[Federal Register Volume 67, Number 84 (Wednesday, May 1, 2002)]
[Notices]
[Pages 21676-21679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10633]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0029; FRL-6834-7]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket control number OPP-2002-0029, 
must be received on or before May 31, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-2002-0029 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

[[Page 21677]]



 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0029. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-2002-0029 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-2002-0029. Electronic comments 
may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record 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 
control 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 pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals 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 these petitions contain data or information 
regarding the elements set forth in 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 a additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: April 17, 2002.
  Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required

[[Page 21678]]

by section 408(d)(3) of the FFDCA. The summaries of the petitions were 
prepared by the petitioners and represent the views of the petitioners. 
EPA is publishing the petition summaries verbatim without editing them 
in any way. 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 4 (IR-4)

2E6356, 2E6372, 2E6375, and 2E6376

    EPA has received pesticide petitions numbers 2E6356, 2E6372, 
2E6375, and 2E6376, 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 180.507 by establishing and/or amending tolerances for the 
combined 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 agricultural commodities:
    1. PP# 2E6356 proposes to establish a tolerance for caneberry 
subgroup at 5.0 parts per million (ppm).
    2. PP# 2E6372 proposes to increase the existing tolerance for 
pistachio from 0.02 ppm to 1.0 ppm.
    3. PP# 2E6375 proposes to establish a tolerance for asparagus at 
0.02 ppm.
    4. PP# 2E6376 proposes to establish a tolerance for cranberry at 
0.5 ppm.
    Additional data may be needed before EPA rules on the petition. 
Syngenta Crop Protection, Inc. (Syngenta), Greenboro, North Carolina 
27409, is the manufacturer of the chemical pesticide, azoxystrobin. 
Syngenta prepared and submitted the following summary of information, 
data, and arguments in support of the pesticide petitions. This summary 
does not necessarily reflect the findings of EPA.

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 
proposed tolerances. Plant metabolism has been evaluated in four 
diverse crops, cotton, grapes, wheat, and peanuts which should serve to 
define the similar metabolism of azoxystrobin in a wide range of crops. 
Parent azoxystrobin is the major component found in crops. Azoxystrobin 
does not accumulate in crop seeds or fruits. Metabolism of azoxystrobin 
in plants is complex with more than 15 metabolites identified. These 
metabolites are present at low levels, typically much less than 5% of 
the total radioactive residue (TRR).
    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 (LOD) that allows monitoring of food with residues at or 
above the levels set in these tolerances. The analytical chemistry 
section of 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 
caneberries, cranberries, pistachios, head and stem brassica, and 
asparagus have been submitted. The requested tolerances are adequately 
supported.

B. Toxicological Profile

    An assessment of toxic effects caused by azoxystrobin is discussed 
in Unit III. A. and Unit III. B. of the Federal Register dated 
September 21, 2001 (66 FR 48585).
    1. Metabolite toxicology. There are no metabolites of concern based 
on a differential metabolism between plants and animals.
    2. Endocrine disruption. There is no evidence that azoxystrobin is 
an endocrine disrupter.

C. Aggregate Exposure

    1. Dietary exposure from food and feed uses. Permanent tolerances 
have been established (40 CFR 180.507(a)) for the combined residues of 
azoxystrobin and its Z isomer, in or on a variety of raw agricultural 
commodities at levels ranging from 0.02 ppm on tree nuts to 50 ppm on 
leaves of root and tuber vegetables. Included in these tolerances are 
the numerous ones for animal commodities which were established in 
conjunction with tolerances for animal feed.
    i. Food. For the purposes of assessing the potential acute and 
chronic dietary exposure, Syngenta has estimated acute and chronic 
exposure for all registered crops (EPA) pending uses, and newly 
proposed uses. Novigen Sciences Inc. dietary exposure evaluation model 
(DEEM), which is licensed to Syngenta, was used to estimate the chronic 
and acute dietary exposure.
    a. Acute. The DEEM model was used for analysis of individual food 
consumption as reported by the United States Department of Agriculture 
(USDA) (1994-1996 data with supplemental continuing survey of food 
intake by individuals (CSFII) children's survey) using the Tier I 
analysis. The Tier I analysis used tolerance values as anticipated 
residues. Syngenta's acute dietary exposure assessment estimated 
percent of the acute population adjusted dose (aPAD) and corresponding 
margins of exposure (MOE) for the overall U.S. population, and infants/
children, as presented in Table 1.

