[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Pages 48367-48373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20641]



[[Page 48367]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0259; FRL-7320-6]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket ID number OPP-2003-0259, must be 
received on or before September 12, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194]; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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-2003-0259. 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. 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 on 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

[[Page 48368]]

or CD ROM you submit, and in any cover letter accompanying the disk or 
CD ROM. This ensures that you can be identified as the submitter of the 
comment and allows EPA to contact you in case EPA cannot read your 
comment due to technical difficulties or needs further information on 
the substance of your comment. EPA's policy is that EPA will not edit 
your comment, and any identifying or contact information provided in 
the body of a comment will be included as part of the comment that is 
placed in the official public docket, and made available in EPA's 
electronic public docket. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0259. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0259. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0259.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0259. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows; proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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


    Dated: August 5, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner's summary of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions were prepared by Interregional Research Project Number 4 (IR-
4) 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 2E6473, PP 3E6548, and PP 3E6553

    EPA has received pesticide petitions [PP 2E6473, PP 3E6548, and PP 
3E6553] from (IR-4), 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR part 180.582 by establishing tolerances for combined 
residues of the fungicide [pyraclostrobin, carbamic acid, [2-[[[1-(4-
chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester 
and its desmethoxy metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-

[[Page 48369]]

pyrazol-3-yl]oxy]methyl]phenyl carbamate] in or on the following raw 
agricultural commodities: [lettuce, leaf and lettuce, head at 22 parts 
per million (ppm)], [vegetable, leaves of root and tuber, group 2 at 16 
ppm], and [brassica, head and stem, subgroup 5A at 5 ppm]. EPA has 
determined that the petitions contain data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petitions. Additional data 
may be needed before EPA rules on the petitions. This summary has been 
prepared by Bayer Corporation, Research Triangle Park, NC 27709.

A. Residue Chemistry

    1. Plant metabolism. Nature of the residue studies (OPPTS 860.1300) 
were conducted in grape, potato and wheat as representative crops in 
order to characterize the fate of pyraclostrobin in all crop matrices. 
Pyraclostrobin demonstrated a similar pathway and fate in all three 
crops. In all three crops the pyraclostrobin residues of concern (ROC) 
of were characterized as parent (pyraclostrobin) and BAS 500-3), 
methyl-N[[[1-(4-chlorophenyl) pyrazol-3yl]oxy]o-tolyl] carbamate.
    2. Analytical method. In plants the method of analysis is aqueous 
organic solvent extraction, column clean up and quantitation by LC/MS/
MS. In animals the method of analysis involves base hydrolysis, organic 
extraction, column clean up and quantitation by LC/MS/MS or 
derivatization (methylation) followed by quantitation by gas 
chromatography/mass spectrometry (GC/MS).
    3. Magnitude of residues. Field trials were carried out in order to 
determine the magnitude of the residue in the following crops: 
Brassica, head and stem; lettuce, head and leaf; and turnip greens to 
satisfy the requirements for a crop group tolerance for pyraclostrobin 
in leaves of root and tuber vegetables. Field trials were carried out 
using the maximum label rate, the maximum number of applications, and 
the minimum preharvest interval for each crop or crop group.

