[Federal Register Volume 69, Number 120 (Wednesday, June 23, 2004)]
[Notices]
[Pages 35024-35028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13857]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0042; FRL-7358-3]


Spinosad; 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.

-----------------------------------------------------------------------

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-2004-0042, must be 
received on or before July 23, 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: William G. Sproat, Jr., Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8587]; 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 codes 111)
     Animal production (NAICS codes 112)
     Food manufacturing (NAICS codes 311)
     Pesticide manufacturing (NAICS codes 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-2004-0042. 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

[[Page 35025]]

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 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-2004-0042. 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-2004-0042. 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-2004-0042.
    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-2004-0042. 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.

[[Page 35026]]

    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: June 8, 2004.
Lois Rossi,
Director, Registration Division, Office of PesticidePrograms.

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 Dow AgroScience LLC, 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.

 AgroSciences LLC

 PP 3F6754

     EPA has received a pesticide petition PP 3F6754 from Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 
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 ofspinosad in or on the raw 
agricultural commodity stored grain (wheat, barley, corn, oats, rice, 
and sorghum/milo), soybean, sunflower, peanut, and cotton seed at 1 
part per million (ppm) and birdseed at 3 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 spinosad in plants apples, 
cabbage, cotton, tomato, and turnip, and animals (goats and poultry) 
are adequately understood for the purposes of these tolerances. A 
rotational crop study showed no carryover of measurable spinosad 
related residues in representative test crops.
    2. Analytical method. There is a practical method (immunoassay) for 
detecting (0.005 ppm) and measuring (0.01 ppm) levels of spinosad in or 
on food with a limit of detection that allows monitoring of food with 
residues at or above the level set for these tolerances. The method has 
had a successful method tryout in the EPA laboratories.
    3. Magnitude of residues. Tolerances as high as 22 ppm for dried 
herb, 10 ppm (Brassica) and 8 ppm (leafy vegetables) have been 
previously established for crop commodities treated with spinosad. 
Magnitude of residue studies were conducted at three sites for 
artichokes. Residues found in these studies ranged from 0.062 to 0.156 
ppm. Magnitude of residue studies were conducted at three sites for 
asparagus. Residues found in these studies were all less than 0.009 
ppm. Magnitude of residues studies were conducted at five sites for 
garden beet tops (one of the representative crops for the leaves of 
root and tuber vegetable crop group). Residues found in these studies 
ranged from 0.03 to 4.0 ppm. Previously submitted data used in support 
of the established residue tolerance on Brassica (cole) leafy 
vegetables are also to be used in support of the proposed residue 
tolerance for leaves of root and tuber vegetables. Magnitude of residue 
studies were conducted at six sites for pears (one of the 
representative crops for the pome fruit crop group). Residues found in 
these studies ranged from non-detectable to 0.08 ppm. Previously 
submitted data used in support of the established residue tolerance on 
apples are also to be used in support of the proposed residue tolerance 
for pome fruit. Magnitude of residue studies were conducted at 4 sites 
on pecans (one of the representative crops for the tree nut crop 
group). Residues found in these studies ranged from less than 0.0010 to 
0.0076 ppm. Previously submitted data used in support of the 
established residue tolerance on almonds are to be used also, in 
support of the proposed residue tolerance for tree nuts and pistachio. 
A magnitude of residue study was conducted at 20 sites on tomatoes and 
peppers (two of the representative crops for the fruiting vegetables 
crop group). Residues found in this study ranged from less than 0.01 to 
0.13 ppm in tomatoes, and 0.01 to 0.18 ppm in peppers. Previously 
submitted data used in support of the established residue tolerance on 
fruiting vegetables (except cucurbits) are to be used in support of the 
proposed residue tolerance for okra. Magnitude of residue studies were 
conducted at six sites for cranberry. No quantifiable residues >0.01 
ppm were observed in any test sample. Magnitude of residue studies were 
conducted at five sites for garden beet roots (one of the 
representative crops for the root and tuber vegetable crop group) and 
tops (one of the representative crops for the leaves of root and tuber 
vegetable crop group). Residues found in beet tops ranged from 0.03 to 
4.0 ppm. Previously submitted data used in support of the established 
residue tolerance on Brassica (cole) leafy vegetables are also to be 
used in support of the proposed residue tolerance for leaves of root 
and tuber vegetables. These data support tolerances of 0.1 ppm in 
garden and sugar beet roots and a 10.0 ppm tolerance for Crop Group 2.

