[Federal Register: August 27, 2004 (Volume 69, Number 166)]
[Notices]
[Page 52670-52679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au04-36]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0292; FRL-7676-9]
Pyraclostrobin; Notice of Filing of Four Pesticide Petitions to
Establish Tolerances for a Certain Pesticide Chemical in and 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-
2004-0292, must be received on or before September 27, 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:
giles-parker.cynthia@epa.gov.
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, pesticide manufacturer, or
consume agricultural commodities. Potentially affected entities may
include, but are not limited to:
Crop production (NAICS 111)
Farming (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0292. 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 South Bell St., Arlington, VA.
[[Page 52671]]
This docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view
public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Although not all docket
materials may be available electronically, you may still access any of
the publicly available docket materials through the docket facility
identified in Unit I.B.1. Once in the system, select ``search,'' then
key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The 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-2004-0292. 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 opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0292. 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-2004-0292.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0292. 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
[[Page 52672]]
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 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 these 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 supports 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: August 23, 2004.
Lois Rossi,
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 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 and Interregional Research Project Number 4 (IR-4)
Pesticide Petitions (PP) 0F6139, 2F6431, 3F6581, and 3E6774
EPA has received three pesticide petitions (PP 0F6139, 2F6431, and
3F6581) from BASF Corporation, Research Triangle Park, NC 27709,
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. section
346a (d), to amend 40 CFR part 180.582 by establishing tolerances 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. The following tolerances are proposed: Bean, succulent 0.5
parts per million (ppm); bean forage 1.0 ppm; bean hay 11.0 ppm; pea,
dry 0.5 ppm; pea, field, hay 26 ppm; pea, field, vines 10 ppm; corn,
field, grain 0.1 ppm; corn, field, forage 5.0 ppm; corn, field, stover
17 ppm; corn, field, aspirated grain fractions 1.5 ppm; corn, field,
refined oil 0.3 ppm); corn, pop 0.1 ppm; corn, sweet, kernel plus cob
with husk removed 0.04 ppm; corn, sweet, forage 5.0 ppm; corn, sweet,
stover 23 ppm; vegetable, legume, edible-podded, subgroup 6A 0.5 ppm;
hop 23 ppm; mango 0.1 ppm; peppermint 8.0 ppm; spearmint 8.0 ppm;
papaya 0.1 ppm; pea and bean, succulent shelled, subgroup 6B 0.2 ppm;
fruit, pome, group 1.5 ppm; apple, wet pomace 4.0 ppm; sunflower 0.3
ppm; brassica, leafy greens, subgroup 5B 16 ppm; fruit, citrus, group 2
ppm; fruit, citrus, dried pulp 12.5 ppm; citrus, oil 9 ppm; soybean
0.04 ppm; soybean, forage 5 ppm; soybean, hay 7 ppm; and soybean,
aspirated grain fractions 0.25 ppm.
EPA has also received a pesticide petition (PP 3E6774) from
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390, proposing pusuant to
section 408(d) of the FFDCA, 21 U.S.C. section 346a (d) to amend 40 CFR
part 180.582 by establishing tolerances for the combined residues of
the fungicide pyraclostrobin and its metabolite BF 500-3 in or on
vegetables, leafy, except brassica, group 4 29 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 these
petitions. Additional data may be needed before EPA rules on the
petitions. This summary has been prepared by BASF Corporation, Research
Triangle Park, NC 27709.
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 Liquid
Chromatography/Mass Spectrometry/Mass Spectrometry (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 the residue. Field trials were carried out in order
to determine the magnitude of the residue in the following crops:
Citrus (reduced Pre-harvest Interval (PHI)), field corn,
[[Page 52673]]
sweet corn, edible podded legume vegetables, hops, leafy brassica,
mango, mint, papaya, pome fruit, dry peas, soybean, succulent shelled
beans, succulent shelled peas, and sunflower. The residue trials in
mango and papaya were carried out in Latin America. Field trials for
the rest of the crops were conducted in the United States and Canada.
Field trials were carried out using the maximum label rate, the maximum
number of applications, and the minimum PHI for each crop or crop
group. In addition, processing studies were conducted on the following
crops to determine concentration factors during normal processing of
the raw agricultural commodity into the processed commodities: Corn,
mint, pome fruit, and sunflower. Magnitude of the residue trials were
previously carried out in cow and poultry and submitted with PP 0F6139.