B. Toxicological Profile

    1. Acute toxicity. Based on available acute toxicity data 
pyraclostrobin and its formulated products do not pose acute toxicity 
risks. The acute toxicity studies place technical pyraclostrobin in 
toxicity category IV for acute oral; category III for acute dermal and 
category II for acute inhalation. Pyraclostrobin is category III for 
both eye and skin irritation, and it is not a dermal sensitizer. Two 
formulated end use products are proposed, an emulsifiable concentrate 
(EC) and an extruded granule (EG). The EC has an acute oral toxicity 
category of II, acute dermal of III, acute inhalation of IV, eye and 
skin irritation categories of III, and is not a dermal sensitizer. The 
WG has acute oral and dermal toxicity categories of III, acute 
inhalation of IV, eye irritation of III, skin irritation of IV and is 
not a dermal sensitizer.
    2. Genotoxicity. Ames test (1 study; point mutation): Negative;in 
vitro. CHO/HGPRT Locus Mammalian Cell Mutation Assay (1 study; point 
mutation): Negative; in vitro V79 Cells CHO Cytogenetic Assay (1 study; 
chromosome damage): Negative; in vivo. Mouse micronucleus (1 study; 
chromosome damage): Negative; in vitro rat hepatocyte (1 study; DNA 
damage and repair): Negative; pyraclostrobin has been tested in a total 
of 5 genetic toxicology assays consisting of in vitro and in vivo 
studies. It can be stated that pyraclostrobin did not show any 
mutagenic, clastogenic or other genotoxic activity when tested under 
the conditions of the studies mentioned above. Therefore, 
pyraclostrobin does not pose a genotoxic hazard to humans.
    3. Reproductive and developmental toxicity. The reproductive and 
developmental toxicity of pyraclostrobin was investigated in a 2-
generation rat reproduction study as well as in rat and rabbit 
teratology studies. There were no adverse effects on reproduction in 
the two-generation study so the no observed adverse effect level 
(NOAEL) is the highest dose tested (HDT) of 300 ppm (32.6 milligrams/
kilogram body weight/day (mg/kg bwt/day). Parental and pup toxicity in 
the form of reduced body weight gain were observed at the HDT only. 
Therefore, the parental systemic and developmental toxicity NOAEL's are 
the same at 75 ppm (8.2 mg/kg bwt).
     No teratogenic effects were noted in either the rat or rabbit 
developmental studies. In the rat study, maternal toxicity observed at 
the mid and high dose consisted of decreased food consumption and body 
weight gain. Developmental changes noted at the high dose were 
increased incidences of dilated renal pelvis and cervical ribs with no 
cartilage. The maternal NOAEL was 10 mg/kg bwt and the developmental 
NOAEL was 25 mg/kg bwt.
     In the rabbit teratology study, maternal toxicity observed at the 
mid and high doses consisted of decreased food consumption and body 
weight gain (severe at the high dose). An increased post-implantation 
loss was also observed at the mid and high doses due to an increase in 
early resorptions. In rabbits, these types of effects are often 
observed with significant stress on the mothers (as seen by the body 
weight gain decrease in this study) and not indicative of frank 
developmental toxicity. The NOAEL for both maternal and developmental 
toxicity was 5 mg/kg bwt.
    4. Subchronic toxicity. The subchronic toxicity of pyraclostrobin 
was investigated in 90-day feeding studies with rats, mice, and dogs, 
and in a 28-day dermal administration study in rats. A 90-day 
neurotoxicity study in rats was also performed. Generally, mild 
toxicity was observed. At high dose levels in feeding studies, general 
findings in all three species were decreased food consumption and body 
weight gain and a thickening of the duodenum. Anemia occurred at high 
dose levels in both rats and mice with accompanying extramedullary 
hematopoiesis of the spleen in rats. In rats only, a finding of liver 
cell hypertrophy was indicative of a physiological response to the 
handling of the chemical. Overall, only mild toxicity was observed in 
oral subchronic testing.
     In the 28-day repeat dose dermal study, no systemic effects were 
noted up to the HDT of 250 mg/kg bwt/day.
     In a 90-day rat neurotoxicity study, a direct neurotoxic effect 
was not observed.
    5. Chronic toxicity. Pyraclostrobin was administered to groups of 5 
male and 5 female purebred Beagle dogs in the diet at concentrations of 
0, 100, 200 and 400 ppm over a period of 12 months. Signs of toxicity 
were observed at the high dose. Diarrhea was observed throughout the 
study period for both sexes. High dose males and females initially lost 
weight and body weight gain was decreased for the entire study period 
for females. Hematological changes observed were an increase in white 
blood cells in males, and an increase in platelets in both sexes at the 
high dose. Clinical chemistry demonstrated a decrease in serum total 
protein, albumin, globulins and cholesterol in high dose animals of 
both sexes possibly due to the diarrhea and reduced nutritional status 
of the animals. The NOAEL was 200 ppm (ca. 5.5 mg/kg bwt/day males; 5.4 
mg/kg bwt/day females).
     In a carcinogenicity study, pyraclostrobin was administered to 
groups of 50 male and 50 female Wistar rats at dietary concentrations 
of 0; 25; 75, and 200 ppm for 24 months. In a companion chronic 
toxicity study, 20 rats/sex were used at the same dose

