[Federal Register Volume 69, Number 167 (Monday, August 30, 2004)]
[Notices]
[Pages 52891-52897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19713]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0291; FRL-7676-8]


Pyraclostrobin; Notice of Filing a Pesticide Petition to Increase 
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-
2004-0291, must be received on or before September 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: Cynthia Giles-Parker, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7740; 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.

[[Page 52892]]

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-2004-0291. 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 commentors, 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-2004-0291. 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-2004-0291. 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-2004-0291.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information

[[Page 52893]]

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-2004-0291. 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 theelements 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.

List of Subjects

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


    Dated: August 24, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. 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.

BASF Corporation

PP 4F6850

    EPA has received a pesticide petition (4F6850) from BASF 
Corporation, Research Triangle Park, NC, proposing pursuant to section 
408(d) of the FFDCA, 21 U.S.C 346a (d), to amend 40 CFR 180.582 by 
increasing the tolerance for the combined residues of the fungicide 
pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolite BF 500-
3 (methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate), 
expressed as parent compound, in strawberry to 1.5 parts per million 
(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 
this petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant and animal 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) were characterized as parent 
(pyraclostrobin) and BAS 500-3 (methyl-N[[[1-(4-chlorophenyl) pyrazol-
3yl]oxy]o-tolyl] carbamate). In hens the ROC were determined to be 
parent compound and a hydroxylated metabolite, BAS 500-16. In goats the 
ROC were determined to be parent and a hydroxylated metabolite, BAS 
500-10.
    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 GC/MS.
    3. Magnitude of the residue. Field trials were carried out in order 
to determine the magnitude of the residue in strawberry using the 
maximum label rate, the maximum number of applications, and the minimum 
pre-harvest interval.

B. Toxicological Profile

    1. Acute toxicology. 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 IV 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 II, and is not a dermal sensitizer. The 
EG has acute oral and dermal toxicity categories of III, acute 
inhalation of IV, eye irritation of

[[Page 52894]]

III, skin irritation of IV, and is not a dermal sensitizer.
    2. Genotoxicity--i. Ames Test (one study of point mutation): 
Negative;
    ii. In vitro CHO/HGPRT locus mammalian cell mutation assay (one 
study of point mutation): Negative;
    iii. In vitro V79 cells CHO cytogenetic assay (one study of 
chromosome damage): Negative;
    iv. In vivo mouse micronucleus (one study of chromosome damage): 
negative; and
    v. In vitro rat hepatocyte (one study of 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 2-generation study so the NOAEL is the highest dose tested (HDT) of 
300 ppm (32.6 mg/kg bw/day (milligrams per kilogram bodyweight per 
day)). Parental and pup toxicity in the form of reduced bodyweight 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 bw/
day).
    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 doses 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 bw/day and the developmental 
NOAEL was 25 mg/kg bw/day.
    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 postimplantation 
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 are not indicative of frank 
developmental toxicity. The NOAEL for both maternal and developmental 
toxicity was 5 mg/kg bw/day.
    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 highest dose tested of 250 mg/kg 
bw/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 bw/day males; 5.4 
mg/kg bw/day females).
    In an oncogenicity 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 levels as in the 
oncogenicity 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 bw/day males; 4.6 mg/kg bw/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 highest 
doses tested 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 bw/day) for females and 30 ppm (ca. 4.1 mg/kg bw/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 and endocrine effects. No specific tests 
have been conducted with pyraclostrobin to determine whether the 
chemical may

[[Page 52895]]

