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http://www.epa.gov/fedrgstr/EPA-PEST/2003/March/Day-07/p5319.htm
[Federal Register: March 7, 2003 (Volume 68, Number 45)]
[Notices]
[Page 11096-11100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr03-78]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0011; FRL-7290-1]
Sulfentrazone; Notice of Filing Pesticide Petitions to Establish
Tolerances 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-2003-0011, must be
received on or before April 7, 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:
brothers.shaja@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
[[Page 11097]]
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in insert appropriate
cite to either another unit in the preamble or a section in a rule. If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0011. 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 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-2003-0011 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-2003-0011. In contrast to EPA's
[[Page 11098]]
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-2003-0011.
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-2003-0011. 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 pesticide petitions 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
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 support granting of
these 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:January 30, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
The petitioner's summaries of the pesticide petitions is printed
below as required by FFDCA section 408(d)(3). The summaries of the
petitions was prepared by FMC Corporation and represents the view of
FMC Corporation. The petitions summaries 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 and FMC Corporation
PP (0E6149, 1E6311, 2E6405, 2E6498, 2E6500, 0F6116, and 2F6391
EPA has received pesticide petitions (0E6149, 1E6311, 2E6405,
2E6498, and 2E6500) from Interregional Research Project Number (IR-4),
681 U.S. Highway #1 South, North Brunswick, NJ 08902. EPA has
also received pesticide petitions (0F6116 and 2F6391) from FMC
Corporation, Agricultural Products Group, 1735 Market Street,
Philadelphia, PA 19103 proposing, pursuant to section 408(d) of the
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.498 by establishing
tolerances for residues of sulfentrazone (N-2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl-methanesulfonamide) and its metabolites 3-hydroxymethyl-
sulfentrazone (N-2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide)
and 3-desmethyl sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) in
or on the following raw agricultural commodities:
1. PP 0E6149 proposes the establishment of a tolerance for
sunflower, seed at 0.2 parts per million (ppm).
2. PP 1E6311 proposes the establishment of tolerances for
horseradish, roots at 0.2 ppm, cabbage at 0.2 ppm, peppermint, tops at
0.3 ppm, and spearmint, tops at 0.3 ppm.
3. PP 2E6405 proposes the establishment of a tolerance for potato
at 0.1 ppm.
4. PP 2E6498 proposes the establishment of a tolerance for bean,
lima, succulent at 0.15 ppm.
5. PP 2E6500 proposes the establishment of a tolerance for
asparagus at 0.15 ppm.
6. PP 0F6116 proposes the establishment of tolerances for peanut
nutmeat and its processed parts at 0.2 ppm, and sugarcane and its
processed parts at 0.1 ppm.
7. PP 2F6391 proposes the establishment of tolerances for corn,
field, forage at 0.25 ppm, corn, field,
[[Page 11099]]
stover at 0.35 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C at 0.15 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 notice includes summaries of the petitions prepared by
FMC Corporation, Philadelphia, PA 19103.
A. Residue Chemistry
1. Plant metabolism. The metabolism of sulfentrazone in plants is
adequately understood for the existing and proposed tolerances.
2. Analytical method. The proposed analytical method for
determining residues of sulfentrazone is hydrolysis followed by gas
chromatographic separation.
3. Magnitude of residues. The magnitude of residues is adequately
understood for the proposed commodities.
B. Toxicological Profile
1. Acute toxicity. A battery of acute toxicity studies placed
technical sulfentrazone in toxicity categories III and IV. No evidence
of sensitization was observed following dermal application in guinea
pigs. In an acute neurotoxicity study in rats at gavage doses of 0,
750, or 2,000 milligrams/kilogram (mg/kg), the no observable adverse
effect level (NOAEL) of 250 mg/kg and the lowest observable adverse
effect level (LOAEL) of 750 mg/kg were based upon increased incidences
of clinical signs, Functional Observation Battery (FOB) findings, and
decreased motor activity which were reversed by day 14 post-dose. There
was no evidence of neuropathology.
