[Federal Register Volume 69, Number 39 (Friday, February 27, 2004)]
[Rules and Regulations]
[Pages 9315-9320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-416]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0053; FRL-7346-7]


Propiconazole; 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.

-----------------------------------------------------------------------

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

DATES: Comments, identified by docket ID number OPP-2004-0053, must be 
received on or before March 29, 2004.

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: Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; 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 identification (ID) number OPP-2004-0053. 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 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.

[[Page 9316]]

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-2004-0053. 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-2004-0053. 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-2004-0053.
    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-2004-0053. 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

[[Page 9317]]

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 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 the petitions contain 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 petitions. 
Additional data may be needed before EPA rules on the petitions.

List of Subjects

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

    Dated: February 20, 2004.
Kathy S. Monk,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petitions is printed below 
as required by FFDCA section 408(d)(3). The summary of the petitions 
was prepared by the petitioner and represents the view of the 
petitioner. The petitions 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.

Syngenta Crop Protection, Inc.

PP 8F3654 and PP 8F3674

    EPA has received pesticide petitions (PP 8F3654 and PP 8F3674) from 
Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-
8300 proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR 180.434 by extending the time-limited tolerances for 
residues of propiconazole (1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole) in or on corn, field, forage 
at 12 parts per million (ppm); corn, field, grain at 0.1 ppm; corn, 
field, stover at 12 ppm; corn, sweet, kernel plus cob with husks 
removed at 0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm 
(8F3674); peanuts at 0.2 ppm; and peanuts, hay at 20 ppm (8F3654).

A. Residue Chemistry

    1. Plant metabolism. The metabolism of propiconazole as well as the 
nature of the residues is adequately understood for purposes of the 
tolerances. Plant metabolism has been evaluated in five diverse crops, 
wheat, grapes, celery, peanuts and carrots which should serve to define 
the similar metabolism of propiconazole in a wide range of crops. The 
plant metabolism pathway for propiconazole is well understood. Parent 
metabolite CGA-64250 is the major compound found in crops. Comparison 
of the metabolism of propiconazole in different plant species shows 
that the differences between the respective metabolic pathways to be 
quantitative in nature.
    2. Analytical method. The metabolism data in plants and animals 
suggest that analytical methods to detect either the phenyl or the 
triazole ring would be appropriate for the measurement of residues. 
However, because of the natural occurrence of compounds that interfere 
with the measurement of triazoles, methods designed to detect this 
moiety have been proven unreliable and unacceptable. Conversely, 
conversion of phenyl moiety to 2,4-dichlorobenzoic acid (DCBA) has 
proven to be satisfactory for all agricultural products analyzed to 
date. Analytical method AG-454A was developed for the determination of 
residues of propiconazole and its metabolites containing the DCBA 
moiety. This method has been accepted and published by EPA as the 
tolerance enforcement method for crops. The limit of quantitation (LOQ) 
for the method is 0.05 ppm.
    3. Magnitude of residues. Field residue trials have been conducted 
at various rates, timing intervals, and applications methods to 
represent the use patterns which would most likely result in the 
highest residues. For all samples, the total residue method was used 
for determination of the combined residues of parent and its 
metabolites which contain the DCBA moiety.

