Kasugamycin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 17997-18001 [05-6848]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 17997-18001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6848]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0017; FRL-7704-2]


Kasugamycin; 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-
2005-0017, must be received on or before May 9, 2005.

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:  Mary Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you 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.

[[Page 17998]]

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-2005-0017. 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 https://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  https://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.1. 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 https://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-2005-0017. 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 opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2005-0017. 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-2005-0017.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information

[[Page 17999]]

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-2005-0017. 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 pesticide 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 
pesticide 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: March 28, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition (PP) 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.

Arvesta Corporation as agent for Hokko Chemical Industry Co., Ltd.

PP 3E6579

    EPA has received pesticide petition 3E6579 from Arvesta 
Corporation, 100 First St., Suite 1700, San Francisco, CA 94105 as 
agent for Hokko Chemical Industry Co. Ltd. 4-20, Nihonbashi Hongokucho 
4 Chome, Chuo-Ku, Tokyo 103-8341, Japan, 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 tolerances for 
residues of kasugamycin, 1L-1,3,4/2,5,6-1-deoxy-2,3,4,5,6-pentahydroxy-
cyclohexyl-2-amino-2,3,4,6-tetradeoxy-4-([alpha]-iminoglycino)-[alpha]-
D-arabino-hexopyranoside, in or on the raw agricultural commodity 
fruiting vegetables (Crop Group 8) at 0.04 parts per million (ppm), 
tomato juice at 0.06 ppm, tomato puree at 0.06 ppm, and tomato paste at 
0.25 ppm. EPA has determined that the 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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The nature of residues of kasugamycin in 
tomato was investigated using \14\C radiolabeled kasugamycin. Parent 
kasugamycin was the primary component in both fruit and foliage. The 
main metabolite in fruit, present at a maximum level of 0.01 ppm, was 
identified as kasugamycinic acid, resulting from the conversion of the 
iminomethyl function to a carboxylic acid. Additional investigation of 
extracts from foliage indicated the presence of:
    i. 2-N-acetyl kasugamycin, formed by acylation of the primary 
amine.
    ii. Kasuganobiosamine, formed by loss of the carboxylic acid 
function of kasugamycinic acid.
    iii. Conjugates of kasugamycin and kasugamycinic acid.
 However, of the minor metabolites found in the foliage, only the 
conjugates were observed in tomato fruit.
    2. Analytical method. A practical analytical method for detecting 
and measuring levels of kasugamycin has been developed and validated in 
all appropriate agricultural commodities. This analytical method is 
suitable for monitoring of food with residues at the levels proposed 
for the tolerances. The limit of quantitation (LOQ) for this method is 
0.04 ppm. An independent laboratory validation of the residue 
analytical method was successful.
    3. Magnitude of residues. The number of field residue trials 
required for an import tolerance is based on the percent of total 
consumed crop commodity attributed to imports from countries where the 
product is or is intended to be registered for use on the crop. The 
number of trials may be reduced if a crop group tolerance is requested. 
Using this consideration, EPA determined that the residue field program 
should consist of three trials on bell pepper, three trials on non-bell 
pepper, and eight trials on tomato. Field residue trials in support of 
this import tolerance were conducted at sites representative of 
locations in which the product will be used on the intended crops with 
applications at the

[[Page 18000]]

maximum use rate for each crop. As a result of the field trials, the 
tolerance proposed for the fresh fruiting vegetables is 0.04 ppm. A 
tomato processing study was not conducted. However, using the 
detectable levels of kasugamycin residues in the tomato fruits, the 
expected levels of residues in tomato juice, tomato puree, and tomato 
paste were calculated using the maximum theoretical concentration 
factors from the harmonized test guideline OPPTS 860.1520 of 1.4, 1.4, 
and 5.5, respectively. As a result of these calculations, the following 
tolerances are proposed for tomato processing commodities: 0.06 ppm 
(tomato juice), 0.06 ppm (tomato puree), and 0.25 ppm (tomato paste).