2. Genotoxicity. A reverse gene mutation assay (salmonella
typhimurium) yielded negative results, both with and without metabolic
activation. A mouse lymphoma forward gene mutation assay yielded
negative results with equivocal results without activation. A mouse
micronucleus assay test was negative following intraperitoneal
injection of 340 mg/kg.
3. Reproductive and developmental toxicity. In a dermal
developmental study in the rat at doses of 0, 5, 25, 50, 100, and 250
mg/kg/day, a maternal (systemic) NOAEL was established at 250 mg/kg/
day. Significant treatment-related increases in the fetal and litter
incidences of incompletely ossified lumbar vertebral arches,
hypoplastic or wavy ribs, and incompletely ossified or nonossified
ischia or pubes occurred at the high-dose (250 mg/kg/day). An
additional significant increase in the high-dose fetal incidence of
variations in the sternebrae (incompletely ossified or unossified) was
not judged to be treatment-related. At 250 mg/kg/day, the mean numbers
of thoracic vertebral and rib ossification sites were significantly
decreased, a high-dose effect of treatment with sulfentrazone
consistent with the significant treatment-related hypoplasia observed
in the skeletal evaluation of the ribs. Therefore, the developmental
(fetal) LOAEL is 250 mg/kg/day based on decreased fetal body weight;
increased incidences of fetal variations: Hypoplastic or wavy ribs,
incompletely ossified lumbar vertebral arches, and incompletely
ossified ischia or pubes; and reduced number of thoracic vertebral and
rib ossification sites. The developmental (fetal) NOAEL is 100 mg/kg/
day.
A developmental toxicity study in rabbits was conducted at gavage
dose levels of 0, 100, 250, or 375 mg/kg/day. Treatment-related
incidences of decreased feces and hematuria were noted at 250 mg/kg/day
or greater. In addition, at the 375 mg/kg/day dose level, 5 rabbits
aborted. Significant reductions in mean body weight change were
observed for the dosing period (GD 7-19) and for the study duration (GD
0-29, both before and after adjustment for gravid uterine weight) at
the 250 and 375 mg/kg/day dose levels. Therefore, the maternal
(systemic) LOAEL is 250 mg/kg/day, based upon increased abortions,
clinical signs (hematuria and decreased feces), and reduced body weight
gain. The maternal (systemic) NOAEL is 100 mg/kg/day. Skeletal
evaluation in fetuses revealed dose-related and treatment-related
findings at the 375 mg/kg/day dose level. These included significant
increases in both the fetal and litter incidences of fused caudal
vertebrae (a malformation) and of partially fused nasal bones (a
variation). In addition, at 375 mg/kg/day, significant treatment-
related reductions in ossification site averages were observed for
metacarpals and both forepaw and hindpaw phalanges. Therefore, the
developmental (fetal) LOAEL is 250 mg/kg/day, based upon increased
resorptions, decreased live fetuses per litter, and decreased fetal
weight. The developmental (fetal) NOAEL is 100 mg/kg/day.
A 2-generation reproduction study in the rat at dietary levels of
14, 33, or 46 mg/kg/day in males and 16, 40, or 56 mg/kg/day in females
established a NOAEL for systemic and reproductive/developmental
parameters of 14 mg/kg/day for males and 16 mg/kg/day for females. The
LOAEL for systemic and reproductive/development parameters was 33 mg/
kg/day for males and 40 mg/kg/day for females. Systemic effects were
comprised of decreased body weight gains, while reproductive/
developmental effect at the LOAEL included degeneration and/or atrophy
in the testes, with epididymal sperm deficits, in the second (F1)
generation males. Male fertility in the F1 generation was reduced at
higher doses; litter size, pup survival, and pup body weight for both
generations were also effected at higher doses.