B. Toxicological Profile

    1. Acute toxicity. Propiconazole exhibits low toxicity. Data 
indicated the following: A rat acute oral lethal dose (LD)50 
of 1,517 milligrams/kilogram (mg/kg); a rabbit acute dermal 
LD50 >6,000 mg/kg; a rat inhalation lethal concentration 
(LC)50 >5.8 mg/liter air; minimal skin and slight eye 
irritation; and nonsensitization.
    2. Genotoxicty. Propiconazole exhibits no mutagenic potential based 
on the following data: In vitro gene mutation test (Ames assay, rat 
hepatocyte DNA repair test, (human fibroblast DNA repair test); in 
vitro chromosome test, (human lymphocyte cytogenetic test); in vivo 
mutagenicity test, (Chinese hamster bone marrow cell nucleus anomaly 
test, Chinese hamster bone marrow cell micronucleus test, mouse 
dominant lethal test); and other mutagenicity test (BALB/3T3 cell 
transformation assay).
    3. Reproductive and developmental toxicity. In an oral teratology 
study in the rabbit, a maternal no observed adverse effect level 
(NOAEL) of 30 mg/kg was based on reduced food intake but without any 
fetotoxicity even at the top dose of 180 mg/kg. In an oral teratology 
study in the rabbit, a maternal NOAEL of 100 mg/kg was based on 
reductions in body weight gain and food consumption and a fetal NOAEL 
of 250 mg/kg was based on increased skeletal variations at 400 mg/kg. 
In an oral teratology study in the rat, a maternal and fetal NOAEL of 
100 mg/kg was based on decreased survival, body weight gain, and food 
consumption in the dams and delayed ossification in the fetuses at 300 
mg/kg. In a second teratology study in the rat, a maternal and fetal 
NOAEL of 30 mg/kg was based on reductions in body weight gain and food 
consumption in the dams and delayed development in the fetuses at 90 
and 360/300 mg/kg. A supplemental teratology study in the rat involving 
eight times as many animals per group as usually required showed no 
teratogenic potential for the compound. A 2-generation reproduction 
study in the rat showed excessive toxicity at 5,000 ppm without any 
teratogenic effects. A 2-generation reproduction study in the rat 
showed no effects on reproductive or fetal parameters at any dose 
level. Postnatal growth and survival were affected at the top dose of 
2,500 ppm, and parental toxicity was also evident. The NOAEL for 
development toxicity is 500 ppm.
    4. Subchronic toxicity. In a 21-day dermal study in the rabbit, a 
NOAEL of 200 mg/kg was based on clinical signs of systemic toxicity. In 
a 28-day oral toxicity study in the rat, a NOAEL of 50 mg/kg was based 
on increased liver weight. In a subchronic feeding study in the mouse, 
a NOAEL of 20 ppm (3 mg/kg) was based on liver pathologic changes. In a 
13-week feeding study in the male mouse, a NOAEL of 20 ppm (3 mg/kg) 
was based on liver pathologic changes. In a 90-day feeding study in 
rats, the NOAEL was 240 ppm (24 mg/kg) based on a reduction in body 
weight gain. In a 90-day feeding study in dogs,

[[Page 9318]]

