[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Notices]
[Pages 41345-41349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17617]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0145; FRL-7314-8]


Fenpyroximate; 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 ID number OPP-2003-0145, must be 
received on or before August 11, 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 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. 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-2003-0145. 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

[[Page 41346]]

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-2003-0145. 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-2003-0145. 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-2003-0145.
    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-2003-0145. 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 as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities

[[Page 41347]]

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: June 30, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summaries of the 
petitions were prepared by the petitioner and represent the views 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 (IR-4)

PP 3E6519

    EPA has received a pesticide petition (3E6519) from IR-4, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390 proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a 
tolerance for residues of combined residues of fenpyroximate benzoic 
acid, 4-[[[(E)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) 
methylene]amino] oxy]methyl]-, 1,1-dimethylethyl ester] and its z-
isomer benzoic acid, 4-[[[[(Z)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) 
methylene]amino]oxy]methyl]-,1,1-dimethylethyl ester)]] in or on the 
raw agricultural commodity fruit, pome, group 11 at 0.3 parts per 
million (ppm). Nichino America, Incorporated.

PP 2F6437

    EPA has also received a pesticide petition (2F6437) from Nichino 
America, Inc., 4550 New Linden Hill Road, Wilmington, DE 19808 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing tolerances for residues of 
combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1-
dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3-
dimethyl- 5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]-,1,1-
dimethylethyl ester)]] in or on the following raw agricultural 
commodities: Cotton, undelinted seed at 0.1 ppm, cotton, gin byproducts 
at 9.0 ppm, apple, fruit at 0.08 ppm, and grape at 0.3 ppm. 
Additionally, EPA has received request for tolerances for the combined 
residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1-
dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]-,1,1- 
dimethylethyl ester)] and the acid metabolite ((E)-4-[(1,3-dimethyl-5-
phenoxypyrazol-4-yl)-methyleneamino oxymethyl benzoic acid (M-3)], all 
expressed as fenpyroximate in or on milk at 0.01 ppm; meat at 0.02 ppm; 
fat at 0.8 ppm; kidney at 0.5 ppm; liver at 0.5 ppm; and meat 
byproducts at 0.01 ppm of cattle, goats, hogs, horses and sheep. 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 summary has 
been prepared by the Nichino American, Inc., Wilmington, DE 19808, the 
registrant.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of fenpyroximate and z- isomer 
has been studied in cotton, apples, grapes, and citrus and is 
adequately understood.
    2. Analytical method. As a result an enforcement method has been 
developed which involves extraction of fenpyroximate from crops with 
acetone, filtration, partitioning and cleanup, and analysis by gas 
chromatography using a nitrogen/phosphorous detector. This method 
allows detection of residues at or above the proposed tolerances. The 
method has undergone independent laboratory validation as required by 
PR Notices 88-5 and 96-1.
    3. Magnitude of residues--i. Magnitude of residues in crops field 
residue trials meeting. EPA study requirements have been conducted at 
the maximum label rate for cotton, grapes, and pome fruit. Results from 
these trials demonstrate that the highest fenpyroximate and z-isomer 
residues found will not exceed the proposed tolerances when the product 
is applied following the proposed use directions.
    ii. Magnitude of the residue in animals--a. Ruminants. Maximum 
residues of fenpyroximate, z-isomer, and acid metabolite in a cattle 
feeding study demonstrate that the highest fenpyroximate, z-isomer, and 
acid metabolite, combined as fenpyroximate, will not exceed the 
proposed tolerances in or on milk (0.01 ppm); meat (0.02 ppm), fat 
(0.8) ppm, kidneys and liver (0.5) ppm, and meat byproducts (0.01) ppm 
in cattle, goats, hogs, horses, sheep.
    b. Poultry. The maximum poultry dietary burden results from a diet 
composed of cotton meal for a total dietary burden that is 
significantly lower than the levels that would require the proposal of 
tolerances in poultry. This conclusion is based on the exaggerated rate 
field crop studies carried out on fenpyroximate and the z-isomer. 
Therefore, an exemption from tolerances in poultry meat, poultry meat 
by-products, fat and eggs under 40 CFR 180.6(a)(3) and (b) is proposed 
as it is not possible to establish with certainty whether finite 
residues will be incurred, but there is no reasonable expectation of 
finite residues.