Field trials were also carried out in order to determine the magnitude
of the residue in vegetables, leafy, except brassica, group 4 to
satisfy the requirements for a tolerance for pyraclostrobin in this
crop group. Field trials were carried out using the maximum label rate,
the maximum number of applications, and the minimum PHI.
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 registered for use on crops, an
Emulsifiable Concentrate (EC) and an Extruded Granule (EG). The EC has
an acute oral toxicity category of II, acute dermal category of III,
acute inhalation category 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 category of IV, eye
irritation category of III, skin irritation category of IV, and is not
a dermal sensitizer.
2. Genotoxicity. 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 in the bulleted list below.
Therefore, pyraclostrobin does not pose a genotoxic hazard to humans.
Ames test (one study of point mutation): Negative.
In vitro Chinese Hamster Ovary (CHO) HGPRT locus mammalian
cell mutation assay (one study of point mutation): Negative.
In vitro V79 cells CHO cytogenetic assay (one study of
chromosome damage): Negative.
In vivo mouse micronucleus (one study of chromosome
damage): Negative.
In vitro rat hepatocyte (one study of DNA damage and
repair): Negative.
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 no observable adverse effect level
(NOAEL) is the highest dose tested of 300 ppm (32.6 milligrams per
kilogram bodyweight per day (mg/kg bw/day)). Parental and pup toxicity
in the form of reduced body weight gain were observed at the highest
dose tested only. Therefore, the parental systemic and developmental
toxicity NOAELs 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 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 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 (circa (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
[[Page 52674]]
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 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 EPA final rule which published in the
Federal Register of September 27, 2002 (67 FR 60886) (FRL-7200-7). This
analysis includes all currently registered and pending crop uses, from
both IR-4 and BASF.
The acute and chronic dietary exposure estimates were based on
proposed tolerance values for most crops:
Measured residue values for vegetables, leafy, except
brassica, group 4.
Percent crop treated.
Concentration/processing factors.
Consumption data from the United States Department of
Agriculture (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,
version 2.03) software.
Results of 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 not be retained and
reduced it to 1X for all exposure scenarios. Therefore, the aPAD and
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.
The estimated chronic dietary exposure from pending crops was less than
10% of the cPAD for all subpopulations. Additional refinements such as
the use of anticipated residues would further reduce the estimated
chronic dietary exposure.
Table 1.--Chronic Dietary Exposure Assessment for Pyraclostrobin
Considering All Pending Crop Uses
------------------------------------------------------------------------
Exposure Estimate
Population Subgroups (mg/kg bw/day)\*\ %cPAD\**\
------------------------------------------------------------------------
U.S. population 0.001203 3.5
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* Exposure estimates are based on tolerance values (except measured
residue values for vegetables, leafy, except brassica, group 4),
default processing factors, and percent crop treated values.
** %cPAD = Percent of chronic Population Adjusted Dose.
As Table 2. shows, the estimated acute dietary exposure was under
the aPAD at the 99th and 99.9th percentile. The overall general U.S.
population and the most sensitive subpopulation (females 13-49 years)
utilized < 5.0% (99th percentile) and 16.1% (99.9th percentile), and <
29.3% (99th percentile) and 93.7% (99.9th percentile) of the aPAD,
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 would further
reduce the estimated acute dietary exposure.
[[Page 52675]]
Table 2.--Acute Dietary Exposure Assessment for Pyraclostrobin Considering All Pending Crop Uses
----------------------------------------------------------------------------------------------------------------
99th Percentile 99.9th Percentile
Population Subgroups Exposure Estimate 99th Percentile Exposure Estimate 99.9th Percentile
(mg/kg bw/day)\*\ %aPAD\**\ (mg/kg bw/day)\*\ %aPAD\**\
----------------------------------------------------------------------------------------------------------------
U.S. population 0.014826 4.94 0.048341 16.11
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* Exposure estimates are based on tolerance values (except measured residue values for vegetables, leafy, except
brassica, group 4); default processing factors; and percent crop treated values.
** %aPAD = Percent of acute Population Adjusted Dose.
To ensure that these additional uses on the proposed crops fit
within the total risk cup, a dietary exposure assessment (considering
tolerance values; anticipated residues for measured residue values for
vegetables, leafy, except brassica, group 4; concentration/processing
factors; and percent crop treated values) was conducted using all
currently registered and proposed crop uses (from both IR-4 and BASF)
for pyraclostrobin. This assessment also included the current tolerance
values for secondary residues in meat, meat byproducts, liver, and
milk. The maximum chronic exposure estimates remained below 25% of the
cPAD for the U.S. and all subgroup populations. The acute dietary
exposure was 6% (99th percentile) and 16.7% (99.9th percentile) of the
aPAD for the general U.S. population. For females (13-49 years), the
most sensitive subpopulation, the acute dietary exposure was 31.1%
(99th percentile) and 95.9% (99.9th percentile) of the aPAD. Additional
refinements with anticipated residues rather than tolerance values
would further reduce the estimated dietary exposures.