[[Page 48370]]

levels as in the carcinogenicity study. A body weight gain depression 
of 10-11% in males and 14-22% in females with an accompanying decrease 
in food efficiency was observed at the high dose. The only other effect 
observed was a decrease in serum alkaline phosphatase in both sexes at 
the high dose and decreased alanine aminotransferase in high dose 
males. There was no evidence that pyraclostrobin produced a 
carcinogenic effect in rats. The NOAEL for the chronic rat and the 
cancer rat study is 75 ppm (ca. 3.4 mg/kg bwt/day males; 4.6 mg/kg bwt/
day females).
     Pyraclostrobin was administered to groups of 50 male and 50 female 
B6C3F1 mice at dietary concentrations of 0, 10, 30, 120 and 180 ppm 
(females only) for 18 months. Body weights were reduced at the HDT in 
both males and females. At the high dose, body weight gain decreases of 
27% in females and 29% in males with an accompanying decrease in food 
efficiency were observed. No other signs of toxicity were noted at any 
dose level. The NOAEL was found to be 120 ppm (ca. 20.5 mg/kg bwt/day) 
for females and 30 ppm (ca. 4.1 mg/kg bwt/day) for males. There was no 
evidence that pyraclostrobin produced a carcinogenic effect in mice.
    6. Animal metabolism. In a rat metabolism study with 
pyraclostrobin, 10-13% of the administered dose was excreted in the 
urine and 74-91% in the feces within 48 hours. Excretion via bile was 
significant accounting for 35-38% of the administered dose. By 120 
hours after dosing, very little radioactivity remained in tissues. 
Pyraclostrobin was rapidly and almost completely metabolized. Very 
little unchanged parent was detected. The phase one biotransformation 
is characterized by N-demethoxylation, various hydroxylations, cleavage 
of the ether bond and further oxidation of the two resulting molecule 
parts. Conjugation of the formed hydroxyl groups by glucuronic acid or 
sulfate also occurred. In summary, pyraclostrobin is extensively 
metabolized and rapidly eliminated primarily via the bile, with no 
evidence of accumulation in tissues.
    7. Metabolite toxicology. A comparison of the rat metabolism 
results with the plant metabolism/residue results indicates that 
toxicology studies performed with the parent pyraclostrobin are 
sufficient to cover dietary exposure. Plant residues are primarily the 
parent compound with a fraction (up to 10-20% at most) being the 
demethoxylated parent. This metabolite is referred to as BF 500-3 in 
the plant studies and as 500M07 in the rat study. This metabolite in 
the rat is the first step in the major biotransformation process 
leading to the majority of the metabolites determined in the major 
excretion pathway.
    8. Endocrine disruption. No specific test has been conducted with 
pyraclostrobin to determine whether the chemical may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen or other endocrine effects. However, there were no significant 
findings in other relevant toxicity studies (i.e., subchronic and 
chronic toxicity, teratology and multi-generation reproductive studies) 
which would suggest that pyraclostrobin produces endocrine related 
effects.

C. Aggregate Exposure

    1. Dietary exposure--i. Food Assessments were conducted to evaluate 
the potential risk due to chronic and acute dietary exposure of the 
U.S. population to residues of pyraclostrobin (BAS 500 F). This 
fungicide and its desmethoxy metabolite (BAS 500-3) were expressed as 
the parent compound (BAS 500 F). Tolerance values have previously been 
established for various cereals, vegetables, fruits, and animal 
products and are listed in the U.S. EPA final rule published in the 
Federal Register September 27, 2002 (Vol 67, No. 188, p 60886 60902). 
This analysis included brassica (head & stem), lettuce (head & leaf), 
and leaves of root and tuber vegetables as the target crops.
     The dietary assessment analysis followed an initial tier approach 
with only one refinement. Default processing factors, 100% crop 
treated, and anticipated residue values from the raw agricultural 
commodity (RAC) field studies along with some residue tolerances were 
assumed in the assessment. The CARES 1.1 model with the CSFII/FCID 
consumption data were used to calculated acute and chronic exposure 
estimates.
     Acute dietary exposure. The estimated acute dietary exposure 
estimates for the crops listed were well under 100% of the aPAD at the 
95th percentile (Table 2). The overall general population 
and the most sensitive subpopulation (females 13-49 years) utilized < 
0.15% and 7.8% of the aRfD, respectively. The %aPAD ranged from 0.1 to 
22.9% for all subpopulations.

