[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46619-46623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19915]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0234; FRL-7317-6]


Benoxacor; 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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[[Page 46620]]

SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certainpesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2003-0234, must be received on or before September 5, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, orthrough 
hand delivery/courier. Follow the detailed instructions asprovided in 
Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC20460-0001; telephone 
number: (703) 305-6304; 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 
anagricultural producer, food manufacturer, or pesticide 
manufacturer.Potentially affected entities may include, but are not 
limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather providesa 
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) 
codeshave been provided to assist you and others in determining 
whetherthis action might apply to certain entities. If you have any 
questionsregarding the applicability of this action to a particular 
entity, consultthe person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2003-0234. 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 
officialpublic docket, and to access those documents in the public 
docket thatare available electronically. Although not all docket 
materials may beavailable electronically, you may still access any of 
the publiclyavailable docket materials through the docket facility 
identified in UnitI.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 EPA's 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 inEPA's electronic public docket but will be available only in 
printed,paper form in the official public docket. To the extent 
feasible, publiclyavailable docket materials will be made available in 
EPA's electronicpublic docket. When a document is selected from the 
index list in EPADockets, the system will identify whether the document 
is available forviewing in EPA's electronic public docket. Although not 
all docketmaterials may be available electronically, you may still 
access any ofthe publicly available docket materials through the docket 
facilityidentified in Unit I.B.1. EPA intends to work towards 
providingelectronic access to all of the publicly available docket 
materialsthrough EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policyis 
that public comments, whether submitted electronically or in paper,will 
be made available for public viewing in EPA's electronic publicdocket 
as EPA receives them and without change, unless the commentcontains 
copyrighted material, CBI, or other information whosedisclosure is 
restricted by statute. When EPA identifies a commentcontaining 
copyrighted material, EPA will provide a reference to thatmaterial in 
the version of the comment that is placed in EPA'selectronic public 
docket. The entire printed comment, including thecopyrighted material, 
will be available in the public docket.Public comments submitted on 
computer disks that are mailed ordelivered to the docket will be 
transferred to EPA's electronic publicdocket.
    Public comments that are mailed or delivered to the docket willbe 
scanned and placed in EPA's electronic public docket. Wherepractical, 
physical objects will be photographed, and the photographwill be placed 
in EPA's electronic public docket along with a briefdescription written 
by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through 
handdelivery/courier. To ensure proper receipt by EPA, identify 
theappropriate docket ID number in the subject line on the first page 
ofyour comment. Please ensure that your comments are submitted 
withinthe specified comment period. Comments received after the close 
of thecomment period will be marked ``late.'' EPA is not required to 
consider these late comments. If you wish to submit CBI or information 
that isotherwise protected by statute, please follow the instructions 
in UnitI.D. Do not use EPA dockets or e-mail to submit CBI or 
informationprotected 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 
outsideof 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

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provided in the body of a comment will beincluded as part of the 
comment that is placed in the official publicdocket, and made available 
in EPA's electronic public docket. If EPAcannot read your comment due 
to technical difficulties and cannotcontact you for clarification, EPA 
may not be able to consider yourcomment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method 
forreceiving comments. Go directly to EPA Dockets at http://www.epa.gov/ edocket, and follow the online instructions for submitting 
comments. Once in the system, select ``search,'' and then key in docket 
ID number OPP-2003-0234. The system is an ``anonymous access'' system, 
which means EPA will not know your identity, e-mail address, or other 
contact information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2003-0234. 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 addressesthat 
are automatically captured by EPA's e-mail system are includedas part 
of the comment that is placed in the official public docket, andmade 
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 
fileformat. Avoid the use of special characters and any form of 
encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs 
(OPP),Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0234.
    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, CrystalMall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: 
DocketID Number OPP-2003-0234. Such deliveries are only accepted 
duringthe 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 CBIelectronically 
through EPA's electronic public docket or by e-mail. Youmay claim 
information that you submit to EPA as CBI by marking anypart or all of 
that information as CBI (if you submit CBI on disk or CDROM, mark the 
outside of the disk or CD ROM as CBI and then identifyelectronically 
within the disk or CD ROM the specific information thatis CBI). 
Information so marked will not be disclosed except inaccordance with 
procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includesany 
information claimed as CBI, a copy of the comment that does notcontain 
the information claimed as CBI must be submitted for inclusionin the 
public docket and EPA's electronic public docket. If you submitthe copy 
that does not contain CBI on disk or CD ROM, mark theoutside of the 
disk or CD ROM clearly that it does not contain CBI.Information not 
marked as CBI will be included in the public docketand EPA's electronic 
public docket without prior notice. If you haveany questions about CBI 
or the procedures for claiming CBI, pleaseconsult 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 
yourcomments:
    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 
usedthat support your views.
    4. If you estimate potential burden or costs, explain how 
youarrived 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 thisnotice.
    7. To ensure proper receipt by EPA, be sure to identify the 
docketID number assigned to this action in the subject line on the 
first pageof 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 
theestablishment and/or amendment of regulations for residues of a 
certainpesticide chemical in or on various food commodities under 
section 408of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a.EPA has determined that this petition contains data or 
informationregarding the elements set forth in FFDCA section 408(d)(2); 
however,EPA has not fully evaluated the sufficiency of the submitted 
data atthis 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, Feedadditives, 
Food additives, Pesticides and pests, Reporting andrecordkeeping 
requirements.

