[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43421-43424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14606]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0207; FRL-7727-8]


Orthosulfamuron; 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-
2005-0207, must be received on or before August 26, 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: Jim Tompkins, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5697; 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 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-2005-0207. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or

[[Page 43422]]

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-2005-0207. 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-2005-0207. 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-2005-0207.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0207. 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.


[[Page 43423]]


    Dated: July 18, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

ISAGRO S.p.A.

PP 5F 6957

    EPA has received a pesticide petition (5F 6957) from ISAGRO 
S.p.A.,Centro Uffici S. Siro -- Fabbricato D -- ALA 3, Via Caldera, 21, 
20153 Milano, Italy 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 
orthosulfamuron in or on the raw agricultural commodity rice, grain and 
rice, straw at 0.05 parts per million (ppm). EPA has determined that 
the petition contains data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. In plants, the metabolism of orthosulfamuron 
is adequately understood for the purposes of establishing the proposed 
tolerances. Trace levels of parent orthosulfamuron were the predominant 
residue. In addition, several identified metabolites were found at very 
low concentrations. All residues (parent and metabolites) found in the 
plant metabolism studies were also found in the animal metabolism 
studies. Based on the available metabolism data, parent orthosulfamuron 
is proposed to be considered as the residue of concern in plant 
matrices.
    2. Analytical method. In plants, the residue of concern, parent 
orthosulfamuron, can be determined using High Pressure Liquid 
Chromatography (HPLC) with a Mass Spectrometer (MS) detector. The 
proposed limit of detection (LOD) and limit of quantitation (LOQ) for 
the method are 0.03 ppm and 0.05 ppm, respectively.
    3. Magnitude of residues. For rice, a total of twenty residue 
trials were conducted to evaluate the magnitude of the residues of 
orthosulfamuron. Of the twenty trials, fourteen were conducted using 
the 50WDG (water dispersible granule) formulation and six were 
conducted using the 50WP (wettable powder) formulation. In all trials, 
the rice was treated with orthosulfamuron at a rate of 75 grams of 
active ingredient (a.i.) per hectare, which is equivalent to 0.067 
pounds of a.i. per acre. No orthosulfamuron residues above the limit of 
detection of 0.02 ppm were found in any rice grain or straw sample 
treated with either the WDG or WP formulations. The rice processing 
study conducted at the exaggerated rate of 3X showed no detectable 
residues and therefore indicated no concentration in any processed rice 
commodities (polished rice, hulls, and bran).

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 was > 5,000 
milligrams/kilogram body weight (mg/kg bw) for both male and female 
rats. The acute dermal LD50 was > 5,000 mg/kg bw for both 
male and female rats. The 4-hour inhalation LC50 was 
estimated to be greater than the highest technically achievable 
gravimetrically determined aerosol concentration of 2.19 mg per liter 
for male and female rats. Orthosulfamuron was non-irritating to rabbit 
skin, slightly irritating to rabbit eyes, and did not cause skin 
sensitization in guinea pigs.
    2. Genotoxicity. Numerous mutagenicity studies were conducted with 
orthosulfamuron and no genotoxic effects were reported.
    3. Reproductive and developmental toxicity. In a two generation 
reproduction study, rats were administered dietary concentrations of 0, 
22.2, 88.6, and 354.5 mg per kilogram body weight (mg/kg bw) for males 
and 0, 25.6, 102.2, and 408.8 mg/kg bw for females. These dietary 
concentrations correspond to 0, 350/225, 1,400/900, and 5,600/3,600 
ppm. The no observed effect level (NOEL) for effects in the P and F1 
generation adults was considered to be 1,400/900 ppm based on increased 
liver and kidney weights and accompanying histopathological changes, 
while the NOEL for reproductive and developmental effects was 
considered to be 5,600/3,600 ppm based on the absence of reproductive 
and developmental effects, while the NOEL for pup behavior was 
considered to be 1400/900 ppm based on reduced locomotor activity in 
the F1 male offspring.
    Developmental toxicity studies were conducted in female rats and 
rabbits. A developmental toxicity study was conducted in female rats 
with orthosulfamuron using dose levels administered by gavage of 0, 
100, 300, and 1,000 mg/kg bw. The NOEL was established at 100 mg/kg bw 
for maternal toxicity based on decreased body weight gain and at 1,000 
mg/kg bw based on the absence of fetal and developmental effects. In 
the developmental toxicity study conducted in female rabbits, the dose 
levels administered by gavage were 0, 25, 75, and 250 mg/kg bw. The 
NOEL for maternal toxicity is established at 250 mg/kg bw, while the 
NOEL for developmental effects is 75 mg/kg bw based on slight 
developmental changes.
    Developmental toxicity studies showed no primary developmental 
toxicity and no teratogenic potential was evident.
    4. Subchronic toxicity. 90-day feeding studies were conducted in 
rats and dogs. The rat study was conducted at dietary concentrations of 
0, 19, 113, and 706 mg/kg bw and the dog study was conducted at 0, 150, 
450, and 1,000 mg/kg bw. The NOELs were established at 113 mg/kg bw for 
the rat based on effects in the liver and at 150 mg/kg bw for the dog 
based on liver and hematological effects. In addition, a preliminary 
90-day feeding study was conducted in mice at dietary concentrations of 
0, 36, 187, and 865 mg/kg bw for males and 0, 47, 228, and 1,096 mk/kg 
bw for females. The NOEL for this study was 187 mg/kg bw for males and 
228 mg/kg bw for females based on body weight gain depression.
    5. Chronic toxicity. A two year combined rat chronic/oncogenicity 
study at dietary concentrations of 0, 1, 5, 500, and 1,000 mg/kg bw 
demonstrated a NOEL of 5 mg/kg bw based on increased thyroid, liver, 
and kidney toxicity. A 78-week mouse oncogenicity study conducted at 
dietary concentrations of 0, 100, 500, and 1,000 mg/kg bw demonstrated 
a NOEL of 100 mg/kg bw for males and 1,000 mg/kg bw for females. The 
NOEL of 100 mg/kg bw for males was based on liver effects. No evidence 
of oncogencity was observed in the rat or the mouse. A 52-week chronic 
toxicity study in dogs conducted at dietary levels of 0, 75, 300, and 
1,000 mg/kg bw demonstrated a NOEL of 75 mg/kg bw based on increased 
liver toxicity.
    6. Animal metabolism. The nature of the orthosulfamuron residue in 
animals is adequately understood. Orthosulfamuron is extensively

