[Federal Register Volume 70, Number 5 (Friday, January 7, 2005)]
[Notices]
[Pages 1435-1439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-343]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0002; FRL-7694-3]


Cyprodinil; 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 identification (ID) number [OPP-
2005-0002, must be received on or before February 7, 2005.

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: Sidney C. Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; 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 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     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 ID number OPP-2005-0002. 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, 1801 S. Bell St., 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 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

[[Page 1436]]

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-2005-0002. 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-2005-0002. 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-2005-0002.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0002. 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.

[[Page 1437]]

List of Subjects

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


    Dated: December 22, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner 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 4 (IR-4)

PP 8E5012

    EPA has received a pesticide petition, PP 8E5012, from the 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 180.532 by extending the time-limited tolerances to December 31, 
2007, for residues of the fungicide, cyprodinil, 4-cyclopropyl-6-
methyl-N-phenyl-2-pyrimidinamine in or on the raw agricultural 
commodities onion, dry bulb at 0.60 part per million (ppm); onion, 
green at 4.0 ppm; and strawberry at 5.0 ppm. EPA has determined that 
the petition contains 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 petition. Additional data may be 
needed before EPA rules on the petition. Syngenta Crop Protection, 
Inc., Greensboro, NC 27409 is the manufacturer of the chemical 
pesticide, cyprodinil. Syngenta Crop Protection, Inc., 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.
    EPA issued a final rule under section 408(d) of the FFDCA, 21 
U.S.C. 346a(d), on June 22, 2001, (FRL-6778-7), announcing the 
establishment of time-limited pesticide tolerances in conjunction to 
the original pesticide petition (PP 8E5012) which expired December 31, 
2003. These tolerances were time-limited because the Agency lacked 
residue data on onion, dry bulb, onion, green and strawberry. IR-4 
requested an extension of these time limited tolerances to allow extra 
time to generate the field residue data. In the Federal Register of 
December 31, 2003, (68 FR 75438); OPP-2003-0394; (FRL-7337-5) these 
time-limited tolerances were extended with an expiration date of 
December 31, 2004. All residue data have been submitted by IR-4. 
Further the Agency concluded field accumulation in rotational crops 
study for the CGA-249287, NO-422054, CGA-263208, and CGA-232449 
metabolites; and confirmatory data from an acute oral toxicity study 
and Ames assay for the CGA-249287 and NO-422054 metabolites were 
required; all these data have been submitted by Syngenta Crop 
Protection. EPA has been unable to complete the reviews of these data 
prior to the December 31, 2004 expiration date. This time-limited 
tolerance extension will permit the Agency to complete the review of 
these data. Previously EPA evaluated the available cyprodinil data and 
considered their validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk. EPA also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
cyprodinil are adequately understood and support the proposed extension 
of these time-limited tolerances.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of cyprodinil is adequately 
understood for the purpose of the proposed tolerances.
    2. Analytical method. Syngenta Crop Protection 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 database of method 
validation data using this method on various crop commodities is 
available.
    3. Magnitude of residues. Complete residue data to support the 
requested tolerances for strawberry; onion, dry bulb; and onion, green 
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) (FRL-6778-7).
    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, 
there 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. A Tier III acute and chronic dietary exposure 
evaluation was made using the Dietary Exposure Evaluation Model 
(DEEM\TM\), version 7.87 from Exponent. Empirically derived processing 
studies for apple juice (0.39X), apple pomace (5.22X), grape juice 
(0.29X), dried prunes (2.05X) and lychee fruit peeling factor (0.0092X) 
were used in these assessments. The apple juice processing factor was 
used as a surrogate for pear juice and all other processing factors 
used DEEM\TM\ defaults. All consumption data for these assessments were 
taken from the USDA's Continuing Survey of Food Intake by individuals 
(CSFII) with the 1994-96 consumption database and the Supplemental 
CSFII children's survey (1998) consumption database. These

