[Federal Register Volume 69, Number 32 (Wednesday, February 18, 2004)]
[Notices]
[Pages 7632-7635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-270]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0213; FRL-7343-2]


Spirodiclofen; Notice of Filing a Pesticide Petition to Establish 
a 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-2003-0213, must be 
received on or before March 19, 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: Rita Kumar, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 308-8291; 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. 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 ID number OPP-2003-0213. 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 on 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

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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-2003-0213. 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-2003-0213. 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-2003-0213.
    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-2003-0213. 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: January 27, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by Bayer CropScience 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.

Bayer CropScience

PP 2F6469

    EPA has received a pesticide petition (PP 2F6469) from Bayer 
CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle 
Park, NC 27709 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 
Spirodiclofen; 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro [4,5]dec-3-en-4-
yl ester 2,2-dimethyl-butanoic acid, in or on the raw agricultural 
commodities citrus fruit group at 0.3 parts per million (ppm), citrus 
pulp, dried, at 0.4 ppm, citrus oil at 20 ppm, pome fruit group at 0.8 
ppm,

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pome fruit pomace, wet, at 6.0 ppm, stone fruit group at 1.0 ppm, tree 
nut group at 0.05 ppm, almond hulls at 20 ppm, pistachios at 0.05 ppm, 
grape at 2.0 ppm and grape, raisin at 4.0 ppm. Spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl ester 2,2-dimethyl-
butanoic acid, and/or its enol metabolite, 3-(2,4-dichlorophenyl)-4-
hydroxy-1-oxaspiro [4,5]dec-3-en-2-one, in or on the raw agricultural 
commodities cattle, fat, at 0.01 ppm and cattle, meat by-products, at 
0.05 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.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of spirodiclofen in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabeled spirodiclofen in various crops, all showing 
similar results. The residue of concern is spirodiclofen.
    2. Analytical method. Adequate analytical methodology using LC/MS/
MS detection is available for enforcement purposes.
    3. Magnitude of residues. Complete residue data exists for 
spirodiclofen on these crops and crop groupings. The data support the 
requested tolerances.

B. Toxicological Profile

    1. Acute toxicity. Oral and dermal LD50 values were 
>2,000 milligrams/kilogram body weight (mg/kg bwt). Inhalation 
LC50 values were >5,030 mg/m3 air. Spirodiclofen 
was not irritating to rabbit skin or eyes but did cause skin 
sensitization in the Magnusson/Kligman maximization test in guinea 
pigs. Acute toxicity studies for spirodiclofen support an overall 
toxicity Category III.
    2. Genotoxicity. Several genotoxicity tests were conducted to test 
for point-mutagenic activity, chromosome aberration in vitro and in 
vivo, and for DNA repair. All tests conducted were negative, indicating 
no evidence of mutagenic or genotoxic potential.
    3. Reproductive and developmental toxicity. An oral developmental 
toxicity study in rat did not reveal any evidence of teratogenic 
potential. The maternal and developmental no observed adverse effect 
levels (NOAELs) were 1,000 mg/kg bwt/day. An oral developmental 
toxicity study in rabbits demonstrated a maternal NOAEL of 100 mg/kg 
bwt/day and did not reveal any teratogenic potential. A two-generation 
study in rats, with a parental toxicity NOAEL of 5.2 mg/kg bwt/day, did 
not reveal evidence of a primary reproductive toxicity potential. The 
reproductive NOAEL was 26.2 mg/kg bwt/day based on various clinical and 
histopathological findings at higher dose levels.
    4. Subchronic toxicity. A subchronic toxicity feeding study with 
rats over 90 days demonstrated a NOAEL of 32.1 and 8.1 mg/kg bwt/day 
for males and females, respectively, based on effects on the lipid 
metabolism (decrease of triglycerides and cholesterol), liver effects 
(increase in transaminases) and adrenal effects (vacuolation) at the 
higher dose levels. A subchronic feeding study in mice over 13-weeks 
revealed no clinical toxicological signs. A NOAEL of 30.1 mg/kg bwt/day 
for females was observed (a clear NOAEL was not established for males). 
A 14-week feeding study in dogs demonstrated a NOAEL of 7.7 mg/kg bwt/
day.
    5. Chronic toxicity. A 24-month combined chronic feeding/
carcinogenicity study in rats demonstrated a NOAEL of 14.7 mg/kg bwt/
day. An oncogenicity study in the mouse revealed a NOAEL of 4.1 mg/kg 
bwt/day. Uterine and testicular oncogenicity was noted in the rat and 
hepatic neoplasia was observed in the mouse. A 1-year feeding study 
with dog demonstrated a NOAEL of 1.38 mg/kg bwt/day based on adrenal 
effects (vacuolization) as well as changes in circulating cholesterol 
and prostate weight at higher dose levels.
    6. Animal metabolism. Metabolism and pharmacokinetic studies in the 
rat demonstrate that spirodiclofen residues are rapidly absorbed, 
metabolized and eliminated. The primary metabolite is the enol, which 
is formed by cleavage of the alkyl ester group, but numerous other 
metabolites are also formed.
    7. Metabolite toxicology. The residue of concern is spirodiclofen 
and its enol metabolite, which is a product of hydrolysis in mammalian 
systems, as well as in the environment. Since the enol is inherently 
present after administration, toxicology data for this metabolite is 
completely supported by data obtained for spirodiclofen.
    8. Endocrine disruption. The mammalian mode of action for 
spirodiclofen includes that classified as inhibitory to steroid 
biosynthesis, resulting in an indirect and endogenously-mediated 
toxicological response. Effects do not have an impact on fertility, 
reproduction, developmental or neuropathological parameters. Additional 
mechanistic studies with the chemical indicated that there is no direct 
effect on the endocrine system as there is no interaction with hormone 
receptors.