B. Toxicological Profile

    A full description of the studies describing the toxicity of 
fenpyroximate can be found in the posting for the import tolerances on 
hops and wine grapes in the Federal Register of April 10, 2001 (66 FR 
18561) (FRL-6773-2).
    1. Animal metabolism. The qualitative nature of the residues of 
fenpyroximate and z-isomer and acid metabolite, in animals is 
adequately understood. Fenpyroximate was not metabolized to volatiles 
to any significant degree. The majority of either benzyl or pyrazole 
labels (approximately 70% to 92%) is excreted in the feces. Urinary 
excretion accounts for less (approximately 9% to 18%) of the label. 
Thus, feces and urine are the major routes of excretion for 
fenpyroximate. Tissue did not accumulate fenpyroximate or its 
metabolites to any great extent. The greatest levels of label were in 
liver, kidneys, adrenals, and fat (to a lesser degree). In blood, 
nearly all the label is in the plasma.
    2. Endocrine disruption. Chronic, lifespan, and multigenerational 
bioassays in mammals and acute and subchronic studies on aquatic 
organisms and wildlife did not reveal any endocrine effects for 
fenpyroximate. Any endocrine-related effects would have been detected 
in this

[[Page 41348]]

comprehensive series of required tests. The probability of any such 
effect due to agricultural uses of fenpyroximate is negligible.

C. Aggregate Exposure

    1. Dietary exposure. The potential dietary exposure to 
fenpyroximate has been calculated from the proposed tolerances for use 
on cotton, grapes, and pome fruit. These very conservative chronic 
dietary exposure estimates used the tolerance value for all the raw 
agricultural commodities. In addition, these estimates assume that 100% 
of the crops contain fenpyroximate residues.
    i. Food. Chronic dietary exposure to fenpyroximate was estimated on 
the basis of 100% crop treatment for cotton, grapes, and pome fruit and 
assuming tolerance level residues on these crops. These estimated 
exposures were compared to the chronic dietary RfD for fenpyroximate, 
which has already been established by EPA at 0.010 milligrams/kilogram/
day (mg/kg/day), in connection with the import tolerance on wine grapes 
and hops.
    ii. Drinking water. Laboratory and field data have demonstrated 
that fenpyroximate is immobile in soil and will not leach into ground 
water. Other data show that fenpyroximate is virtually insoluble in 
water. As a result, NAI concludes that residues reaching surface waters 
from field runoff will quickly adsorb to sediment particles and be 
partitioned from the water column. Further, a screening evaluation of 
leaching potential for other miticides was conducted using EPA's 
Pesticide Root Zone Model (PRZM) and Screening Concentration in Ground 
Water (SCI-GROW). Based on this screening assessment, the potential 
concentrations of fenpyroximate and z-isomer in water at depths of 1 
and 2 meters are essentially zero (<1 part per trillion (ppt)). Surface 
water concentrations using PRZM and EXAMS were predicted in the 
simulated pond of 0.0242 part per billion (ppb).
    2. Non-dietary exposure. There are no registered or proposed 
residential uses of fenpyroximate. Thus, a residential exposure 
assessment is not required. Exposure to fenpyroximate for the mixer/
loader/ground boom applicator was calculated using the Pesticides 
Handlers Exposure Data base (PHED). These PHED assessments were based 
on a 70 kg operator treating <50 acres per day using ground boom 
equipment on both apples and grapes and 80 acres per day on cotton by 
ground application with an operator treating at a maximum use rate of 
0.1 lb active ingredient per acre. All mixer/loaders and workers/
operators were assumed to be wearing gloves, long pants and long-
sleeved shirts.

D. Cumulative Effects

    In consideration of potential cumulative effects of fenpyroximate 
and other substances that may have a common mechanism of toxicity, to 
our knowledge there are no currently available data or other reliable 
information indicating that any toxic effects produced by fenpyroximate 
would be cumulative with those of other chemical compounds; thus only 
the potential risks of fenpyroximate have been considered in this 
assessment of its aggregate exposure.