B. Toxicological Profile

    A full battery of toxicology testing including studies of acute, 
subchronic, chronic, oncogenicity, developmental, reproductive, and 
genotoxicity effects is available for kasugamycin. The acute oral 
toxicity, the only acute testing required for import tolerances, is 
low. Subchronic and chronic studies exhibit no-observed-effects-level 
(NOEL) values from a low 5 milligram/kilogram/day (mg/kg/day) (2-year 
chronic toxicity in dogs) to 135 mg/kg/day (13-week feeding study with 
mice). Kasugamycin is not oncogenic and weight-of-evidence indicates it 
is not genotoxic. There are no concerns of developmental or 
reproductive effects. The lowest chronic NOEL of 3 mg/kg/day is taken 
from the rabbit maternal toxicity in the developmental study.
    1. Acute toxicity. The acute oral toxicity for kasugamycin (the 
only study required for import tolerances establishment) is very low. 
The acute oral Lethal Dose to 50% (LD50) is greater than 
5,000 mg/kg, which will gives kasugamycin a Toxicity Category IV.
    2. Genotoxicty. Kasugamycin was negative in the following assays: 
Bacterial reverse mutation, Chinese hamster ovary (CHO), chromosomal 
aberration (in vitro), mammalian erythrocyte micronucleus, unscheduled 
DNA synthesis,  in vitro mammalian cell gene mutation. Overall, it is 
unlikely that kasugamycin presents a genetic hazard.
    3. Reproductive and developmental toxicity. Developmental effects 
of kasugamycin were studied in rats and rabbits and multi-generational 
effects on reproduction were studied in rats.
    i. Rat developmental. In the developmental toxicity study conducted 
with rats the maternal NOEL is 40 mg/kg/day based on reduced body 
weight gain and food consumption. There were no developmental effects 
and the developmental NOEL is 1,000 mg/kg/day the highest dose tested.
    ii. Rabbit developmental. In the developmental toxicity study 
conducted with rabbits the maternal NOEL is 3 mg/kg/day based on 
reduced body weight gain and food consumption, two abortions and one 
total litter loss. There were no developmental effects and the 
developmental NOEL is 10 mg/kg/day the highest dose tested.
    iii. Reproduction. In the rat reproduction study the parental NOEL 
is 10 mg/kg/day based on decrease body weight. The reproductive NOEL is 
50 mg/kg/day (based on increase length of time required for mating).
    4. Subchronic toxicity. Subchronic toxicity studies have been 
conducted with kasugamycin in the rat, mouse, and dog.
    i. Rats. Kasugamycin technical was tested in rats in a 13-week 
feeding study. Observations were altered blood biochemistry, elevated 
absolute and relative cecum weights, and increased relative kidney 
weights. Both males and females at the high dose increased their water 
consumption compared to controls. In addition, males in the 6,000 ppm 
group had an increase in eosinophilic bodies in the proximal tubule 
cells of the kidney and the females had an increase in foam cell 
aggregation in the lungs. Foam cells generally contained lipid droplets 
and may be derived from macrophage. The NOEL is 300 ppm (17.53 mg/kg/
day in males and 22.33 mg/kg/day in females)
    ii. Mice. A 13-week feeding study in mice was conducted. Effects 
included ulceration and inflammation of the anus, altered 
hematological, and clinical chemistry. Females in the 10,000 ppm group 
had a diffuse basophilia and hyperplasia of the epithelium of the 
proximal tubule of the kidney. Dilatation of the seminiferous tubules 
of males was observed in the high-dose group and sometimes associated 
with degeneration of the seminiferous epithelium. The NOEL is 1,000 ppm 
(135.4 mg/kg/day in males and 170.9 mg/kg/day in females).
    iii. Dog. A 13-week oral toxicity study was conducted in beagle 
dogs. Effects included decreased food consumption and body weight gain, 
discolored feces, tongue lesions, swollen mouth, and excessive 
salivation. The NOEL is 300 ppm (10.59 mg/kg/day in males and 11.44 mg/
kg/day in females).
    5. Chronic toxicity. Kasugamycin has been tested in chronic studies 
with dogs, rats, and mice.
    i. Rats. In a 24-month combined chronic/oncogenicity study in rats 
findings were increased cecum weights and kidney weights, increased 
brown pigment deposition in the kidney proximal tubules and an 
increased incidence of foam cell aggregation in the lungs. No 
significant increase in neoplastic lesions. The NOEL is 300 ppm (10.59 
mg/kg/day in males and 11.44 mg/kg/day in females).
    ii. Mice. Kasugamycin was administered in diet to mice for 78 
weeks. Observations were lower absolute and relative spleen weights for 
males at 1,500 ppm. The NOEL is 300 ppm (34.94 mg/kg/day in males and 
42.49 mg/kg/day in females)
    iii. Dog. Kasugamycin was administered for 52 weeks to dogs. The 
administration of 3,000 ppm kasugamycin was associated with minimally 
higher urea nitrogen and creatinine, lower urine volume, and higher 
urine specific gravity. The NOEL is 1,000 ppm.
    iv. Carcinogenicity. Kasugamycin did not produce carcinogenicity in 
adequately designed chronic studies with rats or mice. Arvesta 
Corporation anticipates that the cancer classification of kasugamycin 
will be ``E'' (no evidence of carcinogenicity for humans).
    6. Animal metabolism. Following administration to the rodent, the 
majority of kasugamycin is excreted into the feces, a small amount was 
eliminated in the urine, and less than 0.1% of the radioactivity was 
retained in the carcass. Kasugamycin is not excreted in the bile and 
enterohepatic circulation of kasugamycin does not occur. There were no 
apparent sex related differences.
    7. Metabolite toxicology. No metabolites of significant expected 
toxicity were identified in the animal metabolism study.
    8. Endocrine disruption. Data from the subchronic studies indicate 
that there is no expected endocrine disruption effects.