C. Aggregate Exposure

    1. Dietary exposure. For the acute dietary analysis, the acute 
reference dose (aRfD), of 1.0 mg/kg/day was derived from a NOAEL of 100 
mg/kg based on a prenatal developmental toxicity study in rabbits and 
the application of an uncertainty factor (UF) of 100 to account for 
inter-species extrapolation and intra-species variability. For the 
chronic dietary analysis, the cRfD, of 0.0138 mg/kg/day was derived 
from a NOAEL of 1.38 mg/kg/day based on a 1-year feeding study in dogs 
and the application of an UF of 100. An FQPA safety factor of 3 was 
also applied to the acute and chronic toxicology values, resulting in 
an acute population adjusted dose (aPAD) of 0.33 mg/kg/day and a 
chronic population adjusted dose (cPAD) of 0.0046 mg/kg/day. As a 
conservative measure, the aPAD and cPAD values were used for all 
population sub-groups when conducting the assessments.
    i. Food. Assessments were conducted to evaluate the potential risks 
due to acute and chronic dietary exposure of the entire U.S. population 
and selected population subgroups to residues of spirodiclofen. These 
analyses cover the proposed uses on citrus fruits (grapefruits, lemons, 
and oranges), pome fruits (apples and pears), stone fruits (cherries, 
peaches, and plums), tree nuts (almonds and pecans) and grapes. For the 
acute dietary assessment, 100% crop treated and the highest or highest 
average field trial residues were assumed. For the chronic assessment, 
anticipated market share and average residue values were assumed. For 
the acute analysis, the most highly exposed population subgroup was 
non-nursing infants (< 1-year) with an exposure equal to 2.3% of the 
aPAD at the 95th percentile. Acute exposure of the overall 
U.S. population was equivalent to 0.45% of the aPAD. For the chronic 
dietary analysis, the most highly exposed population subgroup was 
children 1-6 years, with an exposure equal to 1.9% of the cPAD. Chronic 
exposure for the overall U.S. population equated to 0.6% of the cPAD. 
These acute and chronic dietary exposure estimates are well below EPA's 
level of concern for the overall U.S. population as well as the various 
population subgroups.
    ii. Drinking water. Spirodiclofen is immobile in soil; and 
therefore, will not leach into ground water. Additionally, due to 
insolubility in water and a highly lipophilic nature, any residues in

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surfacewater will rapidly bind to soil particles and remain with 
sediment where it is quickly degraded; and therefore, not contribute to 
potential dietary exposure from drinking water. The estimated 
environmental concentration (EEC) values for spirodiclofen and the enol 
metabolite were calculated using the tier I screening concentration in 
ground water (SCI-GROW), screening model for ground water estimates, 
and the tier II PRZM/EXAMS, models with index reservoir (IR) and 
percent crop area (PCA) factor for surface water estimates. The 
potential EEC levels were determined for the maximum usage intensity 
for each crop. The acute and chronic percent of population adjusted 
dose (%PAD) values associated with drinking water exposure were 
calculated based on a NOAEL of 100 mg/kg/day for acute exposure and 
1.38 mg/kg/day for chronic exposure. The uncertainty factor (UF) 
considered in the analysis was 100X, and an additional Food Quality 
Protection Act (FQPA) safety factor of 3X was used both for acute and 
chronic calculations. The SCI-GROW estimated maximum ground water EEC 
level for spirodiclofen and enol combined was 0.003 ppb, suggesting 
that the compounds have a low potential to leach and contaminate the 
ground water under normal use. The highest estimate of the total acute 
concentration in surface water for spirodiclofen and enol combined was 
6.04 parts per billion (ppb). The highest estimate of the total chronic 
concentration in surface water for spirodiclofen and enol combined was 
0.67 ppb. The maximum %PAD calculated, 1.46%, was for infant/children 
chronic exposure. The low %PAD indicates that the human health risk 
associated with the presence of spirodiclofen and/or its enol 
metabolite in drinking water is minimal.
    2. Non-dietary exposure. There are no indoor residential, indoor 
commercial or outdoor residential uses for spirodiclofen. Exposure and 
risk assessments were prepared for both mixer/loader-applicators and 
reentry workers during use of spirodiclofen on citrus, tree nuts and 
pome/stone fruit. Worker margins of exposure (MOE) estimates were 
conservatively based on a NOAEL of 1.38 mg/kg/day, maximum label rates, 
and a dermal absorption value of 2.3%. An occupational exposure 
uncertainty factor of 100 was used in the assessment. Margins of 
exposure total ranged from 360 to 69,000, indicating that the use of 
spirodiclofen poses no significant risk to workers who mix, load and 
apply this product, or to those who reenter treated areas to perform 
post-application activities. These data support the use of a single 
layer of clothing for mixer/loaders and applicators, and gloves for 
mixer/loaders, and a 12-hour REI for reentry workers.

