[Federal Register Volume 67, Number 84 (Wednesday, May 1, 2002)]
[Notices]
[Pages 21673-21676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10632]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0015; FRL-6833-7]


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-2002-0015, 
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-2002-0015 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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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Industry                          111                 Crop production

[[Page 21674]]

 
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
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    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-2002-0015. 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 Hwy., 
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-2002-0015 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 Hwy., 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-2002-0015. 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 additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: April 15, 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 by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and

[[Page 21675]]

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 Number 4 (IR-4)

PP 1E6304, 2E6357, 2E6364, 2E6373

    EPA has received pesticide petitions 1E6304, 2E6357, 2E6364 and 
2E6373, 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 180.532 by establishing tolerances for residues of cyprodinil, [4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine], in or on the following 
raw agricultural commodities (RACs):
    1. PP 1E6304 proposes a tolerance for caneberry subgroup at 10.0 
parts per million (ppm).
    2. PP 2E6357 proposes a tolerance for bushberry subgroup, 
lingonberry, juneberry, and salal, at 3.0 ppm.
    3. PP 2E6364 proposes a tolerance for watercress at 20 ppm.
    4. PP 2E6373 proposes a tolerance for pistachio at 0.07 ppm.
    Additional data may be needed before EPA rules on the petitions. 
Syngenta Crop Protection, Inc., Greenboro, NC 27409, is the 
manufacturer of the chemical pesticide, cyprodinil. 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 cyprodinil is adequately 
understood for the purpose of the proposed tolerances.
    2. Analytical method. Syngenta has developed and validated 
analytical methodology for enforcement purposes. This method (Syngenta 
Crop Protection Method AG-631B) has passed an Agency petition method 
validation for several commodities and is currently the enforcement 
method for cyprodinil. An extensive data base of the method validation 
data using this method on various crop commodities is available.
    3. Magnitude of residues. Complete residue data for caneberry 
subgroup, bushberry subgroup, lingonberry, juneberry, salal, pistachio, 
and watercress have been submitted. The requested tolerances are 
adequately supported.

B. Toxicological Profile

    An assessment of toxic effects caused by cyprodinil is discussed in 
Unit III. A. and Unit III. B. of the Federal Register dated June 22, 
2001 (66 FR 33478).
    1. Animal metabolism. The metabolism of cyprodinil in rats is 
adequately understood.
    2. Metabolite toxicology. The residues of concern for tolerance 
setting purposes is the parent compound. Based on structural 
similarities to genotoxic nucleotide analogs, there was concern that 
the pryimidine metabolites (CGA-249287, NOA-422054) may be more toxic 
than the parent compound. However, EPA's review indicates similar 
results in an acute oral and mutagenicity studies with both the parent 
compound and the CGA-249287 metabolite. EPA concluded that the toxicity 
of the CGA-249287 and NOA-422054 metabolites is no greater than that of 
the parent, conditional on submission and review of confirmatory data 
of an acute oral toxicity study and bacterial reverse mutation assay 
for the NOA-422054 metabolite. Although the metabolites CGA-232449 and 
CGA-263208 were determined to be of potential toxicological concern, 
they are not expected to be more toxic than cyprodinil per se.
    3. Endocrine disruption. Cyprodinil does not belong to a class of 
chemicals known or suspected of having adverse effects on the endocrine 
system. Developmental toxicity studies in rats and rabbits and a 
reproduction study in rats gave no indication that cyprodinil might 
have any effects on endocrine function related to development and 
reproduction. The chronic studies also showed no evidence of a long-
term effect related to the endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Permanent tolerances have been established (40 
CFR 180.532(a)) for the residues of cyprodinil, in or on a variety of 
RACs. Tolerance are established on grape at 2.0 ppm, grape, raisin at 
3.0 ppm; onion, dry bulb at 0.6 ppm, onion green at 4.0 ppm; stone 
fruit group at 2.0 ppm, pome fruit group at 0.1 ppm, apple, wet pomace 
at 0.15 ppm; almond nutmeat at 0.02 ppm and almond hulls at 0.05 ppm. 
Time-limited tolerances under section 18 of Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) (emergency exemption) have been 
established under 180.532(b) for caneberry subgroup at 10.0 ppm, and 
strawberry at 5.0 ppm. Tolerances values proposed in this submission 
are: Caneberry subgroup (10.0 ppm); pistachio (0.07 ppm); watercress 
(20 ppm); bushberry subgroup (3.0 ppm), lingonberry (3.0 ppm), 
juneberry (3.0 ppm) and salal (3.0 ppm).
    a. Food. The dietary exposure evaluation was made using the dietary 
exposure evaluation model (DEEM\tm\, version 7.76) from Novigen 
Sciences, Inc. DEEM default processing factors were used along with 
United States Department of Agriculture (USDA) 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. DEEM inputs for all currently registered uses, and proposed 
uses listed above. Secondary residues in animal commodities were not 
considered in this evaluation since calculations showed that residue 
transfers from feed items to livestock and milk were minimal and 
resulted in negligible exposures.
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. EPA has not conducted an acute dietary risk assessment 
since no toxicological endpoint of concern was identified during the 
review of the available data.
    ii. Chronic exposure. This chronic assessment utilized established 
tolerance values for the current uses and proposed tolerance values for 
the added proposed uses. This assessment assumes 100% crop treated for 
all commodities. The chronic population adjusted dose (cPAD) for 
cyprodinil is 0.03 milligram/kilogram (mg/kg) body weight/day (bwt/day) 
and is based on a chronic rat study with a no observed adverse effect 
level (NOAEL) of 2.7 mg/kg bwt/day and a uncertainty factor (UF) of 
100X. No additional Food Quality Protection Act (FQPA) safety factor 
was applied. For the purpose of aggregate assessment, the exposure 
values were expressed in terms of margin of exposure (MOE) which was 
calculated by dividing the NOAEL by the exposure for each population 
subgroup. The benchmark MOE for this assessment is 100. Results from 
the cPAD based risk analysis showed that there were acceptable safety 
margins with respect to chronic exposures incurred by the dietary 
consumption of cyprodinil-treated commodities. Chronic exposures to the 
U.S. population (48 states, all seasons) resulted in a MOE of 1,274 
(7.1% of the total cPAD of 0.03 mg/kg bwt/day). The most sensitive 
subpopulation in the

