[Federal Register Volume 69, Number 166 (Friday, August 27, 2004)]
[Notices]
[Pages 52684-52688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19614]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0270]; FRL-7675-2]


Fenhexamid; 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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0270, 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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. 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. Other types of 
entities not listed in this unit could also be affected. 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-2004-0270. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/

[[Page 52685]]

 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-2004-0270. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0270 . 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- 2004-0270.
    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 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0270. 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

[[Page 52686]]

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), 21U.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: August 20, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as 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 4

PP 3E6799

    EPA has received a pesticide petition (PP 3E6799) from the IR-4 
Project, Center for Minor Crop Pest Management, Technology Centre of 
New Jersey. Rutgers, the State University of New Jersey, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to 
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.553 
by establishing tolerances for residues of the fungicide, fenhexamid, 
(N-2,3-dichloro-4-hydroxypheny)-1-methyl cyclohexanecarboxamide), in or 
on the raw agricultural commodity fruit, pome, group 11 pre- and post-
harvest at 10.0 parts per million (ppm) and apple, wet pomace at 25 
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 supports granting of the 
petition. Additional data may be needed before EPA rules on the 
petition. The petition summary was prepared by the registrant, Arvesta 
Corporation, 100 First Street, San Francisco, CA 94106.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of fenhexamid residues 
in plants is adequately understood.
    2. Analytical method. An adequate method for purposes of 
enforcement of the proposed fenhexamid tolerances in plant commodities 
is available.
    3. Magnitude of residues. The magnitude of residues for fenhexamid 
on the proposed commodities is adequately understood.

B. Toxicological Profile

    1. Acute toxicity. The acute oral toxicity study resulted in a 
lethal dose (LD50) of > 5,000 milligrams/kilogram(mg/kg) for 
both sexes. The acute dermal toxicity in rats resulted in an 
LD50 of > 5,000 mg/kg for both sexes. The acute inhalation 
was investigated in two studies in rats. Inhalation by aerosol at the 
maximum technically possible concentration of 0.322 mg/liter(L) 
resulted in no deaths or symptoms at lethal concentration 
(LC)50 > 0.322 mg/L). A dust inhalation study resulted in a 
LC50 > 5.057 mg/L. Fenhexamid was not irritating to the skin 
or eyes after a 4-hour exposure period. The Buehler dermal 
sensitization study in guinea pigs indicated that fenhexamid is not a 
sensitizer. Based on these results fenhexamid technical is placed in 
toxicity Category IV and Arvesta concludes that fenhexamid does not 
pose any acute dietary risks.
    2. Genotoxicity. The potential for genetic toxicity of fenhexamid 
was evaluated in six assays including two Ames tests, a HGPRT forward 
mutation assay, an unscheduled DNA synthesis (UDS) assay, an in vitro 
chromosomal aberration assay in Chinese hamster ovary (CHO) cells, and 
a micronucleus test in mice. The compound was found to be devoid of any 
mutagenic activity in each of these assays; including those tests that 
investigated the absence or presence of metabolic activating systems. 
Arvesta believes the weight of evidence indicates that fenhexamid 
technical does not pose a risk of mutagenicity or genotoxicity.
    3. Reproductive and developmental toxicity.--i. In a 2-generation 
reproduction study (one mating per generation), 30 Sprague-Dawley rats 
per sex per dose were administered 0, 100, 500, 5,000, or 20,000 ppm of 
fenhexamid in the diet. The reproductive toxicity no observed adverse 
effect level (NOAEL) was 20,000 ppm. The neonatal NOAEL was 500 ppm, 
and the lowest observed adverse effect level (LOAEL) was 5,000 ppm 
based on decreased pup body weight. The parental toxicity NOAEL was 500 
ppm based on lower adult pre-mating body weights at 5,000 and 20,000 
ppm, lower gestation body weights at 20,000 ppm, lower lactation body 
weights at 5,000 and 20,000 ppm, and statistically significant changes 
in clinical chemistry parameters, terminal body weights, and organ 
weights at 5,000 and 20,000 ppm. Based on this study, Arvesta concludes 
that the only toxic effects in the neonates occurred at parentally 
toxic doses.
    ii. In rats, fenhexamid was administered by gavage at doses of 0 or 
1,000 mg/kg for gestation days 6-15. No maternal toxicity, 
embryotoxicity, fetotoxicity, or teratogenic effects were observed at 
the limit dose of 1,000 mg/kg/day. Therefore, the NOAEL for maternal 
and developmental toxicity was 1,000 mg/kg/day.
    iii. In rabbits, fenhexamid was administered by gavage at doses of 
0,