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 multigeneration 
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 of September 27, 2002 (67 FR 60886; FRL-7200-7). This 
analysis included the current registered crops at the approved 
tolerance values with strawberry at the proposed tolerance of 1.5 ppm.
    The acute and chronic dietary exposure estimates were based on 
established tolerance values (with strawberry at 1.5 ppm), default 
processing factors, 100% crop treated values, and consumption data from 
the USDA Continuing Survey of Food Intake by Individuals (CSFII 1994-
1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) using 
Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.
    Result exposure estimates were compared against the pyraclostrobin 
chronic Population Adjusted Dose (cPAD) and acute Population Adjusted 
Dose (aPAD) of 0.034 mg/kg bw/day and 0.3 mg/kg bw/day for the general 
population, respectively. For females of child bearing years (13-49 
years old) the aPAD is 0.05 mg/kg bw/day. The EPA determined that the 
FQPA Safety Factor should be removed-that is, reduced to 1X for all 
exposure scenarios. Therefore, the acute Population Adjusted Dose 
(aPAD) and the chronic Population Adjusted Dose (cPAD) are the same as 
the aRfD (acute Reference Dose) and cRfD (chronic Reference Dose), 
respectively.
    Results of the chronic dietary assessments are listed in Table 1. 
below. The estimated chronic dietary exposure from current registered 
crops plus strawberry at 1.5 ppm was less than 57% of the cPAD for all 
subpopulations. Additional refinements such as the use of anticipated 
residues, processing factors, and percent crop treated values would 
further reduce the estimated chronic dietary exposure.

  Table 1.--Chronic Dietary Exposure Assessment for Pyraclostrobin (BAS
  500 F) Considering All Currently Registered Crop Uses at the Approved
  Tolerance Values and Strawberry at the Proposed Tolerance of 1.5 ppm
------------------------------------------------------------------------
                                       Exposure
      Population Subgroups        Estimate\1\ (mg/kg       %cPAD\2\
                                        bw/day)
------------------------------------------------------------------------
U.S. Population                   0.005574            16.4
---------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------------------------
\1\Exposure estimates are based on tolerance values, default processing
  factors, and 100% crop treated values
\2\%cPAD = percent of chronic Population Adjusted Dose

    The estimated acute dietary exposure (see Table 2.) for all 
currently registered crops, using the approved tolerance values, plus 
strawberry at the proposed tolerance of 1.5 ppm, was well below the 
Agency's level of concern (100% aPAD). The overall general population 
and the most sensitive subpopulation (females 13-49 years old) utilized 
<6 and <25% of the aPAD at the 95th percentile, respectively. Because 
the FQPA safety factor was reduced to 1X, the aPAD has the same 
percentage utilization as the aRfD. Additional refinements such as the 
use of anticipated residues, processing factors, and percent crop 
treated values would further reduce the estimated acute dietary 
exposure.

 Table 2.--Acute Dietary Exposure Assessment for Pyraclostrobin (BAS 500
    F) Considering All Currently Registered Crop Uses at the Approved
  Tolerance Values and Strawberry at the Proposed Tolerance of 1.5 ppm
------------------------------------------------------------------------
                                    95th Percentile
                                       Exposure
      Population Subgroups        Estimate\1\ (mg/kg       % aPAD\2\
                                        bw/day)
------------------------------------------------------------------------
U.S. Population                   0.017127            5.7
---------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------------------------
\1\Exposure estimates are based on tolerance values, default processing
  factors, and 100% crop treated values
\2\%aPAD = percent of chronic Population Adjusted Dose

    ii. 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 model (for groundwater) produced estimated 
maximum concentrations of 20.4 ppb (acute surface water), 0.79 ppb 
(chronic surface water), and 0.009 ppb (acute and chronic groundwater). 
These estimated concentrations are less than worst-case calculated 
acceptable levels (DWLOC) of pyraclostrobin residues in drinking water 
based on acute and chronic aggregate exposure. Chronic and acute 
drinking water exposure estimates and DWLOCs for pyraclostrobin are 
presented in Tables 3. and 4., respectively.

[[Page 52896]]



Table 3.--Pyraclostrobin (BAS 500 F) Chronic Drinking Water Exposure Estimates for All Currently Registered Crop
                                                      Uses
----------------------------------------------------------------------------------------------------------------
                                                                             Children (1-6     Infants (birth to
          Chronic DWLOC             Adults (20-49)      Females (13-49)         years)                1)
----------------------------------------------------------------------------------------------------------------
No Effect Level                   3.4                 3.4                 3.4                 3.4
------------------------------------------------------
--------------------------------------------------------------------------
---------------------------------=====================
--------------------------------------------------------------------------
--------------------------------------------------------------------------
FIRST (EFED) Surface water        0.79                0.79                0.79                0.79
 ([mu]g/L)
SCI-GROW (EFED) Groundwater       0.009               0.009               0.009               0.009
 ([mu]g/L)
----------------------------------------------------------------------------------------------------------------