                                         Table 1.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
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                                                                                         Surface Water
                                                                                           Estimated
                                         aPAD Milligram/                                 Environmental         Ground Water EEC     Acute Drinking Water
       Population Sub-group1          Kilogram/day (mg/kg/     Percent aPAD (Food)    Concentration (EEC)           (ppb)            Levels of Concern
                                              day)                                     Parts Per Billion                               (DWLOC) (ppb)
                                                                                             (ppb)
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U.S. population                      0.67                    12                      170                    0.06                   21,000
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Children (1 to 6 years old)          0.67                    19                      170                    0.06                   5,300
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\1\Within each of these categories, the subgroup with the highest food exposure was selected.

    b. Chronic. The DEEM model was used for analysis of individual food 
consumption as reported by the USDA (1994-1996 data with supplemental 
CSFII children's survey) using the Tier I analysis. The Tier I analysis 
used tolerance values as anticipated residues. Syngenta's chronic 
dietary exposure assessment estimated percent of the

[[Page 21679]]

cPAD and corresponding margins of exposure MOE for the overall U.S. 
population, and infants/children, as presented in Table 2.

                                         Table 2.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
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                                                                                       Surface Water EEC       Ground Water EEC
       Population Sub-group1            cPAD (mg/kg/day)       Percent cPAD (Food)           (ppb)                  (ppb)            Acute DWLOC (ppb)
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U.S. population                      0.18                    14                      33                     0.06                   5,600
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Children (1 to 6 years old)          0.18                    24                      33                     0.06                   1,300
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\1\Within each of these categories, the subgroup with the highest food exposure was selected.

    ii. From 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 based on generic estimated environmental concentration (GENEEC) 
modeling and in ground water based on screening concentration in ground 
water (SCI-GROW) modeling.
    2. From non-dietary uses. Azoxystrobin is registered for 
residential use on ornamentals and turf. The Agency evaluated the 
existing toxicological data base for azoxystrobin and assessed 
appropriate toxicological endpoints and dose levels of concern that 
should be assessed for risk assessment purposes. Dermal absorption data 
indicate that absorption is less than or equal to 4%. Syngenta agrees 
with previous EPA short-term and intermediate-term risk assessments for 
residential exposure which show an aggregate MOE >450 for short-term 
exposure and MOE of >550 for intermediate-term exposure.

D. Cumulative Effects

    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 substance.

E. Safety Determination

    1. U.S. population. The acute dietary exposure analysis showed that 
exposure from the proposed new tolerances the general U.S. population 
would be 12% of the aPAD.
    2. Infants and children. The acute dietary exposure analysis showed 
that exposure from the proposed new tolerances for children 1 to 6 
years old (the subgroup with the highest exposure) would be 19% of the 
aPAD.
    The chronic dietary exposure analysis showed that exposure from the 
proposed new tolerances for children 1 to 6 years old (the subgroup 
with the highest exposure) would be 24% of the cPAD.
    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 analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. In either case, EPA generally defines the 
level of appreciable risk as exposure that is greater than 1/100 of the 
no observed effect level in the animal study appropriate to the 
particular risk assessment. This hundred-fold uncertainty (safety) 
factor/margin of exposure (safety) is designed to account for combined 
interspecies and intraspecies variability. EPA believes that reliable 
data support using the standard hundred-fold margin/factor not the 
additional ten-fold margin/factor 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 
margin/factor. The Agency ad hoc Food Quality Protection Act (FQPA) 
safety factor committee removed the additional 10x safety factor to 
account for sensitivity of infants and children.
    Syngenta has considered the potential aggregate exposure from food, 
water and non-occupational exposure routes and conclude that aggregate 
exposure is not expected to exceed 100% of the aPAD or cPAD and there 
is a reasonable certainty that no harm will result to infants and 
children from the aggregate exposure to azoxystrobin residues.

F. International Tolerances

    There are no Codex MRLs established for azoxystrobin.
[FR Doc. 02-10633 Filed 4-30-02; 8:45 am]
BILLING CODE 6560-50-S