[[Page 52687]]

100, 300, and 1,000 mg/kg for gestation days 6-18. Body weight gain and 
feed consumption of the dams were reduced at the two top doses. One 
abortion occurred in each of the top two dose groups and two total 
resorptions occurred in the top dose group. The placental weights were 
slightly decreased at 300 mg/kg/day and above. In the 1,000 mg/kg/day 
group, slightly decreased fetal weights and a slightly retarded 
skeletal ossification were observed. All other parameters investigated 
in the study were unaffected. Therefore, the NOAELs for maternal and 
developmental toxicity were 100 mg/kg/day in this study.
    Based on the 2-generation reproduction study in rats, Arvesta 
concludes that fenhexamid should not be considered a reproductive 
toxicant and shows no evidence of endocrine effects. The data from the 
developmental toxicity studies on fenhexamid show no evidence of a 
potential for developmental effects (malformations or variations) at 
doses that are not maternally toxic. The NOAEL for both maternal and 
developmental toxicity in rats was 1,000 mg/kg/day, and for rabbits the 
NOAEL for both maternal and developmental toxicity was 100 mg/kg/day.
    4. Subchronic toxicity.--i. Fenhexamid was administered in the diet 
to rats for 13 weeks at doses of 0, 2,500, 5,000, 10,000, and 20,000 
ppm. The NOAEL was 5,000 ppm (415 mg/kg/day in males and 549 mg/kg/day 
in females). Reversible liver effects were observed at 10,000 ppm.
    ii. Fenhexamid was administered in the diet to mice for 
approximately 14 weeks at doses of 0, 100, 1,000, and 10,000 ppm. The 
NOAEL was 1,000 ppm (266.6 mg/kg/day in males and 453.9 mg/kg/day in 
females). Increased feed and water consumption and kidney and liver 
effects were observed at 10,000 ppm.
    iii. Fenhexamid was administered in the diet to beagle dogs for 13 
weeks at doses of 0, 1,000, 7,000, and 50,000 ppm. The NOAEL was 1,000 
ppm (33.9 mg/kg/day in males and 37.0 mg/kg/day in females). Increased 
Heinz bodies were observed at 7,000 ppm. .
    5. Chronic toxicity--i. Fenhexamid was administered in the feed at 
doses of 0, 500, 3,500, or 25,000 ppm to 4 male and 4 female beagle 
dogs per group for 52 weeks. A systemic NOAEL of 500 ppm (an average 
dose of 17.4 mg/kg/day over the course of the study) was observed based 
on decreased food consumption and decreased body weight gain at 25,000 
ppm, decreased erythrocyte, hemoglobin and hematocrit values at 25,000 
ppm, increased Heinz bodies at 3,500 ppm and above, and a dose-
dependent increase of alkaline phosphatase at 3,500 ppm and above. 
There were no treatment related effects on either macroscopic or 
histologic pathology.
     ii. A combined chronic/oncogenicity study was performed in Wistar 
rats. Fifty animals/sex/dose were administered doses of 0, 500, 5,000, 
or 20,000 ppm for 24 months in the feed. A further 10 animals/sex/group 
received the same doses and were sacrificed after 52 weeks. The doses 
administered relative to body weight were 0, 28, 292, or 1,280 mg/kg/
day for males and 0, 40, 415, or 2,067 mg/kg/day for females. The NOAEL 
in the study was 500 ppm (28 mg/kg/day for males and 40 mg/kg/day for 
females) based on body weight decreases in females at 5,000 ppm and 
above, changes in biochemical liver parameters in the absence of 
morphological changes in both sexes at 5,000 ppm and above, and caecal 
mucosal hyperplasia evident at 5,000 ppm and above.
    The NOAEL in the chronic dog study was 17.4 mg/kg/day based on body 
weight, hematology and clinical chemistry effects. The lowest NOAEL in 
the 2-year rat study was determined to be 28 mg/kg/day based on body 
weight, clinical chemistry parameters in the liver, and caecal mucosal 
hyperplasia.
    6. Animal metabolism.--i. A lactating goat was dosed at 10 
milligrams (mg) \14\C- fenhexamid per kilograms/bodyweight on 3 
consecutive days at 24-hour intervals. Fenhexamid was rapidly and 
almost completely absorbed, distributed and eliminated (24.9% in urine, 
38.6% in feces, and 0.03% in milk). The half-life of biliary-fecal 
elimination (primary pathway) was 0.5 hours. The primary residues in 
tissues were unreacted fenhexamid, its glucuronide derivative and the 
4-hydroxy derivative.
    ii. Rats were administered radiolabeled fenhexamid (a single oral 
low dose of 1 mg/kg, a single oral high dose of 100 mg/kg, or 15 
repeated low doses of 1 mg/kg/day). Radiolabeled fenhexamid was rapidly 
eliminated and tissue residues declined rapidly. After 48 hours the 
total radioactivity residue in the body excluding the GI tract, was < 
0.3% of the administered dose in all dose groups. Excretion was rapid 
and almost complete with feces as the major route of excretion. 
Approximately 62-84% of the recovered radioactivity was found in feces, 
and 15-36% in urine within 48 hours post-dosing. Metabolite 
characterization studies showed that the main components detected in 
excreta were the unchanged parent compound (62-75%) and the glucuronic 
acid conjugate of the parent compound (4-23%). The proposed major 
pathway for biotransformation is via conjugation of the aromatic 
hydroxyl group with glucuronic acid. Identification of radioactive 
residues ranged from 88% to 99% and was independent of dose and sex.
    7. Metabolite toxicology. As the primary residues found in rats and 
goat were the parent compound fenhexamid and its glucuronic acid 
conjugate, no additional metabolite toxicology studies are warranted.
    8. Endocrine disruption. Fenhexamid has no endocrine-modulation 
characteristics as demonstrated by the lack of endocrine effects in 
developmental, reproductive, subchronic, and chronic studies.