 
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                             Population                                    Exposure Estimate                %aRfD                       %aPAD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subgroups                                                                         (mg/kg bwt/day)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Birth to 1 year                                                                0.00045           .02                .02
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-2 years                                                                                0.003053                     0.10                          0.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-5 years                                                                                0.003297                     0.11                          0.11
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-6 years                                                                                0.003215                     0.11                          0.11
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-12 years                                                                               0.002884                     0.10                          0.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-19 years                                                                              0.002515                     0.08                          0.08
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years                                                                      0.003888                     7.78                         22.87
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males 20-49 years                                                                        0.003405                     0.11                          0.11
--------------------------------------------------------------------------------------------------------------------------------------------------------

     Chronic: Results of the chronic dietary exposure assessments are 
listed below. The estimated chronic dietary exposure from the crops 
listed above was less than 5.5% and 16.5% of the cRfD and cPAD for all 
subpopulations, respectively.

[[Page 48371]]



 
----------------------------------------------------------------------------------------------------------------
            Population                   Exposure Estimate             %cRfD                    %cPAD
----------------------------------------------------------------------------------------------------------------
Subgroups                              milligrams/kilogram body
                                     weight/day (mg/kg bwt/day)
----------------------------------------------------------------------------------------------------------------
Birth to 1 year                                       0.0002888               0.85                2.63 1-2 years
----------------------------------------------------------------------------------------------------------------
0.0013                                                     3.82              11.82                     3-5 years
----------------------------------------------------------------------------------------------------------------
0.001731                                                   5.09              15.74                     1-6 years
----------------------------------------------------------------------------------------------------------------
0.00161                                                    4.74              14.64                    6-12 years
----------------------------------------------------------------------------------------------------------------
0.001336                                                   3.93              12.15                   13-19 years
----------------------------------------------------------------------------------------------------------------
0.001788                                                   5.26              16.25           Females 13-49 years
----------------------------------------------------------------------------------------------------------------
0.001788                                                   5.26              16.25             Males 20-49 years
----------------------------------------------------------------------------------------------------------------
0.001577                                                   4.64              14.34              Adults 50+ years
----------------------------------------------------------------------------------------------------------------
0.001647                                                   4.84              14.97
----------------------------------------------------------------------------------------------------------------

     Results of the chronic and acute dietary exposure analysis 
demonstrate a reasonable certainty that no harm to the general U.S. 
population or any subpopulation would results from the use of 
pyraclostrobin on brassica (head & stem), lettuce (head & leaf), and 
leaves of root and tuber vegetables.
     To ensure that these additional uses on the proposed crops fits 
within the total risk cup, a dietary exposure assessment (as described 
above considering 100% CT and residue values) was conducted with the 
most sensitive subpopulation (females 13-49 years) using all previously 
registered and current proposed crops for pyraclostrobin. The dietary 
risk assessment conducted by the EPA and published in the Federal 
Register (Vol 67, No. 188, p 60886 60902) showed that the acute dietary 
exposure for all subpopulation groups (except females 13-50 years of 
age) was < 1% of the aPAD. For females 13 50 years of age, the acute 
dietary exposure accounted for 41% of the aPAD. The EPA dietary 
assessment was considered partially refined and somewhat conservative 
since the percent crop treated data, some concentration factors, and 
tolerance levels were used. The total acute dietary exposure for 
females 13-49 years of age from currently registered and proposed new 
uses accounts for 63.87% (22.87 + 41 = 63.87) of the aPAD. The dietary 
risk assessment conducted by the EPA and published in the Federal 
Register showed that the highest chronic dietary exposure (74% of the 
cPAD) occurred in children 1-6 years of age. The total chronic dietary 
exposure for children 1-6 years of age from currently registered and 
proposed new uses accounts for 88.64% (14.64 + 74 = 88.64) of the cPAD.