D. Cumulative Effects

    Spirodiclofen represents a new class of chemistry, ketoenoles. 
Bayer will submit information, if necessary, for EPA to consider 
concerning potential cumulative effects of spirodiclofen consistent 
with the schedule established by EPA at 62 Federal Register 42020 (Aug. 
4, 1997) and other EPA publications pursuant to the Food Quality 
Protection Act.

E. Safety Determination

    1. U.S. population. Based on the exposure assessments described 
above and on the completeness and reliability of the toxicity data, it 
can be concluded that total aggregate exposure to spirodiclofen from 
all label uses will utilize less than 5% of the RfD for chronic dietary 
exposures and that margins of exposure in excess of 360 exist for 
aggregate exposure to spirodiclofen for non-occupational exposure. EPA 
generally has no concerns for exposures below 100% of the RfD, because 
the RfD represents the level at or below which daily aggregate exposure 
over a lifetime will not pose appreciable risks to human health. 
Margins of exposure of 100 or more (300 for infants and children) also, 
indicate an adequate degree of safety. Thus, it can be concluded that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to spirodiclofen residues.
    2. Infants and children. In assessing the potential for increased 
sensitivity of infants and children, data from developmental studies in 
both rat and rabbit and a 2-generation reproduction study in the rat 
can be considered. The developmental toxicity studies evaluate any 
potential adverse effects on the developing animal resulting from 
pesticide exposure of the mother during prenatal development. The 
reproduction study evaluates any effects from exposure to the pesticide 
on the reproductive capability of mating animals through two 
generations, as well as any observed systemic toxicity. None of these 
studies conducted with spirodiclofen indicated developmental or 
reproductive effects. The toxicology data which support these uses of 
spirodiclofen include the following: An oral developmental toxicity 
study in rat that did not reveal any evidence of teratogenic potential. 
Maternal and developmental NOAELs were 1,000 mg/kg bwt/day. An oral 
developmental toxicity study in rabbits demonstrated a maternal NOAEL 
of 100 mg/kg bwt/day and did not reveal any teratogenic potential. A 
two-generation study in rats, with a parental toxicity NOAEL of 5.2 mg/
kg bwt/day, did not reveal evidence of a primary reproductive toxicity 
potential. The reproductive NOAEL was 26.2 mg/kg bwt/day based on 
various clinical and histopathological findings at higher dose levels. 
FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children. The additional safety factor may be 
used when prenatal and postnatal threshold effects were observed in 
studies or to account for incompleteness of the toxicity database. 
Based on the toxicological data requirements, the data relative to 
prenatal and postnatal effects in children is complete. No indication 
of increased susceptibility of younger animals was observed in any of 
the above studies. For the population with the highest exposure, non-
nursing infants <1 year old, the acute dietary exposure at the 
95th percentile was 2.3% of the aPAD, equivalent to an MOE 
of 13,167. For the population described as children 1-6 years old, the 
exposure was 1.2% of the aPAD, equivalent to an MOE of 25,638. Acute 
exposure of the overall U.S. population was equivalent to 0.45% of the 
aPAD. For the chronic dietary analysis, the most highly exposed 
population subgroup was children 1-6 years old, with an exposure equal 
to 1.9% of the cPAD. Chronic exposure for the overall U.S. population 
equated to 0.6% of the cPAD.

F. International Tolerances

    Codex maximum residue levels MRLs are not yet established for 
spirodiclofen.
[FR Doc. E4-270 Filed 2-17-04; 8:45 am]
BILLING CODE 6560-50-S