C. Aggregate Exposure

    1. Dietary exposure.--i. Food. Dietary exposure to fenhexamid is 
limited to the established tolerances for residues of fenhexamid on 
grapes (at 4.0 ppm), raisins (at 6.0 ppm), strawberries (at 3.0 ppm), 
almond nutmeat (at 0.02 ppm), almond hulls (at 2.0 ppm), stonefruit 
except plum, prune, fresh, post-harvest (at 10.0 ppm), plum, prune, 
dried (at 2.5 ppm); plum, prune, fresh (at 1.5 ppm); pear (at 15 ppm), 
bushberries (at 5.0 ppm), caneberries (at 20 ppm), pistachios (at 0.02 
ppm); cucumber (at 2.0 ppm); fruiting vegetables, except non-bell 
peppers (at 2.0 ppm); kiwi, post-harvest (at 15.0 ppm); leafy greens, 
except spinach (at 30.0 ppm); and the proposed tolerances in the 
current submission which are as follows: Pome fruit (at 10 ppm); and 
apple pomace (at 25 ppm).
    ii. Drinking water. Review of the environmental fate data indicates 
that fenhexamid is relatively immobile and rapidly degrades in the soil 
and water. Fenhexamid dissipates in the environment via several 
processes. Therefore, a significant contribution to aggregate risk from 
drinking water is unlikely.
    2. Non-dietary exposure. There is no significant potential for non-
occupational exposure to the general public. The proposed uses are 
limited to agricultural and horticultural use.