2. Drinking Water

     There are no established maximum contaminant levels or health 
advisory levels for residues of pyraclostrobin (BAS 500 F) or its 
metabolite in drinking water. A tier 1 drinking water modeling 
assessment for pyraclostrobin using the FIRST model (for surface water) 
and SCI-GROW (for ground water) produced estimated maximum 
concentrations of 20.4 ppb (acute surface water), 0.74 parts per 
billion (ppb) (chronic surface water) and 0.009 ppb (acute and chronic 
groundwater). These estimated concentrations are less than worst-case 
calculated acceptable drinking water levels of concern (DWLOC) of 
pyraclostrobin residues in drinking water based on acute and chronic 
aggregate exposure for both registered and pending crops (see table 
below).

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Child                     Adult female                         Adult male
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      (1-6 years)                 (13-49 years)                            (20-49 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
water consumption (L)                                                           1                             2                                        2
--------------------------------------------------------------------------------------------------------------------------------------------------------
weight kilogram (kg)                                                           10                            60                                       70
--------------------------------------------------------------------------------------------------------------------------------------------------------
cPAD (mg/kg bwt/day)                                                        0.011                         0.011                                    0.011
--------------------------------------------------------------------------------------------------------------------------------------------------------
food exposure (mg/kg bwt/day) chronic                                     0.00981                       0.00398                                 0.004377
--------------------------------------------------------------------------------------------------------------------------------------------------------
Max. water exposure (mg/kg bwt/day)-chronic                               0.00119                       0.00702                                 0.006623
--------------------------------------------------------------------------------------------------------------------------------------------------------
DWLOC ([mu]g/L) chronic                                                      11.9                         210.6                                    231.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
aPAD (mg/kg bwt/day)                                                            3                         0.017                                        3
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 48372]]

 
Food exposure (mg/kg bwt/day) - acute                                     0.02521                       0.01068                                 0.011705
--------------------------------------------------------------------------------------------------------------------------------------------------------
max. waterexposure (mg/kg bwt/day)-acute                                  2.97479                       0.00632                                 2.988295
--------------------------------------------------------------------------------------------------------------------------------------------------------
DWLOC ([mu]g/L) - acute                                                   29747.9                         189.6                                   104590
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. Aggregate Exposure (Diet + Water)

     The aggregate exposure of pyraclostrobin residues is summarized in 
the table below. Although, BASF has submitted an application for 
registration of pyraclostrobin in residential turf areas (March 2000), 
this particular use has been reserved pending the outcome of EPA 
reviews of additional toxicology studies submitted by BASF, and 
therefore, residential exposure was not included in the aggregate 
exposure assessment.

