March 18, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The 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 (IR-4)

PP 2E6375, 2E6488, 2E6489, and 2E6495

    EPA has received pesticide petitions (2E6375, 2E6488, 2E6489, and 
2E6495) from the Interregional Research Project Number (IR-4), 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902 proposing, pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 
180.507 by establishing tolerances for residues of azoxystrobin, 
methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate and the Z-isomer of azoxystrobin, methyl(Z)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3 methoxyacrylate in or on the 
following raw agricultural commodities: asparagus at 0.02 parts per 
million (ppm) (2E6375); brassica, head and stem, subgroup 5a at 3.0 ppm 
(2E6488); artichoke, globe at 4.0 ppm (2E6489); herb subgroup 19A, 
fresh, except chive at 50 ppm (2E6495); and herb subgroup 19A, dried, 
except chive at 260 ppm (2E6495). 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 these petitions. This summary has been prepared by 
Syngenta, the registrant.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of azoxystrobin as well as the 
nature of the residues is adequately understood for purposes of the 
tolerances.
    2. Analytical method. An adequate analytical method, gas 
chromatography with nitrogen-phosphorus detection (GC-NPD) or in mobile 
phase by high performance liquid chromatography with ultra-violet 
detection (HPLC-UV), is available for enforcement purposes with a limit 
of detection that allows monitoring of food with residues at or above 
the levels set in these tolerances. The Analytical Chemistry section of 
the EPA concluded that the method(s) are adequate for enforcement. 
Analytical methods are also available for analyzing meat, milk, poultry 
and eggs which also underwent successful independent laboratory 
validations.
    3. Magnitude of residues. Complete residue data for azoxystrobin on 
artichoke, globe; asparagus, head and stem brassica and herb subgroup 
19A have been submitted. The requested tolerances are adequately 
supported.

B. Toxicological Profile

[[Page 14625]]



     Table 1.--Summary of Toxicological Dose and Endpoints for Azoxystrobin for Use in Human Risk Assessment
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                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
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Acute dietary (general population      NOAEL=<200 mg/kg/day     FQPA SF = 1X             Acute neurotoxicity
 including infants and children)       UF=300.................  aPAD = Acute RfD + FQPA   study in rates
                                       Acute RfD=0.67 mg/kg/     SF = 0.67 mg/kg/day.    LOAEL = 200 mg/kg/day
                                        day.                                              based on diarrhea and
                                                                                          2 hours post dose at
                                                                                          all dose levels up to
                                                                                          and including 20 mg/kg/
                                                                                          day (the LOAEL)
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Chronic dietary (all populations)      NOAEL = 18 mg/kg/day     FQPA SF = 1X             Combined chronic
                                       UF=100.................  cPAD = chronic RfD +      toxicity
                                       Chronic RfD = 0.18 mg/    FQPA SF = 0.18 mg/kg/    carcinogenicity
                                        kg/day.                  day.                     feeding study in rates
                                                                                         LOAEL = 34/117 mg/kg/
                                                                                          day in males/females
                                                                                          based on reduced body
                                                                                          weights in both sexes
                                                                                          and bile duct lesions
                                                                                          in males.
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Short-term (1-7 days) incidental oral  NOAEL = 25 mg/kg/day     FQPA SF = 1X             Prenatal developmental
 (residential)                         UF = 100...............                            oral toxicity study in
                                                                                          rates
                                                                                         LOAEL = 100 mg/kg/day
                                                                                          based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation.
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Intermediate-term (1 week to several   NOAEL = 20 mg/kg/day     FQPA SF = 1X             90-Day feeding study in
 months) incidental oral               UF = 100...............                            rats
 (residential)                                                                           LOAEL = 211/223 mg/kg/
                                                                                          day in males/females
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          both sexes and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition.
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Short- intermediate-, and long-term    None                     None                     21-Day repeated dose
 dermal (residential)                                                                     dermal study in rats.
                                                                                          No dermal or systemic
                                                                                          toxicity was seen at
                                                                                          the limit does (1,000
                                                                                          mg/kg/day). This risk
                                                                                          assessment is not
                                                                                          required.
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Short-term inhalation (1-7 days)       Oral Study NOAEL = 25    LOC for MOE = 100        Prenatal developmental
 (residential)                          mg/kg/day (inhalation    (residential)            oral toxicity study in
                                        absorption rate -                                 rats.
                                        100%)                                            LOAEL = 100 mg/kg/day
                                                                                          based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence
                                                                                          and salivation.
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Intermediate-term inhalation (1 week   Oral Study NOAEL = 20    LOC for MOE = 100        90-Day feeding study in
 to several months) (residential)       mg/kg/day (inhalation    (residential)            rats
                                        absorption rate -                                LOAEL = 211/223 mg/kg/
                                        100%)                                             day in males/females
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          both sexes and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition.
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Long-term inhalation (>180 days)       None                     None                     This risk assessment is
 (residential)                                                                            not applicable to the
                                                                                          use of azoxystrobin
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Cancer (oral, dermal, inhalation)      None                     None                     Azoxystrobin is
                                                                                          classified as not
                                                                                          likely to be
                                                                                          carcinogenic in humans
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    2. Metabolite toxicology. There are no metabolites of concern based 
on a differential metabolism between plants and animals.
    3. Endocrine disruption. There is no evidence that azoxystrobin is 
an endocrine disrupter.