Results of the chronic (Table 3.) and acute (Table 4.) dietary
exposure analysis demonstrate a reasonable certainty that no harm to
the general U.S. population or any subpopulation would result from the
use of pyraclostrobin on any of the currently registered or pending
crops (both IR-4 and BASF uses).
Table 3.--Chronic Dietary Exposure Assessment for Pyraclostrobin (BAS
500 F) Considering All Crop Uses for Both Current and Pending Tolerances
------------------------------------------------------------------------
Exposure Estimate
Population Subgroups (mg/kg bw/day)\*\ %cPAD \**\
------------------------------------------------------------------------
U.S. population 0.004635 13.63
---------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------------------------
* Exposure estimates based on tolerance values for most crops;
anticipated residues for vegetables, leafy, except brassica, group 4;
actual and default concentration/processing factors; and percent crop
treated values.
** %cPAD = Percent of chronic Population Adjusted Dose.
[[Page 52676]]
Table 4.--Acute Dietary Exposure Assessment for Pyraclostrobin Considering All Crop Uses for Both Current and
Pending Tolerances
----------------------------------------------------------------------------------------------------------------
99th Percentile 99.9th Percentile
Population Subgroups Exposure Estimate 99th Percentile Exposure Estimate 99.9th Percentile
(mg/kg bw/day)\*\ %aPAD\**\ (mg/kg bw/day)\*\ %aPAD \**\
----------------------------------------------------------------------------------------------------------------
U.S. population 0.017857 5.95 0.049950 16.65
---------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* Exposure estimates based on tolerance values for most crops; anticipated residues for vegetables, leafy,
except brassica, group 4; actual and default concentration/processing factors; and percent crop treated
values.
** %aPAD = Percent of acute Population Adjusted Dose.
ii. Drinking water. There are no established maximum contaminant
levels or health advisory levels for residues of pyraclostrobin or its
metabolite in drinking water. A tier 1 drinking water modeling
assessment for pyraclostrobin using the Food Quality Protection Act
(FQPA) Index Reservoir Screening Tool (FIRST) model (for surface water)
and Screening Concentration in Groundwater (SCI-GROW) model (for
groundwater) produced estimated maximum concentrations of 20.4 parts
per billion (ppb) (acute surface water), 0.79 ppb (chronic surface
water) and 0.009 ppb (acute and chronic groundwater). These estimated
concentrations are less than Drinking Water Levels of Concern (DWLOC),
which are the worst-case calculated acceptable levels of pyraclostrobin
residues in drinking water based on acute and chronic aggregate
exposure for both registered and pending crops (see Tables 5., 6., 7.,
and 8.).
Table 5.--Pyraclostrobin Chronic Drinking Water Exposure Estimates for All Pending 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 Surface water ([mu]g/L) 0.79 0.79 0.79 0.79
SCI-GROW Groundwater ([mu]g/L) 0.009 0.009 0.009 0.009
----------------------------------------------------------------------------------------------------------------
* Drinking Water Estimated Concentrations (DECs).
[[Page 52677]]
Table 6.--Pyraclostrobin Acute Drinking Water Exposure Estimates for All Pending 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 Surface water ([mu]g/L) 20.4 20.4 20.4 20.4
SCI-GROW Groundwater ([mu]g/L) 0.009 0.009 0.009 0.009
----------------------------------------------------------------------------------------------------------------
* 99.9th percentile.