[[Page 21676]]

chronic assessment was children (1 to 6 years) with a MOE of 354 (25.5% 
of the cPAD). The results of the chronic dietary risk assessment are 
presented in Table 1.
    b. Drinking water exposure. Estimated environmental concentrations 
(EEC's) of cyprodinil in drinking water were determined for the highest 
use rate of cyprodinil, which is almond. Screening concentration in 
ground water (SCI-GROW) (Version 2.1) was used to determine acute and 
chronic EECs in ground water. First (Version 1.0) was used to determine 
acute and chronic EECs in surface water. Based on model outputs, the 
EECs of cyprodinil are 0.0056 parts per billion (ppb) for acute and 
chronic exposure to ground water and 35 ppb and 1 ppb for acute and 
chronic exposure, respectively, to surface water. Chronic drinking 
water levels of comparison (DWLOC) were calculated based on a cPAD of 
0.03 mg/kg/day. For the chronic assessment, children (1 to 6 years) 
subpopulation generated the lowest chronic DWLOC of approximately 224 
ppb. This gave a corresponding MOE value of 27,000. The chronic DWLOC 
of 224 ppb is considerably higher than the chronic EEC of 1 ppb and the 
MOE far exceeds the benchmark MOE of 100. The results for the U.S. 
population and the most sensitive subpopulation are presented in Table 
1.
    2. Non-dietary exposure. Cyprodinil is not registered for use on 
any sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    3. Chronic aggregate exposure. Using the total MOE equation for the 
determination of aggregate exposure (food and drinking water only), 
resulted in an aggregate MOET of 342 for the most sensitive 
subpopulation, children (1 to 6 years). Table 1 summarizes the 
aggregate chronic exposure (food and drinking water only) for 
cyprodinil.

                                                    Table 1.--Cyprodinil Chronic Aggregate Exposures
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                                       Drinking Water MOE       Drinking Water %
        Population Sub-group              \A\, \B\, \C\              cPAD\D\          Food MOE\A\,\B\,\C\       Food % cPAD\D\         MOET \C\, \E\
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U.S. population                      94,5                    0,1                     1,274                  7,1                    1,229
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Children (1 to 6 years)              27                      0,33                    354                    25,5                   342
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\A\MOE= NOAEL/Exposure
 
\B\NOAEL= 3.3 mg/kg body weight/day
 
\C\Benchmark MOE = 100
 
\D\cPAD = 0.03 mg/kg body weight/day
 
\E\MOET = 1/((1/MOEfood)+(1/MOEd.water))

D. Cumulative Effects

    Cumulative exposure to substances with a common mechanism of 
toxicity. 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 cyprodinil 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, cyprodinil does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that cyprodinil has a common 
mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. The chronic dietary exposure analysis showed 
that exposure from the proposed new tolerances for the general U.S. 
population would be 7.1% of the cPAD.
    2. Infants and children. 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 25.5% of 
the cPAD. Therefore, the estimates of dietary exposure clearly indicate 
adequate safety margins for the overall U.S. population.

F. International Tolerances

    There are no Codex maximum residue level's established for 
cyprodinil.
[FR Doc. 02-10632 Filed 4-30-02; 8:45 am]
BILLING CODE 6560-50-S