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exposure assessments include all registered uses. Secondary residues in 
animal commodities were estimated based on theoretical worst-case, yet 
nutritionally adequate animal diets and transfer information from 
feeding studies.
    i. Food. For the purposes of assessing the potential dietary 
exposure under the proposed tolerances, Syngenta Crop Protection has 
estimated aggregate exposure from all crops for which tolerances are 
established or proposed. These assessments utilized residue data from 
field trials where cyprodinil was applied at the maximum intended use 
rate and samples were harvested at the minimum pre-harvest interval 
(PHI) to obtain maximum residues. Percent of crop treated values were 
estimated based upon economic, pest and competitive pressures. The 
values used in these assessments were: (Almond, pome fruit, stone fruit 
and grape), 100%; onion, 9%, strawberry, 42%, watercress, 95%; berries, 
13%, (pistachio and herbs), 80%; (crop group 5A and 5B; carrot; turnip, 
greens; lychee; longan; and Spanish lime), 10%.
    ii. Acute exposure. The acute dietary risk assessment was performed 
for the females 13-49 years old population subgroup only, since no 
toxicological endpoint of concern was identified for the other 
population subgroups. An acute reference dose (aRfD) of 1.5 milligrams/
kilograms (mg/kg)-body weight (bw)/day for the females 13-49 years 
subpopulation only was based on a no observable adverse effect level 
(NOAEL) of 150 mg/kg-bw/day based on a rabbit developmental study and 
an uncertainty factor of 100X. No additional FQPA safety factor was 
applied. For the purpose of the aggregate risk assessment, the exposure 
value was expressed in terms of a margin of exposure (MOE), which was 
calculated by dividing the NOAEL by the exposure. In addition, exposure 
was expressed as a percent of the acute reference dose (%aRfD). Acute 
exposure to the females 13-49 years subpopulation resulted in a MOE of 
899 (1.1% of the acute RfD of 1.5 mg/kg-bw/day). Since the benchmark 
MOE for this assessment was 100 and since EPA generally has no concern 
for exposures above the benchmark MOE, Syngenta Crop Protection 
believes that there is a reasonable certainty that no harm will result 
from the acute dietary (food) exposures arising from the current and 
proposed uses for cyprodinil.
    iii. Chronic exposure. The chronic reference dose (cRfD) for 
cyprodinil is 0.03 mg/kg-bw/day and is based on a chronic rat study 
with a NOAEL of 2.7 mg/kg-bw/day and an uncertainly factor of 100X. No 
additional FQPA safety factor was applied. The cyprodinil Tier III 
chronic dietary exposure assessment was based upon residue field trial 
results. For the purpose of the aggregate risk 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. In addition, exposure was expressed as a percent of the 
chronic reference dose (%RfD). Chronic exposure to the most sensitive 
sub-population (children 1 and 2 years old) resulted in a MOE of 1,074 
(8.4% of the chronic RfD of 0.03 mg/kg-bw/day). Since the benchmark MOE 
for this assessment was 100 and since EPA generally has no concern for 
exposures resulting in an MOE above the benchmark MOE, Syngenta Crop 
Protection believes that there is a reasonable certainty that no harm 
will result from the chronic dietary (food) exposures arising from the 
current and proposed uses for cyprodinil.
    2. Drinking water. Another potential source of exposure of the 
general population to residues of cyprodinil are residues in drinking 
water. The degradation of cyprodinil is microbially mediated with an 
aerobic soil metabolism half-life of less than 46 days. Cyprodinil Kocs 
vary from 1550 to 2030 and cyprodinil exhibits a strong binding 
affinity for soil. Cyprodinil is stable to hydrolysis but degrades 
rapidly under photolytic conditions. Estimated Environmental 
Concentrations (EECs) of cyprodinil in drinking water were determined 
by EPA. The EPA ground water model, Screening Concentrations in 
Groundwater (SCI-GROW) was used to determine acute and chronic 
estimated environmental concentrations in ground water and the Agency's 
surface water model, Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS), was used to determine acute and chronic 
estimated environmental concentrations in surface water. Based on the 
model outputs, the estimated environmental concentrations (EECs) for 
cyprodinil (plus the CGA-249287 metabolite) are 0.16 parts per billion 
(ppb) for acute and chronic exposure to ground water and 32.9 ppb and 
8.1 ppb for acute and chronic exposure, respectively, to surface water. 
The Acute Drinking Water Level of Comparison (DWLOC) was calculated 
based on an acute Population Adjusted Dose (aPAD) of 1.5 mg/kg/day. For 
the acute assessment, the females (13-49 years) subpopulation generated 
an acute DWLOC of 44,500 ppb. The acute DWLOC of 44,500 ppb is 
considerably higher than the acute EEC of 32.9 ppb. Chronic DWLOCs were 
calculated based on a chronic Population Adjusted Dose (cPAD) of 0.03 
mg/kg/day. The children 1-2 years old subpopulation generated the 
lowest chronic DWLOC of 275 ppb. Thus, the chronic DWLOC of 275 ppb is 
considerably higher than the chronic EEC of 8.1 ppb.
    3. Non-dietary exposure. There is a potential residential post-
application exposure to adults and children entering residential areas 
treated with cyprodinil. Since the Agency did not select a short-term 
endpoint for dermal exposure, only intermediate dermal exposures were 
considered. Based on the residential use pattern, no long-term post-
application residential exposure is expected.
    4. Chronic aggregate exposure. Based on the completeness and 
reliability of the toxicity data supporting these petitions, Syngenta 
Crop Protection believes that there is a reasonable certainty that no 
harm will result from aggregate exposure to residues arising from all 
current and proposed cyprodinil uses, including anticipated dietary 
exposure from food, water, and all other types of non-occupational 
exposures.

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. For the purposes of this tolerance action, 
the EPA has not assumed that cyprodinil has a common mechanism of 
toxicity with other substances.

E. Safety Determination



    The chronic dietary exposure analysis (food only) indicated that 
exposure from all established and proposed cyprodinil uses is 8.4% of 
the chronic RfD of 0.03 mg/kg-bw/day for the most sensitive 
subpopulation, children 1 and 2 years old. Estimated concentrations of 
cyprodinil residues in surface and ground water are below the 
calculated acute DWLOC. The children 1 and 2 years old subpopulation 
has the lowest

[[Page 1439]]

chronic DWLOC of approximately 275 ppb, which is considerably higher 
than the chronic EEC of 8 ppb.
    The acute dietary exposure analysis (food only) showed that for 
female 13-49 years old, exposure from all established and proposed 
cyprodinil uses would be 1.1% of the acute RfD of 1.5 mg/kg-bw/day. 
Acute DWLOCs were calculated based on an acute Populated Adjusted Dose 
(aPAD) of 1.5 mg/kg/day. The females (13-49 years old) subpopulation 
generated an acute DWLOC of approximately 44,500 ppb. The acute EEC of 
33 ppb is considerably less than 44,500 ppb. Therefore, the chronic and 
aggregate risk from cyprodinil residues in food and drinking water 
would not be expected to exceed the EPA's level of concern.
    Syngenta Crop Protection has considered the potential aggregate 
exposure from food, water and non-occupational exposure routes and 
concluded 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 
cyprodinil.

F. International Tolerances

    There are no Codex maximum residue levels established for 
cyprodinil.

[FR Doc. 05-343 Filed 1-6-05; 8:45 am]
BILLING CODE 6560-50-S