the NOAEL was 250 ppm (6.25 mg/kg) based on reduced food intake and 
stomach histologic changes.
    5. Chronic feeding toxicity and carcinogenicity. In a 12-month 
feeding study in the dog, a NOAEL of 50 ppm (1.25 mg/kg) was based on 
stomach histologic changes. In a 24-month oncogenicity feeding study in 
the mouse, the NOAEL was 100 ppm (15 mg/kg). The maximum tolerated dose 
(MTD) was exceeded at 2,500 ppm in males based on decreased survival 
and body weight. Increased incidence of liver tumor was seen in these 
males but no evidence of carcinogenicity was seen at the next lower 
dose of 500 ppm in either sex. In a 24-month chronic feeding/
oncogenicity study in the rat, a NOAEL of 100 ppm (5 mg/kg) was based 
on body weight and blood chemistry. The MTD was 2,500 ppm based on 
reduction in body weight gain and no evidence of oncogenicity was seen. 
Based on the available chronic toxicity data, Syngenta believes the 
reference dose (RfD) for propiconazole is 0.0125 mg/kg/day. This RfD is 
based on a 1 year feeding study in dogs with a NOAEL of 1.25 mg/kg/day 
(50 ppm) and an uncertainly factor of 100. No additional modifying 
factor for the nature of effects was judged to be necessary as stomach 
mucous hyperemia was the most sensitive indicator of toxicity in that 
study.
    Using the ``Guidelines for Carcinogenic Risk Assessment'' published 
on September 24, 1986 (51 FR 33992), EPA has classified propiconazole 
in Group C for carcinogenicity (evidence of possible carcinogenicity 
for humans). The compound was tested in 24-month studies with both rats 
and mice. The only evidence of carcinogenicity was an increase in liver 
tumor incidence in male mice at a dose level that exceeded the MTD. 
Dosage levels in the rat study were appropriate for identifying a 
cancer risk. The Cancer Peer Review Committee recommended the RfD 
approach for quantitation of human risk. Therefore, the RfD is deemed 
protective of all chronic human health effects, including cancer.
    6. Animal metabolism. Metabolism in animals is similar to plant 
metabolism. In animals both the rat and the goat rapidly metabolize and 
excrete propiconazole. Neither animal retains significant amounts of 
propiconazole or its metabolites in tissues. Significant quantities of 
parent or metabolites do not appear in goat's milk. Similar metabolites 
are produced by both species, and unconjugated (Phase I) metabolites 
are similar in plants and animals.
    The metabolism profile supports the use of an analytical 
enforcement method that accounts for combined residues of propiconazole 
and its metabolites that contain the DCBA moiety.
    7. Metabolite toxicology. There are no metabolites of concern based 
on a differential metabolism between plants and animals.
    8. Endocrine disruption. Developmental toxicity studies in rats and 
rabbits and reproduction studies in rats gave no indication that 
propiconazole might have any effects on endocrine function related to 
development and reproduction. The subchronic and chronic studies also 
showed no evidence of a long-term effect related to the endocrine 
system. Further, due to the moderate rate of degradation of the 
product, there is no risk that propiconazole may accumulate in the 
environment. In animals, propiconazole is quickly excreted and has no 
tendency for accumulation in the body. Based on these results, it is 
very likely that propiconazole has no potential to interfere 
specifically with the endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Tier III/IV acute and chronic dietary exposure 
evaluations were completed using the Dietary Exposure Evaluation Model 
(DEEM\TM\), version 7.87 from Exponent. All consumption data for these 
assessments was taken from the U.S. Department of Agriculture'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 exposure assessments included all 
registered crop uses (almonds, apricots, bananas, barley, blueberries, 
celery, cherries, corn (field), corn (sweet), cranberries, dry beans 
and peas, filberts (hazelnuts), grasses grown for seed, nectarines, 
oats, peaches, peanuts, pecans, peppermint, pineapples, plums, prunes, 
raspberries, rice, rye, spearmint, sorghum, sugar cane, wheat and wild 
rice). Empirically derived processing studies for peanut oil (0.37X), 
sorghum aspirated grain fractions (5.21X), spearmint oil (0.66X), and 
sorghum flour (0.23X) were used in these assessments. All other 
processing factors used DEEM\TM\ defaults. Secondary residues in animal 
commodities were estimated based on theoretical worst-case, yet 
nutritionally adequate animal diets and residue transfer factors 
calculated from feeding studies.
    a. Food. For the purposes of assessing the potential dietary 
exposures under the current tolerances, Syngenta estimated aggregate 
exposures from all crops for which tolerances are established. These 
assessments utilized residue data from field trials where propiconazole 
was applied at the maximum intended use rate and samples were harvested 
at the minimum pre-harvest interval (PHI) to obtain maximum residues. 
In these Tier III/IV dietary exposure assessments, Syngenta Market 
Basket Survey residue data was used for the following commodities: 
Bananas, celery, sweet corn, cherries, peaches, peanut butter and wheat 
flour. Percent of crop treated (%CT) values were based on Doane's 2001 
data base. Since percent crop treated is inherent in the market basket 
data, no percent crop treated correction was used for commodities 
analyzed in the Syngenta Market Basket Survey.
    i. Acute exposure. An acute reference dose of 0.30 mg/kg bwt/day 
for the females 13-50 years subpopulation only was based on a NOAEL of 
30 mg/kg bwt/day from a rat developmental toxicity study and an 
uncertainly factor of 100X. The 100-fold safety factor includes 
intraspecies and interspecies variations. No additional FQPA safety 
factor was applied. Acute exposure to the females 13-50 years 
subpopulation was expressed as a percent of the acute RfD. Acute 
dietary exposure to females 13-50 years old at the 99.9th percentile of 
exposures was negligible (0.3% of the acute RfD of 0.30 mg/kg body 
weight/day). Since EPA generally has no concern for exposures below 
100% of the RfD, Syngenta believes that there is a reasonable certainty 
that no harm will result from dietary (food) exposure to residues 
arising from the current uses of propiconazole.
    ii. Chronic exposure. The chronic reference dose (RfD) of 
propiconazole is 0.0125 mg/kg bwt/day and is based on a chronic dog 
feeding study with a NOAEL of 1.25 mg/kg bwt/day and an uncertainly 
factor of 100X. The 100-fold safety factor includes intraspecies and 
interspecies variations. No additional FQPA safety factor was applied. 
Exposures were expressed as a percent of the chronic RfD. Chronic 
exposure to the most exposed subpopulation (children 1 and 2 years old) 
was 0.5% of the chronic RfD of 0.0125 mg/kg bwt/day. Since EPA 
generally has no concern for exposures below 100% of the RfD, Syngenta 
believes that there is a reasonable certainty that no harm will result 
from dietary (food) exposure to residues arising from the current uses 
of propiconazole.
    b. Drinking water. EPA uses the Pesticide Root Zone/Exposure 
Analysis Modeling System (PRZM/EXAMS) to