----------------------------------------------------------------------------------------------------------------
                                                      Infants        Children                          Women
                    Exposure                     --------------------------------  Males (20-49  ---------------
                                                    (0-1 years)     (1-6 years)       years)       (13-50 years)
----------------------------------------------------------------------------------------------------------------
                                              FOOD (mg/kg bwt/day)
----------------------------------------------------------------------------------------------------------------
Acute Exposure (registered uses)                           0.014           0.022          0.0083          0.0068
-------------------------------------------------
Acute Exposure (new uses)                                0.00045        0.003215        0.003405        0.003888
----------------------------------------------------------------------------------------------------------------
Total acute exposure                                     0.01445        0.025215        0.011705        0.010688
----------------------------------------------------------------------------------------------------------------
Chronic Exposure (registered uses)                        0.0034          0.0082          0.0028          0.0022
----------------------------------------------------------------------------------------------------------------
Chronic Exposure (new uses)                            0.0002888         0.00161        0.001577        0.001788
----------------------------------------------------------------------------------------------------------------
Total Chronic Exposure                                 0.0036888         0.00981        0.004377        0.003988
----------------------------------------------------------------------------------------------------------------
%aPAD                                                       0.48            0.84            0.39           62.87
----------------------------------------------------------------------------------------------------------------
%cPAD                                                      33.53           89.18           39.79           36.25
----------------------------------------------------------------------------------------------------------------
                                                      WATER
----------------------------------------------------------------------------------------------------------------
Acute Exposure (mg/kg b.w./day)                          0.00204         0.00136        0.000583        0.000648
-------------------------------------------------
Chronic Exposure (mg/kg b.w./day)                      0.0000009       0.0000006       0.0000003       0.0000003
----------------------------------------------------------------------------------------------------------------
%aPAD                                                       0.07            0.05            0.02            3.81
----------------------------------------------------------------------------------------------------------------
%aPAD                                                      0.003           0.002           0.001           0.001
----------------------------------------------------------------------------------------------------------------
                                                    AGGREGATE
----------------------------------------------------------------------------------------------------------------
Acute Exposure (mg/kg bwt/day)                           0.01649        0.026575        0.012288        0.011336
-------------------------------------------------
Chronic Exposure (mg/kg bwt/day)                       0.0036897       0.0098106       0.0043773       0.0039883
----------------------------------------------------------------------------------------------------------------
%aPAD                                                       0.55            0.89            0.41           66.68
----------------------------------------------------------------------------------------------------------------
%aPAD                                                      33.54           89.19           39.79           36.26
----------------------------------------------------------------------------------------------------------------

     These results indicate the aggregate exposure of pyraclostrobin 
(registered use and the proposed crops in this document), from 
potential residues in food and water, will not exceed the U.S. EPA's 
level of concern (100% of PAD). Overall, we can conclude with 
reasonable certainty that no harm will occur from either acute or 
chronic aggregate exposure of pyraclostrobin residues.

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.' Pyraclostrobin is a foliar fungicide 
which belongs to the new class of strobilurin chemistry. It is a 
synthetic analog of strobilurin A, a naturally occurring antifungal 
metabolite of the mushroom Strobillurus tenacellus (Anke et. al., 
1977). The active ingredient acts in the fungal cell through inhibition 
of electron transport in the mitochondrial respiratory chain at the 
position of the cytochrome-bc1 complex. The protective effect is due to 
the resultant death of the fungal cells by disorganization of the 
fungal membrane

[[Page 48373]]

system. Pyraclostrobin also acts curatively to prevent the increase and 
spread of fungal infections by inhibiting mycelial growth and 
sporulation on the leaf surface. BAS 500F inhibits spore germination, 
germ tube growth and penetration into the host tissues.
     The EPA is currently developing methodology to perform cumulative 
risk assessments. At this time, there is no available data to determine 
whether BAS 500F 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, 
pyraclostrobin does not appear to produce a toxic metabolite produced 
by other substances.

E. Safety Determination.

     U.S. population. Adding the proposed uses to those crops already 
on the pyraclostrobin label, aggregate exposure to adults in the U.S. 
population utilized at most 67% of the aPAD and 40% of the cPAD. 
Therefore, no harm to the overall U.S. population would result from the 
use of pyraclostrobin on the proposed and existing label crops.
     Infants and children. All subpopulations based on age were 
considered. The highest potential exposure was predicted for children 
age 1-6. Using the FQPA safety factor of 3X when appropriate, the 
addition of the proposed crops to those on the label would use less 
than 1% of the aPAD and use 89% of the cPAD for children age 1-6. BASF 
concludes that there is reasonable certainty that no harm will result 
to infants or children from aggregate exposure to pyraclostrobin 
residues on the proposed and existing label crops.

F. International Tolerances.

     Maximum Residue Levels (MRLs) have been established for 
pyraclostrobin in Canada. No MRLs have been established by the Codex 
Alimentarius Commission.
[FR Doc. 03-20641 Filed 8-12-03; 8:45 am]
BILLING CODE 6560-50-S