[Federal Register Volume 70, Number 104 (Wednesday, June 1, 2005)]
[Notices]
[Pages 31459-31462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10842]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0135; FRL-7715-7]


Furilazole; 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 (PP) by Monsanto Company proposing the establishment of 
regulations for residues of 3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine (furilazole) (safener) in or on the raw 
agricultural commodities sorghum grain, forage, stover, flour, and bran 
at 0.01 parts per million.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0135, must be received on or before July 1, 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: Karen Angulo, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; 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

[[Page 31460]]

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-2005-0135. 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, 1801S. 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 
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-2005-0135. 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-2005-0135. 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,

[[Page 31461]]

DC 20460-0001, Attention: Docket ID Number OPP-2005-0135.
    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-2005-0135. 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: May 23, 2005.

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 Monsanto Company and represents the view of the petitioner. 
EPA is publishing the petition summary verbatim without editing it in 
anyway. 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.

Monsanto Company

PP 5E6919

    EPA has received PP 5E6919 from Monsanto Company, 800 N. Lindbergh 
Blvd., St. Louis, MO 63167, proposing, pursuant to section 408(d) of 
the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing 
a tolerance for residues of 3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine (furilazole) in or on the raw agricultural 
commodities sorghum grain, forage, stover, flour, and bran at 0.01 
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. The metabolism of furilazole in sorghum was 
examined in a field study in which uptake and metabolism of 
radiolabeled furilazole in sorghum and corn was determined in parallel 
experiments. Parent furilazole was not found in any of the sorghum 
samples. Furilazole is rapidly and extensively metabolized to a large 
number of highly polar metabolites characterized as weak organic acids 
or residues conjugated to natural sugars.
    2. Analytical method. Monsanto has developed an analytical method 
using gas liquid chromatography/mass spectrometry with selected ion 
monitoring that has a verified limit of quantitation of 0.01 ppm for 
parent furilazole in sorghum grain, forage, stover, flour, and bran. 
This method is analogous to that validated by the Agency with the 
exception of the use of a mass-specific detector rather than an 
electron capture detector.
    3. Magnitude of residues. Monsanto has conducted a residue field 
study with furilazole applied pre-emergence and early post-emergence to 
sorghum according to label use rates per acre. Analysis of sorghum 
forage, stover, grain, flour and bran showed no residues with an 
analytical method that was validated at the lower limit of 0.01 ppm.

B. Toxicological Profile

    A summary of the toxicology data submitted to support this 
tolerance petition was published in the Federal Register on April 3, 
2002 (67 FR 15727) (FRL-6828-4).

C. Aggregate Exposure

    1. Dietary exposure --i. Food. Furilazole is currently registered 
for use only on corn. Tolerances for sorghum are proposed as part of 
this petition. Potential acute and chronic dietary exposures resulting 
from the use of furilazole on corn and sorghum were estimated using the 
Dietary Exposure Evaluation Model - Food Consumption Intake Database 
(DEEM-FCID\TM\, version 2.03, Exponent, Inc.). Food consumption was 
based on data from the 1994-1996 USDA Continuing Surveys of Individual 
Intakes (CSFII)

[[Page 31462]]

and the 1998 Supplemental Children's Survey. For the purposes of this 
document, Monsanto made the very conservative assumption that the 
entire corn and sorghum crops were treated with furilazole (i.e., 100% 
crop treated), that all corn and sorghum commodities contained residues 
of furilazole at the existing or proposed tolerance levels, and that no 
losses occurred during storage, processing or cooking.
    ii. Drinking water. Insufficient monitoring data are available for 
a comprehensive risk assessment of furilazole residues in drinking 
water. However, the EPA has previously used the Pesticide Root Zone/
Exposure Analysis Modeling System (PRZM/EXAMS) and Screening 
Concentrations in Ground Water (SCI-GROW) models to develop 
conservative estimates of potential furilazole concentrations in 
surface and shallow ground water, respectively as published in the 
Federal Register of April 3, 2002 (67 FR 15727). For surface water, the 
Agency calculated Estimated Environmental Concentrations (EECs) of 1.2 
parts per billion (ppb), 0.8 ppb and 0.22 ppb for acute, chronic (non-
cancer) and cancer risk assessments, respectively. For ground water, 
the Agency calculated an EEC of 0.02 ppb for all exposure scenarios. To 
assess potential health risks associated with possible residues of 
furilazole in drinking water, Monsanto compared these EECs to drinking 
water levels of concern (DWLOC), which were calculated by subtracting 
the estimated exposures to furilazole from food from the appropriate 
Reference Dose (RfD), and making standard assumptions regarding 
drinking water consumption and body weights for adults and children.
    2. Non-dietary exposure. There are no residential or non-
agricultural uses of furilazole. Therefore, non-dietary, non-
occupational exposures to furilazole are expected to be negligible and 
were not included within this risk assessment.