C. Aggregate Exposure

    1. Dietary exposure. Acute and chronic dietary analyses were 
conducted to estimate exposure to potential kasugamycin residues in or 
on the following crops: Fruiting vegetables using CARES software 
developed by CropLife and DietRisk\TM\ TSG's software. Kasugamycin is 
not used in the United States so there is no need for water exposure 
analysis. In calculating the exposure the following assumptions were 
made: Tolerance level of residues, and 100% imported crops treated with 
kasugamycin.
    2. Food--i. The acute dietary margin of exposure (MOE) estimates 
for kasugamycin residues in food at 99.9\th\ percentile of females age 
13-49 is higher

[[Page 18001]]

than 12,000 based on a NOEL of 3 mg/kg/day from the developmental 
toxicity study. The acute dietary exposure to kasugamycin for this 
group is less than 1% of the reference dose (RfD) which was defined as 
the NOEL from the developmental study in rabbits including an 
uncertainty factor of 100 (NOEL = 3 mg/kg/day, RfD = 0.03 mg/kg/day).
    ii. Chronic dietary exposure to kasugamycin residues of females age 
13-49 was less than 0.1% of the chronic RfD. The RfD was defined as the 
NOEL from the developmental study in rabbits including an uncertainty 
factor of 100 (NOEL = 3 mg/kg/day, RfD = 0.03 mg/kg/day).
    These values are based on tolerance level residues and 100% 
imported crops treated with kasugamycin. These can be considered 
conservative values.

D. Cumulative Effects

     Section 408(b)(2)(D)(v) of FFDCA requires that the Agency must 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' Available information in this context 
includes not only toxicity, chemistry, and exposure data, but also 
scientific policies and methodologies for understanding common 
mechanism of toxicity and conducting cumulative risk assessments. For 
most pesticides, although the Agency has some information in its files 
that may turn out to be helpful in eventually determining whether a 
pesticide shares a common mechanism of toxicity with any other 
substances, EPA does not at this time have methodologies to resolve the 
complex scientific issues concerning common mechanism of toxicity in a 
meaningful way for most registered pesticides. However, the mode of 
action of kasugamycin differs substantially from those of other 
aminoglycoside antibiotics. Because kasugamycin acts at a different 
point in protein syntheses than that affected by other aminoglycoside 
antibiotics, cross-resistance between kasugamycin and other similar 
antibiotics is extremely unlikely. In addition, kasugamycin is active 
only against phytopathogenic fungi and bacteria. Because kasugamycin is 
not effective against common human or animal pathogens, it has never 
been employed as a human or veterinary-use antibiotic. For the same 
reason, there is essentially no possibility that use of kasugamycin as 
a plant protection agent can give rise to antibiotic resistance in 
human or animal pathogens.

E. Safety Determination

    1. U.S. population. Using the conservative assumptions of tolerance 
level residues and 100% of imported crops treated with kasugamycin, 
based on the completeness and reliability of the toxicity data, it is 
concluded that dietary exposure to proposed uses of kasugamycin will 
utilize less than 0.1% of the chronic RfD and less than 1% of the acute 
RfD for the females of childbearing age population group, the most 
sensitive group, and is likely to be much less, as more realistic data 
and models are developed. The MOE from the dietary exposure for the 
same group is higher than 12,000 and is likely to be higher, as more 
realistic data and models are developed. The Agency has no cause for 
concern if total acute residue contribution is less than 100% of the 
acute RfD, because the RfD represents the level at or below which daily 
exposure over a lifetime will not pose appreciable risk to human 
health. Therefore, there is a reasonable certainty that no harm will 
occur to the U.S. population from dietary exposure to residues of 
kasugamycin.
    2. Infants and children. The toxicological database for evaluating 
pre- and post-natal toxicity for kasugamycin is complete with respect 
to current data requirements. There are no special pre- and post-natal 
toxicity for infants and children, based on the results of the rat and 
rabbit developmental toxicity studies or the 2-generation reproductive 
toxicity study in rats. In all cases there were no developmental and 
offspring toxicity effects at the maternal toxicity level. Using the 
conservative assumption described in Unit E.1., based on the 
completeness and reliability of the toxicity data, it is concluded that 
the exposure to the proposed uses of kasugamycin on imported crops will 
utilize at most 1.0% of the acute or chronic RfD. Therefore, there is a 
reasonable certainty that no harm will occur to infants and children 
from exposure to residues of kasugamycin.

F. International Tolerances

    CODEX Maximum Residue Limits (MRLs) have not been established for 
kasugamycin in either tomato or peppers, and a joint meeting on 
pesticide residues (JMPR) review of kasugamycin residue data is not 
scheduled. Spain has established an MRL for kasugamycin in tomato, at 
0.05 ppm. There are no existing MRLs for kasugamycin in pepper.

[FR Doc. 05-6848 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S