B. Toxicological Profile

    1. Acute toxicity. Spinosad has low acute toxicity. The rat oral 
LD50 is 3,738 milligrams/kilogram (mg/kg) for males and 
>5,000 mg/kg for females, whereas the mouse oral LD50 is 
>5,000 mg/kg. The rabbit dermal LD50 is >5,000 mg/kg and the 
rat inhalation LC50 is >5.18 milligrams per liter (mg/L) 
air. In addition, spinosad is not a skin sensitizer in guinea pigs and 
does not produce significant dermal or ocular irritation in rabbits. 
End use formulations of spinosad that are water based suspension 
concentrates have similar low acute toxicity profiles.
    2. Genotoxicty. Short term assays for genotoxicity consisting of a 
bacterial reverse mutation assay (Ames test), an

[[Page 35027]]

in vitro assay for cytogenetic damage using the Chinese hamster ovary 
cells, an in vitro mammalian gene mutation assay using mouse lymphoma 
cells, an in vitro assay for DNA damage and repair in rat hepatocytes, 
and an in vivo cytogenetic assay in the mouse bone marrow (micronucleus 
test) have been conducted with spinosad. These studies show a lack of 
genotoxicity.
    3. Reproductive and developmental toxicity. Spinosad caused 
decreased body weights in maternal rats given 200 mg/kg/day by gavage 
highest dose tested (HDT). This was not accompanied by either embryo 
toxicity, fetal toxicity, or teratogenicity. The no observed adverse 
effect levels (NOAELs) for maternal and fetal toxicity in rats were 50 
and 200 mg/kg/day, respectively. A teratology study in rabbits showed 
that spinosad caused decreased body weight gain and a few abortions in 
maternal rabbits given 50 mg/kg/day HDT. Maternal toxicity was not 
accompanied by either embryo toxicity, fetal toxicity, or 
teratogenicity. The NOAELs for maternal and fetal toxicity in rabbits 
were 10 and 50 mg/kg/day, respectively. In a two-generation 
reproduction study in rats, parental toxicity was observed in both 
males and females given 100 mg/kg/day HDT. Perinatal effects (decreased 
litter size and pup weight) at 100 mg/kg/day were attributed to 
maternal toxicity. The NOEL for maternal and pup effects was 10 mg/kg/
day.
    4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary 
studies and showed NOELs/NOAELs of 4.89 and 5.38 mg/kg/day, 
respectively in male and female dogs; 6 and 8 mg/kg/day, respectively 
in male and female mice; and 33.9 and 38.8 mg/kg/day, respectively, in 
male and female rats. No dermal irritation or systemic toxicity 
occurred in a 21-day repeated dose dermal toxicity study in rabbits 
given 1,000 mg/kg/day.
    5. Chronic toxicity. Based on chronic testing with spinosad in the 
dog and the rat, the EPA has set a reference dose (RfD) of 0.027 mg/kg/
day for spinosad. The RfD has incorporated a 100-fold safety factor to 
the NOELs found in the chronic dog study to account for inter-specoes 
and intra-species variation. The NOELs shown in the dog chronic study 
were 2.68 and 2.72 mg/kg/day, respectively for male and female dogs. 
The NOELs (systemic) shown in the rat chronic/carcinogenicity/
neurotoxicity study were 9.5 and 12.0 mg/kg/day, respectively for male 
and female rats. Using the Guidelines for Carcinogen Risk Assessment 
published September 24, 1986 (51 FR 33992), it is proposed that 
spinosad be classified as Group E for carcinogenicity (no evidence of 
carcinogenicity) based on the results of carcinogenicity studies in two 
species. There was no evidence of carcinogenicity in an 18-month mouse 
feeding study and a 24-month rat feeding study at all dosages tested. 
The NOELs shown in the mouse oncogenicity study were 11.4 and 13.8 mg/
kg/day, respectively for male and female mice. A maximum tolerated dose 
was achieved at the top dosage level tested in both of these studies 
based on excessive mortality. Thus, the doses tested are adequate for 
identifying a cancer risk. Accordingly, a cancer risk assessment is not 
needed.
     Spinosad did not cause neurotoxicity in rats in acute, subchronic, 
or chronic toxicity studies.
    6. Animal metabolism. There were no major differences in the 
bioavailability, routes or rates of excretion, or metabolism of 
spinosyn A and spinosyn D following oral administration in rats. Urine 
and fecal excretions were almost completed in 48-hours post-dosing. In 
addition, the routes and rates of excretion were not affected by 
repeated administration.
    7. Metabolite toxicology. The residue of concern for tolerance 
setting purposes is the parent material (spinosyn A and spinosyn D). 
Thus, there is no need to address metabolite toxicity.
    8. Endocrine disruption. There is no evidence to suggest that 
spinosad has an effect on any endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. For purposes of assessing the potential 
dietary exposure from use of spinosad on the raw agricultural 
commodities listed in this notice as well as from other existing 
spinosad crop uses, a conservative estimate of aggregate exposure is 
determined by basing the theoretical maximum residue contribution 
(TMRC) on the proposed tolerance level for spinosad and assuming that 
100% of these proposed new crops and other existing (registered for 
use) crops grown in the U.S. were treated with spinosad. The TMRC is 
obtained by multiplying the tolerance residue levels by the consumption 
data which estimates the amount of crops and related foodstuffs 
consumed by various population subgroups. The use of a tolerance level 
and 100% of crop treated clearly results in an overestimate of human 
exposure and a safety determination for the use of spinosad on crops 
cited in this summary that is based on a conservative exposure 
assessment. In addition for the use of dermal application of spinosad 
to cattle, the risk assessment applies a conservative (overestimate) 
35% percent of market share for the dermal application to cattle to the 
tolerance levels for animal commodities based on existing crop uses.
     Drinking water. Another potential source of dietary exposure is 
residues in drinking water. Based on the available environmental 
studies conducted with spinosad wherein it's properties show little or 
no mobility in soil, there is no anticipated exposure to residues of 
spinosad in drinking water. In addition, there is no established 
maximum concentration level for residues of spinosad in drinking water.
    2. Non-dietary exposure. Spinosad is currently registered for use 
on a number of crops including cotton, fruits, and vegetables in the 
agriculture environment. Spinosad is also currently registered for 
outdoor use on turf and ornamentals at low rates of application (0.04 
to 0.54 lb active ingredents (a.i.,) per acre and indoor use for 
drywood termite control (extremely low application rates used with no 
occupant exposure expected). Thus, the potential for non-dietary 
exposure to the general population is considered negligible.