D. Cumulative Effects

    Consideration of a common mechanism of fenhexamid toxicity is not 
appropriate at this time since it has a unique mode of action. 
Moreover, there is no significant toxicity observed for fenhexamid. 
Even at toxicology limit doses, only minimal toxicity is observed for 
fenhexamid. Therefore, only the potential risks of fenhexamid are 
considered in the exposure assessment.

[[Page 52688]]

E. Safety Determination

    1. U.S. population. The percent of the cPAD utilized by all current 
uses (almonds, bushberries, caneberries, cucumbers, fruiting vegetables 
(except non-bell peppers), grapes, kiwifruits, leafy greens (except 
spinach), pears, pistachios, raisins, stonefruits and strawberries) was 
estimated by EPA to be 9.9% (September 26, 2003, 68 FR 55513; (FRL-
7326-7)). Arvesta Corporation estimated the chronic dietary exposure to 
fenhexamid resulting from the use on pome fruit, using the DEEM-FCIDTM 
software version as had the US EPA and assuming 100 % of the crop 
treated and residues equal to the MRL. The percent cPAD utilized by all 
current and proposed uses was estimated to be 17.6%. Therefore, the 
estimates of dietary exposure indicate adequate safety margins for the 
overall U.S. population.
    2. Infants and children. The percent of the cPAD utilized by all 
current uses was estimated by EPA to be 19.6% (infants < 1 year) and 
21.8% (children 1 to 2 years) (September 26, 2003, 68 FR 55513; (FRL-
7326-7)). Arvesta Corporation estimated the chronic dietary exposure to 
fenhexamid resulting from the use on pome fruit, as above. The percent 
cPAD utilized by all current and proposed uses was estimated to be 
61.5% (infants < 1 year) and 60.0% (children 1 - 6 years). Therefore, 
the estimates of dietary exposure indicate adequate safety margins for 
children. In assessing the potential for additional sensitivity of 
infants and children to residues of fenhexamid, the available 
developmental toxicity and reproductive toxicity studies and the 
potential for endocrine modulation by fenhexamid were considered. 
Developmental toxicity studies in two species indicate that fenhexamid 
does not impose additional risks to developing fetuses and is not a 
teratogen. The 2-generation reproduction study in rats demonstrated 
that there were no adverse effects on reproductive performance, 
fertility, fecundity, pup survival, or pup development at non-
maternally toxic levels. Maternal and developmental NOAELs and LOAELs 
were comparable, indicating no increase in susceptibility of developing 
organisms. No evidence of endocrine effects was noted in any study. 
Arvesta Corporation therefore concludes that fenhexamid poses no 
additional risk for infants and children and no additional uncertainty 
factor is warranted.

F. International Tolerances

    International tomato tolerances are in effect in France, Germany, 
Greece, Italy, Slovenia, Spain, Turkey (1 ppm) and other EU countries 
(2 ppm). Kiwi tolerances are as follows: Greece, Italy and Slovenia (10 
ppm). Stonefruit tolerances already exist in the USA for pre-harvest 
applications as well as in Canada (6 ppm), Austria (cherry, 5 ppm; 
plum, 2 ppm); Belgium (cherry, 5 ppm); Germany and Slovenia (cherry, 5 
ppm; peach and plum, 2 ppm), Italy (cherry, 5 ppm; apricot, peach and 
plum, 2 ppm); Japan (peach, 1 ppm), Switzerland (cherry, 2 ppm) and the 
UK (plum, 1 ppm) and other EU countries (peach and plum, 1 ppm; cherry, 
5 ppm)

[FR Doc. 04-19614 Filed 8-26-04; 8:45 am]
BILLING CODE 6560-50-S