4. Subchronic toxicity. A 90-day subchronic toxicity study was
conducted in rats, with dietary intake levels of 0, 3.3, 6.7, 19.9,
65.8, 199.3, or 534.9 mg/kg/day for males and 0, 4, 7.7, 23.1, 78.1,
230.5, or 404.3 mg/kg/day for females respectively. NOAELs of 19.9 mg/
kg/day in males and 23.1 mg/kg/day in females were based on clinical
anemia.
A 90-day subchronic feeding study was conducted in mice by dietary
admix at doses of 0, 10.3, 17.8, 60.0, 108.4, or 194.4 mg/kg/day for
males and 0, 13.9, 29.0, 79.8, 143.6, or 257.0 mg/kg/day for females,
respectively. NOAELs of 60 mg/kg/day (males) and 79.8 mg/kg/day
(females) were based on decreases in body weights and/or gains;
decreased erythrocytes, hemoglobin (Hgb) and hematocrit (HCT) values;
and splenic microscopic pathology.
In a 90-day subchronic feeding study in dogs administered by
dietary admix at doses of 0, 10, 28, or 57 mg/kg/day for males and 0,
10, 28, or 73 mg/kg/day for females, a NOAEL of 28 mg/kg/day was
determined for both males and females based on decreases in Hgb and
HCT, elevated alkaline phosphatase levels, increased liver weights and
microscopic liver as well as splenic changes.
A 90-day subchronic neurotoxicity study in the rat was conducted at
dietary levels of 30, 150, or 265 mg/kg/day in males, and 37, 180, or
292 mg/kg/day in females, with a NOAEL of 30 mg/kg/day in males and 37
mg/kg/day in females. The LOAEL was 150 mg/kg/day for males and 180 mg/
kg/day for females based on increased incidences of clinical signs,
decreased body weights, body weight gains, and food consumption in
females and increased motor activity in females at week 13. There were
no neurohistopathological effects on the peripheral or central nervous
system.
5. Chronic toxicity. A 12-month feeding study in dogs was dosed at
levels of 0.0, 24.9, or 61.2 mg/kg/day for male dogs and 0.0, 10.4,
29.6, or 61.9
[[Page 11100]]
mg/kg/day for female dogs in the control through high-dose groups,
respectively, with a NOAEL of 24.9 mg/kg/day for males and 29.6 mg/kg/
day for females based on hematology effects and microscopic liver
changes.
An 18-month feeding/carcinogenicity study in mice was conducted
with dietary intake of 0, 46.6, 93.9, 160.5, or 337.6 mg/kg/day for
males and 0, 58.0, 116.9, 198.0, or 407.1 mg/kg/day for females. A
NOAEL of 93.9 mg/kg/day in males and 116.9 mg/kg/day in females was
based on decreases in Hgb and HCT. There were no treatment-related
increases in tumors of any kind observed at any dose level.
In a 24-month chronic feeding/carcinogenicity study in rats at
dietary doses of 0, 24.3, 40.0, 82.8, or 123.5 mg/kg/day for males and
20.0, 36.4, 67.0, or 124.7 mg/kg/day for females, an overall NOAEL of
40.0 mg/kg/day in males and 36.4 mg/kg/day in females was based on
hematology effects and reduced body weights. There was no evidence of a
carcinogenic response.
6. Animal metabolism. A metabolism study in rats indicated that
approximately 84 to 104% of the orally administered dose of
sulfentrazone was excreted in the urine, and that the pooled urinary
radioactivity consisted almost entirely of 3-hydroxymethyl
sulfentrazone. Pooled fecal radioactivity showed that the major
metabolite consisted of 3-hydroxymethyl-sulfentrazone (1.26 to 2.55% of
the administered dose). The proposed metabolic pathway appeared to be
conversion of the parent compound mainly to 3-hydroxymethyl-
sulfentrazone (excreted in urine and feces).
