[Federal Register Volume 68, Number 10 (Wednesday, January 15, 2003)]
[Notices]
[Pages 2032-2036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-850]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0356; FRL-7286-4]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket ID number OPP-2002-0356, must be 
received on or before February 14, 2003.

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 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 identification (ID) number OPP-2002-0356. 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

[[Page 2033]]

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-2002-0356. 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-2002-0356. 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-2002-0356.
    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-2002-0356. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

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

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

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

II. What Action is the Agency Taking?

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

List of Subjects

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

    Dated: December 20, 2002.
 Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as

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required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Interregional Research Project Number (IR-4) and Crompton Manufacturing 
Company, Inc.

PP 3E6517

    EPA has received a pesticide petition (3E6517) from the 
Interregional Research Project Number (IR-4), 681 U.S. Hwy. 1 
South, North Brunswick, NJ 08902 proposing, pursuant to section 408(d) 
of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.572 by 
establishing tolerances for residues of bifenazate, (diazinecarboxylic 
acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl),1-methylethylester) in or on 
the following raw agricultural commodities (RACs): Vegetable, cucurbit, 
group at 0.6 part per million (ppm); vegetable, fruiting, group at 2.0 
ppm; peppermint, tops at 25 ppm; spearmint, tops at 25 ppm; nut, tree, 
group at 0.2 ppm; almond, hulls at 10 ppm; okra at 2.0 ppm; and 
pistachio at 0.2 ppm. EPA has determined that the petition contains 
data or information regarding the elements set forth in section 
408(d)(2) of the FFDCA; however, EPA has not fully evaluated the 
sufficiency of the submitted data at this time or whether the data 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition. This notice includes a summary of the 
petition prepared by Crompton Manufacturing Company, Inc. (formerly 
Uniroyal Chemical Company), Middlebury, CT 06749.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residues of bifenazate in 
plants is adequately understood. The major residue in all plant 
metabolism studies is bifenazate. A minor, but significant metabolite 
is the diazene D3598, which was found to interconvert readily to/from 
bifenazate in the plant matrix during the analytical procedure.
    2. Analytical method. Crompton has developed practical analytical 
methodology for detecting and measuring residues of bifenazate in or on 
RACs. As D3598, a significant metabolite, was found to interconvert 
readily to/from bifenazate, the analytical method was designed to 
convert all residues of D3598 to the parent compound (bifenazate) for 
analysis. The method utilizes reversed phase high performance liquid 
chromotography (HPLC) to separate the bifenazate from matrix derived 
interferences, and oxidative coulometric electrochemical detection for 
the identification and quantification of this analyte.