    Dated: July 22, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed 
belowas 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 summary may have been edited by EPA if the terminology 
usedwas unclear, the summary contained extraneous material, or 
thesummary unintentionally made the reader conclude that the 
findingsreflected EPA's position and not the position of the 
petitioner. Thepetition summary announces the availability of a 
description of theanalytical methods available to EPA for the detection 
and measurementof the pesticide chemical residues or an explanation of 
why no suchmethod is needed.

Syngenta Crop Protection

PP 7E3489

    EPA has received an amendment to pesticide petition (PP 7E3489)from 
Syngenta Crop Protection, 410 Swing Road, Greensboro, NC27419, 
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C.346a(d), to 
amend 40 CFR 180.460 to establish the use ofbenoxacor, (4-
(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1,4-benzoxazine)as an inert 
ingredient (safener) in pesticide formulations containing S-metolachlor 
in or on raw agricultural commodities (RACs) for whichtolerances have 
been established for S-metolachlor or that support S-metolachlor uses. 
The petitioner is not requesting a change in thelevel or the numerical 
tolerance, but is requesting that benoxacor only be used with S-
metolachlor, not metolachlor. EPA has

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determined that the request 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 thepetition. Additional data 
may be needed before EPA rules on thepetition.
    The Notice of Filing was published in the Federal Register on 
November 21, 1997 (62 FR 62304)(FRL-5755-2). The petitioner at that 
time was Novartis Crop Protection, Inc. In the Federal Register of 
February 13, 1998 (63 FR 7299) (FRL-5771-1), EPA published a final rule 
establishing tolerances for residues of benoxacor at 0.01 ppm for all 
commodities for which tolerances have been established for metochlor. 
No benoxacor risk assessments have been performed by the Agency since 
that time.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of benoxacor in plants and 
animals is adequately understood for purposes of these tolerances. 
Identified metabolic pathways are similar in plants and animals (goat, 
hen, and rat).
    2. Analytical method. Adequate enforcement methodology, 
gaschromatography/nitrogen phosphorous detection (GC/NPD), is 
availableto enforce the tolerance expression. An analytical methodology 
for thedetermination of benoxacor and its metabolites in plant and 
animalcommodities (Syngenta Analytical Method AG536(C)) is available 
uponrequest from EPA. Analytical Method AG536c involves 
extraction,filtering, dilution, partitioning, and cleanup. Samples are 
then analyzedby capillary gas chromatography using N/P detection. The 
limit ofquantitation (LOQ) is 0.01 ppm.
    3. Magnitude of residues. The magnitude of the residue in plants is 
adequately understood for the purposes of these tolerances. Morethan 30 
residue trials were conducted in 19 States on a variety ofagricultural 
crops, corn (field and sweet); soybeans, potatoes, greenbeans, 
radishes, sorghum, peanuts, head lettuce, and peas. There wereno 
detectable residues of benoxacor at the LOQ of 0.01 ppm (manysamples 
were analyzed at an LOQ of 0.005 ppm and no residues weredetected) in 
any RAC or processed commodity. No transfer of residueto animals is 
expected through their diet.

B. Toxicological Profile

    The toxicological profile of benoxacor and the end points for usein 
risk assessments are discussed in the final rule published in the 
Federal Register of February 13, 1998 (63 FR 7299) (FRL-5771-1).