D. Cumulative Effects

    Monsanto has no reliable data or information to suggest that 
furilazole shares a common mechanism of toxicity with any other 
chemical. Therefore, only the potential effects of furilazole are 
addressed in this document.

E. Safety Determination

    1. U.S. population. The toxicology endpoints used to assess 
potential acute, chronic and carcinogenic risks from furilazole were 
those previously identified by the EPA and published in the Federal 
Register on April 3, 2002 (67 FR 15727). Acute dietary risks were 
assessed using an acute reference dose (RfD) of 0.1 milligrams/
kilograms (mg/kg)/day. This was based on a no observed adverse effect 
level (NOAEL) of 10 mg/kg/day for increased resorptions in a 
developmental toxicity study in rats and a 100-fold uncertainty factor 
(UF). The only population subgroup of potential concern for this effect 
was females aged 13 and older because this is an in-utero effect 
applicable only to females of childbearing age. Acute risk assessments 
for other population subgroups were not conducted since no other acute 
toxicology endpoint was identified.
    Potential risks for chronic toxicity to all population subgroups 
were assessed using a chronic reference dose (cRfD) of 0.0009 mg/kg/
day. This was based on a NOAEL of 0.26 mg/kg/day for increased liver 
and kidney weights in a chronic rat study and an UF of 300. This UF 
included an extra 3X to account for the lack of a one-year dog study. 
Since furilazole is classified by the EPA as ``likely to be 
carcinogenic to humans'', potential carcinogenic risks have been 
quantified using the cancer slope factor (Q*) of 0.0274 (mg/kg/
day)-\1\ previously used by EPA.
    With the exception of a lack of a one-year dog study, the 
toxicology and exposure information available for furilazole was 
considered to be valid, reliable and complete according to current 
regulatory standards. No evidence of increased susceptibility of 
offspring was noted in rats or rabbits following in utero and/or 
postnatal exposure to furilazole. Therefore, the Agency has determined 
that no additional Food Quality Protection Act (FQPA) safety factor was 
needed to protect infants or children.
    2. Acute risk. Based on the above assumptions, the 99th percentile 
for acute dietary (food) exposure to furilazole for females aged 13 to 
50 was estimated to be 0.000095 mg/kg/day. This exposure represents 
0.09% of the RfD. In general, exposures utilizing less than 100% of the 
RfD are not of concern. The DWLOC calculated for this scenario was 3000 
ppb, which is far above the acute EECs of 1.2 ppb for surface water and 
0.02 ppb for ground water calculated by the EPA. Therefore, Monsanto 
concludes that there is a reasonable certainty that acute dietary 
exposure to furilazole will not pose a significant risk to human 
health.
    3. Chronic risk. Based on the above assumptions, chronic dietary 
exposure to furilazole from food for the overall U.S. population was 
estimated to be 0.000014 mg/kg/day. This represents about 1.5% of the 
cRfD. Chronic dietary exposure from food for children 3-5, the most 
highly exposed population subgroup, was estimated to be 0.000032 mg/kg/
day, which represents 3.6% of the cRfD. Both of these values are well 
below 100% of the RfD. In addition, the chronic DWLOCs for the overall 
U.S. population and children were calculated to be 31 and 8.7 ppb, 
which are greater than the chronic EECs of 0.8 ppb for surface water 
and 0.02 ppb for ground water calculated by the Agency. Therefore, 
Monsanto concludes that there is a reasonable certainty that chronic 
dietary exposure to furilazole will not pose a significant risk to 
human health.
    4. Cancer risk. Based on the above assumptions, the average daily 
lifetime exposure to furilazole from food for the overall U.S. 
population was estimated to be 0.000014 mg/kg/day. Using linear low-
dose extrapolation, the 95% upper confidence limit of the lifetime 
cancer risk associated with this level of exposure was estimated to be 
3.7 x 10-\7\. Cancer risks of less than 1 x 
10-\6\ are generally considered to be negligible. The DWLOC 
for carcinogenic risks to the overall U.S. population was calculated to 
be 0.8 ppb, which is greater than the EECs of 0.22 ppb for surface 
water and 0.02 ppb for ground water calculated by EPA for use in cancer 
risk assessment. Therefore, Monsanto concludes that there is a 
reasonable certainty that lifetime aggregate exposure to furilazole 
will not pose a significant risk of cancer.
    5. Overall conclusion of safety. Based on the data summarized 
herein, Monsanto concludes that there is a reasonable certainty that no 
harm will result to the U.S. population, including infants and 
children, from the current and proposed uses of furilazole.

F. International Tolerances

    The Codex Alimentarius Commission has not established a maximum 
residue level for furilazole.

[FR Doc. 05-10842 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S