C. Aggregate Exposure

    1. Dietary exposure. Tolerance values have been established (40 CFR 
180.507(a)) for the combined residues of both azoxystrobin and its Z 
isomer, in or on a variety of raw agricultural commodities including 
meat, milk and eggs. These established tolerances range from 0.02 ppm 
on tree nuts to 55 ppm on soybean hay.
    i. Food. Tier I acute and chronic dietary exposure evaluations were 
made using the Dietary Exposure Evaluation Model (DEEM[reg]), version 
7.76 from Exponent. All processing factors used DEEM[reg] defaults 
values. All consumption data for these assessments were taken from the 
USDA's Continuing Survey of Food Intake by individuals (CSFII) with the 
1994-1996 consumption data base and the Supplemental CSFII children's 
survey (1998) consumption data base. These dietary exposure assessments 
included all registered uses and proposed uses on asparagus (0.02 ppm), 
brassica, head and stem subgroup 5A (3 ppm), herb subgroup 19A (250 
ppm) and artichoke globe (4 ppm).
    ii. Drinking water. There is no established maximum concentration 
level (MCL) for residues of azoxystrobin in drinking water. No health 
advisory levels for azoxystrobin in drinking water have been 
established. The concentration of azoxystrobin in surface water is 
based on generic estimated environmental concentration (GENEEC) 
modeling and in ground water based on screening concentration in ground 
water (SCI-GROW) modeling.
    2. Non-dietary exposure. Azoxystrobin is registered for residential 
use on ornamentals and turf. The Agency evaluated the existing 
toxicological data base for azoxystrobin and assessed both the 
appropriate toxicological endpoints and the dose levels of concern. 
Dermal absorption data indicate that absorption is less than or equal 
to 4%.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish,

[[Page 14626]]

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.'' Azoxystrobin is related to the naturally 
occurring strobilurins. Syngenta concluded that further consideration 
of a common mechanism of toxicity is not appropriate at this time since 
there are no data to establish whether a common mechanism exists with 
any other substances.

E. Safety Determination

    1. Infants and Children. The chronic dietary exposure (food only) 
resulting from all established and proposed azoxystrobin uses was 27.6% 
of the reference dose (RfD) for the most sensitive subpopulation, 
children 1 and 2 years old. Additionally, for this same subpopulation, 
the acute dietary exposure (food only) resulting from all established 
and proposed azoxystrobin uses was 22.3% of the acute reference dose 
(aRfD). The EPA has determined that there is reliable data support 
using the standard MOE and uncertainty factor (100X for chronic and 
300X for acute) for azoxystrobin and that an additional safety factor 
of 10 is not necessary to be protective of infants and children.
    Syngenta has considered the potential aggregate exposure from food, 
water and non-occupational exposure routes and concludes that aggregate 
exposure is not expected to exceed 100% of the chronic reference dose 
and that there is a reasonable certainty that no harm will result to 
infants and children from the aggregate exposure to azoxystrobin.

[FR Doc. 03-7056 Filed 3-25-03; 8:45 am]
BILLING CODE 6560-50-S