B. Toxicological Profile

    1. Acute toxicity. Bifenazate technical, acramite-50WS, and 
floramite SC have low acute oral, dermal, and inhalation toxicity in 
laboratory animals. The oral lethal dose LD50 in rats and 
mice is greater than 5 grams/kilogram (g/kg) for acramite-50WS and the 
technical material. The oral LD50 of floramite SC is greater 
than 5 g/kg in males and greater than 2 g/kg in females. The dermal 
LD50 in rats of bifenazate technical and both formulations 
is greater than 5 g/kg. The inhalation lethal concentration 
LC50 in the rats of bifenazate technical, acramite-50WS and 
floramite SC was found to be greater than 4.4, 5.2, and 1.8 milligrams/
liter (mg/L), respectively. In eye irritation studies, acramite-50WS 
was a slight irritant, and bifenazate technical was non-irritating. 
Floramite SC was found to be irritating to the eyes. All 3 products 
were found to be non-irritating to the skin of rabbits and non-
sensitizing on the skin of guinea pigs.
    2. Genotoxicity. Bifenazate was evaluated and found to be negative 
in the Ames Reverse Mutation, Mouse Lymphoma, chinese hamster ovary 
(CHO) chromosome aberration and mouse micronucleus assays.
    3. Reproductive and developmental toxicity--i. Rabbit developmental 
study. A range-finding study conducted in pregnant New Zealand white 
rabbits at dosage levels of 125, 250, 500, 750, and 1,000 milligrams/
kilogram/day (mg/kg/day) demonstrated maternal toxicity at dosage 
levels of 500 mg/kg/day and greater and abortions at dosage levels of 
250 mg/kg/day and greater. Bifenazate was then administered by oral 
gavage to pregnant New Zealand white rabbits at dosage levels of 10, 
50, and 200 mg/kg/day. No test article related effects were seen at any 
dose level. The no observable adverse effect level (NOAEL) for maternal 
and developmental toxicity was greater than 200 mg/kg/day.
    ii. Rat developmental study. Bifenazate did not produce 
developmental toxicity when administered by oral gavage to pregnant 
Sprague-Dawley CD rats at dosage levels of 10, 100, and 500 mg/kg/day. 
A reduction in maternal body weight gain was seen at dosage levels of 
100 and 500 mg/kg/day. Clinical observations at 500 mg/kg/day included 
red material/staining on body surfaces, pale extremities, and brown 
discharge. No developmental or teratogenic effects were observed at any 
dosage level. The NOAEL for maternal toxicity was 10 mg/kg/day and the 
NOAEL for developmental toxicity was greater than 500 mg/kg/day.
    iii. Rat reproduction study. Bifenazate showed no effects on 
reproduction when fed to 2-generations of male and female Sprague-
Dawley CD rats at dietary concentrations of 20, 80, and 200 ppm. At a 
dosage level of 200 ppm there was a reduction in body weight gain in F0 
males and females. Food consumption was unaffected. There was a 
reduction in body weight gain in F1 females at all dosage levels and in 
F1 males at 80 and 200 ppm in the absence of effects on food 
consumption. Since the 20 ppm F1 males did not have a significant 
reduction in body weight gain, this dosage level can be considered a 
NOAEL for systemic adult toxicity. The reduction in body weight gain in 
the F1 females at 20 ppm would not be considered biologically 
significant because no effects were observed on reproductive parameters 
or in the F2 litter. The reproductive and developmental NOAEL was 
greater than 200 ppm (10 mg/kg/day).
    4. Subchronic toxicity--i. Thirteen-week rat feeding study. 
Bifenazate was fed to male and female Sprague Dawley CD rats for 13 
weeks at dietary concentrations of 40, 200, and 400 ppm. At dosage 
levels of 200 and 400 ppm there was a reduction in red blood cell (RBC) 
count and hemoglobin (Hgb). Food intake was reduced for 200 ppm females 
and 200 and 400 ppm males. Histopathological effects were seen in the 
liver, spleen, and adrenal cortex in males and females at 200 and/or 
400 pm. The maximum tolerated dose (MTD) was exceeded in females at 200 
ppm and in males and females at 400 ppm. The NOAEL for subchronic 
toxicity in rats was 40 ppm (2 mg/kg/day).
    ii. Neurotoxicity assessment. No treatment related effects were 
seen on neuro-behavior in a Standard Functional Observation Battery 
conducted at weeks 8 and 13 of the rat feeding study. No overt signs of 
anti-cholinergic activity, and no statistically significant effects on 
cholinesterase (ChE) activity were seen in rats in a 2-week feeding 
study at dose levels up to 400 ppm. Plasma, erythrocyte and brain ChE 
activity were evaluated in male and female rats fed bifenazate-treated 
diet at 0, 20, 200, or 400 ppm for 2 weeks. All animals survived until 
study termination and effects were only seen on body weight gain and 
food