 Table 4.--Pyraclostrobin (BAS 500 F) Acute Drinking Water Exposure Estimates for All Currently Registered Crop
                                                      Uses
----------------------------------------------------------------------------------------------------------------
                                                                             Children (1-6     Infants (birth to
           Acute DWLOC              Adults (20-49)      Females (13-49)         years)                1)
----------------------------------------------------------------------------------------------------------------
No Effect Level                   300                 5                   300                 300
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
---------------------------------=====================
--------------------------------------------------------------------------
--------------------------------------------------------------------------
FIRST (EFED) Surface water        20.4                20.4                20.4                20.4
 ([mu]g/L)
SCI-GROW (EFED) Groundwater       0.009               0.009               0.009               0.009
 ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
\1\95th percentile

    iii. Food plus water. The food plus water exposure to 
pyraclostrobin residues is summarized in Table 5.

Table 5.-- Estimated Dietary Exposure to Pyraclostrobin Residues from Food and Water Considering All Currently Registered Crop Uses and Food Residues at
                                       the Approved Tolerances and Strawberry at the Proposed Tolerance of 1.5 ppm
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Exposure                          Infants (0-1 years)      Children (1-6 years)     Adults (20-49 years)    Females (13-49 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food:
Acute Exposure (mg/kg bw/day).......................                 0.025157                  0.04298                 0.011916                 0.012147
Chronic Exposure (mg/kg bw/day).....................                 0.006406                 0.015337                 0.004086                 0.004116
%aPAD...............................................                      8.4                     14.3                      4.0                     24.3
%cPAD...............................................                     18.8                     45.1                     12.0                     12.1
-------------------------------------------------------------------------------
Acute Exposure (mg/kg bw/day).......................                  0.00204                 0.001360                 0.000583                 0.000648
Chronic Exposure (mg/kg bw/day).....................                0.0000009                 0.000001                 0.000000                 0.000000
%aPAD...............................................                    0.680                    0.453                    0.194                    1.295
%cPAD...............................................                    0.003                    0.002                    0.001                    0.001
-----------------------------------------------------

[[Page 52897]]

                                                     ==========================
Acute Exposure (mg/kg bw/day).......................                 0.027197                 0.044340                 0.012499                 0.012795
Chronic Exposure (mg/kg bw/day).....................                0.0064069                 0.015338                 0.004086                 0.004116
%aPAD...............................................                     9.07                    14.78                     4.17                    25.59
%cPAD...............................................                    18.84                    45.11                    12.02                    12.11
--------------------------------------------------------------------------------------------------------------------------------------------------------

    These results indicate that dietary exposure to pyraclostrobin 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 dietary exposure to pyraclostrobin residues.
    2. Non-dietary exposure. Pyraclostrobin is currently registered for 
use on golf course turf. The Agency has evaluated the existing 
toxicological database for pyraclostrobin and has assessed the 
appropriate toxicological endpoints and the dose levels of concern for 
this use. Dermal absorption data indicate that absorption is 14%.

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. 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 
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 are no available data to 
determine whether BAS 500F has a common mechanism of toxicity with 
other substances or to show 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 pesticides.

E. Safety Determination

    1. U.S. population. Adding the proposed tolerance increase in 
strawberry 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 in or on 
the existing label crops, including with the tolerance increase in 
strawberry.
    2. Infants and children. All subpopulations based on age were 
considered. The highest potential exposure was predicted for children 
(1-6 years old). Using the FQPA Safety Factor of 3X when appropriate, 
the addition of the proposed strawberry tolerance increase to the 
tolerances for other crops that are on the label would use less than 1% 
of the aPAD and use 89% of the cPAD for children (1-6 years old). BASF 
concludes that there is reasonable certainty that no harm will result 
to infants or children from aggregate exposure to pyraclostrobin 
residues in or on the existing label crops, including with the 
tolerance increase in strawberry.

F. International Tolerances

    Maximum Residue Levels (MRLs) have been established for 
pyraclostrobin in Canada but no MRLs have been established by the Codex 
Alimentarius Commission.

[FR Doc. 04-19713 Filed 8-27-04; 8:45 am]
BILLING CODE 6560-50-S