Table 7.--Pyraclostrobin Chronic Drinking Water Exposure Estimates Considering All Crop Uses for Both Current
and Pending Tolerances
----------------------------------------------------------------------------------------------------------------
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 34
------------------------------------------------------
--------------------------------------------------------------------------
---------------------------------=====================
--------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
FIRST Surface water ([mu]g/L) 0.79 0.79 0.79 0.79
SCI-GROW Groundwater ([mu]g/L) 0.009 0.009 0.009 0.009
----------------------------------------------------------------------------------------------------------------
Table 8.--Pyraclostrobin Acute Drinking Water Exposure Estimates Considering All Crop Uses for Both Current and
Pending Tolerances
----------------------------------------------------------------------------------------------------------------
Children (1-6 Infants (birth to
Acute DWLOC Adults (20-49) Females (13-49) years) 1)
----------------------------------------------------------------------------------------------------------------
No effect level 300 5 300 300
------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
---------------------------------=====================
--------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
FIRST Surface water ([mu]g/L) 20.4 20.4 20.4 20.4
[[Page 52678]]
SCI-GROW Groundwater ([mu]g/L) 0.009 0.009 0.009 0.009
----------------------------------------------------------------------------------------------------------------
* 99.9th percentile.
iii. Food plus water. The dietary exposure to pyraclostrobin
residues is summarized in tables 9. and 10.
Table 9.--Estimated Dietary Exposure to Pyraclostrobin Residues From Food and Water Considering All Pending Crop
Uses
----------------------------------------------------------------------------------------------------------------
Children (1-6 Adults (20-49 Females (13-49
Exposure Infants (0-1 years) years) years)
----------------------------------------years)------------------------------------------------------------------
Food:
Acute exposure (mg/kg bw/day)\*\ 0.170066 0.074864 0.045725 0.046863
Chronic exposure (mg/kg bw/day) 0.001291 0.002644 0.000981 0.000984
%aPAD 56.7 24.9 15.24 93.7
%cPAD 3.8 7.8 2.9 2.9
------------------------------------------------------
Acute exposure (mg/kg bw/day) 0.00204 0.00136 0.000583 0.000648
Chronic exposure (mg/kg bw/day) 0.0000009 0.000001 0 0
%aPAD 0.68 0.45 0.19 1.3
%cPAD 0 0 0 0
---------------------------------=====================
Acute exposure (mg/kg bw/day) 0.172106 0.076224 0.046308 0.047511
Chronic exposure (mg/kg bw/day) 0.0012919 0.002645 0.000981 0.000984
%aPAD 57.38 25.35 15.43 95
%cPAD 3.8 7.8 2.9 2.9
----------------------------------------------------------------------------------------------------------------
* 99.9th percentile.
Table 10.--Estimated Dietary Exposure to Pyraclostrobin Residues From Food and Water Considering all Currently
Registered and Proposed Crop Uses
----------------------------------------------------------------------------------------------------------------
Children (1-6 Females (13-49
Exposure Infants (0-1 years) Males (20-49 years)
----------------------------------------years)----------------------------------years)--------------------------
Food:
Acute exposure (mg/kg bw/day) 0.171591 0.079941 0.042017 0.047942
Chronic exposure (mg/kg bw/day) 0.003213 0.006654 0.001813 0.001781
%aPAD 57.2 26.6 14 95.9
%cPAD 9.5 19.6 5.3 5.2
------------------------------------------------------
Acute exposure (mg/kg bw/day) 0.00204 0.00136 0.000583 0.000648
Chronic exposure (mg/kg bw/day) 0.0000009 0.000001 0 0
%aPAD 0.68 0.45 0.19 1.3
%cPAD 0 0 0 0
---------------------------------=====================
Acute exposure (mg/kg bw/day) 0.173631 0.081301 0.0426 0.04859
Chronic exposure (mg/kg bw/day) 0.0032139 0.006655 0.001813 0.001781
%aPAD 57.88 27.05 14.19 97.2
%cPAD 9.5 19.6 5.3 5.2
----------------------------------------------------------------------------------------------------------------
[[Page 52679]]
These results indicate that dietary exposure to pyraclostrobin
(registered and all proposed crop uses), from potential residues in
food and water, will not exceed EPA's level of concern (100% of aPAD or
cPAD). 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) of the FFDCA 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 500 F inhibits spore
germination, germ tube growth, and penetration into the host tissues.
EPA is currently developing methodology to perform cumulative risk
assessments. At this time, there are no available data to determine
whether BAS 500 F 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 that is
also produced by other pesticides.
E. Safety Determination
1. U.S. population. Adding the proposed uses to those crops that
are already on the pyraclostrobin label resulted in aggregate exposure
of adults in the U.S. population to pyraclostrobin that 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 crop uses.
2. Infants and children. All subpopulations based on age were
considered. The highest potential exposure was predicted for the
subgroup children (1-6 years old). 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 89% of the cPAD for
children (1-6 years old). BASF therefore 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 crop uses.
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. 04-19627 Filed 8-26-04; 8:45 am]
BILLING CODE 6560-50-S