D. Cumulative Effects



     The potential for cumulative effects of spinosad and other 
substances that have a common mechanism of toxicity is also considered. 
In terms of insect control, spinosad causes excitation of the insect 
nervous system, leading to involuntary muscle contractions, prostration 
with tremors, and finally paralysis. These effects are consistent with 
the activation of nicotinic acetylcholine receptors by a mechanism that 
is clearly novel and unique among known insecticidal compounds. 
Spinosad also, has effects on the gamma aminobatopic acid (GABA) 
receptor function that may contribute further to its insecticidal 
activity. Based on results found in tests with various mammalian 
species, spinosad appears to have a mechanism of toxicity like that of 
many amphiphilic cationic compounds. There is no reliable information 
to indicate that toxic effects produced by spinosad would be cumulative 
with those of any other pesticide chemical. Thus, it is appropriate to 
consider only the potential risks of spinosad in an aggregate exposure 
assessment. Spinosad is classified in a mechanism-of-action group of 
its own for the purpose of resistance management in insects and for 
rotation with other crop protection products.

[[Page 35028]]

E. Safety Determination



    1. U.S. population. Using the conservative exposure assumptions and 
the RfD described above, the aggregate exposure to spinosad use on 
existing crop uses utilizes 30% of the RfD for the U.S. population from 
a previous EPA assessment based on the chronic population adjusted dose 
(cPAD) (as posted in the Federal Register of September 27, 2002) (FRL-
7199-5). EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. The new crop uses proposed in this notice are 
minor ones and are expected to contribute only a negligible impact to 
the RfD. Thus, it is clear that there is reasonable certainty that no 
harm will result from aggregate exposure to spinosad residues on 
existing and all pending crop uses listed in this notice.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of spinosad, data from 
developmental toxicity studies in rats and rabbits and a 2-generation 
reproduction study in the rat are considered. The developmental 
toxicity studies are designed to evaluate adverse effects on the 
developing organism resulting from pesticide exposure during prenatal 
development. Reproduction studies provide information relating to 
effects from exposure to the pesticide on the reproductive capability 
and potential systemic toxicity of mating animals and on various 
parameters associated with the well-being of pups.
     FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base. Based on the current toxicological data requirements, the 
data base for spinosad relative to prenatal and postnatal effects for 
children is complete. Further, for spinosad, the NOELs in the dog 
chronic feeding study which was used to calculate the RfD (0.027 mg/kg/
day) are already lower than the NOELs from the developmental studies in 
rats and rabbits by a factor of more than 10-fold. Concerning the 
reproduction study in rats, the pup effects shown at the highest dose 
tested were attributed to maternal toxicity. Therefore, it is concluded 
that an additional uncertainty factor is not needed and that the RfD at 
0.027 mg/kg/day is appropriate for assessing risk to infants and 
children. In addition, the EPA has determined that the 10X factor to 
account for enhanced sensitivity of infants and children is not needed 
because:
    i. The data provided no indication of increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure to spinosad. In 
the prenatal developmental toxicity studies in rats and rabbits and 
two-generation reproduction in rats, effects in the offspring were 
observed only at or below treatment levels that resulted in evidence of 
parental toxicity.
    ii. No neurotoxic signs have been observed in any of the standard 
required studies conducted.
    iii. The toxicology data base is complete and there are no data 
gaps.
    iv. Exposure data are complete or are estimated based on data that 
reasonably account for potential exposure.
     Using the conservative exposure assumptions previously described 
(tolerance level residues), the percent RfD utilized by the aggregate 
exposure to residues of spinosad on existing crop uses is 69% for 
children 1-6 years old, the most sensitive population subgroup from an 
EPA assessment based on the chronic population adjusted dose (cPAD) (as 
posted in the Federal Register May 3, 2000. Additional refinements to 
the dietary exposure based on market share information would reduce the 
exposure of children 1-6 years old to less than 50% the cPAD. Grain 
treated under a tolerance is expected to have only a slight impact to 
the RfD since the vast majority of grain is untreated. Thus, based on 
the completeness and reliability of the toxicity data and the 
conservative exposure assessment, it is concluded, that there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to spinosad residues on the above proposed uses 
including existing crop uses.

F. International Tolerances

     There is no Codex maximum residue levels established for residues 
of spinosad.

[FR Doc. 04-13857 Filed 6-22-04; 8:45 am]
BILLING CODE 6560-50-S