[[Page 43424]]

metabolized very quickly and eliminated from the body by fecal and 
urinary routes.
    7. Metabolite toxicology . IR5878 is extensively metabolized and 
quickly cleared from the body. Low dose single administration was 5 mg/
kg bw and high was 1,000 mg/kg bw, and repeated doses at low dose was 5 
mg/kg bw. Single low and high dose, as well as repeated low dose 
excretion was mainly via feces. Radioactivity was almost completely 
excreted via urine by 24 hours post dose and via feces by 48 hours post 
dosing. Excretion patterns following the three dose administrations 
were not markedly different, and there was no difference due to sex. 
Metabolites included at least 9 compounds. Metabolic profiles were 
almost the same following single oral low and high administration, and 
repeated oral administration, although the amounts of some compounds 
were different especially between low and high doses. The metabolic 
profiles for males and females were the same. Identical metabolites 
were found both in urine and feces. The identity of metabolites found 
showed that IR5878 was metabolized mainly by O-demethylation yielding 
compound C6, N-demethylation yielding compound 
C5, O and N-demethylations yielding compound C4 
and hydrolytic cleavage of the sulfamoylurea linkage yielding compounds 
C3, C8 and C9.
    8. Endocrine disruption. Orthosulfamuron did not have any effects 
on endocrine organs or tissues except in the rat at very high doses. In 
addition, there were no indications of effects on fetal developmental 
in either rats or rabbits, or on reproductive performance in rats. 
Therefore, at doses likely to be encountered, orthosulfamuron is not 
likely to be an endocrine disruptor.

C. Aggregate Exposure

    1. Dietary exposure. The chronic reference dose (cRfD) and the 
acute reference dose (aRfD) of 0.05 mg/kg bw and 1.65 mg/kg bw, 
respectively, were used to assess chronic and acute dietary exposure. 
ISAGRO has conducted Tier 1 chronic and acute risk assessments which 
indicate that the highest chronic and acute exposure estimates never 
exceed 0.13% and 0.01% (at the 95th percentile of exposure) 
for the chronic and acute RFDs, respectively.
    i. Food. The chronic reference dose (cRfD) and the acute reference 
dose (aRfD) of 0.05 mg/kg bw and 1.65 mg/kg bw, respectively, were used 
to assess chronic and acute dietary exposure. ISAGRO has conducted Tier 
1 chronic and acute risk assessments which indicate that the highest 
chronic and acute exposure estimates never exceed 0.13% and 0.01% (at 
the 95th percentile of exposure) for the chronic and acute 
RFDs, respectively.
    ii. Drinking water. For drinking water, the FIRST model (FQPA Index 
Reservoir Screening Tool) was used to conservatively estimate 
concentrations of orthosulfamuron in surface water. The chronic and 
acute drinking water estimated concentrations (DWECs) estimated with 
the FIRST model were 0.35 ppb (chronic) and 4.8 ppb (acute). These 
compare very favorably to the lowest drinking water level of comparison 
(DWLOC) values of 500 ppb (chronic) and 16,498 ppb (acute).
    2. Non-dietary exposure. Orthosulfamuron is currently not 
registered for use on any residential non-food site. Therefore, 
residential exposure to orthosulfamuron residues will be through 
dietary exposure only.

D. Cumulative Effects

    There is no information currently available to indicate that toxic 
effects produced by orthosulfamuron are cumulative with those of any 
other compound.

E. Safety Determination

    1. U.S. population. Based on the conservative exposure assumptions 
described above and on the completeness of the toxicology database, it 
can be concluded that total aggregate exposure from food and water to 
the U.S. population and all evaluated population subgroups from 
orthosulfamuron from all proposed uses will be well below the chronic 
and acute RfDs. EPA generally has no concerns for estimated exposures 
below 100% of the RfD, since the RfD represents the level at or below 
which daily aggregate exposure will not pose an appreciable risk to 
human health. Thus, ISAGRO believes it can be concluded that there is 
reasonable certainty that no harm will result from aggregate exposure 
to orthosulfamuron residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of orthosulfamuron, the 
data from developmental toxicity studies in both the rat and rabbit and 
a two generation reproduction study in rats have been considered. The 
developmental toxicity studies evaluate potential adverse effects on 
the developing animal resulting from pesticide exposure to the mother 
during prenatal development. The reproduction study evaluates effects 
from exposure to the pesticide on the reproductive capability of mating 
animals through two generations, as well as any observed systemic 
toxicity.
    Since none of the studies indicate the offspring to be more 
sensitive and all effects were secondary to severe maternal toxicity, 
ISAGRO believes that infants and children are protected and that an 
additional uncertainty factor for infants and children is not 
warranted.

F. International Tolerances

    No CODEX maximum residue levels (MRL's) have been established for 
residues of orthosulfamuron on any crops at this time.
[FR Doc. 05-14606 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S