E. Safety Determination

    1. U.S. population--i. Acute. Using the 100% crop treatment 
scenario the acute population adjusted dose (aPAD) for the general 
population is 0.002309 mg/kg/day. Of the standard subgroups which are 
analyzed by the Dietary Exposure Evaluation Model (DEEM), the subgroup 
with the highest exposures is infants (<1 year) with an acute dietary 
exposure estimated at 0.006368 mg/kg/day (12.74% of the acute reference 
aRfD). For children in the age brackets 1-6 years and 7-12 years, the 
dietary exposures are approximately 0.004716 mg/kg/day (9.43% of the 
aRfD) and 0.002581 mg/kg/day (5.16% of the aRfD), respectively. Males 
and females aged 13 and older have an estimated acute dietary exposure 
of 0.001054 and 0.000911 mg/kg/day, respectively (2.11% and 1.82% of 
the aRfD, respectively). Even applying the Food Quality Protection Act 
(FQPA) factor of 10X to females aged 13 and older the percent aRfD 
utilization is only a modest 11.82%. All values for percentage 
utilization of the aRfD are well below 100% and no value exceeds 
12.74%.
    ii. Chronic. Of the standard subgroups which are analyzed by the 
DEEM, and using the conservative estimates, of 100% crop treatment 
scenario, the chronic population adjusted dose (cPAD) for the general 
population, is approximately 0.0002579 mg/kg/day (which is 2.58% of the 
RfD). This value is based on the no observed adverse effect level 
(NOAEL) of 0.97 mg/kg/day observed in the chronic rat feeding study, 
the worse case estimate of chronic dietary exposure of fenpyroximate 
from cotton, grape, and pome fruit and a safety (uncertainty) factor of 
100.
    2. Non-dietary exposure--i. Acute. The margins of exposure relative 
to the acute dietary endpoint (5 mg/kg/day) are all in excess of 1,000. 
Therefore, there is a reasonable certainty that no harm will occur from 
acute exposure to crops treated at the maximum labeled use rates and 
minimum preharvest intervals for fenpyroximate. Worker exposure (mixer/
loader and applicator) estimates provide for margins of safety of >100 
in all scenarios. Worker exposure is therefore expected, to a 
reasonable degree of scientific certainty, to be without harm. Based on 
the above, exposures of the U.S. population to fenpyroximate associated 
with the uses addressed in this reduced risk submission are expected, 
to a reasonable degree of scientific certainty, to be without harm.
    ii. Chronic. The margins of exposure relative to the chronic 
dietary endpoint are all in excess of 1,700. Therefore, there is a 
reasonable certainty that no harm will occur from chronic exposure to 
crops treated at the maximum labeled use rates and minimum preharvest 
intervals for fenpyroximate.
    3. Infants and children--i. Acute. Using the 100% crop treatment 
scenario, the subgroup with the highest exposures is infants (<1 year) 
with an acute dietary exposure estimated at 0.006368 mg/kg/day (12.74% 
of the aRfD). For children in the age brackets 1-6 years and 7-12 
years, the acute dietary exposures are approximately 0.004716 mg/kg/day 
(9.43% of the aRfD) and 0.002581 mg/kg/day (5.16% of the aRfD), 
respectively. Acute dietary exposure of infants and children is 
therefore expected, to a reasonable degree of scientific certainty, to 
be without harm. Based on the above, exposures of infants and children 
to fenpyroximate associated with the uses addressed in this reduced 
risk submission are expected, to a reasonable degree of scientific 
certainty, to be without harm.
    ii. Chronic. Using the 100% crop treatment scenario, infants (less 
than 1 year) have the highest chronic exposure (0.0009228 mg/kg/day, 
which is 9.23 % of the RfD). For children in the age brackets 1-6 years 
and 7-12 years, the dietary exposures are approximately 0.0005244 mg/
kg/day (5.24% of the RfD) and 0.0002733 mg/kg/day (2.73% of the RfD), 
respectively. Chronic dietary exposure of the infants and children is 
therefore expected, to a reasonable degree of scientific certainty, to 
be without harm.
    iii. Conclusion. There is a complete toxicity data base for 
fenpyroximate and exposure data are conservatively estimated based on 
data that reasonably account for potential exposures. Based on these 
risk assessments, Nichino America, Inc. concludes that, there is a 
reasonable certainty that no harm will result to infants and children 
from

[[Page 41349]]

aggregate exposure to combined residues of fenpyroximate.

F. International Tolerances

    Codex Maximum Residue Levels (MRLs) have been established for 
residues of fenpyroximate and z-isomer on apples in Brazil at 0.1 ppm, 
France 0.2 ppm, Japan 1.0 ppm, Spain (pome fruits) 0.3 ppm, and 
Switzerland 0.2 ppm. Codex MRLs have been established on grapes in 
France at 0.2 ppm, Japan 2.0 ppm, Spain 0.3 ppm, and Switzerland 0.2 
ppm.

[FR Doc. 03-17617 Filed 7-10-03; 8:45 am]
BILLING CODE 6560-50-S