[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11096-11100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5319]


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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: 
[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

[[Page 11097]]

producer, food manufacturer, or pesticide manufacturer. Potentially 
affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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 [email protected], 
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