C. Aggregate Exposure

    1. Dietary exposure.--i. Food. Tolerances have been established (40 
CFR 180.460) for the residues of benoxacor in or on a variety of RACs. 
Risk assessments were conducted by EPA to assess dietary exposures and 
risks from benoxacor. In this action, Syngenta Crop Protection is 
requesting to amend only the tolerance expression and therefore 
believes that the most recent Food Quality Protection Act (FQPA) 
dietary assessment completed by EPA is valid in the consideration of 
this amendmentrequest.
    ii. Acute exposure and risk. Since there are no acute toxicological 
concerns for benoxacor, EPA has previously determined that an acute 
dietary risk assessment was not required.
    iii. Chronic exposure and risk. For the purpose of assessing 
chronic dietary exposure from benoxacor, EPA has previously considered 
the established benoxacor tolerance of 0.01 ppm and the RACs for which 
tolerances have been established for metolachlor. There are no 
otherestablished U.S. tolerances for benoxacor, and there are no 
otherregistered uses for benoxacor on food or feed crops in the United 
States.Benoxacor is used currently only as a herbicide safener in end-
useproduct formulations that contain S-metolachlor. There are no 
longerany registrations of other active ingredients that contain 
benoxacor.
    In conducting this exposure assessment, EPA previously 
assumedtolerance level residues and 100% crop treated, resulting in a 
largeoverestimation of dietary exposure and protective of any chronic 
dietaryexposure scenario. The chronic reference dose (cRfD) is 
0.004milligram/kilogram/day (mg/kg/day). Based on the chronic 
dietaryexposure of 0.000205 mg/kg/day for the U.S. population and 
0.000828mg/kg/day for the most highly exposed population subgroup 
(nonnursinginfants less than 1-year old), this chronic dietary 
riskassessment resulted in the use of 5.13% of the RfD for the 
U.S.population and 20.7% of the RfD for the most highly 
exposedpopulation subgroup. A cancer dietary margin of exposure (MOE) 
wascalculated to be 1,950 using 0.4 mg/kg/day as the point of 
departure.
    iv. Drinking water. For the purposes of assessing chronic exposure 
in drinking water, EPA has previously considered the registered usesand 
the available data on persistence and mobility for benoxacor. TheAgency 
has determined through a qualitative risk assessment that thephysical 
and chemical characteristics of benoxacor are such that it isnot 
expected to impact water resources. While benoxacor has thepotential to 
be mobile, it is not persistent (half-life in soil of 49 daysunder 
aerobic conditions and 70 days anaerobically). In light of 
thesefindings, EPA has previously determined that benoxacor's use as 
asafener in S-metolachlor formulations will not impact ground water 
orsurface water resources, and therefore, is not expected to lead 
toexposure to humans through drinking water.
    2. Non-dietary exposure. All registered S-metolachlor products to 
which benoxacor is added as a safener are commercial 
agriculturalproducts not registered for residential use. The potential 
for nonoccupationalexposure to benoxacor by the general population is 
therefore unlikely except for the potential residues in food crops 
discussed above.

D. Cumulative Effects

    EPA has previously determined that a cumulative assessment is 
notrequired for benoxacor. Benoxacor does not share a common mode 
oftoxicity with any other moiety regulated by EPA further supporting 
thelack of a need for conducting a cumulative assessment in relation 
tothis requested tolerance amendment.

E. Safety Determination

    1. U.S. population--i. Acute risk. Since there are no acute 
toxicological concerns for benoxacor, EPA has no cause for concern for 
acute aggregate exposure.
    ii. Chronic risk. EPA has previously concluded that aggregate 
chronic exposure to benoxacor from food and water will utilize 5.13%of 
the RfD for the U.S. population. The major identifiable subgroup 
withthe highest aggregate exposure is non-nursing infants less than 1-
yearold (utilizing 20.7% of the RfD). EPA generally has no concern 
forexposures below 100% of the RfD because the RfD represents the 
levelat or below which daily aggregate dietary exposure over a lifetime 
willnot pose appreciable risks to human health. EPA does not expect 
theaggregate exposure to exceed 100% of the RfD. EPA has 
previouslyconcluded that there is a reasonable certainty that no harm 
will resultfrom aggregate exposure to benoxacor residues.
    The carcinogenic risk from food uses of benoxacor for the general 
U.S. population was calculated previously by

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EPA by comparing the dietary exposure from benoxacor to the no observed 
adverse effect level (NOAEL) identified for use with the cancer risk 
assessment. Based on the NOAEL selected by EPA for cancer risk 
characterization of 0.4 mg/kg/day, the cancer risk was estimated to 
result in a MOE of 1,950 contributed through all the published uses for 
benoxacor. Based upon the extreme conservatism of the dietary exposure 
estimates and the fact that tumors were observed only at dose levels 
far in excess of the selected NOAEL, this MOE is at a level which the 
Agency does notconsider raising a concern for excess lifetime cancer.
    2. Infants and children. EPA has previously determined that the 
toxicological data base for evaluating prenatal and postnatal toxicity 
for benoxacor is complete with respect to current data requirements. 
Because both developmental and reproductive effects occurred in the 
presence of parental (systemic) toxicity, these data do not suggest 
anincreased prenatal or postnatal sensitivity of children and infants 
tobenoxacor exposure. Based on the above, EPA has previously 
concludedthat reliable data support use of a 100-fold MOE/uncertainty 
factor (UF),rather than the standard 1,000-fold margin/factor to 
protect infants andchildren. EPA concludes that there is a reasonable 
certainty that noharm will result to infants and children from 
aggregate exposure tobenoxacor residues.
    3. Acute risk. Since there are no acute toxicological concerns for 
benoxacor, EPA has no cause for concern for acute aggregate exposure.
    4. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has previously concluded that aggregate exposure 
to benoxacor from food will range from 3.69% of the RfD for females13+ 
years, to 20.7% of the RfD for non-nursing infants less than 1-yearold. 
EPA generally has no concern for exposures below 100% of theRfD because 
the RfD represents the level at or below which dailyaggregate dietary 
exposure over a lifetime will not pose appreciablerisks to human 
health. EPA does not expect the aggregate exposure toexceed 100% of the 
RfD. EPA has previously concluded that there isa reasonable certainty 
that no harm will result to infants and childrenfrom aggregate exposure 
to benoxacor residues.

F. International Tolerances

    No Codex maximum residue levels have been established forresidues 
of benoxacor.

[FR Doc. 03-19915 Filed 8-5-03; 8:45 am]
BILLING CODE 6560-50-S