[[Page 9319]]

estimate pesticide concentrations in surface water and Screening 
Concentration in Ground Water (SCI-GROW) to predict pesticide 
concentrations in ground water. None of these models include 
consideration of the impact processing of raw water (mixing, dilution, 
or treatment) for distribution as drinking water would likely have on 
the removal of pesticides from the source water. The primary use of 
these models by the Agency at this stage is to provide a conservative 
approximation of the estimated environmental concentration (EEC) of 
specific pesticides in drinking water. The highest use rate for 
propiconazole is on turf; therefore, this use was evaluated to assess 
the potential environmental exposure to drinking water. For ground 
water (SCI-GROW) modeling, Syngenta has determined that EECs of 
propiconazole at the highest use rate (1.77 pound/active ingredient/
acre x 4 applications, turf use) are 1.48 parts per billion (ppb) for 
both acute and chronic exposure. Using the same propiconazole use rate 
for surface water (PRZM/EXAMS) modeling, acute and chronic EECs were 
4.69 ppb and 2.99 ppb, respectively. EECs of propiconazole are compared 
to the acute and chronic Drinking Water Levels of Comparison (DWLOC). 
Since the surface water EECs exceed the ground water EECs, the surface 
water values will be used for comparison purposes and will be 
considered protective for any ground water concentration concerns.
    i. Chronic risk. DWLOCs were calculated based on a chronic 
Population Adjusted Dose (PAD) of 0.013 mg/kg/day. Chronic drinking 
water exposure represents 2.3% of the chronic PAD for a 10 kg child 
consuming 1 L water/day. The children 1 to 2 years subpopulation 
generated the lowest chronic DWLOC of 129 ppb. Since the chronic DWLOC 
of 129 ppb is considerably higher than the chronic EEC of 2.99 ppb, EPA 
should not have a concern for chronic risk to either surface water or 
ground water.
    ii. Acute risk. The acute DWLOC was calculated based on an acute 
PAD of 0.30 mg/kg/day. Acute drinking water exposure represents 0.05% 
of the acute PAD for a 60 kg female consuming 2 L water/day. The 
females 13 years and older subpopulation is the only subgroup of 
concern and generated an acute DWLOC of 8,972 ppb. Since the acute 
DWLOC of 8,972 ppb is considerably higher than the acute EEC of 4.69 
ppb, EPA should not have a concern for acute risk to either surface 
water or ground water.
    2. Non-dietary exposure. Propiconazole is registered for 
residential use as a preservative treatment for wood and for lawn and 
ornamental uses. At this time, no reliable data exist which would allow 
quantitative incorporation of risk from these uses into a human health 
risk assessment. The exposure to propiconazole from contacting treated 
wood products is anticipated to be very low since the surface of wood 
is usually coated with paint or sealant when used in or around the 
house. The non-occupational exposure from lawn and ornamental 
applications is also considered to be minor. It is estimated that less 
than 0.01% of all households nationally use propiconazole in a 
residential setting.
    3. Aggregate exposure. Based on the completeness and reliability of 
the toxicity data supporting these petitions, Syngenta believes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues arising from current propiconazole uses, including 
anticipated dietary exposure from food, water, and all other types of 
non-occupational exposures.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' EPA does not have, at this time, 
available data to determine whether propiconazole 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, EPA has not assumed that propiconazole has a common 
mechanism of toxicity with other substances.