7. Endocrine disruption. An evaluation of the potential effects on
the endocrine systems of mammals has not been determined; however, no
evidence of such effects were reported in the chronic or reproductive
toxicology studies described above. There was no observed pathology of
the endocrine organs in these studies. There is no evidence at this
time that sulfentrazone causes endocrine effects.
C. Aggregate Exposure
1. Dietary exposure--i. Food. A Tier 3 short-term exposure analysis
has been performed to estimate the exposure for all adults, adult
females, and toddlers (3 to 4 years of age) in the U.S. population for
these raw commodities and processed commodities. This analysis utilized
Novigen's (Novigen Sciences, Inc.) Dietary Exposure Evaluation Model
(DEEM) software; field trial data for registered and pending crop uses;
percent crop treated information; and consumption data from the United
States Department of Agriculture (USDA) Continuing Surveys of Food
Intake by Individuals (CSFIIs), conducted from 1994-1996.
ii. Drinking water. A Tier 1 short-term drinking water exposure
assessment was conducted to determine exposure risk of sulfentrazone
residues from consumption of water. This analysis was performed
utilizing EPA's Standard Operating Procedure (SOP) for Drinking Water
Exposure Risk Assessments (DUS EPA, 1997b), the absorbed (systemic)
aggregate exposure estimates, and water data from FMC Corporation
ground water study conducted in North Carolina.
2. Non-dietary exposure. The primary source for human non-dietary
exposure to sulfentrazone will be from post-application exposure to
treated residential turf grass. The routes of sulfentrazone exposure
were dermal post-application exposure for adults and toddlers, and
post-application incidental ingestion of sulfentrazone due to the hand-
to-mouth behavior of toddlers. A worst case short-term non-dietary
exposure analysis was conducted using algorithms and default factors
published in EPA's SOPs for Residential Exposure Assessments.
D. Cumulative Effects
Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
considers ``available information'' concerning the cumulative effects
of a particular pesticide residue and ``other substances that have a
common mechanism of toxicity.''
In the case of sulfentrazone, EPA has determined that it does not
have the capability to apply the information in its files to a
resolution of common mechanism issues in a manner that would be useful
in a risk assessment. This tolerance determination therefore does not
take into account common mechanism issues. The Agency will reexamine
the tolerances for sulfentrazone, if reexamination is appropriate,
after the Agency has determined how to apply common mechanism issues to
its pesticide risk assessments.
E. Safety Determination
1. U.S. population. The absorbed (systemic) aggregate exposure
estimates for all adults, and adult females were found to be 0.0015 mg/
kg/day and 0.0017 mg/kg/day, respectively. The acute dietary (99.9%),
non-dietary, and aggregate margin of exposure (MOE) for all adults were
found to be 12,353, 7,571, and 6,726 respectively. The acute dietary
(99.9%), non-dietary and aggregate MOE for adult females were 22,857,
6,327, and 5,717 respectively. The MOE from the limited potential for
short-term exposure from residential uses was >1,000. Based on these
assessments, it can be concluded that there is reasonable certainty of
no harm to the U.S. population from exposure to sulfentrazone.
2. Infants and children. The absorbed (systemic) aggregate exposure
estimates for toddlers were found to be 0.0054 mg/kg/day. The acute
dietary (99.9%), non-dietary, and aggregate MOE for toddlers were found
to be 6,721, 2,048, and 1,869 respectively. The MOE from the limited
potential for short-term exposure from residential uses was >1,000.
Based on these assessments, it can be concluded that there is
reasonable certainty of no harm to infants and children from exposure
to sulfentrazone.
The calculated drinking water levels of concern for all adults, and
adult females were estimated to be 298 parts per billion (ppb), 250
ppb, respectively. These values exceed the maximum water-monitoring
residue of 42 ppb (from the North Carolina study). Therefore, the data
indicate a low risk potential due to the aggregate (food, water and
residential) exposures to sulfentrazone residues.
F. International Tolerances
There are no Codex Alimentarius Commission (Codex) maximum residue
levels for sulfentrazone.
[FR Doc. 03-5319 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S