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consumption. The NOAEL for cholinergic inhibition was greater than 400 
ppm (20 mg/kg/day).
    iii. Thirteen-week dog feeding study. Bifenazate was fed to male 
and female Beagle dogs for 13 weeks at dietary concentrations of 40, 
400, and 1,000 ppm. At dosage levels of 400 and 1,000 ppm there was a 
reduction in RBC count, Hgb and hematocrit (HCT). Liver weights were 
increased at 400 and 1,000 ppm and centrilobular hepatocellular 
hypertrophy was seen in females at 400 ppm and males and females at 
1,000 ppm. The NOAEL for subchronic toxicity in dogs was 40 ppm (1 mg/
kg/day).
    5. Chronic toxicity--i. Dog chronic feeding study. Bifenazate was 
fed to male and female Beagle dogs for 1-year at dietary concentrations 
of 40, 400, and 1,000 ppm. At dose levels of 400 and 1,000 ppm, there 
was a reduction in food consumption in males and reduced body weight 
gain in males and females. There was a reduction in RBC count, Hgb, and 
HCT and an increase in bilirubin at 400 and 1,000 ppm. 
Histopathological effects on bone marrow, kidney, and liver were also 
seen at these dose levels. The NOAEL for chronic toxicity in dogs was 
40 ppm (1 mg/kg/day).
    ii. Rat chronic feeding/carcinogenicity study. Bifenazate was not 
carcinogenic in rats when fed to male and female Sprague-Dawley CD rats 
for 2 years at dietary concentrations of 20, 80, and 160 in females or 
20, 80, and 200 ppm in males. Body weight gain was reduced in males and 
females at the high dosage levels. A reduction in RBC count and an 
increase in splenic pigment were seen in females at 160 ppm, while high 
dose males exhibited a reduction in total cholesterol and an increase 
in splenic pigment. At a dose level of 80 ppm there was a reduction in 
body weight gain, a decrease in RBC count and an increase in splenic 
pigment in females. There was no increase in tumor incidence in males 
or females as a result of bifenazate administration. The NOAEL for 
chronic toxicity in rats was 20 ppm (1 mg/kg/day).
    iii. Mouse carcinogenicity study. Bifenazate was not carcinogenic 
when fed to male and female CD-1 mice for 18 months at dietary 
concentrations of 10, 100, and 175 ppm in females and 10, 100, and 225 
ppm in males. Body weight gain was reduced in males and females at the 
high dose level. A reduction in RBC, total leukocyte and lymphocyte 
counts was seen in males at 225 ppm. There was no increase in tumor 
incidence in males or females as a result of bifenazate administration.
    6. Animal metabolism. In rat, \14\C-bifenazate, \14\C-phenyl 
hydrazine carboxylic acid, 2-(4-methoxy-1,1-biphenyl-3-yl)-1-
methylethyl ester was extensively metabolized when it was given orally 
in 2 dose levels low (10 mg/kg), and high (1,000 mg/kg). Although 
1/89/21/13/25/87/83/8 of the dosed radioactivity was excreted 
in the feces, bifenazate depicted a good degree of absorption as 
indicated from the level of radioactivity in the bile. In the bile 
radioactivity study, about 70% of the C-14 was collected from the 
cannulated bile ducts of low dosed rats indicating an active level of 
absorption and enterohepatic circulation.
    7. Metabolite toxicology. In a single dose oral toxicity limit test 
in rats, the oral LD50 of the diazene product of bifenazate 
was estimated to be approximately 5,000 mg/kg. At 2 hours and at 7 days 
post-dosing, no effects were seen on erythrocyte cholinesterase 
inhibition (ChEI) in male or female rats. In addition, no effect on 
plasma ChEI was seen in male rats at 7 days only. Since this effect was 
seen only in plasma of females at one time point, it is most likely a 
pseudo-cholinesterase effect without biological significance. In a 
dermal toxicity screen, the LD50 of the diazene was 
estimated to be >2,000 mg/kg.
    8. Endocrine disruption. There are no known reported adverse 
reproductive or developmental effects in domestic animals or wildlife 
as a result of exposure to this chemical. A standard battery of 
required toxicity tests have been conducted on bifenazate. No effects 
were seen in the reproduction or developmental studies to indicate that 
bifenazate has an effect on the endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Based on dietary, drinking water, and non-
occupational exposure assessments, there is reasonable certainty of no 
harm to the U.S. population, any population subgroup, or infants and 
children from chronic exposure to bifenazate.
    i. Food. Chronic dietary exposure was estimated using dietary 
exposure evaluation model DEEM\TM\ tolerance levels, and 100% crop 
treated. Processing factors were used for apple and grape juice. The 
chronic dietary exposure to the U.S. population (total) was estimated 
as 0.003093 mg/kg bwt/day, and was 30.9% of the reference dose (RfD). 
Exposure to non-nursing infants, the highest exposed population 
subgroup, was 0.007238 mg/kg bwt/day (72.4% of the RfD), and exposure 
to children was 0.006627 mg/kg bwt/day (66.3% of the RfD).
    ii. Drinking water. The residue of concern in drinking water was 
determined to be D1989. Chronic estimated environmental concentrations 
(EECs) of D1989 in surface water and ground water were generated using 
FIRST and the screening concentration in ground water (SCI-GROW) (1 
application at 0.75 lbs active ingredient/acre). The FIRST model 
generated an EEC of 0.114 part per billion (ppb), whereas, the SCI-GROW 
model generated an EEC of 0.0119 ppb. These EEC values are much lower 
than the drinking water levels of concern (LOC) (227 ppb for adults, 
27.6 ppb for infants and children). Therefore, exposure to potential 
residues in drinking water is expected to be negligible.
    2. Non-dietary exposure. Food uses described in this petition are 
strictly agricultural, and will not add to any residential non-dietary 
exposure that may exist.

D. Cumulative Effects

    The mechanism/mode of action of bifenazate on the mammalian RBC, 
which is the target organ in the species tested, remains to be 
elucidated. The lack of information on bifenazate mode of action 
precludes an assessment of cumulative effects.

E. Safety Determination

    1. U.S. population. Based on the toxicology data base and available 
information on anticipated residues, chronic dietary exposure to the 
U.S. population (total) was 30.9% of the RfD. Exposure to potential 
residues in drinking water is expected to be negligible, as drinking 
water levels of concern (DWLOCs) are substantially higher than modeled 
acute and long-term EECs. The margin of exposure (MOEs) 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 or any 
population subgroup from exposure to bifenazate.
    2. Infants and children. The chronic dietary exposure was 72.4% of 
the RfD for infants, and 66.3% for children. Exposure to potential 
residues in drinking water is expected to be negligible, as DWLOCs are 
substantially higher than modeled acute and long-term EECs. The MOEs 
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 bifenazate.

[[Page 2036]]

F. International Tolerances

    There are no Codex or other international maxium residue levels 
(MRLs) on tolerances for the requested uses with the exception of 
cherries in Japan. In Japan, the following MRLs have been established: 
Citrus 0.2 and 1.0; apple 2.0; pear 2.0; peach 0.2; cherry 3.0; 
strawberry 3.0; watermelon 0.2; and tea 2.0. There are no other current 
MRLs or tolerances for bifenazate.
[FR Doc. 03-850 Filed 1-14-03; 8:45 am]
BILLING CODE 6560-50-S