E. Safety Determination

    The dietary exposure assessment for propiconazole showed that there 
were acceptable safety margins with respect to both chronic and acute 
exposure through the dietary consumption of propiconazole-treated 
commodities. The most sensitive subpopulation was children (1-2 years 
old) with a chronic exposure of 0.5% of the chronic reference dose of 
0.0125 mg/kg bwt/day. Females 13 years and older is the only population 
subgroup of concern for the acute dietary exposure assessment. Dietary 
exposure to females (13-50 years old) at the 99.9th percentile of 
exposure was negligible (0.3% of the acute RfD of 0.30 mg/kg bwt/day).
    EPA has determined that reliable data support using the standard 
MOE and uncertainty factor (100 for combined interspecies and 
intraspecies variability) for propiconazole and that an additional 
safety of 10 is not necessary to be protective of infants and children.
    For the drinking water portion of the aggregate assessment, the 
EECs of propiconazole in surface water were greater than those for 
ground water. Surface water EECs were 4.69 ppb and 2.99 ppb for acute 
and chronic exposure, respectively. The chronic DWLOC was calculated as 
129 ppb for the most sensitive subgroup, children (1-2 years old). For 
the acute assessment, the females 13 years and older subpopulation is 
the only subgroup of concern and provided an acute DWLOC of 8,972 ppb. 
Since both chronic and acute EECs were well below the chronic and acute 
DWLOCs, there should be no concern for acute risk from either surface 
water or ground water.
    Exposure from non-food sources, residential and lawn applications 
of propiconazole products, is considered to be negligible. Based upon 
the current chronic and acute aggregate exposure analysis, aggregate 
exposures are below 100% of the chronic and acute reference doses. The 
worst-case chronic food exposure for children 1-2 years old represents 
0.5% of the chronic RfD of 0.0125 mg/kg bwt/day. The worst-case chronic 
drinking water exposure for children 1-2 years old (based upon surface 
water modeling) represents 2.3% of the chronic reference dose. Since 
the residential exposure for propiconazole is negligible, the worst-
case aggregate chronic risk (food plus drinking water) is approximately 
3%. The worst-case aggregate acute risk (food plus drinking water) to 
females (13-50 years old) at the 99.9th percentile of exposure is 
negligible (0.3% of the acute RfD of 0.30 mg/kg bwt/day).
    Syngenta 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 and acute RfDs 
and there is a reasonable certainty that no harm will result to any 
populations subgroups, including infants and children, from the 
aggregate exposure to propiconazole.

F. International Tolerances

    International CODEX values are established for almond, animal 
products, bananas, barley, coffee, eggs, grapes, mango, meat, milk, 
oat, peanut-whole, peanut grains, pecans, rape, rye, stone fruit, sugar 
cane, sugar beets, sugar beet tops, and wheat. The U.S.

[[Page 9320]]

residue definition includes both propiconazole and metabolites 
determined as 2,4-dichlorobenzoic acid (DCBA), while the CODEX 
definition is for propiconazole, per se, i.e. parent only. This 
difference results in unique tolerance expressions with the U.S. 
definition resulting in the higher tolerance levels.
[FR Doc. E4-416 Filed 2-26-04; 8:45 am]
BILLING CODE 6560-50-S